Dr. Erich Kiehl with Sentara Cardiology Specialists discusses guidelines for cardiovascular implantable electronic device lead management and extraction techniques.
I'm gonna try and make this a shorter talk. I know a lot of people are out of town this week for spring break with their kids for those of you who decided to call in from spring break. Um thanks for doing so I hope you're having a good week off for those of you that are here um both in person and and over webex. This is really designed to be a talk um about lead extraction in general conceptually and then functionally what we've done here uh in the past presently and what we plan to do in the future. So my first slide uh usually don't spend a lot of time on the title slide, but but in this case I'm going to actually, so um you know, I trained the Cleveland clinic with with matt and um I think sometimes when people come from Cleveland clinic, you find that you just compare how other places do it compared to how you did in fellowship probably to a fault sometimes. And I think there are some things that Cleveland clinic does really well and some things that probably they do a good job of marketing more than actual equality. Um lead extraction is clearly an example of, of an area where Cleveland clinic does things exceedingly well for pretty much the entire time, lead extraction has been a specialty. It's been by far the highest volume center in the United States in the world. Um it's a very robust program, uh showing basically how you can do this procedure safely and efficiently. And so when I came in 2019, my goal was to try and bring at least the best parts of what Cleveland clinic does from a protocol perspective to here. And I think hopefully by the end of the talk you'll realize that we've started to do that and it really, I think a good way still have room to grow and I think will grow significantly over the next over the next year. Um but but that's why this slide looks like that. Um Mhm. This is my disclosure slide, find that it's growing daily, which is make a good thing actually in the grand scheme of things. Um what you have here is both disclosures in terms of what I get compensation for. Uh and then what I do research with um the research disclosures uh do not come with any direct funding to me. Um What you will note is that I do get paid by phillips as a consultant, which is our primary extraction vendor. There are two major extraction vendors in the United States phillips and cook. Medical Medical does primarily mechanical sheets, whereas phillips uses both laser and mechanical. And so most people in the United States use phillips as their primary as their primary modality, but some of the slides you'll see through here and I'll try and point out which ones those are were in some ways develop uh five phillips um for other talks that I've given. So I'll just kind of point out anything that's a little bit more marketing so that you know that that's the case. So just a quick quality disclaimer and just an opportunity for me to share a cute picture of my daughter. Um Normally I spend a lot of time when I give talks and trying to piece together a thematic talk um and go kind of even if I have talks on them before kind of start from the beginning and go Uh from slide 12 slide 50 or whatever I get to. This is a talk that I kind of Hodgepodge together from six other talks they've given over the last year. Um And so there may be a little bit of disjointed nous hopefully you guys don't feel that way. I'm gonna blame my daughter for that because when you get four or five hours of sleep a night holding a baby, it doesn't leave a lot of time for anything else other than working, you gotta six week old tomorrow. Um So what is the lead extraction starting in very general terms. So I think most people know that elite extraction is taking lead out uh implantable trans venous leads. Okay? But the definition of elite extraction is actually an important thing because when you look at metrics and you look at numbers, not every lead extraction is considered the same. Um So basically elite extraction procedure just distilling down this HRS paper. Uh This is a guideline document which is actually if anyone has more interest in this other than what we're going to present today. This is probably one of the best guideline documents to read because it's only like 20 pages and actually every single reference is pretty high yield. Um So elite extraction procedure is basically if the lead is if a lead is more than one year old regardless of how you get it out it's a lead extraction. So that could be You just unscrew the helix and you pull back with your hands. That's the lead extraction. If it's 366 days old, 364 days old and you do that. It's not a legal distraction. If on the other hand the lead is three days old, this would be rare but the lead is three days old and for some reason won't come out that way. And you have to use specialized tools, locking dialect mechanical, she's um laser, she's mechanical extraction tools. It is considered an extraction. So an extraction is defined by either the presence of a lead more than one year old or the presence of the need for mechanical extraction tools. Um When you look through some of the data, I'll show later for our both Cleveland clinic and then for here um just complete procedural success rate and clinical success defined somewhat differently. Um What I'm going to show you is complete procedural success with a lot of the day, you'll find externally you leave fragments less than four cm as long as they're not back to remake. It's still considered to be a successful procedure. Um from my perspective, maybe it's just being a perfectionist. I don't consider that to be a success. I don't look at that metric. Um and when we look at just for definitions of indications for extraction. So non functional leads are basically leads that aren't working abandoned leads or leads that were left behind for some reason. Usually they were upgraded and they didn't extract at that time. So I think one of the things that the pet peeve of mine is in this institution, we historically have said, okay, well doing laser leads. Okay, so um what that does is shows that as an institution I think historically we haven't acknowledged that there are other ways to get leads out. So we should really be using the term trans venous lee distraction, not laser lead extraction because frankly I only use laser about 50% of the time. There's a lot of other ways to get leads out that might be safer and more efficient for patients. So when we talk about mechanical tools, the laser on the left is what the glide light laser same, the same machine that we use for calf procedures as well. But the sheets themselves are different. So there 1214 and 16 French sheets that deliver laser the tip and they have an outer sheet got mouse control but they've got an outer sheet on the end that you can use the mechanical break up tissue in addition to actual laser sheet on the right, you'll see the long version of the tight rail and the short version of the tight rail sub C. These are mechanical sheets that's probably hard to project but there's actually like a rotary burr cutter essentially that that rotates when you deploy this um or basically this plunger here on the end of the, on the end of the machine. And I'm gonna show you basically examples of both. It is what they look like for and why you might use one versus the other. I haven't really mined idea that well to see which ones I use actually use both of them a lot because they're they're better in different regions from a safety perspective. So um I thought rather than kind of talking about extraction for 20 minutes and boring a bunch of you, I'd start with some videos. Um and when I was making this talk I just happened to see something on Facebook about like you know the tv card you used to have when you're in elementary school and how like I'm not sure what our kids do now. They just have big screens but when it's movie day do they roll in this big screen and they see. So I'm just going to start with some videos. Um Just some disclaimers about the videos. So they're just cases that are recorded in the last two weeks. And if I had thought more about it I probably would have recorded more cases to get better ones. These are probably not the best examples. Uh These are only pacemaker leads. The I. C. D. Leads are a little bit more interesting to show kind of lead extraction techniques because there's more high caliber width of material to get around in these cases. I don't have that. The other thing is that uh you'll see one of the first extraction to show you is a little bit jumpy jumpy and frankly it looks a little bit violent. It's not normally the way it works but it was a passive lead and it's just the way it came out. So um just take everything I show you with a bit of a grain of salt. I'm gonna show you two cases. One is a case from last Tuesday which is a lady who had complete heart block and atrial lead fracture and therefore was basically not synchronous anymore had pacemaker syndrome. Um And um Had 21 year old uh 21 year old passive pacing leads. The second case I'll show you is I think From two Tuesdays ago the gentleman who I think seven year old pacing leads and I was included but needed an upgrade to a C. R. T. V. So this is the video is a little jumpy but this is basically the laser sheet over the atrial lead on that first case and what you can see is that the black tip is a tip going in and then around it it's gonna stall for a second and it'll restart. Um you can kind of see maybe faintly, there's gonna be an outer sheet that kind of gets outside of it. That's that black teflon outer sheet that was showing you on a photo before. What we're trying to do is is get through, get through basically all the way down the lead. And what you can see is I can't really make it past this point. This particular patient when I opened up their pocket, they had a ton of calcium is very brittle and calcium doesn't get broken up by laser in this situation as well as uh as a mechanical sheet works. And so when we see a lot of calcium and you can kind of almost appreciate maybe there's a little bit haziness there on the floor. A Skopje, if we zoomed in more um this is a good candidate to move uh from a laser extraction tool to mechanical extraction tool. So um what I my approach is generally if I'm taking both leads out, it's going to be lead lead adhesions, so I'm gonna go on the lead. I think it's gonna be easiest to try and get it out of there and if it won't get out then I'm gonna switch to the other lead with the same tool. If I meet the same resistance, I'm either going to up size because there may be just debris. I'm not getting around or if I feel like I'm just not making progress, I may want to switch from a different modality to another one. So what I chose to do after trying the same thing on the ventricular lead and not getting past the same point, they switched to the mechanical sheets. It looks very different on ferrous copy. I don't have the outer sheets on this one for a variety of reasons. But you can see I'm making. So yeah, I told you this looks a little bit jumpy compared to other ones. Usually it's nice, nice and smooth, a little, a little bit jumpy to the next one. So here's with the ventricular lead and you can see we're making our way down pretty easily. Uh and then when it gets probably about the mid part of the tea out, it comes. So normally it doesn't jump like that. But the passage leads, they can stretch quite a bit. And that's why you see that. I just play this again real quickly. If it allows me. But I want to show you I have extreme tension. See how this lead is getting pulled. So the number one rule with extraction is that if you want to have a terror, you want to tear the heart. You don't want to tear the sbc and that's why pacing leads aren't the best examples to show you because of the fact that the s if you have an Sbc coil, it's going to be stuck at the sGC and pull as hard as this. But when we, when you do training for extraction, actually, it's a rule that you have to go on a simulator and they measure your tension versus your pressure and they want a pretty negative delta on pulling. You don't want to pull so much that you're inverting the heart, but you want to pull it off the lateral wall. The sbc because the worst thing you can do is not have enough tension and basically push the sheet through the lateral wall, the FCC. And I'll show you an example of that. So, um this is the second case and these are some pictures of us actually prepping the lead. I know that the lighting is such, that you have no idea what I'm doing here, but this is kind of from beginning to end. We're actually prepping the lead. The first thing that was done is basically one of the surgical assistants was holding a scalpel up that I was running in between my hands, basically cut off the insulation. And now we're actually cutting the lead to expose all the lead elements. The next thing we're doing here is we're putting a locking Gillette into lead and I'll show you what this looks like in Flora's copy in a second what the purposes of it are, but basically it's just long, really thin. Um I let that allows us to lock to the tip of the lead and we can see and Flora Skopje where that is. This is probably the most important part of the procedure because if you can't get your lock and sell it all the way down, uh it really limits your ability to control the lead two, what you can see here is this little black thing that is going back and forth in the lead. What I do is I go all the way to the end, will I meet resistance and I go on philosophy and I pull back to make sure I'm actually at the end of lead and then I re advance it. So once I get it to here I lock it and what this is essentially doing is locking to right here. Whereas the normal side lets you put in for a lead, they're not they're not locked in any way, you can remove them very easily. So what this allows me to do is basically pull on the tip of the lead when I'm pulling on the outside of the of the style it and the concept of this is if you try and write with a pen, you're not gonna write from the eraser, you're gonna right from the tip of the pen, you're gonna have much more control that that's the concept here. So once we've done this, what we then do is we tied all the parts of the of the lead. Now this is not an I. C. D. Lead. It's a pacing lead. So we're pacing we're tying non observable future to the insulation that's remained. So I'm not basically pushing the insulation in it and pulling the lead out and then I'm going to type back to the end of the locking. Sell it where it has a little loop. It's basically just a bunch of hitch knots. Like if you go camping and you wanna um basically tie tent up and you know put a tarp over it. Um If you had an I. C. D. You would also basically cut the lead and there's high voltage elements to the coil and you tie those in a knot and then tie the knot to that And tie those back to this. And now you have an I. C. D. Lead. You're pulling everything all the same tension, you have a pacing lead, you're pulling everything all the same tension. This is me then putting the laser sheet on the uh on the pilot and then frankly almost dropping it. It's kind of uh you'll see in a second. All right. All right so uh save the $3,000 piece of equipment and then um getting it all situated um and ready to extract. So this is me getting ready to extract. And this is actually a pretty good example of what not to do. So um you can see in this angle mike's got a pretty good shot of it, you'll see the sheet kind of buckle near the skin surface and that just shows you're not transmitting your force the way you want to. And then I actually have a floor images of why that was the case. It's not anything from a procedural for technical issue with this patient in in general. See that buckle right there, you're you're pushing in, it's not transmitting the force. So if I wanted to transmit the force more regularly, I would have been pulling harder. But the reason I didn't want to do that in this patient is they had an occlusion. So if I pulled the lead out back past the inclusion, I can't re implant. And so these are situations when you have pacing leaves, even when they're seven years old, but sometimes you choose not to unscrew the active helix. You want to try and leave the lead in and give yourself enough body that you can actually get past the inclusion. And despite the fact this is seven years old, you can almost kind of imagine, but you saw on the outside the body, the cheese is just kind of buckling. I'm trying not to pull and all of a sudden you see the a league pop free. So now I don't have anything to hold onto. So if I just pull back the lead is gonna come out, that's not gonna be a way that I can retain access to re implant. So I've still got the ventricular lead and I'm gonna try again on the V. Lead. I'm going to do the same thing here and unfortunately you're gonna see the same thing happen. So I'm just trying not to pull too hard for me to come out. I left the helix exposed and still it pops out now. The only way that I can retain access, do this left side and do a CRT upgraded to actually hear the lead. So what we do now is from the femoral vein, we put a lasso scenario interaction and grab one of the leads and pull down really hard to provide that tension as though the lead was still attached to allow us to laser over it. This is hi Staring is a lot harder than it looks and so rather than show you the five minutes of me flogging to get this over there. This is the, you know the 10 seconds where it worked. I know sometimes they're harder. Yeah, sometimes the bigger snares are actually harder. So right now you can see I'm pulling tension out and then pulling the lead down the problem with staring with with leeds is the helix oftentimes it hits the helix and flips it off so it's just it's just kind of a pain in the butt. Once you get it snared though. Now you can see I'm pulling down and it's clearly off off the sbc and I'm able to get the sheath in. It's still relatively hard compared to normal. And you can see there's some really good adhesion between the laser and the neutral lead and give it another five seconds, we'll see it kind of popped through. But this is how we're able to retain access right about here, you'll see it pop through. And again, it's just constant pulling back and then traction, counter traction to the outer sheets and the inner sheets. And also the entire time. I know a lot of the time there, I'm actually just using mechanical pulling back, but I am raising a little bit. So now I'm clearly passed the inclusion which in this case was kind of in this region that advantage to going down and trying to balloon it first or anything. How often your your did you ever think about running a balloon down there and just blowing it or? Well, has that been done? Yes, but this is, this is usually very, very easy to do. And when you have an inclusion that breaks for you like this, the likelihood of unitarians, um it's more just getting a good snare to pull on. Um So now you can see us pull the even take the lead out, we basically release the snare pull the lead out and now we have our lumen. And so that now we have a lumen, we can put a wire down in this case We put three wooly wires down. That's not going to show you three wooly wires to save some time. And then once that wooly wires down this is me pulling the sheets back out um retaining the wires there, put a little pressure down and then pulling the other lead out. Now we're onto the re implantation. The other thing you'll see is Little plastic things here. These are basically figure of eight ties that we're going to lead to leave. We can shut them down and reduce the risk of blood loss during the procedure they're taking, you know, 16 French sheets out of the vein, back and forth, back and forth. You can lose a fair amount of blood if you're not careful. So this is the end result at the end of this case that created to see our tv in a in a more elio view. So indications for extraction and a broad sensor infection uh for functional leads but reasons of usually inclusion or some other reasons kind of in more detail and then nonfunctional lead. The lead fractures, inflation breaks. This is a reality that as an externalized coil. So the question is, how often do trans venous leads cause problems? Well, um this is a paper I wrote when I was a fellow uh talking a little bit more about leaderless pacing. This is actually when the initial ST jude leave. This pacemaker was coming out and then it ended up getting recalled. But infection, you'll see lots of different numbers and I'll show you show you some of the next couple of slides, um infections has about a 3% risk over the first generator. When I did my own research and this is probably four or five years ago now, but greater than 10% after a generator change. But most gps will tell you the procedure that I hate doing the most is jen change because it's all risk Venus occlusion. As you saw an example of 14% by six months, 26% by device, you'd be surprised how quickly venus occlusion can occur. I mean it's it's crazy lead malfunction in terms of the fracture impedance warnings. Uh these increased with age, certainly there are some leads that are likely to have problems and others regatta Fidelis are the ones that are most kind of notorious about this. And then obviously in our structural heart colleagues see this all the time. Tr is a huge issue with leads and I think why you're gonna see leave the spacing become really the future for or facing in the next 5 to 10 years. So interestingly these are two slides, these are slides that were provided to me by uh not slides but figures from phillips. One interesting thing basically this, this slide on the left is showing the growing rate of device implants, ironically, this, this then shows the implant rate being rising but somewhat fixed. So these are kind of desperate numbers. But what you can see is that the risk of infection with implants compared to implant rates changing has gone up dramatically. Why is that? It's probably a variety of reasons why that is. We're probably putting devices in secret patients, patients are living longer, there's more diabetes in the US figure risk infection. Um there's probably a lot of different things and probably maybe our surgical techniques. That is it should be. Um, we've known this for a long time pacemaker vs. I. C. D. I. C. D. S have more issues with infection. More leads you put in. This also comes to abandoning leads and the reasons to extract leaves. If you're if you're making an upgrade, uh, CRT has more risk of infection. This is a study I think out of Duke that showed Overall rates of infection 6.2% of 15 years, 11.7%. At 25 years in the more pockets into the public. Whether it's hematoma evacuation generator change, Um, that the risk of infection can can actually get as close as 25%. So, these are the indications for extraction from an infectious perspective. So if you have definitive system infections, that could be a pocket infection back to re mia with a clear vegetation and a lead of class one indication for extraction if you have valvular endocarditis, let's say you have already found endocarditis from staff and you have a lead in place, The lead looks fine. The lead by definition infected. So you take the lead out and and the battery. Um for patients who have resisted persistent factory mia despite appropriate antibiotic therapy, whether it's gram positive or gram negative. Um and we'll get to that uh delineation here in a second. Um Also a class one indication for for extraction and then don't forget about the epic cardia leads. Actually cardio leads need to be taken out to if there's any evidence of pocket infection. This is an example actually of a case that I extracted. I think maybe the first year I was here. And you can see kind of the dusky nature of this pocket patient had pus coming out. This is after I had evacuated the pus. This is the capsule that we took out and this is the muscle underneath. You clearly see there's a huge difference in the infection here. These I think are extremely high yield, not just for ep but for general cardiology, for infectious disease, for uh for hospital medicine. Uh documents from the HRS guideline and basically how would you work through who needs to have devices and extracted? So if you suspect that somebody has a device infection, you get idea involved and you get blood cultures. If you have positive blood cultures, you get a t obviously want to make sure it's not just leave, it's not, you know, endocarditis if you have a valve vegetation uh and they have a lead like I just said it gets to come out regardless of the type of bacteria. So you basically remove the lead antibiotics. Obviously if they need to have their valve taken out that should really should have been put in here as well. But if they have a vegetation on the lead nothing on the valve. Again the duration depends a little bit on I. D. Rex. But you take take the system out they have a negative T. E. And this is you'll see the slide on the next one and they have Grand positive factory that you would still probably take the lead out and then the re implantation Usually it's about 72 hours is the minimum. You should wait if they're not dependent the longer you can wait the better. So you don't have to just keep them in the hospital and re implant in 72 hours. You can think creatively about how to re implant. If they have negative blood cultures they have pocket erosion. The device comes out negative blood cultures negative t. Just close observation. So this is I think the most important slides of all the slides in there. So basically if you have back to re mia without source of infection. So no no pocket infection. No lead uh issues on T. E. But you have staph aureus quite negative staff Canada the device comes out if they have pretty much the other grand positive strep and enter caucus you're probably going to take the device out if it's gram negative it's probably not device related unless you have a pocket there or a clear vegetation on the lead and so you're just gonna observe their so the bacteria matters. So despite all these class one indications uh this is this is a late breaker at A. Cc. This year. Um We are. Abjectly failing. So this was a Medicare uh database review uh run extremely well from the group out of Duke whose high volume extracting center and they reviewed nearly 1.1 million patients of which they identified roughly 12,000 infections. You may know that that infection rate is lower than what I just showed you. But Um even though that number was lower of those 12,000 patients nearly 82% of them did not get extracted. And their one year mortality based on claims data was nearly 33 of the remaining uh roughly 504,000 patients that got extracted. It depended how quickly they were detected and got extracted. So if they got extracted within six days their mortality was still high it was 18.5%. But if they got them within 7 to 30 days it was 23% I'm gonna show you some other slides that show a similar finding at a large and U. C. S. D. Where actually the mortality difference were significantly different. So even though we had indications for patients to have extraction Uh 4- five patients are getting missed. And so why is that the case will kind of get to that in a second. But sometimes people just try and manage it medically and they say okay well just give antibiotics and we'll open up the pocket, wash it out and go back. It just doesn't work. So this is this is this is one of those slides that said I was gonna when it was provided to me by phillips that I used for another talk. It's a nicely sighted and effective Slide. But basically what you can see is patients with infection partial system removal or antibiotics. And they're relapse rates. They're all over 50% where the extract they're all less than five. And this this has mortality implications. As we just showed this is that study out of U. C. S. D. I was talking about where they basically looked at early versus delayed lead extraction. They defined it the same way which is why I think you defined it the same way which is less than seven days. And that has been our protocol here that the way we timed our extractions is so that we can get within actually our goal is three days. But um at a minimum we can get in within seven days. And what it showed. Panel A is factory mia. Panel B is pocket infection. What you could see was a statistically significant difference in mortality. This is not Factory Me a recurrence. This is actually survival differences. And you can see the huge gap that pertains to Factory MiA at one year. Mhm. This is some of the data as to why we would remove A. And this is quoted in the guidelines why you would remove system that for staff factory MiA without evidence of infection on T. E. Or pocket infection. Um and basically there's a 35% 1 year mortality for these patients. If you remove They're ICDs 72% relative risk reduction in mortality. That works out to almost a 10% absolute risk reduction. If you think about that. The number needed to treat then it's 10, the number needed to treat for hypothermia after cardiac arrest. So um and this is mortality as an endpoint. It's actually very striking figure. Um So this is more for the E. P. S. Who are calling in. So a lot of people have asked, what do you do about these patients after you extract them? What what kind of systems you put in and particularly their dependent you put in a uh temporary attempt term which is basically screwed only like we would put in for tavern and just let them clear the infection. That's what we primarily do. There's a lot of emerging data actually that Micra pacing has much lower risk of infection for a variety of reasons. Think it probably has to do more than capsule ation similar to watchmen and uh and micro clips and things like that. Um But uh Emery is probably the world leader on this and they basically use micro as a virgin strategy and a lot of patients and if if the pacing strategy is reasonable as a long term strategy and these are three studies published in different journals. Not super high powered journals but um you know J. C. And Pace are kind of mid mid level E. P. Journals. And the pool in on these three studies is about 100 and none of them have shown infections on people that basically had micros placed in during active factory. Me at the time of extraction. I've done this a couple of times for patients that were kind of um Really just not good candidates for 10/s. They were occluded or something like that. We could probably consider using this more going forward. The problem with micro so quickly blow through these. But these are the non infectious indications for extraction and then I have my own little commentary on the bottom that paul and matt I'm sure could time in on. But uh so if you have spc stenosis or occlusion then you need to put a new lead in, take a lead probably as many leads out as you can and sometimes in those situations the question earlier you would you would have asked their balloon something or intervention balloons something to try and give you some therapeutic benefit. If you had symptomatic swelling, you have pain at the site. Um you can take the lead in the system out. Don't do that that often. Your prophylactically worried about sbc um syndrome or occlusion down the road. They already have four leads on one side or five leads total. You can extract is to minimize the risk of that long term. If there is a recall lead to Rihanna Fidel as everyone has a different political on these. Um if you're at the time of a generator change and you know, these leads may go bad over time. Uh it's reasonable to take leads out at the time to try and prevent the need for feature extraction when the leaves are older and therefore harder to get out. Um, M. R. I. Is less of an issue, although sometimes still do this. Um A little bit behind the times in our M. R. I. Protocol here, but there's enough other centers around the area. You being one of them that if we need to get an M. R. I. And an M. R. I. Incompatible lead, we could send a patient. Uh So I don't do this that often, but I have done it a couple of times. This is not in the guidelines now, but I find that for busted valve intervention, it's probably going to be a bigger one going forward. I think probably structural heart sent to me, I don't know four or five patients that we've extracted for severe tr to facilitate uh subsequent try custom valve intervention, ironically some of those patients actually got better in their tr went away. That is not the experience that we expect to see. Um Usually when the lead has been in there it actually either gets worse or stays the same. But I do think we're gonna see that this is a bigger intervention going forward. And hopefully in the future if we put more legal systems in it won't be a problem. Yeah, we're seeing about 80% of our patients with severe tr referred to have right sided leads, 80% right? And so it's it's clearly a problem. I mean um I'm actually doing telehealth on the patients that you guys are looking for to eliminate on Wednesday. So this is why I think we missed so many patients. I think there's this fear that all cases end up like this. This is a case I was actually involved in. I will say that I was not the one doing the extraction but compared to the other one, remember when you saw how much lead was getting pulled to see how this one's getting pushed. Um This is a really complicated patient, remember the story but I think this is when I was a general fellow with probably the leading extractor in the United States. So this wasn't just it just happens sometimes, but this is this is a T. E. For this case 10 seconds after this picture shows how much, how quickly the blood can accumulate in the tarot card. And I think there's a stigma. The lead extraction if you have a complication results in death and that it happens a lot and there's been very interesting um Hold that each of us conferences in the past or the tail cable, guess what the lead extraction complication rate is. This among amongst gps and oftentimes as though it's 5% 10% 25%. This is again a Philips slide. So I take some take some uh grain of salt with this. The lead extraction is probably accurate this from the electric on trial where they looked at major adverse events and they looked at it Basically broken down by vascular complications which is 1.1%. And the need for transfusion is the other .3 which from elite extraction perspective is no longer considered a major adverse event. And compares it to other procedures. I don't know where they're getting the Pc. I. Data from or the Taber data. These numbers seem high to me for the other ones. I think what's important is to say that the lead extraction number is not 1%. And so not to say that it's less risky than P. T. I. Or tavern. Those numbers seem high but it's more it's more, yeah they're really high right? But but the point is that the point is that the lead extraction numbers are not as high as I think people think they are and I think people don't get referred for a variety of reasons. But I think one of them is this fear that if you send your patient your patient. So how do we reduce that number? How do you do? Um This is a bridge inclusion balloon that we deployed in high risk patients in the sec and their guidelines as to who we put them in basically. This shows that we are injecting contrast from, you know, and that klein you're completely including flow. What you basically do is you pre stages and you figure out how many ccs it takes to inflate the balloon where you position it. You basically have it all marked out so that if you care as the floor, I was going away and the surgeon is coming in, you have a wire already up there, you can put the bullet up and inflate it and it can can save quite a bit of blood loss. This is a large mod database review that roger Carrillo out of Miami has probably. He and Bruce Wolkoff are probably the two biggest extractors in the US in terms of names um had they looked at 100 and 16 confirmed sec events. This is basically phillips to generate the data for them. And they looked to see who who had proper bridge balloon uh bridge balloon use, who had either basically oh we have it in the room. Let's get it up quickly as there is a terror. They didn't have it in the room. They looked at survival 88% of patients survived at the bridge, 57% without the bridge. So how do we improve access to care? Uh You know, I think um I think you know to the point of the fear, I think we have to say okay you can't really be afraid of the company if you're afraid of complications as procedures, you probably shouldn't do that. I think you have to know um what you would do if a complication occurs. So you have a good protocol. And I think Winston Churchill quote is really is really the more important one that he who plans to fail and fail to plan is planning to fail. So we plan for everything that could possibly go wrong with each patient and we're ready to act. And so sure your poultry probably goes up a little bit but probably not as much. And then I think and this is an H. R. S. Uh recommendation, I'm sure not a lot of people do it because it's somewhat cumbersome but you have to have your own internal data and when patients ask you what your rates are, you should know them. So that's what we do here. And that's what Cleveland clinic is. Not a very good job of not show me the money and show me the data uh being a michigan homer. I'll just say the other thing you have to do is you have to have a good team. And so it's the same as quote of saying you know anything you do you have to see how is it going to affect my team. And I think if you look at this as I'm the operator, I'm the physician, you've lost lead extraction does not work unless you have everyone on board and that so from a systematic perspective that means that you have buy in from your administrators in your means that you have a good working relationship with your surgeons and you understand and the surgeon understands that if I have a problem this is where it's going to be. And you have good communication about how we're going to rescue that patient. Um you have to have a team that is cross train both from an ep perspective and from a surgical perspective we have the patients in the room and then that starts from before the patient ever comes to the time the procedure is over. So you know we get referrals from other E. P. S. We get referrals from our device clinic we get referrals from our cardiology colleagues that are not electro physiologists. We get referrals from structural heart as we talked about. We get referrals from C. T. S. We get referrals from I. D. From the hospital service and actually and we'll talk a little bit more about the CMR can be a pretty big referral that we haven't put into play yet because of bandwidth issues. Um Sometimes you'll need two operators to do a staircase. You need more than more than two sets of hands. The text, the nurses, the device reps whether you cook or phillips for your extraction. That the research is really important. This team in the room from a surgical perspective you should have a ct surgeon on site C. T. Anesthesia running T. V. For you. Your surgical assistants are hugely helpful uh scrub text from the perspective and perfusion in the room. So if you have any of these elements that's missing you can't do this. Um And that's that's why it's important. So we talked about you know preparing for complications. Um They're the frustrating part about extraction is there's never really been a great uh because the rate thankfully is so low. It's a little bit like a festival. It's hard to predict who's going to be a pair. You can predict what cases are going to be long by ct. But what's really helpful just to look at large retrospective databases is a picture of it was my mentor at Cleveland clinic. This is probably the best Study which is basically looking at 20 years of data and saying these are people that we think are higher risk. So females be my differences like everything end stage renal disease, dual coil leaves etcetera etcetera. And so we can use those to say this person's higher risk and therefore we want to use different tools. This is a bit of a busy flight and it's more just for me to remember what I wanted to say as opposed for you to read it. But basically the way we go through things is pre procedure. We look at each lead piece of lead information. Is it recalled? What is the lead age? Is it a passive or inactive lead? What what data is there on that lead in terms of extraction, what does the X ray looks like? Is it pretty lateral in the sec? Is it media in the sbc and there's lots of good data, a lot of it coming from deep Patel will be joining us in august looking at the use of cT and how that can help plan. So it gives you a better idea of really good adhesion of course to the sbc mobile scene, resolve those cts for us and does a great job doing it. Um We use the hybrid O. R. For most of our cases that we'll get a little bit more data on how that's changing. We try and huddle before the procedure at least um an ideal world altogether. Sometimes it's not worthwhile to say okay if we have a terror, we're gonna do a median anatomy rescuer or right to our economy if it's been an oldster anatomy based on the patient's body habits, what lines do we want? We need a neckline. Do we need a growing line for resuscitation? Obviously we're using a bridge balloon here. Do we want to put in place holder? Accesses for ECMO if we need it? Um We probably overuse the bridge balloon. Um I've never really had anyone come back to me and say we're spending too much money on that one. I think it's just a safety blanket. It's helpful thing to do. Um We used to eat. So we know when things are happening in real time. We use arterial line, we have blood in the room, we have profusion and cps in the room and we make sure that cts, if they're not in the room, something else is going on out there on the floor. There's a difference between having cts in the room, having them in clinic and having them be home should not be doing lead extraction if the surgeon's knot there because five minutes at least it's gonna take for them to get there is gonna be too long. So this is my experience and we're kind of exposing up here. Um Yeah, we're doing on time. Um yeah, we got 20 minutes. So um my experience in fellowship is that I had the good fortune of training, as I said before, easily the highest volume. Center in the United States. And I had the good fortune of training with Bruce Volkoff was kind of like the godfather of lead extraction and then um Dave martin who's who's a bit of a nutty professor but there's actually an excellent extraction is done right and it's really good at allowing fellow autonomy. I didn't do as many cases as you would think I maybe have done before I came but I did enough case, enough hard cases to know that I knew I was doing So. This is five years worth of Cleveland clinic data from some of the time that I was there from 2013 to 2017 basically that on average 200 Systems per year and on average about two leaders, 2000 leads and just keep those numbers in the back of your head when I show you some of our own numbers in a second and they had a 98% complete success rates. That's removing everything. Not at four millimeter four centimeter mark. That I said that I professional supplies that just don't, I think that's a reasonable thing to look at. Less than 1% of patients needed emergency surgery And they had 0.4% deaths over that time period. So again, showing that this isn't as unsafe as the procedures. I think the stigmas would tell you otherwise. So before I came in 2019 this was um this is primarily a cT surgery driven program um this way way preceded me coming. But it used to be that the cases were done in the E. P. Lab and from what I've been told and there's more here say there are a couple of cases that went terribly wrong in the E. P. Lab and so cases removed to the hybrid for a variety of reasons when that happened he kind of got out of extraction and ct surgery took over. And I will say for those of those of ct surgery is online they actually did a wonderful job because most ct surgeons are not both ct surgeons are not don't have a love for extraction. Um uh you know I think dr barrera and dr Philpott are both actually pretty excellent extractors in their own right. Um And I learned something from dr Philpott that I didn't learn from Dr will cough that I that I do now And they were doing pretty reasonable volumes. They were doing about 20 cases a year in 2018 and 2019 That 50% of those cases were infections. And it shows that people weren't referring patients for non infection reasons. They're kind of coming in in patient they were getting done and that's probably a little bit of an outside out of mind thing by not having ep actively involved in extraction. Um But those volumes were still in the mid range in the mid atlantic. So um We were still kind of a 50th%ile site but for whatever everything else that we did where were you know near the top of the state, if not the top of the country, it was out of proportion to the number of patients that are in this region. This is what's happened in the three years, 2.5 years that I've been here. So when I came in 2019 and this is actually, but I've told people who are interested in going into extraction fellows education through Philip, it's really important when you're deciding where you want to work. It's important to have discussions early on about extraction. That's something you want to do because it can be a little bit politically tricky And you really have to form that team and everyone buying in your strategy. So I have had talks with John Philpot um really from the time that I interviewed and I think it was 20 18, Maybe early 2019 and we had kept an open dialogue and when I got here that this is gonna be part of my job and so like we're gonna do with our new colleagues coming in the fall the first Last quarter of 2019 we did all of our cases together so we co scrubbed about 10 cases and then they kind of said, you know, you're pretty you're pretty fine at this. If you want to do this you can take over. So in 2020 then COVID hits but despite that we double our volume in 2020. Um and we figure out one of the tricks and how you build uh lead extraction. It's kind of silly but I. C. D. S. You can coast surgery build but pacers you can't. So we kinda came up with this thing where we alternated to build and um finally uh and this is where administration comes into play. What we've done a really good job of putting in metrics and the surgeons contracts for quality. Just like we have our metrics that backing up E. T. Is is part of their quality metrics as I understand it. And so I think it's been a better system for everyone. People are happier with it into the volume doubles to 45. Our wait times got so long that in 2020 they actually gave us pretty much every other Tuesday for outpatient cases and then an urgent spot um at the end of the day on Fridays after matt finishes his tavern For impatience. And despite that our wait times are still long but our volume again double to 92 systems. What's most important is if you look in the middle column you'll see on the pipe starts and now infections only 25% of our cases not the infections went down actually went up. It went from 10 to 2023 over a one year period. But it's the other things that were being more proactive about and this is just this is a number pulled from phillips that's kind of mid year where they're just showing blinded is that's our number versus everyone else in Virginia were dwarfing the competition now. So what's happened regionally is when I came riverside was doing a little bit um Ryan Suter was doing a little bit I think as well they may still be doing some but I think it's it's a procedure if you don't do a lot of you don't feel super comfortable with. And I think people felt comfortable just sending patients to me. And so we have a pretty large referral network now. Um During covid there were some issues in our lab was closed that I sent some patients. Hopkins and Hopkins had some issues that they sent to me. So I have a pretty good relationship with chuck, love from Hopkins. Got some referral from Baltimore from D. C. Lot from north Carolina. Several have gotten referred from Lynchburg and actually from a group over there. Um and so the referral network is growing pretty significantly and telehealth has become a huge part of that. The weird thing I meet most of my patients the day of the procedure for lead extraction, it's a little uncomfortable at first but I feel like we've talked enough with myself, my nurse Suzanne by the time we get there. I feel like any other patient quite well. Okay so how do we grow this program went through some of the logistics. You know the question, a lot of people I think would have when they see these numbers like oh you're just extracting a lot of easy leads. Uh No the answer is no. So these are three um systems that we have actually extracted. Um And you can see this one has five leads. This one has It's uh four or 5 leads including multiple I. C. D. Leads, passive leads. This is a really really old system has one tunnel from the right and some from the left. This one's all right sided. As to see athletes, they don't really know why but uh and then and then an elite in an RV leads. So lots of abandoned leads. So We've extracted 269 systems since I've been here 305 leads totally. Nearly 2500 lead years Mean patient age is 65. We've been extracted an 18 year old and a nine year old And the nine year old was quite spry and factory Mick. Uh main case lead age was 15 years, the maximum which is this one here was 79. Um and so if you look from year to year in 2022 average lead case age was 13 years and 2021 went up to 15 and this year's at 17 and after today's cases will go even higher. 50% of our cases our I. C. D. Leads at which 50% are dual coil three D. 33% are leads greater than or equal to 10 years old which are considered to be old leads and leads greater than 20 years are considered to be very old. And I think that in the last check was about 8%. 12% have abandoned leads. So remember those numbers from before that I said Cleveland clinic success rate was 98%. So mine's 97% 83%. Of the time we've required power tools so I don't want to use the term Laser lead extraction 17% of time I needed nothing. And of those 83% probably 50% or laser. Um We've had one vascular injury which happened in the phenomenon it was actually on this case um in hindsight looking through things I learned a little bit about that case. Probably there is no way around getting around a terror and we didn't really have another good option so I can sleep a little bit better at night about that. Having looked through the case that patient was discharged alive. He had some neurologic issues but we've had no procedural related mortalities directly from from the procedure. Uh and so again the Cleveland clinic numbers are 97 98 or 97 complication rates are pretty similar granted. You know the numbers are smaller so it takes another end of one or two for those numbers look much different but for right now I think we're tracking from a success rate where we need to be. So where do we go in the future. So um right now the wait time to get in to see me for an extraction is still about three months. Um And a lot of patients can't wait. So unfortunately my gonna do a fair amount of uh schedule juggling to try and make this work. We lean a lot on our P. A. S. For which I'm very thankful. Um And um we try and uh try and get as many patients done as we can. I will say that this does not work without the extreme help and support of dr newton from surgery and then from the structural heart team because we're using a limited resource in the hybrid and it's just trying to make it make it worth work with limited staffing issues you know from time to time. So what I'd like to do and I think they know this is my ask in april right now staffing issues are going to include that in May um And then make a little bit more flexible on Thursdays and Fridays for an add on case for infection. The reason for that again is too we have cases on Tuesday and thursday and friday there'll never be a person in the hospital would have to wait more than three days theoretically for a lead extraction. That's what the data shows improved mortality from early extraction. So of all the data I showed you I've done the vast majority of those extractions over the last three years there are very few people in the US at this point that do that many leads per year. It's a lot for one person. I do other things that I like to do like cbc ablation ablation and watching and things like that. So we need help. Um And and I will say dr Barreiro who's kind of our our lingering um cardiac surgeon who does extraction has been helpful and we when when when needed. But we we're hiring two E. P. S that are both starting in mid august from Cleveland clinic will both come with good extraction experience. Patel and the right has done a lot of research on lead extraction as well. He was one of the lead authors on a major randomized control trial about basically calcification in the pocket and on C. T. And a predictor for for lead extraction success. So I think the program is only going to grow in a good way. I'm not here. I'm on vacation, patients won't have to wait and we don't have to just switch around schedules of one operator. We've been trying to be smart about utilizing a hybrid. And so I'm very proactive about analyzing my own data. And it turns out that a lot of pacing leaves just like the one I showed you that fell out will come out without needing mechanical tools. And so if somebody is not included and we feel that they're low risk. We can do them in the lab and this has been agreed upon by Epp and surgery. So right now if your if your leads are more than five years or less than five years old and they're pacing leads only or it's a single coil I. C. D. Lead that's less than one year old will do them in the E. P. Lab. We did do a five year old I. C. D. Lead and a seven year old pacing system in the E. P. Lab last week. Just because of issues with with scheduling in the future. Uh We're hopefully in time going to rebuild lab one with larger detector which will make it easier for us to see the whole system when we're extracting this kind of a limitation right now and it will work with ct anesthesia and surgery to try and take more cases to the E. P. Lab to try and offload the hybrid a little bit more. Um you've been working on how can we become more efficient utilizing MAC and patients where we don't think we'll need uh to use a lot of extraction tools to try and avoid T. E. S. And those patients to just kind of minimize the risk of the procedure and prove the speed of the procedure. Um We've actually sent some extractions home the same day and I plan on publishing this data here in the next couple of years, patients that have required minimal power extraction probably don't need to spend the night in the morning cases. We watch them for enough hours. We've had no issues with patients coming back with bleeding or any issues. I alluded to this earlier. But um there are EMR flags so not that you need more alerts and epic I feel like it buzzes at you all the time and gives you red flags. But basically there's there's an infection system where we can put into place that if somebody has a defibrillator or pacemaker and they're back to remake it'll flag and basically say like you should consult the p a lot of places like Duke use this. We just don't have the band with my wait wait times already three months right now we don't have enough operators to do this. But once we're fully up and up and running and have the staffing that fully planning on implementing that and that's going to increase our volumes. I think over time probably where we're gonna end up somewhere between 120 575 lead systems per year. Should put us pretty close to Cleveland clinic honestly. And I think the only large extraction center if you look at data for the size of Hampton roads that's about right. Um From a research perspective we are participating in a mid atlantic real world extraction registry. It took a long time to get through the I. R. B. But we're partnering with atrium health johns Hopkins U. D. A. And are going to try and publish data. Most of the data just comes out of Cleveland clinic and so we're going to try and partner what the real world looks like and I think it could become a very prolific research possibility for us unfortunately. Um You know, we've, we've kind of gotten noticed nationally, so um I've been invited to go to the Miami lead symposium which is where the guidelines come from, that will be in 2023. I co chaired with chuck love in january that the national fellow symposium at Hopkins on lead extraction and then fellow education, we're doing a little bit of that HRS that came from volume and from knowing people too, I wouldn't, I wouldn't discount that part of things. It's nice knowing Bruce walk off in a variety of things like that, but um what I would say and this is a plug, not just for lead extraction for a program in general, um I think we need to do a better job of publicizing what we do. So I think in a small space like lead extraction there, you know, there aren't that many companies people know about you pretty quickly. Um you know, we do a great job here with structural heart with ablation with chip. Um we should probably try and publish our outcomes and our data better. I've had conversations with Ashford I mean and nova does a good job of doing this actually got they sent their like annual report last night I was opening and reading it I was cooking dinner we do three times as much watchman as they do. We do twice as many lead extraction. We do um more more ablation than they do with less labs. Um And I think our outcomes are better but not a lot of people I think know that outside of the region nationally and I think we could leverage that in a better way. So we've done that with extraction we're gonna do that further. Um we've been approached about doing physician training just like structural does doing some live cases. And I think the thing I'm most excited about is there's a new tool coming out called Guardian that everyone's been excited about for about 3-4 years. Um And they're releasing it to five physicians in the U. S. Starting in Everything's projected correctly Q2 of next year and then we're one of the five that got selected so it's gonna be a combo laser mechanical sheets. You can just toggle back and forth. Um So I'll end with that. Sorry I said I wasn't gonna go long and then I only left five minutes for questions but hopefully um most questions were answered already so I'll turn things back over to you rob. Eric thank you. That was that was a great presentation
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