Background Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) has recently been introduced as the third generation of Pipeline flow-diverter devices (FDDs) with a new stent surface modification giving reduced thrombogenicity.
Objective We aimed to evaluate clinical (safety) and radiographic (efficacy) outcomes of the Pipeline Shield.
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 reviewed. 3D-TOF-MRA was used for follow up.
Results A total of 44 attempted Pipeline Shield procedures were performed for 41 patients with 44 target aneurysms (total 52 aneurysms treated). 88.5% were inserted in the anterior circulation and 11.5% the posterior circulation. 49/52 (94.2%) aneurysms were saccular, 1/52 (1.9%) was fusiform. One (1.9%) aneurysm was an iatrogenic pseudoaneurysm and one (1.9%) was a dissecting aneurysm. 71% (35/49) of the saccular aneurysms were wide-necked (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 9.2 mm, and mean neck width was 5.1 mm. The cumulative mortality and morbidity rates were 2.3% and 9.2% 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 independent study, the occlusion rates and safety outcomes were similar to those seen in previously published studies with FDDs and earlier generation PEDs.
Disclosures N. Kandasamy: 6; C; contribution towards institutional study budget. T. Booth: 6; C; institutional study budget support. J. Hart: 6; C; Institutional study budget support. D. Atasoy: None. Y. Shih-hung: None.
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