title: Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial.
abstract: OBJECTIVE
  Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial.
  
  
  RESULTS
  The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+.
  
  
  CONCLUSIONS
  This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.
authors.affiliation: Klinik für Herz- und Gefässchirurgie, University Hospital of Zurich, University of Zurich, Heart Center, Rämistrasse, 100, 8091 Zurich, Switzerland francesco.maisano@usz.ch.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Klinik für Herz- und Gefässchirurgie, University Hospital of Zurich, University of Zurich, Heart Center, Rämistrasse, 100, 8091 Zurich, Switzerland.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Taramasso
authors.affiliation: Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Hammerstingl
authors.affiliation: Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France.
authors.forename: Alec
authors.initials: A
authors.lastname: Vahanian
authors.affiliation: Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France.
authors.forename: David
authors.initials: D
authors.lastname: Messika-Zeitoun
authors.affiliation: Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Baldus
authors.affiliation: Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Huntgeburth
authors.affiliation: Cardiovascular Department, San Raffaele University Hospital, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.affiliation: Cardiovascular Department, San Raffaele University Hospital, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Cardiovascular Department, San Raffaele University Hospital, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: La Canna
authors.affiliation: Cardiovascular Department, San Raffaele University Hospital, Milan, Italy.
authors.forename: Eustachio
authors.initials: E
authors.lastname: Agricola
authors.affiliation: Klinik für Herz- und Gefässchirurgie, University Hospital of Zurich, University of Zurich, Heart Center, Rämistrasse, 100, 8091 Zurich, Switzerland.
authors.forename: Michel
authors.initials: M
authors.lastname: Zuber
authors.affiliation: Klinik für Herz- und Gefässchirurgie, University Hospital of Zurich, University of Zurich, Heart Center, Rämistrasse, 100, 8091 Zurich, Switzerland.
authors.forename: Felix C
authors.initials: FC
authors.lastname: Tanner
authors.affiliation: The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
authors.forename: Yan
authors.initials: Y
authors.lastname: Topilsky
authors.affiliation: Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Kreidel
authors.affiliation: Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany.
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
mesh_terms: D000368:Aged; D006328:Cardiac Catheterization / Q000379:methods* / Q000401:mortality; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D017052:Hospital Mortality; D006801:Humans; D007430:Intraoperative Care; D008297:Male; D058386:Mitral Valve Annuloplasty / Q000379:methods* / Q000401:mortality; D008944:Mitral Valve Insufficiency / Q000401:mortality / Q000601:surgery*; D061214:Patient Safety; D011446:Prospective Studies; D011474:Prosthesis Design; D016896:Treatment Outcome
keywords: Direct annuloplasty; Secondary mitral regurgitation; Transcatheter mitral repair