Safety and efficacy of the Derivo Embolization Device for the treatment of ruptured intracranial aneurysms.


Journal

Journal of neurointerventional surgery
ISSN: 1759-8486
Titre abrégé: J Neurointerv Surg
Pays: England
ID NLM: 101517079

Informations de publication

Date de publication:
Mar 2019
Historique:
received: 08 06 2018
revised: 14 07 2018
accepted: 18 07 2018
pubmed: 8 8 2018
medline: 10 4 2019
entrez: 8 8 2018
Statut: ppublish

Résumé

The Derivo Embolization Device (DED) is a novel flow diverter with advanced X-ray visibility, potentially lower thrombogenicity, and an improved delivery system. To evaluate the safety and efficacy of the DED for emergency treatment of ruptured intracranial aneurysms. 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. 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%). 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.

Sections du résumé

BACKGROUND 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 OBJECTIVE
To evaluate the safety and efficacy of the DED for emergency treatment of ruptured intracranial aneurysms.
METHODS 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 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 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.

Identifiants

pubmed: 30082333
pii: neurintsurg-2018-014166
doi: 10.1136/neurintsurg-2018-014166
doi:

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

290-295

Informations de copyright

© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: FD and CK serve as consultants for Acandis GmbH (Pforzheim, Germany). The other authors declare that they have no competing interests.

Auteurs

Lukas Goertz (L)

Center for Neurosurgery, University Hospital of Cologne, Cologne, Germany.

Franziska Dorn (F)

Department of Neuroradiology, University Hospital Munich (LMU), Munich, Germany.

Bastian Kraus (B)

Department of Neuroradiology, University Hospital of Duesseldorf, Duesseldorf, Germany.

Jan Borggrefe (J)

Department of Neuroradiology, University Hospital of Cologne, Cologne, Germany.

Marc Schlamann (M)

Department of Neuroradiology, University Hospital of Cologne, Cologne, Germany.

Robert Forbrig (R)

Department of Neuroradiology, University Hospital Munich (LMU), Munich, Germany.

Bernd Turowski (B)

Department of Neuroradiology, University Hospital of Duesseldorf, Duesseldorf, Germany.

Christoph Kabbasch (C)

Department of Neuroradiology, University Hospital of Cologne, Cologne, Germany.

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