Development of completely autologous aortic valves by a novel concept of regenerative medicine

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A 3D printer, which can easily reproduce the 3D-shape and size of native heart valves, was used to produce the molds for a tri-leaflet, valved conduit with a sinus of Valsalva. Biovalves were obtained from completely autologous connective tissue, containing collagen and fibroblasts, within 2 months following the subcutaneous embedding of the molds. In vitro evaluation, using a pulsatile circulation circuit, showed excellent valvular function with a durability of at least 10 days. The Biovalves were implanted in goats through an apicoaortic bypass procedure. Smooth movement of the leaflets with minimal regurgitation were observed. After 1 month of implantation, smooth white leaflets were observed with minimal thrombus formation. Functional, autologous, 3D-shaped heart valves with clinical application potential were formed following in-body embedding of specially designed molds.