Late last month, Northwestern University and Johns Hopkins University announced they had received about $37 million from the National Heart, Lung and Blood Institute to study a new approach to stroke prevention in patients with atrial fibrillation, an irregular heart rhythm.
The funds will support the Rhythm Evaluation for AntiCoagulaTion (REACT-AF) trial, a seven-year study that will provide some patients with an Apple Watch to monitor for AFib. They’ll be able to take blood thinners in response to a prolonged episode, while patients in the control group will receive the current standard of care, continuously taking the drug to reduce stroke risk.
Dr. Rod Passman, director of the Center for Arrhythmia Research at Northwestern’s Feinberg School of Medicine and principal investigator of the study, sat down with MobiHealthNews to explain the upcoming research and how consumer devices could improve patient care.
MobiHealthNews: Can you explain the study design and what you’re hoping to learn from this research?
Dr. Rod Passman: We’re looking at the major problem of the most common abnormal heart rhythm, which is atrial fibrillation. We know that people with atrial fibrillation, particularly those with other cardiovascular risk factors like high blood pressure, are at a substantially increased risk of stroke.
The current approach is to take a blood thinner. If you apply the criteria for being on a blood thinner to the U.S. population with atrial fibrillation, maybe 80-plus percent of patients who have atrial fibrillation would be on these anticoagulants for the rest of their lives. We sort of have a one-size-fits-all approach. We treat people who are continuously in the abnormal rhythm with the same daily blood thinner as we do the individual who has one episode a year, or who has no further episodes because they’ve had an ablation done, or they’re on a drug, or they’ve lost weight, or they’ve stopped drinking alcohol.
So, I think this one-size-fits-all approach doesn’t make a lot of sense in an era where we can monitor people to see whether they’re truly having episodes. So, the goal here was to evaluate a paradigm shift, right? Instead of looking at individuals at risk, can we look at periods of risk? Can we treat at-risk patients with a targeted approach to being on a blood thinner, where they take it only for a few weeks and only in response to a multi-hour episode of atrial fibrillation?
MHN: If this method of continuous monitoring is validated by the study, how do you think this would improve upon the current standard of care?
Passman: From our estimates, this approach may apply to maybe half the population with atrial fibrillation. And what this means is that we can reduce the exposure to these medications, which are very effective at reducing stroke risk but are also contributors to both major and minor bleeding.
So, if we can protect people against stroke and minimize the exposure to the risks of the blood thinners, then we can improve the lives of our patients. And this has other implications, right? Not only would this be protective against stroke and reduce bleeding risk, but this would also, we believe, improve their quality of life because many patients curtail their activities. They may not go mountain biking or skiing because of the risks of trauma.
We also believe that this would be a cost savings to the healthcare system because these blood thinners can be costly and the cost of bleeding on these blood thinners is a major expense. So, if you can buy a device at your local electronics store for a fraction of the cost, this could not only improve quality of life, but do so at a lower cost.
MHN: Why did you choose to use a consumer device, the Apple Watch, for the study, as opposed to a clinical monitoring system?
Passman: We did two pilot studies, one using implantable cardiac monitors, and one using pacemakers and defibrillators. Those devices are very accurate in detecting atrial fibrillation. The problem is, the cost of using an implantable monitor for this indication is not scalable to the tens of millions of people around the world who may benefit from this approach.
More importantly, these devices are not patient-facing, they’re physician-facing. As your doctor, I may get the data from your implantable monitor, and I may get it a day later. A consumer electronics device is much more scalable, and the patient gets alerted when they have an episode.
Those issues allow us to ultimately make this point-of-care. This will be like a diabetic who checks their blood sugar, knows how much insulin to take in response to a particular level and can do that task without ever having to call their doctor. If this is a positive study, we hope that stroke prevention and atrial fibrillation follow a similar path.
MHN: You’ve done other research and written about wearables and digital health technology for this type of monitoring. What do you think are some of the obstacles to using these kinds of tools more broadly within the healthcare system?
Passman: From a patient perspective, there are still costs involved that may create barriers for some individuals. I do think that the healthcare system is not necessarily well-equipped to deal with the deluge of data that may be coming from these wearable devices that we may be asked to assess.
And I think in many cases, the technology is out there, but the pivotal trials showing that the use of this technology improves lives is still lacking. So, we believe that this study is a major step in critically evaluating a consumer-grade electronics device to show how we can leverage this technology that you can buy at Best Buy to save your life, reduce cost, and improve both how long you live and how well you live.
MHN: Some digital health technologies have clinical evidence behind them, but a lot of them do not. From a clinician’s perspective, does that make it difficult to recommend these tools to patients?
Passman: In the case of Apple, they and many companies have gone through rigorous evaluation of the technology to assess the accuracy. So, in many cases, these devices do perform in the way that we want them to. The Apple Heart Study and the Fitbit study are massive trials that I think did a really good job of evaluating can these devices do what they’re supposed to be doing.
But how we integrate this into care, and how we prove that giving patients these powerful tools impacts their journey through the healthcare system, those kinds of studies are lacking. I think that, in many cases, this technology has appeared faster than our ability to figure out how to integrate this into care.
The example I give is, in the traditional healthcare system, a doctor orders tests and then we get the results and we discuss with the patient. Digital health allows patients to give us the results of a test that we didn’t order. And we need to prove, as I suspect that we will, that that allows us to diagnose disease earlier to keep people at home and to manage their disease remotely.
But that will challenge the traditional healthcare system, where people come to an office appointment when they’re feeling well or an emergency department when they’re feeling poorly. We need to create the systems that allow us to take this information and manage patients remotely, and make sure that we are allowing this technology to keep patients away from the healthcare system.