ARTSENS (ARTerial Stiffness Evaluation for Non invasive Screening)

Need: To overcome current barriers of expensive technology and high-end technical expertise

Stiffness of blood vessels has been established to be a very strong marker of cardiovascular problems and cardiac aging. Evaluation of arterial stiffness requires accurate measurement of changes in arterial dimensions and blood pressure. State of the art methods use specialised ultrasound imaging equipment to perform this measurement. The requirement of expensive technology and extensive technical expertise to use that technology, limits wide spread use of image-based arterial stiffness measurement. There is a need for an affordable, easy to use technology that can be deployed widely with minimal training.

Innovation: Intelligent, image-free device for vascular stiffness evaluation

HTIC has developed ARTerial Stiffness Evaluation for Non-invasive Screening (ARTSENS). It is an image-free technology for non-invasively measuring arterial stiffness in an automated manner. ARTSENS uses custom designed ultrasound probe integrated with proprietary intelligent signal processing to identify arterial anatomy, capture vessel wall dynamics and calculate clinically accepted measures of stiffness. Once the probe is placed over the neck, the device directly yields the stiffness measurement within 30 seconds. A hand-held cardiovascular screening device based on ARTSENS technology is currently under development.

Impact: Successful technology validation vis-à-vis sophisticated imaging systems

A pilot study conducted in collaboration with MediScan Systems, Chennai on nearly 100 subjects validated the in-vivo measurements made using ARTSENS against a conventional ultrasound imaging system. ARTSENS device was used in a vascular screening camp conducted by Thambiran Heart and Vascular Institute, Chennai to measure arterial stiffness of more than 50 subjects within a period of about 4 hours. These pilot studies demonstrated ability of ARTSENS to measure arterial stiffness under in-vivo settings. The intelligence embedded in the technology allows personnel to use the device with minimal training. An extensive clinical study of ARTSENS is currently underway at Sri Ramachandra University, Chennai.

Verification & Validation

ARTSENS technology was validated both in laboratory environment and clinical settings. Experiments with simulation platforms and artery phantoms demonstrated that ARTSENS could measure artery diameter and distension with error less than 10 % and track wall motion with precision of 6um. Preliminary field validation studies in clinical settings have so far been performed in 3 clinical institutes, on more than 600 subjects to date.

Verification Study Phase 1 – in collaboration with MediScan Systems, Chennai

This study compared the arterial stiffness measurements performed using ARTSENS with those taken using a state of art imaging system (Aloka Prosound α10 with eTracking) to evaluate the measurement accuracy of ARTSENS. In-vivo measurements were performed on 106 subjects in this study. The results from this study showed strong correlations between ARTSENS measurements and those taken using the imaging system.

Verification Study Phase 2 – in collaboration with Thambiran Heart and Vascular Care Institute, Chennai

This study was conducted following improvements made in the hardware and software of ARTSENS, to further validate the ability of the technology to accurately measure arterial stiffness in comparison with state of art imaging systems. In addition to arterial stiffness measurements, anthropometric data and biochemistry parameters were collected from 125 subjects. Strong correlations were observed between ARTSENS measurements and those made by the Aloka imaging system in this study.

Usability study in medical camp setting

To investigate the ability of ARTSENS to perform quick measurements in a screening scenario, the ARTSENS prototype was deployed in a Vascular Screening Camp. ARTSENS was used to perform stiffness evaluation on more than 50 subjects within the 4 hour period of the camp.

Large scale clinical study

An extensive clinical study of the ARTSENS device, to compare arterial stiffness estimates of ARTSENS with conventional measures and other cardiovascular risk factors, is currently underway at Sri Ramachandra University, Chennai. ARTSENS measurements were compared with Pulse Wave Velocity, an established marker of vascular stiffness. Increasing arterial stiffness with age was indicated by increasing pulse wave velocity and stiffness readings of ARTSENS. Results from nearly 400 subjects indicate that ARTSENS can detect increased arterial stiffness associated with presence of risk factors such as low HDL, diabetes etc demonstrating the strong potential of ARTSENS technology in screening and early detection.

Field validation study

An extensive field study of ARTSENS, to investigate prevalence of vascular risk factors, and correlation between arterial stiffness and traditional risk factors was initiated, in collaboration with National Institute of Epidemiology, Chennai. The ARTSENS Touch prototype was used in this study. Arterial stiffness measurements were performed on nearly 1000 subjects. The study is currently in progress.