Long-term Results of 180 Consecutive Patients with Abdominal Aortic Aneurysm Treated with the Endurant Stent Graft System.

BACKGROUND

Registry studies have shown that the Endurant stent graft is associated with low rates of all-cause and aneurysm-related mortality when used for the endovascular treatment of abdominal aortic aneurysm (AAA). However, many were limited by length of follow-up and all had a proportion of patients lost to follow-up. The aim of this study is to report results from a large, real-world experience using Endurant, utilizing methods to ensure complete ascertainment of mortality.

METHODS

This study describes a large, single vascular unit experience using the Endurant stent graft in consecutive patients treated between August 2008 and March 2019.

RESULTS

One-hundred eighty patients (mean age 76.0 ± 8.6 years; 90% male) with mean AAA diameter of 57.5 ± 10.5 mm underwent endovascular aneurysm repair (EVAR). Technical success was achieved in all cases. At median follow-up of 55.0 months (interquartile range 29.8-79.0), 51 (28.3%) patients had died. Kaplan-Meier estimate of 5-year overall survival and freedom from aneurysm-related death was 71.6% and 99.4%, respectively. Lower survival rates were observed in patients who underwent EVAR at age ≥80 years (59.2% vs. 78.3%, P < 0.01) and with aneurysm diameter ≥70 mm (55.6% vs. 73.8%, P = 0.03). Thirteen endoleaks (7.2%; 4 type 1A, 2 type 1B, 7 type 2) were observed during follow-up (mean time from implantation 8.7 ± 4.2, range 1-52 months). Eleven patients (6.1%) required secondary intervention for limb occlusion (n = 7), endoleak (n = 3), and restenosis (n = 1). Patients treated within (n = 104; 57.8%) and outside (n = 76; 42.2%) the manufacturer's instructions for use (IFU) had similar rates of endoleak (7 [6.7%] vs. 6 [7.9%]; P = 0.76), secondary re-intervention (7 [6.7%] vs. 4 [5.3%]; P = 0.74) and overall-survival (72 [69.2%] vs. 55 [72.3%]; P = 0.46).

CONCLUSIONS

Results from this real-world study of consecutive patients treated for AAA using the Endurant stent graft demonstrate that it is safe and effective, with excellent long-term outcomes for anatomy that falls both inside and outside IFU recommendations.