A novel endovascular robotic-assisted system for endovascular aortic repair: first-in-human evaluation of practicability and safety

Abstract

Objectives To assess the practicability and safety of a novel endovascular robotic system for performing endovascular aortic repair in human. Methods A prospective observational study was conducted in 2021 with 6 months post-operative follow-up. Patients with aortic aneurysms and clinical indications for elective endovascular aortic repair were enrolled in the study. The novel developed robotic system is applicable for the majority of commercial devices and various types of endovascular surgeries. The primary endpoint was technical success without in-hospital major adverse events. Technical success was defined as the ability of the robotic system to complete all procedural steps based on procedural segments. Results The first-in-human evaluation of robot-assisted endovascular aortic repair was performed in five patients. The primary endpoint was achieved in all patients (100%). There were no device- or procedure-related complications or no in-hospital major adverse events. The operation time and total blood loss in these cases were equal to those in the manual procedures. The radiation exposure of the surgeon was 96.5% lower than that in the traditional position while the radiation exposure of the patients was not significantly increased. Conclusions Early clinical evaluation of the novel endovascular aortic repair in endovascular aortic repair demonstrated practicability, safety, and procedural effectiveness comparable to manual operation. In addition, the total radiation exposure of the operator was significantly lower than that of traditional procedures. Clinical relevance statement This study applies a novel approach to perform the endovascular aortic repair in a more accurate and minimal-invasive way and lays the foundation for the perspective automation of the endovascular robotic system, which reflects a new paradigm for endovascular surgery. Key Points • This study is a first-in-human evaluation of a novel endovascular robotic system for endovascular aortic repair (EVAR). • Our system might reduce the occupational risks associated with manual EVAR and contribute to achieving a higher degree of precision and control. • Early evaluation of the endovascular robotic system demonstrated practicability, safety, and procedural effectiveness comparable to that of manual operation.