Original Research

DOI: 10.4244/EIJ-D-23-00823

Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-year results of the ACURATE neo2 PMCF Study

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

Abstract

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...

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Volume 20 Number 1
Jan 1, 2024
Volume 20 Number 1
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