DOUBLE VALVE-REPLACEMENT WITH THE CARPENTIER-EDWARDS PERICARDIAL VALVE - 10-YEAR RESULTS

Background and aims of the study: The first generation of pericardial valves was withdrawn from the market because of an excessive rate of p remature failure. With an original design, the Carpentier-Edwards peri cardial valve promised improved results. Materials and methods: From J uly 1984 to December 1993, 71 patients underwent double mitral and aor tic valve replacement with the Carpentier-Edwards pericardial valve. M ean age was 63,4 years. 58% were male, mean clinical status was 2.9 wi th 71% of patients in NYHA class HILT or IV, 55% were in atrial fibril lation. All patients were followed for an average of 4.17 years after their operation, and total follow up was 296 patients years. Results: Operative mortality was 7% (5/71). At this point of the study, 70% of patients are in clinical NYHA class I or II, 42% of patients are in at rial fibrillation and 66% receive anticoagulation treatment. We observ ed 19 late deaths with an actuarial survival of 58% +/- 14% at ten yea rs. Valve-related complications include four endocarditis, four reoper ations, seven anticoagulant-related hemorrhages, two structural failur es, one thromboembolic episode, and one sudden death. Two patients die d of valve-related causes. After 10 years, freedom from valve related death is 97% +/- 3%, from endocarditis 90% +/- 8%, from reoperation 87 % +/- 10%, from thromboembolic complications 98% +/- 2%, from valve fa ilure 93% +/- 7%, and freedom from all complications is 58% +/- 18%. N o failure in patients older than 60 years was noted and no leaflet tea r was observed. Conclusions: The 10-year results of this pericardial b ioprosthesis make this valve an outstanding choice when a bioprosthesi s is required and in patients over 60 years old.