One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis

The Journal of Thoracic and Cardiovascular Surgery

Federico M. Asch¹  Francois Dagenais²  Louis Labrousse³  A. Pieter Kappetein⁴  Cathy Zeng⁵  Michael Moront⁶  Vinayak Bapat⁷  Michael J. Reardon⁸  Himanshu J. Patel⁹  Joseph F. Sabik^1,10  Rüdiger Lange^1,11  Neil J. Weissman^1,12  Vivek Rao^1,13 

[1] Biostatistics Department, Medtronic, Minneapolis, Minn;Cardiac Surgery, Québec Heart and Lung Institute, Québec City, Québec, Canada;Cardiac and Vascular Surgery, University Hospital of Bordeaux, Bordeaux, France;CardioThoracic Surgery, Erasmus Medical Center, Rotterdam, The Netherlands;Cardiothoracic Surgery, Leiden University Medical Center, Leiden, The Netherlands;Cardiothoracic Surgery, ProMedica Toledo Hospital, Toledo, Ohio;Cardiothoracic Surgery, St Thomas' Hospital, London, United Kingdom;Cardiovascular Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Tex;Department of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Mich;Department of Surgery, University Hospitals, Case Western Reserve University School of Medicine, Cleveland, Ohio;German Heart Center, Technical University of Munich, Munich, Germany;MedStar Health Research Institute, Washington, DC;Toronto General Hospital, Toronto, Ontario, Canada

关键词: aortic regurgitation;    aortic stenosis;    bovine pericardial bioprosthesis;    surgical aortic valve replacement;   

DOI  :  10.1016/j.jtcvs.2018.03.171

学科分类：心脏病和心血管学

来源: Mosby, Inc.

【 摘 要 】

ObjectivesThe study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve.MethodsThis trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration–specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis.ResultsThe primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P P ConclusionsThis analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.

【 授权许可】

Unknown