Abstract
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. 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. 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.
Highlights
Since its introduction in the 1990s, endovascular aneurysm repair (EVAR) has surpassed open surgery as the primary choice for treating abdominal aortic aneurysms (AAAs) across most European and North American centres.1e3 Despite an early mortality benefit over open surgery, EVAR patients have a higher re-intervention rate.4e7 In the light of a rapidly developing field of new endovascular devices, there are surprisingly few investigator driven studies with long term follow up addressing occlusive complications for major third generation endograft types
Clinical presentation ranges from no symptoms to severe acute limb ischaemia and may have a fatal outcome because of the risks involved with treatment.9e12 An incidence of 0 e 10.6% and several patient and procedure related risk factors for developing Limb graft occlusion (LGO) have been reported; hostile aorto-iliac anatomy with calcification and severe angulation of the iliac arteries, kinking or excessive limb oversizing and a narrow distal landing zone including the external iliac artery (EIA).9e18 Predicting which patients are at high risk of developing complications is essential for the future of endovascular surgery
Median follow up time for all study participants was 37 months, range (0.2 e 93 months) and differed significantly between the Zenith Alpha (26 months), Excluder (34 months), and Endurant groups (56 months, p < .001)
Summary
Since its introduction in the 1990s, endovascular aneurysm repair (EVAR) has surpassed open surgery as the primary choice for treating abdominal aortic aneurysms (AAAs) across most European and North American centres.1e3 Despite an early mortality benefit over open surgery, EVAR patients have a higher re-intervention rate.4e7 In the light of a rapidly developing field of new endovascular devices, there are surprisingly few investigator driven studies with long term follow up addressing occlusive complications for major third generation endograft types.Limb graft occlusion (LGO), characterised by thrombotic obstruction of blood flow in one or both endograft limbs, is a major cause of re-hospitalisation after EVAR.[8]. Since its introduction in the 1990s, endovascular aneurysm repair (EVAR) has surpassed open surgery as the primary choice for treating abdominal aortic aneurysms (AAAs) across most European and North American centres.1e3 Despite an early mortality benefit over open surgery, EVAR patients have a higher re-intervention rate.4e7 In the light of a rapidly developing field of new endovascular devices, there are surprisingly few investigator driven studies with long term follow up addressing occlusive complications for major third generation endograft types. Previous studies have been underpowered to examine different endografts, and lack long term follow up for newer devices. The aim of this study was to investigate whether endograft device type is associated with risk of LGO after standard EVAR for infrarenal AAA with the Zenith Alpha (Cook Europe, Bjaeverskov, Denmark), Excluder Gore & Assoc., Flagstaff, AZ, USA), and Endurant (Medtronic Inc., Minneapolis, MN, USA) endograft systems
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