RU2428923C1 - Method of estimating vasomotor function of endothelium with application of reovasography - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: registered is reovasogram of upper extremity in initial state and in period of reactive hyperemia, created during occlusion test, realised by pumping air in cuff for 5 minutes to pressure, exceeding SAP by 50 mm Hg, with following sharp decompression. Electrodes from reograph are applied on area of hand, occlusive cuff being applied on forearm. By relative change of amplitude of main wave of reovasogram (öA%), calculated by formula öA%=(A(Om)av.value. 2-3 min - A(Om) init.)/A(Om) init. ù 100%, where A(Om)init. is initial value of amplitude of main wave of reovasogram, A(Om) av.value 2-3 min is average value of amplitude of main wave of reovasogram at 2-nd and 3-rd minute of postocclusion hyperemia, vasomotor function of endothelium is estimated: as normal, if öA% is higher than 23.2%, disturbed, if öA% equals or is lower than 23.2%. ^ EFFECT: method extends arsenal of means for estimation of vasomotor function of endothelium. ^ 2 tbl, 5 dwg

Description

The invention relates to medicine, namely cardiology, and can be used to assess the vasomotor function of the endothelium.

Endothelial dysfunction (DE) is currently considered as one of the main pathogenetic mechanisms for the development and progression of cardiovascular disease (CVD) [14, 18, 24, 31, 32, 47, 60]. DE is manifested by a violation of neurohumoral regulation of vascular tone, their remodeling, activation of thrombogenesis and inflammation in the vascular wall [20, 46, 48, 59]. Endothelium is a therapeutic target in the treatment of CVD [5, 8, 25, 28, 33, 34, 49].

In the clinic, endothelial function is studied by laboratory and instrumental methods [1-3, 9, 14, 18, 20, 21, 33]. Instrumental methods for studying the endothelial function of peripheral and coronary arteries include invasive technologies, such as quantitative coronary angiography (CAG), CAG in combination with intracoronary ultrasound, and non-invasive methods, veno-occlusion plethysmography, magnetic resonance imaging, ultrasound [1-3, 9, 21, 22, 23, 41, 61]. The study of endothelial function is based on the endothelium-dependent response to various pharmacological and physiological stimuli [1-3, 9, 15-17, 28, 33, 34, 41, 61].

In recent years, the most widely used instrumental method for assessing vasomotor function of endothelium (VFE) is the study of flow-dependent dilatation of the brachial artery (PZVD) in a sample with post-occlusal reactive hyperemia (PRG) using high-resolution ultrasound (US) according to Celermajer DS (1992) [ 39, 40]. The method is based on endothelial mechanosensitivity, which normally causes expansion of the artery with an increase in the blood flow velocity in it [4, 15-17, 27, 29, 30, 52, 54, 55]. According to the research protocol, the brachial artery with blood flow in it in the initial state and in the period of reactive hyperemia created by sharp decompression of the occlusive cuff placed on the shoulder or forearm for 5 minutes with a pressure exceeding systolic blood pressure by 50 mm Hg is visualized using an ultrasonic vascular sensor. . Assessment of the vasomotor function of the endothelium is carried out according to the index of PZVD, calculated by the formula PZVD = [(D react.hyp. - D ref.) / D ref] × 100%, where PZVD - flow-dependent vasodilation, D react.hyp. - diameter of the brachial artery after 60-90 s after decompression of the cuff, D ref. - the initial diameter of the brachial artery.

The diameter of the brachial artery is estimated from the video recording of the study using the direct measurement method using ultrasonic cursors. One ultrasonic cursor is mounted on the adventitia-media interface of the anterior artery wall, and the other on the media adventitia interface of the far artery. In general, endothelium-dependent dilatation of the brachial artery in healthy people is from 6% to 10% [1-3, 21, 23, 38, 39]. With DE in CVD patients, a decrease in vasodilation or pathological vasoconstriction occurs. The method is non-invasive and has proven itself in various studies [1-3, 34-38, 42, 50, 53, 56]. However, there are certain limitations: the need for expensive expert-grade ultrasound equipment, highly qualified specialists, high labor intensity, which makes it possible to use the method only in research centers for research purposes [42, 50, 62].

The need for new methods for assessing VFE that are available for widespread use determines an active search for their development. New methods proposed by both domestic and foreign authors are mainly based on the contour analysis of the pulse wave or the study of the pulse wave velocity (SST) during various endothelial stimulating samples [6, 11, 12, 19, 26, 44, 45, 51, 57, 58]. However, the accuracy of the new methods, their sensitivity and specificity have not been studied. Leading experts emphasize that there is no optimal methodology for studying various aspects of DE, including diagnostic criteria, the conditions for standardizing research have not been developed [43].

A prototype of the present invention is the described method for evaluating VFE during shoulder reovasography in a sample with reactive post-occlusive hypermia [25, 7]. The electrodes from the rheograph and the occlusal cuff are placed on the shoulder. Reovasography of the shoulder is performed in the initial state and in the period of post-occlusal reactive hyperemia (PRG), created by forcing air into the occlusal cuff to a pressure exceeding the SBP by 50 mm Hg. As a criterion for evaluating VFE, an indicator of the relative change in the maximum volumetric blood supply velocity (Δdz / dt) calculated using the formula: Δdz / dt = ((dz / dt 1 '- dz / dt out.) / Dz / dt out.) × 100 %, where dz / dt ref. and dz / dt 1 'is the maximum volumetric rate of blood supply at rest and one minute after decompression, respectively. With a value of Δdz / dt≥12%, it is believed that VFE is not disturbed, from -2% to 12% - a moderately pronounced violation of VFE; from -2% to -15% - a pronounced violation of VFE and Δdz / dt <-15% - a pronounced violation of VFE [25, 7]. However, the authors do not explain in connection with what exactly these criteria for evaluating VFE were chosen. The authors did not compare the results of the VFE assessment by the new method with the results of the traditional methods of VFE assessment, the sensitivity and specificity of the new method were not determined, the reproducibility of the research results was not studied.

The objective of the present invention is to create a new method for assessing VFE, available for widespread use, with developed clear diagnostic criteria for endothelial dysfunction, with certain sensitivity and specificity of the method, with studied reproducibility of the research results. This problem is solved by the development of a method in which, unlike the prototype:

1) the field of study is the brush and the electrodes from the rheograph are applied to the wrist and base of the fingers;

2) an occlusive cuff is placed on the forearm;

3) the VFE is estimated by the relative increase in the amplitude of the main wave of the rheovasogram of the brush during the test with post-occlusal reactive hyperemia (ΔA%), calculated by the formula ΔA% = (A (Ohm) cf. value 2-3 min - A (Ohm) ref.) / A (Ohm) ref. × 100%, where A (Ohm) ref. - the initial value of the amplitude of the main wave of the RVG, A (Ohm) cf. 2-3 min - the average value of the amplitude of the main wave of the rheovasogram (RVG) at the 2nd and 3rd minute of post-occlusal hyperemia. In this case, the optimal value of the “separation point” of people with normal and impaired VFE is ΔA% ≤23.2. With a value of the criterion ΔA%> 23.2, normal VFE is diagnosed, with a value of ΔA% ≤23.2 a violation of VFE is diagnosed.

Evaluation of VFE according to the invention is as follows:

Preparation for the study: in the morning on an empty stomach, eliminate smoking, physical and psycho-emotional stress 6 hours before the study, stop taking vasoactive drugs 24 hours before the study if possible.

Conducting research:

1. After resting for 10 minutes in comfortable conditions, the test subject is laid on a couch on his back.

2. On the right hand on the area of the hand (wrist and base of the fingers) impose electrodes (Fig.1, pos.1-2) from the rheograph. A cuff is placed on the left arm from the apparatus for measuring blood pressure.

3. At the level of the middle third of the forearm, an occlusive cuff is applied on the right (Fig. 1, item 3).

4. The initial rheovasogram (RVG) of the brush is recorded for five minutes (continuous recording on computerized rheographs or 10 complexes on analog instruments every minute) and the initial blood pressure level is measured (two measurements).

5. In the occlusal cuff, for five minutes, a pressure of 50 mmHg is increased, exceeding the GARDEN. Within 5 minutes of occlusion, the subject's blood pressure level is monitored (two measurements).

6. After a sharp decompression for five minutes continue the registration of the RVG (continuous recording on computerized rheographs or every minute registration of 10 complexes on analog devices) and control the level of blood pressure (three measurements) (figure 2).

7. The VFE is estimated by the ΔA% indicator (the relative increase in the amplitude of the main wave of the RVG brush during the test with the PRG), calculated by the formula ΔA% = (A (Ohm) cf. value 2-3 min - A (Ohm) out. ) / A (Ohm) ref. × 100%, where A (Ohm) ref. - the initial value of the amplitude of the main wave of the RVG (average value for the selected one minute of the initial state), A (Ohm) cf. 2-3 min - the average value of the amplitude of the main wave of RVG at the 2nd and 3rd minute of post-occlusive hyperemia. With a value of ΔA%> 23.2, normal VFE is diagnosed, with a value of ΔA% ≤23.2 a violation of VFE is diagnosed.

The development of a new method for evaluating VFE was carried out in two stages based on a comparison with the results of evaluating VFE using the traditional ultrasonic method (the “gold standard”).

At the first stage, a wide group was formed of people with both potentially normal and impaired VFE (healthy men 20-40 years old and patients with hypertension I-III, art. 20-72 years old).

At the second stage, clinical testing of the new method was carried out in a group of men 20-40 years old with AH of the first degree.

A total of 140 people were examined, of which: 34 - patients with hypertension of I-III art. (female - 19, male - 15) 41-72 years old, average age 58.3 ± 1.3 years (GARDEN / DBP = 159.6 ± 2.9 / 96.8 ± 1.6 mm Hg .); 76 - patients with hypertension of the 1st art. men 20-40 years old, average age 30.4 ± 0.7 years (SBP / DBP = 149.6 ± 0.9 / 93.9 ± 0.9 mm Hg); 30 - practically healthy men 20-40 years old, average age 28.3 ± 0.9 years with normal blood pressure (SBP / DBP = 125.4 ± 1.1 / 76.2 ± 1.0 mm Hg) - control group (table 1).

All subjects examined in the morning on an empty stomach were assessed for VFE in two ways: by ultrasound according to Celermajer D.S. on an ultrasonic device of the expert class Vivid 7, GE (Medical Systems, USA) using a linear M 12L sensor and a new one - reovasography of a brush in a sample with post-occlusal reactive hyperemia using a computerized rheography-polyanalyzer RGPA-6/12 with the software "REAN-POLY ”(NPKF“ Medicom MTD ”, Taganrog). Subsequently, recorded reovasograms were analyzed separately in groups with impaired (PVDV <6%) and normal VFE (PVVD≥6%) according to the traditional ultrasound method (the “gold standard”).

Statistical processing of the results was carried out using the statistical programs Medcalc and Statistica 6.0. Group mean values are presented as M ± SE. Intergroup differences were calculated using the non-parametric Mann-Whitney test. The differences at p <0.05 were considered significant, statistically significant. When studying the relationships, the Pearson correlation coefficient and Spearman's rank correlation coefficient were calculated. When analyzing the sensitivity and specificity of the developed new methods, the method of calculating operational characteristics, “ROC analysis,” was used. In assessing the reproducibility of the results of new methods (the degree of agreement between the conclusions of repeated studies), we used the calculation of the K index (Carra).

It was revealed that the optimal quantitative indicator of the rheovasogram separating people with normal and impaired VFE during the test with PWG is the amplitude of the main wave of the rheovasogram (A (Ohm)) in both absolute and relative values (Fig. 3) in individuals with normal VFE in the period of post-occlusal RG there is an increase in A (Ohm) both in absolute and in relative to the initial values, while in case of violation of VFE there is a tendency to decrease in the absolute value of A (Ohm), and in relative numbers of changes practically Observed. Subsequently, “calculated indices” were formed from this indicator, and each of them was used to study the correlation with the index PZVD% (the “gold standard”), and the possibility of estimating VFE was studied by the “ROC analysis” method. At the same time, the ΔА% criterion (relative increase in the amplitude of the main wave of the rheovasogram of the brush during the test with reactive hyperemia), calculated by the formula ΔА% = (A (Ohm) cf. value 2-3 min, turned out to be the optimal "calculated index" for evaluating VFE A (Ohm) out.) / A (Ohm) out. × 100%, where A (Ohm) ref. - the initial value of the amplitude of the main wave of the RVG (average value for the selected one minute of the initial state), A (Ohm) cf. 2-3 min - the average value of the amplitude of the main wave of RVG at the 2nd and 3rd minute of post-occlusive hyperemia. The relationship of the indicator ΔA% with the index of the PZVD ("gold standard") is positive and reliable (r = 0.4, p <0.0001) (figure 4). During the ROC analysis, a “cut-off point” was determined that separates people with normal and impaired VFE, equal to ΔА% ≤23.2. With a value of ΔA%> 23.2 diagnose normal VFE, with a value of ΔA% ≤23,2 diagnose a violation of VFE (figure 5).

The analysis of the reproducibility of the results of VFE assessment by a new method of brush reovasography in a sample with PRG was performed in 12 people who were re-tested on the same day with an interval of 15-20 minutes. It was revealed that the “coefficient K” (Carr) (reproducibility by the final result - consistency of the conclusion on the presence or absence of a VFE violation) when using the endothelial dysfunction criterion ΔА% ≤23.2 is 0.8 (“very good” reproducibility).

At the second stage, during the clinical testing of the developed new method for evaluating VFE in the group of young men with AH of the first degree (n = 54), violation of VFE when using ΔA% ≤23.2% as the “separation point” was diagnosed in 24 (48%) of the analyzed 50 rheovasograms of patients with AH of the first degree of men of young age, while according to the ultrasound method for assessing VFE, violation of VFE (PZVD <6%) was detected in 46% of the examined. Thus, when assessing VFE in two ways (traditional ultrasound and new rheovasographic) in young men aged 20–40 years (76 patients with AH of the first degree and 30 in healthy subjects), according to the ultrasound method, violation of VFE in 39/76 (51 %) of patients with AH and 4/30 (13%) practically healthy (but smokers!) examined, according to the new rheovasographic method - violation of VFE in 38/71 (53%) of patients with AH and 10/30 (33%) of the group control (table 2).

An ultrasound of VFE in the control group in 29 out of 30 (97%) practically healthy young men with normal blood pressure levels in the WG period showed an expansion of the diameter of the brachial artery and with fluctuations from 0% to 19.3%, the mean value of the PVDD was 10, 0 ± 0.8%, which is significantly higher than similar indicators in the group of patients with AH of the first degree of young men, where the values of PZVD ranged from -2.3% to 18.4% and averaged 6.3 ± 0.7% ( p = 0.0017). In 5 patients with AH (6.6%), a pathological vasoconstriction was observed in the period of the RG. In a reovasographic study of VFE in a group of practically healthy young men, 93% (28/30) in the period of reactive hyperemia showed an increase in the amplitude of the main wave of rheovasogram and mean group indicators ΔA% = 34.8 ± 3.1 were higher than similar indicators in the group of hypertensive patients, where the average value of ΔA% was 25.0 ± 3.3.

When studying the degree of consistency of conclusions on the final result (normal or impaired VFE) according to the ultrasound method and the method for registering pulse blood filling of the hand during reovasography of the hand in a sample with post-occlusive reactive hyperemia, the “coefficient K” (Carr) turned out to be 0.6 (“good” degree matches).

We developed a method for detecting VFE disturbance during rheovasography of a hand in a sample with PRG showed sufficient accuracy for the screening method when examining patients with the most common pathology of the cardiovascular system - AH. The capabilities of the new method have been demonstrated in young people with AH of the first degree, which makes it possible in the long term to early detect violations of VFE with its subsequent correction.

The developed new method for evaluating the VFE of the rheovasography of the hand in a sample with PRG was clinically tested to detect violations of the VFE as in the conditions of the Institute of Cardiology named after A.L. Myasnikov on a computerized rheograph-polyanalyzer RGPA-6/12 with software "REAN-POLI" (NPKF "Medicom MTD" Taganrog), and in city polyclinics No. 88 and No. 22 of the South-Western district of Moscow on reograph 4 RG-2M (NPO Ekran) and the computerized reograph Kredo - ATES (ATES Medica). The principal possibility of applying the method to rheographs of different models (both digital and analog) is demonstrated. Potentially, this opens up new possibilities for examining patients with a cardiological profile and revealing violations of VFE in medical institutions, including at the primary health care level.

Contraindications for using the method for evaluating VFE during rheovasography of a hand in a sample with post-occlusive reactive hyperemia are:

1. Vascular diseases of the investigated upper limb (thrombophlebitis, arteritis, severe stenosing atherosclerosis).

2. Syndrome of the vertebral subclavian robbery.

3. Arterial hypertension of the III degree (SBP≥180 mm Hg, DBP≥110 mm Hg).

4. Atrial fibrillation.

5. Any acute inflammatory and other pathological conditions.

The advantages of the proposed new method in comparison with the prototype are:

1. The best tolerance of the study in connection with the selected area of study (hand) and more distal application of the occlusal cuff (on the forearm), which excludes the possibility of hypertensive reactions from the subject (as when applying the occlusal cuff on the shoulder in the prototype) and, accordingly, excludes erroneous interpretation of the results.

2. Evaluation of VFE by indicators of pulse blood supply to the hand in the proposed method in comparison with indicators of blood supply to the shoulder (in the prototype) is a more optimal solution, since according to the data of LB Ivanov and V. A. Makarov (2000), the RVG amplitude is significant the influence is exerted by the volume of soft tissues surrounding the arteries, which perform a non-pulsating or low-pulsating role of a shunt for a probe electric current [10, 13]. Therefore, the smaller the volume of surrounding soft tissues with a constant clearance of the main vessel and with the same volume of pulse blood supply, the greater the amplitude of the RVG. In this connection, the normative indicators of the amplitude of the RVG of the shoulder are lower than those for the hand. At low RVH amplitudes, certain difficulties arise in the analysis. And the most important thing is that the examined persons have different anthropometric indicators, a lot of people with excess body weight, and, accordingly, a large amount of soft tissue on the shoulder, in connection with which it is not possible to develop a universal criterion for the violation of VFE with shoulder RVG. On the RVG of the hand, where the contribution to the formation of the amplitude of the RVG of the surrounding soft tissue arteries is minimal, a more unambiguous interpretation of the amplitude parameters of the RVG and, accordingly, their changes during the test with PRG is possible.

3. Developed for the assessment of VFE, the ΔA% indicator reliably positively correlates with the index of PZVD% obtained in the traditional ultrasonic study of VFE: r = 0.4, p <0.0001 (Fig. 4). For this indicator, accurate diagnostic criteria for endothelial dysfunction have been developed.

4. The sensitivity and specificity of the new method in detecting endothelial dysfunction, which were 78% and 75%, respectively, were determined (Fig. 5).

5. Defined and shown good reproducibility of the results of the new method. The degree of agreement between the conclusions in repeated studies (“coefficient K” (Carr)) was 0.8, which is interpreted as “very good reproducibility”.

6. The degree of consistency of conclusions on the final result (normal or disturbed VFE) was determined according to the ultrasound method (the "gold standard") and a new method for registering pulse blood filling of the hand during reovasography in a sample with PRG: "coefficient K" (Carr) turned out to be 0, 6 (“good” degree of coincidence).

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Claims (1)

A method for evaluating the vasomotor function of the endothelium, including registration of a rheovasogram of the upper limb in the initial state and in the period of reactive hyperemia created with an occlusion test performed by injecting air in the cuff for 5 minutes to a pressure exceeding the SBP by 50 mm Hg, followed by sharp decompression and calculating the relative change in the quantitative indicators of the rheovasogram, characterized in that the electrodes from the rheograph are applied to the area of the hand (wrist and base of the fingers), and the occlusal cuff to the forearm and the relative change in the amplitude of the main wave of the rheovasogram (ΔA%), calculated by the formula ΔA% = (A (Ohm) cp.value 2-3 min - A (Ohm) out.) / A (Ohm) out. × 100%, where A (Ohm) ref. - the initial value of the amplitude of the main wave of the reovasogram, A (Ohm) cf. 2-3 min - the average value of the amplitude of the main wave of the rheovasogram at the 2nd and 3rd minute of postocclusal hyperemia estimates the vasomotor function of the endothelium as normal at ΔA%> 23.2% and as impaired at ΔA% ≤23.2%.

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