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First-in-human evaluation of an independently developed Chinese robot-assisted system for percutaneous coronary intervention
- Source :
- J Geriatr Cardiol
- Publication Year :
- 2022
-
Abstract
- 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 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.
- Subjects :
- Research Article
Subjects
Details
- ISSN :
- 16715411
- Volume :
- 19
- Issue :
- 10
- Database :
- OpenAIRE
- Journal :
- Journal of geriatric cardiology : JGC
- Accession number :
- edsair.pmid..........634f16d494900c237bbadb92eba33b9a