Real-World Early Outcomes of the Avalus Aortic Valve: Results From 1250 Patients in the Avalus Clinical confidencE Registry.

BACKGROUND: As cardiac surgery becomes more complex and patient profiles heterogeneous, real-world data are essential to evaluate bioprosthetic valve performance beyond controlled trials. The Avalus Clinical confidencE (ACE) registry evaluates safety and hemodynamic performance of the Avalus (Medtronic) bioprosthesis. METHODS: The ACE registry is a prospective, multicenter, single-arm, observational study including 1250 adult patients undergoing surgical aortic valve replacement with the Avalus valve in 27 European centers (2021-2024). Exclusion criteria were age <18 years and salvage surgery. Baseline characteristics, procedural details, and outcomes were collected. Echocardiography was performed at discharge and at 1 year. RESULTS: Mean age was 71.5 ± 6.5years, 22.2% female, and mean European System for Cardiac Operative Risk Evaluation-II was 3.5 ± 5.7. Isolated surgical aortic valve replacement was performed in 39.8% of patients; the remainder underwent combined procedures, most common was coronary artery bypass grafting (26%). Prosthesis sizes ranged from 19-29 mm, with a mean of 24.0 ± 2.2 mm; 18% of valves were 19-21 mm. Mean effective orifice area increased from 0.96 ± 0.63 cm2 preoperatively to 1.99 ± 0.60 cm2 at discharge and 1.80 ± 0.37 cm2 at 1 year. Mean gradients were low (discharge, 11.4 ± 5.1 mm Hg; 1 year, 12.2 ± 5.0 mm Hg). Patient-prosthesis mismatch rates at discharge were 20.8% moderate, and 4.8% severe; at 1 year, mismatch rates were 20.6% moderate, and 2.6% severe. CONCLUSIONS: In this 1250-patient, real-world registry, the Avalus valve demonstrated low gradients, favorable effective orifice area, and low severe patient-prosthesis mismatch rates, with reassuring early clinical outcomes across the spectrum of prosthesis sizes.