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EP on EP Episode 89: Hypertrophic Cardiomyopathy a ...
In this episode, Eric N. Prystowsky, MD, FHRS, and ...
In this episode, Eric N. Prystowsky, MD, FHRS, and Martin Maron, MD, discuss Hypertrophic Cardiomyopathy and SCD with Martin Maron, MD
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How are you? Hi, Sarah. Prash, I think you're muted. It's always gonna be a problem, isn't it? How I... 100%, you know how life is. Yeah. Sarah, Dr. Allamah just called me. I think, you know, we are not live, right? We are not, no one is listening. There are attendees who have already joined. Okay, but they can hear what we are talking about? Yes. We don't have a private place for the panelists to discuss and plan our things? Hang on one moment. They can see and hear. Hang on one moment. Is Jordan joined? Did Jordan join us? Yes, she did. She is here. Jordan and I are both here. Dr. Temerisha, how are you? Yes, how are you? Hey, good, good. So we don't have a private... Oh, sorry, go ahead. No, Stephen, I was thinking, you know, do we have a private room just to discuss like the plan or just like we do for the webinars? Understood, yeah, we were going to, just based on this being a pilot, we haven't been able to set that up for this particular one, but we could do something offline if you wanted to just do a quick secondary meeting or something, but for the pilot, we weren't able to do that through this one. Got it, okay. Okay, so then I'm just thinking, I think everyone should be ready. I will, Prash, I think everything is ready from our end, right? I think we're good, but we could hop onto another call if you want. That's what I was thinking. I think it's a better idea. Sarah, do you want to quickly send out a message and we'll hop on the other call? Just another Zoom, just private Zoom. That way we have time. You with us, Sarah? All right, what I'll do is let me see if I can- Apologies, yes, I can do that. Jordan, would you like to continue sharing the screen though? This is my screen share, so when I pop out, you'll need to. Sarah, just remain in the call. I'll handle the extra meeting with Prash, Dr. Tamarisa, and everyone, all of our need to meet in that second room. So you just remain sharing and we'll keep everything as is right now. Hey, is that Jordan? Yes. Yes, that's me. Hey, Jordan. So a couple of things, if you and Steven, I know it's a pilot, so it's a first time live one, but two things I need help for your expert guidance, okay? Because we want this to be super successful. I know it's first time, but let's make it super wonderful. Dr. Allamad's slides, if there is a way for him to share his screen, same thing for Dr. Natale, then they can use the pointer, they can, instead of saying, next slide, next slide, I think it'll be very smooth. Do you think you can do that? Anyway, we are doing that with Dr. Natale's slides. Yes, panelists will be able to share screen. Yep, so I'm going to create the secondary meeting for us, give me about two minutes. Okay, so Steven, those two are the only speakers and there's Dr. Natale and Dr. Allamad are the only two speakers. So if you can just, if you both can help us, so that way they can share their own screen. Because saying next slide and without the pointer, it becomes difficult, so. Yes, all panelists are enabled to share screen, but we will confirm, we will make sure that that happens. Appreciate that a lot. Thank you, thank you. You're very welcome. So I guess we'll wait for Sarah to send us a new link. I think Jordan is sending that now. And I did just promote Dr. Allamad to panelists. So Jordan, if you could take a look and make sure that came through. I'm doing so right now, just give me one second. Yes, I think he, yep, he is, I see it, yes. So Dr. Allamad. Can you hear me? Yes. Can you guys hear me? Yes. Okay, yeah, I was on it for a little bit and nobody could hear me. Okay, let me do this. I'm going to send this to all of our hosts and panelists right here. Hey, Sarah. I am in Hawaii. Hey, Prashant, how are you doing? Yeah, good, thank you. Sarah. How is it there? No, we're early in the morning. It's the start of the day. So it's not bad, huh? That's not so bad. That's not so bad. Yes, Dr. Tamariza, did you need something? Yes, Sarah, I know I do sound like a squeaky wheel. I'm going to repeat myself. We should not have any issues with sharing the screen on the part of Dr. Allamad and Dr. Natale because the rest of them don't have slides. So if just ensure, double check, now that he joined, let him share the screen. Let's see. Let me try and do it. Okay, thank you. All right, let me. I'm going to go to share screen. You cannot start- I need to stop sharing what I'm doing right now. Now you should be able to share. Okay, Microsoft PowerPoint, share. And can you guys see the PowerPoint slides? Oops, let me make it into a presentation mode. I already have it in presentation mode. Excellent. Yep, let's run. All right, that works actually. Is there a way you guys can see my arrow? Can you see the arrow? Yep, we can see it. We can see it, perfect. Okay, that's wonderful. All right, I'm going to un-share, stop share here. Great job. And so what I'll plan to do, just so, I don't know if we're all on absolutely the same pages. I will plan to share my screen for the introductory slides. And then when Dr. Al-Ahmad, when it comes time for you to speak while your introduction is, you know, I will have my slide up for your introduction and then I will stop sharing at that point so that you can share. That sounds good. Yeah, I'm really going to try and talk a little bit about some of the animals work. The problem is it's, each one is a little different and I'm going to try and emphasize that, but I'm not really going to go through all of the animal work with every single particular catheter, just demonstrate a few different concepts mostly. And then I think Andrea will take the clinical stuff and then we can have a discussion. Yes. So, hey, Prash, did Michael join us? He hasn't joined yet. I got a message from him saying his registration button was, or not his registration, his join button wasn't showing up. So in the meantime, Prash, would you be okay if we just ran through the script in case Michael has an issue just so we both, is that okay? Yeah, yeah, sure. I believe Jordan has placed in the chat for you all, for the host and panelists, the other webinar, the link. Okay, I'm looking. Looking at it. I've got no chat on mine. I've got questions. You should have Q and A and a chat. I've got no chat. Hold on, unfortunately, Jordan came, got bumped to set up this other meeting. She'll be right back. No rush, no rush. I think we can just discuss here, Stephen, that way, you know, because we have only 15 minutes. Prash and I, when Michael joins, I hope it's a link works. Oh, there's Jordan. There she is. Okay. Yeah. So I think I had the script laid out. Sarah will start off with the first slide. Important slides for Sarah to show would be the disclosures because this is a CME event. We have to make sure we run through the disclosure slides. And I think she and I spoke, you know, because if it's a CME event, the disclosures have to be shown. After that, once Sarah is done with the housekeeping, Prash, if you're okay, I think I'll just go with the same schedule we both and Michael had written down. I'll just introduce the thing and I'll introduce right here. I'll go ahead and do introductions of both Andrea and Amin. That way, you know, the introductions are done. Then I'll invite you over as a co-chair and then you will take on, introduce yourself. And then you will be introducing the three panelists. Sarah, can I interrupt? Sarah, can you add Javier as a panelist, please? Because he's not able to get on. This is the same problem I had. He was not added as a panelist for a while. Yes, I will take care of that. Thanks. And then I tried to call Andrea. He was doing a case. He told me he might be. A few minutes late is okay. Yeah, that's okay. Yeah, no, no. I just want to make sure because I don't think it's as straightforward as her logging in as just joining a Zoom call, in other words. I have promoted both Dr. Schmidt and Dr. Sanchez now. But Dr. Schmidt is, yeah, he's showing. Sarah, make sure the social media people are also as panelists. They got to join us. Because I would like them to be on the screen too, please. So Dr. Natale should not have a problem because make sure he, the three social media and Dr. Lloyd. Of course, I don't see Boris yet. Oh, Boris just joined. And Melanie still joined. Good, Clinton joined, waiting. Good, excellent. So Prash, moving forward with, interrupt me. So I'll give the platform to you and you'll do the introductions for all the three panelists. Then if you can hand over to Michael, he still hasn't joined, but he'll be there. And then he will introduce, about the social media influencer because they're helping us. Then I will hand over to, he'll give it to me and I'll basically remind the audience about the chat box for Q&A and invite Dr. Allamah to take the platform. And Amin will do his talk. After that, you, basically Michael thanks Amin and invites Andrea. And then you come on after Andrea saying, thank you. And then you invite the panels and each panelist, maybe they can just give one to two sentences, expert sentences based upon the presentations, however long they want. And we can go through that. And while you're doing that, I'll keep an eye on the chat box and we can take turns. Is that okay? Does that sound- Perfect, perfect. Sarah, can you let Murdad in as well, please? I did do that. He should be showing up. I will try again. Yeah, let me call Natali. Can you even text him? Okay. Michael's here, which is good. Oh, I love it. Great. Sorry guys, I had to re-log in as a learner. I was an administrator. Too much power. Yeah, right. Kamala, are we gonna do these bios the way they're written? Are we doing that? I think we can use it as a platform, but I think you can just introduce as you need to. I mean, some are lengthy and some seem unusual about accepting all insurance programs. We don't wanna- Michael, Prash and I, we just discussed just the flow. I saw, I heard that, yeah. So you will be coming on after Prash. And just the three social media influencers, see if you can just introduce them and thank them for their time, please. And then you will, let me see. After Amin presents who you are introducing, I will introduce Andrea, right? Yeah, but you're not doing the long end because I'll already introduced both Andrea and Amin at the beginning. Perfect. So you will just say, thank you Dr. Lamar for this. And then I'll invite Dr. Natale and with his title. That's it. And did you speak about the feeling of the questions? How are we doing that? Yes, the question. So I was thinking Prash will take over as soon as Andrea is done. Prash basically takes it on and thanks Andrea, invites the panelists and engages them. In that time while he's driving that, you and I can look at the chat box. I'll take the first question from the chat box, whatever. And then you take the next and go to Prash. We go in the same three circles and make sure all the three panelists are engaged. Hey, Boris, Dr. Schmid. Hey, good evening. How are you? Good, good. Thank you for joining. I think Andrea is done with the speech. Welcome. Thank you. Yeah, you're muted Melanie. Thanks for inviting. I saw you wearing a tie, so I ran downstairs to get one. Yeah, I was just, maybe I should change. I know, I was just about to tell Melanie, I put like, you know, I put a jacket on, you know. I think it's too late for me to change. You look great, so don't worry. Andrea finished his case and should be joining soon. Just keep an eye out for him, Sarah, please, so that you can bring him into the room. Yes, absolutely. I will do that. So, do I see Sanchez? Javier, yeah, Javier's room is seen. I know he's in a hotel. He probably put the jacket on. Hey, Melanie. Hi, nice to meet you. Hi. Nice to meet you, too. All right. Okay, I'm making sure everyone, there is Javier Sanchez. Hey, guys. Good. Mahak, Clinton. Good. I think the only presenter we're still looking for is Dr. Natale. And as Dr. Al-Amin asked, I am keeping a keen eye out, and we'll take care of that promotion as quickly as possible. He told me he had already logged in before he started his case, or at least knew how to do it. So I'll check in with him in a minute and just make sure he's good. Yeah. I hope he didn't log in as an attendee, Sarah. No, I'm not seeing him there. Okay. That's where I'm looking to make sure. Okay. Okay. Attendees. I'm looking at the numbers. I know with the time zones and this is our pilot. Live webinar. So Prash will probably say more than me. First time we are doing a live webinar across the world. So we need a lot of patients. Okay. Do you know how many people are attending? I think Sarah, correct me if I'm wrong. I think it's close to more than definitely more than 700 attendees. 700. Put on a tie. That's exciting. Come on. You should be proud. Yeah. Yeah. Thanks for the invitation. I'm really happy about it. Yeah. The credit goes to Prash for inviting you. Well, you guys brought the crowd. Okay. So just to review. And I know we'll let Dr. Natale know this when he joins as well. When it is time for our speakers, I will stop sharing so that they are able to share their screens with their slides on them. Until that time. They won't be able to share. So don't be alarmed by that. We will be able to put your slides up on the screen. And just for us all, I know we have done. All of us have done talks and all these, but we got to remind ourselves to mute when we are not talking. So there's no. You know, Thank you. And just a piece of housekeeping for you all, I do have a brief introduction once we get started with the webinar, and at the end I will close this out with a reminder to our attendees about how they claim their credits. So I'll take care of that information. And other than that, I will leave it to our esteemed moderators. If you need me at any point to advance a slide or to move to a different slide, please just let me know that. Say next slide, or could you go back to the previous slide, and I'll be happy to do that. Sarah, quick question, are the questions at the end going to be in the Q&A thing or in the chat thing? Do you know what I mean? Yes, and they will be in the Q&A. Okay, we don't need to worry about answer dismiss. We'll just sort of rotate as Kamala had indicated. Yes, and that's a great point, and thank you for bringing it up, Dr. Lloyd. Please don't dismiss a question because we will be keeping, we're keeping track of those so that, you know, if there are any unanswered questions, we can address them later. Are we allowed to triage them? I mean, I don't want to go one by one if they're all redundant, you know. Absolutely, absolutely. We would expect you to do that. I just mean don't click the dismiss button on the question because that will remove it, and then if you want to go back later, it won't be visible to you. That's all I know. Did your tech guys get a nice opening song or something for this? Pretty big. That was you, Mike. Yeah. You don't want to hear that. Someone just put in the attendee chat box that FYI, everyone joining the meeting can hear your conversation. We are aware. Thank you for letting us know. You're part of the, you're an incredible part of the team as an attendee. So yes, thank you for reminding us. And while we're speaking to the attendees, I will let you know if you have any questions or raised hands, please do save them for the Q&A section. We will be addressing those, the moderators are watching that, but we will be saving that for the question and answer section towards the later part of the webinar. Kamala, I had one more question. Sorry, you probably mentioned that. But during the presentations, do we need to keep our camera on or can we switch it off? You can switch it off. We won't be on screen anyways, right? We won't be on the screen because they'll be sharing. So you know. OK, thanks. I can work on my tie. Sarah, would you mind checking if Andrea is on the video? Yes, he just joined and I just promoted him. Just joined, OK. All right, thanks. So it may take him a moment for us to be able to hear him, but he's on his way. Jeanette, it's over. I'm looking for Andrea. Yes, he's there. Did you load the slides? I mean. You're live. Andrea, can you hear us? You sound a little bit muted. You sound muted. Is your volume on? Yeah. On the computer, though. It's all the way up. I mean. You sound a little bit quiet on the thing. Yeah, I cannot hear you when I don't. No, it's better here. No, but yeah, because I had the phone. Look at how low it is. Turn it up. Ah, I will do it. OK. And then I'll be sharing my screen, so if you want to do the same, I think that might be useful. Oh, you know that. Hold on. All the way up. You guys hear me? Yes, we can hear you. OK, is it better? OK. Because I was. Can I go after you? Because you owe me. Can you go up on the volume, Andrea? I think I'm almost. Is that OK? Like this? How much do you want? No, you're not. OK, I'm the maximum. So can you try to open the slide? I just want to make sure that we have. So they say I cannot start sharing when. So OK, I guess. So do you like to pass that out? I can stop sharing so that you can test that out, Dr. Natale. Can we try? OK, just want to make sure. Let me get my sharing stopped. There you go. OK, so that's OK. OK, perfect. So you can see it, right? Yes. OK, fantastic. Now go back to yours and go stop sharing. So I should have stopped sharing, right? OK, perfect. I will share the general slides. And once the speakers are introduced, I will stop my sharing so that you can put on your slides. Hey, Prash. Hi, Andrea. Thank you. Good to see you. Thank you for joining. Yeah, good to see you. And I see Michael. What about Schmidt? Hey, Boris. Boris here? Yes. Buonasera, signore. Hi, how are you? Xavier? Camera. Hey, Andrea. Is Xavier around? Yes. Xavier is somewhere. Andrea, can you see me? No, I don't. OK, let me see. We've seen you, Andrea. I got it. Good to see you. Just going to say a few things for the attendees. I know we have 90, over 90 people who have joined. If you can just hold on for a second, because it's international platform, we're just giving a little more time for people to join. And thank you for joining us, but please have a little patience. We'll get this going. Jai Radha Kumar Bani to see more people registering or joining us. So I think Sarah, we can get started. All right, thank you very much, everyone. I wanna thank all of our attendees for joining us for today's Pulse Field Ablation webinar. Please note that a recording of today's presentation will be available to all of you through Heart Rhythm 365 shortly on your MyCourses page. So you will have a record of the full webinar. Following the conclusion of today's webinar, please be sure to complete the webinar evaluation and remember to claim your credit for your attendance. If you have any questions outside of our time during the webinar, you can reach out to education at hrsonline.org, and we will be happy to help you. As I mentioned at the start, but I want to make sure everyone hears, if you have questions and would like to raise your hand, we would very much like to address those, but we ask that you save them until we get to the discussion portion of the webinar so that our speakers can complete their presentations before we move into a question and answer mode. Thank you very much. And without further ado, I would like to turn things over to our esteemed moderators. Thank you, Sarah. Welcome, dear colleagues. Today, Heart Rhythm Society, the BEAT, is proud to host our first live webinar on pulse field ablation. This is a free CME event. The disclosures for all the faculty have been shared in the previous slides, and I am Kamala Chamarisa, clinical cardiac electrophysiologist from Texas Cardiac Arrhythmia in Dallas, Texas, United States, and I'm the co-chair of this program. The goal of the webinar today is to provide you with the background, animal and human studies, and practical application of this novel technique that uses electrical pulses to ablate myocardial tissue. We have two esteemed speakers today, followed by an excellent group of panelists, and our two esteemed speakers are Dr. Andrea Natale and Dr. Amin Alamad. Dr. Natale was born and raised in Italy and completed his training in cardiology there. After completing training at the University of Wisconsin and Canada, he joined Duke University's faculty and was the director of EP and section head. He then became the medical director at the Cleveland Clinic's Center for Atrial Fibrillation and was named to the task force for atrial fibrillation at the FDA. Dr. Natale is the recipient of numerous awards and a highly regarded expert in the field of EP. Dr. Natale integrates innovative technologies that advance our field. His attention to detail, patient-centric focus, and use of specialized devices and ablation catheters support advantageous outcomes for our patients. Dr. Natale is currently the executive medical director of Texas Cardiac Arrhythmia Institute in Austin, Texas, United States. In addition, he's an internationally acclaimed academician, clinician, and a passionate researcher at the Institute. Thank you for joining us, Dr. Natale. And our second speaker is Dr. Amin Alamad. Dr. Alamad completed his undergraduate studies in bioengineering at Syracuse University in New York and went on to complete training towards his EP fellowship at Tufts University School of Medicine in Boston. He joined the faculty at the Stanford University School of Medicine for an additional 10 years before he joined Texas Cardiac Arrhythmia. Dr. Alamad was the recipient of several excellence awards in teaching. In addition, he's an avid researcher, author, and co-editor of several books in the field of EP. He's an international speaker. He currently serves on several editorial boards, including Heart Rhythm Journal and the Journal of Interventional Cardiac EP, and also social media editor for the Journal of Circulation, Arrhythmia, and EP. In addition to private practice with Texas Cardiac Arrhythmia, Dr. Alamad continues to be actively involved in a large number of research grants and trials with a special interest in development of new technologies. I know that was a mouthful, a lot of introduction, but these are the esteemed speakers. I couldn't shorten those intros. With that, I am honored to invite my co-chair, Dr. Sanders, to take the platform, and he's joining us from Australia. Thank you, Dr. Temerisa. So I want to add my welcome to this first live webinar from HRS, and it's a esteemed group of speakers, and it's my pleasure to introduce to you the panelists that we have for this session. We have three panelists who are going to help us with the discussion. We first have Dr. Melanie Gunawodna, who is from St. George Hospital in Hamburg and has recently had a tremendous amount of work that she's published in the area of pulse field ablation, and so we're looking forward to hearing on her experience and her input into the discussion. And similarly, Dr. Boris Schmidt, a good friend who's from Frankfurt, again, recently has a large experience in the clinical utility of PFA, and we're looking forward to hearing his experience. And finally, Dr. Javier Sanchez, who's from the Texas Cardiac Arrhythmia Group, and again, with a large exposure to the PFA technology, and we look forward to the discussion that we can stimulate from the speakers today. And with that, I'd like to introduce Michael Lloyd, who's the co-chair of the Digital Education Committee at HRS, and Mike, I'd like you to introduce the social media team. Thank you. Thank you, Prash. Welcome, and I'm excited to be a part of this first and its kind event. I'd like to thank and welcome our social media influencers, Dr. Mihak Dande, Dr. Clint Thurber, and Dr. Merdad Emami for keeping us current and relevant. And with that, I'll hand it over. Thank you, Michael. So just a request to the audience, please use the chat box for Q&A, and with that, we'll hand over the platform to Dr. Amin Allamad, who will give us an overview on electroporation, animals to humans. Okay, thank you so much, Prash and Kamala for the great introduction and for allowing me to share with you and participate in this. I think this is really an area that's very exciting. First and foremost, I want to acknowledge a few people who've been kind enough to share some of their slides and some of their insights, both Jacob and Kamala. So the concept of electroporation is not a new one. In fact, many years ago, when ablation was first starting, when we were doing DC ablation, of course, this was a little before my time, in the mid 80s, applying high energy to try to ablate tissue, there was some electroporation that was ongoing with those types of ablations, but there was also barotrauma going, and this really did not take off very much. There was issues related to flash arcing, which of course is not ideal for anything that we're doing in the heart, but that concept of being able to destroy tissue in that way has existed. It's not a new concept necessarily. Now, so what is electroporation? Well, essentially it's delivering these ultra short, fairly high voltage electrical impulses to the tissue, and in doing that, it changes the electrical field across the cell membrane and creates these nanoscale pores, essentially it porates or opens up the tissue. Now, you can have it either permanent electroporation, which results in cell death, or reversible electroporation, which has utility, for example, to create permeability of the membrane, which allows you to insert things into the tissue, for example, gene therapy or so forth. This is an example for up here, you can see this is a catheter that may deliver electroporation, and you can see here you're delivering a pulse train, and that pulse train is what essentially changes the electric field. In this bottom video that you're seeing here, you can see that as you deliver a pulse train, it porates the cell, so if you have a fluorescent dye, that fluorescent dye can now enter the cell rapidly. So this is all occurring in a matter of just a few seconds. But like everything else, when you have this kind of technology, we need to understand it a little better and understand how it works. And so this diagram is a little bit helpful in that you can see there's an electric field that you can generate based on the voltage that you're giving as well as the pulse width, and there's some other determinants that I'll go through in some detail with you. But as you do that, as you modulate how high of a field you create, you can go from reversible electroporation, which again, the application is to allow something to enter the cells and then have it be reversible so those cells don't die, to irreversible electroporation at a higher amount of energy, to thermal ablation, which is what we're trying to avoid because of the problems with thermal ablation. The good news with this in a lot of ways is that there's tissue selectivity. And so, for example, you can look here and see in this graph how different it is between the myocardium and the nerve. So to electroporate a nerve cell requires a substantially higher electrical field than the myocardium. And that's really important because what that tells you is that you can be fairly tissue-specific with this kind of technology. The other important thing about this is that if it's killing myocardial cells or ablating myocardial cells, you may still be able to keep the tissue scaffolding in place and that may end up being fairly important as well. You can keep the structural integrity. That's very different than thermal burns. It's worth talking about this for a little bit. And so up in this upper corner, you can see the difference of different types of catheters. There's monopolar ablation, which would mean ablation from one of these poles to a surface patch that's considered monopolar or unipolar. Bipolar ablation would be ablating from one pole to the other. And so you can deliver electroporation either monopolar or bipolar. Now, the other thing you can do is deliver these pulses that you see. They can also be monophasic, meaning they're all either above the line or below the line, either a positive voltage or a negative voltage, or they can be biphasic as you see here in the diagram where some of these pulses are positive and some of these pulses are negative. You can vary the amplitude of the pulse. You can vary from hundreds to thousands of volts. And so you can see here in this lower diagram, there's the A, B, C. The A is the amplitude of the pulse. The pulse width is the B. The time between the two pulses is C. So all of this can be modulated. And if you get into even more detail, you can see that the actual pulse, the rise time, the amount of ringing, the type of decay that occurs, all of this can be changed. So you can modulate all this. And what I'm really trying to tell you with this is that there's so many different iterations of this. In other words, you can have a device that delivers a certain type of pulses and a different device that delivers a different type of pulses, whether the number of devices in a train is different, the number of pulses in a train is different, the voltage may be different, the pulse width may be. All of these things are things that can be modulated and changed. And therefore, all of these devices are essentially very different devices from the perspective of the basic engineering of the device. Now, they're all supposed to do the same thing, but they can be very different. It's also worth mentioning that the device is really tailored to the delivery system. So your delivery system is tested with that pulse train. You can't necessarily add a new pulse train to a different delivery system without testing it. These are just some of the things that may be modulated. And of course, as I mentioned, the different types of devices will have different recipes, if you will, for their particular electroporation. And now when we perform electroporation, we're essentially performing what we now call pulse field ablation or pulse field electroporation. In other words, you're giving some pulses and that creates an electric field and that creates the electroporation. These are some of the different catheters that are out there at the current time. These are either in development or have undergone clinical studies. And I think Dr. Natale will mention some of these and potentially talk about some of the results related to them. I'm really going to focus a little bit more on some of the animal work and some of the safety aspects of these more than that. Here's an example of this device. This, I believe, is the Boston Scientific device. You can see here in the panel, the pulmonary vein potential. And with delivery of these pulses, the pulmonary vein potential goes away. Now, it's probably one of the most important messages with electroporation is that the electrical effect is greater than the cellular effect, meaning that you may see diminution or elimination of the electrogram before you actually reach cell death. And that can fool us a little bit because when the electrogram's gone, you know, it doesn't mean that you're done, in other words. Now, it's been tested pretty extensively for safety. This is a really elegant experiment that was done by Jacob Kruth and the group at Mount Sinai, where they essentially tried for a worst-case scenario. They actually took a esophageal deviation device, pushed the esophagus up against the inferior vena cava in animals, delivered radiofrequency, and delivered biphasic PFA. And they were aggressive with this in order to try to see as much damage as they could. And in the animals, all four of the animals that they tested in this particular study developed mucosal problems whereas zero of the animals studied with electroporation developed that. That's very encouraging from the perspective of it's possible that the field doesn't go that far or that the tissue type is different enough that it's not selective to esophageal tissue type. This is another example of what you will see with electroporation. You'll see that the vessels are well-preserved. There's no significant damage to the vessels. You'll see that the nerves also, the particular areas that we worry about like the phrenic nerve are damaged. And you can see that the lesion demarcation is really quite beautiful. It's really nice and clean. If you try to get pulmonary vein stenosis with the device, you can test this versus RF with PFA essentially zero pulmonary vein stenosis being shown. This is a summary slide of the Medtronic device, all of the different types of testing they've done. Just looking here at the pulmonary vein stenosis, you can see if you deliver irrigated RF in an animal model, you can clearly get pulmonary vein stenosis with fairly aggressive pulse field ablation. You don't see that. You will not see thermal effects. You will not see any other significant effects. So it appears to be fairly safe. If you look at how well the lesions look, they're fairly well demarcated. And you can see here really nice fibrous tissue that develops when you look at this histologically with the arterioles looking fantastic. Here's another example. This is in an animal, right atrial appendage. You can see how clearly demarcated the lesion is. And you're able to deliver some pretty big lesions with this. An example of radiofrequency versus PFA and the kinds of things we've seen for years with radiofrequency, where you can see within the lesion areas of hemorrhage and thrombosis, whereas with PFA, it's fairly homogeneous fibrosis and the blood vessels remain patent. Here, you can see that the arteriole becomes remodeled. The wall becomes thickened, whereas here really looks completely normal. And then lastly, you can get lipogranulomatous inflammation with RF, where you would not see that with PFA. Pulse field ablation directed essentially right on top of the nerve, really does not seem to affect the nerve again, primarily because the threshold for damage for the nerve is substantially higher than the threshold for damage for the heart. There's a couple other new catheters that are in development. This particular catheter can deliver both RF and PFA. And so you can modulate what you wanna do, which is interesting because for example, if you want to deliver radiofrequency in certain parts of the heart, you can. And if you wanna deliver PFA in other parts of the heart, for example, the posterior wall, you can do that. And again, the types of lesions you're seeing here are pretty impressive. You can see with RF, the typical kinds of things you'll see, the necrosis, the hemorrhage, whereas with PFA, really nice, clean fibrosis. This is just a video of that particular catheter and how you can, within really a matter of just a second or so, deliver this pulse and then move the catheter on. A lattice ablation catheter, a larger ablation catheter is also in development. This one can be placed within the pulmonary vein and ablate pretty quickly as well. And all of these essentially have iterations of the same thing where you'll be able to place the catheter in the thoracic vein that you're interested in, the pulmonary vein you're interested in, rotate, ablate, rotate, ablate, and so forth. The last thing, this is kind of an interesting slide. There is some signal that perhaps being close to a coronary artery might pose some risk, although I think we're still trying to understand this a little bit more and a little bit better in terms of how close do you need to be. Of course, a lot of these studies are worst case scenario studies and whether there's ways to mitigate that type of risk. So I'll summarize a little bit. With electroporation, the electric field is what determines the lesion. The catheter tip and pulse design are unique. Every catheter tip and pulse design have been married together so that it's optimized. Contact is important. You don't have to have a lot of force, but you do have to have contact. And then repetition of dose is important. It turns out that just because the signal disappears, it doesn't mean that you've created a lesion. Limitations of the lesion creation, the electrical effect is greater than cell death effect, meaning again, the electrical effect, you lose the signals quickly, but that doesn't mean that you have created cell death. And that means there's a recipe for doing this, which we're learning with part of these clinical studies. Durability assessment is difficult. Acute assessment is difficult in the sense that once the signal is gone, it may not return. And if there is, if it does return, it may return later. So one of the things we need to learn about this is overall durability. You will not have any steam pops char. The lesions are fairly quick. High quality or strong contact is not needed. You do need contact though. It does not appear that because there's no char, you won't have diminution of energy delivery. And it may be easier to ablate intracavitary structures. Some of the things we don't know, can you control the seat lesion size, shape and direction? Can we titrate this to effect? That's not entirely clear. How can you tell when a lesion is complete? Again, because you lose the electrical signal, the electrical information, you may not be able to necessarily know. Are we at risk for inadvertent ablation areas that are important like the sinus node, AV node? What's the risk of coronary spasm? Is there any risk of phrenic nerve injury in humans? And then what about parahysian type work that we have to do? Will this be too easy? Are the catheters going to just create a lot of ablation? How is it gonna work in scarred myocardium? And then what if there's metal objects around like ICD stents and we're very close to them with our delivery, what will the effect be on these objects? And then lastly, in the ventricle, will there be induction of arrhythmias? So with this, I'd like to thank you for your attention and I will stop sharing my screen. And I know Dr. Natale will move on to discuss some of the more clinical issues with this and some of the experience with humans. Wow, thank you very much, Dr. Alamai. That was fantastic preclinical overview. And with that background, next is Dr. Natale speaking on the types of PFA, its clinical experience and some of the clinical nuances. Dr. Natale. Okay, can you hear me? We can hear you. Great. So great introduction. I mean, this is my disclosure. So Amin already talked about the biophyses. The one thing that I want to mention is this. Amin said that. So in the device that we're using today that we're gonna mention, those parameters that Amin mentioned, the waveform, the peak voltage are all different. And those have a significant, they can have some impact on the outcome. And this is something that we learn in the initial clinical experience. Some of the feature are known to us and some are not. For example, the duration of the train, some of the variable that Amin mentioned, they are not necessarily known to us. What we know is the peak voltage, which as I mentioned is different in some of the technology that we use, but really the detail of the waveform that is used to deliver are not necessarily known to us at this point. And certainly that's something that's gonna change once all those devices are gonna be FDA approved. And so, but those are clearly important variable as it is important, the design of the catheter. So, and this is something that Amin mentioned. Also, and I'll show you some clinical data, monophasic and biphasic do generate different type of lesion. If you use a single point catheter, we kind of learn that the biphasic lesion are very superficial where monophasic are deeper. And the same probably is true when you use a single short catheter with multiple electrodes. Those are three of the four, I'll show you a picture of three of the four catheters that are now undergoing FDA ID trial. The A and B already have finished enrollment and they are very close to the one-year follow-up. C just finished enrollment the last month. So now I have to go through the one-year follow-up required by the FDA. Whereas the B catheter is very close to the end of the one-year follow-up that I think it should be close to around January, February next year. Whereas with the catheter in A, the end of the one-year follow-up should be around May. And then hopefully after the submission, they will become available to us. The catheter in A was tested in a randomized, a large randomized study in paroxysmal patient. And a single arm persistent study should start in US soon. The catheter in B was a single arm in both paroxysmal and persistent. Whereas the catheter in C was a randomized study in persistent, randomized to RF contact force. And I mean, showed this before. This is kind of give you the difference in the footprint of the area that we cover between the single point that we're used to today in this catheter. And this is an example. So this is sort of a single point, but with a larger footprint. And one things we learn, I think this is very relevant for us, not too much for audio operator, but clearly with this PFA, we need to really sort of stack up lesion on top of each other. Otherwise, even if the electrogram disappear, otherwise those are all area of potential reconnection and recurrence. So what you see here is that as we move, those lesion are really on top of each other. We don't have to worry about as with radiofrequency energy, that if we're close to the software stacking up lesion, it can be actually dangerous. This is something actually, we tell people don't stack up lesion when you're close to the software because you don't give time to cool. So you increase the chance of a social problem. With this catheter, there is no issue. And we actually, in some of the early human tests in Europe, we actually measured the temperature in the software. We've done some endoscopy and we never saw any issue. So, I mean, already mentioned that. I think the safety of this device, I mean, I'll show you some human result, but the safety, it's really, I think, something that make this technology very exciting. Many of the issue that we dealt with in the last 20 year are gonna go away once this become available to us. And I think this is exciting from a safety point of view, especially for the patient. I mean, I already showed you, so I'm not gonna spend time. This is actually, that was an animal. This is actually inpatient. It's an MRI study showing that when you look at late enhancement and compare cryo to radiofrequency and PFA, both the cryo and the radiofrequency show some enhancement around the esophagus, which is not instead visible inpatient undergoing electroporation ablation. This is another catheter that also just finish last month enrollment in USID, single arm non-randomizing paroxysmal. This is actually the name, the study that I was part of in Europe that I think now is very close to getting CE market. And this is some example of deletion. It's kind of a loop, large catheter that was slightly redesigned. I don't know who of you were involved when this catheter was used with radiofrequency energy. That approach was abandoned because of some cases of esophageal fistula in Europe. Obviously with PFA, we don't have to worry about that. So this is a, I mean, mention this. I want to show, look at the electrogram gone with a single application. That does not means, that does not means that the lesion is done and you can move away. We learn that, and this is actually part of the protocol that we need to apply multiple lesion. And I think one of the things that I mean mentioned that contact is important. We don't have to have good contact but we need to be in contact. And the way we now overcome the inability to know contact especially with a single shock catheter is to try to deliver more lesion and to rotate the catheter reposition around the area of interest. So this is a study that we did and we've done many of these in Europe with early human testing, showing that the amount of esophageal temperature increase as we deliver in front of the esophagus is really dismal. And in fact, we've never seen any issue so far. I mean, already show this is in animal but I'll show the same in patient. This is from Vivek showing that the dimension of the pulmonary vein before and after the ablation remain unchanged overall. So also in clinical study, this has shown to be safe. All the FDA, they have sub-study to look at this issue and also another one that I'll mention later which is the potential risk of asymptomatic stroke. And as you see in this early report of Vivek that the complication rate are more related to the procedure rather than to the ablation. So there is no pulmonary vein stenosis, there is no esophageal systole, there is no pericarditis, which actually we tend to see with RF especially after extensive ablation in at least 20, 25% of the patient. So those are all things that are gonna go away. Obviously stroke are possible because you have still catheter inside the cardiac chamber. I think in U.S. where uninterrupted procedure is more popular, that would become less likely. But also we need to remember that some of these catheter have a large sheet. So managing those sheet in term of potential air embolism is important from the point of view of embolic event. Obviously vascular access is a procedural problem but for those of you, and I think this is becoming standard everywhere in the world that use vascular access with guided by ultrasound, I think this is gonna become also a rare issue. This is some early experience from Vivek showing what Amin mentioned inpatient, how important is the wafer in the way you deliver ME. So clearly monophasic was not a good option because they had a reconnection rate similar, maybe even worse than current, actually for sure, worse than current radiofrequency energy technology. But once they moved to biphasic and optimized the biphasic, look at the reconnection with a single procedure went up to the upper 80 and 90%. So this is certainly encouraging results. One of the things that I wanted to mention in our experience with high power short duration after we optimize the recipe, the most common area of reconnection is the area where we deliver on tissue facing the software. We see 91% of the reconnection that we see in our lab are in those area facing the software. So clearly, and the variable that sort of is different because the power is kept the same is the duration because of this temperature increase, the duration in those area is five point something second versus more than 10 in the other. So all of this is gonna go away with pulse field abrasion. In fact, this is a recent paper from Vivek showing posterior wall isolation that was durable in nearly 95% of the patient with a single procedure. So those are all exciting things for our field because certainly we make this procedure less operator dependent and also less dependent on the variable that they affected the RF because of the proximity of the software, for example. This is the early human experience that is on the publication with the Aferacat that I mean, show you, and I showed you before this is the lattice mesh. And what you see here is similar to what I show you with the Farrapulse, where the waveform affected the persistence of the lesion. And as there was optimized, that improved. So you see that with the Pulse-1 there was a 50% reconnection around the PV and then with Pulse-2 became 87. And then with the Pulse-3, which is the one that we're using now during, with the use now in the study in US, it was 97%. So clearly the waveform is extremely important by keeping the design of the catheter the same. Sorry. The same is true for linear region. You see that all linear lesion and the roof line are improved from a 63 with Pulse-1 to 100% with the Pulse-3 in the roof. And overall with all the other linear lesion which include also the mitral, we're around 91%. So very encouraging data that are going to be relevant. This is the success rate. Success rate, I think we had to measure this in the real world because those are all procedure done by experience operator. Also, there is some patient selection to potentially can affect the outcome but clearly you see that both in paroxysmal and persistent very similar results, so they're certainly encouraging. And this is instead with the Medtronic device that probably would be the first to obtain FDA approval in US. This is the result from the feasibility that were published. So there is no patient outcome. It's more about the lesion duration, procedural duration. And you see that those number are certainly on the shorter side and what we're used to currently with the current technology. I mean, mentioned about SVC, this is an example of SVC delivery without affecting Frenninger function. Another things that I want to mention is that with some of the technology that we use, especially with cryo in the balloon and some of the other balloon technology, we learned that the chronic effect, although the acute effect looks more antral, but we learned that the chronic effect is actually really an osteoisolation. This is very different than what we see, obviously with RF and with pulse field ablation, you see that the chronic lesion are more antral. So I think that the effect around the border is actually more permanent than acute, as we have seen clearly with cryo and in general with the balloon technology. This is actually a case of a PFA application in the persistent lesion of urinary achaemia that our group and other have published as an important target when present. So a patient with a persistent lesion of urinary achaemia, if you don't target that anatomical variation, those people usually tend not to do well. And here you see a case where the PFA catheter was delivered in the persistent lesion of urinary achaemia and ablated to treat this patient. Here you see, again, a series from Boris, actually is on this with the complication that, as I mentioned, they are mostly procedural related. So confirming the safety of this approach. And again, from Boris, a learning curve that is achieved in about 20, 25 cases and then remains stable over time. So clearly we are talking about very quick learning curve with good chronic efficacy so far. This is a large registry that was published recently in Europe. First author Vivek, but many contributed to this is 1,700 patient. Showing again that the complication, obviously are mostly procedurally related. So you see that the vascular complication, pericardial effusion and stroke, TIA, all the stuff that we worry about with the radiofrequencies of a GI fistula, PV stenosis, a frenular paralysis, they are not there. There is some case of transient frenular, but so far it seems most of these were recovered pretty quickly. So we're dealing with complication that are more procedurally related. As I mentioned before, for those who use it uninterrupted, stroke and TIA become less of an issue. And I think pericardial tamponade also, for the U.S. center, they use intracardiac echoguided transeptal are less likely to happen. The source of tamponade these days are the transeptal axis, a steampop. With the intracardiac echo, that become less of an issue. Issue obviously with PFA, there is no steampop. So I think this procedure can become extremely safe from the patient perspective. One issue obviously is embolic event. Obviously, I already mentioned that one reason could be the fact that you're doing a procedure stopping the blood thinner. Another one could be with large sheath, large air embolism. But one problem that we've seen with RF and we have been investigating with also PFA is what we call microbubble generated by the energy delivery that are detected as you see here with transclinical doper during the procedure. This is an example of such cases. So we just finished a study in Europe with the group in Brussels. And I think you will see probably some abstract related to that. I think the result are reassuring. So although we'll continue to expand this series, we look at comparing in the study RF cryo and PFA and look at MRI. So I think it would be an interesting study to look at the result. But I can tell you that so far this does not seems to be an issue. The amount of microbubbles that we see with PFA can be different from the different device and the way from the user. So this is important, but so far doesn't seems to be a major issue. This is the experience that the team in Austin and you see here compared to a match control with RF. So clearly if you look at the PFA time and this is not just the pulmonary vein we had done a procedural wall. So we go from nine to 60 minutes. That's certainly impressive even in our lab. I mean, mention about this issue. This is a case of a spasm during ablation along the mitral isthmus. And here you see again the same the same during ablation with the flower cap along the right side, the right isthmus. DIVEC has done a study that just came out. I think the implication are important. So you look at this, the coronary spasm after PV and procedural wall versus application in the right atrial isthmus. I'm gonna go through this quickly because I wanna show you. So here, you know, a picture of the spasm. Here you see the catheter in the right isthmus. And let's go to here. So what they saw is they never saw spasm during PV ablation and procedural wall ablation. So what we do for a typical procedure is safe. When ablation was done in the cavity of the isthmus there was, if you see here, there was spasm in five of the patient where energy was delivered without administration of nitroglycerin and it was severe. However, and this is important, in none of these patients spasm was associated with the ECG manifestation. So there was no ST elevation, okay? But when nitroglycerin was administered then there was no evidence of severe spasm. Most of the spasm were mild and in one case, moderate. So this is something I think is, we have to learn and understand a little better. But overall, the fact that with a pre-administration of nitroglycerin that can be reduced. And also the fact that it was subclinical because without doing the angiogram actually there was no ST elevation, also reassuring. So, but I'll show you a case that was, this is actually a case from one of our ex-fellows that now is in Europe. So this is a UCPFA application. And then you start seeing a little bit of ST elevation in the inferior lid. And then more ST elevation with some PVC, then more ST elevation by germinal PVC. And then eventually the patient went to EF. By the time, then very quickly it was cardioverted. And you see that right after cardioversion, the ST is sort of normalized. And by the time the intervention came and did the angiogram, the coronary artery are completely normal. You see that the RCA, and here you see the LAD, they're completely normal. So clearly this is a spasm. This is not the type of effect that we see with RF, where there is a narrowing that actually need to be dilated when you deliver RF close to a coronary artery. This is really the effect of a coronary spasm that very quickly resolve spontaneously. So I'll stop here saying that the adoption of this new non-thermal energy for RF ablation pulse filabration has the potential to significantly reduce procedural duration, improve lesion durability, although here we are the caveat of the design of the system and the waveform use. But, and more importantly for our field, they completely eliminate the risk of collateral tissue damage. Obviously, as Amin mentioned, the efficacy could change based on the device design and the waveform used to deliver the energy. Thank you very much. Thank you, Andre. I'm gonna remind everyone to post their questions in the Q&A section so that we can post this to the speakers. And I want to now bring out the panelists to kind of get their view on the presentations, but also from their own experiences using these techniques. So Boris, you've got a large experience from Europe. Would you like to make some comment on this? Yeah, thank you, Prash. Hello, everybody. So to give you a perspective, we have used the Ferropulse system in a clinical setting. And in the past approximately 18 months, we've treated close to 500 patients using that system. What did we see? So we can basically confirm what the two speakers have presented. So it certainly speeded up our procedures, accelerated our procedures. So we have observed skin-to-skin procedure times as low as 20 minutes sometimes. So the average procedure time is below 40 minutes in our lab with, I think, eight operators having used the system. So that's certainly a factor that will have a major impact in the field. In terms of safety, I can also confirm what the speaker said. We haven't seen any issues with the esophagus. We haven't seen a major side effects except for transient phrenic nerve palsies. Maybe we can discuss the mechanism later on though. So when delivering energy to the right veins, we sometimes see a weakening of the right hemidiaphragm, which usually resolves within seconds, sometimes minutes. And we haven't seen a patient leaving the table with weak contraction of the right hemidiaphragm. So certainly a functional problem. And I think there's also bench data confirming that there's no structural harm to the nerve. What else? We have also published our data on remapping in patients with repeat procedures. So patients coming back with various types of arrhythmias after an index PVI using this PFA system. And what we see is an enormous durability of the lesion. So in 91% of the remap veins, the veins were completely isolated. That is for us, it's a major step forward. So whenever you are targeting a region, obviously the lesions remain durable. And I think Andrea also referred to this other system, the Affera system and showed some data on durability of also linear lesions that seem to be very durable too. So that's really great. What else? The spasm, maybe the spasm. Yeah, that is certainly one thing that deserves further exploration. We actually had one case of spasm after ablation of the right superior pulmonary vein. So this is a little bit in contrast to what Vivek and coworkers published. So it might happen rarely. Maybe it's a completely different mechanism. I don't know. It's not a mechanism that is related to distance, but maybe to a massive release or increase in vagal tone because we're working on the GPs, right? So that is at least a mechanism that is well-known in the field of interventional cardiology. And yeah, I'd like to hear your opinion on that, whether this may, this particular side effect of this energy may limit its applicability to certain regions in the heart. Especially Andrea likes to address more than just the PV region, especially in persistent AF patients. And that may be a limitation. I don't know. It could be an interesting point of discussion. Great. Melanie, can I switch over to you because you published probably the first case on the spasms. So it's kind of an important prelude to some of the discussion we're gonna have. So do you wanna talk about your experience and particularly maybe enhance on the spasm side as well? Of course, sure. Thank you very much. So yeah, it's true. We were, I think the first ones who observed it and we were kind of surprised because obviously the first moment we didn't think it was a spasm, right? Because we were told that there was no collateral damage. So we thought it's air embolism because of the big sheet. And it's also something you need to know also when talking about silent thumb embolisms and everything that the sheet is very large and that you need to manage your air. So that was our first thought. We thought there was air, so we waited for a bit but then we realized that ST elevations that presented in a patient didn't disappear. So we got curious and we waited like nothing happened. And so, yeah, we did an angiogram on the patient and we saw the spasm and then we applied nitro and it disappeared completely. And I agree with Boris. I think so far, all the data that has been published and the workup that Vivek Reddy has done on the topic shows that they don't seem to be so harmful. Like they disappear quickly with nitro. But I think still we are talking about a really new energy source that we have not that much experience of, for example, compared to RF, where so many of hundreds of thousands of patients have been treated. And now we have a small number of patients and we've seen it in a few of them. And also I think it was really impressive what Dr. Natala presented where the patient went into ventricular fibrillation. And I think this is harmful for a patient. So maybe the spasm itself isn't, but what it can cause as this delay and VF. And this is something electrophysiologists that use that technology need to know. And at the moment we're using it at high center and experience centers, but it's a technology that's supposed to be easy and that we wanna bring in the broad field of electrophysiologists. So I think this is really something that we need to consider and think a little bit about before moving forward. Great. Dr. Sanchez, would you like to make some comments about your experience as well? You're on mute, so please unmute yourself first. Perfect. Yes, my experience has been very limited, but I'm certainly very excited watching the field. I wanted to ask Dr. Schmidt, in your lab, since you have it available for all cases, are you doing it for all cases with PFA? Yeah, that's a good question. No, actually, no. First of all, I never believed in monopolies, so I wanna keep a little bit of variability in the lab, but that's not a scientific answer, of course. I don't think that currently there's data that shows that PFA, let's say, is superior in terms of long-term outcome. Certainly it accelerates the procedure and et cetera, but I don't think that all thermal energies forms or devices should be abandoned immediately until we see those results, if they come. The second thing, of course, is that we also are talking about economical constraints. So this is a new technology, and it's certainly more expensive for us, in Germany, at least. So we also need to consider these points, and that's why we still do ablation with thermal energy sources. Yeah, I wanna mention exactly what Boris said is very important. I wanna explain this because I think the people in US, they don't necessarily understand the difference. In Europe, the DRG is different in every country. Germany has the best DRG in Europe for ablation. Like here, for example, in Italy, the DRG vary between 3,500 euro, 3,500 and 5,500 euro. So this device in US are now sold for $8,000. I think in euros is way less than that, but even if it's 4,000 euro, that's very close to the entire DRG value. So I think that is gonna be something that is gonna sort of slow, beside what obviously Boris said about, we need to understand better long-term result if really there is a big difference, but just the economic of this new technology, I think it sort of slow down moving to 100% use of PFA because that kind of pretty much, at least I can tell you in Italy, it would break the bank in most center because the DRG is that the hospital get paid is lower than the actual cost right now, the device. So I think that's an important consideration. Camilla. Yeah, no, great point. Some just learning along with everyone else. So a couple of questions, probably I'll give this to Boris. What do you think about contact force and mapping and utilization with PFA? And this is from one of the audience. There's no discussion on the various PFA solutions providing contact sensing capability and can you comment on various vendors with regards to that? You know, I think what Amin mentioned, the contact is important and the way we overcome that problem is by delivering more than one, I would say in our lab, more than one or twice or three times, all the device require at least two application in the same position. We usually tend to do more and move the counter in different position. So right now, that's all we have. The next generation, many company are already working about surrogate of contact or actual contact information in the next generation device. So this is gonna change, but probably it will take another couple of years before we see it. Right now, the best we can do is to just do more application. One thing that we have been exploring is using imaging. So using eyes, for example, to actually make sure that we are in a good position that could help. But that's a potential limitation, especially with the single-shot device that have multiple electrodes to actually control contact across the entire system. Cutting is difficult. And so the best way we can do is to try to reapply in different positions so that we cover the therapy well. Melanie, I see your hand up. So comments, please. Yes, thank you very much. I just wanted to add something. I think it's a really interesting point with the eyes because what we've seen when we started using PFA is that we found acute reconnections and it was in a superior veins. And I think Boris also published it in his remapping data in Europace. And we didn't find anything about this in the early experience. And maybe that's because eyes was used. This is one of the explanations I have in the US trials. And in Germany, it's not reimbursed. We don't use it. And the device tends to turn posteriorly because it's an over-the-via device. And also you have to make sure that the catheter is self-centered. And you can't, like, if you open it up too wide or press it too much, you might not get the proper and homogenous electrical field. So I think this is a really interesting point. And I also agree. I think we need some image integration maybe if we don't have eyes. That's just my comment. Thanks. Amin, you want to make a comment? Yeah, I agree completely with the comment about eyes. We were utilizing eyes extensively during some of the clinical studies that we did to make sure we had good contact. And I agree with Andrea that, you know, it doesn't seem to be a penalty for sort of, you know, doing a little bit more in particular in areas that are critical like the pulmonary veins. I think that one of the other answers may come in the future with the integration with mapping systems. I think the technology will exist where once you have full integration of these systems with mapping systems, the proximity of the catheter to the tissue might be detectable and might have some help. The last thing I want to say is I think that the efficacy safety thing are two sides of the same coin. It's like what Andrea showed us that when we look at our recurrences, they're next to the esophagus. We're unable to deliver. It's not that the risk of esophageal fistula is so high. It's just that you can't deliver good therapy there because you're limited by your fear of that. And you can't find that sweet spot. You blight too much, you have a fistula, you blight too little, you get ineffective. How do you find the right spot? And so I think this is one of the big potentials for this. And of course we need to understand the durability of this therapy. Yeah, I wanted to add that to what Tamim mentioned about the integration with the mapping because actually the variable system come integrated with the three-dimensional mapping system. And actually we see the lesion on the three-dimensional map so that we can actually decide if there is an area where we don't see overlapping of the dots and deliver more energy. So the three-dimensional mapping is another way. It's not going to give us contact, it doesn't now, but at least we can look at the lesion deployment and make sure that they overlap and they cover properly that area. And there are cases where we have done additional, just based on what we've seen on the two-dimensional mapping system. Boris, you had a question. Yeah, it's more a comment than a question. Just let's say specifically adding on the question towards contact force. I think the point is made, the importance of contact force with PFA is certainly much less than with RF. It's more about proximity. So you need to be close to tissue because the electrical field will be unchanged. It would always be the same regardless of the tissue that is nearby or not. And if you're close enough, you will be transmural. And I think there's nice work done by Hiroshi with the point catheter and the galaxy system, PFA system, that shows that if you have contact force of 10 grams, that is certainly, well, or if you go beyond 10 grams, let's put it this way, you won't get additional depths to your lesion, at least when you do point ablation. And I totally agree with everybody that integration into a 3D mapping could help, but as of now, at least using the PFA system, Ferropulse, the 3D mapping integration is still not perfect because usually when you deliver energy, the whole map disappears and you don't see anything for, let's say, seconds. And you need to wait until everything is recalibrated and you can see your catheter back. And I think that's a little better done with the Ferro system, as far as I saw from the life case at Rio, right? And also with the J&J, you actually see that in real time. So you kind of see the overlapping of the lesion. So yeah, otherwise with the Ferropulse right now, that's a problem, yeah. Especially if you use the Abbott system, everything kind of goes beyond. So we have a question about really workflow. Now, how are people doing these cases? Is it under conscious sedation? Is it under general anesthetic? I mean, I think this is kind of important questions as people start to use this. Do you each want to make a comment on that? Andrea? There will be probably a difference between, I know I've been done cases in Europe. In Europe, anesthesia is more relaxed. In US, so far we've done all cases under general anesthesia. I think it's kind of more an expectation here from the patient. They don't want to feel anything. So that even those little muscle twitch that they're going to feel if they're awake, I think you're going to be a problem in our patient population. But I think in Europe, Boris can talk about their protocol. They've done this even with the RF. So I'm sure that they are doing many of these cases without, right Boris? Yeah, right, right. So we are in the luxury situation in Germany that we ourselves can apply propofol. And so we don't need the anesthetist in the room. And it's not a legal issue as it is in other countries, even in Europe. So, yeah, and it works. I mean, even with deep sedation, usually applying between let's say 30 and 40 milligrams of propofol per hour and adding some energetics like fentanyl, that works. And you can do the procedures without, let's say, bad memories of the patient to do that procedure. It's not very different from thermal energy procedures. Melanie, are you doing anything different there? Oh, we use the same cooking recipe as Boris Schmidt. So it works. What you have to know when you use it is that the patient might be moving a bit more. This is something you need to consider. And also they cough after ablation of the left superior vein. So also something you need to consider because you kind of have to wait. It's not really getting better with more sedation. So the patient's coughing and you would think you need to apply deeper sedation, but I think it's just the effect of the ablation and you have to wait a moment for it to disappear. And then on the right side, while you ablate, you can have phrenic nerve capture. So there's a lot of movement going on, which you're not used to in the beginning, but after a little learning curve, it's usually fine. And the patients, we talk to all of them, they don't remember. And I think that Karsten Eben presented at a German conference also, people, patients describe less chest pain and like pericarditis like symptoms and things because it's so sensitive to the myocardium. Yeah, so far we haven't. Actually, that's a good comment because we pre-treat all our RF patient with Colchicine. And then, you know, if they don't have problem, we stop it after, and they want to have some chest discomfort, we continue. With PFA, we haven't done that and patient don't feel anything the next day. So it's certainly, that's another added benefit to this technology. Great, I know we talked about the atrial tissue. Any experience in ventricular tissue and PFA amongst any of the panelists? I have done a few cases in Europe with the single point catheter. I think we need more experience. I think the nice, and the nice things about this technology is that, I think we mentioned that multiple application of the same site increase the depth. And I've seen lesion that go from nine to 16 millimeter in ventricular myocardium in, you know, this is all preclinical testing. So I think that's exciting because that means that we don't need to go in the epicardium anymore and maybe do a better job with minimally myocardial scar with this approach without using, you know, bipolar or, you know, all this other sort of technology. But I mean, that's something that is gonna happen for sure. That's actually fantastic comment, Andrea. And I'm also really, I was surprised to see the depths of those lesions, but I'm a little worried to be honest with you about the width. If you look at the animal data and that Eli Hunter and his group published, I mean, those lesions are up to 2.5 centimeters wide. And if you're working in a human ventricle that is not enlarged, you could damage a lot of the surrounding tissue. Are you, would you, are you afraid of this? No, this is Boris. That's a very good comment. I think we're gonna have to be very sort of selective the way we apply this. Part of that is probably device dependent because it was with the lattice catheter, but I think, you know, you're, that's something that totally we're gonna have to be aware. So if you're in the middle of a scarifying, when you're at the border, you have to certainly worry about that. Absolutely. Dr. Sanchez, you know, you're a master ablationist. I mean, you ablate like a very high volume operator. As in someone standing outside, what do you think of the PFA, just the future, when compared to the RF and the cryo? Just comments. I think that what Dr. Smith was saying, that not using it for everybody, that the expense is gonna be something that limits, that you cannot do, at least it doesn't seem like it's easy to do an AVN or deablation in the same procedure or to go after an atrial tachycardia in the same procedure with the same equipment, that I don't think radiofrequency is gonna go. We keep emphasizing the idea that the procedure is faster, but like Andrea was saying, we already do the cases in an hour for a paroxysmal normal heart, an hour and 90 minutes. In terms of safety, the idea that one doesn't have to worry about the esophagus, that for sure would be nice. Like Amin alluded to, it's really not a common problem. As a matter of fact, we've gone now several years without seeing it, but the worry is constant. The phone call a week later when the patient gets a little bit of fever. So I think if the price is right, it's certainly gonna be used. I don't think radiofrequency is gonna go away, but it for sure is very exciting. I've been reading lately also, I wanted to see what the other panel is, the idea that it doesn't seem to affect the autonomic system as much. I take that as a positive, right? So I'm curious to see if you think that that would change the success rate from the ablation. That's a good point. Yeah, I think we still have to understand a little better if more extensive might be different. I think we're done maybe a little more than other and we've seen some change, at least for a few days, not as long as you see with RF, but I'm not a big supporter of the additive effect of gangrene. In fact, most of the surgeon that we know in our area that actually do a good job, that they completely abandon ablating the gangrene during surgical procedure. We did a study when I was in Cleveland with a tool that Atul published, showing that even if you suppress all the gangrene with RF, the patient still have recurrence. So I'm not sort of worried about this effect at all. I have to say that to me, the safety is, I want to mention this because with amine, we did a case with amine coming from a different state that had two previous procedure. And this young woman had stenosis of two veins. One was completely occluded. They could not dilate it. The other one was dilated. And when we did the procedure, we saw that the stent was sticking out in the left atrium that much. So this is a young woman that's life has changed because of this. Even if it's rare, in our end, it's not happened. Those are things that I think are gonna go away. And I think there will be a great things for both us as doctor, as you said, the phone call a few weeks after with the fever and for the patients more importantly. So, even if it's rare, those are things that affect people life forever. And I think it's gonna be great that they're gonna be gone. Yeah, I may mention about that case. That case, unfortunate lady, that complication would not exist if they had used PFA, if it was available. But the flip side of that is also that young lady ended up having an SVC trigger, which was not recognized. And so even with PFA, we still have to be electrophysiologists. It's not just fast ablate and get out. I think we still have to give this some thought and continue to understand what we're doing. And it's not just fast ablation and leave. So I think all of those, and like Javier said, if you have an atrial attack, you're gonna chase it, so. Andrea, can I ask you a question? So you've presented multiple different catheter types here. Are they all going to be equal in what they achieve, unlikely? Now, in terms of coronary spasm, we're kind of being told that's generic to the energy, but could it be partly the catheter as well? You've used most of these, so. Yeah, I think the answer to the efficacy is no. We learn that every catheter have sort of different issue. Some of them has to do with the peak voltage and some of that with the catheter design. So I think people are gonna learn about different efficacy with different catheter that relate to the design of the catheter, but also to the waveform, both in terms of peak voltage and other characteristics. In terms of spasm, I have to say that both in the case I've done in Europe and in US, we've been kind of limited because we're all sort of either early in humans, so we're kind of sticking. So I never use those catheter in the sort of unusual area. But I have to say, we did linear lesion, as you have seen, including the right atrial isthmus, and we haven't seen it. But said that, remember that Vivek was doing angiogram, but none of those patients in Vivek's study show ST elevation. Despite, if you look at the coronary angiogram, it was a pretty remarkable spasm. So I don't know if the jury's out. And I think now we all feel that is probably pulse field ablation in general, the electroporation in general that can do that. We need to learn. So with other system, we deliver in the same area, but we haven't seen, but we were not doing angiogram. So I don't know if I can completely say that it's gonna be less of an issue. Okay. Melanie, I think your hand is up. Yes, thank you. Just a comment on this, because we are talking about different catheters and waveforms. And if it's true that different waveforms pretend patients from maybe an adverse outcome or a safety issue, I think it would be necessary for us doctors to actually understand what the recipe is. Dr. Ahmad showed it very nicely, how we can incorporate different parameters in the generator to create it. And now we're having this magic tool that is fast and easy to apply. But there's different things out there. There will be more things coming. And I think it is interesting for us to understand more about what is the difference between those waveforms and what does it do to our patients. Boris, I think you wanted to add something to it. Yeah, thanks. I would love to pose a question to the other panelists and speakers. So the one device that was presented allows toggling between PFA and RF energy. And I just wanted to hear your perspective on why would I use RF or in which scenarios did you toggle? Do you like that feature or is it just because it's there, you use it? What are the clinical scenarios to apply that? Yeah, so I'll start answering because I've used it. So when we started using in Europe, it was RF in the anterior segment and PFA in the posterior that are facing the solar. Then we moved to just totally PFA because that's where the field was moving. I think one thing that we have seen with RF, I show you the linear lesion. They're both remarkable. With RF, clearly in the area that are problematic with the single point, we achieve really almost 100% permanent block. So I think that's an option that can become valuable in certain patient like hypertrophic cardiomyopathy where clearly that area is way thicker than the average patient. And maybe most of the PFA may not be enough. I think we need to learn about this. So I think, I don't know for sure, but I think that there will be some specific patient where that option can become valuable in the situation where the tissue is unusually thicker. So that, but, you know, that's a speculation right now. Yeah. Eleni. Yes, I, oh, sorry. I have a question in regards to this. So Dr. Natala, do you think this is because you would actually need more PFA at those thicker tissues and we're not delivering enough. And there's some regression of the lesion because we have a zone of maybe only not irreversible but reversible electroporation. And this is something we also don't know yet which like the size of lesion is gonna end up. Yeah, so if you look at it, that, yeah, this is exactly. So if you look at what most of the PFA we're using in the atrium, they have sort of a depth that is about five millimeter. Five millimeter is probably okay for most patient but there are cases, and the reason why I mentioned hypertrophic cardiomyopathy those are people where certainly that can go beyond that, especially in the area of the isthmus. So we've seen in some time the amount of the appendages. So they are exceptional case of where the tissue is gonna be thicker. And some of these device are calibrated to achieve a depth that doesn't necessarily reach that sort of exceptional thickness. Obviously, as these device evolve, we mentioned in the ventricle lesion that goes nine millimeter to even 16, I've seen that can be a new point. But I'm talking about the current device that we're using now could have that limitation. Yeah. Boris, anything to add to that or you ask the question? So Michael, any other questions for the panelists? I know they spend so much time with us. I really liked the point of the varying pulse waveforms and duty cycles, how that's the great mystery of this technology. And until we are enlightened as to what variables can change, I think for me, that's gonna really accelerate it. I would like to ask everybody, how different is one versus the other? Is there any sense? I know these are proprietary, but how different are these waveforms? Well, Michael, right now what we know is the peak voltage and it is different in the technology. The waveform is a mystery because we're totally blind. So that's the part that I think we eventually, we would like to know because I think it's important for us to understand how they impact. Certainly the peak voltage we have experienced that can be a factor. And that's certainly different from the technology we've been using, but it's not just that. So, and the waveform right now is totally obscure to us. That was a wonderful session. And I think we are getting close to, we went more than 75 minutes. So I appreciate everyone's time. Thank you everyone. Thank you everyone. Incredible faculty for your time and expert comments and our social media influencers. You don't know that they're sharing everything on LinkedIn and Twitter and our audience. Thank you for joining us. I know it's in the middle of the day here in United States and elsewhere. The time is not perfect, but appreciate that. And HRS leadership and the staff, thank you for your support and happy holidays, everyone. Thank you. Thank you, bye. Thank you very much. Bye-bye. Thank you everyone and attendees. Just a reminder, please do complete your evaluation and claim your credit for attending this webinar. If anyone needs any help, you can reach out to our CME team at CME at hrsonline.org. Thank you all very much for your time today on behalf of HRS. Thank you all. Bye everyone. Bye, thank you. Bye-bye. Thanks, Sarah. Bye-bye. Bye, thank you all very much. Bye, thank you. Bye, Melanie. Thank you.
Video Summary
In this video summary, experts discuss a new energy source called pulse field ablation (PFA). PFA is a non-thermal energy that uses high-voltage, short-duration electrical fields to create a transmural lesion. The experts explain that PFA can be used as an alternative to radiofrequency (RF) ablation for treating arrhythmias, such as atrial fibrillation. They note that PFA has several advantages over RF ablation, including shorter procedure times, improved lesion durability, and a lower risk of collateral tissue damage. The experts also discuss the use of various catheters and waveforms in PFA, noting that different devices may have different efficacy and safety profiles. They emphasize the importance of good catheter-tissue contact for optimal lesion formation and mention the potential role of imaging techniques in guiding PFA procedures. The panelists also address concerns about coronary spasm as a potential side effect of PFA and explain that more research is needed to fully understand and manage this issue. Overall, the experts are optimistic about the future of PFA and believe it has the potential to significantly improve the safety and efficacy of ablation procedures for cardiac arrhythmias.
Keywords
pulse field ablation
energy source
non-thermal energy
high-voltage
short-duration electrical fields
transmural lesion
radiofrequency ablation
arrhythmias
atrial fibrillation
procedure times
lesion durability
collateral tissue damage
catheters
waveforms
efficacy
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