A multi-device robotic-assisted PCI system: a proof-of concept study for left main bifurcation stenting with culotte technique in a porcine model

Abstract

Background and purpose: Robotic-assisted percutaneous coronary intervention (PCI) has been increasingly used for simple lesion. For complex lesions, extensive manual intervention is still required. This study aims to verify the stability and safety of this robot system in complex lesion under fifth-generation (5G) network before clinical trial. Methods: We developed a robotic system that allows simultaneous remote control of multiple devices using a 5G wireless network. The key feature of the system is a bionic thumb along with two-bionic forefingers. The system was tested in eight pigs (six over 18.3 km and two over 1,100 km). Two stents were placed in the left main bifurcation using the culotte technique. All procedures, barring device loading onto the robot system, including manipulation of the guiding catheter, wire adjustments, stent or balloon positioning, and notably the final kissing step, were conducted remotely. Results: The rate of procedure success was 100%, with no device-related complications. In comparison to short-distance remote control, the delay with long-distance remote control was minimal (90.9 ± 1.5 vs. 81.5 ± 2.7 ms for command data transmission; 163.2 ± 1.3 vs. 161.0 ± 1.4 ms for image transmission). The procedure time was shorter when using two pairs versus a single pair of bionic fingers (104.3 ± 10.2 vs. 126.0 ± 3.9 min), primarily due to less time needed for device loading and exchange (33.1 ± 4.2 vs. 56.1 ± 4.0 min). Conclusions: With the 5G network, long distance was not a significant barrier for robotic-assisted PCI for chronic total occlusion. A design of the independent bionic finger module enabled final kissing balloon inflation with reduced requirement for manual intervention. Whether the system could be used beyond left main bifurcation lesions requires further investigation.