On August 2, NMPA approved the registration application for the "Coronary Artery CT Blood Flow Reserve Score Calculation Software" produced by Beijing Xin Century Medical Technology Co., Ltd. for the assisted diagnosis of coronary heart disease. Sale.

Relevant information shows that CT-FFR consists of a software installation CD. The functional modules include: coronary artery extraction module, image cutting module, FFR display module, hemodynamic calculation FFR module. The corresponding process is to perform three-dimensional reconstruction of the coronary vascular tree on coronary CT angiography (CCTA) images. After the coronary artery is segmented, it is calculated based on finite element analysis and fluid dynamics simulation simulation, and finally the CT blood flow reserve for each position of the target blood vessel is calculated Fraction. It is mainly used to assist and train qualified medical technicians to assess the symptoms of functional myocardial ischemia in patients with stable coronary heart disease before performing coronary angiography.

Heart CT-anatomical model and physiological model-FFR intelligent calculation-FFR value

Generally speaking, the diagnosis process of coronary heart disease is to do CT first, and then do coronary angiography. When the degree of vascular stenosis is clinically diagnosed to exceed 70%, stent therapy is required.

Although coronary angiography (CAG) is considered to be the "gold standard" for the diagnosis of coronary heart disease and is a more reliable invasive diagnostic technique, it can only perform imaging evaluation of the degree of coronary artery disease stenosis and cannot determine whether the patient exists Functional ischemia. Past data shows that in cases of stent treatment after CAG, nearly half of the patients do not need stent treatment.

According to previous media reports, patients can directly perform CT-FFR software analysis after undergoing a CT examination. The obtained FFR values can not only assess the degree of stenosis of the diseased blood vessel from the anatomical structure, but also from the hemodynamics. The angle reflects the degree of myocardial perfusion/ischemia. "If the value is less than 0.8, further angiography and stent therapy are recommended; if it is greater than 0.8, conservative treatment is sufficient."

Another way to diagnose coronary heart disease is invasive FFR measurement. In contrast, traditional FFR examination requires the injection of adenosine or ATP into the human body to induce maximum expansion of the microcirculation. The side effects of the drugs limit the FFR of some patients. The application increases the operation steps, prolongs the operation time, and easily causes postoperative complications.

The above two methods are invasive, with expensive detection equipment and high operational requirements. At present, they have not yet been widely used in clinical practice. Only a few top three hospitals can perform FFR diagnosis.

In addition, it is understood that the current domestic FFR operation in China is about 15,000 to 20,000 yuan, and the cost of using CT-FFR is less than one-tenth of the operation.