Background and aims of the study: The first generation of pericardial valves was withdrawn from the market because of an excessive rate of premature failure. With an original design, the Carpentier-Edwards pericardial valve promised improved results.
Materials and methods: From July 1984 to December 1993, 71 patients underwent double mitral and aortic valve replacement with the Carpentier-Edwards pericardial valve. Mean age was 63.4 years. 58% were male, mean clinical status was 2.9 with 71% of patients in NYHA class III or IV, 55% were in atrial fibrillation. 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 atrial fibrillation and 66% receive anticoagulation treatment. We observed 19 late deaths with an actuarial survival of 58% +/- 14% at ten years. Valve-related complications include four endocarditis, four reoperations, seven anticoagulant-related hemorrhages, two structural failures, one thromboembolic episode, and one sudden death. Two patients died 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 failure 93% +/- 7%, and freedom from all complications is 58% +/- 18%. No failure in patients older than 60 years was noted and no leaflet tear was observed.
Conclusions: The 10-year results of this pericardial bioprosthesis make this valve an outstanding choice when a bioprosthesis is required and in patients over 60 years old.