Wearing a cuffless device on the wrist to continuously monitor blood pressure (BP) was associated with a significantly lower systolic BP at 6 months among hypertensive adults, real-world results from Europe show.
“We don’t know what they did to reduce their blood pressure,” Jay Shah, MD, Division of Cardiology, Mayo Clinic Arizona in Phoenix, told theheart.org | Medscape Cardiology.
“The idea is that because they were exposed to their data on a continual basis, that may have prompted them to do something that led to an improvement in their blood pressure, whether it be exercise more, go to their doctor or change their medication,” said Shah, who is also chief medical officer for Aktiia.
Shah presented the study at the American Heart Association (AHA) Hypertension Scientific Sessions 2022 in San Diego.
The study used the Aktiia 24/7 BP monitor; Atkiia funded the trial. The monitor passively and continually monitors BP values from photoplethysmography signals collected via optical sensors at the wrist.
After initial individualized calibration using a cuff-based reference, BP measurements are displayed on a smartphone app, allowing users to consistently monitor their own BP for long periods of time.
Aktiia received CE mark in Europe in January 2021 and is currently under review by the US Food and Drug Administration (FDA).
Shah and colleagues analyzed systolic BP (SBP) trends among 838 real-world Aktiia users in Europe (age 57 ± 11 years; 14% women) who consistently used the monitor for 6 months.
Altogether, they had data on 375 (± 287) app interactions, 3646 (± 1417) cuffless readings per user, and 9 (± 7) cuff readings per user.
Traditional cuff SBP averages were calculated monthly and compared with the SBP average of the first month. A t-test analysis was used to detect the difference in SBP between the first and successive months.
On the basis of the mean SBP calculated over 6 months, 136 participants were hypertensive (SBP > 140 mm Hg) and the rest had SBP < 140 mm Hg.
Hypertensive users saw a statistically significant reduction in SBP of -3.2 mm Hg (95% CI, -0.70 to -5.59; P < .02), beginning at 3 months of continual cuffless BP monitoring, which was sustained through 6 months.
Among users with SBP < 140 mm Hg, the mean SBP remained unchanged.
“The magnitude of improvement might look modest, but even a 5 mm Hg reduction in systolic BP correlates to a 10% decrease in cardiovascular risk,” Shah told theheart.org | Medscape Cardiology.
He noted that “one of the major hurdles is that people may not be aware they have high blood pressure because they don’t feel it. And with a regular cuff, they’ll only see that number when they actually check their blood pressure, which is extremely rare, even for people who have hypertension.”
“Having the ability to show someone their continual blood pressure picture really empowers them to do something to make changes and to be aware, and to be a more active participant in their health,” Shah said.
He said that a good analogy is diabetes management, which has transitioned from single finger-stick glucose monitoring to continuous glucose monitoring that provides a complete 24/7 picture of glucose levels.
Offering perspective on the study, Harlan Krumholz, MD, SM, with Yale New Haven Hospital and Yale School of Medicine, New Haven, Connecticut, said that having an accurate, affordable, unobtrusive cuffless continuous BP monitor would “transform” BP management.
“This could unlock an era of precision BP management with empowerment of patients to view and act on their numbers,” Krumholz told theheart.org | Medscape Cardiology.
“We need data to be confident in the devices — and then research to best leverage the streams of information — and strategies to optimize its use in practice,” Krumholz added.
“Like any new innovation, we need to mitigate risks and monitor for unintended adverse consequences, but I am bullish on the future of cuffless continuous BP monitors,” Krumholz said.
Krumholz said that he “applauds Aktiia for doing studies that assess the effect of the information they are producing on BP over time. We need to know that new approaches not only generate valid information, but that they can improve health.”
Ready for Prime Time?
In June, as reported by theheart.org | Medscape Cardiology, the European Society of Hypertension issued a statement noting that cuffless BP measurement is a fast-growing and promising field with considerable potential for improving hypertension awareness, management, and control, but because the accuracy of these new devices has not yet been validated, they are not yet suitable for clinical use.
Also providing perspective, Stephen Juraschek, MD, PhD, research director, Hypertension Center of Excellence at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston said that “There is a lot of interest in cuffless BP monitors due to their ease of measurement, comfort, and ability to obtain BP measurements in multiple settings and environments and this study showed that the monitoring improved BP over time.”
“It is believed that the increased awareness and feedback may promote healthier behaviors aimed at lowering BP. However, this result should not be conflated with the accuracy of these monitors,” Juraschek cautioned.
He also noted that there is still no formally approved validation protocol by the Association for the Advancement of Medical Instrumentation.
“While a number of cuffless devices are cleared by the FDA through its 510k mechanism (i.e. demonstration of device equivalence), there is no formal stamp of approval or attestation that the measurements are accurate,” Juraschek told theheart.org | Medscape Cardiology.
In his view, “More work is needed to understand the validity of these devices. For now, validated, cuff-based home devices are recommended for BP measurement at home, while further work is done to determine the accuracy of these cuffless technologies.”
The study was funded by Aktiia. Shah is an employee of the company. Krumholz has no relevant disclosures. Juraschek is a member of the V alidate BP review committee and the AAMI sphygmomanometer committee.
American Heart Association (AHA) Hypertension Scientific Sessions 2022. Presented September 9, 2022. Poster: 302.
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