BACKGROUND AND OBJECTIVES: Pediatric intracranial aneurysms are rare and often exhibit complex morphologies not amenable to conventional microsurgical reconstruction or endovascular embolization. The Pipeline Embolization Device (PED) is an alternative endovascular treatment of these lesions; however, this device is not approved by the US Food and Drug Administration for use in children due to limited data. Here, we investigated the safety and efficacy of the PED in the pediatric population and compared these outcomes with those in adult populations to expand the current literature in using this device in children. METHODS: A systematic literature review of the PubMed database was performed to identify studies describing the PED in children (18 years or younger). The authors' institutional experience with the device in children was included. Basic analyses of the pediatric cohort were performed. Comparative analyses of safety and efficacy outcomes were conducted between the pediatric cohort and previous adult studies. RESULTS: A total of 114 pediatric patients with 120 intracranial aneurysms were included. Six previous adult studies provided 2098 patients with 2393 aneurysms. There were no significant differences in major complications or neurologic mortality between populations. Pediatric patients were more likely to develop asymptomatic in-stent stenosis (4.2% vs 1.1%, P = .005) and asymptomatic in-stent thrombosis (3.4% vs 0.2%, P < .001). Complete aneurysm occlusion was higher in children on follow-up angiography (92.0% vs 76.7%, P < .001). The incidence rates of major complications and neurologic mortality per patient-month at risk were similar between populations. CONCLUSION: In this study, we found that off-label use of the PED for pediatric intracranial aneurysms has an overall similar safety profile, yet improved efficacy outcome compared with on-label use in adults. These data may help lay the foundation for approval of the PED in treating pediatric intracranial aneurysms.
Cuoco et al. (2026) studied this question.