The Heart Valve Society

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Long-term Follow-up Results After Allogenic Implantation Of In-body Tissue-engineered Heart Valves (bivalves) As A Pulmonary Valve In A Goat Model
Yasuhide Nakayama, Yoshiaki Takewa, Takeshi Terazawa, Eisuke Tatsumi.
National Cerebral and Cardiovascular Center, Osaka, Japan.

BACKGROUND
Our attempted in body tissue architecture technology (IBTA), as a novel and practical regeneration medicine, can prepare completely autologous implantable tissues with various shapes and sizes in molds embedded in the subcutaneous pouches. 3D printer was used in the mold design for several valvular-shaped tissues, including mitral or tricuspid valves. In this study, allogenic implantation of tri-leaflet Biovalve was performed as pulmonary valve in a goat model.
METHODS AND RESULTS
The molds for the tri-leaflet conduit Biovalves were assembled with three plastic parts designed by 3D printer (Projet). Upon removing all the parts from the obtained collagenous tissue containing the mold after its subcutaneous incubation in goats for 2 months, Biovalves with tri-leaflet and conduit (internal diameter: 20 mm) were obtained. Almost all components of the Biovalves were autologous collagen. All surfaces of the Biovalves were very smooth and flat, and leaflet tissues were seamlessly connected with conduit part robustly. In vitro evaluation using a pulsatile circulation circuit showed excellent valvular functions. The Biovalves without any living cells after storing in an alcohol solution were implanted to goats as a pulmonary valve in an allogenic manner. The valve function was maintained for 1.5 year. After extraction, the leaflet tissues were completely covered with endothelial cells. Smooth muscle cells and elastic fiber layers were formed as respective fibrosa or ventricularis layer similar to native three-layered leaflet tissue. In addition, there was no stained with vonkossa, indicating occurrence of no calcification.
CONCLUSION
Autologous pulmonary valular tissue with three layeres could be regenerated on the collagenous Biovalve as a scaffold by implantation for 1.5 year even in an allogenic manner.


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