Editor's Choice - Endurant Stent Graft in Patients with Challenging Neck Anatomy "One Step Outside Instructions for Use": Early and Mid-term Results from the EAGLE Registry

OBJECTIVE: The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to prospectively evaluate the technical and clinical success rate of a stent graft used in patients with challenging neck anatomy outside IFU, but within objective anatomical limits.

DESIGN: Prospective, international, multicentre, observational study.

METHODS: From 1 February 2012 to 1 September 2017, patients with an abdominal aortic aneurysm with a challenging infrarenal neck that were deemed suitable for EVAR were prospectively included at 23 European centres. Patients were distributed by anatomy into three groups: short neck (SN): infrarenal neck 5-10 mm in combination with suprarenal angulation (α) ≤45° and infrarenal angulation (β) ≤60°; Medium neck (MN): infrarenal neck 10-15 mm with α ≤60° and β 60°-75° or α 45°-60° and β ≤75°; and long angulated neck (LN): infrarenal neck ≥15 mm with α ≤75° and β 75°-90° or α 60°-75° and β ≤90°. All computed tomography scans were reviewed by an independent core laboratory. Primary outcomes were technical and clinical success. Secondary endpoints were perioperative major adverse events, all-cause mortality, aneurysm-related mortality, endoleaks, migration, and secondary intervention.

RESULTS: One-hundred-and-fifty patients, 81.3% male, were included, SN=55, MN=16, and LN=79. Median follow-up was 36 ±12.6 months. In the overall cohort, technical success was 93.3%. Estimated freedom from aneurysm-related mortality was 97.3% at 3-years. Freedom from secondary interventions was 84.7% at 3-years. Estimated clinical success was 96.0%, 90.8%, and 83.2% at 30-days, 1-year, and 3-years, respectively. Estimated freedom from all-cause mortality, late type IA endoleak, and migration at 3-years was 75.1%, 93.7%, and 99.3%, respectively.

CONCLUSION: The early and mid-term results of the EAGLE registry show that endovascular repair with the Endurant stent graft in selected patients with challenging infrarenal neck anatomy, yields results in line with large 'real-world' registries. Long-term results should be awaited for more definitive conclusions.