Type IA Endoleak Correction With Fenestrated Devices After EVAR: Outcomes and Predictors of Secondary Failure.

Abstract

Purpose: The aim of this study was to review the results of fenestrated stent-graft (Fenestrated Endovascular Aortic Repair [FEVAR]) implantation to treat patients with type IA endoleaks after prior infrarenal endovascular aortic repair (EVAR).

Methods: A retrospective single-center analysis of prospectively collected data was conducted, including consecutive patients who underwent FEVAR to correct a type IA endoleak between November 2009 and April 2021. All devices were manufactured by Cook Medical (INC, Bloomington, Indiana). Demographic details, anatomical features, fenestrated stent-graft configuration, technical success, and major adverse events (MAEs) were recorded according to current SVS standards. The primary endpoint was freedom-from-significant aneurysm sac expansion (≥5 mm) and survival according to the Kaplan-Meier analysis. Secondary endpoints included 30-day outcomes, freedom-from-all-cause mortality, and aortic-related secondary interventions. Multivariate Cox regression was performed to identify factors associated with the study endpoints.

Results: Overall, 47 patients (89% male, median age 80) were included. Median time from initial EVAR was 60 months [41-72]. Median pre-FEVAR maximal aneurysm diameter was 68mm [62-79]. Median fluoroscopy time and dose area product were, respectively, 49 min [36-63] and 66 Gy.cm² [38-101]. Technical success rate was 96% with no 30-day deaths reported. Two (4.3%) renal MAE occurred. Median follow-up was 22 months [12-36]. Two-year freedom-from-aneurysm sac expansion and aortic-related secondary intervention were 80% [66-96] and 69% [55-87], respectively. From the multivariate analysis, the configuration of the fenestrated device was not predictive of aneurysm sac expansion, whereas only the preoperative aneurysm maximal diameter was an independent predictor (hazard ratio [HR] [per 1 mm increment]=1.05 [1.01-1.10]; p=0.016) and was associated with a higher risk of aortic-related secondary intervention (HR [per 1 mm increment]=1.07 [1.02-1.12]; p=0.006). Other predictors of aortic-related secondary intervention were pre-existing type IB or III endoleak (HR=7.89 [1.39-44.8]; p=0.020) and aortic degeneration above the primary EVAR (HR=16.6 [1.88-147], p=0.011).

Conclusion: Late type IA endoleak after EVAR can be treated safely with a fenestrated stent-graft; preoperative maximum aneurysm diameter is associated with an increased risk of later aneurysm sac growth. Close follow-up is mandatory in this subgroup of patients given the high reintervention rate.

Clinical impact: Type IA endoleak following endovascular aneurysm repair (EVAR) can be treated using a fenestrated stent-graft (FEVAR). Treatment options include the addition of a fenestrated cuff alone or complete relining of the previous graft with either a 3-component device or a unibody bifurcated FEVAR. Regardless of the device configuration the treatment appears to be safe but remains associated with high rates of reintervention and aneurysm growth. Although no significant differences have been observed in long-term outcomes, a complete relining with a bifurcated FEVAR may be preferred as a first-line approach, as it offers the advantage of addressing occult associated Type III endoleaks and reducing the risk of component disconnection.