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• W2616067420 abstract "Literature has shown that a considerable percentage of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) has been performed outside the instructions for use (IFU). However, off-label EVAR durability and long-term patients' safety are still under investigations. We report long-term outcomes after EVAR with respect to a procedure performed according or not to the devices IFU. Included were 880 patients (mean age, 75.6 ± 8.4 years; 824 men) undergoing EVAR between 1999 and 2015 and with a minimum of 1-year follow-up. Different implanted stent grafts (n = 281 [32%] Zenith; n = 64 [7%] AneuRx; n = 14 [2%] Lifepath; n = 64 [7%] Talent; n = 52 [6%] Endurant; n = 38 [4%] Endologix; n = 164 [18%] Excluder; n = 33 [4%] E-Vita, n = 156 [18%] Anaconda; and n = 14 [2%] others) were used. Primary outcomes included all-cause mortality and AAA-related mortality. Secondary outcomes were need for reintervention, endoleak, limb occlusion, aneurysm sac enlargement, and planned perioperative adjunctive maneuvers rate. Median follow-up was 48 months (interquartile range, 24-84 months). A total of 91 patients (10%) were treated outside the IFU (group A), for a short (<15 mm), conical or angulated proximal neck >60° (n = 28 [31%]), for the absence of a suitable distal neck (n = 32; 35%) or for narrowed iliac accesses (n = 31; [34%]). The remaining 789 patients (90%) had a standard EVAR according to each device IFU (group B). Freedom from all-cause and AAA-related death rate was 33.3% and 99.3% at 14 years, without any statistical difference between the two groups. Need for reintervention, endoleak, limb occlusion, and aneurysm sac enlargement rates were 7.7% vs 9.1% (P = .648), 23.1% vs 20.7% (P = .591), 1.1% vs 3.3% (P = .25), and 3.2 vs 9.8% (P = .304) for group A and B, respectively. The rate of planned perioperative adjunctive maneuvers was more frequent (25.3% vs 6.6%; P < .0001) in group A (odds ratio, 0.11; 95% confidence interval, 0.032-0.375). Perioperative adjunctive maneuvers for group A and B were: proximal aortic stenting or stent grafting (8.5% vs 2.2%; P < .0001), iliac angioplasty with or without stenting or femoral endarterectomy or crossover (30.8% vs 7.5%; P < .0001), and hypogastric or inferior mesenteric artery embolization (6.6% vs 12.2%; P = .116). No statistical differences were observed among the stent grafts. Our study shows similar results for off-label EVAR in comparison to standard EVAR with persisting effect at 14 years from repair. These findings were obtained thanks to a fourfold increase of planned perioperative adjunctive maneuvers in the off-label group." @default.
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• W2616067420 date "2017-06-01" @default.
• W2616067420 modified "2023-09-30" @default.
• W2616067420 title "PC032 Planned Perioperative Adjunctive Maneuvers Make Off-Label Endovascular Aneurysm Repair (EVAR) Comparable to Standard EVAR at a Long-Term Follow-Up" @default.
• W2616067420 doi "https://doi.org/10.1016/j.jvs.2017.03.280" @default.
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