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 system, by having all the intravascular devices mounted into the system, it’s like working with three or four hands,” he says. “It’s much more stable, accurate and precise, and the operators can use it while sitting comfortably and not hurting themselves.”

There are encouraging data from the training standpoint as well, says James A. Goldstein, MD, who is director of research and education, department of cardiology, Beaumont Health System, Royal Oak, Mich., and, like Klein, a founding member of the Multispecialty Occupational Health Group.

“The early studies thus far suggest that with a little bit of practice and experience, interventional cardiologists can become quite adept at maneuvering the robot and performing even anatomically complex procedures,” Goldstein says.

Data from the PRECISE trial, in fact, indicated that the biggest step in proficiency of the procedure was between case number three and four, and that after approximately 20 cases, operators could move from simple and intermediate lesions to complex PCI procedures, Weisz says.

In addition, “Teaching the staff was relatively easy,” he says. “They already know the coronary artery, the anatomy and the devices. They don’t have to learn the characteristics of new devices since we are using off-the-shelf devices. So whatever your workhorse guidewire, balloon and stent are, you can adjust them to your experience and what you think is best for the patient.”

The cost conundrum

Although interventionalists may welcome a system that can provide this number of potential benefits, the chief barrier that continues to impede widespread implementation is cost.

“The cost involves the console, which is in the six figures [about $400,000], plus each case has its own additional disposable cost on top of the disposables that are used in the lab now,” Klein says.

This additional disposable cost involves a single-use cassette in which the wire, balloon and stent are loaded. Inside the cassette, multiple wheels advance, retract and rotate the devices inside the blood vessel. These cassettes must be used with each robotic PCI procedure; however, Medicare currently does not reimburse for the expense.

“I don’t think [the cassettes] will ever be reimbursed,” Klein says. “Third-party payers are trying not to pay for what we are doing now, let alone for additional costs. I don’t see it happening. They would demand proof of better efficacy and more safety, and that’s not very likely, at least not right away.

“You’re talking about a procedure that is keeping a number of hospitals afloat,” he continues. “So administrators are watching the profit margin of these procedures and the idea that you are going to cut into the profit margin for disposables and you need a large capital outlay would be a very tough sell for most hospitals in the country right now.”

However, Weisz says that with the increased precision of the robotic system, there is the potential to save money on stents.

“So this offsets a little of the cost of the cassette,” he says. “If we take [into account] that you keep the operator more calm, less sore and tired, it improves his or her decision-making. That is, of course, hard to measure in an economical way, but it definitely adds to the standardization, quality and precision of PCI procedures.” 

Yet, using fewer stents may not necessarily provide the cost advantage needed to overcome the expenditure of the cassette, according to Klein. 

“You get to upcharge for every stent used, so to an administrator the idea that I’m going to cut down on the number of stents cuts both ways,” he says. “It’s a very tricky situation.”

As the transition to a value-based payment model takes place, Klein anticipates that creating a business model for a high-cost capital expenditure, like robotic PCI, will still be challenging in the current reimbursement climate. “But if [return on investment] is viewed in full economic terms, personnel costs are potentially a strength. If new techniques like this are not sustainable economically then the future of medicine [would be] bleak indeed,” he notes.

Striking a balance

For Goldstein, the critical issue a healthcare system should consider in deciding on whether to implement a robotic system in the cath lab is the protection of the operator relative to system costs. 

“In an analogous sense, one might ask what is the cost/benefit ratio of using airbags in automobiles—what is the value placed on the safety and health of the driver and how does one establish a dollar value on that ‘priceless’ protection?” Goldstein asks. “There is now well-established clinical data to support the increasing concern over workplace hazards for both physicians and allied health professionals working in the cath lab, based on convincing data regarding orthopedic complications associated with wearing only partly protective heavy leaded aprons necessary to minimize radiation exposure. Those working in the cath lab are also at risk for developing cataracts, and there is increasing concern they may develop cancers associated with radiation exposure.”

Acknowledging these risks and recognizing that physicians and staff are important assets for any healthcare system are the keys to overcoming the cost issue, Mahmud says.

“If you can prolong people’s careers and make it so that everyday they are a little more rested, a little less exposed and on their feet… you will probably have better utilization of resources and better outcomes for patients,” he says. Mahmud speculates that the robotic system could also potentially keep physicians from prematurely retiring, thus reducing the expense associated with training new people.

“In addition to thinking about covering hard costs, we need to think about soft costs and staff experience and their exposure to radiation,” Murphy adds. “So I think that [the Centers for Medicare & Medicaid Services] is going to have to lead the way, because the commercial payers tend to follow their lead. So if they begin to recognize the quality of life issues… they really should enhance the reimbursement for these kinds of devices.”

The future of interventional cardiology?

In the years ahead, although the cost issue will still loom large, the future prospects for robotic PCI in the cath lab remain bright, according to experts interviewed.

“With further evolution and improvement, and demonstration of comparable if not superior clinical results, [robotic-assisted PCI] will become the standard in the cath lab because the procedure is safer for the operators and potentially for the rest of the staff,” Mahmud says. “For health systems, the key is going to be whether it is worth the incremental cost per case, and that is probably going to be a very limiting step.” 

Klein suspects that for robotic PCI systems to become widespread, it will require a well-known figure in the field with institutional backing who is willing to put his or her reputation and livelihood on the line for this technology.

“If you then had data that referrals increased beyond the usual base… If someone could provide testimonials like that, now you are talking,” he says. “In the current environment, I just find it hard to believe that is going to happen.”

While the future prevalence of robotic PCI in clinical practice is far from certain, what is clear is that new data are needed to help answer key questions about the technology.

“My vision is in a couple of years, we will see a much wider spread use of the robotic system,” Weisz says. “Right now, it’s used only for coronary PCI, but I honestly believe in the future it will be expanded to peripheral, intracranial and structural heart interventions.”

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Survey Says: Orthopedic Complications Prevalent Among Interventionalists

In April, the Society for Cardiovascular Angiography and Interventions (SCAI) published a survey that examined the occurrence of occupational health problems among interventional cardiologists, focusing on issues related to orthopedics, such as the spine, hips, knees and ankles, and radiation, like cataracts and cancers. The survey was sponsored by Corindus.

The results appeared in Catheterization and Cardiovascular Interventions (2015;doi:10.1002/ccd.25927).

Overall, 314 SCAI members responded to the survey, and of them, nearly half (49.4%) indicated that they had experienced at least one work-related orthopedic complication. Specifically, 24.7 percent of responders had cervical spine disease, 34.4 percent had lumbar spine problems and 19.6 percent had hip, knee or ankle joint problems.

“Orthopedic illness is common in interventional cardiologists and is increasing in frequency. This is resulting in serious injury,” says Lloyd W. Klein, MD, lead author of the paper from Rush Medical College in Chicago. “Although it seems that operators aren’t missing work, they are retiring early. The reasons why are speculative, but we guess it relates to the facts that the remedies are costly, fear of loss of income and job, and desire for early retirement.”

In addition, 6.9 percent of operators surveyed had to limit their caseload as a result of radiation exposure and 9.3 percent had a health-related period of absence.

According to the authors of the paper, since the last SCAI survey on occupational hazards among interventionalists was conducted in 2004, there have been positive changes to the working conditions in the cath lab, including advancements in imaging equipment and innovations in shielding and lab design that have led to commercially available improvements in radiation safety; however, Klein says that except for measuring X-ray exposure, which is mandated by the federal government, few operators are using the enhancements.

“This is demonstrated in the study results,” he says. “The reasons likely include both cost and intrusiveness on operator movement.”