title: Transapical mitral implantation of the Tiara bioprosthesis: pre-clinical results.
abstract: OBJECTIVE
  This study sought to describe the pre-clinical evaluation of transapical mitral implantation of the Tiara (Neovasc Inc, Vancouver, British Columbia, Canada) valve in preparation for first-in-man implantation.
  
  
  BACKGROUND
  The Tiara is a transcatheter self-expanding mitral bioprosthesis, specifically designed for the complex anatomic configuration of the mitral apparatus.
  
  
  METHODS
  Tiara valves were implanted in a short-term porcine model, in a long-term ovine model, and in human cadavers.
  
  
  RESULTS
  Short-term and long-term evaluation demonstrated excellent function and alignment of the valves, with no left ventricular outflow tract obstruction, coronary artery obstruction, or transvalvular gradients. Long-term evaluation of 7 sheep demonstrated clinically stable animals. A mild degree of prosthetic valve regurgitation was seen in 2 of the 7 sheep. A mild-to-moderate degree of paravalvular leak, which was attributed to this animal model, was observed in 6 of these animals. Cardioscopy and macroscopic evaluation demonstrated stable and secure positioning of the Tiara valve with no evidence of injury to the ventricular or atrial walls. Pericardial leaflets were free and mobile without calcifications. Implantation of the Tiara valves in human cadaver hearts demonstrated, upon visual inspection, proper anatomic alignment and seating of the valve, both at the atrial and at the ventricular aspects of the native mitral apparatus.
  
  
  CONCLUSIONS
  In preparation for the first-in-man transcatheter mitral valve implantation, we report the successful pre-clinical evaluation of the Tiara transcatheter self-expanding mitral bioprosthetic valve. In porcine and ovine models without mitral regurgitation, transapical mitral implantation of the Tiara valve is technically feasible and safe, and results in a stable and well-functioning mitral bioprosthesis.
authors.affiliation: Cardiology Department, Tel Aviv Medical Center, Tel Aviv, Israel. Electronic address: shmuelb@tlvmc.gov.il.
authors.forename: Shmuel
authors.initials: S
authors.lastname: Banai
authors.affiliation: Cardiology Department, ZNA Middelheim Hospital, Antwerp, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.affiliation: Cardiac Surgery Department, St. Paul's Hospital, Vancouver, British Columbia, Canada.
authors.forename: Anson
authors.initials: A
authors.lastname: Cheung
authors.affiliation: Neovasc Inc., Vancouver, British Columbia, Canada.
authors.forename: Marc
authors.initials: M
authors.lastname: Schwartz
authors.affiliation: Neovasc Inc., Vancouver, British Columbia, Canada.
authors.forename: Alexei
authors.initials: A
authors.lastname: Marko
authors.affiliation: Neovasc Inc., Vancouver, British Columbia, Canada.
authors.forename: Randy
authors.initials: R
authors.lastname: Lane
authors.affiliation: Cardiology Department, Montreal Heart Institute, Montréal, Québec, Canada.
authors.forename: E Marc
authors.initials: EM
authors.lastname: Jolicoeur
authors.affiliation: Cardiology Department, Montreal Heart Institute, Montréal, Québec, Canada.
authors.forename: Patrick
authors.initials: P
authors.lastname: Garceau
authors.affiliation: Cardiology Department, Tel Aviv Medical Center, Tel Aviv, Israel.
authors.forename: Simon
authors.initials: S
authors.lastname: Biner
authors.affiliation: Cardiology Department, Montreal Heart Institute, Montréal, Québec, Canada.
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Tanguay
authors.affiliation: Biomedical Engineering Center, Harvard-MIT, Cambridge, Massachusetts.
authors.forename: Elazer R
authors.initials: ER
authors.lastname: Edelman
authors.affiliation: Cardiology Department, John Ochsner Heart & Vascular Institute Medical Center, New Orleans, Louisiana.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: White
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001705:Bioprosthesis; D002102:Cadaver; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D017023:Coronary Angiography; D019560:Echocardiography, Three-Dimensional; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D008944:Mitral Valve Insufficiency / Q000209:etiology / Q000503:physiopathology; D023421:Models, Animal; D011474:Prosthesis Design; D012756:Sheep; D013552:Swine; D013997:Time Factors
keywords: mitral regurgitation; mitral valve; mitral valve implantation; transapical; transcatheter