Chapters Transcript Video Advances in Leadless Pacing Technology friend. And so it really is an honor and a privilege to be here. I mean this is a really beautiful setup and I'm so thrilled to see so many of you come and hang out with the cool kids here in Ep you know, so thanks for doing that. But in all seriousness, listening to Dr O'neill talk because we're gonna be talking about advances in leaderless pacing and defibrillation and that whole sort of first in mankind stuff. And listening to him speak about his first patients and the altruism that they expressed led me to remember back to my first patient with lead less pacemaker, A woman who went on to want to share her story publicly. She was interviewed by media and whatnot. Her name was Marlene, she's now past but from other reasons and she had just crashed her car into a telephone pole, had passed out and I was talking to her about a leaderless cardiac pacemaker and she said dr Kandel and how many of these have you done? And I said in people or in sheep and she laughed and I said you know none in people, but you know all the sheep have done great. And she got a little twinkle in her eye and she said dr Kendall and I want to do it, I wanna be the first. And I said okay, Marlene tell me why is it that you want to be the first and I'll never forget this answer because it was the same thing that dr O'neill's patient, I said to him, she said I know that if if this isn't going to help me I know it's going to help other people. And when that type of altruism comes from a patient in the exam room, it just absolutely barrels you over because when somebody is sick and they've passed out and they've crashed their car into a telephone pole and they can think about others. It really is a tremendously humbling experience. And so, you know, this is why are we on this journey of leaderless cardiac pacing? Is this just all about gadgetry and technology? And no, the answer is basically on this slide. It's because, you know, in the United States, unfortunately, we don't always publicly report our complications, but we never failed to build for them. And so we did this analysis of the claims registry for complications from trans venous systems. And when you look at the data, one in six patients by three years is going to have a serious complications. So what does that look like? You guys know with Dr kiel and DR Patel here being a big referral center for extraction. You've got people coming all over the mid atlantic with pockets that are infected with leads that are fractured with vina Kaveh that are included with venus inclusive disease. And not to mention the stuff that paul was mentioning in the previous session about the trick a spit valve and the leads going across the spit valve and all the mischief that that can cause in terms of Tr and right sided heart failure. So all of these reasons are the reasons that we got into leaderless pacing in the first place. And so these are the two we're going to start with what's FDA approved and then we'll move on to the investigational stuff. So these are the currently two FDA approved devices, the vera system which has a helix sort of a longer tubular device, kind of more analogous to a triple A. Battery and then the micro which has those times which really have to punch into the tissue and grapple the tissue sort of a shorter stockier device. And so this is the two FDA approved devices that are on the market for single chamber of ventricular pacing. And so the first question is, okay, so does it do what it's supposed to do? And we don't yet have a randomized clinical trial to go trans venus versus lead list to prove this. So we do the next best thing which is propensity matched studies where we take, you know, cohort of trans venous patients and we match them. So they're same in all respects except those that get the lead this device. And we compare them sort of simulating a randomized clinical trial. And what it shows is that when you take away the surgical pa pocket and you take away the trans venus leads, you lose those mid and long term complications that really affect our patients that have those implanted trans venous system. So that's really the hope is that if you can go lead list, you can get rid of the pocket infections, the fractures, the venus inclusive disease. The disease associated with putting trans venous leads across the track, a spit valve. And so you know, there's a lot of fuss about, Okay, so what's this big deal about the helix versus the teams? Um So I want to show the data from our new England Journal paper. You know, the phase one was the first initial study that we did. That was published back in the new England Journal Medicine versus the phase two when we had refined the system and made it a little bit better. And what we had, what we had changed between, you know, sort of version one, which was the nano system to version two, which was the affair is we allowed ourselves to do contact mapping. So when you deliver the catheter up into the heart, you can actually just touch it into the tissue and you can sense you can pace from that occasion. Okay, this looks like a good spot. I'm gonna go ahead and I'm going to fix the helix here as opposed to moving it to another location where we have better thresholds. And when you look at the data, just call your attention to where I bolted it on this table. You know, the number of times we were able to implant the device without having to reposition it. Um, you know, less than 70% in the initial phase one cohort, which was the nanny system device. And then for the phase two, you know, over 80% of the time we were able to put the device in and and and not have to reposition it. And that's a big deal because the risk from leaderless pacing comes from a lot of the trauma to the tissue and risk of perforation or tear. And so to be able to go in and pace map and find a candidate location before you commit yourself is really important. Whereas with the Micra you have to just basically, you know, punch the times in and and hold on to it and just expect that, you know, the electricals are going to be good, like a leap of faith and if it isn't then you have to go back and you have to recapture it and you have to reposition it. So that's the big deal about it, Felix. The other big deal about the helix is, you know, they were talking the previous sessions about, you know, the long term strategies of patients with valvular heart disease and you know, how many valves and you know, what are you gonna do when the valve starts to fail? We have the same problem in electrophysiology, we have to think about, okay, if this is a young individual and that battery is gonna give us 7 to 10 years, What are we going to do in 7 to 2, 10 years. And the nice part about the helix is that we're learning that we can retrieve these devices per cutaneous lee. And if you look at the data that we've published, you know, looking at acute and chronic retrievals with gen one technology, uh you know, we're seeing 94% success on the acute and 91% on the chronic switch have been implanted for more than three years. And so, you know, we've written a lot about this and this is just a movie where we've snared a device and then putting the sleeve over it and we actually can unscrew it and remove it from the heart. And I've been using a lot of inter cardiac echo and I can't overstate or overemphasize the importance of imaging because it's all about getting that docking button. And so you can use the inter cardiac echo in real time to snare the end of that docking button. Because in the situations where you snare the docking button, it's actually very, very easy to get these devices out. The failures that we do see is when that docking button is sort of scalloped underneath the septal leaflet of the valve are trapped under a moderator band. And so that's when we have to get creative and we have to put ablation catheters and try to move the device back end out, you know, so that we can snare it on the front end. So there's a lot of sort of ad hoc macgyver ring if you will to try to get these devices out. But you know being extractors makes us better in planters. And so we've learned from our extraction experience to leave that docking button square in the mid cava terry part of the right ventricle. So it's easy access For us to go in and get it out. And so we've even had you know from our very first implants that lead list devices in 2014 we've had seven and now eight-year chronically implanted devices like in this elderly patient where we've been able to retrieve the depleted battery, replace it with a new device per cutaneous Lee in the same procedure which is really really pretty cool when you stop and think about it. So now this gets us into the leading edge the cutting edge the non FDA approved stuff. And so this is the dual chamber lead list stuff. And what we've done, we've modified the design of the atrial device to accommodate the fact that that atrial tissue is thinner and you need your fixation to be a little bit different. You need the device to be shorter because you don't want the back end to swing into the valve and to interfere with valvular function. And what you of course have to have is you have to have this eye to eye communication devices have to talk to each other to truly function as a dual chamber leaderless pacing system. And so it does that by delivering pulsations that just read like any other E. K. G. During the refractory period there is a signal that's transmitted that wakes up the other device. And just a series of one zero's a coded message just like any of our computer systems work with. And that tells the device what it's seeing, it tells the other device what to expect. And so we have both A to V. And V. To a communication and it's continuous. It's on a beat to beat type of basis. And so does that work? Well this is published data that comes from the animal model. And I want to emphasize that when we talk about this eye to eye success rate or eye to eye throughput, it's not the same thing as a v synchrony because even if you lose eye to eye throughput for a beat or two the device or the system, the patient can still have a V synchrony. And so in general a v synchrony is greater than I By throughput. But in the animal model with the 1st 10 animals that we did that were followed up for 13 weeks and we literally have guys out in California that are chasing around the sheep to see how these pacemakers are performing. We saw that there was an extraordinarily high percentage of fidelity with eye to eye throughput of 99%. And what about postural changes? Well it's a little tough you know with animals that walk on four as opposed to us humans that walk on two. But again you know crazy stuff that you do in the name of science. You know you know flipping these animals over on their sides, Postural changes. Left lateral, right lateral supine standing. We saw that there was robust ideye communication because again it's not using Bluetooth, it's not using wifi, it's transmitting a coded E. C. G. Signal that's going through the body and it's being received by the other device during the refractory period of the device. And so these are teasers. Okay so we have the their D. I. Clinical trial D our clinical trial, it has closed enrollment, both the United States and europe. And so you know we're having our patients and follow up now. So I'm presenting these just as teasers. But this was our first patient uh in the United States. The 60 is is doing great 68 year old male who had really had a bad go of it with spc syndrome. He had had syncope P. A system. He had an underlying left bundle branch block had a trans venous system implanted in 2016 complete venous occlusion. Had undergone vino. Plasticky had recurrence, couldn't even bend over to tie his shoes without getting lightheaded, dizzy passing out very severely distended chest veins? Severe headaches. The worst kind of spc types of symptoms. So what we did is we extracted the trans venous system and he is our first patient in the United States for the dual chamber uh lead this pace. And what I'm showing you here is going up with the catheter, delivering a contrast injection into the right atrial appendage, which just like the left atrial appendage has got a lot of nuance, a lot of different, interesting things that you see with the anatomy and the variation. And we've learned a lot about that as a result of this trial and the importance of using ice imaging to be able to appreciate that. And you can see um the little kind of wing on the, on the right panel with the ice image of this device being tucked away at the base of the right atrial appendage. And this is a little again teaser of when the first uh atrial device was released, you know, kind of a tense moment. You can see that I'm sort of just, you know, tugged it a little bit there, make sure it was stable and then ultimately let it go. And then a little cena Flora Skopje. And you can see the way that that, that atrial device moves because the right atrial appendage is a very violent structure. It doesn't beat just in two dimensions. It twists and so you see is with the ventricular device, there's a very predictable bobbing type of motion. But with that right atrial device, you can see that it's swaying to reflect the motion of the right atrial appendage. So this was it. This was the first case and these are just again some teasers to show that it can do what it's supposed to do. Which is the dual chamber pacing. These are actual you know chest x rays. We can see you know something we're gonna be seeing more of is these little devices in the heart. And it's always fun for me to kind of try to fool the radiologist. The radiologist thought that was a loop recorder and like nobody that's inside the right atrium and uh you know so really paced ventricular sensed a really sensed ventricular pace. So true dual chamber pacing. So I'm gonna pivot a little bit and talk about subcutaneous defibrillation. And you may say well why subcutaneous defibrillation? It's the same reason for for lead lead spacing is we want to get out of the vascular space. We want to avoid those lead related complications. So the traditional limitations of S. I. C. D. S is you you you don't have a T. P. You don't have bradycardia backup support but of course you get rid of the leads. So who needs bradycardia backup pacing with an S. I. C. D. Well we don't know but these are some of the patients we think about patients who have had VF that needs some post shock pacing which the S. I. C. D. Can do. But anybody that's ever seen trance cutaneous pacing, you know there's a special place in hell for for those of us that have done that you know because it really is cruel to the patient to get that type of stimulation. Um And then infrequent a V. Block and pauses. A fib was slowly conducted ventricular response is basically those patients that don't need a lot of pacing but when they need it they really you know need it and you just need to fill in the gaps by delivering some some beats there and then on the 80 P. Side. You know again who needs a T. P. The answer is a little bit unclear. But these are some of the patients that we think about obviously those patients that I've had a history of rapid sustained monomer for VT secondary prevention I cd patients where again you can pay terminate that VT. You don't have to shock them. It's not like VF. Where you know it's always a shock a ble rhythm patients that are post VT ablation because of the high recurrence rates, patients with big scars like the big inferior wall that I'm showing you here on our ep map. This is a patient that had an R. C. A. Infarct with scar. And we took for a VT ablation. And for those of you that aren't familiar red is dead. And so they that's the kind of lifting up the heart showing of the inferior wall and that huge scar. And also those patients with frequent non sustained V. T. I won't go into the mechanisms of a teepee. But basically you pace into the circuit, you render the tissue refractory. So either you block anti drama core orthodontic you allow it so that the head can catch the tail and it abolishes the rhythm. And we believe that advice about 75% of cases you can painlessly terminate VT. So this was the first uh leaderless S. I. C. D. In the world uh that we again we had the privilege of doing uh in december of last year where the S. I. C. D. Was implanted. The lead list was implanted. And what you're looking at on the slide here is a little piece of of crm history because this was our patient who went on to actually have V. T. And you can see um you know if you're looking at that bottom left um patient starts and scientist goes into a monomer VT. And where I put those red arrows is where the A. T. P. Comes in and fuses and ultimately terminates the VT. And if you look very carefully right at the bottom right the patient goes back into VT patient actually came in and storm and we had a bladed and she's done well. But but basically this system allowed uh you know her to have painless termination. VT and saved her some shocks which was a win for her and for for science really because this is basically the first time that A. T. P. Has been delivered through a leaderless pacemaker device. And Dr Patel you know has been involved in a lot of that because Dave and I were working very closely together at the time of those first few patients in the ma trial. So it's really exciting to me to get the modular trial going here at Sentara with with our with our former fellows. And so I'll end on this slide. You know what's the future? It's in this truly modular cardiac rhythm management. So you only give the patient what they need. Some patients with pure sinus node dysfunction. They just need that h relentless that's it. If they need a dual chamber device atrial plus ventricular pacing. If they need the I. C. D. The S. I. C. D. Can be added in. So for some patients you know those with um long Q. T. Syndrome maybe it's just gonna be the S. I. C. D. No pacing support for some patients with sinus node dysfunction. Just the atrial device and everything in between. So you can add or subtract issue. Need you've got a system where you can retrieve the devices you can re implant per catania slee and and of course the holy grail now is conduction system. Leaderless pacing going in and transept only capturing that left bundle. Um It's gonna happen. Okay I'm telling you it is going to happen. It's just a question of time before we have that type of capability and then some really cool concepts. You know this idea these tavern patients, these severe patients, new left bundles. We were talking in the break in the previous session about patients that have recovery from complete heart block. What what if we just put in leaderless pacemakers that could serve as a as a as a long term short term pacing solution to pace them until they recover and if they recover, go in per catania and take the pacemakers out if they don't leave them in, you've got a long term pacing solution. So I think there's a lot of opportunities in the future for research and to really sort of build out the use cases for these entirely leaderless systems. So I'll conclude my comments there and thank you all for your attention. Published Created by Related Presenters Dan Cantillon, M.D. Cleveland Clinic
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