HeartBeam’s 3D-Vector ECG for At-Home Detection of Heart Attacks Evaluated in Foundational Study

August 9, 2023—HeartBeam, Inc., a Santa Clara, California–based cardiac technology company, announced the publication of a foundational study demonstrating the ability of its credit card–size three-dimensional (3D)–vector electrocardiogram (VECG) platform for patient use at home to detect the presence of coronary artery blockages. The study was a collaboration of Harvard Medical School Faculty at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and Clinical Center of Serbia in Belgrade, Serbia.

The study, “Coronary Artery Occlusion Detection Using 3-Lead ECG System Suitable for Credit Card-Size Personal Device Integration” by Alexei Shvilkin, MD, et al, is available online in JACC: Advances, a journal of the American College of Cardiology.

According to the company, the foundational study demonstrated that the HeartBeam VECG technology detects the presence of a coronary occlusion with the same accuracy as a standard 12-lead electrocardiogram (12L ECG). This finding suggests the potential to provide patients with an easy-to-use system to record a diagnostic-quality ECG signal outside of a medical institution, which could improve heart attack detection, speed up access to care, and save lives, stated HeartBeam.

As summarized by the company, the investigators recorded both 12L ECG and VECG signals in patients undergoing percutaneous coronary intervention. Readings were taken before and after a 90-second balloon inflation that occluded the artery, a surrogate for a heart attack. Automated computer analysis of the ST segment of the 12L ECG and VECG was performed. A panel of three cardiologists analyzed the 12L ECGs.

The study showed that the automated analysis of the VECG and 12L ECG signals had similar performance in determining whether the artery was occluded. Also in the study, the human interpretation of the 12L ECGs had significant intra- and interobserver variability, which does not occur with automated readings.

Both the 12L ECGs and VECG readings were analyzed in two ways: a “spot” reading where only a single recording was considered and a “comparative” reading where a separate “normal baseline” recording was available for comparison. The presence of the “normal baseline” recording, a feature that is integral to HeartBeam’s VECG technology, dramatically improved the accuracy of interpretation, increasing the area under the curve from 0.72 to 0.95.

The company noted that in an accompanying editorial comment, “Another Step Toward Early Ischemia Detection?” in JACC: Advances, Jacqueline E. Joza, MD, stated, “The authors should be congratulated on this interesting and beautifully conducted study. The decision to proceed to coronary angiography is made on the complete patient presentation (history and physical exam, ECG, and focused bloodwork). However, we are fast entering into a new world where the ECG may soon take precedence.”

Dr. Joza continued, “One can imagine in the not-so-distant future that smart devices will be able to automatically detect active ischemia in the field, activate a rapid-response team that includes an ambulance and a cath lab team to provide streamlined access, skipping the emergency department altogether.”

HeartBeam’s device, AimiGo, is coupled with a smartphone app and cloud-based diagnostic software system to facilitate remote evaluation of cardiac symptoms by collecting 3D signals of the heart’s electrical activity. Additionally, AimiGo has the potential to provide data for the development of artificial intelligence algorithms.

AimiGo has not yet been cleared by the FDA for marketing in the United States or other geographies, advised the company.