After FDA Approval, Clinicians Optimistic About Robot-Assisted PCI

In the wake of the US Food and Drug Administration (FDA) approval on July 25, 2012, of a robotic system that enables clinicians to perform percutaneous coronary intervention (PCI) by remote control, physicians interviewed by TCTMD were generally positive. The technology will likely improve operator safety while putting patients at no additional risk, they predicted, although its high cost may be prohibitive for hospitals.

Results from the PRECISE trial, presented May 10, 2012, at the Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions in Las Vegas, NV, showed that the CorPath 200 System (Corindus Vascular Robotics, Natick, MA) is safe and feasible in 164 patients. Device success was 98.8%, with 2 conversions to manual operation. At 30 days there were 4 non-Q-wave MIs (2.4%) but no deaths, Q-wave MI, TVR, or stent thrombosis. Ultimately, the system reduced operator radiation exposure by 95.2%.

Barriers to Adoption

PRECISE primary investigator Giora Weisz, MD, of NewYork-Presbyterian Hospital/Columbia University Medical Center (New York, NY), told TCTMD in a telephone interview that the FDA approval stemmed from the “excellent results” of that trial. “I think it’s a big leap for robotic technologies in the cath lab and being able to bring standardization to PCI and stability to intravascular devices,” he said.

According to Dr. Weisz, multiple centers in the United States have expressed interest in purchasing the system, and he expects more to follow suit. “This is a new technology, and it takes time to convince everyone to see the potential benefit,” he noted. “Like with every technology, there are always a few centers who are early adopters.”

Dr. Weisz characterized the learning curve as “very, very short.” Because interventionalists using the robotic system already know the anatomy and the devices involved, they only need to pick up “a few tips and tricks,” he said, reporting that data to be presented in October 2012 at the Transcatheter Cardiovascular Therapeutics scientific symposium in Miami, FL, shows operators can be proficient after doing 3 cases.

Though he admitted having been skeptical about robot-assisted PCI in the past, Morton J. Kern, MD, of the University of California, Irvine (Irvine, CA), said that trying a demonstration model at the SCAI meeting in May led him to become “a believer that it could do what it said it could do” despite the artificial environment.

“There wasn’t anything that I didn’t like, and I wasn’t convinced until I sat in it that it would work,” he observed. However, for complex procedures, “I’m not sure how skilled and adept [I will be] or how easy the device will be to use.” As such, Dr. Kern stressed the need for more studies looking at complex cases treated robotically to determine clinical safety in routine practice.

With the allegedly high price tag and limited national experience with the device, Dr. Kern was unsure how much the system will be integrated into practice, at least initially. Also, the known benefits of the CorPath 200 only relate to radiation protection for the operator, he said, adding that the main question is, “How much money is radiation protection for the operator worth?”

“So for simple angioplasty, this might be great. But again, that’s a big investment to just save the operator back pain,” Dr. Kern said. “So maybe it will fly, maybe it won’t. This is an opportunity to let the marketplace speak.”

It all comes down to what is economical for the hospital, Dr. Kern concluded. The investment may be worth it for high-volume centers, he said, but not for those whose operators perform only a few cases a week.

Occupational Hazards Not to Be Taken Lightly

But occupational hazards are more serious than some realize, according to Dr. Weisz. “There is evidence that after 20 years of practice, 60% of interventional cardiologists have serious back pain to levels that they are missing workdays,” he said, adding that cataracts and even brain tumors can be an issue.

Dr. Weisz reported that his institution plans to purchase the technology and he looks forward to using it routinely. “At the end of the day I have back pain, and if I could sit inside this interventional cockpit of the CorPath 200 robotic system without my lead [apron], shielded from radiation, I would be less tired,” he related. “If you are less tired, you feel better, have less back pain, and you perform better on the patient.”

 


Source:
Corindus Vascular Robotics. FDA clears first robotic-assisted system for coronary artery disease stent procedures [press release]. http://www.corindus.com/Libraries/PR/Corindus_Press_Release_1.sflb.ashx. Published July 25, 2012. Accessed July 31, 2012.

 

  • Dr. Kern reports serving as a consultant for St. Jude Medical and Volcano.

 

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Disclosures
  • Dr. Weisz reports no relevant conflicts of interest.

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