title: On-label use of commercially-available abdominal endografts for para-anastomotic aneurysms and pseudoaneurysms after infrarenal abdominal aortic aneurysm open repair.
abstract: OBJECTIVE
  To analyze feasibility and outcomes of endovascular aortic repair (EVAR) with a strictly on-label use of abdominal aortic endografts (OnL-EVAR) to treat para-anastomotic aneurysms (PAAs) and pseudoaneurysms (PSAs) after infrarenal abdominal aortic aneurysm open repair (OR).
  
  
  METHODS
  The data of all consecutive patients treated between 1999 and 2012 for non-infected abdominal PAAs and PSAs at our center were prospectively collected. All cases fit for EVAR based on the instructions for use of a series of abdominal aortic endografts commercially available during the study period were scheduled for OnL-EVAR regardless of patients' surgical risk. Any patients unfit for OnL-EVAR underwent OR or other complex endovascular techniques.
  
  
  RESULTS
  One hundred and forty-three patients were collected; 78 underwent OR and 65 endovascular repair with different strategies. Coil embolization, hybrid, and chimney/periscope grafts techniques were limited to seven patients unfit both for OR and OnL-EVAR. Inclusion criteria for OnL-EVAR were reached in 58 patients for an overall OnL-EVAR feasibility of approximately 40% (21% for PAAs and 55% for PSAs). In particular, OnL-EVAR feasibility was 19% in case of involvement of proximal aortic anastomosis, 71% for distal aortic anastomosis, and 80% for iliac arteries. Overall, 25 aortouniiliac and 11 bifurcated implants were performed, single proximal aortic cuffs were used in 10 patients, and iliac extension in 12. Primary technical success was 98% without perioperative mortality. At a median follow-up of 67 months (range: 1-144 months), cumulative aneurysm-related mortality was 7%, endograft migration 7%, and reintervention was 17%. Life-table analysis showed actuarial survival and freedom from aneurysm-related death at 1, 3, and 5 years of 100%, 98%, and 95%, and of 100%, 98%, and 95%, respectively. Freedom from aortic reintervention or open conversion at 1, 3, and 5 years was 94%, 90%, and 85%.
  
  
  CONCLUSIONS
  Feasibility of OnL-EVAR was limited for PAAs and PSAs, with a rate that was lower than 20% in case of involvement of proximal aortic anastomosis. Aortouniiliac configuration was the most commonly feasible implant and, despite strict on-label use of abdominal devices, the rate of late complications and reinterventions was high.
authors.affiliation: Vascular Surgery, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Y
authors.initials: Y
authors.lastname: Tshomba
authors.forename: D
authors.initials: D
authors.lastname: Mascia
authors.forename: A
authors.initials: A
authors.lastname: Kahlberg
authors.forename: E M
authors.initials: EM
authors.lastname: Marone
authors.forename: G
authors.initials: G
authors.lastname: Melissano
authors.forename: R
authors.initials: R
authors.lastname: Chiesa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical; D017541:Aneurysm, False / Q000000981:diagnostic imaging / Q000601:surgery*; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D057510:Endovascular Procedures; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005548:Foreign-Body Migration / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000601:surgery; D011859:Radiography; D019233:Retreatment; D012189:Retrospective Studies
keywords: Abdominal aortic aneurysm repair; Aortic endografts; EVAR; Endovascular treatment; Para-anastomotic aneurysm; Pseudoaneurysm