Hi everyone, welcome to today's webinar on ischemic stroke, improving efficiency and outcomes through neurology and EP collaboration. We are still waiting for some folks to log on. I see that's going to happen pretty actively here over the next minute or two. So we will wait and then we will get started with the webinar in just another minute or two. Thanks for everybody logging on to the webinar. We will begin the webinar in about one minute. Okay, well thanks everybody. Appreciate your patience, while we begin the webinar here today. My name is Joe Sass and I'll be your moderator for today's webinar on Ischemic Stroke, Improving Efficiency and Outcomes Through Neurology and Electrophysiology Collaboration. Our two presenters today are Dr. Salman Azhar and he is the Vice Chair of Neurology and the Director of the Comprehensive Stroke Center at Lenox Hill Hospital, which is a part of Northwell Health. There's more, of course, underneath his bio and we're going to allow you to read that. And there is plenty that Dr. Azhar has done from a research perspective and from a service perspective inside of his healthcare community. And so we are very grateful to have him here today as we are Dr. Najeeb Chalfoon. Dr. Chalfoon is a cardiac electrophysiologist at Corwell Health in Michigan and he's the Program Director Cardiology Fellowship for Corwell Health and for Michigan State University. Also a number of research articles relevant to his field, as well as a number of service activities inside of Corwell Health and across many professional societies. So we're grateful to have both of these speakers here with us today. And so thank you both, gentlemen, for being a part of this webinar and lending your expertise. I also want to take just a brief moment to thank Medtronic for providing a grant that enabled us to conduct this webinar today. Now, as we get started, I want to make sure that everybody knows how to interact with us through the webinar. Number one is that there is a chat function and that's on the bottom left hand side of your screen and you're able to use that to access the slides. It will not be open for chatting amongst participants during this call, but it is a place where throughout the call you will see us put the link to today's slides. We also have a way that you can interact with us and whether you need to ask questions for logistical purposes, for being a part of the webinar, if there's a sound issue or anything like that, or if you have questions to ask the presenters themselves, we do have a Q&A button at the lower center right side of your screen. So that's the easiest way for you to interact with us today. And again, we're really grateful to have you here. So moving forward, I'd like to turn it over to Dr. Azhar and what we'll do is have him present really from the neurology perspective and then Dr. Shalfoon will present from the EP perspective. And when I talk about those, they're certainly not dichotomous. They've created heart brain teams inside of their organization. So two different organizations that have bridged the gap between neurology and electrophysiology for the betterment of stroke patients. So that's how we're going to go today is we first Dr. Azhar then Dr. Shalfoon will do some Q&A and then we will take audience Q&A as well. So please feel free to enter them anytime inside of that Q&A box. With that, I'll turn it over to you, Dr. Azhar. Thank you for being here with us. Great. Thank you, Joe. And thank you to MedAxiom for inviting Dr. Shalfoon and myself for this. And I look forward to not only showing you some of my data and some slides, but also answering your questions. Next. So I have, I'm a consultant and speak, I speak for Medtronic and that's my only disclosure. Next please. This I think is a really, I think it encapsulates sort of why we do this. And as this is actually put a slide that was actually presented first by a cardiologist, an EP cardiologist at Lenox Hill. And the only thing more devastating than a stroke is a second stroke that could have been prevented. Next. That creates a tremendous amount of disability and everything that we do in stroke is to try and prevent, not treat the first stroke and prevent the second stroke. This is an algorithm from the 2021 guidelines and the AHA guidelines on, on secondary stroke diagnostics and prevention in terms of inpatients. And you can see here that we're looking at long-term cardiac monitoring as a class 2A evidence. But really, what we want to talk about is how do we get from the point of the initial CTs and the initial scans and the initial transthoracic echoes to a place of much more sophistication and understanding why the patient has a stroke. Next. So our objectives today to understand the current state of secondary stroke prevention, how it needs to evolve, and why does it matter? We're going to really focus on cryptogenic stroke and to some degree atrial fibrillation detection and treatment. But as you can see, when we think about secondary stroke prevention, we're not just looking at one aspect of it. We're looking at multiple aspects of the, of the pathology that might be leading to whether it be clots coming from the heart, the endothelial interactions, and of course, how do we actually reduce our risk factors and something that I, that we term as residual risk reduction, which becomes very important in, in secondary stroke prevention. Suffice it to say, secondary stroke prevention is perhaps the area where we all fall down. Across the board, across this country, we can do a better job at preventing the second stroke from happening. We're very good at treating the stroke when it happens. And that first hour, that first 24 hours of stroke treatment is really, has morphed into a very evolved state in most places throughout this country with the presence of thrombolytics and thrombectomies and other treatments we have, but really where we don't do as far as well as preventing that second event. Next slide. Okay. So let's talk a little bit about the different types of stroke. Most of our strokes, fully 88% of our strokes are ischemic in nature. The rest are subarachnoids and intracerebral hemorrhage. We then have most of those ischemic strokes are actually non-Lacuna, so non-small vessel. And then only about 23% of those Lacuna strokes, 23% of all ischemic strokes are Lacuna. I want to stop there and say that even the Lacuna strokes, if the size of the Lacuna or the size of the actual small stroke is greater than five millimeters, there's up to 40% of those strokes can be due to embolic disease. So Lacuna strokes by itself do not prevent you from working up for embolic disease. But let's just focus on the non-Lacuna ischemic strokes and fully 45% of them are cryptogenic. So the patient will leave the hospital without us knowing why they actually had that stroke. And typically that's because there's no large vessel lesion and on, you know, testing of the heart, we don't find any obvious cardioembolic source. But again, that's, if we just stopped there, then we would basically be letting a large chunk of our ischemic stroke patients leave without a plan to try and figure out why, how, and why we could prevent a second stroke. Out of those cryptogenic strokes, 50% meet ESUS criteria. And we'll get into that, but basically ESUS stands for embolic stroke of undetermined source. And patients who have this embolic looking pattern on imaging should be worked up further for cardioembolic and other causes. Next slide. So fully 250,000 patients are put, you know, can be cryptogenic every year, right? So if you look at the risk of recurrent strokes now, all stroke, all comers, that starts at about 5% in the first year and triples by 10 years to 15%. If you look at it based on subset of strokes, the typing of strokes, next slide, next slide. You'll see that we're sitting at about 15% for small vessel, large vessel, and cardioembolic and cryptogenic strokes had a much higher incidence of a secondary stroke. Now, one of the important things I want to make here is that just because someone had a small vessel stroke, we know from a study that we'll get into only a little bit called stroke AF, your next stroke doesn't have to be also from small vessels. It may actually be from atrial fibrillation. So understanding not just why the person had a stroke now, but also what are their risk factors that may evolve, or they may evolve in these risk factors as they progress after their stroke is important. Next slide. So this is the ACEs criteria. And basically I'll summarize it by saying no large vessel lesion, such as a carotid, no obvious cardioembolic source, such as atrial fibrillation identified, the stroke looks non-Lacuna on MRI or CT, and no other cause identified, such as hypocoagulant disease, malignancy, if we're looking for that, infections, things like that. All four criteria must be present to be designated a cryptogenic stroke. If you do have a cryptogenic stroke, then these are the patients that I want to focus on today for the rest of the talk. Next slide. So one of the things that I get always asked by my cardiology colleagues is, well, look, you're telling me this patient has an ESUS stroke, an embolic stroke, looks embolic on the MRI. Why not just start them on anticoagulation? Because you're pretty sure that these are going to be coming from some, most likely atrial fibrillation that we just haven't discovered yet. So why not treat early and proactively? Well, we have several studies, as I'm sure you're all familiar with, including the DOAC studies, NAVIGATE using rivaroxaban, RESPECT using dabigatran, and of course, Arcadia using apixaban. And I'm just presenting two here. Both NAVIGATE and RESPECT showed either negative, in the case of rivaroxaban, increased bleeding, or in the case of RESPECT and Arcadia, failing to meet primary outcomes. So no benefit to just start patients on anticoagulation, even if the MRI shows an embolic stroke. And I want to be very clear there. And this data, which is the most recently present in the DOACs, we knew this back almost more than a decade ago when they were at the Warfarin versus aspirin study, where there was no benefit to Warfarin. So we know we have multiple studies showing that even if the stroke looks embolic, there is no indication to start these patients in anticoagulation prior to actually diagnosing atrial fibrillation in these patients. Next slide. So that's where we come to the CRYSTAL-AF study. Next slide. And CRYSTAL-AF study basically looked at this population of cryptogenic strokes and the implantable cardiac monitors or loop recorders in these patients during the hospitalization, and then followed them out for a full three years. And looking at this, if you look at this at the 36-month point, you see that using a loop recorder versus using standard medical care, which may have been a holter, event monitors, EKGs, or even at different times throughout that three years, you really understand the impact that a loop recorder has in terms of diagnosing AFib in this population. And fully up to nine-fold increase in the likelihood of diagnosing AFib in this population, which remember, if you go by Chad's VASC, you know that this patient had already had a stroke, they were cryptogenic, so we didn't know why they had a stroke. And so diagnosing AFib in this population becomes incredibly important, because if you diagnose AFib, you can treat it and prevent the second stroke. So one of the reasons why I think this is an important study, and Dr. Shafoom will get into this as well, is that this continuous monitoring, and monitoring from the hospital itself, so there's no gap between stroke, getting the patient either on telemetry, and then getting the implantable loop, and then leaving the hospital. So you have continuous monitoring ongoing. This is what allows us to really not only pick up the likelihood of AFib presenting itself, and then treat that AFib. So next slide. And you see here in terms of the three-year follow-up, six months, it was an 8.9% versus about 1.5%, and at 24 months, a 21.5% likelihood of diagnosing atrial fibrillation. So significant difference in terms of our sensitivity and specificity in terms of picking up this population, who if we don't treat with anticoagulation after the diagnosis of AFib, would have gone on to have another stroke. Next slide. So if you look at all of the studies done, and this includes, this does not include Stroke-F, which we'll get into, but Crystal-AF and Find-AF, and multiple other papers reported in terms of observational studies, using an implantable cardiac monitor, which gives you continuous recording, is by far superior to conventional cardiac monitoring in terms of diagnosing AFib in this cryptogenic stroke population. Next slide. And of course, in these patients, there was an increased incidence of anticoagulant initiation. And the next slide, you'll see that in the same meta-analysis, a significant risk reduction of stroke and the relative risk, significant relative risk reduction in these patients. So we know that by doing this in this cryptogenic stroke population, we are making a dent in terms of the likelihood of recurrent stroke. And patients who underwent this kind of monitoring, long-term monitoring, had a 55% decreased risk of recurrent stroke when compared to conventional cardiac monitoring. Incredibly important to understand this because the, it is important to understand when, you know, why we sort of chose this process and really work with our EP colleagues to really develop a pathway, not just that would help, you know, make sure the loop was implanted, but then also a pathway, and we'll get into this, to make sure when AFib is diagnosed, we are informed about it, and there's a collaborative decision made about anticoagulation, and we can then continue to follow the patient. Next slide. So that brings the idea of stroke care pathways. And again, think about it. You know, this is not something that we find works if you do it in an ad hoc manner. Creating a pathway that allows us to really make sure that the cryptogenic diagnosis is made quickly, the loop is implanted prior to discharge, the patient is followed up post-discharge by EP or cardiology and by neurology or stroke, and that there's a communication process, a bidirectional communication process that allows us to communicate with each other if AFib is diagnosed and then to treat it. All of those things have to be part of our pathway. And so we're going to talk about, spend the rest of the time here talking about that. Next slide. So post-stroke workflow protocols vary significantly. We know this. Only 20% or less than 20% of patients actually receive a cardiology consultation during their index stroke. Next slide. All those patients who start with a short-term monitor, only a small fraction go on to receive an implantable cardiac monitor, and I certainly see this in my patients. We have patients who, for a multitude of reasons, refuse to get an implantable cardiac monitor. In our population, it's a very small, in our centers, it's very small, but it does occur. And when we then try and use a ZEO patch or an MCOT patch and then get them to start to get a loop implanted, a lot of those patients don't end up getting loop implants either because of insurance difficulties or because the urgency in that patient to try and get their stroke worked up is less intense. And so they oftentimes will prefer to sort of put off monitoring. Also, a lot of times those patients are oftentimes advised by their internists or other cardiologists to just wait and just do multiple cardiac monitors, short-term cardiac monitors. So really only less than 5% of our patients who don't get an implantable cardiac monitor during hospitalization end up getting one after the fact. Next slide. So this is the real-world results of gapless monitoring for AFib, and you see that basically in week one, only a small number of patients are diagnosed. And even if you look at week four, very small numbers, and only 5% of our patients would have a detection of AFib in cryptogenic stroke population. So even if you put a back-to-back, no gap, two ZEO patches or two MCOT patches or a four-week event monitor, you're still only going to be picking up a small number of AFib. So the second point I want to make, the first point is we don't want a gap because if you have a gap and you have an event, you're not going to make that diagnosis and the patient can go on and have a stroke because they're not on anticoagulation. The second point I want to make is we want long-term monitoring, continuous monitoring, because only then are we likely to pick up that event of atrial fibrillation, pick it up, learn about it quickly enough, and treat it quickly enough. And again, in this study, as you can see from Milstein, patients had a CHAD-VASc of between 3.5 to 5-plus, and clearly would have benefited from anticoagulation once AFib was diagnosed. Next slide. So time to AF diagnosis becomes important. As you can see, if you have zero monitors, the time is 190. If you have a monitor like a ZEO patch or a MCOT, and then you use long-term monitoring, if you go straight to long-term monitoring, it's 194 days. If you have one or two short-term monitors, it can be delayed to as long as a year out. So clearly, what that tells me is that we are missing AFib events that are happening, potentially, because, of course, someone gets an MCOT, then we wait for the reading on that, then we get a loop implanted, you're going to have gaps, and you're also going to delay diagnosis, which means potentially that the patient can slip through our fingers and end up having a stroke in the interim, which, of course, sort of defeats the entire purpose of what we're trying to do, which is prevent that second stroke. Next slide. So compared to external cardiac monitoring, you get a faster time to AF diagnosis, you get a faster time to oral anticoagulant initiation, reduced readmissions because the patients don't have another stroke, which is incredibly important, and, of course, reduced rate of mortality. And what's not mentioned here is reduced rate of disability. Next slide. So I've already talked about this, but gapless monitoring, greater AF detection, higher patient satisfaction, oftentimes lower cost to the patient because they're not having to pay the co-pay for both the short-term monitors and the implantable monitor. If we implant inpatient, obviously, they don't have to have a co-pay with that. Patient compliance is suboptimal in these patients, losing patients to short-term monitors, delays in AF detection, and, of course, we talked about the cost effectiveness. Next slide. So I'm going to now give you three different sort of case scenarios because Northwell is, just to sort of frame it, Northwell is a large hospital system in the East Coast. We have about 23 hospitals, soon to be 30 hospitals in our system. I've chosen two of our comprehensives and one of our thrombectomy centers. The comprehensives are academic centers, and the thrombectomy center is a community center. And you'll see a hospital, and you'll see there's a difference. And so we want to be able to sort of think about how do our protocols need to change depending on the hospital environment or the resource environment that you live in. So Lenox Hill Hospital, which is where I'm based, this is what happens. A patient comes in with a stroke, an ischemic stroke. Very quickly, we do initial CT, CT, and CT perfusion in the emergency room. We get a, you know, we'll oftentimes, if a stroke diagnosis is made either by clinical or by CT diagnosis, we'll know if this patient has an embolic looking event. And we'll know by the time the ER process is finished, whether they have a large vessel lesion or not, or whether this is a small vessel stroke. We'll then get an MRI very quickly. And again, we'll have a confirmation that this is an ESUS looking stroke. In our site, because of our collaboration with cardiology and EP, we're oftentimes able to tell our cardiology and especially our ultrasonographers that we want a TE and TTE together. This is, I know, not typical in a lot of places across the country, but we're able to get that done simultaneously. So we're able to look at the left atrium. As all of you know, a transthoracic echo doesn't really give us a lot of evidence in terms of cardioembolic sources because it doesn't get to look at the atrium well. Of course, we can look for PFOs, we can look with bubble studies, we can look at the valves, but we're able to do both T and T at the same time. And that actually rapidly sort of really enhances our process. So within a couple of days, we've been able to understand that the patient does not have a clot sitting in the atrium or left ventricle. We know that they don't have any arrhythmia on the inpatient monitoring, and we know they don't have a large vessel stroke. So then in this cryptogenic diagnosis, we make sure there's no contraindication, not only to oral anticoagulants, but also of course, if they're not able to tolerate long-term anticoagulants, could they tolerate a Watchman? If they have a PFO, we'll look for a lower extremity venous ultrasound. We'll get consent for LINC very early in these patients, and basically the EPPs do that. The LINC is actually implanted at bedside in the stroke unit. That's incredibly important because it doesn't waste EP lab space or EP recovery room space. And we're able to do this in a sterile manner at bedside. That's been important for patient satisfaction, but also from a neurologist perspective, it means that my patient doesn't have to leave the stroke unit where they're being watched neurologically with neurochecks and go down and get a procedure when I prefer them to be continually be monitored in the stroke unit. Not absolutely essential, but it certainly enhances patient satisfaction. This is followed by patient education, both by my team and the EP team, and then discharge, daily monitoring by the device clinic, as you see. If there is an AFib event detected, there's immediate discussion between the EP team and my team and we make a collective decision and oral anticoagulant is initiated. As you see here, we have a 93% LINC implantation rate in our cryptogenic stroke population. So we're doing incredibly well in this part. This process has really worked out well. Next slide. If I now look at this spot, this is another hospital, Staten Island University Hospital. Again, 94% LINC implantation, but here are some areas where there is some slowing down of the process, which may delay length of stay. So here's where we're working with our cardiology colleagues to really look for improving this. And again, we do this in fairly rapid fashion, but here at Staten Island University Hospital, we first have to get a negative TTE, a negative vascular imaging before I can get a TE if it's indicated. We'll also get an EP consult at that time. And basically, the TE takes longer to get here. So sometimes the LINC may be delayed because I want to check, make sure there's no clot sitting in the heart before so I can decide on anticoagulation in real time. Once we make a decision on LINC, again, that happens very quickly. It's either monitored in the EP, but also now we are moving towards getting this implanted in the stroke unit. And again, by far, if you're able to do that, I would really strongly recommend implanting these patients in the stroke unit. It tends to be much easier, much less, not as resource intensive. And my EP colleagues feel that it actually works, that it doesn't impair the sterility or the success of the procedure itself. Again, the patient education, the same process. One of the things that we benefit from system-wide is that we have this daily monitoring device, for device is done system-wide. So no one hospital has to be, take on the heavy lifting of this. And a system-wide, we have a device monitoring clinic, which is able to notify our EP docs and then they're able to notify us. And again, cryptogenic stroke volume 149, 94%. So the only improvement we are working on here is how fast we're able to get the patient through this process so we don't delay a discharge. Next slide. So this is actually not Staten Island University Hospital. That's a typo on my part, but it's actually a hospital called, it's a Phelps Hospital, where the EP resources are not as great. We have one EP doc, one EP APP. This is a thrombectomy center with a smaller volume. It's a community hospital. And you can see we only have a 36% link implantation rate here. So what happens here? And this is an example of where, this is an example of where in a different hospital with a different resource ability, we have to think differently. So again, negative TTE, vascular imaging, no contraindication, patient may or may not get a TEE. They do, and lower extremity ultrasound if needed. They get, if the decision is made to implant a link, consent for the link, but because of limited EAP staff, sometimes these implants are deferred to outpatient, to ambulatory. And then as I explained to you, we know what happens here. People don't end up getting these implants and we get a lot of patients who, either because they refuse to, or they don't come back to get the implants, are lost to implant or monitoring follow-up. So here, what we have come up with a strategy, which we have just started to put in place, is that instead of counting on the EP staff to do the implants, we have trained our neurology APPs under the supervision of our EP attending, our EP director, to actually implant these loops in the stroke unit. And by doing so, we feel like we will be able to sort of meet the needs of our population, and again, implant so that we don't, we have a gapless, continuous monitoring process for these patients upon discharge. That becomes very, very important, again, as I've talked about before, in terms of making sure that we are able to make accurate and quick diagnoses of atrial fibrillation and put these patients in the right anticoagulation. But here, obviously, resources made us change our process. We've come up with a fix, and I look forward to this hospital being up in the 80s and 90% implantation rate very quickly. Next slide. So I quickly kind of talked about how you can go about developing the stroke pathway. It is absolutely a collaborative effort with cardiology and neurology, and specifically EP and stroke. Next slide. Okay. Identifying the champions is incredibly important, and not just one champion. You've got to have a champion in both neurology and cardiology who are really going to work on this together and make sure it moves forward. We've got to agree on which patients, the pathway and the education plan, and then communicate and launch a new pathway, and then meet looking at the data of how many patients are slipping through the cracks and how does that impact patient care and how does it impact patients in terms of secondary prevention. Next slide. Okay, so champions, of course, somebody who, you know, it could be somebody who has a lot of authority as an influencer, but actually, it's also somebody who's willing to roll up their sleeves and do the work. And so I think that this could be someone in terms of a neurologist or a cardiologist, but it could also be a stroke project manager or coordinator and a leading EP, APP. And in different systems that I've looked at, it really just takes those two people coming together and really establishing a vested interest and ownership in this process to push it forward. And again, with regular meetings to make sure the process is moving forward. Next slide. So agreeing on the patient's pathway and education plan, I think is pretty straightforward. There are plenty of resources and we can certainly provide them in terms of what our pathways look like and how we do this and when do we do this. But in our center, a decision about ESUS is made very early within the first 24 hours of stroke admission. Assuming they have a non-Lacuna stroke and they don't have a large vessel lesion, we're moving very quickly into this ESUS diagnosis. Obviously, if you discover AFib while they're on telemetry, that changes that. But as you saw, most of the patients who leave the hospital end up being cryptogenic strokes. So we have a very quick process of identifying. And this is probably one of the biggest sticking points is that neurology has to really make this diagnosis of cryptogenic stroke and ESUS stroke very quickly. Next slide. Then cardiology has to have a process by which there's no delay. And our loops get implanted literally the day before discharge, the day of discharge, and then the patient is out of the door. So we have it timed and scheduled in a way that this happens. One quick point, we really try, if we're gonna do a TE and then a loop the same day, we make sure that the loop is consented before the patient gets a sedation for the TE. So that once the TE is done, if that's negative, we can move to a loop recorder very easily. Of course, you don't need to do a TE in every patient, but if you do, get the consent early. Obviously, educating the entire care team, making sure you're not impacting length of stay, but also making sure that you're giving enough time for the patients and their family members to ask questions and understand how this impacts what's happening to them now, but how we can help this prevent a second stroke. And I really talk about this with my patients as this is an early warning system. We are really trying to get a system in place, a device in place, and a monitoring in place. So if something happens such as an AFib episode, we'll pick it up and we'll treat it early. And then of course, leveraging Medtronic's resources here can be very helpful. Next slide. Okay, meeting with the team regularly. This is obviously important. You've got to make sure that what you put in place is still being sustained, and that's by looking at the data. And you'll be able to get this data from Medtronic, but also looking at it from your own EMR. Next slide. Thank you. And I know I spoke fast, but I'll now turn it over to Najeeb. And Najeeb, it's all yours. Thank you, Dr. Azhar. Thank you again, Medaxium and Medtronic for giving us this opportunity. It's always fun to work with Dr. Azhar to talk about something we're both very passionate about. So I'm gonna kind of switch a little bit of gears again and give you the electrophysiologist's point of view and a little bit of how we started our program and then take you a little bit into the outpatient setting and then talk about potentially the cost-effectiveness of different strategies. So next slide, please. So these are my disclosures. I am a consultant and speaking fees for both Medtronic and Atrocure. Next slide, please. So again, we'll take you through our pathway, how kind of we implemented, why we decided to do this, and then talk about some highlights of success factors leading to a good multidisciplinary approach to creating a program on the inpatient and the outpatient side, and then go through the cost-benefit. Next slide, please. So this is really where it started for us. This was back in 2014 when the CRYSTAL-AF trial came out, and it started out literally with a phone call to my friendly neurologist. Again, when Salman was talking about getting physician champions, this was two physicians on both neurology and electrophysiology side that said, oh my gosh, really, this makes a lot of sense for our patients. Let's see if we can work together to implement a program. And I'll show you here, kind of this was our numbers from 2010, 2013, before CRYSTAL-AF came out, how many ICMs we're implanting. And then when this came about for cryptogenic stroke, you can see the volume increased pretty significantly over the next few years to the point where now we have about 900 patients enrolled, and we have an entire ICM clinic staffed by three exercise physiologists. So next slide, please. This is now the current state. As you can see, we're about between 200 to 300 ICMs implanted per year, and our total number is about over 900 in general following these patients. Based on that initial conversation we had over coffee, I still remember this after that initial paper, and it's developed into this program that we feel really benefits our patients in multiple ways, many of which Dr. Azhar has already gone over. Next slide, please. So just remember that as you are having your physician champions kind of think about developing these programs, it's not just EP and it's not just neurology. It's a really multidisciplinary approach. And as you're developing both the neuro EP side, of course, at the crux, also think about triaging it to an entire AFib clinic, which is what we developed over the years. And that includes a high-risk medication clinic that's gonna deal with managing your anticoagulation and following the labs that need to be done for DOACs, having a structural heart team potentially that's gonna be taking care of your appendage occlusion devices and your cardiovascular imaging team that needs to image your TEEs, your emergency department that's gonna need to funnel in those patients, and of course, make sure they know about the protocol so they can notify the neurologist and not just send them home if they're having a TIA. So it's a collaborative effort to create this. And it's something, it sounds overwhelming at first, but it really is if you start with the core and you have your physician champions and your staff champions, you can get these things built together and really create a program that can help your patients. Next slide, please. So again, you both heard us say the big thing is to make sure you engage the specialties at hand. So neurology, cardiology, of course, but also don't forget hospitalists. Hospitalists sometimes in many, especially in smaller hospitals, they may not have neurology team or cardiology. So make sure they're aware, especially if you're part of a multi-system, multi-hospital system. You have to have your leadership on board. Fortunately, we were very fortunate to both have our leadership and actually we own a, we're part of a insurance system, Priority Health at the time, we engaged them as well. When we started this program to say, hey, what do you think about this? Is this something that's gonna be potentially cost-effective for us to offer this to our patients? Have a standardized approach. I think you heard us both say, standardization is really important so that especially if you have multiple different hospitals in your system, that they're all following the same steps to try to get you maximum efficiency and the less variation, the more efficacy you'll have. And you have to educate not only your staff, but of course the patients and their families and we'll get into that a little bit. Next slide, please. So once you create the program, you have to be able to manage it on the inpatient setting and the outpatient setting. What is critical to us, the only way we're able to manage this volume of patients, I mentioned over 900 patients, is we have these standardized protocols, but we also have a monitoring team. We have an entire monitoring team that is able to screen all the alerts that come through. They screen them. They then alert the physicians that can handle them. We've developed this referral pattern between on the inpatient service, of course, through our neurology and hospitals, but also on the outpatient. Cardiologists, neurologists, how are they gonna get to your electrophysiologist to implant the loops as outpatients? You have to always have the patients really educated about being able to send remotes. So patient compliance is really important for follow-up. You can implant all the loops you want, but if the patients are not following up with what you need them to do, that's not gonna be a successful program. And of course, then after you find AFib, you have to be able to take care of those patients with AFib, so you have to have an AFib clinic or some kind of AFib program to plug in those patients. Next slide, please. So this is just our protocol. It doesn't have to be your protocol. You have to come up with a protocol that works for you and your neurologist. Dr. Azhar showed you at his hospital, there's different kind of processes to get to it. Our basic protocol is basically, neurology has to call it an ESUS, right? And that's important, right? Because we have to have an expert that says, okay, this is ESUS. And then that automatically activates for us a consult by our electrophysiology APPs. We really use our mid-level providers as they can see all the consults as inpatients. And actually the implanted physician will just meet them, the patients on their way to discharge. Really, we try to maximize telemetry monitoring while they're in-house, because often we found AFib during those few days. So we wait until the day of discharge to implant those patients. We tend to do them in the prep recovery on their way out. I think it's wonderful to be able to do it at the bedside as well. If you can do that, we're just starting to have our APPs as well, learn to do it and implant instead of your physician. So whatever works for your team, just make sure you have a program that's standardized and specialized for that hospital. And again, that you're meeting on a regular basis to see what works. That protocol that I'm showing you here has been modified, I don't know, 50 times probably since we started this 10 years ago. And that's because of continuous communication between ourselves and our neurology team to see what works. Are we implanting too many? Are we not implanting enough? In terms of patient selection, we tweak it as the data comes along and that's how we come up with these. Next slide, please. So once the patient has been deemed to be a candidate for a loop recorder, whether it be on the inpatient, through our APP team, on the outpatient, it's also through our APP teams that sees the patients first, then they trigger an ICM request and then our teams will be able to see that ICM request through our various messagings, whether it be electronic or verbal. And then the patient is given a packet and that's really important. So the initial communication happens to the patient. If that patient does not happen to have a packet given, we'll make sure to send them one. And then the process then starts of educating the patient about what's gonna be happening to them. And then we move on with our implant. Next slide, please. So again, the patients need to be educated about why they're having these monitors placed. Sometimes patients come in and they have no idea. And so we have to make sure they understand why this is such an important thing to have. And all the reasons Dr. Azhar mentioned, improved anticoagulation, reduction of stroke down the road, obviously because of detection of atrial fibrillation being so much more improved with loop recorders. They need to know how it's gonna be done and importantly, the expenses. So we actually give them a little pamphlet that actually goes through the expenses and have them call their insurances so they know exactly what they're getting into. We've had some patients that early on when we weren't doing this, they wanted to turn off their monitoring because they found it was actually too expensive for them. So really important to have their patients educated. Next slide, please. And then we give them pamphlets about what they're going to be expecting during their journey through their loop. So they'll get this type of pamphlet. They'll understand that there's going to be a pre-procedure phone call, education post-procedure, a 48-hour phone call, and then maybe they're going to have to come in for a wound check if their wound doesn't look right to them. So we check with them in a week again to see how they're doing. And then what we do in our clinic is every 90-day summary follow-ups or automatic alerts. You can tweak that however you need to between one month to every three months. We have chosen the three months since we have an automatic trigger for any alerts in between. Next slide, please. So the monitoring team is critical. The ICM team is critical. We have wonderful people that are, you know, trained in telemetry reading. Obviously, they're exercise physiologists, and they're monitoring our alerts daily. And if there is anything that's abnormal, that is automatically sent that day as a high alert to the physician through our EPIC system. And then the physician affirms that it is atrial fibrillation. And then importantly now, we've closed the loop again by sending it to our neurologist. So the neurologist is involved, and then we send it in through our AFib clinic. So I think it's important to make sure the neurologist is also involved through this as they're also continuing to care for those patients. And again, you're creating collaboration, and then you're continuing the collaboration, right? So it's important to not only create the program, but to maintain it and nurture that program. And so it all comes down to collaborative effort between your key teams. Next slide, please. So is it cost-effective? And you know, that was one of the questions we had in mind initially when we were doing this. But you have to first understand that the first question you have to ask yourself is, do you believe that this is a better technology for detecting AFib? And when we are showing that all the data is coming out, that at three years, it's 30% versus 3%. How can you not believe that this is a better technology? And so when we said, okay, we're committed to this, then we thought to ourselves, hey, if we were to do just monitors on discharge, and we pick up 5%, 10%, if we're still going to be putting in 90 or 95% of patients in ICM, because we believe it's going to be the next step, isn't that going to be more expensive than to just do the ICM up front? And that was our whole theory behind why we did this so early back in 2014. So next slide, please. So there's been a couple other papers that looked at also kind of cost-effective modeling. This was based, this was done by Sawyer and his team. And they showed about a 31,000 quality of life gain, because they included stroke recurrence, potentially, if you did miss AFib and didn't anticoagulate. And the next slide is our paper, which we published back in 2022. Again, looking at that same concept, what we did is, next slide, please. We went back at all our patients that were implanted with the ICMs prior to discharge, and we looked at the actual detections that we found of atrial fibrillation during that time. And we said, well, what would have been the cost based on that detection of having done just a two-week monitor? How many patients would we have missed and still had to do an ICM? Same concept for 30 days. And then what would have been for ICM up front? So next slide. And what we found was something that confirmed our suspicions. We found that on those ICMs and all those patients that were that were implanted, at two weeks, it was, you picked up about 7% of patients. So that means 93% of patients were still needing to have an ICM. At 30 days, it was 9%. And at six months, it was 17%. So had you done a 30-day MCOT, for example, you still would have had to put in 90% in patients, an ICM. And what that cost translated to, we did Medicare cost simulation. And what that ended up translating to was actually a cost reduction, if you went into ICM first, of almost about $4,000 for Medicare patients, payments per patient, and about $1,500 actually to the patient in terms of co-pays, had they had to get this done as an outpatient. It's actually more expensive to get it done as an outpatient. So we also said, well, what if that's just our data? Let's just compare it to also two other major randomized trials that were published, both the PERDIEM trial and the STROKE-AF trial. And interesting, look what we have here, almost the same exact numbers, almost a $4,000 savings, if we, based on their data, if we did the same cost modeling to Medicare, and then about $1,500 saved to the patient. Next slide, please. And then it's nice to see that, so this is about the same thing here, about a 50% reduction for the patient, about $1,500 cost savings, which goes from about $3,000 down to $1,500 for the patient in terms of out-of-pocket. Next slide. And nice to see that other hospitals too have done kind of similar things. Now they looked at just modeling what would happen if you just did the telemetry and watched them only for a couple days in the hospital and then put in an ICM, and they found about a $1,500 change and savings to the hospital as opposed to ICM first. Next slide, please. So that's it for me. I'm going to hand it over back to Joe. Thanks to you both. That was just such great content, and I know it probably has spurred a lot of audience questions as well. So what I'd like to do, because we have about 10, you know, 13 minutes left, I'd love to reintroduce everybody to the Q&A button at the bottom of the screen, and if you click that, you can feel free to type in any of your questions and move forward from there. I will wait as those come in. I do have a couple of questions, you know, kind of of my own, and Dr. Azhar, your first slide, or one of your first slides, had something of the effect of, you know, the worst stroke is the second stroke that could have been prevented, or the most devastating one is the one that we could have prevented. I want to ask you about secondary stroke and what that, you know, the impact that that stroke and what that, you know, if we prevent that, what does that really mean for patient outcomes in the long term? What does that mean for kind of population health of the community? Like, why is this so secondary stroke so critical from a larger perspective other than, of course, the patient having that second stroke? What are the wider implications? You're on mute. All good. Yeah, so thank you for the question, and the bottom line here is that the second stroke, what does it do for the community, public health? You know, there's a tremendous increase in disability with a second stroke, right? So that is dollars and resources, both personal resources and financial resources that are spent by a public health system and by our communities. Obviously, you can also think of a second stroke as a reason why people stop working if they've been able to get through the first stroke. So a lot of people stop working in that process. So, and then, of course, come all of the additional factors in terms of rehab time, spending time in rehab centers, nursing homes, all of that really. So it's a huge financial, but really sort of social impact on our communities, right? But think about it, right? 30%, if we say we did nothing else, 30% of our strokes, we are telling the patient, you're going to leave the hospital without knowing why you had a stroke. And if we didn't do anything else, like the loop, we would be telling them, and we don't know why, and we're not going to study you anymore to find out why. So I bring it down to that individual person who's, you know, might be somebody's father, somebody's brother, somebody's mother, somebody's sister, somebody's wife. 30% of our population, we tell them, if you don't do this, we don't know why it happened, but it happened. In 2024, tell me what other disease do we allow that to happen in, right? Think about that. A patient had a myocardial infarction and you told them, oh, I don't know why it happened. It just happened, right? So it's understanding that our work doesn't end at the hospital discharge door. That's really the, just the second phase of this process. And we need to keep looking and being proactive because of the personal impact and the community impact and the public health impact of a second stroke. Yeah. Yeah. That's, that's that's such a great point. And I really, that slide resonated with me, but I wouldn't want to be that patient. That's for sure. So, and as you think about putting that in and then Dr. Shalfoon, you, you know, you put in ICMs for a number of reasons, but when you get to a stroke patient and cryptogenic stroke and you start to, you know, use that as ICMs, I'm curious about, do you feel that that patient needs to be monitored longer than just a suspected AFib? And, you know, would you ever go to multiple ICMs with a stroke patient or how do you view the duration of diagnostics with a stroke patient versus a non-stroke patient? Yeah, that's a great question, Joe. You know, nowadays our ICMs are lasting about four years. That's a pretty decent time of monitoring post. We as a group have not re-implanted for, after the four-year monitoring typically, because most of the time, if you're going to have that, like we, you know, if you look at the data at the three-year mark, you got, you know, almost over 30% of patients that if they had AFib, they'll show up. Now, listen, with AFib, unfortunately, I feel like if we all age enough, we're all going to get AFib, but just, you know, it doesn't mean just because they don't have it in the four years of monitoring, they're not going to get it again 10 years, 20 years from down the line. But in terms of, you know, that immediate reason for the stroke, we feel that most of the time, that four-year mark, that one loop recorder is usually pretty good. Salman, I don't know what your practice has been. Unless somebody is, I would think, is a super high-risk patient, in those patients, we would potentially re-implant, but that would be the smaller of the group of patients. I agree with you, Dr. Shauf, and I think we don't typically re-implant. There are some patients who, you know, potentially, I think we haven't had any events, we may want to re-implant because of what their heart looks like, what their other risk factors are, and they have congestive heart failure, sleep apnea, so their profile is much more risky. But I would say that, I think the other point here is that we also know that even if our stroke patients are strokes caused by small blood vessels or large vessels, so not cryptogenic, but small vessel, large vessel stroke, the most recent study, Stroke AF, showed that a large number, a much higher number of those patients than we previously thought, actually develop AFib after the fact in those four years, or typically in the three years, the study was a three-year study. So, we know that not only is AFib a reason for a stroke, but AFib may be caused, a stroke may be a risk factor for AFib. So, you've got to look at this, and oftentimes that nuance at AFib is then the cause of the stroke, or the second stroke. Yeah, and Joe, what I'll also add to this too, and just remember that if you do catch AFib, right, then actually that becomes a management tool for AF. So, loop, you know, ICMs are currently indicated for management of AFib, and so that's, and in that case, if we do catch AF, we will offer some patients the opportunity to have that continued so we can continue to manage their atrial fibrillation, especially if they get ablated down the road, what have you. We also, remember, this picks up bradycardias and all kinds of other arrhythmias. So, there's a lot more information you catch from having the ICM in place. Yeah, well, I have a question that's come in, and before I ask it, I'll prompt everybody else again. Feel free to use the Q&A button and submit a question. I believe that, although it was not specifically directed to either of you, I believe this will fall into your category, Dr. Shelfoon, and it says, did you look into the contribution margin of the index admission with the ICM versus not with the ICM? Some EPs have argued it's not cost-effective, although, of course, your data is really based on, and what you've been talking about for a while, is actually the cost-effectiveness of putting in ICMs early, and so the issue is contribution margin of index admission with ICM or not, if you want to speak to that. Yeah, it was all based on the index admission. So, it was based on that index, and so really, our strategy for all our economic analysis was, how are you going to manage that patient from the index admission? So, and then we modeled the numbers based from that, and we included, we tried to model as best as we could. We even included the cost of what it would cost, for example, to have, let's say, you did not implant ICM, and you had to then consult cardiology to then determine if you're going to need an ICM, and we included those costs as well, and just remember that, and we also modeled, you know, a surgical DRG versus a non-surgical DRG. Remember, that also changes your billing as an inpatient, so if you get a stroke, but you have no surgical procedures, that's a non-surgical DRG cost for the hospital and to Medicare. If you get an ICM, that's a surgical DRG cost. And then if you have it done as an outpatient, that cost, we compare it to being on an inpatient cost. So, we try to be as comprehensive as possible for that index hospitalization. Got it. Yeah, that makes sense to me. I think it answered the question well, but if not, I'm sure a follow-up will come through, so no worries on that. So, speaking of secondary stroke, and can I just add to that? I think what's really important there is that when you think about, when you're talking to your hospital administrators and creating this program that Dr. Shalfoon and I have in our hospitals and our systems, understanding that you convert a medical stroke DRG to a surgical stroke DRG is not just important in that the administrators realize that it's better for their bottom line for the same patient, but the other part of this, which is really important, is this is how we have argued to actually bring in resources, more APPs, a stronger device clinic, because what that does is it allows us to actually bulk up the resources that take care of our patients and provides better patient care. So, it's looking at this entire system and understanding how you can actually use it to actually deliver more effective care to our patients, but also how you can use it to support your teams that are delivering this care. Yeah, perfect. So, we started out when I was introducing you both talking about your differences from neurology and cardiology, yet you both have cross-functional teams in your organizations, and I think for our audience one of the things, and this may be the last question we get to unless another audience question comes in right now, but tell us about the challenges of building that cross-departmental team between cardio and neuro, what were maybe one or two of the biggest hurdles that you had to overcome in unifying two different service lines around one disease state and one therapeutic and diagnostic area? Can you tell me what was what was the hard part? What will our people be up against? Dr. Jaffone, you want to go first? Sure, sure. So, you know, I'll say fortunately the crux is to have a collaboration knowledge of each other in the beginning, and I think it was easy for us because I knew well some of the neurologists there, and we both believed in that same concept. The challenge for us though is when the neurology teams may change, for example, let's say a leadership happens, you have to make sure that then you reach out again to that leadership team to make sure that they're all on board with the protocol. You know, a lot of new hires happen over the years. They may not be familiar with how important this data is, and so they may be going back to their traditional monitoring because whatever hospital they came from required a, you know, a two-week monitoring before you go to a link, and that's one thing we keep seeing. You know, one of the big things we're having over the years is also changes in reimbursement policy from the different insurance plans. Everybody comes up with a different policy on how many monitors you need now before an ICM, or you can go ahead and do an ICM up front. So, that's our biggest challenge is nowadays is getting different insurances to actually reimburse, especially on the outpatient setting becomes a lot more difficult than on the inpatient. Yeah, and I think for me, I think it's lowering the threshold, and by that I mean that if every time you do this, you're reinventing the wheel, you're not going to do it enough, and you're not going to want to do it enough, right? So, it's really having a standardized protocol, but honestly having mid-levels who are our APPs who are really the best at executing it, whether it be residence fellows or APPs, they run with it, right? So, they know, they call the EP APP, the AP comes and sees them, we make a combined plan to implant that loop, loop gets done. This is the thing, you know, we're going to lower the sort of the resistance to this process by having standardized protocols. The second thing is this, as Najeeb correctly said, things happen in our systems, in every system, and having routine meetings with the EP group and the neurology stroke group, so we can see, are we veering? Of course, are there some things that are coming? Is there a new stroke neurologist who doesn't believe in the data? All of this gets, you know, sometimes it's important to have those follow-up meetings, look at our data, see what's working, see what's not working, and evolve. I'll give you an example, we are at this point next, in April of next year, switching to EPIC, not looking forward to it, but we are, we're going big bang to EPIC for all our hospitals, most of our hospitals. It's going to be a challenge to really, you know, to take what we've done in our current EMR, switch it to that, and make sure it's seamless. So, the only way that happens is with communication and follow-up and looking at the data. So, I think that's really, really important. Thank you. I know we could do this, I could do this for six more hours with you both, but unfortunately, we are time limited. So, Dr. Azar, thank you very much for being here. Dr. Shalfoon, thank you very much again for gracing us on a webinar here. Appreciate both of you. If we have any follow-up questions from our audience, we'll be sure to facilitate and interact and make sure that we get those answered for you. Thanks to everybody else for being here. I appreciate you attending today's webinar, and thanks again to Medtronic for providing the support to make this happen, so we could educate the community. With that, we will end today's webinar. We look forward to seeing you on the next one. Thank you very much. Thank you.

ischemic stroke

neurology

electrophysiology

atrial fibrillation

implantable cardiac monitors

stroke care pathways

multidisciplinary teams

CRYSTAL-AF study

anticoagulation treatment

integrated healthcare strategies