Validation assessment of a cuff-based central blood pressure device according to Artery Society recommendations

Objective Uscom BP+ is a cuff-based blood pressure (BP) device designed to noninvasively estimate central BP as distinct from conventional brachial BP. This study aimed to assess the accuracy of the Uscom BP+ device compared with invasively measured BP. Methods Automated noninvasive cuff central BP (using the Uscom BP+ device) and invasive central aortic BP were recorded simultaneously in 191 participants (65% male, aged 66 ± 11 years) receiving coronary angiography at three independent research sites in Australia, Poland, and Italy. Validation procedures were undertaken according to the Artery Society recommendations and with a minimally acceptable error (mean ± SD) of ≤5 ± ≤8 mmHg as pass criteria. Results Using the device default calibration technique [brachial cuff systolic blood pressure (SBP) and diastolic blood pressure (DBP)], cuff central SBP underestimated invasive central SBP [mean (SD) difference: –10.2 (11.2) mmHg] and cuff central DBP overestimated invasive central DBP [mean (SD) difference: 9.8 (8.5) mmHg]. When calibrating by brachial cuff mean arterial pressure and DBP, SBP accuracy was improved, but variability remained high [mean (SD) difference: –6.3 (14.4) mmHg, P = 0.004 vs. default calibration, whereas DBP accuracy and variability remained similar [mean (SD) difference: 10.9 (8.5) mmHg, P = 0.19 vs. default calibration]. Conclusion The Uscom BP+ cuff device does not pass the Artery Society accuracy criteria compared with invasively measured central BP.