| Objective: To develop a novel regulable sutureless aortic arch prosthesis that can be used to accomplish aortic arch surgery rapidly, conveniently and safely. Methods: (1) Based on the data from CE-MRA, we reconstructed 3-dimensional solid model of aortic arch utilizing 3D-DOCTOR and Pro/ENGINEER software, analyzed stress of aortic arch wall under pulsatile blood flow condition by means of computational loose coupling fluid-structure interaction using FEM method. (2) We designed and trial-manufactured a novel regulable sutureless aortic arch prosthesis utilizing NiTiNOL stent coated with ePTFE film. The diametral regulability, radial resistive force and adherence to the vessel wall were tested ex vivo. (3) We evaluated the histocompatibility of the ePTFE. (4) We performed aortic arch operation utilizing the new prosthesis by external ligature without any conventional suture in the swine model, and evaluated reliability of anastomosis and surgical practicality. Results: (1) Three-dimensional solid model of aortic arch identical with their anatomical structure was reconstructed successfully and stress analysis of aortic arch wall under pulsatile blood flow condition was performed with striking results, which demonstrated that different position and lamella of aortic arch wall bore different stress in the cardiac cycle. (2) We manufactured the novel regulable sutureless aortic arch prosthesis. The ex vivo tests indicated that the new prosthesis presented with acceptable diametral regulability, radial resistive force and adherence to the vessel wall. (3) The ePTFE showed little cytotoxicity and exellent histocompatibility. (4) The in vivo swine experiments proved that the new prosthesis could meet the requirement of aortic arch surgery and showed satisfying reliability of anastomosis and surgical practicality. Conclusions: The new aortic arch prosthesis demonstrated satisfying reliability of anastomosis, surgical practicality and favorably clinical prospects.
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