Universität zu Köln

Boergermann, Jochen, Holzhey, David M., Thielmann, Matthias, Girdauskas, Evaldas ORCID: 0000-0003-1571-4244, Schroefel, Holger, Hofmann, Steffen, Treede, Hendrik, Matschke, Klaus, Hilker, Michael, Strauch, Justus T., Carrel, Thierry, Wahlers, Thorsten, Diegeler, Anno, Kempfert, Joerg and Walther, Thomas (2017). Transcatheter aortic valve implantation using the ACURATE TA (TM) system: 1-year outcomes and comparison of 500 patients from the SAVI registries. Eur. J. Cardio-Thorac. Surg., 51 (5). S. 936 - 943. CARY: OXFORD UNIV PRESS INC. ISSN 1873-734X

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Abstract

OBJECTIVES: The ACURATE TA (TM) system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine. METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2. RESULTS: Patients were 80.8 +/- 6.1 years old, the mean logistic EuroSCORE-I was 23.4 +/- 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage >= 2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up. CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TA (TM) device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Boergermann, Jochen UNSPECIFIED UNSPECIFIED UNSPECIFIED Holzhey, David M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Thielmann, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Girdauskas, Evaldas UNSPECIFIED orcid.org/0000-0003-1571-4244 UNSPECIFIED Schroefel, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Hofmann, Steffen UNSPECIFIED UNSPECIFIED UNSPECIFIED Treede, Hendrik UNSPECIFIED UNSPECIFIED UNSPECIFIED Matschke, Klaus UNSPECIFIED UNSPECIFIED UNSPECIFIED Hilker, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Strauch, Justus T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Carrel, Thierry UNSPECIFIED UNSPECIFIED UNSPECIFIED Wahlers, Thorsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Diegeler, Anno UNSPECIFIED UNSPECIFIED UNSPECIFIED Kempfert, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Walther, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-232300
DOI:	10.1093/ejcts/ezw423
Journal or Publication Title:	Eur. J. Cardio-Thorac. Surg.
Volume:	51
Number:	5
Page Range:	S. 936 - 943
Date:	2017
Publisher:	OXFORD UNIV PRESS INC
Place of Publication:	CARY
ISSN:	1873-734X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language HEART-VALVE; TAVI; BIOPROSTHESIS; REGURGITATION; STENOSIS; THERAPY; DEVICES Multiple languages Cardiac & Cardiovascular Systems; Respiratory System; Surgery Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/23230