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Research ArticleInterventional

International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study

D.F. Kallmes, R. Hanel, D. Lopes, E. Boccardi, A. Bonafé, S. Cekirge, D. Fiorella, P. Jabbour, E. Levy, C. McDougall, A. Siddiqui, I. Szikora, H. Woo, F. Albuquerque, H. Bozorgchami, S.R. Dashti, J.E. Delgado Almandoz, M.E. Kelly, R. Turner, B.K. Woodward, W. Brinjikji, G. Lanzino and P. Lylyk
American Journal of Neuroradiology January 2015, 36 (1) 108-115; DOI: https://doi.org/10.3174/ajnr.A4111
D.F. Kallmes
aFrom the Department of Radiology (D.F.K., W.B., G.L.), Mayo Clinic, Rochester, Minnesota
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R. Hanel
bDepartment of Neurosurgery (R.H.), Mayo Clinic, Jacksonville, Florida
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D. Lopes
cDepartment of Neurological Surgery (D.L.), Rush University Medical Center, Chicago, Illinois
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E. Boccardi
dDepartment of Neuroradiology (E.B.), Niguarda CA' Granda Hospital, Milan, Italy
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A. Bonafé
eDepartment of Neuroradiology (A.B.), Hôpital Gui de Chauliac, Montpellier, France
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S. Cekirge
fDepartment of Radiology (S.C.), Hacettepe University Hospitals, Ankara, Turkey
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D. Fiorella
gDepartment of Neurological Surgery (D.F., H.W.), Stony Brook University Medical Center, Stony Brook, New York
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P. Jabbour
hDepartment of Neurosurgery (P.J.), Thomas Jefferson University, Philadelphia, Pennsylvania
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E. Levy
iDepartment of Neurosurgery (E.L., A.S.), University at Buffalo, State University of New York, Buffalo, New York
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C. McDougall
jDepartment of Neurosurgery (C.M., F.A.), Barrow Neurological Associates, Phoenix, Arizona
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A. Siddiqui
iDepartment of Neurosurgery (E.L., A.S.), University at Buffalo, State University of New York, Buffalo, New York
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I. Szikora
kNational Institute of Neurosciences (I.S.), Budapest, Hungary
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H. Woo
gDepartment of Neurological Surgery (D.F., H.W.), Stony Brook University Medical Center, Stony Brook, New York
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F. Albuquerque
jDepartment of Neurosurgery (C.M., F.A.), Barrow Neurological Associates, Phoenix, Arizona
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H. Bozorgchami
lDepartment of Neurology (H.B.), Oregon Health and Science University, Portland, Oregon
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S.R. Dashti
mNorton Neuroscience Institute (S.R.D.), Louisville, Kentucky
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J.E. Delgado Almandoz
nDepartment of Radiology (J.E.D.A.), Neuroscience Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota
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M.E. Kelly
oDivision of Neurosurgery, Department of Surgery (M.E.K.), University of Saskatchewan, Saskatoon, Saskatchewan, Canada
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R. Turner IV
pDepartment of Neurosciences (R.T.), Medical University of South Carolina, Charleston, South Carolina
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B.K. Woodward
qVista Radiology PC (B.K.W.), Knoxville, Tennessee
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W. Brinjikji
aFrom the Department of Radiology (D.F.K., W.B., G.L.), Mayo Clinic, Rochester, Minnesota
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G. Lanzino
aFrom the Department of Radiology (D.F.K., W.B., G.L.), Mayo Clinic, Rochester, Minnesota
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P. Lylyk
rDepartment of Neuroscience (P.L.), Equipo de Neurocirugía Endovascular Radiología Intervencionista, Buenos Aires, Argentina.
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Article Figures & Data

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    Table 1:

    Aneurysm characteristics

    Aneurysm CharacteristicsAnterior ICA ≥10 mm (n = 311)Anterior <10 mm (n = 349)Posterior (n = 59)Other Anterior ≥10 mm (n = 178)Total (n = 896)aP Value
    Aneurysm size (mm)
        Mean ± SD16.8 ± 6.25.2 ± 2.214.5 ± 9.09.8 ± 7.910.7 ± 7.7<.001
        Median, range15.0, 10.0–42.05.0, 1.0–9.911.8, 1.7–45.07.2, 1.0–55.09.0, 1.0–55.0
    Aneurysm type
        Small0349/349 (100%)19/58 (32.8%)105/178 (59.0%)473/897 (52.8%)
        Large268/311 (86.2%)029/58 (50.0%)60/178 (33.7%)357/897 (39.8%)
        Giant43/311 (13.8%)010/58 (17.2%)13/178 (7.3%)66/897 (7.3%)
    Aneurysm neck (mm)
        Mean ± SD8.5 ± 5.14.1 ± 2.29.3 ± 8.45.3 ± 5.16.2 + 4.9<.001
        Median, range7.6, 0.9–50.04.0, 0.8–22.08.0, 1.7–53.04.0, 1.0–50.05.0, 0.8–53.0
    Aneurysm shape
        Fusiform49/311 (15.8%)17/349 (4.9%)17/59 (28.8%)29/178 (16.3%)112/897 (12.5%)<.001
        Saccular239/311 (76.9%)305/349 (87.4%)25/59 (42.4%)118/178 (66.3%)686/897 (76.5%)
        Dissecting10/311 (3.2%)8/349 (2.3%)13/59 (22.0%)22/178 (12.4%)53/897 (5.9%)
        Other13/311 (4.2%)19/349 (5.4%)4/59 (6.8%)9/178 (5.1%)46/897 (5.1%)
    Aneurysm location
        Internal carotid artery311/311 (100%)349/349 (100%)00660/897 (73.6%)<.001
        Middle cerebral artery00043/178 (24.2%)43/897 (4.8%)
        Posterior cerebral artery0015/59 (25.4%)015/897 (1.7%)
        Basilar artery0044/59 (74.6%)044/897 (4.9%)
        Other000135/178 (75.8%)135/897 (15.1%)
    Presented with ruptured aneurysm12/311 (3.9%)24/345 (7.0%)4/59 (6.8%)34/176 (19.3%)74/891 (8.2%)<.001
    Multiple PEDs used143/311 (46.0%)97/347 (28.0%)19/59 (32.2%)47/178 (26.4%)306/895 (34.2%)<.001
    • Note:—n indicates the number of aneurysms.

    • ↵a Aneurysm size was not reported for 10 aneurysms.

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    Table 2:

    Complications by aneurysm location and size subgroups

    ComplicationsAnterior ICA ≥10 mm (n = 275)Anterior ICA <10 mm (n = 294)Posterior (n = 55)Other Anterior (n = 165)Total (n = 793)a95% CI; P Value
    Mean aneurysm size (mm)16.8 ± 6.25.2 ± 2.214.5 ± 9.09.8 ± 7.910.7 ± 7.7(10.2–11.2); <.001
    Spontaneous rupture4 (0.7%)0 (0.0%)0 (0.0%)1 (0.6%)5 (0.6%)(0.2%–1.5%); .17
    Intraparenchymal hemorrhage6 (2.2%)6 (2.0%)1 (1.8%)6 (3.6%)19 (2.4%)(1.3%–3.4%); .73
    Ischemic stroke15 (5.5%)8 (2.7%)4 (7.3%)10 (6.1%)37 (4.7%)(3.2%–6.2%); .16
    Parent artery stenosis1 (0.4%)1 (0.4%)0 (0.0%)0 (0.0%)2 (0.3%)(0%–0.7%); 1.0
    Cranial neuropathy2 (0.7%)0 (0.0%)0 (0.0%)0 (0.0%)2 (0.3%)(0%–0.7%); .30
    Neurologic morbidity24 (8.7%)14 (4.5%)5 (9.1%)16 (9.7%)59 (7.4%)(5.6%–9.2%); .16
    Neurologic mortality11 (4.0%)4 (1.4%)6 (10.9%)9 (5.5%)30 (3.8%)(2.5%–5.1%); <.01
    Neurologic morbidity and mortality (all patients)26 (9.5%)14 (4.8%)9 (16.4%)18 (10.9%)67 (8.4%)(6.5%–10.3%); .01
    Neurologic morbidity and mortality (patients with unruptured aneurysms)24/263 (9.2%)11/270 (4.1%)7/51 (13.7%)11/131 (8.4%)53/717 (7.4%)(5.5%–9.3%); .03
    Neurologic morbidity and mortality (patients with ruptured aneurysms)2/12 (16.7%)3/24 (12.5%)2/4 (50.0%)7/34 (20.6%)14/76 (18.4%)(10.0%–27.1%); .35
    Neurologic morbidity and mortality (excluding ruptured, dissecting, or fusiform aneurysms)15 (7.0%)9 (3.6%)3 (12.0%)6 (6.8%)33 (5.7%)(4.1%–7.3%); .19
    • Note:—n indicates the number of patients.

    • ↵a Numbers do not sum across categories and subcategories because some patients experienced >1 event.

    • View popup
    Table 3:

    Occurrence of complications by time

    Complications<72 Hours72 Hours–30 Days>30 DaysTotal (n = 793)aP Value
    Anterior (n = 738)Posterior (n = 55)Anterior (n = 738)Posterior (n = 55)Anterior (n = 738)Posterior (n = 55)
    Spontaneous rupture1 (0.1%)0 (0%)3 (0.4%)0 (0%)1 (0.1%)0 (0%)5 (0.6%).51
    Intraparenchymal hemorrhage3 (0.4%)1 (1.8%)11 (1.5%)0 (0%)4 (0.5%)0 (0%)19 (2.4%).83
    Ischemic stroke17 (2.3%)2 (3.6%)7 (0.9%)0 (0%)9 (1.2%)2 (3.6%)37 (4.7%).58
    Parent artery stenosis0 (0%)0 (0%)1 (0.1%)0 (0%)1 (0.1%)0 (0%)2 (0.3%).63
    Cranial neuropathy0 (0%)0 (0%)2 (0.3%)0 (0%)0 (0%)0 (0%)2 (0.3%).58
    Neurologic morbidity20 (2.7%)3 (5.5%)21 (2.8%)0 (0%)13 (1.8%)2 (3.6%)59 (7.4%).56
    Neurologic mortality4 (0.5%)1 (1.8%)13 (1.8%)2 (3.6%)7 (0.9%)3 (5.5%)30 (3.8%)<.01
    Neurologic morbidity and mortality (all patients)23 (3.1%)3 (5.5%)22 (3.0%)2 (3.6%)13 (1.8%)4 (7.3%)67 (8.4%)<.01
    Neurologic morbidity and mortality (patients with unruptured aneurysms)19/664 (2.9%)3/51 (5.9%)16/664 (2.4%)1/51 (2.0%)11/664 (1.7%)3/51 (5.9%)53/717 (7.4%).08
    Neurologic morbidity and mortality (patients with ruptured aneurysms)4/70 (5.7%)0/4 (0%)6/70 (8.6%)1/4 (25.0%)2/70 (2.9%)1/4 (25.0%)14/76 (18.4%).17
    Neurologic morbidity and mortality (excluding ruptured, dissecting, or fusiform aneurysms)13/549 (2.4%)1/25 (4.0%)12/549 (2.2%)0/25 (0%)5/549 (0.9%)2/25 (8.0%)33/575 (5.7%).41
    • Note:—n indicates the number of patients.

    • ↵a Numbers do not sum across categories and subcategories because some patients experienced >1 event.

    • View popup
    Table 4:

    Complications by aneurysm size

    ComplicationsSmall (n = 386) (N = 473)Large (n = 339) (N = 357)Giant (n = 62) (N = 66)Total (n = 793)a,b (N = 906)P Value
    Anterior (n = 372)Posterior (n = 14)Anterior (n = 309)Posterior (n = 30)Anterior (n = 52)Posterior (n = 10)
    Mean aneurysm size (mm)5.1 ± 2.26.0 ± 2.614.8 ± 4.015.0 ± 4.328.8 ± 5.329.1 ± 7.210.7 ± 7.7<.001
    Spontaneous rupture0 (0%)0 (0%)2 (0.5%)0 (0%)3 (5.8%)0 (0%)5 (0.6%)<.01
    Intraparenchymal hemorrhage7 (1.9%)0 (0%)8 (2.6%)0 (0%)3 (5.8%)1 (10.0%)19 (2.4%).24
    Ischemic stroke10 (2.7%)1 (7.1%)16 (5.2%)1 (3.3%)7 (13.5%)2 (20.0%)37 (4.7%)<.01
    Parent artery stenosis1 (0.3%)0 (0%)1 (0.3%)0 (0%)0 (0%)0 (0%)2 (0.3%)1.0
    Cranial neuropathy0 (0%)0 (0%)2 (0.6%)0 (0%)0 (0%)0 (0%)2 (0.3%).41
    Neurologic morbidity18 (4.8%)1 (7.1%)24 (7.8%)1 (3.3%)12 (23.1%)3 (30.0%)59 (7.4%)<.01
    Neurologic mortality6 (1.6%)1 (7.1%)15 (4.9%)2 (6.7%)3 (5.8%)3 (30.0%)30 (3.8%)<.01
    Neurologic morbidity and mortalitya (all patients)19 (5.1%)2 (14.3%)27 (8.7%)3 (10.0%)12 (23.1%)4 (40.0%)67 (8.4%)<.01
    Neurologic morbidity and mortality (patients with unruptured aneurysms)11/321 (3.4%)1/12 (8.3%)23/291 (7.9%)3/29 (10.3%)12/51 (23.5%)3/9 (33.3%)53/717 (7.4%)<.01
    Neurologic morbidity and mortality (patients with ruptured aneurysms)8/51 (15.7%)1/2 (50.0%)4/18 (22.2%)0/1 (0%)0/1 (0%)1/1 (100%)14/76 (18.4%).23
    Neurologic morbidity and mortality (excluding ruptured, dissecting, or fusiform aneurysms)11/294 (3.7%)0/7 (0%)12/217 (5.5%)2/13 (15.4%)7/37 (18.9%)1/5 (20.0%)33/574 (5.7%)<.01
    • Note:—n indicates the number of patients; N, number of aneurysms.

    • ↵a Six patients did not have aneurysm size reported.

    • ↵b Numbers do not sum across categories because some patients experienced >1 event.

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American Journal of Neuroradiology: 36 (1)
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International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study
D.F. Kallmes, R. Hanel, D. Lopes, E. Boccardi, A. Bonafé, S. Cekirge, D. Fiorella, P. Jabbour, E. Levy, C. McDougall, A. Siddiqui, I. Szikora, H. Woo, F. Albuquerque, H. Bozorgchami, S.R. Dashti, J.E. Delgado Almandoz, M.E. Kelly, R. Turner, B.K. Woodward, W. Brinjikji, G. Lanzino, P. Lylyk
American Journal of Neuroradiology Jan 2015, 36 (1) 108-115; DOI: 10.3174/ajnr.A4111

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International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study
D.F. Kallmes, R. Hanel, D. Lopes, E. Boccardi, A. Bonafé, S. Cekirge, D. Fiorella, P. Jabbour, E. Levy, C. McDougall, A. Siddiqui, I. Szikora, H. Woo, F. Albuquerque, H. Bozorgchami, S.R. Dashti, J.E. Delgado Almandoz, M.E. Kelly, R. Turner, B.K. Woodward, W. Brinjikji, G. Lanzino, P. Lylyk
American Journal of Neuroradiology Jan 2015, 36 (1) 108-115; DOI: 10.3174/ajnr.A4111
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