CARPENTIER-EDWARDS SUPRAANNULAR PORCINE BIOPROSTHESIS - CLINICAL-PERFORMANCE TO 12 YEARS

The Carpentier-Edwards supraannular porcine bioprosthesis, a second-ge neration biologic prosthesis, has had clinical performance assessment to 12 years. This bioprosthesis was used in 2,489 operations in 2,444 patients between 1982 and 1992, inclusive (mean age 64.1 years, age ra nge 6 to 89 years). There were 1,335 aortic valve replacements (AVR), 938 mitral valve replacements (MVR), and 200 multiple valve replacemen ts (MR). Concomitant procedures were performed in 1,017 cases (40.9%). The age group distribution was: 35 years or younger, 83 patients; 36 to 50 years, 245; 51 to 64 years, 728; 65 to 69 years, 458 and 70 year s and older, 975. The total follow-up was 12,785 patient-years (mean, 5.1 years) and was 96% complete. The early mortality rate was 7.4% (18 5 patients), and the late mortality was 4.9%/patient year (623). Conco mitant procedures influenced both early and late mortality (p < 0.05). The overall patient survival at 12 years was 44% +/- 3% (p < 0.05, AV R > MVR, MR). The freedom from thromboembolism was not different by va lve position. The freedom from major thromboembolism at 12 years was 8 2% +/- 4% (p = not significant by valve position). The overall freedom from antithromboembolic hemorrhage was 96% +/- 1% at 12 years (p < 0. 05, AVR > MVR > MR). The overall freedom from valve-related reoperatio n at 12 years was 58% +/- 5% (p < 0.05, AVR > MVR, MR), and from valve -related mortality 89% +/- 2% (p < 0.05, AVR > MVR > MR). The freedom from residual morbidity (permanent impairment) at 12 years was 87% +/- 4% (p = not significant by valve position). The freedom from structur al valve deterioration overall at 12 years was 63% +/- 5%; at 10 years it was 90% +/- 2% for AVR, 72% +/- 3% for MVR, and 61% +/- 8% for MR (p < 0.05, AVR > MVR, MR). The freedom from structural valve deteriora tion by age groups by valve position was not significant for 35 years and less, but was significant for 36 to 50, 51 to 64, and 70 years and older (p < 0.05, AVR > MVR > MR), and for 65 to 69 years (p < 0.05, A VR > MR > MVR). The freedom from structural valve deterioration at 10 years after AVR by valve position for age groups was 36 to 50 years, 8 5% +/- 6%; 70 years and older, 99% +/- 1%; 51 to 64 years, 84% +/- 4%; and 65 to 69 years, 96% +/- 2% (p < 0.05). The freedom from structura l valve deterioration at 10 years for MVR and MR was not different by age groups; for ages greater than 70, rates were 90% +/- 4% for MVR an d 84% +/- 12% for MR. The second-generation Carpentier-Edwards supraan nular porcine bioprosthesis has structural valve deterioration as a ma jor valve-related complication, but is recommended for AVR in patients 65 years of age or older and for MVR in those aged 70 years or more.