[Clinical experience with the omnicarbon valve prosthesis].

Between January 1985 and March 1990, isolated valve replacements with the Omnicarbon valve were performed in 90 patients aged 34-72 years. There were 53 aortic valve replacements (AVR) and 37 mitral valve replacements (MVR). The cumulative follow-up was 320 patient-year (py) with a mean follow-up of 3.7 +/- 1.4 years. There were 3 operative and hospital mortalities (3.3%), resulting from retrograde aortic dissection during cardiopulmonary bypass, postoperative renal failure, and rupture of infective pseudoaneurysm in ascending aorta. Seven patients died during the late postoperative period, 4 due to valve-related causes. Two of these patients died of prosthetic valve endocarditis (PVE), while the others died of thromboembolism (including valve thrombosis). The overall actuarial survival rate at 6 years was 86.3% (98.8% for AVR, and 82.1% for MVR). There were 2 thromboembolic events (one mesenteric artery thrombosis, and the other valve thrombosis). The linearized incidence of thromboembolism was 0.63%/py. PVE occurred in 3 patients (0.94%/py). One patient (0.31%/py) was found to have a valve dehiscence due to aortitis syndrome. There were no instances of anticoagulant-related hemorrhage, or valve-related hemolysis. The actuarial rate of freedom from valve-related mortality at 6 years was 93.5% (100% for AVR, and 88.1% for MVR). On the basis of a follow-up period of 6 years, good clinical results and a low incidence of valve-related complications can be demonstrated with Omnicarbon valve.