An international experience with the CarboMedics prosthetic heart valve.

A multi-center, international, prospective trial of the CarboMedics valve was initiated in September 1987. Twenty-five centers were included for the purpose of demonstrating the clinical effectiveness of this new rotatable bileaflet Pyrolite carbon prosthesis. The study included 1228 patients (1372 valves) enrolled between September 1987 and September 1993. There were 674 males and 554 females from ages two to 84 years. There were 603 aortic, 476 mitral and 144 double valve implants. Mean follow up time was 30.2 months; 96.3% of patients had completed documentation up to and including one year. Functional class was III or IV for 87.1% of patients preoperatively, and I or II in over 96% of patients for the first five post-operative years. Survival for the entire group was 89% (n = 902) at one year, 84% (n = 463) at three years, and 81% (n = 92) at five years. There were no significant survival differences between the aortic and mitral valve replacement groups. Statistically significant differences in survival (p < or = 0.1) for all patients (primary and non-primary) were found to be associated with female gender (p = .0097), increasing age (p = 0.0001), increasing preoperative NYHA classification (p = 0.0001), concomitant procedures performed during surgery (p = .0001), double valve replacement (p = 0.0622), and presence of preoperative endocarditis (p = .0829). Late deaths totaled 88 with 46 of those classified as valve-related. There was no valve failure.(ABSTRACT TRUNCATED AT 250 WORDS)