Preliminary Study Explores Feasibility of Performing Robotic PCI From a Remote Location

With the assistance of robotics, there may come a time when interventional cardiologists are able to perform PCI on patients who are miles away, but one of the first steps toward developing “telestenting” is showing that operators do not have to be in the same room as the patient.

Researchers led by Ryan Madder, MD (Spectrum Health, Grand Rapids, MI), have demonstrated just that, achieving technical and procedural success rates of 86.4% and 95.0%, respectively, in the preliminary REMOTE-PCI study of 20 patients treated by an operator in an isolated room.

“What we’ve shown is that it’s feasible for a physician—using telecommunications and a robotic system—to actually perform PCI on a patient successfully from outside the confines of a procedure room,” Madder told TCTMD.

“This concept of telestenting has potential applications, but a lot of additional study needs to be done,” he continued. “There are still many barriers that need to be overcome, and I think this is just one small step towards this ultimate goal of maybe being able to do PCIs over very long distances.”

Robotic PCI was first approved by the US Food and Drug Administration in July 2012 with the clearance of the CorPath 200 system (Corindus Vascular Robotics). The system involves a bedside robotic arm controlled by an operator at a workstation in the corner of the cath lab. In the PRECISE study, robotic PCI was associated with technical and procedural success rates of 98.8% and 97.6%, respectively, and a 95% reduction in radiation exposure for the operator.

The current study, published in the January 2017 issue of EuroIntervention, builds on that concept by removing the operator from the cath lab entirely. For all procedures, an interventional cardiologist achieved arterial access, performed diagnostic angiography, and seated the guide catheter before moving to a workstation in an isolated room about 55 feet from the patient to perform the procedure. The operator communicated with a nurse and technician in the cath lab via telecommunications devices connected by Wi-Fi.

For safety, a second interventional cardiologist remained in the cath lab but did not manipulate guidewires or catheters in any of the cases.

Between December 2014 and September 2015, 20 patients were treated as part of the study: six presenting with MI, 13 with unstable angina, and one with stable symptoms. The median procedure time was 29 minutes, and the median fluoroscopy time was 15.5 minutes. Radiation exposure for the patients was not higher in the participants compared with a propensity-matched group who underwent standard robotic PCI.

Technical success, defined as the successful advancement and retraction of guidewires, balloons, and stents by the robotic system without the need to convert to a manual procedure, was attained in 19 of 22 lesions. In two of three technically unsuccessful cases, operators were able to place stents manually. In the third case, however, manual manipulation was not successful. That patient came back to the cath lab about 1 month later and underwent a successful procedure with the assistance of rotational atherectomy.

Thus, only that one patient did not meet criteria for procedural success, which was defined as less than 30% residual stenosis at the end of the procedure without death or repeat revascularization before discharge.

The Need for Telestenting

Madder pointed out two ways in which telestenting could fulfill an unmet need: by improving PCI access in regions where many patients do not live within a reasonable distance from a PCI center and by providing an alternative to using lytics and transferring patients with STEMI from a non-PCI-capable center to one equipped to perform primary PCI.

He noted that a 2012 study showed that, on average, 80% of Americans live within a 60-minute drive from a PCI hospital. However, that proportion fell below 40% in more sparsely populated states, which often have significant geographic obstacles—in addition to longer driving times—with which to contend.

“There is a need for us to develop novel approaches to overcome some of these barriers, and [telestenting] may be one approach,” Madder said.

But he acknowledged that there is much more work to be done before telestenting becomes a viable option. In particular, a wireless robotic system needs to be developed because the current system still requires that the robotic arm and the workstation remain connected by cables. Madder said his team is actively working on creating a wireless system, which will be bench-tested and then evaluated in animal models.

Other issues that need to be worked out if the operator is at a remote location, he said, are who will be in the cath lab to handle complications and who will obtain arterial access, perform angiography, and seat the guiding catheter, actions that cannot be performed by current robotic technology. The most obvious choice, Madder suggested, would be a noninterventional cardiologist.

In an accompanying editorial, Paul Cummins, BSc, and Nico Bruining, PhD (Erasmus Medical Center, Rotterdam, the Netherlands), point out some additional challenges that need be addressed in order for telestenting to become a reality. These include technical difficulties in transmitting high-quality images in real time and issues surrounding the protection of private patient information.

Nevertheless, they write, “the novel concept of robotics and telestenting is intriguing and is deserving of our unswerving attention, not only in terms of the techniques themselves, but also in terms of fulfill­ing the highest standards of safety and ethics.”