Researchers at Northwestern University and John Hopkins University plan to study if an Apple Watch app can help prevent strokes.
The National Heart, Lung, and Blood Institute, a National Institutes of Health division, awarded a $37 million grant for researchers to test whether Apple Watches can be used as part of a strategy to cut down the use of expensive blood thinners used to prevent strokes from atrial fibrillation.
The American Heart Association, Johns Hopkins, Stanford, and the University of California, San Francisco, are also partners on the study,
Afib is the most common heart rhythm disorder in adults, affecting 2.5 to 5 million Americans. That number is estimated to grow to 12.1 million by 2030. Worldwide, the estimated number of individuals with afib in 2010 was 33.5 million, according to a 2013 study.
The new NIH-funded trial will incorporate the use of an app on Apple Watch to monitor afib to attempt to reduce patients’ continuous and lifelong reliance on blood-thinning medication.
The seven-year study, expected to launch next spring, will recruit 5,400 patients who will receive standard afib care of blood thinners or Apple Watch-directed treatment.
The trial will also examine whether the app can reduce major bleeding events compared to continuous therapy, according to a Northwestern press release.
Using the app on Apple Watch and an accompanying app on iPhone, patients in the trial will be able to target blood-thinning medication use for a limited period of time and only in response to a prolonged episode of afib. The study could ensure patients only take blood thinner medication when they’re at a high risk of stroke, according to researchers.
“If proven effective, this new treatment paradigm will fundamentally change the standard of care for the millions of Americans living with AFib,” said principal investigator Dr. Rod Passman, director of the Center for Arrhythmia Research and a professor of medicine in the division of cardiology at Feinberg, in a press release.
“Many of these patients are on blood thinners for the rest of their lives even if they have infrequent episodes of atrial fibrillation,” Passman said. “If we can show this strategy is equally protective against stroke and reduces bleeding, that could save lives, reduce cost and improve quality of life.”
For eight years, Passman has been studying solutions to end the standard “one-size-fits-all” practice of prescribing lifelong blood thinners (anticoagulants) to everyone with afib.
Afib is a heart rhythm disorder characterized by fast and irregular heartbeats from the upper chambers of the heart. People with afib have increased risk of stroke, so many are continuously treated with blood-thinning medication to reduce that risk. But this treatment also raises the risk of bleeding, according to Passman, and balancing the risks and benefits can be challenging for both patients and physicians.
However, some patients with afib have infrequent episodes of irregular heart rhythm either on their own or as the result of medications or procedures. Current evidence suggests the risk of stroke increases in the weeks following an episode of afib then returns to a baseline, raising the possibility of intermittent blood-thinner treatment.
Since many individuals have no symptoms during an episode of afib, the new trial will employ Apple Watch to monitor heart activity, notify patients when they’re entering an afib episode and limit the length of time on blood thinners only to the high-risk period for stroke
This “pill-in-pocket” approach could protect patients against stroke while reducing bleeding events and the cost of afib treatment, Passman said.
“We think advances in technology will allow us to personalize this care,” Passman said. “Why should patients expose themselves to the risk and cost of these drugs when they may not be benefiting?”
A secondary aim of the study is to measure patient satisfaction and health care resource utilization.
If successful, the trial could be a boon to Apple's healthcare ambitions as the company touts the heart-related features of its wearable device.
Apple has been steadily building out the health features of its smartwatch. In 2018, the latest iteration of Apple’s smartwatch included an FDA-cleared electrocardiogram, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms, Fierce Medtech's Conor Hale reported.
Features on the Apple Watch include FDA-cleared built-in ECG and irregular rhythm notifications, which can identify and alert users to potential signs of atrial fibrillation.
The Apple Watch has previously been used as part of an Apple Heart Study in collaboration with Stanford Medicine.