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

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 
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 Conformité Européene 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 cm2, 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.
show moreshow less

Metadaten
Author:Won-Keun Kim, Christian Hengstenberg, Michael Hilker, Sebastian Kerber, Ulrich Schäfer, Tanja Rudolph, Axel Linke, Norbert Franz, Thomas Kuntze, Holger M. Nef, Utz Kappert, Michael O. Zembala, Stefan Toggweiler, Thomas Walther, Helge Möllmann
URN:urn:nbn:de:hebis:30:3-471682
DOI:http://dx.doi.org/10.1016/j.jcin.2018.03.023
ISSN:1876-7605
ISSN:1936-8798
Pubmed Id:http://www.ncbi.nlm.nih.gov/pubmed?term=30025731
Parent Title (English):JACC Cardiovascular interventions
Publisher:Elsevier ; American College of Cardiology
Place of publication:New York, NY
Contributor(s):Beatrix Dörr
Document Type:Article
Language:English
Year of Completion:2018
Date of first Publication:2018/07/16
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2018/09/04
Tag:ACURATE neo; TAVR; aortic stenosis; transcatheter aortic valve replacement; transfemoral
Volume:11
Issue:14
Pagenumber:7
First Page:1368
Last Page:1374
Note:
© 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/)
HeBIS PPN:437852199
Institutes:Medizin
Dewey Decimal Classification:610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung-Nicht kommerziell - Keine Bearbeitung 4.0

$Rev: 11761 $