The CarboMedics Valve: Experience With 1,049 Implants

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.