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AJNR Awards, New Junior Editors, and more. Read the latest AJNR updates

Research ArticleNeurointervention

Initial Experience with p64: A Novel Mechanically Detachable Flow Diverter for the Treatment of Intracranial Saccular Sidewall Aneurysms

S. Fischer, M. Aguilar-Pérez, E. Henkes, W. Kurre, O. Ganslandt, H. Bäzner and H. Henkes
American Journal of Neuroradiology November 2015, 36 (11) 2082-2089; DOI: https://doi.org/10.3174/ajnr.A4420
S. Fischer
aFrom the Neuroradiologische Klinik (S.F., M.A.-P., E.H., W.K., H.H.)
dthe Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin (S.F.), Universitätsklinikum Knappschaftskrankenhaus, Bochum, Germany.
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M. Aguilar-Pérez
aFrom the Neuroradiologische Klinik (S.F., M.A.-P., E.H., W.K., H.H.)
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E. Henkes
aFrom the Neuroradiologische Klinik (S.F., M.A.-P., E.H., W.K., H.H.)
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W. Kurre
aFrom the Neuroradiologische Klinik (S.F., M.A.-P., E.H., W.K., H.H.)
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O. Ganslandt
bNeurochirurgische Klinik (O.G.)
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H. Bäzner
cNeurologische Klinik (H.B.), Neurozentrum, Klinikum Stuttgart, Stuttgart, Germany
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H. Henkes
aFrom the Neuroradiologische Klinik (S.F., M.A.-P., E.H., W.K., H.H.)
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    Fig 1.

    Detachment mechanism of the p64. Eight bundles, each containing 8 wires, are attached to a slotted crown (A) and released from there by pulling a polymer hypotube in the proximal direction (B). Image courtesy of phenox.

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    Fig 2.

    Manual detachment of the p64. The p64 comes with a torque device, which is locked over the hypotube to hold this hypotube in position (A). The detachment starts with unlocking the torquer, repositioning it, and again locking it approximately 15 mm proximally (B). A handle on the hypotube is then moved proximally (C).

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    Fig 3.

    De novo unruptured paraclinoid aneurysm (7 × 5 mm) in a 63-year-old woman with a history of 2 spontaneous SAHs from 2 MCA bifurcation aneurysms, which had been clipped. The paraclinoid aneurysm was not considered ideal for coil occlusion alone (A), and the patient was reluctant to undergo surgery again. A single Morpheus 7 × 21 cm 3D coil (Medtronic, Dublin, Ireland) was inserted into the aneurysm. The aneurysm neck was then covered by a 4 × 18 mm p64 (B). DSA follow-up 93 days later reveals complete occlusion of the aneurysm (C).

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    Fig 4.

    A small saccular aneurysm of the basilar trunk (4 × 3 mm) (A) in a 56-year-old woman. Both surgery and coil occlusion were not considered suitable treatment options. A 4.5 × 15 mm p64 was deployed in the basilar artery with complete coverage of the aneurysm (B). Although the procedure was well-tolerated, the patient developed a hemiparesis and dysarthria (mRS 3) 26 days later. MR imaging shows an ischemic pontine lesion (C); a Multiplate test (not shown) confirmed insufficient platelet function inhibition. Antiaggregation was switched to ticagrelor, and the patient subsequently recovered (mRS 1). Follow-up DSA after 28 days (D) and after 421 days (E) shows complete occlusion of the aneurysm.

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    Table 1:

    Inclusion and exclusion criteria for the presented series of patients treated with p64

    Criteria for the p64 Treatment and Analysis in this Series
    Inclusion
        Intracranial saccular sidewall aneurysm as treatment target
        Aneurysms unruptured or at least not in the acute phase after rupture
        Extra- or intradural symptomatic aneurysm
        Asymptomatic intradural aneurysms, thus carrying a potential risk of intracranial rupture
        Anticipated difficulty of coil or clip treatment (eg, complex aneurysm morphology, wide neck, dome-to-neck ratio of <1.2, small size, difficult surgical access)
        No previous treatment or any previous treatment directed at the aneurysm sac without complete occlusion of the aneurysm from circulation
         No previous treatment to the parent vessel
        An ability and willingness of the patient to take the necessary medication for midterm dual platelet function inhibition
    Exclusion
        Bifurcation-type aneurysm or fusiform vessel dilation as a treatment target
        Implants other than p64 used
        Aneurysm rupture ≤30 days prior to the p64 treatment
        Extradural asymptomatic aneurysm
        Anticipated ease or sufficiency of clip or coil treatment
        Previous implantation of stents or flow diverters to the target-vessel segment
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    Table 2:

    Breakdown of aneurysm occlusion rate and complication incidence according to the size of the aneurysm fundus

    Fundus Diameter
    1–3 mm (n = 59)4–6 mm (n = 42)7–9 mm (n = 15)>10 mm (n = 14)
    Early follow-up55/59 (93%)42/42 (100%)15/15 (100%)12/14 (85.7%)
        Complete occlusion31 (56.4%)28 (66.7%)9 (60%)4 (33.3%)
        Neck remnant13 (23.6%)4 (9.5%)2 (13%)7 (58.3%)
        Sac remnant7 (12.7%)5 (11.9%)3 (20%)1 (8.3%)
        Unchanged4 (7.3%)4 (9.5%)1 (6.7%)0
    Midterm follow-up46/59 (78%)34/42 (81%)11/15 (73.3%)8/14 (57.1%)
        Complete occlusion37 (80.4%)26 (76.5%)9 (81.8%)4 (50%)
        Neck remnant3 (6.5)5 (14.7%)2 (18.2%)3 (37.5%)
        Sac remnant4 (8.7%)2 (5.9%)01 (12.5%)
        Unchanged2 (4.3%)1 (2.9%)00
    Complications1 Pontine ischemia1 Pontine ischemia1 TIA1 Death
    1 CN VI palsy1 TIA1 Asymptomatic thrombosis1 Pulmonary artery occlusion
    1 Asymptomatic thrombosis
    • Note:—CN indicates cranial nerve.

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American Journal of Neuroradiology: 36 (11)
American Journal of Neuroradiology
Vol. 36, Issue 11
1 Nov 2015
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Cite this article
S. Fischer, M. Aguilar-Pérez, E. Henkes, W. Kurre, O. Ganslandt, H. Bäzner, H. Henkes
Initial Experience with p64: A Novel Mechanically Detachable Flow Diverter for the Treatment of Intracranial Saccular Sidewall Aneurysms
American Journal of Neuroradiology Nov 2015, 36 (11) 2082-2089; DOI: 10.3174/ajnr.A4420

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Initial Experience with p64: A Novel Mechanically Detachable Flow Diverter for the Treatment of Intracranial Saccular Sidewall Aneurysms
S. Fischer, M. Aguilar-Pérez, E. Henkes, W. Kurre, O. Ganslandt, H. Bäzner, H. Henkes
American Journal of Neuroradiology Nov 2015, 36 (11) 2082-2089; DOI: 10.3174/ajnr.A4420
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