Universität zu Köln

Maisano, Francesco ORCID: 0000-0002-3691-1709, Taramasso, Maurizio, Nickenig, Georg, Hammerstingl, Christoph, Vahanian, Alec, Messika-Zeitoun, David, Baldus, Stephan, Huntgeburth, Michael, Alfieri, Ottavio, Colombo, Antonio, La Canna, Giovanni, Agricola, Eustachio ORCID: 0000-0002-4834-2187, Zuber, Michel, Tanner, Felix C., Topilsky, Yan, Kreidel, Felix and Kuck, Karl-Heinz (2016). Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. Eur. Heart J., 37 (10). S. 817 - 826. OXFORD: OXFORD UNIV PRESS. ISSN 1522-9645

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Abstract

Aims Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. Methods and results The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 +/- 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 +/- 4.8 to 29 +/- 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR <= 2+. Conclusions This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Maisano, Francesco UNSPECIFIED orcid.org/0000-0002-3691-1709 UNSPECIFIED Taramasso, Maurizio UNSPECIFIED UNSPECIFIED UNSPECIFIED Nickenig, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Hammerstingl, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Vahanian, Alec UNSPECIFIED UNSPECIFIED UNSPECIFIED Messika-Zeitoun, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Baldus, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Huntgeburth, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Alfieri, Ottavio UNSPECIFIED UNSPECIFIED UNSPECIFIED Colombo, Antonio UNSPECIFIED UNSPECIFIED UNSPECIFIED La Canna, Giovanni UNSPECIFIED UNSPECIFIED UNSPECIFIED Agricola, Eustachio UNSPECIFIED orcid.org/0000-0002-4834-2187 UNSPECIFIED Zuber, Michel UNSPECIFIED UNSPECIFIED UNSPECIFIED Tanner, Felix C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Topilsky, Yan UNSPECIFIED UNSPECIFIED UNSPECIFIED Kreidel, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuck, Karl-Heinz UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-281676
DOI:	10.1093/eurheartj/ehv603
Journal or Publication Title:	Eur. Heart J.
Volume:	37
Number:	10
Page Range:	S. 817 - 826
Date:	2016
Publisher:	OXFORD UNIV PRESS
Place of Publication:	OXFORD
ISSN:	1522-9645
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language REGURGITATION; REPAIR; IMPACT; OUTCOMES; DEVICE; RISK Multiple languages Cardiac & Cardiovascular Systems Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28167