The popular Apple Watch qualified for the U.S. Food and Drug Administration’s (FDA) Medical Device Development Tools program on May 1 due to its Atrial Fibrillation (AFib) History feature. The smartwatch is the first digital health device to qualify for the agency’s program, enabling researchers to use the feature in clinical trials to detect heart arrhythmias.
The FDA announced that the watch’s feature is a noninvasive way to collect AFib data, adding that it is “designed to be used as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices.”
The AFib feature monitors changes in blood flow at the wrist while measuring intervals between heartbeats. It then analyzes the intervals to estimate how long the person may have been in AFib the previous week. The Apple Watch must be worn at least 12 hours a day, five days a week, to record consistent estimates.
What Is AFib?
According to the American Heart Association, atrial fibrillation occurs when the heart beats irregularly (arrhythmia). The condition can lead to blood clots, stroke, or heart failure. Untreated AFib doubles the risk of heart-related deaths and is associated with a fivefold increased risk of stroke. The U.S. Centers for Disease Control and Prevention (CDC) reports that more than 12 million people will have AFib by 2030.Too Much Information?
Some physicians wonder if access to real-time data could add to patient anxiety. In a 2020 Cardiovascular Digital Health Journal article, researchers from the University of North Carolina at Chapel Hill and Yale School of Medicine noted that while such tools “undoubtedly will transform health care and energize scientific research, important ethical, legal, and social issues have been raised and require careful public deliberation.”Expressly, the researchers point out that patients with AFib who are constantly monitoring their heart rates are susceptible to increased anxiety and unnecessary medical care. The authors describe a case of a 70-year-old woman with AFib whose anxiety was “primarily triggered by excessive cardiac monitoring with a commercially available smartwatch.” The woman had no previous mental health problems, according to the authors.
“It became apparent that our patient had developed an enduring belief that smartwatch notifications were a sign of worsening cardiac function, leading to a vicious cycle of excessive worry, preoccupation with cardiac stimuli and sensations, and compensatory behaviors,” which included habitually checking her smartwatch and needing repeated reassurance from health care professionals.
The woman’s constant worry and frequent health care checkups profoundly impacted her relationships, mental health, and overall quality of life, the authors noted.
“Wearables can play an important role in promoting patient empowerment and health care engagement. However, this will require active involvement and strong collaboration among all stakeholders” to understand how different populations, such as older people, will interact with the technology, they wrote.
