My name is Amber Seiler, and I'm excited to share this information with you today. These are my disclosures. We have a few objectives for today's session. The first is to discuss indications for implantable loop recorder placement. The second is to review some data from implantable loop recorders and look at those examples. And the third is to discuss indication-specific programming and ways to minimize inappropriate transmissions coming into your clinic. So what is a loop recorder? We've spent a lot of time talking about implanted devices, and loop recorders are certainly a subsection of implanted devices. However, these vary significantly from the other devices that we've reviewed in detail in prior modules. Implantable loop recorders is a diagnostic cardiac device. This is different because pacemakers and defibrillators are therapy devices, meaning they actually provide some sort of therapy, either through backup pacing support or through high-voltage therapy to our patients. Implantable loop recorders are implanted under the skin subcutaneously, and these devices continuously record electrical activity of the heart and then store those electrograms when they occur. There are a lot of reasons that patients can get implantable loop recorders, but I want to backtrack for just a minute and talk through the history of why we have implantable loop recorders today. If you've been in the cardiology space for any time at all, you remember the days when we just had Holter monitors or event monitors as options for our patients. These devices were historically available and sometimes adequate for looking for abnormal heart rhythms. We would oftentimes place these monitors externally on our patients for symptoms like palpitations or for syncope, but these devices are certainly limited in their diagnostic ability to give us the information that we need to fully care for our patients and make clinical decisions. Holter monitors are limited in time to usually 24 or a 48-hour period, and event monitors have that same time limitation. In addition, with external monitors, patient compliance is a big factor in us being able to adequately obtain the information and then interpret that information because patients are required to place these monitors on their skin in order for those monitors to pick up the cardiac signals. So over a decade ago now, implantable loop recorders were created with a battery that began at about two years, and now some batteries last up to five years. What this has done is extended our ability to evaluate our patients over time. This is very important as you think about the highest reason for implant for these patient populations. Because cardiac events are usually not located within a specific period of time, the ability to monitor cardiac signals over a longer period of time without requiring intervention or aid from the patient is very beneficial. So let's talk about some of those indications and talk through why longer monitoring might be helpful. The first reason for implant is recurrent unexplained syncope. These are our patients who pass out for no apparent reason, and we're trying to determine if there's a cardiac cause for their syncopal episodes. As you can imagine, if a patient comes into the clinic for syncope, that could have been the first time that they had an event, or it could have been the third or fourth or even more than that. But oftentimes, these events are not localized within a 24 or 48-hour period or even a 30-day period. And so what we're able to do is implant this monitor relatively noninvasively underneath their skin with a battery that now lasts several years so that when they have their next syncopal event, we're able to evaluate their cardiac function at that time and determine if there was a cardiac reason for their syncope. A growing implant indication for implantable loop recorders is our cryptogenic stroke population. There was a study done called CRYSTAL-AF. If you haven't previously reviewed that study, I would encourage you to do so. And what they did is they took our stroke patients, those that had had a stroke with no clear reason for their stroke. Now that's called ESUS, but cryptogenic stroke is also a common term for these patients. And what they found is that with monitoring these patients through an implantable loop recorder, we were able to find atrial fibrillation at a much higher rate than those patients who were monitored with an external 30-day monitor. The reason this is important is that all of our stroke patients have a CHADS-VASc score or a stroke risk score of at least two, which means that if any atrial fibrillation is detected, they would be appropriate to be considered for anticoagulation. So through implantable loop recorders, we've been able to greatly extend the scope of patients that we're able to monitor that have had a history of cryptogenic stroke and positively impact their outcomes by placing them on anticoagulation when it's appropriate. Another reason for implantable loop recorders is palpitations or other transient symptoms felt to be arrhythmogenic. That's a very vague term. Usually people say that they're implanting for palpitations. So these are our patients that most often have worn an external monitor in the past to try to capture the reason for their palpitations. Oftentimes these patients also have personal wearables like Apple watches and they've been unable to capture their arrhythmias. And what these devices do is, again, allows for a much longer term monitoring period and allows for things like patient-triggered events. So the patient can actually tell the device, I'm having a symptom, and the device can then go back in time for a certain period and capture those events that were happening leading up to that patient-triggered episode. The last big bucket of implant indications for our implantable loop recorders are atrial fibrillation management. As you can imagine, and I'm sure you're aware, the patient population that has atrial fibrillation is growing. And historically, we've been limited in the information that we have to impact our clinical decision-making for these patients. Now with implantable loop recorders and battery longevities that last several years, we're able to evaluate how frequently their AFib episodes occur, how long those episodes last, and also their heart rate response whenever they are in atrial fibrillation. This information is able to help us make clinical judgments around medical therapy and also the need for possible repeat procedures. I want to review again just very quickly the benefits of remote monitoring. The reason is because these devices, while very valuable, are only valuable if we're able to obtain the information. And the only way really to obtain information out of these devices in a way that's able to help us impact our patients clinically is through remote monitoring. So we know that with remote monitoring, we're able to increase clinic efficiency. We're also able to reduce healthcare utilization, expedite our clinical decision-making, and increase survival rates. You can imagine with the patient populations that we've talked about today, these things could all be true. I would like, though, to highlight the expediting clinical decision-making because that's really the crux of why these devices are implanted. All of these devices are enabled with Bluetooth technology, which allows them to communicate with either a patient's bedside monitor or an app on their mobile phone or one that's provided to them from the manufacturer. Each manufacturer has a different way of monitoring these patients, and I would encourage you to understand how that monitoring works for each of the vendors that you're associated with, what your options are for patient monitoring, how to help ensure adequate compliance, and what the process is for getting patients a new monitor should that need arise. Whenever these devices collect information, they are programmed to trigger transmissions back to the clinic based off of certain events. We're going to talk through some of those scenarios and best practices around those scenarios a little bit later today, but what I want you to know is that connectivity for these patients is paramount. In order for us to obtain the information from this device, they have to be remotely monitored and they have to be connected. For our cryptogenic stroke patients, for example, this is incredibly important. Most manufacturers will let us know when patients' monitors are disconnected so that we can reach out to the patients to ensure connectivity. I think, personally, for our cryptogenic stroke population, this is something that can't be missed, and so if you don't currently have a process in place or if your clinic doesn't currently have a process in place for managing disconnected monitors and reaching out to those patients to make sure that they are connected and that they stay connected, I would encourage you to develop that process internally so that you're able to obtain information like new AFib if that occurs. So let's spend a little bit of time talking about data interpretation, and the way that I like to tell this story is through some case examples, but let's talk through some key considerations first. So implantable loop recorders do not have leads inside the heart. I want you to think of interpreting these devices' electrograms more like an external halter or an event monitor. We don't have the value or the luxury of seeing the heart's cardiac activity from a lead tip like we do from our pacemakers or our defibrillators. And so because of this limitation, we have to recognize that there will be an increased number of false positives and also occasional poor data quality from these devices. Data quality and the ability of these devices to correctly interpret the data that it's receiving is largely based on implant technique and also patient's body habitus. So there are some ways that we can get around poor data quality or optimizing programming to limit false positives, but that journey really begins at implant. All four of the major device manufacturers now make implantable loop recorders. It is important to understand that features are manufacturer-specific when evaluating device data and programming options. I would also encourage you to look at each manufacturer's sensitivity and specificity results and look at the published data around their specific devices. Some manufacturers have been in this space for a very long time, others not as long. But as you're thinking about which device is more appropriate for your patient and their needs, there may be situations where going with a specific manufacturer is valuable over another. Whenever we think about workflow for implantable loop recorders, we need to make sure that the whole team is on board with what's happening and that everyone understands who's responsible for which pieces of this workflow. So again, all loop recorders have the ability to send alert transmissions, primarily through Bluetooth connection, either through a monitor at the patient's bedside or through their app on a mobile device, but connectivity is key. And I know that we spoke about that before, but I really want to highlight it again here. Without device connectivity, we will not receive any data, which means that the device, while still recording all that data, is not helping us to inform a patient's clinical decision-making process. A typical loop recorder workflow includes daily management of alert transmissions and monthly review of all data. The monthly transmission is the one primarily used for billing. So normally what happens is, all of these devices, let's say you have a clinic of 500 loop recorder patients, every night for patients that are connected, the device is going to do a handshake with the patient's bedside monitor or the app on its phone, and it's going to say, do you have any new information for me that I need to send to the clinic? And how that determination is made is based off of which alerts you have programmed on to receive, both in the device and also in the manufacturer's website. So I want you to keep that in mind as we go through this session today and talk about programming. There's two different types of programming. We have device programming, and then we also have alert programming on the website. Those two are distinct tasks, but they both impact the number of transmissions that our clinics are going to receive. So for our clinic of 500 patients, again, every night the device is going to do a handshake with the monitor and say, is there anything that you need me to send to the clinic? And so each morning when you or your clinic team members walk in, on those manufacturer websites there's going to be those alert transmissions there that met both device detected criteria and also our website alert programming criteria. Both of those things had to be true in order to get that alert transmission. We'll also see things on our websites like summary reports or monthly checks. And this data is meant to be a comprehensive review of everything that happened since that last summary report or since that last monthly check. Now you can choose which interval that you would like to set these checks up to. Most clinics choose 31 days because according to billing guidelines, that's how often we can build these transmissions, and they are a lot of work. And so we should capture the revenue that we can whenever we're able to, to manage these devices. Some clinics don't have the staffing they need, and so they've chosen to stretch out those summary reports to every 91 days or every 45 days. I would just encourage you that if you choose to extend that billing period, all of that information does still have to be reviewed. You're just choosing how often your clinic gets reimbursed for doing that work. Again, connectivity management cannot be overemphasized, and there is a need for clinic-specific protocols around device programming, disconnected monitor management, and notification of actionable events. I personally am a big believer in protocols for all things in EP, but for loop recorders, this is especially important. So if you don't have protocols that tell you what alerts are programmed on for a patient-specific population or at which point you're going to manage and reach out to your disconnected monitors, I would really encourage you to try to create those together with partnership from your physicians and the rest of your clinic team. So let's talk through a few case studies. So TW is a 78-year-old male with a past medical history of hypertension, diabetes, and coronary artery disease. He presented to the hospital with expressive aphasia and left-sided weakness. Imaging did demonstrate an embolic stroke, and his workup was negative. And so in prior systems that I've worked in, our plan at this point is to implant a loop recorder based off of crystal AFib data and the fact that we know that we're probably going to find atrial fibrillation in these patients at least 30% of the time. So as we think through things and as we think through loop recorders and who it might be appropriate to implant these in, we know this patient had a stroke. We also know that his CHADS-VASc score is very high, not only because of the stroke, but also because of the addition of hypertension, diabetes, and coronary artery disease. Some things to think about when you're implanting loop recorders for your stroke patients, one, is the patient capable of understanding what that device is for and participating in remote monitoring? Again, if we found atrial fibrillation in this patient, would we be able to call him or a family member, explain what we found, and be able to initiate anticoagulation if that was still important? The second thing to consider is cost. Because these devices are capable of being billed every 31 days, it's also very important to be transparent with your patients prior to implant to let them know what the monitoring of these devices is and to give them a sense of what that cost will be to those patients prior to implant. So whenever you implant a device, especially the loop recorders, all manufacturers now have implant indication programming. And so what this means is if you pick syncope as a patient's implant indication, there are going to be a set of defaults programmed on for both inside of the device and website alert programming. If you choose another implant indication, for example, AFib diagnosis, which would be the implant indication we would use for our stroke patients, a completely different set of default programming is going to be utilized. And the reason for that is because for our syncope patients, we might want them to have a patient activator where they can trigger an event to be stored within the device. But for our stroke patients, we're looking for an asymptomatic arrhythmia. So we may choose not to give those patients a symptom activator because we don't expect them to have symptoms that we would like for them to track. There are also other defaults for implant indications, including AFib management, palpitations, VT. There's an exhaustive list that's located within each device and each manufacturer's website that you're able to choose the most appropriate diagnosis that aligns with their clinical picture. I would encourage you to do that. And I would also encourage you as a clinic to look at what the manufacturer defaults are and also ensure that that's in line with what your physicians are actually wanting to see. Sometimes these can be tweaked to where you're actually receiving less information because that's what your physicians feel is appropriate. So for our stroke patients, there are a few things that we feel like are appropriate to program on. The first obviously is AFib episode. We're wanting to make sure that we do detect any AFib episode that the patient has detected by its device. We also want to make sure that we're notified for every single AFib episode. The other alert that we often program on is tachycardia episode. And the reason is that some of the AFib episodes are too short to meet AFib detection criteria as defined by the device, but they might actually be short bursts of AFib with RVR that are found in the tachy episode detections. We typically don't program on symptom plus detected episode again, because we're looking for an asymptomatic arrhythmia for our patients, and we don't expect them to have symptoms related to it. We also oftentimes turn off both in the website and also in the device, pause and Brady detections for our AFib detection patients. So for our stroke patients. And the reason is, is because these devices are very, very, very good at detecting pause and Brady events. But a lot of the stroke patients have comorbidities that are also comorbidities for sleep apnea. And so we would find lots of non-actionable pause and Brady events detected whenever we had that programmed on for this group of patients. So that's a decision for you and your physicians to make as to what you think is most appropriate. But oftentimes we would program those off because there was no clinical reason to have those programmed on. So back to our stroke patient. This is an episode that came in that was detected. Again, this is a scatter plot, much like our therapy devices, just to orient ourselves. We've got time in seconds along the bottom, and then we have rate along the side. This is in beats per minute. The higher the dot plot on the graph is actually the faster the rate. That's opposite from our therapy device scatter plots that we've looked at previously. This is the EGM that we see. Again, I want to encourage you to think about this like a Holter or an event monitor EGM. So leads not within the heart. The marker channels that you're gonna see here are V-sensed events or tachy-sensed events, depending on how you have the device programmed to detect tachy events. And what you're seeing are the QRS complexes as the large complexes. What we don't see here are any clear P waves. And we also see that we have a very irregular rhythm. So when we looked at the scatter plot, we could also see that irregularity, which is confirmed by the EGM. And this is most likely atrial fibrillation. Interestingly, what we don't take into account very often for our patients that are implanted for cryptogenic stroke and their atrial fibrillation is how long the episodes last. And that's because most physicians, yours should be asked how they feel about this, but feel that any AFib in a stroke patient is enough AFib to warrant at least the conversation around anticoagulation. So if you remember in our device patients, we talked about depending on their CHADS-VASc score may dictate how long the episode of AFib is that you want to detect. For our stroke patients in particular, for loop recorders, we want to make sure that we're capturing any AFib that's detected so that we can at least have the conversation around anticoagulation and see if that's appropriate for that patient. So once we detect atrial fibrillation, then what? And I always want you to ask, then what? Because now that we have AFib detected, we're no longer in an AFib diagnosis patient profile. At that point, we're in an AFib management patient profile and our alert programming and potentially our device programming should reflect this change in our patient. So what we normally do, we want to make sure that we detect our AFib episodes, but we're looking more for AFib with a rapid ventricular response. So normally what we do is we would turn V rate greater than a hundred beats per minute for four hours. At this point, we would also turn pause episodes on. And the reason for that is this, patients that have cryptogenic stroke and atrial fibrillation don't just have atrial fibrillation. They often have atrial fibrillation that goes very fast and necessitate some sort of rate control strategy. And so if you're initiating a rate control strategy, at that point, it's very appropriate to also make sure that the patient's heart rate aren't going too slow. We move the patient out of a stroke satellite clinic in the website, if that's how you have it set up. But mostly what this is getting to is moving them again from that AFib diagnosis state to an AFib management state. We don't program on symptom plus detected episode. We actually don't program on AFib detection because at this point, we know the patient has atrial fibrillation. And so we don't need to detect every single episode of atrial fibrillation. AFib burden is one that can be negotiated with your physicians and how they feel. If your patient's asymptomatic with relatively good rate control, you could certainly argue that you don't need AFib burden programmed on. A lot of our stroke patients aren't candidates for further AFib procedures like ablation. However, some may be. And so for those patients, you certainly may want to look at AFib burden over time. The biggest point here is that our patient situation has changed. And so our device programming and our alert programming should also change for our patient. So this is what our stroke patient did that we've been speaking of. So as you can see here, the markers at the top are months over time. The eyes are when we've interrogated this device. And the trend line here is how often the patient had atrial fibrillation. So you can see a little bit of atrial fibrillation, back to sinus rhythm, some more atrial fibrillation. And then we had a fairly long break with no atrial fibrillation. Also stresses the importance of having these implanted monitors in place, as opposed to a 30-day monitor. Another long break with no atrial fibrillation, but then look what happens. Not only did we go back into atrial fibrillation, but we're also now persistently in atrial fibrillation. And so this is a clinical change for the patient and should warrant a phone call to assess symptoms and make sure that we don't need to do anything different from a rhythm control strategy for this patient. So like I said, not only do our stroke patients have atrial fibrillation, they also have atrial fibrillation that oftentimes goes very fast. So what you can see here are two histograms. We talked about histograms prior. The one on the left-hand side is when our patient is in sinus rhythm. So this histogram looks very appropriate, bell-shaped curve, very good heart rate distribution. The histogram on the right-hand side of the page is whenever the patient is in atrial fibrillation. And what we can see is almost all of the time, the patient heart rate is greater than 100 beats per minute whenever they're in atrial fibrillation. Now, this isn't as much time as when they were in sinus rhythm. You can notice the time stamps here. So we were in sinus rhythm for 72 days and an atrial fibrillation less than one day, but these heart rates are fast enough to warrant some more investigation and to determine should we make a medication change based off of this information. So for this patient in particular, we decided to rate control this patient because their rates were very fast. And this is why we programmed pulse on because this patient, we did a very good job on rate controlling and they had a seven-second pulse. And so at this point you have a decision to make, but the beautiful thing about loop recorders is that you have the information that you need to make that decision. So again, as you're thinking about your patients, especially our stroke patients, but really any patient population, I always want you to think about what information are we trying to clinically obtain that's gonna impact this patient's care? And how can I make sure I get that information and I don't receive information that is not going to clinically impact my patient's care? So this patient in particular was implanted with a dual chamber pacemaker. And at that point, you have to determine which alerts are needed to be on now that he has a pacemaker and no atrial fibrillation. Again, back to what we talked about when we were talking about therapy devices. He has known AFib, we're on anticoagulation, presumably asymptomatic. And so what AFib do you want to know about now that we're going from monitoring periods of 31 days to 91 days? So we're not seeing the information as often, what do you wanna be alerted about? And that's a patient by patient decision and one that you should make with your providers, but just questions to think about, especially in our loop recorder patient population. So let's look at another example. So this is a 65 year old male. He had a loop recorder placed for evaluation of syncope. And in this strip, what we can see is that we have the scatter plot at the top. Again, rate and beats per minute is on the left-hand side, time across the bottom. What this looks like to me as we go back in time is that we have a pretty normal sinus rhythm, perhaps some PACs or some PVCs. And then all of a sudden our heart rate drops before we go back to sinus rhythm again. Underneath here is our EGM. Again, I really want you to think about this device is like a Holter monitor or an event monitor. And so we're seeing it from the outside of the chest or as close to it as we can get. And what we can see is that we have sinus rhythm and then all of a sudden we have these complexes that aren't followed by our traditional QRS complex. And so the question is, what is those? And what do we do about that? So I think you have a couple of options here. One option is to take this for relative face value and say, you know what? Those look like P waves because that's what the rest of these P waves looked like. And I'm gonna call this some sort of heart block. Another option would be to question, are those really P waves or do we need to evaluate further? I would encourage you as you're looking at implantable loop recorder strips to always evaluate further. These strips are not as easy to interpret as intracardiac electrograms, again, because we lose some sensitivity and specificity with not having leads implanted directly into the heart. And so as we look at this, there's a few options for further investigation. The one that's most common and that all manufacturers have is the ability to zoom in on this strip. And so whenever you zoom in, there's a couple of things that you could see. You could see either, yes, these truly are P waves marching through, or perhaps these are actually QRS complexes and there's P waves that are smaller in front of those. It's really difficult to tell with this strip that we have in front of us, but I do want to encourage you to always look a little bit further. We never wanna make a decision for a patient, especially potentially implanting a pacemaker, which is a fairly invasive procedure if the patient doesn't actually need it. The other thing that I would encourage you to do whenever you get a strip like this is to call the patient or reach out through the patient portal and assess if they had symptoms. Oftentimes that can indicate whether or not these pauses or Brady events were real or false. And then also never hesitate to reach out to tech services for the manufacturer to see if they're able to see anything that you can't see when you're evaluating these strips. Oftentimes strips for loop recorders are very straightforward and you're like, yes, I know exactly what that is. But it's not uncommon to find strips that are a little bit more ambiguous where you're having to dive deeper to actually figure out what was recorded here. So let's look at another example. This is a 72 year old male who has a loop recorder placed for cryptogenic stroke. And what we can see on the left-hand side here is that we have our scatter plot with text underneath it. The text is telling us that the device detected an AFib episode at 6.24 in the morning. The duration of the episode was two minutes and our maximum ventricular rate was 140 beats per minute. And our median ventricular rate was 122 beats per minute. There is another piece of information on this text that is incredibly helpful, especially as you're evaluating tachy episodes, Paul's episodes or Brady episodes. And that's what the patient was doing at the time of episode detection. So in this episode, we can see that the patient's activity level was inactive. So the loop recorder is saying, I'm not detecting that the patient is moving at this time. So I'm gonna tell the clinicians that the patient was inactive during this episode detection. Now this scatter plot is very different from the one that we just looked at. And you can see that the dots here are much more erratic and irregular, that the rate varies, but that there is this line going through the middle here of some regularity. And so as we look at the EGM on the right-hand side, I do wanna encourage you to never take the device detected episode and what the device thinks it is as gospel. We always need to look at these for ourselves. So on the right-hand side here, again, we can see that the device declared this AFib episode. We see V sense events, not so terribly fast, but there is some irregularity to this, which is also represented by the scatter plot. I'm gonna give you a second to look at this strip because it's actually a very clean EGM and not something that we get to see very often and ask you what you would do. So again, we're thinking about this strip as if it's from a Holter monitor or an event monitor. We also know this device was implanted for cryptogenic stroke. This is actually an atrial flutter that was detected by the device, which explains that regularity that we can see going through the middle of that scatter plot with some irregularity around it. So for this patient, initiation of anticoagulation, or at least the discussion around initiation of anticoagulation would be the appropriate next step. Here's another example. So this patient is 72 years old. Her lube recorder is placed for palpitations. She has a normal echocardiogram. Why is that important? It's important because it tells us that we don't think she's at risk for life-threatening ventricular arrhythmias based off of who normally is at risk for life-threatening ventricular arrhythmias. May happen, but normal echocardiogram is reassuring. We can see here a few things. So on the left-hand side of the screen, we have our scatter plot at the top. Again, the faster rates are toward the top of that scatter plot. Underneath there, we can see our episode text. There are a few highlights here. The first is that the device declared this a tacky episode. It started at 7.06 in the evening, and it lasted for a minute and 12 seconds. The rate was very fast, 240 beats per minute max and 231 beats per minute as a median rate. But this is the most important thing I want you to see on this text, is that this is episode number 2,210 in this device. And while I told you that these devices are lasting longer and that we have batteries now that can last up to five years in implantable loop recorders, I would encourage you very strongly that if you ever have a situation where your episode counter is more than three digits, that we should really look at device programming because what that meant is that you have looked at all of those episodes, but not taken a clinical action that either determined the patient needed a different action or programming or medication adjustments to make those episodes stop being detected. So if this patient had 2,210 tacky episodes total, that means that we looked at 2,209 episodes before this one and said those events weren't clinically actionable for me to do anything about. And so I think that we can learn from that by looking at our parameters. So we have our RENVID detection here set to detect at 12 beats for 162 beats per minute. Whenever we're looking at tacky detections, oftentimes the device is determining that rate based off of the patient's age. That is something that you can overwrite through device programming, but you would have to manually do that. And so for this patient, what I would have done, having looked at 2,209 tacky episodes before this one, is either A, choose to extend that detection to where it's longer than 12 beats, or raise that tacky rate to faster than 162 beats per minute. And the reason is, is because maybe this patient is very active and she gets her heart rate up during exercise. We don't wanna see sinus tack, and clearly someone's looked at over 2,000 events prior to this one. And so again, just as you're looking at things, thinking about what's most appropriate for this patient, and what am I clinically going to do something about? So over here on the right-hand side, we have our EGM, which is actually very impressive. So we can see here, we've got some sinus beats at the top, couple of ectopic beats. We also have an undersense PVC there on that top line, which is interesting. And then we go into this tachycardia. And so the tachycardia starts to be detected. It's wider complex than her normal QRS complexes. And you can see there that it says the ECG was suspended for 49 seconds. So what the device is gonna do if episodes last a long time is it's gonna make sure it captures onset for you. And then it's also gonna make sure that it captures termination. Because oftentimes between onset and termination, we're able to make a determination about what that episode truly was. So what I would say about this rhythm are a few things. One, we know that it's fast, and we know that we should get it in front of a physician to look at, to make a determination on what this rhythm is and what they would like to do about it. The first thing that I would do though is call the patient and assess if she had any symptoms associated with this rhythm during this time. The good news is it happened at seven o'clock in the evening so she should have been awake. And using that symptom evaluation will also help us to determine what our next course of action is. When you call patients to assess for symptoms for episodes, especially those that occur in the setting of an implant indication of palpitations, I would encourage you to ask a few follow-up questions. So don't only ask, did you have any symptoms, but also try to find out from the patient, is this the same thing you were feeling when we put this device in to try to capture or was it different? And then also make sure that she's not having other symptoms that we may still need to want to capture. Okay, so let's take a break here and just switch over to device programming. As we think about device programming, as we talked about before, we have programming within the device and then we also have website alert programming. Let's focus for just a second on programming within the device. So I want you to have a standard approach to evaluating alerts and reprogramming for non-actionable events. Oftentimes that does start with device programming. This is where those clinic protocols come into play and having your physician sign off ahead of time to say, in these situations, these are the programming changes that can be made that would be appropriate for all patients. You also need to find a consistent place to document programming changes. That can either be in your device database, your EMR or the remote website. For some manufacturers now, we have the option of actual device reprogramming through the remote websites. So we're able to remotely reprogram how the device is told to detect and store events through the remote websites without having to bring patients back into our clinics. That's a relatively new feature that device manufacturers have enabled. It's incredibly beneficial. As you think about our patient populations that we most often implant, cryptogenic stroke, syncope, oftentimes those patients have transportation challenges. And so being able to reprogram these devices through the remote websites is incredibly helpful. I also want to encourage you to empower all staff to identify patients who could benefit from reprogramming. I want you to think about managing loop recorder alerts as weeding a garden. So it's not something that you can just do once and be done with it. You've got to continuously look for opportunities to optimize your patient's programming to limit non-actionable transmissions that are coming into the clinic. And then have open discussions with providers about the benefits of reprogramming and time saved by eliminating excessive non-actionable alert transmissions. In the time and motion study that was published in 2021, we saw that it takes 9.4 hours per patient per year to manage an implantable loop recorder. That's a lot of hours. A lot of that burden is driven by these non-actionable alert transmissions. And we're going to talk about a little bit later a decision tree to walk through to try to limit those transmissions so that we're only receiving either actionable events or billable transmissions. A couple of workflow best practices to consider. Optimizing the patient at every touch point. So for our loop recorder patients, this is meant to be a remote follow-up device. So these patients aren't often scheduled for annual follow-up like our therapy devices. So anytime you have the opportunity to capture the patient in front of you and optimize their programming, I would encourage you to take advantage of it. Another best practice is if multiple clinicians are following loop recorders, again, considering those clinic-wide protocols around disconnected monitors, indication-based programming, device programming, alert programming, and an escalation protocol. At a prior clinic, for example, one of our protocols was for our cryptogenic stroke patients. And what we said was that if a cryptogenic stroke patient had AFib detected, whoever pulled that alert off the website had four hours to get it in front of a provider to make a decision about anticoagulation. And what that meant was that our cryptogenic stroke patients were anticoagulated oftentimes within 24 hours of their first AFib detection. It's very aggressive. It was also very effective. We did several abstracts that were published which demonstrated a reduced ischemic stroke rate for our patients that were monitored with implanted loop recorders that had had a prior cryptogenic stroke. Whenever you see patients in implant, teaching them the importance of only performing a manual download when instructed to do so by the clinic and reinforcing that at wound check. Patients can often get trigger happy with their symptom activators. That's for a few different reasons. One, they're scared. They are having symptoms and they don't know what's going on. And so they're trying to make sure that you're getting everything they're feeling and every possible piece of data that they can give to you. The other though in most common situation is that patients don't understand what the symptom activator should be used for. And so oftentimes these patients have worn external monitors and a symptom activator was the only way to record that data. So sometimes some patient re-education around like your device is programmed to detect automatically any arrhythmias that might occur. So you don't always need to use that symptom activator. And then back to reprogramming, having a very low, and you can read that non-existent threshold for reprogramming alerts or bringing patients back into the office for reprogramming and re-education when needed. And the reason is these devices, as we talked about, create a huge burden of work for our clinics. And so whatever we can do to optimize our loop recorder patients has an exponential impact on the time it takes to manage our full device patient population. Let's talk about website reprogramming for just a little bit. I want to share a few abstracts that have been done looking at the value of website reprogramming and the reduction in alerts that can occur with some effort in making these programming changes. So the first abstract that I want to talk to was published in 2023. It was published in Jack. What we did is we took a clinic and we looked at how many non-actionable alert transmissions were coming into that clinic at any given time. And so what we found at baseline was that 767 patients received at least one alert over a 48-hour period. That was 63.4% of their patient population had an alert in that 48-hour period. That's a huge number. And you can imagine as your patient population grows, that's just not sustainable. And so what we did is we applied indication-based alert programming to these patients. Most of these patients had devices where we were only able to reprogram alerts, but not able to reprogram the device itself. But even through just website alert reprogramming, where we were able to decrease that to only 164 daily alerts at the baseline to 43 daily alerts after reprogramming, which was a 73% reduction in alerts received. And importantly, these were all non-actionable alerts. So what we were trying to do is to decrease the size of our haystack so that we could more quickly find our needles. You can imagine that if you walked in on one day and you had 164 alerts to review, then the likelihood of you finding those transmissions that were actually actionable at the very beginning of your day would be significantly decreased because just of the sheer volume of work that you had to get through to review all of those transmissions. So whatever we can do to make the size of that haystack smaller, decreasing the number of transmissions that are coming in that are not actionable, that should be our goal every time that we look at these patients and at these alerts that are coming into our clinics. The 30-day alert burden for this clinic dropped from 3,599 transmissions to 954 transmissions overall. 351 devices required reprogramming, which reduced the burden to an average of two alerts per patient during the following 30-day period. And most importantly, no clinical or device-related adverse events were reported. So this just goes to show that we're able to make programming changes for our non-actual alerts without negatively impacting our patient's clinical care, but dramatically improving efficiencies within our device clinics. So as we think about alerts and loop recorder alerts specifically that are coming into our clinic, I want you to go through a decision tree in your mind every time that you receive a patient transmission. So when an alert comes in, I want you to ask yourself, is it actionable or is it not actionable? The actionable ones are actually the least common, so we'll start there. And then the question is, does it meet your triage protocol? Meaning, did it meet a protocol that says that I need to call the patient or I need to escalate this to a provider? If the answer was yes, then obviously do those steps. But if you receive an alert transmission and it's not actionable, or it was actionable, but it didn't meet triage protocol, so say for example, yes, a patient did have appropriate atrial fibrillation detected, but our physicians have said we only wanna see that for six hours as opposed to 30 minutes, then that wouldn't have met triage protocol. And so then the question is, well, is this redundant? Meaning, have we gotten another transmission like this for this patient before? If the answer is no, it's very, very, very reasonable to say, well, let's just continue to monitor and not do something different right now. But if the answer is yes, which is oftentimes the case, then the question should be, can it be adjusted? And I have in our decision tree, can it be adjusted per the protocol? Because again, I've encouraged you to look at the protocol right now to make sure that you do have a protocol in place for your clinic. And one of those should be what you're allowed to reprogram if you're receiving non-actual alerts for a patient. There are a few common examples. Let's say that you have a patient who was implanted for syncope, and you're getting frequent alerts for nocturnal pauses or nocturnal Brady events that are asymptomatic. A few options for reprogramming would be to either extend the duration of those events so that you're not seeing the ones that aren't actionable, or to make sure the patient has a symptom activator and saying, if you have an episode, I need you to press this activator so that the device will also record and eliminate those device detected automatic events from coming through as alert transmissions. If that happens, it's important to know that even if you choose to turn the alert off in the website, this is very different from device programming. If you choose to turn the alert off in the website, you will still get that information on your summary report at the 30 day interval because the device still detected that event. It's also very important to know that should the patient call you and say, I had this episode, I forgot to press my symptom button, that you would still be able to see that episode if you pulled up that patient on the manufacturer website. So alert reprogramming through the website isn't necessarily telling the device don't see it, it's just not sending you those transmissions that you don't want for immediate action. If you have patients with redundant alert transmissions and they don't meet your reprogramming protocol, I would encourage you to take those to your physicians. I have spoken with lots of physicians over the years who manage device clinics and I've not met one yet who is looking to add more work to their device clinic. They do want to be true partners with you in reducing non-actual alerts. The biggest challenge is often they don't know how to help. And so if you're able to talk with your physicians and bring to them suggestions for reprogramming, that's ideal because then they'll be able to act on that and hopefully give you some guidance in how you can reprogram those devices or the alerts as they're coming into the websites. If you do reprogram those alerts, again, it's very important to document that reprogramming in a place that's consistent across your whole clinic. And as a clinic, you can decide where you want that to be. So let's look at one final abstract together. This one was published in 2024 and it was looking at alert reduction using remote reprogramming. And so what this study did is it took 19,525 patients that received a Link2 device. This device is specific to Medtronic and Medtronic did sponsor this study. But what we wanted to look at is were we able to significantly impact the number of non-actionable alerts that were received through remote reprogramming and also what were clinicians comfort level with remote reprogramming? And so what we found is that we were able to decrease loop recorder alerts by 20.5% after reprogramming. Now this was a combination of different reprogramming types, but this is mostly device reprogramming because with Link2 devices like several other manufacturers, you're actually able to reprogram the device remotely without requiring patients come back into the office for reprogramming through a programmer. So what we found is that reprogramming for these patients happens sooner after implant and more frequently after follow-up versus our Link1 patients, which did not have that device reprogramming capability built in to the system. Remote reprogramming was anticipated to save 211 hours per 100 loop recorder patients managed annually. That is a significant amount of device clinician time that was saved. And with remote capabilities, use of ICM alert reprogramming has grown with the potential to reduce clinic and patient burden for follow-up and allow clinicians to have more time for other care responsibilities. If you remember, we've spoken a lot about our stroke patients and these patients do have real transportation challenges. And so historically, if we were having a lot of faults AFib detections, we would have to bring our patients back into the office for reprogramming. And oftentimes the decision to make that reprogramming change and the patient's ability to get back into the office physically was a significant delay. And so with this technology advancement and our ability now to reprogram the actual devices through remote reprogramming, we can intervene sooner for these patients and help to decrease those non-actual transmissions on a level that we've never been able to do before. So I'm gonna finish here and just stress again, the importance of the differences in implantable loop recorders and our therapy devices that we've talked through in the past. We know that our implantable loop recorders are implanted for specific use cases, oftentimes as a diagnostic device to help us determine if there's an arrhythmia associated with our patient's clinical condition. Whereas our therapy devices are designed to actually give therapy, either through backup Brady pacing support or through high voltage therapy with our defibrillators. This patient population does warrant unique programming considerations by indication because we want to ensure that we're only getting information that's gonna be clinically actionable for our patients and that we're able to act on that action whenever we receive that data. Connectivity is incredibly important again for this patient population, making sure that you have a method in place to manage patient connectivity. And probably the most important thing as you're starting this journey as a device clinician or as you're talking with your clinic colleagues is physician partnership. The physicians that I know and that I've spoken to are very, very willing to help you create protocols and policies to allow you to have the autonomy that you need to reprogram these devices and decrease non-actionable alerts. It is, however, our job as clinicians to give them the information they need to act on those recommendations. These are our references. And for any questions, you can email academyatmedaxiom.com.

implantable loop recorders

heart's electrical activity

subcutaneously

electrograms

unexplained syncope

atrial fibrillation

remote monitoring

device programming

patient outcomes