PRECISE: Robotically enhanced PCI feasible for many patients
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A robotic, remote-control procedure demonstrated technical and clinical effectiveness for interventional cardiologists performing percutaneous coronary interventions while significantly reducing physician exposure to radiation and improving precision and control.
Results of the late-breaking PRECISE multicenter pivotal study were presented at the Society for Cardiovascular Angiography and Interventional Scientific Sessions.
Giora Weisz
Courtesy of SCAI
Researchers evaluated and safety and effectiveness of the CorPath 200 robotic system (Corindus Inc.) in the delivery and manipulation of coronary guidewires, balloons and stents. Using the robotic system, interventional cardiologists perform PCI from a radiation-protected cockpit in a seated position, without the need for a heavy lead apron. The robotic-assisted system provides a computer-controlled motion of guidewire and stent to enable the physician to place stents by using a joystick. The cockpit provides a better ergonomic position and view of the angiography screens compared with traditional procedures, according to a press release.
The study enrolled 164 patients at nine sites who had CAD and clinical indication for PCI. All patients were followed for 30 days after the procedure.
Robotically assisted PCI was completed successfully, with conversion to manual operation, in 98.8% of patients. Clinical procedural success was achieved in 97.6% of patients. Per-procedural non-Q wave MI occurred in only four patients (2.4%). No device-related complications occurred, nor were there any reports of death, stroke, Q-wave MI or revascularization at 30 days after procedure.
For the operator, physician exposure to radiation was reduced by 95.2%, according to the release.
The researchers concluded that CorPath 200 robotic system was associated with effectiveness comparable to manual operation.
“Robotically enhanced PCI has the potential to benefit both patients and interventional cardiologists,” Giora Weisz, MD, director of clinical CV research at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center, said in the release. “This system is designed to place stents with millimeter-level control, while also protecting the physician from radiation exposure.”
For more information:
- Weisz G. Late-breaking clinical trials. Presented at: the Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 9-12, 2012; Las Vegas.
Disclosure: The PRECISE study was sponsored by Corindus Vascular Robotics. Dr. Weisz and the researchers report no relevant financial disclosures.