7-Year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicenter analysis.

Objectives: Safety, efficacy, and durability are important considerations when selecting a bioprosthesis for aortic valve replacement (AVR). This study assessed 7-year clinical outcomes and haemodynamic performance of the Avalus bioprosthesis.

Methods: Patients indicated for surgical AVR were enrolled in this prospective, nonrandomized trial, conducted across 39 sites globally. The primary end-point of this analysis was freedom from surgical explant or percutaneous valve-in-valve reintervention due to structural valve deterioration (SVD) at 7 years of follow-up, determined using Kaplan-Meier (KM) analysis. We also evaluated a composite end-point of SVD or severe haemodynamic dysfunction (SHD) requiring reintervention. Survival, valve-related safety events, and haemodynamic performance were assessed. Deaths and safety events were adjudicated by an independent clinical events committee.

Results: A total of 1132 patients underwent surgical AVR. Mean age was 70 years; 854 patients (75%) were men. Mean STS risk of mortality was 2.0 ± 1.4%, and 659 patients (58%) had a NYHA classification of I/II. One or more concomitant procedures were performed in 577 patients (51%). At 7 years, the Kaplan-Meier rate of freedom from SVD/SHD requiring reintervention was 1.2% (0.5-2.5%) with no cases adjudicated as SVD. The survival rate was 82.6% (79.5-85.0%). The KM event rate was 5.7% (4.3-7.7%) for reintervention, 6.3% (4.9-8.3%) for endocarditis, and 0.4% (0.1-1.1%) for valve thrombosis. Mean aortic gradient, dimensionless velocity index, and effective orifice area were 13.8 ± 5.9 mmHg, 0.42 ± 0.09, and 1.99 ± 0.53 cm2, respectively.

Conclusions: This analysis demonstrated excellent durability of the Avalus valve with good clinical outcomes and stable haemodynamic performance through 7 years of follow-up.

Registration: www.clinicaltrials.gov ID: NCT02088554.