Medtronic's 36-mm–Diameter Endurant Stent Graft for EVAR Evaluated in European Registry

September 6, 2017—Findings from a multicenter European registry evaluating the performance of the 36-mm–diameter Endurant stent graft (Medtronic) for patients with abdominal aortic aneurysm (AAA) undergoing endovascular aortic repair (EVAR) were published by Andrés Reyes Valdivia, MD, et al in CardioVascular and Interventional Radiology (2017;40:1514–1521).

The study investigators collected and retrospectively analyzed data on EVAR patients treated with a 36-mm–diameter Endurant device at three European academic vascular centers between 2007 and 2015. Primary endpoints were the absence of type Ia endoleak in the early and midterm follow-up periods and aneurysm sac stabilization or shrinkage. Secondary endpoints were 30-day mortality, overall survival, and secondary interventions. The investigators also performed subgroup analysis of outcomes in the on-label (ONL) versus off-label (OFL) device use cohorts.

As summarized in CardioVascular and Interventional Radiology, the study was composed of 73 patients. The mean follow-up was 30.1 ± 16.2 months. The mean aortic neck diameter was 29.5 ± 1.9 mm.

The investigators reported that primary technical success was achieved in 69 patients (94.5%). Five patients (6.8%) were found to have developed a type Ia endoleak, three during the first month,and the other two at 2 years. Overall EVAR-related mortality was 4.1% (n = 3). Subgroup analysis focused on the OFL cohort (n = 44) versus the ONL patients (n = 29). Two of the OFL patients (4.5%) had a type Ia endoleak versus three (10.3%) in the ONL group.

The use of the largest-diameter Endurant stent graft device appears to be a reasonable option for EVAR treatment of AAAs with a large-diameter proximal neck; however, assessment of a larger group of patients followed in the long term will be necessary for a more definitive statement on such strategy, concluded the investigators in CardioVascular and Interventional Radiology.