Really great oral presentation session that we have set up here. We've got some great presenters, great topics. I'm looking forward to learning a lot from our colleagues here. We're going to try to stick to the time frame, so I'm going to not yap too much here. There will be time for questions at the end of each presentation, but if we go over, our presenters have offered to hang around on the sides a little bit afterwards, so please feel free to address them with your questions. It's our pleasure to welcome you here to San Diego and the Heart Rhythm 2025. This is the 46th meeting of the Heart Rhythm Society, and it's an absolute pleasure to have everyone here and meet everybody at this beautiful space. 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 other sessions, not this session. For Q&A here, we're going to be using our voices, old school. Please note that visual reproduction of Heart Rhythm 2025, either by video or still photography, is strictly prohibited. All right, and with that, let's just jump right in. It is my pleasure to introduce to you today Dr. Helena Lopez Martinez. She is here today as our award-winning Women in EP Best Oral Presentation Abstract, and she brings to us today an important topic about ethanol ablation and some of the challenges that come along with the regulatory aspects of it, and we can all have a nice discussion about what kind of controllable factors we can put in place to prevent this from being a big problem. All right, Dr. Lopez Martinez, please. Thank you so much for the introduction, and thank you everyone for being here with us. Today, let me start with a bit of history. For years, hundreds of drugs have been marketed in the United States without having received formal FDA approval. Many of these products entered the market decades ago, and due to the complexity and changing landscape of early legislation, they remain available without undergoing rigorous evaluation for safety and efficacy. With the purpose of addressing this regulatory gap, the FDA launched the Unapproved Drugs Initiative, or UDI, in 2006. The UDI was a program aimed at encouraging manufacturers to comply with the FDA approval provisions by offering a powerful incentive, market exclusivity for those manufacturers who secured first-time approval, along with enforcement authority to eliminate unapproved competitors. Even when the primary purpose of the UDI was to protect patients' health, it had detrimental consequences more often than anticipated. That was the case with dehydrated alcohol or ethanol. Injectable ethanol was first introduced in 1946 to increase caloric intake. Over time, its composition evolved to increase ethanol concentration, and its indications broadened to include neurolysis, tumor and arteriovenous malformation and volatilization, myocardial septal ablation in hypertrophic cardiomyopathy, and most recently, ablation of cardiac arrhythmias. In the field that concerns us, ethanol ablation is not routinely performed in all centers due to high technical complexity. However, it is increasingly being used in the last years, and we already have robust evidence demonstrating its clinical value for ablation of persistent atrial fibrillation. Several unapproved ethanol products were available in the U.S. for an average of $25 per milliliter until 2018. At that time, ablisinol entered the market as the first FDA-approved ethanol product at an overly higher price. With both an average wholesale price and wholesale acquisition cost of almost $200, this implied an increase of more than 500% in ethanol cost. As a result of the UDI enforcement action, all other ethanol products were removed from the market. And because ablisinol had previously gained an orphan drug designation for the treatment of hypertrophic cardiomyopathy, the granted market exclusivity was set in seven years. Even when this exclusivity was linked to that specific indication, with ablisinol resulting shielded from any market competition, its price has impacted all its indications until the present time. The truth is, no evidence was submitted during the approval process to demonstrate that ablisinol offered any meaningful advantage over the alternatives, let alone to justify such a substantial price increase. For that reason, we aim to assess ablisinol's cost, efficacy, and safety in its use for cardiac arrhythmia as ablation compared to equivalent products currently available in other countries. We collected information from nine centers across America, Europe, and Asia and complemented it with our own experience using a previously ethanol product in the U.S. We then compared these findings with our outcomes with ablisinol. Efficacy, or ablation success, was defined as the appearance of a new low-voltage area or loss of local electrograms. Safety was assessed based on adverse events likely attributable to ethanol itself. And to ensure compatibility, all prices were adjusted for inflation to generate 2019 dollars, which corresponded to ablisinol's effective pricing date. We found that ablisinol's price was dramatically higher than comparable products both internationally and in the U.S. prior to its approval. The median price of equivalent products was only slightly over 30 cents per milliliter, even when their ethanol concentration was similar, or in many cases, exactly the same, as you can see next to each manufacturer's name. In our aim to investigate if such a price difference was justified by superior performance, we gathered information on almost 3,200 ethanol ablations. Four hundred of them were performed with ablisinol and 2,800 with other products. Most frequently, these were atrial fibrillation ablations, and in a minority of cases, premature ventricular complexes or ventricular tachycardia ablations. Across the board, the vast majority of ablations were successful with a very low incidence of ethanol-induced adverse events. But most importantly, no significant differences were found between ablisinol and its more affordable counterparts. The data shows that ablisinol's exclusivity and price increase are not justified by clinical superiority. Instead, it is an example of how regulatory incentives can be leveraged for financial profit, leading to reduced access to prescription drugs and without adding substantial value for the patients. We believe it appropriate to point out that the case of ethanol has not been unique. A key study led by researchers from Yale University and the University of Utah analyzed the impact of the UDI on 34 drugs between 2006 and 2015. They found that the price of the targeted drugs increased by a median of 37%, with some of these drugs being as commonly used as the EpiPen, morphine, potassium supplements, colchicine, which experienced an increase of more than 1,000%, or vasopressin, surpassing 6,000%. Additionally, drug shortages became more frequent and prolonged, and remarkably, 90% of these FDA approvals were based on literature reviews or bioequivalence studies instead of new clinical evidence on efficacy or safety. These findings were central to the decision of discontinuing the UDI in 2020, but as we have just seen, some of its consequences still impact the current market. Similar situations occurred with parallel legislations, as it was illustrated by the mexilatin case in Europe. Mexilatin had been in the market since the 1970s. In 2014, it gained an orphan drug designation for the treatment of non-dystrophic myotonia, which in 2018 triggered a 10-year exclusivity period under the European Medicines Agency rules. Consequently, mexilatin price skyrocketed, again impacting not only its orphan indication, but also its long-established cardiological use. The case of ethanol is just an example of a pattern that keeps repeating itself. We believe it is important that we remember these lessons moving forward to avoid these situations continuing to happen. We owe it to our patients to demand that future regulatory efforts strike the right balance, encouraging innovation and compliance, yes, but never at the cost of drug affordability. Thank you so much, and I will take any questions you may ask. Thank you so much, that was a really inspired talk. We're about right on time. I guess I'd just like to end with one question to you. If you had the magic wand to fix it, what are some simple things you might implement to make that change? So, I believe we have already seen how these situations tend to repeat itself, and we know there's a potentiality of this to happen again in the future. So, I think we should be able to implement some post-marketing regulatory strategies which would allow the FDA to detect these companies abusing of the benefits that they granted, and maybe if a company is abusing of this power, maybe they could have the power of implementing some sanctions or even withdraw any exclusivities that they have given, for example. Thank you. Thank you so much. Thank you so much, and I will take any questions you may have at this point. Thank you again. Okay, let's sit back here. So, next up, coming to us from across the pond, as they say, is Dr. Mark Gallagher, Professor Mark Gallagher from St. George's University Hospital in London. We're eager today to hear his topic involving a comparison that I think is very topical for this meeting here, and it's looking at a cost comparison between pulse field ablation and doing RF ablations with esophageal thermal controls. So, Dr. Gallagher, please. Thank you very much, Chairman. Ladies and gentlemen, this is a, it's almost an embarrassingly simple presentation here. Most of what we do is quite technical and complicated. This is a very simple cost comparison, nothing sophisticated about the economics of it. Cost is very important in ablating atrial fibrillation because of volume. Now, it constitutes perhaps 70% of the ablation we do now. It should probably be 90% just based on raw epidemiology. It is cost effective, but it is expensive. Now, to keep the procedure safe from the point of view of esophageal complications, we have two alternatives. We know that pulsed field is safe from that point of view, but we also know that we can protect the esophagus by cooling it during radiofrequency ablation. So, these are the options. We've certainly seen an overwhelming uptake of pulsed field partly because of that concern about the esophagus. But pulsed field, we know, is expensive. We decided to quantify that. The expense of pulsed field is often justified by the increased efficiency, saying that it, that the cost is counterbalanced by the improved throughput. We quantified that. So, we looked at 77 consecutive patients treated with FaraPulse, 50 with PulseSelect, and 87 who had radiofrequency ablations with protection by an ENZO ETM. Now, these were not randomized. The allocation was purely based on availability at the time the patient was treated. So, the, they're not contemporaneous. Most of the radiofrequency and ENZO ETM patients were treated around about 2020 to 22. The FaraPulse and PulseSelect patients have been more recent. We only took up the PulseSelect in the autumn of 25, so, sorry, 24. So, these are all quite recent. The patients are therefore not matched. They're, they're moderately similar. The recent one's more persistent, and evidently, the people using the FaraPulse were not really using it for the redo cases and atrial tachs, whereas for the PulseSelect, we've been using it across the board. The general workflow in our center is that we use general anesthesia for all AF ablations. We use transesophageal echo to guide the transeptal. That, ironically, is for cost reasons. In the UK, a, an intravascular echo probe is prohibitively expensive, so we use them in perhaps one case in two or three hundred. Transseptal was almost always with a BRK1 needle through an SL0 sheath with a small amount of use of a safe sept. We mapped with a catheter, depending on the mapping system used, when a mapping system was used, which was not universal, and ablated with an STSF or a QDOT in the case of the RF cases. Electroanatomical mapping was performed in all of the RF cases, around half of the FaraPulse cases, and a smaller majority of the PulseSelect. And the, the main data are here. So, the pulsed field is considerably more efficient. We got through the cases in 80 minutes for a, a PulseSelect, a little under a hundred for the FaraPulse. Getting close to three hours for the radiofrequency. The fluorotime was significantly higher for the PFA cases. But the costs worked out like this. So, the radiofrequency, moderately expensive. I think it would be cheap by US standards, but coming to a little over £6,000. So, that would be $8,400 and some dollars, and that includes really everything. We, we lumped everything in there, including the staff costs. The staff costs calculated by the exact number of people in the room, and the wages of those people, and the duration of the procedure. And the equipment costs calculated down to everything, including the short sheath for the coronary sinus catheter. The FaraPulse ended up here for expense, £11,000, and the PulseSelect somewhere in between. The, the lesion sets were different. They're not entirely matched. The people using the FaraPulse tended not to do mitrals and CTIs, and if they did them, they didn't use that device. The PulseSelect cases used lesion sets pretty much the same as we had been using with RF. Now, when you looked at just the patients who had the non-PV lesion sets, the cost difference was even greater. Because people using FaraPulse were using other ablation catheters, for the CTI particularly, that inflated the cost even more. And because in those cases they were using a mapping system in every case, you had the cost of the mapping system and mapping catheter. So you have pretty much a doubling in cost in the case of an extensive ablation done with radiofrequency compared to one done with FaraPulse, with again the PulseSelect in between. Because for the PulseSelect, we're using the same catheter for the CTI, the mitral, the roof, the posterior wall, the whole lot. And to conclude, the pulsed field is more expensive. And that differential in expense is not compensated by the shorter procedure time. It is an almost doubling in cost that includes the saving on procedure time and wages. There's a small difference in radiation exposure, but I wouldn't consider that very important. The patients are in their late 60s and the absolute amount is very small across the board. And we have to acknowledge that PFA improves scheduling flexibility because the procedures are a little more predictable. And at present, we deal with two-year waiting times for these procedures. So getting through four cases a day in the lab instead of three is important, but vastly expensive. So thank you. Thank you. We have some questions. Dr. Sickle? Oh. Sorry. Question regarding the total cost of all procedures if we did pulse field for everyone. Because you're talking about more procedures, but also more costly procedures as well. So if you're doing those five a day instead of the two or three a day with your lab capacity, I can see it bankrupting many public systems throughout the world. So what do you think? Bankrupting the government is tough. We're working hard at it, but we won't bankrupt it. It's a matter of distribution of resources across needs. Now, I've got to look after the patients who come to me. And looking after the numbers we have with the resources we have at the moment pushes us toward using pulsed field. I think if the system pushes back, they will want us to either ration or rationalize. And rationalizing would mean moving back to RF and protecting the esophagus with an ENZUETM or whatever other method someone comes up with. And if they were to do that, they would have to provide us more labs. And that's the limit. You know, we have quite a number of operators. I could easily do ablations five or six days a week instead of two and do less outpatient time and ward rounds. I would love that. But that's not for me to decide. So these are the solutions we can offer people. Thank you for that excellent presentation. We've done a small study where we compared the same-day discharge rates versus 30-day and 30-day readmission rates between PF and RF, knowing very well that the costs of PFA and the catheters are way higher than RF and the utilization of general anesthesia is also higher in PFA. We found that the 30-day readmissions were way lesser in PFA and the same-day discharges were higher. So do you think that's going to have an impact on the overall health costs on the community and the burden per se? For us, the same-day discharge was the same and the use of general anesthesia is 100% across the board. So those were not relevant. I think most of these people we could have sent home same day, again, across the board. I think the rate of readmission was small. We haven't looked at that, but we certainly can. We can go back and interrogate this data set for the number of readmissions and try and cost those out, but those are rare. You do get a few with the RFs on account of fluid load. Yeah, we can have a look at that. But readmissions, I think we run at about 2% or 3%. So it would not come anywhere near the cost differential we're describing here. Well, thank you all and thank you for the audience engagement. If there's any other questions for Dr. Gallagher, he'll be around. You can ask him after the presentations. Next up. Let me make sure things are loading here. Okay, so next up from the University of Kansas, we have Jessica West. She is here to present for us today a very pertinent topic for any of us who have worked in device clinics on how to engage patients to keep with their compliance by way of automated text messaging. I'm not sure how close I need... okay I think I can hear myself now. Hi everybody, my name is Jessica Parker. Hi everybody, my name is Jessica Parker. I am the ambulatory electrophysiology supervisor overseeing the cardiac device clinic at the University of Kansas Health System. And I am honored to be here today to look at our journey, our insights, and our outcomes with automated text message reminders for patients with manual transmission cardiac implantable electronic devices. And I'm going to let Megan step in here with me. Hello everyone, my name is Megan McCabe and I'm the manager of data at Clinical Data and Analytics at Merge and I'm thrilled to be here with Jessica to co-present this study. I have no disclosures and Megan is a salaried employee of Merge. The University of Kansas Health System is a tertiary medical center recognized for comprehensive cardiac... recognized as a comprehensive cardiac center. So we monitor roughly 6,800 patients currently on remote with about 600 of those being non-wireless patients. A non-wireless patient or a non-wireless device means that the patient has to manually send in a transmission to us for us to be able to review data such as alerts or if there's any issues going on with the device. We utilize Merge patient management software to provide comprehensive care to our patients. The CMS guidelines recommend that we review a remote transmission every 91 days or four times a year. Since the patients have to manually send these in for non-wireless devices, a lot of times the patients forget which in turn delays patient care and also... also makes it hard to meet the CMS guidelines for reimbursement. We did present a study here last year with my manager Katie Jasky. We looked at utilization of staff resources for managing these non-wireless patients. So if you're looking, we use remote monitoring interval as the 91 day that we're trying to meet. So we have the recommended interval, which is the 91 targeted day, 91 day targeted, which is four times a year. Then we have the completed interval, which the actual... the completed interval is the actual interval that we're getting these transmissions in. So as you can see on the top timeline here, we have a transmission somewhere in that 90 day period four times that year. So that's 100% compliance, which is what we're looking for in a non-wireless device. On the bottom timeline, you can see that we have a 75% compliance. And that's because we have two out of the three... we have three out of the four. We've met those three out of the four, sorry. We've met those three out of the four, sorry. And we had one in the first 91 day interval, the second one. And then that third part of the timeline down there, we have 181 days there that we're looking at. And the problem there, and what we don't want to see, is if we don't get a transmission, we cannot really provide the care that we want. We're not giving the standard of care that we would like to give. So we are trying to meet that compliance. So the objective of this study was to test if we could increase compliance to the recommended four remote monitoring intervals a year, and could we increase reimbursement while doing this. And I'm going to pass over to Megan. So we introduced automated text message reminders at the University of Kansas in June of 2023. And since then, 92% of the 372 patients that were invited to the program opted in and were immediately enrolled. All of these patients had a CRTP or a pacemaker device and thus had 91 day intervals or four intervals per year. And as of October 2024, 105 of these patients had 365 days of remote monitoring before the introduction of the program and after the introduction of the program for us to analyze. The interval in which they opted in was considered a buffer interval in which no results were calculated. And we looked at the 365 days before that interval as a baseline and compared it to the 365 days after. And as Jessica spoke to, we were looking at the number of remote intervals that were completed within that time frame, as well as the comparison of completed to potential or percent compliance. We used the publicly available rate in Kansas of $52 per interval to estimate the impacts to reimbursement. Overall, we found that the program was highly successful. Patients were twice as likely to meet the standard of care with the introduction of these automated reminders. That was 30% of patients meeting the standard of care before reminders and almost 70% after reminders. On average, that correlates with an average of half an interval per patient year. And you can consider these results in terms of how many remote monitoring intervals were completed for a year, or again on a percentage basis as we've shown here. We were also curious to look at these results for patients that had room to improve. So 73 out of the 105 patients looked at here were not meeting the standard of care prior to the introduction of text reminders. And after we introduced these reminders, almost 60% of this group were meeting the standard of care, so they were transmitting on time. This correlates with 0.8 additional intervals per year on average per patient year. Next, we estimated the impact to reimbursement, and we found that overall on average across the 105 patients, there was almost $29 additional per patient year or an 18% increase. And for the patients with a history of noncompliance, that was even more accentuated, so a $43 on average additional or 30% increase. Finally, we looked at whether or not age correlated with improvement, and we're happy to find that age did not correlate with improvement, so which is a very exciting finding for the potential of generalizing this across a broader group of patients. Thanks, Megan. So the end result of this study was that we were able to see that there was an increase in the number of patients with a history of noncompliance. Next slide, Megan. So the impact of automated text messaging. So the overall impact we observed was a marked improvement for staff utilization by eliminating the need for physical letters and reducing the time spent on MyChart entries. Transitioning to an automated text messaging system allowed us to efficiently follow up with our outlier patients resulting in increased compliance, improved reimbursement, and better follow-up patient care From our clinic standpoint, number one, it was really nice to see that age did not correlate. I hear a lot in our practice, are our patients able to take on the new technology that we're offering and that patients don't want to download apps or they don't want to get text messages, and it was really nice to see that our compliance looked really great and it didn't matter about the age. People are ready for the new technology. They're ready to take it on. And it really was nice to see, from a clinic management perspective, my team really was happy to see that we could triage these alerts effectively. Waiting 180 days to see that there was VT that happened 100 days ago, that's hard to report out to a physician to say, hey, there was 30 seconds of VT, but that happened four months ago. So it was really nice to be able to increase our compliance and provide better patient care overall. I do just want to say thank you to all of the co-authors and the people who helped me and the team work on this study with Merge. And thank you so much for having us. Are there any questions? I love this. It's a simple solution to a problem that all of our clinics have faced. Are you doing anything with different languages? I think that's a good call-out. We don't have a Spanish version right now, but most of our remote monitoring resources do have a Spanish version. And we probably should explore some other languages that we could translate these things into. It'd be interesting to see that, Megan, I think, and for our clinic. I work in Canada, and we're lucky if we follow up patients once a year. Lots of patients getting missed, and the VTs are at least a year old. Is this overkill? Every 90 days seems a bit much. The 91-day interval is set by CMS guidelines, so we try to meet that. I don't know if it's overkill. I think waiting a year to see VT is maybe not ideal, just depending. I'm not a physician, so I don't know that I can speak to it. But I think from a nursing and patient care, and what are we offering, and we put in these devices, and I think that the follow-up on the devices is important, and addressing what we see on those devices is important. They come to us and put their trust in us. I think if it was my mom or dad, that's the kind of care that I would want to give to them, and I'd want them to get from other people. Thank you. Very good. Thank you so much. All right. Next up, from Canada, we have Dr. Marcus Sickle. And this is another topic that's near and dear to the hearts of those who have worked in device clinics, that data deluge from loop recorder monitors. So let's hear what him and his group have come up with in terms of how to optimize those. There you go. So, yeah, Marcus Sickle, originally from England, as you can probably hear, but work in Victoria, BC, Canada, head of EP at my hospital. So nothing to disclose, which is relevant, because I'm comparing two devices here. So this is Reveal Link versus Confirm RX. So to give you some background, ILRs provide long-term monitoring for patients, but reviewing transmissions is pretty intensive, resource intensive. The devices are expensive, certainly in our system. And what happened in around 2020, 2021, is St. Jude came in about $1,000 cheaper on their loop recorder. So it cost us $1,000 Canadian less to buy a loop recorder from the Confirm than the Reveal Link. But our clinical experience was maybe that the Confirm was giving higher false positive rates. And so we set out to look at this. We wanted to look at true positive rates, false positive rates, and ultimately look at the cost, not just of the initial purchase, but of the follow-up that was being provided in the clinic. So this was a retrospective chart review, looking at the period before and after this change in provincial rule. There were 53 patients implanted with a Confirm RX device, and 42 with Reveal Link from two health authorities. And the follow-up period was 842 days for the Link devices on average, and 465. All the data you're going to see is corrected for time, of course. So in terms of the implant, very similar implant procedure. It was the same intercostal space, and the R-wave amplitude was pretty good for both devices. 0.59 for the Link and 0.57 for the Confirm. In terms of device programming, it was pretty similar. Pause duration was three seconds for each. AF detections were actually a bit shorter, set a bit shorter for Link than for Confirm. 6.9 minutes for Link and 9.4 for the Confirm RX. So you would expect maybe more false positives for AF in the Link with that threshold. And tachy-detects were pretty similar. These were the patients, similar patient mix. I won't go through all this, but fairly similar indications for the implants. And this is what we found. So to take you through the graph on the left here, we have Link in blue and Confirm RX patients in black on the right. And we have total number of transmissions per year on the y-axis. And you can see that for Confirm RX, there are many more transmissions. And that meets statistical significance. Each of those dots is a patient. So you can see the individual patient data. And these are transmissions rather than individual episodes. So within each transmission, there are many episodes to look through. Or potentially more than one episode to look through. In terms of the true positive rates, this was pretty similar for the two devices, as you can see from the graph on the right. And this was the false positive rates. So with Link on the left there, you can see that there's an order of magnitude less false positives for Link than for Confirm RX, which gave at least tenfold greater false positives. Some of the patients up to 250 episodes per year. And then in the right, you can see the breakdown. So different types of false positive transmissions for the Link versus the Confirm. So for atrial fibrillation on the top, you can see that there's a real difference. Confirm RX having many more pauses as well. Confirm RX having many more false positive episodes. And tachy was no different between the two. So those were the types of alerts. And this was, we did a deeper dive. These were obviously adjudicated by multiple individuals, at least two electrophysiologists. But we were looking at the causes of the false positive atrial fibrillation episodes. And we were finding that this is the breakdown. You can see for the Link, there were a few in the PACs and a few in the PVCs causing the false positive AFs. Whereas for Confirm, obviously many fold greater. PACs was the commonest cause of a false positive AF. PVCs, you can see an example here on the top right in terms of the readouts that we're getting from the device, the electrograms. That was a false positive Confirm RX PVC episode. T-wave over-sensing, that's the example in the bottom right here. And you can see the annotations where it thinks it's AF, but it's actually just a big T-wave. And Wenker back was one of the other causes for false positive AFs. So this wasn't randomized, of course, so we had to look and see if there were any other factors that might be contributing. We plugged everything into a multivariate analysis, including everything that we could think of that would perhaps contribute to false positive alerts, including age, sex, BMI, etc. None of those factors were significant. And in fact, the device with this ridiculously low P-value was the only thing that led to more false positives. So how does that relate to cost? Are all these false positive alerts more expensive? Did the devices save us money because of the initial purchase price or were they costing us money? Well, obviously, technologists spend more time reviewing false positive alerts for the Confirm RX than for Link. The review costs were greater for both the technical staff and for physicians. And the physicians are paid for by the province and ultimately that's paid for by the taxpayer. We ran Monte Carlo simulations of the costs. So this is based on the cost of the initial purchase. You can see that on the left. We have 95% confidence intervals there. So you can see the Link graph in blue. So the blue line is Link costs. Starting out a little bit higher, but ultimately staying pretty flat throughout and quite predictable costs for the Link in terms of the technician review time. Whereas you put in a Confirm RX and you might be spending $30,000, at least at the top 5%, over the three or four-year timeline. This was the average of the 10,000 Monte Carlo simulations. And so you can see that the mean Link cost including the initial purchase price comes out significantly lower than the mean Confirm RX cost. So in summary, certainly we saved some money on the implants, but in terms of follow-up, these devices were much more costly to follow up. It was a higher and highly variable false positive rate amongst the Confirm RX devices. And so over the lifetime of the device, this proved significantly more expensive. And overall, I think this gives a cautionary tale in terms of jumping in both feet when a cheaper device or even ablation technology becomes available. And perhaps a pilot period of use would be beneficial. And so next time the province comes along and tells us to use a different device, we may show them these slides. Anyway, thanks. Thank you. Thank you so much. It definitely highlights for us that where you might be saving in the beginning, you're going to end up paying for even more so in the long term. Is there any option that you might think could work to like model mix where like a certain type of indication for monitoring gets the lower cost monitor? Maybe something like AFib management that won't trigger as many alerts ideally and then maybe save the higher price implant for more sensitive indications? I don't think so. The problem was it was quite unpredictable who was going to be getting all these false positive alerts. And you're probably never going to turn off the pause alert, right? I don't think you would ever say, oh, I'm going to set that to 20 seconds because then you're going to miss potentially significant events. I mean, for me, this was just an example of an inferior technology that we were using and probably shouldn't have been. So I think that the illustration of inferior technology and how this shows it is important. But I also think no one's putting in Confirmer X here anymore because they now have the Assert. And I think the false positive rate is down dramatically. And with AI, it will continue to improve. And the cost of the device may come up a little bit with that. But if that's not the case, then the concept of watch your technology, if it's cheaper, it may not be better. I understand that. But if we're looking at Confirm's product or Abbott's product versus Medtronic, a little bit of now apples to oranges. And what's your thought on that? Thank you. It's an important point. I think every time there's a new iteration of the device, it should probably be tested in a randomized fashion or at least in a pilot manner before jumping into it. And I think we've gone away from that. It's far too easy to get a technology through on the basis of, oh, it's similar to the old technology. Well, how similar and how well does it actually perform in a pilot phase? So that's what I would want to know. Thank you. Thank you so much, Dr. Sickle. All right. Well, thank you for everyone for sticking around. You've made it to our headliner here. We are here to hear the final presentation, which has won highest quality improvement, highest scoring quality improvement, oral abstract. And here to present our presenter is Dr. Thomas Dearing from Piedmont Heart Institute. Thank you very much, Jamie. It's an honor to be here to do this. As you know, the Heart Rhythm Society receives a large number of abstracts on an annual basis. Most of them are very good, but we can't accommodate all of them in our sessions. They're submitted to various categories and they are graded by abstract reviewers. Those are then reviewed by the program committee and there are grades assigned. And above a certain cut, abstracts will be accepted for presentations here in the standard rooms and as posters. To make a long story short, it is our tradition every single year within the various categories to award the individual who has the highest scoring abstract overall. So it is my distinct honor this year to be able to honor my friend and colleague, Dr. Jared Bunch, for the highest abstract score in the quality improvement section. All of you have done a wonderful job and I really think that we deserve an extra round of applause here for Dr. Bunch. Why don't we go over to the side? They're going to take a picture. All right, with that introduction, it'll be hard to meet expectation, but I appreciate the Heart Rhythm Society, a good friend, and Tom, and all of you. And I represent a team of very skilled people, and they own most of the credit for this work. And I want to share with you the patient care pathways and outcomes following newly diagnosed atrial fibrillation. This was a joint effort led by the Heart Rhythm Society and our colleagues at Johnson & Johnson, Biosense Webster. The study was funded by them, and we relied heavily on their expertise, and they have unique statistical expertise that really taught me a lot through the process. So as a background, the prevalence of atrial fibrillation continues to grow amongst Americans. It's approaching 5%, but what I think is very interesting in this contemporary analysis is the fact that it's born in elderly patients, and we see as aging increases, it's born in particularly in elderly women. And as management strategies for atrial fibrillation have expanded, there's increasing opportunity for clinical and technical expertise. And the variability in referral patterns and treatment may impact atrial patient outcomes. So what we wanted to do with this study was threefold. We wanted to find the current landscape of AFib referral pathways in the U.S. We wanted to explore treatment patterns on these various referral pathways and focus on guideline-concordant care and anticoagulation. And then we wanted to define outcomes associated with these referral patterns and treatment patterns. Data were obtained from the OptumDiaidentified Cliniformatics database from 2015 to 2023. Atrial fibrillation was defined by ICD-10 codes, and patients were selected if they had the following criteria. They had a diagnosis of atrial fibrillation or flutter, they had an AFib-related ablation or excluded, excuse me, so prior diagnosis of atrial fibrillation, a prior history of treatment suggestive of atrial fibrillation, like catheter ablation, anticoagulation for arrhythmia, or if they had no visit after the initial diagnosis for 12 months, or absence of clinical specialty information, and that gets important when we understand taxonomy of care, and I'll go over that. The specialty of each clinician involved in the AF Care Pathway in 12 months was followed. Clinical specialty is coded in this database with a taxonomy code, so we're able to look at it specifically. The type of clinician, each node in the pathway was recorded based on training, physicians versus APPs, and if there was more than one taxonomy code, we followed the following priority order, EP, cardiology, PCP, APP. Care outcomes included new prescriptions for antiarrhythmic drugs, oral anticoagulation, and then specifically healthcare utilization, AF-related hospitalization, AF-related emergency room visits, heart failure hospitalization, and stroke. These are the statistical methods. We described the cohorts descriptively. We performed T-test and Chi-square test to compare. We also summarized demographics, both based upon Eltsch-Hassler index, CHAS-2-VASc score, AF type, and other clinical conditions, and then we performed proportional hazard regression models in order to look at the association with new treatment of antiarrhythmic drugs, oral anticoagulation, and the healthcare outcomes as previously described. Let's jump into the data, which I think is critical. So we take this database. There was 1.5 million patients. Of those, approximately 500,000 had a new incident AF diagnosis. Those patients had at least one AF-related visit in the one-year post-incidents, and some of this gets to the complexity of care in the U.S. and where people go. There was 100,000, where we had one, we had a patient with continuous enrollment since six months pre-one-year post, so we could really understand if this was new and where they went, was 40,000 people. And then we excluded those with unknown information in their baseline characteristics. So the final workable population was 37,000 patients. Sorry, this is a little bit busy. We tried to make it a little smaller, but it contains a lot of relevant information to interpreting these pathways of care and where there may be opportunities in the United States to improve. This is patients in which EP was involved in the pathway. This is a pathway with cardiology, without EP, and this is a pathway of AF care that excluded both EP and cardiology. You can see as age increases, patients were less likely to see an electrophysiologist or cardiologist. As the population became more populated, with females compared to males, there was less association with a pathway with EP or cardiology. Unfortunately, we continue to see areas of historic discrepancy. The population was more white that saw EP and less often black. Income played a role as well. Patients that saw an EP tended to have higher income levels than those that didn't see EP or cardiology. We saw a little bit of mixed association with education, but tended towards higher education than those that saw electrophysiology. Further information, there was a pattern in which the Midwest population did better compared to others. Patients in the Midwest area, that may be the large shadow of DJ Lacchi Reddy and Andre Natale in this area, but they got a lot of people in the EP compared to the other areas. And then where patients first presented influenced care. Those that went to the emergency room were less likely to see electrophysiology or have an inpatient first visit. Those that were seen in an outpatient tended to see more electrophysiology. The physician type at that very first visit also influenced that. Obviously, cardiologists early on versus primary care, those patients that saw primary care as their first provider were more likely not to be referred on compared to those that saw more advanced providers. And you could see a mix, but patients that had earlier atrial fibrillation, paroxysmal atrial fibrillation were more likely to receive an EP referral. Patients were sicker based upon this health index score, and those that didn't receive EP referral, they had higher CHADS-VASc scores than those that didn't see EP or cardiology. You could see a mix of medication use, but you can also see how it can be more concordant with the disease. Those patients that saw EP or cardiology were more often on an ACE inhibitor or beta blocker where digoxin and drugs that we usually associate with a second line or third line drug were more often in the group that didn't see either. So the 10 most common pathways in the United States are cardiology only, 40%, PCP, 32%, cardiology going to primary care physician 11%, primary care physician to cardiology 10%, EP only 5%, cardiology to EP 3.2%, and EP to cardiology often going back for long-term care is 1%. And then all of these representing 2% or less. If we look specifically at the pathways in which EP was involved, EP only made up 25% of that, so we're good at keeping our patients. Cardiology to EP, 16%, EP to cardiology, many of us have worked in large networks where the cardiologist wants the patient back after we offer an opinion. That's 9%. PCP to EP, 7%, cardiologist, PCP, EP, 6%, and so on. But the most dominant being these three that account for the majority. So these are the pathways. We see they're multivariable. There's multiple pathways, and this is the things that predict that. As patients get older, and on this side you're less likely to see an EP, this side you're more likely. You can see as you get older, you're less likely to see an EP. You can see as your income, and these are in blue, it's higher, you're more likely to see EP. Everybody did worse than the Midwest in getting people to EP. More often to see EP if you're paracetamol versus persistent. And another trend here that's significant is the sicker you became, the more likely you were to see EP. And I think that message is critical when we see some of the impact of EP-related care. But when you see an electrophysiologist, you're over two and a half times more likely to receive an anti-arrhythmic drug. Some of that's intuitive, they're more symptomatic, but some of that is also we have a specific interest in these patients and in their management, you're two and a half times more likely. And you're over 20% more likely to be placed on an oral anticoagulation. And what's really gratifying is when you take historically marginalized groups, once they see an EP, that goes away. So as EP, we're doing a good job in addressing some of the disparities in the United States, and I think we need to get that message out that it can be done in other specialties. So multivariate analysis between EP and AF-related outcomes at one year, you can see we did not have an impact on AF-related hospitalization, but we had a significant impact on patients that returned to the emergency room. We did not have an impact on heart failure hospitalization. Some of that may be related to the fact that we were seeing healthier patients. But we had a significant trend towards a reduction in stroke. But if you look at patients that were over 80, in which we'll be more likely to see events at one year, patients over 80, we can see the influence of AFib impact AFib-related hospitalization, impact AFib-related ER visits, did not influence heart failure, but significantly impacted stroke. And when you think of the demographics of the U.S. where people are with AFib, we can make a significant improvement with AFEP being involved in the care. So in conclusion, this analysis of a diverse American population, there was significant variability in the care pathways that followed index diagnosis of atrial fibrillation. This work reflects barriers that, reflects barriers exist to assessing specialized EP care. Only one in five patients with a new diagnosis of atrial fibrillation had consultation with EP within one year. And that's despite new randomized control evidence that suggests early management with Rhythm is better and can significantly improve AF-related comorbidities. Those patients with an EP care pathway were more likely to be white, male, younger, healthier, with greater income. Those patients without an EP are cardiologists, and their pathway are more often black, older, and lower incomes. Groups historically less enfranchised are less likely to receive specialty care. But as I mentioned, despite these social determinants and barriers, once they reach EP, we do a good job. Prescriptions of oral anticoagulation and anti-rhythmic drugs significantly improve. Those patients with an EP care pathway had a greater likelihood of receiving anticoagulation and more intensive rhythm control. And in those patients, it led to lower AF-related hospitalizations and a trend towards lower stroke rates. But in the highest risk patients, it significantly impacted all of those, AFib, hospitalization, emergency room visits, and strokes. So you might be thinking there's not enough of us to do this. We released in this meeting the criteria of how we can do this as a cooperative in forming Atrial Fibrillation Centers of Excellence. We have to identify the right person at the right time. People need early management. They need to be seen by the right provider with each team member from primary care, cardiology, and electrophysiology playing key roles early on and for the maintenance of the disease. And it needs to be in the right place with a center dedicated to meeting guideline concordant care, multi-specialty care, and committing the resources for availability of the best care and technologies. Thank you very much. What great work, Dr. Bunch. Thank you so much. And thank you for the work put into that paper that came out this week. It's an absolutely great read. We all see here, yeah, right place, right time, right provider is the goal. But as you've shown, there's these factors, these root causes that's not happening. Is there something we can do now, actionable, possibly utilizing the EMRs to help streamline those patients into the EP space? Yes, and we're working on that. So Heart Rhythm has initiated a group called COMPASS. And it's where we end up bringing a dashboard into your EPIC system, and it helps direct guideline care. And we're testing it in three institutions right now in the U.S., at Duke, Cedars-Sinai, and St. David. You know, the methodology paper should almost be done, and we're looking for a late breaker at the Heart Rhythm next year to show that we can make an impact. So I think there's things we can do. Right now, we can be creative with education. The cell phone work was fantastic. We can reach our patients. We can talk to our primary care physicians. In Utah, when we did this, we met with the primary care physicians of Intermountain Health Care. Ninety percent of them said early treatment for atrial fibrillation is a beta block or an anticoagulation, and the other 10 percent said ablation. And we're like, there's a lot in between those two. And so we can begin to educate. But we're hoping, because of the complexity of care and the chronicity of care, that we can begin to automate some of this and make it easier, just like Merge and Pacemate do it with implantable devices. We need to do some of these things to help us out and remind us. So more to come on that. The intervention arm of some of this data is out. The criteria data, what we need to do to get better, is out, providing people a framework. And the quality, the QI committee is actively looking on implementation science and how we can make sure what we put out there is impacting things in a meaningful way. So, yeah. Thank you. Thank you again. Are there any other questions? Well, you're just at time. So thanks to all of our presenters. Some of them are still around here, so please engage with them if you have any further questions. Thank you for being here. Have a great Saturday night.

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