Safety and Clinical Effectiveness of Pipeline Shield Device for Intracranial Aneurysms in an Australian Cohort (SCOPE‐AUS)

Abstract

Background: The Pipeline Flex Embolization Device (PED) with Shield Technology (PED-Shield) is a third-generation flow diverting stents with surface modification designed to reduce platelet adhesion and thrombogenicity. We report the long-term safety and effectiveness of the PED-Shield in the treatment of unruptured intracranial aneurysms in an Australian cohort. Methods: SCOPE-AUS (Safety and Clinical Effectiveness Of Pipeline Shield Embolization Device for Treatment of Intracranial Aneurysms in Australia) is a multicenter, single-arm, retrospective study of patients with unruptured intracranial aneurysms treated with the PED-Shield flow diverting stents at 3 high-volume neurointervention centers in Australia between May 1, 2015, and June 30, 2018, evaluating safety and efficacy. The primary outcome was neurologic adverse event or neurologic-related death at 1 year, and the secondary outcome was long-term complete aneurysm occlusion. Results: A total of 238 patients (mean age 55.8±11.0 years, 73.1% [174/238] female) and 278 aneurysms were treated via 247 procedures. Two (0.7%) aneurysms were retreated during the 18-month follow-up. Overall occlusion rates at 18 months or at last follow-up imaging were 92.5% (233/252). There were 35 (14.7%) total primary end point events. The 12-month neurologic morbidity and mortality rates were 3.8% (9/238) and 1.3% (3/238), respectively. For the subgroup of internal carotid artery aneurysms, mortality (0.7%) and morbidity (2.0%) rates were low, and the complete occlusion rate was 92.5% (147/155). Conclusions: In this multicenter study, which includes a wide variety of both distal bifurcation and proximal unruptured intracranial aneurysms, the occlusion rates and safety outcomes of the PED-Shield flow diverting stent demonstrate a high proportion of complete aneurysm occlusion, extremely low retreatment rates, and low complication rates.