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Inside EP: Insights From Clinical Decision-Makers ...
Panel Discussion
Panel Discussion
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So let me let me ask the first question, and I want to go down the line. CRT, his bundle pacing, LV, left bundle pacing, do you think ultimately it will be one size fits all? Do you think that there will be different pacing modalities for different people? And will we be able to decide before we go into the EP lab who's going to get what? So Shiv, why don't I start with you? So I have a, so our approach I think is going to be, it's not going to be one size fits all. There's going to be a little bit of customization, so there's going to be a, our view of this would be is better case selection, but have a small set of tools, you know, a spectrum of devices, if you will, especially in lead technology. And what is going to be very fascinating is case selection and programming. So we think that there has to be flexibility in terms of the actual tools that you have and the leads that you use. But there's going to be a lot more information that is going to be pre and post procedure. Chad, what do you think? Is it going to be, is it going to be, oh, you, sorry, oh, I'm sorry, I'm sorry. So his bundle pacing, standard CRT or LV lead pacing, is it going to be one size fits all? Or are these going to be available to distinct groups of patients? And are we going to be able to decide a priority before we go into the EEP lab who's going to get what so that we are prepared? Sure. Sure. That's a great question. I think the whole field is kind of mulling over that question. I think there would be individualized phenotyping to decide what the best strategy for that particular patient needs to be. You know, CRT treats patients with intraventricular conduction defects, left bundle branch block, as well as non-left bundle branch block with a varied response. And we kind of understand where it works, where it doesn't work, because there have been a bunch of randomized clinical trials in large populations that helped us ferret out those responses, response strategies. His bundle, if you look at it, and I'm going to show some data on one of the new studies related to that, you know, there's been really no significant randomized control trial of more than 25 to 30 patients with any long-term follow-up. So I think there are a lot of things really need to be evaluated on that front as to how durable it is and whether it will become a part of our elementarium. Left bundle branch block pacing, I think, has more viability. And I think it has more viability because if you look at the future, the contest is going to be between individualized pacing strategies and leadless pacing strategies. And I think the whole field is moving towards leadless pacing strategies. And at this point in time, I'm not sure I can figure out how a leadless pacing strategy will work well with his pacing, but I can see how a leadless pacing strategy will work well with left bundle branch block pacing. So I would state that it's not going to be a one-size-fits-all strategy. I think we'll need to individualize phenotype patients. But the beauty of the strategies available now are that if you can't get a CRT into a particular patient, you have two other bailout methods. You can put in a his bundle lead or you can put in a left bundle branch block lead as a bailout strategy. But over time, as we get used to these three different technologies with randomized studies, we'll get a better sense of what would be preferential in certain patients. And, David, let me ask you, I mean, we're going to need to sort of getting back to that early question. Do mortality trials to show one versus the other or are we going to have surrogate endpoints? How do you see this playing out? Yeah, so I'm in the mode of being both an early adopter, yet a strong believer in evidence-based medicine. Of course, in this early emergence of alternatives to CRT with left bundle pacing and his bundle pacing, we don't have any long-term data. We certainly don't have any data on responsiveness of the heart failure population to that intervention. So I'm using that preferentially in people with preserved ventricular function and heart block who need a ventricular wire and I say, you know, it just looks better on the EKG if I pace their left bundle or pace their his. But we've had issues. We've been doing this, what, three years now and we've had threshold rises and lead-related issues. And the tools have been very limited to date. Things are just now opening up. So I think we need to learn more going forward. And yes, I think ultimately this will need to be subjected to a large trial to really know the right answer. So I'm going to switch it up a little. For those of you, this is Dr. Brad Knight. He's the director of electrophysiology. He's also my boss, so I'm going to go pretty easy on him. But Brad, I know you've been really instrumental in the development of the sub-QICD. What do you see as the major limitations to what's available on the market today and sort of if you had to predict the future for ICD therapy, where do you think it's going? I think the subcutaneous or extravascular options have huge advantages to young patients. I saw two patients yesterday in clinic that I screened for the sub-QICD. One was in his 30s. One was in his 40s. The 40-year-old had a 15-year-old Fidelis lead that was coming time for a generator change and had it for secondary prevention. So I think the hypothetical advantages of not putting in an intravascular lead in young patients is a huge driver for me and having been involved in a lot of extractions to push that. Having said that, we do run into problems that didn't exist before with the sub-QICD, and I think people have written some interesting papers recently on the pros and cons of the subcutaneous device. But we're troubleshooting issues we didn't have before. We thought it would be a perfect sensing system because it was extravascular and could look at things much like an electrocardiogram would look at. So I push it, but we deal with T-wave over-sensing. I think algorithms have improved to minimize T-wave over-sensing, whether it's how we screen for patients or whether it's the software. We're now putting these in more intramuscularly between under the latissimus, and I think that may have led to some more mild potential over-sensing. So it's a whole new field of sensing and troubleshooting issues that we didn't have. But I think it's the way of the future. It doesn't make a lot of sense to put a lead inside the heart if you don't need to. So Andrew, you told an interesting story about emails, and I'll tell you a quick story. I never watched the show Homeland, and then one day I got about 30 frantic emails and phone calls from device patients because in the show Homeland, I think the vice president at the time had his device hacked into, and he was killed through that. So the issue of cybersecurity and how we protect implantable devices sort of came to the forefront. So how do you deal with this in Canada? Is this a concern? What do you think that the answer is, or is this overplayed? Yeah, that's a really good question. The button. Yeah, the button. Here we go. Yeah, green light. That's better. That's a very good question. So first of all, this is the area of a high degree of hysterical behavior. No patient has ever had their device clinically hacked and had any clinical event happen. Period. I just gave a talk on this, reviewed the literature because I'm not a particular content expert. So second thing is there was this huge question around reliability and cybersecurity that happened four years ago with Muddy Waters creating speculation around Abbott platform devices and so on. And there is no question that the public, including patients, want to be aware of what measures are taken in this situation. There are a whole bunch of encryption and surveillance and internal, if you like, hackers hired by the companies that make the, or the people who make the hardware and software to try to find vulnerabilities in the software of these devices. And the vast majority of that expertise is actually in-house, which is actually why it's not a clinical issue. There is always a theoretical possibility because of levels of encryption, but also sophistication of hacking that you are vulnerable. And there have been instances, for instance, where devices have been found to be vulnerable typically by an academic group looking for software vulnerabilities. And then there's a gap with an advisory where they're theoretically vulnerable, and then the patch comes through. I think that's going to be the case because there's evolution of software until quantum computing changes this. So quantum computing will dissolve, if we really have functional day-to-day quantum computing, it will dissolve all of your banking and device security in a nanosecond. And I mean, I know that sounds crazy, but I can email me and I'll send you the podcast that's very interesting about quantum computing for dummies. That's why I could listen to it. And it's a very interesting description of how quantum computing that's conceptually in existence right now can get through any encryption algorithm literally in nanoseconds because those are built on a zero-one morphology as opposed to an unlimited state for any variable. I know it sounds sort of technical, but the bottom line is there's a generation of evolution of this that's both incredible but also scary. Brad looks like he wants to say something. No, no. It just got me nervous. So it sounds like if your goal was to sort of go after an individual, it would be very challenging to do that. I guess you were so committed, it might be easier just to sort of run them over, but... Yeah, put it this way. So the nefarious part of this is somebody who wants to, for instance, bring down remote monitoring, which would be a really meaningful, terrible thing, right? Whereas it is a lot easier to shoot somebody or run them over than it is to try to go after their particular device, which is why it's never a one-on-one attack. All of the actions have been system attacks that have been attempted. And so the vulnerabilities happen at the individual level, but the hackers are all targeting system attacks because that's what really matters. Jag, what do you think? No, let me get the green light on. So no, I totally agree. I think the fear factor is overemphasized, but I think there are two components to this that really need to be given due consideration. One is vulnerability of the device itself, that you can hack it, but the other is the vulnerability of the data coming out of the device. And I think as we're developing technology that is smartphone-friendly, like you have implantable loop recorders that patients can read out of, and I think as we start moving down the path of self-management strategies, which is what the future of medicine is, where I think patients will be able to acquire the data and be able to also use that data for changes that they need to make themselves. I think it's at that level of that data that can be accessed, and I think that's the area of cybersecurity that is much more vulnerable is after the data leaves the device. So obviously you can bring down remote monitoring, but you can also interfere with how that interfaces with electronic health records. There are answers to it. I think just like quantum computing on one side, you have a blockchain on the other side where you have these immutable ledgers of transactions, which again I think can enhance cybersecurity. Certainly something, you know, as the whole concept, and you guys know this better than we do, the Internet of Things, where all devices will be eventually interconnected, I think that fear of that data coming out and getting pilfered is much higher. Andrew? Just to add, there's no question that the physicians need, if you like, sufficient knowledge about this to be able to explain and walk patients through it, because they have understandable concerns and they're going to talk in device clinics to the nurses, technologists, and physicians about this and their risks and so on, so you have to have a response, even though superficially you could say it's not clinically relevant, it doesn't help to say don't worry about it. You have to explain it to patients. This is a great question. Do you feel like the physicians are getting the appropriate information from the device manufacturers in order for you to explain to the patients what you feel they need to know or what the patients want to know? In short, I would say mostly. So, for instance, when I talked about the Canadian Heart Rhythm Society, their device committee, what they're doing is they're taking the physician panel recommendation that comes from the manufacturers when there's a field action that takes place and they're digesting that into applying it within your own healthcare system, and everybody's healthcare system has slight variations and so on, but most of the time the field actions that come from companies has some estimate of the number of devices that are affected, the number of people who have had either evidence of the concern or have come to any kind of clinical harm, and those numbers are informative, and then they come out with some recommendations about what to do. They tend to be a little general and a little vague, and that's why sometimes another layer of this is what you should do with your clinic patients can be helpful from the physician perspective, but I don't think that there's a big gap, if you like, between the communication that comes after the regulatory and company communication to the physician providers and clinics. Since it's very tempting when we have an audience that's quite erudite from industry, perhaps it would be good to get some input from all of you. I think I have no compunction in stating this as a physician that I'm actually scared of the data that's coming out of all these implantable devices. There's actually a deluge of data that is coming out, and there are two problems. One from a scientific perspective, we do not yet have proper algorithms to look at long temporally long data sets that are obtained even for simple things like ECGs. There aren't good mechanisms to analyze a patient's electrocardiogram for a two-month window if every single heartbeat is measured. We simply don't have the mathematics and the strategies to do it. On the other extreme, and Dr. Segerman just asked a nice question from the audience, most of these engineers, especially software engineers, all of you are very, very talented people, and of course we love you. You over-engineer things. So there's too much information that comes out. So it's going to be very interesting to see what the industry, academia, industry, professional society partnerships would be, and how that is going to be shaped in terms of getting useful actionable information that we can work with. Because that, I think, is a huge problem, and we were actually very nervous when all these heart failure devices were going in, because almost there was a revolt in the EP clinic saying that we don't want to deal with this data. So it'll be interesting to hear thoughts from, of course, the panel members, Dr. Passman, and also members from this audience, because we don't get to address a group like this. Yeah. Let's hear. Yeah. You've sort of opened up a question I was going to ask around remote monitoring, really. I work with Boston Scientific. I've been a field clinical engineer, and now I'm involved with trial safety. And yeah, certainly internally, we sort of believe that it's going to be the best thing since sliced bread for looking at potential early recognition of heart failure. And obviously, as clinicians, you're wanting to sort of get into that phase as early as you can. But as you say, potentially a massive amount of data coming to remote follow-up clinics. And what do they do with it? What do they do with the alerts? What do they do with the amber alerts, the red alerts, as you say, the deluge? It's a problem we think has a potential huge benefit. But personally, having been in the field, I recognize it's going to be a lot easier said than done in terms of managing it. If you have ever walked through an ICU past the monitor bank, what do you hear? You hear continuous alerts going off all day, every day, with staff wisely walking by, okay? So there is such a thing as alert fatigue, and you make clinicians dulled to the severity or importance of an alert if there are just too many of them and they're coming to them too frequently at too low a threshold. Now what's the answer? You don't want actionable data not to make it in the hands of someone who can help the patient. But if the net-net is that they ignore that piece of information as well as, you know, life-threatening data that requires emergency intervention just because they're overwhelmed, then you haven't achieved your goals. And whether, you know, we can put layers of AI over this to steer the most important data in the sickest patients to our desktop, or whether we're going to just miss a lot of stuff like we're doing right now, I think time will tell. So I know Jag has a comment, and then Andrew, and then the good thing, we built in a lot of discussions and informal time to continue these conversations because they could go on for hours. So let me just start with Jag, Andrew, and then we'll move on to the program. Sure. So, you know, I think if you remember in 2005-2006 when remote monitoring was actually being initiated, most electrophysiologists had seizures, and you'd say, you know, this is not the way, we're not going to do this, we have to see our patients, and lo and behold, patients that we were seeing four to six times a year, now we see them once a year when they come in. So remote monitoring clearly worked. It clearly has a role, and clearly had a role in device function and malfunction and arrhythmias. Heart failure is a more challenging, you know, entity. There's a lot of complexity out there. And I think you can have the world's best AI strategy, but to develop the world's best AI strategy, you're going to require so many patients with so many outcomes and with so many numbers of patients to be able to actually configure something that may be meaningful. But I think until we get to that point, it is all about workflow. And it's about creating a workflow strategy with dedicated heart failure EP nurse practitioners slash MDs who are interested in that, to actually take it to the next level, and, you know, develop workflow strategies, understand where they give way and where they don't. But I think it has a role. It will eventually be the future. And I was just talking to Ramesh earlier this afternoon, that I think the future heart failure clinic visit, the transitional clinic visit, will be from home. It will be virtual care, censor-aided by whatever censor strategy there is, powered to some extent by predictive analytics or AI. But primarily, it'll be a clinician with a patient with some device data which is providing objective measures of where they stand. And it's going to be a period of time before we gain faith in that objective measure. But until then, there's going to have to be a physician or a clinician or a healthcare provider involved at every juncture. Andrew? It's really a comment that's quick. So this is not the age of enlightenment, right? We are in the dark ages, and there's a hint of light on the horizon. So what's happened is we've now got the ability to do it, but we don't know what to do with it. Like, we were sort of standing in front of the first wheel trying to figure out how we could apply this in terms of the scope of data. So this is a journey we have to go on to try to figure out how to use it thoughtfully and then try to balance the false negatives and positives and how humans apply this and what endpoints it links to. You know, and the only thing is, if you look at the accelerated pace in which data capability is happening, presumably the implications of the data will also evolve very quickly. And so, hopefully, we will commit to connecting the data capability to the clinical implications to try to get informative results. So one of the things that happens, and I see this as a bit of a harken to the Hisp on the left bundle conversation, is we jump to the appeal of new technologies without the discipline of evidence-based comparative medicine. So we need to connect those things to be able to make good decisions, because it will clearly have implications. But it's complex. Yeah, so closing remarks, Dr. Knight. Just a comment applicable to this topic is looking at it from the perspective of the physicians, and I realize that patients are really your customers, and that should be the focus. But just to share, you know, the life of a doctor as an electrophysiologist, you know, it's constant communication. So we can be called, we can have our office called, we can be texted. Patients now have our emails. We can get paged. We now are inundated with the EMR, which is the gorilla in the room here. So I would strongly encourage you to work with these EMRs. It's unrealistic to think we're going to be able to continue to log on to every single company's remote monitoring system to look at these alerts that we're talking about. So you know, I should, I'd get fired, but if I could open my Epic inbox right now in the last three hours, it's full. And there's probably patient questions there that are urgent. Some, you know, it's just like, I think David's comment about the ICU monitors is very important. So work with the EMRs to simplify it so that we can do our job to take care of patients more safely and effectively.
Video Summary
The panel discussion centered on various topics related to cardiac resynchronization therapy (CRT), his bundle pacing, left bundle pacing, and the future of implantable cardiac devices. The panelists discussed the customization of pacing modalities for different patients and the need for flexibility in device selection and programming. They also highlighted the importance of gathering more pre and post-procedural information to improve case selection and patient outcome. The discussion also touched on the potential limitations and benefits of different pacing strategies, including CRT, his bundle pacing, and left bundle pacing. Cybersecurity concerns were also raised, with panelists emphasizing the need for patient awareness and healthcare provider knowledge in addressing potential vulnerabilities. The deluge of data generated by implantable devices was also discussed, with a call for developing algorithms and workflow strategies to effectively manage and interpret this data. The importance of evidence-based medicine and the need for further research and clinical trials in the field were emphasized.
Asset Caption
Topics Include:
How to elect the right platform for the right patient: precision implants
Heart failure and EP docs: collision or collaboration?
Hype or hope - alternatives to classic CRT
When to change the tried and true ICD nominal programming
Device monitoring and cybersecurity
Responding to another device advisory
Keywords
cardiac resynchronization therapy
his bundle pacing
left bundle pacing
implantable cardiac devices
cybersecurity concerns
data management
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