Safety and efficacy of cerebral robot assisted angiography: randomized comparison of robotic versus manual procedures

Abstract

BACKGROUND: While robotic assisted technology has advanced in cardiovascular interventions, neurovascular applications still lack a robotic system. To assess the safety and efficacy of novel robotic systems designed for cerebral angiography, we conducted a multicenter, randomized controlled non-inferiority trial. METHODS: 130 patients were recruited who received cerebral angiography in four centers. After identifying the target vessels, patients were randomly allocated to an experimental group for robotic procedures and a control group for manual procedures in a 1:1 ratio. Clinical success rate, technical success rate, overall surgery time, pre-puncture set-up time, puncture-to-unsheathed time, mean catheterization time per target vessel, X-ray fluoroscopy time, and primary operator's radiation dose were compared. The safety endpoints were incidence of perioperative vascular injuries, any adverse events, and device malfunctions. RESULTS: 64 patients were assigned to the experimental group and 66 to the control group. Both groups achieved 100% clinical success and a 100% technical success. Significantly, the primary operator's radiation dose in the robotic group was lower than that in the manual group (1.67±3.49 μSv vs 43.63±38.95 μSv, P<0.001). The puncture-to-unsheathed time (P=0.882), mean catheterization time per target vessel (P=0.247), and fluoroscopy time (P=0.701) were comparable. The pre-puncture set-up time in the robotic group was longer (P<0.001), attributed to prolonged robotic instrument set-up. No robot related adverse events were observed. CONCLUSION: The trial showed that the robotic system was safe and effective for assisting cerebral angiography, notably reducing primary operators' radiation exposure. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05778214.