The American Heart Association (AHA) has issued a scientific statement cautioning against the premature use of cuffless blood pressure (BP) devices for hypertension diagnosis and management. While cuffless BP devices, such as smartwatches, rings, patches, and fingertip monitors, offer convenience and accessibility, they are not yet reliable enough for clinical use, according to the AHA.
Jordana B. Cohen, MD, MSCE, the statement's writing group chair, highlights a critical issue: many of these devices have not been adequately validated for accuracy or real-world use. As a result, clinicians and patients are encountering these devices without clear guidance on their limitations and potential risks. Cohen emphasizes the need for thorough validation to ensure these devices can accurately measure blood pressure in various real-world scenarios.
Despite the promise of cuffless devices, they face several challenges. These devices heavily rely on technology like sensors, algorithms, and data transmissions, which may not function optimally in resource-limited settings or areas with poor connectivity. Additionally, the FDA's clearance process does not guarantee accuracy for clinical use, as formal clinical validation testing is not required for clearance.
Gerald J. Jerome, PhD, a professor in the Department of Kinesiology at Towson University, notes that many cuffless devices have not been validated across diverse populations. This includes individuals with different skin tones, those with arrhythmias, and pregnant women. Jerome emphasizes the need for further research to confirm the accuracy of cuffless BP measurements in real-world conditions.
While cuffless devices may support patient engagement, validated cuff-based blood pressure measurement remains the clinical standard. Clinicians are advised to proactively ask patients about their use of wearable BP devices and help them interpret the readings appropriately. This includes explaining the limitations of cuffless devices and addressing any anxiety or false reassurance patients may experience.
In conclusion, the AHA's statement highlights the potential of cuffless BP devices but also underscores the need for careful validation and clinical research to ensure their accuracy and reliability in hypertension diagnosis and management.
