Local pulse wave velocity (PWV) is evolving as one of the important determinants of arterial hemodynamics, localized vessel stiffening associated with several pathologies, and a host of other cardiovascular events. Although PWV was introduced over a century ago, only in recent decades, due to various technological advancements, has emphasis been directed toward its measurement from a single arterial section or from piecewise segments of a target arterial section. This emerging worldwide trend in the exploration of instrumental solutions for local PWV measurement has produced several invasive and noninvasive methods. As of yet, however, a univocal opinion on the ideal measurement method has not emerged. Neither have there been extensive comparative studies on the accuracy of the available methods. Recognizing this reality, makes apparent the need to establish guideline-recommended standards for the measurement methods and reference values, without which clinical application cannot be pursued. This paper enumerates all major local PWV measurement methods while pinpointing their salient methodological considerations and emphasizing the necessity of global standardization. Further, a summary of the advancements in measuring modalities and clinical applications is provided. Additionally, a detailed discussion on the minimally explored concept of incremental local PWV is presented along with suggestions of future research questions.

Local Pulse Wave Velocity: Theory, Methods, Advancements, and Clinical Applications

Objective: We propose a calibration-free method and system for cuffless blood pressure (BP) measurement from superficial arteries. A prototype device with bi-modal probe arrangement was designed and developed to estimate carotid BP – an indicator of central aortic pressure. Methods: Mathematical models relating BP parameters of an arterial segment to its dimensions and local pulse wave velocity (PWV) are introduced. A bi-modal probe utilizing ultrasound and photoplethysmograph sensors was developed and used to measure diameter values and local PWV from the carotid artery. Carotid BP was estimated using the measured physiological parameters without any subject- or population-specific calibration procedures. The proposed cuffless BP estimation method and system were tested for accuracy, usability, and for potential utility in hypertension screening, on a total of 83 subjects. Results: The prototype device demonstrated its capability of detecting beat-by-beat arterial dimensions and local PWV simultaneously. Carotid diastolic BP (DBP) and systolic BP (SBP) were estimated over multiple cardiac cycles in real-time. The absolute error in carotid DBP was Conclusion: The feasibility of calibration-free, cuffless BP measurement at an arterial site of interest was demonstrated with a level of acceptable accuracy. The study also demonstrated the potential utility of the proposed method and system in hypertension screening and local evaluation of arterial stiffness indices. Significance: Novel approach for calibration-free cuffless BP estimation; a potential tool for local BP measurement and hypertension screening.

Bi-Modal Arterial Compliance Probe for Calibration-Free Cuffless Blood Pressure Estimation

Despite much effort, synthetic small diameter vascular grafts still face limited success due to vascular wall thickening known as intimal hyperplasia (IH). Compliance mismatch between graft and native vessels has been proposed to be one of a key mechanical factors of synthetic vascular grafts that could contribute to the formation of IH. While many methods have been developed to determine compliance both in vivo and in vitro, the effects of compliance mismatch still remain uncertain. This review aims to explain the biomechanical factors that are responsible for the formation and development of IH and their relationship with compliance mismatch. Furthermore, this review will address the current methods used to measure compliance both in vitro and in vivo. Lastly, current limitations in understanding the connection between the compliance of vascular grafts and the role it plays in the development and progression of IH will be discussed.

Current understanding of intimal hyperplasia and effect of compliance in synthetic small diameter vascular grafts.

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.

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

Objective: We investigate the field feasibility of carotid stiffness measurement using ARTSENS® Touch and report the first community-level data from India. Method: In an analytical cross-sectional survey among 1074 adults, we measured specific stiffness index ( $\beta $ ), pressure-strain elastic modulus ( $\text{E}_{\text {p}}$ ), arterial compliance (AC), and one-point pulse wave velocity (PWV $_{\beta }$ ) from the left common carotid artery. Data for established risk factors (waist circumference, blood pressure, plasma glucose, triglycerides, and HDL-C) were also collected. The association of carotid stiffness with age, gender, hypertension/diabetes, smoking, and clustering of risk factors was studied. Results: Measurements were repeatable with a relative difference (RD) between consecutive readings of $\sim 80$ % of arterial diameter values. The average RDs for $\beta $ , $\text{E}_{\text {p}}$ , AC, and PWV $_{\beta }$ , were 20.51%, 22.31%, 25.10%, and 14.13%, respectively. Typical range for stiffness indices among females and males were $\beta $ : 8.12 ± 3.59 vs 6.51 ± 2.78, $\text{E}_{\text {p}}$ : 113.24 ± 56.12 kPa vs 92.33 ± 40.65 kPa, PWV $_{\beta }$ : 6.32 ± 1.38 ms−1 vs 5.81 ± 1.16 ms−1, and AC: 0.54 ± 0.36 mm2 kPa−1 vs 0.72 ± 0.38 mm2 kPa−1. Mean $\beta $ , $\text{E}_{\text {p}}$ , and PWV $_{\beta }$ increased (and mean AC decreased) across decades of age; the trend persisted even after excluding hypertensives and subjects with diabetes. The odds ratio of presence of multiple risk factors for $\text{E}_{\text {p}} \ge93.71$ kPa and/or PWV $_{\beta } \ge6.56$ ms−1 was ≥ 2.12 or above in males. In females, it was just above 2.00 for $\text{E}_{\text {p}} \ge91.21$ kPa and/or PWV $_{\beta } \ge5.10$ ms−1 and increased to ≥ 3.33 for $\text{E}_{\text {p}} \ge143.50$ kPa and ≥ 3.25 for PWV $_{\beta } \ge7.31$ ms−1. Conclusion: The study demonstrated the feasibility of carotid stiffness measurement in a community setting. A positive association between the risk factors and carotid artery stiffness provides evidence for the device’s use in resource-constrained settings. Clinical Impact: The device paves the way for epidemiological and clinical studies that are essential for establishing population-level nomograms for wide-spread use of carotid stiffness in clinical practice and field screening of ‘at-risk’ subjects.

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Assessment of Carotid Arterial Stiffness in Community Settings With ARTSENS

Vascular stiffness is an indicator of cardiovascular health, with carotid artery stiffness having established correlation to coronary heart disease and utility in cardiovascular diagnosis and screening. State of art equipment for stiffness evaluation are expensive, require expertise to operate and not amenable for field deployment. In this context, we developed ARTerial Stiffness Evaluation for Noninvasive Screening (ARTSENS), a device for image free, noninvasive, automated evaluation of vascular stiffness amenable for field use. ARTSENS has a frugal hardware design, utilizing a single ultrasound transducer to interrogate the carotid artery, integrated with robust algorithms that extract arterial dimensions and compute clinically accepted measures of arterial stiffness. The ability of ARTSENS to measure vascular stiffness in vivo was validated by performing measurements on 125 subjects. The accuracy of results was verified with the state-of-the-art ultrasound imaging-based echo-tracking system. The relation between arterial stiffness measurements performed in sitting posture for ARTSENS measurement and sitting/supine postures for imaging system was also investigated to examine feasibility of performing ARTSENS measurements in the sitting posture for field deployment. This paper verified the feasibility of the novel ARTSENS device in performing accurate in vivo measurements of arterial stiffness. As a portable device that performs automated measurement of carotid artery stiffness with minimal operator input, ARTSENS has strong potential for use in large-scale screening.

Technical Validation of ARTSENS–An Image Free Device for Evaluation of Vascular Stiffness

Arterial stiffness is recognized as an independent risk factor for cardiovascular events and has potential in vascular screening. We have developed ‘ARTSENS®’, an image free system for evaluation of vascular stiffness. Here, we present ARTSENSTouch, a portable device for evaluation of carotid artery stiffness in field settings. A technical validation of the device in comparison with reference ultrasound imaging system is presented. The validation study emulated constraints faced in evaluation of stiffness in field, such as measurement in sitting posture, use of brachial blood pressure for computations, limited time available for testing and lack of electrical power supply for instrument. The usability of the device and its accuracy, with respect to the reference ultrasound imaging system, was verified by conducting in-vivo measurements on 30 subjects. Stiffness measurements made using ARTSENS in sitting posture showed strong correlation with those obtained from the imaging system in supine posture. The repeatability of ARTSENS measurements was also found to be satisfactory.

Arya Sree Thrivikraman

Papers

Technical Validation of ARTSENS–An Image Free Device for Evaluation of Vascular Stiffness

ARTSENSTouch - A portable device for evaluation of carotid artery stiffness