title: Transcatheter Mitral Annuloplasty in Chronic Functional Mitral Regurgitation: 6-Month Results With the Cardioband Percutaneous Mitral Repair System.
abstract: This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.affiliation: Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany. Electronic address: georg.nickenig@ukb.uni-bonn.de.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Hammerstingl
authors.affiliation: Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Schueler
authors.affiliation: The Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.
authors.forename: Yan
authors.initials: Y
authors.lastname: Topilsky
authors.affiliation: Baylor Health, Dallas, Texas.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Grayburn
authors.affiliation: Bichat Claude Bernard Hospital-Paris VII University, Paris, France.
authors.forename: Alec
authors.initials: A
authors.lastname: Vahanian
authors.affiliation: Bichat Claude Bernard Hospital-Paris VII University, Paris, France.
authors.forename: David
authors.initials: D
authors.lastname: Messika-Zeitoun
authors.affiliation: Bichat Claude Bernard Hospital-Paris VII University, Paris, France.
authors.forename: Marina
authors.initials: M
authors.lastname: Urena Alcazar
authors.affiliation: Heart Center, University of Cologne, Cologne, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Baldus
authors.affiliation: Heart Center, University of Cologne, Cologne, Germany.
authors.forename: Rudolph
authors.initials: R
authors.lastname: Volker
authors.affiliation: Heart Center, University of Cologne, Cologne, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Huntgeburth
authors.affiliation: San Raffaele University Hospital, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.affiliation: San Raffaele University Hospital, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: San Raffaele University Hospital, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: La Canna
authors.affiliation: San Raffaele University Hospital, Milan, Italy.
authors.forename: Eustachio
authors.initials: E
authors.lastname: Agricola
authors.affiliation: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany.
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Kreidel
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Frerker
authors.affiliation: Valve Clinic, University Heart Center, University Hospital Zürich, Zürich, Switzerland.
authors.forename: Felix C
authors.initials: FC
authors.lastname: Tanner
authors.affiliation: Cardiovascular Research Foundation and Columbia University, New York, New York.
authors.forename: Ori
authors.initials: O
authors.lastname: Ben-Yehuda
authors.affiliation: Valve Clinic, University Heart Center, University Hospital Zürich, Zürich, Switzerland.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D062906:Cardiac Catheters; D002908:Chronic Disease; D018618:Echocardiography, Doppler, Color; D019560:Echocardiography, Three-Dimensional; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005060:Europe; D017079:Exercise Tolerance; D005240:Feasibility Studies; D005260:Female; D006333:Heart Failure / Q000150:complications / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D058386:Mitral Valve Annuloplasty / Q000009:adverse effects / Q000295:instrumentation*; D008944:Mitral Valve Insufficiency / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012720:Severity of Illness Index; D013318:Stroke Volume; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000150:complications / Q000503:physiopathology; D016277:Ventricular Function, Left; D000070857:Walk Test; D016138:Walking
keywords: direct annuloplasty; functional mitral regurgitation; heart failure; transcatheter mitral repair