TY - JOUR
T1 - Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis
AU - Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement Investigators
AU - Fischlein, Theodor
AU - Folliguet, Thierry
AU - Meuris, Bart
AU - Shrestha, Malakh L.
AU - Roselli, Eric E.
AU - McGlothlin, Anna
AU - Kappert, Utz
AU - Pfeiffer, Steffen
AU - Corbi, Pierre
AU - Lorusso, Roberto
AU - Fabre, Olivier
AU - Pinaud, Frederic
AU - Troise, Giovanni
AU - Kueri, Sami
AU - Siepe, Matthias
AU - Bonaros, Nikolaos
AU - Tan, Erwin
AU - Andreas, Martin
AU - García-Puente, Julio
AU - Voisine, Pierre
AU - Rega, Filip
AU - Girdauskas, Evaldas
AU - Berastegui, Elisabet
AU - Hanke, Thorsten
AU - Kats, Suzanne
AU - Blasio, Andrea
AU - Muneretto, Claudio
AU - Repossini, Alberto
AU - Tribastone, Salvatore
AU - De Kerchove, Laurent
AU - Mikus, Elisa
AU - Solinas, Marco
AU - Rambaldini, Manfredo
AU - Chocron, Sidney
AU - De Bock, Dina
AU - Wang, Shaohua
AU - Grabenwoeger, Martin
AU - Raanani, Ehud
AU - Glauber, Mattia
AU - Maluenda, Gabriel
AU - Ramlawi, Basel
AU - Bouchard, Denis
AU - Johnston, Douglas
AU - Diegeler, Anno
AU - Bitran, Daniel
AU - Teoh, Kevin
AU - Vincentelli, André
AU - Castillo, José Cuenca
AU - Albat, Bernard
AU - Oberwalder, Peter
N1 - Publisher Copyright:
© 2020 The American Association for Thoracic Surgery
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
KW - aortic valve replacement
KW - randomized controlled trial
KW - sutureless
UR - http://www.scopus.com/inward/record.url?scp=85099629529&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85099629529&partnerID=8YFLogxK
U2 - 10.1016/j.jtcvs.2020.11.162
DO - 10.1016/j.jtcvs.2020.11.162
M3 - Article
C2 - 33478837
AN - SCOPUS:85099629529
SN - 0022-5223
VL - 161
SP - 920
EP - 932
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 3
ER -