ARTSENS Pen-portable easy-to-use device for carotid stiffness measurement: technology validation and clinical-utility assessment.

Objective: The conventional medical imaging modalities used for arterial stiffness measurement are non-scalable and unviable for field-level vascular screening. The need for an affordable, easy-to-operate automated non-invasive technologies remains unmet. To address this need, we present a portable image-free ultrasound device-ARTSENS Pen, that uses a single-element ultrasound transducer for carotid stiffness evaluation.

Approach: The performance of the device was clinically validated on a cohort of 523 subjects. A clinical-grade B-mode ultrasound imaging system (ALOKA eTracking) was used as the reference. Carotid stiffness measurements were taken using the ARTSENS Pen in sitting posture emulating field scenarios.

Main Results: A statistically significant correlation (r > 0.80, p < 0.0001) with a non-significant bias was observed between the measurements obtained from the two devices. The ARTSENS Pen device could perform highly repeatable measurements (with variation smaller than 10%) on a relatively larger percentage of the population when compared to the ALOKA system. The study results also revealed the sensitivity of ARTSENS Pen to detect changes in arterial stiffness with age.

Significance: The easy-to-use technology and the automated algorithms of the ARTSENS Pen make it suitable for cardiovascular risk assessment in resource-constrained settings.