WorldWideScience

Sample records for valve implantation initial

  1. Remote actuated valve implant

    Science.gov (United States)

    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.

  2. Remote actuated valve implant

    Energy Technology Data Exchange (ETDEWEB)

    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.

  3. 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.

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

    Science.gov (United States)

    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

  5. 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

  6. 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.

  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. 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...

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

    Science.gov (United States)

    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.

  11. 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...

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

    Science.gov (United States)

    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.

  13. 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 ...

  14. 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.

  15. 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

  16. 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.

  17. Transcatheter aortic valve implantation and cerebrovascular accidents.

    Science.gov (United States)

    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.

  18. 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

  19. 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...

  20. 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.

  1. 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.

  2. 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

  3. 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 ...

  4. 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.

  5. 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.

  6. 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...

  7. 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

  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. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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...

  6. 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.

  7. 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....

  8. [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.

  9. 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.

  10. 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.

  11. 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.

  12. 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...

  13. 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...

  14. 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.

  15. 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....

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. 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

  4. 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...

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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

  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. Subcutaneous implantable cardioverter-defibrillator: Initial experience.

    Science.gov (United States)

    Galvão, Pedro; Cavaco, Diogo; Adragão, Pedro; Costa, Francisco; Carmo, Pedro; Morgado, Francisco; Bernardo, Ricardo; Nunes, Manuela; Abecasis, Miguel; Neves, José; Mendes, Miguel

    2014-09-01

    Implantable cardioverter-defibrillators (ICDs) are important tools in the prevention of sudden death, but implantation requires transvenous access, which is associated with complications. Subcutaneous implantable cardioverter-defibrillators (S-ICDs) may prevent some of these complications. To evaluate the therapeutics and complications associated with S-ICD systems. S-ICD implantation was planned in 23 patients, for whom the indications were vascular access problems, increased risk of infection or young patients with long predicted follow-up. The population consisted of four patients with ischemic heart disease, three of them on hemodialysis (two with subclavian vein thrombosis), five with left ventricular noncompaction, four with Brugada syndrome, three with arrhythmogenic right ventricular cardiomyopathy, one with transposition of the great vessels, two with dilated cardiomyopathy and four with hypertrophic cardiomyopathy. S-ICDs were implanted in 21 patients, two having failed to fulfil the initial screening criteria. Mean implantation time was 77 minutes, with no complications. Defibrillation tests were performed, and in one patient the generator had to be repositioned to obtain an acceptable threshold. In a mean follow-up of 14 months, 10 patients had S-ICD shocks, which were appropriate in half of them; one developed infection, one needed early replacement due to loss of telemetry and one patient died of noncardiac cause. S-ICD implantation can be performed by cardiologists with a high success rate. Initial experience appears favorable, but further studies are needed with longer follow-up times to assess the safety and efficacy of this strategy compared to conventional devices. Copyright © 2013 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  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. 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.

  13. 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.

  14. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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.

  1. 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...

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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...

  9. 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.

  10. 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.

  11. [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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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,

  13. Prevention of crack initiation in valve bodies under thermal shock

    Energy Technology Data Exchange (ETDEWEB)

    Delmas, J.; Coppolani, P.

    1996-12-01

    On site and testing experience has shown that cracking in valves affects mainly the stellite hardfacing on seats and discs but may also be a concern for valve bodies. Metallurgical investigations conducted by EDF laboratories on many damaged valves have shown that most of the damage had either a chemical, manufacturing, or operating origin with a strong correlation between the origins and the type of damage. The chemical defects were either excess ferritic dilution of stellite or excess carburizing. Excess carburizing leads to a too brittle hardfacing which cracks under excessive stresses induced on the seating surfaces, via the stem, by too high operating thrusts. The same conditions can also induce cracks of the seats in the presence, in the hardfacing, of hidden defects generated during the welding process. Reduction of the number of defects results first from controls during manufacturing, mainly in the thickness of stellite. On the other hand, maintenance must be fitted to the type of defect. In-situ lapping may lead to release of cobalt, resulting in contamination of the circuit. Furthermore, it is ineffectual in the case of a crack through the seating surface, as is often found on globe valves. The use of new technologies of valves with removable seats and cobalt-free alloys solves permanently this kind of problem.

  14. 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

  15. 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%.

  16. 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...

  17. 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.

  18. 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.

  19. 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...

  20. 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.

  1. [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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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...

  7. 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

  8. Initial Experience with Sutureless Sorin Perceval S Aortic Prosthesis for the Treatment of Prosthetic Valve Endocarditis.

    Science.gov (United States)

    Lio, Antonio; Miceli, Antonio; Solinas, Marco; Glauber, Mattia

    2015-09-01

    The objective of this study is to evaluate results of the initial experience with sutureless Perceval S for active prosthetic valve endocarditis (PVE). From October 2012 to April 2014, f: ve patients underwent surgery for aortic PVE with Perceval S bioprosthesis. There was one in-hospital death (20%). Echocardiography performed at discharge showed excellent hemodynamic performance of Perceval S bioprosthesis. Aortic valve replacement with Perceval S sutureless valve in patients with PVE is a feasible and safe procedure, associated with low in-hospital mortality and good hemodynamic performance of the prosthesis. Georg Thieme Verlag KG Stuttgart · New York.

  9. 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.

  10. 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.

  11. 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.

  12. Initial Surgical Experience with Aortic Valve Repair: Clinical and Echocardiographic Results

    Science.gov (United States)

    da Costa, Francisco Diniz Affonso; Colatusso, Daniele de Fátima Fornazari; da Costa, Ana Claudia Brenner Affonso; Balbi Filho, Eduardo Mendel; Cavicchioli, Vinicius Nesi; Lopes, Sergio Augusto Veiga; Ferreira, Andrea Dumsch de Aragon; Collatusso, Claudinei

    2016-01-01

    Introduction Due to late complications associated with the use of conventional prosthetic heart valves, several centers have advocated aortic valve repair and/or valve sparing aortic root replacement for patients with aortic valve insufficiency, in order to enhance late survival and minimize adverse postoperative events. Methods From March/2012 thru March 2015, 37 patients consecutively underwent conservative operations of the aortic valve and/or aortic root. Mean age was 48±16 years and 81% were males. The aortic valve was bicuspid in 54% and tricuspid in the remaining. All were operated with the aid of intraoperative transesophageal echocardiography. Surgical techniques consisted of replacing the aortic root with a Dacron graft whenever it was dilated or aneurysmatic, using either the remodeling or the reimplantation technique, besides correcting leaflet prolapse when present. Patients were sequentially evaluated with clinical and echocardiographic studies and mean follow-up time was 16±5 months. Results Thirty-day mortality was 2.7%. In addition there were two late deaths, with late survival being 85% (CI 95% - 68%-95%) at two years. Two patients were reoperated due to primary structural valve failure. Freedom from reoperation or from primary structural valve failure was 90% (CI 95% - 66%-97%) and 91% (CI 95% - 69%-97%) at 2 years, respectively. During clinical follow-up up to 3 years, there were no cases of thromboembolism, hemorrhage or endocarditis. Conclusions Although this represents an initial series, these data demonstrates that aortic valve repair and/or valve sparing aortic root surgery can be performed with satisfactory immediate and short-term results. PMID:27556321

  13. 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.)

  14. 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...

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. Initial Experience with Elective Perventricular Melody Valve Placement in Small Patients.

    Science.gov (United States)

    Gupta, Aamisha; Kenny, Damien; Caputo, Massimo; Amin, Zahid

    2017-03-01

    Perventricular Melody valve placement has been described as a bailout approach or alternative RVOT approach in patients >30 kg. We present three patients hybrid pulmonary valve replacement were reviewed. The subcostal approach was performed without sternotomy with the sheath introduced through the diaphragmatic surface of the right ventricle. Diagnoses included tetralogy of Fallot (n = 3) and truncus arteriosus (n = 2). Mean weight was 16.2 kg (range 4.7-28.1 kg). Four patients had RV-PA conduits (size: 14-21 mm), and the fifth patient had a transannular patch. All patients met criteria for surgical valve replacement. Technical success was 100%. In two patients with absent pulmonary valve, the stent migrated during advancement of the delivery sheath. These stents were anchored in the distal main pulmonary artery (n = 1) or branch pulmonary artery (n = 1) without sequela. Tricuspid valve chordal injury occurred in one patient, where transesophageal echocardiogram (TEE) was not utilized. No patient required conversion to cardiopulmonary bypass. One patient with absent pulmonary valve died on follow-up as a consequence of severe airway compromise. Our initial experience demonstrates that the perventricular valve can be placed safely in small-sized patients. Advancement of the melody ensemble may be difficult and may cause stent migration. We conclude that the technique is feasible in small-sized patients and that prevention of complications includes placement of the stent at the time of the valve and TEE assistance in reducing tricuspid valve injury.

  1. 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.

  2. 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.

  3. 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...

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

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

    Science.gov (United States)

    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).

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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.

  2. 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.

  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. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

  8. Outcome of surgical implant generation network nail initiative in ...

    African Journals Online (AJOL)

    Background: Closed interlocked intra-medullary nailing (IM), the standard method of treating of long bone shaft fracture, has been a dream to most resource poor hospitals like Kenyan regional hospitals. Surgical implant generation network (SIGN) initiative employs use of external jigs and slot finders instead of expensive ...

  9. 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.

  10. 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.

  11. [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.

  12. 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.

    Science.gov (United States)

    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.

  13. 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.

  14. 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

  15. 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.

  16. 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...

  17. 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.

  18. 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.

  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. 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.

  1. 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.

  2. 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...

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Initial hydrodynamic study on a new intraaortic axial flow pump: Dynamic aortic valve.

    Science.gov (United States)

    Li, G; Zhao, H; Hu, S; Zhu, X; Wu, Q; Ren, B; Ma, W

    2001-04-01

    Rotary blood pumps have been researched as implantable ventricular assist devices for years. To further reduce the complex of implanted axial pumps, the authors proposed a new concept of intraaortic axial pump, termed previously as "dynamic aortic valve (DAV)". Instead of being driven by an intraaortic micro-electric motor, it was powered by a magnetic field from outside of body. To ensure the perfusion of coronary artery, the axial flow pump is to be implanted in the position of aortic valve. It could serve as either a blood pump or a mechanical valve depending on the power input. This research tested the feasibility of the new concept in model study. A column, made from permanent magnet, is jointed to an impeller in a concentric way to form a "rotor-impeller". Supported by a hanging shaft cantilevered in the center of a rigid cage, the rotor-impeller can be turned by the magnetic field in the surrounding space. In the present prototype, the rotor is 8 mm in diameter and 15 mm in length, the impeller has 3 vanes with an outer diameter of 18 mm. The supporting cage is 22 mm in outer diameter and 20 mm in length. When tested, the DAV prototype is inserted into the tube of a mock circuit. The alternative magnetic field is produced by a rotating magnet placed side by side with the rotor-impeller at a distance of 30 mm. Once the alternative magnetic field is presented in the surrounding space, the DAV starts to turn, leading to a pressure difference and liquid flow in the tube. The flow rate or pressure difference is proportioned to rotary speed. At the maximal output of hydraulic power, the flow rate reached 5 L/min against an afterload of 100 mmHg. The maximal pressure difference generated by DAV at a rotation rate of 12600 r/min was 147 mmHg. The preliminary results demonstrated the feasibility of "DAV", further research on this concept is justifiable.

  14. 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.

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. [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.

  9. 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.

  10. 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.

  11. 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.

  12. ECG-gated multi-detector row CT for assessment of mitral valve disease: initial experience

    Energy Technology Data Exchange (ETDEWEB)

    Willmann, Juergen K.; Roos, Justus E.; Hilfiker, Paul R.; Marincek, Borut; Weishaupt, Dominik [Institute of Diagnostic Radiology, University Hospital Zurich, Raemistrasse 100, 8091 Zurich (Switzerland); Kobza, Richard; Jenni, Rolf; Luescher, Thomas F. [Clinic of Cardiology, University Hospital Zurich, Raemistrasse 100, 8091 Zurich (Switzerland); Lachat, Mario [Clinic of Cardiovascular Surgery, University Hospital Zurich, Raemistrasse 100, 8091 Zurich (Switzerland)

    2002-11-01

    Our objective was to evaluate applicability and image quality of contrast-enhanced, retrospectively ECG-gated multi-detector row CT (MDCT) for visualization of anatomical details of the mitral valve and its apparatus, and to determine the value of MDCT for diagnosing abnormal findings of the mitral valve. Twenty consecutive patients with mitral valve disease underwent MDCT preoperatively. Two readers assessed visibility of the mitral valve annulus, mitral valve leaflets, tendinous cords, and papillary muscles by using a four-point Likert grading scale. Abnormal mitral valve findings [thickening of the mitral valve leaflets, presence of mitral annulus calcification (MAC), and calcification of the valvular leaflets] were compared with preoperative echocardiography and intraoperative findings. Visibility of the mitral valve annulus and mitral valve leaflets was good or excellent in 15 patients (75%) and in 19 patients (95%) for papillary muscles. The MDCT yielded a 95-100% agreement compared with echocardiography and surgery with regard to the assessment of mitral valve leaflet thickening and the presence of calcifications of the mitral valve annulus or mitral valve leaflets. Intermodality agreement between MDCT and echocardiography was excellent with regard to classification of mitral valve leaflet thickness ({kappa}=1.00) and good regarding classification of MAC thickness ({kappa}=0.73). Contrast-enhanced, retrospectively ECG-gated MDCT allows good to excellent visualization of anatomical details of the mitral valve and its apparatus, and demonstrates good agreement with echocardiography and surgery in diagnosing mitral valve abnormalities. (orig.)

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. Tissue Heart Valve Replacement at BSMMU- Initial Experience with Two Cases

    Directory of Open Access Journals (Sweden)

    Rezwanul Hoque

    2010-07-01

    Full Text Available Research on prosthesis to replace diseased heart valves began almost simultaneously with mechanical valves which aredurable but with inherent thromboembolic complication requiring life-long anticoagulant therapy and tissue valves whichare more prone to structural failure but free from thromboembolic complication. Tissue valves are more useful in females ofreproductive age desiring a child, male patients older than 60 years of age and female patients over 55 years of age, patientshaving chronic liver disease, history of stroke, bleeding disorder and in presence of infective endocarditis. Gluteraldehydefixation at low pressure with removal of maximal amount of phospholipid have increased the durability of tissue valves inrecent years. Considering the better quality of life with tissue valve the trend is shifting towards using it more frequentlyaround the world. Recently two heart valve replacement operations using bovine perimount pericardial valve were done inthe department of cardiac surgery, BSMMU, one in aortic position another in mitral position, both in females of reproductiveage desiring children.The operations were technically demanding but the outcomes were uneventful. Tissue heart valvereplacement is a safe procedure and can be useful in female of child bearing age desiring children.Key Words: Tissue heart valve replacement; Aortic valve; Mitral valve; Bioprosthetic heart valves; Bovine perimountpericardial valve.DOI: 10.3329/bsmmuj.v3i1.5511BSMMU J 2010; 3(1: 27-30

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. Initial Experience With the New Ahmed Glaucoma Valve Model M4: Short-term Results.

    Science.gov (United States)

    Cvintal, Victor; Moster, Marlene R; Shyu, Andrew P; McDermott, Katie; Ekici, Feyzahan; Pro, Michael J; Waisbourd, Michael

    2016-05-01

    To evaluate the clinical outcomes of the new Ahmed glaucoma valve (AGV) model M4. The device consists of a porous polyethylene shell designed for improved tissue integration and reduced encapsulation of the plate for better intraocular pressure (IOP) control. Medical records of patients with an AGV M4 implantation between December 1, 2012 and December 31, 2013 were reviewed. The main outcome measure was surgical failure, defined as either (1) IOP21 mm Hg and/or IOP at last follow-up visit, (2) a reoperation for glaucoma, and/or (3) loss of light perception. Seventy-five eyes of 73 patients were included. Postoperative IOP at all follow-up visits significantly decreased from a baseline IOP of 31.2 mm Hg (PIOP increased significantly at 3 months (20.4 mm Hg), 6 months (19.3 mm Hg), and 12 months (20.3 mm Hg) compared with 1 month (13.8 mm Hg) postoperatively (PIOP in the first postoperative month, but IOP steadily increased thereafter. Consequently, failure rates were high after 1 year of follow-up.

  5. Symetis Acurate Transapical Aortic Valve: the initial experience with a second generation of transcatheter aortic valve replacement device.

    Science.gov (United States)

    Zembala, Michał Oskar; Piegza, Jacek; Wacławski, Jacek; Hawranek, Michał; Hilker, Michael; Niklewski, Tomasz; Głowacki, Jan; Parys, Monika; Nadziakiewicz, Paweł; Chodór, Piotr; Wilczek, Krzysztof; Przybylski, Roman; Gąsior, Mariusz; Zembala, Marian

    2014-01-01

    Transcatheter aortic valve replacement (TAVR) has proven to be a valuable alternative to conventional surgical aortic valve replacement in high risk and surgically in operable patients who suffer from severe symptomatic aortic stenosis. However, a significant number of complications, associated with both the learning curve and device specificity, have required attention and subsequent improvement. The Symetis transapical TAVR system is a self-positioning bioprosthesis composed of a non-coronary leaflet of surgical quality porcine tissue valve sewn into a self-expanding nitinol stent that iscovered with a PET-skirt. From June to September 2013 six patients have been operated on severe aortic stenosis using the new TAVR device. All patients have undergone critical assessment of a local Heart Team and have been disqualified from conventional AVR. Five were woman. Mean age was 82.3 ± 2.0 (mean LogEuroScore 23.9 ± 14.3). Four patients suffered from coronary artery disease - two had history of previous percutaneous coronary intervention with intracoronary stents, while the next two had history of coronary artery bypass grafting. Diabetes was frequent (n = 3) as well as chronic obstructive pulmonary disease (n = 4). Carotid artery disease was encountered in three patients similarly to atrial fibrillation. Mean left ventricular ejection fraction (LVEF) was 51.5 ± 11.8%, but one patient had suffered from low-flow-low-gradient aortic stenosis with LVEF of 29%. The procedure was carried out successfully in all six cases. Two patients have received the valve sized L, three - M and one - S. Mean procedure time was 180 ± 19 min, mean cine 7.2 ± 1.2 min. Mean X-ray dose 930 ± 439 mGy, while mean volume of contrast given was 135 ± 61 mL. In all patients but one perivalvular leak (PVL) was not present. One patient had trace of PVL. Also, good LVEF was noted in all patients. Similar findings were obtained 30 days post procedure. No strokes, transient ischaemic attack or other

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. [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.

  12. 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.

  13. 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...

  14. 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

  15. 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.)

  16. 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.

  17. 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.

  18. 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

  19. 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.

  20. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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

    . CONCLUSION: The initial experience with percutaneous aortic valve implantation under general anesthesia has proven to be safe and effective, with no significant anesthetic complications during this procedure.

  5. Timing of anticoagulant re-initiation following intracerebral hemorrhage in mechanical heart valves: Survey of neurosurgeons and thrombosis experts.

    Science.gov (United States)

    AlKherayf, Fahad; Xu, Yan; Westwick, Harrison; Moldovan, Ioana Doina; Wells, Philip S

    2017-03-01

    While oral anticoagulation (OAC) is universally indicated for patients with mechanical heart valves (MHVs), OAC resumption following anticoagulant-associated intracerebral hemorrhage (ICH) is an area of uncertainty. We sought to determine the practice preferences of North American neurosurgeons and thrombosis experts on optimal timing of OAC re-initiation. A cross-sectional survey was disseminated to North American members of the American Association of Neurological Surgeons and the International Society for Thrombosis and Haemostasis. Demographic factors, as well as a clinical scenario with 14 modifiable clinical risk factors were included in the survey. 504 physicians completed our survey (response rate 34.3%). Majority of participants were affiliated with academic centres, and managed≤10 ICH patients with MHV per year. There was wide distribution in response in optimal timing for OAC resumption following an ICH: 59% and 60% preferred to re-start OAC between 3 and 14 days following the hemorrhagic event (median of 6-7 days). Smaller hemorrhages (valve prosthesis, caged-ball valves and multiple valves prompted earlier OAC resumption. Wide variation in the current practice of neurosurgeons and thrombosis specialists exist when they encounter patients with ICH and MHV, though decisions were influenced by patient- and valve-related factors. As our observed variation likely reflects the immense gap in current evidence, prospective randomized trials in this population are therefore urgently needed. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. 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.

  7. 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...

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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....

  19. Initiation of Targeted Nanodrug Delivery in Vivo by a Multifunctional Magnetic Implant.

    Science.gov (United States)

    Ge, Jianhua; Zhang, Yi; Dong, Zhirui; Jia, Jianbo; Zhu, Jiannan; Miao, Xiaoyuan; Yan, Bing

    2017-06-21

    Implant-mediated targeted drug delivery without an external magnetic field is very challenging. In this work, we report targeted nanodrug delivery initiated by a Fe3O4/poly(lactic-co-glycolic acid) implant scaffold with high magnetism. The implant scaffold is biocompatible and durable. It effectively attracts nanodrugs to its surface, thus killing cancer cells. These findings provide a proof of concept for the magnetic implant-directed nanodrug targeting without the need for an external magnetic field. This approach may further facilitate more precise medical treatments.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Cardiac remodeling following percutaneous mitral valve repair - initial results assessed by cardiovascular magnetic resonance imaging

    DEFF Research Database (Denmark)

    Radunski, U K; Franzen, O; Barmeyer, A

    2014-01-01

    (CMR) to assess reverse myocardial remodeling in patients after MitraClip implantation. MATERIALS AND METHODS: 12 patients underwent CMR at baseline (BL) before and at 6 months follow-up (FU) after MitraClip implantation. Cine-CMR was performed in short- and long-axes for the assessment of left...

  9. 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.

  10. 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

  11. Ventricular tachycardia initiated by high energy cardioversion in a patient with an implantable cardioverter defibrillator.

    OpenAIRE

    Chinushi, M.; Aizawa, Y; Higuchi, K.

    1997-01-01

    A transvenous implantable cardioverter defibrillator (ICD) was implanted into a 58 year old woman with idiopathic dilated cardiomyopathy who had drug refractory monomorphic ventricular tachycardia (VT). Antitachycardia pacing failed to terminate the VT; termination was attempted at 24 J, which was above the defibrillation threshold. When cardioversion at 24 J was delivered, VT with a different morphology and slower rate was reproducibly initiated. At 3 J, however, the original VT was successf...

  12. 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.

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

    Science.gov (United States)

    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.

  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. 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.

  17. 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.

  18. 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.

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

    Science.gov (United States)

    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.

  20. Implantation of a new access device for hemodialysis (Dialock): initial experience in 5 patients

    Energy Technology Data Exchange (ETDEWEB)

    Schmitz-Rode, T.; Buecker, A.; Tacke, J.; Wingen, M.; Guenther, R.W. [Dept. of Diagnostic Radiology, Universitaetsklinikum der RWTH Aachen (Germany); Noah, M. [Dept. of Plastic Surgery, Universitaetsklinikum der RWTH Aachen (Germany); Ketteler, M. [Dept. of Nephrology, Universitaetsklinikum der RWTH Aachen (Germany)

    2001-06-01

    A new hemodialysis access port system was implanted. Methods: The Dialock{sup TM} consists of a port-like double-valve, implanted subcutaneously below the clavicle, which is attached to two catheters, placed in the right atrium via the jugular vein. The device has been implanted in 5 patients (4 female, 1 male). Results: In all 5 patients the implantation of the catheters and the port was technically successful. Total average duration of dialysis was 3.6 months. Two patients developed a port pocket hematoma 10-14 days post implantation, one of them required surgical revision. One port was explanted due to septicemia, whereas a port infection was not confirmed. One patient showed a thrombotic occlusion of both catheter tips 8 days after implantation, fixed by catheter exchange. Another patient presented with slight migration of the port catheters, which was managed by refixation of the port within the pocket. Beside these complications, the devices were working well. Conclusion: The Dialock system offers an interesting alternative to external catheters for hemodialysis. With respect to the complications it deserves further studies to determine its future role in the field of vascular access. (orig.) [German] Ein neues Haemodialyse-Portsystem wurde klinisch erprobt. Methoden: Das Dialock{sup TM}-System besteht aus einem Doppelventil-Port, der subkutan unterhalb der Klavikel implantiert wird. An den Port sind zwei Katheter angeschlossen, die subkutan getunnelt transjugulaer im rechten Vorhof platziert werden. Das System wurde in 5 Patienten implantiert (4 Frauen, 1 Mann). Ergebnisse: Bei allen 5 Patienten war die Katheter- und Portimplantation technisch erfolgreich. Die bisherige mittlere Dialyse-Dauer betraegt 3,6 Monate. Bei zwei Patienten bildete sich ein Haematom der Porttasche 10-14 Tage nach der Implantation. In einem Fall war eine operative Ausraeumung erforderlich. Ein Patient entwickelte eine Sepsis, worauf das Portsystem explantiert wurde. Eine Portinfektion

  1. Implantable cardioverter defibrillator deactivation: a hospice quality improvement initiative.

    Science.gov (United States)

    Kraynik, Sally E; Casarett, David J; Corcoran, Amy M

    2014-09-01

    Dying patients whose implantable cardioverter defibrillators (ICDs) continue to deliver shocks may experience significant pain, and the National Quality Forum has endorsed routine deactivation of ICDs when patients near the end of life. The overarching goal of this quality improvement project was to increase rates of ICD deactivation among hospice patients. ICD deactivation rates pre- vs. post-intervention; and clinicians' knowledge and confidence regarding ICD management. A multifaceted intervention included clinical tools, education, and standardized documentation templates in the electronic medical record. The proportion of patients whose ICD was deactivated increased after the intervention (pre- vs. post-intervention: 39/68, 57% vs. 47/56, 84%; odds ratio 3.88; 95% confidence interval 1.54-10.37; P = 0.001). Clinicians' knowledge and confidence regarding ICD management improved (pre- vs. post-intervention median questionnaire scores: 5 vs. 9 on a scale of 0 to 10; Wilcoxon signed-rank test Z = -5.01; P < 0.001). A multifaceted intervention can increase rates of ICD deactivation among patients near the end of life. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  2. Introducing transapical aortic valve implantation (part 1): effect of a structured training program on clinical outcome in a series of 500 procedures.

    Science.gov (United States)

    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.

  3. 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.

  4. 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

  5. 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

  6. Outcome of surgical implant generation network nail initiative in ...

    African Journals Online (AJOL)

    fractures' management and outcomes. The goal of this study was to describe applicability of the SIGN initiative in fracture care in a Kenyan hospital. AbstrAct. Background: Closed interlocked intra-medullary nailing (IM), the standard method of treating of long bone shaft fracture, has been a dream to most resource poor ...

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Effects of initiating a contraceptive implant on subsequent condom use: A randomized controlled trial.

    Science.gov (United States)

    Rattray, Carole; Wiener, Jeffrey; Legardy-Williams, Jennifer; Costenbader, Elizabeth; Pazol, Karen; Medley-Singh, Natalie; Snead, Margaret C; Steiner, Markus J; Jamieson, Denise J; Warner, Lee; Gallo, Maria F; Hylton-Kong, Tina; Kourtis, Athena P

    2015-12-01

    To evaluate whether initiation of a contraceptive implant, a method of long-acting reversible contraception, reduces condom use, as measured by a biomarker of recent semen exposure [prostate-specific antigen (PSA)]. We conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the contraceptive implant at baseline ("immediate" insertion arm, N=208) or at the end ("delayed" insertion arm, N=206) of a 3-month study period. Participants were tested for PSA at baseline and two follow-up study visits and were asked about their sexual activity and condom use. At baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm [1-month: 26.1% vs. 20.2%, prevalence ratio (PR)=1.3, 95% confidence interval (CI)=0.9-1.9; 3-month: 25.6% vs. 23.1%, PR= 1.1, 95% CI=0.8-1.6]. The change in PSA positivity over the three study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value of .15). Contraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short term. This information strengthens the evidence to support promotion of implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants. Sex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant, compared with those not receiving the implant. Published by Elsevier Inc.

  19. Initiation and stability of pursuit eye movements in simulated retinal prosthesis at different implant locations.

    Science.gov (United States)

    Wang, Lin; Yang, Liancheng; Dagnelie, Gislin

    2008-09-01

    To assess the possible effects of retinal prosthesis implant location on the initiation and stability of pursuit eye movements. Six normally sighted subjects visually tracked a horizontally moving target in natural vision and in simulated prosthetic vision. Subjects were instructed to press a key when the target jumped. Prosthetic vision was simulated with a 10 x 10 array of 1 degrees diameter phosphenes. Three implant locations in the retina were simulated: macular, 8 degrees superior, and 8 degrees nasal. Target motion had two speeds: 4 degrees /s and 8 degrees /s. Eye movement latency, horizontal stability, and vertical stability were assessed. Key-press behaviors responding to target jump were analyzed to evaluate functional eye movements. Compared with natural vision, horizontal eye position with respect to target position was less stable in simulated prosthetic vision at macular, superior, and nasal implant locations, in ascending order of the degree of instability. Vertical eye position with respect to target position in simulated prosthetic vision with the superior implant location was less stable in tracking slow target motion than fast. Eye movement latency in simulated prosthetic vision was longer than in natural vision. Key-press performance was impaired in simulated prosthetic vision. Pursuit eye movements in prosthetic vision, compared to natural vision, are significantly slower in initiation and less smooth in motion. They seem, however, still functional, even if the prosthesis is implanted in the peripheral retina. A superior implant locus may help the prosthesis wearer better control horizontal eye movements, which are more frequently used in the activities of daily living.

  20. 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...

  1. Endodontic treatment options after unsuccessful initial root canal treatment: Alternatives to single-tooth implants.

    Science.gov (United States)

    Torabinejad, Mahmoud; White, Shane N

    2016-03-01

    Initial root canal treatment is highly successful, appreciated by patients, and cost-effective, but failures occur. Should a tooth with unsuccessful initial root canal treatment be treated by means of other endodontic procedures or be replaced by a single-tooth implant? Results from systematic reviews of the outcomes of nonsurgical retreatment, apical surgery, replantation, and autotransplantation show high tooth survival rates. Nonsurgical retreatment generally is prioritized before surgical endodontic treatment. Microsurgical endodontic treatment is superior to traditional surgical endodontic treatment and has high survival rates. Intentional replantation remains a viable alternative to extraction. Autotransplantation has a place, particularly in growing patients with an appropriate donor tooth. Single-tooth implants have higher survival rates, but the natural state has intrinsic value. The first-line treatment option after failure of initial root canal treatment is nonsurgical retreatment. Endodontic surgery, intentional replantation, and autotransplantation should be considered before extraction and replacement by a single-tooth implant. Comprehensive case assessment, evaluation of all endodontic options, and risk assessment for caries and periodontal disease are always necessary when choosing the optimal treatment for a patient when initial root canal treatment has failed to heal. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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...

  7. 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.

  8. 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.

  9. 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.

  10. 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.)

  11. Ten years of clinical experience in the use of fixed-pressure versus programmable valves: a retrospective study of 159 patients.

    Science.gov (United States)

    Mpakopoulou, Maria; Brotis, Alexandros G; Gatos, Haralampos; Paterakis, Konstantinos; Fountas, Kostas N

    2012-01-01

    The aim of this study was to present our 10-year experience with the use of fixed-pressure and programmable valves in the treatment of adult patients requiring cerebrospinal fluid (CSF) diversion. Patients (n = 159; 89 male and 70 female) suffering from hydrocephalus of various causes underwent CSF shunt implantation. Forty fixed-pressure and 119 programmable valves were initially implanted. The observed revision rate was 40% in patients with fixed-pressure valves. In 20% of these patients, a revision due to valve mechanism malfunction was undertaken, and the initial valve was replaced with a programmable one. The revision rate in the adjustable-pressure valve subgroup was 20%. The infection rate for the fixed-pressure and programmable valve subgroups were 3%, and 1.7%, respectively. Similarly, subdural fluid collections were noticed in 17% and 4% of patients with fixed-pressure valves and programmable valves, respectively. The revision and over-drainage rates were significantly lower when using programmable valves, and thus, this type of valve is preferred whenever CSF has to be diverted.

  12. 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.

  13. 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.

  14. 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).

  15. Initial Crestal Bone Loss After Implant Placement with Flapped or Flapless Surgery-A Prospective Cohort Study.

    Science.gov (United States)

    Maier, Frank-Michael

    2016-01-01

    Some initial loss of bone around dental implants is generally expected. There is reason to believe that reflecting a mucoperiosteal flap promotes crestal bone loss in the initial phase after an implant has been inserted. The objective of this study was to compare the effect of flapless implant insertion on initial bone loss with that of conventional placement after elevation of a mucoperiosteal flap. Eighty patients were randomly assigned either to the flapless group (test) or to the group with a full-thickness flap (control). In total, 195 implants were included in the study: 95 of these were inserted flapless (test group), and 100 were inserted by raising a mucoperiosteal flap (control group). Healing occurred unsubmerged for both groups. To assess changes in the peri-implant bone level, the height of the mesial and distal peri-implant bone was measured on digitally calibrated radiographs taken at the time of implant placement and 12 months afterward. After 1 year, a mean cumulative crestal bone loss of 0.24 ± 0.62 mm was measured. A mean bone loss of 0.55 ± 0.57 mm was found in the group with the mucoperiosteal flap, while a slight mean gain in bone height of 0.09 ± 0.49 mm was found in the test group, a statistically significant difference (P Flapless implant insertion caused less peri-implant bone loss than implant insertion with flap preparation. Therefore, the flapless procedure represents a protective and promising method in implant surgery.

  16. 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.

  17. Initial Bacterial Adhesion on Different Yttria-Stabilized Tetragonal Zirconia Implant Surfaces in Vitro

    Directory of Open Access Journals (Sweden)

    Lamprini Karygianni

    2013-12-01

    Full Text Available Bacterial adhesion to implant biomaterials constitutes a virulence factor leading to biofilm formation, infection and treatment failure. The aim of this study was to examine the initial bacterial adhesion on different implant materials in vitro. Four implant biomaterials were incubated with Enterococcus faecalis, Staphylococcus aureus and Candida albicans for 2 h: 3 mol % yttria-stabilized tetragonal zirconia polycrystal surface (B1a, B1a with zirconium oxide (ZrO2 coating (B2a, B1a with zirconia-based composite coating (B1b and B1a with zirconia-based composite and ZrO2 coatings (B2b. Bovine enamel slabs (BES served as control. The adherent microorganisms were quantified and visualized using scanning electron microscopy (SEM; DAPI and live/dead staining. The lowest bacterial count of E. faecalis was detected on BES and the highest on B1a. The fewest vital C. albicans strains (42.22% were detected on B2a surfaces, while most E. faecalis and S. aureus strains (approximately 80% were vital overall. Compared to BES; coated and uncoated zirconia substrata exhibited no anti-adhesive properties. Further improvement of the material surface characteristics is essential.

  18. 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.

  19. [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.

  20. 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.

  1. TCT-88 Innovative Transcatheter Tricuspid Valve Repair System. Initial Outcomes from the First in Human Multi-Centre Study

    National Research Council Canada - National Science Library

    Tchetche, Didier; Denti, Paolo; Juliard, Jean Michel; Latib, Azeem; Maisano, Francesco

    2016-01-01

      Procedural refinements and patient selection are currently improving, to target the proper TR population and to consider tricuspid valve repair also in combination of other percutaneous solutions (eg...

  2. Initial 2-year results of CardioCel® patch implantation in children.

    Science.gov (United States)

    Pavy, Carine; Michielon, Guido; Robertus, Jan Lukas; Lacour-Gayet, François; Ghez, Olivier

    2017-10-24

    We present the initial 2-year results of CardioCel® patch (Admedus Regen Pty Ltd, Perth, WA, Australia) implantation in paediatric patients with congenital heart diseases. This was a single-centre retrospective study with prospectively collected data of all patients aged 18 years and under operated for congenital heart disease. The patch was introduced in 2014, with clinical practice committee approval and a special consent in case of an Ozaki procedure. Standard follow-up was performed with systematic clinical exams and echocardiograms. In case of reoperation or graft failure, the patch was removed and sent for a histological examination. Between March 2014 and April 2016, 101 patients had surgical repair using a CardioCel patch. The mean age was 22 (±36.3) months, and the mean weight was 9.7 (±10.3) kg. No infections and no intraoperative implantation difficulties were associated with the patch. The median follow-up period was 212 (range 4-726) days. The overall 30-day postoperative mortality was 3.8% (n = 4), none of which were related to graft failure. Five children were reoperated because of graft failure, 4 of whom had the patch implanted for aortic and were aged less than 10 days. The indications for patch implantation in the aortic position were aortopulmonary window, truncus arteriosus, coarctation and aortic arch hypoplasia repair. The median time between the first and the second operation for graft failure was 245 (range 5-480) days. Our experience shows that the patch is well tolerated in the septal, valvar and pulmonary artery positions. However, we experienced graft failures in infants in the aortic position.

  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. 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.

  5. 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.

  6. 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

  7. Percutaneous pulmonary valve placement in a 10-month-old patient using a hand crafted stent-mounted porcine valve.

    Science.gov (United States)

    Feinstein, Jeffrey A; Kim, Nancy; Reddy, V Mohan; Perry, Stanton B

    2006-04-01

    Percutaneous replacement of the pulmonary valve in a right ventricle to pulmonary artery (RV-PA) conduit using bovine jugular valves has recently been described as an alternative to surgical options in selected patients weighing >or=20 kg. We report the first case of transcatheter pulmonary valve implantation in an infant and the first use of "off the shelf" components. A 12-mm (Hancock) porcine valve was sutured into a predilated Genesis 2510b stent. The valved stent was manually crimped and mounted on a 12-mm balloon. Snare-assisted deployment in the middle of the RV-PA conduit was accomplished without the use of a long sheath. After the initial deployment, a 14-mm balloon was used to further approximate the stent to the walls of the conduit. Short-term (11 month) follow-up has demonstrated continued valve integrity, markedly decreased right ventricular size and improved function and symptomatic improvement. At 10 months of age, this case represents the youngest patient to undergo percutaneous valve placement and documents the technical feasibility of the procedure.

  8. 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.

  9. 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

  10. 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.

  11. 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.)

  12. 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 ...

  13. Modeling the Mitral Valve

    Science.gov (United States)

    Kaiser, Alexander

    2016-11-01

    The mitral valve is one of four valves in the human heart. The valve opens to allow oxygenated blood from the lungs to fill the left ventricle, and closes when the ventricle contracts to prevent backflow. The valve is composed of two fibrous leaflets which hang from a ring. These leaflets are supported like a parachute by a system of strings called chordae tendineae. In this talk, I will describe a new computational model of the mitral valve. To generate geometry, general information comes from classical anatomy texts and the author's dissection of porcine hearts. An MRI image of a human heart is used to locate the tips of the papillary muscles, which anchor the chordae tendineae, in relation to the mitral ring. The initial configurations of the valve leaflets and chordae tendineae are found by solving solving an equilibrium elasticity problem. The valve is then simulated in fluid (blood) using the immersed boundary method over multiple heart cycles in a model valve tester. We aim to identify features and mechanisms that influence or control valve function. Support from National Science Foundation, Graduate Research Fellowship Program, Grant DGE 1342536.

  14. 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.

  15. Bone ingrowth and initial stability of titanium and porous tantalum dental implants: a pilot canine study.

    Science.gov (United States)

    Kim, Do-Gyoon; Huja, Sarandeep S; Tee, Boon Ching; Larsen, Peter E; Kennedy, Kelly S; Chien, Hua-Hong; Lee, Jin Whan; Wen, Hai Bo

    2013-08-01

    To investigate if a dental implant system with a midsection covered by 3-dimensionally porous tantalum material would exhibit stability comparable with a traditional threaded titanium alloy implant system and whether bone would grow into the porous section. Three experimental and 3 control implants were placed in the individual mandibles of 8 dogs. Resonance frequency analysis assessed implant stability at 0, 2, 4, 8, and 12 weeks of healing. Histomorphometric and backscattered scanning electron microscopic analyses examined the presence of bone ingrowth into the experimental implant's porous section and bone-to-implant contact along the titanium surfaces of both implants. Implant stability did not significantly differ during 0 to 12 weeks of healing. Progressive tissue mineralization developed inside porous sections from weeks 2 to 12. Porous implants exhibited a combination of progressive osseointegration along their titanium surfaces and bone ingrowth inside their porous tantalum sections. Cortical and apical implant threads, combined with the porous section, were able to stabilize the experimental implant to the same degree as the fully threaded control implant.

  16. 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...

  17. Textile heart valve prosthesis: from fabric design criteria to early in-vivo performances.

    Science.gov (United States)

    Heim, Frederic; Durand, Bernard; Chafke, Nabil

    2013-05-01

    Percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patients at high risk for open-chest surgery. Biological valve tissue is, however, a fragile material when folded for small-diameter catheter insertion purposes. Textile polyester is a less fragile material, and could be an alternative replacement for the valve leaflets. The dynamic performances obtained in vitro with a valve prosthesis made from textile have proven in previous studies to be satisfactory. However, as textile is a porous material the interaction processes between the fabric leaflet surfaces and living tissues remain unknown. The study aim was to discuss the fabric design criteria which are best suited to clinical application. An appropriate design provided strength, limited porosity and low bulk to the fabric, which was particularly suited for small-diameter catheter insertion purposes. The in-vivo behavior of a non-coated polyester textile valve prototype was then studied in the mitral position in a sheep model. The results showed that limited tissue ingrowth occurred, and Ca deposits tended to stiffen the fabric leaflets after a two-month implantation period, which was not compatible with the survival of the animal. The initial results obtained with this non-coated polyester textile valve confirmed that this revolutionary fabric is worthy of further investigation.

  18. Timing of vitamin K antagonist re-initiation following intracranial hemorrhage in mechanical heart valves: Systematic review and meta-analysis.

    Science.gov (United States)

    AlKherayf, Fahad; Xu, Yan; Gandara, Esteban; Westwick, Harrison; Moldovan, Ioana Doina; Wells, Philip S

    2016-08-01

    While evidence supports resumption of vitamin K antagonists (VKAs) among mechanical heart valve (MHV) patients presenting with anticoagulant-associated intracranial hemorrhage (ICH), ideal timing of resumption is uncertain. To determine the optimal timing of VKA re-initiation and its associated clinical outcomes. We performed a systematic review and a meta-analysis of studies published from January 1950 to August 2015. We extracted data on the location of initial ICH, use of cranial surgery, presence of atrial fibrillation, MHV type and position, number of MHVs, and timing of VKA resumption. Outcomes including valve thrombosis, thromboembolic events or ICH recurrence were recorded. Meta-regression analysis was conducting with controlling for covariates. We calculated absolute risks, and assessed the effect of anticoagulant resumption timing on ICH recurrence. 23 case-series and case-reports were identified. Overall ICH recurrence was 13% (95% confidence interval [CI], 7%-25%), while valve thrombosis and ischemic strokes occurred at 7% (95% CI, 3%-17%) and 12% (95% CI, 5%-23%) respectively. A trend towards lower ICH recurrence was observed with delayed VKA resumption (slope estimate -0.2154, p=0.10). Recurrence rate ranged from 50% with VKA resumption at 3days to 0% with resumption at 16days. Among patients with MHV, there is inadequate data to suggest an optimal timing of VKA re-initiation following an ICH, though delayed restart appears to be protective against recurrence but is associated with higher risk of thrombosis. Our analysis suggests 4-7days might be an ideal time with least risk of thrombosis or ICH recurrence. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Mechanical and Histological Effects of Resorbable Blasting Media Surface Treatment on the Initial Stability of Orthodontic Mini-Implants

    Directory of Open Access Journals (Sweden)

    Odontuya Gansukh

    2016-01-01

    Full Text Available Introduction. This study aimed to evaluate the effects of resorbable blasting media (RBM treatment on early stability of orthodontic mini-implants by mechanical, histomorphometric, and histological analyses. Methods. Ninety-six (64 for mechanical study and 32 for histological study and histomorphometric analysis titanium orthodontic mini-implants (OMIs with machined (machined group or RBM-treated (CaP surface (RBM group were implanted in the tibiae of 24 rabbits. Maximum initial torque (MIT was measured during insertion, and maximum removal torque (MRT and removal angular momentum (RAM were measured at 2 and 4 weeks after implantation. Bone-to-implant contact (BIC and bone area (BA were analyzed at 4 weeks after implantation. Results. RBM group exhibited significantly lower MIT and significantly higher MRT and RAM at 2 weeks than machined group. No significant difference in MRT, RAM, and BIC between the two groups was noted at 4 weeks, although BA was significantly higher in RBM group than in machined group. RBM group showed little bone resorption, whereas machined group showed new bone formation after bone resorption. Conclusions. RBM surface treatment can provide early stability of OMIs around 2 weeks after insertion, whereas stability of machined surface OMIs may decrease in early stages because of bone resorption, although it can subsequently recover by new bone apposition.

  20. 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.

  1. The future of heart valve banking and of homografts: perspective from the Deutsches Herzzentrum Berlin.

    Science.gov (United States)

    Delmo Walter, E M; de By, T M M H; Meyer, R; Hetzer, R

    2012-01-01

    Ever since the early days of homograft implantation in 1956, and the introduction into clinical practice by Ross and Barrat Boyes, homograft heart valves have proven to have many advantages. Its disadvantages became evident during long-term follow up. Factors, such as donor and recipient morbidity, tissue banking techniques, and the often complex surgical technique required to implant, are of great influence on the long term results. Because of European Directives, legally binding quality assurance regulations have been introduced in homograft banks. However, still not all processing methods have been scientifically sub-structured on their effects on the final product and its durability. The donor shortage has stimulated researchers and industries to develop and improve mechanical and biological valve substitutes such as the stentless bioprostheses. In general, candidates for homograft valve implantation include patients with: endocarditis, congenital defects and women who wish to become pregnant. For each category of patients different implantation techniques are required. The results of homograft banking and homograft transplantation in the German Heart Institute Berlin are satisfactory. Freedom of re-infection rate after homograft implantation is 91.9% +/- 3.6% after 15 years. Current developments show an increased interest in tissue engineered as well as in de- and re-cellularization of heart valve homografts. The advantages and disadvantages of the several processing techniques have not yet been proven in long term clinical results. For homograft bankers these developments pose as a challenge to join forces and to initiate cooperate projects aimed at scientific and organizational development.

  2. 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.

  3. 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.

  4. 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.

  5. The Risk of Acute Kidney Injury and Its Impact on 30-Day and Long-Term Mortality after Transcatheter Aortic Valve Implantation

    Directory of Open Access Journals (Sweden)

    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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. Differences between inflammatory and catabolic mediators of peri-implantitis and periodontitis lesions following initial mechanical therapy: An exploratory study.

    Science.gov (United States)

    Ghighi, M; Llorens, A; Baroukh, B; Chaussain, C; Bouchard, P; Gosset, M

    2017-09-12

    The aim of this study was to analyze the differences in inflammatory and catabolic mediators expressed in peri-implantitis compared to periodontitis lesions after non-surgical therapy. Peri-implantitis is associated with a faster rate of bone loss when compared with periodontitis, and peri-implant non-surgical therapy is ineffective to cure peri-implantitis. This may be due to persistent inflammation in peri-implantitis tissues after initial mechanical treatment. Eleven patients with peri-implantitis and 10 with severe chronic periodontitis received non-surgical therapy. They were included at re-evaluation (8 weeks) if they presented pocket depth ≥6 mm with bleeding on probing, and the indication for open flap debridement surgery. Connective tissues were harvested during surgery from diseased sites. Healthy gingiva were harvested during third molar extraction in a third group of healthy patients (n=10). Explants were incubated for 24 hours in media culture and the release of cytokines, chemokines, growth factors, osteoprotegerin, receptor activator of nuclear factor kappa-B ligand (RANKL), matrix metalloproteinase and tissue inhibitors of matrix metalloproteinase (TIMP) in the conditioned media was analyzed by an exploratory multiplex immunoassay. When difference was found in the conditioned media, an immunohistochemistry was performed to compare expression in the tissues. Connective tissues from non-stabilized peri-implantitis exhibited a distinct cytokine profile compared to periodontitis lesions that did not respond to initial therapy. Indeed, TIMP-2 was significantly increased in media from peri-implantitis (P≤.05). In addition, the in situ expression of TIMP-2, interleukin-10 and RANKL was also significantly increased in peri-implantitis tissues (P≤.05). However, the ratio of RANKL/osteoprotegerin-positive cells did not vary (P≥.05). This study suggests that peri-implantitis and periodontitis connective tissues exhibit differences in response to non

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.

    Science.gov (United States)

    Tarantini, Giuseppe; Mojoli, Marco; Purita, Paola; Napodano, Massimo; D'Onofrio, Augusto; Frigo, Annachiara; Covolo, Elisa; Facchin, Michela; Isabella, Giambattista; Gerosa, Gino; Iliceto, Sabino

    2015-07-01

    Early data on the Edwards SAPIEN 3 valve (S3-THV) have shown low rates of paravalvular leaks and vascular complications but relatively high 30-day permanent pacemaker implantation (PPMI) rates. No direct comparisons on clinical outcomes including PPMI rates are available for the S3-THV and the Edwards SAPIEN XT (XT-THV). We aimed to compare the 30-day PPMI rates in patients treated with the two prostheses and to assess the interplay among valve type, depth of implantation and PPMI rate. Two hundred and nine patients treated by TAVI were considered. The S3-THV was associated with higher PPMI rates compared to the XT-THV, both overall and in subgroups matched for several predictors of PPMI. However, in the S3-THV group, 30-day PPMI was strictly associated with deep valve implantation, and PPMI risk of high-implanted S3-THVs was similar to that of the overall XT-THV matched group. No cases of significant paravalvular leak were observed in the S3-THV group. The S3-THV was associated with a higher incidence of PPMI compared to the XT-THV. In the S3-THV group, pacemaker implantation was strictly associated with deep valve implantation. An implantation technique involving higher initial placement of the central marker (from 0 to 3 mm above the base of the aortic cusps) and, as a consequence, higher final valve depth might help in preventing post-TAVI PPMI with the S3-THV, without affecting the risk of paravalvular leak.

  16. Paediatric Melody® mitral valve replacement in acute endocarditis - alternative surgical-hybrid technique.

    Science.gov (United States)

    Haponiuk, Ireneusz; Chojnicki, Maciej; Jaworski, Radosław; Steffens, Mariusz; Paczkowski, Konrad; Szofer-Sendrowska, Aneta; Paśko-Majewska, Marta; Gierat-Haponiuk, Katarzyna; Romanowicz, Anna; Szymanowicz, Wiktor

    2017-01-01

    Acute endocarditis (AE) is still rare disease in the paediatric population; nevertheless, the children suffering from AE usually need heart valve repair or replacement in emergency settings. We present a case of emergency mitral valve replacement with the use of Melody balloon expandable stented bioprosthesis in a two-year-old patient with AE and subsequent mitral (bicuspid) valve incompetence after aggressive infective destruction with the symptoms of critical multi-organ failure. The patient, with a history of rapid deterioration after two-week-long septicaemia in the course of AE, was operated urgently after initial antibiotic treatment because of huge vegetations into the mitral valve orifice. A Melody TVP 22 valve was expanded over a 16-mm TyShak balloon and implanted into a mitral position (Melody-MVR) with good result. Based on current knowledge concerning heart valve reconstructions and institutional experience, we conclude that infected mitral valve in children should be primarily repaired; nevertheless, the Melody valve could be reasonably con-sidered as a mitral prosthesis in such conditions.

  17. Initial non-opioid based anesthesia in a parturient having severe aortic stenosis undergoing cesarean section with aortic valve replacement

    Directory of Open Access Journals (Sweden)

    Subrata Podder

    2015-01-01

    Full Text Available Pregnancy in presence of severe aortic stenosis (AS causes worsening of symptoms needing further intervention. In the advanced stages of pregnancy, some patients may even require aortic valve replacement (AVR and cesarean delivery in the same sitting. Opioid based general anesthesia for combined lower segment cesarean section (LSCS with AVR has been described. However, the use of opioid may lead to fetal morbidity and need of respiratory support for the baby. We describe successful anesthetic management for LSCS with AVR in a >33 week gravida with severe AS and congestive heart failure. We avoided opioids till delivery of the baby AVR; the delivered neonate showed a normal APGAR score.

  18. 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.

  19. 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.

  20. Vowel Confusion Patterns in Adults during Initial 4 Years of Implant Use

    Science.gov (United States)

    Vaalimaa, Taina T.; Sorri, Martti J.; Laitakari, Jaakko; Sivonen, Ville; Muhli, Arto

    2011-01-01

    This study investigated adult cochlear implant users' (n == 39) vowel recognition and confusions by an open-set syllable test during 4 years of implant use, in a prospective repeated-measures design. Subjects' responses were coded for phoneme errors and estimated by the generalized mixed model. Improvement in overall vowel recognition was highest…

  1. 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 ...

  2. High- Versus Low-Gradient Severe Aortic Stenosis: Demographics, Clinical Outcomes, and Effects of the Initial Aortic Valve Replacement Strategy on Long-Term Prognosis.

    Science.gov (United States)

    Taniguchi, Tomohiko; Morimoto, Takeshi; Shiomi, Hiroki; Ando, Kenji; Kanamori, Norio; Murata, Koichiro; Kitai, Takeshi; Kawase, Yuichi; Izumi, Chisato; Miyake, Makoto; Mitsuoka, Hirokazu; Kato, Masashi; Hirano, Yutaka; Matsuda, Shintaro; Inada, Tsukasa; Nagao, Kazuya; Murakami, Tomoyuki; Takeuchi, Yasuyo; Yamane, Keiichiro; Toyofuku, Mamoru; Ishii, Mitsuru; Minamino-Muta, Eri; Kato, Takao; Inoko, Moriaki; Ikeda, Tomoyuki; Komasa, Akihiro; Ishii, Katsuhisa; Hotta, Kozo; Higashitani, Nobuya; Kato, Yoshihiro; Inuzuka, Yasutaka; Maeda, Chiyo; Jinnai, Toshikazu; Morikami, Yuko; Saito, Naritatsu; Minatoya, Kenji; Kimura, Takeshi

    2017-05-01

    There is considerable debate on the management of patients with low-gradient severe aortic stenosis (LG-AS), defined as aortic valve area strategy: n=977, and conservative strategy: n=1120) with high-gradient severe aortic stenosis (HG-AS) and 1712 patients (initial AVR strategy: n=219, and conservative strategy: n=1493) with LG-AS. AVR was more frequently performed in HG-AS patients than in LG-AS patients (60% versus 28%) during the entire follow-up. In the comparison between the initial AVR and conservative groups, the propensity score-matched cohorts were developed in both HG-AS (n=887 for each group) and LG-AS (n=218 for each group) strata. The initial AVR strategy when compared with the conservative strategy was associated with markedly lower risk for a composite of aortic valve-related death or heart failure hospitalization in both HG-AS and LG-AS strata (hazard ratio, 0.30; 95% confidence interval, 0.25-0.37; Pstrategy was associated with a better outcome than the conservative strategy (adjusted hazard ratio, 0.37; 95% confidence interval, 0.23-0.59; Pstrategy was associated with better outcomes than the conservative strategy in both HG-AS and LG-AS patients, although AVR was less frequently performed in LG-AS patients than in HG-AS patients. The favorable effect of initial AVR strategy was also seen in patients with LG-AS with preserved left ventricular ejection fraction. URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000012140. © 2017 American Heart Association, Inc.

  3. 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.

  4. Initial experience with implantation of novel dual layer flow-diverter device FRED.

    Science.gov (United States)

    Poncyljusz, Wojciech; Sagan, Leszek; Safranow, Krzysztof; Rać, Monika

    2013-09-01

    Flow-diverting stents can help treat complex and wide-necked cerebral aneurysms. The aim of the study was to evaluate initial experiences related to the safety and effectiveness of eight aneurysms treated with a new dual layer coverage designed flow-diverter device. In 2012 Fred flow-diverter devices were used to treat 8 unruptured wide neck (dome-neck ratio ≤ 1.5) and sidewall aneurysms in 6 patients. All aneurysms were located in the anterior circulation on the internal carotid artery (ICA). In 4 larger aneurysms (> 10 mm) one 3D coil in association with Fred was used to reduce potential incidence of postoperative subarachnoid haemorrhage (SAH). Dual antiplatelet therapy was administered before the procedure and continued for 3 months after it. Clinical parameters, aneurysm features and 3-month follow-up angiograms are presented. All 6 patients with 8 aneurysms were successfully stented with the Fred flow-diverter device and were discharged in generally good condition on dual-antiplatelet therapy. No complications were related to the procedure. In 5 cases digital subtraction angiography (DSA) control examination was performed after 3 months, showing complete occlusion of the aneurysms with patency of the parent artery. In 1 case thrombosis of the Fred occurred but without any clinical consequences because of cross-flow from the other side. Use of the Fred flow-diverter device was efficacious in all 8 treated cerebral aneurysms. The system seems to be promising as a flow diverter with certain characteristics, which allow for easy delivery and implantation. Further clinical evaluation with a larger group of patients is needed.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. [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.

  10. Determinants of dentists' decisions to initiate dental implant treatment: a judgment analysis.

    Science.gov (United States)

    Koele, P; Hoogstraten, J

    1999-04-01

    Do psychosocial patient characteristics influence the decision of a dentist in recommending implant treatment? This study assessed the importance that dental general practitioners attach to psychosocial patient characteristics when judging the suitability of these patients for dental implant treatment. The judgment strategy of 30 Dutch dental practitioners was studied by using 2 tasks. Dentists first judged a series of written scenarios representing fictitious patients, each patient being characterized by 4 psychosocial aspects to determine the patients' suitability for implant treatment. The second task involved rank ordering 14 patient characteristics according to their importance in implant treatment decisions. Dentists judged the personal appearance of the patient and, to a lesser degree, the patient's socioeconomic status to influence decisions to treat. However, these characteristics are ranked as quite unimportant in decision making, whereas motivation, oral hygiene, and level of neuroticism were the most important patient characteristics. The results on the 2 tasks were clearly not in agreement. There was a substantial disagreement between what dentists say to be important characteristics (rank order task) and the characteristics they actually use to judge the suitability for implant treatment (scenario task). Moreover, it appeared that agreement among the dentists is quite low, especially for the scenario task.

  11. Development of off-pump mitral valve replacement in a porcine model.

    Science.gov (United States)

    Gillespie, Matthew J; Aoki, Chikashi; Takebayashi, Satoshi; Shimaoka, Toru; McGarvey, Jeremy R; Gorman, Robert C; Gorman, Joseph H

    2015-04-01

    We describe our initial experience with on-bypass and off-bypass (off-pump) mitral valve replacement with the modified version of our novel catheter-based sutureless mitral valve (SMV) technology, which was developed to atraumatically anchor and seal in the mitral position. The SMV is a self-expanding device consisting of a custom designed nitinol framework and a pericardial leaflet valve mechanism. For the current studies, our original device was modified (SMV2) to reduce the delivery profile and to allow for controlled deployment while still maintaining the key principles necessary for atraumatic anchoring and sealing in the mitral valve position. Ten Yorkshire pigs underwent successful SMV2 device implantation through a left atriotomy (on-pump, n = 6; off-pump, n = 4). Echocardiography and angiography revealed excellent left ventricular systolic function, no significant perivalvular leak, no mitral valve stenosis, no left ventricular outflow tract obstruction, and no aortic valve insufficiency. Postmortem examination demonstrated that the SMV2 devices were anchored securely. This study demonstrates the feasibility and short-term success of off-pump mitral valve replacement using a novel, catheter-based device in a porcine model. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  12. 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

  13. 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.

  14. Transplante de valva mitral heteróloga: Nova alternativa cirúrgica: estudo clínico inicial Heterologous mitral valve transplant: New surgical technique: initial clinical trial

    Directory of Open Access Journals (Sweden)

    Mário O Vrandecic

    1993-06-01

    mitral valve substitute. This stentless heterologous mitral valve was implanted in 38 patients, without hospital mortality. Their mean age was 29 years. Female gender predominated (69%. The most common mitral dysfunction was the double mitral valve lesion (53%. Eighteen (47% patients were in functional class III and 20 (53% in class IV of the NYHA. There was one valve related complication (our first patient, due to disproportion of patients, large annulus and the incorrectly size chosen. This complication led us to the strict adherence of our protocol, which is based upon animal experimentation. The satisfactory operatory and clinical results, throughout this 12 months of follow-up, confirm that the stentless heterologous mitral valve is the natural mitral substitute, when considering mitral valve replacement. This first natural mitral valve substitute, tanned with a non-aldehyde tissue treatment, proved to avoid calcification and to produce no foreign reaction, hence it may be the best choice in order to obtain better quality of life and the desired valve durability. Using both, the natural design mitral valve and the non-aldehyde treatment, the last 6 patients of this series received this devicxe and is certainly hoped that, due to the more natural model and the non-calcificant and inhert tissue, patients own cells will be responsible to greatly delay tissue degeneration, providing longterm durability.

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. Tricuspid Valve Replacement, Mechnical vs. Biological Valve, Which Is Better?

    Directory of Open Access Journals (Sweden)

    Haitham Akram Altaani

    2013-06-01

    Full Text Available Background: The initial trial in tricuspid surgery is repair; however, replacement is done whenever the valve is badly diseased. Tricuspid valve replacement comprises 1.7% of all tricuspid valve surgeries. Materials and Methods: The present retrospective study was performed using the medical records of 21 cases who underwent tricuspid valve replacement from January 2002 until the end of December 2010. The mean age of the participants was 52.3±8.8 years and 66.7% were females. In addition, tricuspid valve replacement was associated with mitral valve surgery, aortic valve surgery, and both in 14.3%, 4.8%, and 33.3% of the cases, respectively. Yet, isolated tricuspid valve replacement and redo surgery were performed in 10 cases (47.6% and 8 cases (38.1%, respectively. Besides, trial of repair was done in 14 cases (66.7%. Moreover, biological and mechanical valves were used in 76.2% and 23.8% of the patients, respectively. Results: According to the results, early mortality was 23.8% and one year survival was 66.7%. Moreover, early mortality was caused by right ventricular failure, multiorgan failure, medistinitis, and intracerbral bleeding in 42%, 28.6%, 14.3%, and 14.3% of the cases, respectively. In addition, 57.1% of the deaths had occurred in the cases where the biological valve was used, while 42.9% of the deaths had taken place where the mechanical one was utilized. Conclusions: The patients who require tricuspid valve replacement are usually high risk surgical candidates with early and long term mortality. The findings of the current study showed no significant hemodynamic difference between mechanical and biological valves.

  2. Percutaneous implantation of a ventricular partitioning device for treatment of ischemic heart failure: initial experience of a center.

    Science.gov (United States)

    Silva, Guida; Melica, Bruno; Pires de Morais, Gustavo; Sousa, Olga; Bettencourt, Nuno; Ribeiro, José; Simões, Lino; Gama, Vasco

    2012-12-01

    The Parachute is a novel left ventricular (LV) partitioning device that is deployed percutaneously in the left ventricle in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction (MI). The implantable device is a partitioning membrane that isolates the dysfunctional region of the ventricle and decreases chamber volume. Data from the first-in-human clinical trial - the Percutaneous Ventricular Restoration in Chronic Heart Failure (PARACHUTE) trial- has shown that this new device is associated with significant and sustained LV volume reduction and improvement in LV hemodynamics and functional capacity in the 12 months after implantation, with a relatively low rate of clinical events, indicating that it may have a beneficial effect in the treatment of ischemic heart failure. We aim to describe our initial experience with implantation of the Parachute LV partitioning device and its short-term safety, defined as the successful delivery and deployment of the device. Copyright © 2012 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

  3. A rare case report of peri-implant bone necrosis: Mapping the distance of initial peri-implant complication toward a path of success

    Directory of Open Access Journals (Sweden)

    S K Salaria

    2011-01-01

    Full Text Available In the past decade, science of implant placement has greatly advanced and at the same time much success has been experienced with the endosseous implant. Despite the long-term predictability of the implants, however, biological, technical and esthetic complications do occur. The use of osseointegrated implants as a foundation for prosthetic replacement of missing teeth has been highly predictable, but still at present, there is no consensus of how to best manage the complications occurring after implant placement. In this report, we discuss post-insertion complication of bone necrosis and its successful management.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. Structural valve deterioration in the Mitroflow biological heart valve prosthesis

    DEFF Research Database (Denmark)

    Issa, Issa Farah; Poulsen, Steen Hvitfeldt; Waziri, Farhad

    2018-01-01

    OBJECTIVES: Concern has been raised regarding the long-term durability of the Mitroflow biological heart valve prosthesis. Our aim was to assess the incidence of structural valve degeneration (SVD) for the Mitroflow bioprosthesis in a nationwide study in Denmark including all patients alive...... in Denmark who had received a Mitroflow aortic bioprosthesis since 2000. METHODS: Patients alive in Denmark with a Mitroflow bioprosthesis implanted since January 2000 were invited to participate in a nationwide cross-sectional study with a predefined definition of SVD. Of 1552 patients, 861 patients had...

  9. Progression of Aortic Regurgitation After Different Repair Techniques for Congenital Aortic Valve Stenosis.

    Science.gov (United States)

    Kari, Fabian A; Kroll, Johannes; Kiss, Jan; Hess, Carolin; Stiller, Brigitte; Siepe, Matthias; Beyersdorf, Friedhelm

    2016-01-01

    We sought to characterize the incidence of AR progression and determine risk factors for AR progression in a consecutive series of infants and children after surgical correction of congenital aortic valvular and supravalvular stenosis. N = 30 patients underwent repair of the aortic valve for isolated congenital aortic valve stenosis (n = 14, 47 %) or combined with aortic regurgitation (AR, n = 16, 53%). N = 27 (90%) had a valvular and n = 3 patients (10%) presented with supravalvular pathology of their aortic valve. In n = 16 patients (53%) a bicuspid and in n = 2 (6%) patients, a unicuspid valve was present. Comparative survival was analyzed using the Cox model and log-rank calculations. Log-rank calculations were performed for variables reaching statistical significance in order to identify differences in survival between groups. Commissurotomy was performed in n = 20 patients, patch implantation in n = 4, cusp shaving in n = 8, cusp prolapse correction in n = 3, and cusp augmentation in n = 4 patients. In patients with combined dysfunction and preoperative AR, AR was successfully reduced by the initial procedure, and postoperatively the overall median AR grade was 1+ (range 0-2.5+, p = 0.001, for AR reduction among patients with any grade of preoperative AR). By the time of follow-up echocardiography, the median AR grade had significantly progressed toward 1.5+ (p = 0.004). At the time of mid-term follow-up at 3.2 years, none of the patients had moderate or severe AR grades >2.5+. Patients with a monocuspid aortic valve and patients who had some kind of patch implantation into their cusps or commissures or shaving of thickened cusps were more likely to present with progression of aortic regurgitation. Monocuspid aortic valve and patch implantation, as well as cusp shaving, are probably linked to AR progression. The standard procedure of commissurotomy results in an absolute rate of AR progression of 40 % over a medium-term follow-up period.

  10. Non-Newtonian Blood Flow Simulation of Diastolic Phase in Bileaflet Mechanical Heart Valve Implanted in a Realistic Aortic Root Containing Coronary Arteries.

    Science.gov (United States)

    Hanafizadeh, Pedram; Mirkhani, Nima; Davoudi, Mohammad Reza; Masouminia, Mahtab; Sadeghy, Keyvan

    2016-10-01

    Coronary arteries, which are branched from the sinuses, have tangible effects on the hemodynamic performance of the bileaflet mechanical heart valve (BMHV), especially in the diastolic phase. To better understand this issue, a computer model of ascending aorta including realistic sinus shapes and coronary arteries has been generated in this study in order to investigate the BMHV performance during diastole. Three-dimensional transient numerical analysis is conducted to simulate the diastolic blood flow through the hinges and in coronary arteries under the assumption of non-Newtonian behavior. Results indicate that as blood flows to the coronary arteries mainly during diastole, leakage flow from the hinge and other gaps will change considering the influence of coronary arteries. In addition, BMHV in the case of aortic replacement will increase blood flow rate into the coronary arteries about 100% as the mechanical valve resistance is higher than a native heart valve. Also, it will change the wall shear stress (WSS) distribution and increase coronary artery disease (CAD) potential. It is found out that although less leakage flow reduces the velocity magnitudes through the gaps, the shear stress acting on blood elements with non-Newtonian assumption will be detrimental in the hinge corner at the ventricular side. High WSS of 1800 Pa is observed at beginning of diastole at this region. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  11. TRINITY heart valve prosthesis: a novel repositionable and retrievable transapical transcatheter aortic valve system.

    Science.gov (United States)

    Hengstenberg, Christian; Condado, Jose; Garcia, David; Martinez, Milka Marin; La Forgia, Giambattista; Ebner, Adrian; Gallo, Santiago; Silva, Enrique; Holzamer, Andreas; Husser, Oliver; Hilker, Michael

    2015-03-01

    Transcatheter aortic valve implantation (TAVI) has become a viable option for selected high-risk patients with severe and symptomatic aortic stenosis. First- and second-generation TAVI devices are either self- or balloon-expandable, and are often not repositionable or not fully retrievable, leading to suboptimal positioning in some cases. This may result in paravalvular regurgitation, AV conduction delay, or compromise of coronary perfusion. A broader application of TAVI requires advances in both valve and delivery systems. Therefore, in order to facilitate accurate positioning, to minimise paravalvular leakage, possibly to reduce the risk of AV conduction delay, and possibly to be able to abort the procedure, a "next-generation" TAVI system has been developed which is repositionable and retrievable, the TRINITY heart valve system. The TRINITY heart valve system was implanted in a first-in-human study using the transapical approach to demonstrate feasibility and procedural success. All endpoints were adjudicated according to VARC definitions at seven and 30 days. The TRINITY heart valve system was implanted in a 74-year-old patient with severe symptomatic aortic valve stenosis. In this case, repositioning of the TRINITY resulted in optimal position without paravalvular leakage and with perfect function. The TRINITY heart valve is a repositionable and retrievable TAVI system. Both the implantation result and short-term clinical and haemodynamic outcome were excellent.

  12. Experimental model of biofilm implant-related osteomyelitis to test combination biomaterials using biofilms as initial inocula.

    Science.gov (United States)

    Williams, Dustin L; Haymond, Bryan S; Woodbury, Kassie L; Beck, J Peter; Moore, David E; Epperson, R Tyler; Bloebaum, Roy D

    2012-07-01

    Currently, the majority of animal models that are used to study biofilm-related infections use planktonic bacterial cells as initial inocula to produce positive signals of infection in biomaterials studies. However, the use of planktonic cells has potentially led to inconsistent results in infection outcomes. In this study, well-established biofilms of methicillin-resistant Staphylococcus aureus were grown and used as initial inocula in an animal model of a Type IIIB open fracture. The goal of the work was to establish, for the first time, a repeatable model of biofilm implant-related osteomyelitis, wherein biofilms were used as initial inocula to test combination biomaterials. Results showed that 100% of animals that were treated with biofilms developed osteomyelitis, whereas 0% of animals not treated with biofilm developed infection. The development of this experimental model may lead to an important shift in biofilm and biomaterials research by showing that when biofilms are used as initial inocula, they may provide additional insights into how biofilm-related infections in the clinic develop and how they can be treated with combination biomaterials to eradicate and/or prevent biofilm formation. Copyright © 2012 Wiley Periodicals, Inc.

  13. The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis.

    Science.gov (United States)

    Beckmann, A; Hamm, C; Figulla, H R; Cremer, J; Kuck, K H; Lange, R; Zahn, R; Sack, S; Schuler, G C; Walther, T; Beyersdorf, F; Böhm, M; Heusch, G; Funkat, A K; Meinertz, T; Neumann, T; Papoutsis, K; Schneider, S; Welz, A; Mohr, F W

    2012-07-01

    Background The increasing prevalence of severe aortic valve defects correlates with the increase of life expectancy. For decades, surgical aortic valve replacement (AVR), under the use of extracorporeal circulation, has been the gold standard for treatment of severe aortic valve diseases. In Germany ~12,000 patients receive isolated aortic valve surgery per year. For some time, percutaneous balloon valvuloplasty has been used as a palliative therapeutic option for very few patients. Currently, alternatives for the established surgical procedures such as transcatheter aortic valve implantation (TAVI) have become available, but there are only limited data from randomized studies or low-volume registries concerning long-time outcome. In Germany, the implementation of this new technology into hospital care increased rapidly in the past few years. Therefore, the German Aortic Valve Registry (GARY) was founded in July 2010 including all available therapeutic options and providing data from a large quantity of patients.Methods The GARY is assembled as a complete survey for all invasive therapies in patients with relevant aortic valve diseases. It evaluates the new therapeutic options and compares them to surgical AVR. The model for data acquisition is based on three data sources: source I, the mandatory German database for external performance measurement; source II, a specific registry dataset; and source III, a follow-up data sheet (generated by phone interview). Various procedures will be compared concerning observed complications, mortality, and quality of life up to 5 years after the initial procedure. Furthermore, the registry will enable a compilation of evidence-based indication criteria and, in addition, also a comparison of all approved operative procedures, such as Ross or David procedures, and the use of different mechanical or biological aortic valve prostheses.Results Since the launch of data acquisition in July 2010, almost all institutions performing

  14. Different impact of aortic regurgitation assessed by aortic root angiography after transcatheter aortic valve implantation according to baseline left ventricular ejection fraction and N-terminal pro-B-type natriuretic peptide.

    Science.gov (United States)

    Kaneko, Hidehiro; Hoelschermann, Frank; Schau, Thomas; Tambor, Grit; Neuss, Michael; Butter, Christian

    2017-05-31

    Transcatheter aortic valve implantation (TAVI) is an alternative therapeutic option for severe aortic stenosis. Aortic regurgitation (AR) is commonly observed after TAVI and increases the mortality rate. We hypothesized that the influence of significant AR, defined as that more severe than mild AR, on survival rate after TAVI might differ according to the baseline left ventricular ejection fraction (LVEF) and N-terminal pro-B-type natriuretic peptide (NT-pro BNP) level. We categorized 856 patients who underwent transfemoral TAVI into 2 groups according to their baseline LVEF (5000 pg/mL). Significant AR was observed in 92 patients (11%). Among patients with significant AR, the proportion of patients with CoreValve/EvolutR implantation was higher than that of patients with SAPIEN XT/3 implantation. Kaplan-Meier curves and the log-rank test showed that significant AR was not associated with 1-year mortality in patients with LVEF ≥40% and those with NT-pro BNP level ≤5000 pg/mL. On the other hand, it was significantly associated with a higher 1-year mortality in patients with LVEF 5000 pg/mL (p = 0.011). Similarly, multivariate Cox regression analysis showed that the presence of AR was significantly associated with a higher 1-year mortality in patients with LVEF 5000 pg/mL (p = 0.004, HR = 3.221). However, AR was not significantly associated with a higher 1-year mortality in patients with LVEF ≥40% and NT-pro BNP level ≤5000 pg/mL. Thus, the impact of significant AR on mortality after TAVI seems to be considerable in patients with reduced LVEF or high NT-pro BNP levels, but not those with preserved LVEF or low NT-pro BNP levels, suggesting that the influence of AR differs depending on the baseline LVEF and NT-pro BNP level.

  15. Prelingual auditory-perceptual skills as indicators of initial oral language development in deaf children with cochlear implants.

    Science.gov (United States)

    Pianesi, Federica; Scorpecci, Alessandro; Giannantonio, Sara; Micardi, Mariella; Resca, Alessandra; Marsella, Pasquale

    2016-03-01

    To assess when prelingually deaf children with a cochlear implant (CI) achieve the First Milestone of Oral Language, to study the progression of their prelingual auditory skills in the first year after CI and to investigate a possible correlation between such skills and the timing of initial oral language development. The sample included 44 prelingually deaf children (23 M and 21 F) from the same tertiary care institution, who received unilateral or bilateral cochlear implants. Achievement of the First Milestone of Oral Language (FMOL) was defined as speech comprehension of at least 50 words and speech production of a minimum of 10 words, as established by administration of a validated Italian test for the assessment of initial language competence in infants. Prelingual auditory-perceptual skills were assessed over time by means of a test battery consisting of: the Infant Toddler Meaningful Integration Scale (IT-MAIS); the Infant Listening Progress Profile (ILiP) and the Categories of Auditory Performance (CAP). On average, the 44 children received their CI at 24±9 months and experienced FMOL after 8±4 months of continuous CI use. The IT-MAIS, ILiP and CAP scores increased significantly over time, the greatest improvement occurring between baseline and six months of CI use. On multivariate regression analysis, age at diagnosis and age at CI did not appear to bear correlation with FMOL timing; instead, the only variables contributing to its variance were IT-MAIS and ILiP scores after six months of CI use, accounting for 43% and 55%, respectively. Prelingual auditory skills of implanted children assessed via a test battery six months after CI treatment, can act as indicators of the timing of initial oral language development. Accordingly, the period from CI switch-on to six months can be considered as a window of opportunity for appropriate intervention in children failing to show the expected progression of their auditory skills and who would have higher risk of

  16. Piezoelectric valve

    Science.gov (United States)

    Petrenko, Serhiy Fedorovich

    2013-01-15

    A motorized valve has a housing having an inlet and an outlet to be connected to a pipeline, a saddle connected with the housing, a turn plug having a rod, the turn plug cooperating with the saddle, and a drive for turning the valve body and formed as a piezoelectric drive, the piezoelectric drive including a piezoelectric generator of radially directed standing acoustic waves, which is connected with the housing and is connectable with a pulse current source, and a rotor operatively connected with the piezoelectric generator and kinematically connected with the rod of the turn plug so as to turn the turn plug when the rotor is actuated by the piezoelectric generator.

  17. Fracturing a dysfunctional Edwards Perimount bioprosthetic valve to facilitate percutaneous valve-in-valve placement of SAPIEN 3 valve with modified delivery system.

    Science.gov (United States)

    Shahanavaz, Shabana; Rockefeller, Toby; Nicolas, Ramzi; Balzer, David

    2017-10-10

    Pulmonary valve replacement via surgical implantation of a bioprosthetic valve (BPV) is a well-established treatment for patients with dysfunctional RV outflow tracts. BPVs are prone to structural deterioration, and will eventually require replacement. Recently, percutaneous valve-in-valve (VIV) placement of transcatheter valves has established itself as a safe and effective alternative to surgical revision. Unfortunately, VIV therapy is inherently limited by the inner diameter of the BPV, which restricts the number of eligible patients. Other centers have reported on the feasibility of cracking certain BPVs with ultra high-pressure balloons in bench testing. We now report cracking an Edwards Perimount BPV in the pulmonary position to facilitate VIV placement of an Edwards SAPIEN 3. The ability to crack the Perimount valve allowed placement of a larger valve than previously considered and minimized the final valve gradient. In an effort to avoid the morbidity and mortality of surgical pulmonary valve replacement, this new strategy will expand the number of patients eligible for percutaneous VIV therapy. © 2017 Wiley Periodicals, Inc.

  18. Effect of transcatheter aortic valve size and position on valve-in-valve hemodynamics: An in vitro study.

    Science.gov (United States)

    Azadani, Ali N; Reardon, Michael; Simonato, Matheus; Aldea, Gabriel; Nickenig, Georg; Kornowski, Ran; Dvir, Danny

    2017-06-01

    Transcatheter heart valve implantation in failed aortic bioprostheses (valve-in-valve [ViV]) is an increasingly used therapeutic option for high-risk patients. However, high postprocedural gradients are a significant limitation of aortic ViV. Our objective was to evaluate Medtronic CoreValve Evolut R ViV hemodynamics in relation to the degree of device oversizing and depth of implantation. Evolut R devices of 23 and 26 mm were implanted within 21-, 23-, and 25-mm Hancock II bioprostheses. Small and gradual changes in implantation depth were attempted. Hemodynamic testing was performed in a pulse duplicator under ISO-5840 standard. A total of 47 bench-testing experiments were performed. The mean gradient of the 26-mm Evolut R in 23- and 25-mm Hancock II was lower than 23-mm Evolut R (P  17.5 mm. The current comprehensive bench-testing assessment demonstrates the importance of both transcatheter heart valve size and device position for the attainment of optimal hemodynamics during ViV procedures. Additional in vitro testing may be required to develop hemodynamics-based guidelines for device sizing in ViV procedures in degenerated surgical bioprostheses. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  19. Valve's Way

    DEFF Research Database (Denmark)

    Foss, Nicolai Juul; Dobrajska, Magdalena

    2015-01-01

    to what extent it represents a new blueprint for organization design, despite it being consistent with an “egalitarian Zeitgeist” (Puranam, 2014). In fact, managerial authority may be of increasing importance rather than the opposite (Guadalupe, Li, & Wulf, 2015). Thus, Valve is, and will remain...

  20. Vacuum Valve

    CERN Multimedia

    1974-01-01

    This valve was used in the Intersecting Storage Rings (ISR) to protect against the shock waves that would be caused if air were to enter the vacuum tube. Some of the ISR chambers were very fragile, with very thin walls - a design required by physicists on the lookout for new particles.

  1. A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: THE Randomized, phase II study to evaluate the safety and pharmacokinetics of oral dabigatran etexilate in patients after heart valve replacement (RE-ALIGN).

    Science.gov (United States)

    Van de Werf, Frans; Brueckmann, Martina; Connolly, Stuart J; Friedman, Jeffrey; Granger, Christopher B; Härtter, Sebastian; Harper, Ruth; Kappetein, Arie Pieter; Lehr, Thorsten; Mack, Michael J; Noack, Herbert; Eikelboom, John W

    2012-06-01

    Vitamin K antagonists are the only oral anticoagulants approved for long-term treatment of patients with a cardiac valve replacement. This study aims to test a new dosing regimen for dabigatran etexilate in patients with a mechanical bileaflet valve. Patients aged ≥ 18 years and ≤ 75 years, either undergoing implantation of a mechanical bileaflet valve (aortic or mitral or both) during the current hospital stay or having undergone implantation a mitral bileaflet valve >3 months before randomization, will be randomized between dabigatran etexilate or warfarin (in a ratio of 2:1) in an open-label design. Initial doses of dabigatran will be based on the estimated creatinine clearance, and the doses will be adjusted based on measuring trough dabigatran plasma levels to achieve levels ≥ 50 ng/mL at steady state. Doses will range between 150 mg twice a day and 300 mg twice a day. Warfarin management and target international normalized ratio will be according to current practice guidelines at the discretion of the treating physicians. The plan is to treat 270 patients with dabigatran etexilate for a total study population of approximately 405 patients. Clinical efficacy and safety outcomes will be analyzed in an exploratory manner. RE-ALIGN is the first study to test an alternative to warfarin in patients with mechanical heart valves. A definitive phase III study will be planned based on the results of this study. Copyright © 2012 Mosby, Inc. All rights reserved.

  2. Initial experience with implantation of novel dual layer flow-diverter device FRED

    OpenAIRE

    Poncyljusz, Wojciech; Sagan, Leszek; Safranow, Krzysztof; Ra?, Monika

    2013-01-01

    Flow-diverting stents can help treat complex and wide-necked cerebral aneurysms. The aim of the study was to evaluate initial experiences related to the safety and effectiveness of eight aneurysms treated with a new dual layer coverage designed flow-diverter device. In 2012 Fred flow-diverter devices were used to treat 8 unruptured wide neck (dome-neck ratio ? 1.5) and sidewall aneurysms in 6 patients. All aneurysms were located in the anterior circulation on the internal carotid artery (ICA)...

  3. Hybrid textile heart valve prosthesis: preliminary in vitro evaluation.

    Science.gov (United States)

    Vaesken, Antoine; Pidancier, Christian; Chakfe, Nabil; Heim, Frederic

    2016-09-22

    Transcatheter aortic valve implantation (TAVI) is nowadays a popular alternative technique to surgical valve replacement for critical patients. Biological valve tissue has been used in these devices for over a decade now with over 100,000 implantations. However, material degradations due to crimping for catheter insertion purpose have been reported, and with only 6-year follow-up, no information is available about the long-term durability of biological tissue. Moreover, expensive biological tissue harvesting and chemical treatment procedures tend to promote the development of synthetic valve leaflet materials. Textile polyester (PET) material is characterized by outstanding folding and strength properties combined with proven biocompatibility and could therefore be considered as a candidate to replace biological valve leaflets in TAVI devices. Nevertheless, the material should be preferentially partly elastic in order to limit water hammer effects at valve closing time and prevent exaggerated stress from occurring into the stent and the valve. The purpose of the present work is to study in vitro the mechanical as well as the hydrodynamic behavior of a hybrid elastic textile valve device combining non-deformable PET yarn and elastic polyurethane (PU) yarn. The hybrid valve properties are compared with those of a non-elastic textile valve. Testing results show improved hydrodynamic properties with the elastic construction. However, under fatigue conditions, the interaction between PU and PET yarns tends to limit the valve durability.

  4. Implantable contraception.

    Science.gov (United States)

    Meckstroth, K R; Darney, P D

    2000-12-01

    Although levonorgestrel contraceptive implants have been available for over 15 years, innovations have only recently led to a wider choice. These new implants offer easier insertion and removal and other advantages depending on the type of progestin. Implants prevent pregnancy by several mechanisms, including inhibition of ovulation and luteal function and alteration of cervical mucus and the endometrium. The high efficacy and ease of maintenance make implants an ideal contraceptive for many women, including adolescents, a population that uses implants infrequently but reports high satisfaction. Implants are appropriate for women who are breastfeeding, who have contraindications to estrogen, or who have diseases such as diabetes, hypertension, sickle cell anemia, or an HIV infection because implants have few metabolic or hematologic effects. Long-term use has not been associated with a decrease in BMD and generally leads to increased blood levels and iron stores. Women who wish to space their pregnancies appreciate the nearly immediate onset of action with insertion and the rapid termination of all effects with removal. All types of implants lead to menstrual changes and other side effects in some women. Adverse effects that occur in implant users more than the general population include headaches and acne. Women must be thoroughly counseled regarding the potential for menstrual alteration, side effects, and sexually transmitted infections if they do not use condoms. Despite their initial high cost, implants are a cost-effective method over several years, even when discontinued before the life of the implant.

  5. Anesthesia management for MitraClip device implantation

    Directory of Open Access Journals (Sweden)

    Harikrishnan Kothandan

    2014-01-01

    Full Text Available Aims and Objectives: Percutaneous MitraClip implantation has been demonstrated as an alternative procedure in high-risk patients with symptomatic severe mitral regurgitation (MR who are not suitable (or denied mitral valve repair/replacement due to excessive co morbidity. The MitraClip implantation was performed under general anesthesia and with 3-dimensional transesophageal echocardiography (TEE and fluoroscopic guidance. Materials and Methods: Peri-operative patient data were extracted from the electronic and paper medical records of 21 patients who underwent MitraClip implantations. Results: Four MitraClip implantation were performed in the catheterization laboratory; remaining 17 were performed in the hybrid operating theatre. In 2 patients, procedure was aborted, in one due to migration of the Chiari network into the left atrium and in second one, the leaflets and chords of the mitral valve torn during clipping resulting in consideration for open surgery. In the remaining 19 patients, MitraClip was implanted and the patients showed acute reduction of severe MR to mild-moderate MR. All the patients had invasive blood pressure monitoring and the initial six patients had central venous catheterization prior to the procedure. Intravenous heparin was administered after the guiding catheter was introduced through the inter-atrial septum and activated clotting time was maintained beyond 250 s throughout the procedure. Protamine was administered at the end of the procedure. All the patients were monitored in the intensive care unit after the procedure. Conclusions: Percutaneous MitraClip implantation is a feasible alternative in high-risk patients with symptomatic severe MR. Anesthesia management requirements are similar to open surgical mitral valve repair or replacement. TEE plays a vital role during the MitraClip implantation.

  6. A New Hemostasis Valve for Neuroendovascular Procedures

    Science.gov (United States)

    Namba, K.; Song, J.K.; Niimi, Y.; Heran, N.S.; Berenstein, A.

    2007-01-01

    Summary A hemostasis valve is routinely used in neuroendovascular procedures to decrease the risk of thromboembolism1,2. Recently, a new hemostasis valve that is designed to minimize blood loss has been introduced. We report our initial experience in using this new hemostasis valve. In neuroendovascular procedures, a hemostasis valve is commonly used for continuous irrigation of guide and microcatheters to decrease the risk of thromboembolism1,2,3. A conventional hemostasis valve has a rotating seal at the end, which is turned open or closed each time a wire or microcatheter/guidewire is introduced or extracted. Often this results in significant back bleeding. When a rotating seal is adjusted suboptimally during a wire or microcatheter manipulation, leakage of pressurized saline from the end of a hemostasis valve results in stagnation of blood within a guiding catheter, which becomes a potential source of emboli during a procedure. The Guardian Haemostasis Valve (Zerusa Limited, Galway, Ireland) is a new hemostasis valve that is designed to minimize blood loss during interventional procedures by minimizing the opening time of the valve during wire or microcatheter insertion. A continuous sealing mechanism during wire or microcatheter positioning minimizes blood loss and stagnation of blood within the guide catheter. We report our initial experience with the Guardian hemostasis valve. PMID:20566129

  7. Transseptal transcatheter mitral valve-in-valve: A step by step guide from preprocedural planning to postprocedural care.

    Science.gov (United States)

    Guerrero, Mayra; Salinger, Michael; Pursnani, Amit; Pearson, Paul; Lampert, Mark; Levisay, Justin; Russell, Hyde; Feldman, Ted

    2017-05-30

    Transcatheter mitral valve replacement has been successfully performed with the use of aortic transcatheter heart valves in hundreds of patients worldwide with severe dysfunction of a degenerated mitral bioprosthesis and high surgical risk for repeat operation. The delivery approach in the vast majority of the mitral valve-in-valve procedures has been transapical. Although the transseptal approach may be more technically challenging, it is less invasive and may be preferred by patients. Data from case series and a large international registry suggest that patients treated with transseptal mitral valve-in-valve have faster recovery, more improvement in left ventricular ejection fraction and possibly lower mortality compared with patients treated with transapical approach. A prospective clinical trial, the MITRAL trial (Mitral Implantation of TRAnscatheter vaLves) is evaluating the safety and feasibility of transvenous transseptal mitral valve-in-valve. The experience from this trial has allowed us to improve our procedural approach. In anticipation of a wider adoption of the transseptal approach for mitral valve-in-valve, we describe our current method step-by-step from planning the procedure through postprocedural management. This is an evolving technique that has changed with experience and the transition to newer generation transcatheter heart valve devices. We discuss the use of cardiac computed tomography for planning the procedure including transseptal puncture and valve size selection, provide procedural and technical tips, and discuss postprocedural care. © 2017 Wiley Periodicals, Inc.

  8. Butterfly valve. Spjeldventil

    Energy Technology Data Exchange (ETDEWEB)

    Cupedo, D.J.

    1984-02-06

    Butterfly valve comprising a body and a valve seat arranged therein, on which a valve member is supported. The valve member comprises an operating rod and the assembly of valve member and operating rod has a fixed pivot point at the bottom of the body. The operating rod can be moved by means of pins movable in grooves and slots in such a manner that when the valve is opened the valve member first pivots about the pivot point to lift the valve member from the seat and subsequently rotates about the pivot point to fully open the valve. 12 drawings.

  9. Direct aortic access for transcatheter aortic valve replacement with a fully repositionable and retrievable nonmetallic valve system.

    Science.gov (United States)

    Bushnaq, Hasan; Metz, Dietrich; Petrov, Asen; Frantz, Stefan; Hofmann, Ulrich; Raspé, Christoph; Treede, Hendrik

    2016-12-01

    The standard procedure of transcatheter aortic valve implantation involves transfemoral access. Nevertheless, the use of this access route is limited by the vessel diameter, calcification, and tortuosity, making a subgroup of patients ineligible for peripheral access. We report the first use of direct aortic transcatheter aortic valve implantation with the Direct Flow Medical valve (Direct Flow Medical, Inc, Santa Rosa, Calif) in 15 patients at the Halle-Wittenberg University. Between January 2014 and May 2015, 55 patients with severe aortic valve disease underwent transcatheter aortic valve implantation with the Direct Flow Medical valve at the Halle-Wittenberg University. Subgroups of 15 patients were treated using direct aortic access because of small vessel diameter, excessive calcification, or extreme tortuosity of the iliofemoral vessels. The mean patient age was 79.1 ± 6.72 years, and 10 patients (66%) were male. The mean logistic European System for Cardiac Operative Risk Evaluation was 23.4% ± 16.9%, and the mean Society of Thoracic Surgeons score was 7.8% ± 6.8%. Access related to redo-sternotomy during transcatheter aortic valve implantation was required in 4 patients (27%). Valve retrieval was performed in 2 patients (13%). There was no conversion to surgical aortic valve replacement and no incidence of major stroke. The postimplant mean gradient was 9.3 ± 2.5 mm Hg. No patient had moderate or severe paravalvular leakage. All patients survived the first 30 days. Direct aortic access seems to be a feasible and safe endovascular alternative for implantation of the Direct Flow Medical valve. This access provides direct and accurate control of the entire implantation procedure. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  10. Transcatheter Aortic Valve Replacement Using the Portico System

    DEFF Research Database (Denmark)

    Tzikas, Apostolos; Amrane, Hafid; Bedogni, Francesco

    2016-01-01

    The Portico system (St. Jude Medical, Minneapolis, MN, USA) consists of a self-expanding valve prosthesis and a delivery system designed for transcatheter aortic valve replacement (TAVR). We describe this system, its 10-steps implantation procedure, and provide tips and tricks based on our person...

  11. Durability of pericardial versus porcine bioprosthetic heart valves.

    Science.gov (United States)

    Grunkemeier, Gary L; Furnary, Anthony P; Wu, YingXing; Wang, Lian; Starr, Albert

    2012-12-01

    To compare the probability, and modes, of explantation for Carpentier-Edwards pericardial versus porcine valves. Our porcine series began in 1974 and our pericardial series in 1991, with annual prospective follow-up. We used the Kaplan-Meier method and Cox regression for estimation and analysis of patient mortality, and the cumulative incidence function and competing risks regression for estimation and analysis of valve durability. Through the end of 2010, we had implanted 506 porcine and 2449 pericardial aortic valves and 181 porcine and 163 pericardial mitral valves. The corresponding total and maximum follow-up years were 3471 and 24, 11,517 and 18, 864 and 22, and 645 and 9. The corresponding probabilities (cumulative incidence function) of any valve explant were 7%, 8%, 22%, and 8%, and of explant for structural valve deterioration were 4%, 5%, 16%, and 5% at 15 years for the first 3 series and at 8 years for the fourth (pericardial mitral valve) series. Using competing risks regression for structural valve deterioration explant, with age, gender, valve size, and concomitant coronary bypass surgery as covariates, a slight (subhazard ratio, 0.79), but nonsignificant, protective effect was found for the pericardial valve in the aortic position and a greater (subhazard ratio, 0.31) and almost significant (P = .08) protective effect of the pericardial valve in the mitral position. Leaflet tear was responsible for 61% of the structural valve deterioration explants in the porcine series and 46% in the pericardial series. Using competing risks regression, the pericardial valve had a subhazard ratio for structural valve deterioration explant of less than 1 in both positions, approaching statistical significance in the mitral position. The mode of structural valve deterioration was predominantly leaflet tear for porcine valves and fibrosis/calcification for pericardial valves. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc

  12. Impact of New-generation Hybrid Imaging Technology on Radiation Dose during Percutaneous Coronary Interventions and Trans-femoral Aortic Valve Implantations: A comparison with conventional flat-plate angiography.

    Science.gov (United States)

    Boland, John E; Wang, Louis W; Love, Bernard J; Christofi, Marino; Muller, David W M

    2016-07-01

    Technological advancements in newer-generation catheterisation laboratories may reduce patient and occupational radiation exposure. We compared fluoroscopy time and dose-area product (DAP) between a Philips Allura X-PER FD20 and Siemens Artis Zeego Hybrid systems for 47 single-vessel percutaneous coronary interventions (PCI) and 35 transcatheter aortic valve implantations (21 Corevalve, 14 Edwards Sapien TAVI) using the FD20, versus 30 PCI and 28 TAVI (15 Corevalve, 13 Sapien) with the Zeego over a 24-month period. Multivariate analysis revealed that, adjusting for patient weight and fluoroscopy time, DAP (median, interquartile range) was 26% lower for PCI with the Zeego than the FD20 [55.6 (27.0-91.5) vs 77.6 (51.2-129.1) Gy.cm(2), P=0.03)] and using tomographic imaging with the Zeego did not increase DAP for TAVI procedures [98.1 (65.9-136.6) vs 112.4 (64.9-156.2) Gy.cm(2) (P=NS). Although fluoroscopy times were longer for TAVI procedures than PCI with both systems (23.5-24.4 vs 7.3-9.2mins, pvalve replacement procedures use additional cine-acquisition not necessary for PCI. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

  13. Mechanism of valve failure and efficacy of reintervention through catheterization in patients with bioprosthetic valves in the pulmonary position

    Directory of Open Access Journals (Sweden)

    Ryan Callahan

    2017-01-01

    Conclusion: Failing surgically implanted BPVs demonstrate leaflet calcification, thickness, and immobility leading to PS and/or regurgitation while the mechanism of TPV failure in the short- to mid-term is stenosis, mainly from loss of stent integrity. This can be effectively treated with a catheter.based approach, predominantly with the valve-in-valve technique.

  14. Stentless aortic valve replacement: an update

    Directory of Open Access Journals (Sweden)

    Kobayashi J

    2011-06-01

    Full Text Available Junjiro KobayashiDepartment of Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Osaka, JapanAbstract: Although porcine aortic valves or pericardial tissue mounted on a stent have made implantation techniques easier, these valves sacrifice orifice area and increase stress at the attachment of the stent, which causes primary tissue failure. Optimizing hemodynamics to prevent patient–prosthetic mismatch and improve durability, stentless bioprostheses use was revived in the early 1990s. The purpose of this review is to provide a current overview of stentless valves in the aortic position. Retrospective and prospective randomized controlled studies showed similar operative mortality and morbidity in stented and stentless aortic valve replacement (AVR, though stentless AVR required longer cross-clamp and cardiopulmonary bypass time. Several cohort studies showed improved survival after stentless AVR, probably due to better hemodynamic performance and earlier left ventricular (LV mass regression compared with stented AVR. However, there was a bias of operation age and nonrandomization. A randomized trial supported an improved 8-year survival of patients with the Freestyle or Toronto valves compared with Carpentier–Edwards porcine valves. On the contrary, another randomized study did not show improved clinical outcomes up to 12 years. Freedom from reoperation at 12 years in Toronto stentless porcine valves ranged from 69% to 75%, which is much lower than for Carpentier–Edwards Perimount valves. Cusp tear with consequent aortic regurgitation was the most common cause of structural valve deterioration. Cryolife O'Brien valves also have shorter durability compared with stent valves. Actuarial freedom from reoperation was 44% at 10 years. Early prosthetic valve failure was also reported in patients who underwent root replacement with Shelhigh stentless composite grafts. There was no level I or IIa evidence of more effective orifice

  15. Resurgery for recurrent heart valve diseases

    Directory of Open Access Journals (Sweden)

    Chong-lei REN

    2017-02-01

    Full Text Available Objective To summarize the experience with resurgery for recurrent valvular heart diseases. Methods From June 2004 to June 2015, 28 patients (15 males and 13 females with ages ranging from 44 to 67 years (55.6±6.5 years with recurrent heart valve disease underwent resurgery. The reasons for resurgery included perivalvular leakage (7 cases, bioprosthetic valve decline (6 cases in mitral valve and 3 in tricuspid valve, mechanical prostheses dysfunction (2cases, infective endocarditis after valve replacement (2 cases, restenosis of repaired native valve (1 case, and severe tricuspid insufficiency after left-side valve surgery (7 cases. Resurgery included mitral valve replacement in 18 patients and tricuspid valve replacement in 10. All the patients underwent third or fourth or even fifth cardiac surgery for valve replacement. Results There were 2 hospital deaths with a mortality of 7.1% (2/28. The main causes of early-stage deaths were low cardiac output syndrome. The main postoperative complications were respiratory failure in 3, low cardiac output syndrome in 2, reexploration for bleeding in 2 and serious infectious shock in 1. All the patients were found with the great improvement in heart function and the re-implanted prostheses worked well during follow-up. Conclusions Although resurgery for recurrent heart valve disease poses a continuing challenge to cardiac surgeon, it could be performed with the satisfactory results. The keys to a successful cardiac resurgery include appropriate operational timing, refined surgical technique and reasonable perioperative managements. DOI: 10.11855/j.issn.0577-7402.2017.01.11

  16. Aortic Valve Stenosis

    Science.gov (United States)

    ... rapid, fluttering heartbeat Not eating enough (mainly in children with aortic valve stenosis) Not gaining enough weight (mainly in children with aortic valve stenosis) The heart-weakening effects of aortic valve stenosis ...

  17. Aortic Annular Enlargement during Aortic Valve Replacement

    OpenAIRE

    Selman Dumani; Ermal Likaj; Laureta Dibra; Stavri Llazo; Ali Refatllari

    2016-01-01

    In the surgery of aortic valve replacement is always attempted, as much as possible, to implant the larger prosthesis with the mains goals to enhance the potential benefits, to minimise transvalvular gradient, decrease left ventricular size and avoid the phenomenon of patient-prosthesis mismatch. Implantation of an ideal prosthesis often it is not possible, due to a small aortic annulus. A variety of aortic annulus enlargement techniques is reported to avoid patient-prosthesis mismatch. We pr...

  18. Effect of permanent pacemaker on mortality after transcatheter aortic valve replacement

    DEFF Research Database (Denmark)

    Engborg, Jonathan; Riechel-Sarup, Casper; Gerke, Oke

    2017-01-01

    OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an established treatment for high-grade aortic valve stenosis in patients found unfit for open heart surgery. The method may cause cardiac conduction disorders requiring permanent pacemaker (PPM) implantation, and the long-term effect ...

  19. Mechanical heart valve cavitation in patients with bileaflet valves.

    Science.gov (United States)

    Johansen, Peter; Andersen, Tina S; Hasenkam, J Michael; Nygaard, Hans; Paulsen, Peter K

    2014-01-01

    Today, the quality of mechanical heart valves is quite high, and implantation has become a routine clinical procedure with a low operative mortality (mechanism found to be a possible contributor to these adverse effects is cavitation. In vitro, cavitation has been directly demonstrated by visualization and indirectly in vivo by registering of high frequency pressure fluctuations (HFPF). Tilting disc valves are thought of having higher cavitation potential than bileaflet valves due to higher closing velocities. However, the thromboembolic potential seems to be the same. Further studies are therefore needed to investigate the cavitation potential of bileaflet valves in vivo. The post processing of HFPF have shown difficulties when applied on bileaflet vavles due to asynchronous closure of the two leaflets. The aim of this study was therefore to isolate the pressure signature from each leaflet closure and perform cavitation analyses on each component. Six patients were included in the study (St. Jude Medical (n=3) and CarboMedics (n=3); all aortic bileaflet mechanical heart valves). HFPFs were recorded intraoperatively through a hydrophone at the aortic root. The pressure signature relating to the first and second leaflet closure was isolated and cavitation parameters were calculated (RMS after 50 kHz highpass filtering and signal energy). Data were averaged over 30 heart cycles. For all patients both the RMS value and signal energy of the second leaflet closure were higher than for the first leaflet closure. This indicates that the second leaflet closure is most prone to cause cavitation. Therefore, quantifying cavitation based on the HFPF related to the second leaflet closure may suggest that the cavitation potential for bileaflet valves in vivo may be higher than previous studies have suggested.

  20. A novel approach for endocardial resynchronization therapy: Initial experience with transapical implantation of the left ventricular lead

    NARCIS (Netherlands)

    I. Kassai (Imre); A. Mihalcz (Attila); C. Foldesi (Csaba); A. Kardos (Attila); T. Szili-Torok (Tamas)

    2009-01-01

    textabstractBackground: Coronary sinus lead placement for transvenous left ventricular (LV) pacing in cardiac resynchronization therapy (CRT) has a significant failure rate at implant and a considerable dislocation rate during follow-up. For these patients epicardial pacing lead implantation is the

  1. What Is Heart Valve Disease?

    Science.gov (United States)

    ... Heart Valves Sometimes heart valves can’t be repaired and must be replaced. This surgery involves removing the faulty valve and replacing it with a man-made or biological valve. Biological valves are made ...

  2. Transcatheter pulmonary valve replacement by hybrid approach using a novel polymeric prosthetic heart valve: proof of concept in sheep.

    Directory of Open Access Journals (Sweden)

    Ben Zhang

    Full Text Available 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

  3. Multidisciplinary optimization of a butterfly valve.

    Science.gov (United States)

    Song, Xue Guan; Wang, Lin; Baek, Seok Heum; Park, Young Chul

    2009-07-01

    A butterfly valve is a type of flow control device, typically used to regulate fluid flow. This paper proposes a new process to meet desired needs in valve design that is characterized by the complex configuration. First, the need is identified according to the valve user/company, and then the problem is defined with a characteristic function. Second, the initial model of valve is made, and then the initial analysis including fluid and/or structural analysis is carried out to predict the fluid and/or structural performance of the valve. Third, the optimization in the form of mathematical functions, which considers single or multiple objective and/or discipline, is handled. This part includes the design of computer experiment, approximation technique, topology optimization and sizing optimization. Finally, the validation experiment is conducted based on the optimum result to verify the accuracy of the optimization. An example is provided to confirm the availability of the process proposed here.

  4. Cochlear Implants

    Science.gov (United States)

    ... implant procedure Welcome to the Food and Drug Administration (FDA) website on cochlear implants. Cochlear implants are electronic hearing devices. Doctors implant cochlear implants into people ...

  5. Symetis Acurate Neo transfemoral aortic bioprosthesis - initial Polish experience.

    Science.gov (United States)

    Zembala, Michał; Hawranek, Michał; Wacławski, Jacek; Niklewski, Tomasz; Nadziakiewicz, Paweł; Koba, Rafał; Przybylski, Roman; Walas, Ryszard; Głowacki, Jan; Jazwiec, Tomasz; Garbacz, Marcin; Gąsior, Mariusz; Zembala, Marian

    2016-01-01

    Transcatheter aortic valve implantation (TAVI) has proven to be a valuable alternative to conventional surgical aortic valve replacement in high-risk and surgically inoperable patients who suffer from severe symptomatic aortic stenosis. With the second generation of TAVI devices improvements in both handling and performance are highly demanded. This brief clinical communication reports the first Polish experience with the second generation of transfemoral TAVI device--Symetis Acurate Neo. From November 19th 2014 until February 18th 2015 nine (n = 9) patients with severe symptomatic aortic stenosis have been operated on using the Symetis Acurate Neo. Patients were subject to seven-day evaluation and 30-day phone follow-up. The procedure was safely and successfully performed in all patients. A SMALL (S) valve (21-23 mm equivalent) was used in two patients, MEDIUM valve (M; 23-25 mm equivalent) in five patients, and a LARGE valve (L; 25-26 mm equivalent) in two patients. In three cases post-release balloon dilatation was required. There were no intraoperative complications and no major adverse events (as per VARC classification) during initial hospitalisation, including conduction or rhythm disturbances. In all cases, the mean gradient on the prosthetic valves was 7.8 mm Hg (10.2 mm Hg on the "S" valves). Rapid improvement in patients' functional class was noted. Perivalvular leak was evaluated as "mild" in three cases, "trace" in one, and "not existing" in five. This initial experience with the Symetis Acurate Neo demonstrates its good safety profile and excellent haemodynamics. Low radial stress of the valve results in minimal incidence of atrioventricular rhythm disturbances, and a sealing crown for nearly non-existent paravalvular leak.

  6. Morphological characteristics of tissues of anterior abdominal wall of rats after implantation of alloplastic material, processed with collagen, in the initially infected wounds

    OpenAIRE

    Svisenko O.V.

    2010-01-01

    A research purpose was to investigate the tissue reactions on implantation of polypropylene mesh, processed with collagen, after the plastic of experimental defect at rats at underaponevrotic localization of prosthesis in the initially infected wounds. Research was performed in two experimental groups. Group 1 – at 27 rats in the conditions of the infected wound the monofilamentous polypropylene mesh of size 1×1,5 sm was fixed under aponevrosis. Group 2 – at 27 rats at analogous conditions wi...

  7. Mitral valve regurgitation

    Science.gov (United States)

    ... around the valve. You are at risk for mitral valve regurgitation if you have: Coronary heart disease and high blood pressure Infection of the heart valves Mitral valve prolapse (MVP) Rare conditions, such as untreated syphilis or Marfan ... heart disease. This is a complication of untreated strep throat ...

  8. Tissue engineered aortic valve

    OpenAIRE

    Dohmen, P M

    2012-01-01

    Several prostheses are available to replace degenerative diseased aortic valves with unique advantages and disadvantages. Bioprotheses show excellent hemodynamic behavior and low risk of thromboembolic complications, but are limited by tissue deterioration. Mechanical heart valves have extended durability, but permanent anticoagulation is mandatory. Tissue engineering created a new generation heart valve, which overcome limitations of biological and mechanical heart valves due to remodelling,...

  9. Incidência de trombo intracardíaco e de tromboembolismo nos três primeiros meses após o implante de bioprótese valvar Incidence of intracardiac thrombus and thromboembolism in the first three months after bioprosthetic valve implantation

    Directory of Open Access Journals (Sweden)

    Auristela Isabel de Oliveira Ramos

    2004-12-01

    Full Text Available OBJETIVO: Avaliar a incidência de trombo intracardíaco e de tromboembolismo nos três primeiros meses após a troca valvar por bioprótese e identificar fatores de risco para a formação de trombo. MÉTODO:Incluídos 184 pacientes, entre 15 e 75 anos de idade, submetidos a implante de bioprótese e realizados ecocardiogramas transtorácico e transesofágico (ETE na fase hospitalar, média 8,4±3 dias, e três meses após, média 97,4±21,7 dias. RESULTADOS: Incidência de trombo foi significativamente mais elevada nos pacientes com prótese em posição mitral ou mitroaórtica (21,0% do que em posição aórtica (2,8%, pOBJECTIVE: To assess the incidence of intracardiac thrombus and thromboembolism in the first 3 months after bioprosthetic valve replacement and to identify the risk factors for thrombus formation. METHODS: The study comprised 184 patients, aged between 15 and 75 years, who underwent bioprosthetic valve implantation. Transthoracic and transesophageal (TEE echocardiographies were performed in the in-hospital phase (mean, 8.4±3 days and after 3 months (mean, 97.4±21.7 days. RESULTS: The incidence of thrombus was significantly greater in patients with a prosthesis in the mitral or mitroaortic position (21.0% than in those with a prosthesis in the aortic position (2.8%, P<0.001. The multiple logistic regression identified the prosthesis in the mitral or mitroaortic position as the only independent variable for thrombus formation. On the 3-month follow-up, TEE showed a thrombus in 35 (20.7% of the 169 patients on echocardiographic assessment, 31.7% in mitral patients and 3.1% in aortic patien