Guo Wenying, Song Chao, Bao Junmin, Xia Shibo, Zhang Lei, Wang Kundong, Li Haiyan, Zhu Longtu, Lu Qingsheng
Department of Vascular Surgery, Changhai Hospital, Navy Military Medical University (Second Military Medical University), Shanghai, People's Republic of China.
Department of Instrument Science and Engineering, Shanghai Jiao Tong University, Shanghai, People's Republic of China.
J Endovasc Ther. 2025 Feb;32(1):18-28. doi: 10.1177/15266028231182027. Epub 2023 Jul 7.
To assess the feasibility and first-in-human experience of a novel endovascular robotic system for treatment of lower extremity peripheral arterial disease (PAD).
Between November 2021 and January 2022, consecutive patients with obstructive lower extremity PAD and claudication (Rutherford 2-5) with >50% stenosis demonstrated on angiography were enrolled in this study. Lower extremity peripheral arterial intervention was performed using the endovascular robotic system, which consisted of a bedside unit and an interventional console. The primary endpoints were technical success, defined as the successful manipulation of the lower extremity peripheral arterial devices using the robotic system, and safety. The secondary endpoints were clinical success, defined as 50% residual stenosis at the completion of the robot-assisted procedure without major adverse cardiac events and radiation exposure.
In total, 5 patients with PAD were enrolled in this study (69.2±6.0 years; 80% men). The novel endovascular robotic system successfully completed the entire procedure of endovascular treatment of lower extremity PAD. Conversion to manual operation, including advancement, retracement, rotation of the guidewires, catheters, sheaths, deployment, and release of the balloons and stent grafts, was not necessary. We achieved the criteria for clinical procedural and technical success in all patients. No deaths, myocardial infarctions, or ruptures occurred in the period up to 30 days after the procedure, and no device-related complications were observed. The robotic system operator had 97.6% less radiation exposure than that at the procedure table, with a mean of 1.40±0.49 μGy.
This study demonstrated the safety and feasibility of the robotic system. The procedure reached technical and clinical performance metrics and resulted in significantly lower radiation exposure to the operators at the console compared with that at the procedure table.
There were some reports about several robotic systems used in the peripheral arterial disease, but no robotic system was able to perform entire procedure of endovascular treatment of lower extremity peripheral arterial disease (PAD).To solve this problem, we designed a remote-control novel endovascular robotic system. It was the first robotic system that can perform entire procedure of endovascular treatment of PAD worldwide. A novelty retrieval report about this is provided in the supplementary materials.The robotic system is compatible with all commercial endovascular surgical devices currently available in the market, including guidewires, catheters and stent delivery systems. It can perform all types of motion, such as forward, backward, and rotation to meet the requirements of all types of endovascular procedures. During the operation, the robotic system can perform these operations in a fine-tuned manner, so it is easy to cross the lesions, which is the key factor influencing the success rate of the operation. In addition, the robotic system can effectively reduce the exposure time to radiation, thereby reducing the risk of occupational injury.
评估一种用于治疗下肢外周动脉疾病（PAD）的新型血管内机器人系统的可行性和人体首次应用经验。
在2021年11月至2022年1月期间，连续纳入血管造影显示有>50%狭窄的下肢阻塞性PAD且有间歇性跛行（卢瑟福分级2 - 5级）的患者。使用由床边单元和介入控制台组成的血管内机器人系统进行下肢外周动脉介入治疗。主要终点为技术成功，定义为使用机器人系统成功操作下肢外周动脉器械，以及安全性。次要终点为临床成功，定义为在机器人辅助手术完成时残余狭窄50%，且无重大不良心脏事件和辐射暴露。
本研究共纳入5例PAD患者（69.2±6.0岁；80%为男性）。新型血管内机器人系统成功完成了下肢PAD血管内治疗的整个过程。无需转换为手动操作，包括导丝、导管、鞘管的推进、回撤、旋转，以及球囊和覆膜支架的部署和释放。我们在所有患者中均达到了临床手术和技术成功的标准。术后30天内未发生死亡、心肌梗死或破裂，也未观察到与器械相关的并发症。机器人系统操作员的辐射暴露比手术台处减少了97.6%，平均为1.40±0.49微戈瑞。
本研究证明了该机器人系统的安全性和可行性。该手术达到了技术和临床性能指标，与手术台处相比，显著降低了控制台操作员的辐射暴露。
有一些关于在外周动脉疾病中使用几种机器人系统的报道，但没有一种机器人系统能够完成下肢外周动脉疾病（PAD）血管内治疗的整个过程。为解决这个问题，我们设计了一种遥控新型血管内机器人系统。它是全球首个能够完成PAD血管内治疗整个过程的机器人系统。补充材料中提供了关于此的新颖性检索报告。该机器人系统与市场上目前所有商用血管内手术器械兼容，包括导丝、导管和支架输送系统。它可以执行所有类型的动作，如前进、后退和旋转，以满足所有类型血管内手术的要求。在手术过程中，机器人系统可以以微调的方式执行这些操作，因此很容易穿过病变部位，这是影响手术成功率的关键因素。此外，机器人系统可以有效减少辐射暴露时间，从而降低职业伤害风险。
