Carpentier-Edwards standard porcine bioprosthesis: clinical performance to seventeen years.

BACKGROUND: The role of porcine bioprostheses in cardiac valve replacement has been under review for several years. The literature deals primarily with age as a determinant of durability, as well as the intermediate-term performance of various prostheses. The performance of the Carpentier-Edwards first-generation standard porcine bioprosthesis is presented over the long-term with further documentation on age determinants.
METHODS: The "Guidelines for Reporting Morbidity and Mortality After Cardiac Valvular Operations" were used for definitions of valve-related complications, categorization, and statistical methods. The valve-related complications were evaluated in a time-related manner by actuarial life-table techniques. The Lee-Desu statistic test was used for comparison of performance by valve positions and age groups. Hazard function rates were demonstrated for complications and composites.
RESULTS: Of the Carpentier-Edwards porcine bioprostheses implanted in 1,195 patients (1,214 operations, 1,315 valves) commencing in 1975 the early mortality was 7.6% (92). The early mortality without concomitant procedures was 6.1% and with 11.7%. The late mortality was 5.3% per patient-year; 4.6% patient-year without and 7.5% per patient-year with concomitant procedures. The valve-related causes of late mortality (131) were thromboembolism (41), antithromboembolic hemorrhage (14), prosthetic valve endocarditis (20), nonstructural dysfunction (12), and structural valve deterioration (44). The valve-related deaths (early, 7; late, 124) were 21.2% of the total 617 total deaths. Reoperation for valve-related complications was performed in 406 patients (4.1% per patient-year), of which 327 were for structural valve deterioration (3.3% per patient-year). Mortality for reoperation was 0.5% per patient-year (49 patients) or 12.1%. Of the 49 deaths, 33 were caused by structural valve deterioration. The linearized occurrence rate for thromboembolism was 1.6% per patient-year (major, 0.9% per patient-year, and minor, 0.7% per patient-year). The fatal thromboembolic rate was 0.4% per patient-year (41), undifferentiated by valve position. The freedom from thromboembolism was 76% at 17 years (p = not significant by valve position) (major, 87%; fatal, 93%). The freedom from prosthetic valve endocarditis was 92% at 17 years (p = not significant by valve position). The freedom from reoperation, at 15 years, was 38%: aortic (AVR), 55%; mitral (MVR), 20%; and multiple valve replacement (MR), 24% (p < 0.05 AVR > MVR, MR). The freedom from structural valve deterioration, at 15 years, was 41%; AVR, 58%; MVR, 21%; MR, 36% (p < 0.05 AVR > MVR, MR). The freedom from structural valve deterioration was greater for advancing age groups (p < 0.05); AVR > or = 70 years 96% at 12 years, and 65 to 69 years 94% at 12 years and 82% at 15 years; MVR > or = 70 years 85% at 12 years, and 65 to 69 years 54% at 12 years. The freedom from valve-related mortality was 73% at 17 years: AVR, 80%; ; MVR, 61%; and MR, 67% (p < 0.05 AVR > MVR, MR). The freedom valve-related residual morbidity was 94% (p = not significant by valve position).
CONCLUSIONS: The Carpentier-Edwards standard porcine bioprosthesis continues to provide satisfactory clinical performance to 17 years. Thromboembolism is a more serious problem than structural failure: 92 major thromboembolic events with 41 fatalities compared with 44 fatalities of which 33 occurred with reoperation. The prosthesis is especially recommended for patients more than 65 years of age for AVR and more than 70 years of age for MVR.