Universität zu Köln

Nickenig, Georg, Hammerstingl, Christoph, Schueler, Robert, Topilsky, Yan, Grayburn, Paul A., Vahanian, Alec, Messika-Zeitoun, David, Alcazar, Marina Urena, Baldus, Stephan, Volker, Rudolph, Huntgeburth, Michael, Alfieri, Ottavio, Latib, Azeem ORCID: 0000-0001-9035-343X, La Canna, Giovanni, Agricola, Eustachio ORCID: 0000-0002-4834-2187, Colombo, Antonio, Kuck, Karl-Heinz, Kreidel, Felix, Frerker, Christian, Tanner, Felix C., Ben-Yehuda, Ori and Maisano, Francesco ORCID: 0000-0002-3691-1709 (2016). Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation 6-Month Results With the Cardioband Percutaneous Mitral Repair System. JACC-Cardiovasc. Interv., 9 (19). S. 2039 - 2048. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1876-7605

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Abstract

OBJECTIVES This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment. BACKGROUND Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device. METHODS Thirty-one patients (71.8 +/- 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 +/- 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 +/- 11%) were prospectively enrolled. RESULTS Procedural success rate, defined as delivery of the entire device, was 100%. There were no periprocedural deaths (0%), and mortality rate at 1 month or prior to hospital discharge and at 7 months was5% and 9.7% respectively. Cinching of the implanted Cardioband reduced the annular septolateral dimension by >30% from 3.7 +/- 0.5 cm at baseline to 2.5 +/- 0.4 cm after 1 month and to 2.4 +/- 0.4 cm after 6 months, respectively (p<0.001). Percentage of patients with FMR >= 3 was reduced from 77.4% to 10.7% 1 month after the procedure (p < 0.001) and 13.6% (p < 0.001) at 7 months. Percentage of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2% after 7 months (p<0.001); exercise capacity as assessed by 6-min walking test increased from 250 +/- 107 m to 332 +/- 118 m (p<0.001) and quality of life (Minnesota Living With Heart Failure Questionnaire) was also significantly improved (p < 0.001). CONCLUSIONS In this feasibility trial in symptomatic patients with FMR, transcatheter mitral annuloplasty with the Cardioband was effective in reducing MR and was associated with improvement in heart failure symptoms and demonstrated a favorable safety profile. (Cardioband With Transfemoral Delivery System; NCT01841554) (C) 2016 by the American College of Cardiology Foundation.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Nickenig, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Hammerstingl, Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Schueler, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Topilsky, Yan UNSPECIFIED UNSPECIFIED UNSPECIFIED Grayburn, Paul A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vahanian, Alec UNSPECIFIED UNSPECIFIED UNSPECIFIED Messika-Zeitoun, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Alcazar, Marina Urena UNSPECIFIED UNSPECIFIED UNSPECIFIED Baldus, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Volker, Rudolph UNSPECIFIED UNSPECIFIED UNSPECIFIED Huntgeburth, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Alfieri, Ottavio UNSPECIFIED UNSPECIFIED UNSPECIFIED Latib, Azeem UNSPECIFIED orcid.org/0000-0001-9035-343X UNSPECIFIED La Canna, Giovanni UNSPECIFIED UNSPECIFIED UNSPECIFIED Agricola, Eustachio UNSPECIFIED orcid.org/0000-0002-4834-2187 UNSPECIFIED Colombo, Antonio UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuck, Karl-Heinz UNSPECIFIED UNSPECIFIED UNSPECIFIED Kreidel, Felix UNSPECIFIED UNSPECIFIED UNSPECIFIED Frerker, Christian UNSPECIFIED UNSPECIFIED UNSPECIFIED Tanner, Felix C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ben-Yehuda, Ori UNSPECIFIED UNSPECIFIED UNSPECIFIED Maisano, Francesco UNSPECIFIED orcid.org/0000-0002-3691-1709 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-258499
DOI:	10.1016/j.jcin.2016.07.005
Journal or Publication Title:	JACC-Cardiovasc. Interv.
Volume:	9
Number:	19
Page Range:	S. 2039 - 2048
Date:	2016
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 TO-EDGE REPAIR; HEART-FAILURE; VALVE; ASSOCIATION; PROGNOSIS; DISEASE Multiple languages Cardiac & Cardiovascular Systems Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/25849