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Real World Evidence on the Role of 4D ICE Imaging ...
Real World Evidence on the Role of 4D ICE Imaging ...
Real World Evidence on the Role of 4D ICE Imaging in Concomitant PFA and LAAC Procedures
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Well, welcome everyone to the first Rhythm Theater session for HRS 2025. I'm Devi Nair. I'm one of the cardiac electrophysiologists in Jonesboro, Arkansas. Today we will be discussing about real-world evidence on the role of 40 ice imaging in concomitant PFA and LA closure procedures. And I want to take a minute and thank Siemens for putting this Rhythm Theater together. It is a very important topic, especially as we start to hear the results of option trial, as we start doing more concomitant procedures. We have a DRG now for concomitant procedures. And I think it is important for us to discuss as a group, as a field, how we can do them safely, efficaciously, as well as efficiently. So I have a great panel with me today. I have Dr. Kevin McCarty on my left. Dr. McCarty joins us from Tampa, Florida. And I have Dr. Adnan Kazer from Michigan. And they'll be taking over later on with the Q&A. So to kickstart the program, I will start off here. And I'll start with just giving a procedural kind of workflow. I'm going to stand up. I can't do sitting and talking. All right. So I'll start off just giving a little bit of what my procedural workflow is when it comes to doing a concomitant procedure. And today, almost, I would say, 99% of our AF ablation procedures are with a concomitant procedure. So we have a lot of AF ablation procedures are with PFA. And that's the workflow that I will show. These are my disclosures. So just to introduce the technology, as far as, you know, I remember as a fellow, you know, I started using ACNAV. And it's come a long way in my mind. And what you see on the far right is 2024, the Lumos catheter, which is the 40-ice catheter that is what we're going to show today and how to use the Lumos catheter. Now, the beauty of the Lumos catheter is that it has a 90 by 54 field of view. It is a 12 and a half French single-use catheter with a 90-centimeter insertable length. It does allow for 2D and 4D beam mode volume, as well as color Doppler volume. It does allow for Doppler as well, both pulse wave and continuous Doppler. Now, let's talk a little bit about concomitant procedures. And I think each of us might have a different viewpoint about it. But, you know, as a proceduralist, when I think about a concomitant procedure, I'm thinking about this patient's only going to need one procedural axis. You know, there's reduced procedural time in a sense. You know, of course, if you are thinking about just the ablation or just the appendage closure, it's different. But if you think about two separate procedures and combine them, it's definitely a shorter procedure for the patient and for the operator. The sedation, the anesthesia aspect, there's things that we need to talk about. It's more streamlined for the patient from a recovery standpoint, less recovery. And to me, you're bringing everything together in AF management. You're bringing the arrhythmia prevention as well as stroke prevention together. And from a patient standpoint, I think most of the patients, when we talk about concomitant procedures, the only thing they ask me, if you feel comfortable doing it, then please get both procedures done at the same time. Because it gives them an opportunity to have just one procedure. And then you have the potential of maybe cutting down on the oral anticoagulation regimen probably two to three months after your LA closure implant. And from a workflow efficiency standpoint, we have a DRG thankfully now, so we can actually do them without having big financial losses. It does allow for optimizing resources and potentially decrease radiation exposure for our patients. So when I think about the workflow for a concomitant procedure, I start off with putting my ice catheter and sheath into the LA. I like to get some pre-LA imaging before I do the ablation. And then I'll do my PFA. I'll come back and re-image because I believe that I want to see what the LA looks before and after I do my PFA. And then we move on with LA closure. Now to me, when I do a PFA, I like to put my ice catheter in the left atrium, whether it's 2D or 4D ice. And I believe that we know that contact assessment is extremely important for PFA and for durable PFA. So that is how we use it. And you can see 4D ice gives a great real-time assessment of contact from the left atrium. Now, depending on what catheter you use, you can use a circular catheter or a pentaspline catheter or a variable loop catheter. It does give you a really good definition of what that catheter looks like and how it projects, especially a three-dimensional orientation of that catheter, and allowing you to know how well you can overlap. Now, when it comes to LA measurements and such, you get the potential of doing your sizing. You get to position the device and do your pass criteria or your close criteria, whichever device you're using to assess for seal. Now, when it comes to LA measurement, 4D ice obviously has an advantage. It has the advantage of giving you those NPR measurements early without having to manipulate the catheter too much. And then, of course, looking at device position in a more three-dimensional fashion, so you don't have to worry about leaks and such and missing a plane that you might miss with 2D platforms. Of course, one of the biggest things is making sure that you implant the device appropriately and optimally at the time of implant to avoid things like peri-device leaks. In post-implant assessment with a 4D ice catheter is extremely, extremely easy and I would say very, not just easy, very safe and efficacious. Looking at seal is, again, color Doppler in three dimensions is extremely valuable as well with the low Nyquist limits. Again, with the same, you can see the device position, you can see the cant of the device, etc. So, let me just show you a quick edited video of a case that we did. We tend to do CT pre-planning with the 4D ice. I've kind of moved away from it sometimes, but again, you know, I get two access points in the right side. I usually do pre-closure. You can see I'm using a pentaspline catheter today, a Farrapulse catheter today. So, I tend to do my transeptal where my appendage closure needs to go. So, I look at my LAA and pick my transeptal site. I look for a nice coaxial location. In this case, we're looking at a more inferior kind of mid location. You can see I'm taking my ice catheter into the left atrium through that same transeptal and once I get into that left atrium, we'll get LAA measurements. We'll look at the LAA, get the pre-measurements, and now we're getting ready to do our PFA. And this is my standard workflow, whether it's a concomitant procedure or if it's PFA alone. I do my ice in the left atrium. I assess contact with ice and I look. I usually have a 3D mapping for my PFA to look for overlap. Now, you could potentially, if you spend more time actually, probably look at overlap on just the ice catheter. I like to have the pre-voltage sometimes. I like to map and have that extra set of, I guess, navigation tool to look for overlap and that's just been my practice. Now, it depends on, and this was a persistent patient, so the plan was to do PVI and posterior wall. And if it's just PVI, sometimes you could get away without mapping, but if I'm doing a posterior wall, I like to do mapping as well. Now, you can see on ice very clearly how the catheter, how the splines are in real good contact. You can see that the spline's kind of bending back. We're looking at the veins right now and now we're kind of going towards what we call the anchor lesions. We're using an insight system here to do the mapping alongside the ice. Now, you can see the ice showing the right inferior pulmonary vein. The right veins are usually pretty hard to see from the right atrium and you can see from the left atrium, the imaging is extremely good. Really shows you how coaxial your catheter is, whether it's a pentaspline catheter or a circular catheter. Now, once this is, again, a three-dimensional structure here, you can see the overlap of the PV and the posterior wall isolation. And once we've done with that, we'll look at our projection just to make sure we have enough overlap. If you are, you know, again, when the atrium is big, I tend to use mapping because it's just easier on me and I kind of make it easier on me most of the time, I have to say. So, this is the anatomy of the patient on the CT. You can see it's a chicken wing anatomy, inverted chicken wing, and this is the reason we kind of came more inferior and more mid to anterior on our stick. Now, you would see that on your pre-imaging as well, but I did the pre-imaging from the left atrium. So, this is a pre-analysis with a software called Pheops that looks at AI algorithms to predict what device might go there and the device that was predicted was a 20 millimeter device. So, you can see this is a measurement that we did before and we'll kind of look and see. We actually presented data that showed that there is edema with PFA in the LAA and you see up to two to four millimeter difference in the orifice and the osteal dimension. So, we like to do our measurements again and here you can see the angiogram of the left atrial appendage and you can see that chicken wing anatomy. I don't routinely put a pigtail catheter. I end up using the the loop of the versicross wire. That is my standard. I am using a steerable sheet. It's a true steer sheet that I'm using. I tend to use a steerable sheet. I'm a believer in steerable sheets. So, here you can see I'm entering the appendage in its 3D and I like to enter in the ball configuration. I don't usually go into the appendage with the device early on and I like to enter in 3D, enter the appendage, and then it's a really slow deployment with the steerable sheet deflecting down to allow for a coaxial placement. Now, you can see the first look at the device. It's got a, it's slightly maybe on the 10 to 15 percent compression but there's no real depth in that appendage to put a bigger device. I tend to oversize most of the time as long as I don't leave a big shoulder. So, in this case I feel like the device is appropriately within the appendage. You can see those RO markers. It's in the osteoplane. This is a Watchman Flex Pro device that we implanted and we're confirming the position and the seal with ice and our compressions for that matter. Once we go through the pass criteria, we'll get ready to release the device. We had a good angiogram and we will release where you can see the stability of the device and how well the device is sitting with the angiogram post as well. So, with that I'll summarize by saying that there's definitely a lot of advantages to having a concomitant workflow with 4DEyes. It makes the real-time imaging guidance extremely easy to assess tissue contact but also enhance visualization for your transeptal, for your device deployment, and then because of the high spatial and temporal resolution you get to assess not only your ablation, you could potentially in the future maybe assess lesion. We'll have to talk about that for future developments but also confirm seal appropriately and definitely allows us to, I don't use fluoroscopy for my ablation so the only time I use the fluoro is when I do appendage closure. So, it truly allows me to cut down fluoroscopy and allows for a streamlined workflow. With that I'll stop and pass it over to Kevin for his presentation. Okay, I am a hand talker like Debbie so I will be standing as well for this presentation. Fantastic presentation Debbie and great to see you. Thank you for the excellent overview of concomitant. So, I'm going to be talking about how to leverage 4DEyes with PFA. How many people plan on doing concomitant or already doing concomitant procedures? Okay, how many people are looking to use 4DEyes to replace mapping systems? This is why I'm giving this talk. Oh, I love this. Okay, you might be a forerunner. So, as we move into this era of hyper-efficiency with doing PFA procedures, it makes you wonder how do we get to minimizing the time that it takes to do a PBI and a concomitant case and the answer is by eliminating all of the unnecessary personnel and the steps and workflow to get these procedures done and I'm going to make an argument to you that you can do this case with just 4DEyes. You don't need mapping and I'm going to show you a little movie as to how we do that in Tampa. We've prepared a workflow that is in submission right now to show step-by-step so keep an eye out for this when it gets published. What are the advantages of 4DEyes? We went through an era where using PFA was thought to be not contact dependent. It was a field ablation. We now know that this is not the case. If you don't have tissue contact with PFA, not only do you increase the likelihood of hemolysis, but you decrease the durability of the lesion. That's a fact and as we do more procedures, we are now starting to appreciate the fact that we have to make optimal tissue contact. So, it begs the question, how do we do this very precisely? The mapping systems have the surrogates of assessing tissue contact, but it's not a direct measure like contact force like we're used to with radio frequency and so this creates a value proposition for using 4DEyes direct visualization. Here is a publication that was a year old now showing the amount of pressure you need and its proportionality to lesion depth. So, there is something to making optimal contact and providing pressure and I'm going to show you how you can do this with 4DEyes. So, the workflow is as follows. In order to assess contact, you have to put 4DEyes into the left atrium. There's no way of getting around that. This is a learning curve that has to be overcome and so to commit to this workflow means that you have to be able to do this. All of the slides and beautiful images that Debbie showed you require 4DEyes to be across the septum. I think in my experience, that was the biggest hurdle of trying to get this done, but it requires both the ablation catheter and sheath as well as the 4DEyes catheter to be in the left atrium. Then we use multi-planar imaging, which as EPs we're not used to. It's basically cutting in 2D section orthogonal planes of the catheter so you know in three dimensions that you're making contact. And then we're using 4DEyes as the navigation system. So, no longer do you need to use the mapping system. You can look real time at how the catheters are moving and I will also show you this. So, we're going to take this step by step. This is what I do first. I get transeptal access. I also leverage 4D to know exactly the inferior, superior, and posterior anterior planes, which is what 4D is meant to do. I then image all the veins and what you're looking at on the right hand side is the actual endocardial visualization. It's almost like an endoscopic view of the left atrium. It's amazing when you do more left atrial ice cases how different the mapping systems like to project the optimal image of the left atrium. You really get to see what the inside of the left atrium looks like as well as the takeoff of the appendage os and the veins. And it really is enlightening. Here are the right veins. Again, I can see this very clearly. I do not need to construct a map of the right veins when I can see it very clearly. The missing element is just being able to visualize the PFA catheter as it makes the interface along these veins. And here's an example of that. So, what you're looking at in the 4D image is the left superior pulmonary vein, the left lateral ridge, and the left atrial appendage. And you can see the relationship of those structures super clear. And then we are able to slice that area in orthogonal planes to be able to show precisely what the relationship is of those structures as well as the interface of the PFA catheter. And here is showing, again, how we apply orthogonal planes when we have the pentaspline catheter. So, you can see in the 4D image in the bottom right, I'm visualizing it on FOSS. And then the clinical specialist that's in the room is able to put crosshairs on the ablation catheter. And I can see exactly how the pentaspline petals are hitting the tissue. I don't need to hit fluoro. I don't need to see this on a mapping system. I can even do rotations of the pentaspline catheter in real time. And I don't need fluoro to visualize that or a mapping system to archive that. So, it's very powerful. If you commit to this workflow, it takes a time to commit to learn exactly what you're looking at, but once you've gotten over that. So, I want to show a very quick run-through of what we do. It is a six-minute review of the entire ablation. It didn't really take six minutes, but it's sort of the highlights of using 4D ice with PFA. You'll also see me arguing with the mapping, the mapper that happens to be in the room because they're insisting on me hitting fluoro to make sure that they know what they're looking at. I tell them, no, we see it in 4D ice. There's no reason to do that. So, you'll be able to see that too. Here we go. Okay. So, the first thing that we're going to do is get 4D ice across the septum. And you're going to notice I can do this without stepping on fluoroscopy. And the key here is to follow the wire that I've used for transeptal. You see it at the apex of that triangle. And with slight pressure, I've now entered the left atrium. You know that you're in the left atrium because it's a clear space, exactly what the left atrium is. And I follow the wire into the left superior pulmonary vein. I always park my catheters in the left superior pulmonary vein. That becomes my workstation where I can exchange sheaths without having to worry about creating a perforation. The next step, once I've parked the wire and the sheath in the left superior pulmonary vein, I then immediately start ablating. There's no construction of a map. I don't have to wait. I can immediately see it on 4D ice and you can see the artifact on the recording system that I've just started ablating. There's no reason to create a map. In fact, on the bottom right-hand side, you see the map and it's very rudimentary. I'm not even looking at it. It's there as an archive, but I really don't need it. I can leverage 4D ice completely to make sure I'm hitting all the planes and making contact in conjunction with a recording system and using 4D ice. I have the fluoroscopic image if I need it. Just to give you an idea for this case, it took 1.3 minutes of fluoroscopy. It's not zero fluoro. It's darn close. I use it as a comfort measure, but 1.3 minutes of fluoroscopy with 30 or 40 milligray of radiation is essentially a zero fluoro workflow. Now you're seeing manipulating the catheter. I've completed the left superior pulmonary vein. Now I move to the left inferior pulmonary vein. I know exactly what the left inferior pulmonary vein looks like because of the takeoff as it goes around the descending artery. Only the inferior vein does that. I know immediately I'm in the left inferior pulmonary vein and I can immediately use 4D ice to then go between basket and pedal. again, every time I'm ablating, just before I ablate, the clinical specialist is dropping crosshairs along the shaft, the long axis of the PFA, the ablation catheter, to ensure that I'm making contact. You will get no better assessment of contact than looking at it in real time. Everything else is a surrogate of reality. That's just it. Even fluoroscopy, and I'll show you an example of that, as we are all taught of looking at the deflection of the pedals on fluoroscopy, no, it's not as accurate as looking at 4D ice. And it's amazing, once you start doing that, you see, here's my mapping specialist asking me, hey, please, would you hit on fluoro so I know where the pedals are? And I hit on fluoro, and you can see in the video of me, I'm pointing and laughing at him because I told him, I'm not learning anything with fluoroscopy here. I already know what I'm looking at. This is the power of using 4D ice. So I continue to ablate. Now I've got to move my apparatus over to the right veins. And to do that, I just use real-time visualization in 2D. I put the ablation catheter in pedal configuration, and I am walking it across the posterior wall. It is atraumatic, and I'm literally watching it, so there's no risk of damaging any delicate structures or causing a perforation. And I walk it right over to the right superior pulmonary vein. I know it's the right superior pulmonary vein because you see the SVC, and so that's the landmark that tells me I'm on the superior end of things. And then I go down to my routine, move in 4D, orthogonal planes, ablate. That is always the workflow. Move in 4D, orthogonal planes to assess contact, ablate. And I don't have to do anything more than that. So here I've completed the right superior pulmonary vein. You can see on the mapping system I haven't even built out the map, the geometry, to know where the right superior pulmonary vein is. And yet I've already started ablating. This is the time-saving function of using real-time ice. So here you see the artifacts of PFA. I start, continue the ablation. And then in a moment, we will see that the mapper is getting frustrated because they don't know where in space the catheter is. And so we'll continue to watch this as I continue. I can do all this rotation. My mapping system specialist begs me by telling me, please hit fluoro. Let me see where I am. I tell him we really don't need it. And then the final completion here is the right inferior pulmonary vein. And the question to you all is, we know this fluoro image. Am I making contact? We're all taught that if you look at the deflection of the petals, I must be making contact, right? Wrong. I can see on 40 ice that there is a space between the inferior pulmonary vein along the posterior wall where I am not making contact. Despite the feedback that I'm getting from fluoro, this is why I don't rely on fluoroscopy. It is a surrogate of reality, whereas where I look at ice images, I can actually see where I'm going and I can see the interface around the os. There's nothing better than this. And so I hit on fluoro again, and I'm also laughing at the mapping specialist. You can see that in the video. The petals have to be farther back, but there's no way for me to make this assessment on fluoroscopy. I can use 40 ice to assess contact very effectively. I can continue the ablation. And then the last part of this, I can not only do a PVI, but I can also do a posterior wall. Now you don't have the archiving function of the mapping system to be able to tell you where you've been, so I use the recording system to sample electrograms. And I literally look at the posterior wall. You can see in the 40 image that the petals are moving with the heart. That's the perfect assessment of contact. And then I use my orthogonal planes to make sure the petals are making perfect contact. And this is an optimal method of ablating the posterior wall as well. And I walk around and look for electrograms, and if I feel like I have to do some redundancy, I don't worry. The issue of hemolysis is ablating in a blood pool. But when you have a sink for electricity, you don't have to be as concerned. This is not borne out with data, but this is just my prediction. So in conclusion, there's a lot of potential for ice. I use i40 ice for AF ablation. I use it for RVOT PVCs. You can really leverage 40 ice for looking, assessing contact when you're using ablation. It's a very powerful tool. And I'd like to conclude with that. Thank you for your attention. Our last speaker is Dr. Adnan Kassir from the University of Michigan. And let's hear your last session here. All right. Thank you so much. All right. All right. Thank you. Let's make sure this is working. All right. So I'm Adnan Kassir. In full disclosure, I'm a structural heart international cardiologist. I'm going to talk about the feasibility and safety of 4D ice guided left atrial appendage closure. And this is also in submission. This is my experience where I was in my previous practice at Mercy Hospital in Springfield, Missouri. So as we have heard already, so left atrial appendage closure is commonly performed under multimodality imaging, mostly with TE guidance. However, ice is upcoming. And the Aquanav volume 4D ice have showing images of the left atrial appendage, as we've seen earlier, that is phenomenal. And I've used this catheter in my institution and I had great outcomes. So this is my study. I started in the summer of 2023. I was having a lot of logistic challenges with scheduling TEE for my left atrial appendage closures. And so I decided to switch primarily to ice guided, mostly using the Aquanav volume 4D ice. And the aim of this study was to evaluate the feasibility and safety of treating all comers patients referred for left atrial appendage closure using this methodology. So all comers patients, like we said, between July of 2023 and September of 2024 were included. I had 80 total cases with 72 performed using Aquanav 4D ice imaging from Siemens. And all of my patients received prescreening using a CT scan or a TEE. This is the baseline characteristics of the 72 patients. I had about 42% were females and pretty typical hypertension, diabetes, MI, paroxysmal if it was about 67%. Now, left atrial appendage closure indication, just as we usually see in regular practice, most of the patients had a history of bleeds and some patients had recurrent falls and some patients were non-compliant or had lifestyle changes. So this is the primary outcome, successful ice guided left atrial appendage closure prior to discharge and discharge within 24 hours of the procedure. And then we looked at the safety endpoints, free of major adverse cardiac events, rate of significant pre-device leak, rate of device-related thrombus, and cessation of anticoagulation at 45 days. So this is the outcome, 97% successful implant, 72 cases. I had two cases where I could not successfully implant the device. One of them was I could not get the ice cross into the left atrial and one of them had issues with the watchman, I could not deliver it. 100% of the patients were discharged in 24 hours. Mase outcomes, I had one patient who had one possible non-disabling CBA event a few days after the procedure. Unfortunately, she went to an outside facility, had a brain MRI that said potentially this or that. I saw her in the office and she was doing fantastic. Her symptoms resolved, was treated for glaucoma. We still listed it as a CBA, that was the only one. And then no mortality, myocardial infarction, pre-cardiac synthesis, or device amputation. 45 days outcome, like we said, 97% of patients were able to be successfully cessation, anticoagulation at 45 days. One out of those 70 cases had device-related thrombus. This patient had HOCUM, and so he was off-label. We had this bad discussion ahead of time. He was discharged on the big trend and he had also some questionable compliance issues. I put him on Coumadin and the clot resolved. One patient had a possible pre-device leak, more than five millimeters, and that was difficult to assess on the follow-up CT scan, so we just decided to continue anticoagulation for now. This is my procedure characteristics. I had about more than one patient, more than one Watchman device size was attempted in about 15% of the cases. For the total procedure time, it was 47 minutes plus minus 11 minutes. My time to perform my triceptal was about 20 minutes, and time to watch my device release was 45 minutes. And this slide shows it kind of in a visual way. So I'm going to present a case. This is a typical case that I've dealt with, a permanent AFib patient, 74 years old, significant GI bleed, one aliquis, type 2 diabetes, and he tolerated 2.5 BID aliquis for a few weeks, but not the five milligrams. So this is my summary of everything that I do in a eyes guided left atrial appendage closure, pre-triceptal puncture safety assessment, and then triceptal puncture under eyes, and then you assess the left atrial appendage using eyes for device sizing, and then you post deployment assessment. And we're going to go through them one by one here. So first I start with baseline effusion check. I put my catheter mostly in the right ventricle, and then I visualize the left ventricle and I roll out the effusion. And then this is my triceptal puncture. I tried to visualize the left atrial appendage so I know my sheath is going to be aiming toward it, and I do a pulse wave in that appendage and confirm that this is the appendage. And then this comes in the triceptal crossing with eyes, and with the Equinav, I do bilateral groin access, so I'm having the Equinav through the left groin and my watchman's seat through the right groin. And this is the trick that I developed and it really helps me in crossing my eyes into the left atrium. I have my rep come in and put a dot at the top of the dilator right after I do my triceptal puncture and before I dilate. And so my dilator is sitting right at the septum right now, and I just did my triceptal puncture. I have my rep come into the screen and put that little dot right on the top of the dilator, so I mark where the septum is. And then I go with my eyes, mostly fluoroscopy, and I'm looking at the eyes image as well, trying to ride that wall, that wire, and then just cross into the septum, through the septum into the left atrium. And then, obviously, I go ahead with the watchman technique. I do your images. I do my pre-watchman images. I size using 4D catheter. So you just park the catheter in one spot and the rep will take a picture, and then you just go ahead with your procedure. You just go ahead and get your sheath up and you start doing your watchman while they're doing their pre-device measurement. Then I get my watchman in, deploy it, take a picture, confirm with a tug, and then you go back and look on ice and take another 4D image. And now the reps are looking into it and they're giving me my compression, making sure it all aligns. And then that's another image here. And then I go for, you can use also 4D NPR to assess your compression if you couldn't get a good picture. And then I go for 2D color assessment. So I park the device where it was, and then I go right, left, sweeping through the device to image in multiple planes and make sure there's no significant leak. You can also use 4D, you can use NPR, and you can use 4D color assessment that's coming up with the Lomas device to rule out any significant leaks around the device. And then I like, for best practice, I like to take my catheter and put it in the mid-atrium and get a mid-atrial view of the watchman. And my rationale is this is what the TE image is going to look like. So I like to get it into the mid-atrium, take a look at the device, make sure it all looks good, and then release. After I release, I rule out any pericardial fusion and we're all done. So this is a workflow for this particular case. The patient was in the room around 9.20 in the morning. The local anesthesia at 9.39, eyes inserted at 9.46. 10 minutes later, I've done my triceptal, I've done my left atrial appendage angiography. Five minutes later, my watchman in place. Took me about 5-10 minutes to confirm the PASC criteria, and then eye catheter was removed at 10.13. I was out of the room at 10.15 a.m., and patient out of the room 10 minutes later. I used Z-stitch on both sides so I don't do periclose, and then patient out of the facility at 4 p.m. So left atrial appendage closure with watchman. Flex device is safe, feasible, with excellent outcomes. This approach may facilitate wider adoption of eyes guided left atrial appendage closure, which is better, less invasive alternative to TE guided left atrial appendage closure. Thank you so much. I think we're going to start some question and answers. Do we have some time for that? Okay. I just want to kick off the first question, Adnan. First of all, great presentation. As an interventional cardiologist who doesn't do a lot of triceptal punctures, I imagine, you know, you have an audience of EPs that have been doing this for a long time. How long would you say is the learning curve of getting the eyes catheter in the left atrium? Right. Great question. And obviously, I did structural heart fellowship, and I had a great EP mentor who I did most of my watchman training with him. So and he taught me how to do eyes across the septum, across the septum with eyes catheter, and then just go across the septum with the, it was to the eyes catheter. So I would say throughout my fellowship, you know, it took a, it took the entire fellowship to be really comfortable doing all this. Once I got into practice, and I wasn't sure what my skill set is going to look like without any mentor, and I tried with one procedure, and it went really well. I was, I don't know if I was lucky or what, the eyes catheter just crossing the septum, and it was great. So then I got encouraged, and then I scheduled three procedures about a couple months later. I screened them pretty well. I knew that everything's going to align, it's going to look good, and I was able to get through them as well. Now, how long did that take me to get to this timing? Probably I would say 15, 20 procedures that I did outside of training until I really got my technique sorted out. And I think the challenge is that the entire industry has been learning, you know, with doing this, and so there isn't necessarily formal training, right, that you'd go for a conference or something to learn it. Now there is, so there's an advantage of getting more expert in a shorter amount of time now that there's formalized training, but I agree. I think it probably took around the same time to do that. I'd like to open it up to any questions in the audience, and we have a microphone we can pass around. Any questions? You were saying put the ice on the left side. Have you seen more interactions between the sheath and the ice catheter when you use the same side? I did not try to do it on the right, on both sides. I just think they're both pretty big, or 14 French for the ice, and maybe 17 French if you're using the true steel for Watchman, so I just felt to be too much to do it on one groin, and so I I've heard of people doing it. I have not personally tried it. I just always use two groins. Would you, would you consider putting both in a single stick or double stick the same vein? I've been, I was using the Philips. It's a little smaller, but I was doing the same side for both of them. Yeah, I mean, I think a micro is, you know, 20 plus, right, and we have no issues of putting a micro in a vein, so I think, I guess, it's all what you're comfortable in. Another follow-up question. Have you needed TEE to bail you out when you're not confident of the post images, if you have a leak or a big shoulder? That's been our learning barrier, is to try to figure out how do we need TEE backup? Are we going to be able to scramble and get an imager in there? Or does that really not happen? I did not need any TEE backup. I mean, I was able to visualize it, especially with the Equinav. I was able to visualize the Watchman pretty good, and if I don't like it, I just do another size or take the device out, and I, like I said, there were two patients I couldn't do it. One of them, I just didn't like how the Watchman sat, and there was a large shoulder, and I decided not to do it. I'll take that. I'll tell you, I started with everything, all redundant technologies to begin with, and then I slowly started to dismiss some of them as I got more comfortable, and what we found, and I do this, in the era that I used to use TEE and ICE, we would take measurements to compare what was accurate or whether we saw shoulders the same, and it was the same, and so now we don't need, and it was the same, and so now we don't need, there's a machine in the room, but we don't call a cardiologist to, you know, be there as a backup or anything like that. I mean, if you can get the ICE catheter in the left atrium, the visualization now with the technologies that are available, it's, in my opinion, it's sufficient. I second that, and especially if you put in the mid-atrium and you look at the appendage from the mid-atrial view, it's exactly what you see on TEE. Yeah. So, I don't think you need to do it, and with the 4D images, you can just go through it, and you don't need anything. But you have, everyone will get to that comfort level independently, and so it's good to have the redundancy so that you can prove to yourself that it is. Thank you. Any other questions? As we, as we keep making larger and larger holes in the septum, do we have, I know what you're asking. Do we have data yet about at what point it's too big of a hole that the closure rates aren't, you know, 100% or near 100% over time? Yeah, so I'm very curious to hear what the audience has to say about this, but I've seen, so, you know, everybody does backup, follow-up imaging after device implants, so you're able to get sort of a second sense. I, first of all, I have never had, I've had one patient that had six ablations, and it has nothing to do with putting the ice in, if they just had six ablations, and had a huge atrial septal defect and developed pulmonary hypertension that needed to be closed, but that was independent of this. The reason I mention that is, can it theoretically be possible that you create a continuity that then becomes hemodynamically significant? Of course. Since I've been putting 40 ice, though, knock on wood, most of them have closed, and if there's a residual defect, it's clinically insignificant. Now, I'm sure somebody's going to bear that out with data, because we're collecting that ongoing, so it's probably easy to prove with evidence. My gut is that it probably doesn't make a difference. And I'm just going to add that, you know, with MitraClip, we do this in 24 French and across the septum, and we have not seen any major problems. Okay, I'd like to thank everybody for taking time out this morning to share all the new technologies and new ways of doing our procedures. I think it's a very exciting time. I'd like to thank Adnan for for being a co-presenter and Siemens for for putting this this hall up. Thank you.
Video Summary
The Rhythm Theater session, led by Dr. Devi Nair, a cardiac electrophysiologist, explored the use of 4D ice imaging in PFA and LA closure procedures. The discussion covered the benefits of concomitant procedures, particularly in AF management, by potentially reducing procedural times, anesthesia needs, and patient recovery. Dr. Nair highlighted the technological advancements in imaging catheters, notably the Lumos catheter, which features a wide field of view and Doppler capabilities. The session emphasized the importance of procedural efficiency and patient care enhancements.<br /><br />Dr. Kevin McCarty presented on leveraging 4D ice to enhance contact assessment during PFA without needing mapping systems, promoting a streamlined, low-fluoroscopy workflow. He argued for using 4D ice as a real-time, efficient imaging tool to ensure effective tissue contact and ablation precision.<br /><br />Dr. Adnan Kassir addressed the feasibility of 4D ice in left atrial appendage closure, showcasing its success and safety compared to traditional TE-guided methods. He shared his workflow for efficient procedures and discussed learning curves in adopting new imaging techniques. The session concluded with a panel discussion on procedural challenges and advancements.
Keywords
4D ice imaging
PFA
LA closure
AF management
Lumos catheter
procedural efficiency
low-fluoroscopy
left atrial appendage closure
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