Hi, this is Eric Prystowski. Welcome to another segment of EP on EP. And this is a very important segment. I'm lucky today to have with us Dr. Rachel Lampert, who's a professor of medicine at Yale University. Welcome to the show, Rachel. I'm so glad to be here, Eric. Thanks. So this is really important clinically, and you've spent years studying this problem of the use of the ICDs in an athlete and who can play sports. So why don't we start back a little bit of why there was a problem. What did the old guidelines say if you had somebody who had an ICD? Well, so there was the Bethesda Guidelines in 1995, and actually prior versions as well, which were written as sort of yes, no, black, white, you're in, you're out sort of documents. And what that document said was that if you had an ICD, you were restricted to sports which were less intense than the 1A. So some examples of 1A, low static, low dynamic. We've got golf, we've got billiards, you probably didn't even know billiards was a sport. I played billiards when I was a kid, and it was a money sport. I didn't know it was considered a sport. So that basically up until recently, that was what the guidelines said, no sports more vigorous than golf or bowling. So you then took on a really important task. So you and your colleagues decided that you had to study this problem. I know you've done this for years. Can you try to summarize for us kind of the main points of the research you had done in this area? Well, so we started with a survey, and that was sent out by myself, colleagues Brian Olshansky and David Canham to members of what was then NASPI, obviously now HRS, where we just asked electrophysiologists, do you have patients with ICDs who are participating in sports? And if so, how are they doing? And we had a fairly good response. And what people were telling us was that almost everyone had at least one athlete doing some kind of sports, contact sports, competitive sports, and we didn't hear a lot of adverse events being reported, or really no adverse events were reported on that survey. So what that survey told us was that there were athletes out there doing their sports with their ICDs. And so we know that results of a survey are biased, recall bias, who chooses to answer. But it told us that with these patients out there doing sports with their ICDs, we could do a prospective study. It would be feasible because there's athletes out there doing it, and it would be ethical because we wouldn't be asking people to do anything that they weren't already doing that was against the guidelines, but rather we were just going to follow them, them having already made the choices that they had made. Oh, I'm sorry. Go ahead. That's what I was just going to say. So we ended up, we then launched the prospective ICD Sports Registry. We enrolled 440 athletes, 77 were like varsity, JV, high school, college, and the others were young adults or kids doing less intense sports. But they all were competitive. And we followed them for four years. Okay. And what were the major observations? Yeah. So the main findings, the main questions that we posed in this study were, would these athletes be experiencing cardiac arrest due to either failure of the ICD to resuscitate the patients or failure of the ICD to convert the patients, or injury due to either syncopal arrhythmia or just getting a shock? And what we found was zero, zero occurrences of those two primary endpoints. That's phenomenal. Yeah. And now I think I've asked you this in the past, but maybe a secondary analysis, one of the concerns had always been out there that maybe you could damage the lead or the ICD itself. Was that, did that come out in any other analysis? Well, so we did look at lead malfunctions and we didn't have a control group because all of our patients were athletes, but what we found was rates of lead malfunction that were very similar to what's in the published literature at five and 10 years. So no additional harm. So it really didn't look like there was a lot of system damage. So I'm guessing there were probably therapies given though, but nobody got injured. So can you tell us a little bit about that? Correct. Yeah. So patients did receive shocks. So they received appropriate shocks, they received inappropriate shocks, and they did receive both appropriate and inappropriate shocks even during competition. But they also received both inappropriate and appropriate and inappropriate shocks either during other physical activity, just raking the leaves or at rest. And in fact, what we found was that there were, while there were more individuals who had appropriate shocks during some kind of physical activity, there was actually not more events during competition than there were just mowing the lawn. So let me ask you this, based on what you found in your research, did you then suggest other therapies? In other words, did you suggest the higher use of beta blockers or something or did none of that actually fall out? Well, we didn't, because it was not randomized, we did look at beta blockers. It didn't look like beta blockers were making a difference. What was making a big difference, so not surprisingly, was programming. And so we know just from studies in unselected populations that you're going to see a lot fewer inappropriate shocks with higher rates and longer detection durations. And we certainly found that to be the case here as well. We found that using made-at-RIT-type programming decreased the number of particularly inappropriate shocks, both during competition and in general. So we've come from, like, you shouldn't participate at all to, I'm guessing, a change in the guidelines, right? Yes. So tell us about that. It was really, it was nice to see that based on these data, that the most recent guidelines, which are now called the AHA-ACC Eligibility Guidelines or Recommendations, which came out in 2015, now describe competitive sports for a patient with an ICD as a class 2B or something that may be considered. Okay, so now we come to the big question, right? And I think the field owes you an enormous amount to get us to this point. Because for me, if you're an adult, I've never, and I've been up against this many times in my career, having to tell some athlete that you're benched or not benched or explain it to a school. I've never felt comfortable with that. I don't think that's a fair decision. So are we into the, how do you now feel we should approach this with the shared decision-making type of thing? Yes, absolutely. I think the formatting of the new recommendations is a big change. The 2015 now uses the ACC class of recommendation level of evidence, which really acknowledges the fact that we don't have all the answers, as opposed to the older document was like, you're in, you're out. And so absolutely, shared decision-making is the way to go. So when you have a patient in front of you, can I play sports, can I not, it's not a yes or no answer. You talk to them about what are the data, you talk about do you, the patient in front of you, fit into the data, how close are they to the patients in your study, what are the limitations of the data, what are the potential risks, even if we didn't, why do the guidelines writers write what they do? And so it's really not, I don't see it as me saying, you can, you can't, so much as these are the data that apply to you, these are the risks, these are the benefits, let's think it through together and think about what you want to do. I think it's wonderful. So I'm going to give you two quick scenarios because we don't have a ton of time left. So the first one I think you can answer for sure, because I'm sure you had folks like this in your database. So I have a high school kind of star soccer player, wants to go to college and play and has an ICD, and I have to write a letter for the school after you sit down and do the shared decision-making. Okay to recommend it as long as the patient understands risks and benefits? Yeah, so this patient would definitely be very similar to the type of patient that was in our study. So we have to talk about what the underlying disease was, and that's an important aspect of the decision as well. But we have a lot of soccer players. Yeah, I'm just going to interrupt you for a second. So we're not going to recommend sports for someone who shouldn't play sports, right? Right. So there's other considerations in addition to the ICD. So for example, as we know with ARVC, there's increasing data that it can worsen the phenotype. But taking that, just thinking about other types of patients, that's obviously a big part of the discussion is what's the underlying disease. So they have to be able to, in your judgment, participate in a sport. Right. So for the soccer player, let's say Long QT, HCM, they fit the phenotype of who was in our study. We're able to say, so the first thing I would say is based on our study, I can say your risks are low. We can't say the risk is zero. We didn't have 400,000 patients in our study, we had 400, but I think we can say that the risks are low and talk about what are the potential risks, but again, that they're low. When I write my letter, I don't use the word safe and I don't use the word clear. I think the concept of clearance is kind of a bizarre concept in general, but the way my letter to that school is going to say is that I think the risks are low, so-and-so in front of me understands what the risks are and that they're low, and I think it's very reasonable to allow him to make the decision to play. So with my last question, what if they want to play football, enough data or is that yet to be determined? Well, so in our patient population, we did have a lot of soccer players, basketball players. We didn't have a lot of really violent contact sports, so we didn't have ice hockey, we didn't have varsity football. So what I would say to that patient is that I think the safety data that we have on conversion of an arrhythmia probably is no different between football and soccer. Whether the risk of damage to the system is different, that we have to say we don't know. Probably more risk of damage to the head. Well, yes. Absolutely. Yes, absolutely. Absolutely. And I think that's often, that's a long conversation. Yeah, not for this show. Right. But I think in general, the concept that thinking about risk in general. So everyone who plays football takes a small risk, you know, and people are comfortable with living in that way that, you know, life has some risks and so I'm going to take them. And I think that it's a similar type of decision. Well, this has been a remarkable update of years of data that you've provided for the field and an extremely important piece of data. And the field owes you and your colleagues a thank you and I'm delighted you're with us today. Thanks. Well, thank you very much, Eric. It's a pleasure to be here. Okay.

implantable cardioverter-defibrillators

ICDs

athletes

sports participation

guidelines