RU2522397C1 - Diagnostic technique for arteriovenous fistula stenosis in long-term hemodialysis patients with end-stage chronic renal disease - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: arteriovenous fistula stenosis in long-term hemodialysis patients with end-stage chronic renal disease is diagnosed by four or more criteria: mean corpuscular volume (MCV) more than 93.3 ml, mean corpuscular hemoglobin (MCH) of more than 32.2 pg/l, urea concentration (Urea) more than 15.9 mmole/l, post-dialysis urea (Ur_KT/V) more than 4.2 mmole/l, mid-dialysis urea (Ur_PCR) more than 4.5 mmole/l, as well as dialysis efficacy (Kt/V) less than 1.71 units and equilibrated Kt/V (Kt/Veqv) less than 1.54 units.

EFFECT: technique enables diagnosing the presence or absence of any stenosis changes in an arteriovenous fistula without additional laboratory and clinical studies that enable projecting a minimum surgical repair as may be necessary.

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Description

The present invention relates to medicine and can be used in nephrology for renal replacement therapy in patients with end-stage chronic kidney disease.

Over the past decade and a half, a pandemic of chronic kidney disease (CKD) has been reported among adults in the world. In Russia, the number of patients with CKD stage III ÷ V from 1995 to 2008 increased from 1313 to 8830 people. The life of such patients requires renal replacement therapy (RRT), which is most often carried out in the form of hemodialysis. In 2009, 17 324 people (122 per million of the population) received PST in the program hemodialysis modality (PGD) [Bikbov BT, Tomilina N.A. The state of substitution therapy in patients with chronic renal failure in the Russian Federation in 1998-2009. (Report on the data of the Russian Register of renal replacement therapy) / Nephrology and dialysis - 2011. - T.13 - No. 3 - S.152-250].

The adequacy of PST using the PGD method is impossible without an adequately functioning constant vascular access that provides sufficient blood flow, has been functioning for many years, and has a minimal risk of complications dangerous to health and life. Given these requirements, “vascular access of first choice” remains the fundamental development of V.J. Brescia and J.E. Cimino (1966) operations for creating subcutaneous arteriovenous fistula (AVF) [European Best Practice Guidelines for Haemodialysis (Part 2) / Nephrol Dial Transplant. - 2007. - V.22 [Suppl 2] // http://www.oxfordjournals.org/our_journals/ndt/era_edta.html]. Complications associated with constant vascular access (PSD) are the main cause of the incidence, hospitalization and cost of treatment for patients on PGD [Rodriguez J.A., Armadans L., Ferrer E., et al. The function of permanent vascular access / Nephrol. Dial Transplant - V.2000 - P.402-408].

The main complication of PSD, requiring emergency surgery, is thrombosis, which is often a consequence of stenotic changes in AVF. For the diagnosis of hemodynamically significant stenosis (reduction in the normal diameter of the vessel> 50%), it is recommended: an examination to identify signs of infection, swelling of the extremities, the presence of bruises, aneurysms, vein collapse in the post-stenotic region when raising the hand above heart level. Palpation reveals a characteristic vibration. Auscultation reveals high-pitched noises [European Best Practice Guidelines for Haemodialysis (Part 2) / Nephrol Dial Transplant. - 2007. - V.22 [Suppl 2] // http://www.oxfordjournals.org/ourjournals/ndt/era_edta.html].

In many patients, due to the lack of prospects for the use of kidney transplantation, PSD is an absolute necessity throughout their entire subsequent life. Maintaining affordable, well-functioning AVFs is one of the most difficult clinical problems in the long-term treatment of patients with chronic hemodialysis. A significant role in solving this problem belongs to the prediction of possible complications at the preclinical level, the identification of hemodynamically insignificant stenosis. In this case, the success of both non-surgical intervention procedures and surgical correction methods will ensure the long-term functioning of the AFF.

An analogue of this method is traditional angiography using iodine-containing contrast agents, which is indicative of 96% of all cases. The disadvantage of this method is the presence of complications after the procedure in 17% of patients [Gani JS, Fowler PR, Steinberg AW, Wlodarczyk JH, Nanra RS, Hibberd AD. Use of the fistula assessment monitor to detect stenoses in access fistulae. Adv Ren Replace Ther. 2002 Apr; 9 (2): 91-98) /http://www.ncbi.nlm.nih.gov/pubmed/1996573], including those associated with nephrotoxicity of iodine-containing contrast during angiography performed before transferring the patient to programmed hemodialysis.

The closest analogue of the method is magnetic resonance imaging, which is a non-invasive method, characterized by the absence of radiation exposure, has a lower risk of complications and high information content. The sensitivity, specificity, prognostic value of a positive and the prognostic value of a negative result are 97%, 99%, 96% and 99%, respectively [Tordoir J., B. Canaud, P. Haage, et al. EBPG on Vascular Access / Nephrol Dial Transplant (2007) 22 [Suppl 2]: ii 88 - ii 117. - ii 101 // www.resir.nc/.../ebpg-vascular-access.pdf]. However, this method has significant disadvantages, since it can only be used in large hospitals and the cost of the study is quite high. In addition, the use of magnetic resonance imaging places a significant financial burden on the healthcare institution, which makes it impossible to apply this study regularly.

The objective of the proposed method is to search for clinical, biochemical and hematological parameters used for mandatory monthly monitoring of such patients, the value of which allows you to diagnose the presence of clinically not expressed stenosis of AVF in patients undergoing chronic hemodialysis for the purpose of their early diagnosis with the subsequent possibility of minimally invasive interventions , reducing the cost of a medical institution with constant monitoring of the absence of stenotic changes phenomena in arteriovenous fistula.

To solve this problem, a wide range of indicators was studied, including hematocrit (Ht), hemoglobin concentration (Hb), the content of red blood cells (Er), white blood cells (Ley), lymphocytes (LYM), neutrophilic granulocytes (NEUT), medium cells (MXD), platelets (Plt), mean erythrocyte volume (MCV), mean erythrocyte hemoglobin content (MCH), mean erythrocyte hemoglobin concentration (MCHC), blood osmolarity (OSMO), urea concentrations (Urea), urea at the end of dialysis (Ur_KT / V ), urea in the middle of dialysis (Ur_PCR), creatinine (Cre), albumin (Alb), phosphorus (P ), calcium (Ca), sodium (Na), potassium (K), glucose (Glu), transferrin (Tf), the activity of transaminases ACT and ALT, calculated indicators of the rate of protein catabolism (SKB) and the percentage reduction of urea (% d_Ur), as well as a number of clinical indicators - dry weight of the patient (Dry Weight), ultrafiltration (UF) and dialysis efficiency indicators (Kt / V) and balanced Kt / V (Kt / V _eqv ).

The study of these parameters in patients 2-4 months after the formation of PSD and one month of confident use in PGD procedures, as in a group of patients without signs of clinical and subclinical stenosis, was carried out. A study was also conducted in a group of patients in whom inadequate dialysis was recorded (low K × t / V), there was an ultrasound of signs of stenosis and its clinical manifestations. In these patients, the diagnosis was verified by surgical revision of the PSD.

Comparison of the values of the studied parameters using a nonparametric analogue of the analysis of variance - the Kruskal-Wallis test - showed that among them significant differences were observed in the average volume of red blood cells (MCV), average hemoglobin in red blood cells (MSN), urea concentrations (Urea), creatinine (Cre ), urea at the end of dialysis (Ur_KT / V), urea in the middle of dialysis (Ur_PCR), as well as dialysis efficiency indicators (Kt / V) and the balanced Kt / V (Kt / V _eqv ).

To test the capabilities of the studied indicators to serve as a diagnostic criterion for the development of AVF stenosis, we used the analysis of characteristic curves (ROC-curves), which describe the dependence of the sensitivity of a diagnostic test on its nonspecificity (1-specificity) [Fletcher R., Fletcher S., Wagner E. Clinical epidemiology. The basics of evidence-based medicine. / per. from English - M .: MediaSfera, 1998 - 352 p.]. Analysis of ROC-curves makes it possible to judge the diagnostic effectiveness of the test and allows you to find the cut-off point, which is the boundary between the two conditions of the patient. Diagnostic sensitivity (PM), diagnostic specificity (DS), cut-off point are shown in the table.

The results of the study of characteristic curves to assess the diagnostic applicability of the selected indicators of clinical and laboratory data. No. Indicator Dc DS Clipping point one Mch 61.5 81.3 > 32.9 pg / l 2 Urea 80.8 59.4 > 15.9 mol / l 3 Mcv 76.9 75.0 > 93.3 fl four Ur_PCR 83.3 78.1 > 4.2 mmol / l 5 Ur_KT / V 76.9 87.5 > 4.5 mmol / l 6 KT / V _eqv 88.5 81.3 ≤1.53 7 KT / V 88.5 81.3 ≤1.71

Thus, seven signs were obtained, the values of which are likely to indicate the presence of AVF stenosis. However, none of the proposed tests gives a 100% guarantee of the correct solution. Thus, for a reliable diagnosis of arteriovenous fistula stenosis, it is necessary to proceed in accordance with the methodology of the consilium of algorithms proposed by A.A. Genkin [Genkin A.A. New information technology for the analysis of medical data (OMIS software package). - St. Petersburg, Polytechnic - 1999 - 191 p.]. According to this methodology, the final diagnostic decision is made in accordance with the decision of most of the proposed algorithms. In this case, we consider each of the proposed tests as a diagnostic algorithm, and the decision on the presence or absence of stenosis is made in the presence of four or more tests that give the corresponding result.

The essence of the invention lies in the fact that the diagnosis of arteriovenous fistula stenosis in patients with end-stage chronic kidney disease, including program hemodialysis, is made in the presence of four or more signs from the following list: the average red blood cell volume (MCV) is more than 93.3 fl, the average content erythrocyte hemoglobin (SIT) over 32.2 pg / L, urea concentrations (Urea) over 15.9 mmol / L, urea at the end of dialysis (Ur_KT / V) over 4.2 mmol / L, urea in the middle of dialysis (Ur_PCR ) more than 4.5 mmol / l, as well as indicators of the effectiveness of di Lisa (Kt / V) of less than 1.71 units. and an equilibrated Kt / V (Kt / V _eqv ) of less than 1.54 units.

The technical result of the application of the method is the diagnosis of arteriovenous fistula stenosis in patients with end-stage chronic kidney disease who are on program hemodialysis before the onset of clinical manifestations, which helps to prevent the quality of dialysis and the development of life-threatening thrombotic lesions that can provoke generalized disorders of the blood coagulation system.

The method is as follows. In patients with end-stage chronic kidney disease undergoing hemodialysis, once a month, in accordance with the protocol for the management of such patients, the average erythrocyte volume (MCV) values, mean erythrocyte hemoglobin content (MCH), and urea concentrations (Urea) are determined ), urea at the end of dialysis (Ur_KT / V), urea in the middle of dialysis (Ur_PCR), dialysis efficiency indicators (Kt / V) and equilibrated Kt / V (Kt / V _eqv ), and if there are at least four and their values: MCV > 93.3 fl, MSN> 32.2 pg / L, Urea> 15.9 mmol / L, Ur_KT / V> 4 , 2 mmol / L, Ur_PCR> 4.5 mmol / L, and also Kt / V <1.71 units. and Kt / V _eqv <1.54 units. determine stenosis of arteriovenous fistula in these patients.

Example 1. Patient O., outpatient medical record No. 206060173 (Patient code in EuCliD ^© , Fresenius Medical Care).

He has been on treatment with programmed hemodialysis from 07/07/2004 to the present. The main diagnosis: chronic glomerulonephritis. Complications of the main: terminal stage of kidney damage. Concomitant: chronic viral hepatitis B without a delta agent.

In a screening study on December 16, 2011, the average erythrocyte volume (MCV) was 97.3 fl (> 93.3 fl → +1 point), and the average erythrocyte hemoglobin content (MSN) was 32.0 pg / l (<32.2 pg / l → 0 points), urea (Urea) concentrations of 25.4 mmol / l (> 15.9 mmol / l → +1 point), urea at the end of dialysis (Ur_KT / V) 4.9 mmol / l (> 4 , 2 mmol / L → +1 point), urea in the middle of dialysis (Ur_PCR) 6.2 mmol / L (> 4.5 mmol / L → +1 point), as well as indicators of dialysis efficiency (Kt / V) 1, 92 (<1.71 units → 0 points) and the balanced Kt / V (Kt / Veqv) 1.51 (<1.53 units → +1 point). As a result, there are five positive signs out of seven, which suggests a subclinical stenotic process. The patient has constant vascular access, an arteriovenous fistula, formed on 04/20/2004 in the distal third of the left forearm between a.radialis and the lateral vein of the v.cefalica basin. The patient underwent a clinical physical examination, taking into account the constitutional type, the patient’s long-term presence on PST and, as a result, the presence of complications of PSD in the form of aneurysms. Cartography of articularized veins was carried out, possible sections of stenotic changes were identified and indicated, an ultrasound study was recommended to confirm the diagnosis of stenosis, determine the level of localization in order to choose the tactics of patient management. When conducting an extraordinary ultrasound examination on February 17, 2012 (ACUSON ASPEN apparatus, USA), the convoluted nature of the course of articularized veins, the presence of several sections of the narrowing of the lumen and local increase in the linear velocity of blood flow were revealed. Aneurysmal expansion with parietal masses, a collateral type of blood flow in the proximal part of the venous network in the post-aneurysmal region in the middle and upper third of the forearm were found.

The planning of operational benefits in the amount of balloon angioplasty. Thrombosis of this PSD occurred before the planned surgical intervention - 02/18/2012, the patient was urgently taken to the operating room. A transverse incision was made 7 cm from the arteriovenous anastomosis over the second site of stenosis. The presence of stenosis was confirmed intraoperatively, excision of this site was performed. Thrombectomy with a Fogarty catheter. Stenosis was awakened at the first point 3 cm from the anastamosis in the projection of the lateral vein valve of the v.cefalica basin and thrombectomy from aneurysm and post-aneurysmal arterelized veins. Three weeks later, on 03/10/2012, PSD retrombosis, the patient was taken to the operating room. A transverse incision was made 3 cm from the arteriovenous anastamosis over the first section of stenosis. The presence of stenosis was confirmed intraoperatively, excision of this site was performed. A linear vascular prosthesis was implanted on the forearm between the arterialized lateral vein of the v.cefalica basin and v.basilica in the lower third of the shoulder, allowing its use as PSD after 24 hours (Vascutec Rapidax). Renal replacement therapy continues on reconstructed PSD. In this case, AVF thrombosis occurred earlier than the planned reconstructive surgery, which does not allow us to speak about the timely diagnosis of the complication, but this example served as one of the first lessons of careful attention to the proposed diagnostic method.

Example 2. Patient N., outpatient health record No. 206060507 (Patient code in EuCliD ^© , Fresenius Medical Care).

He has been on treatment with programmed hemodialysis from 02/12/2009 to the present. The main diagnosis: polycystic kidney disease. Complication of the main: secondary chronic pyelonephritis, latent course, terminal stage of kidney damage. Concomitant diagnosis: coronary heart disease, angina pectoris 2 fc, atherosclerosis of the aorta, coronary arteries, post-infarction cardiosclerosis after extensive penetrating myocardial infarction (2001, 2002), stenting of the coronary arteries (2002), chronic viral hepatitis B, combined hemorrhoids, umbilical hernia repair (1965), appendectomy (1978).

In a screening study on February 13, 2012, the urea concentration (Urea) was 28.9 mmol / L (> 15.9 mmol / L → +1 point), and the urea at the end of dialysis (Ur_KT / V) was 8.6 mmol / L (> 4 , 2 mmol / L → +1 point), as well as indicators of dialysis efficiency (Kt / V) 1.42 (<1.71 units → +1 point) and the balanced Kt / V (Kt / Veqv) 1.28 units (<1.54 units → +1 point). As a result, there are four positive signs out of seven possible, which suggests the presence of a subclinical stenotic process. A retrospective analysis of the indicators revealed the existence of values to diagnose the presence of a subclinical stenotic process at the previous stage of the study. The patient has constant vascular access, an arteriovenous fistula, formed on April 6, 2010 in the distal third of the right forearm between a.radialis and the lateral vein of the v.cefalica basin. The patient underwent a clinical physical examination, taking into account the constitutional type, the patient’s prolonged presence on the RRT and, as a result, the presence of complications of PSD in the form of aneurysms, cartography of articularized veins was carried out, possible sections of stenotic changes were identified and indicated, an ultrasound study was recommended to confirm the diagnosis of stenosis, determine the degree and the level of localization in order to choose the tactics of patient management. Ultrasound examination on April 3, 2012 (Sono Scape SSI 6000) revealed: a section of narrowing of the lumen and a local increase in the linear velocity of blood flow, aneurysmal expansion without parietal masses, a mixed type of blood flow in the proximal part of the venous network in the post-aneurysmal region in the middle and upper third of the forearm.

Planned and carried out (03.05.2012) operational allowance. A transverse incision was made 6 cm from the arteriovenous anastamosis behind the stenosis site, the presence of stenosis in the projection of the lateral vein valve of the v.cefalica pool was confirmed, the surgical aid was performed: Fogarty catheter patency control of the proximal v.cefalica and v.basilica; proximal reanastamosis. Renal replacement therapy continues on reconstructed PSD. As a result of the application of the method, a gradual clinically inexplicable decrease in the quality of dialysis procedures was prevented, which led to an improvement in the patient's quality of life.

Example 3. Patient A., outpatient medical record No. 206060808 (Patient code in EuCliD ^© , Fresenius Medical Care).

He has been on treatment with programmed hemodialysis from 02/02/2012 to the present. The main diagnosis: insulin-dependent diabetes mellitus. Complication of the main: diabetic nephropathy, terminal stage of kidney damage, extracorporeal dialysis, diabetic microangiopathy, diabetic polyneuropathy. Associated: secondary hypertension, chronic viral hepatitis B, overweight.

In the study of March 13, 2012, the concentration of urea (Urea) was 19.3 mmol / L (> 15.9 mmol / L → +1 point), and the urea at the end of dialysis (Ur_KT / V) was 7.0 mmol / L (> 4.2 mmol / l → +1 point), dialysis efficiency indicators (Kt / V) 1.17 units (<1.71 units → +1 point) and the balanced Kt / V (Kt / Veqv) 1.06 units (<1, 54 units → +1 point). As a result, there are four positive signs out of seven possible, which suggests the presence of a subclinical stenotic process. The patient has constant vascular access - the arteriovenous fistula formed on 11/01/2011 in the distal third of the left forearm between a.radialis and the lateral vein of the v.cefalica basin. The patient underwent a clinical physical examination, taking into account the constitutional type, the patient was kept for a short time, a cartography of articularized veins was carried out, a possible section of stenotic changes was identified and indicated, an ultrasound examination was recommended to confirm the diagnosis of stenosis, to determine the level of localization in order to choose the tactics of patient management. Ultrasound (March 29, 2012, ALOCA 5500 ultrasound scanner) revealed: the direct nature of the course of articularized veins, the area of narrowing of the lumen in the arteriovenous anastomosis and the local increase in the linear velocity of the blood flow, there are no aneurysmal enlargements, the main changed type of blood flow in the venous network, there are no signs of thrombosis.

The planning of operational benefits in the amount of proximal resuscitation. Surgical allowance was performed on April 11, 2012 from a longitudinal section 6 cm long above the arteriovenous anastomosis. Confirmed the presence of stenosis 1 cm from the anastamosis, excision of the stenotic section of the articularized vein was performed, control of the proximal patency of v.cefalica and v.basilica, Fogarty catheter; reconstructive surgery in volume - reanastamosis using a section of a vascular prosthesis. Renal replacement therapy continues on reconstructed PSD. The use of this method made it possible, without good clinical reasons, to suspect a patient with a newly created arteriovenous fistula of its stenosis, which made it possible to plan reconstructive surgery in a timely manner, prevent the development of fistula thrombosis, avoid a gradual clinically unexplained decrease in the quality of dialysis procedures and, consequently, worsen the quality of treatment of this patient .

Example 4. Patient F., outpatient medical record No. 206060502 ((Patient code in EuCliD ^© , Fresenius Medical Care).

He has been on treatment with programmed hemodialysis from 01/17/2009 to the present. The main diagnosis: Hypertensive [hypertonic] disease with a primary lesion of the heart and kidneys. Complications of the main: terminal stage of kidney damage.

In a screening study on April 16, 2011, the average erythrocyte volume (MCV) was 94.0 fl (> 93.3 fl → +1 point), and the average erythrocyte hemoglobin content (MSN) was 34.0 pg / l (> 32.2 pg / l → +1 point), urea concentrations (Urea) 18.3 mmol / l (> 15.9 mmol / l → +1 point), urea at the end of dialysis (Ur_KT / V) 5.3 mmol / l (> 4.2 mmol / L → +1 point), urea in the middle of dialysis (Ur_PCR) 4.6 mmol / L (> 4.5 mmol / L → +1 point), as well as dialysis efficiency indicators (Kt / V) 1 , 46 (<1.71 units → +1 point) and the balanced Kt / V (Kt / V _eqv ) 1.36 (<1.54 units → +1 point). As a result, there are seven positive signs, which suggests the presence of a stenotic process. The patient has constant vascular access - arteriovenous fistula, formed on March 22, 2009 in the distal third of the left forearm between a.radialis and the lateral vein of the v.cefalica basin. The patient underwent a clinical physical examination. Cartography of articularized veins was carried out, a possible section of stenotic changes was identified and indicated, an ultrasound study was recommended to confirm the diagnosis of stenosis, determine the level of localization in order to choose the tactics of patient management. At the next dialysis visit on 04.24.2012, the patient was diagnosed with arteriovenous fistula thrombosis before the planned ultrasound examination. The patient is urgently taken to the operating room. A transverse incision was made 2 cm from the arteriovenous anastomosis with a site of suspected stenosis. The presence of stenosis was confirmed intraoperatively, excision of this site was performed. Thrombectomy with a Fogarty catheter. Renal replacement therapy continued on reconstructed PSD.

In this case, also a complication of PSD, making it impossible to use it in the hemodialysis procedure, occurred before measures were taken to prevent stenosis. The application of the proposed diagnostic method did not allow to obtain a clinical effect, which is probably due to the late use of this method, a significant number of positively defined diagnostic signs indicating the severity of the process, and the lack of monitoring of all patients until the proposal of this diagnostic method.

Thus, the application of this approach, which includes accounting determined in a complex, in accordance with the protocol, is carried out on a monthly basis for all patients indices: average erythrocyte volume (MCV), average erythrocyte hemoglobin content (MCH), urea concentrations (Urea), urea at the end of dialysis (Ur_KT / V), urea mid-dialysis (Ur_PCR), as well as the performance of dialysis (Kt / V) and equilibrated _{Kt / V (Kt / V eqv} ), makes it possible to diagnose stenosis, arteriovenous fistula in the presence of four or more exponent beyond the specified limits: MCV> 93.3 fl, MCH> 32.2 pg / L, Urea> 15.9 mmol / L, Ur_KT / V> 4.2 mmol / L, Ur_jPCR> 4.5 mmol / L as well as Kt / V <1.71 units. and Kt / V _eqv <1.54 units. The effectiveness of the method is due to a comprehensive analysis of indicators, each of which is insufficient for an unambiguous interpretation of the results by diagnostic sensitivity and diagnostic specificity.

Claims (1)

A method for the diagnosis of arteriovenous fistula stenosis in patients with end-stage chronic kidney disease undergoing hemodialysis, including the determination of clinical, hematological and biochemical parameters, characterized in that they determine the level of mean red blood cell (MCV) values, the mean hemoglobin content in red blood cells ( MCH), concentrations of urea (Urea), urea at the end of dialysis (Ur_KT / V), urea in the middle of dialysis (Ur_PCR), dialysis efficacy indicators - Kt / V and equilibrated Kt / V (Kt / V _eqv ) and if there are at least four and their values: MCV> 93.3 fl, MCH> 32.2 pg / l, Urea> 15.9 mmol / l, Ur_KT / V> 4, 2 mmol / L, Ur_PCR> 4.5 mmol / L, and also Kt / V <1.71 units. and Kt / V _eqv <1.54 units, determine stenosis of arteriovenous fistula in these patients.