Comparison Study Of Iliac Branch Endoprosthesis When Used On And Off Label
Limael E. Rodriguez, M.D.1, Emily Malgor, M.D.1, Adam Carroll, M.D.1, Ryan T. Calkins, B.S.2, John Eun, M.D.1, Mark Nehler, M.D.1, Donald L. Jacobs, M.D.1, Rafael Malgor, M.D.1.
1University of Colorado Anschutz School of Medicine Department of Surgery, Division of Vascular Surgery, Aurora, CO, USA, 2University of Colorado School of Medicine, Aurora, CO, USA.
Objectives: In this study, we compare how instruction for use (IFU) affected peri-operative and intermediate outcomes for common iliac artery aneurysms (CIAA) treated with the GORE EXCLUDER iliac branch endoprosthesis (IBE). Methods: A retrospective analysis was performed of all patients treated at two affiliated academic centers from September 2016 to May 2020. Outcomes were compared between IFU and non-IFU IBE cases. Criteria for non-IFU included: 1) use with a non-GORE aortic endoprosthesis (n=11), 2) isolated IBE (n=2), and 3) requiring non-dedicated covered stents for additional extension into a more suitable landing zone in the ipsilateral internal iliac artery or one of its branches (n=11). Peri-operative and intermediate term data was collected for both groups. The primary endpoints were freedom from major adverse event (MAE) at 30 days and primary effectiveness at 1 year. Results: A total of 51 CIAA (39 patients) were treated with an IBE. Overall, 15 patients were treated under IFU and 24 non-IFU. The IFU group mean age was older (72 vs 67 years, p=0.03), and males (97%) were primarily treated. Comorbidities were similar except non-IFU had more patients with previous EVAR on presentation (0 vs 4 cases, p=0.04). Procedure (178 vs 264 min, p=0.02) and fluoroscopy (52 vs 74 min, p=0.04) times were longer in the non-IFU group. Technical success was 100% for both groups, and there was no difference in device related reintervention at 30 days (0 vs 1, p=0.44). There was no MAE in either group at 30 days. Intervention for any endoleak was similar between the groups (2 vs 3, p=0.94). There was no difference for mean time of last CTA imaging follow up (499 vs 377, p=0.36). Percent CIAA sac regression was similar between the groups (19% vs 18%, p=0.21). There was no difference for primary effectiveness at 1 year (93% vs 92%, p=0.85). There was one death per group at one year not related to an aortic or iliac cause. Conclusions: Despite higher risk anatomical characteristics and more technically challenging procedures, non-IFU IBE did not significantly alter outcomes. Regardless of IFU status, IBE is associated with high procedural success and low reintervention rates at intermediate term follow-up.
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