Welcome, my name is Amber Seiler and I'm a nurse practitioner in the arrhythmia services program coordinator at Cone Health in Greensboro, North Carolina. It's my privilege to be with you today at the Heart Rhythm Imagineer Tech Showcase. I would like to introduce you to Dr. Kenneth Stein. He's a senior vice president and the chief medical officer of Boston Scientific, Dr. Stein. Thanks Amber. And what I want to do is talk to you today about our HeartLogic heart failure diagnostic and specifically review the novel heart failure sensors in the device and give you some of our thoughts about the role of automated predictive monitoring for heart failure, particularly now that we're in a COVID and hopefully at some point a post COVID world. Let me remind you, I'm an employee and shareholder of Boston Scientific and in this presentation, I will talk about some concept devices that are not yet approved and may never be approved by the US Food and Drug Administration. I think everyone's familiar, at least in concept, with our HeartLogic automated heart failure diagnostic. It's a personalized remote monitoring system for predicting heart failure decompensations in patients with severe left ventricular dysfunction who are implanted with our latest generation of ICDs or CRTD devices. And specifically, the way the algorithm works is it takes a sophisticated combination of multiple different physiologic sensors that are all determined through a standard implant ICD or CRTD. In particular, what we use is a combination of heart rate, respiration, transthoracic impedance, patient activity, and then in a feature that's completely unique to our devices, heart sounds, auscultated through the accelerometer on the device to create an index called the HeartLogic index and as validated in our multi-sense clinical trial of over 900 patients. In prospective testing, the index had a sensitivity of 70% for predicting CEC adjudicated heart failure decompensations with an unexplained alert rate well under two per patient per year at 1.47. And I think very importantly, the alert preceded the event by a median of over a month, 34 days, meaning that if there's something reversible leading to the decompensation, there's plenty of time for a clinician to act, respond, and resolve whatever it is that's leading to the decompensation. Why do we think that's important? Again, needless to say to the clinicians, heart failure has an important impact on quality of life and longevity for our patients. Heart failure is interesting in that as a syndrome, it's characterized by periods of stability punctuated by acute decompensations. And not only are the acute decompensations difficult enough for patients and costly enough for the healthcare system, but the problem is that after a decompensation, patients typically do not return back to their pre-decompensation health status, but rather worsen progressively over time following each decompensation. In fact, in our MATED-CRT trial, we found that an initial heart failure hospitalization in patients who had been in New York Heart Association class one or class two when they entered the trial, an initial hospitalization was associated with an eight-fold increase in the risk of mortality and a nine-fold increase in the risk of recurrent heart failure hospitalizations. And so being able to predict and prevent acute heart failure decompensations was an obvious benefit for our patients, as well as an obvious benefit in reducing costs to the healthcare system as a whole. And so HeartLogic was designed to provide that early warning system so that clinicians can identify patients at high risk of acute decompensation and intervene prior to the decompensation. I've already reviewed with you the data from our MultiSense trial. What's nice is now that that data has been replicated in real-world clinical experience. So one example is this study by Professor Cappucci et al. from Italy that was presented at ESC Heart Failure and published in 2019, where in 58 patients, they saw almost the same results as we saw in our larger MultiSense trial, again, very high sensitivity. In fact, in this particular population, 100% sensitivity in predicting heart failure hospitalizations, a very low unexplained alert rate. Again, in fact, in this study, it was less than half an unexplained alert per patient you're monitoring. And again, as with the MultiSense trial, a very long warning time between the alert and the hospitalization, 38 days in this case. One of the things that's important to bear in mind is that HeartLogic is also designed to provide the alert before the onset of symptoms. And so we expect that folks who are using HeartLogic to intervene on patients will be talking to patients when they're pre-symptomatic and changing their medication regimen, changing their diet, changing lifestyle, even before the onset of worsening symptoms of heart failure. What's the philosophy behind developing a predictive analytic like HeartLogic? And I want to turn completely away from clinical medicine for a second. There's really a fantastic book that was written by Tom Friedman. He's a columnist for the New York Times called Thank You for Being Late, an optimist's guide to thriving in the age of accelerations. I think we can all use some optimism in the current state of the world today. And one of the things he talks about in the book is the evolution of industrial maintenance in the 21st century. And he talks about the evolution from condition-based maintenance, your car broke down so you take it to the mechanic to fix it, to preventative maintenance, where you bring the car into the shop every three months, every six months for maintenance, to now what's predictive maintenance, where the car actually monitors itself. And a warning light will go off telling you that now is the time to take it into the shop before something goes wrong. There's a fantastic ad that was on TV about a year ago from IBM Watson that showed a elevator repairman walking into an office building in midtown Manhattan. And he's stopped by a security guard. And the guard says, why are you here? And he says, I'm here to fix the elevator. And the guard said, but the elevator's not broken. And the maintenance man says, well, yeah, but it's about to be. And when you think about this, think about our approach to patients with heart failure. Most of what we do in medicine today is still condition-based maintenance. Patients are on a regimen of medications. And we don't really reevaluate that regimen until they show up in the emergency room with acute decompensated heart failure. And that's condition-based maintenance. Or we see the patient in our office every three months, whether they're doing fine or not. And that's preventive maintenance. And what heart logic and algorithms like it give the opportunity to do is to switch to predictive maintenance. Monitor patients' physiology 24-7 and get a warning that this particular patient is now at high risk. And now is the time to do something before they show up in an emergency room. That I think is particularly important for us as we think now about the world likes during the COVID pandemic and as we move into a post-COVID world. Remote monitoring for several years now has been a class 1 recommendation for routine use in patients with implantable devices. But monitoring a device function is only a small part of what we can offer to patients to help keep them out of hospitals and really to keep them as safe as possible. I love there was a tweet from Jag Singh who said he was going out on a limb and predicted in a post-COVID world that 70% of outpatient care will become virtual and that hospital care will primarily be ICU emergency and procedural. He calls that going out on a limb. I think that's actually a pretty strong and firm limb. And I think he's right that this is a direction that we need to move into. And that COVID, if anything good comes from it, is going to help give the impetus to provide more of our care via telehealth, more of our care virtually. In fact, in some surveys that we did at Boston Scientific, we found that the vast majority of healthcare practitioners who responded either started or if they had already been using telehealth, increased their use of telehealth as a result of COVID. And those who increased their use increased the use of telehealth by approximately 70%. And we do see this persisting even as we get through the worst of the pandemic and move into a post-COVID world. So where do we go with that as we think about the future? Well, what we think this implies is that we need to continue to bring out devices that have impactful, important information that enables automated and proactive responses to patients prior to heart failure decompensations. And so the goal will be to enable algorithms like HeartLogic, not just in our ICDs and CRTDs, but in a broader range of devices, enabling it in our SICD, enabling it in a implantable cardiac monitor that could potentially not just be an arrhythmia monitor for patients, but be both an arrhythmia and a heart failure monitor. But also starting to provide more information directly back to patients through a patient app that would provide understandable but actionable information directly back to patients so that they can proactively intervene in their own condition. In summary then, I think that HeartLogic provides the opportunity to move into a new era of predictive maintenance for heart failure, move away from condition-based maintenance, only dealing with our patients when they're already sick, and also moving away from purely preventive maintenance where we're forcing patients to come into our offices on a regular basis whether they're needed or not. HeartLogic has validated in clinical trials high sensitivity for detecting heart failure events, a low alert rate for false alerts, and provides weeks of advance notice for patients ahead of a potential heart failure event, features that we see as increasingly important in a post-COVID pandemic world. Thanks a lot, Amber, and I'd be happy to take questions. Thank you so much, Dr. Stein, for that information. I think that HeartLogic, as we think about how we manage heart failure patients as clinicians, is certainly a tool in our toolkit that we've never had before. I think one of the questions that comes up frequently as we think about incorporating HeartLogic into our clinics is that this is a paradigm shift. As we go from reactive medicine to predictive medicine, how do we incorporate these alerts and being able to articulate the message to patients that we've gotten a message that something could be going on or some event is coming up in the future and we want to go ahead and intervene on that when the patients really could be feeling okay right now? I just wanted to get your thoughts around messaging and how you've seen clinics handle that in the real world. Yeah, Amber. Yeah, thanks. It's a really important point in that people are much more comfortable responding to symptoms than they are treating folks when they're pretty symptomatic. One of the things to emphasize is the design goal of this was to provide warnings before you got symptomatic. I think the way I like to think of it is we got no problem treating numbers when we're treating high cholesterol. You don't wait for someone to come into the emergency room with a heart attack before you put them on a statin. We got no problem treating numbers when we treat hypertension. You don't wait for someone to come into the emergency room with a splitting headache and a brain bleed before you treat their hypertension. We just got to get people more comfortable thinking about heart logic in that way. This is a number that we know predicts adverse outcomes and so there's no reason to have discomfort treating that number. Perfect. Perfect. I think that's a great way to think about it and it just helps to reframe how we as device clinicians look at this data and how we're able to speak to patients about that. I think one of the things in your presentation that I'm really most excited about is the opportunity for patients to be a part of their care team. Historically, device clinics and clinicians have owned the patient data and I think patients more and more are asking for that data and they want to have a little bit more control and have visibility to what's going on. I was just hoping you could elaborate a little bit more on how you see that looking like in the future with patients having access to that and really being involved with their care. Yeah. We already do have a patient app for our devices that gives them some limited information from latitude. I've been actually really pleased with the response to it. Actually, my dad has one of our devices and I have the app and I check his battery status every now and then. One of the things that we've done with that app already is provide push notifications to patients if they've lost their connection with remote monitoring. We found that to be really useful in getting people back on monitoring without them having to go via the device clinic or call our own technical support line. The idea here is let's just keep getting patients more engaged in their own care. You have to be sensitive. We can't overload patients with data just for the sake of data. It's got to be done in a way that the average patient can understand. We got to make sure that what we're providing is going to be actionable without unnecessarily causing anxiety or raising concerns. What we found, again, as we rolled out our initial version of the app, is that you can do that. I think we all need to have respect for patient autonomy and our patients' ability to understand this stuff and take care of themselves. I think that's perfect. One thing I think that we've really learned with the increase in app-based monitoring is that we often underestimate our patients and they're able to do so much more than we give them credit for. I'm excited to see where this space goes for Boston Scientific. I think lastly, I'd just like to touch on where you see that bridge between EP and heart failure. This device is one that provides data to both service lines. Thoughts around how we incorporate both of those teams into managing a patient so everybody's got the data they need when they need it. Yeah, right. The key is breaking down barriers because we've developed these silos of care. I know, again, when my dad was ill, he was, I'm not going to say where, he was hospitalized. It's a very complicated course of heart failure management. There was just this great team-based approach to care from structural heart physicians, electrophysiologists, the heart failure team, nephrologists, and everything was great through when he got his procedures done. Then after the procedures were done, for some odd reason, none of the doctors talked to each other anymore. We just got to break that down. Again, that's something where actually I see COVID in a really weird paradoxical way being helpful. We're getting more used to doing telehealth visits. When you do a telehealth visit, you don't have to only have one healthcare professional and one patient, Don. Again, it really makes it much more easy to do a team-based approach to care of your patients. Hopefully, if any good comes from this, it'll help us break down these artificial barriers that we've got just preventing good communication between device clinics and heart failure clinics. I agree completely. I couldn't agree more. Well, thanks very much for your time today and thanks everyone for tuning in. We appreciate it and hope you have a great rest of your day. Thank you, Amber. Same to you.

HeartLogic

heart failure diagnostic

automated predictive monitoring

physiologic sensors

heart failure decompensations