Welcome and thank you for attending this Rhythm Theater. I want to thank the sponsor, Medtronic, for this session, this educational session, really to discuss the new PFA system, the first FDA-approved system for PFA in the United States, the pulse-select PFA system, to talk about precision and durability. I'm Dr. Brad Knight at Northwestern in Chicago, really excited to be here with three fantastic presenters. A few reminders, if you can make sure at the end that you scan a QR code and provide some feedback at the end, you can turn your cell phones off, that would be great too. And we're gonna save, I think, the questions for the end of the program, so we'll each have a presenter for a few minutes and save questions for the end. So our first presentation is by Dr. Alana Kutynski, and she's going to talk about really the catheter, the biophysics and the catheter system itself. Dr. Kutynski is at Beaumont Hospital in Troy, Michigan, where she's been there for about 20 years and has a lot of experience with this PFA system. Welcome and thank you. Hi everybody, I'm Dr. Alana Kutynski, I'm at Beaumont Hospital, and we had the distinct pleasure of being the first in Michigan to use the pulse-select catheter, which was the first FDA-released PFA catheter, so it was a great day. And so we've had over a year of experience, and so I'm gonna briefly talk about, oh, I think I'm going the wrong direction. What do I hit? Pull up your slides, and there's gonna be a little lag for, show your disclosures that you can't. Here are my disclosures. Okay, so I'm gonna talk a little bit about the technology of the pulse-select catheter and the system that is available currently. I don't know, there we go. All of the pulse-field catheters come with a generator, so there is a specific generator for this catheter. I'm gonna stand up, because it's easier for me to see. I can't see that. My eyes are getting really old. He said 20 years. So. It's your high school. Right, right, I graduated early. Automatic, it has overcurrent detection, and the generator, the PFA generator, it gates to the R-wave, and you're able to do a test pulse, which was useful during the pilot study. We did that when we were near the diaphragm. You can still do that if you like. We don't recommend that, or I don't do that anymore. And it has a foot pedal, and it has a remote control, essentially. So I started using the foot pedal. I don't know about you guys. I don't use the foot pedal anymore. I have, yeah, no more foot pedal. It seems to take longer to hit the pedal, and for the operator themselves to use the pedal, so I have somebody pretty much just charging and ready to go. Every time I give an energy, they charge right away, and that seems to make the procedure a little more efficient. That's the generator itself. It's pretty basic. Then there's the steerable multi-electrode pulse-select catheter. It's nine electrodes, and it was built specifically to sense, ablate, and pace. So you can do everything in one, which is what I like. It might not be a high-density catheter, but you do get basic anatomy, and I do pace with it, and I take my math beforehand, and I do my math with it after, so I'm not exchanging catheters during my procedure. It's a 25-millimeter diameter loop, and it has a little forward-tilted array. It's a nine-front shaft, and it uses a .032 wire design, over-the-wire design. We're gonna talk a little bit about the bi-directional sheath. I do think it's a really nice sheath, and we'll go over the system a little bit more. So the pulse-select catheter, I think it's a really nice design. It's actually fixed electrode spacing, and so even if the catheter were straightened, which is not recommended, but if you were to open the catheter up, right, it comes in a spiral, it's fixed electrode spacing, so you always get a predictable result, which is not the same as some of the other catheters out there right now. It has a very stable delivery. I like over-the-wire. I got used to using over-the-wire with cryo. I think especially when trying to get into distal branches and add more stability for my catheter, over-the-wire is very useful. And then it does this 20-degree tilt, and so that is the furthest, that's your number five electrode, it's the furthest from your sheath. And when you push on the tissue, it sort of opens up the catheter so that everything is in contact. It's a really nice way of knowing that you're in contact if you don't use left-sided ice, or if your ice can't help you with that. So I alluded to this a little bit, that 20 degrees. I think that I didn't use it right away. I just sort of used it as a circular catheter. I think some of us are used to using a basic lasso, a basic circular catheter, but I think that when, we know that contact is important in these cases, and so I use, now we use the five. So if I see an electrode on two or three, and I'm gonna say that's maybe, oh yeah, so let's see. If you see electrograms on two or three, I'm gonna go back, it's still going forward. Okay, if you see something on two or three, electrograms, right, and you're trying to get the best contact, I'll turn my catheter and have five on that, and frequently that gives me better contact, and we know the better the contact, the better the lesion that you get. I think you also have some steerability with this catheter. It tilts, it moves to the right and to the left. The sheath is actually so good, I don't find that I use it very much. It's the slowest changer, there we go. Comes also with a transeptal, the FlexCath transeptal sheath that again fits right through the catheter. It's an integrated system. It has a spring-loaded needle, like a BRK needle that comes out of it, and it only goes when you, it's controlled with when you use it. You use your Safari or your curled wire, you advance the needle, you push your wire through, and then you bring the needle back in. So it is a safer than doing a traditional transeptal. The sheath is like one of my favorite parts. I'm a big fan of the FlexCath contour. I think that it is a more gentle sheath. I use the 13-millimeter tip. I think that the 13-millimeter tip helps me get into the right inferior pulmonary vein. And so when we started, I kind of played around with both of them, but now I pretty much am only a 13-millimeter tip person, user, it has bi-directional steering, which is really nice. And like I said, even though the catheter itself will kind of go to the right, go to the left, it leans to the right, leans to the left. I find myself not really using that part of the catheter design, and mostly I use the sheath. I think with the sheath, you can get pretty much wherever you need to get. There we go. There's a lot of evidence that went into this. If you look at the date of this article, it was in 18. So they have been doing work on this catheter for 15 years. My mentor, David Haynes, may he rest in peace, has been talking about irreversible electroporation for 15, 20 years. I think one of my old fellows is in the audience, and he had been talking about it forever. And so he worked with Medtronic, and they have worked tirelessly to come up with this technology, and they really have it down to a science. It preferentially ablates cardiac tissue. And in here, you can see that there's epicardial fat that hasn't been touched, and you can also see that there is the arteries that haven't, epicardial arteries that haven't been touched. So this is a full thickness lesion that doesn't extend past the epicardial fat, which is really nice. The lesions are contiguous, the way that the fixed electrodes are, which is also nice, and you can see that it causes rapid ablation. You might not get this right away. It does take time for the lesions to mature, but you can see a contiguous lesion that is full thickness with contact. We do know that contact is important now. I think that, at least when we first started, I thought it was like a force field, right? Like you just get the catheter near, and you could wave it, and it would work. And now we know that you actually do need catheter contact. I don't know if this is gonna play. So this is just, it was an animation. It doesn't play, I don't think. Oh, there's an arrow. There's an arrow. Thank you. My fault. You place the catheter, you put your number five, I do my five at 12, then I'll move my five, my five electrode to three, then I'll move my five electrode to six, and then I move my five electrode to nine. And that's the recommended protocol. What I do is I do four osteolesions, and then four anterolesions. My osteolesions are pretty tight, and then my anterolesions I do bring back. I'll show you one of my image. I think we're probably running close to time. But this is sort of the workflow. It's very fast. I like the over the wire. I think it stabilizes and centers the catheter so that it is easy to get that kind of really nice rotation. And let's go next. If you had a foot pedal, you wouldn't have needed me to push that. I need a foot pedal. I'm looking for my foot pedal. Where is my foot pedal? I can't even use the pointer. I don't know how I'm gonna work with the foot pedal. Okay. There you go. Okay. Dr. Knight is messing with me. I didn't do that. There is fixed electrode spacing like we talked about, which makes it really nice. This just shows the difference between the consistency of a fixed electrode versus different spacing, right? So some of the other catheters, if you have the electrodes go between the splines and if the splines are forward or backwards, your field is gonna be a little different. Like I said, because this is fixed, you could even stretch it out and you're still gonna have the same electrical field if you have contact with the tissue, which is really nice. Just a quick word about safety. This is a MOD database inquiry, which obviously has its limitations, but it did look at the year of data from December of 23 to December of January of 24. It looked at all PFA inquiries or whatever, when people send their information in because this is self-reporting, right? So they found lower incidents of procedural complications with the Pulse Select versus the flower catheter. Ferropulse had 319 events compared with 31 events in the Pulse Select arm. Most of those events were vagal. Most of the vagal responses resolved quickly. There was significant hemolysis in several of the patients. There were no significant hemolysis cases in any of the Pulse Select patients. The majority of these were catheter-related events. And if you look at the graph over to the right, most of those were sort of either inversion of the lead, or we were learning how to use the wire. A lot of it's the learning error and what wire you use. They've changed the wire that we use inside the catheter now, and they have techniques so that you don't knock the wire. But any over-the-wire procedure might have that. The good news is no A.E. fistulas, no strokes in the Pulse Select arm. It was pretty safe. Time-wise? A couple minutes. Okay. So my experience, this is kind of my screen when I do a case. I use my ice left-sided. So I do a, if it's a small heart, I'll do a single transeptal. I floss the septum with my flex sheath, and then I go over with my ice into the left. If it's a big heart, then I'll do two transeptals. I'll do my first transeptal with the flex sheath, and then I do a second transeptal with the versicross, and I leave my ice in the left atrium. I think we get great images with left-sided ice, and I can see my contact. And so I think that contact is important, mostly, not necessarily force, but contact, just having contact with the tissue. In the animal studies that they did, it definitely showed significant benefit when you were in direct contact with the tissue, and you don't see the microbubbles when you're in contact, and it gives, I think it gives a better lesion, less needing to go over, stack things, go back. This is fluoro, and then what I do is I do a, and when I give a lesion, it'll turn sort of pink, and then if I hit a lesion again, it'll turn red. If I'm hitting lesions in areas multiple times, it'll start to get more red, and so that's how I avoid stacking lesions. So this is my, this was my original workflow. What I do is I would make my map. This is a CARDO map. I have since kind of changed systems and used N-Site because I don't like doing catheter exchanges, and using Pulse Select and N-Site, I don't have to do catheter exchanges, and so for me, I think that decreases risks in the patient. When I first started, what I would do is we would take the, we would make a map, an anatomical map. I would go in, I would map where I would want to put my lesions. My red lesions are the osteolesions. My blue lesions are the antral lesions, and then I would clear the activity, electrical activity, and I would make it gray, and then I would kind of try to keep within these lines, and you can see that's pre, that's post. It's pretty consistent. I think the best thing about Pulse Select, and then I'm gonna finish up, is that it's very precise. Where you put your lesion is, if you go back and you map, that's where your lesion is, and so I had Pulse Select before I had anything else. I did three months of Pulse Select. When I was learning, what I did was, I mapped everyone pre and post with high-density mapping to make sure, because I just, we're all learning, right, and so I would go in, and after three months of mapping pre and post, I realized I don't really need to map post, because I can use my Pulse Select to map, so I don't necessarily need a high-density, I don't need to pull a high-density catheter to map anymore, because the Pulse Select, I feel, is good enough. Obviously, if this was a more complicated case, I would do what was necessary. So I think Pulse Select is effective and efficient. There's, you can limit your catheter exchanges, which I think is really, really important. Makes very precise lines. I don't see a lot of spread in these afterwards. I feel comfortable in patients who have a small heart. I can still preserve the posterior wall, and I'm still a purist. I don't see any reason to take out a posterior wall in a young, healthy person who has a healthy heart, and with this, I can do that. I don't see any vagal response. I don't give Robanol or Atropine before cases to block vagal response with this. It's not as powerful, the volts, and so we don't see that, and we have been doing hemolysis studies for over a year at our institution, and there has been no significant hemolysis. There is hemolysis, but no significant patient outcomes over a year with the Pulse Select. Thank you. All yours. So I look forward to the end of this. We'll have a discussion, talk a little bit more about the technology and the pros and cons. Our next speaker is Dr. Arianna from Sacramento, California, not far from here, from Mercy General Hospital, and he has to leave before we get to the discussion, but he's gonna talk about some comparative data looking at durability with the Pulse Select. Thank you. That's correct. Good afternoon, everyone. Dr. Knight, ladies and gentlemen, colleagues. So I'm going to now speak about the clinical outcomes of catheter ablation with PFA, with two different PFA systems, the Pulse Select and also its competitor, the pentaspline catheter. You've already seen my disclosures. So what I'm going to do, as I said, is to review the results of the midterm, I should say, outcomes of a retrospective, it's actually a perspective analysis of, I don't want to use this retrospective, my apologies, the perspective evaluation examination of outcomes of PFA using Pulse Select in a real-world setting. So what we did was we prospectively examined the acute and the midterm outcomes of patients with symptomatic atrial fibrillation who underwent catheter ablation using two different available systems, as I already alluded to. Despite what we just heard, I'm a little bit of a different approach here. I actually, in fact, performed PVA plus poster wall isolation. I'll, in fact, introduce some data that we've published on that justifies that approach. I realize it's not everyone's cup of tea, but for a minute, just keep that in mind that PVA plus poster wall isolation was performed in the entire cohort. Now, this was performed either using the circular multi-electrode array, i.e. the pulse-like catheter. 178 patients were ablated using this strategy, or using the pentosline catheter. Primarily, the 35-millimeter catheter was utilized for this purpose, and, of course, is the competitor of the Ferrowave from Boston Scientific. 162 patients were treated using that catheter. We have an approach in the lab where we, in fact, IV hydrate all patients with about three-quarters of a liter of usually lactate or ringers in nearly every case, at least, and as I alluded to, we've published previously on the outcomes of PVA plus poster wall isolation in patients with persistent atrial fibrillation, demonstrating that, in fact, there was a benefit favoring poster wall isolation in this patient cohort. Now, these are patients with persistent AFib. We've not only showed benefit in terms of, let's see if I can use the laser here. Maybe it doesn't work, but anyway, there's a difference, as you can see, in the Kaplan-Meier curves in favor of poster wall isolation during long-term follow-up, and there was also a benefit with regards to cardioversion during follow-up. In fact, it emerged as a significant predictor during long-term follow-up. Now, this was done with CryoBalloon, of course. We extrapolated the data to PFA and did the same approach with both catheters. Now, this is the other piece. These were what we just heard were, saw was rather, what we just saw was where the patients were persistent AFib. We also have similar data to be published recently in the last couple years, and Jackie will be here, in patients with proxismal AFib, where we demonstrated that even though by 12 months there were no differences in the outcomes between PVI versus PVI plus poster wall isolation, we had actually shown that, in fact, if you follow these patients longer term, beyond three years and out, there was, in fact, a benefit in favor of poster wall isolation, not only with regards to efficacy as early as two years, but also with regards to recurrence of, or need for, rather, repeat catheter ablation and also cardioversion, and also this immersion itself as a predictor of long-term benefit. So with that approach in mind, PVI plus poster wall isolation was performed in every patient using either one or the other catheter. Mapping was used in every case and heavily guided by 3D mapping. I do want to reemphasize, or emphasize, that we did perform a pretty agile applications, including targeting the ridge and also the carinae aggressively in these cases, and procedures were guided by intracardiac echo, which I tend to agree with my colleague. I do think ICE is valuable in this regard. These are some of the maps created before and after pre versus post, and these are the types of applications, locations of applications shown on the left, correlating with the net result. All mappings were, in fact, performed with high-density mapping catheters in every case. Now, results. All patients underwent PVI plus poster wall isolation, as I indicated, all 340 patients using pulse field ablation. There were no deaths, strokes, atrial esophageal fistulas, as you'd expect. What about baseline characteristics? They were generally comparable. When we look at the baseline characteristics between the circular multi-array catheter versus the pentospline, you can see that, for the most part, they're pretty well matched. For the most part, they were comparable. There were no significant variations in regards to these types of baseline characteristics. What about procedural characteristics? The ablation application numbers, on average, were about 62 for the multi-electrode array versus 68 with the pentospline. The duration of ablation was also slightly different. As you know, the recipe's slightly different in these systems. Therefore, that results in a significant difference between the two. There was a difference in the number of CTI ablations being greater with the pentospline catheter. This really reflected mostly the workflow at the time. Really, it was indicative of having had access early on to the first catheter, which was the multi-electrode array. We really were investigating the approach of doing CTI in those patients. We decided to, in fact, do CTI in everybody by the time we got to the pentospline catheter using the same PFA system. Otherwise, use of atypical flutters, I'm sorry, use of RF, rather, to target atypical flutters were comparable between the two strategies, as was catheter ablation of other cardiac arrhythmias, as you can see. There were differences between the two strategies in terms of fluoroscopy utilization. It was lower with the pentospline, and also the total procedure time was also lower with the pentospline catheter. Why would that be? As I did mention before, we predominantly used the 35-millimeter catheter when we performed PFA using the pentospline. I assume that has something to do with it. It's a bigger footprint catheter, obviously. Again, some of this could also reflect operator-learner experience curve, where we basically initially started out with a multi-electrode array as we graduated to the pentospline, and much of that really had to do with the fact that, as you're all aware, one was approved first in the US, followed by the other. What about laboratory data? Well, at baseline, there were no differences in the baseline measurements of hemoglobin, hematocrit, kidney function, and these types of metrics you see shown here. What was interesting was that two hours, as early as two hours, we did detect a difference in the total bilirubin being more elevated after performance of PFA with the pentospline catheter. This was statistically significant, and in patients we had data on 24 hours, we did, in fact, notice a difference overall in the kidney function. There was a slight increase in the creatinine and decline in the GFR in patients who underwent an ablation with the pentospline. By then, the bilirubin measurements had virtually normalized, or equalized, not quite back to normal, but pretty close. But I do want to emphasize that all laboratory changes shown here, all these significant abnormalities or changes, essentially normalized by 72 to 96 hours post-follow-up. Even though there was a slight difference between the two, they entirely normalized without any kind of interventions. No, obviously, dialysis was required in these patients, no sequela of any kind. In fact, I would say most of the changes normalized within 48 to 72 hours, at most by 72 to 96 hours. So there was a difference there. What about in terms of performing a multivariate linear regression modeling? Interestingly, despite this, the only thing that emerged as a significant predictor of change in kidney function and creatinine and GFR was actually duration of PFA, and not so much the ablation system. And what we found was that there was a cutoff that we could identify with each system that was associated with a transient decrease in the GFR, and that was 97 applications with a multi-electrode array versus 86 applications with the other catheter. Similar, interestingly, ablation times. What was also well correlated with this and emerged as significant was left atrial size. Interestingly, the larger left atrial size, we saw a more prominent change in the GFR. Again, likely also driven by more applications and the larger surface area that had to be ablated as well. What about safety outcomes? There were no safety differences in terms of overall. First of all, total adverse events were comparable between the two systems. When we look at pericardial infusion rate, it was comparable. Groin vascular complications, comparable. There was one case of catheter entanglement that was addressed without intervention. There was some bleeding associated with that, but it was not significant. In terms of the coronary artery spasm or arterial spasm, we did also observe one case associated with the circular multi-electrode array catheter. I do want to emphasize that was in the context of performing off-label ablation in the cavo-tract cuspid isthmus, and so that was not in terms of normal left atrial ablation, and that did, in fact, require further intervention. It was an unfortunate case where the patient developed spasm while CTI ablation was being performed using the pulse-select catheter, and we had pretreated with nitroglycerin. ST changes resolved. This was under anesthesia, so we couldn't assess any symptoms, obviously, but electrocardiographically and the hemodynamic findings suggested complete resolution of the spasm. As the patient was admitted to recovery, within about 35 minutes of the initial event, patient developed new onset, sudden onset VF, and we immediately noted, again, ST elevations when we shocked the patient. The patient was taken to the cath lab as it turns out the patient had multivessel disease. Interestingly, the patient had balanced ischemia in terms of having three-vessel disease, but even though they had a negative stress test, that balanced ischemia, making it negative, and so the patient had a significant RCA lesion that was associated with a rupture of a plaque, which resulted in that event. The patient received a PCI stent to that artery with excellent results. So in terms of follow-up, not surprisingly, the follow-up was significantly longer in this study with the pulse-select, with the circular array catheter, reflecting the duration of time we've had access to this catheter since it was approved by FDA about, what, 13 months ago? It was actually 15 months ago, whereas we devolved access, gained access to the pentospine about six months later. In terms of other types of outcomes, there really were no differences with regards to outcomes otherwise. So when we look at the need for cardioversion during follow-up, it was comparable. There was a trend, but not really significant. Again, it's hard to speak about that anyway because the follow-up's being quite different. Repeat need for ablation and then time to arrhythmia recurrence thus far are no different either. When we look at the midterm to longterm, I'm really hesitant to really talk about longterm. It's really, truly midterm discussion here at this point, especially since we have limited data on the one catheter. Thus far, they appear to follow the same trend. When we look at freedom from atrial fibrillation combined both proxismal and persistent patients, it seems to be comparable between pentospine and circular array catheter. When we look at proxismal patients alone versus persistent, also the same trend appears to be the case thus far. When we look at freedom from all atrial arrhythmias, again, the same thing. When we look at proxismal and persistent patients combined in panel D versus proxismal alone in E or persistent in F, again, thus far it's really difficult to really reach any definitive conclusions, but thus far there does not seem to be any significant differences. So that being said, sorry, I'm having difficulty advancing. There we go. Conclusions, in conclusion, the current study does illustrate, in fact, the safety and the feasibility of the circular multi-electrode array PFA catheter for performing PVI and postural isolation. It seems to be quite feasible for that in patients with persistent atrial fibrillation or proxismal and symptomatic AFib with suitable mid to long-term outcomes. And the efficacy appears to be comparable to that of the pentospine. Having said that, the pentospine catheter was associated with a transient greater rise in the serum creatinine and a decrease in the GFR by 24 hours, which did spontaneously resolve without any kind of intervention in this patient core that we observed at least, without any kind of intervention or sequela. But interestingly, in multivariate regression analyses, only PFA time, only ablation time, emerged as the most powerful, as the only sole significant predictor of a decrease in GFR and acute kidney injury. Thank you for that time. Thank you. Since you have to leave early, maybe we could ask a few questions now that pertain specifically to this paper. I'm actually impressed that you were not a, you didn't detect that much of a rise in bilirubin or not that much of a detection of homolacid, but you mentioned that you hydrated, you pre-hydrated everybody. Do you still do that? Do you do that for pulse select? I do. So it's been our practice, given the fact that we've used a variety of different PFA technologies, experimentally, we had this sort of preconceived notion that we should hydrate all patients. It remains to be determined whether pulse select does require that level of hydration, but that's been our generic practice to hydrate these patients, no matter what PFA system we're using, whether it's necessary or not, it remains to be determined. And you presented the case of when you use these catheters near the coronary arteries you pre-treat with nitroglycerin. The case you presented seemed a little odd because it was a delayed reaction in a patient with underlying coronary substrate, but for both of these systems, do you give nitroglycerin currently? We routinely do, and I know that's sort of 50-50 nowadays out in the real world. We routinely pre-treat because of that bad experience we had, and I'm not sure that would have really avoided this complication anyway. This patient had a significant disease, and I think it really resulted, most likely, it's impossible, of course, to know, but likely resulted from a significant spasm that was ensued by rupture of a plaque, I'm guessing, so it just, I think, opened my mind up to the fact that this could happen, actually, even though we pre-treat. Yeah, so to answer your question, I routinely pre-treat when I'm doing CTI. Be curious to know what the audience and everyone else does. So most of the data you presented looked at outcomes from a patient perspective in times and procedural times, but this sheath is significantly smaller than the other competitive sheath. Can you just comment on your comfort of use? Does that matter? Yeah, no, I think it's a fantastic question. Certainly, I think the catheter sheath is much smaller, easier to manage in terms of vascular issues. I think, in fact, if we look at it, there were no significant differences, but I think, as I recall, there were fewer vascular issues with this sheath than the other. So general perception would be that it's more along the lines of what we've historically been used to using than much larger sheaths and catheters. Well, I appreciate you doing this because there's very few comparative data out there right now, and it's a rapidly changing field. So I hope you keep comparing these new things. Any questions before he leaves? Do you guys have any questions? Actually, I have one question. How do you reconcile the number of lesions with the pentospline catheter was 96 and with the circular catheter was like 10 less? Yeah, because it's a much bigger footprint. So why do you think that you end up doing more lesions with the pentospline than with the circular? You know, it's a good question. Don't have a great answer to that. We just, you know, covered the... If you look at the left atrial size, I think there were, in fact, if we can go back to one of the baseline slides, the characteristics, I guess, I think the left atrial size was actually slightly larger in patients who did undergo the pentospline ablation. If I remember, if you can go back and come more slides, if I'm not mistaken, it had a larger left atrial dimension, if I'm not mistaken, didn't it? If you go back one more. So that could have been a reason, perhaps. But yeah, left atrial size. Second to last. The P-value, I think, is, yeah. So the P-value was slightly, so one is a little bit larger than the other. Could that have been the reason why more territory had to be ablated? I mean, 62 and 68, I think, are sort of in the same ballpark. But I think for the purpose of, since it's 340 patients, it emerges significant. But probably likely, in reality, did not have a whole lot of consequential difference. All right, well, thank you very much. That's useful information, thank you. Our next presenter is Dr. Antonio Moretta. He's going to, he's in Sarasota, Florida, and the title of his presentation. Thank you so much. Thank you. Dr. Knight. Thank you. Thank you so much. Oh, yes, thank you again for your attention. I'm off to late-breaking clinical trials for some commentaries and such. Not to participate, and I hope you don't mind. We don't mind. So this is gonna really be an experience and a case presentation with the technology. Thank you. So, good afternoon, everyone. So what I wanna talk about today is I'm gonna walk you through a case. But I wanna tell you a little bit about my workflow and how I, or what I find important when we're doing PFA ablation, okay? So I'm also a purist. I don't like what I'll describe later as collateral damage. So I don't ablate healthy tissue that I don't think needs to be ablated. I wanna ablate as little as possible with maximum effectiveness, okay? I also don't use PFA for any flutter lines, whether it be CTI, mitral liner lines, right? And precision is very important. So these are the main reason why Pulse Select has become my workhorse, okay? And on top of it all, I'm also a no-fluoro user. So I've traditionally done that, no lead. And Pulse Select allows me to keep that no-fluoro workflow. So let's talk about some advantages and the disadvantages of the Pulse Select catheter. So number one, it's a single-shock catheter. Kinda makes things a little bit quicker. But that's for all the single-shock catheters. What was mentioned earlier is that Pulse Select is precise. It's very precise. And I really like that. I like sparing healthy posterior walls, especially in pure paroxysmal patients. It can be used in the SVC. So if you do have a patient who's come back and they've had a durable PVI, durable posterior wall, I have isolated the SVC. It seems to be a trigger in some patients where PVI and posterior wall has failed. When I do it, I do it without pacing. So make sure you do it in sinus rhythm to look for any cycle length slowing because you can have damage to the sinus node. The sheet size, I think, is a big deal. So I think now that PFA is coming, that has come and we have so many different systems to choose from, we can't forget the fundamentals of what prevents complications. And smaller sheet size also leads to less vascular complications. Like I mentioned earlier, I do use a floralist workflow and I really like the FlexCath sheet. It is probably the smoothest sheath I've ever used to go across the the interacial septum and I'll show a video of that in just a bit. Some disadvantages is that it's difficult to assess for contact, right? So as a traditional RF user, contact force was a big advancement for afib ablation for me. Okay, and we lost that with with the single shot PFA catheters and we see that contact is important. Maybe not contact force, but contact is important. Not only for obtaining a PVI, but I think also for hemolysis, okay? The more contact you get, I think the less hemolysis you get. So, you know, in order to maximize the contact that you get, you really need to have a good relationship with your mapper. The mapper, kind of, my mapper really knows my workflow, knows where I have a lot of push out, knows where to shave, so then I can guarantee contact with the pulse select catheter. It is a little bit more difficult to maneuver than other single shot catheters, PFA catheters, so it took me a little bit longer to learn it, but I think once you do it, it's totally worth it. And, you know, in any of the single shot catheters, I don't think they're very conducive for flutter. You know, again, going back into the fundamentals of limiting complications, right? So for years, we've used RF for decades, we've used RF for CTI, and we did it safely. When pulse field came, we were excited about it because it limited atrial esophageal fistula, phrenic nerve injury, which is really, really rare. So I think if you start using these PFA, if you start using PFA off-label for flutter lines, especially CTI lines, you're really offsetting the safety that got you so excited about PFA in the first place. So here's a, you know, a video of me doing a no-flutter. So this is that one case that I'm going to walk you through. So this is, I just use ice, looks up up into the SVC. Let me see, does that have a pointer? There you go. And then I just bring the sheath down, and here I use the ice fan here to see where I'm pointing to, make sure I'm pointing between the appendage and the left veins. I tend to stay a little bit more anterior, and then we get our transeptal puncture there. And then I use two sheaths because I pre- and post-map. Okay, so that's something else that I find important. I do high density mapping prior to the ablation and high density mapping after the ablation. I agree with you though, I don't think it's as necessary post, but I think pre-mapping is important. So I pre-map with an octarray catheter. And so this is one of the maps here. Now as you can see in this patient, very healthy atrium, right? The posterior wall, in my opinion, does not need isolation. You know, PVI, pure PVI, has been the cornerstone for ablation, for success in limiting recurrence of atrial fibrillation, and I stick with that, even in persistence with big atrium. So the reason why I like mapping, especially pre-mapping before, is I'm always, well not always, I'm commonly surprised at what I find when I map, okay? So I'll bring in a patient with a huge atrium, bring them in and find that their atrium is completely healthy, and I'll just do a PVI on them. But conversely, I'll have patients who come in, small atrium, and they have scar everywhere, right? And I think prognostically that's important. So another advantage to the Pulse Select system is the flex sheath, or the flex cath. It really moves across the interatrial septum well. Do you mind, can you press the play button on the bottom there? Thank you, appreciate that. Now if you look, this is me exchanging. I took out the physical catheter, and now I'm exchanging over a wire, and I'm putting the flex cath, and it just goes through. You don't even see any tenting. That's how smooth it is. So it's a really, really nice catheter to get over to the left atrium. All right, so this is essentially just, now that you can get, now that you're across into the left atrium with the flex cath, how are you going to open up the Pulse Select without using fluoroscopy, right? And mapping is a really easy way to do this. I take a guide wire, and I put alligator clips at the end, so I can see it going into the left upper pulmonary vein. And then, interesting enough, you can use ice, and if you get good images, you can just use ice and see the Pulse Select open up in the left atrium. But also, you can just use three-dimensional mapping. And what I do there is, there's a slide that opens up the catheter. And what's nice is, all you have to do, once you see a couple of electrodes come out, like you see there, all you have to do is tap that slide a little bit. You don't have to push it out all the way, and the Pulse Select will just unravel itself. And that's real nice, because you know you're safe. You know nothing is obstructing you from opening up the Pulse Select. Okay, I'm gonna ask you to do a little bit more work. So, the top two both are videos. You can press play on both of them, or actually all four. There you go. So, I think this slide really illustrates well the precision of the catheter. So, what you can see here is, on the left, I'm isolating the left veins. Okay, on the right, I'm isolating the right veins. I'm not this fast. This is a two-time speed, just so, you know, I wish I was that fast, but I'm not. And you can see now, on the bottom images, here's my mapper showing all the different views. But where you put the Pulse Select catheter, it's not just the right view. Where you put the Pulse Select catheter is where you're gonna get ablation. You're not gonna get any more than that. And that'll leave a nice, big, healthy posterior wall in the back. Let's do this. Oh, there we go. Oops. Can we go back? Oh, there we go. I got it. So, here's the final result. Again, there's a nice, healthy posterior wall. No isthmus was created, because of unintended collateral damage. And you have a really nice lesion set with the PVI. I tend to do two osteo lesions per vein, and then eight total lesions. Okay, and where it, where I ablate, all depends on anatomy. One thing I do, I do find is, and I don't know for anybody here who uses Pulse Select, or if you guys have seen this, before, once I'm done ablating, and before I do my post-map, I always take the Pulse Select, and I put it in the left upper vein. Only because it's not uncommon, I'll find reconnection or signal in that upper vein, and I'll give a couple extra osteo lesions. And it's just there, because I used to look in all four veins. And I had ablate, and I just do a couple ablations there, and then I'll take the Pulse Select out, and put the Octaray back in for, for a post-map. And what's nice about the, about the, about this case, and using the catheter, it's just reproducible. It's not just one time. This is not the only case. I'm not showing you the best case that I've done. This is over and over again. You just get precise lesion sets, right, where you don't get any collateral damage, any areas, any potential isthmuses, that could cause any problems. I really did a lot of these, maybe too many, but you get the point, right? And, oh, and then I'll come back. And so, in summary, why, why is the Pulse Select my workhorse? Why do I use it so much? I've used every of the, all of the PFA technologies. I'm lucky enough to have a hospital that, you know, gets me all the toys that I want. But I choose this as my workhorse, my workhorse, because it allows me to do a floralist workflow. It, it requires the smallest diameter catheter, limits vascular complications. The trans, the transeptal sheath is, or the FlexCath is the smoothest transeptal that, that I've ever used with the sheath. It's a high level of precision. Hemolysis has not even been an issue. For most of my pure paroxysmals, I don't do many more than 40 ablation lesions, okay, in almost everybody. So we really didn't really, the most I've done is in, is 72 in a patient, and there was no hemolysis, or no clinically relevant hemolysis. It facilitates sparing healthy tissue, and it's safe and effective. Thank you, thank you. All right, well these presentations are open for discussion. I encourage you, there's a microphone if you have any questions. I think I'll start. It's an interesting time right now, and you guys, I think, presented two approaches that interestingly are much different. You know, we, you would think we would all be doing things similarly at this point, but you use a Navex mapping system, and didn't you do any post mapping, and it allows you to not open an ultra high density mapping catheter. You use the CARDO system to do pre and post mapping. Talk a little bit about what you think needs to happen to help us moving forward. Are we gonna keep doing it this way, or what's next? You know, I think, I think mapping is important. I'm a big proponent of it, and this is why, for two reasons. One is, pulse field ablation is new, okay, and yeah, we have data out there showing that you don't need to map, and you get the same outcomes, but I think by not mapping, you're doing yourself a disservice and not learning about what's happening with the pulse flood catheters, or with any of the PFA catheters. Like I mentioned earlier, you know, I learned through post mapping that sometimes in the left upper vein, I get reconnections. I would have never known that if I didn't post map, and I think there's a lot, and there's a lot of things you can garner from doing the post map. Areas that maybe are a little bit more difficult, areas that maybe we connect more commonly than others, so it really gives you an opportunity to learn more about a technology that really just started. What do you think? It's funny, I think mapping is super important, like it, but the only reason I'm, I don't, I don't like catheter exchanges, so because of the safety of exchanging catheters, and the potential for air embolism, I have gone to post mapping with the pulse select, and so it's one of the reasons that I've been using Insight, is so I, because it allows me, I can, I can, I have proximity indicators, so I can see contact when I'm, when I'm in contact, so giving lesions is a little bit easier, but which we didn't have with CARDO. Yes. And so it, I have this workflow where I know that I have contact, and, and then I map the posterior wall, I map everything after, because same as you, I want to make sure my posterior wall is healthy, and left alone, and, and so if there's any questions, I do pull in a high-density, high-density catheter, but I haven't had to that much. I, but I believe in mapping, and I agree with you, I think that this is a new technology for everybody, and we really need to understand it, and if you don't post map, then you have no idea, but when I'm doing the, when I'm doing FerriPulse cases, I have one hospital that only has FerriPulse, and one hospital that has whatever I want, and when I'm doing the FerriPulse cases, I always post map, I'll still, after a year, I still post map, because I, several times I'll go in, and it'll be a young, healthy person, and they'll have a generous heart, and I am very compulsive about keeping my lesions pretty tight, and I'll go back, and I'll map, and they'll be, they'll be really, the, there'll be a tiny isthmus in the posterior wall, and then I have no choice but to go back in, and do a posterior wall, and so I do think mapping is, post mapping is really important, and I mean, it's controversial, I would say people who don't post map with FerriPulse, it's, it potentially, you're gonna get a lot of patients coming back with, yeah, I agree, I think that, I think you're absolutely right, and you know, another thing is, I don't know if you guys do this, but the map, and you don't need a post map for this, but at least a pre map, I use it prognostically, so like I mentioned earlier, if I have a patient who has a high scar burden, my conversation with the patient and the family afterwards is, you know, changes, if it's a, if it's a completely normal heart, I'm like, listen, you got a good shot of never getting AFib again, but if it's a lot of scar, it's like, well listen, yeah, in a year or two, you're probably gonna need another ablation, or if it's, you know, just super scarred, it's like, listen, we're not gonna come back, the next step is an AV node and a pacemaker, right, so I think we can use mapping prognostically as well. In terms of durability, I'll be honest, I haven't brought many patients back with any of these systems, they've done pretty well, but when I did a patient in the clinical trial for the pulse select, we brought one patient back, and I was, you know, very compulsive because it was a clinical trial, there was a reconnection in the right middle vein, and I actually do a pulmonary venogram in all cases, even though we've moved away from pre-procedural imaging, but it taught me what you mentioned, that you probably need contact, you need to be in contact, so in order to optimize that, you know, you appear to put the ice in the left atrium in everybody, you don't, I don't routinely, some of my colleagues do, why do you not? I don't because I think we have a workflow good enough to, I'm confident in the contact that I'm getting, and I don't think that I need to, to be honest. Yeah, that's the way I feel, I mean, I suspect that I would use less floral if I did that, but I feel like using floral, the mapping system, and ice from the right atrium gives me a pretty good idea of contact. Do you feel otherwise? Do you feel like, oh yeah, most people would think I'm in great contact, but I can see that I'm not. So I actually, I didn't have, I didn't put these slides in, but I have slides of, it was a pulse select case, and I did, did the whole case, and went back and remapped, and the right inferior was totally not, was, was not isolated, and when I went back and looked at the end site images before and after, the, the pulse select was sort of on its side instead of on, because I'm trying to cut down on any floral, and so then I went back and I redid it, got better ice images, and that's one of the reasons I now use ice, because I can see beautifully my contact, and, and so I do think that it makes a difference with having, ensuring that you have contact. Any other specific anatomy techniques we should talk about? So left common, how do you approach that? So what I do is, I do my osteosimilarly, and then I come to do the anteroles, and, and I sort of use the number five-like point catheter, and so I'll, I'll kind of put it out there, and then I'll turn it low, a little lower, and then turn it a little lower, and turn it a little, and I'll work your way, all the way around it, yeah. But when you say osteo, you go to the bifurcation of the veins, even on common? On the common. Yeah, I do the same thing. It's nice when you have the wire, right, and you're, you're on the osteo, both osteum, and then I do a wide. Yeah, we used to use a lot of cryo, and I think you learn that wiring different veins gives you different approaches, so even the right inferior vein, just like we learned from cryo, wiring the lower branch of that vein, get your catheter in a different spot, sometimes gets you under the vein. Any other comments from the audience here, questions? I'm curious, you have one hospital that just has pulse select, and one that has many, like. Well, we have one hospital that only has ferripulse, okay, and one hospital that has all, all the toys, because one's like more of a community hospital, one's a university hospital, so I've sort of gone to pulse select at one hospital, there's an end site and pulse select, and the other one only has cardo and ferripulse, and so that's sort of, I'm lucky, right, I get to, I get to use both, and I think that they're both very good systems. I think that, I agree with you that the pulse select takes a little while to master it, but I feel a lot, I feel that it's a lot more precise, and for me, I still, I'm still, I trained as a RF ablationist, and and I like that precision, I like being able to feel like I have some control over, over what I'm doing. I agree, I think that I really like the precision of it, I think it works, it's real nice, it did take a little bit longer to learn, but I think it's totally worth it. One other thing that I kind of like to do when you talk about anatomical consideration, I really, I think the septum is also rhythmogenic, so yeah, when I, when I do my, and I don't know if you noticed in those pictures, but when I do my right veins, I'll keep the posterior wall tight so to keep it open, but that septum, I'll blast after septum. I've started doing that also, so I, I had to go back in and do two redos, and it was the, the right, like kind of right anterior septal area that, so now I extend that out a little bit, and I hit it, I hit it really hard, and I tighten my posterior wall. Especially if you see those fractionate electrodes. I'm so happy that, that you have the same findings. Indicated, indicated. Since this is a Medtronic event, I think we can fairly say that there's this, an afferis system now with its own mapping system, if the pulse select were able to be displayed and part of the afferis system integrated, would you think that would be a big advantage over what you're doing? I, so yes, I think it would be a little advantage, not a big one. See, the disadvantage to the afferis system is that, number one, you can't see any other catheter, and number two, you're only stuck with those, with either one of those catheters. I'm just saying like, you know, in the future, it would be nice if this were integrated into its own mapping system. I think that would, that would be a big advantage. That would be helpful, yeah, for sure. Any other comments? We have about a minute left. No questions? Come on. All right, I think we'll, we'll stop there. I want to thank all of you for being here. There may be a QR code at the end for feedback. That would be great. I want to thank Medtronic for continuing to support these educational activities. This is a great informative session. I learned a lot, and thanks to these two great speakers who stayed for the whole time. Thank you. Thank you, guys. Thank you.

Rhythm Theater

Medtronic

pulse field ablation

Pulse Select PFA system

FDA-approved

vascular complications

no-fluoro workflow

catheter efficiency

mapping systems