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.
|Number of pages||12|
|Journal||Journal of Thoracic and Cardiovascular Surgery|
|Publication status||Published - Mar 2021|
|Event||100th 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 2020 → 23 May 2020
Conference number: 100
- aortic valve replacement
- randomized controlled trial