Sutureless Versus Conventional Bioprostheses for Aortic Valve Replacement in Severe Symptomatic Aortic Valve Stenosis

ABSTRACT Objective Sutureless aortic valves are a novel option for aortic valve replacement (AVR). We sought to demonstrate noninferiority of sutureless versus standard bioprostheses in severe symptomatic aortic stenosis. Methods PERSIST-AVR is a prospective, randomized, adaptive, open-label trial. Patients were randomized (March 2016–September 2018) to AVR with a sutureless or stented valve using conventional or minimally invasive approach. Primary outcome was freedom from major adverse cerebral and cardiovascular events (MACCE; 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, respectively, and 50.1% and 44.9% were female. Mean±SD Society of Thoracic Surgeons scores were 2.4±1.7 and 2.1±1.3, respectively, and a ministernotomy approach was used in 50.4% and 47.3%. Concomitant procedures were performed with similar rates in both groups. Noninferiority was demonstrated for MACCE at 1 year, while aortic valve hemodynamics improved equally in both groups. Use of sutureless valves significantly reduced surgical times (mean extracorporeal circulation times: 71.0±34.1 vs 87.8±33.9 min; mean cross-clamp times: 48.5±24.7 vs 65.2±23.6; both p Conclusions Sutureless valve was noninferior to stented valves with respect to MACCE at 1 year in patients undergoing AVR (alone or with coronary artery bypass grafting). This suggests that sutureless valves should be considered as part of a comprehensive valve program.