Universität zu Köln

Schaefer, Ulrich, Kempfert, Joerg, Verheye, Stefan, Maisano, Francesco ORCID: 0000-0002-3691-1709, Thiele, Holger ORCID: 0000-0002-0169-998X, Landt, Martin, Haude, Michael, Rudolph, Tanja K., Ince, Hueseyin, Kische, Stephan, Treede, Hendrik, Tonino, Pim and Conradi, Lenard (2020). Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve The BIOVALVE Trials. JACC-Cardiovasc. Interv., 13 (2). S. 157 - 167. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1876-7605

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Abstract

OBJECTIVES The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve. BACKGROUND Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium. METHODS BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol. RESULTS Patients' mean age was 82.4 +/- 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage >= 3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient (1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 +/- 0.4 cm(2) and 1.9 +/- 0.5 cm(2), and mean gradient was 6.4 mm Hg at 30 days and 6 months. CONCLUSIONS Clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis. (C) 2020 Published by Elsevier on behalf of the American College of Cardiology Foundation.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schaefer, Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Kempfert, Joerg UNSPECIFIED UNSPECIFIED UNSPECIFIED Verheye, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Maisano, Francesco UNSPECIFIED orcid.org/0000-0002-3691-1709 UNSPECIFIED Thiele, Holger UNSPECIFIED orcid.org/0000-0002-0169-998X UNSPECIFIED Landt, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Haude, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Rudolph, Tanja K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ince, Hueseyin UNSPECIFIED UNSPECIFIED UNSPECIFIED Kische, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Treede, Hendrik UNSPECIFIED UNSPECIFIED UNSPECIFIED Tonino, Pim UNSPECIFIED UNSPECIFIED UNSPECIFIED Conradi, Lenard UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-348244
DOI:	10.1016/j.jcin.2019.07.058
Journal or Publication Title:	JACC-Cardiovasc. Interv.
Volume:	13
Number:	2
Page Range:	S. 157 - 167
Date:	2020
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 HIGH-RISK PATIENTS; CLINICAL-OUTCOMES; MEDTRONIC COREVALVE; EVOLUT R; IMPLANTATION; REPLACEMENT; PROSTHESIS; SYSTEM; STENOSIS Multiple languages Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/34824