All right, welcome to everyone for attending this next theater session. Today we're going to talk about concomitant procedure, the procedure that is changing probably most of the people who are here in this session today. I know we're definitely seeing it in Salt Lake City. Patients are coming asking for it. Referring physicians are asking for it. So we've got the rock stars of EP here with us today to help us to better understand how to optimize this care for our patients. Just a quick housekeeping item. You'll see there are no microphones to ask questions. Instead, it is submitted. There's a QR code, and we will have that up, and feel free to submit, and then there will be a Q&A after. So as far as who we have today, our rock star panel, we've got Dr. Amin Al-Ahmad from Texas Cardiac Arrhythmia, Devi Nair from St. Bernard's Heart and Vascular in Arkansas, Waleed Saliba from the Cleveland Clinic, and my name is John Day, and I'm from St. Mark's Hospital in Salt Lake City, Utah. And so with that, let's go ahead and kick it off. So the question, why concomitant? Why are we even having this session? So first of all, pulse field ablation, as we all know, carries that promise of a faster, safer, more effective procedure. Watchman in particular has really proven itself with countless studies over the last couple of decades. And then now with the recent approval, it happened in October of last year, it's now something that in the United States can be done at the same time as part of the concomitant procedure. And that name concomitant is quickly moving through the field, and like I said, even our patients and referring physicians now know what they mean by the concomitant procedure. And with the goal of helping to prevent repeat interventions. It really makes no sense. Why do we have to get vascular access twice for the patient who needs both an ablation and a watchman? Why do we have to do a transeptal twice? Why are there two recoveries? From a patient standpoint, they want it all together. And so what do the data say? And so we'll kick that off with Waleed. Go to the next slide. Okay. Well, thank you, first of all, for being here. I'm going to talk to you about some of the data that we have about the option study sub-analysis of the individual groups. We are all familiar with the option study that was published back in fall of past year. Essentially, 1,600 patients randomized to either a device with a watchman flex or oral anticoagulation. This is in the setting of post-atrial fibrillation ablation, by the way. And the idea is that of those 1,600 patients, there were two groups. One group are the patients who already had an AFib ablation three to six months before randomization, and then were randomized to either having a watchman flex or oral anticoagulation, what we call the sequential group. We are not going to talk about these. We're going to talk about the patients who have not had yet an ablation, were randomized to either ablations concomitantly with watchman flex placement versus ablation alone with oral anticoagulation. So device versus oral anticoagulation. The concomitant group constitutes around 40% of the overall option patient population, and these patients are going to be the subject of our discussion here. Now, we are not comparing concomitant versus sequential because these are two different patient populations in the study. They were not randomized based on the time of ablation. They were stratified as per ablation time. So two different patient populations. As you know, the concomitant group, more of these patients were done outside the U.S. They were slightly older than the sequential group. They had more atrial fibrillation because they did not have yet the ablation done, and they have higher incidence of renal dysfunction. So a totally different patient population. We're going to talk only about the concomitant group. And as you know from the primary results of the option study, the study met its efficacy endpoint, primary efficacy endpoint, which is a non-inferiority as far as a composite endpoint of death, stroke, and thromboembolism, thromboembolic complications, as well as it met the primary safety endpoint, which is a superiority endpoint for non-procedural major bleeding and non-major clinically relevant bleeding. And these are the Kaplan-Meier curve for the primary efficacy endpoint and the primary safety endpoint, but now this is in the concomitant subgroup. In the concomitant subgroup, those primary endpoints, efficacy and safety endpoints, are also true for the concomitant group, whereby there was a non-inferiority for the Watchman Flex compared to the oral anticoagulation arm following atrial fibrillation ablation, as well as the primary safety endpoint, which was in favor of the Watchman Flex compared to the oral anticoagulation in terms of the reduction in the incidence of bleeding. Now, you wonder whenever you add left atrial appendage closure procedure on top of an ablation, are you paying the price in terms of increased adverse events of the procedure, as well as is there a change in the outcome of the atrial fibrillation ablation? In this situation, there was no change or no increase in the adverse event outcome by adding a left atrial appendage closure to the atrial fibrillation ablation. You can see there, 2.7% versus 2.1%, and most of these essentially were comparable in the two groups. More importantly, here, before I go there, more importantly, when you look at the outcome of an atrial fibrillation ablation, you can see that, or you cannot see because the slide is not there actually, I can tell you that there was no difference in terms of the rate of cardioversions, as well as the rate of repeat ablations in the two arms of the study, meaning that the addition of left atrial appendage closure to the atrial fibrillation ablation did not change the efficacy and the outcome of the atrial fibrillation ablation. Now, whenever we put a device such as the Watchman Flex, and I know we said non-inferiority of the composite endpoint, but what we're truly interested in is, did it actually change the risk of ischemic stroke because that's what the Watchman device is made for, is to potentially reduce the ischemic stroke rate. And as you can see here, when it comes to the ischemic stroke, the numbers are small, 1.6 versus 1.6, unchanged in the device versus anticoagulation. And when you look at the primary safety endpoint, whereby there was superiority of the device versus anticoagulation, that superiority was mainly driven by the non-major clinically relevant bleeding episodes. When it comes to seal and DRT, this is, again, in the concomitant arms, you can see that the overall seal is around 97%. We're talking about either complete seal or less than 3 mm. 97% complete seal or small leak at one year, and only one patient with peridevice leak experienced a stroke, and that patient was in the higher peridevice leak category. When you look at the device-related thrombus, you say, oh, at one year it's 3.5%. If you compare this to the pinnacle, which is less than that, when you look carefully at the type of device-related thrombus, you see that 8 out of 10, so mostly these were laminar thrombus and not pedunculated or globular thrombus on top of the device. But more importantly, no patient experienced any adverse event related to device-related thrombus. So that is probably something that we ought to think about, that what we're looking at is maybe delayed or part of the continuum of the maturation, if you want, of the device rather than actually device-related thrombus. So the limitations of this study was that, obviously, this is a post hoc analysis of the option trial, and it was not designed to compare concomitant versus sequential. We're only talking about the concomitant. And the ablation and the option clinical trials were primarily RF. In the era of PFA, I don't think that this is going to change much, the results of this trial. So in conclusion, left atrial appendage closure reduced non-procedural bleeding compared to oral anticoagulation without increasing the risk of thromboembolic events or stroke. There was no difference in procedural safety with the addition of the WatchmanFlex procedure to the ablation. And there was no change in the ablation efficacy by the addition of the left atrial appendage closure to it. And the WatchmanFlex implant may be a reasonable alternative to oral anticoagulation in patients undergoing AF catheter ablation. Thank you. Excellent. All right. Well, thank you, and thanks for those who have been submitting questions. It's nice. We're gathering up these questions. We'll have a very lively interaction here a little bit further. So now it is time to poll you all. Make sure you're still with us and listening. So first case. Now, we're doing this old school audience response, so we'll go by the up raising your hand. What would you do? We've got a 75-year-old patient. They've had a prior pulmonary vein isolation procedure, and they're currently on an antiarrhythmic. Let's just say they're doing well on their antiarrhythmic, okay? So they're on flecainide, and they're doing well. They've also had a GI bleed. Their CHADS-VASc score is 5. So your choices are, as you can see here, A, PFA only, B, Watchman only, or C, concomitant. So let's see by a show of hands. How many A's? Okay. How many B's? A few. How many C's? All right, so C seems to be the most popular, but a fair number of B's. I don't think I saw any A's. So expert panels, what do you guys think? Are we surprised? No, I think that's what I would do personally. I think that this is a patient that really deserves a Watchman-type device. There's no question about it. The GI bleed, the elevated CHADS-VASc score, the risk of stroke. But, you know, at this stage, you're in there, and you know that they've had a prior ablation. They're on antiarrhythmics. It's very likely they're symptomatic from it. While I'm in there, I might as well just do an ablation and then put the Watchman. My partner calls it a drive-by ablation, but that's what I would do. Even though they're doing well on their flaconite? Yeah. Even though they have not had recurrence? Yeah. On flaconite. On flaconite. I mean, 75. I mean, you're not going to be on flaconite forever. I think it's worth it. I would do it. You're in there anyways. All right. Waleed, what's your take on our audience response? So that patient falls in the category that they have an indication for left atrial appendage closure. They have a very soft indication for an afib ablation. In the era of RF, I would probably think about twice to do a concomitant afib ablation. In the era of PF, obviously now we are taking patients with less atrial fibrillation burden, sicker patients, older patients, heavier patients. So that falls into the category of softer indication. But if I'm in there in an attempt to get them off flaconite, I might have another look because they might find something that you get rid of it and then you get them off the medication. Devi? I think if the patient wants to get off the antiarrhythmic, I absolutely will. But I agree with Waleed. I think in the era of PF, my cadence to the patient's discussion is going to favor let's get both done. All right. Let's do another case, shall we? Do they agree? Did we change your mind? Did anybody change their mind? Raise your hand. Is there a sign of weakness? No, I think they kind of had it made up to begin with. Let's give them another case. Okay. Next one. 78-year-old now, female with coronary artery disease, PCI, hypertension, diabetes, heart failure, recurrent persistent atrial fibrillation on amiodarone. Poor compliance with oral anticoagulation due to cost, which at least here in the U.S. that's not surprising since Eliquis and Xarelto are more than a car payment. What do you want to do? How many want to do PFA only? Can we see by a show of hands? How many want to do Watchman only? Show of hands. Okay. One brave person. How many concomitants? All right. I didn't see a lot of hands go up. How many don't know? All right. Expert panel. We'll start with you, Debbie. Were you surprised by the results? I would say I thought I would see more concomitant hands go up because to me poor compliance, I mean, there are many reasons why patients don't take anticoagulation. And I think our job is not to judge but to take care of the patient. And cost is something you have to live with. I mean, if they cannot afford it, and that's a very high-risk patient to me, getting them back in sinus rhythm as well as giving them stroke protection is the right thing to do and do it together one time. Waleed. So concomitant is a good choice because it is a concomitant session. Right. If you just answer concomitant to everything, you're probably going to be right. But that, I mean, this patient falls in the category of an indication for a-fib ablation, a strong indication for a-fib ablation. And I would like to put it as much as I respect the fact that she's poorly compliant because of cost, softer indication for oral anticoagulation because we can give them cards for that. It is a Medicare patient. Exactly. That too. But if I'm going in to do an a-fib ablation, I might as well put a left atrial appendage closure because my reliance on this patient to really take care of herself in terms of taking oral anticoagulation down the road and maybe a-fib might come back. So I would rather do both at the same time since we're in there. Amin, you get the final word. The final word, yeah. So these are tough patients because of the poor compliance due to cost. It's a very real thing. I mean, we see some patients who will take only one to save on the medicine. We'll see some patients kind of break it in half to save money. And we do give out cards and we give out samples, and this is a real issue. And so I agree with Debbie. I think this is somebody who I won't, you know, we're not going to judge. We say this is a reasonable candidate for an appendage closure device. And then as far as the a-fib goes, you know, I'm not a huge fan of amiodarone. The patient has heart failure. There's a lot of reasons to consider this one for an ablation. That said, I do want to get a sense of how symptomatic they are and all that other stuff. But I think if you're in there, it's very reasonable consideration to do both. And this is kind of a very typical patient in what we might see in our practice. Okay, last case. 72-year-old, recurrent proxismal atrial fibrillation, and they're symptomatic on MOLTAC. CHADS-VASC of four, GI bleed due to AV malformations. How many want to do PFA only? Watchman only? Concomitant? All right, I'm seeing about every hand go up. What do you guys think? Mic drop. Everybody wasn't ready. This patient falls in the category of indication for ablation and indication for watchman for left atrial appendage closure. All right, so you agree with the audience? Yes. All right, strong work. Anybody have any other comments? Okay. All right, I'm going to pass the clicker next to Devi. So I think we kind of make a sense now that we're going to talk about concomitants. What we want to do on this next maybe, I guess, 15, 20 minutes is kind of go through the workflow. How are we thinking about concomitant procedures? I mean, we are getting very good at doing ablations. We're getting very good at doing appendage closure. We have a safe therapy. But trying to bring them together, how do we make it not only just an efficient workflow but also a safe and efficacious workflow? And that's what we are going to try to pull through today. And, of course, all four of us practice in different places, but there are certain things I think we all do the same way, but there are certain things that we do very different, and hopefully we can have a good discussion on that. So let's start with very procedural planning. So I am a very strong believer in planning ahead. I don't like surprises in the lab. I truly believe that success favors a prepared mind, and that's who I am. Now, having said that, it's not very feasible all the time to get a pre-imaging and CAT scans and whatnot, but especially in the concomitant population, I definitely feel like pre-procedure planning is one of the things that we like to see. Now, one of the other things is Venus axis. Obviously you need two axis points. We can talk about the intricacies of that. John, do you want to maybe talk a little bit about the pre-procedural planning with our panel before I move on? Sure. Let's let our other two panel members weigh in. Concomitant pre-procedure planning. First of all, what comes first? Ablation first or Watchman first? And then what pre-imaging should be performed? ICE, TEE, CT? I practice in the unprepared mind group. That's good. It's always nice to have a little diversity. So we don't do the CT scan ahead of time, but we will typically actually have a TEE probe down, take a look before we do. And we do ablation first and then have the TEE probe pulled back a little bit, finish the ablation, which takes very little time, and then place the Watchman. Some days I regret being in the unprepared mind and would rather have a CT scan ahead of time, but most of the time we can get away with not having a CT. And I think the Watchman is a very easy... Generally speaking, it's very hard to find anatomy where it won't work. So that works well for us. What do you do in Cleveland? Similarly, we don't necessarily do CT on patients pre-procedure, but we do TEE because we want to get measurement of the left atrial appendage before we start ablating baseline. So similar to you we do TEE then obviously ablation first and then followed by device placement after. All right Devi back to you. So I think we are since both of them do TEEs I decided I'm gonna show an ice case so there you go. All right so so as I said I do pre-procedure planning and I'd like to know if I can I would say about 60 to 65 percent of our patients will get it pre-imaging. Helps you you know pick the size you kind of know where you want to do that transeptal. I think those things are important when it comes to a concomitant procedure and in this patient the average that we're seeing is about 21 millimeters and this is a AI software that kind of gives you a virtual implant and this is a 27 millimeter device and a 31 millimeter device that's been projected out there and so I kind of get an idea of what this should look like. The yellow means it's touching red means it's not touching so my goal is I have great through tools today I have a steerable sheet I have a great device I should be able to mimic this AI I should be at least as good as this AI is what I hope. I think you're better than the AI. We'll see. All right so the next thing is how do you plan that transeptal right I mean both procedures and the reason we even talk about concomitant is because we're in the same room and so we need to make sure that we enter through the same door if at all possible and at least that's how I think about it and I think I personally I look at the appendage I look and see where my transeptal needs to be to be coaxial to the appendage closure. I feel like it's the PFA part the ablation part is a little more forgiving and I can get away with wherever I do my transeptal. Any other thoughts on the panel about where the transeptal is usually? I agree with you I think your trend I generally put my transeptal where I think the Watchman is the best trajectory rather than the ablation because the ablation she's very forgiving. So let's let's see about considerations when you're just doing PFA when you're looking at Farapulse I think usually we're looking at like a mid anterior or a mid mid transeptal. The mid is usually the mid is usually not a great position for a for an LA closure device you're usually looking at an inferior stick. Rarely we do do mid sticks when you have a posterior windsock or anything of that sort but I would say 90% of our LA closure sticks are inferior. Now whether it's mid or inferior anterior is a different story that really depends on which direction the appendage goes but so for me I think I my sticks are mainly usually inferior mid or inferior anterior for these concomitant procedures. So let's look at the system so what I'm going to show in my in the in the case that we go through is the Faradrive sheet but I'm using an integrated transeptal solution that the Faraconnect or Versaconnect system that is a dilator that it's a true form dilator so you can shape it and you can get to the precise location that you need. The transeptal is through the integrated RF wire so you deliver and it has a pigtail loop that takes you across so I like the no exchange aspect of it and that is what we'll be using. So this is the of course if you have a CT you can also look at the pulmonary vein anatomy and see what you are looking at from an ablation standpoint. You can see the pulmonary veins are quite far apart and because this is a paroxysmal patient that we were dealing with we decided to do a PBI only. So here we're getting access with ultrasound. I get two access points. I'm short and I'm not short. I'm vertically challenged so I stay on the right side and I stick on the right side and I get two access points on the right. Usually I tend to do vascular closure so my patients usually go home the same day and early ambulation is one of those things so we're getting access. We're coming in with the Faradrive sheet so you'll see me take the sheet. We kind of make that curve that we need. Make sure that it's it's in plane there so here we're getting that's a Farra Connect or Versa Connect. I call it Farra Connect. I think it's called Versa Connect but anyway so we're going up the loop. I don't use fluoroscopy for my ablation part so I tend to look at the do the entire procedure with eyes guidance and mapping guidance. So here you can see the sheet going into the superior vena cava. We're coming down for our transeptal that is the RF wire going across and again you can in this case we are using a 40 ice catheter so you'll see me kind of get that plane. We'll get the ice catheter into the left atrium through that same transeptal so we dilate that transeptal. We take the ice into the left atrium and then put the sheet across. So before I go into the next section just curious are you guys using the same transeptal site? Are you doing two transeptals same side of the groin? Single transeptal. One transeptal access. I think that is kind of the way we are we are doing it now. Now even though we did I will get pre-imaging and you can see this is ice in the left atrium. We get quick imaging to see what it looks like. Of course here we're using a 40 ice. You could potentially do 2d ice. For my leg closures I prefer 3 40 ice just so I can assess the device better. So we'll get quick measurements make sure you know there's no thrombus. Before I get the ablation system across we'll clear the appendage this way. John you want to take over a little bit on the Farah pulse system and the Farah drive? In fact I'm going to take give this one back to the panel. So the Farah wave catheter with integrated mapping is definitely a new development. It has a lot of potential benefits as the imaging is getting much better. May potentially also allow for not using a dedicated mapping catheter. So what has been your experience with the Farah wave catheter? Thumbs up? Thumbs down? Oh a double thumbs up. All right Debbie that deserves. You got to explain why you gave it a double thumbs up. I get to show it. All right then keep us going. All right we're going to do it that way. All right so what I want to just focus on is what I'm going to show is the Farah view workflow or with the opal system. So this is the Farah wave catheter within the arrhythmia system or the opal system. And what you're going to see is the catheter in it you know you can see the catheter in its flower configuration in its basket. It's a dynamic visualization so in its non compressed state as it comes into flower. And what I like about it also is that you get the tags. You get these field tags that are based on the biophysics of where that lesion would be would be projected based on the biophysical parameters. And so for me knowing where I applied, knowing that I've done enough applications in an integrated solution is important and visualization of the system is important. So as I said we are not using fluoroscopy. We have the wire in the left superior pulmonary vein. My practice is to do usually four baskets and then four flowers. If I need to do additional flower lesions we'll do additional flower. But what you see on the mapping system there is the Farah wave system in a basket configuration. You can see the field tag that shows what the field tag looks like. Obviously this is edited down in the interest of time. And then we will rotate the system to make sure we have adequate overlap. So you can see the catheter. You can see the system. Amin you wanted to jump in? I did. I mean I think that rotation aspect is underappreciated as being important because with other software you really don't appreciate the overlap when you rotate. Whereas with this you can actually see that you're getting good coverage. Because sometimes it's easy to over rotate or under rotate and you're not entirely sure did you get the kind of overlap that you need. So this is this is kind of one of the reasons I like this. I agree and I think that the fact that you are not with the other mapping systems when you when you do it you are calling out that you're in a basket or you're in a flower configuration. Whereas you can see this dynamically move from an uncompressed state to the basket to the no to the olive to the basket to the flower. I'm from Arkansas. We have biscuits too. So here you go. So now we're in the flower configuration and you can see here's where I think you really appreciate that rotation and the overlap of the rotation. I like to you know sometimes do anchor lesions to get that anterior ridge well. And I'll do sometimes a little bit of posterior anchoring as well to make sure that I have adequate overlap. And here we have the lesion tags at five. Now the when it comes out of I guess the nominal is seven. I'm a little more conservative. I take it down to five. And the darker the red shade you have done more than two applications. So that's good. So when it's a I say that's a that's a great color for a dress is what I say. But anyway when I get to that color we're good. So here we're coming into the left inferior pulmonary vein. We're getting in that basket configuration. We're delivering the therapy. We're rotating it. And you can see I over rotate it. I adjust it back to where I need to. But I also have my eyes in the left atrium. I'm looking at contact. I'm looking at ice to assess contact. The system doesn't tell you contact as well. There's no contact sensor. So you really have to use ice to make sure that you have adequate contact. Because contact does matter. And here you can see we're getting the the lesions along the left inferior pulmonary vein. Valida I'll let you jump in and see if you have any other suggestions on the workflow. Do I need to do anything different Monday when I get to the lab? No. So you just if you're using this software with the faraway catheter there are two ways to do it. You either you see Debbie here is ablating and acquiring geometry of the left atrium as she ablates. Maybe at the beginning of your experience you want to try to get a geometry of the left atrium so that you know where things are and then start ablating. And it doesn't take really too much time to acquire that geometry. You can get it in in less than a couple of minutes actually. And that's what I do initially with the fellows especially to know that where the geometry is and then you can proceed with ablation afterwards. So you can have a better idea where things are and how do you want to overlap your lesions. That is a great point and you can see I did not acquire geometry. I'm in the right superior pulmonary vein. I'm also seeing it on ice in 3D. I liked if I have a 3D catheter or I like to look the right side in 3D 40 just to see how big the carina is or how far the carina is. But again that is a good point. The reason I don't do a pre-map is because I have ice in the left atrium. I kind of can see everything very clearly. Here you can see I've moved on to the right superior vein. You can also appreciate those field tags. I can assess how far the left superior vein is from the right superior vein. Am I leaving a critical isthmus behind? So I can plan whether I can leave this as a PBI only lesion set or am I gonna have to do a little bit of touch-up in the roof and connect it and to prevent any kind of critical isthmus. Now I mean do you do a full map before or do you go map and ablate? I've done it both ways but I kind of like doing a quick map. I kind of just like to wave the catheter around get an idea of the geometry and then I and then I go in and start. It doesn't really delay me too much. I think it generally is a pretty quick procedure. It's yeah again that you can do it either way as long as you know that you're not missing a pulmonary vein and that's the key. We already knew what the anatomy was from the CT so you got to kind of think about all of this so if you don't have anatomy you don't know what you're dealing with probably a great idea to maybe get a pre-map know where where your lesions are landing and then go from there. Now so Debbie I was just going to say since you had done the CT one of the questions that had come in here just a minute ago is do you ever integrate the CT into your map since you just start with the pulmonary veins? So it's a great question. I do not know if I can integrate into Opal because I've never tried it but I'll ask I'll ask somebody if it can. Anybody from from the company that can tell me if it can be integrated? The answer is a yes. There you go yes it is so maybe I should try that I don't know we'll see but that's a good point you could you potentially could I have never tried it see you always learn something awesome. So we're learning too about biscuits. Biscuits are useful in the common pulmonary vein. I'll leave it that way but you have to be careful the lesion sets are not defined. So here we are in the left right superior pulmonary vein. I think one of the things I appreciate putting ice in the left atrium is you can you can you can clearly see the areas that are much thicker like the roof of the right superior pulmonary the posterior roof of the right superior pulmonary vein the carina area the anterior septum there are certain areas that are much thicker and I tend to do a little more applications in those areas than just the two applications sometimes just to make sure that I have I have more durability. All right so here I do do some mapping so here's a map for you so there's the post map just to make sure that we didn't that the voltage looks okay and we'll make sure that our lesion sets and everything are good and we did adequate overlap this is again at the five tag so that's a pretty good dense lesion set in my mind and that was just for funsies. All right so let's talk a little bit about the Watchman Flex Pro device. The Watchman Flex Pro device is the device that we use today at least in our lab so it is built on the Watchman Flex platform with a lot of new advantages it still has that 18 strut frame but it comes with these radio peak markers that help you implant the device in the most optimal position so you can see it on fluoro where those markers are there at the they need to land around the ostium of the or the orifice of the the appendage. It has a non-thrombogenic coating that allows for a better healing and improves hemocompatibility so potentially will decrease a device-related thrombus. It still has that dual row precision anchors that makes the device stable. It is still has that closed soft end so allows for very safe implantation allows for full recapture repositioning and redeployment and also comes in a 40 millimeter size so all of these combined it comes in with the the Pro platform. I want to just kind of jump in and talk a little bit about the steerable sheet as well. I told you I'm a big fan of steerable sheets. I believe that every case should be done with the steerable sheet and I probably will get kicked out of the stage because of that but that's okay. I believe that the steerable sheet gives you the most optimal implant. Before the steerable sheets I still felt like I was able to implant most devices well but to me what the steerable sheet gives me is this capability of optimizing it even further. Now I'm gonna give this microphone back to Amin and Valid and John and see what they think about it but I'm holding my ground. No I you know the problem we have is we're in a small community hospital in Austin. You all know that small community hospital. They don't buy us these steerable sheets. You want another PFA generator? Sure we'll give you four of those but to get a steerable sheath? No we can't get that. I agree with you I would love to have the steerable sheath. In fact there's there's cases where you're sort of doing it and you're like oh my god if I just had this instead of having to restake or do something like that. So I you're probably right but I just have no experience with it. I've done maybe an N of one when they when they sort of let us have it so you need to talk to our administrators which you need to do. We're in the same system and we have access to this in Salt Lake City so I don't know what the challenge is there at that small community hospital in Austin. How about the big Cleveland Clinic? So at the Cleveland Clinic we have a lot of money but they wouldn't pay for the steerable sheath. But I understand we are we're gonna start using it so I'm an N of one too. There's also the learning curve to it I think if you use it for every case you kind of get to know how to use it. There are many advantages to the steerable sheath especially some of the unique you know chicken wing anatomies it works really well but also then you know you're just used to it and there's only one thing on the shelf in my mind. But coming back to just the workflow so we have already established the transeptal. Now I guess you know we I want to just talk a minute about the fact that you could have edema from PFA. We know that RF causes edema and you know we presented a data at the AF symposium showing that we can have edema with PFA as well. Do you go do you go back and image? Now I'll show you what we did but do you go back and image with your TEE, look at the measurements? Do you resize based on the measurements you got first or do you size based on the measurements you got after? And then we can talk about device placement. So I can take that. So I definitely we go back and image again for two reasons. Not only to see if there is edema and how much edema there is and whether it changed the opening measurement of the left atrial appendage but more importantly where is the edema? If the edema is gonna be around the landing zone of the device I might have some problems especially if the ridges is short and I can tell you that rarely but on a couple of occasions we had to abort a concomitant procedure because of that because the device tends to tilt if you put it and you have a short ridge. Most of the time the edema is very proximal and the landing zone is further distal and you don't have to worry about it and and I'm sure that we're gonna talk about it and we do tend to over compress if there is edema to oversize the device to have larger compression. John I mean do you have any thoughts on the olive configuration and I know there's some the data that's being shown that the olive configuration shows seems to have more edema along the the appendage. Do you tend to see that or no? You know that's actually an interesting thing because there's also a lot of data showing that the olive configuration may also if your goal is freedom from AF that may be an important aspect as well and so what do you favor? You mentioned at the beginning as far as transeptal all of our panelists favored biasing toward the Watchman rather than the ablation. What about with the olive? Do you buy bias toward ablation efficacy or potential Watchman efficacy or can you compensate? Yeah we tend to want to get one procedure done and done well so we will use that configuration and we do look at the you know pre and post for the most part I don't I don't see a huge amount of difference. Our practice in general is to use the length of the appendage as much as we can even if we're a little bit on the over compressed side because we believe that if you if you're on the if you don't use that length there can be some shifting of the device that we worry about and so I don't think we've we've had too many problems but would be interesting to go back and see with concomitants is there going to be an issue I don't perceive there will be but I think we need to know that a little better. All right so here I think we are getting the sheet so I take that Worsa cross wire that was with the ferro connect Worsa connect back put it in the pulmonary vein and we are getting the true steer sheet in of course I have fluoroscopy for this now as much as I love doing everything without fluoroscopy this is one procedure that I believe that needs fluoroscopy to add to look for compression to look at seal so I truly believe that this should be done with fluoroscopy so here we have the sheet across, usually it's pretty easy, the size is pretty comparable. Once it's across, I'll get a LA angiogram, and I don't tend to use a pigtail, I usually use the loop of the VersaCross wire to engage the appendage, and then, remember that loop is about 24 millimeters, and if I look at that loop, that's a little bit compressed loop, it's not in its full configuration, it's a chicken wing, but we already had all those assessments before, it looks like maybe, I would say 22 millimeters, 20 is what I'm thinking. Any pick on the size based on what we have seen? Yeah, I mean, we would tend to, I mean, your depth is kind of hard to say, maybe a 27 or if you can get a 31 in, but I agree with that about the loop, I mean, I love that, because one, it's got enough stiffness in body, so it's not just a wire, and the pigtail sometimes doesn't have enough stiffness in particular if you're trying to rail over it a lot, so this particular loop wire, the VersaCross wire, is outstanding for this, and it does help you size it a little bit, so yeah. What do you think, Waleed? What size do you want? I want to see the ice. I want to see how much edema, and where is the edema, otherwise I would be contradicting what I just said. There you go. Well, we're going to move forward. I'm going to probably pick wrong anyways, I don't know what I'm doing. I picked a 27, because the 31 on the pre-procedure planning was super over-compressed, so here we are deploying the 27 device, and what I'm doing is I'm deflecting the sheet down to make it a coaxial implant, so it's almost like you deploy it, and as you deflect that sheet down, it bends the device downward, allowing for those RO markers to land right at the orifice, and you can see the deployment again. We'll take the FlexBall out into the appendage, and we're deflecting that sheet down to make it coaxial, so sit more coaxially to the orifice of the appendage. We wouldn't know about that flexing. It's okay. Watch and learn is what I say. Kidding. All right, so here you have the implant on ice, again, kind of showing the implant and making sure that you are landing it. Again, remember, this is a 40EI, so we have that biplane advantage. I'm in that mid-atrial position. We will evaluate the system in all the angles. We're doing a tuck test here, and this is another time I actually liked RO markers. When they first showed me the pro device and showed me the RO markers, I was like, oh, whatever, and now I actually love it very much. I like seeing the RO markers move and go back to position. I like it to assess where I've implanted, so it is now my friend, I would say that. Here you can see the tug, and we'll look at color, make sure that we'll get that Nyquist down again, do all of the steps with ice. One thing I do want to ... Here's the angiogram, and you can see the shot. It looks pretty occlusive. The RO markers are in plane. John, do you like it? I like it. And I think one of the things that I would say is you can see the contrast kind of hanging out there a little bit. The velocities were pretty low to begin with on the appendage, but again, you can see on 3D ice, it's a nice position. We'll check for past criteria. Any thoughts on just ice versus TE? The way I look at it, it's one operator versus you have to bring the TE back in. Of course, I do TE-guided watchmans on a regular basis, and even with concomitants, I do. This case, it was just easy for us to do ice guided, so I think the key is to make sure that you're good at both procedures. Only do them if you have mastered both procedures, in my mind. Would you agree, John? I'd agree. What about our other panelists? I think there are workflow issues with this, and so I think you're exactly right. If you have somebody who can do the TE for you who's easily available, and that becomes an issue when you do concomitant, right? Because when do you call for the TE person? The TE person's not going to sit there the whole time, and so is it when you're doing the right inferior? You now call, or do you call before that? So these are the kind of issues that we're trying to work out when we have a TE workflow. With an ice workflow, you control the whole workflow, which is kind of nice. So I think it just depends on what your strengths are as an institution, but I agree with you. We're going to do ice. You really need to know how to do that well. All right, so here's the final angiogram after deployment, and you can see we have released, and you can see the ice catheter is in that transmitral view. So even if it's a 4D ice catheter, I'll take it into the mid-atrial position. I'll look for the view with the aortic valve. I'll look for the view with the mitral valve and the PA. So this is kind of that PA view with the biplane. We'll look on 3D. You really have to make sure that you don't leave leaks behind. Waleed, you want to talk a little bit about some of the data on leaks and concomitant procedures? Do you have concerns about more leaks when it comes to concomitant procedures? So if you look at the data in option, if you are talking about complete seal altogether, the data shows that it is slightly less than what we have seen in the pinnacle. Now, whether this is just random or related to the fact that it was concomitant, it's hard to tell because it is not related at the time that this procedure were done. There were no edema at the place where you put the device in place. So I think it was just kind of a random up and down. And if you take complete seal as well as less than three millimeter leak, then that is a 97% seal rate if you want at one year. So that's pretty good. I'd say that's pretty good. All right. The one thing I did learn from you is they're, we call them OS dots. I didn't know that they had another name. The little dots that are on the… It's Tishla. You need to… Okay. So I wanted to show you guys this data here because you think about the transeptal, which is kind of a critical part of what we do. And we don't give it a lot of thought, right? Because we've gotten so good and it's so routine doing a transeptal for us. But you have to think that this is really part of a whole system. It's not just doing a transeptal. It's part of a whole developed system of access, meaning it's the transeptal wire, this transeptal needle, the sheath, the dilator, all of that. And it's been engineered very well together to make something that's predictable and gives you, delivers results every single time. And when you do it really well, it's seamless and it's easy. And you saw Debbie's case, how she just did that transeptal and took a second or two. That's Debbie. That's Debbie, right. But there are other devices out there. There are other folks out there saying, well, I don't want to spend the money on this wire. I'm just going to electrify my own wire. I'm going to tap the bovie to a wire. I'm going to connect it to some other device that has not been tested, not been validated as well. And so this is an experiment that we did where we looked at that. And so we tried to emulate some of these newer devices that essentially are naked wires that have bovie kind of attached to them or electrified wires. You can see here in this, and I'll try and see if this arrow works, but the VC, which is kind of this light pink square, that's the versicross hole. And that's a real septum. And so you can see how punctate and clean that is. And you can compare that to the different holes that are created by the electrified guide wire, the EG, right. And so there's the 50 watt, the 30 watt, and the 40 watt EG. And you can see everything from inability to access to char and burn and things that you really don't want to see on an electrified wire. And you can also see in the bottom, and I won't go through the chart very much, but I will point out that when you use a validated, well studied technology, it's simple and you apply once and you cross, which is what our experience has been. However, when you use a sort of non-validated electrified kind of system, you may have to apply more than once. You're delivering more energy than you may necessarily think you're delivering. And as a result, you may end up with that type of char on the septum that you can see, again, in this type of experiment. And then lastly, the length of the guide wire that's electrified matters. And so, you know, with the Versacross system, it's really just the tip. Whereas with a naked guide wire that you apply electricity to, so this hybrid kind of system that people are trying to develop, you can get thrombus along that. And this is what we've seen in an animal experiment. And it's a little bit scary when you pull out this wire, you'll see sort of junk on it and thrombus on it. And that's what you're introducing into the heart. And so, I think that's kind of all I wanted to say about that because it's something we really take for granted. We just do it all the time. So, I think it's important to remember that there's devices that are well-validated and they have really good results. And you can use them to measure the appendage, which I like. So, thank you. All right. Managing edema during concomitant procedures. What do you guys think? We've been talking about it some. Waleed, you mentioned that sometimes you'll actually bail or abort the Watchman component. How often does that happen and what is your criteria? Very, very, very rarely. So, let me just give you a historical background. So, the reason why this was an issue is that with RF, as I said, we saw that there is edema, but usually it's localized. When we started doing PF, we did not know whether the edema is more diffused. Is it going to be localized? Is it less? Is it more? So, we did a series of animal experiments and the data was pretty much all over the place. In some animals, it was diffused edema where the appendage was almost totally closed. And in other animals, you can barely see any edema. So, with this in mind, we said that we have to take it to the human experiment. And at least so far, and I know Debbie is going to talk about her abstract that she presented in the AFib Symposium, but so far, we do see some reduction, a slight reduction in the loss level. But in the era of PFA, I don't think that we have had more. You've done probably the most among us with PFA and concomitant, but I don't think that we have had to abort or actually change significantly the size of the original device, size based on the original imaging that we got before the ablation. All right. I do have one point. We had several questions all on the same point. And as a disclosure, the device manufacturer recommends starting with the ablation and going to the watchman. However, given the issues of potential edema, given the issues of workflow that Amin brought up, we have several people say, wouldn't it make more sense to flip the order and do the watchman first? You can have more predictable access to TEE and then do, you know, basically flipping it around. What do you guys think? Yeah, I don't know. I mean, we sort of, my concern with doing that is once you place that watchman in, right, it may become a little bit more challenging to ablate in that particular area. In particular, if the splines kind of overlap a little bit on that ridge. In those dreaded 301 error messages? Correct, yeah. And so that's my concern is you may not be able to get as good an ablation procedure done. And I would say the issue of edema, although it exists, like Waleed and Mo said, doesn't really tend to change your outcome and what you do. And the workflow is an issue, but I think that that's something we have to figure out a little bit more. But my sense is still ablate first, then watchman after. I don't know if you guys have... I completely agree. I think there'll be a rare instance if I were to see a lot of smoke and sludge in the left atrial appendage and I know that there's no way I could tell the patient to go back on full anticoagulation because obviously they're there because of a massive GI bleed and it's not a full clot, then maybe I will consider it. But then I know it's going to be a challenging ablation, so it does come down to what do you do? I might actually do the appendage closure and stop and come back and do the ablation a few months later maybe. It might become a non-concomitant procedure. But even though we've seen... This was actually intracardiac eye measurements that were done before the ablation and after the ablation with olive, without olive, and kind of looked at the series of images and definitely we do agree. We did see that with olive configuration, we do see a little bit more sizing with a little more edema, a little more smaller appendages post. But the beauty of the Flex device, it's very conformable. And there's so much overlap. The worst thing is you might have thought that you are doing a 31 and you were on the borderline for 31 to begin with and maybe all you need is a 27 device at this point. The one thing I will warn is if it did look like a 31 but there is edema and you try to put a, say, a 31 device in there, you need to make sure that you do a good tug, that the device doesn't proximally move later on. And those are things I think you have to kind of keep in the workflow. There are two other concerns that are theoretical. So one concern is what Debbie mentioned is that the stability of the device when you give PFA energy in the vein in proximity. The second one that is really theoretical is I do not know what happens to the electric field when you have a piece of nitinol or metal sitting next to it in terms of efficacy of ablating the pulmonary vein. I want either some data to tell me that it is okay, that you are not having an inefficient ablation or an engineer that tells me that don't worry about it. All right. Now we are going to poll the audience here again. What is your expected growth in left atrial appendage closure in the next five years? Your choices are A, fewer procedures. B, same number of procedures. C, more procedures. D, significantly more procedures. And the last, I don't know. All right. How many A's? B's? C's? Okay. Fair number of C's. D's? How many E's? I don't see any E's. All right. Expert panel. What's your take on the audience's response? Yeah, I think reasonable. I think we're definitely going to see more, if not significantly more. At least that's my perspective. We'll see. I don't know. In our community, that's what, like I said, patients and referring physicians are asking for. Okay. Next. What is your expected growth in PFA in the next five years? Once again, the choices are the same. A, fewer procedures. B, same number. C, more. D, significantly more. I don't know. How many A's? B's? C's? A lot of C's. D's? We got some significant. E's? All right. No E's. Agree? Agree. Definitely. All right. Moving on. To how many of your Watchman procedures do you expect to add PFA? So these are people, maybe they're referred to you. For a Watchman device. Or historically, you would have only done a Watchman. What percentage do you think you'll now add PFA to? Your choices are A, none. You're going to keep the same criteria as you had in the past. B, it's a pretty rare thing. Less than 10%. C, 10 to 25. D, more than 50%. Or E, it's cut off from here. I don't know again. All right. How many A's? B's. One B. C. A lot of C's. D's. A few D's. E's. All right. Good. I think it's, I think there should be a C and a half. A C and an F. Why would you add a C and an F? What would your C be? What would your F be? Because 10, 25% I think is low. Because, I mean, over the past few months, I don't remember when I did a Watchman device by itself. And then more than 50% is a little bit, I don't know. It's kind of a very vague, mysterious, I do not know where we're going. I would put C and a half. One's 30. The answer is always C, right? Yes. If you don't know, the answer is always C. Now, interestingly, I would say, initially I thought it'd be how many ablation patients need a Watchman. Yeah, that's the other way around. Now, it's kind of flipped around. At least in our experience, it's the other way around. As PFA has proven to be very well tolerated, very safe, now it's more Watchman patients. If you're going to be in there anyway, you just do the ablation. Is that everybody else's experience? I think we're already at about 10%. So we'll see how it goes in the next few years. I agree with you, John. I think today when the patient comes in for LA closure, I think we completely re-evaluate. We look at it with a different eye because of the safety of PFA. Absolutely. All right. To how many of your patients do you expect to add a Watchman implant? So this is flipped. These are patients that you would have only done an ablation in the past. What percentage do you now consider a Watchman? Sorry. A, none. B, less than 10%. C, 10% to 25%. D, more than 50%. There's no C and F here. We've got the C and the F is where we are. How many A's? B's? C? D? I think we have to think about the results of the Champion trial as it comes out. I think that will change a lot of how I see that question. I think today in an indicated LA closure patient, I would say, you know, I would absolutely add it as a concomitant case. But if it's a first line indication, I want to see results from Champion as well. Great. Okay. Future clinical trials evaluating concomitant Watchman and Ferropulse. We have the Option A trial in Asia and then the Align AF. Do these trials excite you? Yes. Why? Well, I think for Align, it's a sub-study of the disrupt registry, which is a registry of the Ferropulse system for de novo afib ablation. So this is going to really look at real world data of doing concomitant devices. And I think that's going to help us understand workflow issues and help us understand TE versus ICE and some of the questions we've been bringing up. And so I'm excited to see how this enrolls and what we learn from this. Excellent. All right. Once again, thank you all for attending. We've hit our time and I hope you've had a wonderful time here in this session. Or maybe we created more questions than answers. Thanks and enjoy the rest of your time in San Diego.

electrophysiology

pulse field ablation

Watchman device

Salt Lake City

patient care

Option study

thromboembolic events

Farapulse system

clinical trials

concomitant procedures