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Research ArticleINTERVENTIONAL

Cerebral Aneurysm Multicenter European Onyx (CAMEO) Trial: Results of a Prospective Observational Study in 20 European Centers

Andrew J. Molyneux, Saruhan Cekirge, Isil Saatci and Gyula Gál
American Journal of Neuroradiology January 2004, 25 (1) 39-51;
Andrew J. Molyneux
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Saruhan Cekirge
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Isil Saatci
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Gyula Gál
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Article Figures & Data

Figures

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  • Fig 1.
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    Fig 1.

    60-year-old male patient who presented with headache and in whom a large unruptured internal carotid aneurysm was found. Pretreatment, treatment, and follow-up images are presented.

    A, Large internal carotid aneurysm before treatment.

    B, Seal test before treatment of the aneurysm with Onyx. Microcatheter and balloon are in place with gentle contrast material injection into the aneurysm

    C, Angiographic result immediately after Onyx treatment.

    D, Follow-up angiogram 6 months after treatment, showing complete occlusion and intervening soft thickened tissue between vessel lumen and Onyx cast in the aneurysm

  • Fig 2.
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    Fig 2.

    28-year-old hemophiliac patient with severe headaches but no evidence of subarachnoid hemorrhage has a wide-neck basilar bifurcation aneurysm involving the proximal right postcerebral artery.

    A, Large basilar bifurcation and proximal posterior cerebral aneurysms.

    B, Seal test, showing highly compliant Equinox balloon inflated in the basilar tip and in the right posterior cerebral artery with the balloon protecting the aneurysm neck, which takes up most of the proximal P1-segment vessel.

    C, Immediate posttreatment image, showing reconstruction of the posterior cerebral artery segment.

    D, Three-month follow-up angiogram, showing occlusion of the proximal posterior cerebral artery and the aneurysm.

    E, Three-month right carotid angiogram, showing posterior cerebral perfusion via the posterior communicating artery. (Images courtesy of Mike Nelson, Leeds.)

  • Fig 3.
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    Fig 3.

    50-year-old male patient with leg weakness and a possible history of subarachnoid hemorrhage. This patient was found to have a vertebral basilar junction aneurysm compressing the medulla.

    A, Pretreatment angiogram showing a large vertebrobasilar junction aneurysm treated on two occasions (treated with an INX stent at the second procedure after recurrence). Complete occlusion was noted at 6-month and 1-year follow-up after second procedure.

    B, Angiogram obtained after second treatment at 3 months after early recurrence and after placement of an INX stent and re-treatment with Onyx.

    C, Unsubtracted image obtained after second procedure, showing INX stent and second cast of Onyx in inferior recurrent aneurysm pocket.

    D, Follow-up angiogram obtained 6 months after second treatment.

  • Fig 4.
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    Fig 4.

    45-year-old patient presenting with a partial cranial nerve III palsy and headache. No anterior cerebral artery was present on the left side and the carotid only supplied the left middle cerebral territory.

    A, Lateral arterial phase carotid angiogram obtained immediately before treatment.

    B, Final angiography obtained after Onyx treatment balloon catheter still present in vessel.

    C, Follow-up angiography 3 months after procedure. Patient developed a complete ophthalomoplegia immediately after the procedure, which had resolved entirely by 3 months when she was asymptomatic. Note extensive orbital collaterals filling middle cerebral territory. (Images courtesy of Peter Flynn and Steven Mckinstry, Royal Victoria Hospital, Belfast.)

Tables

  • Figures
    • View popup
    TABLE 1:

    Patient demographics and aneurysm locations

    Sex79% Female
    Age (y)Median = 46 y, Mean = 45 y
    (Range: 6–76 y)
    Presentation
     SAH:
     Recent (<1 mo)10
     Late (>1 mo)7
     Incidental29
     Mass Effect (including CN palsies)39
     Headache alone7
     Seizures2
     Other:6
     Nasal Bleeding3
     F/U of traumatic CCF2
     Previous SAH 1 y ago1
    Previously Treated
     Coil15
     Clip0
     Wrap2
     Stent3
    • Note.—SAH indicates subarachnoid hemorrhage; CN, cranial nerve; F/U, follow-up; and CCF, carotid cavernous fistula.

    • View popup
    TABLE 2:

    Size and location of aneurysms

    Location
     Carotid n = 93
      Petrous6
      Cavernous25
      Petrous/Cavernous2
      Ophthalmic47
      Other intracranial sites13
     Posterior circulation n = 7
      Vertebral1
      Vertebrobasilar1
      Superior cerebellar1
      Posterior cerebral2
      Basilar tip2
    Average aneurysm size (mm)*
    MedianRange
    Dome height154–40
    Dome width143–44
    Neck width71–25
    TotalNeck <4 mmNeck ≥4 mmNeck ≥4 mm or D:N <2
    Aneurysm sac (mm)
     Small (<10 mm)2161518
     Large (10–25 mm)6035757
     Giant (>25 mm)1901919
    n = 100†10099194
    • * 1 aneurysm nearly fusiform mc

    • † Includes 1 fusiform neck.

    • View popup
    TABLE 3:

    Angiographic outcomes assessed by core lab: immediate, 3 months, and 1 year

    Small <10 mmLarge 10–24 mmGiant >25 mm
    Postembolization occlusion rates
    n = 20 (%)n = 60 (%)n = 19 (%)
     Complete (100%)15 (75)33 (55)19 (47)
     Subtotal (90–99%)5 (25)26 (43)19 (47)
     Incomplete (<90%)—1 (2)1 (5)
    3–6 month follow-up occlusion rates
    n = 15 (%)n = 51 (%)n = 15 (%)
     Complete (100%)13 (86.7)31 (61)8 (53)
     Subtotal (90–99%)1 (6.7)12 (23)4 (27)
     Incomplete (<90%)1 (6.7)7 (14)2 (13)
     Not determinable1 (2)1 (7)
    12-month follow-up occlusion rates
    After re-treatment, when applicable
    n = 14 (%)n = 39 (%)n = 14 (%)
     Complete (100%)13 (93)30 (77)8 (57)
     Subtotal (90–99%)05 (13)2 (14)
     Incomplete (<90%)1 (7)2 (5)2 (14)
     Not determinable2 (5)2 (14)
    • View popup
    TABLE 4:

    Procedural data

    Number of Procedures108
    Procedure time
    (Start time = time at which delivery catheter is filled with DSMO; Stop time = delivery catheter detachment from Oynx mass)
     Mean95 min
     Range15 min–360 min
    First 54 procedures
     Mean101 min
     Range15–300 min
    Second 54 procedures
     Mean90 min
     Range20–360 min
    Onyx volume
     Mean1.875 cc
     Range0.07–10.25 cc
    Treatment with Onyx + Stent
     Initial treatment17
     Re-treatment5
    • View popup
    TABLE 5:

    Baseline clinical and clinical outcome at 3 and 12 months

    Unruptured and OtherRecent SAH
    At baselinen = 87n = 10
    Baseline Rankin ≥281—
    Hunt & Hess grade
     1 or 2—7
     43
    At discharge* with including re-treatment as applicablen = 86†n = 10
    Rankin ≤276 (88%)5
    (95% CI 79–94)
     Rankin Unchanged/improved75—
     Rankin Worsened8 (9%)—
     Death at discharge31
    At 3–6 months including re-treatment as applicablen = 82n = 7
     Rankin ≤274 (90%)6
    (95% CI 82–96)
     Rankin Unchanged/improved747
     Rankin Worsened50
     Death at discharge to 3 months00
    1 lost to f/u
    1 no data at 3 mths
    At 12-Months or latest f/u, with re-treatment as applicablen = 83†n = 7
     Rankin ≤276 (91.5%)4
    (95% CI 83–96)
     Rankin Unchanged/improved756
     Rankin Worsened30
     Death at 3 months to 12 months21
    • * Discharge data missing in 1.

    • † Includes four patients with no 3–6 month follow-up Rankin score.

    • View popup
    TABLE 6:

    Serious adverse events with neurologic morbidity

    Patient Age (y)/SexSize and Location of AneurysmDescription of Event and Cause of EventCauseBaseline Rankin or H& HOutcome of Event and mRS at Last Follow-Up
    Permanent morbidity
     39/MLarge carotid ophthalmicIpsilateral visual loss due to leak in ophthalmic arteryDevice0mRS = 1
     42/FGiant carotid cavernousWorsened CN III, IV, V, and VI palsy, resolution of CN v aplsyProcedure1mRS = 1
     76/FSmall posterior communicatingWorsening of neurologic status (Grade, 2 H&H)SAH2Lost to follow-up
     75/FGiant carotid cavernousMild hemiparesisDevice (Onyx)1mRS = 1
     44/MSmall carotid ophthalmicNumbness in L leg caused by senosis of M3 MCADevice (Onyx)0mRS = 1
     56/MGiant carotid ophthalmicOnyx extravasation into subarachnoid space, SAH, severe hemiplegiaDevice (Onyx)1Ongoing at 12 mnths, mRS = 4
     45/FLarge carotid ophthalmicBlindness in R eye post procedure with retinal infarctDevice (Onyx)0mRS = 1
     55/FLarge carotid ophthalmicDevloped delayed L MCA infarct 3 days afer retreatment with stent and Onyx caused aphasia and R hemiplegiaDevice (Stent)2Ongoing at 3 months, mRS = 4 Partial resolution by 1 year
    Transient neurologic morbidity
     52/MLarge carotid ophthalmicDeveloped symptomatic vasospasm with L hemiparesis; recent SAHDiseaseGrade 2 H&HmRS = 0 Resolved
     47/FLarge superiorDeveloped transient hemiparesisDevice (also had stent placement)0mRS = 0 Resolved
     50/MLarge vertebro-basilar junctionDeveloped small SAH after catheter withdrawal; no neurologic deterioration; developed infected hematoma after 10 days retreatment procedure; required surgeryProcedure
     37/FSmall carotid cavernousDeveloped confusion and ipsilateral hemiparesis headaches and nausea 1 week after treatmentUnknown1mRS = 1 Resolved by 6 months
     57/FLarge carotid cavernousProcedural thrombus in left ICA; hemiparesis and aphasia; resolution of morbidityProcedure0mRS = 1 Resolved by 2 days
     31/FLarge carotid ophthalmicTransient hemiparesisProcedure0mRS = 0 Resolved
     45/FLarge carotid ophthalmicDeveloped worsened visual symptoms that subsequently improgedDevice0mRS = 1 Complete resolution and visual improvement
     68/FRecurrent basilar tipDeveloped proximal brain stem stroke post procedure, probably thrombo-embolic, needed prolonged hospitalisationProcedure1mRS = 2 Neurological symptoms fully resolved by 1 year
    • View popup
    TABLE 7:

    Results of treatment on mass effect

    Optic nerve compression
    BaselineAt Discharge12-Month or Latest Follow-up
     No. of patients14
     Improved/resolved26
     Unchanged117
     Worsened11
     Additional patients10*
    *1 no follow up to date
    Occulo-motor deficits
    BaselineAt Discharge12-Month or Latest Follow-up
     No. of patients16
     Improved/resolved614
     Unchanged81
     Worsened11
    1 = died prior discharge
    Hemiparesis or hemiplegia
    BaselineAt Discharge12-Month or Latest Follow-up
     No. of patients8
     Improved/resolved15
     Unchanged51
     Worsened00
    2* = died
    Headache (all), n = 57 at baseline
    BaselineAt Discharge12-Month or Latest Follow-up
    Mild/moderate
     No. of patients48
     Improved/resolved4342
     Unchanged21
     Worsened02
    3 = died
    At Discharge12-Month or Latest Follow-up
    Severe
     No. of patients9
     Improved/resolved88
     Unchanged10
     Worsened00
    1 = lost to follow up
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American Journal of Neuroradiology: 25 (1)
American Journal of Neuroradiology
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1 Jan 2004
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Andrew J. Molyneux, Saruhan Cekirge, Isil Saatci, Gyula Gál
Cerebral Aneurysm Multicenter European Onyx (CAMEO) Trial: Results of a Prospective Observational Study in 20 European Centers
American Journal of Neuroradiology Jan 2004, 25 (1) 39-51;

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Cerebral Aneurysm Multicenter European Onyx (CAMEO) Trial: Results of a Prospective Observational Study in 20 European Centers
Andrew J. Molyneux, Saruhan Cekirge, Isil Saatci, Gyula Gál
American Journal of Neuroradiology Jan 2004, 25 (1) 39-51;
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