Medtronic's Endurant AAA Stent Graft Evaluated in Real-World Challenging Cases From ENGAGE Registry

June 3, 2015—Pieter P.H.L. Broos, MD, et al published findings from an analysis comparing perioperative and postoperative outcomes after endovascular repair of abdominal aortic aneurysms (AAAs) in patients with various neck morphologic features. The investigators used data from the ENGAGE global postmarket registry of the Endurant stent graft (Medtronic plc). The findings are available online ahead of print in the Journal of Vascular Surgery. 

From their evaluation, the investigators concluded that this real-world, global experience shows promising results and indicates that endovascular AAA repair with the Endurant stent graft is safe and effective in patients with challenging aortic neck anatomy. They advised that long-term follow-up of patients is required to confirm these results.

As summarized in the Journal of Vascular Surgery, the investigators categorized patients into three groups according to proximal aortic neck anatomy: regular (REG), intermediate (INT), and challenging (CHA). REG was defined as AAAs with a proximal neck ≥ 15 mm combined with a suprarenal angulation (α) ≤ 45º and an infrarenal neck angulation (ß) ≤ 60º. INT was defined as AAAs with a proximal neck of 10 to 15 mm combined with α ≤ 45º and ß ≤ 60º or with a proximal neck > 15 mm combined with α ≤ 60º and ß = 60º to 75º or α = 45º to 60º and ß ≤ 75º. CHA was defined as infrarenal necks that exceed at least one of the three defining factors.

Overall, 925 patients (75.9%) had REG anatomy, 189 patients (15.5%) had INT anatomy, and 104 patients (8.5%) had CHA anatomy. Patient demographics and risk factors were similar. There was a significant difference in AAA diameter between the REG and CHA groups (59.4 mm vs 65.2 mm). 

The investigators reported that technical success rate was similar among the groups (REG = 99.1% vs INT = 99.5% vs CHA = 97.1%). There were no differences in mortality or the need for secondary procedures within 30 days or at 1 year. A significantly higher rate of type I endoleaks within 30 days was seen in the CHA group compared with the REG and INT groups, but there was no difference at 1-year follow-up, reported the investigators in the Journal of Vascular Surgery.

On April 29, Prof. Hence Verhagen, MD, presented an analysis of results from the ENGAGE registry at the Charing Cross International Symposium in London. Prof. Verhagen’s presentation focused on the influence of neck length on patient outcomes through 4 years of follow-up across a variety of measures, including type I endoleaks, secondary procedures, main body migration, and aneurysm rupture. The ENGAGE registry showed that the device delivered consistently strong results in patients with short and standard neck lengths who were enrolled in the global ENGAGE registry.

Also in April, Else Faure, MD, et al published the 2-year data from ENGAGE in the Journal of Vascular Surgery (2015;61:1138–1145). The ENGAGE investigators concluded that after Endurant stent grafting, the incidence of limb occlusion was low. Additionally, they found that classifying patients as high risk versus low risk according to the algorithm used in this study may help define specific strategies to prevent limb occlusion and improve the overall results of endovascular aneurysm repair using the latest generation of stent grafts.