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Sample records for valve implantation predictive

  1. Predictive factors for pacemaker requirement after transcatheter aortic valve implantation

    Directory of Open Access Journals (Sweden)

    Akin Ibrahim

    2012-10-01

    Full Text Available Abstract Background Transcatheter aortic valve implantation (TAVI has been established as a treatment option for inoperable patients with symptomatic aortic valve stenosis. However, patients suffer frequently from conduction disturbances after TAVI. Methods Baseline, procedural as well as surface and intracardiac ECG parameters were evaluated for patients treated with TAVI and a comparison between patients requiring pacemaker with those not suffering from relevant conduction disorders were done. Results TAVI was successfully in all patients (n=45. Baseline surface and intracardiac ECG recording revealed longer PQ (197.1±51.2 msec versus 154.1±32.1 msec; p120 msec and a PQ interval >200 msec immediately (within 60 minutes after implantation of the aortic valve were predictors for high-grade (type II second-degree and third-degree AV block. Other clinical parameters as well as baseline electrocardiographic parameters had no impact on critical conduction delay. Conclusion Cardiac conduction disturbances are common after TAVI. The need for pacing after TAVI is predictable by surface ECG evaluation immediately (within 60 minutes after the procedure.

  2. Remote actuated valve implant

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    McKnight, Timothy E; Johnson, Anthony; Moise, Jr., Kenneth J; Ericson, Milton Nance; Baba, Justin S; Wilgen, John B; Evans, III, Boyd McCutchen

    2014-02-25

    Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

  3. Remote actuated valve implant

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    McKnight, Timothy E.; Johnson, Anthony; Moise, Kenneth J.; Ericson, Milton Nance; Baba, Justin S.; Wilgen, John B.; Evans, Boyd Mccutchen

    2016-05-10

    Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

  4. Flow Test to Predict Early Hypotony and Hypertensive Phase After Ahmed Glaucoma Valve (AGV) Surgical Implantation.

    Science.gov (United States)

    Cheng, Jason; Beltran-Agullo, Laura; Buys, Yvonne M; Moss, Edward B; Gonzalez, Johanna; Trope, Graham E

    2016-06-01

    To assess the validity of a preimplantation flow test to predict early hypotony [intraocular pressure (IOP)≤5 mm Hg on 2 consecutive visits and hypertensive phase (HP) (IOP>21 mm Hg) after Ahmed Glaucoma Valve (AGV) implantation. Prospective interventional study on patients receiving an AGV. A preimplantation flow test using a gravity-driven reservoir and an open manometer was performed on all AGVs. Opening pressure (OP) and closing pressure (CP) were defined as the pressure at which fluid was seen to flow or stop flowing through the AGV, respectively. OP and CP were measured twice per AGV. Patients were followed for 12 weeks. In total, 20 eyes from 19 patients were enrolled. At 12 weeks the mean IOP decreased from 29.2±9.1 to 16.8±5.2 mm Hg (PAGV OP was 17.5±5.4 mm Hg and the mean CP was 6.7±2.3 mm Hg. Early (within 2 wk postoperative) HP occurred in 37% and hypotony in 16% of cases. An 18 mm Hg cutoff for the OP gave a sensitivity of 0.71, specificity of 0.83, positive predictive value of 0.71, and negative predictive value of 0.83 for predicting an early HP. A 7 mm Hg cutoff for the CP yielded a sensitivity of 1.0, specificity of 0.38, positive predictive value of 0.23, and negative predictive value of 1.0 for predicting hypotony. Preoperative OP and CP may predict early hypotony or HP and may be used as a guide as to which AGV valves to discard before implantation surgery.

  5. A case of SAPIEN XT valve fallen into left ventricle during valve-in-valve transcatheter aortic valve implantation.

    Science.gov (United States)

    Koizumi, Shigeki; Ehara, Natsuhiko; Nishiya, Kenta; Koyama, Tadaaki

    2017-06-24

    Late transcatheter heart valve embolization is a rare but life-threatening complication of transcatheter aortic valve implantation. Surgical intervention is performed for most cases, but some cases were treated by valve-in-valve transcatheter aortic valve implantation. We describe a patient in whom a 29-mm Edwards SAPIEN XT valve migrated into the left ventricular outflow tract 41 days after the initial implantation. We tried to perform valve-in-valve transcatheter aortic valve implantation using a transfemoral approach. As soon as the second transcatheter heart valve touched the first implanted valve, it fell into the left ventricle. Immediate surgical intervention was required. The first valve was removed, and surgical aortic valve replacement was successfully performed. In conclusion, we should choose surgical aortic valve replacement for late transcatheter heart valve embolization. Even if we need to treat by catheter intervention, transapical approach may be better.

  6. Valve thrombosis following transcatheter aortic valve implantation: a systematic review.

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    Córdoba-Soriano, Juan G; Puri, Rishi; Amat-Santos, Ignacio; Ribeiro, Henrique B; Abdul-Jawad Altisent, Omar; del Trigo, María; Paradis, Jean-Michel; Dumont, Eric; Urena, Marina; Rodés-Cabau, Josep

    2015-03-01

    Despite the rapid global uptake of transcatheter aortic valve implantation, valve trombosis has yet to be systematically evaluated in this field. The aim of this study was to determine the clinical characteristics, diagnostic criteria, and treatment outcomes of patients diagnosed with valve thrombosis following transcatheter aortic valve implantation through a systematic review of published data. Literature published between 2002 and 2012 on valve thrombosis as a complication of transcatheter aortic valve implantation was identified through a systematic electronic search. A total of 11 publications were identified, describing 16 patients (mean age, 80 [5] years, 65% men). All but 1 patient (94%) received a balloon-expandable valve. All patients received dual antiplatelet therapy immediately following the procedure and continued to take either mono- or dual antiplatelet therapy at the time of valve thrombosis diagnosis. Valve thrombosis was diagnosed at a median of 6 months post-procedure, with progressive dyspnea being the most common symptom. A significant increase in transvalvular gradient (from 10 [4] to 40 [12] mmHg) was the most common echocardiographic feature, in addition to leaflet thickening. Thrombus was not directly visualized with echocardiography. Three patients underwent valve explantation, and the remaining received warfarin, which effectively restored the mean transvalvular gradient to baseline within 2 months. Systemic embolism was not a feature of valve thrombosis post-transcatheter aortic valve implantation. Although a rare, yet likely under-reported complication of post-transcatheter aortic valve implantation, progressive dyspnea coupled with an increasing transvalvular gradient on echocardiography within the months following the intervention likely signifies valve thrombosis. While direct thrombus visualization appears difficult, prompt initiation of oral anticoagulation therapy effectively restores baseline valve function. Copyright © 2014

  7. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves

    DEFF Research Database (Denmark)

    Dvir, Danny; Webb, John G; Bleiziffer, Sabine

    2014-01-01

    IMPORTANCE: Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach......, stroke, and New York Heart Association functional class. RESULTS: Modes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation...... and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83...

  8. Transcatheter mitral valve implantation via transapical approach

    DEFF Research Database (Denmark)

    Sondergaard, Lars; Brooks, Matthew; Ihlemann, Nikolaj

    2015-01-01

    OBJECTIVES: As many as 50% of patients with severe symptomatic mitral valve regurgitation are denied surgical valve replacement or repair due to high operative risk. We describe an early series of cases of transcatheter implantation with a CardiAQ™ mitral valve via a transapical approach. METHODS...

  9. Predictive factor and clinical consequence of left bundle-branch block after a transcatheter aortic valve implantation.

    Science.gov (United States)

    Nishiyama, Takahiko; Tanosaki, Sho; Tanaka, Makoto; Yanagisawa, Ryo; Yashima, Fumiaki; Kimura, Takehiro; Arai, Takahide; Tsuruta, Hikaru; Murata, Mitsushige; Aizawa, Yoshiyasu; Kohno, Takashi; Maekawa, Yuichiro; Hayashida, Kentaro; Takatsuki, Seiji; Fukuda, Keiichi

    2017-01-15

    Atrioventricular conduction disturbances can develop after transcatherter aortic valve implantations (TAVIs) with balloon-expandable valves because the conduction system exists adjacent to the aortic valve. However, the clinical consequence of patients with new onset conduction disturbances is not clear. This study aimed to assess the incidence and progress of new-onset conduction disturbances following TAVIs and the cardiac function evaluated by echocardiography. This study consisted of 90 consecutive patients that underwent TAVIs with Edwards SAPIEN XT valves in a single center. Atrioventricular conduction system disturbances were assessed by electrocardiography and echocardiography up to 6months post TAVI. Twenty patients (22%) developed new onset complete left bundle branch block (CLBBB) or received pacemaker implantations (PMIs) during the follow-up. At 6months after the procedure, 4 patients underwent PMIs for complete AV block (CAVB), and 4 patients had persistent CLBBB. Those that developed CLBBB and AVB had a higher morbidity from hypertension and lower estimated glomerular filtration rate (eGFR). The ECG, TTE, and CT parameters did not differ between the two groups. The ratio of the valve and LVOT area was significantly associated with a higher cumulative risk of events (HR, 3.005; 95% CI, 1.034-8.736; P<0.05). Up to 20% of patients developed new CLBBB or CAVB and more than half were expected to recover. However, it required attention because approximately 40% were persistent. The ratio of the valve to LVOT area was an independent predictor. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  10. Prosthetic valve endocarditis after transcatheter aortic valve implantation

    DEFF Research Database (Denmark)

    Olsen, Niels Thue; De Backer, Ole; Thyregod, Hans G H

    2015-01-01

    BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an advancing mode of treatment for inoperable or high-risk patients with aortic stenosis. Prosthetic valve endocarditis (PVE) after TAVI is a serious complication, but only limited data exist on its incidence, outcome, and procedural...

  11. Usefulness of the CHA2DS2-VASc Score to Predict Outcome in Patients Who Underwent Transcatheter Aortic Valve Implantation.

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    Orvin, Katia; Levi, Amos; Landes, Uri; Bental, Tamir; Sagie, Alexander; Shapira, Yaron; Vaknin-Assa, Hana; Assali, Abid; Kornowski, Ran

    2017-10-19

    Risk assessment for transcatheter aortic valve implantation (TAVI) patients remains challenging, especially in elderly and high-risk candidates. Although several risk factors contribute to increased morbidity and mortality after TAVI, simple risk scores for routine use are lacking. Applying the CHA2DS2-VASC (congestive heart failure, hypertension, age ≥ 75 years, diabetes, prior stroke, vascular disease, age 65-74 years, sex [female] category) score as a novel risk stratification tool for conditions other than atrial fibrillation and stroke prevention has been previously examined; however, its usefulness in a population of patients with aortic stenosis after TAVI has not been established. Thus, we investigated 633 consecutive patients who underwent TAVI between November 2008 and May 2017, and calculated the CHA2DS2-VASC score. Patients were stratified according to their CHA2DS2-VASC score into 3 categories (0 to 3, 4 to 6, 7 to 9), and the association between CHA2DS2-VASC score and 1-year clinical outcomes (stroke, all-cause mortality, and combined outcome of stroke or mortality) was evaluated. We found that both stroke and mortality at 1 year were significantly more frequent with increasing CHA2DS2-VASC score (p = 0.012 and p = 0.025, respectively). Each single-point rise in CHA2DS2-VASC score was associated with a 38% increase in the 1-year combined outcome of mortality or stroke (p = 0.022; C index 0.615). In conclusion, CHA2DS2-VASC score can be used as a simple and effective tool to predict 1-year clinical outcomes including death and stroke in patients who underwent TAVI. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. In vitro evaluation of implantation depth in valve-in-valve using different transcatheter heart valves.

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    Simonato, Matheus; Azadani, Ali N; Webb, John; Leipsic, Jonathon; Kornowski, Ran; Vahanian, Alec; Wood, David; Piazza, Nicolo; Kodali, Susheel; Ye, Jian; Whisenant, Brian; Gaia, Diego; Aziz, Mina; Pasala, Tilak; Mehilli, Julinda; Wijeysundera, Harindra C; Tchetche, Didier; Moat, Neil; Teles, Rui; Petronio, Anna Sonia; Hildick-Smith, David; Landes, Uri; Windecker, Stephan; Arbel, Yaron; Mendiz, Oscar; Makkar, Raj; Tseng, Elaine; Dvir, Danny

    2016-09-18

    Transcatheter heart valve (THV) implantation in failed bioprosthetic valves (valve-in-valve [ViV]) offers an alternative therapy for high-risk patients. Elevated post-procedural gradients are a significant limitation of aortic ViV. Our objective was to assess the relationship between depth of implantation and haemodynamics. Commercially available THVs used for ViV were included in the analysis (CoreValve Evolut, SAPIEN XT and the Portico valve). THVs were implanted in small surgical valves (label size 19 mm) to simulate boundary conditions. Custom-mounted pulse duplicators registered relevant haemodynamic parameters. Twenty-eight experiments were performed (13 CVE, 5 SXT and 10 Portico). Ranges of depth of implantation were: CVE: -1.2 mm to 15.7 mm; SXT: -2.2 mm to 7.5 mm; Portico: 1.4 mm to 12.1 mm. Polynomial regression established a relationship between depth of implantation and valvular mean gradients (CVE: p<0.001; SXT: p=0.01; Portico: p=0.002), as well as with EOA (CVE: p<0.001; SXT: p=0.02; Portico valve: p=0.003). In addition, leaflet coaptation was better in the high implantation experiments for all valves. The current comprehensive bench testing assessment demonstrates the importance of high device position for the attainment of optimal haemodynamics during aortic ViV procedures.

  13. Sequential transcatheter aortic valve implantation due to valve dislodgement - a Portico valve implanted over a CoreValve bioprosthesis

    DEFF Research Database (Denmark)

    Campante Teles, Rui; Costa, Cátia; Almeida, Manuel

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) has become an important treatment in high surgical risk patients with severe aortic stenosis (AS), whose complications need to be managed promptly. The authors report the case of an 86-year-old woman presenting with severe symptomatic AS, rejected fo...

  14. Predictors of permanent pacemaker implantation after transfemoral aortic valve implantation with the Lotus valve.

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    Keßler, Mirjam; Gonska, Birgid; Seeger, Julia; Rottbauer, Wolfgang; Wöhrle, Jochen

    2017-10-01

    Permanent pacemaker implantation (PPMI) after transcatheter aortic valve implantation is of high clinical relevance, but PPMI rates differ widely between valve types. Although the Lotus valve can be repositioned, reported rates for PPMI are high. The predictors of PPMI after Lotus valve implantation have not been defined yet. We analyzed the impact of preexisting conduction disturbances, depth of implantation, oversizing, and amount of calcification on PPMI in 216 patients with severe symptomatic aortic stenosis underdoing Lotus valve implantation. PPMI was required in 39.8% of patients. Patients with need for PPMI compared with patients without need for PPMI had more often the following criteria: male gender (P=.035); preprocedural right bundle-branch block (RBBB) (16.3% vs 0, P<.001); atrioventricular (AV) block first degree (26.7% vs 10.1%, P=.004); higher calcium volume of the left coronary cusp (63.1±87.5 mm(3) vs 42.8±49.3 mm(3), P=.05); and deeper valve implantation at right coronary (P=.011), noncoronary (P=.026), and left coronary (P=.012) position. Oversizing in relation to annulus and left ventricular outflow tract did not have an impact on need for PPMI. By multiple regression analysis, preprocedural AV block first degree (P=.005), RBBB (P<.001), and depth of implantation (P=.006) were independent risk factors for need of PPMI. In patients with severe aortic stenosis receiving transfemoral Lotus valve, preexisting AV block first degree, RBBB, and implantation depth are independent predictors of PPMI, highlighting the importance of careful valve positioning. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Autopsy after transcatheter aortic valve implantation

    DEFF Research Database (Denmark)

    van Kesteren, F; Wiegerinck, E M A; Rizzo, S

    2017-01-01

    Autopsy after transcatheter aortic valve implantation (TAVI) is a new field of interest in cardiovascular pathology. To identify the cause of death, it is important to be familiar with specific findings related to the time interval between the procedure and death. We aimed to provide an overview ...

  16. Norton scale for predicting prognosis in elderly patients undergoing trans-catheter aortic valve implantation: A historical prospective study.

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    Rabinovitz, Edith; Finkelstein, Ariel; Ben Assa, Eyal; Steinvil, Arie; Konigstein, Maayan; Shacham, Yacov; Yankelson, Lior; Banai, Shmuel; Justo, Dan; Leshem-Rubinow, Eran

    2016-06-01

    The Norton scale is traditionally used to assess the risk of pressure ulcers. However, recent studies have shown its prognostic utilization in elderly patients with diverse medical conditions. The association between low admission Norton scale scores (ANSS), complications, and mortality in elderly patients following trans-catheter aortic valve implantation (TAVI) has never been studied. We aimed to determine if low ANSS (≤16) is associated with complications and 30-day and 1-year mortality in elderly patients undergoing TAVI. The medical charts of elderly (≥70 years) TAVI patients at the Tel-Aviv Medical Center, a tertiary medical center, were studied for the following measurements: ANSS, demographics, co-morbidities, complications during hospitalization, and 30-day and 1-year mortality. Complications included: an atrio-ventricular block, stroke, and vascular complications. The cohort included 302 elderly patients: 179 (59.3%) were women; the mean age was 83.3±5.1 years. Following TAVI, 112 (37.1%) patients had complications other than pressure ulcers, 10 (3.3%) patients died within 30 days, and 42 (13.9%) patients died within one year. Overall, 36 (11.9%) patients had low ANSS. 1-year mortality rates were almost three times higher in patients with low ANSS relative to patients with high ANSS (27.8% vs. 12.0%; the relative risk 1.1; p=0.018). A stepwise logistic regression analysis showed that ANSS was independently inversely associated with 1-year mortality (p=0.018). Complications and 30-day mortality rates were similar in both groups. Low ANSS are associated with 1-year mortality after TAVI. The Norton scale may therefore be used as an additional tool for elderly patient selection before TAVI. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  17. Early experience with the Venus p‑valve for percutaneous pulmonary valve implantation in native outflow tract.

    Science.gov (United States)

    Garay, F; Pan, X; Zhang, Y J; Wang, C; Springmuller, D

    2017-02-01

    The Venus p‑valve (MedTech, Shanghai, China) is a self-expanding percutaneous heart valve designed to be implanted in a native patched right ventricle outflow tract. The worldwide clinical experience with this valve is just beginning and the results have so far been encouraging. We present our initial early experience implanting the Venus p‑valve in the native right ventricle outflow tract of patients with Tetralogy of Fallot repaired with a transannular patch. In 10 selected patients a procedure for percutaneous pulmonary valve implantation was performed using the Venus p‑valve. The patients mean age was 32 years (13-57), mean weight 59.6 kg (40-80). All patients had Tetralogy of Fallot with moderate to severe pulmonary regurgitation and an indication for pulmonary valve replacement. The implantation procedure was successful in all the patients resulting in an immediately functional valve. No procedure-related complications were observed. Follow-up after 12 months (4-21) resulted in an improvement in NYHA class. There was a reduction of the mean right ventricle diastolic volume from 139 ml/m2 (105-179) to 78 ml/m2 (65-100) and improvement in the regurgitation fraction from 42% (29-58) to 1% (0-5), as seen on routine cardiac magnetic resonance 6 months after the implantation. No stent fractures have been observed so far. Percutaneous pulmonary valve implantation with the Venus p‑valve resulted in a safe and effective procedure. The valve has predictable and sustained functional competence, resulting in clinical improvement in the patients.

  18. THE PROGNOSIS IN TRANSCATHETER AORTIC VALVE IMPLANTATION

    Directory of Open Access Journals (Sweden)

    T. E. Imaev

    2016-01-01

    Full Text Available Aim. To study the effect of transcatheter aortic valve implantation (TAVI, performed by different types of prostheses and various surgical access, on the prognosis of patients with critical aortic stenosis and comorbidities.Material and methods. Patients (n=130 that had consistently performed 80 TAVI by Edwards valve transfemoral (n=50 and transapical (n=30 access, as well as 50 transcatheter aortic valve replacement by CoreValve system were included into the study. Complications including perioperative mortality, total 30-day mortality, as well as post-hospital mortality were registered during aortic valve replacement, immediately after surgery, before the expiry of 30 days. Mean follow-up was 2.2 years (range 0.2 to 5.2 years.Results. Hospital mortality was on average 6.9%. 121 patients had been discharged from the department after the surgery. The number of deaths in the post-hospital period was 14.8%. Valve type and the type of access had no effect on post-hospital mortality. Men died more than 2.5 times often than women, regardless of age. Atrioventricular block, pacemaker implantation, and history of chronic obstructive pulmonary disease were the most significant prognostic factors. An important role of minor stroke and renal failure should be noted. Mortality did not depend on the surgical access or valve type. All parameters characterizing the intervention were significantly associated with mortality, both during and after surgery. The proportion of survivors at the end of the first year of observation using Corvalve system was 86.9%, Edwards valve by transfemoral access - 88% and Edwards valve by transapical access – 85.4% (insignificant differences for all groups, p>0.05. Two-year survival was 77.5%, 82.5% and 82.7%, respectively (also insignificant differences for all groups, p>0.05.Conclusion. TAVI is the method of choice, reasonable alternative approach for surgical valve replacement in patients with high surgical risk, although

  19. Transcatheter aortic valve implantation and cerebrovascular accidents.

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    Stortecky, Stefan; Wenaweser, Peter; Windecker, Stephan

    2012-09-01

    Transcatheter aortic valve implantation (TAVI) is an evidence-based treatment alternative for selected high-risk patients with symptomatic severe aortic stenosis as acknowledged in the most recent edition of the ESC Guidelines on Valvular Heart Disease 2012. However, periprocedural complications and in particular cerebrovascular accidents remain a matter of concern. While transcatheter heart valve technology continuously improves and the development of novel and even less invasive implantation techniques is on-going, cerebrovascular events complicating TAVI may abrogate the usual improvement in terms of prognosis and quality of life. This article describes the incidence of cerebrovascular events after cardiovascular procedures, provides an overview of the pathophysiological mechanisms as well as the impact on outcomes and provides some insights into preventive strategies as well as the acute management of these events.

  20. Transcatheter valve-in-valve implantation due to severe aortic regurgitation in a degenerated aortic homograft

    DEFF Research Database (Denmark)

    Olsen, Lene Kjaer; Engstrøm, Thomas; Søndergaard, Lars

    2009-01-01

    a successful valve-in-valve implantation of a CoreValve aortic valve prosthesis through the right subclavian artery in a case of severe aortic regurgitation within a degenerated aortic homograft. The case exemplifies the possibilities of expanding the indications for TAVI, as well as other vascular access...

  1. Superior versus inferior Ahmed glaucoma valve implantation.

    Science.gov (United States)

    Pakravan, Mohammad; Yazdani, Shahin; Shahabi, Camelia; Yaseri, Mehdi

    2009-02-01

    To compare the efficacy and safety of Ahmed glaucoma valve (AGV) (New World Medical Inc., Rancho Cucamonga, CA) implantation in the superior versus inferior quadrants. Prospective parallel cohort study. A total of 106 eyes of 106 patients with refractory glaucoma. Consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included intraocular pressure (IOP) and rate of complications. Other outcome measures included best corrected visual acuity (BCVA), number of glaucoma medications, and success rate (defined as at least 30% IOP reduction and 5AGV implantation in the superior and inferior quadrants, respectively. Baseline characteristics were comparable in the study groups, except for preoperative IOP, which was higher in the superior group (P = 0.01). Patients were followed for a mean period of 10.6+/-8.49 months and 10.58+/-6.75 months in the superior and inferior groups, respectively (P = 0.477). BCVA was comparable between the groups at all postoperative visits (P>0.122). After 1 year, statistically significant but comparable IOP reduction from baseline (PAGV implants have similar intermediate efficacy in terms of IOP reduction, decrease in number of glaucoma medications, and preservation of vision. However, the inferior quadrants entail significantly more complications. It may be prudent to avoid AGV implantation in the inferior quadrants if the superior quadrants have no contraindications to surgery. Proprietary or commercial disclosure may be found after the references.

  2. Pregnancy After Transcatheter Pulmonary Valve Implantation.

    Science.gov (United States)

    Kozicka, Urszula; Weroński, Krzysztof; Rużyłło, Witold; Demkow, Marcin; Kowalski, Mirosław; Śpiewak, Mateusz; Piotrowicz, Ewa; Siudalska, Hanna; Hoffman, Piotr; Biernacka, Elżbieta K

    2017-12-01

    Transcatheter pulmonary valve implantation (TPVI) is a relatively new method of treating patients with significant pulmonary regurgitation or pulmonary stenosis, or both, after reconstruction of the right ventricular outflow tract. It is an attractive alternative to conduit replacement in this group of patients, who are typically young and active. This report includes 4 young women who after successful TPVI became pregnant and gave birth. Transthoracic echocardiography, cardiopulmonary exercise testing, and cardiac magnetic resonance imaging were performed in all patients. The results suggest that pregnancy and delivery after successful TPVI is safe when the appropriate precautions have been taken. Copyright © 2017 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  3. Immunological aspects of clinical and experimental cardiac valve allograft implantation

    NARCIS (Netherlands)

    F.B.S. Oei (Frank)

    2001-01-01

    textabstractThe documented history of allogeneic cardiac valve implantation began in 1952. In that year, the first successful implantation of an canine aortic valve in the descendlng aorta of another dog, was carried out by Conrad Lam etal. Driven by the succes seen in this animal model Murray et

  4. Glaucoma valve implants in Nigerians a report of early experience ...

    African Journals Online (AJOL)

    Objective: To show the value of glaucoma valve implant surgery in the management of glaucoma in Nigerians. Design: A prospective study of two glaucoma patients who had an Ahmed glaucoma valve implant at the University of Benin Teaching Hospital and DDS Eye Surgery in Benin City. Materials and method: One ...

  5. Transcatheter aortic valve implantation for bicuspid aortic valve stenosis.

    Science.gov (United States)

    Hamdan, Ashraf; Kornowski, Ran

    2015-08-01

    In Preprocedural CT, patients with BAV have larger aortic annulus perimeters, and more calcified valves compared with TAV. In patients with BAV, self-expandable valves were under-expand and balloon-expandable valves have a trend toward increased rates of postimplantation AR grade. Self-expandable valves have higher postprocedural gradient in BAV compared with TAV. © 2015 Wiley Periodicals, Inc.

  6. Transcatheter aortic valve implantation with balloonexpandable valve: early experience from China

    Directory of Open Access Journals (Sweden)

    Qingsheng Lu

    2015-08-01

    Full Text Available Abstract Objective: The aim of the current study was to evaluate the early experience of the application of transcatheter aortic valve implantation with the balloon-expandable system in China. The transcatheter aortic valve implantation technology has been widely used for patients with inoperable severe aortic stenosis in the developed world. The application of transcatheter aortic valve implantation is still in the early stages of testing in China, particularly for the balloon-expandable valve procedure. Methods: This was a retrospective study. All patients undergoing transcatheter aortic valve implantation with balloon-expandable system in our hospital between 2011 and 2014 were included. Edwards SAPIEN XT Transcatheter Heart Valve was used. The improvement of valve and heart function was evaluated as well as 30-day mortality and major complications according to the VARC-2 definition. Results: A total of 10 transcatheter aortic valve implantation procedures with the balloon-expandable system were performed in our hospital, of which 9 were transfemoral and 1 was transapical. The median age was 76 years, and the median STS score and Logistic EuroSCORE (% were 8.9 and 16.2. The implantation was successfully conducted in all patients, only 2 patients had mild paravalvular leak. There was no second valve implantation. Moreover, no 30-day mortality or complications was reported. Following the transcatheter aortic valve implantation procedure, the heart and valve functions had improved significantly. During the follow-up period of 3-34 months, one patient died of lung cancer 13 months after the operation. Conclusion: This early experience has provided preliminary evidence for the safety and efficacy of transcatheter aortic valve implantation procedure with the balloon-expandable system in the developing world with an increasing aging population.

  7. Simplified surgical-hybrid Melody® valve implantation for paediatric mitral valve disease

    OpenAIRE

    Hofmann, Michael; Dave, Hitendu; Hübler, Michael; Kretschmar, Oliver

    2017-01-01

    Children suffering from left atrioventricular valve (LAVV) disease not amenable to repair represent a significant challenge. The results of surgical reconstruction are not optimal. Valve replacement as an alternative is associated with poor results. The surgical-hybrid approach with implantation of a stented biological valve (bovine jugular vein graft, Melody® valve) seems to represent a new therapeutic option. Here we demonstrate our case, the consideration and the approach to extreme clinic...

  8. Absorbable Implant to Treat Nasal Valve Collapse.

    Science.gov (United States)

    San Nicoló, Marion; Stelter, Klaus; Sadick, Haneen; Bas, Murat; Berghaus, Alexander

    2017-04-01

    Objective To evaluate the safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with nasal valve collapse (NVC) with 12 months follow-up. Methods Thirty subjects with Nasal Obstruction Symptom Evaluation (NOSE) score ≥ 55 and isolated NVC were treated; 14 cases were performed in an operating suite under general anesthesia and 16 cases were performed in a clinic-based setting under local anesthesia. The implant, a polylactic acid copolymer, was placed with a delivery tool within the nasal wall to provide lateral cartilage support. Subjects were followed up through 12 months postprocedure. Results Fifty-six implants were placed in 30 subjects. The mean preoperative NOSE score was 76.7 ± 14.8, with a range of 55 to 100. At 12 months, the mean score was 35.2 ± 29.2, reflecting an average within-patient reduction of -40.9 ± 31.2 points. The majority (76%) of the subjects were responders defined as having at least one NOSE class improvement or a NOSE score reduction of at least 20%. There were no adverse changes in cosmetic appearance at 12 months postprocedure. Three implants in three subjects required retrieval within 30 days postprocedure and resulted in no clinical sequelae. Conclusion This study demonstrates safety and effectiveness of an absorbable implant for lateral cartilage support in subjects with NVC at 12 months postprocedure. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  9. Transcatheter, valve-in-valve transapical aortic and mitral valve implantation, in a high risk patient with aortic and mitral prosthetic valve stenoses

    Directory of Open Access Journals (Sweden)

    Harish Ramakrishna

    2015-01-01

    Full Text Available Transcatheter valve implantation continues to grow worldwide and has been used principally for the nonsurgical management of native aortic valvular disease-as a potentially less invasive method of valve replacement in high-risk and inoperable patients with severe aortic valve stenosis. Given the burden of valvular heart disease in the general population and the increasing numbers of patients who have had previous valve operations, we are now seeing a growing number of high-risk patients presenting with prosthetic valve stenosis, who are not potential surgical candidates. For this high-risk subset transcatheter valve delivery may be the only option. Here, we present an inoperable patient with severe, prosthetic valve aortic and mitral stenosis who was successfully treated with a trans catheter based approach, with a valve-in-valve implantation procedure of both aortic and mitral valves.

  10. A Hybrid Double Access for Transcatheter Mitral Valve-In-Valve Implantation.

    Science.gov (United States)

    Pagnotta, Paolo; Mennuni, Marco G; Ferrante, Giuseppe; Ornaghi, Diego; Bragato, Renato; Cappai, Antioco; Presbitero, Patrizia

    2015-06-01

    We present a case of hybrid mitral valve-in valve implantation. The planned transapical approach failed due to the inability to cross the degenerated stenotic mitral bioprosthesis. An alternative strategy was performed: first, an anterograde crossing of mitral stenosis, and then, a guidewire externalization through the apex by using a snare. To our knowledge, this is the first described case of double approach mitral valve-in valve implantation. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  11. Full metal jacket: transfemoral aortic valve implantation for regurgitant valve after endovascular aortic repair†.

    Science.gov (United States)

    Tanyeli, Omer; Dereli, Yuksel; Gormus, Niyazi; Duzenli, Mehmet Akif

    2017-07-25

    Transfemoral aortic valve implantation has become an almost routine interventional procedure for severe aortic stenosis in high-risk patients. Over time an increased number of experiences has led to unusual procedures. In this report, we present a successful valve-in-valve transfemoral aortic valve implantation in a patient with aortic regurgitation, who previously had debranching and thoracic endovascular aortic repair operations. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  12. Simplified surgical-hybrid Melody valve implantation for paediatric mitral valve disease.

    Science.gov (United States)

    Hofmann, Michael; Dave, Hitendu; Hübler, Michael; Kretschmar, Oliver

    2015-05-01

    Children suffering from left atrioventricular valve (LAVV) disease not amenable to repair represent a significant challenge. The results of surgical reconstruction are not optimal. Valve replacement as an alternative is associated with poor results. The surgical-hybrid approach with implantation of a stented biological valve (bovine jugular vein graft, Melody valve) seems to represent a new therapeutic option. Here we demonstrate our case, the consideration and the approach to extreme clinical findings in a small child. We describe a simplified surgical-hybrid Melody valve implantation in a LAVV position. The technique of implantation is relatively simple and the immediate postoperative result very good. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  13. Preparatory balloon aortic valvuloplasty during transcatheter aortic valve implantation for improved valve sizing.

    Science.gov (United States)

    Patsalis, Polykarpos C; Al-Rashid, Fadi; Neumann, Till; Plicht, Björn; Hildebrandt, Heike A; Wendt, Daniel; Thielmann, Matthias; Jakob, Heinz G; Heusch, Gerd; Erbel, Raimund; Kahlert, Philipp

    2013-09-01

    This study sought to evaluate whether supra-aortic angiography during preparatory balloon aortic valvuloplasty (BAV) improves valve sizing. Current recommendations for valve size selection are based on annular measurements by transesophageal echocardiography and computed tomography, but paravalvular aortic regurgitation (PAR) is a frequent problem. Data of 270 consecutive patients with either conventional sizing (group 1, n = 167) or balloon aortic valvuloplasty-based sizing (group 2, n = 103) were compared. PAR was graded angiographically and quantitatively using several hemodynamic indices. PAR was observed in 113 patients of group 1 and 41 patients of group 2 (67.7% vs. 39.8%, p < 0.001). More than mild PAR was found in 24 (14.4%) patients of group 1 and 8 (7.8%) patients of group 2. According to pre-interventional imaging, 40 (39%) patients had a borderline annulus size, raising uncertainty regarding valve size selection. Balloon sizing resulted in selection of the bigger prosthesis in 30 (29%) and the smaller prosthesis in the remaining patients, and only 1 of these 40 patients had more than mild PAR. As predicted by the hemodynamic indices of PAR, mortality at 30 days and 1 year was less in group 2 than in group 1 (5.8% vs. 9%, p = 0.2 and 10.6% vs. 20%, p = 0.01). Preparatory balloon aortic valvuloplasty during transcatheter aortic valve implantation improves valve size selection, reduces the associated PAR, and increases survival in borderline cases. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. Perceval S aortic valve implantation in an achondroplastic Dwarf

    Directory of Open Access Journals (Sweden)

    Nikolaos G Baikoussis

    2016-01-01

    Full Text Available Despite cardiovascular disease in patients with dwarfism is not rare; there is a lack of reports referring to cardiac interventions in such patients. Dwarfism may be due to achondroplasia or hormonal growth disorders. We present a 58-year-old woman with episodes of dyspnea for several months. She underwent on transthoracic echocardiography, and she diagnosed with severe aortic valve stenosis. She referred to our department for surgical treatment of this finding. In accordance of her anthropometric characteristics and her very small aortic annulus, we had the dilemma of prosthesis selection. We decided to implant a stentless valve to optimize her effective orifice area. Our aim is to present the successful Perceval S valve implantation and the descriptions of the problems coming across in operating on these special patients. To our knowledge, this is the first case patient in which a Perceval S valve is implanted according to the international bibliography.

  15. Comparative Matched Outcome of Evolut-R vs CoreValve Transcatheter Aortic Valve Implantation.

    Science.gov (United States)

    Landes, Uri; Bental, Tamir; Barsheshet, Alon; Assali, Abid; Vaknin Assa, Hana; Levi, Amos; Orvin, Katia; Kornowski, Ran

    2017-02-01

    The Evolut-R (Medtronic, Inc) is a transcatheter aortic valve implantation (TAVI) system that was built on the well-established foundation of Medtronic's CoreValve device platform. Although already in extensive clinical utilization, it is unknown if the Evolut-R improves TAVI outcomes. Herein, we compared TAVI outcomes of the Evolut-R and CoreValve devices. A propensity score 1:1 matching was conducted on 358 Evolut-R patients (n = 75) and CoreValve patients (n = 283). Thirty-day outcomes were compared using Valve Academic Research Consortium (VARC)-2 criteria. A combined 30-day endpoint including all-cause death, stroke, major vascular complication, major bleeding, implantation failure, paravalvular leak (PVL) ≥ moderate, and new pacemaker implantation was also tested. The final study group included 146 patients (73 Evolut-R; 73 CoreValve). Post matching, baseline characteristics were similar between the two groups. Mean patient age was 82 ± 6 years, mean STS score was 5.2 ± 3.8, 72% were female, and 17% were deemed frail. Implantation success reached 99% with Evolut-R and 94% with CoreValve (P=.10). Both groups had low periprocedural stroke/myocardial infarction/mortality rates and there was also no difference in 30-day vascular complications (P=.18), bleeding (P=.37), PVL (P=.24), and new pacemaker (P=.14). The combined outcome rate was 24% with Evolut-R and 37% with CoreValve (P=.10). This study indicates that the efficacy and safety of the self-expandable second-generation Evolut-R transcatheter valve is at least comparable with the first-generation CoreValve. The observed improved performance in correct positioning of a single valve and the numerically lower chance to suffer a combined TAVI endpoint needs further investigation.

  16. Safety considerations during transapical aortic valve implantation.

    Science.gov (United States)

    Drews, Thorsten; Pasic, Miralem; Juran, Ralf; Unbehaun, Axel; Dreysse, Stephan; Kukucka, Marian; Mladenow, Alexander; Hetzer, Roland; Buz, Semih

    2014-05-01

    Transcatheter aortic valve implantation (TAVI) is a new method for the treatment of very high-risk patients with aortic valve stenosis. The radiation dose to which the patient and each member of the heart team are exposed during this new fluoroscopically guided intervention is unknown. Between April 2008 and August 2013, 1177 consecutive patients underwent transapical TAVI (TA-TAVI). In 22 consecutive patients undergoing TA-TAVI, the radiation doses to the cardiothoracic surgeon, cardiologist, anaesthesiologist (performing echocardiography examination), surgical assistant and nurse were measured. The radiation dose measurements were performed during TAVI using thermoluminescence and film dosimeters positioned on seven parts of the body: (i) chest above the lead apron, (ii) pelvic area below the apron, (iii) chest below the apron, (iv) thyroid gland above the apron, (v) near eyes, (vi) hands (using rings) and (vii) the feet. The results were compared with the values given in the international literature on recommended radiation dose limits for workers. The mean radiation time was 6.1 min and the mean dose-area product for the patients was 8.661 µGy · m(2). Analysis of the dosimeters and the calculation of the effective dose showed a per intervention dose of 0.03 mSv for the surgeon, 0.05 mSv for the assistant, 0.02 mSv for the cardiologist and the anaesthesiologist and 0.001 mSv for the nurse. The maximum ionizing radiation per intervention was 0.5 mSv at the right hand of the surgeon (holding the introducer sheet) and 0.7 mSv at the left hand of the surgical assistant. Additionally, the analysis of the body dose shows a maximum dose to the lower leg of the surgeon (0.3 mSv) and the genital area of the assistant (0.06 mSv). During a TA-TAVI procedure, the patients receive a higher X-ray dose than during coronary angiography with intervention. After 100 TAVI procedures, the members of the heart team sustain a comparable dose of ionizing radiation to the annual dose

  17. Transcatheter aortic valve-in-valve implantation of a CoreValve in a JenaValve prosthesis: a case report.

    Science.gov (United States)

    Lotfi, Shahram; Becker, Michael; Moza, Ajay; Autschbach, Rüdiger; Marx, Nikolaus; Schröder, Jörg

    2017-09-10

    Transcatheter aortic valve implantation has become an accepted treatment modality for inoperable or high-risk surgical patients with symptomatic severe aortic stenosis. We report the case of a 70-year-old white man who was treated for severe symptomatic aortic regurgitation using transcatheter aortic valve implantation from the apical approach. Because of recurrent cardiac decompensation 4 weeks after implantation he underwent the implantation of a left ventricular assist device system. A year later echocardiography showed a severe transvalvular central insufficiency. Our heart team decided to choose a valve-in-valve approach while reducing the flow rate of left ventricular assist device to minimum and pacing with a frequency of 140 beats/minute. There was an excellent result and our patient is doing well with no relevant insufficiency of the aortic valve at 12-month follow-up. This is the first report about a successful treatment of a stenotic JenaValve using a CoreValve Evolut R; the use of a CoreValve Evolut R prosthesis may be an optimal option for valve-in-valve procedures.

  18. Successful treatment of annular rupture during transcatheter aortic valve implantation.

    Science.gov (United States)

    Unic, Daniel; Sutlic, Zeljko; Starcevic, Boris; Bradic, Nikola; Baric, Davor; Rudez, Igor

    2017-04-01

    Annular rupture presents a rare but potentially fatal complication of transcatheter aortic valve implantation (TAVI). Although it can be subtle and subclinical in presentation, most severe forms present with hemodynamic instability and represent true emergencies requiring a more invasive treatment, even conventional surgery. We present a case of successful treatment of annular rupture by left ventricular outflow tract patch and surgical aortic valve replacement.

  19. Ahmed glaucoma valve implant: surgical technique and complications

    Directory of Open Access Journals (Sweden)

    Riva I

    2017-02-01

    Full Text Available Ivano Riva,1 Gloria Roberti,1 Francesco Oddone,1 Anastasios GP Konstas,2 Luciano Quaranta3 1IRCCS “Fondazione GB Bietti per l’Oftalmologia”, Rome, Italy; 21st University Department of Ophthalmology, Glaucoma Unit, AHEPA Hospital, Thessaloniki, Greece; 3Department of Medical and Surgical Specialties, Section of Ophthalmology, University of Brescia, Brescia, Italy Abstract: Implantation of Ahmed glaucoma valve is an effective surgical technique to reduce intraocular pressure in patients affected with glaucoma. While in the past, the use of this device was reserved to glaucoma refractory to multiple filtration surgical procedures, up-to-date mounting experience has encouraged its use also as a primary surgery for selected cases. Implantation of Ahmed glaucoma valve can be challenging for the surgeon, especially in patients who already underwent previous multiple surgeries. Several tips have to be acquired by the surgeon, and a long learning curve is always needed. Although the valve mechanism embedded in the Ahmed glaucoma valve decreases the risk of postoperative hypotony-related complications, it does not avoid the need of a careful follow-up. Complications related to this type of surgery include early and late postoperative hypotony, excessive capsule fibrosis around the plate, erosion of the tube or plate edge, and very rarely infection. The aim of this review is to describe surgical technique for Ahmed glaucoma valve implantation and to report related complications. Keywords: glaucoma, surgical technique, glaucoma drainage devices, Ahmed glaucoma valve, complications

  20. Ahmed glaucoma valve implant: surgical technique and complications.

    Science.gov (United States)

    Riva, Ivano; Roberti, Gloria; Oddone, Francesco; Konstas, Anastasios Gp; Quaranta, Luciano

    2017-01-01

    Implantation of Ahmed glaucoma valve is an effective surgical technique to reduce intraocular pressure in patients affected with glaucoma. While in the past, the use of this device was reserved to glaucoma refractory to multiple filtration surgical procedures, up-to-date mounting experience has encouraged its use also as a primary surgery for selected cases. Implantation of Ahmed glaucoma valve can be challenging for the surgeon, especially in patients who already underwent previous multiple surgeries. Several tips have to be acquired by the surgeon, and a long learning curve is always needed. Although the valve mechanism embedded in the Ahmed glaucoma valve decreases the risk of postoperative hypotony-related complications, it does not avoid the need of a careful follow-up. Complications related to this type of surgery include early and late postoperative hypotony, excessive capsule fibrosis around the plate, erosion of the tube or plate edge, and very rarely infection. The aim of this review is to describe surgical technique for Ahmed glaucoma valve implantation and to report related complications.

  1. Antithrombotic therapy after bioprosthetic aortic valve implantation

    DEFF Research Database (Denmark)

    Rafiq, Sulman; Steinbrüchel, Daniel Andreas; Lilleør, Nikolaj Bang

    2017-01-01

    Background The optimal medical strategy for prevention of thromboembolic events after surgical bioprosthetic aortic valve replacement (BAVR) is still debated. The objective of this study was to compare warfarin therapy (target INR of 2.0 to 3.0) with aspirin 150 mg daily as antithrombotic therapy...

  2. Explantation of the novel Ahmed glaucoma valve M4 implant.

    Science.gov (United States)

    Hu, Wanda D; Pro, Michael J; Fudemberg, Scott J; Moster, Marlene R

    2015-02-01

    To report a series of cases involving Ahmed Glaucoma Valve M4 (AGV) explantation and to discuss the surgical technique to remove the drainage device. Four cases were identified that presented with AGV M4 postoperative complications necessitating tube shunt removal. Three patients presented with conjunctival erosion and 1 patient with persistent diplopia. AGV M4 implants were removed successfully between 1.5 and 9 months after implantation. Successful explantation of the AGV M4 novel implant was achieved in all cases without intraoperative or postoperative complications. If necessary, AGV M4 explantation can be successfully performed in the early postoperative period.

  3. Percutaneous transfemoral-transseptal implantation of a second-generation CardiAQ™ mitral valve bioprosthesis

    DEFF Research Database (Denmark)

    Ussia, Gian Paolo; Quadri, Arshad; Cammalleri, Valeria

    2016-01-01

    AIMS: Transcatheter mitral valve implantation for mitral valve regurgitation is in the very early phase of development because of challenging anatomy and device dimensions. We describe the procedure of a transfemoral-transseptal implantation of the second-generation CardiAQ mitral valve bioprosth....... CONCLUSIONS: This procedure shows that percutaneous transfemoral transcatheter mitral valve implantation is feasible, safe and successful. Further experience is needed to render this procedure clinically available....

  4. Update on the need for a permanent pacemaker after transcatheter aortic valve implantation using the CoreValve® Accutrak™ system.

    Science.gov (United States)

    Tchetche, Didier; Modine, Thomas; Farah, Bruno; Vahdat, Olivier; Sudre, Arnaud; Koussa, Mohamad; Lereun, Corinne; Nejjari, Mohammed; Choby, Michael; Rosencher, Julien; Sorbets, Emmanuel; Fajadet, Jean

    2012-09-01

    High rates of permanent pacemaker (PPM) implantation are reported after transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve® system. The Accutrak™ catheter is designed to allow a more predictable landing zone. Little is known about the real clinical impact of this catheter. The aims of this paper were to describe the potential impact of the Accutrak™ catheter on the accuracy of positioning a 26 or 29 mm CoreValve® across the aortic annulus and its impact on the need for a pacemaker. A total of 134 patients were treated with the CoreValve® Accutrak™ system at two French centres (Lille and Toulouse). Mean age was 82.4 ± 4.7 years; logistic EuroSCORE was 24.3 ± 9.5%. Procedural success rate was 99.2%; mean depth of implantation was 4.9 mm. A final position between 0 and 6 mm was achieved in 85.8% of the patients. All-cause mortality at 30 days was 6%. The PPM implantation rate was 10.6%. Due to a limited number of events, we could not identify any predictor of need for a PPM: pre-existing right bundle branch block (RBBB) (OR 2.72 [0.63-11.87], p=ns), use of a 29 mm prosthesis (OR 2.73 [0.33-22.90], p=ns) and left ventricular septal hypertrophy (OR 2.63 [0.08-83.32], p=ns). In this cohort of patients treated with the CoreValve® Accutrak™ system, the incidence of permanent pacemaker implantation was low, which may be a consequence of an average small implantation depth. The Accutrak™ catheter seems to be helpful in achieving higher and more predictable implants. Operators could standardise their technique to place the CoreValve® prostheses less than 6 mm below the aortic annulus.

  5. Experimental substantiation of the design of a prosthetic heart valve for «valve-in-valve» implantation

    Directory of Open Access Journals (Sweden)

    K. Yu. Klyshnikov

    2017-01-01

    Full Text Available The aim of the study was to perform a series of in vitro tests of a prototype of the developing heart valve prosthesis to evaluate its functional characteristics. Materials and methods. In this work we have used the frames and full prototypes of the prosthesis, consisting of a stent-like stainless steel support frame with mounted biological leaflets and cover. The authors evaluated the calculated and experimental forces necessary for the displacement of the sutureless implanted prosthesis using the test machine under uniaxial tension. The risk of defects and damages to the supporting framework as a result of implantation was evaluated by scanning electron microscopy. The hydrodynamic characteristics of the prosthesis were investigated under physiological conditions and «valvein-valve» implantation. Evaluation of the ergonomics and applicability of the proposed construction on the cadaver heart model of cattle was carried out. Results. As a result of the forces assessment, it was found that the force required to shear the prosthesis was 3.12 ± 0.37 N, while the calculated value was 1.7 N, which is significantly lower than the obtained value. The comparison of the images obtained with small and large magnifications demonstrated the absence of critical surface defects. Additional analysis under the super-large magnifications also did not reveal problem areas. During the hydrodynamic study, it was shown that the average transplant gradient increased slightly from 2.8–3.4 to 3.2–4.5 mm Hg for the initial prosthesis and the «valve-in-valve» complex, respectively. The decrease of the effective orifice area was 6–9% relative to the initial one. Evaluation of the implantation technique demonstrated the consistency of the approach: the use of the developed holder in combination with the balloon implantation system made it possible to position the prosthesis throughout the procedure. Conclusion. The series of tests demonstrates the consistency

  6. [Transcatheter aortic valve implantation (TAVI): update on the indications].

    Science.gov (United States)

    Fournier, Stéphane; Monney, Pierre; Ferrari, Enrico; Iglesias, Juan F; Roguelov, Christan; Zuffi, Andrea; Eeckhout, Eric; Muller, Olivier

    2015-05-27

    Although surgical aortic valve replacement has been the standard of care for patient with severe aortic stenosis, transcatheter aortic valve implantation (TAVI) is now a fair standard of care for patients not eligible or high risk for surgical treatment. The decision of therapeutic choice between TAVI and surgery considers surgical risk (estimated by the Euro-SCORE and STS-PROM) as well as many parameters that go beyond the assessment of the valvular disease's severity by echocardiography: a multidisciplinary assessment in "Heart Team" is needed to assess each case in all its complexity.

  7. Effect of Ahmed valve implantation on late neovascular glaucoma

    Directory of Open Access Journals (Sweden)

    Ping-An Mao

    2013-09-01

    Full Text Available AIM: To discuss the effect and safety of Ahmed valve implantation in late neovascular glaucoma. METHODS: The Ahmed glaucoma valve were implanted in 41 eyes(41 caseswith late neovascular glaucoma, the follow-up was 12 months on average, intraocular pressure was recorded at 1 day, 1 week, 1 month, 3, 6, 12 months respectively after operation and compared with that before operation, at the same time, the complications and treatment were analyzed.RESULTS: The mean intraocular pressure before operation, 1 day, 1 week, 1 month, 3, 6, 12 months after operation was 59.83±5.53, 19.27±8.19, 19.69±6.86, 20.67±6.73, 21.05±6.93, 21.49±7.42, 22.14±8.08mmHg, the mean intraocular pressure before operation was higher than that after operation and the difference was obvious in statistics. Major complications included hyphema, low intraocular pressure early postoperation, shallow anterior chamber, obstruction of the tube, the plate wrapped or exposed.CONCLUSION: Ahmed valve implantation is an effective method to treatlate neovascular glaucoma.

  8. Use of a novel hybrid approach to salvage an attempted transcatheter pulmonary valve implant.

    Science.gov (United States)

    Berman, Darren P; Burke, Redmond; Zahn, Evan M

    2012-06-01

    Transcatheter pulmonary valve implantation in the setting of right ventricle-to-pulmonary artery conduit dysfunction is a relatively new procedure with encouraging early and midterm results. Malpositioning of the valve during implantation is a potentially serious complication. This report describes a case in which valve malpositioning was avoided by the use of a unique hybrid approach. This approach may prove to be useful for a select group of patients requiring pulmonary valve replacement.

  9. First in human implantation of the mechanical expanding Lotus® valve in degenerated surgical valves in mitral position.

    Science.gov (United States)

    Schaefer, Ulrich; Conradi, Lenard; Lubos, Edith; Deuschl, Florian; Schofer, Niklas; Seiffert, Moritz; Treede, Hendrik; Schirmer, Johannes; Reichenspurner, Hermann; Blankenberg, Stefan

    2015-12-01

    Implantation of transcatheter heart valves (THV) into degenerated surgical valves is an emerging therapy for selected high-risk patients. Although, CE mark of most THV is limited for native aortic valvular stenosis, transcatheter valve implantation into degenerated bioprostheses, even in mitral position is very intriguing. After placement of a cerebral protection device (Claret Sentinel®), three consecutive patients (age, 79.0 ± 6.1; log EuroSCORE I: 33.3 ± 9.2%) with a degenerated mitral bioprosthesis were treated by transapical implantation of the Lotus® valve (Boston Scientific Inc.). In addition, a SwanGanz catheter was introduced in the pulmonary artery for hemodynamic assessments all patients. Procedural success was 100%. Valve implantation was performed without rapid ventricular pacing. Resheating was performed in two patients due to suboptimal initial positioning. Invasive online hemodynamics revealed stable blood pressure in all patients. After Lotus® valve implantation, valvular mitral regurgitation was completely eliminated in all patients. One patient had a mild paravalvular leak of the surgical bioprosthesis, which was present before implantation. Invasive right and left heart hemodynamics showed an immediate improvement after Lotus® valve implantation. Mean mitral surface area (2.1 ± 0.2 cm(2) ) and mean gradient (3.7 ± 2.1 mm Hg) demonstrated satisfactory results. All patients were immediately extubated and discharged from the hospital without any adverse event. This study demonstrates for the first time the feasibility of transapical Lotus® Valve implantation in degenerated mitral bioprostheses. The controlled mechanical Lotus® valve expansion with remarkably stable hemodynamics throughout the procedure offers a new and valuable treatment option. © 2015 Wiley Periodicals, Inc.

  10. Reevaluation of the indications for permanent pacemaker implantation after transcatheter aortic valve implantation

    DEFF Research Database (Denmark)

    Bjerre Thygesen, Julie; Loh, Poay Huan; Cholteesupachai, Jiranut

    2014-01-01

    AIMS: Conduction abnormalities (CA) requiring permanent pacemaker (PPM) are a well-known complication after transcatheter aortic valve implantation (TAVI). This study aimed to determine the incidence of TAVI-related PPM and reevaluate the indications for PPM after the periprocedural period. METHO...

  11. Reevaluation of the indications for permanent pacemaker implantation after transcatheter aortic valve implantation

    DEFF Research Database (Denmark)

    Bjerre Thygesen, Julie; Loh, Poay Huan; Cholteesupachai, Jiranut

    2014-01-01

    AND RESULTS: A total of 258 consecutive patients underwent TAVI with the Medtronic CoreValve (MCV), whereas 24 patients were excluded from the study. TAVI-related PPM was defined as PPM implantation ≤30 days after the procedure and due to atrioventricular block (AVB). Third-degree AVB, second-degree type...

  12. Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve.

    Science.gov (United States)

    Gonska, Birgid; Seeger, Julia; Keßler, Mirjam; von Keil, Alexander; Rottbauer, Wolfgang; Wöhrle, Jochen

    2017-08-01

    Predictors for the need of permanent pacemaker implantation (PPMI) in the context of transcatheter aortic valve implantation (TAVI) are not well defined yet. We evaluated the impact of conduction disturbances, calcium volume of the device landing zone, oversizing and implantation depth on PPMI after TAVI with the balloon-expandable Edwards Sapien 3 (ES3). 335 consecutive patients undergoing transfemoral TAVI with the ES3 for the treatment of symptomatic severe aortic stenosis were included (clinicaltrials NCT02162069). Rate of PPMI after TAVI was 18.4%, excluding patients with permanent pacemakers prior to TAVI or valve-in-valve implantations. Patients requiring PPMI more often had first degree atrioventricular block (AVB) at baseline (48.7 vs. 16.5%, p < 0.01), preprocedural complete right bundle branch block (RBBB; 25.0 vs. 3.9%, p < 0.01) and higher calcium volume of the aortic valve (258.5 ± 317.3 vs. 163.6 ± 178.8 mm³, p < 0.01). There was a trend towards higher rate of PPMI in patients with new-onset left bundle branch block after TAVI (32.7 vs. 20.7%, p = 0.06). Multivariate logistic regression analysis showed that baseline first degree AVB (odds ratio 3.9, 95% confidence interval 1.73-9.10, p < 0.01) and preprocedural complete RBBB (odds ratio 4.5, 95% confidence interval 1.50-13.21, p < 0.01) were independent predictors of PPMI. Of note, neither oversizing nor implantation depth were independent predictors for need of PPMI with the ES3. In patients treated with the ES3 for symptomatic severe aortic stenosis first degree AVB and complete RBBB at baseline were independently associated with higher rates of postprocedural PPMI, whereas implantation depth and oversizing did not have an impact on PPMI.

  13. Immediate post-operative responses to transcatheter aortic valve implantation

    DEFF Research Database (Denmark)

    Egerod, Ingrid; Nielsen, Susanne; Lisby, Karen H.

    2015-01-01

    Background:Conventional treatment for patients with severe symptomatic aortic stenosis is surgical aortic valve replacement (SAVR), but transcatheter aortic valve implantation (TAVI) has become a reliable alternative in high-risk patients.Aims:The aim of our study was to describe the post-operative....../haematoma/oozing from femoral insertion site in 23 (45%)/10 (19%)/23 (43%) patients.Conclusion:Patients older than 80 years did as well as the younger patients in our study; the main complaints were post-operative pain and disrupted sleep. Our numbers are small, but most patients experienced considerable pain......, predominantly continuous and at rest. We recommend the development of an evidence-based pathway to address the immediate post-operative issues in TAVI patients. Non-pharmacological interventions to prevent pain and promote sleep need to be explored....

  14. Transcatheter aortic valve implantation: where are we now?

    Science.gov (United States)

    Mariathas, Mark; Rawlins, John; Curzen, Nick

    2017-11-01

    Transcatheter aortic valve implantation (TAVI) was first used in clinical practice in 2002. Since 2002, there has been a rapid increase in TAVI activity in patients with symptomatic severe aortic stenosis. This has been supported by systematic randomized data comparing TAVI against the gold standard treatment for the last 50 years' surgical aortic valve replacement. TAVI is now currently a recommended therapeutic intervention in the treatment of severe aortic stenosis patients who are deemed either high risk or inoperable. The indications for TAVI continue to expand. Within this review we will focus on the current guidelines for TAVI, the evidence for it, the complications of TAVI, postprocedure care, the technology available to clinicians now and finally the future perspectives for TAVI.

  15. Morbidity and mortality of nonagenarians undergoing CoreValve implantation

    Directory of Open Access Journals (Sweden)

    Akin Ibrahim

    2012-09-01

    Full Text Available Abstract Background Nonagenarians are mostly denied from different therapeutic strategies due to high comorbidity index and risk-benefit calculation. We present the results of nonagenarians with high comorbidity index not eligible for conventional aortic valve surgery undergoing transcatheter aortic valve implantation (TAVI with the CoreValve system. Methods Our retrospective analysis include baseline parameters, procedural characteristics, morbidity, mortality as well as twelve-lead surface ECG and echocardiographic parameters which were revealed preinterventionally, at hospital discharge and at 30-day follow-up. Clinical follow-up was performed 6 months after TAVI. Results Out of 158 patients 11 nonagenarians with a mean age of 92.6 ± 1.3 years suffering from severe aortic valve stenosis and elevated comorbidity index (logistic EuroSCORE of 32.0 ± 9.5%, STS score 25.3 ± 9.7% underwent TAVI between January 2008 and January 2011 using the third-generation percutaneous self-expanding CoreValve prosthesis. Baseline transthoracic echocardiography reported a mean aortic valve area (AVA of 0.6 ± 0.2 cm2 with a mean and peak pressure gradient of 60.2 ± 13.1mmHg and 91.0 ± 27.4mmHg, respectively. The 30-day follow up all cause and cardiovascular mortality was 27.3% and 9.1%, respectively. One major stroke (9.1%, 2 pulmonary embolisms (18.2%, 1 periprocedural (9.1% and 1 (9.1% spontaneous myocardial infarction occured. Life-threatening or disabling bleeding occurred in 2 cases (18.2%, and minor bleeding in 7 cases (63.6%. Mean severity of heart failure according to NYHA functional class improved from 3.2 ± 0.8 to 1.36 ± 0.5 while mean AVA increased from 0.6 ± 0.2cm2 to 1.8 ± 0.2cm2. At 6-months follow-up 8 patients (72.7% were alive without any additional myocardial infarction, pulmonary embolism, bleeding, or stroke as compared to 30-day follow-up. Conclusion Our case series demonstrate that even with

  16. Transcatheter mitral valve implantation for inoperable severely calcified native mitral valve disease: A systematic review.

    Science.gov (United States)

    Puri, Rishi; Abdul-Jawad Altisent, Omar; del Trigo, Maria; Campelo-Parada, Francesco; Regueiro, Ander; Barbosa Ribeiro, Henrique; DeLarochellière, Robert; Paradis, Jean-Michel; Dumont, Eric; Rodés-Cabau, Josep

    2016-02-15

    Transcatheter mitral valve implantation (TMVI) for severely calcified native mitral valve disease recently emerged as a treatment option in patients deemed inoperable by conventional techniques. Yet no systematic appraisal currently exists characterizing this novel treatment paradigm. A systematic literature review summarizing the clinical, anatomical, peri- and post-procedural characteristics underscoring the technical feasibility of this procedure was performed. Nine publications describing 11 patients [mean age 68 ± 10 years, 82% female, 82% severe mitral stenosis (MS), 18% severe mitral regurgitation (MR)] were identified. Mean STS score, trans-mitral gradient and effective orifice area were 10.5 ± 4.6%, 12 ± 2.4 mm Hg and 0.93 ± 0.06 cm(2) respectively. All patients had severe, circumferential mitral annular calcification on imaging. Dedicated balloon-expanding transcatheter aortic valves were used in 10/11 cases, with 8/11 cases involving a true percutaneous approach with peri-procedural 3D trans-esophageal echocardiographic guidance; 3/11 cases involved an open left atrial approach. Following initial balloon inflation and valve deployment, procedural success rate was 73%, without residual paravalvular leaks (PVL). Successful immediate re-deployment of a 2nd valve was needed in 2 instances following significant PVL detection. Residual trans-valvular gradients ranged from 3 to 7 mm Hg, with no patient demonstrating >grade 2 MR. All patients survived the procedure, with 2 reported deaths on days 10- and 41 post-TMVI being non-cardiac-related. Mid-term clinical follow-up, reported in 8 patients, revealed 6 patients to be alive at 3-months with much improved functional status. TMVI for native severely calcified mitral valve disease appears technically feasible with acceptable initial acute and mid-term hemodynamic and clinical outcomes. The outcomes of an ongoing, dedicated global Sapien TMVI registry will shed further light on this evolving treatment

  17. Outcome after transvascular transcatheter aortic valve implantation in 2016.

    Science.gov (United States)

    Gaede, Luise; Blumenstein, Johannes; Liebetrau, Christoph; Dörr, Oliver; Kim, Won-Keun; Nef, Holger; Husser, Oliver; Elsässer, Albrecht; Hamm, Christian W; Möllmann, Helge

    2017-12-08

    We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing transvascular transcatheter aortic valve implantation (TV-TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) from 2014 to 2016 in Germany. All aortic valve procedures performed in Germany are mandatorily registered in a quality control program. More than 15 000 TV-TAVI procedures were performed in 2016 in Germany. Especially the number of post-procedural complications declined within the last few years, including new pacemaker implantations (2015: 12.6% vs. 2016: 11.4%, P = 0.002) and vascular complications (2015: 8.5% vs. 2016: 7.1%; P TV-TAVI was 2.6%, which is for the first time numerically below that of iSAVR, which was 2.9% (P = 0.19). A stratified analysis according to the German aortic valve score shows a lower observed than expected in-hospital mortality rate for TV-TAVI (O/E 0.68). Additionally, the in-hospital mortality was significantly lower after TV-TAVI than after iSAVR in the very high- (11.3% vs. 23.6%; P TV-TAVI was numerically lower than after iSAVR in 2016 for the first time. In the low risk group in-hospital mortality was similar, whereas in all other risk groups in-hospital mortality after TV-TAVI was significantly lower than after SAVR. This is likely to contribute to a redefinition of the standard of care in the future.

  18. A rare complication: an attempt of retrieval of an aortic valve wrapped with pig tail catheter during transcatheter aortic valve implantation.

    Science.gov (United States)

    Yildiz, Bekir Serhat; Alihanoglu, Yusuf Izzettin; Alur, Ihsan; Evrengul, Harun; Kaya, Dayimi

    2015-09-01

    Transcatheter aortic valve implantation is preferred to treat high surgical risk patients with severe aort stenosis. Wrapping of a pig tail catheter with device struts during transcatheter aortic valve implantation is a very rare complication. In this report, we present the images and videos of an attempt of retrieval of an aortic valve wrapped with pig tail catheter during transcatheter aortic valve implantation in a 71-year-old man. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Automatic Estimation of Optimal Deployment of Transcatheter Aortic Valve Implantation Using Computed Tomography.

    Science.gov (United States)

    Kerner, Arthur; Abadi, Sobhi; Dotan, Roy; Javitt, Marcia; Aronson, Doron; Lessick, Jonathan

    2017-03-01

    A comparison was made between the accuracy of and time saved by using novel automated software for pre-procedural computed tomography (CT) planning before transcatheter aortic valve implantation (TAVI) and manual methods. Preprocedural CT to assess aortic annulus dimensions and predict the optimal C-arm implant angle before TAVI can reduce complications related to incorrect prosthesis sizing and positioning. A total of 61 consecutive patients underwent TAVI using either the SAPIEN XT or CoreValve prosthesis. Pre-procedural CT scans were analysed using three methods: automatic; semi-automatic; and manual. For each method, annular dimensions were measured and the optimal implantation angle was predicted. After TAVI the actual post-deployment angle orthogonal to the prosthesis was determined using aortic fluoroscopy. The difference between the predicted angle by CT and the measured post-deployment angle was calculated for each method. For all methods the mean angular difference with the actual post-deployment angle was similar at ~9 ± 7°. There was a significant difference between the SAPIEN XT (6.6 ± 5.8°) and CoreValve (11.5 ± 6.9°, p automatic' results were consistently larger than 'manual' results. Interobserver variability was low for all measures. The fully automatic method saved 98 s, and the semiautomatic method 40 s per case. The use of automatic software enabled a rapid and accurate prediction of implantation angles, though results differed for specific manufacturers. Annular areas were overestimated by the automatic method, and thus required manual adjustments.

  20. Transcatheter Replacement of Failed Bioprosthetic Valves: Large Multicenter Assessment of the Effect of Implantation Depth on Hemodynamics After Aortic Valve-in-Valve.

    Science.gov (United States)

    Simonato, Matheus; Webb, John; Kornowski, Ran; Vahanian, Alec; Frerker, Christian; Nissen, Henrik; Bleiziffer, Sabine; Duncan, Alison; Rodés-Cabau, Josep; Attizzani, Guilherme F; Horlick, Eric; Latib, Azeem; Bekeredjian, Raffi; Barbanti, Marco; Lefevre, Thierry; Cerillo, Alfredo; Hernández, José María; Bruschi, Giuseppe; Spargias, Konstantinos; Iadanza, Alessandro; Brecker, Stephen; Palma, José Honório; Finkelstein, Ariel; Abdel-Wahab, Mohamed; Lemos, Pedro; Petronio, Anna Sonia; Champagnac, Didier; Sinning, Jan-Malte; Salizzoni, Stefano; Napodano, Massimo; Fiorina, Claudia; Marzocchi, Antonio; Leon, Martin; Dvir, Danny

    2016-06-01

    Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets for implantation that would improve hemodynamics after ViV. Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated postprocedural gradients (mean ≥20 mm Hg). Optimal implantation depths were defined by receiver operating characteristic curve. A total of 292 consecutive patients (age, 78.9±8.7 years; 60.3% male; 157 CoreValve Evolut and 135 Sapien XT) were evaluated. High implantation was associated with significantly lower rates of elevated gradients in comparison with low implantation (CoreValve Evolut, 15% versus 34.2%; P=0.03 and Sapien XT, 18.5% versus 43.5%; P=0.03, respectively). Optimal implantation depths were defined: CoreValve Evolut, 0 to 5 mm; Sapien XT, 0 to 2 mm (0-10% frame height); sensitivities, 91.3% and 88.5%, respectively. The strongest independent correlate for elevated gradients after ViV was device position (high: odds ratio, 0.22; confidence interval, 0.1-0.52; P=0.001), in addition to type of device used (CoreValve Evolut: odds ratio, 0.5; confidence interval, 0.28-0.88; P=0.02) and surgical valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51-6.45; P=0.002). High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self- and balloon-expandable transcatheter valves. These clinical evaluations support specific implantation targets to optimize hemodynamics after ViV. © 2016 American Heart Association, Inc.

  1. When operable patients become inoperable: conversion of a surgical aortic valve replacement into transcatheter aortic valve implantation

    DEFF Research Database (Denmark)

    Olsen, Lene Kjaer; Arendrup, Henrik; Engstrøm, Thomas

    2009-01-01

    Transcatheter aortic valve implantation (TAVI) is a relatively new treatment option for inoperable patients with severe aortic stenosis (AS). This case describes how a planned conventional surgical aortic valve replacement (AVR) on a 73-year-old woman was successfully converted to a TAVI procedure....... On extracorporal circulation it was reconized that the aortic annulus, the coronary ostiae and the proximal part of the ascending aorta were severely calcified making valve implantation impossible. Surgical closure without valve substitution was estimated to be associated with a high risk of mortality due......, and the prosthesis was sutured to the ascending aorta. With some manipulation of the prosthesis it was possible to suture the aorta circumferentially around the fully expanded upper part of the prosthesis. Post-procedurally the patient recovered successfully, with improved function capacity, aortic valve area...

  2. Distal coronary embolisation during transcatheter aortic valve implantation.

    Science.gov (United States)

    Tsujimura, Akira; Saito, Naritatsu; Minakata, Kenji; Kimura, Takeshi

    2016-07-07

    A 92-year-old woman was admitted to a hospital with severe aortic valve stenosis for transcatheter aortic valve implantation (TAVI). TAVI was performed under general anaesthesia. After balloon valvuloplasty, the patient became hypotensive and transesophageal echocardiography showed severe aortic regurgitation with severely depressed left ventricular wall motion. A 26 mm Sapien XT valve was deployed. However, the ventricular wall motion was still severely depressed. Coronary angiography showed occlusion of the mid-left anterior descending (LAD) artery. After crossing a 0.014″ guidewire, manual vacuum aspiration was conducted and multiple emboli were removed. 2 drug-eluting stents were deployed in the LAD artery. Following this, the left ventricular wall motion improved. The patient's failure symptoms improved remarkably after TAVI. Histopathological examination of the aspirated emboli was compatible with a recent thrombus containing platelets, fibrin, erythrocytes and leucocytes. This is the first report to describe a distal coronary embolisation during TAVI with histopathological confirmation of the embolus. 2016 BMJ Publishing Group Ltd.

  3. The importance of echocardiography in transcatheter aortic valve implantation.

    Science.gov (United States)

    Bilen, Emine; Sari, Cenk; Durmaz, Tahir; Keleş, Telat; Bayram, Nihal A; Akçay, Murat; Ayhan, Hüseyin M; Bozkurt, Engin

    2014-01-01

    Valvular heart diseases cause serious health problems in Turkey as well as in Western countries. According to a study conducted in Turkey, aortic stenosis (AS) is second after mitral valve disease among all valvular heart diseases. AS is frequently observed in elderly patients who have several cardiovascular risk factors and comorbidities. In symptomatic severe AS, surgical aortic valve replacement (AVR) is a definitive treatment. However, in elderly patients with left ventricular dysfunction and comorbidities, the risk of operative morbidity and mortality increases and outweighs the gain obtained from AVR surgery. As a result, almost one-third of the patients with serious AS are considered ineligible for surgery. Transcatheter aortic valve implantation (TAVI) is an effective treatment in patients with symptomatic severe AS who have high risk for conventional surgery. Since being performed for the first time in 2002, with a procedure success rate reported as 95% and a mortality rate of 5%, TAVI has become a promising method. Assessment of vascular anatomy, aortic annular diameter, and left ventricular function may be useful for the appropriate selection of patients and may reduce the risk of complications. Cardiac imaging methods including 2D and 3D echocardiography and multidetector computed tomography are critical during the evaluation of suitable patients for TAVI as well as during and after the procedure. In this review, we describe the role of echocardiography methods in clinical practice for TAVI procedure in its entirety, i.e. from patient selection to guidance during the procedure, and subsequent monitoring. © 2013, Wiley Periodicals, Inc.

  4. The power of disruptive technological innovation: Transcatheter aortic valve implantation.

    Science.gov (United States)

    Berlin, David B; Davidson, Michael J; Schoen, Frederick J

    2015-11-01

    We sought to evaluate the principles of disruptive innovation, defined as technology innovation that fundamentally shifts performance and utility metrics, as applied to transcatheter aortic valve implantation (TAVI). In particular, we considered implantation procedure, device design, cost, and patient population. Generally cheaper and lower performing, classical disruptive innovations are first commercialized in insignificant markets, promise lower margins, and often parasitize existing usage, representing unattractive investments for established market participants. However, despite presently high unit cost, TAVI is less invasive, treats a "new," generally high risk, patient population, and is generally done by a multidisciplinary integrated heart team. Moreover, at least in the short-term TAVI has not been lower-performing than open surgical aortic valve replacement in high-risk patients. We conclude that TAVI extends the paradigm of disruptive innovation and represents an attractive commercial opportunity space. Moreover, should the long-term performance and durability of TAVI approach that of conventional prostheses, TAVI will be an increasingly attractive commercial opportunity. © 2014 Wiley Periodicals, Inc.

  5. A second-time percutaneous aortic-valve implantation for bioprosthetic failure.

    Science.gov (United States)

    Codner, Pablo; Assali, Abid; Vaknin Assa, Hana; Kornowski, Ran

    2015-09-01

    We report a case of an 84-year-old man with a history of surgical aortic-valve replacement for chronic aortic regurgitation (AR) who later developed severe prosthetic valve AR. Subsequent treatment with a Corevalve® was unsuccessful with severe AR seen at 3 years after the valve-in-valve procedure. The patient was then successfully treated with a second catheter-based Corevalve® implantation.

  6. Transcatheter aortic valve implantation with the self-expandable venus A-Valve and CoreValve devices: Preliminary Experiences in China.

    Science.gov (United States)

    Liao, Yan-Biao; Zhao, Zhen-Gang; Wei, Xin; Xu, Yuan-Ning; Zuo, Zhi-Liang; Li, Yi-Jian; Zheng, Ming-Xia; Feng, Yuan; Chen, Mao

    2017-03-01

    Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an effective alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis who are deemed high risk or inoperable. Currently, TAVI procedures in China mostly make use of the domestic Venus A-Valve and the CoreValve; however, there is no data on their comparative performance. Consecutive patients undergoing TAVI with the aforementioned devices were included. The outcomes were reported according to the Valve Academic Research Consortium-2 (VARC) definitions. A total of 54 TAVI procedures were performed, 27 with the CoreValve and the other 27 with the Venus A-Valve. An additional valve was required in 4 (14.8%) and 3 (11.1%) patients, and the VARC-2 device success rates were 81.5 and 85.2%, respectively. The incidences of common complications were similar, except for the significantly less frequent pacemaker insertion in the Venus A-Valve group (7.4 vs. 37.0%, P = 0.03). Within 30 days, 2 (3.7%) patients died, 1 in each group, and both had a bicuspid aortic valve (BAV). No other serious complications, such as annular rupture, coronary obstruction and aortic dissection, occurred in the 32 BAV patients treated with the Venus A-Valve (14) or the CoreValve (18). After 2-years of follow-up, there was no significant difference between CoreValve group and Venus-A group (11.1 vs. 7.4%, P = 0.64). TAVI with the domestic Venus A-Valve is feasible, safe, and can produce favorable short-term outcomes comparable to those with the CoreValve in inoperable or high-risk patients with tricuspid and bicuspid aortic valve stenosis. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  7. Transcatheter Tricuspid Valve-In-Valve Implantation in Patients with Tricuspid Bioprosthetic Valve Degeneration at High Surgical Risk: A Multicenter Case Series.

    Science.gov (United States)

    Landes, Uri; Kerner, Arthur; Segev, Amit; Danenberg, Haim; Shapira, Yaron; Finkelstein, Ariel; Kornowski, Ran

    2017-03-01

    Transcatheter tricuspid valve-in-valve implantation (TVIV) is an attractive yet under-explored alternative to redo valve surgery. To report the multicenter TVIV experience in Israel. We approached multiple centers and collected data regarding seven TVIV cases. The study group comprised seven participants: five females and two males, with a mean age of 63 ± 12 years and EuroSCORE-II 13.6 ± 3.3%. Follow-up ranged from 3 to 21 months (mean 8 ± 6 months). All presented with advanced heart failure. The indication for valve intervention was a predominant tricuspid stenosis in three patients, significant tricuspid regurgitation in one and a mixture in three. Six procedures were conducted via a transfemoral approach and one by transatrial access. The Edwards SAPIENTM XT valve was used in four cases and the SAPIENTM 3 in three. Without pre-stenting/rapid pacing, all participants underwent successful valve implantation. Mean transvalvular gradient decreased from 11 ± 3 mmHg to 6 ± 3 mmHg (P = 0.003) and regurgitation decreased from moderate/severe (in four cases) to none/trace (in six of the seven cases). One patient remained severely symptomatic and died 3.5 months after the implantation. All others achieved a functional capacity improvement and amelioration of symptoms soon after the implantation, which persisted during follow-up. TVIV may be a safe and effective strategy to treat carefully selected patients with degenerated bioprosthetic tricuspid valve at high operative risk.

  8. Clinical outcomes after combined Ahmed glaucoma valve implantation and penetrating keratoplasty or pars plana vitrectomy.

    Science.gov (United States)

    Lee, Jin Young; Sung, Kyung Rim; Tchah, Hung Won; Yoon, Young Hee; Kim, June Gone; Kim, Myoung Joon; Kim, Jae Yong; Yun, Sung-Cheol; Lee, Joo Yong

    2012-12-01

    To evaluate whether a combination of penetrating keratoplasty (PKP) or pars plana vitrectomy (PPV) and Ahmed glaucoma valve (AGV) implantation affords a level of success similar to that of AGV implantation alone. Eighteen eyes underwent simultaneous PPV and AGV, 14 eyes with PKP and AGV and 30 eyes with AGV implantation alone were evaluated. Success was defined as attainment of an intraocular pressure (IOP) >5 and AGV implantation-alone group. Cox proportional hazard regression analysis was conducted to identify factors predictive of success in each of the three groups. Mean (±standard deviation) preoperative IOP was 30.2 ± 10.2 mmHg in the PKP + AGV, 35.2 ± 9.8 mmHg in the PPV + AGV, and 36.2 ± 10.1 mmHg in the AGV implantation-alone group. The cumulative success rate at 18 months was 66.9%, 73.2%, and 70.8% in the three groups, respectively. Neither combined surgery group differed significantly in terms of cumulative success rate compared with the AGV implantation-alone group (p = 0.556, p = 0.487, respectively). The mean number of preoperative anti-glaucoma medications prescribed was significantly associated with success in the PKP + AGV implantation group (hazard ratio, 2.942; p = 0.024). Either PKP or PPV performed in conjunction with AGV implantation afforded similar success rates compared to patients treated with AGV implantation alone. Therefore, in patients with refractory glaucoma who have underlying corneal or retinal pathology requiring treatment with PKP or PPV, AGV implantation can be performed simultaneously.

  9. Injectable tissue engineered pulmonary heart valve implantation into the pig model: A feasibility study.

    Science.gov (United States)

    Schlegel, Franziska; Salameh, Aida; Oelmann, Katja; Halling, Michelle; Dhein, Stefan; Mohr, Friedrich W; Dohmen, Pascal M

    2015-06-24

    Transcatheter pulmonary valve replacement is currently performed in clinical trials, however limited by the use of glutaraldehyde treated bioprostheses. This feasibility study was performed to evaluate delivery-related tissue distortion during implantation of a tissue engineered (TE) heart valves. The injectable TE heart valve was mounted on a self-expanding nitinol stent (n=7) and delivered into the pulmonary position of seven pigs, (weight 26 to 31 kg), performing a sternotomy or limited lateral thoracotomy. Prior to implantation, the injectable TE heart valve was crimped and inserted into an applicator. Positioning of the implants was guided by fluoroscopy and after carefully deployment angiographic examination was performed to evaluate the correct delivered position. Hemodynamic measurements were performed by epicardial echocardiography. Finally, the animals were sacrificed and the injectable TE heart valves were inspected by gross examination and histological examination. Orthotopic delivery of the injectable TE heart valves were all successful performed, expect in one were the valve migrated due to a discrepancy of pulmonary and injectable TE valve size. Angiographic evaluation (n=6) showed normal valve function, supported by epicardial echocardiography in which no increase flow velocity was measured, neither trans- nor paravalvular regurgitation. Histological evaluation demonstrated absence of tissue damage due to the delivery process. Transcatheter implantation of an injectable TE heart valve seems to be possible without tissue distortion due to the delivery system.

  10. Hybrid pulmonary valve implantation: injection of a self-expanding tissue valve through the main pulmonary artery.

    Science.gov (United States)

    Dittrich, Sven; Gloeckler, Martin; Arnold, Raoul; Sarai, Koppany; Siepe, Matthias; Beyersdorf, Friedhelm; Schlensak, Christian

    2008-02-01

    An 8-year-old (35 kg) boy presented with progressive right ventricular outflow tract enlargement (28 mm) and progressive tricuspid regurgitation after transannular repair of tetralogy of Fallot and was scheduled for pulmonary valve replacement. To spare reoperation on full sternotomy, a transverse mini-thoracotomy through the third intercostal space was used to implant an injectable 29-mm stented porcine valve directly through an incision of the pulmonary artery bifurcation. The procedure was performed while rapid ventricular pacing and right ventricular unload by a short running femorally implanted cardiopulmonary bypass. The stented valve was fixed with three single sutures to avoid embolization. The interventional result was well with full competence of the valve. The boy was discharged at day 4 after the procedure.

  11. Transcatheter aortic valve implantation with either CoreValve or SAPIEN XT devices in patients with a single coronary artery.

    Science.gov (United States)

    Sorbets, Emmanuel; Choby, Michael; Tchetche, Didier

    2012-07-01

    Transcatheter aortic valve implantation (TAVI) is associated with a risk of coronary obstruction. This complication is potentially lethal when the origin of the coronary arteries is anomalous. We describe two cases of TAVI with the SAPIEN XT (Edwards Lifesciences) and CoreValve devices (Medtronic) in patients with a single coronary artery. The tools and techniques used to anticipate the risk of acute coronary occlusion are discussed.

  12. Cognitive Outcomes following Transcatheter Aortic Valve Implantation: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Ka Sing Paris Lai

    2015-01-01

    Full Text Available Severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and contributes to a large proportion of all deaths over the age of 70. Severe aortic stenosis is conventionally treated with surgical aortic valve replacement; however, the less invasive transcatheter aortic valve implantation (TAVI is suggested for those at high surgical risk. While TAVI has been associated with improved survival and favourable outcomes, there is a higher incidence of cerebral microembolisms in TAVI patients. This finding is of concern given mechanistic links with cognitive decline, a symptom highly prevalent in those with cardiovascular disease. This paper reviews the literature assessing the possible link between TAVI and cognitive changes. Studies to date have shown that global cognition improves or remains unchanged over 3 months following TAVI while individual cognitive domains remain preserved over time. However, the association between TAVI and cognition remains unclear due to methodological limitations. Furthermore, while these studies have largely focused on memory, cognitive impairment in this population may be predominantly of vascular origin. Therefore, cognitive assessment focusing on domains important in vascular cognitive impairment, such as executive dysfunction, may be more helpful in elucidating the association between TAVI and cognition in the long term.

  13. Transapical implantation of a self-expandable aortic valve prosthesis utilizing a novel designed positioning element.

    Science.gov (United States)

    Liu, Xiaopeng; Tang, Yue; Luo, Fuliang; Tian, Yi; Li, Kai; Sun, Jiakang; Jia, Liujun; Wang, Wei

    2017-01-01

    To evaluate a new transapical system which utilizes a novel designed positioning element and a two-step positioning mechanism for easy and accurate implantation of transcatheter valves. Transcatheter aortic valve implantation is an important treatment option for non-surgical patients with severe aortic stenosis. However, accurate placement of the transcatheter valve remains challenging. Self-expandable aortic valve prosthesis with a flexibly connected, annulus-like positioning element was implanted through a transapical approach in 12 pigs. The positioning element was separated and can be released independent of the valve prosthesis. During valve implantation, firstly, the positioning element was unsheathed and fixed into the aortic sinus. Then, the prosthetic valve was guided to an anatomically oriented position and deployed. Six animals were followed up to 180 days. With the help of the positioning element, all 12 valves were successfully deployed at the anticipated site. The valve release procedure took an average of 7.3 ± 2.5 min. The mean transvalvular pressure gradient was 2.8 ± 1.1 mm Hg at valve deployment. Of the six chronic animals, the mean transvalvular pressure gradient was 3.0 ± 1.0 mm Hg on day 7, and 2.9 ± 1.6 mm Hg on day 180 (P = 0.91). No migration, embolization, or coronary obstruction was observed during surgery and at necropsy. Pathological examination showed anatomically correct positioning of the prosthetic valve without signs of thrombosis or calcification. In this study, we confirmed the feasibility of the J-Valve transapical system for transapical implantation through a two-step process. Satisfactory hemodynamic and pathological performance during a follow-up of 180 days was demonstrated. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  14. Percutaneous transcatheter one-step mechanical aortic disc valve prosthesis implantation: a preliminary feasibility study in swine.

    Science.gov (United States)

    Sochman, Jan; Peregrin, Jan H; Rocek, Miloslav; Timmermans, Hans A; Pavcnik, Dusan; Rösch, Josef

    2006-01-01

    To evaluate the feasibility of one-step implantation of a new type of stent-based mechanical aortic disc valve prosthesis (MADVP) above and across the native aortic valve and its short-term function in swine with both functional and dysfunctional native valves. The MADVP consisted of a folding disc valve made of silicone elastomer attached to either a nitinol Z-stent (Z model) or a nitinol cross-braided stent (SX model). Implantation of 10 MADVPs (6 Z and 4 SX models) was attempted in 10 swine: 4 (2 Z and 2 SX models) with a functional native valve and 6 (4 Z and 2 SX models) with aortic regurgitation induced either by intentional valve injury or by MADVP placement across the native valve. MADVP function was observed for up to 3 hr after implantation. MADVP implantation was successful in 9 swine. One animal died of induced massive regurgitation prior to implantation. Four MADVPs implanted above functioning native valves exhibited good function. In 5 swine with regurgitation, MADVP implantation corrected the induced native valve dysfunction and the device's continuous good function was observed in 4 animals. One MADVP (SX model) placed across native valve gradually migrated into the left ventricle. The tested MADVP can be implanted above and across the native valve in a one-step procedure and can replace the function of the regurgitating native valve. Further technical development and testing are warranted, preferably with a manufactured MADVP.

  15. Transapical implantation of a novel self-expanding sutureless aortic valve prosthesis.

    Science.gov (United States)

    Stalder, Mario; Suri, Rakesh M; Kraehenbuehl, Eva S; Hellige, Gerrit; Wenaweser, Peter; Zobrist, Claudia; Schaff, Harzell V; Carrel, Thierry P

    2010-03-01

    To date, transapical aortic valve implantation has required a balloon-expandable stented valve prosthesis. More recently, a novel self-expanding sutureless stented bovine pericardial prosthesis has been developed which allows rapid aortic valve replacement via an open transaortic approach in humans. The aim of this animal study was to develop a reliable protocol to facilitate the transapical implantation of this self-expanding valve in a porcine model. Off-pump transapical aortic valve implantation was performed through a left mini-thoracotomy using a bovine pericardial valve mounted on a self-expandable nitinol stent of size 21 mm and 23 mm in 11 pigs (average weight 60 kg). The crimped valve was introduced through the left ventricular apex using a flexible and steerable delivery sheath, using a three-step technique. Biplane fluoroscopy and transesophageal echocardiography were simultaneously used for guidance. Successful adjustment of alignment along three axes prior to deployment of the valve was accomplished in each animal. Deployments were performed during a period of rapid pacing. All valves were successfully deployed and functioned normally following transapical removal of the delivery system. Paravalvular leak was documented in one case (9.1%) due to prosthetic misalignment. There was no evidence of valve migration. Correct anatomic seating was confirmed during post-procedure necropsy. Successful transapical implantation of a novel self-expandable bovine pericardial valve was accomplished in 11 animals, without cardiopulmonary bypass. A flexible, steerable delivery system with a three-step release mechanism allowed precise positioning of the valve with a low rate of paravalvular leakage, and excellent device stability.

  16. An up-to-date overview of the most recent transcatheter implantable aortic valve prostheses

    NARCIS (Netherlands)

    Wiegerinck, Esther M. A.; van Kesteren, Floortje; van Mourik, Martijn S.; Vis, Marije M.; Baan, Jan

    2016-01-01

    Over the past decade transcatheter aortic valve implantation (TAVI) has evolved towards the routine therapy for high-risk patients with severe aortic valve stenosis. Technical refinements in TAVI are rapidly evolving with a simultaneous expansion of the number of available devices. This review will

  17. First-in-man implantation of the retrievable and repositionable VenusA-Plus valve.

    Science.gov (United States)

    Liu, Xian-Bao; He, Yu-Xin; Liu, Chun-Hui; Wang, Li-Han; Gao, Feng; Yu, Lei; Dong, Ai-Qiang; Kong, Min-Jian; Chen, Ji-Fang; Xu, Yong; Zhou, Qi-Jing; Yan, Min; Wang, Jian-An

    2018-01-01

    No retrievable and repositionable second generation transcatheter aortic valve is available in China. Here, we report the first-in-man implantation of the retrievable and repositionable VenusA-Plus valve. A 76-year-old patient with symptomatic severe aortic stenosis and high surgical risk (STS 13.8%) was recommended for transcatheter aortic valve replacement (TAVR) by heart valve team. Type 0 bicuspid aortic valve with asymmetric calcification was identified by dual source computed tomography, and the unfavorable anatomies increased the possibility of malposition and paravalvular leakage during TAVR. Therefore, we used the retrievable and repositionable VenusA-Plus valve for the patient. Transfemoral TAVR was performed under local anesthesia with sedation, and a 26mm VenusA-Plus valve was successfully implanted. No transvalvular pressure gradient and trace paravalvular leakage were found. The successful first-in-man implantation indicates the retrievable and repositionable VenusA-Plus valve is feasible in complicated TAVR cases such as bicuspid aortic valve.

  18. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document

    NARCIS (Netherlands)

    A.P. Kappetein (Arie Pieter); S.J. Head (Stuart); P. Généreux (Philippe); N. Piazza (Nicolo); N.M. van Mieghem (Nicolas); E.H. Blackstone (Eugene); T.G. Brott (Thomas); D.J. Cohen (David J.); D.E. Cutlip (Donald); G.A. van Es (Gerrit Anne); R.T. Hahn (Rebecca); A.J. Kirtane (Ajay); M. Krucoff (Mitchell); S. Kodali (Susheel); M.J. Mack (Michael); R. Mehran (Roxana); J. Rodés-Cabau (Josep); P. Vranckx (Pascal); J.G. Webb (John); S.W. Windecker (Stephan); P.W.J.C. Serruys (Patrick); M.B. Leon (Martin)

    2012-01-01

    textabstractObjectives: The aim of the current Valvular Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI)- clinical endpoints to make them more suitable to the present and future needs of clinical trials.

  19. Design of Over Center Valves Based on Predictable Performance

    DEFF Research Database (Denmark)

    Hansen, M.R.; Andersen, T.O.; Pedersen, P.

    2004-01-01

    this assumption and an approach to design over center valve geometries that have negative flow forces is presented with emphasis on predictability. In conclusion it is made clear that negative flow forces in the over center valve cannot solve the instability problem in general, however, it might very well...

  20. Percutaneous pulmonary valve implantation for reconstruction of a patch-repaired right ventricular outflow tract.

    Science.gov (United States)

    Esmaeili, Anoosh; Bollmann, Simone; Khalil, Markus; De Rosa, Roberta; Fichtlscherer, Stephan; Akintuerk, Hakan; Schranz, Dietmar

    2017-09-20

    Percutaneous pulmonary valve implantation (PPVI) is nowadays an accepted treatment option to repair post-surgical conduit dysfunction of the right ventricular outflow tract (RVOT). In addition, many patients need a pulmonary valve to reconstruct a hemodynamically incompetent native or conduit free outflow tract. Based on our experience with percutaneous stent-valve placement in a cohort of 125 patients, we report here transvenous reconstruction of a conduit-free, patch repaired outflow tract by utilizing balloon-expandable stent-valves in 23 patients with a median age of 22 years (5-60 years). In 20 patients, the step-by-step procedure was performed uneventful with the aimed success. Severe RVOT dysfunction in term of a clinical relevant regurgitation could be changed to mild, as it was confirmed by follow-up color Doppler echocardiography. In a 5-year-old girl a Melody® valve was placed as a surgical-interventional hybrid approach. In one patient, the procedure was complicated by stent embolization during preparation of the RVOT for stent-valve implantation. Reposition of the embolized stent was nevertheless successful for finishing percutaneous valve-implantation. In one patient, surgical approach became necessary because of the inability to advance the balloon-mounted stent-valve through a pre-stented RVOT. Considering the current available balloon-expandable stent-valves, transvenous pulmonary valve implantation is feasible to treat even an incompetent conduit-free RVOT. However, preparation of the RVOT by pre-stenting, in most patients with more than two stents in telescope technique remains challenging. Reconstruction of RVOT by the current available valves is promising only for a carefully selected group of patients. © 2017, Wiley Periodicals, Inc.

  1. Evaluation of success after second Ahmed glaucoma valve implantation.

    Science.gov (United States)

    Nilforushan, Naveed; Yadgari, Maryam; Jazayeri, Anis Alsadat; Karimi, Nasser

    2016-03-01

    To evaluate the outcome of the second Ahmed glaucoma valve (AGV) surgery in eyes with failed previous AGV surgery. Retrospective case series. Following chart review, 36 eyes of 34 patients with second AGV implantation were enrolled in this study. The primary outcome measure was surgical success defined in terms of intraocular pressure (IOP) control using two criteria: Success was defined as IOP ≤21 mmHg (criterion 1) and IOP ≤16 mmHg (criterion 2), with at least 20% reduction in IOP, either with no medication (complete success) or with no more than two medications (qualified success). Kaplan-Meier survival analysis was used to determine the probability of surgical success. The average age of the patients was 32.7 years (range 4-65), and the mean duration of follow-up was 21.4 months (range 6-96). Preoperatively, the mean IOP was 26.94 mmHg (standard deviation [SD] 7.03), and the patients were using 2.8 glaucoma medications on average (SD 0.9). The mean IOP decreased significantly to 13.28 mmHg (SD 3.59) at the last postoperative visit (P = 0.00) while the patients needed even fewer glaucoma medications on average (1.4 ± 1.1, P = 0.00). Surgical success of second glaucoma drainage devices (Kaplan-Meier analysis), according to criterion 1, at 6, 12, 18, and 42 months was 94%, 85%, 80%, and 53% respectively, and according to criterion 2, was 94%, 85%, 75%, and 45%, respectively. Repeated AGV implantation seems to be a safe modality of treatment with acceptable success rate in cases with failed previous AGV surgery.

  2. Implante valve-in-valve transcateter em posição aórtica: uma mudança de seleção? Transcatheter aortic valve-in-valve implantation: a selection change?

    Directory of Open Access Journals (Sweden)

    Diego Felipe Gaia

    2012-09-01

    Full Text Available INTRODUÇÃO: A reoperação para substituição de biopróteses aórticas com disfunção é procedimento que envolve considerável risco. Em alguns casos, a mortalidade é elevada e pode contraindicar o procedimento. O implante minimamente invasivo "valve-in-valve" transcateter de valva aórtica parece ser uma alternativa, reduzindo morbimortalidade. O objetivo deste estudo foi avaliar esses implantes utilizando a prótese Braile Inovare. MÉTODOS: A prótese Braile Inovare, transcateter, balão expansível foi utilizada em 14 casos. Euroscore médio foi de 42,9%. Todos os pacientes eram portadores de dupla disfunção de bioprótese aórtica. Os procedimentos foram realizados em ambiente cirúrgico híbrido, sob controle ecocardiográfico e fluoroscópico. Por meio de minitoracotomia esquerda, as próteses foram implantadas através do ápice ventricular, sob estimulação ventricular de alta frequência. Foram realizados controles clínicos e ecocardiográficos seriados. O seguimento variou de 1 a 30 meses. RESULTADOS: A correta liberação protética foi possível em todos os casos. Não ocorreu conversão. Não houve mortalidade operatória. A mortalidade em 30 dias foi de 14,3% (dois casos. A fração de ejeção apresentou aumento significativo após o 7º pós-operatório e o gradiente aórtico apresentou redução significativa. A insuficiência aórtica residual não esteve presente. Não ocorreu complicação vascular periférica ou bloqueio atrioventricular total. CONCLUSÕES: O implante "valve-in-valve" de valva aórtica transcateter em biopróteses com disfunção é um procedimento seguro e com morbimortalidade baixa. Essa possibilidade poderá alterar a indicação de seleção de prótese no procedimento inicial, favorecendo próteses biológicas.OBJECTIVE: Aortic valve replacement for bioprosthesis dysfunction is a procedure involving considerable risk. In some cases, mortality is high and may contraindicate the procedure

  3. Urgent Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis and Acute Heart Failure: Procedural and 30-Day Outcomes.

    Science.gov (United States)

    Landes, Uri; Orvin, Katia; Codner, Pablo; Assali, Abid; Vaknin-Assa, Hana; Schwartznberg, Shmuel; Levi, Amos; Shapira, Yaron; Sagie, Alexander; Kornowski, Ran

    2016-06-01

    Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe symptomatic aortic stenosis (AS) who are at prohibitive/high risk for surgical aortic valve replacement (SAVR). Patients with severe AS may experience acute decompensated heart failure (HF) that is resistant to medical therapy. We report our TAVI experience in treating patients with unstable AS who require urgent intervention for their aortic valve disease. Patients were restrictively included in the urgent TAVI registry if they were admitted with acute refractory and persistent HF despite medical therapy and had TAVI performed during the same hospital stay. All others were included in the elective TAVI group. Between November 2008 and April 2015, 410 consecutive patients underwent TAVI at our centre-27 (6.6%) urgently. Patients operated on urgently were more likely to be frail and carry higher SAVR mortality risk based on The Society of Thoracic Surgeons Predicted Risk of Mortality/logistic EuroSCORE (LES) measures. Pulmonary edema was the most common clinical presentation. Preprocedural assessment used fewer imaging modalities, yet implantation success remained high and reached 96.3% using an additional valve (valve-within-valve) required in 3 patients, with no difference in periprocedural complications according to the Valve Academic Research Consortium-2 definitions. Although 30-day functional capacity was reduced, patients had similar 30-day mortality and major adverse cardiovascular event rates compared with patients who underwent elective TAVI. Short-term outcome after urgent TAVI appears to be reasonable. For patients with severe AS who experience acute decompensated HF that is recalcitrant to optimal medical therapy and who are at high risk with SAVR, urgent TAVI may be a viable treatment strategy. Larger prospective studies and data on long-term outcomes are needed. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  4. Embolic cerebral insults after transapical aortic valve implantation detected by magnetic resonance imaging.

    Science.gov (United States)

    Arnold, Martin; Schulz-Heise, Susanne; Achenbach, Stephan; Ott, Sabine; Dörfler, Arnd; Ropers, Dieter; Feyrer, Richard; Einhaus, Friedrich; Loders, Sabrina; Mahmoud, Faidi; Roerick, Olaf; Daniel, Werner G; Weyand, Michael; Ensminger, Stephan M; Ludwig, Josef

    2010-11-01

    This study assessed the rate of periprocedural embolic ischemic brain injury during transapical aortic valve replacement in 25 consecutive patients. Transcatheter aortic valve implantation is rapidly being established as a new therapeutic approach for aortic valve stenosis. Although initial clinical results are promising, it is unknown whether mobilization and embolization of calcified particles may lead to cerebral ischemia. Twenty-five consecutive patients (10 men, 15 women, mean age: 81 ± 5 years, mean log EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 32 ± 10%) scheduled for transapical aortic valve implantation were included. All patients received a baseline cerebral magnetic resonance imaging scan. The scan was repeated approximately 6 days after valve implantation. The magnetic resonance imaging studies included axial diffusion-weighted, T(2)-weighted, fluid attenuated inversion recovery-weighted, and T(2) gradient echo sequences. Standardized assessment of the neurologic status was performed before aortic valve replacement and post-operatively. Transapical aortic valve implantation was successfully performed in all patients. In 17 patients (68%), new cerebral lesions could be detected, whereas 8 patients showed no new cerebral insults. The pattern of distribution and morphology were typical of embolic origin. Despite the high incidence of morphologically detectable lesions, only 5 patients showed clinical neurologic alterations. Out of these patients, only 1 suffered from a permanent stroke. New embolic ischemic cerebral insults are detected in 68% of patients after transapical valve implantation. Clinical symptoms are rare and usually transitory. Larger trials will need to establish the clinical significance of asymptomatic ischemic lesions as well as the rate of ischemic events in patients undergoing transfemoral valve replacement. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights

  5. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR.

    Science.gov (United States)

    Maeno, Yoshio; Abramowitz, Yigal; Kawamori, Hiroyuki; Kazuno, Yoshio; Kubo, Shunsuke; Takahashi, Nobuyuki; Mangat, Geeteshwar; Okuyama, Kazuaki; Kashif, Mohammad; Chakravarty, Tarun; Nakamura, Mamoo; Cheng, Wen; Friedman, John; Berman, Daniel; Makkar, Raj R; Jilaihawi, Hasan

    2017-10-01

    This study sought to develop a robust and definitive risk model for new permanent pacemaker implantation (PPMI) after SAPIEN 3 (third generation balloon expandable valve) (Edwards Lifesciences, Irvine, California) transcatheter aortic valve replacement (third generation balloon expandable valve TAVR), including calcification in the aortic-valvular complex (AVC). The association between calcium in the AVC and need for PPMI is poorly delineated after third generation balloon expandable valve TAVR. At Cedars-Sinai Heart Institute in Los Angeles, California, a total of 240 patients with severe aortic stenosis underwent third generation balloon expandable valve TAVR and had contrast computed tomography. AVC was characterized precisely by leaflet sector and region. The total new PPMI rate was 14.6%. On multivariate analysis for predictors of PPMI, pre-procedure third generation balloon expandable valve TAVR, right bundle branch block (RBBB), shorter membranous septum (MS) length, and noncoronary cusp device-landing zone calcium volume (NCC-DLZ CA) were included. Predictive probabilities were generated using this logistic regression model. If 3 pre-procedural risk factors were present, the c-statistic of the model for PPMI was area under the curve of 0.88, sensitivity of 77.1%, and specificity of 87.1%; this risk model had high negative predictive value (95.7%). The addition of the procedural factor of device depth to the model, with the parameter of difference between implantation depth and MS length, combined with RBBB and NCC-DLZ CA increased the c-statistic to 0.92, sensitivity to 94.3%, specificity to 83.8%, and negative predictive value to 98.8% CONCLUSIONS: By using a precise characterization of distribution of calcification in the AVC in a single-center, retrospective study, NCC-DLZ CA was found to be an independent predictor of new PPMI post-third generation balloon expandable valve TAVR. The findings also reinforce the importance of short MS length, pre

  6. Transcatheter aortic valve implantation in degenerative sutureless perceval aortic bioprosthesis.

    Science.gov (United States)

    Landes, Uri; Sagie, Alexander; Kornowski, Ran

    2016-10-03

    Sutureless aortic bioprostheses (SAB) are increasingly being used to provide shorter cross-clamp time. Valve-in-valve transcatheter aortic valve replacement (VIV-A) is shown to be effective and safe in the vast majority of patients with degenerated bioprosthetics, yet its' use in SAB failure is infrequent. We present a case of balloon-expandable VIV-A in an 80-year-old woman who suffered severe symptomatic aortic regurgitation in a failed Perceval S 21-mm valve. Computed tomography scan demonstrated a deformed valve. Our heart team favored a percutaneous VIV-A over reoperation due to the patients' high surgical risk. An Edwards-Sapien XT 23 mm was successfully deployed with excellent results. The patient remained asymptomatic following 6 months. As other bioprosthesis, some sutureless valves are condemned to structural valve degeneration. Because VIV-A is being established for managing degenerative bioprosthesis in high risk patients, it is cardinal to identify its role in novel degenerative sutureless valves. SAB were introduced to the clinical market only 5-7 years ago. The absence of sutures may theoretically impose risk for valve instability when adding a transcatheter sutureless valve inside the first one. Our successful experience was very reassuring. We report its feasibility because we believe it should provide support for further investigation on VIV-A within novel SAV. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  7. CMR assessment after a transapical-transcatheter aortic valve implantation

    Energy Technology Data Exchange (ETDEWEB)

    Biere, Loïc, E-mail: lobiere@chu-angers.fr [L’UNAM Université, Angers (France); Université d’Angers, Laboratoire Cardioprotection, Remodelage et Thrombose, CHU d’Angers, Service de Cardiologie, Angers (France); Pinaud, Frédéric [L’UNAM Université, Angers (France); Université d’Angers, CHU d’Angers, Service de Chirurgie Cardio-vasculaire et Thoracique, Angers (France); UMR-CNRS 6214, INSERM 1083, faculté de médecine, Angers (France); Delépine, Stéphane; Grall, Sylvain; Viot, Nathalie; Mateus, Victor; Rouleau, Frédéric [L’UNAM Université, Angers (France); Université d’Angers, Laboratoire Cardioprotection, Remodelage et Thrombose, CHU d’Angers, Service de Cardiologie, Angers (France); Corbeau, Jean-Jacques [Université d’Angers, CHU d’Angers, Département d’anesthésie-réanimation, Angers (France); Prunier, Fabrice [L’UNAM Université, Angers (France); Université d’Angers, Laboratoire Cardioprotection, Remodelage et Thrombose, CHU d’Angers, Service de Cardiologie, Angers (France); and others

    2014-02-15

    Aims: To describe the time course of myocardial scarring after transapical-transcatheter aortic valve implantation (TA-TAVI) with the Edwards SAPIEN XT™ and the Edwards SAPIEN™ prosthesis in a 3-month follow-up study using cardiac magnetic resonance imaging (CMR). Methods: In 20 TA-TAVI patients, CMR was performed at discharge and 3 months (3M). Cine-MRI was used for left ventricular (LV) functional assessment, and late gadolinium enhancement (LGE) imaging was employed for detecting the presence of myocardial scarring. Special attention was given to any artifacts caused by the prosthesis, which were consequently defined using a three-grade artifact scale. Results: We systematically reported the presence of small LGE hyperintensity relating to the apical segment, with no variation found between discharge and 3 M (2.8 ± 1.6 g vs. 2.35 ± 1.1 g). LV ejection fraction, end-diastolic, and end-systolic volumes did not significantly vary. A small area of apical akinesia was observed, with no improvement at follow-up. Whereas the Edwards SAPIEN XT™ prosthesis and the Edwards SAPIEN™ prosthesis are both constituted by metallic stenting structure, the Edwards SAPIEN™ was responsible for a larger signal void, thus potentially limiting the diagnostic performance of CMR. Conclusions: CMR may be performed safely in the context of TA-TAVI. The presence of a very small apical infarction correlating with focal akinesia was observed. As expected, the Edwards SAPIEN XT™ prosthesis was shown to be particularly suitable for CMR assessment.

  8. Platelet reactivity in patients undergoing transcatheter aortic valve implantation.

    Science.gov (United States)

    Orvin, Katia; Eisen, Alon; Perl, Leor; Zemer-Wassercug, Noa; Codner, Pablo; Assali, Abid; Vaknin-Assa, Hana; Lev, Eli I; Kornowski, Ran

    2016-07-01

    Thromboembolic events, primarily stroke, might complicate transcatheter aortic-valve implantation (TAVI) procedures in 3-5 % of cases. Thus, it is common to administer aspirin and clopidogrel pharmacotherapy for 3-6 months following TAVI in order to prevent those events. The biologic response to the dual anti platelet treatment (DAPT) is heterogeneous, e.g. low response, known as high on treatment platelet reactivity (HTPR) may be associated with adverse thromboembolic events. Little is known about the prevalence of HTPR among patients undergoing TAVI. To assess the variability in response and rates of residual platelet reactivity in patients undergoing TAVI. We examined platelet reactivity in response to clopidogrel and aspirin in 40 consecutive patients (mean age 81.7 ± 6.5 years, 66.7 % women) who underwent successful TAVI using the VerifyNow P2Y12 assay and the multiple electrode aggregometry assay (Multiplate analyzer) in response to adenosine diphosphate and arachidonic acid respectively, at different time points before and following TAVI. Before TAVI, the majority of patients were on antiplatelet therapy (68.5 % aspirin, 12.5 % clopidogrel, 12.5 % DAPT). Following the procedure all patients were on DAPT or clopidogrel and warfarin. Among analyzed patients, 41 % had HTPR for clopidogrel and 12.5 % for aspirin at baseline, which did not significantly change 1-month following the procedure (p = 0.81 and p  = 0.33, respectively). In conclusion, patients undergoing TAVI for severe aortic stenosis and treated with DAPT have high rates of residual platelet reactivity during the peri-procedural period and up to 1-month thereafter. These findings may have clinical implications for the anti-platelet management of TAVI patients.

  9. Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk

    Directory of Open Access Journals (Sweden)

    Juan Mieres

    2015-01-01

    Full Text Available Transcatheter Aortic Valve Replacement (TAVR is performed in patients who are poor surgical candidates. Many patients have inadequate femoral access, and alternative access sites have been used such as the transapical approach discussed in this paper. We present an elderly and fragile patient not suitable for surgery for unacceptable high risk, including poor ventricular function, previous myocardial infarction with percutaneous coronary intervention, pericardial effusion, and previous cardiac surgery with replacement of mechanical mitral valve. Transapical aortic valve replacement with a second-generation self-expanding JenaValve is performed. The JenaValve is a second-generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. We discuss transapical access, implantation technique, and feasibility of valve implantation in this extremely high surgical risk patient.

  10. Mitral implant of the Inovare transcatheter heart valve in failed surgical bioprostheses: a novel alternative for valve-in-valve procedures.

    Science.gov (United States)

    Gaia, Diego Felipe; Braz, Ademir Massarico; Simonato, Matheus; Dvir, Danny; Breda, João Roberto; Ribeiro, Gustavo Calado; Ferreira, Carolina Baeta; Souza, José Augusto Marcondes; Buffolo, Enio; Palma, José Honório

    2017-04-01

    Reoperative procedure for the treatment of a failed mitral bioprosthesis is associated with considerable risk. In some cases, mortality is high and might contraindicate the benefit of the procedure. The minimally invasive valve-in-valve (ViV) transcatheter mitral valve implant offers an alternative less-invasive approach, reducing morbidity and mortality. The objective of this paper was to evaluate the mitral ViV approach using the Braile Inovare prosthesis. The transcatheter balloon-expandable Braile Inovare prosthesis was used in 12 cases. Procedures were performed in a hybrid operating room, under fluoroscopic and echocardiographic control. Through left minithoracotomy, the prostheses were implanted through the cardiac apex. Serial echocardiographic and clinical examinations were performed. Follow-up varied from 1 to 30 months. A total of 12 transapical mitral ViV procedures were performed. Patients had a mean age of 61.6 ± 9.9 years and 92% were women. Mean logistic EuroSCORE was 20.1%. Successful valve implantation was possible in all cases. In one case, a right lateral thoracotomy was performed for the removal of an embolized prosthesis. There was no operative mortality. Thirty-day mortality was 8.3%. Ejection fraction was preserved after the implant (66.7%; 64.8%; P  = 0.3). The mitral gradient showed a significant reduction (11 mmHg; 6 mmHg; P  < 0.001). Residual mitral regurgitation was not present. There was no left ventricular outflow tract obstruction. The mitral ViV implant in a failed bioprosthesis is an effective procedure. This possibility might alter prosthesis selection in the future initial surgical prosthesis selection, favouring bioprostheses. Further large trials should explore its safety.

  11. Is valve choice a significant determinant of paravalular leak post-transcatheter aortic valve implantation? A systematic review and meta-analysis.

    LENUS (Irish Health Repository)

    O'Sullivan, Katie E

    2013-11-01

    Paravalvular regurgitation (PVR) following transcatheter aortic valve implantation (TAVI) is associated with poor survival. The two main valve delivery systems used to date differ significantly in both structure and deployment technique. The primary objective of this study was to perform a systematic review and meta-analysis of studies identifying PVR in patients post-TAVI using Medtronic CoreValve (MCV) and Edward Sapien (ES) valves in order to identify whether a significant difference exists between valve types. The secondary objective was to identify additional factors predisposing to PVR to provide an overview of the other associated considerations.

  12. Multicomponent cardiac rehabilitation in patients after transcatheter aortic valve implantation: Predictors of functional and psychocognitive recovery.

    Science.gov (United States)

    Eichler, Sarah; Salzwedel, Annett; Reibis, Rona; Nothroff, Jörg; Harnath, Axel; Schikora, Martin; Butter, Christian; Wegscheider, Karl; Völler, Heinz

    2017-02-01

    Background In the last decade, transcatheter aortic valve implantation has become a promising treatment modality for patients with aortic stenosis and a high surgical risk. Little is known about influencing factors of function and quality of life during multicomponent cardiac rehabilitation. Methods From October 2013 to July 2015, patients with elective transcatheter aortic valve implantation and a subsequent inpatient cardiac rehabilitation were enrolled in the prospective cohort multicentre study. Frailty-Index (including cognition, nutrition, autonomy and mobility), Short Form-12 (SF-12), six-minute walk distance (6MWD) and maximum work load in bicycle ergometry were performed at admission and discharge of cardiac rehabilitation. The relation between patient characteristics and improvements in 6MWD, maximum work load or SF-12 scales were studied univariately and multivariately using regression models. Results One hundred and thirty-six patients (80.6 ± 5.0 years, 47.8% male) were enrolled. 6MWD and maximum work load increased by 56.3 ± 65.3 m ( p < 0.001) and 8.0 ± 14.9 watts ( p < 0.001), respectively. An improvement in SF-12 (physical 2.5 ± 8.7, p = 0.001, mental 3.4 ± 10.2, p = 0.003) could be observed. In multivariate analysis, age and higher education were significantly associated with a reduced 6MWD, whereas cognition and obesity showed a positive predictive value. Higher cognition, nutrition and autonomy positively influenced the physical scale of SF-12. Additionally, the baseline values of SF-12 had an inverse impact on the change during cardiac rehabilitation. Conclusions Cardiac rehabilitation can improve functional capacity as well as quality of life and reduce frailty in patients after transcatheter aortic valve implantation. An individually tailored therapy with special consideration of cognition and nutrition is needed to maintain autonomy and empower octogenarians in coping with challenges of everyday

  13. Expanding TAVI options: elective rotational atherectomy during trans-catheter aortic valve implantation

    Energy Technology Data Exchange (ETDEWEB)

    Piccoli, Anna; Lunardi, Mattia; Ariotti, Sara; Ferrero, Valeria; Vassanelli, Corrado; Ribichini, Flavio, E-mail: flavio.ribichini@univr.it

    2015-01-15

    Summary: Aortic valve stenosis (AVS) in the elderly is frequently associated to coronary artery disease (CAD). In patients with significant coronary stenosis surgical valve replacement is associated to coronary bypass grafting, but whether coronary angioplasty is needed in patients receiving trans-catheter aortic valve implantation (TAVI) is unknown. Given the frequent complexity of CAD in the elderly with calcific AVS, rotational atherectomy (RA) may be needed in some cases. No data are available about feasibility and safety of RA during TAVI. The need for myocardial revascularization in TAVI candidates is discussed, and a series of RA cases performed during TAVI is described.

  14. Transcatheter implantation of a new prototype of self-expanding aortic valve prosthesis: first experience

    Directory of Open Access Journals (Sweden)

    Е. И. Кретов

    2016-12-01

    Full Text Available Calcific aortic stenosis is an aortic valve disease of atherosclerotic origin occurring in 2-4 % of persons older than 65 years, for whom open surgery is contraindicated. Models of self-expanding aortic valves available today have a number of significant drawbacks. The authors have developed a prototype of a new aortic valve and present its first successful implantation in the experiment.Received 17 October 2016. Accepted 22 November 2016.Funding: The study had no sponsorship.Conflict of interest: The authors declare no conflict of interest.

  15. Development of a micro-mechanical valve in a novel glaucoma implant.

    Science.gov (United States)

    Siewert, Stefan; Schultze, Christine; Schmidt, Wolfram; Hinze, Ulf; Chichkov, Boris; Wree, Andreas; Sternberg, Katrin; Allemann, Reto; Guthoff, Rudolf; Schmitz, Klaus-Peter

    2012-10-01

    This paper describes methods for design, manufacturing and characterization of a micro-mechanical valve for a novel glaucoma implant. The implant is designed to drain aqueous humour from the anterior chamber of the eye into the suprachoroidal space in case of an elevated intraocular pressure (IOP). In contrast to any existing glaucoma drainage device (GDD), the valve mechanism is located in the anterior chamber and there, surrounded by aqueous humour, immune to fibrosis induced failure. For the prevention of hypotony the micro-mechanical valve is designed to open if the physiological pressure difference between the anterior chamber and the suprachoroidal space in the range of 0.8 mmHg to 3.7 mmHg is exceeded. In particular the work includes: (i) manufacturing and morphological characterization of polymer tubing, (ii) mechanical material testing as basis for (iii) the design of micro-mechanical valves using finite element analysis (FEA), (iv) manufacturing of microstent prototypes including micro-mechanical valves by femtosecond laser micromachining and (v) the experimental fluid-mechanical characterization of the manufactured microstent prototypes with regard to valve opening pressure. The considered materials polyurethane (PUR) and silicone (SIL) exhibit low elastic modulus and high extensibility. The unique valve design enables a low opening pressure of micro-mechanical valves. An ideal valve design for PUR and SIL with an experimentally determined opening pressure of 2 mmHg and 3.7 mmHg is identified. The presented valve approach is suitable for the inhibition of hypotony as a major limitation of today's GDD and will potentially improve the minimally invasive treatment of glaucoma.

  16. New-Onset Left Bundle Branch Block Induced by Transcutaneous Aortic Valve Implantation.

    Science.gov (United States)

    Massoullié, Grégoire; Bordachar, Pierre; Ellenbogen, Kenneth A; Souteyrand, Géraud; Jean, Frédéric; Combaret, Nicolas; Vorilhon, Charles; Clerfond, Guillaume; Farhat, Mehdi; Ritter, Philippe; Citron, Bernard; Lusson, Jean-R; Motreff, Pascal; Ploux, Sylvain; Eschalier, Romain

    2016-03-01

    New-onset left bundle branch block (LBBB) is a specific concern of transcutaneous aortic valve implantation (TAVI) given its estimated incidence ranging from 5% to 65%. This high rate of occurrence is dependent on the type of device used (size and shape), implantation methods, and patient co-morbidities. The appearance of an LBBB after TAVI reflects a very proximal lesion of the left bundle branch as it exits the bundle of His. At times transient, its persistence can lead to permanent pacemaker implantation in 15% to 20% of cases, most often for high-degree atrioventricular block. The management of LBBB after TAVI is currently not defined by international societies resulting in individual centers developing their own management strategy. The potential consequences of LBBB are dysrhythmias (atrioventricular block, syncope, and sudden death) and functional (heart failure) complications. Prompt postprocedural recognition and management (permanent pacemaker implantation) of patients prevents the occurrence of potential complications and may constitute the preferred approach in this frail and elderly population despite additional costs and complications of cardiac pacing. Moreover, the expansion of future indications for TAVI necessitates better identification of the predictive factors for the development of LBBB. Indeed, long-term right ventricular pacing may potentially increase the risk of developing heart failure in this population. In conclusion, it is thus imperative to not only develop new aortic prostheses with a less-deleterious impact on the conduction system but also to prescribe appropriate pacing modes in this frail population. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Coronary artery disease and symptomatic severe aortic valve stenosis: clinical outcomes after transcatheter aortic valve implantation.

    Directory of Open Access Journals (Sweden)

    Jennifer eMancio

    2015-04-01

    Full Text Available Background: The impact of coronary artery disease (CAD on outcomes after transcatheter aortic valve implantation (TAVI has not been clarified. Furthermore, less is known about the indication and strategy of revascularization in these high risk patients. Aims: This study sought to determine the prevalence and prognostic impact of CAD in patients undergoing TAVI, and to assess the safety and feasibility of percutaneous coronary intervention (PCI before TAVI.Methods: Patients with severe aortic stenosis (AS undergoing TAVI were included into a prospective single centre registry from 2007 to 2012. Clinical outcomes were compared between patients with and without CAD. In some patients with CAD it was decided to perform elective PCI before TAVI after decision by the Heart Team. The primary endpoints were 30-day and 2-year all-cause mortality.Results: A total of 91 consecutive patients with mean age of 79±9 years (52% men underwent TAVI with a median follow-up duration of 16 months (interquartile range of 27.6 months. CAD was present on 46 patients (51%. At 30-day, the incidences of death were similar between CAD and non-CAD patients (9% and 5%, p=0.44, but at 2 years were 50% in CAD patients and 24% in non-CAD patients (crude hazard ratio with CAD, 2.2; 95% confidence interval [CI], 1.1 to 4.6; p=0.04. Adjusting for age, gender, left ventricular ejection fraction and glomerular filtration rate the hazard of death was 2.6-fold higher in patients with CAD (95% CI, 1.1 to 6.0; p=0.03. Elective PCI before TAVI was performed in 13 patients (28% of CAD patients. There were no more adverse events in patients who underwent TAVI+PCI when compared with those who underwent isolated TAVI. Conclusions: In severe symptomatic AS who underwent TAVI, CAD is frequent and adversely impacts long-term outcomes, but not procedure outcomes. In selected patients, PCI before TAVI appears to be feasible and safe.

  18. Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.

    Science.gov (United States)

    Franzoni, Irene; Latib, Azeem; Maisano, Francesco; Costopoulos, Charis; Testa, Luca; Figini, Filippo; Giannini, Francesco; Basavarajaiah, Sandeep; Mussardo, Marco; Slavich, Massimo; Taramasso, Maurizio; Cioni, Micaela; Longoni, Matteo; Ferrarello, Santo; Radinovic, Andrea; Sala, Simone; Ajello, Silvia; Sticchi, Alessandro; Giglio, Manuela; Agricola, Eustachio; Chieffo, Alaide; Montorfano, Matteo; Alfieri, Ottavio; Colombo, Antonio

    2013-08-15

    Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. Transcatheter Aortic Valve Implantation Futility Risk Model Development and Validation Among Treated Patients With Aortic Stenosis.

    Science.gov (United States)

    Zusman, Oren; Kornowski, Ran; Witberg, Guy; Lador, Adi; Orvin, Katia; Levi, Amos; Assali, Abid; Vaknin-Assa, Hana; Sharony, Ram; Shapira, Yaron; Sagie, Alexander; Landes, Uri

    2017-12-15

    Risk-benefit assessment for transcatheter aortic valve implantation (TAVI) is still evolving. A sizeable group of patients do not fully benefit from intervention despite a technically successful procedure. All patients who underwent TAVI with device success and with no Valve Academic Research Consortium (VARC)-2 defined complications were included. Various demographic data, clinical details, and echocardiographic findings were examined. The outcome was defined as 1-year composite of mortality, stroke, lack of functional-class improvement (by New York Heart Association class), and readmissions (≥1 month after the procedure). Logistic regression was used to fit the prediction model. We used a 10-fold cross-validation to validate our results. Of 543 patients, 435 met the inclusion criteria. The mean age was 82 (±6.5) years, 43% were men, and the mean Society of Thoracic Surgeons score was 6.6 (±4.7). At 1 year, 66 of 435 patients (15%) experienced the study end point. The final logistic regression model included diabetes, baseline New York Heart Association functional class, diastolic dysfunction, need for diuretics, mean gradient, hemoglobin level, and creatinine level. The area under the curve was 0.73 and was reduced to 0.71 after validation, with a 97% specificity using a single cutoff. Dividing to low-, medium-, and high-risk groups for futility produced a corresponding prevalence of 6%, 19%, and 59% futility. A web application for the prediction model was developed and provided. In conclusion, this prediction score may provide an important insight and may facilitate identification of patients who, despite a technically successful and uncomplicated procedure, have risk that may outweigh the benefit of a contemplated TAVI. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Computed tomography in the evaluation for transcatheter aortic valve implantation (TAVI)

    Science.gov (United States)

    Hausleiter, Jörg; Achenbach, Stephan; Desai, Milind Y.; Tuzcu, E. Murat

    2011-01-01

    If left untreated, symptomatic, severe aortic stenosis (AS) is associated with a dismal prognosis. Open-heart surgical valve replacement is the treatment of choice and is associated with excellent short and long-term outcome. However, many older patients with multiple co-morbidities and anticipated increased surgical risk are excluded from surgical intervention. For these patients, transcatheter aortic valve implantation (TAVI) is emerging as a viable treatment alternative. Transcatheter valvular heart procedures are characterized by lack of exposure and visualization of the operative field, therefore relying on image guidance, both for patient selection and preparation and the implantation procedure itself. This article describes the role of multi-detector row computed tomography (MDCT) for detailed assessment of the aortic valve, aortic root, and iliac arteries in the context of TAVI. PMID:24282684

  1. Intraocular and extraocular hemorrhage associated with ligature release of non-valved glaucoma drainage implant

    Directory of Open Access Journals (Sweden)

    Michelle Go

    2017-04-01

    Conclusions and importance: This is the first report of a rare occurrence of intraocular and extraocular hemorrhage associated following spontaneous release of ligature of a non-valved glaucoma drainage implant. The presumed mechanism was sudden shallowing of the anterior chamber resulting in the tube irritating uveal vasculature. We do not have an explanation for the extraocular blood.

  2. Bilateral Sturge-Weber Syndrome and glaucoma controlled with Ahmed valve implant

    Directory of Open Access Journals (Sweden)

    Marcelo Jarczun Kac

    2015-02-01

    Full Text Available Sturge-Weber Syndrome is a rare neuro-oculocutaneous disorder. The authors describe the case of a 13 years old boy, presented with bilateral Sturge-Weber Syndrome and glaucoma. Surgical treatment with Ahmed valve implantation in both eyes was carried out achieving lower levels of intraocular pressure.

  3. Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI)

    DEFF Research Database (Denmark)

    Eggebrecht, Holger; Vaquerizo, Beatriz; Moris, Cesar

    2017-01-01

    Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, managemen...

  4. Electrocardiographic imaging-based recognition of possible induced bundle branch blocks during transcatheter aortic valve implantations

    NARCIS (Netherlands)

    Dam, P.M. van; Proniewska, K.; Maugenest, A.M.; Mieghem, N.M. van; Maan, A.C.; Jaegere, P.P. de; Bruining, N.

    2014-01-01

    AIMS: Conventional electrocardiogram (ECG)-based diagnosis of left bundle branch block (LBBB) in patients with left ventricular hypertrophy (LVH) is ambiguous. Left ventricular hypertrophy is often seen in patients with severe aortic stenosis in which a transcatheter aortic valve implantation (TAVI)

  5. Clinical Outcomes and Bioprosthetic Valve Function After Transcatheter Aortic Valve Implantation Under Dual Antiplatelet Therapy vs. Aspirin Alone.

    Science.gov (United States)

    Ichibori, Yasuhiro; Mizote, Isamu; Maeda, Koichi; Onishi, Toshinari; Ohtani, Tomohito; Yamaguchi, Osamu; Torikai, Kei; Kuratani, Toru; Sawa, Yoshiki; Nakatani, Satoshi; Sakata, Yasushi

    2017-02-24

    Dual antiplatelet therapy (DAPT) is commonly used after transcatheter aortic valve implantation (TAVI); however, the supporting evidence is limited. To determine if aspirin alone is a better alternative to DAPT, we compared the outcomes of patients treated with DAPT or aspirin alone after TAVI.Methods and Results:We analyzed a total of 144 consecutive patients (92 females, mean age 83±6 years) who underwent implantation of a balloon-expandable transcatheter valve (SAPIEN or SAPIEN XT, Edwards Lifesciences). Patients were divided into DAPT (n=66) or aspirin-alone treatment groups (n=78). At 1 year after TAVI, the composite endpoint, which consisted of all-cause death, myocardial infarction, stroke, and major or life-threatening bleeding complications, occurred significantly less frequently (Kaplan-Meier analysis) in the aspirin-alone group (15.4%) than in the DAPT group (30.3%; P=0.031). Valve function assessed by echocardiography was similar between the 2 treatment groups with respect to effective orifice area (1.78±0.43 cm2in DAPT vs. 1.91±0.46 cm2in aspirin-alone group; P=0.13) and transvalvular pressure gradient (11.1±3.5 mmHg in DAPT vs. 10.3±4.1 mmHg in aspirin-alone group; P=0.31). Treatment with aspirin alone after TAVI had greater safety benefits and was associated with similar valve function as DAPT. These results suggest that treatment with aspirin alone is an acceptable regimen for TAVI patients.

  6. Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: Feasibility and safety

    Energy Technology Data Exchange (ETDEWEB)

    Fiorina, Claudia, E-mail: clafiorina@yahoo.it [Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia (Italy); Maffeo, Diego; Curello, Salvatore [Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia (Italy); Lipartiti, Felicia [Division of Cardiology, Cardiothoracic Department, Spedali Civili, Brescia (Italy); Chizzola, Giuliano [Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia (Italy); D' Aloia, Antonio [Division of Cardiology, Cardiothoracic Department, Spedali Civili, Brescia (Italy); Adamo, Marianna [Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia (Italy); Mastropierro, Rosy [Division of Cardiothoracic Anestesiology, Cardiothoracic Department, Spedali Civili, Brescia (Italy); Gavazzi, Emanuele [Department of Radiology, University of Brescia, Spedali Civili, Brescia (Italy); Ciccarese, Camilla; Chiari, Ermanna [Division of Cardiology, Cardiothoracic Department, Spedali Civili, Brescia (Italy); Ettori, Federica [Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia (Italy)

    2014-06-15

    Background: Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. Material and Methods: Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. Results: High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85% vs. 64%, p = 0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL ≥2; 9% vs. 33%, p = 0.02). Safety combined end point at 30 days was similar in both groups. Conclusion: Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups.

  7. Computational prediction of mechanical hemolysis in aortic valved protheses

    NARCIS (Netherlands)

    De Tullio, M.D.; Nam, J.; Pascazio, G.; Balaras, E.; Verzicco, Roberto

    2012-01-01

    The paper reports the prediction of mechanical hemolysis by three different models for the case of blood flow through aortic valved prostheses. Two of the adopted models are based on the action of instantaneous shear stress on the blood cells (stress-based), while the third accounts for the finite

  8. Transapical sutureless aortic valve implantation under magnetic resonance imaging guidance: Acute and short-term results.

    Science.gov (United States)

    Horvath, Keith A; Mazilu, Dumitru; Cai, Junfeng; Kindzelski, Bogdan; Li, Ming

    2015-04-01

    Despite the increasing success and applicability of transcatheter aortic valve replacement, 2 critical issues remain: the durability of the valves, and the ideal imaging to aid implantation. This study was designed to investigate the transapical implantation of a device of known durability using real-time magnetic resonance imaging (MRI) guidance. A sutureless aortic valve was used that employs a self-expanding nitinol stent and is amenable to transapical delivery. MRI (1.5-T) was used to identify the anatomic landmarks in 60-kg Yucatan swine. Prostheses were loaded into an MRI-compatible delivery device with an active guidewire to enhance visualization. A series of acute feasibility experiments were conducted (n = 10). Additional animals (n = 6) were allowed to survive and had follow-up MRI scans and echocardiography at 90 days postoperatively. Postmortem gross examination was performed. The valve was MRI compatible and created no significant MRI artifacts. The 3 commissural struts were visible on short-axis view; therefore, coronary ostia obstruction was easily avoided. The average implantation time was 65 seconds. Final results demonstrated stability of the implants with preservation of myocardial perfusion and function over 90 days: the ejection fraction was 48% ± 15%; the peak gradient was 17.3 ± 11.3 mm Hg; the mean gradient was 9.8 ± 7.2 mm Hg. Mild aortic regurgitation was seen in 4 cases, trace in 1 case, and a severe central jet in 1 case. Prosthesis positioning was evaluated during gross examination. We demonstrated that a sutureless aortic valve can be safely and expeditiously implanted through a transapical approach under real-time MRI guidance. Postimplantation results showed a well-functioning prosthesis, with minimal regurgitation, and stability over time. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  9. A Review of the Ahmed Glaucoma Valve Implant and Comparison with Other Surgical Operations.

    Science.gov (United States)

    Riva, Ivano; Roberti, Gloria; Katsanos, Andreas; Oddone, Francesco; Quaranta, Luciano

    2017-04-01

    The Ahmed glaucoma valve (AGV) is a popular glaucoma drainage implant used for the control of intraocular pressure in patients with glaucoma. While in the past AGV implantation was reserved for glaucoma patients poorly controlled after one or more filtration procedures, mounting evidence has recently encouraged its use as a primary surgery in selected cases. AGV has been demonstrated to be safe and effective in reducing intraocular pressure in patients with primary or secondary refractory glaucoma. Compared to other glaucoma surgeries, AGV implantation has shown favorable efficacy and safety. The aim of this article is to review the results of studies directly comparing AGV with other surgical procedures in patients with glaucoma.

  10. TCT-670 Optimal Transcatheter Heart Valve Sizing in Aortic Valve in Valve Implantation: Insights from the Valve in Valve International Data (VIVID) Registry

    DEFF Research Database (Denmark)

    Alnasser, Sami; Cheema, Asim N; Horlick, Eric

    2016-01-01

    )/true ID x 100. Results: A total of 595 patients (359 for standard size and 236 for oversized group) were included in the analysis. Baseline clinical, hemodynamic and surgical valve parameters were similar in these two groups. Both groups used similar THV devices in each matched comparison. The oversized.......1±8.1mmHg vs. 17.4±8.5mmHg, p=0.002) in comparison to the standard cohort. The oversized group however, had a higher rate of moderate to severe AI (6.9% vs. 2.7%, p=0.001) and second THV requirement (5.5%vs. 2.2%, p=0.04). THV mal-positioning, coronary obstruction and postoperative pacemaker requirement...

  11. Hybrid approach combining off-pump CABG with transapical aortic valve implantation via median sternotomy.

    Science.gov (United States)

    Gotte, J M; Rupp, W; Schild, A; Horke, A; Bedda, W; Doll, N

    2012-09-01

    We report the case of a 75-year-old patient diagnosed with severe aortic stenosis and two-vessel coronary artery disease. Due to multiple comorbidities including chronic renal insufficiency, stroke and pulmonary hypertension (EuroSCORE: 34%; STS mortality risk: 14.9%), he was not a candidate for conventional aortic valve surgery. He underwent a novel hybrid treatment approach combining off-pump CABG and transapical aortic valve implantation via a median sternotomy. Extracorporeal circulation could be entirely avoided. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  12. Remotely adjustable check-valves with an electrochemical release mechanism for implantable biomedical microsystem.

    Science.gov (United States)

    Pan, Tingrui; Baldi, Antonio; Ziaie, Babak

    2004-01-01

    We present two remotely adjustable check-valves with an electrochemical release mechanism for implantable biomedical microsystems. Using these valves, one can vary the opening pressure set-point and flow resistance over a period of time. In the first design, an array of remotely addressable valves with a SU-8 structural polymer layer deposited on the top of a gold sacrificial layer act as the micromachined check-valve. In an alternative design, the set point is changed by varying the length of a cantilever-beam. The adjustable cantilever-beam structure is fabricated by gold thermo-compression bond of a thin silicon wafer over a glass substrate. The evaporated gold forms anchors on the silicon and strips on the glass substrate. Adjustment of both microvalves is based on electrochemical dissolution of gold using a constant DC current obtained via a telemetry link. A current density of 35mA/cm/sup 2/ is used to activate the valves. Both gravity and syringe-pump driven flow are used to characterize the valve performance. The multistage fluidic performance (e.g. flow resistance and opening pressure) is clearly demonstrated.

  13. Bentall procedure 39 years after implantation of a Starr-Edwards Aortic Caged- Ball-Valve Prosthesis

    Science.gov (United States)

    2010-01-01

    We report a case of a male patient who received an implantation of a Starr-Edwards-caged-ball-valve-prosthesis in 1967. The surgery and postoperative course were without complications and the patient recovered well after the operation. For the next four decades, the patient remained asymptomatic - no restrictions on his lifestyle and without any complications. In 2006, 39 years after the initial operation, we performed a Bentall-Procedure to treat an aortic ascendens aneurysm with diameters of 6.0 × 6.5 cm: we explanted the old Starr-Edwards-aortic-caged-ball-valve-prosthesis and replaced the ascending aorta with a 29 mm St.Jude Medical aortic-valve-composite-graft and re-implanted the coronary arteries. This case represents the longest time period between Starr-Edwards-caged-ball-valve-prothesis-implantation and Bentall-reoperation, thereby confirming the excellent durability of this valve. PMID:20298579

  14. Bentall procedure 39 years after implantation of a Starr-Edwards Aortic Caged- Ball-Valve Prosthesis

    Directory of Open Access Journals (Sweden)

    Sohns Christian

    2010-03-01

    Full Text Available Abstract We report a case of a male patient who received an implantation of a Starr-Edwards-caged-ball-valve-prosthesis in 1967. The surgery and postoperative course were without complications and the patient recovered well after the operation. For the next four decades, the patient remained asymptomatic - no restrictions on his lifestyle and without any complications. In 2006, 39 years after the initial operation, we performed a Bentall-Procedure to treat an aortic ascendens aneurysm with diameters of 6.0 × 6.5 cm: we explanted the old Starr-Edwards-aortic-caged-ball-valve-prosthesis and replaced the ascending aorta with a 29 mm St.Jude Medical aortic-valve-composite-graft and re-implanted the coronary arteries. This case represents the longest time period between Starr-Edwards-caged-ball-valve-prothesis-implantation and Bentall-reoperation, thereby confirming the excellent durability of this valve.

  15. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2).

    Science.gov (United States)

    Kappetein, Arie Pieter; Head, Stuart J; Généreux, Philippe; Piazza, Nicolo; van Mieghem, Nicolas M; Blackstone, Eugene H; Brott, Thomas G; Cohen, David J; Cutlip, Donald E; van Es, Gerrit-Anne; Hahn, Rebecca T; Kirtane, Ajay J; Krucoff, Mitchell W; Kodali, Susheel; Mack, Michael J; Mehran, Roxana; Rodés-Cabau, Josep; Vranckx, Pascal; Webb, John G; Windecker, Stephan; Serruys, Patrick W; Leon, Martin B

    2012-11-01

    The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for

  16. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

    Science.gov (United States)

    Kappetein, A Pieter; Head, Stuart J; Généreux, Philippe; Piazza, Nicolo; van Mieghem, Nicolas M; Blackstone, Eugene H; Brott, Thomas G; Cohen, David J; Cutlip, Donald E; van Es, Gerrit-Anne; Hahn, Rebecca T; Kirtane, Ajay J; Krucoff, Mitchell W; Kodali, Susheel; Mack, Michael J; Mehran, Roxana; Rodés-Cabau, Josep; Vranckx, Pascal; Webb, John G; Windecker, Stephan; Serruys, Patrick W; Leon, Martin B

    2013-01-01

    The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for

  17. [Percutaneous catheter-based implantation of artificial pulmonary valves in patients with congenital heart defects].

    Science.gov (United States)

    Wyller, Vegard Bruun; Aaberge, Lars; Thaulow, Erik; Døhlen, Gaute

    2011-07-01

    Percutaneous catheter-based implantation of artificial heart valves is a new technique that may supplement surgery and which may be used more in the future. We here report our first experience with implantation of artificial pulmonary valves in children with congenital heart defects. Eligible patients were those with symptoms of heart failure combined with stenosis and/or insufficiency in an established artificial right ventricular outflow tract. The valve was inserted through a catheter from a vein in the groin or neck. Symptoms, echocardiography, invasive measurements and angiography were assessed for evaluation of treatment effect. Our treatment results are reported for the period April 2007-September 2009. Ten patients (seven men and three women, median age 17 years) were assessed. The procedure reduced pressure in the right ventricle (p = 0.008) and resolved the pulmonary insufficiency in all patients. The median time in hospital was two days. No patients had complications that were directly associated with the implantation procedure. One patient developed a pseudoaneurysm in the femoral artery, another had a short-lasting fever two days after the procedure and one patient experienced a stent fracture that required surgery 9 months after the implantation. After 6 months all patients had a reduced pressure gradient in the right ventricular outflow tract (p = 0.008), the pulmonary insufficiency had improved (p = 0.006) and they all reported improval of symptoms. These results persisted for at least 24 months for the four patients who were monitored until then. Percutaneous catheter-based implantation of artificial pulmonary valves improves hemodynamics in the right ventricle of selected patients with congenital heart defects. A randomized controlled study should be undertaken to provide a stronger evidence-base for usefulness of this procedure.

  18. Numerical analysis of the hemodynamic performance of bileaflet mechanical heart valves at different implantation angles.

    Science.gov (United States)

    Kuan, Yee Han; Nguyen, Vinh-Tan; Kabinejadian, Foad; Su, Boyang; Kim, Sangho; Yoganathan, Ajit P; Leo, Hwa Liang

    2014-09-01

    The effects of the implantation angle of bileaflet mechanical heart valves (BMHVs) on the sinus region and downstream flow profiles were investigated. Three-dimensional numerical simulations of BMHVs were performed under physiologic pulsatile flow conditions. The study aim was to examine how the flow fields of different aortic sinus shapes and the downstream aortic arch geometry would be affected by implantation angle. Two geometric models of sinus were investigated: a simplified axisymmetric sinus; and a three-sinus aortic root model, with two different downstream geometries, namely a straight pipe and a simplified curved aortic arch. A 29 mm St. Jude Medical BMHV geometric model was used and positioned at four different angles (0 degrees, 30 degrees, 60 degrees and 90 degrees). The simulation results showed variation in downstream flow profiles at different implantation angles. Generally, at position Z = 1D along the centerline (where Z refers to the axis normal to the x-y plane and D is the inlet diameter), the triple-jet structures were observed with a slight shift of the center jet for three-sinus aortic cases. Apparent differences were observed at position Z = 2D and 4D, such as higher velocity profiles at the inner arch wall. The flow field downstream of the valve implanted at 0 degrees (anatomic position) showed the smallest overall asymmetry at peak systole, while the flow field downstream of the valve implanted at 90 degrees (anti-anatomic position) exhibited high regions of recirculation. Valve orientation was found not to affect the shear stress distribution significantly in the downstream aorta, and this was in agreement with the findings of earlier studies.

  19. Determinants of image quality of rotational angiography for on-line assessment of frame geometry after transcatheter aortic valve implantation

    NARCIS (Netherlands)

    R. Rodríguez-Olivares (Ramón); N. El Faquir (Nahid); Z. Rahhab (Zouhair); A.M. Maugenest; N.M. van Mieghem (Nicolas); C. Schultz (Carl); G. Lauritsch (Guenter); P.P.T. de Jaegere (Peter)

    2016-01-01

    textabstractTo study the determinants of image quality of rotational angiography using dedicated research prototype software for motion compensation without rapid ventricular pacing after the implantation of four commercially available catheter-based valves. Prospective observational study including

  20. A new technique for vascular access management in transcatheter aortic valve implantation.

    Science.gov (United States)

    Sharp, Andrew S P; Michev, Iassen; Maisano, Francesco; Taramasso, Maurizio; Godino, Cosmo; Latib, Azeem; Denti, Paulo; Dorigo, Enrica; Giacomini, Andrea; Iaci, Giuseppe; Manca, Mario; Ielasi, Alfonso; Montorfano, Matteo; Alfieri, Ottavio; Colombo, Antonio

    2010-04-01

    To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. Fifty-two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards-Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards-Sapien) or one (CoreValve). There were serious "on-table" complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure-iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites. (c) 2009 Wiley-Liss, Inc.

  1. Impact of CoreValve size selection based on multi-slice computed tomography on paravalvular leak after transcatheter aortic valve implantation.

    Science.gov (United States)

    Chodór, Piotr; Wilczek, Krzysztof; Przybylski, Roman; Głowacki, Jan; Kukulski, Tomasz; Streb, Witold; Niklewski, Tomasz; Honisz, Grzegorz; Trzeciak, Przemysław; Podolecki, Tomasz; Włoch, Łukasz; Zembala, Marian; Kalarus, Zbigniew

    2017-01-01

    Paravalvular leak (PVL) has significant impact on long-term outcomes in patients after transcatheter aortic valve implantation (TAVI). This study sought to determine whether multi-slice computed tomography (MSCT)-guided valve selection reduces PVL after CoreValve implantation. The analysis encompassed 69 patients implanted with CoreValve and were divided into two groups. In Group I (30 patients), valve selection was based on standard procedures, in Group II (39 patients), on MSCT measurements. Paravalvular leak was assessed with angiography and echocardiography. Multi-slice computed tomography results influenced a change of decision as to the size of the implanted valve in 12 (30.9%) patients in Group II and would have caused the decision to change in 9 (37.5%) patients in Group I. The degree of oversizing in Group I and II was 12.8% ± ± 7.6% vs. 18.6% ± 5.1% (p = 0.0006), respectively. The oversizing among the patients with leak degree of 0-1 and ≥ 2 was 18.1% ± 6.0% and 12.8% ± 7.4% (p = 0.0036). Angiographic assessment indicated post-procedural PVL ≥ 2 in 50% of patients in Group I and 20.5% in Group II (p = 0.01), while echocardiographic assessment indicated the same in 73.3% of patients in Group I and 45.6% in Group II (p = 0.0136). The composite endpoint occurred in 26.6% (8/30) patients in Group I vs. 5.1% (2/39) patients in Group II (p = 0.0118). Selecting the CoreValve device based on MSCT resulted in smaller rates of PVL and less frequent composite endpoint. In 1/3 of patients MSCT led to a change of the valve size. The degree of oversizing had a significant impact on PVL.

  2. Intravitreal bevacizumab and Ahmed glaucoma valve implantation in patients with neovascular glaucoma.

    Science.gov (United States)

    Zhang, Hai-Tao; Yang, Yu-Xin; Xu, Ying-Ying; Yang, Rui-Min; Wang, Bao-Jun; Hu, Jun-Xi

    2014-01-01

    To explore the efficacy of preoperative intravitreal bevacizumab (IVB) injection combined with Ahmed glaucoma valve (AGV) implantation in the treatment of neovascular glaucoma (NVG). This retrospective study included 35 eyes from 35 patients who underwent preoperative IVB and AGV implantation for treatment of NVG. Findings such as intraocular pressure (IOP) number of anti-glaucoma medications, visual acuity (VA), surgical success rates, and complications were recorded. After AGV implantation, IOP was 18.2±4.0 mm Hg, 15.5±3.3 mm Hg and 9.8±2.6 mm Hg at 6, 12 and 36mo, significantly decreased compared with pre-IOP (PAGV implantation should be one of treatments for NVG because of its safety and effectiveness.

  3. Surgical Outcomes of Additional Ahmed Glaucoma Valve Implantation in Refractory Glaucoma.

    Science.gov (United States)

    Ko, Sung Ju; Hwang, Young Hoon; Ahn, Sang Il; Kim, Hwang Ki

    2016-06-01

    To evaluate the surgical outcomes of the implantation of an additional Ahmed glaucoma valve (AGV) into the eyes of patients with refractory glaucoma following previous AGV implantation. This study is a retrospective review of the clinical histories of 23 patients who had undergone a second AGV implantation after a failed initial implantation. Age, sex, prior surgery, glaucoma type, number of medications, intraocular pressure (IOP), visual acuity, and surgical complications were analyzed. Surgical success was defined as IOP maintained below 21 mm Hg, with at least a 20% overall reduction in IOP, regardless of the use of IOP-lowering medications. Following the implantation of a second AGV, the mean IOP decreased from 39.3 to 18.5 mm Hg (52.9% reduction, PAGV implantation (PAGV implantation. None of the patients showed any evidence of diplopia or ocular movement limitation as a result of the presence of 2 AGVs in the same eye. Prior trabeculectomy was found to be a significant risk factor for failure (P=0.027). A second AGV implantation can be a good choice of surgical treatment when the first AGV has failed to control IOP.

  4. Transcatheter aortic-valve implantation with one single minimal contrast media injection.

    Science.gov (United States)

    Arrigo, Mattia; Maisano, Francesco; Haueis, Sabine; Binder, Ronald K; Taramasso, Maurizio; Nietlispach, Fabian

    2015-06-01

    Performing transcatheter aortic valve implantation (TAVI) with the use of minimal contrast in patients at high-risk for acute kidney injury (AKI). Contrast-induced nephropathy (CIN) is a major cause of AKI following TAVI and is associated with increased morbidity and mortality. The amount of contrast media used increases the risk for CIN. Computed tomography was omitted during the screening process. For the procedure transfemoral access was default. The self-expanding CoreValve prosthesis was chosen in all patients to minimize the risk of annular rupture in case of oversizing. Valve sizing was based on echocardiography, aortography, calcification on fluoroscopy, as well as weight and height of the patient. A single contrast injection was performed to confirm correct position of the pigtail catheter at the level of the annulus. The pigtail then served as the marker for the device landing zone. Intraprocedural assessment of the implantation result relied on echocardiography and hemodynamics. Five patients with severe aortic stenosis and at high risk for developing CIN were included. Device success was achieved in all patients and no major complications occurred. The median dose of injected contrast media was 8 ml (4-9). All but one patient had improved renal function after the intervention compared to baseline. Our study shows feasibility of performing TAVI with a single minimal contrast media injection, using a self-expandable valve. This technique has the potential to reduce the incidence of CIN. © 2015 Wiley Periodicals, Inc.

  5. 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis.

    Science.gov (United States)

    Buellesfeld, Lutz; Gerckens, Ulrich; Schuler, Gerhard; Bonan, Raoul; Kovac, Jan; Serruys, Patrick W; Labinaz, Marino; den Heijer, Peter; Mullen, Michael; Tymchak, Wayne; Windecker, Stephan; Mueller, Ralf; Grube, Eberhard

    2011-04-19

    The purpose of this study was to evaluate the safety, device performance, and clinical outcome up to 2 years for patients undergoing transcatheter aortic valve implantation (TAVI). The role of TAVI in the treatment of calcific aortic stenosis evolves rapidly, but mid- and long-term results are scarce. We conducted a prospective, multicenter, single-arm study with symptomatic patients undergoing TAVI for treatment of severe aortic valve stenosis using the 18-F Medtronic CoreValve (Medtronic, Minneapolis, Minnesota) prosthesis. In all, 126 patients (mean age 82 years, 42.9% male, mean logistic European System for Cardiac Operative Risk Evaluation score 23.4%) with severe aortic valve stenosis (mean gradient 46.8 mm Hg) underwent the TAVI procedure. Access was transfemoral in all but 2 cases with subclavian access. Retrospective risk stratification classified 54 patients as moderate surgical risk, 51 patients as high-risk operable, and 21 patients as high-risk inoperable. The overall technical success rate was 83.1%. Thirty-day all-cause mortality was 15.2%, without significant differences in the subgroups. At 2 years, all-cause mortality was 38.1%, with a significant difference between the moderate-risk group and the combined high-risk groups (27.8% vs. 45.8%, p = 0.04). This difference was mainly attributable to an increased risk of noncardiac mortality among patients constituting the high-risk groups. Hemodynamic results remained unchanged during follow-up (mean gradient: 8.5 ± 2.5 mm Hg at 30 days and 9.0 ± 3.4 mm Hg at 2 years). Functional class improved in 80% of patients and remained stable over time. There was no incidence of structural valve deterioration. The TAVI procedure provides sustained clinical and hemodynamic benefits for as long as 2 years for patients with symptomatic severe aortic stenosis at increased risk for surgery. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. Transfemoral transcatheter aortic valve implantation in a patient with a severe aortic stenosis and cardiogenic shock requiring intra-aortic balloon pump support.

    Science.gov (United States)

    Chodór, Piotr; Wilczek, Krzysztof; Przybylski, Roman; Świątkowski, Andrzej; Głowacki, Jan; Kalarus, Zbigniew; Zembala, Marian

    2015-01-01

    The following paper presents a patient with severe aortic stenosis and severely reduced left ventricular ejection fraction with intra-aortic balloon pump counterpulsation support, who underwent transfemoral aortic valve implantation of a CoreValve prosthesis.

  7. The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.

    Science.gov (United States)

    Silaschi, Miriam; Treede, Hendrik; Rastan, Ardawan J; Baumbach, Hardy; Beyersdorf, Friedhelm; Kappert, Utz; Eichinger, Walter; Rüter, Florian; de Kroon, Thomas L; Lange, Rüdiger; Ensminger, Stephan; Wendler, Olaf

    2016-11-01

    Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia

  8. Augmented Reality System for Ultrasound Guidance of Transcatheter Aortic Valve Implantation.

    Science.gov (United States)

    Currie, Maria E; McLeod, A Jonathan; Moore, John T; Chu, Michael W A; Patel, Rajni; Kiaii, Bob; Peters, Terry M

    2016-01-01

    Transcatheter aortic valve implantation (TAVI) relies on fluoroscopy and nephrotoxic contrast medium for valve deployment. We propose an alternative guidance system using augmented reality (AR) and transesophageal echocardiography (TEE) to guide TAVI deployment. The goals of this study were to determine how consistently the aortic valve annulus is defined from TEE using different aortic valve landmarks and to compare AR guidance with fluoroscopic guidance of TAVI deployment in an aortic root model. Magnetic tracking sensors were integrated into the TAVI catheter and TEE probe, allowing these tools to be displayed in an AR environment. Variability in identifying aortic valve commissures and cuspal nadirs was assessed using TEE aortic root images. To compare AR guidance of TAVI deployment with fluoroscopic guidance, a TAVI stent was deployed 10 times in the aortic root model using each of the two guidance systems. Commissures and nadirs were both investigated as features for defining the valve annulus in the AR guidance system. The commissures were identified more consistently than the nadirs, with intraobserver variability of 2.2 and 3.8 mm, respectively, and interobserver variability of 3.3 and 4.7 mm, respectively. The precision of TAVI deployment using fluoroscopic guidance was 3.4 mm, whereas the precision of AR guidance was 2.9 mm, and its overall accuracy was 3.4 mm. This indicates that both have similar performance. Aortic valve commissures can be identified more reliably than cuspal nadirs from TEE. The AR guidance system achieved similar deployment accuracy to that of fluoroscopy while eliminating the use and consequences of nephrotoxic contrast and radiation.

  9. Aortic Valve Gradient and Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis.

    Science.gov (United States)

    Witberg, Guy; Barsheshet, Alon; Assali, Abid; Vaknin-Assa, Hana; Shaul, Aviv A; Orvin, Katia; Vaturi, Moti; Schwartzenberg, Shmuel; Shapira, Yaron; Sagie, Alexander; Kornowski, Ran

    2016-01-01

    To explore the relation between the baseline aortic valve gradient (AVG) as a continuous variable and clinical outcomes following transcatheter aortic valve implantation (TAVI) in general and specifically in patients with high-gradient aortic stenosis (AS). We reviewed 317 consecutive patients who underwent TAVI at our institution. We investigated the relation between AVG as a continuous/categorical variable and outcome among all patients and in patients without low-flow low-gradient AS, using the Cox proportional hazard model adjusting for multiple prognostic variables. Patients had a peak AVG of 79.9 ± 22.8 mm Hg (mean 50.5 ±15.7). During a mean follow-up of 2.7 years, AVG was inversely associated with mortality and mortality or cardiac hospitalization. Every 10-mm-Hg increase in peak AVG was associated with 18% reduction in mortality (p = 0.003) and 19% reduction in mortality/cardiac hospitalization (p 40% or peak AVG >64 mm Hg yielded similar results. Mean and peak baseline AVGs are directly associated with improved outcomes after TAVI; AVG can be used to select the patients most likely to benefit from TAVI. © 2016 S. Karger AG, Basel.

  10. Timing of Onset and Outcome of New Conduction Abnormalities Following Transcatheter Aortic Valve Implantation: Role of Balloon Aortic Valvuloplasty.

    Science.gov (United States)

    Campelo-Parada, Francisco; Nombela-Franco, Luis; Urena, Marina; Regueiro, Ander; Jiménez-Quevedo, Pilar; Del Trigo, María; Chamandi, Chekrallah; Rodríguez-Gabella, Tania; Auffret, Vincent; Abdul-Jawad Altisent, Omar; DeLarochellière, Robert; Paradis, Jean-Michel; Dumont, Eric; Philippon, François; Pérez-Castellano, Nicasio; Puri, Rishi; Macaya, Carlos; Rodés-Cabau, Josep

    2017-05-27

    Little is known about the timing of onset and outcome of conduction abnormalities (CA) following balloon-expandable transcatheter aortic valve implantation. The aim of this study was to examine the timing of CA and determine the impact of balloon aortic valvuloplasty (BAV) on the persistence of these abnormalities. A total of 347 patients were included. Of these, 75 had a continuous electrocardiogram recording and a 6-lead electrocardiogram at each step of the procedure. In the transcatheter aortic valve implantation population undergoing continuous electrocardiogram monitoring, new-onset left bundle branch block (LBBB) or third-degree atrioventricular block occurred in 48 (64%) and 16 (21.3%) patients, with 51.5% of CA occurring before valve implantation. Left bundle branch block persisted more frequently at hospital discharge (53.8 vs 22.7%; P=.028) and at 1-month follow-up (38.5 vs 13.6%; P=.054) when occurring before valve implantation. Balloon aortic valvuloplasty prior to valve implantation was used in 264 (76.1%) patients, and 78 (22.5%) had persistent LBBB or complete atrioventricular block requiring pacemaker implantation. Persistent LBBB or unresolved atrioventricular block at 1 month occurred more frequently in the BAV group (76.1 vs 47.6%; P=.021), and the use of BAV was associated with a lack of CA resolution (OR, 3.5; 95%CI, 1.17-10.43; P=.021). In patients undergoing a balloon-expandable transcatheter aortic valve implantation, more than half of CA occurred before valve implantation. Early occurrence of CA was associated with a higher rate of persistence at 1-month follow-up. The use of BAV was associated with an increased risk of CA persistence. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  11. Predicting Acute Kidney Injury Following Mitral Valve Repair.

    Science.gov (United States)

    Chang, Chih-Hsiang; Lee, Cheng-Chia; Chen, Shao-Wei; Fan, Pei-Chun; Chen, Yung-Chang; Chang, Su-Wei; Chen, Tien-Hsing; Wu, Victor Chien-Chia; Lin, Pyng-Jing; Tsai, Feng-Chun

    2016-01-01

    Acute kidney injury (AKI) after cardiac surgery is associated with short-term and long-term adverse outcomes. Novel biomarkers have been identified for the early detection of AKI; however, examining these in every patient who undergoes cardiac surgery is prohibitively expensive. Society of Thoracic Surgeons (STS) and Age, Creatinine, and Ejection Fraction (ACEF) scores have been proven to predict mortality in bypass surgery. The aim of this study was to determine whether these scores can be used to predict AKI after mitral valve repair. Between January 2010 and December 2013, 196 patients who underwent mitral valve repair were enrolled. The clinical characteristics, outcomes, and scores of prognostic models were collected. The primary outcome was postoperative AKI, defined using the Kidney Disease Improving Global Outcome 2012 clinical practice guidelines for AKI. A total of 76 patients (38.7%) developed postoperative AKI. The STS renal failure (AUROC: 0.797, P < .001) and ACEF scores (AUROC: 0.758, P < .001) are both satisfactory tools for predicting all AKI. The STS renal failure score exhibited superior accuracy compared with the ACEF score in predicting AKI stage 2 and 3. The overall accuracy of both scores was similar for all AKI and AKI stage 2 and 3 when the cut-off points of the STS renal failure and ACEF scores were 2.2 and 1.1, respectively. In conclusion, the STS renal failure score can be used to accurately predict stage 2 and 3 AKI after mitral valve repair. The ACEF score is a simple tool with satisfactory power in screening patients at risk of all AKI stages. Additional studies can aim to determine the clinical implications of combining preoperative risk stratification and novel biomarkers.

  12. Transcatheter heart valve in valve implantation with Edwards SAPIEN bioprosthetic valve for different degenerated bioprosthetic valve positions (First Iranian ViV report with mid-term follow up

    Directory of Open Access Journals (Sweden)

    Ali Mohammad Haji Zeinali

    2017-09-01

    Conclusion: As the first Iranian all-comers case series with midterm follow up for ViV implantation, we had no mortality. Interestingly none of our patients had neurologic sequelae after the procedure. Midterm follow up for our patients was acceptable with good functional class and appropriate echocardiographic findings. Due to high surgical risk of the redo procedure after failing of a bioprosthetic valve especially in elderly patients with comorbidities, ViV implantation would be a good alternative to surgery for this high risk group.

  13. Implantation of transcatheter aortic valve prosthesis through the ascending aorta concomitant with coronary artery bypass grafting without cardiopulmonary bypass

    Directory of Open Access Journals (Sweden)

    João Carlos Ferreira Leal

    2014-12-01

    Full Text Available Introdution: The transcatheter aortic valve implantation in the treatment of high-risk symptomatic aortic stenosis has increased the number of implants every year. The learning curve for transcatheter aortic valve implantation has improved since the last 12 years, allowing access alternatives. Objective: The aim of this study is to approach the implantation of transcatheter aortic valve through transaortic via associated with off-pump cardiopulmonary bypass surgery in a 67-year-old man, with chronic obstructive pulmonary disease, arterial hypertension and kidney transplant. Methods: Off-pump coronary artery bypass surgery was performed and the valve in the aortic position was released successfully. Results: There were no complications in the intraoperative and postoperative period. Gradient reduction, effective orifice increasing of the prosthesis and absence of valvular regurgitation after implantation were observed by transesophageal echocardiography. Conclusion: Procedural success demonstrates that implantation of transcatheter aortic valve through the ascending aorta associated with coronary artery bypass surgery without CPB is a new option for these patients.

  14. Combined extracapsular cataract extraction with ahmed glaucoma valve implantation in phacomorphic glaucoma

    Directory of Open Access Journals (Sweden)

    Das Jaya

    2002-01-01

    Full Text Available Purpose: To report a retrospective analysis of a combined procedure of extracapsular cataract extraction (ECCE with heparin surface modified (HSM posterior chamber intraocular lens (PCIOL implantation along with primary Ahmed glaucoma valve (AGV implantation in an attempt to optimize visual acuity gains and intraocular pressure (IOP control in patients with phacomorphic glaucoma. Methods: ECCE with HSM PC IOL and AGV implantation was performed through two separate incisions in 15 patients diagnosed with phacomorphic glaucoma. Postoperative improvement in visual acuity and IOP control were monitored. Results: A steady control of IOP was maintained in all patients with minimum anti-glaucoma medications. The average visual acuity was approximately 6/24 at 3 months. Conclusion: Superior preoperative IOP control and a shorter phacomorphic attack resulted in better postoperative vision. The successful maintenance of IOP within the desired range in this study suggests that the procedure should be performed under similar conditions.

  15. Polymeric heart valves for surgical implantation, catheter-based technologies and heart assist devices.

    Science.gov (United States)

    Bezuidenhout, Deon; Williams, David F; Zilla, Peter

    2015-01-01

    Efficient function and long-term durability without the need for anticoagulation, coupled with the ability to be accommodated in many different types of patient, are the principal requirements of replacement heart valves. Although the clinical use of valves appeared to have remained steady for several decades, the evolving demands for the elderly and frail patients typically encountered in the developed world, and the needs of much younger and poorer rheumatic heart disease patients in the developing world have now necessitated new paradigms for heart valve technologies and associated materials. This includes further consideration of durable elastomeric materials. The use of polymers to produce flexible leaflet valves that have the benefits of current commercial bioprosthetic and mechanical valves without any of their deficiencies has been held desirable since the mid 1950s. Much attention has been focused on thermoplastic polyurethanes in view of their generally good physico-chemical properties and versatility in processing, coupled with the improving biocompatibility and stability of recent formulations. Accelerated in vitro durability of between 600 and 1000 million cycles has been achieved using polycarbonate urethanes, and good resistance to degradation, calcification and thrombosis in vivo has been shown with some polysiloxane-based polyurethanes. Nevertheless, polymeric valves have remained relegated to use in temporary ventricular assist devices for bridging heart failure patients to transplantation. Some recent studies suggest that there is a greater degree of instability in thermoplastic materials than hitherto believed so that significant challenges remain in the search for the combination of durability and biocompatibility that would allow polymeric valves to become a clinical reality for surgical implantation. Perhaps more importantly, they could become candidates for use in situations where minimally invasive transcatheter procedures are used to

  16. Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the medtronic corevalve system: The CoreValve prospective, international, post-market ADVANCE-II study

    NARCIS (Netherlands)

    A.S. Petronio (Anna S.); J.-M. Sinning (Jan-Malte); N.M. van Mieghem (Nicolas); G. Zucchelli (Giulio); G. Nickenig (Georg); R. Bekeredjian (Raffi); J. Bosmans (Johan); F. Bedogni (Francesco); M. Branny (Marian); K. Stangl (Karl); J. Kovac (Jan); M. Schiltgen (Molly); S. Kraus (Stacia); P.P.T. de Jaegere (Peter)

    2015-01-01

    textabstractObjectives The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis,

  17. PREDICTION OF BLOOD FLOW VELOCITY AND LEAFLET DEFORMATION VIA 2D MITRAL VALVE MODEL

    Directory of Open Access Journals (Sweden)

    M.A.H. Mohd Adib

    2012-06-01

    Full Text Available In the mitral valve, regional variations in structure and material properties combine to affect the biomechanics of the entire valve. From previous studies, we know that the mitral valve leaflet tissue is highly extensible. A two-dimensional model of the mitral valve was generated using an Arbitrary Lagrangian-Eulerian (ALE mesh. A simple approximation of the heart geometry was used and the valve dimensions were based on actual measurements made. Valve opening and closure was simulated using contact equations. The objective of this study was to investigate and predict flow and leaflet phenomena via a simple 2D mitral valve model based on the critical parameter of blood. Two stages of mitral valves analysis were investigated: the systolic and diastolic stages. The results show a linear correlation between the mitral valve leaflet rigidity and the volume of backflow. Additionally, the simulation predicted mitral valve leaflet displacement during closure, which agreed with the results of our previous data analysis and the results for blood flow velocity during systole condition through the mitral valve outlet, as reported in the medical literature. In conclusion, these computational techniques are very useful in the study of both degenerative valve disease and failure of prostheses and will be further developed to investigate heart valve failure and subsequent surgical repair.

  18. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System®: The Rotterdam experience

    NARCIS (Netherlands)

    N.M. van Mieghem (Nicolas); R-J.M. Nuis (Rutger-Jan); N. Piazza (Nicolo); A. Tzikas (Apostolos); J.M.R. Ligthart (Jürgen); C.J. Schultz (Carl); P.P.T. de Jaegere (Peter); P.W.J.C. Serruys (Patrick)

    2010-01-01

    textabstractAims: Transcatheter aortic valve implantation (TAVI) requires large bore catheters. Access site complications, therefore, can be a concern. The aim of this study is to present the 30-day incidence of major and minor vascular complications in patients treated with the third generation 18

  19. Initial Experiences of Transcatheter Aortic Valve Implantation (TAVI in Iran with Midterm Follow up

    Directory of Open Access Journals (Sweden)

    Ali Mohammad Haji Zeinali

    2017-09-01

    Full Text Available Background: Surgical Aortic Valve Replacement (SAVR is the gold standard method for treatment of symptomatic severe senile Aortic Valve Stenosis (AS. For inoperable patients, due to severe co-morbidities, Transcatheter Aortic Valve Implantation (TAVI has been suggested as a new and safe alternative with significant follow up superiority to medical treatment; recently, it was suggested for patients at intermediate risk, as well. Since its introduction in 2002, TAVI has well developed in more than 40 countries. Objectives: We made an attempt to transfer this technology to Tehran University for the first time and then evaluated the feasibility and safety of this new technique with midterm closed clinical and echocardiographic follow up. Patients and Methods: Eight patients (5 males, with a mean age of 77 ± 6.7 years old underwent transfemoral TAVI from 2010, as the first sequential patients in Tehran University, by Balloon expandable bioprosthetic Edwards SAPIEN transcatheter heart valve, under general anesthesia in hybrid operation room. Results: There were 7 tricuspid valves and one bicuspid aortic valve (AV. All the patients had symptomatic severe senile valvular AS with severe co-morbidities so that the surgeons did not agree with open SAVR. Closed preprocedural, procedural, in hospital, one and 6 months clinical and echocardiographic assessments and follow up were done. Results: Procedural success rate was 100% with good implantation of the valve. A decrease in the AV mean gradient (MG from preprocedural mean AVMG 52.2 ± 19.7 mm Hg to 9.8 ± 3.7 mm Hg was observed in the 6 month follow up. One patient had procedural papillary muscle damage and moderate mitral regurgitation (MR, which needed hemodynamic support. No in hospital mortality or major complications were seen. In the follow up period, one patient had unexplained sudden death in sleep 3 weeks after the discharge. The other 7 patients had good 6 months of follow up with improvement of

  20. Outcomes of Ahmed glaucoma valve implantation in children with primary congenital glaucoma.

    Science.gov (United States)

    Ou, Yvonne; Yu, Fei; Law, Simon K; Coleman, Anne L; Caprioli, Joseph

    2009-11-01

    To evaluate the long-term efficacy of intraocular pressure reduction and complications of Ahmed glaucoma valve (AGV) implantation in children with primary congenital glaucoma. The medical records of patients with primary congenital glaucoma who underwent AGV implantation with a minimum follow-up of 6 months were reviewed. The primary outcome measure was cumulative probability of success, defined as intraocular pressure greater than 5 mm Hg and less than 23 mm Hg and at least a 15% reduction from the preoperative intraocular pressure, without serious complications, additional glaucoma surgery, or loss of light perception. Thirty eyes of 19 children with primary congenital glaucoma who underwent AGV implantation with a minimum follow-up of 6 months were reviewed. The children had a mean (SD) age of 1.8 (2.6) years, a mean (SD) preoperative intraocular pressure of 28.4 (6.7) mm Hg, and a mean (SD) follow-up time of 57.6 (48.0) months. The cumulative probability of success was 63% in 1 year and 33% in 5 years. After a second AGV implantation, the cumulative probability of success was 86% in 1 and 2 years and 69% in 5 years. Hispanic ethnicity (P = .02) and being female (P = .005) were associated with increased risk of failure. Thirty-three percent of AGV implantations in children with primary congenital glaucoma were successful after 5 years of follow-up. With the implantation of a second AGV, the 5-year success rate increased to 69%.

  1. Introducing transcatheter aortic valve implantation with a?new generation prosthesis: Institutional learning curve and effects on acute outcomes

    OpenAIRE

    D'Ancona, G; Agma, H. U.; Kische, S.; El-Achkar, G.; Di?mann, M.; Ortak, J.; Ince, H.; U. Ketterer; B?risch, A.; ?ner, A.

    2016-01-01

    Objectives We present our single-centre experience with the direct flow medical (DFM) trans-catheter aortic valve implantation (TAVI) prosthesis addressing the impact of learning curve upon outcomes. Background The DFM has been recently introduced for TAVI. The prosthesis presents original design and implantation features. Methods Patients were divided into three groups according to the chronological implantation sequence that reflected technical skills acquisition of the entire team. Results...

  2. Remotely adjustable check-valves with an electrochemical release mechanism for implantable biomedical microsystems.

    Science.gov (United States)

    Pan, Tingrui; Baldi, Antonio; Ziaie, Babak

    2007-06-01

    In this paper, we present two remotely adjustable check-valves with an electrochemical release mechanism for implantable biomedical microsystems. These valves allow one to vary the opening pressure set-point and flow resistance over a period of time. The first design consists of a micromachined check-valve array using a SU-8 polymer structural layer deposited on the top of a gold sacrificial layer. The second design is based on a variable length cantilever beam structure with a gold sacrificial layer. The adjustable cantilever-beam structure is fabricated by gold thermo-compression bond of a thin silicon wafer over a glass substrate. In both designs, the evaporated gold can be electrochemically dissolved using a constant DC current via a telemetry link. In the first design the dissolution simply opens up individual outlets, while in the second design, gold anchors are sequentially dissolved hence increasing the effective length of the cantilever beam (reducing the opening pressure). A current density of 35 mA/cm(2) is used to dissolve the gold sacrificial layers. Both gravity and syringe-pump driven flow are used to characterize the valve performance. A multi-stage fluidic performance (e.g. flow resistance and opening pressure) is clearly demonstrated.

  3. Percutaneous pulmonary valve implantation – state of the art and Polish experience

    Directory of Open Access Journals (Sweden)

    Elżbieta K. Biernacka

    2017-03-01

    Full Text Available Percutaneous pulmonary valve implantation (PPVI is a relatively new method of treating patients with right ventricular outflow tract (RVOT dysfunction after surgical repair of congenital heart disease. Since its introduction in 2000 by Bonhoeffer, more than ten thousand PPVI procedures have been performed worldwide. Indications for PPVI have been adapted from those accepted for surgical intervention. Two types of valves are being used: Melody Medtronic available in diameters 16 mm and 18 mm and the family of Edwards SAPIEN valves 23, 26 and 29. The procedure has been shown to be feasible and safe when performed in patients with full pulmonary conduit dysfunction and in selected cases of patched RVOT. The low complication rate and the reduced number of open-chest re-interventions over a patient’s lifetime are among the main advantages of the procedure. The most important problem responsible for late mortality and reinterventions is infective endocarditis. Size restrictions of the currently available valves limit deployment in the majority of patients with a wide RVOT. Newer devices are being developed to make these patients suitable for PPVI. A literature review, Polish experience and results of PPVI performed in 66 patients in the Institute of Cardiology in Warsaw are briefly reported.

  4. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis

    DEFF Research Database (Denmark)

    Siontis, George C M; Praz, Fabien; Pilgrim, Thomas

    2016-01-01

    undergoing transfemoral access [0.80 (0.69-0.93); P = 0.004], but not transthoracic access [1.17 (0.88-1.56); P = 0.293] (Pinteraction = 0.024) and in female [0.68 (0.50-0.91); P = 0.010], but not male patients [0.99 (0.77-1.28); P = 0.952] (Pinteraction = 0.050). Secondary outcomes of kidney injury, new......-onset atrial fibrillation, and major bleeding favoured TAVI, while major vascular complications, incidence of permanent pacemaker implantation, and paravalvular regurgitation favoured SAVR. CONCLUSION: Compared with SAVR, TAVI is associated with a significant survival benefit throughout 2 years of follow...

  5. The role of balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation.

    Science.gov (United States)

    Wacławski, Jacek; Wilczek, Krzysztof; Pres, Damian; Krajewski, Adam; Poloński, Lech; Zembala, Marian; Gąsior, Mariusz

    2015-03-01

    Balloon aortic valvuloplasty is recommended in patients not suitable for transcatheter aortic valve implantation/aortic valve replacement (TAVI/AVR) or when such interventions are temporarily contraindicated. The number of performed balloon aortic valvuloplasty (BAV) procedures has been increasing in recent years. Valvuloplasty enables the selection of individuals with severe left ventricular dysfunction or with symptoms of uncertain origin resulting from concomitant disorders (including chronic obstructive pulmonary disease [COPD]) who can benefit from destination therapy (AVR/TAVI). Thanks to improved equipment, the number of adverse effects is now lower than it was in the first years after the advent of BAV. Valvuloplasty can be safely performed even in unstable patients, but long-term results remain poor. In view of the limited availability of TAVI in Poland, it is reasonable to qualify patients for BAV more often, as it is a relatively safe procedure improving the clinical condition of patients awaiting AVR/TAVI.

  6. [Transcatheter aortic valve implantation versus aortic valve replacement: cost analysis from the regional health service and hospital perspectives].

    Science.gov (United States)

    Berti, Elena; Fortuna, Daniela; Bartoli, Simona; Ciuca, Cristina; Orlando, Anna; Scondotto, Salvatore; Agabiti, Nera; Salizzoni, Stefano; Aranzulla, Tiziana Claudia; Gandolfo, Caterina; De Palma, Rossana; Saia, Francesco

    2016-12-01

    The aim of this study was to estimate the cost of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) procedures, together with the cost of the first-year hospitalizations following the index ones, in 4 Italian regions where diffusion level of TAVI and coverage decisions are different. The cost analysis was performed evaluating 372 patients enrolled consecutively from December 1, 2012 to September 30, 2015. The index hospitalization cost was calculated both from the hospital perspective through a full-costing approach and from the regional healthcare service perspective by applying the regional reimbursement tariffs. The follow-up costs were calculated for one year after the index hospitalization, from the regional healthcare sservice perspective, through the identification of hospital admissions for cardiovascular pathologies after the index hospitalization and computation of the relative regional tariffs. The mean hospitalization cost was € 32 120 for transfemoral TAVI (232 procedures), € 35 958 for transapical TAVI (31 procedures) and € 17 441 for AVR (109 procedures). From the regional healthcare service perspective, the mean transfemoral TAVI cost was € 29 989, with relevant regional variability (range from € 19 987 to € 36 979); the mean transapical TAVI cost was € 39 148; the mean AVR cost was € 32 020. The mean follow-up costs were € 2294 for transfemoral TAVI, € 2335 for transapical TAVI, and € 2601 for AVR. In our study, transapical TAVI resulted more expensive than transfemoral TAVI, while surgical AVR was cheaper than both (less than 40%). Costs of the transfemoral approach showed great variability between participating regions, probably due to different hospital costs, logistics, patients' selection and reimbursement policy. A central level of control would be appropriate to avoid unjustified differences in access to innovative procedures between different Italian regions.

  7. Transcatheter Heart Valve Selection and Permanent Pacemaker Implantation in Patients With Pre-Existent Right Bundle Branch Block.

    Science.gov (United States)

    van Gils, Lennart; Tchetche, Didier; Lhermusier, Thibault; Abawi, Masieh; Dumonteil, Nicolas; Rodriguez Olivares, Ramón; Molina-Martin de Nicolas, Javier; Stella, Pieter R; Carrié, Didier; De Jaegere, Peter P; Van Mieghem, Nicolas M

    2017-03-03

    Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by

  8. Effect of experience on results of transcatheter aortic valve implantation using a Medtronic CoreValve System.

    Science.gov (United States)

    Nuis, Rutger-Jan; van Mieghem, Nicolas M; van der Boon, Robert M; van Geuns, Robert-Jan; Schultz, Carl J; Oei, Frans B; Galema, Tjebbe W; Raap, Goris Bol; Koudstaal, Peter J; Geleijnse, Marcel L; Kappetein, Arie Pieter; Serruys, Patrick W; de Jaegere, Peter P

    2011-06-15

    Outcome after transcatheter aortic valve implantation (TAVI) depends on the patient risk profile, operator experience, progress in technology, and technique. We sought to compare the results of TAVI during the initiation phase and after certification to perform TAVI with the Medtronic CoreValve System without proctoring. A total of 165 consecutive patients was categorized into a first cohort of 33 patients treated before certification (November 2005 to December 2007) and a second cohort of 132 patients treated after certification (January 2008 to October 2010). The study end points were selected and defined according to the Valve Academic Research Consortium recommendations. Compared to cohort 2, the patients in cohort 1 more frequently had New York Heart Association class III-IV (100% vs 71%, p <0.001), hypertension (67% vs 39%, p = 0.004), and aortic regurgitation grade III-IV (46% vs 22%, p = 0.006) before TAVI. Over time, the patients in cohort 2 more frequently underwent a truly percutaneous approach (98% vs 82%, p = 0.002) without circulatory support (96% vs 67%, p <0.001) but with more concomitant percutaneous coronary intervention (11% vs 0%, p = 0.042) than the patients in cohort 1. They also more often received a 29-mm prosthesis (72% vs 24%, p <0.001), required less postimplantation balloon dilation (10% vs 27%, p = 0.008), and had less aortic regurgitation grade III-IV after TAVI (12% vs 30%, p = 0.010). The clinical outcome showed a nonsignificant reduction in the combined safety end point (30% to 17%) but a significant reduction in cerebrovascular events (21% to 7%, p = 0.020) and life-threatening bleeding (15% to 5%, p = 0.044) in cohort 2. However, the reduction in overall bleeding and vascular complications (25% and 14%, respectively) was not significant. In conclusion, TAVI became significantly less complex and was associated with better results over time but remained associated with a high frequency of periprocedural major cardiovascular

  9. An adjustable, butterfly-design, titanium-expanded polytetrafluoroethylene implant for nasal valve dysfunction: a pilot study.

    Science.gov (United States)

    Hurbis, Charles G

    2006-01-01

    To investigate the design of a simple, adjustable, biocompatible nasal implant that consistently corrects nasal valvular dysfunction. This study presents data on an adjustable titanium-expanded polytetrafluoroethylene (ePTFE) implant designed as a spanning butterfly graft. Each patient was measured for implant effectiveness subjectively by patient questionnaire and objectively with static and dynamic photographs as well as acoustic rhinomanometry data. Rhinomanometry studies, photographic evidence, and patient questionnaires revealed that a great improvement in the nasal airway can consistently be achieved at the level of the nasal valve using the titanium-ePTFE butterfly design implant. The titanium-ePTFE butterfly-design implant provides a consistent and adjustable correction of the dysfunctional nasal valve.

  10. Nursing leadership of the transcatheter aortic valve implantation Heart Team: Supporting innovation, excellence, and sustainability.

    Science.gov (United States)

    Lauck, Sandra B; McGladrey, Janis; Lawlor, Cindy; Webb, John G

    2016-05-01

    Transcatheter Aortic Valve Implantation (TAVI) is an innovative and resource-intensive treatment of valvular heart disease. Growing evidence and excellent outcomes are contributing to increased patient demand. The Heart Team is foundational to TAVI programs to manage the complexities of case selection and other aspects of care. The competencies and expertise of nurses are well suited to provide administrative and clinical leadership within the TAVI Heart Team to promote efficient, effective, and sustainable program development. The contributions of nursing administrative and clinical leaders exemplify the leadership roles that nurses can assume in healthcare innovation. © 2016 The Canadian College of Health Leaders.

  11. Transcatheter implantation of self-expandable valved prosthesis in outlet right ventricle an experimental study in pigs.

    Science.gov (United States)

    Guilhen, José Cícero Stocco; Palma, José Honório; Gaia, Diego Felipe; Araujo, Andre Telis Vilela de; Teles, Carlos Alberto; Branco, João Nelson; Buffolo, Enio

    2011-01-01

    Patients with congenital heart disease who underwent pulmonary valvotomy or surgery to open the pulmonary valve ring are prone to develop residual pulmonary insufficiency or stenosis that may lead to right heart failure with clinical deterioration. These children require multiple interventions throughout their lives, which impose a high rate of morbidity and mortality. To develop a less invasive technique for implantation of a valved prosthesis through the right ventricle. The valved prosthesis consists of an auto expanding metal stent built with nitinol, surrounded with polyester, where the three leaflets of bovine pericardium were mounted. Twelve pigs were used to perform the implants. Echocardiographic control was performed immediately after implantation and one, four, eight and 12 weeks. One animal showed reflux of moderate to severe and three mild reflux. Transvalvular gradients measured before implantation ranged from 3 to 6 mmHg and that soon after the implant was increased, ranging from 7 to 45 mmHg. There was a decrease in these gradients during follow up and in only four of the twelve animals the gradients were above 20 mmHg. Thrombus formation occurred in the prosthesis of six animals, and this was the most frequent complication. These findings highlight the need for studies with the use of anticoagulants and antiplatelet, an attempt to reduce this event. The study aims to contribute for the start of the use of prosthetic heart valves that could be implanted through minimally invasive techniques without the use of cardiopulmonary bypass.

  12. Successful balloon aortic valvuloplasty as a bridge therapy to transcatheter aortic valve implantation during the proctoring period

    OpenAIRE

    Yanagisawa, Hiromu; Saito, Naritatsu; Imai, Masao; Minakata, Kenji; Fujita, Takanari; Watanabe, Shin; Watanabe, Hirotoshi; Yamazaki, Kazuhiro; Toyota, Toshiaki; Taniguchi, Tomohiko; Tazaki, Junichi; Shizuta, Satoshi; Daijo, Hiroki; Sakata, Ryuzo; Kimura, Takeshi

    2015-01-01

    In Japan, transcatheter aortic valve implantation (TAVI) with Edwards-SAPIEN XT valve (Edwards Lifesciences Inc., Irvine, CA, USA) started in October 2013. All institutions should undergo a training period to perform TAVI independently. Balloon aortic valvuloplasty (BAV) as a bridge to TAVI during the training period should be performed with caution to avoid severe aortic regurgitation (AR) because bailout TAVI is not possible. We present a case in which BAV was successfully performed as a br...

  13. Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.

    Science.gov (United States)

    van Rosendael, Philippe J; Delgado, Victoria; Bax, Jeroen J

    2018-02-06

    The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3-37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7-26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated with increased risk of PPI. The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and

  14. Successful implantation of a second-generation aortic valve in severe aortic regurgitation secondary to a traumatic cusp lesion

    Energy Technology Data Exchange (ETDEWEB)

    Mangieri, Antonio [Cardio-Thoracic-Vascular Department, San Raffaele Institute, Milan (Italy); Latib, Azeem, E-mail: info@emocolumbus.it [Cardio-Thoracic-Vascular Department, San Raffaele Institute, Milan (Italy); EMO-GVM Centro Cuore Columbus, Milan (Italy); Aurelio, Andrea [Cardio-Thoracic-Vascular Department, San Raffaele Institute, Milan (Italy); Figini, Filippo [Cardio-Thoracic-Vascular Department, San Raffaele Institute, Milan (Italy); EMO-GVM Centro Cuore Columbus, Milan (Italy); Agricola, Eustachio; Rosa, Isabella; Stella, Stefano; Spagnolo, Pietro; Castiglioni, Alessandro [Cardio-Thoracic-Vascular Department, San Raffaele Institute, Milan (Italy); Colombo, Antonio [Cardio-Thoracic-Vascular Department, San Raffaele Institute, Milan (Italy); EMO-GVM Centro Cuore Columbus, Milan (Italy)

    2015-10-15

    A 67-year-old man with a dilated cardiomyopathy and severe aortic regurgitation (AR) secondary to a traumatic cusp lesion was referred to our institution because of progressive worsening of dyspnea. After formal discussion in the heart team, the patient was scheduled for TAVI (transcatheter aortic valve implantation). The pre procedural computed tomography scan revealed a minimum amount of calcium on the aortic valve and low position of coronary ostia. The TAVI procedure was performed with the implantation of a fully retrievable and repositionable aortic valve prosthesis (Direct Flow 29 mm, Direct Flow Medical, Santa Rosa, California) with an excellent result and no paravalvular leak. The TAVI devices designed for the treatment of calcific aortic stenosis have numerous limitations for the treatment of pure AR such as the risk of residual AR, the lack of repositionability and retrievability, and the need for valve- in-valve implantation. We believe that treatment of selected cases of pure AR with the Direct Flow valve is feasible and takes advantage of the retrievability of the prosthesis.

  15. Cerebrovascular accidents complicating transcatheter aortic valve implantation: frequency, timing and impact on outcomes.

    Science.gov (United States)

    Stortecky, Stefan; Windecker, Stephan; Pilgrim, Thomas; Heg, Dik; Buellesfeld, Lutz; Khattab, Ahmed A; Huber, Christoph; Gloekler, Steffen; Nietlispach, Fabian; Mattle, Heinrich; Jüni, Peter; Wenaweser, Peter

    2012-05-15

    Cerebrovascular accidents (CVA) are considered among the most serious adverse events after transcatheter aortic valve implantation (TAVI). The objective of the present study was to evaluate the frequency and timing of CVA after TAVI and to investigate the impact on clinical outcomes within 30 days of the procedure. Between August 2007 and October 2011, 389 high-risk elderly patients with symptomatic severe aortic stenosis underwent TAVI via transfemoral, transapical or subclavian access. A total of 14 patients (3.6%) experienced at least one CVA within 30 days of follow-up and most events (74%) occurred within the first day of the procedure. Patients with CVA had an increased risk of all-cause (42.3% vs. 5.1%, ORadjusted 11.7, 95% CI 3.4-40.3, pCerebrovascular accidents among patients undergoing TAVI occur predominantly during the periprocedural period, are associated with multiple implantation attempts of the bioprosthesis and significantly impair prognosis.

  16. Clinical observation on Ahmed glaucoma valve implantation for teenagers with refractory glaucoma

    Directory of Open Access Journals (Sweden)

    Dong-Dao Song

    2016-06-01

    Full Text Available AIM:To observe the clinical effect of Ahmed glaucoma valve(AGVimplantation for teenagers with refractory glaucoma. METHODS: Twenty-seven patients(27 eyeswith refractory glaucoma were treated with AGV implantation in our hospital from October 2012 to October 2014. The patients were followed up for 12mo. The success rate of the operation, postoperative intraocular pressure, the best corrected visual acuity, as well as complications were recorded. RESULTS: The success rate of the operation was 85%. The intraocular pressure of the 27 patients decreased from 48.3±8.3mmHg before operations to 21.4±8.1mmHg(PPCONCLUSION: AGV implantation is characterized by a high success rate, simple operation, less complications and is an effective treatment for refractory glaucoma in adolescents.

  17. Baseline MDCT findings after prosthetic heart valve implantation provide important complementary information to echocardiography for follow-up purposes

    Energy Technology Data Exchange (ETDEWEB)

    Sucha, Dominika; Mali, Willem P.T.M.; Habets, Jesse [University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Chamuleau, Steven A.J. [University Medical Center Utrecht, Department of Cardiology, Utrecht (Netherlands); Symersky, Petr [VU Medical Center, Department of Cardiothoracic Surgery, Amsterdam (Netherlands); Meijs, Matthijs F.L. [Thoraxcentrum Twente, Medisch Spectrum Twente, Department of Cardiology, Enschede (Netherlands); Brink, Renee B.A. van den [Academic Medical Center, Department of Cardiology, Amsterdam (Netherlands); Mol, Bas A.J.M. de [Academic Medical Center, Department of Cardiothoracic Surgery, Amsterdam (Netherlands); Herwerden, Lex A. van [University Medical Center Utrecht, Department of Cardiothoracic Surgery, Utrecht (Netherlands); Budde, Ricardo P.J. [University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Erasmus University Medical Center, Department of Radiology, Rotterdam (Netherlands)

    2016-04-15

    Recent studies have proposed additional multidetector-row CT (MDCT) for prosthetic heart valve (PHV) dysfunction. References to discriminate physiological from pathological conditions early after implantation are lacking. We present baseline MDCT findings of PHVs 6 weeks post implantation. Patients were prospectively enrolled and TTE was performed according to clinical guidelines. 256-MDCT images were systematically assessed for leaflet excursions, image quality, valve-related artefacts, and pathological and additional findings. Forty-six patients were included comprising 33 mechanical and 16 biological PHVs. Overall, MDCT image quality was good and relevant regions remained reliably assessable despite mild-moderate PHV-artefacts. MDCT detected three unexpected valve-related pathology cases: (1) prominent subprosthetic tissue, (2) pseudoaneurysm and (3) extensive pseudoaneurysms and valve dehiscence. The latter patient required valve surgery to be redone. TTE only showed trace periprosthetic regurgitation, and no abnormalities in the other cases. Additional findings were: tilted aortic PHV position (n = 3), pericardial haematoma (n = 3) and pericardial effusion (n = 3). Periaortic induration was present in 33/40 (83 %) aortic valve patients. MDCT allowed evaluation of relevant PHV regions in all valves, revealed baseline postsurgical findings and, despite normal TTE findings, detected three cases of unexpected, clinically relevant pathology. (orig.)

  18. Superior transseptal approach to mitral valve is associated with a higher need for pacemaker implantation than the left atrial approach

    DEFF Research Database (Denmark)

    Lukac, Peter; Hjortdal, Vibeke E; Pedersen, Anders K

    2006-01-01

    BACKGROUND: Several studies suggest that the superior transseptal approach to mitral valve surgery leads to sinus node dysfunction. The clinical consequences are not known. METHODS: Consecutive patients undergoing surgery for mitral valve disease from November 16, 1994 through January 26, 2004 were...... to adjust for possible confounders. RESULTS: We included 577 patients, 150 in group A and 427 in group B. Forty-four patients had a pacemaker implanted after the surgery; 17 in group A and 27 in group B (p = 0.010). The superior transseptal approach was an independent risk factor of pacemaker implantation...

  19. Image-guidance for transcatheter aortic valve implantation (TAVI) and cerebral embolic protection.

    Science.gov (United States)

    Vernikouskaya, I; Rottbauer, W; Gonska, B; Rodewald, C; Seeger, J; Rasche, V; Wöhrle, J

    2017-12-15

    The study was aimed at evaluation of the feasibility and potential benefit of image fusion (IF) of pre-procedural CT angiography (CTA) and x-ray (XR) fluoroscopy for image-guided navigation in transfemoral transcatheter aortic valve implantation (TAVI) with the strong focus on guiding the double-filter cerebral embolic protection device and valve prosthesis placement. In 31 patients undergoing TAVI, image registration of CTA-derived 3D anatomical models of the relevant cardiac anatomy and vasculature, and live XR was performed applying a commercially available navigation tool. The approach was evaluated in terms of the accuracy of the overlay. In 27 TAVI patients with IF receiving double-filter cerebral embolic protection device overall procedure time, fluoroscopy time, radiation dose, and total volume of intra-procedural iodinated contrast agent (CA) were registered and compared to those of a control group of prospectively enrolled during the same period of time N=27 patients receiving the same protection system but without IF. Image co-registration and model-based guidance is feasible in TAVI procedures. The overlay facilitates placement of the embolic protection device, placement of the guide wire in the left ventricle and initial alignment of the valve prosthesis prior to final deployment, thus improving the confidence level of the operators during the procedure without compromising CA or XR dose. Copyright © 2017. Published by Elsevier B.V.

  20. Comparative performance of transcatheter aortic valve-in-valve implantation versus conventional surgical redo aortic valve replacement in patients with degenerated aortic valve bioprostheses: systematic review and meta-analysis.

    Science.gov (United States)

    Gozdek, Miroslaw; Raffa, Giuseppe Maria; Suwalski, Piotr; Kolodziejczak, Michalina; Anisimowicz, Lech; Kubica, Jacek; Navarese, Eliano Pio; Kowalewski, Mariusz

    2017-09-08

    The objective of this report was to directly compare, by means of a systematic review and meta-analysis, redo surgical aortic valve replacement (re-sAVR) with valve-in-valve transcatheter aortic valve implantation (ViV TAVI) for patients with failed degenerated aortic bioprostheses. Multiple databases were screened for all available reports comparing ViV TAVI with re-sAVR in patients with failing degenerated aortic bioprostheses. The primary outcome was all-cause mortality determined from the longest available survival data. Five observational studies (n = 342) were included in the meta-analysis; patients in the ViV TAVI group were older and had a higher baseline risk compared to those in the re-sAVR group. Although there was no statistical difference in procedural mortality [risk ratio (RR) 0.74, 95% confidence interval (CI) 0.18-2.97; P = 0.67], 30-day mortality (RR 1.29, 95% CI 0.44-3.78; P = 0.64) and cardiovascular mortality (RR 0.91, 95% CI 0.30-2.70; P = 0.86) at a mean follow-up period of 18 months, cumulative survival analysis favoured surgery with borderline statistical significance (ViV TAVI versus re-sAVR: hazard ratio 1.91, 95% CI 1.03-3.57; P = 0.039). ViV TAVI was associated with a significantly lower rate of permanent pacemaker implantations (RR 0.37, 95% CI 0.20-0.68; P = 0.002) and shorter intensive care unit (P superior echocardiographic outcomes: lower incidence of patient-prosthesis mismatch (P = 0.008), fewer paravalvular leaks (P = 0.023) and lower mean postoperative aortic valve gradients in the prespecified analysis (P = 0.017). The ViV TAVI approach is a safe and feasible alternative to re-sAVR that may offer an effective, less invasive treatment for patients with failed surgical aortic valve bioprostheses who are inoperable or at high risk. Re-sAVR should remain the standard of care, particularly in the low-risk population, because it offers superior haemodynamic outcomes with low mortality rates.

  1. Ahmed Glaucoma Valve Implantation for Refractory Glaucoma in a Tertiary Hospital in Brazil.

    Science.gov (United States)

    Abe, Ricardo Yuji; Tavares, Carla Melo; Schimiti, Rui Barroso; Vasconcellos, José Paulo Cabral; Costa, Vital Paulino

    2015-01-01

    Purpose. To evaluate the efficacy of Ahmed Glaucoma Valve (AGV) implantation in patients with refractory glaucoma in a tertiary hospital in Brazil. Methods. Retrospective case series of patients who underwent AGV implantation. Primary outcome was to assess the rate of failure, which was defined as intraocular pressure (IOP) in two consecutive visits greater than 18 or lower than 5 mmHg (criterion 1) or IOP greater than 15 or lower than 5 mmHg (criterion 2). The secondary outcome was to investigate risk factors for failure. Results. 112 eyes from 108 patients underwent AGV implantation between 2000 and 2012. Mean follow-up time was 2.54 (±1.52) years. Kaplan-Meier survival analysis showed cumulative probabilities of success of 80.3%, 68.2%, and 47.3% at 1, 3, and 5 years using 18 mmHg as endpoint. When adopting 15 mmHg as endpoint, cumulative success rates were 80.3%, 60.7%, and 27.3% at 1, 3, and 5 years, respectively. Multivariate analysis with generalized estimating equations revealed that African American ancestry and early hypertensive phase were risk factors for failure (P = 0.001 and P = 0.002, resp.). Conclusion. A success rate of approximately 50% was obtained 5 years after the implantation of an AGV. African American ancestry and early hypertensive phase were associated with increased risk of failure.

  2. Our experience of fibrin sealant-assisted implantation of Ahmed glaucoma valve.

    Science.gov (United States)

    Choudhari, Nikhil S; Neog, Aditya; Sharma, Anuj; Iyer, Geetha K; Srinivasan, Bhaskar

    2013-01-01

    To report our experience with the fibrin sealant as a suture substitute for securing the human scleral patch graft during implantation of Ahmed glaucoma valve (AGV). A retrospective, non-comparative study of 12 eyes of 12 patients who underwent an AGV implantation with fibrin sealant for part of the procedure during June 2009 to September 2010. The mean patient age was 21.5 ± 20.6 years. Male: Female ratio was 2 : 1. Seven (58.3%) patients were monocular. The indications for AGV were varied. The mean number of intra-ocular surgeries prior to an implantation of AGV was 1.8. The mean follow-up duration was 24.5 ± 17.9 weeks. There was a statistically significant reduction in the mean IOP and in the mean number of anti-glaucoma medications at the final visit compared to the pre-operative values (P AGV tube exposure, tube-cornea touch, or conjunctival erosion. Vision threatening complication viz. late post-operative rhegmatogenous retinal detachment, unlikely to be related to the use of the fibrin sealant, occurred in 2 (16.6%) eyes. The fibrin sealant offers the advantages of safety and convenience to the placement of a scleral patch graft during an AGV implantation.

  3. Effect of glaucoma tube shunt parameters on cornea endothelial cells in patients with Ahmed valve implants.

    Science.gov (United States)

    Koo, Euna B; Hou, Jing; Han, Ying; Keenan, Jeremy D; Stamper, Robert L; Jeng, Bennie H

    2015-01-01

    The aim of this study was to assess the effect of various tube parameters on corneal endothelial cell density (ECD) after insertion of Ahmed valves. Thirty-nine eyes of 33 patients with previous superotemporal (ST) Ahmed valve implantation and 20 eyes of 13 participants with previous uncomplicated phacoemulsification and intraocular lens implantation but no history of glaucoma surgery were evaluated. Various tube parameters were measured with anterior segment optical coherence tomography. ST, central, and inferonasal (IN) ECD and pachymetry were measured. Endothelial cell loss and corneal thickness in the ST cornea was compared with those in the IN cornea. The mean age of the operated patients was 58 ± 22 years, and the mean time since glaucoma surgery was 2.5 ± 2.6 years. Thirty-two of the 39 study eyes were pseudophakic. The ECD was significantly lower in the ST endothelium than in the IN endothelium in eyes with glaucoma tube surgery (P cornea and distance from the tip of the tube to the cornea were significant risk factors for decreased ST endothelial cell loss when assessed relative to the IN ECD (P = 0.01 and P = 0.02, respectively). In multivariate analysis, only the distance of the tube tip to the cornea remained significantly associated with ST endothelial cell loss. Although this was a retrospective study with inherent limitations, tubes that are closer to the cornea seem to lead to increased loss of adjacent endothelial cells.

  4. Outcomes of Transfemoral Transcatheter Aortic Valve Implantation in Patients With Previous Coronary Bypass.

    Science.gov (United States)

    Leshem-Rubinow, Eran; Abramowitz, Yigal; Steinvil, Arie; Ben-Assa, Eyal; Chorin, Ehud; Shacham, Yacov; Yankelson, Lior; Konigstein, Maayan; Keren, Gad; Banai, Shmuel; Finkelstein, Ariel

    2015-08-01

    Patients with previous coronary artery bypass grafting (CABG) are considered to be at increased perioperative risk for a redo cardiac operation. In the era of transcatheter aortic valve implantation (TAVI), these patients constitute a considerable portion of those with severe aortic stenosis referred for TAVI. We evaluated the impact of previous CABG on transfemoral TAVI outcomes. Patients with severe symptomatic aortic stenosis (n = 515) who underwent transfemoral TAVI were divided according to the presence of history of CABG. Patients with previous valvular surgery were excluded (n = 12). TAVI clinical end points and adverse events were considered according to the Valve Academic Research Consortium 2 definitions. Survival was estimated using Cox regression models at the enter mode with the dependent variable defined as all-cause mortality. Of the total 503 patients who underwent TAVI, 91 (18.1%) had previous CABG. At baseline, patients with previous CABG were younger (80.8 vs 83.1 years, p <0.001), mostly men (85% vs 35%, p <0.001), had more cardiac and vascular co-morbidities, higher mean logistic EuroSCORE (32.8 vs 22; p <0.001), lower ejection fraction (53% vs 56%, p <0.001), and lower AV gradients and larger valve area. At a mean follow-up of 636 days, the overall Valve Academic Research Consortium 2-adjudicated end points did not differ. No differences in mortality were observed at 30 days, 6 months, and 1 year after TAVI (hazard ratio 1.34, p = 0.55, Cox regression). We conclude that patients with previous CABG who underwent TAVI do not have increased risk of periprocedural complications or mortality, although having distinct clinical features compared with the total TAVI population. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Impact of cone-beam computed tomography on implant planning and on prediction of implant size

    Energy Technology Data Exchange (ETDEWEB)

    Pedroso, Ludmila Assuncao de Mello; Silva, Maria Alves Garcia Santos, E-mail: ludmilapedroso@hotmail.com [Universidade Federal de Goias (UFG), Goiania, GO (Brazil). Fac. de Odontologia; Garcia, Robson Rodrigues [Universidade Federal de Goias (UFG), Goiania, GO (Brazil). Fac. de Odontologia. Dept. de Medicina Oral; Leles, Jose Luiz Rodrigues [Universidade Paulista (UNIP), Goiania, GO (Brazil). Fac. de Odontologia. Dept. de Cirurgia; Leles, Claudio Rodrigues [Universidade Federal de Goias (UFG), Goiania, GO (Brazil). Fac. de Odontologia. Dept. de Prevencao e Reabilitacao Oral

    2013-11-15

    The aim was to investigate the impact of cone-beam computed tomography (CBCT) on implant planning and on prediction of final implant size. Consecutive patients referred for implant treatment were submitted to clinical examination, panoramic (PAN) radiography and a CBCT exam. Initial planning of implant length and width was assessed based on clinical and PAN exams, and final planning, on CBCT exam to complement diagnosis. The actual dimensions of the implants placed during surgery were compared with those obtained during initial and final planning, using the McNemmar test (p < 0.05). The final sample comprised 95 implants in 27 patients, distributed over the maxilla and mandible. Agreement in implant length was 50.5% between initial and final planning, and correct prediction of the actual implant length was 40.0% and 69.5%, using PAN and CBCT exams, respectively. Agreement in implant width assessment ranged from 69.5% to 73.7%. A paired comparison of the frequency of changes between initial or final planning and implant placement (McNemmar test) showed greater frequency of changes in initial planning for implant length (p < 0.001), but not for implant width (p = 0.850). The frequency of changes was not influenced by implant location at any stage of implant planning (chi-square test, p > 0.05). It was concluded that CBCT improves the ability of predicting the actual implant length and reduces inaccuracy in surgical dental implant planning. (author)

  6. Impact of percutaneous pulmonary valve implantation procedural steps on leaflets histology and mechanical behaviour: An in vitro study.

    Science.gov (United States)

    Jalal, Zakaria; Galmiche, Louise; Beloin, Christophe; Boudjemline, Younes

    2016-01-01

    Percutaneous pulmonary valve implantation (PPVI) using the bovine jugular vein Melody(®) valve (Medtronic Inc., Minneapolis, MN, USA) is safe and effective. However, post-procedural complications have been reported, the reasons for which are unclear. To assess the impact of PPVI procedural steps on valvular histology and leaflet mechanical behaviour. Three different valved stents (the Melody(®) valve and two homemade stents with bovine and porcine pericardium) were tested in vitro under four conditions: (1) control group; (2) crimping; (3) crimping plus inflation of low-pressure balloon; (4) condition III plus post-dilatation (high-pressure balloon). For each condition, valvular leaflets (and a venous wall sample for Melody(®) stents) were taken for histological analysis and mechanical uniaxial testing of the valve leaflets. Among the Melody(®) valves, the incidence of transverse fractures was significantly higher in traumatized samples compared with the control group (P<0.05), whereas the incidence and depth of transverse fractures were not statistically different between the four conditions for bovine and porcine pericardial leaflets. No significant modification of the mechanical behaviour of in vitro traumatized Melody(®) valvular leaflets was observed. Bovine and porcine pericardia became more elastic and less resilient after balloon expansion and post-dilatation (conditions III and IV), with a significant decrease in elastic modulus and stress at rupture. Valved stent implantation procedural steps induced histological lesions on Melody(®) valve leaflets. Conversely, bovine and porcine pericardial valved stents were not histologically altered by in vitro manipulations, although their mechanical properties were significantly modified. These data could explain some of the long-term complications observed with these substitutes. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  7. Determinants of image quality of rotational angiography for on-line assessment of frame geometry after transcatheter aortic valve implantation.

    Science.gov (United States)

    Rodríguez-Olivares, Ramón; El Faquir, Nahid; Rahhab, Zouhair; Maugenest, Anne-Marie; Van Mieghem, Nicolas M; Schultz, Carl; Lauritsch, Guenter; de Jaegere, Peter P T

    2016-07-01

    To study the determinants of image quality of rotational angiography using dedicated research prototype software for motion compensation without rapid ventricular pacing after the implantation of four commercially available catheter-based valves. Prospective observational study including 179 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) with either the Medtronic CoreValve (MCS), Edward-SAPIEN Valve (ESV), Boston Sadra Lotus (BSL) or Saint-Jude Portico Valve (SJP) in whom rotational angiography (R-angio) with motion compensation 3D image reconstruction was performed. Image quality was evaluated from grade 1 (excellent image quality) to grade 5 (strongly degraded). Distinction was made between good (grades 1, 2) and poor image quality (grades 3-5). Clinical (gender, body mass index, Agatston score, heart rate and rhythm, artifacts), procedural (valve type) and technical variables (isocentricity) were related with the image quality assessment. Image quality was good in 128 (72 %) and poor in 51 (28 %) patients. By univariable analysis only valve type (BSL) and the presence of an artefact negatively affected image quality. By multivariate analysis (in which BMI was forced into the model) BSL valve (Odds 3.5, 95 % CI [1.3-9.6], p = 0.02), presence of an artifact (Odds 2.5, 95 % CI [1.2-5.4], p = 0.02) and BMI (Odds 1.1, 95 % CI [1.0-1.2], p = 0.04) were independent predictors of poor image quality. Rotational angiography with motion compensation 3D image reconstruction using a dedicated research prototype software offers good image quality for the evaluation of frame geometry after TAVI in the majority of patients. Valve type, presence of artifacts and higher BMI negatively affect image quality.

  8. Transcatheter aortic valve implantation in a patient with circulatory collapse, using the lucas® chest compression system

    DEFF Research Database (Denmark)

    Jensen, Peter Blom; Andersen, Claus; Nissen, Henrik

    2013-01-01

    We describe a case of Transcatheter Aortic Valve Implantation (TAVI) using the LUCAS® Chest Compression System in an elderly high risk patient with severe aortic stenosis and heart failure. In this case, the patient developed severe aortic regurgitation following predilatation of the native aortic...

  9. Altered expression of fibrosis genes in capsules of failed Ahmed glaucoma valve implants.

    Directory of Open Access Journals (Sweden)

    Alka Mahale

    Full Text Available Ahmed glaucoma valve (AGV implant is an aqueous shunt device used to control intraocular pressure in glaucoma. Implant failure results from impervious encapsulation of the shunt plate causing increased hydraulic resistance and raised intraocular pressure. We hypothesized that deregulation of fibrosis pathway contributes to capsular resistance. We tested this by studying fibrosis related gene expression in failed AGV implants.Differential gene expression was examined in failed AGV capsules and compared to normal control tenon. Following total RNA extraction, 84 key genes in fibrosis pathway were examined by real-time PCR using RT2 Profiler PCR Array. Relative gene expression was calculated using ΔΔCt method. Gene specific TaqMan assays were used to validate select genes with ≥2 fold differential expression in the array expression profile.We observed differential expression in several genes in the fibrosis pathway. Almost half (39/84 of examined genes showed ≥2 fold differential expression in majority of capsules examined on the array. TaqMan assays for select genes including CCN2 (CTGF, THBS1, SERPINE1, THBS2, COL3A1, MMP3, and IL1A in an increased validation sample set showed significant changes in expression (p value from <0.001 to 0.022 at a high frequency in concurrence with our array results.Pathway-focused analyses identified candidate genes with altered expression providing molecular evidence for deregulation of the fibrosis pathway in AGV failure.

  10. Altered expression of fibrosis genes in capsules of failed Ahmed glaucoma valve implants.

    Science.gov (United States)

    Mahale, Alka; Othman, Maha W; Al Shahwan, Sami; Al Jadaan, Ibrahim; Owaydha, Ohood; Khan, Zahid; Edward, Deepak P

    2015-01-01

    Ahmed glaucoma valve (AGV) implant is an aqueous shunt device used to control intraocular pressure in glaucoma. Implant failure results from impervious encapsulation of the shunt plate causing increased hydraulic resistance and raised intraocular pressure. We hypothesized that deregulation of fibrosis pathway contributes to capsular resistance. We tested this by studying fibrosis related gene expression in failed AGV implants. Differential gene expression was examined in failed AGV capsules and compared to normal control tenon. Following total RNA extraction, 84 key genes in fibrosis pathway were examined by real-time PCR using RT2 Profiler PCR Array. Relative gene expression was calculated using ΔΔCt method. Gene specific TaqMan assays were used to validate select genes with ≥2 fold differential expression in the array expression profile. We observed differential expression in several genes in the fibrosis pathway. Almost half (39/84) of examined genes showed ≥2 fold differential expression in majority of capsules examined on the array. TaqMan assays for select genes including CCN2 (CTGF), THBS1, SERPINE1, THBS2, COL3A1, MMP3, and IL1A in an increased validation sample set showed significant changes in expression (p value from AGV failure.

  11. Outcomes of Ahmed glaucoma valve implantation in advanced primary congenital glaucoma with previous surgical failure

    Science.gov (United States)

    Huang, Jingjing; Lin, Jialiu; Wu, Ziqiang; Xu, Hongzhi; Zuo, Chengguo; Ge, Jian

    2015-01-01

    Purpose The purpose of this study was to evaluate the intermediate surgical results of Ahmed glaucoma valve (AGV) implantation in patients less than 7 years of age, with advanced primary congenital glaucoma who have failed previous surgeries. Patients and methods Consecutive patients with advanced primary congenital glaucoma that failed previous operations and had undergone subsequent AGV implantation were evaluated retrospectively. Surgical success was defined as 1) intraocular pressure (IOP) ≥6 and ≤21 mmHg; 2) IOP reduction of at least 30% relative to preoperative values; and 3) without the need for additional surgical intervention for IOP control, loss of light perception, or serious complications. Results Fourteen eyes of eleven patients were studied. Preoperatively, the average axial length was 27.71±1.52 (25.56–30.80) mm, corneal diameter was 14.71±1.07 (13.0–16.0) mm, cup-to-disc ratio was 0.95±0.04 (0.9–1.0), and IOP was 39.5±5.7 (30–55) mmHg. The mean follow-up time was 18.29±10.96 (5–44, median 18) months. There were significant reductions in IOPs and the number of glaucoma medications (PAGV implantation remains a viable option for patients with advanced primary congenital glaucoma unresponsive to previous surgical intervention, despite a relatively high incidence of severe surgical complications. PMID:26082610

  12. Outcomes of Ahmed glaucoma valve implantation in advanced primary congenital glaucoma with previous surgical failure

    Directory of Open Access Journals (Sweden)

    Huang J

    2015-06-01

    Full Text Available Jingjing Huang,1 Jialiu Lin,1 Ziqiang Wu,2 Hongzhi Xu,3 Chengguo Zuo,1 Jian Ge1 1State Key Laboratory of Ophthalmology, Department of Glaucoma, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, People’s Republic of China; 2Center for Advanced Eye Care, Carson City, NV, USA; 3Institute of Child Health Policy, University of Florida, Gainesville, FL, USA Purpose: The purpose of this study was to evaluate the intermediate surgical results of Ahmed glaucoma valve (AGV implantation in patients less than 7 years of age, with advanced primary congenital glaucoma who have failed previous surgeries.Patients and methods: Consecutive patients with advanced primary congenital glaucoma that failed previous operations and had undergone subsequent AGV implantation were evaluated retrospectively. Surgical success was defined as 1 intraocular pressure (IOP ≥6 and ≤21 mmHg; 2 IOP reduction of at least 30% relative to preoperative values; and 3 without the need for additional surgical intervention for IOP control, loss of light perception, or serious complications.Results: Fourteen eyes of eleven patients were studied. Preoperatively, the average axial length was 27.71±1.52 (25.56–30.80 mm, corneal diameter was 14.71±1.07 (13.0–16.0 mm, cup-to-disc ratio was 0.95±0.04 (0.9–1.0, and IOP was 39.5±5.7 (30–55 mmHg. The mean follow-up time was 18.29±10.96 (5–44, median 18 months. There were significant reductions in IOPs and the number of glaucoma medications (P<0.001 postoperatively. The IOPs after operation were 11.3±3.4, 13.6±5.1, 16.3±2.7, and 16.1±2.6 mmHg at 1 month, 6 months, 12 months, and 18 months, respectively. Kaplan–Meier estimates of the cumulative probability of valve success were 85.7%, 71.4%, and 71.4% at 6, 12, and 18 months, respectively. Severe surgical complications, including erosion of tube, endophthalmitis, retinal detachment, choroidal detachment, and delayed suprachoroidal hemorrhage, occurred in 28

  13. First percutaneous implantation of a completely tissue-engineered self-expanding pulmonary heart valve prosthesis using a newly developed delivery system: a feasibility study in sheep.

    Science.gov (United States)

    Spriestersbach, Hendrik; Prudlo, Antonia; Bartosch, Marco; Sanders, Bart; Radtke, Torben; Baaijens, Frank P T; Hoerstrup, Simon P; Berger, Felix; Schmitt, Boris

    2017-01-01

    In a European consortium, a decellularized tissue-engineered heart valve (dTEHV) based on vessel-derived cells, a fast-degrading scaffold and a self-expanding stent has been developed. The aim of this study was to demonstrate that percutaneous delivery is feasible. To implant this valve prosthesis transcutaneously into pulmonary position, a catheter delivery system was designed and custom made. Three sheep underwent transjugular prototype implantation. Intracardiac echocardiography (ICE), angiography and computed tomography (CT) were applied to assess the position, morphology, function and dimensions of the stented dTEHV. One animal was killed 3 h after implantation and two animals were followed up for 12 weeks. Explanted valves were analyzed macroscopically and microscopically. In all animals, the percutaneous implantation of the stented dTEHV was successful. The prototype delivery system worked at first attempt in all animals. In the first implantation a 22 F system was used: the valve was slightly damaged during crimping. Loading was difficult due to valve-catheter mismatch in volume. In the second and third implantation a 26 F system was used: the valves fitted adequately and stayed intact. Following implantation, these two valves showed moderate regurgitation due to insufficient coaptation. During follow-up, regurgitation increased due to shortened leaflets. At explantation, macroscopic and microscopic analysis confirmed the second and third valve to be intact. Histology revealed autologous recellularization of the decellularized valve after 12 weeks in vivo. It was demonstrated that completely in vitro tissue-engineered heart valves are thin and stable enough to be crimped and implanted transvenously into pulmonary position.

  14. Rationale and design of the edwards SAPIEN-3 periprosthetic leakage evaluation versus medtronic corevalve in transfemoral aortic valve implantation (ELECT) trial : A randomised comparison of balloon-expandable versus self-expanding transcatheter aortic valve prostheses

    NARCIS (Netherlands)

    Abawi, M; Agostoni, Pierfrancesco; Kooistra, N H M; Samim, M; Nijhoff, F; Voskuil, M; Nathoe, H; Doevendans, P A; Chamuleau, S A; Urgel, K; Hendrikse, J; Leiner, T; Abrahams, A C; van der Worp, B; Stella, P R

    2017-01-01

    Background and objectives Periprosthetic aortic regurgitation (PPR) after transcatheter aortic valve implantation (TAVI) remains an important issue associated with impaired long-term outcomes. The current randomised study aims to evaluate potential differences between the balloon-expandable Edwards

  15. Transfemoral aortic valve implantation for severe aortic stenosis in a patient with dextrocardia situs inversus.

    Science.gov (United States)

    Good, Richard I S; Morgan, Kenneth P; Brydie, Alan; Beydoun, Hussein K; Nadeem, S Najaf

    2014-09-01

    Transcatheter aortic valve implantation (TAVR) has grown rapidly over the past 10 years. Device and delivery catheter systems have evolved to facilitate the procedure and reduce the risk of associated complications, including those related to vascular access. It is important to understand the utility of the TAVR equipment in patients with more challenging anatomy to select the most appropriate technique for this complex procedure. We report the first case, to our knowledge, of a patient with dextrocardia situs inversus and previous coronary artery bypass grafting who underwent TAVR from the femoral route using the Edwards SAPIEN XT Novaflex+ Transfemoral System (Edwards Lifesciences, Irvine, CA). Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  16. Hypertensive phase and early complications after Ahmed glaucoma valve implantation with intraoperative subtenon triamcinolone acetonide

    Directory of Open Access Journals (Sweden)

    Turalba AV

    2014-07-01

    Full Text Available Angela V Turalba,1,2 Louis R Pasquale1,2 1Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA, USA; 2Department of Ophthalmology, Harvard Medical School, Boston, MA, USA Objective: To evaluate intraoperative subtenon triamcinolone acetonide (TA as an adjunct to Ahmed glaucoma valve (AGV implantation. Design: Retrospective comparative case series. Participants: Forty-two consecutive cases of uncontrolled glaucoma undergoing AGV implantation: 19 eyes receiving intraoperative subtenon TA and 23 eyes that did not receive TA.Methods: A retrospective chart review was performed on consecutive pseudophakic adult patients with uncontrolled glaucoma undergoing AGV with and without intraoperative subtenon TA injection by a single surgeon. Clinical data were collected from 42 eyes and analyzed for the first 6 months after surgery.Main outcome measures: Primary outcomes included intraocular pressure (IOP and number of glaucoma medications prior to and after AGV implantation. The hypertensive phase (HP was defined as an IOP measurement of greater than 21 mmHg (with or without medications during the 6-month postoperative period that was not a result of tube obstruction, retraction, or malfunction. Postoperative complications and visual acuity were analyzed as secondary outcome measures. Results: Five out of 19 (26% TA cases and 12 out of 23 (52% non-TA cases developed the HP (P=0.027. Mean IOP (14.2±4.6 in TA cases versus [vs] 14.7±5.0 mmHg in non-TA cases; P=0.78, and number of glaucoma medications needed (1.8±1.3 in TA cases vs 1.6±1.1 in the comparison group; P=0.65 were similar between both groups at 6 months. Although rates of serious complications did not differ between the groups (13% in the TA group vs 16% in the non-TA group, early tube erosion (n=1 and bacterial endophthalmitis (n=1 were noted with TA but not in the non-TA group.Conclusions: Subtenon TA injection during AGV implantation may decrease the

  17. Surgical Management of Percutaneous Transfemoral Access to Minimize Vascular Complications Related to Transcatheter Aortic Valve' Implantation.

    Science.gov (United States)

    Lareyre, Fabien; Raffort, Juliette; Dommerc, Carine; Habib, Yacoub; Bourlon, François; Mialhe, Claude

    2018-02-01

    Transcatheter aortic valve implantation (TAVI) is associated with substantial rates of vascular complications. The aim of our study is to describe the surgical management of percutaneous transfemoral access by a vascular surgeon and to report the 30-day postoperative vascular complications and mortality. Perioperative procedures to manage the femoral access site were recorded retrospectively from 220 consecutive patients who underwent TAVI. Postoperative vascular complications related to the main access were categorized according to the Valve Academic Research Consortium 2 classification. Perioperative procedures related to vascular access were performed for 56 (25.4%) patients: 6 patients required open surgical repair, 48 patients underwent endovascular stenting, and 2 patients had both procedures. The all-cause mortality was 3.6%, but no death related to a vascular complication was reported during the 30-day postoperative follow-up period. Ten (4.5%) patients developed postoperative hematomas; 2 (0.9%) of them were retroperitoneal and led to major bleeding requiring an unplanned surgical intervention. Our study underlines the utility of a multidisciplinary approach to manage the percutaneous access in TAVI for managing postoperative vascular complications.

  18. Hypertensive phase and early complications after Ahmed glaucoma valve implantation with intraoperative subtenon triamcinolone acetonide.

    Science.gov (United States)

    Turalba, Angela V; Pasquale, Louis R

    2014-01-01

    To evaluate intraoperative subtenon triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation. Retrospective comparative case series. Forty-two consecutive cases of uncontrolled glaucoma undergoing AGV implantation: 19 eyes receiving intraoperative subtenon TA and 23 eyes that did not receive TA. A retrospective chart review was performed on consecutive pseudophakic adult patients with uncontrolled glaucoma undergoing AGV with and without intraoperative subtenon TA injection by a single surgeon. Clinical data were collected from 42 eyes and analyzed for the first 6 months after surgery. Primary outcomes included intraocular pressure (IOP) and number of glaucoma medications prior to and after AGV implantation. The hypertensive phase (HP) was defined as an IOP measurement of greater than 21 mmHg (with or without medications) during the 6-month postoperative period that was not a result of tube obstruction, retraction, or malfunction. Postoperative complications and visual acuity were analyzed as secondary outcome measures. Five out of 19 (26%) TA cases and 12 out of 23 (52%) non-TA cases developed the HP (P=0.027). Mean IOP (14.2±4.6 in TA cases versus [vs] 14.7±5.0 mmHg in non-TA cases; P=0.78), and number of glaucoma medications needed (1.8±1.3 in TA cases vs 1.6±1.1 in the comparison group; P=0.65) were similar between both groups at 6 months. Although rates of serious complications did not differ between the groups (13% in the TA group vs 16% in the non-TA group), early tube erosion (n=1) and bacterial endophthalmitis (n=1) were noted with TA but not in the non-TA group. Subtenon TA injection during AGV implantation may decrease the occurrence of the HP but does not alter the ultimate IOP outcome and may pose increased risk of serious complications within the first 6 months of surgery.

  19. Ahmed Glaucoma Valve Implantation for Uveitic Glaucoma Secondary to Behçet Disease.

    Science.gov (United States)

    Satana, Banu; Yalvac, Ilgaz S; Sungur, Gulten; Eksioglu, Umit; Basarir, Berna; Altan, Cigdem; Duman, Sunay

    2015-01-01

    To evaluate outcomes of patients with uveitic glaucoma secondary to Behçet disease (BD) who underwent Ahmed glaucoma valve (AGV) implantation. A retrospective chart review of 14 eyes of 10 patients with uveitic glaucoma associated with BD who underwent AGV implantation at a tertiary referral center. Treatment success was defined as intraocular pressure (IOP) between 6 and 21 mm Hg with or without antiglaucoma medication, without further additional glaucoma surgery or loss of light perception. The main outcome measures were IOP, best-corrected visual acuity measured with Snellen charts, and number of glaucoma medications. Mean duration of postoperative follow-up was 18.2±6.6 months (range, 6 to 31 mo). Of the 14 eyes, 10 (71.4%) were pseudophakic and 5 (35.7%) had primary AGV implantation without a history of previous glaucoma surgery. At the most recent follow-up visit, 13 of the 14 eyes had an IOP between 6 and 21 mm Hg. Mean IOP was significantly reduced during follow-up, as compared with preoperative values (P≤0.005). The cumulative probability of surgical success rate was 90.9% at 18 months based on Kaplan-Meier survival analysis. The mean number of antiglaucoma medications required to achieve the desired IOP decreased from 3.4±0.5 preoperatively to 1.0±1.1 postoperatively (P≤0.05). Visual acuity loss of >2 lines occurred in 4 eyes (28.5%) due to optic atrophy associated with retinal vasculitis. Temporary hypotony developed during follow-up in 4 eyes (28.5%) at first postoperative week. For the management of uveitic glaucoma associated with BD, AGV implantation is a successful method for glaucoma control but requires additional surgical interventions for high early hypotony rates.

  20. Long-term clinical outcomes of Ahmed valve implantation in patients with refractory glaucoma.

    Directory of Open Access Journals (Sweden)

    Chang Kyu Lee

    Full Text Available To evaluate the long-term efficacy of intraocular pressure (IOP reduction and complications of Ahmed Glaucoma Valve (AGV implantation in patients with refractory glaucoma.Retrospective study.The study involved 302 refractory glaucoma patients who underwent AGV implantation and had a minimum follow-up of 6 months between March 1995 and December 2013.An operation was defined as successful when (1 the postoperative IOP remained between 5 and 21 mmHg and was reduced 30% compared to the baseline IOP with or without medication, (2 there was no loss of light perception or vision-threatening severe complications, and (3 no additional filtering or aqueous drainage surgery was required. Clinical records were reviewed.IOP, anti-glaucoma medications, and complications.The mean follow-up period was 62.25 months (range, 6 to 190 months. The cumulative probability of success was 89% at 6 months, 81% at 1 year, 66% at 3 years, 44% at 10 years, and 26% at 15 years. IOP was reduced from a mean of 32.2 ± 10.5 mmHg to 18.6 ± 9.1 mmHg at 1 month, 15.2 ± 7.0 mmHg at 6 months, and 14.2 ± 3.5 mmHg at 15 years. Surgical failures were significantly increased when preoperative IOP was high, and when severe complications occurred after AGV implantation (P < 0.05.AGV implantation was successful for IOP control in patients with refractive glaucoma in the long term. However, the success rate of surgery decreased over time. Preoperative high IOP and severe complications related to the operation were significant risk factors for failure.

  1. Surgical site infections following transcatheter apical aortic valve implantation: incidence and management

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    Baillot Richard

    2012-11-01

    Full Text Available Abstract Objective The present study was undertaken to examine the incidence and management of surgical site infection (SSI in patients submitted to transapical transcatheter aortic valve implantation (TA-TAVI. Methods From April 2007 to December 2011, 154 patients underwent TA-TAVI with an Edwards Sapien bioprosthesis (ES at the Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ as part of a multidisciplinary program to prospectively evaluate percutaneous aortic valve implantation. Patient demographics, perioperative variables, and postoperative complications were recorded in a prospective registry. Results Five (3.2% patients in the cohort presented with an SSI during the study period. The infections were all hospital-acquired (HAI and were considered as organ/space SSI’s based on Center for Disease Control criteria (CDC. Within the first few weeks of the initial procedure, these patients presented with an abscess or chronic draining sinus in the left thoracotomy incision and were re-operated. The infection spread to the apex of the left ventricle in all cases where pledgeted mattress sutures could be seen during debridement. Patients received multiple antibiotic regimens without success until the wound was surgically debrided and covered with viable tissue. The greater omentum was used in three patients and the pectoralis major muscle in the other two. None of the patients died or had a recurrent infection. Three of the patients were infected with Staphylococcus epidermidis, one with Staphylococcus aureus, and one with Enterobacter cloacae. Patients with surgical site infections were significantly more obese with higher BMI (31.4±3.1 vs 26.2±4.4 p=0.0099 than the other patients in the cohort. Conclusions While TA-TAVI is a minimally invasive technique, SSIs, which are associated with obesity, remain a concern. Debridement and rib resection followed by wound coverage with the greater omentum and/or the pectoralis major

  2. Assessment of cardiovascular function following transcatheter aortic valve implantation based on six-minute walk test.

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    Chodór, Piotr; Wilczek, Krzysztof; Zielińska, Teresa; Przybylski, Roman; Głowacki, Jan; Włoch, Łukasz; Zembala, Marian; Kalarus, Zbigniew

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) is presently a recognized treatment mo-dality for patients with severe aortic stenosis ineligible for surgery. It reduces mortality as compared to the conservative treatment. It is further expected from this therapy to improve quality of life by improving of the cardiovascular function performance. The aim of this study is to compare patients' cardiovascular system efficiency in the 6-minute walk test (6MWT) made before and after TAVI and at the 6-12-month follow-up. From January 2009 until February 2012, in the Silesian Center for Heart Diseases in Zabrze, TAVI was performed in 104 patients. Eighty-two patients who underwent 6MWT before surgery were qualified for the analysis. The average age of the patients was 76.0 ± 9.17 years, women made 45.1%. The risk of surgical treatment according to the Logistic Euroscore averaged 22.76 ± 12.63%, and by the Society of Thoracic Surgeons - 5.55 ± 3.34%. The 6MWT was performed within 1 month before the TAVI procedure, up to a month after the procedure and during the 6-12-month follow-up. The 6-minute walk test after TAVI was performed by 64 patients, and after 6-12 month follow-up by 46 patients. The average distance in 6MWT increased from 268.4 ± 89.0 m before treat-ment to 290.0 ± 98.2 m after the procedure (p = 0.008) and 276.1 ± 93.5 m to 343.1 ± 96.7 m after 6-12 months (p < 0.0001). Transcatheter aortic valve implantation procedures significantly improve function of the cardiovascular system evaluated by the 6MWT in 1- and 6-12-month observations. (Cardiol J 2017; 24, 2: 167-175).

  3. Primary Mitral Valve Regurgitation Outcome in Patients With Severe Aortic Stenosis 1 Year After Transcatheter Aortic Valve Implantation: Echocardiographic Evaluation.

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    Florentino, Thiago Marinho; Bihan, David Le; Abizaid, Alexandre Antonio Cunha; Cedro, Alexandre Vianna; Corrêa, Amably Pessoa; Santos, Alexandre Roginski Mendes Dos; Souza, Alexandre Costa; Bignoto, Tiago Costa; Sousa, José Eduardo Moraes Rego; Sousa, Amanda Guerra de Moraes Rego

    2017-07-10

    Mitral valve regurgitation (MR), present in up to 74% of the patients with severe aortic stenosis (AS), can be a negative prognostic factor when moderate or severe. The outcome of MR after percutaneous transcatheter aortic valve implantation (TAVI) and predictors associated with that outcome have not been well established in the literature. To assess the outcome of primary MR in patients submitted to TAVI and to identify associated factors. Observational study of patients with symptomatic severe AS submitted to TAVI from January 2009 to April 2015 at two specialized centers. Echocardiographic outcome was assessed with data collected before and 1 year after TAVI. Of the 91 patients with MR submitted to TAVI and followed up for at least 12 months, 67 (73.6%) had minimum/mild MR before the procedure and 24 (26.4%) had moderate/severe MR. Of those with minimum/mild MR, 62 (92.5%) had no change in the MR grade (p literatura. Avaliar a evolução da IM primária em pacientes submetidos ao TAVI e identificar fatores associados a essa evolução. Realizou-se um estudo observacional em pacientes com EA grave sintomática, submetidos ao TAVI no período de janeiro de 2009 a abril de 2015 em dois centros especializados. Foram avaliados desfechos ecocardiográficos com dados antes e 1 ano após a intervenção. Dos 91 pacientes com IM que realizaram TAVI e tinham acompanhamento de pelo menos 12 meses, 67 (73,6%) apresentavam IM mínima ou discreta antes da realização do procedimento e 24 (26,4%), IM moderada ou grave. Entre os com IM mínima ou discreta, 62 (92,5%) não apresentaram mudança no grau de refluxo (p < 0,001) e 5 (7,5%) tiveram piora. Entre os com IM moderada ou grave, 8 (33,3%) permaneceram na mesma classe e 16 (66,7%) tiveram melhora (p = 0,076). Pacientes com IM moderada ou grave que melhoraram o grau de insuficiência apresentavam menores valores de EuroSCORE II (p = 0,023) e STS morbidade (p = 0,027), quando comparados aos que continuaram na mesma classe

  4. An in vivo model of in situ implantation using pulmonary valved conduit in large animals under off-pump condition.

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    Wu, Hao; Xu, Zhi-wei; Liu, Xian-min; Gong, Da; Wan, Ju-yi; Xu, Xiu-fang; Zhou, Zi-fan; Li, Wen-bin

    2013-12-01

    The application of pulmonary valved conduit to reconstruct the continuity between right ventricles and pulmonary artery is one of the major surgeries. This study aimed to establish an in vivo model of in situ implantation using pulmonary valved conduit in large animals under off-pump condition to validate the long-term effects of artificial pulmonary valved conduit. Domesticate juvenile male sheep and tissue-engineered porcine pulmonary valved conduit were used for the experiment: 30 sheep, weighing (15 ± 3) kg (range 13 to 17 kg) were randomly divided into two groups which were all operated under general anesthesia by off-pump surgery (group 1) and left thoracotomy (group 2). Two different off-pump surgical methods were used to perform cannulation in sheep pulmonary artery to replace part of sheep pulmonary artery with pulmonary valved conduit which will work together with sheep pulmonary artery and valves. During the experiments, animal survival, complication rates, operating time and blood loss were recorded to compare the results between groups and to establish a surgical method with minimal invasion, simplicity, safety, and high success rates. In group 1, a total of 15 cases of surgeries were performed, in which two sheep died; the operative mortality was 13.3% (2/15). In group 2, a total of 15 cases of surgeries were performed, and the surgical mortality rate was 0 (0/15). The operation time and blood loss in group 2 was significantly better than that in group 1. The postoperative echocardiograms showed that, after the surgeries by these two methods, the blood flows were normal, and the valves can open and close freely. Autopsy after 6 months showed that the inner wall and the valves of pulmonary valved conduit were smooth with no thrombus formation. These two off-pump methods are feasible and safe with fewer traumas; but the second method is better and particularly suitable for the establishment of a juvenile animal model.

  5. Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching.

    Science.gov (United States)

    Meco, Massimo; Miceli, Antonio; Montisci, Andrea; Donatelli, Francesco; Cirri, Silvia; Ferrarini, Matteo; Lio, Antonio; Glauber, Mattia

    2017-09-11

    The aim of this meta-analysis was to compare outcomes of patients undergoing transcatheter aortic valve implantation (TAVI) with those undergoing surgical aortic valve replacement using sutureless valves. A systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was performed. No randomized controlled trials were identified. Six comparative studies using propensity score matching met the inclusion criteria. This meta-analysis identified 1462 patients in that 731 patients underwent surgical aortic valve replacement using sutureless valves (SU) and 731 patients underwent a TAVI. The 30-day or in-hospital mortality was lower in the SU group [odds ratio (OR) 0.54, 95% confidence interval (CI) 0.36-0.80; P  = 0.003]. In the TAVI group, the incidence of postoperative stroke was higher (OR 0.36, 95% CI 0.17-0.79; P  = 0.01). The incidence of moderate or severe paravalvular regurgitation was higher in the TAVI group (OR 0.22, 95% CI 0.14-0.35; P  = 0.001). There were neither differences in the postoperative renal failure (OR 1.44, 95% CI 0.46-4.58; P  = 0.53) nor in the number of patients requiring postoperative pacemaker implantation (OR 1.06, 95% CI 0.54-2.08; P  = 0.86). Patients in the SU group required more transfusions (OR 4.47, 95% CI 2.77-7.21; P  = 0.0001), whereas those in the TAVI group had higher major vascular complications (OR 0.06, 95% CI 0.01-0.25; P  = 0.0001). Intensive care unit stay was not different (mean difference 0.99, 95% CI - 1.22 to 1.40; P  = 0.53). One-year survival was better in the SU group (Peto OR 0.35, 95% CI 0.18-0.67; P  = 0.001), as was the 2-year survival (Peto OR 0.38, 95% CI 0.17-0.86; P  = 0.001). Surgical aortic valve replacement using sutureless valves is associated with better early and mid-term outcomes compared with TAVI in high- or intermediate-risk patients.

  6. Evaluation of two different operations to implant the Ahmed glaucoma valve in patients with refractory glaucoma

    Directory of Open Access Journals (Sweden)

    Yue Wu

    2016-04-01

    Full Text Available AIM:To evaluate the efficacy and safety of Ahmed glaucoma valve(AGVimplantation surgery using different methods. METHODS:This was a retrospective study of patients with refractory glaucoma in whom AGV implantation was performed between June 2011 and September 2014. According to the method of tube insertion into the anterior chamber, the sample was divided into two groups, needle-generated scleral tunnel and scleral flap. The surgical success rate, intraocular pressure(IOP, number of antiglaucoma medications used, best correct visual acuity, postoperative complications, and operation duration were analyzed between the two groups. RESULTS:Compared with preoperative data, the two groups showed statistically significant decrease on IOP and the number of antiglaucoma medication used at all follow-up points(PP=0.932; however, statistically significant differences were detected when flat anterior chamber complications between the needle-generated scleral tunnel group(6%and the scleral flap group(24%were compared(P=0.032. CONCLUSION:AGV implantation may be an effective method in managing refractory glaucoma, since the two methods have similar efficacy. However, the needle-generated scleral tunnel technique application could greatly decrease the incidence of flat anterior chamber complications and decrease the duration of the operation.

  7. Clinical observation of Ahmed glaucoma valve implantation for refractory glaucoma by directly puncturing the sclerotic tunnel

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    Zhi-Ke Xu

    2015-02-01

    Full Text Available AIM: To observe the clinic effects and complication of Ahmed glaucoma valve(AGVimplantation in refractory glaucoma by using the 23G syringe needle direct puncture the sclerotic tunnel.METHODS: Forty-four cases(44 eyesof refractory glaucoma underwent AGV implantation by useing the 23G syringe needle direct puncture the sclerotic tunnel. The intraocular pressure(IOP, visual acuity, and complication of post-operation were contrasted with those of pre-operation. RESULTS:The success rate was 84.1%, the mean preoperative IOP in research group was 52.1±10.1mmHg, and the last follow up mean IOP was 15.6±6.9mmHg. Compared with the preoperative visual acuity, 11 eyes increased, 27 eyes had no changes and 6 eyes decreased. The main post-operative complications included shallow anterior chamber(4 eyes, choroidal detachment(3 eyes, drainage tube shift(1 eye, hyphema(6 eyes, drainage tube blockage(1 eye, expulsive choroidal hemorrhage(1 eye, and fiber wrap of drainage tray(5 eyes.CONCLUSION: AGV implantation by direct puncture the sclerotic tunnel is feasible and easy. It avoids of making sclerotic petal and the xenogenic sclera transplanting, simplified the operation technique, prevent the leakage of around tube. The shallow anterior chamber rate is lower. It is an effective procedure for refractory glaucoma.

  8. Effect of early treatment with aqueous suppressants on Ahmed glaucoma valve implantation outcomes.

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    Pakravan, Mohammad; Rad, Shahram Salehi; Yazdani, Shahin; Ghahari, Elaham; Yaseri, Mehdi

    2014-09-01

    To evaluate the effect of early aqueous suppressant treatment on Ahmed glaucoma valve (AGV) surgery outcomes. Randomized clinical trial. Ninety-four eyes of 94 patients with refractory glaucoma. After AGV implantation, 47 cases (group 1) received topical timolol-dorzolamide fixed-combination drops twice daily when intraocular pressure (IOP) exceeded 10 mmHg, whereas 47 controls (group 2) received conventional stepwise treatment when IOP exceeded target pressure. Main outcome measures included IOP and success rate (6 mmHg < IOP < 15 mmHg and IOP reduction of at least 30% from baseline). Other outcome measures included best-corrected visual acuity, complications, and hypertensive phase frequency. Groups 1 and 2 were both followed up for a mean of 45±11.6 and 47.2±7.4 weeks, respectively (P = 0.74). Mixed model analysis revealed a significantly greater IOP reduction in group 1 at all intervals (P<0.001). At 1 year, the cases exhibited a significantly higher success rate (63.2% vs. 33.3%; P = 0.008) and reduced hypertensive phase frequency (23.4% vs. 66.0%; P<0.001). Early aqueous suppressant treatment may improve AGV implantation outcomes in terms of IOP reduction, success rate, and hypertensive phase frequency. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  9. Paravalvular leak after transcatheter aortic valve implantation (TAVI): Short-term results. Data from Polish national POL-TAVI registry.

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    Kleczyński, Paweł; Zasada, Wojciech; Bagieński, Maciej; Rzeszutko, Łukasz; Sorysz, Danuta; Sobczyński, Robert; Trębacz, Jarosław; Kapelak, Bogdan; Zembala, Marian; Dudek, Dariusz

    2016-01-01

    The authors analyzed data from Polish national POL-TAVI registry in terms of paravalvular leak (PVL) occurrence after transcatheter aortic valve implantation (TAVI) and its impact on clinical outcomes. A total of 331 patients with severe aortic stenosis underwent TAVI (Edwards Sapien, n = 141; CoreValve, n = 190). The grade of PVL and survival rate were assessed at6-month follow-up. One hundred and eighty-one (54.7%) patients developed mild PVL, and 22 (6.6%) - moderate PVL after TAVI. No severe PVLs were observed. Occurrence of moderate PVL was device dependent and more frequent in the CoreValve group (p = 0.02). Larger CoreValve device used correlated with the grade of PVL (Spearman: r = 0.19; p = 0.01), but for Edwards Sapien devices this correlation was inverted (Spearman: r = -0.62; p = 0.01). Six-month mortality rate was not significant between patients with no or mild PVL compared to those with moderate PVL (p = 0.12). The PVL occurrence remains a frequent problem after TAVI and is device de-pendent, more common with Edwards 23 mm valve and 31 mm CoreValve prosthesis.

  10. Changes in Corneal Endothelial Cell after Ahmed Glaucoma Valve Implantation and Trabeculectomy: 1-Year Follow-up.

    Science.gov (United States)

    Kim, Min Su; Kim, Kyoung Nam; Kim, Chang-Sik

    2016-12-01

    To compare changes in corneal endothelial cell density (CECD) after Ahmed glaucoma valve (AGV) implantation and trabeculectomy. Changes in corneal endothelium in patients that underwent AGV implantation or trabeculectomy were prospectively evaluated. Corneal specular microscopy was performed at the central cornea using a non-contact specular microscope before surgery and 6 months and 12 months after surgery. The CECD, hexagonality of the endothelial cells, and the coefficient of variation of the cell areas were compared between the two groups. Forty eyes of 40 patients with AGV implantation and 28 eyes of 28 patients with trabeculectomy were studied. Intraocular pressure in the AGV implantation group was significantly higher than that in the trabeculectomy group (p AGV implantation group, the mean CECD significantly decreased by 9.4% at 6 months and 12.3% at 12 months compared with baseline values (both, p AGV implantation group were significantly higher than those in the trabeculectomy group (p = 0.030 and p = 0.027, respectively). In the AGV implantation group, there was a significant decrease in the CECD between baseline and 6 months and between 6 months and 12 months (p AGV implantation group and the trabeculectomy group showed statistically significant decreases in the CECD 1 year after surgery. The decrease in CECD in the AVG implantation group was greater and persisted longer than that in the trabeculectomy group.

  11. Adjunctive Mitomycin C or Amniotic Membrane Transplantation for Ahmed Glaucoma Valve Implantation: A Randomized Clinical Trial.

    Science.gov (United States)

    Yazdani, Shahin; Mahboobipour, Hassan; Pakravan, Mohammad; Doozandeh, Azadeh; Ghahari, Elham

    2016-05-01

    To determine whether adjunctive mitomycin C (MMC) or amniotic membrane transplantation (AMT) improve the outcomes of Ahmed glaucoma valve (AGV) implantation. This double-blind, stratified, 3-armed randomized clinical trial includes 75 eyes of 75 patients aged 7 to 75 years with refractory glaucoma. Eligible subjects underwent stratified block randomization; eyes were first stratified to surgery in the superior or inferior quadrants based on feasibility; in each subgroup, eyes were randomly assigned to the study arms using random blocks: conventional AGV implantation (group A, 25 eyes), AGV with MMC (group B, 25 eyes), and AGV with AMT (group C, 25 eyes). The 3 study groups were comparable regarding baseline characteristics and mean follow-up (P=0.288). A total of 68 patients including 23 eyes in group A, 25 eyes in group B, and 20 eyes group C completed the follow-up period and were analyzed. Intraocular pressure was lower in the MMC group only 3 weeks postoperatively (P=0.04) but comparable at other time intervals. Overall success rate was comparable in the 3 groups at 12 months (P=0.217). The number of eyes requiring medications (P=0.30), time to initiation of medications (P=0.13), and number of medications (P=0.22) were comparable. Hypertensive phase was slightly but insignificantly more common with standard surgery (82%) as compared with MMC-augmented (60%) and AMT-augmented (70%) procedures (P=0.23). Complications were comparable over 1 year (P=0.28). Although adjunctive MMC and AMT were safe during AGV implantation, they did not influence success rates or intraocular pressure outcomes. Complications, including hypertensive phase, were also comparable.

  12. Outcomes of using a sutureless bovine pericardial patch graft for Ahmed glaucoma valve implantation.

    Science.gov (United States)

    Quaranta, Luciano; Riva, Ivano; Floriani, Irene C

    2013-01-01

    To evaluate the long-term outcomes of a surgical technique using a sutureless bovine pericardial patch graft for the implantation of an Ahmed glaucoma valve (AGV). 
 This was a pilot study on patients with primary open-angle glaucoma refractory to repeated surgical filtering procedures. All patients underwent AGV implant technique using a sutureless bovine pericardial patch graft. The pericardial membrane was cut using an ordinary corneal trephine with a diameter of 9.0 or 10.0 mm. The anterior part of the tube was covered with the graft and kept in place with fibrin glue. Subsequently, the cap was stitched all around the tube and the dissected conjunctiva was laid over it. Intraocular pressure (IOP) and complications were evaluated 1 week and 1, 3, 6, 12, and 24 months after surgery.
 The procedure was used to treat 20 eyes of 20 consecutive patients (12 men and 8 women: mean age [SD] 64.8 [7.8] years). Mean IOP was 28.1 mm Hg (SD 4.9) at baseline and decreased to 14.9 mm Hg (SD 1.5) 24 months after surgery (p<0.001). The overall mean number of topical medications was 3.1 (SD 0.5) at baseline and decreased to 1.4 (SD 0.8) after 24 months (p<0.001). During follow-up, there was no conjunctival erosion, thinning of pericardial patch graft over the tube, or tube exposure; no signs of endophthalmitis were recorded.
 The results suggest that the sutureless technique using a bovine pericardial graft patch is a safe and rapid procedure for AGV implantation.

  13. [Clinical efficacy and safety of FP-7 Ahmed glaucoma valve implantation in neurovascular glaucoma patients].

    Science.gov (United States)

    Bai, Yu-jing; Wang, Mei; Li, Yi-qing; Chai, Fang; Wei, Yan-tao; Zhang, Yi-chong; Yang, Xue-jiao; Ge, Jian; Zhuo, Ye-hong

    2011-10-01

    To evaluate the efficacy and safety of FP-7 Ahmed glaucoma valves (AGV) implantation in neurovascular glaucoma (NVG) as the first choice of surgery. This retrospective, comparative case series study collected a total of 36 eyes of 36 patients with neurovascular glaucoma who underwent AGV implantation in Zhongshan Ophthalmic Center from January 2009 to June 2010. Change of intraocular pressure (IOP), the best corrected visual acuity, numbers of anti-glaucoma medication, success rate and postoperative complications were followed up at day 1, week 1, month 1, and every 3 months after surgery. Complete success of surgery was rated as reduction of IOP ≥ 30% without medication and those who failed to meet criteria was rated as partial success. Data were analyzed by paired Student t-test for IOP, rank sum test for paired non-parametric numbers of medication, and repeated measures analysis of variance for comparison of IOP between different time points using SPSS 13.0. Compared with pre-operation, IOP was significant (F = 9.26, P AGV implantation (39.5 ± 9.7) mm Hg (1 mm Hg = 0.133 kPa) vs (9.2 ± 8.9), (11.8 ± 3.8), (13.7 ± 4.8), (16.9 ± 5.3), (16.9 ± 6.8) mm Hg at day 1, week 1, month 1, month 3 and the last following-up of post-operation, respectively. The numbers of anti-glaucoma medication were significantly (Z = 6.764, P AGV implantation was 80.6%, and qualified success rate was 91.7%. The postoperative complications including occlusion of the drainage tube, exposure of the drainage tube, shallow anterior chamber and encapsulated cystic blebs around the plate were controlled with additional treatment. The clinical outcome indicated that the implantation of FP-7 AGV has a stable IOP lowering effect and fewer complications, which can be considered as one of the first choices for management of NVG.

  14. The balloon-expandable Edwards Sapien 3 valve is superior to the self-expanding Medtronic CoreValve in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation.

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    Gonska, Birgid; Seeger, Julia; Baarts, Justus; Rodewald, Christoph; Scharnbeck, Dominik; Rottbauer, Wolfgang; Wöhrle, Jochen

    2017-06-01

    Residual paravalvular moderate or severe aortic regurgitation (AR) has been an independent risk factor for mortality after transcatheter aortic valve implantation (TAVI). The design of the third generation Edwards Sapien 3 (ES3; Edwards Lifesciences, Irvine, CA, USA) valve was optimized with an outer skirt to address the issue of paravalvular AR. We compared 100 consecutive patients treated with the ES3 for severe aortic stenosis with 100 patients treated with the Medtronic CoreValve (CV; Medtronic, Minneapolis, MN, USA) (Clinical Trial Registration: NCT02162069). We evaluated post-procedural AR, rate of permanent pacemaker implantation, device success, and 30-day clinical outcome according to the criteria of the Second Valve Academic Research Consortium (VARC-2). Frequency of post-procedural moderate or severe AR was significantly lower with ES3 compared to CV (0% vs. 20%, p<0.01), none or trace AR significantly higher with ES3 (69% vs. 38%, p<0.01) as well as device success (97% vs. 73%, p<0.01). There was a significantly lower need for permanent pacemaker implantation with ES3 compared with CV (14% vs. 31%, p<0.01). Cardiovascular mortality at 30 days was significantly lower with ES3 (0% vs. 6%, p=0.01), and the combined endpoint "early safety" was met significantly less with ES3 (10% vs. 21% with CV, p=0.03). Transfemoral TAVI with the ES3 compared with the CV was associated with a significantly lower rate of moderate or severe AR, significantly lower need for pacemaker implantation, and a significantly higher rate of device success according to VARC-2. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  15. Long-Term Outcomes of 560 Consecutive Patients Treated With Transcatheter Aortic Valve Implantation and Propensity Score-Matched Analysis of Early- Versus New-Generation Valves.

    Science.gov (United States)

    Levi, Amos; Landes, Uri; Assali, Abid R; Orvin, Katia; Sharony, Ram; Vaknin-Assa, Hanna; Hamdan, Ashraf; Shapira, Yaron; Schwartzenberg, Shmuel; Codner, Pablo; Shaul, Aviv A; Vaturi, Mordechai; Gutstein, Ariel; Sagie, Alexander; Kornowski, Ran

    2017-06-01

    Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis in patients at high or prohibitive surgical risk. Nevertheless, long-term clinical and echocardiographic data are still lacking. We carried out an analysis of 560 consecutive patients who underwent TAVI at our institution from 2008 to 2016 to evaluate temporal changes in TAVI characteristics, predictors of 1-year and long-term outcomes, and to compare the performance of the early- and new-generation valve systems. With time, we have adopted lower risk threshold for patient selection and have been using conscious sedation and transfemoral access preferentially (p <0.001 for all). The incidence of greater than mild PVL decreased from 16% to 7.6%, p = 0.029. Within 5 years, 47% of the patients died, the majority (78%) due to noncardiac causes. Independent predictors of 1-year death included periprocedural aspects (i.e., vascular complications, stroke, and PVL), whereas death occurring later than 1 year was solely related to baseline co-morbidities. Transvalvular gradients and residual regurgitation remained nonclinically significant for up to 5 years of follow-up. New-generation valves were associated with less PVL compared with propensity score-matched early-generation valves (p <0.001). In conclusion, TAVI utilization at our institution has progressed to include lower risk patients with transfemoral access becoming applicable in the great majority. Poor long-term survival is attributable to population factors rather than to procedural factors. Intermediate- and long-term hemodynamics are excellent. PVL has diminished significantly with the new-generation valves. Efforts to improve long- and short-term outcomes remain a therapeutic challenge. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Long-term follow-up after implantation of the Shelhigh (R) No-React (R) complete biological aortic valved conduit

    NARCIS (Netherlands)

    Reineke, David C.; Kaya, Abdullah; Heinisch, Paul P.; Oezdemir, Berna; Winkler, Bernhard; Huber, Christoph; Heijmen, Robin H.; Morshuis, Wim; Carrel, Thierry P.; Englberger, Lars

    2016-01-01

    OBJECTIVES: Long-term follow-up reports after implantation of the Shelhigh (R) (Shelhigh, Inc., NJ, USA) No-React (R) aortic valved conduit used for aortic root replacement do not exist. METHODS: Between November 1998 and December 2007, the Shelhigh (R) No-React (R) aortic valved conduit was

  17. Robot-assisted aortic valve replacement using a novel sutureless bovine pericardial prosthesis: proof of concept as an alternative to percutaneous implantation.

    Science.gov (United States)

    Suri, Rakesh M; Burkhart, Harold M; Schaff, Hartzell V

    2010-11-01

    : Percutaneous aortic valve implantation within native valve calcium has progressed to clinical use despite the absence of data proving equivalence to complete surgical excision and prosthetic valve replacement. A novel self-expanding sutureless bovine pericardial prosthesis (Sorin Perceval) derived from a proven stented valve has been successfully used in humans recently through an open transaortic approach. We sought to develop a minimally invasive technique for native aortic valve excision and sutureless prosthetic aortic valve replacement using robot assistance. : The da Vinci S-HD system was used to open and suspend the pericardium anterior to the phrenic nerve in cadavers. A transthoracic cross-clamp was placed across the midascending aorta, following which a transverse aortotomy was made. The native aortic valve cusps were excised, and annular calcium was removed with robotic instruments. After placement of three guide sutures, the Perceval self-expanding pericardial prosthesis mounted on a flexible delivery system was inserted through a working port and lowered into the aortic annulus. : Successful implantation of all valves was possible using a 3-cm right second intercostal space working port, along with two additional 1-cm instrument ports. A standard transverse aortotomy was sufficient for examination/debridement of the native aortic valve cusps, sizing of the annulus, and deployment of the nitinol-stented, bovine pericardial prosthesis. Delivery, seating, and stability of the device were easily confirmed above and below the aortic valve annulus using the robotic camera. : Complete excision of diseased native aortic valve cusps with robot assistance facilitates accurate and reproducible aortic valve replacement using a novel self-expanding sutureless version of a proven bovine pericardial prosthesis. This approach is comparable to the current surgical gold standard and is ready for clinical use as an alternative to percutaneous aortic valve implantation.

  18. Aortic valve bypass

    DEFF Research Database (Denmark)

    Lund, Jens T; Jensen, Maiken Brit; Arendrup, Henrik

    2013-01-01

    In aortic valve bypass (AVB) a valve-containing conduit is connecting the apex of the left ventricle to the descending aorta. Candidates are patients with symptomatic aortic valve stenosis rejected for conventional aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI...

  19. Direct Aortic CoreValve implantation via right anterior thoracotomy in a patient with patent bilateral mammary artery grafts and aortic arch chronic dissection

    Directory of Open Access Journals (Sweden)

    Giuseppe Bruschi

    2015-01-01

    Full Text Available Direct aortic trans-catheter aortic valve implantation is an alternative approach to treat high risk for surgery patients affected by severe aortic stenosis and concomitant peripheral vascular disease. We describe a case of direct aortic CoreValve implantation made via a right anterior thoracotomy in a 78-year-old male affected by severe aortic stenosis and severe peripheral vasculopathy, who previously underwent coronary artery bypass grafting, with patent bilateral mammary artery grafts and chronic aortic arch dissection.

  20. Graft-free Ahmed valve implantation through a 6 mm scleral tunnel.

    Science.gov (United States)

    Gdih, Gdih; Jiang, Kailun

    2017-02-01

    To evaluate the safety, efficacy, and cost savings of Ahmed glaucoma valve (AGV) tube implantation through a 6-mm scleral tunnel (graft-free technique). Retrospective cohort study. The 95% confidence interval for fractional survival at any particular time was calculated using the Kaplan-Meier method. Failure was defined as (i) intraocular pressure (IOP) 21 mm Hg or AGV with a success rate of 83% at 2 years. Fourteen eyes failed: 4 no light perception, 1 hypotony, 1 elevated IOP, 5 secondary glaucoma surgeries, 2 AGV extractions, and 1 corneal decompensation. The rate of transient hypotony peaked at 33% on postoperative day 1, reducing to 4% by 6 weeks. Transient flat anterior chamber developed in 8% of eyes. Eight percent of eyes experienced a hypertensive phase (mean IOP = 28 mm Hg). Preoperatively, eyes received 3.8 units of glaucoma medication on average. Postoperatively, 8 eyes required no medication for IOP control. Of the eyes requiring postoperative glaucoma medication, 33% restarted during week 4; an additional 25% of eyes were restarted 6 weeks postoperatively. By 6 months, eyes were on average using 2.2 units of glaucoma medication. Hyphema (18%) was the most common early postoperative complication. The rates of conjunctival and scleral erosion by 2 years were 2.4% and 0%, respectively. Within our institution, excluding valve cost, there was a 39%-45% ($192-$376) cost reduction with the graft-free technique. The safety and efficacy of a 6-mm scleral tunnel is comparable to conventional scleral-graft method. Copyright © 2017 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

  1. Outcomes of Ahmed valve implant following a failed initial trabeculotomy and trabeculectomy in refractory primary congenital glaucoma.

    Science.gov (United States)

    Dave, Paaraj; Senthil, Sirisha; Choudhari, Nikhil; Sekhar, Garudadri Chandra

    2015-01-01

    The aim was to report the outcome of Ahmed glaucoma valve (AGV) (New World Medical, Inc., Rancho Cucamonga, CA, USA) implantation as a surgical intervention following an initial failed combined trabeculotomy + trabeculectomy (trab + trab) in refractory primary congenital glaucoma (RPCG). Retrospective chart review of 11 eyes of 8 patients who underwent implantation of AGV (model FP8) for RPCG between 2009 and 2011. Prior trab + trab had failed in all the eyes. Success was defined as an intraocular pressure (IOP) >5 and ≤ 18 mmHg during examination under anesthesia with or without medications and without serious complications or additional glaucoma surgery. The mean age at AGV implantation was 15.4 ± 4.9 months. The mean preoperative IOP was 28 ± 5.7 mmHg which reduced to 13.6 ± 3.4 mmHg postoperatively at the last follow-up (P AGV implant was successful in a significant proportion of cases.

  2. Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures.

    Science.gov (United States)

    Milano, Carmelo; Pagani, Francis D; Slaughter, Mark S; Pham, Duc Thinh; Hathaway, David R; Jacoski, Mary V; Najarian, Kevin B; Aaronson, Keith D

    2014-09-09

    Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail. Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.6%) underwent isolated HeartWare Ventricular Assist Device implantation, 75 (19.6%) a concurrent valve procedure, and 45 (11.8%) concurrent nonvalvular procedures. Of the concurrent valve procedures, 56 were tricuspid, 13 aortic, and 6 mitral. Survival was similar between groups (79% for concurrent valve procedures and 85% for HeartWare Ventricular Assist Device only at 1 year; P=0.33). Concurrent valve procedures were also associated with increased unadjusted early right heart failure (RHF). A multivariable analysis for death and RHF (121 total events) identified female sex (odds ratio=2.0 [95% confidence interval, 1.2-3.3; P=0.0053]) and preimplant tricuspid regurgitation severity (odds ratio=2.9 [95% confidence interval, 1.8-4.8, PRHF compared with those who received TVP (0.19 versus 0.05 events per patient-year, respectively; P=0.024). Compared with HeartWare Ventricular Assist Device alone, survival was equivalent for the concurrent valve procedure group. Tricuspid regurgitation severity was the most important predictor of increased postoperative RHF, and concurrent TVP was not an independent predictor of RHF overall. Concurrent TVP may reduce the rate of late RHF for patients with significant preimplant tricuspid insufficiency. http://www.clinicaltrials.gov. Unique identifier: NCT00751972. © 2014 American Heart Association, Inc.

  3. Safety and efficacy of using the Viabahn endoprosthesis for percutaneous treatment of vascular access complications after transfemoral aortic valve implantation

    DEFF Research Database (Denmark)

    De Backer, Ole; Arnous, Samer; Sandholt, Benjamin

    2015-01-01

    Vascular access complications (VACs) remain one of the biggest challenges when performing transcatheter aortic valve implantation (TAVI). This study aimed to investigate the short- and medium-term safety and efficacy of the Viabahn endoprosthesis (Gore, Flagstaff, AZ) when used to treat TAVI......-induced vascular injury. Over a 40-month period, 354 patients underwent true percutaneous transfemoral (TF)-TAVI using a CoreValve and Prostar-XL closure system; this was our study population. A VAC leading to acute intervention occurred in 72 patients (20.3%) - of these, 18 were managed by balloon angioplasty, 48...... stenting versus patients without vascular complications. Two patients (4.5%) presented with new-onset claudication; one of them had the stent implanted covering the deep femoral artery (DFA). At medium-term follow-up (median 372 days; range 55 to 978 days) duplex ultrasound showed 100% patency...

  4. Effect of mitomycin c and 5-flurouracil adjuvant therapy on the outcomes of Ahmed glaucoma valve implantation.

    Science.gov (United States)

    Cui, Qi N; Hsia, Yen C; Lin, Shan C; Stamper, Robert L; Rose-Nussbaumer, Jennifer; Mehta, Nitisha; Porco, Travis C; Naseri, Ayman; Han, Ying

    2017-03-01

    To examine the effect of mitomycin c and 5-flurouracil on treatment outcomes following Ahmed glaucoma valve implantation. Retrospective consecutive case series. Fifty patients who received Ahmed glaucoma valve implantation from 1999 to 2013 in the San Francisco Veterans Administration Hospital. The +INJECTION group received intraoperative mitomycin c followed by postoperative mitomycin c and/or 5-flurouracil, whereas the -INJECTION group did not. Primary outcome was treatment success at 1 year post-implantation. Intraocular pressure, hypertensive phase, and the number of glaucoma medications were also examined. Twenty-six patients/eyes in the +INJECTION group and 24 patients/eyes in the -INJECTION group were included. Treatment success was higher in the +INJECTION compared with the -INJECTION group (86 vs. 58%; P = 0.04). Intraocular pressure was lower in the +INJECTION compared with the -INJECTION group at 1, 3, 6 and 12 months (P ≪ 0.00001, P = 0.00003, 0.0008 and 0.024). Hypertensive phase occurred less often in the +INJECTION compared with the -INJECTION group (3.8 vs. 54%; P = 0.021). The +INJECTION group required fewer medications compared with the -INJECTION group (P = 0.02, 0.002, 0.003 and 0.008 at 1, 3, 6 and 12 months). Complication rates were comparable between groups (46.2 and 54.2%; P = 0.63). Adjuvant treatment with antifibrotics following Ahmed glaucoma valve implantation decreased the hypertensive phase and improved surgical outcomes without impacting complication rates at 1 year. This study postulates a role for antifibrotics in the postoperative management of Ahmed glaucoma valves. © 2016 Royal Australian and New Zealand College of Ophthalmologists.

  5. Transfemoral transcatheter aortic valve implantation in patients with small diseased peripheral vessels

    Energy Technology Data Exchange (ETDEWEB)

    Ruparelia, Neil [San Raffaele Scientific Institute, Milan (Italy); Imperial College, London (United Kingdom); Buzzatti, Nicola; Romano, Vittorio; Longoni, Matteo; Figini, Fillipo; Montorfano, Matteo; Kawamoto, Hiroyoshi; Miyazaki, Tadashi; Spagnolo, Pietro; Alfieri, Ottavio; Colombo, Antonio [San Raffaele Scientific Institute, Milan (Italy); Latib, Azeem, E-mail: info@emocolumbus.it [San Raffaele Scientific Institute, Milan (Italy)

    2015-09-15

    Objectives: The aim of this study was to assess the feasibility, safety and short-term outcomes of transfemoral transcatheter aortic valve implantation (TF-TAVI) in patients with small diseased peripheral vessels. Background: The transfemoral (TF) route for transcatheter aortic valve (TAVI) is the default option due to associated advantages. However, this is limited due to the high prevalence of significant peripheral arterial disease and increased risk of vascular complications. Methods: Of 539 consecutive patients undergoing TAVI in a single Italian center, 23 patients underwent TF-TAVI in the presence of small peripheral vessels as defined by a minimal luminal diameter (MLD) of ≤ 5.5 mm [by computed tomography (CT)] and/or the inability to advance a large-bore sheath. Calcification was defined as being concentric if calcium extended more than 270° around the circumference of the artery. All patients underwent 30-day clinical follow-up. Results: 17 (73.9%) patients underwent peripheral vessel pre-dilatation with a semi-compliant balloon and 6 (26.1%) patients with a Solopath sheath. 6 (26.1%) patients suffered a peri-procedural complication, with 1 patient requiring surgical embolectomy for thrombotic occlusion and the remaining patients successfully managed percutaneously in the catheter laboratory. No patient suffered a vessel perforation or required implantation of a covered stent. At 30-day follow-up, all patients were free of symptoms and signs or symptoms of peripheral vascular disease, with well-functioning TAVI prostheses as evaluated by echocardiography. Conclusions: Performing TF-TAVI is feasible in patients with no other viable vascular access option in the presence of small MLD and calcification of the peripheral vasculature, with any anticipated acute vascular complication managed in the catheter laboratory with established percutaneous techniques. - Highlights: • Small peripheral vessels is regarded as contraindication to transfemoral TAVI.

  6. [Quality in aortic valve replacement--how good have hybrid valves have to be?].

    Science.gov (United States)

    Aicher, D; Groesdonk, H V; Schäfers, H-J

    2009-10-01

    The current enthusiasm with the development of catheter-based aortic valve replacement suggests a critical appraisal of the quality of conventional techniques. Currently surgical treatment of diseased aortic valves includes different methods that can be employed with a low risk. Risk prediction is difficult, the Euroscore largely overestimates mortality. By comparison, there is no evidence that the risk of implantation is reduced by catheter-based implantation. Specific complications (stroke, AV-block, perivalvular leak) are more frequent compared to conventional replacement. Despite the current enthusiasm over the feasibility of catheter-based implantation of hybrid aortic valves they should still be used cautiously. Georg Thieme Verlag KG Stuttgart, New York.

  7. Prognostic performance of critical care scores in patients undergoing transcatheter aortic valve implantation.

    Science.gov (United States)

    Georgiadou, Panagiota; Analitis, Antonis; Sbarouni, Eftihia; Voudris, Vassilis

    2016-08-01

    Critical care management of patients undergoing transcatheter aortic valve implantation (TAVI) is a major determinant of their outcome. The aim of this study was to compare the prognostic performance of four general scoring systems [Acute Physiology and Chronic Health Evaluation (APACHE), Simplified Acute Physiology Score (SAPS), Sequential Organ Failure Assessment (SOFA), and MultiOrgan Dysfunction (MOD) scores] in TAVI patients. Between 1 June 2008 and 30 June 2014, 75 patients (81.2 ± 6.4 years old, 36 men and 39 women) who underwent TAVI were scored during the first 24 h of their stay at the intensive care unit (ICU). The outcome measures were in-hospital and 30-day mortality and in-hospital and 30-day morbidity defined as myocardial infarction, implantation of permanent pacemaker, stroke, tamponade, major bleeding, vascular access site complications and prolonged ventilation. Four patients (5.3%) died in ICU and one more during follow-up, indicating a 30-day mortality rate of 6.6%. Regarding in-hospital mortality, the area under the ROC curve (AUC) was 0.92 for SAPS II, 0.88 for APACHE II, 0.73 for MODS and 0.74 for SOFA. Regarding 30 day-mortality, SAPS II and APACHE II performed equally higher (AUC = 0.88) than the other two scores (0.79 for MODS and 0.80 for SOFA). SAPS II had the best calibration among all four scores for in-hospital and 30-day mortality ( χ 2  = 3.06 and χ 2  = 3.29, respectively). AUCs for in-hospital and 30-day morbidity were above 0.7 for SAPS II and APACHE II. SAPS II and APACHE II are reliable mortality and morbidity risk stratification models for TAVI patients with high calibration and discrimination.

  8. Adjunctive triamcinolone acetonide for Ahmed glaucoma valve implantation: a randomized clinical trial.

    Science.gov (United States)

    Yazdani, Shahin; Doozandeh, Azadeh; Pakravan, Mohammad; Ownagh, Vahid; Yaseri, Mehdi

    2017-06-26

    To evaluate the effect of intraoperative sub-Tenon injection of triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation. In this triple-blind randomized clinical trial, 104 eyes with refractory glaucoma were randomly assigned to conventional AGV (non-TA group) or AGV with adjunctive triamcinolone (TA group). In the TA group, 10 mg TA was injected in the sub-Tenon space around the AGV plate intraoperatively. Patients were followed for 1 year. The main outcome measure was intraocular pressure (IOP). Other outcome measures included best-corrected visual acuity (BCVA), occurrence of hypertensive phase (HP), peak IOP, number of antiglaucoma medications, and complications. A total of 90 patients were included in the final analysis. Mean IOP was lower in the TA group at most follow-up visits; however, the difference was statistically significant only at the first month (p = 0.004). Linear mixed model showed that mean IOP was 1.5 mm Hg lower in the TA group throughout the study period (p = 0.006). Peak postoperative IOP was significantly lower in the TA group (19.3 ± 4.8 mm Hg versus 29 ± 9.2 mm Hg, p = 0.032). Rates of success (defined as 6 2 lines was more common in the non-TA group (p = 0.032). Adjunctive intraoperative TA injection during AGV implantation can blunt peak IOP levels and reduce mean IOP up to 1 year. Visual outcomes also seem to be superior to standard surgery.

  9. Prediction of bone density around orthopedic implants delivering bisphosphonate.

    Science.gov (United States)

    Stadelmann, Vincent A; Terrier, Alexandre; Gauthier, O; Bouler, J-M; Pioletti, Dominique P

    2009-06-19

    The fixation of an orthopedic implant depends strongly upon its initial stability. Peri-implant bone may resorb shortly after the surgery. This resorption is directly followed by new bone formation and implants fixation strengthening, the so-called secondary fixation. If the initial stability is not reached, the resorption continues and the implant fixation weakens, which leads to implant loosening. Studies with rats and dogs have shown that a solution to prevent peri-implant resorption is to deliver bisphosphonate from the implant surface. The aims of the study were, first, to develop a model of bone remodeling around an implant delivering bisphosphonate, second, to predict the bisphosphonate dose that would induce the maximal peri-implant bone density, and third to verify in vivo that peri-implant bone density is maximal with the calculated dose. The model consists of a bone remodeling equation and a drug diffusion equation. The change in bone density is driven by a mechanical stimulus and a drug stimulus. The drug stimulus function and the other numerical parameters were identified from experimental data. The model predicted that a dose of 0.3 microg of zoledronate on the implant would induce a maximal bone density. Implants with 0.3 microg of zoledronate were then implanted in rat femurs for 3, 6 and 9 weeks. We measured that peri-implant bone density was 4% greater with the calculated dose compared to the dose empirically described as best. The approach presented in this paper could be used in the design and analysis processes of experiments in local delivery of drug such as bisphosphonate.

  10. Incidence of Postoperative Delirium and Its Impact on Outcomes After Transcatheter Aortic Valve Implantation.

    Science.gov (United States)

    Bagienski, Maciej; Kleczynski, Pawel; Dziewierz, Artur; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Dudek, Dariusz

    2017-10-01

    There are limited data on the occurrence of postoperative delirium after transcatheter aortic valve implantation (TAVI). We sought to investigate the incidence of delirium after TAVI and its impact on clinical outcomes. A total of 148 consecutive patients who underwent TAVI were enrolled. Of these patients, 141 patients survived hospital stay. The incidence of delirium was assessed in these patients for the first 4 days after the index procedure. The patients were divided into 2 groups based on the presence of delirium. Baseline characteristics, procedural and long-term outcomes, and frailty and quality-of-life indexes were compared among the groups. Of the 141 patients analyzed, 29 patients developed delirium. The transapical access was more common in patients with delirium (51.7% vs 8.9%, p delirium group was noted (75 vs 100 ml, p = 0.001). Significantly more patients with delirium were considered as frail before TAVI. Thirty-day and 12-month all-cause mortality rates were higher in the delirium group (0.0% vs 17.2%, p delirium after TAVI. Importantly, the occurrence of delirium after TAVI may help to identify patients with worse short- and long-term outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. Efficacy and Safety of Transcatheter Aortic Valve Implantation in Aortic Stenosis Patients With Extreme Age.

    Science.gov (United States)

    Orvin, Katia; Assali, Abid; Vaknin-Assa, Hana; Levi, Amos; Greenberg, Gabi; Codner, Pablo; Shapira, Yaron; Sagie, Alex; Kornowski, Ran

    2015-10-01

    To investigate the in-hospital and long-term outcomes of patients at extreme age with severe symptomatic aortic stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI). A total of 276 consecutive patients with a mean age of 82.2 ± 5.0 years with severe symptomatic AS underwent TAVI at our institute. We evaluated periprocedural, in-hospital, and long-term outcomes in all patients aged ≥87 years (the highest 20th percentile of age distribution) and compared them with the less elderly patients. The extremely aged group included 58 patients (21%) ≥87 years (mean age, 89.0 ± 1.9 years; 67.2% women). Baseline EuroSCOREs and STS scores were 19.6 ± 11.2% and 9.4 ± 5.0%, respectively. Nineteen patients (34.5%) were considered frail. Following TAVI, all patients regained New York Heart Association class 1-2 functional capacity. The main periprocedural and in-hospital complications were minor vascular complications, bleeding requiring blood transfusions, and the need for permanent pacemaker. None of the patients suffered from clinical stroke. In comparison to the less elderly patients, there were no significant differences in the rates of periprocedural, in-hospital complications or long-term survival (log rank, 0.87). Meticulously selected patients at extreme age benefit from TAVI with a reasonable overall risk, which does not impact the overall survival or functional status.

  12. Transapical aortic valve implantation: learning curve with reduced operating time and radiation exposure.

    Science.gov (United States)

    D'Ancona, Giuseppe; Pasic, Miralem; Unbehaun, Axel; Dreysse, Stephan; Drews, Thorsten; Buz, Semih; Kukucka, Marian; Mladenow, Alexander; Hetzer, Roland; Seifert, Burkhardt

    2014-01-01

    The purpose of this study was to test whether, and in which terms, the cumulative institutional experience in the field of transapical transcatheter aortic valve implantation (TAVI) might impact upon operative time and radiation exposure. This was a retrospective, single-center, observational cohort study of prospectively collected data from all 500 consecutive high-risk patients undergoing transapical TAVI at our institution between April 2008 and December 2011. Differences during the study period in baseline characteristics, procedural and post-procedural variables, and survival were analyzed. Nonparametric correlation and linear regression analyses were used to identify changes in operative time, contrast agent use, and radiation exposure according to institutional cumulative experience. Median operating time was 90 minutes (interquartile range 75-115 min) and fluoroscopy time was 6.7 minutes (4.8-10.3 min). Combined planned percutaneous coronary intervention was performed in 57 (11.4%) patients. There was a significant correlation between operating time, fluoroscopy time, and institutional experience. A 5% reduction in operating time (95% CI 3% to 8%, p exposure time (95% CI 12% to 18%, p operating time and radiation exposure are contained and reduced over the entire observation time in 500 consecutive patients. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  13. Corneal Biomechanical Changes Following Trabeculectomy, Phaco-trabeculectomy, Ahmed Glaucoma Valve Implantation and Phacoemulsification.

    Science.gov (United States)

    Pakravan, Mohammad; Afroozifar, Mohsen; Yazdani, Shahin

    2014-01-01

    To determine corneal biomechanical changes following major glaucoma procedures. In a prospective comparative case series, corneal biomechanical properties were assessed using the Ocular Response Analyzer (ORA, Reichert Inc., Depew, New York, USA) before and 3 months after surgery in 89 eyes of 89 patients undergoing trabeculectomy + mitomycin C (MMC) (23 eyes, group 1), phacotrabeculectomy + MMC (23 eyes; group 2), Ahmed glaucoma valve (AGV) implantation (17 eyes; group 3) or phacoemulsification (PE) alone (26 non-glaucomatous eyes; group 4). Patients with history of contact lens use, previous intraocular surgery, any chronic corneal disease, central corneal thickness ≥580 microns or ≤500 microns, post-operative intraocular pressure (IOP) > 21 mmHg or ≤ 5 mmHg, and any surgical complication were excluded. Main outcome measures included changes in corneal hysteresis (CH) and corneal resistance factor (CRF). Preoperatively, CH was lower in glaucomatous versus non-glaucomatous eyes (5.4, 5.3, 5.2 and 8.1 mmHg in groups 1, 2, 3 and 4 respectively, pglaucoma procedures. Alterations in corneal biomechanical properties should be considered when measuring IOP after successful glaucoma surgery.

  14. The relationship between chronic obstructive pulmonary disease and transcatheter aortic valve implantation--A systematic review and meta-analysis.

    Science.gov (United States)

    Liao, Yan-Biao; He, Ze-Xia; Zhao, Zhen-Gang; Wei, Xin; Zuo, Zhi-Liang; Li, Yi-Jian; Xiong, Tian-Yuan; Xu, Yuan-Ning; Feng, Yuan; Chen, Mao

    2016-03-01

    The present study was performed to investigate the relationship between chronic obstructive pulmonary disease (COPD) and transcatheter aortic valve implantation (TAVI). Controversies regarding the relationship between COPD and TAVI have intensified. A literature review of the PubMed online database was performed, and articles published between January 1, 2002 and March 20, 2015 were analyzed. Random-effect and fixed-effect models were used, depending on the between-study heterogeneity. A total of 28 studies, involving 51,530 patients, were identified in our review. The burden of COPD ranged from 12.5% to 43.4%, and COPD negatively impacted both short-term and long-term all-cause survival (30 days: odds ratio [OR], 1.43, 95% CI, 1.14-1.79; >2 years: hazard ratio [HR], 1.34, 95% CI, 1.12-1.61). COPD was also associated with increased short-term and mid-term cardiac-cause mortality (30 days: OR, 1.29, 95% CI, 1.02-1.64; 1 year: HR: 1.09, 1.02-1.17). Moreover, COPD (OR, 1.97, 95% CI, 1.29-3.0) predicted post-TAVI acute kidney disease. Importantly, chronic kidney disease (CKD) (HR, 1.2, 95% CI, 1.1-1.32) and the distance of the 6 minute walk test (6MWT) (HR, 1.16, 1.06-1.27) predicted TAVI futility in patients with COPD. COPD is common among patients undergoing TAVI, and COPD impacts both short- and long-term survival. COPD patients, who had a lower BMI, shorter distance of 6MWT and CKD, were at higher risk for TAVI futility. © 2016 Wiley Periodicals, Inc.

  15. Early safety outcome following transcatheter aortic valve implantation: is the amount of contrast media used a matter of concern?

    Science.gov (United States)

    Vontobel, Jan; Possner, Mathias; Schütz, Philipp; Müller, Beat; Taramasso, Maurizio; Binder, Roland K; Haueis, Sabine; Attinger-Toller, Adrian; Maisano, Francesco; Nietlispach, Fabian

    2015-01-01

    The study objective was to evaluate the impact of the amount of contrast medium used for transcatheter aortic valve implantation (TAVI) on short-term outcome. Patients undergoing TAVI are exposed to repeat contrast medium application both for preprocedural screening and during the TAVI procedure itself. Whether the amount of contrast media is associated with worse outcome is unclear. A total of 257 patients were included (median age 82.7 years) and divided into two groups with preserved and reduced kidney function (glomerular filtration rate contrast media administered during and within 5 days prior to TAVI was analysed. A combined early safety endpoint at 30 days was evaluated. The early safety endpoint was reached by 31 patients and acute kidney injury occurred in 22 patients. The median total volume of contrast media administered was 144 ml (interquartile range 81-225 ml). The amount of contrast did not independently predict the early safety endpoint in the overall population (odds ratio [OR] 0.93, 95% confidence interval [CI] 0.56 to 1.53, p = 0.774) and in subgroups with preserved and reduced kidney function. Change in creatinine was an independent strong predictor of the early safety endpoint in the overall population (OR 18.13, 95% CI 4.70 to 69.99, p contrast did not predict a change in creatinine within 72 hours following TAVI (r = 0.02, 95% CI -0.02 to 0.07, p = 0.368). Decreased kidney function after TAVI influences outcome. When rather small amounts of contrast media are used for screening and the TAVI procedure itself, the amount of contrast media seems not to be an independent predictor of outcome, further suggesting that decreased kidney function after TAVI is multifactorial.

  16. Severe conduction defects requiring permanent pacemaker implantation in patients with a new-onset left bundle branch block after transcatheter aortic valve implantation.

    Science.gov (United States)

    Nijenhuis, V J; Van Dijk, V F; Chaldoupi, S M; Balt, J C; Ten Berg, J M

    2017-06-01

    Transcatheter aortic valve implantation (TAVI) is frequently associated with cardiac conduction defects (CCD) requiring permanent pacemaker implantation (PPI). Although new-onset left bundle branch block (LBBB) is often seen, the rate of progression to severe CCD is unclear. We aimed to find clinical and electrocardiographic (ECG) parameters associated with severe CCD requiring PPI in patients with a new-onset LBBB after TAVI and assess its effect on clinical outcome. All consecutive patients undergoing TAVI who developed a new-onset LBBB were retrospectively analysed. We excluded patients with pre-existing bundle branch block or pacemaker. Patients were divided into two groups: with or without PPI after TAVI. We included 155 patients (50% female, 80 ± 7 years), of which 37 (24%) developed CCD requiring PPI, mainly due to a total atrioventricular block (n = 17; 46%). Cardiac conduction defects requiring PPI were associated with the following pre-existing parameters: atrial fibrillation (AF), the use of digoxin, CoreValve implantation, and left heart axis. Furthermore, it was associated with the following post-procedural parameters: left heart axis, lower mean heart rate, and prolonged PQ and QRS times. During follow-up, patients with PPI showed a lower mortality rate (11 vs. 29%, P = 0.03). In patients without PPI, mortality was lower in those with narrower QRS complex and transient LBBB. The severity and persistence of a new-onset LBBB after TAVI is associated with mortality. Cardiac conduction defects requiring PPI are associated with prior AF, the use of digoxin, CoreValve implantation, and a left heart axis. In these patients, PPI portends a better prognosis than no PPI.

  17. Rationale and design of the Edwards SAPIEN-3 periprosthetic leakage evaluation versus Medtronic CoreValve in transfemoral aortic valve implantation (ELECT) trial : A randomised comparison of balloon-expandable versus self-expanding transcatheter aortic valve prostheses.

    Science.gov (United States)

    Abawi, M; Agostoni, P; Kooistra, N H M; Samim, M; Nijhoff, F; Voskuil, M; Nathoe, H; Doevendans, P A; Chamuleau, S A; Urgel, K; Hendrikse, J; Leiner, T; Abrahams, A C; van der Worp, B; Stella, P R

    2017-05-01

    Periprosthetic aortic regurgitation (PPR) after transcatheter aortic valve implantation (TAVI) remains an important issue associated with impaired long-term outcomes. The current randomised study aims to evaluate potential differences between the balloon-expandable Edwards SAPIEN-3 and the self-expanding Medtronic CoreValve system with the main focus on post-TAVI PPR by means of novel imaging endpoints, and an additional focus on other clinical endpoints. The primary endpoint of this study is quantitative assessment of the severity of post-procedural PPR using cardiac magnetic resonance imaging. Several other novel imaging modalities (X-ray contrast angiography, echocardiography) are used as secondary imaging modalities for the assessment of PPR following TAVI. Secondary objectives of the study include clinical outcomes such as cerebral and kidney injury related to TAVI, and quality of life. The ELECT study is a single-centre, prospective, two-armed randomised controlled trial. For the purpose of this study, 108 consecutive adult patients suitable for transfemoral TAVI will be randomly allocated to receive the SAPIEN-3 (n = 54) or the CoreValve system (n = 54). The ELECT trial is the first randomised controlled trial to quantitatively compare the extent of post-TAVI PPR between the SAPIEN-3 and CoreValve. Furthermore, it will evaluate potential differences between the two prostheses with regard to mid-term clinical outcome and quality of life.

  18. Introducing transcatheter aortic valve implantation with a new generation prosthesis: Institutional learning curve and effects on acute outcomes.

    Science.gov (United States)

    D'Ancona, G; Agma, H U; Kische, S; El-Achkar, G; Dißmann, M; Ortak, J; Ince, H; Ketterer, U; Bärisch, A; Öner, A

    2017-02-01

    We present our single-centre experience with the direct flow medical (DFM) trans-catheter aortic valve implantation (TAVI) prosthesis addressing the impact of learning curve upon outcomes. The DFM has been recently introduced for TAVI. The prosthesis presents original design and implantation features. Patients were divided into three groups according to the chronological implantation sequence that reflected technical skills acquisition of the entire team. Group I included the first 20 patients (early learning phase), group II the second 20 patients (proctoring to other members of the team), and group III the following 93 patients (technique consolidation). Differences in baseline and procedural variables were analysed. Nonparametric correlation and linear regression were used to identify changes according to institutional cumulative experience. There was a significant correlation between catheterisation time and institutional experience (rho = -0.4; p proctoring and technical consolidation phase.

  19. Stem thrust prediction model for W-K-M double wedge parallel expanding gate valves

    Energy Technology Data Exchange (ETDEWEB)

    Eldiwany, B.; Alvarez, P.D. [Kalsi Engineering Inc., Sugar Land, TX (United States); Wolfe, K. [Electric Power Research Institute, Palo Alto, CA (United States)

    1996-12-01

    An analytical model for determining the required valve stem thrust during opening and closing strokes of W-K-M parallel expanding gate valves was developed as part of the EPRI Motor-Operated Valve Performance Prediction Methodology (EPRI MOV PPM) Program. The model was validated against measured stem thrust data obtained from in-situ testing of three W-K-M valves. Model predictions show favorable, bounding agreement with the measured data for valves with Stellite 6 hardfacing on the disks and seat rings for water flow in the preferred flow direction (gate downstream). The maximum required thrust to open and to close the valve (excluding wedging and unwedging forces) occurs at a slightly open position and not at the fully closed position. In the nonpreferred flow direction, the model shows that premature wedging can occur during {Delta}P closure strokes even when the coefficients of friction at different sliding surfaces are within the typical range. This paper summarizes the model description and comparison against test data.

  20. Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Implantation: Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Bagur, Rodrigo; Solo, Karla; Alghofaili, Saleh; Nombela-Franco, Luis; Kwok, Chun Shing; Hayman, Samual; Siemieniuk, Reed A; Foroutan, Farid; Spencer, Frederick A; Vandvik, Per O; Schäufele, Tim G; Mamas, Mamas A

    2017-05-01

    Silent ischemic embolic lesions are common after transcatheter aortic valve implantation (TAVI). The use of embolic protection devices (EPD) may reduce the occurrence of these embolic lesions. Thus, a quantitative overview and credibility assessment of the literature was necessary to draw a robust message about EPD. Therefore, the aim of this meta-analysis was to study whether the use of EPD reduces silent ischemic and clinically evident cerebrovascular events associated with TAVI. We conducted a comprehensive search to identify studies that evaluated patients undergoing TAVI with or without EPD. Random-effects meta-analyses were performed to estimate the effect of EPD compared with no-EPD during TAVI using aggregate data. Sixteen studies involving 1170 patients (865/305 with/without EPD) fulfilled the inclusion criteria. The EPD delivery success rate was reported in all studies and was achieved in 94.5% of patients. Meta-analyses evaluating EPD versus without EPD strategies could not confirm or exclude any differences in terms of clinically evident stroke (relative risk, 0.70; 95% confidence interval [CI], 0.38-1.29; P=0.26) or 30-day mortality (relative risk, 0.58; 95% CI, 0.20-1.64; P=0.30). There were no significant differences in new-single, multiple, or total number of lesions. The use of EPD was associated with a significantly smaller ischemic volume per lesion (standardized mean difference, -0.52; 95% CI, -0.85 to -0.20; P=0.002) and smaller total volume of lesions (standardized mean difference, -0.23; 95% CI, -0.42 to -0.03; P=0.02). Subgroup analysis by type of valve showed an overall trend toward significant reduction in new lesions per patient using EPD (standardized mean difference, -0.41; 95% CI, -0.82 to 0.00; P=0.05), driven by self-expanding devices. The use of EPD during TAVI may be associated with smaller volume of silent ischemic lesions and smaller total volume of silent ischemic lesions. However, EPD may not reduce the number of new

  1. Early Ahmed glaucoma valve implantation after penetrating keratoplasty leads to better outcomes in an Asian population with preexisting glaucoma.

    Directory of Open Access Journals (Sweden)

    Ming-Cheng Tai

    Full Text Available BACKGROUND: To evaluate the efficacy of Ahmed Glaucoma Valve (AGV surgery and the optimal interval between penetrating keratoplasty (PKP and AGV implantation in a population of Asian patients with preexisting glaucoma who underwent PKP. METHODOLOGY/PRINCIPAL FINDINGS: In total, 45 eyes of 45 patients were included in this retrospective chart review. The final intraocular pressures (IOPs, graft survival rate, and changes in visual acuity were assessed to evaluate the outcomes of AGV implantations in eyes in which AGV implantation occurred within 1 month of post-PKP IOP elevation (Group 1 and in eyes in which AGV implantation took place more than 1 month after the post-PKP IOP evaluation (Group 2. Factors that were associated with graft failure were analyzed, and the overall patterns of complications were reviewed. By their final follow-up visits, 58% of the patients had been successfully treated for glaucoma. After the operation, there were no statistically significant differences between the groups with respect to graft survival (p = 0.98, but significant differences for IOP control (p = 0.049 and the maintenance of visual acuity (VA (p21 mm Hg. The most common surgical complication, aside from graft failure, was hyphema. CONCLUSIONS/SIGNIFICANCE: Early AGV implantation results in a higher probability of AGV survival and a better VA outcome without increasing the risk of corneal graft failure as a result of post-PKP glaucoma drainage tube implantation.

  2. Risk of stroke after transcatheter prosthetic aortic valve implant with aortic bioprosthesis: subclinical thrombosis and possible therapeutic implications.

    Science.gov (United States)

    Di Pasquale, Giuseppe; Coutsoumbas, Gloria V; Zagnoni, Silvia

    2017-10-16

    : Many factors could increase the risk of stroke after transcatheter prosthetic aortic valve implant, mainly related to the procedure itself, or to the type of valvular prosthesis, or to the presence of atrial fibrillation. There is a wide variability in the antithrombotic treatment utilized in clinical practice, as far as the choice of drugs (anticoagulant, single or dual antiplatelet treatment), and its optimal duration. The most popular therapeutic strategy, also recommended by the Scientific Societies, is dual antiplatelet (aspirin and clopidogrel) for the first 3-6 months then switching to single antiplatelet (usually aspirin), limiting oral anticoagulant therapy only to those patients with other primary indication to the treatment. Recently, it has been outlined that subclinical thrombosis could be responsible for bioprosthetic valve malfunction, whereas some studies suggest the efficacy of a single antiplatelet drug after transcatheter prosthetic aortic valve implant. Therefore, it is possible to personalize the therapeutic regimen balancing the ischemic and hemorrhagic risk. Several studies are ongoing to overcome these therapeutic uncertainties, including the use of new oral anticoagulants.

  3. Stem thrust prediction model for Westinghouse wedge gate valves with linkage type stem-to-disk connection

    Energy Technology Data Exchange (ETDEWEB)

    Wang, J.K.; Sharma, V.; Kalsi, M.S. [Kalsi Engineering, Inc., Sugar Land, TX (United States)] [and others

    1996-12-01

    The Electric Power Research Institute (EPRI) conducted a comprehensive research program with the objective of providing nuclear utilities with analytical methods to predict motor operated valve (MOV) performance under design basis conditions. This paper describes the stem thrust calculation model developed for evaluating the performance of one such valve, the Westinghouse flexible wedge gate valve. These procedures account for the unique functional characteristics of this valve design. In addition, model results are compared to available flow loop and in situ test data as a basis for evaluating the performance of the valve model.

  4. Introducing transapical aortic valve implantation (part 2): institutional structured training program.

    Science.gov (United States)

    Pasic, Miralem; Unbehaun, Axel; Dreysse, Stephan; Buz, Semih; Drews, Thorsten; Kukucka, Marian; Mladenow, Alexander; Hetzer, Roland; D'Ancona, Giuseppe

    2013-04-01

    Introduction of a new procedure has a typical learning curve with the "learning phase" at the beginning, characterized by an increased mortality or complication rate. We developed our institutional structured training program for transcatheter aortic valve implantation (TAVI) with the aim of eliminating these negative effects. The program regulated the introduction of TAVI and building and training of the team. It combines cumulative knowledge from the field with the institutional and individual background experience. It includes stepwise acquisition of the tools necessary for the preoperative strategic planning, perioperative team communication, technical aspects of the procedure, and postoperative management. The program establishes a basis for interaction and feedback between the members of the team ("teach and learn"; "be proctor and proctored"). The program consists of 4 main parts: general principles, team building, team education and training, and the institutional clinical and procedural policies. The program possesses several control mechanisms, eg, occasional external proctoring. Additionally, a chain of steps spontaneously generates further procedural improvements and optimizes the overall outcome. The program has also had a global positive effect on the local institutional environment, awaking awareness of existing latent conditions and active failures, identifying them and inducing their correction, which has led to general clinical improvement. A structured educational training program enables implementation of a new procedure (TAVI) into clinical practice without increased morbidity and mortality rate during the learning curve. The program may also be used as a basis for any new device introduction into clinical practice. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  5. Prevalence of blood type A and risk of vascular complications following transcatheter aortic valve implantation.

    Science.gov (United States)

    Rofe, M-T; Shacham, Y; Steinvi, A; Barak, L; Hareuveni, M; Banai, S; Keren, G; Finkelstein, A; Shmilovich, H

    2016-05-01

    To assess the prevalence of blood type A among patients referred for transcatheter aortic valve implantation (TAVI) and whether it is related to vascular complications. Vascular complications following TAVI are associated with adverse outcomes. Various blood types, particularly type A, have been shown to be more prevalent in cardiovascular diseases and to be related to prognosis. The prevalence of various blood types in a cohort of 491 consecutive patients who underwent TAVI was compared with a control group of 6500 consecutive hospitalised patients. The prevalence and predictors of vascular complications and bleeding events were evaluated in the blood type A group and were compared with non-type A patients. The mean age of TAVI patients was 83 ± 6 years, and 40 % were males. Patients were divided into two groups: blood type A (n = 220) and non-type A (n = 271). Type A was significantly more prevalent in the TAVI group than in the control group (45 vs. 38 %, p = 0.023). Compared with the non-type A group, patients with blood type A had more major and fatal bleeding (14.5 vs. 8.1 %, p = 0.027) and more vascular complications (any vascular complication: 24.5 vs. 15.9 % p = 0.016; major vascular complications: 12.3 vs. 7 % p = 0.047). In a multivariable analysis, blood type A emerged as a significant and independent predictor for vascular complications and bleeding events. Blood type A is significantly more prevalent in TAVI patients than in the general population and is related to higher rates of vascular and bleeding complications.

  6. Intraocular pressure control after the implantation of a second Ahmed glaucoma valve.

    Science.gov (United States)

    Jiménez-Román, Jesús; Gil-Carrasco, Félix; Costa, Vital Paulino; Schimiti, Rui Barroso; Lerner, Fabián; Santana, Priscila Rezende; Vascocellos, Jose Paulo Cabral; Castillejos-Chévez, Armando; Turati, Mauricio; Fabre-Miranda, Karina

    2016-06-01

    The objective of this study is to evaluate the efficacy and safety of a second Ahmed glaucoma valve (AGV) in eyes with refractory glaucoma that had undergone prior Ahmed device implantation. This multicenter, retrospective study evaluated 58 eyes (58 patients) that underwent a second AGV (model S2-n = 50, model FP7-n = 8) due to uncontrolled IOP under maximal medical therapy. Outcome measures included IOP, visual acuity, number of glaucoma medications, and postoperative complications. Success was defined as IOP IOP (criterion 2) with or without hypotensive medications. Persistent hypotony (IOP IOP control were defined as failure. Mean preoperative IOP and mean IOPs at 12 and 30 months were 27.55 ± 1.16 mmHg (n = 58), 14.45 ± 0.83 mmHg (n = 42), and 14.81 ± 0.87 mmHg (n = 16), respectively. The mean numbers of glaucoma medications preoperatively at 12 and 30 months were 3.17 ± 0.16 (n = 58), 1.81 ± 0.2 (n = 42), and 1.83 ± 0.35 (n = 18), respectively. The reductions in mean IOP and number of medications were statistically significant at all time intervals (P IOP in eyes with uncontrolled glaucoma, and is associated with relatively few complications.

  7. Incidence and predictors of vascular access site complications following transfemoral transcatheter aortic valve implantation.

    Science.gov (United States)

    Fonseca, Paulo; Almeida, João; Bettencourt, Nuno; Ferreira, Nuno; Carvalho, Mónica; Ferreira, Wilson; Caeiro, Daniel; Gonçalves, Helena; Ribeiro, José; Rodrigues, Alberto; Braga, Pedro; Gama, Vasco

    2017-10-01

    Vascular access site complications in transfemoral (TF) transcatheter aortic valve implantation (TAVI) are associated with increased morbidity and mortality; however, their incidence and predictors are conflicting between studies. This study sought to assess the incidence and predictors of vascular access site complications in patients undergoing TF TAVI. A total of 140 patients undergoing TF TAVI were included in the study. Minimum iliofemoral diameter and iliofemoral calcium score (CS) were estimated from contrast-enhanced multidetector computed tomography imaging, using different thresholds according to aortic luminal attenuation. To assess the impact of the learning effect, the first 50% of TF TAVI procedures were compared to the remainder. Fifty-one patients presented access site complications (7.1% major, 29.3% minor), most of which were local bleeding or hematoma (11.4%), pseudoaneurysm (7.9%) or closure device failure (5.0%). In a multivariate logistic regression analysis that included sheath-to-iliofemoral artery ratio (SIFAR) (the ratio between the sheath outer diameter and minimum iliofemoral diameter), iliofemoral CS and center experience, SIFAR was the sole independent predictor of access site complications (hazard ratio 14.5, confidence interval [CI] 95% 1.75-120.12, p=0.013). The SIFAR threshold with the highest sum of sensitivity (71.4%) and specificity (53.4%) for access site complications was 0.92 (area under the curve 0.66, 95% CI 0.56-0.75, p=0.002). Vascular access site complications are frequent in patients undergoing TF TAVI. SIFAR was the only independent predictor of access site complications and therefore should be systematically assessed during pre-procedural imaging study. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  8. Local and general anaesthesia do not influence outcome of transfemoral aortic valve implantation.

    Science.gov (United States)

    Dall'Ara, Gianni; Eltchaninoff, Helene; Moat, Neil; Laroche, Cécile; Goicolea, Javier; Ussia, Gian Paolo; Kala, Petr; Wenaweser, Peter; Zembala, Marian; Nickenig, Georg; Snow, Thomas; Price, Susanna; Barrero, Eduardo Alegria; Estevez-Loureiro, Rodrigo; Iung, Bernard; Zamorano, José Luis; Schuler, Gerhard; Alfieri, Ottavio; Prendergast, Bernard; Ludman, Peter; Windecker, Stephan; Sabate, Manel; Gilard, Martine; Witkowski, Adam; Danenberg, Haim; Schroeder, Erwin; Romeo, Francesco; Macaya, Carlos; Derumeaux, Genevieve; Mattesini, Alessio; Tavazzi, Luigi; Di Mario, Carlo

    2014-12-15

    There is great variability for the type of anaesthesia used during TAVI, with no clear consensus coming from comparative studies or guidelines. We sought to detect regional differences in the anaesthetic management of patients undergoing transcatheter aortic valve implantation (TAVI) in Europe and to evaluate the relationship between type of anaesthesia and in-hospital and 1 year outcome. Between January 2011 and May 2012 the Sentinel European TAVI Pilot Registry enrolled 2807 patients treated via a transfemoral approach using either local (LA-group, 1095 patients, 39%) or general anaesthesia (GA-group, 1712 patients, 61%). A wide variation in LA use was evident amongst the 10 participating countries. The use of LA has increased over time (from a mean of 37.5% of procedures in the first year, to 57% in last 6 months, p<0.01). MI, major stroke as well as in-hospital death rate (7.0% LA vs 5.3% GA, p=0.053) had a similar incidence between groups, confirmed in multivariate regression analysis after adjusting for confounders. Dividing our population in tertiles according to the Log-EuroSCORE we found similar mortality under LA, whilst mortality was higher in the highest risk tertile under GA. Survival at 1 year, compared by Kaplan-Meier analysis, was similar between groups (log-rank: p=0.1505). Selection of anaesthesia appears to be more influenced by national practice and operator preference than patient characteristics. In the absence of an observed difference in outcomes for either approach, there is no compelling argument to suggest that operators and centres should change their anaesthetic practice. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  9. Corneal Biomechanical Changes Following Trabeculectomy, Phaco-trabeculectomy, Ahmed Glaucoma Valve Implantation and Phacoemulsification

    Directory of Open Access Journals (Sweden)

    Mohammad Pakravan

    2014-01-01

    Full Text Available Purpose: To determine corneal biomechanical changes following major glaucoma procedures. Methods: In a prospective comparative case series, corneal biomechanical properties were assessed using the Ocular Response Analyzer (ORA, Reichert Inc., Depew, New York, USA before and 3 months after surgery in 89 eyes of 89 patients undergoing trabeculectomy + mitomycin C (MMC (23 eyes, group 1, phacotrabeculectomy + MMC (23 eyes; group 2, Ahmed glaucoma valve (AGV implantation (17 eyes; group 3 or phacoemulsification (PE alone (26 non-glaucomatous eyes; group 4. Patients with history of contact lens use, previous intraocular surgery, any chronic corneal disease, central corneal thickness ≥580 microns or ≤500 microns, post-operative intraocular pressure (IOP > 21 mmHg or ≤ 5 mmHg, and any surgical complication were excluded. Main outcome measures included changes in corneal hysteresis (CH and corneal resistance factor (CRF. Results: Preoperatively, CH was lower in glaucomatous versus non-glaucomatous eyes (5.4, 5.3, 5.2 and 8.1 mmHg in groups 1, 2, 3 and 4 respectively, p<0.001. Three months after surgery, mean CH increased by 2.16, 2.29 and 2.30 mmHg in groups 1, 2 and 3 respectively (P<0.001 but only by 0.11 mmHg in group 4 (p=0.704. The postoperative increase in CH in glaucomatous eyes was more significant when IOP was reduced by more than 10 mmHg. CRF also showed a significant increase in all study groups postoperatively (P<0.001. Conclusion: CH and CRF increased significantly 3 months after glaucoma procedures. Alterations in corneal biomechanical properties should be considered when measuring IOP after successful glaucoma surgery.

  10. Automatic 3D aortic annulus sizing by computed tomography in the planning of transcatheter aortic valve implantation.

    Science.gov (United States)

    Queirós, Sandro; Dubois, Christophe; Morais, Pedro; Adriaenssens, Tom; Fonseca, Jaime C; Vilaça, João L; D'hooge, Jan

    Accurate imaging assessment of aortic annulus (AoA) dimension is paramount to decide on the correct transcatheter heart valve (THV) size for patients undergoing transcatheter aortic valve implantation (TAVI). We evaluated the feasibility and accuracy of a novel automatic framework for multidetector row computed tomography (MDCT)-based TAVI planning. Among 122 consecutive patients undergoing TAVI and retrospectively reviewed for this study, 104 patients with preoperative MDCT of sufficient quality were enrolled and analyzed with the proposed software. Fully automatic (FA) and semi-automatic (SA) AoA measurements were compared to manual measurements, with both automated and manual-based interobserver variability (IOV) being assessed. Finally, the effect of these measures on hypothetically selected THV size was evaluated against the implanted size, as well as with respect to manually-derived sizes. FA analysis was feasible in 92.3% of the cases, increasing to 100% if using the SA approach. Automatically-extracted measurements showed excellent agreement with manually-derived ones, with small biases and narrow limits of agreement, and comparable to the interobserver agreement. The SA approach presented a statistically lower IOV than manual analysis, showing the potential to reduce interobserver sizing disagreements. Moreover, the automated approaches displayed close agreement with the implanted sizes, similar to the ones obtained by the experts. The proposed automatic framework provides an accurate and robust tool for AoA measurements and THV sizing in patients undergoing TAVI. Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  11. FBN1 gene mutation characteristics and clinical features for the prediction of mitral valve disease progression.

    Science.gov (United States)

    Kühne, Kristin; Keyser, Britta; Groene, Eike F; Sheikhzadeh, Sara; Detter, Christian; Lorenzen, Viktoria; Hillebrand, Mathias; Bernhardt, Alexander M J; Hoffmann, Boris; Mir, Thomas S; Robinson, Peter N; Berger, Jürgen; Reichenspurner, Hermann; von Kodolitsch, Yskert; Rybczynski, Meike

    2013-09-30

    Until today, FBN1 gene mutation characteristics were not compared with clinical features for the prediction of mitral valve disease progression. Therefore, we conducted a study of 116 patients (53 men, 63 women aged 33 ± 15 years) with a causative FBN1 gene mutation and ≤ moderate mitral valve regurgitation at baseline. During 7.4 ± 6.8 years 30 patients developed progression of mitral valve regurgitation ≥ 1 grade (primary endpoint), and 26 patients required mitral valve surgery (secondary endpoint). Cox regression analysis identified an association of atrial fibrillation (hazard ratio (HR)=2.703; 95% confidence interval (CI) 1.013-7.211; P=.047), left ventricular ejection fraction (HR=.970; 95%CI .944-.997; P=.032), indexed end-diastolic left ventricular diameter (HR=15.165; 95%CI 4.498-51.128; Pvalve prolapse (HR=2.599; 95%CI 1.243-5.437; P=.011), posterior leaflet prolapse (HR=1.075; 95%CI 1.023-1.130; P=.009), and posterior leaflet thickening (HR=3.368; 95%CI 1.265-8.968; P=.015) with progression of mitral valve disease, whereas none of the FBN1 gene mutation characteristics were associated with progression of mitral valve disease. However, Cox regression analysis identified a marginal relationship of FBN1 gene mutations located both in a transforming-growth-factor beta-binding protein-like (TGFb-BP) domain (HR=3.453; 95%CI .982-12.143; P=.053), and in the calcium-binding epidermal growth factor-like (cbEGF) domain (HR=2.909; 95%CI .957-8.848; P=.060) with mitral valve surgery, a finding that was corroborated by Kaplan-Meier analysis (P=.014; and P=.041, respectively). Clinical features were better predictors of mitral valve disease progression than FBN1 gene mutation characteristics. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  12. Fatores de risco hospitalar para implante de bioprótese valvar de pericárdio bovino Hospital risk factors for bovine pericardial bioprosthesis valve implantation

    Directory of Open Access Journals (Sweden)

    Mateus W. De Bacco

    2007-08-01

    Full Text Available FUNDAMENTO: Identificação de fatores de risco pré-operatórios na cirurgia cardíaca valvar visa melhor resultado cirúrgico pela possível neutralização de condições relacionadas com morbi-mortalidade aumentada. OBJETIVO: Este estudo objetiva identificar fatores de risco hospitalar em pacientes submetidos a implante de bioprótese de pericárdio bovino. MÉTODOS: Estudo retrospectivo incluindo 703 pacientes consecutivos submetidos a implante de pelo menos uma bioprótese de pericárdio bovino St. Jude Medical-Biocor® de setembro de 1991 a dezembro de 2005 no Instituto de Cardiologia do RS, sendo 392 aórticos, 250 mitrais e 61 mitro-aórticos. Analisadas as características sexo, idade, índice de massa corporal, classe funcional (New York Heart Association - NYHA, fração de ejeção, lesão valvar, hipertensão arterial sistêmica, diabete melito, função renal, arritmias cardíacas, cirurgia cardíaca prévia, revascularização miocárdica, plastia tricúspide e caráter eletivo, de urgência ou de emergência da cirurgia. Desfecho primordial foi mortalidade hospitalar. Utilizou-se regressão logística para examinar relação entre fatores de risco e mortalidade hospitalar. RESULTADOS: Ocorreram 101 (14,3% óbitos hospitalares. Características significativamente relacionadas à mortalidade aumentada foram sexo feminino (p 2,4mg/dl (p=0,004, classe funcional IV (pBACKGROUND: Identification of preoperative heart valve surgery risk factors aim to improve surgical outcomes with the possibility to offset conditions related to increased morbidity and mortality. OBJECTIVE: Intent of this study is to identify hospital risk factors in patients undergoing bovine pericardial bioprosthesis implantation. METHODS: Retrospective study including 703 consecutive patients who underwent implantation of at least one St. Jude Medical-Biocor™ bovine pericardial bioprosthesis between September 1991 and December 2005 at the Rio Grande do Sul

  13. [Prediction of the efficiency of endoscopic lung volume reduction by valves in severe emphysema].

    Science.gov (United States)

    Bocquillon, V; Briault, A; Reymond, E; Arbib, F; Jankowski, A; Ferretti, G; Pison, C

    2016-11-01

    In severe emphysema, endoscopic lung volume reduction with valves is an alternative to surgery with less morbidity and mortality. In 2015, selection of patients who will respond to this technique is based on emphysema heterogeneity, a complete fissure visible on the CT-scan and absence of collateral ventilation between lobes. Our case report highlights that individualized prediction is possible. A 58-year-old woman had severe, disabling pulmonary emphysema. A high resolution thoracic computed tomography scan showed that the emphysema was heterogeneous, predominantly in the upper lobes, integrity of the left greater fissure and no collateral ventilation with the left lower lobe. A valve was inserted in the left upper lobe bronchus. At one year, clinical and functional benefits were significant with complete atelectasis of the treated lobe. The success of endoscopic lung volume reduction with a valve can be predicted, an example of personalized medicine. Copyright © 2016 SPLF. Published by Elsevier Masson SAS. All rights reserved.

  14. Comparison of the changes in corneal endothelial cells after pars plana and anterior chamber ahmed valve implant.

    Science.gov (United States)

    Seo, Ji Won; Lee, Jong Yeon; Nam, Dong Heun; Lee, Dae Yeong

    2015-01-01

    Purpose. To compare the changes in corneal endothelial cells after pars plana Ahmed glaucoma valve (AGV) implantation with those after the anterior chamber AGV implantation for refractory glaucoma. Methods. The medical records of 18 eyes with pars plana implantation of AGV (ppAGV) were reviewed retrospectively and were compared with 18 eyes with the anterior chamber AGV (acAGV) implant. The preoperative and postoperative endothelial cells, intraocular pressure (IOP), and postoperative complications during the follow-up in both groups were compared. Results. The average follow-up was 18 months. The postoperative endothelial cells in the ppAGV and acAGV groups were 2044 ± 303 and 1904 ± 324, respectively (P = 0.25). The average percentage decrease in the endothelial cells in the ppAGV and acAGV groups at 18 months was 12.5% and 18.4%, respectively, and showed significant difference between the 2 groups (P = 0.01). No difference in IOP control and the number of postoperative glaucoma medications was observed between the 2 groups. Conclusions. Endothelial cell damage in the ppAGV group for refractory glaucoma appeared to be lower than that in the acAGV group. Therefore, pars plana implantation of AGV may be preferred as it may have lower level of endothelial cell damage while maintaining similar level of IOP control.

  15. Comparison of the Changes in Corneal Endothelial Cells after Pars Plana and Anterior Chamber Ahmed Valve Implant

    Directory of Open Access Journals (Sweden)

    Ji Won Seo

    2015-01-01

    Full Text Available Purpose. To compare the changes in corneal endothelial cells after pars plana Ahmed glaucoma valve (AGV implantation with those after the anterior chamber AGV implantation for refractory glaucoma. Methods. The medical records of 18 eyes with pars plana implantation of AGV (ppAGV were reviewed retrospectively and were compared with 18 eyes with the anterior chamber AGV (acAGV implant. The preoperative and postoperative endothelial cells, intraocular pressure (IOP, and postoperative complications during the follow-up in both groups were compared. Results. The average follow-up was 18 months. The postoperative endothelial cells in the ppAGV and acAGV groups were 2044 ± 303 and 1904 ± 324, respectively (P=0.25. The average percentage decrease in the endothelial cells in the ppAGV and acAGV groups at 18 months was 12.5% and 18.4%, respectively, and showed significant difference between the 2 groups (P=0.01. No difference in IOP control and the number of postoperative glaucoma medications was observed between the 2 groups. Conclusions. Endothelial cell damage in the ppAGV group for refractory glaucoma appeared to be lower than that in the acAGV group. Therefore, pars plana implantation of AGV may be preferred as it may have lower level of endothelial cell damage while maintaining similar level of IOP control.

  16. [The efficacy of Ahmed glaucoma valve implantation in the management of early stage of glaucoma secondary to blunt ocular trauma].

    Science.gov (United States)

    Liu, Xing; Yu, Fen-fen; Zhong, Yi-min; Mao, Zhen; Cao, Dan; Li, Mei

    2012-06-01

    To evaluate the efficacy and safety of Ahmed glaucoma valve (AGV) implantation in the early stage of glaucoma secondary to contusion injuries. A retrospective case series study. The study was made in 29 consecutive patients with glaucoma secondary to blunt trauma who were uncontrolled by multiple medications and then performed AGV implantations in less than 2 months after the trauma. The duration from injury to IOP elevation was 1 to 30 (6.10 ± 1.13) days. The time from injury to AGV implantation was 16 to 60 (40.03 ± 2.97) days. The patients were followed-up for a period of 6 to 42 (20.75 ± 1.66) months. The main outcome measures included intraocular pressure (IOP), visual acuity (VA), number of glaucomatous medications, intra- and postoperative complications. IOPs were analyzed by repeated measures analysis of variance, numbers of medication assessed by Kruskal-Wallis rank sum test followed by Bonferroni test, and VA comparison was performed using paired Student t-test. The absolute success rate was 86.21% and the conditional success rate was 13.79% after AGV implantation. Compared with pre-operation, the IOP was significantly(F = 124.09, P AGV implantation is safe and effective in the management of intractable secondary glaucoma at early stage of contusion injuries.

  17. Temporal trends in transcatheter aortic valve implantation, 2008-2014: patient characteristics, procedural issues, and clinical outcome.

    Science.gov (United States)

    Landes, Uri; Barsheshet, Alon; Finkelstein, Ariel; Guetta, Victor; Assali, Abid; Halkin, Amir; Vaknin-Assa, Hanna; Segev, Amit; Bental, Tamir; Ben-Shoshan, Jeremy; Barbash, Israel M; Kornowski, Ran

    2017-02-01

    About a decade past the first transcatheter aortic valve implantation (TAVI), data are limited regarding temporal trends accompanying its evolution from novel technology to mainstream therapy. We evaluated these trends in a large multicenter TAVI registry. TAVI is changing and improving with time. Patients who underwent TAVI between January 2008 and December 2014 at 3 high-volume Israeli centers were divided into 5 time quintiles according to procedure date. Outcomes were analyzed and reported according to Valve Academic Research Consortium-2. A total of 1285 patients were studied (43% male; mean age, 83 ± 3 years; mean Society of Thoracic Surgeons [STS] score, 5.5 ± 3.6). Over time, there was a shift toward treating patients at lower STS score, increased use of conscious sedation and transfemoral approach, and decreased use of balloon predilatation. The balloon-expandable to self-expandable valve utilization ratio decreased, the valve-in-valve experience increased from 4% to 17% of all TAVI volume, and length of hospital stay was halved (P = 0.006). Kaplan-Meier survival curves showed gradual decrease in mortality risk (P = 0.031), but there was no significant 1-year mortality decrease by multivariable analysis. Each year increment was associated with an adjusted 20%, 15%, and 12% decrease in new pacemaker obligation (P = 0.004), new pacemaker obligation or left bundle branch block (P = 0.008), and in-hospital infections (P = 0.082), respectively. Temporal trends accompanying TAVI evolution include its utilization in lower-risk patients, procedural simplification, improved overall survival, decreased pacemaker obligation, and shorter hospital stay. © 2016 Wiley Periodicals, Inc.

  18. Impact of new-onset persistent left bundle branch block on late clinical outcomes in patients undergoing transcatheter aortic valve implantation with a balloon-expandable valve.

    Science.gov (United States)

    Urena, Marina; Webb, John G; Cheema, Asim; Serra, Vicenç; Toggweiler, Stefan; Barbanti, Marco; Cheung, Anson; Ye, Jian; Dumont, Eric; DeLarochellière, Robert; Doyle, Daniel; Al Lawati, Hatim A; Peterson, Marc; Chisholm, Robert; Igual, Albert; Ribeiro, Henrique Barbosa; Nombela-Franco, Luis; Philippon, François; Garcia Del Blanco, Bruno; Rodés-Cabau, Josep

    2014-02-01

    The aim of this study was to determine the impact of new-onset persistent left bundle branch block (NOP-LBBB) on late outcomes after transcatheter aortic valve implantation (TAVI). The impact of NOP-LBBB after TAVI remains controversial. A total of 668 consecutive patients who underwent TAVI with a balloon-expandable valve without pre-existing LBBB or permanent pacemaker implantation (PPI) were included. Electrocardiograms were obtained at baseline, immediately after the procedure, and daily until hospital discharge. Patients were followed at 1, 6, and 12 months and yearly thereafter. New-onset LBBB occurred in 128 patients (19.2%) immediately after TAVI and persisted at hospital discharge in 79 patients (11.8%). At a median follow-up of 13 months (range 3 to 27 months), there were no differences in mortality rate between the NOP-LBBB and no NOP-LBBB groups (27.8% vs. 28.4%; adjusted-hazard ratio: 0.87 [95% confidence interval (CI): 0.55 to 1.37]; p = 0.54). There were no differences between groups regarding cardiovascular mortality (p = 0.82), sudden death (p = 0.87), rehospitalizations for all causes (p = 0.11), or heart failure (p = 0.55). NOP-LBBB was the only factor associated with an increased rate of PPI during the follow-up period (13.9% vs. 3.0%; hazard ratio: 4.29 [95% CI: 2.03 to 9.07], p < 0.001. NOP-LBBB was also associated with a lack of left ventricular ejection fraction improvement and poorer New York Heart Association functional class at follow-up (p < 0.02 for both). NOP-LBBB occurred in ∼1 of 10 patients who had undergone TAVI with a balloon-expandable valve. NOP-LBBB was associated with a higher rate of PPI, a lack of improvement in left ventricular ejection fraction, and a poorer functional status, but did not increase the risk of global or cardiovascular mortality or rehospitalizations at 1-year follow-up. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. Predicting bioavailability and bioaccumulation of arsenic by freshwater clam Corbicula fluminea using valve daily activity.

    Science.gov (United States)

    Chen, Wei-Yu; Liao, Chung-Min; Jou, Li-John; Jau, Sheng-Feng

    2010-10-01

    There are many bioindicators. However, it remains largely unknown which metal-bioindicator systems will give the reasonable detection ranges of bioavailable metals in the aquatic ecosystem. Various experimental data make the demonstration of biomonitoring processes challenging. Ingested inorganic arsenic is strongly associated with a wide spectrum of adverse health outcomes. Freshwater clam Corbicula fluminea, one of the most commonly used freshwater biomomitoring organisms, presents daily activity in valve movement and demonstrates biotic uptake potential to accumulate arsenic. Here, a systematical way was provided to dynamically link valve daily activity in C. fluminea and arsenic bioavailability and toxicokinetics to predict affinity at arsenic-binding site in gills and arsenic body burden. Using computational ecotoxicology methods, a valve daily rhythm model can be tuned mathematically to the responsive ranges of valve daily activity system in response to varied bioavailable arsenic concentration. The patterned response then can be used to predict the site-specific bioavailable arsenic concentration at the specific measuring time window. This approach can yield predictive data of results from toxicity studies of specific bioindicators that can assist in prediction of risk for aquatic animals and humans.

  20. Surface acoustic wave probe implant for predicting epileptic seizures

    Energy Technology Data Exchange (ETDEWEB)

    Gopalsami, Nachappa [Naperville, IL; Kulikov, Stanislav [Sarov, RU; Osorio, Ivan [Leawood, KS; Raptis, Apostolos C [Downers Grove, IL

    2012-04-24

    A system and method for predicting and avoiding a seizure in a patient. The system and method includes use of an implanted surface acoustic wave probe and coupled RF antenna to monitor temperature of the patient's brain, critical changes in the temperature characteristic of a precursor to the seizure. The system can activate an implanted cooling unit which can avoid or minimize a seizure in the patient.

  1. Prediction of flow in mix-proof valve by use of CFD - Validation by LDA

    DEFF Research Database (Denmark)

    Jensen, Bo Boye Busk; Friis, Alan

    2004-01-01

    of laser beams through the curved surfaces of the valve house changes both intersection angle and intersection location. CFD simulations were performed by use of both the standard wall function and the two-layer model of Norris and Reynolds for near-wall description. The importance of resolving the near...... was done on a spherical shaped mix-proof valve (MPV). Flow were predicted by Computational Fluid Dynamics (CFD) and validated by data obtained from experiments using laser sheet visualization and laser Doppler anemometry. Correction of the measured velocities and probe location was required as refraction...

  2. Comparison of the Ahmed glaucoma valve with the Baerveldt glaucoma implant: a meta-analysis.

    Science.gov (United States)

    Wang, Yi-Wen; Wang, Ping-Bao; Zeng, Chao; Xia, Xiao-Bo

    2015-10-13

    This study aims to compare the efficacy and safety of the Ahmed glaucoma valve (AGV) with the Baerveldt glaucoma implant (BGI) in glaucoma patients. Databases were searched to identify studies that met pre-stated inclusion criteria, involving randomized controlled clinical trials (RCTs) and non-randomized controlled clinical trials. Treatment effect was analyzed using a random-effect model. Ten controlled clinical trials (1048 eyes) were analyzed, involving two RCTs and eight retrospective comparative studies. Short-term results (6-18 months) and long-term results (>18 months) were analyzed separately. There was no significant difference in the success rate for short-term follow-up between the AGV and BGI groups (5 studies, 714 eyes, odds ratio [OR]: 0.97; 95 % confidence interval [CI]: 0.56, 1.66; P = 0.90). For long-term pooled results (7 studies, 835 eyes), the success rate of AGVs was lower than that of BGIs (OR: 0.73; 95 % CI: 0.54, 0.99, P = 0.04), However, subgroup and sensitivity analyses did not show a significant difference in the success rate between the two groups (P ≥0.05). The AGV group had a higher mean intraocular pressure than the BGI group in short-term (6 studies, 685 eyes, weighted mean difference [WMD]: 2.12 mmHg; 95 % CI: 0.72-3.52; P AGV group in two follow-up periods (all P AGV was found to be associated with a significantly lower frequency of total complications (8 studies, 971 eyes, OR: 0.67; 95 % CI: 0.50-0.90; P = 0.007) and severe complications (8 studies, 971 eyes, OR: 0.57; 95 % CI: 0.36-0.91; P = 0.02) than the BGI. The study showed no significant difference in success rate between the two groups. The BGI was more effective for control of intraocular pressure and required fewer medications than the AGV, but the AGV had lower incidence of total and severe complications than the BGI.

  3. Failing left ventricle to ascending aorta conduit-Hybrid implantation of a melody valve and NuMed covered stent.

    Science.gov (United States)

    Gössl, Mario; Johnson, Jonathan N; Hagler, Donald J

    2014-04-01

    We present the case of a 36-year-old woman with increasing shortness of breath, a new 3/4 diastolic murmur, and a complex history of LV outflow tract obstruction. She has undergone multiple surgeries including the replacement of her old LV apex to ascending aorta conduit with a 20-mm Gore-Tex tube graft, addition of a 24-mm homograft sutured between the conduit and the LV apex, and insertion of a 21-mm Freestyle porcine valve conduit between the Gore-Tex tube graft and allograft at age 23. The current assessment showed a failing Freestyle conduit prosthesis leading to left heart decompensation. Due to substantial surgical risk, the patient underwent successful implantation of a Melody valve into the Gore-Tex tube and exclusion of the failing Freestyle bioprosthesis with a NuMed CP stent in a hybrid procedure. The case nicely illustrates the collaborative potential of cardiovascular surgeons and interventional cardiologists in the new arena of a hybrid operating room. Complex hybrid procedures like the current one, especially those including percutaneous placements of valves, offer therapeutic options for patients that are otherwise too high risk for conventional open heart surgery. Copyright © 2013 Wiley Periodicals, Inc.

  4. Early- and mid-term outcomes after transcatheter aortic valve implantation. Data from a single-center registry

    Directory of Open Access Journals (Sweden)

    Maciej Bagienski

    2016-05-01

    Full Text Available Introduction : Transcatheter aortic valve implantation (TAVI is a less invasive treatment option for elderly, high-risk patients with symptomatic severe aortic stenosis (AS than aortic valve replacement. More importantly, TAVI improves survival and quality of life as compared to medical treatment in inoperable patients. Aim: To assess early- and mid-term clinical outcomes after TAVI. Material and methods: All consecutive high-risk patients with severe symptomatic AS undergoing TAVI from November 2008 to August 2014 were enrolled. The clinical and procedural characteristics, as well as clinical outcomes including mortality during 12-month follow-up, were assessed. Results : A total of 101 consecutive patients underwent TAVI for native aortic valve stenosis (100%. Patients were elderly, with a median age of 81.0 (76.0–84.0 years, 60.4% were female and 83.2% presented with NYHA III/IV. Median baseline EuroSCORE I and STS scores were 14.0 (10.0–22.5% and 12.0 (5.0–24.0%, respectively. The main periprocedural and in-hospital complications were minor vascular complications, bleeding requiring blood transfusions, and the need for a permanent pacemaker. In-hospital, 30-day, 6-month and 12-month mortality rates were 6.9%, 10.9%, 15.8% and 17.8%, respectively. Conclusions : A mortality rate of < 20% after 12 months seems acceptable given the high-risk population enrolled.

  5. Is mesocardia with left-sided caval vein draining to coronary sinus a contraindication for a percutaneous pulmonary valve implantation? A case description.

    Science.gov (United States)

    Kantzis, Marinos; Happel, Christoph M; Haas, Nikolaus A

    2017-10-04

    Introduction Although the right jugular vein approach for percutaneous pulmonary valve implantation is well described, there are no reports that describe a percutaneous pulmonary valve implantation through a left superior caval vein to coronary sinus pathway. Case A 14-year-old female with tetralogy of Fallot, mesocardia, left superior caval vein draining into the coronary sinus, and hemiazygos continuation of the inferior caval vein underwent ventricular septal defect closure, with homograft insertion from the right ventricle to the pulmonary artery, patch augmentation of the left pulmonary artery, and creation of an atrial communication. Thereafter followed numerous catheterisations and interventions with stent implantation for stenosis of the left pulmonary artery and the homograft, as did device closure of the atrial communication. When she was a 12-year-old, the indications for a percutaneous pulmonary valve implantation were fulfilled and she underwent implantation of a 22 mm Melody® valve through the left superior caval vein. The extra-stiff exchange wire was pre-formed into a "U-spiral"-type configuration, according to the underlying anatomy, in order to provide a smooth route for the delivery of stents, to create the landing zone, and for the implantation of the Melody "ensemble". The procedure was performed under deep sedation according to our standard protocol. The duration of the procedure was 172 min and the radiation time was 24.9 min. On the basis of this unique experience, percutaneous pulmonary valve implantation is safe and feasible even in patients with unusual anatomy. Crucial is the "U-spiral" shaped configuration of the guide wire.

  6. Comparison of Generalized Estimating Equations and Quadratic Inference Functions in superior versus inferior Ahmed Glaucoma Valve implantation.

    Science.gov (United States)

    Khajeh-Kazemi, Razieh; Golestan, Banafsheh; Mohammad, Kazem; Mahmoudi, Mahmoud; Nedjat, Saharnaz; Pakravan, Mohammad

    2011-03-01

    The celebrated generalized estimating equations (GEE) approach is often used in longitudinal data analysis While this method behaves robustly against misspecification of the working correlation structure, it has some limitations on efficacy of estimators, goodness-of-fit tests and model selection criteria The quadratic inference functions (QIF) is a new statistical methodology that overcomes these limitations. We administered the use of QIF and GEE in comparing the superior and inferior Ahmed glaucoma valve (AGV) implantation, while our focus was on the efficiency of estimation and using model selection criteria, we compared the effect of implant location on intraocular pressure (IOP) in refractory glaucoma patients We modeled the relationship between IOP and implant location, patient's sex and age, best corrected visual acuity, history of cataract surgery, preoperative IOP and months after surgery with assuming unstructured working correlation. 63 eyes of 63 patients were included in this study, 28 eyes in inferior group and 35 eyes in superior group The GEE analysis revealed that preoperative IOP has a significant effect on IOP (p = 0 011) However, QIF showed that preoperative IOP, months after surgery and squared months are significantly associated with IOP after surgery (p < 0 05) Overall, estimates from QIF are more efficient than GEE (RE = 1 272). In the case of unstructured working correlation, the QIF is more efficient than GEE There were no considerable difference between these locations, our results confirmed previously published works which mentioned it is better that glaucoma patients undergo superior AGV implantation.

  7. Comparison of Generalized Estimating Equations and Quadratic Inference Functions in superior versus inferior Ahmed Glaucoma Valve implantation

    Science.gov (United States)

    Khajeh-Kazemi, Razieh; Golestan, Banafsheh; Mohammad, Kazem; Mahmoudi, Mahmoud; Nedjat, Saharnaz; Pakravan, Mohammad

    2011-01-01

    BACKGROUND: The celebrated generalized estimating equations (GEE) approach is often used in longitudinal data analysis While this method behaves robustly against misspecification of the working correlation structure, it has some limitations on efficacy of estimators, goodness-of-fit tests and model selection criteria The quadratic inference functions (QIF) is a new statistical methodology that overcomes these limitations. METHODS: We administered the use of QIF and GEE in comparing the superior and inferior Ahmed glaucoma valve (AGV) implantation, while our focus was on the efficiency of estimation and using model selection criteria, we compared the effect of implant location on intraocular pressure (IOP) in refractory glaucoma patients We modeled the relationship between IOP and implant location, patient's sex and age, best corrected visual acuity, history of cataract surgery, preoperative IOP and months after surgery with assuming unstructured working correlation. RESULTS: 63 eyes of 63 patients were included in this study, 28 eyes in inferior group and 35 eyes in superior group The GEE analysis revealed that preoperative IOP has a significant effect on IOP (p = 0 011) However, QIF showed that preoperative IOP, months after surgery and squared months are significantly associated with IOP after surgery (p AGV implantation. PMID:22091239

  8. Early Ahmed glaucoma valve implantation after penetrating keratoplasty leads to better outcomes in an Asian population with preexisting glaucoma.

    Science.gov (United States)

    Tai, Ming-Cheng; Chen, Yi-Hao; Cheng, Jen-Hao; Liang, Chang-Min; Chen, Jiann-Torng; Chen, Ching-Long; Lu, Da-Wen

    2012-01-01

    To evaluate the efficacy of Ahmed Glaucoma Valve (AGV) surgery and the optimal interval between penetrating keratoplasty (PKP) and AGV implantation in a population of Asian patients with preexisting glaucoma who underwent PKP. In total, 45 eyes of 45 patients were included in this retrospective chart review. The final intraocular pressures (IOPs), graft survival rate, and changes in visual acuity were assessed to evaluate the outcomes of AGV implantations in eyes in which AGV implantation occurred within 1 month of post-PKP IOP elevation (Group 1) and in eyes in which AGV implantation took place more than 1 month after the post-PKP IOP evaluation (Group 2). Factors that were associated with graft failure were analyzed, and the overall patterns of complications were reviewed. By their final follow-up visits, 58% of the patients had been successfully treated for glaucoma. After the operation, there were no statistically significant differences between the groups with respect to graft survival (p = 0.98), but significant differences for IOP control (p = 0.049) and the maintenance of visual acuity (VA) (pAGV failure were a diagnosis of preexisting angle-closure glaucoma, a history of previous PKP, and a preoperative IOP that was >21 mm Hg. The most common surgical complication, aside from graft failure, was hyphema. Early AGV implantation results in a higher probability of AGV survival and a better VA outcome without increasing the risk of corneal graft failure as a result of post-PKP glaucoma drainage tube implantation.

  9. Single-Antiplatelet Therapy in Patients with Contraindication to Dual-Antiplatelet Therapy After Transcatheter Aortic Valve Implantation.

    Science.gov (United States)

    Mangieri, Antonio; Jabbour, Richard J; Montalto, Claudio; Pagnesi, Matteo; Regazzoli, Damiano; Ancona, Marco B; Giannini, Francesco; Tanaka, Akihito; Bertoldi, Letizia; Monaco, Fabrizio; Agricola, Eustachio; Giglio, Manuela; Mattioli, Roberto; Ferri, Luca; Montorfano, Matteo; Chieffo, Alaide; Alfieri, Ottavio; Colombo, Antonio; Latib, Azeem

    2017-04-01

    There is limited evidence to support decision-making regarding discharge antiplatelet therapy after transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the outcome of patients discharged on single-antiplatelet therapy (SAPT) or dual-antiplatelet therapy (DAPT) after TAVI. Consecutive patients were identified by retrospective review of a dedicated TAVI database of a single high-volume center in Milan, Italy, from January 2009 to May 2015. Our primary end point was the rate of net adverse clinical events defined as a composite of all-cause mortality, major bleeding requiring hospitalization, cerebrovascular accidents, redo-TAVI or surgical aortic valve replacement, and valve thrombosis. A total of 439 patients were included in the final analysis; 108 patients were discharged on SAPT and 331 on DAPT. Reasons for discharge SAPT included high risk of bleeding (n = 33; 31%), postprocedural bleeding (n = 42; 39%), thrombocytopenia (n = 20; 18%), vascular complications (n = 13; 12%). The mean length of DAPT was 5.2 ± 2.7 months. Patients discharged in SAPT had a higher incidence of life-threatening bleeding during the index hospitalization. At follow-up, no differences were observed in the incidence of net adverse clinical event, all-cause or cardiovascular mortality, and cerebrovascular events. A similar rate of valve thrombosis was reported in both groups. In conclusion, prescribing only SAPT after TAVI in selected patients was not associated with an increased risk of events and may be an acceptable alternative to DAPT in elderly patients at high risk of bleeding. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Evaluation of the Valve Academic Research Consortium-2 Criteria for Myocardial Infarction in Transcatheter Aortic Valve Implantation: A Prospective Observational Study.

    Directory of Open Access Journals (Sweden)

    Lennart Nilsson

    Full Text Available To evaluate the relevance of the individual components of the Valve Academic Research Consortium (VARC-2 criteria for periprocedural myocardial infarction (MI in transcatheter aortic valve implantation (TAVI. The association between biomarkers and adverse procedural outcome has been established. However, the additive prognostic importance of signs and symptoms are more uncertain.A total of 125 consecutive TAVI patients were prospectively included in this study. Biomarkers for MI were analyzed and signs and symptoms according to VARC-2 criteria were collected from clinical records.The criteria of elevated biomarkers and of signs or symptoms were found in 27 (22% and 32 (26% of the patients, respectively. According to VARC-2 definition, 12 (10% had MI. VARC-2 definition of MI, Troponin T (TnT > 600 ng/L, and presence of signs or symptoms correlated with 6 months mortality, prolonged ICU stay, elevation of N-terminal prohormone brain natriuretic peptide, and renal impairment. No signs or symptoms were found in 7 (44% of the patients who fulfilled the criterion of elevated TnT > 600 ng/L. In the group with positive TnT criterion, there were no significant differences between those with and without signs or symptoms in respect to levels of TnT (1014 [585-1720] ng/L versus 704 [515-905] ng/L, p = 0.17 or creatine kinase-MB (36 [25-52] μg/L versus 29 [25-39] μg/L, p = 0.32. In the multivariate Cox regression analysis, TnT > 600 ng/L was the only significant independent variable associated with 6-months postprocedural mortality.Myocardial injury in TAVI, measured with biomarkers, correlates well with adverse procedural outcome. In this study it is also the strongest predictor for early postprocedural mortality. The additional requirement of signs or symptoms for the diagnosis of MI results in omission of a considerable number of clinically significant MI.

  11. Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial.

    Science.gov (United States)

    Rodés-Cabau, Josep; Masson, Jean-Bernard; Welsh, Robert C; Garcia Del Blanco, Bruno; Pelletier, Marc; Webb, John G; Al-Qoofi, Faisal; Généreux, Philippe; Maluenda, Gabriel; Thoenes, Martin; Paradis, Jean-Michel; Chamandi, Chekrallah; Serra, Vicenç; Dumont, Eric; Côté, Mélanie

    2017-07-10

    The aim of this study was to compare aspirin plus clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve replacement (TAVR) for the prevention of ischemic events, bleeding events, and death. Few data exist on the optimal antithrombotic therapy following TAVR. This was a randomized controlled trial comparing aspirin (80 to 100 mg/day) plus clopidogrel (75 mg/day) (dual antiplatelet therapy [DAPT]) versus aspirin alone (single-antiplatelet therapy [SAPT]) in patients undergoing TAVR with a balloon-expandable valve. The primary endpoint was the occurrence of death, myocardial infarction (MI), stroke or transient ischemic attack, or major or life-threatening bleeding (according to Valve Academic Research Consortium 2 definitions) within the 3 months following the procedure. The trial was prematurely stopped after the inclusion of 74% of the planned study population. A total of 222 patients were included, 111 allocated to DAPT and 111 to SAPT. The composite of death, MI, stroke or transient ischemic attack, or major or life-threatening bleeding tended to occur more frequently in the DAPT group (15.3% vs. 7.2%, p = 0.065). There were no differences between groups in the occurrence of death (DAPT, 6.3%; SAPT, 3.6%; p = 0.37), MI (DAPT, 3.6%; SAT, 0.9%; p = 0.18), or stroke or transient ischemic attack (DAPT, 2.7%; SAPT, 0.9%; p = 0.31) at 3 months. DAPT was associated with a higher rate of major or life-threatening bleeding events (10.8% vs. 3.6% in the SAPT group, p = 0.038). There were no differences between groups in valve hemodynamic status post-TAVR. This small trial showed that SAPT (vs. DAPT) tended to reduce the occurrence of major adverse events following TAVR. SAPT reduced the risk for major or life-threatening events while not increasing the risk for MI or stroke. Larger studies are needed to confirm these results. (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation: The ARTE

  12. Determinants of Left Ventricular Mass Regression in Patients with Severe Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

    Science.gov (United States)

    Weissler-Snir, Adaya; Shapira, Yaron; Sagie, Alexander; Kazum, Shirit; Assali, Abid; Vaknin-Assa, Hana; Bental, Tamir; Codner, Pablo; Orvin, Katia; Kornowski, Ran; Vaturi, Mordehay

    2015-05-01

    The dynamics of left ventricular mass (LVM) regression following the relief of chronic left ventricular pressure overload are prone to variation. The study aim was to identify determinants of LVM regression following transcatheter aortic valve implantation (TAVI). A total of 134 patients undergoing TAVI was identified. A retrospective analysis was performed of LVM indexed to body surface area (LVMi), calculated using transthoracic echocardiography at baseline and at six to 12 months post-TAVI. At six to 12 months after TAVI, there was a significant reduction in mean LVMi (from 118.2 ± 26.67 g/m2 to 103.4 ± 27.07 g/m2; p < 0.001) driven by a decrease in left ventricular wall thickness. The relative wall thickness (RWT) was decreased (0.54 ± 0.10 cm versus 0.51 ± 0.09 cm; p = 0.006), whereas the prevalence of concentric remodeling (RWT ≥ 0.42) remained unchanged (85.1% versus 80.6%; p = 0.3). However, 47 patients (35.1%) demonstrated significant LVMi regression, but had a lower baseline LVMi than patients who demonstrated significant regression (109.8 ± 25.8 g/m2 versus 122 ± 26.1 g/m2; p = 0.008) but had otherwise similar characteristics. A greater magnitude of LVMi reduction was associated with a greater baseline LVMi (r = 0.39; p < 0.001), where patients with LVMi in the highest quartile had the most substantial reduction in LVMi (p < 0.001). Multivariable analysis identified pre-TAVI LVMi as the sole independent predictor of LVMi regression at six to 12 months post-TAVI (P = 0.45; 95% confidence interval 0.255-0.534; p < 0.001). LVM regression at six to months post-TAVI was variable, with about one-third of patients not showing a significant regression. Only baseline LVM predicted LVM regression; patients with a higher baseline LVM demonstrated a greater regression.

  13. Predictors of 1-Year Mortality After Transcatheter Aortic Valve Implantation in Patients With and Without Advanced Chronic Kidney Disease.

    Science.gov (United States)

    Levi, Amos; Codner, Pablo; Masalha, Amer; Gargiulo, Giuseppe; Praz, Fabien; Hayashida, Kentaro; Watanabe, Yusuke; Mylotte, Darren; Debry, Nicolas; Barbanti, Marco; Lefèvre, Thierry; Modine, Thomas; Bosmans, Johan; Windecker, Stephan; Barbash, Israel; Sinning, Jan-Malte; Nickenig, Georg; Barsheshet, Alon; Kornowski, Ran

    2017-12-01

    Advanced chronic kidney disease (CKD) is an independent predictor of mortality in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to identify predictors of 1-year mortality in patients after TAVI stratified by the presence or absence of advanced CKD (defined as estimated glomerular filtration rate ≤30 ml/min/1.73 m2 or permanent renal replacement therapy). Patients (n = 1204) from 10 centers in Europe, Japan, and Israel were included: 464 with and 740 without advanced CKD. Advanced CKD was associated with a 2-fold increase in the adjusted risk of 1-year all-cause death (p <0.001), and a 1.9-fold increase in cardiovascular death (p = 0.016). Interaction-term analysis was used to identify and compare independent predictors of 1-year mortality in both groups. Impaired left ventricular ejection fraction and poor functional class were predictive of death in the advanced CKD group (odds ratio [OR] 2.27, p = 0.002 and OR 3.87, p = 0.003, respectively) but not in patients without advanced CKD (p for interaction = 0.035 and 0.039, respectively), whereas bleeding was a predictor of mortality in the nonadvanced CKD group (OR 3.2, p = 0.005) but not in advanced CKD (p for interaction = 0.006). Atrial fibrillation was associated with a 2.2-fold increase (p = 0.032) in the risk of cardiovascular death in the advanced CKD group but not in the absence of advanced CKD (p for interaction = 0.022). In conclusion, the coexistence of advanced CKD and either reduced left ventricular ejection fraction or poor functional class has an incremental effect on the risk of death after TAVI. In contrast, bleeding had a greater effect on risk of death in patients without advanced CKD. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. The angiotensin II type 1 receptor blocker losartan attenuates bioprosthetic valve leaflet calcification in a rabbit intravascular implant model.

    Science.gov (United States)

    Shin, Hong Ju; Kim, Dae-Hyun; Park, Han Ki; Park, Young Hwan

    2016-12-01

    There is evidence that angiotensin II type I receptor blocker (ARB) could reduce structural valve deterioration. However, the anticalcification effect on the bioprosthetic heart valve (BHV) has not been investigated. Thus, we investigated the effects of losartan (an ARB) on calcification of implanted bovine pericardial tissue in a rabbit intravascular implant model. A total of 16 male New Zealand White rabbits (20 weeks old, 2.98-3.34 kg) were used in this study. Commercially available BHV leaflet of bovine pericardium was trimmed to the shape of a 3-mm triangle and implanted to both external jugular veins of the rabbit. The ARB group (n = 8) was given 25 mg/kg of powdered losartan daily until 6 weeks after surgery by direct administration in the buccal pouch of the animals. The control group (n = 8) was given 5 ml of normal saline by the same method. After 6 weeks, quantitative calcium determination, histological evaluation and western blot analysis of interleukin-6 (IL-6), osteopontin and bone morphogenetic protein 2 (BMP-2) were performed to investigate the mechanisms of the anticalcification effect of losartan. No deaths or complications such as infection or haematoma were recorded during the experiment. All animals were euthanized on the planned date. The calcium measurement level in the ARB group (2.28 ± 0.65 mg/g) was significantly lower than that in the control group (3.68 ± 1.00 mg/g) (P = 0.0092). Immunohistochemistry analyses revealed that BMP-2-positive reactions were significantly attenuated in the ARB group. Western blot analysis showed that losartan suppressed the expression of IL-6, osteopontin and BMP-2. Our results indicate that losartan significantly attenuates postimplant degenerative calcification of a bovine pericardial bioprosthesis in a rabbit intravascular implant model. Further studies are required to assess the effects of ARBs on BHV tissue in orthotopic implantations using a large animal model. © The Author 2016. Published by Oxford

  15. Combined venoarterial extracorporeal membrane oxygenation and transcatheter aortic valve implantation for the treatment of acute aortic prosthesis dysfunction in a high-risk patient.

    Science.gov (United States)

    Pergolini, Amedeo; Zampi, Giordano; Tinti, Maria Denitza; Polizzi, Vincenzo; Pino, Paolo Giuseppe; Pontillo, Daniele; Musumeci, Francesco; Luzi, Giampaolo

    2016-01-01

    We describe the case of a patient with acute bioprosthesis dysfunction in cardiogenic shock, in whom hemodynamic support was provided by venoarterial extracorporeal membrane oxygenation, and successfully treated by transcatheter aortic valve implantation. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. A prospective randomized evaluation of the TriGuard (TM) HDH embolic DEFLECTion device during transcatheter aortic valve implantation : results fromthe DEFLECT III trial

    NARCIS (Netherlands)

    Lansky, Alexandra J.; Schofer, Joachim; Tchetche, Didier; Stella, Pieter; Pietras, Cody G.; Parise, Helen; Abrams, Kevin; Forrest, John K.; Cleman, Michael; Reinoehl, Jochen; Cuisset, Thomas; Blackman, Daniel; Bolotin, Gil; Spitzer, Stefan; Kappert, Utz; Gilard, Martine; Modine, Thomas; Hildick-Smith, David; Haude, Michael; Margolis, Pauliina; Brickman, Adam M.; Voros, Szilard; Baumbach, Andreas

    2015-01-01

    Aims To evaluate the safety, efficacy, and performance of the TriGuard (TM) HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI). Methods and results From February 2014 to March 2015, 85 subjects

  17. Hybrid internal mammary to left anterior descending bypass and transaortic transcatheter aortic valve implantation: a new treatment option for patients with complex disease.

    Science.gov (United States)

    Weich, Hellmuth S vH; van Wyk, Jacques; Pecoraro, Alfonso J; Mabin, Thomas

    2014-09-01

    The case is described of a hybrid trans-aortic transcatheter aortic valve implantation and off-pump left internal mammary artery to left anterior descending artery bypass surgery in a man with a tight left main lesion and severe symptomatic aortic stenosis.

  18. Clinical efficacy analysis of Ahmed glaucoma valve implantation in neovascular glaucoma and influencing factors: A STROBE-compliant article.

    Science.gov (United States)

    He, Ye; Tian, Ying; Song, Weitao; Su, Ting; Jiang, Haibo; Xia, Xiaobo

    2017-10-01

    This study aimed to evaluate the efficacy of Ahmed glaucoma valve (AGV) implantation in treating neovascular glaucoma (NVG) and to analyze the factors influencing the surgical success rate.This is a retrospective review of 40 eyes of 40 NVG patients who underwent AGV implantation at Xiangya Hospital of Central South University, China, between January 2014 and December 2016. Pre- and postoperative intraocular pressure (IOP), visual acuity, surgical success rate, medications, and complications were observed. Surgical success criteria were defined as IOP ≤21 and >6 mm Hg with or without additional medications. Kaplan-Meier survival curves and Multivariate cox regression analysis were used to examine success rates and risk factors for surgical outcomes.The mean follow-up period was 8.88 ± 3.12 months (range: 3-17). IOP declined at each visit postoperatively and it was statistically significant (P AGV implantation is an effective and safe surgical method to treat NVG. Age is an important factor influencing the surgical success rate.

  19. [Ahmed glaucoma valve via pars plana access. Long-term results of implantation for therapy refractive glaucoma].

    Science.gov (United States)

    Mazinani, B; Schwarzer, H; Willkomm, A; Weinberger, A; Plange, N; Walter, P; Rössler, G

    2013-06-01

    Aim of this study is the presentation of long-term results regarding the effectiveness and safety of the implantation of Ahmed glaucoma valve (AGV) devices using a pars plana approach after vitrectomy in the treatment of therapy refractive glaucoma. The implantation of AGV devices using a pars plana approach after vitrectomy was performed in 27 eyes of 22 patients with neovascular glaucoma (n = 7 patients), uveitis (n = 6), complex juvenile secondary glaucoma (n = 4), primary open angle glaucoma (n = 3), pseudoexfoliation glaucoma (n = 1) and nanophthalmus (n = 1). Intraocular pressure, visual acuity and subsequent complications were documented. The mean follow-up period was 23.6 months. Intraocular pressure was significantly reduced from 30.2 mmHg preoperatively to 13 mmHg after a follow-up of 36 months. The mean visual acuity did not change significantly, five eyes required a subsequent explantation of which three were due to AGV-related complications. The implantation of AGV devices using a pars plana approach permits an effective and permanent reduction of intraocular pressure (IOP) even in severe therapy refractive secondary glaucoma; however, the risk of serious sight-threatening complications has to be taken into account.

  20. Incidence, predictors, origin and prevention of early and late neurological events after transcatheter aortic valve implantation (TAVI): a comprehensive review of current data.

    Science.gov (United States)

    Kahlert, Philipp; Al-Rashid, Fadi; Plicht, Björn; Hildebrandt, Heike; Patsalis, Polykarpos; Chilali, Karim El; Wendt, Daniel; Thielmann, Matthias; Bergmann, Lars; Kottenberg, Eva; Schlamann, Marc; Eggebrecht, Holger; Jakob, Heinz; Heusch, Gerd; Konorza, Thomas; Erbel, Raimund

    2013-05-01

    Transcatheter aortic valve implantation (TAVI) is a novel treatment option for patients with severe, symptomatic aortic valve stenosis considered inoperable or at high risk for surgical aortic valve replacement. Despite rapid adoption of this technology into clinical application, however, recent randomized controlled clinical trials have raised safety concerns regarding an increased risk of neurological events with TAVI compared to both medical treatment and conventional, surgical aortic valve replacement. Moreover, neuro-imaging studies have revealed an even higher incidence of new, albeit clinically silent cerebral lesions as a surrogate for procedural embolization. In this article, we review currently available data on the incidence, timing, predictors, prognostic implications and potential mechanisms of neurological events after TAVI.

  1. Echocardiographic findings predict in-hospital and 1-year mortality in left-sided native valve Staphylococcus aureus endocarditis

    DEFF Research Database (Denmark)

    Lauridsen, Trine K.; Park, Lawrence; Tong, Steven Y C

    2015-01-01

    BACKGROUND: Staphylococcus aureus left-sided native valve infective endocarditis (LNVIE) has higher complication and mortality rates compared with endocarditis from other pathogens. Whether echocardiographic variables can predict prognosis in S aureus LNVIE is unknown. METHODS AND RESULTS: Consec...

  2. Recovery from anemia in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation--prevalence, predictors and clinical outcome

    DEFF Research Database (Denmark)

    De Backer, Ole; Arnous, Samer; Lønborg, Jacob

    2014-01-01

    INTRODUCTION: Preoperative anemia is common in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and has been linked to a poorer outcome--including a higher 1-year mortality. The aim of this study was to investigate the impact of successful TAVI...... on baseline anemia. METHODS: A total of 253 patients who survived at least 1 year following TAVI were included in this study. The prevalence, predictors and clinical outcome of hemoglobin (Hb)-recovery were assessed. RESULTS: The prevalence of baseline anemia was 49% (n = 124)--recovery from anemia occurred......-recovery, while blood transfusion (OR 0.31, P = 0.038) and chronic kidney disease (CKD, OR 0.33, P = 0.043) were identified as negative predictors at, respectively, one and two years after TAVI. When compared to patients without baseline anemia, those anemic patients with Hb-recovery had a similar functional...

  3. Short term outcome of Ahmed glaucoma valve implantation in management of refractory glaucoma in a tertiary hospital in Oman

    Science.gov (United States)

    Shah, Manali R.; Khandekar, Rajiv B.; Zutshi, Rajiv; Mahrooqi, Rahima

    2013-01-01

    Background: We present outcomes of Ahmed Glaucoma Valve (AGV) implantation in treating refractory glaucoma in a tertiary hospital in Oman. Refractory glaucoma was defined as previously failed conventional glaucoma surgery and an uncontrolled intraocular pressure (IOP) of more than 21 mm Hg despite treatment with three topical and/or oral therapy. Materials and Methods: This historical cohort study was conducted in 2010. Details of medical and surgical treatment were recorded. Ophthalmologists examined eyes and performed glaucoma surgeries using AGV. The best corrected distant vision, IOP, and glaucoma medications were prospectively reviewed on 1st day, 1st, 6th, 12th week postoperatively, and at the last follow up. Result: Glaucoma specialists examined and treated 40 eyes with refractory glaucoma of 39 patients (20 males + 19 females). Neo-vascular glaucoma was present in 23 eyes. Vision before surgery was AGV surgery. PMID:23772122

  4. Dual source multidetector CT-angiography before transcatheter aortic valve implantation (TAVI) using a high-pitch spiral acquisition mode

    Energy Technology Data Exchange (ETDEWEB)

    Wuest, W.; Anders, K.; May, M.S.; Uder, M. [University of Erlangen, Department of Radiology, Erlangen (Germany); Schuhbaeck, A.; Gauss, S.; Marwan, M.; Arnold, M.; Muschiol, G.; Daniel, W.G.; Achenbach, S. [University of Erlangen, Department of Cardiology, Erlangen (Germany); Ensminger, S. [University of Erlangen, Department of Cardiac Surgery, Erlangen (Germany)

    2012-01-15

    Transcatheter Aortic Valve Implantation (TAVI) is an alternative to surgical valve replacement in high risk patients. Angiography of the aortic root, aorta and iliac arteries is required to select suitable candidates, but contrast agents can be harmful due to impaired renal function. We evaluated ECG-triggered high-pitch spiral dual source Computed Tomography (CT) with minimized volume of contrast agent to assess aortic root anatomy and vascular access. 42 patients (82 {+-} 6 years) scheduled for TAVI underwent dual source (DS) CT angiography (CTA) of the aorta using a prospectively ECG-triggered high-pitch spiral mode (pitch = 3.4) with 40 mL iodinated contrast agent. We analyzed aortic root/iliac dimensions, attenuation, contrast to noise ratio (CNR), image noise and radiation exposure. Aortic root/iliac dimensions and distance of coronary ostia from the annulus could be determined in all cases. Mean aortic and iliac artery attenuation was 320 {+-} 70 HU and 340 {+-} 77 HU. Aortic/iliac CNR was 21.7 {+-} 6.8 HU and 14.5 {+-} 5.4 HU using 100 kV (18.8 {+-} 4.1 HU and 8.7 {+-} 2.6 HU using 120 kV). Mean effective dose was 4.5 {+-} 1.2 mSv. High-pitch spiral DSCTA can be used to assess the entire aorta and iliac arteries in TAVI candidates with a low volume of contrast agent while preserving diagnostic image quality. (orig.)

  5. POL-TAVI - Polish Registry of Transcatheter Aortic Valve Implantation - simple tool, great value, rationale and design.

    Science.gov (United States)

    Zembala-John, Joanna; Wilczek, Krzysztof; Tobota, Zdzisław; Chodór, Piotr; Cieśla, Daniel; Jaźwiec, Tomasz; Banasiak, Waldemar; Stępińska, Janina; Kalarus, Zbigniew; Opolski, Grzegorz; Zembala, Marian

    2016-12-01

    Aortic stenosis (AS) is the most common valvular heart disease in adults in Europe and North America. Management of AS patients depends on accurate diagnosis of the cause and stage of the disease process: the first and definitive therapeutic choice for a growing number of elderly patients with symptomatic AS is surgical treatment. In patients not eligible for surgery, transcatheter aortic valve implantation (TAVI) constitutes a safe and effective alternative. As an innovative, costly method of treatment, it requires however careful monitoring of its course, documenting its early and long-term results, and assessment of its safety and medical-economic cost-effectiveness. A medical registry seems to be an excellent tool to perform such analysis. The aim of this paper is to present the design and rationale for creation of the first National Cardiac-Cardiac Surgical Registry of Percutaneous Aortic Valve Treatment POL-TAVI, to describe its genesis and to highlight its key assumptions and aims. Despite its recent beginnings, the POL-TAVI Registry has already demonstrated its value and usability in monitoring and assessment of TAVI procedures, leading to further improvement and development of this new method in Poland. It constitutes an important and valuable tool for patients, the medical community and the payer.

  6. The 2011-2012 pilot European Society of Cardiology Sentinel Registry of Transcatheter Aortic Valve Implantation: 12-month clinical outcomes.

    Science.gov (United States)

    Gilard, Martine; Schlüter, Michael; Snow, Thomas M; Dall'Ara, Gianni; Eltchaninoff, Helene; Moat, Neil; Goicolea, Javier; Ussia, Gian Paolo; Kala, Petr; Wenaweser, Peter; Zembala, Marian; Nickenig, Georg; Price, Susanna; Alegria Barrero, Eduardo; Iung, Bernard; Zamorano, Pepe; Schuler, Gerhard; Corti, Roberto; Alfieri, Ottavio; Prendergast, Bernard; Ludman, Peter; Windecker, Stephan; Sabate, Manel; Witkowski, Adam; Danenberg, Haim; Schroeder, Erwin; Romeo, Francesco; Macaya, Carlos; Derumeaux, Geneviève; Laroche, Cécile; Pighi, Michele; Serdoz, Roberta; Di Mario, Carlo

    2016-05-17

    Our aim was to assess one-year outcomes of patients enrolled in the pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation (TAVI). One-year outcomes of 4,571 patients (81.4±7.2 years, 2,291 [50.1%] male) receiving TAVI with the SAPIEN XT (57.3%) or CoreValve prosthesis at 137 European centres were analysed using Kaplan-Meier and Cox proportional hazards regression techniques. At one year, 3,341 patients were alive, 821 had died, and 409 were lost to follow-up. Of 2,125 patients who underwent functional assessment, 1,916 (90%) were in New York Heart Association (NYHA) Class I/II at one year, with functional improvement from baseline noted in 1,682 patients (88%). One-year survival based on 4,564 patients was estimated at 79.1%. Independent baseline predictors of mortality were increasing age and logistic EuroSCORE, the presence of NYHA III/IV, chronic obstructive pulmonary disease, and atrial fibrillation. Female gender was associated with a 4% survival benefit at one year. Vascular access routes other than transfemoral were associated with poorer survival. Procedural failure and major periprocedural complications had an adverse impact on survival. Contemporary European experience attests to the effectiveness of routine TAVI in unselected elderly patients.

  7. POL-TAVI – Polish Registry of Transcatheter Aortic Valve Implantation – simple tool, great value, rationale and design

    Science.gov (United States)

    Wilczek, Krzysztof; Tobota, Zdzisław; Chodór, Piotr; Cieśla, Daniel; Jaźwiec, Tomasz; Banasiak, Waldemar; Stępińska, Janina; Kalarus, Zbigniew; Opolski, Grzegorz; Zembala, Marian

    2016-01-01

    Aortic stenosis (AS) is the most common valvular heart disease in adults in Europe and North America. Management of AS patients depends on accurate diagnosis of the cause and stage of the disease process: the first and definitive therapeutic choice for a growing number of elderly patients with symptomatic AS is surgical treatment. In patients not eligible for surgery, transcatheter aortic valve implantation (TAVI) constitutes a safe and effective alternative. As an innovative, costly method of treatment, it requires however careful monitoring of its course, documenting its early and long-term results, and assessment of its safety and medical-economic cost-effectiveness. A medical registry seems to be an excellent tool to perform such analysis. The aim of this paper is to present the design and rationale for creation of the first National Cardiac-Cardiac Surgical Registry of Percutaneous Aortic Valve Treatment POL-TAVI, to describe its genesis and to highlight its key assumptions and aims. Despite its recent beginnings, the POL-TAVI Registry has already demonstrated its value and usability in monitoring and assessment of TAVI procedures, leading to further improvement and development of this new method in Poland. It constitutes an important and valuable tool for patients, the medical community and the payer. PMID:28096826

  8. Feasibility of hybrid off pump artery bypass grafting and transaortic transcatheter aortic valve implantation: A case series.

    Science.gov (United States)

    Manoly, Imthiaz; Hasan, Ragheb; Brazier, Andrew; Farooq, Vasim; Thompson, Thomas; Karunaratne, Devinda; Naylor, Heather; Fraser, Douglas

    2017-06-01

    Patients with complex coronary artery disease and severe aortic stenosis unsuitable for conventional cardiac surgery pose a significant treatment challenge. This is especially difficult for patients where percutaneous revascularization is technically very challenging and/or would not offer as complete revascularisation compared to surgical revascularisation. In addition, patients who are unsuitable for transfemoral transcatheter aortic valve implantation (TAVI) pose an additional technical challenge, particularly with dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI). As a potential solution we describe the first case series of hybrid off-pump coronary artery bypass grafting (CABG) combined with transaortic TAVI. Over a ten-month-period, four patients underwent hybrid off-pump CABG combined with transaortic TAVI. A full sternotomy allowed off-pump arterial and vein graft anastomosis to significantly stenosed coronaries. The first three patients had severe aorto-iliac disease precluding femoral access; the fourth patient was deemed unsuitable for PCI. Transaortic TAVI using Edwards Sapien 3 valves were performed without complication in all four patients. The hybrid off-pump CABG and transaortic TAVI procedure allows for more complete coronary revascularization, negates the need for DAPT, and minimizes treatment delay of a TAVI procedure, particularly in patients unsuitable for transfemoral access. We propose this as an important treatment option for the heart team to consider. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  9. Comparison of Generalized Estimating Equations and Quadratic Inference Functions in superior versus inferior Ahmed Glaucoma Valve implantation

    Directory of Open Access Journals (Sweden)

    Razieh Khajeh-Kazemi

    2011-01-01

    Full Text Available Background: The celebrated generalized estimating equations (GEE approach is often used in longitudinal data analysis While this method behaves robustly against misspecification of the working correlation structure, it has some limitations on efficacy of estimators, goodness-of-fit tests and model selection criteria The quadratic inference functions (QIF is a new statistical methodology that overcomes these limitations Methods : We administered the use of QIF and GEE in comparing the superior and inferior Ahmed glaucoma valve (AGV implantation, while our focus was on the efficiency of estimation and using model selection criteria, we compared the effect of implant location on intraocular pressure (IOP in refractory glaucoma patients We modeled the relationship between IOP and implant location, patient′s sex and age, best corrected visual acuity, history of cataract surgery, preoperative IOP and months after surgery with assuming unstructured working correlation Results : 63 eyes of 63 patients were included in this study, 28 eyes in inferior group and 35 eyes in superior group The GEE analysis revealed that preoperative IOP has a significant effect on IOP (p = 0 011 However, QIF showed that preoperative IOP, months after surgery and squared months are significantly associated with IOP after surgery (p < 0 05 Overall, estimates from QIF are more efficient than GEE (RE = 1 272 Conclusions : In the case of unstructured working correlation, the QIF is more efficient than GEE There were no considerable difference between these locations, our results confirmed previously published works which mentioned it is better that glaucoma patients undergo superior AGV implantation

  10. The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland.

    Science.gov (United States)

    Parma, Radosław; Dąbrowski, Maciej; Ochała, Andrzej; Witkowski, Adam; Dudek, Dariusz; Siudak, Zbigniew; Legutko, Jacek

    2017-01-01

    Few studies have assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008, and data on current TAVI activity or practice are missing. To assess the dynamics of TAVI adoption in Poland and to detect differences among Polish centres in TAVI practice and decision-making. The Polish Interventional Cardiology TAVI Survey (PICTS) was approved by the Polish Association of Cardiovascular Interventions and presented to all 21 national TAVI centres. Between 2008 and 2015 the cumulative number of TAVI performed in Poland was 2189. The annual number of TAVI rose from 8 in 2008 to 670 in 2015 (0.21 to 17.4 implants per million inhabitants, respectively). The median TAVI experience per centre was 80 procedures (95% CI: 38.1-154.6). In 2015 the TAVI penetration rate reached 5.12% of the estimated eligible Polish population. Inoperable and high-risk patients are treated with TAVI in all centres, with 52% of Heart Teams also qualifying medium-risk patients. The rate of transfemoral implantations increased to 83.2% of all procedures in 2015, while transapical implantations decreased to 12%. The frequency of subclavian, direct aortic or transcarotid routes in 2015 was below 3% each. The PICTS survey observed a positive but slow rate of adoption of TAVI in Poland. When compared to Western European countries, our findings highlight a significant treatment gap in high or prohibitive surgical risk patients with severe aortic stenosis. Remarkable variations in TAVI practices among Polish TAVI centres warrant publication of joint national guidelines and recommendations.

  11. Long-Term Outcome of Intravitreal Bevacizumab Followed by Ahmed Valve Implantation in the Management of Neovascular Glaucoma.

    Science.gov (United States)

    Tailor, Rajen; Kinsella, Matt T; Clarke, Jonathan C

    2017-10-09

    To report the outcome of intravitreal Bevacizumab followed by Ahmed valve implantation in the management of neovascular glaucoma in a patient group with extended follow-up. The records of 16 patients (18 eyes) with neovascular glaucoma refractory to medical therapy who presented to a single surgeon between 2006-2008 were reviewed. Patients received pan-retinal photocoagulation and then intravitreal Bevacizumab followed by Ahmed valve implantation. The main outcome measures were: control of IOP (with or without additional medication), visual acuity (VA) and failure (IOP >21 mmHg or AGV. The mean pre-operative IOP was 37.1 mmHg (±13.4) on 3.2 (±0.87) medications. Of the 18 eyes, 14 eyes (78%) were treated with AGV alone and 4 eyes (22%) with AGV combined with cataract extraction. Sixteen eyes (89%) received mitomycin C treatment intraoperatively. Post-operatively, the mean follow-up period was 63 months (24-84). At final follow-up, the success rate was 50% (33.3% complete, 16.7% qualified) with a mean IOP of 18.1 mmHg (±9.5) on a mean number of 1.5 (±1.6) medications. The failure rate was 50%, with five eyes (27.8%) not meeting the IOP criteria for success (of these, three eyes required additional surgery to lower the IOP) and five eyes (22.2%) lost light perception. Intravitreal Bevacizumab followed by AGV offers long-term control of IOP without additional surgical intervention in the majority of cases.

  12. Implante transapical de valva aórtica: resultados de uma nova prótese brasileira Transapical aortic valve implantation: results of a brazilian prosthesis

    Directory of Open Access Journals (Sweden)

    Diego Felipe Gaia

    2010-09-01

    procedimento alternativo.OBJECTIVE: The aortic valve replacement is a routine procedure with acceptable risk, but in some cases, such a risk can justify contraindication. The minimally invasive transcatheter aortic valve implantation has been viable, with lower morbidity and mortality. The aim of this study was to develop a national catheter-mounted aortic bioprosthesis for the aortic position implant. METHODS: After animal studies, 14 patients with high EuroSCORE underwent transcatheter aortic valve implantation. Median Logistic EuroSCORE was 43.7%. Four patients presented with dysfunctional bioprosthesis, remaining ones presented calcified aortic stenosis. All patients presented symptoms. Procedures were performed in a hybrid OR under fluoroscopic and echocardiography guidance. Using a left minithoracotomy the prosthesis was implanted through the ventricular apex under ventricular pacing or hemorrhagic shock, after aortic valvoplasty. Echocardiograph and angiograph controls were performed, and the patients were referred to ICU. RESULTS: Implant was feasible in 13 cases. There were no intra-operative deaths. Median peak transvalvular aortic gradient reduced to 25.0 mmHg, and left ventricular function improved in the first seven post-operative days. Paravalvular aortic regurgitation was mild and present in 71%. No definitive pacemaker was needed. There was no peripheral vascular complication. Overall mortality was 42%. CONCLUSION: The transapical implantation of cathetermounted bioprosthesis was a feasible procedure. Long term follow-up is mandatory in order to access efficacy and indications.

  13. Prevalence and Prediction of Obstructive Coronary Artery Disease in Patients Undergoing Primary Heart Valve Surgery.

    Science.gov (United States)

    Cazelli, José Guilherme; Camargo, Gabriel Cordeiro; Kruczan, Dany David; Weksler, Clara; Felipe, Alexandre Rouge; Gottlieb, Ilan

    2017-10-01

    The prevalence of coronary artery disease (CAD) in valvular patients is similar to that of the general population, with the usual association with traditional risk factors. Nevertheless, the search for obstructive CAD is more aggressive in the preoperative period of patients with valvular heart disease, resulting in the indication of invasive coronary angiography (ICA) to almost all adult patients, because it is believed that coronary artery bypass surgery should be associated with valve replacement. To evaluate the prevalence of obstructive CAD and factors associated with it in adult candidates for primary heart valve surgery between 2001 and 2014 at the National Institute of Cardiology (INC) and, thus, derive and validate a predictive obstructive CAD score. Cross-sectional study evaluating 2898 patients with indication for heart surgery of any etiology. Of those, 712 patients, who had valvular heart disease and underwent ICA in the 12 months prior to surgery, were included. The P value arterial hypertension, diabetes mellitus, dyslipidemia, smoking, and male gender. The model showed excellent correlation and calibration (R² = 0.98), as well as excellent accuracy (ROC of 0.848; 95%CI: 0.817-0.879) and validation (ROC of 0.877; 95%CI: 0.830 - 0.923) in different valve populations. Obstructive CAD can be estimated from clinical data of adult candidates for valve repair surgery, using a simple, accurate and validated score, easy to apply in clinical practice, which may contribute to changes in the preoperative strategy of acquired heart valve surgery in patients with a lower probability of obstructive disease.

  14. Prediction of oxygen distribution in aortic valve leaflet considering diffusion and convection.

    Science.gov (United States)

    Wang, Ling; Korossis, Sotirios; Fisher, John; Ingham, Eileen; Jin, Zhongmin

    2011-07-01

    Oxygen supply and transport is an important consideration in the development of tissue engineered constructs. Previous studies from our group have focused on the effect of tissue thickness on the oxygen diffusion within a three-dimensional aortic valve leaflet model, and highlighted the necessity for additional transport mechanisms such as oxygen convection. The aims of this study were to investigate the effect of interstitial fluid flow within the aortic valve leaflet, induced by the cyclic loading of the leaflet, on oxygen transport. Indentation testing and finite element modelings were employed to derive the biphasic properties of the leaflet tissue. The biphasic properties were subsequently used in the computational modeling of oxygen convection in the leaflet, which was based on the effective interstitial fluid velocity and the tissue deformation. Subsequently, the oxygen profile was predicted within the valve leaflet model by solving the diffusion and convection equation simultaneously utilizing the finite difference method. The compression modulus (E) and hydraulic permeability were determined by adapting a finite element model to the experimental indentation test on valvular tissue, E = 0.05MPa, and k =2.0 mm4/Ns. Finite element model of oxygen convection in valvular tissue incorporating the predicted biphasic properties was developed and the interstitial fluid flow rate was calculated falling in range of 0.025-0.25 mm/s depending on the tissue depth. Oxygen distribution within valvular tissue was predicted using one-dimensional oxygen diffusion model taking into consider the interstitial fluid effect. It was found that convection did enhance the oxygen transport in valvular tissue by up to 68% increase in the minimum oxygen tension within the tissue, depending on the strain level of the tissue as reaction of the magnitude and frequencies of the cardiac loading. The effective interstitial fluid velocity was found to play an important role in enhancing the

  15. Computational Models for Predicting Outcomes of Neuroprosthesis Implantation: the Case of Cochlear Implants.

    Science.gov (United States)

    Ceresa, Mario; Mangado, Nerea; Andrews, Russell J; Gonzalez Ballester, Miguel A

    2015-10-01

    Electrical stimulation of the brain has resulted in the most successful neuroprosthetic techniques to date: deep brain stimulation (DBS) and cochlear implants (CI). In both cases, there is a lack of pre-operative measures to predict the outcomes after implantation. We argue that highly detailed computational models that are specifically tailored for a patient can provide useful information to improve the precision of the nervous system electrode interface. We apply our framework to the case of CI, showing how we can predict nerve response for patients with both intact and degenerated nerve fibers. Then, using the predicted response, we calculate a metric for the usefulness of the stimulation protocol and use this information to rerun the simulations with better parameters.

  16. Towards real-time cardiovascular magnetic resonance-guided transarterial aortic valve implantation: In vitro evaluation and modification of existing devices

    Directory of Open Access Journals (Sweden)

    Ladd Mark E

    2010-10-01

    Full Text Available Abstract Background Cardiovascular magnetic resonance (CMR is considered an attractive alternative for guiding transarterial aortic valve implantation (TAVI featuring unlimited scan plane orientation and unsurpassed soft-tissue contrast with simultaneous device visualization. We sought to evaluate the CMR characteristics of both currently commercially available transcatheter heart valves (Edwards SAPIEN™, Medtronic CoreValve® including their dedicated delivery devices and of a custom-built, CMR-compatible delivery device for the Medtronic CoreValve® prosthesis as an initial step towards real-time CMR-guided TAVI. Methods The devices were systematically examined in phantom models on a 1.5-Tesla scanner using high-resolution T1-weighted 3D FLASH, real-time TrueFISP and flow-sensitive phase-contrast sequences. Images were analyzed for device visualization quality, device-related susceptibility artifacts, and radiofrequency signal shielding. Results CMR revealed major susceptibility artifacts for the two commercial delivery devices caused by considerable metal braiding and precluding in vivo application. The stainless steel-based Edwards SAPIEN™ prosthesis was also regarded not suitable for CMR-guided TAVI due to susceptibility artifacts exceeding the valve's dimensions and hindering an exact placement. In contrast, the nitinol-based Medtronic CoreValve® prosthesis was excellently visualized with delineation even of small details and, thus, regarded suitable for CMR-guided TAVI, particularly since reengineering of its delivery device toward CMR-compatibility resulted in artifact elimination and excellent visualization during catheter movement and valve deployment on real-time TrueFISP imaging. Reliable flow measurements could be performed for both stent-valves after deployment using phase-contrast sequences. Conclusions The present study shows that the Medtronic CoreValve® prosthesis is potentially suited for real-time CMR-guided placement

  17. Favorable Clinical Outcomes of Transcatheter Aortic Valve Implantation in Japanese Patients - First Report From the Post-Approval K-TAVI Registry.

    Science.gov (United States)

    Takimoto, Shinya; Saito, Naritatsu; Minakata, Kenji; Shirai, Shinichi; Isotani, Akihiro; Arai, Yoshio; Hanyu, Michiya; Komiya, Tatsuhiko; Shimamoto, Takeshi; Goto, Tsuyoshi; Fuku, Yasushi; Ehara, Natsuhiko; Furukawa, Yutaka; Koyama, Tadaaki; Nagasawa, Atsuhi; Tamura, Toshihiro; Miyake, Makoto; Yamanaka, Kazuo; Sakaguchi, Hisashi; Murata, Koichiro; Onodera, Tomoya; Yamazaki, Fumio; Nakai, Masanao; Taniguchi, Tomohiko; Sakata, Ryuzo; Kimura, Takeshi

    2016-12-22

    Very limited data exist on the outcomes of transcatheter aortic valve implantation (TAVI) since Japanese marketing approval of the first TAVI device.Methods and Results:The Kyoto University-related hospital Transcatheter Aortic Valve Implantation (K-TAVI) registry includes prospectively collected data from 6 participating hospitals in Japan. We included 302 patients with severe aortic stenosis who underwent TAVI using the SAPIEN XT balloon-expandable valve via transfemoral (TF; n=203, 67%) or transapical (TA; n=99, 33%) approach between October 2013 and September 2015. Device success rate, based on the Valve Academic Research Consortium-2 criteria, was very high in the TF (97.0%) and TA (99.0%) groups. The 30-day mortality rates were 1.5% and 1.0% in the TF and TA groups, respectively. Major complications included stroke (transient or persistent: 2.3%), annulus rupture (1.0%), coronary intervention (1.0%), major vascular complications (1.7%), and permanent pacemaker implantation (5.4%). The procedure times of the post-proctoring period (n=210) were decreased compared with those of the proctoring period (n=89) without affecting the clinical outcomes. The survival rates at 6 and 12 months were 96.9% and 92.5% in the TF group, and 93.9% and 91.8% in the TA group, respectively. The K-TAVI registry data revealed that the early outcomes of TAVI using the SAPIEN XT were favorable in real-world Japanese patients.

  18. Stent pour implantation percutanée d'une valve cardiaque

    OpenAIRE

    Marchand, Coralie

    2009-01-01

    The goal of this work is to develop an atraumatic stent concept for percutaneous aortic valve replacement. Shape setted braided nitinol wires, thanks to their specific geometry and elasticity, allows stent's compressibility, self deployment and aortic root preservation. Prototypes manufacturing technique and relatives constraints are presented. Performance of the obtained prototypes are evaluated in vitro, in terms of sealing, static and dynamic regurgitation. More specifically, the pulsatile...

  19. Long-Term Outcomes for Patients With Severe Symptomatic Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation.

    Science.gov (United States)

    Codner, Pablo; Orvin, Katia; Assali, Abid; Sharony, Ram; Vaknin-Assa, Hanna; Shapira, Yaron; Schwartzenberg, Shmuel; Bental, Tamir; Sagie, Alexander; Kornowski, Ran

    2015-11-01

    Transcatheter aortic valve implantation (TAVI) is an established technique for the treatment of severe symptomatic aortic stenosis. Data on long-term TAVI outcomes, both hemodynamic and clinical, in real-world practice settings are limited. We aim to explore the long-term clinical results in patients with severe symptomatic aortic stenosis using multiple catheter-based options: 360 TAVI-treated patients were followed up for ≤5 years. The Medtronic CoreValve was used in 71% and the Edwards SAPIEN in 26%. The primary end point was all-cause mortality during follow-up. Outcomes were assessed based on the Valve Academic Research Consortium 2 criteria. The mean ± SD patient age was 82.1 ± 6.9 years (56.4% women). The Society of Thoracic Surgeons score was 7.5 ± 4.7. The clinical efficacy end point and time-related valve safety at 3 years was 50% and 81.7%, respectively. The calculated 3- and 5-year survival rates were 71.6% and 56.4%, respectively. Five-year follow-up data were obtained for 54 patients alive; 96.2% of alive patients were in the New York Heart Association class I and II, 4 years after TAVI. No gender differences in all-cause mortality rates were observed (p = 0.58). In multivariate analysis, hospitalization 6 months previous to TAVI (hazard ratio [HR] 1.92, 95% confidence interval [CI] 1.17 to 3.15, p = 0.01), frailty (HR 1.89, 95% CI 1.11 to 3.2, p = 0.02), acute kidney injury (HR 1.93, 95% CI 1.03 to 3.61, p = 0.04), and moderate or more paravalvular aortic regurgitation after TAVI (HR 4.26, 95% CI 2.54 to 7.15, p <0.001) were independent predictors for all-cause mortality. In conclusion, long-term outcomes of TAVI are encouraging. Prevention and early identification of paravalvular leak and acute renal failure after the procedure would improve short- and long-term outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

  20. Implante transcateter de valva aórtica: resultados atuais do desenvolvimento e implante de um nova prótese brasileira Transcatheter aortic valve implantation: results of the current development and implantation of a new Brazilian prosthesis

    Directory of Open Access Journals (Sweden)

    Diego Felipe Gaia

    2011-09-01

    Full Text Available OBJETIVO: A troca valvar aórtica é procedimento rotineiro com risco aceitável. Em alguns casos, a mortalidade é elevada, contraindicando o procedimento. O implante minimamente invasivo transcateter de valva aórtica parece ser alternativa, reduzindo a morbimortalidade. A avaliação dos resultados clínicos, segurança e eficácia do procedimento são o objetivo desse estudo. MÉTODOS: Uma prótese transcateter, balão expansível foi utilizada em 33 casos de alto risco. EuroScore médio foi de 39,30% e STS score de 30,28%. Oito pacientes apresentavam disfunção de bioprótese e o restante, estenose aórtica calcificada. Os procedimentos foram realizados em ambiente cirúrgico híbrido, sob controle ecocardiográfico e fluoroscópico. Através de minitoracotomia esquerda, as próteses foram implantadas pelo ápice ventricular, sob estimulação de alta frequência ou choque hemorrágico. Foram realizados controles clínicos e ecocardiográficos. RESULTADOS: A correta liberação da prótese foi possível em 30 casos. Três conversões ocorreram. A mortalidade operatória foi de um caso e a mortalidade em 30 dias, 18,18%. O gradiente médio reduziu de 43,58 para 10,54 mmHg. A fração de ejeção apresentou aumento significativo após o 7º pós-operatório. Insuficiência aórtica residual esteve presente em 30,30% dos pacientes. Ocorreu uma complicação vascular periférica e um caso de bloqueio atrioventricular total. Um paciente apresentou acidente vascular cerebral. A mortalidade em 30 dias foi de 18,18%. CONCLUSÃO: O implante transapical de valva aórtica transcateter é procedimento seguro e com resultados de médio prazo satisfatórios. São necessários estudos de longo prazo com maior poder amostral no intuito de determinar resultado hemodinâmico, qualidade de vida e sobrevida em longo prazoOBJECTIVE: Aortic valve replacement is a routine procedure with acceptable risk, but in some cases, such risk can justify contraindication

  1. Tackling the Issue of High Postoperative Pacemaker Implantation Rates in Sutureless Aortic Valve Replacement: Should Balloon Inflation be Removed from the Implantation Method of the Perceval Prosthesis?

    Science.gov (United States)

    Charles Blouin, Mathieu; Bouhout, Ismail; Demers, Philippe; Carrier, Michel; Perrault, Louis; Lamarche, Yoan; El-Hamamsy, Ismail; Bouchard, Denis

    2017-05-01

    Sutureless aortic valve replacement (AVR) is an emerging alternative to standard AVR in elderly and high-risk patients. This procedure is associated with a high rate of postoperative permanent pacemaker implantation (PPI). The study aim was to assess the impact on the rate of PPI of implanting the Perceval prosthesis without using balloon inflation. A total of 159 patients who underwent sutureless AVR using the Perceval prosthesis was included. Balloon inflation was used in 132 patients (Balloon group) and not used in the remaining 27 (No-Balloon group). Clinical, echocardiographic and electrocardiographic outcomes were assessed. There was no significant difference in PPI rate between the two groups (26% for Balloon group versus 22% in No-Balloon group; p = 0.700). Balloon inflation had no significant impact on the incidence of paravalvular leaks (p = 0.839), or on the need to return to cardiopulmonary bypass (CPB) intraoperatively due to paravalvular leak or unsatisfactory deployment (p >0.999). Mean and peak transaortic pressure gradients were similar between the two groups (p = 0.417 and p = 0.522, respectively). Cross-clamp and CPB times were shorter in the No-Balloon group (49.6 ± 15.9 min versus 61.1 ± 25.6 min and 64.1 ± 26.3 min versus 79.6 ± 35.4 min, respectively; p = 0.027 and p = 0.012, respectively). The two groups had similar postoperative PPI rates. Implanting the Perceval prosthesis without balloon inflation is safe and had no impact on paravalvular leaks, intraoperative complications or hemodynamic results. Reductions in aortic cross-clamp time and CPB time were observed when the balloon was not used.

  2. Incidence, outcome and correlates of residual paravalvular aortic regurgitation after transcatheter aortic valve implantation and importance of haemodynamic assessment.

    Science.gov (United States)

    Patsalis, Polykarpos C; Konorza, Thomas F M; Al-Rashid, Fadi; Plicht, Björn; Riebisch, Matthias; Wendt, Daniel; Thielmann, Matthias; Jakob, Heinz; Eggebrecht, Holger; Heusch, Gerd; Erbel, Raimund; Kahlert, Philipp

    2013-04-22

    Residual paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is common. We therefore evaluated incidence, determinants and outcome of PAR after TAVI. Data from 167 consecutive transcatheter TAVI patients were analysed. PAR was graded by angiography and the pressure gradient between diastolic aortic pressure and left ventricular end-diastolic pressure (∆PDAP-LVEDP) after implantation. TAVI was technically successful in all patients. Mortality was 9% and 20% at 30 days and one year, respectively. Post-procedural PAR was absent in 54 patients (32.3%). Mild PAR was found in 89 (53.3%), moderate in 21 (12.6%), and moderate-to-severe in three patients (1.8%). Cardiovascular mortality at 30 days and one year was increased in patients with moderate and moderate-to-severe PAR compared to patients with no and mild PAR (46% vs. 4% and 73% vs. 7%, respectively, p<0.001). Receiver operating characteristic curve analysis suggested ∆PDAP-LVEDP ≤18 mmHg as a novel predictor of mortality, with an area under the curve of 0.97. In patients undergoing TAVI, moderate and moderate-to-severe PAR was observed in 14.4% and associated with increased cardiovascular mortality. A pressure gradient ∆PDAP-LVEDP≤18 mmHg carries adverse prognosis and requires further intervention.

  3. Transfemoral aortic valve implantation is more successful with the Edwards Sapien 3 compared with the Edwards XT for the treatment of symptomatic severe aortic stenosis.

    Science.gov (United States)

    Gonska, Birgid; Seeger, Julia; Junker, Alexander; Rodewald, Christoph; Trepte, Ulrike; Scharnbeck, Dominik; Rottbauer, Wolfgang; Wöhrle, Jochen

    2017-11-08

    Residual aortic regurgitation (AR) after transfemoral aortic valve implantation (TAVI) is associated with increased mortality. The new Edwards Sapien 3 valve (ES3) is designed to reduce paravalvular AR. To compare a new-generation and a late-generation balloon-expandable transcatheter heart valve. In this study, 100 consecutive patients treated with the ES3 for symptomatic native severe aortic stenosis were compared with 100 consecutive patients treated with the Edwards Sapien XT valve (EXT); all valves were implanted via transfemoral access. We compared residual AR, rate of permanent pacemaker implantation, device success according to the second Valve Academic Research Consortium (VARC-2) criteria and 30-day follow-up. With the ES3, the risk of moderate/severe AR was lower (0% vs 3%), the risk of mild AR was lower (31% vs 40%) and the final result with no AR was higher (P=0.07). The mean aortic gradient was significantly higher with the ES3 (12.2±4.6 vs 9.4±3.9mmHg; P<0.01). Device success according to the VARC-2 criteria was high with the ES3 and the EXT (97% vs 95%; P=0.48). Pacemaker implantation because of higher-grade atrioventricular block was similar: 9.3% after ES3 implantation and 6.9% after EXT implantation (P=0.56). There was significantly less major or life-threatening bleeding with the ES3: 5% vs 14% (P=0.03) and 0% vs 8% (P<0.01), respectively. After 30 days, the VARC-2 early-safety endpoint was significantly lower with the ES3 (P<0.01). In conclusion, TAVI with the ES3 in patients with symptomatic severe aortic stenosis was associated with no moderate/severe AR, a trend towards a lower rate of mild AR, a significantly lower rate of major or life-threatening bleeding and early safety according to VARC-2 criteria within 30 days compared with the EXT. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  4. Long-term Outcomes of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma at Farabi Eye Hospital, Tehran, Iran.

    Science.gov (United States)

    Zarei, Reza; Amini, Heidar; Daneshvar, Ramin; Nabi, Fahimeh Naderi; Moghimi, Sasan; Fakhraee, Ghasem; Eslami, Yadollah; Mohammadi, Masoud; Amini, Nima

    2016-01-01

    To describe long-term outcomes and complications of Ahmed glaucoma valve (AGV) implantation in subjects with refractory glaucoma at Farabi Eye Hospital, Tehran, Iran. This retrospective cohort study evaluated patient records of all subjects with refractory glaucoma who had undergone AGV implantation up to January 2013. The main outcome measure was the surgical success rate. Complete success was defined as intraocular pressure (IOP) <22 mmHg, without anti-glaucoma medications or additional surgery. Qualified success was IOP <22 mmHg regardless of number of anti-glaucoma medications. In all cases, loss of vision (no light perception) was considered an independent indicator of failure. Data were also collected on intraoperative and postoperative complications. Twenty-eight eyes were included in the study. With a mean follow-up of 48.2 ± 31.7 months (median: 40.50 months; range: 3-124 months), the IOP decreased from a mean preoperative value of 30.8 ± 5.6 mmHg to 20.0 ± 6.4 mmHg at last visit. The number of medications decreased from 3.7 ± 0.4 preoperatively to 2.5 ± 1.1 postoperatively. Cumulative qualified success was achieved in 69% of eyes. Mean time to failure according to qualified success criteria was 92.3 ± 9.4 months. Postoperative complications were recorded in 16 (57.1%) eyes. The most common complication was focal endothelial corneal decompensation at the site of tube-cornea touch. AGV implantation with adjunctive topical anti-glaucoma drops controlled IOP in approximately 70% of eyes with refractory glaucoma with a median of 40.5 months of follow-up. However, complication rates were higher.

  5. Capacity Fast Prediction and Residual Useful Life Estimation of Valve Regulated Lead Acid Battery

    Directory of Open Access Journals (Sweden)

    Qin He

    2017-01-01

    Full Text Available The usable capacity of acid lead batteries is often used as the degradation feature for online RUL (residual useful life estimation. In engineering applications, the “standard” fully discharging method for capacity measure is quite time-consuming and harmful for the high-capacity batteries. In this paper, a data-driven framework providing capacity fast prediction and RUL estimation for high-capacity VRLA (valve regulated lead acid batteries is presented. These batteries are used as backup power sources on the ships. The relationship between fully discharging time and partially discharging voltage curve is established for usable capacity extrapolation. Based on the predicted capacity, the particle filtering approach is utilized to obtain battery RUL distribution. A case study is conducted with the experimental data of GFM-200 battery. Results confirm that our method not only reduces the prediction time greatly but also performs quite well in prediction accuracy of battery capacity and RUL.

  6. 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.

  7. Predictive value of platelet-to-lymphocyte ratio in severe degenerative aortic valve stenosis

    Directory of Open Access Journals (Sweden)

    Efe Edem

    2016-01-01

    Full Text Available Background: Aortic valve stenosis (AVS is the most common cause of left ventricular outflow obstruction, and its prevalence among elderly patients causes a major public health burden. Recently, platelet-to-lymphocyte ratio (PLR has been recognized as a novel prognostic biomarker that offers information about both aggregation and inflammation pathways. Since PLR indicates inflammation, we hypothesized that PLR may be associated with the severity of AVS due to chronic inflammation pathways that cause stiffness and calcification of the aortic valve. Materials and Methods: We retrospectively enrolled 117 patients with severe degenerative AVS, who underwent aortic valve replacement and 117 control patients in our clinic. PLR was defined as the absolute platelet count divided by the absolute lymphocyte count. Severe AVS was defined as calcification and sclerosis of the valve with a mean pressure gradient of >40 mmHg. Results: PLR was 197.03 ± 49.61 in the AVS group and 144.9 ± 40.35 in the control group, which indicated a statistically significant difference (P < 0.001. A receiver operating characteristic (ROC curve analysis demonstrated that PLR values over 188 predicted the severity of aortic stenosis with a sensitivity of 87% and a specificity of 70% (95% confidence interval = 0.734–0.882; P < 0.001; area under ROC curve: 0.808. Conclusion: We suggest that the level of PLR elevation is related to the severity of degenerative AVS, and PLR should be used to monitor patients' inflammatory responses and the efficacy of treatment, which will lead us to more closely monitor this high-risk population to detect severe degenerative AVS at an early stage.

  8. Clopidogrel, aspirin and proton pump inhibition after percutaneous valve implants: an update.

    Science.gov (United States)

    Fusari, Melissa

    2013-01-01

    This paper reviews literary evidence on antithrombotic therapies currently employed in TAVR to assess validity and efficacy; duration and modality are also considered. In the absence of firm guidelines and reliable trial results, we analyze current knowledge of interaction between PPI and antithrombotic drugs. TAVR has been associated with Double Antiplatelet Therapy since 2002. This was an empirical approach for a new stentmounted tissue valve to prevent early and late MACCE that affect survival and quality of life. Systematic searches of major bibliographic databases, contact with experts in the field, and review of primary articles, review papers, and guidelines has been performed. We analyze TAVR features and pitfalls in existing trials to understand which therapy would fit patients better and we confront these with established clinical practice guidelines of the population treated for cardiovascular disease. TAVR is a new technology that compresses a tissue valve onto an expandable stent. Technical and procedural issues have been solved, but strokes and major bleeding still affect patients' life despite double antiplatelet therapy given to reduce MACCE. To balance pros and cons, antithrombotic therapy with Warfarin or new anticoagulants can be used in patients with previous AF or NOAF to prevent stroke; while single antiplatelet with PPI is a better alternative in patients with liver disease, gastric ulcer or drug abuse to avoid bleeding events. While waiting for randomized trials, a tailored therapy based upon physician's experience and close patient follow-up is the safest, most effective treatment.

  9. Mitral valve implantation using off-pump closed beating intracardiac surgery: a feasibility study.

    Science.gov (United States)

    Guiraudon, Gerard M; Jones, Douglas L; Bainbridge, Daniel; Peters, Terry M

    2007-10-01

    We have developed the Universal Cardiac Introducer (UCI) with the aim of modernizing the off-pump, closed, beating, intracardiac approach. This paper reports our ongoing experience with positioning of a prosthetic MV, under image-guidance, substituting for direct vision. The UCI is comprised of two detachable parts: an attachment-cuff and an airlock-introductory chamber for bulky tools. A prosthetic MV was introduced into the left atrium in 12 pigs via the UCI (LA appendage). Transesophageal and 4D epicardial ultrasound were used for guidance. Limitations of ultrasound imaging prompted the development of a multimodality virtual reality (VR) system introduced in the last three animals. There were no complications associated with cardiac access, while achieving proper valve positioning. TEE contributed to navigating, while 4D epicardial ultrasound was adequate for positioning the prosthesis into the MV orifice. VR provided a 3D context for real-time US imaging with precise navigation and positioning using augmented reality representation of the valve. We demonstrated the feasibility of positioning MV prostheses via the UCI. These results suggest the tremendous potential of virtual reality in making access safe and effective for many intracardiac targets, with the ultimate goal of a safe, versatile, clinical application.

  10. T Cell Response in Patients with Implanted Biological and Mechanical Prosthetic Heart Valves.

    Science.gov (United States)

    Barbarash, L; Kudryavtsev, I; Rutkovskaya, N; Golovkin, A

    2016-01-01

    The study was aimed at assessing T cell subsets of peripheral blood from recipients of long-term functioning (more than 60 months) biological and mechanical heart valve prostheses. The absolute and relative number of CD4 and CD8 T cell subsets was analyzed: naïve (N, CD45RA(+)CD62L(+)), central memory (CM, CD45RA(-)CD62L(+)), effector memory (EM, CD45RA(-)CD62L(-)), and terminally differentiated CD45RA-positive effector memory (TEMRA, CD45RA(+)CD62L(-)) in 25 persons with biological and 7 with mechanical prosthesis compared with 48 apparently healthy volunteers. The relative and absolute number of central memory and naïve CD3(+)CD8(+) in patients with biological prosthesis was decreased (p mechanical prosthesis had increased absolute and relative number of CD45RA(+)CD62L(-)CD3(+)CD8(+) cells (p = 0.006). Also the relative number of CD3(+)CD4(+) cells was reduced (p = 0.04). We assume that altered composition of T cell subsets points at development of xenograft rejection reaction against both mechanical and biological heart valve prostheses.

  11. T Cell Response in Patients with Implanted Biological and Mechanical Prosthetic Heart Valves

    Directory of Open Access Journals (Sweden)

    L. Barbarash

    2016-01-01

    Full Text Available The study was aimed at assessing T cell subsets of peripheral blood from recipients of long-term functioning (more than 60 months biological and mechanical heart valve prostheses. The absolute and relative number of CD4 and CD8 T cell subsets was analyzed: naïve (N, CD45RA+CD62L+, central memory (CM, CD45RA−CD62L+, effector memory (EM, CD45RA−CD62L−, and terminally differentiated CD45RA-positive effector memory (TEMRA, CD45RA+CD62L− in 25 persons with biological and 7 with mechanical prosthesis compared with 48 apparently healthy volunteers. The relative and absolute number of central memory and naïve CD3+CD8+ in patients with biological prosthesis was decreased (p<0.001. Meanwhile the number of CD45RA+CD62L−CD3+CD8+ and CD3+CD4+ was increased (p<0.001. Patients with mechanical prosthesis had increased absolute and relative number of CD45RA+CD62L−CD3+CD8+ cells (p=0.006. Also the relative number of CD3+CD4+ cells was reduced (p=0.04. We assume that altered composition of T cell subsets points at development of xenograft rejection reaction against both mechanical and biological heart valve prostheses.

  12. Incidence, Prognostic Impact, and Predictive Factors of Readmission for Heart Failure After Transcatheter Aortic Valve Replacement.

    Science.gov (United States)

    Durand, Eric; Doutriaux, Maxime; Bettinger, Nicolas; Tron, Christophe; Fauvel, Charles; Bauer, Fabrice; Dacher, Jean-Nicolas; Bouhzam, Najime; Litzler, Pierre-Yves; Cribier, Alain; Eltchaninoff, Hélène

    2017-12-11

    The aim of this study was to assess the incidence, prognostic impact, and predictive factors of readmission for congestive heart failure (CHF) in patients with severe aortic stenosis treated by transcatheter aortic valve replacement (TAVR). TAVR is indicated in patients with severe symptomatic aortic stenosis in whom surgery is considered high risk or is contraindicated. Readmission for CHF after TAVR remains a challenge, and data on prognostic and predictive factors are lacking. All patients who underwent TAVR from January 2010 to December 2014 were included. Follow-up was achieved for at least 1 year and included clinical and echocardiographic data. Readmission for CHF was analyzed retrospectively. This study included 546 patients, 534 (97.8%) of whom were implanted with balloon-expandable valves preferentially via the transfemoral approach in 87.8% of cases. After 1 year, 285 patients (52.2%) had been readmitted at least once, 132 (24.1%) for CHF. Patients readmitted for CHF had an increased risk for death (p < 0.0001) and cardiac death (p < 0.0001) compared with those not readmitted for CHF. On multivariate analysis, aortic mean gradient (hazard ratio [HR]: 0.88; 95% confidence interval [CI]: 0.79 to 0.99; p = 0.03), post-procedural blood transfusion (HR: 2.27; 95% CI: 1.13 to 5.56; p = 0.009), severe post-procedural pulmonary hypertension (HR: 1.04; 95% CI: 1.00 to 1.07; p < 0.0001), and left atrial diameter (HR: 1.47; 95% CI: 1.08 to 2.01; p = 0.02) were independently associated with CHF readmission at 1 year. Readmission for CHF after TAVR was frequent and was strongly associated with 1-year mortality. Low gradient, persistent pulmonary hypertension, left atrial dilatation, and transfusions were predictive of readmission for CHF. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  13. Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves

    DEFF Research Database (Denmark)

    Dvir, Danny; Webb, John; Brecker, Stephen

    2012-01-01

    Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry....

  14. Risk Prediction in Aortic Valve Replacement: Incremental Value of the Preoperative Echocardiogram.

    Science.gov (United States)

    Tan, Timothy C; Flynn, Aidan W; Chen-Tournoux, Annabel; Rudski, Lawrence G; Mehrotra, Praveen; Nunes, Maria C; Rincon, Luis M; Shahian, David M; Picard, Michael H; Afilalo, Jonathan

    2015-10-26

    Risk prediction is a critical step in patient selection for aortic valve replacement (AVR), yet existing risk scores incorporate very few echocardiographic parameters. We sought to evaluate the incremental predictive value of a complete echocardiogram to identify high-risk surgical candidates before AVR. A cohort of patients with severe aortic stenosis undergoing surgical AVR with or without coronary bypass was assembled at 2 tertiary centers. Preoperative echocardiograms were reviewed by independent observers to quantify chamber size/function and valve function. Patient databases were queried to extract clinical data. The cohort consisted of 432 patients with a mean age of 73.5 years and 38.7% females. Multivariable logistic regression revealed 3 echocardiographic predictors of in-hospital mortality or major morbidity: E/e' ratio reflective of elevated left ventricular (LV) filling pressure; myocardial performance index reflective of right ventricular (RV) dysfunction; and small LV end-diastolic cavity size. Addition of these echocardiographic parameters to the STS risk score led to an integrated discrimination improvement of 4.1% (Pvalue to the STS risk score and should be integrated in prediction when evaluating the risk of AVR. In addition, findings of small hypertrophied LV cavities and/or low mean aortic gradients confer a higher risk of 2-year mortality. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  15. Prediction model for penile prosthesis implantation for erectile dysfunction management.

    Science.gov (United States)

    Segal, Robert L; Camper, Stephen B; Ma, Larry; Burnett, Arthur L

    2014-10-01

    Penile prosthesis surgery is indicated based on undesirability, contraindication or ineffectiveness of non-surgical options for erectile dysfunction. This definitive treatment is often delayed after initial diagnosis. Our objective was to develop a prediction tool based on a patient's clinical history to determine likelihood of ultimately receiving a penile prosthesis. This retrospective analysis used claims data from Commercial and Medicare supplemental databases. Inclusion criteria were 18 years of age with 1 year of continuous enrollment at the first diagnosis of erectile dysfunction. Patients' demographics, co-morbidities and erectile dysfunction therapy were derived based on enrollment, medical and prescription histories. The Cox proportional hazards model with stepwise selection was used to identify and quantify (using relative risk) factors associated with a future penile prosthesis implant. Co-morbidities and therapies present prior to the index erectile dysfunction diagnosis were analyzed as fixed covariates. Approximately 1% of the dataset's population (N = 310,303 Commercial, N = 74,315 Medicare, respectively) underwent penile prosthesis implantation during the study period (3928 patients in the overall population: 2405 patients [0.78%] in the Commercial and 1523 patients [2.05%] in the Medicare population). Factors with the greatest predictive strength of penile prosthesis implantation included prostate cancer diagnosis (relative risk: 3.93, 2.29; 95% CI, 3.57-4.34, 2.03-2.6), diabetes mellitus (2.31, 1.23; 2.12-2.52, 1.1-1.37) and previous treatment with first-line therapy (1.39, 1.33; 1.28-1.5, 1.2-1.47) (all P prosthesis. Calculating the likelihood of penile prosthesis implantation based on the weight of these factors may assist clinicians with the definition of a care plan and patient counseling. The precision of the model may be limited by factors beyond medical history information that possibly influence the decision to proceed to

  16. Long-term results of non-valved Glaucoma drainage implant surgery and glaucoma drainage implant combined with trabeculectomy

    Directory of Open Access Journals (Sweden)

    Teruhiko Hamanaka

    2014-01-01

    Full Text Available Purpose: The purpose was to investigate the efficacy and complications of nonvalved glaucoma drainage implant (GDI surgery and GDI combined with trabeculectomy. Subjects and Methods: Serial Japanese patients who received GDI were retrospectively investigated. The survival rate of eyes was analyzed using the Kaplan-Meier method, defining death as: (1 Intraocular pressure (IOP <6 mmHg, or ≥22 mmHg, and <20% reduction of preoperative IOP, (2 additional glaucoma surgery, (3 loss of light perception. Prognostic factors of age, sex, previous surgery, type of glaucoma, synechial closure, preoperative IOP, type of GDI (single-, double-plate Molteno, Baerveldt 350 and GDI combined with trabeculectomy were investigated employing proportional hazards analysis. Results: One hundred and twenty-four eyes of 109 patients aged 53.3 ± 7.8 years old were analyzed. Types of GDI were single-plate (15.3%, double-plate Molteno (71.8%, and Baerveldt 350 (12.9%. The results of survival rate analysis were 86.1, 71.1, 71.1, and 64.6% for 1, 3, 5, and 10 years respectively. Thirty-four eyes (27.4% died because of uncontrolled IOP (19.4%, loss of light perception (5.6%, and additional glaucoma surgery (2.4%. Single-plate Molteno was the only risk factor for failure. Persistent unphysiological hypotony (0.8% and bullous keratopathy (5.6% were observed. Conclusion: Nonvalved GDI surgery and GDI combined with trabeculectomy using nonabsorbable tube ligature proved to be an excellent device for any type of glaucoma in Japanese patients. Hypotony and corneal endothelial loss are the most serious complication in the long-term results of our patients.

  17. GuaragnaSCORE satisfactorily predicts outcomes in heart valve surgery in a Brazilian hospital.

    Science.gov (United States)

    Sá, Michel Pompeu Barros de Oliveira; Sá, Marcus Villander Barros de Oliveira; Albuquerque, Ana Carla Lopes de; Silva, Belisa Barreto Gomes da; Siqueira, José Williams Muniz de; Brito, Phabllo Rodrigo Santos de; Vasconcelos, Frederico Pires; Lima, Ricardo de Carvalho

    2012-01-01

    The aim of this study is to evaluate the applicability of GuaragnaSCORE for predicting mortality in patients undergoing heart valve surgery in the Division of Cardiovascular Surgery of Pronto Socorro Cardiológico de Pernambuco - PROCAPE, Recife, PE, Brazil. Retrospective study involving 491 consecutive patients operated between May/2007 and December/2010. The registers contained all the information used to calculate the score. The outcome of interest was death. Association of model factors with death (univariate analysis and multivariate logistic regression analysis), association of risk score classes with death and accuracy of the model by the area under the ROC (receiver operating characteristic) curve were calculated. The incidence of death was 15.1%. The nine variables of the score were predictive of perioperative death in both univariate and multivariate analysis. We observed that the higher the risk class of the patient (low, medium, high, very high, extremely high), the greater is the incidence of postoperative AF (0%; 7.2%; 25.5%; 38.5%; 52.4%), showing that the model seems to be a good predictor of risk of postoperative death, in a statistically significant association (P <0.001). The score presented a good accuracy, since the discrimination power of the model in this study according to the ROC curve was 78.1%. The Brazilian score proved to be a simple and objective index, revealing a satisfactory predictor of perioperative mortality in patients undergoing heart valve surgery at our institution.

  18. Evaluation of aortic regurgitation after transcatheter aortic valve implantation: aortic root angiography in comparison to cardiac magnetic resonance.

    Science.gov (United States)

    Frick, Michael; Meyer, Christian G; Kirschfink, Annemarie; Altiok, Ertunc; Lehrke, Michael; Brehmer, Kathrin; Lotfi, Shahram; Hoffmann, Rainer

    2016-03-01

    Aortic regurgitation (AR) is common after transcatheter aortic valve implantation (TAVI). Intraprocedural assessment of AR relies on aortic root angiography. Cardiac magnetic resonance (CMR) phase-contrast mapping of the ascending aorta provides accurate AR quantification. This study evaluated the accuracy of AR grading by aortic root angiography after TAVI in comparison to CMR phase-contrast velocity mapping. In 69 patients with TAVI for severe aortic stenosis, post-procedural AR was determined by aortic root angiography with visual assessment according to the Sellers classification and by CMR using phase-contrast velocity mapping for analysis of AR volume and fraction. Spearman's correlation coefficient showed a moderate correlation between angiographic analysis of AR grade and CMR-derived AR volume (r=0.41; pangiography with cut-off Sellers grade ≥2 had a sensitivity of 71% and a specificity of 98% to detect AR graded as moderate to severe or severe as defined by CMR. There is only a moderate correlation between aortic root angiography and CMR in the classification of AR severity after TAVI. Alternative imaging including multimodality imaging as well as haemodynamic analysis should therefore be considered for intraprocedural AR assessment and guidance of TAVI procedure in cases of uncertainty in AR grading.

  19. Acute Reverse Remodelling After Transcatheter Aortic Valve Implantation: A Link Between Myocardial Fibrosis and Left Ventricular Mass Regression.

    Science.gov (United States)

    Dobson, Laura Elizabeth; Musa, Tarique A; Uddin, Akhlaque; Fairbairn, Timothy A; Swoboda, Peter P; Erhayiem, Bara; Foley, James; Garg, Pankaj; Haaf, Philip; Fent, Graham J; Malkin, Christopher J; Blackman, Daniel J; Plein, Sven; Greenwood, John P

    2016-12-01

    Despite the wealth of data showing the positive effects on cardiac reverse remodelling in the long-term, the immediate effects of transcatheter aortic valve implantation (TAVI) on the left ventricle are yet to be comprehensively described using cardiovascular magnetic resonance imaging. Also, the link between myocardial fibrosis and acute left ventricular (LV) mass regression is unknown. Fifty-seven patients with severe aortic stenosis awaiting TAVI underwent paired cardiovascular magnetic resonance scans before and early after the procedure (4 [interquartile range, 3-5] days). LV mass, volume, and function were measured. Late gadolinium enhancement (LGE) imaging was performed to assess for the presence of and pattern of myocardial fibrosis. After the procedure, 53 (95%) patients experienced an immediate (10.1 ± 7.1%) reduction in indexed LV mass (LVMi) from 76 ± 15.5 to 68.4 ± 14.7 g/m(2) (P reverse remodelling occurs immediately after TAVI, with significant LV mass regression in the total population and an improvement in LVEF in those with preexisting LV impairment. Those without myocardial fibrosis at baseline experience greater LV mass regression than those with fibrosis. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  20. Reservations about the Selvester QRS score in left bundle branch block - Experience in patients with transcatheter aortic valve implantation.

    Science.gov (United States)

    Poels, Thomas T; Kats, Suzanne; Veenstra, Leo; van Ommen, Vincent; Maessen, Jos G; Prinzen, Frits W

    The Selvester QRS score (S-score) estimates myocardial scar using electrocardiographic criteria. We evaluated the S-score for left bundle branch block (LBBB). Studied were 36 patients who developed persistent LBBB upon transcatheter aortic valve implantation (TAVI, TAVI-LBBB group) and 36 matched patients with persistent narrow QRS (TAVI-nQRS group). Electrocardiograms were recorded before and briefly after TAVI and during ~6months follow-up. S-score was calculated using criteria for hypertrophic (in absence of LBBB) or LBBB hearts. In TAVI-LBBB patients correlation between S-scores pre-TAVI and post-TAVI was absent (R 2 =0.023). High S-scores post-TAVI occurred in patients with low pre-TAVI scores. Pre-post TAVI scores correlated weakly in TAVI-nQRS (R 2 =0.182), indicating a possible influence of ventricular unloading by TAVI. In both groups S-scores at post-TAVI and follow-up compared reasonably (R 2 =0.389 and R 2 =0.386), indicating reproducibility in more stable conditions. This study indicates that the use of the LBBB S-score criteria overestimates scar size and that caution is recommended in the use of the score in patients with LBBB. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  1. The Impact of Transcatheter Aortic Valve Implantation on Mitral Regurgitation Regression in High-Risk Patients with Aortic Stenosis.

    Science.gov (United States)

    Perl, Leor; Vaturi, Mordehay; Assali, Abid; Sagie, Alexander; Weissler-Snir, Adaya; Codner, Pablo; Orvin, Katia; Vaknin-Assa, Hana; Shapira, Yaron; Kornowski, Ran

    2015-07-01

    In patients with aortic stenosis, mitral regurgitation (MR) is a common finding. Little is known regarding outcomes of MR in patients undergoing transcatheter aortic valve implantation (TAVI). The study aim was to characterize the short- and mid-term impact of the TAVI procedure on MR grade. A total of 261 patients (59% females; mean age 82.1 +/- 6.9 years) undergoing TAVI was assessed for rates of significant MR and the severity of MR at baseline, and at one month and six months after the procedure. In patients with moderate MR or above at baseline (n = 26, 10% of the cohort), there was a mean reduction in grade of 1.5 +/- 1.1 and 1.8 +/- 1.4 after one and six months, respectively (p < 0.01). Reduction in MR grade (1+) at six months was identified in 54.1% (40/74) of patients with mild-moderate MR or greater, and in 88.5% (23/26) of those with moderate MR or above, and was associated with an improved NYHA functional class (correlation coefficient r = -0.294, p < 0.001). Multivariate analysis identified low pulmonary pressure and tricuspid regurgitation as independent predictors of improvements in MR. Among the present cohort of patients undergoing TAVI, those with MR at baseline showed an improvement in the severity of their MR. Patients with moderate MR regurgitation or above demonstrated the greatest improvement.

  2. Heart-rate adjustment of transcatheter haemodynamics improves the prognostic evaluation of paravalvular regurgitation after transcatheter aortic valve implantation.

    Science.gov (United States)

    Jilaihawi, Hasan; Chakravarty, Tarun; Shiota, Takahiro; Rafique, Asim; Harada, Kenji; Shibayama, Kentaro; Doctor, Niraj; Kashif, Mohammad; Nakamura, Mamoo; Mirocha, James; Rami, Tejas; Okuyama, Kazuaki; Cheng, Wen; Sadruddin, Omar; Siegel, Robert; Makkar, Raj R

    2015-08-01

    Paravalvular aortic regurgitation (PVAR) after balloon-expandable transcatheter aortic valve implantation (TAVI) remains difficult to quantify, and the utility of the AR index (ARi) to create a composite aortic insufficiency (CAI) score was an important advance. Heart rate (HR) influences the ARi but the clinical relevance of this phenomenon remains poorly appreciated. We sought to validate a new composite heart-rate-adjusted haemodynamic-echocardiographic aortic insufficiency (CHAI) score in the prognostic evaluation of PVAR after balloon-expandable TAVI. The severity of PVAR was assessed immediately post TAVI by transoesophageal echocardiography (TOE) with simultaneous assessment of transcatheter haemodynamics. A total of 303 patients were studied. The CHAI score, incorporating the HR-adjusted diastolic-delta (HRA-DD, the difference between left ventricular and aortic diastolic pressures/HR*80), had a greater discriminatory value for one-year mortality than both PVAR by TOE (p=0.0018) and the previously proposed CAI score, based on the ARi without HR adjustment (p=0.0029). The CHAI score also better stratified percentage increases in left ventricular systolic chamber dimensions at one month and serum natriuretic peptide levels at one to three months. Prognostication of PVAR in the intermediate range of echocardiographic severity remains unreliable and is greatly enhanced by the integration of heart-rate-adjusted transcatheter haemodynamics.

  3. Comparison of 1-Year Outcome in Patients With Severe Aorta Stenosis Treated Conservatively or by Aortic Valve Replacement or by Percutaneous Transcatheter Aortic Valve Implantation (Data from a Multicenter Spanish Registry).

    Science.gov (United States)

    González-Saldivar, Hugo; Rodriguez-Pascual, Carlos; de la Morena, Gonzalo; Fernández-Golfín, Covadonga; Amorós, Carmen; Alonso, Mario Baquero; Dolz, Luis Martínez; Solé, Albert Ariza; Guzmán-Martínez, Gabriela; Gómez-Doblas, Juan José; Jiménez, Antonio Arribas; Fuentes, María Eugenia; Gay, Laura Galian; Ortiz, Martin Ruiz; Avanzas, Pablo; Abu-Assi, Emad; Ripoll-Vera, Tomás; Díaz-Castro, Oscar; Osinalde, Eduardo P; Martínez-Sellés, Manuel

    2016-07-15

    The factors that influence decision making in severe aortic stenosis (AS) are unknown. Our aim was to assess, in patients with severe AS, the determinants of management and prognosis in a multicenter registry that enrolled all consecutive adults with severe AS during a 1-month period. One-year follow-up was obtained in all patients and included vital status and aortic valve intervention (aortic valve replacement [AVR] and transcatheter aortic valve implantation [TAVI]). A total of 726 patients were included, mean age was 77.3 ± 10.6 years, and 377 were women (51.8%). The most common management was conservative therapy in 468 (64.5%) followed by AVR in 199 (27.4%) and TAVI in 59 (8.1%). The strongest association with aortic valve intervention was patient management in a tertiary hospital with cardiac surgery (odds ratio 2.7, 95% confidence interval 1.8 to 4.1, p <0.001). The 2 main reasons to choose conservative management were the absence of significant symptoms (136% to 29.1%) and the presence of co-morbidity (128% to 27.4%). During 1-year follow-up, 132 patients died (18.2%). The main causes of death were heart failure (60% to 45.5%) and noncardiac diseases (46% to 34.9%). One-year survival for patients treated conservatively, with TAVI, and with AVR was 76.3%, 94.9%, and 92.5%, respectively, p <0.001. One-year survival of patients treated conservatively in the absence of significant symptoms was 97.1%. In conclusion, most patients with severe AS are treated conservatively. The outcome in asymptomatic patients managed conservatively was acceptable. Management in tertiary hospitals is associated with valve intervention. One-year survival was similar with both interventional strategies. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Comparison of Outcomes of Transfemoral Transcatheter Aortic Valve Implantation Using a Minimally Invasive Versus Conventional Strategy.

    Science.gov (United States)

    Attizzani, Guilherme F; Alkhalil, Ahmad; Padaliya, Bimal; Tam, Chor-Cheung; Lopes, Joao Pedro; Fares, Anas; Bezerra, Hiram G; Medallion, Benjamin; Park, Soon; Deo, Salil; Sareyyupoglu, Basar; Parikh, Sahil; Zidar, David; Elgudin, Yakov; Popovich, Kehllee; Davis, Angela; Staunton, Elizabeth; Tomic, Ana; Mazzurco, Stacey; Avery, Edward; Markowitz, Alan; Simon, Daniel I; Costa, Marco A

    2015-12-01

    Some centers, mostly in Europe, have demonstrated the feasibility of a minimally invasive strategy (MIS; i.e., local anesthesia and conscious sedation, performed in the cath laboratory without transesophageal echocardiography guidance). Nonetheless, the experience of MIS for TAVI using both commercially available valves is lacking in the United States. We, therefore, retrospectively studied all transfemoral TAVI cases performed at our institution between March 2011 and November 2014 to assess the safety and efficacy of MIS. Patients were dichotomized according to the strategy (MIS vs conventional strategy [CS]) used for the procedure. One hundred sixteen patients were included in the MIS group and 91 patients were included in the CS group. Baseline characteristics were similar, and procedural success was comparable (99.1% in MIS and 98.9% in CS, p = 1). One intraprocedural death occurred in each group, whereas conversion rates to general anesthesia were low (3.4%). Comparable device success was obtained. Rates of complications and >mild paravalvular leak before discharge were low and comparable. Length of hospital stay was significantly reduced in the MIS (median, 3.0 [2.0 to 5.0] days) compared with than that in CS group (median 6.0 days [3.5, 8.0]). At a median follow-up of 230 days, no significant difference in survival rate was detected (89% vs 88%, p = 0.9). On average, MIS was associated with remarkable cost saving compared with CS ($16,000/case). In conclusion, TAVI through MIS was associated with a shorter postprocedural hospital stay, lower costs, and similar safety profile while keeping procedural efficacy compared with CS. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Predicting risk of atrial fibrillation after heart valve surgery: evaluation of a Brazilian risk score.

    Science.gov (United States)

    Sá, Michel Pompeu Barros de Oliveira; Sá, Marcus Villander Barros de Oliveira; Albuquerque, Ana Carla Lopes de; Silva, Belisa Barreto Gomes da; Siqueira, José Williams Muniz de; Brito, Phabllo Rodrigo Santos de; Ferraz, Paulo Ernando; Lima, Ricardo de Carvalho

    2012-01-01

    The aim of this study is to evaluate the applicability of a Brazilian score for predicting atrial fibrillation (AF) in patients undergoing heart valve surgery in the Division of Cardiovascular Surgery of Pronto Socorro Cardiológico de Pernambuco - PROCAPE (Recife, PE, Brazil). Retrospective study involving 491 consecutive patients operated between May/2007 and December/2010. The registers contained all the information used to calculate the score. The outcome of interest was AF. We calculated association of model factors with AF (univariate analysis and multivariate logistic regression analysis), and association of risk score classes with AF. The incidence of AF was 31.2%. In multivariate analysis, the four variables of the score were predictors of postoperative AF: age >70 years (OR 6.82; 95%CI 3.34-14.10; P 1500 ml at first 24 hours (OR 1.92; 95%CI 1.28-2.88; P=0.002). We observed that the higher the risk class of the patient (low, medium, high, very high), the greater is the incidence of postoperative AF (4.2%; 18.1%; 30.8%; 49.2%), showing that the model seems to be a good predictor of risk of postoperative AF, in a statistically significant association (P<0.001). The Brazilian score proved to be a simple and objective index, revealing a satisfactory predictor of development of postoperative AF in patients undergoing heart valve surgery at our institution.

  6. The failing right heart: implications and evolution in high-risk patients undergoing transcatheter aortic valve implantation.

    Science.gov (United States)

    Testa, Luca; Latib, Azeem; De Marco, Federico; De Carlo, Marco; Fiorina, Claudia; Barbanti, Marco; Montone, Rocco A; Agnifili, Mauro; Petronio, Anna Sonia; Ettori, Federica; Klugmann, Silvio; Tamburino, Corrado; Brambilla, Nedy; Colombo, Antonio; Bedogni, Francesco

    2016-12-20

    Right ventricular dysfunction (RVdy) is negatively associated with survival after left heart valve surgery. It is unclear whether RVdy has the same impact in patients undergoing transcatheter aortic valve implantation (TAVI). We sought to evaluate the prognostic impact of different grades of RVdy on TAVI, with and without concomitant left ventricular dysfunction (LVdy), and the possible impact of TAVI on RVdy. Among 870 consecutive patients with severe symptomatic aortic stenosis undergoing TAVI, 226 patients (26%) presented with a concomitant diagnosis of RVdy. Patients were divided into three groups, Group 1: normal RV systolic function, i.e., tricuspid annular plane systolic excursion (TAPSE) >16 mm (n=644, 74%); Group 2: mild-to-moderate RVdy, i.e., TAPSE 10-16 mm (n=180, 20.6%); Group 3: severe RVdy, i.e., TAPSE HR 1.5 [0.84-2.2], p=0.09), respectively. Compared to Groups 1 and 2, patients in Group 3 showed a significantly higher overall mortality at one month (22%, OR 3.3 [1.8-4.1], pHR 2.6 [2.1-3.45], pHR 1.9 [1.5-2.7], p=0.02), respectively. Pulmonary hypertension >60 mmHg (HR 1.5 [1.1-2.2], p=0.03), AF (HR 1.6 [1.1-2.4], p=0.01), creatinine clearance HR 1.92 [1.3-2.5], p=0.003), LVEF HR 1.5 [1.1-2.9], p=0.03), severe RVdy (HR 2.9 [2.7-3.3], p=0.002), severe RV dilation (HR 1.7 [1.2-2.2], p=0.005) and severe biventricular dysfunction (HR 3.9 [2.7-4.1], p=0.002) were independent predictors of one-year mortality. Among survivors, the majority of patients in Groups 2 and 3 experienced a significant improvement in NYHA class. Severe RVdy limits the expected benefit of TAVI. In current risk scores right heart failure is not considered. The present study advocates the evaluation of this strong predictor in a more complete pre-procedural work-up.

  7. Outcomes of Patients at Estimated Low, Intermediate, and High Risk Undergoing Transcatheter Aortic Valve Implantation for Aortic Stenosis.

    Science.gov (United States)

    Barbash, Israel Moshe; Finkelstein, Ariel; Barsheshet, Alon; Segev, Amit; Steinvil, Arie; Assali, Abid; Ben Gal, Yanai; Vaknin Assa, Hana; Fefer, Paul; Sagie, Alex; Guetta, Victor; Kornowski, Ran

    2015-12-15

    Intermediate- or low-risk patients with severe aortic stenosis were excluded from earlier transcatheter aortic valve implantation (TAVI) clinical trials; however, they are already being treated by TAVI despite a lack of data regarding the safety and efficacy in these patients. We aimed to assess the safety and efficacy of TAVI in patients at intermediate or low risk. Patients undergoing TAVI during 2008 to 2014 were included into a shared database (n = 1,327). Procedural outcomes were adjudicated according to Valve Academic Research Consortium 2 definitions. Patients were stratified according to their Society of Thoracic Surgeons (STS) score into 3 groups: high (STS ≥8, n = 223, 17%), intermediate (STS 4 to 8; n = 496, 38%), or low risk (STS <4; n = 576, 45%). Low-risk patients were significantly younger and more likely to be men compared to intermediate- and high-risk patients. Baseline characteristics differed significantly between the groups with a gradual increase in the rates of previous bypass surgery, stroke, peripheral vascular disease, renal failure, lung disease, and frailty scores, from low to high risk groups. Compared with intermediate- and high-risk patients, low-risk patients were more likely to undergo TAVI through the transfemoral route (81% vs 88% vs 95%, p <0.001) and under conscious sedation (69% vs 72% vs 81%, <0.001). There were no significant differences in the rates of procedural complications apart from acute kidney injury (19% vs 17% vs 13%, p = 0.03) and stroke rates (4.5% vs 2% vs 2.3%, p = 0.1). Short- and long-term mortality rates were significantly higher for intermediate- (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2 to 2.9) and high-risk patients (HR 4.1, 95% CI 2.7 to 6.4) than low-risk patients also after multivariate adjustment (HR 1.6, 95% CI 1 to 2.6 and HR 2.7, 95% CI 1.7 to 4.5, respectively; all p <0.05). In conclusion, TAVI for intermediate- and low-risk patients is safe and associated with improved outcome

  8. The design and development of a stented tissue mitral and aortic heart valve replacement for human implantation.

    Science.gov (United States)

    Legg, Murray; Mathews, Edward; Pelzer, Ruaan

    2012-04-01

    A study was conducted into the development of a mitral and aortic heart valve replacement that caters for patients having suffered valve damage due to stenosis or rheumatic fever. The appeal of the valve is that it is constituted from a solid frame housing pericardial tissue leaflets, and allows the patient freedom from post-operative blood-thinning medication. The valve is designed to appeal to patients in developing areas of the world, as it features a clip-in mechanism to secure the valve assembly into the sewing ring, which is stitched in independently of the frame and leaflets. Re-operative valve replacement would then be made possible when the pericardial leaflets began to calcify. Novel aspects of the design added value to the science of heart valve replacements, through the use of sintered chrome cobalt in the valve components, the insights gained into mechanical testing of pericardium, and the patient benefits offered by the complete design. Further work is planned to fatigue test the assembly, undergo animal trials and make the valve available for commercial use.

  9. Comparison of Ahmed glaucoma valve implantation and trabeculectomy for glaucoma: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Tan HaiBo

    Full Text Available To compare the efficacy and safety of Ahmed glaucoma valve implantation (AGV with trabeculectomy in the management of glaucoma patients.A comprehensive literature search (PubMed, Embase, Google, and the Cochrane library was performed, including a systematic review with meta-analysis of controlled clinical trials comparing AGV versus trabeculectomy. Efficacy estimates were the weighted mean differences (WMDs for the percentage intraocular pressure reduction (IOPR % from baseline to end-point, the reduction in glaucoma medications, and the odds ratios (ORs for complete and qualified success rates. Safety estimates were the relative risks (RRs for adverse events. All outcomes were reported with a 95% confidence interval (CI. Statistical analysis was performed using the RevMan 5.0 software.Six controlled clinical trials were included in this meta-analysis. There was no significant difference between the AGV and trabeculectomy in the IOPR% (WMD = -3.04, 95% CI: -8.36- 2.26; P = 0.26. The pooled ORs comparing AGV with trabeculectomy were 0.46 (0.22, 0.99 for the complete success rate (P = 0.05 and 0.97 (0.78-1.20 for the quantified success rate (P = 0.76. No significant difference in the reduction in glaucoma medicines was observed (WMD = 0.24; 95% CI: -0.27-0.76; P = 0.35. AGV was found to be associated with a significantly lower frequency of all adverse events (RR = 0.71; 95%CI: 1.14-0.97; p = 0.001 than trabeculectomy, while the most common complications did not differ significantly (all p> 0.05.AGV was equivalent to trabeculectomy in reducing the IOP, the number of glaucoma medications, success rates, and rates of the most common complications. However, AGV was associated with a significantly lower frequency of overall adverse events.

  10. Comparison of Ahmed glaucoma valve implantation and trabeculectomy for glaucoma: a systematic review and meta-analysis.

    Science.gov (United States)

    HaiBo, Tan; Xin, Kang; ShiHeng, Lu; Lin, Liu

    2015-01-01

    To compare the efficacy and safety of Ahmed glaucoma valve implantation (AGV) with trabeculectomy in the management of glaucoma patients. A comprehensive literature search (PubMed, Embase, Google, and the Cochrane library) was performed, including a systematic review with meta-analysis of controlled clinical trials comparing AGV versus trabeculectomy. Efficacy estimates were the weighted mean differences (WMDs) for the percentage intraocular pressure reduction (IOPR %) from baseline to end-point, the reduction in glaucoma medications, and the odds ratios (ORs) for complete and qualified success rates. Safety estimates were the relative risks (RRs) for adverse events. All outcomes were reported with a 95% confidence interval (CI). Statistical analysis was performed using the RevMan 5.0 software. Six controlled clinical trials were included in this meta-analysis. There was no significant difference between the AGV and trabeculectomy in the IOPR% (WMD = -3.04, 95% CI: -8.36- 2.26; P = 0.26). The pooled ORs comparing AGV with trabeculectomy were 0.46 (0.22, 0.99) for the complete success rate (P = 0.05) and 0.97 (0.78-1.20) for the quantified success rate (P = 0.76). No significant difference in the reduction in glaucoma medicines was observed (WMD = 0.24; 95% CI: -0.27-0.76; P = 0.35). AGV was found to be associated with a significantly lower frequency of all adverse events (RR = 0.71; 95%CI: 1.14-0.97; p = 0.001) than trabeculectomy, while the most common complications did not differ significantly (all p> 0.05). AGV was equivalent to trabeculectomy in reducing the IOP, the number of glaucoma medications, success rates, and rates of the most common complications. However, AGV was associated with a significantly lower frequency of overall adverse events.

  11. Changes in self-reported health and quality of life in octogenarian patients one month after transcatheter aortic valve implantation.

    Science.gov (United States)

    Olsen, Siv Js; Fridlund, Bengt; Eide, Leslie Sp; Hufthammer, Karl O; Kuiper, Karel Kj; Nordrehaug, Jan E; Skaar, Elisabeth; Norekvål, Tone M

    2017-01-01

    In addition to favourable results regarding mortality and morbidity it is important to identify the impact transcatheter aortic valve implantation (TAVI) has on patients' quality of life. The aims were: (i) to describe clinical characteristics, self-reported health and quality of life in octogenarians before TAVI intervention; (ii) to determine changes in self-reported health and quality of life one month after TAVI; and (iii) to establish the clinical importance of the findings. A prospective cohort study was conducted on consecutively enrolled octogenarians with severe aortic stenosis undergoing TAVI ( N = 65). Self-reported health and quality of life were recorded at baseline and one month later using two global questions from the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF), the generic Short Form Health 12 and the disease-specific Minnesota Living with Heart Failure Questionnaire. One month after TAVI, WHOQOL-BREF showed that self-reported health improved moderately ( p quality of life improved slightly, but not statistically significantly ( p = 0.06). There were changes in all Short Form Health 12 domains, except social functioning and role emotional. The estimated changes were 3.6 to 5.8 with large confidence intervals. The Physical Component Summary increased statistically significantly from baseline to 30 days (30.6-34.7; p = 0.02), but the Mental Component Summary did not (46.9-50.0; p = 0.13). Despite being an advanced treatment performed in a high risk population, TAVI in octogenarians improves short-term self-reported global health and generic physical health and quality of life. These patient-reported outcomes have importance, particularly in this age group.

  12. The Risk of Acute Kidney Injury and Its Impact on 30-Day and Long-Term Mortality after Transcatheter Aortic Valve Implantation

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    Katrin Gebauer

    2012-01-01

    Full Text Available Background. Transcatheter aortic valve implantation (TAVI is widely used in high risk patients (pts with aortic stenosis. Underlying chronic kidney disease implicates a high risk of postprocedural acute kidney injury (AKI. We analyzed its occurrence, impact on hospital stay, and mortality. Methods. 150 consecutive pts underwent TAVI in our institution (mean age 81 ± 7 years; logistic EuroSCORE 24 ± 15%. AKI definition was a creatinine rise of 26.5 μmol/L or more within 48 hours postprocedural. Ten patients on chronic hemodialysis were excluded. Results. AKI occurred in 28 pts (20%. Baseline creatinine was higher in AKI pts (126.4 ± 59.2 μmol/L versus 108.7 ± 45.1 μmol/L, P=0.09. Contrast media use was distributed evenly. Both, 30-day mortality (29% versus 7%, P<0.0001 and long-term mortality (43% versus 18%, P<0.0001 were higher; hospital stay was longer in AKI pts (20 ± 12 versus 15 ± 10 days, P=0.03. Predicted renal failure calculated STS Score was similar (8.0 ± 5.0% [AKI] versus 7.1 ± 4.0% [non-AKI], P=0.32 and estimated lower renal failure rates than observed. Conclusion. AKI remains a frequent complication with increased mortality in TAVI pts. Careful identification of risk factors and development of more suitable risk scores are essential.

  13. The Risk of Acute Kidney Injury and Its Impact on 30-Day and Long-Term Mortality after Transcatheter Aortic Valve Implantation

    Science.gov (United States)

    Gebauer, Katrin; Diller, Gerhard-Paul; Kaleschke, Gerrit; Kerckhoff, Gregor; Malyar, Nasser; Meyborg, Matthias; Reinecke, Holger; Baumgartner, Helmut

    2012-01-01

    Background. Transcatheter aortic valve implantation (TAVI) is widely used in high risk patients (pts) with aortic stenosis. Underlying chronic kidney disease implicates a high risk of postprocedural acute kidney injury (AKI). We analyzed its occurrence, impact on hospital stay, and mortality. Methods. 150 consecutive pts underwent TAVI in our institution (mean age 81 ± 7 years; logistic EuroSCORE 24 ± 15%). AKI definition was a creatinine rise of 26.5 μmol/L or more within 48 hours postprocedural. Ten patients on chronic hemodialysis were excluded. Results. AKI occurred in 28 pts (20%). Baseline creatinine was higher in AKI pts (126.4 ± 59.2 μmol/L versus 108.7 ± 45.1 μmol/L, P = 0.09). Contrast media use was distributed evenly. Both, 30-day mortality (29% versus 7%, P < 0.0001) and long-term mortality (43% versus 18%, P < 0.0001) were higher; hospital stay was longer in AKI pts (20 ± 12 versus 15 ± 10 days, P = 0.03). Predicted renal failure calculated STS Score was similar (8.0 ± 5.0% [AKI] versus 7.1 ± 4.0% [non-AKI], P = 0.32) and estimated lower renal failure rates than observed. Conclusion. AKI remains a frequent complication with increased mortality in TAVI pts. Careful identification of risk factors and development of more suitable risk scores are essential. PMID:23365748

  14. The 'obesity paradox' does exist in patients undergoing transcatheter aortic valve implantation for aortic stenosis: a systematic review and meta-analysis.

    Science.gov (United States)

    Lv, Wenyu; Li, Shuangjiang; Liao, Yanbiao; Zhao, Zhengang; Che, Guowei; Chen, Mao; Feng, Yuan

    2017-10-01

    Most recent studies have proposed the paradoxical benefits of obesity in surgical populations. For patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis, the prognostic roles of obesity and high body mass index remain controversial. Therefore, the objective of this meta-analysis was to evaluate whether the 'obesity paradox' exists in patients undergoing TAVI. We searched in PubMed and EMBASE to identify the eligible articles. Odds ratios and hazard ratios with the corresponding 95% confidence intervals (CI) were adopted for synthesizing short-term and long-term survival outcomes, respectively. The level of heterogeneity and the publication bias between studies were also estimated. Finally, there were 16 studies with 12 330 patients who met the eligibility criteria and who were thus included in this review. When body mass index was analysed as a continuous variable, each increase of 1 kg/m2 was significantly associated with the lower 30-day mortality rate (odds ratio = 0.95; 95% CI = 0.93-0.97; P obese patients had a significantly lower risk of 30-day mortality after TAVI than did normal patients (odds ratio = 0.69; 95% CI = 0.50-0.95; P = 0.024). Further analyses indicated that the obesity could be predictive of more favourable long-term overall survival of TAVI (hazard ratio = 0.84; 95% CI = 0.72-0.97; P = 0.021). However, we found no difference in procedural complications between the obese and normal patients. In conclusion, higher body mass index and obesity seem to have protective benefits on both short-term and long-term survival of TAVI patients. Current evidence suggests that the 'obesity paradox' may really exist in TAVI. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  15. Introducing transapical aortic valve implantation (part 1): effect of a structured training program on clinical outcome in a series of 500 procedures.

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    Pasic, Miralem; Unbehaun, Axel; Dreysse, Stephan; Buz, Semih; Drews, Thorsten; Kukucka, Marian; Mladenow, Alexander; D'Ancona, Giuseppe; Hetzer, Roland; Seifert, Burkhardt

    2013-04-01

    The purpose of the present study was to test whether the cumulative knowledge from the field of transapical transcatheter aortic valve implantation, when incorporated into a structured training and then gradually dispersed by internal proctoring, might eliminate the negative effect of the learning curve on the clinical outcomes. The present study was a retrospective, single-center, observational cohort study of prospectively collected data from all 500 consecutive high-risk patients undergoing transapical transcatheter aortic valve implantation at our institution from April 2008 to December 2011. Of the 500 patients, 28 were in cardiogenic shock. Differences during the study period in baseline characteristics, procedural and postprocedural variables, and survival were analyzed using different statistical methods, including cumulative sum charts. The overall 30-day mortality was 4.6% (95% confidence interval, 3.1%-6.8%) and was 4.0% (95% confidence interval, 2.6%-6.2%) for patients without cardiogenic shock. Throughout the study period, no significant change was seen in the 30-day mortality (Mann-Whitney U test, P = .23; logistic regression analysis, odds ratio, 0.83 per 100 patients; 95% confidence interval, 0.62-1.12; P = .23). Also, no difference was seen in survival when stratified by surgeon (30-day mortality, P = .92). An insignificant change was seen toward improved overall survival (hazard ratio, 0.90 per 100 patients; 95% confidence interval, 0.77-1.04; P = .15). The structured training program can be used to introduce transapical transcatheter aortic valve implantation and then gradually dispersed by internal proctoring to other members of the team with no concomitant detriment to patients. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  16. Systematic review and meta-analysis to compare outcomes between intermediate- and high-risk patients undergoing transcatheter aortic valve implantation.

    Science.gov (United States)

    Singh, Kuljit; Bhalla, Ajit S; Qutub, Mohammad A; Carson, Kristin; Labinaz, Marino

    2017-10-01

    Recent studies have reported non-inferior outcomes for transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in intermediate-risk patients. However, a comparison of outcomes among TAVI patients depending upon the surgical risk score has not been performed in a large study. Our aim was to compare the outcomes of TAVI in low-, intermediate-, and high-risk patients, to ascertain if the morbidity and mortality is related to the patient's risk profile or the procedure itself. A thorough computer-based search was performed using Ovid MEDLINE, EMBASE, Google Scholar, and PubMed databases. We included original research studies reporting data on TAVI in the low-, intermediate-, and high-risk groups. Patients in intermediate-risk group were compared to the high-risk cohort for device success, mortality, and complications. A total of 2414 patients in the intermediate-risk group were compared with 1597 high-risk patients. On meta-analysis, intermediate-risk group demonstrated similar device success [odds ratio (OR) 1.29, 95% confidence interval (CI) 0.87-1.90, I2 = 0%, P = 0.2) but a lower 30-day mortality OR 0.54, 95% CI 0.34-0.86, I2 = 49%, P = 0.009). There was no difference in the incidence of stroke (OR 1.17, 95% CI 0.80-1.71, I2 = 36%, P = 0.42) or permanent pacemaker implantation between the two groups (OR 1.04, 95% CI 0.82-1.32, I2 = 41%, P = 0.74). Transcatheter aortic valve implantation in intermediate-risk patients carries a low mortality and high success. Incidence of pacemaker and stroke remains high in the lower risk group.

  17. Transcatheter heart valve selection and permanent pacemaker implantation in patients with pre-existent right bundle branch block

    NARCIS (Netherlands)

    L. van Gils (Lennart); D. Tchetche (Didier); Lhermusier, T. (Thibault); M. Abawi (Masieh); N. Dumonteil (Nicolas); Olivares, R.R. (Ramón Rodriguez); de Nicolas, J.M. (Javier Molina-Martin); P.R. Stella (Pieter); D. Carrié (Didier); P.P.T. de Jaegere (Peter); N.M. van Mieghem (Nicolas)

    2017-01-01

    textabstractBackground-Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement

  18. Transcatheter heart valve selection and permanent pacemaker implantation in patients with pre-existent right bundle branch block

    NARCIS (Netherlands)

    van Gils, Lennart; Tchetche, Didier; Lhermusier, Thibault; Abawi, Masieh; Dumonteil, Nicolas; Rodriguez Olivares, R; de Nicolas, Javier Molina Martin; Stella, Pieter R.; Carrié, Didier; De Jaegere, Peter P.; Van Mieghem, Nicolas M.

    2017-01-01

    Background-Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM

  19. Comparison of the outcome of silicone Ahmed glaucoma valve implantation with a surface area between 96 and 184 mm² in adult eyes.

    Science.gov (United States)

    Koh, Kyung Min; Hwang, Young Hoon; Jung, Jong Jin; Sohn, Yong Ho; Kim, Hwang Ki

    2013-10-01

    To compare the success rates, complications, and visual outcomes between silicone Ahmed glaucoma valve (AGV) implantation with 96 mm(2) (FP8) or 184 mm(2) (FP7) surface areas. This study is a retrospective review of the records from 132 adult patients (134 eyes) that underwent silicone AGV implant surgery. Among them, the outcomes of 24 eyes from 24 patients with refractory glaucoma who underwent FP8 AGV implantation were compared with 76 eyes from 76 patients who underwent FP7 AGV implantation. Preoperative and postoperative data, including intraocular pressure (IOP), visual acuity, number of medications, and complications were compared between the 2 groups. There were no significant differences in baseline characteristics between the 2 groups (p > 0.05). The postoperative visual acuity of the patients in the FP8 group was better than that of the patients in the FP7 group in some early postoperative periods (p 0.05). Postoperative IOP was not significantly different between the 2 groups (p > 0.05) except for IOP on postoperative day 1 (11.42 mmHg for the FP7 group and 7.42 mmHg for the FP8 group; p = 0.031). There was no statistical difference in success rates, final IOP, number of medications, or complication rates between the 2 groups (p > 0.05). The FP7 and FP8 AGV implants showed no difference in terms of vision preservation, IOP reduction, and number of glaucoma medications required.

  20. Two-year survival of Ahmed valve implantation in the first 2 years of life with and without intraoperative mitomycin-C.

    Science.gov (United States)

    Al-Mobarak, Faisal; Khan, Arif O

    2009-10-01

    To evaluate the effect of intraoperative mitomycin-C (MMC) on polypropylene Ahmed glaucoma valve (AGV) survival 2 years after implantation during the first 2 years of life. Retrospective institutional comparative series (1995-2005). Thirty-one eyes of 27 patients (23 unilateral, 4 bilateral; 16 boys, 11 girls) undergoing AGV implantation at a mean age of 11.1 months (standard deviation [SD], 5.46), all of which had 2 years of regular postoperative follow-up. MMC was applied intraoperatively in those cases in the area of AGV implantation in 16 (52%) and was not applied in 15 (48%). In some eyes, MMC was applied intraoperatively in cases done by the surgeons who routinely used MMC for all AGV implantation in young children. Failure was defined as intraocular pressure (IOP) > 22 mmHg with or without glaucoma medications, the need for an additional procedure for IOP control, or the occurrence of significant complications (e.g., endophthalmitis, retinal detachment, persistent hypotony [IOP AGV implantation during the first 2 years of life. We speculate that MMC-induced tissue death can stimulate a reactive fibrosis around the AGV in very young eyes.

  1. Transcatheter aortic valve implantation. Expert Consensus of the Association of Cardiovascular Interventions of the Polish Cardiac Society and the Polish Society of Cardio-Thoracic Surgeons, approved by the Board of the Polish Cardiac Society….

    Science.gov (United States)

    Parma, Radosław; Zembala, Michał O; Dąbrowski, Maciej; Jagielak, Dariusz; Witkowski, Adam; Suwalski, Piotr; Dudek, Dariusz; Olszówka, Piotr; Wojakowski, Wojciech; Przybylski, Roman; Gil, Robert; Kuśmierczyk, Mariusz; Lesiak, Maciej; Sadowski, Jerzy; Dobrzycki, Sławomir; Ochała, Andrzej; Hoffman, Piotr; Kapelak, Bogusław; Kaźmierczak, Jarosław; Jasiński, Marek; Stępińska, Janina; Szymański, Piotr; Hryniewiecki, Tomasz; Kochman, Janusz; Grygier, Marek; Zembala, Marian; Legutko, Jacek; Różański, Jacek

    2017-01-01

    Patients with severe symptomatic aortic stenosis have a poor prognosis with medical management alone, and surgical aortic valve replacement can improve symptoms and survival. In recent years, transcatheter aortic valve implantation (TAVI) has been demonstrated to improve survival in inoperable patients and to be an alternative treatment in patients in whom the risk of surgical morbidity or mortality is high or intermediate. A representative expert committee, summoned by the Association of Cardiovascular Interventions of the Polish Cardiac Society (ACVI) and the Polish Society of Cardio-Thoracic Surgeons, devel-oped this Consensus Statement in transcatheter aortic valve implantation. It endorses the important role of a multi-disciplinary "TAVI team" in selecting patients for TAVI and defines operator and institutional requirements fundamental to the establish-ment of a successful TAVI programme. The article summarises current evidence and provides specific recommendations on organisation and conduct of transcatheter treatment of patients with aortic valve disease in Poland.

  2. Comparison of the size of artificial aortic valve with ring diameter by echocardiography

    Directory of Open Access Journals (Sweden)

    Rangbarnegad II

    1997-07-01

    Full Text Available In recent socio-economic state it is not possible to have different sets of prosthetic cardiac valves available in the operating room before open-heart surgery for valvular replacement. In this study the diameter of the aortic valve ring measured in 2-D echocardiography was compared with the size of the aortic prosthetic valves implanted for the patients with aortic valvular disease. The purpose was to find a logical correlation to help the surgeons to order the correct size of aortic prosthetic valve in advance of surgery. 26 patients with aortic valve disease were studied from 1972 till 1974 who underwent aortic valve replacement surgery. Now, it is possible to predict the accurate size of aortic mechanical valve prosthesis before surgery

  3. Beneficial effects of adjuvant intravitreal bevacizumab injection on outcomes of Ahmed glaucoma valve implantation in patients with neovascular glaucoma: systematic literature review.

    Science.gov (United States)

    Hwang, Hyung Bin; Han, Jae Wook; Yim, Hye Bin; Lee, Na Young

    2015-05-01

    We evaluated the effects of adjuvant intravitreal bevacizumab injection on the outcomes of Ahmed glaucoma valve (AGV) implantation in patients with neovascular glaucoma (NVG) through a systematic literature review. An extensive search of PubMed, EMBASE, and the Cochrane Library was performed in November 2014 for selection of relevant studies. The weighted mean difference of the percentage of intraocular pressure reduction (IOPR%) from baseline to endpoint was used as the primary efficacy estimate, and Mantel-Haenszel odds ratios and 95% confidence intervals (CIs) of the success rate were used as the secondary efficacy estimates. The incidence of adverse events was also documented through a review of the studies. Six studies involving 252 patients (256 eyes) were included in this systematic review. The differences in the means and 95% CIs of the IOPR% of 6 studies showed that adjuvant bevacizumab treatment tended to be more effective than AGV implantation alone. Comparison of the outcomes of AGV implantation only with those of AGV implantation+adjuvant bevacizumab showed a success rate in favor of AGV implantation+adjuvant bevacizumab. The incidence of bleeding-associated complications such as hyphema, vitreous hemorrhage, and suprachoroidal hemorrhage was lower in association with combination treatment than with AGV implantation only. Combination treatment seemed to be associated with a lower incidence of other adverse effects such as hypotony, flat chamber, choroidal detachment/effusion, tube-associated complications, and corneal decompensation. AGV implantation with adjuvant bevacizumab was more effective and had a higher success rate than surgery alone for lowering IOP in patients with NVG. The combined procedure tended to show a lower incidence of bleeding-associated complications, such as hyphema.

  4. Closure of a high ventricular septal defect after transcatheter aortic valve implantation with an atrial septal occluder-hybrid treatment for a rare complication.

    Science.gov (United States)

    Hamm, Karsten; Reents, Wilko; Kerber, Sebastian; Diegeler, Anno

    2017-03-01

    A patient with porcelain aorta underwent transcatheter aortic valve implantation with a self-expandable prosthesis for severe aortic stenosis. After postdilatation trace paravalvular regurgitation was accepted. 10 weeks later the patient returned with complete heart block and underwent pacemaker implantation. A new heart murmur prompted further investigation. A ventricular septal defect from the left ventricular outflow tract into the right ventricle was detected. It was successfully closed under direct surgical visualization and total cardiopulmonary bypass in an aortic no touch approach. Closure was accomplished with a percutaneous Amplatzer-PFO-occluder. Functional result was excellent. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  5. Impact on Left Ventricular Function and Remodeling and on 1-Year Outcome in Patients With Left Bundle Branch Block After Transcatheter Aortic Valve Implantation.

    Science.gov (United States)

    Carrabba, Nazario; Valenti, Renato; Migliorini, Angela; Marrani, Marco; Cantini, Giulia; Parodi, Guido; Dovellini, Emilio Vincenzo; Antoniucci, David

    2015-07-01

    Conflicting results have been reported about the prognostic impact of left bundle branch block (LBBB) after transcatheter aortic valve implantation (TAVI). The aim of this study was to evaluate the impact of LBBB after TAVI on left ventricular (LV) function and remodeling and on 1-year outcomes. Of 101 TAVI patients, 9 were excluded. All complications were evaluated according to the Valve Academic Research Consortium 2 definition. Of 92 patients, 34 developed LBBB without more advanced myocardial damage or inflammation biomarkers in comparison with patients without LBBB. The only predictor of new LBBB was larger baseline LV end-diastolic volume. LBBB plus advanced atrioventricular block was strongly correlated with permanent pacemaker implantation (p <0.0001). Patients with LBBB had a higher rate of permanent pacemaker implantation at 30 days (59% vs 19%, p <0.0001) and less recovery of LV systolic function and a trend toward a lower rate of LV reverse remodeling at 1 year. The development of acute kidney injury and the logistic European System for Cardiac Operative Risk Evaluation score were associated with poor outcomes (all-cause mortality and heart failure) (hazard ratio 6.86, 95% confidence interval 2.51 to 18.74, p <0.0001, and hazard ratio 1.04, 95% confidence interval 1.01 to 1.08, p = 0.021, respectively), but not LBBB. In conclusion, after TAVI, 37% of patients developed new LBBB without more advanced myocardial damage or inflammation biomarkers. LBBB was associated with a higher rate of permanent pacemaker implantation, which negatively affected the recovery of LV systolic function. The development of acute kidney injury, rather than LBBB, increases the 1-year risk for mortality and hospitalization for heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Predicting Lung Volume Reduction after Endobronchial Valve Therapy Is Maximized Using a Combination of Diagnostic Tools.

    Science.gov (United States)

    Koster, T David; van Rikxoort, Eva M; Huebner, Ralf-Harto; Doellinger, Felix; Klooster, Karin; Charbonnier, Jean-Paul; Radhakrishnan, Sri; Herth, Felix J F; Slebos, Dirk-Jan

    2016-01-01

    Bronchoscopic lung volume reduction using one-way endobronchial valves (EBVs) has been proven to be effective in patients with severe emphysema. However, the selection of patients without collateral ventilation prior to treatment is critical for procedural success. Collateral ventilation can be assessed directly with the Chartis system or indirectly using computed tomography (CT) fissure analysis. We retrospectively evaluated the diagnostic value of a combination of the quantitative CT interlobar fissure completeness score (FCS) and Chartis in predicting responders to EBV therapy. CT data from four prospective studies were pooled and analyzed using semiautomated software to quantify the completeness of interlobar fissures. These FCSs were compared to a reference standard of achieving ≥350 ml of target lobe volume reduction after EBV treatment. Using a receiver operating characteristic curve, optimal thresholds predictive of complete fissures (responders) and incomplete fissures (non-responders) were determined. A subgroup of patients with partially complete fissures was identified, where software had lower accuracy. The complementary value of Chartis was investigated in this group. A fissure was defined as complete (FCS >95%), incomplete (FCS <80%), or partially complete (80% < FCS < 95%). The positive predictive value (PPV) of complete fissures is 88.1%, and the negative predictive value (NPV) is 92.9%, with an overall accuracy of 89.2%. Chartis was utilized in patients with partially complete fissures, with a PPV of 82.3%, an NPV of 84.6%, and an accuracy of 83.3%. Combining diagnostic tools could reduce the burden on patients and the healthcare system while providing clinicians with a better means for patient selection for EBV therapy. © 2016 S. Karger AG, Basel.

  7. Sex differences in aortic root and vascular anatomy in patients undergoing transcatheter aortic valve implantation: A computed-tomographic study.

    Science.gov (United States)

    Hamdan, Ashraf; Barbash, Israel; Schwammenthal, Ehud; Segev, Amit; Kornowski, Ran; Assali, Abid; Shaviv, Ella; Fefer, Paul; Goitein, Orly; Konen, Eli; Guetta, Victor

    Very little data exist on the impact of sex on aortic and arterial anatomy as relevant for transcatheter aortic valve implantation (TAVI). To investigate whether patients with severe aortic stenosis (AS) referred for TAVI display sex-specific differences in aortic root and ilio-femoral artery size. In 506 patients referred for pre-procedural CT evaluation before TAVI we performed a detailed assessment of aortic root anatomy: size of the annulus and the sinus of Valsalva (SoV), diameter of the sino-tubular junction (STJ), and distance of the coronary artery ostia to the aortic annulus plane; we also determined the dimensions of aorta, subclavian, and ilio-femoral arteries. Women had significantly smaller aortic root dimensions (annulus mean diameter: 22.9 ± 2.2 mm vs. 25.7 ± 2.7 mm, SoV mean diameter: 31.8 ± 4.2 mm vs. 36.3 ± 3.8 mm, STJ mean diameter: 26.3 ± 3.4 mm vs. 29.8 ± 4.2 mm) and lower left and right coronary artery ostia take-off (12.3 ± 2.4 vs. 14.1 ± 2.9 mm; 14.8 ± 2.6 vs. 17.1 ± 3.2 mm, respectively) than men (P < 0.001 for all), even after adjustment for their smaller body surface area (BSA) and height. Dimensions of the ascending aorta, subclavian and ilio-femoral arteries were also significantly smaller in women, but not when adjusted for BSA. Women with severe AS had smaller aortic root dimensions even after correcting for their smaller body size and height, reflecting a sex-specific difference. In contrast, sex-related differences in aortic, subclavian, and ilio-femoral dimensions were fully explained by the smaller BSA of women. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  8. Impact of Mean Platelet Volume on Combined Safety Endpoint and Vascular and Bleeding Complications following Percutaneous Transfemoral Transcatheter Aortic Valve Implantation

    Directory of Open Access Journals (Sweden)

    Caroline J. Magri

    2013-01-01

    Full Text Available Background. Vascular and bleeding complications remain important complications in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF-TAVI. Platelets play an important role in bleeding events. Mean platelet volume (MPV is an indicator of platelet activation. The objective of this study was to assess whether low MPV is an indicator of major vascular and bleeding complications following TF-TAVI. Methods. A retrospective cohort study of 330 subjects undergoing TF-TAVI implantation was performed. The primary study endpoint was the occurrence of combined safety endpoint (CSEP; secondary endpoints included major vascular complications and life-threatening bleeding. Endpoints were defined according to Valve Academic Research Consortium 2. Results. The CSEP at 30 days was reached in 30.9%; major vascular complications were observed in 14.9% while life-threatening bleeding occurred in 20.6%. Logistic Euroscore and MPV were independent predictors of CSEP. Predictors of vascular complications were female sex, previous myocardial infarction, red blood cell distribution width (RDW, and MPV while predictors of life-threatening bleeding were peripheral arterial disease, RDW, and MPV. Conclusion. A low baseline MPV was shown for the first time to be a significant predictor of CSEP, major vascular complications, and life-threatening bleeding following TF-TAVI.

  9. Is primary stability a predictable parameter for loading implant?

    Directory of Open Access Journals (Sweden)

    Ratnadeep Patil

    2016-01-01

    Full Text Available Implant stability is important for osseointregration; without it, long-term success cannot be achieved. Continuous monitoring in a quantitative and objective manner is important to determine the status of implant stability. Measurement of implant stability is a valuable tool for making decisions pertaining to treatment protocol and it also improves dentist-patient communication. Owing to the invasive nature of histological analysis, various others methods have been proposed such as radiographs, cutting torque resistance, reverse torque, and resonance frequency analysis (RFA. This review focuses on the objectives and various methods to evaluate implant stability.

  10. Study of prognostic significance of antenatal ultrasonography and renin angiotensin system activation in predicting disease severity in posterior urethral valves

    Directory of Open Access Journals (Sweden)

    Divya Bhadoo

    2015-01-01

    Full Text Available Aims: Study on prognostic significance of antenatal ultrasonography and renin angiotensin system activation in predicting disease severity in posterior urethral valves. Materials and Methods: Antenatally diagnosed hydronephrosis patients were included. Postnatally, they were divided into two groups, posterior urethral valve (PUV and non-PUV. The studied parameters were: Gestational age at detection, surgical intervention, ultrasound findings, cord blood and follow up plasma renin activity (PRA values, vesico-ureteric reflux (VUR, renal scars, and glomerular filtration rate (GFR. Results: A total of 25 patients were included, 10 PUV and 15 non-PUV. All infants with PUV underwent primary valve incision. GFR was less than 60 ml/min/1.73 m 2 body surface area in 4 patients at last follow-up. Keyhole sign, oligoamnios, absent bladder cycling, and cortical cysts were not consistent findings on antenatal ultrasound in PUV. Cord blood PRA was significantly higher (P < 0.0001 in PUV compared to non-PUV patients. Gestational age at detection of hydronephrosis, cortical cysts, bladder wall thickness, and amniotic fluid index were not significantly correlated with GFR while PRA could differentiate between poor and better prognosis cases with PUV. Conclusions: Ultrasound was neither uniformly useful in diagnosing PUV antenatally, nor differentiating it from cases with non-PUV hydronephrosis. In congenital hydronephrosis, cord blood PRA was significantly higher in cases with PUV compared to non-PUV cases and fell significantly after valve ablation. Cord blood PRA could distinguish between poor and better prognosis cases with PUV.

  11. Predictability of short implants ( option for the rehabilitation of atrophic maxillae. A systematic review.

    Science.gov (United States)

    Sierra-Sánchez, J-L; García-Sala-Bonmatí, F; Martínez-González, A; García-Dalmau, C; Mañes-Ferrer, J-F; Brotons-Oliver, A

    2016-05-01

    Short implants (options available in cases of limited vertical bone. Although such implants are now widely used, there is controversy regarding their clinical reliability. The purpose of this paper is to evaluate the predictability of short implants as an alternative to technically more complex treatments in patients with atrophic maxillae, based on a systematic review of the literature and the analysis of the implant survival rates, changes in peri-implant bone level, and associated complications. It is postulated that short implants offer clinical results similar to those of longer implants. A Medline-PubMed search was made covering the period between January 2004 and December 2014 (both included). Studies in English published in indexed journals, involving at least 20 implants and with a follow-up period of at least 12 months were considered. A manual search in four high impact journals was also conducted. A total of 37 studies meeting the inclusion criteria were included in this review. 9792 implants placed in over 5000 patients were analyzed. Based on the results of this review, short implants are seen to offer clinical results in terms of survival, bone loss and complications similar to those of longer implants.

  12. Cracking a tricuspid perimount bioprosthesis to optimize a second transcatheter sapien valve-in-valve placement.

    Science.gov (United States)

    Brown, Stephen C; Cools, Bjorn; Gewillig, Marc

    2016-09-01

    Bioprosthetic valves degenerate over time. Transcatheter valve-in-valve procedures have become an attractive alternative to surgery. However, every valve increasingly diminishes the diameter of the valvar orifice. We report a 12-year-old female who had a previous transcatheter tricuspid valve-in-valve procedure; cracking the ring of a Carpentier Edwards Perimount valve by means of an ultrahigh pressure balloon allowed implantation of a further larger percutaneous valve. The advantage of this novel approach permits enlarging the inner valve diameter and may facilitate future interventions and prolong time to surgery. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  13. Transcatheter Replacement of Failed Bioprosthetic Valves

    DEFF Research Database (Denmark)

    Simonato, Matheus; Webb, John; Kornowski, Ran

    2016-01-01

    valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51-6.45; P=0.002). Conclusions-High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self-and balloon-expandable transcatheter......Background-Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets...... for implantation that would improve hemodynamics after ViV. Methods and Results-Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated...

  14. Five-year evolution of mild aortic regurgitation following transcatheter aortic valve implantation: early insights from a single-centre experience.

    Science.gov (United States)

    Buzzatti, Nicola; Castiglioni, Alessandro; Agricola, Eustachio; Barletta, Marta; Stella, Stefano; Giannini, Francesco; Regazzoli, Damiano; Mangieri, Antonio; Ancona, Marco; Spagnolo, Pietro; Chieffo, Alaide; Montorfano, Matteo; Alfieri, Ottavio; Colombo, Antonio; Latib, Azeem

    2017-07-01

    To assess the follow-up evolution and impact of mild aortic regurgitation (1 + AR) following transcatheter aortic valve implantation (TAVI). We evaluated the follow-up outcomes and AR evolution of 558 patients affected by native aortic stenosis who underwent TAVI with residual AR ≤ 1+. No residual AR was found in 294 (52.7%) patients, whereas 1 + AR was found in 264 (47.3%) patients. At 5.5 years, freedom from all-cause mortality (56.9% vs 53.5%), cardiac mortality (75.0% vs 74.3%) and heart failure (70.0% vs 63.9%) were similar between no-AR and 1 + AR groups, respectively (all P  > 0.05). New York Heart Association Class I-II was found in 88.9% vs 82.4% of patients respectively ( P  = 0.013). Freedom from AR ≥3+ at 5.5 years was 98.6% in the no-AR group vs 82.5% in the 1 + AR group (log-rank HR) 1.01, confidence interval (CI) 1.00-1.02, P  = 0.036] and heart failure rate (HR 1.01, CI 1.00-1.02, P  = 0.002), while larger native aortic annulus perimeter predicted follow-up AR ≥ 3+ (HR 1.12, CI 1.02-1.22, P  = 0.016). 5 years after TAVI, a higher progression of paravalvular AR to Grade ≥3+ together with worse symptoms were found in patients with residual 1 + AR compared with no-AR, although no marked difference in survival was observed. These findings raise further concerns about 1+ residual AR after TAVI, especially in the perspective of expanding indications to younger low-risk patients. Mechanisms that cause progression of paravalvular AR after TAVI remain to be clarified.

  15. Concomitant coronary artery disease and its management in patients referred to transcatheter aortic valve implantation: Insights from the POL-TAVI Registry.

    Science.gov (United States)

    Huczek, Zenon; Zbroński, Karol; Grodecki, Kajetan; Scisło, Piotr; Rymuza, Bartosz; Kochman, Janusz; Dąbrowski, Maciej; Witkowski, Adam; Wojakowski, Wojciech; Parma, Radosław; Ochała, Andrzej; Grygier, Marek; Olasińska-Wiśniewska, Anna; Araszkiewicz, Aleksander; Jagielak, Dariusz; Ciećwierz, Dariusz; Puchta, Dominika; Paczwa, Katarzyna; Filipiak, Krzysztof J; Wilimski, Radosław; Zembala, Marian; Opolski, Grzegorz

    2018-01-01

    Coronary artery disease (CAD) and degenerative aortic stenosis often coexist. However, the impact of CAD and its management on the prognosis after transcatheter aortic valve implantation (TAVI) remains uncertain. We sought to evaluate the impact of obstructive CAD, SYNTAX score (Ss), and percutaneous coronary intervention (PCI) prior to TAVI on short-term outcome. Overall, 896 patients who underwent TAVI after heart team decision was included. Pre-procedural angiograms were analysed to calculate baseline Ss (bSs) and residual Ss (rSs). Baseline, procedural and follow-up data up to 30 days was acquired from the national POL-TAVI registry. Patients with obstructive CAD at baseline (n = 462, 52%) had higher mortality as compared with the remaining (8.7 vs. 5.1%, log-rank P = 0.039). Also, after correction for confounding factors obstructive CAD was identified as independent predictor of mortality (hazard ratio [HR] 1.74, 95% confidence intervals [CIs] 1.03-2.94, P = 0.037). In obstructive CAD, neither bSs (AUC 0.47, CI 0.38-0.56, P = 0.47) nor rSs (AUC 0.47, CI 0.30-0.64, P = 0.72 for those undergoing PCI and AUC 0.48, CI 0.37-0.59, P = 0.75 for the remaining) was predictive of mortality. When revascularization status was considered, patients with PCI prior to TAVI had similar outcome as those without obstructive CAD at baseline (7.7 vs. 5.1%, log-rank P = 0.23) with no negative impact on mortality (HR 1.13, CI 0.62-2.09, P = 0.69). In conclusion, obstructive CAD at baseline evaluation for TAVI has independent negative impact on short-term prognosis. However, neither baseline nor residual Ss values have prognostic ability in patients undergoing TAVI. Revascularization prior to TAVI seems to improve survival to levels comparable with patients without obstructive CAD at baseline. © 2017 Wiley Periodicals, Inc.

  16. Predicting acute copper toxicity to valve closure behavior in the freshwater clam Corbicula fluminea supports the biotic ligand model.

    Science.gov (United States)

    Liao, Chung-Min; Jou, Li-John; Lin, Chieh-Ming; Chiang, Kuo-Chin; Yeh, Ching-Hung; Chou, Berry Yun-Hua

    2007-06-01

    The objective of this paper is to employ biotic ligand model (BLM) to link between acute copper (Cu) toxicity and its effect on valve closure behavior of freshwater clam Corbicula fluminea in order to further support for the BLM that potentially offers a rapid and cost-effective method to conduct the acute toxicity tests for freshwater clam exposed to waterborne Cu. Reanalysis of published experimental data of C. fluminea closure daily rhythm and dose-response profiles based on the laboratory-acclimated clams showed that a BLM-based Hill model best described the free Cu(2+)-activity-valve closure response relationships. Our proposed Cu-BLM-Corbicula model shows that free ionic form of waterborne Cu binds specifically to a biotic ligand (i.e., clam gills) and impairs normal valve closure behavior, indicating that a fixed-level of metal accumulation at a biotic ligand is required to elicit specific biological effects. With derived mechanistic-based Cu-BLM-Corbicula model, we show that the site-specific EC50(t) and valve closure behavior at any integrated time can be well predicted, indicating that our model has the potential to develop a biomonitoring system as a bioassay tool to on-line measure waterborne Cu levels in aquatic systems. Our results confirm that BLM can be improved to analytically and rigorously describe the bioavailable fraction of metal causing toxicity to valve closure behavior in freshwater C. fluminea. We suggest that the Cu-BLM-Corbicula model can be used to assist in developing technically defensible site-specific water quality criteria and performing ecological risk assessment and to promote more focused and efficient uses of resources in the regulation and control of metals and the protection of the aquatic ecosystems.

  17. First Reported Successful Femoral Valve-in-Valve Transcatheter Aortic Valve Replacement Using the Edwards Sapien 3 Valve.

    Science.gov (United States)

    Fournier, Stephane; Monney, Pierre; Roguelov, Christan; Zuffi, Andrea; Iglesias, Juan F; Qanadli, Salah D; Courbon, Cecile; Eeckhout, Eric; Muller, Olivier

    2015-10-01

    Management of degenerated aortic valve bioprosthesis classically requires redo surgery, but transcatheter aortic valve-in-valve implantation is becoming a valid alternative in selected cases. In the case of a degenerated Mitroflow bioprosthesis, TAVR is associated with an additional challenge due to a specific risk of coronary occlusion. We aimed to assess the safety and feasibility of transfemoral valve-in-valve implantation of the new Edwards Sapien 3 (Edwards Lifesciences) in a degenerated Mitroflow bioprosthesis (Sorin Group, Inc). We report here the safety and feasibility of transfemoral valve-in-valve implantation of a 23 mm Edwards Sapien 3 in a degenerated 25 mm Mitroflow valve and describe the specific assessment of the risk of coronary obstruction using a multi-imaging modality. The final result showed an absence of aortic regurgitation and a mean transvalvular gradient of 14 mm Hg. The patient had no major adverse cardiovascular events at 30-day follow-up. Transcatheter valve-in-valve implantation of an Edwards Sapien 3 in a degenerated Mitroflow is feasible and safe, considering a careful assessment of the risk of coronary obstruction with Mitroflow bioprosthesis due to leaflets mounted externally to the stent.

  18. Transcatheter valve implantation for patients with aortic stenosis: A position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

    NARCIS (Netherlands)

    A. Vahanian (Alec); O. Alfieri (Ottavio); N. Al-Attar (Nawwar); M. Antunes (Manuel); J.J. Bax (Jeroen); B. Cormier (Bertrand); A. Cribier (Alain); P.P.T. de Jaegere (Peter); G. Fournial (Gerard); A.P. Kappetein (Arie Pieter); J. Kovac (Jan); S. Ludgate (Susanne); F. Maisano (Francesco); N. Moat (Neil); F.W. Mohr (Friedrich); P. Nataf (Patrick); L. Pié rard (Luc); J.L. Pomar (Jose); J. Schofer (Joachim); P. Tornos (Pilar); M. Tuzcu (Murat); B.A. van Hout (Ben); L.K. von Segesser (Ludwig); T. Walther (Thomas)

    2008-01-01

    textabstractAims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. Methods and results: A committee of experts including European Association of Cardio-Thoracic Surgery and

  19. Success and high predictability of intraorally welded titanium bar in the immediate loading implants.

    Science.gov (United States)

    Fogli, Vaniel; Camerini, Michele; Lauritano, Dorina; Carinci, Francesco

    2014-01-01

    The implants failure may be caused by micromotion and stress exerted on implants during the phase of bone healing. This concept is especially true in case of implants placed in atrophic ridges. So the primary stabilization and fixation of implants are an important goal that can also allow immediate loading and oral rehabilitation on the same day of surgery. This goal may be achieved thanks to the technique of welding titanium bars on implant abutments. In fact, the procedure can be performed directly in the mouth eliminating possibility of errors or distortions due to impression. This paper describes a case report and the most recent data about long-term success and high predictability of intraorally welded titanium bar in immediate loading implants.

  20. Success and High Predictability of Intraorally Welded Titanium Bar in the Immediate Loading Implants

    Directory of Open Access Journals (Sweden)

    Vaniel Fogli

    2014-01-01

    Full Text Available The implants failure may be caused by micromotion and stress exerted on implants during the phase of bone healing. This concept is especially true in case of implants placed in atrophic ridges. So the primary stabilization and fixation of implants are an important goal that can also allow immediate loading and oral rehabilitation on the same day of surgery. This goal may be achieved thanks to the technique of welding titanium bars on implant abutments. In fact, the procedure can be performed directly in the mouth eliminating possibility of errors or distortions due to impression. This paper describes a case report and the most recent data about long-term success and high predictability of intraorally welded titanium bar in immediate loading implants.

  1. The Prognostic Impact of New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Implantation: A Meta-analysis.

    Science.gov (United States)

    Ando, Tomo; Takagi, Hisato

    2016-09-01

    New-onset persistent left bundle branch block (NOP-LBBB) is one of the most common conduction disturbances after transcatheter aortic valve implantation (TAVI). We hypothesized that NOP-LBBB may have a clinically negative impact after TAVI. To find out, we conducted a systematic literature search of the MEDLINE/PubMed and Embase databases. Observational studies that reported clinical outcomes of NOP-LBBB patients after TAVI were included. The random-effects model was used to combine odds ratios, risk ratios, or hazard ratios (HRs) with 95% confidence intervals. Adjusted HRs were utilized over unadjusted HRs or risk ratios when available. A total of 4049 patients (807 and 3242 patients with and without NOP-LBBB, respectively) were included. Perioperative (in-hospital or 30-day) and midterm all-cause mortality and midterm cardiovascular mortality were comparable between the groups. The NOP-LBBB patients experienced a higher rate of permanent pacemaker implantation (HR: 2.09, 95% confidence interval: 1.12-3.90, P = 0.021, I(2) = 83%) during midterm follow-up. We found that NOP-LBBB after TAVI resulted in higher permanent pacemaker implantation but did not negatively affect the midterm prognosis. Therefore, careful observation during the follow-up is required. © 2016 Wiley Periodicals, Inc.

  2. Pre-operative Tei Index does not predict left ventricular function immediately after mitral valve repair

    Directory of Open Access Journals (Sweden)

    Chirojit Mukherjee

    2012-01-01

    Full Text Available Echocardiographic assessment of systolic left ventricular (LV function in patients with severe mitral regurgitation (MR undergoing mitral valve (MV repair can be challenging because the measurement of ejection fraction (EF or fractional area change (FAC in pathological states is of questionable value. The aim of our study was to evaluate the usefulness of the pre-operative Tei Index in predicting left ventricular EF or FAC immediately after MV repair. One hundred and thirty patients undergoing MV repair with sinus rhythm pre- and post-operatively were enrolled in this prospective study. Twenty-six patients were excluded due to absence of sinus rhythm post-operatively. Standard transesophageal examination(IE 33,Philips,Netherlands was performed before and after cardiopulmonary bypass according to the guidelines of the ASE/SCA. FAC was determined in the transgastric midpapillary short-axis view. LV EF was measured in the midesophageal four- and two-chamber view. For calculation of the Tei Index, the deep transgastric and the midesophageal four-chamber view were used. Statistical analysis was performed with SPSS 17.0. values are expressed as mean with standard deviation. LV FAC and EF decreased significantly after MV repair (FAC: 56±12% vs. 50±14%, P<0.001; EF: 58±11 vs. 50±12Έ P<0.001. The Tei Index decreased from 0.66±0.23 before MV repair to 0.41±0.19 afterwards (P<0.001. No relationship between pre-operative Tei Index and post-operative FAC or post-operative EF were found (FAC: r=−0.061, P=0.554; EF: r=−0.29, P=0.771. Conclusion: Pre-operative Tei Index is not a good predictor for post-operative FAC and EF in patients undergoing MV repair.

  3. Simultaneous repair of pectus excavatum and pulmonary valve implantation years after complete repair of tetralogy of Fallot.

    Science.gov (United States)

    Tuncer, Eylem; Vuran, Ali Can; Ozyuksel, Arda; Yeginsu, Ali; Ceyran, Hakan

    2017-02-01

    Although pectus excavatum is a common congenital abnormality of the chest wall, its coexistence with congenital heart defects is rarely encountered. In this report, we present a young adult who was re-operated for pulmonary valve regurgitation and pectus excavatum years after complete repair of tetralogy of Fallot. The surgical challenge and pitfalls are discussed along with a brief review of the literature.

  4. Outcomes in patients with contained ruptures of the aortic annulus after transcatheter aortic valve implantation with balloon-expandable devices

    DEFF Research Database (Denmark)

    Breitbart, Philipp; Minners, Jan; Pache, Gregor

    2017-01-01

    ) at three centers in Germany and Denmark. CR were identified in 12 patients (1.2%, 80.7+5.0 years, STS-Score 4.1+1.4%). All 12 patients had received a balloon-expandable valve. In 3 patients periprocedural transesophageal echocardiography revealed findings suggestive of aortic dissection, an aortic...

  5. High-degree atrioventricular block in patients with preexisting bundle branch block or bundle branch block occurring during transcatheter aortic valve implantation.

    Science.gov (United States)

    Egger, Florian; Nürnberg, Michael; Rohla, Miklos; Weiss, Thomas W; Unger, Gerhard; Smetana, Peter; Geppert, Alexander; Gruber, Susanne C; Bambazek, Anton; Falkensammer, Jürgen; Waldenberger, Ferdinand R; Huber, Kurt; Freynhofer, Matthias K

    2014-12-01

    Transcatheter aortic valve implantation (TAVI) has become the standard therapy for high-risk and non-operable patients with severe aortic stenosis. However, the procedure involves several adverse effects, such as rhythm and conduction disturbances. Patients with postprocedural left bundle branch block may have an increased mortality risk, whereas patients with preprocedural right bundle branch block display a higher rate of postinterventional bradyarrhythmias. The purpose of this study was to investigate the occurrence of high-degree atrioventricular block (AVB) in patients with preexisting bundle branch block (BBB) or BBB occurring during TAVI. In this prospective single-center study, 50 consecutive patients undergoing TAVI with the Medtronic CoreValve Revalving System were included. Of these patients, 17 with preexisting BBB or BBB occurring during TAVI received a primary prophylactic permanent DDD pacemaker, programmed to the SafeR-mode and featuring dual-channel event counters as well as stored intracardiac electrograms. Pacemaker readouts and intracardiac electrograms were analyzed for the occurrence of high-degree AVB. Ten of 17 patients (58.8%) with preexisting BBB or BBB occurring during TAVI developed episodes of high-degree AVB that were immediately terminated due to switch into DDD backup pacing. In 5 of the cases (29.4%), the first documented episode of high-degree AVB occurred after hospital discharge. Mean follow-up period was 578.1 ± 294.9 days. Development of high-degree AVB is a common complication in patients with preexisting BBB or BBB occurring during TAVI. Accordingly, intensified monitoring might be reasonable, especially in patients treated with the self-expandable Medtronic CoreValve Revalving System. Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  6. Effect of gender differences on 1-year mortality after transcatheter aortic valve implantation for severe aortic stenosis: results from a multicenter real-world registry.

    Science.gov (United States)

    Sherif, Mohammad A; Zahn, Ralf; Gerckens, Ulrich; Sievert, Horst; Eggebrecht, Holger; Hambrecht, Rainer; Sack, Stefan; Richardt, Gert; Schneider, Steffen; Senges, Jochen; Brachmann, Johannes

    2014-08-01

    The aim of this analysis is to examine the influence of gender differences on the outcome after transcatheter aortic valve implantation (TAVI) from a multicenter real-world registry in Germany (TAVI registry). The impact of gender differences on the clinical outcome after TAVI was examined in small studies with conflicting results. Consecutive patients (n = 1,432) undergoing TAVI in the period between January 2009 and June 2010 in Germany were evaluated. Differences in all-cause mortality were examined with Kaplan-Meier estimates and proportional hazards models. Women comprised 57.8 % of the cohort. The Edwards Sapien valve (18.5 %) and CoreValve (81.5 %) were used through the transfemoral (87.7 %), subclavian (3.0 %), transapical (8.6 %), or transaortic approach (0.7 %). At baseline, women had higher aortic gradients and were older. Men had more comorbidities: prior myocardial infarction, prior revascularization, prior coronary artery bypass surgery, peripheral arterial vascular disease and chronic obstructive pulmonary disease. Women had more periprocedural vascular complications in comparison to men (25.2 vs. 17.2 %, p < 0.001). There was no significant difference in mortality at 30-day follow-up (7.6 % for women vs. 8.6 % for men, p = 0.55). The adjusted HR for 1-year all-cause mortality favored women, HR 0.75 (95 % CI 0.57-0.98, p = 0.0346) with a mortality rate of 17.3 vs. 23.6 % for men. Female gender is associated with better 1-year survival after TAVI. These results suggest that TAVI could be the best treatment modality for elderly women with symptomatic severe aortic stenosis.

  7. Using Clinical Decision Support and Dashboard Technology to Improve Heart Team Efficiency and Accuracy in a Transcatheter Aortic Valve Implantation (TAVI) Program.

    Science.gov (United States)

    Clarke, Sarah; Wilson, Marisa L; Terhaar, Mary

    2016-01-01

    Heart Team meetings are becoming the model of care for patients undergoing transcatheter aortic valve implantations (TAVI) worldwide. While Heart Teams have potential to improve the quality of patient care, the volume of patient data processed during the meeting is large, variable, and comes from different sources. Thus, consolidation is difficult. Also, meetings impose substantial time constraints on the members and financial pressure on the institution. We describe a clinical decision support system (CDSS) designed to assist the experts in treatment selection decisions in the Heart Team. Development of the algorithms and visualization strategy required a multifaceted approach and end-user involvement. An innovative feature is its ability to utilize algorithms to consolidate data and provide clinically useful information to inform the treatment decision. The data are integrated using algorithms and rule-based alert systems to improve efficiency, accuracy, and usability. Future research should focus on determining if this CDSS improves patient selection and patient outcomes.

  8. Editorial to: Baseline MDCT findings after prosthetic heart valve implantation provide important complementary information to echocardiography for follow-up purposes by Sucha et al

    Energy Technology Data Exchange (ETDEWEB)

    Peeters, F.E.C.M. [Maastricht University Medical Center, Department of Cardiology, Maastricht (Netherlands); Kietselaer, B.L.J.H. [Maastricht University Medical Center, Department of Cardiology, Maastricht (Netherlands); Maastricht University Medical Center, Department of Radiology, Maastricht (Netherlands)

    2016-04-15

    Over the last years a growing number of prosthetic heart valve (PHV) implantation procedures have been performed in sequence with the aging of the population and improving surgical techniques. Currently, echocardiography is the most important tool in the follow-up and evaluation of complications associated with the PHV (pannus, thrombus, endocarditis). However, echocardiographic examination of PHV associated disease may be hampered by poor acoustic window or scatter artefacts caused by the PHV. PHV related disease such as endocarditis is related with a poor prognosis, especially when complications such as periannular abscess formation occurs. Early treatment of PHV associated disease improves prognosis. Therefore, an unmet clinical need for early detection of complications exists. In the evaluation of PHV (dys)function, multidetector-row computed tomography (MDCT) has shown to be of additive value. A necessity for MDCT to be implemented in daily practice is to be able to distinguish between normal and pathological features. (orig.)

  9. Comparison of Outcome of Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis in 3 Age Groups (≤70; 71 to 80, and ≥81 Years).

    Science.gov (United States)

    Regev, Ehud; Finkelstein, Ariel; Assali, Abid; Barbash, Israel; Fefer, Paul; Ben-Shoshan, Jeremy; Orvin, Katia; Konigstein, Maayan; Guetta, Victor; Kornowski, Ran; Segev, Amit

    2017-11-01

    Transcatheter aortic valve implantation (TAVI) has been widely used for the treatment of aortic stenosis. Most pivotal studies of TAVI included patients with a mean age of over 80 years old. Many young patients may also be considered for TAVI because of severe co-morbidities. We sought to describe a group of patients undergoing TAVI at an age below 70 and to compare them with older patients undergoing the procedure. This study included 1,324 consecutive patients from a 3-center TAVI registry from 2008 to 2014. Patients were divided according to age into 3 groups: patients aged 70 years and below, patients between the ages of 71 and 80, and patients 81 years and older. Patients in the younger group had higher body mass index (p 80 years was 7.6%, 7.5%, and 12.6%, respectively, p = 0.01. In conclusion, younger patients undergoing TAVI exhibited higher prevalence of risk factors and co-morbidities that probably explain the decision to perform TAVI rather than surgical aortic valve replacement. Nevertheless, the 1-year mortality of these patients was significantly lower than in older patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Narrow-diameter implants: are they a predictable treatment option? A literature review.

    Science.gov (United States)

    Sierra-Sánchez, José-Luis; Martínez-González, Amparo; García-Sala Bonmatí, Fernando; Mañes-Ferrer, José-Félix; Brotons-Oliver, Alejandro

    2014-01-01

    To evaluate the predictability of narrow-diameter implants as a treatment option in routine clinical practice. A literature review was performed of studies reporting clinical results obtained with these implants. Survival rates, peri-implant bone loss and related complications were evaluated. The working hypothesis was that narrow-diameter implants offer clinical results similar to those obtained with implants of greater diameter. A Medline-PubMed search covering the period between 2002 and 2012 was carried out. Studies published in English and with a follow-up period of at least 12 months were considered for inclusion. A manual search was also conducted in different journals with an important impact factor. results: Twenty-one studies meeting the screening criteria were included in the literature review. A total of 2980 narrow-diameter implants placed in 1607 patients were analyzed. The results obtained from the literature indicate that narrow-diameter implants are a predictable treatment option, since they afford clinical results comparable to those obtained with implants of greater diameter.

  11. Efficacy and safety of intravitreal ranibizumab with panretinal photocoagulation followed by trabeculectomy compared with Ahmed glaucoma valve implantation in neovascular glaucoma.

    Science.gov (United States)

    Sun, Jin-Tao; Liang, Hai-Jing; An, Meng; Wang, Da-Bo

    2017-01-01

    To evaluate the efficacy and safety of intravitreal ranibizumab (IVR) with panretinal photocoagulation (PRP) followed by trabeculectomy compared with Ahmed glaucoma valve (AGV) implantation in neovascular glaucoma (NVG). This was a retrospective comparative study. We reviewed the cases of a total of 45 eyes from 45 NVG patients among which 23 eyes underwent AGV implantation and the other 22 underwent trabeculectomy. The causes of neovascular glaucoma included: diabetic retinopathy (25 eyes), and retinal vein occlusion (20 eyes). All patients received preoperative IVR combined with postoperative PRP. The mean best-corrected visual acuities (BCVA) were converted to the logarithms of the minimum angle of resolution (logMAR) for the statisitical analyses. Intraocular pressure (IOP), the logMAR BCVA and surgical complications were evaluated before and after surgery. The follow-up period was 12mo. A total of 39 cases showed complete regression of iris neovascularization at 7d after injection, and 6 cases showed a small amount of residual iris neovascularization. The success rates were 81.8% and 82.6% at 12mo after trabeculectomy and AGV implantation, respectively. In the trabeculectomy group, the logMAR BCVA improved at the last follow-up in 14 eyes, remained stable in 6 eyes and decreased in 2 eyes. In 4 cases, slight hyphemas developed after trabeculectomy. A shallow anterior chamber developed in 2 cases and 2 vitreous hemorrhages. In the AGV group, the logMAR BCVA improved in 14 eyes, remained stable in 5 eyes and decreased in 4 eyes. Slight hyphemas developed in 3 cases, and a shallow anterior chamber in 3 cases. The mean postoperative IOP was significantly lower in both groups after surgery (F=545.468, PAGV implantation+PRP and IVR+trabeculectomy+PRP in eyes with NVG.

  12. Short-term to Long-term Results of Ahmed Glaucoma Valve Implantation for Uveitic Glaucoma Secondary to Behçet Disease.

    Science.gov (United States)

    Yakin, Mehmet; Eksioglu, Umit; Sungur, Gulten; Satana, Banu; Demirok, Gulizar; Ornek, Firdevs

    2017-01-01

    To evaluate short-term to long-term outcomes of Ahmed glaucoma valve (AGV) implantation in the management of uveitic glaucoma (UG) secondary to Behçet disease (BD). A retrospective chart review of 47 eyes of 35 patients with UG secondary to BD who underwent AGV implantation was conducted. Success was defined as having an intraocular pressure (IOP) between 6 and 21 mm Hg with (qualified success) or without (complete success) antiglaucomatous medications and without need for further glaucoma surgery. Mean postoperative follow-up was 57.72±26.13 months. Mean preoperative IOP was 35.40±8.33 mm Hg versus 12.28±2.90 mm Hg at the last follow-up visit (P<0.001). Mean number of preoperative topical antiglaucomatous medications was 2.96±0.29 versus 0.68±1.12 at the last follow-up visit (P<0.001). In all eyes, IOP could be maintained between 6 and 21 mm Hg with or without antiglaucomatous medications during follow-up. The cumulative probability of complete success was 46.8% at 6 months, 40.4% at 12 months, and 35.9% at 36 months, and the cumulative probability of eyes without complication was 53.2% at 6 months, 46.5% at 12 months, and 39.6% at 24 months postoperatively based on Kaplan-Meier survival analysis. No persistent or irreparable complications were observed. This study includes one of the largest series of AGV implantation in the management of UG with the longest follow-up reported. AGV implantation can be considered as a primary surgical option in the management of UG secondary to BD with 100% total success rate (with or without medications).

  13. Preoperative implant planning considering alveolar bone grafting needs and complication prediction using panoramic versus CBCT images

    Energy Technology Data Exchange (ETDEWEB)

    Guerrero, Maria Eugenia; Jacobs, Reinhilde [OIC, OMFS IMPATH Research Group, Department of Imaging and Pathology, Faculty of Medicine, University of Leuven, Leuven (Belgium); Noriega, Jorge [Master of Periodontology, Universidad San Martin de Porres, Lima (Peru)

    2014-09-15

    This study was performed to determine the efficacy of observers' prediction for the need of bone grafting and presence of perioperative complications on the basis of cone-beam computed tomography (CBCT) and panoramic radiographic (PAN) planning as compared to the surgical outcome. One hundred and eight partially edentulous patients with a need for implant rehabilitation were referred for preoperative imaging. Imaging consisted of PAN and CBCT images. Four observers carried out implant planning using PAN image datasets, and at least one month later, using CBCT image datasets. Based on their own planning, the observers assessed the need for bone graft augmentation as well as complication prediction. The implant length and diameter, the need for bone graft augmentation, and the occurrence of anatomical complications during planning and implant placement were statistically compared. In the 108 patients, 365 implants were installed. Receiver operating characteristic analyses of both PAN and CBCT preoperative planning showed that CBCT performed better than PAN-based planning with respect to the need for bone graft augmentation and perioperative complications. The sensitivity and the specificity of CBCT for implant complications were 96.5% and 90.5%, respectively, and for bone graft augmentation, they were 95.2% and 96.3%, respectively. Significant differences were found between PAN-based planning and the surgery of posterior implant lengths. Our findings indicated that CBCT-based preoperative implant planning enabled treatment planning with a higher degree of prediction and agreement as compared to the surgical standard. In PAN-based surgery, the prediction of implant length was poor.

  14. Can postoperative mean transprosthetic pressure gradient predict survival after aortic valve replacement?

    NARCIS (Netherlands)

    Koene, Bart M.; Hamad, Mohamed A. Soliman; Bouma, Wobbe; Mariani, Massimo A.; Peels, Kathinka C.; van Dantzig, Jan-Melle; van Straten, Albert H.

    In this study, we sought to determine the effect of the mean transprosthetic pressure gradient (TPG), measured at 6 weeks after aortic valve replacement (AVR) or AVR with coronary artery bypass grafting (CABG) on late all-cause mortality. Between January 1998 and March 2012, 2,276 patients (mean age

  15. The predictive value of microbiological findings on teeth, internal and external implant portions in clinical decision making.

    Science.gov (United States)

    Canullo, Luigi; Radovanović, Sandro; Delibasic, Boris; Blaya, Juan Antonio; Penarrocha, David; Rakic, Mia

    2017-05-01

    The primary aim of this study was to evaluate 23 pathogens associated with peri-implantitis at inner part of implant connections, in peri-implant and periodontal pockets between patients suffering peri-implantitis and participants with healthy peri-implant tissues; the secondary aim was to estimate the predictive value of microbiological profile in patients wearing dental implants using data mining methods. Fifty participants included in the present case─control study were scheduled for collection of plaque samples from the peri-implant pockets, internal connection, and periodontal pocket. Real-time polymerase chain reaction was performed to quantify 23 pathogens. Three predictive models were developed using C4.5 decision trees to estimate the predictive value of microbiological profile between three experimental sites. The final sample included 47 patients (22 healthy controls and 25 diseased cases), 90 implants (43 with healthy peri-implant tissues and 47 affected by peri-implantitis). Total and mean pathogen counts at inner portions of the implant connection, in peri-implant and periodontal pockets were generally increased in peri-implantitis patients when compared to healthy controls. The inner portion of the implant connection, the periodontal pocket and peri-implant pocket, respectively, presented a predictive value of microbiologic profile of 82.78%, 94.31%, and 97.5% of accuracy. This study showed that microbiological profile at all three experimental sites is differently characterized between patients suffering peri-implantitis and healthy controls. Data mining analysis identified Parvimonas micra as a highly accurate predictor of peri-implantitis when present in peri-implant pocket while this method generally seems to be promising for diagnosis of such complex infections. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. Prediction of dental implant torque with a fast and automatic finite element analysis: a pilot study.

    Science.gov (United States)

    Bardyn, Thibaut; Gédet, Philippe; Hallermann, Wock; Büchler, Philippe

    2010-04-01

    Despite its importance, implant removal torque can be assessed at present only after implantation. This paper presents a new technique to help clinicians preoperatively evaluate implant stability. Planning software has been combined with an in-house finite element solver. Once the clinician has chosen the implant position on the planner, a finite element analysis automatically calculates the primary stability. The process was designed to be as simple and fast as possible for clinical use. This paper describes application of the method to the prediction of removal torque. A preliminary validation has been performed in both polyurethane foam and sheep bone. The predicted torque is quantitatively equivalent to experimental values with correlation coefficients of >0.7 in both materials. This preliminary study is a first step toward the introduction of finite element models in computer-assisted surgery. The fact that the process is fast and automatic makes it suitable for a clinical use. Copyright 2010 Mosby, Inc. All rights reserved.

  17. FATIGUE LIFE PREDICTION OF COMMERCIALLY PURE TITANIUM AFTER NITROGEN ION IMPLANTATION

    Directory of Open Access Journals (Sweden)

    Nurdin Ali

    2013-06-01

    Full Text Available Prediction of fatigue life has become an interesting issue in biomaterial engineering and design for reliability and quality purposes, particularly for biometallic material with modified surfaces. Commercially pure titanium (Cp-Ti implanted with nitrogen ions is a potential metallic biomaterial of the future. The effect of nitrogen ion implantation on fatigue behavior of Cp-Ti was investigated by means of axial loading conditions. The as-received and nitrogen-ion implanted specimens with the energy of 100 keV and dose of 2 × 1017 ions cm-2, were used to determine the fatigue properties and to predict the life cycle of the specimens. The effect of nitrogen ion implantation indicated revealed improved the tensile strength due to the formation of nitride phases, TiN and Ti2N. The fatigue strength of Cp-Ti and Nii-Ti was 250 and 260 MPa, respectively. The analytical results show good agreement with experimental results.

  18. Update of transcatheter valve treatment.

    Science.gov (United States)

    Liu, Xian-bao; Wang, Jian-an

    2013-08-01

    Transcatheter valve implantation or repair has been a very promising approach for the treatment of valvular heart diseases since transcatheter aortic valve implantation (TAVI) was successfully performed in 2002. Great achievements have been made in this field (especially TAVI and transcatheter mitral valve repair--MitraClip system) in recent years. Evidence from clinical trials or registry studies has proved that transcatheter valve treatment for valvular heart diseases is safe and effective in surgical high-risk or inoperable patients. As the evidence accumulates, transcatheter valve treatment might be an alterative surgery for younger patients with surgically low or intermediate risk valvular heart diseases in the near future. In this paper, the updates on transcatheter valve treatment are reviewed.

  19. A comparative study between diode laser cyclophotocoagulation and the Ahmed glaucoma valve implant in neovascular glaucoma: a long-term follow-up.

    Science.gov (United States)

    Yildirim, Nilgun; Yalvac, Ilgaz Sagdic; Sahin, Afsun; Ozer, Ahmet; Bozca, Tark

    2009-03-01

    To compare the efficacy, safety, and long-term results of intraocular pressure (IOP) reduction by diode laser contact cyclophotocoagulation (DCPC) and Ahmed glaucoma valve (AGV) implant in cases of neovascular glaucoma. A total of 66 eyes of 66 patients with neovascular glaucoma were prospectively assigned to either DCPC or AGV implantation. All patients underwent a baseline complete ophthalmologic examination and IOP measurement by Goldmann applanation tonometry before and after 1,3, 6, 12, and 24 months follow-up. Complications and the number of medications were recorded. Mean age of the patients was 60.0+/-11.7 years (range: 20 to 85) in the DCPC group and 57.2+/-10.3 years (range: 20 to 85) in the AGV group. The preoperative IOP was 43.4+/-11.9 mm Hg and 43.3+/-7.4 mm Hg for the DCPC and AGV group, respectively (P>0.05). The postoperative IOP was 16.5+/-11.3 mm Hg and 22.09+/-7.6 mm Hg for the DCPC and AGV groups, respectively (P>0.05) at the last visit. Kaplan-Meier survival analysis showed a probability of success at 24 months of 61.18% and 59.26% for the DCPC and AGV groups (P>0.05). All the patients had a visual acuity of hand movement or worse preoperatively. Visual acuity decreased in 6 eyes (24%) in the DCPC group and 9 eyes (27%) in AGV group. Complications included anterior segment inflammation in 5 eyes (20%), neurotrophic keratitis in 2 eyes (8%), and hypotony in 3 eyes (15%) in the DCPC group and hyphema in 5 eyes (15%) and tube occlusion in 3 eyes (9%) in AGV group. There was no significant difference in the success rate between the DCPC and AGV implantation in neovascular glaucoma treatment. However, DCPC is less time consuming and easier method for lowering IOP in patients with neovascular glaucoma.

  20. [Multidimensional geriatric assessment before transcatheter aortic valve implantation in frail elderly patients with one-year follow-up. Cardio-geriatrician collaboration benefits?].

    Science.gov (United States)

    Damier, E; Chidlovskii, E; Bertrand, B; Dang, V M; Vanzetto, G; Couturier, P

    2016-09-01

    Transcatheter aortic valve implantation (TAVI) is a treatment for high-risk patients with symptomatic severe aortic stenosis. The aim of the study is to assess results of comprehensive geriatric assessment before TAVI and geriatrician advices about TAVI procedure feasibility. We report one-year outcomes after TAVI procedure. All patients who underwent comprehensive geriatric assessment in geriatric day hospital before TAVI were prospectively included in Grenoble. We report characteristics of the patients, geriatrician advices about TAVI procedure feasibility and risks, and one year follow-up. Twenty-one frail elderly patients underwent geriatric assessment. The mean age was 85.4; demographics included cognitive impairment (76%), renal dysfunction (81%), NYHA functional class III or IV (48%). Eighteen patients were suitable for TAVI according to geriatric assessment, 8 underwent TAVI. None of the 3 patients who were not candidate for TAVI according to geriatricians were implanted. Cardiologists followed geriatrician advices for 56% of cases. Intensive care unit and cardiology stay were prolonged at 3.5 and 7.9days, respectively. Six out of the 8 patients stayed in rehabilitation unit after TAVI. None of the implanted patients died at one-year follow up, despite of the common periprocedural complications: acute kidney injury, ischemic stroke, delirium, pacemaker, hemorrhage. Cardiologists follow geriatrician advices about TAVI feasibility in frail elderly patients. Comprehensive geriatric assessment also helps preventing complications and providing quick assessment of occurring periprocedural and postprocedural complications. Optimal management of frail elderly patients undergoing TAVI is a multidisciplinary task involving cardiologists, anaesthetists and geriatricians. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  1. Comparison of hinge microflow fields of bileaflet mechanical heart valves implanted in different sinus shape and downstream geometry.

    Science.gov (United States)

    Kuan, Yee Han; Kabinejadian, Foad; Nguyen, Vinh-Tan; Su, Boyang; Yoganathan, Ajit P; Leo, Hwa Liang

    2015-01-01

    The characterization of the bileaflet mechanical heart valves (BMHVs) hinge microflow fields is a crucial step in heart valve engineering. Earlier in vitro studies of BMHV hinge flow at the aorta position in idealized straight pipes have shown that the aortic sinus shapes and sizes may have a direct impact on hinge microflow fields. In this paper, we used a numerical study to look at how different aortic sinus shapes, the downstream aortic arch geometry, and the location of the hinge recess can influence the flow fields in the hinge regions. Two geometric models for sinus were investigated: a simplified axisymmetric sinus and an idealized three-sinus aortic root model, with two different downstream geometries: a straight pipe and a simplified curved aortic arch. The flow fields of a 29-mm St Jude Medical BMHV with its four hinges were investigated. The simulations were performed throughout the entire cardiac cycle. At peak systole, recirculating flows were observed in curved downsteam aortic arch unlike in straight downstream pipe. Highly complex three-dimensional leakage flow through the hinge gap was observed in the simulation results during early diastole with the highest velocity at 4.7 m/s, whose intensity decreased toward late diastole. Also, elevated wall shear stresses were observed in the ventricular regions of the hinge recess with the highest recorded at 1.65 kPa. Different flow patterns were observed between the hinge regions in straight pipe and curved aortic arch models. We compared the four hinge regions at peak systole in an aortic arch downstream model and found that each individual hinge did not vary much in terms of the leakage flow rate through the valves.

  2. Predictive value of natriuretic peptides in dogs with mitral valve disease

    DEFF Research Database (Denmark)

    Tarnow, Inge; Olsen, Lisbeth Høier; Kvart, Clarence

    2009-01-01

    Natriuretic peptides are useful in diagnosing heart failure in dogs. However, their usefulness in detecting early stages of myxomatous mitral valve disease (MMVD) has been debated. This study evaluated N-terminal (NT) fragment pro-atrial natriuretic peptide (NT-proANP) and NT-pro-brain natriuretic...... peptide (NT-proBNP) in 39 Cavalier King Charles Spaniels (CKCS) with pre-clinical mitral valve regurgitation (MR), sixteen dogs with clinical signs of heart failure (HF) and thirteen healthy control dogs. Twenty seven CKCS and ten control dogs were re-examined 4 years after the initial examination...... and the status of the dogs 5 years after the initial examination was determined by telephone calls to the owner. All dogs were evaluated by clinical examination and echocardiography. CKCS with severe MR had higher NT-proANP and NT-proBNP compared to controls and CKCS with less severe MR. Dogs with clinical signs...

  3. [The Starr-Edwards heart valve: one of the oldest mechanical heart valves still functioning today].

    Science.gov (United States)

    Schoenaker, Michiel H; van Wetten, Herbert B; Morshuis, Wim J

    2015-01-01

    In the 1960s, the Starr-Edwards valve was the first artificial heart valve to be successfully implanted in humans. This valve has now been in use for decades with outstanding results: patients whose life expectancy had previously been short acquired a good prognosis with this development. Nowadays the Starr-Edwards valve is not used anymore, but patients are being described today in whom these valves are still functioning well after more than 40 years.

  4. Prediction of coronary artery disease in patients undergoing operations for mitral valve degeneration

    Science.gov (United States)

    Lin, S. S.; Lauer, M. S.; Asher, C. R.; Cosgrove, D. M.; Blackstone, E.; Thomas, J. D.; Garcia, M. J.

    2001-01-01

    OBJECTIVES: We sought to develop and validate a model that estimates the risk of obstructive coronary artery disease in patients undergoing operations for mitral valve degeneration and to demonstrate its potential clinical utility. METHODS: A total of 722 patients (67% men; age, 61 +/- 12 years) without a history of myocardial infarction, ischemic electrocardiographic changes, or angina who underwent routine coronary angiography before mitral valve prolapse operations between 1989 and 1996 were analyzed. A bootstrap-validated logistic regression model on the basis of clinical risk factors was developed to identify low-risk (diabetes mellitus,and hyperlipidemia. Two hundred twenty patients were designated as low risk according to the logistic model. Of these patients, only 3 (1.3%) had single-vessel disease, and none had multivessel disease. The model showed good discrimination, with an area under the receiver-operating characteristic curve of 0.84. Cost analysis indicated that application of this model could safely eliminate 30% of coronary angiograms, corresponding to cost savings of $430,000 per 1000 patients without missing any case of high-risk coronary artery disease. CONCLUSION: A model with standard clinical predictors can reliably estimate the prevalence of obstructive coronary atherosclerosis in patients undergoing mitral valve prolapse operations. This model can identify low-risk patients in whom routine preoperative angiography may be safely avoided.

  5. Prediction of coronary artery disease in patients undergoing operations for mitral valve degeneration

    Science.gov (United States)

    Lin, S. S.; Lauer, M. S.; Asher, C. R.; Cosgrove, D. M.; Blackstone, E.; Thomas, J. D.; Garcia, M. J.

    2001-01-01

    OBJECTIVES: We sought to develop and validate a model that estimates the risk of obstructive coronary artery disease in patients undergoing operations for mitral valve degeneration and to demonstrate its potential clinical utility. METHODS: A total of 722 patients (67% men; age, 61 +/- 12 years) without a history of myocardial infarction, ischemic electrocardiographic changes, or angina who underwent routine coronary angiography before mitral valve prolapse operations between 1989 and 1996 were analyzed. A bootstrap-validated logistic regression model on the basis of clinical risk factors was developed to identify low-risk (disease include age, male sex, hypertension, diabetes mellitus,and hyperlipidemia. Two hundred twenty patients were designated as low risk according to the logistic model. Of these patients, only 3 (1.3%) had single-vessel disease, and none had multivessel disease. The model showed good discrimination, with an area under the receiver-operating characteristic curve of 0.84. Cost analysis indicated that application of this model could safely eliminate 30% of coronary angiograms, corresponding to cost savings of $430,000 per 1000 patients without missing any case of high-risk coronary artery disease. CONCLUSION: A model with standard clinical predictors can reliably estimate the prevalence of obstructive coronary atherosclerosis in patients undergoing mitral valve prolapse operations. This model can identify low-risk patients in whom routine preoperative angiography may be safely avoided.

  6. Computer-aided evaluation of low-dose and low-contrast agent third-generation dual-source CT angiography prior to transcatheter aortic valve implantation (TAVI).

    Science.gov (United States)

    Dankerl, Peter; Hammon, Matthias; Seuss, Hannes; Tröbs, Monique; Schuhbaeck, Annika; Hell, Michaela M; Cavallaro, Alexander; Achenbach, Stephan; Uder, Michael; Marwan, Mohamed

    2017-05-01

    To evaluate the performance of computer-aided evaluation software for a comprehensive workup of patients prior to transcatheter aortic valve implantation (TAVI) using low-contrast agent and low radiation dose third-generation dual-source CT angiography. We evaluated 30 consecutive patients scheduled for TAVI. All patients underwent ECG-triggered high-pitch dual-source CT angiography of the aortic root and aorta with a standardized contrast agent volume (30 ml Imeron350, flow rate 4 ml/s) and low-dose (100 kv/350 mAs) protocol. An expert (10 years of experience) manually evaluated aortic root and iliac access dimensions (distance between coronary ostia and aortic annulus, minimal/maximal diameters and area-derived diameter of the aortic annulus) and best CT-predicted fluoroscopic projection angle as the reference standard. Utilizing computer-aided software (syngo.via), the same pre-TAVI workup was performed and compared to the reference standard. Mean CTDI[Formula: see text] was 3.46 mGy and mean DLP 217.6 ± 12.1 mGy cm, corresponding to a mean effective dose of 3.7 ± 0.2 mSv. Computer-aided evaluation was successful in all but one patient. Compared to the reference standard, Bland-Altman analysis indicated very good agreement for the distances between aortic annulus and coronary ostia (RCA: mean difference 0.8 mm; 95 % CI 0.4-1.2 mm; LM: mean difference 0.9 mm; 95 % CI 0.5-1.3 mm); however, we demonstrated a systematic overestimation of annulus- derived diameter using the software (mean difference 44.4 mm[Formula: see text]; 95 % CI 30.4-58.3 mm[Formula: see text]). Based on respective annulus dimensions, the recommended prosthesis size (Edwards SAPIEN 3) matched in 26 out of the 29 patients (90 %). CT-derived fluoroscopic projection angles showed an excellent agreement for both methods. Out of 58 iliac arteries, 15 (25 %) arteries could not be segmented by the software. Preprocessing time of the software was 71 ± 11 s (range 51-96

  7. Comparison in Men Versus Women of Co-morbidities, Complications, and Outcomes After Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis.

    Science.gov (United States)

    Gaglia, Michael A; Lipinski, Michael J; Torguson, Rebecca; Gai, Jiaxiang; Ben-Dor, Itsik; Bernardo, Nelson L; Satler, Lowell F; Pichard, Augusto D; Waksman, Ron

    2016-12-01

    Transcatheter aortic valve implantation (TAVI) decreases mortality in high-risk patients with severe aortic stenosis, but it remains unclear if female gender is associated with more favorable outcomes after TAVI. All patients who underwent TAVI at a single institution were retrospectively analyzed and stratified by gender. Procedural, in-hospital, 30-day, and 1-year outcomes were defined according to the second Valve Academic Research Consortium. The primary end point was all-cause mortality at 1 year. Kaplan-Meier survival analysis and multivariable Cox proportional hazards regression were conducted. Overall, 755 patients underwent TAVI and were included in the study; 50.7% were women. Average age was 83.0 ± 7.7 years, with a mean Society of Thoracic Surgeons score of 8.9 ± 4.6. Women were older than men and more likely to be black. Most co-morbidities were less common among women, and they were more likely than men to suffer both in-hospital (8.4% vs 4.3%, p = 0.021) and 30-day (9.4% vs 5.4%, p = 0.035) all-cause mortality. Life-threatening bleeding, transfusion, and iliofemoral dissection or perforation were more common among women. There was no difference in mortality between women and men at 1 year (20.6% vs 21.5%, log-rank p = 0.87). After multivariable adjustment, however, female gender was independently associated with lower mortality at 1 year after TAVI. In conclusion, despite higher rates of major bleeding, vascular complications, and 30-day mortality, female gender was independently associated with improved survival at 1 year after TAVI. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Use of data mining to predict significant factors and benefits of bilateral cochlear implantation.

    Science.gov (United States)

    Ramos-Miguel, Angel; Perez-Zaballos, Teresa; Perez, Daniel; Falconb, Juan Carlos; Ramosb, Angel

    2015-11-01

    Data mining (DM) is a technique used to discover pattern and knowledge from a big amount of data. It uses artificial intelligence, automatic learning, statistics, databases, etc. In this study, DM was successfully used as a predictive tool to assess disyllabic speech test performance in bilateral implanted patients with a success rate above 90%. 60 bilateral sequentially implanted adult patients were included in the study. The DM algorithms developed found correlations between unilateral medical records and Audiological test results and bilateral performance by establishing relevant variables based on two DM techniques: the classifier and the estimation. The nearest neighbor algorithm was implemented in the first case, and the linear regression in the second. The results showed that patients with unilateral disyllabic test results below 70% benefited the most from a bilateral implantation. Finally, it was observed that its benefits decrease as the inter-implant time increases.

  9. Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants.

    Science.gov (United States)

    Koertke, Heinrich; Zittermann, Armin; Wagner, Otto; Secer, Songuel; Sciangula, Alfonso; Saggau, Werner; Sack, Falk-Udo; Ennker, Jürgen; Cremer, Jochen; Musumeci, Francesco; Gummert, Jan F

    2015-06-01

    To study in patients performing international normalized ratio (INR) self-control the efficacy and safety of an INR target range of 1.6-2.1 for aortic valve replacement (AVR) and 2.0-2.5 for mitral valve replacement (MVR) or double valve replacement (DVR). In total, 1304 patients undergoing AVR, 189 undergoing MVR and 78 undergoing DVR were randomly assigned to low-dose INR self-control (LOW group) (INR target range, AVR: 1.8-2.8; MVR/DVR: 2.5-3.5) or very low-dose INR self-control once a week (VLO group) and twice a week (VLT group) (INR target range, AVR: 1.6-2.1; MVR/DVR: 2.0-2.5), with electronically guided transfer of INR values. We compared grade III complications (major bleeding and thrombotic events; primary end-points) and overall mortality (secondary end-point) across the three treatment groups. Two-year freedom from bleedings in the LOW, VLO, and VLT groups was 96.3, 98.6, and 99.1%, respectively (P = 0.008). The corresponding values for thrombotic events were 99.0, 99.8, and 98.9%, respectively (P = 0.258). The risk-adjusted composite of grade III complications was in the per-protocol population (reference: LOW-dose group) as follows: hazard ratio = 0.307 (95% CI: 0.102-0.926; P = 0.036) for the VLO group and = 0.241 (95% CI: 0.070-0.836; P = 0.025) for the VLT group. The corresponding values of 2-year mortality were = 1.685 (95% CI: 0.473-5.996; P = 0.421) for the VLO group and = 4.70 (95% CI: 1.62-13.60; P = 0.004) for the VLT group. Telemedicine-guided very low-dose INR self-control is comparable with low-dose INR in thrombotic risk, and is superior in bleeding risk. Weekly testing is sufficient. Given the small number of MVR and DVR patients, results are only valid for AVR patients. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  10. Efficacy and safety of intravitreal ranibizumab with panretinal photocoagulation followed by trabeculectomy compared with Ahmed glaucoma valve implantation in neovascular glaucoma

    Directory of Open Access Journals (Sweden)

    Jin-Tao Sun

    2017-03-01

    Full Text Available AIM: To evaluate the efficacy and safety of intravitreal ranibizumab (IVR with panretinal photocoagulation (PRP followed by trabeculectomy compared with Ahmed glaucoma valve (AGV implantation in neovascular glaucoma (NVG. METHODS: This was a retrospective comparative study. We reviewed the cases of a total of 45 eyes from 45 NVG patients among which 23 eyes underwent AGV implantation and the other 22 underwent trabeculectomy. The causes of neovascular glaucoma included: diabetic retinopathy (25 eyes, and retinal vein occlusion (20 eyes. All patients received preoperative IVR combined with postoperative PRP. The mean best-corrected visual acuities (BCVA were converted to the logarithms of the minimum angle of resolution (logMAR for the statisitical analyses. Intraocular pressure (IOP, the logMAR BCVA and surgical complications were evaluated before and after surgery. The follow-up period was 12mo. RESULTS: A total of 39 cases showed complete regression of iris neovascularization at 7d after injection, and 6 cases showed a small amount of residual iris neovascularization. The success rates were 81.8% and 82.6% at 12mo after trabeculectomy and AGV implantation, respectively. In the trabeculectomy group, the logMAR BCVA improved at the last follow-up in 14 eyes, remained stable in 6 eyes and decreased in 2 eyes. In 4 cases, slight hyphemas developed after trabeculectomy. A shallow anterior chamber developed in 2 cases and 2 vitreous hemorrhages. In the AGV group, the logMAR BCVA improved in 14 eyes, remained stable in 5 eyes and decreased in 4 eyes. Slight hyphemas developed in 3 cases, and a shallow anterior chamber in 3 cases. The mean postoperative IOP was significantly lower in both groups after surgery (F=545.468, P<0.05, and the mean postoperative logMAR BCVA was also significantly improved (F=10.964, P<0.05 with no significant difference between two groups. CONCLUSION: It is safe and effective to treat NVG with this combined procedure, and we

  11. Use of Intraoral Welding to Increase the Predictability of Immediately Loaded Computer-Guided Implants.

    Science.gov (United States)

    Albiero, Alberto Maria; Benato, Renato; Benato, Andrea; Degidi, Marco

    Inaccuracy of computer-guided implant placement may lead to complications when combined with an immediately loaded prefabricated prosthesis. The aim of this case series was to describe the use of an intraoral welding technique to increase the predictability of immediately loaded implants supporting a fixed full-arch prosthesis after computer-guided flapless implant placement. A total of 60 Ankylos plus implants (Dentsply) with a width of 3.5 mm and a length of 8 to 14 mm were placed consecutively in 10 patients. The implants were functionally loaded using the intraoral welding technique on the day of surgery. The accuracy of guided implant placement was assessed by matching the planning cone beam computed tomography (CBCT) scans with postoperative CBCT scans. No mechanical or biologic complications were registered at the 1-year follow-up. The global coronal deviation of implant placement from the guide plan ranged from 0.25 to 2.84 mm (SD: 0.6 mm), with a mean of 1.28 mm. Average angle deviation was 3.42 degrees (range 0.38-7.82 degrees; SD: 1.52 degrees). The global apical deviation ranged between 0.36 and 3.85 mm (SD: 0.71 mm), with a mean of 1.65 mm. Despite the inaccuracy registered, this guided-welded approach allowed successful achievement of a passive fit of the full-arch prosthesis on the inserted implants the same day of the surgery and provided a high implant and prosthetic survival rate at the 1-year follow-up.

  12. Prediction of coronary artery disease in patients undergoing operations for mitral valve degeneration

    Science.gov (United States)

    Lin, S. S.; Lauer, M. S.; Asher, C. R.; Cosgrove, D. M.; Blackstone, E.; Thomas, J. D.; Garcia, M. J.

    2001-01-01

    OBJECTIVES: We sought to develop and validate a model that estimates the risk of obstructive coronary artery disease in patients undergoing operations for mitral valve degeneration and to demonstrate its potential clinical utility. METHODS: A total of 722 patients (67% men; age, 61 +/- 12 years) without a history of myocardial infarction, ischemic electrocardiographic changes, or angina who underwent routine coronary angiography before mitral valve prolapse operations between 1989 and 1996 were analyzed. A bootstrap-validated logistic regression model on the basis of clinical risk factors was developed to identify low-risk (coronary atherosclerosis was defined as 50% or more luminal narrowing in one or more major epicardial vessels, as determined by means of coronary angiography. RESULTS: One hundred thirty-nine (19%) patients had obstructive coronary atherosclerosis. Independent predictors of coronary artery disease include age, male sex, hypertension, diabetes mellitus,and hyperlipidemia. Two hundred twenty patients were designated as low risk according to the logistic model. Of these patients, only 3 (1.3%) had single-vessel disease, and none had multivessel disease. The model showed good discrimination, with an area under the receiver-operating characteristic curve of 0.84. Cost analysis indicated that application of this model could safely eliminate 30% of coronary angiograms, corresponding to cost savings of $430,000 per 1000 patients without missing any case of high-risk coronary artery disease. CONCLUSION: A model with standard clinical predictors can reliably estimate the prevalence of obstructive coronary atherosclerosis in patients undergoing mitral valve prolapse operations. This model can identify low-risk patients in whom routine preoperative angiography may be safely avoided.

  13. Sensitivity and specificity of radiographic methods for predicting insertion torque of dental implants.

    Science.gov (United States)

    Cortes, Arthur Rodriguez Gonzalez; Eimar, Hazem; Barbosa, Jorge de Sá; Costa, Claudio; Arita, Emiko Saito; Tamimi, Faleh

    2015-05-01

    Subjective radiographic classifications of alveolar bone have been proposed and correlated with implant insertion torque (IT). The present diagnostic study aims to identify quantitative bone features influencing IT and to use these findings to develop an objective radiographic classification for predicting IT. Demographics, panoramic radiographs (taken at the beginning of dental treatment), and cone-beam computed tomographic scans (taken for implant surgical planning) of 25 patients receiving 31 implants were analyzed. Bone samples retrieved from implant sites were assessed with dual x-ray absorptiometry, microcomputed tomography, and histology. Odds ratio, sensitivity, and specificity of all variables to predict high peak IT were assessed. A ridge cortical thickness >0.75 mm and a normal appearance of the inferior mandibular cortex were the most sensitive variables for predicting high peak IT (87.5% and 75%, respectively). A classification based on the combination of both variables presented high sensitivity (90.9%) and specificity (100%) for predicting IT. Within the limitations of this study, the results suggest that it is possible to predict IT accurately based on radiographic findings of the patient. This could be useful in the treatment plan of immediate loading cases.

  14. Can routine office-based audiometry predict cochlear implant evaluation results?

    Science.gov (United States)

    Gubbels, Samuel P; Gartrell, Brian C; Ploch, Jennifer L; Hanson, Kevin D

    2017-01-01

    Determining cochlear implant candidacy requires a specific sentence-level testing paradigm in best-aided conditions. Our objective was to determine if findings on routine audiometry could predict the results of a formal cochlear implant candidacy evaluation. We hypothesize that findings on routine audiometry will accurately predict cochlear implant evaluation results in the majority of candidates. Retrospective, observational, diagnostic study. The charts of all adult patients who were evaluated for implant candidacy at a tertiary care center from June 2008 through June 2013 were included. Routine, unaided audiologic measures (pure-tone hearing thresholds and recorded monosyllabic word recognition testing) were then correlated with best-aided sentence-level discrimination testing (using either the Hearing in Noise Test or AzBio sentences test). The degree of hearing loss at 250 to 4,000 Hz and monosyllabic word recognition scores significantly correlated with sentence-level word discrimination test results. Extrapolating from this association, we found that 86% of patients with monosyllabic word recognition scores at or below 32% (or 44% for patients with private insurance) would meet candidacy requirements for cochlear implantation. Routine audiometric findings can be used to identify patients who are likely to meet cochlear implant candidacy upon formal testing. For example, patients with pure-tone thresholds (250, 500, 1,000 Hz) of ≥75 dB and/or a monosyllabic word recognition test score of ≤40% have a high likelihood of meeting candidacy criteria. Utilization of these predictive patterns during routine audiometric evaluation may assist hearing health professionals in deciding when to refer patients for a formal cochlear implant evaluation. 4 Laryngoscope, 127:216-222, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  15. Numerical Predictions of Flow Characteristics in a 90 Degree Bended Upward Elbow Located at the Downstream Region of a Flow Control Valve (Butterfly Valve)

    Energy Technology Data Exchange (ETDEWEB)

    Won, Se Youl; Park, Young Sheop; Kim, Yun Jung; Oh, Seung Jong [Korea Hydro and Nuclear Power Co. Ltd., Taejon (Korea, Republic of)

    2006-07-01

    Butterfly valves are widely used in industrial piping components. They are used for flow control in large diameter pipes because of their lightweight, simple structure and the rapidity of manipulation. Any flow disturbing components such as elbows, orifice plates and tees are recommended to be located in a distance of 8 diameters (L/D.8) from the downstream of butterfly valves to decrease the effect of flow disturbance. However, one would encounter cases where other piping components are installed in a close proximity due to the space restriction. In these cases, the numerical simulation will be useful to evaluate the impact of flow disturbances. In this study, we have examined one practical case encountered where the elbow is located in a close proximity to the butterfly valve. Due to the close proximity, we are concerned about pipe thinning and we use the numerical evaluation to determine the range of operating regime and options.

  16. Can quantity of amniotic fluid reliably predict postnatal renal function in boys with posterior urethral valves: a decision curve analysis.

    Science.gov (United States)

    Harper, Luke; Waubant, Alice; Vignes, Julien; Amat, Sara; Dobremez, Eric; Lefevre, Yan; Ferdynus, Cyril

    2017-09-01

    Prenatal management of male fetuses with suspected posterior urethral valves depends on reliable markers for postnatal long-term renal function. Whether ultrasound parameters, including the presence or absence of oligohydramnios, are reliable remains the subject of debate. We decided to evaluate the reliability of quantity of amniotic fluid to predict postnatal renal function using decision curve analysis (DCA), a method for evaluating the clinical utility of a diagnostic test. We analyzed retrospectively 51 male fetuses born with prenatally suspected posterior urethral valves between 2009 and 2012. We studied the relationship between quantity of amniotic fluid on prenatal ultrasound and the nadir creatinine during the first year of life as a proxy of postnatal renal function using DCA. Twelve fetuses presented with prenatal oligohydramnios. Thirty-one children had a normal nadir creatinine, of which one had prenatal oligohydramnios (3.2%). Thirteen had a nadir creatinine between 35 and 75 μmol/L, of which four had prenatal oligohydramnios (30.8%). Seven had a nadir creatinine >75 μmol/L, all of them had prenatal oligohydramnios. In this retrospective study, DCA confirms the relationship between prenatal quantity of amniotic fluid volume and postnatal renal function. © 2017 John Wiley & Sons, Ltd. © 2017 John Wiley & Sons, Ltd.

  17. Tricuspid valve and percutaneous approach: No longer the forgotten valve!

    Science.gov (United States)

    Bouleti, Claire; Juliard, Jean-Michel; Himbert, Dominique; Iung, Bernard; Brochet, Eric; Urena, Marina; Dilly, Marie-Pierre; Ou, Phalla; Nataf, Patrick; Vahanian, Alec

    2016-01-01

    Tricuspid valve disease is mainly represented by tricuspid regurgitation (TR), which is a predictor of poor outcome. TR is usually secondary, caused by right ventricle pressure or volume overload, the leading cause being left-sided heart valve diseases. Tricuspid surgery for severe TR is recommended during left valve surgery, and consists of either a valve replacement or, most often, a tricuspid repair with or without prosthetic annuloplasty. When TR persists or worsens after left valvular surgery, redo isolated tricuspid surgery is associated with high mortality. In addition, a sizeable proportion of patients present with tricuspid surgery deterioration over time, and need a reintervention, which is associated with high morbi-mortality rates. In this context, and given the recent major breakthrough in the percutaneous treatment of aortic and mitral valve diseases, the tricuspid valve appears an appealing challenge, although it raises specific issues. The first applications of transcatheter techniques for tricuspid valve disease were valve-in-valve and valve-in-ring implantation for degenerated bioprosthesis or ring annuloplasty. Some concerns remain regarding prosthesis sizing, rapid ventricular pacing and the best approach, but these procedures appear to be safe and effective. More recently, bicuspidization using a transcatheter approach for the treatment of native tricuspid valve has been published, in two patients. Finally, other devices are in preclinical development. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  18. In situ heart valve tissue engineering using a bioresorbable elastomeric implant - From material design to 12 months follow-up in sheep

    NARCIS (Netherlands)

    Kluin, Jolanda; Talacua, Hanna; Smits, Anthal I P M; Emmert, Maximilian Y; Brugmans, Marieke C P; Fioretta, Emanuela S; Dijkman, Petra E; Söntjens, Serge H M; Duijvelshoff, Renée; Dekker, Sylvia; Janssen-van den Broek, Marloes W J T; Lintas, Valentina; Vink, Aryan; Hoerstrup, Simon P; Janssen, Henk M; Dankers, Patricia Y W; Baaijens, Frank P T; Bouten, Carlijn V C

    2017-01-01

    The creation of a living heart valve is a much-wanted alternative for current valve prostheses that suffer from limited durability and thromboembolic complications. Current strategies to create such valves, however, require the use of cells for in vitro culture, or decellularized human- or

  19. Impact of aortic root geometry on hydrody-namic performance of transcatheter aortic valve prostheses

    Directory of Open Access Journals (Sweden)

    Kaule Sebastian

    2017-09-01

    Full Text Available Assessment of hydrodynamic performance of transcatheter aortic valve prostheses (TAVP in vitro is es-sentially in the fields of development and approval of novel implants. For the prediction of clinical performance, in vitro testing of TAVP allows for benchmarking of different devic-es, likewise. In addition to the implant itself, also the testing environment has a crucial influence on leaflet dynamics and quantitative test results like effective orifice area (EOA or aortic regurgitation.

  20. Predictable dental rehabilitation in maxillomandibular reconstruction with free flaps. The role of implant guided surgery.

    Science.gov (United States)

    Cebrian-Carretero, José-Luis; Guiñales-Díaz de Cevallos, Jorge; Sobrino, José-Andrés; Yu, Tomás; Burgueño-García, Miguel

    2014-11-01

    The reconstruction of maxillomandibular defects secondary to oral cancer surgery, represent a great challenge for Maxillofacial surgeons. During the last decades the reconstructive surgery has experimented a big advance due to the development of the microsurgical techniques. At present, we are able to reconstruct complex defects using free flaps that provide both soft and bone tissue. Fibula, iliac crest and scapula free flaps have been the three classic options for the maxillomandibular reconstruction owing to the amount of bone that this flaps provide, allowing the posterior dental rehabilitation with implants. Today, our objective it is not only the aesthetic reconstruction, but also the functional reconstruction of the patients enhancing their life quality. Guided implant surgery in free flap reconstructed patients has become an essential tool, helping to define the exact position of the dental implant in the flap. In this way it is possible to look for the areas with better bone conditions, avoiding the osteosynthesis material used to fixate the flap with the native bone and deciding the best biomechanical option, in terms of number and situation of the implants, for the future dental prostheses. In summary, using the guided implant surgery, it is possible to design an exact and predictable dental implant rehabilitation in patients with oral cancer who are reconstructed with free microvascular flap, resulting in an optimal aesthetic and functional result.

  1. Profiles of Verbal Working Memory Growth Predict Speech and Language Development in Children with Cochlear Implants

    Science.gov (United States)

    Kronenberger, William G.; Pisoni, David B.; Harris, Michael S.; Hoen, Helena M.; Xu, Huiping; Miyamoto, Richard T.

    2013-01-01

    Purpose: Verbal short-term memory (STM) and working memory (WM) skills predict speech and language outcomes in children with cochlear implants (CIs) even after conventional demographic, device, and medical factors are taken into account. However, prior research has focused on single end point outcomes as opposed to the longitudinal process of…

  2. Manejo anestésico e complicações no implante percutâneo de válvula aórtica Manejo anestésico y complicaciones en el implante percutáneo de válvula aórtica Anesthetic management and complications of percutaneous aortic valve implantation

    Directory of Open Access Journals (Sweden)

    Tailur Alberto Grando

    2013-06-01

    Full Text Available JUSTIFICATIVA E OBJETIVOS: A estenose aórtica (EA grave é uma doença prevalente e de grande mortalidade. Nos pacientes idosos com outras comorbidades o implante valvar percutâneo é uma opção. OBJETIVOS: Descrever o manejo anestésico e as complicações com anestesia geral. MÉTODO: Série de casos com seguimento de 30 dias e 24 meses após o implante do dispositivo CoreValve feito no Instituto de Cardiologia/Fundação Universitária de Cardiologia entre dezembro de 2008 e janeiro de 2012. Os pacientes foram submetidos à anestesia geral monitorada com pressão arterial média (PAM, eletrocardiograma (ECG, oximetria, capnografia, ecocardiograma transesofágico, termometria e marcapasso transvenoso. RESULTADOS: Foram submetidos com sucesso ao implante valvular 28 pacientes, com idade média de 82,46 anos, EuroScore médio de 20,98%, classe funcional III/IV. Nove pacientes necessitaram de implante de marcapasso definitivo. No seguimento dos pacientes houve dois óbitos, um no transoperatório por perfuração do VE e um no terceiro dia por causa desconhecida. Em 24 meses um paciente faleceu com diagnóstico de mieloma múltiplo. A técnica anestésica mostrou-se segura. CONCLUSÃO: A experiência inicial com implante valvular aórtico percutâneo sob anestesia geral tem se mostrado segura e eficaz sem complicações anestésicas importantes para esse procedimento.JUSTIFICATIVA Y OBJETIVOS: La estenosis aórtica (EA grave es una enfermedad prevalente y de gran mortalidad. En los pacientes ancianos con otras comorbilidades, el implante valvular percutáneo es una opción. OBJETIVOS: Describir el manejo anestésico y las complicaciones con la anestesia general. MÉTODO: Serie de casos con seguimiento de 30 días y 24 meses después del implante del dispositivo CoreValve hecho en el Instituto de Cardiología/Fundación Universitaria de Cardiología entre diciembre de 2008 y enero de 2012. Los pacientes fueron sometidos a la anestesia general

  3. SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation.

    Science.gov (United States)

    Stabile, Eugenio; Pucciarelli, Armando; Cota, Linda; Sorropago, Giovanni; Tesorio, Tullio; Salemme, Luigi; Popusoi, Grigore; Ambrosini, Vittorio; Cioppa, Angelo; Agrusta, Marco; Catapano, Donato; Moscariello, Cesare; Trimarco, Bruno; Esposito, Giovanni; Rubino, Paolo

    2014-07-01

    Common clinical practice recommends dual antiplatelet therapy (DAPT) for transcatheter aortic valve implantation (TAVI). The aim of the study was to evaluate, in a double blind randomized study, the safety of TAVI, with adjunctive pharmacotherapy consisting of single antiplatelet therapy. From April 2010 to April 2011, 120 consecutive patients, undergoing TAVI, have been enrolled in the study. Patients were randomly assigned to DAPT group (aspirin and clopidogrel 75 mg/qd or ticlopidine 500 mg/bid) or ASA group (aspirin only). TAVI device was the Sapien XT-Novaflex Delivery System (Edwards Lifesciences, Inc.). All patients were followed up to 6 months. Device success was achieved in 100% of patients. No difference in the VARC combined 30 day safety endpoint, all cause and cardiovascular mortality was observed. At 30 days vascular complications were reduced in the ASA group (p<0.05). No differences in the clinical status were detected between the groups up to 6 months. This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality. These findings, if confirmed in a larger multicenter randomized trial, will no longer support the use of DAPT for TAVI. Copyright © 2014. Published by Elsevier Ireland Ltd.

  4. Contrast volume reduction using third generation dual source computed tomography for the evaluation of patients prior to transcatheter aortic valve implantation

    Energy Technology Data Exchange (ETDEWEB)

    Bittner, Daniel O. [University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg (FAU), Department of Internal Medicine 2 (Cardiology), Erlangen (Germany); Harvard Medical School, Cardiac MR PET CT Program, Massachusetts General Hospital, Boston, MA (United States); Arnold, Martin; Klinghammer, Lutz; Schuhbaeck, Annika; Hell, Michaela M.; Muschiol, Gerd; Gauss, Soeren; Achenbach, Stephan; Marwan, Mohamed [University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg (FAU), Department of Internal Medicine 2 (Cardiology), Erlangen (Germany); Lell, Michael; Uder, Michael [University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nuernberg (FAU), Department of Radiology, Erlangen (Germany); Hoffmann, Udo [Harvard Medical School, Cardiac MR PET CT Program, Massachusetts General Hospital, Boston, MA (United States)

    2016-12-15

    Chronic renal failure is common in patients referred for transcatheter aortic valve implantation (TAVI). CT angiography is recommended and provides crucial information prior to TAVI. We evaluated the feasibility of a reduced contrast volume protocol for pre-procedural CT imaging. Forty consecutive patients were examined with prospectively ECG-triggered high-pitch spiral acquisition using a novel third-generation dual-source CT system; 38 ml contrast agent was used. Image quality was graded on a visual scale (1-4). Contrast attenuation was measured at the level of the aortic root and at the iliac bifurcation. Mean patient age was 82 ± 6 years (23 males; 58 %). Mean attenuation/average image quality was 285 ± 60 HU/1.5 at the aortic annulus compared to 289 ± 74 HU/1.8 at the iliac bifurcation (p = 0.77/p = 0.29). Mean estimated effective radiation dose was 2.9 ± 0.3 mSv. A repeat acquisition was necessary in one patient due to image quality. Out of the 35 patients who underwent TAVI, 31 (89 %) patients had no or mild aortic regurgitation. Thirty-two (91 %) patients were discharged successfully. Pre-procedural CTA with a total of 38 ml contrast volume is feasible and clinically useful, using third-generation dual-source CT, allowing comprehensive imaging for procedural success. (orig.)

  5. Low Magnesium Levels and FGF-23 Dysregulation Predict Mitral Valve Calcification as well as Intima Media Thickness in Predialysis Diabetic Patients

    Directory of Open Access Journals (Sweden)

    Ana Paula Silva

    2015-01-01

    Full Text Available Background. Mitral valve calcification and intima media thickness (IMT are common complications of chronic kidney disease (CKD implicated with high cardiovascular mortality. Objective. To investigate the implication of magnesium and fibroblast growth factor-23 (FGF-23 levels with mitral valve calcification and IMT in CKD diabetic patients. Methods. Observational, prospective study involving 150 diabetic patients with mild to moderate CKD, divided according to Wilkins Score. Carotid-echodoppler and transthoracic echocardiography were used to assess calcification. Statistical tests used to establish comparisons between groups, to identify risk factors, and to establish cut-off points for prediction of mitral valve calcification. Results. FGF-23 values continually increased with higher values for both IMT and calcification whereas the opposite trend was observed for magnesium. FGF-23 and magnesium were found to independently predict mitral valve calcification and IMT (P<0.05. Using Kaplan-Meier analysis, the number of deaths was higher in patients with lower magnesium levels and poorer Wilkins score. The mean cut-off value for FGF-23 was 117 RU/mL and for magnesium 1.7 mg/dL. Conclusions. Hypomagnesemia and high FGF-23 levels are independent predictors of mitral valve calcification and IMT and are risk factors for cardiovascular mortality in this population. They might be used as diagnostic/therapeutic targets in order to better manage the high cardiovascular risk in CKD patients.

  6. Valve Disease

    Science.gov (United States)

    ... See also on this site: Diseases of the Mitral Valve Diseases of the Aortic Valve Diseases of the Tricuspid ... most invasive option for the treatment of valve disease. During surgery, ... defects of the mitral valve. Replacement is used to treat any diseased ...

  7. Prediction of extracellular matrix stiffness in engineered heart valve tissues based on nonwoven scaffolds.

    Science.gov (United States)

    Engelmayr, George C; Sacks, Michael S

    2008-08-01

    The in vitro development of tissue engineered heart valves (TEHV) exhibiting appropriate structural and mechanical characteristics remains a significant challenge. An important step yet to be addressed is establishing the relationship between scaffold and extracellular matrix (ECM) mechanical properties. In the present study, a composite beam model accounting for nonwoven scaffold-ECM coupling and the transmural collagen concentration distribution was developed, and utilized to retrospectively estimate the ECM effective stiffness in TEHV specimens incubated under static and cyclic flexure conditions (Engelmayr Jr et~al. in Biomaterials 26(2):175-187 2005). The ECM effective stiffness was expressed as the product of the local collagen concentration and the collagen specific stiffness (i.e., stiffness/concentration), and was related to the overall TEHV effective stiffness via an empirically determined scaffold-ECM coupling parameter and measured transmural collagen concentration distributions. The scaffold-ECM coupling parameter was determined by flexural mechanical testing of polyacrylamide gels (i.e., ECM analogs) of variable stiffness and associated scaffold-polyacrylamide gel composites (i.e., engineered tissue analogs). The transmural collagen concentration distributions were quantified from fluorescence micrographs of picro-sirius red stained TEHV sections. As suggested by a previous structural model of the nonwoven scaffold (Engelmayr Jr and Sacks in J Biomech Eng 128(4):610-622, 2006), nonwoven scaffold-ECM composites did not follow a traditional rule of mixtures. The present study provided further evidence that the primary mode of reinforcement in nonwoven scaffold-ECM composites is an increase in the number fiber-fiber bonds with a concomitant increase in the effective stiffness of the spring-like fiber segments. Simulations of potential ECM deposition scenarios using the current model indicated that the present approach is sensitive to the specific time

  8. Transapical JenaValve in a patient with mechanical mitral valve prosthesis.

    LENUS (Irish Health Repository)

    O' Sullivan, Katie E

    2014-01-29

    We report the first case of transcatheter aortic valve replacement implantation using JenaValve™ in a patient with mechanical mitral valve prosthesis. We believe that the design features of this valve may be particularly suited for use in this setting. © 2014 Wiley Periodicals, Inc.

  9. Maximizing prosthetic valve size with the Top Hat supra-annular aortic valve

    DEFF Research Database (Denmark)

    Aagaard, Jan; Geha, Alexander S.

    2007-01-01

    -annular mechanical prostheses (CarboMedics, Inc., Arvada, CO, USA) at two institutions. Size frequency distribution was compared to published series, and to the manufacturer's US registry. The ventriculoaortic junction (VAJ) size was available in 234 patients, and compared to the size of the Top Hat valve implanted......BACKGROUND AND AIM OF THE STUDY: The CarboMedics Top Hat supra-annular aortic valve allows a one-size (and often two-size) increase over the standard intra-annular valve. This advantage should minimize the risk of patient-prosthesis mismatch, where the effective prosthetic valve orifice area...... is less than that of a normal valve. It is suggested that the ability to implant Top Hat valves having greater size, relative to standard intra-annular valves, may currently be under-utilized. Further, there has been some concern that Top Hat implantation can cause obstruction of the coronary ostia...

  10. Fluid–Structure Interaction Analysis of Papillary Muscle Forces Using a Comprehensive Mitral Valve Model with 3D Chordal Structure

    Energy Technology Data Exchange (ETDEWEB)

    Toma, Milan; Jensen, Morten Ø.; Einstein, Daniel R.; Yoganathan, Ajit P.; Cochran, Richard P.; Kunzelman, Karyn S.

    2015-07-17

    Numerical models of native heart valves are being used to study valve biomechanics to aid design and development of repair procedures and replacement devices. These models have evolved from simple two-dimensional approximations to complex three-dimensional, fully coupled fluid-structure interaction (FSI) systems. Such simulations are useful for predicting the mechanical and hemodynamic loading on implanted valve devices. A current challenge for improving the accuracy of these predictions is choosing and implementing modeling boundary conditions. In order to address this challenge, we are utilizing an advanced in-vitro system to validate FSI conditions for the mitral valve system. Explanted ovine mitral valves were mounted in an in vitro setup, and structural data for the mitral valve was acquired with *CT. Experimental data from the in-vitro ovine mitral valve system were used to validate the computational model. As the valve closes, the hemodynamic data, high speed lea et dynamics, and force vectors from the in-vitro system were compared to the results of the FSI simulation computational model. The total force of 2.6 N per papillary muscle is matched by the computational model. In vitro and in vivo force measurements are important in validating and adjusting material parameters in computational models. The simulations can then be used to answer questions that are otherwise not possible to investigate experimentally. This work is important to maximize the validity of computational models of not just the mitral valve, but any biomechanical aspect using computational simulation in designing medical devices.

  11. Physical Activity Measured by Implanted Devices Predicts Atrial Arrhythmias and Patient Outcome: Results of IMPLANTED (Italian Multicentre Observational Registry on Patients With Implantable Devices Remotely Monitored).

    Science.gov (United States)

    Palmisano, Pietro; Guerra, Federico; Ammendola, Ernesto; Ziacchi, Matteo; Luigi Pisanò, Ennio Carmine; Dell'Era, Gabriele; Aspromonte, Vittorio; Zaccaria, Maria; Di Ubaldo, Francesco; Capucci, Alessandro; Nigro, Gerardo; Occhetta, Eraldo; Maglia, Giampiero; Ricci, Renato Pietro; Boriani, Giuseppe; Accogli, Michele

    2018-02-24

    To determine whether daily physical activity (PA), as measured by implanted devices (through accelerometer sensor), was related to the risk of developing atrial arrhythmias during long-term follow-up in a population of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD). The study population was divided into 2 equally sized groups (PA cutoff point: 3.5 h/d) according to their mean daily PA recorded by the device during the 30- to 60-day period post-ICD implantation. Propensity score matching was used to compare 2 equally sized cohorts with similar characteristics between lower and higher activity patients. The primary end point was time free from the first atrial high-rate episode (AHRE) of duration ≥6 minutes. Secondary end points were: first AHRE ≥6 hours, first AHRE ≥48 hours, and a combined end point of death or HF hospitalization. Data from 770 patients (65±15 years; 66% men; left ventricular ejection fraction 35±12%) remotely monitored for a median of 25 months were analyzed. A PA ≥3.5 h/d was associated with a 38% relative reduction in the risk of AHRE ≥6 minutes (72-month cumulative survival: 75.0% versus 68.1%; log rank P =0.025), and with a reduction in the risk of AHRE ≥6 hours, AHRE ≥48 hours, and the combined end point of death or HF hospitalization (all P <0.05). In HF patients with ICD, a low level of daily PA was associated with a higher risk of atrial arrhythmias, regardless of the patients' baseline characteristics. In addition, a lower daily PA predicted death or HF hospitalization. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  12. Edwards SAPIEN 3 valve.

    Science.gov (United States)

    Binder, Ronald K; Rodés-Cabau, Josep; Wood, David A; Webb, John G

    2012-09-01

    Building on the established success with the SAPIEN, SAPIEN XT and earlier prototypic transcatheter heart valves (THV) the newest balloon-expandable valve incorporates a number of new and enhanced features intended to reduce the risk of vascular injury, to reduce paravalvular regurgitation, and to facilitate rapid and accurate positioning and implantation. The SAPIEN 3 THV incorporates a cobalt chromium stent, bovine pericardial leaflets, and both an inner and new outer polyethylene terephthalate sealing cuff. The delivery system incorporates an active three-dimensional coaxial positioning catheter, and is compatible with a 14 Fr expandable sheath.

  13. Comparison of FP-7 and S-2 Ahmed glaucoma valve implantation in refractory glaucoma patients for short-term follow-up.

    Science.gov (United States)

    Bai, Yu-jing; Li, Yi-qing; Chai, Fang; Yang, Xue-jiao; Zhang, Yi-chong; Wei, Yan-tao; Huang, Jing-jing; Ge, Jian; Zhuo, Ye-hong

    2011-04-01

    Ahmed glaucoma valves (AGV) has been used for decades, but there is no detailed report about the efficacy of AGV in Chinese glaucoma patients. This study aimed to compare the intraocular pressure (IOP) lowering efficacy and side effects of S-2 polypropylene and PF-7 silicone AGV implantation in Chinese refractory glaucoma patients. Patients were divided into S-2 model AGV group and FP-7 model AGV group. The complete and qualified surgical success rate, change of IOP, number of anti-glaucoma medications used and postoperative complications were recorded and analyzed. Average follow-up time was comparable between two groups. IOP was reduced from (37.9 ± 12.7) mmHg preoperatively to (17.3 ± 5.3) mmHg at the last follow-up in S-2 group and reduced from (39.9 ± 14.4) mmHg to (17.7 ± 4.9) mmHg in FP-7 group. Anti-glaucoma medications were reduced from 3.8 ± 0.2 to 1.5 ± 0.2 in S-2 group, and 3.5 ± 0.2 to 0.7 ± 0.2 in FP-7 groups. The cumulative success rates were comparable in two groups, which were 61.2% and 72.1% in S-2 group and FP-7 group respectively. When IOP reduction criteria was used, complete success rates were 30.6% and 51.2% for S-2 and FP-7 groups, and qualified success rates were 86.1% and 92.7% separately. In both groups, the major complication was hypotony, and the previous trabeculectomy of patients was the major risk factor for surgery failure. In this short-term retrospective study, S-2 AGV is showed at least as effective as FP-7 AGV in IOP reduction, but associated with higher rate of complications. Previous trabeculectomy is a principle risk factor for AGV implantation failure. These clinical outcomes are important for converting use of the FP-7 silicon AGV in Chinese refractory glaucoma patients.

  14. Valve-in-valve outcome: design impact of a pre-existing bioprosthesis on the hydrodynamics of an Edwards Sapien XT valve.

    Science.gov (United States)

    Doose, Christian; Kütting, Maximilian; Egron, Sandrine; Farhadi Ghalati, Pejman; Schmitz, Christoph; Utzenrath, Marc; Sedaghat, Alexander; Fujita, Buntaro; Schmitz-Rode, Thomas; Ensminger, Stephan; Steinseifer, Ulrich

    2017-03-01

    Bioprosthetic aortic heart valves are increasingly implanted in younger patients. Therefore, a strategy for potential valve failure should be developed before implanting the 'first valve'. The goal of this in vitro study was to provide insight into the effects of the design of a bioprosthesis on a valve-in-valve implanted Sapien XT valve. The hydrodynamic performance of a 23-mm Sapien XT valve implanted in Vascutek Aspire, Edwards Perimount, Medtronic Mosaic and St. Jude Medical Trifecta heart valves was investigated in a left heart simulator. In addition to the hydrodynamic results, the leaflet dynamics were analysed in high-speed video recordings of the tests. All valve-in-valve combinations in this study fulfilled the minimum acceptance criteria defined by relevant approval standards (e.g. ISO 5840) but displayed significant differences in their performances. Small inner diameters of the bioprostheses were associated with increased mean pressure gradients, decreased effective orifice areas and geometric opening areas as well as with pin-wheeling and uneven leaflet motion. In addition, implantation in bioprostheses with internally mounted leaflets was associated with lower paravalvular leakage. The results of this study suggest that a surgical bioprosthesis with a large inner diameter and internally mounted leaflets improves the heamodynamics and potentially the durability of a valve-in-valve combination. These results should give the attending physicians critical information to consider when deciding on a bioprosthesis for younger patients.

  15. Impact of femoral artery puncture using digital subtraction angiography and road mapping on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation.

    Science.gov (United States)

    El-Mawardy, Mohamed; Schwarz, Bettina; Landt, Martin; Sulimov, Dmitriy; Kebernik, Julia; Allali, Abdelhakim; Becker, Bjoern; Toelg, Ralph; Richardt, Gert; Abdel-Wahab, Mohamed

    2017-01-20

    The use of large-diameter sheaths carries the risk of significant vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI). In this analysis, we sought to assess the impact of a modified femoral artery puncture technique using digital subtraction angiography (DSA) and road mapping during transfemoral TAVI on periprocedural vascular and bleeding events. This is a retrospective analysis of transfemoral TAVI patients included in a prospective institutional database. The modified femoral artery puncture technique using DSA-derived road mapping guidance was introduced in October 2012. Before the introduction of this technique, vascular puncture was acquired based on an integration of angiographic data, the bony iliofemoral landmarks and a radiopaque object. Consecutive patients who underwent TAVI with the road mapping technique (RM group, n=160) were compared with consecutive patients who underwent TAVI without road mapping (control group, n=160) prior to its introduction. A standardised strategy of periprocedural anticoagulation was adopted in both groups as well as the use of a single suture-based closure device. All endpoints were defined according to the VARC-2 criteria for event definition. The mean age in the RM group was 80±7.7 years compared to 81±5.9 years in the control group (p=0.19), and females were equally distributed between both groups (63.1% vs. 58.1%, p=0.36). The baseline logistic EuroSCORE was 20.7±14.4% vs. 24.9±15.2% in the RM and control group, respectively (p=0.01). Notably, sheath size was significantly larger in the RM compared to the control group due to the more frequent use of the 20 Fr sheath (23.8% vs. 1.8%, pstrategy for potentially improving patient outcomes.

  16. Improvement of quality of life following transcatheter aortic valve implantation in the elderly: a multi-centre study based on the Polish national TAVI registry.

    Science.gov (United States)

    Stańska, Aleksandra; Jagielak, Dariusz; Brzeziński, Maciej; Zembala, Michał; Wojakowski, Wojciech; Kochman, Janusz; Huczek, Zenon; Witkowski, Adam; Zembala, Marian

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) is an effective therapeutic method for elderly high-risk patients with symptomatic severe aortic stenosis, not eligible for surgical treatment. The aim of the study was to evaluate short-term changes in elderly people's quality of life following TAVI, based on the POL-TAVI registry. One hundred and eighty-four octogenarians' and nonagenarians' samples from the POL-TAVI database were included in the study. The quality of life status was assessed with EQ-5D-3L questionnaire at baseline and after one-month follow-up. The mean of patients' age was 84 (80-93) years. Logistic EuroSCORE mean was 19.83% (3.48-83.94%), and transaortic mean gradient was 54.99 (19.0-149.0) mm Hg. At baseline, up to 24.50% of patients declared severe problems in performing usual activities. 13.60% felt extreme pain or discomfort; 9.80% were unable to wash and dress by themselves; 8.20% were extremely anxious or depressed; and 7.10% of the patients in the study were confined to bed. After 30 days the percentage of patients declaring severe problems in each dimension did not exceed 4.00%. The comparison between quality of life data at baseline and after one-month follow-up showed a significant improvement in each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (p < 0.001). Patients' quality of life was increasing regardless of gender (female vs. male), the type of anaesthesia (general vs. local), and the type of procedure (TA vs. TF). Short-term quality of life in the elderly subjects was significantly improved after one-month follow-up following TAVI.

  17. Baseline characteristics and outcomes after transcatheter aortic-valve implantation in patients with or without previous balloon aortic valvuloplasty: Insights from the FRANCE 2 registry.

    Science.gov (United States)

    Bière, Loïc; Durfort, Amélie; Fouquet, Olivier; Hamel, Jean-François; Leprince, Pascal; Chevreul, Karine; Prat, Alain; Lievre, Michel; Donzeau-Gouge, Patrick; Fajadet, Jean; Teiger, Emmanuel; Eltchaninoff, Hélène; Iung, Bernard; Leguerrier, Alain; Gilard, Martine; Furber, Alain

    2017-10-01

    Some patients who are at high surgical risk because of multiple co-morbidities undergo balloon aortic valvuloplasty (BAV) as a bridge therapy towards transcatheter aortic-valve implantation (TAVI). The aim of this study was to compare the clinical course of patients with or without previous BAV who underwent TAVI and were included in the FRANCE 2 registry. From January 2010 to December 2011, 3953 patients underwent TAVI. Survival analysis was done by multivariable regression and propensity-score analysis to adjust for confounders. Patients in the previous BAV group (n=664, 16.8%) were older than patients in the primary TAVI group. The logistic EuroSCORE I and the rates of co-morbidities and symptoms were higher in the previous BAV group. Procedural success was similar in both groups, as was postprocedural aortic regurgitation grade≥2/4. The 1-month mortality rates from all causes were 12.5 and 8.7%, respectively, in the previous BAV and primary TAVI groups (P=0.001). The 1-month to 1-year mortality rates were similar in both groups. Previous BAV was not an independent predictor of 1-month mortality (hazard ratio 1.44, 95% confidence interval 0.90-2.34; P=0.14) or 1-month to 1-year mortality. Crude 1-month mortality was higher in patients with previous BAV. Nevertheless, precarious preoperative status, but not previous BAV, was associated with mortality, and is the only marker that should be considered as detrimental at the time of preTAVI reassessment. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  18. Intraocular pressure control and corneal graft survival after implantation of Ahmed valve device in high-risk penetrating keratoplasty.

    Science.gov (United States)

    Almousa, Radwan; Nanavaty, Mayank A; Daya, Sheraz M; Lake, Damian B

    2013-08-01

    To analyze the control of intraocular pressure (IOP) and corneal graft survival after implantation of Ahmed glaucoma device (AGD) in eyes that had high-risk penetrating keratoplasty (PK). This is a retrospective noncomparative case series of 59 eyes that had high-risk PK and underwent AGD insertion. The primary outcome measures are the control of IOP between 6 and 21 mm Hg and corneal graft survival. The secondary outcome measures are risk factors associated with IOP control and corneal graft survival. The mean IOP reduced significantly after the AGD procedure (26.45 ± 6.8 mm Hg preoperatively vs. 16.85 ± 7.4 mm Hg, 16.95 ± 4.6 mm Hg, 17.97 ± 5.7 mm Hg, 15.78 ± 5.2 mm Hg, and 15.59 ± 5.5 mm Hg, at 1 month, 6 months, 1 year, 2 years, and at the last follow-up postoperatively; P IOP control was successful in 44 eyes (75.8%). IOP control was successful in 96% of the eyes at 1 year, 87% at 2 years, 83% at 3 years, and 83% at 5 years. The percentage of clear corneal grafts after 1, 2, 3, and 5 years following the AGD insertion were 87%, 77%, 65%, and 47%, respectively. Further surgery after AGD insertion was associated with 1.79 times greater risk of failure of IOP control. AGD was effective in controlling the IOP associated with high-risk PK over a 5-year period. Postvalve surgery doubles the risk of failure of IOP control.

  19. A retrospective analysis of mitral valve pathology in the setting of bicuspid aortic valves

    Science.gov (United States)

    van Rensburg, Annari; Doubell, Anton

    2017-01-01

    The therapeutic implications of bicuspid aortic valve associations have come under scrutiny in the transcatheter aortic valve implantation era. We evaluate the spectrum of mitral valve disease in patients with bicuspid aortic valves to determine the need for closer echocardiographic scrutiny/follow-up of the mitral valve. A retrospective analysis of echocardiograms done at a referral hospital over five years was conducted in patients with bicuspid aortic valves with special attention to congenital abnormalities of the mitral valve. One hundred and forty patients with a bicuspid aortic valve were included. A congenital mitral valve abnormality was present in eight (5.7%, P = 0.01) with a parachute mitral valve in four (2.8%), an accessory mitral valve leaflet in one (0.7%), mitral valve prolapse in one, a cleft in one and the novel finding of a trileaflet mitral valve in one. Minor abnormalities included an elongated anterior mitral valve leaflet (P abnormal papillary muscles (P = 0.002) and an additional chord or tendon in the left ventricle cavity (P = 0.007). Mitral valve abnormalities occur more commonly in patients with bicuspid aortic valves than matched healthy individuals. The study confirms that abnormalities in these patients extend beyond the aorta. These abnormalities did not have a significant functional effect. PMID:28515127

  20. A retrospective analysis of mitral valve pathology in the setting of bicuspid aortic valves.

    Science.gov (United States)

    van Rensburg, Annari; Herbst, Philip; Doubell, Anton

    2017-06-01

    The therapeutic implications of bicuspid aortic valve associations have come under scrutiny in the transcatheter aortic valve implantation era. We evaluate the spectrum of mitral valve disease in patients with bicuspid aortic valves to determine the need for closer echocardiographic scrutiny/follow-up of the mitral valve. A retrospective analysis of echocardiograms done at a referral hospital over five years was conducted in patients with bicuspid aortic valves with special attention to congenital abnormalities of the mitral valve. One hundred and forty patients with a bicuspid aortic valve were included. A congenital mitral valve abnormality was present in eight (5.7%, P = 0.01) with a parachute mitral valve in four (2.8%), an accessory mitral valve leaflet in one (0.7%), mitral valve prolapse in one, a cleft in one and the novel finding of a trileaflet mitral valve in one. Minor abnormalities included an elongated anterior mitral valve leaflet (P mitral regurgitation (P Mitral valve abnormalities occur more commonly in patients with bicuspid aortic valves than matched healthy individuals. The study confirms that abnormalities in these patients extend beyond the aorta. These abnormalities did not have a significant functional effect. © 2017 The authors.

  1. Treatment of Aortic, Mitral and Tricuspid Structural Bioprosthetic Valve Deterioration Using the Valve-in-Valve Technique.

    Science.gov (United States)

    Codner, Pablo; Assali, Abid; Vaknin-Assa, Hana; Shapira, Yaron; Orvin, Katia; Sharony, Ram; Sagie, Alexander; Kornowski, Ran

    2015-05-01

    The percutaneous approach for a failed bioprosthetic valve is an emerging alternative to redo-valve surgery in patients at high surgical risk. The study aim was to describe the treatment of patients with structural bioprosthetic valve deterioration, using the valve-in-valve technique. A total of 33 consecutive patients with symptomatic structural bioprosthetic valve deterioration was treated at the authors' institution, using the valve-in-valve technique. The valve-in-valve procedure in the aortic position was performed in 23 patients (mean age 81.4 ± 5.9 years; mean STS score 9.6 ± 5.4). The self-expandable and balloon-expandable devices were used in 21 cases (91.3%) and two cases (8.7%), respectively. Procedures were performed via the trans-femoral, trans-axillary and trans-apical routes in 18 (78.2%), three (13%) and two (8.7%) cases, respectively. After the procedure, all patients were in NYHA class I/II. Survival rates were 95.6% at the one-year follow up. The valve-in-valve procedure in the mitral position was performed in 10 patients (mean age 73.6 ± 15 years; mean STS score 7.7 ± 4.1). All procedures were performed using the balloon-expandable device via the trans-apical route. The composite end point of device success was achieved in all patients. Survival rates were 100% and 75% at one month and two years' follow up, respectively. A single valve-in-valve implantation within a failed tricuspid bioprosthetic valve was also successfully performed. In the authors' experience, the valve-in-valve technique for the treatment of a wide range of bioprosthetic valve deterioration modes of failure in different valve positions is safe and very effective.

  2. A Risk Model for Prediction of 1-Year Mortality in Patients Undergoing MitraClip Implantation.

    Science.gov (United States)

    Buccheri, Sergio; Capodanno, Davide; Barbanti, Marco; Popolo Rubbio, Antonio; Di Salvo, Maria Elena; Scandura, Salvatore; Mangiafico, Sarah; Ronsivalle, Giuseppe; Chiarandà, Marta; Capranzano, Piera; Grasso, Carmelo; Tamburino, Corrado

    2017-05-01

    There is a lack of specific tools for risk stratification in patients who undergo MitraClip implantation. We aimed at combining preprocedural variables with prognostic impact into a specific risk model for the prediction of 1-year mortality in patients undergoing MitraClip implantation. A total of 311 consecutive patients who underwent MitraClip implantation were included. A lasso-penalized Cox-proportional hazard regression model was used to identify independent predictors of 1-year all-cause mortality. A nomogram (GRASP [Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation] nomogram) was obtained from the Cox model. Validation was performed using internal bootstrap resampling. Forty-two deaths occurred at 1-year follow-up. The Kaplan-Meier estimate of 1-year survival was 0.845 (95% confidence interval, 0.802 to 0.895). Four independent predictors of mortality (mean arterial blood pressure, hemoglobin natural log-transformed pro-brain natriuretic peptide levels, New York Heart Association class IV at presentation) were identified. At internal bootstrap resampling validation, the GRASP nomogram had good discrimination (area under receiver operating characteristic curve of 0.78, Somers' Dxy statistic of 0.53) and calibration (le Cessie-van Houwelingen-Copas-Hosmer p value of 0.780). Conversely, the discriminative ability of the EuroSCORE II (the European System for Cardiac Operative Risk Evaluation II) and the STS-PROM (the Society of Thoracic Surgeons Predicted Risk of Mortality score) was fairly modest with area under the curve values of 0.61 and 0.55, respectively. A treatment-specific risk model in patients who undergo MitraClip implantation may be useful for the stratification of mortality at 1 year. Further studies are needed to provide external validation and support the generalizability of the GRASP nomogram. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Patents and heart valve surgery--I: mechanical valves.

    Science.gov (United States)

    Cheema, Faisal H; Hussain, Nasir; Kossar, Alexander P; Polvani, Gianluca

    2013-04-01

    Valvular heart disease, inherited or acquired, affects more than 5 million Americans yearly. Whereas medical treatment is beneficial in the initial stages of valvular heart disease, surgical correction provides symptomatic relief and long-term survival benefits. Surgical options include either repair or replacement using mechanical or bio-prosthetic valves. Patient age and the post-operative need for anticoagulation therapy are major determinants of the choice between use of mechanical or bio-prosthetic valves. Since the first mechanical valves were made available several decades ago, the incorporation of increasingly sophisticated materials and methodologies has led to substantial improvements in the valve design, and has catalyzed a parallel increase in the amount of patents issued for these emerging technologies. In this paper, we have chronologically reviewed such patents, briefly discussed various challenges that mechanical heart valve implementation is faced with and finally reviewed some of the strategies employed to overcome such obstacles. An ideal prosthetic heart valve would comprehensively mimic the natural hemodynamics and physiology of the native heart valve. Additionally, such a valve would be easily implantable, associated with a minimal risk of thrombosis and thus need for anti-coagulation, and with a proven long-term durability. With cutting edge technological advancements in the recent times, the ongoing innovative and collaborative efforts of physicians, scientists, and engineers will not seize until an ideal mechanical heart valve becomes a reality.

  4. The self-expanding Symetis Acurate does not increase cerebral microembolic load when compared to the balloon-expandable Edwards Sapien prosthesis: a transcranial Doppler study in patients undergoing transapical aortic valve implantation.

    Directory of Open Access Journals (Sweden)

    Gabor Erdoes

    Full Text Available OBJECTIVES: The aim of this study was to quantify potential differences in count, frequency and pattern of high-intensity transient signals (HITS during transapical transcatheter aortic valve implantation (TA-TAVI, by comparing the Symetis Acurate TA (SA with the balloon-expandable Edwards Sapien XT (ES system. BACKGROUND: Recently, the Symetis Acurate TA revalving system has been introduced for TA-TAVI. The Symetis Acurate TA aortic bioprosthesis is self-expanding and is deployed by a specific two-step implantation technique. Whether this novel method increases the load of intraprocedural emboli, detected by transcranial Doppler ultrasound (TCD as HITS, or not is not clear. METHODS: Twenty-two patients (n = 11 in each study arm, median logistic EuroScore 20%, median STS score 7% displayed continuous TCD signals of good quality throughout the entire TA-TAVI procedure and were included in the final analysis. Data are presented as median with interquartile ranges. RESULTS: No significant differences were detected in total procedural or interval-related HITS load (SA: 303 [200; 594], ES: 499 [285; 941]; p = 0.16. With both devices, HITS peaked during prosthesis deployment (PD, whereas significantly fewer HITS occurred during instrumentation (SA: p = 0.002; ES: < 0.001 or post-implantation PI (SA: p = 0.007; ES: < 0.001. PD-associated HITS amounted to almost half of the total HITS load. One patient suffered new disabling stroke at 30 days. Thirty-day mortality amounted to 13.6% (3 of 22 patients. CONCLUSIONS: Simplified transapical delivery using the self-expanding SA device does not increase HITS, despite of a two-step deployment technique with more interactions with the native aortic valve, when compared to the balloon-expandable ES valve. The similarity in HITS count, frequency and pattern with the two systems suggests a common mechanism for the release of cerebral microemboli.

  5. The self-expanding Symetis Acurate does not increase cerebral microembolic load when compared to the balloon-expandable Edwards Sapien prosthesis: a transcranial Doppler study in patients undergoing transapical aortic valve implantation.

    Science.gov (United States)

    Erdoes, Gabor; Huber, Christoph; Basciani, Reto; Stortecky, Stefan; Windecker, Stephan; Wenaweser, Peter; Carrel, Thierry; Eberle, Balthasar

    2014-01-01

    The aim of this study was to quantify potential differences in count, frequency and pattern of high-intensity transient signals (HITS) during transapical transcatheter aortic valve implantation (TA-TAVI), by comparing the Symetis Acurate TA (SA) with the balloon-expandable Edwards Sapien XT (ES) system. Recently, the Symetis Acurate TA revalving system has been introduced for TA-TAVI. The Symetis Acurate TA aortic bioprosthesis is self-expanding and is deployed by a specific two-step implantation technique. Whether this novel method increases the load of intraprocedural emboli, detected by transcranial Doppler ultrasound (TCD) as HITS, or not is not clear. Twenty-two patients (n = 11 in each study arm, median logistic EuroScore 20%, median STS score 7%) displayed continuous TCD signals of good quality throughout the entire TA-TAVI procedure and were included in the final analysis. Data are presented as median with interquartile ranges. No significant differences were detected in total procedural or interval-related HITS load (SA: 303 [200; 594], ES: 499 [285; 941]; p = 0.16). With both devices, HITS peaked during prosthesis deployment (PD), whereas significantly fewer HITS occurred during instrumentation (SA: p = 0.002; ES: < 0.001) or post-implantation PI (SA: p = 0.007; ES: < 0.001). PD-associated HITS amounted to almost half of the total HITS load. One patient suffered new disabling stroke at 30 days. Thirty-day mortality amounted to 13.6% (3 of 22 patients). Simplified transapical delivery using the self-expanding SA device does not increase HITS, despite of a two-step deployment technique with more interactions with the native aortic valve, when compared to the balloon-expandable ES valve. The similarity in HITS count, frequency and pattern with the two systems suggests a common mechanism for the release of cerebral microemboli.

  6. Heart valve surgery

    Science.gov (United States)

    Valve replacement; Valve repair; Heart valve prosthesis; Mechanical valves; Prosthetic valves ... can relieve your symptoms and prolong your life. Mechanical heart valves do not often fail. However, blood clots can ...

  7. Evoked EMG-based torque prediction under muscle fatigue in implanted neural stimulation

    Science.gov (United States)

    Hayashibe, Mitsuhiro; Zhang, Qin; Guiraud, David; Fattal, Charles

    2011-10-01

    In patients with complete spinal cord injury, fatigue occurs rapidly and there is no proprioceptive feedback regarding the current muscle condition. Therefore, it is essential to monitor the muscle state and assess the expected muscle response to improve the current FES system toward adaptive force/torque control in the presence of muscle fatigue. Our team implanted neural and epimysial electrodes in a complete paraplegic patient in 1999. We carried out a case study, in the specific case of implanted stimulation, in order to verify the corresponding torque prediction based on stimulus evoked EMG (eEMG) when muscle fatigue is occurring during electrical stimulation. Indeed, in implanted stimulation, the relationship between stimulation parameters and output torques is more stable than external stimulation in which the electrode location strongly affects the quality of the recruitment. Thus, the assumption that changes in the stimulation-torque relationship would be mainly due to muscle fatigue can be made reasonably. The eEMG was proved to be correlated to the generated torque during the continuous stimulation while the frequency of eEMG also decreased during fatigue. The median frequency showed a similar variation trend to the mean absolute value of eEMG. Torque prediction during fatigue-inducing tests was performed based on eEMG in model cross-validation where the model was identified using recruitment test data. The torque prediction, apart from the potentiation period, showed acceptable tracking performances that would enable us to perform adaptive closed-loop control through implanted neural stimulation in the future.

  8. The porcine valve type predicts obstructive thrombosis beyond the first three postoperative months in bioprostheses in the aortic position.

    Science.gov (United States)

    Jander, Nikolaus; Sommer, Harriet; Pingpoh, Clarence; Kienzle, Rolf-Peter; Martin, Gabriele; Zeh, Wolfgang; Pache, Gregor; Siepe, Matthias; Beyersdorf, Friedhelm; Schumacher, Martin; Neumann, Franz-Josef; Minners, Jan

    2015-11-15

    Obstructive thrombosis of bioprosthetic valves is considered rare but may have dramatic consequences for the individual patient including repeat valve replacement, thrombolysis, or long-term anticoagulation. Whether the risk of obstructive thrombosis is dependent on the type of bioprosthesis (porcine versus bovine pericardial) is uncertain. Between 2007 and 2012 a total of 1751 patients received a single stented bioprosthesis in the aortic valve position, 749 (43%) were porcine and 1002 (57%) bovine. During a mean follow-up of 3.4±1.9years, obstructive thrombosis (identified by an increase in mean pressure gradient≥20mm Hg or a decrease in velocity ratio≥0.05 and confirmed by either ECG-gated computer tomography, a return to baseline of stenosis parameters under treatment with a vitamin K antagonist, or histology in case of reoperation) was diagnosed in 17 patients with a porcine (2.3%) and none with a bovine valve (pporcine valve (pporcine valves. These findings were further confirmed in a Poisson model and a competing risk model including all-cause mortality. Treatment of obstructive thrombosis with a vitamin K antagonist was safe and effective in 15/17 patients. The porcine valve type is an independent predictor of obstructive thrombosis in bioprostheses in the aortic position. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  9. Study on decellularized porcine aortic valve/poly (3-hydroxybutyrate-co-3-hydroxyhexanoate) hybrid heart valve in sheep model.

    Science.gov (United States)

    Wu, Song; Liu, Ying-Long; Cui, Bin; Qu, Xiang-Hua; Chen, Guo-Qiang

    2007-09-01

    To overcome shortcomings of current heart valve prostheses, novel hybrid valves were fabricated from decellularized porcine aortic valves coated with poly (3-hydroxybutyrate-co-3-hydroxyhexanoate [PHBHHx]). In the mechanical test in vitro, the biomechanical performance of hybrid valve was investigated. In an in vivo study, hybrid valve conduits were implanted in pulmonary position in sheep without cardiopulmonary bypass. Uncoated grafts were used as control. The valves were explanted and examined histologically and biochemically 16 weeks after surgery. The hybrid valve conduits maintained original shapes, were covered by a confluent layer of cells, and had less calcification than uncoated control. The mechanical test in vitro revealed that PHBHHx coating improved tensile strength. The results in vivo indicated that PHBHHx coating reduced calcification and promoted the repopulation of hybrid valve with the recipient's cells resembling native valve tissue. The hybrid valve may provide superior valve replacement with current techniques.

  10. New continuous air pumping technique to improve clinical outcomes of descemet-stripping automated endothelial keratoplasty in asian patients with previous ahmed glaucoma valve implantation.

    Directory of Open Access Journals (Sweden)

    Chang-Min Liang

    Full Text Available BACKGROUND: To evaluate the outcomes of Descemet-stripping automated endothelial keratoplasty (DSAEK with the use of continuous air pumping technique in Asian eyes with previous Ahmed glaucoma valve implantation. METHODS: The DSAEK procedure was modified in that complete air retention of the anterior chamber was maintained for 10 min using continuous air pumping at 30 mm Hg. The primary outcome measurement was graft survival, and postoperative clinical features including, rate of graft detachment, endothelial cell count, intraocular pressure (IOP, surgical time and cup/disc ratio were also recorded. RESULTS: A total of 13 eyes of 13 patients which underwent modified DSAEK and 6 eyes of 6 patients which underwent conventional DSAEK were included. There was a significant difference in graft survival curves between two groups (P = 0.029; the 1-year graft survival rates were estimated as 100% and 66.7% for patients with modified DSAEK and those with traditional DSAEK, respectively. The rate of graft detachment were 0% and 33.3% for the modified DSAEK and conventional DSAEK groups, respectively (P = 0.088. The significantly lowered surgical time for air tamponade was noted in the modified DSAEK group compared to that in the conventional DSAEK group [median (IQR: 10.0 (10.0, 10.0 min vs. 24.5 (22.0, 27.0 min; P<0.001] Postoperatively, patients in the modified DSAEK group had significantly lower IOP as compared to the conventional DSAEK group [12.0 (11.0, 15.0 mm Hg vs. 16.0 (15.0, 18.0 mm Hg; P = 0.047]. Modified DSAEK patients had higher endothelial cell counts as compared to conventional DSAEK patients [2148.0 (1964.0, 2218.0 vs. 1529.0 (713.0, 2014.0], but the difference did not reach statistical significance (P = 0.072. CONCLUSIONS: New continuous air pumping technique in DSAEK can be performed safely and effectively in patients with prior GDDs placement who have corneal failure.

  11. Standard 12-lead electrocardiography measures predictive of increased appropriate therapy in implantable cardioverter defibrillator recipients.

    Science.gov (United States)

    Shi, Bijia; Harding, Scott A; Jimenez, Alejandro; Larsen, Peter D

    2013-06-01

    Identification of patients most likely to benefit from implantable cardioverter defibrillator (ICD) implant remains a complex challenge. This study aimed to investigate the utility of measures derived from standard 10 s 12-lead electrocardiogrphy (ECG) without complex signal processing in predicting appropriate therapy in an ICD population. We examined 108 ICD patients for primary (n = 32) and secondary prevention (n = 76). Baseline clinical data and characteristics of QRS complex, T-wave, and heart rate from standard 12-lead ECG were examined and related to the occurrence of subsequent appropriate therapy. Over a mean follow-up of 29 ± 11 months, 44% of patients received appropriate therapy. Patients with depressed heart rate variability (HRV) (≤6.5%) were 2.68 [95% confidence interval (CI) 1.21-5.90, P = 0.015] times more likely to receive appropriate therapy than patients with HRV >6.5%. In patients with bundle branch block (BBB), large QRS dispersion of >39 ms was associated with 2.88 times risk (95% CI 1.24-6.71, P = 0.014) of experiencing appropriate therapy than those with QRS dispersion 0.4 mV. History of atrial arrhythmia [hazard ratio (HR) = 2.30, 95% CI 1.29-4.12, P = 0.005] and secondary prevention (HR = 2.55, 95% CI 1.14-5.71, P = 0.022) were also predictive of device therapy. Measurements from standard 12-lead ECG were predictive of appropriate therapy in a heterogeneous ICD population. Incorporation of 12-lead ECG parameters such as these into risk stratification models may improve our ability to select patients for ICD implantation.

  12. Prediction of Speech Recognition in Cochlear Implant Users by Adapting Auditory Models to Psychophysical Data

    Directory of Open Access Journals (Sweden)

    Svante Stadler

    2009-01-01

    Full Text Available Users of cochlear implants (CIs vary widely in their ability to recognize speech in noisy conditions. There are many factors that may influence their performance. We have investigated to what degree it can be explained by the users' ability to discriminate spectral shapes. A speech recognition task has been simulated using both a simple and a complex models of CI hearing. The models were individualized by adapting their parameters to fit the results of a spectral discrimination test. The predicted speech recognition performance was compared to experimental results, and they were significantly correlated. The presented framework may be used to simulate the effects of changing the CI encoding strategy.

  13. Estudo experimental do implante transcateter de prótese valvada autoexpansível na via de saída do ventrículo direito em porcos Transcatheter implantation of self-expandable valved prosthesis in outlet right ventricle an experimental study in pigs

    Directory of Open Access Journals (Sweden)

    José Cícero Stocco Guilhen

    2011-09-01

    Full Text Available INTRODUÇÃO: Nos pacientes portadores de cardiopatias congênitas que foram submetidos à valvotomia pulmonar ou cirurgias de ampliação com o uso do anel da válvula pulmonar, a insuficiência ou estenose pulmonar residual pode acarretar falência cardíaca direita com deterioração clínica. Essas crianças necessitam de múltiplas intervenções ao longo de suas vidas, que impõem uma elevada taxa de morbidade e mortalidade. OBJETIVO: Desenvolvimento de uma técnica menos invasiva para implante de uma prótese valvada através do ventrículo direito. MÉTODOS: A prótese valvada consiste em um anel metálico construído com nitinol autoexpansível, revestida de poliéster, onde três cúspides de pericárdio bovino foram montadas. Doze porcos foram utilizados para a realização dos implantes. Foi realizado controle ecocardiográfico imediatamente após o implante e com uma, quatro, oito e 12 semanas. RESULTADOS: Um animal apresentou refluxo de grau moderado a importante e outros três refluxo de grau leve. Os gradientes transvalvares medidos antes do implante variavam entre 3 a 6 mmHg, sendo que, logo após o implante, houve aumento dos gradientes que variaram de 7 a 45 mmHg. Houve queda desses gradientes, sendo que em apenas quatro dos 12 animais os gradientes estavam acima de 20 mmHg. Em seis animais, ocorreu a formação de trombo na prótese, sendo esta a complicação mais frequente. CONCLUSÃO: Esses achados evidenciam a necessidade da realização de estudos com a utilização de anticoagulantes e ou antiagregantes plaquetários na tentativa de diminuir esse evento. O estudo pretende apresentar subsídios para o início do emprego de próteses valvares que poderiam ser implantadas através de técnicas menos invasivasINTRODUCTION: Patients with congenital heart disease who underwent pulmonary valvotomy or surgery to open the pulmonary valve ring are prone to develop residual pulmonary insufficiency or stenosis that may lead to

  14. Development and verification of methods for predicting flow rates through leaks in valves and couplings

    Science.gov (United States)

    Russell, John M.

    1993-01-01

    This is the final report of a research effort which addresses the title problem. The report discusses two broad models of flows, which represent the following extreme cases: (1) inertia-dominated flow, where friction is relatively insignificant; and (2) friction-dominated flow where inertia is insignificant. In class (2), the leak channel might consist of the gap between a scratch in a plastic seal and a polished metal plate against which the seal is pressed. Here, the cross section of the leak channel is modeled as a flat bottomed crescent. A publication generated under the present grant period presents an exact solution of the equations of fully-developed laminar pipe flow of a liquid in the case of a crescent beneath a hyperbolic arc. A Master's thesis project supported by the present grant presents the corresponding solution beneath a circular arc. A second publication reviews the flow of a gas through the same channel, which may be analyzed by a standard one-dimensional model (Fanno flow) for an engineering approximation. Finally, the report discusses the design and progress in the fabrication of a leak-test cell, in which one may measure the flow of fluid through a controlled flaw in a seal. The aim of such measurements is to furnish data for comparison with the predictions of the theory.

  15. Development of an effective valve packing program

    Energy Technology Data Exchange (ETDEWEB)

    Hart, K.A.

    1996-12-01

    Current data now shows that graphite valve packing installed within the guidance of a controlled program produces not only reliable stem sealing but predictable running loads. By utilizing recent technological developments in valve performance monitoring for both MOV`s and AOV`s, valve packing performance can be enhanced while reducing maintenance costs. Once known, values are established for acceptable valve packing loads, the measurement of actual valve running loads via the current MOV/AOV diagnostic techniques can provide indication of future valve stem sealing problems, improper valve packing installation or identify the opportunity for valve packing program improvements. At times the full benefit of these advances in material and predictive technology remain under utilized due to simple past misconceptions associated with valve packing. This paper will explore the basis for these misconceptions, provide general insight into the current understanding of valve packing and demonstrate how with this new understanding and current valve diagnostic equipment the key aspects required to develop an effective, quality valve packing program fit together. The cost and operational benefits provided by this approach can be significant impact by the: elimination of periodic valve repacking, reduction of maintenance costs, benefits of leak-free valve operation, justification for reduced Post Maintenance Test Requirements, reduced radiation exposure, improved plant appearance.

  16. Transcatheter pulmonary valve replacement by hybrid approach using a novel polymeric prosthetic heart valve: proof of concept in sheep.

    Science.gov (United States)

    Zhang, Ben; Chen, Xiang; Xu, Tong-yi; Zhang, Zhi-gang; Li, Xin; Han, Lin; Xu, Zhi-yun

    2014-01-01

    Since 2000, transcatheter pulmonary valve replacement has steadily advanced. However, the available prosthetic valves are restricted to bioprosthesis which have defects like poor durability. Polymeric heart valve is thought as a promising alternative to bioprosthesis. In this study, we introduced a novel polymeric transcatheter pulmonary valve and evaluated its feasibility and safety in sheep by a hybrid approach. We designed a novel polymeric trileaflet transcatheter pulmonary valve with a balloon-expandable stent, and the valve leaflets were made of 0.1-mm expanded polytetrafluoroethylene (ePTFE) coated with phosphorylcholine. We chose glutaraldehyde-treated bovine pericardium valves as control. Pulmonary valve stents were implanted in situ by a hybrid transapical approach in 10 healthy sheep (8 for polymeric valve and 2 for bovine pericardium valve), weighing an average of 22.5±2.0 kg. Angiography and cardiac catheter examination were performed after implantation to assess immediate valvular functionality. After 4-week follow-up, angiography, echocardiography, computed tomography, and cardiac catheter examination were used to assess early valvular function. One randomly selected sheep with polymeric valve was euthanized and the explanted valved stent was analyzed macroscopically and microscopically. Implantation was successful in 9 sheep. Angiography at implantation showed all 9 prosthetic valves demonstrated orthotopic position and normal functionality. All 9 sheep survived at 4-week follow-up. Four-week follow-up revealed no evidence of valve stent dislocation or deformation and normal valvular and cardiac functionality. The cardiac catheter examination showed the peak-peak transvalvular pressure gradient of the polymeric valves was 11.9±5.0 mmHg, while that of two bovine pericardium valves were 11 and 17 mmHg. Gross morphology demonstrated good opening and closure characteristics. No thrombus or calcification was seen macroscopically. This design of the

  17. Speech processor data logging helps in predicting early linguistic outcomes in implanted children.

    Science.gov (United States)

    Guerzoni, Letizia; Cuda, Domenico

    2017-10-01

    To analyse the value of listening-data logged in the speech processor on the prediction of the early auditory and linguistic skills in children who received a cochlear implant in their first 2 years of life. Prospective observational non-randomized study. Ten children with profound congenital sensorineural hearing loss were included in the study. The mean age at CI activation was 16.9 months (SD ± 7.2; range 10-24). The auditory skills were evaluated with the Infant Toddler Meaningful Inventory Scale and the Category of Auditory Performance. Lexical level was assessed with the MacArthur-Bates Communicative Development Inventory. The overall data of average daily use and acoustic scene-analyses were extracted from Data Logging system. The effect of the one-year cumulative listening time to speech (in quiet) and speech-in-noise on the auditory and lexical scores was analysed. A significant positive correlation was found between speech in quiet exposure time at low loudness level (80 dB). The Category of Auditory Performance was not related to the logged data. The listening environment can influence the early functional outcomes in younger implanted children. In this perspective, the data logging system is a promising tool in predicting early linguistic and auditory outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Beyond Framingham risk factors and coronary calcification: does aortic valve calcification improve risk prediction? The Heinz Nixdorf Recall Study.

    Science.gov (United States)

    Kälsch, Hagen; Lehmann, Nils; Mahabadi, Amir A; Bauer, Marcus; Kara, Kaffer; Hüppe, Patricia; Moebus, Susanne; Möhlenkamp, Stefan; Dragano, Nico; Schmermund, Axel; Stang, Andreas; Jöckel, Karl-Heinz; Erbel, Raimund

    2014-06-01

    Aortic valve calcification (AVC) is considered a manifestation of atherosclerosis. In this study, we investigated whether AVC adds to cardiovascular risk prediction beyond Framingham risk factors and coronary artery calcification (CAC). A total of 3944 subjects from the population based Heinz Nixdorf Recall Study (59.3±7.7 years; 53% females) were evaluated for coronary events, stroke, and cardiovascular disease (CVD) events (including all plus CV death) over 9.1±1.9 years. CT scans were performed to quantify AVC. Cox proportional hazards regressions and Harrell's C were used to examine AVC as event predictor in addition to risk factors and CAC. During follow-up, 138 (3.5%) subjects experienced coronary events, 101 (2.6%) had a stroke, and 257 (6.5%) experienced CVD events. In subjects with AVC>0 versus AVC=0 the incidence of coronary events was 8.0% versus 3.0% (p<0.001) and the incidence of CVD events was 13.0% versus 5.7% (p<0.001). The frequency of events increased significantly with increasing AVC scores (p<0.001). After adjustment for Framingham risk factors, high AVC scores (3rd tertile) remained independently associated with coronary events (HR 2.21, 95% CI 1.28 to 3.81) and CVD events (HR 1.67, 95% CI 1.08 to 2.58). After further adjustment for CAC score, HRs were attenuated (coronary events 1.55, 95% CI 0.89 to 2.69; CVD events 1.29, 95% CI 0.83 to 2.00). When adding AVC to the model containing traditional risk factors and CAC, Harrell's C indices did not increase for coronary events (from 0.744 to 0.744) or CVD events (from 0.759 to 0.759). AVC is associated with incident coronary and CVD events independent of Framingham risk factors. However, AVC fails to improve cardiovascular event prediction over Framingham risk factors and CAC. 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.

  19. Optimizing Safety, Predictability, and Aesthetics in Direct to Implant Immediate Breast Reconstruction: Evolution of Surgical Technique.

    Science.gov (United States)

    Kalus, Ram; Dixon Swartz, Jennifer; Metzger, Sarah Cristina

    2016-06-01

    Although immediate breast reconstruction with the insertion of a permanent prosthesis rather than a tissue expander (direct to implant [DTI]) has become gradually more preferred and requested by patients, the technique has yet to be fully embraced by most plastic surgeons, presumably due to concerns of patient safety and perceived higher complication and revision rates, despite not being supported by the literature. The authors review the senior author's protocol for patient selection and surgical technique in DTI reconstructions. A simple device is introduced which adds predictability and control in determining the inset suture line for the acellular dermal matrix and thus the position of the inframammary fold and lateral mammary fold, resulting in improved aesthetic outcomes, reduced complications, and reduced reoperation rates. A retrospective review of our one surgeon experience with 134 DTI breast reconstructions in 77 patients between 2006 and 2015 is presented. The series is further subdivided into 74 reconstructions in 43 patients in whom their reconstruction was performed before the use of a patented 2-dimensional (2-D) template, and 60 reconstructions in 34 patients in whom the template was used. The overall complication rate requiring reoperation in the first 54 reconstructions was 50% versus 15% in the last 84. Failure of the reconstruction, defined by explantation, occurred in 11 of 74 reconstructions (14.9%) before the use of 2-D templates, and in 5 of 60 reconstructions (8.3%) in which templates were used, representing a 44% reduction. The revision rate specifically for implant malposition dropped from 18.6% before the use of templates to 2.9% after the incorporation of templates. Fifty-three reconstructions in 33 patients (40%) had no complications and no reoperations, correctly described as "one and done." Direct to implant reconstruction can be technically more demanding and exacting than 2-stage expander/implant reconstructions. A review of this

  20. Left Main Coronary Artery Compression following Melody Pulmonary Valve Implantation: Use of Impella Support as Rescue Therapy and Perioperative Challenges with ECMO

    Directory of Open Access Journals (Sweden)

    Erica D. Wittwer

    2014-01-01

    Full Text Available The purpose of this case is to describe the complex perioperative management of a 30-year-old woman with congenital heart disease and multiple resternotomies presenting with pulmonary homograft dysfunction and evaluation for percutaneous pulmonary valve replacement. Transvenous, transcatheter Melody valve placement caused left main coronary artery occlusion and cardiogenic shock. An Impella ventricular assist device (VAD provided rescue therapy during operating room transport for valve removal and pulmonary homograft replacement. ECMO support was required following surgery. Several days later during an attempted ECMO wean, her hemodynamics deteriorated abruptly. Transesophageal and epicardial echocardiography identified pulmonary graft obstruction, requiring homograft revision due to large thrombosis. This case illustrates a role for Impella VAD as bridge to definitive procedure after left coronary occlusion and describes management of complex perioperative ECMO support challenges.

  1. Distinguishing predictive profiles for patient-based risk assessment and diagnostics of plaque induced, surgically and prosthetically triggered peri-implantitis.

    Science.gov (United States)

    Canullo, Luigi; Tallarico, Marco; Radovanovic, Sandro; Delibasic, Boris; Covani, Ugo; Rakic, Mia

    2016-10-01

    To investigate whether specific predictive profiles for patient-based risk assessment/diagnostics can be applied in different subtypes of peri-implantitis. This study included patients with at least two implants (one or more presenting signs of peri-implantitis). Anamnestic, clinical, and implant-related parameters were collected and scored into a single database. Dental implant was chosen as the unit of analysis, and a complete screening protocol was established. The implants affected by peri-implantitis were then clustered into three subtypes in relation to the identified triggering factor: purely plaque-induced or prosthetically or surgically triggered peri-implantitis. Statistical analyses were performed to compare the characteristics and risk factors between peri-implantitis and healthy implants, as well as to compare clinical parameters and distribution of risk factors between plaque, prosthetically and surgically triggered peri-implantitis. The predictive profiles for subtypes of peri-implantitis were estimated using data mining tools including regression methods and C4.5 decision trees. A total of 926 patients previously treated with 2812 dental implants were screened for eligibility. Fifty-six patients (6.04%) with 332 implants (4.44%) met the study criteria. Data from 125 peri-implantitis and 207 healthy implants were therefore analyzed and included in the statistical analysis. Within peri-implantitis group, 51 were classified as surgically triggered (40.8%), 38 as prosthetically triggered (30.4%), and 36 as plaque-induced (28.8%) peri-implantitis. For peri-implantitis, 51 were associated with surgical risk factor (40.8%), 38 with prosthetic risk factor (30.4%), 36 with purely plaque-induced risk factor (28.8%). The variables identified as predictors of peri-implantitis were female sex (OR = 1.60), malpositioning (OR = 48.2), overloading (OR = 18.70), and bone reconstruction (OR = 2.35). The predictive model showed 82.35% of accuracy and

  2. Impact of renal dysfunction on mid-term outcome after transcatheter aortic valve implantation: a systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Chi Chen

    Full Text Available There is conflicting evidence regarding the impact of preexisting renal dysfunction (RD on mid-term outcomes after transcatheter aortic valve implantation (TAVI in patients with symptomatic aortic stenosis (AS.Forty-seven articles representing 32,131 patients with AS undergoing a TAVI procedure were included in this systematic review and meta-analysis. Pooled analyses were performed with both univariate and multivariate models, using a fixed or random effects method when appropriate. Compared with patients with normal renal function, mid-term mortality was significantly higher in patients with preexisting RD, as defined by the author (univariate hazard ratio [HR]: 1.69; 95% confidence interval [CI]: 1.50-1.90; multivariate HR: 1.47; 95% CI: 1.17-1.84, baseline estimated glomerular filtration rate (eGFR (univariate HR: 1.65; 95% CI: 1.47-1.86; multivariate HR: 1.46; 95% CI: 1.24-1.71, and serum creatinine (univariate HR: 1.69; 95% CI: 1.48-1.92; multivariate HR: 1.65; 95% CI: 1.36-1.99. Advanced stage of chronic kidney disease (CKD stage 3-5 was strongly related to bleeding (univariate HR in CKD stage 3: 1.30, 95% CI: 1.13-1.49; in CKD stage 4: 1.30, 95% CI: 1.04-1.62, acute kidney injure (AKI (univariate HR in CKD stage 3: 1.28, 95% CI: 1.03-1.59; in CKD stage 4: 2.27, 95% CI: 1.74-2.96, stroke (univariate HR in CKD stage 4: 3.37, 95% CI: 1.52-7.46, and mid-term mortality (univariate HR in CKD stage 3: 1.57, 95% CI: 1.26-1.95; in CKD stage 4: 2.77, 95% CI: 2.06-3.72; in CKD stage 5: 2.64, 95% CI: 1.91-3.65 compared with CKD stage 1+2. Patients with CKD stage 4 had a higher incidence of AKI (univariate HR: 1.70, 95% CI: 1.34-2.16 and all-cause death (univariate HR: 1.60, 95% CI: 1.28-1.99 compared with those with CKD stage 3. A per unit decrease in serum creatinine was also associated with a higher mortality at mid-term follow-up (univariate HR: 1.24, 95% CI: 1.18-1.30; multivariate HR: 1.19, 95% CI: 1.08-1.30.Preexisting RD was associated with

  3. In vivo behavior of epoxy-crosslinked porcine heart valve cusps and walls

    NARCIS (Netherlands)

    van Wachem, Pauline B.; Brouwer, Linda A.; Zeeman, R.; Dijkstra, Pieter J.; Feijen, Jan; Hendriks, Marc; Cahalan, Patrick T.; van Luyn, Marja J.A.

    2000-01-01

    Calcification limits the long-term durability of xenograft glutaraldehyde-crosslinked heart valves. In this study, epoxy-crosslinked porcine aortic valve tissue was evaluated after subcutaneous implantation in weanling rats. Non-crosslinked valves and valves crosslinked with glutaraldehyde or

  4. Pulmonary heart valve replacement using stabilized acellular xenogeneic scaffolds; effects of seeding with autologous stem cells

    Directory of Open Access Journals (Sweden)

    Harpa Marius Mihai

    2015-12-01

    Full Text Available Background: We hypothesized that an ideal heart valve replacement would be acellular valve root scaffolds seeded with autologous stem cells. To test this hypothesis, we prepared porcine acellular pulmonary valves, seeded them with autologous adipose derived stem cells (ADSCs and implanted them in sheep and compared them to acellular valves.

  5. In vivo behavior of epoxy-crosslinked porcine heart valve cusps and walls

    NARCIS (Netherlands)

    van Wachem, PB; Brouwer, LA; Zeeman, R; Dijkstra, PJ; Feijen, J; Hendriks, M; Cahalan, PT; van Luyn, MJA

    Calcification limits the long-term durability of xenograft glutaraldehyde-crosslinked heart valves. In this study, epoxy-crosslinked porcine aortic valve tissue was evaluated after subcutaneous implantation in weanling rats, Non-crosslinked valves and valves crosslinked with glutaraldehyde or

  6. Success and High Predictability of Intraorally Welded Titanium Bar in the Immediate Loading Implants

    OpenAIRE

    Vaniel Fogli; Michele Camerini; Dorina Lauritano; Francesco Carinci

    2014-01-01

    The implants failure may be caused by micromotion and stress exerted on implants during the phase of bone healing. This concept is especially true in case of implants placed in atrophic ridges. So the primary stabilization and fixation of implants are an important goal that can also allow immediate loading and oral rehabilitation on the same day of surgery. This goal may be achieved thanks to the technique of welding titanium bars on implant abutments. In fact, the procedure can be performed ...

  7. Timing of implant placement: planning and procedures for predictable clinical and aesthetic outcomes.

    Science.gov (United States)

    Danesh-Meyer, Michael

    2012-04-01

    The placement of dental implants is dependent on a number of factors relating to both the patient and the site in which implant placement is contemplated. Additionally, there has been a general trend towards immediacy in implant therapy. This paper considers case selection and clinical decision-making and treatment guidelines in cases where immediate implant placement is contemplated. Treatment alternatives, including site preservation, early and delayed implant placement are also discussed.

  8. Matched Comparison of Self-Expanding Transcatheter Heart Valves for the Treatment of Failed Aortic Surgical Bioprosthesis: Insights From the Valve-in-Valve International Data Registry (VIVID).

    Science.gov (United States)

    Alnasser, Sami; Cheema, Asim N; Simonato, Matheus; Barbanti, Marco; Edwards, Jeremy; Kornowski, Ran; Horlick, Eric; Wijeysundera, Harindra C; Testa, Luca; Bedogni, Francesco; Amrane, Hafid; Walther, Thomas; Pelletier, Marc; Latib, Azeem; Laborde, Jean-Claude; Hildick-Smith, David; Kim, Won-Keun; Tchetche, Didier; Agrifoglio, Marco; Sinning, Jan-Malte; van Boven, Ad J; Kefer, Joëlle; Frerker, Christian; van Mieghem, Nicolas M; Linke, Axel; Worthley, Stephen; Asgar, Anita; Sgroi, Carmelo; Aziz, Mina; Danenberg, Haim D; Labinaz, Marino; Manoharan, Ganesh; Cheung, Anson; Webb, John G; Dvir, Danny

    2017-04-01

    Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm2; P=0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P=0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P=0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P=0.03). In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation. © 2017 American Heart Association, Inc.

  9. Preschool speech intelligibility and vocabulary skills predict long-term speech and language outcomes following cochlear implantation in early childhood.

    Science.gov (United States)

    Castellanos, Irina; Kronenberger, William G; Beer, Jessica; Henning, Shirley C; Colson, Bethany G; Pisoni, David B

    2014-07-01

    Speech and language measures during grade school predict adolescent speech-language outcomes in children who receive cochlear implants (CIs), but no research has examined whether speech and language functioning at even younger ages is predictive of long-term outcomes in this population. The purpose of this study was to examine whether early preschool measures of speech and language performance predict speech-language functioning in long-term users of CIs. Early measures of speech intelligibility and receptive vocabulary (obtained during preschool ages of 3-6 years) in a sample of 35 prelingually deaf, early-implanted children predicted speech perception, language, and verbal working memory skills up to 18 years later. Age of onset of deafness and age at implantation added additional variance to preschool speech intelligibility in predicting some long-term outcome scores, but the relationship between preschool speech-language skills and later speech-language outcomes was not significantly attenuated by the addition of these hearing history variables. These findings suggest that speech and language development during the preschool years is predictive of long-term speech and language functioning in early-implanted, prelingually deaf children. As a result, measures of speech-language functioning at preschool ages can be used to identify and adjust interventions for very young CI users who may be at long-term risk for suboptimal speech and language outcomes.

  10. 3D printing based on cardiac CT assists anatomic visualization prior to transcatheter aortic valve replacement.

    Science.gov (United States)

    Ripley, Beth; Kelil, Tatiana; Cheezum, Michael K; Goncalves, Alexandra; Di Carli, Marcelo F; Rybicki, Frank J; Steigner, Mike; Mitsouras, Dimitrios; Blankstein, Ron

    2016-01-01

    3D printing is a promising technique that may have applications in medicine, and there is expanding interest in the use of patient-specific 3D models to guide surgical interventions. To determine the feasibility of using cardiac CT to print individual models of the aortic root complex for transcatheter aortic valve replacement (TAVR) planning as well as to determine the ability to predict paravalvular aortic regurgitation (PAR). This retrospective study included 16 patients (9 with PAR identified on blinded interpretation of post-procedure trans-thoracic echocardiography and 7 age, sex, and valve size-matched controls with no PAR). 3D printed models of the aortic root were created from pre-TAVR cardiac computed tomography data. These models were fitted with printed valves and predictions regarding post-implant PAR were made using a light transmission test. Aortic root 3D models were highly accurate, with excellent agreement between annulus measurements made on 3D models and those made on corresponding 2D data (mean difference of -0.34 mm, 95% limits of agreement: ± 1.3 mm). The 3D printed valve models were within 0.1 mm of their designed dimensions. Examination of the fit of valves within patient-specific aortic root models correctly predicted PAR in 6 of 9 patients (6 true positive, 3 false negative) and absence of PAR in 5 of 7 patients (5 true negative, 2 false positive). Pre-TAVR 3D-printing based on cardiac CT provides a unique patient-specific method to assess the physical interplay of the aortic root and implanted valves. With additional optimization, 3D models may complement traditional techniques used for predicting which patients are more likely to develop PAR. Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  11. Can pre-implantation biopsies predict renal allograft function in pediatric renal transplant recipients?

    Directory of Open Access Journals (Sweden)

    Jameela A. Kari

    2015-11-01

    Full Text Available Objectives: To determine the utility of pre-implantation renal biopsy (PIB to predict renal allograft outcomes. Methods: This is a retrospective review of all patients that underwent PIB from January 2003 to December 2011 at the Great Ormond Street Hospital for Children in London, United Kingdom. Thirty-two male patients (56% aged 1.5-16 years (median: 10.2 at the time of transplantation were included in the study and followed-up for 33 (6-78 months. The results were compared with 33 controls. Results: The PIB showed normal histopathological findings in 13 patients (41%, mild chronic vascular changes in 8 (25%, focal tubular atrophy in one, moderate to severe chronic vascular change in 3, mild to moderate acute tubular damage in 6, and tissue was inadequate in one subject. Delayed graft function (DGF was observed in 3 patients; 2 with vascular changes in PIB, and one with normal histopathological findings. Two subjects with PIB changes lost their grafts. The estimated glomerular filtration rate at 3-, and 6-months post-transplantation was lower in children with abnormal PIB changes compared with those with normal PIB. There was one case of DGF in the control group, and 4 children lost their grafts including the one with DGF. Conclusion: Pre-implantation renal biopsy can provide important baseline information of the graft with implications on subsequent medical treatment for pediatric renal transplant recipients.

  12. Correlative analyze of predictable factors of successful implantation in assisted reproduction programme

    Directory of Open Access Journals (Sweden)

    Papić-Obradović Milena

    2003-01-01

    Full Text Available INTRODUCTION Endometrial receptivity as isolated predictive factor of successful implantation, with its specifity is determined with numbered factors. PURPOSE Purpose of this study was to evaluate significance and correlation between relevant factors using appropriate statistical analyses on term of embryo implantation. MATERIAL AND METHODS Evaluated group contained 85 women whom according different causes of infertility have been determined for assisted reproduction program. Analysed measurements were endometrial thickness, assessed hyperechogenity in relation with absolute endometrial thickness (HEA relation and uterine blood flow (pulsatile index - Pi. Simultaneously were analyzed serum estradiol (E2; pg/ml and progesteron (P; nmol/l levels. After these evaluations achieved results were processed with standard statistical pack. Beside that were applied parameter and nonparameter tests with aim to test significancy of difference and multiple regressive analyse (Stepwise. RESULTS Resulted measured parameters have been presented in basic analyse as middle value (Xrs from all measurements +SD (standard deviation and significance of difference is tested by mentioned statistical tests (Table 1. Application of Stepwise analyse, "step by step", has used parameter by parameter based on value which has decreased variability and based on achieved correlative coefficient between dependent uneven and complex of independent uneven values. This procedure confirmes best correlation between HEA relation and serum progesteron levels and HEA relation in correlation with associated values: P, E2 and endometrial thickness (Table 1. DISCUSSION Investigation provided till now shows that embryo quality and endometrial receptivity with highest probability determine success of applied assisted reproduction, successful embryonal implantation There is assessed influence of endometrial receptivity represented trough HEA relation using manyfolded regressive analyse where

  13. Comparison of bare metal stenting and percutaneous pulmonary valve implantation for treatment of right ventricular outflow tract obstruction: use of an x-ray/magnetic resonance hybrid laboratory for acute physiological assessment.

    Science.gov (United States)

    Lurz, Philipp; Nordmeyer, Johannes; Muthurangu, Vivek; Khambadkone, Sachin; Derrick, Graham; Yates, Robert; Sury, Michael; Bonhoeffer, Philipp; Taylor, Andrew M

    2009-06-16

    Treatment of right ventricular outflow tract obstruction is possible with a bare metal stent (BMS), although this treatment causes pulmonary regurgitation. In this study, we assessed the acute physiological effects of BMS versus percutaneous pulmonary valve implantation (PPVI) using an x-ray/magnetic resonance hybrid laboratory. Fourteen consecutive children (median age, 12.9 years) with significant right ventricular outflow tract obstruction underwent BMS followed by PPVI. Magnetic resonance imaging (ventricular volumes and function and great vessel blood flow) and hemodynamic assessment (invasive pressure measurements) were performed before BMS, after BMS, and after PPVI; all were performed under general anesthesia in an x-ray/magnetic resonance hybrid laboratory. BMS significantly reduced the ratio of right ventricular to systemic pressure (0.75+/-0.17% versus 0.41+/-0.14%; Phybrid laboratory, we have demonstrated the superior acute hemodynamic effects of PPVI over BMS in patients with right ventricular outflow tract obstruction.

  14. Perioperative management of a patient with Dandy Walker malformation with tetralogy of Fallot undergoing total correction and fresh homologous pericardial pulmonary valve conduit implantation: Report of a rare case

    Directory of Open Access Journals (Sweden)

    Vishnu Datt

    2015-01-01

    Full Text Available Perioperative management of a patient with Dandy-Walker malformation (DWM with tetralogy of Fallot (TOF, patent ductus arteriosus, and pulmonary artery stenosis is a great challenge to the anesthesiologist. Anesthetic management in such patients can trigger tet spells that might rapidly increase intracranial pressure (ICP, conning and even death. The increase in ICP can precipitate tet spells and further brain hypoxia. To avoid an increase in ICP during TOF corrective surgery ventriculo-peritoneal (VP shunt should be performed before cardiac surgery. We present the first case report of a 11-month-old male baby afflicted with DWM and TOF who underwent successful TOF total corrective surgery and fresh autologous pericardial pulmonary valve conduit implantation under cardiopulmonary bypass after 1 week of VP shunt insertion.

  15. Perioperative management of a patient with Dandy Walker malformation with tetralogy of Fallot undergoing total correction and fresh homologous pericardial pulmonary valve conduit implantation: Report of a rare case.

    Science.gov (United States)

    Datt, Vishnu; Tempe, D K; Lalwani, Parin; Aggarwal, Saket; Kumar, Pradeep; Diwakar, Anitha; Tomar, A S

    2015-01-01

    Perioperative management of a patient with Dandy-Walker malformation (DWM) with tetralogy of Fallot (TOF), patent ductus arteriosus, and pulmonary artery stenosis is a great challenge to the anesthesiologist. Anesthetic management in such patients can trigger tet spells that might rapidly increase intracranial pressure (ICP), conning and even death. The increase in ICP can precipitate tet spells and further brain hypoxia. To avoid an increase in ICP during TOF corrective surgery ventriculo-peritoneal (VP) shunt should be performed before cardiac surgery. We present the first case report of a 11-month-old male baby afflicted with DWM and TOF who underwent successful TOF total corrective surgery and fresh autologous pericardial pulmonary valve conduit implantation under cardiopulmonary bypass after 1 week of VP shunt insertion.

  16. Prediction of Polyethylene Wear Rates from Gait Biomechanics and Implant Positioning in Total Hip Replacement.

    Science.gov (United States)

    Ardestani, Marzieh M; Amenábar Edwards, Pedro P; Wimmer, Markus A

    2017-08-01

    Patient-specific gait and surgical variables are known to play an important role in wear of total hip replacements (THR). However a rigorous model, capable of predicting wear rate based on a comprehensive set of subject-specific gait and component-positioning variables, has to our knowledge, not been reported. (1) Are there any differences between patients with high, moderate, and low wear rate in terms of gait and/or positioning variables? (2) Can we design a model to predict the wear rate based on gait and positioning variables? (3) Which group of wear factors (gait or positioning) contributes more to the wear rate? Data on patients undergoing primary unilateral THR who performed a postoperative gait test were screened for inclusion. We included patients with a 28-mm metal head and a hip cup made of noncrosslinked polyethylene (GUR 415 and 1050) from a single manufacturer (Zimmer, Inc). To calculate wear rates from radiographs, inclusion called for patients with a series of standing radiographs taken more than 1 year after surgery. Further, exclusion criteria were established to obtain reasonably reliable and homogeneous wear readings. Seventy-three (83% of included) patients met all criteria, and the final dataset consisted of 43 males and 30 females, 69 ± 10 years old, with a BMI of 27.3 ± 4.7 kg/m(2). Wear rates of these patients were determined based on the relative displacement of the femoral head with regard to the cup using a validated computer-assisted X-ray wear-analysis suite. Three groups with low ( 0.2 mm/year) wear were established. Wear prediction followed a two-step process: (1) linear discriminant analysis to estimate the level of wear (low, moderate, or high), and (2) multiple linear and nonlinear regression modeling to predict the exact wear rate from gait and implant-positioning variables for each level of wear. There were no group differences for positioning and gait suggesting that wear differences are caused by a combination of wear

  17. Prediction of STN-DBS Electrode Implantation Track in Parkinson's Disease by Using Local Field Potentials.

    Science.gov (United States)

    Telkes, Ilknur; Jimenez-Shahed, Joohi; Viswanathan, Ashwin; Abosch, Aviva; Ince, Nuri F

    2016-01-01

    Optimal electrophysiological placement of the DBS electrode may lead to better long term clinical outcomes. Inter-subject anatomical variability and limitations in stereotaxic neuroimaging increase the complexity of physiological mapping performed in the operating room. Microelectrode single unit neuronal recording remains the most common intraoperative mapping technique, but requires significant expertise and is fraught by potential technical difficulties including robust measurement of the signal. In contrast, local field potentials (LFPs), owing to their oscillatory and robust nature and being more correlated with the disease symptoms, can overcome these technical issues. Therefore, we hypothesized that multiple spectral features extracted from microelectrode-recorded LFPs could be used to automate the identification of the optimal track and the STN localization. In this regard, we recorded LFPs from microelectrodes in three tracks from 22 patients during DBS electrode implantation surgery at different depths and aimed to predict the track selected by the neurosurgeon based on the interpretation of single unit recordings. A least mean square (LMS) algorithm was used to de-correlate LFPs in each track, in order to remove common activity between channels and increase their spatial specificity. Subband power in the beta band (11-32 Hz) and high frequency range (200-450 Hz) were extracted from the de-correlated LFP data and used as features. A linear discriminant analysis (LDA) method was applied both for the localization of the dorsal border of STN and the prediction of the optimal track. By fusing the information from these low and high frequency bands, the dorsal border of STN was localized with a root mean square (RMS) error of 1.22 mm. The prediction accuracy for the optimal track was 80%. Individual beta band (11-32 Hz) and the range of high frequency oscillations (200-450 Hz) provided prediction accuracies of 72 and 68% respectively. The best prediction

  18. ROC Based Evaluation and Comparison of Classifiers for IVF Implantation Prediction

    Science.gov (United States)

    Uyar, Asli; Bener, Ayse; Ciray, H. Nadir; Bahceci, Mustafa

    Determination of the best performing classification method for a specific application domain is important for the applicability of machine learning systems. We have compared six classifiers for predicting implantation potentials of IVF embryos. We have constructed an embryo based dataset which represents an imbalanced distribution of positive and negative samples as in most of the medical datasets. Since it is shown that accuracy is not an appropriate measure for imbalanced class distributions, ROC analysis have been used for performance evaluation. Our experimental results reveal that Naive Bayes and Radial Basis Function methods produced significantly better performance with (0.739 ± 0.036) and (0.712 ± 0.036) area under the curve measures respectively.

  19. Implante transapical de endoprótese valvada balão-expansível em posição aórtica sem circulação extracorpórea Off-pump transapical balloon-expandable aortic valve endoprosthesis implantation

    Directory of Open Access Journals (Sweden)

    Diego Felipe Gaia

    2009-06-01

    ão.OBJECTIVE: The aortic valve replacement is a routine procedure, and involves replacement of the native valve/prosthesis. In most of the patients who undergo such procedure the risk is acceptable, but in some cases, such risk can justify contraindication. The minimally invasive transcatheter aortic valve implantation without cardiopulmonary bypass (CPB has been shown to be viable, with lower morbidity and mortality. The aim of this study was to develop a catheter-mounted aortic bioprosthesis for implantation without CPB. METHODS: After developing in animals, three patients with high EuroSCORE underwent implantation. Case 1: patients with bioprosthesis dysfunction; Case 2: severe aortic stenosis; Case 3: dysfunction of aortic bioprosthesis. After minithoracotomy and under echocardiographic and fluoroscopic control, a balloon catheter was placed on aortic position and inflated. After, a second balloon with valved endoprosthesis was positioned and released under high ventricular rate. Echocardiographic and angiographic controls were performed and the patients were referred to ICU. RESULTS: In the first case, implantation without CPB was possible with appropriate results. The patient evolved with improvement of ventricular function. After, this patient developed bronchopneumonia, tracheoesophageal fistula and died due to mediastinitis. Autopsy confirmed proper valve positioning and leaflets preservation. The second case showed the device migration after inflation of the balloon, with the need for urgent median sternotomy, CPB and conventional valve replacement. This patient evolved well and was discharged from the ICU on the 14th postoperative day without complications. This patient developed respiratory infection, septic shock and died on the 60th postoperative day. The patient from the third case underwent successful implantation. CONCLUSION: The off-pump transapical implantation of catheter-mounted bioprosthesis was shown to be a feasible procedure. Technical details and learning

  20. Localization in reverberation with cochlear implants: predicting performance from basic psychophysical measures.

    Science.gov (United States)

    Kerber, Stefan; Seeber, Bernhard U

    2013-06-01

    Users of bilateral cochlear implants (CIs) experience difficulties localizing sounds in reverberant rooms, even in rooms where normal-hearing listeners would hardly notice the reverberation. We measured the localization ability of seven bilateral CI users listening with their own devices in anechoic space and in a simulated reverberant room. To determine factors affecting performance in reverberant space we measured the sensitivity to interaural time differences (ITDs), interaural level differences (ILDs), and forward masking in the same participants using direct computer control of the electric stimulation in their CIs. Localization performance, quantified by the coefficient of determination r(2) and the root mean squared error, was significantly worse in the reverberant room than in anechoic conditions. Localization performance in the anechoic room, expressed as r(2), was best predicted by subject's sensitivity to ILDs. However, the decrease in localization performance caused by reverberation was better predicted by the sensitivity to envelope ITDs measured on single electrode pairs, with a correlation coefficient of 0.92. The CI users who were highly sensitive to envelope ITDs also better maintained their localization ability in reverberant space. Results in the forward masking task added only marginally to the predictions of localization performance in both environments. The results indicate that envelope ITDs provided by CI processors support localization in reverberant space. Thus, methods that improve perceptual access to envelope ITDs could help improve localization with bilateral CIs in everyday listening situations.

  1. Success and High Predictability of Intraorally Welded Titanium Bar in the Immediate Loading Implants

    National Research Council Canada - National Science Library

    Fogli, Vaniel; Camerini, Michele; Lauritano, Dorina; Carinci, Francesco

    2014-01-01

    .... This concept is especially true in case of implants placed in atrophic ridges. So the primary stabilization and fixation of implants are an important goal that can also allow immediate loading and oral rehabilitation on the same day of surgery...

  2. Success and high predictability of intraorally welded titanium bar in the immediate loading implants

    National Research Council Canada - National Science Library

    Fogli, Vaniel; Camerini, Michele; Lauritano, Dorina; Carinci, Francesco

    2014-01-01

    .... This concept is especially true in case of implants placed in atrophic ridges. So the primary stabilization and fixation of implants are an important goal that can also allow immediate loading and oral rehabilitation on the same day of surgery...

  3. Predicting Implantation Outcome of In Vitro Fertilization and Intracytoplasmic Sperm Injection Using Data Mining Techniques.

    Science.gov (United States)

    Hafiz, Pegah; Nematollahi, Mohtaram; Boostani, Reza; Namavar Jahromi, Bahia

    2017-10-01

    In vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) are two important subsets of the assisted reproductive techniques, used for the treatment of infertility. Predicting implantation outcome of IVF/ICSI or the chance of pregnancy is essential for infertile couples, since these treatments are complex and expensive with a low probabili