Clinical research study
Abdominal aortic and iliac artery aneurysms
Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data

https://doi.org/10.1016/j.jvs.2019.04.486Get rights and content
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Abstract

Objective

The purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date.

Methods

Patients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak.

Results

Through 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up.

Conclusions

In the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.

Keywords

EVAR
Endovascular
Abdominal aortic aneurysm
ENGAGE
Endoleak
Type II

Cited by (0)

The ENGAGE registry is funded by Medtronic. Data were supplied by Medtronic. The specific study design, data analysis and interpretation, manuscript writing, and decision to submit the manuscript were done by the authors without restrictions.

ClinicalTrials.gov identifier: NCT00870051.

Author conflict of interest: H.J.M.V. is a consultant for Medtronic, W. L. Gore & Associates, Endologix, and Arsenal AAA. J.A.W.T. receives unrestricted research grants from Medtronic, W. L. Gore & Associates, and Cook. A.P. receives ongoing reimbursement from Medtronic and receives speaker honoraria from Cook and Medtronic. D.B. is a consultant for Medtronic, W. L. Gore & Associates, and Endologix and receives research funding from Medtronic. V.R. is a consultant for CryoLife-JOTEC, iVascular, and Terumo Aortic and receives speaker honoraria from Medtronic. J.-P.B. receives honoraria from Medtronic. M.M.P.J.R. is a consultant for Terumo Aortic, Bentley, and Endologix.

The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest.