Interventions for valvular disease and heart failure

Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study

EuroIntervention 2023;19:83-92. DOI: 10.4244/EIJ-D-22-00914

Won-Keun Kim
Won-Keun Kim1, MD; Corrado Tamburino2, MD, PhD; Helge Möllmann3, MD; Matteo Montorfano4, MD; Julia Ellert-Gregersen5, MD; Tanja K. Rudolph6, MD; Nicolas M. Van Mieghem7, MD, PhD; Michael Hilker8, MD; Ignacio J. Amat-Santos9, MD, PhD; Christian Juhl Terkelsen10, MD, DMSc; Anna Sonia Petronio11, MD; Pieter R. Stella12, MD, PhD; Matthias Götberg13, MD, PhD; Andreas Rück14, MD, PhD; A. Markus Kasel15, MD; Ramiro Trillo16, MD; Clare Appleby17, MBChB, PhD; Marco Barbanti2, MD; Philipp Blanke18, MD; Rodrigo Modolo19, MD, PhD; Dominic J. Allocco19, MD; Lars Sondergaard20, MD, DMSc
1. Kerckhoff-Klinik GmbH, Bad Nauheim, Germany; 2. Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico-San Marco, Catania, Italy; 3. St. Johannes Hospital Dortmund, Dortmund, Germany; 4. Interventional Cardiology Unit IRCCS San Raffaele Scientific Institute, Milan, Italy; 5. Department of Cardiology, Odense University Hospital, Odense, Denmark; 6. Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany; 7. Erasmus Medical Center, Rotterdam, the Netherlands; 8. Universitätsklinik Regensburg, Regensburg, Germany; 9. Hospital Clínico Universitario de Valladolid, Valladolid, Spain; 10. Aarhus University Hospital, Aarhus, Denmark; 11. Azienda Ospedaliero Universitaria Pisana, Pisa, Italy; 12. University Medical Center Utrecht, Utrecht, the Netherlands; 13. Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden; 14. Karolinska University Hospital, Stockholm, Sweden; 15. Universitätsspital Zürich, Zürich, Switzerland; 16. Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain and Centro de Investigación Biomedica en Red Enfermedades Cardiovasculares, Madrid, Spain; 17. Liverpool Heart and Chest Hospital, Liverpool, UK; 18. Department of Radiology, St Paul's Hospital & University of British Columbia, Vancouver, BC, Canada; 19. Boston Scientific Corporation, Marlborough, MA, USA; 20. The Heart Center, Rigshospitalet, Copenhagen, Demark

Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device.

Aims: We sought to collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS).

Methods: The ACURATE neo2 Post-Market Clinical Follow-up (PMCF) Study is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30 days. The primary imaging endpoint was hypoattenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included Valve Academic Research Consortium safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography.

Results: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean Society of Thoracic Surgeons score: 2.9±2.0%); 246 patients (98.4%) were successfully treated with the ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%.

Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice.

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