Vascular and endovascular surgery · 2025
Higher Risk for Morbidity and Non-Aortic Related Mortality in Type 2 Endoleak Patients Treated Outside of Instructions for Use.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Esquetini-Vernon Camila, Farres Houssam, Polania-Sandoval Camilo, Claudio-Medina Yetzali, Morales-Arroyo Hennessy, Ritchie Charles, Jacobs Christopher, Paz-Fumagalli Ricardo, Toskich Beau, Vandenberg Jonathan, Mahajan Biraaj, Erben Young
Аннотация
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%, P = 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; P < 0.01). Mid-term graft-related complications (T2E(-): 3, 3.8% vs T2E(+): 49, 62.8%, P < 0.01) and reinterventions (T2E(-): 3, 3.8%, vs T2E(+): 20, 25.6% P < 0.01) were higher in the T2E(+) with no difference in mortality (P = 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, P = 0.03), higher T1E (outIFU: 3, 33.3% vs inIFU: 1, 4.34%, P < 0.01), higher rates of reintervention (outIFU: 9, 100.0% vs inIFU:17; 24.6%, P < 0.01) and higher all-cause mortality than those within IFU criteria (outIFU: 5, 55.0% vs inIFU: 13, 18.8%, P < 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.