WASHINGTON, D.C.—Using a robotic remote control system during PCI may significantly reduce operator radiation exposure, improve patient safety and reduce the amount of contrast media, said Giora Weisz, MD, during a presentation today at the 2010 annual Transcatheter Cardiovascular Therapeutics (TCT) annual conference.
“Contemporary PCI still has multiple weaknesses and challenges. We know that the procedure has limited precision and control … and is associated with longer and more complex procedures and longer procedures are associated with accumulated doses of radiation and spine injury,” said Weisz, co-director of clinical services at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center in New York City.
Currently, an estimated 20 percent of all patients undergoing PCI require a second stent due to the inaccurate placement or sizing of the first stent. Often the devices used to perform these procedures are unstable and lead to the movement of the stent inside the coronary artery, forcing operators to utilize high doses of contrast medium.
Additionally, standard operation procedures, which are not usually ergonomically friendly, can put interventional cardiologists at risk for cataracts and spine injuries. An operator who spends 21-plus years inside the cath lab may increase the chance of acquiring a spine injury by almost 60 percent, Weisz found.
Thus, Weisz asked, “Should we sacrifice ourselves by working in the cath lab or should we find a solution that delivers procedures better, safer and more efficiently without increased risk?”
He and colleagues at the Corbic Research Institute in Envigado, Colombia, performed the first-in-human use of a robotic remote control system to aid PCI—the CorPath 200 (Corindus Vascular Robotics).
The objective of the research was to evaluate the safety and technical efficacy of the CorPath robotic system in manipulating coronary guidewires and stent/balloon systems during PCI. All eight patients enrolled had de novo lesions between 2.5 and 4 mm in diameter and less than 25 mm in length with at least 50 percent stenosis.
The researchers evaluated hospitalization and major adverse cardiac events 24 hours after the procedure, at discharge and 30 days subsequent to the procedure. All patients were treated with a 6F guidewire and either drug-eluting or bare-metal stents between 2.5 mm and 4 mm in diameter and 12.5 mm and 24 mm in length.
“The technical performance of the system was excellent,” noted Weisz.
The technical success rate was 98.6 percent, with only one case failing and calling for researchers to manually remove the wire after completing stent deployment. Additionally, all patients were MACE free at all time points, and no hospitalizations occurred.
A comparison of radiation exposure found that the CorPath system decreased exposure to interventionalists by 97.1 percent compared to standard manual catheter delivery.
Weisz said the robotic arm connects easily to the guiding catheter and decreases operator poor posture and radiation exposure. The system also may benefit the patient, as it “makes procedures a little more precise, efficient and safe.”
The system allows operators to move devices (balloons/catheters) with a precise movement of 1 mm to enable optimal measurement and placement, Weisz said.
“Contemporary PCI is not perfect and can be improved. The CorPath system can improve guiding catheter stability, guidewire manipulation, manage contrast medium injection and improve visualization and stent delivery,” Weisz concluded.
He said indicated the results of the U.S. multicenter PRECISe trial of the technology is on track to be presented at the 2011 TCT symposium.