Type of Research: Retrospective comparison between a single-center prospectively maintained database cohort and an IDE trial cohort.
Key Findings: In this study including patient who underwent EVAR with the Ovation stent graft, the use of prophylactic perigraft sac embolization was associated with a significant reduction in the incidence of type II endoleak and sac expansion.
Take Home Message: Prophylactic perigraft sac embolization proves to be safe and effective in the prevention of type II endoleak and sac expansion.
Type II endoleaks (ELII) are the most common complication following endovascular aneurysm repair (EVAR). Persistent type II endoleaks require continual surveillance and have been shown to increase the risk of Type I and III endoleaks, sac growth, need for intervention, conversion to open or even rupture directly or indirectly. These are often difficult to treat following EVAR and there are limited data regarding the effectiveness of prophylactic treatment of ELII. The aim of this study is to report midterm outcomes of prophylactic perigraft arterial sac embolization (pPASE) performed in patients undergoing EVAR.
This is a comparison of two elective cohorts of those undergoing EVAR using the Ovation stent graft with and without prophylactic branch vessel and sac embolization. Patients who underwent pPASE at our institution had data collected in a prospective, IRB approved database. These were compared against the core lab adjudicated data from the Ovation IDE trial. Prophylactic PASE was performed at the time of EVAR with thrombin, contrast and gelfoam if lumbar or mesenteric arteries were patent. Endpoints included freedom from ELII, reintervention, sac growth, all-cause mortality (ACM) and aneurysm-related mortality (ARM).
Thirty-six patients (13.1%) underwent pPASE, while 238 patients (86.9%) had standard EVAR. Median follow-up was 56 months (IQR 33-60). The 4-year freedom from ELII estimates were 84% for the pPASE vs 50.7% for the standard EVAR group (P=0.0002). All aneurysms in the pPASE group remained stable in size or demonstrated regression, whereas aneurysm sac expansion was seen in 10.9% of the standard EVAR group, P=0.03. At 4 years, mean AAA diameter decreased by 11mm (95% CI 8-15) in the pPASE group vs 5mm (95%CI 4-6) for the standard EVAR group, P=0.0005. There were no differences in the 4-year freedom from ACM and ARM. However, the difference in reintervention for ELII trended toward significance (0.0% vs 10.7%, P=0.1). On multivariable analysis, pPASE was associated with a 76% reduction in ELII [aHR(95%CI): 0.24 (0.08-0.65), P=0.005].
These results suggest that pPASE in those undergoing EVAR is safe and effective in the prevention of EII and significantly improves sac regression over standard EVAR while minimizing the need for reintervention.
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Accepted: February 27, 2023
Received in revised form: February 23, 2023
Received: February 3, 2023
Publication stageIn Press Journal Pre-Proof
Published by Elsevier Inc.