Empirical Study Of Embeded Stent-graft To Reconstruct Aortic Arch In Canine

Objective: To design and manufacture the embedded branched stent-grafts toreconstruct aortic arch in canine by completely endovascular repair. To researchthe interventional method, feasibility and effectiveness. To provid the stent-graftsdesign proposal for the reconstruction of human aortic arch and finish thepreliminary empirical study for the new product development.Methods:1. Measurement of canine aortic arch: Six25~30kg male hybird canines werechosed. By the angiography and anatomy, we measured the length and diameter ofascending aorta, aortic arch, branch vessel of aortic arch and descending aortarespectively.2. Designment and Manufacture: According to the assembled data, the shape ofthe embeded branched stent-grafts and delivery system were formulated. Thisstent-graft system includes main body with embeded branched stent-graft and sidebranch stent-grafts. They were suctured with Ni-Ti thread and PET graft. Thesystem was manufactured in MicroPort Scientific Corporation (Shanghai).3. Feasibility and observation of therapeutic effect:①Simple branched system:2male dogs, right axillary artery and abdominal aorta were exposed by openoperation. Directed by X-ray, the main body was inserted from AA. Then the wirewas selected into the embeded stent-graft. The side branch stent-graft was insertedand released to reconduct the innominate artery.②Double branched system:5male dogs, bilateral axillary artery and abdominal aorta were exposed by openoperation. The main body was inserted from AA. Then the wires were selectedinto the embeded stent-grafts. The side branch stent-grafts were inserted andreleased to reconduct the innominate artery and LSA.③Endoleak, morphology,migration, and pressure difference between ascending aorta and descending aorta were observed after the reconstruction.Results:The technical success of single branched system was100%, the mean bleedingvolume was60ml. The technical success of double branched system was60%(3/5), the mean bleeding volume was (130.3±8.7) ml. The reasons of failed caseswere LSA can not be reconstructed and CCA were covered.One case existed typeⅠendoleak for the stent-graft was smaller. The successful5cases got nice result. The morphology, position and radiography were satisfied.The difference of pressure between ascending aorta and descending aorta were5mmHg (single branch) and12mmHg (double branch).Conclusions: The design of embeded branched stent-graft is reasonable, itsmanufacture technology is mature and manipulation is practicable. The singlebranched system is simpler, but in human the RCCA-LCCA-LSA bypass isnecessary. The double branched system is more difficult, but in human it cancompletely endovascular reconstruct the aortic arch. This study has importantguiding significance for clinical applications. The design and manufacturetechnology need to be improved in the future. Long term result research isnecessary.