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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The Early neo2 Registry: Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population
Journal of the American Heart Association, Volume 12, No. 15, Article e029464, Year 2023
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Description
BACKGROUND: ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. METHODS AND RESULTS: The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory–adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. CONCLUSIONS: In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation. © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
Authors & Co-Authors
Rück, Andreas
Sweden, Stockholm
Karolinska Universitetssjukhuset
Kim, Won Keung
Germany, Bad Nauheim
Kerckhoff Heart and Lung Centre
Abdel-Wahab, Mohamed Kader
Germany, Leipzig
Universität Leipzig
Thiele, Holger
Germany, Leipzig
Universität Leipzig
Rudolph, Tanja Katharina
Germany, Bochum
Ruhr-universitat Bochum
Wolf, Alexander
Germany, Essen
Elisabeth-krankenhaus Essen
Søndergaard, Lars
Denmark, Copenhagen
Copenhagen University Hospital
Hengstenberg, Christian
Austria, Vienna
Medizinische Universität Wien
Laine, Mika K.
Finland, Helsinki
Helsinki University Hospital
Bjursten, Henrik
Sweden, Lund
Lunds Universitet
Götberg, Matthias
Sweden, Lund
Lunds Universitet
Pellegrini, Costanza
Germany, Munich
Technische Universität München
Toggweiler, Stefan
Switzerland, Luzern
Kantonsspital Luzern
Wykrzykowska, Joanna J.
Netherlands, Groningen
Rijksuniversiteit Groningen
Soliman, O. I.I.
Ireland, Galway
University of Galway
Saleh, Nawzad
Sweden, Stockholm
Karolinska Universitetssjukhuset
Meduri, Christopher U.
Sweden, Stockholm
Karolinska Universitetssjukhuset
Statistics
Authors: 17
Affiliations: 13
Identifiers
Doi:
10.1161/JAHA.122.029464
ISSN:
20479980
Research Areas
Health System And Policy
Noncommunicable Diseases
Violence And Injury
Study Design
Cross Sectional Study
Participants Gender
Female