Seventy-six month experience with the Omniscience cardiac valve

Between August 1978 and September 1984, 440 patients were implanted with the Omniscience cardiac valve at three North American medical centers (210 aortic, AVR; 165 mitral, MVR; and 65 double valve replacements). Total follow-up was 1056 patient years; survivors were followed up to 76 months (mean 32), with 99% accountability. One hundred and eighty-six (42%) also underwent prior or concomitant major cardiac surgical procedures. Mean age was 56 +/- 12 years. Preoperatively, 3% were in New York Heart Association (NYHA) Class I, 18% II, 54% III, 26% IV. The 5 1/2 year actuarial survival rate for death from valve-related causes (thromboembolism, valve thrombosis, perivalvular leak) was 97% overall. The 5 1/2 year actuarial survival rate from all death causes was 78%. The complication rates, expressed as %/patient-year (endocarditis 0.7; anticoagulant-related hemorrhage 1.0; perivalvular leak 1.5; pannus/tissue overgrowth 0.6; and transient ischemic episode 1.2) demonstrate that advanced age at implant and additional major cardiac surgical procedures do not affect occurrence. Actuarial freedom from thrombotic complications (thromboembolism with residual deficit and valve thrombosis) at 5 1/2 years was 95% overall. Postoperatively, of 348 patients with known NYHA, 65% were in NYHA I, 28% II, 5% III, and 2% IV.