Evaluation of the Endurant stent graft under instructions for use vs off-label conditions for XXXX repair.

@entity1 @entity449 @entity1070 @entity2948 @entity439 @entity715 @entity1028
BACKGROUND: This study evaluated the early and intermediate results of @entity449 repair (EVAR) using the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, @entity2948 ) in @entity1 treated according to device-specific instructions for use (IFU) for the proximal aortic neck compared with those obtained in @entity1 treated in an off-label (OL) situation. METHODS: Between November 2007 and March 2010, 177 consecutive @entity1 with @entity1028 ( @entity1028 ) were treated with the Endurant stent graft at our centers. The IFU for the Endurant stent graft included a proximal neck of 15 mm in length and <75   of angulation or 10 mm of neck length and <60   of angulation. The 121 @entity1 (68.4%) operated on according to IFU were compared with 56 (31.6%) who underwent EVAR in OL circumstances to evaluate significant differences in demographics, intraoperative technical factors, and early (30 days) and intermediate outcomes (1 year). RESULTS: Significantly more @entity1 were aged >80 years in the OL group (37.5% vs 19%, P = .008), and they also had larger @entity439 (59    10.6 vs 55.9    10.8 mm, P = .05) and required a longer procedure time (69.3    27.2 vs 60.8    20.4 minutes, P = .02). At 30 days, the risk of @entity1070 was higher in the OL group (2 @entity1 , 3.6% vs 0 in IFU), but this did not reach statistical significance (P = .09). The two groups were similar in rates of perioperative mortality, major morbidity, technical success, clinical success, complications, and reinterventions. At 1 year, there were no differences between the two groups in survival, freedom from any device-related reinterventions, and freedom from graft @entity715 . Estimated 1-year freedom from @entity1070 was 100% in the IFU group vs 93.3% in the OL group (P = .01). CONCLUSIONS: In @entity1 with both normal and complex anatomy of the proximal aortic neck, the Endurant stent graft obtained acceptable results, with no difference in survival, morbidity, or reinterventions. However, there was a greater risk of @entity1070 when OL indications were applied. Longer term follow-up is required to evaluate the effectiveness of this endograft in preventing late @entity439 .
