Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System.

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).

• Authors: 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
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 9 Issue 19 Pg. 2039-2047 (10 10 2016) ISSN: 1876-7605 [Electronic] United States
• PMID: 27712741 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Topics

• Aged
• Aged, 80 and over
• Cardiac Catheterization (adverse effects, instrumentation)
• Cardiac Catheters
• Chronic Disease
• Echocardiography, Doppler, Color
• Echocardiography, Three-Dimensional
• Echocardiography, Transesophageal
• Equipment Design
• Europe
• Exercise Tolerance
• Feasibility Studies
• Female
• Heart Failure (complications, physiopathology)
• Humans
• Male
• Middle Aged
• Mitral Valve (diagnostic imaging, physiopathology, surgery)
• Mitral Valve Annuloplasty (adverse effects, instrumentation)
• Mitral Valve Insufficiency (complications, diagnostic imaging, physiopathology, surgery)
• Prospective Studies
• Quality of Life
• Recovery of Function
• Severity of Illness Index
• Stroke Volume
• Surveys and Questionnaires
• Time Factors
• Treatment Outcome
• Ventricular Dysfunction, Left (complications, physiopathology)
• Ventricular Function, Left
• Walk Test
• Walking