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The first generation of pericardial valves was withdrawn from the market because of an excessive rate of premature failure.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.