title: Cinical outcomes of Endurant II stent-graft for infrarenal aortic aneurysm repair: comparison of on-label versus off-label use.
abstract: OBJECTIVE
  We aimed to compare the outcomes of the Endurant II (Medtronic) stent-graft used under instructions for use versus off-label in high-risk patients considered unfit for conventional surgery.
  
  
  METHODS
  Data from patients treated with the Endurant II stent-graft between December 2012 and March 2015 were retrospectively analyzed. Sixty-four patients were included. Patients were assigned to group A if treated under instructions for use (n=34, 53%) and to group B if treated off-label (n=30, 47%). Outcome measures included perioperative mortality and morbidity, survival, freedom from reintervention, endoleak incidence, in-hospital length of stay, and mean stent-graft component used. Mean follow-up was 22.61±12 months (median, 21.06 months; range, 0-43 months).
  
  
  RESULTS
  One perioperative mortality (1.6%) and one perioperative complication (1.6%) occurred in group B. At two months follow-up, one iliac limb occlusion (1.6%) occurred in group A. No type I/III endoleaks were recorded. A type II endoleak was identified in three cases (4.7%). Overall survival at three years was 89% (97% for group A, 82% for group B; P = 0.428). Reintervention-free survival at three years was 97% for both groups (P = 0.991). A longer in-hospital stay was observed in group B (P = 0.012).
  
  
  CONCLUSIONS
  The Endurant II (Medtronic) new generation device was safe in off-label setting at mid-term follow-up. The off-label use of the Endurant II (Medtronic) is justified in patients considered unfit for conventional surgery. Larger studies are required in this subgroup of patients.
authors.affiliation: Vascular Surgery Unit, AOUP "P. Giaccone", University of Palermo, Palermo, Italy. felice.pecoraro@unipa.it.
authors.forename: Felice
authors.initials: F
authors.lastname: Pecoraro
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Corte
authors.forename: Ettore
authors.initials: E
authors.lastname: Dinoto
authors.forename: Giovanni
authors.initials: G
authors.lastname: Badalamenti
authors.forename: Salvatore
authors.initials: S
authors.lastname: Bruno
authors.forename: Guido
authors.initials: G
authors.lastname: Bajardi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis / Q000009:adverse effects*; D057867:Endoleak / Q000453:epidemiology* / Q000209:etiology; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D018570:Risk Assessment; D015607:Stents / Q000009:adverse effects*; D016019:Survival Analysis; D016896:Treatment Outcome