Porcine bioprostheses for surgical aortic valve replacement: very long-term performance of a third-generation device

Abstract

Aims We aimed at investigating the long-term durability of the Epic bioprosthesis for surgical aortic valve replacement (SAVR) in a single-centre series of 888 implantations (2001–2018), expanding previous evaluations with shorter follow-up. Methods We retrieved prospectively collected in-hospital data and performed a systematic follow-up focusing on valve-related events (SVD, structural valve deterioration; PPM, patient–prosthesis mismatch; reoperation) (competing risks, CIF and Kaplan--Meier methods). We distinguished between SVD (permanent changes in valve function due to evolutive structural deterioration, ≥10 mmHg average gradient vs. reference echocardiography) and PPM. Results Average age at SAVR was 75.4 ± 7 years; 855 (96.3%) bioprostheses entered the follow-up and 396 (46.4%) were alive at last assessment. Follow-up was 99.9% complete, median duration was 7.7 years (entire cohort) and 9.9 years (survivors). At 10 years, overall survival was 50% ± 1.9, freedom from SVD was 99.4% ± 0.3 (competing risks) (seven SVD events after 8.1 ± 4.3 years). Freedom from SVD at 15 years was 98.4% ± 0.8 (competing risks). Prevalence of severe PPM was higher in 19 mm (6.5%) and 21 mm (10.2%) size cohorts. PPM (severe or moderate/severe) had no significant impact on overall survival (log-rank P = 0.27 and P = 0.21, respectively). Freedom from any reintervention (reoperation or TAVI Valve-in-Valve) for SVD at 10 years was 99.4% ± 0.3 (competing risks); freedom from any valve-related reintervention was 97.4% ± 0.6 (competing risks). Conclusion The Epic bioprosthesis for SAVR is limited by nonnegligible rates of PPM, which have nonetheless no impact on late survival. This device shows excellent durability and low rates of adverse valve-related events.