Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial

JACC Cardiovasc Interv. 2016 Oct 10;9(19):2058-2064. doi: 10.1016/j.jcin.2016.07.002. Epub 2016 Sep 14.

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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Austria
  • Constriction, Pathologic
  • Contrast Media / administration & dosage
  • Feasibility Studies
  • Female
  • Femoral Artery / diagnostic imaging
  • Femoral Artery / physiopathology
  • Femoral Artery / surgery*
  • Humans
  • Length of Stay
  • Male
  • Middle Aged
  • Operative Time
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / surgery*
  • Popliteal Artery / diagnostic imaging
  • Popliteal Artery / physiopathology
  • Popliteal Artery / surgery*
  • Postoperative Complications / etiology
  • Prospective Studies
  • Radiography, Interventional
  • Robotic Surgical Procedures* / adverse effects
  • Robotic Surgical Procedures* / instrumentation
  • Stents
  • Time Factors
  • Treatment Outcome
  • Vascular Patency
  • Vascular Surgical Procedures / adverse effects
  • Vascular Surgical Procedures / instrumentation
  • Vascular Surgical Procedures / methods*

Substances

  • Contrast Media