Safety and efficacy of the Pipeline Flex embolization device with Shield Technology for the acute treatment of ruptured internal carotid artery pseudoaneurysms: a multi-institution case series
Objective: Ruptured blister, dissecting, and iatrogenic pseudoaneurysms are rare pathologies that pose significant challenges from a treatment standpoint. Endovascular treatment via flow diversion represents an increasingly popular option; however, drawbacks include the requirement for dual antiplatelet therapy and the potential for thromboembolic complications, particularly acute complications in the ruptured setting. The Pipeline Flex embolization device with Shield Technology (PED-Shield) offers reduced material thrombogenicity, which may aid in the treatment of ruptured internal carotid artery pseudoaneurysms.
Methods: The authors conducted a multi-institution, retrospective case series to determine the safety and efficacy of PED-Shield for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. Clinical, radiographic, treatment, and outcomes data were collected.
Results: Thirty-three patients were included in the final analysis. Seventeen underwent placement of a single device, and 16 underwent placement of two devices. No thromboembolic complications occurred. Four patients were maintained on aspirin alone, and all others were treated with long-term dual antiplatelet therapy. Among patients with 3-month follow-up, 93.8% had a modified Rankin Scale score of 0-2. Complete occlusion at follow-up was observed in 82.6% of patients.
Conclusions: PED-Shield represents a new option for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. The reduced material thrombogenicity appeared to improve the safety of the PED-Shield device, as this series demonstrated no thromboembolic complications even among patients treated with only single antiplatelet therapy. The efficacy of PED-Shield reported in this series, particularly with placement of two devices, demonstrates its potential as a first-line treatment option for these pathologies.
Bounajem, M. T., Joyce, E., Scoville, J. P., Seinfeld, J., Hoffman, J., Grossberg, J. A., Waiters, V., White, A. C., Nerva, J., Burkhardt, J. K., Tonetti, D. A., El Naamani, K., Gooch, M. R., Jabbour, P., Tjoumakaris, S., Ortega Gutierrez, S., Levitt, M. R., Lang, M., Ares, W. J., Desai, S., … Grandhi, R. (2023). Safety and efficacy of the Pipeline Flex embolization device with Shield Technology for the acute treatment of ruptured internal carotid artery pseudoaneurysms: a multi-institution case series. Neurosurgical focus, 54(5), E4. https://doi.org/10.3171/2023.2.FOCUS233