Evaluation of Performance of Robotic-Assisted Coronary Angioplasty System Over Conventional/Manual PCI

Abstract

Most percutaneous coronary intervention (PCI) might present hazards for patients, procedure operators, and the laboratory staff [1-3]. Due to complex nature of lesions and procedures, both patients and laboratory team may be subjected to exposure of longer procedural duration and radiation [3]. The long hours of standing for operators while wearing a lead apron commonly leads to exhaustion and injuries that frequently results in reduced performance and sub optimal clinical results [1]. A remote-control, robotic-assisted angioplasty system was developed to address some of the procedural challenges and occupational hazards associated with traditional PCI in addition to enhancing the degree of precision and control for the interventional procedure. A remote- control, robotic-assisted angioplasty system is used to address some of the procedural challenges and occupational hazards associated with traditional PCI. The objective of this study was to assess the safety and feasibility of the operating robotic system in patients undergoing elective PCI. This review summarises the safety and feasibility of a robotic angioplasty system in delivery and manipulation of coronary guidewires, balloons, and stents in patients undergoing PCI. 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.) The operating system consists of a remote interventional cockpit and a multicomponent bedside unit that contains advance, retract, and rotate guidewires within rapid exchange catheters. The primary endpoint was device clinical success (30% residual stenosis) with- out in-hospital major adverse cardiac events. The procedural success was defined as the ability of the system to complete all the planned angioplasty steps based on procedural segments.30 days follow up after angioplasty procedure was done. A total of 47 patients were enrolled in the study. Primary endpoint had been achieved in all patients. The success of the robotic system was 98.1% in completing 48 of 49 planned steps. No device or procedure-related complications were reported and no in-hospital or 30-day major adverse cardiac events were observed. We rated the robotic system performances as equal to as or better than manual procedures in 97.7% of the cases. Cardiologist’s radiation exposure was 97% lower than found at the standard table position. Our procedure results demonstrated better safety, feasibility and procedural effectiveness than manual operation. Besides, total operator exposure to radiation was quite low. However, a larger study is warranted to confirm the safety and effectiveness of robotic-assisted percutaneous coronary intervention.