RU2789429C1 - A method for diagnosing heart failure with preserved left ventricular ejection fraction in patients with coronary artery disease on the background of non-occlusive atherosclerosis of the coronary arteries - Google Patents

Abstract

FIELD: health care.

SUBSTANCE: invention relates to medicine, namely to cardiology and radiation diagnostics, and can be used to diagnose heart failure with a preserved left ventricular ejection fraction in patients with coronary heart disease against the background of non-occlusive atherosclerosis of the coronary arteries. The global reserve of coronary blood flow is determined using dynamic single-photon emission computed tomography of the myocardium. At a value of 2.27 or less, chronic heart failure with a preserved left ventricular ejection fraction is diagnosed.

EFFECT: method enables to predict a chronic heart failure in patients with coronary artery disease against the background of non-occlusive atherosclerosis of the coronary arteries at the preclinical stage of development, which makes it possible to identify a priority group of patients with an increased risk of cardiovascular complications for dispensary observation and the appointment of personalized treatment, by determining the global reserve of coronary blood flow.

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Description

The invention relates to medicine and can be used in cardiology, therapy, rehabilitology, radiation diagnostics to improve the quality of early preclinical diagnosis of chronic heart failure with a stored ejection fraction (SNSF) in patients with coronary heart disease (coronary heart disease) amid non -complicating atherosclerosis Coronary arteries to analyze the magnitude of the global reserve of coronary blood flow (GRCK).

Heart failure with a preserved ejection fraction (SNSFV) is becoming an increasingly common form of chronic heart failure (CHF), the rate of occurrence of which over the past 10 years has increased on an average of 10-20% relative to the similar indicator with a reduced emission faction [1] , and does not have evidence -based therapy, which is largely due to the lack of a single view on the mechanisms of the formation of this pathology [2, 3, 4].

Recently, the subject of discussion is the clinical significance of non-obstructive CAD in the development of adverse cardiovascular events and the course of CHF with preserved LV EF [5]. In such patients, the end point of the “cardiovascular continuum” is most often CHF with preserved and intermediate LV EF [6], and it is these patients who are most often hospitalized in hospitals with decompensated heart failure [7]. It has been documented that the treatment of patients with non-obstructive CAD is the most expensive, which is mainly associated with frequent hospitalizations for the progression of angina and heart failure [2].

Patients with non-obstructive coronary artery disease, despite preserved LV EF, are more prone to hospitalization due to decompensated heart failure [7], however, the mechanisms responsible for the progression of HFrEF against the background of non-obstructive coronary atherosclerosis are not fully understood [2, 7, 8]. Diagnosis of CHF, especially in the early stages, not to mention HFpEF, can cause certain difficulties [9]. If CHF is suspected, echocardiography is the method of choice due to its ubiquity, safety, and relatively low cost [9], but this method has a number of disadvantages: low spatial resolution [10], interobserver variability [11]. NT-proBNP testing is recommended to rule out or confirm the diagnosis of heart failure, which helps establish an initial working diagnosis by identifying those who need further cardiac evaluation [12], but current research suggests that NT-proBNP can only be used for exclusion of HFpEF, but not for its diagnosis. It is also important that the determination of the level of NT-proBNP is recommended in patients with unclear signs and symptoms, therefore, there is no reason to apply this recommendation for preclinical diagnosis of CHF, when there are no symptoms and signs yet.

The initial link in the manifestation and development of HFpEF, even in the absence of stenosing atherosclerotic lesions of the coronary vessels and the appearance of symptoms and signs of CHF, is a violation of the coronary blood supply at the level of microcirculation; at the same time, the severity of changes in myocardial blood flow at rest and coronary reserve are closely related to the severity of CHF [13, 14]. Few studies indicate that incipient pathological changes in the homeostasis of the coronary blood supply can be judged by a decrease in the reserve of coronary blood flow, quantified by single photon emission computed tomography [15, 16, 17].

A known method for non-invasive quantitative determination of myocardial blood flow to detect coronary insufficiency [18]. The disadvantage of this method is that: 1) it uses a different research protocol with a single injection of a radiopharmaceutical ^99m Tc-methoxy-isobutyl-isonitrile ( ^99m Tc-MIBI) of greater activity - 555.0 MBq; 2) the method is used to diagnose myocardial ischemia (CHD), but not to verify the most common complication of most cardiovascular diseases - chronic heart failure with preserved ejection fraction.

On the contrary, with the proposed method, a lower dosage ^{of 99m} Tc-MIBI - 260-444 MBq is introduced as part of the two-day "rest-load" protocol, which reduces the radiation exposure to the patient, and the use of this method allows diagnosing CHF at an early, preclinical stage of its development due to Determining the global reserve of coronary blood flow.

In the analyzed patent and scientific medical literature, an adequate prototype was not found.

The objective of the invention is to create a method that improves the quality of early preclinical diagnosis of chronic heart failure with preserved left ventricular ejection fraction in patients with coronary heart disease (CHD) against the background of non-occlusive atherosclerosis of the coronary arteries by analyzing the magnitude of the global reserve of coronary blood flow (GRKK).

The task is solved by determining the global reserve of coronary blood flow when performing dynamic single -photon emission computed tomography (DOFECT) of myocardium according to the formula: timing = KC load/ KC POSURE, where CC load is the value of coronary blood flow against the background of a pharmacological stress test, (ml/ min/ min/ min/ min. G); KC peace - the value of coronary blood flow in conditions of rest, (ml/min/g). When the value of the GRMK is equal to and less than 2.27, chronic heart failure is diagnosed with preserved ejection fraction of the left ventricle.

The proposed method is based on the fact that the dilatation capacity of the coronary microcirculatory channel or the reserve of coronary blood flow (RSC), which reflects the effect of the general resistance of the coronary arteries and the vasodilative ability of the microcirculatory channel, changes with most cardiovascular diseases (obstructive IBS, arterial hypertension, diabetes, etc. .) [19, 20], which can act as triggers in a change in the metabolic of the heart, activation of the neurogumoral system and non -specific inflammation, potentiating, in turn, the development of endothelial dysfunction and a decrease in blood flow [19]. These changes in the complex before the appearance of symptoms and signs of heart failure lead to dysfunction of the mitochondria of cardiomyocytes, their hypertrophy and apoptosis, increase myocardial rigidity and fibrosis, followed by the development of diastolic dysfunction, myocardial remodeling and the manifestation of SNSFV.

Thus, the change in the global reserve of coronary blood flow during myocardial dSPECT may be an early criterion for diagnosing HFpEF in patients with non-occlusive coronary atherosclerosis, the growth rate of which has increased by an average of 10-20% over the past decade, leading to deaths annually from 1.3 to 17.5% of the population [1].

The advantage of the proposed invention is that the method allows:

- to diagnose the most common complication of most cardiovascular diseases even at the preclinical stage of HFpEF development and prescribe the appropriate optimal individualized therapy aimed at restoring coronary blood flow and myocardial metabolism;

- identify a priority group of patients with an increased risk of developing HFpEF for dispensary observation and optimization of targeted preventive measures aimed at preventing exceptionally high premature mortality of the population;

- to reduce the large financial costs of health care associated with expensive treatment of a widespread pathology of the working-age population of the state.

Significant features showed in the claimed combination of new properties that do not explicitly follow from the prior art in this field and are not obvious to a specialist. There were no identical set of signs in the analyzed literature. The proposed invention can be used in healthcare.

Based on the foregoing, the invention should be considered as meeting the conditions of patentability “Novelty”, “Inventive step”, “Industrial applicability”.

The invention will be clear from the next description and the attached three figures.

In FIG. 1 presents the results of ROC analysis. It depicts a roc -feces characteristics of the sensitivity and specificity of the global reserve of coronary blood flow (GRCC) for diagnosing heart failure with a preserved fraction of the release (SNSFV) of LV in patients with non -constructive CPS: according to the order axis - the frequency (%) of truly positive results (sensitivity), along the axis of the axis, along the axis of the axis The abscissa is the frequency (%) of false positive results (100 minus specificity). According to the analysis, it follows that the “cut -off point” is Cut OFF, which characterizes the presence of SNSFV with the sensitivity of this criterion of 60.7% with a specificity of 85.7%, is an indicator of the GRCC equal and less than 2.27 (AUC = 0.711; p = 0, 01).

In FIG. Figure 2 shows an example of a dynamic SPET patient U. with non-stenosing atherosclerosis of the coronary arteries: LCA trunk - 30%; proximal segment of the ANA - 40%; middle segment PNA - 20%; OA - 20%; VTK - 25%; proximal RCA segment - 30%; middle segment - 25%. It is illustrated that the global reserve of coronary blood flow exceeds the value of 2.27 and is 2.50. There were no signs of heart failure: NT-proBNP - 117.2 pg/ml (reference level - less than 125 pg/ml).

In FIG. Figure 3 shows an example of a dynamic SPET patient Zh. with non-stenotic atherosclerosis of the coronary arteries: LCA trunk - 20%; muscle bridge in the middle segment of the PNA; proximal RCA segment - 15%. It is illustrated that the global reserve of coronary blood flow is 1.36, which is less than the value of 2.27. NT-proBNP - 169.7 pg / ml (reference level - less than 125 pg / ml), which confirms that the patient has heart failure.

The method is carried out as follows:

Studies are performed in the morning, on an empty stomach, according to a two-day "rest-load" protocol. Preparation for the study includes the abolition of beta-blockers, nitrates, calcium channel antagonists 24 hours before, methylxanthine derivatives (tea, coffee, chocolate) 24 hours before the pharmacological test.

On the first day, research is carried out into a state of functional rest. The patient is placed supine under the gamma camera detector, with the left hand behind the head. A peripheral intravenous catheter is installed in the patient’s right hand. For accurate positioning of the left ventricle in the center of the field of view of the detectors, a non-contrast computed tomography of the heart area is performed (radiation exposure 0.25 mSv). Then begin to record a scintigraphic study. After 5 s, ^99m Tc-MIBI (methoxy-isobutyl-isonitrile) is injected through the catheter at a dose of 260-444 MBq in a volume of 5 ml at a rate of 1 ml/s, directly, after which NaCl solution 0.9% is injected in a volume of 30 ml at a rate of 2 ml/s. Registration of scintigraphic images is carried out for 10 minutes in tomographic ECG-synchronized mode (16 frames per cardiac cycle). The total duration of the study (with the styling of the patient) is 20 minutes. After 60 minutes, a standard ECG-synchronized myocardial perfusion scintigraphy (PSM) is performed.

On the second day, a study is carried out under the conditions of a stress test (pharmacological stress test). The patient is placed supine under the gamma camera detector, with the left hand behind the head. One peripheral intravenous catheter is installed in the right and left hands of the patient. For accurate positioning of the left ventricle in the center of the field of view of the detectors, a non-contrast computed tomography of the heart area is performed (radiation exposure 0.25 mSv). To perform the study, the stress agent adenosine triphosphate (ATP) is used, which is injected intravenously into the left arm using an infusion pump at a dosage of 160 μg/kg/min for four minutes. At the second minute, recording of scintigraphic images is started and a bolus of ^99m Tc-MIBI is injected into the catheter in the right arm at a dose of 260-444 MBq in a volume of 5 ml at a rate of 1 ml/s, after which NaCl solution 0.9% is injected in a volume of 30 ml with at a rate of 2 ml/s. The study is carried out under the control of heart rate, blood pressure, electrocardiogram. Registration of scintigraphic images is carried out for 10 minutes in tomographic ECG-synchronized mode (16 frames per cardiac cycle). The total duration of the study (with the styling of the patient) is 20 minutes. After 60 minutes, a standard ECG-synchronized PSM is performed.

Standard PSM is performed with the patient lying on his back, left hand behind his head. The recording time is 10 minutes in tomographic ECG-synchronized mode (16 frames per cardiac cycle). Motion correction and Attenuation correction are used to eliminate artefacts from correction of cardiac muscle movement and absorption of radiation by soft tissues. The total effective radiation exposure of the study (rest + pharmacological stress test) ranges from 4.4 to 7.5 mSv.

All studies are performed on a Discovery NM/CT 570c hybrid computed tomograph (GE Healthcare, Milwaukee, WI, USA) equipped with a gamma camera with highly sensitive semiconductor cadmium-zinc-tellurium detectors (Cadmium-Zinc-Telluride, CZT). Scintigraphic images are recorded using a low-energy multi-pinhole collimator in 19 projections into a 32×32 pixel matrix (2.46×2.46 mm). The center of the energy window is installed on the photopick ^99M TC 140 KEV; The width of the energy window is symmetrical and is 20%.

The obtained scintigraphic images are processed on a specialized workstation Xeleris II (GE Healthcare, Haifa, Israel). Assessment of myocardial perfusion, blood flow and reserve is carried out using specialized software Corridor 4DM SPECT and 4DM Reserve v.2015 (INVIA, Ann Arbor, MI, USA).

According to the dynamic single-photon emission of myocardial computed tomography, the values of coronary blood flow are determined against the background of pharmacological stress tests and under rest, and then determine the global reserve of coronary bleeding (as the ratio of blood flow to rest on the bloodstream at the load.

The calculation of the global reserve of coronary blood flow is performed according to the formula:

GRKK = MK load/MK peace,

where MC load is the value of myocardial blood flow against the background of a pharmacological stress test, (ml/min/g); MK Peace - the value of myocardial blood flow in conditions of rest, (ml/min/g).

A total of 47 patients (68.7% men) aged 65.0 (58.0; 72.0) years with preserved left ventricular ejection fraction 62 (56; 67)% and non-obstructive coronary artery disease were examined. All studies were performed with the informed consent of the patients and complied with the ethical standards of the Declaration of Helsinki (2000). The study protocol was approved by the Local Ethics Committee of the Research Institute of Cardiology, Tomsk Research Center of the Russian Academy of Sciences (Minutes No. 93 of the meeting of the Biomedical Ethics Committee dated May 25, 2012). A specially developed clinical card was filled for each patient. The concentration of NT-proBNP was determined by enzyme-linked immunosorbent assay (ELISA) using the Biomedica kit (Austria).

According to the guidelines for acute and chronic heart failure, circulating levels of NT-proBNP are used as one of the criteria for diagnosing HFpEF with a threshold value of ≥125 pg/mL [21]. Therefore, depending on the levels of NT-proBNP, patients were divided into 2 groups (p<0.001): group 1 included (n=15) patients with NT-proBNP levels <125 pg/ml (58.2 [41.6; 70 .7] pg/ml), group 2 (n=32) - with overexpression of NT-proBNP ≥125 pg/ml (511.4 [249.8; 1578.1] pg/ml). The main clinical and demographic characteristics of the groups did not differ (Table 1), with the exception of the distance of the 6-minute walk test, which was significantly lower in the group with NT-proBNP levels ≥125pg/ml, and the levels of C-reactive protein, which were higher by 42.6% in group 2 than in group 1.

Table 1 - clinical and demographic characteristics of the examined patients Parameter Group 1, n=15
NT-proBNP <125 pg/ml Group 2. n=32
NT-proBNP ≥125pg/ml P-Value Age, years 56.5 (51.0; 62.0) 62.0 (60.0; 67.0) 0.124 BMI, kg/sq.m. 31.2 (31; 32.0) 30.1 (27.7; 32.0) 0.250 Paul (m/w), abs. (%) 11 (73.3)/4 (26.7) 11 (34.4)/ 21 (65.6) 0.597 TShh, m 600 (590; 680) 400 (350; 480) <0.001 GB, Abs. (%) 15 (100.0) 32 (100.0) 1,000 NTG, Abs. (%) 3 (20.0) 7 (21.9) 0.841 Type 2 diabetes, abs. (%) 4 (26.7) 8 (25.0) 0.912 Smoking, abs (%) 5 (33.3) 11 (34.4) 0.751 NT-proBNP, pg/ml 58.2 (41.6; 70.7) 511.4 (249.8; 1578.1) <0.001 LV EF, % 64 (62; 66) 65 (63; 66) 0.547 LV EDV, ml 107 (98; 119) 112.5 (104.5; 121.5) 0.717 LV CVD, ml 37 (33; 40) 38.5 (34.0; 43.0) 0.547 Notes. NT-proBNP, brain natriuretic peptide precursor; GB - hypertension; BMI - body mass index; IGT - impaired glucose tolerance; DM - diabetes mellitus; TShH - six-minute walk test; LV EF - left ventricular ejection fraction; EDV LV - end diastolic volume of the left ventricle; LV EDV - end systolic volume of the left ventricle.

Statistical processing of the results was carried out using the SPSS 11.5 for Windows application package. The critical level of significance in testing statistical hypotheses in this study was taken equal to 0.05. The description of qualitative data was carried out by constructing contingency tables indicating the absolute and relative frequencies of occurrence of signs. The significance of intergroup differences was assessed using the χ2 criterion.

In group 2, the value of the global reserve of coronary blood flow was 2.19 (1.50; 2.76) and was less by 14.7% (p = 0.001) than in group 1 - 2.68 (2.50; 3, 05). Myocardial blood flow at rest in group 2 exceeded (p = 0.0001) by 33.8%than in group 1 (0.66 [0.46; 0.80] vs. 0.42 [0.30; 0 , 56] ml/min/g, respectively), while myocardial blood flow during the load did not differ between groups (table 2). Differences between the groups in terms of semi-quantitative indicators of standard myocardial perfusion scintigraphy could not be identified.

Table 2. The parameters of the reserve of coronary blood flow and myocardial blood flow depending on the level of NT-PROBNP Name Group 1, n=15
NT-proBNP <125 pg/ml Group 2, n=32
NT-proBNP ≥125pg/ml p-value stress-MBF, ml/min/g 1.37 (1.01; 1.57) 1.41 (1.04; 1.78) 0.18 rest-MBF, ml/min/g 0.42 (0.30; 0.56) 0.66 (0.46; 0.80) 0.0001 gCFR 2.68 (2.50; 3.05) 2.19 (1.50; 2.76) 0.001 SSS 3 (0; 5) 2 (1; 4) 1.0 SRS 0 (0; 1) 0 (0; 2) 0.65 SDS 2.5 (0; 4) 2 (0; 3) 0.96 Note. NT-proBNP, brain natriuretic peptide precursor; Stress Myocardial Blood Flow (stress-MBF) - myocardial blood flow during exercise, Rest Myocardial Blood Flow (rest-MBF) - myocardial blood flow at rest, gCFR - global coronary blood flow reserve; standard semi-quantitative indices of myocardial perfusion disorders: SDS - difference between exercise and rest; SSS - sum of points under load; SRS is the sum of scores at rest.

When analyzing the data, it was found that the value of the global CFR ≤ 2.27 was defined as the threshold value for the diagnosis of HFpEF in patients with non-obstructive CAD with a high degree of probability (sensitivity - 60.7%, specificity - 85.7%; AUC = 0.711; p =0.01) to diagnose the presence of heart failure with preserved ejection fraction.

Example 1: Patient U., male, 42 years old

Complaints about a feeling of discomfort in the region of the heart during significant physical exertion - lifting above the 7th floor, walking in a straight line for more than 1.5-2 km, stop at rest. She takes cardiomagnyl 75 mg/day, atorvastatin 40 mg/day, prestarium 5 mg/day. BMI 29 kg / m ² . The experience of arterial hypertension is 2 years, coronary heart disease - 3 months.

Objective examination: pulse 75 beats/min. BP 110/60 mm Hg. Art., respiratory rate 14 per minute, no edema.

ECG: sinus rhythm, no changes detected.

TSHH 580 m.

EchoCG: EF - 66%; KDO - 119 ml; KSO - 40 ml; The cavities are not enlarged, there is no hypertrophy of the chambers. General contractility is normal, no violation of local contractility was detected. Type 1 diastolic dysfunction. Valves unchanged.

MSCT-KAG: balanced type, narrowing of the LCA trunk -30%; proximal segment of the PNA - 40%; middle segment PNA - 20%; middle segment OA - 20%; the middle segment of the VTK - 25%; proximal RCA segment - 30%; middle segment - 25%.

According to dynamic myocardial SPECT data, the global reserve of coronary blood flow was 2.50 (Fig. 2).

NT-proBNP - 117.2 pg/ml (reference level < 125 pg/ml)

Diagnosis: coronary artery disease: angina pectoris FC I. Background: hypertension stage 3, achieved target blood pressure. Risk 4. FC CHF 0 (NYHA).

Thus, in patient U., who does not have symptoms and signs of CHF during optimal drug therapy, against the background of non-occlusive coronary atherosclerosis, according to myocardial dSPECT, the value of the global reserve of coronary blood flow turned out to be more than 2.27, which made it possible to conclude that this patient does not have HFpEF. The NT-proBNP level confirms the absence of HFpEF.

Example 2: Patient J., female, 51 years old.

Complaints of compressive pain in the precordial region when climbing 3 floors, with emotional stress about 1 time / week, is stopped by validol for 2-3 minutes. He takes cardiomagnyl 75 mg/day, rosuvastatin 20 mg/day, bisoprolol 5 mg/day. BMI 32 kg / m ² . The experience of arterial hypertension is 12 years, coronary heart disease - 2 years. Menopause 7 years.

Objective examination: pulse 61 beats/min. BP 128/76 mm Hg. Art., respiratory rate 17 per minute, no edema.

ECG: sinus rhythm, bradycardia (58 bpm).

TSHH 460 m.

EchoCG: EF - 64%; KDO - 107 ml; KSO - 38 ml; The cavities are not enlarged, there is no chamber hypertrophy, no remodeling. General contractility is normal, no violation of local contractility was detected. Type 1 diastolic dysfunction. Valves unchanged.

MSCT-KAG: right type, narrowing of the LCA trunk - 20%; muscle bridge in the middle segment of the PNA; proximal RCA segment - 15%.

According to dynamic myocardial SPECT, it was determined that the global reserve of coronary blood flow is 1.36 (Fig. 3).

NT-proBNP - 169.7 pg/ml (N < 125 pg/ml)

Diagnosis: coronary artery disease: angina pectoris FC II. Background: hypertension stage 3, achieved target blood pressure. Obesity 1 degree. Risk 4. CHF FC I (NYHA).

Thus, in patient G, who does not have symptoms and signs of CHF against the background of non-occlusive coronary atherosclerosis, according to myocardial dSPECT, the value of the global reserve of coronary blood flow was less than 2.27, which gives grounds to diagnose the presence of HFpEF at an early, preclinical stage. An NT-proBNP level above the reference value confirms the presence of HFpEF. In accordance with the current recommendations for the treatment of CHF, the patient was prescribed an ACE inhibitor to optimize therapy.

The proposed method has been tested on 47 patients and allows diagnosing chronic heart failure with preserved left ventricular ejection fraction in patients with non-occlusive coronary atherosclerosis in the early, presymptomatic stages of CHF by analyzing the magnitude of the global reserve of coronary blood flow. This makes it possible to single out a priority group of patients with one of the most common diseases among the working-age population of the world for dispensary observation and the appointment of personalized treatment.

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Claims (1)

A method for diagnosing heart failure with preserved left ventricular ejection fraction in patients with coronary heart disease against the background of non-occlusive atherosclerosis of the coronary arteries, characterized in that the global reserve of coronary blood flow is determined using dynamic single-photon emission computed tomography of the myocardium, and with a value of 2.27 and less diagnose chronic heart failure with preserved left ventricular ejection fraction.

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