THE CARBOMEDICS VALVE - MIDTERM FOLLOW-UP WITH ANALYSIS OF RISK-FACTORS

Background. This study examined the midterm results with the CarboMedi cs prosthetic valve. Methods. From 1987 through 1991 a total of 569 pa tients received the CarboMedics prosthesis. Results. Early mortality w as 4.9% and related to emergency operation, presence of diabetes melli tus, coronary artery disease, preoperative New York Heart Association class, duration of cardiopulmonary bypass, and aortic cross-clamp time . Midterm follow-up with respect to mortality was 100% complete. All p atients were followed up in the hospital after 1 year. In addition 86% of the patients responded to a questionnaire. Mean follow-up was 3 ye ars (range, 0 to 5.6 years). Cumulative survival at 1 and 4 years was 91.2% +/- 1.2% and 83.7% +/- 1.8%, respectively. Five patients experie nced obstructive valve thrombosis (0.3%/patient-year), 16 patients had major thromboembolic events (0.9%/patient-year), and 10 patients had major warfarin-related bleeding (0.6%/patient-year) requiring hospital ization or blood transfusions. Eight patients were reoperated on for p araprosthetic leak (0.4%/patient-year). Prosthetic valve endocarditis developed in 4 patients (0.2%/patient-year). No structural valve failu re was observed. Conclusions. Midterm follow-up demonstrates that the CarboMedics mechanical prosthesis is reliable and has an acceptable ra te of valve-related complications.