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, Olivier Fabre, Frederic Pinaud, Giovanni Troise, Sami Kueri, Matthias Siepe, Nikolaos Bonaros, Erwin Tan, Martin Andreas, Julio Garcia-Puente, Pierre VoisineFilip 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, Andre Vincentelli, Jose Cuenca Castillo, Bernard Albat, Peter Oberwalder, Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement Investigators

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

31 Citations (Web of Science)

Abstract

bjective: 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

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.

Original languageEnglish
Pages (from-to)920-931
Number of pages12
JournalJournal of Thoracic and Cardiovascular Surgery
Volume161
Issue number3
DOIs
Publication statusPublished - Mar 2021
Event100th Annual Meeting of the American Association for Thoracic Surgery: A Virtual Learning Experience - Online, American Association for Thoracic Surgery, Beverly, United States
Duration: 22 May 202023 May 2020
Conference number: 100
https://www.aats.org/aatsimis/AATSEvent/Home2.aspx

Keywords

  • aortic valve replacement
  • randomized controlled trial
  • sutureless

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