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New Devices
Original research
Safety and efficacy of the Derivo Embolization Device for the treatment of ruptured intracranial aneurysms
  1. Lukas Goertz1,
  2. Franziska Dorn2,
  3. Bastian Kraus3,
  4. Jan Borggrefe4,
  5. Marc Schlamann4,
  6. Robert Forbrig2,
  7. Bernd Turowski3,
  8. Christoph Kabbasch4
  1. 1 Center for Neurosurgery, University Hospital of Cologne, Cologne, Germany
  2. 2 Department of Neuroradiology, University Hospital Munich (LMU), Munich, Germany
  3. 3 Department of Neuroradiology, University Hospital of Duesseldorf, Duesseldorf, Germany
  4. 4 Department of Neuroradiology, University Hospital of Cologne, Cologne, 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 with advanced X-ray visibility, potentially lower thrombogenicity, and an improved delivery system.

Objective To evaluate the safety and efficacy of the DED for emergency treatment of ruptured intracranial aneurysms.

Methods Between February 2016 and March 2018, 10 patients (median age 54.5 years, seven women) with 11 aneurysms were treated with the DED at three neurovascular centers. Procedural details, complications, morbidity, and aneurysm occlusion (O’Kelly-Marotta scale, OKM) were retrospectively reviewed.

Results Among 11 aneurysms treated, there were nine anterior circulation and two posterior circulation aneurysms. Aneurysm morphology was saccular in four cases, dissecting in three, blister-like in three, and fusiform in one. In each case, a single DED was implanted and deployment was technically successful without exception. Adjunctive coiling was performed in two aneurysms. We observed one in-stent thrombosis, presumably due to low response to clopidogrel 4 days after the procedure, which remained with a mild hemiparesis after aspiration thrombectomy. No further thromboembolic or hemorrhagic events occurred. Favorable outcome (modified Rankin scale score ≤2) at last follow-up was achieved in all patients. Among 10 aneurysms available for angiographic follow-up, complete aneurysm occlusion (OKM D) was obtained in nine cases (90.0%).

Conclusions In this pilot study, endovascular treatment of ruptured intracranial aneurysms with the DED was feasible and not associated with any incidence of rebleeding. Larger series with longer follow-up are warranted to reach a definite conclusion about this device.

  • aneurysm
  • angiography
  • device
  • flow diverter
  • intervention

https://doi.org/10.1136/neurintsurg-2018-014166

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    Footnotes

    • Contributors BK, BT, JB, MS, RF, FD, and CK acquired the data. CK and LG developed the project, analyzed the data, and drafted the manuscript. 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.

    • 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 GmbH (Pforzheim, Germany). The other authors declare that they have no competing interests.

    • Patient consent Not required.

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

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