Screening diagnostic technique for arteriovenous fistula stenosis in patients with end-stage chronic renal disease

IPC classes for russian patent Screening diagnostic technique for arteriovenous fistula stenosis in patients with end-stage chronic renal disease (RU 2508544):

G01N33/48 - Biological material, e.g. blood, urine (G01N0033020000-G01N0033140000, G01N0033260000, G01N0033440000, G01N0033460000 take precedence;determining the germinating capacity of seeds A01C0001020000); Haemocytometers (counting blood corpuscules distributed over a surface by scanning the surface G06M0011020000)

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FIELD: medicine.

SUBSTANCE: patients being treated by program hemodialysis is analysed for a complex of blood thrombocytes (X₁, ×10⁹/_l), urea concentration (X₂,^mole/_l), phosphor concentration (X₃, ^mole/_l), transferrin concentration (X₄, ^g/_l), calcium concentration (X₅, ^mole/_l) in blood serum, and a dialysis effectiveness coefficient Kt/V_equ (X₆, units), and then a discriminant function (DF) is calculated by formula. If the derived DF value is positive, the presence of arteriovenous fistula stenosis is diagnosed.

EFFECT: using the declared technique enables diagnosing the presence or absence of any stenosis changes in an arteriovenous fistula with a probability of more than 95 percent without additional laboratory and clinical studies that enable projecting a minimum surgical repair as may be necessary.

3 ex

The alleged invention relates to medicine and can be used in Nephrology during renal replacement therapy (RRT) in patients with end-stage chronic kidney disease.

In the past decade and a half in the world among the adult population stated pandemic of chronic kidney disease (CKD). In Russia, the number of patients in need of carrying out STA, in 1998, was 8228 people, and in 2009 - 24195 people (170,5 per million population). The majority of patients receiving OST in modality "software hemodialysis" (PGD) - in vitro method for purifying the blood. It accounts for up to 85% of patients. In 2009 OST PGD received 17324 person (122 per million population) [Bikbov BT, Tomilin N. State replacement therapy in patients with chronic renal failure in Russia in 1998-2009, (Report according to the Russian register of renal replacement therapy) / Nephrology and dialysis - 2011 - V.13. No. 3 - C.152-250].

The adequacy of replacement therapy carried out by a method of software hemodialysis, is impossible without a well-functioning permanent vascular access (PDS). With these requirements in mind "vascular access first choice" remains a fundamental development V.J. Brescia and J.E. Cimino (1966) - the operation of creating a subcutaneous arteriovenous fistula (AVF) [European Best Practice Guidelines fr Haemodialysis (Part 2) / Nephrol Dial Transplant, - 2007. - V.22 [Suppl 2] //http://www.oxfordjoumals.org/ourjoumals/ndt/eraedta.html]. Complications associated with a permanent vascular access (PDS)are a major cause of morbidity, hospitalization and increased cost of treatment of patients under PGD. For treatment of these complications account for a quarter of the total duration of hospitalization of patients and appreciation of 50% of the cost of hospital therapy [Rodriguez J.A., Armadans L., Ferrer E., et al. The function of permanent vascular access / Nephrol. Dial. Transplant - V.2000 - P.402-408.].

One of the main complications after creating AVF is stenosis, which somehow leads to thrombosis of the PDS. At the same time, according to the Russian registry of renal replacement therapy thrombosis recorded almost every tenth patient under software hemodialysis [Bikbov BT, Tomilin N. State replacement therapy in patients with chronic renal failure in Russia in 1998-2009, (Report according to the Russian register of renal replacement therapy) / Nephrology and dialysis. - 2011. - V.13. No. 3. - S-250].

Active management of the functioning of accesses with priority maximum sparing use of their potential with correction of problems such as thrombosis or ineffective functioning is among the three most important criteria for assessing the quality of surgical services dialysis centers [esarab A. Preventing vascular access dysfunction: which policy to follow. Blood Purif. 2002; 20(1): 26-35].

Stenosis of arteriovenous fistula (AVF) - acquired persistent narrowing of the lumen of the blood vessel, leading to slow blood flow above the stenosis and the local acceleration of blood flow in stenotic area, associated with the presence of one or more areas of endothelial and massive fibro muscular hyperplasia. The development of subclinical and then clinically significant stenosis leads to a violation of the achieved homeostasis and causes thrombosis PDS more than 80% of patients, which remains a major complication requiring urgent endovascular interventions.

Thus, a screening diagnosis of stenosis can provide early detection of signs of stenotic changes and the timely use of less aggressive treatment that will help reduce the economic cost of treatment of such patients and, consequently, improve the quality of their treatment.

Similar to the proposed method of early diagnostics is conducting angiographic studies. The disadvantage of this method is the radial load, preventing frequent research, the need for contrast administration, and contraindications allergic reaction to iodine preparations, the high costs of research and the availability of the difference is the main complication after carrying out angiography 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.]

The closest analogue of the proposed method for early diagnosis of restenosis PDS in patients with chronic kidney disease, including software hemodialysis may be considered a method of magnetic resonance tomography [Froger CL, Duijm LE, Liem YS et al. Stenosis detection with MR angiography and digital subtraction angiography in dysfunctional hemodialysis access fistulas and grafts. Radiology 2005; 234: 284-291], but it cannot be considered as a screening method for diagnosis because of the high cost and the long duration of the survey.

The tasks of the proposed method are providing early. diagnosis the development of stenosis, the reduction in the incidence of thrombotic complications PDS resulting from stenosis in patients on chronic hemodialysis, increasing treatment effect.

Screening diagnosis has reduced the frequency of thrombotic complications in consequence of stenosis of AVF, to provide early diagnosis development of stenosis, to reduce the period of medical-social rehabilitation of patients. The accuracy of the proposed method (p<0,05).

The invention consists in that, for a screening diagnosis of stenosis of arteriovenous fistula in patients with end-stage chronic kidney disease, are on the program is mnom hemodialysis, the complex determine the content of platelets in the blood (X1, ×10⁹/l), concentration of urea (x2, mmol/l), phosphorus (X3, mmol/l), the concentration of transferrin (X4, g/l), calcium concentration (X5, mmol/l) in serum and efficiency dialysis Kt/V (X6, u) and then calculate the value of the discriminant functions (DF), by the formula:

DF=19,96-0,01×X1+0,20×x2-1,81×X3+1,51×X4-3,66×X5-to 8.57×X6,

if a positive value of the discriminant functions diagnose the presence of stenosis in arteriovenous stula.

Blood sampling the study was conducted from fistulas needle after puncturing PDS directly as before the procedure, DG for research most of the indicators), and after (to study the level of urea at the end of dialysis). The analysis of both samples is carried out in the same analytical series. Measurement of platelet count in the blood (X1, ×10⁹/l) is carried out using the automatic conductometric: count in whole blood stabilized K₃_-EDTA (Auto Hematology analyzer Sysmex XS-1000"). The concentration of urea (x2, mmol/l) in serum before DG and at the end of the DG procedure for calculating the efficiency of dialysis Kt/V (X6, u) to the urea, the method Daugirdas JT: 1995; the concentration of phosphorus (X3, mmol/l) in the reaction with heptamolybdate (reagents Beckman Coulter, Inc.). Concentration is the situation transferrin (X4, g/l) determined by the method of: immunoturbidimetry with multipoint calibration (reagents Beckman Coulter, Inc). The concentration of calcium (X5, mmol/l)serum define photometric test with arsenazo-III (reagents Beckman Coulter, Inc). All biochemical studies are carried out on an automatic biochemical analyzer Olympus AU 640". The obtained values are substituted into the formula: DF=19,96-0,01×X1+0,20×x2-1,81×X3+1,51×X4-3,66×X5-to 8.57×X6, and in the case of a positive result are diagnosed with stenosis of arteriovenous fistula.

When testing techniques in patients receiving replacement therapy, were tasked with identifying stenosis PDS, confirmation of the diagnosis using ultrasound examination, and during surgical intervention. Validation of the method was conducted in 50 patients, for which the calculated DF, positive values of DF is defined in 15. All of them held ULTRASONIC study reconfirmed the diagnosis in all 15 patients, and 8 of them are diagnosed with hemodynamically significant stenosis. Routinely these 8 patients were operated. Intraoperative diagnosis underwent surgical correction of hemodynamically significant stenosis, with priority to the most sparing use of the potential of the PDS. These patients continued OST on the same vascular access, thus avoiding the use of venous catheters as soudes is on access and thus, to prevent the development of stenosis of the Central veins. Thus, the correct conclusion about the presence of stenosis of arteriovenous fistula obtained in 100% of cases.

Is being treated with hemodialysis program with 07/07/2004 present. Main diagnosis: chronic glomerulonephritis. Complications primary: end-stage renal failure. Concomitant chronic viral hepatitis b without Delta-agent.

During the examination the patient 13.02.2012 obtained the following results: platelets in the blood 201×10⁹/l, the concentration of the urea of 23.9 mmol/l, the phosphorus concentration of 1.16 mmol/l, the concentration of transferrin 1,72 g/l, the concentration of calcium in the serum of 2.1 mmol/l and the coefficient of efficiency dialysis Kt/Wakw 1,ed. The calculation of the discriminant function gave a result DF=19,96-0,01×201+0,20×23,9-1,81×1,16+1,51×1,72-3,66×2,1-8,57×1,72=+0,81, which indicates the presence of stenosis of arteriovenous fistula. Retrospective analysis using DF revealed the long existence of the inverted values 16.01.2012 year DF=+1,52. The patient has a permanent vascular access arteriovenous fistula formed 20.04.2004 in the distal third of the left preplace between a. radialis and lat the Central Vienna basin v. cefalica. The patient performed a clinical physical examination, taking into account the constitutional type, prolonged patient at OST and, as a consequence, the presence of complications PDS in the form aneurysms. Conducted mapping arteriotony veins, defined and identified possible areas of stenotic changes recommended by ultrasound scanning to confirm the diagnosis of stenosis, determine the level of localization, with the aim of tactics choice of the patient. When ultrasound study 17.02.2012 (ACUSON ASPEN, USA) revealed the tortuous nature of the course arteriotony veins, the presence of multiple areas of narrowing of the lumen and the local increase of the linear velocity of blood flow. Found aneurysmal expansion with parietal mass, collateral type of blood flow in the proximal part of the venous network in postunification area in the middle and upper third of the forearm.

Planning operational benefits in the amount of implantation of the vascular prosthesis. Made a transverse incision at 3 cm from the arteriovenous anastamosis on the first site of the stenosis. Intraoperatively confirmed the presence of stenosis performed excision of this area. Implantion linear vascular prosthesis on the forearm between arteriotony lateral Vienna basin v. cefalica and v. basilica in the lower third of the shoulder, allowing the use of it in image quality is as PDS after 24 hours (Vascutec Rapidax). Renal replacement therapy is continued on the reconstructed PSD. In this case, the proposed method allowed to detect stenotic changes PDS, to conduct timely differential correction hemodynamically significant stenosis prior to the development of thrombotic complications, allowed to exclude using venous catheter as vascular access in the postoperative period.

Is being treated with hemodialysis program with 02/12/2009 at the present time. Main diagnosis: polycystic kidney disease. The complication of primary: secondary chronic pyelonephritis, latent, end-stage renal failure, extracorporeal dialysis.

During the examination the patient 16.03.2012 obtained the following results: platelets in the blood 228×l0⁹/l, the concentration of urea to 31.5 mmol/l, the phosphorus concentration of 1.25 mmol/l, the concentration of transferrin 1,60 g/l, the concentration of calcium in serum 2,11 mmol/l and the coefficient of efficiency dialysis Kt/V 1,51 units Calculating discriminant functions gave the DF=19,96-0,01×228+0,20×31,5-1,81×1,25+1,51×1,6-3,66×2,11-8,57×1,51=+3,47, which indicates the presence of stenotic process. In a retrospective analysis On the identified long-term existence of inverted values, 13.02.2012 DF=+5,98; 16.01.2012, DF=+1,79. The patient has a permanent vascular access arteriovenous fistula formed 06.04.2010 in the distal third of the right forearm between a. radialis and lateral Vienna basin v. cefalica. The patient performed a clinical examination. Given the constitutional type, prolonged patient at OST and, as a consequence, highly probable complications PDS in the form aneurysms, held cartography arteriotony veins, defined and identified possible areas of stenotic changes recommended by ultrasound scanning to confirm the diagnosis of stenosis, determine the extent and level of localization, with the aim of tactics choice of the patient. When ultrasound study 03.04.2012 g (Apparatus Sono Scape SSI 6000) identified: the site of the narrowing of the lumen and the local increase of the linear velocity of blood flow, aneurysmal expansion without parietal mass, a mixed type of blood flow in the proximal part of the venous network in postunification area in the middle and upper third of the forearm.

Planned and conducted (03.05.2012) operational manual. Made a transverse incision at 6 cm from the arteriovenous anastamosis for the site of stenosis, confirmed the presence of stenosis in the projection of the valve lateral veins pool v. cefalica made operational manual: the Fogarty catheter control patency Proxima is inogo Department v. cefalica and v. basilica; the proximal reanastamosis. Renal replacement therapy is continued on the reconstructed PSD. In this case, the proposed method allowed to detect stenotic complications PDS, to conduct timely differential correction hemodynamically significant stenosis prior to the development of thrombotic complications and allowed to exclude using venous catheter as vascular access in the postoperative period, which is the prevention of the development of stenotic complications of Central vein.

Is being treated with hemodialysis program with 04/02/2012 at the present time. Main diagnosis: insulin-dependent diabetes mellitus. The main complication: diabetic nephropathy, end-stage renal failure, extracorporeal dialysis, diabetic microangiopathy, diabetic neuropathy. Related: secondary hypertension, chronic viral hepatitis b, obesity.

During the examination the patient 13.03.2012 obtained the following results: platelets in the blood 165×10⁹/l, the concentration of urea to 19.3 mmol/l, the phosphorus concentration of 1.39 mmol/l, the concentration of transferrin of 2.45 g/l, the concentration of calcium in the serum of 2.1 mmol/l and the coefficient of efficiency dialysis Kt/V 1,ed. The calculation of the discriminant function gave a result DF=19,96-0,01×165+0,20×19,3-1,81×1,39+1,51×2,45-3,66×2,16-8,57×1,06=+6,36, indicating the presence of stenotic process. Retrospective analysis using DF revealed the existence of inverted values in the previous study. The patient has a permanent vascular access arteriovenous fistula formed 01.11.2011, in the distal third of the left preplace between a. radialis and lateral Vienna basin v. cefalica. The patient performed a clinical examination. Given the constitutional type, nondurable when the patient is on SMT conducted cartography arteriotony veins, defined and identified a possible site of stenotic changes recommended by ultrasound scanning to confirm the diagnosis of stenosis and to determine the level of its location, to choose the tactics of the patient. Ultrasound (29.03.2012, ultrasound scanner ALOCA 5500) identified: direct move arteriotony veins, the site of the narrowing of the lumen in the area of arteriovenous anastomosis and the local increase of the linear velocity of blood flow, aneurysmal extension no backbone modified type of blood flow in the venous network, no signs of thrombosis.

Planning operational benefits in the volume holding the proximal reanastamosis. The operational allowance is made 11.04.212 of the longitudinal incision 6 cm above the arteriovenous anastomosis. Confirmed the presence of stenosis in 1 cm from anastamose performed excision of the stenotic area arteriotony Vienna, conducted by monitoring the patency of the proximal v. cefalica and v. basilica, a Fogarty catheter; operation volume - reanastomosed using part of the vascular prosthesis. Renal replacement therapy is continued on the reconstructed PSD. The use of diagnostic screening allowed us to identify stenotic complications of AVF, to conduct timely differential correction hemodynamically significant stenosis prior to the development of thrombotic complications, to exclude using venous catheter as vascular access in the postoperative period.

Method of screening for diagnosing stenosis of arteriovenous fistula in patients with end-stage chronic kidney disease, including software hemodialysis, characterized in that in combination determine the content of platelets in the blood (X₁, ·10⁹/_l), the concentration of urea (X₂,^mmol/_l), the concentration of phosphorus (X₃,^mmol/_l), the concentration of transferrin (X₄,^g/_l), calcium concentration (X₅,^mmol/_l) in serum and efficiency dialysis Kt/V_EQ(X₆, ed) and then determine the value of the discriminant function is tion (DF) using the formula:
DF=19,96-0,01·X₁+0,20·X₂-1,81·X₃+1,51·X₄-3,66·X₅-8,57·X₆,
and positive value DF diagnose the presence of stenosis in arteriovenous fistula.