"Assessing Coronary Artery Blockage with Pulse Waves Alone"... Gangnam Severance Hospital Succeeds in Clinical Validation

Accuracy of Screening for Coronary Artery Disease Confirmed

"Early Identification of High-Risk Groups Expected with Non-Invasive Testing"

The results of a clinical validation study on a domestic medical device that measures pulse waves in the brachial and carotid arteries to assess the risk of coronary artery disease have been released. The device is being evaluated for its potential as an auxiliary screening tool, particularly for patient groups where standard precision testing is difficult, such as the elderly or those with impaired renal function.

A research team that conducted clinical validation of a domestic medical device measuring brachial and carotid artery pulse waves to estimate the risk of coronary artery disease. From left, Byungkwon Lee, Professor of Cardiology at Gangnam Severance Hospital, and Sangseok Lee, Professor of Software Engineering at Sangji University. Gangnam Severance Hospital

On May 14, Gangnam Severance Hospital announced that the research team led by Byungkwon Lee, professor of cardiology at Gangnam Severance Hospital, and Sangseok Lee, professor of software engineering at Sangji University, has published the results of a study evaluating the diagnostic performance of the pulse wave-based medical device "Coronyzer (KH-3000)" for coronary artery disease.

If the coronary arteries become narrowed or blocked, this can lead to angina, myocardial infarction, or sudden cardiac death. To diagnose such conditions, tests such as exercise stress tests, pharmacologic stress tests, coronary CT, and angiography are commonly used. However, these tests are not easily applicable for elderly patients, those who have difficulty exercising, or patients with kidney disease who may be at risk from contrast agents.

The research team validated the potential of a non-invasive testing method that could address these limitations. First, they conducted a prospective study by performing the Coronyzer test on 100 patients suspected of having angina and comparing the results with those of coronary angiography. They then carried out an independent retrospective validation study on 136 patients who had undergone either coronary angiography or coronary CT in real clinical settings.

The evaluation metrics were vascular resistance and compliance. Resistance indicates the degree to which blood flow is impeded, while compliance refers to the elasticity of the blood vessels. The research team considered a resistance above 1.24 or compliance below 0.8 to be warning signs.

In the prospective study, the device demonstrated a sensitivity of 81% and a specificity of 89%. In the retrospective validation, when risk was determined if either of the two criteria was met, sensitivity was 77% and specificity was 41%. When risk required meeting both criteria, sensitivity was 53% and specificity was 78%.

The area under the curve (AUC), which represents overall diagnostic performance, was found to be 0.69. This suggests that the device is more meaningful as a screening or auxiliary diagnostic tool rather than as a confirmatory test.

Byungkwon Lee, who led the study, said, "Patients who are physically weak or unable to undergo standard precision tests due to their health condition can be examined non-invasively and relatively safely. This can help primary care institutions identify high-risk groups for heart disease early and refer them for more precise testing." The study results were recently published in the international journal 'American Journal of Cardiology Plus: Cardiology Research and Practice.'

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