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EP on EP Episode 71: Pill-in-the-Pocket Anticoagul ...
EP on EP Episode 71
EP on EP Episode 71
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Hi, this is Eric Kostowski, and welcome to another episode of EP on EP. I'm delighted to have a friend and a person doing some really important research in this topic, Dr. Rod Passman, who is the Jules J. Rheingold Professor of Electrophysiology at the Northwestern School of Medicine. Welcome, Rod. Thank you so much for having me, Eric. Well, the topic today is one that is particularly dear to your heart and maybe the hearts of many others, and it's the pill-in-pocket anticoagulation for AFib. Before we let you go on that, let me just give a predicate to those who may or may not know some of the background of the pill-in-pocket concept. It was initially used to treat episodes of AFib with either propafenone or flecainide, and it goes back many years. But Rod, you've taken it into the arena of preventing strokes with AFib. So why don't you tell us a little bit about the concept? So actually, it actually stems from a really personal experience. I was taking care of a patient who 10-plus years ago we had on Coumadin, an antiarrhythmic drug, and he had no subsequent episodes of atrial fibrillation for the years that I followed him. But because of his CHADS-VASc score and because our guidelines say that we don't make decisions about anticoagulation based on whether or not we've achieved sinus rhythm, I kept him on his anticoagulant. That is, until he came in with his intracranial hemorrhage. And I see him now years later. He is wheelchair-bound, severely dysarthric. This changed his life and the life of his entire family. He never worked as a lawyer again. And I asked myself, why did I continue him on his anticoagulation? And at that time, we had no way of rapidly anticoagulating someone with an oral medication like we do today. We had no way of rapidly assessing whether someone slipped back into AFib because unless they had a pacemaker or defibrillator in, and even then it wasn't so easy. And we didn't really know how long of an episode of AFib we should be worried about. Obviously, we have some clarity on some of those issues. We now have NOACs that will rapidly anticoagulate you. We now have implantable loop recorders and we have wearable devices that can sense AFib remotely. And we now have greater granularity that it's hours and hours of AFib that increase your stroke risk, not minutes. So really, that was the origin of the concept. So I know you've published on this already. Give the audience a little bit on your preliminary study, because I know you're planning a larger study. And also, what kind of patients, like what CHADS VASc scores would you put into this kind of a concept? So the first study that we did was with implantable cardiac monitors. It was called react.com. And actually, you played a role in this, Eric, because this was a pilot study funded by the NIH and maybe 60 patients with a CHADS2 score, I think, sort of around two. And we used these devices to do exactly this, pill-in-pocket anticoagulation. And I say you played a role because when we found the results, we showed a 95% reduction in the time on anticoagulation compared to historical controls. Interestingly, we had two major bleeds, both occurring off NOACs, both traumatic, both what would have likely been life-ending. But your role was that you were the editor of JCEE and you took this paper after it had been rejected because it was viewed as sort of a heretical fight from other reviewers. And you said, I like controversy. So I'm grateful for you taking that risk. We did a subsequent study called Tactic AF with Peter Zimmerbaum's group in Boston. Again, now with dual chamber pacemakers and defibrillators. And here too, we showed a 75% reduction in the time on anticoagulation. In both studies, there was zero strokes. Of course, not everyone needs a transvenous device and the use of implantable monitors for this indication is really not feasible and it's cost prohibitive. But now we have wearable devices, right? Like Apple watches and whatnot that can passively sense atrial fibrillation and confirm it with an ECG. So the next phase will be to use wearable digital technology to sort of guide this pill-in-pocket approach. So next stage is going to be much bigger. Now you mentioned the wearable. So there's two ways that I was going to ask you that one could do this. You could do it with an implantable loop recorder and you can have a wearable. Give you a personal experience that I've told you about before. A patient recently came in and they showed me their, it happened to be an Apple watch and they said, you know, they weren't sure what this was and they showed it to me and didn't call it AFib. And it was AFib for sure when I looked at it, but it was fairly slow, like maybe not grossly irregular. So one of my concerns that I would ask you is this would have to be fairly sensitive, whatever you do, right, to pick it up. Are we there yet is my question. Yeah. Well, I think, you know, the devices that we have now, remember, for example, the Apple watch is FDA cleared for patients with no known history of atrial fibrillation. It's sort of cleared to screen for atrial fibrillation. And it does that in two ways, right? It uses PPG to intermittently check your pulse. And if your pulse is irregular for an hour or more, it will then give you alert that you have an irregular rhythm and you could either check your ECG in response to that prompt or whenever you want, but it won't call atrial fibrillation if your heart rate is too slow or too fast, or, you know, if you have flutter, for example, at a rate of 75, it may miss that. So, you know, I think that we're just beginning to see this technology being used. And I think there will be great leaps in how we use this technology and the applications of artificial intelligence to make devices that are better suited towards sort of what I want to use it for. And really I'm more suited as leaning more towards sensitivity and less towards specificity, which you would want if you're dealing with a population known to have atrial fibrillation like we're doing. So we're just seeing the beginning and listen, you know, Apple Watch didn't exist, didn't have ECG three years ago. Think of how far we've come and see how many patients come to you and me, you know, self-diagnosing with arrhythmia is that we otherwise wouldn't have caught. So we've come a long way and we have a long way to go. Let me talk a little bit about some of the controversies in the field, regardless of whether you're going to do pill-in-the-pocket, just even anticoagulating. Nobody really has a good handle on duration and when you need to, right? So we know that, I think most of us would agree if somebody is a high-chance BASC score, you know, four or something like that, and they're known to have AFib, I mean, at least for me, I would feel more comfortable if they're on anticoagulation all the time. But, you know, these patients that you've been looking at, are you really worried if someone has a one-minute episode? I mean, my guess is I'm being silly a little bit. The answer is going to be no, but so where do you draw the line? Because you're going to have somebody in your concept of pill-in-the-pocket start an anticoagulant for a minute of AFib? Well, I think, you know, you raise a great question, you know, from all the work that we've done and what others have done, you know, I think that there's not one threshold of duration that suits all people. I think that the more risk factors you have, the less AFib you need to contribute to that stroke. You know, we're focused in on a CHAZ-VASc one to four population with no prior stroke and no heart failure, right? Because they can't have an indication for a defibrillator, for example, because if you're paced during your AFib, the RR intervals will be regular and the watch won't pick it up. So essentially, you know, we're dealing with that, I don't know, 66-year-old female with hypertension that you've done an ablation on, and every monitor that you do shows no AFib. You know, are you going to put that person or leave that person on anticoagulation for the next 20 years of their lives? You know, I think that the decision is easier if it's not all or none, right? Not saying I'm blindly going to continue it indefinitely or I'm blindly going to stop it indefinitely. What I'm saying is we're going to give it to you only for a short period of time, you know, after a prolonged episode, and we could get back to what that is, and therefore sort of maximize the benefit while minimizing the risk. Now, I think that the duration that we're interested in is measured in hours. For the pilot study that we did and for the clinical trial, we're saying if your watch says an hour or more of AFib to take your blood thinner for a month. Is that too little? Maybe, but we want to also include the scenario where someone doesn't sleep with their watch, develops AFib at midnight, puts in their watch at 7 a.m., and at 8 a.m. have been told, yeah, you've been in AFib for an hour. So I think we may be, our threshold may be too low, but since we don't know the answer to that, we'd rather err on the side of caution, and again, even using that one-hour threshold in the pilot study, we saw this, you know, 95% reduction in time on anticoagulation. If we raise that threshold to a higher number, we would even see a greater reduction. I think you're being uber careful by doing four weeks. Well, I think you're right. I think we're overkilling, but we also have to account for that person who goes into AFib, is in it for a week, start their anticoagulation immediately, and then gets cardioverted. You know, are we going to tell that person a week to 10 days? No, we want to be consistent, and again, if we're wrong, I want to be wrong because the concept is wrong, not because we try to sort of be clever and ask too many questions at once. So then let's get also back to the point, then, if somebody's having an episode a month, then obviously this process isn't going to work, right, because- Correct. Starting is stopping. In your initial study, what was the frequency of the episodes in your study? Well, Eric, I got to tell you, when we first started doing this, you know, members of the AP community said, you'll never be able to do this because these patients are going to have more AFib than you realize, and you're never going to be able to consistently stop it. And actually, what we found was that of our, you know, 60 patients, only a third of them had any episodes of AFib lasting more than an hour over a 14-month period, and those that did averaged two episodes in that 14-month period. So, you know, we're screening these patients beforehand, right, with some sort of monitoring to make sure that they are low-burden patients. But, you know, I think that there's- we can select for a group that are low CHADS-VASc, low AF burden, and yet, by today's standards, are still treated with a lifetime of anticoagulation in the same way that a CHADS-VASc six-patient and chronic atrial fibrillation receives the same sort of effective but dangerous therapy. And that doesn't make a lot of sense to me. Yeah, I got it. We don't have much time left. Do you want to just give the audience a very brief overview of what the trial- your next trial is going to be, like who's in it, and that sort of stuff? Right. So, actually, this study is called REACT-AF. We have been negotiating with NIH to get this through. It's a trial of about 5,500 patients randomized to either continuous NOAC or DOAC therapy versus watch-guided pill-in-pocket anticoagulation. We're taking patients with a CHADS-VASc score of one to four, and the minimum follow-up time is three years. So, I will be reaching out to maybe many people to look for sites, and I think that this is really an exciting trial that perhaps can change the way we manage this common problem. Well, I think it's great what you're doing, and I'll raise my hand. Count me in. But, of course, you knew that. We've talked about it before. I think this is an exciting area. We don't have all the trial data in, but based on your original observations, I must say I've succumbed to using this. When I say succumb, what I mean is I'll tell someone I want them on it, they're not going to go on it, and we do this compromise that I succumb to their willingness to at least carry the DOAC with them and use it. So, I think your trial will have very important implications for the field, and I congratulate you on pursuing this goal, Rod. Well, listen, if I can make Eric Krznowski a convert, my day is made. Well, I appreciate that. Listen, thank you so much for being part of the show and for educating us on this really new and interesting concept. Thanks, Rod. Thank you. Bye-bye.
Video Summary
In this episode of EP on EP, Dr. Rod Passman discusses the concept of "pill-in-pocket" anticoagulation for atrial fibrillation (AFib). The idea originated from a personal experience with a patient who suffered a severe intracranial hemorrhage while on anticoagulation. The goal of this approach is to rapidly anticoagulate patients during AFib episodes to prevent strokes. Dr. Passman conducted pilot studies using implantable cardiac monitors and dual chamber pacemakers, which showed a significant reduction in anticoagulation time without any strokes. The next phase of research will involve using wearable devices, like Apple Watches, to guide the pill-in-pocket approach.
Keywords
EP on EP
Dr. Rod Passman
pill-in-pocket anticoagulation
atrial fibrillation
wearable devices
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