Robotic Peripheral Vascular Intervention With Drug-Coated Balloons is Feasible and Reduces Operator Radiation Exposure: Results of the Robotic-Assisted Peripheral Intervention for Peripheral Artery Disease (RAPID) Study II

Abstract

BACKGROUND: A robotic-assisted platform (CorPath System; Corindus Vascular Robotics) is feasible for peripheral vascular intervention (PVI) for the treatment of femoropopliteal lesions. OBJECTIVES: This study was designed to determine the feasibility and safety of robotic PVI for treating femoropopliteal lesions with drug-coated balloon (DCB), and to evaluate the effect of robotic PVI on operator radiation exposure during robotic PVI. METHODS: This prospective, single-arm trial enrolled patients with symptomatic peripheral arterial disease affecting the femoropopliteal artery. The primary outcome measure was clinical success, defined as <50% residual stenosis and the absence of periprocedural device-related serious adverse events. Operator radiation exposure was compared between the robotic cockpit vs the tableside. RESULTS: This study enrolled 20 patients (age, 65.5 ± 9.9 years; 60% men), with the majority (75%) Rutherford category 3-4. A total of 24 lesions (lesion length, 49.8 ± 37.5 mm) were treated with DCB and 91.7% were located in the superficial femoral artery. Clinical success was 100% and provisional stenting was required in 1 lesion. Fluoroscopy time was 7.3 ± 3.3 minutes and operator radiation exposure was 1.9 ± 2.9 μSv, which was reduced by 96.9 ± 5.0% when compared with the table-side (control) dosimeter (P<.001). There were no adverse events associated with the use of the robotic system. CONCLUSIONS: These data demonstrate the safety and feasibility of using a robotic-assisted platform for treating femoropopliteal lesions with rapid-exchange interventional devices, and show 96.9% reduction in radiation exposure for the primary operator.