Thank you so much. So as mentioned, I'm going to talk about introduction to device and lead management. I don't have any disclosures. The objectives for the talk, I want to define the terms for lead removal so we have a universal language, which is often a bit confusing when it comes to extractions and removals. I'm going to review the indications for removal of devices. I'm going to discuss important device diagnostics that should be heeded before making any decisions regarding removal, and I'm going to review risk stratification and complications, as well as specifics of the procedures for device removal. I will end with a few cases that I just wanted to go over as examples of device removals. So this is mostly rooted in the 2017 HRS consensus on device lead management and extraction. As far as the definitions are concerned, the first thing you should know about is non-functional leads. Non-functional leads are unusable leads. Whether they're connected to the generator is irrelevant. They're just electrically dysfunctional and they're still in the pocket, at least, but not something you can use. Abandoned leads, on the other hand, can be functional, and they're just left in the pocket and not connected to the generator, and that's the only criteria for them. Lead removal means removing pacing or defibrillator leads at any time after the implantation using any technique. The explantation procedure for leads means that you remove the lead within one year of implant, and you're not using any tools you wouldn't use to implant the device. So this is usually, the reason this is important is because within one year, most of the explantation for devices can be done in the EP lab. You usually don't need CT surgery backup. You don't need the whole setup that you would beyond one year. Lead extraction means you are actually removing the lead that has been implanted at least one year ahead of time, one year before the, after the implantation, and you're using tools that you normally wouldn't use to implant the leads, such as specific sheets or lasers or other tools that, such as a femoral workstation that you would not be using to implant the leads. As far as the outcomes are concerned, complete procedural success means that you removed all the targeted lead materials from the vascular space, and there's been no disabling complications in that. This is permanently disabling complications, so if you have a minor complication, it doesn't count against your procedural success rate, but as long as you were able to remove the targeted material. Clinical success is defined a bit differently. What this is defined as is that you have success in removing the material from the intervascular space, but you're still successful if four centimeter or less of the lead material is still there. However, if it compromises your goals of the procedure, that is not considered to be a clinical success. For example, if you have endocarditis, and you need absolute removal of all the lead material, and there's still some retention, that's not considered to be successful. Or if you have a arrhythmogenic substrate at the tip of the lead, and the tip of the lead fractured, and you're still having arrhythmias, that's not considered to be successful. Failure, again, if you are not able to achieve success, or if you develop permanently disabling complication or death. Lead removal with clinical success, again, is counted as success if, again, if your goals are met, you don't have any negative outcomes or death, or you're still able to retain about four centimeters or less of the material, and it would still be considered to be a successful procedure. Indications for the removal. So the most common indication is infection, and the infection indications are class one indications for removal. If you have pocket infection, whether or not you have bacteremia, that's usually a class one. If you have left-sided endocarditis with vegetation in the valve, or even with or without right-sided involvement and positive blood cultures, that's a class one. If you have device-related endocarditis, that's definitely an indication. If you have persistent or auto bacteremia with no other source, or you have persistent bacteremia with the probable cause being the device, that's also a class one indication for removal. Other indications. So if you have thromboembolic events because of the lead or a lead fragment or thrombus or vegetation on the lead, that is a class one indication. A lot of the other indications are related to SVC patency. So if you have occlusion of the SVC that is symptomatic, especially you could, that's a class one indication. If you're trying to maintain the patency and have limiting symptoms, it's a class one indication. If you have a stent that's going to be deployed in a vein where the leads are going to be jailed, essentially, that's a class one indication, usually subclavian area for subclavian stems. If you have ipsilateral venous occlusion and you're going to add more leads, it's a class two indication. Chronic pain, that does occur. It's rare that you have to remove a lead or device, but it's a class two indication. Life-threatening arrhythmias, every once in a while that the substrate is such that where your leads are placed can become arrhythmogenic. It's rare, but if that was to happen, very rarely do you have to remove the leads. I have had to do this as well for the treatment of malignancy, especially if someone's getting radiation for the chest. And if the device is in the way of your radiation to the area that's required to be radiated, you may have to remove or move the lead, and that's a class two indication. If you have more than four leads on one side or five leads through the SVC, that is a class two indication as well. So if you're upgrading devices, if you have abandoned leads, it's something to consider for the future just to maintain SVC patency. However, it's a class two way, it's not a class one. If you have abandoned leads that are interfering with the function of the actual device, that's a class two way. Design failure, there are recalls every once in a while, that's a class two B indication, as long as it's not already a failure, and it's a potential for failure, that's a class two B indication. A lot of times this is addressed during the time of generator change. In this day and age, it's extremely rare that the MRI is the only modality that you need to use for any diagnostic purposes. But if it becomes the case, in the extremely rare circumstance that's going to make a life-changing decision for your patient and MRI is essential, a class two B indication for lead removal or device removal is also present there. In very unusual circumstances, if the leads function normally and not recalled, if the patient is insistent for any other reason, it could be a shared clinical decision making and it's a class two B indication, not something that's encouraged, but it can be done. This is, again, a summary of these slides, but what I wanted to actually show you was this picture. And what this picture is showing is somebody who was reported to have an immunocompromised status and had multiple device infections with multiple implantations and removals for by B device and ended up getting occluded on both sides when they presented in a BT storm with the device that was at EOL plus was infected. When they removed the device this time, they could not place it again because of all the bilateral occlusion that we see. And you could see a lot of collaterals, especially the azagus veins and how dilated they are, even tortuosity of the skin vessels that are present there. So in this circumstance, I mean, it got to the point that they had to place the whole by B system epicardially. Again, this is rare, but that is why you have to understand that without infection, SPC stenosis and SPC patency is something that's mentioned multiple times in the guidelines. Switching gears a little bit, the strongest indication, one of the strongest indications for removal is infection. So if you have a suspected infection, whether it's pocket or systemic, the workup is essentially blood cultures and TEE. So if you have positive blood cultures and TEE that shows either valve or lead vegetation, you have to remove the device and then you treat it with antibiotics, almost similar to any endocarditis treatment. If you have blood cultures that are positive, but nothing on the TEE, you could consider removal of the device and microbial therapy, or you could leave the device, treat with microbial therapy, check for persistence. If you have negative blood cultures and nothing on TEE, if it's a localized infection, you treat with antibiotics. If there's nothing, no localized infection, nothing on TEE, nothing on blood cultures, you just observe. If you do end up removing the device, the reimplantation specifically mentions at least 72 hours after negative blood cultures. I think most of us are a bit more cautious about that. Usually it's weeks after your treatment, and remember if this is treated like endocarditis, it will be six weeks after the implantation. So a lot of times when people are dependent, you end up putting in a temporary that is externalized, a permanent device with the permanent lead, and you let these people go to a rehab facility, let them complete their course of antibiotics, and then consider reimplantation once they've been negative. This is just in regards to pocket infection, which is usually just superficial with discomfort, erythema, swelling, purulent drainage, or in worse circumstances, percutaneous exposure. So if you see these people early start antibiotics, if they still have persistent symptoms of pocket infection with or without systemic symptoms or fever, again blood cultures, TEE is something you should consider. If the blood cultures are negative, you could just do antimicrobial therapy with consideration for what the microbe is. If blood cultures are positive, you have to treat the microbe that you find. Staph aureus is notorious, and you have to treat it for four weeks. If there's something on the TEE, you may consider removal. This is an interesting finding that I saw in a paper by Halun, and an interesting thing about this is this is over a two-year period. So this is weeks after implants, this is months after implants, this is two years after implants. So realize that sometimes you see a little bit of redness after the implant and you just count it, but when you follow these patients out, it may be something that is insidious and may present to you a bit later. So just the importance of device management and follow-up is very important in these patients. So if you have bacteremia and you don't have a cause, you need to remove all the other factors that could be causing an infection. If you think there could be a UTI, you treat it. If there's someone who has a Foley, you remove it. If they have center lines, you remove it. If you have dialysis catheters, you remove them and potentially you have to re-implant them, but you know you remove all the sources initially. Then if you don't have any identifiable source and you don't have any other proof of any other source of infection, then you have to consider the micro. COAG negative staph, staph aureus, proprionibacterium in Canada, these four you have to remove the device. So streptococcal infection, enterococcal infection, removal can be considered or you could observe with antibiotic treatment and then remove if the vectoring is persistent. Gram-negative bacteria or pneumococci, usually observation you don't have to remove. You treat with antimicrobial therapy and you end up eliminating the disease and you have to re-evaluate for clearance. This is interesting. This looked at pocket infection with negative blood culture and nothing on TE, pocket infection with positive blood cultures and vegetations. This looked at just a blood culture that was positive with no pocket involvement. So out of all of these at one year, the people who had just a localized pocket infection and nothing on TE or blood cultures did reasonably okay at one year with over 90% survival. If you had TE or blood cultures that were positive with the pocket infection, then your survival was over 70%. But if you had blood cultures that were positive, even though you did not have a localized pocket infection, again the survival one year is just over 60%. Risk factors for infection, multiple ways of looking at this, but there are patient-related factors, procedure-related factors, and microbe-related factors. The risk of infection over a one-year period has traditionally been anywhere from 0.5 to 2% for new implantations. For secondary interventions such as generator changes, lead repositioning, upgrades, it's anywhere from 1% to 7%. So patient-related factors, advanced age, CKD, dialysis, diabetes, heart failure, COPD. If there aren't any sort of immunosuppressive medications, malignancy, if they're anticoagulated and they develop a hematoma, those are risk factors that are specific to the patient. Any pocket re-intervention, as I mentioned, carries a significantly higher risk. Hematoma carries a very significant risk of infection over a short and long-term period, longer procedure duration, and along with that goes the number of leads that you're replacing as well as the nature of leads you're placing. And for pocket hematoma, it should also be noted that ICDs have two and a half times the risk of pocket-related events rather than pacemakers, probably just because of the nature and the size of the generator. Operator experience matters, and the lack of prophylactic antibiotics do matter. Highly virulent microbes are obviously going to cause more problems than the other ones that we had mentioned. Device diagnostics are the other tools you have if the patient is not infected to assess whether there needs to be removal or not. If you have extremely short intervals, whether it's in your atrial or ventricular lead and it's non-physiologic, it should be a marker for potential problems. If you have sensing and impedance trends that are suddenly abnormal, it should raise alarms. Sometimes it's not suddenly abnormal and it's a slow process, but if it becomes alarming at a certain stage, you have to consider that there's something wrong with the lead. Sometimes you have noise on the leads, that's the first sign of any issues with the lead itself. Inappropriate shocks because of over-sensing or noise can be an issue. If you actually have an arrhythmia and you cannot deliver a shock, you deliver ineffective shocks, you have to consider potentially something needs to be done with the leads. Advisors recall, those we have discussed, if you have abandoned leads or you're down-regulating or upgrading devices, especially for SVC patency, that's something to be considered. As far as risk factors for the extraction procedure itself, so again, there's multiple things here. There's patient-related factors, there's operator and center-related factors, which means that you're doing less than 30 in a year, and device lead specific risk. Is it a dual-coil lead? Is it a recall lead? Is it a lead that tends to fracture more easily when you're extracting? These things need to be considered. As far as patient-specific factors, older age, women carry four and a half times risk of a man for multiple reasons, and low body mass is also found to be almost a two-fold risk. If they've had a stroke or LV dysfunction, that's two-fold the risk of complications. Heart failure, this is all over the place, 1.3 to 8.5, and probably the reason for this is because heart failure is on a spectrum, and the sicker you are with heart failure, which a lot of our patients are, the more likely you are to have a complication. Renal failure, this is not just in EP data, this isn't all surgical data. People, especially on dialysis, tend to do worse than patients that are not in renal failure on dialysis. Other risk factors, diabetes, any coagulopathy or platelet dyscrasia, anemia, all are risk factors for higher risk of bleeding. Again, the number of leads extracted matters. The more leads you extract, the more complicated your procedure is going to be. Again, we mentioned dual-coil procedure. Infection carries a higher risk, mostly because your patients a lot of times are sicker, and a lot of times these are non-elective procedures. So these patients are usually a lot sicker, and I'm going to discuss that in a little bit more detail. Operator experience does matter, and if the patient's had prior heart surgery, the risk of complications actually, if anything, goes down. But having said that, your backup surgeon may be less optimistic about the outcomes if something was to happen. Risk factors, again, just mentioning it in a different manner. I mean, the device-related things we talked about. The couple other things that we haven't talked about is that sometimes you have a lot of calcification in your blood vessels, and that makes the blood vessels a bit harder to maneuver. You're going to have more power tools that you're using, and that's going to lead to a higher risk of complications. Also, sometimes when you're getting access, you extravasate outside of the blood vessel and then re-enter the blood vessel. And you may not notice that when you're actually getting access, but when you have put a long and large sheet or power tools over the lead into the extravascular space and come out, remember, you're going to have a higher risk of bleeding there, not just intravascular, but you're going to bleed into the pleura. You can create a lot of problems that way. You could have an SVC tear that's considered to be a tear, but you may be bleeding close to that area. Venous occlusion, obviously, is going to lead to more problems because you have a lot of, depending on the age of the leads, you have a lot of calcification and fibrosis there. When you need to use femoral extraction, that usually is a harbinger of worse things because there's more binding there. Obviously, it was more difficult to do through the non-femoral approach. Those patients have a higher risk. And the more power sheets that you use, the higher the risk of other issues. If you dislodge non-target leads, which does happen because of binding, I mean, that increases your patient-related risk. And as we mentioned in the prior slide, if you have a non-elective case that's urgent, usually those patients are sicker and they do worse. And the other thing I wanted you to notice is this gives you the risk of major and minor complications. And I want you to pay attention to the fact that the risk is all over the place depending on what study you're looking at. And part of this is also, it depends on the population you're extracting. If you're extracting older women, sicker patients, people on dialysis, you're going to have a higher risk than someone who's younger, healthier, does not have a dual-coil lead. So you need to consider patient, center, and the device-related factors before giving them a percentage of risk. In general, you should consider patients who have had a device in for less than five years to be a lower risk, five to 10 years to be moderate risk, more than 10 years to be a higher risk for complications. Plus, you have to look at patient-specific factors, device-related factors, and the situation that the patient's presenting in. So when you look at the really major factors, it's usually about 1% to 2% is what I tell people. You're looking at death, avulsion, vascular laceration. Respiratory arrest is rare. Hemothorax-requiring intervention is rare. Massive PE is rare, but it can happen. You have to be aware of what's on your lead. And pericardial effusion-requiring intervention is less than 1%. Minor complications, again, this is, again, all over the place. But, you know, I do mention it to patients that they could get injury to their heart, lung, blood vessels as a way of explaining that there could be a lot of other problems that can occur. So hematoma-requiring evacuation, that probably is the most common thing that can happen. Bleeding is rare. I will tell you that get blood ready just in case you have an SVC tear. I have blood held in the OR before I even start the procedure, and I'm very OCD about doing my checklist before the procedure. So make sure that you have everything that you need for that procedure. Pneumothorax, again, about a 1% risk. Worsening cuspid valve function is interesting because it's rare, but you also have to consider that when we implant the leads, and it doesn't happen very often, sometimes the leads can go through the valve leaflet. And when you extract, you could worsen the TR that's through the valve. The other thing is the lead could adhere to the valve, and when we're removing the lead, a portion of it could evolve a bit. So you have to be careful about that. Your intraoperative TE will give you some idea about that. PE is, again, rare. Any venous thrombosis, migratory lead fragment, or pericardial effusion with no intervention, again, not very common, but it does occur. The setup for extraction, mostly the most important thing that you can do for your extraction program is to be very prepared. Your cardiothoracic surgeon is your best friend during the procedure. So I usually, when you come in the morning, you need to make sure your surgical team is there. You need to make sure your perfusionist is there. I usually have, actually, the bypass machine outside the room before I extract, especially for devices that have been there longer. I want to make sure that everything is in place. The chest x-ray preoperatively gives you a lot of information. I would argue, actually, that anyone who has older leads should definitively get a chest CT, but again, it depends on your institution and what you want to do. But chest CT, the reason it's important is because it could show you binding. It could show you extravasation. And I usually have not been using contrast, but if you use contrast, you can show extravasation outside the vessel, too. The other reason the chest CT and the x-ray are important is it gives you an idea about the positioning of the leads. You also are sometimes surprised when people present from other facilities about abandoned leads and remnants. So these are useful tools to have. Basic lab work is important, along with, like I mentioned, type and screen, type and cross, make sure your blood is there, especially for older devices. You have just moments if you have an SVC tear before you need help acutely. Interoperatively, our chair line is very important. As far as venous access, I have to talk to my anesthesiologist and my cardiac anesthesiologist. When you have a cardiac anesthesiologist, they understand very well. Sometimes you get a non-cardiac anesthesiologist, and you have to remember that your femoral vein access is going to be very important. I put up a bridge balloon for my cases anyway, but when you get femoral vein access, the reason it's important is because if you have an SVC tear, remember that anything SVC-related for return is not going to be very useful to you during that period. So you have to have femoral vein access for anything that's especially older with any risk of SVC tear. Stopping anticoagulation, that applies for implants. That definitely applies for removals. And the other reason is we usually have a lot of bravado about moving forward with our procedures without stopping anticoagulation. But remember, not only do you have a risk of infection and having to have re-intervention on the pocket. But if you were to have a complication, your surgeon definitely would want people off anticoagulations and potentially anticoagulant therapy before taking them to a door. So it would make a bad situation worse if you haven't considered that preoperatively. Postoperatively, the anticoagulation will depend on your findings during the case as it does with any device implantation. The interoperative TEE is the single tool that is the first warning for something to happen along with your arterial line. So make sure that when you start doing extractions and not just removals that are within a year, not just implants, but any extractions, make sure you do a TEE. Postoperative care, not only is it the regular device-related care that's important, but also you have the femoral care that you have to provide. And these patients are a little bit complicated, but surprisingly, in the postoperative period, as long as there hasn't been any issues, the follow-up and everything else is just like a device clinic and device routine follow-up that you would have. I'm gonna review some cases that I'm gonna do in the interest of time over a brief period of time. But the first case is a patient who had a defibrillator implanted in 2009, a heart failure with reduced DF, non-ischemic cardiomyopathy, COPD, and dyslipidemia, not dependent at all, RV pacing was less than 0.1%. And what you're seeing here is trends of the RV lead. So here you're seeing the impedance is climbing and the RV threshold has climbed suddenly as well. The R waves are still reasonable, but this device obviously has a problem and this lead definitely has a problem. And what I wanted to show you here is there's a few things that are going on here. So obviously you have a dual coil lead and this is the balloon that occludes the SVC that I implant during cases, especially if the device has been there for five years or more. You have a stiffer wire, a Benson wire that's there. And when you inflate the balloon, you see that this lead has contoured to the wall, which means it's adhered to the wall. It's not just jailing. And this happened during the inflation of the balloon. Then it was very adhered and the proximal coil started unraveling a bit. The helix did not retract. This is a 14 French inner laser sheath. And this is the outer sheath over it. We did the tunneling approach. We were able to get past a lot of the fibrosis. And once you got to a certain point, the lead was able to come back on its own. So this procedure went well, but this was, you know, with a dual coil lead that was a bit older and not retracting, you could have had a lot of problems. This is a 48 year old female with complete heart block and had a pacemaker implant in 2003, upgraded to a defibrillator for postpartum cardiomyopathy with persistent heart failure with the LV lead implantation with the low by B pacing and RB failure. So this is inter-procedurally. What I'm not showing you is the venogram, but there's occlusion of the subclavian here. And as we're trying to remove the LV lead, what you also need to know is the abandoned RB lead is also pulling back with the lead, as is the defibrillator lead. So all of these leads are bound together and you're seeing binding here, you're seeing binding here. And it's very difficult to remove any of these leads individually. The RB lead here starts unraveling during the procedure. The abandoned RB lead starts unraveling, but that has to be removed first. Even the atrial lead starts moving because there's so much binding involved. Thankfully, we were able to remove the pacing lead, but with it, the RB defibrillator lead pulled back. However, we were able to maintain patency and the lead, even though it was frayed, was able to come out completely. We were able to implant the RB defibrillator without any issues, and this was the final result. So everything ended well, but obviously this is not, where you plan a procedure of removal of one lead and a lot of other things start coming out. So this is a 67 year old lady with six sinus syndrome with dual chamber pacemaker, 2012, with some risk factors, who has a lot of ATAF notifications suddenly, did not have a significant history of atrial arrhythmias, and all of a sudden starts getting a lot of notifications. Otherwise you'll notice the impedance is a little high on that lead as well. So the intervals for the V to V are stable, but the atrial intervals are all over the place. And you'll notice it's less than 200 milliseconds. So there's a lot of non-physiologic intervals, about 150 milliseconds that occurs on the atrial lead on multiple occasions, which should give you a little bit of a pause. And when you look at the EGMs, your atrial lead has a lot of noise, and it is sensing as AFib on these occasions. And again, this is an example of longer periods of this where it's sensing the noise. There is noise on the RV lead too. We were able to program around that, but the atrial lead, that was difficult because if you look at the size of the signals for noise versus the size of the signal for the actual atrial signal, there's not that much of a difference. So this was not something you'd program against. And you can see there's multiple episodes that were recorded as atrial arrhythmias in this situation. So this lead had to be removed. This is just an example of paying attention to your multiple notifications that may come on your devices. So this is a 51-year-old male with heart failure with reduced EF, with a defibrillator with a non-functioning atrial lead that was implanted in 2018. And it was not implanted at our facility, but he also had some of the risk factors, COPD, diabetes. And he was dependent on insulin. He was on dialysis. He was admitted with staph epidermis bacteremia at an outside facility, and he was treated with ibuprofen. And remember, staph epi is one of those organisms where you could treat it with antibiotics and follow them. So he was admitted there for two weeks, treated with antibiotics. He had a fistula that had been placed for dialysis earlier, but it had very low flow. It was not usable. They were using a tunnel catheter, and the tunnel catheter was removed there and replaced already. And two weeks later, he was sent. And as you could see, at our facility, he still had persistent bacteremia. He did not want the removal of the device. So we actually ended up removing his tunnel catheter, re-implanting another one. Unfortunately, even if you give a 48, 72-hour period, he still remained bacteremic here. So finally, he agreed to the extraction. The device and the lead were removed, and after that, he had no growth. And this is just an example of persistent bacteremia afterwards. So he had antibiotics for this period of time, but after the antibiotics were stopped, he still remained negative. This is an interesting case of a 49-year-old lady who came with complete heart block that was congenital. She was implanted in 1982. Initially extracted shortly after with re-implantation on the contralateral side, and she presented with high Rb lead impedance and threshold. I'm just showing you the slide to show you the chest X-ray. So she was extracted initially at another facility, and this little piece is a remnant from her prior left-sided device. So the question from the audience would have been, what would you do with this? Would you attempt to remove this? And here we are during the extraction. The answer is no, because it's been there since 1982, and it's very embedded into Rb, unless this was a very essential part of the procedure. So this is one of those situations where this would still be considered procedural success if you remove the lead without removing the small remnant. And the reason for that is because if you try to remove this remnant, you're asking for more problems than you are asking for a reward, because this is something that's been endothelialized a long time ago. This would have to be a surgical removal, rather than you trying to fish this out with any tools that you may have without a rail. And you can also see the Rb lead for her is starting to extravasate here already too. So this is externalized material from the lead. So I just wanted to show you this slide to show you that this removal of everything is not necessary for successful procedure, especially if it's not pertinent to the procedure. She's not having arrhythmia, she's not infected. If it's been there for a long time, please do not undertake more risks than you have to. This is a 57-year-old male. He, this is a very unfortunate tale that I'm gonna discuss with you, but 57-year-old gentleman, heart failure, DOCF, had a history of CAD, GI bleed, hypertension, cirrhosis. He had a single chamber defibrillator implanted elsewhere four weeks prior to presentation. And after that period, he had developed very large PEs bilaterally. He was then admitted seven days prior to presentation to us with persistent MRSA bacteria and septic shock. They were not a facility for extraction. So he was treated with antibiotics. They did a T, he did not have any vegetation. They chose to treat it conservatively. However, he started worsening his white count even after he presented to our facility, started climbing. His platelets were initially terrible in the antibiotics, but started improving with change in antibiotics. He was anemic, but for us, he continued to grow MRSA. And remember, this is about, I would say about 10 days after presentation initially. Our echo when he presented showed an EF of 20% potential for some valvular vegetation and small to moderate pericardial effusion, suggestive of tamponade. Remember, this is a device that's been placed only four weeks ago. So here on this slide, you're seeing this mass that's supposed to be connected to the valve. So this is the endocarditis that we're discussing. This is a four chamber view just to show you a circumferential pericardial effusion. And would you do anything differently at this point rather than just remove the lead? Well, the patient had presented over the weekend and I was not on call, but one of my partners was good enough to get a CT scan because of pericardial effusion. And if you look at the pericardial effusion, the RV lead, even though this is not a very well gated CT, seems to have gone through a bit through the endocardium into the pericardial space. So that may be the right reason for pericardial effusion. The question is, do you extract? Do you put a drain in and extract? Do you surgically remove the lead? Remember, this is a lead that was placed only four weeks ago. And again, this is about 2.3 centimeters in circumference for the effusion. Well, the patient started getting worse acutely. He had hypoxemia, tachypnea, tachycardia. I took him to the hybrid OR. He actually had a rest as he was getting induced with anesthesia. He was getting sicker by the minute. And we decided to just remove the lead because he looked very tachypneic even that morning. This is the intraoperative TE and you can see the pericardial effusion that's present here. Obviously his LV is not moving much. And this is, again, the lead that's coming through. And this is during the removal, the effusion stable. And this is also showing the, giving you the, you know, the idea about the pericardial effusion that's not terrible right now. And here it looks a little bit worse, but what I wanted to show you was since it was only a four-week lead, the helix retracted and without the use of any tools, this lead came out very easily. So this explant occurred without any problems. And the T, the last image after the extraction showed that the effusion remained small. So the biggest concern that, you know, someone had with the effusion was, is there going to be a tampon on when I remove the lead? However, as he started getting sicker, we just ended up removing the lead with our surgeon as backup. And staph grew from the pocket as well as from the remnant of the tip that I sent. However, after the procedure, because he presented so late to our facility, he couldn't be extubated. He remained ventilated. He continued to descent. His pressure requirement increased. His lactate kept rising and eventually care was withdrawn. So you have to consider, depending on the virulence of the organism that the patient presents with, there should be an earlier step to either remove the device or send to a facility where the device removal can occur. And sometimes we like to optimize our situations and have backup ready, but not always the case where all of those are able to be done in a timely manner. I wanted to end up on a more cheerful note. So I wanted to talk about the first leadless pacemaker extraction that was published by us. And before that, the other ones had been a bit more unsuccessful. So I just want to show you some images for that. This is a lady who presented with the VR device, with a history of pauses. She had multiple occlusions with DVTs and had also a lot of issues with access and subclavian stenosis bilaterally. She ended up getting a leadless pacemaker with chronic atrial fibrillation. 15 days later after presentation, she had dizziness and fatigue and the threshold for the leadless pacemaker had risen. The chest x-ray was stable. So this was considered to be a micro dislodgement. And I'm sorry, I tried to make this image as straight as possible, but what I wanted to show you was the ephemeral workstation that was necessary for this. So we went through the actual sheath for the device. We put a agilis through it. And again, this occurred over multiple hours with multiple tubes that were tried. But what we had to do essentially was we had to use two snares, one to snare the tip of this and one to get the time. And we had to straighten it out, make it coaxial to the agilis. Then we had to pull the whole thing into the implanting system. And that was, again, so this image is from the paper that we've used, but the part of it is you're using it in tandem with the introducer and the agilis. And you're hooking onto the tine and to the forefront of this, you're making it coaxial and that's the only way you could pull it back into the lead. So now that's part of the extraction protocol for leadless pacemakers, but this was an interesting case. And sometimes you're presented with challenges that you wouldn't expect for extractions. So I know that we have some time left. I wanted to end early just in case there was any questions or anything else I could address. All right, thank you. That was great. As you know, our audience is often fellows, and people are probably on their way to interview for jobs and things like that. So I guess, how do you counsel your fellows who are looking at jobs where they may be expected to be the primary lead extractor or start an extraction program at an institution that's not currently doing it? How do you talk to them about doing that safely and the setup that they need? Thank you, that's an excellent question. So they had an extraction program here that had elapsed. And when I started the extraction program here, there were a lot of parts of that that were moving. So we initially did not have, we were thinking about doing it in a lab, just our EP lab, where you have to consider your surgeons and what kind of backup you're gonna need. So the first thing that has to happen is you have to meet with your surgeon, your surgeons. And you have to make sure that they're comfortable doing these. If they are not, maybe go to the training facility. When I did the training, again, for the facility, we went to actually a surgeon that was doing extractions. And they had a very specific protocol for them. So that makes it a much easier transition if you're starting in a program. You need to meet with your surgeon. You need to make sure that they have done these before. You need to make sure that if they haven't, they go through the training for that as well. You need to make sure that your center is in agreement with you for TE provision, provision of a room where all of these things can be done. You need to make sure your perfusionist, your surgeon, everyone's already there. You need to make sure your anesthesiologists are comfortable when you're doing these procedures. And I actually have a very specific checklist of things that I do before the procedure. So my procedural start time is 7 a.m. So I'm there at six o'clock and I make sure my device has been interrogated and has to be turned off. It's there. The reps are there. The rep is there for the actual device. The rep is there for the extraction. The room that I need for this, the hybrid is available. I make sure the blood is already down there. I make sure my surgeon's already down there at seven o'clock or at least in the facility. So you have to be very OCD about this and you have to make sure that there's certain things that you need. I would actually encourage fellows that are looking for positions that require extraction or they want to do extraction or initiate extraction programs. I would tell you that if you have a mentor that you would like to sort of mirror, have the mentor come in for your first extraction. Make sure you have a checklist of needs that are necessary. And some things that you may want that may not necessarily make or break the deal, but make sure that you have all of those tools that you present to whoever is hiring you and say, are these provisions available? And you talk to the surgeon, make sure they're comfortable. You make sure that when you first start doing extractions, if anything, you're very careful. I would tell you for the first 20 that you do, get a CAT scan for all of them. It does not, as long as they don't have renal failure, it just gives you more information about this. And eventually you may get comfortable to the point that you don't need to do that for every procedure. You need to also make provisions for emergencies when emergency cases come through. What is very difficult to do as a new physician, as you already know, is say no. But if it's a very, very high risk case, the one thing that's very difficult that we don't do very well and surgeons do a much better job of is to say no when a surgeon does not want to do the backup for your extraction and you have a high mortality, that is something that is a very difficult discussion with the patient. And sometimes that does occur too. So keep all of these things in the back of your mind when you first start your job that may require extraction. Great, thanks. And I guess maybe I'll ask you about your setup. At our center, we do them all in the hybrid OR. None of them are really done in the EP lab unless the lead is less than a year old and the surgeon is actually scrubbed with us. So I don't know what your setup is or how you would recommend these are done, but maybe you can talk to that a little bit. Sure, I think every center is a bit different and it depends on your surgeon, your relationship with the surgeon and how your labs are set up. Our labs, can they be available for open heart setup? Yes. Are they optimal for it? Absolutely not. So because of that reason, we do do everything in the hybrid. It also has a better fluoroscopy system and a provision for a laser space than our regular lab as well. So because of that, I do end up doing all the leads that are over one year down there. A lot of times it does not require power tools if it's been there for less than two years, but at the same time, just in case that is needed, we do always book everything in the hybrid. Our surgeons don't actually scrub in with us, but one thing I do do is if the lead is more than 10 years old, I usually have, you know, our surgeon's extremely affable and available. So I text him in the morning and he comes in and says hi to the patient. If the lead is more than 10 years old or if I have any significant concerns and he comes in and introduces himself to the family. So I think that really helps, but I could tell you if I ever need him, he's there, he's in the facility and he's actually very conscientious about this. He's the one who does back me up consistently. And he says that he refuses to do any cases at the same time. Sometimes I do cases with other surgeons that are in cases simultaneously. Then I make sure that we have two, you know, we have two setups. And I usually find out if they're on pump or off pump. So if I were to extract, I do it either before they go on pump or I do it after they come off pump. So I may do the rest of the work where I open up the pocket to do, you know, do the rest of the access and everything. Wait for them to either, if I am there before, I do the extraction before they come on pump and I let them know that please wait for me to finish the laser portion of this before you end up, you know, coming on pump or I wait for them to be done if they're already on pump. So that's something that we do coordinate every once in a while. I mean, it's great if you have your surgeon scrubbed in with you. I think it's very dependent on center and how busy your surgeons are and, you know, how much of time they wanna commit to this. But I, you know, again, it's a compromise for the surgeon and for you. Obviously they're gonna be doing some of the surgical extractions too. Yeah, obviously billing comes into play and you have to sort of figure that part of it out, which, you know, we've worked through. And then I guess I'm curious, do you have any wishlist for tools that may improve safety? Yeah, I think the one thing that has helped a lot is the bridge balloon. And, you know, it's improved safety significantly because it buys you time. With any significant SPC tear, you have minutes before mortality is 50%. In five minutes, you know, your mortality is already 50%. If you don't have a surgeon scrubbed in, that's opening the chest. So with the bridge balloon, I would tell people that even if you're not sure you're gonna end up needing it, I would use it for anything that's over five years, as long as your institution is not worried about the cost. And it's actually, compared to everything else we do, it's actually not that expensive. You know, I would tell you to just open up the balloon if anything is older than five years for sure. When you first start out, maybe even after a year or any cases you're doing, so you get used to the way you do this. So you have created a rail, you put it in the SPC. Sometimes, you know, when I first started doing them, I was seeing that the balloon was migrating a bit or the wire was migrating a bit. So you have to develop a system that you're comfortable with. The first time you wanna use it is not when something bad happens. So I would always put up at least a wire, you know, and the balloon otherwise. Things that would improve safety, obviously the tools are improving. I wish there was a more compliant laser. Having said that, you need a little bit of stiffness to go through a lot of areas, but I wish there was a more compliant laser that didn't cause as much damage. I mean, if you look at the tip of the laser sheets, they're very aggressive. So you can only imagine the type of damage that they can do to the areas that they go through, but it's necessary for very fibrous calcified tissue.

lead removal

non-functional leads

abandoned leads

lead extraction

indications for lead removal

risks and complications

case examples

starting a lead extraction program

bridge balloon