A first-in-man study of the role of flexible robotics in overcoming navigation challenges in the iliofemoral arteries.

OBJECTIVE Current interventional techniques rely heavily on operator familiarity with catheters and wires and on physician skills in effectively navigating through and managing target lesions. A novel robotic technology allows endovascular specialists to remotely control catheter tip deflection and advancement and to coordinate manipulation of currently available wires. The aim of this study was to successfully demonstrate feasibility and safety of navigation to and treatment of iliac and femoral artery lesions using Hansen Medical's vascular control catheter (VCC). METHODS A total of 20 limbs were included in this analysis for a first-in-man trial of the VCC and vascular catheter control system. The local Institutional Review Board approved the trial, and all patients included had symptomatic femoropopliteal occlusive disease. Preoperative imaging was available on all patients. Target lesions in the contralateral superficial femoral artery ranged from mild stenosis to chronic total occlusions (TransAtlantic Inter-Society A through D). Exclusion criteria included previously treated iliac and femoral lesions in the symptomatic leg and a body mass index >35. The operators comprised three experienced interventionalists (two vascular surgeons and an interventional radiologist) and a novice (cardiac surgeon). The primary end point of the study was to demonstrate successful cannulation of the target vessel (ie, navigation to the lesion with wire and catheter) with the Hansen VCC, with no device-related serious adverse events. Secondary end points were to assess the ability to treat lesions using the flexible catheter defined by successful insertion of a guidewire, angiography of the target vessel, delivery of balloon, and/or stent. Procedure times and radiation delivered were analyzed for the group and by operator, and t-test was performed to determine statistical significance. Complications were assessed by clinical examination and ultrasound. RESULTS Lesions were successfully and safely cannulated in all limbs treated. The VCC performed as designed in all cases. All interventionalists, regardless of experience, navigated the VCC with ease. However, statistically significant differences in navigation time and radiation per case were observed between the experienced and inexperienced interventionalists. There were no access site complications (hematoma, thrombosis, pseudoaneurysm) as evaluated by ultrasound. CONCLUSIONS This initial experience in flexible robotics demonstrates that this technology is both efficacious and safe in the arterial tree. Although robotics provides superior maneuverability compared with current techniques, endovascular experience is crucial to taking full advantage of the extra capabilities. Valuable future considerations will include off-the-wall (center lumen) navigation with three-dimensional imaging.