title: Midterm outcomes of endovascular repair for abdominal aortic aneurysms with the on-label use compared with the off-label use of an endoprosthesis.
abstract: OBJECTIVE
  Endovascular repair of an abdominal aortic aneurysm (EVAR) is sometimes not performed in accordance with the instructions for use (IFU) of the endoprosthesis ("off-label use"). We investigated whether the off-label use of the endograft affected the outcomes of EVAR.
  
  
  METHODS
  Demographic, anatomical, intraoperative and follow-up data on 100 patients in whom the endograft was used on-label in EVAR were compared retrospectively with the corresponding data of 50 patients with off-label endograft use.
  
  
  RESULTS
  The endograft IFU were most often not followed in patients with challenging aortic neck anatomy or iliac access or fixation, steep neck angulation or bilateral hypogastric artery embolization. Compared with patients in whom the device was used on-label, patients with off-label use had significantly higher rates of intraoperative type I or III endoleaks and proximal aortic cuff placement or other adjunctive procedures. However, there were no midterm differences between the two groups in the rates of type 1b or II endoleaks, sac enlargement, device-limb occlusion or patient survival.
  
  
  CONCLUSIONS
  Most midterm outcomes of EVAR in which the endografts were used off-label were similar to those associated with on-label use of the devices. Off-label use of EVAR endoprostheses is feasible, but requires the use of special techniques in patients with challenging anatomical features.
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashiku, Fukuoka, 812-8582, Japan, tak@qa2.so-net.ne.jp.
authors.forename: Takuya
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Shinichi
authors.initials: S
authors.lastname: Tanaka
authors.forename: Jun
authors.initials: J
authors.lastname: Okadome
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Kyuragi
authors.forename: Ryota
authors.initials: R
authors.lastname: Fukunaga
authors.forename: Eisuke
authors.initials: E
authors.lastname: Kawakubo
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Itoh
authors.forename: Jin
authors.initials: J
authors.lastname: Okazaki
authors.forename: Ken
authors.initials: K
authors.lastname: Shirabe
authors.forename: Atsushi
authors.initials: A
authors.lastname: Fukuda
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D057510:Endovascular Procedures; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome