Won-Keun Kim1, MD; Helge Möllmann2, MD; Matteo Montorfano3, MD; Julia Ellert-Gregersen4, MD; Tanja K. Rudolph5, MD; Nicolas M. Van Mieghem6, MD, PhD; Michael Hilker7, MD; Ignacio Amat-Santos8, MD, PhD; Christian Juhl Terkelsen9, MD, DMSc; Anna Sonia Petronio10, MD; Pieter Stella11, MD, PhD; Matthias Götberg12, MD, PhD; Andreas Rück13, MD, PhD; A. Markus Kasel14, MD; Ramiro Trillo15, MD; Clare Appleby16, MBChB, PhD; Marco Barbanti17, MD; Philipp Blanke18, MD; Federico M. Asch19, MD; Rodrigo Modolo20, MD, PhD; Dominic J. Allocco20, MD; Corrado Tamburino21, MD, PhD
1. Kerckhoff-Klinik GmbH, Bad Nauheim, Germany; 2. St.-Johannes-Hospital Dortmund, Dortmund, Germany; 3. School of Medicine, Vita-Salute San Raffaele University, Milan, Italy and Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; 4. Department of Cardiology, Odense University Hospital, Odense, Denmark; 5. Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany; 6. Erasmus Medical Center, Rotterdam, the Netherlands; 7. Universitätsklinik Regensburg, Regensburg, Germany; 8. Hospital Clínico Universitario de Valladolid, Valladolid, Spain; 9. Aarhus University Hospital, Aarhus, Denmark; 10. Azienda Ospedaliero Universitaria Pisana, Pisa, Italy; 11. University Medical Center Utrecht, Utrecht, the Netherlands; 12. Department of Cardiology, Skåne University Hospital, Lund University, Lund, Sweden; 13. Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden; 14. Universitätsspital Zürich, Zürich, Switzerland; 15. Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain and Centro de Investigación Biomedica en Red Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain; 16. Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; 17. Università degli Studi di Enna “Kore”, Enna, Italy; 18. Department of Radiology, St Paul’s Hospital & University of British Columbia, Vancouver, BC, Canada; 19. MedStar Health Research Institute, Washington, D.C., USA; 20. Boston Scientific Corporation, Marlborough, MA, USA; 21. Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico G. Rodoloco-San Marco, Catania, Italy
Background: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation.
Aims: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting.
Methods: Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography).
Results: The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL).
Conclusions: The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248)
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