title: Clinical evaluation of new heart valve prostheses: update of objective performance criteria.
abstract: This article summarizes the long-term clinical results of the Food and Drug Administration-approved heart valves, provides current updates to the objective performance criteria (OPC) used to evaluate new heart valve prostheses, and documents the steps that the International Organization for Standardization Committee used to arrive at the updated OPC. Data were extracted from 19 Food and Drug Administration summaries of safety and effectiveness data reports (31 series) and 56 literature articles (85 series) published from 1999 to 2012. The OPC were calculated for five valve-related complications by valve type (mechanical and bioprosthetic) and valve position (aortic and mitral).
authors.affiliation: Medical Data Research Center, Providence Health and Services, Portland, Oregon. Electronic address: yingxing.wu@providence.org.
authors.forename: YingXing
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Department of Cardiothoracic Surgery, University Hospital of Wales, Heath Park, Cardiff, United Kingdom.
authors.forename: Eric G
authors.initials: EG
authors.lastname: Butchart
authors.affiliation: Division of Cardiovascular Medicine and the Howard Gilman Institute for Heart Valve Diseases, State University of New York Downstate Medical Center, Brooklyn, New York.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Borer
authors.affiliation: School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, Georgia.
authors.forename: Ajit
authors.initials: A
authors.lastname: Yoganathan
authors.affiliation: Medical Data Research Center, Providence Health and Services, Portland, Oregon.
authors.forename: Gary L
authors.initials: GL
authors.lastname: Grunkemeier
mesh_terms: D006349:Heart Valve Diseases / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006801:Humans; D011474:Prosthesis Design; D014481:United States; D014486:United States Food and Drug Administration