Novel Research Demonstrates Improved Patient Outcomes and Reduced Health Care Resource Utilization: Part 2

Part 2 of Podcast Discussion With Rod Passman, MD, MSCE, FACC, FHRS, FAHA; Suneet Mittal, MD, FACC, FHRS; and Mintu Turakhia, MD, MAS, FACC, FHRS, FAHA

© 2024 HMP Global. All Rights Reserved.

Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of EP Lab Digest or HMP Global, their employees, and affiliates.

In this special 2-part series of The EP Edit podcast, Drs Rod Passman and Suneet Mittal join Dr Mintu Turakhia for a roundtable discussion on outcomes and new guidance in cardiac ambulatory monitoring. In the previous episode, they discussed the evolution of cardiac monitors from their inception to modern utilization, and introduced the objectives from the CAMELOT study. In this episode, Drs Passman, Mittal, and Turakhia continue the conversation and discuss the importance of the data gathered from these devices and how to incorporate it into clinical practice. Finally, they explore the impact monitor selection has on health care utilization and costs as well as clinical outcomes.

Mintu Turakhia, MD, MS: We saw something really curious in this data, which is that long-term continuous monitoring actually had less incremental health care utilization. Did that line up with your thinking prior to this, or how do you fit all that together? 

Rod Passman, MD: My response to that was that if we get a diagnosis the first time we have you wear something, we are going to avoid additional visits. We are going to avoid retesting with the same or other technologies. We may avoid ED visits. So, while I was somewhat surprised, in retrospect, I am not, because getting a diagnosis the first time and getting it right the first time actually saves a lot of potentially downstream serious events that are costly. 

Suneet Mittal, MD: Yes, and to me, this was like just something that I had not previously even thought about. When I use these as diagnostic devices, I am more thinking about, am I going to get a diagnostic yield? Am I going to have to retest the monitor? I really had not even actively thought about what the implications could be to health care utilization. I thought it was great that we took the opportunity to test for this and are able to show this, because it is almost like a eureka moment and it allows you to say that not only are you making an impact to that patient, but on a more global scale, and I think we want to be good stewards of the health care system, that this is really another win and it speaks to the triple aim that we are all trying to achieve. 

Rod Passman, MD: Yes, I agree as well, and I think this is an interesting time. I love the history of these devices. If you go back 100 years with Einthoven doing an ECG, the device took up a room. When you look at those early pictures of Norman Holter, he was carrying an 85-pound box on his back while on a bicycle. That was not that long ago. It was not that long ago where you had to bring people into the hospital to monitor the rhythm of their hearts. So, to me, this concept has really exploded over time, and I think we are in an interesting time. We can speak about it, and it is beyond the scope of what we have written about, but medical grade wearables are just a piece of the puzzle. Will this be a continuum of care? These patients will sometimes get a medical grade device, sometimes get a consumer device, or there are some patients where an implantable might be a good answer. So, in my opinion, it is being aware of the options and really fitting the option with the patient. I probably speak for all of us in the EP world that when we see patients who have syncope and come to us with a 24-hour Holter and it is negative, we just want to put our head down and say, "Why did you do that?" To me, if we could just educate our referring physicians on the options and to match those to the patient's needs with what we have to offer, that would be a win. 

Mintu Turakhia, MD, MS: And retesting has an economic burden to the patient, not just the payer. There is a copayment often in Medicare. You can deplete your Medicare reserves. There are a lot of other reasons that are on the patient side to avoid retesting, including their own burden. Rod, I want to go back to a point you just mentioned on ambulatory monitoring and this whole landscape of monitoring. I think this goes to access. So, one is, of course, clinicians picking the right monitor for the right patient. We talked about that. The other is making sure they get the monitor to them, and it is worn. You did something very interesting that was published in Heart Rhythm about a year and a half ago,¹ exploiting some of the learnings at Northwestern with the pandemic and this ability to send a device directly to the patient's home. This was with the iRhythm long-term continuous monitor, but I think the findings are highly relevant and I am wondering if you can walk us through that study and what the learnings are.

Rod Passman, MD: Sure. So, first, a bit of history, before Covid-19, if you got a monitor at my institution, you would need to come in and get that monitor placed by our technician, who would prep your skin and tell you what to do. That meant you needed to take time off work, find perhaps caregivers for your little ones or elderly, pay for parking at Northwestern, which is not trivial, and then get it put on. When Covid hit and people did not come in, now we had a difficult situation. We actually started to mail the long-term cardiac monitors to patients. So, now we had a pre-Covid cohort, and then even within the Covid cohort, some patients came in and some patients got it mailed. As you said, when there are differences in practice patterns, that also creates opportunity for research. What we asked was, what were the chances that someone was going to get the device, put it on, have wearable data time, and not create so much noise in the system because they did not prep themselves very well? Those were the kind of questions we wanted to answer. To my surprise, I will tell you, yes, there was a very small number of patients where they just never got the device or it was mailed to the wrong place or they did not put it on correctly, but that was very low single digits. The other surprising thing is that patients were more likely to wear the device longer during Covid because they were not going to work. But what was really most impressive to me is the amount of usable data was the same. It was like 95% plus, if not higher, showing that patients are perfectly capable of receiving this at their home, prepping themselves, putting it on, wearing it for the prescribed period, and getting highly usable data back to us. So now, we actually do not have patients come in anymore. We mail it to them. 

Mintu Turakhia, MD, MS: Yes, it is fascinating and I would say that iRhythm learned a lot from that experience. We obviously look at our global data on home enrollment also, and very carefully follow quality and everything. In fact, we look at wear times during heat waves and changes in humidity—you would be surprised at how many amazing things we have data on. But here, what we learned a lot from you is what can we do to improve the patient experience? So now there is a version 2.0 update on the MyZio app. It is not required, but patients can use it. It tells you when the thing is going to arrive. It tells you how long you need to wear it. If you have questions about going through airport security, it is all there for you. Then, it reminds you to mail it back, where it is in queue, and when it is ready for your doctor. So again, I think we are learning a lot here and it goes back to a broader theme, not just in monitoring, but the fact that diagnostics have been disintermediated in a good way from brick and mortar.

Suneet Mittal, MD: I would like to also add to Rod's experience another approach we have taken at Valley Hospital, which is we realize that whether it is home mailed or in-person applied, patients were being referred to us so often after they had an initial health care encounter with a primary care provider. As you know, the data in the United States is that it can often take 3 to 4 weeks for a patient to get an appointment with a cardiologist in the United States or longer. It did an unnecessary delay. So, one of the things that we have tried, which has been really helpful early on, is for the primary care doctors to be able to apply the monitor in the practice when the patient is in front of them. Then, we can read those monitors and help triage for our colleagues what is going on. Is this someone that we can reassure based on the finding, and thus, save an unnecessary visit to a cardiologist, opening access to a much-needed appointment slot? Or is this someone who really would benefit from further evaluation? If so, rapidly expedite those appointments. That has been a big satisfier, both for the primary care physicians as well as the patients. So, that is another approach in trying to have a model of care that makes sense and moves it outside of the more traditional model of having a cardiologist be involved every time a monitor is needed.

Rod Passman, MD: I would expand on that because what we have been doing is, typically if we see someone a few months after an ablation or cardioversion or initiation of a drug, the old model was you would see the person, you would get the monitor, and you would have to then get in touch with them and go over it. Now, we send the monitor to them, so by the time we see them, we have that result. The patients love it, we love it, and is a much more efficient use of this technology in the time that we have.

Mintu Turakhia, MD, MS: It sounds like a win in a few ways. One, for the patient, it is a faster time to diagnosis. For the primary care doctor, I am assuming less angst while the patient is sitting there waiting for a visit to be seen. But it may actually take those patients who have negative studies and reassure them full stop so that they are not actually going to the EP clinic where you are not likely to be able to offer them anything because they are doing great and they have nothing observable. Have you seen that bear out in the volumes of the EP clinic where the patients who have normal or near-normal ambulatory cardiac monitoring do not have to come in to you? 

Suneet Mittal, MD: Definitely. We are seeing much less of that. Again, I think the primary care providers are just looking for reassurance, so for us to be able to really collaborate with them and get them and their patients and answer in a more rapid fashion has been a real win-win across the health system. 

Mintu Turakhia, MD, MS: Has it increased monitoring and primary care beyond patients who would otherwise be referred? So, you do not want to test everyone, but there is this always worry upstream in care that patients are not getting the right things they need, and it is not until they see a specialist they get it. But are you seeing the funnel widen or are the primary care doctors in your system prescribing them appropriately, but across greater indications, complaints, or symptoms? Has it increased their awareness that this is available? 

Suneet Mittal, MD: I am not sure that I have the objective data to know whether it is increased the number of referrals or the number of monitors they are applying. I do feel that with us helping them intervene in the process, that their patients were probably getting better care. A classic example is the patient with premature ventricular contractions (PVCs). For many primary care doctors, when they get a monitor back that just shows PVCs, often think of that as a very innocent or benign condition. They are often surprised when we explain to them that on the monitor, we can tell the burden is high and it is a unifocal PVC, and maybe this patient would do well with an antiarrhythmic drug or catheter ablation procedure. So, there are patients in the system who I feel would have gone on longer having been thought to have a benign condition who are now being referred forward for more therapeutic approaches that are really going to help their quality of life. 

Mintu Turakhia, MD, MS: That is great to hear. So, I want to go back to something you said about commoditization and how a monitor is a monitor, or that is the thinking, or a patch is a patch. There was an interesting analysis we did in CAMELOT, which was not only to look across categories as you described, so long-term versus Holter versus MCT versus event, but looking within categories, looking within that column of long-term continuous across the different manufacturers and the different technologies. Talk us through those findings and what you learned.

Suneet Mittal, MD: Yes, so I thought that this was a very innovative portion of the study design, and while it was not possible obviously to study every possible vendor who makes these devices, we are able to study some of the ones that have larger market share in the United States. Historically, we do not think that the choice of monitor manufacturer should have any difference in diagnostic yield. Here we learn that, for example, the Zio long-term cardiac monitor outperformed in diagnostic yield at retesting and health care utilization relative to the other manufacturers as we studied. This is really an important concept because, number one, we have for the first time some objective information that this is an issue that we should be considering when we have choices. But now we also have more opportunities for research to really understand why that is and there are many things that we must speculate. Is it the form factor of a device? Is it that one has more wearable time than the other? Or should we really be thinking about the algorithms that go back into data analysis? Does one manufacturer have a more robust algorithm detection for arrhythmia detection? Are their models better trained than the other? So, it opens an entire new avenue of research that needs to be done, that until now we really had no insight into.

Rod Passman, MD: I would agree. I think that many institutions like my own, we only deal with one company, and so there is not a lot of latitude. But I do think there would be a mistake to equate all these devices or long-term cardiac monitors, for example, and as Suneet pointed out, there are many potential reasons. The question is why. Is wearability compliance different, is usable data different, or is it an interpretation of the algorithms? This is a black box to us. We send the device to you and get a report back, and yes, we get examples of abnormalities, but we do not get every example. So, there is certainly a lot of potential room for variability in the way this data is processed, analyzed, and what we see as consumers.

Mintu Turakhia, MD, MS: These are great points, and it could be all those things Suneet, as you nicely articulated. I think one of the interesting things is this sort of tradeoff, so to speak, between this idea that you want 30 days of data. There is a lot of anchoring to 30. Thirty is just a number that is used a lot in medicine, but patients cannot wear something continuously for 30 days. So, is it the form factor where it is uninterrupted, they can live on with their lives, and go the full 14 days? Then, one may ask, do you go longer, do we create new things? Both of you, I think, have used the product update we have with the Zio monitor, and the thing that keeps us up at night is that we want to make sure this is going to outperform what we already have. Because if it is all those things, the AI backbone is the same, the report is the same, but if things change with the wear time, things can change, right? So luckily, the data bears out that if anything, it is even superior and that has been presented before. But now that we are here, we have CAMELOT, it is a Medicare population, we still have to learn about other systems, health systems, payment models, think more broadly. Where do we go from here? 

Suneet Mittal, MD: One thing before we talk about that that I did want to mention is that we are, of course, very proud of CAMELOT. But it is always nice when the findings of the study can be corroborated by others. I think it is worth mentioning, at least briefly, a beautiful study that our colleagues at the University of Pennsylvania did, which I think was a really unique design where they took the same individual patient with a history of AF and were able to apply long-term cardiac monitoring and a mobile cardiac telemetry monitor on the same patient at the same time. Now, obviously, this cannot be done in routine clinical practice, but it was a beautiful proof-of-principle study, and they were able to very nicely corroborate the findings we had, that the long-term monitor outperformed mobile telemetry monitoring, and in fact, showed beautiful examples of AF that was detected by one device and completely missed with the other. So, I think we really do now have corroborating evidence that the choice of monitor makes a really big difference and now we can really engage in this issue. Then, as we fast forward, the things we want to look at are even more contemporary data sets; this data set was 4 or 5 years old, and over that time, there has been a greater and greater use of these longer-term monitors. We want to see it in patients who are not Medicare, we want to see a commercial class of patients who are going to be younger and bring their own set of issues, and we certainly want to do it in the new form factor devices, which hopefully, in addition to better use time and compliance, will be coupled to more robust algorithms that are constantly being fine-tuned. So, there is a lot of opportunity to extend these findings to more contemporary practices. 

Rod Passman, MD: I would totally agree from a data perspective. Are you asking us as well from a technology perspective? Because I think that if you have a monitor on someone for 2 weeks, that is a wealth of information. Can we get more information on that individual about their sleep and their activity levels? As you and others have published, can you predict future events, future AF events, future heart failure events? So, I think there is a lot of rich data there that we have yet to fully mine, but to me, this is only the beginning. 

Mintu Turakhia, MD, MS: It is a fascinating point, and we think about this a lot where we are getting to that next leap where the technology is going to outpace our ability to understand where we put it. So, what you mentioned, what are the adjacent areas around arrhythmias? Sleep is critical, activity is critical, getting context around these arrhythmias is important. What we may see in the future is more sensors, more data, and better AI. Could you find, to your point, the NPJ Digital Medicine study done by our Scripps colleagues in partnership with iRhythm, which took patients who had a negative 14-day monitor, meaning negative for AF, sinus rhythm, but they could identify those who are at higher risk for near-term AF.² So, could you then say there is a likelihood based on a risk model that there is risk for AF and maybe it is worth retesting, or you have high negative predictive value to say you are good, you do not need to retest. All those things. Well, I think we are going to be wrapping up soon, but I want to give each of you the last word here on how you think of this data, what is in store for the future, and what monitoring may look like 5 or 10 years down the road.

Suneet Mittal, MD: At a time in our field, there is a lot of excitement about procedures that we are doing, novel ablations and devices. I think it is good to really extend the discussion on something that is bread and butter in routine clinical practice. There are thousands and thousands of these monitors being ordered across the United States and worldwide, and with a real paucity of data. So, I think that it is really the first time we can have a robust conversation about monitor type, monitor duration, implications for patient well-being, predictive analytics, and form factor, whether it is a patch or a watch or a ring. There are 1000 different ways to go with this, and I am really excited about the fact that CAMELOT paves the way to continue these observations and understanding studies so that 5 years from now, we are ordering the right test for the right patient at the right time. 

Rod Passman, MD: That is really well said. I think I would like to see sort of a blended continuum of monitoring. For some patients, wearing a long-term cardiac monitor for a few weeks may put you in a situation where ongoing continuing monitoring may be reasonable and that may be a combination of facial photoplethysmography and ballistocardiography and all these interesting other ways of monitoring people, even through non-contact means. So, I think what we are learning is that monitoring the way we do it now is a snapshot in time, and that there is a threshold for how much monitoring you can do on someone in a wearable format. So, I think that the future will be a combination, and that will identify patients who benefit from what type of monitoring through medical grade devices, but ultimately, it will be a combination of consumer and medical grade. 

Mintu Turakhia, MD, MS: Well said, both of you. I want to thank our guests today, Dr Rod Passman and Dr Suneet Mittal. As always, I learn so much from both of you, hearing about the insights, your view on the future, and your passion for the field. So, thank you so much for joining us. Thanks to our listeners for joining us on The EP Edit podcast. My name is Mintu Turakhia, and thank you.

The transcripts have been edited for clarity and length.

This content was published with support from iRhythm Technologies.

References

1.     Goergen J, Peigh G, Hsu M, et al. Comparison of data quality and monitoring completion rates between clinic and self-applied ECG patches. Heart Rhythm. 2023;20(3):407-413. Epub 2022 Dec 1. doi:10.1016/j.hrthm.2022.11.020

2.     Gadaleta M, Harrington P, Barnhill E, et al. Prediction of atrial fibrillation from at-home single-lead ECG signals without arrhythmias. NPJ Digit Med. 2023;6(1):229. doi:10.1038/s41746-023-00966-w