TY  - JOUR
A1  - Kim, Won-Keun
A1  - Hengstenberg, Christian
A1  - Hilker, Michael
A1  - Kerber, Sebastian
A1  - Schäfer, Ulrich
A1  - Rudolph, Tanja
A1  - Linke, Axel
A1  - Franz, Norbert
A1  - Kuntze, Thomas
A1  - Nef, Holger M.
A1  - Kappert, Utz
A1  - Zembala, Michael O.
A1  - Toggweiler, Stefan
A1  - Walther, Thomas
A1  - Möllmann, Helge
T1  - 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
T2  - JACC Cardiovascular interventions
N2  - 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.
KW  - ACURATE neo
KW  - aortic stenosis
KW  - TAVR
KW  - transcatheter aortic valve replacement
KW  - transfemoral
Y1  - 2018
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/47168
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-471682
SN  - 1876-7605
SN  - 1936-8798
N1  - © 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/)
VL  - 11
IS  - 14
SP  - 1368
EP  - 1374
PB  - Elsevier ; American College of Cardiology
CY  - New York, NY
ER  -