Abstract 4367738: Diagnostic Accuracy of a Novel 3-Lead ECG System compared to Standard 12-Lead ECG for Detection of Acute Ischemia

Abstract

Background: Timely presentation of patients with ST-segment elevation myocardial infarction (STEMI) is critical for reducing mortality and improving clinical outcomes. Prehospital delays with a median symptom-to-call time over 2.5 hours, is a major barrier. To address this, a novel credit card-sized device (HeartBeam, Santa Clara, CA, USA) that records 3D, 3-lead ECG – similar to Frank's XYZ heart vectors – is being evaluated. Unlike most ambulatory ECGs that record only coplanar signals, this 3D, 3-lead device provides a more complete view of the heart’s electrical activity, enabling ischemia detection. Objective: To assess the diagnostic accuracy of the non-coplanar 3-lead ECG compared to simultaneously recorded standard 12-lead ECG for the detection of acute ischemia. Methods: 66 consecutive patients with angiographically confirmed coronary artery disease suitable for percutaneous coronary intervention (PCI) were enrolled. Transient coronary artery occlusion using a balloon catheter during the PCI procedure (target duration 90 seconds), served as a model for myocardial ischemia. Since this was a proof-of-principle study, a standard 12-lead ECG with four additional electrodes placed in the positions corresponding to the 3D, 3-lead ECG system was used. Both 12-lead and 3-lead signals were recorded simultaneously throughout the procedure. Cardiologist readers evaluating both ECG types, were not asked to apply ST-segment criteria for acute ischemia. Instead, they provided a binary expert judgement on presence of acute ischemia (Yes/No). The study was conducted at Clinical Center of Serbia, Belgrade. Results: A total of 120 set of recordings were made during balloon occlusions, along with 66 negative pre-occlusion recordings. The 3-lead ECG demonstrated sensitivity and specificity of approx. 75% and 69%, respectively, compared to 83% and 66% for the 12-lead ECG. When the 3-lead ECG was overlaid with an asymptomatic baseline (as in the product version), sensitivity was 73% and specificity increased to 96%. Additional statistical results are shown in the figure. Conclusion: The study results demonstrate that the 3D 3-lead ECG detected acute ischemia with performance comparable to standard 12-lead ECG. With the baseline overlaid, the 3D 3-lead system achieved higher accuracy than the standard 12-lead ECG in detecting ischemia. This user-friendly, always-with-the-patient system may help reduce symptom-to-door time for STEMI patients.