Cost-effectiveness of continuous real-time intracardiac recurrent event detection and alerting in high-risk acute coronary syndrome patients

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. 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. 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. 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. ALERTS was a clinical trial that evaluated the clinical benefits and risks of the “Guardian” implantable heart monitor. Guardian provides real-time alerts to high-risk, heart-attack patients, so they can get to a hospital in a faster and more reliable manner, even for silent heart attacks. However, the cost-effectiveness of implementing this new clinical option is unknown. We used a model to compare the health benefits and costs of implanting the Guardian device versus the current standard of care and used data from the ALERTS trial and other relevant studies. The analysis showed that using Guardian increased the lifetime cost by $21,988 compared to standard care. It added about 0.18 more life years or 0.37 quality-adjusted life years (QALY). The cost per additional year of life was $121,056, or $58,668 per QALY. The study found that real-time heart monitoring and alerting to recurrent events, is cost-effective for high-risk heart attack patients based on standard for cost-effectiveness thresholds.