|Guidelines for the LBBB Initiative of the ISCE 2018 meeting|
The presence of left bundle branch block (LBBB) is an important predictor of benefit from cardiac resynchronization therapy (CRT), a heart failure device therapy applied in ~75,000 patients per year in the United States. However, approximately one-third of patients diagnosed with LBBB may not benefit from CRT because they do do not have activation consistent with a true LBBB. To address the need for improved LBBB detection, new “strict” ECG criteria for LBBB, that were indeed shown to better predict benefit from CRT, were recently proposed.
The newly proposed “strict” LBBB criteria include: QRS duration ≥140 milliseconds (men) or ≥130 milliseconds (women), QS- or rS-configurations of the QRS complex in leads V1 and V2, and mid-QRS notching or slurring in ≥2 of leads V1, V2, V5, V6, I and aVL(Strauss DG, et al. Am J Cardiol 2011; https://doi.org/10.1016/j.amjcard.2010.11.010) These new “strict” LBBB criteria are not regularly used and most hospital systems and physicians still use more conventional criteria to diagnose LBBB which could lead to a higher false-positive rate of LBBBs.
This year’s International Society for Computerized Electrocardiology (ISCE) meeting will contain a session on Device Therapies for Heart Failure. One part of the session will focus on diagnosis of LBBB, due to its importance in identifying which patients will benefit from CRT. ISCE and the Telemetric and Holter Initiative (THEW-project.org) invite any interested potential attendees (academic, industry, government) to study the “strict” LBBB diagnosis using their existing or novel methods. The data used in this initiative are from the MADIT-CRT trial conducted at University of Rochester (Rochester, NY). The data will be shared in ISHNE format and available for download in September 2017 (PENDING) with agreement from Boston-Scientific Inc.
The objective of the initiative is to give investigators interested in this field of computerized electrocardiography an opportunity to present the outcome of their automatic algorithm for “strict” LBBB diagnosis as well as their potential algorithm improvements for LBBB detection in heart failure patients included in the MADIT-CRT clinical trial. The 12-lead high-resolution ECGs were recorded before CRT implantation using 24-hours Holter recorders (H12+, Mortara Instruments, Milwaukee, WI, USA) with Mason-Likar lead configuration (the Mortara system provides 10 electrodes and records 8-lead signals [I, II, V1-V6] the other 4 leads are calculated). The first 20-minute ECG signals were recorded while the patients were in a supine position. The sampling frequency was 1 kHz and amplitude resolution 3.75 microVolts.
The investigators can download two datasets of 10-second recordings in ISHNE format and will be expected to electronically submit a set of results in a pre-defined comma separated value (CSV) format. These results will then be processed using a standard reporting system developed at the FDA, and the results will be presented during the ISCE session. To facilitate participant’s algorithm development and testing, the initiative provided a training dataset (including ECGs and LBBB labels, N= ~400 (pending adjudication – see below)) and a validation dataset (ECGs with no LBBB labels, N= ~400 (pending adjudication – see below)). The LBBB labels of the validation dataset as well as the scripts used for statistical analysis and report generation will be released on the THEW website after ISCE 2018 for transparency and to facilitate further research. All ECGs provided in the learning and validation sets have been manually adjudicated for “strict” LBBB presence by 2 independent physicians and differences were resolved by consensus. In detail, the adjudication process was as follows:
1. A median beat was derived from the 10-second ECG. These were constructed using a 10-second window of sinus rhythm beats.
2. The global QRS duration was determined on the median beat across all 12-leads (i.e. butterfly plot). QRS-onset and QRS-offset annotations were manually adjusted where necessary.
3. Visual determination of QS- or rS-configurations in leads V1 and V2 on the median beat in these leads.
4. Visual determination of mid-QRS notching or slurring in ≥2 of leads V1, V2, V5, V6, I and aVL and their starting position relative to the beginning of the QRS complex (in ms). A slur or notch was required to begin after the first 40 ms and before 50% of the QRS duration and also had to end before 2/3rd of the QRS duration. In addition, notches required either a positive-to-negative or negative-to-positive transition associated with an angle >90° as well as a minimum amplitude of >10 microVolts and duration >5ms. A slur consisted of any sign of conduction delay not meeting criteria for a notch.
Of note, the datasets include other forms of left ventricular conduction delay that are not “strict” LBBB. The initiative will provide labels for whether or not “strict” LBBB is present.
The provided data only includes the ECG signals and whether the specific subject is male or female. No other subject information form the trial is or will be made available.
Overall the proposed set of data includes: ~800 files (pending adjudication) recorded in the MADIT-CRT clinical trial (~73% men, ~27% women). The dataset includes 10-second 10-electrode 12-lead Mason-Likar ECGs extracted from 20-minutes continuous ECG recorded in supine position.
Investigators participation and requirements:
The registration is free and any organization is invited to participate to this initiative. The only requirement for participation is to register to the initiative through the THEW Registration system provided below. The participation to the initiative is validated at the time of the upload of the result file to the THEW submission website. The format of the results file will be communicated to all registrants later in 2017.
The deadline for submission is February 28, 2018.
One single upload will be permitted. Submission past this deadline will not be accepted.
The results will be presented on 04/27/2018 (pending) during the ISCE annual meeting to be held at:
The Chateaux Deer Valley
7815 Royal Street East
Park City, Utah 84060
It is planned to have: 1. a presentation from a clinician on the research and importance of LBBB in heart failure and cardiac resynchronization therapy, 2. brief presentations from the best submission(s) from investigators participating in the challenge (these will be selected by an independent committee of experts) and 3. a summary presentation of the results.
OF NOTE: If the number of submissions is too large only a selection of the best submissions will be presented during the conference. Selection criteria include quality of results and proposed slide presentation of the results.
Below is a step-by-step description of the registration process for the LBBB challenge. Any questions should be directed to: Dr. Robbert Zusterzeel (firstname.lastname@example.org) or Dr. Jean-Philippe Couderc (email@example.com)
|Step-by-step registration and guidelines for contributing to the ISCE 2018 LBBB Challenge:|
Step 1: Register and download the training data
Go to THEW website for registration at: (https://redcap.urmc.rochester.edu/redcap/surveys/?s=FKJWWTERA9)
Download the data for ISHNE format (LINK will be provided soon)
Step 2: Process the ECG files
Apply your ECG algorithm to automatically detect “strict” LBBB from the 12-lead ECGs.
Step 3: Upload your results (see specifics in the table below – THESE ARE SUBJECT TO CHANGE AND WILL BE FINALIZED BEFORE THE OFFICIAL START IN SEPTEMBER/OCTOBER 2017)
Please upload your CSV files into the THEW submission website. The link to this website will be sent by email after your registration is completed and processed. Your final results should be saved in a CSV file to be uploaded using the link you received after registering to the initiative.