The off-label uses of pipeline embolization device for complex cerebral aneurysms: Mid-term follow-up in a single center

Interv Neuroradiol. 2022 Dec 30:15910199221148800. doi: 10.1177/15910199221148800. Online ahead of print.

Abstract

Objective: To describe the off-label uses of pipeline embolization device for a variety of types of aneurysms including ruptured aneurysms, posterior circulation aneurysms, small aneurysms, distal aneurysms, and recurrent aneurysms.

Methods: Clinical and angiographic data of patients who underwent pipeline embolization device treatment on off-label use at our center were retrospectively reviewed. For categorical variables, Fisher's exact test was used, and a two-sample Wilcoxon rank-sum test was used for patients' age to analyze the correlation with outcomes.

Results: In this study, 121 aneurysms in 107 patients received off-label pipeline embolization device treatments. The overall rate of complete aneurysm occlusion was 77.8% (28/36 in 35 patients) for posterior circulation aneurysms and 95.3% (81/85 in 72 patients) for anterior circulation aneurysms. The posterior circulation aneurysms have a lower rate of aneurysm occlusion (p = 0.0372). The small aneurysms have a higher rate of aneurysm occlusion (p = 0.0104). The patient's sex, age, and aneurismal size were associated with ischemic stroke complications (p = 0.0397, 0.0166, and 0.0178). In posterior circulation aneurysm patients, only two basilar apex aneurysms underwent pipeline embolization device treatment, both of whom died of thrombotic complications. There was no difference in mortality between posterior circulation aneurysm patients (8.6%, 3/35) and anterior circulation aneurysm patients (1.4%, 1/72) (p = 0.1015). Patients of older age have a higher risk of death rate (p = 0.0053).

Conclusions: The off-label use of pipeline embolization device is often performed in clinical practice and can achieve efficacy in complex aneurysms. The off-label use of pipeline embolization device was found to carry an increased rate of mortality in older patients. Excluding basilar apex aneurysms, the pipeline embolization device is as safe as anterior circulation aneurysms in the treatment of posterior circulation aneurysms elsewhere.

Keywords: Pipeline embolization device; cerebral aneurysm; endovascular; off-label.