Wearable ECG Stability Index for SCD Risk Prediction

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Solution Overview

Problem

Current methods for predicting and preventing sudden cardiac death (SCD) are inadequate due to the inability to identify predictive factors in time for effective intervention, especially in individuals without prior cardiac disease, and existing treatments are often ineffective or invasive, with a lack of timely and specific preventive measures for ambulatory patients.

Innovation Solution

A system using noninvasive, portable electronic devices with signal-processing software and statistical predictive algorithms to calculate a QT dispersion stability index (QTdSI) from electrocardiogram (ECG) signals, providing advance warnings of increased SCD risk through wearable sensors and communication with healthcare providers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional antiarrhythmic drugs are used for SCD prevention, then treatment can be administered, but the effectiveness is largely ineffective and timing is not timely for ambulatory patients

Engineering Contradiction:
Improveeffectiveness of SCD preventionVSAvoidtiming of intervention
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary assessment of SCD risk by continuously monitoring ECG signals and calculating stability indices before the arrhythmia event occurs. This advance warning enables timely intervention with antiarrhythmic drugs or ICD implantation, transforming post-event treatment into pre-event prevention.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system continuously monitors ECG signals and provides real-time feedback on cardiac stability through calculated indices. This feedback loop enables dynamic adjustment of prevention strategies based on changing cardiac conditions, improving both timing and effectiveness of intervention.

Inventive Principle:
Principle #23Feedback

2Reliability

If ICDs are implanted for SCD prevention, then life-threatening arrhythmias can be treated, but the majority of patients never experience life-threatening arrhythmias and the therapy is invasive and expensive

Engineering Contradiction:
Improveprotection against life-threatening arrhythmiasVSAvoidinvasiveness and cost of therapy
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system identifies patients at high risk of SCD through continuous monitoring and stability index calculation before the arrhythmia event occurs. This enables selective deployment of ICDs or antiarrhythmic drugs only to those who need them, avoiding unnecessary invasive procedures in low-risk patients.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system replaces the need for continuous mechanical monitoring and intervention with a computational approach that uses ECG signal analysis and stability theory to predict arrhythmia risk. This substitution reduces the burden of continuous physical monitoring while maintaining effective prevention.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If comprehensive SCD prevention is implemented, then more patients can be protected, but the ability to identify predictive factors is insufficient and timely intervention cannot be achieved

Engineering Contradiction:
Improveapplicability to broader populationVSAvoidaccuracy of predictive factor identification
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The system transforms ECG signal parameters into stability indices that quantify cardiac stability over time. By calculating changes in these indices rather than relying on single-point measurements, the system achieves more precise prediction of arrhythmia risk across diverse patient populations.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system adds a temporal dimension to ECG analysis by continuously monitoring and comparing stability indices over time. This time-series approach captures dynamic changes in cardiac electrophysiology that static measurements miss, improving predictive accuracy for arrhythmia risk.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

Data Source

PatentUS9585589B2Computerized systems and methods for stability-theoretic prediction and prevention of sudden cardiac death
Publication Date: 2017.03.07 CERNER INNOVATION INC
  • US9585589B2 patent drawing
  • US9585589B2 patent drawing
  • US9585589B2 patent drawing

AI summary

Systems, methods and computer-readable media are provided for automatic identification of patients according to near-term risk of ventricular arrhythmias and sudden cardiac death (SCD). Embodiments of the invention are directed to event prediction, risk stratification, and optimization of the assessment, communication, and decision-making to prevent SCD, and in one embodiment take the form of a platform for wearable, mobile, unteathered monitoring devices with embedded decision support. Thus embodiments relate to automatically identifying persons at risk for arrhythmias and SCD through the use of noninvasive, portable, wearable electronic device and sensors equipped with signal-processing software and statistical predictive algorithms that calculate stability-theoretic measures derived from the digital electrocardiogram timeseries acquired by the device. The measurements and predictive algorithms embedded within the device provide for unsupervised use in the home or in general acute-care and chronic-care venues and afford a degree of robustness against variations in individual anatomy and sensor placement.