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.