First U.S. Experience Using the Pipeline Flex Embolization Device with Shield Technology for Treatment of Intracranial Aneurysms.

BACKGROUND: The Pipeline Flex Embolization Device with Shield technology (PED-Shield [Medtronic, Dublin, Ireland]) is a third-generation flow diverter. Surface modification of the mesh with phosphorylcholine covalently bound to the metal struts aims to reduce thrombogenicity. In the present study, we report the results from the first U.S. series of patients with intracranial aneurysms treated with the PED-Shield and a comprehensive systematic literature review.

METHODS: We retrospectively collected the patient demographics, aneurysm characteristics, procedural details, and periprocedural complications from our prospectively maintained endovascular database (April 2021 to July 2021). Our literature review encompassed 3 databases (PubMed, Embase, and MEDLINE).

RESULTS: Ten patients with 11 anterior circulation unruptured wide-necked aneurysms (10 saccular, 1 fusiform) were included. The average patient age was 64.7 years (range, 45-86 years), and 9 were women. One device demonstrated insufficient distal opening. No other technical issues or intraprocedural complications had occurred. After the procedure, 1 patient had developed a groin hematoma and 1 had experienced a small intracranial hemorrhage, with no clinical repercussions. All patients were discharged with dual-antiplatelet therapy. In the review, we identified 15 studies. Most had been conducted in Europe and South America and 3 were U.S. case reports of compassionate use of the device.

CONCLUSIONS: In our initial periprocedural experience with the PED-Shield for intracranial aneurysm treatment, the device demonstrated an excellent performance and no major complications. Further studies are required to evaluate the long-term follow-up results and the safety of different antiplatelet regimens.