HeartBeam – a Personal Risk Assessment Device in Patients with Chest Pain

Introduction: Early prehospital chest pain assessment improves acute coronary syndrome (ACS) outcomes and can reduce unnecessary Emergency Room (ER) visits but requires medical personnel and electrocardiographic (ECG) equipment.

Objective: To evaluate the feasibility of a personal credit-card size cell phone-connected chest pain self-assessment device (HeartBeam) in diagnosing ACS.

Methods: HeartBeam estimates ACS risk by serial likelihood ratio analysis of 3 components: pre-existing coronary heart disease risk, chest pain characteristics, and leadless near-orthogonal 3-lead self-recorded ECG with optional comparison to baseline. Final ACS risk is graded as High/Intermediate/Low. High risk is considered positive for ACS.

Results: 184 ER patients with chest pain (Age 57± 9 years, M ± SD), 90 Male, 43 (23%) ACS underwent HeartBeam assessment (96 learning, 88 test set). ACS sensitivity was 28/28 (100%) in learning and 15/16 (94%) in test set with specificity of 43 and 42% respectively in total cohort. In the subset of patients with existing HeartBeam baseline ECG (n=110) sensitivity was 17/17 (100%) and 11/12 (92%), specificity 54% and 58% in learning and test set, respectively (p>0.1 with no baseline). Single patient missed by the analysis had known coronary disease with usual anginal episode resulting in troponin leak. In baseline recording analysis 41/110 patients were classified as Low risk compared to 18/184 without baseline (p<0.001), all negative for ACS.

Conclusion: HeartBeam chest pain self-assessment device provides accurate ACS detection. If confirmed in larger studies, it can be used to facilitate outpatient chest pain assessment and triage by remote physicians and patients themselves.