Comparison of transcatheter aortic valve replacement with the ACURATE neo2 versus Evolut PRO/PRO+ devices

DOI: 10.4244/EIJ-D-22-00498

Sara Baggio
Sara Baggio1, MD; Matteo Pagnesi2, MD; Won-Keun Kim3, MD; Andrea Scotti4, MD; Marco Barbanti5, MD; Giuliano Costa5, MD; Marianna Adamo2, MD; Ran Kornowski6, MD; Hana Vaknin-Assa6, MD; Rodrigo Estévez-Loureiro7; Robert Alarcón Cedeño7, MD; Federico De Marco8, MD; Matteo Casenghi8, MD; Stefan Toggweiler9, MD; Verena Veulemans10, MD; Darren Mylotte11, MD; Mattia Lunardi11, MD; Damiano Regazzoli1, MD; Bernhard Reimers1, MD; Lars Søndergaard12, MD; Maarten Vanhaverbeke12, MD, PhD; Philippe Nuyens12, MD; Diego Maffeo13, MD; Andrea Buono13, MD; Matteo Saccocci13, MD; Francesco Giannini14, MD; Luca Di Ienno14, MD; Marco Ferlini15, MD; Giuseppe Lanzillo15, MD; Alfonso Ielasi16, MD; Joachim Schofer17, MD; Christina Brinkmann17, MD; Jan Van Der Heyden18, MD; Ian Buysschaert18, MD; Amnon Eitan19, MD; Alexander Wolf20, MD; Martin Marian Adamaszek20, MD; Antonio Colombo1, MD; Azeem Latib4, MD; Antonio Mangieri1, MD
1. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy and Cardio Center, Humanitas Research Hospital IRCCS, Rozzano, Milan, Italy; 2. Cardiothoracic Department, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy and Department of Medical Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy; 3. Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany; 4. Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA; 5. Division of Cardiology, A.O.U. Policlinico "G. Rodolico-San Marco", Catania, Italy; 6. Department of Cardiology, Rabin Medical Center, Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel; 7. Cardiology Department, University Hospital Alvaro Cunqueiro, Galicia Sur Health Research Institute, Vigo, Spain; 8. Department of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy; 9. Department of Cardiology, Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland; 10. Division of Cardiology, Pulmonology and Vascular Medicine, Heinrich Heine University, Medical Faculty, Düsseldorf, Germany; 11. Galway University Hospital, SAOLTA Health Care Group, and National University of Ireland, Galway, Ireland; 12. Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 13. Fondazione Poliambulanza, Brescia, Italy; 14. Interventional Cardiology Unit, GVM Care & Research, Maria Cecilia Hospital, Cotignola, Italy; 15. Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; 16. Clinical and Interventional Cardiology Unit, Clinical Institute Saint Ambrogio, Milan, Italy; 17. Medizinisches Versorgungszentrum, Hamburg, Germany; 18. Interventional Cardiology Unit, AZ Sint-Jan Hospital, Brugge, Belgium; 19. Department of Cardiology, Carmel Medical Center, Haifa, Israel; 20. Klinik für Kardiologie, Elisabeth-Krankenhaus Essen, Essen, Germany

Background: The ACURATE neo2 (NEO2) and Evolut PRO/PRO+ (PRO) bioprostheses are new-generation self-expanding valves developed for transcatheter aortic valve replacement (TAVR).

Aims: We sought to compare the performance of the ACURATE neo2 and Evolut PRO/PRO+ devices.

Methods: The NEOPRO-2 registry retrospectively included patients who underwent TAVR for severe aortic stenosis with either the NEO2 or PRO devices between August 2017 and December 2021 at 20 centres. In-hospital and 30-day Valve Academic Research Consortium (VARC)-3 defined outcomes were evaluated. Propensity score (PS) matching and binary logistic regression were performed to adjust the treatment effect for PS quintiles. A subgroup analysis assessed the impact of aortic valve calcification.

Results: A total of 2,175 patients (NEO2: n=763; PRO: n=1,412) were included. The mean age was 82±6.2 years and the mean Society of Thoracic Surgeons score was 4.2%. Periprocedural complications were low, and both groups achieved high rates of technical success (93.1% vs 94.1%; p=0.361) and predischarge intended valve performance (96.0% vs 94.1%; p=0.056), both in the unmatched and matched analysis (452 pairs). Device success at 30 days was comparable (84.3% vs 83.6%; p=0.688), regardless of aortic valve calcification severity (p>0.05 for interaction). A suggestion for higher VARC-3 early safety in the NEO2 group was mainly driven by reduced rates of new permanent pacemaker implantation (7.7% vs 15.6%; p<0.001).

Conclusions: This retrospective analysis reports a similar short-term performance of the ACURATE neo2 platform compared with the new-generation Evolut PRO/PRO+ devices. Randomised studies are needed to confirm our exploratory findings.

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aortic stenosisatrio-ventricular blockconduction abnormalitiesmsctparavalvular leaktavi
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