Cardiac Therapy Evaluation Using Staged Parameter Optimization
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Solution Overview
Problem
Current systems for evaluating and configuring cardiac therapy, such as cardiac resynchronization therapy (CRT), face inefficiencies in determining optimal pacing parameters due to the numerous permutations of settings, which can complicate clinical efficiency and effectiveness.
Innovation Solution
The use of external electrode apparatus and computing systems to noninvasively monitor cardiac signals and generate electrical heterogeneity information, allowing for the efficient search and optimization of pacing parameters through stage-wise evaluation of AV and VV timings, and exclusion of undesirable pacing electrodes based on capture thresholds and phrenic nerve stimulation thresholds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple pacing parameters and configurations are evaluated to optimize cardiac resynchronization therapy, then therapeutic efficacy is improved, but device complexity and clinical time increase
Solution Approach 1:
The patent segments the evaluation process into distinct stages: initial lead placement assessment, subsequent pacing parameter optimization, and final configuration. This staged approach breaks down the complex evaluation into manageable phases, reducing clinical time while maintaining therapeutic efficacy through systematic progression through each evaluation stage.
Solution Approach 2:
The patent performs preliminary evaluation of lead placement and basic pacing capture before proceeding to optimize more complex parameters. By assessing fundamental functionality first (lead capture, basic pacing), the system establishes a foundation that guides subsequent parameter optimization, reducing overall evaluation time while ensuring therapeutic effectiveness.
2Reliability
If multiple pacing parameters and configurations are evaluated to optimize cardiac resynchronization therapy, then therapeutic efficacy is improved, but clinical time increases
Solution Approach 1:
The evaluation process is divided into time-efficient stages with clear decision points. The first stage assesses lead placement and basic capture, allowing early termination if leads are malpositioned. Subsequent stages only evaluate additional parameters if previous stages are successful, reducing average clinical time while maintaining optimization potential.
Solution Approach 2:
The patent implements a tiered evaluation approach where essential parameters are evaluated for all patients, while advanced optimization parameters are only assessed for selected cases. This partial evaluation strategy reduces average clinical time while ensuring all patients receive adequate therapy optimization.
3Reliability
If numerous pacing parameter permutations are tested to find optimal settings, then therapeutic efficacy is improved, but ease of operation decreases
Solution Approach 1:
The patent incorporates automated feedback mechanisms that monitor pacing responses and guide parameter selection. The system provides real-time feedback on lead capture, pacing threshold, and resynchronization effectiveness, allowing operators to make informed decisions without manually testing numerous parameter permutations. This automated feedback simplifies operation while maintaining therapeutic optimization.
Solution Approach 2:
The evaluation system performs self-assessment of lead placement quality and pacing parameter effectiveness through automated analysis of cardiac electrical signals. The system independently determines optimal parameters based on measured physiological responses, reducing the burden on operators to manually evaluate numerous parameter combinations while ensuring therapeutic efficacy.
Data Source
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AI summary
Systems and methods are described herein for evaluation and adjustment cardiac therapy. The systems and methods may initially evaluate a first pacing parameter while other pacing parameters are fixed to, for example, nominal values, and determine an effective setting for the first pacing parameter. Then, a second pacing parameter may be evaluated while the first pacing parameter is fixed to the previously-determined effective setting. Each evaluation may not test every possible setting for the pacing parameters, and instead, may utilize various processes to limit the settings to a subset of settings to test.