Hi, everybody. Thanks again for joining us today for a diagnostic pathway post cryptogenic stroke. We know that is exactly one o'clock and you're penalized for being on time because we are going to wait just a minute or two for folks to join. We see them popping into the system now, so I'd like to make sure they all can get connected to audio. We're going to sit tight for just a minute or two, and then we will begin the webinar. Thank you so much. Okay, everybody, we're going to give it just one more minute, and then we'll begin. Thank you. Okay. We will now begin the webinar, and we will let others continue to come in as they may. My name is Joe Sasson. I'm the Executive Vice President of MedAxiom Ventures, and today I'm really happy to bring you a presentation by Dr. Najeeb Chalfoon with Spectrum Health. Today's presentation is a diagnostic pathway post cryptogenic stroke. Before we get into the presentation and an introduction of Dr. Chalfoon, if we could give me the next slide, I wanted to make sure that we're all familiar with using Zoom webinars. At the bottom of the panel, you will see a chat button. If you open up the chat and if you see that highlight for you, you will find a link to today's presentation, and you'll be able to download that. We may also post that link throughout the session so that those who joined late will also be able to see it. You will not be able to communicate with the host, with the presenters, or with any of the organizers for this event. To do that, we use the Q&A button and use the Q&A box. I want everybody to use that if you have any questions or if there's a technical difficulty or something you'd like to ask us, that's great. Please use that function. And then throughout the webinar today and the instruction by Dr. Chalfoon, please send us your questions. We will ask them towards the end of the presentation, but we will make sure they all get answered today. If for some reason we can't get them all answered in the time we've allotted, we'll follow up by email to make sure that you get answers, additional resources, or guidance. So please use that Q&A box. Next slide. And so our speaker today that I'm very pleased to introduce is Dr. Najib Chalfoon, and he is the Senior Academic Advisor for Cardiac Electrophysiology at Spectrum Health. He's also the Program Director for Cardiology for Fellowships at Spectrum Health and Michigan State University, and he's also an Associate Professor of Medicine at Michigan State University. He is also one of the leaders of Spectrum Health HeartBrain team, which he is speaking with us today on. So Dr. Chalfoon, thank you so much for joining us. I'm going to turn it over to you, and I'll pop back on at the end during Q&A. So thank you. Thank you, Joe. And thank you all for taking the time to join us today. Thanks to the MedAxiom team as well for inviting me to speak on this important topic. It's been a passion of ours for many years now, and I'll tell you a little bit about our journey. First, let me tell you a little bit about my disclosures. I do give, I'm a consultant for Medtronic as well as Attracure, and I do have a speaker in our area from them. So as far as objectives, my goal today is really hopefully for this to be an interactive session to tell you a little bit about our experience with cryptogenic stroke and our pathway with using intracardiac monitoring. I'll first start by telling you the importance of atrial fibrillation detection with cryptogenic stroke patients. I'm an electrophysiologist, and so for us, detecting atrial fibrillation was very important, especially in our patients that are at the highest risk of strokes, which are the patients that have already had stroke. And then I'd like to tell you about how we went ahead and started a pathway for ICM with our neurology team. It's been a team approach to this, and they've been our collaborators in this and a very important part of the pathway. We'd like to highlight some of our success factors for developing a multidisciplinary approach in the hospital and understanding how to measure those metrics and how to maintain a program like this. Also important, and just as important as everything else, is to discuss with your patients the education about having a link and what it means to them. And then finally, in this world that we all live in, a cost-effectiveness analysis, a little bit of what it means to put in links with different strategies, and we'll discuss our approach to that. So just a little bit about where I work and Spectrum Health. Spectrum Health is a large hospital system made up of 14 hospitals and over 6.5 billion enterprise. And now recently this past year, you may have heard we joined with Beaumont Health as well, also another very large hospital system, and a major employer in the area, and see a lot of strokes through the year. And we'll be talking about those statistics as well. So let's talk first about atrial fibrillation and why we need to be looking out for this in the world of stroke. We know it's an epidemic. The chart on the right you can see is exponentially growing. By 2030, we're going to have over 12 million people expected to have atrial fibrillation. We need to really clone electrophysiologists and cardiologists. So we need to not only be able to diagnose it, but treat it. So why is AFib bad? Well, five times risk of stroke, three times risk of heart failure, increased dementia, increased mortality, and not including all the morbidity and the symptoms that patients have with atrial fibrillation. We have known that detecting AFib and treating it with anticoagulation will help stroke production in the future. But we're also finding out that even treating atrial fibrillation, even symptom relief now may even have cardiovascular benefit outcomes as well, going back to normal rhythm. So we need to be able to treat it earlier. And lastly, we need to be able to deliver high quality, but also value-based care. So we have a lot on our hands with atrial fibrillation, but again, the importance of trying to set up a system in your hospital systems to deal with this. So atrial fibrillation accounts actually for almost 20 to 25% of all strokes. And the 25% of strokes, the first manifestation is actually atrial fibrillation. And that's been repeatedly shown. So when you have strokes, we talk about, our talk today is about cryptogenic stroke. And what does that mean exactly? Well, there is a toast definition that neurologists use that includes these three definitions for cryptogenic stroke, which is a stroke, an ischemic stroke with two or more causes or a negative evaluation or an incomplete evaluation. What we're really kind of interested in is this kind of more defined definition of what you'll hear as ESUS, which is embolic stroke of undetermined source, which that concept emerged in 2014. And this is a stroke that's presumed to be embolic and specifically a non-Lacuna stroke without any major identifiable ideology. So basically a cryptogenic stroke that has had a full negative evaluation that you suspect is going to be embolic. So cryptogenic strokes account for a large part of ischemic strokes, almost a quarter of patients don't really have a good ideology for. And then as I will show you the data, almost 30% of those patients with cryptogenic stroke were eventually found to have atrial fibrillation. And this is kind of the crux of our talk today. In our hospital, in our hospital system, I should say, we have about 450 or so cryptogenic strokes per year. So for us, it was really important when data started coming about how to detect these to try to address this large patient population. So what tools did we have available and still have available to detect atrial fibrillation? This is kind of all the ones that are available to date, a Holter monitor, which is basically a continuous monitoring for 24 to 48 hours. You know, I'm not sure how and why to use these because most patients that are in the hospital for 24 hours post-stroke or 48 hours are on telemetry. So this is a very short monitoring system. An auto-trigger event monitor, that's usually about 30 days. It automatically sends you a few seconds worth of the arrhythmia, and it gives you, it can't give you instantaneous detection. The downside to that is that you don't get a percent burden, if you would, of atrial fibrillation, and it's only about 30 days. The Xeo patches came out last 10 years or so, and really have been used quite a bit. A nice patch monitor, last two weeks, and you could put more than one on. That gives you the continuous burden, but the disadvantage is it is the duration of time that you put it on, and also it doesn't tell you immediately when somebody goes into the arrhythmia. You have to wait until those patches are turned in and you have the report back. So someone may have had AFib again, especially if they're at high risk of stroke, you may not get those results for weeks until after they develop their repeated episode of atrial fibrillation. The MCOT is the 30-day version of continuous monitoring, but the advantage of that is it is instantaneous detection as well, and cannot notify your team that the patient is having atrial fibrillation. The disadvantage of that, it is more costly, and nowadays, it used to be more inconvenient, but nowadays they have patches for those as well. You've probably, if you're dealing with patient care, and especially if you're in the cardiology world, you've had a lot of patients that have sent you, nowadays, Apple Watch tracings or CardioMobile tracings, wanting to know if they're having arrhythmia because they're watched all the time. Maybe they have atrial fibrillation. This is something we're going to have to learn to deal with as a medical community. Again, we're going to be inundated with strips from our patients on rhythms. That is now available. The CardioMobile, you actually have to, the patient has to initiate it and start the ECG. The Apple Watch can be set to actually detect for any irregularities, then notify you, and then you have to take an EKG of it. There's some variations now, too, besides the Apple Watch. Other makers are doing this. Implantable loop monitors, which is going to be our concentration today, which was basically a monitor implanted underneath the skin that can last three to four years, and also has instantaneous detections and monitoring and communication to your teams. Finally, not to forget the old dual-chamber pacemakers and defibrillators. If you have an atrial lead, you'll be able to detect the arrhythmias. Those are important, as well, in a large part of our monitoring system for patients. Of course, those only are in patients that have the indication for those devices. This is a picture of what the loop recorders look like, small little devices. Most of them, multiple different companies now have them about the same sizes and go in about the same area. This is the CardioMobile, the handheld device I was telling you about, or the Apple Watches or similar watches. This epidemic is just growing again. The more information you can access, the more you look for it, the more you will find. I wanted to show you the landmark trial that, for us, really initiated our journey with this. This was published. This is the CRYSTAL-AF trial that was published in the New England Journal in 2014 that really showed that the longer you monitor in post-stroke patients for atrial fibrillation, the more you will find. This basically looked at intracardiac monitoring with a loop recorder versus standard monitoring and showed that by six months, 12 months, or 36 months, when you compare the intracardiac monitor, there is over an 8.8-fold difference between the control group and the intra-ICM groups. When we saw this, we were very early adopters of this. It made sense to us. As electrophysiologists, we know that atrial fibrillation is very paroxysmal. There was data already with devices, pacemakers, that sometimes you may not develop a stroke until weeks or months after your episode of atrial fibrillation. We were early adopters of this concept that the longer we will monitor our post-stroke patients, the more AFib we may end up finding, and we wanted to provide this crucial care for our patients. I'll tell you a little bit more about our journey a little bit later in the talk. There's been several papers that have come out, including some meta-analyses that looked at different longer monitoring versus the traditional short 24- to 48-hour monitors, and showed that the longer you monitor, of course, the more AFib you'll detect, but also some modeled and looked at strokes and reduced 55% decreased recurrent stroke if you monitor longer. These are some simulated monitoring systems of, say, an intracartic monitor versus a 24-hour holter versus a 21-day or a 30-day or multiple holters, even 12 monthly 24-hour holters here. You can see, really, the best you'll get with those is usually somewhere between 20% to 25% sensitivity for atrial fibrillation, even if you repeatedly test these. Remember, some of these testings are several hundred dollars and sometimes approaching $1,000 if you're talking about the 30-day deals. Clearly after the CRYSTAL-AF trial for us, it made a lot of sense that 30 days is just not enough. If you were to look at that data, then about 88% of patients you would have missed if you had not monitored them for that year. The other thing you have to think about is if you just do short-term monitoring and you do end up believing in long-term monitoring with an ILR, you may not have those patients come back to get those placed due to loss of follow-up or just going through different systems at different hospitals. the loss of patient follow-up to implanting a longer-term monitor needs to be thought about when you're seeing the patients before discharge. And then there's been some, there was one cost-effectiveness analysis that was done by Sawyer and his team that showed that if you were to look at the CRYSTAL-AF trial and included stroke analysis and the potential cost savings of this, they'd actually become cost-efficient to put in long-term monitors with ICMs instead of short-term monitoring. And we'll get into that a little bit later as well. The European Heart Association, the Heart Rhythm Society, also recently in the last few years, in 2020, came out with the recommendations that the use of an ILR should be considered. I don't know if you can see my mouse here, but this is the fourth heart, green heart there. It should be considered for the detection of AFib in patients post-stroke who do have higher risk factors for atrial fibrillation detection. So where did we start with all this? Again, CRYSTAL-AF was our big kind of impetus to this. But prior to that, we had developed an atrial fibrillation clinic. And what I want you to get out of this talk is that this is not a one physician or one subspecialty approach. It's a multidisciplinary approach to be able to deal with and treating these patients and diagnosing these patients appropriately. So for us, we had developed an atrial fibrillation clinic and where our patients are seen early within 48 to 72 hours with an advanced practice provider and a nurse that help us keep our AFib clinic running. We have a standardized approach to both detecting and to treating atrial fibrillation and modifying risk factors. We have education periods with our nurses and our advanced practice providers, even before they see the attending physicians after the workups are done. And it starts with the emergency room with the referral to the atrial fibrillation clinic, which also has been a tremendous support with a standardized protocol. When we started looking at strokes in our patients after CRYSTAL-AF, we decided to collaborate with our neurology team about developing standardized protocols that are going to make sure that our patients have the best care that we thought was possible for them. And after this data came out, it really solidified to us that the longer we were going to monitor for atrial fibrillation post-stroke, the more we were going to pick up patients with atrial fibrillation. So we started early on implanting cardiac monitors before discharge. And you can see that the 2014 was the trial publication. And before that, really our loop recorders were, you know, were under 50 a year or so. And then after that, and this has been pretty consistent, is we have over 250 to 300 links per year implanted that meet our criteria. At this point, we have about 700 to 800 patients yearly enrolled in our ICM clinic. And that clinic is staffed full-time with staff. You are currently our exercise physiologists that look at the strips for us and send them on to the attending physicians after they are screened. So who else is part of this AFib stroke program? You know, this is a slide that you may have seen in our presentations, but this is kind of crucial to us. This is our, what we really believe in, in terms of treating atrial fibrillation patients, not just for stroke, but AFib as a whole. Obviously we're on the electrophysiology team here, but especially with stroke, our neurology team is crucial to diagnosing the strokes and sending them on to electrophysiology. Our emergency department sees those patients initially as well, often, and are probably the people that send the most atrial fibrillation to the electrophysiology team. Cardiothoracic surgery, if we're going to be doing maze procedures, metabolic wellness is very important. We have our weight loss exercise specialists and nutritionists that are a part of this crucial program. Our structural heart teams for PFO closures and stroke and left atrial appendage closures. Our cardiovascular imaging team. We have an advanced imaging team that looks specifically at high-risk markers and help with our structural team during their procedures. High-risk medication clinic for our anticoagulation patients that are being monitored and the anti-arrhythmics and sleep medicine for sleep apnea treatment and reduction of atrial fibrillation. Again, to do all this is a team sport. So we developed this cryptogenic stroke protocol and this is, you know, we revise this every couple of years as more data comes out. Just sharing this with you, you can, you know, sit down with your teams and develop one that makes sense to for you and your team, but effectively we have differentiations between age and whether they have a PFO or not, and then how many risk factors they have for their atrial fibrillation, but a low threshold for proceeding to a implantable loop reporter prior to discharge in patients that we think are going to be high risk. And for those that we're not sure about, then we bring them to our heart-brain team and our brain-heart team, and I guess it depends on which side you're on, whether you put brain-heart first or heart-brain, but they're both equally important. And this is something we're very proud of that's kind of developed over the last several years, driven by all the collaborations between our neurology team and our cardiology team and our structural cardiology and electrophysiology and our vascular neurologists. And really something we're proud of because this is a team that meets monthly and compromised of those, you know, electrophysiology, structural cardiology, and vascular, but also having advanced practice providers and nurse that will help us coordinate the cases that are sent. Topics that we deal with on this are cryptogenic stroke, ESUS patients and who and who shouldn't get links or further workups. The images are all reviewed. PFO closures, who should have it, should not have it, especially those that have questions, and then left atrial appendage closures. So this is a really a nice forum where multidisciplinary physicians can can bring difficult cases. Cases can be either brought by the neurologist from the stroke side and inpatients, or it can be actually referred even as outpatients to be considered. And actually a formal recommendation is made in place in the chart for the providers and sent to their primary care physicians as well. So keys to starting these cryptogenic stroke programs and pathways. I think that the one of the most important aspects is that, again, I keep saying team, but you have to be able to build the team. And for that, you need hospital leadership support. And you have to have the right and appropriate resources in place. There is no way that, you know, as an electrophysiologist, I'd be able to screen all the several hundred patients, link reports that come in on a regular basis and see which ones are real, which ones are true abnormalities. You know, with these reports, we don't just diagnose AFib. We also see critical pauses or malignant arrhythmia. So there's a lot to be dealt with. There's no way I would know that there is somebody who came in with a stroke without the appropriate either ED team and neurology team or hospitalist team letting us know of these patients. So it becomes really critical for you to find out who are the, who are the players in this? Well, the ED neurology, obviously, you know, with the strokes, but also the hospitalists. So our, our protocol has really made it so that our hospitalists are aware that, that patients with, with cryptogenic strokes need to have a neurology consult. We will usually have our neurology team be the ones to be able to triage through that protocol that I showed you and order the consult to be done for us for, for an implantable loop recorder. And that's why it's so important to have the, the, the clinical pathways in place and standardization because people know that, okay, cryptogenic stroke, we have a standard protocol for this. Let's look at that and let's consult neurology. Neurology will look at evaluate the patients that they truly believe it's a potential ESUS patient. They'll go ahead and consult us. And then we'll try to implant those devices before hospital discharge. And as an outpatient, same process, except they would come in and have an expedited work, work up with our advanced practice providers. We're trying to work into even using virtual visits for outlying hospitals. And those are all things you can work together to create a pathway to expedite the process for your patients. Focus on standardized approaches. It'll reduce mistakes. It'll increase your, your, your referrals and not miss patients that need this, this care and it'll improve your quality. And lastly, I'm going to stress this multiple times through this talk, but we really need to educate the patients and their family on what they're having implanted. And, and I'll show you examples of why that's important. So where has this taken us? I mentioned to you about 7,800 LYNC patients. We, we predominantly use the, the LYNC Medtronic implantable loop recorder, but we also have other vendors. And that's something that you'll have to decide with your hospital systems what works for your systems. But we, we've our firm believers that long-term monitoring is important for our post cryptogenic stroke patients. We established standard work protocols. I mentioned to you with our protocols, including our heart brain team for those complicated patients as well. And those that we have questions about, we have an established monitoring team that I was telling you about is crucial for us because they're the first ones that screen all those downloaded monitors that come through every several months from those links. You can imagine even for, we have eight electrophysiologists at our institution and there would be no way we'd be able to get through 800 downloads monthly or every three months and screen them and make sure that they're all appropriate without the, our monitoring team. They've created the reports for us. They scan them in and we can read them and evaluate them. And they also, if there is something that's critical they're able to call the patient, call our, our nursing staff, and we can give the patient a quick and rapid care if they need it. Typically, if somebody is a staff that has diagnosis of say atrial fibrillation on their monitor, we'll, as soon as we have the monitoring team send us the report, we'll have them either begin anticoagulation if we've seen the patient recently or bring them into our AFib clinic, which we'll see them within the 48 to 72 hours. I would tell you that developing relationships is important, whether you're developing a stroke program or not, but it is especially important if you're developing a multidisciplinary program. And we have wonderful relationships with our neurologists and our hospitalists. It's a streamline this. So it's something that they can request a link the same day of discharge and we'll, we'll get this done before the patient leaves that day if needed. Education, critical for the patient. We have a lot of pamphlets to the patient. Our team will actually meet with the patient before they leave the hospital. And we make sure that the patient is aligned to follow up with our AFib clinic in the future should they need it. So why is this important for the patient to be educated? Well, first they have to understand why they're having these monitors placed. And I think this is important not just for the patient that's coming in with their stroke, but also make sure you have the family available because some of the patients may forget the discussions you've had, especially due to their strokes. You know, show them how to use the monitors and also importantly, the expenses associated with this. You know, early on we were finding out some patients were discontinuing follow-up because of the out-of-pocket expenses they may have had after they had the links placed. And so our monitoring team does a nice job of meeting with the patients before they leave the hospital to tell them about the potential costs down the road of monitoring and what their options are in terms of continuing monitoring or discontinuing monitoring. All right. So I hope I was able to cover so far the importance of detecting atrial fibrillation in stroke patients, especially. And our journey in terms of why we felt that it was important to do this before discharge and implanting an ICM before discharge. And that looking for atrial fibrillation longer, you will find more AFib. And then how to develop a program with a multidisciplinary approach to patient care with the collaboration of especially neurology and of course, hospital's team and ER. Now I'd like to tell you about some of the cost effectiveness of this. Obviously these devices are expensive. This was a study that was nicely done published by Sawyer and their team in 2020, looking at the crystal AF population and modeling what it would have cost to do the link versus the standard monitoring, including the cost of strokes and how many strokes you potentially could save based on detection of atrial fibrillation. They found that you had 60 fewer ischemic strokes per 1000 patients, if you were to go ahead with the ICM upfront, and then that will be cost effectiveness when you include the cost of hospitalizations of recurrent strokes down the road as well. That would basically eventually outweigh the cost of the ICM. We actually just published this paper in the American Heart Journal plus cardiology research and practice. We chose to look at a little bit different aspect of cost analysis and our strategy was basically to look at the cost of immediate ICM implant versus the multiple other modalities that are available to you, presuming that you believe that long-term ICM was going to be important for that patient post-stroke before discharge, and then comparing the cost of that short-term strategy versus an immediate long-term strategy implant with the ICM, and then whoever had the short-term strategy that was not diagnosed with atrial fibrillation, that they would then end up with an ICM afterwards, because again I said you believe in the fact that those patients were going to need an ICM to detect atrial fibrillation for the ESUS patients. So what we did was we went back to our patients that had an ICM implanted post-stroke after that CRYSTAL-AF trial. As I mentioned to you, we're firm believers that this made sense that that AFib is paroxysmal and these patients are at higher risk of developing AFib, and we looked back at those same patients and the mean follow-up for us was about six months, and we then looked at the detection of times with atrial fibrillation on the link for both a two-week period and a 30-day period, because we simulated that had we potentially put in either a two-week monitor or a 30-day to monitor and then implanted a link, what would the cost have been as opposed to doing what we had done, which was implanting the link on front. We wanted to make sure we were good stewards of our medical system and Medicare and patient costs. And so we looked at seeing whether that was a wise thing to do from a cost standpoint. And what we found was this. Well, in our patient population, we found about 7% of patients were diagnosed with AFib at 14 days, 9% at 30 days, and about 17% in a medium of six months, not too far off from the data that was published in some of the other trials looking at ICM implant for AFib detection. Now, if we were to take those same 93% patients that didn't get their link implanted at the 14-day mark or the 90-plus percent of patients that didn't get at the 30-day mark and implanted an ICM cost, we compared the cost of that, that total additive cost, including all the monitors that we had to put in and 100% of those patients, right, upfront. And we found that had we put in the ICM upfront first, we were actually saving somewhere between $3,600 to $4,000 in Medicare costs. And actually for the patient, for Medicare patient out-of-pocket was actually cheaper as well, $1,400 to $1,500. We then said, well, it'd be interesting to see if this applies the strategy of ICM comparison first to detected AFib patients on an ICM, whether that compared to other patient populations, not just ours, but we compared to the per diem stroke patients and the stroke AF patients we looked at all ischemic stroke patients. And those were large trials published last year. And we found very similar cost effectiveness in those patient populations as well, that if you were to put in an ICM upfront as opposed to putting an ICM after you've done 100% of monitors in everyone, that that differential is actually cost-saving because you end up not having wasted all that potential cost of the monitors because you would have missed a lot of people upfront. In our patient population, you would have missed 90% of patients even if you monitor out the 30 days. So that was kind of what we suspected and we're able to show that and kind of legitimize for us that we were doing the right thing, not only from a patient care perspective, because ultimately from a patient care perspective, we firmly believe that long-term monitoring is gonna detect more, but also from a Medicare cost perspective. So I hope this was helpful. I think we're right on time here. I'm gonna leave us with the rest of the time to ask any questions of the attendees. Joe, maybe I'll have you moderate that. Yeah. So thank you so much, Dr. Schaffman. That was phenomenal. And just the massive undertaking that it takes to put together a program that that broad in the name of patient care, I think what you guys have achieved is fantastic. I like your look at it from the clinical and the financial perspective as well, but there's certainly some operational components that I'd like to ask about before I do, because I've got one question, but before I even ask that, I wanna remind everybody that now is Q&A time. So down at the bottom of your screen, again, you do have a button that says Q&A. Please feel free to submit your questions through there. I will monitor those and make sure that they get asked. But I wanna understand just from an operational perspective, what was the biggest hurdle that you guys had to, or some of the challenges that you had to overcome and hurdles you had to overcome to put this together, especially because you are working interdepartmentally? Would love to hear that. Sure. That's a great question, Joe. I think we're actually extremely fortunate because our neurology team and us had already really good relationship to begin with. And we both, after interpreting the trials at the time, felt that this made sense for our patients. But number one is getting agreement between both neurology and the electrophysiologist or cardiologist, whoever's gonna be implanting these, that this is the right thing for your patient. So that's number one. You gotta both believe that's the right thing. If you do believe that's the right thing, then how do you make sure that you and other people in the department also believe in the right thing? And how do you standardize the protocol that every time a patient with cryptogenic stroke comes in, that at least the question is asked, are they a candidate for this? And so we're very highly dependent on neurology making those referrals to us. We don't see cryptogenic stroke patients unless they're referred to us by the neurology team. And so that was something that I think would be a challenge across hospital systems to make sure that both parties believe in that. And I think most now do with all the data that's been coming out in the last eight years since Crystal AF. And then you have to be able to deal with all the information that's coming in. And I think a major challenge is getting a monitor team together. Again, I think it'll be very difficult for one physician to be able to get through all the monitors by themselves with all the raw data. You really need hospital support and administrative support to be able to develop or fund a monitor team to be able to screen all that information that's coming through. And so I think once you have those two criteria, I would say, then the implant is not the issue. It's really the follow-up and making sure that you have a protocol that once you have the device implanted, that you know how to deal with the information. And you wanna make sure you also deal with the information appropriately, meaning that you can't just be looking at these weeks after they're downloaded because if somebody is having AFib or bad arrhythmias, you gotta be able to deal with them right away. Yeah, that's really helpful. I wanna remind everybody again, down at the bottom, the Q&A button, feel free to click that to chime in. We have one question here about your cost analysis, and it had to do with you taking a look at it from, I think, more of a societal level or kind of Medicare-based level, but what are your plans to evaluate cost-effectiveness of the strategy more locally at your health system? Yeah, that's actually a great question. And a couple months ago, one of our teams contacted us as well to see if we can apply this strategy to our own hospital costs. See, it's difficult to do this when you're trying to apply this on a national level because hospital systems vary by regions in terms of what their reimbursements are for the devices. And so we needed a standard kind of Medicare cost for us to be able to do a fair comparison. I think it's important that you look at your own hospital systems and see whether that makes sense as well based on what it would cost your hospital for these devices. The thing that you have to be careful with though is also if you don't implant prior to discharge, how many people are you gonna lose to follow-up and not have implanted again? If you look at some of the data that's published on this, it's a pretty significant amount of patients that do not come back for longer-term monitoring. So then you gotta look at, then how do you do the cost analysis for stroke that could have happened because the patient didn't follow up? And is that truly the best way of monitoring your patient long-term? So I think that's an important analysis. Hopefully we'll have some more data from our standpoint for our hospital system. And we have a large hospital system now, especially if we're gonna be also looking at our integration too with Beaumont Health too, so that they're kind of looking at their area and their reimbursement. So it's something that, this kind of strategy, actually this concept model that we have, you can apply that to a lot of different clinical strategies. How much would it cost to do X first versus doing Y first and then X and everybody else that didn't get the diagnosed with the initial Y approach. And so you can apply that, not just just scriptogenic stroke, but to many different clinical strategies. Thank you for that. We have even a slightly more specific question that's come in as kind of a follow-up to that. That is the use of standard monitoring either singularly or repeatedly, typically as a sensitivity of about one to 23% for AFib detection versus with an ICM, it's about 99% sensitive. And how does that impact your cost analysis? And was that taken into consideration? Yeah, absolutely. So what you have to remember with this is, the reason the sensitivity is lower with those is because in that time period, you may not have had AFib, but if you had done a 24-hour monitor on day two, when they had AFib, you would have picked it up. So it's not the test itself that's not gonna pick up. In other words, if you have AFib on a Holter monitor, you're gonna see AFib on a Holter monitor. The question is, did you wear the monitor long enough to be able to detect the atrial fibrillation? So it's not the test that's bad. I mean, there's obviously some potential misinterpretation of an arrhythmia on a monitor, but that misinterpretation can also happen on a link when they're looking at that. So we looked at the total diagnosis of those patients had we put on, it was actually a pretty good strategy to use because we use the link system over the first two weeks and the first 30 days, right? If you had had an MCOT monitor, that rhythm strip is gonna detect atrial fibrillation, not too unsimilar to the way a link would detect atrial fibrillation. And the same with the Xeo, it's continuous monitoring. So I hope I answered the question, but I don't think the quality of the test is that much different. It's more of the length of time that you were at the test and whether you haven't had the arrhythmia at the time that you were in the test. Yeah, I think that makes perfect sense. And I appreciate that clarification. I have one more question that's in the portal and that's it. So please everybody at the bottom of your screen, Q&A, because this is the last one I've got. And the question is essentially about what is the biggest benefit to your patients by creating this level of standardization? How are you benefiting the patient? Sure, that's a great question. I mean, that's our goal, right? I mean, our initial goal was benefiting the patient upfront. That was why we decided to move forward with this because, and we feel we benefit them in, number one, because we're giving them the longest monitoring and the best monitoring in terms of a high-risk population, right? So we know from these trials that 30% of these posts, a third of these patients that come in with cryptogenic stroke are gonna have atrial fibrillation detected. So that's number one. I mean, that's our biggest benefit. Number two, I think our patients appreciate, for us at least, because we have implemented such a protocol, they get this done before they leave the hospital, a majority of cases, and they don't have to come back, travel. You know, we have patients coming from all over West Michigan and they have an education given to them. They feel like somebody is gonna be watching them. They have their monitor set in place. They have education done right before they leave. And if they have an arrhythmia, they're automatically plugged right in to our AFib clinic, as I mentioned to you, within the 48 to 72 hours. And then their arrhythmia and atrial fibrillation is taken care of and they're plugged in and assigned to an electrophysiologist at that point, usually the one that implanted their link. So I think from a patient standpoint, you have number one, detection, number two, coordination of care between the neurologist and the electrophysiologist, and three is, I think, ease of the monitoring system. Yeah. That access and the reduction of the burden on the patient to come back is just huge and get them while they're really feeling the severity of what could be. So I think that's fantastic. I don't have any other questions that have come through at this time. So if you have any parting words, Dr. Shelfoon, things to share with the group? Yeah, sure. I just think, again, this is a team sport. I think, I don't know how many times I can say that, but neurology for us has been a wonderful relationship and not just the cryptogenic stroke program, it's actually that heart-brain team that was really driven by neurology and the structural and the cardiology teams all together there. That is a wonderful testament of what can happen with multidisciplinary care of patients. And standardization, I think, is important and making sure that you have the appropriate support to deal with massive amount of information so you can treat the patients appropriately. And at the end of the day, that's what we're all here for, is to treat the patients. And again, I would say I encourage everybody to kind of look back and do cost analyses for yourselves and your hospital systems and see what strategies work for you, but make sure to also incorporate attrition rates of patient follow-ups and cost of strokes down the road from that, and also outpatient cost implantation. So that will be my final words. Well, I greatly appreciate it. Again, we will post the slides again in the chat, so we'll get that up one more time. So anybody who hasn't downloaded the slides, look for that in the next minute or so before we close out the webinar. And then we will also send a link to those, when we send a link to the recording, to all of the folks that have registered for this webinar. So a lot of fun things going in the chat there. Dr. Shelfoon, thanks so much for spending time with us today. Thanks for sharing your story at Spectrum Health. We greatly appreciate it and look forward to seeing you again at a MedAxium meeting or on another MedAxium webinar. Folks are now typing into the Q&A, thank you, instead of actual questions. So they appreciate, again, the communication and the education today. So thank you very much. And everybody, this will conclude today's webinar. We look forward to seeing you on future webinars and at an upcoming MedAxium meeting. Thank you so much. Have a great day. Thank you, everybody.

atrial fibrillation

stroke patients

cryptogenic stroke

intracardiac monitoring

multidisciplinary approach

CRYSTAL-AF trial

monitoring options

implantable loop monitors

cost-effectiveness