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Research ArticleNeurointervention

A Second-Generation, Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms

D.F. Kallmes, Y.H. Ding, D. Dai, R. Kadirvel, D.A. Lewis and H.J. Cloft
American Journal of Neuroradiology June 2009, 30 (6) 1153-1158; DOI: https://doi.org/10.3174/ajnr.A1530
D.F. Kallmes
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Y.H. Ding
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D. Dai
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R. Kadirvel
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D.A. Lewis
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H.J. Cloft
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  • Fig 1.
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    Fig 1.

    A, DSA immediately after implantation shows that the aneurysm remains completely open to the parent artery. B, This DSA image at 1 month shows that the aneurysm is completely occluded. The distal portion of the parent artery is somewhat narrowed compared with the postimplantation image (A). The right vertebral artery remains patent.

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    Fig 2.

    A, This DSA immediately after implantation and (B) 1 month after implantation show near-complete occlusion of the aneurysm cavity at follow-up. The parent artery and the ipsilateral vertebral artery remain patent.

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    Fig 3.

    A, Photomicrograph (H&E; magnification, ×20) of the vertebral artery. B, Photomicrograph (H&E; magnification, ×25) of a lumbar artery. Both the vertebral and lumbar arteries had a device placed across their ostia. The vessels remained patent. The neointima across the origin of each vessel is discontinuous.

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    Fig 4.

    A, SEM photograph (magnification, ×20) of the vertebral artery. B, An SEM of the ostium of the lumbar artery (magnification, ×20). Both the vertebral and lumbar arteries had a device placed across their ostia. The vessels remained patent. The tissue covering the stents at the origins of branch vessels is continuous with that covering or on the devices at the aorta and parent artery.

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    Table 1:

    Aneurysm description by duration in PED studies 1 and 2*

    Time (month/s)PED-1 Neck (mm)PED-2 Neck (mm)PED-1 Width (mm)PED-2 Width (mm)PED-1 Height (mm)PED-2 Height (mm)PED-1 Aspect RatioPED-2 Aspect Ratio
    12.9 ± 1.53.4 ± 1.23.6 ± 0.84.8 ± 0.98.0 ± 2.39.8 ± 1.93.1 ± 1.03.0 ± 0.7
    32.7 ± 1.23.4 ± 1.03.8 ± 0.74.3 ± 0.87.7 ± 2.110.1 ± 2.43.2 ± 1.53.1 ± 0.4
    63.2 ± 0.73.2 ± 0.93.8 ± 0.94.5 ± 0.98.0 ± 2.111.6 ± 2.32.6 ± 0.83.7 ± 0.5
    • Note:—PED indicates Pipeline Embolization Device.

    • * Data are represented as the mean ± SD. There were no significant differences.

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    Table 2:

    Morphometric measurements in aortic segments

    Time (month/s)PED-1 Injury ScorePED-2 Injury ScorePED-1 Neointimal Thickness (mm)PED-2 Neointimal Thickness (mm)PED-1 Area Stenosis (%)PED-2 Area Stenosis (%)PED-1 Diameter Stenosis (%)PED-2 Diameter Stenosis (%)
    10.0 ± 0.0*0.0 ± 0.00.2 ± 0.10.1 ± 0.020 ± 510 ± 510 ± 37 ± 2
    30.3 ± 0.20.0 ± 0.0*0.2 ± 0.10.1 ± 0.016 ± 59 ± 313 ± 116 ± 1
    60.1 ± 0.20.1 ± 0.00.1 ± 0.00.1 ± 0.015 ± 68 ± 29 ± 35 ± 2
    • Note:—Data are represented as the mean ± SD. There was a significant (P = .0128) mean injury score interaction.

    • * Indicates a significant difference between the * value and the PED-1 at 3 months’ value (Tukey post hoc test).

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    Table 3:

    Morphometric measurements in aneurysm-bearing arterial segments

    1 Month3 Months6 Months
    ProximalDistalProximalDistalProximalDistal
    Injury scorePED-10.0 ± 0.0 (n = 2)0.1 ± 0.2 (n = 6)0.1 ± 0.1 (n = 3)0.1 ± 0.2 (n = 4)0.0 ± 0.0 (n = 4)0.1 ± 0.1 (n = 6)
    PED-20.0 ± 0.0 (n = 4)0.0 ± 0.0 (n = 6)0.0 ± 0.0 (n = 6)0.0 ± 0.0 (n = 6)0.0 ± 0.0 (n = 3)0.0 ± 0.0 (n = 5)
    Neointimal thickness (mm)PED-10.2 ± 0.1 (n = 2)0.2 ± 0.0 (n = 6)0.2 ± 0.0 (n = 3)0.1 ± 0.0* (n = 4)0.2 ± 0.1 (n = 4)0.1 ± 0.0* (n = 6)
    PED-20.2 ± 0.0 (n = 4)0.1 ± 0.0* (n = 6)0.1 ± 0.0 (n = 6)0.1 ± 0.0 (n = 6)0.1 ± 0.0 (n = 3)0.1 ± 0.0 (n = 5)
    Maximal area stenosis (%)PED-122 ± 2 (n = 5)38 ± 13 (n = 6)35 ± 18 (n = 2)30 ± 10 (n = 4)23 ± 8 (n = 4)17 ± 8 (n = 6)
    PED-212 ± 1 (n = 3)22 ± 10 (n = 6)15 ± 3 (n = 6)18 ± 7 (n = 6)16 ± 7 (n = 3)19 ± 5 (n = 5)
    Maximal diameter stenosis (%)PED-111 ± 5 (n = 2)20 ± 10 (n = 6)17 ± 7 (n = 3)12 ± 3 (n = 4)12 ± 6 (n = 4)11 ± 7 (n = 6)
    PED-29 ± 0.0 (n = 1)14 ± 6 (n = 6)9 ± 2 (n = 6)10 ± 3 (n = 6)5 ± 2 (n = 5)9 ± 4 (n = 3)
    • Note:—Proximal indicates the proximal end of the stented parent artery; distal, the distal end of the stented parent artery. Data are represented as the mean ± SD.

    • * Indicates a significant difference in neointimal thickness between the distal 1-month PED-1 and other distal locations (P < .05).

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American Journal of Neuroradiology: 30 (6)
American Journal of Neuroradiology
Vol. 30, Issue 6
June 2009
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D.F. Kallmes, Y.H. Ding, D. Dai, R. Kadirvel, D.A. Lewis, H.J. Cloft
A Second-Generation, Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms
American Journal of Neuroradiology Jun 2009, 30 (6) 1153-1158; DOI: 10.3174/ajnr.A1530

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A Second-Generation, Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms
D.F. Kallmes, Y.H. Ding, D. Dai, R. Kadirvel, D.A. Lewis, H.J. Cloft
American Journal of Neuroradiology Jun 2009, 30 (6) 1153-1158; DOI: 10.3174/ajnr.A1530
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