First-in-human evaluation of an independently developed Chinese robot-assisted system for percutaneous coronary intervention.
J Geriatr Cardiol
; 19(10): 743-752, 2022 Oct 28.
Article
en En
| MEDLINE
| ID: mdl-36338278
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Tipo de estudio:
Guideline
Idioma:
En
Revista:
J Geriatr Cardiol
Año:
2022
Tipo del documento:
Article