Kim, Won-Keun and Hengstenberg, Christian and Hilker, Michael and Kerber, Sebastian and Schaefer, Ulrich and Rudolph, Tanja and Linke, Axel and Franz, Norbert and Kuntze, Thomas and Nef, Holger and Kappert, Utz and Zembala, Michael O. and Toggweiler, Stefan and Walther, Thomas and Moellmann, Helge (2018) The SAVI-TF Registry 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients. JACC-CARDIOVASCULAR INTERVENTIONS, 11 (14). pp. 1368-1374. ISSN 1936-8798, 1876-7605
Full text not available from this repository. (Request a copy)Abstract
OBJECTIVES The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. BACKGROUND The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformite Europeene mark in 2014, but only limited clinical data are available so far. METHODS This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. RESULTS Mean patient age was 81.1 +/- 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 +/- 12.5%, 6.6 +/- 7.5%, and 6.0 +/- 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 +/- 0.43 cm(2), mean gradient was 7.3 +/- 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. CONCLUSIONS Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates. (c) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | IMPLANTATION; ACURATE neo; aortic stenosis; TAVR; transcatheter aortic valve replacement; transfemoral |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 12 Feb 2020 14:14 |
| Last Modified: | 12 Feb 2020 14:14 |
| URI: | https://pred.uni-regensburg.de/id/eprint/14214 |
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