The last generation of pericardial valves in the aortic position: ten-year follow-up in 589 patients.

BACKGROUND The first generation of pericardial valves has been withdrawn from the market because of excessively high rates of premature failure. With its original design, the Carpentier-Edwards pericardial valve has promised improved results. METHODS In our institution, 589 patients underwent an isolated aortic valve replacement with a Carpentier-Edwards pericardial bioprosthesis between July 1984 and December 1993. The patients' mean age was 67.5 +/- 11.2 years, and 49% of the patients were in New York Heart Association clinical class III or IV. The operative mortality rate was 2.3% (14 of 595). All patients but 4 were followed up for an average of 4.1 years after their operation, and total follow-up was 2,408 patient-years. RESULTS At the time of the study, more than 85% of the patients were in New York Heart Association class I or II. There were 79 late deaths. After 10 years, the actuarial survival rate was 71% +/- 7%. Nineteen patients died of valve-related causes (3 endocarditis, 7 thromboembolic complications, 1 structural failure, and 8 sudden deaths). The actuarial rate of freedom from valve-related death was 94% +/- 3% at 10 years. Valve-related complications included 23 thromboembolic episodes (0.9% per patient-year), 14 endocarditis (0.5% per patient-year), 9 reoperations (0.4% per patient-year), and 4 structural valve failures with calcification and stenosis (0.2% per patient-year). After 10 years, freedom from valve-related complications was 84% +/- 6%, from reoperation 97% +/- 2%, and from valve failure 96% +/- 4%. CONCLUSIONS Because of its low rate of valve-related events at 10 years and low rate of structural deterioration with no leaflet tears, this prosthesis is an outstanding choice for patients who need tissue valves and for patients aged 60 years or older.