Clinical evaluation of new heart valve prostheses: update of objective performance criteria.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 25258160.
- Also identified by DOI 10.1016/j.athoracsur.2014.05.006.
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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).
Medical subject headings
- Heart Valve Diseases
- Heart Valve Prosthesis