Cuffless blood pressure measurement devices: Convenient, but not ready for clinical use
Cuffless blood pressure (BP) measurement devices could provide significant value for clinicians and patients alike. However, according to an in-depth analysis published in JAMA Cardiology, these devices are not yet ready for clinical use because too many unanswered questions remain.[1]
“Cuffless BP measurement devices offer advantages over validated cuffed devices, including greater comfort and convenience, BP measurement without upper arm sizing or positioning and continuous BP measurements over extended periods,” wrote first author Eugene Yang, MD, MS, a cardiologist with the University of Washington School of Medicine, and colleagues. “Cuffless devices may also be less expensive, improving consumer access, especially in low- and middle-income countries (LMIC), where cost may be a determinant. Although the availability of cuffless BP measurement devices has increased, validation of device readings for accuracy has not been addressed.”
Yang et al. reviewed the various cuffless devices designed to provide users with quick BP measurements. This includes everything from wrist-worn watches and smart rings to chest patches and even a toilet seat. These devices use a variety of signal sensors, artificial intelligence algorithms and other technologies to obtain their measurements—but, as the researchers observed, it has been challenging to determine just how accurate and useful they are from a clinical perspective due to the lack of proper validation.
“Although some companies have published studies demonstrating device accuracy, they generally compare their devices to intra-arterial or sitting BP, which are not appropriate for validation,” the authors wrote. “Although manufacturers claim their devices are accurate, independent researchers have generally not reached similar conclusions. External validation of these devices is critically important, especially since cuffless technologies are continuously evolving.”
These devices have also been linked to several limitations over the years. A patient’s skin tone could impact accuracy, for example, or even something like taking BP-lowering medications could throw off a measurement. These issues, the group wrote, “should not be ignored.”
Considering the patient’s perspective
Yang and colleagues also examined the rise of cuffless BP measurement devices from a patient’s perspective, noting that traditional devices with cuffs are associated with different limitations of their own. Patients dislike using these devices, for example, and incorrect cuff sizing can result in significant errors. These limitations highlight why cuffless BP measurements offers so much potential for patients; it increases the likelihood of a patient following through and tracking their own BP when recommended by a healthcare providers.
“Patient perspectives are important in adopting new technologies such as cuffless BP devices,” the authors wrote. “Self-monitoring facilitated by these technologies empowers and increases engagement by patients in their healthcare. Empowerment experienced by patients with technology-enabled care enhanced their ability to participate in decision-making, achieve control, learn about their health, and experience less frustration with technology.”
Even if patients prefer the idea of cuffless measurements, however, the technology is not yet readily available to all populations. In LMIC, for example, “socioeconomic barriers may limit their successful update.”
How clinicians view these cuffless technologies
Accuracy is not the only concern for clinicians, the group explained. The large amount of data necessary for monitoring a patient’s BP from home is something else health systems must consider. Secure cloud-based storage offers promise, but it requires a lot of planning to get something that involved up and running.
“Insufficient reimbursement is another barrier to greater adoption of out-of-office BP monitoring in the U.S.,” the authors added. “It will be essential to create appropriate reimbursement models for clinicians managing patients with frequent readings from cuffless BP devices, with safeguards in place to ensure that billing codes are not misused.”
According to Yang et al. “perhaps the most important concern regarding cuffless BP devices relates to potential misuse by clinicians.”
“Recent studies have documented that 75% to 80% of home BP devices and 100% of the studied cuffless devices available for consumer purchase were not validated for accuracy,” they explained. “Many clinicians lack awareness of validation issues with existing BP devices. In the U.S., there is a poor understanding of the difference between FDA clearance, which only indicates safety and equivalence with similar consumer devices, and FDA validation, which refers to passing an exacting validation protocol demonstrating accuracy. Hypertension experts have been raising the alarm regarding unvalidated BP devices, including cuffless BP devices, and the need for new policies and regulations to decrease their use.”
Looking ahead at cuffless BP devices
The group concluded its analysis by looking forward to the research that is still needed before cardiologists start to fully embrace cuffless BP measurements. More studies need to compare cuffless devices to ambulatory BP monitoring and home BP monitoring, for example, to ensure shifting to this technology would not result in a drop in quality.
Clinician education is another area where improvement is needed. The group emphasized that cardiologists and other healthcare providers must only recommend validated BP measurement devices because FDA approval is not enough.
Click here for the full analysis, which features input from co-authors all over the world.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.