Welcome to everybody. I'm Frank Marchlinsky from the University of Pennsylvania, and we're here at a very special session that's entitled Revolt Against the Ordinary, the Latest in Pulse-Field Ablation. And our first speaker is a doctor, Professor Helmut Puerl-Feldner, hope I didn't pronounce it too badly. I'm glad. From Ordense Clinicum in Linz, Austria. And he's gonna tell us about early volt PFA system experience with Abbott Balloon in-basket PFA catheter. Thank you, thank you. Dear colleagues, ladies and gentlemen, welcome. Good afternoon. I'm European. I'm based in Linz, Austria, Europe, not Australia, Austria. And I have the privilege to talk about my pulsed field ablation experience with the Volt AF system. And so this is the initial European experience in the CE mark study. And then when we received the CE mark, so now the catheter is readily available in Europe, we are now doing a bit more than the PVI. We're trying to do, to extend both the workflow, but also the use in different patients, the substrates that we find there. And I'm gonna tell you something about what we do now. How can I move forward? I hope this works, no. And that works. So just to make a long story short, this is the catheter, the Volt PFA catheter. It has eight splines equally spaced at 45 degrees, acting as electrodes and allow the Ansite XP system to know the location of each spline, which is very, very important, I think. And we have an active portion of the spline, excuse me. OK, we have an active portion of the spline, as you can see here, where PFE energy is delivered from the highlighted section of the spline and one long 17.5 millimeter flat active electrode per spline, eight splines. And we have two magnetic sensors, two shaft sensors allowing for six degrees of freedom visualization. And the distal sensor allows for accurate rendering and location in the N-site XP system. We have shown the data of the six month results at ERA, European Hard Rhythm Congress, in Vienna one month ago. And it is remarkable, to be honest, because the six month effectiveness for paroxysmal atrial fibrillation is 88.2% freedom from documented AFL and AT, and 76.7% for persistent AF. This was 150 patients. Two thirds were paroxysmal. One third was persistent atrial fibrillation. Acute efficacy, 99%. First pass isolation, 97%. And in some of the patients, we did redos after three months of the blanking period. And in the remap, 93.3% of veins were durably isolated. That is a high percentage. So that shows that we are doing durable lesions with this system. Regarding safety, there was no hemolysis or kidney injury reported, no phrenic injury, thermal esophageal lesions, no stenosis, no spasm, and a 2.7% of primary adverse event rate, two vascular events, one tamponade, one pneumonia. And interestingly, because this was done in Europe and in Australia, 37.7% of cases, so more than a third, was done under conscious sedation or deep sedation. Myself, I'm using propofol in combination with midazolam and fentanyl, and that works nicely. Also for this catheter, very nicely, I have to say. And the reason of this is that this catheter, and I will show that to you in more detail, kind of concentrates and directs the energy by this ballooning basket design to the tissue and is isolating the current to other areas like the blood and really directs it to the tissue so that there is little muscle recruitment, so very little movements of the patient. And there is little effect on blood cells. And this now is a patient after the study where we were forced to just do PBI for atrial fibrillation. This is a patient 63 years with the first ablation more than 14 years ago and was scheduled for a redo procedure, having arterial hypertension and some ACE inhibitor-induced cough, hypercholesterolemia. And the interesting thing was this patient has five pulmonary veins with a roof vein close to the right superior pulmonary vein. And this is now in my lab, myself doing the procedure with a fellow on my right. You see the BART system. You see now the NSAID-X system and the fluoro. And I start in such patients with a single sheath catheter technique in the left atrium and do the map with the grid catheter. And we saw that there were some focal re-isolations in this patient. However, the voltage was quite normal, except that there was this roof vein on the posterior wall that was more or less going to the middle so that if we would have done just the isolation of the veins, there might have been a very small rim which might have then induced some atrial tachycardia. And this vein was conducting. You can see it. You can appreciate it here, this roof vein. And so I decided to do, in addition to the re-ablation of the veins, also the posterior wall in this patient. And what you can see here is this LivePoint software where you can see in blue when you are in good contact with the tissue and in white when there is acceptable contact. And you see the sliding bars telling you in which poles you are more or less to the tissue when it comes closer to the outer ring or when you're more away. And you can select electrodes for ablation. And then you deliver energy. You see this kind of percentage. And when you have 100%, then the energy delivery of PFA stops. And so this is the left superior pulmonary vein. And because of having this consistent spacing of these eight electrodes, you can predict the site where you ablate, the contact by impedance measurement. And by this, you can also, and this is called E-field rendering, you can predict the electrical field and also whether this lesion will be durable when it reaches more than 400 volts per square centimeter at the given point or not. And according to this, you get this white or even blue fields. Blue meaning that there will be an effect of a durable lesion based on the prediction because of this stable electrodes that allow you to kind of predict the electrical field. So that is interesting. And that is very rewarding, I would say. And now we are treating the veins, as you can see. And then in the next part, I was treating the posterior wall. And in this posterior wall, I first used the wire into the vein in order to be close to the circumference of the vein. But then when you go a bit more to the wall itself, to the posterior wall, I retracted the wire and just did the steering with this large agility sheath that we have available. And I'm quite used to agility sheaths. I use them every day. And that was very easy to really then get into contact with the posterior wall with three, four, five electrodes. And the other ones were deselected. And you can really nicely then isolate the posterior wall and have a real good contact. And it goes smoothly without any wiring. So you can really use just the catheter handling and the sheath. I did it in this case because of this right superior pulmonary vein in order not to have any kind of gap in a very small rim. I do not ablate based also on studies that we publish. So as a summary and a takeaway, and you can see on the left here the voltage before ablation and then afterwards. And down you see this electrical field, E-field integration. This E-field projection is precise and provides an additional level of confirmation of energy delivery. And also that you can predict the lesion in its durability. The option to individually select or deselect electrodes and splines is highly beneficial for customizing therapy. Lifepoint display is effective in ensuring. and of effective tissues, minimizing the risk and enhancing patient outcomes. So that was our case, and I hope you enjoyed it. I did it. Thank you. moment. I have a few just to start. We'll get the audience warmed up here. We're waiting for them to stand up and ask some questions. But you indicated that when you did the posterior wall, you basically were able to pull the wire back and then guide the mapping and ablation with the agility sheath. Yes. Did you also use the catheter handling? Because it's also bidirectional. You could do, especially if you think that the sheath might not steer in the way you would love to. But I'm very used to this sheath, although it's a large sheath. Of course, it's a 13 French. But you could also retract the sheath and just have the catheter in, and you would still have the handling of the catheter doing this posterior wall. So you can do it both. Now, as a standard, did you use a medium curve agilis? Yeah. That's the standard. And you didn't size it with small atria, larger atria? If it's very small, I would take a small sheath. But normally, I take a medium sheath. And for VTs, I take a long sheath. So small is normally rare, I have to say. But the problem, as you say, Frank, is if the left atrium is very small, then it can be a challenge, especially for the right inferior pulmonary veins. And you would have to puncture a bit more anteriorly. But for the posterior wall, that was not a problem, really. Very good. And so this is a single axis, a single sheath? Single sheath in the left atrium, and a CS catheter that I routinely use. But in the left atrium, you just have a single sheath. And you use the HD grid to map the... To map. Always, when I do a redo or a persistent AF, in a paroxysmal hour lens workflow, where I am now, is to map on the fly. That means I have to CT, and I go in with a balloon and map on the fly when I enter the veins. I don't do any additional mapping before, because I only do PVI and paroxysmal atrial fibrillation. So that's according to standard and to the guidelines. So people have talked about how the outcome that people normally experience when using other types of PFA systems is a little bit more limited, and the outcome after six months a year, closer to the mid-70s in terms of recurrences. Yeah. That is something we recognized. It's a bit higher. Yes. And so do you think it's because the degree of contact that you're able to achieve consistently is not questioned, because it's basically easy to get the balloon in? I think the balloon helps you. The balloon helps you in the basket to be more stable, and the balloon also enables the electrodes to have the same distance from each other, which also then helps you to predict the field strength. So this kind of steady and predictable distance is very, very important in this way, as it is important for the great catheter also. Have you noticed that you have to deselect some electrodes in certain positions more than in others? To be honest, I don't care to be honest, but you don't hear that. It's between us. I'm kidding. For routine PVI, I don't deselect electrodes. For the postural wall, yes. You deselect. So then the other question is, do you find, do you need to deflate and reinflate or it's just one inflation? It's an inflation of 10 cc, nine with saline and one with contrast, after preparing the balloon. And if there is a small vein, I take out two to three milliliters to deflate to seven milliliters. That is the minimum. Then it's easier to reach the right inferior, for example, right inferior pulmonary vein, some inferior branch of the left inferior, something like that. We do that sometimes. Is that needed also when you're on the posterior wall, a little bit, or it does not matter? No, no, no, no, no, no, no, it's not. It looks like you have two balloon applications in the vein, each vein, on average, or is it more than that? What is it? What we saw is the minimum is two. Okay. But I think it's, it's better and we can show this by the results. The 12 month results will be presented tomorrow and there will be some, some hint on that. It's better to do three to five. We normally do now four applications, two more ostril and two a bit more antral. Four applications per vein makes sense. But that's still a minimum number of applications. Then you get, you get 16. Yeah. And then if you do the posterior wall, it's 20 or 22 application. It's not that much. Yeah. And so the hemolysis risk should be. Should be very, and is very, very low. Very good. Also the second thing is the muscle recruitment is, is very minor. One last thing, the predictability. So you had an opportunity to bring few people back and. Yeah. 90% were isolated. Yeah. In that 10% was the threshold reach during the ablation that indicated that they probably would be successful or was it borderline or uncertain? Yeah. We, we didn't do the analysis now. Didn't do the analysis. I'm not aware about that. Yeah. I'm not aware. It was 90% so it's not many that were. No, no. It's not many. Very good. Also the, the, the rate of, of. Very good, so this is really great any questions I don't see any questions here on the iPad, but please feel free to put in some questions I mean in summary you know now that we're gonna What do you think is the take home? that is outstanding. And the way that we can, by the precise location of these electrodes and the stable positioning, we can predict the effect. That is. I'm here, on your back. Just a much more technical question. When you pull the catheter back in the posterior wall, you do just one application? You rotate the device? I rotate. I do around four to six applications on the posterior wall. First start doing it a bit more central with the wire, then retract the wire, and then do it free in the rest of the posterior wall. So three, four additional on the posterior wall, in the center of the posterior wall. Just one or two transseptal punctures? One. So you exchange? First the HDGrid, and then you pull the HDGrid out? Yes, exactly. First I do the puncture with a smaller sheath, so a Gillies 8 or 9 French with a long needle, and then I exchange to the 13 French, and then it's this sheath in with catheters to be exchanged. Or if I do it in the first two PVI, I don't do any mapping. I do it on the fly with the balloon. So there is no grid in. Well, if there are no other questions, I want to thank you for an outstanding presentation. And we'll move on to the next speaker. Okay, let's move on to the second speaker. So I invite Monica Lau. I think this is the FlexPulse IDE clinical case, so we are just eager to have your insight into this new catheter, and obviously, please, Monica. Thanks for having me, and I'm going to share a case from the FlexPulse IDE trial. Of note, this catheter is currently not commercially available, and so this is, again, a case from the trial. So TectaFlex PFA system, the catheter name is TectaFlex Dual, and it's basically the same catheter handling as the TectaFlex, except it has an added insulation to the ring electrode so that it's updated for PFA compatibility. During the PFA, it's basically connected to the volt generator, which is the same generator that you can use for the volt balloon, and it's delivering the PF in a monopolar fashion. And when you want to switch over to RF, which is the advantage of this catheter, so two systems in one, you can connect it to the Ampere generator to deliver RF. In the study, we did have to change the cables, and you'll see that it doesn't take very long to do that, and hopefully with commercial use, it will be a single cabling system with a user interface to switch between the two. And what is great about this technology is that it's integrated with the InsightX mapping system. So as you know, InsightX can support many different PFA platforms, and for this system, we delivered the lesions point-by-point fashion, and it is very accurate, the most accurate map that I've seen, using basically a similar workflow as high power, short duration. So with the mapping system, you can see contact, contact force, lesion assessment, and also lesion tracking. So the two studies that looked at TactiFlex Dual is FocalFlex in Europe and Australia, as well as FlexPulse IDE trial here in the U.S. and some sites in Europe. Both are prospective, non-randomized, single arm, multi-center, worldwide clinical investigations with a fair number of subjects included. The objective is to demonstrate safety and effectiveness of the TactiFlex PFA system. The follow-up period is 12 months. Enrollment is currently closed on both sites, but the follow-up is ongoing. And again, the advantage is a dual modality of PF and RF, and the PF application basically applies five-second lesions, and currently the design is adequate for a transmural lesion in the atrial tissue. And as you can see on the left-hand panel that it is a linear point-by-point fashion, you can see contact force. The ablation is very precise, so it's not a large area ablation. And it's designed to basically, well, I guess European colleagues may say it differently, but to minimize skeletal muscle recruitment. And my workflow is to use GA in the study. So in PF and RF, PF delivery creates a deeper lesion more quickly. So with a five-second application, it can achieve a mean depth of 6.8 millimeters, and compared to RF, at 50 watts and 60 seconds, it provides similar depth. However, you can stack deletion, so if you apply three at the same spot, then you can achieve deeper depth, and this can be explored more. It's designed to minimize thermal and micro bubble safety, and when we switch over to RF, it's used to basically, you can titrate the power around the conduction system, and also around coronary arteries to prevent spasm. And we really use this to our advantage in rolling patients in the trial. Sometimes the patients have atrial flutter, and sometimes SVT that is either expected or unexpected, and with one single catheter, you can deliver PF safely on the posterior wall to minimize any risk of esophageal injury, on the right side to minimize any risk of phrenic nerve injury, and then both sides to minimize pulmonary stenosis, but when you're close to a conduction system, or if you want to do a mitral isthmus line, you can certainly very quickly switch over to RF. So as Dr. Verma said yesterday at the summit, it's very important to have a catheter that demonstrates contact. I think that all the second generation catheter or future PFA systems need to demonstrate contact, but how much contact, and is the contact force necessary? So in this SWINE model, it shows that axial force correlates better with increasing depth and lateral force. So when you deliver energy parallel to the tissue, it correlates better than delivering energy perpendicular to it. And in this model, it shows that greater than five grams really doesn't offer additional advantage when predicting the lesions, but you do want to achieve around five grams. So this is our experience at Arkansas Heart Hospital. In doing the trial, we have 40 enrollments between two investigators. There were two screen fails, and we enrolled in the sub-study that looked at hemolysis and micro-bubbles, so getting labs pre-imposed ablation, getting a brain MRI pre-imposed ablation. There's a high first pass isolation rate, just like we saw with the TectiFlex catheter in RF. It's a very powerful catheter. We had first pass isolation 36 out of 38 patients. The LA dual time was mean of 77 minutes, floor time of 2.5 minutes. And during the PF ablation, we did use the irrigation volume at 13, mils, just because that was what was studied in the animal model, so the irrigation volume was slightly higher than what we typically see with TectiFlex RF ablation. The total PFA treatment, we applied 94 lesions mean. So this is a case. Patient's a 56-year-old man with hypertension, hyperlipidemia. He complains of palpitations and heart racing. His monitor showed paroxysmal atrial fibrillation and short episodes of SVT. He was placed on metoprolol and flecainide. He felt fatigued on the metoprolol and he was still having breakthrough symptoms. His echo was normal EF and normal LA size. He was referred for pulmonary vein isolation. And my workflow is, again, general anesthesia, and I followed my workflow for TectiFlex, which is two transeptals, the mapping catheter through SO1 and the ablation catheter through the normal size, eight and a half inch agility. And you can see that first we use HD grid for mapping. In the study, we weren't allowed to use the HD grid X, but HD grid, both catheters are very, it's my favorite mapping catheter tool. As you can see that people, we can very easily go into different branchings of the pulmonary vein with this catheter that's very easily maneuverable. And I get a pre-procedure CT to basically look at the anatomy of the left atrium. So after the mapping, we're ready for ablation, and I have eyes and you can see that it's, again, a five second delivery and the pulses that's delivering. On the left side, before the left side ablation, I do empirically give glyco for vagal response. And again, it's designed to minimize any micro bubbles. The color, the lesion colors are light blue for five to 10 grams and dark blue for more than 10 grams. And average force of less than five is white. You can see on the electrograms that just like the TactiFlex catheter, they're great signals on the electrograms. And that's the advantage. I think some said that it was PVI only to don't even care about electrograms, but I do look at electrograms. And sometimes in the enteral region, the ridge sometimes can be a little bit slippery, but the advantage of the TactiFlex catheter is that it provides a stability. In this case, greater than five gram was a little bit harder achieve on the lower veins. And sometimes I wonder if it's from the irrigation volume, but that really needs to be further investigated. So after the isolation, I bring the gram back and that demonstrated exit block. So during this study, we were asked to not deliver PFA. Within two centimeters from the grid catheter to prevent arcing. So I actually leave one mapping catheter on the other side, but virtually when I come back to map it, we achieve first pass isolation very easily. And we move on to the right side of veins. So pacing, checking for phrenic was recommended, but not required. And from the vault experience, I really did not find any phrenic nerve to be an issue. So I did not check for phrenic nerve pacings. And the patients, even though they were under general anesthesia, they were not paralyzed. Very rarely did they have muscle recruitment, but it did not interfere with their workflow or the respiration meter. So it was very, it was not a problem at all. And again, just going through delivering the lesion. It is point by point, it's kissing lesion. So one next to the other, not overlapping lesions. And these are four millimeters. And again, afterwards, when we come back and check for entrance block virtually, we achieve first pass isolation. And we do have to wait per the study protocol 20 minutes, just to make sure that there's no reconnection. However, that I guess was more leftover from the previous RF protocol. So this is a pre and post PVI voltage MAC. And you can see that instead of kind of blasting the entire left atrium, it's a very discreet, elegant, precise ablation. And this minimizes any sort of possible isthmus that could occur to possibly induce some atypical flutters. So this was actually a surprise in this case, because we were pacing to see if we can induce any arrhythmias. And then with the LV pacing, we actually saw eccentric retrograde atrial conduction. So we were glad that I had this catheter as an option for RF ablation. So doing this time, it did not take very long, maybe 10 seconds or so to switch over modality from PF to RF. And since we had the mapping catheter in, we map and delivered PF to eliminate the accessory pathway. So I know that we're not supposed to talk about timing and procedure time or whatnot, but I do want to demonstrate that even though this was not a single shot system, the system is very powerful in the sense that it delivers lesions very accurately. So this procedure start time was 6.51 a.m. Transceptal heparin given at 6.58. The ablation catheter in the body at 7.04 and total PF ablation time was 29 minutes with 84 lesions applied. LA dwell time was 68 minutes with a 20 minute wait period per the study protocol. And we started RF at 8.09 and with a total of 60 second RF time. The irrigation volume was a little over 500 mils and the total procedure time was 82 minutes, again, including the 20 minute wait period. So even though this was a point by point ablation, again, it's a powerful catheter, a very elegant catheter that was able to achieve isolation very easily. So the TactiFlex PFA system, TactiFlex dual offers both PF and RF, and it gives you the flexibility in case of different arrhythmia types, and also we selected patients with they have atrial flutter, creating a CTI line. I did not show that, but we've had cases where we do PF on the left and then come back to the right and do a CTI line with RF. And also it's very user friendly for those who are not used to using large bore sheets. So it doesn't affect the workflow and the workflow is similar to high power, short duration with precise lesion sets. As you can see that the catheter gives you clear electrograms and signals and importantly, it gives you contact information to ensure that you're delivering adequate lesion. Thanks for your attention. Thank you. Thank you. Thank you, Monica. Is there any question, any comment from the audience? Yes, we don't have any questions from the iPads. Okay, Monica, I think that you demonstrated that point by point is not dead yet. So I think that it's, you know, good news. And I don't know, you know, what is your reaction, you know, by using the PFA system by using the PFA with the different catheter design and point by point. But I find probably, and I like just to have your comment, that probably is much, you know, are useful for a redo procedure. And I like just the comment that probably if you predicted patient, you know, might have a maybe a typical etroflatus or etrotachycardia, you might go with the, you know, point by point and just, you know, to be much more effective than use, you know, using maybe just a large footprint catheter or, you know, a balloon design catheter with the PFA. Yeah, I agree. We also were involved in the vault as well as single shot. So I think it's patient selection. The important thing is the contact information knowing that feedback, right? And then based on patient history, what kind of arrhythmias they have, if it's PVI only, then maybe the vault system may be easier for some. But again, some users are not used to large bore sheets if they're more, I think that it's easier to go from a point by point user switch over to vault personally than the other way around. Like if they use cryo balloon, they will gravitate towards vault. But the TectiFlex tool gives you that advantage of treating different arrhythmias, not having to worry about spasm or close to the AV node. If you ever use the PFA on top of a ref, just one of the cases that you have done, maybe just in some, you know, anatomic location that you need just to, let's see, be more effective in terms of, you know, depth of the lesion. Yeah, so in this study, I mean, I don't have experience with that just because of the study protocol. We weren't really able to do that. But to your point that that's where the catheter can come in even, you know, later on studying for ventricular arrhythmias or whatnot, stacking them. So actually we do have a couple of questions. So we'll start with Monica. So one question is, somebody's wondering whether you can turn on the PF and just drag. They wanna go even faster. They don't wanna have to go on off. So not per the study protocol. And that was because I do drag when I do RF tectaflex. So that was a little bit of a change in my delivery, but it's, you know, five seconds doesn't take very long. And so for Volt, I tell them when it's on, I say blast. And for this catheter, I say pulse. So I'm like pulse, pulse, pulse, pulse. But maybe that's just a part of the workflow that we have to kind of figure out, but I don't drag. Somebody's wondering why you didn't use PFA for the accessory pathway? Because it's part of a study and they're not allowed to use that. And then another question for Helmut. Do you foresee that you can use the Volt without fluoroscopy, without X-ray? If you use ice, yes, we don't use ice as we don't do it routinely in Europe. Then of course I will have fluoro. But with ice, yes, you can, because you nicely see this catheter. And especially in your lab, I think you're doing almost everything without fluoro. So I think you can do, yeah. Monica, can I ask you, how do you think about it then if you have now option of Volt, option of the dual tachyflex catheter, how would you select your patients and what do you think about the importance of depth of the energy delivery? Because most areas of the pulmonary veins, you know, even if you talk about the septum or you talk about the ridge, really just need to get to where there's a fibrous interface and you have blocks. So it's probably still that five millimeters is going to be adequate. So what are your thoughts? I think so for paroxysmal AFib only, I think I will probably end up going with Volt. But if they have a either redo or known flutter or arrhythmia so it's based on patient history, I think is having that tool to, and I'm sure we will come up with protocols to very elegantly, you know, isolate posterior wall with Volt or whatnot, but having both the option of RF and PF, I think it's great if somebody has known SVT or possible another arrhythmia, we don't have to worry about giving nitro and, you know, high doses, whatnot, so. Okay, I think with no further questions, we'll move on to our next speaker. It's my honor to introduce Dr. Atul Verma, who was also my senior fellow at the Cleveland Clinic. And now he's the chairman of cardiology at McGill. And as everybody knows, Atul now is really the expert in PFA and the energy and how it's applied and all the different cycles that it has to go through and recipes. So he's going to talk to us about progress in lesion creation with PFA. That was a very generous introduction. Thank you, Osama. So, you know, yesterday at the PFA summit, you saw no fewer than 1,000 different tools for PFA. And so people have got to start asking, what on earth am I going to choose? And then there's also gonna be people who you're gonna approach and say, all right, well, you know what? Why don't you try this new PFA system? And they're gonna say, well, no, thanks, I've already got PFA. So all PFA is not the same. Second generation PFA is certainly gonna be better than first generation PFA. And it's about putting all of those elements together. That's really key. So what do we need to progress in PFA lesion creation? And we have to understand the importance of contact. Contact is not binary. You just can't have a light that goes on that says, oh, you're in contact and then a light goes off and you're not in contact. You need a non-binary assessment of contact. You don't necessarily need contact force. And we'll get back to that a little bit because I really liked that data, Monica, that you showed that once you're above about 10 grams or so, it doesn't really matter. So that's really the key point. You need the ability to direct energy to those regions with better contact. You need to minimize hemolysis, musculoskeletal stimulation. And most importantly, we need to be able to break that threshold of tissue depth because up until now, all of the PFA offerings have basically offered you the same tissue depth as radiofrequency and cryo. So what's so nice about this balloon in basket design is that first of all, by inflating the balloon, you are pushing the splines against the tissue. And by pushing it towards the tissue, you are preferentially delivering that energy into the tissue and not anywhere else that you don't want to deliver it to. One area is the blood. The other area is incidental muscle mass that is surrounding the heart and that gives you musculoskeletal stimulation. And so by pushing that field outwards, you're not only getting more depth, more contiguity in the lesion within the tissue, but you're minimizing those side effects of musculoskeletal stimulation, and in particular, hemolysis. So hemolysis is not really something you can easily program around with pulse sequences. I mean, you can do a little bit, but at the end of the day, it's how much energy the catheter dumps back into the bloodstream. And if the splines are insulated by a, you know, silicone balloon or whatever it's made of, then essentially, that energy is not being dumped back into the blood. And that's why the hemolysis profile of the Volt Balloon is so favorable. So you look at this graph or these graphs, the left-hand side represents human experience, the right-hand side represents preclinical experience. But look at that, I mean, when you have the variable loop and the pentaspline with an average number of applications, which is about 50, you're already way crossing that 500 milligrams per liter limit where your haptoglobin is exhausted, hemoglobin starts pouring into the bloodstream, and it starts pouring into the tubules of the kidney causing renal damage. On the other hand, look at the eight-spline balloon, which in this case is Volt. So at around whatever it is, 20 applications, which would be the average for a case, you're not even getting close to that hemolytic threshold. And then on top of that, you can go 2X, 3X, I mean, you can go all the way up to 64 applications with the Volt Balloon, which is way overdosing. I mean, at that point, you probably don't have much of an atrium left. But the point is, you're not getting anywhere close to that 500 milligram per liter limit. Non-binary force is so important. And what do I mean by that? So yeah, on the surface, the splines are black or white or blue. So they give you a certain guidance that, okay, I'm in okay contact, I'm in better contact. But what I love are the little lines that are bouncing up and down. So in effect, you're getting the raw impedance data, and you can see how close you are to that white turning blue threshold. And that allows you as a clinician to make a judgment. Because sometimes you know that you're not in perfect contact, but I'm in okay contact. How close to that blue-white threshold am I? And that allows you to actually put your thinking cap back on and start making decisions as a clinician. And then being able to turn off and on splines. So you saw in that session yesterday at the PFA Summit that there are a lot of balloon designs out there. A lot of people are going with that kind of form factor, but you can't necessarily turn off any of the splines because of the way that the energy is being delivered. And then furthermore, some of those balloons don't have any insulatory coating on the inside. So just imagine how much hemolysis that they're causing. So I love the fact that you can turn on and off the splines. As you said, you can go on the posterior wall and not get tons of hemolysis because you're directing all of that energy to the splines that are in contact and none of the energy to the splines that are not in contact. Five millimeters is really the minimum standard that we have to have today. And if you look at the published data on the PFA systems that are out there right now, they're all in that four, four and a half, five. They'll say under exceptional circumstances, we can go to six, we can go to seven. But they're really around four, four and a half millimeters. Five is the new gold standard. When you have to be above that, you can't be any less than that. I'm not going to spend a lot of time on all the different pulse parameters that you can tweak in order to get the perfect recipe. But it's hard. It's really, really hard. PFA is very idiosyncratic. So you'll get something perfectly right. And then you'll say, well, let's just tweak this to make it a little bit better. And then suddenly it's perfectly wrong. It's really, really challenging. So when you have certain companies that have rush, rush, rush, rush, rush, rush, rush, let's get to market really quickly, you get screw-ups that are happening and you get strokes that are happening and you get recalls that are happening. So it's worth taking the little bit of extra time to think it through and to do it right. So in terms of the tacti-flex, I mean, just look at how much thought was put into these considerations. And everything that you do is a little bit of a tradeoff. So how do you find the right magic formula? And the point here is just to show that pulse width, which is a very important driver of any PFA system, even small fractional changes by one decimal point in the pulse width can make a huge difference in terms of the amount of tissue depth. So you can go here from a mediocre tissue depth of about 3.8 millimeters all the way up to a pretty decent tissue depth of almost 6 millimeters just by tweaking the different aspects of the pulse width. But at the same time, let's say you try and go to the higher end of the pulse width in order to get more tissue depth, you're now going to encounter problems with musculoskeletal stimulation. And so where do you put that balance point? Because if you want to be able to do these procedures without paralytics, without general anesthesia, it'd be nice if you had a formula. And by the way, the tacti-flex does have a sort of high-dose formula but also a low-dose formula that's more optimized perhaps for conscious sedation. Heating is very, very important. All PFA systems do cause a little bit of a thermal profile, but there are ways to work around that. So you can adjust things like the interphase delay, the inter-train delay, or the post-delivery delay to try and minimize that heat signature. You can use also higher frequency pulses. So by breaking up longer pulses into higher frequency pulses, you can also avoid that temperature stacking effect and therefore get a lower thermal profile. And you can also use irrigation, although what I always say is you can use a little bit of irrigation, but you should not be dependent on irrigation to remove your thermal profile. So if someone tells you that they're irrigating at 40, 50, 60 cc's per minute, and trust me it's still PFA, don't trust them. It's thermal energy. It's not PFA. Well, okay, it's PFA, it's, anyway, I won't go into that. It's thermal. So I think that as you start to come to that waveform parameter where you're maximizing depth, you're minimizing the amount of musculoskeletal stimulation, next you have to minimize that thermal burden. Pick the formula that gives you the least amount of thermal burden. If you want to mitigate it by four, five x safety margin with a little bit of irrigation, I think that's totally appropriate. If you're dependent on irrigation, you're out to lunch. And then finally, micro-bubbles. Micro-bubbles are basically a thermal signature. So if you're doing PFA, and you're seeing micro-bubbles routinely every single time you do PFA, then you're delivering a thermal signature which is not good for your patients. So the only acceptable amount of micro-bubbles with PFA is no micro-bubbles. That's the bottom line, none, none. So when you have a system on the left where one delivery basically causes a snow globe of micro-bubbles, and that's an approved system by the way, and on the right-hand side you have another system where you have absolutely no micro-bubbles other than irrigation through the sheath, which one are you going to pick? Well unless you're a collector of snow globes, I think I'm picking the right-hand one, and I don't want to cause strokes in my patient. Now what about a medium-sized form factor catheter that also could potentially do high-density mapping? I think Monica, you said the grid was your absolutely favorite tool for mapping. Well wouldn't it be nice if you were mapping and then you were like, oh there's something interesting and then just boom, you get rid of it at the same time with one catheter. So this is really a very intriguing concept, and you can still get contact feedback. So this is just very raw data here. This is not what it's actually going to potentially look like in the future, but I love looking at raw data. I actually wouldn't mind getting this display over anything that looks nicer, but I'm weird that way. But you can tell when you're not in contact or when you're in partial contact or when you're in contact, even with a spline form factor system. And you'd say, but yeah, but you can't use that for PVI. Actually it's a great PVI tool. It's a fantastic PVI tool. You can easily manipulate it either directly around the PVs or you can go into the PV and retroflex and then place it along the antrum. And you can do it with far fewer applications and far fewer maneuvers than other medium-sized form factor catheters like spheres, for example. But this is where it really gets interesting because with one application, you're getting five millimeters of depth. With two applications around six, and with three applications around seven, and all of you are like, oh yeah, that's great. That's interesting. I'm super bored. But then all of a sudden, like with three, eight, and 12 applications, you're getting 11 millimeters of depth and you're like, what? Now you're excited. Because just imagine you're mapping the ventricle, you're mapping the scar, you're mapping the substrate for VT. And then as soon as you find something interesting, you're like, I'd like to go 11 millimeters deep in order to get transmural here. And that's actually very, very intriguing. That's very, very exciting. So you need non-binary assessments of contact force. You need the ability to direct energy to those regions with better contact. You have to minimize complications like hemolysis and musculoskeletal stimulation. You need to create deeper, more durable lesions. And you need a tool set. You need a tool set of single-shot tools, medium-shot tools, and small-shot tools. And if you get the right combination of tool set, you're going to win over the competition. Thanks very much. That was great. That was absolutely great, Atul. Thank you. And you can see why he's the expert on this, because he likes these raw data things. He's weird like that. His word. But anyway, but that's what makes him an expert. We have a few questions here. I'm going to try to get to them. So one question is, do you see, for anyone, this is for anyone, any map shifts with the vault? Like when you push it, does it change the map, and is it important? It's rare, I have to say. There is now a new feature in the system for shaping the catheter, and that makes it more reliable to see the actual shape of the catheter. It's a new, softer version, the inside X. And I have to say, with this low rate of muscle stimulation, there is not an issue on patient movement, so losing the geometry, not seeing that. So Atul, do you measure routinely any, like for hemolysis, do you get any blood tests after the check for hemolysis, and if so, in what patient is this important? So right now, we're doing it on everybody. We're doing it on absolutely everybody that we do PFA, but this is part of a protocol that we're doing. You know, I'll say three things about measuring hemolysis parameters. Number one is that the most important parameter is the plasma-free hemoglobin. You don't really have to measure haptoglobin and LDH and even hemoglobin. You know, creatinine maybe is a reasonable thing. Secondly, the preclinical models in the pig actually very accurately predict what hemolysis in the human is going to look like. So even though I showed you human data and preclinical data, and you're like, well, the balloon was only preclinical data, I'm willing to bet that that's going to be replicated almost definitely within a few significant figures of what was in the preclinical model. I don't think you necessarily need to measure it in everyone. If you're confident that the system that you're using is not causing a lot of hemolysis, then, you know, maybe after convincing yourself with the first five patients, you can just put it to rest. There is another question. Before we go to the iPad question, do you see any gaps in the market that you think we can address or we should address? Yeah, that's, you know, honestly, between all of the various tools and the proliferation of companies that are out there, I don't really see any specific gaps in terms of the tools. You know, I personally think, you know, a form factor of a grid type thing is a unique, really interesting tool. But, you know, we've got balls, we've got baskets, we've got, you know, linears, we've got everything. So what I think the gap is, is how do you put that all together in that right magic combination where you're getting almost no complications, you're getting the desired depth, and that just takes a lot of practice, practice, practice, modeling, modeling, modeling, And having worked with the preclinical team here quite closely, I mean, that's what they're doing. They're practicing, practicing, practicing, testing, testing, testing, and hopefully they're getting investment, investment, investment. But, you know, that's what they're doing. It's hard work. Can I ask a follow-up question related to amolysis? So by the time your urine darkens, you've got dramatic amolysis. Yeah. I mean, that's, I think, an important message. You're in big trouble at that point. Yeah. So that's not an end point that's acceptable. You have to be preemptive and obviously know that there are triggers or catheter designs or other issues that may put you at risk, certainly related to lesion number. Exactly. And be proactive and try to prevent this. Yeah. And I know we're out of time, but the other thing that's not acceptable is that for there to be on your system a counter which says, oh, you've hit 50 lesions, please stop ablating because you've passed the hemolysis threshold. I think that's bonkers, bonkers. So before we wrap up, just one last thing, because I know people are thinking about this. Just this is for the whole group. When should we do one shot and when should we do point by point? Even though, you know, we have PFA now, point by point, and we have the one shot, and we just saw this. We saw the vault, we saw the tacti-flex, and we saw the grid. And people are going to ask us, and they are asking us, actually, this is the question, when should we use which one in what case? And I think we'll go down the line and then we'll close with that. I'll comment very quickly. I think we can predict patients who are going to have non-pulmonary vein triggers. I think that we can identify people that likely have a significant substrate and have voltage abnormalities. And those patients, we probably have to be prepared. It may be that the numbers, if the prediction is really good, that we'll be able to take the few patients where we start out with a single shot device and switch and accept the increase in cost. We have to sort of figure this out. Monica? Yeah, so I think the paroxysmal, de novo, the no substrate base, as you said, vault would be easy to do, reduce, and again, kind of history of other types of arrhythmias. But now if the grid comes out, people that have kind of substrate base, that would be a good tool to use. But I think the kind of, if we're able to use this whole armadillo of different, tailored to different patient needs, I think that's important. I'm not smart enough to tailor anything to patients. I can't predict what patients have. I don't know what patients have. So I'm just going to end up probably in the future picking a medium form factor device. And using that for everybody, because I'm just not smart enough. Uri is here, and he said he will package them all for you. You can use whatever you want in one case. So he'll just charge you per case. Wow, three for the price of one? All right, so I'll open all three. Just kidding, guys. I just made that up. Okay. Helmut? Same. Along the line of a tool, I think it's difficult to predict in a given patient. I think what we might need in the future is a better understanding of the mechanisms of atrial fibrillation, better imaging, supported by artificial intelligence to then have some prediction of what we need in a given patient. Otherwise, I think we are too much in the dust at the moment. I don't see, there is something like PFA, PBI, single shot, first do, okay, I accept. But everything else is hard to predict, I think. I think we are too much in this kind of thinking, you know, you have to use this, this, or this. There is so much variability, and we don't know what the mechanisms are. That's it. When we go for voltage mapping, for example, if we use the grid, a lot of patients do not have posterior wall problems, they have septal problems and anterior problems, and I think we don't have all the strategies available at the moment to then really know what we should do. I think we should ask the question the other way around. The other way around would be first understand the mechanism and then build up the approach and the technology. Give me a technology and then tell me where I should use it. That's the other way around, in my eyes. Claudio? Well, I think I reiterate what I stated before, so if I have a, you know, a de novo paroxysmal, I will go for one shot right now, but obviously, as, you know, Frank already stated, we need you to predict, you know, some patient probably need you to switch to point by point, it depends on that. And I would like to have the HD3 for VT's ablation. That I'd like just to have it tomorrow in my shelf. Thank you. We're going to stop there. We're going to stop there. Tomorrow. I know. We all want it tomorrow. Thanks to all the speakers, the moderators, Abbott as their sponsor, wonderful event. Thank you. Thank you to the audience.

pulse-field ablation

atrial fibrillation

Volt PFA system

Abbott Balloon catheter

TactiFlex PFA system

RF modalities

lesion creation

technological advancements

single-shot techniques

patient-specific approaches