Key result
The HeartBeat smartphone algorithm and pulse oximeter did not meet ESH-IP2 accuracy standards for calculating systolic or diastolic blood pressure compared to manual measurement.
Why the study?
To determine whether the HeartBeat algorithm calculates blood pressure as accurately as required by the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) for validating blood pressure measuring devices.
Does the HeartBeat algorithm accurately calculate blood pressure from photoplethysmography compared to manual measurement in a general adult population?
Does the HeartBeat algorithm accurately calculate blood pressure from photoplethysmography compared to manual measurement in a general adult population?
The tested version of the HeartBeat algorithm using photoplethysmography via smartphone and pulse oximeter is not sufficiently accurate for remote blood pressure monitoring in adults.
HeartBeat smartphone BP estimates should not guide care; leaves open need for PPG algorithm validation to ESH-IP2 standards.
BACKGROUND Outside of a clinical setting, oscillometric devices make remote monitoring of blood pressure and virtual care more convenient and feasible. HeartBeat Technologies Ltd developed a novel approach to measuring blood pressure remotely after an initial blood pressure reading by a nurse using the conventional measurement method. Using a finger pulse oximeter, a photoplethysmogram wave is transmitted by Bluetooth to a smartphone or tablet. A smartphone app (MediBeat) transmits the photoplethysmogram to a server for analysis by a proprietary algorithm—the person’s current blood pressure is sent back to the smartphone and to the individual’s health care provider. OBJECTIVE This study sought to determine whether the HeartBeat algorithm calculates blood pressure as accurately as required by the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) for validation of blood pressure measuring devices. METHODS ESH-IP2 requirements, modified to conform to a more recent international consensus statement, were followed. The ESH-IP2 establishes strict guidelines for the conduct and reporting of any validation of any device to measure blood pressure, including using the standard manual blood pressure instrument as a comparator and specific required accuracy levels for low, medium, and high ranges of blood pressure readings. The consensus statement requires a greater number of study participants for each of the blood pressure ranges. The validation of the accuracy of the algorithm was conducted with a Contec CMS50EW pulse oximeter and a Samsung Galaxy XCover 4 smartphone. RESULTS The differences between the HeartBeat-calculated and the manually measured blood pressures of 62 study participants did not meet the ESH-IP2 standards for accuracy for either systolic or diastolic blood pressure measurements. There was no discernible pattern in the inaccuracies of the HeartBeat-calculated measurements. CONCLUSIONS The October 4, 2019 version of the HeartBeat algorithm, implemented in combination with the MediBeat app, a pulse oximeter, and an Android smartphone, was not sufficiently accurate for use in a general adult population. CLINICALTRIAL ClinicalTrials.gov NCT04082819; http://clinicaltrials.gov/ct2/show/NCT04082819
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Holyoke et al. (2020) studied Blood pressure (n=62). HeartBeat algorithm with MediBeat app and pulse oximeter vs. Standard manual blood pressure instrument was evaluated on Accuracy of blood pressure calculation according to ESH-IP2 standards. The HeartBeat smartphone algorithm and pulse oximeter did not meet ESH-IP2 accuracy standards for calculating systolic or diastolic blood pressure compared to manual measurement.
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