Late last month, Northwestern University and Johns Hopkins University announced they had received about 37 million dollars from the National Heart, Lung, and Blood Institute to study a new approach to stroke prevention in patients with atrial fibrillation, an irregular heartbeat.
The money will support the Rhythmic Assessment for AntiCoagulaTion (REAT-AF) trial, a 7-year study that will provide some patients with an Apple Watch to monitor AFib. They will be able to take blood thinners to deal with a prolonged episode, while patients in the control group will receive the current standard of care, continuing to take medication to reduce stroke risk.
Dr. Rod Passman, director of the Heart Arrhythmia Research Center at Northwestern’s Feinberg School of Medicine and principal investigator of the study, sat down with MobiHealthNews to explain upcoming research and how consumer devices can improve patient care.
MobiHealthNews: Can you explain the study design and what you hope to learn from this study?
Dr. Rod Passman: We are looking at the main problem of the most common irregular heartbeat, which is atrial fibrillation. We know that people with atrial fibrillation, especially those with other cardiovascular risk factors such as high blood pressure, have a significantly increased risk of stroke.
The current approach is to take blood thinners. If you apply the blood-thinning criteria to the U.S. population with atrial fibrillation, it is possible that more than 80% of patients with atrial fibrillation will require these anticoagulants for the rest of their lives. . We have a one-size-fits-all approach. We treat people with persistent irregular rhythms with daily blood thinning just like we do for people who have one episode per year or who don’t have another episode because they’ve had ablation or are being treated with medicine. , or they have lost weight, or they have stopped drinking.
So I think this one-size-fits-all approach doesn’t make much sense in an age where we can track people to see if they really have multiple episodes. So the goal here is to evaluate the 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 blood thinner approach, where they only take the drug for a few weeks and only in response to a single episode of atrial fibrillation lasting several hours?
MHN: If this method of continuous monitoring is validated by research, how do you think this will improve compared to current standards of care?
Passers: In our estimation, this method is applicable to half of the population with atrial fibrillation. And this means we can reduce our exposure to these drugs, which are very effective at reducing stroke risk but also contribute to both major and minor bleeding.
So if we can protect people against stroke and reduce the risk of blood thinners, then we can improve patients’ lives. And this means something else, right? Not only does this help protect against stroke and reduce the risk of bleeding, but we believe it improves their quality of life as many patients limit their activities. They must not go mountain biking or skiing because of the risk of injury.
We also believe this will be a cost saving for the healthcare system as these blood thinners can be expensive and the cost of hemostasis on these blood thinners is a major expense. . So, if you can buy a device at a local electronics store for a lower cost, this can not only improve your quality of life, but also at a lower cost.
MHN: Why would you choose to use a consumer device, the Apple Watch, for research, instead of a clinical monitoring system?
Passers: We performed two pilot studies, one using implanted heart 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 screen for this indication is not scalable to the tens of millions of people around the world who could benefit from this approach.
More importantly, these devices are not directed at the patient, they are directed at the doctor. As your doctor, I can get the data from your implant and I can get it a day later. A consumer electronic device is much more scalable and patients will be notified when they have an episode.
Those issues allow us to finally make this point. This would be like a diabetic patient checking their blood sugar, knowing how much insulin is needed to respond to a particular level and being able to perform that task without having to call their doctor. . If this is a good study, we hope that preventing stroke and atrial fibrillation goes the same way.
MHN: You have completed other research and write about wearables and digital health technology for this type of monitoring. What do you think are some of the obstacles to using these types of tools more widely in the healthcare system?
Passers: From a patient perspective, there are still costs involved that can create barriers for some individuals. I think the healthcare system is not necessarily well equipped to deal with the large amount of data that may come from these wearables that we may be asked to evaluate.
And I think in many cases, the technology has been born, but the important tests that show that using this technology improves lives are still lacking. Therefore, we believe this study is an important step in critically evaluating a consumer electronic device to show how we can leverage this technology that you can buy at Best Buy to Save life, reduce cost and improve your life time. and how well you live.
MHN: Some digital health technologies have clinical evidence behind them, but a lot of them don’t. From a physician’s perspective, does that make it difficult to recommend these devices to patients?
Passers: In the case of Apple, they and many companies have undergone rigorous due diligence on the technology to assess accuracy. So, in many cases, these devices work the way we want them to. The Study on the heart of the apple and Fitbit Research are big tests that I think have done a really good job at assessing whether these devices do what they’re supposed to do.
But how do we integrate this into care, and how do we demonstrate that providing patients with these powerful tools impacts their journey through the healthcare system, That research is still lacking. I think, in many cases, this technology has emerged faster than we have been able to figure out how to integrate this technology into care.
The example I gave is, in the traditional healthcare system, the doctor orders tests and then we get the results and discuss them with the patient. Digital Wellbeing allows patients to provide us with the results of a test we did not request. And we need to demonstrate, as I suspect, that we will be able to demonstrate that allows us to diagnose diseases earlier to keep people at home and manage their illnesses remotely.
But that would challenge the traditional health care system, where people go to the clinic when feeling well or to the emergency room when feeling poorly. We need to create systems that allow us to retrieve this information and manage patients remotely, while ensuring that we are enabling this technology to keep patients away from the healthcare system.