Seven-and-a-half years clinical experience with the CarboMedics prosthetic heart valve

Seven and a half year clinical experience with the CarboMedics prosthetic heart valve is presented. A total of 287 valves were inserted in 277 patients. The first 132 patients were followed in a prospective, and the remaining 145 patients in a partly prospective and partly retrospective manner. The follow up was 98.9% complete with a total of 1,055 patient-years. Actuarial survival at 7.5 years was 74.0% +/- 3.5% overall; 76.0% +/- 4.3% for single aortic, 75.0% +/- 6.5% for single mitral and 76.0% +/- 11.4% for double valve replacements. The actuarial rates of freedom from complications were as follows: valve thrombosis 99.6% +/- 0.4%, embolism 96.0% +/- 1.7%, and anticoagulant-related bleeding 88.0% +/- 2.4%. There was no hemolysis, prosthetic valve dysfunction, or structural deterioration. The linearized rates per 100 patients-years were as follows: valve thrombosis 0.09 (mitral 0.30); embolism 0.75 (aortic 0.31, mitral 1.80); anticoagulant related bleeding 2.84; paravalvular leakage overall 0.19 (aortic 0.31); prosthetic valve endocarditis 0.19 (aortic 0.31). Over a 7.5-year time frame, the CarboMedics prosthetic heart valve has been highly reliable with a low incidence of valve related complications.