title: A feasibility study of total endovascular aortic arch replacement: From stent-graft design to preclinical testing.
abstract: OBJECTIVE
  This study aimed to evaluate the safety and feasibility of total endovascular repair of the aortic arch using a novel designed stent-graft system (Yanger stent-graft system; Lifetech Scientific, Shenzhen, China) in vitro and in a canine model.
  
  
  METHODS
  The Yanger stent-graft system is composed of a main stent-graft, branched stent-graft, and a 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 Yanger stent-graft system was carried out in 16 healthy adult crossbreed dogs. The feasibility of using these stent-grafts was evaluated with aortography, multislice computed tomography, and autopsy 6 months after the procedure.
  
  
  RESULTS
  All stent-graft releasing and positioning were successful for in vitro test. In the canine model, the Yanger stent-graft system was placed successfully in the aortic arch in all 14 dogs with the exception of 2 mortalities. All dogs survived for at least 3 months with normal physiologic signs. Aortography, multislice computed tomography, and animal necropsy revealed good fixation in all cases. The ascending aorta, descending aorta, brachiocephalic trunk, and left subclavian artery were all covered without endoleak. There was no significant obstruction or stenosis in brachiocephalic branches at the 6-month follow-up.
  
  
  CONCLUSIONS
  Total endovascular repair of aortic arch with the novel designed Yanger stent-graft system is safe and feasible in preclinical studies. With a better understanding of preclinical knowledge, patient selection criteria and first-in-human studies will be addressed.
authors.affiliation: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China. Electronic address: yangjian1212@hotmail.com.
authors.forename: Jian
authors.initials: J
authors.lastname: Yang
authors.affiliation: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Weixun
authors.initials: W
authors.lastname: Duan
authors.affiliation: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Dinghua
authors.initials: D
authors.lastname: Yi
authors.affiliation: Department of Cardiovascular Surgery, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Shiqiang
authors.initials: S
authors.lastname: Yu
authors.affiliation: Department of Anesthesiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Ma
authors.affiliation: School of Pharmacy, College of Health Sciences, University of Wyoming, Laramie, Wyo.
authors.forename: Jun
authors.initials: J
authors.lastname: Ren
mesh_terms: D000818:Animals; D001013:Aorta, Thoracic / Q000000981:diagnostic imaging / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D004285:Dogs; D057510:Endovascular Procedures / Q000295:instrumentation*; D005240:Feasibility Studies; D005260:Female; D008297:Male; D008422:Materials Testing; D023421:Models, Animal; D061330:Multidetector Computed Tomography; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D018615:Ultrasonography, Doppler, Color
keywords: brachiocephalic trunk (BCT); deep hypothermic circulatory arrest (DHCA); left subclavian artery (LSCA); multisliced CT (MSCT); thoracic endovascular aortic repair (TEVAR)