First-in-Human Study Shows Robotically Assisted PCI Safe, Feasible

September 22, 2010

September 22, 2010 (Washington, DC) — It is early days still, but new research suggests that the future of interventional cardiology might see clinicians retreat to the safety of a radiation-protected room while performing PCI with a robotic remote-control system.

The new data, a first-in-human report presented here this week at TCT 2010, showed that robotically assisted PCI (CorPath 200, Corindus, Natick, MA) is technically feasible, with no occurrences of major adverse cardiac events (MACE) at 30 days, and significantly reduced operator exposure to radiation, as well as reduced use of radiation contrast.

Dr Juan Granada

"I think some of the main issues with interventional cardiology are the orthopedic injuries that people don't talk about, the radiation exposure, the quality of the intervention, and contrast use," lead investigator Dr Juan Granada (Cardiovascular Research Foundation, Orangeburg, NY) told heartwire . "What this system is trying to do is optimize the way we do angioplasty procedures and to decrease the risk, mainly the risk that the operator and the personnel are exposed to."

Granada said that it's not uncommon for clinicians to have sore backs, shoulders, hips, and knees, given that they're wearing heavy lead vests while standing to perform increasingly complex procedures. The orthopedic problems range in severity, with some doctors, as noted previously by heartwire , forced into early retirement because of severe spinal problems. Equally, if not more concerning, are the cumulative risks of long-term radiation exposure.

Small Study, But Researchers Optimistic

The robotic remote-control system tested by Granada and colleagues, including Dr Giora Weisz (New York Presbyterian Hospital/Columbia University Medical Center, New York) and researchers at the Corbic Research Institute (Envigado, Colombia), consists of an articulating robotic arm attached to the cath-lab patient table. Rather than stand bedside with conventional PCI, the operator is located within a "shielded interventional cockpit" with the touch screen and joystick controls used to move and manipulate the PCI devices.

"The aim is to be more precise and to provide more control of the procedure," said Granada. "Control includes not only control of the device but also of the environment. You're comfortably sitting down, you can control everything manually. It pretty much provides an automatization of the procedure."

The group tested the feasibility of robotically assisted PCI in eight stable patients undergoing PCI for ischemia. Performance success was high, with operators able to successfully place a balloon or stent in the target lesion. The device was safely extracted without any adverse events, and procedure times were similar to standard PCI. Importantly, operator exposure to radiation was 97% lower than conventional PCI, compared with historical controls, and average contrast use was also lower, an unexpected finding that Granada attributes to better control of the devices with the robotic arm.

To heartwire , Granada said he was initially skeptical of the robotic system, given that operators are efficient at delivering and manipulating guidewires, stents, and balloons during conventional PCI. He was impressed, however, with tactile responsiveness of the system and expects that it would be helpful in long procedures with complex patients.

"You can imagine procedures where you need two wires, ballooning one branch and then the other, and where you have to do a lot of sequential stuff," he said. "You're sitting down, looking at the screen and controlling every single device, so it gives you more comfort and precision and hopefully better patient outcomes."

Next up for the CorPath 200 system is a prospective, multicenter, nonrandomized US study that will test the safety and efficacy of the technology in a larger group of patients. That study, known as Percutaneous Robotically Enhanced Coronary Intervention Study (PRECISE), is led by Weisz and Dr Joseph Carrozza (St Elizabeth's Medical Center, Boston, MA) and is expected next year. Currently, a price tag on the investigational remote-control system has not been set.

There are remote-control systems already used for electrophysiology procedures, including the Artisan Control Catheter/Sensei Robotic Catheter System (Hansen Medical, Mountain View, CA), which has been used in the ablation of atrial fibrillation, and the Stereotaxis Magnetic Navigation System (Stereotaxis, St Louis, MO). In interventional cardiology, one study, reported by heartwire , showed that operators could use the Stereotaxis system to advance and position guidewires across difficult-to-treat coronary lesions.

Granada reports consulting for Medrad and research support from Abbott Vascular, Boston Scientific, Medtronic, Medrad, and Circulite. Weisz reports no conflicts of interest.


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