From December 1988 to December 1995, 212 patients underwent valve replacement with a CarboMedics bileaflet valve in our institution (103 aortic valve replacements, 72 mitral valve replacements, and 37 double valve replacements). Fifty-five percent were male patients. Mean age was 53.8 +/- 12.7 years. Forty seven percent of patients were in NYHA clinical status III or IV. Operative mortality was 3.7% (8/212). All patients 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 the study, more than 90% of patients were in NYHA class I or II, 26% were in atrial fibrillation and 100% of patients received anticoagulation treatment. There were 15 late deaths. After 7 years, the actuarial survival rate was 84 +/- 7%. Three patients died of valve-related causes. Valve-related complications included 5 thromboembolic episodes (0.8% patient-year), 18 anticoagulant-related complications (2.9% patient-years), 3 endocarditis (0.5% patient-year), and 4 reoperations (0.6% patient-year). After 7 years, freedom from thrombo-embolic complication was 97 +/- 2%, from anticoagulant-related complications was 88 +/- 6%, from endocarditis was 96 +/- 4%, and from reoperation was 95 +/- 5%. We conclude that the 7-year results compare with other bileaflet valves. More follow-up and larger studies are mandated to give definite conclusions.