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One year Results of Aortic Valve Reconstruction Using an In body Tissue Architecture Goat Model
Keitaro Okamoto1, Takayuki Kawashima1, Kyouhei Hatori1, Tomoyuki Wada1, Takeshi Terazawa2, Tadashi Umeno1, Takashi Shuto1, Hirofumi Anai1, Yasuhide Nakayama2, Shinji Miyamoto1.
1Oita University, Oita, Japan, 2Biotube Co., Ltd., Tokyo, Japan.

OBJECTIVE:Autologous pericardium is a widely used plastic material for intracardiac structures, pulmonary arteries, and aortic valve leaflets. In aortic valve neocuspitizations (AVNeo: Ozaki Procedure), which have achieved excellent clinical results for over 10 years, autologous pericardium is used after glutaraldehyde fixation. In-body tissue architecture (IBTA) based on the foreign material tissue encapsulation phenomenon can be used to prepare autologous prosthetic tissues. This study aimed to develop a new leaflet material for AVNeo using IBTA in a goat model.
METHODS: The biosheets were prepared by embedding molds in the dorsal subcutaneous spaces of goats for two months, subsequently isolated as autologous connective tissue with collagen and fibroblasts. AVNeo was performed using biosheets or glutaraldehyde-treated autologous pericardium as a control.RESULTS:In the biosheet model, postoperative echocardiography showed smooth leaflet movement with little regurgitation, similar to that in the autologous pericardium model. Three months after biosheet implantation, the valve leaflets were smooth and covered partially with a thin neointima. In the autologous pericardium model, the pericardial tissue remained, and the numbers of αSMA positive cells increased around the tissue. In the biosheet model, the tissue fused to the annulus, with invasion by αSMA positive cells. Six months later, the biosheet model showed further αSMA positive cell infiltration towards the leaflet, with new elastic fibers at the left ventricular side and endothelial cells at the surface, similar in phenotype to that of native valves. One year later, the biosheet model showed nearly identical αSMA positive cell reactivity and less granulation than the six-month models. There were no calcifications. CONCLUSIONS:Biosheet reactions differed from those of the autologous pericardium, and biosheets may be useful as new aortic valve reconstruction materials.


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