Study Supports Medtronic's Endurant EVAR Device for Challenging Aorto-Uni-Iliac Anatomies

December 1, 2014—Misaki M. Kiguchi, MD, et al conducted a study with the objective to review the current anatomic indications for and early results of aorto-uni-iliac (AUI) devices for endovascular aneurysm repair (EVAR). The investigators published the findings in the Journal of Vascular Surgery (2014;60:1452–1459).

The Journal of Vascular Surgery summarized the findings as follows. The investigators reviewed a total of 128 patients receiving an Endurant AUI device (Medtronic, Inc.) in two studies: the Endurant United States investigational device exemption trial (44 patients) and ENGAGE (Endurant Stent Graft Natural Selection Global Postmarket Registry) (84 patients). Anatomic indications were determined by preoperative CT imaging of patients in the investigational device exemption trial and case report forms of ENGAGE registry patients. Baseline characteristics and early results were compared with those of 1,305 patients receiving a bifurcated device in sister studies.

In the study, indications for using the AUI device was unclear from case report forms in two registry cases. Of the remaining 126 patients, there was a unilateral iliac occlusion in 30 patients (23%), a severely narrowed aortic segment in 58 patients (45%), severe iliac occlusive disease in 28 patients (22%), severe iliac tortuosity in 29 patients (23%), and complex iliac aneurysms in 19 patients (15%). Two patients had a previous aortobifemoral graft, and 38 patients (30%) had multiple indications. The AUI cohort included more women than the bifurcated group (19% vs 10%; P < .01) and had more severe comorbidities. Successful deployment was achieved in all AUI cases. 

As reported in the Journal of Vascular Surgery, the 30-day mortality was 2% (bifurcated cohort, 1%; P = .21). More AUI patients underwent EVAR under general anesthesia (81% vs 64%; P < .01), and procedures were longer (110.9 ± 54.9 minutes vs 99.2 ± 44.3 minutes; P = .02). Except for longer intensive care unit stays (19.6 ± 80 hours vs 9 ± 34.8 hours; P = .01) and higher myocardial infarction rates (4% vs 1%; P < .01), outcomes of the AUI cohort were similar to those of the bifurcated cohort. There were no migrations, ruptures, fractures, or open conversions at up to 1-year follow-up.

The investigators concluded that the AUI configuration extends EVAR feasibility to several hostile anatomic conditions. Despite increased comorbidities in the recipient patient population and associated higher rates of postoperative myocardial infarction and respiratory complications, early outcomes with the new generation of AUI devices are acceptable and comparable to those after treatment with bifurcated configurations, stated the investigators in the Journal of Vascular Surgery.