FAQ on AtheroEdge™

AtheroEdge™ software is called automated system because it computes the IMT without user interaction. Currently, the sonographer measures the IMT using manual methods by selecting few set of points on the LI interface and MA interfaces and measures the distance between them. This process is completely manual, labor intensive, user dependent resulting in inconsistent results and introducing bias. AtheroEdge™ system computes the IMT (minimum value, maximum value and average value) automatically displaying it on the screen and stores that information in the database management system (DBMS). Thus, there is no user involved in computing the IMT values. The user is not required to put the region of interest manually in this technique. Further, AtheroEdge™ system computes the mean IMT value by computing points along the carotid artery from the edge of the blub and proximal to the blub along the carotid artery in the ultrasound image.

Stenosis is the narrowing of the artery due to the plaque build-up 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. Thus, Stenosis Severity Index (SSI) is an indication of how thick is the plaque deposits in the artery and lumen diameter can be used for measuring the stenosis severity index.

• Fully Automated system: There are several existing products who compute the IMT or LD values. There are two ways to measure IMT/LD in current methodology: (i) first, by selecting a few set of points on the LI interface and MA interfaces or the lumen borders along the carotid artery, and then manually computing the distance between them. This is purely manual method. (ii) Second, by manually placing a rectangular window or region of interest (ROI) in the far wall of the carotid artery and then computing the LI and MA interfaces or the lumen borders (as points) in this ROI. Finally measuring the distance between these LI and MA interfaces or the lumen borders given these LI and MA points. This is called semi-automated method. These methods are either fully manual methods or semi-automated methods. Due to the dependence on the user inputs, these methods are subjective, leads to inconsistent results and suffer from both bias and inter-and-intra observer variability. Further, these methods if done for a cohort of studies can introduce a progressively increasing bias leading to wrong diagnosis for clinical trials. AtheroEdge™ 2.0 was developed to address the above shortcomings in current technologies. Compared to the current methods, AtheroEdge™ 2.0 is fully automated saving the doctor’s work flow time, and improving the neurological and cardiological healthcare quality by removing subjective bias and is able to run the cohort of images automatically.
• Slope of the Carotid Artery: Regardless of the slope of the carotid artery in the ultrasound image, the AtheroEdge™ 2.0 automated system finds the LI/MA interfaces all along the carotid artery and follows the gradient in lumen-intima and media-adventitia regions. This means AtheroEdge™ 2.0 can estimate the LI/MA interfaces or the lumen borders for up-slope, down-slope, convex shape, concave shape, straight arterial representations automatically followed by IMT/IMTV or LD/SSI/LDVar calculations. This can be seen in our website: www.atheropoint.com. Please follow the link: AtheroEdge, 2.0 and then Highlights.
• Variability Computation: AtheroEdge™ 2.0 computes IMTV or LDVar/SSI values, called the wall variability. This is a very important clinical feature which tells about the extent of plaque deposition penetrating into the lumen region. 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. Thus, stenosis severity index is an indication of how thick is the plaque deposits in the artery and lumen diameter can be used for measuring the stenosis severity index. The wall variability is a biomarker for symptomatic atherosclerosis disease. AtheroPoint™ has proven this feature with latest results published in international peer-reviewed journals. A complete list of journal publications can be found on our website at: www.atheropoint.com/AtheroEdge/2.0/Highlights/IMTV.
• Mitigation and Ability to alter the LI/MA interfaces or lumen borders: While AtheroEdge™ 2.0 is completely automated, it further allows user to override by allowing adjustment of LI/MA interfaces or lumen borders interactively. Here the user can place the ROI of any length and width along the far wall of the carotid artery, and the LI/MA interfaces or lumen borders are estimated automatically. Any deviation in the LI/MA wall interfaces or lumen borders can be manually adjusted by the user in case there is a need. Such mitigation is very helpful for low resolution carotid ultrasound images. Low resolution images do not have harmonic and compound imaging feature, which degrades the quality of carotid ultrasound images.
• Batch Mode Processing: AtheroEdge™ 2.0 allows computing the IMT/LD in a batch mode for clinical trials. In batch mode, AtheroEdge runs on several images (as high has 10,000) images and processes them automatically one-by-one for clinical trial data analysis such as mean and standard deviation computation for a cohort of patients. The batch mode process is also automated.
• Inbuilt Database Management System: AtheroEdge™ 2.0 software is equipped with the database management system which allows the storage of the following information such as: patient information, results of the ultrasound image analysis and clinical reports. These reports can be accessed any time in future. This inbuilt DBMS allows monitoring the IMT/IMTV or LD/LDVar/SSI over a course of time enabling them to update the treatment as per the response.
• Interface with several OEM machines: Currently all IMT or LD semi-automated systems are scanner dependent. There is no universal automated IMT/IMTV or LD/LDVar measurement tool. On the contrary, AtheroEdge™ 2.0 can interface with several carotid ultrasound images from different ultrasound imaging machines of major manufacturers such as: eSaote (Italy), Philips (Netherlands), GE (USA), Siemens (Germany), Toshiba (Japan), Hitachi (Japan), SonoSite (USA).
• Independent of Scanner Type: AtheroEdge™ 2.0 is independent of the type of scanner used for acquiring the carotid ultrasound image. Current IMT tools are dependent upon the resolution of the carotid ultrasound image. AtheroEdge™ 2.0 is a tool which works for high resolution, medium resolution and low resolution carotid ultrasound images, rather generalized carotid ultrasound images. AtheroEdge™ 2.0 has ability to tune to understand the carotid ultrasound image for a specific machine and adjust accordingly to accurately determine the IMT/IMTV or LD/LDVar.
• Review System: AtheroEdge ™ changes the diagnostic measurement system for IMT/IMTV or LD/LDVar measurement mode into a review and display mode. The results are stored in the Database Management system (just like PACS system) and the user can open the stored original images, images showing LI/MA interfaces or lumen borders, IMT/LD values, IMTV/LDVar values and the clinical parameters and doctor’s reports any time in future. Under the review mode, the AtheroEdge™ 2.0 system can be used to study the history of the patient, its analysis over time and make better clinical decisions over the course of time.
• Report Generation System: AtheroEdge™ 2.0 has the ability to print Patient’s report showing the original image, LI/MA interfaces on grayscale image, IMT/IMTV values, LD/LDVar/SSI values and comments from the physicians during the patient’s visit and/or repeat visits of the patient by monitoring the IMT/IMTV or LD/LDVar measurements.
• Screen Printing Capability: AtheroEdge™ 2.0 has the ability to capture the screen information such as LI/MA interfaces on the grayscale images along with the IMT/IMTV or LD/LDVar/SSI values and print them instantaneously for the records if needed.
• Applications: AtheroPoint™ is able to guide the clients on how to use the AtheroEdge™ 2.0 for different applications, such as development of relationship between IMT or LD and different parameters related to disease monitoring:
  • Relationship between obesity and IMT.
  • Relationship between HbA1c and IMT.
  • Relationship between Syntax Score and IMT.
  • Relationship between Diabetic Retinopathy and IMT.
  • Relationship between Coronary Artery Disease and IMT.
  • Relationship between Leukoaraiosis and IMT.

AtheroEdge™ software is an automated IMT measurement system and the user will get the same result if he runs the software on the same image at different times in the automated mode. In the semi-automated mode the user will also get the same result if the region of interest (ROI) box is positioned at the same location proximal to the bulb at different times. For further details please see the citation: “Inter- and Intra-Observer Variability Analysis of Completely Automated cIMT Measurement Software (AtheroEdge™) and its Benchmarking against Commercial Ultrasound Scanner and Expert Readers.” Saba L, Molinari F, Meiburger KM, Acharya UR, Nicolaides A, Suri JS., Computers in Biology and Medicine. 2013 Sep; 43(9) pp. 1261-1272; doi: 10.1016/j.compbiomed.2013.06.012.

AtheroEdge™ has been run on over 10,000 images taken from different OEM machines (so called different databases representing different ethnicity). AtheroEdge™ has shown to be highly accurate system with very high figure of merit (FoM) and this has been presented in several international peer reviewed journal publications.

AtheroEdge™ software has been validated against the human tracings and Computer Tomography (CT) modality. Human tracings are the manual tracings of the LI/MA interfaces in carotid ultrasound images.

It means that AtheroEdge™ software determines LI and MA far wall tracing proximal from the edge of the bulb (bifurcation) up to a maximum of 3 centimeters along the carotid artery. It further depends upon the type of the plaque present. They are normally categorized into light plaque (LP) or heavy plaque (HP). In cases of light or medium plaque images, AtheroEdge™ is most likely going to give the LI/MA interfaces all along the carotid artery.Our patented software automatically recognizes the far wall of the carotid artery in the presence of near and far jugular vein and near and far wall of the carotid artery.

AtheroEdge™ software generates a clinical report automatically when the user has processed the IMT/IMTV measurements. The printable report consists of information about the patient, the anatomical information about the carotid artery, the ultrasound parameter information, the IMT/IMTV measurement values, raw ultrasound and processed ultrasound images and comments by the attending physician. Typically, the clinical report can be 3-7 pages.The report is a record in a PDF format which is stored in the database management system for future reference.

In service model, the medical institution arranges the anonymized ultrasound carotid image data to be sent to AtheroPoint™ either through a CD (computer disk) or via cloud and AtheroPoint™ processes these images and sends back the reports to the institution in a CD or loaded onto the HIPPA compliant secure server. This is a service model.

Before enrolling in AtheroPoint™’s service program, we encourage you to enroll in our “free service program (FSP)”. In “free service program (FSP)”, AtheroPoint™ does not charge the customer for its measurement services and the user can test the software for free upto 25 patient images for evaluation.

Once the vascular lab in a clinic or hospital is satisfied with our performance and they are willing to enroll in our “service program”, they can contact our sales and service representative in their respective area.

The patient image data stored on the Amazon cloud is HIPPA compliant and perfectly safe to transfer image data to Amazon cloud. It is the responsibility of the medical institution to anonymize the patient information presented in the ultrasound image before delivery to AtheroPoint™ for service model. AtheroPoint™ processes the ultrasound images with patient ID number as the key to trace the records for later. The cloud storage cost is integrated into the service pricing model. Please discuss with the distribution and sales representative in your area for further details.

It is entirely the responsibility of the medical institution or the evaluating/enrolled user to make sure that the image data shipped to AtheroPoint™ for processing is delivered securely in entirety. The user is legally obliged to provide a secure and accurate address for AtheroPoint™ to ship them back the image data along with the reports. AtheroPoint™ is not liable to any data loss that may occur either during the delivery to or from AtheroPoint™.

AtheroPoint™ does not warranty any clinical interpretations. All clinical decisions about the patient rest on the evaluating physician or medical unit. Please see our warranty information in our free service agreement. AtheroEdge™ 2.0 is a software tool which helps in IMT/IMTV or LD/LDVar measurements on ultrasound images and our mission is to support vascular labs in estimating the IMT/IMTV or LD/LDVar as accurately as possible.