RS14 - 10-Year Experience in Remediation for Endologix AFX Graft Failure

Objectives: Prior studies have described the delayed failure of the Endologix AFX Endovascular AAA System. Described repair options include relining with a contemporary endograft or graft explant; however, no direct comparisons have been performed between these treatments. The purpose of this study is to compare graft relining and graft explant in order to guide future decision-making for failing AFX devices.

Methods: A retrospective review of all AFX endografts implanted at our tertiary care center from 2011-2019 was performed. Major remediations via endograft relining or graft explant through November 2023 were then identified. The primary composite endpoint was reintervention-free survival after remediation. Secondary endpoints included perioperative mortality, all-cause mortality, AAA-related mortality, and major and minor reinterventions. Exclusion criteria included reline with a recalled AFX device or use of additional non-AFX devices during the original aneurysm repair.

Results: Out of a total 217 AFX device implants, 52 patients (24%) underwent remediation with 36 devices relined (69%) and 16 grafts explanted (31%) (Table I). The original devices were 40 AFX Strata, 8 AFX Duraply, and 4 AFX2. The indications for remediation were endoleak with sac growth (53%), endoleak only (4%), sac growth only (23%), and aneurysm rupture (17%). The devices used for relining were 16 AFX2, 10 Medtronic Endurant, four Gore Excluder, two Endologix Ovation/Alto, one Cook Z-Fen, and three that used a combination of devices. At the time of intervention, aneurysms that underwent explant compared to relining were more commonly juxta/pararenal (25% vs. 6%, P< 0.05) and/or ruptured (38% vs. 8%, P< 0.01). There were no significant differences in age, sex, comorbidities, original AFX device, endoleak type, and mean AAA size between the two cohorts. Perioperative mortality was higher after graft explant (25% vs. 0%, P< 0.01). However, there was no significant difference in 1-year survival (68% vs.77%, P= 0.35) or aneurysm-related mortality (27% vs. 0%, P=0.12). There were higher rates of reintervention following reline (explant: 0% vs. reline: 13% at one-year, P=0.03), but there was no difference in reintervention-free survival (reline: 92% vs. explant: 67%, P=0.66) (Fig 1).

Conclusions: Graft explant is the most durable repair option for failing AFX devices but has a higher risk of early mortality. Relining of failing AFX devices with a second endograft is a safe alternative for treatment but carries a significant risk of continued sac growth requiring additional reinterventions. Elective remediation for the Endologix AFX device should be considered and at minimum enhanced surveillance protocols should be employed.