Safety and efficacy of the Derivo Embolization Device for the treatment of ruptured intracranial aneurysms.
Adult
Aged
Aneurysm, Ruptured
/ diagnostic imaging
Cerebral Angiography
/ methods
Embolization, Therapeutic
/ adverse effects
Endovascular Procedures
/ adverse effects
Female
Humans
Intracranial Aneurysm
/ diagnostic imaging
Male
Middle Aged
Pilot Projects
Retrospective Studies
Thrombectomy
/ adverse effects
Thromboembolism
/ surgery
Treatment Outcome
aneurysm
angiography
device
flow diverter
intervention
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
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
290-295Informations 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.