Long-term clinical experience with the Omnicarbon prosthetic valve.

Background: From February 1985 to December 1994, 781 Omnicarbon valve prostheses were implanted in 647 patients. These were 357 male and 290 female patients with a mean age of 53.5+/-10.5 years (range, 4 to 78 years). Before operation, 81% of the patients were in New York Heart Association class III or IV, 16% were in class II, and only 3% were in class I.
Methods: There were 227 aortic valve replacements (AVR) (35%), 286 mitral valve replacements (MVR) (44%), and 134 double-valve replacements (DVR) (21%) (AVR + MVR). Follow-up was 96.3% complete and consisted of 2,746 patient-years (mean follow-up, 4.6 years, and maximum follow-up, 10.7 years).
Results: Hospital mortality rates were 7.0% for AVR, 8.0% for MVR, and 8.2% for DVR. The annualized rate of anticoagulant-related hemorrhage was 0.8% per patient-year, and thromboembolism occurred at a rate of 0.7% per patient-year. No structural failure was observed during 10-year follow-up. Twenty-one instances of nonstructural dysfunction (two, pannus growth, and 19, dehiscence) of the Omnicarbon valve occurred in 20 patients, an incidence of 0.8% per patient-year. Hemolytic anemia was observed only in the presence of valvular dehiscence (6 of 19). Eight patients (0.3% per patient-year) had development of prosthetic valve endocarditis (4, AVR; 2, MVR; and 2 DVR). At the end of 10 years of follow-up, 91% of the survivors were in New York Heart Association class I or II. The overall survival rate at 10 years was 82.5%+/-2.6% (85.0%+/-3.9%, AVR; 81.0%+/-4.1%, MVR; and 82.5%+/-2.6%, DVR). Considering only valve-related deaths, the survival rate at 10 years was 91.9%+/-2.4% (90.0%+/-2.7%, AVR; 93.1%+/-3.8%, MVR; and 90.0%+/-1.8%, DVR).
Conclusions: Clinical results over a 10-year follow-up are excellent with the Omnicarbon prosthesis.