Thromboembolic complications after treatment with the INCRAFT abdominal aortic aneurysm ultra-low-profile stent graft system.

Abstract

Objective: Low-profile endografts have reported increased rates of limb graft occlusions. The INCRAFT stent graft system is an ultra-low-profile endograft for the exclusion of infrarenal abdominal aortic aneurysms. Our aim was to report thromboembolic events (TEs) in patients treated with the INCRAFT device and its association with risk factors.

Methods: A retrospective study was performed of 80 patients treated with the INCRAFT endograft between February 2015 and December 2022 at a single institution. All available imaging studies were reviewed by two reviewers independently. TEs included intraprosthetic thrombus (IPT), limb graft occlusion (LGO), and distal embolization. A regression analysis was performed to evaluate possible risk factors associated with the development of TEs. These included tortuous access vessels, IPT, access vessel diameter, and the ratio between the cross-sectional area of the main body to the bilateral limb grafts.

Results: Limb occlusions occurred in seven patients (9%) and 12 limbs (7.5%), resulting in a primary and secondary patency at 1, 3, and 5 years of 96% and 99%, 94% and 97%, and 89% and 93%, respectively. IPT was found in 36% of patients and affected endograft limbs in 93%. Ten distal occlusions in eight patients (10.0%) were considered to originate from IPT, which led to symptomatic occlusions of below-the-knee vessels in all patients. Freedom from IPT at 1, 3, and 4 years was 80%, 61%, and 43%, respectively. Age ≤70 years and access vessel diameter ≥10 mm were associated with IPT development. IPT was significantly associated with LGO (odds ratio, 77.10; P = .003).

Conclusions: Thromboembolic events are frequent after treatment with the INCRAFT endograft with a LGO rate of 9% per patient and IPT found in 36% of patients. IPT was more common in patients ≤70 years and was a significant risk factor for LGO.