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

JACC Cardiovasc Interv. 2016 Oct 10;9(19):2039-2047. doi: 10.1016/j.jcin.2016.07.005.

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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Cardiac Catheters*
  • Chronic Disease
  • Echocardiography, Doppler, Color
  • Echocardiography, Three-Dimensional
  • Echocardiography, Transesophageal
  • Equipment Design
  • Europe
  • Exercise Tolerance
  • Feasibility Studies
  • Female
  • Heart Failure / complications
  • Heart Failure / physiopathology
  • Humans
  • Male
  • Middle Aged
  • Mitral Valve / diagnostic imaging
  • Mitral Valve / physiopathology
  • Mitral Valve / surgery*
  • Mitral Valve Annuloplasty / adverse effects
  • Mitral Valve Annuloplasty / instrumentation*
  • Mitral Valve Insufficiency / complications
  • Mitral Valve Insufficiency / diagnostic imaging
  • Mitral Valve Insufficiency / physiopathology
  • Mitral Valve Insufficiency / 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
  • Ventricular Dysfunction, Left / physiopathology
  • Ventricular Function, Left
  • Walk Test
  • Walking

Associated data

  • ClinicalTrials.gov/NCT01841554