Durability of pericardial versus porcine bioprosthetic heart valves

Objectives: To compare the probability, and modes, of explantation for Carpentier-Edwards pericardial versus porcine valves. Methods: 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. Results: 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. Conclusions: 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.