Results of the PRECISE study show that a robotic system can safely assist interventional cardiologists in performing percutaneous coronary interventions while significantly reducing the physician’s exposure to radiation and improving precision and control. Data from the multicentre, pivotal trial were presented at a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions in Las Vegas, USA (9–12 May 2012).
Giora Weisz, director of Clinical Cardiovascular Research at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, New York, USA, told delegates that during traditional percutaneous coronary intervention procedures, interventional cardiologists are often exposed to significant levels of radiation, as well as physical stresses that place them at risk for orthopaedic problems. Robotically enhanced percutaneous coronary intervention not only has the ability to protect the physician’s health, but can also enhance technical precision, allowing stents to be placed even more precisely, she said.
Weisz presented the results of PRECISE study (CorPath percutaneous robotically enhance coronary intervention study), which investigated the use of the CorPath 200 robotic system. With the system, interventional cardiologists perform percutaneous coronary intervention from a radiation-protected cockpit in a seated position, without the need for the heavy lead apron. The robotic-assisted system provides a precise computer-controlled motion of guidewire and stent to enable the physician to place stents by using a joystick. Additionally, the cockpit provides a better ergonomic position and view of the angiography screens compared to the traditional procedures. This in turn aids the physician in even more accurate measurements.
“Robotically enhanced percutaneous coronary intervention has the potential to benefit both patients and interventional cardiologists,” said Weisz. “This system is designed to place stents with millimetre-level control, while also protecting the physician from radiation exposure.”
In the study, 164 patients at nine sites were treated with robotically enhanced percutaneous coronary intervention using the CorPath 200. Percutaneous coronary intervention was successfully completed without having to convert to manual intervention in 98.8% of patients, without device-related complications. The overall procedure success rate was 97.6% (160/164). Physician exposure to radiation was reduced by 95.2%.
“The PRECISE trial demonstrates robotically assisted percutaneous coronary intervention is safe and feasible for most patients,” said Weisz. “At the same time, robotic treatment can make the procedure safer for the interventional cardiologist as well, by reducing the risk of radiation. In the study, physicians were exposed to significantly lower levels of radiation.”
The PRECISE study was sponsored by Corindus Vascular Robotics.
