PRECISE Published: Robot-Assisted PCI Safe, Feasible

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Key Points:
  • Large multicenter study looks at safety, efficacy of robot-assisted PCI
  • High device, procedural success shown with less radiation exposure to the operator
  • System may also prevent orthopedic injury, physical strain on operators

By L.A. McKeown
Tuesday, April 09, 2013

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A remote-controlled robotic system for performing non-emergent percutaneous coronary intervention (PCI) results in a high rate of technical and procedural success while reducing operator exposure to radiation by 95%, according to findings published in the April 16, 2013, issue of the Journal of the American College of Cardiology.

Results from the Percutaneous Robotically Enhanced Coronary Intervention Study (PRECISE) were first presented in May 2012 at the annual meeting of the Society for Cardiovascular Angiography and Interventions in Las Vegas, NV.

Giora Weisz, MD, of Columbia University Medical Center (New York, NY), and colleagues used the CorPath 200 robotic system (Corindus, Natick, MA) to treat 164 patients undergoing elective PCI at 9 US centers. The system consists of 2 main components:

  • A remote interventional cockpit that is radiation-shielded and can be placed anywhere in the cath lab
  • A bedside unit that delivers and manipulates coronary guidewires, balloons, and stents using a robotic arm under operator direction

All operators trained on the system before enrolling patients in the study.

High Rate of Success, Lower Radiation Exposure

An average of 1.1 ± 0.34 stents were implanted per patient, with post dilatation needed in 20.1%. Mean procedure time using the robotic system was 24.4 minutes, with a fluoroscopy time of 11.1 minutes. The mean patient cumulative dose of radiation was 1.5 ± 0.08 Gy and mean contrast media volume was 144.2 ± 70.4 mL.

There were no device-related complications. Two procedures switched to manual operation because of severe resistance to stent delivery. Conversion to manual operation was immediate and not associated with myocardial ischemia, hemodynamic compromise, or any other complications.

Clinical procedural success, the co-primary endpoint, was achieved in 97.6% of patients, with the lower bound of the 95% confidence interval yielding a performance goal of 94.5%, which was higher than the protocol-specified performance goal of 84% (P < 0.001). Additionally, device technical success, the other co-primary endpoint, was achieved in 98.8%, with the lower bound of the 95% confidence interval yielding a performance goal of 96.2%, which exceeded the protocol-specified goal of 90% (P < 0.001).

Median radiation exposure to operators at the interventional cockpit was 95.2% lower than at the procedure table (0.98 vs. 20.6 µGy; P < 0.0001). Therefore, the powered secondary effectiveness endpoint of a minimum 50% reduction in operator radiation exposure was successfully met.

Health Benefits, Comfort for Operators

To use the robotic system, the interventional cardiologist sits at the cockpit and remotely performs the PCI using the console joysticks or touch-screen buttons. Commands from the control console are delivered through a communication cable running to the robotic drive, on which a sterile cassette is placed. The cassette, which is loaded with the interventional devices and connected to the guiding catheters, imposes axial and rotational forces on the intracoronary devices.

Notably, the system is compatible with all commercially available 0.014-inch guidewires, rapid-exchange coronary angioplasty balloons, and stent delivery systems.

“Remote-controlled robotic systems are expected to reduce occupational hazards to interventional cardiologists,” Dr. Weisz and colleagues write, noting that professional societies are calling for better cath lab safety and lower radiation exposure in light of increasingly complex procedures.

“Interventional cardiologists develop posterior lens opacities and cataracts at younger ages and at higher rates than other professionals,” they point out, adding that observational data have also raised concerns about career-long radiation exposure possibly leading to the development of left-sided brain tumors.

Another unmeasured but potential benefit of the robot-assisted system, they speculate, is prevention of orthopedic injury, since “long hours donning a heavy lead apron while standing may adversely affect interventional cardiologists, resulting in reduced performance and loss of productivity.” Additionally, they note that “[s]itting at the shielded interventional cockpit without the need for a heavy lead apron minimizes back discomfort, allowing the operator to focus on the procedure without being distracted by the physical strain.”

In an email communication with TCTMD, Dr. Weisz added that the use of robotic-enhanced PCI also has potential benefits for patients.

“The procedure is more standardized with enhanced stability of the intravascular devices during the procedure,” he said. “The system can be used for precise measurement of the segment needed to be treated, thus optimizing stent length and procedure efficiency.”

Note: Dr. Weisz and several coauthors of the study are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Source:
Weisz G, Metzger C, Caputo RP, et al. Safety and feasibility of robotic percutaneous coronary intervention: PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) study. J Am Coll Cardiol. 2013;Epub ahead of print.

 

Disclosures:

  • The study was sponsored by Corindus.
  • Dr. Weisz reports no relevant conflicts of interest.

 

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