All right, so anyway, welcome to the iRhythm session. It's a pleasure to be here on behalf of Phillips Healthcare here at Heart Rhythm Society meeting 2025. I'm very blessed to be here with my colleagues. We're gonna present to you some cases and some data about concomitant left atrial appendage closure with pulse field ablation, which is really facilitated by having a good understanding and technology that involves volumetric or 3D ice imaging, where we'll be discussing the Verisight Pro Catheter, which is a 3D ice catheter. So since we have a short time to do all the things we wanna do, we're gonna cut straight to Dr. Ricardo Lugo from Nashville, Tennessee, who has graciously offered to do a live case for us. And before I forget, I wanna mention my two colleagues here on the panel here, Dr. Anisha Meen and Dr. Kevin Makati, who will also be presenting some data and their perspectives about the concomitant procedure. So with that, Dr. Lugo, please go ahead and get started. We'll make you full screen. All right, thank you so much. We're really excited to be joining you guys from Nashville. I can just really quickly introduce the team here. Of course, many thanks to Phillips for helping to put this on and allowing us to share our experience with these procedures and this technology. To my left here, we've got Kelly, our CRNA, Mark scrubbing with me. We've got Caitlin from Medtronic supporting us, Aaron from Boston Scientific, Omar from Phillips. We've got Russ, our echo tech, Levon, the former echo tech here now with Phillips, Dr. Ricey, Dr. Ryan Ricey, my partner in crime with all things structural. And yeah, I think with that, we can present the patient. I think also thanks to my partner, Dr. Steven Farig for referring this patient to me. Ryan, you wanna take it and introduce the patient for us? Sure, good afternoon. This is Ryan Ricey, Advanced Imaging Interventional Echo. So this patient is, let me present the case. So before that as a presentation, but 71-year-old gentleman with history of hypertension prior to tobacco use, had a history of paroxysmal AFib beginning around 2015. And deferred medical rhythm control due to concern about side effects. The patient had some chest pain episodes and after ischemic workup, coronary angiogram showed obstructive lesion at proximal ramus status post DES-PCI. The patient required a pacemaker for conversion pause in 2024 and still paroxysmal AFib with some episodes above more than 24 hours. The patient had easy bruising with anticoagulants limiting his lifestyle and CHAS-VASc score three based on age, hypertension, and vascular and has a blood score of three age and NSAIDs and predisposed to bleeding. The surface echocardiogram showed EF of 60% with mild MR and of note, we always document that this is a non-valvular MR and or mitral valve disease or AFib. And non-valvular AFib left atrial volume was huge, 53 milliliter per meter square. Yeah, so we got some pre-imaging as kind of the standard for us with the concomitant workflow. We'd like to know ahead of time what we're getting into and more or less how we're gonna approach this case. So we got a CT heart structure morphology and we put it through 3MENSEO as kind of our standard workflow here. Correct. I can explain it but Bill. Ricardo, not to interrupt you guys but I'm gonna go ahead and take my prerogative. We have 16 minutes for you to do the imaging and to do the ablation. So maybe we can just cut to the fact here you have some pre-imaging which shows us kind of the appendage which is probably important to know what you're going into but we'd love to see what you're gonna find when you get in there. I think you can describe this as really a kind of a windsock with distal trabeculations and some angulation on the appendage but I'm just gonna push you to go along and show us the images. Yeah, sounds good. So let's go to our ice. We can cut to our echo here. We started off obviously you always wanna get some baseline pictures. This is our home view. You can see the right atrium, right ventricle. Go to the next echo image. Cross into the right ventricle and from there we can clock around and get a baseline survey of the pericardium. You can see this gentleman has a very small pericardial fusion, it's circumferential. Keep clocking and you'll be able to see the appendage. This patient was in AFib at the time. We cardioverted him out but he's been compliant with his Eliquis. Took his dose this morning even. I do these on full anticoagulation just to make sure that it's gonna be clean and sure enough it was. So then we go on and do our transeptal. So we can skip ahead. Here you'll see our X-plane through. We use the FlexCath cross. Just to give a second, if you can go back to that. I think one of the advantages since we're talking about Y3D ice, the advantage is to be able to do something like this like an X-plane from a single location to really identify as was relevant to doing an ablation where you wanna puncture with PFA is relevant but also where you wanna puncture with for appendage closer, anterior, posterior, inferior, superior. And this is stuff that it's not as easily seen with 2D ice but when you're able to go back to that. X-plane as we're doing the transeptal. I can't agree more. It's probably a undervalued feature but something that when you go back to 2D ice, you're like, what? You can't explain through here and you've got a fan around. Can you explain real quick which view is showing what? Yeah, it's beautiful. In the right view, you see the aortic valve all the way to the right. If you would just go back for a second. Back guys. And then that's gonna show us our anterior, posterior and on the left, you'll see a bicable SVC view. So you can continue on. Just thought I'd interrupt you. No, no, no, thank you. So then what we do, we can cut over to the X-ray feed for a second here. So now let's go play. So you go forward. Here we go. No, backwards. There you go. Yeah, so this is us coming down. Go to the next one. And it's a really nice system, the plexiglass cross. Just kind of take the sheath, then go to the next one. And this guy had a very, very difficult septum, very floppy. So we took a couple of back and forths with the sheath to be able to dilate it. But I'm usually able to get the ice catheter across the transeptal. Go to the next one without too much difficulty once you have dilated. Next one. So for these cases, we're pretty much doing left-sided imaging of the ice catheter as you showed us there. Just for the audience. I think it is imperative to do left-sided imaging. Okay. I don't think you get the level of detail that you need unless you're in the left atrium. And we're gonna show you some really cool things you can do with the ice catheter once you're there to help facilitate your PFA workflow too. All right, let's look at what, so what would you do next? You're gonna measure the appendage with ice? No, let's go back to ice. Yep, and we can show the measurements of the appendage. And yeah, so here's an X-plane. We can also do 3D multi-planar reconstruction. So basically in one view. Can we take them off the screen just to see the full screen of the echo? Yeah, go right ahead. Yeah. So once you get your multi-planar, you can even do just a circle around the whole circumference of the appendage. And it'll give you kind of a max and a min diameter. We got 26 millimeters. Pretty close to what the CTEA said. CTEA tends to overestimate a little bit, 28. So 26, this is kind of within that realm of difference. So I think it's very important also to get this imaging before you do your ablation because I think as some other people have presented it, there's a lot of data. I saw some abstracts at HRS talking about edema on the ridge really affecting the measurements of your appendage post-ablation. So the next thing we did here after we got our baseline images was that we ablated the left-sided pulmonary veins with the pulse select. I do four kind of ostially and then four anterally all around the circumference for each vein. We've done the left-sided pulmonary veins. We were saving the right for you guys. So let's come back live with ICE and we can show you where we're at right now. This is a view you're never gonna get from the right atrium. This is from the body of the left atrium. You are looking down and you are looking at that right superior. And it is very unique here in 2D, but then we flip over to a volumetric 3D and you're gonna be able to see a level of detail that really I think helps to facilitate better outcomes for the patients because you're gonna be able to see the contact that your catheter is making with the tissue as you're ablating. The 3D mapping I think is important. Of course, helps to reduce your floral use, but with the current generation of technologies, we don't really have that impedance-based measurement just yet to tell us whether or not we're in contact. So this is a great way to see that. So I'm gonna pull the catheter back just a little bit and you can see, we're just kind of floating in space here. And then as I advanced it and put it in contact, now you can see the catheter is lying very nicely in contact around the circumference of that vein. Can you show us that in biplane, please? Maybe 45, minus 45 something. Sorry, what was the question? Can you show us that in biplane? Yep. Can you guys show us that in biplane? Right. And you have about 10 minutes to isolate the vein, so no rush at all. Take your time. Yeah, we got plenty of time. Yeah, yeah. There you go. Well, it looks like I'm a little, I totally collapsed. I think, Dr. Lugo, what you're demonstrating here is that when we have a three-dimensional catheter, we can, especially when we're doing an ablation at the same time, oftentimes there's some difficulty in manipulating the ice. So using the digital steering here really helps get crisp visualization without losing position on your therapy catheter. I'm gonna be focusing on my ablation and the digital steering, the ectotech can be doing all that adjustment work for us while I'm working over here. So are you happy with that position in terms of your first application? Or maybe you can also show us. The first one was good, the second one was not. And so I think it kind of got a little slanted. So I ended up, when I pulled it back here, I was able to kind of reassess that a little bit better. So I think while he's adjusting, I just want to add that what I've found is when you leverage 3D ice in trying to isolate the veins, sometimes you inevitably need to be segmental about it. And you spend less time trying to get perfectly circumferential, just use the tool to segmentally take out the vein. And I like that, the literature shows that the superior anterior aspect of the right and left have the highest rate of reconnection. So you could purposely target those areas to make sure because it's thicker tissue to get more lesion density in those particular areas. And can we go to full screen and kind of see your whole screen? So we'll see the ice, we'll see the floor, your map, just to kind of, so you've already applied some applications, is that right? Yeah, this is number five, right? Yeah, that's possible. Hmm? That's possible. Perfect. Yeah, so I'm starting to work on some of the wider lesions now. And it's interesting, when you deliver the pulse field, we don't see a lot of noise on the ultrasound channel, which oftentimes can be a little bit annoying, if you will, but it's been very smooth. Yeah, you'll see almost nothing. Can you show us your 3D map while we're doing, just to kind of get an idea of how that. Yeah, let's go to the big screen where you guys can see the big screen of all, everything. Yep, I think it might have moved there. So now we're gonna split this, get something more anterior and wide. And let's see here, I'm gonna try and make sure, there. This is nice and wide here. And anterior, let's go in here. And Dr. Hugo, how much of your manipulation is based on the ice images versus your 3D map images, or is it kind of, what are you relying? Because sometimes we find that, while the map may look like you're in contact, when you look on ice, you're still floating a bit. That's exactly how I feel. I think the map is great for reducing your X-ray. I think that trying to assess tissue contact, it's kind of hit or miss. And there we go, let's see. I think this is gonna be a nice area, the anterior on the ridge. You can do one here. These are very dilated veins as well. So the whole pulse select can easily just kind of slip inside of there. So trying to titrate these wider lesions, it's very helpful. Trying to see, and you can see that volumetric. Oh, let me swing that around a little bit better, maybe. It looks like you routinely use the 3D image to guide contact and navigation. Shep, do you use the 2D or? Yeah, you know, I mean, just to clarify, biplane is still 3D, you're collecting a volume of data. I prefer to go from a biplane perspective and find two angles where I can see things at a different resolution. I think occasionally I will put on the 3D to get a global look, but on an individual basis for applications, oftentimes we'll cycle through the biplane, but I think it's really what is your workflow. Dr. Lugo, can we ask your mapper to go to a larger, to a zoomed in picture, because your head is blocking. Yeah, can you do a single, Carolyn, on the 3D map, just to get rid of the side image? Yeah, there we go, yep. Can we zoom in there a little bit? Can you zoom in on this right inferior pulmonary vein? Yep, there we go. And then you can rotate. Obviously, if you need the other image. So you can see we're on the right inferior now. Okay. That's nicer. And you can see, oh, we had a really good view on the ice. Yeah, we can see how circumferentially we are here between the two pulmonary veins. This is a great example where the circumference of the pulse select is actually on the posterior wall, yet your map would suggest that it's partially over the os. And I think this is the power of 3D, is that it is the truth, and the map is a surrogate of that. Yeah, yeah, having that truth gives you that extra level of confidence to know what you're doing. For the mappers out there, realize this is an impedance-based map, right? The catheters are not integrated. So those are the kind of errors you're gonna have. And that's why the ice is really important to, as you said, speak the truth. And I see there you're rotating through, okay. Okay, yeah. That's a nice image we can see. That's a nice 2D, you know. And can you do zero and plus 45 on that? Zero, 45, we can't. Yeah. So we have two high-resolution images there if we biplane that, and you can line the zero up with the vein. That's a fine image here. And so how many applications are you in there, Ricardo? In here? We have six more to go, I believe, for this right inferior pulmonary vein. Yeah, that looks really nice. Can you move the M-line on the zero so it's over the catheter? We don't have one here. This is good. And you can keep the right one at 45. Zero and 45, it'll be fixed, and then you can adjust your M-line. Yeah, right there. Yeah, perfect. Yeah, you can see how we got that. And it's such a precision tool, this pulse select. It's really nice. You can be very precise and know that you're not obliterating the posterior wall when you don't want to. That's a nice wide one there. Better contact. Yeah, that's good. So the two panelists are on the podium here. So from your workflow perspective, do you do things any differently? Do you even do any mapping and just go ice, fluoro? What are the different ways of doing this? Because I feel like if ice is the truth of contact and you have fluoro, do you need to map necessarily? I think it depends on the proposed lesion set. So in our practice, if we're doing a PBI-only workflow, our primary navigation and contact or apposition assessment is going to be ice. And if we're planning on doing a more robust lesion set, we do incorporate 3D mapping. Usually that's low-density 3D mapping, just from a cost perspective. As far as an ice workflow, we do follow something very similar probably to what you do, Shep. We generally like to use the biplane view to optimize the resolution and use the 3D only sparsely. Kevin, you do things a little differently. Yeah, so I have really gravitated towards using 3D almost all the time. I use it for pulmonary vein isolation. I use it for posterior wall isolation. I do anterior mitral lines under 3D guidance. It's just once you get the comfortability, you have to build the internal encyclopedia of images to get to the confidence level of just getting away from mapping. But once you do, you realize how far from reality the constructed map is. You can get it to approximate the endoscopic view of what you see on 3D, but it takes a lot of time. So for an efficient workflow, we've just gone all in with using 3D. Because I would figure, I mean, we're black and white old school. You're more color. Just even based on your outfit, I can tell that. I would figure that the quality of the imaging will be very high because you're directly in the left atrium and you're just shooting through the blood pool to get. That's, I think the biggest hurdle when you're starting off with that workflow is getting it into, getting accustomed to putting the ice in the left atrium, but it's another world. I mean, the visualization is unparalleled. Well, I think that's an important thing to bring up because as we talk about concomitant procedures, we can see the field gravitating to intracardiac echo for the second part of the procedure, which is appendage closure, because you can imagine from a workflow perspective, you can certainly do a TEE as you put them under anesthesia, but then to call them back to do the second part is always a challenge. And so while there's only 90%, I mean, less than 10% of appendage closures in the United States are done with intracardiac echo. 90% are TEE. As we swing to concomitant, physicians are, and that's why there's such an interest, is are looking at ways to learn the techniques so they don't have to call the echo person back and can just do it themselves. And certainly volumetric ice facilitates the ability to do less catheter manipulation and see the whole appendage from one location, which will facilitate the procedure. So tell us where you are this far, because I can see a nice view in fairly looking up at the roof and the pulmonary veins and appendage. Yeah, so I think we're really happy. I think we've got our PBI complete at this point. I'm gonna switch gears and take an injection of the appendage so that way we can kind of move on to occluding that. Yeah, if you want to do the injection, what we'll do is we have two presentations, about eight minutes each, so you guys can get prepared for your appendage closure. And if you want to do any pre-map or anything like that, or post-map, certainly we have about 15 minutes, and then we'll come back to you for the appendage closure part after you get this angio done. Sounds great. Do you want to save the angio for later or do you want to just do it now? We can save it for later. Okay, perfect. All right, so let's do that. With that, let me introduce Dr., I guess we have Dr. Makati's slides up yet. We were gonna, let's just have Dr. Makati go next. Ablation with 3D VeriSight is probably a perfect transition to what we've just seen. Okay, here, first of all, thank you, Phillips, for inviting me to talk about 3D ice and leveraging it with PFA, and a pleasure to talk with my colleagues. Here are my disclaimers. So I want to show you the workflow of how we use just 3D ice without mapping. So it's exactly as you see it, transeptal, LA placement, a visualization of the entirety of the left atrium and the orientation of the veins. And I think this is really important. The more that you put ice in the left atrium, the more that you realize that the veins don't take off from the left atrium discreetly, like we see on mapping systems. The left veins almost always, we think of left comma as being a rarity, it's not. Most of the time, the left veins have some point of convergence before they branch out, and that becomes relevant when we're trying to get complete isolation and maintaining contact. So a visualization of the left atrium, and then we navigate, confirm contact, and ablate. And it's always that sequence of events. We navigate in 3D, we confirm contact, and then we ablate, and that is the sequence. So we go very coordinated from the left superior pulmonary vein to the inferior, we move to the rights, and then the posterior wall is the last step. So just so everybody's in agreement with what we're looking at, this is what an endoscopic view of the left veins look like and I'm gonna go backwards and replay this. So you'll notice in this example, there is a carina that separates the left superior and left inferior, but that's not always the case. These are how the veins are splayed on the left. Why this is important is because we've seen from the literature that the anterior superior aspects of the veins show the highest point of reconnection, and the reason for that is that sometimes you don't get perfect effacement of the ablation catheter in those areas, and those areas tend to have thicker tissue than other areas circumferentially. So it's important to hit those. So when I navigate the ablation catheter, I am putting extra lesions in those areas intentionally. And then the right veins, they look beautiful. The image that you get of the rights are really nice in 3D. And again, sometimes I'll put the ablation catheter more anterior on the right superior pulmonary vein to really hit that area hard, and I can do that because I'm directly visualizing. Now, as we have seen in the live case, biplane is key. So I'm always leveraging orthogonal planes, and you'll notice I don't have much experience with pulse select, but I can tell you using the pentaspline catheter, the stalk of the catheter is pretty thick and it's echogenic. The sonographer can really cleanly drop those plumb lines to make sure that you're following the center of the stalk to get a perfect orthogonal plane. And as you can see here, I can see the petals very nicely hitting circumferentially. That's really important. Why contact is important is because also there's a lot of literature that shows that even a couple millimeters of offset will decrease the depth of the lesion. You don't have to put a lot of force when you're making contact, but you do have to make contact. We know that not only that translates into more durable lesions, but less hemolysis. So assessing contact is super important. And here is just a very short clip to show what a pentaspline catheter looks like. I always use a live 3D image to navigate. I do not leverage mapping almost at all. You can see the mapping system we've hardly built out a shell. So I'm really leveraging 3D for navigation purposes. And then once I've got the catheter positioned in the area that I want, then I'll do the orthogonal planes and then ablate. You can see on the fluoroscopic image here that I haven't even hit fluoro since I've crossed over. I don't need to. Once I've got assessment of contact using 3D eyes, I don't need to use mapping and I don't need to use fluoro. So it really takes that leap of faith. You can start the case off with all of these redundant imaging technologies, but once you start to understand that what you're looking at is real time, you don't need to leverage other images to tell you where you are and whether you're making contact. Why we live in this era of false reality is this. This is a live CT scan. Eventually this is gonna get to the left atrium, but on the right hand side, these are all of our mapping technologies. It shows a static image of the left atrium. This is not reality. What reality is is that the left atrium is constantly in motion. And as you get closer to the annulus, it's hyperdynamic. We just don't get that level of spatial temporal resolution from a mapping system yet. And because of that, having live 3D, it just makes it much more easier and much more accurate to navigate catheters. So my two cents in this matter is that once you get over the hurdle of A, putting ice in the left atrium, and B, using it full faith in assessing where you are and adjudicating contact, it really becomes such a pleasure to use as an adjunctive technology. Now even more relevant in the era of concomitant PFA and left atrial appendage occlusion. Great, and that is all I have, Shep. Yeah, I just wanna bring a point to you guys to discuss. I mean, if you look at our European colleagues, they become very comfortable doing ablation without intracardiac echo. They do angiography of the veins. They don't map. They do fluoro and angio. And I feel like in the United States, if you were to take an electrophysiologist and say, listen, I'm gonna take away your ice catheter, will you do an AFib ablation? Or I'm gonna take away your mapping, will you do, but you can keep the ice. Do you think more people would say I need the ice? Because if you come in on a day and the ice machine's broken, or someone took it and you have no ice, would you be able to do an AFib ablation comfortably? Or is ice, where does ice fit in that? I mean, I think it depends on what therapy you're utilizing, right? So the intention of 3D mapping was first to help us gain efficiency in navigation in a point by point world. The iterative development of voltage and lesion assessment, et cetera, was to drive outcomes afterwards. And it's specific to point technology. I think when we get to single shot technologies, whether that's cryo-balloon or now PF solutions, as Kevin highlighted, the most important thing that we need to do is understand apposition. And since many of these technologies, at least in the US right now, are single shot, we don't necessarily need the precision, three millimeter precision of navigation for these technologies like we did for point RF. So I would be much more, I think it would be much more difficult to have consistent outcomes without an ice solution. You could have just said yes and answered the question. No, I gotta tell you why. And then you said, okay. Kevin, would you agree, without ice, would you do an AFib ablation case? So my answer is, take away mapping, I'll be fine with ice, and for a couple reasons. We're the same vintage. I learned how to do a transeptal under fluoro and injecting contrast. If I really wanted to, I could get back to that. But we live in an era, especially as these procedures are moving outpatient, I want instantaneous assessment of pericardial effusion. I want that guidance, real-time visualization of guidance. I would leverage ice over a mapping system any day. Okay, fantastic. So next topic we're gonna talk about while they're getting ready to do the appendage closure is gonna talk a little bit more about optimization and the concomitant workflow of the two procedures as we see a dramatic uptick in the rate of concomitant procedures, primarily because there's payment for this and patients wanna have it. Thank you much. So to riff on the earlier comment that you described, Shep, I think we're 100% focused on what is the best workflow that has the optimum outcomes for the patient that can deliver for the facilities that we work in, especially as it relates to resiliency of the staff and coordination with multiple subspecialties, whether it's cardiovascular imaging, anesthesia, et cetera. And then we definitely need to be increasingly aware of the cost of the procedures. Again, in light with the technological evolution with ablation. So if we looked at our current state, what we see is that many practices will utilize of the graphic workflow, which includes a graphic on the left. So T-guided left atrial appendage closure, which requires an anesthesiologist in the US and imaging physician in most cases, along with the interventionalist and then several techs and nurses. That certainly results in more difficulty in scheduling cases and higher total room time, as well as higher turnover times. If we think about how we make the transition over to 3D ice guided, we often think about going in a stepwise fashion where we'll lean on an imaging cardiologist, much like Ricardo has shown us today to help guide implants and help us develop an understanding of the echo images that we're seeing. Hopefully the idea would be that after we've built that partnership and we've maintained the requisite competencies that we can then as an individual operator be able to perform the implant as well as the imaging, limiting the total amount of staff, limiting the logistical hurdles of scheduling patients and of course, shortening the total room times as well as the turnover times. If we were to break down some of the available data around how ice guided workflows impact lab efficiency, this is about what we would see. So in most studies, we're gonna save about 30 minutes and an average procedure cost will be reduced by about $2,000. Some of this is based upon older 2D data as well as a resourcization process. So certainly if we're utilizing newer catheters that are not re-sterilized, that cost savings may not be prevalent. We'll certainly see a decrease in pharmacy costs if we're talking about a LAA standalone procedure that's ice guided. With concomitant, I think most of us are using GA and so the graphic on the bottom right probably doesn't apply if we're talking about truly concomitant procedures but in standalone workflows, we'll also see hospital cost savings for PACU and bed utilization mirror that catheter cost savings around $2,000. And then we'll see an uptick in same day discharge to the tune of 35 to 50%. So I think as we all recognize that when, in the next year and a half or so when we get the results of Champion and Catalyst soon after, we'll see an explosion in the indication hopefully for left atrial appendage closure as a primary strategy for stroke risk reduction. Certainly, Shep, as you described with the CMS statement for concomitant coverage, we have reimbursement to help care for these patients in the same setting. And then naturally as the awareness around AFib and AF ablation takes off, we're gonna have projected increases in ablation volumes that are approaching 20 to 25% per year. So we have to understand that with this onslaught of procedures, we have limited resources, we have to manage the scheduling complexity, we have to consider the economics, and we have to put safety and efficacy at the top of what we do in changing our legacy workflows. So just in brief, I'll talk to you about what is probably the largest cohort of concomitant data that we have thus far. This is all from the National Inpatient Database from 2016 to 2020 in patients undergoing left atrial appendage closure combined with any other cardiac procedure. And you can see in the blue portion of the pie chart, 73% of the concomitant procedures were ablation. That makes sense that we would be combining ablation and left atrial appendage closure. It still represents a very small portion of the total number of closures that were done over that timeframe. So of the nearly 88,000 closures, only 1,200 had combined cardiac procedure. And if we were to break those down a little bit further, what we would see is that compared to left atrial appendage alone, concomitant left atrial appendage closure is not associated with any difference in in-hospital mortality, stroke, major bleeding, length of stay, or major adverse cardiovascular events. In fact, if we dig even one step deeper, which this data was shown in 2018, what we see on the European side is that there are very few events and the seal rates are exceedingly high. And then finally, I'll show this. It's last year, John Puccini had an abstract that looked at the SURPASS database. Again, about 1,300 concomitant closures with a higher compression, better seal rates than those individuals who were undergoing standalone procedures. So we know that this is a safe procedure when completed as a standalone, as a standalone with ice. And we certainly know that in the data that we have right now through these registries that in a concomitant fashion, it has equal safety, probably better seal rates because of how we choose the size of devices. And maybe I'll close on that and ask both of you how you guys change your sizing parameters as we kick it back over to Ricardo. Yeah, I mean, I think a study that we didn't mention, which probably is the most relevant now is the OPTION trial, which was presented in November of 2024 last year at AHA, which randomized 1,600 patients to getting AF ablation and staying on anticoagulation, which is primarily eloquence versus AF ablation with concomitant that is at the time of procedure appendage closure or within three months sequentially with appendage closure and then following these patients for three years. And I think the one thing that was clear was the safety of the combined procedure. When you see how low the MACE rates were, it was quite impressive. As a matter of fact, there was no difference in safety if you did them concomitant or if you did ablation alone. And if you broke that down into the group that got them sequential versus at the time of concomitant, then there was also no difference in safety. So I think based on the data you showed and the randomized data, which again was done in the days of radio frequency compared to PFA, I think the field is getting very comfortable in the safety of doing them together, which I think as you mentioned, and I know Kevin, you can comment, we find that we tend to upsize the devices in the ones that we're doing ablation and which probably lends itself to better seal. But that necessitates doing the ablation first and putting the appendage closure device at the end. I'm interested in hearing your opinions on one versus the sequence. We know the heart rhythm paper that just came out and the image, the inset image was striking. I mean, 69% expansion of the thickness of the ridge in some cases, that's a lot. I've never seen that, but nevertheless, what's your feelings on order, sequence? Well, I mean, the limitations that I feel in terms of doing appendage closure, regardless of the sequence, is having a device that's not gonna be near the ridge. So that pulls me away from a two component device into a plug that kind of goes a little deeper in. Because just like we see edema with radiofrequency, it's unpredictable. There are patients where you see substantial edema and others where you see minimal. But I tend to choose the device based on the size of the pre-image. So I don't do TEE prescreen because I'm gonna be in the left atrium anyway. So I go across with the left atrium with ice, measure with ice, pre-ablation, and then look at the measurements post-ablation versus you could TEE. If I was only doing a standalone, then you could say I'm only doing an appendage closure off-screen. But if I'm gonna be there for the ablation anyway, I'll look for them. So you're doing measure first, ablate, and then appendage. That's right. Is that your sequence? Yeah, we're doing essentially, and we measure a second time. and largely that's to account for some of the inflammation that may occur. I agree, I don't think that we want to short sight the potential complication if we place the closure first and then don't have enough real estate to ablate, you know, on the interior side. I'll tell you from a practical standpoint, I've had arcing from the pen to spline and not being able to deliver any energy if you get close, so you potentially could leave that that lateral ridge unablated too. We're gonna cut back to Nashville as we're gonna now focus on I think the most powerful part of volumetric imaging which is being able to do the appendage closure, again leaving the catheter in one location without multiple manipulation. So go ahead, if you want to show us what your angio look like, we have about 15 minutes. Yeah, let's play the angio of the appendage and if you could go back. And I love the conversation talking about safety and efficacy of these procedures, standalone, combined. You know, one interesting safety component to this that I don't think any of you guys have touched on yet is, you know, some of the registry data has shown that there may be an increased complication rate with pericardial effusion when left atrial appendage occlusion is done with ice. And I just want to take a second and talk about that because I feel like not every ice catheter is made the same. Some are stiffer than others, some are much stiffer than others. This catheter, Verisight, it is the, I think, the safest catheter out there. I think that you might get a little frustrated. Can you tell us why you're doing that for the interest of time, just the images, because the audience hasn't necessarily seen a lot of the 3D ice imaging in terms of what you're looking at and what planes and angles. Here's your image. We're looking at the multi-planar reconstruction from the body of the left atrium. And just from one view here, they've been able to kind of look around and see that our measurements are pretty similar to what we had before. The NGO shows similar to what we were expecting on the CTA, a windsock. Was there much change in the dimensions of the appendage pre- and post-ablation? Did we get any difference in the dimensions? No, as a matter of fact, we didn't see any changes. Okay, and your ice is sitting where, would you call it mid-atrial or what would be the position? Here, I'll show you where I am on ice right now. Yeah, so it is almost kind of posteriorly flexed, kind of at the bottom of the atrium looking up, and very dilated atria sometimes. This can be a very big distance, and so I've found in those situations the super mitral view gets you a little bit closer. But this very closely resembles TEE here. I think that's the salient point that you made. The tech can do everything. It does resemble TEE. If you were to have a 2D ice catheter in this location, you'd have a left-right invert, superior-inferior inversion, everything is flipped over. But if you're used to TEE imaging, you look at where that catheter is, yet the volume of data you can adjust so it looks very similar to how you'd be looking at TEE. All right, I want to chime in here exactly, as you mentioned, with having the NPR live, this system is exactly similar to TEE. So I can create traditional 45, traditional 90 degree, you know, going to reversal 135, and if I just rotate 360, I can see exactly at our virtual ostium. So that's the, and also we can make sure that we don't go through any, miss any of these crits down. So that's the beauty of having 3D NPR. So how did you rise, you know, watchman there? So the good thing is that with this, we measure three different numbers, you know, which is kind of representative of 45, 90, 135, and then these numbers represent the same numbers that we get usually by 3D, by TEE. So we don't have to just say that this is a three, zero degree, which is correspond to 45 degree, or 90 degree, corresponds to 135. It doesn't matter. Now we have completely new system that we just measure three different numbers, and I don't care about the degree of it, as long as I can get a very crisp images without having no blur one. So for instance, you see that this is a blur one. In order to get rid of this, I will just go there. So now I can see, you can see that this is exactly coming, both of them in the, in the non-red zone for us that has a lowest spatial resolution. So what size watchman do you have loaded up there, based on your instruments? So we have a 31. And what was your largest measurements? Largest measurement was 26. So, would you guys agree with this, 31 on a 26? Would anyone else go with 35? I think probably in our center we would have gone 35. We have enough judgment. I probably would have done a 35 too, just get a longer device. But you know, we're usually wrong on the podium, so. Yeah, we'll see, we'll see what it comes out to be. So let's go live, and let's deploy this, and you know, the imaging is so clear here, I think I have enough confidence to say that I can deploy this without needing to depend too much on FLORO. It's a big advantage. But I'm gonna do a little bit here. Yeah, you can show us FLORO, just so the audience can see how the two compare. And we have enough depth. We measured the depth, it was 49. And there we are deployed. I'm gonna hold a little forward pressure here. I haven't even had to touch the ice catheter. It's got a little bit of compression there. Now I'm gonna go ahead and tug on it, and we'll just do our tug under ice out. I may have, just a hair there. Push it back into place. And can you do a Cine contrast injection from the sheets, so we can see that? That would be nice. Yeah, so there you can see I'm doing my tug test on ice there, and you can see it's locked in good. Okay, so let's get a tiny little shoulder there on one angle. So the inferior aspect on the mitral edge. That looks like you have a lot of depth there for the device, so it shouldn't be an issue. Yeah, that contrast definitely hung up in there nicely. I guess he was right again. Let's see, how does this measure in terms of compression? Yeah, the way that we do again, the same thing, 360 degrees. So I just rotate in the left lower, which is an on FOSS view, as you see. So this image, this is a correspondent to the surgeon's view or EP view, I would say. So this is an on FOSS, and this is correspond to, for instance, here, let's say that zero degree and 45 degrees. So I do 360 first without measurement to make sure that we've got all of those, all of those crepes, and make sure that we don't have enough shoulder or a lot of shoulder. As you see here, a little bit on this side, we have a shoulder. It's a small shoulder on the mitral edge inferior. Yeah, we can measure it a little bit to see that, make sure it's not more than one third of the height. So we have kind of like seven millimeter of shoulder in this view, and then. Actually, I prefer having a little muffin top as a closure versus completely flat to allow for, you know, good contact. 360 degree. I think for those in the audience, you know, for those of you that are used to TE, you don't have to relearn this technique. You can get TE-like views and have a view. And the way we've kind of addressed that is it doesn't matter where your catheter is. It depends on what you see. If you see the aortic valve in the appendage, and that's a low angle view, whether that's 30, 40, 50, something in that range. Sorry, I couldn't hear you very well. Oh, no, I'm just talking to the audience. Give me one more minute. And then if you see the mitral valve and the appendage, that's your mid-angle view, 70, 80, 90 degrees. And if you see the PA in the appendage, then that's your 120, 130, 140 view. So that way you don't have to relearn everything and continue with what you know with TE, especially if you're doing pre-imaging or post, you can compare apples to apples. So what are you getting measurement-wise there? So far, what do we have compression-wise? So far, we have the largest. Actually, I will reconfirm it again by 2D. But by 3D NPR, the numbers that I got was the maximum was 26 to 25. Can you show us some 2D measurements there? Correct. And maybe you can make that 90 or 45 just to get high resolution there. There you go. So what you'll notice on the ice catheter and why we keep saying go to 45 and 60, as you start going over 60 degrees, you recruit less elements and your aperture changes, so the resolution will drop. Now, that often is still good enough to what you need, but if you stick to that 60 degrees on both sides, you'll have much higher resolution. You'll have much higher resolution of the image. But you see he's able to spin all the way around and see the catheter. And this is typically the views we like to work in, which is in biplane. Would you say your technique is very similar to what we're doing here? Kevin, are you doing more NPR measurements versus biplane? Yeah, I think that sort of helicopter technique of dropping the line and just going circumferentially around is very helpful. Anish, any difference in terms of your technique? No, I mean, I think we rely on the NPR. We also go back and, as you said, we try to get our three distinct views in the low, sort of medium, and high angle just so we have great resolution. Yeah, this is pretty consistent. I think that's an important point. If you're going to forego a TE, it's good to get facile in the kind of three different approaches of assessing the appendage. I think we're really happy with the compression that we've seen so far. And just to be clear, you haven't moved the ice catheter here, right? It's just sitting there. My hands have been off the ice catheter. I touched it once when I backed the sheath back to the tug test. That was the only time I had to touch the ice catheter. The rest has all been our echosonography team. And that's a really powerful point for people who don't miss that, that the catheter has been sitting in one location and the operator has been able to focus. That's going to help with operator comfort and also just learning the technique by being able to leave the ice in place. And it looks like the device has already expanded a bit, huh, compared to when we put it in. Have the measurements changed at all in your view at zero? Have the measurements changed at all? No, all of them. The measurements have been pretty consistent. I've been seeing a lot of 2.48, 2.56, 2.62 was the most. Yeah. So are we meeting the past criteria? Are we planning on releasing? Assuming, I hear that everything looked good on color. Did we complete the full color? Correct. Yeah, we did by 2D, yes. And as you know, I think maybe the Oculus pins... So, yeah, I mean, I like that analogy of the muffin top. I think that's great to have that amount of device, that amount of fabric sticking out. That way you don't have a static area where thrombus can form. So maybe one quick question from me. In your concomitant cases, what are you choosing as the duration of anticoagulation? I think that's a great question. You know, I'll tell you a really unfortunate anecdote. I had a patient recently who, he did not tell anyone that he did not have his anticoagulant. I'm not sure what exactly the situation was, but he went home, and unbeknownst to any of us, after his... It was a standalone PFA case. It was not a concomitant. He unfortunately did experience a stroke the next day. And so I know there's a lot of debate, especially with PFA. You know, is the endothelium okay? Is it fine? I'm still erring on the side of, you know, two months of anticoagulation, and not cutting it off at six weeks, just to allow the tissue... Your point is well made. I mean, just to be clear in the audience, no academic talk has ever been given to say, with PFA, don't anticoagulate. So that's not anywhere in the field. No one's saying that. No one should be saying that. The question really is, are you going to go two months, three months, four weeks? I think that's really what the debate is. And it really depends. I think most people are doing at least a few months of anticoagulants, and then switching to antiplatelets with the appendage closure. So it looks like you meet your past criteria. Yeah. They're doing one more round of compression measurements just to make sure that the device hasn't moved at all. So speaking of muffin talk, Dr. Amin, do you find... Would you say you were wrong with the sizing in the 31? Was that a good choice? So, you know, for us, we do aim for higher compression. We're usually trying to shoot in the 25% range with our concomitant cases. So I think this has been a successful case. Our personal preference is to have a little bit more robust compression. Yeah. I think it was an ovoid OS, and if you had a 35, it probably would extend to that inferior gutter and cover that. So you probably had a little more depth if you needed to put the 35 in. Exactly. But we like this. Which was 19. With 19, it would have been kind of like 40% compressed. So that's why. It looks beautiful. Well, we can give protomy at this point. Okay, you've released the device. So kind of tell us a summary of what you've done, the number of applications you've applied. So, yeah, basically, just to summarize this case, a gentleman who had paroxysmal AFib, kind of starting to approach that early, more advanced persistent phase. PFA with pulse select, a little 32 applique for vein, and then before removing equipment from the left atrium, including the left atrial appendage here with the Watson Flex Pro. That's a nice image there. And we got a beautiful result for this patient, really, I think, facilitated by the Varisite ice catheter. So really appreciate you guys joining us and giving us the opportunity to share this. Great, thank you. Great job. Great job. And thanks to the team for doing a great job. So we have a few minutes to kind of discuss a few things. And I'd love to hear from the two of you up here on the podium, what has happened and changed in your workflow? And when are you offering concomitant? Now that you have the technology to do this with ice, not needing another TE physician, has that swung the pendulum a little bit in terms of when you're offering concomitant? There's the offering an appendage closure when someone gets referred for an ablation, but also offering ablation when someone gets referred for appendage closure. These are unique facets that electrophysiologists can do that interventional cardiologists that do the implants cannot. And so this is a very interesting position we've come into the space now, where EPs always say, well, why are ICs managing AFib? That's an EP thing because we have other things we can offer. And they may be very good at structural implants. So I'd love to hear what's happening in your institutions. Yeah, I think the emergence of the option of concomitant management, I mean, it's like a switch that has been flipped on because when you offer the possibility of that, it's like an instant yes from the patient. So I think it's more the value add of adding appendage management to a patient going for ablation I think is a much easier sell. Whereas somebody who wants to get off anticoagulation to throw as a value prop will also manage your rhythm. I come across less of those cases. So that's interesting because I have the opposite experience, that when patients are being referred for closure, they're expecting an implant. And when we counsel them on the potential value for an ablation, because there's no additional embedded device, they're often very open to it. When I've met patients who are getting an ablation and we're discussing closure, they're like, wait a second, you want to implant what? So it's interesting that in different communities we've had different... So to that point, what's your experience been with the added talk track that you have to do? Because it's a different informed consent. So does that become an obstacle for you mentally when you encounter patients? That's another piece of this, the logistical portion of it, the shared decision making that has to take place. So those who are being already referred for closure, we've got them in the workflow. You can very quickly sort of add on the conversation around ablation. The other way around. The other way around does add some logistical challenges. For us it really hasn't because it's rare to find a referring doctor who is a general physician suddenly have a difference of opinion from what the specialist is recommending, at least in our practice. So if a patient comes to us with paroxysmal AFib for appendage closure, many of them think the watchman is going to fix their AFib. We have to explain to them, no, no, we're not treating. So there's a lack of understanding sometimes, and if you tell them, look, while I'm there I can do this, and then that becomes an ethical decision that, let's say you can do an ablation and 50% will be efficacious, even if it was as horrible as 50%, if you can do it safely and half the patients will stay in sinus rhythm and they're symptomatic, you have to decide whether it's worth it. And a lot of our patients that are referred for watchman have symptomatic AFib that's in some control because they're on flecainide or they're on amiodarone. And knowing the risk of anti-hypnotic drugs, I feel like it's ethical to say I'm already there should I consider ablation. And most of the time when I reach out to the primary care physician to say, hey, listen, while I'm there I'm thinking about doing concomitant, it's been a very easy talk track. But you're right, I think you do have to manage patients' expectations and it will vary depending on patients' level of education, understanding of the procedure, because many patients feel that if they do an ablation they're going to get off anticoagulation on the other side. Oh, you're going to do this so I don't have to take blood thinners anymore. So I think it can go in both directions, and this is the value proposition I think that EPs can provide. In a center where interventionalists and EPs can work well together to do this. So with that, we have reached time, exactly at 1.15. We want to thank you all for being here. Thank you, Phillips, for putting this session on. Thank you to everyone that's in Nashville, the whole state, the city of Nashville, for putting that on. And thank you to the two of you. So with that, have a good rest of the meeting. Thank you.

iRhythm

Heart Rhythm Society Meeting

cardiac procedures

left atrial appendage closure

pulse field ablation

3D ice imaging

atrial fibrillation

electrophysiologists

interventional cardiologists