Up to eight years' follow-up of 997 patients receiving the CarboMedics prosthetic heart valve

Background. The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis. Methods. Nine hundred ninety-seven consecutive patients underwent mechanical valve implantation (aortic, 771; mitral, 169; double, 52; tricuspid, 5) with this prosthesis from September 1987 through December 1993. The mean age was 62.3 +/- 13.7 years (range, 0.4 to 84 years); 56.6% (564 patients) were men. Four hundred seventy patients (47.1%) underwent additional surgical procedures. Mean follow-up was 4.1 +/- 2.2 years (range, 0 to 8.3 years) with a total of 4,040 patient-years. Results. Early mortality was 5.0% (50/997; aortic, 4.4%; mitral, 6.4%; double, 9.6%). Late mortality was 14.8% (140/947). Survival at 7 years was 75.9% +/- 1.8% (aortic, 78.4% +/- 2%; mitral, 70.7% +/- 4.5%; double, 60.8% +/- 7.4%). When matched for sex and age and compared with the normal Norwegian population, our patients had an increased standard mortality ratio in both men (1.9 +/- 0.4) and women (2.9 +/- 0.6). The linearized rate of major thromboembolism was 0.9% per patient-year, valve thrombosis 0.2% per patient-year, major bleeding event 0.6% per patient-year, paravalvular leak needing reoperation 0.5% per patient-year, prosthetic valve endocarditis 0.1% per patient-year, and of all reoperations 0.6% per patient-year. Conclusions. The CarboMedics Heart Valve Prosthesis has incidences of morbid events comparable with or better than reported for other mechanical valves. (C) 1998 by The Society of Thoracic Surgeons.