The Gore Excluder US Multi-Center Trial: Analysis of adverse events at 2 years

Although open surgical repair of abdominal aortic aneurysms remains the standard of care, endovascular repair is becoming an attractive alternative as more long-term outcome data become available to show its safety and efficacy. The authors review data on the 2-year outcome of the pivotal US multi-center, prospective Gore Excluder Trial. Patients treated with the Excluder endograft (W.L. Gore, Flaggstaff, AZ) had less blood loss (310 ± 19 v 1,590 ± 124 mL; P < .0001), required fewer homologous transfusions (6% v 32%; P < .0001), and had faster inpatient recovery (2.0 ± 0.1 v 9.8 ± 1.4 days; P < .0001) compared with those treated with open repair. Early major adverse events were reduced significantly in the patients treated with the endograft (14% v 57% in control; P < .0001), and this persisted at 2 years. There was no difference in overall survival rate (P = .13). There were no deployment failures, early conversions, or aneurysm ruptures. At the 2-year time-point, trunk migration occurred in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. There was a 7% annual reintervention rate in the endograft group in the first 2 years. The Excluder endograft is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysms with appropriate anatomy. Published by Elsevier Inc.