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Long Term Evaluation of In-Body Tissue Engineered Heart Valve (Biovalve)
Yoshiaki Takewa.
National Cerebral and Cardiovascular Center, Osaka, Japan.

OBJECTIVE: A novel autologous aortic valve with a metallic stent (Biovalve Stent) was developed, using simple, safe and economical in-body tissue engineering. In this study, the long-term evaluation of the Biovalve Stent for transcatheter implantation was investigated in a goat model.
METHODS: Biovalve Stents were prepared by 2-month embedding of the molds, assembled using plastic rods and a metallic stent, in the subcutaneous spaces of goats. After extracting the molds and removing the plastic rods only, Biovalve Stents with tri-leaflets similar to those of the native aortic valves were constituted from completely autologous connective tissues. Twelve out of 15 Biovalve Stents were implanted in the aorta in situ and other 3 Biovalve Stents were implanted in the pulmonary artery (PA) in situ with transcatheter technique.
RESULTS: In both aortic and PA cases, the Biovalve Stents were successfully implanted. Angiography showed smooth movement of the leaflets with a little regurgitation under the systemic and pulmonary circulation. The Biovalve Stents were extracted 1, 2, 5 or 6 months after implantation. The leaflets of the Biovalve kept their shape and elasticity even after 5 months and neither calcification nor thrombi were observed. Histological examination showed the cell populations inside the valves and endothelial cells covering the laminar surface of the valve leaflets.
CONCLUSIONS: The Biovalve Stent satisfied the higher requirements of systemic and pulmonary circulation in goats for maximum 6 months with the potential for transcatheter implantation.

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