THE LAST GENERATION OF PERICARDIAL VALVES IN THE AORTIC POSITION - 10-YEAR FOLLOW-UP IN 589 PATIENTS

Background. The first generation of pericardial valves has been withdr awn from the market because of excessively high rates of premature fai lure. With its original design, the Carpentier-Edwards pericardial val ve has promised improved results. Methods. In our institution, 589 pat ients 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 patie nts were in New York Heart Association clinical class III or IV. The o perative 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 tot al follow-up was 2,408 patient-years. Results. At the time of the stud y, more than 85% of the patients were in New York Heart Association cl ass 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 f ailure, 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 endoc arditis (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 compl ications was 84% +/- 6%, from reoperation 97% +/- 2%, and from valve f ailure 96% +/- 4%. Conclusions. Because of its low rate of valve-relat ed 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.