1. Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis
- Author
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Suzanne Kats, Andrea Blasio, Evaldas Girdauskas, Marco Solinas, Malakh Shrestha, Basel Ramlawi, Nikolaos Bonaros, Claudio Muneretto, Theodor Fischlein, Sidney Chocron, Manfredo Rambaldini, Anna McGlothlin, Douglas R. Johnston, Giovanni Troise, Denis Bouchard, Roberto Lorusso, Elisabet Berastegui, Daniel Bitran, Mahesh Ramchandani, Julio García-Puente, Utz Kappert, Jose Cuenca Castillo, Salvatore Tribastone, Sami Kueri, Martin Andreas, Gabriel Maluenda, Frédéric Pinaud, David Heimansohn, Dina De Bock, Filip Rega, Thorsten Hanke, Alberto Repossini, Steffen Pfeiffer, Elisa Mikus, Olivier Fabre, Bart Meuris, Laurent de Kerchove, Kevin Teoh, Eric E. Roselli, Erwin S.H. Tan, Shaohua Wang, André Vincentelli, Anno Diegeler, Pierre Voisine, Martin Grabenwoeger, Mattia Glauber, Peter Oberwalder, Thierry Folliguet, Matthias Siepe, Ehud Raanani, Pierre Corbi, Bernard Albat, CTC, MUMC+: MA Med Staf Spec CTC (9), RS: Carim - V04 Surgical intervention, MUMC+: MA Cardiothoracale Chirurgie (3), Hôpital Henri Mondor, Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), and Centre hospitalier universitaire de Poitiers (CHU Poitiers)
- Subjects
Aortic valve ,Male ,Time Factors ,[SDV]Life Sciences [q-bio] ,medicine.medical_treatment ,030204 cardiovascular system & hematology ,Severity of Illness Index ,MESH: Aged, 80 and over ,0302 clinical medicine ,Postoperative Complications ,Aortic valve replacement ,Valve replacement ,MESH: Postoperative Complications ,80 and over ,Myocardial infarction ,Prospective Studies ,Stroke ,MESH: Aortic Valve Stenosis ,MESH: Treatment Outcome ,MESH: Aged ,Aged, 80 and over ,Heart Valve Prosthesis Implantation ,Sutureless Surgical Procedures ,medicine.anatomical_structure ,Treatment Outcome ,Randomized controlled trial ,Aortic valve stenosis ,Aortic Valve ,Heart Valve Prosthesis ,Female ,MESH: Operative Time ,Cardiology and Cardiovascular Medicine ,MESH: Prosthesis Design ,MESH: Heart Valve Prosthesis Implantation ,Pulmonary and Respiratory Medicine ,Reoperation ,medicine.medical_specialty ,MESH: Heart Valve Prosthesis ,Operative Time ,Prosthesis Design ,MESH: Reoperation ,aortic valve replacement ,randomized controlled trial ,sutureless ,Aged ,Aortic Valve Stenosis ,Humans ,Bioprosthesis ,03 medical and health sciences ,MESH: Severity of Illness Index ,medicine ,MESH: Humans ,business.industry ,MESH: Sutureless Surgical Procedures ,MESH: Time Factors ,Extracorporeal circulation ,medicine.disease ,MESH: Prospective Studies ,MESH: Male ,Surgery ,MESH: Bioprosthesis ,030228 respiratory system ,Implant ,MESH: Aortic Valve ,business ,MESH: Female - Abstract
International audience; 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.
- Published
- 2020
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