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Aortic paravalvular leak

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https://www.readbyqxmd.com/read/28651336/safety-and-efficacy-of-a-repositionable-and-fully-retrievable-aortic-valve-used-in-routine-clinical-practice-the-respond-study
#1
Volkmar Falk, Jochen Wöhrle, David Hildick-Smith, Sabine Bleiziffer, Daniel J Blackman, Mohamed Abdel-Wahab, Ulrich Gerckens, Axel Linke, Hüseyin Ince, Peter Wenaweser, Dominic J Allocco, Keith D Dawkins, Nicolas M Van Mieghem
Aims: RESPOND is a prospective, open-label, single-arm study evaluating the outcomes following transcatheter aortic valve implantation (TAVI) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis. Methods and results: RESPOND enrolled 1014 patients at sites across Europe, New Zealand, and Latin America; 996 patients received a Lotus Valve (mean age: 80.8 years; 50.8% female; Society of Thoracic Surgeons score: 6...
June 22, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28648426/percutaneous-closure-of-symptomatic-large-tricuspid-paravalvular-regurgitation-using-two-muscular-vsd-occluders
#2
Aritra Mukherji, Rajaram Anantharaman, Raghavan Subramanyan
Paravalvular leaks are common following valve replacement surgery. Majority are benign and do not require any active intervention. However, occasionally severe paravalvular regurgitation can produce heart failure and/or hemolysis, needing closure of the defect. It is more commonly associated with aortic and mitral prosthesis, symptomatic tricuspid paravalvular regurgitation being a rare entity. In this report we present the successful percutaneous transcatheter closure of a large paravalvular tricuspid regurgitation in a 59-year old lady with history of multiple previous operations...
May 2017: Indian Heart Journal
https://www.readbyqxmd.com/read/28622047/repositionable-and-retrievable-lotus-valve-system-for-the-treatment-of-bicuspid-aortic-stenosis-is-it-time-to-treat-all-valves
#3
Roberto Nerla, Fausto Castriota, Antonio Micari, Estevao de Campos Martins, Alberto Cremonesi
INTRODUCTION: For a long time, a bicuspid valve has been considered a contraindication to transcatheter aortic valve implantation (TAVI) due to worse procedural results. Currently available technologies are changing the scenario, with initial experiences reporting much better results with second-generation devices. AREAS COVERED: This review will analyze the risk and potential pitfalls of TAVI on bicuspid valves and will try ascertain how the use of a new-generation fully repositionable device, the Lotus Valve System (LVS), could improve procedural and clinical results in bicuspid anatomies...
June 16, 2017: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/28605428/the-commence-trial-2-year-outcomes-with-an-aortic-bioprosthesis-with-resilia-tissue%C3%A2
#4
John D Puskas, Joseph E Bavaria, Lars G Svensson, Eugene H Blackstone, Bartley Griffith, James S Gammie, David A Heimansohn, Jerzy Sadowski, Krzysztof Bartus, Douglas R Johnston, Jacek Rozanski, Todd Rosengart, Leonard N Girardi, Charles T Klodell, Mubashir A Mumtaz, Hiroo Takayama, Michael Halkos, Vaughn Starnes, Percy Boateng, Tomasz A Timek, William Ryan, Shuab Omer, Craig R Smith
OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR). METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre ( n  = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory...
June 10, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/28598875/early-hemodynamic-results-in-patients-with-small-aortic-annulus-after-aortic-valve-replacement
#5
Pierre Olivier Dionne, Frédéric Poulin, Denis Bouchard, Philippe Généreux, Reda Ibrahim, Raymond Cartier, Yoan Lamarche, Philippe Demers
OBJECTIVE: Patients with a small aortic annulus (≤21 mm) have an increased risk of patient-prosthesis mismatch after valve replacement. The aim of this study was to compare the early hemodynamic performance of the balloon-expandable transaortic valve implantation Edwards system (SAPIEN) and the sutureless Perceval prostheses. METHODS: Fifty patients underwent transcatheter aortic valve implantation, and 113 patients underwent sutureless aortic valve replacement...
June 8, 2017: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
https://www.readbyqxmd.com/read/28595747/transcathether-aortic-valve-implantation-with-the-new-repositionable-self-expandable-evolut-r-versus-corevalve-system-a-case-matched-comparison
#6
Cristina Giannini, Marco De Carlo, Corrado Tamburino, Federica Ettori, Azeem M Latib, Francesco Bedogni, Giuseppe Bruschi, Patrizia Presbitero, Arnaldo Poli, Franco Fabbiocchi, Roberto Violini, Carlo Trani, Pietro Giudice, Marco Barbanti, Marianna Adamo, Paola Colombo, Susanna Benincasa, Mauro Agnifili, A Sonia Petronio
BACKGROUND: Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. METHODS: Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n=1846) or Evolut R (n=302) were prospectively included in the Italian TAVI ClinicalService® project...
May 29, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28555592/repositionable-percutaneous-aortic-valve-implantation-with-the-lotus-valve-30-day-and-1-year-outcomes-in-250-high-risk-surgical-patients
#7
Ian T Meredith, Nicolas Dumonteil, Daniel J Blackman, Didier Tchétché, Darren L Walters, David Hildick-Smith, Ganesh Manoharan, Jan Harnek, Stephen G Worthley, Gilles Rioufol, Thierry Lefèvre, Thomas Modine, Nicolas M Van Mieghem, Ted Feldman, Dominic J Allocco, Keith D Dawkins
AIMS: The REPRISE IIE trial evaluated outcomes following transcatheter aortic valve implantation of the fully repositionable and retrievable Lotus Valve with a unique seal designed to minimize paravalvular leak (PVL). METHODS AND RESULTS: This prospective, multicentre study enrolled 250 patients with severe aortic stenosis considered high-risk for surgery by a multidisciplinary Heart Team. An independent Clinical Events Committee adjudicated events per Valve Academic Research Consortium criteria...
May 30, 2017: EuroIntervention
https://www.readbyqxmd.com/read/28549026/the-use-of-rapid-deployment-valves-in-combined-aortic-and-mitral-valve-surgery-one-year-clinical-and-echocardiographic-outcomes
#8
Markus Schlömicher, Matthias Bechtel, Zulfugar Taghiyev, Yazan Al-Jabery, Peter Lukas Haldenwang, Vadim Moustafine, Justus Thomas Strauch
OBJECTIVE: Patients undergoing multiple valve surgery represent a high-risk group who could potentially benefit from a reduction of cross-clamp and cardiopulmonary bypass times because prolonged bypass and cross-clamp times are considered independent risk factors for increased morbidity and mortality after cardiac surgery. METHODS: Between July 2013 and November 2014, 16 patients underwent rapid deployment aortic valve replacement with the EDWARDS INTUITY valve system in the setting of concomitant mitral disease...
May 2017: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery
https://www.readbyqxmd.com/read/28544832/percutaneous-antegrade-trans-septal-closure-of-mitral-paravalvular-leak-without-creation-of-an-arteriovenous-wire-loop-in-patients-with-coexistent-mechanical-aortic-valve
#9
Teoman Kilic, Senol Coskun, Kurtulus Karauzum, Sadan Yavuz, Tayfun Sahin
BACKGROUND: Various approaches such as antegrade trans-septal, retrograde transfemoral and transapical techniques have been used to close mitral paravalvular leak (PVL) in patients with an aortic prosthesis. During the implementation of these techniques, an arteriovenous guidewire loop is often created for device delivery. However, passing through a mechanical aortic valve may cause hemodynamic compromise and prolong the procedure. To date, no studies have evaluated antegrade mitral PVL closure without the use of an arteriovenous wire loop in patients with a mechanical aortic prosthesis...
January 2017: Journal of Heart Valve Disease
https://www.readbyqxmd.com/read/28535962/predictors-of-paravalvular-regurgitation-after-implantation-of-the-fully-repositionable-and-retrievable-lotus-transcatheter-aortic-valve-from-the-reprise-ii-trial-extended-cohort
#10
Daniel J Blackman, Ian T Meredith, Nicolas Dumonteil, Didier Tchétché, David Hildick-Smith, Mark S Spence, Darren L Walters, Jan Harnek, Stephen G Worthley, Gilles Rioufol, Thierry Lefèvre, Vicki M Houle, Dominic J Allocco, Keith D Dawkins
Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis...
July 15, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28493389/contemporary-transcatheter-aortic-valve-replacement-with-third-generation-balloon-expandable-versus-self-expanding-devices
#11
Toby Rogers, Arie Steinvil, Kyle Buchanan, M Chadi Alraies, Edward Koifman, Jiaxiang Gai, Rebecca Torguson, Petros Okubagzi, Itsik Ben-Dor, Augusto Pichard, Lowell Satler, Ron Waksman
OBJECTIVES: To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes. BACKGROUND: Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices. METHODS: 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included...
May 11, 2017: Journal of Interventional Cardiology
https://www.readbyqxmd.com/read/28493342/rapid-deployment-aortic-valve-replacement-versus-standard-bioprosthesis-implantation
#12
Enrico Ferrari, Christelle Roduit, Pauline Salamin, Elena Caporali, Stefanos Demertzis, Piergiorgio Tozzi, Denis Berdajs, Ludwig von Segesser
OBJECTIVE: To compare the outcome and the 1-year hemodynamic results of the rapid-deployment Intuity valve versus the Perimount Magna bioprosthesis in matched populations. METHODS: Between March 2014 and May 2015, 32 patients underwent aortic valve replacement with the Intuity valve (Intuity-group). These patients were compared to a matched population of Perimount valves implanted during the same period of time (Perimount-group). Clinical data were compared and echocardiographic 1-year follow-up was performed...
May 11, 2017: Journal of Cardiac Surgery
https://www.readbyqxmd.com/read/28475690/safety-effectiveness-and-haemodynamic-performance-of-a-new-stented-aortic-valve-bioprosthesis%C3%A2
#13
Robert J M Klautz, A Pieter Kappetein, Rüdiger Lange, Francois Dagenais, Louis Labrousse, Vinayak Bapat, Michael Moront, Martin Misfeld, Cathy Zeng, Joseph F Sabik Iii
OBJECTIVES: We assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™). METHODS: The PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. Death, valve-related adverse events (AEs), functional recovery and haemodynamic performance were assessed at discharge, 3-6 months and 1 year...
May 4, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/28471092/anatomical-risk-models-for-paravalvular-leak-and-landing-zone-complications-for-balloon-expandable-transcatheter-aortic-valve-replacement
#14
Jose F Condado, Frank E Corrigan, Stamatios Lerakis, Ioannis Parastatidis, Arthur E Stillman, Jose N Binongo, James Stewart, Kreton Mavromatis, Chandan Devireddy, Bradley Leshnower, Robert Guyton, Jessica Forcillo, Ateet Patel, Vinod H Thourani, Peter C Block, Vasilis Babaliaros
BACKGROUND: Though several anatomical characteristics have been reported separately as risk factors for paravalvular leak (PVL) and landing zone (LZ) complications after transcatheter aortic valve replacement (TAVR), multivariate risk models are needed. METHODS: Patients that underwent balloon-expandable TAVR with multidetector cardiac computed tomography (MDCT) sizing were studied. MDCT images were analyzed and the association between anatomical factors and ≥mild PVL, ≥moderate PVL, and LZ complications (annular rupture, requirement of new permanent pacemaker, and coronary obstruction) was determined, and subsequently competing predictive models were developed and validated...
May 4, 2017: Catheterization and Cardiovascular Interventions
https://www.readbyqxmd.com/read/28449479/early-results-of-the-sorin-%C3%A2-perceval-s-sutureless-valve-systematic-review-and-meta-analysis
#15
Karan Sian, Sheila Li, Daneish Selvakumar, Ross Mejia
BACKGROUND: Minimally invasive aortic valve replacement (MAVR) has demonstrated a benefit with respect to increased patient satisfaction due to minimised pain and earlier recovery. Sutureless valves may benefit MAVR and conventional aortic valve replacement (AVR) by reducing operative times and blood transfusion requirements. The Perceval valve (Sorin, Salluggia, Italy) is a self-expanding prosthesis made from bovine pericardium mounted in a nitinol stent, designed to simplify the implantation of an aortic valve...
March 2017: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28433509/transcutaneous-aortic-valve-implantation-using-the-carotid-artery-access-feasibility-and-clinical-outcomes
#16
Zacharenia Kallinikou, Alexandre Berger, Patrick Ruchat, Gregory Khatchatourov, Isabelle Fleisch, Branislav Korkodelovic, Emmanuel Henchoz, René-Andréas Marti, Stéphane Cook, Mario Togni, Jean-Jacques Goy
BACKGROUND: Transcarotid access is an alternative route for transcutaneous aortic valve implantation (TAVI) in patients with impossible transfemoral access. AIMS: We evaluated the safety, effectiveness and early and late clinical outcomes of CoreValve(®) implantation via the common carotid artery. METHODS: Eighteen patients (10 men, 8 women; mean age 84±5 years) at high surgical risk (mean EuroSCORE II 16±13%) with significant peripheral artery disease underwent TAVI via common carotid artery access under general anaesthesia...
April 19, 2017: Archives of Cardiovascular Diseases
https://www.readbyqxmd.com/read/28430909/clinical-trial-principles-and-endpoint-definitions-for-paravalvular-leaks-in-surgical-prosthesis-an-expert-statement
#17
Carlos E Ruiz, Rebecca T Hahn, Alain Berrebi, Jeffrey S Borer, Donald E Cutlip, Greg Fontana, Gino Gerosa, Reda Ibrahim, Vladimir Jelnin, Hasan Jilaihawi, E Marc Jolicoeur, Chad Kliger, Itzhak Kronzon, Jonathon Leipsic, Francesco Maisano, Xavier Millan, Patrick Nataf, Patrick T O'Gara, Philippe Pibarot, Stephen R Ramee, Charanjit S Rihal, Josep Rodes-Cabau, Paul Sorajja, Rakesh Suri, Julie A Swain, Zoltan G Turi, E Murat Tuzcu, Neil J Weissman, Jose L Zamorano, Patrick W Serruys, Martin B Leon
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices...
April 18, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28427582/clinical-trial-principles-and-endpoint-definitions-for-paravalvular-leaks-in-surgical-prosthesis-an-expert-statement
#18
REVIEW
Carlos E Ruiz, Rebecca T Hahn, Alain Berrebi, Jeffrey S Borer, Donald E Cutlip, Greg Fontana, Gino Gerosa, Reda Ibrahim, Vladimir Jelnin, Hasan Jilaihawi, E Marc Jolicoeur, Chad Kliger, Itzhak Kronzon, Jonathon Leipsic, Francesco Maisano, Xavier Millan, Patrick Nataf, Patrick T O'Gara, Philippe Pibarot, Stephen R Ramee, Charanjit S Rihal, Josep Rodes-Cabau, Paul Sorajja, Rakesh Suri, Julie A Swain, Zoltan G Turi, E Murat Tuzcu, Neil J Weissman, Jose L Zamorano, Patrick W Serruys, Martin B Leon
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices...
April 25, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28407126/mitral-valve-replacement-in-severely-calcified-mitral-valve-annulus-a-10-year-experience
#19
Kareem Salhiyyah, Hassan Kattach, Ahmed Ashoub, Diana Patrick, Szabolcs Miskolczi, Geoffrey Tsang, Sunil K Ohri, Clifford W Barlow, Theodore Velissaris, Steve Livesey
OBJECTIVES: Severe calcification in the mitral valve annulus is a challenging problem during mitral valve surgery. We describe our experience with mitral valve replacement in severely calcified mitral valve without decalcification of the annulus. METHODS: Between April 2001 and July 2011, 61 patients underwent mitral valve replacement with severe mitral annulus calcification without decalcification of the annulus. This retrospective study was performed to assess the surgical and the long-term postoperative outcomes in this group...
April 11, 2017: European Journal of Cardio-thoracic Surgery
https://www.readbyqxmd.com/read/28403562/feasibility-safety-and-efficacy-of-transcatheter-aortic-valve-replacement-without-balloon-predilation-a-systematic-review-and-meta-analysis
#20
Vincent Auffret, Ander Regueiro, Francisco Campelo-Parada, María Del Trigo, Olivier Chiche, Chekrallah Chamandi, Rishi Puri, Josep Rodés-Cabau
OBJECTIVES: To evaluate the feasibility, safety, and efficacy of direct transcatheter aortic valve replacement (TAVR), that is, TAVR without balloon predilation (BPD), by performing a systematic review and meta-analysis of available evidence. BACKGROUND: Avoiding BPD during TAVR was shown to be feasible in previous studies but the risks and benefits of this technique are unknown owing to the limited number of patients included in these studies. METHODS: We performed a systematic search for studies comparing direct TAVR vs TAVR performed with BPD...
April 12, 2017: Catheterization and Cardiovascular Interventions
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