Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis Conferences uri icon

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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.

authors

  • Fischlein, Theodor
  • Folliguet, Thierry
  • Meuris, Bart
  • Shrestha, Malakh L
  • Roselli, Eric E
  • McGlothlin, Anna
  • Kappert, Utz
  • Pfeiffer, Steffen
  • Corbi, Pierre
  • Lorusso, Roberto
  • Fabre, Olivier
  • Pinaud, Frederic
  • Troise, Giovanni
  • Kueri, Sami
  • Siepe, Matthias
  • Bonaros, Nikolaos
  • Tan, Erwin
  • Andreas, Martin
  • García-Puente, Julio
  • Voisine, Pierre
  • Rega, Filip
  • Girdauskas, Evaldas
  • Berastegui, Elisabet
  • Hanke, Thorsten
  • Kats, Suzanne
  • Blasio, Andrea
  • Muneretto, Claudio
  • Repossini, Alberto
  • Tribastone, Salvatore
  • De Kerchove, Laurent
  • Mikus, Elisa
  • Solinas, Marco
  • Rambaldini, Manfredo
  • Chocron, Sidney
  • De Bock, Dina
  • Wang, Shaohua
  • Grabenwoeger, Martin
  • Raanani, Ehud
  • Glauber, Mattia
  • Maluenda, Gabriel
  • Ramlawi, Basel
  • Bouchard, Denis
  • Johnston, Douglas
  • Diegeler, Anno
  • Bitran, Daniel
  • Teoh, Kevin
  • Vincentelli, André
  • Castillo, José Cuenca
  • Albat, Bernard
  • Oberwalder, Peter
  • Ramchandani, Mahesh
  • Heimansohn, David

publication date

  • March 2021

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