A single-center experience with 1,378 CarboMedics mechanical valve implants

Background. The CarboMedics bileaflet prosthetic heart valve was introduced in 1986. We first implanted it in March 1991. The purpose of this study was to analyze our clinical experience with this valve. Methods. Between March 1991 and December 1997, 1,378 valves were implanted in 1,247 patients, 705 men (56.5%) and 542 (43.5%) women with a mean age of 62 ± 11.9 years (± the standard deviation). Follow-up is 99% complete and totals 3,978 patient-years. Results. The early mortality rate was 4.4% (55/1,247). The survival rates at 1 year and 5 years were 91.8% ± 0.8% (± the standard error of mean) (n = 1,062) and 79.2% ± 1.4% (n = 281), respectively. Freedom from valve-related complications (linearized rate, 4.9% per patient-year) at 1 year and 5 years was 90.6% ± 0.8% (± the standard error of the mean) (n = 996) and 80.6% ± 1.4% (n = 243), respectively. Linearized rates for various complications were as follows: bleeding events, 1.73% per patient-year; embolic events, 1.76% per patient-year; operated valvular endocarditis, 0.18% per patient-year; valve thrombosis, 0.10% per patient year; and nonstructural dysfunction, 1.21% per patient-year. Freedom from reoperation at 1 year and 5 years was 98.6% ± 0.3% (± the standard error of the mean) (n = 1,070) and 97.7% ± 0.5% (n = 285), respectively. Conclusions. Midterm results demonstrate that the CarboMedics prosthetic heart valve exhibits a low incidence of valve-related complications.