Glutaraldehyde-preserved porcine bioprosthesis. Factors affecting performance as determined by pathologic studies.

The causes of porcine valve failure were evaluated pathologically in 129 bioprostheses (BP) removed at surgery or necropsy. Fifty-one BP had been in place for less than two months (early explants); most of the complications of this group were observed in the mitral position: left ventricular outflow obstruction (43 percent), thrombosis (23.5 percent), myocardial dysruption (20 percent), cardiac rupture (10 percent), and perivalvular leak (3.5 percent). Among the 78 explants in place for more than two months (late explants), 66 had evidence of dysfunction. Calcification was the leading cause of failure (46 percent), followed by thrombosis (17 percent), endocarditis (12 percent), fibrous tissue overgrowth (10 percent), perivalvular leak (9 percent), and primary cusp tears (6 percent). Calcific degeneration is a hallmark of the phenomenon of biodegradation, and experimental animal models are encouraged since they may represent the clue to preventing calcification and therefore enhancing performance and durability of the porcine BP.