I think we'll get going because your time is valuable, not that ours isn't either. This talk is on, to be or not to be, transvenous defibrillators versus extravascular implantable cardioverter defibrillators. I'm Mark Schoenfeld, past president of Heart Rhythm Society and professor at Yale. My honorable co-chair is Reino Knops from the University Medical Center at Amsterdam. The structure of this debate is that we will have Dr. Mason speak first, followed by her worthy opponent, who we'll introduce next. Each is allotted 15 minutes, then five minutes of rebuttal, and we anticipate that their discussion will be so thorough that there will be no need for follow-up questions, but if you do, there will be 20 minutes. I do want to just, in passing, say that there's been a long history of, or a long tradition, I should say, of debate within NASP and Heart Rhythm Society, going back to the founding fathers, Warren Horthorn, the first president of NASP, and Cy Furman, one of the earlier presidents as well, would delight in debating each other all the time. This debate was always very, very informative, ever so slightly humorous, actually it was invariably humorous, and it gave people a chance to take sides that they either believed in or didn't believe in, but ultimately everybody emerged friendly. But the two of them in particular, I should say, were so engrossed in the concept of debate, and having been in debates myself, I can remember once being involved in the facilities between two talks, and being rapidly approached by Cy Furman, I was indisposed, but he used the opportunity to say, I must debate Warren again, please set it up as soon as possible. So, long history of debate, let's get on to the first topic. We have some household messages that we need to get through, sorry, I'll take care of that, so welcome everyone to San Diego, I'm also really glad that we have this session, because I was involved with a lot of debates between the transvenous ICD and the subcutaneous ICD, and to my knowledge, this is the first debate between the transvenous ICD and the EVICD, so this will be very interesting. If you're not already done so, you should download the HRS mobile app, so that you can ask questions through the Q&A session by scanning the QR code, and HRS is kindly asking you not to take any pictures, not of me, not of Lucas, because it's strictly prohibited, so those were the household messages, and let's get on to it. So our first speaker is Dr. Mason, who's from the University of Virginia, and her talk is that extravascular ICDs are the present and future, and transvenous ICDs are dinosaurs of the past. All right, well, thank you very much, and I appreciate all of you being here on a Saturday morning, so I am indeed going to convince you all that extravascular ICDs are absolutely the way of the future. So I'm going to frame this around a case. This is a patient who was referred to me, 51-year-old woman. She has a history of postpartum cardiomyopathy, and she was referred to me because she had a lead fracture, and I do lead extractions, and so her story was that she had peripartum cardiomyopathy, and in 2007, she received a transvenous single-lead ICD, and this device was, I said Abbott here, but I guess technically back then, it was St. Jude, and she had a Dorado lead, and she has received appropriate therapies. When she originally got the device, it was for primary prevention, but since then, she has had five previous episodes of VT successfully treated with anti-tachycardia pacing. The last of these was three years previously, and one prior episode of VT that failed ATP and went to shock, so she's now secondary prevention, and she has a fractured lead. So when I saw her, this is her ECG, and I think we'd all agree that shows sinus rhythm, maybe a bit of a first-degree AV block, but certainly her QRS is narrow, so no evidence that she has any pacing needs. And this is her ECG, or I'm sorry, this is her chest X-ray, and that shows that she has, again, a single-lead transvenous system, and anybody who does lead extraction never loves to see that SVC coil, but that's what she has. So there's further testing done. She has a venogram that shows she has severe focal stenosis of the left subclavian vein at the access site with heavy collateralization. A CT scan is performed, which shows that she still has severe reduction in her EF, and she also has severe tricuspid regurgitation, likely related to leaflet tethering by the ICD lead. And then she has a CT scan, which we'll often do in preparation for extractions, which shows that the lead is in the apex of the heart. So when we talk about all of the problems with transvenous systems, you know, she kind of has a lot of them, right? So she's got a lead failure, so transvenous leads are hollow, right, because they're stylet-driven, and so they're prone to fracture. She has vascular occlusion. Fortunately, she doesn't have any symptoms from it as of yet, but it's certainly she could in the future. She has severe tricuspid regurgitation, right? This woman's 51 years old, and now that's something she's going to potentially be dealing with for the rest of her life. If we do extract something, it's going to be a high-risk extraction, right? She's got a dual-coil lead. The tip is in the apex, and this lead is over 15 years old. Now, she doesn't have any infection-related issues right now, but every time we enter a device pocket, there's increased risk of infection. And we do know if we abandon this lead, if we, you know, do a venoplasty or something like that and just add another lead, her risk of having infection in the future is greater. So while she's benefited a great deal from this transvenous device as far as being secondary prevention, she certainly is having a lot of the issues we know are associated with these leads. So when this patient presented, one of my new EP fellows said to me, why on earth did anybody put a transvenous device in this patient? Why didn't she just get a subcutaneous device, which made me feel very old because, of course, the answer is in 2007, we didn't have any other options, which is why she got that. So subcutaneous devices, we're all familiar with these, and this is obviously a picture. This is a Boston Scientific product. The generator sits in the axillary area, and the lead is entirely subcutaneous. So it tunnels from the pocket to the bottom of the sternum, anchored there, and then tunneled on top of the sternum towards the sternal notch. So we've had these commercially available for over 10 years. The defibrillation efficacy is excellent. Atrial arrhythmia discrimination may even be superior to some of the transvenous devices. Less likely to get infected, and certainly less likely to cause bad infections like endocarditis. Lead failure is less likely, because this is a solid lead. Better cosmetics, potentially. Many female patients prefer to have the generator in the axillary area rather than up in the shoulder. As far as concerns, we do screen these patients in advance for T-wave oversensing, and it's not a huge amount of patients, but there's a small number of screening failures. This device cannot do, in addition to any basic pacing, cannot do anti-tachycardia pacing. So if you need any therapy, it's gonna go straight to a shock. And then there's still, even with screening, some risk of T-wave oversensing. Then more recently, we have the extravascular ICD. In the United States, this has been the market for over a year. The generator sits in roughly the same spot as a subcutaneous device, so in the axillary area. The lead tunnels to the bottom of the sternum, and then rather than being on top of the sternum subcutaneously, the lead is actually retrosternal. And these are figures from the New England Journal paper. And this device has very good success. So the first panel is showing defibrillation efficacy, which again is really quite good. And if you look in panel B, that's freedom from major system or procedure-related complications. And again, very good. And I'll also point out that what complications there were, weren't things that we all worried about with this device, with the lead being put in the retrosternal space. They weren't things like perforating the pericardium or the heart. A lot of these were things like lead dislodgements, which are things that we will also see with transvenous systems. So the extravascular ICD does not require any pre-procedural screening. It does do anti-tachycardia pacing. It doesn't do basic pacing, but it can provide anti-tachycardia pacing. The generator is a bit smaller. So concerns that have come up with this device is, the biggest thing is you cannot use this device in patients who've had a prior sternotomy or a significant sternal anomaly. Again we're tunneling this lead in the retrosternal space, and so those things can cause a lot of scar tissue. And then we're following issues, obviously we're near the atrium, so issues of potential P-wave over-sensing, or myopotential over-sensing, and obviously the issue of lead dislodgement. So subcutaneous ICDs and extravascular ICDs have really offered us a lot of value. And you know who agrees with me that these are amazing devices? My opponent, who is the lead author, or the final author in this paper, which just came out I think earlier this month, about periprocedural outcomes from the post-marketing study of the extravascular ICD. And so this is published, The Preliminary Enlightened Results. And I believe also there may be an abstract that's being presented by my opponent tomorrow regarding this subject. And actually he's on a number of different papers. Here's one just looking at adoption of the extravascular ICD and SICD in the Dutch cohort. So this is a somewhat busy, and I apologize for that, but this is a figure from Heart Rhythm 02 that was published a couple years ago looking at the SICD versus transvenous ICDs. So this is from several years ago, so it's pre-extravascular ICD. And this is showing factors influencing selection of the SICD versus the transvenous ICD. And I think it goes without saying that the vast majority of these are falling on the side of the SICD. So limited vascular access, congenital heart disease, prior infection or risks for infection, things like immunodeficiency on dialysis, young age, our young patients who may need multiple transvenous leads during their lifetime, like the patient I presented to you, hypertrophic cardiomyopathy, channelopathies, again, women. Women are actually at higher risk for transvenous lead complications compared to men. And then the cosmetics issues, right? So all of these factors fall on the side of the SICD. And then if you look at favors transvenous ICD, for the most part it's limited to need for bradycardia pacing, which is obviously important, or CRT. And then if we're just talking about the SICD, then if you really think a patient would benefit from anti-tachycardia pacing, that would favor a transvenous device, or failed ECG screening. But now we have extravascular ICDs, right? So do those things really favor going to a transvenous device compared to an SICD? Or do they really favor going to an EVICD? So then I sort of made some modifications to this figure. If we think about factors influencing selection of extravascular ICDs versus a transvenous ICD, well, all of those things that we were talking about with regards to an SICD still favor an extravascular ICD, right? The vascular access, risk for infections, cosmetics, whatever, all of those also would favor an extravascular ICD. And then when we think about what favors the transvenous ICD, again, I already marked off need for anti-tachycardia pacing or failing screens because the EVICD, those aren't issues. And then you could also argue if one of the major limitations to the extravascular ICD is a prior sternotomy, then does that really favor a transvenous device, or does it favor actually going to a subcutaneous ICD? So going back to our patient. So the patient I presented to you, as a reminder, she was 51 years old, peripartum cardiomyopathy. She had a single-lead, dual-coil transvenous system that was put in in 2007, and now it's fractured. She's got vascular occlusion, she's got tricuspid regurgitation, and she's referred to me to figure out what to do about all of this. So shared decision-making, really important for this population to discuss the correct things to do. And what she elected for was removal of the entire system to limit her risk of complications from that abandoned system, and placement of an extravascular ICD. And her logic for why she wanted the extravascular ICD, if you recall, she'd received successful anti-tachycardia pacing, and so she did not want to have a device that would go straight to shocks. And also, the smaller device is appealing. So these are some images from her CT scan. You can see the artifact from the existing transvenous leads, because this was obtained in preparation for the extraction. And you can see on the lateral, her heart appears to be quite close behind the sternum. For those of us who implant these devices, this is not a bad thing. This is actually a good thing. You can almost always tunnel these leads successfully despite that, and you end up getting really nice sensing, and the lead is quite stable. And so she did undergo extraction of that entire system. She had placement of the extravascular system with no problems, and this is obviously her X-ray of that position. And this is from her defibrillation testing. So we induced VF, and you can see she converted easily and well with a single shock. And then finally, for those who do extraction, tricuspid regurgitation, when it's caused by a lead, usually does not get better with extraction. In many cases, especially if the lead is chronic, it does not improve, and sometimes the extraction can make it worse. But in this patient's case, her tricuspid regurgitation actually did improve somewhat. It did not resolve completely. And she remains asymptomatic and is much happier with the device location. So this is an amazing outcome for this patient, right? She's 51 years old. She has a system that's going to protect her, and she's not at all of those risks from the transvenous systems. And so, in conclusion, extravascular devices are the future, and transvenous devices are the dinosaurs of the past. Dr. Mason, thank you very much. I'd like to invite Dr. Lucas Boersma to the stage, cardiologist at the Antonius Hospital in Nieuwegein, the Netherlands, and he's also a professor in EP at the University of Amsterdam. Lucas, fire away. Thank you. And thank you, Pam, for an excellent job. It makes my life easier, too. Let's see if this works. Yes. So my job today is to convince you of the fact that transvenous ICDs are the gold standard, and that extravascular ICDs are just gimmicks. Well, gimmicks, I think, is a strange word. So I'm not going to go into that and the semantics of that, but I'll at least try to show you a little bit more about transvenous ICDs and my disclosures. So when I first was invited for this debate, I thought, wait a minute, what's going on here? This is confusing. I indeed am involved in a lot of things concerning SICDs and EVICD, so I was a little bit surprised to be the protagonist of the transvenous ICD. And then I looked at the title and I saw dinosaurs of the past. What is Pamela Mason doing here? You have these apps where you can make people look old, but as you can see, I'm alive and kicking, I'm not that old. So let's take a step back here and look at transvenous ICDs. And I asked Chet GPT. So there's over a million transvenous ICDs that have been implanted worldwide. And this goes back decades, four or five decades. And non-transvenous ICDs, I put a little bit wider definition of SICD and EVIC as non-transvenous ICD. They are the new kids on the block. They are here for a couple of years for the EVICD and let's say 10 years for the SICD. So they are really novel technologies. And when you look at the uptake of these novel technologies, it's not that great. These are data looking at uptake of the mostly SICD because this is before the EVICD was really marketed. And you see that the SICD, despite all the good words that Pamela said here about the SICD and EVICD, their uptake is not that big. So there seems to be some resistance in the uptake and there are obviously reasons for that. The biggest reason is that we all know transvenous ICDs for these four to five decades. And this is a slide you may know from Heart Rhythm Society. Transvenous ICDs have saved lives for over decades. They perform very well. These are slides looking at primary and secondary prevention indications. 40 to 50% of patients receiving appropriate therapy. So this transvenous ICD therapy seems to work very well. And there are indeed issues, as you pointed out in your particular patient. Real-world transvenous leads do have issues with performance sometimes. And sometimes the patients survive longer than their transvenous lead. This is true. This happens. And especially we had these issues with some newer models, the RIATA and Sprint Fidelis where we tried to have these smaller leads which backfired on us and we had issues with leads that had to be replaced or new leads had to be put in, which really led to morbidity. And indeed, when you look at studies that looked at the SICD, for instance, this is a study, the ATLAS study, looking at lead-related perioperative complications comparing transvenous to SICD. You see that 500 patients were randomized and indeed the lead-related complications were 92% lower for the SICD. But if you only look at things that are typical for transvenous lead complications and don't take into account things that are typical for SICD or EV lead complications, yeah, then you're stacking the deck. Then it's logical that you only see complications for transvenous leads and no complications for non-transvenous leads. So I don't think this is a really fair comparison. I think Praetorian, Ranald Knops here, did a better job looking at device and complications, larger than only lead-related complications. And he was indeed able to show that although in the primary outcome of Praetorian there was no statistically significant difference between device-related complications between the transvenous ICD and the SICD, when you looked at these complications, indeed there was more impact of transvenous lead complications with regard to things like infection. And now there's even a late breaker that we saw yesterday from Luisa Oldenortkamp. We've also been working on Praetorian for a long time. Now we have eight-year follow-up and you see that indeed these curves separate. If you wait long enough, you see that transvenous leads are doing worse than the SICD leads in this particular case. But then because of the device longevity, which is really shorter for, in this case, the SICD, you see that you get a lot of device-related complications when you go for lead, or sorry, for device exchange, box exchanges. So then the SICD actually catches up a little bit, what you see here. So I agree that placing leads outside of the vasculature may avoid unnecessary complication. I've actually published on a lot of these things as a co-author. But on the other hand, not every patient needs pacing. So indeed there may be a good reason why we have these SICD and EVICD devices. But let's not get too enthusiastic. The EVICD, there's now two and a half thousands of these devices implanted in the last year and a half. If you compare it to the one million transvenous ICDs that have been implanted over 40 years, that is a big difference. So we should be careful to interpret the data that we have from the EVICD. And there's only three larger publications, one of them indeed in HeartRhythm, which was recently published, and the poster that you can see tomorrow. But it's really a limited experience. And if you compare these data and you look at the EVICD and you compare it to the transvenous ICD and also the SICD, you see that the major system or procedure related complications were actually pretty good for the EVICD, but also in the same range as what we see for the SICD and the transvenous ICD. So it's not as if this is a truly very big difference depending on how you look at it and depending on which complications you take in your endpoint. And everything has to do with the lead. And although Pamela has shown that you can very nicely put that lead under the sternum, and we know that you can do this safely, it's not as easy as people think. The lead placement is crucial to have good sensing, good defibrillation, and if you don't get good placement, you might end up in the pleural space, either on the right or on the left, and you could also hit the pericardium. That doesn't happen very often, but it's a risk and it's also not something that is negligible. When we look at the EVICD trial, the IDE trial, there were system revisions after the implant which had to do with the lead. There were lead dislodgements and there was even with a prior version of the lead, lead fracture. So lead related issues are not unique to transvenous ICDs. They also exist in extravascular ICDs. And it led to repositions of either the lead or the generator or sometimes even removal of the generator. And removal of such devices, I apologize for the quality of the slide, although it was feasible in almost all the patients, it was not easy in all these patients. And in two patients, there was actually a failure to retrieve everything, and this happened early on. And you can imagine that if these leads are in for five or 10 or maybe 15 years, it may not be as easy to get these leads out. And we don't know yet what the long-term consequences of that is going to be. Another important part, I think, is inappropriate shocks. What we've seen from Pretorian again is when you compare the SICD to the transvenous ICD that the SICD had more inappropriate shocks in comparison to the transvenous ICD. And this was mainly due to things like T-wave over-sensing and over-sensing of slow VTs. Since then, the SICD has been able to solve many of these issues by involving dual-zone programming and smartpass algorithm that took away a lot of the over-sensing, bringing this down into the same range as what we could expect from transvenous ICDs. But for the EVICD, that journey has just begun. When we look at the inappropriate shocks of the EVICD, it's actually not, it's not negligible. It's about 17% over the three-year follow-up. And obviously, this has a different reason. Here, P-wave over-sensing and myo-potential over-sensing is an issue because you put that lead on the epicardial surface on the right ventricle and also the right appendage can be there. And although there have been mitigations with the P-wave over-sensing algorithms and we avoid these P-waves when we implant them, it's still something that we will need to see in the follow-up registries like Enlighten whether we are going to get rid of these inappropriate shock rates. And then again, I think the pacing is relevant. This is the APPRAISE ATP trial, looking at ATP to avoid shocks, showing you that single and dual-chamber transvenous ICDs are indeed very, very important to save the number of shocks that you get by allowing ATP. And indeed, the EVICD has a similar ATP performance than what you see from transvenous devices. You can very nicely, and 77% of all the ATP or VT episodes, ATP worked. But in some patients, ATP was turned off because they had a sensation of pacing under the sternum and there still is no bradycardia pacing with the device because of high thresholds that would drain the battery very, very soon. The same can be said for the subcutaneous ICD. Although it's very reliable as a defibrillator, it is not a pacemaker. And high pacing thresholds and the device design do not facilitate the option of either ATP or brady pacing. And that has been solved by an elegant new solution, making a leadless cardiac pacemaker that can communicate with the device that offers both bradycardia pacing and offers ATP. And here's an example from one of my own patients where ATP worked very well, but this requires a second device. Now you suddenly have to implant two expensive devices. So that's also not a very attractive solution. And then there's the other thing. Many dinosaurs have a habit of coming back to life. Pacing is obviously something that many, many patients need. Many of our patients that have need for an ICD also have need for pacing, either as a defibrillator, where it also, a single chamber device can offer ATP, brady pacing in dual chamber pacemakers, or ICDs, and the biventricular devices for resynchronization therapy. So this offers the full spectrum of possibilities, defibrillation, ATP, and also pacing if needed. And if anything, I would say that conduction system pacing is the present and the future. This is something that's really hot and happening in our world. Everybody wants to do conduction system pacing. And although this is something that is mostly preserved for patients that really need pacing, it's also not uncommon in patients that need a defibrillator. This is work from the lab of Har and Bury showing that with standard defibrillation leads, you can already perform conduction system pacing by putting that ICD lead in the left bundle branch area. And then there's a new lead design. There's a new wave of leads. This is the Omnia Secure lead, and you've seen some work of that last year at HRS Late Breaker, and there was a Late Breaker also yesterday, showing you a very nice and robust lead, 4.7 French lumenless lead, showing a low rate of complications, showing high rate of defibrillation with that new lead. So this is sort of a new era for a new type of transvenous leads. And also, as you may have seen yesterday in the Late Breaker, you are, it's able to perform left bundle branch area pacing. Again, highly effective for defibrillation and also being able to perform pacing. Durability of this lead also seems to be excellent. So there's a new era. The dinosaurs are in fact, I would say, coming to life. So I will stop here and conclude that I think that transvenous ICDs have been around for four to five decades and offer the full spectrum for bradycardia pacing, resynchronization pacing, ATP, and defibrillation, and they have performed very reliable. And I would say that lead and device-related complications are not unique to transvenous ICDs. And that extravascular ICDs, although they are nice, they lack the full spectrum of these pacing options. And sometimes it may be uncomfortable, and you sometimes may even need to put in a second device for brady pacing, and that is an expensive option. So I'll stop it here and give Pam a chance to come back. So thank you, Lucas. I know how painful that was for you. And so we'll now have Dr. Mason have five minutes of rebuttal. I should say in passing, I'm not supposed to take a side either way because I was one of the original investigators for the dimes that we used to put these in by a sternotomy. I'm not sure if any of you remember those things, but anything's an improvement from my standpoint. Alrighty, so we're in an interesting space right now with pacing and defibrillation. I always said to my fellows, when I was a fellow, we had IS-1 leads and we had DF-1 leads. That's what we had, that's all we had. That's what we put in in everyone, and we really didn't think about things like tricuspid regurgitation because there wasn't a whole lot we could really do. But things are changing, and we're specifically talking about extravascular ICDs, but really there's a whole paradigm shift in as far as thinking about ways to do pacing and defibrillation without these transvenous leads. We're all familiar with leadless pacing. I'm showing here the Medtronic Micra, so they have ventricular pacing, they have atrial sensing and ventricular pacing. Now Abbott has the AVERE, which is atrial and ventricular. And so you can have AV sequential pacing with an entirely leadless system. And this has obviously been shown, but this is actually a video that's from the appendix from the New England Journal paper looking at the Boston Scientific Empower. And so these are patients that have subcutaneous ICDs, and they then get this leadless pacemaker. All of the current SICDs that are implanted are backwards compatible with this, so you can implant this device. And essentially the SICD acts as sort of the brains of the operation to detect and direct that leadless pacemaker in order to provide anti-tachycardia pacing. So now we have a system that's entirely transvenous where the patient has a defibrillator, a ventricular pacing, and the ability to have anti-tachycardia pacing. And then here's another product you may or may not be familiar with. This is the EBRY CRT. And this is a device that requires a co-implant, so there's something placing the right ventricle. And then using a transducer with a tiny little electrode implanted directly in the left ventricle, it is able to essentially provide some form of left ventricular pacing. So if you take a step back right now, as we are in 2025, it would require multiple vendors, be horribly off-label, and a lot of creative programming, but you could theoretically create a biventricular defibrillator that's entirely leadless. Now, I'm not advocating for that because it would require multiple vendors to be horribly off-label and there'd be a lot of creative programming. But my point is, we're kind of almost there. It is not gonna be too, too long before we have these devices that are essentially entirely leadless and are able to provide these therapies for patients. We are at an interesting intersection, right, with the whole conduction system pacing and as was discussed, the OmniSecure lead that was presented yesterday. But we're gonna have a lot of options for our patients and with many of these products, we don't know exactly how they're gonna play out for years and there's a lot we don't know as far as how we're going to get these things out and what do we do when the battery runs down. But we're in a really interesting time, like a really exciting time for pacing and defibrillator therapy with a lot of different options that our patients historically have not had and I think there's gonna be a lot more to come. Let's see if this works. So I knew you were going to talk about these leadless things as well, and I already told you that dinosaurs are coming to life, and you're acting very surprised. But it's not really a big surprise, obviously, because dinosaurs have a habit of coming back, you'll find out. And it's strange that you're so surprised, because actually, you're involved in all this stuff. Talking about me. You're involved in all this stuff. You're on the steering committee of the leader trial. And you even promote this, and you have nice posters. You're living in two opposite worlds, so you have to choose. I'll leave it at that, and probably we'll have more time for questions. Well, thank you very much, Lucas, Dr. Mason. We have some questions from the audience. Everyone, if you want to send in more questions, please feel free to do so. I think this could be best answered by Dr. Mason. How do you handle the challenge of getting insurance to approve EVICD in the US? Here's someone who has a 42-year-old hypertrophic cardiomyopathy patient with documented non-sustained VTs and multiple relatives with sudden cardiac death, and I can't get insurance to approve it. What would be your advice? Yeah, I mean, I think that for those of us who are in the United States, this is a chronic challenge that we're having to deal with, and every time there is a new product, we deal with this. We dealt with this with leadless, we dealt with this with subcutaneous ICDs. For the most part, I'm not having issues getting subcutaneous ICDs covered at this juncture, but extravascular ICDs, we still are. I do think that there is value in trying to push through with the peer-to-peers, filing the appeals. Sometimes they go nowhere, but I do think that the companies will eventually listen when they're receiving enough appeals. You know, I think our societies are starting to engage more with advocacy on our behalf. The ACC, I know, is engaged. I'm on the EP Council, and we're trying to engage with insurance companies, but it can be an ongoing challenge. So if you wanna stay extravascular, then currently the option, if there's no insurance, is to go for an SICD. Is that what I understand? We will occasionally still get pushback from some insurance companies for SICDs as well, but they are, in general, more likely. I have had patients where they didn't wanna pay for the extravascular ICD, but they would pay for a subcutaneous ICD. I guess I can also address that, since I represent HRS to the rock, that well-known institution that's responsible for all your reimbursement. And the newer device, as presented by Paul Friedman at ALP, Friedman at ALP is not yet up for grabs. And I should say, just by way of instruction, that every time you introduce a new technology in the United States, you may open up very exciting opportunities for patients, but at the same time, you open up a can of worms in terms of previous technologies. Because the more codes you create, it will invariably create a revaluation of all your previous systems, which invariably leads to a down valuation. So be careful, at times, what you wish for. What my recommendations would be, or to consider doing it through the subcutaneous ICD platform in terms of your coding. I still remember when we presented that to the rock committee, and they said, oh, this is a simple device. You know, the manufacturer has it on YouTube. I can put it in. And this was an orthopedist. And so, it's a very complex answer to that. All of these, I think if you have any further questions, you can refer it on to HRS, to the Health Policy Committee, because they can give you some advice. And some of these are really insurance, private insurance specific, et cetera. But I think an important point is, there are insurance companies that right now will not cover it. So, I don't have a magic answer to that. I don't think there is one. And does Medtronic have a role in that, for compassionate use, that you could apply for a device free of charge? Is that common? Is that common? I don't know, but. Dr. Burke? Thank you. That was really outstanding review on both sides. Very nice, thank you. My question actually gets to Lucas's slide, and which always amazes me at how little adoption there's been on the subcutaneous defibrillator, despite what was gone through in terms of indications and types of patients that would favor. And this isn't to anyone particular on the panel, but if we could maybe just get a discussion about that, because it really bothers me. So, I mean, and that's open to everybody. Well, I think we are so used to transvenous ICDs that we've taken every downside of transvenous ICD for granted. And now there's a choice, but many people try to avoid the downsides of transvenous ICDs. I mean, I've been a little bit protective about it, but there are certainly downsides. But we're still teaching all our residents and even people in training, we teach them how to go into the venous system. Everything is intravascular. So as long as we keep teaching them that that is the way to go, there's never gonna be a paradigm shift where people say, hey, this is not the right way. We should stay out of the heart if we can. I think that's a big thing that has to do with teaching and has to do with acceptance in the community that there is a choice now and that you cannot ignore all the downsides of transvenous ICDs. So if you don't need a pacemaker, then don't implant a device with leads. I think inertia is a really powerful influence. I think that's a lot of it. I do think there's some other subtle work in play as well that has to do, at least in the United States, as far as contracting with different vendors and what vendors people have access to. I've heard people discuss issues about general anesthesia access, right? If you're used to doing all your transvenous devices with conscious sedation, many people prefer to have general, you don't have to. I mean, there's different ways of doing this, but a lot of times people prefer general anesthesia. For the extravascular ICD, I do do them. I think it's a great device and I think it's very safe to implant. You do need general anesthesia. And when you start doing this, it is labeled that you have surgeons, not just available, but scrubbed into you for the first five cases. So I think for that device, I think people find there to be some barriers in starting programs. You're right, but some of these barriers are not so barrier at all. I mean, we've started doing this as soon as we went outside of the IDE trial. We started doing this without the surgeon and I thanked him for being a partner with me in the first cases, but then we started doing that outside of the surgical operating theater and the last 10 we've done without general anesthesia. So it's just a matter of learning and creating more awareness and creating more science to show that you can do this and that you can overcome a lot of these barriers. I have a more practical question here. Implanting substernally, how do you avoid injuring the lungs? Who wants to take that? Injuring the lungs? You know, the two things that, when you're tunneling the lead, it generally goes pretty easily. The things we worry about is running into the pericardium or ending up in the pleural space. I think injury to the lung is incredibly uncommon, even if you end up in the pleural space. I mean, I've fortunately not had much in the way of issues, but for folks I've talked to who've even ended up in the pleural space, I think you simply remove it and it's unlikely to cause any sort of pulmonary injury. I certainly can't say it hasn't happened, but I think ending up in the pleural space, you want to recognize so you can move the lead, but I think it's unlikely to actually injure the lung. And do you think there's any value of doing any pre-diagnostic tests like a CT scan to check for kissing lungs, things like that? I usually review a CT scan before it. I would say more than half the time I don't actually get a CT scan because if you actually look in patients' medical records, the vast majority of them actually have a CT scan you can look at. I mean, there's gonna be some variability. When we first start doing these, I think a lot of us kind of have this idea, if there's a lot of space between the sternum and the heart, that's a good thing, right? I have lots of room, I'm not gonna run into the heart, this will all be good. And I will say now that I've looked at a lot of these CTs, it is shocking how much variability there is from patient to patient in the distance between the sternum and the heart. I've seen patients where it looks like it's right up against it, as the case I showed. I've seen patients where it looks like it's several inches worth of space between the sternum and their heart. So as far as reviewing the CT scans, yeah, I kind of look at it and get an idea of where the lungs are and if they're kissing. I can't say that I've not tried. If it looks like the heart is right up behind the sternum, you can almost always find a pathway to get the lead in. The thing that actually concerns me the most is when you see lots of space. Because when you have lots of space, I feel like that's sort of a risk for dislodgement. I think it affects the sensing and the stability of the lead. In theory, when you get your finger in that substernal space and you tunnel the tunnel tool up, you press away the pleura. And then there's a question about the extractions. And I'll defer that one to Lucas. What do you think about the extractability? You talked about it already a little bit for short-term and long-term. And infections have not been an issue so far. But do you expect if the lead dwell time is longer, that that might change? I think these are excellent points. We don't know yet. What I showed you is a paper that was published in Europace last year on 29 cases, where some of them were actually sort of immediate explants because of superficial infections where we didn't want to get any into trouble. So these were very, very early explants, not even extractions. So only a very few have been extracted beyond a year. I think the longest one in that series is 28 months. So we don't really know about long-term. So far, the infections that we've seen have been treated just by getting the device and the lead out, which usually doesn't need a lot of traction or force. Very rarely, you're unable to get it out by just simple traction is usually enough. We haven't seen any mediastinitis or stuff like that. That's really something different. That's really when you do a stomatomy, you have the full sternum open, then you can get very nasty infections. So far, there is no case, as far as I'm aware of, in these 2,500 that have been implanted where you see this type of nasty mediastinitis. That doesn't mean that it couldn't happen. Yeah, there's always gonna be exceptions, and there's gonna be new patient selections. There's one of the operators is now testing it in patients after stomatomy. Maybe that could be a different situation in a different area, but that substernal space actually is devoid of a lot of stuff that can really become infected and can be very harmful in the way we're implanting it now. I do wanna emphasize that this is obviously not a binary situation, okay? It's not all or none. This is all based on patient-directed therapies, and I think understanding Dr. Burke's frustration, the whole aspect of pacing probably has a major thing to do with the selection of devices, especially in the days of cardiac resynchronization therapy, and though you can go around it by putting in a leadless pacer, for example, but if you have a young patient, then the right ventricle essentially becomes a landfill because not everybody, in fact, most people are not extracting those systems, and you can do the WISE system, which in fact is very complex and ornate, but again, I think we've all recognized that the lead is the weak link in all of this. I mean, I vice-chair the whole consensus document on lead management and extraction. It was very painful, and even though we, for example, in your case, we discussed tricusporegurgitation. It's been very disappointing that when you extract those leads for that specific purpose, the results are not as good as we had hoped. Infection is a clear-cut scenario, but it's not all 100% one way or another, and I think that anybody who says otherwise is a dinosaur. I'd like to start one of my favorite discussions. Who needs ATP? And I noticed in your case, Dr. Mason, that your patient received appropriate ATP, but the last ATP was three years prior, and after receiving the EVICD, which has the ATP on board, no ATP was given, so my question is, what is your approach to someone who has previous VTs, and how often do you really think that there's an actual need for that ATP? And then on top of that, is ATP the best treatment for VTs? Okay, yeah, that's like an hour-long session, yeah. That's like an hour-long, no, I mean, this is all legitimate, right? And people who were huge advocates of SICDs, their point was in the era of long detection times and higher rates, the reality of the matter is a lot of these patients that we declare to be successful ATP recipients, would this have just terminated on its own? Is it really needed? Yeah, from a primary prevention standpoint, especially in people who are not in ischemics, when people say to me, like, oh, well, my patient needs ATP, I mean, I think that's pretty overblown. You know, when we're selecting devices, I can't say that the ability to give ATP is one of my primary considerations in most patients for primary prevention, regardless of what their underlying diagnosis is. The patient I presented to you, she had had ATP in the past, and that did influence her decision-making, because having received ATP, that was, quote, successful, versus being shocked, she'd obviously prefer ATP, so. So, now, if you would have, so if the Empower device would have been approved, would your approach have been different? And how would you, in the future, think that you would make that decision? It's quite a difficult question, but. I mean, it's the same thing we say all the time now, right? It's shared decision-making. You have to talk to these patients about it. I will say, you know, it's interesting, when I've been doing SICDs for over a decade, EVICDs since they first came to market in the US, and, you know, as electrophysiologists, you know, I think a lot of people, when they first heard about the EVICD, were really overwhelmed by this idea of thinking that you're gonna put a lead retrosternal, like, is this safe, we're not surgeons, what are we doing here? But patients don't think about things like we do. So, when we first started doing the EVICD, they didn't think about things like we do. So, when we first started doing this, and you go to the patients, and you say, okay, well, there's these two devices, and this is the battery for one, which is twice as big as the other one, and the EVICD battery lasts a lot longer, right? And this device can do ATP, you know, the patient's kind of like, well, why would I do this SICD instead of the EVICD, right? And I don't have a good answer, you know, when we first started doing them, I didn't have a good answer other than, well, I'm kind of scared of putting a lead behind the sternum, right? I mean, like, which, and patients don't think about things in that manner. And I guess the real answer is, of course, well, this device has only been out for a year or so, or it's relatively new, and we don't have a lot of information about removing a lead. Yeah. I would say that things are not so binary as you already mentioned. I mean, these therapies are complementary to each other. I mean, you have an SICD, and you can implant, hopefully shortly, when there's FDA and CE approval, now you can start implanting an Empower device, or if you want to have ATP. But to your point, I mean, if patients have a lot of VT, then you do a VT ablation. That being said, not everybody will have a good outcome of VT ablation, or some people may be too weak to undergo a safe VT ablation. So it's not either or, it's probably a combination of all these things. And yeah, I mean, it's interesting that now with the modular approach that we now have, let's say a pacemaker in the ventricle, but now we can come into a different area. So if a patient needs pacing, are we gonna put that thing in the right ventricle, or do we need conduction system pacing? So I think what you told us is true, that it's an interesting timeframe, because a lot of different options are coming to market. But it's also a very confusing timeframe, because how do you choose for your individual patient, what would suit best, and predicting the future, I always understood, is the biggest problem in the world. It's very hard to do that. And so it's very hard to understand what patients will suffer from in the next five to 10 years, and how to choose. Yeah, and I think that that is, it is said that the only thing we can't predict is the future. And again, I think the fear associated with that, the people in the UK for sick sinus syndrome, for years put in AAI pacers. In the United States, we're much more cautious, put in dual chamber because of that progression in certain patients with sick sinus to heart block. So while you're at it, why not put in a second lead? And so because of that fear, that might. Is it known when the EV-ICD will be Bluetooth compatible? That would require a new platform, and that new platform will be there in a couple of years, as far as I understand. EV-ICD lasts twice as long. Is that consistent with IFU, with all functionality enabled to compare like for like? These are quite technical questions. Twice as long compared to what? Probably to SICD. That's not completely true. I think currently SICD is 7 to 8 years, and EV-ICD is around 12 years, so it's not completely twice as long. And that's with all the functionalities being there. Now I would say with any ICD, if you get a lot of shocks, that will probably drain the battery prematurely, but that's true for any ICD. This is on average 12 years. So perhaps I want to advise a little bit on how we counsel patients. I think one of the important things to always add when you counsel a patient is the robustness of the data that you have that promises them what will happen to them during follow-up. So the known inappropriate shock rate of, for instance, the subcutaneous ICD versus that of the EV-ICD, that algorithms are on the way, but there's no promise yet. So that makes the decision a little bit more difficult. But having said that, I have the same experience that you have if you show the device, especially to younger female patients, that it's for them a no-brainer. And indeed, it's what you say, that where we are a bit scared to perform that procedure, the patient, they think that we can do everything very easily. So that is also my perception. In the counseling, you have to stick with the data that you have, and it's a bit easier to counsel on data from transvenous ICD, millions, SICD over 100,000, and EV-ICD, what did you say, 2,500. So I think that is important to realize, that what you promise your patient comes with these reservations. And again, I guess the other thing to emphasize is that we do have to be very careful what we say, whether it be to the patients or in more public arenas such as this, because there are, dare I say, people or ears that are listening. And I'm not just talking by drones, but whether they be insurers, whether they be the legal community, you say, well, it's a no-brainer to do this, or a no-brainer to that, is the practitioner therefore at fault if he picked the device that was not the no-brainer when there were compelling reasons to consider it that were not explained. So we have to be, I think, cautious until the truth becomes evident, which it may never become until well after the fact. Well, I think that's a nice closure. There are no more questions in the app. I'd like to thank both of the speakers for their contest, and if there are no further questions from the audience, then this is the end of the session. Thank you very much.

transvenous ICD

extravascular ICD

cardioverter defibrillator

ICD debate

EVICD advantages

lead fracture

long-term reliability

leadless pacing

shared decision-making