Background
Percutaneous coronary intervention (PCI) represents the standard treatment for patients with flow-limiting coronary artery disease. Despite its clinical efficacy, conventional manual PCI is associated with several procedural challenges, including high variability in technique, prolonged fluoroscopy times, and thereby considerable radiation exposure to the interventional cardiologist. In the long term, this occupational radiation burden is suggested to contribute to orthopedic strain due to wearing a lead gown and different increased long-term health risks for operators. Robotic-assisted PCI (rPCI) has been developed, to mitigate these limitations, allowing the operator to perform the procedure remotely from a radiation-shielded cockpit. This technological innovation aims to enhance precision and safety and, furthermore minimizing radiation exposure. However, data on the performance of rPCI in the context of complex coronary lesions, particularly regarding radiation exposure and procedure duration, remain scarce.
Methods
This sub-analysis of the randomized ROBO.pci pilot trial evaluated patients with complex coronary lesions, classified as ACC/AHA type B2 or C. Participants were assigned to either robotic-assisted PCI (n = 29) or conventional manual PCI (n = 37). The primary endpoints included operator and assistant radiation exposure, total procedural time, technical success, and contrast medium consumption. Radiation doses were continuously recorded in real time at the operator’s head, thorax, and left hand using a live dosimetry system. Lesion and procedural characteristics were assessed to ensure comparability between groups.
Results
Baseline demographic, clinical, and angiographic characteristics were well balanced between the robotic and manual PCI groups. There were no significant differences in lesion morphology, vessel size, target vessel distribution, or stent parameters. Radiation exposure for the primary operator was markedly lower across all measurement points in the rPCI group. Specifically, mean radiation doses at the head were 1.4 ± 1.1 µSv with rPCI compared to 4.4 ± 4.5 µSv during manual PCI (p = 0.001). Similarly, exposure at the thorax was reduced from 9.5 ± 10.4 µSv (manual) to 3.0 ± 2.6 µSv (robotic; p = 0.002), and at the left hand from 13.9 ± 20.9 µSv to 2.8 ± 2.5 µSv (p = 0.007). Radiation levels for assisting personnel were numerically lower in the rPCI group, although these differences did not reach statistical significance. While total procedure duration was longer with robotic assistance (rPCI: 2811.8 ± 904.2 seconds vs. mPCI: 2254.8 ± 1024.4 seconds; p = 0.025), no differences were observed in contrast agent usage. Importantly, no major procedural complications occurred in either group.
Conclusion
Robotic-assisted PCI significantly reduces radiation exposure for operators without compromising procedural safety or technical success, even in complex coronary lesions. Although the total procedure time was prolonged, the ergonomic and occupational safety advantages of robotic systems are evident. These results highlight the potential of rPCI to improve working conditions for interventional cardiologists while maintaining procedural quality and patient outcomes. The findings support the feasibility of implementing robotic systems in routine clinical practice and provide a foundation for larger, outcome-focused trials to further evaluate their long-term clinical and occupational benefits.
