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EP on EP Episode 88: Sudden Cardiac Death Trials - ...
EP on EP Episode 88: Sudden Cardiac Death Trials - ...
EP on EP Episode 88: Sudden Cardiac Death Trials - Past and Future with Jeanne E. Poole, MD, FHRS
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Video Transcription
Hi, I'm Eric Prystowski and welcome to another episode of EP on EP. It's an absolute delight to have my guest today, Dr. Jeannie Poole, who is a professor of medicine at the University of Washington in Seattle. Welcome to the show, Jeannie. Thank you. So I was trying to figure what would be the best thing to do with our interview today. And you've been involved in so many types of trials, but you've really had a major interest in sudden cardiac death. And rather than review all the trials you've been involved in, from your perspective now, let's just have a conversation on where do you think we should be headed? I mean, what kind of trials? I'm sure you've given a lot of thought, so why don't you start? Yeah, absolutely. Yeah, it's a great question. I think we're really at an inflection point with prevention of sudden death. We have all the old trials. Most of us know them very well. They're critical. They still inform the guidelines. And the guidelines haven't really changed much. We have Danish. Danish was a disruptive trial, but really we need to now take it beyond that. We need to take it beyond that because so much has changed. When you think about the fact that 2005 was when ScudHeft was published. That's when the NCD was really determined and guidelines, and not a lot has changed since that time in terms of the indications for devices, but a lot has changed in terms of patients and patient care and what we're looking at in heart failure patients. So if you look at, for instance, the Paradigm heart failure trial in Tresto, and the reduction in sudden cardiac death just due to a good heart failure medication. You now add SGLT2 inhibitors on. You know, we have reductions that are at least about 60% in sudden cardiac death just from heart failure medications. And the reduction in sudden cardiac death by the ICD in both companion, ScudHeft made it was 60%. Now so what we have to do is figure out what's on top of that. So how can we make that be more than that 60%? So we have some risk prediction models. So we can look at the Seattle Proportional Heart Risk Model. We can look at what Christine Albert's doing with her group and, you know, predetermined to try to identify those patients at risk. So this is what's really different from when all of those classical trials were done. So we weren't really, I mean, the event rates were so high back then, right? I mean, people had high event rates, mortality rates, they had high sudden death rates. It's really changed. And we also cannot lump everybody together. That's another real issue that we have to think about as we go forward in trials. We've got ischemics, they're still at high risk. They are a group of patients that are likely to continue to benefit from ICD therapy. But the non-ischemics isn't just one group called non-ischemic cardiomyopathy. It's this whole, you know, heterogeneous population, all of them with different sudden cardiac death risks. So how are we going to design trials for that? So let's, let me pick this apart now and have you just respond to it. So let's start with the newer agents. I've heard a lot of people opine that guideline therapy now should include things like, you know, Entresto, SGLT2 inhibitors. That's fine, except there are no data, right, to say you have to do that. And I'm a bit conflicted myself on what to do. I mean, do you think we need another trial? It seems impossible someone's going to do that trial, right? What do you think is the right thing to do now? Well, I mean, the new heart failure, updated heart failure guidelines definitely support using those medications. So I mean, it's an important question because now if we are going to expect those patients to be on all of those medications, we better have some, you know, good, further trials. We need more trials to support this update to the heart failure guidelines. I'm concerned about, you know, how do we go forward designing the next, you know, Danish or the next whatever, SCUDHealth, you know, two trial in the setting of all of these medications. Do you demand that all patients be on, you know, quadruple heart failure therapy? Is that what's going to be optimal medical therapy? What about HEPPF? You know, what do we do with those patients where there's even less medical therapy? So this is what I mean. I think we're really at this inflection point where everything's changing so fast. Heart failure medications are changing. Our understanding of heart failure is changing. And where do we do, where do we put ICDs in the middle of that? All right, so let me even be more controversial. Okay, great. It's not that I'm ever controversial, mind you. No, never. I am convinced that we've been chasing this, the wrong guy, this EF. And you know, and everybody kind of gives lip service to that. It's not the only thing. But the data on fibrosis are very strong in multiple disease states. So personally, I'm more worried about a person with an EF of 45% that has scar than 30% with no scar. So should we be doing those trials? Well, we're doing it. I mean, I'm not doing it, but you know, the CMR guide trial is, you know, a randomized trial that's looking at, you know, LG and the randomizing patients who currently don't fit the clinical guidelines to an implantable loop recorder versus a device. So I mean, we've got some of these trials going on. I think that the real issue is does scar predict all-cause mortality versus does it predict ventricular arrhythmias at proportional levels that we can figure out who needs the ICD? We know from individual trials, the scars associated with ventricular arrhythmias. We already know that. But we still have to find that patient population within all of that that have a relatively low all-cause mortality and a really high risk of sudden cardiac arrest. Maybe, you know, LGE will tell us that, but it's not going to be presence of yes or no. It's going to be the pattern of the LGE, how many places, you know, the myocardium are affected and hopefully out of that, we can take LG and put that together with known clinical risk factors to start identifying appropriate patient groups. But like I said, being controversial, for me, when I'm seeing a patient sent to me who meets non-ischemic, you know, criteria for an ICD because of EF, even though they've had guideline therapy, if they have no scar, that's part of my discussion now. I don't say no, but I tell them I think they're at low risk because there are plenty of data to support that. So I guess my point is, does it matter if you're on Entresto, okay? I don't know if that's the key. If that's going to make your EF better and your heart failure better, that doesn't necessarily mean you risk a sudden death in that particular patient that has scar. We don't know, right? We don't know. That's the problem. Right. The other problem, well, there's two points. I mean, one, if it's a sarcoid patient, we now do have support to implant an ICD despite LVEF. So that's an example of a disease process based upon utilization of scar. Right. Right? I mean, that's what that is. Whether or not we have a, you know, example disease and whether or not we can roll that out to other forms of non ischemic cardiomyopathy, I don't know. I hope so. I mean, I agree with you. A lot of scar really worries me. But what do you do if you've got a patient with, you know, 45% left ventricular ejection fraction and a scar? How are you going to then go about putting an ICD in them and get it paid for? You can take them to the lab. Right. Right? You can go to the lab. Try to start something. And go old school, but not just old school. It's new school. The Australians are doing that. Right. They've resurrected doing EP studies. Yes. So you can do that. You can do that. Right. But how was he... Oh, I agree. How was he going to get that paid for? There's a difference of what my current thinking is versus reality of what I could do, Jeannie. No, I'm just saying in the discussion of trials in the future, I think that's key. And I think I'd rather chase the scar than the EF is what I'm saying. Oh, me too. Absolutely. I agree. Because both of us have been involved in all those trials where you have so many patients with a low EF and you put an ICD in, nothing ever happens. And if you went back now, I bet most of them had no or minimal scars. I mean, even in the Scud Heft era, over the course of five years, 80% of the patients never used their device. Right. That's the most... So we know that LVEF cutoff is not helpful. We know that New York Heart Association class is even fraught with error because it's subjective. And I don't know what that means today to be able to compare to what it meant in the past. So we have all of these questions that need to be answered. I agree. So many questions. So many questions. So one last thing. So the other thing that really bothers me is mitral valve prolapse. Oh, me too. Okay. So when you have a boutique disease like that, I mean, no, how do we study it from a trial standpoint? I mean, we didn't ever really study Bugatta because it's really hard, right, to study boutique diseases where you don't have huge numbers. But I'm very worried about that subgroup, the arrhythmogenic group. So what are you doing with that patient now? I worry about them. I have nightmares over those patients. Yeah, it's worrisome. I mean, we've been around a while, you and I. And I mean, I can remember those patients way back when being really, really worried about them. You know, we need to have a multicenter, you know, really well-described prospective registries. You can't do a randomized clinical trial. We didn't do randomized clinical trials for accessory pathways, right? I mean, we knew that it worked and we followed people and it got adopted. I think you're right. I think these boutique things are going to be dependent upon prospective registries. A lot of patients are at very high risk, you know, annular disjunction and the patients who are having... And that's even the worst, right? Because we have at least some clues on what to do with the high-risk patient by leaflet myeloid prolapse, the scar, T-wave inversions, but this MAD stuff, you can have it without the prolapse, right? I know. And it's like, I know it's a risk factor, but I have no idea what to do with it. No, I know exactly. I mean, I literally lose sleep over those patients and find any reason to get an ICD in them. Yeah, because really often they have good hearts, right? And it's a tragedy when they pass away. Thank you for your insights. It's always wonderful. It's great to see you. Take care. Thank you.
Video Summary
In this episode of EP on EP, Dr. Jeannie Poole discusses the need for new trials in sudden cardiac death prevention. She highlights the changes in patient care and heart failure medications that have occurred since the old trials and emphasizes the importance of identifying patients at risk. Dr. Poole also debates the role of newer agents, such as Entresto and SGLT2 inhibitors, and the need for further trials to support their use in current guidelines. Furthermore, she discusses the role of scarred myocardium as a predictor of sudden cardiac death and expresses concern about boutique diseases, such as mitral valve prolapse, and the challenges they pose for trial design.
Keywords
sudden cardiac death prevention
patient care
heart failure medications
Entresto
risk identification
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