CLINICAL-PERFORMANCE OF BIOLOGICAL AND MECHANICAL PROSTHESES

Prosthetic valve replacement remains the most viable alternative for the treatment of severely diseased heart valves. The cumulative experience of mechanical prostheses and bioprostheses was evaluated for a 10-year performance comparison: Carpentier-Edwards standard porcine bioprosthesis (CE-S), 1,214 operations; Carpentier-Edwards supraannular porcine bioprosthesis (CE-SAV), 2,489; and mechanical prostheses, 1,364 operations (St. Jude Medical, Carbomedics, Duromedics, and Bjork-Shiley Monostrut). The freedom from thromboembolism and hemorrhage at 10 years was 82% for CE-S, 78% for CE-SAV, and 65% for mechanical prostheses (p < 0.05). The relationship existed for major thromboembolism and hemorrhage, 91% (CE-S), 87% (CE-SAV), and 88% (mechanical) (p < 0.05), without clinical relevance. The freedom from structural valve deterioration and valve-related reoperation favored mechanical prostheses (p < 0.05) at 10 years (structural failure: 78% for CE-S, 81% for CE-SAV, and 99% for the mechanical group; reoperation: 74% for CE-S, 76% for CE-SAV, and 88% for mechanical prostheses). The freedom from fatal reoperation was not clinically different: 96% for CE-S, 99% for CE-SAV, and 99% for mechanical prostheses (p < 0.05) at 10 years. The freedom from valve-related mortality was not different (p = not significant) at 10 years: 87% for CE-S; 92% for CE-SAV; and 91% for mechanical. The freedom from permanent impairment or residual morbidity, primarily from thromboembolism, was 95% for CE-S, 92% for CE-SAV, and 95% for mechanical group (p < 0.05) but not clinically relevant. The freedom from overall valve-related complications favored both the bioprostheses groups over the mechanical group; 5-year rates were 86% for CE-S, 84% for CE-SAV, and 73% for mechanical (p < 0.05), the relationship extended to 9 years. There remains differentiating features between bioprostheses and mechanical prostheses at 10 years, but the serious complications of major thromboembolism and hemorrhage, fatal reoperation and valve-related mortality do not differentiate the prostheses types.