Abstract
PURPOSE: In a comparator study, designed with assistance from the Food and Drug Administration, a State-of-the-Art (SOTA) ECG device augmented with automated analysis, the comparator, was compared with a breakthrough technology, Cardio-HART (CHART). METHODS: The referral decision defined by physician reading biosignal-based ECG or CHART report were compared for 550 patients, where its performance is calculated against the ground truth referral decision. The ground truth was established by cardiologist consensus based on all the available measurements and findings including echocardiography (ECHO). RESULTS: The results confirmed that CHART analysis was far more effective than ECG only analysis: CHART reduced false negative rates 15.8% and false positive (FP) rates by 5%, when compared with SOTA ECG devices. General physicians (GP's) using CHART saw their positive diagnosis rate significantly increased, from ~10% to ~26% (260% increase), and the uncertainty rate significantly decreased, from ~31% to ~1.9% (94% decrease). For cardiology, the study showed that in 98% of the cases, the CHART report was found to be a good indicator as to what kind of heart problems can be expected (the 'start-point') in the ECHO examination. CONCLUSIONS: The study revealed that GP use of CHART resulted in more accurate referrals for cardiology, resulting in fewer true negative or FP-healthy or mildly abnormal patients not in need of ECHO confirmation. The indirect benefit is the reduction in wait-times and in unnecessary and costly testing in secondary care. Moreover, when used as a start-point, CHART can shorten the echocardiograph examination time.