title: A new device as an open stent graft for extended aortic repair: a multicentre early experience in Japan.
abstract: OBJECTIVE
  Open stent grafting for extended aortic repair has been widely carried out around their world. We reported the effectiveness of a new device as an open stent graft for extended aortic repair.
  
  
  METHODS
  A new device was used as an open stent graft in this study. The graft part of the device has a woven structure made of Nitinol wire, a superelastic/shape-memory alloy. The subjects of this study were patients aged 20-84 with aneurysms (n = 38) or aortic dissection (n = 22) in the thoracic aorta, including the distal aortic arch and the proximal descending aorta. This study was a multicentre, non-blinded study. The follow-up period was 36 months.
  
  
  RESULTS
  Three subjects (5.0%) died during hospitalization due to multiorgan failure. Spinal cord injury (SCI) was observed in 4 subjects (6.7%): paraplegia in 1 and paraparesis in 3 subjects. The 3-year survival rate was 76.7% overall: 68.4% for the subjects diagnosed as having aortic aneurysms (the aortic aneurysm group) and 90.9% for those having aortic dissection (the aortic dissection group). For the aortic aneurysm group, thrombus formation in the aortic aneurysm was observed in 97% of the patients 6 months after operation, and in 100% 12 months after operation. Meanwhile, for the aortic dissection group, with regard to the false lumen of aortic dissection, thrombus formation was observed in 94% of the patients 6 months after operation, in 94% 12 months after operation and in 100% 24 months after operation. Expansion of the aortic aneurysm sac was observed in 2 subjects (6.1%). Among these 2 subjects, endoleak was observed in 1 subject, which was improved by additional thoracic endovascular aortic repair.
  
  
  CONCLUSIONS
  The safety and effectiveness of this investigational device was verified over a period up to 36 months after operation. A long-term follow-up would be necessary to further verify the effectiveness of the device in the future.
authors.affiliation: Department of Cardiovascular Surgery, Akane-foundation, Tsuchiya General Hospital, Hiroshima, Japan uchidacvs@yahoo.co.jp.
authors.forename: Naomichi
authors.initials: N
authors.lastname: Uchida
authors.affiliation: Department of Cardiovascular Surgery, Hiroshima City Asa General Hospital, Hiroshima, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Katayama
authors.affiliation: Division of Cardiovascular Surgery, Kishiwada Tokushukai Hospital, Kishiwada, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Higashiue
authors.affiliation: Department of Cardiovascular Surgery, Nihon University Itabashi Hospital, Tokyo, Japan.
authors.forename: Motomi
authors.initials: M
authors.lastname: Shiono
authors.affiliation: Department of Cardiovascular Surgery, Nihon University Itabashi Hospital, Tokyo, Japan.
authors.forename: Mitsumasa
authors.initials: M
authors.lastname: Hata
authors.affiliation: Department of Cardiovascular Surgery, Kitakanto Junkanki Hospital, Gunma, Japan.
authors.forename: Kazutomo
authors.initials: K
authors.lastname: Minami
authors.affiliation: Department of Cardiovascular Surgery, Tenri Hospital, Tenri, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Yamanaka
authors.affiliation: Department of Cardiovascular Surgery, Faculty of Medicine, Oita University, Oita, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Miyamoto
authors.affiliation: Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Sawa
authors.affiliation: Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Kuratani
authors.affiliation: Department of Cardiovascular Surgery, Morinomiya Hospital, Osaka, Japan.
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kato
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000784:Aortic Dissection / Q000000981:diagnostic imaging / Q000601:surgery; D001011:Aorta / Q000000981:diagnostic imaging / Q000601:surgery*; D001014:Aortic Aneurysm / Q000000981:diagnostic imaging / Q000601:surgery; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011474:Prosthesis Design; D015607:Stents
keywords: Aneurysm; Aortic dissection; Aortic repair; New device; Stent graft