A Novel Endovascular Robotic System for Treatment of Lower Extremity Peripheral Arterial Disease: First-in-Human Experience

Abstract

Background: To assess the feasibility and first-in-human experience of a novel endovascular robotic system for treatment of lower extremity peripheral arterial disease (PAD). Methods: Between November 2021 and January 2022, consecutive patients with obstructive lower extremity PAD and claudication (Rutherford 2–5) with >50% stenosis demonstrated on angiography were enrolled in this study. Lower extremity peripheral arterial intervention was performed using the endovascular robotic system, which consisted of a bedside unit and an interventional console. The primary endpoints were technical success, defined as the successful manipulation of the lower extremity peripheral arterial devices using the robotic system, and safety. The secondary endpoints were clinical success, defined as 50% residual stenosis at the completion of the robot-assisted procedure without major adverse cardiac events and radiation exposure. Results: In total, 5 patients with PAD were enrolled in this study (69.2±6.0 years; 80% men). The novel endovascular robotic system successfully completed the entire procedure of endovascular treatment of lower extremity PAD. Conversion to manual operation, including advancement, retracement, rotation of the guidewires, catheters, sheaths, deployment, and release of the balloons and stent grafts, was not necessary. We achieved the criteria for clinical procedural and technical success in all patients. No deaths, myocardial infarctions, or ruptures occurred in the period up to 30 days after the procedure, and no device-related complications were observed. The robotic system operator had 97.6% less radiation exposure than that at the procedure table, with a mean of 1.40±0.49 μGy. Conclusions: This study demonstrated the safety and feasibility of the robotic system. The procedure reached technical and clinical performance metrics and resulted in significantly lower radiation exposure to the operators at the console compared with that at the procedure table. Clinical Impact There were some reports about several robotic systems used in the peripheral arterial disease, but no robotic system was able to perform entire procedure of endovascular treatment of lower extremity peripheral arterial disease (PAD). To solve this problem, we designed a remote-control novel endovascular robotic system. It was the first robotic system that can perform entire procedure of endovascular treatment of PAD worldwide. A novelty retrieval report about this is provided in the supplementary materials. The robotic system is compatible with all commercial endovascular surgical devices currently available in the market, including guidewires, catheters and stent delivery systems. It can perform all types of motion, such as forward, backward, and rotation to meet the requirements of all types of endovascular procedures. During the operation, the robotic system can perform these operations in a fine-tuned manner, so it is easy to cross the lesions, which is the key factor influencing the success rate of the operation. In addition, the robotic system can effectively reduce the exposure time to radiation, thereby reducing the risk of occupational injury.