ECG Evaluation Using Z-Score Standards
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Solution Overview
Problem
Current ECG machines lack reliable, automated interpretation of ECG variables due to outdated normative standards based on limited subject data, leading to inconsistent and subjective diagnoses, which can result in misdiagnosis of life-threatening heart conditions and hinder large-scale screening programs.
Innovation Solution
Development of a novel ECG evaluation system using Z-scores derived from the largest historical cohort of 27,085 healthy subjects, with a database and computer algorithm to provide objective, reproducible diagnosis through a Novel Extended ECG Report (NEER) for 102 ECG variables, enabling accurate detection of cardiac pathology.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated ECG interpretation is implemented using outdated normative standards, then productivity increases through automation, but measurement precision deteriorates due to limited subject data (as few as 80 persons per age group)
Solution Approach 1:
The patent transforms ECG variable values into Z-scores, changing the parameter representation from raw measurements to standardized scores that can be objectively compared against normative data, thereby improving measurement precision while maintaining automated interpretation
Solution Approach 2:
The patent pre-establishes comprehensive normative ECG data from a large historical cohort (27,085 healthy subjects) before automated interpretation is performed, allowing the system to compare patient data against pre-computed Z-score thresholds and achieve both automation and precision
2Measurement precision
If subjective interpretation by medical professionals is used, then measurement precision may be maintained through expert knowledge, but productivity decreases due to lack of automation and significant interpersonal variation
Solution Approach 1:
The ECG machine performs self-interpreation by automatically comparing measured ECG variables against stored normative data and Z-score thresholds, eliminating the need for manual interpretation while maintaining objective precision through standardized algorithms
Solution Approach 2:
The system provides automated feedback by generating diagnostic recommendations based on Z-score comparisons, allowing the machine to self-evaluate ECG results without requiring continuous human intervention, thereby increasing productivity while maintaining precision through consistent application of diagnostic criteria
3Measurement precision
If comprehensive ECG variable assessment is performed on all 102 variables, then measurement precision improves through detailed evaluation, but device complexity increases due to the large number of variables and leads
Solution Approach 1:
The patent extracts only the essential ECG variables and intervals (102 specific parameters) from the complete ECG signal for standardized assessment, separating the critical diagnostic information from the full complexity of the raw ECG data, thereby improving measurement precision while managing device complexity through focused variable selection
Data Source
AI summary
A system and methods for the assessment of cardiac status of a subject are provided. In embodiments, a method includes an electrocardiogram (ECG) machine recording electrical ECG information for a plurality of ECG variables from an examined subject; digitally transforming the electrical ECG information to digital values of the ECG variables; comparing the digital values of the ECG variables from the examined subject with normative data stored in a database, wherein the normative data is based on healthy individuals; assigning predictive Z-scores to the digital values of the ECG variables based on the normative data; establishing a diagnosis of the examined subject based on a determination that the predictive Z-scores are within normal limits or are outside normal limits of the normative data; and generating a report including the diagnosis of the examined subject.