BACKGROUND: The lack of valve rotatability, the structural deterioration, and the rate of valve-related complications with the standard mechanical bileaflet prosthesis led to the development of a new second-generation bileaflet valve in 1986. METHODS: Between January 1989 and March 1994, 1,049 CarboMedics valves were implanted in 859 patients. The rotatability was used in 109 mitral prostheses (21.5%) and in 61 aortic prostheses (11.6%). Follow-up was 97.1% complete, with 3,049 patient-years. RESULTS: The hospital mortality was 6.9% for the mitral group, 3.4% for the aortic group, and 10.7% for the double-valve group (p < 0.005). The actuarial survival curve at 5 years was 77.3% +/- 3.6%, 90.1% +/- 2.5%, and 79.2% +/- 3.7% (p = 0.0003), freedom from thromboembolism was 89.1% +/- 3.6%, 87.1% +/- 3.8%, and 68.8% +/- 8.2%, freedom from reoperation was 95.9% +/- 1.4%, 98.9% +/- 0.6%, and 94.9% +/- 2.4%, and freedom from valve-related complications was 68.8% +/- 4.1%, 79.5% +/- 3.5%, and 55.3% +/- 5.9% after mitral, aortic, and mitral and aortic valve replacement, respectively. There were five episodes of valve thrombosis, but no structural deterioration occurred. CONCLUSIONS: The clinical performance of the CarboMedics valve is quite satisfactory, with a low incidence of valve-related mortality and morbidity. The rotatability feature was useful when the native valve was preserved or for repeat valve replacement.
BACKGROUND: The lack of valve rotatability, the structural deterioration, and the rate of valve-related complications with the standard mechanical bileaflet prosthesis led to the development of a new second-generation bileaflet valve in 1986. METHODS: Between January 1989 and March 1994, 1,049 CarboMedics valves were implanted in 859 patients. The rotatability was used in 109 mitral prostheses (21.5%) and in 61 aortic prostheses (11.6%). Follow-up was 97.1% complete, with 3,049 patient-years. RESULTS: The hospital mortality was 6.9% for the mitral group, 3.4% for the aortic group, and 10.7% for the double-valve group (p < 0.005). The actuarial survival curve at 5 years was 77.3% +/- 3.6%, 90.1% +/- 2.5%, and 79.2% +/- 3.7% (p = 0.0003), freedom from thromboembolism was 89.1% +/- 3.6%, 87.1% +/- 3.8%, and 68.8% +/- 8.2%, freedom from reoperation was 95.9% +/- 1.4%, 98.9% +/- 0.6%, and 94.9% +/- 2.4%, and freedom from valve-related complications was 68.8% +/- 4.1%, 79.5% +/- 3.5%, and 55.3% +/- 5.9% after mitral, aortic, and mitral and aortic valve replacement, respectively. There were five episodes of valve thrombosis, but no structural deterioration occurred. CONCLUSIONS: The clinical performance of the CarboMedics valve is quite satisfactory, with a low incidence of valve-related mortality and morbidity. The rotatability feature was useful when the native valve was preserved or for repeat valve replacement.