INTERMEDIARY RESULTS WITH THE CARBOMEDICS BILEAFLET VALVULAR PROSTHESIS

From December 1988 to December 1995, 212 patients underwent valve repl acement with a CarboMedics bileaflet valve in our institution (103 aor tic valve replacements, 72 mitral valve replacements, and 37 double va lve replacements). Fifty-five percent were male patients. Mean age was 53.8+/-12.7 years. Forty seven percent of patients were in NYHA clini cal status III or IV. Operative mortality was 3,7% (8/212). All patien ts but eight were followed-up for an average of 2.9 years after their operation and total follow-up was 617 patient-years. At the time of th e study, more than 90% of patients were in NYHA class I or II, 26% wer e in atrial fibrillation and 100% of patients received anticoagulation treatment. There were 15 late deaths. After 7 years, the actuarial su rvival rate was 84+/-7%. Three patients died of valve-related causes. Valve-related complications included 5 thromboembolic episodes (0.8% p atient-year), 18 anticoagulant-related complications (2.9% patient-yea rs), 3 endocarditis (0.5% patient-year), and 4 reoperations (0.6% pati ent-year). After 7 years, freedom from thrombo-embolic complication wa s 97+/-2%, from anticoagulant-related complications was 88+/-6%, from endocarditis was 96+/-4%, and from reoperation was 95+/-5%. We conclud e that the 7-year results compare with other bileaflet valves. More fo llow-up and larger studies are mandated to give definite conclusions.