Late outcomes for aortic valve replacement with the Carpentier-Edwards pericardial bioprosthesis: up to 17-year follow-up in 1,000 patients.

Background: This study reviews a single institution experience with the Carpentier-Edwards pericardial aortic valve bioprosthesis, concentrating on late outcomes.
Methods: From December 1991 to June 2002, 1,000 patients underwent aortic valve replacement with the Carpentier-Edwards pericardial valve (mean follow-up 6.01 +/- 3.56 years). The institutional database was reviewed. Follow-up data were acquired through telephone interviews and mail-in questionnaires. Time-to-event analyses were performed by the Kaplan-Meier method. Mean age was 74.1 years; 545 patients (54.5%) were male. Mean preoperative ejection fraction was 52.5%. Isolated aortic valve replacement occurred in 372 cases (37.2%). Combined aortic valve replacement with coronary artery bypass grafting occurred in 443 cases (44.3%). The remaining 185 patients (18.5%) underwent complex procedures with concomitant mitral, tricuspid, or arch repair. One hundred forty patients (14.0%) had prior aortic valve surgery. Follow-up was 99.4% complete.
Results: Overall operative mortality was 7.2% (72 of 1,000). There were 503 late deaths (50.3%). Age-stratified survival at 15 years was 43.7% for patients less than 65 years of age; 18.2% for patients aged 65 to 75; and 9.4% for patients aged more than 75 years. There were 26 failed bioprostheses (2.6%) requiring reoperation. Structural valve deterioration was the cause in 13 of 26 cases (50%), endocarditis in 11 of 26 (42%), and perivalvular leak in 2 of 26 (7.6%). Age-stratified freedom from reoperation due to structural valve deterioration at 15 years was 34.7% for patients less than 65 years of age; 89.4% for patients aged 65 to 75; and 99.5% for patients aged more than 75 years.
Conclusions: The Carpentier-Edwards pericardial bioprosthesis shows long-term durability with low rates of structural failure.
(Copyright (c) 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)