When Stanford Center for Digital Health Executive Director Mintu Turakhia, MD, MAS, talks about wearable medical devices, he often returns to a few broad themes: the market—what the public is expecting and disruptive companies seem eager to provide; the questions that researchers will need to address to confirm that wearables actually have tangible, long-lasting benefits; and the obstacles that clinicians will need to hurdle as they weave the devices into healthcare delivery.
Wearable devices have captured the attention of both businesses and the public. Traditional healthcare companies and others want to capitalize on the surge of aging patients with chronic diseases, while both the healthy and the sick are intrigued enough to spend between $150 and $1,000 for a device to help them track their own health data. The interest of companies and customers alike, plus the FDA’s approval of a few devices’ medical-indicationmonitoring applications, has helped the market develop quickly with forecasts of 18 percent compound annual growth rates through 2026, according to Transparency Market Research.
Against that backdrop, Turakhia, who was co-principal investigator of the Apple Heart Study, points to questions and concerns that have emerged as patients strap on smart devices and then ask their physicians to evaluate voluminous
output. Reimbursement, for example, “tends to be a key driver of adoption in healthcare for any drug or device,” notes Turakhia. “There have been a few new codes for chronic care management and remote monitoring, but they have been slow to gain traction. So, how should we pay for monitoring with wearables?”
Other questions center around how so much data will be stored, secured and accessed, especially when clinicians are already deeply frustrated by the inadequacies of today’s electronic health records. “We’ve been talking about how everything should be housed in a common EHR, but very little has happened,” says Turakhia. “There is an opportunity for the personal health record to emerge as the standard, but where should we put the information obtained by wearables?”
The more fundamental challenge is determining which wearable data are actionable—which should, in theory, drive how the devices will be used for optimal results. The Apple Heart Study demonstrated that the Apple Heart algorithm was able to detect undiagnosed AFib in the real world and prompt patients to seek care. But a lot of research still needs to be done before we’ll understand how best to integrate sensor data into clinical care, Turakhia says.
How will the modern patchwork-style health system be able to absorb so much data from so many people? Not by operating as it does today, Turakhia says. “The way we think about arrhythmia care, for example, is not framed to the feedback loop of ongoing data or patient self-management,” emphasizes Turakhia, who also is a cardiac electrophysiologist. “So, how will cardiology get there?”
To tackle this and other questions swirling around consumer-level wearable devices, CVB brought together a panel of cardiologists who are helping to drive the movement. Fresh from presenting the Apple Heart Study at the ACC 2019 scientific sessions and participating in the HRS’s first Digital Health Summit, Turakhia accepted our invitation to moderate.
EARLY EFFORTS & OBSERVATIONS
Turakhia: Let’s start with thoughts on the areas where cardiology might get the most return from wearable devices and the challenges we’ll have to tackle. Dr. Mike Gibson has worked in this area for decades and now is chairing the HEARTLINE study, which aims to build on the findings of the Apple Heart Study. Mike, where do we have the most to gain with wearable technology?
Gibson: There is potential in many areas, including monitoring of arrhythmias, ischemia and heart failure. The idea of continuous monitoring isn’t new. Neither are the challenges. For 17 years, we worked on the Guardian implantable device, which monitored ST segments for heart attacks. At the time, regulators’ overarching concern was that monitoring someone continuously would create a flood of visits to the emergency room and a lot of false positives. At the end of the day, we saw a lower rate of false positive presentations with the use of the device and detected 44 new silent heart attacks in about 1,000 people.
It turns out you can improve not just the sensitivity of detecting bad cardiovascular things but also the specificity. That alignment of sensitivity and specificity will be very important for this field. The other major challenge will be helping regulators understand that these devices will not increase resource consumption and drive up healthcare costs; in fact, wearables might reduce costs and improve care.
Turakhia: So, where do we need to go following the Apple Heart Study? How should we define success for atrial fibrillation management? Dr. Khaldoun Tarakji has been a very early and thoughtful adopter of wearable technologies. Describe what have you accomplished and what have you learned.
Tarakji: Arrhythmia is a perfect application for wearables for a couple of reasons. First, we have need. In the U.S., approximately 3 million patients have AFib, and it’s only going to get worse as the population ages. And, second, the technology is capable of picking up heart rhythm recordings in an easy way with a patient’s smartphone. Unfortunately, discussions about wearables always seem to shift toward screening the healthy and whether we’ll raise anxiety. We tend to forget the ample opportunity we have to treat our existing patients. That’s what we’ve done so far at the Cleveland Clinic.
Wearables monitoring is particularly applicable to AFib patients. There are opportunities for diagnosis with intermittent symptomatic patients, for management when they need cardioversion and for follow-up after ablation.
We went through stages, beginning with small, simple studies of the products to learn about the technology and test what works and what doesn’t. Next, we tested the algorithms to see how well they detected AFib. And then we tried to embed the devices into our clinical practice.
What are our lessons so far? One is that the vast majority of patients will adopt this technology if you educate them. We also found the AI algorithms to be very good, but not perfect. Before changing management or making a clinical decision, a physician needs to confirm it. A third lesson came as we were working through this for clinical practice, with patients emailing rhythm recordings to us. We suddenly realized it’s just not sustainable. And, quite frankly, it could be dangerous. That’s what led us to build a workflow with only one product. Patients still record, but they don’t need to send us email. We just access their data on the cloud.
Another important takeaway is that wearables can positively impact patient care. We have many examples where we were able to make a diagnosis or do follow-up based on wearable data. For instance, you don’t need a transesophageal echo because the wearable showed you exactly when the patient went into AFib and he or she immediately started NOAC therapy.
Turakhia: Are there specific challenges that you are still struggling with?
Tarakji: One is reimbursement; there is no clear way to get paid. Another challenge is the platform. You do the work to set up a platform that works for one company’s products, but then other companies pop up. Do you keep building platforms? And, while this is a booming area and an investment in the future, we still need to take care of all our patients, including those who carry flip-phones.
CALL TO LEAD
Turakhia: New Bluetooth, low-energy implantable devices are on the brink. They can tell us a lot, but they don’t even let patients know how much AFib they have. So, patients go out and buy wearables. At the University of Southern California, Dr. Leslie Saxon has done amazing work on sharing complex implantable device data with patients in a user-friendly, digestible way. Leslie, walk us through the framework and philosophy that has guided your design principles of giving people access to their data.
Saxon: It’s an important civil right that patients have access to the entirety of their data in the same way that we have the right to our financial data. They have the right to attain their data in real time and in ways they can understand.
We’re still at a very early stage of development, but in no way is traditional cardiology or medicine leading this area. In fact, they’re incredibly defensive about it. At a time when 25 percent of America has a wearable, participants at the major cardiology meetings are focusing on how to conform the technology to an EMR that is probably the worst example of a digital storage platform in human history. We’re asking companies that created incredible disruption in cloud services to conform to an EMR that is the worst standard I can think of for usability, flexibility and all the things needed in an expandable digital platform.
I don’t think that we’ll end up with anything like our current EMR. I hope not, because the promise of this technology is a model of healthcare where our patients are continuously monitored with medicalgrade sensors. This digital platform will provide them not just with a diagnosis but also context and integration. They’re going to want on-demand education about their condition, which is another fundamental right. Many patients—even the most educated—are functionally medically illiterate. The challenge is figure out how to deliver digital education that is deeply personalized and ongoing within a continuous model that builds on the individual and provides both context and unprecedented integration.
Remember when iTunes completely changed the music business? Before iTunes came out in 2003, there was piracy. We could listen to songs without buying a record from the record labels, but there was no business model. Then iTunes completely changed digital music. We don’t have the iTunes of wearable technology yet. We’re at the stage of pirated songs—we can do medical-grade diagnosis for serious conditions that should be treated right away, but we have no way to organize and monetize it.
At the University of Southern California, our research relates to using wearables as a hub. Anything that’s connected on the body—whether it’s a highend implantable defibrillator or an Apple Watch—is a digital hub for disease management. What a patient cares about is not that they got a shock from their defibrillator but that they have heart failure. Someone else cares that they tried to be active and healthy. These are hubs that should be designed to allow people—as much and as holistically as possible—to take care of themselves and optimize themselves. The enormous potential is in the ability to help people achieve that goal.
Traditional medicine needs to start designing and innovating on these platforms. The EMR companies shouldn’t even be in the conversation because they’re largely irrelevant. Most of the data people will be collecting is going to be outside of the traditional medical system. How the integration will occur and what the ultimate EMR will look like are unknowns, but it can’t be what we’re using now.
Turakhia: We’ve just heard how medicine, including cardiology, is behind in this area. Dr. Nassir Marrouche is the chair of the Heart Rhythm Society’s digital task force. Nassir, would you speak to how HRS and other societies should help clinicians, hospitals, payers and others tackle these issues?
Marrouche: The societies’ role is to step up and start leading. How many of us have patients coming into clinics every week with their wearable data? “My heart rate is high. What do you think?” they ask. “I have irregular heartbeats on this device. I have two extra beats, according to this device.” They are telling us if their temperature or oxygen saturation was too low during specific activities. So far, it has been the patient, or the consumer, leading this wave.
I suspect that half of the providers in our clinics don’t want to deal with wearable technologies. The HRS leadership voted to confront this challenge. The first and biggest hurdle is to organize our members to face this challenge. The societies’ goal is to connect consumers with our providers. We had a great start with a full-day summit at Heart Rhythm 2019. We expected 150 to 200 attendees, and we had about 700 people. They came from every corner to listen. It’s not a choice for us anymore. It’s a must.
Now that we have providers’ attention, what are the challenges? First, massive amounts of data. Patients are sending it to us. The solutions—AI, adapting clinical workflows, having patients control their data and so on—need to be combined. Second, clinicians are spending so much time reviewing data from patients’ wearable devices and responding to them. Who is going to reimburse physicians for that work? Third, how much of the data should be believed? The Apple Heart Study was a step in the right direction, but the societies need to start working with CMS and the FDA, looking at this technology from their perspectives. We’re also taking the big step of co-writing a white paper with the Consumer Technology Association.
Let’s remember, this wave is not like the angioplasty wave and others we’ve seen in medicine. The wearables wave is being driven by consumers and industry, not by us. We must jump on the train and start tackling this.
VALIDATION & VISION
Turakhia: Let’s talk about evidence generation. Step one for devices is sensor assessment scales and sensor validation. In other words, does the device measure what it’s supposed to, and can it do so safely? On the opposite end of the continuum is showing that the device improves hard clinical outcomes. The HEARTLINE trial, which Mike is chairing and Janssen is sponsoring, is an example. Mike, can you tell us about HEARTLINE?
Gibson: HEARTLINE will be the largest randomized trial that I know of in the cardiovascular space, up to 180,000 patients. There are two goals. One is to see if we can detect AFib that may have previously been asymptomatic and undiagnosed and, if so, whether we can improve outcomes as a result of that detection. The second goal is to see if the device can help drive up adherence to NOACs or DOACs in patients who already have AFib. Patients who don’t have AFib and are over 65 will be randomized to use the Apple Watch (paired with the iPhone) vs. no Apple Watch. The primary endpoint is essentially a Kaplan Meier curve assessment of the timing of the AFib protection, as validated with a claims database. For the second endpoint, we’ll have a Kaplan Meier analysis of the time to meaningful cardiovascular events, such as reductions in death, myocardial infarction, stroke or rehospitalization for things like heart failure. We’re powered at 90 percent for the first endpoint. That’s much different than the incidence that was observed in the Apple Heart Study because we’re studying people who are older with higher risk of AFib. We’ll have about 80 percent power to detect the clinical outcomes. We’re trying to see not only if we can detect and diagnose the condition, but whether treating heretofore undiagnosed asymptomatic Afib improves outcomes. That’s the overarching healthcare question.
Turakhia: It’s a fantastic design, and we’ll eagerly await progress over the next few years. But what if you don’t hit the primary outcome of a hard endpoint, such as a reduction in stroke or other events? Does that mean we shouldn’t be using the device? Are there other tangible benefits and, if so, are they enough? Is empowering patients with their own data a positive benefit? Could we, for example, look at wearable devices as drivers of self-management, such as we have been doing with patients managing their diabetes with insulin? We take for granted that insulin can be a dangerous drug, but we let patients manage it themselves. The question is, must we show an improvement in hard outcomes for adoption? And if not, what are the other meaningful things that we can show along the way?
Marrouche: The answer is simple. If your loved one has AFib or high risk for AFib, would you buy them a wearable device? All of us would. We are in this world already. The fact is 80 percent of my AFib clinic patients have some kind of device. We are using devices like these to manage AFib on the phone, where you tell the patient to put the device on their chest or put their fingers on the device and it sends the data to me after two seconds. Or I tell them to take a flecainide and call me back in half an hour with a strip. It’s unbelievable for us as physicians to see this in action, but it’s happening right now. We’ll learn a lot from the HEARTLINE study, but these devices are here to stay. They’re replacing the Holter monitor. What do you need an event monitor for? Sadly, people doing event monitors today are doing it just because they get paid for it.
Saxon: The HEARTLINE study will be very important for a number of reasons. First, patients are getting their diagnoses. They’re getting more continuous assessment of their status. They’re able to fill in a lot of the blanks and connect a lot of the dots. Patients are their own best detective. They’re also getting data and context because their phone also maps their activity. We can integrate a scale, blood pressure and so on. We can even think about starting a NOAC in the future with appropriate screening and truly building a virtual care model where the physician is at the top of the pyramid. The great thing is we’d be like Captain Sully landing the plane on the Hudson River. We can practice at the top of our license. We’ll have super-educated and informed patients coming to us so we can actually spend time where we’re needed.
One of the things we’ve developed at USC is a virtual human me complete with voice-recognition and AI. I used current technology to scan myself as an expert. I answered 2,600 questions about AFib that we then programmed into the virtual me. It's an AI decision tree. If you download my agent through an app, you get me answering questions, such as “Why do I have AFib?” and “What’s the incidence?” There’s an audit trail that remembers individual patients and can eventually assess the emotion in their voice and understand other things about them. It remembers who they are and can ask a series of personalized questions. It’s their virtual care doctor.
The AI engine can do a lot. Maybe it doesn’t have to be a virtual me. It could be a bot or a text. That’s not important. The concept is that patients will get virtual care to a certain point and eventually they’ll get a human. But they’ll be very well cared for. These are the kinds of systems that we need to develop. In the meantime, the discoveries from HEARTLINE—how AFib occurs per population, per gender, per region, and other things we have no idea about yet—are going to lead to massive and logarithmically faster discovery about what AFib is and why it occurs.
Turakhia: Let’s take both of these points to the next level. Say you have a watch that measures something and says, “I think you might have an irregular rhythm or signs of another condition.” Right now, we’re patching this thing together—connecting people through the EHR, finding providers, getting patients’ data. But the real opportunity is building a stack for the patient to just press a button on his or her phone and be connected directly to a telehealth doctor or another trained professional, who will give the care he or she needs. The Apple Heart Study showed that we could use telehealth at scale and conduct physician-administered study visits.
I see care virtualizing in a couple of ways. One is overall telehealth. The other is software as a service, where patients pay a couple of bucks a month for hypertension or heart failure care. This might be a subscription model, similar to how we consume media. Thinking about the many stakeholders in cardiology, how could we scale these systems? And is doing so an opportunity, a threat or both?
Tarakji: I couldn’t agree more. We all have patients who travel long distances only for us to tell them, “Everything’s OK. Just keep doing what you’re doing.” That’s what led us to offering virtual visits. But my take on it is that virtual visits are simply glorified FaceTime or phone conversations, but now we have the tools and wearables to make a virtual visit even better than an in-person visit with a single ECG at the time of the visit. How satisfying is it to log in, see all of the recordings of your longtime patients and have data over multiple days? You don’t need to do this all the time, but when it’s time for follow-up or they need to connect with you, it’s great.
The hospital administration may ask if we’re losing opportunities because patients aren’t getting an ECG at the hospital. Well, patient experience matters, and we all need to be trying to ensure that the experience is great for the patient. They are grateful they did not have to travel, and they’ll continue to follow up with us, as opposed to not to following up with us, and they feel connected.
The flip side, which we should not lose sight of, is that a wearable device does not equal a wearable physician. That’s the concern, that every time a patient gets a rhythm recording through their smartwatch or smart device, they’re going to connect with their physician. Not so—with guidelines and candid discussion, we can set patients’ expectations right from the beginning.
As far as the wearable we choose to use, we need validation studies because we’ve seen bad examples with technology lacking validation and ending up with complete failure. But between validation studies and studies like HEARTLINE looking at hard outcomes, we have many opportunities to continue to use these wearable devices in a successful way.
Saxon: Yes, but how many hospital systems are asking questions like, “What’s our strategic plan for digital care? What licensing deals are we doing with tech companies? What’s our cybersecurity plan? Are we just going to be a traditional facility doing operations, or are we looking at the future?”?
How many systems are really looking to evolve toward software as a service or licensing deals with tech companies. Not many are really embracing the future in that way, which makes you wonder who will be leading all of this.
There are limitations on tech companies, and on us, too. Look at the limitations on telehealth. We can’t go out of state. So, how do we extend our barriers? Even now it’s unwieldy. We call patients all the time, regardless of where they are. They’re our patients! But it doesn’t feel like we’re really on top of it.
Gibson: There is a lot of tension between hospitals and physicians over what’s happening now. There are efforts at major hospitals to create healthcare navigators—telehealth staff who are available to chat with patients and are using algorithms designed by experts to manage lipids, blood pressure and heart failure. Physicians are pushing back, saying “Hold on! What am I supposed to do if this person who just graduated from college is just following an algorithm to adjust medications? What’s my role as a physician?” It has created unease. But maybe relieving physicians of some of that work will allow them to better function at the top of license, having the time to intervene in more meaningful ways.
But it is a moment of dramatic change. The big points that need to be addressed are who’s in charge and who’s driving it. Ultimately, consumers and patients will drive it. Physicians are distracted from playing the proactive role of shaping the future. And that for me is one of the bigger tragedies.
Turakhia: What is your vision for approximately 15 years from now? Specifically, how do you think the patient’s journey will look different for the detection and treatment of cardiovascular disease?
Gibson: We are emerging from an era where we had a paternalistic view of medicine, a one-way conversation from physician to patient. The physician knew best and was the repository of all knowledge. We’ve shifted to a two-way conversation, where patients are more empowered and have access to the repository of data and information. That is only going to grow and become more powerful. It will make us uneasy, but physicians will have to accept that this is the era of the empowered patient and shared decision making, where data is coming not just from the hospital but also from wearable and implantable devices. We will have to adapt to this new relationship with patients and wearables in healthcare.
Saxon: We have an unprecedented opportunity to leverage patients in their own care. There’s nothing more important to people than their own health or that of a loved one. We have to help them tell their story. The great promise is we can create a global healthcare system that doesn’t require a physical infrastructure and actually meet the health needs of many more people on earth. The scary part is around data ethics and cybersecurity, but a lot of other great things could happen with digital health.
Marrouche: We are shifting medicine toward prevention because of wearables. Because of wearables, we are going to see patients before they have persistent AFib, three-vessel disease or severe sleep apnea. That’s my hope for this technology. It’s already changing the way we see our patients. For the young people going to medical school today, that’s their standard. That’s the promise and I hope, at the end of the day, it will prevent and treat diseases.
Tarakji: I agree, it will be a paradigm shift in the patient-physician relationship. But it must be a partnership, with some expectations for the patients. It needs to be a shared responsibility. These technologies need to be an asset to physicians with meaningful impact and not simply added burden. You can’t have it both ways with these tools. It will evolve over time, and probably needs to be embedded in our medical schools.
The other point that I’m passionate about is the opportunities that we have globally because of the things we can do with wearables. We can bring healthcare up to a different level in countries with limited resources. It’s exciting. We will see what happens. It’s a movement.