Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2

DOI: 10.4244/EIJ-D-22-00289

Andrea Scotti
Andrea Scotti1,2, MD; Matteo Pagnesi3, MD; Won-Keun Kim4, MD; Ulrich Schäfer5, MD; Marco Barbanti6, MD; Giuliano Costa6, MD; Sara Baggio7, MD; Matteo Casenghi8, MD; Federico De Marco8, MD; Maarten Vanhaverbeke9, MD, PhD; Lars Søndergaard9, MD; Alexander Wolf10, MD; Joachim Schofer11, MD; Marco Bruno Ancona12, MD; Matteo Montorfano12, MD; Ran Kornowski13, MD; Hana Vaknin Assa13, MD; Stefan Toggweiler14, MD; Alfonso Ielasi15, MD; David Hildick-Smith16, MD; Stephan Windecker17, MD; Albrecht Schmidt18, MD; Andrea Buono19, MD; Diego Maffeo19, MD; Dimytri Siqueira20, MD; Francesco Giannini21, MD; Marianna Adamo3, MD; Mauro Massussi3, MD; David A. Wood22, MD; Jan-Malte Sinning23, MD; Jan Van der Heyden24, MD; Dirk-Jan van Ginkel25, MD; Nicholas Van Mieghem26, MD; Verena Veulemans27, MD; Darren Mylotte28, MD; Vasileios Tzalamouras29, MD; Maurizio Taramasso30, MD; Rodrigo Estévez-Loureiro31, MD, PhD; Antonio Colombo7, MD; Antonio Mangieri7, MD; Azeem Latib1, MD
1. Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA; 2. Cardiovascular Research Foundation, New York, NY, USA; 3. ASST Spedali Civili di Brescia and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy; 4. Department of Cardiology and Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany; 5. Department of Cardiology, University Heart & Vascular Center, Hamburg, Germany; 6. Department of Cardiology, C.A.S.T. Policlinic G. Rodolico Hospital, University of Catania, Catania, Italy; 7. Cardio Center, Humanitas Research Hospital, Rozzano-Milan, Italy; 8. Department of Cardiology, IRCCS Policlinico San Donato, Milan, Italy; 9. The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 10. Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Essen, Germany; 11. Department for Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany; 12. Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy; 13. Department of Cardiology, Rabin Medical Center-Beilinson Hospital, Petah Tikva, Israel; 14. Department of Cardiology, Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland; 15. Clinical and Interventional Cardiology Unit, Istituto Clinico Sant'Ambrogio, Milan, Italy; 16. Department of Cardiology, Royal Sussex County Hospital, Brighton, United Kingdom; 17. Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; 18. Division of Cardiology, Medical University of Graz, Graz, Austria; 19. Interventional Cardiology Unit, Fondazione Poliambulanza, Brescia, Italy; 20. Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil; 21. GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy; 22. Centre for Heart Valve Innovation, St. Paul’s and Vancouver General Hospital, Vancouver, BC, Canada; 23. Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany; 24. Sint-Jan Hospital, Bruges, Belgium; 25. Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands; 26. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; 27. Division of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Düsseldorf, Düsseldorf, Germany; 28. Department of Cardiology, Galway University Hospital, Galway, Ireland; 29. Cardiology, King's College Hospital, London, United Kingdom; 30. Division of Cardiothoracic Surgery, Arzt bei HerzZentrum Hirslanden Zürich, Zürich, Switzerland; 31. Cardiology Department, University Hospital Alvaro Cunqueiro, Galicia Sur Health Research Institute, Vigo, Spain

Background: Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation.

Aims: The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices.

Methods: The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC–3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed.

Results: A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p<0.001), resulting in higher VARC-3 intended valve performance (96% vs 90%; p<0.001). Furthermore, more patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%; p<0.001). The reduction in paravalvular AR with neo2 was mainly observed with heavy aortic valve calcification. New pacemaker implantation and VARC-3 technical and device success rates were similar between the 2 groups; there were more frequent vascular and bleeding complications for the neo device. Similar 1-year survival was detected after TAVR (neo2: 90% vs neo: 87%; p=0.14).

Conclusions: TAVR with the ACURATE neo2 device was associated with a lower prevalence of moderate or severe paravalvular AR and more patients with none/trace paravalvular AR. This difference was particularly evident with heavy aortic valve calcification.

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