Long-term results of the carpentier-edwards supraannular aortic valve prosthesis.

Background: We evaluate the clinical results of the Carpentier-Edwards supraannular (CE SAV) aortic bioprosthesis at long-term follow-up (over 25 years).

Methods: Between 1983 and 1994, 1,002 CE SAV prostheses were implanted. Data were prospectively collected, retrospectively analyzed, and stratified by age groups at the time of surgery (group 1, ≤60 years; group 2, 61 to 70 years; group 3, >70 years), using both the actuarial and the "actual" (cumulative risk) methods.

Results: The operative mortality was 11.3% (valve-related in 2 cases). Follow-up included 8,164.09 patient-years (average 13.7±6.6 years, up to 26.9 years). Overall survival at 25 years was significantly higher in group 1 (p<0.001). Freedom from structural valve deterioration (SVD) at 15 years was 85.9% (actuarial) and 94.8% (actual). Freedom from reoperation for SVD was 91.8% (actuarial) and 97% (actual). There were no significant differences in valve-related endpoints among group 2 and group 3. Death was valve-related in 11.3%. Younger age at surgery was associated with higher incidence but not earlier presentation of SVD. Freedom from any valve-related complication at 15 years was 23.6%, 66%, and 68% in groups 1, 2, and 3 (actuarial), and 38.9%, 76.1%, and 81.2%, respectively (actual) (p=0.6 among groups 2 and 3).

Conclusions: The CE SAV bioprosthesis provides similar outcomes (SVD and reoperation) in patients aged 61 to 70 years and older individuals. Use of a bioprosthesis is justified in patients older than 60 years. Younger patients may be rightfully informed over the expected durability of the prosthesis.