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Improved Turnaround Times | Median time to first decision: 12 days

Research ArticleNeurointervention
Open Access

European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study

M. Killer-Oberpfalzer, N. Kocer, C.J. Griessenauer, H. Janssen, T. Engelhorn, M. Holtmannspötter, J.H. Buhk, T. Finkenzeller, G. Fesl, J. Trenkler, W. Reith, A. Berlis, K. Hausegger, M. Augustin, C. Islak, B. Minnich and M. Möhlenbruch
American Journal of Neuroradiology March 2018, DOI: https://doi.org/10.3174/ajnr.A5592
M. Killer-Oberpfalzer
aFrom the Research Institute of Neurointervention/Department of Neurology (M.K.-O., C.J.G.), Paracelsus Medical University, Salzburg, Austria
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  • ORCID record for M. Killer-Oberpfalzer
N. Kocer
bDepartment of Neuroradiology (N.K., C.I.), Cerrahpasa Medical School, Istanbul University, Turkey
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C.J. Griessenauer
aFrom the Research Institute of Neurointervention/Department of Neurology (M.K.-O., C.J.G.), Paracelsus Medical University, Salzburg, Austria
cDepartment of Neurosurgery (C.J.G.), Geisinger Health, Danville, Pennsylvania
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  • ORCID record for C.J. Griessenauer
H. Janssen
dInstitute of Radiology and Neuroradiology (H.J., T.F.), Klinikum Nuernberg Sued, Paracelsus Medical University, Nuernberg, Germany
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T. Engelhorn
eDepartment of Neuroradiology (T.E.), University Hospital, Erlangen, Germany
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M. Holtmannspötter
fDepartment of Diagnostic Radiology (M.H.), Rigshospitalet, Copenhagen, Denmark
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J.H. Buhk
gDepartment of Neuroradiology (J.H.B.), University Hospital Hamburg, Eppendorf, Germany
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T. Finkenzeller
dInstitute of Radiology and Neuroradiology (H.J., T.F.), Klinikum Nuernberg Sued, Paracelsus Medical University, Nuernberg, Germany
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G. Fesl
hDepartment of Neuroradiology (G.F.), Klinikum Grosshadern, University of Munich, Munich, Germany
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J. Trenkler
iDepartment of Neuroradiology (J.T.), Kepler Universitätsklinikum, Linz, Austria
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W. Reith
jKlinik für Diagnostische und Interventionelle Neuroradiologie (W.R.), Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
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A. Berlis
kKlinik für Diagnostische Radiologie und Neuroradiologie (A.B.), Klinikum Augsburg, Augsburg, Germany
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K. Hausegger
lDepartment of Diagnostic and Interventional Radiology (K.H.), Klinikum Klagenfurt, Klagenfurt, Austria
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M. Augustin
mDepartment of Radiology (M.A.), University Hospital, Graz, Austria
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C. Islak
bDepartment of Neuroradiology (N.K., C.I.), Cerrahpasa Medical School, Istanbul University, Turkey
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B. Minnich
nDepartment of Cell Biology and Physiology (B.M.), Universität Salzburg, Salzburg, Austria
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M. Möhlenbruch
oDepartment of Neuroradiology (M.M.), Universitätsklinikum Heidelberg, Heidelberg, Germany.
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Article Figures & Data

Tables

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    Table 1:

    Baseline characteristics

    Characteristics
    No. of aneurysms579
    No. of patients531
    No. of procedures534
    Patient demographics
        Male (No.)147 (27.7%)
        Female (No.)384 (72.3%)
        Age at time of treatment (median) (range) (yr)54 (13–86)
    Presentation of patients (No.)
        Incidental249 (46.9%)
        Headaches98 (18.4%)
        Cranial nerve palsy37 (7%)
        Recanalization of previously treated aneurysm58 (10.9%)
        Subarachnoid hemorrhage65 (12.2%)
            Acute (≤3 days)41 (7.7%)
        Stroke20 (3.8%)
        Other4 (0.8%)
    Patients with multiple aneurysms (No.)141 (26.6%)
        Aneurysms per patient (median) (range)1 (1–5)
        Patients with a single aneurysm390 (73.5%)
        Patients with 2 aneurysms101 (19%)
        Patients with 3 aneurysms30 (5.7%)
        Patients with 4 aneurysms8 (1.5%)
        Patients with 5 aneurysms2 (0.3%)
    Pretreatment mRS (per patient) (No.)
        0–2525 (98.8%)
        3–56 (1.2%)
    Aneurysm characteristics (No.)
        Left272 (47.0%)
        Right257 (44.4%)
        Midline50 (8.6%)
    Anterior circulation (No.)
        Internal carotid artery
            Posterior communicating50 (8.6%)
            Paraophthalmic270 (46.6%)
            Cavernous45 (7.8%)
            Other67 (11.5%)
        Middle cerebral artery37 (6.4%)
        Anterior cerebral artery16 (2.7%)
        Anterior communicating artery4 (0.9%)
        Pericallosal artery13 (2.2%)
    Posterior circulation (No.)36 (6.2%)
        Basilar artery30 (5.2%)
        Posterior cerebral artery9 (1.6%)
        Superior cerebellar artery2 (0.3%)
    Aneurysm morphology (No.)
        Saccular
            Sidewall459 (79.2%)
            Bifurcation63 (10.9%)
        Fusiform/dissecting/blister
            Fusiform27 (4.7%)
            Dissecting20 (3.5%)
            Blister10 (1.7%)
    Maximal diameter (median) (range) (mm)7.6 (1–36.6)
    Neck diameter (median) (range) (mm)4.5 (1–30)
    • View popup
    Table 2:

    Complications and adverse events per procedure

    Periprocedural (In-Hospital Stay) (No.)During Follow-Up (after Hospital Discharge) (No.)
    Complications
        Spontaneous rupture of the FRED-treated aneurysm02
        Spontaneous nonaneurysmal intracranial hemorrhage31
        Symptomatic ischemic stroke
            Minor (≤1 mo)85
            Major (>1 mo)21
        Stent/parent artery stenosis53
        Stent/parent artery occlusion48
        Permanent cranial neuropathy00
        Other complications
            Groin hematoma1
            Dissection1
            Aneurysm growth2
        Total24 (4.5%)22 (4.1%)
    Adverse events
        Detachment in the hub of the microcatheter2
        Poor opening on deployment10
        Torquing of stent on deployment1
        Multiple repositioning2
        Visible gap between inner and outer stent1
        Fish mouthing of the distal stent end13
        Total15 (2.8%)14 (2.6%)
    Transient morbidity (≤90 days)10 (1.9%)7 (1.3%)
    Permanent morbidity (>90 days)3 (0.6%)1 (0.2%)
    Mortality4 (0.75%)4 (0.75%)
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European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study
M. Killer-Oberpfalzer, N. Kocer, C.J. Griessenauer, H. Janssen, T. Engelhorn, M. Holtmannspötter, J.H. Buhk, T. Finkenzeller, G. Fesl, J. Trenkler, W. Reith, A. Berlis, K. Hausegger, M. Augustin, C. Islak, B. Minnich, M. Möhlenbruch
American Journal of Neuroradiology Mar 2018, DOI: 10.3174/ajnr.A5592
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  • Flow diverter stents for endovascular treatment of aneurysms: a comparative study of efficacy and safety between FREDX and FRED
  • Flow diversion for compressive unruptured internal carotid artery aneurysms with neuro-ophthalmological symptoms: a systematic review and meta-analysis
  • Flow diversion for compressive unruptured internal carotid artery aneurysms with neuro-ophthalmological symptoms: a systematic review and meta-analysis
  • The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology--First Multicenter Experience in 161 Patients
  • Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial
  • Evaluation of a novel flow diverter, the DiVeRt system, in an animal model
  • Derivo embolization device in the treatment of unruptured intracranial aneurysms: a prospective multicenter study
  • Comparison of PED and FRED flow diverters for posterior circulation aneurysms: a propensity score matched cohort study
  • Review of current intracranial aneurysm flow diversion technology and clinical use
  • Treatment of Ruptured Blister-Like Aneurysms with the FRED Flow Diverter: A Multicenter Experience
  • Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms
  • The FRED for Cerebral Aneurysms of the Posterior Circulation: A Subgroup Analysis of the EuFRED Registry
  • On Flow Diversion: The Changing Landscape of Intracerebral Aneurysm Management
  • SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results
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M. Killer-Oberpfalzer, N. Kocer, C.J. Griessenauer, H. Janssen, T. Engelhorn, M. Holtmannspötter, J.H. Buhk, T. Finkenzeller, G. Fesl, J. Trenkler, W. Reith, A. Berlis, K. Hausegger, M. Augustin, C. Islak, B. Minnich, M. Möhlenbruch
European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study
American Journal of Neuroradiology Mar 2018, DOI: 10.3174/ajnr.A5592

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