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:
CreatorsEmailORCIDORCID Put Code
Nickenig, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hammerstingl, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schueler, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Topilsky, YanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grayburn, Paul A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vahanian, AlecUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Messika-Zeitoun, DavidUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alcazar, Marina UrenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baldus, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Volker, RudolphUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huntgeburth, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alfieri, OttavioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Latib, AzeemUNSPECIFIEDorcid.org/0000-0001-9035-343XUNSPECIFIED
La Canna, GiovanniUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Agricola, EustachioUNSPECIFIEDorcid.org/0000-0002-4834-2187UNSPECIFIED
Colombo, AntonioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuck, Karl-HeinzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreidel, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Frerker, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tanner, Felix C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ben-Yehuda, OriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maisano, FrancescoUNSPECIFIEDorcid.org/0000-0002-3691-1709UNSPECIFIED
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:
KeywordsLanguage
TO-EDGE REPAIR; HEART-FAILURE; VALVE; ASSOCIATION; PROGNOSIS; DISEASEMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/25849

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