title: Preclinical in vivo long-term evaluation of the novel Mitra-Spacer technology: experimental validation in the ovine model.
abstract: OBJECTIVE
  The Mitra-Spacer (Cardiosolutions, Bridgewater, MA, USA) is designed to treat mitral regurgitation by introducing a dynamic spacer that constantly adapts to the changing haemodynamic conditions during the cardiac cycle. We aimed to evaluate the performance and safety of this device in the chronic ovine model.
  
  
  RESULTS
  Eight sheep were enrolled in this study. Through a left thoracotomy, the Mitra-Spacer was inserted via the transapical approach and advanced into the left atrium (LA) under imaging guidance. Device performance and safety were evaluated up to 90 days using fluoroscopy, echocardiography and histopathology. The volume within the balloon spacer shifted during the cardiac cycle in all cases. Seven animals survived up to 90 days for terminal imaging and tissue harvest. Echocardiography showed no change in left ventricle (LV) ejection fraction from baseline to 90 days. There were no observations of changes in LV diastolic function, pulmonary vein inflow, or tricuspid valve function. Histological analysis demonstrated no significant injury to the mitral apparatus.
  
  
  CONCLUSIONS
  In the healthy ovine model, Mitra-Spacer implantation was feasible and safe. At 90 days, no evidence of structural damage to the mitral apparatus or deterioration of cardiac performance was demonstrated.
authors.affiliation: CRF Skirball Center for Innovation, Cardiovascular Research Foundation, Orangeburg, NY, USA.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Peppas
authors.forename: Ariel
authors.initials: A
authors.lastname: Furer
authors.forename: Jon
authors.initials: J
authors.lastname: Wilson
authors.forename: GengHua
authors.initials: G
authors.lastname: Yi
authors.forename: Yanping
authors.initials: Y
authors.lastname: Cheng
authors.forename: Karl
authors.initials: K
authors.lastname: Van Wygerden
authors.forename: Christopher
authors.initials: C
authors.lastname: Seguin
authors.forename: Masahiko
authors.initials: M
authors.lastname: Shibuya
authors.forename: Grzegorz L
authors.initials: GL
authors.lastname: Kaluza
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization / Q000379:methods; D004452:Echocardiography / Q000379:methods; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006439:Hemodynamics / Q000502:physiology; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D023421:Models, Animal; D012756:Sheep; D013908:Thoracotomy / Q000379:methods; D013995:Time; D016277:Ventricular Function, Left / Q000502:physiology*