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Engineered Tissue Transcatheter Valve for Pulmonary and Tricuspid Valve Implant
Zeeshan Syedain.
University of Minnesota, Minneapolis, MN, USA.

OBJECTIVE: Fixed pericardium heart valves demonstrate long-term performance in older patients for left-sided heart treatments but face challenges in right-sided heart treatments and younger patients. Engineered tissue is a viable solution with regenerative capacity to overcome durability concerns and low pressure differential related thrombosis issues.
METHODS: Engineered tissue (ET) was developed using cell produced ECM within a fibrin scaffold then decellularized. Tensile and suture pullout of ET was compared against glutaraldehyde fixed pericardium. ET and pericardium were sewn to nitinol stents designed for pulmonary or venacaval implant then evaluated via pulse duplicator. Ovine model is currently being utilized for in vivo right-sided heart valve evaluation.
RESULTS: The ETV had tensile properties comparable to current standard with suture retention 75% of fixed pericardium. The suture retention of 200 +/- 40 grams was sufficient for valve stitching. Testing showed low regurgitation and systolic pressure drop. An image of the valve in an open/closed position and flow-pressure plots are shown in Fig. 1. The valve was crimped to 18F for delivery, and performance evaluated post-crimp showed no change in the hydrodynamic characterization. Ovine has been established as an in-vivo model with a control valve using an 18F delivery system.
CONCLUSIONS: We have developed a transcatheter engineered tissue valve which has earlier demonstrated regenerative capacity and lack calcification in right-sided heart applications after 1 year in juvenile sheep. In-vitro hydrodynamics showed Engineered Tissue to be more compliant than pericardium, leading to lower closing volume and systolic pressure drops, thus increasing the EOA and all critical parameters for a right-sided heart valve. An ovine model is being utilized for the in vivo regeneration and performance as a pulmonary and venacaval implant.


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