Abstract
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.