Good morning, everybody. It's my pleasure to welcome you to the San Diego and Heart Rhythm 2025, the 46th Annual Meeting of the Heart Rhythm Society. If you have not already done so, please download the Heart HRS 2025 mobile app for your preferred app store. This is how you can participate in the live Q&A sessions. Please scan the QR code on the screen to access this session's Q&A. When using the mobile app, log in to your HRS credentials. Please note that visual reproduction of the Heart Rhythm 2025, either by video or still photography, is strictly prohibited. Now, moving on, this is a practical guide to CIED management for the allied health professionals. My name is Monica Austin. I'm your chair. My name is Brittany Paulin, and I'm the co-chair. To start us off today, we have CIED Blueprint for Onboarding the Allied Professional by Casey Cherveny from Duke University. Welcome. I'm short, so hopefully everybody can see me. Okay. Good morning, everyone. My name is Casey Cherveny. I am a nurse clinician with Duke EP, and I would like to add that I'm a first-time HRS attendee and a first-time HRS presenter. So I would like to express my gratitude to HRS and everybody that took part in making this meeting possible. I want to give my team thanks for all their support, and today I'm going to be discussing CID Blueprint for onboarding the allied professional. My hope is that this session will serve as a guideline for more inter-institutional device training. Some of this could be common knowledge or a refresher, or maybe some of it's brand-new to you. And I have nothing to disclose. So what is the Blueprint? It's basically just going to serve as a guideline for the allied professional in CID management and just a more structured system, not only for learning, but implementing and providing your device care. And it's going to serve as a standard of care for device management with the ultimate goal, obviously, is going to be patient safety. But furthermore, we want to optimize our devices and utilize optimization in our CID patients and our arrhythmic population. So what is going to be involved in our Blueprint? I'm going to use the 5W1H method. So who are we talking about? Our allied professionals. And our what is going to be the onboarding system, which is going to be utilized through this Blueprint I'm going to be discussing. Our where is going to vary. It depends on if you're in a clinic or a hospital setting or if you're an industry employee, it could be in the patient's home. And then our when is I want to focus on early. So early training and modules. And obviously, the time for orientation is going to vary depending on where your practice is. Our why, I want to focus on structure and more responsive feedback. And our how is our Blueprint and using the system for training to help us stay up to date on our practice. Can I have a show of hands? Who is a nurse here? Okay. Woo-hoo. Who is an APP, nurse practitioner, PA? Okay. Awesome. Do we have any industry employees, device reps, device technicians? Cool. Okay. Any MDs? Okay. So we obviously have a variety, which is kind of what I was, you know, looking for. With this mix of people, we obviously have some representation here that the roles in our clinic are going to vary. And our clinic setup is going to vary. So we're going to be focusing on expertise about specific features with EP equipment, including, you know, our CID devices, which the various discipline and roles are, like I said, they're all inclusive to many different allied professional roles. Historically, the IEAP was defined as individuals with expertise in CID management. But we know it extends beyond that. I mean, there's halter monitoring. There's arrhythmia training. There's educating and counseling our patients. That's a huge part of it. And then our follow-up and device clinics, clinical research, it's all-encompassing, and it is a lot to cover. The guideline state, a supervising provider does not need to be physically present, but you should have one that is readily available. And we're obviously going to provide technical expertise on the implanted device and operation of various vendors' equipment. So here's some, just some brief tips. I would say it would be helpful to provide a detailed orientation packet just to get a solid foundation. And early on, set up a mentor. Have somebody specific that, you know, somebody can have a home base for, because it, you know, it does vary in clinics, but a lot of clinics you're getting training with multiple professionals, and it can help to have just one person that you can go back to and bounce your questions off of. I would say do not overwhelm, but EP is just weird and complex, and it is overwhelming, but just, I think, in training, knowing when to take pause, and being able to recognize whoever you're onboarding, I think you just need to step away, and let's just refresh. So that's going to be super important. And then knowing your resources, what's available, and then setting realistic, you know, timely goals. And then some resources we use a lot is the nuts and bolts, and then the understanding EKG and rapid EKG interpretation, I felt was super important in our orientation, and I think, I thought these were, you know, I think they're very common resources, but some of you may have not seen those before, so I wanted to include that. And then, of course, we have to talk about barriers. There, you know, there's not enough inter-institutional channels of learning, and it is, can be cost prohibitive. There are programs out there, but it takes, you know, your organization support to do that. Clinics vary in process and operation, and so timing's going to vary depending on your background, and then just education and training is going to vary depending on what your specific role is in clinic. And this role takes a while to get, and it's not a one-size-fits-all approach. So the why, you know, our benefit to the blueprint is going to be just faster, more comprehensive learning, hopefully less clinic disruption, and just providing more longitudinal care for our patients, and this is a growing industry. I mean, there's over 400,000 devices that were implanted, and that's just growing. Just 90, that number's gone up from 1993 to 2008. There was an increase in pacemakers of 96%. So this is a growing field, and pretty much every practice everywhere is going to need to know some kind of device, you know, have some kind of device knowledge. And then I have to include knowing what to report, because that's a super important part of the onboarding process and knowing, having a structured system. So obviously you want to know your device and the manufacturer and understand what the device is implanted for before you even walk in that patient's room. You want to definitely know if they have heart block. That would be helpful before you're going in and checking a device. Just, you know, basic knowledge, things like that, covering, just getting a full grasp of that patient picture before going in the room. Having a structured routine outline to, just for your own self, but to also report back to your provider or whoever you're giving your report to. So this is just a rough guideline on how I do my system in clinic. So I present the battery, the presenting underlying rhythm, percent of pacing, all your lead data, any events or therapies, AFib burden, any abnormal findings, and then obviously your settings. And then eventually, you know, it's fun to get to the part where you can actually optimize the device and make recommendations. And that is a really cool spot to get to. So there are definitely a lot of guidelines out there on what is appropriate to report and what you should be reporting. And then goals and skills required, you know, for this role, it's obviously going to be to interrogate devices safely. But like I said, also we want to optimize device function. That's a key part, because it's one thing to just interrogate a device. But if you can learn how to optimize and make our patients better, obviously that's going to be our goal. Background knowledge and 12 lead interpretations, having appropriate documentation, and then staying up to date with your policies and any device advisories. There's, you know, a lot of practices are good about keeping the clinic up to date on those, but it's good to expand your own knowledge on that as well. And then this is just kind of a rough guideline for the onboarding process and just sort of recommendations that I would have. And so when you're starting out with orientation, just making sure that you have, like I said, a designed, a designated mentor and a design set up for the allied professional coming in. And this can vary, you know, depending on what your background is before coming into EP and knowing that ahead of time so you can give better support to your allied professional. And so department welcoming and having a strong work culture and team building is obviously going to be super important. Having appropriate tools and training and resources and knowing what those are. There's several resources out there. I mean, there's Medtronic Academy. There's resources through Boston. There's resources that, there's a lot, but it's sometimes hard to know where to start. And so, you know, don't be afraid to ask questions and where you can get those resources. And so we finally get to the blueprint. So this is just basically a rough model that I designed to give you some structure in your clinic. This is basically a lot of how our clinic runs. And so we have our modules. We have non-patient contacts. So a lot of working with programmers before you even start working with the patient. Watching the rep or your device technician do the interrogations in clinic or in your hospital setting. And then a lot of handholding. A lot of doing the device interrogations with a rep or with your trainee. And then device interrogations with, you know, starting to get self-sufficient but still having the rep in the room. And then full autonomy. You go in the room. You do the device check. The rep's outside of the door but there if you need them. And then obviously a lot of systems have a, you know, a remote way you can connect with a rep as well. And then getting to full autonomy where it's just you going in the room and doing the device check. This is a sample onboarding timeline. So my role is a little bit unique in that. So I'm a nurse clinician. I do device checks but I also manage in-basket and provider schedules and a lot of other things. And so my orientation probably looks a little bit different than if you're just doing device specific. And so this is just a broad overview that goes through your set up there. And then this is just routine device care. Just so you kind of have, you know, you want to be up to date on what your timing is on when appropriate follow-up is. And I'm happy to share this with you guys. And then I want to just encourage you to expand, you know, grow in your role. I run the wound clinic at Duke and it's something that I really, really love doing. I love my job. And I'm really lucky that I get to work with some fantastic people. And we have a lot of, you know, nursing and working at the kind of the full scope of our practice and getting to do these device interrogations with patients. And so I do a lot of focus in wound prevention and things like that. And so I just want to get a quick, and then these are programs that are actually out there for the blueprint essentially. But like I said, they can be cost prohibitive. And so I just wanted to mention these. And then I want to, so our ultimate goal is safety. I want to, you know, challenge you to grow, ask questions. Don't be afraid to ask questions. And just take pause if you're feeling overwhelmed. And then I want to just get a quick overview for, you know, and some input from the audience on what your onboarding system looks like. And so this is just going to run through some quick questions and you can answer them and they're going to pop up here on the screen. Okay, so there's some smaller clinical practices out there. But I'm going to be collecting this data so I can have a better understanding of what other clinic practices look like and what your onboarding system looks like. But I really appreciate your time and allowing me to speak to you today, and I hope some of this was helpful, and I'm happy to answer any questions and give you resources. Thank you so much. We're going to save all the questions to the end. We'll have a lot of time for this. We'll just continue to move on with our sessions, and we'll hold all questions to the end. And in the interim, you can also put some in the app as well, and we'll get to them. Our next presenter is James O'Hara. He is going to be talking about a granular look at device EGMs. He is from Virginia Heart. All right. Yeah, the boring stuff, I've got some disclosures. They're not cool. All right. So, you know, the usual way to start these things, thanks to HRS for, you know, having this and giving APPs and allies sort of a voice and opportunity for this. And special shout-out to Monica and Brittany for letting me stand on the stage once again and bang my drum. I love EP. I've been doing it now for close to 27 years, and I wouldn't do anything else even if you wanted to pay me to do it. So my boring stuff, yes, I have disclosure. Really, what are we going to talk about today? So just quick high-level stuff. What's an electrogram? What do you need to figure out what the heck the electrogram is telling you? Does the device or the lead types matter? What do the markers and symbols mean, which this gets incredibly complicated today compared to 20 years ago when it was just atrium and ventricle, and now there's triggered response and PVC sense response. Here are some example cases, and hopefully we'll have some fun and you guys will have some tools to take home for the toolbox. So I'm big in machine learning and the AI space, so I thought it would be hilarious to say, hey, Google, what does an EGM mean? And ironically, it has nothing to do with electrophysiology at all. Apparently, I've been doing the wrong thing my whole entire career. I should have been in a stakeholder meeting. Clearly, not what it means for us. For EP purposes, it's just a recording of the electrical activity, either obtained through an EP study, from a device, whatever. It's what's happening at the horse's mouth, as I love to say. Right to the source, not what we see on the surface with an EKG, what's filtered out by all these other algorithms. This is straight at the source. And because it comes straight from the source, oftentimes the morphology trips people up that are new in EP because they're used to, well, on the surface it looks this way, but why does it now look this way on this electrogram? The devices make it really simple now. They tell you, hey, this lead is here and this lead is here. But you've got to pay attention to where it is. I've seen that happen a lot. What tools do you need, really? You need two eyes, one eye? If you wear glasses, you need glasses. And obviously, you know, whatever programmer, website, database, wherever it is, you're getting the information for you. Does the lead type matter? Well, the device type itself really doesn't matter, right? Pacemaker, defibrillator, the electrogram is the electrogram is the electrogram. The device isn't going to change the electrogram itself. Now, the leads do. Older leads back when I started, many of them were unipolar. Unipolar leads came with a whole slew of problems. You know, the myopotentials, my least favorite thing to deal with, that the bipolar leads sort of came in and fixed for us. And there are some companies, not naming names, that have much noisier leads than others. So what do the symbols mean, right? The devices, they give you everything that you need. It's a built-in cheat sheet to say, I think I see this, right? The computer is only going to tell you what it thinks it sees. It's not making any decisions. So with that in mind, I'm going to start with my first case. So this is a 65-year-old male who had significant sinus node dysfunction and recurrent syncope from sinus arrest and up to 25-second pauses. He got a dual-chamber pacer. And because in my area we're huge with Bachman's Bundle, his atrial lead was in the Bachman's Bundle. He got a conduction system lead in the RV, because why would we put it anywhere else? The EGM is so pretty. The EKG, the QRS is so pretty. And who doesn't like free synchrony? His post-op chest X-ray and electrogram from his post-op check is here. The leads are where they're supposed to be. The electrograms look like what they should. Now, post-op day three, here is his electrogram. So we have it set up. Everybody gets their device checked before they leave the hospital. We enroll them in their remote site that day, and we schedule a check two days later just to make sure the connection works. All of the various companies have a service that will call them, make sure the electronics get connected and whatnot. They'll call them a week later, but I'm obsessive about data, and I don't want to wait a week. So everybody has a check now about the third day. So this was his post-op day three electrogram. Doesn't look bad. Why is he going so fast? I don't know. Then, you know, get connected, called, made sure he got connected, had him send another transmission, and here is post-op day six. Something here ain't right. Now, when you look at this, some people will go, oh, well, this is super easy. Why is there two Vs for the first A? Well, that makes no sense. And then why is the V before the A, and then sometimes the V is at the exact same time as the A, which physiologically is impossible. So what happened? You get a better view from the lateral chest X-ray. So I saw the electrogram. We knew lead's dislodged. You got to put proof in the pudding. His AP view, you couldn't see the lead that was dislodged. The conduction system lead was just washed out. Oh, hey, look, yeah, I already knew it was dislodged. Thank you. So we got it repositioned, and fortunately he's doing fine. This one's going to get a little bit trickier. So this is an 86-year-old female with sinus node dysfunction, intermittent heart block and syncope, dual chamber pacer, again, conduction system lead. The operator who put this one in does not do Bachman's bundle pacing yet. I stress the yet. So her post-op chest X-ray, everything looks fine. The electrogram, unfortunately, wasn't saved post-op. You know, the beauty of the thumb drive is if you don't hit the button to send it to the thumb drive, it just stays on the programmer, and the programmers are set to I keep no information. So she got her usual post-op day 3, and it came in as an alert because something ain't right. And you look at this, and there's VV, VV, VV, which those of us that were around with the Sprint Fidelis are all having, you know, anxiety about SIC counts, and, oh, no, it's a Fidelis lead. Fortunately, it's a pacemaker. And so we got the chest X-ray, and clearly that lead is not where it's supposed to be. And the double counting was the tricuspid valve bouncing it back and forth. So she got a lead revision, and, hey, look, now everything's back where it's supposed to be. This one is a lot harder. Sorry. So this is a patient I saw in a clinic not too long ago. It's a 67-year-old male with complete heart block, had a VTVF arrest, coronary disease, two-vessel CABG, infarct myopathy, the whole slew of things, but most importantly he had an anoxic brain injury with his cardiac arrest. He got a bi-VICD implanted at an outside facility 10 years ago for secondary prevention, had a gen change in 2023. We have no notes about his checks from his other place. But fortunately, the remote site gives you, hey, here's all his remote checks from everything we have. So we knew, at least on a remote site, his leads showed no issues, there was no problems. And he had to come see me in the clinic for RV oversensing. And if you look at the electrogram, there is no funny bumps and squiggles on the RV lead to tell you it's oversensing. But if you know Abbott, they give you the little markers of something is here, but it doesn't tell you whether it's a V or a bi-V because it doesn't know what it is, but it knows it's there and it's not supposed to be there. So he came to see me in the clinic and this was his in-clinic check. And if you see, after the bi-V pace, now there's two hash marks and the device goes, I don't know what this is, but something's here. But you look at the electrogram, well, what the heck are you seeing? And there's a tiny little ditzle every once in a while, but it doesn't always see it. And so we reprogrammed the sensing vector to see maybe is this a canned coil issue and let's check from the tip to the coil. And no, it didn't fix it. The device still keeps thinking it's seeing something. And in all my years of doing this, this is actually the first time I had ever seen this, where the device is like, I see something. And I'm like, what? I don't. I had to call everybody. I called the rep, which for me is very unusual. And the rep came and said, no, there's nothing there. There's something wrong. Do isometrics. Nothing happened. Do this. Nothing happened. We called tech services who said, oh, send us the file. And they looked at it and said, no, it's an error. Don't worry about it. And because I was persistent, I said, you know, if the device thinks that there's a problem here, there's a problem here, and it's either we fix it today or we're going to meet this patient in the ER at some point and have a much bigger problem to fix. And I'm very cognizant of he already at his age had a horrendous anoxic brain injury, such that he has a permanent caretaker that brings him everywhere. He's not really communicative, and his whole outlook is, all right, yay, great, ah. So we decided the device keeps saying the RV lead is a problem, so we extracted it, gave him a new lead. We sent the lead out, and I got a follow-up email about a week after from one of the engineers that the lead was halfway fractured. Not fully fractured, but halfway. Sort of like those of us that are PAs and MPs, like a green stick fracture in a kid. Enough that the device would see a signal, but it was below the filter trigger for this has to be a VS, but it was high enough that it would give us the hash mark. If we hadn't been persistent and trusted the electrogram, this could have ended very catastrophically because he has nothing underneath. So this one's a little bit more fun. So 66-year-old male with gross sinus node dysfunction, periods of sinus arrest, gets a dual-chamber pacer. He's been in the clinic twice before I saw him with complaints of funny heartbeats and palpitations. He came to the clinic on the third time, actively having his symptoms, and here is his electrogram. So we all know the A should come first, not the V. So we got an EKG, and he was having periods of accelerated junctional rhythm, and if it wasn't for the fact that he showed up having symptoms, the device is never going to catch this, ever. So this is where persistence pays off. Oh, no, I have another one. Another one. This one's even more fun. So this is my favorite kind of patient. He's a mechanic, got ICD for secondary prevention. He was working on a car, gets shocked. Here's his electrogram. That's a whole lot of something ain't right. It goes on. He's getting shocked. And then I said, hey, so you work on cars. What the heck were you doing? There you go, right? The reason why the device companies all say, hey, no welding, is because of that. And he figured, because TIG welding is a little bit different than MIG welding and wire welding, he figured, oh, it's far enough away, I don't have to worry about it, except for, well, you have to get pretty close to make the sweet dimes. Any questions? Thank you, James. It's my honor to introduce Dr. Rick Vakil. He is from Johns Hopkins University, and he'll be talking to us about managing advisories, recalls, and lead failures. Do I press start? Yes, it's starting. There you go. Very good. Thank you, Monica, Brittany, HRS, for having me. It's a pleasure to be here. Again, my name is Rick Vakil, and so we'll go ahead and get started. So a little bit of outline for the talk. We're going to talk about why this matters, what we're dealing with, what we're dealing with when we see these advisories, recalls. We'll talk about detecting issues early, triaging these patients, and delivering appropriate management, a couple real-world examples, and some common pitfalls, fixes, and takeaways. So CID recalls are common. Some of the studies estimate that approximately 40% to 50% of patients with ICDs will be affected. The reality is that most of these devices don't fail, but in the select few that are high-risk, the circumstances can be quite severe and fatal. And we also have to measure it with the management and the interventions. So things like generator changes, extractions come with complication risks, so we have to really use a stratified approach for these patients. So as I mentioned, most of the recalls happen in ICDs, but pacemakers and CRTs are also affected about a third of the time, leads less so, but still happens. What are the most common types of recalls? So the most common problem we see are battery problems and incorrect therapy deliveries. And less commonly, we see some software issues within these devices. So it's important that the allied professionals are on the front lines of detecting these and managing these. And so with this, I'll give some relevant definitions. Class one, recall. It's a product that could cause serious injury or death. Class two, something that may be serious, maybe causes temporary illness. Class three, something that's unlikely to cause any major issues. So an advisory is a manufacturer alert about increased failure risk. The device can continue to be used. Recall, it's a FDA or manufacturer action to address a safety concern. And then lastly, a lead failure, it's an actual issue with the structural integrity or an electrical issue with the lead itself. So important to understand that not all advisories mean that you have to act on it, but we do need to investigate and figure out what we have to do for these. So detecting issues early is important, and there's a few ways to do this. First is the FDA notifications. There's a couple sites, MOD and MedWatch. There's also the manufacturer field safety notices. So mainly we hear of these from our reps and by emails. And lastly, HRS also has a resource, the HRS safety alerts. So all three of these things are good to sign up for, just so you can be aware of what's coming. And then I think reality, what happens is that we get remote monitoring alerts. We're looking at these every day, and those are the first red flags that we get, and that's the unexplained lead noise, the rapid battery depletion, or output changes. And so it's important to have clinic systems in place where we can maintain a searchable inventory of all of these devices. There are model numbers, there are CLN numbers, and it doesn't matter what you use, Pacemate, Merge, et cetera, have something in place or have an Epic list in place for the smaller clinics or the individual vendor dashboards. And then I also feel like we have a duty to report these issues. So if we're seeing something that looks funny, report it through MedWatch. So as data accumulates, this can translate into a national safety notice. All right, so let's talk about triaging these patients. So let's say through one of these websites or the manufacturer, we see that there's an advisory or recall coming in place. Next thing we have to do is identify the affected models, what the actual failure mode is, what's gonna happen, what did the manufacturer recommend we should do for this? Then we identify our patients. So using the list, the vendor list, et cetera, we figure out who's gonna be affected as a part of our clinics. Cross-reference the CLN numbers, look them up, and figure out and generate a list. And you can use these lists or you can ask your vendors to tell you which one of these patients from your clinics have been affected. And the next, importantly, is stratify. So figure out who are the high-risk, medium-risk, and low-risk patients. So the high-risk may be those patients who are the device-dependent patients. They have a history of therapies. We're at that high-risk of therapies. The medium, moderate-risk, not device-dependent, but they may be at risk. And of course, low-risk, they have a redundant system. So for example, if there's a lead recall and they have both an RV or a CS lead, they have a redundant system. They're gonna be okay. Otherwise, they have stable trends or a distant implant date. And then lastly, once we identify who's at risk and stratify them, we act on it. Have a structured plan in place. Prioritize the in-person checks for those who are high-risk. Get frequent remote checks for those intermediate-risk. And monitor those who are low-risk. So just some practical tips. I think importantly, it's important to know how to actually approach these patients when you talk to them over the phone. So the first thing that we should do is notify them early. Even before you have the complete details in place, let them know, hey, we learned of this. We're looking into it. Your device is under an advisory. This is not an emergency. We'll let you know as we gather more information. And then it's also important to tailor these messages based on their risk profile. So for those high-risk patients, we can tell them, look, we're gonna schedule you for an in-person check this week or next week. For those low-risk patients, you can let them know your device is working well. We'll increase your remote checks and go from there. And then lastly, document all these things. Document when you contacted them, what you discussed. Document their understanding and what the plan of action is. And we do this using templates, standardized phrases across the clinic to reduce the risk of missing something, a detail. Okay, a couple real-world examples. So case number one is the Boston Scientific EL Battery Advisory, managing the safety mode risk. So these were pacers implanted pre-2018. And the issue is that there's a high battery impedance that causes rapid depletion of the battery. And the device enters the safety mode. That's VVI 72.5, no rate response, device is unprogrammable. And in fact, there were two deaths reported in pacemaker-dependent patients with this advisory. And so the management strategy here was, one, identify who's at risk within your clinic. And then triage, who's the high-risk, who's the dependent patients, or near ERI. And those who are high-risk plan a prophylactic replacement four years or so before depletion for those patients. Increase remote monitoring frequency for the moderate to low-risk patients. And then for those who are in this safety mode, replaced immediately. Case number two. So this is the Medtronic ICD-CRTD recall that we saw when there was no or low energy shock delivery. And these were devices implanted between 2017 and 2023, mainly the chrome and cobalt devices. And that was a glass feed-through defect. And what happened is that through short-circuit protection, that was inappropriately triggered. And the consequence of this was there was a low or no energy shock delivered in patients who had VT or VF with the AX to B configuration. Management strategy here. So actually, there were no device X plans recommended. We reprogrammed all affected devices using the B to AX configuration. And we prioritized patients who had prior shocks, were high-risk of VT, VF, had NSVT, et cetera. And we verified programming at every device follow-up. And we educated those patients to let them know that, hey, there is a recall. It's a particular issue with this one vector the way it delivers therapies, but we've reprogrammed it using a different way. And lastly, lead failures. So when do we monitor versus intervene? And the common issues, of course, are insulation breaches, conductor fractures, or noise over-sensing. And the historic recalls are, of course, the Medtronic Sprint Fidelis with a high fracture rate, about 2% to 3% per year, and the Sanger-Riata lead, which had externalized conductors, over-sensing. And so here, in any of these lead failures, we have detection clues. Mainly, we're picking these up from our remote monitoring. Intermittent high impedance, over-sensing, or inappropriate shocks. Noise artifacts on the EGMs. Look for those initial red flags. And management options for lead failures. So if they're stable, asymptomatic, you're intimately picking this up, it may not require a lot. It may just require more frequent, close monitoring. If patients are at higher risk, you should consider a replacement with or without extraction. Otherwise, as a bridge, while we await that decision or management plan, we can use noise reversion settings. We can adjust the sensing vectors as a bridge. And of course, I think, in this instance, shared decision making is the most important, because frequently we're having conversations about extraction risk and gen change risk with these patients. So some common pitfalls that we see and how to avoid them, and some quick clinical fixes. The number one thing is delayed notification. Causes patient anxiety or harm. So I think still it's important to communicate early, even before the final plan is set. If there's missed patients from outdated records, so we have incomplete lists, I think that's a big pitfall. So it's important to maintain updated records for all of our device patients. Underreacting versus overreacting. So again, structured algorithm. Triage them and balance the failure risk versus the actual interventional or procedural risk these patients may have. Inadequate documentation, so that's a huge medical legal risk. And so again, way to get around this is templated dot phrases. Record the contact plan, understanding. And then lastly, something we don't always think about is uncoordinated vendor workflow. So we may have a predominance of one vendor type over another, but we need to have the same structured approach, regardless of the type of vendor. Needs to be vendor agnostic. So what do high-performing clinics do well? Anticipate, act early. Advisories and recalls are inevitable. They're gonna happen. We have to remote monitor. That's your first alarm. Identify these patients, inform them, and intervene using a stratified approach. Match your intervention with the risk profile of these patients, standardized across all vendors, and protect the patients by document to protect your clinic. And that's it, thank you. And next up is Courtney Jeffrey. She's from Kansas City Heart Rhythm Institute, and she'll be talking to us about the role of the allied professional within the remote monitoring clinic. I guess it's closer to lunchtime, the talk right before lunch, right? So I'm Courtney. I've been an EP for about 20 years. I work as a nurse practitioner. I'm going to talk to you about the role of the allied health professional within the remote monitoring clinic, more towards where it's trying to onboard and training. I mean, I think we all know, everybody in this room understands how essential allied health professionals are to remote monitoring, because we are the front lines, you know, to making sure that patients are, you know, quickly assessed and seen, and things are addressed way quicker than they were, you know, even five years ago. For the relevance of this talk, I have no disclosures. Okay. So we have different, and you know, as Casey was saying, we have very different types of allied health professional roles that play a crucial part in taking care of our EP patients. Some require more advanced technical training, like our device nurses and our device techs, and then we have more that require more advanced understanding of the clinical concepts and data that the CIDs provide, but they don't necessarily need to understand all the specific technical aspects. You know, for example, you know, your nurse practitioners, you know, your physician assistants, your clinic nurses, as I said, all are invaluable in helping us facilitate providing great care to our patients. So you know, one of the things that I found very overwhelming was just the amount of devices that were out there, and not only do you have ICDs, you know, pacemakers, ILRs, but you also have different types. You have single chamber, dual chamber, you know, CRTs, and you have devices that are there that don't really do anything except protect the patient, like a sub-QICD. So you know, this, at first, it can be extremely overwhelming. Then you have multiple vendors that have these devices. So within that, you know, not only do you have the complexity of the different types of devices, you know, the different manufacturers, different programmers, but the reports and remote monitoring are all different, too. So one of the things, you know, I find extremely important is to start with, for the purpose of this talk, I'm going to talk a little bit more about the clinical side of remote monitoring versus, you know, the device techs. So for the, you know, one of the things I do right off the bat is, you know, always making sure I identify the things that are the same thing and making sure they know where to find those. For example, where on the page does it say that they're A-paste, V-paste? Where on the page do I say that they've had this many episodes in the V, you know? So there's different things that, you know, I try to show them right away. These are the things that are exactly the same, it's just that's where you're going to find them. You know, so we talk about, you know, putting people onboarding, you know, and there are a ton of formal education programs and vendor resources to help train. You know, we have ATI, AME, PrepMD, we have High Rhythm is 365, we also, you know, have different types of, you know, programs that help people start with telemetry and dysrhythmia, you know, so that we can start that before we even do device. So I strongly believe that, especially since this is such a complicated thing, but it's an amazing, great thing to be involved in, is that we have a clear orientation plan regardless of if they're being trained to, you know, do the technical aspects of the device or help with the clinical side. We need to have them start with some knowledge of cardiology and dysrhythmia before we even start, you know, introducing device and remote, you know? And then ensure orientation plan includes ways to help the trainee feel engaged. The people that are most passionate about EP are the ones that understand how wonderful and how many ways that we can, you know, protect the patient, you know, provide them care before anybody else realizes that there's something wrong, including the patient. So, you know, so I feel that that is essential. You know, part of my orientation plan always includes case studies, you know, so they understand that there's a real patient behind that device, there's a real patient behind those rhythms that are going on. You know, and the other thing, too, is if somebody comes to me and they're, you know, and they're asking me about a patient issue, the patient keeps calling, you know, they keep saying their heart is racing, they won't stop calling. One of the things I do is I'm giving them some objective data to say, yes, you know what, they're right, their heart is racing, you know? And that helps them also, you know, believe, but also they get engaged and like, oh, are they on remote? They're looking to see if they have a device, you know, because they know that those tools are going to help us take care of the patients better, you know? And then also teach them how to not look at the very specific things, but also just teach them how to look at their overall data to help advance the care of that patient. You know, as we stated, there's a lot of complex data that comes with CID management. There are a lot of different things and obstacles, you know? But start simple, you know? I mean, some of these new trainees, they have never even been in the world of any type of device. Is it a pacemaker, a defibrillator, or an ILI? What's the purpose of it? Is it to pace? Is it to protect? Is it to diagnose? Is it to help them with their heart failure? Teach them how to look at overall trends. I think that, you know, these reports are very, you know, intuitive. I mean, like, you don't have to know all of the complexities of even, you know, rhythm issues or anything if you start here, you know? And like I said, you know, I feel like, you know, if you start simple and you can correlate that with a patient, you know, then they're engaged. And then the next time they come to you, you can teach them one little more thing. You can teach them, you know, I'm a big believer in it takes, you know, it takes five times for a person to be exposed to something, for them to really get it, you know? Each time you give it to them, they get 20 percent more of that information, you know? And then they're able to build on that, you know? I always let my staff come to me and nonstop ask me questions, you know, because it's an opportunity for me to show them one more thing. You know, one of the things I love is the patient calls, you know, does the symptoms even correlate with an event, you know? I mean, one of these, you can see here, you know, she's short of breath, she's got chest pain, and it's sinus rhythm. You can tell from the plot graph, right, like, you know? And this one is obviously, like, it's really fast. There's something going on. This person has PBCs. So even though it doesn't, you know, correlate with an arrhythmia that would have been, if you look at the micros, or you look at the EDMs, you can see that there was something going on. One of the things that I do is I have different algorithms and protocols for different types of events. Like, if an alert comes in for someone who was shocked, if an alert comes in for someone on AFib, and I feel like this is sometimes the best way for new staff to process the information so they're not overwhelmed, you know? For example, and it also provides a huge valuable time saving for me if the nurse has already assessed, the device tech has already assessed some of these things, so I don't have to dig through the chart so I can give them an answer quicker to take care of that patient. Some examples we use is, you know, atrial fibrillation evaluation. You know, the device has reached ERI or RRT. And then, you know, ventricular high rates and non-sustained, you know, VT evaluation. Okay, so for example, you know, a remote transmission is received for six hours of atrial fibrillation. The first thing I ask them is, are they on anticoagulation? Do they have a watchman device? Do they have an amulet? You know, are they currently on an antiretroviral drug? Are they rate controlled? Is the patient symptomatic? If they can answer these questions, you know, ahead of time so that me as a provider, I can go in and I can easily make quicker decisions so that we can get that, take care of that patient faster. Non-sustained VT, which is one of those ones that I love because we're always like, when is it really worrying, especially if it's on a pacemaker? When do we have to be worried about this, you know? So the first thing I tell them is like, what does the echo say? You know, is the echo so their EF is bad? Do they have real bad structural abnormalities? You know, what was their last stress test? You know, have they had labs in the last six months? Do they have any electrolyte abnormalities? And then, always, always, were they symptomatic? Because if they were neosyncopal or they had syncope, that is going to be a different story than if they were completely asymptomatic. This is one of the ones I love, you know, because it shows a partnership between the device people and it shows the clinical people, as well as gives us the opportunity to impact the patient care, you know, in the future, to make them feel better. So obviously, we all know that studies show that there's a significant increase in infections every time someone undergoes a generator change or a device upgrade. So when a device, when a patient's generator reaches EOI, a full evaluation of that patient should be performed, as well as their clinical status, because it gives us an amazing opportunity to take even better care of this patient. So there are several considerations that should be taken into account. What's the patient's age? I mean, if they're 99, I'm probably just going to say plain old generator change, right? But if they're 85, you know, or younger, then, you know, this is a different thing. It's also, you know, how do they look? What's the quality of life? So then you're looking at the underlining rhythm, because obviously, you want to know what the IV pacing percentage. This has gotten a lot more tricky because of conduction system and left bundle branch pacing. So what's the 12 EDKG? Look at still how wide the 12 EDKG QRS is, you know, and that's a different story. But it's something to keep in the back of your mind. Go ahead and put down their pacing percentage, because I'm going to go and I'm going to look to see what the EKGs have been set. You know, the lead function, you know, is it sensing? Is it pacing appropriately? You know, does it have, you know, high impedances? How many numbers have been currently implanted? You know, because if you already have four leads implanted, then you obviously are going to want to extract if you're going to add something. And is it under advisory? And then LV function, neurocardiostation class, current or prior history of heart failure, you know, all those things. So in summary, remote monitoring is an invaluable tool to help facilitate providing the best patient care. The allied health professional provides crucial, you know, crucial role in helping us provide comprehensive care. And we can use case studies and applying the data to real patient scenarios to help keep trainees engaged and want to learn more. And then utilizing algorithm protocols can help provide clear guidance and decrease the feeling of them being overwhelmed, as well as provide invaluable information to the providers. Thank you. Devicetech is ultimately, their training is device-specific. In our clinic, we do four vendors. I think most clinics do, but I do know of clinics that are specific to one vendor, so Abbott, Medtronic, Boston. So our Devicetech will go in the room, they will check the device, and then they give the report to the provider, or to the nurse, whoever's working with the provider that day. And so their training is just solely devices, and so their training looks a lot different than ours. As an RN, my role, and I know there's roles out there where the RN does just solely device checks as well. Ours is a little bit more comprehensive, where we have, like I said, we have the in-basket side, we have the provider management side, plus we go in the room, we manage their devices. I stay on top of remote monitoring. I know our patients very, very well, so I'm able to stay engaged with them. So I would say our role in our clinic is maybe not a unique one, but I think it is a little bit more unique and a little bit more comprehensive. And so our training is a little bit more extensive, as opposed to the Devicetech that is coming in the room. But essentially, the main difference is the Devicetech is there for support for all of our providers. And I mean, there's days where if I need additional support in clinic, I can just ask the Devicetech to come in and help me out. And so it's crucial to have, if you're a high-level functioning clinic and you're seeing multiple, multiple patients a day, having a Devicetech that can be there to help with the APPs is crucial. I hope that helped answer that question. Thank you. All right, this question is for Rick. Does the RIATA lead still have the recommendations to fluoride annually? Yeah, I don't think so, but I don't know if you guys have other, yeah. So when the recall was first announced, it was you have to fluoro it annually, and then as it got updated, it was you don't have to fluoro it annually anymore, but every single generator change, you have to inspect the entire length of the lead that is outside of the vascular system, and at least in our practice, we found two Rheada leads who had totally normal x-rays. We did their generator change, and whoa, there's no insulation here, but yeah, they got rid of the x-ray because it was a whole lot of extra radiation for very little value. Other question, I think this is James, your case. For the case of the patient with symptomatic AV asynchrony, what did you do, if anything, to minimize their symptoms? So in general, right, accelerated junctional rhythm where the AV junction's going faster than the sinus node, it's not going to kill you dead. It just makes you feel bad, and just like I tell all my AFib patients, hey, good news. You're going to feel bad when you have it, but not the threat to the longevity. It was really a risk to benefit discussion. For us to set his pacemaker to outrun his AV junction, he would have had to have a lower rate of 90, which is never appropriate for anybody at his age. We have a couple of 90-year-olds who have a lower rate of 90 because of severe symptoms with any rates lower with orthostasis, but in his case, it was a juice not worth the squeeze at the lower rate, and I said, all right, look, we can try a beta 1 selective beta blocker, so, you know, Bistolic or Atenolol at an incredibly low dose just to slow down your AV node a little bit, or we can just leave it alone, and he was so symptomatic with it, he was like, nope, I will take all the drugs you have, give me extra drugs. We put him on 2.5 of Bistolic, and he's had zero issues ever since, and he just ran like a half marathon with no problems, so it worked very well. All right, this one is for Casey. What guidelines slash resources do you use or follow for wound care? Yeah, that's a great question, and actually it's something I'm actively working on to get my next project is going to be a more streamlined, hopefully published set of guidelines for wound clinic practices, because that's something that we all need, but there's, I mean, there's various resources, I just did a lot of research on, there's a lot of articles on there about best practices of, a lot of it is on follow-up and how soon we should be seeing these patients. That strictly is 2 to 4 weeks is what best practice is, and that can be difficult depending on clinic schedule. I mean, if your clinic schedule's tight, it's harder to get patients in at times, but we have two nurses in our clinic that run our wound clinic, and so I see patients on a day, and then our other nurse sees patients on a different day, but there's just a lot of publications out there that we utilize, and we have a very streamlined process at Duke, but I would say we don't have an official document or guideline saying this is what's appropriate. We know it, we've done the research for it, but that's something I'm working on getting out there for everybody. Next question, when reporting non-sustained VT, high V-rate events, what is your threshold for beats duration to expect your device tech arm and to report? Sabrina, you're in the audience too, we just had this remote monitoring focus group, and this probably took up the majority of our time, James was there too, but from our, everybody had from four beats up to 30 beats, but I'll give this one to Courtney. So I usually do about four beats, but the other thing too I'm looking at is I'm looking at how many they're having, because if we've looked at the last four pacemaker checks and they've had four runs from four beats, I'm just like, okay, just call the patient, make sure they're not symptomatic, and then I'm always making sure, have they had a recent echo in the last year, I mean, no matter how much. So a lot of it is really patient-specific, I mean, if I've seen that a patient has had, let's say that their EF at one point was around 40% or 35% and we've optimized their goal direct to medical therapy and it's come up, and now they're still having runs, I mean, my threshold for that is a lot less. So I can't give you any specific things, and I think that it's provider-specific, and I go to one physician and his threshold's way higher than another, so I think a lot of it too is about being comfortable and how will the patient feel, what's the risk? So, yeah, this is a can of worms. So our clinic does something similar, but what we do is actually we have a grid and we stratify based on 10 beats, whatever, pick a number, but 10 or 10 and or recurrent or greater than 10 beats, and then also further stratify based on EF, mildly reduced, moderately, of course, if they're severely reduced, they need to be evaluated for an ICD, and then we look for symptoms, and then we have a stratified approach of whether or not we start beta-blockade or not, and or do we need ischemic testing in labs if they haven't had it in the past six months. Penn's very similar to yours. Yeah. All right, and this is our last question. It's for Dr. Vakil. Advisories and recalls and patient notifications, do you notify everyone your clinic implanted even if they are now followed elsewhere or only those you currently follow? We make sure that they've had handoff to whatever center they're going to. That's absolutely crucial so no one falls through the crack, and so that's number one. We do notify everyone. We use a standardized letter or call or whatever, and we notify everyone and we call them. As long as they're a part of our clinic, if they haven't been officially transferred over, then we still notify them. This was a great session. We thank all of you for coming and staying. I say take advantage of the AP lounge, go to the APP luncheon, and continue to have a great time and enjoy San Diego. Thank you, everybody.

Heart Rhythm Society 2025

cardiac implantable electronic devices

CIED management

allied health professionals

electrogram analysis

device recalls

remote monitoring

patient care

multidisciplinary approach

technology in healthcare