First-in-human evaluation of an independently developed Chinese robot-assisted system for percutaneous coronary intervention

作     者：Guang-Yao ZHAI Zheng CHEN Rui-Fang LIU Yong-He GUO Jian-Long WANG Tie-Nan SUN Jing XIE Tao HUANG Yu-Jie ZHOU Guang-Yao ZHAI;Zheng CHEN;Rui-Fang LIU;Yong-He GUO;Jian-Long WANG;Tie-Nan SUN;Jing XIE;Tao HUANG;Yu-Jie ZHOU

作者机构：Department of CardiologyBeijing Anzhen HospitalCapital Medical UniversityBeijing Institute of Heart Lung and Blood Vessel DiseaseBeijing Key Laboratory of Precision Medicine of Coronary Atherosclerotic DiseaseClinical Center for Coronary Heart DiseaseCapital Medical UniversityBeijingChina Beijing WeMed Medical Equipment Co.Ltd.BeijingChina 

出 版 物：《Journal of Geriatric Cardiology》 (老年心脏病学杂志（英文版）)

年 卷 期：2022年第19卷第10期

页      面：743-752页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：supported by the National Natural Science Foundation of China(No.7212027,No.7214223) the National Key Research and Development Program of China(2017YFC0908800) the Beijing Municipal Health Commission(PXM2020_026272_000002,PXM2020_026272_000014) 

主　　题：coronary robot system 

摘      要：BACKGROUND Several studies have proved the safety and feasibility of robot-assisted percutaneous coronary intervention(PCI)in reducing the occupational hazards of interventionists while achieving precision ***,an independently developed robot-assisted system for PCI in China has not yet *** study aimed to evaluate the safety and feasibility of a robot-assisted system for elective PCI in *** This preclinical trial included 22 experimental pigs and preliminarily supported the safety and feasibility of the ETcath200 robot-assisted system for ***,eleven patients with coronary heart disease who met the inclusion criteria and had clinical indications for elective PCI were *** was performed using a robot-assisted *** primary outcomes were clinical success(defined as visual estimated residual stenosis30%after PCI and no major adverse cardiovascular events during hospitalization and within 30 days after PCI)and technical success(defined as the ability to use the robot-assisted system to complete PCI successfully without conversion to the traditional manual PCI).RESULTS Eleven patients were included in this clinical trial.A drug-eluting stent with a diameter of 3 mm(interquartile range:2.75–3.5 mm)and a length of 26 mm(interquartile range:22–28 mm)was deployed in all *** clinical success rate was 100%,with no PCI-related complications and no in-hospital or 30-day major adverse cardiovascular events,and the technical success rate was 100%.CONCLUSIONS The results strongly suggest that the use of the independently developed robot-assisted system in China for elective PCI is feasible,safe,and effective.