On this episode of The LEAD, we're recording live from EHRA. I'm Mike Lloyd, and today we'll talk about repeat procedures after pulse field ablation for AFib, the manifest redo study. This is in Europace this month. Our commentators today are Drs. Antti Anic from the University Hospital Center in Split, and Konstantinos Vlachos, an electrophysiologist from a small group in Bordeaux. Welcome to you both. Antti, let me start with you. You know a lot about pulse field. Tell us about the rationale for this paper. Why was it important? That's another piece of data coming from a big collaborative effort. Initially, it was 24 centers that were part of a limited market release after Therapos, the platform, was approved in EU. And later on, the new centers are joining that manifest experience, the data gathered to that registry, have become very vital when discussing about pulse field ablation, especially pulse ablation with pentaspline. We learned a lot so far, but this was a very specific question, to understand what are the findings at the PVI check procedures, or lesion center ability check procedures with patients with recurrence after index PFA with pentaspline procedure. Right. Kostas, how do they do this? How do they attack this question? So the redo procedure, I mean, the operators could choose their ablation strategy. They could use PFA, either cryo or RF. They could map if they had the mapping system, otherwise they used for achieve to check the veins or the far away also to check the veins. So it's a bit heterogeneous, the mapping, but you can understand if the PVs are reconnected. It's also important to understand that in the first, the index procedure, in some cases they had eyes and mapping, but not in all the cases. And if you see the results are related with if they used in the index procedure, the mapping system or eyes. And the ablation strategies was depending on the operator and the center. So it's a bit heterogeneous. So sorry. And also it's not only PVI, the operators could do either mitral line or posterior box isolation. So the redo procedure, it's really heterogeneous for me. It is very different, a wide group. Antti, what were the outcomes of these redo procedures? Yeah, just to add to what Costas has said, you know, so initially 55% of patients at the index procedure received ablation because of paroxysmal AF. The rest were persistent AF. And one third of the population that came for the remap received posterior wall ablation on top of PVI at the index procedure. A third. The results were somewhat disappointing. And the results have to be commented and seen in the broader context. From my perspective, I'm a bit disappointed in my European counterparts that we only have 45% of population coming for the remap and having always isolated. If I would be having this percentage of my patients coming for the remap post-RF PVI, let's say for post-closed protocol PVI, I would have to say that I'm not doing the best job possible with the technology. Likewise here, I think we have to understand that the manifest redo data is showing that there is a learning curve because these were the very first procedures. Many fellows were primary operators in this. We don't have this data, but many fellows performed the index cases. I think there's a strong signal that in this European experience, we did not exercise the full potential of the technology. What are the reasons for that? We can argue, but however, this is the main line I get from the results. The good news is that after ablation, so these patients coming for redo ablation. After the ablation, most of them retreated with RF, but one-third of them retreated with PFA again. Two-thirds were arrhythmia-free, with persistent AF being the strongest predictor of AT-AF recurrence post-redo procedure. These are the results. So you're saying that this relatively high reconnection rate is more of the operators than the technology itself? Am I hearing this right? Three things that we have to state out clearly here. It's a very initial experience with TheraPulse in the centers. And we talk about not only initial experience with the platform, we talk about initial experience with the energy source because this data is captured in a very post-market experience with TheraPulse that happened to be the first PFA platform ever approved. So you had operators naive to the platform, naive to the energy source. A large proportion were done without any imaging. And as Costas said, use of any imaging modality was associated with a higher proportion of durability at the remap. Either eyes or mapping system. This is important. Costas, what else limits these data? What should be cautionary for this trial? First of all, I completely agree with everything he said. We must be careful. I mean, the results, I agree, it's disappointing. I mean, it's 45% to have durable four PVs. But we must always think that it's a redo procedure, which means that the patient has arterial arrhythmias recurrence. So I think it's a bit, we don't check all the patients. So maybe the percentage is even more, the durability maybe it's not 45% because we don't include patients that have arterial arrhythmias free. We must be very careful also because we don't have a control group. This is a limitation of the study, I think. And also we must rethink, at least for Farapals, what we were saying at the beginning, that it's the learning curve is so fast and it doesn't matter. I think it matters. It's super important to have the experience with a catheter because if you see at the beginning we were doing two applications, repeat two, but now we must do anterior carina, we must be careful with the ridge, let PVs, there are specific positions of the veins that are reconnecting. And I think the real reason is the contact and that we never touched. It's not because we must see when we touch the region, what is the reconnection and durability. Because when we never went, for example, anterior carina or ridge or the inferior part of the right inferior pulmonary vein, it doesn't mean that the Farapals is the reason. It means that we never went there anatomically. And I think this is one of the reasons that imaging and ICE increase the precision of arterial arrhythmias. Good point. Good point. Antti, in SPLIT 2025, Pulse Field, state of the art, what are you doing in your lab? For de novo paroxysmal affibrillation, it's a pentaspline in almost 100% of the cases. And for de novo paroxysmal without additional substrate. We do pentaspline PFA, we do at least 10 applications, it's fluoroguided and ICE guided, 10 applications at least for the left-sided veins and 12 applications at least for the right-sided veins, anticipating that it's the only lesion set. This is why we do more than eight minimum. What we miss, what we miss in manifest redo, is the proportion of patients that received minimally recommended, so eight per vein, that received an index procedure. We don't know what is the proportion of the patients that received less at an index procedure. So we are leveraging our experience with the persistent AI population where we invented so-called anchor lesions, posterior directed cateter in flower posts to improve the durability of the posterior aspects of the vein. So in SPLIT, it's 100% of affiliation is PFA, we are believers to PFA, and this belief is not only based on our long-term, long-term term, we have more than six-year follow-up because we are part of the pre-CMARC trials like costal centers in Bordeaux, pre-CMARC in theropods. We believe in PFA, it can be the solo energy source to treat AF ablation, of course in paroxysmal PVI works in 90% of the cases, but in persistent population it's not enough and we do more. For doing more, we need another solutions that can penetrate deeper with a contact feedback and with a smaller ablation element not to encroach a hemolytic threshold risk. I see. Costas, you've been with PulseField a long time, probably from the beginning of its inception. Do the Bordeaux group think radiofrequency is dead for atrial fibrillation? It's a great debate even in Bordeaux between physicians. We'll see, really. I think my personal, maybe I will tell you my personal, I think for the posterior wall and the posterior part of the PVs, I think it's over for me. I mean, in three, five years there will be a recommendation maybe to do PF because we have maybe more than 200,000 cases and we don't have a fistula. It's really important not to have a complication that it's lethal. But for efficacy, really I don't know yet. What I wanted to comment regarding the study is also important to say that 31 and 35 millimeters, there was no difference. The size of the cutter. The size of the cutter because there was a debate also from this. And also that in the study we did posterior wall isolation or roof line or mitral line and the limitation, great limitation of the study is that we don't see how they check the line that we did because maybe it's more arithmogenic and this is the reason of recurrence and not only the PV. I mean, I don't know your opinion. That's true. We have a hint because the posterior wall ablation in manifest redo population, posterior wall ablation was predicting of AT recurrence as arithmetic on a remap for the redo. So this is a, we have indication. And also durability of posterior wall, again, it's less than satisfactory. It's less than this platform can give you. We've been discussing the manifest redo trial at EuroPace with a nice editorial with Dr. Konstantinos Vlachos. Thank you both very much for your commentary. Thank you.

pulse field ablation

AFib

TheraPulse

reconnection rates

operator expertise