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CADScor       

Revolutionary CAD rule out system 

(KHK-Ausschluss-Schnelltest)

The CADScor®System has been included as a first line investigation for ruling out suspected stable Coronary Artery Disease by the British National Institute for Health and Care Excellence (NICE), published as of June 2019 

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The intended use of the CADScor®System is to record heart sounds, murmurs and vibration for calculation of a patient- specific score, indicating the risk of presence of coronary stenosis, as an aid in cardiac analysis and diagnosis

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A very high negative predictive value (NPV) allows physicians to exclude CAD with high reliability for patients with a CAD-score ≤20

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Safe rule out of approximately 47% of suspected stable Coronary Artery Disease Patients in a very safe and fast way

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Recent studies have shown that as few as 6–10% of patients referred to non-invasive testing suffer from significant CAD. This means that 9 out of 10 patients referred to non- invasive diagnostic procedures do not suffer from significant CAD

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The CADScor can rule out nearly 50% of suspected stable Coronary Artery Disease Patients 

Very cost and time efficient Testing (5 Minutes)

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The CADScor®System reclassifies a large group of intermediate risk patients to low risk

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THE CADScor®System – THE EASY SOLUTION TO BRING DOWN COSTS AND RISKS

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What are the main CADScor®System studies?
In 2015 a study from Winther et al. (Denmark), with 228 patients, led to the approval of the device with algorithm v2 Europe. The study was published in 2016 with a diagnostic performance for 

diagnosing >50% stenosis with 90% sensitivity and 92% NPV (prevalence 28%). Dan-NICAD (Denmark), with 1675 patients, was published in 2017 and was the basis for the evolution of algorithm v2 towards algorithm v3.1 which is performing in the commercial device. The Dan-NICAD population showed a diagnostic performance of 81% sensitivity and 96% NPV for diagnosing >50% stenosis (prevalence 9.3%). 

The combined database population (prevalence 10%) performs with 88.7% sensitivity and 97% NPV. 2016 and 2017 VALIDATE (Germany) were performed to gain data outside the intended population (high-prevalence population) to contribute to the evolution of the algorithm. Currently (mid 2019), Dan-NICAD II is ongoing. 

The CADScor®System Algorithm v3.1 database performance is based on 2245 patients (prevalence 10%). Eight acoustic properties covering four aspects of the heart sound are assessed and subsequently combined with 

clinical risk factors (age, gender, Hypertension), using logistic regression into a CAD-score. 

Examples of the acoustic properties are the amplitude of the fourth heart sound, the characteristics of the systolic and mid-diastolic heart sound and the frequency distribution of the second heart sound. All those sounds have previously described to be predictive of the presence of CAD. 

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How does the Algorithm v3 perform with/without clinical risk factors? 

The Dan-NICAD publication figure 4 illustrates the AUC of the acoustic algorithm version 3 with 62%, whereas the AUC of the “entire” algorithm version 3 (including sound and risk factors) is 

71%. When comparing the acoustic algorithm version 3 and the “entire” algorithm version 3, there is no statistically significant difference for the sensitivity and the NPV. The difference for AUC seen in figure 4 is explained by a lower specificity for the acoustic algorithm version 3 compared to the “entire” algorithm version 3. This means that for the intended exclusion of symptomatic patients with suspected CAD both algorithms perform equally well with respect to NPV and sensitivity. 

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