title: First-in-human evaluation of a novel robotic-assisted coronary angioplasty system.
abstract: OBJECTIVE
  We aimed to evaluate the safety and feasibility of a robotic angioplasty system in delivery and manipulation of coronary guidewires, balloons, and stents in patients undergoing elective percutaneous coronary intervention (PCI).
  
  
  BACKGROUND
  A remote-control, robotic-assisted angioplasty system is under development to address some of the procedural challenges and occupational hazards associated with traditional PCI.
  
  
  METHODS
  Patients with coronary artery disease and clinical indication for elective PCI were enrolled. The coronary angioplasty procedure was performed with the CorPath 200 robotic system (Corindus, Inc., Natick, Massachusetts). The system consists of a remote interventional cockpit and a multicomponent bedside unit that enables the operator to advance, retract, and rotate guidewires and rapid exchange catheters. The primary endpoint was device clinical success (≤ 30% residual stenosis) without in-hospital major adverse cardiac events. Technical success was defined as the ability of the system to complete all the planned angioplasty steps on the basis of procedural segments. Patients were followed up to 30 days after angioplasty procedure.
  
  
  RESULTS
  A total of 8 patients were enrolled in the study. The primary endpoint was achieved in all patients (100%). The technical success of the robotic system was 97.9% in completing 47 of 48 planned steps. There were no device- or procedure-related complications and no in-hospital or 30-day major adverse cardiac events. The operators rated the robotic system performances as equal to or better than manual procedures in 97.5% of the cases. The operator radiation exposure was 97% lower than the levels found at the standard table position.
  
  
  CONCLUSIONS
  Early clinical experience with a robotic-assisted angioplasty system demonstrated feasibility, safety, and procedural effectiveness comparable to manual operation. In addition, the total operator exposure to radiation was significantly low. A larger study is warranted to verify the safety and effectiveness of robotic-assisted percutaneous coronary intervention.
authors.affiliation: Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, New York, New York 10962, USA. jgranada@crf.org
authors.forename: Juan F
authors.initials: JF
authors.lastname: Granada
authors.forename: Juan A
authors.initials: JA
authors.lastname: Delgado
authors.forename: Maria Paola
authors.initials: MP
authors.lastname: Uribe
authors.forename: Andres
authors.initials: A
authors.lastname: Fernandez
authors.forename: Guillermo
authors.initials: G
authors.lastname: Blanco
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Giora
authors.initials: G
authors.lastname: Weisz
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D057785:Catheters; D003105:Colombia; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D012371:Robotics; D015607:Stents; D013813:Therapy, Computer-Assisted / Q000295:instrumentation*; D016896:Treatment Outcome