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Sample records for cardiac outcomes trial

  1. Potential synergy between lipid-lowering and blood-pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial

    DEFF Research Database (Denmark)

    Sever, Peter; Dahlöf, Björn; Poulter, Neil

    2006-01-01

    A prespecified objective of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was to assess whether any synergistic effects were apparent between the lipid-lowering and blood-pressure-lowering regimens in preventing cardiovascular events....

  2. The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure

    DEFF Research Database (Denmark)

    Sever, Peter S; Poulter, Neil R; Dahlof, Bjorn

    2008-01-01

    Aims To determine the cardiovascular benefits in those originally assigned atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial-2.2 years after closure of the lipid-lowering arm of the trial (ASCOT-LLA). Methods and results The Blood Pressure Lowering Arm of the ASCOT trial (ASCOT......-BPLA) compared two different antihypertensive treatment strategies on cardiovascular outcomes. ASCOT-LLA was a double-blind placebo-controlled trial of atorvastatin in those enrolled into ASCOT-BPLA with total cholesterol concentrations at baseline of ... enrolled in ASCOT-BPLA and 10 305 were further assigned either atorvastatin, 10 mg, or placebo. ASCOT-LLA was stopped prematurely after a median 3.3 years follow-up because of substantial cardiovascular benefits in those assigned atorvastatin. Trial physicians were invited to offer atorvastatin to all...

  3. The Anglo-Scandinavian Cardiac Outcomes Trial: blood pressure-lowering limb: effects in patients with type II diabetes

    DEFF Research Database (Denmark)

    Ostergren, Jan; Poulter, Neil R; Sever, Peter S

    2008-01-01

    OBJECTIVE: To compare the effects of two antihypertensive treatment strategies for the prevention of coronary heart disease and other cardiovascular events in the large subpopulation (n=5137) with diabetes mellitus in the blood pressure-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial...... nonsignificantly by 8% (hazard ratio 0.92, confidence interval 0.74-1.15). CONCLUSION: In the large diabetic subgroup in the blood pressure-lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial, the benefits of amlodipine-based treatment, compared with atenolol-based treatment, on the incidence of total...... with addition of thiazide as required (atenolol-based). Therapy was titrated to achieve a target blood pressure of less than 130/80 mmHg. RESULTS: The trial was terminated early due to significant benefits on mortality and stroke associated with the amlodipine-based regimen. In patients with diabetes mellitus...

  4. Effect of Metoprolol Versus Carvedilol on Outcomes in MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy)

    DEFF Research Database (Denmark)

    Ruwald, Martin H; Ruwald, Anne-Christine H; Jøns, Christian

    2013-01-01

    This study sought to compare the effects of metoprolol and carvedilol in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) study.......This study sought to compare the effects of metoprolol and carvedilol in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) study....

  5. Long-term outcomes and cost effectiveness of high-dose dexamethasone for cardiac surgery : A randomised trial

    NARCIS (Netherlands)

    Dieleman, J. M.; de Wit, G. A.; Nierich, A. P.; Rosseel, P. M.; van der Maaten, J. M.; Hofland, J.; Diephuis, J. C.; de Lange, F.; Boer, C.; Neslo, R. E.; Moons, K. G.; van Herwerden, L. A.; Tijssen, J. G.; Kalkman, C. J.; van Dijk, D.

    Prophylactic intra-operative administration of dexamethasone may improve short-term clinical outcomes in cardiac surgical patients. The purpose of this study was to evaluate long-term clinical outcomes and cost effectiveness of dexamethasone versus placebo. Patients included in the multicentre,

  6. Long-term outcomes and cost effectiveness of high-dose dexamethasone for cardiac surgery: a randomised trial

    NARCIS (Netherlands)

    Dieleman, J. M.; de Wit, G. A.; Nierich, A. P.; Rosseel, P. M.; van der Maaten, J. M.; Hofland, J.; Diephuis, J. C.; de Lange, F.; Boer, C.; Neslo, R. E.; Moons, K. G.; van Herwerden, L. A.; Tijssen, J. G.; Kalkman, C. J.; van Dijk, D.

    2017-01-01

    Prophylactic intra-operative administration of dexamethasone may improve short-term clinical outcomes in cardiac surgical patients. The purpose of this study was to evaluate long-term clinical outcomes and cost effectiveness of dexamethasone versus placebo. Patients included in the multicentre,

  7. Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods part 1: rationale and methodology for the impedance threshold device (ITD) protocol.

    Science.gov (United States)

    Aufderheide, Tom P; Kudenchuk, Peter J; Hedges, Jerris R; Nichol, Graham; Kerber, Richard E; Dorian, Paul; Davis, Daniel P; Idris, Ahamed H; Callaway, Clifton W; Emerson, Scott; Stiell, Ian G; Terndrup, Thomas E

    2008-08-01

    The primary aim of this study is to compare survival to hospital discharge with a modified Rankin score (MRS)CPR) plus an active impedance threshold device (ITD) versus standard CPR plus a sham ITD in patients with out-of-hospital cardiac arrest. Secondary aims are to compare functional status and depression at discharge and at 3 and 6 months post-discharge in survivors. Prospective, double-blind, randomized, controlled, clinical trial. Patients with non-traumatic out-of-hospital cardiac arrest treated by emergency medical services (EMS) providers. EMS systems participating in the Resuscitation Outcomes Consortium. Based on a one-sided significance level of 0.025, power=0.90, a survival with MRSCPR and sham ITD, and two interim analyses, a maximum of 14,742 evaluable patients are needed to detect a 6.69% survival with MRSCPR and active ITD (1.36% absolute survival difference). If the ITD demonstrates the hypothesized improvement in survival, it is estimated that 2700 deaths from cardiac arrest per year would be averted in North America alone.

  8. Interaction of Left Ventricular Size and Sex on Outcome of Cardiac Resynchronization Therapy Among Patients With a Narrow QRS Duration in the EchoCRT Trial

    DEFF Research Database (Denmark)

    Varma, Niraj; Sogaard, Peter; Bax, Jeroen J

    2018-01-01

    BACKGROUND: Longer QRS duration (QRSd) improves, but increased left ventricular (LV) end-diastolic volume (LVEDV) reduces, efficacy of cardiac resynchronization therapy (CRT). QRSd/LVEDV ratios differ between sexes. We hypothesized that in the EchoCRT (Echocardiography Guided Cardiac Resynchroniz......BACKGROUND: Longer QRS duration (QRSd) improves, but increased left ventricular (LV) end-diastolic volume (LVEDV) reduces, efficacy of cardiac resynchronization therapy (CRT). QRSd/LVEDV ratios differ between sexes. We hypothesized that in the EchoCRT (Echocardiography Guided Cardiac...... Resynchronization Therapy) trial enrolling patients with heart failure with QRSd New York Heart Association class III, QRSd

  9. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA)

    DEFF Research Database (Denmark)

    Poulter, Neil R; Wedel, Hans; Dahlöf, Björn

    2005-01-01

    Results of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA) show significantly lower rates of coronary and stroke events in individuals allocated an amlodipine-based combination drug regimen than in those allocated an atenolol-based combination drug regimen (HR...

  10. The addition of voice prompts to audiovisual feedback and debriefing does not modify CPR quality or outcomes in out of hospital cardiac arrest--a prospective, randomized trial.

    Science.gov (United States)

    Bohn, Andreas; Weber, Thomas P; Wecker, Sascha; Harding, Ulf; Osada, Nani; Van Aken, Hugo; Lukas, Roman P

    2011-03-01

    Chest compression quality is a determinant of survival from out-of-hospital cardiac arrest (OHCA). ERC 2005 guidelines recommend the use of technical devices to support rescuers giving compressions. This prospective randomized study reviewed influence of different feedback configurations on survival and compression quality. 312 patients suffering an OHCA were randomly allocated to two different feedback configurations. In the limited feedback group a metronome and visual feedback was used. In the extended feedback group voice prompts were added. A training program was completed prior to implementation, performance debriefing was conducted throughout the study. Survival did not differ between the extended and limited feedback groups (47.8% vs 43.9%, p = 0.49). Average compression depth (mean ± SD: 4.74 ± 0.86 cm vs 4.84 ± 0.93 cm, p = 0.31) was similar in both groups. There were no differences in compression rate (103 ± 7 vs 102 ± 5 min(-1), p=0.74) or hands-off fraction (16.16% ± 0.07 to 17.04% ± 0.07, p = 0.38). Bystander CPR, public arrest location, presenting rhythm and chest compression depth were predictors of short term survival (ROSC to ED). Even limited CPR-feedback combined with training and ongoing debriefing leads to high chest compression quality. Bystander CPR, location, rhythm and chest compression depth are determinants of survival from out of hospital cardiac arrest. Addition of voice prompts does neither modify CPR quality nor outcome in OHCA. CC depth significantly influences survival and therefore more focus should be put on correct delivery. Further studies are needed to examine the best configuration of feedback to improve CPR quality and survival. ClinicalTrials.gov (NCT00449969), http://www.clinicalTrials.gov. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  11. Impact of baseline PR interval on cardiac resynchronization therapy outcomes in patients with narrow QRS complexes: an analysis of the ReThinQ Trial.

    Science.gov (United States)

    Joshi, Nikhil P; Stopper, Matthew M; Li, Jianqing; Beshai, John F; Pavri, Behzad B

    2015-08-01

    Heart failure (HF) is a major cause of morbidity and mortality, and ventricular dyssynchrony is an important contributor. The ReThinQ trial reported no improvement with cardiac resynchronization therapy (CRT) in HF patients with left ventricular ejection fraction (LVEF) PR interval. We retrospectivelyanalyzed the 87 patients from ReThinQ who were randomized to CRT. Patients were divided into two groups: baseline PR interval PR interval ≥180 ms. The primary outcome was change in VO2 max at 6 months; secondary outcomes were change in LVEF, 6-min walk distance, and change in NYHA class. Forty-six patients had PR PR ≥ 180 ms. The baseline characteristics were similar in the two groups. As compared to patients with a short PR interval, at 6 months, only patients with PR ≥ 180 ms showed a statistically significant increase in VO2 max from 12.2 to 13.6 mL/kg min (P = 0.045). Similarly, LVEF was significantly improved only in the long PR group (0.26 to 0.28, P = 0.038). A greater percentage of patients in the long PR group showed improvement by at least one NYHA class (59 vs. 35%, P = 0.033). A longer baseline PR interval may allow more efficacious delivery of CRT by allowing programming of physiologic AV delays. A short baseline PR interval may contribute to LV under-filling and CRT non-response.

  12. The Clinical Presentation, Survival Outcomes, and Management of Patients With Renal Cell Carcinoma and Cardiac Metastasis Without Inferior Vena Cava Involvement: Results From a Pooled Clinical Trial Database and Systematic Review of Reported Cases.

    Science.gov (United States)

    Viteri Malone, Mariuxi A; Ares, Gustavo Ruiz; De Velasco, Guillermo; Brandão, Raphael; Lin, Xun; Norton, Craig; Simantov, Ronit; Moslehi, Javid; Krajewski, Katherine M; Choueiri, Toni K; McKay, Rana R

    2018-04-01

    Cardiac metastases from renal cell carcinoma (RCC) are uncommon and there are limited data regarding the presentation and outcomes of this population. The objective of this study was to evaluate the characteristics and outcomes of patients with RCC with cardiac metastasis without inferior vena cava (IVC) involvement. We conducted a pooled retrospective analysis of metastatic RCC patients treated in 4 clinical trials. Additionally, we conducted a systematic review of cases reported in the literature from 1973 to 2015. Patients with cardiac metastases from RCC without IVC involvement were included. Patient and disease characteristics were described. Additionally, treatments, response to therapy, and survival outcomes were summarized. Of 1765 metastatic RCC patients in the clinical trials database, 10 had cardiac metastases without IVC involvement. All patients received treatment with targeted therapy. There was 1 observed partial response (10%) and 6 patients showed stable disease (60%). The median progression-free survival was 6.9 months. The systematic review of reported clinical cases included 39 patients. In these patients, the most common cardiac site of involvement was the right ventricle (51%; n = 20). Patients were treated with medical (28%; n = 11) and/or surgical treatment (49%; n = 19) depending on whether disease was isolated (n = 13) or multifocal (n = 26). To our knowledge, this is the first series to report on the presentation and outcomes of patients with cardiac metastasis without IVC involvement in RCC. We highlight that although the frequency of patients with cardiac metastases without IVC involvement is low, these patients have a unique clinical presentation and warrant special multidisciplinary management. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Serum tau and neurological outcome in cardiac arrest

    DEFF Research Database (Denmark)

    Mattsson, Niklas; Zetterberg, Henrik; Nielsen, Niklas

    2017-01-01

    OBJECTIVE: To test serum tau as a predictor of neurological outcome after cardiac arrest. METHODS: We measured the neuronal protein tau in serum at 24, 48, and 72 hours after cardiac arrest in 689 patients in the prospective international Target Temperature Management trial. The main outcome...... was poor neurological outcome, defined as Cerebral Performance Categories 3-5 at 6 months. RESULTS: Increased tau was associated with poor outcome at 6 months after cardiac arrest (median = 38.5, interquartile range [IQR] = 5.7-245ng/l in poor vs median = 1.5, IQR = 0.7-2.4ng/l in good outcome, for tau....... The accuracy in predicting outcome by serum tau was equally high for patients randomized to 33 °C and 36 °C targeted temperature after cardiac arrest. INTERPRETATION: Serum tau is a promising novel biomarker for prediction of neurological outcome in patients with cardiac arrest. It may be significantly better...

  14. Role of blood pressure and other variables in the differential cardiovascular event rates noted in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA)

    DEFF Research Database (Denmark)

    Poulter, Neil R; Wedel, Hans; Dahlöf, Björn

    2005-01-01

    Results of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA) show significantly lower rates of coronary and stroke events in individuals allocated an amlodipine-based combination drug regimen than in those allocated an atenolol-based combination drug regimen (HR...... 0.86 and 0.77, respectively). Our aim was to assess to what extent these differences were due to significant differences in blood pressures and in other variables noted after randomisation....

  15. Surface electrocardiogram to predict outcome in candidates for cardiac resynchronization therapy: a sub-analysis of the CARE-HF trial

    DEFF Research Database (Denmark)

    Gervais, Renaud; Leclercq, Christophe; Shankar, Aparna

    2009-01-01

    AIMS: In CARE-HF, cardiac resynchronization therapy (CRT) lowered morbidity and mortality in patients with moderate to severe heart failure. We examined whether baseline and follow-up electrocardiographic characteristics might predict long-term outcome. METHODS AND RESULTS: CARE-HF randomly assig...

  16. Reduction in cardiac mortality with bivalirudin in patients with and without major bleeding: The HORIZONS-AMI trial (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction).

    Science.gov (United States)

    Stone, Gregg W; Clayton, Tim; Deliargyris, Efthymios N; Prats, Jayne; Mehran, Roxana; Pocock, Stuart J

    The purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH+GPI) can be fully attributed to reduced bleeding. The association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin. A total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH+GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding. When compared with UFH+GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs. 10.5%, hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.51 to 0.80], p accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR: 0.57 [95% CI: 0.39 to 0.83], p = 0.003). Bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  17. Single versus Serial Measurements of Neuron-Specific Enolase and Prediction of Poor Neurological Outcome in Persistently Unconscious Patients after Out-Of-Hospital Cardiac Arrest - A TTM-Trial Substudy

    DEFF Research Database (Denmark)

    Wiberg, Sebastian; Hassager, Christian; Stammet, Pascal

    2017-01-01

    were included from sites participating in the TTM-trial biobank sub study. NSE was measured at 24, 48 and 72 hours after ROSC and follow-up was concluded after 180 days. The primary end point was poor neurological function or death defined by a cerebral performance category score (CPC-score) of 3 to 5...... of the biomarker neuron-specific enolase (NSE) in combination with other predictors of outcome in patients admitted after out-of-hospital cardiac arrest (OHCA). This study sought to investigate the ability of NSE to predict poor outcome in patients remaining unconscious at day three after OHCA. In addition....... RESULTS: A total of 685 (73%) patients participated in the study. At day three after OHCA 63 (9%) patients had died and 473 (69%) patients were not awake. In these patients, a single NSE measurement at 48 hours predicted poor outcome with an area under the receiver operating characteristics curve (AUC...

  18. The role of a behavioural medicine intervention in physiotherapy for the effects of rehabilitation outcomes in exercise-based cardiac rehabilitation (ECRA) - the study protocol of a randomised, controlled trial.

    Science.gov (United States)

    Borg, Sabina; Öberg, Birgitta; Nilsson, Lennart; Söderlund, Anne; Bäck, Maria

    2017-05-25

    To help patients with coronary artery disease (CAD) benefit from the positive health effects attained by exercise-based cardiac rehabilitation (CR), adherence to these programmes according to international guidelines is important. Strategies to increase adherence to exercise-based CR are mainly an unexplored area. The objective of this study is to investigate the effects of a behavioural medicine intervention in physiotherapy, containing goal-setting, self-monitoring and feedback, with the aim of improving rehabilitation outcomes for exercise-based CR, compared with usual care. This is a randomised, controlled trial. A total of 160 patients with CAD will be included consecutively at the Coronary Care Unit at a university hospital in Sweden. Patients are randomised 1:1 using sealed envelopes to usual care or a behavioural medicine intervention in physiotherapy, in addition to usual care for 4 months. Outcome assessment at baseline, 4 and 12 months includes submaximal aerobic capacity (primary outcome), exercise adherence, muscle endurance, level of physical activity, biomarkers, anxiety and depression, health-related quality of life, patient enablement and self-efficacy (secondary outcomes). This is the first study to evaluate the role of an integrated behavioural medicine intervention in exercise-based CR in the effects of rehabilitation outcomes. The results of this study will provide valuable information about the effect of these interventions in exercise-based CR and it has the potential to inform and assist in further treatment in secondary prevention for patients with CAD. The study include all items from the World Health Organization Trial Registration Data Set. NCT02895451, 2016-08-16, retrospectively registered.

  19. Rapid-rate nonsustained ventricular tachycardia found on implantable cardioverter-defibrillator interrogation: relationship to outcomes in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial).

    Science.gov (United States)

    Chen, Jay; Johnson, George; Hellkamp, Anne S; Anderson, Jill; Mark, Daniel B; Lee, Kerry L; Bardy, Gust H; Poole, Jeanne E

    2013-05-28

    The aim of this study was to examine rapid-rate nonsustained ventricular tachycardia (RR-NSVT) during routine implantable cardioverter-defibrillator (ICD) evaluation in patients with heart failure and its relationship to outcomes. The clinical implications of RR-NSVT identified during routine ICD interrogation are unclear. In this study, the occurrence of RR-NSVT and its association with ICD shocks and mortality in SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) were examined. The 811 patients who received ICDs in SCD-HeFT constituted the study population. The occurrence of RR-NSVT and its association with ICD shocks and mortality in SCD-HeFT were examined. RR-NSVT was documented on ICD interrogation in 186 of 811 patients (22.9%). The mean duration of RR-NSVT was 26.4 ± 9.1 beats (7.5 ± 2.6 s), with a mean cycle length of 259 ± 32 ms. Polymorphic RR-NSVT accounted for 56% of episodes. Compared with patients without RR-NSVT, those with RR-NSVT were less likely to be taking beta-blockers, statins, or aspirin at enrollment. After adjusting for other known predictors of mortality in SCD-HeFT, RR-NSVT was independently associated with appropriate ICD shocks (hazard ratio: 4.25; 95% confidence interval: 2.94 to 6.14; p interrogation should be considered an important clinical event. RR-NSVT during ICD interrogation is associated with appropriate ICD shocks and all-cause mortality. The clinical evaluation of patients with RR-NSVT should include intensification of medical therapy, particularly beta-blockers, or other appropriate clinical interventions. (Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]; NCT00000609). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  20. Clinical Trials in Cardiac Arrest and Subarachnoid Hemorrhage: Lessons from the Past and Ideas for the Future

    Directory of Open Access Journals (Sweden)

    Jennifer A. Frontera

    2013-01-01

    Full Text Available Introduction. Elevated intracranial pressure that occurs at the time of cerebral aneurysm rupture can lead to inadequate cerebral blood flow, which may mimic the brain injury cascade that occurs after cardiac arrest. Insights from clinical trials in cardiac arrest may provide direction for future early brain injury research after subarachnoid hemorrhage (SAH. Methods. A search of PubMed from 1980 to 2012 and clinicaltrials.gov was conducted to identify published and ongoing randomized clinical trials in aneurysmal SAH and cardiac arrest patients. Only English, adult, human studies with primary or secondary mortality or neurological outcomes were included. Results. A total of 142 trials (82 SAH, 60 cardiac arrest met the review criteria (103 published, 39 ongoing. The majority of both published and ongoing SAH trials focus on delayed secondary insults after SAH (70%, while 100% of cardiac arrest trials tested interventions within the first few hours of ictus. No SAH trials addressing treatment of early brain injury were identified. Twenty-nine percent of SAH and 13% of cardiac arrest trials showed outcome benefit, though there is no overlap mechanistically. Conclusions. Clinical trials in SAH assessing acute brain injury are warranted and successful interventions identified by the cardiac arrest literature may be reasonable targets of the study.

  1. Cardiac surgery with cardiopulmonary bypass: does aprotinin affect outcome?

    NARCIS (Netherlands)

    van der Linden, P. J.; Hardy, J.-F.; Daper, A.; Trenchant, A.; de Hert, S. G.

    2007-01-01

    BACKGROUND: Aprotinin, a non-specific serine protease inhibitor, has been used for two decades to reduce perioperative blood loss and the risk for allogeneic transfusion in cardiac surgery. This study evaluated the effects of aprotinin on outcome (mortality, cardiac events, renal failure, and

  2. Cardiac complications in diphtheria and predictors of outcomes.

    Science.gov (United States)

    Samdani, Sunil; Jain, Avani; Meena, Vinod; Meena, C B

    2018-01-01

    To study the cardiac complications in diphtheria patients and to study the predictors of outcomes. Single centre prospective analysis of cardiac complications in diphtheria patients. In this study, there were 60 patients diagnosed with diphtheria with ECG changes. The ECG changes seen were sinus tachycardia (68.3%), T wave inversion (20%), ST segment depression (13.3%), right bundle branch block (5%), multiple atrial ectopics (3.3%). The case fatality rate in our study was 25% (15 patients). High CPK-MB, myoglobulin and cardiac troponin levels were associated with cardiac mortality. In our study, cardiac troponin T had the highest sensitivity (80%) and CK-MB had the highest specificity (95.56%). Cardiac involvement is a common complication of infection with C. diphtheria and is associated with high mortality. As diphtheria can be prevented by adequate vaccination, efforts should be maximized for high vaccine coverage with booster doses. Copyright © 2017. Published by Elsevier B.V.

  3. Epidemiology and Outcomes After In-Hospital Cardiac Arrest After Pediatric Cardiac Surgery

    Science.gov (United States)

    Gupta, Punkaj; Jacobs, Jeffrey P.; Pasquali, Sara K.; Hill, Kevin D.; Gaynor, J. William; O’Brien, Sean M.; He, Max; Sheng, Shubin; Schexnayder, Stephen M.; Berg, Robert A.; Nadkarni, Vinay M.; Imamura, Michiaki; Jacobs, Marshall L.

    2014-01-01

    Background Multicenter data regarding cardiac arrest in children undergoing heart operations are limited. We describe epidemiology and outcomes associated with postoperative cardiac arrest in a large multiinstitutional cohort. Methods Patients younger than 18 years in the Society of Thoracic Surgeons Congenital Heart Surgery Database (2007 through 2012) were included. Patient factors, operative characteristics, and outcomes were described for patients with and without postoperative cardiac arrest. Multivariable models were used to evaluate the association of center volume with cardiac arrest rate and mortality after cardiac arrest, adjusting for patient and procedural factors. Results Of 70,270 patients (97 centers), 1,843 (2.6%) had postoperative cardiac arrest. Younger age, lower weight, and presence of preoperative morbidities (all p < 0.0001) were associated with cardiac arrest. Arrest rate increased with procedural complexity across common benchmark operations, ranging from 0.7% (ventricular septal defect repair) to 12.7% (Norwood operation). Cardiac arrest was associated with significant mortality risk across procedures, ranging from 15.4% to 62.3% (all p < 0.0001). In multivariable analysis, arrest rate was not associated with center volume (odds ratio, 1.06; 95% confidence interval, 0.71 to 1.57 in low- versus high-volume centers). However, mortality after cardiac arrest was higher in low-volume centers (odds ratio, 2.00; 95% confidence interval, 1.52 to 2.63). This association was present for both high- and low-complexity operations. Conclusions Cardiac arrest carries a significant mortality risk across the stratum of procedural complexity. Although arrest rates are not associated with center volume, lower-volume centers have increased mortality after cardiac arrest. Further study of mechanisms to prevent cardiac arrest and to reduce mortality in those with an arrest is warranted. PMID:25443018

  4. Does Age Influence Cardiac Resynchronization Therapy Use and Outcome?

    Science.gov (United States)

    Heidenreich, Paul A; Tsai, Vivian; Bao, Haikun; Curtis, Jeptha; Goldstein, Mary; Curtis, Lesley; Hernandez, Adrian; Peterson, Pamela; Turakhia, Mintu P; Masoudi, Frederick A

    2015-06-01

    This study sought to describe the use of CRT-D and its association with survival for older patients. Many patients who receive cardiac resynchronization therapy with defibrillator (CRT-D) in practice are older than those included in clinical trials. We identified patients undergoing ICD implantation in the National Cardiovascular Disease Registry (NCDR) ICD registry from 2006 to 2009, who also met clinical trial criteria for CRT, including left ventricular ejection fraction (LVEF) ≤35%, QRS ≥120 ms, and New York Heart Association (NYHA) functional class III or IV. NCDR registry data were linked to the social security death index to determine the primary outcome of time to death from any cause. We identified 70,854 patients from 1,187 facilities who met prior trial criteria for CRT-D. The mean age of the 58,147 patients receiving CRT-D was 69.4 years with 6.4% of patients age 85 or older. CRT use was 80% or higher among candidates in all age groups. Follow-up was available for 42,285 patients age ≥65 years at 12 months. Receipt of CRT-D was associated with better survival at 1 year (82.1% vs. 77.1%, respectively) and 4 years (54.0% vs. 46.2% , respectively) than in those receiving only an ICD (p different for different age groups (p = 0.86 for interaction). More than 80% of older patients undergoing ICD implantation who were candidates for a CRT-D received the combined device. Mortality in older patients undergoing ICD implantation was high but was lower for those receiving CRT-D. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. The Influence of Cardiac Risk Factor Burden on Cardiac Stress Test Outcomes.

    Science.gov (United States)

    Schrock, Jon W; Li, Morgan; Orazulike, Chidubem; Emerman, Charles L

    2011-06-01

    Chest pain is the most common admission diagnosis for observation unit patients. These patients often undergo cardiac stress testing to further risk stratify for coronary artery disease (CAD). The decision of whom to stress is currently based on clinical judgment. We sought to determine the influence of cardiac risk factor burden on cardiac stress test outcome for patients tested from an observation unit, inpatient or outpatient setting. We performed a retrospective observational cohort study for all patients undergoing stress testing in our institution from June 2006 through July 2007. Cardiac risk factors were collected at the time of stress testing. Risk factors were evaluated in a summative fashion using multivariate regression adjusting for age and known coronary artery disease. The model was tested for goodness of fit and collinearity and the c statistic was calculated using the receiver operating curve. A total of 4026 subjects were included for analysis of which 22% had known CAD. The rates of positive outcome were 89 (12.0%), 95 (12.6%), and 343 (16.9%) for the OU, outpatients, and hospitalized patients respectively. While the odds of a positive test outcome increased for additional cardiac risk factors, ROC curve analysis indicates that simply adding the number of risk factors does not add significant diagnostic value. Hospitalized patients were more likely to have a positive stress test, OR 1.41 (1.10 - 1.81). Our study does not support basing the decision to perform a stress test on the number of cardiac risk factors.

  6. Cardiac asthma in elderly patients: incidence, clinical presentation and outcome

    Directory of Open Access Journals (Sweden)

    Ray Patrick

    2007-05-01

    Full Text Available Abstract Background Cardiac asthma is common, but has been poorly investigated. The objective was to compare the characteristics and outcome of cardiac asthma with that of classical congestive heart failure (CHF in elderly patients. Methods Prospective study in an 1,800-bed teaching hospital. Results Two hundred and twelve consecutive patients aged ≥ 65 years presenting with dyspnea due to CHF (mean age of 82 ± 8 years were included. Findings of cardiac echocardiography and natriuretic peptides levels were used to confirm CHF. Cardiac asthma patients were defined as a patient with CHF and wheezing reported by attending physician upon admission to the emergency department. The CHF group (n = 137 and the cardiac asthma group (n = 75, differed for tobacco use (34% vs. 59%, p 2 (47 ± 15 vs. 41 ± 11 mmHg, p Conclusion Patients with cardiac asthma represented one third of CHF in elderly patients. They were more hypercapnic and experienced more distal airway obstruction. However, outcomes were similar.

  7. Cardiac dysfunction in the trastuzumab clinical trials experience.

    Science.gov (United States)

    Seidman, Andrew; Hudis, Clifford; Pierri, Mary Kathryn; Shak, Steven; Paton, Virginia; Ashby, Mark; Murphy, Maureen; Stewart, Stanford J; Keefe, Deborah

    2002-03-01

    This study sought to estimate cardiac dysfunction (CD) risk for patients receiving trastuzumab; to characterize observed CD by severity, treatment, and clinical outcome; to assess effects of baseline clinical risk factors on CD; and to assess effects of cumulative doses of anthracyclines and trastuzumab on CD. A retrospective review of records for patients enrolled onto any of seven phase II and III trastuzumab clinical trials was performed. Predefined criteria were used for the diagnosis, and the New York Heart Association functional classification system was used to document CD severity. Product-limit estimates were used to summarize the cumulative anthracycline and trastuzumab doses at the time of CD onset. Patients treated with trastuzumab were found to be at an increased risk for CD. The incidence was greatest in patients receiving concomitant trastuzumab and anthracycline plus cyclophosphamide (27%). The risk was substantially lower in patients receiving paclitaxel and trastuzumab (13%) or trastuzumab alone (3% to 7%); however, most of these patients had received prior anthracycline therapy. CD was noted in 8% of patients receiving anthracycline plus cyclophosphamide and 1% receiving paclitaxel alone. Most trastuzumab-treated patients developing CD were symptomatic (75%), and most improved with standard treatment for congestive heart failure (79%). Trastuzumab is associated with an increased risk of CD, which is greatest in patients receiving concurrent anthracyclines. In most patients with metastatic breast cancer, the risk of CD can be justified given the improvement in overall survival previously reported with trastuzumab.

  8. Modern Radiation Therapy and Cardiac Outcomes in Breast Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Boero, Isabel J.; Paravati, Anthony J.; Triplett, Daniel P.; Hwang, Lindsay; Matsuno, Rayna K.; Gillespie, Erin F.; Yashar, Catheryn M.; Moiseenko, Vitali; Einck, John P.; Mell, Loren K. [Department of Radiation Medicine and Applied Sciences, Moores Cancer Center, University of California, San Diego, La Jolla, California (United States); Parikh, Sahil A. [University Hospitals Case Medical Center, Harrington Heart and Vascular Institute, and Case Western Reserve University School of Medicine, Cleveland, Ohio (United States); Murphy, James D., E-mail: j2murphy@ucsd.edu [Department of Radiation Medicine and Applied Sciences, Moores Cancer Center, University of California, San Diego, La Jolla, California (United States)

    2016-03-15

    Purpose: Adjuvant radiation therapy, which has proven benefit against breast cancer, has historically been associated with an increased incidence of ischemic heart disease. Modern techniques have reduced this risk, but a detailed evaluation has not recently been conducted. The present study evaluated the effect of current radiation practices on ischemia-related cardiac events and procedures in a population-based study of older women with nonmetastatic breast cancer. Methods and Materials: A total of 29,102 patients diagnosed from 2000 to 2009 were identified from the Surveillance, Epidemiology, and End Results–Medicare database. Medicare claims were used to identify the radiation therapy and cardiac outcomes. Competing risk models were used to assess the effect of radiation on these outcomes. Results: Patients with left-sided breast cancer had a small increase in their risk of percutaneous coronary intervention (PCI) after radiation therapy—the 10-year cumulative incidence for these patients was 5.5% (95% confidence interval [CI] 4.9%-6.2%) and 4.5% (95% CI 4.0%-5.0%) for right-sided patients. This risk was limited to women with previous cardiac disease. For patients who underwent PCI, those with left-sided breast cancer had a significantly increased risk of cardiac mortality with a subdistribution hazard ratio of 2.02 (95% CI 1.23-3.34). No other outcome, including cardiac mortality for the entire cohort, showed a significant relationship with tumor laterality. Conclusions: For women with a history of cardiac disease, those with left-sided breast cancer who underwent radiation therapy had increased rates of PCI and a survival decrement if treated with PCI. The results of the present study could help cardiologists and radiation oncologists better stratify patients who need more aggressive cardioprotective techniques.

  9. Modern Radiation Therapy and Cardiac Outcomes in Breast Cancer

    International Nuclear Information System (INIS)

    Boero, Isabel J.; Paravati, Anthony J.; Triplett, Daniel P.; Hwang, Lindsay; Matsuno, Rayna K.; Gillespie, Erin F.; Yashar, Catheryn M.; Moiseenko, Vitali; Einck, John P.; Mell, Loren K.; Parikh, Sahil A.; Murphy, James D.

    2016-01-01

    Purpose: Adjuvant radiation therapy, which has proven benefit against breast cancer, has historically been associated with an increased incidence of ischemic heart disease. Modern techniques have reduced this risk, but a detailed evaluation has not recently been conducted. The present study evaluated the effect of current radiation practices on ischemia-related cardiac events and procedures in a population-based study of older women with nonmetastatic breast cancer. Methods and Materials: A total of 29,102 patients diagnosed from 2000 to 2009 were identified from the Surveillance, Epidemiology, and End Results–Medicare database. Medicare claims were used to identify the radiation therapy and cardiac outcomes. Competing risk models were used to assess the effect of radiation on these outcomes. Results: Patients with left-sided breast cancer had a small increase in their risk of percutaneous coronary intervention (PCI) after radiation therapy—the 10-year cumulative incidence for these patients was 5.5% (95% confidence interval [CI] 4.9%-6.2%) and 4.5% (95% CI 4.0%-5.0%) for right-sided patients. This risk was limited to women with previous cardiac disease. For patients who underwent PCI, those with left-sided breast cancer had a significantly increased risk of cardiac mortality with a subdistribution hazard ratio of 2.02 (95% CI 1.23-3.34). No other outcome, including cardiac mortality for the entire cohort, showed a significant relationship with tumor laterality. Conclusions: For women with a history of cardiac disease, those with left-sided breast cancer who underwent radiation therapy had increased rates of PCI and a survival decrement if treated with PCI. The results of the present study could help cardiologists and radiation oncologists better stratify patients who need more aggressive cardioprotective techniques.

  10. A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design.

    Science.gov (United States)

    Zangrillo, Alberto; Alvaro, Gabriele; Pisano, Antonio; Guarracino, Fabio; Lobreglio, Rosetta; Bradic, Nikola; Lembo, Rosalba; Gianni, Stefano; Calabrò, Maria Grazia; Likhvantsev, Valery; Grigoryev, Evgeny; Buscaglia, Giuseppe; Pala, Giovanni; Auci, Elisabetta; Amantea, Bruno; Monaco, Fabrizio; De Vuono, Giovanni; Corcione, Antonio; Galdieri, Nicola; Cariello, Claudia; Bove, Tiziana; Fominskiy, Evgeny; Auriemma, Stefano; Baiocchi, Massimo; Bianchi, Alessandro; Frontini, Mario; Paternoster, Gianluca; Sangalli, Fabio; Wang, Chew-Yin; Zucchetti, Maria Chiara; Biondi-Zoccai, Giuseppe; Gemma, Marco; Lipinski, Michael J; Lomivorotov, Vladimir V; Landoni, Giovanni

    2016-07-01

    Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes. Double-blind, placebo-controlled, multicenter randomized trial. Tertiary care hospitals. Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours. The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction. This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Age of transfused blood is not associated with increased postoperative adverse outcome after cardiac surgery.

    LENUS (Irish Health Repository)

    McKenny, M

    2011-05-01

    This study investigated the hypothesis that storage age of transfused red blood cells (RBCs) is associated with adverse outcome after cardiac surgery, and examined association between volume of RBC transfusions and outcome after cardiac surgery.

  12. Impact of Early Vasopressor Administration on Neurological Outcomes after Prolonged Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Hubble, Michael W; Tyson, Clark

    2017-06-01

    Introduction Vasopressors are associated with return of spontaneous circulation (ROSC), but no long-term benefit has been demonstrated in randomized trials. However, these trials did not control for the timing of vasopressor administration which may influence outcomes. Consequently, the objective of this study was to develop a model describing the likelihood of favorable neurological outcome (cerebral performance category [CPC] 1 or 2) as a function of the public safety answering point call receipt (PSAP)-to-pressor-interval (PPI) in prolonged out-of-hospital cardiac arrest. Hypothesis The likelihood of favorable neurological outcome declines with increasing PPI. This investigation was a retrospective study of cardiac arrest using linked data from the Cardiac Arrest Registry to Enhance Survival (CARES) database (Centers for Disease Control and Prevention [Atlanta, Georgia USA]; American Heart Association [Dallas, Texas USA]; and Emory University Department of Emergency Medicine [Atlanta, Georgia USA]) and the North Carolina (USA) Prehospital Medical Information System. Adult patients suffering a bystander-witnessed, non-traumatic cardiac arrest between January 2012 and June 2014 were included. Logistic regression was used to calculate the adjusted odds ratio (OR) of neurological outcome as a function of PPI, while controlling for patient age, gender, and race; endotracheal intubation (ETI); shockable rhythm; layperson cardiopulmonary resuscitation (CPR); and field hypothermia. Of the 2,100 patients meeting inclusion criteria, 913 (43.5%) experienced ROSC, 618 (29.4%) survived to hospital admission, 187 (8.9%) survived to hospital discharge, and 155 (7.4%) were discharged with favorable neurological outcomes (CPC 1 or 2). Favorable neurological outcome was less likely with increasing PPI (OR=0.90; PCPR, and ETI were not independent predictors of favorable neurological outcome. In this evaluation, time to vasopressor administration was significantly associated with

  13. Blunt traumatic cardiac rupture: therapeutic options and outcomes.

    Science.gov (United States)

    Nan, Yu-Yun; Lu, Ming-Shian; Liu, Kuo-Sheng; Huang, Yao-Kuang; Tsai, Feng-Chun; Chu, Jaw-Ji; Lin, Pyng Jing

    2009-09-01

    Cardiac rupture following blunt thoracic trauma is rarely encountered by clinicians, since it commonly causes death at the scene. With advances in traumatology, blunt cardiac rupture had been increasingly disclosed in various ways. This study reviews our experience of patients with suspected blunt traumatic cardiac rupture and proposes treatment protocols for the same. This is a 5-year retrospective study of trauma patients confirmed with blunt traumatic cardiac rupture admitted to a university-affiliated tertiary trauma referral centre. The following information was collected from the patients: age, sex, mechanism of injury, initial effective diagnostic tool used for diagnosing blunt cardiac rupture, location and size of the cardiac injury, associated injury and injury severity score (ISS), reversed trauma score (RTS), survival probability of trauma and injury severity scoring (TRISS), vital signs and biochemical lab data on arrival at the trauma centre, time elapsed from injury to diagnosis and surgery, surgical details, hospital course and final outcome. The study comprised 8 men and 3 women with a median age of 39 years (range: 24-73 years) and the median follow-up was 5.5 months (range: 1-35 months). The ISS, RTS, and TRISS scores of the patients were 32.18+/-5.7 (range: 25-43), 6.267+/-1.684 (range: 2.628-7.841), and 72.4+/-25.6% (range: 28.6-95.5%), respectively. Cardiac injuries were first detected using focused assessment with sonography for trauma (FAST) in 4 (36.3%) patients, using transthoracic echocardiography in 3 (27.3%) patients, chest CT in 1 (9%) patient, and intra-operatively in 3 (27.3%) patients. The sites of cardiac injury comprised the superior vena cava/right atrium junction (n=4), right atrial auricle (n=1), right ventricle (n=4), left ventricular contusion (n=1), and diffuse endomyocardial dissection over the right and left ventricles (n=1). Notably, 2 had pericardial lacerations presenting as a massive haemothorax, which initially masked

  14. Randomized controlled trial of internal and external targeted temperature management methods in post- cardiac arrest patients.

    Science.gov (United States)

    Look, Xinqi; Li, Huihua; Ng, Mingwei; Lim, Eric Tien Siang; Pothiawala, Sohil; Tan, Kenneth Boon Kiat; Sewa, Duu Wen; Shahidah, Nur; Pek, Pin Pin; Ong, Marcus Eng Hock

    2018-01-01

    Targeted temperature management post-cardiac arrest is currently implemented using various methods, broadly categorized as internal and external. This study aimed to evaluate survival-to-hospital discharge and neurological outcomes (Glasgow-Pittsburgh Score) of post-cardiac arrest patients undergoing internal cooling verses external cooling. A randomized controlled trial of post-resuscitation cardiac arrest patients was conducted from October 2008-September 2014. Patients were randomized to either internal or external cooling methods. Historical controls were selected matched by age and gender. Analysis using SPSS version 21.0 presented descriptive statistics and frequencies while univariate logistic regression was done using R 3.1.3. 23 patients were randomized to internal cooling and 22 patients to external cooling and 42 matched controls were selected. No significant difference was seen between internal and external cooling in terms of survival, neurological outcomes and complications. However in the internal cooling arm, there was lower risk of developing overcooling (p=0.01) and rebound hyperthermia (p=0.02). Compared to normothermia, internal cooling had higher survival (OR=3.36, 95% CI=(1.130, 10.412), and lower risk of developing cardiac arrhythmias (OR=0.18, 95% CI=(0.04, 0.63)). Subgroup analysis showed those with cardiac cause of arrest (OR=4.29, 95% CI=(1.26, 15.80)) and sustained ROSC (OR=5.50, 95% CI=(1.64, 20.39)) had better survival with internal cooling compared to normothermia. Cooling curves showed tighter temperature control for internal compared to external cooling. Internal cooling showed tighter temperature control compared to external cooling. Internal cooling can potentially provide better survival-to-hospital discharge outcomes and reduce cardiac arrhythmia complications in carefully selected patients as compared to normothermia. Copyright © 2017. Published by Elsevier Inc.

  15. Relationship between chest compression rates and outcomes from cardiac arrest.

    Science.gov (United States)

    Idris, Ahamed H; Guffey, Danielle; Aufderheide, Tom P; Brown, Siobhan; Morrison, Laurie J; Nichols, Patrick; Powell, Judy; Daya, Mohamud; Bigham, Blair L; Atkins, Dianne L; Berg, Robert; Davis, Dan; Stiell, Ian; Sopko, George; Nichol, Graham

    2012-06-19

    Guidelines for cardiopulmonary resuscitation recommend a chest compression rate of at least 100 compressions per minute. Animal and human studies have reported that blood flow is greatest with chest compression rates near 120/min, but few have reported rates used during out-of-hospital (OOH) cardiopulmonary resuscitation or the relationship between rate and outcome. The purpose of this study was to describe chest compression rates used by emergency medical services providers to resuscitate patients with OOH cardiac arrest and to determine the relationship between chest compression rate and outcome. Included were patients aged ≥ 20 years with OOH cardiac arrest treated by emergency medical services providers participating in the Resuscitation Outcomes Consortium. Data were abstracted from monitor-defibrillator recordings during cardiopulmonary resuscitation. Multiple logistic regression analysis assessed the association between chest compression rate and outcome. From December 2005 to May 2007, 3098 patients with OOH cardiac arrest were included in this study. Mean age was 67 ± 16 years, and 8.6% survived to hospital discharge. Mean compression rate was 112 ± 19/min. A curvilinear association between chest compression rate and return of spontaneous circulation was found in cubic spline models after multivariable adjustment (P=0.012). Return of spontaneous circulation rates peaked at a compression rate of ≈ 125/min and then declined. Chest compression rate was not significantly associated with survival to hospital discharge in multivariable categorical or cubic spline models. Chest compression rate was associated with return of spontaneous circulation but not with survival to hospital discharge in OOH cardiac arrest.

  16. Remote Ischemic Preconditioning and Outcomes of Cardiac Surgery.

    OpenAIRE

    Hausenloy, DJ; Candilio, L; Evans, R; Ariti, C; Jenkins, DP; Kolvekar, S; Knight, R; Kunst, G; Laing, C; Nicholas, J; Pepper, J; Robertson, S; Xenou, M; Clayton, T; Yellon, DM

    2015-01-01

    : Whether remote ischemic preconditioning (transient ischemia and reperfusion of the arm) can improve clinical outcomes in patients undergoing coronary-artery bypass graft (CABG) surgery is not known. We investigated this question in a randomized trial. : We conducted a multicenter, sham-controlled trial involving adults at increased surgical risk who were undergoing on-pump CABG (with or without valve surgery) with blood cardioplegia. After anesthesia induction and before surgical incision, ...

  17. Neurodevelopmental outcome after cardiac surgery utilizing cardiopulmonary bypass in children

    Directory of Open Access Journals (Sweden)

    Aymen N Naguib

    2015-01-01

    Full Text Available Introduction: Modulating the stress response and perioperative factors can have a paramount impact on the neurodevelopmental outcome of infants who undergo cardiac surgery utilizing cardiopulmonary bypass. Materials and Methods: In this single center prospective follow-up study, we evaluated the impact of three different anesthetic techniques on the neurodevelopmental outcomes of 19 children who previously underwent congenital cardiac surgery within their 1 st year of life. Cases were done from May 2011 to December 2013. Children were assessed using the Stanford-Binet Intelligence Scales (5 th edition. Multiple regression analysis was used to test different parental and perioperative factors that could significantly predict the different neurodevelopmental outcomes in the entire cohort of patients. Results: When comparing the three groups regarding the major cognitive scores, a high-dose fentanyl (HDF patients scored significantly higher than the low-dose fentanyl (LDF + dexmedetomidine (DEX (LDF + DEX group in the quantitative reasoning scores (106 ± 22 vs. 82 ± 15 P = 0.046. The bispectral index (BIS value at the end of surgery for the -LDF group was significantly higher than that in LDF + DEX group (P = 0.011. For the entire cohort, a strong correlation was seen between the standard verbal intelligence quotient (IQ score and the baseline adrenocorticotropic hormone level, the interleukin-6 level at the end of surgery and the BIS value at the end of the procedure with an R 2 value of 0.67 and P < 0.04. There was an inverse correlation between the cardiac Intensive Care Unit length of stay and the full-scale IQ score (R = 0.4675 and P 0.027. Conclusions: Patients in the HDF group demonstrated overall higher neurodevelopmental scores, although it did not reach statistical significance except in fluid reasoning scores. Our results may point to a possible correlation between blunting the stress response and improvement of the neurodevelopmental

  18. Development and Validation of a Model to Predict Absolute Vascular Risk Reduction by Moderate-Intensity Statin Therapy in Individual Patients With Type 2 Diabetes Mellitus: The Anglo Scandinavian Cardiac Outcomes Trial, Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, and Collaborative Atorvastatin Diabetes Study.

    Science.gov (United States)

    Kaasenbrood, Lotte; Poulter, Neil R; Sever, Peter S; Colhoun, Helen M; Livingstone, Shona J; Boekholdt, S Matthijs; Pressel, Sara L; Davis, Barry R; van der Graaf, Yolanda; Visseren, Frank L J

    2016-05-01

    In this study, we aimed to translate the average relative effect of statin therapy from trial data to the individual patient with type 2 diabetes mellitus by developing and validating a model to predict individualized absolute risk reductions (ARR) of cardiovascular events. Data of 2725 patients with type 2 diabetes mellitus from the Lipid Lowering Arm of the Anglo Scandinavian Cardiac Outcomes Trial (ASCOT-LLA) study (atorvastatin 10 mg versus placebo) were used for model derivation. The model was based on 8 clinical predictors including treatment allocation (statin/placebo). Ten-year individualized ARR on major cardiovascular events by statin therapy were calculated for each patient by subtracting the estimated on-treatment risk from the estimated off-treatment risk. Predicted 10-year ARR by statin therapy was 4% (median ARR, 3.2%; interquartile range, 2.5%-4.3%; 95% confidence interval for 3.2% ARR, -1.4% to 6.8%). Addition of treatment interactions did not improve model performance. Therefore, the wide distribution in ARR was a consequence of the underlying distribution in cardiovascular risk enrolled in these trials. External validation of the model was performed in data from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT; pravastatin 40 mg versus usual care) and Collaborative Atorvastatin Diabetes Study (CARDS; atorvastatin 10 mg versus placebo) of 3878 and 2838 patients with type 2 diabetes mellitus, respectively. Model calibration was adequate in both external data sets, discrimination was moderate (ALLHAT-LLT: c-statistics, 0.64 [95% confidence interval, 0.61-0.67] and CARDS: 0.68 [95% confidence interval, 0.64-0.72]). ARRs of major cardiovascular events by statin therapy can be accurately estimated for individual patients with type 2 diabetes mellitus using a model based on routinely available patient characteristics. There is a wide distribution in ARR that may complement informed decision making. URL: http

  19. Milrinone for cardiac dysfunction in critically ill adult patients: a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

    Science.gov (United States)

    Koster, Geert; Bekema, Hanneke J; Wetterslev, Jørn; Gluud, Christian; Keus, Frederik; van der Horst, Iwan C C

    2016-09-01

    Milrinone is an inotrope widely used for treatment of cardiac failure. Because previous meta-analyses had methodological flaws, we decided to conduct a systematic review of the effect of milrinone in critically ill adult patients with cardiac dysfunction. This systematic review was performed according to The Cochrane Handbook for Systematic Reviews of Interventions. Searches were conducted until November 2015. Patients with cardiac dysfunction were included. The primary outcome was serious adverse events (SAE) including mortality at maximum follow-up. The risk of bias was evaluated and trial sequential analyses were conducted. The quality of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation criteria. A total of 31 randomised clinical trials fulfilled the inclusion criteria, of which 16 provided data for our analyses. All trials were at high risk of bias, and none reported the primary composite outcome SAE. Fourteen trials with 1611 randomised patients reported mortality data at maximum follow-up (RR 0.96; 95% confidence interval 0.76-1.21). Milrinone did not significantly affect other patient-centred outcomes. All analyses displayed statistical and/or clinical heterogeneity of patients, interventions, comparators, outcomes, and/or settings and all featured missing data. The current evidence on the use of milrinone in critically ill adult patients with cardiac dysfunction suffers from considerable risks of both bias and random error and demonstrates no benefits. The use of milrinone for the treatment of critically ill patients with cardiac dysfunction can be neither recommended nor refuted. Future randomised clinical trials need to be sufficiently large and designed to have low risk of bias.

  20. The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

    2016-01-28

    Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

  1. Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery: An Update Meta-Analysis and Trial Sequential Analysis

    Directory of Open Access Journals (Sweden)

    Benji Wang

    2018-01-01

    Full Text Available Background. Recent studies suggest that levosimendan does not provide mortality benefit in patients with low cardiac output syndrome undergoing cardiac surgery. These results conflict with previous findings. The aim of the current study is to assess whether levosimendan reduces postoperative mortality in patients with impaired left ventricular function (mean EF ≤ 40% undergoing cardiac surgery. Methods. We conducted a comprehensive search of PubMed, EMBASE, and Cochrane Library Database through November 20, 2017. Inclusion criteria were random allocation to treatment with at least one group receiving levosimendan and another group receiving placebo or other treatments and cardiac surgery patients with a left ventricular ejection fraction of 40% or less. The primary endpoint was postoperative mortality. Secondary outcomes were cardiac index, pulmonary capillary wedge pressure (PCWP, length of intensive care unit (ICU stay, postoperative atrial fibrillation, and postoperative renal replacement therapy. We performed trial sequential analysis (TSA to evaluate the reliability of the primary endpoint. Results. Data from 2,152 patients in 15 randomized clinical trials were analyzed. Pooled results demonstrated a reduction in postoperative mortality in the levosimendan group [RR = 0.53, 95% CI (0.38–0.73, I2=0]. However, the result of TSA showed that the conclusion may be a false positive. Secondary outcomes demonstrated that PCWP, postoperative renal replacement therapy, and length of ICU stay were significantly reduced. Cardiac index was greater in the levosimendan group. No difference was found in the rate of postoperative atrial fibrillation. Conclusions. Levosimendan reduces the rate of death and other adverse outcomes in patients with low ejection fraction who were undergoing cardiac surgery, but results remain inconclusive. More large-volume randomized clinical trials (RCTs are warranted.

  2. Outcome of children with Pentalogy of Cantrell following cardiac surgery.

    LENUS (Irish Health Repository)

    O'Gorman, Clodagh S

    2012-02-01

    Although single individual reports have documented outcomes in children with pentalogy of are few data available for postoperative outcome of this cohort of patients after cardiac surgery. The aim of this study was to retrospectively review the clinical details of patients with pentalogy of Cantrell managed at two centers. Two cardiac surgical institutions retrospectively studied all patients with pentalogy of Cantrell and significant congenital heart disease who underwent surgical intervention, excluding PDA ligation, between 1992 and 2004. Seven children with pentalogy of Cantrell underwent surgical intervention at a median age of 60 days (range, 1-11 months). Three patients had tetralogy of Fallot, two double outlet right ventricle, one patient had tricuspid atresia, and one patient a perimembranous ventricular septal defect. The mean duration of postoperative ventilation was 112.8 days (range, 4-335 days) but three patients required ventilation for more than 100 days. Patients who had a preoperative diaphragmatic plication required a longer duration of ventilation (mean = 186.5 days [range, 100-273 days] compared with mean = 132 days [range, 4-335 days]). Four patients survived, with three patients weaned from ventilation. Three patients had withdrawal of care following failure to wean from ventilation, following multisystem organ failure, and at the request of their parents. In conclusion, the postoperative care of children with pentalogy of Cantrell after cardiac surgery is often complicated by prolonged need for ventilatory support and multiple postoperative complications. Earlier surgical intervention does not necessarily reduce morbidity and mortality. These data may help in the counseling of parents prior to surgical intervention.

  3. Impact of Medicaid Expansion on Cardiac Surgery Volume and Outcomes.

    Science.gov (United States)

    Charles, Eric J; Johnston, Lily E; Herbert, Morley A; Mehaffey, J Hunter; Yount, Kenan W; Likosky, Donald S; Theurer, Patricia F; Fonner, Clifford E; Rich, Jeffrey B; Speir, Alan M; Ailawadi, Gorav; Prager, Richard L; Kron, Irving L

    2017-10-01

    Thirty-one states approved Medicaid expansion after implementation of the Affordable Care Act. The objective of this study was to evaluate the effect of Medicaid expansion on cardiac surgery volume and outcomes comparing one state that expanded to one that did not. Data from the Virginia (nonexpansion state) Cardiac Services Quality Initiative and the Michigan (expanded Medicaid, April 2014) Society of Thoracic and Cardiovascular Surgeons Quality Collaborative were analyzed to identify uninsured and Medicaid patients undergoing coronary bypass graft or valve operations, or both. Demographics, operative details, predicted risk scores, and morbidity and mortality rates, stratified by state and compared across era (preexpansion: 18 months before vs postexpansion: 18 months after), were analyzed. In Virginia, there were no differences in volume between eras, whereas in Michigan, there was a significant increase in Medicaid volume (54.4% [558 of 1,026] vs 84.1% [954 of 1,135], p Medicaid patients, there were no differences in predicted risk of morbidity or mortality or postoperative major morbidities. In Michigan Medicaid patients, a significant decrease in predicted risk of morbidity or mortality (11.9% [8.1% to 20.0%] vs 11.1% [7.7% to 17.9%], p = 0.02) and morbidities (18.3% [102 of 558] vs 13.2% [126 of 954], p = 0.008) was identified. Postexpansion was associated with a decreased risk-adjusted rate of major morbidity (odds ratio, 0.69; 95% confidence interval, 0.51 to 0.91; p = 0.01) in Michigan Medicaid patients. Medicaid expansion was associated with fewer uninsured cardiac surgery patients and improved predicted risk scores and morbidity rates. In addition to improving health care financing, Medicaid expansion may positively affect patient care and outcomes. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  4. Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy (‘SMART’ Trial: a randomised trial

    Directory of Open Access Journals (Sweden)

    Md Ali Katijjahbe

    2018-04-01

    Full Text Available Question: In people who have undergone cardiac surgery via median sternotomy, does modifying usual sternal precautions to make them less restrictive improve physical function, pain, kinesiophobia and health-related quality of life? Design: Two-centre, randomised, controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. Participants: Seventy-two adults who had undergone cardiac surgery via a median sternotomy were included. Intervention: Participants were randomly allocated to one of two groups at 4 (SD 1 days after surgery. The control group received the usual advice to restrict their upper limb use for 4 to 6 weeks (ie, restrictive sternal precautions. The experimental group received advice to use pain and discomfort as the safe limits for their upper limb use during daily activities (ie, less restrictive precautions for the same period. Both groups received postoperative individualised education in hospital and via weekly telephone calls for 6 weeks. Outcome measures: The primary outcome was physical function assessed by the Short Physical Performance Battery. Secondary outcomes included upper limb function, pain, kinesophobia, and health-related quality of life. Outcomes were measured before hospital discharge and at 4 and 12 weeks postoperatively. Adherence to sternal precautions was recorded. Results: There were no statistically significant differences in physical function between the groups at 4 weeks (MD 1.0, 95% CI –0.2 to 2.3 and 12 weeks (MD 0.4, 95% CI –0.9 to 1.6 postoperatively. There were no statistically significant between-group differences in secondary outcomes. Conclusion: Modified (ie, less restrictive sternal precautions for people following cardiac surgery had similar effects on physical recovery, pain and health-related quality of life as usual restrictive sternal precautions. Similar outcomes can be anticipated regardless of whether people following cardiac surgery are managed with

  5. Outcome among patients suffering from in-hospital cardiac arrest

    Directory of Open Access Journals (Sweden)

    Trpković Sladjana

    2014-01-01

    Full Text Available Introduction. In relation to pre-hospital treatment of patients with cardiac arrest (CA in the field where resuscitation is often started by nonprofessionals, resuscitation in hospital is most commonly performed by well-trained personnel. Objective. The aim was to define the factors associated with an improved outcome among patients suffering from the inhospital CA (IHCA. Methods. The prospective study included a total of 100 patients in the Emergency Center over two-year period. The patterns by the Utstein-Style guidelines recorded the following: age, sex, reason for hospital admission, comorbidity, cause and origin of CA, continuous monitoring, time of arrival of the medical emergency team and time of delivery of the first defibrillation shock (DC. Results. Most patients (61% had cardiac etiology. Return of spontaneous circulation (ROSC was achieved in 58% of patients. ROSC was more frequently achieved in younger patients (57.69±11.37, (p<0.05, non-surgical patients (76.1%, (p<0.01 and in patients who were in continuous monitoring (66.7% (p<0.05. The outcome of CPR was significantly better in patients who received advanced life support (ALS (76.6% (p<0.01. Time until the delivery of the first DC shock was significantly shorter in patients who achieved ROSC (1.67±1.13 min, (p<0.01. A total of 5% of IHCA patients survived to hospital discharge. Conclusion. In our study, the outcome of CPR was better in patients who were younger and with non-surgical diseases, which are prognostic factors that we cannot control. Factors associated with better outcome of IHCA patients were: continuous monitoring, shorter time until the delivery of the first DC and ALS. This means that better education of medical staff, better organization and up-to-dated technical equipment are needed.

  6. Cardiac Surgery Outcomes in Patients With Chronic Lymphocytic Leukemia.

    Science.gov (United States)

    Zhu, Yuanjia; Toth, Andrew J; Lowry, Ashley M; Blackstone, Eugene H; Hill, Brian T; Mick, Stephanie L

    2018-04-01

    Surgical outcomes of patients with chronic lymphocytic leukemia (CLL) undergoing cardiac surgery are limited. Our objectives were to investigate hospital morbidity and mortality after open cardiac surgery in CLL versus non-CLL patients. From May 1995 to May 2015, 157 patients with CLL and 55,917 without and older than 47 years underwent elective cardiac surgery at Cleveland Clinic. By Rai criteria, 79 CLL patients (56%) were low risk (class 0), 13 (9.1%) intermediate risk (classes I and II), and 38 (27%) high risk (classes III and IV); 12 (8.5%) were in remission. Mean age of CLL patients was 72 ± 9.0 years, and 18% were women. CLL patients were propensity-score matched to 3 non-CLL patients to compare surgical outcomes. High-risk CLL patients received more blood products than matched non-CLL patients (33/38 [87%] versus 74/114 [65%], p = 0.01), but were less likely to receive cryoprecipitate (0% versus 15/114 [13%], p = .02). Intermediate-risk CLL patients received more platelet units, mean 12 versus 4.6 (p = 0.008). Occurrence of deep sternal wound infection (0% versus 5/471 [1.1%]), septicemia (5/157 [3.2%] versus 14/471 [3.0%]), and hospital mortality (4/157 [2.5%] versus 14/471 [3.0%]) were similar (p > 0.3), independent of prior chemotherapy treatment for CLL. Although CLL patients did not have higher hospital mortality than non-CLL patients, high-risk CLL patients were more likely to receive blood products. Risks associated with transfusion should be considered when evaluating CLL patients for elective cardiac surgery. Appropriate preoperative management, such as blood product transfusions, and alternative treatment options that decrease blood loss, should be considered for high-risk patients. Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  7. Cardiac rehabilitation adapted to transient ischaemic attack and stroke (CRAFTS: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Blake Catherine

    2009-02-01

    Full Text Available Abstract Background Coronary Heart Disease and Cerebrovascular Disease share many predisposing, modifiable risk factors (hypertension, abnormal blood lipids and lipoproteins, cigarette smoking, physical inactivity, obesity and diabetes mellitus. Lifestyle interventions and pharmacological therapy are recognised as the cornerstones of secondary prevention. Cochrane review has proven the benefits of programmes incorporating exercise and lifestyle counselling in the cardiac disease population. A Cochrane review highlighted as priority, the need to establish feasibility and efficacy of exercise based interventions for Cerebrovascular Disease. Methods A single blind randomised controlled trial is proposed to examine a primary care cardiac rehabilitation programme for adults post transient ischemic attack (TIA and stroke in effecting a positive change in the primary outcome measures of cardiac risk scores derived from Blood Pressure, lipid profile, smoking and diabetic status and lifestyle factors of habitual smoking, exercise and healthy eating participation. Secondary outcomes of interest include health related quality of life as measured by the Hospital Anxiety and Depression Scale, the Stroke Specific Quality of Life scale and WONCA COOP Functional Health Status charts and cardiovascular fitness as measured by a sub-maximal fitness test. A total of 144 patients, over 18 years of age with confirmed diagnosis of ischaemic stroke or TIA, will be recruited from Dublin community stroke services and two tertiary T.I.A clinics. Exclusion criteria will include oxygen dependence, unstable cardiac conditions, uncontrolled diabetes, major medical conditions, claudication, febrile illness, pregnancy or cognitive impairment. Participants will be block-statified, randomly allocated to one of two groups using a pre-prepared computer generated randomisation schedule. Both groups will receive a two hour education class on risk reduction post stroke. The

  8. Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments: A Systematic Review of the Published Literature

    Science.gov (United States)

    Sinha, Shashank S.; Sukul, Devraj; Lazarus, John J.; Polavarapu, Vivek; Chan, Paul S.; Neumar, Robert W.; Nallamothu, Brahmajee K.

    2016-01-01

    Background Cardiac arrests are a major public health concern worldwide. The extent and types of randomized controlled trials (RCTs) – our most reliable source of clinical evidence – conducted in these high-risk patients over recent years are largely unknown. Methods and Results We performed a systematic review, identifying all RCTs published in PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library from 1995 to 2014 that focused on acute treatment of non-traumatic cardiac arrest in adults. We then extracted data on the setting of study populations, types and timing of interventions studied, risk of bias, outcomes reported and how these factors have changed over time. Over this twenty-year period, 92 RCTs were published containing 64,309 patients (median, 225.5 per trial). Of these, 81 RCTs (88.0%) involved out-of-hospital cardiac arrest whereas 4 (4.3%) involved in-hospital cardiac arrest and 7 (7.6%) included both. Eighteen RCTs (19.6%) were performed in the U.S., 68 (73.9%) were performed outside the U.S., and 6 (6.5%) were performed in both settings. Thirty-eight RCTs (41.3%) evaluated drug therapy, 39 (42.4%) evaluated device therapy, and 15 (16.3%) evaluated protocol improvements. Seventy-four RCTs (80.4%) examined interventions during the cardiac arrest, 15 (16.3%) examined post-cardiac arrest treatment, and 3 (3.3%) studied both. Overall, reporting of risk of bias was limited. The most common outcome reported was ROSC: 86 (93.5%) with only 22 (23.9%) reporting survival beyond 6 months. Fifty-three RCTs (57.6%) reported global ordinal outcomes whereas 15 (16.3%) reported quality-of-life. RCTs in the last 5 years were more likely to be focused on protocol improvement and post-cardiac arrest care. Conclusions Important gaps in RCTs of cardiac arrest treatments exist, especially those examining in-hospital cardiac arrest, protocol improvement, post-cardiac arrest care, and long-term or quality-of-life outcomes. PMID:27756794

  9. Dysglycemia, Glycemic Variability, and Outcome After Cardiac Arrest and Temperature Management at 33°C and 36°C

    DEFF Research Database (Denmark)

    Borgquist, Ola; Wise, Matt P; Nielsen, Niklas

    2017-01-01

    OBJECTIVES: Dysglycemia and glycemic variability are associated with poor outcomes in critically ill patients. Targeted temperature management alters blood glucose homeostasis. We investigated the association between blood glucose concentrations and glycemic variability and the neurologic outcomes...... of patients randomized to targeted temperature management at 33°C or 36°C after cardiac arrest. DESIGN: Post hoc analysis of the multicenter TTM-trial. Primary outcome of this analysis was neurologic outcome after 6 months, referred to as "Cerebral Performance Category." SETTING: Thirty-six sites in Europe...... and Australia. PATIENTS: All 939 patients with out-of-hospital cardiac arrest of presumed cardiac cause that had been included in the TTM-trial. INTERVENTIONS: Targeted temperature management at 33°C or 36°C. MEASUREMENTS AND MAIN RESULTS: Nonparametric tests as well as multiple logistic regression and mixed...

  10. Deep breathing exercises performed 2 months following cardiac surgery: a randomized controlled trial.

    Science.gov (United States)

    Westerdahl, Elisabeth; Urell, Charlotte; Jonsson, Marcus; Bryngelsson, Ing-Liss; Hedenström, Hans; Emtner, Margareta

    2014-01-01

    Postoperative breathing exercises are recommended to cardiac surgery patients. Instructions concerning how long patients should continue exercises after discharge vary, and the significance of treatment needs to be determined. Our aim was to assess the effects of home-based deep breathing exercises performed with a positive expiratory pressure device for 2 months following cardiac surgery. The study design was a prospective, single-blinded, parallel-group, randomized trial. Patients performing breathing exercises 2 months after cardiac surgery (n = 159) were compared with a control group (n = 154) performing no breathing exercises after discharge. The intervention consisted of 30 slow deep breaths performed with a positive expiratory pressure device (10-15 cm H2O), 5 times a day, during the first 2 months after surgery. The outcomes were lung function measurements, oxygen saturation, thoracic excursion mobility, subjective perception of breathing and pain, patient-perceived quality of recovery (40-Item Quality of Recovery score), health-related quality of life (36-Item Short Form Health Survey), and self-reported respiratory tract infection/pneumonia and antibiotic treatment. Two months postoperatively, the patients had significantly reduced lung function, with a mean decrease in forced expiratory volume in 1 second to 93 ± 12% (P< .001) of preoperative values. Oxygenation had returned to preoperative values, and 5 of 8 aspects in the 36-Item Short Form Health Survey were improved compared with preoperative values (P< .01). There were no significant differences between the groups in any of the measured outcomes. No significant differences in lung function, subjective perceptions, or quality of life were found between patients performing home-based deep breathing exercises and control patients 2 months after cardiac surgery.

  11. Physical therapy intervention in patients with non-cardiac chest pain following a recent cardiac event: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Astrid T Berg

    2015-04-01

    Full Text Available Objectives: To assess the effect of two different physical therapy interventions in patients with stable coronary heart disease and non-cardiac chest pain. Methods: A randomized controlled trial was carried out at a university hospital in Norway. A total of 30 patients with known and stable coronary heart disease and self-reported persistent chest pain reproduced by palpation of intercostal trigger points were participating in the study. The intervention was deep friction massage and heat pack versus heat pack only. The primary outcome was pain intensity after the intervention period and 3 months after the last treatment session, measured by Visual Analogue Scale, 0 to 100. Secondary outcome was health-related quality of life. Results: Treatment with deep friction massage and heat pack gave significant pain reduction compared to heat pack only (–17.6, 95% confidence interval: –30.5, –4.7; p < 0.01, and the reduction was persistent at 3 months’ follow-up (–15.2, 95% confidence interval: –28.5, –1.8; p = 0.03. Health-related quality of life improved in all three domains in patients with no significant difference between groups. Conclusion: Deep friction massage combined with heat pack is an efficient treatment of musculoskeletal chest pain in patients with stable coronary heart disease.

  12. Perinatal management and long-term cardiac outcome in fetal arrhythmia

    NARCIS (Netherlands)

    Hahurij, N.D.; Blom, N.A.; Lopriore, E.; Aziz, M.I.; Nagel, H.T.; Rozendaal, L.; Vandenbussche, F.P.H.A.

    2011-01-01

    BACKGROUND: cardiac arrhythmias are commonly observed in the fetus, however, may have major consequences for fetal development and post natal life. AIMS: to evaluate the perinatal management and cardiac outcome of fetuses with tachy- or bradyarrhythmia. STUDY DESIGN: perinatal management, outcome

  13. Outcome of out-of-hospital cardiac arrest--why do physicians withhold resuscitation attempts?

    DEFF Research Database (Denmark)

    Horsted, Tina I; Rasmussen, Lars S; Lippert, Freddy K

    2004-01-01

    To describe the outcome of out-of-hospital cardiac arrest (OHCA) with a focus on why physicians withhold resuscitation attempts.......To describe the outcome of out-of-hospital cardiac arrest (OHCA) with a focus on why physicians withhold resuscitation attempts....

  14. Infertility trial outcomes: healthy moms and babies.

    Science.gov (United States)

    Silver, Robert

    2014-05-01

    Traditionally, the primary outcome of infertility trials has been a positive pregnancy test or a clinically recognized pregnancy. However, parents desire a healthy baby that grows up to be a healthy adult, rather than a positive pregnancy test. Too often results of infertility trials are lacking in crucial obstetric details. This is problematic because treatments for infertility have the capacity to increase the risk for a variety of adverse obstetric outcomes. This review will outline important obstetric variables that should be included when reporting infertility research. The rationale for including these data, precise definitions of the variables, and cost-effective strategies for obtaining these obstetric details will be highlighted. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  15. Bystander Automated External Defibrillator Use and Clinical Outcomes after Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Holmberg, Mathias J; Vognsen, Mikael; Andersen, Mikkel S

    2017-01-01

    Aim: To systematically review studies comparing bystander automated external defibrillator (AED) use to no AED use in regard to clinical outcomes in out-of-hospital cardiac arrest (OHCA), and to provide a descriptive summary of studies on the cost-effectiveness of bystander AED use. Methods: We...... randomized trials, and 13 cost-effectiveness studies were included. Meta-analysis of 6 observational studies without critical risk of bias showed that bystander AED use was associated with survival to hospital discharge (all rhythms OR: 1.73 [95% CI: 1.36, 2.18], shockable rhythms OR: 1.66 [95% CI: 1.54, 1.......79]) and favorable neurological outcome (all rhythms OR: 2.12 [95% CI: 1.36, 3.29], shockable rhythms OR: 2.37 [95% CI: 1.58, 3.57]). There was no association between bystander AED use and neurological outcome for non-shockable rhythms (OR: 0.76 [95% CI: 0.10, 5.87]). The Public-Access Defibrillation trial found...

  16. Contribution of cardiac and extra-cardiac disease burden to risk of cardiovascular outcomes varies by ejection fraction in heart failure

    DEFF Research Database (Denmark)

    Wolsk, Emil; Claggett, Brian; Køber, Lars

    2018-01-01

    AIMS: Patients with heart failure (HF) often have multiple co-morbidities that contribute to the risk of adverse cardiovascular (CV) and non-CV outcomes. We assessed the relative contribution of cardiac and extra-cardiac disease burden and demographic factors to CV outcomes in HF patients...... Association class, systolic blood pressure, time since HF diagnosis, HF medication use), extra-cardiac (body mass index, creatinine, diabetes mellitus, chronic obstructive pulmonary disease, smoker), and demographic (age, gender) categories, and calculated subscores for each patient representing the burden......EF patients (PAR: 76% cardiac disease vs. 58% extra-cardiac disease, P vs. 49% extra-cardiac disease, P

  17. Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Winkel, Per; Cronberg, Tobias

    2013-01-01

    Animal experimental studies and previous randomized trials suggest an improvement in mortality and neurological function with temperature regulation to hypothermia after cardiac arrest. According to a systematic review, previous trials were small, had a risk of bias, evaluated select populations......, and did not treat hyperthermia in the control groups. The optimal target temperature management (TTM) strategy is not known. To prevent outcome reporting bias, selective reporting and data-driven results, we present the a priori defined detailed statistical analysis plan as an update to the previously...

  18. Pre-hospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug administration In Cardiac arrest (PARAMEDIC-2): Trial protocol.

    Science.gov (United States)

    Perkins, Gavin D; Quinn, Tom; Deakin, Charles D; Nolan, Jerry P; Lall, Ranjit; Slowther, Anne-Marie; Cooke, Matthew; Lamb, Sarah E; Petrou, Stavros; Achana, Felix; Finn, Judith; Jacobs, Ian G; Carson, Andrew; Smyth, Mike; Han, Kyee; Byers, Sonia; Rees, Nigel; Whitfield, Richard; Moore, Fionna; Fothergill, Rachael; Stallard, Nigel; Long, John; Hennings, Susie; Horton, Jessica; Kaye, Charlotte; Gates, Simon

    2016-11-01

    Despite its use since the 1960s, the safety or effectiveness of adrenaline as a treatment for cardiac arrest has never been comprehensively evaluated in a clinical trial. Although most studies have found that adrenaline increases the chance of return of spontaneous circulation for short periods, many studies found harmful effects on the brain and raise concern that adrenaline may reduce overall survival and/or good neurological outcome. The PARAMEDIC-2 trial seeks to determine if adrenaline is safe and effective in out-of-hospital cardiac arrest. This is a pragmatic, individually randomised, double blind, controlled trial with a parallel economic evaluation. Participants will be eligible if they are in cardiac arrest in the out-of-hospital environment and advanced life support is initiated. Exclusions are cardiac arrest as a result of anaphylaxis or life threatening asthma, and patient known or appearing to be under 16 or pregnant. 8000 participants treated by 5 UK ambulance services will be randomised between December 2014 and August 2017 to adrenaline (intervention) or placebo (control) through opening pre-randomised drug packs. Clinical outcomes are survival to 30 days (primary outcome), hospital discharge, 3, 6 and 12 months, health related quality of life, and neurological and cognitive outcomes (secondary outcomes). Trial registration (ISRCTN73485024). Copyright © 2016 The Author(s). Published by Elsevier Ireland Ltd.. All rights reserved.

  19. Enhanced pyruvate dehydrogenase activity improves cardiac outcomes in a murine model of cardiac arrest.

    Directory of Open Access Journals (Sweden)

    Lin Piao

    Full Text Available Post-ischemic changes in cellular metabolism alter myocardial and neurological function. Pyruvate dehydrogenase (PDH, the limiting step in mitochondrial glucose oxidation, is inhibited by increased expression of PDH kinase (PDK during ischemia/reperfusion injury. This results in decreased utilization of glucose to generate cellular ATP. Post-cardiac arrest (CA hypothermia improves outcomes and alters metabolism, but its influence on PDH and PDK activity following CA are unknown. We hypothesized that therapeutic hypothermia (TH following CA is associated with the inhibition of PDK activity and increased PDH activity. We further hypothesized that an inhibitor of PDK activity, dichloroacetate (DCA, would improve PDH activity and post-CA outcomes.Anesthetized and ventilated adult female C57BL/6 wild-type mice underwent a 12-minute KCl-induced CA followed by cardiopulmonary resuscitation. Compared to normothermic (37°C CA controls, administering TH (30°C improved overall survival (72-hour survival rate: 62.5% vs. 28.6%, P<0.001, post-resuscitation myocardial function (ejection fraction: 50.9±3.1% vs. 27.2±2.0%, P<0.001; aorta systolic pressure: 132.7±7.3 vs. 72.3±3.0 mmHg, P<0.001, and neurological scores at 72-hour post CA (9.5±1.3 vs. 5.4±1.3, P<0.05. In both heart and brain, CA increased lactate concentrations (1.9-fold and 3.1-fold increase, respectively, P<0.01, decreased PDH enzyme activity (24% and 50% reduction, respectively, P<0.01, and increased PDK protein expressions (1.2-fold and 1.9-fold, respectively, P<0.01. In contrast, post-CA treatment with TH normalized lactate concentrations (P<0.01 and P<0.05 and PDK expressions (P<0.001 and P<0.05, while increasing PDH activity (P<0.01 and P<0.01 in both the heart and brain. Additionally, treatment with DCA (0.2 mg/g body weight 30 min prior to CA improved both myocardial hemodynamics 2 hours post-CA (aortic systolic pressure: 123±3 vs. 96±4 mmHg, P<0.001 and 72-hour survival rates

  20. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients.

    Science.gov (United States)

    Denault, André Y; Bussières, Jean S; Arellano, Ramiro; Finegan, Barry; Gavra, Paul; Haddad, François; Nguyen, Anne Q N; Varin, France; Fortier, Annik; Levesque, Sylvie; Shi, Yanfen; Elmi-Sarabi, Mahsa; Tardif, Jean-Claude; Perrault, Louis P; Lambert, Jean

    2016-10-01

    Inhaled milrinone (iMil) has been used for the treatment of pulmonary hypertension (PH) but its efficacy, safety, and prophylactic effects in facilitating separation from cardiopulmonary bypass (CPB) and preventing right ventricular (RV) dysfunction have not yet been evaluated in a clinical trial. The purpose of this study was to investigate if iMil administered before CPB would be superior to placebo in facilitating separation from CPB. High-risk cardiac surgical patients with PH were randomized to receive iMil or placebo after the induction of anesthesia and before CPB. Hemodynamic parameters and RV function were evaluated by means of pulmonary artery catheterization and transesophageal echocardiography. The groups were compared for the primary outcome of the level of difficulty in weaning from CPB. Among the secondary outcomes examined were the reduction in the severity of PH, the incidence of RV failure, and mortality. Of the 124 patients randomized, the mean (standard deviation [SD]) EuroSCORE II was 8.0 (2.6), and the baseline mean (SD) systolic pulmonary artery pressure (SPAP) was 53 (9) mmHg. The use of iMil was associated with increases in cardiac output (P = 0.03) and a reduction in SPAP (P = 0.04) with no systemic hypotension. Nevertheless, there was no difference in the combined incidence of difficult or complex separation from CPB between the iMil and control groups (30% vs 28%, respectively; absolute difference, 2%; 95% confidence interval [CI], -14 to 18; P = 0.78). There was also no difference in RV failure between the iMil and control groups (15% vs 14%, respectively; difference, 1%; 95% CI, -13 to 12; P = 0.94). Mortality was increased in patients with RV failure vs those without (22% vs 2%, respectively; P < 0.001). In high-risk cardiac surgery patients with PH, the prophylactic use of iMil was associated with favourable hemodynamic effects that did not translate into improvement of clinically relevant endpoints. This trial was registered at

  1. Cardiac stress test as a risk-stratification tool for posttransplant cardiac outcomes in diabetic kidney transplant recipients.

    Science.gov (United States)

    Singh, Neeraj; Parikh, Samir; Bhatt, Udayan; Vonvisger, Jon; Nori, Uday; Hasan, Ayesha; Samavedi, Srinivas; Andreoni, Kenneth; Henry, Mitchell; Pelletier, Ronald; Rajab, Amer; Elkhammas, Elmahdi; Pesavento, Todd

    2012-12-27

    The utility of cardiac stress testing as a risk-stratification tool before kidney transplantation remains debatable owing to discordance with coronary angiography and outcome yields at different centers. We conducted a retrospective study of 273 diabetic kidney transplant recipients from 2006 to 2010. By protocol, all diabetic patients underwent pharmacological radionucleotide stress test or dobutamine stress echocardiography before transplant. We compared the 1-year cardiac outcomes between those with negative stress test results and those with positive stress test results. Patients with a positive stress test result (n=67) underwent coronary angiogram, and significant coronary artery disease (≥70% coronary stenosis) was found in 35 (52.2%) patients. Of the latter, 32 (91.4%) underwent cardiac revascularization (24 underwent cardiac stenting and 8 underwent coronary artery bypass grafting). The rest (n=35) were treated medically. Within 1 year after transplant, the group with positive stress test results experienced more cardiac events (34.3% vs. 3.9%, P<0.001) including acute myocardial infarction (22.4% vs. 3.4%, P<0.001) and ventricular arrhythmias (8.9% vs. 0.05%, P=0.001), higher all-cause mortality (19.4% vs. 4.8%, P<0.001), and cardiac mortality (17.9% vs. 0.9%, P<0.001) compared with the group with negative stress test results. In this diabetic population, stress testing showed positive and negative predictive values of 34.3% and 96.1%, respectively. Pharmacological cardiac stress testing provided excellent risk stratification in diabetic kidney transplant recipients.

  2. Chest compressions before defibrillation for out-of-hospital cardiac arrest: A meta-analysis of randomized controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Meier Pascal

    2010-09-01

    Full Text Available Abstract Background Current 2005 guidelines for advanced cardiac life support strongly recommend immediate defibrillation for out-of-hospital cardiac arrest. However, findings from experimental and clinical studies have indicated a potential advantage of pretreatment with chest compression-only cardiopulmonary resuscitation (CPR prior to defibrillation in improving outcomes. The aim of this meta-analysis is to evaluate the beneficial effect of chest compression-first versus defibrillation-first on survival in patients with out-of-hospital cardiac arrest. Methods Main outcome measures were survival to hospital discharge (primary endpoint, return of spontaneous circulation (ROSC, neurologic outcome and long-term survival. Randomized, controlled clinical trials that were published between January 1, 1950, and June 19, 2010, were identified by a computerized search using SCOPUS, MEDLINE, BIOS, EMBASE, the Cochrane Central Register of Controlled Trials, International Pharmaceutical Abstracts database, and Web of Science and supplemented by conference proceedings. Random effects models were used to calculate pooled odds ratios (ORs. A subgroup analysis was conducted to explore the effects of response interval greater than 5 min on outcomes. Results A total of four trials enrolling 1503 subjects were integrated into this analysis. No difference was found between chest compression-first versus defibrillation-first in the rate of return of spontaneous circulation (OR 1.01 [0.82-1.26]; P = 0.979, survival to hospital discharge (OR 1.10 [0.70-1.70]; P = 0.686 or favorable neurologic outcomes (OR 1.02 [0.31-3.38]; P = 0.979. For 1-year survival, however, the OR point estimates favored chest compression first (OR 1.38 [0.95-2.02]; P = 0.092 but the 95% CI crossed 1.0, suggesting insufficient estimate precision. Similarly, for cases with prolonged response times (> 5 min point estimates pointed toward superiority of chest compression first (OR 1.45 [0

  3. Neonatal outcomes in fetuses with cardiac anomalies and the impact of delivery route.

    Science.gov (United States)

    Parikh, Laura I; Grantz, Katherine L; Iqbal, Sara N; Huang, Chun-Chih; Landy, Helain J; Fries, Melissa H; Reddy, Uma M

    2017-10-01

    Congenital fetal cardiac anomalies compromise the most common group of fetal structural anomalies. Several previous reports analyzed all types of fetal cardiac anomalies together without individualized neonatal morbidity outcomes based on cardiac defect. Mode of delivery in cases of fetal cardiac anomalies varies greatly as optimal mode of delivery in these complex cases is unknown. We sought to determine rates of neonatal outcomes for fetal cardiac anomalies and examine the role of attempted route of delivery on neonatal morbidity. Gravidas with fetal cardiac anomalies and delivery >34 weeks, excluding stillbirths and aneuploidies (n = 2166 neonates, n = 2701 cardiac anomalies), were analyzed from the Consortium on Safe Labor, a retrospective cohort study of electronic medical records. Cardiac anomalies were determined using International Classification of Diseases, Ninth Revision codes and organized based on morphology. Neonates were assigned to each cardiac anomaly classification based on the most severe cardiac defect present. Neonatal outcomes were determined for each fetal cardiac anomaly. Composite neonatal morbidity (serious respiratory morbidity, sepsis, birth trauma, hypoxic ischemic encephalopathy, and neonatal death) was compared between attempted vaginal delivery and planned cesarean delivery for prenatal and postnatal diagnosis. We used multivariate logistic regression to calculate adjusted odds ratio for composite neonatal morbidity controlling for race, parity, body mass index, insurance, gestational age, maternal disease, single or multiple anomalies, and maternal drug use. Most cardiac anomalies were diagnosed postnatally except hypoplastic left heart syndrome, which had a higher prenatal than postnatal detection rate. Neonatal death occurred in 8.4% of 107 neonates with conotruncal defects. Serious respiratory morbidity occurred in 54.2% of 83 neonates with left ventricular outflow tract defects. Overall, 76.3% of pregnancies with fetal

  4. The outcome of anaesthesia related cardiac arrest in a

    Directory of Open Access Journals (Sweden)

    O.O. Adekola

    2016-07-01

    Conclusion: Anaesthesia related cardiac arrest and mortality were linked to cardiovascular depression from halothane overdose in our institution. The burden can be reduced by improving on establishing standard monitoring in the perioperative period, and a team approach to patients care.

  5. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled

    DEFF Research Database (Denmark)

    Dahlöf, Björn; Sever, Peter S; Poulter, Neil R

    2005-01-01

    The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics...

  6. Long-term outcome after an early invasive versus selective invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome and elevated cardiac troponin T (the ICTUS trial): a follow-up study.

    NARCIS (Netherlands)

    Hirsch, A.; Windhausen, F.; Tijssen, J.G.P.; Verheugt, F.W.A.; Cornel, J.H.; Winter, R.J. de

    2007-01-01

    BACKGROUND: The ICTUS trial was a study that compared an early invasive with a selective invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (nSTE-ACS). The study reported no difference between the strategies for frequency of death, myocardial infarction, or

  7. Long-term outcome after an early invasive versus selective invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome and elevated cardiac troponin T (the ICTUS trial): a follow-up study

    NARCIS (Netherlands)

    Hirsch, Alexander; Windhausen, Fons; Tijssen, Jan G. P.; Verheugt, Freek W. A.; Hein Cornel, Jan; de Winter, Robbert J.

    2007-01-01

    BACKGROUND: The ICTUS trial was a study that compared an early invasive with a selective invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (nSTE-ACS). The study reported no difference between the strategies for frequency of death, myocardial infarction, or

  8. A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial.

    Science.gov (United States)

    Dainty, Katie N; Scales, Damon C; Brooks, Steve C; Needham, Dale M; Dorian, Paul; Ferguson, Niall; Rubenfeld, Gordon; Wax, Randy; Zwarenstein, Merrick; Thorpe, Kevin; Morrison, Laurie J

    2011-01-14

    Advances in resuscitation science have dramatically improved survival rates following cardiac arrest. However, about 60% of adults that regain spontaneous circulation die before leaving the hospital. Recently it has been shown that inducing hypothermia in cardiac arrest survivors immediately following their arrival in hospital can dramatically improve both overall survival and neurological outcomes. Despite the strong evidence for its efficacy and the apparent simplicity of this intervention, recent surveys show that therapeutic hypothermia is delivered inconsistently, incompletely, and often with delay. This study will evaluate a multi-faceted knowledge translation strategy designed to increase the utilization rate of induced hypothermia in survivors of cardiac arrest across a network of 37 hospitals in Southwestern Ontario, Canada. The study is designed as a stepped wedge randomized trial lasting two years. Individual hospitals will be randomly assigned to four different wedges that will receive the active knowledge translation strategy according to a sequential rollout over a number of time periods. By the end of the study, all hospitals will have received the intervention. The primary aim is to measure the effectiveness of a multifaceted knowledge translation plan involving education, reminders, and audit-feedback for improving the use of induced hypothermia in survivors of cardiac arrest presenting to the emergency department. The primary outcome is the proportion of eligible OHCA patients that are cooled to a body temperature of 32 to 34°C within six hours of arrival in the hospital. Secondary outcomes will include process of care measures and clinical outcomes. Inducing hypothermia in cardiac arrest survivors immediately following their arrival to hospital has been shown to dramatically improve both overall survival and neurological outcomes. However, this lifesaving treatment is frequently not applied in practice. If this trial is positive, our results

  9. A Randomized Clinical Trial of Red Blood Cell Transfusion Triggers in Cardiac Surgery.

    Science.gov (United States)

    Koch, Colleen G; Sessler, Daniel I; Mascha, Edward J; Sabik, Joseph F; Li, Liang; Duncan, Andra I; Zimmerman, Nicole M; Blackstone, Eugene H

    2017-10-01

    Class I evidence supporting a threshold for transfusion in the cardiac surgical setting is scarce. We randomly allocated patients to a transfusion hematocrit trigger of 24% versus 28% to compare morbidity, mortality, and resource use. From March 2007 to August 2014, two centers randomly assigned 722 adults undergoing coronary artery bypass graft surgery or valve procedures to a 24% hematocrit trigger (n = 363, low group) or 28% trigger (n = 354, high group). One unit of red blood cells was transfused if the hematocrit fell below the designated threshold. The primary endpoint was a composite of postoperative morbidities and mortality. Treatment effect was primarily assessed using an average relative effect generalized estimating equation model. At the second planned interim analysis, the a priori futility boundary was crossed, and the study was stopped. There was no detected treatment effect on the composite outcome (average relative effect odds ratio, low versus high, 0.86, 95% confidence interval: 0.29 to 2.54, p = 0.71). However, the low group received fewer red blood cell transfusions than the high group (54% versus 75%, p < 0.001), mostly administered in the operating room (low group, 112 [31%]; high group, 208 [59%]), followed by intensive care unit (low, 105 [31%]; high, 115 [34%]) and floor (low, 41 [12%]; high, 42 [13%]). The low group was exposed to lower hematocrits: median before transfusion, 22% (Q1 = 21%, Q3 = 23%) versus 24% (Q1 = 22%, Q3 = 25%). Negative exposures differed between treatment groups, with lower hematocrit in the 24% trigger group and more red blood cells used in the 28% group, but adverse outcomes did not differ. Because red blood cell use was less with a 24% trigger without adverse effects, our randomized trial results support aggressive blood conservation efforts in cardiac surgery. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  10. Outcome of community-acquired pneumonia with cardiac complications

    Directory of Open Access Journals (Sweden)

    R. Eman Shebl

    2015-07-01

    Conclusions: Cardiac complications are common in the admitted patients with pneumonia and they are associated with increased pneumonia severity and increased cardiovascular risk, these complications adds to the risk of mortality, so optimal management of these events may reduce the burden of death associated with this infection.

  11. Outcomes After Cardiac Arrest in an Adult Burn Center

    Science.gov (United States)

    2013-12-07

    of in-hospital CA are likely to report widely varying survival rates as a result of study populations with characteristic but distinct demo- graphics ...Rehabil 1997;18:S119. [2] Sandroni C, Nolan J. In-hospital cardiac arrest: incidence, prognosis and possible measures to improve survival. Intens Care Med

  12. Impact of the viral respiratory season on postoperative outcomes in children undergoing cardiac surgery.

    Science.gov (United States)

    Spaeder, Michael C; Carson, Kathryn A; Vricella, Luca A; Alejo, Diane E; Holmes, Kathryn W

    2011-08-01

    To compare postoperative outcomes in children undergoing cardiac surgery during the viral respiratory season and nonviral season at our institution. This was a retrospective cohort study and secondary matched case-control analysis. The setting was an urban academic tertiary-care children's hospital. The study was comprised of all patients <18 years of age who underwent cardiac surgery at Johns Hopkins Hospital from October 2002 through September 2007. Patients were stratified by season of surgery, complexity of cardiac disease, and presence or absence of viral respiratory infection. Measurements included patient characteristics and postoperative outcomes. The primary outcome was postoperative length of stay (LOS). A total of 744 patients were included in the analysis. There was no difference in baseline characteristics or outcomes, specifically, no difference in postoperative LOS, intensive care unit (ICU) LOS, and mortality, among patients by seasons of surgery. Patients with viral respiratory illness were more likely to have longer postoperative LOS (p < 0.01) and ICU LOS (p < 0.01) compared with matched controls. We identified no difference in postoperative outcomes based on season in patients undergoing cardiac surgery. Children with viral respiratory infection have significantly worse outcomes than matched controls, strengthening the call for universal administration of influenza vaccination and palivizumab to appropriate groups. Preoperative testing for respiratory viruses should be considered during the winter months for children undergoing elective cardiac surgery.

  13. Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.

    Science.gov (United States)

    Caterson, I D; Finer, N; Coutinho, W; Van Gaal, L F; Maggioni, A P; Torp-Pedersen, C; Sharma, A M; Legler, U F; Shepherd, G M; Rode, R A; Perdok, R J; Renz, C L; James, W P T

    2012-06-01

    The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Overweight/obese subjects (N = 10 744), ≥55 years with cardiovascular disease and/or type 2 diabetes mellitus, received sibutramine plus weight management during a 6-week Lead-in Period before randomization to continue sibutramine (N = 4906) or to receive placebo (N = 4898). The primary endpoint was the time from randomization to first occurrence of a primary outcome event (non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death). For the total population, mean weight change during Lead-in Period (sibutramine) was -2.54 kg. Post-randomization, mean total weight change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although more events occurred in the randomized sibutramine group, on an average, a modest weight loss of approximately 3 kg achieved in the Lead-in Period appeared to offset this increased event rate. Moderate weight loss (3-10 kg) reduced cardiovascular deaths in those with severe, moderate or mild cardiovascular disease. Modest weight loss over short-term (6 weeks) and longer-term (6-12 months) periods is associated with reduction in subsequent cardiovascular mortality for the following 4-5 years even in those with pre-existing cardiovascular disease. While the sibutramine group experienced more primary outcome events than the placebo group, greater weight loss reduced overall risk of these occurring in both groups. © 2011 Blackwell Publishing Ltd.

  14. Management and outcome of cardiac and endovascular cystic echinococcosis.

    Directory of Open Access Journals (Sweden)

    Marta Díaz-Menéndez

    2012-01-01

    Full Text Available BACKGROUND: Cystic echinococcosis (CE can affect the heart and the vena cava but few cases are reported. METHODS: A retrospective case series of 11 patients with cardiac and/or endovascular CE, followed-up over a period of 15 years (1995-2009 is reported. RESULTS: Main clinical manifestations included thoracic pain or dyspnea, although 2 patients were asymptomatic. Cysts were located mostly in the right atrium and inferior vena cava. Nine patients were previously diagnosed with disseminated CE. Echocardiography was the diagnostic method of choice, although serology, electrocardiogram, chest X-ray, computed tomography/magnetic resonance imaging and histology aided with diagnosis and follow-up. Nine patients underwent cardiac surgery and nine received long-term antiparasitic treatment for a median duration of 25 months (range 4-93 months. One patient died intra-operatively due to cyst rupture and endovascular dissemination. Two patients died 10 and 14 years after diagnosis, due to pulmonary embolism (PE and cardiac failure, respectively. One patient was lost to follow-up. Patients who had cardiac involvement exclusively did not have complications after surgery and were considered cured. There was only one recurrence requiring a second operation. Patients with vena cava involvement developed PEs and presented multiple complications. CONCLUSIONS: Cardiovascular CE is associated with a high risk of potentially lethal complications. Clinical manifestations and complications vary according to cyst location. Isolated cardiac CE may be cured after surgery, while endovascular extracardiac involvement is associated with severe chronic complications. CE should be included in the differential diagnosis of cardiovascular disease in patients from endemic areas.

  15. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

  16. Adrenaline for out-of-hospital cardiac arrest resuscitation: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Lin, Steve; Callaway, Clifton W; Shah, Prakesh S; Wagner, Justin D; Beyene, Joseph; Ziegler, Carolyn P; Morrison, Laurie J

    2014-06-01

    The evidence for adrenaline in out-of-hospital cardiac arrest (OHCA) resuscitation is inconclusive. We systematically reviewed the efficacy of adrenaline for adult OHCA. We searched in MEDLINE, EMBASE, and Cochrane Library from inception to July 2013 for randomized controlled trials (RCTs) evaluating standard dose adrenaline (SDA) to placebo, high dose adrenaline (HDA), or vasopressin (alone or combination) in adult OHCA patients. Meta-analyses were performed using random effects modeling. Subgroup analyses were performed stratified by cardiac rhythm and by number of drug doses. The primary outcome was survival to discharge and the secondary outcomes were return of spontaneous circulation (ROSC), survival to admission, and neurological outcome. Fourteen RCTs (n=12,246) met inclusion criteria: one compared SDA to placebo (n=534), six compared SDA to HDA (n=6174), six compared SDA to an adrenaline/vasopressin combination (n=5202), and one compared SDA to vasopressin alone (n=336). There was no survival to discharge or neurological outcome differences in any comparison group, including subgroup analyses. SDA showed improved ROSC (RR 2.80, 95%CI 1.78-4.41, padrenaline. There was no benefit of adrenaline in survival to discharge or neurological outcomes. There were improved rates of survival to admission and ROSC with SDA over placebo and HDA over SDA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  17. Prolonged cardiopulmonary resuscitation and outcomes after out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Rajan, Shahzleen; Folke, Fredrik; Kragholm, Kristian

    2016-01-01

    AIM: It is unclear whether prolonged resuscitation can result in successful outcome following out-of-hospital cardiac arrests (OHCA). We assessed associations between duration of pre-hospital resuscitation on survival and functional outcome following OHCA in patients achieving pre-hospital return...

  18. Comprehensive cardiac rehabilitation improves outcome for patients with implantable cardioverter defibrillator

    DEFF Research Database (Denmark)

    Berg, Selina Kikkenborg; Pedersen, Preben Ulrich; Zwisler, Ann-Dorthe

    2015-01-01

    year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes. Two primary outcomes, general health score (Short Form-36 (SF-36)) and peak oxygen uptake (VO2), were used. Post-hoc analyses included SF-36 and ICD therapy history.Results:Comprehensive cardiac...

  19. Differential effects of aprotinin and tranexamic acid on outcomes and cytokine profiles in neonates undergoing cardiac surgery.

    Science.gov (United States)

    Graham, Eric M; Atz, Andrew M; Gillis, Jenna; Desantis, Stacia M; Haney, A Lauren; Deardorff, Rachael L; Uber, Walter E; Reeves, Scott T; McGowan, Francis X; Bradley, Scott M; Spinale, Francis G

    2012-05-01

    Factors contributing to postoperative complications include blood loss and a heightened inflammatory response. The objective of this study was to test the hypothesis that aprotinin would decrease perioperative blood product use, reduce biomarkers of inflammation, and result in improved clinical outcome parameters in neonates undergoing cardiac operations. This was a secondary retrospective analysis of a clinical trial whereby neonates undergoing cardiac surgery received either aprotinin (n = 34; before May 2008) or tranexamic acid (n = 42; after May 2008). Perioperative blood product use, clinical course, and measurements of cytokines were compared. Use of perioperative red blood cells, cryoprecipitate, and platelets was reduced in neonates receiving aprotinin compared with tranexamic acid (P factor VII use (2/34 [6%] vs 18/42 [43%]; P Production of tumor necrosis factor and interleukin-2 activation were attenuated in the aprotinin group at 24 hours postoperatively. No differential effects on renal function were seen between agents. Aprotinin, compared with tranexamic acid, was associated with reduced perioperative blood product use, improved early indices of postoperative recovery, and attenuated indices of cytokine activation, without early adverse effects. These findings suggest that aprotinin may have unique effects in the context of neonatal cardiac surgery and challenge contentions that antifibrinolytics are equivalent with respect to early postoperative outcomes. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  20. Optimizing survival outcomes for adult patients with nontraumatic cardiac arrest [digest].

    Science.gov (United States)

    Jung, Julianna; Zaurova, Milana

    2016-10-22

    Patient survival after cardiac arrest can be improved significantly with prompt and effective resuscitative care. This systematic review analyzes the basic life support factors that improve survival outcome, including chest compression technique and rapid defibrillation of shockable rhythms. For patients who are successfully resuscitated, comprehensive postresuscitation care is essential. Targeted temperature management is recommended for all patients who remain comatose, in addition to careful monitoring of oxygenation, hemodynamics, and cardiac rhythm. Management of cardiac arrest in circumstances such as pregnancy, pulmonary embolism, opioid overdose and other toxicologic causes, hypothermia, and coronary ischemia are also reviewed. [Points & Pearls is a digest of Emergency Medicine Practice].

  1. Cardiac Arrest in Patients Managed for Convulsive Status Epilepticus: Characteristics, Predictors, and Outcome.

    Science.gov (United States)

    Legriel, Stephane; Bresson, Edouard; Deye, Nicolas; Grimaldi, David; Sauneuf, Bertrand; Lesieur, Olivier; Lascarrou, Jean-Baptiste; Argaud, Laurent; Chelly, Jonathan; Beuret, Pascal; Schnell, David; Chateauneuf, Anne-Laure; Holleville, Mathilde; Perier, François; Lemiale, Virginie; Bruel, Cedric; Cronier, Pierrick; Pichon, Nicolas; Mongardon, Nicolas; de-Prost, Nicolas; Dumas, Florence; Cariou, Alain

    2018-05-08

    Cardiac arrest is a catastrophic event that may arise during the management of convulsive status epilepticus. We aimed to report the clinical characteristics, outcomes, and early predictors of convulsive status epilepticus-related cardiac arrest. Retrospective multicenter study. Seventeen university or university affiliated participating ICUs in France and Belgium. Consecutive patients admitted to the participating ICUs for management of successfully resuscitated out-of-hospital cardiac arrest complicating the initial management of convulsive status epilepticus between 2000 and 2015. Patients were compared with controls without cardiac arrest identified in a single-center registry of convulsive status epilepticus patients, regarding characteristics, management, and outcome. None. We included 49 cases with convulsive status epilepticus-cardiac arrest and 235 controls. In the cases, median time from medical team arrival to cardiac arrest was 25 minutes (interquartile range, 5-85 min). First recorded rhythm was asystole in 25 patients (51%) and pulseless electrical activity in 13 patients (27%). A significantly larger proportion of patients had a favorable 1-year outcome (Glasgow Outcome Scale score of 5) among controls (90/235; 38%) than among cases (10/49; 21%; p = 0.02). By multivariate analysis, independent predictors of cardiac arrest were pulse oximetry less than 97% on scene (odds ratio, 2.66; 95% CI, 1.03-7.26; p = 0.04), drug poisoning as the cause of convulsive status epilepticus (odds ratio, 4.13; 95% CI, 1.27-13.53; p = 0.02), and complications during early management (odds ratio, 11.98; 95% CI, 4.67-34.69; p status epilepticus, relative hypoxemia, on-scene management complications, and drug poisoning as the cause of convulsive status epilepticus were strong early predictors of cardiac arrest, suggesting areas for improvement.

  2. A randomised controlled trial of cardiac rehabilitation after revascularisation

    NARCIS (Netherlands)

    Brugemann, Johan; Poels, Bas J. J.; Oosterwijk, Mieke H.; van der Schans, Cees P.; Postema, Klaas; van Veldhuisen, Dirk J.

    Background: It is unclear if psycho- education on top of physical training is of additional value regarding quality of life in revascularised patients. Design: Prospective randomised study comparing two types of cardiac rehabilitation: exercise based versus a more comprehensive approach including

  3. Need for Outcome Scenario Analysis of Clinical Trials in Diabetes.

    Science.gov (United States)

    Garcia-Verdugo, Rosa; Erbach, Michael; Schnell, Oliver

    2017-03-01

    Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making.

  4. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial.

    Science.gov (United States)

    Garg, Amit X; Shehata, Nadine; McGuinness, Shay; Whitlock, Richard; Fergusson, Dean; Wald, Ron; Parikh, Chirag; Bagshaw, Sean M; Khanykin, Boris; Gregory, Alex; Syed, Summer; Hare, Gregory M T; Cuerden, Meaghan S; Thorpe, Kevin E; Hall, Judith; Verma, Subodh; Roshanov, Pavel S; Sontrop, Jessica M; Mazer, C David

    2018-01-01

    When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients (~4800) undergoing planned cardiac surgery with cardiopulmonary bypass. The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery), where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

  5. Serial plasma choline measurements after cardiac arrest in patients undergoing mild therapeutic hypothermia: a prospective observational pilot trial.

    Directory of Open Access Journals (Sweden)

    Christian Storm

    Full Text Available OBJECTIVE: Choline is related to phospholipid metabolism and is a marker for global ischaemia with a small reference range in healthy volunteers. The aim of our study was to characterize the early kinetics of plasma free choline in patients after cardiac arrest. Additionally, we investigated the potential of plasma free choline to predict neurological outcome. METHODS: Twenty patients admitted to our medical intensive care unit were included in this prospective, observational trial. All patients were enrolled between May 2010 and May 2011. They received post cardiac arrest treatment including mild therapeutic hypothermia which was initiated with a combination of cold fluid and a feedback surface cooling device according to current guidelines. Sixteen blood samples per patient were analysed for plasma free choline levels within the first week after resuscitation. Choline was detected by liquid chromatography-tandem mass spectrometry. RESULTS: Most patients showed elevated choline levels on admission (median 14.8 µmol/L; interquartile range; IQR 9.9-20.1 which subsequently decreased. 48 hours after cardiac arrest choline levels in all patients reached subnormal levels at a median of 4.0 µmol/L (IQR 3-4.9; p = 0.001. Subsequently, choline levels normalized within seven days. There was no significant difference in choline levels when groups were analyzed in relation to neurological outcome. CONCLUSIONS: Our data indicate a choline deficiency in the early postresucitation phase. This could potentially result in impaired cell membrane recovery. The detailed characterization of the early choline time course may aid in planning of choline supplementation trials. In a limited number of patients, choline was not promising as a biomarker for outcome prediction.

  6. Activity and Life After Survival of a Cardiac Arrest (ALASCA and the effectiveness of an early intervention service: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bakx Wilbert GM

    2007-08-01

    Full Text Available Abstract Background Cardiac arrest survivors may experience hypoxic brain injury that results in cognitive impairments which frequently remain unrecognised. This may lead to limitations in daily activities and participation in society, a decreased quality of life for the patient, and a high strain for the caregiver. Publications about interventions directed at improving quality of life after survival of a cardiac arrest are scarce. Therefore, evidence about effective rehabilitation programmes for cardiac arrest survivors is urgently needed. This paper presents the design of the ALASCA (Activity and Life After Survival of a Cardiac Arrest trial, a randomised, controlled clinical trial to evaluate the effects of a new early intervention service for survivors of a cardiac arrest and their caregivers. Methods/design The study population comprises all people who survive two weeks after a cardiac arrest and are admitted to one of the participating hospitals in the Southern part of the Netherlands. In a two-group randomised, controlled clinical trial, half of the participants will receive an early intervention service. The early intervention service consists of several consultations with a specialised nurse for the patient and their caregiver during the first three months after the cardiac arrest. The intervention is directed at screening for cognitive problems, provision of informational, emotional and practical support, and stimulating self-management. If necessary, referral to specialised care can take place. Persons in the control group will receive the care as usual. The primary outcome measures are the extent of participation in society and quality of life of the patient one year after a cardiac arrest. Secondary outcome measures are the level of cognitive, emotional and cardiovascular impairment and daily functioning of the patient, as well as the strain for and quality of life of the caregiver. Participants and their caregivers will be followed

  7. Teamwork, communication, formula-one racing and the outcomes of cardiac surgery.

    Science.gov (United States)

    Merry, Alan F; Weller, Jennifer; Mitchell, Simon J

    2014-03-01

    Most cardiac units achieve excellent results today, but the risk of cardiac surgery is still relatively high, and avoidable harm is common. The story of the Green Lane Cardiothoracic Unit provides an exemplar of excellence, but also illustrates the challenges associated with changes over time and with increases in the size of a unit and the complexity of practice today. The ultimate aim of cardiac surgery should be the best outcomes for (often very sick) patients rather than an undue focus on the prevention of error or adverse events. Measurement is fundamental to improving quality in health care, and the framework of structure, process, and outcome is helpful in considering how best to achieve this. A combination of outcomes (including some indicators of important morbidity) with key measures of process is advocated. There is substantial evidence that failures in teamwork and communication contribute to inefficiency and avoidable harm in cardiac surgery. Minor events are as important as major ones. Six approaches to improving teamwork (and hence outcomes) in cardiac surgery are suggested. These are: 1) subspecialize and replace tribes with teams; 2) sort out the leadership while flattening the gradients of authority; 3) introduce explicit training in effective communication; 4) use checklists, briefings, and debriefings and engage in the process; 5) promote a culture of respect alongside a commitment to excellence and a focus on patients; 6) focus on the performance of the team, not on individuals.

  8. Teamwork, Communication, Formula-One Racing and the Outcomes of Cardiac Surgery

    Science.gov (United States)

    Merry, Alan F.; Weller, Jennifer; Mitchell, Simon J.

    2014-01-01

    Abstract: Most cardiac units achieve excellent results today, but the risk of cardiac surgery is still relatively high, and avoidable harm is common. The story of the Green Lane Cardiothoracic Unit provides an exemplar of excellence, but also illustrates the challenges associated with changes over time and with increases in the size of a unit and the complexity of practice today. The ultimate aim of cardiac surgery should be the best outcomes for (often very sick) patients rather than an undue focus on the prevention of error or adverse events. Measurement is fundamental to improving quality in health care, and the framework of structure, process, and outcome is helpful in considering how best to achieve this. A combination of outcomes (including some indicators of important morbidity) with key measures of process is advocated. There is substantial evidence that failures in teamwork and communication contribute to inefficiency and avoidable harm in cardiac surgery. Minor events are as important as major ones. Six approaches to improving teamwork (and hence outcomes) in cardiac surgery are suggested. These are: 1) subspecialize and replace tribes with teams; 2) sort out the leadership while flattening the gradients of authority; 3) introduce explicit training in effective communication; 4) use checklists, briefings, and debriefings and engage in the process; 5) promote a culture of respect alongside a commitment to excellence and a focus on patients; 6) focus on the performance of the team, not on individuals. PMID:24779113

  9. Role of cardiac biomarkers (troponin I and CK-MB as predictors of quality of life and long-term outcome after cardiac surgery

    Directory of Open Access Journals (Sweden)

    Bignami Elena

    2009-01-01

    Full Text Available Perioperative and postoperative morbidity and mortality associated with cardiac surgery affect both the outcome and quality of life. Markers such as troponin effectively predict short-term outcome. In a prospective cohort study in a University Hospital we assessed the role of cardiac biomarkers, also as predictors of long-term outcome and life quality after cardiac surgery with a three-year follow-up after conventional heart surgery. Patients were interviewed via phone calls with a structured questionnaire examining general health, functional status, activities of daily living, perception of life quality and need for hospital readmission. Descriptive statistics and multivariate analysis were performed. Out of 252 consecutive patients, 8 (3.2% died at the three years follow up: 7 for cardiac complications and 1 for cancer. Thirty-six patients (13.5% had hospital readmission for cardiac causes (mostly for atrial fibrillation or other arrhythmias (9.3%, but none needed cardiac surgical reintervention; 21 patients (7.9% were hospitalised for non-cardiac causes. No limitation in function activities of daily living was reported by most patients (94%, 92% perceived their general health as excellent, very good or good and none considered it insufficient; 80% were NYHA I, 17% NYHA II, 3% NYHA III and none NYHA IV. Multivariate analysis indicated preoperative treatment with digitalis or nitrates, and postoperative cardiac biomarkers release was independently associated to death. Elevated cardiac biomarker release and length of hospital stay were the only postoperative independent predictors of death in this study.

  10. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  11. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available BackgroundA pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket.MethodsIn October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device.ConclusionsPOCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  12. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial

    NARCIS (Netherlands)

    Suter, Thomas M.; Procter, Marion; van Veldhuisen, Dirk J.; Muscholl, Michael; Bergh, Jonas; Carlomagno, Chiara; Perren, Timothy; Passalacqua, Rodolfo; Bighin, Claudia; Klijn, Jan G. M.; Ageev, Fail T.; Hitre, Erika; Groetz, Juergen; Iwata, Hiroji; Knap, Malgorzata; Gnant, Michael; Muehlbauer, Susanne; Spence, Alison; Gelber, Richard D.; Piccart-Gebhart, Martine J.

    2007-01-01

    Purpose The purpose of this analysis was to investigate trastuzumab- associated cardiac adverse effects in breast cancer patients after completion of ( neo) adjuvant chemotherapy with or without radiotherapy. Patients and Methods The Herceptin Adjuvant ( HERA) trial is a three- group, multicenter,

  13. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  14. Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial.

    Science.gov (United States)

    Jacobs, Ian G; Finn, Judith C; Jelinek, George A; Oxer, Harry F; Thompson, Peter L

    2011-09-01

    There is little evidence from clinical trials that the use of adrenaline (epinephrine) in treating cardiac arrest improves survival, despite adrenaline being considered standard of care for many decades. The aim of our study was to determine the effect of adrenaline on patient survival to hospital discharge in out of hospital cardiac arrest. We conducted a double blind randomised placebo-controlled trial of adrenaline in out-of-hospital cardiac arrest. Identical study vials containing either adrenaline 1:1000 or placebo (sodium chloride 0.9%) were prepared. Patients were randomly allocated to receive 1 ml aliquots of the trial drug according to current advanced life support guidelines. Outcomes assessed included survival to hospital discharge (primary outcome), pre-hospital return of spontaneous circulation (ROSC) and neurological outcome (Cerebral Performance Category Score - CPC). A total of 4103 cardiac arrests were screened during the study period of which 601 underwent randomisation. Documentation was available for a total of 534 patients: 262 in the placebo group and 272 in the adrenaline group. Groups were well matched for baseline characteristics including age, gender and receiving bystander CPR. ROSC occurred in 22 (8.4%) of patients receiving placebo and 64 (23.5%) who received adrenaline (OR=3.4; 95% CI 2.0-5.6). Survival to hospital discharge occurred in 5 (1.9%) and 11 (4.0%) patients receiving placebo or adrenaline respectively (OR=2.2; 95% CI 0.7-6.3). All but two patients (both in the adrenaline group) had a CPC score of 1-2. Patients receiving adrenaline during cardiac arrest had no statistically significant improvement in the primary outcome of survival to hospital discharge although there was a significantly improved likelihood of achieving ROSC. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  15. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte

    2015-01-01

    , either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health...... and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210...... patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake...

  16. Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery

    DEFF Research Database (Denmark)

    Vedel, Anne G.; Holmgaard, Frederik; Rasmussen, Lars Simon

    2016-01-01

    Background: Debilitating brain injury occurs in 1.6–5 % of patients undergoing cardiac surgery with cardiopulmonary bypass. Diffusion-weighted magnetic resonance imaging studies have reported stroke-like lesions in up to 51 % of patients after cardiac surgery. The majority of the lesions seem...... to be caused by emboli, but inadequate blood flow caused by other mechanisms may increase ischaemia in the penumbra or cause watershed infarcts. During cardiopulmonary bypass, blood pressure can be below the lower limit of cerebral autoregulation. Although much debated, the constant blood flow provided...... by the cardiopulmonary bypass system is still considered by many as appropriate to avoid cerebral ischaemia despite the low blood pressure. Methods/design: The Perfusion Pressure Cerebral Infarct trial is a single-centre superiority trial with a blinded outcome assessment. The trial is randomising 210 patients...

  17. Effect of antioxidant supplementation on exercise-induced cardiac troponin release in cyclists: a randomized trial.

    Science.gov (United States)

    Klinkenberg, Lieke J J; Res, Peter T; Haenen, Guido R; Bast, Aalt; van Loon, Luc J C; van Dieijen-Visser, Marja P; Meex, Steven J R

    2013-01-01

    Cardiac troponin is the biochemical gold standard to diagnose acute myocardial infarction. Interestingly however, elevated cardiac troponin concentrations are also frequently observed during and after endurance-type exercise. Oxidative stress associated with prolonged exercise has been proposed to contribute to cardiac troponin release. Therefore, the aim of this study was to assess the effect of 4 week astaxanthin supplementation (a potent cartenoid antioxidant) on antioxidant capacity and exercise-induced cardiac troponin release in cyclists. Thirty-two well-trained male cyclists (age 25±5, weight 73±7 kg, maximum O2 uptake 60±5 mL·kg(-1)·min(-1), Wmax 5.4±0.5 W·kg(-1); mean ± SD) were repeatedly subjected to a laboratory based standardized exercise protocol before and after 4 weeks of astaxanthin (20 mg/day), or placebo supplementation in a double-blind randomized manner. Blood samples were obtained at baseline, at 60 min of cycling and immediately post-exercise (≈ 120 min). The pre-supplementation cycling trial induced a significant rise of median cardiac troponin T concentrations from 3.2 (IQR 3.0-4.2) to 4.7 ng/L (IQR 3.7-6.7), immediately post-exercise (pexercise-induced cardiac troponin T release (p = 0.24), as measured by the incremental area under the curve. Furthermore, the elevation in basal plasma astaxanthin concentrations was not reflected in changes in antioxidant capacity markers (trolox equivalent antioxidant capacity, uric acid, and malondialdehyde). Markers of inflammation (high-sensitivity C-reactive protein) and exercise-induced skeletal muscle damage (creatine kinase) were equally unaffected by astaxanthin supplementation. Despite substantial increases in plasma astaxanthin concentrations, astaxanthin supplementation did not improve antioxidant capacity in well-trained cyclists. Accordingly, exercise-induced cardiac troponin T concentrations were not affected by astaxanthin supplementation. ClinicalTrials.gov NCT01241877.

  18. Prenatally Diagnosis and Outcome of Fetuses with Cardiac Rhabdomyoma – Single Centre Experience

    Directory of Open Access Journals (Sweden)

    Ramush Bejiqi

    2017-03-01

    CONCLUSIONS: Cardiac rhabdomyoma are benign from the cardiovascular standpoint in most affected fetuses. An early prenatal diagnosis may help for an adequate planning of perinatal monitoring and treatment with the involvement of a multidisciplinary team. Large tumour size, the number of tumours and localisation may cause hydrops, and they are significantly associated with poor neonatal outcome.

  19. Outcome for Fetuses with Prenatally Detected Congenital Heart Disease and Cardiac Arrhythmias in Taiwan

    Directory of Open Access Journals (Sweden)

    Sheng-Mou Hsiao

    2007-01-01

    Conclusion: Outcome for fetuses with prenatally detected CHD remains poor, with the prognosis negatively influenced by the presence of complex heart defects as well as extracardiac and chromosomal anomalies. However, prognosis is good for fetuses with cardiac arrhythmia, except with long QT syndrome or hydrops fetalis.

  20. Bystander efforts and 1-year outcomes in out-of-hospital cardiac arrest

    DEFF Research Database (Denmark)

    Kragholm, Kristian; Wissenberg, Mads; Mortensen, Rikke N.

    2017-01-01

    changes in bystander interventions and outcomes. RESULTS Among the 2855 patients who were 30-day survivors of an out-of-hospital cardiac arrest during the period from 2001 through 2012, a total of 10.5% had brain damage or were admitted to a nursing home and 9.7% died during the 1-year follow-up period...

  1. The impact of a multidisciplinary blood conservation protocol on patient outcomes and cost after cardiac surgery.

    Science.gov (United States)

    Ad, Niv; Holmes, Sari D; Patel, Jay; Shuman, Deborah J; Massimiano, Paul S; Choi, Elmer; Fitzgerald, David; Halpin, Linda; Fornaresio, Lisa M

    2017-03-01

    Although associations between transfusion and inferior outcomes have been documented, there is a lack of blood transfusion standardization in cardiac surgery. At the Inova Heart and Vascular Institute, a multidisciplinary, criterion-driven algorithm for transfusion management was implemented. We examined the effect of our blood conservation protocol on transfusion rates and outcomes after cardiac surgery and on stability of transfusion over time. Patients undergoing first-time cardiac surgery from 2006 (full year before protocol) were compared with those in 2009 (after protocol) and propensity score matched to improve balance. Data were prospectively collected. Stability of transfusion incidence also was compared (2005-2006 vs 2008-2014). After matching, 890 patients from each year were included. Use of blood products decreased from 54% in 2006 to 25% in 2009 (P platelets (P conservation program can significantly control blood transfusion rates, improve outcomes, and be sustained over time. Efforts are needed to implement evidence-based protocols to standardize and decrease blood use in cardiac surgery to improve outcomes and reduce cost. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  2. Unstandardized treatment of electroencephalographic status epilepticus does not improve outcome of comatose patients after cardiac arrest

    NARCIS (Netherlands)

    Hofmeijer, Jeannette; Cloostermans, M.C.; Beishuizen, A.; van Putten, Michel Johannes Antonius Maria

    2014-01-01

    Objective: Electroencephalographic status epilepticus occurs in 9–35% of comatose patients after cardiac arrest. Mortality is 90–100%. It is unclear whether (some) seizure patterns represent a condition in which anti-epileptic treatment may improve outcome, or severe ischemic damage, in which

  3. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... and knowledge of HIV led to short-term trials using surrogate outcomes such as viral load and CD4 count. This established a faster drug approval process that complimented the rapid need to evaluate and provide access to drugs based on short-term trials. However, no treatment has yet been found that eradicates...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  4. Cardiac safety of citalopram: prospective trials and retrospective analyses

    DEFF Research Database (Denmark)

    Rasmussen, Søren Poul Lind; Overø, K F; Tanghøj, P

    1999-01-01

    variability of the QTc interval, as well as possible changes during treatment with placebo or citalopram, and its correlation to plasma drug levels. To document any dose-related changes, ECGs were performed at baseline and at the end of study in three randomized, double-blind, placebo- or active......-controlled, fixed-dose trials in adult and elderly patients (N = 1,460) with major depression and/or dementia. Finally, more than 6,000 ECGs (N = 1,789 citalopram-treated patients) collected from all clinical trials conducted from 1978 through 1996 were reassessed in a standardized manner to identify any effects...

  5. Risk of Acute Kidney Injury in Patients Randomized to a Restrictive Versus Liberal Approach to Red Blood Cell Transfusion in Cardiac Surgery: A Substudy Protocol of the Transfusion Requirements in Cardiac Surgery III Noninferiority Trial

    Directory of Open Access Journals (Sweden)

    Amit X. Garg

    2018-01-01

    Full Text Available Background: When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. Objective: The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Design and Setting: Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017. Patients: Patients (~4800 undergoing planned cardiac surgery with cardiopulmonary bypass. Measurements: The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery, where an acute rise is defined as ≥26.5 μmol/L in the first 48 hours after surgery or ≥50% in the first 7 days after surgery. Methods: We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m 2 . Limitations: It is not possible to blind patients or providers to the intervention; however, objective measures will be used to assess

  6. Quantifying risk and assessing outcome in cardiac surgery.

    Science.gov (United States)

    Higgins, T L

    1998-06-01

    Quality improvement, research, and reporting of outcome results can be stratified by preoperative risk by using a logistic regression equation or scores to correct for multiple risk factors. The more than 30-fold mortality differences between lowest and highest risk patients make it critical to stratify outcome results by patient severity. Probabilities are not predictions, however, and caution must be exercised when applying scores to individuals. Outcome assessment will grow in its importance to professionals, initially in the guise of quality reporting and improvement, but increasingly as a tool for risk assessment, patient counseling, and directing therapeutic decisions based on more complete information about patient subgroups. Physicians may be called on for recommendations in choosing systems for their hospitals and communities. Therefore, it is important to have an understanding of how such systems are developed, what factors indicate adequate performance of a system, and how such systems of risk stratification should be applied in practice.

  7. Maternal and fetal outcome in pregnant and parturient women with cardiac disease

    International Nuclear Information System (INIS)

    Arif, S.; Baqar, S.; Arif, A.

    2013-01-01

    Objective: To study the maternal and fetal outcome in pregnant and parturient women with cardiac disease admitted in Armed Forces Institute of Cardiology Rawalpindi. Type of Study: Cross sectional descriptive study. Place and Duration: Armed Forces Institute of Cardiology Rawalpindi Jan 2008 to June 2008. Patients and Methods: All pregnant patients beyond 28 weeks gestation with cardiac disease diagnosed before pregnancy or during the index pregnancy admitted for delivery or with cardiac complications were included in the study. All neonates less than 2.5 kg were taken as low birth weight and deliveries between 28 and 37 weeks were considered preterm. Cardiac patients with pregnancy less than 28 weeks were excluded from the study. Results: Maternal mortality was 5% with 31% mortality in NYHA Class III and IV. Perinatal mortality was 9% and low birth weight babies were 17%.Perinatal mortality was 0% in NYHA Class I and II and 60% in NYHA class III and IV. There was no maternal mortality in booked patients. All patients who expired were unbooked. Conclusion: Functional cardiac status is the most important factor affecting maternal and perinatal outcome. Antenatal booking status of the patient is the next important factor. (author)

  8. Participant-selected music and physical activity in older adults following cardiac rehabilitation: a randomized controlled trial.

    Science.gov (United States)

    Clark, Imogen N; Baker, Felicity A; Peiris, Casey L; Shoebridge, Georgie; Taylor, Nicholas F

    2017-03-01

    To evaluate effects of participant-selected music on older adults' achievement of activity levels recommended in the physical activity guidelines following cardiac rehabilitation. A parallel group randomized controlled trial with measurements at Weeks 0, 6 and 26. A multisite outpatient rehabilitation programme of a publicly funded metropolitan health service. Adults aged 60 years and older who had completed a cardiac rehabilitation programme. Experimental participants selected music to support walking with guidance from a music therapist. Control participants received usual care only. The primary outcome was the proportion of participants achieving activity levels recommended in physical activity guidelines. Secondary outcomes compared amounts of physical activity, exercise capacity, cardiac risk factors, and exercise self-efficacy. A total of 56 participants, mean age 68.2 years (SD = 6.5), were randomized to the experimental ( n = 28) and control groups ( n = 28). There were no differences between groups in proportions of participants achieving activity recommended in physical activity guidelines at Week 6 or 26. Secondary outcomes demonstrated between-group differences in male waist circumference at both measurements (Week 6 difference -2.0 cm, 95% CI -4.0 to 0; Week 26 difference -2.8 cm, 95% CI -5.4 to -0.1), and observed effect sizes favoured the experimental group for amounts of physical activity (d = 0.30), exercise capacity (d = 0.48), and blood pressure (d = -0.32). Participant-selected music did not increase the proportion of participants achieving recommended amounts of physical activity, but may have contributed to exercise-related benefits.

  9. Academic season does not influence cardiac surgical outcomes at US Academic Medical Centers.

    Science.gov (United States)

    Lapar, Damien J; Bhamidipati, Castigliano M; Mery, Carlos M; Stukenborg, George J; Lau, Christine L; Kron, Irving L; Ailawadi, Gorav

    2011-06-01

    Previous studies have demonstrated the influence of academic season on outcomes in select surgical populations. However, the influence of academic season has not been evaluated nationwide in cardiac surgery. We hypothesized that cardiac surgical outcomes were not significantly influenced by time of year at both cardiothoracic teaching hospitals and non-cardiothoracic teaching hospitals nationwide. From 2003 to 2007, a weighted 1,614,394 cardiac operations were evaluated using the Nationwide Inpatient Sample database. Patients undergoing cardiac operations at cardiothoracic teaching and non-cardiothoracic teaching hospitals were identified using the Association of American Medical College's Graduate Medical Education Tracking System. Hierarchic multivariable logistic regression analyses were used to estimate the effect of academic quarter on risk-adjusted outcomes. Mean patient age was 65.9 ± 10.9 years. Women accounted for 32.8% of patients. Isolated coronary artery bypass grafting was the most common operation performed (64.7%), followed by isolated valve replacement (19.3%). The overall incidence of operative mortality and composite postoperative complication rate were 2.9% and 27.9%, respectively. After accounting for potentially confounding risk factors, timing of operation by academic quarter did not independently increase risk-adjusted mortality (p = 0.12) or morbidity (p = 0.24) at academic medical centers. Risk-adjusted mortality and morbidity for cardiac operations were not associated with time of year in the US at teaching and nonteaching hospitals. Patients should be reassured of the safety of performance of cardiac operations at academic medical centers throughout a given academic year. Copyright © 2011 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  10. LC-REHAB: randomised trial assessing the effect of a new patient education method--learning and coping strategies--in cardiac rehabilitation.

    Science.gov (United States)

    Lynggaard, Vibeke; May, Ole; Beauchamp, Alison; Nielsen, Claus Vinther; Wittrup, Inge

    2014-12-13

    Due to improved treatments and ageing population, many countries now report increasing prevalence in rates of ischemic heart disease and heart failure. Cardiac rehabilitation has potential to reduce morbidity and mortality, but not all patients complete. In light of favourable effects of cardiac rehabilitation it is important to develop patient education methods which can enhance adherence to this effective program. The LC-REHAB study aims to compare the effect of a new patient education strategy in cardiac rehabilitation called 'learning and coping' to that of standard care. Further, this paper aims to describe the theoretical basis and details of this intervention. Open parallel randomised controlled trial conducted in three hospital units in Denmark among patients recently discharged with ischemic heart disease or heart failure. Patients are allocated to either the intervention group with learning and coping strategies incorporated into standard care in cardiac rehabilitation or the control group who receive the usual cardiac rehabilitation program. Learning and coping consists of two individual clarifying interviews, participation of experienced patients as educators together with health professionals and theory based, situated and inductive teaching. Usual care in cardiac rehabilitation is characterised by a structured deductive teaching style with use of identical pre-written slides in all hospital units. In both groups, cardiac rehabilitation consists of training three times a week and education once a week over eight weeks. The primary outcomes are adherence to cardiac rehabilitation, morbidity and mortality, while secondary outcomes are quality of life (SF-12, Health education impact questionnaire and Major Depression Inventory) and lifestyle and risk factors (Body Mass Index, waist circumference, blood pressure, exercise work capacity, lipid profile and DXA-scan). Data collection occurs four times; at baseline, at immediate completion of cardiac

  11. Examining the challenges of recruiting women into a cardiac rehabilitation clinical trial.

    Science.gov (United States)

    Beckie, Theresa M; Mendonca, Mary Ann; Fletcher, Gerald F; Schocken, Douglas D; Evans, Mary E; Banks, Steven M

    2009-01-01

    To examine the challenges of recruiting women for a 5-year cardiac rehabilitation randomized clinical trial; the aims of the study were to describe the range of recruitment sources, examine the myriad of factors contributing to ineligibility and nonparticipation of women during protocol screening, and discuss the challenges of enrolling women in the trial. The Women's-Only Phase II Cardiac Rehabilitation program used an experimental design with 2 treatment groups. Eligible participants included women who were (1) diagnosed with a myocardial infarction or stable angina or had undergone coronary revascularization within the last 12 months; (2) able to read, write, and speak English; and (3) older than 21 years. Responses to multiple recruitment strategies including automatic hospital referrals, physician office referrals, mass mailings, media advertisements, and community outreach are described. Reasons for ineligibility and nonparticipation in the trial are explored. Automatic hospital order was the largest source of referral (n = 1,367, 81%) accounting for the highest enrollment rate of women (n = 184, 73%). The barriers to enrollment into the cardiac rehabilitation clinical trial included patient-oriented, provider-oriented, and programmatic factors. Of the referral sources, 52% were screened ineligible for provider-oriented reasons, 31% were ineligible due to patient-oriented factors, and 17.4% were linked to the study protocol. Study nonparticipation of those eligible (73.8%) was largely associated with patient-oriented factors (65.2%), with far less due to provider-related factors (4%) or study-related factors (3.4%). Standing hospital orders facilitated enrollment to the cardiac rehabilitation clinical trial, yet women failed to participate predominantly due to significant patient-oriented biopsychosocial barriers.

  12. Early Head CT Findings Are Associated With Outcomes After Pediatric Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Starling, Rebecca M; Shekdar, Karuna; Licht, Dan; Nadkarni, Vinay M; Berg, Robert A; Topjian, Alexis A

    2015-07-01

    Head CT after out-of-hospital cardiac arrest is often obtained to evaluate intracranial pathology. Among children admitted to the PICU following pediatric out-of-hospital cardiac arrest, we hypothesized that loss of gray-white matter differentiation and basilar cistern and sulcal effacement are associated with mortality and unfavorable neurologic outcome. Retrospective, cohort study. Single, tertiary-care center PICU. Seventy-eight patients less than 18 years old who survived out-of-hospital cardiac arrest to PICU admission and had a head CT within 24 hours of return of spontaneous circulation were evaluated from July 2005 through May 2012. None. Median time to head CT from return of spontaneous circulation was 3.3 hours (1.0, 6.0). Median patient age was 2.3 years (0.4, 9.5). Thirty-nine patients (50%) survived, of whom 29 (74%) had favorable neurologic outcome. Nonsurvivors were more likely than survivors to have 1) loss of gray-white matter differentiation (Hounsfield unit ratios, 0.96 [0.88, 1.07] vs 1.1 [1.07, 1.2]; p pediatric out-of-hospital cardiac arrest. Select patients may have favorable outcomes despite these findings.

  13. Clinical outcomes in clinical trials of anti-HIV treatment

    DEFF Research Database (Denmark)

    Reekie, J; Mocroft, A; J, Neaton

    2007-01-01

    Since the introduction of combination antiretroviral therapy, there has been a decrease in both AIDS-defining illnesses and deaths. This decrease meant that performing clinical trials with clinical outcomes in HIV infection became more time consuming and hence costly. Improved understanding...... the infection, so when treatment is started it is currently a lifelong commitment. Is it reasonable then that guidelines are based almost completely on short-term randomized trials and observational studies of surrogate markers, or is there still a need for trials with clinical outcomes?...

  14. The efficacy of an intraoperative cell saver during cardiac surgery: a meta-analysis of randomized trials.

    Science.gov (United States)

    Wang, Guyan; Bainbridge, Daniel; Martin, Janet; Cheng, Davy

    2009-08-01

    Cell salvage may be used during cardiac surgery to avoid allogeneic blood transfusion. It has also been claimed to improve patient outcomes by removing debris from shed blood, which may increase the risk of stroke or neurocognitive dysfunction. In this study, we sought to determine the overall safety and efficacy of cell salvage in cardiac surgery by performing a systematic review and meta-analysis of published randomized controlled trials. A comprehensive search was undertaken to identify all randomized trials of cell saver use during cardiac surgery. MEDLINE, Cochrane Library, EMBASE, and abstract databases were searched up to November 2008. All randomized trials comparing cell saver use and no cell saver use in cardiac surgery and reporting at least one predefined clinical outcome were included. The random effects model was used to calculate the odds ratios (OR, 95% confidence intervals [CI]) and the weighted mean differences (WMD, 95% CI) for dichotomous and continuous variables, respectively. Thirty-one randomized trials involving 2282 patients were included in the meta-analysis. During cardiac surgery, the use of an intraoperative cell saver reduced the rate of exposure to any allogeneic blood product (OR 0.63, 95% CI: 0.43-0.94, P = 0.02) and red blood cells (OR 0.60, 95% CI: 0.39-0.92, P = 0.02) and decreased the mean volume of total allogeneic blood products transfused per patient (WMD -256 mL, 95% CI: -416 to -95 mL, P = 0.002). There was no difference in hospital mortality (OR 0.65, 95% CI: 0.25-1.68, P = 0.37), postoperative stroke or transient ischemia attack (OR 0.59, 95% CI: 0.20-1.76, P = 0.34), atrial fibrillation (OR 0.92, 95% CI: 0.69-1.23, P = 0.56), renal dysfunction (OR 0.86, 95% CI: 0.41-1.80, P = 0.70), infection (OR 1.25, 95% CI: 0.75-2.10, P = 0.39), patients requiring fresh frozen plasma (OR 1.16, 95% CI: 0.82-1.66, P = 0.40), and patients requiring platelet transfusions (OR 0.90, 95% CI: 0.63-1.28, P = 0.55) between cell saver and

  15. Modifying risks to improve outcome in cardiac surgery: An anesthesiologist's perspective

    Directory of Open Access Journals (Sweden)

    Murali Chakravarthy

    2017-01-01

    Full Text Available Challenging times are here for cardiac surgical and anesthesia team. The interventional cardiologist seem to have closed the flow of 'good cases' coming up for any of the surgery,; successful percutaneous interventions seem to be offering reasonable results in these patients, who therefore do not knock on the doors of the surgeons any more . It is a common experience among the cardiac anesthesiologists and surgeons that the type of the cases that come by now are high risk. That may be presence of comorbidities, ongoing medical therapies, unstable angina, uncontrolled heart failure and rhythm disturbances; and in patients with ischemic heart disease, the target coronaries are far from ideal. Several activities such as institution of preoperative supportive circulatory, ventilatory, and systemic disease control maneuvers seem to have helped improving the outcome of these 'high risk ' patients. This review attempts to look at various interventions and the resulting improvement in outcomes. Several changes have happened in the realm of cardiac surgery and several more are en route. At times, for want of evidence, maximal optimization may not take place and the patient may encounter unfavorable outcomes.. This review is an attempt to bring the focus of the members of the cardiac surgical team on the value of preoperative optimization of risks to improve the outcome. The cardiac surgical patients may broadly be divided into adults undergoing coronary artery bypass graft surgery, valve surgery and pediatric patients undergoing repair/ palliation of congenital heart ailments. Optimization of risks appear to be different in each genre of patients. This review also brings less often discussed issues such as anemia, nutritional issues and endocrine problems. The review is an attempt to data on ameliorating modifiable risk factors and altering non modifiable ones.

  16. Cardiac regeneration therapy: connections to cardiac physiology.

    Science.gov (United States)

    Takehara, Naofumi; Matsubara, Hiroaki

    2011-12-01

    Without heart transplantation, a large number of patients with failing hearts worldwide face poor outcomes. By means of cardiomyocyte regeneration, cardiac regeneration therapy is emerging with great promise as a means for restoring loss of cardiac function. However, the limited success of clinical trials using bone marrow-derived cells and myoblasts with heterogeneous constituents, transplanted at a wide range of cell doses, has led to disagreement on the efficacy of cell therapy. It is therefore essential to reevaluate the evidence for the efficacy of cell-based cardiac regeneration therapy, focusing on targets, materials, and methodologies. Meanwhile, the revolutionary innovation of cardiac regeneration therapy is sorely needed to help the millions of people who suffer heart failure from acquired loss of cardiomyocytes. Cardiac regeneration has been used only in limited species or as a developing process in the rodent heart; now, the possibility of cardiomyocyte turnover in the human heart is being revisited. In the pursuit of this concept, the use of cardiac stem/progenitor stem cells in the cardiac niche must be focused to usher in a second era of cardiac regeneration therapy for the severely injured heart. In addition, tissue engineering and cellular reprogramming will advance the next era of treatment that will enable current cell-based therapy to progress to "real" cardiac regeneration therapy. Although many barriers remain, the prevention of refractory heart failure through cardiac regeneration is now becoming a realistic possibility.

  17. Cardiac Myosin Binding Protein-C Autoantibodies Are Potential Early Indicators of Cardiac Dysfunction and Patient Outcome in Acute Coronary Syndrome

    Directory of Open Access Journals (Sweden)

    Thomas L. Lynch, IVPhD

    2017-04-01

    Full Text Available Summary: The degradation and release of cardiac myosin binding protein-C (cMyBP-C upon cardiac damage may stimulate an inflammatory response and autoantibody (AAb production. We determined whether the presence of cMyBP-C-AAbs associated with adverse cardiac function in cardiovascular disease patients. Importantly, cMyBP-C-AAbs were significantly detected in acute coronary syndrome patient sera upon arrival to the emergency department, particularly in ST-segment elevation myocardial infarction patients. Patients positive for cMyBP-C-AAbs had reduced left ventricular ejection fraction and elevated levels of clinical biomarkers of myocardial infarction. We conclude that cMyBP-C-AAbs may serve as early predictive indicators of deteriorating cardiac function and patient outcome in acute coronary syndrome patients prior to the infarction. Key Words: acute myocardial infarction, autoantibodies, cardiac myosin binding protein-c, cardiomyopathy

  18. Association between B vitamins supplementation and risk of cardiovascular outcomes: a cumulative meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Chi Zhang

    Full Text Available BACKGROUND: Observational studies suggest that B vitamin supplementation reduces cardiovascular risk in adults, but this association remains controversial. This study aimed to summarize the evidence from randomized controlled trials (RCTs investigating B vitamin supplementation for the primary or secondary prevention of major adverse cardiovascular outcomes and to perform a cumulative meta-analysis to determine the evidence base. METHODOLOGY AND PRINCIPAL FINDINGS: In April 2013, we searched PubMed, Embase, and the Cochrane Library to identify relevant RCTs. We included RCTs investigating the effect of B vitamin supplementation on cardiovascular outcome. Relative risk (RR was used to measure the effect using a random-effect model. Statistical heterogeneity scores were assessed using the Q statistic. We included data on 57,952 individuals from 24 RCTs: 12 primary prevention trials and 12 secondary prevention trials. In 23 of these trials, 10,917 major adverse cardiovascular events (MACE occurred; in 20 trials, 7,203 deaths occurred; in 15 trials, 3,422 cardiac deaths occurred; in 19 trials, 3,623 myocardial infarctions (MI occurred; and in 18 trials, 2,465 strokes occurred. B vitamin supplementation had little or no effect on the incidence of MACE (RR, 0.98; 95% confidence interval [CI]: 0.93-1.03; P = 0.37, total mortality (RR, 1.01; 95% CI: 0.97-1.05; P = 0.77, cardiac death (RR, 0.96; 95% CI: 0.90-1.02; P = 0.21, MI (RR, 0.99; 95% CI: 0.93-1.06; P = 0.82, or stroke (RR, 0.94; 95% CI: 0.85-1.03; P = 0.18. CONCLUSION/SIGNIFICANCE: B vitamin supplementation, when used for primary or secondary prevention, is not associated with a reduction in MACE, total mortality, cardiac death, MI, or stroke.

  19. Survivors of cardiac arrest with good neurological outcome show considerable impairments of memory functioning.

    Science.gov (United States)

    Sulzgruber, Patrick; Kliegel, Andreas; Wandaller, Cosima; Uray, Thomas; Losert, Heidrun; Laggner, Anton N; Sterz, Fritz; Kliegel, Matthias

    2015-03-01

    Deficits in cognitive function are a well-known dysfunction in survivors of cardiac arrest. However, data concerning memory function in this neurological vulnerable patient collective remain scarce and inconclusive. Therefore, we aimed to assess multiple aspects of retrospective and prospective memory performance in patients after cardiac arrest. We prospectively enrolled 33 survivors of cardiac arrest, with cerebral performance categories (CPC) 1 and 2 and a control-group (n=33) matched in sex, age and educational-level. To assess retrospective and prospective memory performance we administrated 4 weeks after cardiac arrest the "Rey Adult Learning Test" (RAVLT), the "Digit-Span-Backwards Test", the "Logic-Memory Test" and the "Red-Pencil Test". Results indicate an impairment in immediate and delayed free recall, but not in recognition. However, the overall impairment in immediate recall was qualified by analyzing RAVLT performance, showing that patients were only impaired in trials 4 and 5 of the learning sequence. Moreover, working and prospective memory as well as prose recall were worse in cardiac arrest survivors. Cranial computed tomography was available in 61% of all patients (n=20) but there was no specific neurological damage detectable that could be linked to this cognitive impairment. Episodic long-term memory functioning appears to be particularly impaired after cardiac arrest. In contrast, short-term memory storage, even tested via free-call, seems not to be affected. Based on cranial computed tomography we suggest that global brain ischemia rather than focal brain lesions appear to underlie these effects. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. Cardiac Risk Assessment, Morbidity Prediction, and Outcome in the Vascular Intensive Care Unit.

    LENUS (Irish Health Repository)

    Dover, Mary

    2013-09-17

    Objectives: The aim of this study is to examine the predictive value of the Lee revised cardiac risk index (RCRI) for a standard vascular intensive care unit (ICU) population as well as assessing the utility of transthoracic echocardiography and the impact of prior coronary artery disease (CAD) and coronary revascularization on patient outcome. Design: This is a retrospective review of prospectively maintained Vascubase and prospectively collected ICU data. Materials and Methods: Data from 363 consecutive vascular ICU admissions were collected. Findings were used to calculate the RCRI, which was then correlated with patient outcomes. All patients were on optimal medical therapy (OMT) in the form of cardioselective β-blocker, aspirin, statin, and folic acid. Results: There was no relationship found between a reduced ejection fraction and patient outcome. Mortality was significantly increased for patients with left ventricular hypertrophy (LVH) as identified on echo (14.9% vs 6.5%, P = .028). The overall complication rates were significantly elevated for patients with valvular dysfunction. Discrimination for the RCRI on receiver-operating characteristic analysis was poor, with an area under the receiver-operating characteristic curve of .621. Model calibration was reasonable with an Hosmer-Lemeshow Ĉ statistic of 2.726 (P = .256). Of those with known CAD, 41.22% of the patients receiving best medical treatment developed acute myocardial infarction (AMI) compared to 35.3% of those who previously underwent percutaneous cardiac intervention and 23.5% of those who had undergone coronary artery bypass grafting. There was 3-fold increase in major adverse clinical events in patients with troponin rise and LVH. Conclusions: The RCRI\\'s discriminatory capacity is low, and this raises difficulties in assessing cardiac risk in patients undergoing vascular intervention. The AMI is highest in the OMT group without prior cardiac intervention, which mandates protocols to

  1. The Relationship Between Preoperative Hemoglobin Concentration, Use of Hospital Resources, and Outcomes in Cardiac Surgery.

    Science.gov (United States)

    Hallward, George; Balani, Nikhail; McCorkell, Stuart; Roxburgh, James; Cornelius, Victoria

    2016-08-01

    Preoperative anemia is an established risk factor associated with adverse perioperative outcomes after cardiac surgery. However, limited information exists regarding the relationship between preoperative hemoglobin concentration and outcomes. The aim of this study was to investigate how outcomes are affected by preoperative hemoglobin concentration in a cohort of patients undergoing cardiac surgery. A retrospective, observational cohort study. A single-center tertiary referral hospital. The study comprised 1,972 adult patients undergoing elective and nonelective cardiac surgery. The independent relationship of preoperative hemoglobin concentration was explored on blood transfusion rates, return to the operating room for bleeding and/or cardiac tamponade, postoperative intensive care unit (ICU) and in-hospital length of stay, and mortality. The overall prevalence of anemia was 32% (629/1,972 patients). For every 1-unit increase in hemoglobin (g/dL), blood transfusion requirements were reduced by 11%, 8%, and 3% for red blood cell units, platelet pools, and fresh frozen plasma units, respectively (adjusted incident rate ratio 0.89 [95% CI 0.87-0.91], 0.92 [0.88-0.97], and 0.97 [0.96-0.99]). For each 1-unit increase in hemoglobin (g/dL), the probability (over time) of discharge from the ICU and hospital increased (adjusted hazard ratio estimates 1.04 [1.00-1.08] and 1.12 [1.12-1.16], respectively). A lower preoperative hemoglobin concentration resulted in increased use of hospital resources after cardiac surgery. Each g/dL unit fall in preoperative hemoglobin concentration resulted in increased blood transfusion requirements and increased postoperative ICU and hospital length of stay. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Revisiting blood transfusion and predictors of outcome in cardiac surgery patients: a concise perspective.

    Science.gov (United States)

    Arias-Morales, Carlos E; Stoicea, Nicoleta; Gonzalez-Zacarias, Alicia A; Slawski, Diana; Bhandary, Sujatha P; Saranteas, Theodosios; Kaminiotis, Eva; Papadimos, Thomas J

    2017-01-01

    In the United States, cardiac surgery-related blood transfusion rates reached new highs in 2010, with 34% of patients receiving blood products. Patients undergoing both complex (coronary artery bypass grafting [CABG] plus valve repair or replacement) and non-complex (isolated CABG) cardiac surgeries are likely to have comorbidities such as anemia. Furthermore, the majority of patients undergoing isolated CABG have a history of myocardial infarction. These characteristics may increase the risk of complications and blood transfusion requirement. It becomes difficult to demonstrate the association between transfusions and mortality because of the fact that most patients undergoing cardiac surgery are also critically ill. Transfusion rates remain high despite the advances in perioperative blood conservation, such as the intraoperative use of cell saver in cardiac surgery. Some recent prospective studies have suggested that the use of blood products, even in low-risk patients, may adversely affect clinical outcomes. In light of this information, we reviewed the literature to assess the clinical outcomes in terms of 30-day and 1-year morbidity and mortality in transfused patients who underwent uncomplicated CABG surgery.

  3. Randomized controlled trial of a psychoeducation program for the self-management of chronic cardiac pain.

    Science.gov (United States)

    McGillion, Michael H; Watt-Watson, Judy; Stevens, Bonnie; Lefort, Sandra M; Coyte, Peter; Graham, Anthony

    2008-08-01

    Cardiac pain arising from chronic stable angina (CSA) is a cardinal symptom of coronary artery disease and has a major negative impact on health-related quality of life (HRQL), including pain, poor general health status, and inability to self-manage. Current secondary prevention approaches lack adequate scope to address CSA as a multidimensional ischemic and persistent pain problem. This trial evaluated the impact of a low-cost six-week angina psychoeducation program, entitled The Chronic Angina Self-Management Program (CASMP), on HRQL, self-efficacy, and resourcefulness to self-manage anginal pain. One hundred thirty participants were randomized to the CASMP or three-month wait-list usual care; 117 completed the study. Measures were taken at baseline and three months. General HRQL was measured using the Medical Outcomes Study 36-Item Short Form and the disease-specific Seattle Angina Questionnaire (SAQ). Self-efficacy and resourcefulness were measured using the Self-Efficacy Scale and the Self-Control Schedule, respectively. The mean age of participants was 68 years, 80% were male. Analysis of variance of change scores yielded significant improvements in treatment group physical functioning [F=11.75(1,114), Phealth [F=10.94(1,114), P=0.001] aspects of generic HRQL. Angina frequency [F=5.57(1,115), P=0.02], angina stability [F=7.37(1,115), P=0.001], and self-efficacy to manage disease [F=8.45(1,115), P=0.004] were also significantly improved at three months. The CASMP did not impact resourcefulness. These data indicate that the CASMP was effective for improving physical functioning, general health, anginal pain symptoms, and self-efficacy to manage pain at three months and provide a basis for long-term evaluation of the program.

  4. A randomized controlled trial of cell salvage in routine cardiac surgery.

    Science.gov (United States)

    Klein, Andrew A; Nashef, Samer A M; Sharples, Linda; Bottrill, Fiona; Dyer, Matthew; Armstrong, Johanna; Vuylsteke, Alain

    2008-11-01

    Previous trials have indicated that cell salvage may reduce allogeneic blood transfusion during cardiac surgery, but these studies have limitations, including inconsistent use of other blood transfusion-sparing strategies. We designed a randomized controlled trial to determine whether routine cell salvage for elective uncomplicated cardiac surgery reduces blood transfusion and is cost effective in the setting of a rigorous transfusion protocol and routine administration of antifibrinolytics. Two-hundred-thirteen patients presenting for first-time coronary artery bypass grafting and/or cardiac valve surgery were prospectively randomized to control or cell salvage groups. The latter group had blood aspirate during surgery and mediastinal drainage the first 6 h after surgery processed in a cell saver device and autotransfused. All patients received tranexamic acid and were subjected to an algorithm for red blood cell and hemostatic blood factor transfusion. There was no difference between the two groups in the proportion of patients exposed to allogeneic blood (32% in both groups, relative risk 1.0 P = 0.89). At current blood products and cell saver prices, the use of cell salvage increased the costs per patient by a minimum of $103. When patients who had mediastinal re-exploration for bleeding were excluded (as planned in the protocol), significantly fewer units of allogeneic red blood cells were transfused in the cell salvage compared with the control group (65 vs 100 U, relative risk 0.71 P = 0.04). In patients undergoing routine first-time cardiac surgery in an institution with a rigorous blood conservation program, the routine use of cell salvage does not further reduce the proportion of patients exposed to allogeneic blood transfusion. However, patients who do not have excessive bleeding after surgery receive significantly fewer units of blood with cell salvage. Although the use of cell savage may reduce the demand for blood products during cardiac surgery, this

  5. Effects of Statin Treatment on Inflammation and Cardiac Function in Heart Failure: An Adjusted Indirect Comparison Meta-Analysis of Randomized Trials.

    Science.gov (United States)

    Bonsu, Kwadwo Osei; Reidpath, Daniel Diamond; Kadirvelu, Amudha

    2015-12-01

    Statins are known to prevent heart failure (HF). However, it is unclear whether statins as class or type (lipophilic or hydrophilic) improve outcomes of established HF. The current meta-analysis was performed to compare the treatment effects of lipophilic and hydrophilic statins on inflammation and cardiac function in HF. Outcomes were indicators of cardiac function [changes in left ventricular ejection fraction (LVEF) and B-type natriuretic peptide (BNP)] and inflammation [changes in highly sensitive C-reactive protein (hsCRP) and interluekin-6 (IL-6)]. We conducted a search of PubMed, EMBASE, and the Cochrane databases until December 31, 2014 for randomized control trials (RCTs) of statin versus placebo in patients with HF. RCTs with their respective extracted information were dichotomized into statin type evaluated and analyzed separately. Outcomes were pooled with random effect approach, producing standardized mean differences (SMD) for each statin type. Using these pooled estimates, we performed adjusted indirect comparisons for each outcome. Data from 6214 patients from 19 trials were analyzed. Lipophilic statin was superior to hydrophilic statin treatment regarding follow-up LVEF (SMD, 4.54; 95% CI, 4.16-4.91; P statin produces greater treatment effects on cardiac function and inflammation compared with hydrophilic statin in patients with HF. Until data from adequately powered head-to-head trial of the statin types are available, our meta-analysis brings clinicians and researchers a step closer to the quest on which statin--lipophilic or hydrophilic--is associated with better outcomes in HF. © 2015 John Wiley & Sons Ltd.

  6. The effect of Clostridium difficile infection on cardiac surgery outcomes.

    Science.gov (United States)

    Lemaire, Anthony; Dombrovskiy, Viktor; Batsides, George; Scholz, Peter; Solina, Al; Brownstone, Nicholas; Spotnitz, Alan; Lee, Leonard Y

    2015-02-01

    Clostridium difficile (CD) is a common cause of healthcare-associated infectious colitis that complicates about 1% of all hospital stays in the U.S. The impact of CD on outcomes after coronary artery bypass grafting (CABG) and valvular surgery (VS) is not well known. The Nationwide Inpatient Sample (2002-2009) was queried to identify CABG and VS patients utilizing International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes. Rates of CD, post-operative endocarditis and mediastinitis, hospital mortality rate, and resource utilization were evaluated. We identified 421,294 and 90,923 patients of age 40 yrs and older who underwent CABG and VS, respectively. The CD infection was more likely to develop in patients undergoing VS than in those having CABG (odds ratio [OR] 1.8; 95% confidence interval [CI] 1.64-1.92) and was more likely after urgent or emergency admission than after elective admission (OR 1.8; 95% CI 1.68-1.94). There was a greater likelihood of mediastinitis in patients with CD after CABG than in non-complicated cases without CD, both by univariable (OR 6.0; 95% CI 3.07-11.62) and multivariable analysis with adjustment for patient age, gender, race, type of admission, and co-morbidities (OR 3.1; 95% CI 1.49-6.51). The infection thus was most likely a result of the antibiotics used to treat mediastinitis, as the patients treated for mediastinitis were most likely to develop CD. There was a significant association in patients with CD and endocarditis who underwent VS but not in patients who did not have CD. The CD infection in these patients thus was most likely a result of the antibiotics used to treat endocarditis. Endocarditis and CD developed 3.2 times (95% CI 2.65-3.97) as often as in patients without CD, a finding that was confirmed by multivariable analysis (OR 2.2; 95% CI 1.70-2.84). At the same time, in patients having VS, there was no significant association of CD and mediastinitis. Clostridium

  7. The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Boitor, Madalina; Martorella, Géraldine; Laizner, Andréa Maria; Maheu, Christine; Gélinas, Céline

    2016-11-07

    Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown. The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery. A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016. Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done. This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population. ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http

  8. Cardiac Magnetic Resonance Imaging Predictors of Short-Term Outcomes after High Risk Coronary Surgery.

    Science.gov (United States)

    Sheriff, Mohammed J; Mouline, Omar; Hsu, Chijen; Grieve, Stuart M; Wilson, Michael K; Bannon, Paul G; Vallely, Michael P; Puranik, Rajesh

    2016-06-01

    The euroSCORE II is a widely used pre-coronary artery bypass graft surgery (CAGS) risk score, but its predictive power lacks the specificity to predict outcomes in high-risk patients (surgery case mix, revascularisation techniques and related outcomes in recent years. We investigated the utility of Cardiac Magnetic Resonance Imaging (CMRI) in predicting immediate and six-week outcomes after CAGS. Fifty-two consecutive patients with high euroSCORE II (>16) and left ventricular (LV) dysfunction (magnetic resonance imaging parameters were assessed in patients who either had complications immediately post-surgery (n=35), six weeks post-surgery (n=20) or were uncomplicated. The average age of patients recruited was 69±5 years with high euroSCORE II (22±4) and low 2D-echocardiography LV ejection fraction (38%±2%). Cardiac magnetic resonance imaging results demonstrated that those with immediate complications had higher LV scar/infarct burden as a proportion of LV mass (17±3% vs 10±3%; p=0.04) with lower circumferential relaxation index (2.5±0.46 vs 2.8±0.56; p=0.05) compared to those with no complications. Early mortality from surgery was 17% (n=9) and was associated with lower RV stroke volume (55±12 vs 68±18; p=0.03) and higher LV infarct scar/burden (18±2% vs 10±2%, p=0.04). Cardiac magnetic resonance imaging showed patients with complications at six weeks post-surgery had higher LV scar/infarct burden (14.5±2% vs 6.8±2%, p=0.03) compared to those without complications. Cardiac magnetic resonance imaging preoperative LV and RV parameters are valuable in assessing the likelihood of successful outcomes from CAGS in high-risk patients with LV dysfunction. Crown Copyright © 2016. Published by Elsevier B.V. All rights reserved.

  9. Serum uric acid level predicts adverse outcomes after myocardial revascularization or cardiac valve surgery.

    Science.gov (United States)

    Lazzeroni, Davide; Bini, Matteo; Camaiora, Umberto; Castiglioni, Paolo; Moderato, Luca; Bosi, Davide; Geroldi, Simone; Ugolotti, Pietro T; Brambilla, Lorenzo; Brambilla, Valerio; Coruzzi, Paolo

    2018-01-01

    Background High levels of serum uric acid have been associated with adverse outcomes in cardiovascular diseases such as myocardial infarction and heart failure. The aim of the current study was to evaluate the prognostic role of serum uric acid levels in patients undergoing cardiac rehabilitation after myocardial revascularization and/or cardiac valve surgery. Design We performed an observational prospective cohort study. Methods The study included 1440 patients with available serum uric acid levels, prospectively followed for 50 ± 17 months. Mean age was 67 ± 11 years; 781 patients (54%) underwent myocardial revascularization, 474 (33%) cardiac valve surgery and 185 (13%) valve-plus-coronary artery by-pass graft surgery. The primary endpoints were overall and cardiovascular mortality while secondary end-points were combined major adverse cardiac and cerebrovascular events. Results Serum uric acid level mean values were 286 ± 95 µmol/l and elevated serum uric acid levels (≥360 µmol/l or 6 mg/dl) were found in 275 patients (19%). Overall mortality (hazard ratio = 2.1; 95% confidence interval: 1.5-3.0; p uric acid levels, even after adjustment for age, gender, arterial hypertension, diabetes, glomerular filtration rate, atrial fibrillation and medical therapy. Moreover, strong positive correlations between serum uric acid level and probability of overall mortality ( p uric acid levels predict mortality and adverse cardiovascular outcome in patients undergoing myocardial revascularization and/or cardiac valve surgery even after the adjustment for age, gender, arterial hypertension, diabetes, glomerular filtration rate and medical therapy.

  10. Effect of antioxidant supplementation on exercise-induced cardiac troponin release in cyclists: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Lieke J J Klinkenberg

    Full Text Available Cardiac troponin is the biochemical gold standard to diagnose acute myocardial infarction. Interestingly however, elevated cardiac troponin concentrations are also frequently observed during and after endurance-type exercise. Oxidative stress associated with prolonged exercise has been proposed to contribute to cardiac troponin release. Therefore, the aim of this study was to assess the effect of 4 week astaxanthin supplementation (a potent cartenoid antioxidant on antioxidant capacity and exercise-induced cardiac troponin release in cyclists.Thirty-two well-trained male cyclists (age 25±5, weight 73±7 kg, maximum O2 uptake 60±5 mL·kg(-1·min(-1, Wmax 5.4±0.5 W·kg(-1; mean ± SD were repeatedly subjected to a laboratory based standardized exercise protocol before and after 4 weeks of astaxanthin (20 mg/day, or placebo supplementation in a double-blind randomized manner. Blood samples were obtained at baseline, at 60 min of cycling and immediately post-exercise (≈ 120 min.The pre-supplementation cycling trial induced a significant rise of median cardiac troponin T concentrations from 3.2 (IQR 3.0-4.2 to 4.7 ng/L (IQR 3.7-6.7, immediately post-exercise (p<0.001. Four weeks of astaxanthin supplementation significantly increased mean basal plasma astaxanthin concentrations from non-detectable values to 175±86 µg·kg(-1. However, daily astaxanthin supplementation had no effect on exercise-induced cardiac troponin T release (p = 0.24, as measured by the incremental area under the curve. Furthermore, the elevation in basal plasma astaxanthin concentrations was not reflected in changes in antioxidant capacity markers (trolox equivalent antioxidant capacity, uric acid, and malondialdehyde. Markers of inflammation (high-sensitivity C-reactive protein and exercise-induced skeletal muscle damage (creatine kinase were equally unaffected by astaxanthin supplementation.Despite substantial increases in plasma astaxanthin concentrations

  11. Outcome after resuscitation beyond 30 minutes in drowned children with cardiac arrest and hypothermia : Dutch nationwide retrospective cohort study

    NARCIS (Netherlands)

    Kieboom, J. K.; Verkade, H. J.; Burgerhof, J. G.; Bierens, J. J.; van Rheenen, P. F.; Kneyber, M. C.; Albers, M. J.

    2015-01-01

    OBJECTIVES To evaluate the outcome of drowned children with cardiac arrest and hypothermia, and to determine distinct criteria for termination of cardiopulmonary resuscitation in drowned children with hypothermia and absence of spontaneous circulation. DESIGN Nationwide retrospective cohort study.

  12. Incremental value of normal adenosine perfusion cardiac magnetic resonance: Long-term outcome.

    Science.gov (United States)

    Sozzi, Fabiola B; Iacuzio, Laura; Civaia, Filippo; Canetta, Ciro; Berthier, Frederic; Rusek, Stephane; Rossi, Philippe; Lombardi, Federico; Dreyfus, Gilles; Dor, Vincent

    2015-06-01

    The purpose of the study was to determine the long-term prognostic value of normal adenosine stress cardiac magnetic resonance imaging (CMR) in patients referred for evaluation of myocardial ischemia. We reviewed 300 consecutive patients (age 65 ± 11 years, 74% male) with suspected or known coronary disease and normal wall motion who had undergone adenosine stress CMR negative for ischemia and scar. Most patients were at intermediate risk of coronary artery disease. The end points studied were all causes of mortality and major adverse cardiac events, including cardiac death, myocardial infarction, revascularization, and hospitalization for unstable angina. During a mean follow-up of 5.5 years (mean = 5.4 ± 1.1), 16 patients died because of various causes (cardiac death in 5 patients). Three patients had a nonfatal myocardial infarction, 7 patients were hospitalized for revascularization, and 11 were medically treated for unstable angina. The annual cardiac event rate was 1.3% (0.78% in the first 3 years and 1.9% between the fourth and sixth years). The predictors of major adverse cardiac events in a multivariate analysis model were as follows: advanced age (hazard ratio [HR] 1.15, 95% confidence interval [95% CI] 1.02-1.30), diabetes (HR 17.5, 95% CI 2.2-140), and the habit of smoking (HR 5.9, 95% CI 1.0-35.5). For all causes of mortality, the only predictor was diabetes (HR 11.4, 95% CI 1.76-74.2). Patients with normal stress CMR had an excellent outcome during the 3 years after the study. The cardiac event rate was higher between the fourth and sixth years. Over a 5.5-year period, a low event rate and excellent prognosis occurred in patients with normal adenosine stress CMR. Low- to intermediate-risk patients with a normal CMR are at low risk for subsequent cardiac events. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Socioeconomic factors associated with outcome after cardiac arrest in patients under the age of 65.

    Science.gov (United States)

    Uray, Thomas; Mayr, Florian B; Fitzgibbon, James; Rittenberger, Jon C; Callaway, Clifton W; Drabek, Tomas; Fabio, Anthony; Angus, Derek C; Kochanek, Patrick M; Dezfulian, Cameron

    2015-08-01

    In a prior study of seven North American cities Pittsburgh had the highest crude rate of cardiac arrest deaths in patients 18 to 64 years of age, particularly in neighborhoods with lower socioeconomic status (SES). We hypothesized that lower SES, associated poor health behaviors (e.g., illicit drug use) and pre-existing comorbid conditions (grouped as socioeconomic factors [SE factors]) could affect the type and severity of cardiac arrest, thus outcomes. We retrospectively identified patients aged 18 to 64 years treated for in-hospital (IHCA) and out-of hospital arrest (OHCA) at two Pittsburgh hospitals between January 2010 and July 2012. We abstracted data on baseline demographics and arrest characteristics like place of residence, insurance and employment status. Favorable cerebral performance category [CPC] (1 or 2) was our primary outcome. We examined the associations between SE factors, cardiac arrest variables and outcome as well as post-resuscitation care. Among 415 subjects who met inclusion criteria, unfavorable CPC were more common in patients who were unemployed, had a history of drug abuse or hypertension. In OHCA, favorable CPC was more often associated with presentation with ventricular fibrillation/tachycardia (OR 3.53, 95% CI 1.43-8.74, p = 0.006) and less often associated with non-cardiovascular arrest etiology (OR 0.22, 95% CI 0.08-0.62, p = 0.004). We found strong associations between specific SE factors and arrest factors associated with outcome in OHCA patients only. Significant differences in post-resuscitation care existed based on injury severity, not on SES. SE factors strongly influence type and severity of OHCA but not IHCA resulting in an association with outcomes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  14. Cardiac Myosin Binding Protein-C Autoantibodies are Potential Early Indicators of Cardiac Dysfunction and Patient Outcome in Acute Coronary Syndrome.

    Science.gov (United States)

    Lynch, Thomas L; Kuster, Diederik W D; Gonzalez, Beverly; Balasubramanian, Neelam; Nair, Nandini; Day, Sharlene; Calvino, Jenna E; Tan, Yanli; Liebetrau, Christoph; Troidl, Christian; Hamm, Christian W; Güçlü, Ahmet; McDonough, Barbara; Marian, Ali J; van der Velden, Jolanda; Seidman, Christine E; Huggins, Gordon S; Sadayappan, Sakthivel

    2017-04-01

    The degradation and release of cardiac myosin binding protein-C (cMyBP-C) upon cardiac damage may stimulate an inflammatory response and autoantibody (AAb) production. We determined whether the presence of cMyBP-C-AAbs associated with adverse cardiac function in CVD patients. Importantly, cMyBP-C-AAbs were significantly detected in ACS patient sera upon arrival to the emergency department, particularly in STEMI patients. Patients positive for cMyBP-C-AAbs had a reduced LVEF and elevated levels of clinical biomarkers of MI. We conclude that cMyBP-C-AAbs may serve as early predictive indicators of deteriorating cardiac function and patient outcome in ACS patients prior to the infarction.

  15. Use of Levosimendan in Cardiac Surgery: An Update After the LEVO-CTS, CHEETAH, and LICORN Trials in the Light of Clinical Practice.

    Science.gov (United States)

    Guarracino, Fabio; Heringlake, Matthias; Cholley, Bernard; Bettex, Dominique; Bouchez, Stefaan; Lomivorotov, Vladimir V; Rajek, Angela; Kivikko, Matti; Pollesello, Piero

    2018-01-01

    Levosimendan is a calcium sensitizer and adenosine triphosphate-dependent potassium channel opener, which exerts sustained hemodynamic, symptomatic, and organ-protective effects. It is registered for the treatment of acute heart failure, and when inotropic support is considered appropriate. In the past 15 years, levosimendan has been widely used in clinical practice and has also been tested in clinical trials to stabilize at-risk patients undergoing cardiac surgery. Recently, 3 randomized, placebo-controlled, multicenter studies (LICORN, CHEETAH, and LEVO-CTS) have been published reporting on the perioperative use of levosimendan in patients with compromised cardiac ventricular function. Taken together, many smaller trials conducted in the past suggested beneficial outcomes with levosimendan in perioperative settings. By contrast, the latest 3 studies were neutral or inconclusive. To understand the reasons for such dissimilarity, a group of experts from Austria, Belgium, Finland, France, Germany, Italy, Switzerland, and Russia, including investigators from the 3 most recent studies, met to discuss the study results in the light of both the previous literature and current clinical practice. Despite the fact that the null hypothesis could not be ruled out in the recent multicenter trials, we conclude that levosimendan can still be viewed as a safe and effective inodilator in cardiac surgery.

  16. Home-based cardiac rehabilitation is as effective as centre-based cardiac rehabilitation among elderly with coronary heart disease: results from a randomised clinical trial

    DEFF Research Database (Denmark)

    Oerkild, Bodil; Frederiksen, Marianne; Hansen, Jorgen Fischer

    2011-01-01

    BACKGROUND: participation in centre-based cardiac rehabilitation (CR) is known to reduce morbidity and mortality but participation rates among the elderly are low. Establishing alternative programmes is important, and home-based CR is the predominant alternative. However, no studies have...... investigated the effect of home-based CR among a group of elderly patients with coronary heart disease with a long-term follow-up. METHODS: randomised clinical trial comparing home-based CR with comprehensive centre-based CR among patients = 65 years with coronary heart disease. RESULTS: seventy-five patients...... in the secondary outcomes of systolic blood pressure (-0.6 mmHg, 95% CI -11.3, 10.0), LDL cholesterol (0.3 mmol/l, 95% CI -0.04, 0.7), HDL cholesterol (0.2 mmol/l, 95% CI -0.01, 0.3), body composition, proportion of smokers and health-related quality of life. A group of patients who did not have an effect...

  17. Bystander Efforts and 1-Year Outcomes in Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Kragholm, Kristian; Wissenberg, Mads; Mortensen, Rikke N; Hansen, Steen M; Malta Hansen, Carolina; Thorsteinsson, Kristinn; Rajan, Shahzleen; Lippert, Freddy; Folke, Fredrik; Gislason, Gunnar; Køber, Lars; Fonager, Kirsten; Jensen, Svend E; Gerds, Thomas A; Torp-Pedersen, Christian; Rasmussen, Bodil S

    2017-05-04

    The effect of bystander interventions on long-term functional outcomes among survivors of out-of-hospital cardiac arrest has not been extensively studied. We linked nationwide data on out-of-hospital cardiac arrests in Denmark to functional outcome data and reported the 1-year risks of anoxic brain damage or nursing home admission and of death from any cause among patients who survived to day 30 after an out-of-hospital cardiac arrest. We analyzed risks according to whether bystander cardiopulmonary resuscitation (CPR) or defibrillation was performed and evaluated temporal changes in bystander interventions and outcomes. Among the 2855 patients who were 30-day survivors of an out-of-hospital cardiac arrest during the period from 2001 through 2012, a total of 10.5% had brain damage or were admitted to a nursing home and 9.7% died during the 1-year follow-up period. During the study period, among the 2084 patients who had cardiac arrests that were not witnessed by emergency medical services (EMS) personnel, the rate of bystander CPR increased from 66.7% to 80.6% (Pbystander defibrillation increased from 2.1% to 16.8% (Pbystander CPR was associated with a risk of brain damage or nursing home admission that was significantly lower than that associated with no bystander resuscitation (hazard ratio, 0.62; 95% confidence interval [CI], 0.47 to 0.82), as well as a lower risk of death from any cause (hazard ratio, 0.70; 95% CI, 0.50 to 0.99) and a lower risk of the composite end point of brain damage, nursing home admission, or death (hazard ratio, 0.67; 95% CI, 0.53 to 0.84). The risks of these outcomes were even lower among patients who received bystander defibrillation as compared with no bystander resuscitation. In our study, we found that bystander CPR and defibrillation were associated with risks of brain damage or nursing home admission and of death from any cause that were significantly lower than those associated with no bystander resuscitation. (Funded by Tryg

  18. Outcomes after out-of-hospital cardiac arrest treated by basic vs advanced life support.

    Science.gov (United States)

    Sanghavi, Prachi; Jena, Anupam B; Newhouse, Joseph P; Zaslavsky, Alan M

    2015-02-01

    Most out-of-hospital cardiac arrests receiving emergency medical services in the United States are treated by ambulance service providers trained in advanced life support (ALS), but supporting evidence for the use of ALS over basic life support (BLS) is limited. To compare the effects of BLS and ALS on outcomes after out-of-hospital cardiac arrest. Observational cohort study of a nationally representative sample of traditional Medicare beneficiaries from nonrural counties who experienced out-of-hospital cardiac arrest between January 1, 2009, and October 2, 2011, and for whom ALS or BLS ambulance services were billed to Medicare (31,292 ALS cases and 1643 BLS cases). Propensity score methods were used to compare the effects of ALS and BLS on patient survival, neurological performance, and medical spending after cardiac arrest. Survival to hospital discharge, to 30 days, and to 90 days; neurological performance; and incremental medical spending per additional survivor to 1 year. Survival to hospital discharge was greater among patients receiving BLS (13.1% vs 9.2% for ALS; 4.0 [95% CI, 2.3-5.7] percentage point difference), as was survival to 90 days (8.0% vs 5.4% for ALS; 2.6 [95% CI, 1.2-4.0] percentage point difference). Basic life support was associated with better neurological functioning among hospitalized patients (21.8% vs 44.8% with poor neurological functioning for ALS; 23.0 [95% CI, 18.6-27.4] percentage point difference). Incremental medical spending per additional survivor to 1 year for BLS relative to ALS was $154,333. Patients with out-of-hospital cardiac arrest who received BLS had higher survival at hospital discharge and at 90 days compared with those who received ALS and were less likely to experience poor neurological functioning.

  19. FIASCO II failure to achieve a satisfactory cardiac outcome study: the elimination of system errors.

    Science.gov (United States)

    Farid, Shakil; Page, Aravinda; Jenkins, David; Jones, Mark T; Freed, Darren; Nashef, Samer A M

    2013-07-01

    Death in low-risk cardiac surgical patients provides a simple and accessible method by which modifiable causes of death can be identified. In the first FIASCO study published in 2009, local potentially modifiable causes of preventable death in low-risk patients with a logistic EuroSCORE of 0-2 undergoing cardiac surgery were inadequate myocardial protection and lack of clarity in the chain of responsibility. As a result, myocardial protection was improved, and a formalized system introduced to ensure clarity of the chain of responsibility in the care of all cardiac surgical patients. The purpose of the current study was to re-audit outcomes in low-risk patients to see if improvements have been achieved. Patients with a logistic EuroSCORE of 0-2 who had cardiac surgery from January 2006 to August 2012 were included. Data were prospectively collected and retrospectively analysed. The case notes of patients who died in hospital were subject to internal and external review and classified according to preventability. Two thousand five hundred and forty-nine patients with a logistic EuroSCORE of 0-2 underwent cardiac surgery during the study period. Seven deaths occurred in truly low-risk patients, giving a mortality of 0.27%. Of the seven, three were considered preventable and four non-preventable. Mortality was marginally lower than in our previous study (0.37%), and no death occurred as a result of inadequate myocardial protection or communication failures. We postulate that the regular study of such events in all institutions may unmask systemic errors that can be remedied to prevent or reduce future occurrences. We encourage all units to use this methodology to detect any similarly modifiable factors in their practice.

  20. Outcome Measures for Clinical Trials in Down Syndrome.

    Science.gov (United States)

    Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

    2017-05-01

    Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

  1. Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wells, Adrian; McNicol, Kirsten; Reeves, David; Salmon, Peter; Davies, Linda; Heagerty, Anthony; Doherty, Patrick; McPhillips, Rebecca; Anderson, Rebecca; Faija, Cintia; Capobianco, Lora; Morley, Helen; Gaffney, Hannah; Shields, Gemma; Fisher, Peter

    2018-04-03

    Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions have not been systematically integrated into cardiac rehabilitation services despite being a strategic priority for the UK National Health Service. A promising new treatment, metacognitive therapy, may be well-suited to the needs of cardiac rehabilitation patients and has the potential to improve outcomes. It is based on the metacognitive model, which proposes that a thinking style dominated by rumination, worry and threat monitoring maintains emotional distress. Metacognitive therapy is highly effective at reducing this thinking style and alleviating anxiety and depression in mental health settings. This trial aims to evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy for cardiac rehabilitation patients with elevated anxiety and/or depressive symptoms. The PATHWAY Group-MCT trial is a multicentre, two-arm, single-blind, randomised controlled trial comparing the clinical- and cost-effectiveness of group-based metacognitive therapy plus usual cardiac rehabilitation to usual cardiac rehabilitation alone. Cardiac rehabilitation patients (target sample n = 332) with elevated anxiety and/or depressive symptoms will be recruited across five UK National Health Service Trusts. Participants randomised to the intervention arm will receive six weekly sessions of group-based metacognitive therapy delivered by either cardiac rehabilitation professionals or research nurses. The intervention and control groups will both be offered the usual cardiac rehabilitation programme within their Trust. The primary outcome is severity of anxiety and depressive symptoms at 4-month follow-up measured by the Hospital Anxiety and Depression Scale total score. Secondary outcomes are severity of anxiety/depression at 12-month follow-up, health

  2. Pravastatin But Not Simvastatin Improves Survival and Neurofunctional Outcome After Cardiac Arrest and Cardiopulmonary Resuscitation

    Directory of Open Access Journals (Sweden)

    Stefan Bergt, MD

    2017-04-01

    Full Text Available Summary: Cardiac arrest (CA followed by cardiopulmonary resuscitation (CPR is associated with high mortality and poor neurological outcome. We compared the effects of pravastatin and simvastatin on survival and neurofunction in a murine model of CA/CPR. Pravastatin, a hydrophilic statin, increased survival and neurofunction during a 28-day follow-up period. This therapy was associated with improved pulmonary function, reduced pulmonary edema, and increased endothelial cell function in vitro. In contrast, lipophilic simvastatin did not modulate survival but increased pulmonary edema and impaired endothelial cell function. Although pravastatin may display a therapeutic option for post-CA syndrome, the application of simvastatin may require re-evaluation. Key Words: cardiac arrest, endothelial cell function, ischemia and reperfusion injury, pravastatin, resuscitation, simvastatin

  3. Neurological prognostication of outcome in patients in coma after cardiac arrest.

    Science.gov (United States)

    Rossetti, Andrea O; Rabinstein, Alejandro A; Oddo, Mauro

    2016-05-01

    Management of coma after cardiac arrest has improved during the past decade, allowing an increasing proportion of patients to survive, thus prognostication has become an integral part of post-resuscitation care. Neurologists are increasingly confronted with raised expectations of next of kin and the necessity to provide early predictions of long-term prognosis. During the past decade, as technology and clinical evidence have evolved, post-cardiac arrest prognostication has moved towards a multimodal paradigm combining clinical examination with additional methods, consisting of electrophysiology, blood biomarkers, and brain imaging, to optimise prognostic accuracy. Prognostication should never be based on a single indicator; although some variables have very low false positive rates for poor outcome, multimodal assessment provides resassurance about the reliability of a prognostic estimate by offering concordant evidence. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Why persons choose to opt out of an exception from informed consent cardiac arrest trial.

    Science.gov (United States)

    Nelson, Maria J; Deiorio, Nicole M; Schmidt, Terri A; Zive, Dana M; Griffiths, Denise; Newgard, Craig D

    2013-06-01

    We sought to characterize persons who requested to opt out of an exception from informed consent (EFIC) cardiac arrest trial and their reasons for opting out. At one site of a multi-site, out-of-hospital, cardiac arrest EFIC trial (September 2007 - June 2009), persons who did not want to participate in the study could request an opt-out "NO STUDY" bracelet to prevent trial enrollment. We surveyed all persons who requested a bracelet by phone interview, web or mail. Opt-out bracelets were advertised in all public communication about the study, including community consultation and public disclosure efforts. Survey questions included demographics, Likert scale items about attitudes toward the trial and research in general, plus open-ended questions. We used descriptive statistics for standardized questions and qualitative analysis to identify common themes from open-ended questions. Sixty bracelets were requested by 50 individuals. Surveys were completed by 46 persons (92% response rate). Seventy percent of respondents agreed emergency research is important, but 87% objected to any research without consent. In the qualitative analysis, 5 overlapping themes emerged: questioning the ethics of EFIC research; concerns about how the study would impact end-of-life preferences; subjective emotions including sarcasm, anger, and allusions to past unethical research; negative reference to unrelated public health controversies; and objections to the study protocol based on misinformation. A primary reason for opting out from this EFIC trial was opposition to all research without informed consent, despite stated support for emergency research. Understanding the demographics and beliefs of persons opting out may aid researchers planning EFIC studies and help provide clarity in future EFIC-related community education efforts. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  5. Evaluation of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation: study protocol of a cluster randomized controlled trial.

    Science.gov (United States)

    Meng, Karin; Musekamp, Gunda; Seekatz, Bettina; Glatz, Johannes; Karger, Gabriele; Kiwus, Ulrich; Knoglinger, Ernst; Schubmann, Rainer; Westphal, Ronja; Faller, Hermann

    2013-08-23

    Chronic heart failure requires a complex treatment regimen on a life-long basis. Therefore, self-care/self-management is an essential part of successful treatment and comprehensive patient education is warranted. However, specific information on program features and educational strategies enhancing treatment success is lacking. This trial aims to evaluate a patient-oriented and theory-based self-management educational group program as compared to usual care education during inpatient cardiac rehabilitation in Germany. The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF patients recruited within 2 weeks after commencement of inpatient cardiac rehabilitation. Cluster randomization was chosen for pragmatic reasons, i.e. to ensure a sufficient number of eligible patients to build large-enough educational groups and to prevent contamination by interaction of patients from different treatment allocations during rehabilitation. Rehabilitants with chronic systolic heart failure (n = 540) will be consecutively recruited for the study at the beginning of inpatient rehabilitation. Data will be assessed at admission, at discharge and after 6 and 12 months using patient questionnaires. In the intervention condition, patients receive the new patient-oriented self-management educational program, whereas in the control condition, patients receive a short lecture-based educational program (usual care). The primary outcome is patients' self-reported self-management competence. Secondary outcomes include behavioral determinants and self-management health behavior (symptom monitoring, physical activity, medication adherence), health-related quality of life, and treatment satisfaction. Treatment effects will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values. This study evaluates the effectiveness of a

  6. Overall comparative analysis of management and outcomes of cardiac cases reported on board merchant ships.

    Science.gov (United States)

    Apostolatos, Charalampos; Andria, Vivian; Licari, Julie

    Telemedical assistance has always been the cornerstone of medical care on board. Significant technological progress has provided improved scientific tools and equipment for high-quality communication and prompt management of either minor incidents or major emergencies on board. Med Solutions International is a medical management company, offering services exclusively to the maritime industry. Registered vessels contact the medical team and healthcare professionals provide immediate guidelines for onboard management as well as necessary action thereafter, i.e. examination ashore or urgent medical evacuation. Since cardiac conditions or diseases are potentially the most dangerous when traveling at sea, it is of major importance to analyse and evaluate the overall management and outcomes of cases reporting symptoms of possible heart disease so as to improve telemedical assistance services in future. The study included cases reporting cardiac symptoms from 5 major shipping companies during the year 2016. Data was collected from telecommunication, emails and seafarers' final medical reports. A descriptive analysis of overall management and outcomes was performed. The study showed that the number of confirmed cardiovascular cases on board was very low. Among 551 total cases and 44 cases with reported cardiac symptoms there was only one heart attack, one pulmonary oedema and one suspected myocarditis. In the majority of cases, chest pain was musculoskeletal or due to respiratory infection. Symptoms resulting from issues such as stress or anxiety often present as potential cardiac conditions. Stress may also amplify the severity of symptoms. Language barriers between the seafarer, the master and the doctor often make communication very difficult. According to our findings there are grounds to intensify the prevention process through more efficient pre-employment medical examinations and improve management on board through more intensive training. Communication problems

  7. Development and Validation of a Model to Predict Absolute Vascular Risk Reduction by Moderate-Intensity Statin Therapy in Individual Patients With Type 2 Diabetes Mellitus: The Anglo Scandinavian Cardiac Outcomes Trial, Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, and Collaborative Atorvastatin Diabetes Study

    NARCIS (Netherlands)

    Kaasenbrood, Lotte; Poulter, Neil R.; Sever, Peter S.; Colhoun, Helen M.; Livingstone, Shona J.; Boekholdt, S. Matthijs; Pressel, Sara L.; Davis, Barry R.; van der Graaf, Yolanda; Visseren, Frank L. J.

    2016-01-01

    In this study, we aimed to translate the average relative effect of statin therapy from trial data to the individual patient with type 2 diabetes mellitus by developing and validating a model to predict individualized absolute risk reductions (ARR) of cardiovascular events. Data of 2725 patients

  8. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Dahlöf, Björn; Sever, Peter S; Poulter, Neil R

    2005-01-01

    The apparent shortfall in prevention of coronary heart disease (CHD) noted in early hypertension trials has been attributed to disadvantages of the diuretics and beta blockers used. For a given reduction in blood pressure, some suggested that newer agents would confer advantages over diuretics...

  9. Disability outcome measures in multiple sclerosis clinical trials

    DEFF Research Database (Denmark)

    Cohen, Jeffrey A; Reingold, Stephen C; Polman, Chris H

    2012-01-01

    Many of the available disability outcome measures used in clinical trials of multiple sclerosis are insensitive to change over time, inadequately validated, or insensitive to patient-perceived health status or quality of life. Increasing focus on therapies that slow or reverse disability...... recommend practical refinements. Conversely, although substantial data support the multiple sclerosis functional composite as an alternative measure, changes to its component tests and scoring method are needed. Novel approaches, including the use of composite endpoints, patient-reported outcomes...... progression makes it essential to refine existing measures or to develop new tools. Major changes to the expanded disability status scale should be avoided to prevent the loss of acceptance by regulators as a measure for primary outcomes in trials that provide substantial evidence of effectiveness. Rather, we...

  10. Goal directed fluid therapy decreases postoperative morbidity but not mortality in major non-cardiac surgery: a meta-analysis and trial sequential analysis of randomized controlled trials.

    Science.gov (United States)

    Som, Anirban; Maitra, Souvik; Bhattacharjee, Sulagna; Baidya, Dalim K

    2017-02-01

    Optimum perioperative fluid administration may improve postoperative outcome after major surgery. This meta-analysis and systematic review has been aimed to determine the effect of dynamic goal directed fluid therapy (GDFT) on postoperative morbidity and mortality in non-cardiac surgical patients. Meta-analysis of published prospective randomized controlled trials where GDFT based on non-invasive flow based hemodynamic measurement has been compared with a standard care. Data from 41 prospective randomized trials have been included in this study. Use of GDFT in major surgical patients does not decrease postoperative hospital/30-day mortality (OR 0.70, 95 % CI 0.46-1.08, p = 0.11) length of post-operative hospital stay (SMD -0.14; 95 % CI -0.28, 0.00; p = 0.05) and length of ICU stay (SMD -0.12; 95 % CI -0.28, 0.04; p = 0.14). However, number of patients having at least one postoperative complication is significantly lower with use of GDFT (OR 0.57; 95 % CI 0.43, 0.75; p infection (p = 0.002) and postoperative hypotension (p = 0.04) are also decreased with used of GDFT as opposed to a standard care. Though patients who received GDFT were infused more colloid (p infection, abdominal complications and postoperative hypotension is reduced.

  11. [Reliability of nursing outcomes classification label "Knowledge: cardiac disease management (1830)" in outpatients with heart failure].

    Science.gov (United States)

    Cañón-Montañez, Wilson; Oróstegui-Arenas, Myriam

    2015-01-01

    To determine the reliability (internal consistency, inter-rater reproducibility and level of agreement) of nursing outcome: "Knowledge: cardiac disease management (1830)" of the version published in Spanish, in outpatients with heart failure. A reliability study was conducted on 116 outpatients with heart failure. Six indicators of nursing outcome were operationalized. All participants were assessed simultaneously by two evaluators. Three evaluation periods were defined: initial (at baseline), final (a month later), and follow-up (two months later). Internal consistency by Cronbach alpha coefficient, inter-rater reproducibility with intraclass correlation coefficient of reproducibility or agreement and level agreement using the 95% limits of Bland and Altman. Cronbach's alpha was 0.83 (95% CI: 0.77 - 0.89) in the final evaluation, and follow-up values of 0.85 (95% CI: 0.82-0.89) and 0.83 (95% CI: 0.78 - 0.88) were found for the first and second evaluator, respectively. The intraclass correlation coefficient showed values greater 0.9 in the three evaluation periods in both the random and mixed model. The Bland-Altman 95% limits of agreement were close to zero in the three evaluations performed. The questionnaire operationalized to assess the nursing outcome: "Knowledge: cardiac disease management (1830)" in its Spanish version, is a reliable method to measure skills and knowledge in outpatients with heart failure in the Colombian context. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  12. Hypothermia after cardiac arrest should be further evaluated-A systematic review of randomised trials with meta-analysis and trial sequential analysis

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Friberg, Hans; Gluud, Christian

    2011-01-01

    BACKGROUND: Guidelines recommend mild induced hypothermia (MIH) to reduce mortality and neurological impairment after out-of-hospital cardiac arrest. Our objective was to systematically evaluate the evidence for MIH taking into consideration the risks of systematic and random error and to GRADE...... the evidence. METHODS: Systematic review with meta-analysis and trial sequential analysis of randomised trials evaluating MIH after cardiac arrest in adults. We searched CENTRAL, MEDLINE, and EMBASE databases until May 2009. Retrieved trials were evaluated with Cochrane methodology. Meta-analytic estimates....... The substantial risk of bias and concerns with directness rated down the quality of the evidence to low. CONCLUSIONS: Evidence regarding MIH after out-of-hospital cardiac arrest is still inconclusive and associated with non-negligible risks of systematic and random errors. Using GRADE-methodology, we conclude...

  13. [Cardiac myxoma -- the influence of preoperative clinical presentation and surgical technique on late outcome].

    Science.gov (United States)

    Mikić, Aleksandar; Obrenović-Krcanski, Bilijana; Kocica, Mladen; Vranes, Mile; Lacković, Vesna; Velinović, Milos; Miarković, Miroslav; Kovacević, Natasa; Djukić, Petar

    2007-01-01

    Cardiac myxomas are the most frequent primary tumours of the heart in adults, and they can be found in each of four cardiac chambers. Although biologically benign, due to their unfavourable localization, myxomas are considered "functionally malignant" tumours. Diagnosis of cardiac myxoma necessitates surgical treatment. To analyse: 1) the influence of localization, size and consistency of cardiac myxomas on preoperative symptomatology; 2) the influence of different surgical techniques (left, right, biatrial approach, tumour basis solving) on early, and late outcomes. From 1982 to 2000, at the Institute for Cardiovascular Diseases, Clinical Centre of Serbia, there were 46 patients with cardiac myxomas operated on, 67.4% of them women, mean age 47.1 +/- 16.3 years. The diagnosis was made according to clinical presentation, electrocardiographic and echocardiographic examinations and cardiac catheterization. Follow-up period was 4-18 (mean 7.8) years. In 41 (89.1%) patients, myxoma was localized in the left, while in 5 (10.9%), it was found in the right atrium. Average size was 5.8 x 3.8 cm (range: 1 x l cm to 9 x 8 cm) and 6 x 4 cm (range: 3 x 2 cm to 9 x 5 cm) for the left and right atrial myxomas, respectively. A racemous form predominated in the left (82.6%) and globous in the right (80%) atrium. Fatigue was the most common general (84.8%) and dyspnoea the most common cardiologic symptom (73.9%). Preoperative embolic events were present in 8 patients (4 pulmonary, 4 systemic). In our series: 1) different localization, size and consistency had no influence on the preoperative symptomatology; 2) surgical treatment applied, regardless of different approaches and basis solving, resulted in excellent functional improvements (63.1% patients in NYHA III and IV class preoperatively vs. 6.7% patients postoperatively) and had no influence on new postoperative rhythm disturbances (8.7% patients preoperatively vs. 24.4% patients postoperatively); 3) early (97.8%), and late

  14. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Sever, Peter S; Dahlöf, Björn; Poulter, Neil R

    2003-01-01

    The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study, however, has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (CHD) in hypertensive patients who are not conventionally deemed ...

  15. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial

    DEFF Research Database (Denmark)

    Sever, Peter S; Dahlöf, Björn; Poulter, Neil R

    2004-01-01

    The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study, however, has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (CHD) in hypertensive patients who are not conventionally deemed ...

  16. Introduction of universal prestorage leukodepletion of blood components, and outcomes in transfused cardiac surgery patients.

    Science.gov (United States)

    McQuilten, Zoe K; Andrianopoulos, Nick; van de Watering, Leo; Aubron, Cecile; Phillips, Louise; Bellomo, Rinaldo; Pilcher, David; Cameron, Peter; Reid, Christopher M; Cole-Sinclair, Merrole F; Newcomb, Andrew; Smith, Julian; McNeil, John J; Wood, Erica M

    2015-07-01

    To assess whether introduction of universal leukodepletion (ULD) of red blood cells (RBCs) for transfusion was associated with improvements in cardiac surgery patient outcomes. Retrospective study (2005-2010) conducted at 6 institutions. Associations between leukodepletion and outcomes of mortality, infection, and acute kidney injury (AKI) were modeled by logistic regression, and intensive care unit length of stay (LOS) in survivors was explored using linear regression. To examine trends over time, odds ratios (ORs) for outcomes of transfused were compared with nontransfused patients, including a comparison with nontransfused patients who were selected based on propensity score for RBC transfusion. We studied 14,980 patients, of whom 8857 (59%) had surgery pre-ULD. Transfusions of RBCs were made in 3799 (43%) pre-ULD, and 2525 (41%) post-ULD. Administration of exclusively leukodepleted, versus exclusively nonleukodepleted, RBCs was associated with lower incidence of AKI (adjusted OR 0.80, 95% confidence interval [CI] 0.65-0.98, P = .035), but no difference in mortality or infection. For post-ULD patients, no difference was found in mortality (OR 0.96, 95% CI 0.76-1.22, P = .76) or infection (OR 0.91, 95% CI 0.79-1.03, P = .161); however, AKI was reduced (OR 0.79 95% CI 0.68-0.92, P = .003). However, ORs for post-ULD outcomes were not significantly different in nontransfused, versus transfused, patients. Furthermore, those who received exclusively nonleukodepleted RBCs were more likely to have surgery post-ULD. Universal leukodepletion was not associated with reduced mortality or infection in transfused cardiac surgery patients. An association was found between ULD and reduced AKI; however, this reduction was not significantly different from that seen in nontransfused patients, and other changes in care most likely explain such changes in renal outcomes. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  17. Are lower levels of red blood cell transfusion more cost-effective than liberal levels after cardiac surgery? Findings from the TITRe2 randomised controlled trial

    Science.gov (United States)

    Stokes, E A; Wordsworth, S; Bargo, D; Pike, K; Rogers, C A; Brierley, R C M; Angelini, G D; Murphy, G J; Reeves, B C

    2016-01-01

    Objective To assess the incremental cost and cost-effectiveness of a restrictive versus a liberal red blood cell transfusion threshold after cardiac surgery. Design A within-trial cost-effectiveness analysis with a 3-month time horizon, based on a multicentre superiority randomised controlled trial from the perspective of the National Health Service (NHS) and personal social services in the UK. Setting 17 specialist cardiac surgery centres in UK NHS hospitals. Participants 2003 patients aged >16 years undergoing non-emergency cardiac surgery with a postoperative haemoglobin of threshold during hospitalisation after surgery. Main outcome measures Health-related quality of life measured using the EQ-5D-3L to calculate quality-adjusted life years (QALYs). Results The total costs from surgery up to 3 months were £17 945 and £18 127 in the restrictive and liberal groups (mean difference is −£182, 95% CI −£1108 to £744). The cost difference was largely attributable to the difference in the cost of red blood cells. Mean QALYs to 3 months were 0.18 in both groups (restrictive minus liberal difference is 0.0004, 95% CI −0.0037 to 0.0045). The point estimate for the base-case cost-effectiveness analysis suggested that the restrictive group was slightly more effective and slightly less costly than the liberal group and, therefore, cost-effective. However, there is great uncertainty around these results partly due to the negligible differences in QALYs gained. Conclusions We conclude that there is no clear difference in the cost-effectiveness of restrictive and liberal thresholds for red blood cell transfusion after cardiac surgery. Trial registration number ISRCTN70923932; Results. PMID:27481621

  18. Factors influencing the outcome of paediatric cardiac surgical patients during extracorporeal circulatory support

    Directory of Open Access Journals (Sweden)

    Peek Giles J

    2007-01-01

    Full Text Available Abstract Background Veno-arterial extracorporeal membrane oxygenation (ECMO is a common modality of circulatory assist device used in children. We assessed the outcome of children who had ECMO following repair of congenital cardiac defects (CCD and identified the risk factors associated with hospital mortality. Methods From April 1990 to December 2003, 53 patients required ECMO following surgical correction of CCD. Retrospectively collected data was analyzed with univariate and multivariate logistic regression analysis. Results Median age and weight of the patients were 150 days and 5.4 kgs respectively. The indications for ECMO were low cardiac output in 16, failure to wean cardiopulmonary bypass in 13, cardiac arrest in 10 and cardio-respiratory failure in 14 patients. The mean duration of ECMO was 143 hours. Weaning off from ECMO was successful in 66% and of these 83% were survival to hospital-discharge. 37.7% of patients were alive for the mean follow-up period of 75 months. On univariate analysis, arrhythmias, ECMO duration >168 hours, bleeding complications, renal replacement therapy on ECMO, arrhythmias and cardiac arrest after ECMO were associated with hospital mortality. On multivariate analysis, abnormal neurology, bleeding complications and arrhythmias after ECMO were associated with hospital mortality. Extra and intra-thoracic cannulations were used in 79% and 21% of patients respectively and extra-thoracic cannulation had significantly less bleeding complications (p = 0.031. Conclusion ECMO provides an effective circulatory support following surgical repair of CCD in children. Extra-thoracic cannulation is associated with less bleeding complications. Abnormal neurology, bleeding complications on ECMO and arrhythmias after ECMO are poor prognostic indicators for hospital survival.

  19. Audit of Cardiac Surgery Outcomes for Low Birth Weight and Premature Infants.

    Science.gov (United States)

    Alarcon Manchego, Peter; Cheung, Michael; Zannino, Diana; Nunn, Russell; D'Udekem, Yves; Brizard, Christian

    2018-01-01

    The burden of disease associated with cardiac surgery in preterm and low birth weight infants is increasing. This retrospective study aimed to compare the mortality and morbidity of cardiac surgery in low birth weight and preterm infants with that of a case-matched normal population. This was a single-center audit of cardiac surgery interventions at a tertiary pediatric center in Melbourne, Australia. Subjects underwent intervention in the first 3 months of life and were preterm (<37 weeks' gestation) or <2500 g at birth. Subjects were case-matched with 2 controls of term gestation and appropriate birth weight with the same primary diagnosis and intervention. Principal outcomes were mortality and complications in the 6 months following intervention. A total of 513 participants were included for analysis in the 13-year study period. There was an increased risk of mortality (odds ratio 6.26; 95% confidence interval (3.19, 12.3)) and rate of complications (odds ratio 2.29; 95% confidence interval (1.38, 3.78)) in low birth weight and premature infants compared with the control population. Patients who did not survive were more likely to have required extracorporeal membrane oxygenation (relative risk [RR] 6.6, P < 0.001), developed postoperative sepsis (RR 2.6, P = 0.012), and undergone unplanned reintervention (RR 2.3, P < 0.001) compared with survivors. Preterm and low birth weight patients had twice the RR of developing complications and 6 times the risk of mortality in the 6 months following cardiac intervention compared with a matched population. Observed trends suggest delaying surgery in clinically stable infants beyond 35 weeks corrected gestational age and 2500-g weight may result in improved survival. Copyright © 2018 Elsevier Inc. All rights reserved.

  20. Prolonged Cardiac Monitoring to Detect Atrial Fibrillation after Cryptogenic Stroke or Transient Ischemic Attack: A Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Dahal, Khagendra; Chapagain, Bikas; Maharjan, Raju; Farah, Hussam W; Nazeer, Ayesha; Lootens, Robert J; Rosenfeld, Alan

    2016-07-01

    The cause of ischemic stroke or transient ischemic attack (TIA) remains unclear after initial cardiac monitoring in approximately one-third of patients. Randomized controlled trials (RCTs) showed that the prolonged cardiac monitoring of patients with cryptogenic stroke or TIA increased detection of atrial fibrillation (AF). We aimed to perform a meta-analysis of all RCTs that evaluated the prolonged monitoring ≥7 days in patients with cryptogenic stroke or TIA. We searched PubMed, EMBASE, Cochrane CENTRAL, and relevant references for RCTs without language restriction (inception through December 2014) and performed meta-analysis using random effects model. Detection of AF, use of anticoagulation at follow-up, recurrent stroke or TIA, and mortality were major outcomes. Four RCTs with 1149 total patients were included in the meta-analysis. Prolonged cardiac monitoring ≥7 days compared to shorter cardiac monitoring of ≤48 hours duration increased the detection of AF (≥30 seconds duration) in patients after cryptogenic stroke or TIA (13.8% vs. 2.5%; odds ratio [OR], 6.4; 95% confidence interval [CI], 3.50-11.73; P vs. 5.2%; 5.68[3.3-9.77]; P stroke or TIA (0.78[0.40-1.55]; P = 0.48; I(2) , 0%) and mortality (1.33[0.29-6.00]; P = 0.71; I(2) , 0%] were observed between two strategies. Prolonged cardiac monitoring improves detection of atrial fibrillation and anti-coagulation use after cryptogenic stroke or TIA and therefore should be considered instead of shorter duration of cardiac monitoring. © 2015 Wiley Periodicals, Inc.

  1. A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department.

    Science.gov (United States)

    Ong, Marcus Eng Hock; Tiah, Ling; Leong, Benjamin Sieu-Hon; Tan, Elaine Ching Ching; Ong, Victor Yeok Kein; Tan, Elizabeth Ai Theng; Poh, Bee Yen; Pek, Pin Pin; Chen, Yuming

    2012-08-01

    To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department (ED). A randomised, double-blind, multi-centre, parallel-design clinical trial in four adult hospitals. Eligible cardiac arrest patients (confirmed by the absence of pulse, unresponsiveness and apnea) aged >16 (aged>21 for one hospital) were randomly assigned to intravenous adrenaline (1mg) or vasopressin (40 IU) at ED. Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation (CPR) were excluded. Patients received additional open label doses of adrenaline as per current guidelines. Primary outcome was survival to hospital discharge (defined as participant discharged alive or survival to 30 days post-arrest). The study recruited 727 participants (adrenaline = 353; vasopressin = 374). Baseline characteristics of the two groups were comparable. Eight participants (2.3%) from adrenaline and 11 (2.9%) from vasopressin group survived to hospital discharge with no significant difference between groups (p = 0.27, RR = 1.72, 95% CI = 0.65-4.51). After adjustment for race, medical history, bystander CPR and prior adrenaline given, more participants survived to hospital admission with vasopressin (22.2%) than with adrenaline (16.7%) (p = 0.05, RR = 1.43, 95% CI = 1.02-2.04). Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times. Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest. Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  2. Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial.

    Science.gov (United States)

    Lockwood, Geoff G; Cabreros, Leilani; Banach, Dorota; Punjabi, Prakash P

    2017-10-01

    Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg -1 .hr -1 ) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l -1 . There were no adverse events as a consequence of the study. Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. ISRCTN13424423 ( https://www.isrctn.com ).

  3. Prenatally Diagnosis and Outcome of Fetuses with Cardiac Rhabdomyoma – Single Centre Experience

    Science.gov (United States)

    Bejiqi, Ramush; Retkoceri, Ragip; Bejiqi, Hana

    2017-01-01

    BACKGROUND Cardiac rhabdomyoma (CRs) are the most common primary tumour of the heart in infants and children. Usually are multiple and, basing on the location can cause a haemodynamic disturbance, dysrhythmias or heart failure during the fetal and early postnatal period. CRs have a natural history of spontaneous regression and are closely associated with tuberous sclerosis complex (TSC). It has an association with tuberous sclerosis (TS), and in those, the tumour may regress and disappear completely, or remain consistent in size. AIM: We aimed to evaluate the prenatal diagnosis, clinical presentation and outcome of CRs and their association with TSC in a single centre. The median follow-up period was three years (range: 6 months - 5 years). MATERIAL AND METHODS: We reviewed medical records of all fetuses diagnosed prenatally with cardiac rhabdomyoma covering the period January 2010 to December 2016 which had undergone detailed ultrasound evaluation at a single centre with limited technical resources. RESULTS: Twelve fetuses were included in the study; mostly had multiple tumours and a total of 53 tumours were identified in all patients - the maximum was one fetus with16 tumours. All patients were diagnosed prenatally by fetal echocardiography. In two patient’s haemodynamic disturbances during the fetal period was noted and pregnancies have been terminated. After long consultation termination of pregnancy was chosen by the parents in totally 8 cases. In four continuing pregnancies during the first year of live tumours regressed. TSC was diagnosed in all patients during the follow-up. CONCLUSIONS: Cardiac rhabdomyoma are benign from the cardiovascular standpoint in most affected fetuses. An early prenatal diagnosis may help for an adequate planning of perinatal monitoring and treatment with the involvement of a multidisciplinary team. Large tumour size, the number of tumours and localisation may cause hydrops, and they are significantly associated with poor

  4. Ambulance cardiopulmonary resuscitation: outcomes and associated factors in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Rosell Ortiz, Fernando; García Del Águila, Javier; Fernández Del Valle, Patricia; J Mellado-Vergel, Francisco; Vergara-Pérez, Santiago; R Ruiz-Montero, María; Martínez-Lara, Manuela; J Gómez-Jiménez, Francisco; Gonzáez-Lobato, Ismael; García-Escudero, Guillermo; Ruiz-Bailén, Manuel; Caballero-García, Auxiliadora; Vivar-Díaz, Itziar; Olavarría-Govantes, Luis

    2018-06-01

    To assess factors associated with survival of out-of-hospital cardiac arrest (OHCA) in patients who underwent cardiopulmonary resuscitation (CPR) during ambulance transport. Retrospective analysis of a registry of OHCA cases treated between 2008 and 2014. We included patients who had not recovered circulation at the time it was decided to transport to a hospital and who were rejected as non-heart-beating donors. Multivariate analysis was used to explore factors associated with the use of ambulance CPR, survival, and neurologic outcome. Out of a total of 7241 cases, 259 (3.6%) were given CPR during emergency transport. The mean (SD) age was 51.6 (23.6) years; 27 (10.1%) were aged 16 years or younger. The following variables were associated with the use of CPR during transport: age 16 years or under (odds ratio [OR], 6.48; 95% CI, 3.91-10.76); P<.001)], witnessed OHCA (OR, 1.62; 95% CI, 1.16-2.26; P=.004), cardiac arrest outside the home (OR, 3.17; 95% CI, 2.38-4.21; P<.001), noncardiac cause (OR, 1.47; 95% CI, 1.07-2.02; P=.019], initially shockable rhythm (OR, 1.67; 95% CI, 1.17-2.37; P=.004), no prior basic life support (OR, 3.48; 95% CI, 2.58-4.70; P<.001), and orotracheal intubation (OR, 1.93; 95% CI, 1.24-2.99; P=.003). One patient (0.38%) survived to discharge with good neurologic outcome. Ambulance CPR by a physician on board is applied in few OHCA cases. Young patient age, cardiac arrest outside the home, the presence of a witness, lack of a shockable rhythm on responder arrival, lack of basic life support prior to responder arrival, noncardiac cause, and orotracheal intubation are associated with the use of ambulance CPR, a strategy that can be considered futile.

  5. Improving outcomes from out-of-hospital cardiac arrest in young children and adolescents.

    Science.gov (United States)

    Atkins, Dianne L; Berger, Stuart

    2012-03-01

    Out-of-hospital cardiac arrest (OHCA) is an unusual but devastating occurrence in a young person. Years of life-lost are substantial and long-term health care costs of survivors can be high. However, there have been noteworthy improvements in cardiopulmonary resuscitation (CPR) standards, out-of hospital care, and postcardiac arrest therapies that have resulted in a several-fold improvement in resuscitation outcomes. Recent interest and research in resuscitation of children has the promise of generating improvements in the outcomes of these patients. Integrated and coordinated care in the out-of-hospital and hospital settings are required. This article will review the epidemiology of OHCA, the 2010 CPR guidelines, and developments in public access defibrillation for children.

  6. Resuscitation outcomes of reproductive-age females who experienced out-of-hospital cardiac arrest.

    Science.gov (United States)

    Hagihara, Akihito; Onozuka, Daisuke; Hasegawa, Manabu; Nagata, Takashi; Abe, Takeru; Nabeshima, Yoshihiro

    2017-03-01

    Although some studies have shown that women in their reproductive years have better resuscitation outcomes of out-of-hospital cardiac arrest (OHCA), conflicting results and methodological problems have also been noted. Thus, we evaluated the resuscitation outcomes of OHCA of females by age. This was a prospective observational study using registry data from all OHCA cases between 2005 and 2012 in Japan. The subjects were females aged 18-110 years who suffered an out-of-hospital cardiac arrest. Logistic regression analyses were performed using total and propensity-matched patients. There were 381,123 OHCA cases that met the inclusion criteria. Among propensity-matched patients, females aged 18-49 and 50-60 years of age had similar rates of return of spontaneous circulation before hospital arrival and 1-month survival (all p>0.60). In contrast, females aged 18-49 years of age had significantly lower rates of 1-month survival with minimal neurological impairment than did females aged 50-60 years of age (after adjusting for selected variables: Cerebral Performance Category scale 1 or 2 (CPC (1, 2)), OR=0.45, p=0.020; Overall Performance Category scale 1 or 2 (OPC (1, 2)): OR=0.42, p= 0.014; after adjustment for all variables: CPC (1, 2), OR=0.27, p= 0.008; OPC (1, 2), OR=0.29, p=0.009). Women of reproductive age did not show improved resuscitation outcomes in OHCA. Additionally, women in their reproductive years showed worse neurological outcomes one month after the event, which may be explained by the negative effects of estrogen. These findings need to be verified in further studies.

  7. Effects of Age on Outcome in the SENTIS Trial : Better Outcomes in Elderly Patients

    NARCIS (Netherlands)

    Leker, Ronen R.; Molina, Carlos; Cockroft, Kevin; Liebeskind, David S.; Concha, Mauricio; Shuaib, Ashfaq; De Deyn, Peter Paul; Burgin, W. Scott; Gupta, Rishi; Dillon, William; Diener, Hans-Christoph

    2012-01-01

    Background: Increasing age is associated with poor outcome after stroke. The Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) trial explored the augmentation of collateral circulation to the ischemic penumbra as a novel approach to stroke treatment. The aim of this post hoc

  8. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  9. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  10. No Benefit in Neurologic Outcomes of Survivors of Out-of-Hospital Cardiac Arrest with Mechanical Compression Device.

    Science.gov (United States)

    Newberry, Ryan; Redman, Ted; Ross, Elliot; Ely, Rachel; Saidler, Clayton; Arana, Allyson; Wampler, David; Miramontes, David

    2018-01-01

    Out-of-hospital cardiac arrest (OHCA) is a major cause of death and morbidity in the United States. Quality cardiopulmonary resuscitation (CPR) has proven to be a key factor in improving survival. The aim of our study was to investigate the outcomes of OHCA when mechanical CPR (LUCAS 2 Chest Compression System™) was utilized compared to conventional CPR. Although controlled trials have not demonstrated a survival benefit to the routine use of mechanical CPR devices, there continues to be an interest for their use in OHCA. We conducted a retrospective observational study of OHCA comparing the outcomes of mechanical and manual chest compressions in a fire department based EMS system serving a population of 1.4 million residents. Mechanical CPR devices were geographically distributed on 11 of 33 paramedic ambulances. Data were collected over a 36-month period and outcomes were dichotomized based on utilization of mechanical CPR. The primary outcome measure was survival to hospital discharge with a cerebral performance category (CPC) score of 1 or 2. This series had 3,469 OHCA reports, of which 2,999 had outcome data and met the inclusion criteria. Of these 2,236 received only manual CPR and 763 utilized a mechanical CPR device during the resuscitation. Return of spontaneous circulation (ROSC) was attained in 44% (334/763) of the mechanical CPR resuscitations and in 46% (1,020/2,236) of the standard manual CPR resuscitations (p = 0.32). Survival to hospital discharge was observed in 7% (52/763) of the mechanical CPR resuscitations and 9% (191/2,236) of the manual CPR group (p = 0.13). Discharge with a CPC score of 1 or 2 was observed in 4% (29/763) of the mechanical CPR resuscitation group and 6% (129/2,236) of the manual CPR group (p = 0.036). In our study, use of the mechanical CPR device was associated with a poor neurologic outcome at hospital discharge. However, this difference was no longer evident after logistic regression adjusting for confounding variables

  11. Use of outcome measures in pulmonary hypertension clinical trials.

    Science.gov (United States)

    Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

    2015-09-01

    To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or stable use of imaging and invasive measures. In contrast, imaging and invasive measures are commonly used in contemporary clinical practice. Further research is needed to validate and standardize currently used measures. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Closing the knowledge gap on cardiovascular disease in type 2 diabetes: the EMPA-REG OUTCOME trial and beyond

    Directory of Open Access Journals (Sweden)

    Elif A Oral

    2016-09-01

    Full Text Available Type 2 diabetes mellitus (T2DM is associated with marked cardiovascular (CV morbidity and mortality, including heartfailure (HF. Until recently, an oral glucose-lowering agent that improved hyperglycemia as well as provided CV benefits in patients with T2DM and cardiovascular disease (CVD was lacking. The newest class of glucose-lowering agents, sodium glucose cotransporter 2 (SGLT2 inhibitors, includes canagliflozin, dapagliflozin, and empagliflozin. Prior to the release of the LEADER trial results, the recent EMPA-REG OUTCOME study was the only dedicated CV trial to demonstrate a reduction in major adverse cardiac events, CV mortality, and all-cause mortality and a reduction in hospitalization for HF with empagliflozin, given on top of standard-of-care therapy in patients with T2DM and CVD. This paper summarizes the results from EMPA-REG OUTCOME and discusses their significance and clinical implications.

  13. Electroencephalography Predicts Poor and Good Outcomes After Cardiac Arrest: A Two-Center Study.

    Science.gov (United States)

    Rossetti, Andrea O; Tovar Quiroga, Diego F; Juan, Elsa; Novy, Jan; White, Roger D; Ben-Hamouda, Nawfel; Britton, Jeffrey W; Oddo, Mauro; Rabinstein, Alejandro A

    2017-07-01

    The prognostic role of electroencephalography during and after targeted temperature management in postcardiac arrest patients, relatively to other predictors, is incompletely known. We assessed performances of electroencephalography during and after targeted temperature management toward good and poor outcomes, along with other recognized predictors. Cohort study (April 2009 to March 2016). Two academic hospitals (Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Mayo Clinic, Rochester, MN). Consecutive comatose adults admitted after cardiac arrest, identified through prospective registries. All patients were managed with targeted temperature management, receiving prespecified standardized clinical, neurophysiologic (particularly, electroencephalography during and after targeted temperature management), and biochemical evaluations. We assessed electroencephalography variables (reactivity, continuity, epileptiform features, and prespecified "benign" or "highly malignant" patterns based on the American Clinical Neurophysiology Society nomenclature) and other clinical, neurophysiologic (somatosensory-evoked potential), and biochemical prognosticators. Good outcome (Cerebral Performance Categories 1 and 2) and mortality predictions at 3 months were calculated. Among 357 patients, early electroencephalography reactivity and continuity and flexor or better motor reaction had greater than 70% positive predictive value for good outcome; reactivity (80.4%; 95% CI, 75.9-84.4%) and motor response (80.1%; 95% CI, 75.6-84.1%) had highest accuracy. Early benign electroencephalography heralded good outcome in 86.2% (95% CI, 79.8-91.1%). False positive rates for mortality were less than 5% for epileptiform or nonreactive early electroencephalography, nonreactive late electroencephalography, absent somatosensory-evoked potential, absent pupillary or corneal reflexes, presence of myoclonus, and neuron-specific enolase greater than 75 µg/L; accuracy was highest for

  14. Pulmonary Perfusion and Ventilation During Cardiopulmonary Bypass Are Not Associated with Improved Postoperative Outcomes After Cardiac Surgery

    Directory of Open Access Journals (Sweden)

    Yiliam F Rodriguez-Blanco

    2016-11-01

    Full Text Available ObjectivesClinical trials of either pulmonary perfusion or ventilation during cardiopulmonary bypass are equivocal. We hypothesized that to achieve significant improvement in outcomes both interventions had to be concurrent.DesignRetrospective case-control studySettingsMajor academic tertiary referral medical centerParticipants274 consecutive patients who underwent open heart surgery with cardiopulmonary bypass 2009 - 2013.InterventionsThe outcomes of 86 patients who received pulmonary perfusion and ventilation during cardiopulmonary bypass were retrospectively compared to the control group of 188 patients.Measurements and Main ResultsRespiratory complications rates were similar in both groups (33.7% vs. 33.5%, as were the rates of postoperative pneumonia (4.7% vs. 4.3%, pleural effusions (13.9% vs. 12.2% and re-intubations (9.3% vs. 9.1%. Rates of adverse postoperative cardiac events including ventricular tachycardia (9.3% vs. 8.5% and atrial fibrillation (33.7% vs. 28.2% were equivalent in both groups. Incidence of sepsis (8.1% vs. 5.3%, postoperative stroke (2.3% vs. 2.1%, acute kidney injury (2.3% vs. 3.7% and renal failure (5.8% vs. 3.7% were likewise comparable. Despite similar transfusion requirements, coagulopathy (12.8% vs. 5.3%, p=0.031 and the need for mediastinal re-exploration (17.4% vs. 9.6%, p=0.0633 were observed more frequently in the pulmonary perfusion and ventilation group, but the difference did not reach the statistical significance. ICU and hospital stays, and the ICU readmission rates (7.0% vs. 8.0% were similar in both groups.ConclusionsSimultaneous pulmonary perfusion and ventilation during cardiopulmonary bypass were not associated with improved clinical outcomes.

  15. Meta-analysis of randomized trials of effect of milrinone on mortality in cardiac surgery: an update.

    Science.gov (United States)

    Majure, David T; Greco, Teresa; Greco, Massimiliano; Ponschab, Martin; Biondi-Zoccai, Giuseppe; Zangrillo, Alberto; Landoni, Giovanni

    2013-04-01

    The long-term use of milrinone is associated with increased mortality in chronic heart failure. A recent meta-analysis suggested that it might increase mortality in patients undergoing cardiac surgery. The authors conducted an updated meta-analysis of randomized trials in patients undergoing cardiac surgery to determine if milrinone impacted survival. A meta-analysis. Hospitals. One thousand thirty-seven patients from 20 randomized trials. None. Biomed, Central, PubMed, EMBASE, the Cochrane central register of clinical trials, and conference proceedings were searched for randomized trials that compared milrinone versus placebo or any other control in adult and pediatric patients undergoing cardiac surgery. Authors of trials that did not include mortality data were contacted. Only trials for which mortality data were available were included. Overall analysis showed no difference in mortality between patients receiving milrinone versus control (12/554 [2.2%] in the milrinone group v 10/483 [2.1%] in the control arm; relative risk [RR] = 1.15; 95% confidence interval [CI], 0.55-2.43; p = 0.7) or in analysis restricted to adults (11/364 [3%] in the milrinone group v 9/371 [2.4%] in the control arm; RR = 1.17; 95% CI, 0.54-2.53; p = 0.7). Sensitivity analyses in trials with a low risk of bias showed a trend toward an increase in mortality with milrinone (8/153 [5.2%] in the milrinone arm v 2/152 [1.3%] in the control arm; RR = 2.71; 95% CI, 0.82-9; p for effect = 0.10). Despite theoretic concerns for increased mortality with intravenous milrinone in patients undergoing cardiac surgery, the authors were unable to confirm an adverse effect on survival. However, sensitivity analysis of high-quality trials showed a trend toward increased mortality with milrinone. Copyright © 2013 Elsevier Inc. All rights reserved.

  16. Effectiveness of massage therapy on post-operative outcomes among patients undergoing cardiac surgery: A systematic review

    Directory of Open Access Journals (Sweden)

    C. Ramesh

    2015-09-01

    Full Text Available The incidence and prevalence of cardiovascular disease (CVD are increasing rapidly in developing countries. Most patients with CVD do not respond to medical treatment and have to undergo cardiac surgery. This highly stressful experience results in increased levels of anxiety for patients. The objective of this review was to evaluate the efficacy of massage therapy on postoperative outcomes among patients undergoing cardiac surgery. A comprehensive literature search was made on PubMed-Medline, CINAHL, Science Direct, Scopus, Web of Science and the Cochrane library databases for original research articles published between 2000 and 2015. Original articles that reported the efficacy of massage therapy in patients undergoing cardiac surgery were included. The Cochrane data extraction form was used to extract data. A total of 297 studies were identified in the literature search. However, only seven studies were eligible for analysis. Of the seven studies, six studies demonstrated the effects of massage therapy on improving post-operative outcomes of patients, while one study found no evidence of improvement. Although the methods varied considerably, most of the studies included in this review reported positive results. Therefore, there is some evidence that massage therapy can lead to positive postoperative outcomes. Evidence of the effectiveness of massage therapy in patients undergoing cardiac surgery remains inconclusive. Additional research is needed to provide a strong evidence base for the use of massage therapy to improve post-operative outcomes and recovery among cardiac surgery patients

  17. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    Science.gov (United States)

    Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Methods and analysis 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. Trial registration number ChiCTR-IOR-15006971. PMID:27334883

  18. Right Atrial Dual-loop Reentry Tachycardia after Cardiac Surgery: Prevalence, Electrophysiologic Characteristics and Ablation Outcomes.

    Science.gov (United States)

    Yang, Jian-du; Sun, Qi; Guo, Xiao-Gang; Zhou, Gong-Bu; Liu, Xu; Luo, Bin; Wei, Hui-Qiang; Santangeli, Pasquale; Liang, Jackson J; Ma, Jian

    2018-04-03

    Right atrial dual-loop reentry tachycardia has been described in patients with open-heart surgery. However, the prevalence, electrophysiologic substrate and ablation outcomes have been poorly characterized. We aimed to investigate the prevalence, electrophysiologic substrate and ablation outcomes for RA dual-loop reentry tachycardia following cardiac surgery. We identified all patients with atrial tachycardia after cardiac surgery. We compared electrophysiologic findings and outcomes of those with RA dual-loop reentry tachycardia versus a control group of patients with RA macro-reentrant arrhythmias in the setting of linear RA free wall (FW) scar. Out of 127 patients with 152 post-surgical atrial tachycardias (ATs), 28 (18.4%) had diagnosis of RA dual-loop reentry and 24/28 (85.7%) had tricuspid annular (TA) reentry combined with FW incisional reentry. An incision length > 51.5mm along the FW predicted the substrate for a second loop. In 22/23 patients (95.7%) with initial ablation in the cavo-tricuspid isthmus, a change in the interval between Halo d to CS p could be recorded, while 15/23 patients (65.2%) had CS activation pattern change. Complete success was achieved in 25/28 (89.3%) and 64/69 (92.8%) in the dual-loop reentry and control groups, respectively. After mean follow-up of 33.9±24.2 months, 24/28 (85.7%) and 60/69 (86.95%) were free of arrhythmias after initial procedure in two groups. The prevalence of RA dual-loop reentry is 18.4% among ATs with prior atriotomy scar. A long incision should alert physician the possibility of the second loop at the FW. Halo and CS activation pattern are important clues for circuit transformation. Copyright © 2018. Published by Elsevier Inc.

  19. Implementing Sustainable Data Collection for a Cardiac Outcomes Registry in an Australian Public Hospital.

    Science.gov (United States)

    Cox, Nicholas; Brennan, Angela; Dinh, Diem; Brien, Rita; Cowie, Kath; Stub, Dion; Reid, Christopher M; Lefkovits, Jeffrey

    2018-04-01

    Clinical outcome registries are an increasingly vital component of ensuring quality and safety of patient care. However, Australian hospitals rarely have additional resources or the capacity to fund the additional staff time to complete the task of data collection and entry. At the same time, registry funding models do not support staff for the collection of data at the site but are directed towards the central registry tasks of data reporting, managing and quality monitoring. The sustainability of a registry is contingent on building efficiencies into data management and collection. We describe the methods used in a large Victorian public hospital to develop a sustainable data collection system for the Victorian Cardiac Outcomes Registry (VCOR), using existing staff and resources common to many public hospitals. We describe the features of the registry and the hospital specific strategies that allowed us to do this as part of our routine business of providing good quality cardiac care. All clinical staff involved in patient care were given some data collection task with the entry of these data embedded into the staff's daily workflow. A senior cardiology registrar was empowered to allocate data entry tasks to colleagues when data were found to be incomplete. The task of 30-day follow-up proved the most onerous part of data collection. Cath-lab nursing staff were allocated this role. With hospital accreditation and funding models moving towards performance based quality indicators, collection of accurate and reliable information is crucial. Our experience demonstrates the successful implementation of clinical outcome registry data collection in a financially constrained public hospital environment utilising existing resources. Copyright © 2017. Published by Elsevier B.V.

  20. Clinical Outcomes and Quality of Life in Recipients of Livers Donated after Cardiac Death

    Directory of Open Access Journals (Sweden)

    Neehar D. Parikh

    2015-01-01

    Full Text Available Donation after cardiac death (DCD has expanded in the last decade in the US; however, DCD liver utilization has flattened in recent years due to poor outcomes. We examined clinical and quality of life (QOL outcomes of DCD recipients by conducting a retrospective and cross-sectional review of patients from 2003 to 2010. We compared clinical outcomes of DCD recipients (n=60 to those of donation after brain death (DBD liver recipients (n=669 during the same time period. DCD recipients had significantly lower rates of 5-year graft survival (P<0.001 and a trend toward lower rates of 5-year patient survival (P=0.064 when compared to the DBD cohort. In order to examine QOL outcomes in our cohorts, we administered the Short Form Liver Disease Quality of Life questionnaire to 30 DCD and 60 DBD recipients. The DCD recipients reported lower generic and liver-specific QOL. We further stratified the DCD cohort by the presence of ischemic cholangiopathy (IC. Patients with IC reported lower QOL when compared to DBD recipients and those DCD recipients without IC (P<0.05. While the results are consistent with clinical experience, this is the first report of QOL in DCD recipients using standardized measures. These data can be used to guide future comparative effectiveness studies.

  1. The outcomes of simultaneous liver and kidney transplantation using donation after cardiac death organs.

    Science.gov (United States)

    Alhamad, Tarek; Spatz, Christin; Uemura, Tadahiro; Lehman, Eric; Farooq, Umar

    2014-12-15

    There has been a remarkable increase in simultaneous liver and kidney transplantations (SLK). As organ demand has increased, so has the use of donation after cardiac death (DCD). However, little is known about the outcomes of DCD in SLK. We performed a retrospective analysis using the United Network for Organ Sharing database to compare the outcomes of DCD SLK to donation after brain death (DBD) and determine the impact of donor and recipient factors on allograft and patient survival. Between 2002 and 2011, a total of 3,026 subjects received SLK from DBD and 98 from DCD. Kidney, liver, and patient survival from DCD donors were inferior to DBD at 1, 3, and 5 years (P=0.0056, P=0.0035, and P=0.0205, respectively). With the use of the Cox model, DCD was a significant risk factor for kidney and liver allograft failure and patient mortality. Recipient factors that were associated with worse allograft and patient outcomes included black race, diabetes, being on a ventilator, hospitalization, delayed graft function, hepatocellular carcinoma, and intensive care unit stay. Older age of the donor was also associated with worse outcomes. Despite the decreased allograft and patient survival compared with DBD, DCD SLK provides an acceptable option for SLK, with a survival probability of more than 50% at 5 years.

  2. Work-related outcome after acute coronary syndrome: Implications of complex cardiac rehabilitation in occupational medicine.

    Science.gov (United States)

    Lamberti, Monica; Ratti, Gennaro; Gerardi, Donato; Capogrosso, Cristina; Ricciardi, Gianfranco; Fulgione, Cosimo; Latte, Salvatore; Tammaro, Paolo; Covino, Gregorio; Nienhaus, Albert; Grazillo, Elpidio Maria; Mallardo, Mario; Capogrosso, Paolo

    2016-01-01

    Coronary heart disease is frequent in the working-age population. Traditional outcomes, such as mortality and hospital readmission, are useful for evaluating prognosis. Fit-for-work is an emerging outcome with clinical as well as socioeconomic significance. We describe the possible benefit of a cardiac rehabilitation (CR) program for return to work (RTW) after acute coronary syndrome (ACS). We evaluated 204 patients with recent ACS. They were divided into 4 groups on the basis of their occupational work load: very light (VL), light (L), moderate (M), and heavy (H). Work-related outcomes were assessed with the Work Performance Scale (WPS) of the Functional Status Questionnaire and as "days missed from work" (DMW) in the previous 4 weeks. The variables considered for outcomes were percent ejection fraction, functional capacity expressed in metabolic equivalents (METs), and participation or non-participation in the CR program (CR+ and CR-). One hundred thirty (66%) patients took part in the CR program. Total WPS scores for CR+ and CR- subgroups were VL group: 18±4 vs. 14±4 (p workplace, in particular among clerical workers. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

  3. Imaging outcomes for trials of remyelination in multiple sclerosis.

    Science.gov (United States)

    Mallik, Shahrukh; Samson, Rebecca S; Wheeler-Kingshott, Claudia A M; Miller, David H

    2014-12-01

    Trials of potential neuroreparative agents are becoming more important in the spectrum of multiple sclerosis research. Appropriate imaging outcomes are required that are feasible from a time and practicality point of view, as well as being sensitive and specific to myelin, while also being reproducible and clinically meaningful. Conventional MRI sequences have limited specificity for myelination. We evaluate the imaging modalities which are potentially more specific to myelin content in vivo, such as magnetisation transfer ratio (MTR), restricted proton fraction f (from quantitative magnetisation transfer measurements), myelin water fraction and diffusion tensor imaging (DTI) metrics, in addition to positron emission tomography (PET) imaging. Although most imaging applications to date have focused on the brain, we also consider measures with the potential to detect remyelination in the spinal cord and in the optic nerve. At present, MTR and DTI measures probably offer the most realistic and feasible outcome measures for such trials, especially in the brain. However, no one measure currently demonstrates sufficiently high sensitivity or specificity to myelin, or correlation with clinical features, and it should be useful to employ more than one outcome to maximise understanding and interpretation of findings with these sequences. PET may be less feasible for current and near-future trials, but is a promising technique because of its specificity. In the optic nerve, visual evoked potentials can indicate demyelination and should be correlated with an imaging outcome (such as optic nerve MTR), as well as clinical measures. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  4. A randomized clinical trial of continuous aspiration of subglottic secretions in cardiac surgery patients.

    Science.gov (United States)

    Kollef, M H; Skubas, N J; Sundt, T M

    1999-11-01

    To determine whether the application of continuous aspiration of subglottic secretions (CASS) is associated with a decreased incidence of ventilator-associated pneumonia (VAP). Prospective clinical trial. Cardiothoracic ICU (CTICU) of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. Three hundred forty-three patients undergoing cardiac surgery and requiring mechanical ventilation in the CTICU. Patients were assigned to receive either CASS, using a specially designed endotracheal tube (Hi-Lo Evac; Mallinckrodt Inc; Athlone, Ireland), or routine postoperative medical care without CASS. One hundred sixty patients were assigned to receive CASS, and 183 were assigned to receive routine postoperative medical care without CASS. The two groups were similar at the time of randomization with regard to demographic characteristics, surgical procedures performed, and severity of illness. Risk factors for the development of VAP were also similar during the study period for both treatment groups. VAP was seen in 8 patients (5.0%) receiving CASS and in 15 patients (8. 2%) receiving routine postoperative medical care without CASS (relative risk, 0.61%; 95% confidence interval, 0.27 to 1.40; p = 0. 238). Episodes of VAP occurred statistically later among patients receiving CASS ([mean +/- SD] 5.6 +/- 2.3 days) than among patients who did not receive CASS (2.9 +/- 1.2 days); (p = 0.006). No statistically significant differences for hospital mortality, overall duration of mechanical ventilation, lengths of stay in the hospital or CTICU, or acquired organ system derangements were found between the two treatment groups. No complications related to CASS were observed in the intervention group. Our findings suggest that CASS can be safely administered to patients undergoing cardiac surgery. The occurrence of VAP can be significantly delayed among patients undergoing cardiac surgery using this simple-to-apply technique.

  5. Targeted Temperature Management for 48 vs 24 Hours and Neurologic Outcome After Out-of-Hospital Cardiac Arrest

    DEFF Research Database (Denmark)

    Kirkegaard, Hans; Søreide, Eldar; de Haas, Inge

    2017-01-01

    Importance: International resuscitation guidelines recommend targeted temperature management (TTM) at 33°C to 36°C in unconscious patients with out-of-hospital cardiac arrest for at least 24 hours, but the optimal duration of TTM is uncertain. Objective: To determine whether TTM at 33°C for 48....... Secondary outcomes included 6-month mortality, including time to death, the occurrence of adverse events, and intensive care unit resource use. Results: In 355 patients who were randomized (mean age, 60 years; 295 [83%] men), 351 (99%) completed the trial. Of these patients, 69% (120/175) in the 48-hour.......5%; 95% CI, -16.1% to 3.1%; RR, 0.81; 95% CI, 0.59-1.11; P = .19). There was no significant difference in the time to mortality between the 48-hour group and the 24-hour group (hazard ratio, 0.79; 95% CI, 0.54-1.15; P = .22). Adverse events were more common in the 48-hour group (97%) than in the 24-hour...

  6. Safety and effects of two red blood cell transfusion strategies in pediatric cardiac surgery patients: a randomized controlled trial

    NARCIS (Netherlands)

    de Gast-Bakker, D. H.; de Wilde, R. B. P.; Hazekamp, M. G.; Sojak, V.; Zwaginga, J. J.; Wolterbeek, R.; de Jonge, E.; Gesink-van der Veer, B. J.

    2013-01-01

    To investigate the safety and effects of a restrictive red blood cell (RBC) transfusion strategy in pediatric cardiac surgery patients. Randomized controlled trial. Pediatric ICU in an academic tertiary care center, Leiden University Medical Center, Leiden, The Netherlands. One hundred seven

  7. Outcome following postanoxic status epilepticus in patients with targeted temperature management after cardiac arrest.

    Science.gov (United States)

    Dragancea, Irina; Backman, Sofia; Westhall, Erik; Rundgren, Malin; Friberg, Hans; Cronberg, Tobias

    2015-08-01

    Postanoxic electrographic status epilepticus (ESE) is considered a predictor of poor outcome in resuscitated patients after cardiac arrest (CA). Observational data suggest that a subgroup of patients may have a good outcome. This study aimed to describe the prevalence of ESE and potential clinical and electrographic prognostic markers. In this retrospective single study, we analyzed consecutive patients who suffered from CA, and who received temperature management and were monitored with simplified continuous EEG (cEEG) during a five-year period. The patients' charts and cEEG data were initially screened to identify patients with clinical seizures or ESE. The cEEG diagnosis of ESE was retrospectively reanalyzed according to strict criteria by a neurophysiologist blinded to patient outcome. The EEG background patterns prior to the onset of ESE, duration of ESE, presence of clinical seizures, and use of antiepileptic drugs were analyzed. The results of somatosensory-evoked potentials (SSEPs) and neuron-specific enolase (NSE) at 48 h after CA were described in all patients with ESE. Antiepileptic treatment strategies were not protocolized. Outcome was evaluated using the Cerebral Performance Category (CPC) scale at 6 months, and good outcome was defined as CPC 1-2. Of 127 patients, 41 (32%) developed ESE. Twenty-five patients had a discontinuous EEG background prior to ESE, and all died without regaining consciousness. Sixteen patients developed a continuous EEG background prior to the start of ESE, four of whom survived, three with CPC 1-2 and one with CPC 3 at 6 months. Among survivors, ESE developed at a median of 46 h after CA. All had preserved N20 peaks on SSEP and NSE values of 18-37 μg/l. Electrographic status epilepticus is common among comatose patients after cardiac arrest, with few survivors. A combination of a continuous EEG background prior to ESE, preserved N20 peaks on SSEPs, and low or moderately elevated NSE levels may indicate a good outcome. This

  8. The patient education - Learning and Coping Strategies - improves adherence in cardiac rehabilitation (LC-REHAB): A randomised controlled trial.

    Science.gov (United States)

    Lynggaard, Vibeke; Nielsen, Claus Vinther; Zwisler, Ann-Dorthe; Taylor, Rod S; May, Ole

    2017-06-01

    Despite proven benefits of cardiac rehabilitation (CR), adherence to CR remains suboptimal. This trial aimed to assess the impact of the patient education 'Learning and Coping Strategies' (LC) on patient adherence to an eight-week CR program. 825 patients with ischaemic heart disease or heart failure were open label randomised to either the LC arm (LC plus CR) or the control arm (CR alone) across three hospital units in Denmark. Both arms received same amount of training and education hours. LC consisted of individual clarifying interviews, participation of experienced patients as co-educators, situational, reflective and inductive teaching. The control arm received structured deductive teaching. The primary outcomes were patient adherence to at least 75% of the exercise training or education sessions. We tested for subgroup effects on the primary outcomes using interaction terms. The primary outcomes were compared across arms using logistic regression. More patients in the LC arm adhered to at least 75% of the exercise training sessions than control (80% versus 73%, adjusted odds ratio (OR):1.48; 95% CI:1.07 to 2.05, P=0.018) and 75% of education sessions (79% versus 70%, adjusted OR:1.61, 1.17 to 2.22, P=0.003). Some evidence of larger effects of LC on adherence was seen for patients with heart failure, low education and household income. Addition of LC strategies improved adherence in rehabilitation both in terms of exercise training and education. Patients with heart failure, low levels of education and household income appear to benefit most from this adherence promoting intervention. www.clinicaltrials.gov identifier NCT01668394. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Risk-taking attitudes and their association with process and outcomes of cardiac care: a cohort study

    Directory of Open Access Journals (Sweden)

    Knudtson Merril L

    2009-08-01

    Full Text Available Abstract Background Prior research reveals that processes and outcomes of cardiac care differ across sociodemographic strata. One potential contributing factor to such differences is the personality traits of individuals within these strata. We examined the association between risk-taking attitudes and cardiac patients' clinical and demographic characteristics, the likelihood of undergoing invasive cardiac procedures and survival. Methods We studied a large inception cohort of patients who underwent cardiac catheterization between July 1998 and December 2001. Detailed clinical and demographic data were collected at time of cardiac catheterization and through a mailed survey one year post-catheterization. The survey included three general risk attitude items from the Jackson Personality Inventory. Patients' (n = 6294 attitudes toward risk were categorized as risk-prone versus non-risk-prone and were assessed for associations with baseline clinical and demographic characteristics, treatment received (i.e., medical therapy, coronary artery bypass graft (CABG surgery, percutaneous coronary intervention (PCI, and survival (to December 2005. Results 2827 patients (45% were categorized as risk-prone. Having risk-prone attitudes was associated with younger age (p Conclusion These exploratory findings suggest that patient attitudes toward risk taking may contribute to some of the documented differences in use of invasive cardiac procedures. An awareness of these associations could help healthcare providers as they counsel patients regarding cardiac care decisions.

  10. Reporting outcomes of back pain trials: a modified Delphi study

    DEFF Research Database (Denmark)

    Froud, R.; Eldridge, S.; Kovacs, F.

    2011-01-01

    trials. METHODS: We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi......BACKGROUND: Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret. AIM: To facilitate consensus on a statement recommending reporting methods for future low back pain...... process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement. RESULTS: A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes...

  11. The Aliskiren Trial to Minimize OutcomeS in Patients with HEart failure trial (ATMOSPHERE)

    DEFF Research Database (Denmark)

    Krum, Henry; McMurray, John J V; Abraham, William T

    2015-01-01

    in ATMOSPHERE with those in the Prospective comparison of Angiotensin Receptor neprilysin inhibitors with Angiotensin converting enzyme inhibitors to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF); and (iii) compare the characteristics of patients with and without...... dysfunction, and were treated with a mineralocorticoid receptor antagonist. In ATMOSPHERE, patients with diabetes differed in numerous ways from those without. Patients with diabetes were older and had worse heart failure status but a similar left ventricular ejection fraction (mean 28%); they had a higher...... body mass index and more co-morbidity, especially hypertension and coronary heart disease. Mean estimated glomerular filtration rate was slightly lower in those with diabetes compared with those without. CONCLUSION: ATMOSPHERE will determine whether patients with HF and reduced ejection fraction...

  12. [Acute kidney injury after pediatric cardiac surgery: risk factors and outcomes. Proposal for a predictive model].

    Science.gov (United States)

    Cardoso, Bárbara; Laranjo, Sérgio; Gomes, Inês; Freitas, Isabel; Trigo, Conceição; Fragata, Isabel; Fragata, José; Pinto, Fátima

    2016-02-01

    To characterize the epidemiology and risk factors for acute kidney injury (AKI) after pediatric cardiac surgery in our center, to determine its association with poor short-term outcomes, and to develop a logistic regression model that will predict the risk of AKI for the study population. This single-center, retrospective study included consecutive pediatric patients with congenital heart disease who underwent cardiac surgery between January 2010 and December 2012. Exclusion criteria were a history of renal disease, dialysis or renal transplantation. Of the 325 patients included, median age three years (1 day-18 years), AKI occurred in 40 (12.3%) on the first postoperative day. Overall mortality was 13 (4%), nine of whom were in the AKI group. AKI was significantly associated with length of intensive care unit stay, length of mechanical ventilation and in-hospital death (p<0.01). Patients' age and postoperative serum creatinine, blood urea nitrogen and lactate levels were included in the logistic regression model as predictor variables. The model accurately predicted AKI in this population, with a maximum combined sensitivity of 82.1% and specificity of 75.4%. AKI is common and is associated with poor short-term outcomes in this setting. Younger age and higher postoperative serum creatinine, blood urea nitrogen and lactate levels were powerful predictors of renal injury in this population. The proposed model could be a useful tool for risk stratification of these patients. Copyright © 2015 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  13. Maternal obesity, gestational weight gain and childhood cardiac outcomes: role of childhood body mass index.

    Science.gov (United States)

    Toemen, L; Gishti, O; van Osch-Gevers, L; Steegers, E A P; Helbing, W A; Felix, J F; Reiss, I K M; Duijts, L; Gaillard, R; Jaddoe, V W V

    2016-07-01

    Maternal obesity may affect cardiovascular outcomes in the offspring. We examined the associations of maternal prepregnancy body mass index and gestational weight gain with childhood cardiac outcomes and explored whether these associations were explained by parental characteristics, infant characteristics or childhood body mass index. In a population-based prospective cohort study among 4852 parents and their children, we obtained maternal weight before pregnancy and in early, mid- and late pregnancy. At age 6 years, we measured aortic root diameter (cm) and left ventricular dimensions. We calculated left ventricular mass (g), left ventricular mass index (g m(-2.7)), relative wall thickness ((2 × left ventricular posterior wall thickness)/left ventricular diameter), fractional shorting (%), eccentric left ventricular hypertrophy and concentric remodeling. A one standard deviation score (SDS) higher maternal prepregnancy body mass index was associated with higher left ventricular mass (0.10 SDS (95% confidence interval (CI) 0.08, 0.13)), left ventricular mass index (0.06 SDS (95% CI 0.03, 0.09)) and aortic root diameter (0.09 SDS (95% CI 0.06, 0.12)), but not with relative wall thickness or fractional shortening. A one SDS higher maternal prepregnancy body mass index was associated with an increased risk of eccentric left ventricular hypertrophy (odds ratio 1.21 (95% CI 1.03, 1.41)), but not of concentric remodeling. When analyzing the effects of maternal weight in different periods simultaneously, only maternal prepregnancy weight and early pregnancy weight were associated with left ventricular mass, left ventricular mass index and aortic root diameter (P-valuesMaternal prepregnancy body mass index and weight gain in early pregnancy are both associated with offspring cardiac structure in childhood, but these associations seem to be fully explained by childhood body mass index.

  14. Impact of etiology on the outcomes in heart failure patients treated with cardiac resynchronization therapy: a meta-analysis.

    Directory of Open Access Journals (Sweden)

    Yanmei Chen

    Full Text Available BACKGROUND: Cardiac resynchronization therapy (CRT has been extensively demonstrated to benefit heart failure patients, but the role of underlying heart failure etiology in the outcomes was not consistently proven. This meta-analysis aimed to determine whether efficacy and effectiveness of CRT is affected by underlying heart failure etiology. METHODS AND RESULTS: Searches of MEDLINE, EMBASE and Cochrane databases were conducted to identify RCTs and observational studies that reported clinical and functional outcomes of CRT in ischemic cardiomyopathy (ICM and non-ischemic cardiomyopathy (NICM patients. Efficacy of CRT was assessed in 7 randomized controlled trials (RCTs with 7072 patients and effectiveness of CRT was evaluated in 14 observational studies with 3463 patients In the pooled analysis of RCTs, we found that CRT decreased mortality or heart failure hospitalization by 29% in ICM patients (95% confidence interval [CI], 21% to 35%, and by 28% (95% CI, 18% to 37% in NICM patients. No significant difference was observed between the 2 etiology groups (P = 0.55. In the pooled analysis of observational studies, however, we found that ICM patients had a 54% greater risk for mortality or HF hospitalization than NICM patients (relative risk: 1.54; 95% CI: 1.30-1.83; P<0.001. Both RCTs and observational studies demonstrated that NICM patients had greater echocardiographic improvements in the left ventricular ejection fraction and end-systolic volume, as compared with ICM patients (both P<0.001. CONCLUSION: CRT might reduce mortality or heart failure hospitalization in both ICM and NICM patients similarly. The improvement of the left ventricular function and remodeling is greater in NICM patients.

  15. Improved Outcome of Cardiac Extracorporeal Membrane Oxygenation in Infants and Children Using Magnetic Levitation Centrifugal Pumps.

    Science.gov (United States)

    Luciani, Giovanni Battista; Hoxha, Stiljan; Torre, Salvatore; Rungatscher, Alessio; Menon, Tiziano; Barozzi, Luca; Faggian, Giuseppe

    2016-01-01

    Extracorporeal membrane oxygenation (ECMO) has traditionally been and, for the most part, still is being performed using roller pumps. Use of first-generation centrifugal pumps has yielded controversial outcomes, perhaps due to mechanical properties of the same and the ensuing risk of hemolysis and renal morbidity. Latest-generation centrifugal pumps, using magnetic levitation (ML), exhibit mechanical properties which may have overcome limitations of first-generation devices. This retrospective study aimed to assess the safety and efficacy of veno-arterial (V-A) ECMO for cardiac indications in neonates, infants, and children, using standard (SP) and latest-generation ML centrifugal pumps. Between 2002 and 2014, 33 consecutive neonates, infants, and young children were supported using V-A ECMO for cardiac indications. There were 21 males and 12 females, with median age of 29 days (4 days-5 years) and a median body weight of 3.2 kg (1.9-18 kg). Indication for V-A ECMO were acute circulatory collapse in ICU or ward after cardiac repair in 16 (49%) patients, failure to wean after repair of complex congenital heart disease in 9 (27%), fulminant myocarditis in 4 (12%), preoperative sepsis in 2 (6%), and refractory tachy-arrhythmias in 2 (6%). Central cannulation was used in 27 (81%) patients and peripheral in 6. Seven (21%) patients were supported with SP and 26 (79%) with ML centrifugal pumps. Median duration of support was 82 h (range 24-672 h), with 26 (79%) patients weaned from support. Three patients required a second ECMO run but died on support. Seventeen (51%) patients required peritoneal dialysis for acute renal failure. Overall survival to discharge was 39% (13/33 patients). All patients with fulminant myocarditis and with refractory arrhythmias were weaned, and five (83%) survived, whereas no patient supported for sepsis survived. Risk factors for hospital mortality included lower (pumps in infants and children yields outcomes absolutely comparable to

  16. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Andrew M. Busch

    2017-04-01

    Full Text Available Abstract Background Smoking cessation following hospitalization for Acute Coronary Syndrome (ACS significantly reduces subsequent mortality. Depressed mood is a major barrier to cessation post-ACS. Although existing counseling treatments address smoking and depression independently in ACS patients, no integrated treatment addresses both. We developed an integrated treatment combining gold standard cessation counseling with behavioral activation-based mood management; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS. The purpose of this pilot randomized controlled trial was to test feasibility, acceptability, and preliminary efficacy of BAT-CS vs. Standard of Care (SC. Methods Participants were recruited during hospitalization for ACS and were randomly assigned to BAT-CS or SC. The nicotine patch was offered in both conditions. Smoking, mood, and stress outcomes were collected at end-of-treatment and 24-week follow-up. Results Fifty-nine participants (28 BAT-CS, 31 SC were recruited over 42 weeks, and assessment completion was above 80% in both conditions. Treatment acceptability and fidelity were high. At 24 week follow-up adjusted odds ratios favoring BAT-CS were 1.27 (95% CI: 0.41–3.93 for 7-day point prevalence abstinence and 1.27 (95% CI: 0.42–3.82 for continuous abstinence. Time to first smoking lapse was significantly longer in BAT-CS (62.4 vs. 31.8 days, p = 0.03. At 24-weeks, effect sizes for mood and stress outcomes ranged from η2 partial of.07–.11, with significant between treatment effects for positive affect, negative affect, and stress. Conclusions The design of this study proved feasible and acceptable. Results provide preliminary evidence that combining behavioral activation with standard smoking cessation counseling could be efficacious for this high risk population. A larger trial with longer follow-up is warranted. Trial registration NCT01964898 . First received by clinicaltrials.gov October 15, 2013.

  17. Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM: a randomised controlled trial [ISRCTN72884263

    Directory of Open Access Journals (Sweden)

    Lane Deirdre

    2003-09-01

    Full Text Available Abstract Background Cardiac rehabilitation following myocardial infarction reduces subsequent mortality, but uptake and adherence to rehabilitation programmes remains poor, particularly among women, the elderly and ethnic minority groups. Evidence of the effectiveness of home-based cardiac rehabilitation remains limited. This trial evaluates the effectiveness and cost-effectiveness of home-based compared to hospital-based cardiac rehabilitation. Methods/design A pragmatic randomised controlled trial of home-based compared with hospital-based cardiac rehabilitation in four hospitals serving a multi-ethnic inner city population in the United Kingdom was designed. The home programme is nurse-facilitated, manual-based using the Heart Manual. The hospital programmes offer comprehensive cardiac rehabilitation in an out-patient setting. Patients We will randomise 650 adult, English or Punjabi-speaking patients of low-medium risk following myocardial infarction, coronary angioplasty or coronary artery bypass graft who have been referred for cardiac rehabilitation. Main outcome measures Serum cholesterol, smoking cessation, blood pressure, Hospital Anxiety and Depression Score, distance walked on Shuttle walk-test measured at 6, 12 and 24 months. Adherence to the programmes will be estimated using patient self-reports of activity. In-depth interviews with non-attendees and non-adherers will ascertain patient views and the acceptability of the programmes and provide insights about non-attendance and aims to generate a theory of attendance at cardiac rehabilitation. The economic analysis will measure National Health Service costs using resource inputs. Patient costs will be established from the qualitative research, in particular how they affect adherence. Discussion More data are needed on the role of home-based versus hospital-based cardiac rehabilitation for patients following myocardial infarction and revascularisation, which would be provided by the

  18. PONTIAC (NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease): a prospective randomized controlled trial.

    Science.gov (United States)

    Huelsmann, Martin; Neuhold, Stephanie; Resl, Michael; Strunk, Guido; Brath, Helmut; Francesconi, Claudia; Adlbrecht, Christopher; Prager, Rudolf; Luger, Anton; Pacher, Richard; Clodi, Martin

    2013-10-08

    The study sought to assess the primary preventive effect of neurohumoral therapy in high-risk diabetic patients selected by N-terminal pro-B-type natriuretic peptide (NT-proBNP). Few clinical trials have successfully demonstrated the prevention of cardiac events in patients with diabetes. One reason for this might be an inaccurate selection of patients. NT-proBNP has not been assessed in this context. A total of 300 patients with type 2 diabetes, elevated NT-proBNP (>125 pg/ml) but free of cardiac disease were randomized. The "control" group was cared for at 4 diabetes care units; the "intensified" group was additionally treated at a cardiac outpatient clinic for the up-titration of renin-angiotensin system (RAS) antagonists and beta-blockers. The primary endpoint was hospitalization/death due to cardiac disease after 2 years. At baseline, the mean age of the patients was 67.5 ± 9 years, duration of diabetes was 15 ± 12 years, 37% were male, HbA1c was 7 ± 1.1%, blood pressure was 151 ± 22 mm Hg, heart rate was 72 ± 11 beats/min, median NT-proBNP was 265.5 pg/ml (interquartile range: 180.8 to 401.8 pg/ml). After 12 months there was a significant difference between the number of patients treated with a RAS antagonist/beta-blocker and the dosage reached between groups (p titration of RAS antagonists and beta-blockers to maximum tolerated dosages is an effective and safe intervention for the primary prevention of cardiac events for diabetic patients pre-selected using NT-proBNP. (Nt-proBNP Guided Primary Prevention of CV Events in Diabetic Patients [PONTIAC]; NCT00562952). Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. Comorbidity and favorable neurologic outcome after out-of-hospital cardiac arrest in patients of 70 years and older

    NARCIS (Netherlands)

    Beesems, Stefanie G.; Blom, Marieke T.; van der Pas, Martine H. A.; Hulleman, Michiel; van de Glind, Esther M. M.; van Munster, Barbara C.; Tijssen, Jan G. P.; Tan, Hanno L.; van Delden, Johannes J. M.; Koster, Rudolph W.

    2015-01-01

    Advanced age is reported to be associated with lower survival after out-of-hospital cardiac arrest (OHCA). We aimed to establish survival rate and neurological outcome at hospital discharge after OHCA in older patients and evaluated whether pre-OHCA comorbidity was associated with favorable

  20. Comorbidity and favorable neurologic outcome after out-of-hospital cardiac arrest in patients of 70 years and older

    NARCIS (Netherlands)

    Beesems, Stefanie G.; Blom, Marieke T.; van der Pas, Martine H. A.; Hulleman, Michiel; van de Glind, Esther M. M.; van Munster, Barbara C.; Tijssen, Jan G. P.; Tan, Hanno L.; van Delden, Johannes J. M.; Koster, Rudolph W.

    Introduction: Advanced age is reported to be associated with lower survival after out-of-hospital cardiac arrest (OHCA). We aimed to establish survival rate and neurological outcome at hospital discharge after OHCA in older patients and evaluated whether pre-OHCA comorbidity was associated with

  1. Effect of maternal age and cardiac disease severity on outcome of pregnancy in women with congenital heart disease.

    Science.gov (United States)

    Furenäs, Eva; Eriksson, Peter; Wennerholm, Ulla-Britt; Dellborg, Mikael

    2017-09-15

    There is an increasing prevalence of women with congenital heart defects reaching childbearing age. In western countries women tend to give birth at a higher age compared to some decades ago. We evaluated the CARdiac disease in PREGnancy (CARPREG) and modified World Health Organization (mWHO) risk classifications for cardiac complications during pregnancies in women with congenital heart defects and analyzed the impact of age on risk of obstetric and fetal outcome. A single-center observational study of cardiac, obstetric, and neonatal complications with data from cardiac and obstetric records of pregnancies in women with congenital heart disease. Outcomes of 496 pregnancies in 232 women, including induced abortion, miscarriage, stillbirth, and live birth were analyzed regarding complications, maternal age, mode of delivery, and two risk classifications: CARPREG and mWHO. There were 28 induced abortions, 59 fetal loss, 409 deliveries with 412 neonates. Cardiac (14%), obstetric (14%), and neonatal (15%) complications were noted, including one maternal death and five stillbirths. The rate of cesarean section was 19%. Age above 35years was of borderline importance for cardiac complications (p=0.054) and was not a significant additional risk factor for obstetric or neonatal complications. Both risk classifications had moderate clinical utility, with area under the curve (AUC) 0.71 for CARPREG and 0.65 for mWHO on cardiac complications. Pregnancy complications in women with congenital heart disease are common but severe complications are rare. Advanced maternal age does not seem to affect complication rate. Existing risk classification systems are insufficient in predicting complications. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Patient-reported mental and physical health outcomes are independent predictors of one-year mortality and cardiac events across cardiac diagnoses. Findings from the national DenHeart survey."

    DEFF Research Database (Denmark)

    Berg, Selina Kikkenborg; Thorup, Charlotte Brun; Borregaard, Britt

    2018-01-01

    -reported outcomes at hospital discharge as a predictor of mortality and cardiac events. Design: A cross-sectional survey with register follow-up. Methods: Participants: All patients discharged from April 2013 to April 2014 from five national heart centres in Denmark. Main outcomes: Patient-reported outcomes......Aims: Patient-reported quality of life and anxiety/depression scores provide important prognostic information independently of traditional clinical data. The aims of this study were to describe: (a) mortality and cardiac events one year after hospital discharge across cardiac diagnoses; (b) patient...

  3. Machine Perfusion Versus Cold Storage for the Preservation of Kidneys Donated After Cardiac Death A Multicenter, Randomized, Controlled Trial

    NARCIS (Netherlands)

    Jochmans, Ina; Moers, Cyril; Smits, Jacqueline M.; Leuvenink, Henri G. D.; Treckmann, Juergen; Paul, Andreas; Rahmel, Axel; Squifflet, Jean-Paul; van Heurn, Ernest; Monbaliu, Diethard; Ploeg, Rutger J.; Pirenne, Jacques

    2010-01-01

    Objective: Hypothermic machine perfusion may improve outcome after transplantation of kidneys donated after cardiac death (DCD), but no sufficiently powered prospective studies have been reported. Because organ shortage has led to an increased use of DCD kidneys, we aimed to compare hypothermic

  4. Successful cardiac transplantation outcomes in patients with adult congenital heart disease.

    Science.gov (United States)

    Menachem, Jonathan N; Golbus, Jessica R; Molina, Maria; Mazurek, Jeremy A; Hornsby, Nicole; Atluri, Pavan; Fuller, Stephanie; Birati, Edo Y; Kim, Yuli Y; Goldberg, Lee R; Wald, Joyce W

    2017-09-01

    The purpose of our study is (1) to characterise patients with congenital heart disease undergoing heart transplantation by adult cardiac surgeons in a large academic medical centre and (2) to describe successful outcomes associated with our multidisciplinary approach to the evaluation and treatment of adults with congenital heart disease (ACHD) undergoing orthotopic heart transplantation (OHT). Heart failure is the leading cause of death in patients with ACHD leading to increasing referrals for OHT. The Penn Congenital Transplant Database comprises a cohort of patients with ACHD who underwent OHT between March 2010 and April 2016. We performed a retrospective cohort study of the 20 consecutive patients. Original cardiac diagnoses include single ventricle palliated with Fontan (n=8), dextro-transposition of the great arteries after atrial switch (n=4), tetralogy of Fallot (n=4), pulmonary atresia (n=1), Ebstein anomaly (n=1), unrepaired ventricular septal defect (n=1) and Noonan syndrome with coarctation of the aorta (n=1). Eight patients required pretransplant inotropes and two required pretransplant mechanical support. Nine patients underwent heart-liver transplant and three underwent heart-lung transplant. Three patients required postoperative mechanical circulatory support. Patients were followed for an average of 38 months as of April 2016, with 100% survival at 30 days and 1 year and 94% overall survival (19/20 patients). ACHD-OHT patients require highly specialised, complex and multidisciplinary healthcare. The success of our programme is attributed to using team-based, patient-centred care including our multidisciplinary staff and specialists across programmes and departments. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  5. Fetal cardiac axis in tetralogy of Fallot: associations with prenatal findings, genetic anomalies and postnatal outcome.

    Science.gov (United States)

    Zhao, Y; Edington, S; Fleenor, J; Sinkovskaya, E; Porche, L; Abuhamad, A

    2017-07-01

    To compare prenatal findings, associated genetic anomalies and postnatal outcome in fetuses with tetralogy of Fallot (TOF) with normal cardiac axis (CAx) and those with abnormal CAx. In this retrospective cohort study, 85 cases diagnosed with TOF by prenatal ultrasound at our clinic between 2005 and 2015 were reviewed. Follow-up ultrasound and postnatal outcome were available for 68 cases. One case complicated with absent pulmonary valve syndrome and a further seven cases diagnosed postnatally with anomalies other than TOF were excluded from the study. The remaining 60 cases of postnatally confirmed TOF were divided according to CAx into two groups: those with normal CAx (n = 33) and those with abnormal CAx (n = 27). CAx was defined as the angle between the interventricular septum and midline of the fetal thorax at the level of the four-chamber view. CAx > 65° or < 25° was considered abnormal. Prenatal sonographic findings, associated genetic anomalies and postnatal outcome were compared between the two groups. Fetuses with TOF and abnormal CAx were more likely to have pulmonary atresia (40.7% vs 15.2%; P = 0.026) and right-sided aortic arch (48.1% vs 21.2%; P = 0.028) than those with normal CAx. Postnatal death occurred in 30.4% of infants with abnormal CAx vs 6.5% with normal CAx (P = 0.028). Incidence of tested genetic anomalies was similar between the two groups. In fetuses with TOF, abnormal CAx is associated with the presence of pulmonary atresia, right-sided aortic arch and a higher risk of postnatal death. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

  6. Outcome quality of in-patient cardiac rehabilitation in elderly patients--identification of relevant parameters.

    Science.gov (United States)

    Salzwedel, Annett; Nosper, Manfred; Röhrig, Bernd; Linck-Eleftheriadis, Sigrid; Strandt, Gert; Völler, Heinz

    2014-02-01

    Outcome quality management requires the consecutive registration of defined variables. The aim was to identify relevant parameters in order to objectively assess the in-patient rehabilitation outcome. From February 2009 to June 2010 1253 patients (70.9 ± 7.0 years, 78.1% men) at 12 rehabilitation clinics were enrolled. Items concerning sociodemographic data, the impairment group (surgery, conservative/interventional treatment), cardiovascular risk factors, structural and functional parameters and subjective health were tested in respect of their measurability, sensitivity to change and their propensity to be influenced by rehabilitation. The majority of patients (61.1%) were referred for rehabilitation after cardiac surgery, 38.9% after conservative or interventional treatment for an acute coronary syndrome. Functionally relevant comorbidities were seen in 49.2% (diabetes mellitus, stroke, peripheral artery disease, chronic obstructive lung disease). In three key areas 13 parameters were identified as being sensitive to change and subject to modification by rehabilitation: cardiovascular risk factors (blood pressure, low-density lipoprotein cholesterol, triglycerides), exercise capacity (resting heart rate, maximal exercise capacity, maximal walking distance, heart failure, angina pectoris) and subjective health (IRES-24 (indicators of rehabilitation status): pain, somatic health, psychological well-being and depression as well as anxiety on the Hospital Anxiety and Depression Scale). The outcome of in-patient rehabilitation in elderly patients can be comprehensively assessed by the identification of appropriate key areas, that is, cardiovascular risk factors, exercise capacity and subjective health. This may well serve as a benchmark for internal and external quality management.

  7. Factors Promoting Survival After Prolonged Resuscitation Attempts: A Case of Survival With Good Neurological Outcome Following 60 Minutes of Downtime After Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Bell, Douglas; Gluer, Robert; Murdoch, Dale

    2018-03-01

    Sudden cardiac arrest is a significant cause of death affecting approximately 25,000 people in Australia annually. We present an out-of-hospital cardiac arrest (OHCA) with prolonged down time and recurrent ventricular arrhythmias treated with extra-corporeal membrane oxygenation. The patient survived to hospital discharge with good neurological outcome. The patient's excellent outcome was a result of immediate good quality CPR, high level premorbid function, reversible cause of arrest and rapid access to an ECMO centre. Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

  8. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention.

    Science.gov (United States)

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-06-22

    Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. ChiCTR-IOR-15006971. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian

    2006-01-01

    Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...

  10. Blood glucose level and outcome after cardiac arrest: insights from a large registry in the hypothermia era.

    Science.gov (United States)

    Daviaud, Fabrice; Dumas, Florence; Demars, Nadège; Geri, Guillaume; Bouglé, Adrien; Morichau-Beauchant, Tristan; Nguyen, Yên-Lan; Bougouin, Wulfran; Pène, Frédéric; Charpentier, Julien; Cariou, Alain

    2014-06-01

    The influence of blood glucose (BG) level during the post-resuscitation period after out-of-hospital cardiac arrest (OHCA) is still debated. To evaluate the relationship between blood glucose level and outcome, we included the median glycemia and its maximal amplitude over the first 48 h following ICU admission in an analysis of outcome predictors. We conducted a database study in a cardiac arrest center in Paris, France. Between 2006 and 2010, we included 381 patients who were all resuscitated from an OHCA. A moderate glycemic control was applied in all patients. The median glycemia and the largest change over the first 48 h were included in a multivariate analysis that was performed to determine parameters associated with a favorable outcome. Of the 381 patients, 136 (36 %) had a favorable outcome (CPC 1-2). Median BG level was 7.6 mmol/L (6.3-9.8) in patients with a favorable outcome compared to 9.0 mmol/L (IQR 7.1-10.6) for patients with an unfavorable outcome (p level variation was 7.1 (4.2-11) and 9.6 (5.9-13.6) mmol/L in patients with and without a favorable outcome, respectively (p level over the first 48 h was found to be an independent predictor of poor issue [OR = 0.43; 95 % CI (0.24-0.78), p = 0.006]. Finally a progressive increase in median BG level was associated with a progressive increase in the proportion of patients with a poor outcome. We observed a relationship between high blood glucose level and outcome after cardiac arrest. These results suggest the need to test a strategy combining both control of glycemia and minimization of glycemic variations for its ability to improve post-resuscitation care.

  11. Referral to Cardiac Rehabilitation After Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, and Valve Surgery: Data From the Clinical Outcomes Assessment Program.

    Science.gov (United States)

    Beatty, Alexis L; Bradley, Steven M; Maynard, Charles; McCabe, James M

    2017-06-01

    Despite guideline recommendations that patients undergoing percutaneous coronary intervention (PCI), coronary artery bypass surgery, or valve surgery be referred to cardiac rehabilitation, cardiac rehabilitation is underused. The objective of this study was to examine hospital-level variation in cardiac rehabilitation referral after PCI, coronary artery bypass surgery, and valve surgery. We analyzed data from the Clinical Outcomes Assessment Program, a registry of all nonfederal hospitals performing PCI and cardiac surgery in Washington State. We included eligible PCI, coronary artery bypass surgery, and valve surgery patients from 2010 to 2015. We analyzed PCI and cardiac surgery separately by performing multivariable hierarchical logistic regression for the outcome of cardiac rehabilitation referral at discharge, clustered by hospital. Patient-level covariates included age, sex, race/ethnicity, comorbidities, and procedure indication/status. Cardiac rehabilitation referral was reported in 48% (34 047/71 556) of PCI patients and 91% (21 831/23 972) of cardiac surgery patients. The hospital performing the procedure was a stronger predictor of referral than any individual patient characteristic for PCI (hospital referral range 3%-97%; median odds ratio, 5.94; 95% confidence interval, 4.10-9.49) and cardiac surgery (range 54%-100%; median odds ratio, 7.09; 95% confidence interval, 3.79-17.80). Hospitals having an outpatient cardiac rehabilitation program explained only 10% of PCI variation and 0% of cardiac surgery variation. Cardiac rehabilitation referral at discharge was less prevalent after PCI than cardiac surgery. The strongest predictor of cardiac rehabilitation referral was the hospital performing the procedure. Efforts to improve cardiac rehabilitation referral should focus on increasing referral after PCI, especially in low referral hospitals. © 2017 American Heart Association, Inc.

  12. Prospective randomized controlled intervention trial: Comprehensive Yogic Breathing Improves Cardiac autonomic functions and Quality of life in Diabetes

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2012-01-01

    Full Text Available Aims and Objectives: To assess the effect of Comprehensive Yogic Breathing Program on glycemic control, quality of life, and cardiac autonomic functions in diabetes. Material and Methods: This is a prospective randomized controlled intervention trial. Cardiac autonomic functions were assessed in 120 diabetics. Patients were randomized into two groups, one group receiving standard therapy for diabetes (n = 56 and the other group receiving standard therapy for diabetes and comprehensive yogic breathing program (n = 64. Standard therapy included advice on diet, walk, and oral antidiabetic drugs. Comprehensive yogic breathing program was an interactive session in which Sudarshan kriya yoga, a rhythmic cyclical breathing, preceded by Pranayam was taught under guidance of a certified teacher. Change in fasting, post prandial blood sugars, glycated hemoglobin, and quality of life were assessed. Cardiac autonomic function tests were done before and six months after intervention. Results: There was significant improvement in psychological (P = 0.006 and social domains (P = 0.04 and total quality of life (P = 0.02 in the group practicing comprehensive yogic breathing program as compared to the group following standard therapy alone. In the group following breathing program, the improvement in sympathetic cardiac autonomic functions was statistically significant (P = 0.01, while the change in the standard group was not significant (P = 0.17. When both parasympathetic and sympathetic cardiac autonomic functions were considered, there was a trend toward improvement in patients following comprehensive yogic breathing program (P = 0.07. In the standard therapy group, no change in cardiac autonomic functions was noted (P = 0.76. The parameters of glycemic control were comparable in both groups. Conclusion: There was significant improvement in quality of life and cardiac autonomic functions in the diabetes patients practicing comprehensive yogic breathing

  13. Pneumonia After Cardiac Surgery: Experience of the NIH/CIHR Cardiothoracic Surgical Trials Network

    Science.gov (United States)

    Ailawadi, Gorav; Chang, Helena L.; O’Gara, Patrick T.; O'sullivan, Karen; Woo, Y. Joseph; DeRose, Joseph J.; Parides, Michael K.; Thourani, Vinod H.; Robichaud, Sophie; Gillinov, A. Marc; Taddei-Peters, Wendy C.; Miller, Marissa A.; Perrault, Louis P.; Smith, Robert L.; Goldsmith, Lyn; Horvath, Keith A.; Doud, Kristen; Baio, Kim; Gelijns, Annetine C.; Moskowitz, Alan J.; Bagiella, Emilia; Alexander, John H.; Iribarne, Alexander

    2017-01-01

    Rationale Pneumonia remains the most common major infection after cardiac surgery despite numerous preventive measures. Objectives To prospectively examine the timing, pathogens, and risk factors, including modifiable management practices, for post-operative pneumonia and estimate its impact on clinical outcomes. Methods 5,158 adult cardiac surgery patients were prospectively enrolled in a cohort study across 10 centers. All infections were adjudicated by an independent committee. Competing risk models were used to assess the association of patient characteristics and management practices with pneumonia within 65 days of surgery. Mortality was assessed by Cox proportional hazards model, and length of stay using a multi-state model. Measurements and Main Results The cumulative incidence of p neumonia was 2.4% ,33% of which occurred after discharge. Older age, lower hemoglobin level, chronic obstructive pulmonary disease, steroid use, operative time and left ventricular assist device/heart transplant were risk factors. Ventilation time (24–48 vs ≤24 hours;HR,2·83; 95% CI,1·72–4·66; >48 hours HR,4·67; 95% CI,2·70–8·08), nasogastric tubes (HR,1·80; 95% CI,1·10–2·94), and each unit of blood cells transfused (HR,1·16; 95% CI,1·08–1·26) increased pneumonia risk. Prophylactic use of second-generation cephalosporins (HR,0·66; 95% CI, 0·45–0·97) and platelet transfusions (HR, 0·49, 95% CI, 0·30–0·79) were protective. Pneumonia was associated with a marked increase in mortality (HR,8·89; 95% CI,5·02–15·75), and longer LOS of 13·55 ± 1·95 days (bootstrap 95% CI,10·31–16·58). Conclusions Pneumonia continues to impose a major impact on the health of patients after cardiac surgery. Adjusting for baseline risk, several specific management practices were associated with pneumonia, which offer targets for quality improvement and further research. PMID:28341473

  14. Referrals in acute coronary events for CARdiac catheterization: The RACE CAR trial.

    Science.gov (United States)

    Kreatsoulas, Catherine; Sloane, Debi; Pogue, Janice; Velianou, James L; Anand, Sonia S

    2010-10-01

    Women with acute coronary syndromes have lower rates of cardiac catheterization (CC) than men. To determine whether sex⁄gender, age, risk level and patient preference influence physician decision making to refer patients for CC. Twelve clinical scenarios controlling for sex⁄gender, age (55 or 75 years of age), Thrombolysis in Myocardial Infarction risk score (low, moderate or high) and patient preference for CC (agreeable or refused⁄no preference expressed) were designed. Scenarios were administered to specialists across Canada using a web-based computerized survey instrument. Questions were standardized using a five-point Likert scale ranging from 1 (very unlikely to benefit from CC) to 5 (very likely to benefit from CC). Outcomes were assessed using a two-tailed mixed linear regression model. Of 237 scenarios, physicians rated men as more likely to benefit from CC than women (mean [± SE] 4.44±0.07 versus 4.25±0.07, P=0.03), adjusted for age, risk and patient preference. Low-risk men were perceived to benefit more than low-risk women (4.20±0.13 versus 3.54±0.14, Pno comment at all (5.0±0.23, 3.67±0.21, 2.95±0.14, respectively, P<0.01). Canadian specialists' decisions to refer patients for CC appear to be influenced by sex⁄gender, age and patient preference in clinical scenarios in which cardiac risk is held constant. Future investigation of possible age and sex⁄gender biases as proxies for risk is warranted.

  15. Collaborative care for depression and anxiety disorders in patients with recent cardiac events: the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized clinical trial.

    Science.gov (United States)

    Huffman, Jeff C; Mastromauro, Carol A; Beach, Scott R; Celano, Christopher M; DuBois, Christina M; Healy, Brian C; Suarez, Laura; Rollman, Bruce L; Januzzi, James L

    2014-06-01

    Depression and anxiety are associated with adverse cardiovascular outcomes in patients with recent acute cardiac events. There has been minimal study of collaborative care (CC) management models for mental health disorders in high-risk cardiac inpatients, and no prior CC intervention has simultaneously managed depression and anxiety disorders. To determine the impact of a low-intensity CC intervention for depression, generalized anxiety disorder, and panic disorder among patients hospitalized for an acute cardiac illness. Single-blind randomized clinical trial, with study assessors blind to group assignment, from September 2010 through July 2013 of 183 patients admitted to inpatient cardiac units in an urban academic general hospital for acute coronary syndrome, arrhythmia, or heart failure and found to have clinical depression, generalized anxiety disorder, or panic disorder on structured assessment. Participants were randomized to 24 weeks of a low-intensity telephone-based multicomponent CC intervention targeting depression and anxiety disorders (n = 92) or to enhanced usual care (serial notification of primary medical providers; n = 91). The CC intervention used a social work care manager to coordinate assessment and stepped care of psychiatric conditions and to provide support and therapeutic interventions as appropriate. Improvement in mental health-related quality of life (Short Form-12 Mental Component Score [SF-12 MCS]) at 24 weeks, compared between groups using a random-effects model in an intent-to-treat analysis. Patients randomized to CC had significantly greater estimated mean improvements in SF-12 MCS at 24 weeks (11.21 points [from 34.21 to 45.42] in the CC group vs 5.53 points [from 36.30 to 41.83] in the control group; estimated mean difference, 5.68 points [95% CI, 2.14-9.22]; P = .002; effect size, 0.61). Patients receiving CC also had significant improvements in depressive symptoms and general functioning, and higher rates of

  16. Development of a diagnosis- and procedure-based risk model for 30-day outcome after pediatric cardiac surgery.

    Science.gov (United States)

    Crowe, Sonya; Brown, Kate L; Pagel, Christina; Muthialu, Nagarajan; Cunningham, David; Gibbs, John; Bull, Catherine; Franklin, Rodney; Utley, Martin; Tsang, Victor T

    2013-05-01

    The study objective was to develop a risk model incorporating diagnostic information to adjust for case-mix severity during routine monitoring of outcomes for pediatric cardiac surgery. Data from the Central Cardiac Audit Database for all pediatric cardiac surgery procedures performed in the United Kingdom between 2000 and 2010 were included: 70% for model development and 30% for validation. Units of analysis were 30-day episodes after the first surgical procedure. We used logistic regression for 30-day mortality. Risk factors considered included procedural information based on Central Cardiac Audit Database "specific procedures," diagnostic information defined by 24 "primary" cardiac diagnoses and "univentricular" status, and other patient characteristics. Of the 27,140 30-day episodes in the development set, 25,613 were survivals, 834 were deaths, and 693 were of unknown status (mortality, 3.2%). The risk model includes procedure, cardiac diagnosis, univentricular status, age band (neonate, infant, child), continuous age, continuous weight, presence of non-Down syndrome comorbidity, bypass, and year of operation 2007 or later (because of decreasing mortality). A risk score was calculated for 95% of cases in the validation set (weight missing in 5%). The model discriminated well; the C-index for validation set was 0.77 (0.81 for post-2007 data). Removal of all but procedural information gave a reduced C-index of 0.72. The model performed well across the spectrum of predicted risk, but there was evidence of underestimation of mortality risk in neonates undergoing operation from 2007. The risk model performs well. Diagnostic information added useful discriminatory power. A future application is risk adjustment during routine monitoring of outcomes in the United Kingdom to assist quality assurance. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  17. [Cardiac surgery in octogenarian patients: evaluation of predictive factors of mortality, long-term outcome and quality of life].

    Science.gov (United States)

    Viana-Tejedor, Ana; Domínguez, Francisco J; Moreno Yangüela, Mar; Moreno, Raúl; López de Sá, Esteban; Mesa, José M; López-Sendón, José

    2008-10-04

    Increasing life expectancy in Western countries in the last decades has resulted in a significant gradual increasing number of octogenarians referred for cardiac surgery. There is a need for a critical evaluation of the long-term surgical outcome and quality of life in the elderly. The aim of this study is to identify risk factors of mortality in octogenarians undergoing cardiac surgery and to assess the long term survival and quality of life. Data were reviewed on 150 patients aged over 80 years--mean age (standard deviation): 82.7 (2.5) years--who underwent cardiac surgery at our institution in the last 26 years. We analyzed clinical and epidemiological variables included in the European System for Cardiac Operative Risk Evaluation (euroSCORE), in-hospital morbidity and mortality, long term survival and quality of life after cardiac surgery. The 30-day mortality rate was 30.1%, with a mean hospital stay of 16.5 days (13-27). Emergent procedure, reparation of postinfarction ventricular ruptures, New York Heart Association functional class IV, chronic renal failure and previous myocardial infarction were independent predictors of in-hospital mortality. Mean follow up was 72.2 (9.9) months with survival rates of 87.3% and 57% at 1 and 5 years, respectively. Late postoperative quality of life in our 53 long-term survivors was significantly better than prior to surgery. New York Heart Association functional class improved from 2.52 to 1.48. Most survivors (97.7%) were satisfied with present quality of life Cardiac surgery in octogenarians is associated with increased in-hospital mortality rate and longer hospital stay. Our findings support that cardiac surgery can be performed in a selected elderly population with good long-term survival and quality of life.

  18. Age × Gender Interaction Effect on Resuscitation Outcomes in Patients With Out-of-Hospital Cardiac Arrest.

    Science.gov (United States)

    Hagihara, Akihito; Onozuka, Daisuke; Ono, Junko; Nagata, Takashi; Hasegawa, Manabu

    2017-08-01

    Although an interaction between gender and age has been shown to influence resuscitation outcomes in patients with out-of-hospital cardiac arrest (OHCA), this interaction has not been investigated in Asian populations. In this prospective, observational study, data from all cases of OHCA in Japan between 2005 and 2012 were obtained from the Japanese National Registry. We determined the relative excess risk due to interaction and the ratio of odds ratios (ORs) to assess the interaction effect of gender and age on the incidence of return of spontaneous circulation (ROSC) before hospital arrival, 1-month survival, and neurologically intact survival 1 month after OHCA. Male gender was associated with decreased ROSC and lower 1-month survival rates in patients with OHCA of presumed cardiac origin. Older age was associated with lower 1-month and neurologically intact survival rates in male patients with OHCA of presumed cardiac and noncardiac origin and with increased ROSC in male patients with OHCA of presumed cardiac origin. The relative excess risk due to interaction for ROSC in patients with OHCA of presumed cardiac origin was statistically significant (OR 0.19, 95% confidence interval [CI] 0.06 to 0.32). The ratio of ORs for ROSC was statistically significant in patients with OHCA of presumed cardiac origin (OR 1.25, 95% CI 1.05 to 1.47) and of noncardiac origin (OR 0.40, 95% CI 0.17 to 0.92). In conclusion, the interaction effect between age and gender on ROSC was positive in OHCA cases of presumed cardiac origin and negative in those of noncardiac origin. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Influence of argon on temperature modulation and neurological outcome in hypothermia treated rats following cardiac arrest.

    Science.gov (United States)

    Brücken, Anne; Bleilevens, Christian; Föhr, Philipp; Nolte, Kay; Rossaint, Rolf; Marx, Gernot; Fries, Michael; Derwall, Matthias

    2017-08-01

    Combining xenon and mild therapeutic hypothermia (MTH) after cardiac arrest (CA) confers a degree of protection that is greater than either of the two interventions alone. However, xenon is very costly which might preclude a widespread use. We investigated whether the inexpensive gas argon would enhance hypothermia induced neurologic recovery in a similar manner. Following nine minutes of CA and three minutes of cardiopulmonary resuscitation 21 male Sprague-Dawley rats were randomized to receive MTH (33°C for 6h), MTH plus argon (70% for 1h), or no treatment. A first day condition score assessed behaviour, motor activity and overall condition. A neurological deficit score (NDS) was calculated daily for seven days following the experiment before the animals were killed and the brains harvested for histopathological analysis. All animals survived. Animals that received MTH alone showed best overall neurologic function. Strikingly, this effect was abolished in the argon-augmented MTH group, where animals showed worse neurologic outcome being significant in the first day condition score and on day one to three and five in the NDS in comparison to MTH treated rats. Results were reflected by the neurohistopathological analysis. Our study demonstrates that argon augmented MTH does not improve functional recovery after CA in rats, but may even worsen neurologic function in this model. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Perioperative Rosuvastatin in Cardiac Surgery.

    Science.gov (United States)

    Zheng, Zhe; Jayaram, Raja; Jiang, Lixin; Emberson, Jonathan; Zhao, Yan; Li, Qi; Du, Juan; Guarguagli, Silvia; Hill, Michael; Chen, Zhengming; Collins, Rory; Casadei, Barbara

    2016-05-05

    Complications after cardiac surgery are common and lead to substantial increases in morbidity and mortality. Meta-analyses of small randomized trials have suggested that perioperative statin therapy can prevent some of these complications. We randomly assigned 1922 patients in sinus rhythm who were scheduled for elective cardiac surgery to receive perioperative rosuvastatin (at a dose of 20 mg daily) or placebo. The primary outcomes were postoperative atrial fibrillation within 5 days after surgery, as assessed by Holter electrocardiographic monitoring, and myocardial injury within 120 hours after surgery, as assessed by serial measurements of the cardiac troponin I concentration. Secondary outcomes included major in-hospital adverse events, duration of stay in the hospital and intensive care unit, left ventricular and renal function, and blood biomarkers. The concentrations of low-density lipoprotein cholesterol and C-reactive protein after surgery were lower in patients assigned to rosuvastatin than in those assigned to placebo (PSTICS ClinicalTrials.gov number, NCT01573143.).

  1. Revisiting blood transfusion and predictors of outcome in cardiac surgery patients: a concise perspective [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Carlos E Arias-Morales

    2017-02-01

    Full Text Available In the United States, cardiac surgery-related blood transfusion rates reached new highs in 2010, with 34% of patients receiving blood products. Patients undergoing both complex (coronary artery bypass grafting [CABG] plus valve repair or replacement and non-complex (isolated CABG cardiac surgeries are likely to have comorbidities such as anemia. Furthermore, the majority of patients undergoing isolated CABG have a history of myocardial infarction. These characteristics may increase the risk of complications and blood transfusion requirement. It becomes difficult to demonstrate the association between transfusions and mortality because of the fact that most patients undergoing cardiac surgery are also critically ill. Transfusion rates remain high despite the advances in perioperative blood conservation, such as the intraoperative use of cell saver in cardiac surgery. Some recent prospective studies have suggested that the use of blood products, even in low-risk patients, may adversely affect clinical outcomes. In light of this information, we reviewed the literature to assess the clinical outcomes in terms of 30-day and 1-year morbidity and mortality in transfused patients who underwent uncomplicated CABG surgery.

  2. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery

    DEFF Research Database (Denmark)

    Mazer, C David; Whitlock, Richard P; Fergusson, Dean A

    2017-01-01

    BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear. METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a E...

  3. Association of public health initiatives with outcomes for out-of-hospital cardiac arrest at home and in public locations

    DEFF Research Database (Denmark)

    Christopher B., Fordyce; Carolina M., Hansen; Kragholm, Kristian

    2017-01-01

    Importance  Little is known about the influence of comprehensive public health initiatives according to out-of-hospital cardiac arrest (OHCA) location, particularly at home, where resuscitation efforts and outcomes have historically been poor.Objective  To describe temporal trends in bystander...... cardiopulmonary resuscitation (CPR) and first-responder defibrillation for OHCAs stratified by home vs public location and their association with survival and neurological outcomes.Design, Setting, and Participants  This observational study reviewed 8269 patients with OHCAs (5602 [67.7%] at home and 2667 [32.......3%] in public) for whom resuscitation was attempted using data from the Cardiac Arrest Registry to Enhance Survival (CARES) from January 1, 2010, through December 31, 2014. The setting was 16 counties in North Carolina.Exposures  Patients were stratified by home vs public OHCA. Public health initiatives...

  4. Core domain and outcome measurement sets for shoulder pain trials are needed: Systematic review of physical therapy trials

    NARCIS (Netherlands)

    M.J. Page (Matthew J.); J.E. McKenzie (Joanne E.); S.E. Green (Sally E.); D.E. Beaton (Dorcas E.); N.B. Jain (Nitin B.); M. Lenza (Mario); A.P. Verhagen (Arianne); S. Surace (Stephen); J. Deitch (Jessica); R. Buchbinder (Rachelle)

    2015-01-01

    textabstractObjectives To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain). Study Design and Setting We included

  5. Impact of Tight Glycemic Control on Neurodevelopmental Outcomes at 1 Year of Age for Children with Congenital Heart Disease: A Randomized Controlled Trial

    Science.gov (United States)

    Sadhwani, Anjali; Asaro, Lisa A.; Goldberg, Caren; Ware, Janice; Butcher, Jennifer; Gaies, Michael; Smith, Cynthia; Alexander, Jamin L.; Wypij, David; Agus, Michael S. D.

    2016-01-01

    Objective To assess the association of postoperative tight glycemic control and hypoglycemia in children undergoing cardiac surgery with neurodevelopmental outcomes at 1 year of age. Study design A 2-center, prospective, randomized trial of postoperative tight glycemic control vs standard care was conducted in 980 children undergoing cardiac surgery. Neurodevelopmental outcomes were assessed at nine to 18 months using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Adaptive Behavior Assessment System, Second Edition, the Ages and Stages Questionnaire, Third Edition, and the Brief Infant Toddler Social-Emotional Assessment. Results Neurodevelopmental follow-up was performed on 237 patients with a mean age of 13 months. No significant treatment group differences were found in the Bayley-III and Adaptive Behavior Assessment System, Second Edition composite scores or percentage at risk based on the Ages and Stages Questionnaire, Third Edition and the Brief Infant Toddler Social-Emotional Assessment. Patients who experienced moderate to severe hypoglycemia (n = 8) had lower Bayley-III composite scores compared with patients with no to mild hypoglycemia, even after controlling for factors known to be associated with poorer neurodevelopmental outcomes. Conclusion For infants undergoing cardiac surgery, tight glycemic control did not impact neurodevelopmental outcomes compared with standard care. These data suggest a possible association between moderate to severe hypoglycemia and poorer neurodevelopmental outcomes at 1 year of age. PMID:27112038

  6. Web-based nursing intervention for self-management of pain after cardiac surgery: pilot randomized controlled trial.

    Science.gov (United States)

    Martorella, Géraldine; Côté, José; Racine, Mélanie; Choinière, Manon

    2012-12-14

    Most adults undergoing cardiac surgery suffer from moderate to severe pain for up to 6 days after surgery. Individual barriers and attitudes regarding pain and its relief make patients reluctant to report their pain and ask for analgesic medication, which results in inadequate pain management. More innovative educational interventions for postoperative pain relief are needed. We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE-TAVIE) includes a preoperative 30-minute Web-based session and 2 brief face-to-face postoperative booster sessions. The Web application generates reflective activities and tailored educational messages according to patients' beliefs and attitudes. The messages are transmitted through videos of a virtual nurse, animations, stories, and texts. The aim of this single-blinded pilot randomized trial was to investigate the preliminary effects of a virtual nursing intervention (SOULAGE-TAVIE) to improve pain relief in patients undergoing cardiac surgery. Participants (N = 60) were adults scheduled for their first cardiac surgery. They were randomly assigned to the experimental group using SOULAGE-TAVIE (n = 30) or the control group using usual care, including an educational pamphlet and postoperative follow-up (n = 30). Data were collected through questionnaires at the time of admission and from day 1 to day 7 after surgery with the help of a blinded research assistant. Outcomes were pain intensity, pain interference with daily activities, patients' pain barriers, tendency to catastrophize in face of pain, and analgesic consumption. The two groups were comparable at baseline across all demographic measures. Results revealed that patients in the experimental group did not experience less intense pain, but they reported significantly less pain interference when breathing/coughing (P = .04). A severe pain interference with breathing/coughing (pain ranked ≥ 7

  7. Registration status and outcome reporting of trials published in core headache medicine journals.

    Science.gov (United States)

    Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

    2015-11-17

    To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

  8. Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis

    DEFF Research Database (Denmark)

    Heiligenhaus, Arnd; Foeldvari, Ivan; Edelsten, Clive

    2012-01-01

    To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis.......To develop a set of core outcome measures for use in randomized controlled trials (RCTs) and longitudinal observational studies in juvenile idiopathic arthritis (JIA)-associated uveitis....

  9. The Efficacy of Goal Setting in Cardiac Rehabilitation-a Gender-Specific Randomized Controlled Trial.

    Science.gov (United States)

    Stamm-Balderjahn, Sabine; Brünger, Martin; Michel, Anne; Bongarth, Christa; Spyra, Karla

    2016-08-08

    Patients with coronary heart disease undergo cardiac rehabilitation in order to reduce their cardiovascular risk factors. Often, however, the benefit of rehabilitation is lost over time. It is unclear whether this happens in the same way to men and women. We studied whether the setting of gender-specific behavior goals with an agreement between the doctor and the patient at the end of rehabilitation can prolong its positive effects. This study was performed with a mixed-method design. It consisted of qualitative interviews and group discussions with patients, doctors and other treating personnel, and researchers, as well as a quantitative, randomized, controlled intervention trial in which data were acquired at four time points (the beginning and end of rehabilitation and then 6 and 12 months later). 545 patients, 262 of them women (48.1%), were included. The patients were assigned to a goal checking group (n = 132), a goal setting group (n = 143), and a control group (n = 270). The primary endpoints were health-related behavior (exercise, diet, tobacco consumption), subjective state of health, and medication adherence. The secondary endpoints included physiological protection and risk factors such as blood pressure, cholesterol (HDL, LDL, and total), blood sugar, HbA1c, and body-mass index. The intervention had no demonstrable effect on the primary or secondary endpoints. The percentage of smokers declined to a similar extent in all groups from the beginning of rehabilitation to 12 months after its end (overall figures: 12.4% to 8.6%, p exercise behavior, diet, and subjective state of health also improved over the entire course of the study. Women had a healthier diet than men. Subgroup analyses indicated a possible effect of the intervention on exercise behavior in women who were employed and in men who were not (pgoal setting was not demonstrated. Therefore, no indication for its routine provision can be derived from the study results.

  10. Impact of Bystander Automated External Defibrillator Use on Survival and Functional Outcomes in Shockable Observed Public Cardiac Arrests.

    Science.gov (United States)

    Pollack, Ross A; Brown, Siobhan P; Rea, Thomas; Aufderheide, Tom; Barbic, David; Buick, Jason E; Christenson, James; Idris, Ahamed H; Jasti, Jamie; Kampp, Michael; Kudenchuk, Peter; May, Susanne; Muhr, Marc; Nichol, Graham; Ornato, Joseph P; Sopko, George; Vaillancourt, Christian; Morrison, Laurie; Weisfeldt, Myron

    2018-02-26

    Background - Survival following out-of-hospital cardiac arrest (OHCA) with shockable rhythms can be improved with early defibrillation. Although shockable OHCA accounts for only ≈25% of overall arrests, ≈60% of public OHCAs are shockable, offering the possibility of restoring thousands of individuals to full recovery with early defibrillation by bystanders. We sought to determine the association of bystander automated external defibrillator use with survival and functional outcomes in shockable observed public OHCA. Methods - From 2011 to 2015, the Resuscitation Outcomes Consortium prospectively collected detailed information on all cardiac arrests at 9 regional centers. The exposures were shock administration by a bystander-applied automated external defibrillator in comparison with initial defibrillation by emergency medical services. The primary outcome measure was discharge with normal or near-normal (favorable) functional status defined as a modified Rankin Score ≤2. Survival to hospital discharge was the secondary outcome measure. Results -Among 49 555 OHCAs, 4115 (8.3%) observed public OHCAs were analyzed, of which 2500 (60.8%) were shockable. A bystander shock was applied in 18.8% of the shockable arrests. Patients shocked by a bystander were significantly more likely to survive to discharge (66.5% versus 43.0%) and be discharged with favorable functional outcome (57.1% versus 32.7%) than patients initially shocked by emergency medical services. After adjusting for known predictors of outcome, the odds ratio associated with a bystander shock was 2.62 (95% confidence interval, 2.07-3.31) for survival to hospital discharge and 2.73 (95% confidence interval, 2.17-3.44) for discharge with favorable functional outcome. The benefit of bystander shock increased progressively as emergency medical services response time became longer. Conclusions - Bystander automated external defibrillator use before emergency medical services arrival in shockable observed

  11. A general method for handling missing binary outcome data in randomized controlled trials

    OpenAIRE

    Jackson, Dan; White, Ian R; Mason, Dan; Sutton, Stephen

    2014-01-01

    Aims The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes. Design We propose a sensitivity analysis where standard analyses, which could include ‘missing = smoking’ and ‘last observation carried forward’, are embedded in a wider class of models. Setting We apply our general method to data from two smoking cessation trials. Partici...

  12. A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly: Design of the EU-CaRE randomised controlled trial.

    Science.gov (United States)

    Prescott, Eva; Meindersma, Esther P; van der Velde, Astrid E; Gonzalez-Juanatey, Jose R; Iliou, Marie Christine; Ardissino, Diego; Zoccai, Giuseppe Biondi; Zeymer, Uwe; Prins, Leonie F; Van't Hof, Arnoud Wj; Wilhelm, Matthias; de Kluiver, Ed P

    2016-10-01

    Cardiac rehabilitation (CR) is an evidence-based intervention to increase survival and quality of life. Yet studies consistently show that elderly patients are less frequently referred to CR, show less uptake and more often drop out of CR programmes. The European study on effectiveness and sustainability of current cardiac rehabilitation programmes in the elderly (EU-CaRE) project consists of an observational study and an open prospective, investigator-initiated multicentre randomised controlled trial (RCT) involving mobile telemonitoring guided CR (mCR). The aim of EU-CaRE is to map the efficiency of current CR of the elderly in Europe, and to investigate whether mCR is an effective alternative in terms of efficacy, adherence and sustainability. The EU-CaRE study includes patients aged 65 years or older with ischaemic heart disease or who have undergone heart valve surgery. A total of 1760 patients participating in existing CR programmes in eight regions of Europe will be included. Of patients declining regular CR, 238 will be included in the RCT and randomised in two study arms. The experimental group (mCR) will receive a personalised home-based programme while the control group will receive no advice or coaching throughout the study period. Outcomes will be assessed after the end of CR and at 12 months follow-up. The primary outcome is VO 2peak and secondary outcomes include variables describing CR uptake, adherence, efficacy and sustainability. The study will provide important information to improve CR in the elderly. The EU-CaRE RCT is the first European multicentre study of mCR as an alternative for elderly patients not attending usual CR. © The European Society of Cardiology 2016.

  13. Cardiac output-based fluid optimization for kidney transplant recipients: a proof-of-concept trial.

    Science.gov (United States)

    Corbella, Davide; Toppin, Patrick Jason; Ghanekar, Anand; Ayach, Nour; Schiff, Jeffery; Van Rensburg, Adrian; McCluskey, Stuart A

    2018-04-10

    Intravenous fluid management for deceased donor kidney transplantation is an important, modifiable risk factor for delayed graft function (DGF). The primary objective of this study was to determine if goal-directed fluid therapy using esophageal Doppler monitoring (EDM) to optimize stroke volume (SV) would alter the amount of fluid given. This randomized, proof-of-concept trial enrolled 50 deceased donor renal transplant recipients. Data collected included patient characteristics, fluid administration, hemodynamics, and complications. The EDM was used to optimize SV in the EDM group. In the control group, fluid management followed the current standard of practice. The groups were compared for the primary outcome of total intraoperative fluid administered. There was no difference in the mean (standard deviation) volume of intraoperative fluid administered to the 24 control and 26 EDM patients [2,307 (750) mL vs 2,675 (842) mL, respectively; mean difference, 368 mL; 95% confidence interval (CI), - 87 to + 823; P = 0.11]. The incidence of complications in the control and EDM groups was similar (15/24 vs 17/26, respectively; P = 0.99), as was the incidence of delayed graft failure (8/24 vs 11/26, respectively; P = 0.36). Goal-directed fluid therapy did not alter the volume of fluid administered or the incidence of complications. This proof-of-concept trial provides needed data for conducting a larger trial to determine the influence of fluid therapy on the incidence in DGF in deceased donor kidney transplantation. www.clinicaltrials.gov (NCT02512731). Registered 31 July 2015.

  14. An Internet- and mobile-based tailored intervention to enhance maintenance of physical activity after cardiac rehabilitation: short-term results of a randomized controlled trial.

    Science.gov (United States)

    Antypas, Konstantinos; Wangberg, Silje C

    2014-03-11

    An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits, including decreased mortality. Internet- and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation. One component related to the efficacy of these interventions is tailoring of the content to the individual. Our trial assessed the effect of a longitudinally tailored Internet- and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay. We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version. The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone. The participants were randomized in monthly clusters to a tailored or nontailored (control) intervention group. All participants had access to a website with information regarding cardiac rehabilitation, an online discussion forum, and an online activity calendar. Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages. The main outcome was self-reported level of physical activity, which was obtained using an online international physical activity questionnaire at baseline, at discharge, and at 1 month and 3 months after discharge from the cardiac rehabilitation program. Included in the study were 69 participants. One month after discharge, the tailored intervention group (n=10) had a higher median level of overall physical activity (median 2737.5, IQR 4200.2) than the control group (n=14, median 1650.0, IQR 2443.5), but the difference was not significant

  15. Effects of comprehensive cardiac rehabilitation on functional capacity and cardiovascular risk factors in Brazilians assisted by public health care: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gabriela S. S. Chaves

    Full Text Available ABSTRACT Background Cardiovascular Disease (CVD is the leading burden of disease worldwide. Moreover, CVD-related death rates are considered an epidemic in low- and middle-income countries (LMICs. Research shows that cardiac rehabilitation (CR participation reduces death and improves disability and quality of life. Given the growing epidemic of CVD in LMICs and the insufficient evidence about CR programs in these countries, a Randomized Control Trial (RCT in Latin America is warranted. Objective To investigate the effects of comprehensive CR on functional capacity and cardiovascular risk factors. Method The design is a single-blinded RCT with three parallel arms: comprehensive CR (exercise + education versus exercise-based CR versus wait-list control (no CR. The primary outcome will be measured by the Incremental Shuttle Walk Test. Secondary outcomes are risk factors (blood pressure, dyslipidemia, dysglycemia, body mass index and waist circumference; tertiary outcomes are heart health behaviors (exercise, medication adherence, diet, and smoking, knowledge, and depressive symptoms. The CR program is six months in duration. Participants randomized to exercise-based CR will receive 24 weeks of exercise classes. The comprehensive CR group will also receive 24 educational sessions, including a workbook. Every outcome will be assessed at baseline and 6-months later, and mortality will be ascertained at six months and one year. Conclusion This will be the first RCT to establish the effects of CR in Latin America. If positive, results will be used to promote broader implementation of comprehensive CR and patient access in the region and to inform a larger-scale trial powered for mortality.

  16. High-Target Versus Low-Target Blood Pressure Management During Cardiopulmonary Bypass to Prevent Cerebral Injury in Cardiac Surgery Patients: A Randomized Controlled Trial.

    Science.gov (United States)

    Vedel, Anne G; Holmgaard, Frederik; Rasmussen, Lars S; Langkilde, Annika; Paulson, Olaf B; Lange, Theis; Thomsen, Carsten; Olsen, Peter Skov; Ravn, Hanne Berg; Nilsson, Jens C

    2018-04-24

    Cerebral injury is an important complication after cardiac surgery with the use of cardiopulmonary bypass. The rate of overt stroke after cardiac surgery is 1% to 2%, whereas silent strokes, detected by diffusion-weighted magnetic resonance imaging, are found in up to 50% of patients. It is unclear whether a higher versus a lower blood pressure during cardiopulmonary bypass reduces cerebral infarction in these patients. In a patient- and assessor-blinded randomized trial, we allocated patients to a higher (70-80 mm Hg) or lower (40-50 mm Hg) target for mean arterial pressure by the titration of norepinephrine during cardiopulmonary bypass. Pump flow was fixed at 2.4 L·min -1 ·m -2 . The primary outcome was the total volume of new ischemic cerebral lesions (summed in millimeters cubed), expressed as the difference between diffusion-weighted imaging conducted preoperatively and again postoperatively between days 3 and 6. Secondary outcomes included diffusion-weighted imaging-evaluated total number of new ischemic lesions. Among the 197 enrolled patients, mean (SD) age was 65.0 (10.7) years in the low-target group (n=99) and 69.4 (8.9) years in the high-target group (n=98). Procedural risk scores were comparable between groups. Overall, diffusion-weighted imaging revealed new cerebral lesions in 52.8% of patients in the low-target group versus 55.7% in the high-target group ( P =0.76). The primary outcome of volume of new cerebral lesions was comparable between groups, 25 mm 3 (interquartile range, 0-118 mm 3 ; range, 0-25 261 mm 3 ) in the low-target group versus 29 mm 3 (interquartile range, 0-143 mm 3 ; range, 0-22 116 mm 3 ) in the high-target group (median difference estimate, 0; 95% confidence interval, -25 to 0.028; P =0.99), as was the secondary outcome of number of new lesions (1 [interquartile range, 0-2; range, 0-24] versus 1 [interquartile range, 0-2; range, 0-29] respectively; median difference estimate, 0; 95% confidence interval, 0-0; P =0

  17. Practice of mechanical ventilation in cardiac arrest patients and effects of targeted temperature management: A substudy of the targeted temperature management trial.

    Science.gov (United States)

    Harmon, Matthew B A; van Meenen, David M P; van der Veen, Annelou L I P; Binnekade, Jan M; Dankiewicz, Josef; Ebner, Florian; Nielsen, Niklas; Pelosi, Paolo; Schultz, Marcus J; Horn, Janneke; Friberg, Hans; Juffermans, Nicole P

    2018-05-12

    Mechanical ventilation practices in patients with cardiac arrest are not well described. Also, the effect of temperature on mechanical ventilation settings is not known. The aims of this study were 1) to describe practice of mechanical ventilation and its relation with outcome 2) to determine effects of different target temperatures strategies (33 °C versus 36 °C) on mechanical ventilation settings. This is a substudy of the TTM-trial in which unconscious survivors of a cardiac arrest due to a cardiac cause were randomized to two TTM strategies, 33 °C (TTM33) and 36 °C (TTM36). Mechanical ventilation data were obtained at three time points: 1) before TTM; 2) at the end of TTM (before rewarming) and 3) after rewarming. Logistic regression was used to determine an association between mechanical ventilation variables and outcome. Repeated-measures mixed modelling was performed to determine the effect of TTM on ventilation settings. Mechanical ventilation data was available for 567 of the 950 TTM patients. Of these, 81% was male with a mean (SD) age of 64 (12) years. At the end of TTM median tidal volume was 7.7 ml/kg predicted body weight (PBW)(6.4-8.7) and 60% of patients were ventilated with a tidal volume ≤ 8 ml/kg PBW. Median PEEP was 7.7cmH 2 O (6.4-8.7) and mean driving pressure was 14.6 cmH 2 O (±4.3). The median FiO 2 fraction was 0.35 (0.30-0.45). Multivariate analysis showed an independent relationship between increased respiratory rate and 28-day mortality. TTM33 resulted in lower end-tidal CO 2 (Pgroup = 0.0003) and higher alveolar dead space fraction (Pgroup = 0.003) compared to TTM36, while PCO 2 levels and respiratory minute volume were similar between groups. In the majority of the cardiac arrest patients, protective ventilation settings are applied, including low tidal volumes and driving pressures. High respiratory rate was associated with mortality. TTM33 results in lower end-tidal CO 2 levels and a higher alveolar dead

  18. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention.

    Science.gov (United States)

    Shorter, G W; Heather, N; Bray, Jeremy W; Giles, E L; Holloway, A; Barbosa, C; Berman, A H; O'Donnell, A J; Clarke, M; Stockdale, K J; Newbury-Birch, D

    2017-12-22

    The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI. ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

  19. Sutureless versus Conventional Aortic Valve Replacement: Outcomes in 70 High-Risk Patients Undergoing Concomitant Cardiac Procedures.

    Science.gov (United States)

    Hanedan, Muhammet Onur; Yuruk, Mehmet Ali; Parlar, Ali Ihsan; Ziyrek, Ugur; Arslan, Ali Kemal; Sayar, Ufuk; Mataraci, Ilker

    2018-02-01

    In elderly, high-risk surgical patients, sutureless aortic valve replacement (AVR) can often be an alternative to conventional AVR; shorter aortic cross-clamp and cardiopulmonary bypass times are the chief advantages. We compared the outcomes of sutureless AVR with those of conventional AVR in 70 elderly patients who underwent concomitant cardiac surgical procedures. We retrospectively analyzed the cases of 42 men and 28 women (mean age, 70.4 ± 10.3 yr; range, 34-93 yr) who underwent cardiac operations plus AVR with either a sutureless valve (group 1, n=38) or a conventional bioprosthetic or mechanical valve (group 2, n=32). Baseline patient characteristics were similar except for worse New York Heart Association functional status and the prevalence of diabetes mellitus in group 1. In group 1, the operative, cross-clamp, and cardiopulmonary bypass times were shorter (all P =0.001), postoperative drainage amounts were lower ( P =0.009), hospital stays were shorter ( P =0.004), and less red blood cell transfusion was needed ( P =0.037). Echocardiograms before patients' discharge from the hospital showed lower peak and mean aortic gradients in group 1 (mean transvalvular gradient, 8.4 ± 2.8 vs 12.2 ± 5.2 mmHg; P =0.012). We found that elderly, high-risk patients who underwent multiple cardiac surgical procedures and sutureless AVR had better hemodynamic outcomes and shorter ischemic times than did patients who underwent conventional AVR.

  20. Characteristics and outcome among patients suffering from out-of-hospital cardiac arrest: Factors associated with survival

    Directory of Open Access Journals (Sweden)

    Trpković S.

    2014-01-01

    Full Text Available The aim was to define factors associated with an improved outcome among patients suffering out-of-hospital cardiac arrest (OHCA using the Utstain style data collection. We examined 200 patients suffering from OHCA in a prospective study in a two years period. We determined survival from cardiac arrest (CA to discharge from hospital and the factors associated with survival. 78% of CA patients had a cardiac aetiology, 65% occurred at home, 3.7% received bystander CPR. 36% were found in VF/VT, 64% in asystole/PEA. 52% of patients were intubated in the field, survival to discharge from hospital was significantly higher among patients who were intubated in the field. The mean response time was 6.6 minutes. 66.7% of patients were given the shock after 4 minutes. 131 (65.5% were pronounced dead in the field, 69 patients were transported to the hospital. 53 (76.8% patients of them died during the transport or in the ED, 7 died after hospital admission and 9 survived to hospital discharge. Multivariate logistic regression analysis showed that variables significantly associated with survival to hospital discharge were: age, endotracheal intubation in the field and mean response time. The outcome of CPR was better in patients who were younger, who were intubated in the field and when the response time was shorter.

  1. Impact of the mother-nurse partnership programme on mother and infant outcomes in paediatric cardiac intensive care unit.

    Science.gov (United States)

    Uhm, Ju-Yeon; Kim, Hee Soon

    2018-04-04

    To identify the effects of a mother-nurse partnership programme based on the core components of information sharing, negotiation and participation in care. Specifically, we examined the programme's effects on parental satisfaction, parental self-efficacy, perceived partnership and anxiety, as well as infants' time to reach full oral feeding and length of postoperative hospital stay, following cardiac surgery on infants at a paediatric intensive care unit with a restrictive visiting policy. Quasi-experimental study. An analysis of covariance was used to investigate between-group differences while ensuring homogeneity. A paediatric cardiac ICU. Parental satisfaction, parental self-efficacy, perceived partnership and anxiety. Data from 37 and 36 mothers in the control and experimental groups respectively, were analysed. Compared with controls, experimental group mothers reported significantly higher parental satisfaction (F = 39.29, p partnership (F = 62.30, p < .001) and lower anxiety (F = 12.93, p < .001), upon transfer to the ward. Infant outcomes did not differ between the groups. This programme appears to facilitate collaboration between nurses and mothers and positively influences mothers' emotional and cognitive outcomes following infants' cardiac surgery. Copyright © 2018. Published by Elsevier Ltd.

  2. Effect of music therapy with emotional-approach coping on preprocedural anxiety in cardiac catheterization: a randomized controlled trial.

    Science.gov (United States)

    Ghetti, Claire M

    2013-01-01

    Individuals undergoing cardiac catheterization are likely to experience elevated anxiety periprocedurally, with highest anxiety levels occurring immediately prior to the procedure. Elevated anxiety has the potential to negatively impact these individuals psychologically and physiologically in ways that may influence the subsequent procedure. This study evaluated the use of music therapy, with a specific emphasis on emotional-approach coping, immediately prior to cardiac catheterization to impact periprocedural outcomes. The randomized, pretest/posttest control group design consisted of two experimental groups--the Music Therapy with Emotional-Approach Coping group [MT/EAC] (n = 13), and a talk-based Emotional-Approach Coping group (n = 14), compared with a standard care Control group (n = 10). MT/EAC led to improved positive affective states in adults awaiting elective cardiac catheterization, whereas a talk-based emphasis on emotional-approach coping or standard care did not. All groups demonstrated a significant overall decrease in negative affect. The MT/EAC group demonstrated a statistically significant, but not clinically significant, increase in systolic blood pressure most likely due to active engagement in music making. The MT/EAC group trended toward shortest procedure length and least amount of anxiolytic required during the procedure, while the EAC group trended toward least amount of analgesic required during the procedure, but these differences were not statistically significant. Actively engaging in a session of music therapy with an emphasis on emotional-approach coping can improve the well-being of adults awaiting cardiac catheterization procedures.

  3. The association of emergency department administration of sodium bicarbonate after out of hospital cardiac arrest with outcomes.

    Science.gov (United States)

    Chen, Yi-Chuan; Hung, Ming-Szu; Liu, Chia-Yen; Hsiao, Cheng-Ting; Yang, Yao-Hsu

    2018-03-05

    Sodium bicarbonate administration is mostly restricted to in-hospital use in Taiwan. This study was conducted to investigate the effect of sodium bicarbonate on outcomes among patients with out-of-hospital cardiac arrest (OHCA). This population-based study used a 16-year database to analyze the association between sodium bicarbonate administration for resuscitation in the emergency department (ED) and outcomes. All adult patients with OHCA were identified through diagnostic and procedure codes. The primary outcome was survival to hospital admission and secondary outcome was the rate of death within the first 30days of incidence of cardiac arrest. Cox proportional-hazards regression, logistic regression, and propensity analyses were conducted. Among 5589 total OHCA patients, 15.1% (844) had survival to hospital admission. For all patients, a positive association was noted between sodium bicarbonate administration during resuscitation in the ED and survival to hospital admission (adjusted odds ratio [OR]: 4.47; 95% confidence interval [CI]: 3.82-5.22, p<0.001). In propensity-matched patients, a positive association was also noted (adjusted OR, 4.61; 95% CI: 3.90-5.46, p<0.001). Among patients with OHCA in Taiwan, administration of sodium bicarbonate during ED resuscitation was significantly associated with an increased rate of survival to hospital admission. Copyright © 2018. Published by Elsevier Inc.

  4. Practice Variation in Single-Ventricle Patients Undergoing Elective Cardiac Catheterization: A Report from the Congenital Cardiac Catheterization Project on Outcomes (C3PO).

    Science.gov (United States)

    Goldstein, Bryan H; Holzer, Ralf J; Trucco, Sara M; Porras, Diego; Murphy, Joshua; Foerster, Susan R; El-Said, Howaida G; Beekman, Robert H; Bergersen, Lisa

    2016-01-01

    The objective of this study was to investigate variation in practice surrounding elective cardiac catheterization in patients with single-ventricle (SV) congenital heart disease. Patient and procedural characteristics and outcomes during SV catheterization were collected prospectively from eight centers using a web-based registry (Congenital Cardiac Catheterization Project on Outcomes). We attempted to identify a population of elective procedures by limiting the cohort in case type and timing. Cases were then stratified by stage of SV palliation (pre-bidirectional cavopulmonary anastomosis [pre-BCPA], pre-Fontan and post-Fontan) and limited by age. Subcohort analysis was performed by mode of airway management (assisted vs. spontaneous ventilation). Institutional variation was assessed. Between 2/2007 and 6/2010, 1459 (10.1%) of 14 467 cases in the registry met the inclusion and exclusion criteria, including 326 pre-BCPA, 571 pre-Fontan and 562 post-Fontan procedures. Median patient age was 0.4 (interquartile range 0.3, 0.5), 2.6 (1.0, 3.4) and 9.6 (5.2, 15.4) years and weight was 5.6 (4.8, 6.4), 12.2 (10.5, 14), and 26.3 (16.6, 51.8) kg in the pre-BCPA, pre-Fontan and post-Fontan cohorts, respectively. Cases were more commonly diagnostic in the pre-BCPA cohort (57%) whereas they were more commonly interventional in the pre-Fontan (69%) and post-Fontan (77%) cohorts. At least one adverse event (AE) occurred in 210 cases (14.4%) overall, including 20% of pre-BCPA, 11% of pre-Fontan and 14% of post-Fontan catheterizations. Mode of airway management was associated with statistically significant, but clinically small differences in hemodynamic measures in the pre- and post-Fontan cohorts, but not in the pre-BCPA group. Considerable practice variation exists across centers with variability in airway management, AE rate, case type, interventions performed and fluoroscopy time, in all SV cohorts. Elective catheterization in SV patients, frequently performed with

  5. Neighborhood characteristics, bystander automated external defibrillator use, and patient outcomes in public out-of-hospital cardiac arrest.

    Science.gov (United States)

    Andersen, Lars W; Holmberg, Mathias J; Granfeldt, Asger; Løfgren, Bo; Vellano, Kimberly; McNally, Bryan F; Siegerink, Bob; Kurth, Tobias; Donnino, Michael W

    2018-05-01

    Automated external defibrillators (AEDs) can be used by bystanders to provide rapid defibrillation for patients with out-of-hospital cardiac arrest (OHCA). Whether neighborhood characteristics are associated with AED use is unknown. Furthermore, the association between AED use and outcomes has not been well characterized for all (i.e. shockable and non-shockable) public OHCAs. We included public, non-911-responder witnessed OHCAs registered in the Cardiac Arrest Registry to Enhance Survival (CARES) between 2013 and 2016. The primary patient outcome was survival to hospital discharge with a favorable functional outcome. We first assessed the association between neighborhood characteristics and bystander AED use using logistic regression and then assessed the association between bystander AED use and patient outcomes in a propensity score matched cohort. 25,182 OHCAs were included. Several neighborhood characteristics, including the proportion of people living alone, the proportion of white people, and the proportion with a high-school degree or higher, were associated with bystander AED use. 5132 OHCAs were included in the propensity score-matched cohort. Bystander AED use was associated with an increased risk of a favorable functional outcome (35% vs. 25%, risk difference: 9.7% [95% confidence interval: 7.2%, 12.2%], risk ratio: 1.38 [95% confidence interval: 1.27, 1.50]). This was driven by increased favorable functional outcomes with AED use in patients with shockable rhythms (58% vs. 39%) but not in patients with non-shockable rhythms (10% vs. 10%). Specific neighborhood characteristics were associated with bystander AED use in OHCA. Bystander AED use was associated with an increase in favorable functional outcome. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

    Science.gov (United States)

    Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

    2017-10-01

    Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy

  7. Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation.

    Science.gov (United States)

    Gates, Simon; Lall, Ranjit; Quinn, Tom; Deakin, Charles D; Cooke, Matthew W; Horton, Jessica; Lamb, Sarah E; Slowther, Anne-Marie; Woollard, Malcolm; Carson, Andy; Smyth, Mike; Wilson, Kate; Parcell, Garry; Rosser, Andrew; Whitfield, Richard; Williams, Amanda; Jones, Rebecca; Pocock, Helen; Brock, Nicola; Black, John Jm; Wright, John; Han, Kyee; Shaw, Gary; Blair, Laura; Marti, Joachim; Hulme, Claire; McCabe, Christopher; Nikolova, Silviya; Ferreira, Zenia; Perkins, Gavin D

    2017-03-01

    Mechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA). Evaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA. Pragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression. Four UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR. Patients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged CPR groups [193/2819, 6.8%; adjusted odds ratio (OR) 0.86, 95% confidence interval (CI) 0.64 to 1.15]. Survival with a CPC score of 1 or 2 may have been worse in the LUCAS-2 group (adjusted OR 0.72, 95% CI 0.52 to 0.99). No serious adverse events were noted. The systematic review found no evidence of a survival advantage if mechanical chest compression was used. The health economic analysis showed that LUCAS-2 was dominated by manual chest compression. There was substantial non-compliance in the LUCAS-2 arm. For 272 out of 1652 patients (16.5%), mechanical

  8. Outcomes in a Community-Based Intensive Cardiac Rehabilitation Program: Comparison with Hospital-Based and Academic Programs.

    Science.gov (United States)

    Katzenberg, Charles; Silva, Edna; Young, M Jean; Gilles, Greg

    2018-04-13

    The purpose of this study was to test the hypothesis that a community-based intensive cardiac rehabilitation program could produce positive changes in risk factor profile and outcomes in an at-risk population. Participants seeking either primary or secondary coronary artery disease prevention voluntarily enrolled in the 12-week intensive cardiac rehabilitation program. Data were obtained at baseline and 6-12 months after completion of the program. A total of 142 individuals, mean age 69 years, completed the Heart Series between 2012 and 2016. Follow-up data were available in 105 participants (74%). Participants showed statistically significant improvements in mean weight (165 to 162 lbs, P = .0005), body mass index (26 to 25 kg/m 2 , P = .001), systolic blood pressure (126 to 122 mm Hg, P = .01), diastolic blood pressure (73 to 70 mm Hg, P = .0005), total cholesterol (175 to 168 mg/dL, P = .03), low-density lipoprotein cholesterol (LDL-C) (100 to 93 mg/dL, P = .005), LDL-C/high-density lipoprotein cholesterol (HDL-C) ratio (1.8 to 1.6, P = .005), and cholesterol/HDL-C ratio (3.2 to 3.0, P = .003). Changes in HDL-C, triglycerides, and fasting blood glucose did not reach statistical significance, but all trended in favorable directions. Adverse cardiovascular disease outcomes were rare (one stent placement, no deaths). A total of 105 participants completed our 12-week community-based intensive cardiac rehabilitation program and showed significant positive changes in several measures of cardiac risk, with only 1 adverse event. These results compare favorably with those of hospital-based and academic institutional programs. Copyright © 2018 Elsevier Inc. All rights reserved.

  9. Early Outcomes of Out-of-Hospital Cardiac Arrest after Early Defibrillation: a 24 Months Retrospective Analysis

    Directory of Open Access Journals (Sweden)

    Paolo Terranova

    2006-10-01

    Full Text Available Introduction: Cardiovascular disease remains the most common cause of death in the United States and most other Western nations. Among these deaths, sudden, out-of-hospital cardiac arrest claims approximately 1000 lives each day in the United States alone. Most of these cardiac arrests are due to ventricular fibrillation. Though highly reversible with the rapid application of a defibrillator, ventricular fibrillation is otherwise fatal within minutes, even when cardiopulmonary resuscitation is provided immediately. The overall survival rate in the United States is estimated to be less than 5 percent. Recent developments in automated-external-defibrillator technology have provided a means of increasing the rate of prompt defibrillation after out-of-hospital cardiac arrest. After minimal training, nonmedical personnel (e.g., flight attendants and casino workers are also able to use defibrillators in the workplace, with lifesaving effects. Nonetheless, such programs have involved designated personnel whose job description includes assisting persons who have had sudden cardiac arrest. Data are still lacking on the success of programs in which automated external defibrillators have been installed in public places to be used by persons who have no specific training or duty to act. Materials and Methods: All patients who had an out-of-hospital cardiac arrest between January 2003 and December 2004 and who received early defibrillation for ventricular fibrillation were included. We conducted a 24 months retrospective population-based analysis of the outcome in our population. Results: Over a 24 month period, 446 people had non–traumatic cardiac arrest, and in all of them it was observed to be ventricular fibrillation. In a very few cases, the defibrillator operators were good Samaritans, acting voluntarily. Eighty-nine patients (about 19% with ventricular fibrillation were successfully resuscitated, including eighteen who regained consciousness before

  10. Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine

    DEFF Research Database (Denmark)

    Liu, Jian-Ping; Han, Mei; Li, Xin-Xue

    2013-01-01

    Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.......Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications....

  11. Alternative research funding to improve clinical outcomes: model of prediction and prevention of sudden cardiac death.

    Science.gov (United States)

    Myerburg, Robert J; Ullmann, Steven G

    2015-04-01

    Although identification and management of cardiovascular risk markers have provided important population risk insights and public health benefits, individual risk prediction remains challenging. Using sudden cardiac death risk as a base case, the complex epidemiology of sudden cardiac death risk and the substantial new funding required to study individual risk are explored. Complex epidemiology derives from the multiple subgroups having different denominators and risk profiles, while funding limitations emerge from saturation of conventional sources of research funding without foreseeable opportunities for increases. A resolution to this problem would have to emerge from new sources of funding targeted to individual risk prediction. In this analysis, we explore the possibility of a research funding strategy that would offer business incentives to the insurance industries, while providing support for unresolved research goals. The model is developed for the case of sudden cardiac death risk, but the concept is applicable to other areas of the medical enterprise. © 2015 American Heart Association, Inc.

  12. The Effect of Threshold Values and Weighting Factors on the Association between Entropy Measures and Mortality after Myocardial Infarction in the Cardiac Arrhythmia Suppression Trial (CAST

    Directory of Open Access Journals (Sweden)

    Christopher Mayer

    2016-04-01

    Full Text Available Heart rate variability (HRV is a non-invasive measurement based on the intervals between normal heart beats that characterize cardiac autonomic function. Decreased HRV is associated with increased risk of cardiovascular events. Characterizing HRV using only moment statistics fails to capture abnormalities in regulatory function that are important aspects of disease risk. Thus, entropy measures are a promising approach to quantify HRV for risk stratification. The purpose of this study was to investigate this potential for approximate, corrected approximate, sample, fuzzy, and fuzzy measure entropy and its dependency on the parameter selection. Recently, published parameter sets and further parameter combinations were investigated. Heart rate data were obtained from the "Cardiac Arrhythmia Suppression Trial (CAST RR Interval Sub-Study Database" (Physionet. Corresponding outcomes and clinical data were provided by one of the investigators. The use of previously-reported parameter sets on the pre-treatment data did not significantly add to the identification of patients at risk for cardiovascular death on follow-up. After arrhythmia suppression treatment, several parameter sets predicted outcomes for all patients and patients without coronary artery bypass grafting (CABG. The strongest results were seen using the threshold parameter as a multiple of the data’s standard deviation ( r = 0 . 2 · σ . Approximate and sample entropy provided significant hazard ratios for patients without CABG and without diabetes for an entropy maximizing threshold approximation. Additional parameter combinations did not improve the results for pre-treatment data. The results of this study illustrate the influence of parameter selection on entropy measures’ potential for cardiovascular risk stratification and support the potential use of entropy measures in future studies.

  13. Influence of mild therapeutic hypothermia after cardiac arrest on hospital mortality

    NARCIS (Netherlands)

    van der Wal, Greetje; Brinkman, Sylvia; Bisschops, Laurens L. A.; Hoedemaekers, Cornelia W.; van der Hoeven, Johannes G.; de Lange, Dylan W.; de Keizer, Nicolette F.; Pickkers, Peter

    2011-01-01

    Objective: Following two randomized controlled trials that demonstrated reduced mortality and better neurological outcome in cardiac arrest patients, mild therapeutic hypothermia was implemented in many intensive care units. Up to now, no large observational studies have confirmed the beneficial

  14. A randomized controlled trial of stage-matched intervention for smoking cessation in cardiac out-patients.

    Science.gov (United States)

    Chan, Sophia S C; Leung, Doris Y P; Wong, David C N; Lau, Chu-Pak; Wong, Vivian T; Lam, Tai-Hing

    2012-04-01

    To examine the effectiveness of a stage-matched smoking cessation counselling intervention for smokers who had cardiac diseases. A total of 1860 Chinese cardiac patients who smoked at least one cigarette in the past 7 days and aged 18 years or above recruited from cardiac out-patient clinics in Hong Kong hospitals were allocated randomly to an intervention group or control group. The intervention group (n = 938) received counselling matched with their stage of readiness to quit by trained counsellors at baseline, 1 week and 1 month. The control group (n = 922) received brief counselling on healthy diet at baseline. The primary outcomes were self-reported 7-day and 30-day point prevalence (PP) of tobacco abstinence at 12 months after baseline. The secondary outcome measures included biochemically validated abstinence at 12-month follow-up, self-reported 7-day and 30-day PP abstinence and reduction of cigarette consumption by 50% at 3 and 6 months. By intention-to-treat analysis, the intervention and control groups showed no significant difference in self-reported 7-day PP abstinence (intervention: 26.5% versus control: 25.5%; P = 0.60) and 30-day PP (intervention: 25.4% versus control: 24.2%; P = 0.55), biochemically validated abstinence (intervention: 6.6% versus control: 4.9%; P = 0.14) and overall quit attempts of least 24 hours (intervention: 40.3% versus control: 34.3%; P = 0.007) at the 12-month follow-up, adjusted for the baseline stage of readiness to quit smoking. An intervention, based on the Stages of Change model, to promote smoking cessation in cardiac patients in China failed to find any long-term benefit. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  15. Usefulness of Serum B-Type Natriuretic Peptide Levels in Comatose Patients Resuscitated from Out-of-Hospital Cardiac Arrest to Predict Outcome

    DEFF Research Database (Denmark)

    Frydland, Martin; Kjaergaard, Jesper; Erlinge, David

    2016-01-01

    N-terminal pro-B-type natriuretic (NT-proBNP) is expressed in the heart and brain, and serum levels are elevated in acute heart and brain diseases. We aimed to assess the possible association between serum levels and neurological outcome and death in comatose patients resuscitated from out......-of-hospital cardiac arrest (OHCA). Of the 939 comatose OHCA patients enrolled and randomized in the Targeted Temperature Management (TTM) trial to TTM at 33°C or 36°C for 24 hours, 700 were included in the biomarker substudy. Of these, 647 (92%) had serum levels of NT-proBNP measured 24, 48, and 72 hours after return...... of spontaneous circulation (ROSC). Neurological outcome was evaluated by the Cerebral Performance Category (CPC) score and modified Rankin Scale (mRS) at 6 months. Six hundred thirty-eight patients (99%) had serum NT-proBNP levels ≥125 pg/ml. Patients with TTM at 33°C had significantly lower NT-proBNP serum...

  16. Two-year survival and neurodevelopmental outcomes after cardiopulmonary resuscitation in neonatal patients after complex cardiac surgery.

    Science.gov (United States)

    Hansen, Gregory; Joffe, Ari R; Nettel-Aguirre, Alberto; Robertson, Charlene M T; Biggs, Wayne S G; Ross, David B; Rebeyka, Ivan M

    2011-03-01

    To examine survival and neurodevelopmental outcomes in neonates having post-operative cardiopulmonary resuscitation (CPR). This inception cohort study included all neonates (6 weeks old or less) who received postoperative CPR (Group 1) after cardiac surgery from 1996 to 2005, matched for heart defect, year of surgery, chromosomal abnormality, and socioeconomic status to two neonates who did not receive postoperative CPR (Group 2). Two-year neurodevelopment was prospectively assessed with Bayley Scales of Infant Development II and Adaptive Behavior Assessment System II. Pre-, intra-, and post-operative variables were collected prospectively. Cardiac arrest variables were collected retrospectively. Predictors of mortality were analyzed by univariate analysis and conditional multiple logistic regression. There were 29 patients in Group 1, and 58 patients in Group 2. In survivors, there were no significant differences between Groups 1 and 2 in outcomes [mean (SD)] of mental developmental index [84.5 (12.2) vs. 81.0 (18.9)], psychomotor developmental index [82.8 (13.8) vs. 80.1 (21.9)], General Adaptive Composite [84.6 (15.3) vs. 84.3 (19.2)], Motor scale [8.4 (3.2) vs. 8.0 (3.8)], or delay on any of these scales. Two-year mortality [58.6% Group 1; 8.6% Group 2], was associated on conditional multiple logistic regression with CPR (OR 26.6; 95% CI, 5.4, 129.5). In Group 1, on multiple logistic regression, 2-year mortality was associated with minutes of chest compressions (OR 1.04, 95% CI, 1.01, 1.08). Among neonates having cardiac surgery, CPR is associated with greater mortality. There is no evidence that CPR survivors have different 2-year neurodevelopmental outcomes than those neonates not having CPR. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  17. The New York State cardiac registries: history, contributions, limitations, and lessons for future efforts to assess and publicly report healthcare outcomes.

    Science.gov (United States)

    Hannan, Edward L; Cozzens, Kimberly; King, Spencer B; Walford, Gary; Shah, Nirav R

    2012-06-19

    In 1988, the New York State Health Commissioner was confronted with hospital-level data demonstrating very large, multiple-year, interhospital variations in short-term mortality and complications for cardiac surgery. The concern with the extent to which these differences were due to variations in patients' pre-surgical severity of illness versus hospitals' quality of care led to the development of clinical registries for cardiac surgery in 1989 and for percutaneous coronary interventions in 1992 in New York. In 1990, the Department of Health released hospitals' risk-adjusted cardiac surgery mortality rates for the first time, and shortly thereafter, similar data were released for hospitals and physicians for percutaneous coronary interventions, cardiac valve surgery, and pediatric cardiac surgery (only hospital data). This practice is still ongoing. The purpose of this communication is to relate the history of this initiative, including changes or purported changes that have occurred since the public release of cardiac data. These changes include decreases in risk-adjusted mortality, cessation of cardiac surgery in New York by low-volume and high-mortality surgeons, out-of-state referral or avoidance of cardiac surgery/angioplasty for high-risk patients, alteration of contracting choices by insurance companies, and modifications in market share of cardiac hospitals. Evidence related to these impacts is reviewed and critiqued. This communication also includes a summary of numerous studies that used New York's cardiac registries to examine a variety of policy issues regarding the choice and use of cardiac procedures, the comparative effectiveness of competing treatment options, and the examination of the relationship among processes, structures, and outcomes of cardiac care. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  18. Urinary tract infection in children after cardiac surgery: Incidence, causes, risk factors and outcomes in a single-center study.

    Science.gov (United States)

    Kabbani, Mohamed S; Ismail, Sameh R; Fatima, Anis; Shafi, Rehana; Idris, Julinar A; Mehmood, Akhter; Singh, Reetam K; Elbarabry, Mahmoud; Hijazi, Omar; Hussein, Mohamed A

    2016-01-01

    Nosocomial urinary tract infection (UTI) increases hospitalization, cost and morbidity. In this cohort study, we aimed to determine the incidence, risk factors, etiology and outcomes of UTIs in post-operative cardiac children. To this end, we studied all post-operative patients admitted to the Pediatric Cardiac Intensive Care Unit (PCICU) in 2012, and we divided the patients into two groups: the UTI (UTI group) and the non-UTI (control group). We compared both groups for multiple peri-operative risk factors. We included 413 children in this study. Of these, 29 (7%) had UTIs after cardiac surgery (UTI group), and 384 (93%) were free from UTIs (control group). All UTI cases were catheter-associated UTIs (CAUTIs). A total of 1578 urinary catheter days were assessed in this study, with a CAUTI density rate of 18 per 1000 catheter days. Multivariate logistic regression analysis demonstrated the following risk factors for CAUTI development: duration of urinary catheter placement (purinary tract (CAKUT) (purinary catheter, the presence of CAKUT, and the presence of syndromes comprised the main risk factors for CAUTI. Gram-negative organisms were the main causes for CAUTI, and one-third of them found to be resistant in this single-center study. Copyright © 2016 King Saud Bin Abdulaziz University for Health Sciences. Published by Elsevier Ltd. All rights reserved.

  19. Extended cardiac rehabilitation for socially vulnerable patients improves attendance and outcome

    DEFF Research Database (Denmark)

    Nielsen, Kirsten Melgaard; Meillier, Lucette Kirsten; Larsen, Mogens Lytken

    2013-01-01

    Patients living alone or having a low socioeconomic status are likely to quit cardiac rehabilitation. We aimed to compare patients being offered extended rehabilitation (ERP) with those being offered standard rehabilitation (SRP) as concerns 1) attendance rates and 2) achievement of treatment goals...

  20. Process and Outcome in Cardiac Rehabilitation: An Examination of Cross-Lagged Effects.

    Science.gov (United States)

    Evon, Donna M.; Burns, John W.

    2004-01-01

    Cardiac rehabilitation patients improve cardiorespiratory fitness and quality of life, yet therapeutic processes that produce these changes remain unknown. A cross-lagged panel design was used to determine whether early-treatment enhancement of self-efficacy regarding abilities to change diet and exercise habits and the quality of the…

  1. Understanding cardiac extracellular matrix remodeling to develop biomarkers of myocardial infarction outcomes

    DEFF Research Database (Denmark)

    Nielsen, Signe Holm; Mouton, Alan J.; DeLeon-Pennell, Kristine Y.

    2017-01-01

    matrix (ECM) scar formation to replace necrotic myocytes. While ECM accumulation following MI is termed cardiac fibrosis, this is a generic term that does not differentiate between ECM accumulation that occurs in the infarct region to form a scar that is structurally necessary to preserve left ventricle...

  2. [Relationship between previous severity of illness and outcome of in-hospital cardiac arrest].

    Science.gov (United States)

    Serrano, M; Rodríguez, J; Espejo, A; del Olmo, R; Llanos, S; Del Castillo, J; López-Herce, J

    2014-07-01

    To analyze the relationship between previous severity of illness, lactic acid, creatinine and inotropic index with mortality of in-hospital cardiac arrest (CA) in children, and the value of a prognostic index designed for adults. The study included total of 44 children aged from 1 month to 18 years old who suffered a cardiac arrest while in hospital. The relationship between previous severity of illness scores (PRIMS and PELOD), lactic acid, creatinine, treatment with vasoactive drugs, inotropic index with return of spontaneous circulation and survival at hospital discharge was analyzed. The large majority (90.3%) of patients had a return of spontaneous circulation, and 59% survived at hospital discharge. More than two-thirds (68.2%) were treated with inotropic drugs at the time of the CA. The patients who died had a higher lactic acid before the CA (3.4 mmol/L) than survivors (1.4 mmol/L), P=.04. There were no significant differences in PRIMS, PELOD, creatinine, inotropic drugs, and inotropic index before CA between patients who died and survivors. A high lactic acid previous to cardiac arrest could be a prognostic factor of in-hospital cardiac arrest in children. Copyright © 2013 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

  3. Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial.

    Science.gov (United States)

    van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G

    2018-01-01

    had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.

  4. GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wiberg, Sebastian; Hassager, Christian; Thomsen, Jakob Hartvig; Frydland, Martin; Høfsten, Dan Eik; Engstrøm, Thomas; Køber, Lars; Schmidt, Henrik; Møller, Jacob Eifer; Kjaergaard, Jesper

    2016-06-30

    Attenuating the neurological damage occurring after out-of-hospital cardiac arrest is an ongoing research effort. This dual-centre study investigates the neuroprotective effects of the glucagon-like-peptide-1 analogue Exenatide administered within 4 hours from the return of spontaneous circulation to comatose patients resuscitated from out-of-hospital cardiac arrest. This pilot study will randomize a total of 120 unconscious patients with sustained return of spontaneous circulation after out-of-hospital cardiac arrest undergoing targeted temperature management in a blinded one-to-one fashion to a 6-hour and 15-minute infusion of either Exenatide or placebo. Patients are eligible for inclusion if resuscitated from cardiac arrest with randomization from 20 minutes to 240 minutes after return of spontaneous circulation. The co-primary endpoint is feasibility, defined as the initiation of treatment within the inclusion window in more than 90 % of participants, and efficacy, defined as the area under the neuron-specific enolase curve from 0 to 72 hours after admission. Secondary endpoints include all-cause mortality at 30 days and Cerebral Performance Category as well as a modified Rankin Score at 180 days. The study has been approved by the Danish National Board of Health and the local Ethics Committee and is monitored by Good Clinical Practice units. The study is currently enrolling. This paper presents the methods and planned statistical analyses used in the GLP-1 trial and aims to minimize bias and data-driven reporting of results. 1) Danish National Board of Health, EudraCT 2013-004311-45. Registered on 25 March 2014. 2) Videnskabsetisk komité C, Region Hovedstaden, No. 45728. Registered on 29 January 2014. 3) Clinicaltrial.gov, NCT02442791 . Registered on 25 of January 2015.

  5. A meta-analysis of mental health treatments and cardiac rehabilitation for improving clinical outcomes and depression among patients with coronary heart disease.

    Science.gov (United States)

    Rutledge, Thomas; Redwine, Laura S; Linke, Sarah E; Mills, Paul J

    2013-05-01

    To quantify the efficacy of mental health (antidepressants & psychotherapies) and cardiac rehabilitation treatments for improving secondary event risk and depression among patients with coronary heart disease (CHD). Using meta-analytic methods, we evaluated mental health and cardiac rehabilitation therapies for a) reducing secondary events and 2) improving depression severity in patients with CHD. Key word searches of PubMed and Psychlit databases and previous reviews identified relevant trials. Eighteen mental health trials evaluated secondary events and 22 trials evaluated depression reduction. Cardiac rehabilitation trials for the same categories numbered 17 and 13, respectively. Mental health treatments did not reduce total mortality (absolute risk reduction [ARR] = -0.001, confidence interval [95% CI] = -0.016 to 0.015; number needed to treat [NNT] = ∞), showed moderate efficacy for reducing CHD events (ARR = 0.029, 95% CI = 0.007 to 0.051; NNT = 34), and a medium effect size for improving depression (Cohen d = 0.297). Cardiac rehabilitation showed similar efficacy for treating depression (d = 0.23) and reducing CHD events (ARR = 0.017, 95% CI = 0.007 to 0.026; NNT = 59) and reduced total mortality (ARR = 0.016, 95% CI = 0.005 to 0.027; NNT = 63). Among patients with CHD, mental health treatments and cardiac rehabilitation may each reduce depression and CHD events, whereas cardiac rehabilitation is superior for reducing total mortality risk. The results support a continued role for mental health treatments and a larger role for mental health professionals in cardiac rehabilitation.

  6. The influence of body mass index on outcomes in patients undergoing cardiac surgery: does the obesity paradox really exist?

    Directory of Open Access Journals (Sweden)

    Juan Carlos Lopez-Delgado

    Full Text Available Obesity influences risk stratification in cardiac surgery in everyday practice. However, some studies have reported better outcomes in patients with a high body mass index (BMI: this is known as the obesity paradox. The aim of this study was to quantify the effect of diverse degrees of high BMI on clinical outcomes after cardiac surgery, and to assess the existence of an obesity paradox in our patients.A total of 2,499 consecutive patients requiring all types of cardiac surgery with cardiopulmonary bypass between January 2004 and February 2009 were prospectively studied at our institution. Patients were divided into four groups based on BMI: normal weight (18.5-24.9 kg∙m-2; n = 523; 21.4%, overweight (25-29.9 kg∙m-2; n = 1150; 47%, obese (≥ 30-≤ 34.9 kg∙m-2; n = 624; 25.5% and morbidly obese (≥ 35kg∙m-2; n = 152; 6.2%. Follow-up was performed in 2,379 patients during the first year.After adjusting for confounding factors, patients with higher BMI presented worse oxygenation and better nutritional status, reflected by lower PaO2/FiO2 at 24h and higher albumin levels 48 h after admission respectively. Obese patients showed a higher risk for Perioperative Myocardial Infarction (OR: 1.768; 95% CI: 1.035-3.022; p = 0.037 and septicaemia (OR: 1.489; 95% CI: 1.282-1.997; p = 0.005. In-hospital mortality was 4.8% (n = 118 and 1-year mortality was 10.1% (n = 252. No differences were found regarding in-hospital mortality between BMI groups. The overweight group showed better 1-year survival than normal weight patients (91.2% vs. 87.6%; Log Rank: p = 0.029. HR: 1.496; 95% CI: 1.062-2.108; p = 0.021.In our population, obesity increases Perioperative Myocardial Infarction and septicaemia after cardiac surgery, but does not influence in-hospital mortality. Although we found better 1-year survival in overweight patients, our results do not support any protective effect of obesity in patients undergoing cardiac surgery.

  7. Outcome of cardiac surgery in patients with congenital heart disease in England between 1997 and 2015.

    Directory of Open Access Journals (Sweden)

    Aleksander Kempny

    Full Text Available The number of patients with congenital heart disease (CHD is increasing worldwide and most of them will require cardiac surgery, once or more, during their lifetime. The total volume of cardiac surgery in CHD patients at a national level and the associated mortality and predictors of death associated with surgery are not known. We aimed to investigate the surgical volume and associated mortality in CHD patients in England.Using a national hospital episode statistics database, we identified all CHD patients undergoing cardiac surgery in England between 1997 and 2015.We evaluated 57,293 patients (median age 11.9years, 46.7% being adult, 56.7% female. There was a linear increase in the number of operations performed per year from 1,717 in 1997 to 5,299 performed in 2014. The most common intervention at the last surgical event was an aortic valve procedure (9,276; 16.2%, followed by repair of atrial septal defect (9,154; 16.0%, ventricular septal defect (7,746; 13.5%, tetralogy of Fallot (3,523; 6.1% and atrioventricular septal defect (3,330; 5.8% repair. Associated mortality remained raised up to six months following cardiac surgery. Several parameters were predictive of post-operative mortality, including age, complexity of surgery, need for emergency surgery and socioeconomic status. The relationship of age with mortality was "U"-shaped, and mortality was highest amongst youngest children and adults above 60 years of age.The number of cardiac operations performed in CHD patients in England has been increasing, particularly in adults. Mortality remains raised up to 6-months after surgery and was highest amongst young children and seniors.

  8. Associations between blood glucose level and outcomes of adult in-hospital cardiac arrest: a retrospective cohort study.

    Science.gov (United States)

    Wang, Chih-Hung; Huang, Chien-Hua; Chang, Wei-Tien; Tsai, Min-Shan; Yu, Ping-Hsun; Wu, Yen-Wen; Chen, Wen-Jone

    2016-08-24

    We intended to analyse the associations between blood glucose (BG) level and clinical outcomes of in-hospital cardiac arrest (IHCA). We conducted a retrospective observational study in a single medical centre and evaluated patients who experienced IHCA between 2006 and 2014. We used multivariable logistic regression analysis to study associations between independent variables and outcomes. We calculated the mean BG level for each patient by averaging the maximum and minimum BG levels in the first 24 h after arrest, and we used mean BG level for our final analysis. We included a total of 402 patients. Of these, 157 patients (39.1 %) had diabetes mellitus (DM). The average mean BG level was 209.9 mg/dL (11.7 mmol/L). For DM patients, a mean BG level between 183 and 307 mg/dL (10.2-17.1 mmol/L) was significantly associated with favourable neurological outcome (odds ratio [OR] 2.71, 95 % confidence interval [CI] 1.18-6.20; p value = 0.02); a mean BG level between 147 and 317 mg/dL (8.2-17.6 mmol/L) was significantly associated with survival to hospital discharge (OR 2.38, 95 % CI 1.26-4.53; p value = 0.008). For non-DM patients, a mean BG level between 143 and 268 mg/dL (7.9-14.9 mmol/L) was significantly associated with survival to hospital discharge (OR 2.93, 95 % CI 1.62-5.40; p value level in the first 24 h after cardiac arrest was associated with neurological outcome for IHCA patients with DM. For neurological and survival outcomes, the optimal BG range may be higher for patients with DM than for patients without DM.

  9. The effect of COPD severity and study duration on exacerbation outcome in randomized controlled trials

    NARCIS (Netherlands)

    Eriksson, Goran; Calverley, Peter M.; Jenkins, Christine R.; Anzueto, Antonio R.; Make, Barry J.; Lindberg, Magnus; Fageras, Malin; Postma, Dirkje S.

    2017-01-01

    Background: When discontinuation in COPD randomized controlled trials (RCTs) is unevenly distributed between treatments (differential dropout), the capacity to demonstrate treatment effects may be reduced. We investigated the impact of the time of differential dropout on exacerbation outcomes in

  10. Prognostic value of depression, anxiety, and anger in hospitalized cardiovascular disease patients for predicting adverse cardiac outcomes.

    Science.gov (United States)

    Nakamura, Shunichi; Kato, Koji; Yoshida, Asuka; Fukuma, Nagaharu; Okumura, Yasuyuki; Ito, Hiroto; Mizuno, Kyoichi

    2013-05-15

    Although attention has recently been focused on the role of psychosocial factors in patients with cardiovascular disease (CVD), the factors that have the greatest influence on prognosis have not yet been elucidated. The aim of this study was to evaluate the effects of depression, anxiety, and anger on the prognosis of patients with CVD. Four hundred fourteen consecutive patients hospitalized with CVD were prospectively enrolled. Depression was evaluated using the Patient Health Questionnaire, anxiety using the Generalized Anxiety Disorder Questionnaire, and anger using the Spielberger Trait Anger Scale. Cox proportional-hazards regression was used to examine the individual effects of depression, anxiety, and anger on a combined primary end point of cardiac death or cardiac hospitalization and on a combined secondary end point of all-cause death or hospitalization during follow-up (median 14.2 months). Multivariate analysis showed that depression was a significant risk factor for cardiovascular hospitalization or death after adjusting for cardiac risk factors and other psychosocial factors (hazard ratio 2.62, p = 0.02), whereas anxiety was not significantly associated with cardiovascular hospitalization or death after adjustment (hazard ratio 2.35, p = 0.10). Anger was associated with a low rate of cardiovascular hospitalization or death (hazard ratio 0.34, p depression in hospitalized patients with CVD is a stronger independent risk factor for adverse cardiac events than either anxiety or anger. Anger may help prevent adverse outcomes. Routine screening for depression should therefore be performed in patients with CVD, and the potential effects of anger in clinical practice should be reconsidered. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Urinary tract infection in children after cardiac surgery: Incidence, causes, risk factors and outcomes in a single-center study

    Directory of Open Access Journals (Sweden)

    Mohamed S. Kabbani

    2016-09-01

    Full Text Available Summary: Nosocomial urinary tract infection (UTI increases hospitalization, cost and morbidity. In this cohort study, we aimed to determine the incidence, risk factors, etiology and outcomes of UTIs in post-operative cardiac children. To this end, we studied all post-operative patients admitted to the Pediatric Cardiac Intensive Care Unit (PCICU in 2012, and we divided the patients into two groups: the UTI (UTI group and the non-UTI (control group. We compared both groups for multiple peri-operative risk factors. We included 413 children in this study. Of these, 29 (7% had UTIs after cardiac surgery (UTI group, and 384 (93% were free from UTIs (control group. All UTI cases were catheter-associated UTIs (CAUTIs. A total of 1578 urinary catheter days were assessed in this study, with a CAUTI density rate of 18 per 1000 catheter days. Multivariate logistic regression analysis demonstrated the following risk factors for CAUTI development: duration of urinary catheter placement (p < 0.001, presence of congenital abnormalities of kidney and urinary tract (CAKUT (p < 0.0041 and the presence of certain syndromes (Down, William, and Noonan (p < 0.02. Gram-negative bacteria accounted for 63% of the CAUTI. The main causes of CAUTI were Klebsiella (27%, Candida (24% and Escherichia coli (21%. Resistant organisms caused 34% of CAUTI. Two patients (7% died in the UTI group compared with the one patient (0.3% who died in the control group (p < 0.05. Based on these findings, we concluded that an increased duration of the urinary catheter, the presence of CAKUT, and the presence of syndromes comprised the main risk factors for CAUTI. Gram-negative organisms were the main causes for CAUTI, and one-third of them found to be resistant in this single-center study. Keywords: Urinary tract infection, Cardiac surgery, Nosocomial

  12. Comparison of Outcomes in Patients With Versus Without Diabetes Mellitus After Revascularization With Everolimus- and Sirolimus-Eluting Stents (from the SORT OUT IV Trial)

    DEFF Research Database (Denmark)

    Jensen, Lisette Okkels; Thayssen, Per; Junker, Anders

    2012-01-01

    Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents...... (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point...... was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients...

  13. Integration of technology-based outcome measures in clinical trials of Parkinson and other neurodegenerative diseases.

    Science.gov (United States)

    Artusi, Carlo Alberto; Mishra, Murli; Latimer, Patricia; Vizcarra, Joaquin A; Lopiano, Leonardo; Maetzler, Walter; Merola, Aristide; Espay, Alberto J

    2018-01-01

    We sought to review the landscape of past, present, and future use of technology-based outcome measures (TOMs) in clinical trials of neurodegenerative disorders. We systematically reviewed PubMed and ClinicalTrials.gov for published and ongoing clinical trials in neurodegenerative disorders employing TOMs. In addition, medical directors of selected pharmaceutical companies were surveyed on their companies' ongoing efforts and future plans to integrate TOMs in clinical trials as primary, secondary, or exploratory endpoints. We identified 164 published clinical trials indexed in PubMed that used TOMs as outcome measures in Parkinson disease (n = 132) or other neurodegenerative disorders (n = 32). The ClinicalTrials.gov search yielded 42 clinical trials using TOMs, representing 2.7% of ongoing trials. Sensor-based technology accounted for over 75% of TOMs applied. Gait and physical activity were the most common targeted domains. Within the next 5 years, 83% of surveyed pharmaceutical companies engaged in neurodegenerative disorders plan to deploy TOMs in clinical trials. Although promising, TOMs are underutilized in clinical trials of neurodegenerative disorders. Validating relevant endpoints, standardizing measures and procedures, establishing a single platform for integration of data and algorithms from different devices, and facilitating regulatory approvals should advance TOMs integration into clinical trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Wetterslev, Jørn; al-Subaie, Nawaf

    2012-01-01

    Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32°C to 34°C for 12 to 24 hours after resuscitation...... from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia...... in the control groups. The optimal target temperature management strategy is not known....

  15. Daily FOUR score assessment provides accurate prognosis of long-term outcome in out-of-hospital cardiac arrest.

    Science.gov (United States)

    Weiss, N; Venot, M; Verdonk, F; Chardon, A; Le Guennec, L; Llerena, M C; Raimbourg, Q; Taldir, G; Luque, Y; Fagon, J-Y; Guerot, E; Diehl, J-L

    2015-05-01

    The accurate prediction of outcome after out-of-hospital cardiac arrest (OHCA) is of major importance. The recently described Full Outline of UnResponsiveness (FOUR) is well adapted to mechanically ventilated patients and does not depend on verbal response. To evaluate the ability of FOUR assessed by intensivists to accurately predict outcome in OHCA. We prospectively identified patients admitted for OHCA with a Glasgow Coma Scale below 8. Neurological assessment was performed daily. Outcome was evaluated at 6 months using Glasgow-Pittsburgh Cerebral Performance Categories (GP-CPC). Eighty-five patients were included. At 6 months, 19 patients (22%) had a favorable outcome, GP-CPC 1-2, and 66 (78%) had an unfavorable outcome, GP-CPC 3-5. Compared to both brainstem responses at day 3 and evolution of Glasgow Coma Scale, evolution of FOUR score over the three first days was able to predict unfavorable outcome more precisely. Thus, absence of improvement or worsening from day 1 to day 3 of FOUR had 0.88 (0.79-0.97) specificity, 0.71 (0.66-0.76) sensitivity, 0.94 (0.84-1.00) PPV and 0.54 (0.49-0.59) NPV to predict unfavorable outcome. Similarly, the brainstem response of FOUR score at 0 evaluated at day 3 had 0.94 (0.89-0.99) specificity, 0.60 (0.50-0.70) sensitivity, 0.96 (0.92-1.00) PPV and 0.47 (0.37-0.57) NPV to predict unfavorable outcome. The absence of improvement or worsening from day 1 to day 3 of FOUR evaluated by intensivists provides an accurate prognosis of poor neurological outcome in OHCA. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  16. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

    NARCIS (Netherlands)

    Mohr, J.P.; Overbey, J.R.; Kummer, R. von; Stefani, M.A.; Libman, R.; Stapf, C.; Parides, M.K.; Pile-Spellman, J.; Moquete, E.; Moy, C.S.; Vicaut, E.; Moskowitz, A.J.; Harkness, K.; Cordonnier, C.; Biondi, A.; Houdart, E.; Berkefeld, J.; Klijn, C.J.M.; Barreau, X.; Kim, H.; Hartmann, A.

    2017-01-01

    OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults >/=18

  17. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs

    NARCIS (Netherlands)

    Mohr, J P; Overbey, Jessica R; von Kummer, Ruediger; Stefani, Marco A; Libman, Richard; Stapf, Christian; Parides, Michael K; Pile-Spellman, John; Moquete, Ellen; Moy, Claudia S; Vicaut, Eric; Moskowitz, Alan J; Harkness, Kirsty; Cordonnier, Charlotte; Biondi, Alessandra; Houdart, Emmanuel; Berkefeld, Joachim; Klijn, Karin J M; Barreau, Xavier; Kim, Helen; Hartmann, Andreas; van Dijk, J. Marc C.; Luijckx, Gert Jan

    2017-01-01

    OBJECTIVE: To investigate the effects of medical vs interventional management on functional outcome in A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA). METHODS: We used the initial results of a nonblinded, randomized, controlled, parallel-group trial involving adults ≥18

  18. Renal Insufficiency and Early Bystander CPR Predict In-Hospital Outcomes in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia and Cardiac Catheterization: Return of Spontaneous Circulation, Cooling, and Catheterization Registry (ROSCCC Registry

    Directory of Open Access Journals (Sweden)

    Anjala Chelvanathan

    2016-01-01

    Full Text Available Objective. Out of hospital cardiac arrest (OHCA patients are a critically ill patient population with high mortality. Combining mild therapeutic hypothermia (MTH with early coronary intervention may improve outcomes in this population. The aim of this study was to evaluate predictors of mortality in OHCA patients undergoing MTH with and without cardiac catheterization. Design. A retrospective cohort of OHCA patients who underwent MTH with catheterization (MTH + C and without catheterization (MTH + NC between 2006 and 2011 was analyzed at a single tertiary care centre. Predictors of in-hospital mortality and neurologic outcome were determined. Results. The study population included 176 patients who underwent MTH for OHCA. A total of 66 patients underwent cardiac catheterization (MTH + C and 110 patients did not undergo cardiac catheterization (MTH + NC. Immediate bystander CPR occurred in approximately half of the total population. In the MTH + C and MTH + NC groups, the in-hospital mortality was 48% and 78%, respectively. The only independent predictor of in-hospital mortality for patients with MTH + C, after multivariate analysis, was baseline renal insufficiency (OR = 8.2, 95% CI 1.8–47.1, and p = 0.009. Conclusion. Despite early cardiac catheterization, renal insufficiency and the absence of immediate CPR are potent predictors of death and poor neurologic outcome in patients with OHCA.

  19. A randomized trial evaluating different modalities of levosimendan administration in cardiac surgery patients with myocardial dysfunction

    NARCIS (Netherlands)

    de Hert, Stefan G.; Lorsomradee, Suraphong; vanden Eede, Hervé; Cromheecke, Stefanie; van der Linden, Philippe J.

    2008-01-01

    OBJECTIVE: To evaluate the effects of 2 different administration modalities of levosimendan (start before cardiopulmonary bypass [CPB] and at the end of CPB) compared with a standard treatment with milrinone started at the end of CPB in cardiac surgery patients with a preoperative ejection fraction

  20. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial

    NARCIS (Netherlands)

    Knops, Reinoud E.; Tjong, Fleur V. Y.; Neuzil, Petr; Sperzel, Johannes; Miller, Marc A.; Petru, Jan; Simon, Jaroslav; Sediva, Lucie; de Groot, Joris R.; Dukkipati, Srinivas R.; Koruth, Jacob S.; Wilde, Arthur A. M.; Kautzner, Josef; Reddy, Vivek Y.

    2015-01-01

    A leadless cardiac pacemaker (LCP) system was recently introduced to overcome lead-related complications of conventional pacing systems. To date, long-term results of an LCP system are unknown. The aim of this study was to assess the complication incidence, electrical performance, and rate response

  1. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial

    DEFF Research Database (Denmark)

    Rafiq, Sulman; Steinbrüchel, Daniel Andreas; Wanscher, Michael Jaeger

    2014-01-01

    BACKGROUND: To evaluate if an opiate sparing multimodal regimen of dexamethasone, gabapentin, ibuprofen and paracetamol had better analgesic effect, less side effects and was safe compared to a traditional morphine and paracetamol regimen after cardiac surgery. METHODS: Open-label, prospective...

  2. Ibuprofen - a Safe Analgesic During Cardiac Surgery Recovery? A Randomized Controlled Trial?

    Directory of Open Access Journals (Sweden)

    Saddiq Mohammad Qazi

    2015-12-01

    Conclusion: The results of this study suggest that patients treated postoperatively, following cardiac surgery, are at no greater risk of harm if short term slow release ibuprofen combined with lansoprazole treatment is used when compared to an oxycodone based regimen. Renal function should, however, be closely monitored and in the event of any decrease in renal function ibuprofen must be discontinued.

  3. Outcomes Following Three-Factor Inactive Prothrombin Complex Concentrate Versus Recombinant Activated Factor VII Administration During Cardiac Surgery.

    Science.gov (United States)

    Harper, Patrick C; Smith, Mark M; Brinkman, Nathan J; Passe, Melissa A; Schroeder, Darrell R; Said, Sameh M; Nuttall, Gregory A; Oliver, William C; Barbara, David W

    2018-02-01

    To compare outcomes following inactive prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) administration during cardiac surgery. Retrospective propensity-matched analysis. Academic tertiary-care center. Patients undergoing cardiac surgery requiring cardiopulmonary bypass who received either rFVIIa or the inactive 3-factor PCC. Outcomes following intraoperative administration of rFVIIa (263) or factor IX complex (72) as rescue therapy to treat bleeding. In the 24 hours after surgery, propensity-matched patients receiving PCC versus rFVIIa had significantly less chest tube outputs (median difference -464 mL, 95% confidence interval [CI] -819 mL to -110 mL), fresh frozen plasma transfusion rates (17% v 38%, p = 0.028), and platelet transfusion rates (26% v 49%, p = 0.027). There were no significant differences between propensity-matched groups in postoperative stroke, deep venous thrombosis, pulmonary embolism, myocardial infarction, or intracardiac thrombus. Postoperative dialysis was significantly less likely in patients administered PCC versus rFVIIa following propensity matching (odds ratio = 0.3, 95% CI 0.1-0.7). No significant difference in 30-day mortality in patients receiving PCC versus rFVIIa was present following propensity matching. Use of rFVIIa versus inactive PCCs was significantly associated with renal failure requiring dialysis and increased postoperative bleeding and transfusions. Copyright © 2018 Elsevier Inc. All rights reserved.

  4. Randomized controlled trial of relaxation music to reduce heart rate in patients undergoing cardiac CT.

    Science.gov (United States)

    Ng, Ming Yen; Karimzad, Yasser; Menezes, Ravi J; Wintersperger, Bernd J; Li, Qin; Forero, Julian; Paul, Narinder S; Nguyen, Elsie T

    2016-10-01

    To evaluate the heart rate lowering effect of relaxation music in patients undergoing coronary CT angiography (CCTA), pulmonary vein CT (PVCT) and coronary calcium score CT (CCS). Patients were randomised to a control group (i.e. standard of care protocol) or to a relaxation music group (ie. standard of care protocol with music). The groups were compared for heart rate, radiation dose, image quality and dose of IV metoprolol. Both groups completed State-Trait Anxiety Inventory anxiety questionnaires to assess patient experience. One hundred and ninety-seven patients were recruited (61.9 % males); mean age 56y (19-86 y); 127 CCTA, 17 PVCT, 53 CCS. No significant difference in heart rate, radiation dose, image quality, metoprolol dose and anxiety scores. 86 % of patients enjoyed the music. 90 % of patients in the music group expressed a strong preference to have music for future examinations. The patient cohort demonstrated low anxiety levels prior to CT. Relaxation music in CCTA, PVCT and CCS does not reduce heart rate or IV metoprolol use. Patients showed low levels of anxiety indicating that anxiolytics may not have a significant role in lowering heart rate. Music can be used in cardiac CT to improve patient experience. • Relaxation music does not reduce heart rate in cardiac CT • Relaxation music does not reduce beta-blocker use in cardiac CT • Relaxation music has no effect on cardiac CT image quality • Low levels of anxiety are present in patients prior to cardiac CT • Patients enjoyed the relaxation music and this results in improved patient experience.

  5. Prenatally Diagnosis and Outcome of Fetuses with Cardiac Rhabdomyoma ? Single Centre Experience

    OpenAIRE

    Bejiqi, Ramush; Retkoceri, Ragip; Bejiqi, Hana

    2017-01-01

    BACKGROUND: Cardiac rhabdomyoma (CRs) are the most common primary tumour of the heart in infants and children. Usually are multiple and, basing on the location can cause a haemodynamic disturbance, dysrhythmias or heart failure during the fetal and early postnatal period. CRs have a natural history of spontaneous regression and are closely associated with tuberous sclerosis complex (TSC). It has an association with tuberous sclerosis (TS), and in those, the tumour may regress and disappear co...

  6. 59. Urinary tract infection in children after cardiac surgery: Incidence, risk factors and outcome

    Directory of Open Access Journals (Sweden)

    Rehana Shafi

    2015-10-01

    Conclusions: Foley catheter duration, presence of syndrome and prolonged PCICU and hospital stay were the main risk factors for CAUTI in postoperative pediatric cardiac patients. Resistant Gram-negative were the main cause for BSI with one third of CAUTI cases caused by MDRO or ESBL organisms. The cases with CAUTI were generally sicker and with more morbidity. The study will establish a baseline clinical indicator for monitoring quality improvement and the future measures to minimize CAUTI incidence, and its co-morbidity.

  7. Association of cardiac troponin I with disease severity and outcomes in patients with pulmonary hypertension.

    Science.gov (United States)

    Vélez-Martínez, Mariella; Ayers, Colby; Mishkin, Joseph D; Bartolome, Sonja B; García, Christine K; Torres, Fernando; Drazner, Mark H; de Lemos, James A; Turer, Aslan T; Chin, Kelly M

    2013-06-15

    Previous studies have identified cardiac troponin I (cTnI) as an important marker in pulmonary hypertension (PH) prognosis. However, traditional assays are limited by poor sensitivity, even among patients at high risk. cTnI was measured in 255 PH patients using a new highly sensitive (hs) assay. Other measures included demographics, creatinine, 6-minute walk distance, hemodynamics, cardiac magnetic resonance imaging, and B-type natriuretic peptide level. The association between cTnI and survival was assessed using Kaplan-Meier analysis and Cox regression. cTnI was detectable with the hs assay in 95% of the patients with a median level of 6.9 pg/ml (IQR 2.7-12.6 pg/ml). Higher cTnI levels associated with higher levels of B-type natriuretic peptide, shorter 6-minute walk distance, and more severe hemodynamic and cardiac magnetic resonance imaging abnormalities. During a median follow-up of 3.5 years, 60 individuals died. Unadjusted event rates increased across higher cTnI quartiles (3, 5, 13, 17 events/100 person-years, respectively, p trend = 0.002). cTnI in the fourth (vs first) quartile remained associated with death in a final stepwise multivariable model that included clinical variables and hemodynamics (adjusted hazard ratio 5.3, 95% confidence interval 1.8-15.6). In conclusion, cTnI levels, detectable with a novel hs assay, identify patients with PH who have more severe hemodynamic and cardiac structural abnormalities and provide novel and independent prognostic information. This hs assay has the potential to detect more at-risk patients and improve current risk-stratification algorithms. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. Motor outcome measures in Huntington disease clinical trials.

    Science.gov (United States)

    Reilmann, Ralf; Schubert, Robin

    2017-01-01

    Deficits in motor function are a hallmark of Huntington disease (HD). The Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS) is a categoric clinical rating scale assessing multiple domains of motor disability in HD. The UHDRS-TMS or subsets of its items have served as primary or secondary endpoints in numerous clinical trials. In spite of a well-established video-based annual online certification system, intra- and interrater variability, subjective error, and rater-induced placebo effects remain a concern. In addition, the UHDRS-TMS was designed to primarily assess motor symptoms in manifest HD. Recently, advancement of technology resulted in the introduction of the objective Q-Motor (i.e., Quantitative-Motor) assessments in biomarker studies and clinical trials in HD. Q-Motor measures detected motor signs in blinded cross-sectional and longitudinal analyses of manifest, prodromal, and premanifest HD cohorts up to two decades before clinical diagnosis. In a multicenter clinical trial in HD, Q-Motor measures were more sensitive than the UHDRS-TMS and exhibited no placebo effects. Thus, Q-Motor measures are currently explored in several multicenter trials targeting both symptomatic and disease-modifying mechanisms. They may supplement the UHDRS-TMS, increase the sensitivity and reliability in proof-of-concept studies, and open the door for phenotype assessments in clinical trials in prodromal and premanifest HD. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Early Lance-Adams syndrome after cardiac arrest: Prevalence, time to return to awareness, and outcome in a large cohort.

    Science.gov (United States)

    Aicua Rapun, Irene; Novy, Jan; Solari, Daria; Oddo, Mauro; Rossetti, Andrea O

    2017-06-01

    Early myoclonus after cardiac arrest (CA) is traditionally viewed as a poor prognostic sign (status myoclonus). However, some patients may present early Lance-Adams syndrome (LAS): under appropriate treatment, they can reach a satisfactory functional outcome. Our aim was to describe their profile, focusing on pharmacologic management in the ICU, time to return of awareness, and long-term prognosis. Adults with early LAS (defined as generalized myoclonus within 96h, with epileptiform EEG within 48h after CA) were retrospectively identified in our CA registry between 2006 and 2016. Functional outcome was assessed through cerebral performance categories (CPC) at 3 months, CPC 1-2 defined good outcome. Among 458 consecutive patients, 7 (1.5%) developed early LAS (4 women, median age 59 years). Within 72h after CA, in normothemia and off sedation, all showed preserved brainstem reflexes and localized pain. All patients were initially treated with valproate, levetiracetam and clonazepam; additional agents, including propofol and midazolam, were prescribed in the majority. First signs of awareness occurred after 3-23 days (median 11.8); 3/7 reached a good outcome at 3 months. Early after CA, myoclonus together with a reactive, epileptiform EEG, preserved evoked potentials and brainstem reflexes suggests LAS. This condition was managed with a combination of highly dosed, large spectrum antiepileptic agents including propofol and midazolam. Even if awakening was at times delayed, good outcome occurred in a substantial proportion of patients. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. SCANDCLEFT RANDOMIZED TRIALS: SPEECH OUTCOMES IN 5-YEAR-OLDS WITH UCLP - velopharyngeal competency and hypernasality

    DEFF Research Database (Denmark)

    Lohmander, Anette; Persson, Christina; Willadsen, Elisabeth

    2017-01-01

    Background and aim: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP...... (136 girls, 255 boys) were available and perceptually analysed. The main outcome measures were VPC and hypernasality from blinded assessments. Results: There were no statistically significant differences between the prevalences in the arms in any of the trials. VPC: Trial 1, A: 58%, B: 61%; Trial 2, A......: 57%, C: 54%; Trial 3, A: 35%, D: 51%. No hypernasality: Trial 1, A: 54%, B: 44%; Trial 2, A: 47%, C: 51%; Trial 3, A: 34%, D: 49%. Conclusions: No differences were found regarding VPC and hypernasality at age 5 years after different methods for primary palatal repair. The burden of care in terms...

  11. Maternal and neonatal outcomes in pregnant patients with cardiac diseases referred for labour in northwest Iran

    International Nuclear Information System (INIS)

    Yaghoubi, A.; Mirinazhad, M.

    2013-01-01

    Objective: To evaluate maternal and neonatal mortality and morbidity rates in women with different types of significant heart diseases. Methods: The cross-sectional study was conducted at a tertiary heart care centre in Tabriz, Iran, and comprised 200 pregnant women between March 2007 and March 2012 who had different cardiac diseases and were admitted in labour wards first and then transferred to the heart center for child-bearing (vaginal delivery or caesarean section). They were categorised based on the underlying etiology into valvular heart disease, dilated cardiomyopathy, congenital heart disease and other etiologies. SPSS 18 was used for statistical analysis. Results: The mean age of the 200 subjects was 29.4+-4.28 years. Caesarean section was performed on 152 (76%) cases, while 48 (24%) underwent vaginal delivery. There were 216 neonates as 16 (8%) women had twins. Overall, 164 (75.9%) were female, and 52 (24.1%) male. Maternal and neonatal mortality rates were 4.0% (n=8) and 10% (n=22) respectively. Pregnant women with Congenital heart disease experienced more maternal (p<0.022) and neonatal (p<0.031) mortality rates than other cardiac diseases. Conclusion: Pregnant women with cardiac diseases are prone to higher maternal and neonatal mortality rates in northwest Iran. (author)

  12. Randomised controlled trial examining the effect of an outpatient exercise training programme on haemodynamics and cardiac MR parameters of right ventricular function in patients with pulmonary arterial hypertension: the ExPAH study protocol.

    Science.gov (United States)

    Chia, Karen S W; Faux, Steven G; Wong, Peter K K; Holloway, Cameron; Assareh, Hassan; McLachlan, Craig S; Kotlyar, Eugene

    2017-02-06

    Pulmonary hypertension (PH) is a potentially life-threatening condition characterised by elevated pulmonary artery pressure. Early stage PH patients are often asymptomatic. Disease progression is associated with impairment of right ventricular function and progressive dyspnoea. Current guidelines recommend exercise training (grade IIa, level B). However, many questions remain regarding the mechanisms of improvement, intensity of supervision and optimal frequency, duration and intensity of exercise. This study will assess the effect of an outpatient rehabilitation programme on haemodynamics and cardiac right ventricular function in patients with pulmonary arterial hypertension (PAH), a subgroup of PH. This randomised controlled trial involves both a major urban tertiary and smaller regional hospital in New South Wales, Australia. The intervention will compare an outpatient rehabilitation programme with a control group (home exercise programme). Participants will be stable on oral PAH-specific therapy. The primary outcome measure will be right ventricular ejection fraction measured by cardiac MRI. Secondary outcomes will include haemodynamics measured by right heart catheterisation, endurance, functional capacity, health-related quality of life questionnaires and biomarkers of cardiac function and inflammation. Ethical approval has been granted by St Vincent's Hospital, Sydney (HREC/14/SVH/341). Results of this study will be disseminated through presentation at scientific conferences and in scientific journals. ACTRN12615001041549; pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. Effect of perioperative sodium bicarbonate administration on renal function following cardiac surgery for infective endocarditis: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Cho, Jin Sun; Soh, Sarah; Shim, Jae-Kwang; Kang, Sanghwa; Choi, Haegi; Kwak, Young-Lan

    2017-01-05

    Patients with infective endocarditis (IE) have an elevated risk of renal dysfunction because of extensive systemic inflammation and use of nephrotoxic antibiotics. In this randomized, placebo-controlled trial, we investigated whether perioperative sodium bicarbonate administration could attenuate postoperative renal dysfunction in patients with IE undergoing cardiac surgery. Seventy patients randomly received sodium chloride (n = 35) or sodium bicarbonate (n = 35). Sodium bicarbonate was administered as a 0.5 mmol/kg loading dose for 1 h commencing with anesthetic induction, followed by a 0.15 mmol/kg/h infusion for 23 h. The primary outcome was peak serum creatinine (SCr) level during the first 48 h postoperatively. The incidence of acute kidney injury, SCr level, estimated glomerular filtration rate, and major morbidity endpoints were assessed postoperatively. The peak SCr during the first 48 h postoperatively (bicarbonate vs. 1.01 (0.74, 1.37) mg/dl vs. 0.88 (0.76, 1.27) mg/dl, P = 0.474) and the incidence of acute kidney injury (bicarbonate vs. 29% vs. 23%, P = 0.584) were similar in both groups. The postoperative increase in SCr above baseline was greater in the bicarbonate group than in the control group on postoperative day 2 (0.21 (0.07, 0.33) mg/dl vs. 0.06 (0.00, 0.23) mg/dl, P = 0.028) and postoperative day 5 (0.23 (0.08, 0.36) mg/dl vs. 0.06 (0.00, 0.23) mg/dl, P = 0.017). Perioperative sodium bicarbonate administration had no favorable impact on postoperative renal function and outcomes in patients with IE undergoing cardiac surgery. Instead, it was associated with possibly harmful renal effects, illustrated by a greater increase in SCr postoperatively, compared to control. ClinicalTrials.gov, NCT01920126 . Registered on 31 July 2013.

  14. Association between patient unconscious or not alert conditions and cardiac arrest or high-acuity outcomes within the Medical Priority Dispatch System "Falls" protocol.

    Science.gov (United States)

    Clawson, Jeff; Olola, Christopher; Scott, Greg; Schultz, Bryon; Pertgen, Richard; Robinson, Don; Bagwell, Barry; Patterson, Brett

    2010-01-01

    Falls are one of the most common types of complaints received by 9-1-1 emergency medical dispatch centers. They can be accidental or may be caused by underlying medical problems. Though "not alert" falls patients with severe outcomes mostly are "hot" transported to the hospital, some of these cases may be due to other acute medical events (cardiac, respiratory, circulatory, or neurological), which may not always be apparent to the emergency medical dispatcher (EMD) during call processing. The objective of this study was to characterize the risk of cardiac arrest and "hot-transport" outcomes in patients with "not alert" condition, within the Medical Priority Dispatch System (MPDS®) Falls protocol descriptors. This retrospective study used 129 months of de-identified, aggregate, dispatch datasets from three US emergency communication centers. The communication centers used the Medical Priority Dispatch System version 11.3-OMEGA type (released in 2006) to interrogate Emergency Medical System callers, select dispatch codes assigned to various response configurations, and provide pre-arrival instructions. The distribution of cases and percentages of cardiac arrest and hot-transport outcomes, categorized by MPDS® code, was profiled. Assessment of the association between MPDS® Delta-level 3 (D-3) "not alert" condition and cardiac arrest and hot-transport outcomes then followed. Overall, patients within the D-3 and D-2 "long fall" conditions had the highest proportions (compared to the other determinants in the "falls" protocol) of cardiac arrest and hot-transport outcomes, respectively. "Not alert" condition was associated significantly with cardiac arrest and hot-transport outcomes (pdeterminant within the MPDS® "fall" protocol was associated significantly with severe outcomes for short falls (falls. As reported to 9-1-1, the complaint of a "fall" may include the presence of underlying conditions that go beyond the obvious traumatic injuries caused by the fall itself.

  15. [Cardiac arrest in spectators in German football stadiums. Precautionary measures, frequency and short-term outcome].

    Science.gov (United States)

    Luiz, T; Preisegger, T; Rombach, D; Madler, C

    2014-09-01

    Provision of medical care is an important element of safety precautions for visitors of sports arenas. The organizational requirements are especially high if cardiac arrest occurs; how this scenario is managed may thus serve as the ultimate indicator of the quality of stadium medical care. The objectives of this study were to analyze the structures and the resources available for the medical care of spectators in German professional soccer stadiums and to identify the frequency and the primary resuscitation success of cardiac arrest. In 2011 a questionnaire-based survey was performed among the clubs of the first and second German soccer leagues regarding medical care of spectators during the seasons 2008/2009 and 2009/2010. The focus was on the qualifications of emergency teams, the equipment and the incidence of cardiac arrest. A total of 15 stadiums were included (38%) in the survey. The mean number of physicians and emergency medical technicians on site was 0.6/10,000 seats and 16/10,000 seats, respectively. Of the latter, a mean of 82% (minimum 20% and maximum 100%) had received training with automatic external defibrillators. In 87% of the stadiums regular advanced life support training (ALS) was required. The mean number of defibrillators per stadium was 2.8/10,000 seats (minimum 1.3 and maximum 3.8) including 1.7 automatic defibrillators (minimum 0.4 and maximum 2.8). For patient transport, a mean of 0.65 ALS ambulance vehicles per 10,000 seats (minimum 0.14 and maximum 1.46) were available on site. In all stadiums staff members were connected via mobile radio communication with the stadium medical control room. A total of 52 cardiac arrests (=0.25/100,000 spectators) were recorded of which 96% of the patients were transported to hospitals with spontaneous circulation. Cardiac arrests are not a rare occurrence in German soccer stadiums. The participating stadiums are overall well prepared for such incidents in terms of organization, staff and technology and

  16. Sensitivity of adaptive enrichment trial designs to accrual rates, time to outcome measurement, and prognostic variables

    Directory of Open Access Journals (Sweden)

    Tianchen Qian

    2017-12-01

    Full Text Available Adaptive enrichment designs involve rules for restricting enrollment to a subset of the population during the course of an ongoing trial. This can be used to target those who benefit from the experimental treatment. Trial characteristics such as the accrual rate and the prognostic value of baseline variables are typically unknown when a trial is being planned; these values are typically assumed based on information available before the trial starts. Because of the added complexity in adaptive enrichment designs compared to standard designs, it may be of special concern how sensitive the trial performance is to deviations from assumptions. Through simulation studies, we evaluate the sensitivity of Type I error, power, expected sample size, and trial duration to different design characteristics. Our simulation distributions mimic features of data from the Alzheimer's Disease Neuroimaging Initiative cohort study, and involve two subpopulations based on a genetic marker. We investigate the impact of the following design characteristics: the accrual rate, the time from enrollment to measurement of a short-term outcome and the primary outcome, and the prognostic value of baseline variables and short-term outcomes. To leverage prognostic information in baseline variables and short-term outcomes, we use a semiparametric, locally efficient estimator, and investigate its strengths and limitations compared to standard estimators. We apply information-based monitoring, and evaluate how accurately information can be estimated in an ongoing trial.

  17. Core outcome measurement instruments for clinical trials in non-specific low back pain

    NARCIS (Netherlands)

    Chiarotto, Alessandro; Boers, Maarten; Deyo, Richard A; Buchbinder, Rachelle; Corbin, Terry P; Costa, Leonardo O P; Foster, Nadine E; Grotle, Margreth; Koes, Bart W; Kovacs, Francisco M; Christine Lin, Chung-Wei; Maher, Chris G; Pearson, Adam M; Peul, Wilco C; Schoene, Mark L; Turk, Dennis C; van Tulder, Maurits W; Terwee, Caroline B; Ostelo, Raymond W

    2017-01-01

    To standardize outcome reporting in clinical trials of patients with non-specific low back pain (LBP), an international multidisciplinary panel recommended physical functioning, pain intensity, and health-related quality of life (HRQoL) as core outcome domains. Given the lack of consensus on

  18. Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy

    DEFF Research Database (Denmark)

    Rogozińska, Ewelina; Marlin, Nadine; Yang, Fen

    2017-01-01

    AIM: Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. METHODS: We searched major databases without language restrictions for randomized controlled...... trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting...... as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. RESULTS: Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60...

  19. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review

    DEFF Research Database (Denmark)

    Cordoba Currea, Gloria Cristina; Schwartz, Lisa; Woloshin, Steven

    2010-01-01

    extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component. RESULTS: Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three...... components (range 2-9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of components. We judged that the components were not of similar importance in 28 trials (70%); in 20 of these, death was combined with hospital...

  20. Multimodal Outcome Prognostication After Cardiac Arrest and Targeted Temperature Management: Analysis at 36 °C.

    Science.gov (United States)

    Tsetsou, Spyridoula; Novy, Jan; Pfeiffer, Christian; Oddo, Mauro; Rossetti, Andrea O

    2018-02-01

    Targeted temperature management (TTM) represents the standard of care in comatose survivors after cardiac arrest (CA) and may be applied targeting 33° or 36 °C. While multimodal prognostication has been extensively tested for 33 °C, scarce information exists for 36 °C. In this cohort study, consecutive comatose adults after CA treated with TTM at 36 °C between July 2014 and October 2016 were included. A combination of neurological examination, electrophysiological features, and serum neuron-specific enolase (NSE) was evaluated for outcome prediction at 3 months (mortality; good outcome defined as cerebral performance categories (CPC) score of 1-2, poor outcome defined as CPC 3-5). We analyzed 61 patients. The presence of two or more predictors out of, unreactive electroencephalogram (EEG) background, epileptiform EEG, absent pupillary and/or corneal reflex, early myoclonus, bilaterally absent cortical somatosensory evoked potentials, and serum NSE >75 μg/l, had a high specificity for predicting mortality (positive predictive value [PPV] = 1.00, 95% CI 0.87-1.00) and poor outcome (PPV = 1.00, 95% CI 0.80-1.00). Reactive EEG background was highly sensitive for predicting good outcome (0.95, 95% CI 0.74-0.99). Prediction of outcome after CA and TTM targeting 36 °C seems valid in adults using the same features tested at 33 °C. A reactive EEG under TTM appears highly sensitive for good outcome.

  1. A trial to reduce cardiac motion artifact on HR-CT images of the lung with the use of subsecond scan and special cine reconstruction algorithm

    Energy Technology Data Exchange (ETDEWEB)

    Sakai, Fumikazu; Tsuuchi, Yasuhiko; Suzuki, Keiko; Ueno, Keiko; Yamada, Takayuki; Okawa, Tomohiko [Tokyo Women`s Medical Coll. (Japan); Yun, Shen; Horiuchi, Tetsuya; Kimura, Fumiko

    1998-05-01

    We describe our trial to reduce cardiac motion artifacts on HR-CT images caused by cardiac pulsation by combining use of subsecond CT (scan time 0.8 s) and a special cine reconstruction algorithm (cine reconstruction algorithm with 180-degree helical interpolation). Eleven to 51 HR-CT images were reconstructed with the special cine reconstruction algorithm at the pitch of 0.1 (0.08 s) from the data obtained by two to six contigious rotation scans at the same level. Images with the fewest cardiac motion artifacts were selected for evaluation. These images were compared with those reconstructed with a conventional cine reconstruction algorithm and step-by-step scan. In spite of its increased radiation exposure, technical complexity and slight degradation of spatial resolution, our method was useful in reducing cardiac motion artifacts on HR-CT images in regions adjacent to the heart. (author)

  2. Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: a report from the Cardiac Safety Research Consortium.

    Science.gov (United States)

    Seltzer, Jonathan H; Turner, J Rick; Geiger, Mary Jane; Rosano, Giuseppe; Mahaffey, Kenneth W; White, William B; Sabol, Mary Beth; Stockbridge, Norman; Sager, Philip T

    2015-02-01

    This white paper provides a summary of presentations and discussions at a cardiovascular (CV) end point adjudication think tank cosponsored by the Cardiac Safety Research Committee and the US Food and Drug Administration (FDA) that was convened at the FDA's White Oak headquarters on November 6, 2013. Attention was focused on the lack of clarity concerning the need for end point adjudication in both CV and non-CV trials: there is currently an absence of widely accepted academic or industry standards and a definitive regulatory policy on how best to structure and use clinical end point committees (CECs). This meeting therefore provided a forum for leaders in the fields of CV clinical trials and CV safety to develop a foundation of initial best practice recommendations for use in future CEC charters. Attendees included representatives from pharmaceutical companies, regulatory agencies, end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding when CV end point adjudication should be considered in trials conducted by cardiologists and by noncardiologists as well as detailing key issues in the composition of a CEC and its charter. In addition, it presents several recommended best practices for the establishment and operation of CECs. The science underlying CV event adjudication is evolving, and suggestions for additional areas of research will be needed to continue to advance this science. This manuscript does not constitute regulatory guidance. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    Science.gov (United States)

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

  4. eEduHeart I: A Multicenter, Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-Based eLearning Platform - Rationale and Study Design.

    Science.gov (United States)

    Frederix, Ines; Vandenberk, Thijs; Janssen, Leen; Geurden, Anne; Vandervoort, Pieter; Dendale, Paul

    Cardiac telerehabilitation includes, in its most comprehensive format, telemonitoring, telecoaching, social interaction, and eLearning. The specific role of eLearning, however, was seldom assessed. The aim of eEduHeart I is to investigate the medium-term effectiveness of the addition of a cardiac web-based eLearing platform to conventional cardiac care. In this prospective, multicenter randomized, controlled trial, 1,000 patients with coronary artery disease will be randomized 1:1 to an intervention group (receiving 1-month unrestricted access to the cardiac eLearning platform in addition to conventional cardiac care) or to conventional cardiac care alone. The primary endpoint is health-related quality of life, assessed by the HeartQoL questionnaire at the 1- and 3-month follow-ups. Secondary endpoints include pathology-specific knowledge and self-reported eLearning platform user experience. Data on the eLearning platform usage will be gathered through web logging during the study period. eEduHeart I will be one of the first studies to report on the added value of eLearning. If the intervention is proven effective, current cardiac telerehabilitation programs can be augmented by including eLearning, too. The platform can then be used as a model for other chronic diseases in which patient education plays a key role. © 2016 S. Karger AG, Basel.

  5. Effect of preoperative angina pectoris on cardiac outcomes in patients with previous myocardial infarction undergoing major noncardiac surgery (data from ACS-NSQIP).

    Science.gov (United States)

    Pandey, Ambarish; Sood, Akshay; Sammon, Jesse D; Abdollah, Firas; Gupta, Ena; Golwala, Harsh; Bardia, Amit; Kibel, Adam S; Menon, Mani; Trinh, Quoc-Dien

    2015-04-15

    The impact of preoperative stable angina pectoris on postoperative cardiovascular outcomes in patients with previous myocardial infarction (MI) who underwent major noncardiac surgery is not well studied. We studied patients with previous MI who underwent elective major noncardiac surgeries within the American College of Surgeons-National Surgical Quality Improvement Program (2005 to 2011). Primary outcome was occurrence of an adverse cardiac event (MI and/or cardiac arrest). Multivariable logistic regression models evaluated the impact of stable angina on outcomes. Of 1,568 patients (median age 70 years; 35% women) with previous MI who underwent major noncardiac surgery, 5.5% had postoperative MI and/or cardiac arrest. Patients with history of preoperative angina had significantly greater incidence of primary outcome compared to those without anginal symptoms (8.4% vs 5%, p = 0.035). In secondary outcomes, reintervention rates (22.5% vs 11%, p angina. In multivariable analyses, preoperative angina was a significant predictor for postoperative MI (odds ratio 2.49 [1.20 to 5.58]) and reintervention (odds ratio 2.40 [1.44 to 3.82]). In conclusion, our study indicates that preoperative angina is an independent predictor for adverse outcomes in patients with previous MI who underwent major noncardiac surgery, and cautions against overreliance on predictive tools, for example, the Revised Cardiac Risk Index, in these patients, which does not treat stable angina and previous MI as independent risk factors during risk prognostication. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Analysis of bedside entertainment services' effect on post cardiac surgery physical activity: a prospective, randomised clinical trial.

    Science.gov (United States)

    Papaspyros, Sotiris; Uppal, Shitansu; Khan, Shakeeb A; Paul, Sanjoy; O'Regan, David J

    2008-11-01

    A rising number of acute hospitals in the UK have been providing patients with bedside entertainment services (BES) since 1995. However, their effect on postoperative patient mobility has not been explored. The aim of this prospective randomised clinical trial was to compare the level of postoperative physical activity and length of in-hospital stay of patients undergoing cardiac surgery depending on whether they had access to BES or not. One hundred patients requiring elective cardiac surgery were randomised to receive access to BES (52 patients) or not (48 patients). Pedometers were used to quantify postoperative physical activity for 5 days. To assess the significance of the effect of intervention (TV off or on) on the pedometer counts over time a mixed effect Poisson regression model is used, with the time varying aspect as random component. The potential influence of gender difference and age on pedometer counts were assessed by incorporating these two factors as covariates in the Poisson model. On average, patients with no access to BES walked more than those with BES access. This difference ranged between 192 and 609 steps in favour of the first group for each individual postoperative day. Patients with no access to BES were 84% more likely (risk ratio: 1.84, 95% CI: 1.29-2.63) to walk higher number of steps than patients with access to BES. On average, participants with access to BES were likely to stay longer in hospital (median of 7 days with interquartile range 6-7 days), than participants with no access to BES (median of 6 days with interquartile range 5-7 days), however the difference did not reach statistical significance. We have demonstrated that the bedside entertainment systems may have an adverse effect on post cardiac surgery patient ambulation and may contribute to an increase in hospital stay.

  7. A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials

    DEFF Research Database (Denmark)

    Juhl, Carsten Bogh; Lund, Hans; Guyatt, GH

    2010-01-01

    Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta-analyses ......Title A hierarchy of patient-reported outcome measures for meta-analysis of knee osteoarthritis trials: empirical evidence from a survey of high impact journals Objective To develop a prioritized list for extracting patient-reported outcomes (PROs) measuring pain and disability for meta...... composite disability scores. Conclusions As choosing the most favorable PROs from individual trials can overestimate the effect compared to a systematic approach, using a prioritized list as presented in this study is recommended to reduce reviewer's likelihood of biased selection of PROs in meta-analyses....

  8. Survivorship care plans: are randomized controlled trials assessing outcomes that are relevant to stakeholders?

    Science.gov (United States)

    Birken, Sarah A; Urquhart, Robin; Munoz-Plaza, Corrine; Zizzi, Alexandra R; Haines, Emily; Stover, Angela; Mayer, Deborah K; Hahn, Erin E

    2018-03-23

    The purpose of this study was to compare outcomes assessed in extant randomized controlled trials (RCTs) to outcomes that stakeholders expect from survivorship care plans (SCPs). To facilitate the transition from active treatment to follow-up care for the 15.5 million US cancer survivors, many organizations require SCP use. However, results of several RCTs of SCPs' effectiveness have been null, possibly because they have evaluated outcomes on which SCPs should be expected to have limited influence. Stakeholders (e.g., survivors, oncologists) may expect outcomes that differ from RCTs' outcomes. We identified RCTs' outcomes using a PubMed literature review. We identified outcomes that stakeholders expect from SCPs using semistructured interviews with stakeholders in three healthcare systems in the USA and Canada. Finally, we mapped RCTs' outcomes onto stakeholder-identified outcomes. RCT outcomes did not fully address outcomes that stakeholders expected from SCPs, and RCTs assessed outcomes that stakeholders did not expect from SCPs. RCTs often assessed outcomes only from survivors' perspectives. RCTs of SCPs' effectiveness have not assessed outcomes that stakeholders expect. To better understand SCPs' effectiveness, future RCTs should assess outcomes of SCP use that are relevant from the perspective of multiple stakeholders. SCPs' effectiveness may be optimized when used with an eye toward outcomes that stakeholders expect from SCPs. For survivors, this means using SCPs as a map to guide them with respect to what kind of follow-up care they should seek, when they should seek it, and from whom they should seek it.

  9. Effect of a web-based audit and feedback intervention with outreach visits on the clinical performance of multidisciplinary teams: a cluster-randomized trial in cardiac rehabilitation

    NARCIS (Netherlands)

    Gude, Wouter T.; van Engen-Verheul, Mariëtte M.; van der Veer, Sabine N.; Kemps, Hareld M. C.; Jaspers, Monique W. M.; de Keizer, Nicolette F.; Peek, Niels

    2016-01-01

    The objective of this study was to assess the effect of a web-based audit and feedback (A&F) intervention with outreach visits to support decision-making by multidisciplinary teams. We performed a multicentre cluster-randomized trial within the field of comprehensive cardiac rehabilitation (CR) in

  10. High-Target vs Low-Target Blood Pressure Management During Cardiopulmonary Bypass to Prevent Cerebral Injury in Cardiac Surgery Patients - A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Vedel, Anne G; Holmgaard, Frederik; Rasmussen, Lars S

    2018-01-01

    .71). No significant difference was observed in frequency of severe adverse events. Conclusions -Among patients undergoing on-pump cardiac surgery, targeting a higher versus a lower MAP during cardiopulmonary bypass did not seem to affect the volume or numbers of new cerebral infarcts. Clinical Trial Registration -URL...

  11. Influence of Nitrous Oxide Anesthesia, B-Vitamins, and MTHFR gene polymorphisms on Perioperative Cardiac Events: The Vitamins in Nitrous Oxide (VINO) Randomized Trial

    Science.gov (United States)

    Nagele, Peter; Brown, Frank; Francis, Amber; Scott, Mitchell G.; Gage, Brian F.; Miller, J. Philip

    2013-01-01

    Background Nitrous oxide causes an acute increase in plasma homocysteine that is more pronounced in patients with the MTHFR C677T or A1298C gene variant. In this randomized controlled trial we sought to determine if patients carrying the MTHFR C677T or A1298C variant had a higher risk for perioperative cardiac events after nitrous oxide anesthesia and if this risk could be mitigated by B-vitamins. Methods We randomized adult patients with cardiac risk factors undergoing noncardiac surgery to receive nitrous oxide plus intravenous B-vitamins before and after surgery or to nitrous oxide and placebo. Serial cardiac biomarkers and 12-lead electrocardiograms were obtained. The primary study endpoint was the incidence of myocardial injury, as defined by cardiac troponin I elevation within the first 72 hours after surgery. Results A total of 500 patients completed the trial. Patients who were homozygous for either MTHFR C677T or A1298C gene variant (n= 98; 19.6%) had no increased rate of postoperative cardiac troponin I elevation compared to wild-type and heterozygous patients (11.2% vs. 14.0%; relative risk 0.96, 95% CI 0.85 to 1.07, p=0.48). B-vitamins blunted the rise in homocysteine, but had no effect on cardiac troponin I elevation compared to patients receiving placebo (13.2% vs. 13.6%; relative risk 1.02, 95% CI 0.78 to 1.32, p=0.91). Conclusions Neither MTHFR C677T and A1298C gene variant nor acute homocysteine increase are associated with perioperative cardiac troponin elevation after nitrousoxide anesthesia. B-vitamins blunt nitrous oxide-induced homocysteine increase but have no effect on cardiac troponin elevation. PMID:23856660

  12. Influence of nitrous oxide anesthesia, B-vitamins, and MTHFR gene polymorphisms on perioperative cardiac events: the vitamins in nitrous oxide (VINO) randomized trial.

    Science.gov (United States)

    Nagele, Peter; Brown, Frank; Francis, Amber; Scott, Mitchell G; Gage, Brian F; Miller, J Philip

    2013-07-01

    Nitrous oxide causes an acute increase in plasma homocysteine that is more pronounced in patients with the methylenetetrahydrofolate reductase (MTHFR) C677T or A1298C gene variant. In this randomized controlled trial, the authors sought to determine whether patients carrying the MTHFR C677T or A1298C variant had a higher risk for perioperative cardiac events after nitrous oxide anesthesia and whether this risk could be mitigated by B-vitamins. The authors randomized adult patients with cardiac risk factors undergoing noncardiac surgery, to receive nitrous oxide plus intravenous B-vitamins before and after surgery, or to nitrous oxide and placebo. Serial cardiac biomarkers and 12-lead electrocardiograms were obtained. The primary study endpoint was the incidence of myocardial injury, as defined by cardiac troponin I increase within the first 72 h after surgery. A total of 500 patients completed the trial. Patients who were homozygous for either MTHFR C677T, or A1298C gene variant (n=98; 19.6%) had no increased rate of postoperative cardiac troponin I increase compared with wild-type and heterozygous patients (11.2 vs. 14.0%; relative risk 0.96; 95% CI, 0.85-1.07; P=0.48). B-vitamins blunted the rise in homocysteine, but had no effect on cardiac troponin I increase compared with patients receiving placebo (13.2 vs. 13.6%; relative risk 1.02; 95% CI 0.78 to 1.32; P=0.91). Neither MTHFR C677T and A1298C gene variant, nor acute homocysteine increase are associated with perioperative cardiac troponin increase after nitrous oxide anesthesia. B-vitamins blunt nitrous oxide-induced homocysteine increase but have no effect on cardiac troponin I increase.

  13. Massed Trials versus Trials Embedded into Game Play: Child Outcomes and Preference

    Science.gov (United States)

    Ledford, Jennifer R.; Chazin, Kate T.; Harbin, Emilee R.; Ward, Sarah E.

    2017-01-01

    Limited data are available regarding how response prompting procedures should be used in early childhood settings. The purpose of this study was to compare the efficiency of progressive time delay instruction presented via two trial arrangements: massed and embedded. During massed trial sessions, a short instructional session was conducted,…

  14. Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials.

    Science.gov (United States)

    Hopewell, Sally; Witt, Claudia M; Linde, Klaus; Icke, Katja; Adedire, Olubusola; Kirtley, Shona; Altman, Douglas G

    2018-01-11

    Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials. Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics. Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the

  15. Comparative effectiveness of coronary CT angiography vs stress cardiac imaging in patients following hospital admission for chest pain work-up: The Prospective First Evaluation in Chest Pain (PERFECT) Trial.

    Science.gov (United States)

    Uretsky, Seth; Argulian, Edgar; Supariwala, Azhar; Agarwal, Shiv K; El-Hayek, Georges; Chavez, Patricia; Awan, Hira; Jagarlamudi, Ashadevi; Puppala, Siva P; Cohen, Randy; Rozanski, Alan

    2017-08-01

    Because the frequency of cardiac event rates is low among chest pain patients following either performance of coronary CT angiography (CCTA) or stress testing, there is a need to better assess how these tests influence the central management decisions that follow from cardiac testing. The present study was performed to assess the relative impact of CCTA vs stress testing on medical therapies and downstream resource utilization among patients admitted for the work-up of chest pain. The admitted patients were randomized in a 1:1 ratio to either cardiac imaging stress test or CCTA. Primary outcomes were time to discharge, change in medication usage, and frequency of downstream testing, cardiac interventions, and cardiovascular re-hospitalizations. We randomized 411 patients, 205 to stress testing, and 206 to CCTA. There were no differences in time to discharge or initiation of new cardiac medications at discharge. At 1 year follow-up, there was no difference in the number of patients who underwent cardiovascular downstream tests in the CCTA vs stress test patients (21% vs 15%, P = .1) or cardiovascular hospitalizations (14% vs 16%, P = .5). However, there was a higher frequency of invasive angiography in the CCTA group (11% vs 2%, P = .001) and percutaneous coronary interventions (6% vs 0%, P work-up to either CCTA or to stress testing resulted in similar discharge times, change in medical therapies at discharge, frequency of downstream noninvasive testing, and repeat hospitalizations. However, a higher frequency of invasive coronary angiography and revascularization procedures were performed in the CCTA arm. (ClinicalTrials.gov number, NCT01604655.).

  16. Impact of perioperative blood pressure variability on health resource utilization after cardiac surgery: an analysis of the ECLIPSE trials.

    Science.gov (United States)

    Aronson, Solomon; Levy, Jerrold H; Lumb, Philip D; Fontes, Manuel; Wang, Yamei; Crothers, Tracy A; Sulham, Katherine A; Navetta, Marco S

    2014-06-01

    To examine the impact of blood pressure control on hospital health resource utilization using data from the ECLIPSE trials. Post-hoc analysis of data from 3 prospective, open-label, randomized clinical trials (ECLIPSE trials). Sixty-one medical centers in the United States. Patients 18 years or older undergoing cardiac surgery. Clevidipine was compared with nitroglycerin, sodium nitroprusside, and nicardipine. The ECLIPSE trials included 3 individual randomized open-label studies comparing clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine. Blood pressure control was assessed as the integral of the cumulative area under the curve (AUC) outside specified systolic blood pressure ranges, such that lower AUC represents less variability. This analysis examined surgery duration, time to extubation, as well as intensive care unit (ICU) and hospital length of stay (LOS) in patients with AUC≤10 mmHg×min/h compared to patients with AUC>10 mmHg×min/h. One thousand four hundred ten patients were included for analysis; 736 patients (52%) had an AUC≤10 mmHg×min/h, and 674 (48%) had an AUC>10 mmHg×min/h. The duration of surgery and ICU LOS were similar between groups. Time to extubation and postoperative LOS were both significantly shorter (p = 0.05 and pAUC≤10. Multivariate analysis demonstrates AUC≤10 was significantly and independently associated with decreased time to extubation (hazard ratio 1.132, p = 0.0261) and postoperative LOS (hazard ratio 1.221, p = 0.0006). Based on data derived from the ECLIPSE studies, increased perioperative BP variability is associated with delayed time to extubation and increased postoperative LOS. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Comparison between the outcome of trial of labour and elective ...

    African Journals Online (AJOL)

    Foetal outcome was assessed based on APGAR score at five minutes, need for admission to the new born unit and the occurrence of early neonatal death. Results: A total of 142 participants were recruited of which 71 had undergone TOL and 71 had undergone ERCS. Clinical pelvimetry was the most common criteria used ...

  18. The interrelationship between preoperative anemia and N-terminal pro-B-type natriuretic peptide: the effect on predicting postoperative cardiac outcome in vascular surgery patients.

    Science.gov (United States)

    Goei, Dustin; Flu, Willem-Jan; Hoeks, Sanne E; Galal, Wael; Dunkelgrun, Martin; Boersma, Eric; Kuijper, Ruud; van Kuijk, Jan-Peter; Winkel, Tamara A; Schouten, Olaf; Bax, Jeroen J; Poldermans, Don

    2009-11-01

    N-terminal pro-B-type natriuretic peptide (NT-proBNP) predicts adverse cardiac outcome in patients undergoing vascular surgery. However, several conditions might influence this prognostic value, including anemia. In this study, we evaluated whether anemia confounds the prognostic value of NT-proBNP for predicting cardiac events in patients undergoing vascular surgery. A detailed cardiac history, resting echocardiography, and hemoglobin and NT-proBNP levels were obtained in 666 patients before vascular surgery. Anemia was defined as serum hemoglobin value of NT-proBNP for the prediction of the composite end point. Multivariable regression analysis was used to assess the additional value of NT-proBNP for the prediction of postoperative cardiac events in nonanemic and anemic patients. Anemia was present in 206 patients (31%) before surgery. Hemoglobin level was inversely related with the NT-proBNP levels (beta coefficient = -2.242; P = 0.025). The optimal predictive cutoff value of NT-proBNP for predicting the composite cardiovascular outcome was 350 pg/mL. After adjustment for clinical cardiac risk factors, both anemia (odds ratio [OR] 1.53; 95% confidence interval [CI]: 1.07-2.99) and increased levels of NT-proBNP (OR 4.09; 95% CI: 2.19-7.64) remained independent predictors for postoperative cardiac events. However, increased levels of NT-proBNP were not predictive for the risk of adverse cardiac events in the subgroup of anemic patients (OR 2.16; 95% CI: 0.90-5.21). Both anemia and NT-proBNP are independently associated with an increased risk for postoperative cardiac events in patients undergoing vascular surgery. NT-proBNP has less predictive value in anemic patients.

  19. Clinical islet isolation and transplantation outcomes with deceased cardiac death donors are similar to neurological determination of death donors.

    Science.gov (United States)

    Andres, Axel; Kin, Tatsuya; O'Gorman, Doug; Livingstone, Scott; Bigam, David; Kneteman, Norman; Senior, Peter; Shapiro, A M James

    2016-01-01

    In islet transplantation, deceased cardiac death (DCD) donation has been identified as a potential extended source. There are currently no studies comparing outcomes between these categories, and our goal was to compare islet isolation success rates and transplantation outcomes between DCD and neurological determination of death (NDD) donors. Islet isolations from 15 DCD and 418 NDD were performed in our centre between September 2008 and September 2014. Donor variables, islet yields, metabolic function of isolated isled and insulin requirements at 1-month post-transplant were compared. Compared to NDD, pancreata from DCD were more often procured locally and donors required less vasopressive support (P islet yields were similar between NDD and DCD (576 vs. 608 × 10(3) islet equivalent, P = 0.628 and 386 vs. 379, P = 0.881, respectively). The metabolic function was similar between NDD and DCD, as well as the mean decrease in insulin requirement at 1-month post-transplantation (NDD: 64.82%; DCD: 60.17% reduction, P = 0.517). These results support the broader use of DCD pancreata for islet isolation. A much larger DCD islet experience will be required to truly determine noninferiority of both short- and long-term outcomes. © 2015 Steunstichting ESOT.

  20. Randomized trials, generalizability, and meta-analysis: Graphical insights for binary outcomes

    Directory of Open Access Journals (Sweden)

    Kramer Barnett S

    2003-06-01

    Full Text Available Abstract Background Randomized trials stochastically answer the question. "What would be the effect of treatment on outcome if one turned back the clock and switched treatments in the given population?" Generalizations to other subjects are reliable only if the particular trial is performed on a random sample of the target population. By considering an unobserved binary variable, we graphically investigate how randomized trials can also stochastically answer the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?" Method For three different outcome measures, absolute difference (DIF, relative risk (RR, and odds ratio (OR, we constructed a modified BK-Plot under the assumption that treatment has the same effect on outcome if either all or no subjects had a given level of the unobserved binary variable. (A BK-Plot shows the effect of an unobserved binary covariate on a binary outcome in two treatment groups; it was originally developed to explain Simpsons's paradox. Results For DIF and RR, but not OR, the BK-Plot shows that the estimated treatment effect is invariant to the fraction of subjects with an unobserved binary variable at a given level. Conclusion The BK-Plot provides a simple method to understand generalizability in randomized trials. Meta-analyses of randomized trials with a binary outcome that are based on DIF or RR, but not OR, will avoid bias from an unobserved covariate that does not interact with treatment in its effect on outcome.

  1. Trial protocol OPPTIMUM– Does progesterone prophylaxis for the prevention of preterm labour improve outcome?

    Directory of Open Access Journals (Sweden)

    Norman Jane E

    2012-08-01

    Full Text Available Abstract Background Preterm birth is a global problem, with a prevalence of 8 to 12% depending on location. Several large trials and systematic reviews have shown progestogens to be effective in preventing or delaying preterm birth in selected high risk women with a singleton pregnancy (including those with a short cervix or previous preterm birth. Although an improvement in short term neonatal outcomes has been shown in some trials these have not consistently been confirmed in meta-analyses. Additionally data on longer term outcomes is limited to a single trial where no difference in outcomes was demonstrated at four years of age of the child, despite those in the “progesterone” group having a lower incidence of preterm birth. Methods/Design The OPPTIMUM study is a double blind randomized placebo controlled trial to determine whether progesterone prophylaxis to prevent preterm birth has long term neonatal or infant benefit. Specifically it will study whether, in women with singleton pregnancy and at high risk of preterm labour, prophylactic vaginal natural progesterone, 200 mg daily from 22 – 34 weeks gestation, compared to placebo, improves obstetric outcome by lengthening pregnancy thus reducing the incidence of preterm delivery (before 34 weeks, improves neonatal outcome by reducing a composite of death and major morbidity, and leads to improved childhood cognitive and neurosensory outcomes at two years of age. Recruitment began in 2009 and is scheduled to close in Spring 2013. As of May 2012, over 800 women had been randomized in 60 sites. Discussion OPPTIMUM will provide further evidence on the effectiveness of vaginal progesterone for prevention of preterm birth and improvement of neonatal outcomes in selected groups of women with singleton pregnancy at high risk of preterm birth. Additionally it will determine whether any reduction in the incidence of preterm birth is accompanied by improved childhood outcome. Trial

  2. Outcome when adrenaline (epinephrine) was actually given vs. not given - post hoc analysis of a randomized clinical trial.

    Science.gov (United States)

    Olasveengen, Theresa M; Wik, Lars; Sunde, Kjetil; Steen, Petter A

    2012-03-01

    IV line insertion and drugs did not affect long-term survival in an out-of-hospital cardiac arrest (OHCA) randomized clinical trial (RCT). In a previous large registry study adrenaline was negatively associated with survival from OHCA. The present post hoc analysis on the RCT data compares outcomes for patients actually receiving adrenaline to those not receiving adrenaline. Patients from a RCT performed May 2003 to April 2008 were included. Three patients from the original intention-to-treat analysis were excluded due to insufficient documentation of adrenaline administration. Quality of cardiopulmonary resuscitation (CPR) and clinical outcomes were compared. Clinical characteristics were similar and CPR quality comparable and within guideline recommendations for 367 patients receiving adrenaline and 481 patients not receiving adrenaline. Odds ratio (OR) for being admitted to hospital, being discharged from hospital and surviving with favourable neurological outcome for the adrenaline vs. no-adrenaline group was 2.5 (CI 1.9, 3.4), 0.5 (CI 0.3, 0.8) and 0.4 (CI 0.2, 0.7), respectively. Ventricular fibrillation, response interval, witnessed arrest, gender, age and endotracheal intubation were confounders in multivariate logistic regression analysis. OR for survival for adrenaline vs. no-adrenaline adjusted for confounders was 0.52 (95% CI: 0.29, 0.92). Receiving adrenaline was associated with improved short-term survival, but decreased survival to hospital discharge and survival with favourable neurological outcome after OHCA. This post hoc survival analysis is in contrast to the previous intention-to-treat analysis of the same data, but agrees with previous non-randomized registry data. This shows limitations of non-randomized or non-intention-to-treat analyses. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  3. From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology

    Science.gov (United States)

    Raghav, Kanwal Pratap Singh; Mahajan, Sminil; Yao, James C.; Hobbs, Brian P.; Berry, Donald A.; Pentz, Rebecca D.; Tam, Alda; Hong, Waun K.; Ellis, Lee M.; Abbruzzese, James; Overman, Michael J.

    2015-01-01

    Purpose The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data. Methods We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses. Results A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end point. Nine trials (12.2%) had some discrepancy between their planned and published primary end points. A total of 579 nonprimary end points (median, seven per trial) were planned, of which 373 (64.4%; median, five per trial) were reported. A significant positive correlation was found between the number of planned and nonreported nonprimary end points (Spearman r = 0.66; P < .001). Twenty-eight studies (37.8%) reported a total of 65 unplanned end points; 52 (80.0%) of which were not identified as unplanned. Thirty-one (41.9%) and 19 (25.7%) of 74 trials reported a total of 52 unplanned analyses involving primary end points and 33 unplanned analyses involving nonprimary end points, respectively. Studies reported positive unplanned end points and unplanned analyses more frequently than negative outcomes in abstracts (unplanned end points odds ratio, 6.8; P = .002; unplanned analyses odd ratio, 8.4; P = .007). Conclusion Despite public and reviewer access to protocols, selective outcome reporting persists and is a major concern in the reporting of randomized clinical trials. To foster credible evidence-based medicine, additional initiatives are needed to minimize selective reporting. PMID:26304898

  4. Patient-reported outcome (PRO assessment in clinical trials: a systematic review of guidance for trial protocol writers.

    Directory of Open Access Journals (Sweden)

    Melanie Calvert

    Full Text Available Evidence suggests there are inconsistencies in patient-reported outcome (PRO assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013 for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts. 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3% recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in

  5. Self-declared stock ownership and association with positive trial outcome in randomized controlled trials with binary outcomes published in general medical journals: a cross-sectional study.

    Science.gov (United States)

    Falk Delgado, Alberto; Falk Delgado, Anna

    2017-07-26

    Describe the prevalence and types of conflicts of interest (COI) in published randomized controlled trials (RCTs) in general medical journals with a binary primary outcome and assess the association between conflicts of interest and favorable outcome. Parallel-group RCTs with a binary primary outcome published in three general medical journals during 2013-2015 were identified. COI type, funding source, and outcome were extracted. Binomial logistic regression model was performed to assess association between COI and funding source with outcome. A total of 509 consecutive parallel-group RCTs were included in the study. COI was reported in 74% in mixed funded RCTs and in 99% in for-profit funded RCTs. Stock ownership was reported in none of the non-profit RCTs, in 7% of mixed funded RCTs, and in 50% of for-profit funded RCTs. Mixed-funded RCTs had employees from the funding company in 11% and for-profit RCTs in 76%. Multivariable logistic regression revealed that stock ownership in the funding company among any of the authors was associated with a favorable outcome (odds ratio = 3.53; 95% confidence interval = 1.59-7.86; p < 0.01). COI in for-profit funded RCTs is extensive, because the factors related to COI are not fully independent, a multivariable analysis should be cautiously interpreted. However, after multivariable adjustment only stock ownership from the funding company among authors is associated with a favorable outcome.

  6. Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing: A Reproduction Analysis of the SMART-AF Trial.

    Science.gov (United States)

    Gay, Hawkins C; Baldridge, Abigail S; Huffman, Mark D

    2017-12-01

    Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise. To evaluate the feasibility, process, and outcomes of a reproduction analysis of the THERMOCOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial using shared clinical trial data. A reproduction analysis of the SMART-AF trial was performed using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed through the Yale Open Data Access Project using the SAS Clinical Trials Data Transparency platform. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. Analysis of the data was conducted between December 2016 and April 2017. Effectiveness outcomes included freedom from atrial arrhythmias after ablation and proportion of participants without any arrhythmia recurrence over the 12 months of follow-up after a 3-month blanking period. Safety outcomes included major adverse device- or procedure-related events. The SMART AF trial participants' mean age was 58.7 (10.8) years, and 72% were men. The time from initial proposal submission to final analysis was 11 months. Freedom from atrial arrhythmias at 12 months postprocedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the 2 analyses, but contact force range or regression models could not be reproduced. The feasibility of a reproduction analysis of the SMART-AF trial was demonstrated through an academic data-sharing platform. Data sharing can be

  7. Differences in Presentation, Management and Outcomes in Women and Men Presenting to an Emergency Department With Possible Cardiac Chest Pain.

    Science.gov (United States)

    Ruane, Lorcan; H Greenslade, Jaimi; Parsonage, William; Hawkins, Tracey; Hammett, Christopher; Lam, Carolyn Sp; Knowlman, Thomas; Doig, Shaela; Cullen, Louise

    2017-12-01

    Research suggests that female patients with acute coronary syndrome (ACS) experience delays in emergency department (ED) management and are less likely to receive guideline-based treatments and referrals for follow-up testing. Women are often found to have poorer clinical outcomes in comparison to men. This study aimed to assess current sex differences in the presentation, management and outcomes of patients with undifferentiated chest pain presenting to a tertiary ED. Data were analysed from two prospective studies conducted at a single Australian site between 2007 and 2014. Eligible patients were those of 18 years of age or older presenting with at least 5 minutes of chest pain or other symptoms for which the treating physician planned to investigate for possible ACS. Presenting symptoms, ED time measures, follow-up testing and outcomes, including 30-day ACS and mortality, were measured and compared between male and female patients. Of 2349 (60% men) patients presenting with chest pain, 153 men and 51 women were diagnosed with ACS within 30days . Presenting symptoms were similar in men and women with confirmed ACS. Time from symptom onset to ED presentation, time spent in the ED and total time in hospital were similar between the sexes. Male and female patients had similar rates of follow-up provocative testing. After adjustment for clinical factors, the odds of undergoing angiography were 1.8 (95% CI: 1.36-2.40) times higher for men than women. Of those undergoing coronary angiography within 30 days, a smaller proportion of women, compared to men, received revascularisation. Within 30 days, three (0.2%) male and one (0.1%) female patient died. Minimal sex differences were observed in the contemporary emergency management of patients presenting with suspected ACS. Thirty-day outcomes were similarly low in men and women despite lower rates of coronary angiography and revascularisation in women. Further research is required to replicate these results in different

  8. Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial

    DEFF Research Database (Denmark)

    Winkel, Per; Hilden, J; Hansen, Jørgen Fischer

    2011-01-01

    Objectives: To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease. Methods: Cox analyses using out-of-hospital death as a proxy for sudden death compared to in-hospital...... CV death in patients not on statins at trial entry (HR: 2.61, 95% CI: 1.69–4.05, p administration was significantly associated with increased risk of sudden CV death in stable...

  9. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study.

    NARCIS (Netherlands)

    Amant, F.; Calsteren, K. van; Halaska, M.J.; Gziri, M.M.; Hui, W.; Lagae, L.; Willemsen, M.A.A.P.; Kapusta, L.; Calster, B. van; Wouters, H; Heyns, L.; Han, S.N.; Tomek, V.; Mertens, L.; Ottevanger, P.B.

    2012-01-01

    BACKGROUND: Chemotherapy for the treatment of maternal cancers during pregnancy has become more acceptable in the past decade; however, the effect of prenatal exposure to chemotherapy on cardiac and neurodevelopmental outcomes of the offspring is still uncertain. We aimed to record the general

  10. Apples to apples or apples to oranges? International variation in reporting of process and outcome of care for out-of-hospital cardiac arrest

    NARCIS (Netherlands)

    Nishiyama, Chika; Brown, Siobhan P.; May, Susanne; Iwami, Taku; Koster, Rudolph W.; Beesems, Stefanie G.; Kuisma, Markku; Salo, Ari; Jacobs, Ian; Finn, Judith; Sterz, Fritz; Nürnberger, Alexander; Smith, Karen; Morrison, Laurie; Olasveengen, Theresa M.; Callaway, Clifton W.; Shin, Sang Do; Gräsner, Jan-Thorsten; Daya, Mohamud; Ma, Matthew Huei-Ming; Herlitz, Johan; Strömsöe, Anneli; Aufderheide, Tom P.; Masterson, Siobhán; Wang, Henry; Christenson, Jim; Stiell, Ian; Davis, Dan; Huszti, Ella; Nichol, Graham

    2014-01-01

    Survival after out-of-hospital cardiac arrest (OHCA) varies between communities, due in part to variation in the methods of measurement. The Utstein template was disseminated to standardize comparisons of risk factors, quality of care, and outcomes in patients with OHCA. We sought to assess whether

  11. Spectral pulsed-wave tissue Doppler imaging lateral-to-septal delay fails to predict clinical or echocardiographic outcome after cardiac resynchronization therapy

    NARCIS (Netherlands)

    O.I.I. Soliman (Osama Ibrahim Ibrahim); D.A.M.J. Theuns (Dominic); M.L. Geleijnse (Marcel); A. Nemes (Attila); K. Caliskan (Kadir); W.B. Vletter (Wim); L.J.L.M. Jordaens (Luc); F.J. ten Cate (Folkert)

    2007-01-01

    textabstractAims: The current study sought to assess if pre-implantation lateral-to-septal delay (LSD) ≥60 ms assessed by spectral pulsed-wave myocardial tissue Doppler imaging (PW-TDI) could predict successful long-term outcome after cardiac resynchronization therapy (CRT). Methods and results

  12. Comparing Outcomes of Donation After Cardiac Death Versus Donation After Brain Death in Liver Transplant Recipients with Hepatitis C: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Malcolm Wells

    2014-01-01

    Full Text Available BACKGROUND: Liver transplantation (LT using organs donated after cardiac death (DCD is increasing due, in large part, to a shortage of organs. The outcome of using DCD organs in recipients with hepatits C virus (HCV infection remains unclear due to the limited experience and number of publications addressing this issue.

  13. Impact of Site Selection and Study Conduct on Outcomes in Global Clinical Trials.

    Science.gov (United States)

    Sarwar, Chaudhry M S; Vaduganathan, Muthiah; Butler, Javed

    2017-08-01

    There are over 25 million patients living with heart failure globally. Overall, and especially post-discharge, clinical outcomes have remained poor in heart failure despite multiple trials, with both successes and failures over the last two decades. Matching therapies to the right patient population, identifying high-quality sites, and ensuring optimal trial design and execution represent important considerations in the development of novel therapeutics in this space. While clinical trials have undergone rapid globalization, this has come with regional variation in comorbidities, clinical parameters, and even clinical outcomes and treatment effects across international sites. These issues have now highlighted knowledge gaps about the conduct of trials, selection of study sites, and an unmet need to develop and identify "ideal" sites. There is a need for all stakeholders, including academia, investigators, healthcare organizations, patient advocacy groups, industry sponsors, research organizations, and regulatory authorities, to work as a multidisciplinary group to address these problems and develop practical solutions to improve trial conduct, efficiency, and execution. We review these trial-level issues using examples from contemporary studies to inform and optimize the design of future global clinical trials in heart failure.

  14. Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

    Science.gov (United States)

    Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

    2015-12-01

    Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  15. Trial of quantitative analysis of cardiac function by 3D reconstruction of multislice cine MR images

    International Nuclear Information System (INIS)

    Yamamoto, Hideki; Sei, Tetsurou; Nakagawa, Tomio; Hiraki, Yoshio.

    1994-01-01

    Non-invasive techniques for measuring the dynamic behavior of the left ventricle (LV) can be invaluable tool in the diagnosis of the heart disease. In this paper we present methods for quantitative analysis of cardiac function using a compact magnetic resonance image processing system. A 256 x 256 magnetic resonance transaxial image of the left ventricle in a normal case is obtained. After gray level thresholding and region segmentation, the boundary of the left ventricular chamber is extracted. Then, the boundaries of the left ventricular chamber are displayed three-dimensionally by using the Z-buffer algorithm. Thus, LV volume and ejection fraction are calculated. Here, the value of LV ejection fraction is 60%. These results agree reasonably well with the corresponding data obtained by the echocardiography. (author)

  16. Technology-Enabled Remote Monitoring and Self-Management - Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol.

    Science.gov (United States)

    McGillion, Michael; Yost, Jennifer; Turner, Andrew; Bender, Duane; Scott, Ted; Carroll, Sandra; Ritvo, Paul; Peter, Elizabeth; Lamy, Andre; Furze, Gill; Krull, Kirsten; Dunlop, Valerie; Good, Amber; Dvirnik, Nazari; Bedini, Debbie; Naus, Frank; Pettit, Shirley; Henry, Shaunattonie; Probst, Christine; Mills, Joseph; Gossage, Elaine; Travale, Irene; Duquette, Janine; Taberner, Christy; Bhavnani, Sanjeev; Khan, James S; Cowan, David; Romeril, Eric; Lee, John; Colella, Tracey; Choinière, Manon; Busse, Jason; Katz, Joel; Victor, J Charles; Hoch, Jeffrey; Isaranuwatchai, Wanrudee; Kaasalainen, Sharon; Ladak, Salima; O'Keefe-McCarthy, Sheila; Parry, Monica; Sessler, Daniel I; Stacey, Michael; Stevens, Bonnie; Stremler, Robyn; Thabane, Lehana; Watt-Watson, Judy; Whitlock, Richard; MacDermid, Joy C; Leegaard, Marit; McKelvie, Robert; Hillmer, Michael; Cooper, Lynn; Arthur, Gavin; Sider, Krista; Oliver, Susan; Boyajian, Karen; Farrow, Mark; Lawton, Chris; Gamble, Darryl; Walsh, Jake; Field, Mark; LeFort, Sandra; Clyne, Wendy; Ricupero, Maria; Poole, Laurie; Russell-Wood, Karsten; Weber, Michael; McNeil, Jolene; Alpert, Robyn; Sharpe, Sarah; Bhella, Sue; Mohajer, David; Ponnambalam, Sem; Lakhani, Naeem; Khan, Rabia; Liu, Peter; Devereaux, P J

    2016-08-01

    Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT-VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom. Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT). CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative

  17. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care).

    Science.gov (United States)

    Cavender, Matthew A; White, William B; Jarolim, Petr; Bakris, George L; Cushman, William C; Kupfer, Stuart; Gao, Qi; Mehta, Cyrus R; Zannad, Faiez; Cannon, Christopher P; Morrow, David A

    2017-05-16

    We aimed to describe the relationship between changes in high-sensitivity cardiac troponin I (hsTnI) and cardiovascular outcomes. The EXAMINE trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care) was a phase IIIb clinical outcomes trial designed to evaluate the cardiovascular safety of alogliptin, a nonselective dipeptidyl peptidase 4 inhibitor. Patients with type 2 diabetes mellitus, glycohemoglobin between 6.5% and 11% (or between 7% and 11% if they were on insulin), and a recent acute coronary syndrome (between 15 and 90 days before randomization) were eligible for the trial. hsTnI was measured using the Abbott ARCHITECT assay at baseline and 6 months in patients randomized in the EXAMINE trial. This analysis was restricted to patients randomized ≥30 days after qualifying acute coronary syndrome to mitigate the potential for persistent hsTnI elevation after acute coronary syndrome (n=3808). The primary end point of the trial was cardiovascular death, myocardial infarction, or stroke. Cardiovascular death or heart failure was a prespecified, adjudicated secondary end point. At baseline, hsTnI was detectable (≥1.9 ng/L) in 93% of patients and >99 th percentile upper reference limit in 16%. There was a strong relationship between increasing hsTnI, both at baseline and 6 months, and the incidence of cardiovascular events through 24 months ( P diabetes mellitus without clinically recognized events had dynamic or persistently elevated values and were at high risk of recurrent events. hsTnI may have a role in personalizing preventive strategies in patients with diabetes mellitus based on risk. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00968708. © 2017 American Heart Association, Inc.

  18. Outcomes of clinical trial: tinnitus masking versus tinnitus retraining therapy.

    Science.gov (United States)

    Henry, James A; Schechter, Martin A; Zaugg, Tara L; Griest, Susan; Jastreboff, Pawel J; Vernon, Jack A; Kaelin, Christine; Meikle, Mary B; Lyons, Karen S; Stewart, Barbara J

    2006-02-01

    A controlled clinical study was conducted to evaluate prospectively the clinical efficacy of tinnitus masking (TM) and tinnitus retraining therapy (TRT) in military veterans having clinically significant tinnitus. Qualifying patients were placed into the two groups in an alternating manner (to avoid selection bias), and treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index) and the verbally administered TRT interview forms. Findings are presented from the three written questionnaires, and from two of the interview questions (percentage time aware of, and annoyed by, tinnitus). Outcomes were analyzed on an intent-to-treat basis, using a multilevel modeling approach. Of the 123 patients enrolled, 118 were included in the analysis. Both groups showed significant declines (improvements) on these measures, with the TRT decline being significantly greater than for TM. The greater declines in TRT compared to TM occurred most strongly in patients who began treatment with a "very big" tinnitus problem. When patients began treatment with a "moderate" tinnitus problem, the benefits of TRT compared to TM were more modest.

  19. Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review.

    Science.gov (United States)

    Gaudry, Stéphane; Messika, Jonathan; Ricard, Jean-Damien; Guillo, Sylvie; Pasquet, Blandine; Dubief, Emeline; Boukertouta, Tanissia; Dreyfuss, Didier; Tubach, Florence

    2017-12-01

    Intensivists' clinical decision making pursues two main goals for patients: to decrease mortality and to improve quality of life and functional status in survivors. Patient-important outcomes are gaining wide acceptance in most fields of clinical research. We sought to systematically review how well patient-important outcomes are reported in published randomized controlled trials (RCTs) in critically ill patients. Literature search was conducted to identify eligible trials indexed from January to December 2013. Articles were eligible if they reported an RCT involving critically ill adult patients. We excluded phase II, pilot and physiological crossover studies. We assessed study characteristics. All primary and secondary outcomes were collected, described and classified using six categories of outcomes including patient-important outcomes (involving mortality at any time on the one hand and quality of life, functional/cognitive/neurological outcomes assessed after ICU discharge on the other). Of the 716 articles retrieved in 2013, 112 RCTs met the inclusion criteria. Most common topics were mechanical ventilation (27%), sepsis (19%) and nutrition (17%). Among the 112 primary outcomes, 27 (24%) were patient-important outcomes (mainly mortality, 21/27) but only six (5%) were patient-important outcomes besides mortality assessed after ICU discharge (functional disability = 4; quality of life = 2). Among the 598 secondary outcomes, 133 (22%) were patient-important outcomes (mainly mortality, 92/133) but only 41 (7%) were patient-important outcomes besides mortality assessed after ICU discharge (quality of life = 20, functional disability = 14; neurological/cognitive performance = 5; handicap = 1; post-traumatic stress = 1). Seventy-three RCTs (65%) reported at least one patient-important outcome but only 11 (10%) reported at least one patient-important outcome besides mortality assessed after ICU discharge. Patient-important outcomes are rarely primary

  20. Outcomes in cardiac surgery in 500 consecutive Jehovah's Witness patients: 21 year Experience

    Directory of Open Access Journals (Sweden)

    Vaislic Claude D

    2012-09-01

    Full Text Available Abstract Background Refusal of heterogenic blood products can be for religious reasons as in Jehovah's Witnesses or otherwise or as requested by an increasing number of patients. Furthermore blood reserves are under continuous demand with increasing costs. Therefore, transfusion avoidance strategies are desirable. We describe a historic comparison and current results of blood saving protocols in Jehovah's Witnesses patients. Methods Data on 250 Jehovah's Witness patients operated upon between 1991 and 2003 (group A were reviewed and compared with a second population of 250 patients treated from 2003 to 2012 (group B. Results In group A, mean age was 51 years of age compared to 68 years in group B. An iterative procedure was performed in 13% of patients in group B. Thirty days mortality was 3% in group A and 1% in group B despite greater operative risk factors, with more redo, and lower ejection fraction in group B. Several factors contributed to the low morbidity-mortality in group B, namely: preoperative erythropoietin to attain a minimal hemoglobin value of 14 g/dl, warm blood cardioplegia, the implementation of the Cornell University protocol and fast track extubation. Conclusions Cardiac surgery without transfusion in high-risk patients such as Jehovah Witnesses can be carried out with results equivalent to those of low risk patients. Recent advances in surgical techniques and blood conservation protocols are main contributing factors.

  1. Predictors and outcomes of cardiac resynchronization therapy extended to the second generator.

    Science.gov (United States)

    Li, Xuping; Yang, Dachun; Kusumoto, Fred; Shen, Win-Kuang; Mulpuru, Siva; Zhou, Shenghua; Liang, Jinjun; Wu, Gang; Yang, Mei; Liu, Jin-Qu; Friedman, Paul A; Cha, Yong-Mei

    2017-12-01

    A proportion of patients who receive cardiac resynchronization therapy with defibrillator (CRT-D) live to receive a second generator. Controversy exists on whether an implantable cardioverter-defibrillator (ICD) should be offered to patients who have normalized or near-normalized left ventricular ejection fraction (LVEF) at the time of generator replacement (GR). The purpose of this study was to evaluate incidence of appropriate ICD therapy after CRT-D GR. This series involved 1026 consecutive patients who underwent CRT-D implant between January 1, 2002 and December 31, 2012. Echocardiography was assessed before the initial device implant and before GR. ICDs were monitored at our device clinic in person or remotely, or both. Of the cohort, 227 patients (22.1%) underwent CRT-D GR at our institution. Approximately 48% of the patients who received new CRT-D generators were no longer meeting the guidelines indication for ICD use at the time of GR. These patients received subsequent appropriate ICD therapies at a significantly lower rate than those with LVEF generator after GR. Improvement in LVEF after CRT-D GR is associated with significantly reduced incidence of appropriate ICD therapy. Ventricular arrhythmia is less likely to develop with normalized LVEF in nonischemic cardiomyopathy. Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  2. Clinical Outcomes of Different Tempos of Music During Exercise in Cardiac Rehabilitation Patients.

    Science.gov (United States)

    Miller, Jarad S; Terbizan, Donna J

    2017-01-01

    This study examined the effects of stimulating and sedative music on ratings of perceived exertion (RPE), heart rate (HR), blood pressure (BP), and feeling status during exercise in cardiac rehabilitation (CR) patients. Twenty-two male and female older adults age 64 ± 8.0 y currently enrolled in phase III CR completed the study. Repeated measures crossover designs guided data collection. The manipulated independent variable was music condition (sedative, stimulating, and non-music control). The dependent variables were RPE, BP, HR, and feeling status with each represented by four repeated measures ANOVAs over time via SAS 9.3. Data analysis indicated significant differences for all exercise related variables besides BP. While standardizing the exercise, we observed that sedative music is the best choice to manipulate for decreases in RPE (p=.0019), increases in feeling status (p=.0192), and decreases in HR (pmusic is the best choice to observe decreases in RPE, increases in feeling status, and decreases HR. Stimulating music would only be the correct choice to observe increases in HR, and does not have as much of a beneficial effect on RPE and feeling status as sedative music. There were no significant effects of either type of music on BP.

  3. Relation of Left Atrial Size, Cardiac Morphology, and Clinical Outcome in Asymptomatic Aortic Stenosis

    DEFF Research Database (Denmark)

    Christensen, Nicolaj Lyhne; Dahl, Jordi; Carter-Storch, Rasmus

    2017-01-01

    characterized by higher LV mass index (73 ± 17 g/m² vs. 66 ± 16 g/m² , p=0.03), increased right ventricle (70 ± 14 ml/m² vs. 63 ± 12 ml/m², p=0.01) and LV end-diastolic volume index (84 ± 18 ml/m² vs. 77 ± 16 ml/m², p=0.05), and higher brain natriuretic peptide (BNP). No difference in late enhancement was seen......Left atrial (LA) dilatation in asymptomatic severe aortic stenosis (AS) may be an indicator of advanced disease. The aim was to investigate the association between LA volume index (LAVi) and left ventricular (LV) morphology assessed with cardiac magnetic resonance imaging (cMRI), and to assess...... underwent echocardiography, cMRI, exercise test, and patients were followed for the composite endpoint of death, readmission or aortic valve replacement. AVA index was similar (0.45 ± 0.08 cm² /m² vs. 0.45 ± 0.09 cm², p=0.85) in patients with a dilated and normal LA. On cMRI patients with dilated LA were...

  4. Outcomes in cardiac surgery in 500 consecutive Jehovah's Witness patients: 21 year experience.

    Science.gov (United States)

    Vaislic, Claude D; Dalibon, Nicolas; Ponzio, Oliver; Ba, Maguette; Jugan, Eric; Lagneau, Franck; Abbas, Philippe; Olliver, Yves; Gaillard, Didier; Baget, Francois; Sportiche, Michel; Chedid, Antoine; Chaoul, Georges; Maribas, Philippe; Dupuy, Christiane; Robine, Bruno; Kasanin, Nicolas; Michon, Herve; Ruat, Jean-Michel; Habis, Michel; Bouharaoua, Touhami

    2012-09-27

    Refusal of heterogenic blood products can be for religious reasons as in Jehovah's Witnesses or otherwise or as requested by an increasing number of patients. Furthermore blood reserves are under continuous demand with increasing costs. Therefore, transfusion avoidance strategies are desirable. We describe a historic comparison and current results of blood saving protocols in Jehovah's Witnesses patients. Data on 250 Jehovah's Witness patients operated upon between 1991 and 2003 (group A) were reviewed and compared with a second population of 250 patients treated from 2003 to 2012 (group B). In group A, mean age was 51 years of age compared to 68 years in group B. An iterative procedure was performed in 13% of patients in group B. Thirty days mortality was 3% in group A and 1% in group B despite greater operative risk factors, with more redo, and lower ejection fraction in group B. Several factors contributed to the low morbidity-mortality in group B, namely: preoperative erythropoietin to attain a minimal hemoglobin value of 14 g/dl, warm blood cardioplegia, the implementation of the Cornell University protocol and fast track extubation. Cardiac surgery without transfusion in high-risk patients such as Jehovah Witnesses can be carried out with results equivalent to those of low risk patients. Recent advances in surgical techniques and blood conservation protocols are main contributing factors.

  5. Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

    Science.gov (United States)

    Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

    2017-04-01

    Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury

  6. Effects of Massage in Reducing the Pain and Anxiety of the Cardiac Surgery Critically Ill-a Randomized Controlled Trial.

    Science.gov (United States)

    Boitor, Madalina; Martorella, Géraldine; Maheu, Christine; Laizner, Andréa Maria; Gélinas, Céline

    2018-03-30

    To evaluate the effectiveness of hand massage on the pain and anxiety of the cardiac surgery critically ill. A three-arm randomized controlled trial. This study was conducted in a medical-surgical intensive care unit in Canada. Adult patients who underwent elective cardiac surgery, who were able to speak French/English and to self-report symptoms, without a high risk of postoperative complications were eligible. Patients were randomly allocated to standard care plus either two 20-minute hand massages (experimental), two 20-minute hand holdings (active control), or two 20-minute rest periods (passive control/standard care). Pain intensity, pain unpleasantness, anxiety, muscle tension, and vital signs were evaluated before, after, and 30 minutes later for each intervention. From the 83 patients recruited, 60 were randomized (20 massage, 19 hand holding, 21 standard care). After controlling for baseline scores, the massage group reported significantly lower pain intensity, pain unpleasantness, and anxiety for the first data collection set compared with both hand holding and standard care (analysis of covariance, P < 0.02), with an average decrease of two points on a 0-10 scale. No statistically significant differences were noted between hand holding and standard care for any of the symptoms. Similar results were observed for the second data collection set (N = 43). Patients had decreased muscle tension post massage. Vital signs did not differ significantly between groups. Findings suggest that a 20-minute hand massage in addition to routine postoperative pain management can concomitantly reduce pain intensity, pain unpleasantness, and anxiety by two points on average on a 0-10 scale.

  7. Outcome of Cardiac Rehabilitation Following Off-Pump Versus On-Pump Coronary Bypass Surgery

    Directory of Open Access Journals (Sweden)

    Reza Arefizadeh

    2017-05-01

    CONCLUSIONS: Regarding QOL and psychological status, there were no differences in the CR outcome between those who underwent off-pump bypass surgery and those who underwent on-pump surgery; nevertheless, the off-pump technique was superior to the on-pump method on METs improvement following CR.

  8. Adaptive Programming Improves Outcomes in Drug Court: An Experimental Trial.

    Science.gov (United States)

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Benasutti, Kathleen M; Fox, Gloria; Croft, Jason R

    2012-04-01

    Prior studies in Drug Courts reported improved outcomes when participants were matched to schedules of judicial status hearings based on their criminological risk level. The current experiment determined whether incremental efficacy could be gained by periodically adjusting the schedule of status hearings and clinical case-management sessions in response to participants' ensuing performance in the program. The adjustments were made pursuant to a priori criteria specified in an adaptive algorithm. Results confirmed that participants in the full adaptive condition (n = 62) were more than twice as likely as those assigned to baseline-matching only (n = 63) to be drug-abstinent during the first 18 weeks of the program; however, graduation rates and the average time to case resolution were not significantly different. The positive effects of the adaptive program appear to have stemmed from holding noncompliant participants more accountable for meeting their attendance obligations in the program. Directions for future research and practice implications are discussed.

  9. Comparison of cardiac output optimization with an automated closed-loop goal-directed fluid therapy versus non standardized manual fluid administration during elective abdominal surgery: first prospective randomized controlled trial.

    Science.gov (United States)

    Lilot, Marc; Bellon, Amandine; Gueugnon, Marine; Laplace, Marie-Christine; Baffeleuf, Bruno; Hacquard, Pauline; Barthomeuf, Felicie; Parent, Camille; Tran, Thomas; Soubirou, Jean-Luc; Robinson, Philip; Bouvet, Lionel; Vassal, Olivia; Lehot, Jean-Jacques; Piriou, Vincent

    2018-01-27

    An intraoperative automated closed-loop system for goal-directed fluid therapy has been successfully tested in silico, in vivo and in a clinical case-control matching. This trial compared intraoperative cardiac output (CO) in patients managed with this closed-loop system versus usual practice in an academic medical center. The closed-loop system was connected to a CO monitoring system and delivered automated colloid fluid boluses. Moderate to high-risk abdominal surgical patients were randomized either to the closed-loop or the manual group. Intraoperative final CO was the primary endpoint. Secondary endpoints were intraoperative overall mean cardiac index (CI), increase from initial to final CI, intraoperative fluid volume and postoperative outcomes. From January 2014 to November 2015, 46 patients were randomized. There was a lower initial CI (2.06 vs. 2.51 l min -1 m -2 , p = 0.042) in the closed-loop compared to the control group. No difference in final CO and in overall mean intraoperative CI was observed between groups. A significant relative increase from initial to final CI values was observed in the closed-loop but not the control group (+ 28.6%, p = 0.006 vs. + 1.2%, p = 0.843). No difference was found for intraoperative fluid management and postoperative outcomes between groups. There was no significant impact on the primary study endpoint, but this was found in a context of unexpected lower initial CI in the closed-loop group.Trial registry number ID-RCB/EudraCT: 2013-A00770-45. ClinicalTrials.gov Identifier NCT01950845, date of registration: 17 September 2013.

  10. Outcomes and biochemical parameters following cardiac surgery: effects of transfusion of residual blood using centrifugation and multiple-pass hemoconcentration.

    Science.gov (United States)

    McNair, Erick; McKay, William; Qureshi, Abdul Mohamed; Rosin, Mark; Gamble, Jon; Dalshaug, Greg; Mycyk, Taras; Prasad, Kailash

    2013-12-01

    To determine whether or not there was a significant difference between the methods of centrifugation (CF) and multiple-pass hemoconcentration (MPH) of the residual cardiopulmonary-bypass volume in relation to biochemical measurements and patient outcomes. Prospective, randomized, and controlled. Conducted at a western Canadian tertiary care hospital. Consisted of 61 consecutive male and female patients from ages 40 to 80 who were scheduled for cardiac surgery with cardiopulmonary bypass. Either the centrifugation or multiple-pass hemoconcentration method was used to process the residual blood from the cardiopulmonary bypass circuit. The 12-hour postoperative levels of serum hemoglobin were not significantly different in the centrifugation group as compared to the multiple-pass hemoconcentration group. However, the serum levels of total protein and albumin were significantly higher in the multiple-pass hemoconcentration group as compared to the centrifugation group. Additionally, after 12-hours postoperatively, the serum fibrinogen and platelet counts were significantly higher in the multiple-pass hemoconcentration group as compared to those of the centrifugation group. The allogeneic product transfusion index and the chest-tube blood drainage indices were lower in the multiple-pass hemoconcentration group as compared to the centrifugation group. Although the CF method provided a product in a shorter turnaround time, with consistent clearance of heparin, the MPH method trended towards enhanced biochemical and clinical patient outcomes over the 12-hour postoperative period. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Contemporary management and outcomes of acute type A aortic dissection: An analysis of the STS adult cardiac surgery database.

    Science.gov (United States)

    Lee, Teng C; Kon, Zachary; Cheema, Faisal H; Grau-Sepulveda, Maria V; Englum, Brian; Kim, Sunghee; Chaudhuri, Paramita S; Thourani, Vinod H; Ailawadi, Gorav; Hughes, G Chad; Williams, Matthew L; Brennan, J Matthew; Svensson, Lars; Gammie, James S

    2018-01-01

    Management of acute type A aortic dissection (AAAD) is challenging and operative strategies are varied. We used the STS Adult Cardiac Surgery Database (STS ACSD) to describe contemporary surgical strategies and outcomes for AAAD. Between July 2011 and September 2012, 2982 patients with AAAD underwent operations at 640 centers in North America. In this cohort, median age was 60 years old, 66% were male, and 80% had hypertension. The most common arterial cannulation strategies included femoral (36%), axillary (27%), and direct aortic (19%). The median perfusion and cross-clamp times were 181 and 102 min, respectively. The lowest temperature on bypass showed significant variation. Hypothermic circulatory arrest (HCA) was used in 78% of cases. Among those undergoing HCA, brain protection strategies included antegrade cerebral perfusion (31%), retrograde cerebral perfusion (25%), both (4%), and none (40%). Median HCA plus cerebral perfusion time was 40 min. Major complications included prolonged ventilation (53%), reoperation (19%), renal failure (18%), permanent stroke (11%), and paralysis (3%). Operative mortality was 17%. The median intensive care unit and hospital length of stays were 4.7 and 9.0 days, respectively. Among 640 centers, the median number of cases performed during the study period was three. Resuscitation, unresponsive state, cardiogenic shock, inotrope use, age >70, diabetes, and female sex were found to be independent predictors of mortality. These data describe contemporary patient characteristics, operative strategies, and outcomes for AAAD in North America. Mortality and morbidity for AAAD remain high. © 2018 Wiley Periodicals, Inc.

  12. Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

    Science.gov (United States)

    Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

    2015-04-15

    Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

  13. Development and validation of risk models to predict outcomes following in-hospital cardiac arrest attended by a hospital-based resuscitation team.

    Science.gov (United States)

    Harrison, David A; Patel, Krishna; Nixon, Edel; Soar, Jasmeet; Smith, Gary B; Gwinnutt, Carl; Nolan, Jerry P; Rowan, Kathryn M

    2014-08-01

    The National Cardiac Arrest Audit (NCAA) is the UK national clinical audit for in-hospital cardiac arrest. To make fair comparisons among health care providers, clinical indicators require case mix adjustment using a validated risk model. The aim of this study was to develop and validate risk models to predict outcomes following in-hospital cardiac arrest attended by a hospital-based resuscitation team in UK hospitals. Risk models for two outcomes-return of spontaneous circulation (ROSC) for greater than 20min and survival to hospital discharge-were developed and validated using data for in-hospital cardiac arrests between April 2011 and March 2013. For each outcome, a full model was fitted and then simplified by testing for non-linearity, combining categories and stepwise reduction. Finally, interactions between predictors were considered. Models were assessed for discrimination, calibration and accuracy. 22,479 in-hospital cardiac arrests in 143 hospitals were included (14,688 development, 7791 validation). The final risk model for ROSC>20min included: age (non-linear), sex, prior length of stay in hospital, reason for attendance, location of arrest, presenting rhythm, and interactions between presenting rhythm and location of arrest. The model for hospital survival included the same predictors, excluding sex. Both models had acceptable performance across the range of measures, although discrimination for hospital mortality exceeded that for ROSC>20min (c index 0.81 versus 0.72). Validated risk models for ROSC>20min and hospital survival following in-hospital cardiac arrest have been developed. These models will strengthen comparative reporting in NCAA and support local quality improvement. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  14. A 20-year multicentre outcome analysis of salvage mechanical circulatory support for refractory cardiogenic shock after cardiac surgery

    Directory of Open Access Journals (Sweden)

    Maziar Khorsandi

    2016-11-01

    Full Text Available Abstract Background Refractory post-cardiotomy cardiogenic shock (PCCS is a relatively rare phenomenon that can lead to rapid multi-organ dysfunction syndrome and is almost invariably fatal without advanced mechanical circulatory support (AMCS, namely extra-corporeal membrane oxygenation (ECMO or ventricular assist devices (VAD. In this multicentre observational study we retrospectively analyzed the outcomes of salvage venoarterial ECMO (VA ECMO and VAD for refractory PCCS in the 3 adult cardiothoracic surgery centres in Scotland over a 20-year period. Methods The data was obtained through the Edinburgh, Glasgow and Aberdeen cardiac surgery databases. Our inclusion criteria included any adult patient from April 1995 to April 2015 who had received salvage VA ECMO or VAD for PCCS refractory to intra-aortic balloon pump (IABP and maximal inotropic support following adult cardiac surgery. Results A total of 27 patients met the inclusion criteria. Age range was 34–83 years (median 51 years. There was a large male predominance (n = 23, 85 %. Overall 23 patients (85 % received VA ECMO of which 14 (61 % had central ECMO and 9 (39 % had peripheral ECMO. Four patients (15 % were treated with short-term VAD (BiVAD = 1, RVAD = 1 and LVAD = 2. The most common procedure-related complication was major haemorrhage (n = 10. Renal failure requiring renal replacement therapy (n = 7, fatal stroke (n = 5, septic shock (n = 2, and a pseudo-aneurysm at the femoral artery cannulation site (n = 1 were also observed. Overall survival to hospital discharge was 40.7 %. All survivors were NYHA class I-II at 12 months’ follow-up. Conclusion AMCS for refractory PCCS carries a survival benefit and achieves acceptable functional recovery despite a significant complication rate.

  15. Effect of screening for coronary artery disease using CT angiography on mortality and cardiac events in high-risk patients with diabetes: the FACTOR-64 randomized clinical trial.

    Science.gov (United States)

    Muhlestein, Joseph B; Lappé, Donald L; Lima, Joao A C; Rosen, Boaz D; May, Heidi T; Knight, Stacey; Bluemke, David A; Towner, Steven R; Le, Viet; Bair, Tami L; Vavere, Andrea L; Anderson, Jeffrey L

    2014-12-03

    Coronary artery disease (CAD) is a major cause of cardiovascular morbidity and mortality in patients with diabetes mellitus, yet CAD often is asymptomatic prior to myocardial infarction (MI) and coronary death. To assess whether routine screening for CAD by coronary computed tomography angiography (CCTA) in patients with type 1 or type 2 diabetes deemed to be at high cardiac risk followed by CCTA-directed therapy would reduce the risk of death and nonfatal coronary outcomes. The FACTOR-64 study was a randomized clinical trial in which 900 patients with type 1 or type 2 diabetes of at least 3 to 5 years' duration and without symptoms of CAD were recruited from 45 clinics and practices of a single health system (Intermountain Healthcare, Utah), enrolled at a single-site coordinating center, and randomly assigned to CAD screening with CCTA (n = 452) or to standard national guidelines-based optimal diabetes care (n = 448) (targets: glycated hemoglobin level 50 mg/dL [women] or >40 mg/dL [men], triglycerides level <150 mg/dL, systolic blood pressure <120 mm Hg), or aggressive therapy with invasive coronary angiography, was recommended based on CCTA findings. Enrollment occurred between July 2007 and May 2013, and follow-up extended to August 2014. The primary outcome was a composite of all-cause mortality, nonfatal MI, or unstable angina requiring hospitalization; the secondary outcome was ischemic major adverse cardiovascular events (composite of CAD death, nonfatal MI, or unstable angina). At a mean follow-up time of 4.0 (SD, 1.7) years, the primary outcome event rates were not significantly different between the CCTA and the control groups (6.2% [28 events] vs 7.6% [34 events]; hazard ratio, 0.80 [95% CI, 0.49-1.32]; P = .38). The incidence of the composite secondary end point of ischemic major adverse cardiovascular events also did not differ between groups (4.4% [20 events] vs 3.8% [17 events]; hazard ratio, 1.15 [95% CI, 0.60-2.19]; P = .68). Among

  16. International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials

    DEFF Research Database (Denmark)

    Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip

    2017-01-01

    OBJECTIVE: To identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities. METHODS: We conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups t...

  17. Is More Better? Outcome and Dose of a Universal Drug Prevention Effectiveness Trial

    Science.gov (United States)

    Ferrer-Wreder, Laura; Cadely, Hans Saint-Eloi; Domitrovich, Celene E.; Small, Meg L.; Caldwell, Linda L.; Cleveland, Michael J.

    2010-01-01

    Two evidence-based interventions, Life Skills Training and TimeWise, were combined in an effectiveness trial. Participants were predominately African American youth (N = 715; M[subscript age] = 12). The study authors provide an empirical demonstration of the implications of incorporating dosage information in intervention outcome analyses. Study…

  18. Effect of physical activity on frailty and associated negative outcomes: the LIFE randomized trial

    Science.gov (United States)

    Background: Limited evidence suggests that physical activity may prevent frailty and associated negative outcomes in older adults. Definitive data from large, long-term, randomized trials are lacking. Objective: To determine whether a long-term structured moderate-intensity physical activity (PA) p...

  19. The safety of addition of nitrous oxide to general anaesthesia in at-risk patients having major non-cardiac surgery (ENIGMA-II): a randomised, single-blind trial.

    Science.gov (United States)

    Myles, Paul S; Leslie, Kate; Chan, Matthew T V; Forbes, Andrew; Peyton, Philip J; Paech, Michael J; Beattie, W Scott; Sessler, Daniel I; Devereaux, P J; Silbert, Brendan; Schricker, Thomas; Wallace, Sophie

    2014-10-18

    Nitrous oxide is commonly used in general anaesthesia but concerns exist that it might increase perioperative cardiovascular risk. We aimed to gather evidence to establish whether nitrous oxide affects perioperative cardiovascular risk. We did an international, randomised, assessor-blinded trial in patients aged at least 45 years with known or suspected coronary artery disease having major non-cardiac surgery. Patients were randomly assigned via automated telephone service, stratified by site, to receive a general anaesthetic with or without nitrous oxide. Attending anaesthetists were aware of patients' group assignments, but patients and assessors were not. The primary outcome measure was a composite of death and cardiovascular complications (non-fatal myocardial infarction, stroke, pulmonary embolism, or cardiac arrest) within 30 days of surgery. Our modified intention-to-treat population included all patients randomly assigned to groups and undergoing induction of general anaesthesia for surgery. This trial is registered at ClinicalTrials.gov, number NCT00430989. Of 10,102 eligible patients, we enrolled 7112 patients between May 30, 2008, and Sept 28, 2013. 3543 were assigned to receive nitrous oxide and 3569 were assigned not to receive nitrous oxide. 3483 patients receiving nitrous oxide and 3509 not receiving nitrous oxide were assessed for the primary outcome. The primary outcome occurred in 283 (8%) patients receiving nitrous oxide and in 296 (8%) patients not receiving nitrous oxide (relative risk 0·96, 95% CI 0·83–1·12; p=0·64). Surgical site infection occurred in 321 (9%) patients assigned to nitrous oxide, and in 311 (9%) patients in the no-nitrous oxide group (p=0·61), and severe nausea and vomiting occurred in 506 patients (15%) assigned to nitrous oxide and 378 patients (11%) not assigned to nitrous oxide (pnitrous oxide use in major non-cardiac surgery. Nitrous oxide did not increase the risk of death and cardiovascular complications or

  20. Randomized controlled trial of relaxation music to reduce heart rate in patients undergoing cardiac CT

    Energy Technology Data Exchange (ETDEWEB)

    Ng, Ming Yen [University of Toronto, Department of Medical Imaging, Toronto General Hospital, Toronto, ON (Canada); The University of Hong Kong, Queen Mary Hospital, Department of Diagnostic Radiology, Hong Kong (China); Karimzad, Yasser; Menezes, Ravi J.; Wintersperger, Bernd J.; Li, Qin; Forero, Julian; Paul, Narinder S.; Nguyen, Elsie T. [University of Toronto, Department of Medical Imaging, Toronto General Hospital, Toronto, ON (Canada)

    2016-10-15

    To evaluate the heart rate lowering effect of relaxation music in patients undergoing coronary CT angiography (CCTA), pulmonary vein CT (PVCT) and coronary calcium score CT (CCS). Patients were randomised to a control group (i.e. standard of care protocol) or to a relaxation music group (ie. standard of care protocol with music). The groups were compared for heart rate, radiation dose, image quality and dose of IV metoprolol. Both groups completed State-Trait Anxiety Inventory anxiety questionnaires to assess patient experience. One hundred and ninety-seven patients were recruited (61.9 % males); mean age 56y (19-86 y); 127 CCTA, 17 PVCT, 53 CCS. No significant difference in heart rate, radiation dose, image quality, metoprolol dose and anxiety scores. 86 % of patients enjoyed the music. 90 % of patients in the music group expressed a strong preference to have music for future examinations. The patient cohort demonstrated low anxiety levels prior to CT. Relaxation music in CCTA, PVCT and CCS does not reduce heart rate or IV metoprolol use. Patients showed low levels of anxiety indicating that anxiolytics may not have a significant role in lowering heart rate. Music can be used in cardiac CT to improve patient experience. (orig.)

  1. Randomized controlled trial of relaxation music to reduce heart rate in patients undergoing cardiac CT

    International Nuclear Information System (INIS)

    Ng, Ming Yen; Karimzad, Yasser; Menezes, Ravi J.; Wintersperger, Bernd J.; Li, Qin; Forero, Julian; Paul, Narinder S.; Nguyen, Elsie T.

    2016-01-01

    To evaluate the heart rate lowering effect of relaxation music in patients undergoing coronary CT angiography (CCTA), pulmonary vein CT (PVCT) and coronary calcium score CT (CCS). Patients were randomised to a control group (i.e. standard of care protocol) or to a relaxation music group (ie. standard of care protocol with music). The groups were compared for heart rate, radiation dose, image quality and dose of IV metoprolol. Both groups completed State-Trait Anxiety Inventory anxiety questionnaires to assess patient experience. One hundred and ninety-seven patients were recruited (61.9 % males); mean age 56y (19-86 y); 127 CCTA, 17 PVCT, 53 CCS. No significant difference in heart rate, radiation dose, image quality, metoprolol dose and anxiety scores. 86 % of patients enjoyed the music. 90 % of patients in the music group expressed a strong preference to have music for future examinations. The patient cohort demonstrated low anxiety levels prior to CT. Relaxation music in CCTA, PVCT and CCS does not reduce heart rate or IV metoprolol use. Patients showed low levels of anxiety indicating that anxiolytics may not have a significant role in lowering heart rate. Music can be used in cardiac CT to improve patient experience. (orig.)

  2. Effect of donor body mass index on the outcome of donation after cardiac death kidneys: how big is too big?

    Science.gov (United States)

    Jin, L X; Pitt, S C; Doyle, M B; Klein, C; Shenoy, S; Lowell, J A; Chapman, W C; Wellen, J R

    2014-01-01

    Morbid obesity (MO) has become an epidemic in the United Sates and is associated with adverse effects on health. The purpose of this study was to examine the effects of MO on the short-term outcomes of kidneys transplanted from donation after cardiac death (DCD) donors. Using a prospectively collected database, we reviewed 467 kidney transplantations performed at a single center between January 2008 and June 2011 to identify 67 recipients who received transplants from 40 DCD donors. The outcomes of 14 MO DCD donor kidneys were compared with 53 non-MO DCD grafts. MO was defined as a body mass index ≥ 35. Mean patient follow-up was 16 months. The MO and non-MO DCD donor groups were similar with respect to donor and recipient age, gender, race, cause of death and renal disease, time from withdrawal of life support to organ perfusion, mean human leukocyte antigen (HLA) mismatch, and overall recipient survival. Organs from MO DCD donors also had comparable rates of delayed graft function (21.4% vs 20.0%; P = not significant [NS]). At 1 year post-transplantation, a small but statistically insignificant difference was observed in the graft survival rates of MO and non-MO donors (87% vs. 96%; P = NS). One MO kidney had primary nonfunction. These data demonstrate that kidneys procured from MO DCD donors have equivalent short-term outcomes compared with non-MO grafts and should continue to be used. Further investigation is needed to examine the effect of MO on long-term renal allograft survival. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. The Impact of Hospital’s Cardiac Specialization on Outcomes after Coronary Artery Bypass Graft Surgery: Analysis of Medicare Claims Data

    Science.gov (United States)

    Girotra, Saket; Lu, Xin; Popescu, Ioana; Vaughan-Sarrazin, Mary; Horwitz, Phillip A.; Cram, Peter

    2011-01-01

    Background Hospital volume has been widely embraced as a proxy measure for hospital quality; little attention has been focused on an alternative quality measure-hospital specialization. Even though specialization occurs on a continuum, previous studies have only focused on a small number of highly specialized hospitals (single-specialty hospitals). Studies on the broad relationship between hospital specialization and outcomes after coronary artery bypass grafting (CABG) are limited. Methods and Results We conducted a retrospective cohort study of 705,084 Medicare patients (1130 hospitals) who underwent CABG during 2001-2005. We stratified hospitals into quintiles based on their degree of cardiac specialization (proportion of a hospital’s Medicare discharges classified as Major Diagnostic Category 5 – cardiovascular diseases). We compared patient and hospital characteristics and outcomes across quintiles of cardiac specialization. Patient characteristics were generally similar across quintiles, but mean annual CABG volume increased progressively from quintile 1 (least-specialized) to quintile 5 (most-specialized). Unadjusted 30-day mortality was similar at hospitals in quintiles 1-4 (4.8%), except quintile 5 where mortality was lower (4.3%). A strong inverse association was seen between hospital cardiac specialization and 30-day mortality after adjustment for patient characteristics (P trend=0.001). However, this was no longer significant after additional adjustment for CABG volume (P trend=0.65). Results were similar for other mortality outcomes and length of stay. Conclusions After accounting for patient characteristics and CABG volume, greater cardiac specialization was not associated with clinically significant improvement in patient outcomes. This study calls into question the benefit of cardiac specialization for the vast majority of CABG-performing U.S. hospitals. PMID:20923993

  4. Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life: Rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT)

    NARCIS (Netherlands)

    van den Brink, Rob H. S.; van Melle, Joost P.; Honig, Adriaan; Schene, Aart H.; Crijns, Harry J. G. M.; Lambert, Frank P. G.; Ormel, Johan

    2002-01-01

    Background Patients with a depressive disorder after myocardial infarction (MI) have a significantly increased risk of major cardiac events. The Myocardial INfarction and Depression-Intervention Trial (MIND-IT) investigates whether antidepressive treatment can improve the cardiac prognosis for these

  5. Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life : Rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT)

    NARCIS (Netherlands)

    van den Brink, Rob H. S.; van Melle, Joost P.; Honig, A; Schene, AH; Crijns, Harry J. G. M.; Lambert, FPG; Ormel, Johan

    Background Patients with a depressive disorder after myocardial infarction (MI) have a significantly increased risk of major cardiac events. The Myocardial INfarction and Depression-Intervention Trial (MIND-IT) investigates whether antidepressive treatment can improve the cardiac prognosis for these

  6. Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

    Science.gov (United States)

    Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C

    2016-01-01

    The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  7. Poor nutritional status on admission predicts poor outcomes after stroke: observational data from the FOOD trial.

    Science.gov (United States)

    2003-06-01

    Previous studies suggest that undernourished patients with acute stroke do badly. The data, however, are not robust. We aimed to reliably assess the importance of baseline nutritional status as an independent predictor of long-term outcome after stroke in a large prospective cohort enrolled in the Feed Or Ordinary Diet (FOOD) trial, a multicenter randomized trial evaluating various feeding policies. Patients admitted to hospital with a recent stroke were enrolled in the FOOD trial. Data on nutritional status and other clinical predictors of outcome were collected at trial entry. At 6 months, the coordinating center collected data on survival and functional status (modified Rankin Scale). Outcome assessment was done by researchers blinded to baseline assessments and treatment allocation. Between November 1996 and November 2001, 3012 patients were enrolled, and 2955 (98%) were followed up. Of the 275 undernourished patients, 102 (37%) were dead by final follow-up compared with only 445 (20%) of 2194 patients of normal nutritional status (odds ratio [OR], 2.32; 95% CI, 1.78 to 3.02). After adjustment for age, prestroke functional state, and stroke severity, this relationship, although weakened, still held (OR, 1.82; 95% CI, 1.34 to 2.47). Undernourished patients were more likely to develop pneumonia, other infections, and gastrointestinal bleeding during their hospital admission than other patients. These data provide reliable evidence that nutritional status early after stroke is independently associated with long-term outcome. It supports the rationale for the FOOD trial, which continues to recruit and aims to estimate the effect of different feeding regimes on outcome after stroke and thus determine whether the association observed in this study is likely to be causal.

  8. Missing continuous outcomes under covariate dependent missingness in cluster randomised trials.

    Science.gov (United States)

    Hossain, Anower; Diaz-Ordaz, Karla; Bartlett, Jonathan W

    2017-06-01

    Attrition is a common occurrence in cluster randomised trials which leads to missing outcome data. Two approaches for analysing such trials are cluster-level analysis and individual-level analysis. This paper compares the performance of unadjusted cluster-level analysis, baseline covariate adjusted cluster-level analysis and linear mixed model analysis, under baseline covariate dependent missingness in continuous outcomes, in terms of bias, average estimated standard error and coverage probability. The methods of complete records analysis and multiple imputation are used to handle the missing outcome data. We considered four scenarios, with the missingness mechanism and baseline covariate effect on outcome either the same or different between intervention groups. We show that both unadjusted cluster-level analysis and baseline covariate adjusted cluster-level analysis give unbiased estimates of the intervention effect only if both intervention groups have the same missingness mechanisms and there is no interaction between baseline covariate and intervention group. Linear mixed model and multiple imputation give unbiased estimates under all four considered scenarios, provided that an interaction of intervention and baseline covariate is included in the model when appropriate. Cluster mean imputation has been proposed as a valid approach for handling missing outcomes in cluster randomised trials. We show that cluster mean imputation only gives unbiased estimates when missingness mechanism is the same between the intervention groups and there is no interaction between baseline covariate and intervention group. Multiple imputation shows overcoverage for small number of clusters in each intervention group.

  9. Pregnancy outcome of threatened abortion with demonstrable fetal cardiac activity: a cohort study.

    Science.gov (United States)

    Tongsong, T; Srisomboon, J; Wanapirak, C; Sirichotiyakul, S; Pongsatha, S; Polsrisuthikul, T

    1995-08-01

    Pregnancy with visible fetal heart beat complicated by first trimester threatened abortion had significant increased risk of subsequent spontaneous abortion compared with normal pregnancy. To compare pregnancy outcomes in cases complicated by first trimester threatened abortion with those that were not. Prospective cohort study of 255 cases of first trimester threatened abortions but with visible heart beat and 265 other normal pregnancies. Spontaneous abortion rates of 5.5% (with relative abortal risk of 2.91) was found for study group, compared to 1.88% for controls (p abortion rate than those without.

  10. A randomized trial of early versus delayed mediastinal drain removal after cardiac surgery using silastic and conventional tubes

    Science.gov (United States)

    Moss, Emmanuel; Miller, Corey S.; Jensen, Henrik; Basmadjian, Arsène; Bouchard, Denis; Carrier, Michel; Perrault, Louis P.; Cartier, Raymond; Pellerin, Michel; Demers, Philippe

    2013-01-01

    OBJECTIVES Mediastinal drainage following cardiac surgery with traditional large-bore plastic tubes can be painful and cumbersome. This study was designed to determine whether prolonged drainage (5 days) with a silastic tube decreased the incidence of significant pericardial effusion and tamponade following aortic or valvular surgery. METHODS One hundred and fifty patients undergoing valvular or aortic surgery in a tertiary cardiac surgery institution were randomized to receive a conventional mediastinal tube plus a silastic Blake drain (n = 75), or two conventional tubes (n = 75). Conventional drains were removed on postoperative day (POD) 1, while Blake drains were removed on POD 5. The primary end-point was the combined incidence of significant pericardial effusion (≥15 mm) or tamponade through POD 5. Secondary end-points included total mediastinal drainage, postoperative atrial fibrillation (AF) and pain. RESULTS Analysis was performed for 67 patients in the Blake group and 73 in the conventional group. There was no difference between the two groups in the combined end-point of significant effusion or tamponade (7.4 vs 8.3%, P = 0.74), or in the incidence of AF (47 vs 46%, P = 0.89). Mean 24-h drainage was greater in the Blake group than in the conventional group (749 ± 444 ml vs 645 ± 618 ml, P tubes is safe and does not increase postoperative pain. There was no difference between the Blake and conventional drains with regard to significant pericardial effusion or tamponade in this cohort; however, this conclusion is limited by the low overall incidence of the primary outcome in this cohort. PMID:23575759

  11. The verdict on jury trials for juveniles: the effects of defendant's age on trial outcomes.

    Science.gov (United States)

    Warling, Diane; Peterson-Badali, Michele

    2003-01-01

    With the progression to more adult-like policies and procedures for youth in the justice system, the right to a jury trial has been extended to young offenders. These youth would not be tried by a jury of their peers, however, but by a jury of adults. The concern is that adult jurors may hold negative attitudes about youth that might influence their decision making in a case involving a young defendant. Two studies examined whether and under what conditions defendant's age affects jurors' decisions about the guilt and sentencing of an accused. In study 1, data were gathered from two samples of jury eligible adults: one university sample and one public sample. Mock jurors read written transcripts of a trial involving a defendant who was presented as either 13, 17, or 25 years of age. Results indicated that the defendant's age had no effect on mock jurors' verdict or their ratings of defendant guilt. However, younger defendants were granted shorter sentences than the adult defendants. In study 2, mock jurors read the same trial presented in study 1 but were asked to deliberate about the case and render group verdicts. These group verdicts did not differ significantly by defendant's age. Age-related themes that emerged from group deliberations were identified, and results indicated that age tended to be used as a mitigating factor in favor of youth rather than against them. These findings are discussed in terms of their implications for youth justice policy and practice. Copyright 2003 John Wiley & Sons, Ltd.

  12. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials

    DEFF Research Database (Denmark)

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E

    2016-01-01

    in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety......OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety...... that patients consider relevant so that they will be able to make informed decisions. CONCLUSION: The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach....

  13. Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial--design and methods.

    Science.gov (United States)

    Wei, John; Nygaard, Ingrid; Richter, Holly; Brown, Morton; Barber, Matthew; Xiao Xu; Kenton, Kimberly; Nager, Charles; Schaffer, Joseph; Visco, Anthony; Weber, Anne

    2009-04-01

    The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible

  14. Association of prehospital advanced airway management with neurologic outcome and survival in patients with out-of-hospital cardiac arrest.

    Science.gov (United States)

    Hasegawa, Kohei; Hiraide, Atsushi; Chang, Yuchiao; Brown, David F M

    2013-01-16

    It is unclear whether advanced airway management such as endotracheal intubation or use of supraglottic airway devices in the prehospital setting improves outcomes following out-of-hospital cardiac arrest (OHCA) compared with conventional bag-valve-mask ventilation. To test the hypothesis that prehospital advanced airway management is associated with favorable outcome after adult OHCA. Prospective, nationwide, population-based study (All-Japan Utstein Registry) involving 649,654 consecutive adult patients in Japan who had an OHCA and in whom resuscitation was attempted by emergency responders with subsequent transport to medical institutions from January 2005 through December 2010. Favorable neurological outcome 1 month after an OHCA, defined as cerebral performance category 1 or 2. Of the eligible 649,359 patients with OHCA, 367,837 (57%) underwent bag-valve-mask ventilation and 281,522 (43%) advanced airway management, including 41,972 (6%) with endotracheal intubation and 239,550 (37%) with use of supraglottic airways. In the full cohort, the advanced airway group incurred a lower rate of favorable neurological outcome compared with the bag-valve-mask group (1.1% vs 2.9%; odds ratio [OR], 0.38; 95% CI, 0.36-0.39). In multivariable logistic regression, advanced airway management had an OR for favorable neurological outcome of 0.38 (95% CI, 0.37-0.40) after adjusting for age, sex, etiology of arrest, first documented rhythm, witnessed status, type of bystander cardiopulmonary resuscitation, use of public access automated external defibrillator, epinephrine administration, and time intervals. Similarly, the odds of neurologically favorable survival were significantly lower both for endotracheal intubation (adjusted OR, 0.41; 95% CI, 0.37-0.45) and for supraglottic airways (adjusted OR, 0.38; 95% CI, 0.36-0.40). In a propensity score-matched cohort (357,228 patients), the adjusted odds of neurologically favorable survival were significantly lower both for

  15. The HEART mobile phone trial: The partial mediating effects of self-efficacy on physical activity among cardiac patients

    Directory of Open Access Journals (Sweden)

    Ralph eMaddison

    2014-05-01

    Full Text Available Background: The ubiquitous use of mobile phones provides an ideal opportunity to deliver interventions to increase physical activity levels. Understanding potential mediators of such interventions is needed to increase their effectiveness. A recent randomized controlled trial of a mobile phone and Internet (mHealth intervention was conducted in New Zealand to determine the effectiveness on exercise capacity and physical activity levels in addition to current cardiac rehabilitation (CR services for people (n=171 with ischaemic heart disease (IHD. Significant intervention effect was observed for self-reported leisure time physical activity and walking, but not peak oxygen uptake (PVO2 at 24 weeks. There was also significant improvement in self-efficacy.Objective: To evaluate the mediating effect of self-efficacy on physical activity levels in an mHealth delivered exercise CR programme. Methods: Treatment evaluations were performed on the principle of intention to treat (ITT. Adjusted regression analyses were conducted to evaluate the main treatment effect on leisure time physical activity and walking at 24 weeks, with and without change in self-efficacy as the mediator of interest. Results: Change in self-efficacy at 24 weeks significantly mediated the treatment effect on leisure time physical activity by 13%, but only partially mediated the effect on walking by 4% at 24 weeks. Conclusion: An mHealth intervention involving text messaging and Internet support had a positive treatment effect on leisure time physical activity and walking at 24 weeks, and this effect was likely mediated through changes in self-efficacy. Future trials should examine other potential mediators related to this type of intervention.

  16. Association between funding, risk of bias, and outcome of randomised controlled trials in oral and maxillofacial surgery

    NARCIS (Netherlands)

    Oomens, M.A.E.M.; Lazzari, S.; Heymans, M.W.; Forouzanfar, T.

    2016-01-01

    The influence of funding on the main outcome of a random control trial (RCT) is important, as it could potentially lead to bias towards industry, and results that are too optimistic. We investigated the association between funding, the published outcome, and the risk of bias in trials in oral and

  17. Milrinone for cardiac dysfunction in critically ill adult patients

    DEFF Research Database (Denmark)

    Koster, Geert; Bekema, Hanneke J; Wetterslev, Jørn

    2016-01-01

    INTRODUCTION: Milrinone is an inotrope widely used for treatment of cardiac failure. Because previous meta-analyses had methodological flaws, we decided to conduct a systematic review of the effect of milrinone in critically ill adult patients with cardiac dysfunction. METHODS: This systematic...... trials were at high risk of bias, and none reported the primary composite outcome SAE. Fourteen trials with 1611 randomised patients reported mortality data at maximum follow-up (RR 0.96; 95% confidence interval 0.76-1.21). Milrinone did not significantly affect other patient-centred outcomes. All...... analyses displayed statistical and/or clinical heterogeneity of patients, interventions, comparators, outcomes, and/or settings and all featured missing data. DISCUSSION: The current evidence on the use of milrinone in critically ill adult patients with cardiac dysfunction suffers from considerable risks...

  18. Shared medical appointments: improving access, outcomes, and satisfaction for patients with chronic cardiac diseases.

    Science.gov (United States)

    Bartley, Kelly Bauer; Haney, Rebecca

    2010-01-01

    Improving access to care, health outcomes, and patient satisfaction are primary objectives for healthcare practices. This article outlines benefits, concerns, and possible challenges of shared medical appointments (SMAs) for patients and providers. The SMA model was designed to support providers' demanding schedules by allowing patients with the same chronic condition to be seen in a group setting. By concentrating on patient education and disease management, interactive meetings provide an opportunity for patients to share both successes and struggles with others experiencing similar challenges. Studies demonstrated that SMAs improved patient access, enhanced outcomes, and promoted patient satisfaction. This article describes the potential benefits of SMAs for patients with chronic heart disease, which consumes a large number of healthcare dollars related to hospital admissions, acute exacerbations, and symptom management. Education for self-management of chronic disease can become repetitive and time consuming. The SMA model introduces a fresh and unique style of healthcare visits, allowing providers to devote more time and attention to patients and improve productivity. The SMA model provides an outstanding method for nurse practitioners to demonstrate their role as a primary care provider, by leading patients in group discussions and evaluating their current health status. Patient selection, preparation, and facilitation of an SMA are discussed to demonstrate the complementary nature of an SMA approach in a healthcare practice.

  19. Vasopressin, steroids, and epinephrine and neurologically favorable survival after in-hospital cardiac arrest: a randomized clinical trial.

    Science.gov (United States)

    Mentzelopoulos, Spyros D; Malachias, Sotirios; Chamos, Christos; Konstantopoulos, Demetrios; Ntaidou, Theodora; Papastylianou, Androula; Kolliantzaki, Iosifinia; Theodoridi, Maria; Ischaki, Helen; Makris, Dimosthemis; Zakynthinos, Epaminondas; Zintzaras, Elias; Sourlas, Sotirios; Aloizos, Stavros; Zakynthinos, Spyros G

    2013-07-17

    Among patients with cardiac arrest, preliminary data have shown improved return of spontaneous circulation and survival to hospital discharge with the vasopressin-steroids-epinephrine (VSE) combination. To determine whether combined vasopressin-epinephrine during cardiopulmonary resuscitation (CPR) and corticosteroid supplementation during and after CPR improve survival to hospital discharge with a Cerebral Performance Category (CPC) score of 1 or 2 in vasopressor-requiring, in-hospital cardiac arrest. Randomized, double-blind, placebo-controlled, parallel-group trial performed from September 1, 2008, to October 1, 2010, in 3 Greek tertiary care centers (2400 beds) with 268 consecutive patients with cardiac arrest requiring epinephrine according to resuscitation guidelines (from 364 patients assessed for eligibility). Patients received either vasopressin (20 IU/CPR cycle) plus epinephrine (1 mg/CPR cycle; cycle duration approximately 3 minutes) (VSE group, n = 130) or saline placebo plus epinephrine (1 mg/CPR cycle; cycle duration approximately 3 minutes) (control group, n = 138) for the first 5 CPR cycles after randomization, followed by additional epinephrine if needed. During the first CPR cycle after randomization, patients in the VSE group received methylprednisolone (40 mg) and patients in the control group received saline placebo. Shock after resuscitation was treated with stress-dose hydrocortisone (300 mg daily for 7 days maximum and gradual taper) (VSE group, n = 76) or saline placebo (control group, n = 73). Return of spontaneous circulation (ROSC) for 20 minutes or longer and survival to hospital discharge with a CPC score of 1 or 2. Follow-up was completed in all resuscitated patients. Patients in the VSE group vs patients in the control group had higher probability for ROSC of 20 minutes or longer (109/130 [83.9%] vs 91/138 [65.9%]; odds ratio [OR], 2.98; 95% CI, 1.39-6.40; P = .005) and survival to hospital discharge with CPC

  20. Prediction of cardiac sympathetic nerve activity and cardiac functional outcome after treatment in patients with dilated cardiomyopathy. Examination using dobutamine gated blood pool scintigraphy

    Energy Technology Data Exchange (ETDEWEB)

    Kasama, Shu; Toyama, Takuji; Iwasaki, Tsutomu; Suzuki, Tadashi [Gunma Univ., Maebashi (Japan). School of Medicine; Hoshizaki, Hiroshi; Oshima, Shigeru; Taniguchi, Koichi; Nagai, Ryozo

    2000-07-01

    This study evaluated whether dobutamine gated blood pool scintigraphy can predict improvement of cardiac sympathetic nerve activity and cardiac function. Sixteen patients (10 men and 6 women, mean age 59{+-}13 years) with dilated cardiomyopathy underwent dobutamine gated blood pool scintigraphy to measure left ventricular ejection fraction (LVEF) using tracer at 0, 5, 10 and 15 {mu}g/kg/min before treatment. Patients were divided into good responders (LVEF increase {>=}15%) 8 patients (GR Group) and poor responders (LVEF increase <15%) 8 patients (PR Group) after treatment with {beta}-blocker or amiodarone with a background treatment of digitalis, diuretics and angiotensin converting enzyme inhibitor. I-123 metaiodobenzylguanidine (MIBG) imaging to evaluate cardiac sympathetic nerve activity and echocardiography were performed before and at one year after treatment. MIBG imaging was obtained 4 hours after tracer injection, and the heart/mediastinum count ratio (H/M ratio) calculated from the anterior planar image and the total defect score (TDS) from the single photon emission computed tomography image. LVEF and left ventricular endo-diastolic dimension (LVDd) were measured by echocardiography and New York Heart Association (NYHA) functional class was evaluated. The GR Group showed TDS decreased from 28{+-}6 to 17{+-}12 (p<0.05), H/M ratio increased from 1.79{+-}0.26 to 2.07{+-}0.32 (p<0.05), LVEF increased from 29{+-}8% to 48{+-}10% (p<0.01), and LVDd decreased from 65{+-}4 mm to 58{+-}5 mm (p<0.05). In contrast, the PR group showed no significant changes in TDS. H/M ratio, LVEF and LVDd. NYHA functional class improved in both groups. The improvement was better in the GR Group than in the PR group. Dobutamine gated blood pool scintigraphy is useful to predict the improvement of the cardiac sympathetic nerve activity and cardiac function, and symptoms after treatment in patients with dilated cardiomyopathy. (author)

  1. Simulation exercise to improve retention of cardiopulmonary resuscitation priorities for in-hospital cardiac arrests: A randomized controlled trial.

    Science.gov (United States)

    Sullivan, Nancy J; Duval-Arnould, Jordan; Twilley, Marida; Smith, Sarah P; Aksamit, Deborah; Boone-Guercio, Pam; Jeffries, Pamela R; Hunt, Elizabeth A

    2015-01-01

    Traditional American Heart Association (AHA) cardiopulmonary resuscitation (CPR) curriculum focuses on teams of two performing quality chest compressions with rescuers on their knees but does not include training specific to In-Hospital Cardiac Arrests (IHCA), i.e. patient in hospital bed with large resuscitation teams and sophisticated technology available. A randomized controlled trial was conducted with the primary goal of evaluating the effectiveness and ideal frequency of in-situ training on time elapsed from call for help to; (1) initiation of chest compressions and (2) successful defibrillation in IHCA. Non-intensive care unit nurses were randomized into four groups: standard AHA training (C) and three groups that participated in 15 min in-situ IHCA training sessions every two (2M), three (3M) or six months (6M). Curriculum included specific choreography for teams to achieve immediate chest compressions, high chest compression fractions and rapid defibrillation while incorporating use of a backboard, stepstool. More frequent training was associated with decreased median (IQR) seconds to: starting compressions: [C: 33(25-40) vs. 6M: 21(15-26) vs. 3M: 14(10-20) vs. 2M: 13(9-20); p training sessions: [C:5%(1/18) vs. 6M: 23%(4/17) vs. 3M: 56%(9/16) vs. 2M: 73%(11/15); p training sessions conducted every 3 months are effective in improving timely initiation of chest compressions and defibrillation in IHCA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. Development and validation of risk models to predict outcomes following in-hospital cardiac arrest attended by a hospital-based resuscitation team☆

    Science.gov (United States)

    Harrison, David A.; Patel, Krishna; Nixon, Edel; Soar, Jasmeet; Smith, Gary B.; Gwinnutt, Carl; Nolan, Jerry P.; Rowan, Kathryn M.

    2014-01-01

    Aim The National Cardiac Arrest Audit (NCAA) is the UK national clinical audit for in-hospital cardiac arrest. To make fair comparisons among health care providers, clinical indicators require case mix adjustment using a validated risk model. The aim of this study was to develop and validate risk models to predict outcomes following in-hospital cardiac arrest attended by a hospital-based resuscitation team in UK hospitals. Methods Risk models for two outcomes—return of spontaneous circulation (ROSC) for greater than 20 min and survival to hospital discharge—were developed and validated using data for in-hospital cardiac arrests between April 2011 and March 2013. For each outcome, a full model was fitted and then simplified by testing for non-linearity, combining categories and stepwise reduction. Finally, interactions between predictors were considered. Models were assessed for discrimination, calibration and accuracy. Results 22,479 in-hospital cardiac arrests in 143 hospitals were included (14,688 development, 7791 validation). The final risk model for ROSC > 20 min included: age (non-linear), sex, prior length of stay in hospital, reason for attendance, location of arrest, presenting rhythm, and interactions between presenting rhythm and location of arrest. The model for hospital survival included the same predictors, excluding sex. Both models had acceptable performance across the range of measures, although discrimination for hospital mortality exceeded that for ROSC > 20 min (c index 0.81 versus 0.72). Conclusions Validated risk models for ROSC > 20 min and hospital survival following in-hospital cardiac arrest have been developed. These models will strengthen comparative reporting in NCAA and support local quality improvement. PMID:24830872

  3. Nitrates for the prevention of cardiac morbidity and mortality in patients undergoing non-cardiac surgery.

    Science.gov (United States)

    Zhao, Na; Xu, Jin; Singh, Balwinder; Yu, Xuerong; Wu, Taixiang; Huang, Yuguang

    2016-08-04

    Cardiac complications are not uncommon in patients undergoing non-cardiac surgery, especially in patients with coronary artery disease (CAD) or at high risk of CAD. Perioperative cardiac complications can lead to mortality and morbidity, as well as higher costs for patient care. Nitrates, which are among the most commonly used cardiovascular drugs, perform the function of decreasing cardiac preload while improving cardiac blood perfusion. Sometimes, nitrates are administered to patients undergoing non-cardiac surgery to reduce the incidence of cardiac complications, especially for patients with CAD. However, their effects on patients' relevant outcomes remain controversial. • To assess effects of nitrates as compared with other interventions or placebo in reducing cardiac risk (such as death caused by cardiac factors, angina pectoris, acute myocardial infarction, acute heart failure and cardiac arrhythmia) in patients undergoing non-cardiac surgery.• To identify the influence of different routes and dosages of nitrates on patient outcomes. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Chinese BioMedical Database until June 2014. We also searched relevant conference abstracts of important anaesthesiology or cardiology scientific meetings, the database of ongoing trials and Google Scholar.We reran the search in January 2016. We added three potential new studies of interest to the list of 'Studies awaiting classification' and will incorporate them into our formal review findings for the review update. We included randomized controlled trials (RCTs) comparing nitrates versus no treatment, placebo or other pharmacological interventions in participants (15 years of age and older) undergoing non-cardiac surgery under any type of anaesthesia. We used standard methodological procedures as expected by Cochrane. Two review authors selected trials, extracted data from included studies and assessed risk of bias. We

  4. Effect of Rosa damascene aromatherapy on sleep quality in cardiac patients: a randomized controlled trial.

    Science.gov (United States)

    Hajibagheri, Ali; Babaii, Atye; Adib-Hajbaghery, Mohsen

    2014-08-01

    Sleep disorders are common among patients hospitalized in coronary care unit (CCU). This study aimed to investigate the effect of Rosa damascene aromatherapy on sleep quality of patients hospitalized in CCU. In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received routine care and Rosa damascene aromatherapy for three subsequent nights. In the both groups the sleep quality was assessed using the Pittsburgh Sleep Quality Index. After the study, the mean scores of five domains of Pittsburg Sleep Quality Index as well as the mean of total score of the index in the experimental group were significantly lower than the control group. Rosa damascene aromatherapy can significantly improve the sleep quality of patients hospitalized in CCUs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Survival in patients without acute ST elevation after cardiac arrest and association with early coronary angiography

    DEFF Research Database (Denmark)

    Dankiewicz, J; Nielsen, N; Annborn, M

    2015-01-01

    PURPOSE: To investigate whether early coronary angiography (CAG) after out-of-hospital cardiac arrest of a presumed cardiac cause is associated with improved outcomes in patients without acute ST elevation. METHODS: The target temperature management after out-of-hospital cardiac arrest (TTM) trial...... showed no difference in all-cause mortality or neurological outcome between an intervention of 33 and 36 °C. In this post hoc analysis, 544 patients where the admission electrocardiogram did not show acute ST elevation were included. Early CAG was defined as being performed on admission or within...... early CAG was not significantly associated with survival. CONCLUSIONS: In this post hoc observational study of a large randomized trial, early coronary angiography for patients without acute ST elevation after out-of-hospital cardiac arrest of a presumed cardiac cause was not associated with improved...

  6. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    Energy Technology Data Exchange (ETDEWEB)

    Fairchild, Alysa, E-mail: alysa.fairchild@albertahealthservices.ca [Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta (Canada); Straube, William [Advanced Technology Consortium, Imaged-Guided Therapy QA Center, St. Louis, Missouri (United States); Laurie, Fran [Quality Assurance Review Center, Lincoln, Rhode Island (United States); Followill, David [Radiological Physics Center, University of Texas MD Anderson Cancer Centre, Houston, Texas (United States)

    2013-10-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.

  7. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    International Nuclear Information System (INIS)

    Fairchild, Alysa; Straube, William; Laurie, Fran; Followill, David

    2013-01-01

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question

  8. Cardiac Rehabilitation for Patients With Coronary Artery Disease: A Practical Guide to Enhance Patient Outcomes Through Continuity of Care

    Directory of Open Access Journals (Sweden)

    Catherine Giuliano

    2017-06-01

    Full Text Available Coronary artery disease (CAD is a leading cause of disease burden worldwide. Referral to cardiac rehabilitation (CR is a class I recommendation for all patients with CAD based on findings that participation can reduce cardiovascular and all-cause mortality, as well as improve functional capacity and quality of life. However, programme uptake remains low, systematic progression through the traditional CR phases is often lacking, and communication between health care providers is frequently suboptimal, resulting in fragmented care. Only 30% to 50% of eligible patients are typically referred to outpatient CR and fewer still complete the programme. In contemporary models of CR, patients are no longer treated by a single practitioner, but rather by an array of health professionals, across multiples specialities and health care settings. The risk of fragmented care in CR may be great, and a concerted approach is required to achieve continuity and optimise patient outcomes. ‘Continuity of care’ has been described as the delivery of services in a coherent, logical, and timely fashion and which entails 3 specific domains: informational, management, and relational continuity. This is examined in the context of CR.

  9. Intraspinal neural stem cell transplantation in amyotrophic lateral sclerosis: phase 1 trial outcomes.

    Science.gov (United States)

    Feldman, Eva L; Boulis, Nicholas M; Hur, Junguk; Johe, Karl; Rutkove, Seward B; Federici, Thais; Polak, Meraida; Bordeau, Jane; Sakowski, Stacey A; Glass, Jonathan D

    2014-03-01

    The US Food and Drug Administration-approved trial, "A Phase 1, Open-Label, First-in-Human, Feasibility and Safety Study of Human Spinal Cord-Derived Neural Stem Cell Transplantation for the Treatment of Amyotrophic Lateral Sclerosis, Protocol Number: NS2008-1," is complete. Our overall objective was to assess the safety and feasibility of stem cell transplantation into lumbar and/or cervical spinal cord regions in amyotrophic lateral sclerosis (ALS) subjects. Preliminary results have been reported on the initial trial cohort of 12 ALS subjects. Here, we describe the safety and functional outcome monitoring results for the final trial cohort, consisting of 6 ALS subjects receiving 5 unilateral cervical intraspinal neural stem cell injections. Three of these subjects previously received 10 total bilateral lumbar injections as part of the earlier trial cohort. All injections utilized a novel spinal-mounted stabilization and injection device to deliver 100,000 neural stem cells per injection, for a dosing range up to 1.5 million cells. Subject assessments included detailed pre- and postsurgical neurological outcome measures. The cervical injection procedure was well tolerated and disease progression did not accelerate in any subject, verifying the safety and feasibility of cervical and dual-targeting approaches. Analyses on outcome data revealed preliminary insight into potential windows of stem cell biological activity and identified clinical assessment measures that closely correlate with ALS Functional Rating Scale-Revised scores, a standard assessment for ALS clinical trials. This is the first report of cervical and dual-targeted intraspinal transplantation of neural stem cells in ALS subjects. This approach is feasible and well-tolerated, supporting future trial phases examining therapeutic dosing and efficacy. © 2014 Child Neurology Society/American Neurological Association.

  10. A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

    Science.gov (United States)

    Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

    2014-09-01

    To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

  11. Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study.

    Science.gov (United States)

    Kolamunnage-Dona, Ruwanthi; Powell, Colin; Williamson, Paula Ruth

    2016-04-28

    Clinical trials with longitudinally measured outcomes are often plagued by missing data due to patients withdrawing or dropping out from the trial before completing the measurement schedule. The reasons for dropout are sometimes clearly known and recorded during the trial, but in many instances these reasons are unknown or unclear. Often such reasons for dropout are non-ignorable. However, the standard methods for analysing longitudinal outcome data assume that missingness is non-informative and ignore the reasons for dropout, which could result in a biased comparison between the treatment groups. In this article, as a post hoc analysis, we explore the impact of informative dropout due to competing reasons on the evaluation of treatment effect in the MAGNETIC trial, the largest randomised placebo-controlled study to date comparing the addition of nebulised magnesium sulphate to standard treatment in acute severe asthma in children. We jointly model longitudinal outcome and informative dropout process to incorporate the information regarding the reasons for dropout by treatment group. The effect of nebulised magnesium sulphate compared with standard treatment is evaluated more accurately using a joint longitudinal-competing risk model by taking account of such complexities. The corresponding estimates indicate that the rate of dropout due to good prognosis is about twice as high in the magnesium group compared with standard treatment. We emphasise the importance of identifying reasons for dropout and undertaking an appropriate statistical analysis accounting for such dropout. The joint modelling approach accounting for competing reasons for dropout is proposed as a general approach for evaluating the sensitivity of conclusions to assumptions regarding missing data in clinical trials with longitudinal outcomes. EudraCT number 2007-006227-12 . Registration date 18 Mar 2008.

  12. Costs and outcomes after cardiac surgery in patients refusing transfusion compared with those who do not: a case-matched study.

    Science.gov (United States)

    Guinn, Nicole R; Roberson, Russell S; White, William; Cowper, Patricia A; Broomer, Bob; Milano, Carmelo; Chiricolo, Antonio; Hill, Steven

    2015-12-01

    Although numerous studies have demonstrated the feasibility of cardiac surgery for blood refusal patients, few studies match to controls, and fewer examine cost. This historical cohort study aims to compare costs and outcomes after cardiac surgery in Jehovah's Witness patients who refuse blood transfusion with a group of matched patients accepting transfusion. A retrospective database review was performed to find all patients having cardiac surgery who refused blood products from January 2005 to July 2012 at Duke University Medical Center. These 45 patients were closely matched 1:2 with controls who accepted transfusion based on characteristics likely to influence transfusion. Cost from day of surgery to hospital discharge and other outcome data (length of stay [LOS], discharge hemoglobin [Hb], acute kidney injury) were analyzed retrospectively. Forty-five Witnesses having cardiac surgery were temporally matched to two controls having the same surgery. Median euroSCORE was the same in both groups (6.0, p = 0.9981). In the matched-pairs comparison of cost, there was no significant difference in total cost for Witnesses and controls. There was no difference in intensive care unit LOS (median, 1 day, both groups) or total LOS (median, 9 days for Witnesses vs. 7 days for controls). Mean Hb at discharge was higher in Witnesses than in controls (11.7 g/dL vs. 9.8 g/dL, p conservation measures, cardiac surgery may be performed with similar outcomes and cost from day of surgery to discharge compared to controls in select patients without blood transfusion. © 2015 AABB.

  13. Prevention of disease progression by cardiac resynchronization therapy in patients with asymptomatic or mildly symptomatic left ventricular dysfunction: insights from the European cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial

    DEFF Research Database (Denmark)

    Daubert, Claude; Gold, Michael R; Abraham, William T

    2009-01-01

    were decreased in this patient population in New York Heart Association functional classes I or II. These observations suggest that CRT prevents the progression of disease in patients with asymptomatic or mildly symptomatic LV dysfunction. (REsynchronization reVErses Remodeling in Systolic Left v......OBJECTIVES: The aim of this study was to determine the long-term effects of cardiac resynchronization therapy (CRT) in the European cohort of patients enrolled in the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial. BACKGROUND: Previous data suggest...... that CRT slows disease progression and improves the outcomes of asymptomatic or mildly symptomatic patients with left ventricular (LV) dysfunction and a wide QRS complex. METHODS: We randomly assigned 262 recipients of CRT pacemakers or defibrillators, with QRS > or =120 ms and LV ejection fraction...

  14. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

    DEFF Research Database (Denmark)

    Bottomley, Andrew; Pe, Madeline; Sloan, Jeff

    2016-01-01

    Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are anal......Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures...... are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient......-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes...

  15. The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.

    Science.gov (United States)

    Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; O'Brien, Kieran S; Glidden, David V; Ray, Kathryn J; Oldenburg, Catherine E; Zegans, Michael E; Whitcher, John P; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R

    2014-02-01

    To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Randomized, placebo-controlled, double-masked clinical trial. This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials.

    Science.gov (United States)

    Muramatsu, Takashi; Onuma, Yoshinobu; van Geuns, Robert-Jan; Chevalier, Bernard; Patel, Tejas M; Seth, Ashok; Diletti, Roberto; García-García, Hector M; Dorange, Cécile C; Veldhof, Susan; Cheong, Wai-Fung; Ozaki, Yukio; Whitbourn, Robert; Bartorelli, Antonio; Stone, Gregg W; Abizaid, Alexandre; Serruys, Patrick W

    2014-05-01

    The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Clinical outcomes of diabetic patients after BVS implantation have been unreported. This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and

  17. Reperfusion injury protection during Basic Life Support improves circulation and survival outcomes in a porcine model of prolonged cardiac arrest.

    Science.gov (United States)

    Debaty, Guillaume; Lurie, Keith; Metzger, Anja; Lick, Michael; Bartos, Jason A; Rees, Jennifer N; McKnite, Scott; Puertas, Laura; Pepe, Paul; Fowler, Raymond; Yannopoulos, Demetris

    2016-08-01

    Ischemic postconditioning (PC) using three intentional pauses at the start of cardiopulmonary resuscitation (CPR) improves outcomes after cardiac arrest in pigs when epinephrine (epi) is used before defibrillation. We hypothesized PC, performed during basic life support (BLS) in the absence of epinephrine, would reduce reperfusion injury and enhance 24h functional recovery. Prospective animal investigation. Animal laboratory Female farm pigs (n=46, 39±1kg). Protocol A: After 12min of ventricular fibrillation (VF), 28 pigs were randomized to four groups: (A) Standard CPR (SCPR), (B) active compression-decompression CPR with an impedance threshold device (ACD-ITD), (C) SCPR+PC (SCPR+PC) and (D) ACD-ITD CPR+PC. Protocol B: After 15min of VF, 18 pigs were randomized to ACD-ITD CPR or ACD-ITD+PC. The BLS duration was 2.75min in Protocol A and 5min in Protocol B. Following BLS, up to three shocks were delivered. Without return of spontaneous circulation (ROSC), CPR was resumed and epi (0.5mg) and defibrillation delivered. The primary end point was survival without major adverse events. Hemodynamic parameters and left ventricular ejection fraction (LVEF) were also measured. Data are presented as mean±SEM. Protocol A: ACD-ITD+PC (group D) improved coronary perfusion pressure after 3min of BLS versus the three other groups (28±6, 35±7, 23±5 and 47±7 for groups A, B, C, D respectively, p=0.05). There were no significant differences in 24h survival between groups. LVEF 4h post ROSC was significantly higher with ACD-ITD+PC vs ACD-ITD alone (52.5±3% vs. 37.5±6.6%, p=0.045). Survival rates were significantly higher with ACD-ITD+PC vs. ACD-ITD alone (p=0.027). BLS using ACD-ITD+PC reduced post resuscitation cardiac dysfunction and improved functional recovery after prolonged untreated VF in pigs. 12-11. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  18. Resistance in gram-negative bacilli in a cardiac intensive care unit in India: Risk factors and outcome

    Directory of Open Access Journals (Sweden)

    Pawar Mandakini

    2008-01-01

    Full Text Available The objective of this study was to compare the risk factors and outcome of patients with preexisting resistant gram-negative bacilli (GNB with those who develop sensitive GNB in the cardiac intensive care unit (ICU. Of the 3161 patients ( n = 3,161 admitted to the ICU during the study period, 130 (4.11% developed health care-associated infections (HAIs with GNB and were included in the cohort study. Pseudomonas aeruginosa (37.8% was the most common organism isolated followed by Klebsiella species (24.2%, E. coli (22.0%, Enterobacter species (6.1%, Stenotrophomonas maltophilia (5.7%, Acinetobacter species (1.3%, Serratia marcescens (0.8%, Weeksella virosa (0.4% and Burkholderia cepacia (0.4%. Univariate analysis revealed that the following variables were significantly associated with the antibiotic-resistant GNB: females ( P = 0.018, re-exploration ( P = 0.004, valve surgery ( P = 0.003, duration of central venous catheter ( P < 0.001, duration of mechanical ventilation ( P < 0.001, duration of intra-aortic balloon counter-pulsation ( P = 0.018, duration of urinary catheter ( P < 0.001, total number of antibiotic exposures prior to the development of resistance ( P < 0.001, duration of antibiotic use prior to the development of resistance ( P = 0.014, acute physiology and age chronic health evaluation score (APACHE II, receipt of anti-pseudomonal penicillins (piperacillin-tazobactam ( P = 0.002 and carbapenems ( P < 0.001. On multivariate analysis, valve surgery (adjusted OR = 2.033; 95% CI = 1.052-3.928; P = 0.035, duration of mechanical ventilation (adjusted OR = 1.265; 95% CI = 1.055-1.517; P = 0.011 and total number of antibiotic exposure prior to the development of resistance (adjusted OR = 1.381; 95% CI = 1.030-1.853; P = 0.031 were identified as independent risk factors for HAIs in resistant GNB. The mortality rate in patients with resistant GNB was significantly higher than those with sensitive GNB (13.9% vs. 1.8%; P = 0.03. HAI with

  19. Simplified prediction of postoperative cardiac surgery outcomes with a novel score: R2CHADS2.

    Science.gov (United States)

    Peguero, Julio G; Lo Presti, Saberio; Issa, Omar; Podesta, Carlos; Parise, Helen; Layka, Ayman; Brenes, Juan C; Lamelas, Joseph; Lamas, Gervasio A

    2016-07-01

    To compare the accuracy of R2CHADS2, CHADS2, and CHA2DS2-VASc scores vs the Society of Thoracic Surgeons (STS) score as predictors of morbidity and mortality after cardiovascular surgery. All patients who underwent cardiothoracic surgery at our institution from January 2008 to July 2013 were analyzed. Only those patients who fulfilled the criteria for STS score calculation were included. The R2CHADS2 score was computed as follows: 2 points for GFR < 60 mL/min/1.73 m(2) (R2), prior stroke or TIA (S2); 1 point for history of congestive heart failure (C), hypertension (H), age ≥75 years (A), or diabetes (D). Area under the curve (AUC) analysis was used to estimate the accuracy of the different scores. The end point variables included operative mortality, permanent stroke, and renal failure as defined by the STS database system. Of the 3,492 patients screened, 2,263 met the inclusion criteria. These included 1,160 (51%) isolated valve surgery, 859 (38%) coronary artery bypass graft surgery, and 245 (11%) combined procedures. There were 147 postoperative events: 75 (3%) patients had postoperative renal failure, 48 (2%) had operative mortality, and 24 (1%) had permanent stroke. AUC analysis revealed that STS, R2CHADS2, CHADS2, and CHA2DS2-VASc reliably estimated all postoperative outcomes. STS and R2CHADS2 scores had the best accuracy overall, with no significant difference in AUC values between them. The R2CHADS2 score estimates postoperative events with acceptable accuracy and if further validated may be used as a simple preoperative risk tool calculator. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Making an APPropriate Care Program for Indigenous Cardiac Disease: Customization of an Existing Cardiac Rehabilitation Program.

    Science.gov (United States)

    Bradford, DanaKai; Hansen, David; Karunanithi, Mohan

    2015-01-01

    Cardiovascular disease is a major health problem for all Australians and is the leading cause of death in Aboriginal and Torres Strait Islanders. In 2010, more then 50% of all heart attack deaths were due to repeated events. Cardiac rehabilitation programs have been proven to be effective in preventing the recurrence of cardiac events and readmission to hospitals. There are however, many barriers to the use of these programs. To address these barriers, CSIRO developed an IT enabled cardiac rehabilitation program delivered by mobile phone through a smartphone app and succesfully trialed it in an urban general population. If these results can be replicated in Indigenous populations, the program has the potential to significantly improve life expectancy and help close the gap in health outcomes. The challenge described in this paper is customizing the existing cardiac health program to make it culturally relevant and suitable for Indigenous Australians living in urban and remote communities.

  1. Advanced Cardiac Resuscitation Evaluation (ACRE: A randomised single-blind controlled trial of peer-led vs. expert-led advanced resuscitation training

    Directory of Open Access Journals (Sweden)

    Hughes Thomas C

    2010-01-01

    Full Text Available Abstract Background Advanced resuscitation skills training is an important and enjoyable part of medical training, but requires small group instruction to ensure active participation of all students. Increases in student numbers have made this increasingly difficult to achieve. Methods A single-blind randomised controlled trial of peer-led vs. expert-led resuscitation training was performed using a group of sixth-year medical students as peer instructors. The expert instructors were a senior and a middle grade doctor, and a nurse who is an Advanced Life Support (ALS Instructor. A power calculation showed that the trial would have a greater than 90% chance of rejecting the null hypothesis (that expert-led groups performed 20% better than peer-led groups if that were the true situation. Secondary outcome measures were the proportion of High Pass grades in each groups and safety incidents. The peer instructors designed and delivered their own course material. To ensure safety, the peer-led groups used modified defibrillators that could deliver only low-energy shocks. Blinded assessment was conducted using an Objective Structured Clinical Examination (OSCE. The checklist items were based on International Liaison Committee on Resuscitation (ILCOR guidelines using Ebel standard-setting methods that emphasised patient and staff safety and clinical effectiveness. The results were analysed using Exact methods, chi-squared and t-test. Results A total of 132 students were randomised: 58 into the expert-led group, 74 into the peer-led group. 57/58 (98% of students from the expert-led group achieved a Pass compared to 72/74 (97% from the peer-led group: Exact statistics confirmed that it was very unlikely (p = 0.0001 that the expert-led group was 20% better than the peer-led group. There were no safety incidents, and High Pass grades were achieved by 64 (49% of students: 33/58 (57% from the expert-led group, 31/74 (42% from the peer-led group. Exact

  2. Clinical outcomes assessment in clinical trials to assess treatment of femoroacetabular impingement

    DEFF Research Database (Denmark)

    Harris-Hayes, Marcie; McDonough, Christine M; Leunig, Michael

    2013-01-01

    Patient-reported outcome measures are an important component of outcomes assessment in clinical trials to assess the treatment of femoroacetabular impingement (FAI). This review of disease-specific measures and instruments used to assess the generic quality of life and physical activity levels...... developed recently and have not been established in the literature. Although currently used generic and activity-level measures have limitations, as well, they should be considered, depending on the specific goals of the study. Additional research is needed to assess the properties of these measures fully...

  3. Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial

    Directory of Open Access Journals (Sweden)

    Scherjon Sicco A

    2009-09-01

    Full Text Available Abstract Background Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. Methods/Design The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention or placebo (control for twelve days or until delivery, whatever comes first. Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, β 0.2 at alpha 0.05. Discussion This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. Trial Registration Clinical trial registration: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.

  4. Cardiac Toxicity After Radiotherapy for Stage III Non–Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy

    Science.gov (United States)

    Eblan, Michael J.; Deal, Allison M.; Lipner, Matthew; Zagar, Timothy M.; Wang, Yue; Mavroidis, Panayiotis; Lee, Carrie B.; Jensen, Brian C.; Rosenman, Julian G.; Socinski, Mark A.; Stinchcombe, Thomas E.; Marks, Lawrence B.

    2017-01-01

    Purpose The significance of radiotherapy (RT) –associated cardiac injury for stage III non–small-cell lung cancer (NSCLC) is unclear, but higher heart doses were associated with worse overall survival in the Radiation Therapy Oncology Group (RTOG) 0617 study. We assessed the impact of heart dose in patients treated at our institution on several prospective dose-escalation trials. Patients and Methods From 1996 to 2009, 127 patients with stage III NSCLC (Eastern Cooperative Oncology Group performance status, 0 to 1) received dose-escalated RT to 70 to 90 Gy (median, 74 Gy) in six trials. RT plans and cardiac doses were reviewed. Records were reviewed for the primary end point: symptomatic cardiac events (symptomatic pericardial effusion, acute coronary syndrome, pericarditis, significant arrhythmia, and heart failure). Cardiac risk was assessed by noting baseline coronary artery disease and calculating the WHO/International Society of Hypertension score. Competing risks analysis was used. Results In all, 112 patients were analyzed. Median follow-up for surviving patients was 8.8 years. Twenty-six patients (23%) had one or more events at a median of 26 months to first event (effusion [n = 7], myocardial infarction [n = 5], unstable angina [n = 3], pericarditis [n = 2], arrhythmia [n = 12], and heart failure [n = 1]). Heart doses (eg, heart mean dose; hazard ratio, 1.03/Gy; P = .002,), coronary artery disease (P < .001), and WHO/International Society of Hypertension score (P = .04) were associated with events on univariable analysis. Heart doses remained significant on multivariable analysis that accounted for baseline risk. Two-year competing risk–adjusted event rates for patients with heart mean dose < 10 Gy, 10 to 20 Gy, or ≥ 20 Gy were 4%, 7%, and 21%, respectively. Heart doses were not associated with overall survival. Conclusion Cardiac events were relatively common after high-dose thoracic RT and were independently associated with both heart dose and

  5. Cross-trial prediction of treatment outcome in depression: a machine learning approach.

    Science.gov (United States)

    Chekroud, Adam Mourad; Zotti, Ryan Joseph; Shehzad, Zarrar; Gueorguieva, Ralitza; Johnson, Marcia K; Trivedi, Madhukar H; Cannon, Tyrone D; Krystal, John Harrison; Corlett, Philip Robert

    2016-03-01

    Antidepressant treatment efficacy is low, but might be improved by matching patients to interventions. At present, clinicians have no empirically validated mechanisms to assess whether a patient with depression will respond to a specific antidepressant. We aimed to develop an algorithm to assess whether patients will achieve symptomatic remission from a 12-week course of citalopram. We used patient-reported data from patients with depression (n=4041, with 1949 completers) from level 1 of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D; ClinicalTrials.gov, number NCT00021528) to identify variables that were most predictive of treatment outcome, and used these variables to train a machine-learning model to predict clinical remission. We externally validated the model in the escitalopram treatment group (n=151) of an independent clinical trial (Combining Medications to Enhance Depression Outcomes [COMED]; ClinicalTrials.gov, number NCT00590863). We identified 25 variables that were most predictive of treatment outcome from 164 patient-reportable variables, and used these to train the model. The model was internally cross-validated, and predicted outcomes in the STAR*D cohort with accuracy significantly above chance (64·6% [SD 3·2]; p<0·0001). The model was externally validated in the escitalopram treatment group (N=151) of COMED (accuracy 59·6%, p=0.043). The model also performed significantly above chance in a combined escitalopram-buproprion treatment group in COMED (n=134; accuracy 59·7%, p=0·023), but not in a combined venlafaxine-mirtazapine group (n=140; accuracy 51·4%, p=0·53), suggesting specificity of the model to underlying mechanisms. Building statistical models by mining existing clinical trial data can enable prospective identification of patients who are likely to respond to a specific antidepressant. Yale University. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Surgeon length of service and risk-adjusted outcomes: linked observational analysis of the UK National Adult Cardiac Surgery Audit Registry and General Medical Council Register.

    Science.gov (United States)

    Hickey, Graeme L; Grant, Stuart W; Freemantle, Nick; Cunningham, David; Munsch, Christopher M; Livesey, Steven A; Roxburgh, James; Buchan, Iain; Bridgewater, Ben

    2014-09-01

    To explore the relationship between in-hospital mortality following adult cardiac surgery and the time since primary clinical qualification for the responsible consultant cardiac surgeon (a proxy for experience). Retrospective analysis of prospectively collected national registry data over a 10-year period using mixed-effects multiple logistic regression modelling. Surgeon experience was defined as the time between the date of surgery and award of primary clinical qualification. UK National Health Service hospitals performing cardiac surgery between January 2003 and December 2012. All patients undergoing coronary artery bypass grafts and/or valve surgery under the care of a consultant cardiac surgeon. All-cause in-hospital mortality. A total of 292,973 operations performed by 273 consultant surgeons (with lengths of service from 11.2 to 42.0 years) were included. Crude mortality increased approximately linearly until 33 years service, before decreasing. After adjusting for case-mix and year of surgery, there remained a statistically significant (p=0.002) association between length of service and in-hospital mortality (odds ratio 1.013; 95% CI 1.005-1.021 for each year of 'experience'). Consultant cardiac surgeons take on increasingly complex surgery as they gain experience. With this progression, the incidence of adverse outcomes is expected to increase, as is demonstrated in this study. After adjusting for case-mix using the EuroSCORE, we observed an increased risk of mortality in patients operated on by longer serving surgeons. This finding may reflect under-adjustment for risk, unmeasured confounding or a real association. Further research into outcomes over the time course of surgeon's careers is required. © The Royal Society of Medicine.

  7. Milrinone for cardiac dysfunction in critically ill adult patients : a systematic review of randomised clinical trials with meta-analysis and trial sequential analysis

    NARCIS (Netherlands)

    Koster, Geert; Bekema, Hanneke J.; Wetterslev, Jorn; Gluud, Christian; Keus, Frederik; van der Horst, Iwan C. C.

    Milrinone is an inotrope widely used for treatment of cardiac failure. Because previous meta-analyses had methodological flaws, we decided to conduct a systematic review of the effect of milrinone in critically ill adult patients with cardiac dysfunction. This systematic review was performed

  8. Intra-operative intravenous fluid restriction reduces perioperative red blood cell transfusion in elective cardiac surgery, especially in transfusion-prone patients: a prospective, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Georgopoulou Stavroula

    2010-02-01

    Full Text Available Abstract Background Cardiac surgery is a major consumer of blood products, and hemodilution increases transfusion requirements during cardiac surgery under CPB. As intraoperative parenteral fluids contribute to hemodilution, we evaluated the hypothesis that intraoperative fluid restriction reduces packed red-cell (PRC use, especially in transfusion-prone adults undergoing elective cardiac surgery. Methods 192 patients were randomly assigned to restrictive (group A, 100 pts, or liberal (group B, 92 pts intraoperative intravenous fluid administration. All operations were conducted by the same team (same surgeon and perfusionist. After anesthesia induction, intravenous fluids were turned off in Group A (fluid restriction patients, who only received fluids if directed by protocol. In contrast, intravenous fluid administration was unrestricted in group B. Transfusion decisions were made by the attending anesthesiologist, based on identical transfusion guidelines for both groups. Results 137 of 192 patients received 289 PRC units in total. Age, sex, weight, height, BMI, BSA, LVEF, CPB duration and surgery duration did not differ between groups. Fluid balance was less positive in Group A. Fewer group A patients (62/100 required transfusion compared to group B (75/92, p Conclusions Our data suggest that fluid restriction reduces intraoperative PRC transfusions without significantly increasing postoperative transfusions in cardiac surgery; this effect is more pronounced in transfusion-prone patients. Trial registration NCT00600704, at the United States National Institutes of Health.

  9. Cardiac Stress and Inflammatory Markers as Predictors of Heart Failure in Patients With Type 2 Diabetes: The ADVANCE Trial.

    Science.gov (United States)

    Ohkuma, Toshiaki; Jun, Min; Woodward, Mark; Zoungas, Sophia; Cooper, Mark E; Grobbee, Diederick E; Hamet, Pavel; Mancia, Giuseppe; Williams, Bryan; Welsh, Paul; Sattar, Naveed; Shaw, Jonathan E; Rahimi, Kazem; Chalmers, John

    2017-09-01

    This study examined the individual and combined effect of N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), interleukin-6 (IL-6), and hs-CRP on the prediction of heart failure incidence or progression in patients with type 2 diabetes. A nested case-cohort study was conducted in 3,098 participants with type 2 diabetes in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. A higher value of each biomarker was significantly associated with a higher risk of heart failure incidence or progression, after adjustment for major risk factors. The hazard ratios per 1-SD increase were 3.06 (95% CI 2.37, 3.96) for NT-proBNP, 1.50 (1.27, 1.77) for hs-cTnT, 1.48 (1.27, 1.72) for IL-6, and 1.32 (1.12, 1.55) for hs-CRP. The addition of NT-proBNP to the model including conventional risk factors meaningfully improved 5-year risk-predictive performance (C statistic 0.8162 to 0.8800; continuous net reclassification improvement [NRI] 73.1%; categorical NRI [10% 5-year risk] 24.2%). In contrast, the addition of hs-cTnT, IL-6, or hs-CRP did not improve the prediction metrics consistently in combination or when added to NT-proBNP. Only NT-proBNP strongly and consistently improved the prediction of heart failure in patients with type 2 diabetes beyond a wide range of clinical risk factors and biomarkers. © 2017 by the American Diabetes Association.

  10. Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

    Science.gov (United States)

    Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

    2016-11-20

    High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

  11. Factors and outcomes of decision making for cancer clinical trial participation.

    Science.gov (United States)

    Biedrzycki, Barbara A

    2011-09-01

    To describe factors and outcomes related to the decision-making process regarding participation in a cancer clinical trial. Cross-sectional, descriptive. Urban, academic, National Cancer Institute-designated comprehensive cancer center in the mid-Atlantic United States. 197 patients with advanced gastrointestinal cancer. Mailed survey using one investigator-developed instrument, eight instruments used in published research, and a medical record review. disease context, sociodemographics, hope, quality of life, trust in healthcare system, trust in health professional, preference for research decision control, understanding risks, and information. decision to accept or decline research participation and satisfaction with this decision. All of the factors within the Research Decision Making Model together predicted cancer clinical trial participation and satisfaction with this decision. The most frequently preferred decision-making style for research participation was shared (collaborative) (83%). Multiple factors affect decision making for cancer clinical trial participation and satisfaction with this decision. Shared decision making previously was an unrecognized factor and requires further investigation. Enhancing the process of research decision making may facilitate an increase in cancer clinical trial enrollment rates. Oncology nurses have unique opportunities as educators and researchers to support shared decision making by those who prefer this method for deciding whether to accept or decline cancer clinical trial participation.

  12. The Impacts of Inclusion in Clinical Trials on Outcomes among Patients with Metastatic Breast Cancer (MBC.

    Directory of Open Access Journals (Sweden)

    Ji Yun Lee

    Full Text Available Metastatic breast cancer (MBC remains a devastating and incurable disease. Over the past decade, the implementation of clinical trials both with and without molecular targeted therapeutics has impacted the daily clinical treatment of patients with MBC. In this study, we determine whether including MBC patients in clinical trials affects clinical outcomes.We retrospectively reviewed data for a total of 863 patients diagnosed with initial or recurrent (after receiving adjuvant systemic treatments following surgery metastatic disease between January 2000 and December 2013. Data were obtained from the breast cancer database of Samsung Medical Center.Among the 806 patients selected for inclusion, 188 (23% had participated in clinical trials. A total of 185 clinical trials were conducted from 2000 to 2014. When compared with earlier periods (n = 10 for 2000-2004, clinical trial enrollment significantly increased over time (n = 103 for 2005-2009, P = 0.024; n = 110 for 2010-2014, P = 0.046. Multivariate analyses revealed that biologic subtype, distant recurrence free interval (DRFI, and clinical trial enrollment were independent predictors of overall survival. Patients who participated in clinical trials showed improved survival, with a hazard ratio of 0.75 (95% CI, 0.59-0.95, which was associated with a 25% reduction in the risk of death. However, subgroup analysis showed that this improved survival benefit was not maintained in patients with triple negative breast cancer (TNBC.Although not conclusive, we could speculate that there were differences in the use of newer agents or regimens over time, and these differences appear to be associated with improved survival.

  13. A simple method for analyzing data from a randomized trial with a missing binary outcome

    Directory of Open Access Journals (Sweden)

    Freedman Laurence S

    2003-05-01

    Full Text Available Abstract Background Many randomized trials involve missing binary outcomes. Although many previous adjustments for missing binary outcomes have been proposed, none of these makes explicit use of randomization to bound the bias when the data are not missing at random. Methods We propose a novel approach that uses the randomization distribution to compute the anticipated maximum bias when missing at random does not hold due to an unobserved binary covariate (implying that missingness depends on outcome and treatment group. The anticipated maximum bias equals the product of two factors: (a the anticipated maximum bias if there were complete confounding of the unobserved covariate with treatment group among subjects with an observed outcome and (b an upper bound factor that depends only on the fraction missing in each randomization group. If less than 15% of subjects are missing in each group, the upper bound factor is less than .18. Results We illustrated the methodology using data from the Polyp Prevention Trial. We anticipated a maximum bias under complete confounding of .25. With only 7% and 9% missing in each arm, the upper bound factor, after adjusting for age and sex, was .10. The anticipated maximum bias of .25 × .10 =.025 would not have affected the conclusion of no treatment effect. Conclusion This approach is easy to implement and is particularly informative when less than 15% of subjects are missing in each arm.

  14. Impact of on-site cardiac catheterization on resource utilization and fatal and non-fatal outcomes after acute myocardial infarction

    Directory of Open Access Journals (Sweden)

    Richard Hugues

    2006-11-01

    Full Text Available Abstract Background Patterns of care for acute myocardial infarction (AMI strongly depend on the availability of on-site cardiac catheterization facilities. Although the management found at hospitals without on-site catheterization does not lead to increased mortality, little it known about its impact on resource utilization and non-fatal outcomes. Methods We identified all patients (n = 35,289 admitted with a first AMI in the province of Quebec between January 1, 1996 and March 31, 1999 using population-based administrative databases. Medical resource utilization and non-fatal and fatal outcomes were compared among patients admitted to hospitals with and without on-site cardiac catheterization facilities. Results Cardiac catheterization and PCI were more frequently performed among patients admitted to hospitals with catheterization facilities. However, non-invasive procedures were not used more frequently at hospitals without catheterization facilities. To the contrary, echocardiography [odds ratio (OR, 2.04; 95% confidence interval (CI, 1.93–2.16] and multi-gated acquisition imaging (OR, 1.24; 95% CI, 1.17–1.32 were used more frequently at hospitals with catheterization, and exercise treadmill testing (OR, 1.02; 95% CI, 0.91–1.15 and Sestamibi/Thallium imaging (OR, 0.93; 95% CI, 0.88–0.98 were used similarly at hospitals with and without catheterization. Use of anti-ischemic medications and frequency of emergency room and physician visits, were similar at both types of institutions. Readmission rates for AMI-related cardiac complications and mortality were also similar [adjusted hazard ratio, recurrent AMI: 1.02, 95% CI, 0.89–1.16; congestive heart failure: 1.02; 95% CI, 0.90–1.15; unstable angina: 0.93; 95% CI, 0.85–1.02; mortality: 0.99; 95% CI, 0.93–1.05]. Conclusion Although on-site availability of cardiac catheterization facilities is associated with greater use of invasive cardiac procedures, non-availability of

  15. Effect of battery longevity on costs and health outcomes associated with cardiac implantable electronic devices: a Markov model-based Monte Carlo simulation.

    Science.gov (United States)

    Schmier, Jordana K; Lau, Edmund C; Patel, Jasmine D; Klenk, Juergen A; Greenspon, Arnold J

    2017-11-01

    The effects of device and patient characteristics on health and economic outcomes in patients with cardiac implantable electronic devices (CIEDs) are unclear. Modeling can estimate costs and outcomes for patients with CIEDs under a variety of scenarios, varying battery longevity, comorbidities, and care settings. The objective of this analysis was to compare changes in patient outcomes and payer costs attributable to increases in battery life of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D). We developed a Monte Carlo Markov model simulation to follow patients through primary implant, postoperative maintenance, generator replacement, and revision states. Patients were simulated in 3-month increments for 15 years or until death. Key variables included Charlson Comorbidity Index, CIED type, legacy versus extended battery longevity, mortality rates (procedure and all-cause), infection and non-infectious complication rates, and care settings. Costs included procedure-related (facility and professional), maintenance, and infections and non-infectious complications, all derived from Medicare data (2004-2014, 5% sample). Outcomes included counts of battery replacements, revisions, infections and non-infectious complications, and discounted (3%) costs and life years. An increase in battery longevity in ICDs yielded reductions in numbers of revisions (by 23%), battery changes (by 44%), infections (by 23%), non-infectious complications (by 10%), and total costs per patient (by 9%). Analogous reductions for CRT-Ds were 23% (revisions), 32% (battery changes), 22% (infections), 8% (complications), and 10% (costs). Based on modeling results, as battery longevity increases, patients experience fewer adverse outcomes and healthcare costs are reduced. Understanding the magnitude of the cost benefit of extended battery life can inform budgeting and planning decisions by healthcare providers and insurers.

  16. Randomized Control Trial of COMPASS for Improving Transition Outcomes of Students with Autism Spectrum Disorder.

    Science.gov (United States)

    Ruble, Lisa A; McGrew, John H; Toland, Michael; Dalrymple, Nancy; Adams, Medina; Snell-Rood, Claire

    2018-06-01

    The postsecondary outcomes of individuals with autism spectrum disorder (ASD) are significantly worse than peers with other disabilities. One problem is the lack of empirically-supported transition planning interventions to guide services and help produce better outcomes. We applied an implementation science approach to adapt and modify an evidence-based consultation intervention originally tested with young children called the Collaborative Model for Promoting Competence and Success (COMPASS; Ruble et al., The collaborative model for promoting competence and success for students with ASD. Springer, New York, 2012a) and evaluate it for efficacy in a randomized controlled trial for transition-age youth. Results replicated findings with younger students with ASD that IEP outcomes were higher for COMPASS compared to the placebo control group (d = 2.1). Consultant fidelity was high and teacher adherence improved over time, replicating the importance of ongoing teacher coaching.

  17. Revisiting blood transfusion and predictors of outcome in cardiac surgery patients: a concise perspective [version 1; referees: 2 approved

    OpenAIRE

    Carlos E Arias-Morales; Nicoleta Stoicea; Alicia A Gonzalez-Zacarias; Diana Slawski; Sujatha P. Bhandary; Theodosios Saranteas; Eva Kaminiotis; Thomas J Papadimos

    2017-01-01

    In the United States, cardiac surgery-related blood transfusion rates reached new highs in 2010, with 34% of patients receiving blood products. Patients undergoing both complex (coronary artery bypass grafting [CABG] plus valve repair or replacement) and non-complex (isolated CABG) cardiac surgeries are likely to have comorbidities such as anemia. Furthermore, the majority of patients undergoing isolated CABG have a history of myocardial infarction. These characteristics may increase the risk...

  18. Outcomes of combined cardiovascular risk factor management strategies in type 2 diabetes: the ACCORD randomized trial.

    Science.gov (United States)

    Margolis, Karen L; O'Connor, Patrick J; Morgan, Timothy M; Buse, John B; Cohen, Robert M; Cushman, William C; Cutler, Jeffrey A; Evans, Gregory W; Gerstein, Hertzel C; Grimm, Richard H; Lipkin, Edward W; Narayan, K M Venkat; Riddle, Matthew C; Sood, Ajay; Goff, David C

    2014-06-01

    To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of risk of the primary outcome was lower in the groups intensively treated for glycemia (hazard ratio [HR] 0.67; 95% CI 0.50-0.91), BP (HR 0.74; 95% CI 0.55-1.00), or both (HR 0.71; 95% CI 0.52-0.96) compared with combined standard BP and glycemia treatment. For secondary outcomes, MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment; most other HRs were neutral or favored intensive treatment groups. In the lipid trial, the general pattern of results showed no evidence of benefit of intensive regimens (whether single or combined) compared with combined standard lipid and glycemia treatment. The mortality HR was 1.33 (95% CI 1.02-1.74) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group. In the ACCORD BP trial, compared with combined standard treatment, intensive BP or intensive glycemia treatment alone improved major CVD outcomes, without additional benefit from combining the two. In the ACCORD lipid trial, neither intensive lipid nor glycemia treatment produced an overall benefit, but intensive glycemia treatment increased mortality. © 2014 by the American Diabetes Association.

  19. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study.

    Science.gov (United States)

    Ahn, Rosa; Woodbridge, Alexandra; Abraham, Ann; Saba, Susan; Korenstein, Deborah; Madden, Erin; Boscardin, W John; Keyhani, Salomeh

    2017-01-17

     To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.  Cross sectional study of randomized controlled trials (RCTs).  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.  Random sample of RCTs focused on drug efficacy.  Association between financial ties of principal investigators and study outcome.  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1

  20. The Effect of Dexamethasone on Symptoms of Posttraumatic Stress Disorder and Depression After Cardiac Surgery and Intensive Care Admission: Longitudinal Follow-Up of a Randomized Controlled Trial.

    Science.gov (United States)

    Kok, Lotte; Hillegers, Manon H; Veldhuijzen, Dieuwke S; Cornelisse, Sandra; Nierich, Arno P; van der Maaten, Joost M; Rosseel, Peter M; Hofland, Jan; Sep, Milou S; Dieleman, Jan M; Vinkers, Christiaan H; Peelen, Linda M; Joëls, Marian; van Dijk, Diederik

    2016-03-01

    Cardiac surgery and postoperative admission to the ICU may lead to posttraumatic stress disorder and depression. Perioperatively administered corticosteroids potentially alter the risk of development of these psychiatric conditions, by affecting the hypothalamic-pituitary-adrenal axis. However, findings of previous studies are inconsistent. We aimed to assess the effect of a single dose of dexamethasone compared with placebo on symptoms of posttraumatic stress disorder and depression and health-related quality of life after cardiac surgery and ICU admission. Follow-up study of a randomized clinical trial. Five Dutch heart centers. Cardiac surgery patients (n = 1,244) who participated in the Dexamethasone for Cardiac Surgery trial. A single intraoperative IV dose of dexamethasone or placebo was administered in a randomized, double-blind way. Symptoms of posttraumatic stress disorder, depression, and health-related quality of life were assessed with validated questionnaires 1.5 years after randomization. Data were available for 1,125 patients (90.4%); of which 561 patients received dexamethasone and 564 patients received placebo. Overall, the prevalence of psychopathology was not influenced by dexamethasone. Posttraumatic stress disorder and depression were present in, respectively, 52 patients (9.3%) and 69 patients (12.3%) who received dexamethasone and in 66 patients (11.7%) and 78 patients (13.8%) who received placebo (posttraumatic stress disorder: odds ratio, 0.82; 95% CI, 0.55-1.20; p = 0.30; depression: odds ratio, 0.92; 95% CI, 0.64-1.31; p = 0.63). Subgroup analysis revealed a lower prevalence of posttraumatic stress disorder (odds ratio, 0.23; 95% CI, 0.07-0.72; p stress disorder and depression. However, in female patients, beneficial effects on the occurrence of posttraumatic stress disorder and depression may be present.

  1. SPECT Analysis of Cardiac Perfusion Changes After Whole-Breast/Chest Wall Radiation Therapy With or Without Active Breathing Coordinator: Results of a Randomized Phase 3 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Zellars, Richard, E-mail: zellari@jhmi.edu [Johns Hopkins Medical Institution, Baltimore, Maryland (United States); Bravo, Paco E. [University of Washington Medical Center, Seattle, Washington (United States); Tryggestad, Erik [Mayo Clinic, Rochester, Minnesota (United States); Hopfer, Kari [Hahnemann University, Philadelphia, Pennsylvania (United States); Myers, Lee; Tahari, Abdel; Asrari, Fariba; Ziessman, Harvey [Johns Hopkins Medical Institution, Baltimore, Maryland (United States); Garrett-Mayer, Elizabeth [Medical University of South Carolina, Charleston, South Carolina (United States)

    2014-03-15

    Purpose: Cardiac muscle perfusion, as determined by single-photon emission computed tomography (SPECT), decreases after breast and/or chest wall (BCW) irradiation. The active breathing coordinator (ABC) enables radiation delivery when the BCW is farther from the heart, thereby decreasing cardiac exposure. We hypothesized that ABC would prevent radiation-induced cardiac toxicity and conducted a randomized controlled trial evaluating myocardial perfusion changes after radiation for left-sided breast cancer with or without ABC. Methods and Materials: Stages I to III left breast cancer patients requiring adjuvant radiation therapy (XRT) were randomized to ABC or No-ABC. Myocardial perfusion was evaluated by SPECT scans (before and 6 months after BCW radiation) using 2 methods: (1) fully automated quantitative polar mapping; and (2) semiquantitative visual assessment. The left ventricle was divided into 20 segments for the polar map and 17 segments for the visual method. Segments were grouped by anatomical rings (apical, mid, basal) or by coronary artery distribution. For the visual method, 2 nuclear medicine physicians, blinded to treatment groups, scored each segment's perfusion. Scores were analyzed with nonparametric tests and linear regression. Results: Between 2006 and 2010, 57 patients were enrolled and 43 were available for analysis. The cohorts were well matched. The apical and left anterior descending coronary artery segments had significant decreases in perfusion on SPECT scans in both ABC and No-ABC cohorts. In unadjusted and adjusted analyses, controlling for pretreatment perfusion score, age, and chemotherapy, ABC was not significantly associated with prevention of perfusion deficits. Conclusions: In this randomized controlled trial, ABC does not appear to prevent radiation-induced cardiac perfusion deficits.

  2. SPECT Analysis of Cardiac Perfusion Changes After Whole-Breast/Chest Wall Radiation Therapy With or Without Active Breathing Coordinator: Results of a Randomized Phase 3 Trial

    International Nuclear Information System (INIS)

    Zellars, Richard; Bravo, Paco E.; Tryggestad, Erik; Hopfer, Kari; Myers, Lee; Tahari, Abdel; Asrari, Fariba; Ziessman, Harvey; Garrett-Mayer, Elizabeth

    2014-01-01

    Purpose: Cardiac muscle perfusion, as determined by single-photon emission computed tomography (SPECT), decreases after breast and/or chest wall (BCW) irradiation. The active breathing coordinator (ABC) enables radiation delivery when the BCW is farther from the heart, thereby decreasing cardiac exposure. We hypothesized that ABC would prevent radiation-induced cardiac toxicity and conducted a randomized controlled trial evaluating myocardial perfusion changes after radiation for left-sided breast cancer with or without ABC. Methods and Materials: Stages I to III left breast cancer patients requiring adjuvant radiation therapy (XRT) were randomized to ABC or No-ABC. Myocardial perfusion was evaluated by SPECT scans (before and 6 months after BCW radiation) using 2 methods: (1) fully automated quantitative polar mapping; and (2) semiquantitative visual assessment. The left ventricle was divided into 20 segments for the polar map and 17 segments for the visual method. Segments were grouped by anatomical rings (apical, mid, basal) or by coronary artery distribution. For the visual method, 2 nuclear medicine physicians, blinded to treatment groups, scored each segment's perfusion. Scores were analyzed with nonparametric tests and linear regression. Results: Between 2006 and 2010, 57 patients were enrolled and 43 were available for analysis. The cohorts were well matched. The apical and left anterior descending coronary artery segments had significant decreases in perfusion on SPECT scans in both ABC and No-ABC cohorts. In unadjusted and adjusted analyses, controlling for pretreatment perfusion score, age, and chemotherapy, ABC was not significantly associated with prevention of perfusion deficits. Conclusions: In this randomized controlled trial, ABC does not appear to prevent radiation-induced cardiac perfusion deficits

  3. Neurosurgical outcomes after intracerebral hemorrhage: results of the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST).

    Science.gov (United States)

    Steiner, Thorsten; Vincent, Catherine; Morris, Stephen; Davis, Stephen; Vallejo-Torres, Laura; Christensen, Michael C

    2011-01-01

    The value of neurosurgical interventions after spontaneous intracerebral hemorrhage (SICH) is uncertain. We evaluated clinical outcomes in patients diagnosed with SICH within 3 hours of symptom onset who underwent hematoma evacuation or external ventricular drainage (EVD) of the hematoma in the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST). FAST was a randomized, multicenter, double-blind, placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries. Neurosurgical procedures (hematoma evacuation and external ventricular drainage) performed at any point after hospital admission were prospectively recorded. Clinical outcomes evaluated were post-SICH disability, as assessed by the modified Rankin Scale; neurologic impairment, as assessed by the National Institutes of Health Stroke Scale; and mortality at 90 days after SICH onset. The impact of neurosurgical procedures on clinical outcomes was evaluated using multivariate logistic regression analysis, controlling for relevant baseline characteristics. Fifty-five of 821 patients underwent neurosurgery. Patients who underwent hematoma evacuation or EVD were on average younger, had greater baseline neurologic impairment, and lower levels of consciousness compared with patients who did not undergo neurosurgery. After adjusting for these differences and other relevant baseline characteristics, we found that neurosurgery was generally associated with unfavorable outcomes at day 90. Among the patients who underwent hematoma evacuation, those with lobar ICH had less ICH expansion than those with deep gray matter ICH, and the smaller expansion was associated with lower mortality. ICH volume was substantially decreased in patients who underwent hematoma evacuation between 24 and 72 hours after hospital admission, and this was associated with better clinical outcome. In conclusion, a small number of patients who underwent neurosurgery in FAST exhibited no overall clinical benefit

  4. Cardiac Outcomes After Ischemic Stroke or Transient Ischemic Attack: Effects of Pioglitazone in Patients With Insulin Resistance Without Diabetes Mellitus.

    Science.gov (United States)

    Young, Lawrence H; Viscoli, Catherine M; Curtis, Jeptha P; Inzucchi, Silvio E; Schwartz, Gregory G; Lovejoy, Anne M; Furie, Karen L; Gorman, Mark J; Conwit, Robin; Abbott, J Dawn; Jacoby, Daniel L; Kolansky, Daniel M; Pfau, Steven E; Ling, Frederick S; Kernan, Walter N

    2017-05-16

    Insulin resistance is highly prevalent among patients with atherosclerosis and is associated with an increased risk for myocardial infarction (MI) and stroke. The IRIS trial (Insulin Resistance Intervention after Stroke) demonstrated that pioglitazone decreased the composite risk for fatal or nonfatal stroke and MI in patients with insulin resistance without diabetes mellitus, after a recent ischemic stroke or transient ischemic attack. The type and severity of cardiac events in this population and the impact of pioglitazone on these events have not been described. We performed a secondary analysis of the effects of pioglitazone, in comparison with placebo, on acute coronary syndromes (MI and unstable angina) among IRIS participants. All potential acute coronary syndrome episodes were adjudicated in a blinded fashion by an independent clinical events committee. The study cohort was composed of 3876 IRIS participants, mean age 63 years, 65% male, 89% white race, and 12% with a history of coronary artery disease. Over a median follow-up of 4.8 years, there were 225 acute coronary syndrome events, including 141 MIs and 84 episodes of unstable angina. The MIs included 28 (19%) with ST-segment elevation. The majority of MIs were type 1 (94, 65%), followed by type 2 (45, 32%). Serum troponin was 10× to 100× upper limit of normal in 49 (35%) and >100× upper limit of normal in 39 (28%). Pioglitazone reduced the risk of acute coronary syndrome (hazard ratio, 0.71; 95% confidence interval, 0.54-0.94; P =0.02). Pioglitazone also reduced the risk of type 1 MI (hazard ratio, 0.62; 95% confidence interval, 0.40-0.96; log-rank P =0.03), but not type 2 MI (hazard ratio, 1.05; 95% confidence interval, 0.58-1.91; P =0.87). Similarly, pioglitazone reduced the risk of large MIs with serum troponin >100× upper limit of normal (hazard ratio, 0.44; 95% confidence interval, 0.22-0.87; P =0.02), but not smaller MIs. Among patients with insulin resistance without diabetes mellitus

  5. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review.

    Directory of Open Access Journals (Sweden)

    Marnie L Elizaga

    Full Text Available Vaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines.Four clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. 'Routine cardiac investigations' (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls, and 'Symptom-driven cardiac investigations' are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine.Four hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12% had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine.Prospective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants.ClinicalTrials.gov NCT00082446 NCT003766090 NCT00252148 NCT00083603 NCT00301184 NCT00428337.

  6. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review.

    Science.gov (United States)

    Elizaga, Marnie L; Vasan, Sandhya; Marovich, Mary A; Sato, Alicia H; Lawrence, Dale N; Chaitman, Bernard R; Frey, Sharon E; Keefer, Michael C

    2013-01-01

    Vaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax) campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA) has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines. Four clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. 'Routine cardiac investigations' (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls), and 'Symptom-driven cardiac investigations' are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine. Four hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12%) had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine. Prospective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants. ClinicalTrials.gov NCT00082446 NCT003766090 NCT00252148 NCT00083603 NCT00301184 NCT00428337.

  7. Reducing bed rest time from five to three hours does not increase complications after cardiac catheterization: the THREE CATH Trial 1

    Science.gov (United States)

    Matte, Roselene; Hilário, Thamires de Souza; Reich, Rejane; Aliti, Graziella Badin; Rabelo-Silva, Eneida Rejane

    2016-01-01

    Abstract Objective: to compare the incidence of vascular complications in patients undergoing transfemoral cardiac catheterization with a 6F introducer sheath followed by 3-hour versus 5-hour rest. Methods: randomized clinical trial. Subjects in the intervention group (IG) ambulated 3 hours after sheath removal, versus 5 hours in the control group (CG). All patients remained in the catheterization laboratory for 5 hours and were assessed hourly, and were contacted 24, 48, and 72 h after hospital discharge. Results: the sample comprised 367 patients in the IG and 363 in the GC. During cath lab stay, hematoma was the most common complication in both groups, occurring in 12 (3%) IG and 13 (4%) CG subjects (P=0.87). Bleeding occurred in 4 (1%) IG and 6 (2%) CG subjects (P=0.51), and vasovagal reaction in 5 (1.4%) IG and 4 (1.1%) CG subjects (P=0.75). At 24-h, 48-h, and 72-h bruising was the most commonly reported complication in both groups. None of the comparisons revealed any significant between-group differences. Conclusion: the results of this trial show that reducing bed rest time to 3 hours after elective cardiac catheterization is safe and does not increase complications as compared with a 5-hour rest. ClinicalTrials.gov Identifier: NCT-01740856 PMID:27463113

  8. Transparency of outcome reporting and trial registration of randomized controlled trials in top psychosomatic and behavioral health journals: A systematic review.

    Science.gov (United States)

    Milette, Katherine; Roseman, Michelle; Thombs, Brett D

    2011-03-01

    The most reliable evidence for evaluating healthcare interventions comes from well-designed and conducted randomized controlled trials (RCTs). The extent to which published RCTs reflect the efficacy of interventions, however, depends on the completeness and accuracy of published results. The Consolidated Standards of Reporting Trials statement, initially developed in 1996, provides guidelines intended to improve the transparency of published RCT reports. A policy of the International Committee of Medical Journal Editors, initiated in 2005, requires clinical trials published in member journals to be registered in publicly accessible registries prior to patient enrollment. The objective of this study was to assess the clarity of outcome reporting, proportion of registered trials, and adequacy of outcome registration in RCTs published in top behavioral health journals. Eligible studies were primary or secondary reports of RCTs published in Annals of Behavioral Medicine, Health Psychology, Journal of Psychosomatic Research, and Psychosomatic Medicine from January 2008 to September 2009. Data were extracted for each study on adequacy of outcome reporting and registration. Of 63 articles reviewed, only 25 (39.7%) had adequately declared primary or secondary outcomes, whereas 38 (60.3%) had multiple primary outcomes or did not define outcomes. Only 13 studies (20.6%) were registered. Only 1 study registered sufficiently precise outcome information to compare with published outcomes, and registered and published outcomes were discrepant in that study. Greater attention to outcome reporting and trial registration by researchers, peer reviewers, and journal editors will increase the likelihood that effective behavioral health interventions are readily identified and made available to patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  9. Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials.

    Science.gov (United States)

    Hongell, Kira; Silva, Diego G; Ritter, Shannon; Meier, Daniela Piani; Soilu-Hänninen, Merja

    2018-02-01

    Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as 'non-users' (n = 562), 'casual users' (n = 157) and 'daily users' (usage 100% time in the study, n = 110). Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D 'daily users' versus 'non-users'. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the 'daily users'. At month 12, percent brain volume change was significantly lower in the 'daily users' versus 'non-users' and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D 'daily users' (non-significant). We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the 'daily users' of vitamin D supplement in patients in the FREEDOMS trials.

  10. Statin treatment and stroke outcome in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial

    DEFF Research Database (Denmark)

    Goldstein, L.B.; Amarenco, P.; Zivin, J.

    2009-01-01

    BACKGROUND AND PURPOSE: Laboratory experiments suggest statins reduce stroke severity and improve outcomes. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial was a placebo-controlled, randomized trial designed to determine whether treatment with atorvastatin reduces...... or 4), moderate (modified Rankin Scale score 3 or 2), and mild (modified Rankin Scale score 1 or 0) outcome ischemic strokes and transient ischemic attacks and an increase in the proportion of event-free subjects randomized to atorvastatin (P

  11. Statin therapy and clinical outcomes in myocardial infarction patients complicated by acute heart failure : insights from the EPHESUS trial

    NARCIS (Netherlands)

    Dob