Article Text
Abstract
Background The 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.
Methods The 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.
Results Of 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.
Conclusions The 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-URL http://www.clinicaltrials.gov. Unique identifier: NCT02719522.
- aneurysm
- flow diverter
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Footnotes
Contributors MMG and SL: study concept and design. HR: wrote the manuscript. All authors participated in data collection and analysis, edited the manuscript, and approved the final version.
Funding This study was sponsored by Medtronic, Inc.
Competing interests HR reports consultancy fees and travel to study coordination meeting and grants and personal fees from Medtronic outside of the submitted work. MM-G serves as a proctor and consultant for Medtronic. MH has received honoraria from Microvention, Medtronic Neurovascular, Mentice AB, and Stryker Neurovascular for consulting and proctoring. LS is a consultant for Balt, Microvention, Medtronic, Stryker, and Cerenovus; receives research consultancy fees from Medtronic to attend Steering Committee Meetings. SML receives honoraria from Medtronic in relation to proctoring, speaking, and consulting.
Patient consent for publication Not required.
Ethics approval The study was performed in compliance with the World Medical Association's Declaration of Helsinki. The study protocol was approved by the local ethics committee, where required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement The study data, as well as the study documentation (protocol, statistical analysis plan) are stored in Medtronic repositories and available upon reasonable request.