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Mahmud, E; Schmid, F; Kalmar, P; Deutschmann, H; Hafner, F; Rief, P; Brodmann, M.
Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial.
JACC Cardiovasc Interv. 2016; 9(19):2058-2064
Doi: 10.1016/j.jcin.2016.07.002
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Web of Science
PubMed
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- Co-authors Med Uni Graz
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Brodmann Marianne
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Deutschmann Hannes
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Hafner Franz
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Kalmar Peter
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Rief Peter
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- Abstract:
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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.
A robotic-assisted platform for percutaneous coronary intervention is available for treating coronary artery disease.
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.
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.
These data demonstrate the feasibility and safety of using a robotic-assisted platform for performing peripheral arterial revascularization.
Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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Aged -
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Austria -
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Constriction, Pathologic -
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Contrast Media - administration & dosage
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Feasibility Studies -
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Female -
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Femoral Artery - diagnostic imaging
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Femoral Artery - physiopathology
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Femoral Artery - surgery
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Humans -
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Length of Stay -
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Male -
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Middle Aged -
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Operative Time -
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Peripheral Arterial Disease - diagnostic imaging
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Peripheral Arterial Disease - physiopathology
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Peripheral Arterial Disease - surgery
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Popliteal Artery - diagnostic imaging
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Popliteal Artery - physiopathology
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Popliteal Artery - surgery
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Postoperative Complications - etiology
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Prospective Studies -
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Radiography, Interventional -
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Robotic Surgical Procedures - adverse effects
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Robotic Surgical Procedures - instrumentation
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Stents -
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Time Factors -
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Treatment Outcome -
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Vascular Patency -
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Vascular Surgical Procedures - adverse effects
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Vascular Surgical Procedures - instrumentation
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Vascular Surgical Procedures - methods
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interventions
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peripheral artery disease
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PVI
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robotic assisted