Retrieval analysis of mechanical heart valves: impact on design and clinical practice.
Explanted mechanical heart valves were examined nondestructively, and the findings were related to guidelines, technical reports, and other information to judge the risk of failure and its possible impact on valve design and clinical practice. Diagnoses for single valves could be made, but risks and rates of failure for patient populations could not be predicted due to insufficient information concerning the manufacturing process and valve and patient numbers. Based on the results of this study and the principle that decisions on recalls and patient counseling must be based on scientific knowledge rather than on wait and see policies, the following is recommended: registration of all implanted valves, follow-up of a large cohort of valve carriers, comparison of wear test results of preimplant and postretrieval valves, maintenance of a reference stock of valves and materials, and submission of failure scenarios to certifying bodies.
Cromheecke
M E
ME
Department of Cardiopulmonary Surgery, Academic Medical Center, University of Amsterdam, The Netherlands.
Overkamp
P J
PJ
de Mol
B A
BA
van Gaalen
G L
GL
Becker
A E
AE
D017408:Guidelines as Topic; D006350:Heart Valve Prosthesis / Q000592:standards*; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008137:Longitudinal Studies; D009426:Netherlands; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012042:Registries; D012086:Reoperation; D012307:Risk Factors