Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System
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, Francesco Maisano, 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, Francesco Maisano
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 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).
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).
Keywords: direct annuloplasty; functional mitral regurgitation; heart failure; transcatheter mitral repair.
Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed