Coast of China. Thank you, Dr. Jian. We will start actually with our second speaker, and we'll come back to our first speaker a little bit later. So we'll start with Dr. Eduardo Assad. Dr. Assad will talk to us about pericardial puncture for epicardial mapping and ablation procedure in a non-fluoro EP lab. Dr. Assad is working in Rio de Janeiro at this emergent hospital. Good afternoon, everyone. It's a pleasure to be here with you this afternoon. So we're gonna, we're gonna talk about a really challenging theme today. When I got this, I felt like that, and I decided to start my talk just for for full disclosure. I've been on a non-fluoro lab for the past six years, and I had decided to ask you guys, how many of you have done a pericardial puncture without fluoro? You can raise your hands. Have you? Three, four. Okay, great. I have not done one, so. So I'll try to to see how you did, then afterwards give you some time, talk to me. So let's go. So the traditional epicardial access in the EP lab for mapping and ablation was described in the early 90s by a Brazilian group with this sub-xiphoid approach, guided by fluoro and contrast injection in the pericardial space. Soon we realized how important it is to be precise in this access, and also that we have blind tract from the skin to the pericardial space, and we don't see the structures on fluoro. So whether you do an anterior approach or an inferior approach matters because of the, of the liver, and there was reported some cases of intrahepatic hematoma if you go through the liver or through the diaphragm. So you need to be sure you go above the diaphragm. So anterior accesses, such as the lateral view access, became more popular because of that. But that also carries the risk of hitting an artery or a coronary vein, especially the the lima artery that runs just behind the sternum. This is a significant issue. This is a, it's not published data, but it's personal data shared with people that really does a high volume of epicardial punctures, showing that it's expected that at least 10% of punctures have an RV puncture associated with that, although 50% of those are dry. But, you know, some of these patients need surgery, and, and also other issues of epicardial vein and intra-abdominal bleeding have been reported. So solutions to this problem are deeply needed, and this is one of them. Using a micropuncture needle to decrease the damage that you do become, became a little bit more popular, but then not as much because of the the handling of the needle. The needle is too soft. Some people don't like that for, for the epicardial access. And lately, it has become very popular to inject CO2 to increase the space between the parietal and the visceral pericardium. So this is an example that we've done. You see, all using fluoro, with a wire penetrating, perforating a small CS branch vein, and with that, we can actually inject CO2 in the pericardial space, increasing this distance between the visceral and the parietal pericardium. So when we, we are ready for access, we have this extra amount of CO2 in between those layers, and then, and this is the puncture. So it's, it's a beautiful technique that has been proven actually in a recent publication to be safer than a traditional access. So decreasing not only major complications, but decreasing significant bleeding. So this is something that to keep in mind if you want to do something fluoro-less. We need something to separate the, the visceral and the parietal pericardium. Even more recently, the Cleveland Clinic Group, Pasquale Sant'Angeli, published this technique. I think it's very elegant because it, it, it perforates the, the right atrial appendage with a very tiny wire and small catheter exactly to, to insufflate CO2 in the pericardial space, taking advantage of this pericardial recess here. So with that, he could actually show nicely in this publication that with intracardiac echo, you were able to see the, you know, exactly the, the spot that needed to be to be very precise in this puncture to go and access the pericardium. So I like really much this, this commentary published in 2020, which, you know, Paul's eye here was part of it. They're saying fluoro-less catheter ablation is a change that's inevitable. I really believe that and I think that the last frontier we have is really, you know, translating that into, into more complex procedures such as epicardial access and manipulation. However, when I tried to search on PubMed, I felt less bad that I didn't have a case to show you when I say, well, search for zero fluoroepicardial puncture and there's none, none, not a publication, not a single publication on that. When it's due with a zero fluoro VT ablation, there's one recent publication showing the feasibility and safety of fluoro-less VT ablation, but then when you're going to check the excluded patients requiring epicardial access and, and coronary angiography with that, which is a shame because this is a proof of concept. You see that in this specific study, 94% of endocardial VT ablation were successfully completed fluoro-less and the results are pretty good with a, with a, not, not more complications or less effective than has been published for, for fluoro use. So let's say, well, how can we develop a strategy to do a non-fluoro epicardial access? So I, I think for non-fluoro in this scenario means ultrasound. We need ultrasound and we can, we can use intracardiac echo and we can use surface ultrasound. And I, what I try to do is I try to, to bring the experience that interventionists, these echocardiographers and even cardiac surgeons have from pericardial synthesis procedures using convex transduce, transducers, and maybe the combination of those two modes of echocardiography can help us. That's something that I'm going to propose. So, eyes can be used to that advantage because it's easy to manipulate that inside the chambers and, and we can see the right atrial appendage, as I've shown before, and also there is a good view. If you, if you put the eye scatter on the RV, then, I'm sorry, it's, it's, in the RV, then we can, we can see both the RV and the LV, as shown in this picture. So this is an RV view of the LV. And here we can see the posterior wall and, and the papillary muscles, but also then the mid-epicardial dissipation have, and also the tip of, of the apex of the right ventricle. So these structures can be really well seen with eyes. But I couldn't, I could never see really well enough in the plane that I can see the needle going in nicely and safely. So this is a, this is something that I found from a Brazilian physician, actually on X. He showed that on this pericardial puncture that he does, he has done on an ARVD patient with an enlarged RV, almost on the home view of the eyes. We could see the guide wire, not only, it's not going inside the RV, but if you see that as he advances the wire, you see that he pushes the, the, the layer, the pericardial layers in there. So maybe this tells you that the wires in the pericardial space, but it's not good enough. So I don't think I can rely only on that kind of picture to say, well, it's from now on, we're not going to use fluoro anymore because we don't see the wire. So I have this case where I could really tell I have two sheets and I double punctured the pericardial space and I had two sheets in the pericardial space that you can see that they are there. But honestly, the, the, the main point is not this. The main point is how can I see from skin to pericardial space and then make sure the wires in the pericardial space. After that, we can do the fluoro. I think it's fine. So I think that we can learn from surface echo and this is something that I've been thinking about. So it's very common for pericardial, pericardial synthesis to be done from an anterior approach and not a sub-xiphoid approach because you can see really well the needle in plane. So if you do longitudinal puncture of the convex transducer, you can see the needle in plane. So of course this has a pericardial effusion here, it's easier, but you can see the needle, you know, perfectly pointing. So this is a, this is a case that I've done an ultrasound image from the anterior aspect of the thorax and you can see really well this is a patient with pericardial effusion here, anterior pericardial effusion, and this is the liver. So if I can put a needle on this tract here and, and watch it as it goes, I am not only sure that I'm above the liver, but I can, I can really see it going inside the pericardial space. So this is, this is why I think it's feasible. So on anterior pericardial axis, the main advantage will be a very short path from skin to pericardial space and, and we can be sure that we have it above the liver level, so to avoid the liver. And as I said, the needle visualization in plane would be a main advantage because then this, this part of the procedure is no longer blind. And that could potentially avoid the need for fluoro, although it would not avoid the potential complications of the lima puncture and, and a possibility of pneumothorax if you, if you run into the, the pleural space. So my take is that how could I imagine doing a non-fluoro pericardial puncture? So we can combine ice and surface, ice going first. So if you want to just puncture the right atrial appendage, as Pasquale told us, you can see that on ice. And then you cannot inject CO2 because air is very bad for ultrasound, but we can inject saline in the pericardial space, just creating a pericardial effusion, and then combine that with the surface echo to do that axis in plane. So this, this will be an elegant procedure that we, we could, we could do it very precisely and with no blind parts of it. Just combining ice at the beginning, injecting saline, seeing that pericardial space fills up, and then get a needle from the surface and, and get into the pericardial, thus mimicking what people do with pericardial synthesis. One thing is that we need to, there could be an issue is because we, to manipulate the catheter in the pericardial space from the anterior aspect will be different than from the sub-xiphoid one. But I don't think with, with deflectible sheets now, I don't think it will be a huge problem. And we just get, it's a matter of getting used to it. So I will conclude my time saying that non-fluoro pericardial axis is challenging due to the dry pericardial space and appropriate visualization of the needle and the advancing guide wire. Currently, there are no published experience of non-fluoro axis for ablation. But I think it's possible to visualize the needle in plane using the surface echo. And then there is a potential for the combination of that with ice to allow for safe and precise non-fluoroscopic axis mimicking what is currently done with pericardial synthesis techniques. Thank you so much for your attention. Thank you so much, Dr. Saad. We will be taking questions after each presenters. So if you have any questions, please come up to the mic. I would have a question for you to start with. I think it, I think it is very challenging actually to get rid of fluoro for epi, not only for epi axis, but for the epi procedure, the whole epi procedure. And do you have, do you usually do coronary angiogram prior to burning on the epicardial side? And that, if yes, then that's another issue with fluoro. Absolutely. Well, I use coronary angiogram selectively depending on where, you know, we have to ablate. Especially if it's near the valve annulus or, you know, near, you know, the left main area LVOT, then certainly I would. And that will finish up the non-fluoro part of it. But there's, you know, for instance, if you are in the inferior wall or more apical, I wouldn't necessarily do coronary angiogram. But then that would complete a totally non-fluoro procedure. But I agree with you. If you need coronary angiogram, that's a whole different story. Just a minute. Just to push it a little bit forward, let's say we want to have an angiogram, but we don't want to use fluoro. How confident would you be using a kind of ADAS or in heart model to integrate with your 3D and rely on these anatomical landmarks in order to assess the coronaries? That's a great question. I don't think I have a precise answer. I can give you, you know, my experience that I have using those systems. So far, what I've seen is that they are actually pretty precise. So, but I can tell you that in the real world, if I'm near, you know, a major coronary artery, like the left main or near the LAD, I would not rely on that. I would just go ahead and shoot an angiogram. Thank you. Please. Hello, my name is Chris Kowalewski from Nuremberg. And we were just wondering what patient this could be useful, kind of if you weight the risks of going on fluoro and then the advantages. I was wondering what potential use case there could be because I feel like, especially in VT patients, radiation is not that problematic because it doesn't significantly reduce their prospective survival. Yeah, thank you for your question. I think I understand what you're saying. But the idea behind being fluoroless is not being less precise. It's actually trying to compensate for a part of the fluoroless, I mean, of the fluoroprocedure that is actually we can't see anything. So when you punch yourself xiphoid, from when you enter the skin until you enter the pericardial space, you don't know where you are. So this is the main issue with that. Unless, the question is, can we make it safer? Can we make sure that we are above the diaphragm? Can we make sure that we see the needle the whole time and it has a perfect track that was the pericardial space? So can we, you know, make the pericardial space safer for allowing the needle to come in? So it's not a matter of just saving us maybe a couple of minutes of fluoro, which I agree with you, that's not a big deal. It's just a matter of saying, well, first of all, is it doable? And second, can we be more precise than we are with fluoro? And talking about that, I really think that we are more precise in some fluoroless procedures endocardially. So if we combine eyes and electronical mapping, you can be really very precise, let's say, mapping the right-left junction, mapping, you know, really with the eyes. I think when you force yourself to become fluoroless, you can see things in a much better fashion. So that would be the point, trying to make it even better, more precise and maybe safer than we currently have. Thank you very much. Thank you. I will now introduce the second speaker, Dr. Eliane Medea-Lopez from MSC Dominican Republic, who will talk to us about how to prevent and manage complication from a non-fluoro EP lab. Hello. Good afternoon, everyone. It's a pleasure to be here with all of you, talking about a topic that I'm very passionate about. There's so many benefits to be in a non-fluoro lab. And there's also risks associated with that. So let's talk about it. What are my objectives? To discuss the strategies to prevent and manage the complication in a non-fluoroscopic lab. And we all know that there's technology available. In the last decade, all the tools that we have in electrophysiology have grown exponentially. So that's allowed us to do more procedure and to do it more precisely. We all know the benefit. Illumination or radiation exposure is good for us. It's good for the doctor. It's good for the staff. But it's also good for the patient too, especially in pregnancy and especially women in EP for our trainees and to be able to do procedures throughout the pregnancy. Reduces the orthopedic strain for the operators. We all know that we spend hours and hours in the EP lab. So to be able to not to carry that lead apron is actually a huge help for us. And we all know that there's data about comparable success and complication strains from non-fluoro to the conventional procedure. What are the complications in the EP lab? The main ones, vascular complications, arrhythmia recurrence, perhaps because of not complete lesions, pericardial tamponade and catheter related issues. This is a real world data that I pulled this graphic from a combination of registry. The NCDR registry from atrial fibrillation ablation and the ARRA practice guideline and the SMART-AF trial. So the good news is that we're doing pretty good with specific in this part with AFib ablations. The complication rate is very low. We have vascular complications, only 2%, cardiac tamponade 1%, stroke 0.5% and everything is lower than that. So with a current practice, this is real world data, we're doing pretty good. So what are the benefits of this? And when all this started? It started in 2002. And actually it was Cogger from the Pediatric Radiation Ablation Registry that he started to study this. How much time do we spend doing fluoro procedures? And as we advanced throughout the decade, we noticed that we were doing the procedures faster and with less radiation. And it was not until later that Drago and his group did a study, only 21 patients, a pediatric patient with SBT, that he was able to do a complete study without fluoroscopy. So that was all started, all the excitement. The ACC released a recommendation that we all cath lab and all interventional labs, they should adopt the ALARA, as low as reasonable radiation for our cath lab. So this is when all the companies started to do the tools that we need, the eyes, the 3D mapping system, in order for us to advance. These are the first studies. All of them, as you know, they were initially, they were non-randomized, they were retrospectives, but later on, we have some randomized that their results were comparable. How we can prevent. I agree with Dr. Saad. When we're talking about non-fluoro, we need to have some sort of eyes, right? So my eyes is the intracardiac echo is the eyes, right? So electron anatomic mapping system are a must. Contact force catheters are very useful in order to know how much force you're applying to the tissue, and standardized protocol and team training. Your team has to be on board with you in order to minimize radiation in your lab. So how we started. So safe vascular access is important to have a direct visualization. We have the linear probe that are usually attached to the same echo machine. So it's very easy for you to access the vascular. We all know that we are all different. Sometimes we have overlap between the artery and the vein, and we can actually prevent complication just watching the needle go through and minimize time and minimize damage to the groin. And these are the vascular complications that I show you in the real world data, our complications, the 2% of that were vascular complications. And we put a lot of catheters for our patients in the groin area. So we want to avoid fistula. We want to avoid pseudoaneurysm. And all of that could be achieved with a simple ultrasound for groin access. And after you put your short sheath in the groin, we can access to the heart just by using our mapping system. The way that we do it is number one, you have to zoom out. Number two, the inferior vena cava, if you deflect the catheter anteriorly, you don't have branches. So you can easily go and deflect anteriorly so you can avoid all the obstruction from the branches in the vena cava, and just go through and you can watch it as you go through. Just look at your signals. As soon as you enter the heart, you will see signals. And use the eyes is available. I love eyes. I'm usually mainly also for left-sided procedures. Sometimes for the right-sided procedure, depends of the case, but it's very useful. This is our best friend in a non-fluorolab. You can actually see, we start in the home view. The home view is just putting the eyes catheter in the right atrium. And then as you clockwise posteriorly, you can actually see the whole structure on the left atrium. So this is the way we do our workflow. So you put the wire, you have your view in the superior vena cava, so you can actually see your wire as you move it. This is all without fluoro. So this is our wire right here. And then you advance the sheath, and then you can exchange your catheters. And this is very nice. You can do a cardosome map and you can fusion, and you can have a very nice correlation between anatomy. And for the transeptal puncture, this is the safe way. We all know that not all left atriums are created equal. Everyone has difference in shape, forms or thickness. So it is very important just to watch and you see how your catheter go through. This is, you can see how much pressure you're putting in and making sure that you have a good puncture to access the veins. This is a case that for the patients that are in sinus rhythm so we do an angio-CT to a sclerotrombi the day prior. So in this case, we just find out that the patient right in the intraceptal, our intraceptal axis, he had a diverticulum. So this is what's good to know prior because with ICE, we were able to look at it. We put our wire, advance our sheath, and this is the superior vena cava. And then we look at the diverticulum, and it was right here. So we were able to avoid it just by looking into ICE. So that's the way you prevent complications. And the other important part is that prevent damage, right? We don't want to harm our patients and we want to do procedures safely. I like to monitor the temperature of the esophagus. I think that is safe in some patients. Skinny patients, tiny little ladies, I like to monitor that. So you can do that floorless. You can actually see how the probe and you can move it and you can actually see how to move in the esophagus and the posterior wall to the left atrium. So another important thing, as I mentioned earlier, was your 3D mapping system. You have to use all the resources. You have your mapping system, look at the voltage, look at the activation maps, understand the anatomy, understand the substrate, and you can have better contact. This is flutters actually could be easy or you could have a very long and rocky surface. So to be able to map well and to see how much pressure using contact force catheters is a huge help. And eyes also is helping you for the lesion side, the lesion creation. You can see how much edema you create and this allows you to prevent complications. Another approach is the retrograde approach. Sometimes we just have to go to the non-coronary sinus. Sometimes we have to go to the ventricle retrograde. So you can do it without FLIR too. I like to zoom out, of course. Use a contact force catheter so you know how much pressure you put it in, especially in the aorta. You map the aorta as you go up anatomically and when you go into the valve, you just make a tight curve right up in the ascending aorta and then you prolapse. You can guide, I usually use eyes for all of this so I can actually know where I am and correlate anatomically. So again, your mapping system, I use all the resources, voltage map, sinus activation map so you understand better the substrate and I like this correlation with cortisol map because it gives you a better understanding of the 3D anatomy, especially for those complex papillary muscle, arrhythmias, VTs and more. So we all know that we can actually, in this view, let me just mention. So this is actually similar to what Dr. Satz mentioned, the eyes actually is located in the RV so you can actually see better the left ventricle and here, you can have a very nice correlation, anatomy and eyes so once you get familiar with this, you can do it completely without fluoro. What are the main complications? Pericardial tamponade is very rare. We talk about less than 1% nowadays with the tools that we have but having eyes helps you to have a better visualization, understand a little bit the lesion side, how much heat are you putting in and again, if you see a prompt pericardiocentesis, vascular complications, I think that this could be avoided completely by using ultrasound. You can actually see and again, it's not a sign of weakness that you use ultrasound, it's a sign that you're smart and you care because every patient have anatomically differences. You can have overlap, you can have different anatomy so use it, it's right there and it's not costly and arrhythmia recurrence, again, you can actually look at the lesion side and this is, we all have arrhythmia recurrence, especially those difficult flutters that are very resistant so this is, you know, you can do the whole case, again, the same principle using your eyes for guidance and you can actually look at the lesion side, use very detailed mapping with multipolar catheter so you can actually see a very nice mapping and look at your lesions with eyes. This is an example of a case of a patient with non-ischemic cardiomyopathy. This case is a BT that we access epicardially. I did a little bit of fluoro for the access in this one, actually, I still do fluoro, I feel more comfortable and again, this is not to promote that it's bad to use radiation, I think that the priority is the patient, is that you feel more comfortable and safe to do it some way, just do it the way it is, however, minimizing radiation is good for you, it's good for the patient, it's good for staff so for this access, I use the fluoro, however, the rest of the procedure was fluoro-less so you can actually see here where the arrow is, is the tip of the catheter, this patient has a big scar here and after the ablation and the image F, you can actually see the edema created in the pericardial space, which was very nice and again, we have better tools to map, we have better tools to touch the tissue without harming the tissue and that's important and again, using all the resources in order to understand your patient, understand the substrate, what is the underlying pathology, I love for this ventricular arrhythmias using my MRIs when you can understand a little bit where the scar is located and again, you use that and correlate it with your images, this is our eyes images again from the RV view, give you a better view of the LV and this is the scar and it correlate perfectly with a scar in a non-ischemic cardiomyopathy patient and this is our patient that we induced the ABT and it was a case fully done without radiation. So what is our workflow? Again, patient assessment, you have to make sure who is your patient, what are the comorbidities, anesthesia planning, you have to think about it, what are the requirements if you need general anesthesia or you can do conscious sedation, vascular access, what is your plan, one groin, two groins, you're gonna use ultrasound and again, imaging and mapping plus eyes is a plus for this pluralized procedures and the ablation technique. For this ones, I love to use my contact force catheters, you have more feedback, zero or minimal fluoroscopy, again, depends on the patient, prioritizing safety for you and your staff and post-procedure care. So in conclusion, non-fluoroscopic EPLAB procedures are safe and effective, proper protocols and techniques are essential and again, ongoing training is crucial and I wanna point out, this is a huge benefit, this is me, I was pregnant with my second baby and this is, I was able to do all the pregnancy due cases because I have a non-fluorolab so that was good for my staff. You can see that none of us has lead and we were able to do in my home country and introduce this for the first time in 2020. We actually, being from Latin America, you know that cost is important and eyes could be costly so we did this case series and we validate cost effectiveness of all of our cases and we published that actually, we can reuse that, we develop a protocol that we can re-stabilize them and do it safely and so if you guys wanna, we published our protocol in ERA in 2023. Thank you so much. Thank you, is there any questions from the audience? We can take time for a quick question. You can't, yes, we can take time for a quick question. Oh, the microphone is over there. I came to learn tips and tricks. Patients when they have a lot of traffic in the atria, atrial lead, ventricular lead, another abandoned lead, CS lead, at the left bundle atrial facing lead, what is your approach? That could be challenging. However, ICE provides you a very nice view so even when the patient have leads on it, you can actually see if you're anterior or posterior to the lead so you can see very nicely. I have done ablations multiple times with pacemaker leads and you can actually see it. Even for the CTI, sometimes you see that lead there. Again, it is safe, it's doable but there's patients and patients, there's patients that have five leads and abandoned leads so whenever you feel uncomfortable and then you feel that you cannot see well and again, that's when you stop the non-fluoroless and you can see it, exactly. But yes, but it's doable in most of the cases. Thank you very much, Dr. Lopez, for this nice presentation. All right, thank you, everybody, and thank you to the chairs for the invitation to speak on this really, I think, interesting session for me. It's something I'm also very passionate about and have spent many years of my career advocating for this kind of a thing, and my topic is a report of the non-floral registry in the U.S. That's the topic I was given. I modified it slightly and more because we have some, I think, interesting and relevant data for this session that I hope you will also find interesting, my disclosures. So it goes without saying we understand specifically when it comes to AF and AF ablation, this is a global and growing problem. We also know that this is from the European guidelines looking at the trends of AF in the population, and we know that part of the, in the U.S. guidelines, in this pillar kind of a picture, a cartoon, that managing AF burden, typically through ablation nowadays, is a key part of our management of our AF patients. However, even with all of the new technologies we have available, including things like PFA, I think we have room for improvement. We, whether it's, these are just a sampling of recent studies, whether it's cryo, RF, or PFA, we still have room to improve our outcomes. This is the sort of background into developing these registries that I'm going to talk to you about, and then focusing specifically on the question of fluoroscopy elimination or minimization. So what I, the way we thought about this when we started these registries several years ago is that current ways of doing research, there are gaps in our knowledge generation. So if you start with probably the gold standard of large-scale randomized studies, they can ask one question, perhaps get an answer to that question, but they're, of course, cumbersome to enroll patients and follow. It's a very controlled patient population, so that it's, the generalizability of the results can be limited. You know, we have, of course, many large-scale registries, either government-funded or sometimes industry-funded. They often, as a result, lack some granularity. The data is often collected as a requirement, so it's seen as a cumbersome task, and again, because of the lack of granularity, there often can be a lack of ability to apply it to clinical practice. And then, of course, there are industry studies, and they have their own limitations as well. They're very product-specific. Minimal number of subjects are usually enrolled to just achieve statistical significance, and there can be bias because it is sponsored by a biased organization. So this missing gap here is what I'm talking about, and the questions we wanted to answer are how do interventions behave in a real-world practice, and how can we optimize little things that we do day-to-day to improve our procedure outcome, and how can we tailor those interventions to the specific patient, and, of course, always be on the lookout for some unexpected findings. So this is the idea of a real-world evidence systemic data collection kind of a model. And so the goal, then, is to reflect what we do in the real world day-to-day, evaluate granular procedural and clinical strategies otherwise that are hard to study with a traditional model, and to have the flexibility and scope to answer different questions beyond just one question. So this was started now seven years ago, the Real AF Registry. So the concept is that we founded, among a group of like-minded physicians, an interest in systematic continuous improvement of our AF ablation procedures, initially industry-sponsored, and with the criteria of enrollment high-volume operators, continual learning interest, practice patterns that match what we defined as a standard practice. And we started this off, actually, as a low-zero fluoroscopy registry. Now we've expanded that to be able to compare zero and low and medium-use fluoroscopy, I should say. By now, this year, we have almost 70 sites with over 100 investigators. We have over 8,000 patients now enrolled, with a goal of about 15,000 patients. And these are right now for this registry. And I'll get into some of the other things we're doing. It's a Biosense-sponsored RF paroxysmal and persistent day of registry where we're collecting all this data. And we use what's called a learning health network to try to improve our procedures. And this is where we're getting to the zero fluoroscopy idea. So just very quickly, this is how we collect the data. It's very standardized, based on what we considered standard, one-year follow-up approach for monitoring clinical follow-up and such. So shifting gears a little bit to get to the topic at hand of fluoroscopy reduction and fluoroscopy-free procedures, as was eloquently described, you know, we all should be abiding by the ALERA principle, as low as reasonably achievable when it comes to radiation exposure. And so we are really obliged to think of ways to achieve that, to minimize risk to both us and the patient. And on top of that, the issue is that using fluoroscopy for ablation has many limitations, as Dr. Saad also very eloquently described. You don't see everything that you think you're seeing. You know, for example, I use this example because, so if you do an AFE ablation using fluoroscopy, here's a mapping catheter, do you know for sure this is in the pulmonary vein? Well, I labeled this as pulmonary vein, but what on this image tells you it's in the pulmonary vein? Nothing, really. So it also lacks information. Now in terms of the potential harms, this is also a slide I show a lot because this patient is still memorable to me from several years ago, a patient that I received for a redo procedure five years after their first procedure. The operator for the first procedure used over 90 minutes of fluoro, which is a lot of course, but they resulted in a permanent skin injury in this patient. That's just a very stark example, but if you look at large scale data, this is modeled data in the oncology literature that you can significantly increase patient malignancy risk with fluoroscopy exposure based on amount of fluoroscopy exposure. So real problems. And of course, for us as well, as the operators and the staff, wearing lead is an issue, radiation risks are an issue, and there are plenty of anecdotal and survey literature that suggest potential risks involved in that, both for us and our colleagues in interventional cardiology. And as I already described eloquently, the keys to this are utilizing mapping system and ice, as I show here. We have some just as a plug, a shameless plug. We have a few textbooks that have sort of looked at both the idea of learning a little bit more about ice as well as learning about fluoroscopic reduction techniques. There is continued interest. So unlike Dr. Saad's PubMed search, mine, if you look at fluoroscopy free procedures, there's a continued growth in the literature. So getting to the data that we've generated. So with this registry, the idea here is that with zero fluoroscopy ablation, so how is fluoroscopy use impacting the outcomes? Can we compare different groups, whether it's zero, what we would define as low or standard fluoroscopy use? And we hypothesized through all of this that using minimal or zero fluoroscopy would allow us to still achieve equivalent safety and efficacy. So this is cumulative data. We presented this last year as a late-breaking trial at this meeting. So when you look at just paroxysmal atrial fibrillation patients, so almost 80 operators and high-volume operators overall, we reported nearly 2,500 patients one-year outcome data. This is their baseline characteristics. And you can see, as an answer to one of the questions here, a number of them have implanted devices. When you look at the results here, just highlighting and focusing on the fluoroscopy use question, so not only do we, well, I'll show you the clinical outcomes, but in terms of the fluoroscopy use, in our registry of, again, nearly 2,500 cases, nearly 3 quarters of those patients had their procedures performed without fluoroscopy. Most of them achieved first-pass isolation using a high-power, short-duration approach. We used this ventilation protocol that we've published on to minimize catheter movement. And again, the high level of zero fluoroscopy use. And even in those who used fluoroscopy, the mean fluoroscopy time was under two minutes. And even with that, if you look at the outcomes at one year, this is what we presented. 81.6% freedom from all atrial arrhythmias using a zero fluoroscopy approach in most of these patients, with very low complication rates, under 2%. Now, this is another plug. This is one of our fellows. Andreas is presenting our results on persistent AF ablation through the registry. So just a quick preview of that. You can see here as a highlight, one-year outcomes comparing zero versus non-zero fluoroscopy ablation outcomes for persistent AF, both very much equivalent in about 75%, 76% freedom from AF range at one year. And zero fluoroscopy use, a little bit lower in this population, a little under 60%. But again, even in those who did use fluoroscopy, mean fluoroscopy time is 1.18 minutes. All right, so this was already shown earlier in a presentation. But just to go into that and more part of the presentation, we have looked at things beyond AF ablation with RF. So as already shown earlier, so I'm not going to spend too much time on it, but our group has looked at outcomes with zero fluoroscopy VT ablation. And to highlight the results here at our single institution results, about half the patients were mixed between ischemic versus non-ischemic, with a VT-free survival rate approaching 80%, complication rate 3%, all primarily without fluoroscopy. So very feasible, very much doable in experienced centers. Similarly, we move beyond RF ablation. So we have just begun and have very quickly gathered quite a large cohort already looking at pulse field ablation. So we've started a registry now we've called Disrupt AF, which is another similar type of registry, but specifically looking at the Boston Scientific Ferripulse device. Just again, another plug, we have a poster coming up later in this meeting. I'm not going to give the full results, but you can see that zero fluoroscopy, even in a wire-based Ferripulse PFA system, is used in a reasonable amount of patients. And you'll see the growth pattern of that as well. Now, one other sort of highlight I want to mention as well in the last couple of minutes is a little bit of a different study. So if you all are familiar with the ADMIRE study, which is the IDE that Biosense ran and published looking at their variable loop circular PFA catheter. So the ADMIRE study showed, as you probably know, good long-term freedom from AF results. So we took that data and did a sub-analysis comparing those who did the procedure with PFA using zero fluoroscopy, using what we'd consider intermediate or low fluoroscopy use under five minutes, and those who use what we call conventional fluoroscopy, which is above five minutes. And we looked at the question of whether or not there are differences in outcomes. And we presented this at APHRS last year, and the manuscript is currently under review. But if you look here at the one-year survival curves, they are pretty much overlapping between conventional low and zero fluoroscopy use, all hovering around that same 74% or so, plus or minus, freedom from AF at one year with the VariPulse device. To highlight some of the detailed information, there's still, in this study, a preponderance of conventional fluoroscopy use. But you can see here, zero and low fluoro still account for quite a significant portion of these patients in that study. And safety, this is not statistically significant. But interestingly, there's a trend towards actually lower complication rates among the zero and low fluoro use compared to the conventional fluoro, which I think highlights the points made earlier that maybe we shouldn't be calling this fluoro elimination, but rather ice enhancement studies or ultrasound enhancements procedures, where you add this imaging modality that helps enhance the safety and perhaps efficacy of the procedure. So the last thing I want to mention is that then, with the registry data, with being able to study these kinds of zero fluoro kind of approaches, we were able to leverage that data to actually allow Biosense Webster to gain a FDA indication to use their system without fluoroscopy. So now you can say that you are performing an ablation without fluoroscopy with their system because it's an FDA indication. And so that's, I think, quite an interesting milestone. And then going beyond that, we've taken that registry data and, within the context of using minimal fluoroscopy, have tried to then further tweak, improve the procedure. And we've fortunately been able to then, as a result, look at various different questions that have helped improve procedural outcomes, primarily so far with RF. But as you see, we're moving beyond RF to PFA now. And just as maybe a sampling of what we're doing, you can see the evidence generation is steadily increasing year to year through our registries. So to summarize in conclusion, this registry called Real AF, as well as now Disrupt AF and others that are pending, are prospective multicenter registries that include high-volume centers and operators performing RF and PFA AF ablation. Zero fluoroscopy procedures we've demonstrated through these registries in the real world are both safe and effective, and possibly safer, I should say, thus emphasize the word possibly. Zero fluoro approaches are safe across, so far, the PFA platforms that we've studied, as I've shown you here. And adoption of zero fluoro and PFA in particular is lagging, of course, because it's a newer technology. But there is a learning curve and we expect with our ongoing studies that we'll see how this continues to improve over time. So I'd like to end my presentation here by acknowledging my collaborators, both at my local institution and through the registry as well. Thank you very much. Thank you very much, Dr. Zhe. In the interest of time, we'll move on to the next speaker and we'll take the questions for the two last talks at the end, if it's okay with you. Thank you. Let me introduce the last presenter from Sir Ron Ron Shaw Hospital School of Medicine, Zhejiang University, Dr. Jiang Ru Hong. His topic is non-fluoro ablation with IIS guidance. So, Dr. Jiang, please. Thank you. I'm sorry for late. It's my honor to share our experience about non-fluoro ablations. We use a fluoro ablation, for example. This is the experience from our hospital and China. This is my disclosure. So besides the risks from the x-ray just presented by Professor Paul, we have another problems. One problem is that it's a very rapid growth in the populations of a fluoro ablation in China and the procedures, the volume of procedure for every center is very huge. So this is the situations we work before. We work very late in the midnight. This floor is our lab. So every floor, they work home and we still work. And also, there are some occupational body pains for our physicians. For the advancement of the cancer therapies in China, now we can use non-fluoro procedures for most EP procedures. As a benefit of these strategies include, firstly, we can avoid the x-ray. The second, we can reduce the cumulative harms of the radiation, not just for the patient, but also for our physicians. And the third is, it can reduce the cost to buy the DSA machines. And then, it can help to reduce the scheduling conflicts with other interventional procedures. This is one sense we'll do the AFib ablation in our surgical operation rooms. There's no DSA. We use a 3D mapping systems. We use the eyes guidance, and it's very safe, and it's very convenient. This is our working platform for the non-fluoro AFib ablations. We use a 3D mapping systems, intracardial ultrasounds, and we recommend to use a contact force sensing ablation catheter. And for AFib ablations, this is our workforce. Firstly, we use the eyes to examine, is there any thromboids in the AOAA? Then we build the AOAA geometry, use ultrasound, also with multiple electrode like a lasso, like a pantry. And we do the transceptor punctures, guided by the eyes, and then we do the PVI. The following steps is not very difficult. And we use the eyes to monitor the complications all through the procedures. Now, firstly, we take maybe about six critical frames to build geometry of the left atriums. Like the home view, we build AOAA, and there's AOAA, and there's a series of atriums where we send the left PVs, and there's a location of the esophagus, and the right PVs, and like the ridge between the AOSPV and the left atrium appendage. And then we do the AOAA, and we do the transceptor punctures. Firstly, we get the SCV view, and we insert the lung vial, and then followed by the lung sheaths. And we pull back the sheaths to the site of punctures, and use our electrical knife just to give a 20-volt energy, and the vial will get into the left atrium. And then we put the vial to the left AOSPV, and followed with the lung sheaths. And the transceptor puncture is done. Then we use a lasso of pancreatic catheters to build a PV geometries, and these two geometries with a fusion technology and to build a whole AOAA anatomy. And then we use a brace catheter to do the PVI or other strategies like linear abrasion. And we use the eyes to guide the abrasion. For example, when we go to the AOSPV, we can see that the abrasion catheter is very, very precisely at the outtermost of the PV. And also, when we do the ridge abrasion, you can see the ridge is in the side of PV or in the side of the AOAA. Also, when come to the PFAH, we also can see the situation about the contact between the catheter and the tissue. This is a ferropath abrasion. And we monitor the complications that include the thrombosis, which can be increased during the procedure. And we also monitor the pericardial tamponade also the procedure. And we have several years, we come to non-fluoro procedures. Firstly, between 2009 to 2020, we do the non-fluoro EP procedures in the traditional DSA room. And we can perform non-fluoro in most cases. And in 2022, we tried the procedures in the surgical rooms, which totally without the DSA equipment. And in the last year, we have our own non-fluoro EP room. This is just nearby our traditional DSA room. We can see this is very, very clean. And we use a bigger screen to see the 3D mapping systems and the eyes images. And for now, we do more than 100 procedures in our own non-fluoro EP room. And we also based our Chinese HIs. We train the physicians and we help the hospitals to establish a non-fluoro EP lab. And we give them the certifications. And to ensure this technology is safe, our team, together with other hospitals, we published the expert consensus on the construction of the fluoroscopic EP lab and related technologies. And now there are more and more non-fluoro EP labs in China. For this year, about 80 total non-fluoro EP labs was established in China. And just before I leave, we will start the first case in the EP lab, in the non-fluoro EP lab in our new campus. That's my presentation. And welcome to CHIS 2025, which is next month in China. Thank you. Thank you, Dr. Jiang. Because time limitation, we have one question for Dr. Cai. So, yeah. So when do you, will be competent to do the procedure without lead apron? Yeah, this is, I think, a really good and important question. I always use the analogy, it's like training wheels on your bicycle, if you teach your kids how to ride a bicycle. So, meaning that you gain confidence little by little. So maybe you wear lead for all of your cases at first when you're embarking on this journey. And as you learn each step that you realize, oh, I did this whole part of the procedure without needing to step on lead. Then you eventually realize you've done most of the procedure without lead, you can take it off. I think the key point, I think most folks in their learning curve encounter is being confident in doing the transeptal puncture without lead. And so many people will wear their lead until they've safely accessed the left atrium, then take off the lead, re-scrub, and then finish the left atrial procedure. So at least a good transition point. So just like your kids riding a bike, you take the training wheels off and hold the back of their bicycle, and eventually they don't realize you let go and you're doing it. I think I had a question for the whole panel. So our last speaker just mentioned using ice to rule out left atrial appendage thrombus. I'd be interested in what views and then what the rest of the panel does. Do you select certain patients? Do you always do another imaging study? What's your protocol there? Good question. So the question is when we use ice to detect thrombosis in the ALA. Yeah, not routinely we did this strategies for all of the patients before operation. We didn't do the TEE for the patient because the TEE is not very comfortable for the patients. And we also can compare with TEE and ice with TEE. And actually there is a significant low incidence of the left appendage thrombus in the ice group. And also we need to examine the angle, the fence in several positions. First in the right atriums and go to the IVOT fence. And sometimes we go to the pulmonary arteries to see the different directions. And from the published papers like action ice one, action ice two studies, it's also okay when we only use the TEE, we only use the ice catheter. Thank you. Thank you, and if I may add, I think it's not only a question of imaging but a question also of anticoagulating properly the patients prior to the procedure. So I'm much more confident to rule out thrombus using ice if the patient was properly anticoagulated prior to the procedure. So it's now time to close the session. I would like to thank my co-chair, Dr. Chen-Yan Jiang from China. I forgot to present myself in the beginning. I'm sorry, I'm Isabelle Knott from Canada. I would like to thank all of our great speakers and that shared with us their experience in building this new way of performing ablation and navigating through our EP procedures. And thank all of you for joining us at this joint Chinese and HRS session. Wishing you a great meeting going forward. Thank you so much.

non-fluoroscopic techniques

electrophysiology

ablation procedures

pericardial puncture

epicardial mapping

radiation reduction

intracardiac echo

3D mapping systems

zero-fluoro techniques

pulse field ablation