to San Diego and Heart Rhythm 2025, the 46th annual meeting of the Heart Rhythm Society. If you have not already done so, please download the HRS 2025 mobile app from your preferred app store. This is how you can participate in live Q&A during sessions. Please scan the QR code on the screen to access this session's Q&A. When using the mobile app, log in with your HRS credentials. Please note that visual reproduction of Heart Rhythm 2025, either by video or still photography, is strictly prohibited. So we'll start today's session. My name is Justin Lee from the Cleveland Clinic and co-chairing the session with me is... Yeah, I'm CK Ching from Singapore. And today we have an exciting session. We talk about very practical questions regarding lead extraction. We have amazing speakers today, so please tune in. And so for the first speaker. It's a great pleasure to introduce the first speaker, Dr. Sean Brocconi, who will talk on when to extract and when to abandon non-infected leads. Over to you. Great, thank you. So I think this is actually a really challenging discussion and I'll sort of lay out some of the framework and some of the data and maybe during the Q&A, it'll be good to get thoughts from the rest of the panel on how to approach these patients. But I think there's certainly not a uniform approach to managing these patients. And the scope of the issue is really quite large. First of all, abandoned leads are not tracked well and so there's no CPT code or ICD-10 code for an abandoned lead. And so we don't really know exactly how many abandoned leads there are out there, but the estimates are that there may be as many as 600,000 abandoned leads out there in the community in the United States. And we know that when providers have the opportunity to extract a lead or abandon a lead, the vast majority of time, about 85% of the time, they actually choose to abandon the lead. And one of the questions is, where are the patients in all this? Are the patients getting a choice? Are they engaged? Are they involved in the decision making? So I always think a nice place to start is what do the guidelines say? And so this is a clip from the 2017 HRS consensus statement. Obviously, the lead extraction guidelines are being updated right now. And so there may be more updated information on this coming in the future. But at least for now, what's said is that there's a 2A indication for lead abandonment or for lead removal. And so it's really a 2A indication to do either one in the current guidelines. And when they present the data behind that recommendation, there's sort of three studies that at the time of that guideline statement were available for discussion. And so I thought it'd be worth just reviewing those quickly. So the first one is a retrospective study out of France from a single institution in France. And the mean follow-up for the patients in that study was 3.2 years. There were only about 70 to 80 patients in that study. 34 of them had abandoned leads and 47 of them had extracted leads. And they looked at things like inappropriate shocks after abandonment versus extraction. The extraction group numerically had fewer in terms of percentage of patients who had inappropriate therapies. It was not statistically significant. Really none of these factors were statistically significant. The complications related to the intervention of capping lead and abandoning it versus extracting lead, there was no statistically significant difference. So it sort of seemed like either way was an approach that could be taken. And then there was another study from the UPMC group that was also retrospective data. There were almost 300 extraction patients, about 200 abandoned patients. And the median follow-up was three years. And it looked at what the rates of unanticipated procedures after this decision of extracting or abandonment was. That's the figure on the left-hand side. It looked at what the cumulative survival was in these patient populations. And neither one was there a statistically significant difference. And then Dr. Zeitler published this really nice paper out of the NCDR database, looking at Medicare data at one year post-procedure. And it looked at a variety of endpoints sort of all shown here, including mortality at 90 days at one year, looking at in-hospital death. And again, there was no statistically significant differences between the explantation and abandonment groups. And so we actually did a Medicare analysis after the guidelines were published, trying to sort of dig into this issue a little bit more. And this was a much larger, this was a large data set, at least relative to the two single-center institutions from France and UPMC that I showed. But again, similar in terms of scope to the NCDR analysis that Dr. Zeitler did with longer follow-up. But basically, there were about 5,700 patients that had capped and abandoned leads, and 1,100 patients that underwent extraction in this sample set. And these patients were in their 70s. Again, remember, this is a Medicare patient population. When you look at the types of devices that were in place, again, we didn't have, I show here how many patients had a pacing lead and an ICD lead. They're not mutually exclusive. And the average dwell time was about three to four years, so not terribly long dwell times. The majority of the providers that were caring for these patients were cardiologists. There were some surgeons involved in their care as well. And when you look at the five-year outcomes for extraction versus abandonment, I have both the unadjusted and then below that the adjusted for each of these endpoints of all-cause mortality, device infection, lead revision, and lead extraction. And you see that really the only one where there was a statistically significant difference in the adjusted cohort is the device infection group. And so there was a 22% lower rate of subsequent device infection after extraction versus after abandonment. And the concept behind this is that the more hardware that you leave in place, the more hardware there is for bacteria to grab onto and for you to ultimately have infections. And so the question is, how much does timing of extraction matter? Because one of the concerns, obviously if you have a device infection and you're abandoning leads and then you subsequently have a device infection is it's gonna be harder to get that hardware out the longer that it's been in. And that's sort of demonstrated here nicely in the CLEAR registry, this Canadian registry, eight centers in Canada, and 2,300 patients. This is sort of the most recent multi-center data that we have. And they looked at, in a multivariable model, what factors predicted perforation and complications at the time of extraction. And as you can see, both the number of leads and the age of the leads both contributed heavily to the risk of perforation. So again, the concept being the more leads you leave behind, the more leads you have to take out. When they subsequently get an infection, the longer those leads have been in, the older they are, the harder they are to get out. And this story also sort of is shown in the data from Cleveland Clinic. And we know that there's this increased infection rate at five years, as I mentioned. And then once patients are infected, if they have abandoned leads, it's significantly harder to get that hardware removed and get it out. And so you're five times more likely to need femoral extraction tools if you have abandoned leads versus if you don't. You're four times more likely to be not completely successful in getting out all the material if you have abandoned leads. You're nearly three times more likely to have a major adverse event if you have abandoned leads. And so having these abandoned leads in place is problematic for when extractions do need to take place. I think one of the questions among providers that say we shouldn't be extracting these leads is how often is it that these leads fail? Certainly infection is one issue, but what about lead failure in these patients? And this is some data from the Danish Registry that had a little bit over four years of follow-up. And basically what it showed is the rates of needing extraction for non-infection indications, which is on the left-hand side here, for non-infection indications is relatively low. So their argument was that within their data set, 90 plus percent of patients that had an abandoned lead did not end up needing to have that lead removed. And it is a little bit different in younger patients versus older patients. And I show they break that down on the right-hand side. This is the younger patient population. You can see the red line is now the infectious indications for extraction. The green line is the non-infectious indications. And again, it does seem like maybe in the younger patients, they have higher rates of ultimately needing to get this hardware taken out. I just don't think, the challenge with this data is that I'm not sure that four years is enough for a long-term follow-up. And so when you look at the data out of Olmstead County, when you have three decades of data, what you show is that when you go into somebody's pocket three or more times, there's a 25% risk of infection. And so the rates of infection among those patients are incredibly high. And when you're going in to make the decision to abandon or to extract a lead, you're already in the pocket a second time. And so the question is really, is this person gonna live to their next generator change or are they not? And I think one of the key questions, ultimately, in the decision to extract or abandon is what's really the true risk of extraction? I think for many providers that don't do extraction, there's a misperception that the risk of extraction is significantly higher than it is. And so when you look, and here I've sort of put some of the risks of different types of procedures that we do in invasive cardiology. And when you look at AFib ablation, for example, at least prior to PFA being available, the rates of major adverse events, the procedure-related mortality is really very similar to what we see in lead extraction. And we never think that AFib ablation, or almost never think AFib ablation is too dangerous to do. So I would say in conclusion, the majority of non-infected leads are capped and abandoned when they're taken out of service. There's a misperception regarding the risk of lead extraction that it is riskier than it should be. My concern is that patients are not being engaged in the decision. And so I do think it's really important to engage patients in the decision-making regarding extraction versus abandonment because it's not a clear-cut black-and-white answer. And it comes down to what the risk profile of the patient is. A lower-risk, younger patient, I believe, strongly should have that lead taken out. And patients that are at prohibitive risk for extraction or higher risk for extraction, those are ones that we really need to think harder about whether we wanna be doing that. Extraction at the time of taking a lead out of service does decrease the risk of downstream infections. And ultimately, abandoned hardware results in more complications over time for these patients. Thank you. Thank you very much, Dr. Porcini. Next, we'll have Dr. Emily Zeitler from Dartmouth talk to us about when to extract in tricuspid regurgitation. Thank you to the chairs for having me. And thanks, Sean, for setting the stage for the rest of our discussion today. I'm Emily Zeitler and delighted to talk about, this is one of my favorite topics, so I'm happy to talk about when to extract leads in tricuspid regurgitation. Actually, this was the title that I was assigned, but what I'm actually gonna talk about is when to extract leads in tricuspid regurgitation prior to transcatheter tricuspid repair. Because I think, without the plan for tricuspid intervention, how to think about lead extraction for the diagnosis of TR alone is maybe too much for however much time I have. So we're just gonna talk about it in the context of TTVI. Or I am, anyway. I'm gonna start with a case. This is a patient that I saw pretty recently. It's a 71-year-old with a history of hypertrophic obstructive cardiomyopathy. He had a prior myectomy with maize and then developed sinus node dysfunction. He got a dual chamber pacemaker and really had severe TR throughout this course. Sorry, he developed severe TR and then was seen by the structural heart team, was offered or considered for tricuspid valve intervention. He was screened for some of the protocol-driven tricuspid valve interventions, but was excluded, didn't meet inclusion criteria. But then when the device became commercially available, he was reconsidered for a commercial implant. So because he had a lead across his tricuspid valve, he was referred to me for a lead management consultation. When I saw him, he was pacing in the ventricle three quarters of the time. He had longstanding persistent AFib, so his atrial lead wasn't being used. And his leads and battery function were normal. I'm gonna make everybody a little bit dizzy here. I'm just gonna play, try to play these. So here's a CT scan. The point I'm making with all of these images, and I'm just gonna play them all, is I think imaging is so critical to evaluation of patients with leads across tricuspid valve when you're thinking, when somebody is thinking about a tricuspid valve intervention. So what you maybe saw as I scanned through the CT scan, there's nothing really to write home about other than this giant right heart, but the leads are kind of in expected locations for traditional dual-chamber pacemaker implantation. All these echo images, you can see just like massive dilatation of the annulus. I sat down and reviewed all these images with some of my most trusted imaging colleagues, and we really felt like it was an annulus that was the problem, and the lead was interacting with the tricuspid valve, but probably was not the problem. And so it made sense to think about how to manage this lead in that context. And a little bit later, I'll share with you why that is critically important when we think through an algorithm for how to manage leads in patients who need tricuspid valve intervention. I probably sabotage myself with all this imaging. See if I stop them all. There we go. So as I shared with you, we felt that his imaging suggested severe functional TR, and the lead and valve were interacting, but again, there was no evidence that the lead was really the problem here. And so I offered the patient system extraction. The dwell time was relatively short. The patient was a reasonably good candidate for extraction. And then to allow him to, and then place a leadless pacemaker. He was, again, in what is likely permanent AFib at this point, so we could pace him leadlessly, and he could go on and have tricuspid valve intervention. He took in that conversation. Actually, it was a really nice conversation, and then he left and went and saw his community electrophysiologist, actually. And this is a direct quote. He said, the quote from his community electrophysiologist, he followed with Dartmouth recently, and they were recommending heroic measures to treat his tricuspid valve regurgitation, including extraction of his pacemaker, implantation of a leadless pacemaker, and some sort of percutaneous valve intervention. And I mean, I was speechless when I saw this, because you have to be living under a rock to not see the tsunami of tricuspid valve intervention. At least that's my experience. And so I was really surprised to hear a colleague, an electrophysiology colleague, sort of not acknowledge this problem, especially in this particular patient. And so, anyway, I'll get back to my patient in a second. But I wanna do a bit of a discussion of this problem in general. So we know that severe TR is significantly more common in the setting of a device across the lead, but I'll spare you the journey to figure out what that number is. It's like 10 to 40%, maybe, depends how you define it, where you look, how often you look. But it's not trivial, and certainly higher when there's a lead across the valve than when there's not. And there's a lot of potential contributors to TR in that setting, and I've listed a lot of them here. And some of that makes sense from a physiologic perspective, and some of it makes sense from a mechanical perspective, and maybe some of it doesn't make sense at all. But we know there's a lot of potential reasons why patients with leads across the valve, or with RV pacing, can get tricuspid valve regurgitation. And this is what I was getting at before, is how do we figure out if the lead is the problem? I think it's a really hard question to answer, and even when we look at the results from the TTVI studies, the quoted number of patients who have lead-related TR, I'm not sure I always buy it. I mean, how do we know for sure that the lead is causing the problems? Oftentimes, we remove the lead, and then we look at the annulus, and we can see that, oh yeah, that thing is super stretched out, and the lead was never the problem to begin with. And so it can be really difficult to make, and I don't wanna be flippant about it. It can be really difficult to make this call. But echo really is the primary modality, I think, to assess tricuspid valve disease, with TE having some advantages over transthoracic echo. There have been some really nice descriptions of how to make this assessment using these imaging modalities, including this idea of watching the lead in both systole and diastole, looking for calcification at the lead valve interface, and how does the lead travel into the ventricle? Does it hug the septum? These are all indications that the lead may actually be contributing to or causing the tricuspid regurgitation. And what about left bundle leads in particular? This is a little bit tricky, because there's a lot of, I mean, just like with traditional leads, there's a lot of variability in how these leads are implanted, and we know that that elbow hanging across the tricuspid valve might be contributing to mechanical TR. It might be improving the TR that results from RV pacing, but how it affects the mechanical function of the valve, I think, remains to be seen. There's a lot of reports about this interaction, but I'm still not quite sure what the right answer is. It does seem that the distance between the tricuspid valve annulus and the lead implant site likely has some predictive value in how much TR there is, especially if you're more proximal to the annulus. And can lead removal improve TR? Well, yes and no. Binding of the leads at the tricuspid valve can occur in a significant number of patients, and so when you remove leads, you can get worsened TR, although the rate of that, again, hard to quantify, but relatively low, and certainly surgical TR is even lower following extraction. If you do enough extractions, you're likely to end up with a picture like this one that I have, where you pull out part of the tricuspid valve unintentionally, so there is certainly the risk of surgical TR following extraction, but that risk is extremely low. And all of the factors that we know of for making extraction more dangerous are the same factors that increase the risk of TR following extraction. Longer dwell time, more leads, et cetera. I have no timer, I have no idea how long I've been going, but. Okay, so just cut me off. So when it comes to the emerging field of transcatheter tricuspid interventions, It's like, you know, we really have no idea. I have no idea really what to make of it because the trial protocols were so variable, really inconsistent in how patients with leads were both monitored and whether or not they were even counted. I mean, what I'm showing you here is in TTBR, so tricuspid valve replacement, there were studies where they didn't even tell you how many patients had leads across the valves, which suggests that maybe they weren't watching or monitoring those leads. And, you know, I think this really highlights this discrepancy between, which is, I think, always a problem for extractors, weighing the known risks of lead extraction against the unknown risks of entrapment. I think we're learning a lot. We learned today, we saw some presentations today about what those risks of entrapment are, both acutely and we'll learn more chronically, but it's always tough when you have known risks and unknown risks. It's like, I tell my patients, it's like apples and bicycles. But the problems with jailing the leader are relatively obvious, I think. You can have acute problems with lead malfunction and you can have more difficult long-term problems with lead infection, in which case, it can be extremely difficult or impossible to remove the lead. And this, you know, we're gonna, again, learn more about this over time and it almost certainly has a lot to do with the lead design. And I'm just showing an example here from the Anderson paper of a lead that's been entrapped by a tricuspid valve replacement. You know, just, I think the EP community has been pretty vocal and certainly lead management community has been pretty vocal about the problems with lead entrapment and tricuspid valve replacement. And, you know, we see this onslaught coming of tricuspid valve intervention and have raised the alarm and I think that's great because there's a lot of work being done to try and address this. But the problem could be really big. I mean, these are back of the envelope calculations, but if there's 1.6 million Americans with TR, if, you know, if all of them simultaneously got a TTVR and 30% of them have a lead across the valve, that's a lot of jailed leads. And so a lot of lead failures and a lot of potential infections. And, you know, back to, I can go through this quickly because Dr. McCorny very nicely made the case that extraction is not as dangerous as many people would think. I mean, as my colleague in the community who called my proposed plan heroic, I mean, I would suggest that if that's the case then maybe effibrillation is also heroic. So I'll just mention, as we all know, TTVR was recently, the coverage for TTVR was finalized and I'm mentioning this because the coverage includes the requirement for ongoing study in the post-market space and that study protocol must include an electrophysiologist. I think that's great. I hope that these electrophysiologists on the HART team also have some understanding about lead management because as I've shown you, you know, not all people, not all electrophysiologists can think about lead management in the same way. And so I think we need to be cognizant about how we approach these questions. And then again to, you know, it's not just tricuspid valve replacement, there's also clipping, so end-to-end repair, there's this tear, this technology has not demonstrated the same impact, the same injury to leads as TTVR. So we have a little, we have more reason to be comfortable with this, I think. And this technology has not yet been formally covered by Medicare, but there's proposed coverage and it's very similar to TTVR and does require a HART team with an electrophysiologist in the post-market study. Oh, this is a showing, what I think is really interesting, and I'm showing an echo here of a patient who had tear and then required pacing. And I think that presents a whole other set of challenges. And this was a case where a patient had tear, came back a couple years later and we had to sort of get a micro through there and it was kind of fun. So there are lots of options to avoid this and this group knows this. When we need to replace a tricuspid valve and you need to remove a lead, you need to get the lead off the tricuspid valve apparatus, there are lots of options to try and deliver Brady and tachytherapy to these patients without crossing the valve. And I'm gonna skip this, but I will say there's a lot of algorithms to try and help us think through how to approach these patients. And this slide represents a compilation of a variety of different algorithms. So the Hahn paper was from the Heart Valve Collaboratory published last year and then earlier this year, ERA published another sort of consensus statement on managing leads in tricuspid valve disease and then this was my attempt to kind of pull them all together. And the bottom line is that when we think these patients tend to be frail, and so they may not be good extraction candidates, but we should at least think about their extraction candidacy and the top set of boxes, the benefits and risks of extraction, that's how we can help us think through the extraction part of things. But then we also need to consider there are a lot of patients in whom jailing is really okay and these red flags and yellow flags come from the ERA consensus statement thinking about reasons why it makes more sense to extract versus not. So in follow-up, the patient that I shared with you, we offered him system extraction and replacement. He had estimated low risk of extraction and low but non-zero likelihood of TR improvement and patient declined the extraction. He was offered TTVR with jailed lead. He declined that as well and he's stable on medical therapy so what do we know? I don't know, maybe we shouldn't be doing any of this at all. So sometimes lead removal is the best strategy, sometimes it's not. But multimodality imaging is super critical and I'm really gonna have to get up to speed on reading ECHOs and TEs again because it's really, that's how we can figure out how best to approach these patients, I believe that. And then taking into consideration all of the things that we always think about for lead extraction, especially in these very frail patients. And then, I don't know, maybe no one's asking but I wanna know, does the patient really need the TR intervention? So waiting on data for that as well. So thanks very much. Thank you. Thank you very much. In the interest of time, we will move on and we will take questions at the end of all the lectures. Next, gives me great pleasure to introduce Dr. Parashit Sharma from Cleveland Clinic, Florida and he will talk on how to extract luminous leads. Thank you. Thank you to the Heart Rhythm Organizing Committee for this very kind invitation and to our chairs for having me here. So I'm gonna be talking about extraction of luminous leads. As we're all aware, those are my disclosures. So the luminous lead we are all referring to is the Medtronic 3830 Select Secure Lead. Before I talk about this lead, it's important to understand that this is not just a lead that is associated with conduction system pacing. This lead has been around since 2005 or so, was originally designed for pediatric implantation given its French size but really happened to be now in adult EP because of its use in the conduction system pacing space of the his bundle and the left bundle region and has also been implanted now in the atrial space with Bachman's bundle pacing and in the right atrial appendage as well. So everything we're gonna talk about is gonna apply to extraction of these leads for most of these indications but the more common space you'll see it in adult EP is going to be with conduction system pacing. So this lead has a 4.1 French luminous body and it's bipolar in design with the tip to ring electrode being nine millimeters in terms of spacing. It's got a titanium nitride coating on each of the electrodes. The helix is actually got a coating with steroids so this is not steroid eluting as opposed to your typical other leads which are steroid eluting. It is MRI conditional and it comes in varied lengths, 49, 59, and 69 centimeters. The traditional conduction system pacing lead is about 69 centimeters given the need for delivery catheters. When we look at the cross-sectional design of this lead which is critical to any extracting physician, understanding the cross-sectional design of the lead is critical to understanding what tools we're gonna apply when we're extracting these leads and how the lead might behave when we use different tools. So here you have a central cable with ETFE jacket, a silicon tubing that surrounds the central cable surrounding which is the outer coil conductor and then the polyurethane tubing around the lead itself. The overall tensile strength is somewhere between 11 to 14 pounds and we'll see how this compares to other leads. So this isodiametric lead body construction gives you a better ability with higher tensile strength for removal and the cable is designed to minimize the stretch of the lead body during extraction. So just case in point, here is a traditional extendable retractable lead with a lumen and you see stretching of this lead with applied force and here is a 3830 lead with before and after pictures of force application. The inner conductor stretches about 28.6 times greater on a lead with a lumen or stylet-driven lead as compared to the lumen-less 3830 lead. Again, highlighting the same differences, here is the lead with the lumen and the 3830 and you see here in this video how easy it is to really stretch a lead that is stylet-driven and then on the right here, we compare different lead-locking stylets and the tensile strength that we are able to achieve in extracting leads using these lead-locking stylets and a 3830 without a locking stylet really falls in the LLD1 category with a tensile strength of about 11 to 13 pounds. So let's talk about a couple of cases. So here's a 78-year-old gentleman, history of end-stage renal disease, non-ischemic cardiomyopathy with a blockage FEF, presented with 2s to 1 AV block, underwent dual-chamber pacemaker implantation. The lead was implanted at the his bundle. Threshold at implant was very, very acceptable, .5 at one millisecond with selective capture. Two and a half years later, presents with staph bacteremia and is now indicated for a system extraction. So here you see we've already implanted a micro. We have an ice catheter just for monitoring and with very gentle counterclockwise manipulation of this lead and gentle traction, lead is easily extracted with just gentle manual traction. So something very straightforward. Here's another case of a 68-year-old gentleman. This was a CRT indication, heart failure, reduced ejection traction and left bundle branch block. Failed a CS lead implantation at the time of his original CRTD implant and received his bundle pacing with left bundle recruitment. EF normalized from 30 to 55%. Three years later, presents with follow-up and unfortunately the threshold on the his lead is now three volts at one millisecond and presented to us to discuss options. So we planned for extraction of the his lead and implantation of a new lead more distally along the conduction system with left bundle branch pacing. And again, as you see here, the left bundle branch area lead has already been implanted and honestly, really with simple manual traction, the his lead was easily explanted three years after implantation. Let's look at another case. This is a 68-year-old gentleman, complete heart block, dual chamber pacemaker with a lead placed at the his bundle. Device is now at ERI, presented for gen change discussion. Threshold at the time of this evaluation was now 3.5 volts. This was our first time seeing him and so we planned to extract the his lead and implant a new lead at the left bundle. Hopefully it's straightforward, right? But no, not every case, this highlights that you gotta go in prepared to use all the tools and every trick you've learned up your sleeve in every case and hope that the case is straightforward but be prepared for. So as we shoot our initial venogram, which we tend to do for most patients that we are upgrading or extracting a lead, you see that there is an area of an occlusion and you see that even despite that, we were able to pull on the 3830 lead and dislodge it from the region of the his bundle but now we have to figure out how to retain access and be able to implant a new lead going forward. You see a temporary pacing catheter as we're doing this. So let's talk about what do we do to prep this lead. It was a beautiful paper and I would recommend that you guys review this if you plan on doing luminous lead extractions. This is by Bruce Wilcoff from the Cleveland Clinic in campus and this really talks about using multiple tools and also breaks down what sort of a tensile strength you're able to achieve with different tools. So the Bulldog lead extender is our friend in these sorts of situations. So one option really is to cut the lead, use the Bulldog without the tube. Here's the tube taken out of the Bulldog lead extender and you insert the lead cable through the Bulldog lead extender. You tie one ties over this and that gives you this picture of a system that is now easily extractable and can fit through any of the extracting tools whether you use a laser or a mechanical tool like a tight rail. You can also actually take off the seal from the proximal pin and attach to it a strong suture like a fiber wire which is something that is very commonly used in the orthopedic space that might enhance the strength or the tensile strength and extraction ability even further. And so how do these play out? So here's just going through each of these steps but really as you look in this bottom chart here, this talks about standard prep versus modified prep which is using your Bulldog extender as well as a one tie and then combining that with snaring from the groin really gives you the highest average pounds of about 13.4 in this mechanical prep model. So really you have varied degrees of tensile strength that you could achieve depending on how adherent you think these leads may be, do you need to retain access versus not, all of those will eventually play into your decision. And so what we ended up doing in this case really was the same is we snared from the bottom, we grabbed a hold of the tip of the lead and then these are not images from the same patient but just a representation where you can now as you've snared and you're able to extract more from the top and then that gives you access into the vasculature to be able to implant a fresh lead going forward. So what does the data tell us? So his bundle pacing extraction experience, relatively small, 30 patients, this is by Dr. Vijay Raman in his group. Again but what I'm trying to highlight, indications for extraction about 10 patients with infections and the rest were not infection indications. About 22% of these patients had a lead that was implanted for over a year but all of these leads came out with manual traction alone without any damage to the conduction system. Another small series with 11 patients, again all of these leads average dwell time of 1.4 years, all leads came out with manual traction. What about extraction of leads from the left bundle area? This is a big topic of discussion and really something that we're all hoping to have more data going forward as these leads stay in for long periods of time but at this point in time, as you can see, most of these cases, these leads very easily just pull out of the septum without any residual VSDs in all the cases that have been reported. Longest leads that have been extracted in this region have been about four years or four to five years now and no residual VSDs or any challenges in that sense but I'll highlight a couple examples of things that are possible that can go wrong in this region as well. So here's an example of a helix that just continued to stretch out and got stuck into the septum and the rest of the lead was extracted. Here's another example of a lead where the lead needed to be extracted but you could see that there was damage between the tip and the ring electrode resulting in failure of this lead which is why it needed extraction. This is not a luminous lead though, so just to highlight that. So final slide here really talking about the overall experience of extracting leads from the conduction system. This is presented by Dr. Vijayaraman last year as a lead breaker. 224 leads in the his bundle region, 117 leads in the left bundle region and you see that average dwell time of 22 months. Manual traction worked about 87% of the time and mechanical and laser lead extraction was needed in about 13% of the cases. Most of that is because of lead-lead interactions and binding up in the subclavian and ominate region as opposed to within the his bundle or the left bundle area itself. If you break this down further, within the his bundle region, complete success was 99% and 90% for manual extractions with an average dwell time of 29 months and in the left bundle region, as expected, an average dwell time of only nine months. So in summary, the 3830 luminous lead extraction is relatively forgiving in both the his bundle and the deep septal regions, particularly with a short dwell time given its higher tensile strength. The risk of extraction of chronic luminous leads in the deep septal region in particular remains unknown. Unique challenges may emerge, particularly will the helix present a problem, more breaking of the helix and remnants of it within the septum maybe require newer techniques going forward. More data are needed on long-term extractability and caution is advised, particularly when it comes to extraction of active fixation stylet-driven leads. Thank you very much. Thank you very much and for our next speaker, we'll have Dr. Charles Henrickson from OHSU to present on how to approach large weed vegetations. Okay, thanks to the the committee and the chairs for this opportunity to come talk about large leach vegetations Okay, no relevant disclosures so large leach vegetations Obviously the concern is that these may shear off and embolize at time of lead extraction This is just kind of logical and the the somewhat arbitrary cutoff has been in the two to two and a half centimeter range Which I say previously we used as a cutoff to refer to surgery You know, and there was some data to support that this was a early paper looking at 38 patients nine of whom had lead vegetations over a centimeter and there was some evidence and in over half of them of some pulmonary embolism following extraction so around this time It was fairly standard to send everybody to To surgery with larger vegetations this paper kind of opened that up for me at least this was from Steve Kudalek with a hundred patients with bloodstream infection and vegetations on the CID Vegetation side varied a great deal, but the average size was 1.6 centimeters And in those hundred patients only two had evidence of pulmonary embolism and none were kind of life-threatening That kind of opened up. I would say the field a little bit to to taking out leads with larger vegetations and The definition of large vegetation is Fairly tricky, you know on most of the papers that describes the dimension in one Sorry that length in one dimension that You know Requires you to really think about this a little bit how many dimensions? What's the quality of it some wispy thing that you can kind of measure at three centimeters? Is probably not that important if something looks like a series of small marbles I'd be much more concerned So That's led to the aspiration and mechanical removal of vegetations This is similar to what's done for you know vegetations without the presence of a CID or for DVT's of Pulmonary emboli and that sort of thing the the advantages of going in and trying to debulk them is that it that it debulks the mass Decreases the infectious burden and decrease the risk of embolization of the material during extraction That's probably the main reason to to do it It's certainly a nice alternative to an open procedure and and is really important obviously for patients who are not surgical candidates So there are a variety of systems to do for this they all work on the same principle, which is a You can't see that which is a tube basically a vacuum of some kind with a Some sort of intake on the front end some mechanism for making suction and pulling out the vegetation along with some blood The angio vac has the greatest published experience The advantages of that is that it's a continuous suction on a pump The downsides are it requires Cardio Requires venous venous bypass with the perfusion team To set it up and systemic anticoagulation Both the alpha vac and the flow trevor are smaller systems with a hand thing to develop the suction The flow trevor has a way to return the blood And then lastly despite the way it appears here on this slide the penumbra is much smaller with a so potentially less useful for the larger vegetations that we're talking about and There isn't a way to return the blood in a straightforward way So there are supports from the various guideline documents to support use of these systems You know from the last lead extraction guidelines in general open extractions are considered when the patient has You know identifies a large lead mass, which they defined as a greater than 2.5 centimeters and there are various case reports discussing different ways of debulking the things which is a potential kind of a to be endorsement here and on other guidelines for in general without mentioning CIE DS aspiration of vegetations appears in the ESC guidelines and the AHA scientific statement on endocarditis associated with IV drug use And in the European heart rhythm guidelines for device associated endocarditis So the largest series along these lines was a Angiovac series that was looking at 101 patients at four large extraction centers and Large vegetations were defined as greater than 20 millimeters in any dimension or greater than 10 if there was also a PFO present These were all angiovac system Cases and they had great results. The mean lead age was 81 months 94% complete success in removing the vegetation and extraction success in essentially everyone with only rare complications And again, this was the angiovac system that that they used That required the venous venous bypass and anticoagulation so in our for our experience Chris wanted to talk about this early case. This was not a patient with a CIE D, but the pictures are impressive So I thought I'd show it anyways This is a 62 year old woman with metastatic cancer found to have a large thrombus associated with central venous catheter she has felt not to be a surgical candidate I think this is Reasonably obvious to most in the room that there's a mass in the atrium The pictures on the left A and C are a couple of views of the mass that goes from right atrium into the SVC and then on the right as after it's cleared out and you can see in D you can see the Flow tree for catheter, which is what we used in our on our patients This is the echo I Hope Yeah, so that's a view One view of the mass another view And it's you know, obviously there are a couple parts to it. There's the flow tree for catheter kind of chopping away at it You can see it's been largely debulked, but there's still some there Some there And So kept working on that and trying to get it all out And the last part was to break it up. There are these night and all discs to put in that kind of look like a watchman to break up where the Where where there's remaining mass Then To move on the second case that I want to talk about was a CID case I 59 year old man of prior cabbage heart block and stage renal disease in a by the ICD That was about five years old had persistent bacteremia large vegetation associated with the tricuspid valve and Here are the pictures you can see that large mass kind of associated with the tricuspid valve and the side of the septum and These pictures this is also with the flow trevor system here, you can see the mass flipping in and out of the valve and a couple different views and there's kind of stabilized by the Flow trevor catheter. I was able to get out just about all of the Just about all of it And Oops Sorry So that in lower panel there and D is what what was retrieved out of the out of the bin Which is a lot of a lot of mass to that vegetation Lastly Was another case in our hands is a 49 year old woman with end-stage renal disease and bad vasculopathy and a pacemaker this was only two years old and At the time and still we Take out two-year-old leads in the EP lab She had persistent staph aureus bacteremia good sized vegetation attached to the lead was felt not to be a surgical candidate we actually did the taking out the vegetation and the lead extraction in the IR suite for the comfort of our IR colleagues And with the two-year-old lead we felt that was safe. We did end up having to use the laser But everything went well So this was another list of the available systems and again Not to get too far into the weeds, but the the NGO vac is the one requiring the perfusion team and systemic anticoagulation flow trevor is what we used which has the advantage of multiple catheter sizes ability to return the blood But not needing the perfusion team and then the penumbra is the much smaller system So our current approach Luckily, these patients are rare enough that we will hopefully none of us get so comfortable that this becomes a routine thing to do but we work closely with the surgeon and with in our in our shop IR who And the surgeons may want to the mass debulked or the leads taken out Even if they are a surgical candidate and going for valve replacement sometimes But still open resection is the gold standard and that's what we stick with. Clearly. This is a multidisciplinary Approach to these patients and the setting depends on the age of leads Obviously it lead extractions are mainly done in the OR But if they if these are relatively new leads, which sometimes happens in these sick patients You can do them in other settings to To allow the aspiration to go more smoothly Thanks all So we'll move on to the questions I want to remind everyone if you have any questions Just do feel free to put it into the app Yes, hi Question for Dr. Engstrom regarding the we have extracted leads like this with debulking a mass as well the Cultures we got from the lead was negative The cup that's what we got I mean, I didn't have the culture myself, but two of them had negative cultures. The the masses were positive So that raises a couple of questions one is if you have experience in in culturing these these hardware or not and Two should we make a diagnosis sometimes with these tools? So instead of if you think about the process of Lead extraction you sometimes you get consults with ID and and all they can contribute is take the lead out. That's a contribution There may be just one positive culture with even with staff But that the patient clears the bacteria very quick there There's no repeated cultures to go by because they don't always take cultures after that And now you do a TE and you find some fiber in something that on the lead and you're saying Okay is the lead needs to be extracted or not? Now if you put risk and benefit, you can also take these things with alpha vac Nothing so with the angio back which you don't need to do the whole circulatory Bypass, but should we use that as a diagnostic tool not just as a treatment tool That is an excellent question Yeah That's a great question I you would one would assume that sometimes the Bacteria are better protected inside a Vegetation and so you could argue that that is a good way to take them out and get better material to culture Boy, I think for the more concerning bugs like staph aureus if you've had positive cultures We know it has to come out Do you always take a cup of one culture positive of staph you always remove the lead Depends on depends. So again, you come back to the same question. Yep Yeah, I don't I don't think I have a well-worked out answer to that I I would say that if Yeah I'd be I think that culturing the mass is a excellent idea that aids in this Boy, I think if the leads were really old and there was it felt like really high risk to take them out Then then I like that idea if if the leads aren't that old and you're having all this setup You're probably gonna take everything out. Anyways, we should probably also look and see again How many of the leads that we're taking actually positive cultures? So maybe that will support the thought process of taking these Material out like a biopsy. Yeah May I ask you you're referring to a patient that had positive blood cultures to begin with and then you didn't see anything Negative on the lead cultures were negative. Is that positive blood cultures on antibiotic? You don't always take the lead the day they come correct You get a treatment for a week or something like that And then you go you take the lead out and then now the cultures are negative on the lead but The reason why you took it out was because he had multiple blood cultures now There are many patients that have only one blood culture positive and now you're saying I don't think the leads needs to come out Necessarily and then you get people get a TE and then the T shows Something on the lead and then everybody's saying take it out. And now you're in a process of you You're the last station. You're the one that needs to make the decision And if you have those tools Then you have something in your arsenal to say take it out Don't take it out and it's not just always a neat To take these things out the two comments that I have on this one. I totally agree I think if you have a very high risk patient where you're like, okay, there's the risk of you know Mortality in this particular case is extremely high And there's a lot of back-and-forth debate then perhaps using that interim You know giving you more details or answers perhaps may help us guide where do we go next? That's one way to process it The the other interesting thing is and I don't know the answer to this on the top of my head but perhaps some of our panelists do What is the percentage of leads that we actually extract for true endocarditis or infection that are really positive do I? Would honestly say I have never really focused on that because the treatment doesn't change the leads out you give them six weeks of IV Antibiotics perhaps, you know having the leads be positive makes you feel like you did good for the patient But but I don't really know. What is the true incidence and if it really does have a clinical Meaningful impact in what you would do anyways, right? Maybe those leads are not all meant to be positive But you still should be taking the system out because it has implications and I don't know the answer There is no question There's no question But a lot of patients fall in that gray zone and we take those leads out because we can not necessarily because we have to and it because we forced to because of the our colleagues and everybody else so The thought processes data sometimes is not a bad thing and if the patient is stable and there is a mass and We learn how to use the end the alpha vac Not you don't have to do the angio back the alpha vac You might be able to do do that And if you improve on the technique of the alpha vac, you might be able also to guide it there and can Extract it. Although you could do it also with a snare and other things. There are other ways to do that Thank you very much for the interesting question Raises a lot of new questions and a lot of gray areas certainly we have no definite Guideline based answers to that but but before we end just want to answer this question or pose this question That was posed online that trials for TV devices excluded patients with leads Depending on the device the needs will be entrapped. Maybe not with a triclips So the the audience asked shouldn't we just extract all leads that are likely to be entrapped as part of any TR percutaneous treatment No Well, first of all patients with leads were not excluded from tricuspid valve studies certainly not all of them Sir some in some cases we don't know whether patients have leads But we know that a lot of patients with leads were part of protocol ized tricuspid transcatheter tricuspid valve replacement and repair and I think there are a lot of cases in which Patients who have trans valvular leads and who I would say are undergoing trance catheter tricuspid valve Intervention in whom gelling the lead is a very appropriate thing to do Just by nature of being eligible for transcatheter tricuspid valve intervention. These patients are frail Multiple medical comorbidities they tend to be older. They tend to be female Sort of all the all the things that make us worried about an extraction case So in no way what I advocate for extracting every lead across the valve before tricuspid valve intervention But I would absolutely advocate for thinking about every case Thinking about extraction in every case for a patient with the lead across the valve before intervention And this goes to what dr. McCorny was was saying about really engaging the patient in that conversation I think our patients can are capable of much more sophisticated Conversations than then we give them credit for in many cases and certainly when we're talking about extraction in other situations It often takes two or three conversations before we get to an answer and this is no different. This is perhaps even more complex So those are my thoughts. I don't know other people. Thank you very much So we're at the top of the hour We want to thank again our speakers for your sharing your expertise and thanks to the audience for your engagement Have a great evening

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