Abstract
BACKGROUND: Studies have shown that up to 13% of patients presenting to the emergency department (ED) with low-risk chest pain receive further cardiac testing beyond an electrocardiogram and serial cardiac enzymes. The CADScor System is a US Food and Drug Administration (FDA)-cleared device that uses ultra-sensitive phonocardiography to evaluate the risk of significant coronary artery disease (CAD). OBJECTIVE: To evaluate the relative cost-effectiveness of the CADScor system compared with other diagnostic modalities for the evaluation of low-risk chest pain in patients presenting to the ED in the USA. METHODS: A two-part economic model, consisting of a decision analytic tree followed by a short-term Markov model, was developed to compare 1-year costs and outcomes (e.g., quality-adjusted life year [QALY], false-negatives, and related cardiac events) associated with the CADScor System as the first-line test versus other noninvasive cardiac tests from the perspective of the US healthcare system (TreeAge Pro). Model inputs were derived from literature, and costs for treatment strategies were calculated from average US reimbursements associated with Current Procedural Terminology and Medicare Severity Diagnosis Related Group codes. Values were reported in 2023 US dollars (USD). Parameter uncertainty was assessed through a series of deterministic and one-way sensitivity analyses. RESULTS: Base case results demonstrated that a CADScor-First strategy was cost saving compared with other noninvasive cardiac tests without a substantial difference in adverse events. Economic results were consistent when coronary artery disease (CAD) prevalence rates were varied from 2 to 30% and across a variety of sensitivity analyses. The overall cost savings were estimated to be $7.3-15.3 million USD per 10,000 patients with low-risk chest pain. CONCLUSIONS: Use of a CADScor-First strategy in the evaluation of patients with low-risk chest pain presenting to the ED may result in substantial cost savings for the US healthcare system. More research is needed to understand the long-term costs and outcomes of this strategy.