Method for non-invasive diagnosis of hemodynamically significant coronary artery disease based on stress echocardiography

Abstract

FIELD: cardiology.SUBSTANCE: patient undergoes stress echocardiography with physical exercise or pharmacological agents according to an extended protocol. The signs of a pathological response are determined not only by the appearance or worsening of local contractility disorders in 2 or more segments of the left ventricle, but also by the following: a decrease in the levels of contractile reserve of 2.0 or less for physical activity and dobutamine, and 1.1 or less for vasodilators; a decrease in the coronary reserve in the anterior descending coronary artery of 2.0 or less; a decrease in the heart rate reserve of 1.8 or less for physical activity and dobutamine, and 1.22 or less for vasodilators; the appearance of 2 or more B-lines in the lungs. Then, 1 point is assigned to each of the pathological signs, then the sum of the points is determined, and if the sum of the stress echocardiography points is 4 or more, hemodynamically significant coronary artery disease is diagnosed.EFFECT: method allows determining the tactics of patient management, selecting patients for invasive coronary angiography and deciding on myocardial revascularization.1 cl, 1 tbl, 6 ex

Description

[0001] The invention relates to medicine, namely to cardiology, and can be used to diagnose hemodynamically significant coronary artery (CA) lesions based on stress echocardiography in individuals (stress EchoCG) with chest pain and shortness of breath.

[0002] The leading place of cardiovascular pathology in the structure of overall mortality encourages the search for effective non-invasive methods for diagnosing hemodynamically significant coronary artery disease, which make it possible to determine patient management tactics and select individuals for invasive coronary angiography (CAG).

[0003] According to large meta-analyses, the methods for assessing the structure of the coronary arteries (invasive and non-invasive coronary angiography) do not allow for the correct assessment of the hemodynamic significance of coronary stenoses, and currently the "gold" standard for diagnosing hemodynamically significant stenoses is intracoronary determination of the level of fractional flow reserve (FFR) or instantaneous flow reserve (IFR). Various authors in multicenter studies have shown that stenosis of the main coronary artery of 50-70% is hemodynamically insignificant and does not require myocardial revascularization in 2 / 3 of cases, stenosis of 70-90% - in 1 / 3 of cases [1].

[0004] However, routine determination of FFR and MFR is not readily available to most medical institutions in the Russian Federation due to the need for additional medical equipment, expensive disposable sensors, specialized training for physicians in endoscopic surgery departments, and the potential increased risk of complications. Therefore, methods for assessing the hemodynamic significance of coronary artery stenoses in the absence of FFR / MFR assessment have been and continue to be developed.

[0005] A method for assessing the hemodynamic significance of coronary artery stenoses [2] is proposed using a simpler method that does not require additional resources. This is achieved by inserting a balloon under X-ray control into the area of ​​the coronary artery being assessed and inflating it. A contrast agent is then injected into the artery, and its distribution is assessed.

[0006] The disadvantages of this method are the risk of periprocedural complications and invasiveness.

[0007] Certain methods utilize perfusion computed tomography or positron emission tomography (PET) of myocardial perfusion with stress testing to assess the hemodynamic significance of stenoses. These methods allow for the evaluation of coronary artery anatomy, the identification of stenoses, and the assessment of their hemodynamic significance. Echocardiography with additional parameters is used to diagnose hemodynamically significant coronary artery stenoses in patients with perfusion defects, as determined by single-photon emission computed tomography of the myocardium with 99mTc-Technetril [3, 4, 5].

[0008] The disadvantages of all these methods are the need to use expensive equipment and significant radiation exposure to the patient.

[0009] Stress echocardiography has been used for nearly 40 years to verify the severity and extent of myocardial ischemia. For this purpose, local contractility abnormalities (LCA) are identified at the peak of the test [6]. Various methods have been proposed to improve the accuracy of stress echocardiography in diagnosing coronary artery disease (CAD), taking into account additional parameters in addition to LCA.

[0010] A “Method for diagnosing coronary artery disease” [7] is known, which consists of recording the stroke volume of the left ventricle during stress echocardiography with transcranial pressure echocardiography or dobutamine; its dynamics make it possible to predict severe multivessel coronary artery disease.

[0011] The disadvantage of this method is that it requires complex diagnostic procedures that are poorly tolerated by the patient. In addition, complications may arise during the examination, including the need for resuscitation.

[0012] A method for diagnosing coronary heart disease [8] is known based on the assessment of the results of tissue Doppler echocardiography during stress echocardiography.

[0013] Its disadvantage is the borderline values ​​of sensitivity and specificity.

[0014] All these methods do not compare the obtained results with the data on the FFR / MRF values ​​in the corresponding coronary arteries, which is the “gold standard” for assessing the hemodynamic significance of coronary artery stenosis.

[0015] There are no data in the literature on large studies comparing the diagnostic capabilities of stress echocardiography with FFR / MRF. The only meta-analysis including data on three single-center studies with a total of 155 patients who compared standard stress echocardiography (assessing only the occurrence of NLS) and coronary angiography with FFR assessment was published in 2017 [9], whereas in the last 5-7 years, a decrease in the value of negative stress echocardiography results according to the NLS criterion has been observed, which is associated with a change in the clinical phenotype of patients: an increase in the proportion of individuals with comorbidity, multicomponent cardioactive therapy and / or revascularization, earlier referral of patients for specific diagnostics, microvascular angina, and a history of coronavirus infection. Currently, assessing NLS alone is insufficient for assessing the hemodynamic significance of coronary artery stenoses

[10] .

[0016] The multicenter clinical studies Stress Echo 2020 and Stress Echo 2030 in a modern heterogeneous group demonstrated that the assessment of several parameters allows for more accurate phenotype of patients. To increase the sensitivity and negative predictive value of stress echocardiography results, it was proposed to supplement the study protocol with an assessment of coronary reserve (CR) in the anterior descending artery (LDA), heart rate reserve (HR), contractile reserve (CR) of the left ventricle (LV), and B-line counting (ABCDE protocol) as markers that have previously shown independent diagnostic and prognostic value [11,12]. However, these studies did not aim to evaluate the hemodynamic significance of coronary artery stenosis based on the results of the extended stress echocardiography protocol.

[0017] No adequate prototype was found in the analyzed patent and scientific medical literature.

[0018] The objective of the proposed invention is to develop an accurate non-invasive method for diagnosing hemodynamically significant coronary artery disease based on the results of stress echocardiography performed according to an extended protocol in individuals with chest pain or shortness of breath.

[0019] The task is solved based on the results of stress echocardiography performed according to the extended protocol, wherein the signs are determined not only by the appearance or worsening of NLS in 2 or more LV segments, but also by the following: decreased SR levels by 2 or less for physical activity (PE) and dobutamine, and 1.1 or less for vasodilators; decreased CR in LNA by 2 or less; decreased HR reserve by 1.8 or less for PE and dobutamine, and 1.22 or less for vasodilators; appearance of 2 or more B-lines in the lungs, then each of the pathological signs is assigned 1 point, then the sum of the points is determined, and if the sum of the stress echocardiography points is 4 and 5, hemodynamically significant coronary artery disease is diagnosed.

[0020] The novelty of the proposed invention is that it determines the total score of a patient's stress echocardiography using the extended protocol (ABCDE protocol), allowing for the diagnosis of hemodynamically significant coronary artery disease (4 or 5 points). If the total score of the stress echocardiography protocol is 5, the probability of hemodynamically significant coronary artery disease is 100%.

[0021] The new features exhibited new properties in the claimed combination that are not clearly derived from the state of the art in this field and are not obvious to a person skilled in the art. No identical combination of features was found in the patent or scientific medical literature.

[0022] The method proposed as an invention can be used to determine the tactics of patient management: selection of patients for invasive CAG, possible planning of one-stage stenting with appropriate drug preparation of the patient.

[0023] Based on the above, the proposed invention should be considered as meeting the patentability conditions of “Novelty” and “Inventive step”.

[0024] The invention will be clear from the following description.

[0025] The proposed method is based on the results of a clinical study. The prospective observational study includes 454 patients with a confirmed or suspected diagnosis of coronary artery disease. Inclusion criteria: age 18-80 years; indications for stress echocardiography to verify the diagnosis of coronary artery disease and / or restratification of the risk of coronary artery disease in case of a previously established diagnosis of the disease in accordance with clinical guidelines [13,14]. Exclusion criteria: clinical suspicion of vasospastic angina; clinical signs of circulatory failure class IV according to the NYHA classification; absolute contraindications to stress echocardiography; lack of visualization of the endocardium of more than 3 LV segments during echocardiography; neuropsychiatric diseases that hinder contact with a doctor.

[0026] The method is carried out as follows:

[0027] After signing the informed consent (the study was approved by the Biomedical Ethics Committee of the Research Institute of Cardiology of Tomsk National Research Medical Center No. 223 dated January 19, 2022), 454 patients were included in the study (276 (60.79%) men, 276 (39.21%) women, age 61.22±9.80 years, ejection fraction (EF) of the LV 66.84% (63.09-71.58%)), with an established (n=191, 42.07%) or suspected diagnosis of coronary artery disease (n=263, 57.93%), pretest probability of coronary artery disease (PTV IHD) 17.0% (11.0-27.0%)). At the stage of selection for the study, patients' height, weight, body mass index, body surface area, systolic and diastolic blood pressure (BP) and heart rate are assessed; if coronary artery disease is suspected, the PT of the coronary artery disease is determined

[13] ; a 12-lead electrocardiogram is recorded; levels of glucose, total cholesterol, triglycerides, low-density and high-density lipoprotein cholesterol are determined; echocardiography (EchoCG) and ultrasound examination of the carotid arteries are performed.Next, the attending physician, depending on the patient's clinical profile, determines the type of load for stress echocardiography and no later than 24 hours before the study, discontinues medications with an antianginal effect.

[0028] Stress echocardiography with adenosine triphosphate (ATP) (n=85; 18.72%), transesophageal electrical pacing (TEPS) (n=28, 6.16%), dobutamine (n=9, 1.98%) and bicycle ergometry (BEM) on a recumbent ergometer (n=332, 73.12%) are performed on the ultrasound diagnostic systems Vivid 9 (GE Healthcare, USA), Vivid 095 (GE Healthcare, USA) using the matrix sector phased array transducer M5S-D (1.5-4.6 MHz) or Philips Affiniti 70 (Philips, USA) using the sector transducer S4-2 (2-4 MHz). Adenosine triphosphate is administered as an infusion of 140 mcg / kg / min over 6 minutes, followed by atropine at a dose of 1 mg intravenously by jet stream if the test results are negative and there are no contraindications. Transesophageal pacing is performed starting with a heart rate 10% higher than the spontaneous heart rate, followed by a stepwise increase in the rate to 100-120-140 beats / min (submaximal heart rate) every 2 minutes with 1-minute breaks between steps.Dobutamine infusion is administered continuously, increasing the dose every 3 minutes according to a protocol of 5-10-20-40 mcg / kg / min + atropine at 0.25 mg / min up to 1.0 mg. VEM is performed on a recumbent cycle ergometer with the table rotated left by 0-40 degrees, starting with a load of 25 W and continuously increasing by 25 W every 2 minutes.

[0029] At baseline, during intermediate stages of the stress test, at peak stress, and during the recovery period, blood pressure, heart rate, ECG, and video clips of the heart in the apical two-, four-, and five-chamber projections are recorded. At rest and at the peak of the test, global contractility parameters and the occurrence of end-systolic contractility (ESC) are analyzed, and the end-systolic contractility index (ESCII) is calculated. B-lines are recorded before the test and in the early recovery period using a four-point scanning protocol. LV contractility reserve is assessed as the ratio of systolic blood pressure to the end-systolic index of the LV at peak stress and at rest. The coronary blood flow spectrum in the distal LAD is recorded at the end of the rest period, at the first stage of the stress test (for staged protocols), at peak stress, or in the first minute of the EP. Coronary reserve is calculated as the ratio of the hyperemic peak diastolic coronary blood flow velocity to the basal one. HR reserve is estimated as the ratio of HR at peak load / HR at rest [11,12].

[0030] The criteria for a positive test are: the appearance of NLS or aggravation of existing NLS by one or more points in two or more LV segments (NLS+); the presence of B-lines at rest or their appearance under stress ≥2 (B-lines+); the value of LV SR ≤1.1 during the test with vasodilators, ≤2.0 with other stress agents (SR+); a decrease in CR in the LAD ≤2.0 (CR+); the value of HR reserve ≤1.22 during the test with vasodilators, ≤1.8 with other stress agents (HR reserve+). The echocardiography results are categorized for each indicator with a score of 0 in case of a normal value and a score of 1 for a pathological one, and the total number of pathological signs is calculated (the total score of the ABCDE protocol). Accordingly, the minimum possible test score is 0, the maximum is 5.

[0031] Invasive coronary angiography was performed within 7 days after stress echocardiography using the Axiom Artis digital angiographic system (Siemens; Erlangen, Germany) in 337 (74.23%) patients, and multispiral computed tomography was performed using the Discovery NM / CT 570c hybrid computed tomograph (GE Healthcare, USA) in 58 patients (12.78%). In total, coronary artery structure assessment was performed in 395 (87.01%) patients, including invasive assessment of FFR or MFR as indicated [13,14] in 43 (9.47%) patients.

[0032] Coronary lesion is considered hemodynamically significant in the presence of at least one group of signs: 1) stenosis of one or more main coronary arteries of more than 90%; 2) stenosis of the main coronary artery of 50-90% in combination with reduced FFR / MRF ≤0.80 / ≤0.89; 3) stenosis of the main coronary artery of 50-90% in combination with a transient perfusion defect of more than 10% according to the data of a previously performed stress SPECT (if the study is available in the patient); 4) non-obstructive lesion of the main coronary arteries and reduced FFR ≤0.80 and / or CR <2.0 in any coronary artery. The proportion of patients with hemodynamically significant macrovascular and microvascular coronary artery disease was 45.37% (n=206), with hemodynamically insignificant 54.63% (n=248).

[0033] Statistical analysis is performed using Statistica 16.0 (StatSoft, USA), IBM SPSS Statistics 23.0 software packages. Categorical indicators are presented as absolute (n) and relative (in %) frequencies of occurrence, quantitative indicators - as mean values ​​(M) and standard deviations (SD), M ± SD for normally distributed indicators or medians (Me) and interquartile ranges (Q1-Q3), Me (Q1-Q3) - in the absence of a normal distribution of the indicator. To identify possible stress echocardiographic predictors of hemodynamically significant damage, univariate logistic regression analysis is used. The critical value of the significance level when testing hypotheses is p = 0.05.

[0034] The chance of detecting hemodynamically significant coronary artery disease is associated with almost all clinical and instrumental parameters of stress echocardiography: the appearance of NLS, reduced HR reserve, CR, LV SR, and the total score of the ABCDE protocol (Table 1).

[0035] Table 1. Results of univariate regression analysis of predictors of hemodynamically significant coronary artery disease

[0036] Factor χ2 OR (95% CI) r NLS (+) 237,71 40,60 (40,36-40,84) <0,00001 B-lines (+) 0,70 0,400 SR LV (+) 5,61 1,60 (0,98-2,22) 0,018 KR (+) 56,91 8,15 (7,72-8,58) <0,00001 Heart rate reserve (+) 4,86 1,53 (1,83-2,23) 0,028 Score ABCDE 115,40 2,51 (2,39-2,63) <0,0001

[0037] In general, as the number of any positive signs of the stress test increases, the detection rate of hemodynamically significant coronary artery disease increases, such that it is 14.6% with a score of 0, 25% with a score of 1, 38.14% with a score of 2, 69.79% with a score of 3, 81.25% with a score of 4, and 100% with a score of 5. Thus, the sensitivity reaches satisfactory values ​​when the ABCDE protocol score is 4 or higher, and when the score is 5, it reaches 100%.

[0038] Example 1. Patient Yu., 67 years old, coronary artery disease: effort angina, FC 2. PT IHD 11%. Stage 3 hypertension, risk 4. Carotid artery atherosclerosis up to 20%. Non-smoker. Stress echocardiography with ATP 140 mcg / kg / min was performed. At rest, there is no NLS, LVEF 74%. At peak load, there are no complaints, ECG without significant dynamics, no NLS, LVIF 1.0, LVEF 80% (normal), no B-lines at rest and at the peak of the test (B-lines -), LV SR 1.38 (normal), HR 3.13 (normal), HR reserve 1.34 (normal), the total score according to the ABCDE protocol is 0 points. Thus, the overall ABCDE protocol score is 0 points. Based on the proposed method, the patient is diagnosed with no hemodynamically significant coronary artery disease. Myocardial scintigraphy was performed as a second imaging stress test, revealing a transient perfusion defect of less than 5%. Despite these results, the patient was referred for invasive coronary angiography on the recommendation of an arrhythmologist due to the presence of transient sinoatrial block on the ECG.A coronary angiography revealed 25% stenosis of the right anterior coronary artery (LAA) in the proximal third, confirming the absence of hemodynamically significant coronary artery disease. Treatment strategy is optimal drug therapy.

[0039] Example 2. Patient K., 61 years old, coronary artery disease: effort angina, FC 2. PICS (2010). Stenting of the left anterior adenocarcinoma (LAD) (2012). Hypertension stage 3, risk 4. Atherosclerosis of the carotid arteries up to 5%. Smoker. Stress echocardiography with ATP 140 mcg / kg / min was performed. At rest, hypokinesis of the basal and middle posteroseptal segments of the LV, LSTI 1.18, LVEF 70%. There are no complaints at peak stress, the ECG shows isolated ventricular extrasystoles. EchoCG shows motion abnormalities, LVEF 1.18 (normal) (LVEF 64%), 0 B-lines at rest and at the test peak (- B-lines), LV SR 1.15 (normal), HR 2.88 (normal), HR reserve 1.22 (reduced), and a total score according to the ABCDE protocol of 1 point. Thus, the total score according to the ABCDE protocol is 1 point. Based on the method proposed as an invention, the patient is diagnosed with the absence of hemodynamically significant coronary artery disease. Myocardial scintigraphy was performed - the transient myocardial perfusion defect is 9%, taking this into account, the patient was referred for invasive coronary angiography.During coronary angiography (CAG), stenosing atherosclerosis of the coronary arteries was revealed: stenosis of the posterior interventricular branch of the right coronary artery (RCA) was 60% (FRF=0.94); stenosis of the proximal segment of the left anterior atrial artery (LAA) was 30% (FRF=0.91). Thus, FFR confirmed the absence of hemodynamically significant coronary artery disease; the treatment strategy was optimal drug therapy.

[0040] Example 3. Patient M., 62 years old, with coronary artery disease (CAD): effort angina, FC 2. PT of CAD 16%. Stage 3 hypertension, risk 4. Carotid atherosclerosis up to 35%. Type 2 diabetes mellitus. Non-smoker. Stress echocardiography with ATP 140 mcg / kg / min. No NLS at rest, LVEF 78%. No complaints at peak stress, ECG without significant changes. EchoCG shows no pulmonary embolism, LVEF 79% (normal), 1 B-line at rest, 4 B-lines at the test peak (+ B-lines), LV SR 1.15 (normal), HR 1.86 (reduced), HR reserve 1.41 (normal), and a total ABCDE score of 2. Thus, the total ABCDE score is 2. Based on the proposed method, the patient is diagnosed with no hemodynamically significant coronary artery disease. Myocardial scintigraphy was performed—the transient myocardial perfusion defect is 12%. Therefore, the patient was referred for invasive coronary angiography.During coronary angiography (CAG), stenosing atherosclerosis of the coronary arteries was detected: 25% RCA stenosis in the proximal third; 50% LAD stenosis in the proximal third. FFR was determined to be the "gold standard" for hemodynamically significant lesions; it was 0.92, normal. Thus, FFR confirmed the absence of hemodynamically significant coronary artery disease, and the treatment strategy was optimal drug therapy.

[0041] Example 4. Patient K., 48 years old, coronary artery disease: angina, FC 2. PT of coronary artery disease 6%. Hypertension stage 3, risk 4. Atherosclerosis of the carotid arteries up to 45%. History of stenting of the common iliac artery. Smoker. Stress echocardiography with ATP 140 mcg / kg / min was performed. There are no complaints at peak stress, the ECG shows T-wave inversion in V 2-3,Hypokinesis of the posterior interventricular septum, middle posterior LV wall and apical septal segment of the LV, LVIF 1.19 (pathological reaction), appearance of 4 B-lines at the test peak (B-lines +), LV SR 1.41 (normal), HR 2.0 (reduced), HR reserve 1.26 (normal), total score according to the ABCDE protocol 3 points. Thus, the total score according to the ABCDE protocol is 3 points - based on the method proposed as an invention, the patient is diagnosed with the absence of hemodynamically significant coronary artery disease. During coronary angiography - intact coronary arteries, the absence of hemodynamically significant coronary artery disease is confirmed. Treatment tactics - optimal drug therapy.

[0042] Example 5. Patient H., 69 years old, with coronary artery disease (CAD): effort angina, FC 1. PT of CAD 44%. Stage 3 hypertension, risk 4. Carotid atherosclerosis up to 40%. Non-smoker. Stress echocardiography with PE in a supine position was performed. No NLS at rest, LVEF 58%. A 100 W load was performed for 1 min, with the following criteria for stopping the load: shortness of breath and muscle weakness. The patient did not report chest pain, and the ECG showed no significant changes. EchoCG revealed no hemodynamically significant coronary artery disease, LVEF 1.0 (normal) (LVEF 59%), 3 B-lines at rest, 5 B-lines at the test peak (+ B-lines), LV SR 1.55 (decreased), HR 1.69 (decreased), HR reserve 1.67 (decreased), and a total ABCDE score of 4. Thus, the total ABCDE score is 4. Based on the inventive method, the patient is diagnosed with hemodynamically significant coronary artery disease. The patient was referred for invasive coronary angiography with preliminary preparation for possible simultaneous stenting.During coronary angiography (CAG) there was stenosing atherosclerosis of the coronary arteries: stenosis of the middle segment of the left coronary artery 75% (IRC = 0.85); stenosis of the first interstitial stent 75% (IRC = 0.88). Using FFR, the presence of hemodynamically significant coronary artery disease (stenosis of the left coronary artery and the first interstitial stent) was confirmed. Considering the presence of hemodynamically significant stenoses according to the CAG data, the presence of angina pectoris clinical picture, stress echocardiography data, the absence of stenoses of the left coronary artery trunk, the proximal segment of the left coronary artery, and diabetes mellitus, as well as a low Syntax score, a decision was made to perform simultaneous two-vessel stenting. Balloon dilation (BD) and stenting with the Biomime 3 x 44 mm stent of the middle segment of the left coronary artery were performed. BD and stenting with the XIENCE Alpine stent - 3 x 18 mm of the first interstitial stent were performed.

[0043] Example 6. Patient L., 60 years old, coronary artery disease: effort angina, FC 2. PT of coronary artery disease 44%. Stage 3 hypertension, risk 4. Atherosclerosis of the carotid arteries up to 30%. Non-smoker. Stress echocardiography with EF was performed in a supine position. At rest, hypokinesis of the basal and middle segments of the posterior wall of the LV, LSIF 1.125, LVEF 60%. A load of 50 W was performed for 1 min 30 sec, the criterion for stopping the load is aggravation of LSIF. At the peak of the load, pressing pain behind the sternum, the ECG shows frequent supraventricular extrasystoles, including paired ones. EchoCG reveals hypokinesis of the middle sections of the lateral and anterior walls of the LV, LVIF 1.31 (pathological reaction) (LVEF 62%), 3 B-lines at rest, 9 B-lines at the test peak (B-lines +), LV SR 1.2 (decreased), HR 1.29 (decreased), HR reserve 1.51 (decreased), total score according to the ABCDE protocol 5 points. Thus, the total score according to the ABCDE protocol is 5 points - based on the method proposed as an invention, the patient is diagnosed with hemodynamically significant coronary artery disease, its probability is 100%.The patient was referred for invasive coronary angiography with preliminary preparation for possible simultaneous stenting. During coronary angiography, there was stenosing atherosclerosis of the coronary arteries: stenosis of the posterior interventricular branch of the RCA 70% (IRC=0.84); stenosis of the middle segment of the LAD 65% (IRC=0.86); stenosis of the first diagonal branch 70% (IRC=0.78); stenosis of the proximal segment of the OA 65% (IRC=0.82); stenosis of the first posterior tricuspid branch 75% (IRC=0.82). FFR confirmed the presence of hemodynamically significant lesion of the posterior interventricular branch of the RCA, middle segment of the LAD, first diagonal branch, proximal segment of the OA; first posterior tricuspid branch 75%. Given the presence of hemodynamically significant stenoses based on magnetic resonance imaging (MRI), clinical angina, stress echocardiography data, the absence of stenosis of the left main coronary artery (LMCA), the absence of proximal LAD stenoses, and diabetes mellitus, as well as a low Syntax score, a decision was made to perform simultaneous multivessel stenting. A BD was performed, and stenting was performed using a 3 x 36 mm Cruz stent in the mid-LAD ​​segment. The MRI result after stent placement was 0.95.We performed BD of the middle segment of the LAD - 1st diagonal branch. The MRC result after BD = 0.94. We performed BD and stenting with the XIENCE Alpine stent (SES) - 3 x 28 mm of the proximal OA segment. The MRC result after the stent = 0.99. We performed BD and stenting with the XIENCE Alpine stent (SES) - 3 x 15 mm of the first VTC. The MRC result after the stent = 0.99. Recommended: a follow-up examination in 6 months (or earlier - if clinical manifestations of angina) to determine the indications for selective coronary angiography with possible stenting of the stenotic segment of the posterior interventricular venous system.

[0044] Thus, our invention is based on the use of a non-invasive diagnostic method—stress echocardiography—that is low-cost, highly reproducible, and does not involve radiation exposure to the patient. Compared to existing methods, the proposed method allows for a simple and accurate determination of the hemodynamic significance of coronary artery stenosis, the determination of patient management strategies, and the selection of patients for invasive coronary angiography (CAG) with the consideration of myocardial revascularization, including the planning of simultaneous coronary artery stenting with appropriate preparation.

[0045] The method proposed as an invention has been tested on 454 patients and allows for the highly accurate determination of the presence of hemodynamically significant stenosis in patients with chest pain or shortness of breath.

[0046] SOURCES OF INFORMATION

[0047] 1. Knuuti J., Ballo H., Juarez-Orozco LE, Saraste A., Kolh P., Rutjes AWS, et al. The performance of non-invasive tests to rule-in and rule-out significant coronary artery stenosis in patients with stable angina: a meta-analysis focused on post-test disease probability. Eur Heart J 2018;39(35):3322-3330. https: / / doi.org / 10.1093 / eurheartj / ehy267

[0048] 2. Patent No. 2622615 Russian Federation, IPC: A61B6 / 00 "Method for assessing the hemodynamic significance of coronary artery stenosis" [Text] / Khubutia M.Sh., Chestukhin V.V., Mironkov A.B., Parkhomenko M.V., Goncharov S.P. applicant and patent holder: "State Budgetary Institution of Moscow, N.V. Sklifosovsky Research Institute of Emergency Care (RU) - 2016129728 declared 20.07.2016; published 16.06.2017, Bulletin No. 17.

[0049] 3. Patent No. 2748527 Russian Federation, IPC: A61B6 / 00 "Method for detecting coronary heart disease and microvascular dysfunction in patients with suspected acute coronary syndrome" [Text] / Omarov Yu.A., Shakhnovich R.M., Veselova T.N., Sukhinina T.S., Staroverov I.I., Ternovoy S.K. applicant and patent holder: Federal State Budgetary Institution "National Medical Research Center of Cardiology" (RU) - 2020118433 declared 04.06.2020; published 66.05.2021, Bulletin No. 15.

[0050] 4. Patent. No. 2518536 Russian Federation, IPC: A61B8 / 06 "Method for diagnosing significant coronary stenoses in patients with myocardial perfusion disorders based on single-photon emission computed tomography of the myocardium with 99m Tc-technetrile" [Text] / Kuznetsov V.A., Yaroslavskaya E.I., Gorbatenko E.A., Krinochkin D.V., Geffenberg D.V. applicant and patent holder: Federal State Budgetary Institution "Research Institute of Cardiology of the Siberian Branch of the Russian Academy of Medical Sciences" (RU) - 2013107829 declared 21.02.2013; published 10.06.2014, Bulletin No. 16.

[0051] 5. Patent No. 2406443 Russian Federation, IPC: A61B5 / 02 "Method for diagnosing hemodynamically significant atherosclerosis of the coronary arteries" [Text] / applicants and patent holders: Federal State Institution "Russian Research Center of Radiology and Surgical Technologies" (RU); Federal State Institution "V.A. Almazov Federal Center of Heart, Blood and Endocrinology" (RU) - 2009115110 declared 20.04.2009; published 10.12.2010, Bulletin No. 35.

[0052] 6. Sicari R., Pasanisi E., Venneri L., Landi P., Cortigiani L., Picano E. Stress echo results predict mortality: a large-scale multicenter prospective international study. J Am Coll Cardiol 2003;41:589-95. doi: 10.1016 / s0735-1097(02)02863-2.

[0053] 7. Patent No. 2180520 Russian Federation, IPC: A61B8 / 06 "Method for diagnosing coronary artery disease" [Text] / Shlyakhto E.V., Nifontov E.M., Rudomanov O.G., Kazarin V.V. applicant and patent holder: "St. Petersburg State Medical University named after Academician I.P. Pavlov (RU) - 2000133379 declared. 29.12.2000; published. 20.03.2002, Bulletin No. 8.

[0054] 8. Patent. No. 2182464 Russian Federation, IPC: A61B8 / 06 "Method for diagnosing ischemic heart disease" [Text] / Titenkov I.V., Makhnov A.P., Shabrov A.V., Titova I.Yu. applicant and patent holder: Federal State Budgetary Institution "Saint Petersburg State Medical Academy" (RU) - 2000114397 declared. 05.06.2000; published. 20.05.2002, Bulletin No. 14.

[0055] 9.Danad I., Szymonifka J., Twisk J.W.R., Norgaard B.L., Zarins C.K., Knaapen P., et al. Diagnostic performance of cardiac imaging methods to diagnose ischaemia-causing coronary artery disease when directly compared with fractional flow reserve as a reference standard: a meta-analysis. Eur Heart J. 2017;38(13):991-998. https: / / doi.org / 10.1093 / eurheartj / ehw095.

[0056] 10. Picano E., Pierard L., Peteiro J., Djordjevic-Dikic A., Sade L.E., Cortigiani L., et al. The clinical use of stress echocardiography in chronic coronary syndromes and beyond coronary artery disease: a clinical consensus statement from the European Association of Cardiovascular Imaging of the ESC. Eur Heart J Cardiovasc Imaging. 2024;25(2):e65-e90. doi: 10.1093 / ehjci / jead250.

[0057] 11. Ciampi Q., ​​Zagatina A., Cortigiani L., Wierzbowska-Drabik K., Kasprzak JD, Naberka M., et al. Prognostic value of stress echocardiography assessed by the ABCDE protocol. Eur Heart J 2021;1;42(37):3869-3878. doi: 10.1093 / eurheartj / ehab493. PMID: 34449837; PMCID: PMC8486488.

[0058] 12. Gaibazzi N., Ciampi Q., ​​Cortigiani L., Wierzbowska-Drabik K., Zagatina A., Djordjevic-Dikic A., et al. Multiple Phenotypes of Chronic Coronary Syndromes Identified by ABCDE Stress Echocardiography. Journal of the American Society of Echocardiography. 2024;37(5):477-85. DOI: 10.1016 / j.echo.2023.12.003.

[0059] 13. Barbarash O.L., Karpov Yu. A., Panov A. V., Akchurin R. S., Alekyan B. G., Alekhine M. N., et al. Stable coronary artery disease. Clinical guidelines 2024. Russian journal of cardiology. 2024;29(9):6110. doi: 10.15829 / 1560-4071-2024-6110.

[0060] 14. Vrints C., Andreotti F., Koskinas K.C., Rossello X., Adamo M., Ainslie J., et al. ESC Scientific Document Group, 2024 ESC Guidelines for the management of chronic coronary syndromes: Developed by the task force for the management of chronic coronary syndromes of the European Society of Cardiology. Eur Heart J. 2024;45(36):3415-3537. doi:10.1093 / eurheartj / ehae177.