title: Transcatheter direct mitral annuloplasty with Cardioband: feasibility and efficacy trial in an acute preclinical model.
abstract: OBJECTIVE
  The aim of the study was to report preclinical safety and feasibility of a new transcatheter direct mitral annuloplasty intervention in an acute animal model.
  
  
  RESULTS
  Twenty healthy pigs underwent Cardioband (Valtech Cardio, Or Yehuda, Israel) transcatheter implantation under intracardiac echocardiographic and fluoroscopic guidance. Through a neo inferior vena cava approach, transseptal access was arranged. The device was delivered into the left atrium using a multi-steerable catheter and fixed to the mitral annulus with multiple helix anchors. Following device cinching, reduction of annular size was evaluated. In all animals the device could be successfully implanted and displayed 100% function, with the average procedure duration and fluoroscopy times being 78±23 minutes and 27±9 minutes, respectively. In total, 246 anchors (average 12.3 per device) were delivered and optimal anchor placement was achieved in 95.1%, while inadequate anchor position (4%) and injury of the coronary sinus or atrium (0.8%) occurred in the rest. Following maximal cinching, diastolic transmitral flow velocity and coaptation lengths were markedly increased (p<0.001), whereas septolateral and intercommissural distances were significantly decreased (p<0.001), when compared to pre-contraction baseline, demonstrating efficient annular reduction by the device.
  
  
  CONCLUSIONS
  Transcatheter direct annuloplasty with a surgical-like adjustable device is feasible in the porcine animal model. The humanised porcine model has been instrumental in demonstrating feasibility and in establishing the procedural steps.
authors.affiliation: Clinic of Cardiovascular Surgery, University Hospital Zürich, University of Zürich, Zurich, Switzerland.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Taramasso
authors.forename: Andrea
authors.initials: A
authors.lastname: Guidotti
authors.forename: Nikola
authors.initials: N
authors.lastname: Cesarovic
authors.forename: Paolo
authors.initials: P
authors.lastname: Denti
authors.forename: Alessandro
authors.initials: A
authors.lastname: Addis
authors.forename: Alessandro
authors.initials: A
authors.lastname: Candreva
authors.forename: Fabian
authors.initials: F
authors.lastname: Nietlispach
authors.forename: Thea
authors.initials: T
authors.lastname: Fleischmann
authors.forename: Maximilian Y
authors.initials: MY
authors.lastname: Emmert
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization; D054326:Coronary Sinus / Q000601:surgery; D005260:Female; D006325:Heart Atria / Q000601:surgery*; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D008943:Mitral Valve / Q000503:physiopathology / Q000601:surgery*; D058386:Mitral Valve Annuloplasty / Q000379:methods; D008944:Mitral Valve Insufficiency / Q000503:physiopathology / Q000601:surgery*; D023421:Models, Animal; D013552:Swine