Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial
Ehtisham Mahmud, Florian Schmid, Peter Kalmar, Hannes Deutschmann, Franz Hafner, Peter Rief, Marianne Brodmann, Ehtisham Mahmud, Florian Schmid, Peter Kalmar, Hannes Deutschmann, Franz Hafner, Peter Rief, Marianne Brodmann
Abstract
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.
Keywords: PVI; interventions; peripheral artery disease; robotic assisted.
Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed