IMC Bovine Pericardial Valve: 11 Years

Publisher Website
Google Scholar
Abstract
From 1977 to 1988, 10,812 bovine pericardial valves were produced by IMC Biomédica and implanted. One thousand one hundred ninety-three were implanted by our group at IMC, including 666 exclusively in the mitral position. We are presenting our study of those mitral patients. Of the 663 patients, 586 were adults (over 21 years of age) and 77 were youngsters (under 21). Hospital mortality was 9.2%; 13.2% for the first 5.5 years (group I) and 6.3% for the second 5.5 years (group II). Eleven year follow-up was 98.8% complete and the mean time was 3.8 years. The actuarial survival was 74.3% ± 6.5% for the youngsters and 73.0% ± 3.7% for the adults. The fatal valve-related late complications (death from thromboembolism, calcification, and endocarditis) had an incidence of 1% per patient-year as follows: (1) endocarditis, 0.6% per patient-year; (2) calcification 0.1% per patient-year; and (3) cerebral vascular accident, 0.3% per patient year. The actuarial study revealed 95.0 % ± 1.0% freedom from fatal complications related to the prosthesis. The nonfatal valve-related late complications had an incidence of 2.9% per patient-year as follows: (1) endocarditis, 0.5% per patient-year; (2) calcification, 1.8% per patient-year; (3) cerebral vascular accident, 0.3% per patient-year; (4) periprosthetic leakage, 0.2% per patient-year; and (5) rupture, 0.1% per patient-year. The actuarial study revealed 55.2% ± 8.6% freedom from all complications including thromboembolism, endocarditis, calcification, periprosthetic leakage, and rupture. The actuarial study of the bioprosthesis revealed 95.8% ± 1.6% freedom from thromboembolism (linearized rate of 0.6% per patient-year); 99.1 % ± 0.6% freedom from rupture (linearized rate of 0.08% per patient-year); 90.1% ± 4.08% freedom from endocarditis in the young group (linearized rate of 1.5% per patient-year); and 95.2% ± 1.03% for adults (linearized rate of 1.0% per patient-year). Freedom from calcification was 43.1% ± 12.25% for the young group (linearized rate of 7.5% per patient-year) and 68.8% ± 9.3% for adults (linearized rate of 1.1% per patient-year) in the 11th year. We conclude that the IMC pericardial bioprosthesis performed well in a period of 11 years with low rates of fatal complication, ruptures, and thromboembolism without the use of anticoagulants. Calcification was the major complication mainly in youngsters.