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PT  - JOURNAL ARTICLE
AU  - Atasoy, D.
AU  - Kandasamy, N.
AU  - Hart, J.
AU  - Lynch, J.
AU  - Yang, S.-H.
AU  - Walsh, D.
AU  - Tolias, C.
AU  - Booth, T.C.
TI  - Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU)
AID  - 10.3174/ajnr.A6314
DP  - 2019 Dec 01
TA  - American Journal of Neuroradiology
PG  - 2094--2101
VI  - 40
IP  - 12
4099  - http://www.ajnr.org/content/40/12/2094.short
4100  - http://www.ajnr.org/content/40/12/2094.full
SO  - Am. J. Neuroradiol.2019 Dec 01; 40
AB  - 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, &amp;gt;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.