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. 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: Theodor Fischlein, Thierry Folliguet, Bart Meuris, Malakh L Shrestha, Eric E Roselli, Anna McGlothlin, Utz Kappert, Steffen Pfeiffer, Pierre Corbi, Roberto Lorusso, Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement Investigators
• Journal: The Journal of thoracic and cardiovascular surgery (J Thorac Cardiovasc Surg) Vol. 161 Issue 3 Pg. 920-932 (03 2021) ISSN: 1097-685X [Electronic] United States
• PMID: 33478837 (Publication Type: Comparative Study, Equivalence Trial, Journal Article, Multicenter Study, Webcast)
• Copyright: Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Topics

• Aged
• Aged, 80 and over
• Aortic Valve (diagnostic imaging, physiopathology, surgery)
• Aortic Valve Stenosis (diagnostic imaging, mortality, physiopathology, surgery)
• Bioprosthesis
• Female
• Heart Valve Prosthesis
• Heart Valve Prosthesis Implantation (adverse effects, instrumentation, mortality)
• Humans
• Male
• Operative Time
• Postoperative Complications (mortality, therapy)
• Prospective Studies
• Prosthesis Design
• Reoperation
• Severity of Illness Index
• Sutureless Surgical Procedures (adverse effects, mortality)
• Time Factors
• Treatment Outcome