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Transcatheter Pulmonary Heart Valve With Regenerative True™ Tissue
Zeeshan Syedain.
Vascudyne Inc, St Paul, MN, USA.

Objective: Congenital defects of the valve, predominantly in the pulmonary position, require multiple replacement as current bioprosthetic and homograft valves degenerate and calcify over time. A novel regenerative engineered tissue with improved durability without calcification would provide an ideal solution for young patients. Methods: We developed a regenerative engineered tissue in the lab by growing fibroblast in 3D fibrin scaffold. The tissue was evaluated for tensile and suture strength in comparison to porcine pericardium. The tissue was stitched into a nitinol stent to create a transcatheter valve that was evaluated for hydrodynamic performance. Further the engineered tissue valve was evaluated for durability testing in an accelerated wear tester. Engineered tissue and pericardium control valves were subsequently implanted in the juvenile ovine model. The explanted valves were evaluated for tissue tensile properties and histopathology. Results: The engineered tissue had tensile strength at 123% of porcine pericardium. The suture strength of tissue was 394±42grams in comparison to 270±43grams for pericardium. The valve met the ISO standards for hydrodynamic performance (Fig.1a)) with crimped for 18F delivery (Fig.1b). The identical design of engineered tissue valve had 17% great EOA in comparison to porcine pericardium. 6-month explant showed engineered tissue with no evidence of calcification, or fibrotic thickening (Fig.1d). Pericardium valve showed fibrotic thickening (Fig1.c). Histological assessment showed cellular infiltration (Fig.1e) and tensile testing showed no deterioration after 6mo implant. Conclusions: We have successfully developed engineered tissue with tensile and suture strength comparable to the porcine pericardium, which is current material of choice for valve leaflets. The hydrodynamic testing demonstrated 17% improved effective orifice area. This led to improved in vivo performance. Lack of calcification and fibrotic response on engineered tissue in comparison to pericardium provides promising new material for developing future heart valves. .


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