Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis
Theodor Fischlein, Thierry Folliguet, Bart Meuris, Malakh L Shrestha, Eric E Roselli, Anna McGlothlin, Utz Kappert, Steffen Pfeiffer, Pierre Corbi, Roberto Lorusso, Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement Investigators, Olivier Fabre, Frederic Pinaud, Giovanni Troise, Sami Kueri, Matthias Siepe, Nikolaos Bonaros, Erwin Tan, Martin Andreas, Julio García-Puente, Pierre Voisine, Filip Rega, Evaldas Girdauskas, Elisabet Berastegui, Thorsten Hanke, Suzanne Kats, Andrea Blasio, Claudio Muneretto, Alberto Repossini, Salvatore Tribastone, Laurent De Kerchove, Elisa Mikus, Marco Solinas, Manfredo Rambaldini, Sidney Chocron, Dina De Bock, Shaohua Wang, Martin Grabenwoeger, Ehud Raanani, Mattia Glauber, Gabriel Maluenda, Basel Ramlawi, Denis Bouchard, Douglas Johnston, Anno Diegeler, Daniel Bitran, Kevin Teoh, André Vincentelli, José Cuenca Castillo, Bernard Albat, Peter Oberwalder, Mahesh Ramchandani, David Heimansohn, Theodor Fischlein, Thierry Folliguet, Bart Meuris, Malakh L Shrestha, Eric E Roselli, Anna McGlothlin, Utz Kappert, Steffen Pfeiffer, Pierre Corbi, Roberto Lorusso, Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement Investigators, Olivier Fabre, Frederic Pinaud, Giovanni Troise, Sami Kueri, Matthias Siepe, Nikolaos Bonaros, Erwin Tan, Martin Andreas, Julio García-Puente, Pierre Voisine, Filip Rega, Evaldas Girdauskas, Elisabet Berastegui, Thorsten Hanke, Suzanne Kats, Andrea Blasio, Claudio Muneretto, Alberto Repossini, Salvatore Tribastone, Laurent De Kerchove, Elisa Mikus, Marco Solinas, Manfredo Rambaldini, Sidney Chocron, Dina De Bock, Shaohua Wang, Martin Grabenwoeger, Ehud Raanani, Mattia Glauber, Gabriel Maluenda, Basel Ramlawi, Denis Bouchard, Douglas Johnston, Anno Diegeler, Daniel Bitran, Kevin Teoh, André Vincentelli, José Cuenca Castillo, Bernard Albat, Peter Oberwalder, Mahesh Ramchandani, David Heimansohn
Abstract
Objective: Sutureless aortic valves are a novel option for aortic valve replacement. We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis.
Methods: The Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016 to September 2018) to aortic valve replacement with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (composite of all-cause death, myocardial infarction, stroke, or valve reintervention) at 1 year.
Results: At 47 centers (12 countries), 910 patients were randomized to sutureless (n = 453) or conventional stented (n = 457) valves; mean ages were 75.4 ± 5.6 and 75.0 ± 6.1 years, and 50.1% and 44.9% were female, respectively. Mean ± standard deviation Society of Thoracic Surgeons scores were 2.4 ± 1.7 and 2.1 ± 1.3, and a ministernotomy approach was used in 50.4% and 47.3%, respectively. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for major adverse cerebral and cardiovascular events at 1 year, whereas aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0 ± 34.1 minutes vs 87.8 ± 33.9 minutes; mean crossclamp times: 48.5 ± 24.7 vs 65.2 ± 23.6; both P < .0001), but resulted in a higher rate of pacemaker implantation (11.1% vs 3.6% at 1 year). Incidences of perivalvular and central leak were similar.
Conclusions: Sutureless valves were noninferior to stented valves with respect to major adverse cerebral and cardiovascular events at 1 year in patients undergoing aortic valve replacement (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.
Keywords: aortic valve replacement; randomized controlled trial; sutureless.
Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
Source: PubMed