Continuous Cuffless Monitoring May Fuel Efforts to Lower BP

Use of a wristless cuff device to continuously monitor blood pressure (BP) was associated with significantly lower systolic BP at 6 months among hypertensive adults, real-world results from Europe show.

“We don’t know what they did to lower their blood pressure,” said Jay Shah, MD, Division of Cardiology, Mayo Clinic Arizona in Phoenix. | Medscape Cardiology.

“The idea is that because they were exposed to their data on an ongoing basis, that may have prompted them to do something that led to an improvement in their blood pressure, whether it’s exercising more, going to the doctor or changing their medication.” said Shah, who is also Aktiia’s medical director.

Shah presented the study at the American Heart Association (AHA) Hypertension Scientific Sessions 2022 in San Diego.

Empowerment data

The study used the Aktiia 24/7 blood pressure monitor; Atkiia funded the trial. The monitor passively and continuously monitors BP values ​​from photoplethysmography signals collected through optical sensors on the wrist.

After initial individualized calibration using a cuff-based reference, BP measurements are displayed on a smartphone app, allowing users to constantly monitor their own BP over extended periods of time.

Aktiia received the 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 actual Aktiia users in Europe (age 57 ± 11 years; 14% women) who wore the monitor consistently for 6 months.

In total, they had data on 375 (±287) app interactions, 3646 (±1417) uncuffed reads per user, and 9 (±7) cuffed reads per user.

The SBP averages of the traditional cuff were calculated monthly and compared with the average SBP of the first month. A t-test analysis was used to detect the difference in SBP between the first and subsequent months.

Based on mean SBP calculated over 6 months, 136 participants were hypertensive (SBP > 140 mm Hg) and the remainder 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 < 0.02), after 3 months of continuous BP monitoring without a cuff, which was maintained for 6 months.

Among users with SBP < 140 mm Hg, mean SBP was unchanged.

“The magnitude of the improvement may seem modest, but even a 5 mm Hg reduction in systolic BP correlates with a 10% decrease in cardiovascular riskShah said. | Medscape Cardiology.

He noted that “one of the main obstacles is that people may not realize 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 your continuous blood pressure image really allows them to do something to make changes and be aware, and be a more active participant in their health,” Shah said.

He said a good analogy is diabetes management, which has gone from glucose monitoring with a single finger prick to continuous glucose monitoring that provides a complete picture of glucose levels 24 hours a day, 7 days a week.

transformative technology

Offering a perspective on the study, Harlan Krumholz, MD, SM, of Yale New Haven Hospital and Yale School of Medicine, New Haven, Conn., said having an accurate, affordable, and discreet cuffless continuous blood pressure monitor “would transform “Blood pressure control.

“This could unlock an era of precise BP monitoring by empowering patients to see and act on their numbers,” Krumholz said. | Medscape Cardiology.

“We need data to build trust in devices, and then research to better harness information flows, and strategies to optimize their use in practice,” Krumholz added.

“Like any new innovation, we need to mitigate risks and control unintended adverse consequences, but I’m optimistic about the future of cuffless continuous blood pressure monitors,” Krumholz said.

Krumholz said, “I applaud Aktiia for conducting studies evaluating the effect of the information they produce on BP over time. We need to know that new approaches not only generate valid information, but can improve health.”

Ready for prime time?

In June, as reported by | Medscape CardiologyThe European Society of Hypertension released a statement noting that cuffless BP measurement is a promising and rapidly growing field with considerable potential to improve awareness, management and control of hypertension, but because the accuracy of These new devices have not yet been validated, they are not yet suitable for clinical use.

Stephen Juraschek, MD, PhD, director of research, Healthcare Associates Hypertension Center of Excellence, Beth Israel Deaconess Medical Center, Boston, also provided insight, saying “there is a lot of interest in cuffless BP monitors because of their ease of measurement, comfort, and the ability to obtain BP measurements in multiple settings and environments, and this study showed that monitoring improved BP over time.”

“It is believed that increased awareness and feedback may promote healthier behaviors aimed at lowering BP. However, this result should not be confused with the accuracy of these monitors,” Juraschek said.

He also noted that there is still no validation protocol formally approved by the Association for the Advancement of Medical Instrumentation.

“While the FDA does approve a number of cuffless devices through its 510k (ie, device equivalency demonstration) mechanism, there is no formal seal of approval or certification that the measurements are accurate,” Juraschek said. | Medscape Cardiology.

In their opinion, “further work is needed to understand the validity of these devices. For now, validated home cuff-based devices are recommended for home BP measurement, while more work is done to determine the accuracy of these.” sleeveless 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 heal PA 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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