Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial
Ehtisham Mahmud1, Florian Schmid2, Peter Kalmar2
1Division of Cardiovascular Medicine, Sulpizio Cardiovascular Center, University of California, San Diego, La Jolla, California.
Objectives:
The goal of this study was to evaluate the feasibility and safety of a robotic-assisted platform (CorPath 200, Corindus Vascular Robotics, Waltham, Massachusetts) for treating peripheral artery disease.
Background:
A robotic-assisted platform for percutaneous coronary intervention is available for treating coronary artery disease.
Methods:
In this prospective single-arm trial, patients with symptomatic peripheral artery disease (Rutherford class 2 to 5) affecting the femoropoplital artery were enrolled. Endpoints evaluated were: 1) device technical success, defined as successful cannulation of the target vessel with the robotic system; 2) device safety, defined as absence of device related serious adverse event (hospitalization, prolonged hospitalization, life threatening, or resulted in death); and 3) clinical procedural success, defined as <50% residual stenosis without an unplanned switch to manual assistance or device-related serious adverse event in the periprocedural period.
Results:
The study enrolled 20 subjects (65.5 ± 9.3 years of age; 70% male) with primarily Rutherford class 2 to 3 (90%) symptoms. A total of 29 lesions (lesion length: 33.1 ± 15.5 mm) were treated with the majority (89.7%) being located in the superficial femoral artery. Device technical success, safety and clinical procedural success were all 100% with provisional stenting required in 34.5% of lesions. Fluoroscopy time (7.1 ± 3.2 min) and contrast use (73.3 ± 9.2 ml) compared favorably with studies in similar patient cohorts. There were no adverse events associated with the use of the robotic system.
Conclusions:
These data demonstrate the feasibility and safety of using a robotic-assisted platform for performing peripheral arterial revascularization.
