My name is Andres Miranda, I'm one of the Cardiocardiology fellows at the Brigham, and it's my pleasure to present this abstract, which is No Drain, No Pain, a stepwise approach to avoid post-procedural epicardial drain in patients undergoing epicardial access. Let's start with a little bit of, I don't have any conflict of interest here today, and then why is this important? Well, as you know, epicardial access for AP procedures has been widely used these days, and it's not only used for therapeutic purposes as it used to be before, now we use epicardial access for ventricular tachycardia ablation, hybrid atrial fibrillation ablation, also some challenging central tachycardias may need epicardial access, also for LAA occlusion procedures specifically with the Lariat device, and also for some challenging accessory pathways, and then of course for therapeutic purposes. But you know, why do we leave drains in people after epicardial access? The full rationale for that is because people bleeds, and then what's the risk of bleeding in different epicardial access series? We have that it may go from 2.6% and may be as high as 7.7%, 8.3%, and almost 9% with different techniques and different approaches. And then even with more advanced and sophisticated approaches such as CO2 insufflation, you may see that patients are now free of bleeding, and then almost 5% of people may develop a degree of bleeding here. So when you are deciding to leave a drainage after epicardial access, you have to balance between the pros and cons, and definitely the pros are going to be effusion management, but then the cons are there and are important to keep in mind, specifically pain and irritation. You may remember if you have seen patients with epicardial drainages in place, how painful and uncomfortable they are. Of course there is risk of pericarditis, mechanical pericarditis, nursing care, you know, you need to take care of your drains, and also infection risk. And then I've seen a couple of purulent pericarditis associated to this in the past. And then so let's go back to the pro, it's effusion management, but it's effusion management if it develops. And then so if you are careful enough, and then to avoid that, you may be able to avoid your drain. So I wrote this paper here from 2018 saying that the major focus on improving safety and epicardial access should be reducing unintentional cardiac puncture. And that's important, and please keep that in mind for later. So this is the series of publications that we've been working on at the Brigham for the last year. This is the SAFER approach, which is sustained apnea for epicardial access with right ventriculography. And it's interesting to see how in different HRS meetings we've been publishing a little bit of this. So this was published in 2023 in New Orleans, it came out. The technique is basically apnea at the end of expiration. You do an RV gram, and then you do another RV gram during inspiration. And then a manual compression of the abdomen during access just to minimize the risk of ulnar viscera perforation. And then the RV gram with power injector, as I said before. And then with those approaches, the results of the technique in 2022 were 100% epicardial access success, 0% of RV perforation, which is our focus today, 0% of surgical interventions, 0% of major breathing. And then time to apnea time was two minutes. Time to epicardial access was approximately seven minutes in that trial. Last year I presented in the HRS also the efficacy and risk of complications associated with epicardial access in people with uninterrupted anticoagulation. And then we published that as a research letter showing that performing these procedures in people under uninterrupted anticoagulation did not increase the chances of complications. And then as a third part of this series of publications, our last publication was about intrapericardial corticosteroids and colchicine to prevent pericarditis after epicardial access. And you may see here how this intervention also reduced the risk of pericarditis and the risk of new onset HR fibrillation. So the aim of our study was basically that, demonstrate that it was possible to avoid post procedural drain in patients undergoing epicardial access for ectophysiology procedures using the safer epicardial access technique. So what are the methods? It's a multicenter prospective study, consecutive patients coming for epicardial access for different EP procedures undergone from 2021 to November 2024. All of them were performed using the safer epicardial approach. And then drain was removed at the end of the procedure. And the primary outcome was incidence of procedure-associated complication. That's the primary outcome for this. And then this is just to summarize the line of interventions that we did. Everything is started at the pre-procedural optimization. Patients are admitted usually 24 hours before for optimization of antiarrhythmics, watch out of antiarrhythmics, monitoring, pre-procedure imaging review. We use in-heart music CT scans. So we usually review a scar. We assess also distances from a skin to the heart for epicardial access. We also optimize anticoagulation management. And then we proceed with the day of the procedure. We do access using the safer approach. You see, I mentioned before the steps. And then finally, during the procedure wrap-up stage, what we do is we do interpericardial steroids for every patient after the procedure. We do 200 milligrams of tramsinolone with a 20 milliliters flush. And then what we do is before removing the agility wire, the agility sheath that is in the epicardial space, we advance a wire, a Benson wire specifically, and we'll leave it there for 15 minutes. We remove the sheath, we leave the wire in place, and then for 15 minutes under ice, we just are monitoring for pericardial effusion accumulation. And then if during 15 minutes there is not any accumulation of fluid, we remove the wire and then the case is done. During the post-procedure time, usually patients are admitted for at least 24 hours. And the result in 24 hours, basically we do inpatient surveillance, we monitor for any signs of effusion. We start cultusing very early after the procedure, ideally in the first six hours. And then we do a TTE before discharge, 24 hours after the procedure, again, looking for fluid reaccumulation. What are the results? So these are some of the characteristics of the population, 159 people total, age 65, most of them male, 65 percent, BMI, I mean, 31. You see here how most of them have a history of a structural heart disease, 85.5 percent, and the ejection fraction on average is 44 percent. Successful epicardial access was 100 percent, procedure time was 237 minutes, fluoroscopy time, 8 minutes, time to achieve epicardial access, 7 minutes, similar to the first trial that we published. And the mean hospital stay was 2.1 days with an outlier patient who stayed admitted for a while. That's why you see this average here. So complications rate, which is our primary outcome, you see here 3.1 percent, cardiac tamponade, 0.6 percent, bleeding more than 80 milliliters, 0.6 percent, is a coronary artery laceration that required this. And then mild precardial effusion, 0.6 percent, hypotension during the cannulation on the groin, 0.6 percent, and one case of groin hematoma, 0.6 percent as well. But most importantly, and the reason why this is possible, there was not any incidental RV puncture during this cohort. So for discussion, and to keep this in mind, post-procedural epicardial drain can be avoided after epicardial access if you adopt a stepwise approach, including a pre-procedure, inter-procedure, and post-procedural interventions. Also, if you avoid RV perforation, that is the most important step of this. If you avoid that, you can reliably say, I don't need a drain, because you're not going to have effusion. And then all these show us that complications remain low, and there's no increased risk of cardiac tamponade. Two limitations, I mean, this is an observational cohort design. All interventions were carried out in high-volume centers. All procedures were performed using the SAFER approach, so we're not using or assessing any other different technique here. This is only validated for SAFER, and this is the conclusion. The omission of post-procedural epicardial drain is possible when a standardized protocol is followed, and the approach enhances patient's comfort and reduces risk of drain-associated complications. No more than that, and thank you all for listening, and have a good day. Thanks a lot. Okay, so hang on for a second. We've got two minutes for questions, if anybody has any. Just real quick from my standpoint, it looks like you have to use full lateral x-ray for that, so you have to have a system that's good enough to get around that way. And do you do this with the patients under general anesthetic? So they're under a GA when you're doing it. And you said you do that breath hold. How long does it take, then, to advance the needle under that breath hold? What's the period of time for just that access? Thank you, Dr. Stearns. All great questions. So we do the procedures under GA. The breath hold is usually an average two minutes. We advance the needle through the skin. It's a two-way needle, long needle, and then we advance the needle in fluoroscopy. We use biplane AP and left lateral, so that's what we use most of the times. And when you're nearby the heart silhouette, what we do is we ask the anesthesiologist for apnea, and then we go access average time on this cohort study, on the first trial, I mean, we're at 2.2 minutes. And you have also to tell the anesthesiologist that they're going to take care of that time because we forget about it. You get access and you start mapping, and then you start listening to some beeps, and the anesthesiologist kind of ventilates, please do. Any other questions? Okay. Thanks very much. All right. All right. We'll move on to the next one. It's my honor to introduce Professor Jose Luis Moreno, who is the former president of the European Heart Rhythm Association, who's going to talk about relationship of atrioesophageal fistula with the use of esophageal temperature monitoring probes, esophageal visual techniques, and types of sedation results from the global Potter AF study. So, ladies and gentlemen, it's a real pleasure to be here. So my task is to discuss with you the results of this registry, and let's start with some background. We know that several strategies have been proposed to prevent atresophageal fistula in effibrillation. However, their protective or potentially harmful effects remain uncertain, including the role of sedation and general anesthesia. In fact, there are some previous small but randomized trials suggesting that general anesthesia results in increases of esophageal temperature and esophageal damage. This is complex because we have to acknowledge that there is a high heterogeneity in the use of sedation. Certain countries like in U.S., this country, most FE procedures are performed under general anesthesia. This is different in others like Europe, or certain European countries, and Japan, in which deep sedation is mostly used, or others like China, that the conscious sedation is the preferred sedation. So the objective of this study was to evaluate the incidence of atresophageal fistula in relation to three things. Number one, esophageal temperature monitoring probes, esophageal visceralation techniques, and type of sedation. To evaluate this, we took data from the POTER-EF registry, that was a multinational registry, collecting data from esophageal fistulas worldwide. In addition, a survey was done at the time of the registry, so not only data from this fistula patient were obtained, but also from the population, from which these patients came from. So information regarding the thermal monitoring of the esophageal probes were obtained, visceralization of the esophagus, and type of sedation. So here you can see the results of this registry that were presented to the ERA Congress and simultaneously published in the European Art Journal, and as you see, out of over half a million procedures from more than 200 centers, roughly 140 fistulas were identified. So from this patient population, what we performed is that we found that we collected all information from the centers reporting esophageal fistulas, and 20 of them needed to be excluded because data were incomplete. With this, we ended with this subset population, in which mostly patients were ablated with RF, some of them with cryo, and very few with other techniques. Here you can see the centers participating, and we are grateful to all of them. And now the results. In terms of esophageal temperature monitoring, we found when the probes were used, the likelihood of having an esophageal fistula was significantly decreased. Still the p-value, considering the data from where it's coming from, is somewhat marginal. In terms of the use of visualization techniques of the esophagus, again, when these techniques were used, there were more fistulas when they were not used. We can discuss why this was. Here you see in a more graphical or visual way the results. Esophageal monitoring resulted in less fistula, and esophageal visualization was linked to more fistulas. What about the type of sedation? Here you see that there were differences. Most procedures were done under general anesthesia, and they resulted in 31 fistulas with this incidence, compared to the incidence that was found with conscious sedation was significantly larger. We performed head-to-head comparison, but it's better that you see them in a graphical way. Here you see the comparison of conscious sedation versus deep sedation and general anesthesia. So significant differences, and when the patients were grouped in sedation versus general anesthesia, there were still differences, but what was more different is when conscious sedation was separated from deep sedation and general anesthesia. So the difference is quite striking. Of course, there are limitations to this data. Number one, there is retrospective data from our registry, so it may happen that the incidence is a little bit underestimated. This potential selection bias, because we were using just data from center-reporting atro-saphaeal fistula, and we know that this may have led to an overestimation, but we also included in the general registry centers without atro-saphaeal fistulas. Finally, the other limitation is that the current data are coming from centers which reported atro-saphaeal fistulas, and this analysis may be biased because maybe we should have taken the general data set. However, this also may introduce new biases, like for example, centers not reported fistula may have approached the procedure in a less aggressive manner, with less power, and with different types of sedation. So to sum up, number one, the use of esophageal temperature probes was associated with a significant lower incidence of atro-saphaeal fistula, while esophageal visceral resuscitation showed a paradoxical increase in risk. Number two, deep sedation or general anesthesia appears to be safer than conscious sedation, and these findings need to be confirmed in the entire poter-efib population. Thank you for attention. Thank you very much. Any questions from anybody? Again, if you want to ask a question, you have to come up and use this mic. I'll just start by saying, so why do you think that the visualization increased the risk? Do you think it was giving people a false sense of security or something, or what's your thought? Yeah. It's a good question. In fact, it's something that we were not expecting. We were expecting just the opposite, and we have no explanation. One potential reason is what you properly pointed out, maybe it's a false feel of safety. These cases came mostly from data of not high power short duration, where people, by reducing power, may have had a false sense of safety. There are several potential explanations. Then just another one. I know there's not a denominator on this because it was only certain centers, but I noticed that about 60% or something like that used RF and the rest cryo, just based on that graph. What is the split from the centers using RF and cryo? Is it a lot more cryo than RF, so the cryo still has a markedly lower risk of it, or is that similar to what the split of the use of RF and cryo is? The chart that I showed represented the general population of centers reporting fistulas. Most procedures were performed with RF. But there's a fistula that has been already published in the main paper. There were very few coming from cryo. Most fistulas came from RF, one from laser balloon operation. Thank you very much. I will try to move this at the same time to the next talk. The next speaker is Daniela Incapi-Tabarez from Brigham and Women's Hospital. The talk is Safety Profile Using Pulsed Field Ablation, Prospective Multicenter Disrupt AF Study. Good afternoon, everyone. My name is Daniela Incapi, and I'm thrilled to present our work titled Safety of Pulsed Field Ablation in a Prospective Multicenter Disrupt AF Study. So a little bit of background. So pulsed field ablation is an emerging technology that delivers ultra-short bursts of ablative energy with electrified field energy. So there are scarce systemic studies of the safety of atrial fibrillation ablation using PFA real-world data in the U.S. So the objective of our study was to evaluate the safety profile of patients who underwent atrial fibrillation ablation using the pentaspline PFA caterer from Boston Scientific in a multicenter prospective registry. So let's get into the methods. So the disrupt AF study is a non-randomized observational prospective multicenter study, delivering real-world data from patients undergoing atrial fibrillation ablation via the pulsed field ablation using the pentaspline caterer from Boston Scientific for the treatment of atrial fibrillation following a standard of care clinical practices. So let's get a little bit deep down in the methods. So we are aiming to include 2,000 participants in three different groups. One is the acute group, where we're only going to collect patients' data in the baseline and index procedure data. The symptomatic monitoring-only arm, including follow-ups at baseline, index procedure, three months, and 12-month follow-up. And the full monitoring arm, including additional asymptomatic arrhythmia recurrence at six and 12-months follow-up. So the inclusion criteria are patients' candidates for AFib ablation, a schedule for ablation with the pulsed field ablation system from Boston Scientific. It should be at the novel procedure, or we can include redo procedures if the index procedure is already included in the registry. And the patient should be at least 18 years old. As for exclusion criteria, if the patient is enrolled in any investigational drug or device trial, if they have had undergone a previous left atrial ablation, or if they have currently anotropic or mechanical support. Also if they have any known contradications for the pulsed field ablation or catheter ablation, they will not be included, of course. So as for the procedural approach, the ablation procedure is going to be done, it was done using the Boston Scientific Parapulse Pulsed Field Ablation System for the treatment of atrial fibrillation. Pulmonary vein isolation was performed per standard of care, and any additional ablation lesion sets were performed as per operator's discretion. So the follow-up, as I said before, it was depending on the arms of the study. So it could be done baseline, index procedure, three months and 12 months, or six months in the full monitoring arm. And the data includes procedural workflow, clinical outcomes, procedure or device-related complications, and otolaryngal recurrence. So we evaluated 1,076 patients from 20 currently active sites with 177 operators. The safety of the pulsed field ablation treatment was based on reported procedure-related serious adverse events within the database. So let's get into the results. So we can see that we don't have any significant difference between the baseline characteristics from the patients who reported serious adverse events with the ones who didn't report. However, in the procedural characteristics, we can see that there was no difference in fluoroscopy or procedural time, but in the scar area, the patients who reported serious adverse events had a greater scar area percentage, without a statistically significant difference. So of the 1,076 patients, only 18 patients reported procedure-related serious adverse events, representing 1.7% of our sample size. The complications were pretty fine and immediately reported per protocol. So let's break down all the serious adverse events that we saw in our registry. So as you may expect, vascular complications were the vast majority, including hematoma, AV fistula, and pseudodermatism. Also it's important to highlight that we collected information of two deaths in the registry. However, they were deemed not procedure-related. One of the patients died 28 days post-ablation because of hypotension after sotal load loading that resulted in acute kidney injury and death. And the other one, the other death was reported 120 days after the ablation procedure, but the cause of death wasn't reported to the site. So as our discussion, we want to discuss all the previous safety outcomes that has been published of all catheter ablation, including PFA, cryo, and radiofrequency ablation. So of course, the pulse field ablation, our conventional thermal ablation from Dr. Reddy, the ADVENT trial. So they show complications rates with pulse field ablation of 2.1% in a small sample size of 305 patients, and thermal ablation encompassing cryo ablation and radiofrequency ablation with a complication rate of 1.5% in 302 patients. Also we have the safety from the MANIFEST-17K study with robust results of more than 17,000 patients showing that the greatest vascular complications were 2.2%, and their PFA energy-specific adverse events were phrenic paralysis, coronary spasm, and hemolysis-related. We can see in the results also that with the physician learning curve, the complication rates improve also with time. So now we wanted to compare real-world data from the Euphoria Registry from the European Centers with our data. So we can see here that the results are consistent, showing a complication rate of 1.7% as well, which is really similar to our registry. Also last year, we published a late-breaker trial from the real-world data of paroxysmal atrial fibrillation ablation, showing a complication rate for paroxysmal atrial fibrillation ablation of 1.9% with a sample size of 2,470 patients, and this manuscript will be submitted soon, so you will see it shortly. It's the data from the persistent cohort from the VLAF registry encompassing 1,900 patients where we saw a 2.1% complication rate. Later on, these are even more robust data from a meta-analysis conducted by Dr. Benali, which included more than 15,000 patients of atrial fibrillation, including radiofrequency ablation and cryoablation, where they show an overall complication rate of 4.5% and a severe complication rate of 2.4%. So to conclude for our study, the complications rates were similar and very low across AFib classifications. As you remember, there were no statistically difference between patients with paroxysmal or non-paroxysmal atrial fibrillation. The vascular access-related complications were the most common, which is consistent with previously published data. There were no esophageal injuries. We only had a few events of coronary spasms, only two patients in the registry, one with paroxysmal atrial fibrillation and the other one with non-paroxysmal, and there were no significant difference observed in baseline characteristics, including age, BMI, fluoroscopy time, and procedural time. So we report a 1.7% complication rate, which is a low rate in a real-world registry, and it's even a lower rate compared with the previously published data that I recently showed you. So there's a table comparing or, for your easier review, discussing all the trials that have actually displayed the safety outcomes of pulse fibrillation, cryo-ablation, and terminal ablation. And we can see here that real-world registries are showing real-world data, and non-randomized registries can actually provide safety-like confirmation of these techniques. So I would like to thank Dr. Elizabeth Wong for her major contributions to this project. Also thank you all the Disrupt AF investigators, and a special thanks to my mentor, Dr. Paul Tsai. And thank you to the Cardiac Arrhythmia Service for everything. And thank you so much, everyone, for listening. Thank you. Any questions? Nobody wants to come up to the mic? Okay. Real quickly, again, most of these being vascular issues, do you know if ultrasound was used routinely for access? Did they use closure devices, anything like that? So usually in the—every practice is per standard of care, and it's center-related, like center-individualized, but most of the centers, approximately 80% of the operators, they use ultrasound-guided femoral access, and also they use proglyper close and those kind of devices to closure. There were—I mean, again, now we're finding out, you know, before or since this started, the biochemical issues. Was anything like that looked at in this registry? Is there any more data coming out from that? So not yet, but in the future, great idea. Also I wanted to highlight the hemolysis complications. It's important that we didn't have any hemolysis complications in the registry. So the mean of IV fluids that they are using in the procedure are approximately 1,000 ml. So it's not like a standard of care, like a pre-procedural IV fluid, like acute kidney injury protective protocol, but the mean is 1,000, and we didn't experience any hemolysis. So probably these protection protocols, renal protection protocols, are worth pursuing. Okay, so you didn't look specifically for hemolysis, but it wasn't bad enough to be clinically relevant? We looked for hemolysis, but we didn't evidence any hemolysis in the registry. Okay, okay, all right. Great, thank you very much. Okay. All right, so next up is Dr. Wirk Hosma—I'm sorry, I slaughtered that—from Amsterdam, talking about evaluation of severe adverse events in relation to radiotherapy dose in stereotactic arrhythmia radiotherapy. Thank you for watching. Great. Thank you. Thank you for the kind introduction. My name is Wiethoek Sman. I'm a Ph.D. candidate from the Amsterdam University Medical Center in Amsterdam, the Netherlands. And on behalf of the cardiac radio ablation study groups from Lausanne, Switzerland, and Amsterdam, the Netherlands, I'd like to present our study entitled Evaluation of Severe Adverse Events in Relation to Radiotherapy Dose after Stereotactic Arrhythmia Radiotherapy for Ventricular Tachycardia. And I have nothing to disclose. Some backgrounds. Stereotactic arrhythmia radiotherapy, or STAR, or cardiac radio ablation, is a promising and emerging bailout treatment for patients with otherwise therapy refractory VT, and that is patients with VT recurrences despite optimal, frequently high doses of antiarrhythmic drug treatment. And after one or more conventional invasive catheter ablations, our patients are unfit or unsuitable for catheter ablation. And these patients are usually treated with a very high dose of radiotherapy in a single fraction, a single fraction of usually 20 to 25 gray, which is delivered precisely to the proarrhythmic VT substrate. And in prospective single arm studies, it's associated with a marked VT burden reduction. Regarding safety now, in these prospective studies, they usually report short-term toxicity that is within 90 days, and overall follow-up in these studies is usually not much longer than one year. Although from radiation oncology literature, we know that severe adverse events can occur way longer, way longer after treatment. And besides, from radiation oncology, there is a lack of data in this high, patients with this high dose prescribed to the heart, because the heart was traditionally considered an organ at risk, and organ at risk, that is meaning the dose exposure should be minimized, the heart should be avoided in radiotherapy treatment plans. And from preliminary star for VT data, we know that severe adverse events can occur as these reports, for instance, illustrate regarding a gastropericardial or a cervical pericardial fistula. Therefore, our aim was to evaluate middle-term toxicity after star for VT and relate this to the prescribed radiotherapy dose to abdominal or thoracic organ at risks or to cardiac substructures. Now, this was a bi-centric two-platform study performed in Lausanne, Switzerland, and Amsterdam, the Netherlands, and patients were treated with star for a therapy refractory VT, either within a prospective trial or based on compassionate use. Patients were treated with 20 to 25 gray in a single fraction to the prorythmic VT substrate, either on the CyberKnife, which is a robotic-guided step-and-shoot treatment platform, or the Agility, which is a volumetric-modulated architherapy treatment platform. Follow-up consisted of regular follow-up, according to local protocol or study protocol, and adverse events were scored according to the common terminology criteria of adverse events, the CTCAE, which is commonly used in radiation oncology and cancer literature. And cardiac substructures or abdominal and thoracic organ at risks that were not delineated as part of clinical workflow were retrospectively delineated, and mean and max point dose were calculated using velocity software and reported for the possibly, probably, and definitely treatment-related severe adverse events. And in these patients with severe adverse events, the prescribed radiotherapy dose to the patients with severe adverse events is compared to the patients without the severe adverse events. And looking at the results, between 2017 and 2022, 27 consecutive patients were treated with star for VT and included in this study, and resulting in a median follow-up of 36 months. And the follow-up was caused by, for eight patients because they died during follow-up, two patients underwent heart transplant, and the exposed cardiac substructures were, well, transplanted, so not part of study follow-up anymore, and two patients underwent redo star. Looking at the patient characteristics, median age at star was 67 years old. Most of the patients were male. Roughly half of them had an ischemic cardiomyopathy, other half had a non-ischemic cardiomyopathy, and median ejection fraction at baseline was 45%. Now, as can be appreciated from the radiotherapy details, there are substantial differences between the two treatment platforms regarding clinical target volume, that is, the target volume is delineated by the cardiac electrophysiologist, and the planning target volume, that is, the finalized treatment plan, finalized by the radiation oncologist, taking cardiorespiratory motion and surrounding organ at risk into account. Now, looking at the adverse events, during a median follow-up of 36 months, seven treatment-related severe adverse events were observed, and they're listed in this table. To quickly go through them, one patient developed a rapid progression of aortic valve stenosis, leading to percutaneous aortic valve intervention. One patient suffered from congolmonary hemorrhages, hemorrhage one from severe chest wall pain and one from cardiac chest wall pain, and most frequently observed adverse events was the severe pericardial effusion, and the prescribed radiotherapy dose to these patients was significantly higher in patients with severe pericardial effusion compared to patients without pericardial effusion, although it is important to acknowledge that we used the radiation oncologist and CTCAE criteria for adverse events, and they name pericardial effusion a severe adverse event from the moment we perform an intervention or there are physiological consequences, and these patients develop pericardial effusion gradually. They stay asymptomatic and do not have physiological consequences. To illustrate this, this is one of our Amsterdam cases. This is pre-therapy CT scan. This is the start treatment plan. The red line indicates the treatment area that has been treated with a radiotherapy dose higher than 25 gray, and this is the two-year-later CT scan. This can be appreciated. There's a large amount of pericardial effusion. This patient was completely asymptomatic. There were no physiological consequences, so it's developed gradually, and ultimately, we did perform pericardial synthesis on this patient. So to conclude, in this bi-centric two-platform study in Lausanne and Amsterdam, we observed seven severe treatment-related adverse events during a medium follow-up of 36 months. Only for severe pericardial effusion, the prescribed radiotherapy dose was significantly higher compared to patients without severe pericardial effusion, and some discussion points. Although for cardiac radioablation studies, this was a relatively large cohort with extended follow-up, this is obviously still a small patient cohort with a relatively small follow-up, short follow-up, taking into account that radiation oncology adverse events usually take longer to develop, to occur. And a collection of this data of adverse events was limited by the partially retrospective nature of this study and by the CTC terminology, as it is not entirely appropriate probably for the cardiac adverse events. Thereby, I'd like to conclude and thank the entire research group from Lausanne and Amsterdam for this collaboration. Thank you for your attention, and I'd be happy to take any questions. Very nice, thank you. Sorry, we didn't have a microphone high enough for you. But any questions out there? Congratulations, first. Second is, one of the issues with the radiotherapies is mitral regurgitation. So you have any exploration, or you have any clue if any of your patients developed a higher degree of mitral regurgitation? Thank you for that question. This is a very interesting question indeed, and I think you're referring to the Chaco public paper, which serves a significant amount of mitral regurgitation and no, we haven't looked into that yet. In the Amsterdam cohort, in the Swiss cohort, I know they have observed one mitral regurgitation case, but the prescribed radiotherapy dose to the mitral valve was not significantly higher compared to the patients without mitral regurgitation. However, I think there indeed is enough rationality to study this in a larger cohort, probably into a European or American cohort with a lot of patients, because it is, I think, conceivable that the complex valve, the mitral valve, is vulnerable to these high doses of radiotherapy. Thanks for this excellent talk, Dr. Hoeksema. You saw, you know, pericardial effusions being the most common. In left-sided breast cancer, the rate of pericardial effusions after radiation is about 10 to 15 percent. We saw pericardial effusion as our most common side effect in the ANCOR VT trial. Is it time for us to just empirically treat people with colchicine before we do this? What is your thought about that? Thank you, Dr. Kukulic. That's an interesting suggestion indeed. We're actually doing that right now in our STAR-NL number two trial. I do not have any data on that yet, because, as you see, it takes some time to develop, so we need some longer-term follow-up data. But I think, yes, possibly it wouldn't harm that much, although some patients experience some gastrointestinal side effects, of course, but you can stop it. So I think, yeah, that would be a start, yeah. But again, so this is asymptomatic without physiological consequences, and these are patients with therapy refractory VT, so I think, yeah, exactly checks and balances. Great. Yeah, thank you. A very sick group of patients. An EF of 45% and 10 out of 38 or whatever are gone within three years. So, yeah, you know, the long-term with them is maybe different than the long-term for somebody where you're looking for a cure. But any other questions? No, that's great. Thank you very much. Thank you. Was there a question? Oh, yeah, sorry. Yeah, come on up. We actually, we have a couple minutes, so we're okay. Terrific job. Thank you very much. I have a question about your AS patient. So, one, where were you treating? So what was the substrate, and what was the time course of that AS progression? So, interesting question. One of our Swiss patients, and I have to look up the targets, it was in the area of the aortic, I'm sorry, it was in the area of the aortic valve. Although, so it was quite rapidly as within, I think, 1.3, let me go back to the slide, 1.3 years, as you can see. So it was quite fast, yeah. Just kind of related to that is you talk about dose relationship, but was there a difference in location relationship for the complications, like septal versus free wall, things like that? Yeah, I think this has probably a lot to do with each other. Although, yeah, you, I think you could say that the target sort of relates with the underlying etiology, underlying etiology of the cardiomyopathy, and thereby has consequences for the valve as well. Yeah, I think that's something we have to study in larger groups as well. All right, fantastic. Thank you very much. Okay, and we'll just move on to the last one. I'll try to do this simultaneously. Okay, so our last speaker is Dr. Ken Kawase from the National Cerebral and Cardiovascular Center in Japan presenting comparison of complications between laser balloon and cryo balloon or radio frequency ablation in an analysis using the J-ROAD DPC database. Hello everyone. My name is Ken Kawase in Japan, National Cellular and Cardiovascular Center. The title is Comparison of Complications between Razor Balloon and Cry or Radio Frequency Abrasion Analysis Using the J-Rod DPC Database. Here is disclosure of this study. The Razor Balloon is a diffractable balloon-shaped device designed to enable pulmonary vein isolation with direct visualization as a recto-atrial pulmonary vein junction. Once the target location and the direct contact with the tissue are confirmed using an endoscope and a system called arc generator, the 918 nanometer laser energy is applied to the designated site. In a randomized control trial, comparing Razor Balloon and Radio Frequency Abrasion for pulchicis maloatrial fibrillation, the safety and efficacy of Razor Balloon Abrasion were non-inferior to Radio Frequency Abrasion. Razor Balloon Abrasion demonstrated similar efficacy and safety to Radio Frequency Abrasion for persistent AF. Compared to Cry Balloon Abrasion, some studies have reported similar periprocedural safety of Razor Balloon Abrasion, although these findings are based on small patient populations. So the periprocedural safety of Razor Balloon Abrasion has not been reported in large populations within a real-world setting. In this study, we aim to clarify the periprocedural safety of Razor Balloon Abrasion for AF, compared to Cry Balloon or Radio Frequency Abrasion using the Nationwide Database. JL Road DPC is an administrative database that covers over 800 hospitals in Japan, and most of them are Japanese Circulation Society certified training hospital. It concludes the following information for each patient. The DPC database contains six categories of diagnosis, sorry, based on the ICD-10 course, each with a limited number of recordable diseases. The outcomes were in hospital death, complications occurred during hospitalizations, and within 30-day readmission. A complication is here. And two separate logistic regression models were fitted to estimate the propensity scores for undergoing Razor Balloon versus Radio Frequency Abrasion and Razor Balloon versus Cry Abrasion, respectively. One-to-one propensity score matching was performed for each comparison based on the estimated scores. We identified 213,744 hospitalizations with cartilage abrasions for AF between April 2018 and March 2022. Then we excluded these patients. In total, 179,207 patients were included in this study. Razor Balloon groups had 3,000 patients, had 3,193 patients, all of whom were included in one-to-one propensity score matching. And consequently, both comparisons had 3,193 patients in each group. After matching, the covariates were well-balanced. This slide shows baseline characteristics of the original cohorts. The number of Razor Balloon was low, only 1.8% of all AF abrasions. Median age was 68 years. The percentage of paroxysmal AF was higher in Razor Balloon abrasion than other group. And this was shown in hospital outcomes of the original cohorts. 101 patients, 3.2% of Razor Balloon experienced periprocedural complications. The incidence rate of stroke, or TIA, was 1.6%. The incidence rate of cardiac tamponade was 0.5%, which was comparable to that reported in previous studies. The incidence rate of frictional palsy in the Razor Balloon was 0.1%, which was relatively smaller than that in previous report. It is possible that only severe or persistent cases were captured through the diagnostic coding. In hospital, mortality and readmission within 30 days were low. And these figures show in hospital outcomes of the PSMATCH cohorts. Razor Balloon was associated with higher incidence of combined complications compared with ratio frequency, whereas no significant difference was observed between Razor Balloon and Cryo Balloon. Razor Balloon was associated with higher incidence of stroke, or TIA, compared to ratio frequency or Cryo Balloon aberration. In hospital, mortality and emergency readmission and other complication rates did not differ according to the aberration system. In hospital, mortality and emergency readmission and other complication rates did not differ. And this shows stroke incidence of the previous report in the Razor Balloon. The stroke occurs in 1.6% of patient in this study. This incidence was comparable to that of previous reports, which ranged from 0% to 9.1%. The mechanism underlying the occurrence of stroke after the Razor Balloon is not fully understood. However, Razor energy deployment adjacent to the blood can theoretically increase the risk of some coagulation with subsequent stroke embolism. The Razor Balloon, similar to the Cryo Balloon, is a device with a deflectable balloon structure, which may predispose to air embolism due to air trapped around the balloon. Further studies are required to elucidate these underlying mechanisms. We recognize some limitations. The study design was observational and retrospective, and the treatment was not randomized. We are only able to identify complications during hospitalization. Therefore, the study did not include long-term complications such as pulmonary vein stenosis. Pulse field ablation was not available in Japan during the study period. Therefore, we were unable to conduct a comparative study. In summary, this study includes the largest number of patients who underwent ablation with Razor Balloon. Razor Balloon ablation was associated with a higher incidence of a stroke than that with either Razor Frequency or Cryo Ablation. Also, no significant association was observed between in-hospital mortality or other complications. Finally, I'd like to thank my co-authors and mentors for their support. Thank you for listening. Thank you. Nice. Thank you. Okay, anybody have any questions? Okay. Yeah, you did, as you said, the balloon is a balloon. Is it structurally that different from a cryo balloon that would cause it to create more coagulant, or do you think it's more likely it's that heating effect from the laser that causes the problem? Thank you. That's a very important question. But in this study, my database is not fully included in the operator or institution's data, and maybe Razor Balloon is some coagulant solution, but balloon embolism is not different or cryo balloon or Razor Balloon, I think, so. The heating effect may be involved. I'm the co-author of this abstract, and I would like to support him. So I think that, I believe that thermal effect is more important, because the air embolism rate known in cryo balloon abrasions is pretty low. So even though the structure of the balloon is pretty similar with the cryo balloon, I personally think that thermal effect is more important. Yeah. Thank you so much. All right. Okay, well then, thank you very much, and thank you, everybody. I think the band is gonna start up in about two minutes, so thanks.

cardiology

electrophysiology

epicardial access

pulsed field ablation

stereotactic arrhythmia radiotherapy

ventricular tachycardia

atrial fibrillation

safety measures

cardiac procedures