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.

Vanguard Study: Initial experience with the new fourth generation Pipeline Vantage Flow Diverter (PVFD): 6-month results, technical and clinical considerations

“…The SCOPE-AUS study, which investigated the use of the PED device with Shield technology, reported complete aneurysm occlusion rates of 78.5% at 6 months and 92.5% (233/252) at 18 months or at last follow-up imaging, while the combined long-term neurologic morbidity and mortality occurred in 5% (12/238) of patients, with nine (3.8%) neurologic morbidities and three (1.3%) neurologic mortalities. 11 The authors also reported successful stent deployment in 97.3% (285/293) without the need for adjuvant balloon angioplasty. 11 In a separate study, Rice et al demonstrated high rates of complete occlusion (70.8% and 77.2% at 6 months and 1 year, respectively) and low rates of retreatment (0.05%) among subjects treated with the PED-Shield in the SHIELD study, while the morbidity and mortality rates were 3% and 1%, respectively.…”

“…11 The authors also reported successful stent deployment in 97.3% (285/293) without the need for adjuvant balloon angioplasty. 11 In a separate study, Rice et al demonstrated high rates of complete occlusion (70.8% and 77.2% at 6 months and 1 year, respectively) and low rates of retreatment (0.05%) among subjects treated with the PED-Shield in the SHIELD study, while the morbidity and mortality rates were 3% and 1%, respectively. 5 In addition, Trivelato et al reported 79.7% aneurysm occlusion at 6 months and 85.3% at 12 months, with a periprocedural complication rate of 7.3% among 151 patients with a total of 182 aneurysms treated with the PED-Shield.…”

Comparison of Thromboembolic Events Between Pipeline Embolization Device (PED) Shield and PED/PED Flex: A Propensity Score–Matched Analysis

“…This has also been reported in other cohorts reporting complete occlusion rates ranging from 70% to 90% in the mid and long term. 11,12,14,[19][20][21][22][23] A current landscape that is still a matter of debate concerns the safety profile of early discontinuation of DAPT or upfront aspirin monotherapy for patients treated with PED Shield. 18,24,31,32 Interestingly, in a small case series that included 14 patients with acute aneurysmal subarachnoid hemorrhage treated with Shield technology and aspirin monotherapy, only 1 case of instent thrombosis was reported, and it occurred the day after the procedure.…”

“…This leads to decreased platelet activation, proven in both in vitro and animal studies. 7,8 Since its Food and Drug Administration approval in 2021, many studies have evaluated the real-world safety and efficacy of PED with Shield technology, [9][10][11][12][13] However, there remains a paucity of literature comparing PED Shield to its predecessors, PED first-generation and PED Flex, which lack this surface modification. In our institution, PED with Shield technology was introduced in 2021 and, since then, has been the most common FD used in our practice.…”

Letter: Commentary: The Pennsylvania Postmarket Multicenter Experience With Flow Redirection Endoluminal Device

“…5,6 These refinements encompassed incessant technical modifications such as introducing new endoluminal devices, establishing intrasaccular flow divertors with the Woven EndoBridge (MicroVention Inc) being the prodigy of these devices, 7,8 and surface modifications feature of the existing devices such as Pipeline Embolization Device (PED) (Medtronic) Shield and the FRED-X devices. While large multicenter experiences are currently lacking from the United States, it is worth noting that thromboembolic rates reported from 3 international multicenter studies using the PED Shield (6.4%, 9 3.3%, 10 2.5% 11 ) were not different from earlier studies using prior PED versions (eg, Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device 2.1% 12 and IntrePED 3.3% 13 ). Concurrently to the PED Shield, the FRED-X device features a similar nanopolymer surface modification aiming to reduce device thrombogenicity.…”