Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study
Won‐Keun Kim, Helge Möllmann, Matteo Montorfano, Julia Ellert‐Gregersen, Tanja K. Rudolph, Nicolas M. Van Mieghem, Michael Hilker, Ignacio J. Amat‐Santos, Christian Juhl Terkelsen, Anna Sonia Petronio, Pieter R. Stella, Matthias Götberg, Andreas Rück, Albert Markus Kasel, Ramiro Trillo, Clare Appleby, Marco Barbanti, Philipp Blanke, Federico M. Asch, Rodrigo Modolo, Dominic J. Allocco, Corrado Tamburino
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: 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).