Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis†

OBJECTIVES: We assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™). METHODS: The PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. Death, valve-related adverse events (AEs), functional recovery and haemodynamic performance were assessed at discharge, 3–6 months and 1 year. The primary analysis compared ‘late’ (>30 days post-implant) linearized rates of valve-related thromboembolism, thrombosis, all and major haemorrhage, all and major paravalvular leak (PVL) and endocarditis after implantation with objective performance criteria (OPC) for AEs, in accordance with EN ISO 5840:2009. We hypothesized that the upper 95% confidence bounds of the true linearized AE rates would be ≥ 2 × OPC; rejection of the null hypothesis would demonstrate that these rates were below acceptable rates. The analysis was required to include at least 150 patients followed to 1 year and 400 valve-years. Kaplan–Meier survival analysis was also performed. RESULTS: Total number of valve-years was 459.5 (n = 686). Linearized rates were <2 × OPC for death and valve-related thromboembolism, valve thrombosis, all and major PVL, and endocarditis, but ≥2 × OPC for all and major haemorrhage. Survival at 1 year (n = 270) was 96.4%. Patients showed good functional recovery, and haemodynamic performance was within expected range. CONCLUSIONS: This analysis demonstrated a good safety profile and clinical effectiveness of the Avalus valve except for bleeding rates. The linearized rates of all and major haemorrhage may be related to long-term anticoagulation for non-valvular indications and the length of follow-up of this cohort. TRIAL REGISTRATION: NCT02088554 (www.clinicaltrials.gov).