title: Percutaneous repair of the tricuspid valve using a novel cinching device: acute and chronic experience in a preclinical large animal model.
abstract: OBJECTIVE
  The aim of this study was to evaluate the safety, technical feasibility and performance of a new trans-catheter tricuspid repair system.
  
  
  RESULTS
  Thirty-one adult swine underwent implantation of a transcatheter tricuspid remodelling system under general anaesthesia. The steerable transcatheter device was introduced through a 24 Fr femoral sheath into the right femoral vein and delivered to the tricuspid annulus on the beating heart. A fixation element was implanted into the tricuspid annulus. Following implantation, a second delivery system was used to couple the fixation element with a self-expanding nitinol stent. The device was tensioned to reshape the tricuspid valve and increase the coaptation length of the valve leaflets under echo guidance. Finally, the stent was deployed in the inferior vena cava (IVC) to maintain the tension applied. The transcatheter device was successfully implanted in all animals (n=31). Doppler echocardiography prior to sacrifice showed that tricuspid valve function was stable and normal tricuspid leaflet motion was observed. Cinching of the tricuspid annulus resulted in an increase of leaflet coaptation length of 70% (4.5±0.7 mm to 7.78±1.3 mm), an increase in trans-tricuspid peak velocity of 79% (0.38±0.1 m/s to 0.68±0.1 m/s), and a reduction in septolateral tricuspid valve dimension of 30% (35.2±5 mm to 24.8±5 mm). At necropsy, the fixation element was firmly attached to the annulus within a fibrotic tissue, with no coronary lesions observed and no abnormality visible. The stent was fully deployed in the IVC, without displacement or change in the stent shape.
  
  
  CONCLUSIONS
  Percutaneous beating heart remodelling of the tricuspid annulus with a cinching device is safe and feasible.
authors.affiliation: University Hospital of Zurich, Zurich, Switzerland.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Taramasso
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Paolo
authors.initials: P
authors.lastname: Denti
authors.forename: Fabian
authors.initials: F
authors.lastname: Nietlispach
authors.forename: Kevin
authors.initials: K
authors.lastname: Lynn
authors.forename: Nikola
authors.initials: N
authors.lastname: Cesarovic
authors.forename: Alessandro
authors.initials: A
authors.lastname: Addis
authors.forename: Maximilian Y
authors.initials: MY
authors.lastname: Emmert
authors.forename: Andrea
authors.initials: A
authors.lastname: Guidotti
authors.forename: Hugo
authors.initials: H
authors.lastname: Vanermen
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
mesh_terms: D000818:Animals; D058385:Cardiac Valve Annuloplasty / Q000295:instrumentation* / Q000379:methods; D057510:Endovascular Procedures / Q000295:instrumentation*; D005240:Feasibility Studies; D013552:Swine; D014261:Tricuspid Valve / Q000601:surgery*