Immediate results of the expanding indications for treatment with standard EVAR in patients with challenging anatomies, a multi-centric prospective evaluation - EXTREME Study

Aims: to report the 30-day technical and clinical success with endovascular repair using the ultra-low-profile Ovation stent-graft in patients judged out of instruction for use (IFU) for conventional endografts, while amendable to treatment inside the IFU for Ovation (Endologix, Irvine, CA - USA). Methods and results: One-hundred-twenty-two patients (78.65±7.67years; 111 male) were enrolled. Patients were evaluated outside IFU for standard endografts because of the absence of a suitable proximal aortic neck in 109 cases (89.3%), of inadequate access vessels in 13 (10.7%), or both in 111 (90.9%). Mean aneurysm (AAA) diameter was 52.96±10.1mm, mean aortic neck length was 7.75±6.05 mm. Technical success (98.4%) was achieved in all but two patients due to a Type Ia endoleak. At completion angiography, 15 (12.3%) patients presented a Type II endoleak. All patients underwent 30-day follow-up. Primary clinical success at 1 month was 96.8%, assisted clinical success 98.4%. There were no type I endoleak, while twelve (9.8%) Type II endoleaks were still evident, in absence of sac expansions. Two patients (1.6%) presented an asymptomatic limb occlusion. Conclusions: our experience suggests that in a selected population of patients with challenging anatomy outside the IFU for conventional endograft, EVAR by Ovation stent-graft can be safely performed with satisfactory immediate outcomes.