4-YEAR EXPERIENCE WITH THE CARBOMEDICS VALVE - THE NORTH-AMERICAN EXPERIENCE

A multicenter prospective trial of the CarboMedics valve was initiated in July 1988. Twelve North American centers were included for the pur pose of establishing the safety and efficacy of this new rotatable, bi leaflet, pyrolytic-Carbon prosthesis. The study included 786 patients (using 891 valves) enrolled between July 1988 and August 1992. There w ere 447 male and 339 female patients from ages 2 to 83 years. Of the 6 18 primary replacement operations (including double valves), 393 were aortic and 292 were mitral valve replacements. Mean follow-up time was 16.1 months; 94.7% of patients had completed documentation up to and including one year. New York Heart Association functional class was II I or IV for 84.4% of patients preoperatively, and I and II in over 96% of patients for the first three postoperative years. Survival for the entire group was 93% (622) at 1 month, 89% (504) at 1 year, 87% (213) at 2 years, and 85% (41) at 3 years. There were no significant surviv al differences between primary and repeat replacements or between aort ic, mitral, and double-valve replacements. Primary replacement patient s with concomitant procedures (n = 241) had slightly decreased surviva l rates compared with those who underwent isolated procedures (isolate d survival rate, 92% [98]; concomitant procedure survival rate, 81% [5 9] at 2 years; p = 0.002). There was no valve failure. Linearized rate s (events per 100 patient-years) in primary replacement patients after 30 days included the following: thrombosis, 0.39; thromboembolism, 0. 92; hemolysis, 0.53; anticoagulant-related hemorrhage, 2.36; paravalvu lar leak, 0.92; endocarditis, 0.53; reoperation, 0.92; and explantatio n, 0.66. We conclude that this valve, which recently has been recommen ded for approval by the Food and Drug Administration advisory panel, i s safe and efficacious for use.