Clinical evaluation of new heart valve prostheses: update of objective performance criteria

Ann Thorac Surg. 2014 Nov;98(5):1865-74. doi: 10.1016/j.athoracsur.2014.05.006. Epub 2014 Sep 23.

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).

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Heart Valve Diseases / surgery*
  • Heart Valve Prosthesis*
  • Humans
  • Prosthesis Design
  • United States
  • United States Food and Drug Administration