Limb Graft Occlusion Following Endovascular Aneurysm Repair for Infrarenal Abdominal Aortic Aneurysm with the Zenith Alpha, Excluder, and Endurant Devices: a Multicentre Cohort Study

Abstract

Objective: Limb graft occlusion (LGO) is a serious complication after endovascular aneurysm repair (EVAR) and while device development enables treatment of increasingly complex aortic anatomy, little is known about how endograft type affects the risk of occlusion. This observational study aimed to explore the incidence of LGO after EVAR for three major endograft systems.

Methods: All patients with standard EVAR as the primary intervention for infrarenal abdominal aortic aneurysm (AAA), between January 2012 and December 2018, at five Swedish vascular surgery centres, were included in this multicentre retrospective cohort study. LGO was defined as a total limb occlusion regardless of symptoms, or a treated significant stenosis. A nested case control (NCC) design with incidence density sampling of 1:3 was used for analysis of potential per-operative and morphological risk factors. Conditional logistic regression was used to estimate multivariable odds ratios (OR) with 95% confidence intervals (CI) RESULTS: A total of 924 patients were included. The majority were male (84%), the mean age was 76 years (± 7.5 SD), and median AAA diameter was 59 mm (IQR 55, 67). Patients were treated with Zenith Alpha (n = 315, ZISL limbs), Excluder (n = 152, PLC/PXC limbs), and Endurant (n = 457, ETLW/ ETEW limbs). During median follow up of 37 months (IQR 21, 62), 55 occlusions occurred (5.9%); 39 with Zenith Alpha (12.4%), one with Excluder (0.7%), and 15 with Endurant (3.3%). In the NCC analysis, the Zenith Alpha device (OR 5.31, 95% CI 1.97 - 14.3), external iliac artery (EIA) landing (OR 5.91, 95% CI 1.30 - 26.7), and EIA diameter < 10 mm (OR 4.99, 95% CI 1.46 - 16.9) were associated with an increased risk of LGO.

Conclusion: Endograft device type is an independent risk factor for LGO after EVAR. Specifically, the Zenith Alpha demonstrated an increased risk of LGO compared with the Endurant and Excluder devices. In addition, a narrow EIA and landing zone in EIA are also risk factors for LGO.

Keywords: Abdominal aortic aneurysm; Endovascular aneurysm repair; Graft thrombosis; Limb occlusion; Post-operative complication.