ARTICLE HIGHLIGHTS:
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Type of Research: Retrospective comparison between a single-center prospectively maintained database cohort and an IDE trial cohort.
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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.
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Take Home Message: Prophylactic perigraft sac embolization proves to be safe and effective in the prevention of type II endoleak and sac expansion.
Abstract
Background
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.
Methods
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).
Results
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].
Conclusion
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.
Keywords
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Article info
Publication history
Accepted:
February 27,
2023
Received in revised form:
February 23,
2023
Received:
February 3,
2023
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
Published by Elsevier Inc.
