• Georg Nickenig, Christoph Hammerstingl, Robert Schueler, Yan Topilsky, Paul A Grayburn, Alec Vahanian, David Messika-Zeitoun, Marina Urena Alcazar, Stephan Baldus, Rudolph Volker, Michael Huntgeburth, Ottavio Alfieri, Azeem Latib, Giovanni La Canna, Eustachio Agricola, Antonio Colombo, Karl-Heinz Kuck, Felix Kreidel, Christian Frerker, Felix C Tanner, Ori Ben-Yehuda, and Francesco Maisano.
• Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany. Electronic address: georg.nickenig@ukb.uni-bonn.de.
• JACC Cardiovasc Interv. 2016 Oct 10; 9 (19): 2039-2047.

ObjectivesThis study sought to show safety and efficacy of the Cardioband system during 6 months after treatment.BackgroundCurrent 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.MethodsThirty-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.ResultsProcedural 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 was 5% 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).ConclusionsIn 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).Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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