Unleashing the Potential: First-in-Human Evaluation of Automatic Robotic-Assisted Endovascular Aortic Repair for Standardized Therapies

释放潜能:首次人体评估自动化机器人辅助血管内主动脉修复术在标准化治疗中的应用

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Abstract

Endovascular surgical robots have advanced vascular surgery through the integration of automatic programs for complex interventions. However, current systems still lack full procedural automation capabilities. This single-center single-arm study explores the feasibility and safety of automatic robotic-assisted endovascular aortic repair (EVAR) using a novel surgical algorithm with in vitro and in vivo experiments. The EVAR process was deconstructed into surgical steps and programmed into an endovascular surgical robot, which executed the steps automatically based on parameters derived from image processing software. In vitro experiments using 3D-printed vascular models demonstrated millimeter-level precision, with reduced operation time, fluoroscopy time, and radiation exposure compared to manual robotic control. In vivo evaluations in four patients with abdominal aortic aneurysms achieved 100% technical and clinical success, with no major adverse events. Operation time averaged 110 ± 47 min, fluoroscopy time was 19 ± 6 min, and patient-side radiation exposure was 1251 ± 389 mGy. Surgeon-side radiation exposure was 4 ± 1 mGy. The results indicate that automatic robotic-assisted EVAR can be performed with acceptable accuracy and safety to provide standardized therapies, shorten operation time, and reduce radiation exposure of patients.

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