PED Flex with Shield Technology: a feasible alternative for fusiform MCA aneurysms

[...]the PED Flex with enhanced delivery features has been introduced, and although decreased, thromboembolic complications are still a potential risk.3 In light of this, a new surface modification was applied to the PED Flex known as Shield Technology consisting of a phosphorylcholine layer covalen...

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Bibliographic Details
Published in:Stroke and vascular neurology 2018-09, Vol.3 (3), p.185-188
Main Authors: Agnoletto, Guilherme J., Aguilar-Salinas, Pedro, Santos, Roberta, Sauvageau, Eric, Hanel, Ricardo A.
Format: Article
Language:English
Subjects:
Adult
Aneurysms
Case Report
Cerebrovascular Circulation
Embolic Protection Devices
Endovascular Procedures - instrumentation
Female
Humans
Intracranial Aneurysm - diagnostic imaging
Intracranial Aneurysm - physiopathology
Intracranial Aneurysm - therapy
Medical imaging
Middle Cerebral Artery - diagnostic imaging
Middle Cerebral Artery - physiopathology
Platelet Aggregation Inhibitors - therapeutic use
Prosthesis Design
Stents
Treatment Outcome
Veins & arteries
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Summary:[...]the PED Flex with enhanced delivery features has been introduced, and although decreased, thromboembolic complications are still a potential risk.3 In light of this, a new surface modification was applied to the PED Flex known as Shield Technology consisting of a phosphorylcholine layer covalently bound to its metal braids potentially reducing its thrombogenicity.4 Herein, we report our initial experience using the PED Flex with Shield Technology in the treatment of an unruptured fusiform aneurysm located in the middle cerebral artery (MCA) using dual-antiplatelet therapy. In order to potentially reduce the risk of thromboembolic events and risk of thrombosis of small-size distal MCA, the use of PED Flex with Shield Technology was petitioned and approved as compassionate use by the Food and Drug Administration and our institutional review board. The rate of ischaemic complications using FDs without the phosphorylcholine layer in the MCA has been estimated in up to 16.3% (95% CI 10.1 to 22.6) regardless of size or morphology.5 In small case series, the rate has been reported as high as 43%.6 Despite the lack of a randomised clinical trial comparing 1:1 the PED Shield versus the PED Flex and the fact that results from in vitro and in vivo models cannot be fully extrapolated to human clinical use, the following benefits of this new technology have been demonstrated: In this study, there was no difference in platelet deposition when using aspirin monotherapy (p=0.084) between the PED Shield and PED Flex.8 The PED Shield has a trend of a faster neointimal development (earlier healing response) but similar percentage at 21 days in pig models based on optical coherence tomography (OCT) and histopathological findings compared with the PED Flex.
ISSN:2059-8688
2059-8696
DOI:10.1136/svn-2017-000132