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Efficacy and safety of a neurointerventional operation robotic assistance system in cerebral angiography

He Liu, Conghui Li, Shaohua Ren, Tong Li, Hongliang Zhong, Jianwen Jia, Hongchao Yang, Yi Qi, Junqiang Feng, Youxiang Li, Yang Wang
DOI: 10.1136/svn-2022-002260 Published 23 August 2023
He Liu
1Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
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Conghui Li
2Department of Neurosurgery, Hebei Medical University First Affiliated Hospital, Shijiazhuang, Hebei, China
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Shaohua Ren
3Department of Neurosurgery, Shanxi Provincial People’s Hospital, Shanxi, Taiyuan, China
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Tong Li
1Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
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Hongliang Zhong
1Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
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Jianwen Jia
1Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
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Hongchao Yang
1Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
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Yi Qi
1Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
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Junqiang Feng
1Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
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Youxiang Li
4Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
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Yang Wang
1Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
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Article Figures & Data

Figures

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  • Figure 1
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    Figure 1

    Experiment flowchart. FAS=number of people randomly enrolled−number of people who did not use any research equipment; PPS=FAS lost to follow-up or the patient withdraws from the study; SS=FAS−number without any safety assessment (lost to follow-up). FAS, full analysis set, PPS, per-protocol set, SS, safety analysis set.

  • Figure 2
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    Figure 2

    The basic structure of the robot assistant system. (A) a Disposable accessories, b Operating arm, c Control cabinet, d Workstation, e Operation console. (B) Inside the solid line: the operating room. Inside the dotted line: the control device room. (C) The robot working in the operating room. (D) The neurointerventionalist was controlling the robot outside of the operating room (in the control device room).

Tables

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  • Table 1

    Baseline demographics

    IndexExperimental groupControl groupP value
    Age, years
     Number of cases (number of missing)128 (0)130 (0)0.4903
      Mean±SD53.82±9.9754.72±10.99
    Sex, n (%)
     Number of cases (number of missing)128 (0)130 (0)0.1987
      Male48 (37.50)59 (45.38)
      Female80 (62.50)71 (54.62)
    Nationality, n (%)
     Number of cases (number of missing)128 (0)130 (0)0.0592
      Han nationality124 (96.88)130 (100.0)
      Others4 (3.13)0 (0.00)
    Height (cm)
     Number of cases (number of missing) 119(9) 122(8)0.9883
      Mean±SD165.93±7.73165.92±7.87
    Weight (Kg)
     Number of cases (number of missing)119(9)123(7)0.1134
      Mean±SD70.99±10.6168.66±12.15
    BMI (Kg/m2)
     Number of cases (number of missing)119(9)122(8)0.0362
      Mean±SD25.74±3.1224.85±3.38
    • BMI, body mass index.

  • Table 2

    The main evaluation index—angiographic success rate analysis results (FAS)

    IndexExperimental groupControl groupStatisticsP value
    Whether the angiography was successful
     Number of cases (number of missing)128 (0)130 (0)NANA
     Yes n (%)128 (100.00)130 (100.00)
     No n (%)0 (0.00)0 (0.00)
    RD (test-control) and 95% CI 0.00 (−0.03 to 0.03)
    Whether the catheter was in place
     Number of cases (number of missing)128 (0)129 (1)Fisher1.0000
     Yes n (%)128 (100.00)129 (99.23)
     No n (%)0 (0.00)1 (0.77)
    RD (test - control) and 95% CI 0.01 (−0.02 to 0.04)
    Whether target vessel imaging was successful
     Number of cases (number of missing)128 (0)129 (1)Fisher1.0000
     Yes n (%)128 (100.00)129 (99.23)
     No n (%)0 (0.00)1 (0.77)
    RD (test−control) and 95% CI 0.01 (−0.02 to 0.04)
    • FAS, full analysis set; RD, rate difference.

  • Table 3

    The main evaluation index—angiographic success rate analysis results (PPS)

    IndexExperimental groupControl groupStatisticsP value
    Whether the angiography was successful
     Number of cases (number of missing)128 (0)129 (0)NANA
     Yes n (%)128 (100.00)129 (100.00)
     No n (%)0 (0.00)0 (0.00)
    RD (test–control) and 95% CI 0.00 (−0.03 to 0.03)
    Whether the catheter was in place
     Number of cases (number of missing)128 (0)129 (0)Fisher1.0000
     Yes n (%)128 (100.00)128 (99.22)
     No n (%)0 (0.00)1 (0.78)
    RD (test–control) and 95% CI 0.01 (0.02 to 0.04)
    Whether target vessel imaging was successful
     Number of cases (number of missing)128 (0)129 (0)Fisher1.0000
     Yes n (%)128 (100.00)128 (99.22)
     No n (%)0 (0.00)1 (0.78)
    RD (test–control) and 95% CI 0.01 (-0.02, 0.04)
    • PPS, per-protocol set; RD, rate difference.

  • Table 4

    Operating time analysis results (FAS)

    IndexExperimental groupControl groupStatisticsP value
    Operation time (min)
     Number of cases (number of missing)128 (0)130 (0)t=0.200.8432
     Mean±SD47.94±27.4948.59±25.60
     Median45.0045.00
     Q1, Q328.50, 60.5030.00, 64.00
     Min, max7.00, 173.005.00, 138.00
    • FAS, full analysis set.

  • Table 5

    Operating time analysis results (PPS)

    IndexExperimental groupControl groupStatisticsP value
    Operation time (min)
     Number of cases (number of missing)128 (0)129 (0)t=0.170.8646
     Mean±SD47.94±27.4948.5±25.68
     Median45.0045.00
     Q1, Q328.50, 60.5030.00, 64.00
     Min, max7.00, 173.005.00, 138.00
    • PPS, per-protocol set.

  • Table 6

    The results of radiation dose analysis (SS) of the subject

    IndexExperimental groupControl groupStatisticsP value
    Subject’s X-ray radiation dose (mGy) 
     Number of cases (number of missing)124 (4)124 (5)t=1.080.2834
     Mean±SD735.01±554.77821.65±705.45
     Median505.30582.50
     Q1,Q3417.50, 926.55495.55, 965.71
     Min, max233.63, 4940.56216.50, 7138.93
    • SS, safety analysis set.

Supplementary Materials

  • Figures
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  • Additional Files
  • Supplementary data

    [svn-2022-002260supp001.pdf]

  • Supplementary data

    [svn-2022-002260supp002.pdf]

  • Supplementary video

    [svn-2022-002260supp003.MP4]

Additional Files

  • Figures
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  • Supplementary Materials
  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

    • Data supplement 1
    • Data supplement 2
    • Data supplement 3
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Efficacy and safety of a neurointerventional operation robotic assistance system in cerebral angiography
He Liu, Conghui Li, Shaohua Ren, Tong Li, Hongliang Zhong, Jianwen Jia, Hongchao Yang, Yi Qi, Junqiang Feng, Youxiang Li, Yang Wang
Stroke and Vascular Neurology Aug 2023, svn-2022-002260; DOI: 10.1136/svn-2022-002260

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Efficacy and safety of a neurointerventional operation robotic assistance system in cerebral angiography
He Liu, Conghui Li, Shaohua Ren, Tong Li, Hongliang Zhong, Jianwen Jia, Hongchao Yang, Yi Qi, Junqiang Feng, Youxiang Li, Yang Wang
Stroke and Vascular Neurology Aug 2023, svn-2022-002260; DOI: 10.1136/svn-2022-002260
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Efficacy and safety of a neurointerventional operation robotic assistance system in cerebral angiography
He Liu, Conghui Li, Shaohua Ren, Tong Li, Hongliang Zhong, Jianwen Jia, Hongchao Yang, Yi Qi, Junqiang Feng, Youxiang Li, Yang Wang
Stroke and Vascular Neurology Aug 2023, svn-2022-002260; DOI: 10.1136/svn-2022-002260
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