TCT 2017: Could doctors perform robot-assisted PCI over long distances?

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 - CorPath GRX robotic system

Recent studies have shown robotic PCI to be a feasible way to treat coronary artery disease. But at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference Oct. 30, Ryan D. Madder, MD, took the conversation a step further: Will it eventually be possible to perform “tele-stenting” over long distances?

In other words, could an operator in Florida, using robotic technology, perform PCI on a patient in Montana? How about Germany?

Madder served as the lead investigator of the REMOTE-PCI study, which demonstrated operators can perform PCI while in a different room from the patient. In this case, it was simply an adjacent room in a cath lab because the current robotic technology requires a hardwire connection between the system itself and the interventional cockpit that controls the system.

Madder’s research team from Spectrum Health in Grand Rapids, Michigan, reported 19 of 22 lesions (86.4 percent) were successfully treated via advancement and retraction of guidewires, balloons and stents by the robotic device. Nineteen of 20 patients experienced residual stenosis of less than 30 percent and were discharged from the hospital without repeat revascularization or death—a 95 percent procedural success rate.

To perform these operations truly remotely, not just a room away, the bedside robotic arm would need to be connected to the cockpit control center through a web-based network. Madder pointed to a case from 2001 called “The Lindbergh Operation” in which an operator in New York completed a robotic laparoscopic cholecystectomy on a patient in Strasbourg, France.

“I would argue with all the advances that have been made in internet connectivity, if they can do this back then, I think we can probably figure out how to do tele-stenting now,” said Madder, who has received research support from Corindus Vascular Robotics, the manufacturer of the system.

Of course, there are additional hurdles to address.

Ehtisham Mahmud, MD, another principle investigator of the technology who has received research funding from Corindus, said regulatory issues would be a factor.

“You’ve got to figure out if the physician is doing it robotically, are they going to be licensed where they operate the robot or where the patient is?” said Mahmud, with the University of California, San Diego School of Medicine.

Is robotic PCI even necessary?

PCI was first performed 40 years ago and has become a widespread procedure for interventional cardiologists. With so many skilled human operators, should hospitals spend the roughly $650,000 for the second-generation CorPath GRX, plus the additional $650 to 750 for each single-use accessory cartridge?

Mahmud believes the biggest beneficiaries of the technology could be interventionalists themselves. By taking them away from patients’ bedside, the exposure to radiation could be cut by 95 to 97 percent, previous studies have shown. And common orthopedic injuries among interventional cardiologists could be reduced because physicians won’t spend as much time hunched over patients wearing heavy lead aprons, Mahmud said.

What would remote PCI look like?

Both Madder and Mahmud agree that tele-stenting wouldn’t relieve the need for a physician to be in the room during these procedures. Manual access to the patient would still be required in case there are complications.

However, Mahmud can envision a scenario in which more experienced operators are available remotely to help less-experienced colleagues during complex cases.

“You could essentially take a large health system … say a health system with seven, eight, 10 hospitals geographically disparate from one another … and you would not have to have the same level at high expertise at all of them,” he said. “You could potentially have less experienced operators tableside and maybe one or two highly experienced robotic operators that are sitting centrally and that can assist multiple physicians and multiple cath labs within their single network without having to physically go to different locations.”

Next steps

The discussion around remote PCI is speculative for now. Within the walls of their own hospitals, Mahmud and others are evaluating whether the robotic systems are improving.

Mahmud’s research group reported a 97.5 percent clinical success rate and a 90 percent technical success rate among 40 patients in the first in-human report of Corindus’ second-generation system. In September, they enrolled the first of up to 1,000 patients across 25 sites for a larger-scale study of the CorPath GRX system.

The biggest difference between the CorPath GRX and the first-generation CorPath 200 system, Mahmud said, is the newer device enables the operator to control the guide catheter.

“You could only control the guidewire and the stent or balloon delivery systems” with the first-generation device, Mahmud said. “There were two control knobs and you could only do two things and now there are three control knobs and you can actually control the guide catheter. If you need to either engage the coronary artery or provide more guide catheter support to advance a stent or balloon to a more tortuous lesion, you can do that robotically.”

Mahmud said the learning curve for new users of the technology is about three to five cases for simple lesions and 20 to 25 cases for complex lesions. And there are still more device-specific improvements to be made.

“From a robotic platform standpoint, the next things that need to be solved is currently it’s a rapid exchange system and you can only advance and retract one guidewire or balloon or stent at a time,” Mahmud said. “If we think about more complex lesions, they sometimes require over-the-wire systems for chronic total occlusions and atherectomy and also for bifurcation lesions. We want the ability to control multiple guidewires and delivery systems.”