Carpentier-Edwards supraannular porcine bioprosthesis evaluation over 15 years

The Carpentier-Edwards supraannular porcine bioprosthesis experience during 15 years has been evaluated to determine the incidence of structural valve deterioration by valve position in various age groupings.

From 1981 to 1995, 2,943 patients older than 20 years had the prosthesis implanted in 3,024 procedures. The mean age of the population was 65.5+/-11.9 years (range, 21 to 89 years). Aortic valve replacement was performed in 1,657 patients (54.8%); mitral valve replacement, 1,092 (36.1%); multiple valve replacement, 253 (8.3%); pulmonary valve replacement, 2 (0.1%); and tricuspid valve replacement, 20 (0.7%). Concomitant procedures were performed in 1,332 patients (45.3%), and 352 (12.0%) had previous procedures.

The early mortality was 8.9% (270), only 0.4% (11) valve-related. The total follow-up was 17,471 years (mean, 5.9+/-4.1 years). The late mortality was 5.2%/ patient-year (901) with the valve-related component 1.0%/patient-year (171). The reoperation rate was 2.1%/ patient-year (369) with 4.3% mortality (16). The linearized rate of structural valve deterioration was 2.0%/patient-year (341), and overall complications, 5.9%/patient-year (1,019). The overall survival, at 15 years, was 31.1%+/2.8% (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 12 years, for patients older than 70 years, 95.3%+/-2.7%; 61 to 70 years, 92.9%+/-2.1%; 51 to 60 years, 70.1%+/-5.3%; 41 to 50 years, 60.0%+/-8.8%; and 21 to 40 years, 75.7%+/-7.3%. The freedom from structural valve deterioration for mitral valve replacement was, at 12 years, for patients older than 70 years, 66.1%+/-9.7%; 61 to 70 years, 53.1%+/-4.7%; 51 to 60 years, 52.6%+/-5.5%; 41 to 50 years, 39.3%+/-6.9%; and 21 to 40 years, 42.1%+/-9.4%.

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 (when extended longevity is not anticipated).