The CarboMedics prosthetic heart valve: a second generation bileaflet prosthesis

The CarboMedics prosthetic heart valve has been studied in more than 2,933 patients for a total of 6,298-patient years, with mean follow-up periods of as long as 36 months in patient populations typical for the standard practice of cardiac surgery. Surgical mortality rates have ranged from 4.9% to 7.5% with 1-,2-, and 3-year survival rates of 89% to 91.7%, 87% to 89.3%, and 84.4% to 86%, respectively. Actuarial freedom from thromboembolism at 1 year postoperative have been 98% to 98.7% for aortics, 96.8% to 97% for mitrals, and 96% to 97.8% for doubles. Linearized thromboembolism rates for all valve positions combined ranged from 0.5% to 1.74% per patient year. This and other valve-related complications were similar to reported figures for the St. Jude Medical valve. Rotatability of the CarboMedics valve after implantation is the most dramatic of the improvements that make this valve a worthy second generation bileaflet prosthesis. Technical aspects of handling the valve at implantation have posed no problems. There have been no reported instances of mechanical valve failure.