Clinical research

DOI: 10.4244/EIJ-D-22-00914

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

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

Abstract

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...

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Volume 19 Number 1
May 12, 2023
Volume 19 Number 1
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