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Retrieval Analysis of Mechanical Heart Valves: Impact on Design and Clinical Practice
Author(s) -
Cromheecke Ma E.,
Overkamp Peter J.B.,
De Mol Bas A.J.M.,
Van Gaalen Geerda L.,
Becker Anton E.
Publication year - 1998
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1046/j.1525-1594.1998.06172.x
Subject(s) - cardiac valve , mechanical heart , medicine , heart valve , process (computing) , risk analysis (engineering) , operations management , medical emergency , engineering , computer science , surgery , operating system
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.