Feasibility Study Of Total Endovascular Aortic Arch Replacement—the Study From Bench Top To Bed Side

The continuous development of interventional techniquesprovides a new method of treatment for aortic disease such as aortic aneurysm and aortic dissection.Interventional method does not need thoracotomy while it means less trauma,rapid recovery and so on.It is gradually realized and accepted by patients with aortic diseaseas a new method for the treatment.Because of the anatomical characteristics of the aortic arch and it has an important branch of the brachial artery,it is of great challenge to accomplish the aortic arch replacement without opening the thoracic aorta.Previously we independently developed a novel self-designed large vessel stent-graft system with independent intellectual property rights.Now we need to verify the characteristics of it,which is whether it can be applied to the interventional operation and solve the problems related to aortic dissection and diseases or not.Through vitro test on physical properties,chemical properties and biological properties,animal experiment and preliminary clinical trials,we want to establish the animal model which may promote further clinical research.1.In Vitro testTo reach the test requirements of the aortic arch endovascular stent system,and ensure the reliability of the testing process specification and test results,the vitro tests are mainly for physical performance verification,simulation operation,safety and reliability verification of transportation systems,which may show that the performance of aortic arch endovascular stent system meets the product design requirements.It is safe and reliable to be used in human body.2.Animal experimentThis study aimed to evaluate the safety and feasibility of total endovascular repair of the aortic arch using a novel self-designed large vessel stent-graft system with branches in vitro and in a canine model.Thenovel large vessel stent-graft system with branches is composed of the main stent-graft,branched stent-graft and the delivery system.In an in vitro aortic arch simulation test bench,the system was tested and the success rate of stent-graft releasing,anchoring and positioning was recorded and analyzed.Meanwhile,in vivo implantation of the large vessel stent-graft system with branches was carried out in 12 healthy adult crossbreed dogs.The feasibility of using these stent grafts was evaluated with aortography,multi-sliced CT and autopsy six months following the procedure.All stent-graft releasing and positioning were successful in the in vitro test.In the canine model,the large vessel stent-graft systemwith branches was placed successfully in the aortic arch in all fourteen dogs except for 1 death.All dogs survived for at least three months with normal biological behavior.Aortography,MSCT and animal necropsy revealed good fixation in all cases.The ascending aorta,the descending aorta,the brachiocephalic trunk and left subclavian artery were all covered without endoleak.There was no significant obstruction or stenosis in the brachiocephalic branches at the 6 months follow-up.Conclusion1.The novel stent graft system with large branches has good physical properties and is suitable for human aortic arch structure.2.By the animal experiment on endovascular aortic arch replacement,the stent system in operation can successfully reach the predetermined anatomical position.The animals had stable vital signs after operation,which verified that whole endovascular aortic arch replacement on animals is feasible.