Theodor Fischlein1, Thierry Folliguet2, Bart Meuris3, Malakh L Shrestha4, Eric E Roselli5, Anna McGlothlin6, Utz Kappert7, Steffen Pfeiffer8, Pierre Corbi9, Roberto Lorusso10. 1. Klinikum Nürnberg, Cardiovascular Center, Paracelsus Medical University, Nuremberg, Germany. Electronic address: theodor.fischlein@klinikum-nuernberg.de. 2. Department of Cardiac Surgery, Hôpital Henri Mondor, Université Paris 12, Créteil, Paris, France. 3. UZ Gasthuisberg Leuven, University Hospital, Leuven, Belgium. 4. Hannover Medical School, Hannover, Germany. 5. Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. 6. Berry Consultants, LCC, Austin, Tex. 7. Herzzentrum Dresden GmbH Universitätsklinik, Dresden, Germany. 8. Klinikum Nürnberg, Cardiovascular Center, Paracelsus Medical University, Nuremberg, Germany; Schön Klinik Vogtareuth, Vogtareuth, Germany. 9. Poitiers University Hospital, Poitiers, France. 10. Cardio-Thoracic Surgery Department, Heart and Vascular Center, Maastricht University Medical Center (MUMC+), Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.
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) orconventional stented (n = 457) valves; meanages 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.
RCT Entities:
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: Jurij M Kalisnik; Giuseppe Santarpino; Andrea I Balbierer; Janez Zibert; Ferdinand A Vogt; Matthias Fittkau; Theodor Fischlein Journal: J Clin Med Date: 2022-06-14 Impact factor: 4.964
Authors: Theodor Fischlein; Elena Caporali; Federico M Asch; Ferdinand Vogt; Francesco Pollari; Thierry Folliguet; Utz Kappert; Bart Meuris; Malakh L Shrestha; Eric E Roselli; Nikolaos Bonaros; Olivier Fabre; Pierre Corbi; Giovanni Troise; Martin Andreas; Frederic Pinaud; Steffen Pfeiffer; Sami Kueri; Erwin Tan; Pierre Voisine; Evaldas Girdauskas; Filip Rega; Julio García-Puente; Laurent De Kerchove; Roberto Lorusso Journal: Front Cardiovasc Med Date: 2022-02-18