Background: There are few reports on the long-term results of Carbomedics prosthetic heart valves.
Methods: Five hundred five patients who underwent valve replacement with this prosthesis in the aortic or mitral position were chosen for this study. Patients' mean age was 57 years. There were 173 aortic (AVR), 253 mitral (MVR), and 79 double (DVR) valve implants. The mean follow-up was 5.1 years, and cumulative follow-up was 2,590 patient-years with an overall follow-up rate of 99.2%.
Results: The early mortality rate for the total population was 2.8% (AVR 1.2%, MVR 3.6%, DVR 3.8%). Actuarial freedom from thromboembolism at 10 years was 81.8% +/- 5.1%, 85.7% +/- 3.2%, and 88.8% +/- 6.8% for AVR, MVR, and DVR, respectively. At 10 years, 92.7% of AVR, 85.4% of MVR, and 94.7% of DVR patients were free of valve-related death. Overall survival rate at 10 years was 77.6% +/- 4.6%, 71.8% +/- 4.2%, and 81.3% +/- 5.8% for AVR, MVR, and DVR, respectively. The linearized rate of thromboembolism was 1.45%/patient-year, 1.78%/patient-year, 0.67%/patient-year; of major bleeding events, 0.52%/patient-year, 0.85%/patient-year, 0.45%/patient-year; of valve thrombosis, 0%/patient-year, 0.25%/patient-year, 0%/patient-year; of prosthetic valve endocarditis, 0.1%/patient-year, 0.25%/patient-year, 0.22%/patient-year; and of all reoperations, 0.31%/patient-year, 0.93%/patient-year, 1.1%/patient-year for AVR, MVR, and DVR, respectively.
Conclusions: The Carbomedics prosthetic heart valves showed comparable or even better results than those of other mechanical valves with respect to morbidity and mortality. These results may justify the use of Carbomedics valves as one of the mechanical heart valves.