Clinical Trials

Long-Distance PCI With Robotics: Telestenting’s First Steps, Tested in REMOTE-PCI

Cath Lab Digest talks with Ryan D. Madder, MD, FACC, and Mike Oostdyk, Lead Technologist, Kresge Cardiovascular Catheterization Laboratory, Frederik Meijer Heart & Vascular Institute, Spectrum Health, Grand Rapids, Michigan.

Cath Lab Digest talks with Ryan D. Madder, MD, FACC, and Mike Oostdyk, Lead Technologist, Kresge Cardiovascular Catheterization Laboratory, Frederik Meijer Heart & Vascular Institute, Spectrum Health, Grand Rapids, Michigan.

How long have you been using the Corindus CorPath robotic PCI system?

We obtained our first system in March 2014 and a second system some time after that, so we actually have two robotic labs in our hospital. 

At first, were you using robotics only for very specific types of cases?

At first, our robotics program started with PCI cases that were more straightforward. Within the first few months of use, we progressed from doing straightforward cases to doing more complex interventions with the robotic system. There are other programs around the country that have also become experienced at doing complex PCI cases robotically. One good example is Ehtisham Mahmud’s program at the University of California, San Diego. In fact, he has been formally studying complex robotic PCI. I think we are going to see, over the next several years, literature coming out that supports the role of robotics in more complex procedures.

How is the robotic system set up in the cath lab?

The physician is no longer standing adjacent to the patient; the physician is in a cockpit. The cockpit is positioned a few feet away from the patient and the operator performs the PCI procedure while sitting in a chair within the confines of the cockpit. For the operator, the benefit of doing a robotic PCI is that it reduces your radiation exposure by >95%. That is what the studies have shown. In our center, we have data showing that operator radiation exposure with robotic PCI is reduced by about 99% compared to manual PCI.1 These are quite dramatic reductions in radiation exposure for the operator. We have shown in other data from our center that robotic PCI procedures do not increase the amount of radiation used during the case, so the patient is not getting irradiated any more when robotics are used. We also have data we are working on that has not yet been published showing that robotic PCI does not increase technologist exposure.

The physicians aren’t wearing lead. That must be good for the body as well.

Yes, I believe robotic PCI is likely to cut down on orthopedic risks. Whereas it is easy to quantify the radiation reduction associated with robotic procedures, it’s much more difficult to quantify the orthopedic benefits of not wearing lead. I think over time we are going to see systems like the robotic system reducing orthopedic injuries, although that has not been shown yet. 

How did the REMOTE-PCI study2 come about?

If you can perform a PCI procedure sitting in a cockpit a few feet from the patient, then there is really no reason you couldn’t increase that distance using modern technology. The thing that limits the distance right now are that the two components of the robotic system — the bedside arm, which is on the table with the patient, and the cockpit, are attached by a series of cables. If we were to hook these two components up via a WiFi network or something similar, then the distance between operator and patient suddenly could become much greater. 

I believe there is a need for us to explore whether “telestenting” procedures could potentially play a role in current practice. Two things lead us in this direction. First, geographic barriers still exist that impact ST-elevation myocardial infarction (STEMI) care in the U.S. Like other large referral centers, Spectrum Health has a large STEMI network with multiple referring hospitals. Typically, helicopters can transport STEMI patients from our referring hospitals to Spectrum Health within 20 or 30 minutes. However, when the weather is severe, particularly in the winter months in Michigan, helicopters are often unable to fly and the 20-minute flight time turns into a 3-hour ambulance ride. That is obviously a problem for STEMI patients, because these long transport times can greatly delay the time to reperfusion, especially if lytics administered at the outlying facility were unsuccessful. If there was some way to get that artery opened remotely, then it might be something that is beneficial. Second, I think there are populations in third-world countries that do not have access to an interventional cardiologist, and telestenting could be explored in those areas. This may be true even in some rural regions of the United States, as demonstrated in a 2012 paper in Circulation that looked at access to PCI.3 According to prior data, about 80% of the U.S. population lives within a 60-minute drive to a PCI hospital. But access to PCI differs based on where you are located in the U.S. On the East or West Coast, in states like New York, California, and New Jersey, a majority of the population, greater than 90%, is within a 60-minute drive to a PCI hospital. But in more rural states, such as Alaska, Wyoming, and West Virginia, less than 50% of the population of those states is within a 60-minute drive to a PCI hospital. Plus, many of those same states, throughout the course of the year, have different weather patterns, making that 60-minute drive even longer when the weather is bad. Robotic telestenting may be something that we can explore as a potential solution. 

What about the more technical aspects of performing robotic PCI in a remote fashion?

From the operator’s perspective, the way that you actually sit in the cockpit and drive the robotic controls is the same when performed remotely. The thing that differed in our study was the communication. We removed the cockpit from the room the patient was in and put it in an isolated, separate room. There was no direct line of audio or visual contact with the patient or staff members. Our solution to communicate was through the use of telecommunications devices that provided real-time audio and video connectivity with the cath lab. The telecommunications consoles had high-definition cameras and we had one in the room where the cockpit was with the physician, and another in the cath lab with the patient and staff members. The physician in the cockpit had control of the camera that was in the cath lab and was free to look around the cath lab.The physician could zoom in on the technologist’s hands and monitor them doing the exchanges, and could zoom in on the stent or balloon box, when they were opened, to make sure it was the size that was requested. Those same visual cues that we use during manual PCI, can still be done with the use of these telecommunications devices. We also had a monitor on each of these telecommunications devices, so not only could the physician see what was going on in the cath lab, but a camera was focused on the physician as well, so that the patient, the technologist, and the nurse could all see the physician on the monitor. I think this approach added a level of comfort for both the patients and the physicians and staff members that the physician was virtually present in the cath lab.

The REMOTE-PCI study was all done within Spectrum Health, because of the current limitations on the bedside arm and cockpit being connected via a series of cables. We simply wheeled the cockpit into a separate cath lab and shut the door. As of yet, there is not a robotic system where the components are hooked up wirelessly, although we have obtained a grant that will allow us to develop, in collaboration with Corindus, a system that is capable of powering the components over longer distances. In the REMOTE-PCI study, the distance between the operator and patient was 55 feet. If you think about it, every manual PCI ever performed has been done with the physician standing adjacent to the patient. With traditional robotic PCI, the physician usually performs the PCI at a distance of 5-7 feet from the patient. By comparison, 55 feet seems like a long distance over which to perform a PCI.

This initial step was also a good way to start to put policies and protocols in place.

We had a safety net for this study. Per our protocol, we had a second interventional cardiologist in the cath lab with the patient. This physician didn’t do anything for the patient, but was there in the event that some complication happened. Thankfully, no complications did happen, but that was our protocol to keep patients safe during this study.

Tell us about the patients that were included in REMOTE-PCI.

Nineteen of the 20 patients were acute coronary syndrome patients. Six were acute myocardial infarction patients. They all came to our cath lab for catheterization and possible PCI. To meet criteria to be in the study, the patient had to have a lesion that could be approached robotically. We achieved technical success in 19 out of 22 lesions, so we were able to fix 86% of lesions robotically in a remote fashion. In the 3 cases that were not technically successful, 2 of those were because we could not deliver the stent. We were able to robotically do angioplasty, but we could not get the stent to deliver. In both of those cases, when we converted them to manual procedures, they were challenging, even from a manual standpoint, to deliver the stent. In the third case that was not technically successful, we were able to get a wire across the lesion, but the lesion was so tight and calcified we couldn’t even pass an angioplasty balloon. We couldn’t do this case robotically and we couldn’t do it even when it was converted to a manual procedure. We took that patient off the table and brought them back several weeks later for rotational atherectomy and stenting, which went successfully. In the study, the overall procedural success, where we had a good stent result without any complications, was achieved in 19 out of the 20 patients.

Can you address radiation exposure in the study?

For the patient, we saw no increase in radiation exposure compared to a control group of patients that underwent traditional robotic PCI. With the cockpit being in a separate location for these remote cases, there was no radiation for the operator.

How did you interact with the “safety” interventionalist at the bedside?

There was not a lot of technical talk, since they played a minimal role in the procedure, other than just serving as a safety net. They were scrubbed in, in the sense that they had a sterile gown and gloves on, but they stayed back from the table and let the technologist do what the technologist normally does in these robotic procedures. 

What if a case was converted to a manual PCI?

For the three cases we converted to manual, the operator that was doing the robotic PCI came back into the room and scrubbed in, and relieved the safety net person. 

You had 3 cases where conversion occurred. How common is the move to a manual procedure in robotic PCI?

The PRECISE study, which was one of the first robotic studies published, showed a technical success rate of 98.8%, meaning operators had to convert to a manual procedure in only 1.2% of cases.4 Our technical success in the REMOTE-PCI study was less likely, because the lesions were more complex and the procedures were being done remotely. The technical success rate with robotics in general is very high. 

Who would you envision as the safety net with the patient if the robotic procedure became geographically remote, from one facility to another?

This is a very important hurdle and is one of the potential limitations of remote procedures. You will need a second individual with the patient who is capable of obtaining arterial access, placing a guide catheter, and managing any complications that arise. Who that individual should be, whether that is a physician’s assistant (PA) or another type of physician, we have not yet figured out. I think the most obvious choice would be an invasive non-interventional cardiologist. There are a lot of cath labs around the country doing diagnostic catheterizations, but if they find a lesion, they don’t have an interventional cardiologist and they end up transferring the patient to a PCI center. Invasive, non-interventional cardiologists are capable of putting in a sheath and a guide catheter, and managing complications that arise. Facilities like these would be the ideal places to start potentially remote procedures. It brings up a lot of interesting opportunities where such facilities would not need to transfer their PCI patients if telestenting develops further.

You now have a grant to work on developing wireless technology?

Yes, we received a grant to develop a robotic system capable of performing telestenting. I am collaborating with a robotics PhD who has experience in telerobotics. 

Do you have any recommendations for labs interested in getting involved with robotics?

Over the past 3 years, having the robotics system has reinvigorated radiation safety in our lab. We have done a number of things to look at radiation safety in our lab, which I think arose out of the robotics system getting up and running. For other institutions considering robotics, one thing they could consider is using this as a tool to reinvigorate radiation safety at their institution. We have actually gone on to do a number of radiation safety studies. As a result of our robotics program, we have developed a radiation safety committee, specifically designed to improve radiation safety in our lab, not just from the physician standpoint, but also taking measures to lower radiation levels for our nurse circulators and our technologists, and reduce radiation for our patients. I am hopeful it is something that will gain traction here and make our lab safer for everybody.

Any final thoughts?

We are very fortunate at Spectrum Health that our cath lab nurses and technologists are extremely progressive. They invite challenges and they like new technology. I think there is a sense of pride at our cath lab that we try to improve patient care, radiation safety, and overall procedural safety. We have the right spirit here to use a lot of these new technologies help better cardiac care. 

The final thing I would emphasize is that the REMOTE-PCI study is just one very small initial step into the idea of telestenting. It is a small pilot study. There is much work that has to be done yet and plenty of obstacles that must be overcome. This is one very early step in this idea.

References

  1. Madder RD, VanOosterhout S, Mulder A, Elmore M, Campbell J, Borgman A, et al. Impact of robotics and a suspended lead suit on physician radiation exposure during percutaneous coronary intervention. Cardiovasc Revasc Med. 2016 Dec 16. pii: S1553-8389(16)30347-5. doi: 10.1016/j.carrev.2016.12.011. [Epub ahead of print]
  2. Madder RD, VanOosterhout SM, Jacoby ME, Collins JS, Borgman AS, Mulder AN, et al. Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the feasibility of telestenting (the REMOTE-PCI study). EuroIntervention. 2017 Jan 20; 12(13): 1569-1576. doi: 10.4244/EIJ-D-16-00363.
  3. Concannon TW, Nelson J, Goetz J, Griffith JL. A percutaneous coronary intervention lab in every hospital? Circ Cardiovasc Qual Outcomes. 2012 Jan; 5(1): 14-20. doi: 10.1161/CIRCOUTCOMES.111.963868.
  4. Weisz G, Metzger DC, Caputo RP, Delgado JA, Marshall JJ, Vetrovec GW, et al. Safety and feasibility of robotic percutaneous coronary intervention: PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study. J Am Coll Cardiol. 2013 Apr 16; 61(15): 1596-1600. doi: 10.1016/j.jacc.2012.12.045.

Disclosure: Dr. Ryan Madder reports research support and serving on the advisory board for Corindus Vascular Robotics. 

Dr. Ryan Madder can be contacted at ryan.madder@spectrumhealth.org.

 

CLD Talks With Mike Oostdyk, Lead Technologist

Can you share some of your experience in the lab?

I have been in the cath lab now for 6 years, as of October. Our facility deals with a lot of shock patients. We probably have some devices that not every facility around the nation has. We do extracorporeal membrane oxygenation (ECMO), Impella (Abiomed), and a lot of atherectomy. We are an advanced facility. This is a wonderful place as far as learning and having the ability to do things that perhaps other facilities and techs don’t have the opportunity to do. 

How long have you been involved with robotic percutaneous coronary intervention (PCI)? 

Ever since it began at Spectrum Health; we are now 3 years into the program. The Corindus CorPath system has been in place since March 2014. Along with a Corindus representative being here to support the cases, especially early on, we had a few staff members travel to Boston for additional training. They became our super users, and we have been able to use them as reference points.

What are the different roles for staff when you are doing a robotic PCI? How does it differ from a traditional PCI?

We still require at least one technologist and one nurse. We typically run with a minimum of three staff members, in addition to the physician. Set up of the equipment is primarily done by the technologist. The nurse or the secondary tech that is in the room will also pull the non-sterile console out of the area where it sits. They will bring that piece of equipment out for the physician and make sure that the robotic arm that is attached parallel to the patient is positioned appropriately. The scrub tech will drape the robotic arm and set up the console in a sterile manner. It is probably about a 5-minute prep procedure. It is not a significant amount of time as far as prepping goes and it is not difficult.

Does it matter if access is radial or femoral?

No, it really doesn’t matter. We are a primarily radial facility. We do a lot of robotic procedures radially and they can be done femorally. The only thing that changes from a femoral to radial approach is the positioning of the robotic arm. It’s a matter of a few extra seconds making sure that robotic arm is set in the appropriate position. 

Are the technologists involved with loading equipment into the system?

Absolutely. It is a primary focus. Not every tech feels comfortable with it, and that’s ok. It is definitely a little more challenging. You must be technically sound and understand the general concept of what’s going on, and make sure not to either pull the wires back or advance the wires. This aspect does present a little more of a challenge, which I appreciate. I also appreciate the fact that the physician trusts me enough to step away from the table and I am going to make sure that what I am doing is appropriate.

Do you have any concerns regarding the robotic PCI procedure?

Not really. It will be interesting to see robotics develop over the next few years, as well as the next-generation CorPath system, which I believe our facility will be receiving shortly. Our facility uses a lot of Zero-Gravity lead (Biotronik), which I know other facilities nationwide may not have. If you are in a facility where they don’t have Zero-Gravity, the tech needs to be mindful of using shielding appropriately. I don’t feel that I am receiving an increased dose of radiation during the procedure, per se. It is more a matter of making sure of using your shielding appropriately, whether it is Zero-Gravity or the shields that are provided by the facility. 

Mike Oostdyk can be contacted at michael.oostdyk@spectrumhealth.org