Abstract 4141704: An Innovative, Non-invasive, Credit-Card Sized Device for Ambulatory 12 Lead ECG Recording: First-In-Human Experience Compared to Standard 12 Lead ECG

Background: The multiple electrodes needed to generate a 12-lead electrocardiogram (12L ECG) limits its use to traditional health care settings. An innovative credit-card sized unit (HeartBeam, Santa Clara, CA, USA) when placed on the chest without cables captures a vectorcardiogram (VCG). A personalized transformation matrix (PTM) then converts the signals into a 12L ECG. Objective: This is the first quantitative (standard intervals and amplitudes) and qualitative (rhythm diagnosis) accuracy assessment of a synthesized 12L ECG (Syn 12L) compared to a simultaneously recorded standard 12L ECG (Std 12L) on patients in sinus rhythm (SR) or in a non-life-threatening arrhythmia. Methods: The 80 patients, who were enrolled at a single center (Dedinje Cardiovascular Research Institute, Belgrade, Serbia), first underwent recording of a Std 12L and VCG to create a unique PTM, which was used to create the Syn 12L from the VCG. Then a simultaneous Std 12L and VCG were recorded. The quantitative endpoint was the calculated difference (mean and standard deviation [SD]) between the Syn 12L and Std 12L in a series of intervals (RR, PQ, QJ, and QT) and amplitudes (P wave, R wave, and T wave). For the qualitative endpoint, 2 blinded electrophysiology physicians (EP) classified the Syn 12L and Std 12L arrhythmia status. Results: Of the 80 patients, 41 were in SR and 39 in another rhythm (3:SR with PACs, 5:SR with PVCs, 1:SR with pre-excitation, 16:atrial fibrillation, 3:atrial flutter, 2:atrial pacing, and 9:ventricular pacing). The interval and amplitude differences are listed in the table. Rhythm classification by the blinded EPs demonstrated a sensitivity of 94.9% (95% CI: 82.7-99.4%) and specificity of 100% (95% CI: 91.4-100%) compared to Std 12L. Conclusion: In this first study comparing the performance of a 12L ECG created from a credit card sized VCG recorder, the 12L Syn demonstrated clinically equivalent interval and amplitude accuracy and excellent agreement in arrhythmia classification when compared to a simultaneously recorded 12L Std. This approach holds significant promise, potentially permitting patients to obtain a 12L ECG outside of a health care setting with a compact, easy to use device.