Good morning everybody. My name is Amin Alamad from Austin, Texas. Thank you for joining us in this Rhythm Theater sponsored by Humanetics. The title is Implementing Efficient Workflows for Atrial Fibrillation Ablation. We have a fantastic faculty, Dr. Ono from Japan and Dr. Doshi from Arizona. And so we're all going to hopefully be able to give you some of our perspectives on how we implement an efficient workflow in our EP labs. And of course if there's questions or anything, please don't hesitate. I think there's a QR code and the questions will show up on the iPad. So we'd love to hear from you if you have any questions or concerns. So with that, maybe I'll go ahead and start and then we'll go from there. All right. So as we all know and as we've seen, in fact as we've seen particularly in the last year or two, there is a pretty significant increase in volume in the EP lab in terms of the procedures that we do. We're seeing many, many more patients with atrial fibrillation, many more patients that need treatment, and it does not look like this is going to slow down. It really looks like we're continuing to see a pretty big uptick in these procedures. Now as we think about procedures, and we don't like to think about this as doctors, but there's a lot of costs associated with these procedures, whether it's ablation equipment, anesthesia support, or nursing costs, and all of these kind of factor in. And we think about efficiency, we sort of have to think about how they factor in together. And sometimes things are a little more complex in terms of the interplay, but it all kind of matters in the end in terms of trying to create a very efficient workflow. One of the challenges we have in Austin, and I'm sure other folks have a similar challenge, is our staff shortages. And so this is really an issue in terms of how we deploy our staff and what our staff does for us. So who's doing what, when, and how they're doing it in order to keep us as efficient as possible so that you're not sending somebody off, for example, to check on a groin or to do something. There's a lot of these types of things that we have to we have to now care about. So one of the ways people have talked about is sort of, you know, well you can always put in, and I'll just address this right away, because I'll address this and then we'll get into some of the stuff with Vascade and Humanetics. But you know, one thing is, hey, just put in a figure of eight stitch. And you know, our experience has been very mixed with this in terms of patients having a fair amount of discomfort. But what I found out recently was it was not just the patient discomfort that was the issue, but it was how we deploy our staff. Our nursing director said, look, if you put in a figure of eight, I need to send a nurse to check on that patient very frequently, because sometimes these things become loose, and sometimes they bleed, and sometimes there's issues with them. There's all sorts of other issues that you'll hear about. The other problem with them is that you know, you could inadvertently discharge a patient with a figure of eight suture. And I won't say that that's happened, but I'm sure that's happened. And we've also seen as these sutures get a little loose, bleeding can occur. So you really do need to deploy some resources in order to make it happen. I've not seen anybody nick an artery, but I'm sure somebody will figure out a way to do that as they're trying to put in a figure of eight suture. So that's the other concern that I have personally about these types of devices. Well, so we've been working with the Vascade system for many years now. In fact, we were part of the early IDE site. We did the first study with Vascade. And it's kind of an interesting study, because as a big group like ours, and I'll show you some of that data, you know, when a study is going well, we enroll, and we really love the product. If we don't like the product, nobody wants to enroll. And this is a product that everybody loved. So the Vascade system, just for those of you who don't know it, it's an extravascular design. There's a little bit of a disc, and the disc gets pulled up on the top part of the vein. And then you deploy a collagen plug, and that collagen plug stays on the outside of the vein. So it does not end up intravascular. And it basically mechanically pushes down, essentially creating some hemostasis. But also because the collagen plug is thrombogenic, it allows that tissue tract to thrombose. And therefore, you can stop the bleeding that comes from the puncture site fairly rapidly, and allow the patients, importantly, to ambulate quickly. And there's a lot of benefit to that, which I'll show you. So the Ambulate Pivotal Study, which again, we participated in this. And one of the remarkable things I keep telling people about this study is that we couldn't get enough. The patients wanted to enroll. The doctors wanted to enroll. We really liked the study. So this was a 200-patient study, and it was randomized one-to-one between manual compression and between use of the Vascade MVP device. And this was done back in the 2019 era. And this was enrolled faster than any other study I've ever participated in. Literally, in a few months, the study was complete. So the endpoints in the study were time to ambulation, complications at the entry site. And there were other secondary endpoints, time to discharge, eligibility, time to hemostasis, and patient satisfactions, and so forth. There were 13 sites, 28 investigators, so a fairly wide variety of users that used the device. And this is what we found. We found that the ambulation time was substantially lower. So there was a significant reduction between your sort of bed rest with standard manual pressure, which at the time was about six hours. There was variability. Some folks would do four hours, but all the way down to about two hours. And I can tell you some people were even less than two hours. So that was fairly important. That was a significant finding in the study. And then in addition to that, what we found was the time to discharge eligibility, if you did want to discharge those patients early, that was also something that was impressively different between the two arms. Now, the part that I think matters the most, to be honest with you, the part that I care about the most is actually improvement in patient satisfaction. And that was off the charts with the study. So patients do not like laying flat. And I would challenge everybody in this room to go lay flat on one of the hospital beds for six hours and not move and not wiggle and not move your leg. And it's really, really painful on your back. So the patient satisfaction was enormously better with this. But also importantly, we have objective measures that we use less opiates when we use the device, meaning the patients were not asking for pain because of their back. They were just saying, hey, I'm happy to be by the time they're awake from anesthetic. They can be up and around, essentially. And I did want to give some kudos to the hemanetics team with the Ambulate study. So there's very few companies that will take the time and commitment to do really good clinical science and follow through with things. And so the Ambulate pivotal study was the first study. And then after that, in large part because the investigators wanted to continue to use the device, there was the Ambulate CAP study, which was the Continuous Access Protocol. And that was published in JCE in 2021. But after that, there was a series of studies that were both retrospective and prospective studies examining the use of the device for same-day discharge. And those studies have now been published. But again, I just want to say that's impressive that that evidence has been collected and that people have actually done these studies. So we've shown that the device is safe for same-day discharge in these types of patients. And then lastly, there was an Ambulate economic study. Because the problem is now you're introducing a new cost to the EP Lab ecosystem, the cost of the actual Vascade device. And you have all the administrators who sort of say, well, this costs $200, this costs $100, this costs whatever. And how does that cost add up? And how does that cost benefit me as the administrator or the hospital? And the end of the day, as I told you, it's a complex interplay. But in the end of the day, you're freeing up people that can actually do other things, turn around your lab, and you're also helping patients become more happy and satisfied. So there's definitely a benefit to the EP Lab, the electrophysiologist, most important benefit to the patient, a benefit to the staff. They appreciate it when they're not having to hold the groin and check the groin. And a benefit to administration, an actual, believe it or not, cost reduction rather than increase in cost. We've talked a little bit about figure-of-eight suture. And we've talked about how, yes, they're cheap. But in reality, they're not that cheap, because you really have to send somebody in to keep checking them. And you have to make sure that somebody doesn't get sent home with one of these figure-of-eight sutures. And you end up having the patients not so happy with you. The economic impact of using the Vascade device actually turns out to be pretty good. And there may be even a potential savings per patient once you use this, because of the ability to free up individuals to help you with other things. So the administration is happy with us. We're able to get good patient results. We're able to get patient satisfaction up high. We're able to free up staff that they can utilize for other things, like turning over the room and getting the room ready for the next patient. The benefit to electrophysiologists is patients are now happier. I mean, honestly, the worst thing in the world is when you see a patient, you've done an afib ablation. Now, they say, you know, doc, I would do it again, except I can't lay flat. And it used to happen. They would say, I just can't lay flat. You need a redo. Well, I don't want to do a redo, because I don't want to lay flat. But now, we don't have that problem. Now, they're willing to do it. It was so easy. It was so straightforward. So they're happy to do that. And patient satisfaction matters a lot to all of us. And then lastly, same-day discharge for these types of patients. Again, these are patients where we're showing time and time again that you may be able to discharge them the same day. The procedure is very safe to do. And the patients appreciate going home and sleeping in their own beds. Procedural workflow for the EP lab staff is improved. Again, not having somebody go there and pull the sheath. We used to have somebody go down and pull the sheath after the ACT. They'd have to check the ACT, keep checking the ACT, pull the sheath. We don't do that anymore. We can deploy this whether or not we reverse the heparin. And we can deploy this and not have somebody need to check on the groin unless there's an issue. And then, of course, obviously, the patient benefits. I think, again, to all of us, matters the most and resonates the most that patients are happier. And they use less opioids. And we don't need to put in Foley catheters. So all of this type of stuff matters in the end. When your patients are happy, you're happy. Now, just to give you an idea, the sheaths are getting bigger. So we're starting now in the era of pulse field ablation. And so the sheaths are getting bigger. The delivery systems are getting bigger. So there's a bigger solution now from Vascade. This is the Vascade MVP XL, 58% more collagen, a little bit of a larger disc so that when you pull up against the vessel wall, it doesn't slip through. But importantly, the XL system can cover a fairly high range of sheaths, up to 10 to 12 French. And we look at the common sheaths we're using now. It is FDA cleared for all of those sheaths. And it's currently under investigation for even bigger sheaths, which I think you'll see in the future as things go. So I'll conclude here. And then I'll turn it over to my colleagues. I think we're seeing a continued rise, continued capital equipment, continued throughput issues. More patients are needing our procedures. We're still fighting with nursing shortages. We really do need to become more efficient in the EP lab. And one way we can do that, while also improving cost reduction and patient benefit, is to get these patients ambulating quicker. So with that, I will say thank you. And I will turn it over to Dr. Ono. All right. So hi, everyone. I'm Maki Ono from Kameda Medical Center, Japan. So I am going to talk about how Baskage can help workflow to the different population and how should we be careful about to the special population. So I work at Kameda Medical Center near Tokyo, two hours. And we have like 500 ablations per year. And then 350 of them are AFib ablations. So why am I talking about Baskage? So I did an EP fellowship at Cleveland Clinic. And during that, my fellowship, Baskage was launched in the US. So I really liked it. So when I returned back to Japan, I wanted to use Baskage to my Japanese patients. That's why I initiated experience with Baskage at Kameda Medical Center. And I helped Japanese physician to educate, you know, how to use Baskage and tips for it. So I think two things are very important to use Baskage. The first one is obtaining very good access using ultrasound safely. If you screw up that at the beginning to the puncture with a puncture, you will screw up at the end with hemostasis. And the second thing is post-procedural care for the patient. So I created the brochure for the patient for the growing care at home. And I created a protocol at hospital in Japan how to use Baskage. So we have to make sure all the physicians, the nurses, and the patients have to be on the same page for the growing care. And I'll tell you why later. So I spread awareness of our experience to Japanese EP doctors. So let me tell you quickly about our market in Japan. So we do 90,000 ablations per year. And we have 520 hospitals where we can do the ablation. And then we have about 1,500 EP specialists, including myself. And then ablation, yeah, we can do everything else. We can do RF, we can do cryo, and we are starting PFA just like the United States. So the details of the ablation is AFib is the dominant. AFib accounts for 75 percent and it's the dominant, just like the United States. So if we can do the same procedures and do the same type of the disease, what should we be careful about? Because Baskage is easy and it's simple. What do we have to be careful about? So it's here. It's the size difference. So we do have skinnier patients. So the left one is my scrub at the Cleveland Clinic, excess. And the right one was the biggest, the largest scrub I could find at Cleveland Clinic. So we definitely have the size difference. So back in the U.S., I didn't hear about anything about tissue tract. Have you ever heard anything about tissue tract when you use a basket? So here's the skin and here's the vein. You have a skin puncture site and you have a venotomy site. So this distance is called tissue tract. And then when you use a basket, you should have tissue tract more than 2.5 centimeters. Otherwise, your 1.5 centimeter collagen patch will pop out of the skin. So our patient body size is smaller. And then we definitely have the patient with skin distance less than 2.5 centimeters. And I measured it. The average for my patient was 2.88 centimeters. So it's close to the limitation. And then basket says we should be cautious about the patient with BMI less than 20. And our average BMI was 23.5 for Japanese population. So we definitely have very skinnier patients. So can we use basket for this type of population? Yes, we could. But you just have to be mentally prepared what's going to happen to when you use it to the skinnier population. If you use it to skinnier population, you might see some small folded white collagen coming out of the skin. As soon as you see it, if it's still folded, you can just press down the green one and push it underneath the skin and everything is set. You can still use it. That's it. If you're not mentally prepared and if you don't care about the green one, just deploy the collagen. And if you see the folded collagen outside of the skin, and it will quickly start to expand with blood. So if you see all the expansion coming already there, it's very difficult to press it down. So just be prepared. You might see the folded collagen. If you see it, you just press it down, and you're all set. So as the first speaker said, we did use the manual compression. It was a gold standard, but it requires long bed flat time. And then back in Japan, the nurses cannot pull the sheath. They cannot hold the pressure. It's our physician's job to hold the pressure. So workflow is different. It's a lot of work for us. And we do use a figure of eight. As we know, it's cheap, and it does give us a good hemostasis. But still, we ask the patient for the six hours of the bed rest. So why did we adopt that schedule? Because we wanted to have early ambulation for Japanese population. So we do know that we have the good evidence, five studies, even though they don't include much Asian population. And we wanted to have better workflow, especially in the environment that we cannot get the nurses to hold the pressure. And we wanted to have a Japanese patient better satisfaction with BASC-AID. So as he said, BASC-AID is simple and easy to learn. So we have experience that this later is very initial experience. When we started, the 63 patients with BASC-AID MVP, the age was 68. 71% was male. BMI for AFib limited was 25. Trans-BASC like this, and the patients are on various anti-coagulation. Half of them are persistent. Half of them are paroxysmal. We did cryo, RF, and then the average number of the sheaths was 2.6 for this population. And then this is the protocol at our hospital. We use the autosound-guided puncture, and we use the sterile strips and tether them with pad and the simple gauze and the mild tape. No pressure dressing like before. And after the ablation, we'll ask the patient to stay flat on the bed for two hours, and we, physicians, have to check everyone. And then if everything is clear, we'll ask the patient to sit on the bed for one more hour just to make sure, and then they'll start ambulate. And the patients are happy about it. So so far, among these 63 patients, we have zero major vascular access complications so far, and this number is increasing, keep increasing. I have more than 300 patient vascular uses, and nothing happened for the groin. No major complications so far. So, and also, what about the patient satisfaction, especially for the redo ablation case? I will tell you, very special case. This is a male patient in his 30s. He's kind of arthritic. His BMI is 20.5. So he had ablation for premature ventricular contraction. So what is special for him? He is my husband, and he himself is a cardiologist. So he knows what puncture means. He knows what the hemostasis means. So when the first time he had ablation, well, I did the puncture, and I did the hemostasis. So when he had the first time ablation, we didn't have basket. So I punctured very carefully, just as I do for the other patients as well. And then I did, you know, figure of eight suture, and I hold the pressure very nicely, just enough time. I thought that was enough. But after the ablation, he had extensive bruise, just like the blue line you can see. He didn't complain on me, but anytime I saw his groin at home, I felt sorry for him. So, and unfortunately, after years, he had the recurrence of premature ventricular contraction. So he had a second case. So now we have basket. So I did the puncture, and I did the closure with basket MVP. So he was much happier with smaller, light blue, you know, minimum bruising, less pain, you know, shorter bed rest. And then he also had the same day discharge. So he was much, much happier about it. Yeah, so here back in Japan, we don't have that much pressure on, you know, like minimizing the hospital stay, like the same day discharge in the United States. But with basket, we started, we changed our workflow from next, next day discharge, which is very much average for Japanese patients to be discharged, to shorten one day, and then to the next day discharge. So we did not see any increase of readmission rate. We did not see any increase of, you know, unexpected hospital, you know, visit within one month. We didn't see any difference of the extension percentage of hospital stay. We did see the increase of the patient phone call to the hospital. So we have to educate more to the patient. That's what we learned. But that's very important. We can reduce the hospital stay as well. So in conclusion, everyone, we can use special population to the, you know, patient whose tissue tract is very short and whose BMI is less than 20 with careful consideration. And our adoption was focused on early ambulation and a better workflow and the patient satisfaction with all of which were successful. And we so far have zero major complication at our hospital. So in our experience, the basket is simple and easy to run and the patient satisfaction is important for vascular closure post-procedure care, including for redo patients just like my husband. All right, thank you. Well, good morning everyone, and I can't top that as far as a story. I would have been left to be bled out on the table if my wife was doing an ablation. So before I get to my topic, I actually did want to make a couple comments. You know, the focus of this discussion is approving efficiencies, and I think it's very easy to get sort of the fundamental message of, well, you know, patients are in and out of the hospital faster, and there's a big economic driver to do so, and all that is absolutely true. But I can tell you that it does translate, and when you are more efficient and your patient throughput is better, it actually does translate to outcomes. And so, you know, it's not only experienced like when we implemented the system, which if you all remember what happened in 2020, right, going from about 60%, 65% same-day discharge in our AFib ablation patients to being shut down from the pandemic, to being, if we were going to do any case in our entire cardiovascular service line, being able to discharge patients the same day, literally going instantaneously to essentially 95% same-day discharge with the implementation of this system, was very powerful. But then we saw, so this was almost by necessity, right, but then we see downstream that, oh wait, all the patient satisfaction issues, all the patient cost issues, and oh, we had less vascular complications too. So again, efficiency outcomes, they kind of go hand in hand, and that's kind of my segue for talking about esophageal cooling. These folks have to talk about something that actually is, I mean, let's face it, there is competition in the market, everything from figure of eight to other closure devices. This device, there's no competition in the market, and I just don't understand why this device isn't widely utilized. So that's me, and yay, I don't know why that's there. Okay, so we're a, just as a background, so Honor Health, we have a hospital network of now nine hospitals and now nine electrophysiologists, and you know, we're growing and we do lots of procedures like all of these folks, and that's nothing different, but I actually wanted to piggyback on something that Amin touched on. You know, he mentioned like how easy it was to enroll, right, because it was such a great product. You know, electrophysiologists are herding cats, right, and if you're running a group of electrophysiologists, you can't get anybody to do the same thing or at least to agree upon the same thing. Everyone has their individual differences. When we instituted this in our system, it became uniformly adopted across our entire network, and so that's the important point I wanted to make, and still to this day, for every single radiofrequency case at Honor Health for atrial fibrillation, we are doing with esophageal cooling, and I just can't understand why more people aren't utilizing this. Anyway, so esophageal injury is obviously what we think about, talk about, and it's, I mean, let's face it, it ranges. It ranges for, quite frankly, pain that we thought or attributed to pericarditis back in the day, and implementation of this technology. It's like, oh wow, maybe that was a lot of esophageal pain that we were confusing as pericarditis, but certainly you can go from just, you know, routine surveillance, esophageal symptoms, if you're looking, finding esophageal lesions, but quite frankly, the boogeyman of EP, right? Atrial esophageal fistulas, and if anybody's had a fistula, it is frightening, and it requires urgent intervention, and it is the thing that we still lose sleep about in the EP community, right? As we all do, right? And so, and it is still the boogeyman of EP, and thinking about incidence, I mean, do we really know what the incidence is? I mean, how much does GI prophylactic matter? Does it change with different energy sources, right? I just want to emphasize the point, there are still so many unknowns, and so we still think about this, and you all have taken care of patients. Patients look this stuff up, and patients still bring this up when we talk about doing a catheter ablation. So, lots of strategies to address the prevention of esophageal injury. Obviously, we focus on, in radiofrequency land, reduction of ablation power and contact force, or increasing force and decreasing duration, you know, the high-powered short duration strategy, and switching to mostly resistive heating. Anyway, you slice it, there are biophysical ways that we can sort of try to mitigate our injury, right? GI prophylactics, whether it's proton pump inhibitors, combination with barrier antacids like carafate, the industry, or I should say, the community standard for a long time has been temperature monitoring, and does, do you all feel comfortable, those of you who haven't employed cooling, with temperature monitoring? Now, there's very little data, but there's obviously huge amounts of limitations on just where that probe is, how it's measuring, how it's complete, whether it's anterior or posterior, and obviously you need to be anterior in the esophagus, or in the esophagus to get accurate posterior or left atrial measurements, right? Obviously, there's more expensive ways to do this, more complete ways of doing this, but the bottom line is there are limitations, and the only series that I'm aware of that's actually compared luminal esophageal temperature monitoring to not actually showed a higher incidence of fistulas. Now, it's not great data, but I mean, the idea is, do we really have confidence in this strategy? Alternative energy sources. I mean, it is fair to say that there does appear to be a signal with PFA that there is less esophageal injury, and there is a degree of tissue specificity with PFA, but let's face it, we all are still learning about these energy sources. We still are realizing that there are differences in waveforms, there are differences in catheters, contact force matters, and oh, by the way, there is a thermal footprint with PFA. So, we have a lot to learn about this, is my bottom line. There's a lot of unknowns. So, esophageal cooling has been around for a little bit. I mean, there were sort of early sort of thoughts about, oh yeah, if we just shove cold saline or cold water into the esophagus, it might be a good strategy, and so that kind of led to this whole development. So, this is the ENSO ETM system, and many of you are familiar with this or seen it or have seen it at the booth or whatever. It's just nothing more than a tube, a balloon, if you will, in the esophagus that you're circulating cold saline through. And so, you bring the temperature down to four degrees in the esophagus. It's a closed-loop system, so nothing is getting in. There's still an inner lumen, so you have an NG tube, if you will, for secretions in the stomach. It's very easy. It doesn't interrupt workflow if you're putting patients under GA, which of course in the U.S. the majority of patients are. It's just very easy to adopt. So, is there good clinical evidence? And I think the answer to that is yes, and I'm going to go through this rather quickly, but initially the IMPACT trial, which I think is very powerful, a one-to-one trial with single-point temperature probe, which is quite frankly still what the majority of folks are using, temperature monitoring, that's what they're using. 120 patients underwent endoscopy after their ablation, and the results are actually quite staggering, right? A hundred percent reduction of severe lesions, and that was the per protocol analysis, an 83% reduction in all lesions, so it had a very significant effect at reducing esophageal injury. Now, this is not fistula, obviously, and obviously you would have to do a trial with tens of thousands of patients to show a difference. Actually, you'd have to do a trial with hundreds of thousands of patients to demonstrate a difference in esophageal fistula formation. So, speaking of, so this is a very interesting retrospective review. Now, it is a retrospective review, and it does, you could certainly say, that this might obviously have some confounders, like different approaches for ablation over this time period. This roughly spans an area of, you know, standard contact force versus more high-powered short duration but anyway you slice it, in a very large series, you know, 11,000 patients without esophageal cooling, 16 atrial esophageal fistulas with radiofrequency, as compared to in over 14,000 patients, zero. Now, I'm reminded, or I was recently reminded, that there actually was one, and the esophageal balloon was not down in the esophagus, so there was no esophageal cooling in that one fistula. Anyway you slice it, effective esophageal cooling appears to significantly reduce any real risk in, you know, retrospective or registry analysis, and now, quite frankly, there have been hundreds of thousands of patients that have been treated with esophageal cooling, and we do not see fistulas. And that's in a time period where many of us, so, I mean, whether you're having an ablation with me or a lot of my folks at Honor, but I mean my colleague across the way here, I mean, their center is very aggressive on the posterior wall, as I quite frankly think we should be, and we just don't see, forget fistulas, we don't see complaints of esophageal pain or injury, and that's very comforting despite the fact that we're ablating more, we're seeing less, or seeing none, quite frankly. So post-ablation symptoms, and this is something that we actually looked at as well in our population, but this was a study that looked at symptoms or reports of chest pain in essentially a hospital registry before and after adoption, and 183 patients, 90 patients were treated with temperature reduction via this system, and 93, or temperature monitoring versus 93 with esophageal cooling, and you can see the significant difference in just complaints of pain. And so any way you slice it, whether you're looking at surveillance in esophageal lesions, whether you're looking about complaints of esophageal pain, these are markers of esophageal injury, and if we believe that esophageal is the precursor that disposed people to the risk of developing esophageal fistula, this makes me feel very good and it's been our experience as well. Now again, the focus of this meeting or this session is on efficiencies and does this approve efficiency and I would say unequivocally yes. Now for myself, okay, I'm ablating the posterior wall all day and so I'm not looking at temperature monitoring and I don't have to move the temperature probe up and down and I'm not overly concerned or I'm not now worried about it as compared to seeing a temperature rise and then waiting or just being in the habit like we all did when we started doing ablation, is moving the catheter around to make sure to mitigate or to decrease that potential risk of lesion stacking and increasing thermal injury with ablating in close proximity to each other. And so for this reason, if you're not worried about it and you're not constantly looking at temperature rises and you're not stopping the procedure or you're not moving the catheter around the posterior wall, you're going to be more efficient whether it's posterior lesions to do pulmonary vein isolation or doing full posterior wall isolation like many of us do. And it's not just the efficiency piece of it. If you're able to really closely navigate your catheter and move it around, are we going to see less gaps? Does this approve our actual efficacy of the procedure? And the answer actually might be yes. And so here is a retrospective review of over 500 patients, radiofrequency ablation, three hospitals. You can see roughly half and half temperature monitoring versus esophageal cooling. You can see the freedom of AF, so this is real clinical results, was much better if you did esophageal cooling. And so yes, we're concerned about esophageal injury. And yes, I'm still deathly afraid of esophageal fistulas. But this improves your efficiency to get a better result in my mind. And intuitively, it makes sense, right? And usually in medicine, if it intuitively makes sense, it's probably going to be true. And this relates to the idea of being contiguous in your lesion set, which is incredibly important and by the way, is not going to go away with PFA. As you're going to hear more and more, including at this meeting, about the leaks related to, in fact, if anything, it might be increased with PFA. But certainly in radiofrequency, we do want some overlaps. We want contiguous lesions because we want dense lines. We want to, we don't want reconnection or proarrhythmia after our procedures. So some additional data that I think is relevant. Freedom from alarms. You know, obviously, I mean, I can't stand this. And it's not just for point by point radiofrequency. One of the big reasons we adopted this quickly was when we were using actually the laser balloon, which if any of you have any experience, you get a temperature rise, what do you do? You just sit and you wait and then you start again. And it just was very disruptive in our workflow. So that was wonderful. Improved same-day discharge. Obviously, if you're getting your patients done quicker, if there's more efficiency, you can get them out, right? And actually reduction in fluoroscopy. Are you more comfortable with using 3D mapping only if you are confident that you're not causing temperature rises, that you're confident that you're not causing esophageal injury? You can be confident with very discreet catheter manipulation. And so you can reduce the fluoroscopy of these procedures. So there are some recent updates that I want to highlight, just one important takeaway from the updated consensus document in 2024, Combined Society. Esophageal cooling has been shown, not really equivocal, has been shown to reduce the risk of severe esophageal injury, which includes fistulas, of course, during atrial fibrillation of catheter ablation. It's a pretty straightforward statement, but it is very powerful that it made it to a consensus document. My experience, I basically have already commented on, and again, previous approaches I think fell short. The temperature alarms drove me crazy. You know, like every other electrophysiologist that does ablation, I suffer from ADHD, unlike all of you. And it's, let's face it, when you have to wait for anything, it's infuriating, right? And I mentioned the laser balloon experience. There's no learning curve to this. You put the esophageal balloon down. Every now and then we have an anesthesiologist that struggles initially in our experience. Now all of our EP lab staff know for the simple tricks of pinching the balloon so it's a little bit more rigid so that you can deploy it easy. It's simple. It's very easy to implement. So there is really no learning curve. And I mentioned earlier, and I want to just bring it up again, I will be the first person to say that I thought all these patients that, oh, they just have, you know, whatever instance you feel you have, oh, some post-procedural pericarditis, oh, it's so common. A lot of that went away when we adopted this. Hmm. So it wasn't pericarditis. It was esophageal pain. So in retrospect, I'm a little frightened by the fact that this was the case. And now prospectively, I'm very happy that we've implemented this technology. So some considerations now in the PFA world. And I think that obviously everyone is very interested in this. Obviously we've got great data and it makes sense for RF. But I do want to emphasize there is heating with PFA. And again, there is variability in that degree of heating depending on the catheter being used, the cooling that's involved on that catheter, the waveform, and the contact, which remember initially, a few years ago, we thought the contact didn't matter with PFA. Oh, we were wrong, right? So I think that we still have a lot to learn. And we will still continue to learn. But in my mind, it still makes sense to prophylax with these patients. And is it cost-effective? Well, if I'm increasing the throughput, I'm increasing the efficiency, and I'm increasing the efficacy, that's got to be cost-effective to the system. OK, so that makes sense. But I do want to, as a person that still does a lot of radiofrequency ablation, I don't think radiofrequency is going away. I think that there is going to be a large role for dual energy source. And for that reason, I think that this esophageal cooling still is going to be a very important part of our armamentarium. Not to mention the fact that, quite frankly, if I put my network hat on, and if I'm looking at cost margins for a procedure, radiofrequency versus PFA, well, we all know, right? I mean, it is more expensive to use PFA. Now, that's still, if it ends up being much better for patients, great. But I do think that we have to think about this prospectively to keep the lights on, right? So with that, I'll conclude. Obviously this has an indication for use in catheter ablation for atrial fibrillation to decrease your risk of esophageal injury, supported by a recent guideline consensus document. And I do think this really does effectively streamline the procedure and leads to better outcomes for our patients. And so with that, I'll close and thank you for your attention. Thank you. So I think we can get some questions, if anybody has any questions. One of the things that crossed my mind when listening to the two talks, one is, I'm glad my wife doesn't have PVCs. So you don't have to do it by yourself? I would not ablater, I'll tell you that. And then I think the evidence you showed is incredibly compelling, that if you're going to use RF, you better cool. I think that's pretty clear, right? So I guess maybe I can ask the faculty as people are coming up with questions, a little bit about figure of eight. My experience was very negative, but I still see people use it and they have little tools and little things for it. What has it been? Have you guys used it at all or anything like that, or what do you guys think? No, no, no, no, please go ahead. Okay. All right. Figure of eight, we still use the patient for the very, very skinny patient, like a BMI less than 18, and then subcutaneous tissue is less than one centimeter. For this patient, yes, we definitely still use the figure of eight, which is at least much better than the manual compression, I think. But it's like getting much lesser in the era of basket. How about you guys? So obviously in the era of uninterrupted anticoagulation before the widespread utilization of closure devices, of course, lots of experience with figure of eight. Experience with another suture mediated system, and actually I was going to ask you, yeah, figure of eight hurts. Patients hate it. You watch them longer. They're flat longer. Okay, great. I mean, it works. And obviously until XL, obviously we're using it for all of our large bore access, whether it was PFA, whether it was balloon, and certainly for appendage cases, right? And now we don't have to for that. But I'm curious, just related to suture mediated closure, I mean, we still have folks and we all have experience using devices like Perclose, and patients complain of pain with Perclose, and they don't with this. And so from my mind, that's actually also a significant difference, the patient satisfaction business. And you have more experience than me. It's also a little bit more of a complex device. So one of the things we do in Austin is, I don't know, when we finish the procedure, I just leave the room, and actually the tech uses the closure device, they'll close. And so I don't have to worry about it. And I have to say, I have a real confidence, at least with Vascade, that they can close it pretty easily, because it's such a simple, straightforward device. Actually, we've trained them to use ultrasound to see the disc along the vein. And so we know that it's foolproof. Vascade, I'm sorry, the Perclose, it's been hit or miss. And so we do use it in some cases, but there's been a few cases where they have not closed it as well. And it is a more complex device. And we did have a couple of people who had really some bad bleeding afterwards with that. I like your point about thin patients, too, because I'm not sure what to do with very thin people. But your point is correct. I mean, when we have seen that, we've kind of pushed it in a little bit, and that works really, really well. Yeah. Yeah. Let me see. There was a couple other questions here. I'm just curious about the esophageal cooling in terms of efficiency. So I've heard that. Actually, several of my colleagues have used it, Jason, Zagrodski, Javier Sanchez, they're big fans of it. How has that impacted your throughput? Is it really just mostly you have to stop ablating and then restart, or are there other ways that it's impacted? So in comparison to temperature monitoring, and it's hard to sometimes make temporal comparisons because there's also different technologies involved, right? But there's no doubt. So if you saw a temperature rise, you stop. And you wait. And your body would then move if it's point by point. But if you're using a one-shot, if you will, like the laser balloon, you're just stuck. And you just literally are waiting and nothing more. And sometimes, as you all are aware of, the worse the temperature rise, the longer it takes to come down. And we think that lesion stacking or temperature stacking is a big part of it. So yeah, that part of the efficiency piece certainly makes a big difference. It did resonate to me when you said EP attention spans are short. I agree with you. You get very impatient having to wait as the thing is beeping. There's a question here about any issues with the Vascade plug migrating out of the tissue tract since it has no anchor. That's true. The Vascade plug does not have an anchor. And I have to say I've not seen that. I've never seen that at all. In fact, again, we've used ultrasound to look at it being deployed and have not ever seen it migrate out. Now, again, in thin people, sometimes you do have to push it in. I don't know, have you guys seen it migrate out ever? So full disclosure, this would be off-label usage. So before Excel, right? So we would still use MVP and larger bore axis because it did work. And you can see migration out. And we've done even some kooky things with even really, really large bore axis like leadless. And so we have seen the plug migrate out when it was an off-label use. So having said that, it's not an issue anymore, obviously. And what we did then, and now it's still an off-label use with really large bore axis. Patients are sleepy for a little bit after their anesthesia. And so a figure of eight in a very obese patient with large bore axis is actually helpful for half an hour, an hour for everything to sort of clot off. And then you cut it while the patient is still sleepy. And that sort of worked. And I'm completely off the reservation now. So I shouldn't have said that. And sorry. Sorry, guys. Let me actually ask you a little bit about that. Well, I actually only asked Dr. Odom because I was in Japan not long ago. And we use a lot more general intubation, complete general anesthesia. In Japan, there's a little bit more variability. They're definitely getting deep sedation, but it's not necessarily intubation general anesthesia. And so they recover a little differently than we see in the United States. And how has that played a role in terms of when you close people with Vascade versus the other techniques? Well, yeah, fortunately, at my hospital, Kameda, we can do all the procedures under general anesthesia. But before that, I was doing the procedures without general. So yeah, for that time, well, patient has a pain, definitely pain for the other type of the suture, you know, mediated closed devices. But with Vascade, no pain at all. Yeah. I've always thought of it as sort of, you know, when they're general anesthesia and they're waking up, you can lay them flat and the back doesn't really bother them as much. Or if it does, they don't really perceive it because they're still waking up from general anesthesia. But if it's a little bit lighter, then that really gets them antsy and they start to move around a little bit. And that's discouraged. And so having a short period of time to get people up and around, I think, is just so valuable from that perspective. The other thing you said, which was interesting, was COVID. And so for us, that was putting gasoline on the fire. We started using the Vascade device right before the pandemic. And then when the pandemic hit, patients came to us and said, we don't want to spend the night in the hospital. The hospital is perceived to be a place you do not want to spend the night. But there was some urgency in doing these procedures because they were fairly symptomatic and they wanted their AFib taken care of. And so in many ways, it was a perfect storm because we had now a solution to safely close the groin, get them up and discharge them the same day. So that was really, I think, in many ways, one of the bright spots of the pandemic was the Vascade device. I mean, it was no doubt. And it translates to, it turns out that efficiency and throughput make a difference in outcomes. I mean, you all are familiar with the data. I mean, for us, it was an absolute. We could not do patients unless they were going home same day, or they were anticipated to go home same day. So we were either going to treat patients or we weren't, right? You all have seen the data about the increase in cardiovascular mortality due to the pandemic. Oh, it wasn't related or very much a small part was maybe some increased thrombogenesis and increased incidence of MI or whatever else. No, it was patients not seeking attention or patients not able to be treated, whether it was their PCI, whether it was their TAVR, whether it was their AFib ablation. And so, you know, again, these things translate to much more favorable large-scale impacts on our system and again, for our patient population. If there's no more questions, maybe we'll have everybody give some final thoughts and kind of close the session. My final thoughts are really thoughts of gratitude towards Humanetics, not for sponsoring stuff like this necessarily, but for doing the science behind it. And I think people don't get enough credit for that, that you guys really took it carefully. You did all the correct studies and really took this technology, not just because somebody said it was good, but you really studied it in a randomized fashion. We understood how we can benefit from it. So I give you guys kudos for that. Thank you. So I'll invite my colleagues to give some final comments. All right. So my final thought, I really, you know, appreciate BASC-AID, but for the Humanetics people, we want to have like a shorter BASC-AID for skinnier patients, please, please. I guess my parting shot would be let's go back to the science, sort of piggybacking, but the basic science. We will not forget the physics of electrophysiology, right? And so stay tuned. There's going to be more data looking at these thermal footprints for whatever energy source, but certainly across pulse field ablation, which is still 90% of what we're hearing at this meeting. Right? So more data and more learning to come. Well, great. Thank you to the great panel. Thank you to Humanetics. And thank you all for joining us on your lunch hour, actually before lunch hour. Thank you very much. Thank you.

atrial fibrillation

ablation

advanced technologies

Vascade system

hemostasis

patient satisfaction

esophageal cooling

procedural efficiency

electrophysiology