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Research ArticleINTERVENTIONAL

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

D.F. Vollherbst, H. Lücking, J. DuPlessis, M. Sonnberger, C. Maurer, N. Kocer, M. Killer-Oberpfalzer, R. Rautio, L. Valvassori, A. Berlis, S. Gasser, S. Gatt, A. Dörfler, M. Bendszus and M.A. Möhlenbruch
American Journal of Neuroradiology March 2023, DOI: https://doi.org/10.3174/ajnr.A7834
D.F. Vollherbst
aFrom the Department of Neuroradiology (D.F.V., M.B., M.A.M.), Heidelberg University Hospital, Heidelberg, Germany
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  • ORCID record for D.F. Vollherbst
H. Lücking
bDepartment of Neuroradiology (H.L., A.D.), University of Erlangen-Nuremberg, Erlangen, Germany
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J. DuPlessis
cDepartment of Clinical Neurosciences (J.D., S. Gatt), Royal Infirmary of Edinburgh, Edinburgh, UK
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M. Sonnberger
dDepartment of Neuroradiology (M.S., S. Gasser), Johannes Kepler University Linz, Linz, Austria
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C. Maurer
eDepartment of Diagnostic and Interventional Neuroradiology (C.M., A.B.), University Hospital Augsburg, Augsburg, Germany
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N. Kocer
fDepartment of Radiology (N.K.), Division of Neuroradiology, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Istanbul, Turkey
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M. Killer-Oberpfalzer
gDepartment of Neurology (M.K.-O.), Institute of Neurointervention, Paracelsus Medizinische Privatuniversität, Salzburg, Austria
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R. Rautio
hDepartment of Interventional Radiology (R.R.), Turku University Hospital, Turku, Finland
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L. Valvassori
iDepartment of Neuroradiology (L.V.), San Carlo Borromeo Hospital, Milano, Lombardia, Italy
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A. Berlis
eDepartment of Diagnostic and Interventional Neuroradiology (C.M., A.B.), University Hospital Augsburg, Augsburg, Germany
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S. Gasser
dDepartment of Neuroradiology (M.S., S. Gasser), Johannes Kepler University Linz, Linz, Austria
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S. Gatt
cDepartment of Clinical Neurosciences (J.D., S. Gatt), Royal Infirmary of Edinburgh, Edinburgh, UK
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A. Dörfler
bDepartment of Neuroradiology (H.L., A.D.), University of Erlangen-Nuremberg, Erlangen, Germany
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M. Bendszus
aFrom the Department of Neuroradiology (D.F.V., M.B., M.A.M.), Heidelberg University Hospital, Heidelberg, Germany
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M.A. Möhlenbruch
aFrom the Department of Neuroradiology (D.F.V., M.B., M.A.M.), Heidelberg University Hospital, Heidelberg, Germany
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  • FIG 1.
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    FIG 1.

    Treatment of an incidental aneurysm of the ICA with the FRED X. The preinterventional angiography including 3D reconstructions (A–C) showed a saccular sidewall aneurysm of the right ICA in an asymptomatic patient. A FRED X FD was placed in the parent artery, covering the aneurysm neck (D–F). On the angiography 13 months after the treatment (G–I), the aneurysm was completely occluded.

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    FIG 2.

    Treatment of an incidental PcomA aneurysm with the FRED X and coiling with intra- and postprocedural thrombosis. This patient, who had an incidental BA aneurysm treated with a Woven EndoBridge device (WEB; MicroVention) previously, presented with an incidental, irregularly shaped aneurysm of the ICA adjacent to the PcomA (A and B). After an uneventful treatment with FRED X implantation and coiling with a jailing technique (C), intraprocedural thrombus formation at the proximal part of the flow-diverting section of the stent was observed (white arrow in D). Tirofiban was instantly administered for 30 minutes, which led to a complete resolution of the thrombosis (E). Seven days after the treatment, after discontinuation of her ticagrelor medication, the patient presented with complete occlusion of the FD (F and G) with good collateralization via the contralateral side. Recanalization of the stent was achieved by tirofiban administration for 48 hours (H and I). The patient was neurologically asymptomatic the entire time.

Tables

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    Table 1:

    Patient and aneurysm characteristicsa

    Characteristics
    Patient age (mean) (range) (yr)55 (SD, 12) (27–79)
    Clinical presentationIncidentalRegrowth/persistent aneurysmbSAHHeadacheCo-incidentalcDiplopiaOther
    100 (62.1%)20 (12.4%)18 (11.2%)9 (5.6%)6 (3.7%)3 (1.9%)5 (3.1%)
    Aneurysm locationICABAMCAVAOther
    117 (72.7%)13 (8.1%)10 (6.2%)9 (5.6%)12 (7.5%)
    Aneurysm sized (mean) (range) (mm)7.8 (SD, 6.3) (1.0–46.0)
    Neck diameter (mean) (range) (mm)4.7 (SD, 3.8) (1.0–36.0)
    Dome-to-neck ratio (mean) (range)1.7 (SD, 0.9) (0.4–7.5)
    Diameter of the parent artery proximal and distal to the aneurysm mean) (range) (mm)ProximalDistal
    3.5 (SD, 0.8) (1.5–7.0)3.1 (SD, 0.7) (1.2–5.2)
    Aneurysm typeSaccularBlister-likeFusiformDissecting
    131 (81.4%)14 (8.7%)11 (6.8%)5 (3.1%)
    Sidewall or bifurcation aneurysmSidewallBifurcation
    136 (84.5%)25 (15.5%)
    • ↵a Data are as mean (minimum–maximum) or absolute number of cases (relative frequency in %).

    • ↵b Persistent aneurysm after previous treatment.

    • ↵c Aneurysm diagnosed because of a ruptured intracranial aneurysm elsewhere.

    • ↵d Maximal diameter.

    • View popup
    Table 2:

    Treatment parametersa

    Parameters
    Aneurysms treated in the respective treatment session1234
    144 (89.4%)13 (8.1%)2 (1.2%)2 (1.2%)
    Ease of deploymentbVery poorPoorIntermediateGoodVery good
    0 (0%)1 (0.6%)1 (0.6%)12 (7.5%)147 (91.3%)
    Vessel wall appositionbVery poorPoorIntermediateGoodVery good
    0 (0%)0 (0%)2 (1.2%)8 (5.0%)151 (93.8%)
    RadiopacitybVery poorPoorIntermediateGoodVery good
    0 (0%)0 (0%)0 (0%)59 (36.7%)102 (63.4%)
    Performance compared with FRED/FRED JrbWorseSlightly worseEquivalentSlightly betterBetter
    0 (0%)0 (0%)154 (96.3%)6 (3.8%)0 (0%)
    Additional coiling48 (29.8%)
    In-stent balloon angioplasty4 (2.5%)
    • ↵a Data are absolute number of cases (relative frequency in %).

    • ↵b Rated as an overall score for each treatment (not for each implanted FD).

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    Table 3:

    Adverse events and complicationsa

    Adverse events/complications
    Adverse eventTechnical periprocedural adverse eventMinor adverse eventMajor adverse eventNeurological morbidityMortality
    5 (3.1%)21 (13.0%)5 (3.1%)3 (1.9%)2 (1.2%)
    • ↵a Data are absolute number of cases (relative frequency in %).

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    Table 4:

    Occlusion ratesa

    Occlusion rates
    Occlusion at latest follow-upbI: Complete occlusionII: Residual neckIII: Residual aneurysm
    94 (66.2%)24 (16.9%)24 (16.9%)
    • ↵a Data are absolute number of cases (relative frequency in %).

    • ↵b Imaging follow-up was available for 142/161 patients with a mean follow-up period of 7.0 months, reported according to the RROC.

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D.F. Vollherbst, H. Lücking, J. DuPlessis, M. Sonnberger, C. Maurer, N. Kocer, M. Killer-Oberpfalzer, R. Rautio, L. Valvassori, A. Berlis, S. Gasser, S. Gatt, A. Dörfler, M. Bendszus, M.A. Möhlenbruch
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
American Journal of Neuroradiology Mar 2023, DOI: 10.3174/ajnr.A7834

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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
D.F. Vollherbst, H. Lücking, J. DuPlessis, M. Sonnberger, C. Maurer, N. Kocer, M. Killer-Oberpfalzer, R. Rautio, L. Valvassori, A. Berlis, S. Gasser, S. Gatt, A. Dörfler, M. Bendszus, M.A. Möhlenbruch
American Journal of Neuroradiology Mar 2023, DOI: 10.3174/ajnr.A7834
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