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  • Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study

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Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study
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  • Published on: 12 July 2017
    No thromboembolic complications after Pipeline Embolization Device with Shield Technology treatment: the possible role of aneurysm size
    • René Aquarius, Postdoctoral researcher Radboud university medical center, Nijmegen, The Netherlands. Department of Neurosurgery.
    • Other Contributors:
      • Antonius Mattheus de Korte, Researcher,
      • Joost de Vries, Neurosurgeon

    To the editor,

    With great interest we read the recent paper by Martinez-Galdámez et al. regarding the periprocedural outcomes and early safety after placement of a Pipeline Embolization Device with Shield Technology (PEDshield) (1). Evaluation of new endovascular devices, such as PEDshield, is of the utmost importance to give future users a chance to objectively review possible benefits for their clinical practice.

    In the study of Martinez-Galdámez et al. 76% of the target aneurysms were small (< 10 mm). It is known that small aneurysms are associated with a lower probability of thromboembolisms and ischemic stroke after flow diverter treatment than large and giant aneurysms (2,3). The size of the treated aneurysms, and not the PEDshield, might therefore explain the lack of thromboembolic complications reported in the study of Martinez-Galdámez et al. Selection bias might thus have led to the conclusion that the early safety of the PEDshield device is warranted.

    Furthermore, it is hard to understand why only 21 out of 50 patients (42%) underwent platelet reactivity testing, especially since the primary outcome measure focused on identifying thromboembolic complications in the territory supplied by the treated artery. To make matters worse: when platelet reactivity tests revealed the presence of hyporesponders, anti-platelet therapy was left unchanged in most cases. If thromboembolic complications do occur in the 6-month and 1-year follow-up of this...

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    Conflict of Interest:
    Joost de Vries
    Research Grants (money paid to institution): Stryker Neurovascular.
    Fee-per-hour consulting: Stryker Neurovascular.

    Other authors have no conflicts of interest.