| Fatigue
Analysis of Clinical Bioprosthetic Heart Valves Manufactured using Photooxidized Bovine
Pericardium Maya Butterfield PhD, John Fisher D Eng Recent reports have shown early clinical failures of bioprosthetic heart valves manufactured using dye-mediated photooxidized bovine pericardium. The failures were attributed to abrasion of the inflow surface of the leaflets against the cloth-covered inner face of the outer valve frame, but had not been detected during preclinical testing of such valves. The purpose of this study was to determine if such failure modes could be replicated during fatigue testing of the photooxidized valves, and whether lining of the inflow face of the outer frame with pericardium could eliminate these failures. The fatigue properties of six lined and six PhotoFixR a valves were determined using Rowan Ash fatigue accelerators. This method had been used previously successfully to simulate early clinical failures in glutaraldehyde-treated pericardial bioprosthetic heart valves. After 200 million cycles, no fatigue failures of either the lined or the unlined PhotoFix a valves had occurred. Moreover, the leaflet tears that had been observed clinically were not replicated in this study. The accelerated fatigue tester did not provide an adequate model for the prediction of clinical failure for the photooxidized pericardial valves. |
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