All right, welcome everyone. Thanks a lot Nishant for the invitation to speak. It's impossible to completely avoid complications in the EP lab, but we'll talk about strategies for kind of minimizing and managing complications as they occur. Here are my disclosures. So just as an overview, we'll talk about minimizing device complications. We'll talk about minimizing complications during ablation procedures. And at the end, I'll have a few slides on just sort of strategies for kind of addressing complications when they occur. So in terms of minimizing complications, I'm just, this is, I don't know that there's really a right or wrong answer here, but out of curiosity, maybe you guys could weigh in on what you quote as the rate of a major complication for CID implantation. I'll let it go for maybe a minute or so. I thought it was 50-50. You might be on your Peloton during this. There was a chance. OK, great. So it looks like the majority said less than 1% risk of a major complication. For us, for whatever it's worth, we quote a 2% to 3% overall risk of a complication. And I think most people would agree that less than 1% for a major complication. OK, what do the observational studies tell us about the actual rates of pacemaker complications? So this is a review of 72,000 now pacemaker implantations published in 2017. These were older men mostly, the majority of whom had dual chamber pacemakers placed. These were implanted in 2010 to March 2014. And as you can see, the acute rate of complication, and these were pretty legitimate complications, including infection, thoracic trauma, pocket issues, which may or may not require intervention. But in the acute phase in one month, the rate of complication was seen to be about 9% overall. And what made up the majority of that? Endocarditis, actually, not just a little bit of skin infection occurred at over half a percent. Thoracic trauma occurred quite frequently at 3.5% or a little bit above that. And lead complication requiring revision was also a major issue. In terms of long-term complications, the percentage was about 5% to 6%. Again, with lead complications being a major issue, and infection kind of rounding that out as well. One thing to kind of notice, and you've probably heard this from your attendings, is to be very judicious about the use of adding an atrial lead, if that's something that's really needed or not. It's clear that patients with dual chamber devices had a higher percentage of their complications made up of lead complications, both in the short term and in the long term. And if we look at the actual numbers, you can see that both the risk of a lead complication requiring revision, as well as the risk of thoracic trauma, either pneumothorax or hemothorax, was higher in patients who had that additional lead placed. So it may seem trivial at the time, but statistically speaking, you're more likely to cause a complication with the additional lead. So why were those numbers so high compared to the numbers that we sort of quote our patients and that we think of? It may be that many of those 70,000 pacemakers were placed in centers with less experience than more experience. This, I think, is a very useful study from Germany, looking at 430,000 pacemaker implants and looking at significant complications, meaning those requiring intervention. So not just a pocket hematoma that someone watched. This was something that required re-intervention. And you can see that there's a significant trend toward a lower rate of complication in sort of the higher volume centers, especially when it comes to pneumothorax, maybe not so different in terms of effusion as that's infrequently occurring. And hematomas were also less likely to occur. Most significantly, however, was the issue of lead dislocation and the need for re-intervention. And you can see at the lower volume centers, the risk of lead dislocation was more than two times higher than those at the higher volume centers. And so practice, practice, practice. The more you do, the better you will be. Pneumothorax, so let's talk about pneumothorax specifically. So we'll talk specifically about the history of endocardial lead replacement, because lead placement, that's because it's fun. So the first description of a transvenous lead being placed was in 1959. And that was actually through the right basilic vein here, can you imagine? And there was a high rate of lead dislodgement, as you could imagine. The second choice was the external jugular vein here. Cephalic cut down actually came next in the 1960s, but actually gave way later on with the advent of peel away sheets that allowed access to kind of like the bigger vessels and the medial subclavian approach which became very commonly used. You can imagine how that would be associated with a high risk of pneumothorax and hemothorax at a rate of one to 3%. And lead fracture also was a common issue. This is an example of a patient with a very medially positioned lead. You can see the turn of the first row here, which is typically what we target these days. And you can see that this lead has fractured. Those leads went through the costoclavicular ligaments or it could be crushed by the subclavian muscle itself. I had a patient who did a thousand pushups a day and he managed to crush his lead. So with all of those issues, new kind of approaches were sort of sought after. And in 1992, Bird kind of described the extra thoracic approach that many of us use today using the first rib as kind of a floor, a hard stop for our needle in getting access to the axillary subclavian vein. And then the use of venography was added to kind of improve the precision. And this extra thoracic approach was compared to the cephalic approach in this study in 2001. Here, patients were randomized to either the extra thoracic approach or the cephalic approach. I think the cephalic approach may not be very commonly used, but, and this may be a reason why, the greatest successful implant is about two thirds. The venous access time does take a little bit longer with sort of the cut down. The total procedural time is also longer. There is the advantage of no contrast and no entry into the thoracic space. But the estimated blood loss can also be substantially higher. And so for this reason, at least in our lab, our general approach is to use the extra thoracic subclavian vein approach first. As an alternative, use the cephalic approach. And in patients who are smaller, especially those of advanced age, we consider using a micropuncture needle. And then in infrequent cases, at least in our institution, use ultrasound guided access in these higher risk patients. So these next few questions are actually just sort of survey questions to kind of understand practice around the country. So how often do you find yourself performing venograms in your device procedures for lead implantation? So super interesting. So a full 43% of you use ultrasound routinely for getting access. That's interesting. Sometimes and rarely. I would say in our institution we tend towards rarely, but it seems to be becoming more and more of a technique that people are adopting. Actually, Susan, this one was venograms. Oh, I'm sorry. I'm sorry. Venograms. So, oh, routinely, sometimes rarely. OK, we almost always do a venogram. Thanks. Sorry. Thanks for clarifying. What about using the cephalic approach? I think people may have less practice with that. Okay, so I think that's probably, that seems to be the experience for most fellows. You know, for whatever it's worth, it's, I think it's worth asking your attendings in the right circumstance. You know, maybe there are 12 cases that day, but you know, I guess no one has 12 cases these days. But under the right circumstances, you know, see if there's an opportunity to practice the cephalic approach. It's a good, you know, kind of ace in the hole if there's some issue with getting, you know, axillary or subclavian access. Okay, and then the last one is how many use ultrasound for vascular access? Okay, so most are not using it, but it seems like there are some kind of using ultrasounds for lead implantation. That's interesting. Okay. All right, what about hematoma formation? So here's a question for you guys. We know that heparin is hemostasis, public enemy number one, sort of the John Dillinger of hemostasis. So what is a close second? There's a meta-analysis kind of looking at this. Uninterrupted anticoagulation, single antiplatelet therapy, or dual antiplatelet therapy? Okay. Great. All right. So the majority of you said dual antiplatelet therapy, and that is correct. So this is a meta-analysis looking at a few thousand patients, looking at what strategy was associated with the highest risk of bleeding, and here's the heparin bridging strategy. We all know that heparin is the enemy, whether unfractionated or using Lominox. Dual antiplatelet therapy is a very close second. Single antiplatelet therapy causes an increased risk of bleeding, and I think over time we've all become more comfortable with uninterrupted anticoagulation. Now that doesn't mean that if a patient has a low CHADS-VASc score that you wouldn't hold heparin for their device implant if you have the opportunity to do so, but we know that if patients have a high thromboembolic risk, continuing anticoagulation is reasonable to do, and these days there are enough data with warfarin for sure, and even with a NOACs it can be considered. The risk of major bleeding with the heparin bridging strategy and dual antiplatelet therapy in this meta-analysis was very similar, although the numbers were small, and there was no significant difference in terms of the risk of thromboembolic events, whether you continued heparin anticoagulation or anticoagulation was held. And so in terms of trying to avoid a hematoma, just think about whether or not ... I think we're all very ... we're so comfortable continuing anticoagulation, we almost don't think about stopping it, but if you can, for an elective device, definitely consider doing so. Antiplatelet therapy, if they're more than a year out from their stent, maybe you can hold their antiplatelets. Aim for an INR that's on the lower end if you can. In terms of technique, try to avoid disrupting the fascial plane, I'm sure we've all kind of dealt with that sort of bleeding muscle that's continually oozing throughout the procedure. Pay meticulous attention to hemostasis, and under kind of judicious circumstances, you can use pressure dressings to kind of help with hemostasis. Okay, what about the risk of infection? So this is an analysis of the Medicare ICD registry, including 200,000 patients implanted between 2006 and 2009. This looked at infection occurring within the short term, within six months, and it was very clear that dual chamber, that the addition of that lead led to an increased risk of infection, and that became statistically significant when compared to a single chamber implant for biventricular devices. As we all know, generator replacement, or any time you kind of re-enter a pre-existing pocket, there's going to be an increased risk of infection compared to the initial implant, and that was found to be statistically significant here. There was another study that just routinely swabbed pockets during generator changes, and found that 42% of these generator changes had demonstrated the presence of bacteria without manifest infection. Now, in some of those cases, that could have been introduction from the skin at the time that generator changed, but certainly some of it reflects the presence of bacteria just sort of lurking and waiting to cause problems. The six-month mortality was double that in patients with device infection versus those without, so it behooves us to do everything we can to avoid infection. So they performed a meta-analysis. We're familiar with the risk factors that increase the risk of infection. It's often multifactorial, but of these four, which posed the greatest risk for device infection, or which was associated with the highest risk of infection? Reducive warfarin, renal failure on hemodialysis, previous valvular surgery, or the need for acute re-intervention after the initial implant. And Susan, there was a question that came through about uninterrupted DOACs for device implant. How often do you do it? What kind of factors go into your decision-making on whether you want to do it? So it's a good question. I would say there aren't as much data to support that, although there are case reports that will support doing that. So if a patient with Tachybrady syndrome comes in with a long pause and needs an urgent device placed, then it's Friday, and it's a question of waiting over the weekend versus proceeding, uncomfortable proceeding. But collectively, I think because the DOACs are so short-acting, it's reasonable to just hold one or two doses and to proceed. In terms of when to start afterwards, the higher their CHADS VASc score, are they in AFib at the time, the shorter the duration of being off the DOAC, but usually at least a minimum of 48 hours. And then one other question, any data to support changing gloves during the implant or during long implants? Changing gloves? That's so interesting. I am actually not familiar with any data regarding that. I have an anecdote of an attendee who apparently changed his gloves routinely, like 12 times during device implants. I would recommend against that. But, I mean, unless there's sort of like a clean and dirty pocket situation, you know, I typically don't, I don't change gloves, and I'm not aware of any data. Okay. Great. Those are all great questions. So, all right, guys. So, yes. So, you hit on the two kind of most concerning factors, and indeed, it is acute re-intervention after the initial implant. And that was the factor that was associated with, you know, the highest odds ratio for developing an infection. And so, it just kind of drives home the point, the sort of, you know, the importance of avoiding, you know, sort of these complications in the first place, because then you add the layer of, you know, not only the risk of the kind of re-intervention, but, you know, there's the risk of device infection that goes substantially up. So, I think this valvular surgery actually is a substantial risk, in addition to any kind of re-implants that may not be acute per se. Renal failure, chronic lung disease, cerebrovascular disease, and certainly warfarin use were associated with a higher risk. I think we're all familiar with this chart showing which microbes are most responsible for device infection. Two-thirds are the coag-native staph species, and staph aureus is another two-thirds. We have our gram-natives here, and then sort of much less frequently fungal infections, you know, anaerobes, and then many times we come up sort of empty in terms of the microorganism. All right, so this is kind of a busy slide, and I should have animated it, but I didn't. But I think it's a nice summary of kind of best practices. Most of it does not, you know, was not supported by randomized controlled data, but, you know, certainly holds enough logic that the British Heart Rhythm Society came up with these recommendations in terms of preventing device infection. So certainly we know that pre-existing central venous catheters, whether it's a PICC line or temporary dialysis line, or a temporary transvenous pacing line, which we would have a little bit more control over, you know, poses a high risk of device infection. The patient has a slow rate, but it's stable. It's reasonable to try to avoid that temporary transvenous pacing lead if you can. There's no evidence for screening or empirically treating MRSA carriers, but if there's a known colonization, it's reasonable to treat. Continue warfarin in high risk patients. Again, hold antiplatelets or anticoagulation in others if you can. Patients are recommended to bathe or shower with soap prior to the procedure. We actually send patients home with these chlorhexidine scrubs to use the night before or the morning of the procedure. If they're inpatients, we also order these scrubs to be performed. You want to minimize the time that the device and the surgical equipment itself is left uncovered. If there's some delay in the patient coming into the room and the table's already been open, you know, we'll place a sterile drape over it. During upgrades, I always take an antibiotic soap sponge and, you know, cover any sort of equipment that's going to be exposed for a long period of time. So, non-slippers and not razors should be used to avoid microabrasion and introduction of bacteria. 2% chlorhexidine has actually been compared in a randomized fashion to iodine, and it's clearly associated with a lower risk of infection, so that's preferable. It should be left on for at least 30 seconds. So part of the effect of this scrub is the mechanical scrub, but there is a minimum amount of time that's required for the chlorhexidine to have its maximal effect. IV antimicrobials have also been studied in a randomized controlled fashion, clearly probably the strongest benefit of anything we do. It should be given within an hour prior to making that incision. Ideally, the infusion's complete within 20 minutes. There's no data for repeat dosing after skin closure, although that's not uncommon for people to do. And as we all know, beta-lactams are superior to vancomycin, to the point that, you know, especially for an elective procedure, it's very much worth sending these patients to allergy to debunk their, you know, childhood allergy to penicillin, which oftentimes can be proven not to be a true allergy. And then finally, a second slide on best practices, the local sort of, you know, irrigation with antibiotic solution is not proven. I think we all do it. Capsulectomy was actually looked at in a randomized controlled fashion. In 258 patients, there was a higher rate of hematoma, which if you've ever tried to do a capsulectomy, you'll understand why. The rate of superficial infection and mortality was no different. So it's not recommended routinely, but certainly for patients who have a deep pocket infection, you want to get all of that tissue out. And the British Medical, or the Heart Rhythm Society had no specific recommendations about wound closure. Just, you know, to drive home the point, avoid other complications in the first place. And certainly patients who've been hospitalized for a long period of time have a higher risk of infection. And those patients will kind of double dose with both beta-lectins and vancomycin. What about pouches? So that was a big question mark for a long period of time, and now we have some data to look at. There's the RAPID trial, including 7,000 patients who were randomized. First published in 2019 for 12-month data, and they just published actually their 36-month data earlier this year. And included pocket revision patients, patients who are undergoing replacement or upgrade or a new multi-lead device, and they were randomized to either antimicrobial pouch versus none. The primary endpoint was infection resulting in extraction or revision, the need for long-term suppressive antibiotics or death, and the secondary endpoint was procedure-related or system-related complications, meaning, you know, does the addition of that bulky pouch, would that add to problems with the pocket or erosion or pocket discomfort? And what they found ultimately was that actually the primary endpoint was met. There was a statistically significantly lower risk of major CIED infection. It was actually primarily driven by a lower rate of pocket infection. Vector anemia or endocarditis occurred at a similar rate, although those numbers were quite low. And that significance and difference, you know, bore out at 12 months, and with the newer sort of 36-month data, the hazard ratio remained statistically significantly different at 0.64. Interestingly, looking at sort of subgroups, it was clear that the benefit was driven by patients who were undergoing some kind of high-energy replacement or upgrade, and they seem to drive the majority of that benefit. And so given sort of the cost of the pouches, which can be substantial, and the number needed to treat being about 77 patients in the rapid trial, our group, I think, in general, will not use it for all of these patients, but will use it sort of more selectively in these patients undergoing kind of high-energy device upgrade or replacement. Okay, what about perforation or tamponade? So, well, it turns out it happens. This is a patient of mine from last fall, who you can see has a substantial amount of fluid around his heart here. So just for your viewing pleasure while we review this slide, this is one study looking at 3,000 patients, 26 patients of whom had cardiac perforation. There was a predominance of female sex. Symptoms occurred in 72% of patients, with thoracic pain being the leading symptom that people reported. The time to perforation in general was short at 3.5 days, but even very late perforations could be seen to occur. Most of the perforations occurred in the right ventricle, all of them through the apex. 88% of these were active fixation leads, and 15% were right atrial leads causing the perforation. Effusion was seen in about 60%, and about one-third of those required, like my patient, required drainage of their effusion. One patient out of these 26 ended up also having a pneumothorax. Here's an example of how that might happen. That lead can go through and through and actually enter the lung cavity. The most common finding in terms of lead parameters is a high threshold. Suddenly, the lead is no longer in good contact with the myocardium. You can get abnormal sensing where suddenly your sensing comes down, and in about a quarter of patients, diaphragm stem can be seen. Interestingly, with these, especially with acute perforations, those leads can actually just be withdrawn. In the vast majority of these patients, in 25 out of 26 patients, those leads can simply be withdrawn, and the lovely, forgiving right-sided myocardium will simply just contract and seal off that little hole you tried to make in the myocardium. In one case, a patient ended up having kind of worsening tympanod and required an urgent thoracotomy. It's not unreasonable, especially if the leads look not to be totally through and through, to consider withdrawing these just in the EP lab. All right. That was minimizing device complications. Sorry. Do you mind? There were a few questions about device stuff before we go on. A lot of questions about infectious stuff, interestingly. One was, when you do a generator change, do you avoid the old incision, or are you comfortable just incising directly over the old incision? Well, it's a good question. I mean, there is sort of a theoretical issue of less vascularity in that scar tissue and potentially an increased risk of poor wound healing. I have to say, I'm not aware of any device that argues against doing that. I've done these procedures with plastic surgeons, and I suppose the weight of the advice of a few plastic surgeons may not be enormous, but I tend to go through the old incision and have had reasonable outcomes and have not seen data to indicate otherwise. And then there was a question about post-procedure prophylaxis for antibiotic use five to seven days after implant. So that has been looked at. I don't have that in my slides, but there is no benefit to five to seven days of antibiotics compared to just the pre-procedural antibiotic instilled within that one hour, 20 minutes before the incision is made. There's not even evidence for antibiotics after 24 hours, though I would say there's certainly a robust practice of doing that. But five to seven days, unless there's an active device infection, there's definitely not evidence for a benefit there. There was a question about if you have someone who has an indwelling device who's going for another procedure, is there any need to think about antibiotic use for the other procedure, PCI or ablation? It's a dialysis catheter placement, but I assume IR is giving antibiotics in that situation. That's a good question. So I think physiologically, our thought is that after three months, the leads should be well endothelialized and the pocket should be encapsulated so that the risk of bacteria sticking to that hardware is going to be on the low end. So kind of routine antibiotic prophylaxis is not routinely recommended in those cases. It's not included in the routine endocarditis prophylaxis, for example. I've had patients who had some dental emergency a week or two after their acute implant, and for those patients, I will give them prophylaxis. But if it's outside that three-month window, it's not routine practice to give antibiotic prophylaxis before other procedures. And then a couple of questions about micropuncture. Is there any data that there's actually reduced risk of pneumothorax with the micropuncture? And what about using the micropuncture for a closed cephalic access rather than a full cut down? I'm not familiar with that technique, but it sounds intriguing. As far as use of micropuncture and risk of vascular damage or pneumothorax, I'm not aware of any data, but I haven't looked. I'll be perfectly honest. I will say that I did mention it in sort of older patients. I think theoretically, you're probably less likely or you're more likely to create a small hole versus a large hole, which is the rationale for using it in those kind of higher risk situations. That's great. I think that pretty much covered it. Okay, great. Great question. Okay. All right. So that was devices. We'll talk about minimizing ablation complications. And I have given versions of this talk maybe for seven or eight years now. And I will say that this is like the one area in which practice has really changed for the better. So this is just kind of a very busy slide looking at contemporary rates of complications in some recent ablation studies. And the types of complications were counted differently. And so the numbers are kind of a little bit all over the place. But the point of this slide is just to point out that vascular complications in sort of these studies in this era made up a reasonable portion of these kind of overall complications. But I think over time, we're going to see that change with the routine use of ultrasound. So, you know, I think a lot of times because we have the ultrasound, it's very tempting to just grab the ultrasound, take your picture, smush the vein, and, you know, go in. You know, in addition to doing that, I think it's useful to like have in your head this picture and, you know, have in your mind what exactly you're targeting. And your goal is to really hit the sweet spot, you know, of the femoral vein within the femoral triangle. And so what I would encourage you to do is to step one, always take the patient's, you know, foot and or knee and, you know, externally rotate so that you're kind of frog legging or at least kind of splaying out and opening up, you know, that space, the femoral triangle. Oftentimes, you can see the femoral artery on top of the vein. And if you kind of externally rotate, you can bring those a little bit more separated from each other. The next step is to palpate the anatomical landmarks. You really, you know, should know when you're putting that ultrasound probe down, you know, where the inguinal ligament is, where that should kind of be in your mind as you're getting access. You want to palpate the anterior superior iliac spine and the pubic symphysis, understanding that the inguinal ligament is going to kind of run in between those. And your goal ultimately is to, you know, to avoid puncturing too high. We know that the vein is, you know, kind of following the pelvic floor and so is not going to be compressible beyond the inguinal ligament and cause retroperitoneal bleeding. We also don't want to stick too low. We'll start running into the femoral arterial branches, causing a higher risk of AV fistula. And we also want to avoid the superficial saphenous vein. So here's another picture. This is sort of the sweet spot in terms of the femoral artery and kind of, you know, understanding that the bifurcation is going to be on the lower end. And the bifurcation is also a guide in terms of, you know, where to stick the femoral vein. Typically that's going to be on the lower end of the femoral triangle and you're going to want to stick the vein a little bit higher. And keep the saphenous vein in view or out of view to kind of avoid hitting it. Understand where that is. So the real game-changer has been ultrasound. I don't think I made a question for this in terms of who's using ultrasound or not. I think most people are these days. I would say, you know, seven or eight years ago it wasn't 100% for sure. But this is a meta-analysis of studies looking at the use of ultrasound versus not. This is one randomized controlled trial. The rest are just, you know, sort of observational studies. And it's clear that, you know, there's a substantially lower risk of complications to the tune of a risk ratio of 0.29% of major vascular complications. And that includes all these categories of, you know, inadvertent arterial puncture, you know, groin pain. And there's a reduced, you know, kind of access time. The success rate is also higher with the ultrasound, sort of real-time ultrasound-guided approach. And when, you know, 3,000 of these patients were looked at, those patients undergoing pulmonary vein isolation where, you know, sticking the vessel cleanly is, you know, even more important, you know, similarly there was a radically reduced risk ratio with ultrasound. So I think we're all kind of familiar with the technique. These slides are just to point out that standard 18-gauge needles oftentimes are not well visualized directly. You can sort of indirectly see it sort of displacing the soft tissue and then maybe tenting the vessel. But if you have, you know, if you can use a micropuncture needle, the tip shows up as a very kind of bright, you know, ultrasonic signal here. And you can see it sitting right on top of the vein here. The next step is to look for it tenting the vessel without impinging on the artery at all. And then finally kind of seeing it pop through into the main body of the lumen. All right, so that's been a real game-changer. What about minimizing the risk of perforation and tamponade during catheter ablation? So these are kind of older data but seem to be fairly consistent with kind of recent complication rates. Maybe these rates are a little bit less than 1% these days with contact force information. In the first contact force study looking at contact force versus non-contact force, there was a 2.48% incidence of perforation. That was probably a function of this being sort of, you know, early use of the stiffer catheter. But what was useful out of that study was that there was a trend toward a greater percentage time in higher contact force, meaning greater than or equal to 40 grams. So, you know, I think generally speaking, we try not to, you know, surpass 30 grams on a routine basis. You know, if you're spending time in the 40s, you know, you're sort of looking for trouble. This was a study looking at perforation force in vitro in swine and human cardiac tissue. A smaller catheter size, you know, required reduced force to perforate. And then the minimum force required to perforate the tissue was 38 grams. So again, kind of, you know, staying below 30 grams is probably ideal. You know, less than, you know, kind of 25 is even better. So what are the strategies to avoid perforation? Don't push too hard. You know, steam pops are more likely to cause perforation if the force is higher versus less high. You know, another point of potential perforation is at the time of transeptal puncture. I think we're becoming more and more comfortable with kind of performing that with less fluoro. You know, as we do that, we want to be very comfortable with our ice fuse and take advantage of, you know, our 3D mapping options in terms of understanding the anatomy at that time. Don't push too hard. And I would say the most important piece of perforation management is recognizing it early. So, you know, no one wants to have caused a perforation and, you know, your heart sinks into your gut and your blood turns cold when, you know, whoever is watching the blood pressure tells you, you know, the pressure is getting a little soft. But the most important thing is to just, you know, keep it in mind and, you know, look at that LAO view, look with your eyes. And, you know, if you recognize it early and you treat it early, it can be managed in a reasonable fashion. The enemy of complication management is denial. And this can happen. It's human nature. And the important thing is to just run towards those possibilities and to recognize it and treat it early. Okay, finally, the last issue is minimizing the risk of stroke. You know, over 10 years ago, it was recognized that uninterrupted warfarin was a very reasonable approach for not only reducing the risk of stroke during AF oblation, but, you know, not necessarily seeing an increased risk of bleeding during the procedures. This is an older study looking at sort of INR ranges and the incidence of complication. It's interesting because the vast majority of these bars are made up of growing hematomas and vascular complications, which are probably, you know, a lot lower in this era of ultrasound guided access. Nevertheless, there's probably going to be a similar trend. And the point of this slide is just to show you that there is kind of this sweet spot between 2 and 2.5 with the INR, and that clopidogrel makes a substantial difference in terms of, you know, the risk of bleeding. What about uninterrupted NOACs? We now have a substantial body of data supporting that use with these studies and this meta-analysis, which was showing that there was either a trend or statistically significantly lower risk of complication for major bleeding, tamponade, and composite outcomes in NOAC versus uninterrupted. And this informed the 2017 HRS guidelines on the use of anticoagulation peri-procedurally. The use of uninterrupted dabigatran and riboroxaban got class one indications, while uninterrupted other NOACs got a two-way indication. Also, the approach of holding one or two doses prior to the procedure received a 2A indication. And this is one study that looked at, you know, outcomes comparing those sort of uninterrupted single-dose skipped versus 24-hour skipped, showing that there was no significant differences in terms of major bleeding, though there were, you know, few events overall. All right, so those are kind of the nuts and bolts of trying to minimize complications. Sorry, before you go on, because this next part is obviously very important, but there was one question. Have you ever seen a significant RP bleed with just venous access? With just venous access. Um, I feel like the answer is probably, I don't know, that's a good question. In the era of ultrasound guided access, the answer is no, just because I think we're so much more precise about, you know, kind of where we're sticking versus like blindly sticking very deeply. Yeah, I can think of one, and it was non-ultrasound access, and it was at a point where people weren't comfortable doing the procedures on warfarin and were bridging, and that's the only one I can think of. Okay, so I think in the modern era, that risk is probably, you know, extremely low, extremely low, and more to do with technique versus, you know, venous versus arterial access. Okay, good. So, here are my last two slides. So, these are about just sort of like discussing complications with patients, how to approach it, because it can be difficult and, you know, awkward and scary, and so in my 10 plus years of being in practice, I've had to do this more than just a few times, and what I've learned is that, you know, just start out by being frank, just be frank and be clear, don't obfuscate, don't try to, you know, skate around it, deny it, you know, just be clear, this thing happened, you know, the lead went through the heart muscle, and there's, you know, blood that's leaking around the heart, and just be very frank, be very clear. You know, give the patients a roadmap about what to expect. So, because this has happened, you know, we're going to perform these tests, you know, what are the possible interventions that may occur, you know, there is going to be surveillance follow up, this is how often we're going to see you, this is what we're going to be looking for, and, you know, give them a sense of what the possible outcomes are. What are the possible outcomes with my patient who, you know, had the perforation are that, you know, will drain this effusion, you know, the lead was functioning just fine, and that we'll be able to leave it in place, and, you know, that will be kind of the end of it long term, there's a small chance that later down the line there will be a lead problem, in which case we'll have to move it then. Make sure to include family, you know, if there are loved ones there, again, it just, it's just, it's embarrassing, you know, it's mortifying to have caused a complication, and so I think as humans, our first impulse is to, is to try to hide, or just, you know, hide from it, hide from the family, hide from the patient, you know, and you just have to not do that. You know, make sure the patient and the family know that you are with them, you know, on this journey of, you know, recovering from this complication, you want to stay in close contact with them, and I say this specifically because there are circumstances in which, you know, physicians don't, you know, stay in close contact with their patients, and, you know, take the direction of moving, you know, away from the patient, and not advocating for them, you know, throughout the process. I kind of surveyed a bunch of slightly more gray hair than I am electrophysiologists about what advice would you give fellows about how to approach a complication, and I think, you know, the most concise advice that I heard was to just own it, you know. I think it's just very tempting to kind of, like, deny anything's happening, or to just minimize what's happening, but it's just important to just own it. It's okay to express contrition, you know, I suppose lawyers might tell you something different, but, you know, I mean, your patient is a human being, you're a human being, for me, I find it, you know, useful for them and for me to tell them how I feel, which is that I'm sorry that this happened, and it's okay to say that. Do not abandon your patients. Make sure yourself, make yourself readily available to them. I give my cell phone number to these patients so that they can feel that they have a lifeline, you know, at a moment's notice. So this is the last slide. So, again, try to resist denial, you know, at the time that it's happening, you know, after it's happened. Acknowledging a complication can be difficult, but that denial can delay recognition of the complication and appropriate treatment, and you're always going to be better off treating early than later. Resist the urge to ignore bad news. The only, you know, worst thing than bad news is bad news that isn't addressed right away. And, again, I'll just, because it's so important, I'll say it again, do not abandon your patient. Be sure they understand that you're as concerned as they are about what they're going through. And then, finally, I think it's really important, you know, I suppose there might be some superhuman people out there who are not adversely affected by such events. I'm not one of those people. So acknowledge to yourself that this is difficult for you. You know, you will go through feelings of guilt, you know, for having, you know, I mean, at your hands, your decision-making causing this issue, questioning your own skill and judgment. You know, there's fear of litigation. All those things are feelings that you may have. Maybe you won't have them. Great. You know, but if you do have them, that's very normal. The most important, these are, like, really negative feelings that can very much, like, eat away at you. And it's so important to get it out and not just let it kind of fester. So it's important to discuss with a trusted colleague. I've told Ms. Shawn about all my interesting things that have happened. I feel fortunate to have, you know, those colleagues around. Talk with, you know, your mentors. It's also important to discuss with your family and friends if they can be a source of maybe not, like, medical advice, but emotional support. And then just know that all proceduralists experience procedural complications. We've all had them, and we've all gone through kind of these same feelings. And I think the most important thing, you'll go through those stages, and it will be hard, you know, but get it out in the open. Talk to people about it. And in the end, learn from that experience and just be better. And part of, you know, the reason I talk to all of my colleagues about, you know, adverse things that have happened is that, you know, I'm hoping that maybe it's like a little nugget that, you know, will be useful to them in the future. So anyway, that's it. Thanks for listening. Thanks, Susan. That was great. And I agree. I think that last part is so incredibly important for everyone here, every trainee, and does make a big difference how you handle these. There were a few other questions, which I think I'll let you field. So the one was about using heparin during chest venous access cases. So SVT ablations, etc. Do you routinely use heparin? And post-procedure, do you give aspirin? Yeah, that's a great question. So once access has been obtained, then yes, we give heparin, or I give heparin during SVT procedures. So typically, you know, I give 3000 of heparin at the beginning of the procedure, I give 1000 every hour. And if they're very small, or much older, sometimes I'll just give 2000 instead of 3000. For left-sided procedures, if it's, you know, just like a pathway, without extensive ablation, I will give a full dose of aspirin for a month. You know, based on purely sort of anecdotal data, young women, if they're smokers on oral contraceptive pills, I will also, even if it's a right-sided ablation, give them a full aspirin for a month afterwards. And then there was a question about afib ablation. Do you routinely give protamine afterwards? And, you know, do you do them uninterrupted on DOACs? And if someone missed a dose, when do you restart the DOAC after the procedure? So, I typically do hold the DOAC prior to the procedure. We'll hold it, you know, 24 hours beforehand. Although, again, there are, you know, plenty of data showing that you can give it uninterrupted, although some of those protocols would, you know, divide the briboroxaban to 10 in the morning and 10 after the procedure, or decrease the apixaban to two and a half on the day of the procedure. So, there are all sorts of nuances in terms of, you know, sort of how the micromanagement around the procedure, but, you know, there's enough data to support kind of holding, you know, the one or two doses prior to the procedure. And then if they've missed a dose, well, we ask them to miss a dose, so that doesn't make a difference in terms of our practice. And we typically do give protamine to reverse heparin at the end of the procedure. And then, I think this is Melissa Robinson, makes a very good point. One of the more difficult aspects of complication avoidance is M&M and tracking complications. Any advice for fellows coming out of practice, because some hospitals don't routinely support that? That's a really good question. I mean, I've only been at academic centers that kind of require that. And so, I suppose if you are out in practice and it's not required, I think it is incredibly useful to keep track of sort of, you know, the numbers and types of procedures that you're doing, and to somehow try to keep track of those numbers. I know that our lab has the ability to pull those, you know, numbers of procedures up. And so, maybe, you know, as a practitioner, you don't need to keep track of your number of procedures, but to keep a log of your complications, and then you can get your denominator when needed to make that calculation. And if anyone has any other advice, you know, in terms of doing that or experience, feel free to weigh in. Yeah, I think that's good advice and stuff that we've told our fellows when they're coming out to try and initiate it if they can. But I will tell you that there has been some pushback at places about talking about complications. You know, that is a good point, and I was kind of trying to decide how much to talk about it, but there is a whole kind of risk management, you know, risk management aspect of, you know, complications. There are, I mean, it probably is reasonable to talk with your institution about their, you know, kind of approach to managing conversations, you know, in terms of complications. You know, I have had many conversations with risk management at Northwestern, and, you know, I feel like they take a very kind of open approach and, you know, feel that the best policy is for the physicians to, you know, express, you know, their feelings about what has, you know, transpired. Feel contrite, express contrition, you know, it's not wrong to apologize, you know, but there is, you know, some risk management issues or risk management sort of strategies, I suppose, that doesn't sound like a great word, but risk management issues to consider, you know, in terms of managing all that. But I will tell you that, you know, you know, risk management starts with the moment that you meet your patient, you know, if your patient feels like you know them, and you understand them, and you care about them, and, you know, if something occurs that you continue to care about them, and that you're interested in their well-being, it's kind of, you know, incredible how much, you know, room your patients will give you to be a hero. To be a human being and to, you know, not be perfect, and to just go on that journey with you.

complications

electrophysiology

EP procedures

pacemaker implantation

lead complications

ablation procedures

ultrasound-guided access

anticoagulation

family involvement