The Omnicarbon tilting-disc heart valve prosthesis. A clinical and Doppler echocardiographic follow-up

From 1986 to 1990, 172 patients with a median age of 60.5 years (range 20 to 79 years) received 187 Omnicarbon valves (109 aortic valve replacements, 48 mitral valve replacements, and 15 double valve replacements). Patients were followed-up for a median observation period of 2.5 years (range 4 months to 5.2 years) by clinical and Doppler echocardiographic examination. Follow-up was complete in 98%. Operative mortality (death within 30 days) was 1.7%, and linearized late mortality was 2.6% per patient-year, corresponding to an actuarial survival rate for operative survivors of 89% after 4 years. The overall 4-year postoperative survival was 87% (93% for aortic valve replacement, 77% for mitral valve replacement). Compared with age- and sex-adjusted Swiss death rates, there was an excess mortality of 5% after 4 years. Percentages for freedom from valve-related complications at 4 years are as follows: thromboembolism, 98% (aortic valve replacement, 98%, and mitral valve replacement, 96%); anticoagulant-related hemorrhage, 95%; valve endocarditis, 96%; reoperation, 96%; and permanent valve-related impairment, 99%. The overall 4-year event-free survival was 76% (80% for aortic valve replacement and 69% for mitral valve replacement). New York Heart Association class improved in 88% of the patients by 1 to 3 grades, and only 3% remained in class III after operation. For the most commonly used aortic valve (23 mm), Doppler echocardiography revealed a peak pressure gradient of 29 +/- 10 mm Hg, a fractional shortening/peak pressure gradient ratio of 1.34 +/- 0.61, and a performance index of 0.35 +/- 0.08. In the most commonly used mitral valve (27 mm), the mean pressure gradient was 4.0 +/- 2.1 mm Hg. We conclude that excellent clinical and hemodynamic results can be obtained with the Omnicarbon prosthesis, in both the aortic and mitral positions.