You will see a change to the schedule as everybody has flights to catch or buses to make. So, we will also skip the introductory lecture. We'll dive right into the topic. And we have the honour of having Pedran Kazemian with us. And without further ado, go right ahead. I appreciate it. Thanks, everybody, for persisting through the day at the last minute. So, I was tasked with talking about remote telerobotic EP procedures, benefit and barriers to broad access. So, historically, you know, the remote procedures started in 2001 by, you know, Dr. Jacques Markov, who did the cholecystectomy from New York, was done in France in Strasbourg. But very shortly after that and very aptly at the 2006 HRS meeting, you know, Dr. Paponi did an AFib ablation remotely from Boston back then, which HRS was in Milan. So, this, we're going about now 2019 years ago. So, this is not a new field. And we were proud to be one of the very first groups that actually did remote ablation robotically. Now, when we talk about robotic ablation, it means different things to different people. And for this talk, I will include all of them. So, you will see telerobotic surgery, which means that somebody remotely navigates the catheter, for example, performs ablation. We have telepresence, which means that somebody remotely is seeing the procedure but can also interfere or do some procedures remotely. And then we have telementoring, which I'll get back to later, which does not involve doing the procedure remotely but is involved in the procedures, sees all the lesion and maps. So, what are the benefits of telerobotic surgery? And I'll try to allude to that. Despite lack of broad evidence for all of this, I do my best. So, long-term cost effectiveness in terms of reduced hospitalization, reusable devices, increased flexibility, improved access, enhanced diagnostic capabilities, such as real-time echo, improved procedural success rate, reduced travel time and cost, and patient satisfaction. So, in the world that we live right now, there is a significant limitation in terms of access to EP procedures. So, this is data from 2023. And if you look at the 23 sub-Saharan countries, only five of them, they do EP procedure, and four of them only have electroanatomic mapping procedure. In South America, 49%, half of them, have access to electroanatomic mapping. And of those, 80% of procedures are only done in two countries, Argentina and Brazil. So, there's really no access there. Even in countries where the EP is growing, such as India, which used to have only four EP lab, there are now 400 of them. But keep in mind, the population of India is billions. So, if you think about the ratio of EP lab to the people, it's infinitesimally small. So, there is a definite need internationally for access to EPS. How about locally? So, this is a trial, a pilot trial. It was done in Washington in a small community where they tried to do a simulation ablation from Chicago using the Oculus and then some robots locally. And I'll come back to this study later. So, there's definite need for robotic, telerobotic procedures, which hopefully we can achieve, given the history that we have. How about cost effectiveness? Now, we don't have, obviously, a lot of procedures done telerobotically. So, the data is not there to collect this and find the cost effectiveness. So, I found something similar, at least close to what we have, to see if we can extrapolate from that to the EP procedure. This is cost-effective remote robotic mechanical thrombectomy in patients with acute ischemic stroke. And they used Markov modeling and cost-benefit analysis as a time horizon of a lifetime of the patient. And as you can see, the bottom quarter shows that this approach is not only cost-saving, it's actually the dominant. So, it's cost-saves and it's actually better. And overall, even if you include the top right quadrant, 89.8% it was cost-effective. So, there is data, albeit now not directly from EPS, that this is cost-effective in the long run. Travel time. Again, we don't have direct data for this, but this was a remote study actually was done in Germany, where they used remote for 50 patients. They used support remotely or locally. And they showed that by doing remote support, they reduced the travel time by 11,000 kilometers cumulatively within the 50 patients that they had. So, clearly, there is some cost-saving for the support staff and also for the patients. You can imagine if this is done for patients that need to travel long distance to reach the first available hospital. How about improved outcome? Again, we don't have direct data for the EP procedures, but this is a study that was done in Sweden. And they used robotic-assisted remote echocardiography. And that device that you see on top right is a robot that performs echocardiography. They installed it in a place, in a clinic in northern Sweden, which was not easily accessible. And by doing that, if you can see in the table below, they were able to reduce the days to procedure from a median of 30 days, sorry, a median of 86 days to 12 days. So, it improves access when we can provide this locally. How about education and training? So, this is a big part of the telerobotic. You can have experts that are remotely located. They don't have to travel. And we have procedures done at a distant place that can be supervised. And the trainees and even attendings be mentored remotely. And this is possible if we have telerobotic available. And the current system that we have, the serotaxis, has remote clinical and technical support, but has peer-to-peer training and proctoring. And remote EP mapping and ablation is possible. There is this new poster that was presented at EHR last year, which is interesting, where they did remote magnetic navigation for complex arrhythmia and congenital heart disease. This is an area that most of us who do adult EP don't necessarily have a lot of experience in. And there are very few experts in the world that do. We have Dr. Ernst here, obviously, but the likes of her are not found very easily. But when we have equipment like this available, you can schedule your patient, for example, and remotely can be mentored and followed up by an expert in the field. So in this case, for example, they mapped a phantom heart, and they showed that the phantom heart had no difference in terms of the time it takes to map compared to people who were locally present. And then when they did the actual case, they were able to successfully perform it without any complications remotely. So this is one of the few data actually we do have currently of the remote procedures. How about the barriers? So the barriers are many, regulatory, technical challenges, patient engagement, cultural factor, infrastructure, data management, and economic constraint. And I will allude to some of them quickly. So technological infrastructure. Obviously, we need a high-speed internet connection. And the Cardista, the study that I showed you with the Echo remote, they use a 20 megabytes per second connection with a maximum latency of 20 milliseconds to perform it. We have done remotes. In fact, last year during SCRN, we performed ablation from Washington, and the patient was actually in China, and we were able to perform that without any problem. So the current bandwidth and latency that we have is adequate for performing this. This can be mitigated further by satellite broadband connection, internet connection, which doesn't really require infrastructure implementation locally. And this would be probably applicable to sub-Saharan Africa and those countries. But then you have loss of network connection, and you have to – there are challenges in this study that I showed you in Washington. They actually incorporate that to this study. So without the knowledge of the operators, they disconnected the internet to see how they manage this, and they were able to manage the procedure without any problem with the local training. So network security is another issue. Again, that's probably not a major issue because we do all our banking using the internet, and they're pretty safe. Technological infrastructure – so the mobility is an important issue, and the new generation, Genesis X, I put there, is a semi-mobile. You can actually install it within 24, 48 hours. There's a model actually here on site here that was installed within 24 hours. And there are a lot of things coming down the pike that help us with improving this technological issue. There are visual feedback. I didn't type in the papers. There are lots of papers on high-resolution imaging, virtual interactive presence, floating autostereoscopic 3D display. We have stuff on the dedicated – sorry, wireless networking, which I mentioned some of them, and the haptic feedback. How about clinical challenges? So during the procedure, you may have complication. You may have a tamponade, and you may need to train some non-EBITS. In the study that I mentioned in Washington, actually one of the challenges they did was the cardiac perforation challenge. And what they did is that they gradually reduced the patient's blood pressure, increased the heart rate, simulating a tamponade. And the local surgeon who was there was able to perform a pericardial synthesis on the model. And that's how they trained them. So there are models for pericardial synthesis. You can see on the right side that the local surgeon or technician can train on and be facile with performing the procedure without having the actual electrophysiologist locally performing it. But at the end of the day, you need somebody locally to do it, but that person does not have to be necessarily an electrophysiologist. How about education and training? Again, I won't go through details of this, but there is a lot of work that needs to be done. Again, I won't go through details of this, but remote operators have to be trained on robotic and also telerobotic. And that needs credentialing. As SCRN, we hope to be able to achieve this. We have lots of fellows who are, through the training that they go for their fellowship, they get exposed to robotics. And by the time they graduate, they will be trained both in the robotic and hopefully telerobotic. Now, economic, there is an upfront cost, obviously. So, you need to buy these devices, and many of these third world countries or even advanced countries with low neighborhood, with low income, they may not be afforded. Well, there are two possibilities. One is that the price is gradually going to come down over time. As I mentioned, there is a long-term cost savings, so that may pay back for itself. And also, we have the mobile units with miniaturization of these magnets. Maybe you can go to these local neighborhoods and perform the procedure and come back, and the local neighborhoods don't have to pay for the initial purchase. Regulatory is areas out of my hand, but issues regarding data privacy, security, liability. Who is liable? Is this local physician liable, or is this person who actually performed the procedure liable? How do you manage the insurances with regards to liability? This is something that needs to be sorted out. And also, cost. So, as you know, most of the robotics-assisted devices are under 510K processing, but if you start including autonomy and other things, it may be requiring pre-market approval, which, as you know, the time to get the approval and also the cost of getting approval will be astronomic at that time. So that's, again, something that we have to talk to the people involved in the regulations, and hopefully that will be solved. Sociocultural. You know, patients may feel anxious. Somebody performing operation on them remotely, they never saw. But that's something that we can educate them, say, well, this person that does the procedure is actually way more experienced than I am, and they've done this, and this is to your benefit. And that can be overcome by education. Patient engagement initiative, cultural adaptation of telemedicine, and those sort of things, and that can be solved. And AI. I feel a big need for incorporation of AI to telerobotic. As I put the picture here, this is what we have for autonomous driving, which you need some sort of the sensors, and you need maps, and incorporation of that to navigation. Well, cardiac robotic navigation is no different. We have sensors, many of them available. We have lots of road maps from the form of ice, and CTs, and MRIs, and electron atomic map. And the AI would be the junction where they bring this thing together, and we can help with navigating the catheter. And I think that's, as we move forward, if you move from sort of this robot-assisted or level one autonomy to level two, the task autonomy, conditional autonomy, many of these issues will be solved. If you lose, for example, connection, and the device is able to complete the task without the need of continuous supervision, then the continuous communication is not even necessary. You can start the task and continue with the procedure. So I think these things will be solved, hopefully, very soon, because we're at an interesting juncture of time where these barriers and benefits seem to be insurmountable. But some of the technologies we have, like AI, increased connectivity, the robotic technology is improving, and the societal norms are changing as people are now comfortable with driving autonomous taxis and those sort of things. We can easily overcome this. So in summary, telerobotic EB procedures evolve over our lifetime. Key benefits improve access, reduce patient travel, is comparable or superior to procedural outcome to the manual local presence, opportunities for remote training and proctoring, which you cannot get in other ways. There are some barriers technologically, clinically, financially, and socioculturally, which are improving. But future direction hinges on integration of automation, AI policy, infrastructure, global collaboration, and engagement of professional other societies like SCRN, which we are glad to let you know that we have our next meeting, actually, in Scottsdale this year in October. So for those who are interested, please go to the website and sign up and join us. Thank you. Yeah, that was a terrific talk, very comprehensive, and thank you very much. We're going to be holding questions until the end in order to keep moving along. We also appreciate that we've seen actually some of our staff letting people know about the SRN meeting as well with the postcards. So everybody is, of course, invited. We'll go next, actually, to Dr. Sabine Ernst speaking about the ARM approach, robotic facilitation of upper extremity access-based procedures in electrophysiology. Thank you. Thanks, Pete, Katja, dear colleagues. My voice is slightly gone already, but I hope you can hear me still very well. And I also have to escape relatively quickly after this, so I hope that if you have a question, just shoot it right away. So I'm going to talk to you about the ARM approach. ARM stands for alternative access remote magnetic navigation. Why is ARM a cool thing? It eliminates bed rest as simple as it is. It's an invasive procedure, and you can use it, and it's very elegant to use it with magnetic navigation. You probably could do it also conventionally, but I've never tried, besides positioning just the diagnostic catheters. And there's a clear benefit of the patient convenience, and I think that's actually a very good argument. Why are we doing what we're doing in conventional EP? We do it because it sets a straight line up. We go transeptal to get into the left atrium for our procedures. But many procedures are done, of course, on the right side. But you could go the other way into the left atrium. And in congenital heart disease, I've done this for all the years that I'm using magnetic navigation. We've always not done the transbuffer puncture. We've always done a retrograde approach. As you steer only the tip of the catheter, it's very, very simple, and it works. And I've done it in hundreds of patients. So the idea was to say, okay, if we need to go left, why don't we do it from a brachial? Or, in fact, I want to show you that radial is probably even a step more elegant, and better, and safer to do for patients. Now, let me go forward and say the very reason why we're all here together is that Werner Forstmann did the first cardiac intervention by putting a urinary catheter from his cubital vein in his arm into his heart, and then walked over to x-ray and did this in 1929. That's nearly a hundred years ago, and we're coming back to this in a way. Radial angiography is about 30 years ago. PCI, and nowadays it's a standard of care. It's shown to be safer, more convenient for patients. There have been tools adapted to this approach, and by now, at least in Europe, it's over 90% of all coronary interventions. So there's no reason why we in EP are still so far behind. People are a little bit concerned that the vessels would not be large enough, and we have done a study in our center. Just basically, every volunteer, everyone who works in the cath lab, was scanned with ultrasound, and we just measured how big the vessels are, and you can see in this nomogram here for the left arm and the right arm that in all of the volunteers, there were 63 healthy volunteers, at least one vessel was large enough to have an eight-friend sheath, and that's what we need for an ablation catheter, at least at the very moment. If you go a bit further, you can see that you can bring even bigger sheaths in those vessels, and you typically have a basilic vein, you have two brachial veins, and you have a cephalic vein, and then you have, of course, a brachial artery. We didn't measure at this point the radial arteries, but the interventional colleagues put typically a five or six fringe, but they upgraded sometimes to 10 fringe, so we need to kind of learn from them on how to do this good and safely. I did a case report a couple of years ago about two cases, both one congenital and one with blocked femoral axis, and that was how that was triggered and how that we started this. You can see here the angiogram of the basilic right arm vein, and that was a patient with a fronton palliation and basically no, absent inferior cavernous vein, and we had to come from above. I would have traditionally done this with a jugular or subclavian approach, but I just simply moved a step further out, avoiding the risk for pneumothorax, so that worked really brilliantly, and the second case was a left-sided pathway in a young patient who had so many femoral interventions that there was no access anymore from below. How do we do this? We do this with ultrasound-guided punctures. As every central lumen catheter is positioned in intensive care, we just simply do it not on the neck, but on the arm. I think, again, I think there's a seismic shift even in normal EP to do vascular access with ultrasound guidance, so I do that for my femoral access as well. Well, that shows you how that is done. You can do it in short access or long access, and that's the final position where the magnetic, let's say, cover here is extra covered with a sterile sheath, and you see the arm of here is getting close. It's maybe just touched, but you can easily put the cardio drive here, and then you could have either the diagnostic catheter from the same side or from the opposite side. Now, the experience so far is in three kind of brackets of patients. Congenital heart disease, that's how it started. Some patients with SVT and some PVCs. I'm gonna show you what I've learned over those years. So congenital heart disease for patients, of course, that have no access or have interrupted in inferior cable veins or had many previous interventions, cut-downs maybe as children that result in heavy scarring, and an arm approach is actually quite clever and can go forward. So this is a total of 16 procedures in 13 patients, interrupted IVCs in seven, blocked femoral access in another four, two patients with wheelchair-bound, so they had contractions in their hips, so they couldn't lie flat, and we just thought this is much, much easier to do it from an arm approach, and most of them were with atrial ticardia and a couple of other interventions. I'm just gonna tell you that as we're all done with CART or with a Navistar RMT catheter, I like this example very much because you see here for my conventional, let's say conventional magnetic approach, retrograde, this is not looking really nice because it has this massive kink in it, but if you come from her left arm, you can come down this way and do a retrograde approach. This is a cytosine versus, as you can see, in a really complex situation. Anyway, the whole procedure was three hours and had two minutes and 14 seconds of fluoroscopy exposure for an AF redo procedure. This is the overall access data for those patients, so basilic veins are kind of nice. Probably my preference, the brachial veins are sometimes smaller, but if needed, I put a tourniquet, and the venous access is actually not a difficult thing to achieve. A brachial access in one patient here in this cohort and then a radial access in two more, and you can see the procedure duration here amounts of, in median, about 200 minutes. Fluorotime is about two minutes, exposure's relatively low, and then the ablation time is long because they are complex ablations that we need to carry out here. If you compare that to data that has been published on the magnetic platform, this is a meta-analysis, essentially, systematic review from the Paul Carey's group in Montreal, and it's basically the same amount. It's shorter, but that could be, with the next patient, could be just be slightly longer, so roughly not longer. We have less of broscopy exposure than the overall data, but that's, again, probably a personal habit of having lots of image integration and not x-raying that much, and the success rates are very similar. But then I thought, okay, why are we using it for these niche patients? See, we could probably do very good for normal patients, and the second patient that I ever did, and that's part of this initial case series, was a normal anatomy patient with blocked femoral axis, and I call this the SVT machine, and this is a testament to Pedram's, I think, PVC machine that he suggested a couple of years ago. So SVT machine, you have to think about that as well, so these are 12 patients. The majority is female, a female PI, obviously recruits more women. We just mentioned that on the side. Very normal, normal weight, normal height, and this is an example of a left lateral pathway ablated with N-site X and a magniflash catheter. You can see that we map it essentially the same way that we normally map it. I have a diagnostic, that was a diagnostic non-steroid catheter that by accident happened to jump in the coronary sinus, and we had a beautiful, kind of nice recording on one of the electrodes, and we marked that, and we had a very nice guide already that was why this procedure went actually very elegantly and fast. Of course, the catheter would then be repositioned in the ventricle to be able to paste the V, and we had very nice recordings, and of course, we successfully ablated this. This is an example of a CAR-TOOL RMT-guided procedure for AVNRT. You can see here ablation history. You can cover more features because the system is better connected and better integrated at this point, and you see that we can achieve, again, very nicely, this time with a steroid catheter in the coronary sinus. Very nice kind of orientation, and then also successful delivery. This is the excess data. Bacillic veins, brachial veins, probably equal right and left arm. I started at that point to start puncturing the same arm for the diagnostic catheter and the magnetic catheter. That's something I've learned. It's feasible, very feasible, in fact, and here are the procedure durations. You can see, overall, we take about two hours for this, at least at this very moment. I'm getting better with an excess kind of technique, and then I think this can be shortened as well, under two hours. AVNRT, 90 minutes. AVRT, two hours. I think it's all very reasonable. This is fluoroscopy exposure time in seconds, so around about a minute. You need to take the reference pictures, and then you're basically done with that. So SVTs work really well. PVC machine, I think that was something that we discussed a couple of years ago already. That's, I think, a very elegant way of doing it. We typically combine it with non-invasive mapping, so the patient gets his ventricular maps done on the ward. This is VIVO. Gives an indication with an accuracy of about a square centimeter where the ectopy comes from. Then you put the catheter, a single catheter approach from either the artery or venous access, and then you basically go to the target, look for spontaneous extras, you map, and then you ablate. Again, see basilic veins most of the time, and read an artery in six of the patients that we mapped. Procedure time, again, here about one and a half hours. Fluorotime, again, very little, just because it's mapping integrated. No procedural complications. And the radiofrequency time, again, very comparable to what have been published before. And this is both here to our own comparison group with VIVO mapping where we did mostly conventional ablation. How's the success rate? Actually, really well. You see here pre- and post-halter recordings. Only a single patient had, unfortunately, not a successful ablation. That's someone who has basically a septal origin and ablated from both sides, but I couldn't terminate, well, I couldn't suppress it completely, so she has to come back for a repeat procedure. This is the situation how, after the procedure, we have a swap on the venous puncture, a theraband on the radial approach. This is three days after the procedure, and the patient, of course, gets off the table. This patient was discharged on the same day, had small children, and went home after three hours of monitoring on the ward. What can go wrong? I think with careful ultrasound technique, it's a very safe access route. It's just a matter that you need to train yourself. We had some transient median nerve irritation in a patient with a brachial axis, brachial arterial axis, because you have to push on that puncture, or otherwise it would be bleeding, and that's where we had an issue, and she had some tingling in her three fingers, some three typical median fingers. It all resolved completely. Radial axis is feasible, but the upgrade from a six to an eight French is sometimes unpleasant. There might be spasms, so that's not yet a perfect situation. Ideally, we would have a slimmer catheter to do this so that the change for a larger sheath would not be necessary. Of course, smaller catheters mean that you have to still make a good lesion. PFA, it shouts PFA at me. That would be perfect, and then you could think about actually doing this on a larger scale with a retrograde approach, for example, for AF ablation. So another thought is to use a closure device on the brachial artery. I've not done this. I've not dared to do it, but maybe that's just me. So overall, it's a very successful approach, a new strategy. I think it's about time that we make this move from the groins to the arm and EP as well. I think it's probably feasible manually as well, but I think it's so easy with magnets that I can only recommend. If you have a magnetic system at home and you haven't used it for a while, use it for this, because that really makes a difference, and I'm sure that patients see that the same way. Of course, multicenter trials are the next big step. I've heard here during the conference from a couple of colleagues who've done the same approach and told me that they had no problems at all and enjoyed it, and their patients enjoyed it. So the patients are very happy. I do a lot of video clinics, and I get always the pictures of the patient doing this at the end, and yeah, that probably concludes my presentation. Thank you very much. Thank you so much, Sabine, for sharing this with us and for being such a trailblazer in that conversion from the groin to the arm. I remember Dr. Campos' transition with the arterial access, and I see the same hurdles. For those of you who joined us later, a lot of our speakers have to run to catch buses and airplanes, so we are letting them go. If you have questions, we'll discuss things at the end, and if the questions are really specific to our speakers who have left, we'll make sure we contact them by email or find a way to get your questions answered. Our next speaker is Dr. Jen Silva, who is going to talk to us about the intersection of robotics and AI, and you are also on a strict timeline, so we'll let you go ahead. Thank you so much. Thank you to the program committee for the opportunity to be here. This was by far the talk I was most excited about and the session I was most excited about, and just a shout out to Sabine. She was saying one catheter ablations. Okay, I do pediatric EP. The smallest patient I ever did was 1.6 kilos, and I still use two catheters. I just can't even imagine. Okay, we are talking now about the intersection of robotics and AI and the future of EP procedures. It's a big topic, but let's just start with this. AI is more than algorithms. We need to throw away this notion that an AI is a CNN, some sort of neural network. It's not. It is more than that. While certainly algorithms and machine learning are an important part of AI, and we know that the machine learning itself is what branches out into supervised or unsupervised learning, deep learning, and quite frankly, reinforcement learning. You know what the other word for reinforcement learning is? It's called robotics, quite frankly. But AI also includes the internet of things, natural language processing, which is something I think is shown to be of great interest, particularly across medicine, particularly in electrophysiology, extended realities, computer vision, and then of course, generative AI, which I feel like you'd have to be living under a rock to not have heard about recently. So how do these technologies fit together? And I sort of took that question and then flipped it on its head and said, what is the EP lab of the future look like? So this is my current EP lab. It's small, it's quaint. Like I said, I'm a pediatric electrophysiologist, so we have sunshine and birds in our room, but it's not probably that different than your guys, other than being maybe a bit more colorful. Oh, and my patient having a blood pressure of 51 over 30. But the cardiac EP lab of tomorrow requires enabling technologies. I think we can all agree to that. And I think they need to provide holistic solutions that improve visualization, connectivity, physician control, physician performance, and inherently, that is going to lead to better patient outcomes. For me personally, those of you who know me, I think that this comes from medical extended reality, and that spans a cycle of things, starting with virtual reality. Virtual reality is when you have a fully digital environment replacing your natural environment. Think of the Oculus. Augmented reality, that's where digital things can get added into your natural environment. Think of things like Google Glass. Mixed reality is sort of an integration of augmented reality, but now adding the ability to manipulate or move those digital images that appear in your natural environment. And then lastly, I feel like we need to talk about pass-through AR with the release of the Apple Vision Pro. Pass-through AR is a little bit different. It basically scans your natural environment and says, I'm going to recreate that within the headset, and then I'm going to allow you to import digital images into that environment. So pass-through is a little bit, whoops, that went all the way, didn't it? That sort of lives more closer to virtual reality than I am personally comfortable with using in the lab. So what's interesting about medical extended reality is that it lives at the intersection of big tech and med tech. So what do I mean by that? If you look at the companies that are listed on this slide, they are Meta, Google, Apple. But I'm not talking about that. I'm talking about what we do, right? What we do in our clinics and in our labs. So I think the lab of the future probably looks something like this. You have a physician who's using a headset, and instead of the background, can now have virtual screens, can have a 3D map truly in 3D with ECG control and analysis, has ultrasound and tool tracking ability, has the ability to do eye tracking so you have a better sense of what your resource utilization looks like, the ability to have multimodal image integration, workflow analysis. I think this is a really underappreciated aspect, but as I build out this magical unicorn of a new lab that I'm supposed to be getting three years ago, the workflow analytics are really critical to how you design your space. Inherently, this impacts robotic navigation. It also impacts telerobotic navigation, but I'm not gonna get into that because that's still a little bit above my head. Natural language processing for generated case reports and case notes, and then of course, let's not forget procedural sedation. There have been studies looking at the use of this technology, not just for the physician in the room, but for the patient in the room. And then lastly, I feel like I'm going to die on this mountain of EMR integration because we can do all this, and if it doesn't integrate or we can't get our data into the EMR, we can't bill for it, and if we can't bill for it, our hospitals aren't going to let us do it. So I envision that technologies that can work together in a sandbox that looks like this. By the way, each one of those yellow boxes are its own form of AI. That's what the lab of the future looks like. I only hope it gets here before my back goes. So what's the result of this image integration? I think it results in a couple of things very clearly. One is enhanced precision. We're going to have personalized treatment strategies, real-time imaging, visualization and integration, automation, and then improvement in both physician and patient outcomes. We need both of those things to happen. So the current state, you know this better than I, we know that robotics are currently deployed within EP. There's many of them. But what we also know is that there's going to be improvements in hardware. We know that's coming. A robot was built here on the expo floor. It was taken down. It'll be taken down today, and it'll go back to its home. But we also know that there are even more mobile units that are on the horizon. Couple that with improvements in software, particularly in interface. And we'll get into that in a second. And improvement of disposables, or the catheters, quite frankly, I think is going to be really critical. So enhanced precision, we need things that increase our tip mobility, that allow us to get to difficult-to-reach locations. And inherently, that's going to improve your precision, right? I don't feel like this math is hard. But robots let us do that. So we know that we already have flexible catheter tips, if you went down to the floor. You got to experience that yourself, hopefully, at the stereotaxis booth. You can have improved catheter mobility. You can access difficult-to-reach places. And you can actually have nice, stable lesions that you're forming. But what we don't currently have is limited to two-dimensional mapping, right? And as a side note, I'm sorry for the goofy formatting on the slide, by the way. As a side note, I took my, I was telling Pete this, I think, I took my 14-year-old daughter and 11-year-old son to go play in a wet lab at a robotics company. And my 14-year-old daughter was very good at moving the catheter around with her hands. We said, go here. And she could physically move it and make that catheter go. And my son said, you're ridiculous. Give me that Xbox controller. And moved the magnets around. And he said, just push. And got the tip of the catheter to exactly where he went. What he has that she has not developed is an ability to look at something 2D and know it in 3D. Some people are gifted with that. Some of us work our careers for that. I certainly feel like I worked very hard early in my career to develop that sense. Some people, and we know who these people are, don't develop that. But that doesn't seem very fair, right? So what we've been working on, as most of you well know, is using MedXR to take those 2D things and turn them into 3D and just say, doesn't matter if you can't see it in 3D. I'm just going to go ahead and show it to you. And so we can use our electroanatomic data to develop real-time, three-dimensional images of the geometries that we're creating with the real-time catheter locations with an eventual goal of widgetizing the entire procedure. So this is what system one looked like. You put this on your head. It is a gaze-controlled system. So that little white dot moves around as you move your head around. You then, as you have your model, you can move it around the room. And then you lock it into position. Once it's locked into position, it becomes like another permanent object in your room, like your boom, right? So you can look around it, you can look to the left of it, you can look to the right of it, and it stays still. You have a clipping plane. Our clipping plane is actually now, I like to tell people, it's your nose. So if you move your nose into the model, that's the clipping plane. You can create joint sessions. This is really important for those brave souls that train fellows. I am not one of you, but it's gonna be important for that training cohort. We all know we like to move our maps in unique and distinct ways. And so we give you the ability to do that without asking your mapper to please move that map for you in a certain direction. Or more importantly, I meant the other right, which is often what happens when I get not my usual mapping technician. So we know that this can be done, and we studied this in a prospective study across two sites in Boston with eight users enrolling 100 patients. Enrollment, we actually were originally gonna enroll 350 patients, but enrollment was terminated early because we had met endpoints and our users were tired of using it on protocol. And the endpoints were looking at accuracy, communication, and usability. And this, I think, actually JAG showed this last year in the plenary, but this is Dr. Singh doing an AF ablation using Centi-R. Okay, so what do we know? We know that the physician's ability to navigate accurately was improved when using Command-EP. They were better able to navigate within a four millimeter distance from a target. They were using four millimeter tip catheters. So I expected that. Our previous data had showed that. And it was actually 75% of physicians overall who performed better in all cases when using the system. Here's where my hypothesis was wrong. I thought there was gonna be a user difference by, what do we call it, years in practice, let's say, partially based on my experience with my own children. However, all physicians with more than five years out of practice did better than users within five years from practice. I was a bit perplexed by that. I really thought that our younger users were gonna far outperform our more experienced users. Incorrect. As it turns out, there's a theory in human factors engineering, which is an important thing if you do device development, that tells you more experienced users do better with integration of new technologies because they can rely on their experience and focus on what you're giving them rather than trying to make up the experience and use new technology when you're using them. And I think this is really important for those of us who are trying to bring new technology into places. We have to really think about that and not fall into the trap that I did. Okay, personalized treatment strategies. I really like the virtual heart arrhythmia ablation targeting. I'm sure many of you have seen this if you've ever met Natalia Trajanova. What is she doing in her lab? They are doing computational model reconstructions from pre-ablation MRIs, then doing a personalized ablation simulation. These data that I pulled are for the VT simulations. They create a personalized ablation strategy for that patient, export the plan to Carto, and then you can import it while you're doing your case. And so the VT induction, I think I have a video, yeah, looks something like this. So once they do the modeling, you do some pacing, and then you initiate a VT, and you say, okay, here's the VT, here's the spot we want to ablate, and then you put, they drop that target in the model, and that's where you get your data set from. This has been understudied both in an animal model where there was some success with it and is now in human studies. Oops, sorry about that. So knowing her data, we went to Natalia and we said, hey, we know that we can get people to navigate more accurately. Do you think you can simulate some ablations and see if accuracy matters? It seems intuitive that it should, but what does that actually look like in a simulated model? And what she was able to show was that we were able to decrease the number of VT re-inductions after simulation when they were using the more accurate lesion set. So again, not particularly surprising. It seems like it would make sense, but we felt like we had to also prove that. How about real-time imaging visualization integration? Look, the fact of the matter is, there's a lot of data, right? We stand in our rooms and we have our mapping data, we have our ultrasound data, we have pre-procedural imaging. So there's lots of inputs, there's different places to look, and this was another problem I felt we could potentially solve for. So what we were to do is create a virtual screen module, and what we did was we took the pieces of data that you needed from the room when you're doing your procedure and integrated them all into the headset, in this case with the hologram in it. So when you were doing your procedure, if you wanted your electrograms, I am old enough that I still need my electrograms near and dear and close to my face. Your ablation parameters, ultrasound, what have you, you could do that. And so this is a picture from a pig lab. You can see here we're using ultrasound, we're double-checking with our map, we have our real-time electrograms, our review screen, and here we're performing an ablation. So you can also see in the back here, that's the boom, pushed in the back, out of the way, in the corner, all turned off, because we just don't need it at this point. Okay, so what does the future hold? So if I was to ask Santa for a gift, I think it's a single unified model with co-registered images presenting us with 4D data. And what do I mean? I mean, X, Y, Z, and time, right? Because we know that that changes over the course of a case. And I think that, so automation now. So think about that, take the piece of automation. You can do a virtual EP study, you can have your personalized approach, you can have a combination of manual and robotic ablation, you can have your 3D interface, and you should be able to take all of that, Santa, and preload it into a singular system to perform first-pass ablation on patients. Now, is this gonna be enough? No, of course not. I'm not saying all of this is gonna replace us, but it is certainly going to make our job different. It's gonna allow us to do the fun part, quite frankly, of what we like to do. I'm gonna skip over this. So what does the EP Lab of the future look like? This actually came out of a paper published in 2019 in Jack Cardiovascular Interventions, and I really don't like when the interventionalists, interventional cardiologists, think they can do this in front of us. But the lab of the future looks like this. It has an augmented reality system in it. It does have voice-assisted control of systems. It will have clinical decision support. We didn't even talk about all of the data that we are generating in the lab, and if we can tag properly, will lend itself really nicely to, yes, algorithms and neural networks that will be able to help us during our procedures. And then lastly, robotic access, whether it is in-person or tele-robotic. So in summary, I actually think the building blocks for our lab of the future are emerging. I don't think we have to wait that long to see many of these things. The advances in robotic hardware, software, and disposables is a really important advancement in our field. So my call to action and people, generally I think if you're in this session, I don't need to say this, but please give your feedback to these companies. They really need it, they value it, and it will influence what we get downstream from them. Integrating robotics with other forms of AI, including MedXR and computer vision and machine learning are gonna transform our field. Now, I will say, the physician in me says that sustainable change will likely be incremental. The technologist in me believes Larry Page. Especially in technology, we need revolutionary change, not incremental change. The problem is, we treat people, we treat patients. And in medicine, it's going to have to lay somewhere in between. With that, I must acknowledge all of these wonderful people who allow me to do what I do. I'm so grateful for them. Thank you so much. Thank you. Just fantastic talk, super inspiring. So, fantastic. And let's move on next to, I think, Dr. Burkhart. Okay, gotcha. Oh, gotcha. What's that? I thought it was last. We're okay, yeah, that sounds good, yeah. And so, David Burkhart's gonna talk to us about new technologies, new catheters, broadly accessible robots, digital surgical and support tools. Thanks. We're keeping the audience on their toes, shifting everybody around to accommodate schedules. Excellent. Thanks, everybody, for staying for the last sessions. This is fantastic. I appreciate you being here. I gave the last session at CardiaSTEM one year, and not even the chairman showed up. So, I'm pretty happy that we do have somebody here. So, I'm gonna talk, the good news is that over the last 20 years, we have not had much innovation in new technologies and robotics. In fact, if anything, we've lost robotics. We lost Hanson and other systems. But now, we're actually starting on the horizon of new development within the systems. Most of this is within the magnetic navigation system, which is what we'll focus on. Limitations to manual navigation are really getting to the optimal location and maintaining consistent contact force. This is most consistent in the ventricle, as you have probably seen over the years, and as we discussed about. Atrial navigation, not very difficult, particularly with the new tools, has not been an issue. Ventricular navigation, however, certainly has been an issue. Robotics really improved ventricular navigation in terms of getting to the optimal location and maintaining contact. And here, of course, the example, using the robotic magnetic system, you see really consistent contact, both on ice as well as fluoroscopically, as well as being able to perform maneuvers that are nigh impossible with manual catheters, such as retrograde approach to the left atrium, as well as a transeptal approach coming to the aorta and coronary artery. The other difference here, and this has been quite misunderstood, unfortunately, Dr. Packer, I think, was the original to perpetuate one of the myths of this. His initial report at HRS years ago was that you needed at least 60 grams of contact force to have a significant lesion. That didn't account for several things, and that one, we proved that it was dangerous in our very close subsequent publication. The other is that catheters are very different from each other, and the most different catheter is the magnetic catheter, you see, which is nearly always in contact, and it creates quite a different lesion at lower contact forces. And here, really true to what was said, this is the initial, one of the initial publications, using contact force catheters, once again, suggesting higher force was important for lesions. However, what we saw, that the complication rate was really unacceptable in the group using contact force. So now we finally have, on the horizon, eventually new magnetic navigation catheter. And here, you see a version of it that can be very precisely rotated. And here's another myth that, based on this video, I'll show you, in that it was once said that the catheter was not pulled to the surface of the heart. And as you can see in this video, clearly, that is exactly what has occurred, is that you can pull it to the surface and keep constant contact. A good part about the catheter, one has more magnetic force, so more physical magnet in the catheter in different locations, which allows it to improve navigation. Also, just the force, the actual makeup of the catheter makes it a little more pliable. Has a more modern tip, and so, once again, we were using the old thermocool tip technology from greater than 20 years ago. And also, this can be used as a platform, which we will talk about. And so, here is navigation. You see that, in comparison, this video will play, you see really what's quite different, that the tip stays in contact with forward force as opposed to going side to side. And that certainly is going to give better lesions. And that you see, once again, with a catheter fluoroscopically, very consistent contact in areas that tend to be potentially low contact force areas. Here, once again, you can use this transeptally and retrograde in both ways, and have very good contact in locations that, once again, tend to be very low contact force areas. Once again, also has a more modern tip to create better lesions, more uniform cooling. And then, in addition, as opposed to being locked in with software, this is more of an open ecosystem, and can be used, potentially, with any mapping software. I'll go forward. Stereotaxis has partnered with Abbott to have a more streamlined and partnership in this. And that's so we can navigate within the mapping system of Abbott. And that, here, you see that the magnetic vectors in that, and synchronized rotation, and keeping the vectors in the field and that's, you see the location is integrated and will eventually be integrated throughout on both systems and complete integration is what we're hoping for. And then once again, this can be used as a platform and so all you can do, all you have to do is change the tip, use the basic shape of the catheter and the magnetic force of the catheter and you can make this a magnetic mapping catheter as well as other catheters. And some of these are in development. Also with the iConnect module, this allows you to get a version of contact force using the magnetic system. Now, one of the other things is that once again, as this meeting has been full of, we've moved on to other ablation technologies and so pulse field ablation appears to have some advantages and includes mostly quote non-thermal, there's certainly some thermal effects, rapid delivery, more selective in terms of its tissue injury and potentially more effective at durable lesions. Not as reliant on contact force, contact is important, does need to be consistent contact but not necessarily the higher forces that you'd need with radiofrequency ablation. And that here you see not all PFA is the same, there's various different versions of this but almost all of them, consistent contact is very important and one of the more effective methods of making sure you have a good lesion. And so PFA, once again, rapid, effective, safe, high voltage over a very short period of time and then once again, being in contact is very important. Combining this with magnetic navigation solves a lot of the problems that are potentially available. So consistent contact and then having an open system. So this has been studied using the Galaxy system with the MAGIC catheter in Europe and once again, you see the different type of contact and then using this catheter and very good contact and when you apply, you see very good lesions occur here in this last one. So the bright space, if you're not familiar on ultrasound, is a lesion. Once again, that's a very good, very deep lesion there on the septum. Here, this was studied and that you see using two different catheters compared to a manual catheter and once again, very similar lesions in terms of width and depth. Here, physically seeing on the system and that you see the catheter placed into position, the PFA being delivered there on the screen and end of the lesion and then necropsy of the animal, you see transmural lesions, two and a half millimeter depth in the atrium in this case. Also, performed lesions in the ventricle. Once again, very similar. You see the map and the interaction here. PFA turned on here and then once again, necropsy performed showing very nice lesions in this case and so other catheters. Robotic catheters are also coming. APT has been acquired by Stereotaxis and you see their suite of catheters and then what we expect is that their catheters will all be magnetized so these can be done with remote navigation. There you see their catheters, CS, HV and a trideca catheter so you can perform rapid multipolar mapping and substrate mapping of atrium, ventricle, anything you like. There, their CS catheter which I've used. It's a very nice catheter and putting magnets on it would certainly, I think, be very helpful and their trideca catheter once again. And then here, the magnetic versions of these type of catheters is what we would expect. And the good news, since this is an open platform, there's multiple companies who are potentially going to be involved. Here, you see a freezing type of catheter, a robotic magnetic lasso type of catheter and once again, what we talked about in the Abbott catheter with a multipolar catheter used mostly for ventricular substrate. And then another catheter is in the vascular space so ultrasound as well as sheaths that you can place wires through that are magnetic. This is very interesting for me. I used a magnetic wire, the first magnetic wire 20 years ago. I could get that thing anywhere. We initially used it in the coronary sinus, some branches of the coronary sinus before there were any sheaths available to get in those locations and I could get that wire in any branch of the coronary sinus. I couldn't get a lead to follow it because there was no, they had no sheath that had support of it but I could get the wire anywhere and I could certainly test it and I could get it anywhere in the brain too. So that is very interesting and look forward to that. And we also have new robotic systems now and so you see the generations of systems and this is the newest system, the Insight X system. The part about this, this is more mobile. It doesn't require all the shielding used and nearly a portable type of system. Here you see the NIOBE 2, this is the one actually that I continue to use, the Genesis. Genesis is a significant upgrade, significantly faster movement of the magnets and more potentially higher Tesla forces, not yet approved by the FDA but can potentially be done and then here the newest one. Once again, doesn't require all the shielding, can be nearly completely stowed, smaller and easier to place in laboratory systems. The only downside from that is that the magnetic force is a little lower at .05 compared all the way up to potentially .12 in other systems. There you can see it can be fully stowed and essentially non-magnetic at that point and so if you have a system right now, the area that you're not supposed to be around the magnets is essentially taken away when this is fully stowed. So whether the new system benefits smaller profile, no shielding, less construction issues so less overall potential cost for implantation of the system and opens the platforms outside of EP, like I said, interventional neurology, radiology, I think are very exciting for this. With the new limitations, reduction in the maximal magnetic field so the currently approved United States catheters are effectively won't be usable with this system at .05, however, the new catheters that we expect to be approved with the higher magnetic force will be able to be used here. In conclusion, there have been significant developments recently over a long period that we had not seen improvements, both in ablation systems, catheter systems and the actual magnetic systems themselves. Thank you very much. Thank you. This was very informative. We will continue on with our last speaker for today, Dr. Daniel Cooper, who will be talking to us about the paradigm shift with PFA and automation and along the same notes. So the floor is to you. Wonderful. Thank you. Last absolute talk of heart rhythm. I'm honored. I'm amazed people are still here, but so as my talk comes up, let's see. So I have the honor of discussing the role of robotics, automation, and PFA and how it could be a paradigm shifting technology. When you think about where the digital OR or EP lab is heading into the years to come, it's hard to imagine it without a robot firmly in the center of it. On the left, of course, is the Da Vinci surgical robot, which is exploding in the surgical space, particularly in urology and ortho and beyond. And then on the right, of course, is the stereotaxis genesis, which is the market leader in robotic EP. And the robot is the centerpiece of the digital EP lab, but it must be surrounded and supported by digitization of the other elements of care during the pre-procedural, peri-procedural, and post-procedural times. And as you know, there are a multitude of efforts designed to improve target planning. You've seen some of them in the earlier talks, looking at imaging and predictive analytics with integration into our mapping and robotic systems. On the left are the various modalities like VIVO and Vector and CardioInside and ADAS and InHeart that try to identify exit sites and points of origin and arrhythmia substrate before the procedure to help you with ablation planning. In the middle is, of course, the incredible work by the TriNova lab, which essentially is using virtual EP studies and personalized ablation planning through creation of a digital twin, again, pre-procedurally designing a target plan to be applied. And then we have all of our peri-procedural tools that continue to evolve, like Insight plus Grid, ILAM-guided VT ablation, AI-guided AF ablation with solutions like Volta Medical, leveraging all of that incredible amount of complex data that we gather from our multi-electrode catheters to help guide our ablation targets. Now, you can lever that, leverage that information to create a targeting plan. And in the robotic world, you can dictate that target and let the robot go to work. So, on the left, you have the operator taking his or her hand off the mouse and the robot is creating a left atrial geometry in quick fashion. On the right, again, the operator takes hand off the mouse after analyzing the geometry, creates an ablation plan, and then the ablation tool gets to work. And the only question is, you know, what type of ablation technology is being utilized by that robotic catheter and how does it impact outcomes and safety? All the automation and fancy pre- and periprocedural data interpretation and robotic navigation is, of course, great, but if you can't deliver an effective lesion or treatment, it doesn't matter, right? On the left, of course, you see the traditional products that we use with thermal point by point ablation and cryo-balloon. In the middle and to the right, you have all the incredible tools that's part of the PFA revolution going on right now, the Ferrapulse and the Pulse Select and the Afera and the Veripulse and the Volt, which is about to be approved. But the ablation technology used in the future digitized EP lab must reach and durably eliminate the target arithmogenic substrate. And so, now, with these PFA tools off to the races, there's a great desire on our part as operators to see that happy marriage of these technologies onto a robotic magnetic platform. We've learned a lot over the last 18 months about PFA, particularly about the need for stable contact. In the top left, you see the work by Madison et al. from 2023 that looked at a couple millimeters off the tissue versus zero to 10 grams and then upwards in terms of contact force. And what they discovered in that ex vivo non-motion model is that increasing contact force really had minimal effects on acute lesion dimensions in that non-moving model, but achieving tissue contact is of the utmost importance, even more so than the total force, okay? Now, when you take that into the moving heart, of course, there's a little bit of difference, particularly with manual catheters. On your top right, you can see that manual catheters rely on a sufficient amount of contact force so that you have that steady, continuous contact, that as you look at that raw contact force data, nothing is going below 5 grams when you start with an average force of 30 to 50 grams, as you see on the right. And by doing that, you can achieve a good lesion, a good deep lesion. Okay? On the bottom left, you see the work by Nisetal in 2024 showing that as the number of applications increased from left to right, the chance for hemolysis goes up, particularly in those situations where the electrodes have no contact. So, again, showing the risk of hemolysis in that situation. So, in summary, contact is important, stability is vital to effective lesions in this environment, sliding along tissue decreases effectiveness, and no contact lesions can actually increase the risk of that ablation application. So, it sounds like a perfect environment for the use of a tool like the MAGIC catheter that Dave showed you just a few minutes ago. Here is a great example with ice showing kind of a classic example of us targeting a papillary muscle with the MAGIC catheter on the left. The contact is steady and stable, and probably in the neighborhood of between 8 and 15 grams of force, and you're getting a nice hot lesion right here. And on the right, you see the manual catheter sliding along the papillary muscle, creating a little bit of effect on the tissue, but probably not the durable lesion that you're looking for. And, you know, the only thing that could make the left picture better is can we potentially remove that last remaining bit of risk by removing the thermal ablation risk to esophagus and phrenic nerves, and even steampops without creating new risks such as hemolysis given the stable continuous contact. And so, work is being done on the preclinical side to try to see if there's compatibility between some of these products and the magnetic robotics system. Here is a collaboration with Stereotaxis and Cardio Focus's Centauri system that uses a generator attached to a conventional catheter to deliver PFA. They looked at all chambers, so this picture shows you in a swine model going from the SVC to the IVC applying six lesions from top to bottom with pre and post voltage maps showing a nice line of conduction block along here with pathologic slides showing kind of continuous lesions on the atrial myocardium. They also went into the RV and the LV and applied three applications in both chambers and then did a post and looked at the lesions. The width was between 13 and 22 millimeters. The depth was as deep as nine. Again, very early in the experience but encouraging that this is possible. So, in summary, they saw effective lesions delivered in all four chambers. They didn't see any micro bubbles along the way, no char or coagulum along the way. All lesions were located when they did the gross path. The lesions in the atrium appeared continuous and the ventricular lesions that were spread apart were of significant size and depth. Importantly, the operation of the generator system was not affected by the magnetic fields of the genesis system and this procedure provided evidence that this combination could potentially work with the new MAGIC catheter. So, robotics plus automation plus PFA, in summary, what does it offer? It offers precision and stability within a challenging anatomy, something we've known for decades using the stereotaxis system. We're excited about the opportunities for integration with pre and periprocedural imaging mapping data analytics to make our lives even better and to make our procedural outcomes improve. This system, particularly paired with PFA, can democratize procedural outcomes across all skill levels and levels of experience. And at the end of the day, in my mind, this makes effective ablation as safe as you possibly can make it. Thank you. This is it, this is the end, this is the end of the 46th annual meeting. Thank you everybody for your participation. Thank you for staying until the very end. If you have any questions, please bring them up, don't be shy. Otherwise, if you are shy, you can contact us at any time, our co-chairs, our speakers, and please join us at the next meeting. You've heard, you've seen the advertisement, you have the leaflets going around the room, so please join us, stay involved, get involved, this is interesting.

electrophysiology

remote techniques

robotic systems

pulse field ablation

telerobotic procedures

AI in medicine

augmented reality

catheter technologies

3D models

automation

cardiac care