Soluble ST2 Biomarker for Cardiac Device Selection
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Solution Overview
Problem
Current methods for selecting treatment for ventricular tachyarrhythmia (VTA) events, particularly in patients with implanted cardiac devices, are unable to accurately predict which subjects will benefit most from device therapy, leading to inefficiencies in patient care.
Innovation Solution
Determining the level of soluble ST2 in biological samples and comparing it to reference levels to select, implant, replace, or reprogram cardiac devices such as ICDs, CRTs, or CRT-Ds, and using additional biomarkers like BNP and NT-proBNP to stratify patients for treatment and clinical studies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If implanted cardiac devices are used for treating ventricular tachyarrhythmia patients, then patient survival is improved, but the inability to predict which subjects will benefit most leads to inefficient resource utilization and increased device complexity
Solution Approach 1:
The patent applies preliminary action by measuring soluble ST2 levels before device implantation to predict which patients will benefit from ICD therapy. This biomarker assessment is performed in advance to guide treatment selection, preventing unnecessary device implantations and optimizing patient outcomes before the actual treatment begins.
Solution Approach 2:
The patent uses parameter changes by measuring the concentration of soluble ST2 biomarker in patient samples to determine treatment eligibility. This biochemical parameter serves as an objective criterion to differentiate between patients who will and will not benefit from device therapy, replacing subjective clinical judgment with quantifiable biomarker data.
2Measurement precision
If soluble ST2 biomarker testing is implemented to predict VTA events, then treatment precision is improved, but the complexity of diagnostic procedures increases
Solution Approach 1:
The patent replaces mechanical or manual diagnostic assessment with a biochemical measurement system. Instead of relying on complex clinical evaluations and multiple diagnostic tests, the invention uses a specific biomarker assay (soluble ST2 measurement) to objectively predict VTA risk and guide treatment decisions.
3Productivity
If cardiac devices are implanted in all eligible patients, then more patients receive potentially life-saving treatment, but unnecessary device implantations increase healthcare costs and procedural burden
Solution Approach 1:
The patent applies local quality by tailoring treatment to individual patient characteristics through soluble ST2 biomarker levels. Instead of uniform treatment protocols, the invention identifies specific patient subgroups based on their biomarker profile, ensuring that device therapy is directed precisely to those who will benefit while sparing others from unnecessary procedures.
Data Source
AI summary
Provided herein are methods that include (i) determining a level of soluble ST2 in a biological sample from a subject, (i) comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2 (e.g., a level of soluble ST2 in the subject at an earlier time point), and (iii) selecting, implanting, replacing, or reprogramming an implanted cardiac device, e.g., an ICD, CRT, or CRT-D device, for a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2, or selecting a subject for participation in, or stratifying a subject participating in, a clinical study of a treatment for reducing the risk of a ventricular tachyarrhythmia (VTA) event. Also provided are methods for evaluating the risk of a VTA event in a subject. Also provided are kits for performing any of these methods.