Need for early diagnosis

Cardiovascular disease in the leading cause of death both in men and women globally. Recent statistics from the World Health Organization indicate that such cardiovascular diseases (CVDs) are the world’s largest killers, resulting in 17.1 million deaths a year. Estimates indicate that by 2030, almost 23.6 million people will die from CVDs, mainly from heart disease and stroke. The earliest risk indicator of a possible CVD is the presence of atherosclerosis. Early detection of atherosclerosis and adequate treatment and lifestyle changes would enable the patient to prevent the onset of a CVD. This would result in considerable reduction in financial burden associated with advanced stages of CVD both at the individual level and health care systems.

Best clinical marker for early detection

Owing to its anatomical position and its relatively large diameter, the Common Carotid Artery (CCA) is the preferred artery for routine clinical examination to detect cardiovascular events and risks. Carotid IMT (CIMT) is the well established marker for early staging of the Atherosclerotic disease and it is also associated with the development of the cardiovascular events and cardiovascular outcomes. Atherosclerotic Wall Region (AWR) is the region between LI and MA borders in the ultrasound image for the blood vessel. In the longitudinal ultrasound image, the CCA (lumen) appears as a region of low intensity between two layers of high intensity, namely, the Near Adventitia (ADN) and Far Adventitia (ADF). The Intima-Media Thickness (IMT) of the CCA is the most commonly used measure for atherosclerosis monitoring, and is defined as the distance between the interfaces.

Stenosis is the narrowing of the artery due to the plaque build-up in the arterial walls. The plaque build-up can be in the near or far walls of the carotid artery. The Lumen Diameter(LD) defined as the distance between the lumen borders of the Common Carotid Artery (CCA), is an indication of stenosis build-up if measured accurately. Stenosis measurement is the deviation of the lumen diameter thickness from its normal course. The severity of the stenosis indicates the narrowing of the artery or blockage due to plaque build-up and used as stenosis severity index.

Current limitations

The examination of carotid artery is mostly carried out using non-invasive ultrasound, which is a cost-effective and relatively fast imaging technique that does not use ionising radiation. However, ultrasound technique is operator dependent, and hence, the interpretation is subjective. Manual Atherosclerotic Wall Region (AWR) and measurement of IMT/LD from B-mode images is time consuming, subjective, and difficult.

Why AtheroEdge™ 2.0 ?

Our FDA approval pending AtheroEdge™ 2.0 software overrides the above limitations and generates fully automated measurements. AtheroEdge™ 2.0 software estimates Lumen-Intima (LI) and Media-Adventitia (MA) borders and automatically measures the Intima-Media Thickness (IMT) of the longitudinal carotid artery images obtained from ultrasound systems. AtheroEdge™ 2.0 is also used for measuring the Lumen Diameter(LD) and Stenosis Severity Index (SSI) given the common carotid or internal carotid ultrasound scan of the patient.

AtheroEdge™ 2.0 software package runs on a stand-alone computer running a Microsoft Windows™ XP, Microsoft Windows™ 7.0 or Microsoft Windows™ 8.0 Operating System. There is no dedicated medical equipment required for operation of this software. The carotid ultrasound images are digitally transferred to the computer system running AtheroEdge™ 2.0 application. AtheroEdge™ 2.0 can accept the ultrasound scan for the left or the right carotid artery.

AtheroEdge™ 2.0 software provides a means of opening and displaying images in DICOM, ISO joint Photographic Experts Group (JPEG) Image Compression Standard, Microsoft Windows’s BMP formats, CompuServe’s Graphics Interchange Format (GIF) and Portable Network Graphics (PNG) formats. It can preprocess low resolution images before analyzing the image for measurement. AtheroEdge™ 2.0 uses proprietary techniques and algorithms to automatically measure the Intima-Media Thickness (IMT) or the Lumen Diameter (LD) and its variability of the distal (far) wall of the carotid artery in ultrasound image. AtheroEdge™ 2.0 software provides a means for creating a region of interest on the distal (far) wall image and display by the software. AtheroEdge™ 2.0 software provides a means of analyzing the content of the image data contained within the region of interest (ROI) and compute the IMT/LD and its variability.

AtheroEdge™ 2.0 software generates automated computer-based IMT or LD measurement with higher accuracy and reproducibility even for low contrast, low resolution longitudinal B-Mode images of the carotid artery. It then generates a report indicating the patient’s IMT or LD/SSI measurement and its variability values. This information is used adjunctively with other medical data by a physician to help assess the cardiovascular health of a patient. AtheroEdge™ 2.0 is also capable of storing patient measurement values in the database management system along with the images for future reference.