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Clinical Outcomes On Tubridge Flow Diverter in Treatmenting Intracranial Aneurysms: a Retrospective Multicenter Registry Study

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Abstract

Purpose

In China, the application of nitinol Tubridge flow diverter (TFD) has become popular for treating intracranial aneurysms (IAs). In this study, we investigated the safety outcomes of the application of TFD for treating IAs in real-world scenarios.

Methods

We retrospectively analyzed aneurysms treated with TFD in 235 centers throughout China between April 2018 and April 2020. The primary endpoint was the event-free survival rate at 12 months, defined as the occurrence of morbidity (spontaneous rupture, intraparenchymal hemorrhage (IPH), ischemic stroke, and permanent cranial neuropathy) or death. Univariate and multivariate analyses were performed to assess the risk factors. A good outcome was defined as a modified Rankin Score (mRS) of 0–2.

Results

We included 1281 unruptured aneurysms treated with TFD. The overall neurological morbidity and death rates after 12 months were 5.4 and 2.8%, respectively. Ischemic strokes were the most common complication (4.2%, P < 0.001). Cranial neuropathy, IPH, and spontaneous rupture occurred in 0.3%, 0.3%, and 0.5% of aneurysms, respectively. Univariate and multivariate analyses indicated that the male gender, older age, larger aneurysm diameter, and aneurysm located on BA were the independent risk factors for neurologic events. Aneurysm located on BA was the independent risk factor for ischemic strokes. Most patients (1222) had access to the mRS, and 93.2% of them achieved good outcomes.

Conclusion

Treatment of IAs with TFD was associated with low morbidity and mortality, most of which were ischemic events. Large posterior aneurysms might be associated with a higher complication rate.

Trial Registration

Retrospectively registered.

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Data Availability Statement

All data generated or analyzed during this study are included in this article.

Abbreviations

CEC:

Clinical events committee

IA:

Intracranial aneurysms

IPH:

Intraparenchymal hemorrhage

mRS:

Modified Rankin Scored

SAE:

Serious adverse events

TFD:

Tubridge flow diverter

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Acknowledgements

We gratefully acknowledge Professor Xiao yan Yan (Department of Medical Statistics, Peking University, Bei Jing, China) for providing guidance on the various statistical methods used in this study. We are grateful to all principal investigators and delegated physicians who enrolled the required participants in all the participating centers. We also thank the participants, their medical caretakers, and the families who consented to participate in the trial.

Funding

This work was supported by the Project of the Shanghai Science and Technology Commission [grant number 19DZ1930300] and the Training Program for Excellent Young Clinical Medical Talents in Hongkou District [grant number HKLCYQ2024-05]; and was sponsored by unrestricted grants from the MicroPort NeuroTech (Shanghai) Co., Ltd. (N/A).

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Authors and Affiliations

  1. Neurovascular Center, Changhai Hospital, Naval Medical University, 168 Changhai Road, 200433, Shanghai, China

    Qiang Li, Nan Lv, Pengfei Yang, Yu Zhou, Rui Zhao, Wenjin Yang, Guoli Duan, Yina Wu, Qian Zheng, Zifu Li, Qiao Zuo, Dongwei Dai, Qinghai Huang, Bo Hong, Yi Xu & Jianmin Liu

  2. Department of Neurovascular Disease, Shanghai Fourth People’s Hospital, School of Medicine, Tongji University, 200080, Shanghai, China

    Deyuan Zhu & Yibin Fang

  3. Beijing Tiantan Hospital, Capital Medical University, 100070, Beijing, China

    Ming Lv

  4. Henan Provincial People’s Hospital, 463599, Zhengzhou, China

    Tianxiao Li

  5. Zhongnan Hospital of Wuhan University, 430071, Wuhan, China

    Wenyuan Zhao

  6. The First Affiliated Hospital, Sun Yat-sen University, 510080, Guangzhou, China

    Tiewei Qi

  7. Xiangya Hospital Central South University, 410008, Changsha, China

    Weixi Jiang

  8. Zhujiang Hospital of Southern Medical University, 510280, Guangzhou, China

    Chuanzhi Duan

  9. Qilu Hospital of Shandong University, 250012, Jinan, China

    Guangyu Zhao

  10. Huashan Hospital Affiliated to Fudan University, 200020, Shanghai, China

    Yuxiang Gu

  11. The First Affiliated Hospital of Zhengzhou University, 450052, Zhengzhou, China

    Sheng Guan

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  1. Qiang Li
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  2. Deyuan Zhu
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Contributions

Q. Li: Data curation, Writing—Original draft preparation, Supervision; D. Zhu: Data curation, Writing—Original draft preparation; N. Lv: Data curation, Writing—Original draft preparation; P. Yang: Supervision; Y. Zhou: Supervision; R. Zhao: Supervision; W. Yang: Supervision; M. Lv: Visualization, Investigation; T. Li: Visualization, Investigation; W. Zhao: Visualization, Investigation; T. Qi: Visualization, Investigation; W. Jiang: Visualization, Investigation; C. Duan: Visualization, Investigation; G. Zhao: Visualization, Investigation; G. Duan: Software, Validation; Y. Wu: Software, Validation; Q. Zheng: Software, Validation; Z. Li: Software, Validation; Q. Zuo: Software, Validation; D. Dai: Software, Validation; Y. Fang: Software, Validation; Q. Huang: Visualization, Investigation; B. Hong: Writing—Reviewing and Editing; Y. Xu: Writing—Reviewing and Editing; Y. Gu: Conceptualization, Methodology, Software, Writing—Reviewing and Editing; S. Guan: Conceptualization, Methodology, Software, Writing—Reviewing and Editing; J. Liu: Conceptualization, Methodology, Software, Writing—Reviewing and Editing. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Jianmin Liu.

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Conflict of interest

Q. Li, D. Zhu, N. Lv, P. Yang, Y. Zhou, R. Zhao, W. Yang, M. Lv, T. Li, W. Zhao, T. Qi, W. Jiang, C. Duan, G. Zhao, G. Duan, Y. Wu, Q. Zheng, Z. Li, Q. Zuo, D. Dai, Y. Fang, Q. Huang, B. Hong, Y. Xu, Y. Gu, S. Guan and J. Liu declare that they have no competing interests.

Ethical standards

For this article no studies with human participants or animals were performed by any of the authors. All studies mentioned were in accordance with the ethical standards indicated in each case. This research obtained ethics approval from Shanghai Changhai Hospital Ethics Committee (Approval ID CHEC2022-229). Local institutional review boards or ethics committees authorized the study and retrospective data collection from patients. A waiver of informed consent by an institutional review board or ethics committee. If necessary, written informed consent was obtained from each patient.

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The authors Qiang Li, Deyuan Zhu and Nan Lv contributed equally to the manuscript.

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Li, Q., Zhu, D., Lv, N. et al. Clinical Outcomes On Tubridge Flow Diverter in Treatmenting Intracranial Aneurysms: a Retrospective Multicenter Registry Study. Clin Neuroradiol (2024). https://doi.org/10.1007/s00062-024-01393-4

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