LAUSR

OBJECTIVE To report procedural results and mid-term follow-up outcomes of patients treated with endovascular aneurysm sealing for abdominal aortic disease. METHODS In this retrospective observational study, all patients treated with endovascular aneurysm sealing between March 2013 and January 2018 for abdominal aortic aneurysm or abdominal penetrating aortic ulcer were included. The datasets included demographics, aneurysm morphology, procedural and clinical surveillance outcomes. Furthermore, patients treated within the original Instructions for Use (IFU-group) were compared to patients treated outside the IFU (non-IFU-group) with regards to survival, reintervention-free survival, freedom from type 1 endoleak and freedom from stentgraft migration. RESULTS 70 patients (67 male, median age 72.5 years) were included. 65 patients were treated for abdominal aortic aneurysm and five patients for abdominal penetrating aortic ulcer. 69 cases were treated electively (98.6%). Technical success was achieved in 68 cases (97.1%). The median clinical follow up was 50.5 months (IQR 29.3-62.7) with a median CT-angiographic follow-up of 38.5 months (IQR 17.1-60.2). There were five deaths during the study period (7.1%), four of which were aneurysm-related (5.7%). Five secondary abdominal aortic aneurysm ruptures were detected (7.1%). Overall, 25 of 70 patients (35.7%) underwent 35 reinterventions, mostly due to thrombotic complications (18.6%), stentgraft migration (17.1%) and type 1 endoleak (12.9%). 15 patients were treated outside of IFU (non-IFU-group) (21.4%). The estimated reintervention-free survival for the entire cohort at 30 days, one, three and five years was 94.3%, 88.5%, 72% and 56.9%, respectively. Freedom from stentgraft migration at one, three and five years was 98.6%, 82% and 47.3%, respectively. The estimated freedom from type 1 EL at 30 days, one, three and five years in the IFU-group was 100%, 100%, 94.9% and 91.1% and significantly different when compared to the non-IFU-group with 79.5%, 72.2%, 72.2% and 72.2% (p=0.012). CONCLUSION While technical and initial results were satisfying, mid-term results were disappointing. The enforcement of a close follow up protocol for all patients treated with endovascular aneurysm sealing, especially vigilant for stentgraft migration to prevent secondary type 1 endoleak and rupture, is strongly recommended.