We developed a next-generation α-Gal-free tissue valve with simultaneous use of multiple anticalcification therapies and novel tissue treatments such as decellularization, immunological modification with α-galactosidase, space filler, an organic solvent and detoxification. Future investigations should evaluate α-Gal-free substitutes such as our tissue valve, and a future clinical study is warranted based on these promising preclinical results.
Glutaraldehyde (GA) is largely used in the cross-linking of collagen matrices to improve their mechanical and biological properties for applications in cardiovascular surgery. However, GA has major drawbacks, including graft degeneration, calcification, and durability. The aim of this study was to test the hypothesis that filling the interstitial space in the bovine pericardium with various space fillers could prevent tissue calcification. GA, genipin, and 1-ethyl-3(-3 dimethyl aminopropyl) carbodiimide hydrochloride fixation with spacefiller treatment have been studied in order to improve the properties of heart valve xenografts. Crosslinking efficiency of GA treated group was better than genipin or 1-(3-dimethyl aminopropyl)-3-ethyl carbodiimide/N-hydroxysuccinimide treated group in vitro mechanical, enzymatic degradation resistance tests. Space-filling samples have shown significantly reduced calcification in the rabbit intramuscular implantation model. Regardless of the filling effect, the level of calcification and the cytotoxicity was low in a genipin-treated group compared to levels in the GA-treated group. The results indicated that GA and genipin fixation with space-filler treatment were effective in anticalcification for biological tissue preservation.
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