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  • Computer-assisted microcatheter shaping for intracranial aneurysm embolization: evaluation of safety and efficacy in a multicenter randomized controlled trial

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New devices and techniques
Original research
Computer-assisted microcatheter shaping for intracranial aneurysm embolization: evaluation of safety and efficacy in a multicenter randomized controlled trial
  1. Heng Yang1,2,3,
  2. Wei Ni1,2,3,
  3. Liquan Xu1,2,3,
  4. Jiewen Geng4,5,
  5. Xuying He6,
  6. Huajun Ba7,
  7. Jianjun Yu8,
  8. Lan Qin9,
  9. Yin Yin9,
  10. Yufei Huang9,
  11. Hongqi Zhang4,5,
  12. Yuxiang Gu1,2,3
  1. 1 Department of Neurosurgery, Fudan University Huashan Hospital, Shanghai, Shanghai, China
  2. 2 National Center for Neurological Disorders, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
  3. 3 Shanghai Clinical Medical Center of Neurosurgery, Shanghai, People's Republic of China
  4. 4 China International Neuroscience Institute (China-INI), Beijing, People's Republic of China
  5. 5 Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, People's Republic of China
  6. 6 Neurosurgery Center, Department of Cerebrovascular Surgery, Engineering Technology Research Center of Education Ministry of China on Diagnosis and Treatment of Cerebrovascular Disease, Zhujiang Hospital, Southern Medical University, Guangzhou, People's Republic of China
  7. 7 Department of Neurosurgery, The Central Hospital of Wenzhou City, Wenzhou, People's Republic of China
  8. 8 Department of Neurosurgery, Linyi People's Hospital, Linyi, People's Republic of China
  9. 9 Department of R&D, UnionStrong (Beijing) Technology Co.Ltd, Beijing, People's Republic of China
  1. Correspondence to Dr Yuxiang Gu, Department of Neurosurgery, Huashan Hospital Fudan University, Shanghai, Shanghai, 200040, China; guyuxiang1972{at}126.com; Dr Hongqi Zhang, Department of Neurology, Xuanwu Hospital, Capital Medical University, Bejing, 100176, People's Republic of China; xwzhanghq{at}163.com

Abstract

Background This study aimed to evaluate the efficacy, stability, and safety of computer-assisted microcatheter shaping (CAMS) in patients with intracranial aneurysms.

Methods A total of 201 patients with intracranial aneurysms receiving endovascular coiling therapy were continuously recruited and randomly assigned to the CAMS and manual microcatheter shaping (MMS) groups. The investigated outcomes included the first-trial success rate, time to position the microcatheter in aneurysms, rate of successful microcatheter placement within 5 min, delivery times, microcatheter stability, and delivery performance.

Results The rates of first-trial success (96.0% vs 66.0%, P<0.001), successful microcatheter placement within 5 min (96.04% vs 72.00%, P<0.001), microcatheter stability (97.03% vs 84.00%, P=0.002), and ‘excellent’ delivery performance (45.54% vs 24.00%, P<0.001) in the CAMS group were significantly higher than those in the MMS group. Additionally, the total microcatheter delivery and positioning time (1.05 minutes (0.26) vs 1.53 minutes (1.00)) was significantly shorter in the CAMS group than in the MMS group (P<0.001). Computer assistance (OR 14.464; 95% CI 4.733 to 44.207; P<0.001) and inflow angle (OR 1.014; 95% CI 1.002 to 1.025; P=0.021) were independent predictors of the first-trial success rate. CAMS could decrease the time of microcatheter position compared with MMS, whether for junior or senior surgeons (P<0.001). Moreover, computer assistance technology may be more helpful in treating aneurysms with acute angles (p<0.001).

Conclusions The use of computer-assisted procedures can enhance the efficacy, stability, and safety of surgical plans for coiling intracranial aneurysms.

  • Aneurysm
  • Coil

Data availability statement

Data are available in a public, open access repository.

https://doi.org/10.1136/jnis-2023-020104

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    Data availability statement

    Data are available in a public, open access repository.

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    Footnotes

    • HY and WN contributed equally.

    • Contributors HY and LX designed and performed the experiments and analyzed the data. JG and YY processed the data. HY and WN drafted the manuscript. YY, YH and LQ contributed to collection of documents, software processing, preparation of the 3D aneurysm model, disinfection, and other preoperative preparations. YG, WN and HZ participated in the surgery and revised the manuscript. XH, HB and JY participated in the surgery and intraoperative evaluation. YG responsible for the overall content as the guarantor.

    • Funding This work was financially supported by grants 2014CB541604, 2016YFC1301704, and 2016YFSF110141 from the National Ministry of Science and Technology; grants 81500987, 817712374, 81801155, 81870917, and 82101397 from the National Natural Science Foundation of China; grant SHDC2020CR1018B from Shanghai Shenkang Hospital Development Center; grant 2018SHZDZX03 from the Shanghai Municipal Science and Technology Major Project; and grant 2016YFC1300800 from the National Key R&D Program of China.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.