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

Abstract

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-tooperate 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 resourceconstrained settings.

Long-term cardiovascular health status and physical functioning of nonhospitalized patients with COVID-19 compared with non-COVID-19 controls

“…Arterial stiffness was assessed by noninvasive, image-free ultrasound technology with the ARTSENS Plus (Healthcare Technology Innovation Center, Indian Institute of Technology Madras, Chennai, India) ( 29 – 32 ). Simultaneous recording of carotid artery distensibility and cuff-based femoral artery blood pressure facilitated assessment of carotid-femoral pulse wave velocity (cf-PWV; m/s), a parameter of central stiffness ( 33 ).…”

Single M-Line Is as Reliable as Multiple M-Line Ultrasound for Carotid Artery Screening

“…The cost of WTS, in combination with the required extensive operator expertise, hampers the large-scale application of arterial properties for screening purposes. Although single M-line-based scanners are not a technical novelty (Palombo et al, 2012 ), their affordability, user-friendliness, and accessibility form a basis for the wider application of arterial property screening in resource-limited settings (Joseph et al, 2020a ). However, because single M-line-based scanners are image-free, they miss image-based features present in multiple M-line-based scanners such as plaque detection and characterization.…”

“…However, to minimize operator dependency, single M-line tools visualize the RF signal together with real-time tracking of the arterial wall. Moreover, they also provide a signal quality score to ensure that the echos are coming from the carotid walls and that the probe is perpendicular to the walls (Joseph et al, 2020a ). These together act as a feedback to guide the operator to orient the probe and reduce operator dependency induced by the lack of image feedback.…”

“…Since resolution largely influences the validity and reproducibility of the estimates obtained using a scanner, it should be taken into account when considering a single M-line device for screening. There exist single M-line tools with temporal and spatial resolution comparable to that of multiple M-line tools (Joseph et al, 2020a ).…”

“…Both types of scanners, therefore, do not meet the pressing need for a screening tool in low-resource areas. Devices based on a single M-line (Joseph et al, 2020a ) are affordable and accessible tools that are promising for diagnosis and screening in LMI countries.…”