Kim, Won-Keun and Tamburino, Corrado and Mollmann, Helge and Montorfano, Matteo and Ellert-Gregersen, Julia and Rudolph, Tanja K. and Van Mieghem, Nicolas M. and Hilker, Michael and Amat-Santos, Ignacio J. and Terkelsen, Christian Juhl and Petronio, Anna Sonia and Stella, Pieter R. and Gotberg, Matthias and Ruck, Andreas and Kasel, A. Markus and Trillo, Ramiro and Appleby, Clare and Barbanti, Marco and Blanke, Philipp and Modolo, Rodrigo and Allocco, Dominic J. and Sondergaard, Lars (2023) Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study. EUROINTERVENTION, 19 (1). 83-ff. ISSN 1774-024X, 1969-6213
Full text not available from this repository. (Request a copy)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 new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6 +/- 14.5 mmHg to 8.6 +/- 3.9 mmHg; mean aortic valve area: from 0.7 +/- 0.2 cm(2) to 1.6 +/- 0.4 cm(2)). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | END-POINT DEFINITIONS; SAPIEN 3 ULTRA; AORTIC-VALVE; 30-DAY OUTCOMES; EVOLUT PRO; REPLACEMENT; IMPLANTATION; PROSTHESIS; aortic stenosis; femoral; MSCT; TAVI; transoesophageal echocardiogram |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 20 Mar 2024 08:48 |
| Last Modified: | 20 Mar 2024 08:48 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60728 |
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