Key result
Guardian intracardiac monitoring proves cost-effective vs standard care in high-risk ACS at ~$58,668/QALY.
Why the study?
The ALERTS randomized clinical trial evaluated an intracardiac monitor with real-time alerting in high-risk acute coronary syndrome patients, but its cost-effectiveness was unknown.
Is continuous real-time intracardiac monitoring with patient alerting cost-effective compared to standard-of-care in high-risk acute coronary syndrome patients?
Is continuous real-time intracardiac monitoring with patient alerting cost-effective compared to standard-of-care in high-risk acute coronary syndrome patients?
Effect estimate: ICER $58,668/QALY
Real-time intracardiac monitoring with patient alerting is cost-effective at conventional thresholds for high-risk ACS patients.
May support Guardian use in high-risk ACS; leaves open randomized confirmation of outcomes and costs.
BACKGROUND: ALERTS was a pivotal randomized clinical trial (RCT) evaluating an intracardiac monitor with real-time alerting in high-risk acute coronary syndrome patients. The cost-effectiveness however is unknown. METHOD: A decision model estimated health effects and costs of implanting a Guardian device in a target patient population, compared to current standard-of-care (SOC). Health and economic outcomes were modeled using ALERTS trial results and relevant literature. RESULTS: Base-case analysis indicated an incremental lifetime cost of $21,988 with Guardian as compared to SOC (increase of 0.18 life years or 0.37 quality-adjusted life years (QALY)). The incremental cost-effectiveness ratio (ICER) was $121,056/LY or $58,668/QALY. CONCLUSION: Real-time intracardiac monitoring with patient alerting was cost-effective using conventional thresholds in acute coronary syndrome (ACS) patients at high-risk for recurrent events.
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Schmidler et al. (2025) studied High-risk acute coronary syndrome. Guardian device (intracardiac monitor with real-time alerting) vs. Current standard-of-care (SOC) was evaluated on Incremental cost-effectiveness ratio (ICER) (ICER $58,668/QALY). Implanting a Guardian device for real-time intracardiac monitoring was cost-effective compared to standard-of-care in high-risk ACS patients, yielding an ICER of $58,668/QALY.
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