New morphologic aspects of explanted Hancock Extracorporeal pericardial bioprostheses.

Between 1981 and 1987 a total of 479 Hancock Extracorporeal bovine pericardial bioprostheses were implanted in 458 patients. During the time period from 1990 to 1993, 21 valves, 15 in the aortic and six in the mitral position, had to be removed 72 to 109 months after implantation. The mean age of these patients at the time of implantation was 49.7 +/- 10.5 years. All 21 removed as well as one unimplanted bioprosthesis were morphologically investigated. Visual examination, radiography, histology and ultrastructural observations were performed using scanning and transmission electron microscopy. In addition, clinical data were correlated to morphological findings. All valves failed due to cusp tears originating at the stent posts. Calcification was minimal in five valves, moderate in 10, and severe in five valves. Only one valve showed no mineralization at all. The late morphologic changes were associated with thickening of valve leaflets, tissue delamination, calcification, degeneration of collageneous network, and extensive insudation of plasma proteins and lipids. The present findings suggest that denatured collagen molecules may be capable of inducing immune response.