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.

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.