RÉSUMÉ
OBJECTIVE: The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to evaluate prospectively the technical and clinical success rate of a stentgraft used in patients with challenging neck anatomy outside the instructions for use (IFU) but within objective anatomical limits. METHODS: This was a prospective, international, multicentre, observational study. From 1 February 2012 to 1 September 2017, patients with an abdominal aortic aneurysm with a challenging infrarenal neck that were deemed suitable for endovascular aneurysm repair were included prospectively 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 [ß] ≤ 60°); medium neck (MN; infrarenal neck 10 - 15 mm with α ≤ 60° and ß 60° - 75° or α 45°- 60° and ß ≤ 75°; and long angulated neck (LN; infrarenal neck ≥ 15 mm with α ≤ 75° and ß 75°- 90° or α 60°- 75° and ß ≤ 90°. All computed tomography scans were reviewed by an independent core laboratory. Primary outcomes were technical and clinical success. Secondary endpoints were peri-operative 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, LN = 79). The median follow up was 36 ± 12.6 months. In the overall cohort, the technical success rate was 93.3%. Estimated freedom from aneurysm related death was 97.3% at three years. Freedom from secondary interventions was 84.7% at three years. Estimated clinical success was 96.0%, 90.8%, and 83.2% at 30 days, one year, and three years, respectively. Estimated freedom from all cause mortality, late type IA endoleak, and migration at three years was 75.1%, 93.7%, and 99.3%, respectively. CONCLUSION: The early and midterm results of the EAGLE registry show that endovascular repair with the Endurant stentgraft in selected patients with challenging infrarenal neck anatomy yields results in line with large "real world" registries. Long term results are awaited for more definitive conclusions.
RÉSUMÉ
The purpose of this study was to evaluate single-center results with selective use of Gore Excluder limbs (W.L. Gore & Associates, Flagstaff, AZ) in a Cook Zenith body (Cook Inc, Bloomington, IN) for elective endovascular abdominal aortic aneurysm (AAA) repair. A prospectively held database for patients with AAA, who were treated endovascularly between March 1999 and July 2008, was queried for patients treated with a Cook Zenith body and one or two Gore Excluder limbs. Indication, technical success, late limb occlusion, and disconnection were evaluated. From 276 patients who were treated with a Zenith body, 29 underwent repair with hybrid graft components with, in total, 41 Gore Excluder limbs. The indication was always complex iliac anatomy. The primary technical success rate in this group was 89% (26 of 29 patients), with a primary assisted technical success rate of 100%. Mortality at 30 days was 0%. The mean follow-up was 19.4 months (range 2-64 months). Late mortality was 13.8% (4 of 29), with no aneurysm-related death. No graft limb occlusion or disconnection occurred during follow-up. No reintervention was needed in the hybrid endograft group. The use of a Cook Zenith body with Gore Excluder limb(s) in case of adverse iliac anatomy is feasible and showed no adverse effects at the midterm follow-up.