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  • Safety and efficacy of the Derivo Embolization Device for the treatment of unruptured intracranial aneurysms: a multicentric study

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New Devices
Original research
Safety and efficacy of the Derivo Embolization Device for the treatment of unruptured intracranial aneurysms: a multicentric study
  1. Bastian Kraus1,
  2. Lukas Goertz2,
  3. Bernd Turowski1,
  4. Jan Borggrefe3,
  5. Marc Schlamann3,
  6. Franziska Dorn4,
  7. Christoph Kabbasch3
  1. 1 Department of Neuroradiology, University Hospital of Duesseldorf, Duesseldorf, Germany
  2. 2 Center for Neurosurgery, University Hospital of Cologne, Cologne, Germany
  3. 3 Department of Neuroradiology, University Hospital of Cologne, Cologne, Germany
  4. 4 Department of Neuroradiology, University Hospital of Munich, Munich, Germany
  1. Correspondence to Dr Lukas Goertz, Center for Neurosurgery, University Hospital of Cologne, Cologne 50937, Germany; lukas.goertz{at}uk-koeln.de

Abstract

Background The Derivo Embolization Device (DED) is a novel flow diverter stent that provides increased x-ray visibility, an improved delivery system, and potentially reduced thrombogenicity. The objective of this study was to evaluate the early safety and efficacy of the second-generation DED.

Methods We retrospectively analyzed all patients with unruptured intracranial aneurysms (UIAs) treated with the DED between November 2015 and December 2017 in three German tertiary care centers. Procedural details, complications, and morbidity within 30 days after treatment, as well as the aneurysm occlusion rates after 6 months (O’Kelly–Marotta scale, OKM), were evaluated.

Results Implantation of the DED was attempted in 42 patients with 42 aneurysms. All procedures were technically successful. Multiple DEDs were used in three aneurysms (7.2%) and adjunctive coiling in 11 (26.2%). Procedure-related complications occurred in four cases (9.5%) including three thromboembolic events and one aneurysm perforation. The morbidity rate was 2.4% and there was no mortality. One patient suffered an ischemic stroke with persistent aphasia at 30-day follow-up due to a thromboembolic infarct (modified Rankin Scale score 1). Among 33 patients (78.6%) available for angiographic follow-up, complete (OKM D) and favorable (OKM C+D) aneurysm occlusion was obtained in 72.7% (24/33) and 87.9% (29/33), respectively.

Conclusions Endovascular treatment of UIAs with the DED is associated with high procedural safety and adequate occlusion rates. Examinations at 1- and 2-year follow-up will provide data on the long-term safety and angiographic outcomes of this device.

  • aneurysm
  • angiography
  • device
  • flow diverter
  • intervention

https://doi.org/10.1136/neurintsurg-2018-013963

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    Footnotes

    • FD and CK contributed equally.

    • BK and LG contributed equally.

    • Contributors BK, BT, JB, MS, FD and CK acquired the data. LG, BK and CK analyzed the data and drafted the manuscript. CK and FD developed the project. All authors revised the paper critically for important intellectual content and provided final approval of the version published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. BK and LG contributed equally as first authors. FD and CK contributed equally as last authors.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests FD and CK serve as consultants for Acandis.

    • Patient consent Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement All data will be made available upon request in an anonymized manner.