Durability of pericardial versus porcine bioprosthetic heart valves

Abstract

To compare the probability, and modes, of explantation for Carpentier-Edwards pericardial versus porcine valves. Our porcine series began in 1974 and our pericardial series in 1991, with annual prospective follow-up. We used the Kaplan-Meier method and Cox regression for estimation and analysis of patient mortality, and the cumulative incidence function and competing risks regression for estimation and analysis of valve durability. Through the end of 2010, we had implanted 506 porcine and 2449 pericardial aortic valves and 181 porcine and 163 pericardial mitral valves. The corresponding total and maximum follow-up years were 3471 and 24, 11,517 and 18, 864 and 22, and 645 and 9. The corresponding probabilities (cumulative incidence function) of any valve explant were 7%, 8%, 22%, and 8%, and of explant for structural valve deterioration were 4%, 5%, 16%, and 5% at 15 years for the first 3 series and at 8 years for the fourth (pericardial mitral valve) series. Using competing risks regression for structural valve deterioration explant, with age, gender, valve size, and concomitant coronary bypass surgery as covariates, a slight (subhazard ratio, 0.79), but nonsignificant, protective effect was found for the pericardial valve in the aortic position and a greater (subhazard ratio, 0.31) and almost significant (P=.08) protective effect of the pericardial valve in the mitral position. Leaflet tear was responsible for 61% of the structural valve deterioration explants in the porcine series and 46% in the pericardial series. Using competing risks regression, the pericardial valve had a subhazard ratio for structural valve deterioration explant of less than 1 in both positions, approaching statistical significance in the mitral position. The mode of structural valve deterioration was predominantly leaflet tear for porcine valves and fibrosis/calcification for pericardial valves.