By Dr. Robert Lerman

When the preliminary results of the Apple Heart Study were presented at the 2019 Scientific Sessions of the American College of Cardiology, they created quite a stir. This research trial, which included more than 400,000 participants self-enrolled over the internet, demonstrated the ability of wearable technology to detect atrial fibrillation (afib), a leading cause of stroke and hospitalization in the U.S. Suddenly, the lines began to blur between wearable devices used largely for fitness monitoring and health awareness and true medical devices used to detect and monitor disease. The promise was clear, that the current model of episodic intermittent care could someday be replaced with continuous remote monitoring of multiple physiologic parameters using easily accessible, user-friendly consumer technology that might prevent disease before it strikes.

Almost immediately, however, the predictable backlash ensued. Critics cautioned the study was not a randomized control study, the gold standard of clinical research, so it couldn’t provide any insight into the device’s real impact on health. There may be many false positive alerts, in which the watch delivers an alert to people who do not have atrial fibrillation, causing a huge burden on our already overburdened health care system, or false negatives where the watch misses true episodes of atrial fibrillation. The harms of potential treatments could outweigh any benefits of stroke reduction.

So where do we draw the line between hype and hope?
We may find some clues in another area of cardiology where clinicians have been struggling to implement the promise of remote patient monitoring. Remote monitoring of patients with implantable cardiac devices such as pacemakers and implantable defibrillators took a giant leap forward in 2001, when devices paired with bedside home transmitters were developed that could communicate with each other wirelessly, using radiofrequency energy. This allowed the implantable devices to transmit data automatically if certain abnormal criteria were detected. These “alerts” were easily accessible by clinicians through a dedicated web portal. The remote monitoring alerts informed clinicians about changes in device function or new abnormal heart rhythms that might have otherwise gone undetected until the patient’s next office visit. Nonetheless, adoption of remote monitoring has been much slower than anticipated. Some of the same factors that impact adoption of remote monitoring in this population may provide perspective on the road ahead for the larger populations involved in consumer wearables.

The first question to ask for any medical device is whether the results are accurate. While alerts generated by pacemakers and implantable defibrillators tend to be quite accurate, the same cannot always be said for the small, implantable cardiac monitors used for diagnosing abnormal heart rhythms. These “Implantable Loop Recorders (ILRs)” have represented a major step forward in the diagnosis of intermittent heart rhythm problems, but they can be plagued by frequent false positive alerts, which strain the resources of cardiology clinics. While the accuracy of the Apple Watch in the study was encouraging, much work is yet to be done, and even a small percentage of false positives applied to a huge population could create tremendous increased utilization of healthcare resources. Improved algorithms, careful programming, and proper patient selection can all reduce the number of false positives for ILRs, and similar principles should apply to consumer wearables.

The next question to ask is, given that the data is accurate, is it actionable? One of the biggest controversies in cardiology is how to best minimize the risk of stroke in patients with afib, caused by development of blood clots in the heart. We know that blood thinning medication is effective in preventing stroke in patients with afib, but no one knows how long a patient has to be in afib before development of a blood clot is a risk.

Data from remote monitoring of patients with pacemakers and defibrillators has, for the first time, given us an almost continuous view of how many episodes of afib patients have and how long they last. What isn’t known is whether treating patients based on these episodes that often occur without symptoms is any better than treatment based on symptoms or diagnosis that occurs during a physical examination. More data is probably better, but we still need to prove it.

Next, assuming these devices generate important data, are there people available to view and act on the results? Alerts for implantable cardiac devices are largely directed toward clinicians, as opposed to the patients themselves. However, there may not be dedicated staff or workflows designed to consistently review the data that is sent by devices remotely. Although clinical trials clearly demonstrate improved outcomes with remote monitoring, none of these benefits are realized if no one is looking at the data.

Many consumer-oriented technologies focus on delivering information to the patient instead of the physician. In the Apple Watch study, users were notified of possible afib if their pulse was irregular. It was then incumbent on the individual to contact a physician for further evaluation. While this example removes the burden of having clinical staff continuously monitor the patients’ heart rhythm, it remains to be seen how much more effective that will be than the pacemaker audible alert. In the Apple Watch study, only 57% of patients who received a notification actually sought medical attention.

Patient access to data is another challenge — and opportunity. Patients have access to more of their data than ever before. From wearables and consumer products like home blood pressure cuffs to patient portals, patients can view lab tests, imaging results, and physiological parameters often before their own doctors. While patients feel empowered by this access, the healthcare community finds itself playing catch-up. How much information is helpful, and when does it become harmful to patients? How do healthcare providers manage patients’ expectations for “all access?”

Again the evolution of data from cardiac implantable devices can be informative. Patients with pacemakers and implantable defibrillators have become more proactive about requesting the data generated by their device. While remote monitoring often eliminates the burden of traveling to their physician’s office and waiting to be seen, it also eliminates the immediate feedback of being told that everything is working properly. Instead, remote device data is often sent automatically without the patient’s knowledge, and clinician workflows have not always evolved to deliver prompt feedback to the patients at home. While some are satisfied to be told that “no news is good news,” patients increasingly want more details. At the same time, while some physicians are comfortable with cardiac device data being available on a patient portal, the complexity of the reports and the lack of overall clinical context may generate anxiety, a deluge of phone calls, or both. As more data are available from a broader spectrum of devices addressing a wider area of medical problems, these concerns and conflicts will increase exponentially.

Finally, interoperability of information systems is required in order for data to be truly useful to both physicians and patients. While Electronic Health Records (EHRs) can provide a single repository of information to enable timely access by health care providers and to empower patients, these benefits have largely not materialized. Data are frequently siloed within separate systems that don’t talk to each other. Cardiac device clinic nurses must access three to four different manufacturer web portals to evaluate remote monitoring data, and it is often difficult to get the information into the EHR. Any dramatic expansion of consumer wearables into the clinical arena must be accompanied by a solution that allows both clinicians and patients to view all data in one place.

Lloyd Minor, M.D., dean of the Stanford School of Medicine said, “The results of the Apple Heart Study highlight the potential role that innovative digital technology can play in creating more predictive and preventive healthcare. Atrial fibrillation is just the beginning.” Nonetheless, there is still a lot of work to be done before wearables are ready to take their place alongside medical devices. Mintu Turakhia, M.D., associate professor of cardiovascular medicine at Stanford School of Medicine, and a principal investigator of the Apple Watch study, said, “We’re in the first half of the first inning.” Based on the experience with implantable cardiac devices, data accuracy, determination of whether data is truly actionable, workflow design to ensure consistent data monitoring, patient data access, and interoperability are all challenges that will need to be addressed in coming years.

About the author: Robert Lerman, M.D. is a senior physician executive currently serving as chief medical officer and VP of Clinical Operations for LindaCare, a digital health company specializing in integrated remote monitoring software solutions for chronic disease management. His experience includes both clinical training as an electrophysiologist as well as administration serving as VP of Supply Chain Clinical Services for Dignity Health.