Once just a feature of science fiction, robotics is now an integral part of the current healthcare landscape. With the advent of robotic-assisted percutaneous coronary intervention (PCI), interventional cardiology may be poised to experience a tectonic shift.
In less than 40 years, interventional cardiology has gone from the first angioplasty, pioneered by Andreas Gruentzig, MD, to a field that features some of the most technologically advanced medicine being practiced today. Not only has the field expanded into realms beyond the coronary anatomy, but also into entirely new ways to perform the procedure, like robotic-assisted PCI.
Physicians performing robotic PCI no longer need to stand next to the cath lab table, exposing themselves to harmful radiation and orthopedic injury from prolonged use of heavy, leaded aprons and guards. From a shielded cockpit, physicianss can use two joysticks to control the placement of coronary guidewires, stents and balloon catheters, all while maintaining distance and protection from the source of radiation.
“This is a fantastic, new, revolutionary technology,” says Ehtisham Mahmud, MD, chief of cardiovascular medicine at UC San Diego Health. “It’s the first new way in how we do the procedure, which hasn’t changed in nearly 40 years. I’ve been using the system for about 18 months for all types of cardiac interventions, including complex coronary interventions, with the exception of cases requiring an atherectomy or complex CTO device.”
When tested in the prospective, multicenter, open-label, non-randomized PRECISE trial, robotic-assisted PCI showed favorable outcomes. The 164-patient trial found rates of technical success and clinical procedural success, the two primary endpoints, of 98.8 percent and 97.6 percent, respectively.
“The primary endpoints were better than we anticipated and better than what we could expect from similar, but non-robotically PCI studies,” says Giora Weisz, MD, principal investigator of the PRECISE trial. “Our expectations were for a success rate of around 92 percent or 93 percent… so we were very pleased.”
According to Weisz, who is associate professor of medicine at Columbia University Medical Center, New York, and chairman of cardiology at Shaare Zedek Medical Center, Jerusalem, the study also examined operator radiation exposure and found a 95 percent reduction with the robotic-assisted PCI system when compared with the measurement of radiation at the tableside where the operator would have stood if not using the system.
As a result of these findings, the FDA granted 510(k) clearance to the first robotic-assisted PCI system in 2012.
A safer cath lab
Proponents of robotics in interventional cardiology, like Mahmud, are quick to emphasize how transformative the robotic system has been in their practice.
“When we are performing [robotic-assisted] PCI, I’m shielded in the cockpit and most of the team steps away, so there is a dramatic and significant reduction in radiation exposure to everyone,” Mahmud says. “You also don’t wear lead, which can cause operator fatigue, spine injuries and other occupational hazards associated with the practice of interventional cardiology.”
As chief administrative officer for medicine and cardiovascular services of UC San Diego Health, Lisa Murphy, MBA, CPA, is well acquainted with the day-to-day cost of running the lab and says she has been encouraged by the quality of life benefits observed with the robotic-assisted PCI system.
“[Dr. Mahmud] is our chief and coworker and team member and we want him to be safe,” Murphy says. “So that is the biggest pro for us and obviously the clinical results are high up there as well.”
To date, the benefits have focused on the physicians who are closest to the table, and thus the associated radiation, rather than nurses and staff.
Lloyd W. Klein, MD, professor of medicine at Rush Medical College, Chicago, and founding member of the Multispecialty Occupational Health Group, adds that the control of the robotic system is another benefit.
“It has precise controls—I’d say even more precise than what human hands are able to do,” Klein says. “For example, in turning the wire, there are 36 clicks to a revolution, which means you have 36 different orientations you can give the tip of the wire. And that is certainly far more than I can do and I suspect far more than what any human mechanically can do. So to the extent that that is an advantage, it is a big advantage.”
Weisz agrees. “With the robotic