Thank you, thank you David and Rod for giving me a very specific topic. So what I did with this is, and I can't obviously cover all of the challenges and all of the future of electrophysiology, but I tried to pick areas where looking on the agenda maybe some of that information wasn't covered and just some areas that were I thought interesting. Okay, so just in general, lots of challenges and opportunities, but let me just start out by listing just a few of them that came to mind. Well, we want to provide high-quality patient-centered care, and you've heard here too, we're going to talk to the patient, get them involved and try to, you know, let them get involved with their therapeutic options and what they're going to choose. We want to be efficient. We know we're a team, and so we're not just the physician. When we're in the lab, there's a lot of people that are taking care of this patient. We want to train the necessary workforce to care for patients with heart rhythm disorders and, you know, it seems like, you know, maybe it's time that we need more of a workforce in lots of different areas, not just physicians. We want to provide access to educational tools for us to be able to stay up-to-date and to be able to deal with problems acutely, and we want to develop research initiatives to promote participation in studies as we're all much busier clinically. We want to enhance diversity of the healthcare workforce and of the patients that are studied in clinical investigations. We want to assure that we can get, we didn't talk about really reimbursement, you know, but reimbursed for these things that we're probably often not getting reimbursed for, but we want to make sure that we can support the appropriate infrastructure to take care of things like that, rhythm strips, you know, transmitted from a watch. And then really, you know, part of, and a key part of this is collaborating with everyone here in the room, our industry partners to want to continue to enhance innovation. So, I'm going to talk, you know, mostly about some of the innovation that we have and then the role of HRS in my current role as president, which has come to, you know, light over the past few years. We'll talk a little bit about devices and thinking that you probably had less about devices in the past two days and then talk more about education, training, and research. Lots of different types of devices, you know, let's start out with talking a little bit about leadless pacers. Okay, so why do we, so why do we, why are we thinking leadless? What are our unmet needs? Well, we have complications related to transvenous leads, you know, pneumothorax, venous access certainly could be an issue here that we used to have a lot of leads placed in, now we extract them fortunately much earlier. Lead reliability down the line, lead fractures and insulation problems, and then pocket issues including pretty severe infection in that case, and this is an example of a lead fracture usually underneath the clavicle is the most common area. What are the kinds of devices that we have? Only one right now that's approved by the FDA, but other companies are investigating leadless systems. One of the investigations that's gone on for a while now is this system where there's a receiver or a left ventricular endocardial electrode that converts acoustic energy to electrical energy, and this is done by placing a separate transmitter underneath subcutaneously in this area, and you have another separately implanted pacemaker, lots of pieces to this system where it senses the RV pacing electrode and triggers left ventricular stimulation, so you can get resynchronization therapy in this manner. Does it work? Well, we can implant, you know, these things can be implanted, you can get effective biventricular pacing with it, you can improve heart failure class, but it still hasn't really made it out there yet because there's significant complications related to this, and that's still, you know, being, you know, developed and looked into further. What we do have is one of the leadless pacemakers is available. This is for right ventricular pacing. There's timed electrodes on this one. This is the Medtronic device. This one's not currently approved in the United States by the FDA, but that has active fixation electrodes there. They both have rate-responsive pacing and, you know, are implanted through the venous system through the femoral vein. They both effectively implanted in a very high, over 95 percent of cases, and it seems like thresholds seem to be stable down the line and the signal amplitude seems stable down the line, but there still are challenges, so still not everyone's doing them. There are a minority of pacemakers. There's still risk to trauma to the vascular system with these large sheets needed to pass through the groin as well as in the heart. You still have a lead in the heart that can perforate. There's now, up until just real recently, we just have now available atrial sensing ventricular pacing, so VDD pacing, so it's just a single pacemaker self-contained device that sits in the right ventricle, but it can sense some atrial activity so you can get more synchronous pacing, and so we'll see how that works down the line, but still at the end of life, so we think it would be nice to implant these in young, healthy patients so they don't have wear and tear on the transvenous systems, and the younger patients are more active and more likely to get lead fractures and insulation problems, but the problem there is, you know, they're young and they're going to need a lot of devices throughout their lifetime, and these things tend to really endothelialize, and you can get a lot of tissue ingrowth, so to extract them, you know, can be an issue, and so what do you do with all these little pieces of, you know, these devices that are sitting in the right ventricle? So this is the one, this was just recently published actually, looking at just 75 patients with this new algorithm that can sense, and it seems to be pretty effective, would be able to sense to be able to get VDD pacing, so we'll hear more about this as time goes on. The other way to do it is you have a leadless pacemaker that sits in the right ventricles, self-contained here, perhaps you could put another one in the atrium, and then, but they need to communicate to get synchrony between the atrium and the ventricle, and that needs to be a wireless communication which needs to have its own challenges. Theoretically, I guess you could put another one in the LV if you wanted to get BiV pacing. So what else is new in pacing? Pacing was actually boring for a long time, so now we have new things going on, so now you hear a lot about, I don't know if you heard much about, or yesterday at all, I wasn't here, but HISS bundle pacing is another new way to pace and to get a more normal activation sequence instead of pacing out here, you go through the normal intrinsic conduction system, or you could do left bundle or transeptal pacing as opposed to right ventricular pacing. Other ways are that you might be able to use this in other patients who didn't respond perhaps to resynchronization therapy, or in patients who are not currently indicated for CRT, those who don't respond as well to the non-left bundle or just have a normal QRS, is it better or not to put a lead down here or to put one closer to the intrinsic conduction system? Those are questions we're going to need to answer, but we do know that chronic right ventricular apical pacing can result in heart failure, and this is an older study showing that if you're pacing over 40% of the time, you're more likely to have heart failure hospitalization than if you're pacing infrequently because you get dyssynchrony in the left ventricle with pacing at the right ventricular apex. The concept of his bundle pacing or selective his bundle pacing is to normalize your QRS complex where you have a right bundle here, and if you're pacing, you can overcome that right bundle and get a narrow QRS complex, and this is what the lead positioning may look like. We don't really have large randomized studies in this area at all yet. This is the best we probably have in looking at patients who in one center, several centers in the country that have done, and outside the country that have done a lot of this. One of these centers has a Geisinger, had one hospital they were putting in his bundle pacing only, and the other one they were doing RV pacing at a sister hospital, and they compared the outcome. This is just observational, not randomized, so to take it with a grain of salt still, is that you can implant these devices in most patients in 92%, and this is a very technically expertise center here. They've done a lot of these devices, but showing overall the primary outcome of death, heart failure, hospitalization, or needing a Bi-V device was lower in those who had his bundle pacing than those who had right ventricular pacing. Again, more to come. We know that over time, there's been lots of papers written, still not a randomized study though. Looking at 26 papers, yes, we can implant it in 85% of the cases. We're successful with implanting them, and over time, the capture thresholds are higher than with transvenous leads, but most patients stay pretty stable over time. You may wear out the battery a little sooner with the higher output pacing, but occasionally, individual patients may have a higher threshold, may go up over time, and you may need to revise the system. So, we do have a very limited number of experience sites. We still have, compared to transvenous pacing, very short follow-up. We may have high thresholds compared to transvenous systems, and then the question arises, if patients are pacer-dependent, and if you have a problem with the output or dislodges early on, you don't have much of an escape rhythm, do you put a separate RV backup apical pacer in on top of that? What if you develop further conduction system down the line? These are all unanswered questions, again, calling for industry, in particular, to help us do some randomized trials in this area. So, more to come there. Another hot item now is left ventricular septal pacing, screwing in a pacemaker lead to the septum and pacing the left side, because the normal conduction system, you'll activate the left side of your septum before you activate the right, so it's more kind of a normal, intrinsic way to do it, and this is looking promising. This is just one study early on, looking at an improved hemodynamic effect from it, but more to learn here. Lots of new exciting things. So switching over to implantable defibrillators next, well, we know that the leads, the transvenous lead in an ICD is the weakest link or the most fragile component of the system, and this just shows you a compilation of lead survival over time. You can see as time goes on, transvenous lead failure increases. Some of it has to do with specific leads, maybe more prone to failure than others, but just being in there longer, particularly some patient characteristics, young, healthy, active patients more likely to have lead problems. So because of that, the initial impetus for putting in a totally subcutaneous ICD system was that nothing is in the heart. You don't get that wear and tear of the lead in the beating heart, and the lead, you know, may not wear out over time, and your shock is delivered between the can and the coil here. There was the second generation we have now, but the initial generation was by a company called Cameron Health, a startup company. The device delivers 80 joules. Device longevity may be a little shorter. The devices are bigger, but it is thinner, and it is implanted in an area that is, you know, has more fat tissue there, or you can implant it submuscular if you want. Programming is simple, and I think we talked about earlier, we didn't get to comment, I think, on the programming in terms of, you know, you make it simple. It's not that the device is simple. The device has smartness in it, but it's less chance for operator error, right? We think, and I think especially electrophysiologists, we like all the bells and whistles of being able to program different things, but sometimes, and studies have been shown that empiric programming may be better in some cases, too, but the programming options here are just on-off. The device does not have anti-tachycardia pacing as one of the big issues, so no routine bradycardia pacing, so if they need a pacer, this is not the device for them right now. It does have a little bit of post-shock pacing, but it would be painful because it's, you know, transcutaneous or subcutaneous. Overall, this is a registry as well as the initial approval study in the United States shows that it's a, you know, reasonable, you know, relatively low complication rate overall for systems of ICD types and no electrode failures and no endocarditis, so even if you get an infection, it doesn't tend to get in your bloodstream, so that's a good, you know, feature potentially. Lots of different advantages, disadvantages, but again, just highlighting the lack of pacing capability with these systems right now. You know, you can't get cardiac resynchronization therapy, no anti-tachycardia pacing, and no routine bradycardia pacing. But to come, and this, again, looking at the future, is combining a leadless pacemaker with a subcutaneous ICD. And this is in development. I think it should be, from what I was told, is not too far away from clinical trials where they subcutaneous ICD. So if you need, say you need antitechicardia pacing or you need a bradycardia pacer, you could implant this in after the fact so that the device here can communicate unidirectionally to this pacemaker so you can deliver ATP and give painless therapy. You can envision, later on, even having a left-hand trigger system in place to communicate, but again, not currently available. This I haven't seen anything with, but the new technology, I haven't seen anything more on this recently, but this was presented at the Heart Rhythm Society meeting in 2017, the first, it's called a String. It's kind of thick, it's not quite a String, but it's a whole self-contained device. This is the whole defibrillator system implanted in 22 patients, had a good, reasonable defibrillation energy requirement, but this might be another option for a system. I guess we'll hear more. Now, the one thing I do want to bring out, and this is just a little thing of mine, my interest of mine, is that we need to make sure when we're doing all these clinical trials that we implant devices in patients who are receiving them and that we enroll patients in clinical trials who are well-represented in the overall population and that we include men and women, women as well, and we tend to have a paucity of women who are underrepresented in clinical trials, and this is just one example. We went back and looked at the ICD registry, and you can see that women, actually, this is just a registry, not a research study, of what we're implanting. Women have a higher complication from transvenous ICDs than men, and that's pretty significant. This is out to 90 days. So we need to make sure when we have studies that are designed to include the appropriate population. And then in ablation, I'm not gonna talk much about because you all have heard a lot about ablation over the past day or so, but we have two main ways right now. We've been using radiofrequency ablation and cryoablation. There was a side-to-side comparison in the FIRE and ICE trial where cryoablation was non-inferior with respect to arrhythmia occurrence and need for repeat ablation. So part of it's patient selection. Potentially, you might choose one procedure versus another, but they're both good ways to ablate. This is something that, and actually, Dr. Haynes is very much involved in, too, but pulse electrical field ablation. What we have right now is there's always this, you wanna have lesions that last a long period of time, but you don't wanna get a lot of collateral damage. And this certainly seems exciting and promising with new technology to see if you can get something that's more specific to the cardiac cells and get more tissue selectivity with giving a short duration and high-energy ablation. And again, I'm gonna bring up with ablation as well just to highlight the point to industry. Whatever studies you're doing, make sure you include enough women because some of these are pretty horrendous, actually. Some of these studies showing very small percentage of women enrolled. Cabana, this is Cabana. Fortunately, we're looking at some more details related to that. 37%, at least, were women, and they seem to have a very similar type of effect as men. Ablation did seem to have beneficial effect when compared to drug therapy in women as well as men. Although women are different in other ways, they may have a higher recurrence rate. And whether this is related to, they have more scarring at baseline, whether it's related to getting to these patients at a later stage or not, we don't know. But they also have different, they may have more non-pulmonary vein triggers. So women are different than men. And they may be less likely to undergo a repeat ablation. We don't know why, if they're just deciding that, or what reason. But there may be a difference in outcome in several different studies. Dr. Maroche has done a lot of work looking at fibrosis in the atrium. And if we could better predict how to ablate or who might best respond to ablation, this might be another way to do it. And I did throw in also, women, at the time they get to ablation, do have more fibrosis than men. Whether that's something intrinsic to being female or just that they're gotten there at a later stage, we're not really sure. And I know this isn't really technology, but I bring it up because there's so much more we have to learn to better predict arrhythmias and predict thromboembolic events. There's other things we could use, and there's a whole other field of research going on looking at biomarkers. And we don't really have anything yet, but things like C-reactive protein and D-dimer and BNP, can some of these predict those patients at higher risk of thromboembolic events? Again, we don't know, more needs to be learned. And then we have, we're talking about earlier, predicting arrhythmias. We're talking about artificial intelligence. There's just a huge amount of data out there. And this is just one study I was involved in. We're looking at one of the companies, this was a pocket ECG. This company collects, you can get 30 days of data. It's like a halter monitor, although it's mobile telemetry, but it's a beat to beat analysis. This was over 26,000 individuals that show that if you get this micro AF, I think we as electrophysiologists would typically call this non-sustained atrial tachycardia, less than 30 seconds. What we see in the lab too, it looks more like you get this focus, pulmonary vein focus. You get this APDs, and then you induce AFib. Often you get these warning arrhythmias. And if we can better identify patients who are more likely to develop AFib, this will be key. So in this particular case, if you had this micro AF for less than 30 seconds, between five beats and 29 seconds of AFib, the chance of having true AFib, 30 seconds or more, many were many, much longer than that, was very high within the next 72 hours if you're monitoring that long. So you could think of how this might be relevant to other populations of patients. We have cryptogenic stroke patients, patients who have stroke of unknown reason. Wouldn't it be great if we can predict which patients are very likely to have had AFib causing that stroke? And this is another real cool area, I think, too, is some of these arrhythmias. This has been tracheotachycardia ablation. There's this technology, Bill Stevenson's been very involved in. Sometimes the arrhythmia can arise within the muscle, and we can make deep lesions with the technology that all industry here has given us. But sometimes this little needle can allow us to better deliver energy within the muscle to reduce arrhythmia recurrence in people who have had refractory VT already. And now this is just another really interesting area of non-invasive ablation. So the group at Washington University has created, as well as other places, has done research looking at using X-ray therapy, so like the cancer treatment, and focusing on whether or not we could ablate non-invasively and have the patients just walk out of the office as opposed to having catheters placed in their veins. So this is early on, and being done at very select centers right now, but they did show, and Dr. Kuglik was kind enough to provide this information, was able, you can see that these patients do have fewer arrhythmia episodes. Some people have none during follow-up. And then wearables, we've been talking a little bit about, but lots of information with wearables out there. Digital health is a very big thing. Most of these companies, all these companies here, 66% were consumer-facing, and you could see that a lot of these are related to the self-management, these tools and trackers, which we love. We love the data, I love the data. We just have to know how to deal with it better as you heard on the panel, with all this data coming out in lots of different ways. There's lots of different ways you can do it from watches, you can do it from patches, you can do it with these handheld devices that are compatible with your smartphone. There's also, I have not used, a blood pressure cuff that actually has some monitoring on it too, as well as these implantable devices, implantable loops, as well as pacemakers and ICDs that give us the information. There's also the watch, the Apple Watch is on the steering committee for this study, but we have this pulse notification, just know that it's not, patients need to know, they think I have this watch, I'll always know if I have AFib, that's not true, because it's really only taking samples at rest, and so it's not like doing a mobile telemetry, but we'll get more information. But I think the most, I don't have to go through the results of the study in any way, but the most amazing thing, and those of you who have tried to enroll patients into clinical trials and been involved in clinical trials on the industry end, is that it could take to get 10 or 15 or 20 patients at your one site, you know, can take a year or more, right? But within eight months, 419,000 participants were enrolled, so it's a whole nother way at looking at clinical research, and I'm sure you heard more about that probably yesterday. And how do you increase the yield? Well, the longer you monitor, and the higher risk patients you monitor, the more likely you are to get yield of your monitoring for AFib, this is. But we have to, we still need information about screening. Who should we screen? What should we do with the information with screening? And then, you know, we're spending a lot of time, and our staff is spending a lot of time with us, how do we get reimbursed for this? We do have, and we've thought it's been very important from the Heart Rhythm Society standpoint, we feel very strongly about digital health. We have a committee, Christina Wurster, who's here, is the executive team in charge of that committee, and has really led this initiative, Dr. Marosh and Dr. Tarakiya are chair and vice chair of that committee. And we just finished a strategic plan for Heart Rhythm Society, looking at, what are we looking at for 2021 to 2024? And, you know, everywhere, in every area, everything we talked about, digital health, more digital, you know, digital first. And you can see that's the middle of this here, that circle overlaps with everything else we wanna do. The other parts of our strategic plan are to elevate knowledge and dissemination of information, education, deliver personalized education, because someone who works in the lab and is an allied professional in the lab is gonna want something different than the physicians want. Or in different countries, people may want different things because their healthcare practice is different there. And really with the role of, we should just really embrace our digital networks to help us expand reach and also to deliver the best education possible. And then, you know, how do we deliver this? Up in the, now it's even worse, right? Meetings are being canceled because of other, you know, unfortunate, you know, situations with health right now. But this is the kind of education we're used to. We're used to having people gathering all the time, but not everyone can go. Not everyone can travel and less and less support for travel. So how do we provide this individualized indication throughout the year? We have some, you know, great things, as Eric Christowski does his EP on the EP. There's all different ways you could do this, you know, electronically. We now have Heart Rhythm 365. You can get it from your cell phone and get education that way. And so our attendance, and I suspect, you know, this is gonna, you know, change over time. We've been fortunate from the Heart Rhythm Society standpoint, still get a lot of people come face-to-face to our meeting, but we need to think of what to do for the future and how to reach members in between those meetings. We have research journals. We've had, you know, our Heart Rhythm Journal, Case Report Journal, that was the newer of the two, but now we have two more journals, research journals, that just came out this year, or just coming out. First issue in April of our Heart Rhythm, it's an online access journal to get reach so people can get this information, you know, around the globe and get it electronically. And it's an open access journal, as well as you can see the importance of digital health. Dr. McManus is the editor of this journal and the first issue will come in the summer of a way to publish all this research that we are doing and need to do more of. We have the Heart Rhythm 365, I mentioned you can get also, you know, our physicians and allied professionals can get, you know, credit for that. We have communities, and these are active communities, many different communities that discuss different topics at in-between meetings, things about remote management or any other topics. We also now have a newly launched patient site where patients can go to get information about heart rhythm care. So, we really, you know, I thank you, it's just, you know, to, we thank you for our industry. Partnerships are very important to the Heart Rhythm Society and very important to all of us practicing as electrophysiologists, and we're, you know, a high-tech field, and so thank you for coming today and look forward to feedback from the meeting. Thank you.

electrophysiology

challenges

patient-centered care

device advancements

ablation techniques

industry collaborations