Clinical outcomes of endurant II stent-graft for infrarenal aortic aneurysm repair: Comparison of on-label versus off-label use

Abstract

PURPOSE 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). CONCLUSION 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.