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. 2023 Jan 16;4(1):9–20. doi: 10.1016/j.cvdhj.2023.01.001

Table 1.

Limitations applying traditional validation approaches to cuffless devices

Limitation Details
No direct BP measurement
  • Cuffless devices estimate BP as a function of derived variables that rely on multiple sensors, proprietary algorithms, and regular calibration with cuff-based devices

  • In contrast, cuff-based devices make sphygmomanometer-based direct measurements in millimeters of mercury (mm Hg)


No ideal referent standard
  • Intra-arterial lines are not appropriate for ambulatory settings and physical activity

  • Office devices are only validated in resting states

  • ABPM’s reliance on oscillometry makes ABPM an indirect measure of SBP and DBP


Static-state assumptions violated
  • Calibration is performed in the seated, rested position, but the device is used in states of physical activity

  • BP estimates are subject to drift with time


“Zero out” bias phenomenon
  • Since postcalibration measurements vary around the calibrated, resting value, the mean of beat-to-beat measures may have a central tendency toward the calibrated, resting value

  • In beat-to-beat measurements, pseudo-precision occurs owing to repetition and the large number of measurements


Applicability to heterogenous populations
  • Radial artery may not be easily accessible in patients with obesity, large wrist circumference, or peripheral artery disease

  • Assumptions about transduction of PTT and PAT may not be generalizable to patients with obesity, high density of chest hair, or large breasts

  • The impact of skin pigmentation on device performance remains unclear


Reliance on heart rate
  • Unlike oscillometric devices, which measure MAP and extrapolate SBP and DBP, cuffless devices rely on HR to inform estimation in change of BP

  • Pulse-BP dissociation occurs in patients who are taking medications (eg, beta-blockers) or who have arrhythmias (eg, atrial fibrillation), and in healthy individuals during sleep

ABPM = ambulatory blood pressure monitoring; BP = blood pressure; DBP = diastolic blood pressure; HR = heart rate; MAP = mean arterial pressure; PAT = pulse arrival time; PTT = pulse transit time; SBP = systolic blood pressure.