The 2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic: An International Collaboration on Standards of Care and Best Practices for the Remote Clinic

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EP LAB DIGEST. 2023;23(7):1,8-10.

Brad Knight: Hi, I am Brad Knight, editor-in-chief of EP Lab Digest, and I am joined here today by Dr Satish Raj. We are going to talk about remote monitoring and the new document that was recently published on remote monitoring for devices.

Satish Raj: Thanks for having me here.

Bradley Knight, MD: Can you start by telling me a little about what motivated you and your team to come up with a document on remote monitoring?

Satish Raj, MD, MS: Up until now, there had been a lot of published documents on the science of remote monitoring, how it could help patient care, and how it has become an important part of our device management program. The challenge is that as remote monitoring has become more popular and there is more uptake, it has become less clear how to achieve this effectively in the clinic. There are a lot of patients in clinic, and clinics are still doing all the things they were doing before. On top of that, they are now dealing with remote monitoring. So, issues have presented such as how long to spend with patients, what staffing needs are, what exactly the workflow is, or should be, for remote monitoring, and what types of communications are required with the patient, other providers, and with the electronic medical record (EMR). It became the Wild West. Every clinic was struggling and trying to do it their own way. Therefore, we wanted to partner with other organizations around the world to provide some guidance both on how to deal with the struggles today and where the field is going. This was a partner document between the Heart Rhythm Society, European Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society. What became clear is that this is not only an American or a North American problem—this is a worldwide struggle for everyone.

Knight: There is a lot of data that this is good for patients and improves outcomes, but the implementation of it can be a challenge. Maybe we can go through it from a patient perspective, such as when you see a patient in clinic before they have had a device implantation. Discuss the role of remote monitoring preop.

Raj: This is a critical recommendation. We think the discussion should be done on the front end, and there are several reasons for that. The first is that on the day of implant, you as the provider may be doing 5 or 6 implants that day. However, for the patient, this is a big deal, and their focus is going to be “Someone is going to make an incision in me, and I am having this medical procedure.” They are not going to remember anything else you discuss. Therefore, discussions in advance will allow them to solidify the teaching. But more importantly, remote monitoring is not only remote monitoring—there are multiple technologies that are available. I think we are evolving to more of a continuous connectivity model and smartphone app-based models. But in none of our clinics are 100% our patients on that platform. There are different technologies available, and patients have different technical abilities and needs, so it may affect the choice of which device you choose to put in the patient.

Knight: I have that as a preop conversation.

Raj: Absolutely.

Knight: Immediately postop, how do you operationally make this happen and how does it affect whether they do same-day discharge?

Raj: This is a great question. For our clinic in Calgary, this is something that we are going to have to work on doing better. Because right now we are not instituting remote monitoring until that first follow-up visit. But the statement that came out makes it very clear that we think this is important from day one, and ideally, remote monitoring should be initiated at the time of implant.

Knight: We try to do that at Northwestern and take advantage of the fact that we have an industry representative there who can meet with the patient and their family. But again, if the patient is thinking about 100 things preop, they are also thinking about 100 things postop, so it must be reinforced at follow-up.

Raj: It must be reinforced not once but during every visit. So, one of the principles that came out of the document was that the whole issue of patient engagement and patient consent isn’t a one-off. It is not a discussion you have in the preop clinic and then “we have had the discussion”. The truth is that the needs of the patient evolve as it pertains to the device and remote monitoring. Sometimes it is a matter of what they remember from the prior visit and sometimes the needs have actually changed. Therefore, these are ongoing discussions and should be reinforced during every follow-up visit with the patient.

Knight: When a patient follows up, whether it is remotely or in clinic, you need resources to do that. You need a team of people to do that. Can you talk a little about the challenges of staffing a device clinic and the role of outsourcing this?

Raj: There are several things you touched on there that we address in the document. Let me first talk about the third-party issue. The models vary a lot across the world. Certainly, in the United States (probably more than a lot of other jurisdictions), the third-party companies have been a boon to several clinics. There is a tradeoff. Obviously, the user resources cost money. On the other hand, with our current billing system, in some cases they can help you bill more efficiently and so there may be a net financial gain. So, it is certainly something that can be looked at, especially if you have trouble staffing your own clinics. Post COVID, one of the challenges I think a lot of clinics have had is that nurses and trained technical staff have disappeared. There is less of them now, or it seems like there is less of them now, than there used to be, so third-party resources could be helpful.

Knight: Yes, I think every clinic is different. Some clinics really would benefit from outsourcing it and others would not. There is a business model that must be considered, but then there is also the issue of patients need this and if you do not have enough staffing, sometimes it is the only option.

Raj: But there is a more complex discussion. Those of us who actually work in the clinics see the burden of remote monitoring. This has not replaced the other work. This has often been treated as something else to do at the end of your day, but it cannot be that. I think this is going to become the main work of a lot of the device clinics, and it needs to be staffed appropriately. So, in this document, for the first time, we tried to calculate the workload of remote monitoring to provide some guidance on how many full-time equivalents (FTEs) are needed so that the clinic staff can go to their administrators with some data. The challenge is that it is not going to be the same for every clinic, because there are some data that implantable loop recorder (ILR) monitoring takes up a lot more time and effort than pacemaker monitoring. Depending on the case mix in your clinic, this may be different. Dr Janet Han, who is on our writing committee, has created a calculator tool in Excel based on the published data, where you can enter the case mix that you have to give you an estimate of what is needed. We are going to try and get that on Heart Rhythm Society website.

Knight: I think those are valuable tools for doctors to get support from their administration.

Raj: Absolutely. Because it does take resources, time, effort, and money.

Knight: During COVID and post COVID, there was a lot of talk about working from home. Remote monitoring, by definition, is a perfect thing that could be done from home. So, assuming your team can access the EMR from home, we have our nurses doing remote monitoring from home with Epic access. So that has kind of addressed several issues.

Raj: Yes, it is a model that can work well. One of the challenges that a lot of people have with working from home is if you are sitting in clinic, I know you are in clinic. However, if you are not sitting in front of me, I do not know what you are doing. But these are broader issues that even in clinic, we need to figure out how to measure that workload, and I think it is absolutely going to be part of the future where not everyone has to be at their desk 5 days a week.

Knight: Let me present a scenario to raise the issue of follow-up for alerts. I see a patient with heart block and implant a pacemaker. Our device clinic runs pretty autonomously and we are always available for troubleshooting, but I may not see that patient for several years and they are followed by a cardiologist or primary care doctor. Seven years goes by, and they detect atrial fibrillation (AF). How do you handle that when I have not seen the patient? Should I see the patient? Who is responsible for initiating anticoagulation, assuming it is the appropriate thing to do?

Raj: That is a great question. Quite frankly, our model is very similar to yours. Our nurses are excellent. We have nurses exclusively in the clinic, not technicians, and they provide a certain level of patient care beyond just what is needed for the device. So, in our center, if it is something like AF and that decision is made, they usually run it by us as arrhythmia specialists. Every time they see that patient over the 7 years, if it has been that long, they still send me a copy of the remote interrogation and their conclusion, and if there is ever a concern, the understanding is that we will see them again. Certainly, if they need an operative upgrade, they would be seeing us. So in a case like that, I probably have that discussion with the patient. If it is a slam dunk discussion where there is no real question about the decision, we may then ask the nurses to communicate from the clinic to the other providers that are already seeing them to initiate anticoagulation. But we will be involved in that decision.

Knight: I think that must be part of the conversation, because starting anticoagulation also involves determining their risk of bleeding and other health care issues. You talked a little about the specifics of ILRs; what about the specific scenario of pediatrics? How do you manage that?

Raj: The rules are similar, but the case mix is different. The importance of patient education and getting the monitoring on quickly is the same. But obviously, the kids that require implantable devices often have significant structural heart abnormalities. They are certainly at risk of heart failure. Their susceptibility or their tolerance of arrhythmias is often less than in adults. So, while in theory if people otherwise are clinically well, we can space out visits for an alert-based program, the big “if” is if these other conditions allow it. Therefore, in many pediatric patients, they will need to be seen more frequently, not because of their device, but because of their underlying cardiac issues and their underlying risk of arrhythmias.

Knight: One of the biggest contributions, and one of the things I appreciated the most about this document, was the table. It summarized in great detail the differences between all the different remote monitors. Maybe you can highlight a couple. Some are cell phone-based and allow the patient to be more involved. Can you briefly summarize those critical differences?

Raj: The key differences are that some patients have a pacemaker or ICD model where it frequently checks in, typically on a daily basis, and tell you if something is wrong. There are other technologies that require more patient involvement or that are set up very much like a clinic visit except without the patient coming to clinic, where you want to get as regular information that something has happened. The other issue is there are some monitors where you do not know if they are connected or not. So, if you know that a monitor is going to ping in daily and it does not ping in, you can say “What happened?” after a few days. If it is a monitor that someone has to do something to transmit and you do not hear from them for a month, that may be just what they are doing, and you do not really know that the patients are protected or guarded or being watched in that time. That is probably the biggest difference. Obviously, every company has more subtle differences and one of the challenges in this particular time is it is not just a company-to-company difference. Within individual manufacturers, they have different technologies depending on their platform. I think that all are slowly shifting to more of a continuous cell phone-based platform. But right now, there is a lot of different technologies that clinic staff really have to be familiar with.

Knight: The term “standard of care” is used in the document. I am not sure that is used in any other consensus statement or guideline. It has a lot of medical-legal implications, at least in the United States. If something is the standard of care, that is the bare minimum. I understand the importance of emphasizing that maybe offering this as standard of care, but do you think it should be standard of care?

Raj: The last thing you said is probably the critical bit. These should be offered to everyone, especially as this technology evolves to the point where it is able to keep an eye on people at a frequency that is going to be impossible in clinic. But one of the other principles in the document is the important role of the patient as a partner, in day-to-day life in the clinic. In our clinic, for example, somewhere between 90%-95% of our ICD patients are on remote monitoring. While 100% of our patients are offered remote monitoring, there is a small percentage of patients who decline. We are not suggesting that you force remote monitoring on them. However, we are suggesting that you become part of an ongoing dialogue with the patient to try to educate them about the benefits of remote monitoring, and why we as providers think it is going to be beneficial to them. But ultimately, if the patient says no, then their answer is no. We are not suggesting that you be held liable for the patient’s decision.

Knight: Right. Anything else you want to add?

Raj: We try to look forward a little in this document to where we want to be. One of the challenges right now with care, especially in the US, is that the frequency of visits are driven by the Centers for Medicare and Medicaid Services (CMS). We see people every 3 months because that is what CMS will reimburse. We see ILRs every month because that is what CMS will reimburse. The truth is that most of those visits are nonactionable. From most of those visits, we find the device is doing well. The optimal payment model is that when someone is a patient of yours and you are a device clinic, you are responsible for trying to keep them well, and if they are not well, we are dealing with the issues and treating it. What we are advocating for is the beginning of a discussion about changing the payment model to shift towards less mandated visits and more alert-based care. So, we would be delivering care to people when they need it and with less visits. But that is going to take a broader discussion and partnership with payers, administrators, clinics, and patients, because it does not make sense for the insurer to say, “I am only going to pay you for a visit once a year,” when the truth is you are watching them daily and taking care of the patient all year.

Knight: It has to evolve.

Raj: We are talking about evolving to maybe a capitation model of care where we are taking responsibility as a clinic and providing care whether they are in front of you or they are in their home.

Knight: Thank you very much. This has been very enlightening to me and hopefully educational to all of you.

Raj: Thank you for having me.