Procedural Automation in PCI

How to advance interventional capabilities

A simple fact about the work that interventionalists do is that the more procedures you perform, the better you will be at performing them. There is an inverse relationship between PCI operator volume and in-hospital mortality rates that persists in risk-adjusted analyses. Patient mortality is 28% higher for low-volume operators performing PCI in low-volume hospitals than for high-volume operators performing PCI in high-volume hospitals (OR: 1.28; 95% CI: 1.21 to 1.35).⁴

In the U.S., interventionalists tend to have relatively low annual procedure volumes. The average interventionalist only performs 50 PCIs per year. The number of interventionalists that perform fewer than 50 PCIs per year is quite high, while the number of interventionalists with a high annual PCI volume is fairly low. Only one third of all interventionalists in the U.S. perform more than 150 PCIs per year.⁴ And the truth is that only these interventionalists really have the opportunity to apply their skills regularly and to continuously improve.

Not enough experts

Many provider organizations only employ a small number of expert interventionalists with the skills to perform complex cases reliably. Limited availability of expertise can make scheduling these cases very difficult and may result in long waiting times for patients. Other providers may decide to defer complex cases to more specialized centers right away. To these providers, these cases represent lost revenue sources, and lost opportunities.

The problem of limited experience and expertise isn’t going away any time soon, and in fact may well be worsening. Almost a quarter of the interventional work force in the U.S. is over the age of 61 and close to retirement.⁵ “More and more are reaching an age where slow-down is inevitable,” concludes MedAxiom’s 2017 compensation & production survey. This will almost certainly lead to a shortage of experienced interventionalists in the near future.

Procedural automation

The solution, clearly, is to find a way of providing all interventionalists with high-volume skills. And this is possible thanks to automated robotic movements for interventional procedures. CorPath GRX supplies the operator with a set of automated movements for guidewire navigation and lesion crossing. These movements replicate the manual techniques of highly skilled interventionalists and have the effect of not only advancing the skills of interventionalists, but making them faster by eliminating the practice of trial and error in manual PCI.

It is not a question of replacing the human element – physicians will always be needed to oversee and control these procedures. Rather, what they are able to humanly accomplish is enhanced.

Wiring complex lesions successfully with robotics

CorPath GRX provides the operator with a set of automated robotic movements for guidewire navigation and lesion crossing. These movements replicate the manual techniques of highly skilled interventionalists and may help to eliminate the practice of trial and error in wiring lesions. This can help to reduce procedure length, radiation exposure, and contrast agent dose, as well as the number of guidewires that need to be used.

Commitment to a “robotics first” mindset

“One of the keys to developing a successful R-PCI program is understanding that all cases are suitable for robotic intervention,”⁷ says Ryan D. Madder, MD, Section Chief of Interventional Cardiology and Medical Director Cardiac Cath Lab at Spectrum Health in Michigan. Approaching every case as a potential robotic case can help you receive the maximum benefit for both, patients and caregivers.

You can have the best of both worlds

A huge added value of R-PCI is that it is not an all-or-nothing proposition – it is possible to blend the best of manual and robotic PCI in one hybrid approach. William L. Lombardi, MD, from the University of Washington Medical Center, USA, approaches highly complex cases such as chronic total occlusion PCIs – extremely lengthy procedures with a high radiation dose – with just such a hybrid mindset. He performs atherectomies in a manual fashion first and integrates the robot for added precision and reduced radiation. With this hybrid approach, he says: “I don’t think there is much limitation to what this technology R-PCI can do. I would never go back to manual PCI. What makes these hybrid procedures possible is that CorPath GRX allows you to switch to manual in a few seconds only.”⁸

”Hands-on” is not necessarily better

An objection that is sometimes raised to R-PCI is that interventionalists need tactile feedback. They need to feel what they’re doing in their fingertips. Which is understandable, since it is what they have always done. But in truth, they don’t need it at all. Consider:

1. Comfortably sitting directly in front of a high-definition widescreen monitor in the control room or a shielded workstation allows you to follow and control the movements of the wire and device very carefully. This set-up actually gives you a much better view of what is going on that you would get standing hunched over the bedside table. R-PCI users report that they quickly got used to performing their procedures with visual instead of tactile feedback. In fact, they consider the visual feedback to be a great advantage in their work with fellows or cooperating with other physicians in challenging cases.
2. Due to the precision and automation techniques of the system, you need less trial and error compared to manual PCI. Using the four automated movements described above, virtually every resistance you encounter can quickly be overcome with an appropriate redirection of the wire by the robotic system, whereas in a manual procedure, you might have to try multiple twists and turns – or even another guidewire.
3. Performing the repetitive tasks associated with wiring lesions with robotic assistance allows users to save their energy for more critical parts of the procedure, such as positioning stents.
4. In addition, the system is equipped with a protective mechanism that limits the drive force. You will receive a “pushability” notification if the robotic system has reached its maximum force limit to avoid coronary perforations.

What is the pushability notification

The pushability icon can be seen on either the guidewire or device sections of the control screen. It indicates that the CorPath GRX System has reached its maximum drive force limit on either the device or guidewire.

How long does it take to adopt R-PCI?

The PRECISE multi-center study demonstrates the safety and feasibility of R-PCI. It concludes: “After performing three cases, interventionalists were able to complete robotic-enhanced PCI faster, with reduced radiation, and without compromising safety. The steep learning curve highlights the easy adoption of remote-control robotic technology for PCI.”⁸

Is R-PCI worth the investment? The answer to that is another question. How can it not be? The world population is growing, and it is aging. So it is very likely that the need for PCI will grow in line with the ageing population. At the same time, however, as noted above, there are fewer and fewer interventionalists available. This means that going forward, your service line will either be offering an in-demand service with adequate waiting times, or patients will be ignoring you in favor of providers that do.

R-PCI can solve that problem for you. Previously, you might have only been able to assign challenging cases to individual experts in your service line, resulting in long waiting times, or you might even have been forced to send them on to more specialized institutions. Both can negatively impact the reputation of your service line and your hospital. R-PCI will allow you to offer your patients the procedures they need, when they need them. It can help you to reduce waiting times, allowing you to take on even more complex cases, possibly allowing for higher reimbursement and revenues.

Savings of $53 per R-PCI for contrast media

R-PCI is associated with approximately 20% less radiation exposure to patients.¹³ With both referrers and patients increasingly focused on side effects associated with care delivery, these numbers can give your institution the competitive edge to stand out among other providers in your area.

Chances are good that thanks to the advanced skill set of your operators, your program and patient volumes will grow. This is true also because many PCI patients may be insured by companies that are more confident in the service you provide than in rival organizations that still do PCI manually.

On the cost side, we’ve already pointed out that procedural automation reduces trial & error. Bluntly put, less experienced interventionalists might get it right on the first try when trying to cross lesions with robotic assistance, which can result in cost savings from fewer guidewires. Let’s assume that your institution requires two guidewires per PCI on average. If lesions were crossed with the first guidewire right away, this would result in more than 50% savings for guidewires and a reduction in total procedure time.

Furthermore, automated movements can reduce fluoroscopy time and the need for contrast media. Beyond direct savings for contrast media of 35%,10,11,12 a reduction in contrast media will likely be associated with less contrast-induced acute kidney injury (CI-AKI), which may help to lower associated costs.

Conclusion

Procedural automation is here to stay, and the CorPath platform is positioning itself to be a leader in R-PCI for many years to come. CorPath GRX has been used in approximately 10,000 interventions in over 15 countries around the world.¹⁴ To further support career longevity for physicians and high-level, standardized care, the next evolution of this technology will incorporate a higher degree of automation – giving the robotic platform freedom to make procedural movements that are “learned” from past procedures, says Wayne Markowitz, Executive VP of the Corindus business for Siemens Healthineers.

“We’re very excited to continue to develop procedural automation for cardiovascular intervention,” said Markowitz. “Automation will allow us to standardize patient outcomes and help physicians focus their energy on case strategy rather than the tedious task of manual device manipulation. While portions of the case can be automated, we believe a physician should always monitor progression of the case live and intervene when necessary to ensure the highest levels of safety and patient care.”

As it stands today, the benefits of CorPath GRX are extremely hard to overlook. It ensures that even your low-volume operators have high-volume skills, in effect making your institution one that offers only expert-level PCI. That is by definition good news for your interventionalists, good news for your patients, and good news for your organization.