Higher Risk for Morbidity and Non-Aortic Related Mortality in Type 2 Endoleak Patients Treated Outside of Instructions for Use

ObjectiveTo evaluate outcomes in patients with type 2 endoleak (T2E) and the impact of treatment outside the device instructions for use (IFU).MethodsThis retrospective single-center study included abdominal aortic aneurysms (AAA) patients who underwent EVAR (2011- 2024). Primary outcomes were 30-day and mid-term complications, reintervention, and mortality by T2E status. Propensity score matching was applied and secondary analysis stratified outcomes by IFU compliance, comparing within (_inIFU) or outside(_outIFU) IFU in each T2E group.ResultsAmong 154 EVAR patients (137 men (89.1%) and 17 women (11.0%); mean age 77.5 ± 7.6 years), 77 were T2E(-), and 77 were T2E(+). Baseline characteristics were similar. Thirty-day complications were comparable (T2E(-): 5, 6.4% vs T2E(+): 2, 2.56%, <i>P</i> = 0.72). The mean follow-up duration was 2.7 ± 2.4 years. Sac diameter change (Δ) decreased in the T2E(-) (7.7 ± 8.4 mm) and enlarged in the T2E(+) (1.79 ± 12.5 mm; <i>P</i> < 0.01). Mid-term graft-related complications (T2E(-): 3, 3.8% vs T2E(+): 49, 62.8%, <i>P</i> < 0.01) and reinterventions (T2E(-): 3, 3.8%, vs T2E(+): 20, 25.6% <i>P</i> < 0.01) were higher in the T2E(+) with no difference in mortality (<i>P</i> = 1.00). These findings remained after excluding type 1 endoleaks. Among the T2E(+), those treated _outIFU had longer hospital stays (_outIFU: 3.0 ± 2.8 days vs _inIFU: 1.8 ± 2.0 days, <i>P</i> = 0.03), higher T1E (_outIFU: 3, 33.3% vs _inIFU: 1, 4.34%, <i>P</i> < 0.01), higher rates of reintervention (_outIFU: 9, 100.0% vs _inIFU:17; 24.6%, <i>P</i> < 0.01) and higher all-cause mortality than those within IFU criteria (_outIFU: 5, 55.0% vs _inIFU: 13, 18.8%, <i>P</i> < 0.01). IFU status did not significantly affect outcomes in T2E(-) patients.ConclusionsT2E is associated with sac growth and increased reinterventions, but not higher mortality. On subgroup analysis, those T2E(+) treated _outIFU had longer hospitalizations, higher T1E rates, more reinterventions, and higher all-cause; but not aneurysmal-related mortality.