Chapters Transcript Video Updates in Leadless CIED Technology Dr. Erich Kiehl describes transvenous lead systems and cost of CIED complications. Wanted to start by thanking Div for inviting me to give this talk. Um, this is a, uh, I, I, I struggle with the title a little bit. It's, uh, updates and leadless CIED technology and clearly I have the EBMS logo, uh, going over the Y so it looks like I don't know how to spell this morning, um, but. Um, this is gonna be primarily focused on dual chamber, uh, of your lead list, but I did kinda wanna spend some time going through kind of the evolution of lead list technology and, uh, both in the defibrillator and the, uh, non-defibrillator space. So, um, just kind of as a brief starter so you can kind of see on the screen. Alright, so, so this is an atrial leadless pacemaker and a ventricular lead this, uh, pacemaker. They're two separate units, um, and so I, I enjoyed when this first came out kind of reading the radiology reports on what this was. I've seen a couple times that comment on a bullet or something like that, but, um, but, but these are actually the pacemakers here. Um, these are my disclosures and, uh, conflicts of interest. I won't go through them all in great detail, but I do think some of them are pertinent to today's talk. So from a, from a CRM perspective, I'm on the NextGen tech advisory board for Medtronic, uh, so what that means is I actually am privy to some of their new designs for Leless pacemakers that are coming that I can't talk about in this talk, but, um, we'll kind of allude to potential future directions in a non, uh. In a legally binding way I would guess I should say um. Uh, a lot of this talk will focus on the dual chamber of year which is an Abbott product. Um, I have done some research with, uh, Abbott in, uh, both the ablation space and then, uh, pertinently the, um. Device space in in terms of CRT on the SINAV trial uh but I don't receive any consulting income from Abbott. Um, I do also receive some consulting income from, uh, Phillips, uh, and I will talk a little bit about extraction in here. So those are probably the pertinent, um. The pertinent things before I get into the slide I just wanted to say um. Just kind of as a as a as a public service announcement uh it's very difficult to fill grand rounds talks in the morning um you know we're all very busy clinically as as physicians um and so I think we have a pretty open May slate um sometimes it can be a little bit, uh, daunting to come up and give a talk to 100 people online and you know 50 people in the room and feel like maybe I'm not an expert in this in this uh in this space. Um, but the reality is we are all experts in in some degree, uh, in whatever space we think, and, and everyone else can learn from each other, so I would just, uh, encourage anyone who is interested in giving grand rounds to reach out to Div or Amy, um, we're about 2/3 of the way through the academic year, um, and just trying to fill out the schedule so we can give education once uh once a week. Alright, on to the slides. OK, so. These are kind of 3 of the problems with trans venous leads and systems. It's a bunch more than just 3 problems, but on the on the left this is an infected pocket from a device that I took out, I think about 5-6 years ago. This is a, uh, venous occlusion, so somebody was trying to get an upgrade to say a CRT or an ICD and you can see that there's uh a flush occlusion of the vein here with the collaterals forming around it. And then this is uh one of the recall leads you can see the the the wire is basically going straight out through the insulation of the lead um so so these are kind of when I give talks to fellows, uh, about the needs for lead extraction these are three of the reasons why we extract, but you know there's there's other, you know, other things that can arise MRI and compatibility, um. Lead associated tricuspid regurgitation which I'll talk about in a little while and so the point here is that when we talk about traditional pacemakers and defibrillators that leads themselves are very much not benign things. So, um, I'm gonna try and do my best to not name drop this entire talk, but in this space, uh, two of my mentors kind of have a huge role in, in kind of pushing this technology. So this is Dan Canelon who gave grand rounds and was at the um. Uh, uh, Mid-Atlantic symposium we do once a year. Uh, this is one of his papers, uh, where they looked at complications and and health care costs associated with, uh, trans venous cardiac pacemakers and what you can see in the dark black line here, so I took my laser pointer away. Uh, here we go. The dark black line here, what you can see is kind of composite complications over time and just keep in mind that this is only 36 months, so 3 years out, about 15% of patients have some sort of complication that leads to healthcare costs associated with uh trans venous systems. If you look at the the sub breakdown, so, um, you know, pertinently this kind of grayish dotted line, the second one here is infection, and so at 3 years, 5% chance of infection says 1 in 20, um, and that usually requires complete system removal, um, and so you know 1 in 5 or sorry uh 1 in, you know, 6ish patients is requiring something at at 3 months. That's a pretty significant number. Um, and the costs of, of CID related complications are actually quite staggering, um. OK, so this is kind of a busy slide, but what you can see, I'll just kind of focus on the high points here. So if you have an infection with commercial insurance, uh, the cost of this is about, well this is predicted cost, but the, the mean total cost could be as high as $120,000 that's all comers for infection pockets maybe slightly less than bacteremia. If you have a lead complication requiring revision that could be an atrial lead dislodgement that requires a repeat procedure 40,000. Um, perforation which obviously could occur with nonlethalist technology to 130,000, and that's for commercial insurance, obviously the numbers in terms of what's paid and what the cost is for for Medicare and Medicaid are are different, but, uh, these are staggering costs if you think about, um, you know, the health care system and and trying to come up with a way to make the balance sheet work. So What's the solution? Well, I don't think there's a solution per se, but, uh, the idea of leadless pacemakers, which isn't a particularly new one, is a way of potentially reducing the complications of having leads. So these are two of the original um. Kind of gen one leadless pacemakers. The one on top was called uh NanoStem, which was the Ave precursor from Abbott. You can kind of see compared to the size of a dime how small we're talking. This is one of the first generations of micro, which is the Medtronic lead this pacemaker compared to a nickel, um, and this is just a picture from an old review paper I wrote. It's, it's crazy to say this, but almost 10 years ago when I was a fellow. I'm just kind of reviewing uh early generation leadless technology. As I said, they're not that new. I mean, if we think about, you know, we're giving this updates and leave this technology in 20 in 2025 and if you look at the dates on these paper 2015, 2016, so these, these are now a decade old, um. And these are papers both from New England Journal. Um, this paper here is the nano stem, uh, trial, and again, again, not trying to name job too much, but again you're gonna see the same people driving the space so Dan Canon's on this paper and the micro space, um, you can see this one has a slightly different fixation mechanism that we'll go through, which is a timed approach whereas this is a uh uh a uh a helix approach where you basically kind of similarly to a trans venous lead, um, we'll fixate the, the system into the myocardium. Uh, it's important you can, I don't know if it can show super well on, on this, sorry, the laser pointer is being weird. Here we go. OK, so on this right here you can see kind of the anode cathode relationship. So some people will say, well, maybe Leless technology is different because you know you're getting the helix or the tines in differently, but the actual active part is further back the cathodes right here, it's not actually the spring, so that's important to to kind of keep in mind as we go through. Um, a couple of comments about these two gen 1 devices, so, um. These were both released and then nano stem was pulled off the market, um, not right away but relatively quickly due to battery depletion uh issues. To their credit, Abbott did a fair amount of work kind of figuring out what this was, reconfiguring the device, making it better. And the process of the recall allowed us to learn a lot about extractability of this device, um, which, uh, which we'll go through in some detail later to understand that the current generation device of VR is is probably a very safe and effective device for long term kind of retractability uh and extractability, um. In the micro study and we'll go through complications in a little while as we talked about complications related to trans venous systems as part of their initial uh landmark study what they did is they used a historical cohort where they said, OK, these are the complications associated with trans venous leads in the micro cohort, um, they saw a 50% reduction right off the bat with the first generation device which is which is quite remarkable. OK, so. So here's some actual complication data again this is from uh Dan Canelon's work um and you'll see Vivere, he's on a bunch of these studies too as it seems he is with all EP technology but. This is basically looking at leadless implants versus trans venous implants again, historical cohorts because it wasn't a randomized control trial and showing a marked, uh, reduction in complications and quick diversion of the KM curves, um. You know, at, uh, um, I believe this is at uh 540 days, so basically 2 years, so you've got freedom from complications of about, you know. 85% here versus 95% here so 10% absolute risk reduction at two years with leadless pacemakers and if you say OK well. Which patients do better? I, I, I actually cut off the other part of this graph just to put it in the slide because none of the whether its age, gender, history of Afib, coronary disease, diabetes, tricuspid valve disease, peripheral arterial disease Leas pacemakers had less complications across the board. And they, I, I'm not gonna go through this in great detail, but this looked at short term complications, so less than one month, and they showed, uh, 5.8%, uh, for, uh, leadless pacemakers versus 9.4% for um, uh, for traditional trans venous pacemakers largely driven by lead dislodgements and things like that midterm though, which are the ones that come with bigger costs like infection, need for lead revision. Um, and this is from 1 month to 18 months, 0.6%, so less than 1% for leaveless pacemakers and uh 5% for, uh, traditional trans venous systems. So that was the nano stem data which remember I said got recalled. This is the micro data and I think this is from uh El Chami out of um and John Pacini out of uh Emry and Duke respectively. um, El Chomi's a very big micro guy um and very similar things, right? So you're seeing, uh, at 5 years follow up the micro VR, um, which again is. Kind of one of the earlier gen ones, uh, so the new ones are better 4.5% versus the three year mark for trans venous 9%, so you're expected to be even a bigger delta. The further out you go, what I think is really important in the micro registry, and the same is presumed to be true, there's just not the same type of registry with the current generation of your um device. There were no reported infections at 5 years on the legal system that's gonna have very pertinent, uh, implications clinically as we go on. So I, I said I wanted to make this not just about leadless pacemakers even though leadless systems are primarily in the pacing space, but. Um Our ICDs different, so we have the subcutaneous ICD which I'm not gonna spend a ton of time talking about, but that is a completely extravascular system for uh for defibrillation. This is a praetorian trial that basically compared SICD versus trans venous ICD both in Europe and the US with about 4 years of follow up and again you see a similar picture SICD 5.9% versus 10% trans venous. No infections systemically, OK, you can still get local infections, um, that need removal, but the complication, the consequences of the complication are less lead related complications lower even though there is, there's still a lead, it's just extravascular and need for invasive intervention is much lower, so leads are bad is kind of the story here. So I kind of alluded to this too, so. For patients who are undergoing um lead extraction for lead infection which you saw at at you know 3 years is 5% in the transvenous system um we do this thing where we take them to the hybrid, we extract them, they're dependent, we put a temp wire in, we wait for their cultures to clear for 3 days with a temp wire in place, then we try and find lab space to put advice back in. Then we have to wait a couple days to put the PICC line in all of a sudden you've, you've now taken up a hospital bed that might be an ICU bed depending which hospital you're in for a full week. There's a lot of hospital resources money, um, so the question is, could you just put a leadless pacemaker in right when you extract and the, the answer is unequivocally yes you can, and we've done that several times here, um, including, I think we did a dual chamber ofve like recently with a with a with an extraction. There's like 15 different studies, but this is the biggest one. Uh, that looked at 86 patients undergoing concomitant transvenous lead extraction and needless pacemaker reimplant. Almost 80% of them had active bacteremia. They had not cleared their cultures. They had a 0% infection rate at 6 months, um. Uh, and this is out of, out of, uh, Northwell Health, uh, through Larry Epstein's group. He's one of the big extractors kind of like one of the godfathers of extractions. So I think, I think this is a very, uh, important message both from a, from a clinical perspective and I think from a healthcare utilization perspective. So I did comment a little bit. But yeah, OK, so the complications are lower but. I always talk to patients in the extraction space that it's not really the complications that matter that's the consequences of your complications. So if you have a 10% complication rate but it's like you have a hangnail, right? Like who cares, right? But if you have a, you know, 1% complication rate and that's, you know, death, that that's something you need to talk about so. Unless we kind of paint a rosy picture that leaveless pacemakers have, you know, no significant issues. This is a large, large registry that shows um what happens when you have perforations with the microsystem, which is the um metronic system that's been out for about 10 years, and I think this is a mod database has basically every complication reported so. There have been 600 reported micro perforations of which 500 led to tamponade of which 150 of those led to death, which is a 27% death rate now. If you look at the total denominator, which isn't provided in the study, it's probably quite a lot larger that the perforation rate is, you know, not particularly high, but if you do have a perforation with one of these systems, so I think the same would be true with the veer, you have to be ready to deal with it, um, these are really large. Introducers in the growing 25 to 27 French um and and the system can make a pretty large hole in the myocardium whether it's an atrial implant or a ventricular implant so it's not to say that these devices cannot have short term complications. All right. So one of the big criticisms of um leadless pacemakers historically has been OK, but now we're in the space where we're talking about conduction system pacing and left bundle pacing and we can get the QRS's really narrow um and so these are these are leadless pacemakers I just showed you where the cathode anode is set up and so they don't drive particularly deep in the septum from the purposes of where the actual electrically active part is. So are we doing patients a disservice by giving them leaveless pacemakers so. I can't go through grand rounds on CRM and not talk about Lea's or about pacing induced cardiomyopathy because it's kind of my baby, but, uh, again not trying to name drop too much. This is Bruce Wilcoff who was one of Divs and mine and uh Jeff's mentors. He unfortunately passed away, uh, pancreatic cancer a couple of years ago, but this is the David trial and I'm gonna show you the most trial in a second, but basically this is going almost back 20 years, and, and the question with the David trial was basically. Is you know ventricular backup pacing, so VVI 40 versus um uh AV synchronized pacing at DDD 70, uh, better for patients with uh defibrillators, and we didn't really know the answer to that question, but it turns out that when you do DDD you force ventricular pacing and what you can see it doesn't show up super well but. Ventricular backup pacing was way better than the DDD pacing, showing that right ventricular pacing is bad. Um, there was an absolute 20% increase in death and CHF hospitalizations at 18 months, although it's more driven by heart failure as you can see here versus mortality, uh, in the DDD arm. So this is the most trial trying to kind of quantify the degree to which RV pacing is bad um what you can see here is um. Uh, proportion event fee event free if you pace less than 40% of the time, uh, versus more than 40% of the time they looked at 40 to 70 and 70 to 90, but the cam curves kind of overlapped. What they saw was a significant difference in outcomes here as well. This was in a sinus node, uh. Dysfunction patient population, if you look at these two kind of things, they led to uh algorithms for pacing like MVP and VIP depending which uh rhythmic depending which uh company you look at that basically try to avoid ventricular pacing and sinus node dysfunction. So there has been a lot of debate over the years about, OK, well it's just where you put the lead, you put it in the apex, you put it in the high septum. This is the Protect pace study which randomized 240 patients with high grade AV block that required greater than 90% ventricular pacing with a normal EF to either high high septal or right ventricular apical pacing. At 2 years, the EF basically dropped 2% in both patients. It was non statistically significant. The only difference was that uh there were longer implant times in the high septal region. Furthermore, and I think this is an important thing for Leva spacing too when they had radiology review where it was implanted, a third of the patients that were in the septal region were actually anterior, which is a higher complication rate area. Um And so you know the, the, the idea that people say I'm gonna put it up on the septum because it's gonna be more uh physiological it makes no sense. OK, right, when we do parahi pacing in the EP lab in the ablation space we we drop our output same with conduction system pacing we drop our output basically until we lose his pacing, but we're in the same exact spot. So if it doesn't matter if you're a centimeter from the hiss, you're not capturing the hiss, it's going all the way down to the the apex of the right ventricle back up the right bundle. Um, to get, you know, back to the, to the atrium and to get from the right ventricle to left ventricle, it's gotta go through, uh, uh, gap junction and gap junction, so this makes no. There's there's no surprise really if you think about the physiology with respect to pacing induced cardiomyopathy. Uh, so this is, uh, a paper I wrote again it seems crazy to say it was almost 10 years ago now, um, that, that I think. Probably uh catapulted my career to be, to be perfectly frank and I and I put this up here more because we're starting a fellowship here shortly and I think this is proof that you can you can do a lot as a fellow if you have good mentorship um and so what this study involved is basically a lot of nights and weekends where I went through every single patient who got a pacemaker for. What looked to be AV block at Cleveland Clinic over basically a 10 year period and I created a database and reported on that database and at this time people had talked about pacing induced cardiomyopathy, but there wasn't even a CPT code and now there are sessions on it at HRS every year um so I'm kind of proud that at least in some small way this helped contribute to that. So this is what the study showed, and we are getting back to leave this pacing, but, but I, I think it's important to kind of go through this so. In the study we took patients who had a preserved EF 823 patients. Based on EFs for 58%, OK, and then we looked to see uh how they did in follow up. So, uh, pacing induced cardiomyopathy was greater than a 10% reduction in EF, um, and the reason we picked that is just because Echo has a kind of gray area and so there's no gray area here. The the patients who didn't have pacing induced cardiomyopathy, their EF remained 58%, and that was 88% of the patients, but for the 12% who did their EF dropped to 34%. That's not close, um. The crazy thing is only 30% of the patients got upgraded 70% didn't, and this is a Cleveland Clinic, so you know there's lots of reasons why that might be, but um, the, the, the patients who got upgraded tended to have lower EFs probably because they were getting upgraded to defibrillators, those that had good adequate follow up that we could comment on. Um, the average upgrade went from 30 to 45%, so not quite back to normal, but almost all the way back to normal, uh, 16% non-responder rate, and then 84% were CRT responders with most of them being super responders. The other thing that was interesting from this study is it turned out that the threshold of RV pacing, uh, to induce cardiomyopathy wasn't 40%, it was actually 20%. These curves completely overlap and so the new guidelines, um, that I was fortunate enough to, uh, to sit as part of the guideline committee have updated to say 20%, not 40%. This is also not surprising, you know, if you look at the, the cutoff for PVC cardiomyopathy, it's not 40%, it's it's 20%. So, um, so, so this all kind of um comes back because when we talk about. Pacing, right, so this is standard right ventricular pace. I just Google standard right ventricular pacing and pull an actual EKG from our own patients, but you can appreciate kind of what looks like a left bundle, right, because you're pacing, you're pacing the RV and it's going gap gap junction to gap junction to the other side. These are 2 EKGs within the last 2 weeks of conduction system pacing where you know if you and I cut off like the top where it shows the pacer spikes if you looked at these you'd say oh they have an incomplete right bundle branch block. You wouldn't even think that they were that they were pacing so it's it makes complete sense that these patients wouldn't get pacing induced cardiomyopathy and some of these might. The problem is Lea this pacing is not. Conduction system pacing, so you're gonna get a wider QRS we think um the interesting thing is actually that's not the case so. I'm just gonna kind of more summarize these are kind of hodgepodge of different papers but. This one on the left I actually was one of the reviewers for and I was trying to be super skeptical about it um it's a, it's a paper out of Ohio State and it wasn't, I wasn't being, uh, biased because I'm a Michigan fan but I, I just couldn't really explain why Leless pacing has a lower, um, lower pacing induced cardiomyopathy rate. Uh, but they did a wonderful job with the paper. They use the same, uh, EF drop that we did from 50% prior, and it's 14% in trans venous systems, which is very similar to our 12%, so external validity and only 3% in the, uh, Leless pacing groups. And all the patients in this trial that got CRT just like I showed you in in our paper responded very well so proof that this was true pacing induced cardiomyopathy. Another thing that's been shown over the years is, OK, so how do we identify those 12% or 15% depending which study you look at them and one of the big kind of um categorical cutoffs has been a cure restoration of more than 150 milliseconds. Um, So this is another paper that's uh from Mark Metzl's group. He's one of the, he's actually kind of a thought leader in in Chicago. He works at uh North Shore, which isn't Northwestern or you Chicago kind of proof that you can be a thought leader, not from a huge name institution, but um what he showed in his, in his, uh, cohort was that if you look at that same cutoff of 150 milliseconds in transvenous leads, it's highly predictive of pacing induced cardiomyopathy but not for leadless pacemakers so. Again, I don't have a great explanation as to why this is, but I think we've all kind of recognized this is a trend that we're noting and so perhaps leaveless pacemakers when you're worried about pacing induced cardiomyopathy could be used in a broader population. That all being said, there are limitations to the Gen1 leadless pacemakers. So, uh, the ones I showed you before, the VR Micra and the nano stem which got recalled, they could only RV pace. They had no capacity to synchronize AV, um, and so it was kind of a limited ideal patient population, so permanent atrial fibrillation with a normal EF. High risk of infection that we're like they just cannot get another trans venous system. They end stage renal. They've had multiple episodes of bacteremia. We've extracted them multiple times. The BMI is 16 and if I put a device in it's gonna pop right out of their skin. So those were kind of the ones who are gonna need pacing and then there's this cohort of patients that get just syncope twice per year from true AV block and if they RV pays versus dual chamber pace, it doesn't really matter. They just need to pace through their syncope and so these would be reasonable um options for those patients if insurance would approve it, um, and so. One of the next iterations uh was the AV micro, which is an attempt at and I, and I focus on saying attempt because I don't think it does a wonderful job, um, but an attempt at one device AV synchrony. I'm not gonna go through exquisite detail here because it's, it's kind of hard, but basically the concept is this if you think about the way that uh Sicily and diastole work, right, so. The valves open, uh, mitral and tricuspid. The early atrial filling is all passive, and then there's an atrial kick at the end. So you don't worry about AV synchrony if they're in, in, uh, atrial fibrillation, but if they do have a P wave, you should get some mechanical reverberations, um, and so they, they've basically metronic has A1A2, A3, A4A7, and what they do is they sum these signals for something called the AM or atrial mechanical marker, and when they sense the atrial mechanical marker, they'll try and pace based off that. So, um, and this is there's actually the 2nd generation of this now called the micro AV2, uh, and this is just kind of a schematic that's showing how it goes through this. It's much better. I'm not saying that it's not a. Not a workable system. The problem is that if you look at where these devices are, you know, most implanted, so it's you can't implant them in patients with sinus node dysfunction because it can't atrial pace. It's only gonna time the atrial rate, um, so younger patients, if you're trying, if they have say congenital complete AV block, the algorithms seem to break down as the heart rate goes up, and so you're gonna get a lot of AV synchrony with exercise. Patients don't feel well with that. Another area where I think this is a valuable thing and we'll focus more on is in the tricuspid valve space and so again a lot of the tricuspid valve space patients have severe dilated left left and right atria. They may be in permanent afib and so you might get away just fine with a ventricular device they need an atrial device and you put a trans catheter. Tricuspid valve in or a tri-clip, it tends to affect the um the AM signals and so it doesn't track very well. So I think although this is a better solution, it's not an ideal solution. What's a better solution? dual chamber atrial uh dual chamber leadless spacing so. Again, last name drop, I think so, so this is how you go from reporting on uh uh trans venous complications to being the senior author on a a pivotal New England Journal trial in like 10 years, um. So this was um basically NanoStem 2.0 with two devices um it was presented at HRS in 2023. Um, you can see the devices are slightly different sizes. The atrial device is smaller than the ventricular device, but very similar to the original nano stem set up. So basically what this trial showed and we're gonna go through the technology in in a second was that you could get very good communication and lots of different um uh clinical scenarios of sitting, laying laying on your left side, right side, standing, walking fast walking, the synchrony was very good, 96% to 98% um with this system. So how does this system work? It's this thing called eye to eye communication or implant to implant communication and so the devices are looking at each other basically top to bottom and bottom to top, um, every cycle and so the tracking can go up to 180 beats per minute that kind of fixes that issue I was talking about with younger patients, um. And the next couple of slides just because I think they do a better job of it than if I tried to do my own are just for full disclosure from Abbott and this slides I showed you before on Micra were directly from Medtronic um so. Basically what it's gonna do is it's gonna look. Um, before and after and then after and before, uh, and so, uh, so for I'm just gonna basically kind of read this off, so for a pace beat communication is sent immediately before the pace beat occurs to to notify the other implant or the other device that you're gonna get um a pacing spike into the look so to look for that. So, um, for sense beats it's after the sensing is is detected that makes sense right because you know when you're gonna pace. You have to see something sensed, uh, but within 5 milliseconds, so this is 4 milliseconds ahead this is 5 milliseconds after, um, and again the communication occurs both ways. So the A communicates to the V if it's paste, hey I paste or I sensed look for it. The V will say I paste or I sensed. So there are all these markers on the channel, so, um, this little O on the interrogator um will show uh interruptions in the communication. So, um, if you see this, it's the VA, um, communication if you see it in between, it's an A to V uh communication, um, issue. So these are just kind of some examples of where the breakdown would would make an issue. So this is the atrial to the ventricular unit is being lost and so you're seeing this little circle right in front of the V pace and so you're losing AV synchrony in this patient population, um, on this one you're seeing, uh, VA communication loss so it's marking before the atrial channel up here. So on the interrogator there are a lot of different ways you can try and help fix this and obviously the trade off is always battery life but um this will tell you the strength of the communication back to forth. This is a setting level that goes 1 to 7. Higher you set the, the, the setting, the more it tries to look, the more it drains the battery, but it'll tell you the eye to eye communication and follow up when you interrogate the device, um, VA, A toV, um, and so you can get all the diagnostic information. I, I was trying to do my very best in this talk to not do a lot of uh text just because I think it would be really really boring and so the remainder of the talk is gonna be pretty much videos. Um, I also have audio on the videos. um, I, I think I edited out anything that would be bad, um, for those who are online, I had to kind of put this talk together a little faster than I normally would want to, so this is an actual patient case from a couple of weeks ago. It's not probably the best case, it wouldn't be the one I would have picked. You don't get to choose the case you decide to record, so thank, uh, Ricky and and Bruce from Abbott who helped record this, um, and I thank Heather Robinson, or not Heather Robinson, Heather Martinez, who's, uh, scrubbed during the case, and Frankie who had to sit there and not, not, uh, suture for a really long period of time, um, and so they're gonna be the stars of this show. All right. So The first thing you're supposed to do is you're supposed to mark out the right atrial. So this is a dual chamber implants on a patient actually who we took out the tricuspid leads because it was implanted, uh, not the transvenous leads it was implanted 11 months ago, the severe TR and we pulled the leads out and actually the TR got much better, um, and so the hope is that they won't need any tricuspid valve intervention but they did need dual chamber, uh, pacing but were in a fib at the time of the study. So what you wanna do because you wanna have. The implants about two device lengths apart as you want to mark out the right atrial appendage and of course in this case uh we didn't have the right pigtail so all the contrast was coming out like the back end of the pigtail you couldn't see anything so um I'm sitting there singing where is the right atrial appendage in this video um but basically you start by putting the patient to sleep with uh anesthesia you get a uh ultrasound guided. Uh, large bore access, it's uh 25 outer uh for the Avir I think it's 27 or something like that or similar for the for the micra, uh, and then you basically put a pigtail up and you get REO and LAO shots. So this is not that patient because I could never find the appendage, uh, with contrast, but this is just an REO, uh, REO 30 LAO 30 shot of what the appendage, uh, looks like in a different patient we did, um, and what you're essentially doing is marking out a reference that once you put your ventricular device in place, you know how far away you are. So for the atrial unit, the LAO tends to be your working view for the um ventricular um device. REO tends to be your working view and you're checking the other one just for positioning. So, um, so we've gotten our IV access. And we're putting in this large sheath and you can kind of see how large this is. It's actually a very lubrious uh sheath so like if you just try and grab it with your hand, it'll slip right over the sheath. So I, I find it's really helpful to to grab a gauze and uh and and help, uh, push it in there. You wanna have a stiff wire, so this is we use like an extra stiff and plats throw it up to the SVC and then insert the device uh over it. So you can see how big this device is here um. We usually just get like uh 8 French access for the um or 9 French access for the pigtail shot and then we have like a a a graduated um tapered dilator that we use to to kind of get from right from 8 to 20 and that's what the sheath looks like on floral. At the end we close this with a figure of 8, but um you could you could dual per close if you wanted to too and I've done that before. Um, so I hear the laughing, yeah, so normally you wanna have a big long table and we didn't do that in this case, so it's made it way difficult, but this is actually the delivery sheath and uh. So what you can see in here is we're clicking in the leadless unit to these little two tethers, um, and I'm gonna uh I'm gonna basically realign the tethers and then we're gonna actually remove the device and make sure it's still tethered. I think what I'm saying in this video is don't drop it, it's expensive. Um, but Heather's gonna hold it there and then, uh. I'm gonna click it back and it'll attach back right there and then there's this uh plastic kind of thing you can see that's attached to the blue that's a protective sleeve talk about the risk of perforation the consequences of perforation so it's actually quite a soft um uh soft thing that you advance in in front of the device so it doesn't get caught on anything and you can advance it, uh, nice and easily over the uh over the device and then into the septum. And you can see that the torque ability of the sheath, uh, you can really almost take this a full 180. So there's a lot of flush lines for the Avir. I don't know if there's an engineering flaw, but look at the syringe as we insert the device, how much, uh, uh, how much saline is being pulled in. So if you don't have a flush line hooked up or a syringe hooked up, you could, you could suck in about I think it's about 30 ccs of air. So this is something you just need to be aware of. So here we're crossing the tricuspid valve with the the device and if you see over on the right part of the screen there's um a little bit of ectopy as we cross right there. So that's how I know I'm I mean other than just flora I'm in the ventricle and I'm touching something, but that's not good enough. Um, this is one of the big, big advantages we'll get to in a second of the ave over the microsystem, but. One of the things we do with both systems is to do contrast shots. So again this is the view I'm gonna deploy in the RAO view, but this is an LAO view showing basically we're pretty well opposed to the septum could could be a little bit better, but in this case reasonable. So you can actually test the device and look at the injury beforehand. So for for those who are not EPs, injury basically should look like a stemmy. It shows you have tissue contact. So this is the sensing, so good sensing of where I'm gonna be, you know, pacing and sensing from, and then this long, uh, injury of the device showing good contact. But you can also pace beforehand and see how good are my capture uh thresholds. He's 2 1/2. So here's Bruce. 121 bolt. You see we lost there. So I mean, is there a number we look for? Not necessarily, but we wanna see, uh, that we can capture that we've got good sensing and that we have good injuries, then we're ready to deploy. So what you can see on here is this little V or Chevron. What we're gonna do is we're gonna rotate it 1.5 turns in total. I don't think I show the whole thing here just for for the sake of time, but we're gonna rotate it 1 and, you know, 3/4 to 1.5 turns, uh, from a reference that we've put up here already. And that's uh that's how you know it's deployed. The same thing is true uh in the atrium as well which uh we'll show in a little bit more detail. You don't want to overturn it. You don't wanna underturn it, um, so 1.5 is kind of the sweet spot. So this is a deflection test you basically are gonna untether it the ventricular and the atrial are different and you're basically gonna take the deflection knob and you go up and down and make sure that the chevron does not move so we're doing that right now. And then you wanna kind of realign it for all your testing thereafter. So after we've redone all that testing we're gonna release the device and there's these two little metal pins on the back end and you'll see it, uh, misalign here in a second, so bang we're out. And so we can remove the device and now we're on to the atrial unit. I'm not gonna show you all the prep again it's the exact same, but this is uh this is in the LAOU positioning the atrial uh unit. This case was extremely difficult, so, uh, uh. I don't have great contrast stuff for you in a variety of things. I think this is like our 7th deployment attempt, but um this is our successful one. So we're gonna inject through the uh through the delivery sheet. You can see that we're we're well opposed to what appears to be the left atrial appendage in this patient and then in REO you can see the REO shot over on the right side of the screen over here. And we're just confirming. That we're still in that same position because we've repositioned about 7 times so so when you're ready to deploy, I didn't show you this as much on the ventricular unit you're gonna take the protective sleeve back so that the actual times are touching the tissue. So sometimes the device will go up or down in this case it it tends to drop a little bit which is OK, so it's a little bit lower than I would normally like but this is the only place we could get any contact. And then again we turn it in the same way tension tests on the AR unit is very different, OK, so, um. I've now deployed this one. It's always a little unnerving when you do this, but you pull it out and you're like, uh oh, it looks like it dislodged. It didn't. It's just the atrium and the right atrial appendage is, is kind of a weird shape, so you kind of pull down to get it in this position and then what you're gonna do is basically just pull tension on it multiple times and it is 2 or 3 times in this, uh, in this particular case just because it was difficult. So now they're both released. You'll see Frankie stick her head out saying oh my God, I can see her now. uh, so, um, so that's that's kind of a pro probably not the best example but the one I had to to show you of a dual chamber of ear implant. So we talked a little bit earlier about device retrievability, um, so the dual chamber of ear system came with a snare. That's a difference, uh, compared to the microsystem. One of the benefits of the recall was they were forced to extract a lot of these and so this is a paper by again Reddy and Cantalon same same folks again and again and again stratified by years, so 0 to 1 year, 1 to 22 to 33 to 4, and greater than 4, and I think the furthest one out in this study was 7 years, but pretty good, uh, retrievability overall 88%, uh, uh, complete, uh, retrievability of the nano stem. Um, and there was about 200 patients, uh, the low complication rates less than a couple. There was some tricuspid valve injury in a couple of these, uh, but no deaths, um. This video over on the right um is a video of us it's not a great video but actually this snare can be used to extract micros since there's an actual micro that I extracted um I haven't had to extract any of the avis clinically yet which is nice, but this snare actually has, it's a wonderful snare and the first time I think all of us got trained on it we were like, well this is a great thing for for fragments up in the hybrid on trans venous leads, um, because it's a big enough sheath you can actually grab the leads and pull them back in. So you know who's a good patient for a VR in my opinion, whether it be an atrial unit only because I showed you a dual chamber, but you can just do atrial unit only or a DR so I think isolated sinus node dysfunction, this is a pretty good device if you need only atrial pacing, you can not have a lead in the complications related to that, um. You don't have a battery, you know, you don't have an incision. I think that's a good patient. Post extraction, you know, even with active bacteremia, depending what their long term situation is, if you could use this as not just a bridging device but their long term device, there's huge financial implications and length of stay, you know, bed capacity implications of this device, um, and then as I discussed trans catheter tricuspid valve interventions to avoid jailing leads, particularly if you're having to extract and when AV synchrony is needed. There are some limitations though of the years so. Uh, limited storage for electrograms presently that's mostly to, uh, prolong battery life. Um, as of right now there's no remote monitoring for the device, although that's expected to change I think in Q3 of this year. Um, the, the units themselves, so like the atrial unit, uh, Abbott may correct me when I say this, but I think in the real world you could get 10 years out of an atrial unit and 20 to 25 years out of the ventricular if they're doing their own thing, but you put them together, the atrial can only last 3 to 5 years and the ventricular 10 years and so then. Not only are you having to extract devices, but you're having to kind of do them at different intervals you might be doing procedures a lot of the time. I, I expect with current generation involvement that this will change over time, um, but these are some issues that we have to think about so there's actually some places around the US that are implanting. An AV micra and an atriallavier because you can get pretty similar battery and longer battery lives out of both of them you're gonna lose a lot of capacity with that but that's but that is another alternative approach and then the, the big red flag here is right, even though I showed you there's less um pacing induced cardiomyopathy with leadless systems, there's currently no leadless conduction system pacing option uh nor uh any uh ability to upgrade without having to extract uh to traditional CRT. So if you're wondering who of us does this, um, again this isn't really this is a um CME talk, not an industry sponsored or bashing talk, but Abbott's done a pretty poor job of rolling out this device. It's been out now for almost 2 years, um, and all of us would like to be trained, um, currently myself, Doctor Patel, Doctor Woollett are fully trained, uh, Doctor Ayer and Doctor Ola Cesi are VR trained. And we're hoping to get all 9 of us trained here shortly from a micro perspective I'm pretty sure all 9 of us um are trained, uh, plus Doctor Chuo um. And so, uh, that's where we are from a lead this perspective, um, in terms of where we implant them, um, I can't speak to Virginia Beach, um, I do implant, uh, uh, and I know we have implanted lead lists over at Careplex and we certainly do them over here as well. Alright, in the last couple of minutes and then I'm gonna leave like 5 to 10 minutes for questions. I just wanted to to comment that you know this is a talk mostly on pacing, but the defibrillator space is important too. So, so Boston Scientific has a uh has a has a system where you can implant a leadless pacemaker and communicate with the subcutaneous device called the modular ATP. Um, we were part of that trial. Uh, John was the site operator here and so I joked with him that he, he got into New England Journal before I did, uh, and, uh, and, uh, I think Alan and I were the sub investigators in that one, This is a cool video. I videotaped this with my iPhone, so I apologize for kind of like the unsteady hand, but this is the way the device works. So you have a leadless pacemaker in and a subcutaneous ICD you see the patient go into VT. The subcutaneous ICD notices the arrhythmia. It says, OK, this is VT. It then communicates to the leadless pacemaker and tells it to ATP or anti tachycardia pace. It paces at a rate faster than the BT and restores sinus rhythm. If it fails, the defibrillator shocks. This is a way to do defibrillation and ATP without any leads. So I commented earlier the tricuspid valve space matters and we had a talk, uh, I think 3 weeks ago where both myself, um, Doctor Yea and, um, Doctor Summers talked about a case where we did extraction and tricuspid intervention that needed a um tricuspid clip. We've done about 4 or 5 planned cases where we've said, OK, you know, a patient has severe TR whether it's lead associated or not, um, it would be best for the tricuspid valve if we could take the, um. Take the leads out of the equation. They were good lead list candidates. This is an an older gentleman who this is his X-ray doesn't show up real well before, but you can see his, um, pacemaker in here and then afterwards I almost had to show you where his leadless pacemaker is, which is a ventricular only unit. But you can see the torrential uh 5 + TR before and after the tri clip which you can see really well here and they'll leave this in place we've reduced it to 1 to 2 + um so I think to my knowledge I think we're the only ones in the US that are doing these con concomitant procedures, but I think you're gonna see a lot of it, uh, in the near future. So future directions, then I'll stop here. So, um, Abbott just recently announced the release of the first enrolled Leless pacing, uh, device. I'm doing everything possible to make sure that we'll be a site for the study whenever it comes, um, in the picture that's Vivek Reddy, whose name I mentioned a lot in the in the talk on the right. And then uh Peter Neuel uh from the Czech Republic on the left, it seems that all first in man things happen with Peter Neuel and the Czech Republic there must be not really a lot in the way of restrictions there in terms of uh. HPI and and kind of uh novel technology uh compared to the US um but that's how we get things started. uh, this was done on December 17, 2024. It's probably a couple of years out uh in the US, but, but we'll be exciting to see and Abbott's not the only one designing this. Medtronic's got something. Bronic has something. I'm I'm sure Boston has something as well. Alright, with that I'll end um this is just a. So I take a golf trip as most people know with all of our, uh, with a bunch of our colleagues once a year, and we've been trying to go to Bandon Dunes in Oregon where we went like 4 or 5 years ago and they have this lottery. It's like trying to get Taylor Swift tickets, to be perfectly honest, and uh, and we were, we're lucky enough to get it so this is for Justin Heiser and Jeff Headley and Paul Levine if they're watching this is where we'll be going in a couple of years we just found out last week so I'm, I'm pretty excited about it. Published April 4, 2025 Created by Related Presenters Erich Kiehl, M.D. Sentara Cardiology Specialists View Full Profile
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