Animal Experiment And Clinical Application Research Of A Single Inner Branched Thoracic Aortic Stent Graft System

Purpose:Chapter 1:Evaluate the safety and feasibility of the application of a single inner branched thoracic aortic stent graft system through animal experiments and explore and formulate the operation process of this device.Chapter 2:Evaluate the safety and effectiveness of single inner branched thoracic aortic stent graft in the treatment of TBAD adjacent to LSA by analyzing the results of prospective,multicenter clinical trial.Chapter 3:Analyze the hemodynamic changes before and after the implantation of the single inner branched thoracic aortic stent graft by the method of computational fluid dynamics.Methods:Chapter 1:Fourteen experimental pigs were included.The main stent graft was introduced through the right femoral artery and released in the ideal position.The branch stent graft was introduced through the right carotid artery and released in the ideal position.The imaging data of experimental pigs were collected at 30,90 and 180 days after operation.Then the experimental pigs were euthanized,and tissue samples were harvested.Evaluate the safety and feasibility of the device by analyzing the intraoperative and postoperative data.Chapter 2:Evaluate the safety and effectiveness of single inner branched thoracic aortic stent graft in the treatment of TBAD adjacent to LSA by analyzing the patient data of perioperative,1 month and 6 months after operation in this prospective,multicenter clinical trial.Chapter 3:The data of preoperative and postoperative pressure,wall shear stress and flow field distribution were obtained by means of computational fluid dynamics.Then the hemodynamic changes of patients before and after implantation of the device were analyzed.Results:Chapter 1:The technical success rate was 100%.During the follow-up period,all surviving experimental pigs had good diet and activities.Imaging data showed that all stent grafts were complete without obvious endoleaks,and the branch stent grafts were patent.Histological examination showed that the biocompatibility of this device was good.Chapter 2:The immediate technical success rate was 99.2%.At 1 month follow-up,the all-cause mortality was 0.83%,the endoleak rate was 0.83%,and the reintervention rate was 2.48%.At 6-month follow-up,aortic remodeling was good,no new endoleak or new reintervention was found,and 1 branch stent graft occlusion was found.Chapter 3:The pressure and wall shear stress are greatly affected by the shape of the lesion,and the change trend before and after operation is not consistent.The streamline after operation was more stable than that before operation,and the turbulence and eddy current were reduced.The retrograde branch stent graft could ensure the blood perfusion of LSA;Single inner branched thoracic aortic stent graft is effective in the treatment of TBAD adjacent to LSA,and the aortic remodeling was good 6 months after operation.Conclusions:The early safety and effectiveness of the single inner branched thoracic aortic stent graft for the treatment of TBAD adjacent to LSA was good.Its long-term safety and effectiveness still need to be evaluated by longer follow-up.