Validation of ARTSENS Plus in Comparison to SphygmoCor XCEL for Assessing Arterial Stiffness During Pregnancy: A Cross-sectional Study

Abstract Background Arterial stiffness independently predicts cardiovascular mortality and morbidity. It is shown to be increased in vascular mediated conditions, such as preeclampsia and foetal growth restriction. ARTSENS Plus device assesses arterial stiffness and is validated in older populations. The study aimed to validate its use for measuring arterial stiffness in pregnant women by comparing it with SphygmoCor XCEL as a reference standard. Methods This cross-sectional study was conducted in two centres in the south-eastern region of India, recruiting 147 pregnant women. Arterial stiffness was assessed by the carotid–femoral pulse wave velocity (cfPWV) using both devices and validated according to the ‘2024 recommendations for validation of non-invasive arterial pulse wave velocity measurement devices.’ Bland–Altman plot and coefficient of variation of the test–retest reproducibility were calculated. Results The mean age of the included women was 28 ± 4 years, and their mean gestational age was 24.6 ± 9.5 weeks. The mean difference in cfPWV values obtained from SphygmoCor XCEL and ARTSENS Plus was 0.16 ± 0.54 m/s ( p = 0.12) with a measurement error of 0.85 m/s, indicating good accuracy of the ARTSENS plus device in assessing arterial stiffness. Both devices demonstrated good intra-observer reproducibility, with coefficients of variation of 2.53% for ARTSENS Plus and 3.48% for SphygmoCor XCEL. Conclusions ARTSENS Plus assesses arterial stiffness with good accuracy and intra-observer reproducibility when validated amongst pregnant women.