Comparison of Self-Expandable Acurate Neo-2 and Balloon-Expandable Myval Transcatheter Heart Valves at 4-Year Follow-Up
Jain A. Jose J. Montorfano M. Nissen H. Martin P. Seth A. Stambuk K. Gunasekaran S. Mussayev A. García-Gómez M. Fernandez-Cordón C. Campo A. Rodriguez M. Jorgensen M.D. Campillo S. Carrasco-Moraleja M. Román A.S. Amat-Santos I.J.
1 September 2025John Wiley and Sons Inc
Catheterization and Cardiovascular Interventions
2025#106Issue 32005 - 2017 pp.
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.
Acurate neo 2 , aortic stenosis , Myval , TAVR
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Cardiology Department, University Clinic Hospital of Valladolid, Valladolid, Spain
Christian Medical College, Vellore, India
School of Medicine, Vita-Salute San Raffaele University, Milan, Italy
Interventional Cardiology Unit IRCCS San Raffaele Scientific Institute, Milan, Italy
Odense University Hospital, Odense, Denmark
Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Spain
Fortis Escorts Heart Institute, New Delhi, India
Magdalena Clinic for Cardiovascular Diseases, Krapinske, Croatia
Apollo Hospital, New Delhi, India
UMC Heart Center, Astana, Kazakhstan
Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain
Cardiology Department
Christian Medical College
School of Medicine
Interventional Cardiology Unit IRCCS San Raffaele Scientific Institute
Odense University Hospital
Hospital Universitario de Gran Canaria Dr Negrin
Fortis Escorts Heart Institute
Magdalena Clinic for Cardiovascular Diseases
Apollo Hospital
UMC Heart Center
Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV)
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