Universität zu Köln

Mollmann, Helge, Walther, Thomas, Siqueira, Dimytri, Diemert, Patrick, Treede, Hendrik, Grube, Eberhard, Nickenig, Georg, Baldus, Stephan, Rudolph, Tanja, Kuratani, Toru, Sawa, Yoshiki, Kempfert, Joerg, Kim, Won-Kcun and Abizaid, Alexandre (2017). Transfemoral TAVI using the self-expanding ACURATE neo prosthesis: one-year outcomes of the multicentre CE-approval cohort. EuroIntervention, 13 (9). S. 1040 - 1047. TOULOUSE CEDEX 6: EUROPA EDITION. ISSN 1969-6213

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Abstract

Aims: The aim of this study was to assess the safety and performance of the ACURATE neo transcatheter heart valve and its transfemoral delivery system. Methods and results: The prospective, multicentre CE-approval cohort consists of a prospective series of the first 89 patients implanted with the ACURATE neo prosthesis. The primary endpoint was all-cause mortality at 30 days. Mean patient age was 83.7 +/- 4.4 years and logistic EuroSCORE I was 26.5 +/- 7.7%. Procedural success was obtained in 84 patients (94.4%). At 30 days, three patients had died, and two major strokes and one reintervention for a ventricular septal defect occurred, leading to a major adverse cardiac and cerebrovascular event (MACCE) rate of 6.7%. Eight patients (10.3%) received a permanent pacemaker. At one year, 20 patients (22.5%) had died and the MACCE rate was 27%. Effective orifice area was 1.76 +/- 0.34 cm(2), and mean gradient 7.5 +/- 2.8 mmHg Only three patients (4.5%) had moderate paravalvular regurgitation. NYHA Class III/IV was present in 94.4% of patients at baseline, in 9.9% at 30 days and in 4.5% at one year post procedure. Conclusions: This first-in-human experience with a novel self-expanding heart valve showed low rates of procedural mortality, major stroke and pacemaker implantation, and good performance outcomes.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mollmann, Helge UNSPECIFIED UNSPECIFIED UNSPECIFIED Walther, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Siqueira, Dimytri UNSPECIFIED UNSPECIFIED UNSPECIFIED Diemert, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED Treede, Hendrik UNSPECIFIED UNSPECIFIED UNSPECIFIED Grube, Eberhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Nickenig, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Baldus, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Rudolph, Tanja UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuratani, Toru UNSPECIFIED UNSPECIFIED UNSPECIFIED Sawa, Yoshiki UNSPECIFIED UNSPECIFIED UNSPECIFIED Kempfert, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Kim, Won-Kcun UNSPECIFIED UNSPECIFIED UNSPECIFIED Abizaid, Alexandre UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-215361
Journal or Publication Title:	EuroIntervention
Volume:	13
Number:	9
Page Range:	S. 1040 - 1047
Date:	2017
Publisher:	EUROPA EDITION
Place of Publication:	TOULOUSE CEDEX 6
ISSN:	1969-6213
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TRANSCATHETER AORTIC-VALVE; ACADEMIC RESEARCH CONSORTIUM; MEDICAL PORTICO VALVE; HIGH-RISK PATIENTS; 1ST-IN-HUMAN EXPERIENCE; CLINICAL-OUTCOMES; IMPLANTATION; REPLACEMENT; STENOSIS; SYSTEM Multiple languages Cardiac & Cardiovascular Systems Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/21536