The CarboMedics Prosthetic Heart Valve in the Mitral Position: Results of the Multicenter International Trial

A bstract Isolated mitral valve replacement using the CarboMedics prosthetic mitral valve (CarboMedics, Inc., Austin, TX) was studied in 13 centers in the United States, Canada, and Scandinavia between 1987 and 1993 in 428 patients with a mean age of 57 ± 14 years. Actuarial survivals at 1, 2, and 5 years were 88.2% and 75.8%. Freedom from events at 5 years were 94.8% for major thromboembolism, 96.6% for thrombosis, and 96.7% for endocarditis. Linearized morbidity rates (events per 100 patient years) for events at > 30 days postoperatively were .51 thrombosis, 1.1 major thromboembolism, and .37 endocarditis. These results at early to mid-term compare favorably with the first generation bileaflet valve.