Please cite this article as: ZHAI GY, CHEN Z, LIU RF, GUO YH, WANG JL, SUN TN, XIE J, HUANG T, ZHOU YJ. First-in-human evaluation of an independently developed Chinese robot-assisted system for percutaneous coronary intervention. J Geriatr Cardiol 2022; 19(10): 743−752. DOI: 10.11909/j.issn.1671-5411.2022.10.002

Citation: Please cite this article as: ZHAI GY, CHEN Z, LIU RF, GUO YH, WANG JL, SUN TN, XIE J, HUANG T, ZHOU YJ. First-in-human evaluation of an independently developed Chinese robot-assisted system for percutaneous coronary intervention. J Geriatr Cardiol 2022; 19(10): 743−752. DOI: 10.11909/j.issn.1671-5411.2022.10.002 doi: 10.11909/j.issn.1671-5411.2022.10.002 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, China

2.

Beijing WeMed Medical Equipment Co., Ltd., Beijing, China

More Information Corresponding author: azzyj12@163.com Available Online: 2022-09-30 Publish Date: 2022-10-28 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.

References [1] Klein LW, Tra Y, Garratt KN, et al. Occupational health hazards of interventional cardiologists in the current decade: results of the 2014 SCAI membership survey. Catheter Cardiovasc Interv 2015; 86: 913−924. doi: 10.1002/ccd.25927 [2] Goldstein JA, Balter S, Cowley M, et al. Occupational hazards of interventional cardiologists: prevalence of orthopedic health problems in contemporary practice. Catheter Cardiovasc Interv 2004; 63: 407−411. doi: 10.1002/ccd.20201 [3] Roguin A. Brain tumours among interventional cardiologists: a call for alarm? Eur Heart J 2012; 33: 1850−1851. doi: 10.1093/eurheartj/ehs159 [4] Granada JF, Delgado JA, Uribe MP, et al. First-in-human evaluation of a novel robotic-assisted coronary angioplasty system. JACC Cardiovasc Interv 2011; 4: 460−465. doi: 10.1016/j.jcin.2010.12.007 [5] Weisz G, Metzger DC, Caputo RP, et al. Safety and feasibility of robotic percutaneous coronary intervention: PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) study. J Am Coll Cardiol 2013; 61: 1596−1600. doi: 10.1016/j.jacc.2012.12.045 [6] Mahmud E, Naghi J, Ang L, et al. Demonstration of the safety and feasibility of robotically assisted percutaneous coronary intervention in complex coronary lesions: results of the CORA-PCI study (Complex Robotically Assisted Percutaneous Coronary Intervention). JACC Cardiovasc Interv 2017; 10: 1320−1327. doi: 10.1016/j.jcin.2017.03.050 [7] Bezerra HG, Mehanna E, W Vetrovec G, et al. Longitudinal geographic miss (LGM) in robotic assisted versus manual percutaneous coronary interventions. J Interv Cardiol 2015; 28: 449−455. doi: 10.1111/joic.12231 [8] Grüntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med 1979; 301: 61−68. doi: 10.1056/NEJM197907123010201 [9] Beyar R, Gruberg L, Deleanu D, et al. Remote-control percutaneous coronary interventions: concept, validation, and first-in-humans pilot clinical trial. J Am Coll Cardiol 2006; 47: 296−300. doi: 10.1016/j.jacc.2005.09.024 [10] Costa MA, Angiolillo DJ, Tannenbaum M, et al. Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial). Am J Cardiol 2008; 101: 1704−1711. doi: 10.1016/j.amjcard.2008.02.053 [11] Patel TM, Shah SC, Soni YY, et al. Comparison of robotic percutaneous coronary intervention with traditional percutaneous coronary intervention: a propensity score-matched analysis of a large cohort. Circ Cardiovasc Interv 2020; 13: e008888. doi: 10.1161/CIRCINTERVENTIONS.119.008888 [12] Yang X, Wang H, Sun L, et al. Operation and force analysis of the guide wire in a minimally invasive vascular interventional surgery robot system. Chin J Mech Eng 2015; 28: 249−257. doi: 10.3901/CJME.2014.1229.181 [13] Dou KF, Song CX, Mu CW, et al. Feasibility and safety of robotic PCI in China: first in man experience in Asia. J Geriatr Cardiol 2019; 16: 401−405. doi: 10.11909/j.issn.1671-5411.2019.05.004 [14] Guo SX. [Current systems and research directions for robot-based endovascular intervention]. Life Sci Instru 2013; 11: 3−12. [In Chinese]. doi: 10.3969/j.issn.1671-7929.2013.05.001 [15] Feng ZQ, Hou ZG, Bian GB, et al. [Master-slave interactive control and implementation for minimally invasive vascular interventional robots]. Acta Autom Sin 2016; 42: 696−705. [In Chinese]. doi: 10.16383/j.aas.2016.c150577 [16] Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol 2018; 72: 2231−2264. doi: 10.1016/j.jacc.2018.08.1038 Proportional views