RU2428924C1 - Method of estimating vasomotor function of endothelium with application of volume sphygmograph - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: by means of volume sphygmography with application of cuffs for sphygmogram registration on shoulder and forearm, measurement of pulse wave rate (PVR) is carried out on section "shoulder-forearm" in initial state and in period of post-occlusion reactive hyperemia (PRH), created by sharp decompression of occlusion cuff. Occlusion cuff is applied on wrist, occlusion is created for 5 minutes by pumping air in cuff to the pressure level exceeding SAP by 50 mm Hg. Estimation of VFE is performed by parameter of relative PVR reduction at 2-nd-3-rd minutes of PRH state (öPVR%). Calculation is performed by formula öPVR%=(PVRinit.-PVR minim. 2-3 min.)/PVR initx100%, where PVR init. is initial PVR (median of three values), PVR minim. 2-3 min is minimal PVR value at 2-nd - 3-rd minutes of PRH. If öPVR% value equals or is higher than 5.1 normal VFE is diagnosed, if öPVR% value is lower than 5.1, VFE disorder is diagnosed. ^ 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) [12, 17, 23, 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 [19, 46, 48, 59]. Endothelium is a therapeutic target in the treatment of CVD [5, 8, 24, 27, 33, 34, 49].

In the clinic, endothelial function is studied by laboratory and instrumental methods [1-3, 9, 12, 17, 19, 20, 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, 20-22, 32, 40, 41, 61, 62]. The study of endothelial function is based on the endothelium-dependent response to various pharmacological and physiological stimuli [1-3, 9, 13-15, 28, 32, 33, 40, 41, 61, 62].

In recent years, the most widely used instrumental method for assessing vasomotor function of the endothelium (VFE) is the study of flow-dependent dilatation of the brachial artery (PZVD) in a sample with post-occlusive reactive hyperemia (PRG) using high-resolution ultrasound (US) according to Celermajer D.S. (1992) [38, 39]. The method is based on endothelial mechanosensitivity, which normally causes expansion of the artery with an increase in the rate of blood flow in it [4, 13-15, 26, 28-30, 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 60-90 seconds 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, 20, 22, 37-39, 41]. 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, 33-39, 41, 50, 53, 56]. However, there are certain limitations: the need for expensive ultrasound equipment of the expert class, highly qualified specialists, high complexity, which makes it possible to use the method only in research centers for research purposes [41, 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, 7, 10, 11, 18, 25, 43, 44, 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 [42].

A prototype of the present invention is the described method for evaluating VFE using the registration of the pulse wave velocity in a sample with post-occlusive reactive hyperemia in patients with chronic heart failure (CHF) and healthy people using the QVL-TM device, SciMed [51]. The study of SPV was carried out simultaneously on the upper and lower extremities using four cuffs placed on the shoulder, wrist, lower leg and ankle. Occlusion was created by injecting air for 5 min to 250 mm Hg. in distal cuffs (on the wrist and ankle). Analysis of the results of the study was carried out in terms of the degree of reduction of SST in the first minute of PWG, and also within 10 minutes of PWG. The study showed that in the upper extremities of healthy people in the first minute of PWG there is a decrease in SST by 14.2%, in the lower extremities by 13.9%; in patients with heart failure, the decrease in the arm was 5.1%, in the leg - 8.8%. Within 10 minutes of PWG in healthy patients, the decrease in PWS on the arm and leg was 10.1% and 8.3%, respectively, in patients with heart failure 3% and 2.8%, respectively. Thus, in patients with heart failure a significant decrease in VFE was demonstrated in comparison with the control group. The work indicates that similar significant differences in patients with heart failure and in healthy individuals are also observed according to the results of ultrasound examination of the VFE of the brachial artery, however, the authors do not present the results of a comparison of these data, they do not analyze the sensitivity and specificity indicators for a new method of assessing VVE, diagnostic criteria are not developed endothelial dysfunction.

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 only area of study was chosen - the “shoulder-forearm” section and the cuffs from the sphygmograph for registration of SST are placed on the shoulder and forearm (only two cuffs);

2) occlusion is created by forcing air in the occlusal cuff to a pressure exceeding the GARDEN by 50 mm Hg;

3) VFE is assessed according to the relative reduction of DSS at the 2-3rd minute of the state of PWG (ΔSPV%), calculated by the formula ΔSPV% = (SPV out. - SPV min. 2-3 min) / SPV out. × 100% where SPV ref. - initial DSS (median of their three values), DSS minim. 2-3 minutes - the minimum value of the SST at the 2-3rd minute of the PWG. With a value of ΔSPV% ≥5.1, normal VFE is diagnosed, with a value of ΔSPV% <5.1, 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 arm, cuffs from the sphygmograph Vasera, VS-1000 (Fukuda Denshi, Japan) are applied to the region of the shoulder and forearm to record SPV. The distance between the upper edges of the cuffs is measured. At the level of the wrist on the right impose an occlusal cuff (figure 1)

3. On the left hand impose a cuff from the apparatus for measuring blood pressure.

4. Spend within 5 minutes, the registration of the initial values of the SST in the area of "shoulder-forearm" (three measurements) with simultaneous measurement of blood pressure.

5. In the occlusal cuff, a pressure is injected for five minutes, 50 mm Hg higher than 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, SPV is recorded (5 measurements) with simultaneous control of blood pressure (Fig.2).

7. EFC is estimated by the ΔSPV% indicator calculated by the formula ΔSPV% = (SST outgoing - SST minimum. 2-3 min) / SST initial. × 100%, where SST initial - initial SST (median of three values) , SPV min. 2-3 min - the minimum value of SST at the 2-3rd minute of the PWG. With a value of ΔSPV% ≥5.1, normal VFE is diagnosed, with a value of ΔSPV% <5.1, a violation of VFE is diagnosed.

8. Due to the fact that when developing a new method for assessing VFE using the Vasera sphygmograph, VS-1000 (Fukuda Denshi, Japan), the standard cuff overlay was changed (the ankle cuff is superimposed on the forearm), the true SST value (at each measurement point) for use in the above formula is calculated by the formula: SST source = L1 × SST ap. / L2, where SST source. - the true value of the SST on the shoulder-forearm section in m / s, L1 is the distance between the cuffs on the shoulder and the forearm in m, SST ap. - the value of the SST issued by the device in m / s, L2 is the distance "shoulder-ankle", automatically calculated by the device in m / s.

The development of a new method for evaluating VFE was carried out in two stages based on comparison with the results of evaluating VFE in the traditional ultrasonic way (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 ultrasound device of the expert class Vivid 7, GE (Medical Systems, USA) using a linear M 12L sensor and a new one - volumetric sphygmography in a sample with post-occlusal reactive hyperemia using a Vasera, VS-1000 sphygmograph (Fukuda Denshi, Japan). Subsequently, the recorded sphygmograms were analyzed separately in groups with impaired (PZVD <6%) and normal VFE (PZVD≥6%) according to the traditional ultrasonic 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 during the first minute of the post-occlusal RG period, almost all the examined had a decrease in the SST in the shoulder-forearm section on the right, but subsequently in people with normal VFE this decrease continued, and in people with impaired VFE, the SST began to increase and exceeded the initial values (figure 3). To characterize the degree of reduction of the DSS relative to the initial values, the ΔSPV% indicator was developed, calculated by the formula: ΔSPV% = (SPV out. - SPV min. 2-3 min) / SPV out. × 100%, where ΔSPV% is the degree of relative reduction in the SST, SST ref. - the initial value of the SPV, SPV min. 2-3 min - the minimum value of SST at the 2-3rd minute of the PWG. A positive reliable correlation between the ΔSPV% indicator and the PZVD% indicator (the "gold standard") was revealed: r = 0.6; p <0.0001 (Fig. 4). Using the "ROC analysis" method, the possibility of evaluating the VFE using the ΔSPV% indicator was studied. At the same time, the value ΔSPV% <5.1 turned out to be the optimal "cut-off point" separating individuals with normal and impaired VFE. With a value of ΔSPV% ≥5.1, normal VFE is diagnosed, with a value of ΔSPV% <5.1, a violation of VFE is diagnosed. The sensitivity and specificity of the method in detecting endothelial dysfunction are 78% and 88%, respectively (figure 5).

The reproducibility analysis of the results of VFE assessment by a new method of volumetric sphygmography in a sample with post-occlusive reactive hyperemia was performed in 11 people who were re-tested on the same day with an interval of 15-20 minutes. It was found that the "coefficient K" (Carr) (consistency of the conclusion on the presence or absence of a VFE violation - reproducibility according to the final result) when using as a criterion for endothelial dysfunction, ΔSPV% <5.1 is equal to 1.0 (complete coincidence of conclusions in repeated studies )

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 = 70), the violation of VFE when using the ΔSPV% <5.1 as the “separation point” was diagnosed in 44% of the examined, while while according to the data of the ultrasonic method for assessing VFE, violation of VFE (PZVD <6%) was detected in 49%. Thus, when assessing VFE in two ways (traditional ultrasound and a new method of volumetric sphygmography in a sample with PRG), in young men aged 20-40 years (76 - patients with AH of the first degree and 30 - healthy), it was revealed according to the ultrasound method - violation of VFE in 39/76 (51%) patients with AH and 4/30 (13%) practically healthy (but smokers!) examined, and according to the new method of volumetric sphygmography in a sample with PRG, a violation of VFE in 31/72 (43%) patients AH and 6/30 (20%) of individuals from the control group (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. When VFE was estimated by the method of volume sphygmography in a sample with PRH in a group of healthy young men, 93% (28/30) showed a decrease in SST in the period of reactive hyperemia and ΔSPV% averaged 8.01 ± 0.8, which was significantly higher than the group average in young men with hypertension: 5.64 ± 0.6 (p <0.05). In patients with hypertension, ΔSPV% values ranged from 16.3 to -7.6. In 9.7% (7/72) patients there was an increase in SST at 2-3 minutes of reactive hyperemia.

When studying the degree of consistency of conclusions on the final result (normal or disturbed VFE) according to the ultrasound method and the method of volumetric sphygmography in a sample with post-occlusive reactive hyperemia, the "coefficient K" (Carr) was equal to 0.8 ("very good" degree of coincidence).

We developed a method for detecting VFE disturbance during volumetric sphygmography 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 in the future gives the possibility of early detection of violations of VFE with its subsequent correction. Potentially, this opens up new possibilities for detecting EHF disorders in patients with a cardiological profile in medical institutions, including at the primary health care level.

Contraindications for using the method for assessing VFE using volumetric sphygmography 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 spinal subclavian theft

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 only area of study “shoulder-forearm” and a more gentle regimen of occlusion (air injection in the occlusal cuff to a pressure exceeding the GARDEN by 50 mm Hg, unlike the prototype, where the pressure is two occlusal cuffs are injected up to 250 mmHg and two areas are studied simultaneously (upper and lower limbs), which excludes the possibility of hypertensive reactions from the subject and, accordingly, excludes erroneous interpretation of the results.

2. The ΔSPV% indicator developed for estimating VFE is significantly positively correlated with the PVDV% indicator obtained by traditional ultrasonic investigation of VFE ("gold standard"): r = 0.6, p <0.0001 (Fig. 4). For this indicator, the exact diagnostic criteria for the violation of VFE are calculated.

3. The sensitivity and specificity of the new method in detecting endothelial dysfunction, which were 78% and 88%, respectively, were determined (Fig. 5).

4. Defined and shown good reproducibility of the results of the new method. The degree of agreement between the findings in repeated studies (“coefficient K” (Carr)) was 1.0; which is interpreted as "the complete coincidence of conclusions in repeated studies."

5. The degree of consistency of conclusions on the final result (normal or violated VFE) was determined according to the data of the ultrasonic method (the “gold standard”) and the new method: “coefficient K” (Carr) turned out to be 0.8 (“very good” degree of coincidence).

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Claims (1)

A method for evaluating the vasomotor function of the endothelium, including volumetric sphygmography with registration of the pulse wave velocity in the initial state and in the period of reactive hyperemia, created with an occlusal test performed by injecting air in the occlusal cuff for 5 minutes, followed by a sharp decompression and calculating the relative change in the pulse wave velocity, characterized in that the cuffs from the sphygmograph are placed on the shoulder and forearm, and the occlusion cuff on the wrist, the occlusion is created air in the cuff to a pressure exceeding the GARDEN by 50 mm Hg and the relative decrease in the pulse wave velocity ΔSPV%, calculated by the formula ΔSPV% = (SPV out. - SPV min. 2-3 min) / SPV.Ch. 100%, where ΔSPV% - the degree of relative reduction in the SST, SST ref. - the initial value of the SPV, SPV minimum 2-3 min - the minimum value of SST at the 2nd-3rd minutes of post-occlusal reactive hyperemia is assessed by the vasomotor function of the endothelium as normal at ΔSPV% ≥5.1 and as impaired at ΔSPV% <5.1.

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