Carpentier-Edwards supraannular porcine bioprosthesis evaluation over 15 years

Background. The Carpentier-Edwards supraannular porcine bioprosthesis exper ience during 15 years has been evaluated to determine the incidence of stru ctural valve deterioration by valve position in various age groupings. Methods. From 1981 to 1995, 2,943 patients older than 20 years had the pros thesis 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 per formed 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 procedur es. Results. 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 m ortality 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 w as 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) aor tic valve replacement greater than mitral valve replacement or multiple val ve 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 fr eedom 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 ye ars, 53.1% +/- 4.7%; 51 to 60 years, Io 52.6% +/- 5.5%; 41 to 50 years, 39. 3% +/- 6.9%; and 21 to 40 years, 42.1% +/- 9.4%. Conclusions. The prosthesis is recommended for aortic valve replacement for patients older than 70 years and for patients 61 to 70 years (when extende d longevity is not anticipated) and for mitral valve replacement for patien ts older than 70 years (when extended longevity is not anticipated). (C) 19 98 by The Society of Thoracic Surgeons.