LONG-TERM DURABILITY AND PATIENT FUNCTIONAL STATUS OF THE CARPENTIER-EDWARDS(R) PERIMOUNT(R) PERICARDIAL BIOPROSTHESIS IN THE AORTIC POSITION

Background and aims of the study: The study aim was to examine the lon g-term durability of the aortic Carpentier-Edwards(R) Perimount(R) per icardial bioprosthesis using actuarial and actual analyses, Methods:A total of 267 patients were implanted at four centers between September 1981 and December 1983, Of these patients, 171 (64%) were males and 9 6 (36%) females; mean age at implant was 64.9 +/- 11.8 years (range: 2 1 to 86 years), Patients have been followed for 9.1 +/- 4.2 years (tot al 2335.7 patient-years). Long-term echocardiography data are presente d, Results: The total operative (<30 days postoperative) mortality rat e was 4.9%; of this, 0.4% was valve-related, The total late (greater t han or equal to 30 days postoperative) mortality rate was 6.2%/pt-yr a nd included a valve-related mortality rate of 1.6%/pt-yr. Complication s of thromboembolism, thrombosis and bleeding showed linearized rates of 1.6%/pt-yr and 0.4%/pt-yr, respectively, Valve dysfunction resulted in an explant rate of 0.9%pt-yr and an associated mortality rate of 0 .1%/pt-yr. At 14 years post implant, actuarial freedom from overall an d valve-related death was 39.3% and 78.8%, respectively, Actuarial and actual freedom from valve dysfunction was 70.4% and 81.7%. Actuarial freedom from valve explant as a result ob: dysfunction was 85.1% in al l patients; explant in patients aged less than or equal to 65 years at implant was less (76.1%) than in patients aged >65 years (96.3%). Con clusion: The high actuarial and actual freedom from explant due to str uctural valve dysfunction supports the long-term durability of this pe ricardial bioprosthesis and justifies its clinical use in patients old er than 65 pears at implant.