e-STROKE SUITE is the integrated stroke imaging solution for acute stroke pathways. It includes decision support tools for the analysis of CT, CT Angiography (CTA), CT Perfusion (CTP) and MRI images, via the e-ASPECTS, e-CTA and Olea Sphere modules.
e-ASPECTS is the non-contrast CT processing module in e-STROKE SUITE, which automates and standardizes the assessment of ischemia on acute stroke patient brain CT scans. You can use e-ASPECTS to estimate the volume of ischemia, and compute the clinically validated ASPECTS score, to help optimize patient selection for stroke treatments.
e-CTA is the CTA processing module in e-STROKE SUITE, which automates and standardizes the assessment of collaterals on acute stroke patient brain CTA scans. You can use e-CTA to estimate the status of collaterals and to compute the CTA Collateral Score (CTA-CS). e-CTA will also provide an indication of the acquisition phase of the CTA scan, to help ensure quality control and standardized interpretation.
Olea Sphere® is the CTP and MRI software solution in e-STROKE SUITE, which automates and standardizes the assessment of mismatch and volume on acute stroke patient brain CTP and MRI scans. You can use Olea Sphere® to estimate the volume of ischemia and penumbra, and compute the mismatch ratio, to help optimize patient selection for stroke treatments.
The individual modules, e-ASPECTS, e-CTA, and Olea Sphere®, can be licensed separately or as part of a package. If you only want to use e-STROKE SUITE on noncontrast CT images, for example, then it is only necessary to license the e-ASPECTS module. In all cases, you will have access to the integrated web browser user interface, DICOM results sent automatically to your existing PACS or other radiology systems, and email result notifications.
Existing e-ASPECTS installations will be upgraded to e-STROKE SUITE, with e-ASPECTS as a licensed module, free of charge. It will be possible to enable additional modules, including e-CTA and Olea Sphere®, following the upgrade. Ask your Brainomix contact point, or email email@example.com, for more details.
Yes – e-ASPECTS, e-CTA, and Olea Sphere® are all CE marked class IIa medical devices, intended for use as decision support tools for analysis of acute ischemic stroke patient brain CT, CTA, and CTP/MRI scans, respectively. Olea Sphere® is also FDA cleared and licensed in Australia and Canada.
The assessment of the brain CT scan of an acute ischemic stroke patient is a crucial step towards treatment decisions. Not all stroke physicians are equally confident to interpret CT scans, since early ischemic changes are subtle and may be hard to detect, even if the damage is already present in several ASPECTS regions. e-ASPECTS delivers a rapid, robust and standardized assessment of CT scans of acute ischemic stroke patients on expert level, serving as an expert second opinion for the physician’s interpretation, thereby introducing confidence, consistency and speed into the physician’s clinical decision making.
A multi-center clinical study was carried out by Anglia Ruskin Clinical Trials Unit (Nagel, Sinha, et al., IJ Stroke, 2017), comparing the performance of e-ASPECTS to expert scorers on baseline CT scans. The ground truth was independently set based on what was visible on both the baseline scans and follow-up CT scans together with clinical information. The study showed that on average e-ASPECTS is statistically non-inferior to experts at performing ASPECTS scoring on brain CT scans of acute ischemic stroke patients.
Like a human expert neuroradiologist, the software is not 100% accurate and on occasion, an ischemic region may be missed, or a healthy region may be falsely detected as being ischemic. e-ASPECTS is licensed as a decision support tool to complement the interpretation of the brain CT scans by the physician, and users should interpret the results using their own expertise to decide on an ASPECTS score.
Yes – e-ASPECTS will estimate the volume, in ml, of ischemia based on the highlighting of ischemic signs. This quantification is fully automatic, providing additional information that would be difficult or impossible to efficiently compute using manual methods.
Yes – e-ASPECTS will indicate the presence of non-acute ischemia visually, by highlighting regions with significant hypodensity in the CT scan in a different way (hatched orange shading) to the highlighting of the acute ischemic signs (solid red shading). The volume of non-acute ischemia can also be estimated. Note that ASPECTS points are not subtracted for regions containing only non-acute ischemia (without acute ischemia). Therefore, a scan containing only non-acute ischemia would receive an ASPECTS score of 10.
Yes – e-ASPECTS includes a manual editing feature via the web browser user interface, which allows clinicians to review the automated e-ASPECTS score and select or deselect ASPECTS regions to determine their own result. This result can then be published to other users via email notifications and DICOM (PACS) results, in addition to being viewable in the web browser user interface. Manually adjusted results are clearly labelled as such, to distinguish them from automated e-ASPECTS results.
No – e-ASPECTS only assesses ischemic damage within the MCA territory, which accounts for the overwhelming majority of all strokes.
No – e-ASPECTS is only indicated for use on acute ischemic stroke patients. Any results generated for hemorrhagic stroke patients will be incorrect or invalid. It is up to the physician using e-ASPECTS to ensure that the patient is suffering an ischemic stroke, and that there is no bleed visible in the scan, before using the e-ASPECTS results.
No – e-ASPECTS is only indicated for use on acute ischemic stroke patients. Using e-ASPECTS on non-stroke patients may lead to processing errors or meaningless / incorrect results.
The CTA-CS is a scale from 0 to 3, where 0 represents no collaterals in the area affected by the stroke, and 3 indicates excellent collaterals (Tan et al., AJNR, 2009). There is nowadays significant evidence that the presence of good collateral supply is associated with better clinical outcomes in patients with acute stroke due to large vessel occlusions.
e-CTA is designed for use on brain CTA scans of acute ICA or MCA stroke patients. It assesses collaterals in the MCA territory, and is most suitable for patients with suspected large vessel occlusion.
e-CTA has been validated with a dataset of single-phase CTA scans from multiple sites, and it is intended that you will be able to continue using your hospital’s existing CTA protocol with the software. It is anticipated that multiphase CTA protocols will also be supported, and Brainomix engineers will ensure that CTA acquisition parameters are compatible with e-CTA during installation.
Yes – in a similar way to e-ASPECTS, the e-CTA automated result can be manually edited via the web browser user interface, and published to all result formats.
The assessment of the brain CT perfusion or MRI scan of an acute ischemic stroke patient is a crucial step towards treatment decisions. Olea Sphere® delivers a rapid, robust and standardized assessment of mismatch estimation from CT perfusion scans of acute ischemic stroke patients, thereby introducing confidence, consistency and speed into the physician’s clinical decision making.
The e-Mismatch report, automatically generated in around 1 minute, includes the key information to help the stroke team with the treatment decision: Penumbra Volume, Core Volume, and Mismatch Ratio.
e-STROKE SUITE is provided as a managed appliance running on either virtualized or physical hardware. Typically, a virtual machine server is provisioned by the hospital IT department, and Brainomix engineers will work with hospital technicians to install e-STROKE SUITE software and connect it via the DICOM network protocol to the CT scanners and PACS systems.
Typically, thin-slice CT, CTA, CTP or MRI data is sent from the CT/MRI scanner workstation to e-STROKE SUITE by the radiographer, with a suitable head / stroke protocol set up on the workstation to streamline the process. The e-STROKE SUITE server will process the scan and send results approximately 1-2 minutes later to the PACS and via pseudonymized email notifications. Results can also be viewed with an iPad or a web browser on a computer connected to the hospital network (either on-site, or remotely via any existing hospital VPN solutions, e.g. Citrix).
New or existing CT, CTA, CTP and MRI stroke protocols can be used, with protocol recommendations for each modality available from Brainomix and Olea. Brainomix engineers will work with the hospital staff to ensure that the scanning protocol is appropriate.
Yes – e-STROKE SUITE supports all the major scanner and PACS manufacturers. Use of the standard DICOM network protocol for communication means that results should be easy to view in the existing hospital PACS and other DICOM-compliant radiology systems. Brainomix engineers will work with the hospital staff to ensure that these connections are tested prior to the system going live.
Typically, results will be generated within 1-2 minutes of the scan being sent to e-STROKE SUITE. Results will then be available immediately in the web browser user interface (available on iPads and computers connected to the hospital network), and soon afterwards on PACS and via email notifications (typically within a few seconds, depending on network speed).
Yes – e-STROKE SUITE results can be accessed outside the hospital via email notifications and via the web browser user interface. To ensure the security of patient data, email notifications contain pseudonymized results. These can be used on devices such as mobile phones and laptops with access to the hospital email system. If you have an existing remote access solution (VPN, Citrix etc.) then you can use this to access e-STROKE SUITE web browser user interface from outside the hospital, providing full access to results.
Confidential patient data are stored on e-STROKE SUITE server inside the hospital, and not transmitted externally. Access to e-STROKE SUITE server is limited to secure channels, even from within the hospital network. e-STROKE SUITE results transmitted via email notifications are pseudonymized, with only the patient ID and scan time linking the results to the records stored within hospital systems.
It is possible that scan artifacts such as motion streak artifacts, excessive beam hardening artifacts, or very large areas of non-acute ischemia, will prevent e-STROKE SUITE modules from successfully processing and scoring the scan. In general, if an expert cannot read the scan, the software may also fail to produce a result. When this occurs, a notification of failure will be generated.
All clinical users will be invited to a group presentation about best practices in stroke image interpretation and the clinical utility of e-STROKE SUITE, followed by hands-on training in small groups, on-site at the hospital. In-application help is also provided with the browser-based e-STROKE SUITE user interface.
If you would like to request additional training, this can be arranged (additional costs may be incurred for extra training). Please get in touch with your primary Brainomix or Olea Medical contact, or email firstname.lastname@example.org, to arrange this.
The site will have been provided with a Service Level Agreement (SLA). This describes the support provided by Brainomix, via telephone or email, during UK working hours. Simply call +44 1865 582740 during UK business hours or email email@example.com to notify Brainomix engineers of any problems you are experiencing.
The first step in the support process is for Brainomix engineers to try to rectify the problem remotely. However, if this is not possible, we will schedule an on-site visit in conjunction with the lead user and hospital technicians.
The e-STROKE SUITE software is typically updated once or twice a year.
Updates can include image scoring improvements, better visual output, improved device support, user interface improvements, security updates, and general fixes. New modules may also be made available over time.
When a new version update is available, support staff will contact the lead user to schedule the update. Once this is approved, support engineers will remotely update e-STROKE SUITE service and test that the update was successful together with the hospital technicians. The update process will include e-STROKE SUITE service being unavailable for a short period (typically 1 hour).