Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Department of Neurosurgery, Hebei Medical University First Affiliated Hospital, Shijiazhuang, Hebei, China.
Stroke Vasc Neurol. 2024 Jun 21;9(3):243-251. doi: 10.1136/svn-2022-002260.
At present, neurointerventional surgery requires angiographers to perform operations in the digital subtraction angiography (DSA) room. Ionising radiation and chronic joint damage are still unavoidable for angiographers. Therefore, we researched and developed a neurointerventional robot-assisted system, which is operated by angiographers in an operating room outside the DSA room. We have conducted a prospective, multicentre, randomised controlled trial to evaluate the safety and efficacy of a robot-assisted system in human cerebral angiography. In the future, this research will provide a platform for the research and development of an intelligent surgical system and bring revolutionary progress in neurointerventional surgery.
From December 2020 to December 2021, 260 patients were enrolled from three medical centres, who were randomly and equally divided into a robot-assisted system group and a clinical routine cerebral angiography group. The success rate of angiography, the rate of the catheter reaching the target vessel, the operation time, X-ray radiation exposure and the incidence of related adverse events were compared between the two groups.
A total of 257 patients completed this trial; baseline characteristics of the two groups did not differ significantly. The success rate of angiography in both the control group and the experimental group was 100%. The rate of the catheter reaching the target vessel was 99.23% and 100.00% in the control and experimental groups, respectively. For the control versus experimental groups, the angiographic operation time was 48.59±25.60 min versus 47.94±27.49 min, respectively; the X-ray radiation dose was 735.01±554.77 mGy versus 821.65±705.45 mGy, respectively; and the incidence of adverse events was 23.44% versus 22.48%, respectively. No statistical differences were present between the two groups.
The robot-assisted surgical system is more convenient for cerebral angiography and is as safe and effective as the traditional cerebral angiography.
目前，神经介入手术需要血管造影师在数字减影血管造影（DSA）室中进行操作。对于血管造影师来说，电离辐射和慢性关节损伤仍然是不可避免的。因此，我们研究开发了一种神经介入机器人辅助系统，该系统由 DSA 室外的手术室中的血管造影师操作。我们进行了一项前瞻性、多中心、随机对照试验，以评估机器人辅助系统在人类脑血管造影中的安全性和有效性。未来，这项研究将为智能手术系统的研究和开发提供一个平台，并为神经介入手术带来革命性的进步。
2020 年 12 月至 2021 年 12 月，从三个医疗中心共招募了 260 名患者，随机平均分为机器人辅助系统组和临床常规脑血管造影组。比较两组的血管造影成功率、导管到达靶血管的比率、手术时间、X 射线辐射暴露和相关不良事件的发生率。
共有 257 名患者完成了这项试验；两组的基线特征无显著差异。对照组和实验组的血管造影成功率均为 100%。导管到达靶血管的比率分别为对照组 99.23%和实验组 100.00%。对于对照组与实验组，血管造影手术时间分别为 48.59±25.60 分钟和 47.94±27.49 分钟；X 射线辐射剂量分别为 735.01±554.77 毫戈瑞和 821.65±705.45 毫戈瑞；不良事件发生率分别为 23.44%和 22.48%。两组之间无统计学差异。
机器人辅助手术系统在脑血管造影中更方便，与传统的脑血管造影一样安全有效。
Zotero 插件