Comparison of Self-Expandable Acurate Neo-2 and Balloon-Expandable Myval Transcatheter Heart Valves at 4-Year Follow-Up

Background: Recently, Acurate neo2 (ACN2; Boston Scientific, US) and Sapien-3 series (Edwards Lifesciences, US) were compared in the IDE trial failing to demonstrate non-inferiority of ACN2. The Myval series (MyV), an alternative balloon-expandable device, demonstrated non-inferiority compared to Sapien-3 and Evolut (Medtronic, US) in the LANDMARK trial. However, no direct comparison exists between ACN2 and MyV. Aims: We aimed to compare mid-term clinical and hemodynamic outcomes of the ACN2 and MyV transcatheter heart valves. Methods: This multicenter retrospective analysis included patients implanted with ACN2 and MyV series devices. The primary objective was to assess 1-year mortality and stroke rates. Secondary outcomes included technical success, mortality, stroke, residual aortic regurgitation (AR), mean aortic gradients, and new permanent pacemaker implantation (PPI) rates up to 4 years. A matched comparison adjusting for clinical and anatomical characteristics was performed and echocardiograms were centrally analyzed. Results: A total of 545 patients (ACN2: 144; MyV: 401) from nine institutions were included. Matched technical success rates were 87.6% and 94.4%, p = 0.180 (90.3% for ACN2 and 97% for MyV; p < 0.001 in unmatched). In-hospital matched PPI rates were 10.1% for ACN2 and 9% for MyV. At 4 years, matched residual ≥ moderate AR rates were similar (ACN2: 15.8% vs. MyV: 21.1%, p = 0.706), though ACN2 showed better mean aortic gradients (9.2 ± 4.2 vs. 13.1 ± 5.4, p = 0.001) and effective orifice area. Unmatched mortality + stroke rates were comparable but lower for ACN2 after matching (3.4% vs. 15.7%, p = 0.005). Importantly, cardiovascular mortality (3.4% for ACN2 and 5.6% for MyV, p = 0.720) and valve-related deaths were comparable. Conclusion: ACN2 showed superior long-term hemodynamics and lower matched 4-year mortality and stroke rates, though cardiovascular mortality and valve-related deaths were comparable.