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Trans Apical Mitral Implantation (TAMI) of the Tiara ? Bio-prosthesis: Pre-Clinical Results #MMPMID24556094
Banai S; Verheye S; Cheung A; Schwartz M; Marko A; Lane R; Jolicoeur EM; Garceau P; Biner S; Tanguay JF; Edelman ER; White CJ
JACC Cardiovasc Interv 2014[Feb]; 7 (2): 154-62 PMID24556094show ga
Objectives: To describe the pre-clinical evaluation of Trans-Apical Mitral Implantation (TAMI) of the Tiara in preparation for first-in-man implantation. Background: The Tiara? is a trans-catheter self-expanding mitral bio-prosthesis, specifically designed for the complex anatomical configuration of the mitral apparatus. Methods: Tiara valves were implanted in an acute porcine model, in a chronic ovine model, and in human cadavers. Results: Acute and chronic evaluation demonstrated excellent function and alignment of the valves, with no left ventricular outflow tract (LVOT) obstruction, coronary artery obstruction, or transvalvular gradients. Chronic evaluation of 7 sheep demonstrated clinically stable animals. A mild degree of prosthetic valve regurgitation was seen in 2 of the 7 sheep. 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 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 trans-catheter mitral valve implantation we report the successful pre-clinical evaluation of the Tiara trans-catheter self-expanding mitral bioprosthetic valve. In porcine and ovine models without mitral regurgitation, trans-apical mitral implantation of the Tiara valve is technically feasible, safe, and results in a stable and well-functioning mitral bioprosthesis.
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JACC+Cardiovasc+Interv 2014 ; 7 (2): 154-62
