Good afternoon, everyone, and thank you for being here to our Rhythm Theater, Transforming AFib Treatment. I'm here today with Dr. Amin Al-Ahmad, with Auntie Anich, and Dr. Coco and Frank Coco from Trident Health in South Carolina. Today we're going to talk about the development of the FirePulse system, and then also some new developments in AFib management, flutter management, in new catheters that Dr. Anich is going to talk about, and also how to map AFib, and at the end, maybe some also new applications of the FireWave system or the FirePulse system. So the story goes all the way back to 2012, and that's when FirePulse was founded, and then Boston Scientific had the insight to invest in this up-and-coming, and actually transformational, just going with the theme, transformational therapy that I think now everybody's using. And then the rest, you know, is first in human, and then all the way until it was approved, and since then, it's just taken off. So who is doing radiofrequency ablation right now for AFib ablation? I don't see any hands. So that's good, because that's the way it's going. Two hundred thousand or more patients now have been treated worldwide with FirePulse. It's approved in more than 12 countries, in the APAC region, 53 plus in the EMA, and of course, in Latin America and the U.S. and Canada. So basically, it's worldwide. Why is it important? I think the design, I think I've said this in other settings also, that this catheter was specifically designed for pulse field ablation, and that's to start with, in the beginning of the journey of PFA, this was one of, I think, the only one that was specifically designed in the beginning for PFA. It's a large, so that's what we have, the pentaspline for paroxysmal AFib, and I think it's also very good for persistent AFib ablation, and even, you know, for redos, I've been using it for redos, but I think we also, you can look down the list there, that there are other things that can be done with the catheter, and also, on the left-hand side, I mean, on the right-hand side of the slide, you can see other things that are coming into view here with the story, and it will address many different needs. I think the whole technology is coming along towards where we can address all the needs that you have in managing atrial fibrillation, and then later on, maybe even ventricular tachycardia. So you have the faraway with the pentaspline, you have now an integrated mapping system, you have the Farapoint, we will talk about it later, I'll talk about it later in a little bit, and then Faraflex, that Dr. Anich is going to talk about, and also mapping atrial fibrillation. All right, so this is the, is this, Frank, you can take over from here, thank you. Sure. Well, thank you for having me. I'm going to talk a little bit about the faraway pentaspline catheter, and now the faraway pentaspline NAV catheter that integrates with the OPAL mapping software, so we, that's called Faraview, and a lot of us have been using this and adopting this, I know we've become big adopters of this for our mapping for our AF cases. Let's see if I can get that to move. So why is this helpful? I find it super helpful because, first of all, you can use a single catheter workflow, and if actually, if you use the Faradrive Connect, you're basically going transeptal, and then you're able to build your anatomy immediately with the same catheter that you're also going to use to ablate, and it allows for different workflows. I think, you know, traditionally a lot of us would create a map, a shell first, and work within that shell, and then we'd bring, come back and ablate in that space, but I think as you adopt this technology, and I know we have, we've really shifted our workflow to be able to basically, as we're mapping and where we see that we have good contact both with the mapping system and with ice, we can then just deliver our lesions as we move across, and it just becomes really efficient. As you all know, one of the biggest advantages of PFA is that it's efficient, it's fast, and this workflow actually even capitalizes on that and allows us to do that, so you can create anatomy, and you can use both the basket and the flower configurations to create that anatomy, and then in that anatomy, you can then apply your lesions, and as you're going to see, we're going to look at some of the features that we use when we're mapping and how we assess lesions. You see here, in terms of dynamic visualization, the software allows you to visualize in real time when you change the shape of the catheter, and it's really quite accurate. It's been, in our experience, been a great experience, and it really works well, so there's no more sort of guessing what shape you're in, and actually, there's actually features in the software that if you do get a misshape, one of the splines inverts, or there's what we call a cobra, you can often see that the catheter sort of doesn't behave normally, so you know you're in the wrong configuration, you know something's back, and you got to go back to home base, but this dynamic visualization is fantastic, and as you know, if you use this catheter with other mapping systems, you sort of have to kind of tell it what you're in. You don't have to do that with this software. The software knows what shape the catheter is in, and represents that for you appropriately, and then, Boston Scientific has added, sorry, I want to go back to that, field tag technology. As you can see on the right there, there are basically, it takes one electrode from each spline, and then basically creates what the field would be, and calculates what the electrical field would be around all of the electrodes on the catheter, and then represents that in clouds, and then you can basically color code it, sort of like we do with other mapping systems where you would have dots, except now you sort of have these clouds of field tags, and you can represent with color how much you've delivered, and then if you have overlap, that color will get darker, so you can actually see where perhaps you only maybe put one lesion in one spot, and then you can overlap it, and Boston Scientific really went a step further, and they did a study, which I'm going to present here in a second, that validates these field tags, and you can, as an operator, can choose what size field tag you want. You can use five, six, seven millimeters, depending on how conservative or aggressive or however you want to represent that to be, and I'll tell you anecdotally, we use six millimeters most of the time, and you'll see why, because we represent that. And this is sort of what the field tags, by the way, look like from on the right here. You can see in the basket configuration and the flower configuration, as you move around, you move in closer proximity to the tissue, those field tags will project onto the surface of your map, and that can give you a sense of, you know, where are you getting some contact, and you'll see, too, we'll have some other features looking at contact. But I want to briefly present this data, I believe it was presented at this conference, the NAVIGATE study, where basically using about 15 patients, they validated the actual field tags using both the fairway NAV catheter mapping with electroanatomic mapping as well as a high-density mapping catheter as well, and it tagged the, what they did was they tagged the areas with pulse field ablation and used their field tags, and then once they created that, they then could calculate the difference. They then did a voltage map and looked at where there was a change in voltage in a low voltage border, and then they compared the field tags to that to basically get a validation and see how close the field tags would represent the actual lesions by follow-up mapping. And as you can see, these are the high-density volt maps, and then basically, they superimposed the field tags over those maps. So if you used 5-millimeter field tags, that was your overlap, and you saw that basically you kind of underestimated how much you ablated by about a millimeter and a half. If you used 6-millimeter field tags, you're pretty much on. You're within a half a millimeter off, and if you used 7-millimeter field tags, you probably have overestimated a bit where your electrical field was delivered and how much ablation you were done effectively. So that's why we use 6 most of the time. I haven't really found a need to play with it too much. It's been pretty accurate, but I would defer to some of my panelists if they had that experience. And then in a single patient, they actually came back and validated the chronic lesion durability. So they generated anatomy. They did tagging, and they did a map with both Fairwave NAV and the Orion catheter and got a map and basically did a 60-day remap. And you can see that, you know, they did the veins in the posterior wall here, and they overlapped. And then what they did is then they overlapped that, the field tags onto that map to basically show that the level of isolation chronically was very similar to the field map that was done. And so this is my last slide and last thing that I'll talk about. I think a big exciting feature about OPAL and the arrhythmia technology has been how fast the Boston Scientific Engineers have started to respond to operators like us into what we need and what we think is going to improve the system. And so I remember back when Cardo 3 first came out and I was a junior attending, I remember, you know, we got new software updates every couple of months it felt like with improvements and responses. And this is what Boston Scientific has been doing as well. We've seen multiple iterations of improvements in the software. And this is one that's going to be coming later this year where basically you'll be able to calibrate your catheter in the blood pool, which will only take a few seconds. And then it gets a reference impedance in that blood pool. And when you push the catheter up against tissue in close proximity to the tissue the impedance will change, it will rise. And you can set that at a threshold you like, but usually it's about 15 or 20 ohms. And then that will represent which electrodes you have that are touching the tissue and give you an idea do you have contact. I personally also use ice. I think this is another tool in the toolbox that's going to help us and really help us sort of use, integrate the mapping with this. And you can see in both the flower and the basket sort of when it lights up in yellow, that's when you have tissue proximity. So I think, you know, these have been great features and we're seeing more and more improvements as we go. That's great Frank. So I'm looking at questions here. I'm remembering to refresh the iPad. I don't see any questions. So I mean this is great tissue proximity and contact is important really for better outcomes. But also you don't want to be ablating when you don't have any contact. So could you tell us more about, you said you mentioned ice. So do you think there will be a day where we don't really have to look at ice to gauge that contact, to what extent? Yeah, I think, you know, obviously for now I definitely think ice is really important. And as you know, we don't want to ablate in the blood pool either. I mean we don't, in theory that might be increasing our risk of molluscs or other issues that we see with PFA. But I do know that new catheter design is in development. And so FaroWave or FaroNav 3 is going to be coming out, the new catheter. And that will actually be able to calculate not a single electrode but all the electrodes on the penta spline. And I think that's going to give us an even better, a better assessment of tissue contact and where we are with the mapping system. Great. And just segue onto the next part of the discussion today. Do you think that the penta spline can do everything? Do we need a point-by-point catheter? Well, I definitely think we need a point-by-point catheter potentially for other applications. I will say, as you know, I did a live case a couple days ago where we did the CTI with the flower. It works fantastically well. It may make a pretty big stripe. It's definitely a larger lesion set. But I've used this catheter to do a lot of linear lesions as well. I've used it for SVC isolation. I've used it for mitral isthmus, even for left atrial appendage isolation. So it really does, it gives you a lot of options. But I do think that FaroPoint is going to have a lot of applications. So let's talk about FaroPoint then. I'll be talking about FaroPoint. So we're moving on. So this is a FaroPoint. This is the answer to the point-by-point ablation. So sometimes we do need point-by-point ablation even with the PFA. And I mean, why? Mostly really for flutters and maybe some focal atrial tachycardia. And then towards the end of the discussion today, also when we want to go after certain sources of AFib or areas that we think are sources of AFib, and we'll talk about it in a little bit. But this is the basic catheter design. It could be biphasic, and it's biphasic bipolar PFA. And it's delivered very quickly, within 2.5 seconds. And the electrodes, as you can see there, E1 and E2 are together. And then E3 and E4 are together for the ablation. And then they are also independent, but they're independent for sensing electrograms. So you have very good electrograms on this catheter. And you can also map with it. And it actually gives you a very quick map. You can also do a lot of auto-tagging of energy applications. So once you come in, it tells you where the ablation happened. So this was advantage. And then phase 1 and phase 2. Phase 1 was already talked about and presented. But phase 2 was just presented on Thursday. The difference is that in phase 2, the CTI was done with PFA using the Farapont instead of radiofrequency. And also in phase 2, all of the patients had a LUX implanted monitor. And what did it show? So this is the phase 1 primary results. I thought it would be important for you to remember that this was phase 1. One year freedom from the primary efficacy event of any atrial tachycardia was 63.5%. But symptomatic recurrence and need for intervention, freedom from that was 85.3%. So very good results, again, for persistent atrial fibrillation. Now you add in advantage AF phase 2, where we said the difference was we used the PF for CTI and we had loop recorders. So you can see there on the right that when you use the PF catheter, we got very similar results with respect to blocking the CTI. And then, of course, I have to remind everybody that we had to use nitroglycerin to avoid vasospasm in that area. So that's that on the Farapont. Let me see if anybody has any questions from the panel. I have a question about Farapont catheter. So it's obvious that when you're ablating, you have to have all electrodes outside the sheet. This is important because many of us use the, you know, not all of us have same workflow and same approach to the CTI. You know, somebody like dragging from tricuspid annulus back to IVC, some like it to take it above. But personally, I love this approach from above. It's so easy when once you get over the CTI with your osteoblast sheet, it's so easy to control the things under CTI. So you have to be fairly outside with this catheter. You know, did you have any problem with reaching some pouches? Because if you're only, you know, if you have deep pouch and it's not wide isthmus, you know, I don't understand how can you ablate it just by dragging. You have to come in from above. So I think we were able to mitigate that. We did a lot of these in the study and, you know, obviously we did have on some of the cases feel like we had to get the pouch. I will say that this catheter makes bigger lesions and it makes them fast and it does a very good job. Now, one of the things we obviously do too is we had ice and we could manipulate around some of these pouches. Sometimes I think that helps mitigate. But we were able to get our catheter down into the pouch and just basically, like you said, use your sheath but then just unsheath it a little bit. It wasn't so long that you couldn't do it. So you're also satisfied with the quality of the flexion mechanism? It is important. I was. It will be important because, you know, to come close to the standard of care so to be able to come back, come down to ventricle with this catheter. So there was a question and I'll pose it to the panel. Is there a way to turn off a spline that's not in contact? No. The answer is no. Not at this point. Not yet but maybe in the future the engineers can work on something like that. But that's a good point. It will come. So it will come because the R&D team from Boston is very busy. So they're doing and putting more wires. So you will eventually, with a Faraway 5.0, you will have a single spline contact. And eventually you'll be able to ablate from the single spline. And then another question was, will point-by-point PFA replace the need for a focal RF catheter? Maybe eventually. We're not saying that everything has to be PFA. There is still a lot of instances when we need to use radio frequency. In the interest of time, we're going to move on. Next is Dr. Anic from Split, Croatia. Excellent friend of mine and collaborator for a long, long time. And he's going to talk to us about a new catheter that is here just for full disclosure. This is not approved in the United States. But the first in human studies are being done right now in Europe. So, Antti. You did the first ones, by the way. Thanks, Samad. So, you know, what's the need for this? You know, obviously you can tackle all the arrhythmias now that you have a Faraway multipolar. It's Ferrari for PVI. And then you have a focal solid tip catheter that you can do all the rest. It's a slow device for, let's say, PVI. But for the rest, it's really a good device. And now this is an intermediate design. So, it's like a SUV car. So, it can take you anywhere with a reasonable, and be reasonably fast. And reasonably good to everything. So, like a multi-something device. So, Faraflex is the current design. The current design is like a 41st or 42nd iteration. And in 2019, we did essentially the first focal PFA to be performed. It was essentially with Faraflex catheter. But that was a Gen 1, Gen 1 original Faraflex. This is the completely redesigned catheter. And you see it's a nitrile cage, laser cut. And then you have these electrodes on it that do the ablation. And it's a fantastic catheter. We're going to talk in details. So, the Elevate PF clinical trial I'm going to present here is that it was Osama and I we did the first in human cases back in February. So, just fresh out of the market. So, it's the typical design. It's a single arm, early feasibility and safety study. And the secret ingredient of the Elevate PF is that post, let's say two months post ablation, patients are coming for the invasive remap. And if you have invasive remap as a part of your protocol early on, that gives you opportunity to do a gradual development and gradual refinement of your PF science. This is very important. Typical safety and efficacy outcomes were deployed here. So, it's a nine millimeter PFA catheter. Large focal, we call it, or large area ablation. It has essentially six splines. And you have this forward facing sensor electrode. In different sensor electrode, there's a unipolar reference. So, it's a Orion-like quality of the electrograms. And there are shaft electrodes. You have also, sorry. So, there are, sorry, I can't see that. There are shaft electrodes here. There are shaft electrodes here. And that also can serve for ablation when you do in a bipolar. So, you can see here on the right hand panel, you can see the field projection. And comparing monopolar and bipolar. So, with this catheter and with a new generator, you can do also bipolar and unipolar to suit your needs. So, this is a very typical case we did within the Elevate PF. So, we start a case. We start a case. You see the setup. It's an ice guided single central septal. We put also CS catheter. And then, with this catheter, we make a shell. Because you are very dependent. Because when you use lesion tagging, you're very dependent on geometry. You take some time, especially with the focal catheter. You want to take some time to take a really good shell. Because later on, your projection will depend. So, let's say we took 11 minutes to map. And we collected more than 3,000 EGMs in 11 minutes. And we talk about full chamber map of left atrium. So, once we have full chamber map, we start ablation. And in this case, it's a deep sedation case. So, this case was done with deep sedation. It took us 8 minutes for the left WACA. 36 applications. From the outside, the artifact on EKG, you can see it looks like a regular Ferropulse PFA artifact. So, it's like 2.2 seconds per application. And here, in this case, you go dense red when you overlap with two applications. So, it demands two overlap applications to get dense red. Which then you can proceed. Right-sided, it took 9 minutes to do right-sided WACA. 36 applications. Obviously, we're doing maybe some over applications. But however, you know, it's early safety visibility. We have to be safe. And we also care about durability. And in this case, it was a female patient with a heart failure. So, we really wanted to do our best and take control early on. So, here, what you see here, it's a unipolar. And you see that there is a signal. The system is signaling that the proximal electrodes are covered. You see the shaft. The proximal shaft electrodes are covered by the sheet. That's a warning sign. Because if you're on a bipolar, you're not allowed to do that. But this was unipolar. So, we are good to go. So, when you have a good PVI shell, then it's so easy to do posterior wall. Look. So, it took 2 minutes to drag from left inferior to right inferior. And it took 3 minutes to do upper line. Again, with substantial overlap. So, not to have reconnections. The scatter design also allows... You can see the ice footprint. The good thing about this scatter... In general, not only about this. So, these large focal are easily visualized on ice. And I think it's quite important. You'll see now that we progress to the right, to the upper line. And only after a few applications, you will see that I'm going to check... We're going to check posterior wall. The hands you see down there is Osama is on ice. And you see, as soon as we apply here, we're going to go here. And we're going to check posterior wall. You see there are no potential. It's isolated. But then we're going to do more. And we're going to do more overlap. Because the septoplanoid bundle is an enemy of the PFA. So, let's say it took 5 minutes to isolate posterior wall. And then we... Because we really want to take care of this patient and have control of AF. We pursued and we did anterior mitral line. And essentially, in this case, from the start, we knew we're going to do something that is called percutaneous Cox maze. So, it took 7 minutes and 27 applications. And as we are finishing the anterior mitral line, you will see here that now with this application, after this application, the AF will organize. This is something that we see often with pulse field ablation cases. When you do PVA and posterior wall, they tend to organize. And especially if you do peritral line, they tend to organize. Now you see the organized rhythm. So, what do we do? Now we remap that. It was clear that the left atrial was bystander. So, we went to the right side. Now it's obvious from these maps. It will be obvious. Because this was one of the very first full chamber right atrial maps in organized rhythm, we took our time. So, we took 12 minutes. But you see here, it's a typical flutter. Please see the activation. So, the next thing is easy. You drive your catheter. And it took four minutes to ablate the CTI. And with the ablation and with finishing our line toward the IVC, we interrupted flutter and restored sinus rhythm in this patient. The beauty of this case that it took one hour, three minutes to perform left atrial map before ablation, to do PVI, posterior wall isolation, peritral line, to do remap, to do right atrial map, and to do CTI. So, in about one hour, with an investigational device, we were able to recreate what we call full lesion set or Cox-Mase procedure almost. And you see the beauty of this case that we already remapped this patient. Sorry. So, these are the maps. And the console engineer can give you an appreciation of how good was your overlap. You want to see what happens if you did three overlaps or four overlaps to predict possible gaps in the future. Again, the beauty of this case that we already remapped. And in this remap, you will see that we confirmed that the posterior wall is inactive. And so, we have durable box lesion. And we have block across anterior line in the atrium. So, what's next? So, now, this field tagging that obviously we use here is very intuitive. And we love it. However, I think the right direction is not only to have operator idea, where do you project your field? Obviously, the contact feedback is important. The tissue coupling with any PFA character is important, especially when you're doing unipolar and when you're doing this. So, in future, the very next batch of patients we're going to treat, we'll have also this idea of it's an impedance-based metric. We're going to have idea of contact. Having contact feedback plus projecting your field, I think it's a way to go for this kind of characters. That's great. Thank you. Thank you, Antiem. That was actually a very rewarding case. Because this was a patient who had persistent atrial fibrillation for many months. And her ejection fraction was starting to drop. So, it's nice and rewarding that you can do the first time ablation from persistent AFib to sinus rhythm. Now, the Faraflex catheter, by design, can also map. And it provides a high-density mapping. So, what Antiem did not show, but when the patient organized, we mapped that flutter in the left atrium. And it was very quickly clear that it's the right atrial flutter. Took the same catheter. We did another map in the right atrium and proved that it is CTI-dependent. And then terminated the flutter with a few ablations on the CTI line. And then, I don't know if it came out, but this patient was remapped two months later. How many weeks? Two months later. And it showed durable lines and isolation of the veins. So, a very strong technology where in one catheter, you can map and ablate even complex flutters. Now, should we use it in every patient? Who's the patient that you think, Antiem, in your mind, we should use the pentaspline versus the Faraflex, for example? Yeah. So, sorry. I'm wired. So, I think that it will be. So, in my center, we are having focal PFA for the last two and a half years. But it's a solid tip. So, I think, you know, there was 25% of patients in Advent trial that had beyond PVI ablation, mostly CTI. So, if I know beforehand, before my case, that I have to do PVI plus something, it's very likely that this will be my weapon of choice for the paroxysmal guys. And for persistent, it's very likely that this will be my tool, favorite tool for persistent. So, this large focal. However, you know, it's not easy to do cases in deep sedation. Operators, you know, in the States, it's not a problem. But in the outside US, many procedures were performed in deep sedation. And it's not easy to perform a focal PFA in deep sedation. In general anesthesia, it's lovely. And so, you know, it's also going to, you know, your choice will depend on how comfortable are you and do you have anesthesia support for your cases. In States, I understand it's not a problem. If I be having anesthesia support, large focal, it might be ideal, ideal, as I see right now, it might be ideal character form for persistent AF because you can do this. There are some other solutions for deep sedation that we are now doing, which seems like a case, but that's not a matter of discussion here. All right. I mean, this is an exciting catheter. People are excited about it. They're already asking, when is the CE mark and FDA approval expected for Fireflex? And the answer is, I don't know. Does anybody know when the timeline? It's very, it's, it's, it's probable that a Q1 2026 ID trial will start. Yeah. All right. Next is my turn again. And can I have the clicker? Yes. All right. Okay. So now I don't know if some of you asked the question in your head, but I was asking it to myself. Why did we decide to do an anterior line in this patient? And the answer is because when we mapped the original map, we saw some fractionations and thought, you know what, let's, let's do the anterior line. Now we didn't know that we were going to be lucky and it's going to change to from a fib to a typical atrial flutter. But the question is, well, wouldn't it be nice if you had something that can direct you to where to ablate instead of just guesswork? And this is where this next subject comes in, the cortex, which is the electrographic flow guided ablation. We'll talk a little bit about it. There was a lot of physics and science I'm not going to go through. Really, but everybody knows that it's an unmet need that in certain patients, whether it's a de novo ablation or a redo when you go in and everything's ablated. So this, our patient came back two months later and was mapped, remapped, and everything was ablated. What if she had a fib again? And what, what are you going to do next? So we need something that is really, has some solid scientific background to guide us to where to ablate. So this is a potential solution, electrographic flow guided ablation. What is it? So on the top there, let me see if I can get this, maybe this one. Anyway, on the top where there is a sun, that's supposed to be what we call a source. We will talk about it. And then this is just using unipolar electrograms and how they flow through the atrium. Supposedly, this is where things are emanating from, and that's why it's called the source. And ablating that hopefully will improve outcomes. So this is the basic question is, is there something that we can map with atrial fibrillation? This is just a very high level discussion or just explanation of what it is. It depends on the catheter there on the top left called the Optimap catheter with the AGF system. It's a 64 electrode basket catheter. And this is the important, the second bullet point there. It detects repeated propagation patterns in the chaos of Afib using unipolar electrograms. I talked to the engineer who was instrumental in designing this, and his background is actually in videography, in videoing how things propagate over time. That's his engineering thesis. This is where this idea came from, is that, okay, can you somehow visualize those unipolar electrograms as they propagate through the atrium? And if you can, then can you say, okay, it starts here and ends there? Just like, you know, you're doing also a micro-entrant tachycardia, for example. And from that, actually, the early work has been promising. Now, all of the bottom is just depiction of all of this math that's happening. And I guess they like the sun, because where things go, that's why it's bright yellow. But that's where a source, we consider the source of atrial fibrillation has come from. So, I mean, the goal, I mean, the final goal would be, could you use this to identify patient-specific ablation targets? Now, as you know, ablating the veins is all now empiric in people now. Of course, it's also deep-seated in science from 1998, where we saw that the triggers came from the primary veins. But beyond the primary veins, we really don't know more than that, unless you see it, unless you see, for example, a PAC causing a fib, and you can map that PAC, which is very, very difficult. That means you have to cardiovert the patient many times and figure out where that's coming from. But without having to do that, if we're able to accomplish this, this will be something that's very promising. Now, this next part is not my case. This is Dr. Shefdoshi's case. He had been in the study evaluating this technology. So this is the case study, 63-year-old woman, BMI 35, and she has HFPEF, of course, diabetes. And she's had already a couple of ablations. He mapped her with the EGF, but wasn't able to complete all the ablation because he didn't have PFA at that time. And it was close to the SVC and he was worried about the phrenic nerve and other issues. So he mapped, the reason I'm mentioning this is because on the redo map, the same areas were in that patient. So it's not moving, so it's not temporal. So in that patient, those sources were specific to that patient. And even though the maps were done many months apart, it was the same areas. So that's actually very important and very promising. And you can see all the cardioversions that they did. But anyway, they mapped it, they found, because she's already been ablated, that the sources were in the right atrium. And this is what the basket looks like in the right atrium there. And then they found these sources and he ablated her. But this was recent, so I can't tell you what the final outcome of the ablation is. Like, did she maintain sinus rhythm afterwards? But it's been a few months now, a few weeks, I should say. And I just talked to him yesterday and he said she hasn't had the recurrence yet. So this is really very promising. Now, and because of that, we came up with a new study. It's called the OPTIMIZE. So this is the first time a lot of you hear about this. This OPTIMIZE clinical study, we're basically designing it right now. I don't have the final locked in design, but basically what it's gonna be, it's gonna be de novo persistent atrial fibrillation patients. We're gonna do, we're going to randomize patients to what we do right now for persistent, which probably is gonna be PVI plus posterior wall versus PVI and EGF guided ablation. And then we're gonna put loop recorders on everybody and follow them for one year and look at the usual end points for efficacy and safety in these patients. And that's it. Next is Dr. Ahmed. Actually, your mic. You might just need this, yeah, thank you. Thanks, guys. So I wanted to show you this picture, not because, I mean, this was a very exciting day for us. This was the day we had commercial release of the Ferropulse system. So this was, you know, the pose you get and everybody's excited and everybody's happy. And look, I'm not trying to show you a picture of me smiling, but more importantly, this is a transition, right? So this is a transition to when this catheter is now real. It's in the real world. It's no longer in an IDE study. And all of us who've been practicing for years understand that when we have catheters in IDE studies, they do extremely well. And we really, really, all of us kind of care about how is the catheter gonna be performing in the real world? And I'm doing that to introduce to you the, how do I move this? The idea of the disrupt AF registry. And I do wanna give kudos to Boston Scientific for sponsoring this registry. So this is a real world registry, similar to the registry in Europe to sort of understand how does the catheter perform? How do these patients do in the real world? How are our patients doing? And how can we learn from each other and take things that we understand from this registry and improve our practices? And so we're gonna be looking at a lot of things and I'll have some data to share with you. But everything from the type of AF the patient has, is it proxismal, persistent, longstanding persistent? Whether they have any comorbidities? Also, we'll be looking at some of the procedural aspects, the timing of the procedure, the type of mapping of the procedure, the type of anesthesia of the procedure. Did you give nitroglycerin? What's the operator experience? And then post ablation, what's the quality of life of the patient? And is there atrial fibrillation and recurrences? How do these patients do? Are they still symptomatic and so forth? So this is going to be a fairly rich database. And as you can imagine with the success of the device so far, the Ferripulse device so far, the database has already accumulated over 1000 patients. Now we took this data cut just about a month or so before HRS, maybe a little longer than a month before HRS. And now we're up to 2000 patients. And so you can imagine the kind of data that we'll hopefully be able to get from this. And I understand now we have approval to even collect more data. So we'll be able to understand a little bit better how we do. And again, we do have data from Europe, but in the US things are a little bit different than Europe. So just to give you a slice of the first 1000 or so patients in this database. So as you might expect, paroxysmal about 55%, persistent about 40%, and longstanding persistent kind of the rest, four and a half percent. Average age is pretty consistent with what we know, 67. About 38% female, many of them had anaerobic drug use. Some of them had cardioversions, mostly normally F patients. And you can see the CHADS-VASc score is exactly what you would expect. But what we're able to collect here is now using this device, have we impacted things like our procedure time? Have we impacted our efficacy? Have we impacted the way we do things? And what you can see here at least, in terms of whether we're taking care of paroxysmal patients or non-paroxysmal patients, there's really no difference in terms of procedure time. What you can also see here is that in patients that are where this device is being used, the docs in the real world, not in the ID study, have adapted and figured out how to use this with very low fluoroscopy, or in many cases, zero fluoroscopy, which is common with other modalities such as radiofrequency, and with no real impact in terms of patient safety. Patient left atrial dwell time was very similar, so very, very interesting data we're getting. And we also looked at whether people are just ablating the pulmonary veins or they're going beyond the pulmonary veins. And what's interesting here is in the first few cases, people are just kind of sticking to the pulmonary veins. You can see that line, I don't know if you can see this, the line that's sort of going up like that is how much is PVI plus. And you see as people got more experience with the device, they started to take the device elsewhere. And as the other panelists sort of said, we're able to use this device in multiple locations. But importantly, with that experience with the device, and despite using it in a PVI plus modality, it turns out the procedure times either stayed the same or improved as we got used to the device. So as you got more experience with the device, and even though you're ablating with it more, we actually got better with it. And the learning curve actually did exist with this device and was helpful. All right, that may be it for disrupt, yep. Thanks. That was great. Thank you. All right, so we're getting here to almost the end, but I'm gonna take some questions from the iPad and from you guys. So there was a question about how is the OptiMap catheter different from the old Constellation? It's very similar. I mean, it's not much different. And then I like the other question is a design question on the study itself. Should we put loop recorders before so that we know what the burden is? I mean, that'd be great. I think it's a good idea. But sometimes logistically, when we have to do these trials, it's very difficult. And then you decide for how long do you want it before the intervention? It becomes hard to follow those patients. Now, because they're randomized, it won't matter. So everybody's gonna get a loop recorder and they're randomized. So the question is what is the burden after the intervention? I know the criticism will say, well, what if you had more patients in the one arm versus the other who had longer duration persistent or diagnosis, but it's randomized. So they should be equal in both arm. That's how we take care of that issue. One fantastic and probably the most exciting thing when I read the Advantage report with the ILR part was essentially that it is only when you put ILR, you can mimic, you can mimic any type of follow-up. So to be able to compare with other trials, because now we see some trials reporting very intermittent monitoring, and eventually they don't report on drugs, off drugs, all together. Oh, compare that to the continuous monitor, 30 seconds episode, yes, no, single, very binary nature of assessing our outcomes. I really don't like that. However, as long as 30 seconds of AF is indication for anticoagulant drugs, and unless you have a occluder, you have to use that. So the beauty of the story here is that, because you are able to report freedom from AF per definition, also you can try to put it in a real perspective and try to put it in trials. Freedom subsymptomatic AF, and freedom from AF if we used real-world monitoring, or the monitoring like it was used in most of the trials that have been reported. This is the most beautiful aspect of the Advantage trial I've seen. On top, reassurance that doing, in short-standing persistent AF population, if you do PVI, if you do PVI, posterior wall, and CTI ablation in the same procedure, and if likely to have durable, with PFA, and have durable effect, you're gonna have close to 85% of your patients being satisfied, and spending most of the time in sinus rhythm. I mean, and here, as we come to the end, I'm not seeing any more questions. You have 40 minutes, go ahead. But in any case, on this slide here, go back, yeah, on this slide, we're at, you know, Boston Scientific is really doing a great job in trying to address all these needs that we have. So if we start from the beginning, for example, pentaspline catheter, very important for paroxysmal and persistent AFib. I think it's very important for persistent atrial fibrillation. And then, you know, for VT and PVCs, it's not approved. So again, this is, it's very important to remember it's not approved. But I know of people who are sitting here who've used the pentaspline for VT ablation, for example. And with the, we will report them, but Tyler is smiling over there, but it's happened. Large focal map and ablate, which is like the Faraflex. I think, I mean, here they just put one plus, but it can be done for paroxysmal AFib and, you know, persistent. But I think it has more value in redos because you can use it to map and see where those gaps are and target that. Important for persistent atrial fibrillation, as you saw in the case. And you never know in the future we'll use it for PVC and VT ablation. I think this catheter, the Faraflex could be designed or is actually, work is being done on it so that it can deliver deep lesions so you can address PVC and VT. And you guys, you can jump in any time. Right side of pathways. You will love it in future, trust me, because it's not- Right side of pathways. Right revo pathways. You know, these are the things. We should add a column. Odorator band, PVCs, right ventricle. This is the design that likely will prevail. You will see because so easy to stay there with this kind of design. So contact assessment is important for everything. High definition mapping. Again, we talked about that. Very important for redos and persistent VT and PVCs. And then finally, you know, something that I'm really now very interested in. I think this is the next frontier. Is like how can we map atrial fibrillation itself and going from just an empiric approach to a personalized approach? Because those sources may be different in different patients, depending on the pathophysiology. So that I think is gonna be very important for redo ablations, persistent ablations. And then the personal ablation approach there for VT and PVCs is just, you know, good mapping. Because each patient's PVCs come from different places. Yeah, Osama, when you talk about mapping AFib, I think in the past, you know, it's always just been a daunting topic to even tackle. Not so much just because we couldn't always do it well, but also when you identify multiple spots, multiple triggers, it was just a lot of ablation to do in a setting. It would just take so much time and it would be exhausting. And you couldn't always create safe lesions. As you saw, like we maybe not wanna deliver a lesion near the phrenic nerve or other locations near the esophagus. But now with PFA, I think that just changes our ability to do this. Now, it's now realistic. Don't you think that we could actually map and ablate AFib in a reasonable amount of time? I think so. So, well, first of all, in the previous iterations of mapping AFib, many different areas were identified to ablate. Here, at least the preliminary data shows that in patients, it's only two to three areas that need to be ablated. And now that you have a technology that can deliver that ablation very quickly and very safely and not having to worry about structures around where we're gonna ablate, I think that makes it a lot less daunting. Now, it's still going to add time. But remember, those patients are the patients who really need that extra time and need that extra effort because they continue to have AFib despite previous ablations. And maybe they're developing heart failure. So in those patients, I think it's very important for us to have a solution. I think what ends up being kind of important for us is that I think with what we're seeing now with the PFA technology we have, we're getting very good results. We're getting isolation of pulmonary veins. When you go back in, the pulmonary veins are isolated. And then what we realize now is we're hitting that ceiling where we now are dealing with people with non-PV triggers and how do we identify them? Exactly like the patient you suggested. So this is really the challenge that I think is the next frontier with AFib ablation. If this can help us, it'd be great. And so I think we need to see some data. But I'm optimistic that there has to be a way that we can figure this out. Very cool. All right, I don't see any more questions coming in. So we're ahead of time a little bit, but thank you very much for your attention. And it's really a very exciting time to be in EP right now. Thank you.

Atrial Fibrillation

FirePulse system

AFib management

single-catheter workflows

Faraflex catheter

electrographic flow-guided ablation

Disrupt AF registry

pentaspline catheter

Optimap catheter