Good morning, everybody. It's my pleasure to welcome you to 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 HRS 2025 mobile app from your preferred app store. This is how you can participate in live Q&A during sessions, including this one. And then please scan the QR code on the screen to access this session's Q&A, but we will also ask you to come up to the mic to ask your questions as well. When using the mobile app, log in with your HRS credentials. Please note that visual reproduction of Heart Rhythm 2025, either by video or still photography, is strictly prohibited. My name is Ruby Sandhu. I'm from the University of Calgary, and this is my co-chair. John Cantanzaro from East Carolina University. We have an exciting session planned for the next hour on optimal device clinic design. The format is a panelist discussion. The first half of this session will be a discussion on in-house healthcare system management. Our panelists are Rennie Mullins from Carriant Heart and Vascular, and Jesse Pestilos from Vizient. And I just wanted to direct the first question at both of you, which is to just tell us a little bit about your role in the device clinic. Do you want to go first, Jesse? Yep. So my previous experience in device clinic, I previously worked at Geisinger managing their device clinic, and then for 10 years at Piedmont, I managed their EP program. Currently now, I work with Vizient where I help EP programs decide whether cardiac remote monitoring services is something they should pursue. I manage the cardiac device clinic at Carriant Heart and Vascular in Northern Virginia, where we do implantable devices, as well as my device clinic also manages all of our ambulatory monitors. Great. And maybe you each could expand on the workflow in terms of remote monitoring in your device clinic. At Carriant, we have a team of nine technicians, both comprised of teletechnicians as well as cardiac specialists, and the team is split, so we kind of manage both the ambulatory monitors and then I have a few technicians who do our implantable devices. Most of my technicians all work remotely, so every day, logging into the portals, pulling the reports, uploading them into the EMR and sending them to the doctors. We also manage all the alerts every morning, calling patients with check-on symptoms and then forwarding those to the EPs as needed. So during my time at Piedmont, we had a customized workflow for our device specialists and our teletechs who were looking at remote monitoring. So basically, the device specialists would look at the alerts. Any routine device checks would be read by our teletechs and they would be triaged out. But we had multiple clinics throughout Piedmont, throughout Georgia, so it became overwhelming at a point of being able to look at the alerts every day as well as trying to triage them. We also had at one point heart failure, wanting to help with those triaging of the heart failure reports to them. So at that point, we decided that we needed a different solution because even trying to customize workflows wasn't working for us at that time. Were there any hubs around the main Piedmont area that you had to sort of either feed information into or have bidirectionality in processing, say, a remote clinic or an outreach clinic? And was there an opportunity to build a clinic at one of those outreaches that fed into the major Piedmont? So the main clinic was at the Atlanta location where we did remote monitoring for all the satellite device clinics. So any device reports that came from different locations, we were looking at those device reports and then we would triage them appropriately to the physician they were following at those different sites. But again, the routines were not as cumbersome. It was the alerts that we were getting every day that were more cumbersome. And I just wanted to expand a little bit on that because both of you mentioned managing alerts and I wondered about the approach you took to identifying alerts that you felt were actionable and how you came to decide on that approach. Was that through a stakeholder group, the device clinic nurses, the techs, the EPs? You know, how did you approach dealing with, I'm sure, what is an overwhelming workload when it comes to alerts? At Carrient, we developed, with our two electrophysiologists at the time, we developed a stoplight protocol for our alert system and we basically just set up each of the portals to adhere to that stoplight protocol. That way, when a red alert comes in, it does text after hours so we get that alert after hours to address as well. But any yellow or basically green, normal alerts, chronic AFib patient with an AFib burden, we're going to turn that off so we're not dealing with those daily. Yes, during my time at PVOT, we set criteria for alerts. It was a collaboration of the entire team for EP physicians and determining what that criteria looked like when trying to triage to them or triage to our EP nurses or triage to our device specialists. So we came out with workflows that helped triage certain type of alerts based on the criteria that was set by the physicians. Pretty much that was how we set our processes there. I think it's really interesting how you said that some alerts went to the nurses and then some went to the physicians. Do you remember how you decided which alerts would go to who? And then, Rennie, I wanted to ask you if you remember what you classified as red alerts. So maybe, Jesse, do you want to talk a little bit about which alert went to which provider? Yes. Basically, the nurses would look at any type of alerts that we would have symptomatic episodes with the patient. So if a patient called in and sending in a transmission and there was symptoms associated with it, that would be seen by the EP nurse. And then from there, it would be elevated based on whatever the conversation was with the patient and the nurse. If it warranted a physician interaction, then we would involve the nurse as the next step. I mean, sorry, the physician as the next step. Our red alerts are shocks delivered, any RV, LV, RA, impedances out of range, things like that, which we, I mean, I'm sure a lot of places have some patients that have chronic impedances out of range on certain devices and stuff like that. So we get to know our patients really well, which is really great, too. But yeah, we just address those as needed as they come in. So those were your two main red alerts? Anything related to battery? Oh, yeah. Yeah. Just like, I believe each of the device portals have like, they set some red alerts. So most of those, we kept the same and we just handled them as they came in. And how did you manage the volume of the alerts? Because in my experience, there's sort of a continuum of a remote device clinic. So this is more a question for the group, but when you came to your institution, how rudimentary was your device clinic? At what level? Was it an infant? Was it a toddler? Was it an adolescent? Because I think we can all learn something from walking into a computer with an Excel spreadsheet and patient names and dates on it. Yeah. No, absolutely. I actually started in our device clinic at Canyon. I kind of built it up to what we have now. We started with, probably about five years ago, with 1,500 patients and we've doubled that now. But just one, having our two EP champions that we do have in our practice has been monumental, as well as having the cardiologist be really great when it comes to physician follow-up and stuff like that has just been a huge help within our practice. So we have a lot of support, thankfully, and our device reps and everything are really supportive as well. So when I came into the device clinic, it was really early on. Piedmont had just acquired different private practices for EP groups, cardiology groups. So really, it was getting, one, the team to collaborate with each other and come up with workflows and protocols that work best for our needs and remote monitoring. So we really started from infant phase of trying to figure out, again, what needs to be triaged, how are we going to look at these reports, reports that were done at these different satellite clinics. Would our EP docs be the ones who read these reports or would it be the cardiologists at those locations? Ultimately, we decided EP would. So there was different aspects that we had to look at from the very beginning. Also trying to establish the device clinic checks versus the remote checks. So there was a lot of work in the beginning of trying to establish those foundations. Was there any option from the administrative level to leverage an outside source or an agency to help say, I mean, in my mind, there's three tiers. There's the physical personnel, there's the remote monitoring, and then you want to make sure you're capturing everything that needs to be captured in terms of billing, whether it's for heart failure, whether it's for an annual check, or even just any time an interrogation is done. So I'm curious to see your experience, if you had any outsourced, I would say, help along the way. Because it's a big, it's a heavy lift. Yeah, no, it's definitely a big decision. So before we got to that point, I think some of the challenges that we had faced, so one was hiring device specialists and trying to get device specialists to come in. You know, we'd have device specialists for a certain period of time, they would find different outlets, like industry or working in the lab. And so that was a challenge for us most of the time, because then we'd have to retrain the new device specialists who came on, and then still be short-staffed, because our program continued to grow. So as the collaboration with our EP program across all of the sites, our patient volume became overwhelming. So at that point, and then especially when we started partnering with Heart Failure and trying to triage their reports over to them, and then trying to establish some guidelines for who would be reading those, what would come back to us. So at that point, it was once we, I had challenges of trying to get cardiac device specialists approved from administration. The next step was to look at what other solutions are out there to help us with the load that we had with our patient volume. And so the next step was looking at our remote monitoring solutions. And so there was a couple at the time that kind of vetted through and talked to and, you know, see what they offered when it came to device support staff help, when it came to the software, when it came to the EMR integration for the software. And so once we understood all the pieces that come with those solutions, we had to see what best fit our organization. And so at that time, having the device support help, as well as the software, was very beneficial for us. Yeah, there are so many nuts and bolts from creating a performer, figuring out what your return on investment is going to be, and then demonstrating that to administration. And then having them assign an IT or an IS group, that's then going to create internal costs. And then have the external costs of who you outsource. And then balance that, I would say, tightrope as you move along in the project. Because sometimes projects don't move as quickly as you want them to. And the longer you run that project, the more internal costs you start incurring. So I think those are some great points to really point out for anyone who is considering starting from scratch and building a remote device clinic. Or we have about 5,000 patients on our remote device clinic. No, and you're right. I mean, collaboration comes from IT, where the priority is for that project, to your point. And then talking to your billing team, and letting them know what we're about to do. And there'll be increase in charge captures that come through, and what they need to be looking at. Also, our heart failure team, letting them know that there was this new solution coming through, as well as all the satellite clinics. So there was collaboration across all disciplinaries to ensure that we had a successful solution that was implemented. Yeah, and you didn't mention keeping everybody happy all the time. So you'll notice, or at least I notice, that with IT and IS, they have lists of priorities. And they're waiting for their partner to fail, and then they're just going to move on to their next priority. So I think, I want to say, not hand-holding, but a little collaboration. But I would say a special type of collaboration where you involve either an EP or an APP in the processes that are on the calls with IT and IS goes a long way. That way, you can make sure that you have a Gantt chart, that your project's moving as the way it should be, and that you hit your milestones as you need to. And then, Rennie, what challenges did you face as you created this workflow? Most of our challenges is, like a lot of people, staffing. But the one thing I'm a big advocate for, I think because I was a product of it, was just having the background in reading EKGs and being sent to training to move up from there. And I'm a huge advocate with my team. I've trained three other technicians that way, sent them off to ATI to get the training they need to further their careers. I just want them to know that there's more out there than just reading EKGs every day on event monitors. But if that's what you want to do, you can totally do it. But we have other options, and a ladder you can climb to learn more. That's great. I know when we think about device clinics, we really focus on pacemakers and defibrillators, but we're putting in more and more loop recorders. And that can also be overwhelming. So I just wondered about your approach to dealing with implantable loop recorders. So at Carrient, we actually have an ILR implant clinic, which I also manage as well. And we average probably about 20 to 30 implants a month of loop recorders. We have about 1,000 ILR patients, and we're pretty strict when it comes to the alert management of those patients, and making sure that we're checking the alerts on time every day, addressing symptoms with patients, and getting those billables in as quickly as possible, but also having the providers sign off on them as quickly as possible so we can see that revenue in the long run. And before I ask Jesse to comment, what is the staffing for the implantable loop recorder clinic, and is that separate from the other devices? No, yeah, we use our device clinic staff to staff that, as well as our industry rep team. That's great. Yeah, so it was the device clinic staff as well. And that became overwhelming, the loop recorders, especially with the increase of those implants. A lot of it was false alerts that came through, so trying to read through those and figure out which ones were truly true alerts versus false alerts, and then which ones should get triaged. And we were getting those in every day from patients. Patients like to be click-happy, so there would be days where they have a scheduled remote check that's like, can you see if I sent it to transmission, and go to the website and you see 17 transmissions every 30 seconds, and yes, we definitely sent your transmission through. So, yeah, I think as a testament to that, HRS and Guidelines endorse a patient-physician contract. And at first, you think it sounds a little bit nuts, but you will have a patient that has AFib, and they will come in and say, why wasn't I alerted of my AFib? I'm at risk of stroke, and I need to be treated immediately. And it could be a Saturday or a Sunday, and there needs to be at least a document and a sit-down, a shared decision-making tool to really let the patients know that we're not 24-7. Have you run into that problem at all? Yeah. So we actually have, at our ILR implant clinic, we have a contract that the patient signs with the physician at implant, or like when they're signing the consent form, it just lets them know that we are not a 24-7 monitoring group. Just because we see events on your loop recorder, if you have a patient history of that and are on the correct medications, we are not going to call you for an hour episode of AFib. Now, if you only have paroxysmal AFib and you go, you're starting to go seven days of being in AFib 24-7, we're going to call you on that and get you in to see your provider. But we still get those phone calls. Why didn't you let me know I had this episode? Because you're on the correct medication. There's no point in making an extra phone call to do that. I think shocks were another issue, so we had to have a shock plan. So our shock plan was, if it's one shock and the patient's okay, you're okay to not bring 500 phones. If there's more than one shock, go to the ER, or if there's one shock with any hemodynamic instability or lightheadedness or presyncope, you're syncopated in the ER. Yeah, the criteria is like onset of new AFib, depending on the sustained time for how long it was lasting. That would be triaged as well as alerts for our patient population. We had more of a verbal contract, so our device clinic staff, after their implant, they would come in to do their post-check, and that's where we would let them know at that time what the criteria would be for calling them or alerting them of any of the alerts. I think managing patient expectations is such an important part of how we deliver care, and I just wondered if you both could talk about what is the approach to educating the patient? So prior to an implant, do you give them reading material? Is there a video about remote monitoring? Is there something afterwards? Is there something you give them just on an ongoing basis of how things are being managed? So it was two-part for us. We had education happen during the time of post-implant with the industry rep for whichever supplier the company belonged to or the patient had implanted, and then when they came in for their post-implant follow-up in the device clinic, we would have that conversation again because they could think it's important. You have it that first time after the implant, right after the implant with the industry rep. There's a lot of going on, so patients don't really understand the concept of remote monitoring at that time, but it's great to introduce them to that concept, and then when they come back for the post-implant device check, if they have any questions, their family members usually would be there with them saying, they're talking about this remote monitoring, what were they talking about? And then we go into our explanation again of what does that look like, having them understand, again, if alerts come through, what we will do on our end versus what they need to do if they feel any symptoms or want to send a transmission in for us to review. Yeah, when the EP or the cardiologist order an ILR implant, it goes directly to our hospital scheduling team or our implant scheduling team, and what they will do is when they send the pre-op information to the patient, we actually created pre-implant forms that go over what the device is for, what is remote monitoring. There's a huge highlighted part on the bottom that says this will be billed to your insurance if you have insurance, just letting them know so it's not a surprise bill that they're also getting. As well as at implant and at their wound check appointment, we're still going over education. I feel like education with these patients is always ongoing. For sure, I mean, I think the patients are the core of what we do and why we're there, and getting the stakeholders to buy in is very important, and it's not only administration but the physicians because we have all our radiologists who, if you don't have a policy for an MRI conditional or non-conditional device, you're gonna get 100 phone calls or the patients can get hurt or they'll just not get the care they need. So I just wanted to poll the audience, the show of hands, how many provide patient education before implant? So about a third of the audience, and I think I probably know this answer, but first follow-up, or right after implant, so before they leave the hospital, how many provide education? And how many wait till the first appointment? Great. Well, we wanna open up this first half of the panel discussion to the audience, so if you have questions, you can write them through using the QR code, but please feel free to come up to the mic as well. Yeah, we want this to be as interactive as possible because the more questions that are asked in the Q&A, the more questions that are asked, the more we'll take from this. And we'll also learn from each other, so one of the things I learned with dealing with the remote devices is to train the trainee, as was mentioned, and making sure that there is a QI that wellness is something that is maintained by getting an IBHRE certification as well. Because you can't just put somebody in a room and have them check devices all the time without ongoing emerging technology creeping in, and there's always something to learn, always. Hi, Josh Silverstein from Allegheny Health Network. Thanks for the great session. I work directly with CardiQ that HRS runs, and I think that a lot of what we're talking about seems like we can all come up with our own solutions, but I think the CardiQ platform is something where we can all share our different ways we've come to the same conclusions. I was wondering, how did you start the process? Did you collaborate with other people? Did you draw from information? And I guess the last plug, since I work with CardiQ, is if you can share as much as you can on there, and I encourage everyone in the audience that if you have algorithms, protocols, patient education materials, it's great to share them so we all don't have to reinvent the wheel, so thanks. Thank you for that. So when we tried to, or when we, in the beginning, tried to draft the workflow for the device clinic and the remote monitoring clinic, again, this was collaboration from industry, from our EP physicians, from the staff, from HRS guidelines, so we used all of those pieces to put our workflows together, and again, customizing it to what fit our organization, because not every organization has 17 satellite outpatient clinics that follow patients. So for us, we needed to establish foundational protocols for how we manage our patients through coming for in-clinic device checks versus remote device checks. Did you wanna add anything? Same process, just using the outside industry as well as our physicians. One of my, my CEO of our company, his biggest thing is do not reinvent the wheel, so we pull from everywhere that we're able to. So my question is on call coverage. When, I hear some do and some don't, what drives that decision? Is there a certain number of patients or a certain outcome, and has there been any, is there any data on patient outcomes with 24-hour call coverage versus not providing that 24-hour call coverage? That is a good question. I don't, I don't really think there's, I don't know if there is really any data, but we kinda just took a look at how many red alerts we're getting after hours, and what those red alerts were specifically, and kinda just based it off of that. I mean, obviously, you're not gonna catch every red alert that comes through, but to try and get those patients that really need it with shocks or anything like that and getting those addressed, we try and get those done as quickly as possible. Sorry, I'm not catching the statement. How do you pay for that 24-hour call coverage? So, they, my practice, they pay per alert. So, however many alerts that that person might do in a month period, they pay for. Yeah, so, you know, whenever people, I mean, there's no, no margin omission, so I think that the idea of payment is really important, and the 2023 HRS consensus document started sort of the snowball of to look at device, people work in the device clinic and establishing a ratio, and then sort of what that return on investment is going to bring, so you can then take it to your key administrator, your COO, or your CMO, and then have them allot some type of monies for this. So, there's something to keep in mind, and it's interesting that there's a lot of different ways different hospitals do things, in terms of payment, as we've just seen, but if you're rural versus an inner-city hospital, where I am, I have nine outreach clinics, and there's places where there's no self-service for 10 miles, at least, so what we're doing is we're working with North Carolina, it's NCTNA, it's the, they put fiber optics and hotspots in, and we're trying to gather monies from the state legislature to expand using a faith-based method. We're going to barbershops and putting those hotspots and just educating the patient, so it's digital health literacy, followed by training the trainers, so we'll bring one or two people out to that certain barbershop or the congregation where we go, and we're also able to check the devices and then bring that back for the next visit. So I think we have time for two more quick questions. Hi, thanks so much for a great panel. How do you handle patients who, maybe despite signing a remote monitoring agreement, unplug their monitors because they can't afford the co-pays or just can't do it? So for those type of scenarios or those patients, one, we would talk with them when they came into the clinic, try to understand what their situation is, whether that is they couldn't afford it or they didn't have connection to a telephone. I mean, there was all different type of scenarios, but if that was the case that they could not follow through remote follow-up, then we would have them just come into the clinic, and depending on if it was a pacemaker, defibrillator, we would set the frequency of when they would come into the device clinic instead of doing a remote monitoring. Hi, Amy Stefanski from Yale New Haven Health. I run the remote monitoring program for the system, and my question is, how are you keeping up with digital competencies for your staff? We've been able to utilize all of HRS guidelines, the calculator, we've kept up with staffing with help from administration, believe it or not. It's growing and doing great, bringing on new staff and educating patients, as you guys touched all the topics, but educating staff and keeping up with the digital competency with all the vendor sites, all the new devices that are coming out, is anybody doing anything specific? This is a great segue to the second half of external corporate management, so I'm gonna open it up to, we have special guests. We have, and please, if I butcher your name, don't yell at me, Matt Wilson from PrEP MD, Brian Faulkner from Pacemate, and then Leron, you have to help me with the last name. Me and Madonna have no last names, but I do. Okay, he's got a 91 life, so let's try to get their perspective on what they can do, how they can differentiate themselves, and how they can help us when we think we need that extra staffing need to reach out. Sure. So maybe each of you could just talk about your role at the company, and specifically any innovations in remote monitoring. Matt Wilson, CEO of PrEP MD. For over 15 years, PrEP MD has specialized in providing comprehensive solutions for a lot of the topics here, so to really improve patient care and address health equities, and so this is a topic near and dear to us. We do that through, I think someone just mentioned education through education, CU accredited education focused on device clinic staff as well as EP staff. We have a remote monitoring service team, IBH certified remote monitoring service team in addition to software and staffing services. So I think one takeaway is collaboration is needed, and I think I'm always loved panel discussions like this. I think getting providers, industry, and third-party support services is important to optimizing care. I think unique to us is we look to provide these in a flexible way. We reference something called a device clinic life cycle, knowing that the needs are fluid within a device clinic, and I think we've heard Remy mention staff, training shortages. We know that those are always changing, and working with partners, kind of taking relationships, less of a transactional relationship, more to strategic partnerships is what's gonna lead to better patient outcomes, both near and long-term. So we strive to try to provide that, and able to kind of dial up and dial back certain services depending on their given needs at that time. That's great, so I'll jump in. So Brian Faulkner, I am now the head of product at Pacemate. I've served many roles there, including COO and helping to move the organization from its co-founding all the way to where we are today from 2015. We're uniquely positioned to work with large-scale institutions and small scales from 500 patients all the way up to 50,000 patients. We have groups that are bringing in multiple clinics and trying to solve very deep problems and issues that are unique to their subset. Moving over to the head of product, I took that transition and step when we decided to make the move to bring PaceArt into our fold of products, as many of you know. And so Pacemate Live is looking at what the future of remote monitoring is really gonna look like through innovation and bringing those two subsets of products together, solving those unique challenges that you have in your institution. I'm Bleram Baraliou from 91Live, founder and CEO. I also run the theoretical division, which means the group that is working with mathematical modeling and models of AI to automate and improve both diagnosis as well as prediction. So when we started 91Live, we came from the point of conviction that there is a convergence of data science and technology that is changing every facet of human activity, except government and medicine, which are lacking massively. Wall Street was here about 30 years ago. And we started looking at different areas where we could make an impact in patient care. I was also lucky to be married to an interventional cardiologist, so I had some exposure to the problems that you all deal with, understanding that more than half of your time is spent as clerks entering data into EMRs. Doesn't matter if you have a PhD or you're an EP or interventionalist. So then we looked at the remote monitoring of implanted devices for two reasons. One, because it had a significant benefit, as studies showed, and it was vastly inefficient. And secondly, because it provided a very interesting opportunity to get clean data from the source, highest quality data from which you can build models to understand disease, in particular cardiac disease. And observing sort of where the market was going and what was happening, how the device clinics were being managed, we realized that pretty much everyone sort of had, realized there was a business opportunity, first and foremost, to create these third-party services that could help clinics, because clinics were overwhelmed and they could not put up with all the work. And they were building this sort of service teams, either reps from companies that serve as the EP lab or some of the device clinic nurses, EPs, APPs, and they created these service companies that ultimately realized that it was still overwhelming to handle all this data, so then they built some software to support it. So almost all of them were basically service companies with the technology to help them. And we wanted to do something different. Well, first of all, we didn't know a lot about service or almost nothing. So our target was really academic centers of excellence and institutions that lead adoption of new technologies, but they're partners in this journey. So we built a software and math modeling first, and actually Yale happened to be our first partner in their entire health system. So we worked actively to first build technology that can automate the collection of data, work with different, with the four manufacturers that provide this data for implanted devices in particular, and then look at our nirvana sort of was every single process that can be automated and captured by technology, and I'm not talking math modeling yet. Absolutely, that should be the first priority that should happen. That includes downloading the daily CGs for some clients, for example, that want to look at that for research purposes. It includes episodes that are missing. It includes data that typically device makers will not send, and you need to go to the website like ECG gain and so on and so forth. So this was the first path which we completed a couple of years ago for the most part to a large degree, and then we looked at what's the next step. When we talk about the future of the device clinic, the optimal device clinic, then it has to be such that first and foremost, the large health systems must be able to manage this internally if they so choose, as does Mount Sinai Yale, for example, but then some other systems where they don't have the synergies and fungibility of staff, and also depending on sort of ability to recruit, they need to be able to also outsource this to third parties from a service point of view, but as you know, we had a debate yesterday, and one of the points that was made is that really there should be an opportunity to choose your software platform that serves your purposes and then choose your service team that best matches sort of your protocols and the level of clinical support you wanna provide. So now, as we'll go through this discussion, maybe we'll touch on some of the points, but there are a couple of very important points raised, like how do you handle the alert overload? Well, I was looking at the data that we looked at across our clients, and something like 75% of alerts come from 10% of patients, and I think 95% of all AFib ILR alerts are below six hours, so then does it matter? But I think some of the topics that really I'd like to bring to this forum and maybe talk a lot more about is overnight and critical alerts. So everyone has the red, yellow, green. We've established a new protocol, REDD+, so after hours or at night, or even during the day for that matter, when an alert comes through, we classify this, let's say yellow and green, and that goes into the morning pile of adjudicating and then the service providers, and we do have service as well, because recently we acquired the team out of Ambucor that provides service. So half of our clients now are service, and the other half are clinics or health systems that do it themselves. So anything that's yellow or green, we will punt it to the morning team. And then if it's a red alert, then we have this whole adjudication process of what needs to be handled immediately and what not. And it's expensive, as you can imagine, but our service team, as Ambucor did, does provide 24-7 coverage. And then we've created this category of red plus. So I was actually looking at the table that we put together. What we're doing is we're looking at every manufacturer, every alert possibility for every device type and subtype, and then deciding which alerts are coming through. For example, a noise and a lead fracture, and I'm a mathematician, I'm not a cardiologist, so forgive me if I'm going into depths that are beyond me, but if it's a lead fracture presenting as noise, there is no alert from any of the manufacturers. But there are some manufacturers that show an alert that needs to be adjudicated, and then others for the same alert show nothing. I'm looking at this table, we're trying to create this comprehensively, so we decide what needs to be adjudicated, and then what is immediately critical. Like multiple shocks, you don't need to adjudicate anything. You need to call the patient right away and handle that, and so on and so forth. So I think it's critical for this discussion to move from what's the status quo, what are the challenges, how do I handle overload, and start with what is best patient care, and how are we able to create the framework, the platform, the protocols, and the efficiencies to be able to deliver that service, to deliver that patient care while being able to afford it. So whether that is because we're cutting costs, and we're able to do it at a price point that is measurable and comparable to what CMS is providing, or whether it's to establish the foundation of what is best practices, what are the benefits for the patient, whether it is through studies or other measures, and going to CMS and saying, you need to pay more for this. But I think remote monitoring of implanted devices, and then going into wearables as well as event monitors, is a critical field that can change the game in healthcare altogether, because it's the first beachhead for artificial intelligence, in cardiology at least. That's really insightful, and when I always hear artificial intelligence, I think about cybersecurity. This is an enormous amount of data that not only is being transmitted, but I assume can be hacked into. How do all of you deal with cybersecurity? So very good point you raise. We're actually building a post-quantum secure encryption, homomorphic encryption technology. We have something like 60 engineers in our staff. Some of them are Wall Street, some of them are Wall Street technologists, some of them come from data security. The idea is, first of all, data is not secure so long as it rests in so many private servers all over the place. It's hard to secure it in the quantum age for sure. So if you ask me, this is maybe a little bit premature, but our idea is that you need to ultimately move all the data into the cloud. So EMRs should not exist. There should be one cloud data lake or multiple distributed ledger databases that have the data, and then the way we're building the system, some of it is built, some of it is in progress, is if I run an AI algorithm that adjudicates, we're presenting three abstracts. By the way, you're welcome to come by the booth so we can show you what the AI models are showing in terms of detecting AFib. With just 1,000 patients, we're able to train a model that would achieve sensitivity and specificity in 90 to 95%. But the bottom line for encryption and security is that ultimately you need to build a platform, a framework where you send the algorithm to the patient data. It could be in their own PC for all I care, without knowing what it is, runs the algorithm, deduces the result, and brings back the result without ever decrypting the data. So the next level of security is mandatory because the problem, the reason healthcare lags so much, first of all, is there's a lot of conflict of interest and siloed sort of systems and practices. Less than 1% of data that's presented in research is available for audit, for example. I find that staggering. But if you're in Wall Street or any other field, I can try an AI algorithm, and if it works 55, 60% of the time, I'm making a lot of money so I couldn't care less of the times that you lose money. You cannot do that in healthcare. You cannot have an AI algorithm that works 80, 85% of the time, or even if it kills one patient out of 1,000. So that's why the level of threshold is much higher. You need explainable AI, and then you need a different level of data security. So these are topics that I think need to be broached. HRS is a great place for that. HRX, it's even more intense. I invite many of you that are interested in sort of what the future of cardiology looks like to attend that conference. We're big fans and sponsors of HRX, which happened in September this year in Atlanta. But these are topics that I think are very important. I think we need to stop talking. They're great topics. Do you have any? Sorry, I was gonna say, I think we need to move away from status quo and start talking about what the future looks like. I think it's back to collaboration, too. I think it requires more than just third-party software, IT, Epic, or the EMR, getting those folks together to kind of have these discussions, because you're right, the data sharing in general. I know they're sponsoring the Interoperability Forum. I think that's a good step in the right direction, and there's still a lot of work there to do. But back to, you mentioned research. Those insights are only gonna be as valuable as complete data sharing in discrete data fields. And right now, for reasons, no one's really incentivized to share that data, the proprietary data. So I do think that is a limitation on the research side of that. But yeah, I do think it comes back to collaboration. I do think there is SOC 2, type 2 compliance. There's government agencies. Obviously, that is kind of table stakes. But I think taking that further, working directly with IT, things like pen testing, things like that are all important. But I think that comes down to, once these integrations are in place, you gotta make sure that they're secure, and that any updates are done in testing environments to where no patient data is compromised. And I think we should all be held to SOC 2, type 2. It is table stakes, I agree with Matt. So is HITRUST, so is ISO 27001. These are areas you have to move into. You have to show that your security is up to date. You have to work with your IT partners. You have to know exactly what they're looking for. And every one of the partners that we work with is uniquely different, right? So when you're setting up integration, whether you're an Epic customer, or CERN, or Athena, you have something else, NextGen, all of these different groups require different levels of integration, whether you're working through API, HL7, bi-directional, what you're doing. And many of the things that were mentioned before were the way that Pacemate started their company back, or the way that we started back in 2015. So for many years, we focused directly on integration, integration in and integration out. And you wanted to make sure that you were sharing bi-directional information, pulling medication data and demographics into the system to make the system more useful for the EPs and those clinicians that are interacting with the data. So we talk about optimal device clinic, and it's great to talk about AI, and it's great to talk about all these things where we all are going, by the way, and we're all working with that. But you have to solve today's problems today as well. And I think that's one of the largest things we haven't talked about in this room right now is connectivity, compliance, and making sure that you're connecting with the patient. And there's a lot to talk about the data, but I do want to recommend that this room and this panel keeps the patient at the center of what we're doing in every part of the discussion. Because at the first HRX, we got to really have a spirited discussion on who owns the data. And I still don't think that that's really been solved, to be quite honest. And the data exchange is gonna be great to move us forward in medicine, but we really need to come back to who's the center of that, and that's the patient and how we interact with them, making sure that they're compliant and connected. And I think you bring up a good point, Brian. I think, you know, also is implementation. You can have the best technology, but if there's not trained, I know training came up, and having the staff, the trained staff, to implement that technology, it's just gonna sit and kind of die on the vine. So I think there's multiple things that need to be happening, and there is a shortage. I think probably pandemic and post-pandemic, healthcare trained staff shortages, and I think addressing that with education will be useful so that you can implement the technology, enhance those folks. I think right now, software's enhancing the trained staff you have. It's not replacing that staff. You still need trained eyes to take care of that patient. And there was a great invitation to come by the 91 booth, and I encourage everybody to do that. I encourage you to go to every booth. I encourage you to come to our booth, come to Matt's booth, and stop by and see, and the ones that we all compete with. We're all pushing each other. That's what's great about what's going on in EP right now in this selective area, is that the tide is rising, and we're making better healthcare decisions for the patients. I think those are great points, because one of the considerations for our team when we considered remote monitoring, the physicians, the nurses, the EP device specialist staff, myself, was which company will work with us as a partner? Who will come in and help us with customizing our workflows that we already have in place, but how do we customize it so they are actually part of our team? And so communication was also important, ensuring that in those initial stages, when trying to vet for who is the right type of remote monitoring solution company, is who's talking to us? Who's having those conversations? Who's helping us along that process? And that's what ultimately helped us decide which worked best for us. And I think if you do that- Which brings me to my question, if I may ask, because I'm Aileen Farrick. I'm one of the co-chairs of the writing committee for the 2023 document, and I love that we're having these discussions, because we're really having the discussion about implementing the guidelines in a practical way. So one of the things that is in the guidelines about outsourcing is how you can use it for part-times. We've talked about coverage for seven days a week versus 24 hours a day. I'm sorry, I should say eight hours a day, Monday through Friday, versus 24 hours, seven days a week, and other things that outsourcing can accomplish for the clinic. But in my dealings with a lot of clinic directors, like Rennie here, how do they know which service they should use? How do they put together a plan that they can bring to administration to say that it's not gonna cost them more, that perhaps their revenue will be greater? We talk about patient-centered care, the fact that we're not losing patients, maybe not seeing all alerts, because we're not operating fully. So I guess my question is, if I'm the director of a device clinic, how do I start to approach an outsourcing program to see what my needs are, and how can I put a plan together that I can bring to administration to actually implement it? Sure, yeah, I think, as Brian mentioned, I think it starts with, HRS has a HRS forum. I think there's a lot of good references there. I do think doing your homework, going to all the booths here at HRS is a good place to start. Every clinic needs are different, so I think we'll kind of, but they are changing. So you mentioned, and I'm curious, Jesse's take here, on average, I think the average health system has 1,300 vendors. I know recently there's been a push to kind of limit the number of vendors, and there's significant cost savings to do that. So I do think it is kind of a more value, taking a value-based procurement process, as you vet your vendors, to identify what are my immediate needs, and then what am I looking to do long-term? I think, Dr. Catanzaro, when we started working with you all, I think the immediate need was staff to kind of get things organized, streamline workflows, but ultimately, phase two is, and I want to applaud you for your work with the North Carolina Telehealth, collaborating with you to do that, I think, to kind of address health equity in your communities. I think that's made possible through strong partnerships here, so both short- and long-term goals of improving care by selecting the right partner. So vetting, proper vetting, references, we provide references of all of our customers, I think is doing your homework, and I think there are more resources now than there were. You mentioned HRX. I think that's another great meeting where there's a lot of good discussion like this happening. I very much agree with what Matt's saying. I think it starts with open and honest conversation about the challenges that you're having in your health system, and then the goals that you're setting out to go for operationally. Without going too deeply, we work with Piedmont. We have been a partner of Piedmont for quite a long time, and I got to know Jesse very well through that process. What Piedmont was trying to do is very different than what some of the smaller regional clinics that Matt, you and I both service, and so understanding what those challenges are will lead towards a plan of what you need to set out on it. At Pacemate, we offer software to clinics that want to take care of everything themselves. We offer clinical services for staff augmentation if that's needed, and then we offer a complete communication staff that just focuses solely on compliance and making sure the patients are educated and filling in. It's been a very recent movement in the market that we're seeing where more clinics are taking the software and the communications approach and filling in their own clinical services, but getting that help for all of that halo effect that's needed around the patient to make sure that they're compliant, educated, staying connected, those types of things. Everyone's different, but it's open and honest conversation in the beginning, so you can sit down and really develop what those goals are and work together towards a shared solution. Well, we really do want to open up this session to other audience questions, so please put it through the QR code or come up to the mic, but just to expand on that last question, do you guys bring in a team to shadow for a day, a week, the clinic, so that you can observe what their current practices are, where you think that you may be able to collaborate to improve efficiency? We do, right? So it all starts with understanding the clinical challenges and financial challenges that you might be dealing with. The ROIs, you talked about Dr. Canzaro, is very important to the clinic to understand what they are looking for financially and what the goals are. Then we come in and we service map everything. So Pacemate, again, works with you from the CRM perspective, the ambulatory perspective, heart failure perspective, cardio MEMS. All of these devices flow through the system, now moving into more advanced heart failure with the new devices that are coming to market. No longer are we just talking about one system that you're wanting to bring in for interoperability. Your heart failure physicians want to talk to your EPs. The EPs want to talk to the ICs and structural. You wanna have a complete database of everything. So Pacemate comes in and maps all of those different workflows and how all that information moves and how all that communication needs to happen. Yeah, similarly, we're there. I think it's typically just the way they're doing is not necessarily where they want to be. So we meet people where they are and then kind of take them where they need or where they'd like to be. And I think that, especially when it comes down to building integrations, you likely don't want to build integrations. Sometimes your current workflow, you want to map that to where you want to go. So yeah, we embed folks that would go there, visit on site. And also, in some cases, physical bodies there if they're utilizing our in-clinic staff. So I do think, as Brian mentioned, that's important. That's initial scoping. It takes time and the integrations can always take longer than liked in some cases. But the end goal will be, the patients will be better cared for and the staff will be working much more efficiently if that time is taken up front. And my perspective and philosophy, as you'd expect, is a little different. We don't consider ourselves a vendor. If you're looking for a vendor, you should not even come by our booth. We're a partner in your management of your clinic and that's why it doesn't matter whether you're looking for just patient engagement or a software platform or working on research with us. I think the first, and it's a very good question, if I were to run a hospital or clinic, the first question I'd ask is why you're doing what you're doing. Are you a business? Are you the founders? Who's funding you? Are you P-owned? What does that mean? Where were you two days ago? Where are you today? Ultimately, I think it starts with why and then I would ask for a very rigorous evaluation. I think we went through one of the large health systems. They had something like 17 pages of questions and then they ask every question and they put it to a vote across all the physicians and then they decide unanimously or by majority. And part of the process is, of course, reference checking. I mentioned Yale before. We've had clients go to Yale and shadow their clinic for a full day. Now, I'm not offering that because, as you know, it can be very overwhelming, but I believe in 100% customer satisfaction and that means we will absolutely do everything that's possible in conjunction with the customer. That means we do not say this is not possible because we don't have it in our system. We'll give you a clear answer as far as technology goes. And on the service side, we have a program of education that goes through, as I said, we're looking thoroughly at every inch of the PDF, which ones need to be observed or seen, which ones need to be handled immediately, for example, go straight to the physicians, which go into archive, which go into maybe comes back later, which show up in the summary and so on and so forth. But I think the conversation around remote monitoring as a patient-centric and a great beachhead for changing healthcare into personalized patient care has to happen in the context of a partnership, not into a vendor-hospital relationship. And I really believe in this, and this is why I said, we have actually told many clients who are not interested in working with this too early for us. Well, I'd like to thank everyone at a respective time for today. I think the way we do this is learning from each other and don't just look for a solution. Understand your problem. Understand, I think, where you're missing. Is it on the personnel? Is it the remote portion? And understand that you need buy-in and stakeholders. And that's what this group of people is here to impart and for you to leverage. And I think it's only gonna get more and more interesting, but with the patient at the center, I think we can only go further by sharing information amongst ourselves. So thank you again for your attention and enjoy the rest of the conference.

Heart Rhythm 2025

device clinic design

remote monitoring

alert management systems

industry collaboration

staff education

AI-driven solutions

data integration

patient-centered care