Outcome and Safety of Aorfix™ Stent Graft in Highly Angulated Necks - A Prospective Observational Study (Arbiter 2)

Objectives: Severe neck angulation is associated with poor outcome following endovascular aneurysm repair. The aim was to study the safety and early outcome of patients with infrarenal aortic aneurysms with severe neck angulation (60-90 degrees) treated with the Aorfix (TM) endovascular stent graft. Design/methods: This was a non-randomized prospective observational study of 30 patients with infra-renal abdominal aortic aneurysms with highly angulated necks. Outcomes were primary technical success, 30 day and short term (30 days-6 months) clinical success and other patient morbidity at 30 days. Results: Median neck angulation was 81.2 degrees. Initial technical success was 93.3% (n = 28) with 2 stents deployed too low. Intra-operatively 3 patients initially had type I endoleaks, but all were resolved by ballooning. 30 day clinical success was 96.7%: there were no type I or type III endoleaks observed, and no reports of graft thrombosis or migration. Early clinical failure was accounted for by one perioperative death (3% mortality). No aneurysm-related interventions were required during follow-up. At 6 months two patients were reported as having type I endoleaks, although both sacs have reduced in size. Neither has required intervention. No patient has died due to aneurysm rupture or required removal of the endograft. Conclusion: The results of this study support the continued application of the Aorfix (TM) graft to the highly angulated neck. (C) 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.