Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU)

Abstract

Background and purpose: The recently introduced Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is the third generation of Pipeline flow-diverter devices. It has a new stent-surface modification, which reduces thrombogenicity. We aimed to evaluate clinical and radiographic (safety and efficacy) outcomes of the Pipeline Shield.

Materials and methods: The 30-day and 1-year mortality and morbidity rates and the 6- and 18-month radiographic aneurysm occlusion outcomes for procedures performed between March 2016 and January 2018 were analyzed. 3D-TOF-MRA was used for follow-up.

Results: Forty-four attempted Pipeline Shield procedures were performed for 41 patients with 44 target aneurysms (total of 52 aneurysms treated). A total of 88.5% of devices were inserted in the anterior circulation, and 11.5%, in the posterior circulation; 49/52 (94.2%) aneurysms were saccular; and 1/52 (1.9%) was fusiform. One (1.9%) aneurysm was an iatrogenic pseudoaneurysm, and 1 (1.9%) was a dissecting aneurysm. Seventy-one percent (35/49) of the saccular aneurysms were wide-neck (neck, >4 mm), 34.6% (18/52) were large (≥10 mm), and 3.8% (2/52) were giant (≥25 mm). The mean aneurysm sac maximal diameter was 9.0 mm, and the mean neck width was 5.0 mm. The cumulative mortality and morbidity rates were 2.3% and 6.8% at 1 year, respectively. The adequate occlusion rate was 78.8% at 6 months and 90.3% at 18 months.

Conclusions: In this pragmatic and non-industry-sponsored study, the occlusion rates and safety outcomes were similar to those seen in previously published studies with flow-diverter devices and earlier generation Pipeline Embolization Devices.

© 2019 by American Journal of Neuroradiology.

Figures

Fig 1.

Illustration of Pipeline Shield mechanism and structure. A, Before Pipeline Shield deployment, the blood flow is through both the parent artery and the aneurysm. B, However, after device deployment, the blood flow in the aneurysm is reduced or disrupted. C, A schematic showing the magnified appearance of the braided wires of the Pipeline Shield. D, A 3D illustration of the phosphorylcholine molecule, which is covalently bound onto the bare metal wires in a polymer form, resulting in physiologic imitation of the cell membrane.

Fig 2.

Pipeline Shield case. A, CTA shows a right ICA paraophthalmic segment aneurysm measuring 17 mm in maximal sac diameter before treatment. B, Digital subtraction angiography oblique view shows the aneurysm after treatment with a 5 × 14 mm Pipeline Shield and 7 adjunctive coils. The landing zone (arrow) was selected as shown because the ICA paraophthalmic segment lumen was 5.00 mm in diameter, the ICA posterior communicating artery segment lumen was 4.75 mm in diameter (wider at the infundibulum), and the ICA terminal segment was 5.5 mm in diameter. The nominal maximum diameter of the largest Pipeline Shield is 5.0 mm with a maximum unconstrained diameter of 5.25 mm. C, Different oblique view without subtraction after treatment. The Pipeline Shield (arrows) has a flared appearance as it bulges into the infundibulum of the ICA posterior communicating artery segment. D, MR imaging at 5 months postprocedure shows that the aneurysm cross-sectional diameter had increased during the 5-month interval from 17 to 32 mm. The stent was no longer covering the entire aneurysm neck in the ICA paraophthalmic segment. E and F, The aneurysm was re-treated by telescoping a larger-diameter flow-diverter device (FRED, MicroVention; arrows show proximal and distal markers), measuring 5.5 × 14 mm, through the Pipeline Shield, across the small segment of uncovered neck, and landing the stent in the ICA terminal segment. Anesthetic equipment is superimposed over the image.