Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

Abstract

BackgroundThe first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.MethodsThe SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.ResultsOf 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.ConclusionsThe findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population.Clinical trial registration-URLhttp://www.clinicaltrials.gov. Unique identifier: NCT02719522.

First multicenter experience using the Silk Vista flow diverter in 60 consecutive intracranial aneurysms: technical aspects

“…In 2020, Rice et al 17 published the results of the large prospective study using the Pipeline Flex embolization device with Shield technology for the treatment of 204 aneurysms. The average of the devices was 1.1, the same as for our series.…”

First Experience of Three Neurovascular Centers With the p64MW-HPC, a Low-Profile Flow Diverter Designed for Proximal Cerebral Vessels With Antithrombotic Coating

“…However, recent studies on the efficacy of the third-generation PED with Shield Technology, a phosphorycholine-based surface coating that mimics the red blood cell's outer membrane and significantly reduces platelet activation, reported even higher rates of early occlusions in up to 79.7% after 6 months ( 33 – 35 ). Considering the central role of platelets for the induction of neo-endothelialization ( 11 ), it appears somewhat conflicting that application of a platelet-inhibitory surface modification on a FDS is associated with enhanced occlusion rates ( 36 ).…”

Treatment of Intracranial Aneurysms Using the New Silk Vista Flow Diverter: Safety Outcomes at Short-Term Follow-Up

“…Recently, novel devices have been introduced several systems have been designed in order to reduce thromboembolic complications, facilitate navigability, improve radial force and radiopacity, including the development of FDs specifically designed for the treatment of aneurysms beyond the Willis Circle (PED Shield, Medtronic, Dublin, Ireland; p48, Phenox GmbH, Bochum, Germany; Silk Vista Baby, Balt Extrusion, Montmorency, France; Fred Junior, MicroVention, Tustin, CA, USA) (15)(16)(17)(18)(19)(20)(21).…”