This study evaluated and compared the midterm results of endovascular aortic aneurysm repair with the Endurant (Medtronic Inc, Santa Rosa, Calif) stent graft system in off-label use in patients with short (<10 mm) proximal aortic necks and in patients treated according to device-specific instructions for use.Methods:
This was a case-control (2:1) single-center retrospective analysis of prospectively collected data performed between September 2008 and December 2012. Analysis identified 19 elective patients with short (<10 mm) proximal necks and mild angulations (≤45°) treated with the Endurant stent graft and 38 patients matched for age, sex, and aneurysm diameter with proximal aortic necks ≥10 mm in length who met the instructions for use. End points included technical and clinical success and freedom from any secondary intervention, any type of endoleak, and aneurysm-related death.Results:
The short-neck group was a mean ± standard deviation age of 71.7 ± 8.9 years, 84% were men, and their mean infrarenal aortic neck length was 6.1 ± 1.2 mm. Mean suprarenal and infrarenal angles were 110° ± 10.4° and 170° ± 15.4°, respectively. Aortic neck diameters were similar between the groups (26.6 ± 3.8 vs 25.7 ± 3.7 mm;P= .36). Primary technical success was achieved in all cases. Off-label patients were more likely to require additional proximal cuff deployment to successfully obtain a seal (21% vs 3%;P= .04). The two patient groups were similar in rates of perioperative mortality, morbidity, and complications. Mean follow-up of 24 ± 12 months revealed no differences in clinical success, freedom from reintervention, and aneurysm-related death. No type I endoleaks were observed in either group during the follow-up period.Conclusions:
The Endurant stent graft system applied off-label in patients with very short aneurysm necks (<10 mm) with mild angulation showed acceptable treatment results. These midterm results might suggest its use in carefully selected patients with very short neck anatomy. Long-term data are needed to verify the observed durability of the Endurant stent graft.