Preclinical Evaluation Of The Tiara Transapical Mitral Valve Replacement Device
Anson Cheung1, Stefan Verheye2, Randy Lane3, Shmuel Banai4.
1St. Paul's Hospital, Vancouver, BC, Canada, 2ZNA Middelheim Hospital, Antwerp, Belgium, 3Neovasc Inc, Richmond, BC, Canada, 4Tel Aviv Medical Cent e, Tel Aviv, Israel.
Objectives: Preclinical evaluations of the Tiara™ transapical mitral valve replacement device
Background: The Tiara™ transapical mitral valve replacement device is a Nitinol based, self-expandable mitral bovine pericardial valve prosthesis. This bioprosthesis is designed to fit the native mitral valve anatomically. Its unique anchoring mechanisms allow secure fixation to the mitral valve structures.
Methods: Acute and chronic implantations were carried out in a sheep model. Pressurized cadaveric hearts were used in human study. In animal studies, all implants were performed off-pump via the left ventricular apex under fluoroscopic and echocardiographic guidance.
Results: Successful implants were performed in sheep models. Fluoroscopic and echocardiographic guidance allows accurate anatomical deployment. Greater than 150 acute implants were performed with good results. Seven chronic sheep implants (>150 days) evaluation demonstrated excellent prosthetic valve function and hemodynamics. No left ventricular outflow tract or coronary obstruction was observed. Mild paravalvular regurgitation in 2/7 animals. Mean transvalvular gradient was 2mmHg.
Implantation of the Tiara valves in pressurized human cadaver hearts demonstrated proper anatomic alignment and seating of the valve in the left atrium and left ventricle.
Conclusions: Preclinical transcatheter transapical implantation of the Tiara self-expanding mitral bioprosthetic valve is technical feasible. In the acute and chronic ovine model, anatomical implantation with excellent post-implant prosthetic functions and hemodynamics were achieved. Cadaveric human implants further confirmed the feasibility of this novel device.
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