Abstract
To determine the potential of a non-invasive acoustic device (CADScor®System) to reclassify patients with intermediate pre-test probability (PTP) and clinically suspected stable coronary artery disease (CAD) into a low probability group thereby ruling out significant CAD. Audio recordings and clinical data from three studies were collected in a single database. In all studies, patients with a coronary CT angiography indicating CAD were referred to coronary angiography. Audio recordings of heart sounds were processed to construct a CAD-score. PTP was calculated using the updated Diamond-Forrester score and patients were classified according to the current ESC guidelines for stable CAD: low < 15%, intermediate 15–85% and high > 85% PTP. Intermediate PTP patients were re-classified to low probability if the CAD-score was ≤ 20. Of 2245 patients, 212 (9.4%) had significant CAD confirmed by coronary angiography ( ≥ 50% diameter stenosis). The average CAD-score was higher in patients with significant CAD (38.4 ± 13.9) compared to the remaining patients (25.1 ± 13.8; p < 0.001). The reclassification increased the proportion of low PTP patients from 13.6% to 41.8%, reducing the proportion of intermediate PTP patients from 83.4% to 55.2%. Before reclassification 7 (3.1%) low PTP patients had CAD, whereas post-reclassification this number increased to 28 (4.0%) (p = 0.52). The net reclassification index was 0.209. Utilization of a low-cost acoustic device in patients with intermediate PTP could potentially reduce the number of patients referred for further testing, without a significant increase in the false negative rate, and thus improve the cost-effectiveness for patients with suspected stable CAD.
Highlights
For detection of stable coronary artery disease (CAD), patients undergo risk stratification, non-invasive and invasive testing [1]
We found that the CAD-score enabled a significant and safe reclassification of patients, which could reduce the need for more expensive testing in patients presenting with chest pain
In patients referred for testing due a suspicion of CAD we reclassified patients from the intermediate pre-test probability (PTP) group into the low probability group for negative CAD-scores
Summary
For detection of stable coronary artery disease (CAD), patients undergo risk stratification, non-invasive and invasive testing [1]. Since a wide range of signal processing algorithms for detection of CAD have been proposed [7, 9,10,11,12,13,14,15,16] Some of these methods have undergone clinical testing [2, 17,18,19,20]. A CAD-score ≤ 20 indicates low probability of CAD and a recent study demonstrated a negative predictive value of 96% in a low to intermediate probability population [2], positioning the device as a potential early rule-out modality before more extensive testing. In the current study we assessed the potential of the CADscore algorithm to reclassify patients suspected of stable CAD from intermediate to low likelihood of CAD, to illustrate the rule-out capacity of the CADScor®System
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