Pipeline Flex embolisation device with Shield Technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes.

Abstract

The Pipeline Flex embolisation device with Shield Technology (Pipeline Shield) is a novel flow diverter which reduces intra-vessel thrombogenicity. This study summarises periprocedural outcomes and 6-month follow-up results following its introduction in a tertiary interventional neuroradiology centre. This prospective, single-arm study assessed 32 aneurysms treated over a 21-month time period from the time of procedure to 6 months post-procedure. Data collected included patient demographics, aneurysm features and intraprocedural and 6-month post-procedural complications. The mean age of the cohort was 58.8 ± Standard Deviation 8.5 years. Twenty-eight aneurysms were treated electively and four acutely. The elective cases received dual antiplatelet therapy post-procedure. The acute cases received single antiplatelet therapy post-procedure. Of the target aneurysms, 16/32 (50%) were small (<10 mm), 13/32 (41%) were large (10-25 mm) and 3/32 (9%) were giant (≥25 mm). There was no mortality in the series. There were two periprocedural complications (2/32, 6.2%): a stroke and a dissection. There were no post-procedural complications. At 6 months post-procedure, satisfactory occlusion (defined as Raymond-Roy 1 or 2) was achieved in 90.6% and 93.8% by way of magnetic resonance angiography and digital subtraction angiography assessment, respectively. There was no implant migration, no significant intraluminal hyperplasia or in-stent stenosis and no cases of aneurysm recurrence. The Pipeline Shield has an excellent 6- month safety profile with an acceptable rate of intraprocedural complications, no post-procedure complications and no mortality in this case series of 32 acute and elective cases.