TOFI Score Predicts ToF Mortality via BNP Biomarkers
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Solution Overview
Problem
Current methods for assessing the severity of Tetralogy of Fallot (ToF) in children are limited by high false-negative and false-positive error rates, inability to accurately predict mortality risk, reliance on invasive procedures, and lack of a quantitative scoring system for prioritizing surgical resources, leading to under-prediction of mortality risk and unfair allocation of surgical capacity.
Innovation Solution
A system and method using serial measurements of Brain Natriuretic Peptide (BNP) levels to calculate a Tetralogy of Fallot Index (TOFI) score, which applies a Cox Proportional Hazards model for predicting mortality risk and prioritizing surgical interventions based on a predictive model that includes z-score transformations of BNP and velocity measurements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional methods for assessing ToF severity are used, then diagnostic simplicity is maintained, but measurement precision and reliability are poor due to high false-negative and false-positive error rates
Solution Approach 1:
The patent transforms the assessment from qualitative clinical judgment to quantitative measurement by using BNP levels and their rate of change as numerical parameters. This enables precise measurement of disease severity through blood tests, directly resolving the contradiction between measurement precision and system complexity.
Solution Approach 2:
The patent introduces BNP as an intermediary biomarker that mediates between the complex physiological state of ToF and the simplified diagnostic measurement. By measuring BNP levels in blood, the system achieves high measurement precision without requiring complex direct assessment of cardiac function.
2Measurement precision
If invasive procedures are used for assessment, then measurement precision may be improved, but ease of operation and patient comfort deteriorate
Solution Approach 1:
The patent replaces invasive mechanical procedures (such as cardiac catheterization) with a biochemical measurement system that analyzes BNP in blood samples. This substitution maintains high measurement precision for mortality risk prediction while dramatically improving ease of operation and reducing patient discomfort.
Solution Approach 2:
BNP serves as a non-invasive intermediary that provides accurate mortality risk prediction without requiring direct invasive measurement of cardiac function. The biomarker translates complex physiological information into a simple blood test measurement.
3Productivity
If no quantitative scoring system is implemented, then device complexity is reduced, but productivity and resource allocation efficiency deteriorate due to inability to prioritize surgical resources
Solution Approach 1:
The patent segments the assessment into distinct quantitative components: current BNP level, rate of change of BNP, and the composite TOFI score. This segmentation enables efficient resource allocation by providing clear prioritization metrics, directly improving productivity in surgical resource management.
Solution Approach 2:
The patent incorporates the dynamic element of BNP rate of change into the scoring system, making the assessment responsive to disease progression. This dynamic approach improves resource allocation efficiency by identifying patients whose condition is deteriorating, requiring urgent intervention.
Data Source
AI summary
Systems and methods are provided for managing treatment of children with a congenital cyanotic heart condition such as Tetralogy of Fallot (ToF) including determining predicted survival probabilities within a timeframe wherein patients await medical treatment such as surgical correction, based on amounts of a biomarker, such as BNP (brain natriuretic peptide) in serial samples of blood plasma from the subject and determining a Tetralogy of Fallot Index (TOFI®) score from the biomarker values. Some embodiments use TOFI score to determine severity and include scheduling and prioritizing medical treatment for patients based on the severity. In some embodiments, the TOFI score is calculated from a plurality of biomarker measurements, which are log-transformed and z-score transformed, by a mathematical survival predictive model, such as a Cox Proportional Hazards model. In some embodiments, the method is implemented on a mobile device, such as a smart-phone or tablet application, or via web-based or cloud-based computing services.