Universität zu Köln

Kim, Won-Keun, Hengstenberg, Christian, Hilker, Michael, Kerber, Sebastian, Schaefer, Ulrich, Rudolph, Tanja, Linke, Axel, Franz, Norbert, Kuntze, Thomas, Nef, Holger, Kappert, Utz, Zembala, Michael O., Toggweiler, Stefan, 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-Cardiovasc. Interv., 11 (14). S. 1368 - 1375. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1876-7605

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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:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kim, Won-Keun UNSPECIFIED UNSPECIFIED UNSPECIFIED Hengstenberg, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Hilker, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Kerber, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Schaefer, Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Rudolph, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Linke, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Franz, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuntze, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Nef, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Kappert, Utz UNSPECIFIED UNSPECIFIED UNSPECIFIED Zembala, Michael O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Toggweiler, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Walther, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Moellmann, Helge UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-179551
DOI:	10.1016/j.jcin.2018.03.023
Journal or Publication Title:	JACC-Cardiovasc. Interv.
Volume:	11
Number:	14
Page Range:	S. 1368 - 1375
Date:	2018
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1876-7605
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language IMPLANTATION Multiple languages Cardiac & Cardiovascular Systems Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/17955