LAS VEGAS—A robotic remote-control coronary intervention system demonstrated technical and clinical effectiveness comparable to manual operation, but the operator exposure to radiation was significantly lower, based on PRECISE, a late breaking clinical trial presented May 10 at the 35th annual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).
The CorPath 200 System (Corindus Vascular Robotics of Natick, Mass.,) allows for procedure control from an interventional cockpit, providing robotic-assisted placement of coronary guidewires and stent/balloon catheters. The system consists of a remote interventional cockpit and a bedside disposable cassette that enables the operator to advance, retract and rotate guidewires and exchange catheters.
“With the system, the entire procedure can take place without lead aprons, with the operators seated behind radiation-shielded panels and can manipulate the stent, guidewire or balloon through joysticks,” explained principal investigator Giora Weisz, MD, director of Clinical Cardiovascular Research at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York City. Also, the system can use automatic contrast injectors, which may save on contrast volume and potentially costs, he added.
“Why do we need such a device?” questioned Weisz, during a press conference. First, he said that this system could potentially help eliminate human error in PCI procedures because it has millimeter-level control, which could improve patient outcomes. Second, “operators endure many physical injuries by working extended hours in the cath lab wearing lead vests.”
He pointed out that 60 percent of interventional cardiologists report serious back and spine injury after 20 years of practice. Also, there is increased incidence of cataracts for interventionalists at an earlier age. Finally, a recent study found that direct exposure to radiation during PCI procedures may be resulting in a greater number of left-side brain tumors for interventionalists (EuroIntervention 2012;7:1081-1086).
The objectives of this study were to evaluate the safety as well as the clinical and technical effectiveness of the robotic system in the delivery and manipulation of coronary guidewires, balloons and stents. The primary endpoint was clinical procedural success, defined as less than 30 percent residual stenosis at the completion of the procedure of robotic treated lesions, in the absence of major adverse coronary events. Device technical success was defined as the successful advancement and retrieval of the PCI devices (guidewire, balloon and stent) by using the system without conversion to manual operation. All patients were clinically followed for 30 days.
In the study, the researchers treated 164 patients at nine sites with robotically enhanced PCI using the CorPath 200. PCI was successfully completed without having to convert to manual PCI in 98.8 percent of patients, without device-related complications. The overall procedure success rate was 97.6 percent, while only 2.4 percent had peri-procedural non-Q wave MI. No death, stroke, Q-wave MI, or revascularization occurred in the 30 days post-procedures.
For the effect on the operator, the median reduction in radiation exposure to the operator was 94.8 percent lower than the levels found at the standard table position.
Using the system did not increase the procedural time of the PCI, Weisz told Cardiovascular Business. However, the interventionalists in the trial underwent previous training on pig models. “After about three procedures—or about 45 minutes—most of the operators are experts,” he added.
“PRECISE demonstrated that robotically assisted PCI 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 next step for researchers is to evaluate the system’s cost-effectiveness. As with many new technologies, adoption of the system may ultimately depend on its price tag.
“Since the system is not yet approved in the U.S., we cannot yet divulge the cost,”