Welcome, everybody, to the Rhythm Theater. Really excited to see everybody here today, grab some lunch. We're going to have an hour to spend together and talk about some important topics in lead management. We have an all-star cast up here, and I'm really looking forward to hearing what they have to say and looking forward to having a discussion, hopefully, at the end of these four talks. Each talk is a little bit different, but we hope that they are connected in the sense that lead management takes on many facets. And so we're going to present some of those facets today, and you'll understand that there's a thread running through them that all relate to sort of a comprehensive approach to lead management. So I'm going to kick things off, but here's our agenda. I'm going to start the session by talking about the issue of delayed extraction in an infection. Then Dr. Metzl is going to talk to us about lead extraction for patients with devices across tricuspid valve. Then we're going to hear from Dr. Vadarat to tell us about extraction of leads with low tensile strength. I'm going to share his deep and extensive knowledge about lead design with us to help us understand tensile strength. And Ro Metta, having been just recently released from the NBA, as he should have been, was not selected for the draft. He is going to talk to us about extraction of previously abandoned leads. And then hopefully we'll have some time for questions at the end. So please submit your questions through the app, and I will do my best to curate them and get them answered for you. Stand? Maybe I'll stand. Okay. Delayed extraction in an infected patient. Just hearing the title, I'm already a little bit nervous for whoever this patient is. Here are my disclosures. And I guess I should say we're supposed to all introduce ourselves. I'm Emily Zeitler. I'm an electrophysiologist at Dartmouth in New Hampshire, and I direct our lead management program there, and I'm really excited to be at HRS with all of you. I'm going to share with you a case that still brings me nightmares. This is Mr. B. He's a 63-year-old man, has ischemic cardiomyopathy, and had a CRTD placed in 2008. He was a super responder, despite the fact of not really having characteristics that might predict that he would be, but he was a super responder, and a lot of other coexistent medical conditions, including advanced renal disease, insulin-dependent diabetes. He had class three, class four obesity. He had severe peripheral arterial disease with a prior BKA, prior extensive tobacco use, although he was no longer smoking. He had a history of a radical thymectomy. I don't know that I've encountered other patients with this treatment in recent past, but in case you haven't either, this means that he'd had a sternotomy for removal of his thymus, which is, of course, relevant for our discussion of lead extraction. He had a history of AFib, was on amiodarone and Xarelto. Here are his hardware characteristics. He had an Abbott CRTD, was implanted in 2022. His oldest lead was his tachy lead from 2008. This was a Riata 1592. This is part of the family of leads that were recalled by Abbott and FDA in the context of inside-out abrasion and electrical failure in the early 2010, 2011. He had a right atrial lead from 2010, and he also had a subcutaneous coil. It was unclear to me why. In retrospect, he likely failed DFT at some point. He was a very large guy, and so a subcutaneous coil was added to his system to lower his defibrillation threshold. Oh, and of course, I have this red arrow on the RV lead. Looking at this hardware, this is the lead that would all make us pause a little bit. This might be a challenging extraction if we need to extract this system. In March of 24, he developed vague symptoms of malaise, fever, cough. He developed, actually, hypotension and distributive shock, was diagnosed with metapneumovirus. His blood cultures were negative, though. He recovered. He was discharged home, but a month later was back with progressive symptoms. At this point, his blood cultures were positive for staph, staph aureus. I thought maybe the source was a left-leg cellulitis. He didn't have a right leg, but his cultures cleared on day three. Somebody was thinking about his device because they did a full-body PET CT looking for FDG uptake in the area of the device pocket, perhaps. That was negative. He had a TEE, actually, which showed no vegetations, and so the decision was made to leave the device in situ and to treat with antibiotics only. He completed five of six weeks of his antibiotic course, but then really, really, really wanted to get on the road for his planned road trip vacation up to Upper New England. He had his PIC removed. He transitioned to oral antibiotics and then basically immediately became sick again and went to a local ER in Upper New England. He rapidly developed shock, requiring vasopressors, intubation. Blood cultures were positive for staph aureus once again, and he was transferred to my institution for consideration of advanced lead management. I'm showing you his chess film. It's a terrible film, but we didn't have any good films. He's a really, really big guy. He was really, really sick, and I'm counting for you the hardware here. Number one is his tachy lead. Number two is his coronary sinus lead, which you really can't see very well and wasn't much better under fluoro. Number three was his right atrial lead. Number four was a subcutaneous coil. I've labeled the can, and he also had a pulmonary artery pressure sensor in the circle. So I'm going to pause the case there and just remind everybody about why this probably happened. It's really no surprise. We know that with staph aureus in particular, that treating with antibiotics alone leads to a very high rate of relapse, somewhere in the neighborhood of north of 50%. There are a variety of estimates for how frequent this is, but it is very frequent. And so without device removal, we should anticipate recurrence of staph infection. Staph bacteremia, it's really bad, and there's no getting around it. And I'm showing you this updated algorithm I really like from SRCTN24, which really highlights the fact that in the setting of staph aureus bacteremia, a TEE can be really valuable for planning your treatment duration and perhaps looking for surgical disease, for example, but it's not going to change the fact that the device needs to come out. And you can follow along the left side of this algorithm. If you have staph aureus or coag-negative staph bacteremia, by all means, do the echo, but know that you're headed towards extraction, that in patients who are eligible for extraction, this is the only way to definitively clear the infection. But I can understand, and I think we all can, why this patient maybe didn't go directly to the extraction lab. And I never did have the chance to speak with his electrophysiologist that cared for him at his local institution, but clearly they were thinking about this, and they were thinking about needing to take the device out, but were concerned perhaps about that RIATA lead, knowing that that's a difficult and potentially dangerous lead to extract, trying to balance risks and benefits. And they may have read this paper from 2021, where we looked at the rate of complications from the extraction of RIATA and Fidelis. Part of the rules with the NCDR is that you can't look at one lead in particular. So we combined RIATA and Fidelis, both recalled around the same time, to look at the rate of complication from elective extraction of these leads. Now we know that complications are higher in patients who are infected, but when these leads were extracted in an elective setting, the rate of complication was pretty high. So in the NCDR, the rate of any complication, death or any procedure-related complication prior to discharge was over 10%. And that's a high number, and when I saw this, I thought, well, my complications aren't that high, but these are what we see from registry data. So it's reasonable to think, this RIATA lead's infected, I want to do everything I can to avoid taking it out, but here we are, and Mr. B has recurrent infection. So the patient was transferred to my institution, where we had a difficult family meeting, talking about this extraction procedure, and we recommended that the system be removed as the likely source of persistent bacteremia. We prepped our leads in our routine manner. We did not cut the terminal pin of the right atrial lead, given the lead model. The RV lead, we did not attempt helix retraction, which is a typical component of our lead prep for RV lead extraction. Given the lead design, we were concerned about fracturing that lead. We did fluoro the RV lead prior to extraction to look for areas of cable externalization, which might have changed our approach. We didn't see any cable externalization, and we were able to completely remove the RV lead, thankfully. We all took a big, deep breath after that. And then the CS lead was actually the one that gave us the most trouble, mostly because of the patient's body habitus. We had so much trouble seeing the lead. And I'm showing you this picture not because I'm proud of it, because there's a lot of different tools in there. There's a laser, there's a bioptome, and there's a snare. We actually did ultimately get the lead out with a snare, but it wasn't pretty, and it took a lot of tools and a lot, a lot of fluoro time. And then the subcutaneous coil came out with simple traction. The RV lead tip grew staph aureus. Then he was able to get an MRI, which showed a psoas abscess. He had lumbar spine discitis, had drainage of that. It was initially doing better, but then decompensated, found it had C. diff, progressively decompensated. The patient's family transitioned to comfort care, and the patient died later that summer. So for this patient, there were serious consequences of late extraction. I mean, who's to say what would have happened if he'd been extracted with the initial presentation for staph bacteremia, but it's hard to argue that it would have been any worse than what happened later that summer. We know that in a Medicare population, our patient was 63, but he was awfully close. In a Medicare population, infection occurs in about 1% of patients, and these are excellent data published by Dr. Percorti and his colleagues at Duke, looking at Medicare claims data, where they saw that the rate of infection was about 1% at about four years, but most Medicare beneficiaries do not undergo extraction. So only about one in five at 30 days, and that at one year, mortality following no extraction versus extraction within seven days was pretty substantial. It's a difference in mortality of 38% versus 28%, and by my calculation, that's a number needed to treat of 10, which is a pretty good number needed to treat. So from this case, my takeaways are that extraction delays are strongly associated with poor outcomes, including mortality. Sometimes we can't save these patients, but if we delay extraction, we're not making things any easier. Staph bacteremia is not a forgiving disease, and available tools cannot reliably identify low-risk infected patients, and I think what my colleague at the patient's local institution was trying to do was really appropriate, was trying to risk stratify this patient, trying to understand, can I get away with not extracting this patient, because it's going to be a tough case, and indeed it was, but the tools we have simply can't identify who should and should not be extracted in the setting of staph bacteremia. And that because of this patient's specific hardware, it was an intimidating extraction case, understandably, but we need protocols and algorithms in place to help connect our community so that when one institution is not capable of providing safe, comprehensive lead management for every patient, that we have communication and algorithms in place to help get those patients the care they need. Thank you, and I'll pass it along to Dr. Metzl. We're going to have questions at the end, or you can submit them through the app, and I'll be happy to answer them. Thank you. Nice job. Nice job. Yeah, nice job, Dr. Zeitler. Thank you. I'm Mark Metzl, and I'm from Endeavor Health. Thank you to Phillips. I was thinking about being from Chicago, and I'm Endeavoring today to convince you to try to keep leads out of jail, and so maybe they picked me because of our politicians in Illinois. And the topic for today is very pertinent and important because this issue is happening with or without us, and so I'm going to try to convince you to get involved with your structural colleagues, if you're not already, because these devices are now on the market and more are coming. Last year, we had TriClip and Evoke valves, the valve replacement approved, and if we're not dealing with these patients up front, we're going to be dealing with them after our leads are jailed. And I think the real problem is that there's not a lot of evidence in this space yet, and there's not a lot of guidance, but the good news is that it is coming or it's happening today and tomorrow, and we do have some guidance from just a few weeks ago. I do want to mention kind of here at the beginning, if you have a choice between a clip and a valve replacement, clips don't jail leads, and there is some success with clips without damaging leads, and so a little plug for clips. What evidence did we have or do we have? The best evidence that we've had is from a valve-in-valve database, and so this is patients that have a ring and are getting a TAVR valve placed in that location with leads in place, and in follow-up, 11% of patients in about a year's time developed lead failure. And another concern is pocket infection. We had a patient we wrote up with a pocket infection, and now how are we going to get that lead out? We're never going to clear that infection. So there is already some evidence that jailing leads, especially patients that are dependent, is a bad thing. This slide, I wish I could have updated for you. This data was actually published yesterday online in HeartRhythm. Thank you to Mike Lloyd for sharing it early. The Emory experience with jailing leads with evoke valves, three out of four patients had lead failure, so small numbers. I think in their series, they ended up with five that they published online yesterday, so growing evidence. This was actually presented an hour ago, so thanks to Graham Pay and the group over at Northwestern for presenting and sharing this data with me and you guys. They were not involved early on with the heart team, and patients go ahead and went and had evoke valves implanted, and out of 42 patients with entrapped RV leads, three of them had lead complications. And interestingly, over time, following those other 39 patients, a good number of them actually had electrical abnormalities, including RV threshold increase, which you'll see in the blue box on the end. And so this is something that we have to be very mindful of, especially in our dependent patients. On the other side, we're going to see a poster tomorrow from Enrico Ferro and the group at BID, and to thank him for sharing this data with us early on extraction. So what if you extract these patients beforehand or at the time of their tricuspid intervention? It actually goes really well. This is Medicare data over the last couple of years, and so a plug for his presentation tomorrow at 2.30. We have alternatives. Leads don't have to cross the valve, and so if you do an extraction for these patients, you have to be thinking of what options do we have for re-implantation. And we now have management guidance. So about three weeks ago at AERA, the HRS, AERA, and others published some guidance, and they were much, much more aggressive than the evidence that they had showed about not jailing leads. And so red flag for pacemaker dependency, red flag for ICD with previous therapy, because if you lose that lead, it's a big deal if you have dysfunction or failure. Yellow flags for multiple leads, history of infection or high risk for infection, and to actually look at the lead slack or tension because of the risk of failing. And if I could, my laser pointer is not big enough, but heart team discussion is really the number one thing here. We have to be involved in this, and so early on, they recommend assessing the mechanism. Is this lead-related? Is this lead-associated? And what's the device indication? But heart team discussion includes you. It includes us. And that's really important and is stressed in this management guidance. Well, what are the barriers to better care? Number one is communication. The obstacles that I could identify, some of these are ours. We're busy. We're too busy to push the needle. I'm doing afib oblation all day. I don't have time for the meeting. I don't want to go to a meeting where they're talking about TAVRs 90% of the time. So there's barriers on our side. And then also, is this my problem? Maybe I don't want to be involved. What I want to convince you is that it is our problem. If it's not our problem today, it will be weeks from now. So it's important for us. And then there's a major misperception about the risk of extraction versus the risk of jailing. And that is true both with our structural colleagues and also our general colleagues and imagers. And so it's very important for us to be educating our colleagues. Of course, there's administrative reasons why there are obstacles. There's system-based obstacles. But this is worth our effort. And so it's very important for us to get involved. I think that the title of this whole thing is cases. So I do want to illustrate a quick case with you guys. This is a 76-year-old woman who had a dual-chamber pacemaker. And the echo reveals severe TR. And it's believed by our imagers that it is pacemaker-related and not associated, that the pacemaker lead is the problem. And we get our heart team together. And I go, I'm happy to take it out. Even if it doesn't get better, at least it won't be in your way for whatever you need to do. The imager is convinced that it's the lead. And the structural cardiologist says, well, maybe we should just clip it in place. And then it realized that the imaging wasn't really good enough to clip. And so he wanted it removed as well. So we ended up removing the we did an extraction. It went well. And we put in a dual-chamber of air, an alternate strategy for patients with severe TR and the thought that these wouldn't get in the way. But what happened is that our imager was wrong. There was a large coaptation gap. It was the annulus, not the lead. The annulus had dilated. And so it precluded clip. And this patient actually got an evoked valve and did very well. And symptoms improved. And it's pretty remarkable to see her with her evoked valve and dual-chamber leadless pacemaker. And now her symptoms are so much better. So how are we doing this? What's our practical approach to this? Not very different from the HRS and ARO recommendations. We assess the valve. We try to see, is this lead-related? Is it not? What's the mechanism of this? And most importantly, we actually get together and talk about this. Whether that be in person or virtual, you got to be involved. So here's my call to action. What can I do? Education, make friends, and most importantly, take responsibility. Like these patients may not get referred to us for their tricuspid intervention, but it is our responsibility. And if it's not going to be today, it will be a few weeks from now or months from now. So grow awareness and discuss the safety and make friends. So thanks very much. I'd like to introduce, I guess, Dr. Pierce-Vaderot to talk to us about extraction of special leads. Thank you. It's great to be here. So the, nope, that's not the one. Here are my disclosures. My, well first, my personal background is a recent, I retired three years ago from clinical practice having a large practice that primarily was focused on lead extraction. I've always been involved in research. I live in the Twin Cities, Medtronic, Boston, Abbott, et cetera. And so I've been able to involve, be involved with the lead engineers and I want to show you some bench testing that hopefully will add to your skill set for safe and successful extraction. So some of the background. The bench testing that we did grew out of a lead extraction course that we had in Minnesota. We actually had the lead engineers teach, the people who designed and built the leads, teach the construction portion. And then we had the clinical individuals doing extraction. And we really talked about some of the issues, how to take this crowd and have safe and successful extractions. With, we have, because there's different types of lead construction, the average U.S. extractor, this is Phillips data, does 10 to 12 cases a year. And there's different types of lead prep methods that are really taught by mentor to student. And I threw in there some other Phillips data and in extraction, the average traction is 48 pounds. So I'm going to leave you with those thoughts and first talk about lead construction. There's four basic types of lead construction. We're going to talk about coaxial, one coil inside the other, and coradial, where the anode and cathode are wrapped together. Each of those leads, and I talked about four basic constructions, the construction varies between companies of those four basic and also within the company depending on the model number. So there's multiple variables. And think about as a low volume extractor may be facing a lead that has never seen before, doesn't know the construction. Each of those leads has a certain tensile strength. Think of that as how strong is the rail to advance this powered sheath on. I'm going to take you to this slide. This is the index case that drove us starting bench testing. This, Boston Scientific provided this to me a year ago. This is 20 year data on the fine line tube. The survival rate, 97%. Some of the best, if not the best today. But, extraction is hellish. I see some heads going up and down. This is one of my cases. I'm down to a single filer here. You can see here, not a good rail. There's the SVC wall, a point of terrorism. So again, think of all these constructs, low volume and multiple lead constructions, mentor taught. We attempted to identify it and it was the lead engineers that first said, let's use bench testing. All the companies have the same equipment. We've been doing this for 67 years to improve lead survival and reliability. Let's create a bench test model for extraction and really try to determine what's the strongest rail. And that's the basis. Now, we've done five families of leads across two companies. In fact, the companies like me working at the different companies because all the boats float higher. We're going to talk about some Boston Scientific work, two of our three publications so far. We're currently starting a fourth. And what's the bench testing methodology at Boston? It's based on a silicone heart model from CT scans. And then you can see the pulley system there that imitates basically from a left subclavian implant. And right there is an atrial tip scar only. And we looked at these variables, lead terminal prep, cut or remove, locking stylets and all, locking style, different types, they're all equal. Lead binding mechanisms and lead attachment points or scar, the results. So, abbreviated in this talk, but here on the y-axis, this is when the lead's pulled apart and our three family of leads. So, single filer co-radial, polyurethane silicone, single filer co-axial, then three filer. So, first of all, three filers are stronger than one. Is co-axial stronger than co-radial, co-radial? No, they're equal. It's the number of filers plus other factors such as weld joints and crimps. Thirdly, and the most important point, is leads, locking stylets and all, but terminal pin versus preserved, leaving the terminal pin on improved rail strength. And the thought process here is it encompasses, first of all, you have manufacturing consistency, which is 99.9 something, and the load forces are distributed across the lead, entirely across the lead, including the insulation. Now, this is statistically important when the insulation is polyurethane. Silicone tears very easily. It was stronger, but not statistical. I want to show you some interesting, too, locking stylet responses. So, this is our model, tip-only scar, locking stylet. We're applying traction gradually up to two pounds, tip-only. Lead looks a little stretched, but here's the fluoroscopic image. You can see the locking stylet is all the way back here. It's locked back there. Has it slipped? No. All the loading forces are now distributed past the locking stylet. And here's a nice animation. I'm going to show you here how the ETFE insulation pulls apart here, and then the flexible neck breaks that uncoils and breaks. So, remember, the average extractor pulls at four to eight pounds. This is an Ingevity, a classic Ingevity. And so, we peel away the color. Now, watch this. The ETF pulls away. Now, the flexible neck breaks. By the way, this has a locking stylet. The coil uncoils and then straightens out and then breaks. So, all the loading forces are distributed distally. The other thing I've told you, by keeping the lead intact, you incorporate all portions of that lead to bear the loading forces. Now, let's attach SCAR to it. SCAR also will help with the loading forces. So, in this animation here, we'll take an Ingevity lead. You're lasering up to it. Remember, these broke at four pounds. The operator's pulling hard, can pull all the way up to eight because the loading forces are distributed in the SCAR. Once you're through the SCAR, they go downstream to the next SCAR or to the lead tip and actually to the lead tip here. The lead's starting to come apart. What about snaring? You can improve rail strength dramatically by snaring a locking stylet. Okay? So, this is our baseline here on this Fineline II. I'm going to show you this here. They fall apart under five pounds. Add the SCAR because it adds to distributing the loading forces. Now, snare the locking stylet north of twenty pounds. You shouldn't be pulling that hard anyway. But, you have to do this the proper way. You need a needleized snare. You have to snare a locking stylet after it's locked and then you buckle it into the, I apologize, you buckle it into the inner sheath and actually on high resolution fluoroscopy and I wish I could show you, you see the nitinol wires coming down actually separating the co-radial coils on this Fineline, it's a co-radial, and grabbing the locking stylet. So, does this work in every case? No, it does work. You always have the best rail, but it varies depending on the structure. On the right, this is an Ingevity PF single filer coaxial. The inner coil is lined with ETFE, actually melded onto it so when the snare comes down, it can't quite grab the locking stylet, but it still pinches it, you still get a better rail. And this is a nice summary slide on the Y axis, where the lead broke, you know, the amount of force. On the X, you can see our two families of lead, two families of co-radial leads Fineline, single filer. The Ingevity classic single filer and three filers, three filers stronger than two. Scar, heavy scar is stronger than medium scar. Snaring is always the best. Now, do you always need to snare? Absolutely not. Absolutely not, I want to stress that. And here's the statement I want to give you. When the forces of extraction are greater than the tensile strength of the lead, such as these single or dual filer leads, the Fineline Ingevity, then consider snaring. Do you need it on the Ingevity classic, it's eight pounds north? No. So in conclusion, summary, preserving the terminal pin allows all lead components to contribute to rail strength by sharing the loading forces. Locking stylets engage a centimeter and a half back, resulting in the weakest region between the anode and the cathode. Adherent lead scar contributes to rail strength until you laser through that. And consider a thermal snare when the forces of extraction are greater than the tensile strength of the lead. And then, just recommendations, I'm not going to spend a lot of time on this, except to say one thing. Lead extraction is 90% prep. Know your lead construction before you walk into the procedure. Okay, thank you. All right, as we heard earlier, my career in the NBA didn't work out, so we're going to talk about lead extraction. So we're going to talk a lot about something that we're very passionate about in North Carolina. I'm at Sanger Hart Investor in Charlotte, North Carolina. And when I initially got there in 2008, I had inherited a program that really didn't believe strongly in lead extraction, so we encountered a tremendous number of abandoned leads. These are just disclaimers. So anytime we talk about procedural work, there are three main things we think about, safety, efficacy, and efficiency. And I don't know how many of you went to the plenary session earlier today, but Bob Califf had talked about our procedures are really going well, but our patients aren't doing so well. And so we're going to talk about this through the lens of the life of the patient. And what I mean by that is when we encounter abandoned leads, we think about the immediate procedure, but we don't think about the life of the patient. So I think it's important that we consider these things in the context of how we provide patient care. So what are the key risks with lead extraction? We all know this because we're all interested in this component because you're here at this session. So vascular injury, right, the thing, the catastrophic thing we always worry about, SVC tears, vessel damage, cardiac perforation, tamponade risk, the potential need for a sternotomy, infection potential from abandoned leads, right, and lead fractures and embolization. So the catastrophic things that can happen during the course of a case, but we also have to think about the frequency with which those things happen. So from a safety perspective, if you look at patients that are extracted with existing abandoned leads, we're actually making the safety of the procedure worse. We have a 15X increased risk of infection with multiple capped leads. And by the time of the third procedure, we're increasing that to almost 24%. 14% increased risk of venous occlusion with abandoned leads. So again, as we are in the era of potentially upgrading devices, looking for alternatives, potentially not using vascular access up, we're contributing to the problem. And as you get more and more leads, remember, we contribute to the concept of central occlusion. And these are very, very subtle symptoms in your patients when you talk about SVC occlusion. From an efficacy standpoint, a 7% absolute reduction in clinical sex with the presence of abandoned leads. A very, very hot topic, as we talked about today, an increased risk of tricuspid valve binding and perivalveal malfunction. Our structuralists are already busy with tricuspid valve intervention. They don't need more business. And an increased need for femoral conversion, which really kind of, it really prolongs the procedure and makes it a much more difficult procedure in general. And then when we look at the efficiencies as well, we're in an era of very, very limited resources. So we're all fighting for operating room time. We're fighting for surgical backup time. We're actually increasing our procedural times by an average of almost an hour. Increasing fluoroscopy. So when we look at our existing clinician power over time, we're potentially hurting our clinicians with the amount of fluoroscopic exposure. And then again, that increased risk of femoral conversion. It translates into an increased need for advanced tools, multiple sheaths, cost of procedures, longer procedural times, and an elevated mortality in complex cases. So one of the things we're going to talk about is a case to make the case. This is a patient who had actually sort of traveled through the state of North Carolina, receiving their care from multiple centers over time. This is a 74-year-old guy. And prior to the era of ablation, he had had AFib, had a dual chamber pacemaker placed in 1994. Ultimately ended up with an AV node ablation. So now he's pacemaker dependent. In 2004, he presented with pacing-induced cardiomyopathy and decompensated heart failure. After he had up titration of medical therapy and guideline directed care, there was the recognition he needed an upgrade. So initially, they did a venogram on the left where his existing leads were and found it was occluded. So they attempted actually a CRT device from the right. So again, losing venous access bilaterally now at this point. And they weren't able to get the LV lead in place, as oftentimes we'll encounter. It's a much more difficult implant in that situation. So in 2009, he underwent a battery change due to URI. And two weeks afterwards, he started developing fevers, chills, warmth. So we heard this earlier. Was treated with oral antibiotics, represented with local symptoms, and was counseled on options. So he was actually quoted a 5% mortality rate and a 15% major adverse event rate. I can tell you this is profoundly wrong in terms of the numbers he was quoted. And so the patient, thinking through that, said, I'm just going to go without lifelong antibiotic therapy. It seems like a better choice. Well, six months later, the disease progressed. He ended up with bacteremia. So now he really didn't have much of a choice. He still certainly could opt for palliative care with antibiotic therapy. But grew gram-positives. And so we're really obligated to remove his system. And so the other thing is, prior to reimplantation, you really need to have his blood sterilized. And he's dependent. So we'll show you just a few. So this is his chest x-ray. Unfortunately, it's not a great picture. But it'll highlight that you can see the abandoned leads on the left and his existing infected system on the right. So this was in the age where we were doing things with C-arms. And so this is an occluded left-sided vein. And one of the reasons that we knew that, so he had a class 1 indication. He agreed to system removal. And we had to think through how we were going to provide him pacing, and in this case, CRTD. So this is an interesting piece, because it'll show you collaterals in three different forms. So on the exam, I always tell our teams, look for this. Because on the physical exam, you can tell whether the patient's occluded. So you can see on CT scan, we're pointing out the collaterals. On physical exam, you can see the collateralization. And then you can see that on venography, too. A lot of abdominal collaterals that form, because he had extensive occlusion. So now we're bilaterally occluded. We're dependent. And he has to have his system removed and bilateral leads. So the standard option would be extraction with an epicardial placement. The patient didn't really want that. And he was deemed to be a pretty high operative risk because of his bacteremia. So we thought, in more of a novel way, because we were forced to do so because of the abandoned leads, that we would take the entire system out and place a temporary pacing wire, but also guide wire retention from the left-sided pocket, which was clean at the time. And so this is basically what we did. We'd taken out the right-sided system. These are the retained guide wires. We coiled them and sutured them in place and closed the pocket, put them on IV antibiotics and IV heparin in that situation, and had a temporary wire coming from below. We'd use the infected device and actually plugged it into the active fixed lead. So that's just an intraoperative picture. These are the leads we removed. And then about a week later, he came back once the blood was sterilized and got his CRTD system that he should have had in the first place. Now, we went through a lot to get this done without him having to undergo an epicardial system. And basically, his care was predetermined at the time where someone told him he was infected and he shouldn't have his system removed, and also prior to that when he had leads that were retained and abandoned. So you can see the consequences over the lifetime of this patient. And certainly, this could have turned out much worse for him. I think we got lucky in this situation. Now, he's normalized his LV function. He's back to Neurocardial Association Class 1. He had a really good outcome from this, but a lot of hard work went into this. So the biggest things that we think about, so the call to action, abandoning a lead can decrease efficacy, safety, and efficiency. So think about the concepts that we talked about during those things. And early management of these leads, recognition of vascular occlusion on exam, risk stratification, taking into account all these features, we need to start thinking again from a lead management perspective and a patient management perspective. So while we may encounter early risk, we really have to weigh that against the lifetime risk of the patient. And that's the thing I think a lot of things don't come into our minds when we think about these patients. All right? Emily? That was great. That was great from all of our speakers, I think. And I just want to comment that we all ran on time. So well done. We have some questions here from the app. I encourage you to submit your questions that way. And so I'll just ask these. So one person asked, I think this question is probably for Dr. Vadarat, does shaving the O-rings on the pins to fit in the sheath well alter the tensile strength of the device? Thank you for the question. I should have mentioned that. No, it does not. Those seals are silicone, and they're easily shaved off. You just take your scalpel and lay it flat and just kind of rotate the lead. And the primary strength on the external portion of these leads is actually the polyurethane. But the O-ring and even a grip sleeve, which are on some leads, are overlays, and you can take those off easily. Thank you for that question. Yeah, I think that's a good question. I think it's a nice trick to be able to downsize your tools by removing some of that excess. I wish I had mentioned it. Well, you have the chance. Here we go. Somebody asked, I think this probably pertains to the quick video I showed of removing that CS lead and that complex riata extraction, asked what snare did I choose. Probably better to say which snares did I not choose. I showed you the very end of a very long procedure. We used a lot of different snares. We initially attempted to snare, just like Dr. Vadarot mentioned, we had two ends of the lead were closed, and so we used a needle's eye snare. The lead then broke, so we had only one end of the lead secured. And then we tried a lot of things. Ultimately, we're able to get a gooseneck snare over the free end of the lead. I believe it was a 10 millimeter, and pull it out that way. Dr. Mehta, why not use the temporary pacing lead to preserve access? I think you came from the groin, though, you said. Great question. Great clarification. I should have mentioned this. So the right-sided device, there was an active pocket infection that had progressed a bacteremic option. So certainly, you could do that from the left side. It would potentially externalize it. I think there's slightly higher risk of infection in that setting, so we chose to just kind of temporize it in case we needed to switch it out. We needed a longer duration of antibiotic therapy, longer duration of heparinization. So it just gave us more flexibility from the groin. We have an attendee comment that you should not cut any leads, irrespective of the lead type. And I think that's an interesting comment. And certainly, it's one approach. I know, personally, I'm still cutting some of my leads, depending on lead model and case and patient characteristics. And I wonder, maybe, Dr. Metzl, tell us when you might decide to cut a lead and why. I think, actually, Dr. Vadarach is definitely the right person for this. But personally, I no longer cut any pacing leads for these reasons. I will cut defibrillator leads, especially the Medtronic ones. And I think that it is helpful to cut defibrillator leads to get control of the coils. So I always tie off the coils. I think that that is extremely valuable. But I don't cut pacing leads anymore. Dr. Vadarach? Yes. I love history and the history of medicine. I mean, how is it that we started cutting off the ends of leads? And so, actually, we researched this and looked at this and spoke to some of the mentors that were leaders in the past. And the first leads, the early pacing leads, the proximal end of the lead was 15-16 French. I mean, impossible to get any kind of sheath over. In those days, it was metal dilated and polypropylene. In fact, the early bipolar leads had separate poles for the negative and positive. So that's how I think this all started, just a little historically. At this point, I believe, and the data is showing, and there's some other people across the world that are starting to do bench testing, that if you can preserve the proximal end of the lead, again, I want to talk about manufacturing consistency. That consistency is so strong as opposed to, I mean, we're humans. We make mistakes. We can't make it as good, okay? And then, secondly, you're incorporating all features of the lead. What is the limiting factor? It is the proximal end of the lead fitting. Do you want to, in a now DF4 ICD lead place, and let's say some of the new ones that are 6 French down to 4.7 French, do you want to have that mismatch on the ID? So for me, it's really how comfortable are you with the size of your powered sheath? So basically, no pacing leads, and some people even starting to shave down ICD leads. We're starting to get a project on that going. Oh, interesting. We'll look forward to those data next year. Okay. We have a question, again, about lead prep. So an attendee asks us to comment on techniques for securing tough leads at the pocket. So maybe we can just go down the line and share your lead prep at the pocket with suture or any other tools that you use at the pocket. Yeah, no, absolutely. I think one comment I'd make is I think it depends in terms of prepping the lead and cutting the lead. It also depends on what you're encountering. So for, like, Riatas, especially, as you had presented, that kind of insulation integrity, high-voltage extrusion, I think getting individual control of those components definitely is helpful. You know, one of the things that I think has been really helpful to us is we started using a suture called fiber wire, and I think probably most everybody's using that. The tensile strength of that is just really incredible. It helps us a lot with insulation control and kind of multi-component control. So that's a big one that I would suggest in terms of incorporating into your practice. I'm not sure I understand the question again. So Dr. Mehta did a nice job reading my mind because I didn't ask a very good question. But the question was about what kinds of materials you use to secure the lead at the pocket. So suture material or knotting or, yeah. I want to tell you how that came, again, historically. Please. No fiber wire. We started with Ricky Green out here, okay, that she was the first person to start using that. She learned from her orthopedic colleagues who were using it to sew ligaments together, and then she started broadcasting and telling us at the lead extraction conferences and it spread. So I highly recommend that. And there's also the knot you choose. We can talk about that separately, but there's some nice, more secure knots that I think are better than others. But I don't think we have time to go through all that right now. Okay. You know what, Dr. Mehta, I'm going to take, I think that was a pretty complete answer, so I'm going to ask you a different one. I'd like, you know, one of the attendees asked about collaboration with surgeons, which is always a hot topic when we're talking about extraction. We heard from Dr. Mehta about the, you know, resource limitations, and surgical availability is certainly one of them along with anesthesia and any number of other things. But in this new era of tricuspid valve explosion, can you talk about, you know, you had a pretty mature algorithm that you shared with us about how you approach these cases. Can you talk about how, if and how, your collaboration with surgeons has changed in that context, or maybe just share with us how you work with surgeons in general? It's very open. Thanks. Please. Thank you. You know, to take a note here from Pierce, you know, the history of the heart team was really, didn't include us, and it was really about these complex PCIs. And then it was, you know, do we do bypass surgery or do we stent? And then valves came and ICs and structural cardiologists included the imagers. And now then we have heart surgeons and imagers and ICs getting together. And now we need to be part of this too. It is like fantasy to ignore this. So, you know, EP's got to be part of the heart team, whether that be in person or virtual. I think it is really important to talk about, you know, the relationship with surgeons and surgical backup. The best advice I give people is to be invaluable to them just like they're invaluable to you. And you need allies and friends. And there's this concept that our heart surgical colleagues don't need us. And that's, of course, very false. They need you and you need them, and you build that relationship and make friends. And it just works together. It shouldn't be a conflict. It should go well. Yes, in the best case scenario, absolutely. I know, Dr. Mehta, do you, I don't know what the truck husband program is like at your institution. Do you want to talk a little bit about how that relationship with surgeons may or may not be changing in that context? Yeah, we're pretty blessed. We've got a very collegial relationship with our surgeons. And it's dated back since I really have been there. They've actually taken an active interest in extraction from the perspective of tool development and actually innovation as well. So I think that's sort of helped the conversations. You know, one of the things that we really looked at is if you look at the tricuspid valve patient population, there's a hefty, hefty mortality to these patients. And so I think one of the things we tend to look at very early is what's the anticipated two-year mortality in these patients. And if it's astronomical, oftentimes let the patient expediently get done and we'll deal with the leads later. Because recognizing that there's a very good chance they may not make it to that point and it's a palliative procedure. But in general, it's a very, very good discussion. It tends to precede our visits with the patient and anticipated talks about extraction. And then within clinical investigation, oftentimes what we found is that we were talking to patients about extraction and they ended up going to intervention. So one of the learning points for us was really getting some sort of almost a summary on the patient to determine their candidacy for a tricuspid valve intervention, whether it's clinically indicated, whether it was clinical investigation related, what the anticipated path forward was and what their anticipated mortality was. So it really spawned a nice collaboration. That's nice to hear. I suspect that there are folks here who are navigating a thornier experience working with surgeons. You know, there are a lot of pressures on everyone's time. So it's nice to hear that it can be done well. And so we appreciate you sharing your experience with us. Are there any questions from the audience? I want to make sure that we still have a little bit of time if there's a question. Hi. Thanks for the great talk. A question about the tricuspid procedures. And I'm not going to mention everyone on the panel. What recommendation or experience do you have about staging the procedure versus altogether? And what recommendation or experience in terms of what to re-implant, say, for a pacemaker-dependent patient? It's an awesome, awesome question. The logistics of doing these procedures together is kind of tricky. And you also don't know necessarily what the result of your extraction is going to show. So, you know, of course, I do know programs and cases that are planning to do these together. And I think if so, that should be more of a one-off thing. We stage our procedures. We would do our extraction first. You know, sometimes we're surprised and the TR improves. And we kick the can down the road. And that's awesome. You'd hate to have your structural team be standing there, waiting and then walking away. So our preference is to stage those procedures. But there are some patients where that's just not the case. And that collaboration, that's why it's so very important. You know, you also look at, like, that person's day as a patient. And, you know, whenever – I always think about this when we do things together. And, you know, there's a lot here about concomitant or combined procedures. The risks aren't always the same. And so, you know, I think it's important to look at, like, that person's day as a patient. or combined procedures. The risks aren't additive. They're multiplied. So you do have to kind of think about what you're putting someone through, you know, whether it's an hour of general anesthesia or two or three. So you really – I think, personally, you have to be really mindful of that as well. I think sort of embedded in your question, which is an excellent one, I think we're all grappling with this along with our structural colleagues, is, you know, how likely is it for us to disturb the tracuspid valve apparatus in such a way that the planned transcatheter solution is no longer an option? You know, I think that's really the big question. And I know early on there was a lot of anxiety in the tracuspid interventionalist space about that. We haven't seen that borne out. I don't know if there's people here who have data I'm not aware of, but certainly unaware of anything suggesting that this is a big problem. And so on the one-off chance, on the one-off case where it does make sense to combine procedures, I think it would be reasonable. It's reasonable to do that because this risk of tracuspid valve disruption hasn't really borne out, although, you know, time will tell. All right, any other questions? Okay, then I'd like to thank everybody for being here, and thanks so much to Philips for supporting this really important session. I know I had a lot of fun, and I learned a lot. I hope you did too, and I'll be sticking around. I suspect the panel members will be as well if there are other questions. So thanks for being here, and thank you to the panel. Thank you.

lead management

patient care

delayed extraction

tricuspid valve

abandoned leads

infection prevention

collaboration

extraction techniques

procedural complications