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Research ArticleNeurointervention

Early Postmarket Results with EmboTrap II Stent Retriever for Mechanical Thrombectomy: A Multicenter Experience

A. Srivatsan, V.M. Srinivasan, R.M. Starke, E.C. Peterson, D.R. Yavagal, A.E. Hassan, A. Alawieh, A.M. Spiotta, Y. Saleem, K.M. Fargen, S.Q. Wolfe, R.A. de Leacy, I.P. Singh, I.L. Maier, J.N. Johnson, J.-K. Burkhardt, S.R. Chen and P. Kan
American Journal of Neuroradiology May 2021, 42 (5) 904-909; DOI: https://doi.org/10.3174/ajnr.A7067
A. Srivatsan
aFrom the Department of Neurosurgery and Neurology (A.S., V.M.S., Y.S., J.N.J., J.-K.B., P.K.), Baylor College of Medicine, Houston, Texas
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V.M. Srinivasan
aFrom the Department of Neurosurgery and Neurology (A.S., V.M.S., Y.S., J.N.J., J.-K.B., P.K.), Baylor College of Medicine, Houston, Texas
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R.M. Starke
bDepartment of Neurosurgery (R.M.S., E.C.P., D.R.Y.), University of Miami Miller School of Medicine, Miami, Florida
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E.C. Peterson
bDepartment of Neurosurgery (R.M.S., E.C.P., D.R.Y.), University of Miami Miller School of Medicine, Miami, Florida
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D.R. Yavagal
bDepartment of Neurosurgery (R.M.S., E.C.P., D.R.Y.), University of Miami Miller School of Medicine, Miami, Florida
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A.E. Hassan
cDepartment of Neurology and Radiology (A.E.H.), University of Texas Health Science Center San Antonio, San Antonio, Texas
dDepartment of Neurology (A.E.H.), University of Texas Rio Grande Valley, Harlingen, Texas
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A. Alawieh
eDepartment of Neurosurgery (A.A., A.M.S.), Medical University of South Carolina, Charleston, South Carolina
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A.M. Spiotta
eDepartment of Neurosurgery (A.A., A.M.S.), Medical University of South Carolina, Charleston, South Carolina
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Y. Saleem
aFrom the Department of Neurosurgery and Neurology (A.S., V.M.S., Y.S., J.N.J., J.-K.B., P.K.), Baylor College of Medicine, Houston, Texas
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K.M. Fargen
fDepartment of Neurosurgery (K.M.F., S.Q.W.), Wake Forest University School of Medicine, Winston-Salem, North Carolina
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S.Q. Wolfe
fDepartment of Neurosurgery (K.M.F., S.Q.W.), Wake Forest University School of Medicine, Winston-Salem, North Carolina
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R.A. de Leacy
gDepartment of Neurosurgery (R.A.d.L., I.P.S.), Mt. Sinai Icahn School of Medicine, New York, New York
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I.P. Singh
gDepartment of Neurosurgery (R.A.d.L., I.P.S.), Mt. Sinai Icahn School of Medicine, New York, New York
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I.L. Maier
hDepartment of Neurology (I.L.M.), University Medical Center Göttingen, Göttingen, Germany
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J.N. Johnson
aFrom the Department of Neurosurgery and Neurology (A.S., V.M.S., Y.S., J.N.J., J.-K.B., P.K.), Baylor College of Medicine, Houston, Texas
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J.-K. Burkhardt
aFrom the Department of Neurosurgery and Neurology (A.S., V.M.S., Y.S., J.N.J., J.-K.B., P.K.), Baylor College of Medicine, Houston, Texas
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S.R. Chen
iDepartment of Interventional Radiology (S.R.C.), MD Anderson Cancer Center, Houston, Texas.
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P. Kan
aFrom the Department of Neurosurgery and Neurology (A.S., V.M.S., Y.S., J.N.J., J.-K.B., P.K.), Baylor College of Medicine, Houston, Texas
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  • FIG 1.
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    FIG 1.

    Structure of the EmboTrap II device. Three different angles of the EmboTrap II device (the second is rotated 90° and third is rotated 45° further). Courtesy of Cerenovus, part of DePuy Synthes Products, Inc.

  • FIG 2.
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    FIG 2.

    Distribution of sites of vessel occlusion treated. Most occlusions were in M1 (54.3%), followed by the ICA (25.7%), followed by M2 (15.7%) and M3 (2.9%). AcomA indicates anterior communicating artery; PcomA, posterior communicating artery; PCA, posterior cerebral artery; ACA, anterior cerebral artery.

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    FIG 3.

    Angiographic runs of a patient case. A, Preoperative angiogram shows M2 occlusion. B, EmboTrap II deployed across the occlusion. C, Angiogram run after EmboTrap II deployment. D, Angiographic run after EmboTrap II removal.

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    Table 1:

    Baseline characteristics and demographics

    Characteristicsn = 70
    Mean age (range) (yr)69.9 [SD, 16.5] (25–96)
    Women (%)48.6
    Race (%)
        White61.7
        Hispanic28.3
        Black6.7
        Other3.3
    Atrial fibrillation (%)56.9
    Hypertension (%)80.3
    Hyperlipidemia (%)52.4
    Diabetes (%)32.8
    Previous ischemic stroke/TIA (%)20
    Mean NIHSS on admission (range)16.3 [SD, 6.6] (3–27)
    Mean premorbid mRS (range)0.4 [SD, 0.9] (0–4)
    Premorbid mRS ≤2 (%)94.0
    Location
        ICA (%)25.7
        M1 (%)54.3
        M2 (%)15.7
        M3 (%)2.9
        Basilar (%)1.4
    IV tPA (%)34.3
    • View popup
    Table 2:

    Procedural variables

    Variablesn = 70
    Anesthesia type (%)
        Conscious sedation63.2
        General anesthesia36.8
    Balloon-guide catheter used (%)38.6
    Intracranial stent (%)5.7
    Intra-arterial tPA (%)7.1
    Mean No. of passes per treatment (range)2.5 [SD, 1.8] (1–7)
    Mean LKN to puncture time (min)444.7 [SD, 310.4]
    Mean puncture to reperfusion (min)54.2 [SD, 36.0]
    Mean LKN to reperfusion time (min)480.1 [SD, 320.1]
    Mean No. of passes per treatment (range)2.5 [SD, 1.8] (1–7)
    Mean No. of passes per treatment with EmboTrap II as definitive device (%)2.2 [SD, 1.6] (1–7)
    Thrombectomy technique
        SRBG37 (52.9%)
        Solumbra18 (25.7%)
        EPIC15 (21.4%)
    Definitive treatment with alternative device (%)12.9
    • Note:—SRBG indicates stent retriever with balloon guide; EPIC, Embotrap pinning catheter.

    • View popup
    Table 3:

    Clinical and radiographic outcomes

    Outcomesn = 70
    Rate of final successful reperfusion (defined as TICI ≥ 2b reperfusion) (%)95.7
    TICI ≥ 2b rate with EmboTrap II as definitive device (%)82.3
    FPE (%)35.7
    Mean 24-hour NIHSS (range)12.1 [SD, 7.6] (0–32)
    Mean NIHSS at day 5/7 or at discharge10.5 [SD, 11.2] (0–42)
    Mean mRS at discharge3.2 [SD, 1.7] (0–6)
    mRS 0–2 at discharge (%)43.1
    Mean mRS at 90 days2.7 [SD, 2.2] (0–6)
    mRS 0–2 at 90 days (%)52.9
    • View popup
    Table 4:

    Adverse events

    Adverse Events
    Embolization to distal or a new territory (%)15.7
    Hemorrhagic conversion (%)22.9
    Symptomatic hemorrhagic conversion (%)4.3
    Mortality in follow-up period (%)11.4
    • View popup
    Table 5:

    Comparison with prior studies

    Present Study (n = 70)Valente et al9 (n = 29)ARISE II8 (n = 227)SWIFT PRIME4 (n = 98)TREVO 210 (n = 88)
    Stent retrieverEmboTrap IIEmboTrap IIEmboTrapSolitaireTrevo
    Balloon-guide catheter used39%79%74%NRNR
    Mean No. of passes without alternate-device rescue treatment2.21.86NRNR2.4
    Final reperfusion rate (TICI ≥ 2b) without alternative-device rescue treatment82%76%80%83%68%
    FPE (TICI ≥ 2b)36%34%52%NRNR
    90-day mRS ≤ 253%55%67%60%40%
    Mean/median baseline NIHSS16.318.515.81718.3
    Mean/median 24-hour NIHSS10.5NRNRa8.512
    Mean/median procedure time (min)54593624b48
    sICH4%05%07%
    Distal embolization16%07%NR7%
    • Note:—NR indicates not reported.

    • ↵a Neurologic deterioration by ≥4 NIHSS points at 24 hours occurred in 4.5% of patients.

    • ↵b Mean of 24 minutes from groin puncture to stent deployment.

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American Journal of Neuroradiology: 42 (5)
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A. Srivatsan, V.M. Srinivasan, R.M. Starke, E.C. Peterson, D.R. Yavagal, A.E. Hassan, A. Alawieh, A.M. Spiotta, Y. Saleem, K.M. Fargen, S.Q. Wolfe, R.A. de Leacy, I.P. Singh, I.L. Maier, J.N. Johnson, J.-K. Burkhardt, S.R. Chen, P. Kan
Early Postmarket Results with EmboTrap II Stent Retriever for Mechanical Thrombectomy: A Multicenter Experience
American Journal of Neuroradiology May 2021, 42 (5) 904-909; DOI: 10.3174/ajnr.A7067

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Early Postmarket Results with EmboTrap II Stent Retriever for Mechanical Thrombectomy: A Multicenter Experience
A. Srivatsan, V.M. Srinivasan, R.M. Starke, E.C. Peterson, D.R. Yavagal, A.E. Hassan, A. Alawieh, A.M. Spiotta, Y. Saleem, K.M. Fargen, S.Q. Wolfe, R.A. de Leacy, I.P. Singh, I.L. Maier, J.N. Johnson, J.-K. Burkhardt, S.R. Chen, P. Kan
American Journal of Neuroradiology May 2021, 42 (5) 904-909; DOI: 10.3174/ajnr.A7067
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