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Some Reassurance That a Cuffless BP Sensor Works No matter Body Fat, Skin Color

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SAN DIEGO — For a given individual, blood pressure (BP) readings were largely the identical coming from a cuffless photoplethysmography (PPG)-based monitor or a conventional cuff-based device — whatever the person’s sex, BMI, or skin color, a study showed.

Calibrated to a cuffed device and used for cuffless wrist- and chest-based BP measurement, the Biobeats sensor consistently had BP measurements correlate strongly with parallel readings from the cuffed device. This was observed in men and girls, across a spread of BMI, and in lighter and darker skin tones alike, in response to Arik Eisenkraft, MD, of Biobeat Technologies of Petah Tikva, Israel and the Hebrew University in Jerusalem.

Eisenkraft noted that almost 80% of cuffless measurements differed by lower than 5 mmHg from control readings; almost none of measurements went beyond a 10-mmHg difference. This adds evidence of the highly similar results produced by the 2 BP measurement methods, he said.

The study was prompted by concerns that PPG-based devices give inaccurate readings and will be led astray by subcutaneous fat and darker skin color. “FDA asked us to supply or conduct a comparison study to see whether measurements are in high correlation with cuff-based devices in various populations,” he stated in a presentation on the Hypertension meeting hosted by the American Heart Association.

Biobeat’s wearable distant patient monitoring device has received FDA clearance for the measurement of respiratory rate, body temperature, BP, blood oxygen saturation, and pulse rate.

Through the session Q&A, Michael Lee, MD, of Kaiser Permanente Southern California in Rancho Cucamonga, asked in regards to the impact of an individual’s position — lying down or standing up — on the Biobeat’s performance. He cited a study, also presented at this Hypertension meeting, that had found cuffless BP measurements to correlate well with standard ambulatory monitoring during daytime but not nighttime.

Lee commented that cuffless technology has quite a lot of potential for use as a 24-hour BP monitor and if it really works standing or sitting, “that might be ideal.”

Eisenkraft reassured that “this will not be a problem” for this particular device but cautioned that there are several cuffless BP monitor firms with different sensors that he cannot comment on.

Speaking of the competition, he said “we share quite a lot of frustration mainly because there aren’t any clear [regulatory] guidelines when cuffless BP devices … We’ve quite a lot of data and we feel the medical community’s still not there the tremendous capabilities of such technologies.”

Discussion co-moderator Paul Muntner, PhD, of the University of Alabama at Birmingham, nevertheless identified the priority that changing cuffless BP readings over time could also be tied more to their dwindling calibration value fairly than true BP change.

In keeping with Eisenkraft, the Biobeat sensor currently stands for 3 months of accurate measurements between recalibrations, but there could also be upcoming data to indicate that calibration can occur less steadily. “The long-term aim will not be to make use of calibration in any respect,” he said.

For the study, the authors relied on Israel’s infrastructure of widespread BP measurement stations. Investigators had greater than 1,500 ambulatory individuals undergo cuff-based and cuffless BP measurement at the identical time. Volunteers underwent the method a couple of times a month.

Participants averaged age 35, and 42.9% were men. Mean BMI was 24. By skin tone, the cohort was divided between the 60% categorized as Fitzpatrick 1-3 (very reasonable to medium) and the remaining 40% Fitzpatrick 4-6 (olive to black).

Attendee Gbenga Ogedegbe, MD, of NYU Langone Health in Recent York City, pressed the problem of skin color. He identified the potential spectrum bias arising from an insufficiently wide selection of skin color categories within the study.

“We’re working intensively with countries equivalent to South Africa, French Congo, and other African countries. This offers us quite a lot of worthwhile data looking specifically at darker tones, which are frequently considered more difficult for this technology,” Eisenkraft noted.

Disclosures

Eisenkraft is vice chairman clinical and regulation at Biobeat Technologies.

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