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Transapical Aortic Implantation Of Transcatheter Tissue Engineered Heart Valves Using A Self-expanding Anatomically Orienting System
Maximilian Y. Emmert, Benedikt Weber, Volkmar Falk, Simon P. Hoerstrup.
University of Zurich, Zurich, Switzerland.

OBJECTIVE: Although transcatheter aortic-valve implantation (TAVI) has proven to be a valid alternative for the treatment of aortic valve disease in high-risk patients, the currently utilized prostheses are well known to present with structural degeneration over time. The concept of tissue-engineered heart-valves (TEHV) with remodelling and repair capacities has been suggested as a promising alternative to overcome these limitations. Here we report our initial experience to merge the concept of TEHV with transapical, anatomically orienting delivery system.
METHODS: Tri-leaflet TEHV fabricated from biodegradable synthetic-scaffolds were sewn onto self-expanding nitinol stents before they were seeded with autologous bone marrow derived mononuclear cells. Thereafter, they were transapically implanted into adult sheep using the JenaValve transapical TAVI System (JenaValve, Munich/Germany). The TEHV were assessed with angiography and echocardiography before they were harvested to undergo post mortem analysis.
RESULTS: Anatomically-oriented transapical implantation of bone marrow mononuclear cell derived TEHV into the orthotopic aortic-valve position was successful in all animals. Post implantation angiography and echocardiography demonstrated appropriate positioning in the aortic root fully excluding the native leaflets without any signs of coronary occlusion. The TEHV were competent, had a low mean gradient and displayed intact leaflets well accepting the aortic pressure loading. Minor aortic regurgitation and/or paravalvular leakage was detectable in selected animals. Post-mortem computed tomography confirmed optimal positioning of the TEHV showing the JenaValve stent to be well integrated into the aortic root. Gross examination of the explanted TEHV showed intact leaflets with well identifiable cusps, without any signs of leaflet thickening or shortening.
CONCLUSIONS: In this study we demonstrate the feasibility to merge the concept of TEHV with transapical delivery using a state-of-the-art, anatomically orienting system. These data represent a further milestone towards a translational, transcatheter-based TEHV approach.

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