Well, welcome, everyone. We are going to spend some time today talking about lead extractions. We have case presentations from the viewpoint of the electrophysiologist and the surgeon. Also talking about extraction of leadless pacemakers. And lastly, I'm also very happy to introduce the patient perspective. So thank you all for being here. We're going to start off with Dr. Tina Baconer from Stanford electrophysiology and the aspects of the EP and lead extractions. Thank you, Dr. Green, for the introduction. Hi, everyone. I have two fun cases, a lot of show and tell images and maybe a little bit of how our lab is set up for extractions, what our teams look like. And I know that's different in every place. So just a little glimpse of how we have it at Stanford. So first case is a 75-year-old gentleman was traveling out of the country in Frankfurt Airport, passes out, gets resuscitated, was found to have VT, gets cardioverted, and was put in a single chamber, single coil ICD in Germany. And subsequently gets diagnosed with hypertrophic cardiomyopathy. So since he has this device, he had appropriate therapies. And many years later, his generator was changed to a Boston Cy for early battery depletion of the biotronic generator he had. And most recently, he was noticed to have impedances over 2,000 ohms and was told that, gosh, you need a lead extraction. And that's why he was referred to our center. At the time, he was wearing a life vest given non-treated events, which I think is quite appropriate. And these are some of the episodes that you had. You know he has the same VT episodes. So we evaluated him, we set him up for lead extraction, and this is how our lab looks like. We do them most of the time, not every time, but with CT surgeons together. So OR sets up their own table with their OR circulating nurses in one side of the hybrid lab. And EP, this is our EP lab, and this is our implant table, and we have anything implant related. The funny wires that OR nurses hate to deal with, all of them stay on our device table on the implant table. We use laser, the laser console, as you see here, as well as mechanical tools. And then, of course, the device teams, as in every lab, support the team. And they hate that they have zero room in that lab to set up their own machines. So we start the cases together. If both the CT surgeon and I'm in the room, if someone is opening the pocket, someone is getting femoral access for bypass, backup, we have our EP fellow, we have the OR circulating nurses as well as the EP staff. We always do them with cardiac anesthesia, we always have TEE real-time in our cases. This is our hybrid room set up. We use a Siemens Pheno, which is one of the fancier hybrid fluoro systems that is out there. We often get, even if it's an extraction, if you're re-implanting, we get access before we start any of the extraction case, just so we have some wire as a backup for access. We use 21 gauge, we often use ultrasound. But I think it's important to look at these little pieces of notes that someone actually, without even not planning to do an extraction, did a venogram and noticed that the veins are open. So it's, I think, good to review notes or reports from earlier times, just to make it simple for yourself and save, for example, a venogram already in a long extraction procedure. Last five years, we started using femoral snares for most of the cases, which sometimes is important for retaining access and occlusions. But this case, just to make it simpler or easier to advance the extraction tools from above. I'm playing this video just to show you sometimes it is just a headache trying to catch these leads with a snare system that we have. It's much simpler, easier to snare them up above, but when we did that, it was catching the glide wire for access all the time. So then now you see us struggling forever and ever in the right atrial chamber. But once you grab it, we put our snare control fellow, aka the EP fellow, there to hold that sheath and pull traction. As you see, it's a little hard to see, but we decided to use a laser sheath for that case as we were getting set up in the groin. And this is just a show and tell of how big of a difference that pulling it down from the groin makes. So you can see how everything straightens and maybe moves away a little bit from the lateral wall once you're pulling things from the groin. And now the laser sheath, and I'm going to go through these a little bit fast to have some more time for discussion, but it was a little bit stuck here. It's onwards a little bit stuck there. I'm going to jump forward again, a little bit of an adhesions up in the SVC and the SVC-RA junction. And once you advance it to where your snare is, of course, you let go of the snare and then now all you have is the control from above. But I think the snare did a good job in making us get there quite easily, I should say. And then we release the snare, and this is now, again, a little bit of stuck adhesions in the mid coil there. And then as most of you, you hold your breath and wait. Sorry, let me see if I can just advance it to the end of the video. It looks like I can't, but forever and ever we waited for the tip to release itself, and that's a matter of a patient's game at that point. It is slow, okay, I'll skip that. But that was that case, pretty simple, straightforward, single lead, single coil, ICD, explant, re-implant. We did not put a balloon as backup as the CT surgeon is there scrubbed in with me, and we had the groin system set up to just help make it simpler and easier. And now I waited this much, I might as well wait for the lead to actually come out. So you actually trust me that we removed that lead. And sometimes they don't come out as elegantly as you hope it to be, as this case is not the best example, that it comes out a little bit violently as you see that it blobs out. And of course now we have the wire, we advance our sheets, and this is the new lead. All right, that was the simple one. Now this is case number two, again, not a complicated case, but interesting case. I thought you might come across something weird like this. So this patient is 59, had this LYNX system implanted in 2021 for bad reflux disease. These are magnetic beads that are in the GE junction that kind of stinches on that junction so it prevents reflux. I had never heard of this in my life. They told me these are just magnets. And you look at the CT and you see it exactly where you would put an ICD lead, right? So now we're all nervous, can we put an ICD lead exactly where magnetic beads are and would it even work? He got diagnosed with HCM, he met all the criteria to have an ICD, he had some mutations that were associated. And this is his event monitor. He has monomorphic VT that is thankfully non-sustained, but as long as 15 beats, they're all the same morphology as the singlets, the couplets, the triplets. That is making me a little bit nervous. And he has these runs that are not as AFib because they're all less than 30 seconds in the patch monitor, but that make me nervous for AFib. So he doesn't need pacing, this is his heart rate variation during the day. So you could argue if he needed a transvenous system or not, but seeing that monomorphic VT and maybe shorter episodes of what looked like AFib, we decided to do a dual chamber ICD. This is what looked like, this is an esophagogram that is, I just casually found it on PAX, I thought it was interesting to show you how close it is, the ICD lead and this. And because we didn't know how these things interacted, we did a DFT, we don't normally do DFTs, but we said, well, let's see how the detection is in the lower zones and it was fine. This is one year follow-up, it was fine. So then we published this in Heart Rhythm Case Report saying, hey, there doesn't seem to be a major interaction with this system. But what happened in about two years later is he came to the ER with chest pressure. CT showed a filling defect in the SVC, suspicious for a thrombus, so we recommended Eloquus and why don't we re-image, see if it resolves with Eloquus and we repeated it and it looked fine. We obviously know the filling defect was no longer present, we were like, great. And the symptoms are a little bit better at the time, at least he wasn't complaining. But about a month later, he started having recurrent symptoms despite being on Eloquus. We sent him to IR for a venogram and as you see here, the peripheral venogram, there's no more, I'll show you this one better, a lot of collaterals as you see and an occlusion right here in these extracted images. And this is what IR did, serial dilations with the balloons. As you see, larger and larger balloons and drug-coated balloons is what they tend to do these days and this is a venogram afterwards, looks great, right? The collaterals disappeared, you see now the path open. That was January. April, recurrent symptoms, the leads are still there. Of course, we don't really expect a miracle with just balloon venoplasty, but again, IR said, okay, let's do it again. Same procedure, same exact image, collaterals completely occluded, balloons, same things, drug-coated balloons, everything looks wonderful. So January, April, now we're in July, recurrent symptoms. We said, well, clearly not working and I'm not a big fan of stenting when the leads are there and jailing the stents in a relatively young patient. So we said, why don't we remove this and then put a subcutaneous ICD because thankfully, he actually, unlike what I expected, he didn't require that many ATPs or he didn't really develop atrial fibrillation either, so I was wrong in my anticipated arrhythmic events for him. So we planned him for a lead extraction and subcutaneous ICD and hopefully balloon venoplasty at the same procedure. So we kind of marked our sites before we started everything for the subcutaneous ICD. This is a three-year-old ICD. This is my titrial. I was hoping that my titrial would go all the way down so I can remove the leads, go past the obstruction and advance the lead. The leads aren't even holding. I didn't even unscrew the leads. They just came back with gentle traction, three-year-old leads. So what we did was we kind of made sure it's occluded. This is peripheral venogram to prove us that it's occluded. But of course, one trick you can do is to advance the snare from the groin to catch the bottom of the lead just so you can advance your titrial past thrombotic site just so you can then advance a wire because I'm not as skilled as the interventional radiologists to go across complete occlusions with wires that they're able to do. So this is now the gooseneck snare through an agilis sheath with a small curve grabbing the lead and then the titrial going over it. As you see now, the titrial is in the RA. I know I'm past the occluded segment. Let go of the snare, which is not as simple. Sometimes it gets stuck in that helix. And now we have a guide wire down past occlusion. We remove everything. I asked the IR colleagues, what balloon do you recommend? We open up whatever they recommend and we balloon the occlusion multiple times. And you see now the occluded segment is looking. This is how it looked before we started. Nothing past this. And now it's open. So we're happy. There's no more leads. We have ballooned it open and we're hoping, I asked my colleagues, they're like, now the leads are gone, it shouldn't reocclude ever. That was not the case. Two months later, he had recurrent symptoms of SVC occlusion, came back to IR and he said, I don't want a stent. I do not want a stent. So IR just balloons it open, drug-coated balloons everything. This is what they did. And then they said, just continue Eloquus. It was September, now we're in January. Recurrent symptoms. He has no leads in there. He's been out for almost half a year and had it ballooned twice. And he has a completely occluded SVC. This is their first image, right? You see the peripheral angiogram, complete occlusion that, oops, sorry, now it's playing. Collaterals, nothing going past from the subclavian. That's the beginning of the occlusion. They balloon it open. They open it up. And this is a cool image. I didn't realize they do this routinely. This is IVUS that they do in venous cases now at Stanford. You see that this is the lumen of the vessel now. And then you see that it's completely gone. So this is how they mark the beginning and the end of the occlusion to judge their stent length and where to start it and where to end it, which was neat here. And that's what they do, more balloons. And this is a stent being deployed based on the markers that they put in with the IVUS catheter. And now you see it's open. And then this is a post-IVUS looking now. You can see the stent struts and you see an actual open vessel around it. So this is where we are now. He hasn't had any symptoms, but it hasn't been that long of a time since this intervention either. Venous occlusion is quite rare, I mean symptomatic venous occlusion is quite rare even though occluded vessels are very frequent. And they may persist even after removal of these devices. And I tried to highlight the femoral approaches in two different scenarios that could be helpful. Thank you. So you're supposed to actually be logged in and you can, there was a QR code, but you should be logged in. You can ask questions through the app or we have just a couple, we have like one minute now if anybody wants to stand up and ask a question. But first of all, I think that this was a great presentation. This is a, when this happens, it's a real problem. And IR people oftentimes don't recognize that these are veins, not arteries. So things like drug, this is not an atherosclerotic process. This is a fibrotic process and a thrombotic process. So drug coded balloons are not going to be the answer here. How long are you going to maintain this patient on oral anticoagulation or antiplatelet therapy or are you not? Yeah, I'm not as familiar with managing venous occlusive disease, but I think our IR group is quite familiar with this. They wanted to keep him on Vlovinox for one month after their stent. So that was their recommendation. And then to move on to Eliquis. I think people, given the recurrent symptoms, are quite reluctant now to plan for stopping it within the next year. But I think it will be my call on them to dare to stop it. And given the stent in place, I'm a little bit reluctant. It's funny. Our IR people are the exact opposite. You don't have to put them on anything. It's like, no, no, no. I'm putting on something. This is a disaster if it happens again. Yeah. You don't have to deal with that. Individual practices are. Any other questions from the audience here? Oh, we got a couple here. Try to get something. What's your threshold for staging the bridge balloon? Bridge balloon. That's a tough one. We've been pretty bad at it because as a place, we've done them with the surgeons scrubbed in. And a surgeon getting into the chest and, you know, finding out the bleeding in our institution at least as fast as us getting the bridge balloon up and inflated. At least that was our original approach, which I know is not the right thing. So more recently, anything beyond five years, anything dual coil, anything that makes us nervous, we put up the bridge balloon, even if everyone is scrubbed. I'm going to give you one more question, then we'll have to move on. It was noticed that you did not use an outer sheath when you were using the laser. you think that would have been helpful in that case? If things are going smooth, good question. If things are going smooth, I don't use the outer sheath. If they're struggling at all, that the laser is getting stuck, stuck and not moving, then I love the outer sheath, I do use it. It's not like, oh, I hate the outer sheath, I never use it, but just this case was so smooth, we did it. Okay, I think we'll, thanks very much. Thank you. We are going now to hear from the cardiac surgeon and the perspective on lead extraction, and it's Dr. Jamil Bashir from St. Paul's Hospital in Vancouver, Canada. Welcome, everybody. Thank you for the opportunity, Ricky and Chuck and HRS. First off, let's see, oh, I gotta start this. I just wanted to say it's so nice to see this ongoing demonstration of collaboration between EP and surgery. I learned from a surgeon and a couple surgeons, Charles Kennegrin, who's now retired in Sweden, Roger Carillo in Miami, but I've also learned from a number of EPs. And I just, I don't think that people think of it in very siloed ways, but in fact, it's genuinely something that we all need to work together on. We always bring, we each bring something very unique to the table, and more and more, I'm seeing this sort of very collaborative approach. I remember when Bob Hauser's original paper came out, you know, and it was very worrisome that extractions were happening in the basement of some place in an EP lab when their leads were 20 years old. So it's great to see that we're in a different era now. So this is my, this is the way that I've evolved, and again, it's really a hybrid between learning from a number of great people, including Bruce Wilcoff, the late, great Bruce Wilcoff. So I only have one case. This is my patient. He's a 72-year-old gentleman with tetralogy. He's had two surgeries. The last surgery was about 30 years ago, was a mechanical aortic valve, and after that, developed pretty dense heart block. You'll notice that there's a couple of interesting things here, and I'll let you, I'll let you decide for yourself what some of them are, and then I'll reveal them later, but you'll notice the pacemaker's on the right side, and that's because he has a left, a persistent left superior vena cava. And so that's kind of an interesting thing, and this case is just from two weeks ago. It was the most interesting case recently, so I thought this would be a good one. His right atrial and his right particular lead are both failing. They're about 30-year-old bipolar leads, but the impedance was dropping. There was a bit of noise, so they were clearly not the greatest leads, and the big thing is that he's very dependent. So this is his venogram, and you can see that very clear, persistent left superior vena cava, massive coronary sinus, and then the other interesting thing, there's two here, and I'll see if anybody notices it, but one is that the right superior vena cava is completely occluded. He's got a narrow, tight occlusion of the right superior vena cava up at the top there, and again, very dependent, so in the end, when we took him to the operating room, he had nothing. You know, most people can get some rhythm out with isopryl, this guy had just nothing, which we're seeing a little bit more lately, I think. So, paste in the right atrium as well. So, you know, the conversation with this gentleman, of course, was a very detailed one, and I often spend about half hour, 45 minutes just talking about options and talking about risk, and there's a lot of options. Some of the folks in the room probably have more options than I do, but the options we discussed were a left-sided pacemaker going through the coronary sinus. We should be able to get a pacemaker in that way, but I was worried that we would cause damage to that new vein, which is all of the drainage from his head. We have had lots of experience with femoral devices, but I've really moved away from them these days because they're hard to extract if something happens, and you know, I'm not sure it's the best way to manage it. Micra or some other approach would have been a good approach as well, and that's just even not concerning about lead extraction, but I think our bias has been if we think that the risk is reasonably low, we are pretty aggressive with extraction, and so we had a very clear conversation with him about what we thought that risk would be in the setting of 30-year-old leads, and then the other interesting thing I think you noticed probably is that one of the leads was implanted from the right internal jugular. Not sure why. The old notes didn't say why, but it was. Risk-wise, essentially what I do and what my colleagues do is we look at our original CLEAR data, which was a retrospective study that was done across Canada, 2,500 patients, to really specifically look at complex patients with powered extraction and what the risk primarily of perforation was in that setting. So in this case, I would say, well, the leads are old, but he's had previous heart surgery, so I really think he's not particularly high-risk. Hi, Blondie. So there are some interesting things, though. He does have occlusion of the vein. He does have passive leads. He does have this jugular lead. So is he particularly high-risk? I'm curious to see what the audience thinks, but I would actually say he's primarily complex and not necessarily high-risk for extraction. So in that setting, and the other thing, of course, is very dependent, in that setting, I said, okay, this is what I think the risk will be, and he was interested in going ahead with it. So in the operating room, we prepared him initially. The RV lead was kept attached to the pacemaker because he was so dependent, and then I exteriorized the right IJ lead and cut down with a little counter-incision there so we could free that up. And one of the things I wanted to mention is in many different meetings, people ask, how do you control bleeding? And I think the big thing is, when we cut down to the venous entry point of the lead, I really try to make a pathway there that's less than an American or Canadian-sized quarter, probably like between a dime and a quarter, so that the tissue can be tap-and-added over where the lead goes in, and we use a large 2-O-proline to tap-and-add that with a purse string so that we could always control the bleeding once we get the leads up. We did, in fact, end up putting a permanent pacemaker lead in through the groin, because I worry that a temporary lead will fall off, so, and then we just throw that away at the end, so it's a little bit of a cost. So he ended up getting that while we were getting everything else organized. Tina didn't mention it as much, but lead control is absolutely primary with lead extraction, so being able to truly control the leads, and it's interesting to me because it's one of the biggest things that's changed in the last 10 years. There are more things that we have to be able to control the leads than we used to have. We've really moved to the Liberator locking stylette. It's now made by Merit. I find that they're just very, very nice to get right to the tip of some of these leads that tend to fall apart, like the 4470 and the 4471, and some of the new MRI-compatible leads, and the one tie is also super helpful in being able to strengthen a lead that you have then weakened. Similar to what Tina said as well, that we really spend a lot of time worrying about our operative risk and operative considerations, so here we are, the laser's about to go in, but we're in a hybrid operating room. We've got a perfusionist, the pump is there, the cardiac surgeon happens to be in the room, thankfully, and arterial line, neck line, et cetera. It's worth discussing, and maybe we can have a little discussion about it after. We don't really use the bridge balloon either, and I know a lot of people got excited about it, and sometimes I think people are afraid to say that they don't use it, but because we can get into the chest, we almost never use it, because it's $200,000 a year of bridge balloons that we have always thrown away, so we don't do it anymore. There are situations where we might use it, and maybe we can discuss that later, and we also don't tend to use TE. I think we have a pretty good idea of somebody's tap and adding, but we have it right there if we need to. So in this case, we started with the RV lead. We start with, I always tend to start with the laser, because I'm just used to it, and I get at the first part of the venous entry with the laser, and you can see right away, it just doesn't, it's just not gonna progress, and so very quickly, and I spend a lot less time waiting and progressing, I move right to using a different tool, which is a mechanical sheath, so we use a tight rail, and this is a 13 French tight rail, just because we didn't have an 11 on the shelf. We have a back order situation going on, and we definitely get much more progress with the tight rail. With the tight rail, I find it's absolutely a two-person job, much like the snaring, like you really cannot put forward pressure on the tight rail, and pull enough on the lead, and then deploy it at the same time. You just have to have a couple people for that, but it's very effective at getting through when the laser won't get through, and I'll just note that if you see that that, I'm gonna play it again, if you see the redundancy that develops in the right atrial lead, I won't address it now, but I'm curious from the panel if people are worried about that when that happens, because I don't tend to worry about it that much, but it does happen quite a lot. Really interested in what Chuck would say about that. So one of the things with extraction, I think, is really the awareness of the resistance of these different components upon each other. That's what creates most of the trouble. Lead on lead, lead on the device, and one thing that I teach our fellows is, at some point when you are progressing, don't be afraid to actually pull the whole system back. You're always pushing the extracting tool forward, and pulling the lead back, and sometimes you forget, oh, I just pulled the whole thing back, and you'll see it in the next, and then very often the lead actually comes free if you do that. So here's what happens. We keep going with the tight rail, and all of a sudden the RV lead loses its slack, and then just pulls out. Now the problem is the whole thing pulls back, and it almost pulls back enough that I can't get our access, but we do, in fact, end up, I just managed to have the tight rail in past that venous obstruction, thankfully, and then the next slide you see, we were able to get access, so I put a glide wire down below the diaphragm. Very dangerous if your catheter's not right in the heart to put the glide wire in, but nowadays, because I was gonna lose access completely, and I didn't wanna rely on the atrial lead extraction to get it, we tried, and I was very careful, and I was able to get access with that, so you have to be, I was pushing the limits a little bit on that one, I think, but there we are, we got that out, and then the next is we're gonna go after the atrial lead from the neck, so we're actually lasering right into the neck, and again, if the CT's okay, I think it's really quite safe to do this. Again, I always like to start with the laser, it's my preference, and it moves much better than with the other lead because you've already freed up a lot of the lead-lead binding, probably broken down the SVC occlusion, so all of a sudden, it actually starts to progress, and here it is, we get to the point where the atrial lead pops off the appendage, and then again, I pull both the laser and the lead back, and everything just comes out, and then we're left with, we put it, we had a glide wire in, and then we end up putting a septal lead in, Tyrex pouch, because we've done a lot of work, and good parameters on all the leads. Questions? That's great, thanks, Jermaine. So there are a couple of questions here. I'll start off with one real quick. First of all, I want to emphasize what you started. This is a team sport, right? It's not just you, the surgeon, and or an electrophysiologist together, but it's everybody else in the OR, everybody working together, and it's, anybody thinks they can just walk into any OR and do this has probably not done many of these because it's all about bringing everybody together. There was a, you asked about the prolapsing of the collateral lead. Sometimes what I do is put a little extra tension on that and straighten it out, and that lets me pop by it too. Sometimes that works very well. Do you worry about it though? Like, you know, it happens a lot, and of course it's pretty obvious why it happens, but I find it actually indicates maybe that it's actually fairly loose in there. And you've freed it up. And it's freed up so that you're. Right, when you go back in after it, it's there. So I always go after the easiest lead first, which there is one. 100%. And then that tends to free it up. So let's go to the audience. A few questions here. We'll try to get through a couple. They wanted to know, well, you actually did end up putting a temporine through the femoral. Why did you decide not to go with a leadless system in this patient? So we don't have a ton of experience with the VEER, which we could have gotten pretty good AV synchrony with. I've put lots of micros in in the lead extraction practice, but we're getting maybe 80% AV synchrony. Quite honestly, cost. Like, it is a factor. It's maybe less of a factor here, but we're not gonna drop that kind of money in that setting. And I don't think we're as comfortable with dislodgement and those kinds of things still in our institution. I think the leadless pacemakers are an incredible addition to our armamentarium, for sure, but when I was at one of the other sessions and they were putting in a VEER in a young patient, I think, this is very aggressive. So I still think there's lots of benefits to the systems that are there. I'm gonna fire a few questions at you real quick. Sure. Very short answers, because we're out of time. Did you go to the patient's head after the... We had, so when it was hooked up, you could see it was going over the collarbone, which is a very good sign that it's in the wrong place. So I just made a counter-incision. No, but did you physically move to the head or did you work from the side? Not much, not much. Now, what I do when it's a right side, I actually have the monitor here, and I'm looking at the monitor and extracting like that. And then everybody else is looking elsewhere, because I find from the right side, it's just nice to be able to basically look straight. Why did you start with the ventricular lead as opposed to the IJ lead? I mean, I guess a bit nervous about the neck. In the end, I don't know how many neck leads you've taken out, but I've taken out maybe 10 and none of them have been an issue. So it's pretty easy to compress. I think it's okay, but it was just more, the neck lead makes me a bit nervous. And there's a lot of great questions here, but maybe we'll get to some later. One more, the question about 1% risk assessment on a 30-year-old lead system, how did you come up with that? So that is directly from the CLEAR study, and I think that was in CERC-EP if I, it's my papers, I should remember. But, so we looked at 2,500 patients. We ended up creating a risk score from it. We actually published the methodology of the risk score, but we haven't published the risk score yet. But basically, we can calculate out based on that study what we think their risk would be based on parameters. So in that study, heart surgery, previous heart surgery was very protective. Female was very negative, so much higher risk. Multiple leads was very high risk as well. Diabetes was an additional risk factor. Low EF in that study. And again, this is our data, so we believe it. Low EF was protective. So we put all that stuff together and we make a very concrete risk assessment beforehand. Thanks very much. Sure, we'll move on. Yeah, maybe we have more time. There's a lot of great questions here. You know, we may have some time at the end to take some more questions. So we've heard leadless come up here now several times. So I think that the timing is just right for Dr. Tom Callahan from the Cleveland Clinic to now talk about extraction of leadless pacemakers. Thank you. All right, great. Thank you. I'm Tom Callahan from Cleveland Clinic, and I'll go through a case removing a leadless pacemaker. I'd like to thank Riki and Chuck, the other organizers, for the opportunity to be a part of the session today. These are my disclosures. I'd also like to acknowledge the fellow that was working with me on this case, Rob Derenbecker, one of our outstanding graduating EP fellows. To start, I'll just say that the patient was an international patient. Her journey started at her home outside the United States, and then she came to the Cleveland Clinic a little bit down the road. By the time she came to us, she's a 68-year-old female with a past medical history of end-stage renal disease. She's on hemodialysis, paroxysmal atrial fibrillation, and she was having sinus bradycardia with rates in the 50s and just sort of generalized fatigue. Her physicians at home made the decision to place a ventricular-only leadless pacemaker, so they used a micro-VR, and that was implanted about 14 months prior to her presentation to us in Cleveland. So it's a little unclear to me if her symptoms began after the micro-implant or if they maybe started even before, but one way or the other, in the early period after the implant of her leadless pacemaker, she was having this just sort of fatigue and just not feeling well. She had multiple presentations to the hospital, and eventually, at the request of her family, blood cultures were drawn, and they were positive for candida albicans. Subsequent cardiovascular workup revealed mitral valve endocarditis, and this was about three months after the leadless implant. She had a posterior mitral leaflet perforation, and then this large pseudoaneurysm of the lateral left ventricle. She was treated with eight weeks of antifungals and then oral fluconazole suppression, and her physicians at home were recommending surgery for the repair of the large pseudoaneurysm, but she was not interested, at least in having it there, so she came to Cleveland Clinic. So we started with the TEE, I'm sorry, transthoracic echocardiogram that showed mild mitral regurgitation. She actually had a preserved left ventricular systolic function, and then this large pseudoaneurysm, which you can see there, so this is, I don't know if, is it a core triventriculata? Is that a thing? I don't know if it's a thing. So this large, kind of scary-looking extra ventricle sticking off the side of the left ventricle. And here, TEE images, we start to understand the communication with this. You can see the flow in and out of this large left ventricular pseudoaneurysm, and then the 3D reconstruction shows us that in a little bit more detail as well. Cardiac CT was performed and really showed the same thing, this 4 by 4 by 3 pseudoaneurysm arising from the base of the infralateral wall of the left ventricle, and actually even appeared to compress the left circumflex artery. So here's just a couple stills from the CT scan. You can see her leadless pacemaker in places, actually a little bit more ventricular location than we would normally implant, but she was doing fine with it, wasn't causing her any problems that we were aware of. And then you can see on that right side the large pseudoaneurysm. So our multidisciplinary team came together, and the initial recommendation was the same as what she had received from her physicians at home, which was surgery, they recommended surgical repair. And she, again, was very adamant she was not going to have surgery for this thing. So plan B. So plan B was to basically do a percutaneous closure of the pseudoaneurysm, like using an implants-type closure device. But there was concern that even though she had cleared cultures, even though we didn't see any sort of material vegetation on the leadless pacemaker, there was concern that by leaving that hardware in place, it could be sort of a nidus for reinfection. So the thought was that perhaps if we remove the leadless pacemaker, give her some additional time, and then come back to place the percutaneous closure device. So they approached me to see if we could take out this leadless pacemaker. So before I got started, I wanted to understand whether she really needed the pacing, if we were going to cause her a lot more problems if we took it out. So didn't have a lot of time to work. But she was initially programmed just VVI-55, and with that, she had about 9% ventricular pacing. We reprogrammed her to VVI-30 and put a holter, and then just brought her back a few days later. And at that point, she was pacing 0%, and her average heart rate on the holter was 59 beats per minute, with minimum of 42 kind of when she was in sleep. And again, there was no history of long pauses or syncope. So I felt that we wouldn't cause her to fall off a cliff if we took this thing out. So the company line from Medtronic, of course, is that if their leadless pacemaker has been in place for longer than about 12 months, they recommend you just abandon the device. Turn it off. Abandon the device. And this was, of course, some unusual circumstances. And we were only at about 14 months. So I thought this should come out without too much trouble. You can see the leadless pacemaker again. It's sort of in a very apical position. And then the heart border abnormal with that pseudoaneurysm. Now there's a couple of ways that have been described to remove the micro, in particular, but leadless pacemakers in general. You can use the micro-delivery catheter. And with that, you just insert a very small snare. So it has to be at least 175 centimeters in length, has to be less than 3 French, and then the loop has to be at least 7 millimeters. So that cuts down on your options. But there are a couple options that you can use. And the idea with this technique is that you really try and get that cup on top of the retrieval feature. And then you engage it with a snare and cover it with a protective, with the cup. And in this case, you know, the delivery sheath really only comes with the micro. We weren't planning to re-implant. So I decided not to go with that technique. You can also use a deflectible sheath with a snare. For this, Medtronic recommends that you use sort of a bridging sheath, sort of a 12 to 7 French introducer inside the micro-introducer, just to minimize back bleeding. But you can use either a single or tri-loop snare. Recommended is at least 20 millimeters. But in this case, at least with that deflectible sheath, you don't have a way to apply any sort of counterpressure. And you are bringing that micro back across the tricuspid valve with those tines exposed. And then we described a while back use of the Avere tool for removal of the micro. And others have since reported the same. But basically, you can use this dedicated tool from Abbott. Has an integrated tri-loop snare. Has this soft protective sleeve that gives you a little bit of ability to apply some counterpressure. The micro is fatter. It's a little fatter than the Avere. But there's enough give, there's enough play in that protective sleeve that it will go over the micro. You've got towards the handle, you've got the deflection knob, a friction lock, and then at the back, you have a control knob for the snare to close it and even lock it. So sort of all the components that you need in one tool. And that's the way I decided to go with this case. I really like to use ice during the removal of leadless pacemakers. I think TEE would basically serve the same purpose. But I think it gives you a really nice way of understanding how this device is lying inside the ventricle. Things that you really can't understand just from simple fluoroscopy. There's a number of cases that I've done where you can really see that the retrieval feature is tucked underneath the valve or maybe it's really embedded between trabeculae. And so it'll change your approach if you can understand that from the outset. It also gives you a way to kind of navigate down to the device without using so much fluoro. And just like in a standard transvenous lead extraction, it does give you this early warning to developing effusion. I've not had effusions with removal of leadless, but I just like to be able to understand that quickly. So here you can see on ice we're approaching the device and it's way deep down in the ventricle down towards the apex. And then we're able to snare that with this retrieval tool. We get over the retrieval button and snare that without too much difficulty. And then eventually we're able to dock the device with the catheter. So at this point I like to try and advance that protective sleeve over the back end of the device. And that does a couple of things. It allows me to sort of push off any tissue, apply that counter pressure, but also it helps me understand if there's any tissue trapped between the device and the dock. In this case I kept getting stuck with that protective sleeve like right at the back end of the micro. And you can see here I've actually kind of opened a little gap between the device and the dock. I was concerned that maybe I had trapped some of the subvalvular apparatus and maybe that was interfering with my ability to get over the back end. I don't like that gap normally because it just creates sort of a little step sometimes, a little offset. But in this case I had released a little bit just to see if that would help me get over the back end of this thing. And ultimately it did not. Whenever I'm snaring or trying to advance that protective sleeve, if I'm struggling of course I'll go to different projections to see if I can better understand the anatomy and make sure that I'm coaxial with the device. And here I thought it was right on the device. It wasn't a matter of not being coaxial. And still I'm unable to advance this protective sleeve over the back end of the device. You can see that protective sleeve starting to billow as I'm sort of pushing against the tissue. So I'm really not able to move that adherent tissue or whatever it was that caused me grief. So I decided one last time maybe I had trapped some tissue within the snare itself. I released, I re-snared the device and then tried one more time and really ran into the same problems. So ultimately not able to get over the back end of this device. So then I decided to do what we all do, which is just pull harder. So I'm trying to pull a little bit here and it's really not coming. And this is similar to the technique that you'd use, right, with the deflectible sheath where you just snare it and you pull it and the tines aren't covered, et cetera. So I thought maybe just with a little bit of pulling this 14-month device would come free of any encapsulation. I pulled as hard as I was comfortable pulling and I'm still not freeing it. And I think because of this imaging you can't appreciate as well, but once we zoomed in I could see that the tines really weren't moving. The tines weren't flexing or bowing at all. I wasn't delivering that force to the tip of the device. It really appeared to be stuck on the more proximal portion. So here I go back to my ice imaging. You can see I'm sort of deep across the valve. I'm pulling. I'm not having any real success in getting this out. I pull a little harder and I've got everything kind of pulled back to the tricuspid valve annulus. And here I think you can start to understand what's going on, right? As I'm pulling, I'm starting to move the attached right ventricular free wall, right? It's just coming with me. So I'm really adhered to the body of the device and you can see that I'm moving that free wall. And I don't want to lacerate the free wall. I don't want to cause a bleed in this lady. So I couldn't really pull any harder. I thought what I'd like to do is just, again, try and apply a little bit more counterpressure and a stiffer sheath would allow me to do that. So the introducer sheath is long enough that it can cross into the ventricle and I thought that that stiffer sheath would allow me to have a little bit better counterpressure on that adherent tissue. But of course, the angles are all wrong. I just can't get up and around this corner to get this out. So what to do? I mean, the idea is she's infected. If it was just a non-infected device, I think I'd probably say enough's enough and leave it be. But the idea was she's infected. We want to minimize the chance of reinfection. So I really do want to get this out. Just like in transvenous lead extraction, you want to do everything you can to create mechanical advantage. We'd like to avoid these acute bends in front of your tools, right? You want to try and straighten things out as much as you can in front of your tools. I think we saw that nicely in our last presentation. And so that was sort of my thinking moving forward with this as well. And I thought the best way to give me a straighter shot was to go from the IJs. So we got IJ access. We switched the introducer sheath from the long 50 to the shorter 30 introducer just so I wasn't working in a different zip code. But here again, we're able to snare the back end of the device from the IJ. I'm able to dock the device. And then I advance that protective sleeve down. I kind of stopped the fluoro image before we get there. But it's no surprise that same thing happens, right? I cannot get over that adherent tissue on the back end of the device. So I advance the outer sheath. Here the protective sleeve is advanced to that point where we're having trouble. I advance the protective sleeve. I'm doing my best to straighten things out, and I get over the back end of the device. And here, I'm just holding that gentle pressure and counter-pressure, a couple heartbeats, and you can see we're able to slide past that adherent tissue. And then finally, I kind of hold the sheath in place and remove the device. At the end, we go back to our ice imaging, no TR, no effusions, she did well. And then a few months later, she came back to Cleveland Clinic, here's the imaging from the closure, and you can see those AMPLATS devices in place, closing the pseudoaneurysm and no flow across that anymore. A little bit of echo imaging showing the same thing, and then finally, the CT post-repair. So really, I think that what I'd close with is just that not all leadless pacemakers need to be removed, right? And infection rates are incredibly small, especially when we compare it to our transvenous infection rates. There are multiple tools and techniques that have been described. I think that's an area for further development. But we need to use the tools, the techniques, and the approach to create the mechanical advantage that we need to get these devices out safely. And then finally, additional imaging can really be invaluable to help you understand, you know, where this device is lying, how it's lying, and then what's causing you trouble if you're running into roadblocks. Tom, you make it look easy. Thank you. We're kind of over time, so we're gonna move on to our patient, and then if we have some time, we'll go to you for questions. So I would like to introduce Mr. Roland Skamovic, who's way at the end of the table. He is my patient, and we have gotten to know each other over the years because Mr. Skamovic is on the unfortunate end of having to have three lead extractions. This is for noise on the lead with insulation breaks on a couple of times and a need for upgrade once. And I think it is important. We do these procedures for our patients, after all. So getting to hear from a patient how he feels about all of this is an important part of what we do. So, Mr. Skamovic, the floor is yours. Thank you very much. After listening to this for an hour, I'm not sure I should have. You know, I've had my share of lead extractions. I've had five different pacemakers, but I'm here. I'm 79. I'm obsessed with golf, and that's probably what causes a lot of the problems with the leads. Let me take you back just a little bit, a little back story. When I was about 25 years old, I happened to be sitting around with some friends of my parents. By the way, I'm a lifelong educator, so my vocabulary is a little different than what you just heard. And I was sitting next to George, and he had this thing in his pocket, and there was a wire coming out of it and into the, between the buttons of his shirt, and I said, George, what is that? And he said, well, it's a pacemaker. And I said, well, what's that? And he said, well, it keeps me alive. Fast forward to 2010, when I had my first heart attack, and Dr. Peterson comes into the room, and he says, Roland, are you going to need a pacemaker? I said, hell no, I'm not wearing one of those with a wire coming through. I mean, that was my image of what a pacemaker was. Obviously, that's changed. I feel extremely fortunate to live when I do live, because pacemakers have obviously come a long ways. I was out there in the exhibit room, and I saw one that had a hand crank to it, and I thought, wow, what happens when the guy runs out of gas and he can't crank any further? So I think the most important thing that I could share with you is that for all of you in the room, another case is another case. And you have multiple cases every day, every week, every month. For us as a patient, it's the case. And so therefore, having a trusting relationship with the physicians who are going to be working on you is paramount. It's just totally important. I feel very fortunate that Dr. Green, Dr. Polema, some of the other doctors that I've had occasion to be connected with at UCSD, take the time to establish that trust. And if it wasn't for that, as a patient, after seeing what you guys kind of deal with in the OR and the little complexities that come along, I don't know that I would be going to sleep feeling, prior to the procedure, feeling confident that everything was going to be okay. It's been okay every single time. And I think if you're looking at a patient next time, and I know it's the first thing you look at is the age and the gender, if you would just remember that. Remember that, how important the trust element is. I wonder how many people in this room have had a pacemaker installed. That's what I thought. None. So, until you have, you don't really quite fully comprehend what we as a patient are anxious about, nervous about, concerned about, you know, going in. And it always, I always get a kick out of talking to physician friends of mine who, for the first time, have experienced any kind of a procedure, whether it's something on their back, their knee, their elbow, you know, maybe an internal organ, and they suddenly, the light goes on as to what it's like to be a patient. And, you know, that's, for us, that's what, that's what we worry about. I'm fascinated by the hitches and the glitches that go on in that OR that I was completely unaware of, thankfully. Nobody wakes you up and says, oh, by the way, we got to go in a different way. You just do. The only surprise for me was, in the last one, I had to have a third lead put in, and the pathway across my neck wasn't there. So I had to come back a couple weeks later, and a third lead was installed via the rib, through the ribs. I remember Dr. Polam was saying, listen, if I can't spread them apart, I might have to snip, and you won't like me. Luckily, he didn't have to snip. But the recovery for something like that is fundamentally more intense than just having a regular lead replacement. I was in the hospital for four days. There was a tube hanging in a bag, hanging out on my side. So it's a different experience having that third lead put in through a different avenue than what you would normally experience. Nowadays, when I get my regular message from UCSD that the vector download has happened, and I see Dr. Green's message that she's looked at and everything's fine, and there's nothing in there to indicate that there were some strange sounds picked up, I'm really happy. Because as soon as I see that there were some strange sounds picked up, I wonder why Abbott hasn't developed a lead that doesn't rub. But I won't give up golf, and I know that that's part of the problem. It's something I love to do, and I think as time moves on, you're going to experience more and more improvement in the technology of leads and pacemakers, and some of these problems will just go away. That's it. Thank you very much for sharing that. Thank you. So we only have a few minutes left, so if you ever watch Jim Cramer on CNBC, we're going to do the lightning round here. So these are going to be real quick, because I really want 10-15 second answers at the most. First of all, I'll answer the first one. French size of the sheath for micro removal, that's a 27 French sheath. It's the same sheath that was utilized for the implant. Tom? Are those packaged separately? Yeah, they are. They're separate. Yeah. But you've got to put a 16 French introducer into it, because it'll leak back if you have a smaller, like an Angelus or something. Did you worry about the extraction because the tines on the CT scan appear to be outside of the heart? Oh, sorry. Yeah, that's a good question. I wasn't that worried. I mean, I think that these micro probably end up in, you know, the anterior AV groove or one of the AV grooves much more often than we understand. So I wasn't too concerned about whether it had a microperf or something. Even when we have leads that have perforated and we take them out with transvenous lead extraction, it doesn't usually cause infusion. So I wasn't so concerned about that. May I add a word to that? It's scary how often the CTs look like that, that they're in the apex and outside the heart. We just don't get enough CTs. Yeah. And same thing with leads. Leads oftentimes appear to be perforated and they are not. Did you consider rotating the extraction catheter back and forth to break up the connective tissue before you went to the IJ approach? So if I could have gotten a sheath, you know, an independent sheath like that outer introducer, I might have considered a little bit of rotational energy. But once I've captured the micro, I can't really, I didn't feel comfortable rotating that sheath because I'd be rotating the distal end with the tines as well. I didn't think that would be as safe. Jamal, do you use a purse string around every time you do a lead extraction? Yeah, absolutely. I mean, and I've often been asked like how do you, that people have had issues with controlling bleeding and unless the CVP is 30, which it, you know, something else is probably going on if it is, it always. Yeah, I do 100%. Just don't dissect too much. You don't want to do it after you've pulled the lead out because now you're dealing with a bloodbath. Tom, how long did you persist from the femoral approach before you went to the superior approach and then how long was the procedure total? You know, it's been a few months now. I don't recall the exact times. You know, I think you can see from, you know, the release, the re-snaring, you know, I think I was probably working for at least, you know, 45 minutes or so from the groin. It really didn't take long to get to the device to snare it. You know, sometimes that can be a challenge, but we were able to snare it pretty quickly and often these will come out in minutes. So I think probably 30, 45 minutes of time working and trying to get up and over and, you know, that was a fair bit of time from the femoral approach and then it was pretty quick once we got to the IJ approach. I think once we sort of prepped the area and got down to it, it slid out very quickly. Tina, how do you manage anticoagulation in patients with mechanical valves undergoing lead extraction? Oh, tough one. We're doing the rough route of pre-admitting them, getting them on heparin drip if it's a mechanical mitral valve. Maybe Lovenox if it's a mechanical aortic pre-op and then onwards they stay in until their INRs are in range. So very long hospital stay. Well, I think you just opened a can of worms there that would take us about 10 minutes to go through. Our approach is actually very different. We actually will do them with an INR under two and a half and there's actually some data to support that and Lovenox can be a whole other kettle of fish, but we're not going to have time to have that debate right now. Coming in though, not afterwards. I mean coming in, yeah. No, no. I'm talking about the actual extraction area. And we do them also anticoagulated. Yep. Yep. INR less than 2.5. Yeah. We really don't like heparin. It's a terrible drug. Yeah. A little Lovenox problem. Bashir, a really important question. Patients had prior open heart surgery, do you put a femoral arterial line in and a femoral venous line so that you can jump on a fem-fem bypass if you feel it's going to take a long time to get into the chest? No. But this is the one situation where I feel like a bridge balloon could be helpful. So in our study, it was quite clear that having heart surgery was protective, but if you do have a perforation and they've had heart surgery, you're in real trouble because it's not easy to get in there. The reason we say that when the heart surgeon's in the room, we don't use the bridge balloon is because we can open the chest within 60 seconds, literally, and you can always fix those people. I tell people there's no risk to their life when we do that because we can get in, but you can get into real trouble if they've had heart surgery before because you just can't get in quickly and you can't fix it quickly. Those are usually SVC tears and so that's why we don't laser in the SVC. I didn't mention that before, but also that could be a good use for the bridge balloon. And in those, like a really high risk, female, really old leads, multiple leads, et cetera, you know, like an 8% sort of perforation risk, then I might consider that. Our surgeons actually like us to have just an extra arterial lining below that they can jump in real quick. If they've had prior bypass, then they can take their time and they don't necessarily have to, you know, kind of tear into the chest. All right. We are, I think, at time. More great questions here. Great panel. Again, thanks. Thank you to our patient for being here and sharing. That was very enlightening. Sure. Yeah, go ahead. How many of you guys played with Legos when you were kids? Thank you all for attending. Enjoy HRS. Thank you.

lead extractions

pacemakers

electrophysiology

cardiac surgery

hybrid operating room

pre-procedure planning

leadless pacemakers

intra-procedural imaging

multi-disciplinary approach

procedural advancements