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Randomized Controlled Trial Multicenter Study
Middle Meningeal Artery Embolization for Nonacute Subdural Hematoma.
- Jianmin Liu, Wei Ni, Qiao Zuo, Heng Yang, Ya Peng, Zhiqing Lin, Zhenbao Li, Jiyue Wang, Yong Zhen, Jing Luo, Yuanxiang Lin, Jian Chen, Xuming Hua, Hua Lu, Ming Zhong, Mingfa Liu, Jianmin Zhang, Yang Wang, Jieqing Wan, Yi Li, Tianxiao Li, Guohua Mao, Wenyuan Zhao, Liang Gao, Conghui Li, E Chen, Xin Cheng, Ping Zhang, Zigao Wang, Lei Chen, Yongxin Zhang, Bing Tian, Fang Shen, Yu Lei, Yina Wu, Yanjiang Li, Guoli Duan, Liquan Xu, Nan Lv, Jian Yu, Xiaolong Xu, Zhuoying Du, Hongjian Zhang, Jin Hu, Zifu Li, Qiang Yuan, Yu Zhou, Gang Wu, Lei Zhang, Chao Gao, Dongwei Dai, Xuehai Wu, Yongwei Zhang, Hanqiang Jiang, Rui Zhao, Jiabin Su, Yi Xu, Johanna Maria Ospel, MajoieCharles B L MCBLMFrom the Neurovascular Center (J. Liu, Q.Z., P.Z., L.C., Yongxin Zhang, F.S., Y. Wu, G.D., N.L., X.X., Zifu Li, Y. Zhou, L.Z., D.D., Yongwei Zhang, R.Z., Y.X., Q.L., P.Y.), Trauma Center (J. Liu, Q.Z.), and Department of Radiology (, Mayank Goyal, Qiang Li, Pengfei Yang, Yuxiang Gu, Ying Mao, and MAGIC-MT Investigators.
- From the Neurovascular Center (J. Liu, Q.Z., P.Z., L.C., Yongxin Zhang, F.S., Y. Wu, G.D., N.L., X.X., Zifu Li, Y. Zhou, L.Z., D.D., Yongwei Zhang, R.Z., Y.X., Q.L., P.Y.), Trauma Center (J. Liu, Q.Z.), and Department of Radiology (B.T.), Naval Medical University Changhai Hospital, the Key Laboratory of Molecular Neurobiology of the Ministry of Education, Naval Medical University (J. Liu, P.Y.), the Oriental PanVascular Devices Innovations College, University of Shanghai for Science and Technology (J. Liu, H.Z., P.Y.), the Departments of Neurosurgery (W.N., H.Y., J.Y., Z.D., J.H., Q.Y., G.W., C.G., X.W., H.J., J.S., Y.G., Y.M.) and Neurology (X.C., Z.W.), and the National Center for Neurological Disorders (Y.G., Y.M.), Fudan University Huashan Hospital, the Department of Neurosurgery, Fudan University Huashan Hospital North (Y. Lei, Yanjiang Li, L.X.), Neurosurgical Institute Fudan University and Shanghai Clinical Medical Center of Neurosurgery (Y.G., Y.M.), the Department of Neurosurgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (X.H.), the Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University (J. Wan), the Department of Neurosurgery, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Yi Li), and the Department of Neurosurgery, Shanghai Tenth People's Hospital (L.G.), Shanghai, the Department of Neurosurgery, First People's Hospital of Changzhou, Changzhou (Y.P.), the Department of Neurosurgery, First Affiliated Hospital of Ningbo University, Ningbo (Z. Lin), the Department of Neurosurgery, Yijishan Hospital, the First Affiliated Hospital of Wannan Medical College, Wuhu (Zhenbao Li), the Department of Neurosurgery, Liaocheng People's Hospital, Liaocheng (J. Wang), the Department of Neurosurgery, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Yangzhou (Y. Zhen), the Department of Neurosurgery, First Affiliated Hospital of Anhui Medical University, Hefei (J. Luo), the Department of Neurosurgery, First Affiliated Hospital of Fujian Medical University, Fuzhou (Y. Lin), the Department of Neurosurgery, Affiliated Hospital of Nantong University, Nantong (J.C.), the Department of Neurosurgery, Jiangsu Provincial Hospital, the First Affiliated Hospital of Nanjing Medical University, Nanjing (H.L.), the Department of Neurosurgery, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (M.Z.), the Department of Neurosurgery, Shantou Central Hospital, Shantou (M.L.), the Department of Neurosurgery, Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou (J.Z.), the Department of Neurosurgery, Capital Medical University Beijing Chaoyang Hospital, Beijing (Y. Wang), the Department of Neurosurgery, Henan Provincial People's Hospital, Zhengzhou (T.L.), the Department of Neurosurgery, Second Affiliated Hospital of Nanchang University, Nanchang (G.M.), the Department of Neurosurgery, Zhongnan Hospital Wuhan University, Wuhan (W.Z.), the Department of Neurosurgery, the First Hospital of Hebei Medical University, Shijiazhuang (C.L.), and the Department of Neurosurgery, Zhongshan Hospital Xiamen University, Xiamen (E.C.) - all in China; the Departments of Diagnostic Imaging (J.M.O.), Radiology (M.G.), and Clinical Neurosciences (M.G.), University of Calgary, Calgary, AB, Canada; and the Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam (C.B.L.M.M.).
- N. Engl. J. Med. 2024 Nov 21; 391 (20): 190119121901-1912.
BackgroundThe effect of embolization of the middle meningeal artery in patients with subacute or chronic subdural hematoma is uncertain.MethodsWe performed a multicenter, open-label, randomized trial in China, involving patients with symptomatic nonacute subdural hematoma with mass effect. Patients were assigned to undergo burr-hole drainage or receive nonsurgical treatment at the surgeon's discretion, and patients in each group were then randomly assigned, in a 1:1 ratio, to undergo middle meningeal artery embolization with liquid embolic material or to receive usual care. Patients whose condition warranted craniotomy were excluded. The primary outcome was symptomatic recurrence or progression of subdural hematoma within 90 days after randomization. Secondary outcomes included clinical and imaging outcomes. The main safety outcome was any serious adverse event (including death).ResultsThe analysis included 722 patients, of whom 360 were assigned to the embolization group and 362 to the usual-care group. Burr-hole drainage was performed in 78.3% of the enrolled patients; among the patients who underwent burr-hole drainage, the procedure occurred after embolization in 99.6%. Symptomatic recurrence or progression of subdural hematoma within 90 days occurred in 24 patients (6.7%) in the embolization group and in 36 (9.9%) in the usual-care group (between-group difference, -3.3 percentage points; 95% confidence interval, -7.4 to 0.8; P = 0.10). The incidence of serious adverse events was lower in the embolization group than in the usual-care group (6.7% vs. 11.6%, P = 0.02).ConclusionsAmong patients with symptomatic nonacute subdural hematoma (of whom 78% underwent burr-hole drainage), middle meningeal artery embolization resulted in a 90-day incidence of symptomatic recurrence or progression similar to that with usual care but was associated with a lower incidence of serious adverse events. (Funded by Shanghai Shenkang Hospital Development Center and others; MAGIC-MT ClinicalTrials.gov number, NCT04700345.).Copyright © 2024 Massachusetts Medical Society.
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