AE-1010 Rhythm Express: Interval and Arrhythmia Analysis Software
Maximize the Value of Every ECG Study
The AE-1010 Rhythm Express Interval and Arrhythmia Analysis Software is intended for use in preclinical and clinical research studies. It is not approved by the FDA for use in clinical patient monitoring.
Unique Server-based Solution
AE-1010 is hosted on a local validated server. This offers several advantages including:
- Validated software is hosted on a controlled system configuration using a secure high-performance server. User validation is limited to testing with your own data.
- Internal infrastructure and operating costs are eliminated. The server software can be accessed remotely by any PC based on Windows, Mac, or Linux operating systems.
- Software upgrades are automatically available as they are released while legacy software versions remain available for use.
- VivaQuant performs routine periodic installation qualification testing as Windows updates are pushed out to assure compatibility.
- Validated for use in humans and preclinical research models, facilitating translation from preclinical to clinical studies.
Accurate Detection of ECG Intervals and Arrhythmias
Accurate ECG analysis results start with high quality ECG signals. To that end, the AE-1010 software uses VivaQuant's patented MDSPTM technology [1] to eliminate 95% of noise while preserving fidelity, enabling highly sensitive and accurate measurements from continuous ECGs in freely moving animals. This is accomplished by dividing the cardiac cycle into two windows — a first window surrounding the QRS complex and a second window that includes the remainder of the cardiac cycle. Since the information content in the QRS complex is quite different than the information contained in the remainder of the cardiac cycle, spatially selective filtering is applied to remove noise. MDSP circumvents the limitations of conventional filtering techniques by decomposing the ECG into multiple mathematical domains with each domain containing a different characteristic of the signal. Domains containing noise are discarded and the ECG signal is then reconstructed from the remaining domains, free of distortion and noise. Once noise is removed, AE-1010 is able to more accurately identify fiduciary marks to reduce variability in interval measurements [2], especially QT interval where the gradual slope of the T-wave in the presence of noise can result in premature T-offset detection [3].
MDSP divides each cardiac cycle into two windows; one surrounding the QRS complex and a second surrounding the remainder of the cardiac cycle. MDSP takes advantage of the difference in signal charactertistics between these two windows to remove noise.
The AE-1010 software includes a powerful review and editing tool that provides automatic and manual assignment of "Uninterpretable" sections of ECG data where data quality is simply too poor to retrieve useful information. Reported results include PR, QRS, QT, QTc and RR intervals as well as ventricular and supraventricular ectopy (VE and SVE), late and dropped beats and 10 additional arrhythmias. T-wave morphology quantification is optionally available [4].
Efficient Workflow
Efficiency features are around every corner of the AE-1010 software. ECG recordings can be automatically loaded and analyzed in large groups, with a typical 24hr recording taking about 30 seconds to analyze. And that is where the fun starts! The Review function implements two primary presentation views tailored to Interval and Arrhythmia review workflows with ample functions to quickly review and edit results for your specific workflow and target study endpoints. AE-1010 facilitates fast and efficient processing with typical time to analyze, review, edit, and prepare a report for a 24hr recording of 10-20 minutes.
Both presentation views display the denoised ECG trace with marks for P-onset, Q-onset, R-peak, S-offset and T-offset as well as an interval table and optional display of beat classes. AE-1010 also provides a "Beat Class" view where groups of beats are classified according to morphology and statistical similarity. This allows, for example, ventricular ectopic beats to be grouped and viewed by morphology and beats corrupted by certain types of noise to be viewed together for editing. AE-1010 includes powerful features to review and edit the contents of each beat class including combining, deleting, and reassigning beats.
Interval Review
The Interval Review presentation adds graphical display of trend plots for beat-to-beat PR, QRS, QT, and RR intervals with user-selectable colors for VE, SVE, late, dropped, noise, deleted and statistical outlier beats. Individual beat types can be rapidly searched and changed or deleted individually or as a group. QT/RR features allow identification and deletion of outlier QT/RR pairs and also allow application of common QTc corrections including Bazzett's, Fridericia's, Van de Water's as well as individual linear or parabolic corrections.
Interval review presentation showing 2-hour beat-to-beat trend plots for PR, QT, and RR intervals, 20 seconds of raw and denoised Lead II ECG trace including a Tachy arrhythmia and beat-to-beat interval table. QT/RR beat density plot is overlaid. Colored bars displayed above the trend plots indicate the locations of arrhythmias.
Arrhythmia Review
The Arrhythmia Review presentation incorporates the ability to selectively search for one or more arrhythmia types along with the ability to add, delete, or change the type of each arrhythmia event. Once edits have been made in either presentation, Arrhythmia Review incorporates a ReDetect feature to verify that arrhythmia events still meet the qualifying criteria and suggest changes or deletions.
Arrhythmia review presentation showing two input ECG channels, Tachycardia detection, beat class view and beat-to-beat interval table.
Open Architecture
The AE-1010 software supports many file formats including DataquestTM, PonemahTM, HL7, ISHNE, MatlabTM, EDF, and several Holter recorder formats including devices from Intricon, TZ MedicalTM, and BraemarTM. Results can be incorporated into a formatted PDF report and/or exported to .csv files for further analysis in Excel or your favorite statistics software. The native AE-1010 file format complies with the EDF standard which allows reading the AE-1010 ECG data from many existing programs.
Ease of Validation and GLP Compliance
AE-1010 is designed to be 21CFR part 11 compliant and leverages WindowsTM account security for robust security administration with separate user group functions for standard and quality assurance roles. AE-1010 also implements robust tracking of analysis settings and review actions to individual users along with an Audit trail report function. The accuracy of automated interval and arrhythmia detection allows for a simplified workflow to create reports and limits the scope of necessary validation efforts. Use from a secure validated server minimizes validation efforts and system maintenance. In addition, there are very few analysis settings compared to other ECG analysis programs, greatly simplifying the scope of the GLP validation process.
Reports
Reports can be created in graphical and tabular PDF format. All interval, arrhythmia and event results can be exported to .csv files for use in MicrosoftTM ExcelTM, SASTM or your favorite statistics or graphics program.
Numeric table of hourly results.
Formatted graphical PDF report.
[1] US Patents 8,632,465, 8,478,389, 8,433,395, 8,543,195, 8,688,202. Additional US and foreign patents pending.
[2] Brockway, M., Hamlin, R., Evaluation of an Algorithm for Highly Automated Measurements of QT Interval. J. Pharmacol. Toxicol. Methods. 64(1): 16-24 (2011).
[3] Malik, M., Batchvarov, V., Measurement, Interpretation and Clinical Potential of QT Dispersion. JACC, 36(6): 1749-66 (2000).
[4] Johannesen, L. et.al., Differentiating Drug-Induced Multichannel Block on the Electrocardiogram: Randomized Study of Dofetilide, Quinidine, Ranolazine, and Verapamil. Clin. Pharmacol. Ther., 96(5): 549-58 (2014).