Background. From February 1985 to December 1994, 781 Omnicarbon valve prost
heses were implanted in 647 patients. These were 357 male and 290 female pa
tients with a mean age of 53.5 +/- 10.5 years (range, 4 to 78 years). Befor
e operation, 81% of the patients were in New York Heart Association class I
II 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 v
alve replacements (IC IVR) (44%), and 134 double-valve replacements (DVR) (
21%) (AVR + MVR). Follow-up was 96.3% complete and consisted of 2,746 patie
nt-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 patien
t-year. No structural failure was observed during 10-year follow-up. Twenty
-one instances of nonstructural dysfunction (two, pannus growth, and 19, de
hiscence) of the Omnicarbon valve occurred in 20 patients, an incidence of
0.8% per patient-year. Hemolytic anemia was observed only in the presence o
f 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 yea
rs 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 t
he Omnicarbon prosthesis. (Ann Thorac Surg 1999;68:881-6) (C) 1999 by The S
ociety of Thoracic Surgeons.