FFR Calculation Stability Index for Coronary Stenosis
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Solution Overview
Problem
Current systems for calculating fractional flow reserve (FFR) in coronary arteries are inaccurate and require clinician adjustment, leading to inconsistent revascularization decisions due to variations in data window selection.
Innovation Solution
A system and method that utilize a catheter with dual pressure sensors to simultaneously measure pressures on both sides of a stenosis, and an FFR calculation module to identify an optimal time window based on stability indexes indicating heart rate and catheter stability, thereby calculating a reliable FFR value.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If FFR calculation uses a fixed time window, then the calculation process is simple, but the accuracy and reliability of FFR values vary due to clinician judgment differences
Solution Approach 1:
The system dynamically adjusts the time window for FFR calculation based on real-time analysis of pressure data stability and heart rate variability. Instead of using a fixed time window, the system identifies optimal time windows where the pressure data exhibits minimal variability and stabilizes, ensuring accurate FFR measurements while adapting to each patient's physiological conditions
Solution Approach 2:
The system continuously monitors pressure data from the catheter and provides feedback to adjust the calculation parameters. By analyzing the stability of pressure measurements and heart rate variations in real-time, the system automatically refines the time window selection, creating a closed-loop control system that improves measurement accuracy without requiring manual clinician intervention
2Reliability
If pharmacological agents are administered to stabilize vascular resistance, then FFR measurement reliability improves, but the procedure complexity and time required increase
Solution Approach 1:
The system enables self-service by automatically identifying optimal measurement windows based on intrinsic physiological markers in the pressure data itself. The algorithm detects when pressure stabilizes and heart rate variability decreases, allowing the system to autonomously determine the best time for FFR calculation without requiring external pharmacological agents or manual timing by clinicians
3Measurement precision
If multiple pressure measurements are taken over extended periods, then data reliability improves, but the time required for procedure increases
Solution Approach 1:
The system performs preliminary analysis of pressure data as it is being collected, continuously assessing stability metrics and heart rate variability. This allows the system to predict when optimal measurement conditions will be achieved and prepares the calculation framework in advance, enabling rapid FFR determination once the optimal window is reached without requiring extended waiting periods
Data Source
AI summary
A system and method for evaluating blood flow in a vessel of a patient includes a catheter containing a first pressure sensor and a second pressure sensor and configured to simultaneously measure pressure data within a vessel on either side of a stenosis. Pressure data generated by the catheter includes a first series of pressure measurements from the first pressure sensor a second series of pressure measurements from the second pressure sensor. The system and method further includes a fractional flow reserve (FFR) calculation module executable on one or more processors and configured to calculate a stability index for each of two or more portions of the pressure data, wherein each stability index indicates at least one of heart rate stability and catheter stability for the respective portion of the pressure data. An optimal time window is identified based on the stability indexes for calculation of FFR based on the pressure data. A FFR value is then calculated based on the pressure data in the optimal time window.