Carpentier-Edwards standard porcine bioprosthesis: a 21-year experience

Abstract

Background. The Carpentier-Edwards standard porcine bioprosthesis experience to 21 years has been evaluated to determine the influence of structural valve deterioration by valve position in various age groupings. Methods. From 1975 to 1988, 1,181 patients had the prosthesis implanted in 1,198 procedures. The mean age of the population was 57.9 ± 12.5 years (range, 21 to 85 years). Aortic valve replacement was performed in 564 patients (47.8%); mitral valve replacement, 478 (40.5%); and multiple valve replacement, 132 (11.2%). Concomitant procedures were performed in 337 patients (28.5%), and 140 (11.9%) had previous operations. Results. The early mortality was 8.1% (97), only 0.4% (5) of which were valve-related. The total follow-up was 10,405 years (mean, 8.8 ± 5.2 years). The late mortality was 5.7%/patient-year (591), with the valve-related component 1.6%/patient-year (168) with a 13% reoperative mortality (56). The linearized rate of structural valve deterioration was 3.8%/patient-year (395), with overall complications of 7.1%/patient-year (737). The overall survival at 20 years was 17.2% ± 3.1% ( p < 0.05; aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration was, at 18 years, 25.8% ± 2.8% overall, AVR 40.6% ± 4.2%, and MVR 8.5% ± 3.4% ( p < 0.05, aortic valve replacement greater than mitral valve replacement or multiple valve replacement). The freedom from structural valve deterioration for aortic valve replacement was, at 15 years, for patients older than 70 years, 82.9% ± 9.1%; 61 to 70 years, 73.2% ± 4.7%; 51 to 60 years, 58.8% ± 5.4%; 41 to 50 years, 41.7% ± 8.2%; and 21 to 40 years, 25.5% ± 7.8%. The freedom from structural valve deterioration for mitral valve replacement was, at 15 years, for patients older than 70 years, 89.8% ± 7.6%; 61 to 70 years, 22.8% ± 6.3%; 51 to 60 years, 26.3% ± 5.7%; 41 to 50 years, 11.7% ± 5.6%; and 21 to 40 years, 7.0% ± 4.7%. Conclusions. The prosthesis is recommended for aortic valve replacement for patients older than 70 years and for patients 61 to 70 years (when extended longevity is not anticipated) and for mitral valve replacement for patients older than 70 years.