Roberto Lorusso1, Thierry Folliguet2, Malakh Shrestha3, Bart Meuris4, Arie Pieter Kappetein5, Eric Roselli6, Catherine Klersy7, Michele Nozza8, Luc Verhees8, Cristina Larracas8, Giovanni Goisis8, Theodor Fischlein9. 1. Department of Cardio-Thoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC + ), Maastricht, The Netherlands. 2. Chirurgie Cardiaque & Transplantation, Assistance Publique, Hôpital, Henri Mondor, Université Paris 12 UPEC, France. 3. Department of Thoracic and Cardiovascular Surgery, Hannover Medical School, Hannover, Germany. 4. Cardiac Surgery Department, Universitaire Ziekenhuizen Leuven, Leuven, Belgium. 5. Thoraxcenter, Erasmus Medical Centre, Rotterdam, The Netherlands. 6. Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio, United States. 7. Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardia, Italy. 8. LivaNova Plc, London, United Kingdom. 9. Department of Cardiac Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.
Abstract
INTRODUCTION:Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. MATERIALS AND METHODS: PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. DISCUSSION: PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years. Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities:
INTRODUCTION: Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. MATERIALS AND METHODS: PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. DISCUSSION: PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years. Georg Thieme Verlag KG Stuttgart · New York.
Authors: Michael L Williams; Campbell D Flynn; Andrew A Mamo; David H Tian; Utz Kappert; Manuel Wilbring; Thierry Folliguet; Antonio Fiore; Antonio Miceli; Augusto D'Onofrio; Giorgia Cibin; Gino Gerosa; Mattia Glauber; Theodor Fischlein; Francesco Pollari Journal: Ann Cardiothorac Surg Date: 2020-07
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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