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OBJECTIVE:
The Endurant Stent Graft System (Medtronic Cardiovascular, Santa Rosa, CA) is approved for the treatment of abdominal aortic aneurysms (AAA) by the FDA. Here, we report the results of the US investigational device exception (IDE) and post- approval study (PAS) cohorts of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) with follow-up to 5 years.
METHODS:
From 2008 to 2012, all patients with AAA treated under IDE or PAS with Endurant devices in the US (IDE, 31 sites; PAS, 24 sites) were included in the study. Patients receiving aorto-uni-iliac configurations were excluded. All-cause mortality, aneurysm-related mortality, freedom from rupture, and freedom from reintervention were analyzed via Kaplan-Meier survival analysis and are reported at 3- and 5 years.
RESULTS:
A total of 328 patients (150 IDE, 178 PAS) were identified. Median follow-up was 2 years (SD 1.5 years) and 68 patients were followed the full 5 years. Overall survival at 3 and 5 years was 87.2% and 79.9%, respectively. Freedom from aneurysm-related mortality at 3 and 5 years was 99.4% and 98.5%, freedom from rupture was 99.7% and 98.8%, and freedom from secondary intervention was 90.2% and 85.2%, respectively. There were no conversions to open surgery during the study period. 7 (2.2%) stent graft occlusions occurred within 90 days, and 1 occurred at 4 years follow-up.
CONCLUSIONS:
This is the first report of 5-year results for AAA treated with Endurant in the US. Rates of freedom from rupture, secondary intervention and aneurysm-related mortality compare favorably to long-term results for similar devices. 5-year follow-up for the full ENGAGE worldwide registry is expected in 2018.