802 First United States Experience with Pipeline Flex with Shield Technology for Treatment of Intracranial Aneurysms

Abstract

INTRODUCTION: Pipeline Flex with Shield technology (PED-Shield) is a third generation flow-diverter. A surface modification of the mesh with phosphorylcholine covalently bound to the metal struts aims to reduce thrombogenicity. In this study, we report the first United-States series of patients treated with the PED-Shield. METHODS: Information for the first 10 patients with intracranial aneurysms treated with PED-Shield was retrospectively collected. Patients were started on dual antiplatelet therapy (DAPT; 325 mg of aspirin and 75 mg of clopidogrel or 180 mg of ticagrelor) 7-days prior to intervention. After procedure, all patients were discharged on DAPT and planned to switch to aspirin alone at 6 months. RESULTS: Ten patients with 11 intracranial wide-necked aneurysms underwent treatment with PED-Shield between June 2021 and July 2021. The mean age of patients was 64.7 (45 - 86), and nine were female. All aneurysms were unruptured and located in the anterior-circulation. Mean maximum aneurysm diameter was 4.86mm, mean neck width was 3.05mm. Regarding morphology, all aneurysms were saccular except for one, which was fusiform. In one case, the device demonstrated insufficient distal opening, which was repaired with balloon angioplasty. There were no other technical issues or intraoperative complications. We observed no endoleak after deployment of the devices. There were two complications in the post-operative period: one patient had a groin hematoma, which was attributed to failure of the closure device and successfully managed with no clinical repercussions; one patient experienced an asymptomatic distal small intraparenchymal hematoma and trace subarachnoid hemorrhage on post-procedure non-contrast CT, which remained stable over several days. None of the patients experienced transient ischemic attacks or strokes. All patients were discharged in stable condition and unchanged functional status. CONCLUSIONS: In our initial experience with PED-Shield for the treatment of intracranial aneurysms, the device demonstrated excellent performance and no major complications. Further studies are needed to evaluate long term follow-up and safety of different antiplatelet regimens.