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

Abstract

ObjectiveTo 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.MethodsClinical 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.ResultsIn 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).ConclusionsThe 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.

Figure 1.

The on-label use of pipeline embolization device (PED) for a giant fusiform aneurysm of the internal carotid artery. (A) Under the roadmap, the Maskman catheter was advanced distal to the aneurysm over a 0.014″ microguidewire. (B) A PED was placed to cover the aneurysm (arrowhead) causing the contrast stagnation intra-aneurysm sac (arrow).

Figure 2.

(A) Frontal view of the right vertebral artery angiogram. (B) Lateral view of the right vertebral artery angiogram. Showing the largest width (circle in A) and height (circle in B) of the fusiform aneurysm.

Figure 3.

A 57-year-old male presented with subarachnoid hemorrhage caused by a BBA. (A) 3D reconstruction of the left internal carotid artery angiogram showing the BBA (arrow). (B) Unsubtracted image showing the PED was placed (arrow). (C) The lateral view of the left angiogram after coiling and PED placement showing complete obliteration of the BBA (arrow).

Figure 4.

An 81-year-old female presented with subarachnoid hemorrhage caused by an aneurysm of the internal carotid artery involving the fetal-type posterior communicating artery. (A) 3D reconstruction of the left internal carotid artery angiogram showing the aneurysm involving the fetal-type posterior communicating artery (arrow). (B) Unsubtracted image showing the pipeline embolization device (PED) was placed with additional coils (arrow). (C) The lateral view of the left angiogram after coiling and PED placement showing incomplete obliteration of the aneurysm with a patent posterior communicating artery (arrow). (D) Control angiogram at 6 months follow-up showing complete occlusion of the aneurysm and the posterior communicating artery. The patient was asymptomatic.

Figure 5.

A 54-year-old female presented with an unruptured aneurysm at the M1 segment of the middle cerebral artery involving the lenticulostriate perforating artery. (A) The frontal view of the left internal carotid artery angiogram showing the aneurysm involving the lenticulostriate perforating artery (arrow). (B) The frontal view of the left internal carotid artery angiogram after pipeline embolization device (PED) placement showing the contrast stagnation intra-aneurysm sac with the patent lenticulostriate perforating artery (arrow). (C) Control angiogram at 6 months follow-up showing complete occlusion of the aneurysm and the patent lenticulostriate perforating artery. The patient was asymptomatic.

Figure 6.

The violin plot for the continuous variable of the age distributions in procedure-related complications, aneurysm occlusion, and mortality rate.

Figure 7.

The spine plots for category variables in procedure-related complications, aneurysm occlusion, and mortality rate, where the height shows the proportion and the width shows the frequency, and the texts marked in the figures are “frequency, percentage.” (A) Patient's sex, (B) aneurysm size, (C) rupture and unruptured aneurysms, (D) aneurysm morphology; (E) patients with anterior circulation and posterior circulation aneurysms; (F) distal arterial and arterial trunk aneurysms.