Won-Keun Kim; Helge Möllmann; Matteo Montorfano; Julia Ellert-Gregersen; Tanja  K. Rudolph; Nicolas  M. Van Mieghem; Michael Hilker; Ignacio Amat-Santos; Christian  Juhl Terkelsen; Anna  Sonia Petronio; Pieter Stella; Matthias Götberg; Andreas Rück; A.  Markus Kasel; Ramiro Trillo; Clare Appleby; Marco Barbanti; Philipp Blanke; Federico  M. Asch; Rodrigo Modolo; Dominic  J. Allocco; Corrado Tamburino

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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