First-in-human evaluation of an independently developed Chinese robot-assisted system for percutaneous coronary intervention
Guang-Yao ZHAI1
Zheng CHEN1
Rui-Fang LIU1
Yong-He GUO1
Jian-Long WANG1
Tie-Nan SUN1
Jing XIE2
Tao HUANG2
Yu-Jie ZHOU1
1.Department of Cardiology,Beijing Anzhen Hospital,Capital Medical University,Beijing Institute of Heart Lung and Blood Vessel Disease,Beijing Key Laboratory of Precision Medicine of Coronary Atherosclerotic Disease,Clinical Center for Coronary Heart Disease,Capital Medical University,Beijing,China2.Beijing WeMed Medical Equipment Co.,Ltd.,Beijing,China
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 medicine. However, an independently developed robot-assisted system for PCI in China has not yet emerged. This study aimed to evaluate the safety and feasibility of a robot-assisted system for elective PCI in China.METHODS This preclinical trial included 22 experimental pigs and preliminarily supported the safety and feasibility of the ETcath200 robot-assisted system for PCI. Then, eleven patients with coronary heart disease who met the inclusion criteria and had clinical indications for elective PCI were enrolled. PCI was performed using a robot-assisted system. The primary outcomes were clinical success (defined as visual estimated residual stenosis < 30％ 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 patients. The clinical success rate was 100％, with no PCI-related complications and no in-hospital or 30-day major adverse cardiovascular events, and the technical suc-cess 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.
机标关键词：percutaneousevaluationchinesesystemcoronarydevelopedfirst-in-humanindependently
论文发表日期：2022-10-28
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）
页数：10( 743-752 )