RU2736206C1 - Method for prediction of risk of permanent vascular access thrombosis within 6 months to 1 year in patients on program haemodialysis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to diagnostic methods in cardiovascular surgeons, nephrology and haemodialysis. Method for prediction of risk of permanent vascular access thrombosis within 6 months to 1 year in patients on program haemodialysis, includes recording the following patient data: the phosphorus level in the biochemical blood test, the supposed postoperative antibiotic therapy, blood urea level before and after haemodialysis session, presence of repeated operations on constant vascular access and their causes, erythropoietin dosage in complex therapy of anaemia, as well as determining the diameter of the fistulous vein when forming an anastomosis. Based on said data calculating prognostic coefficient, with values of which are equal to or greater than a certain value of cut-off point, higher risk of thrombosis of permanent vascular access within 6 months to 1 year is predicted.

EFFECT: use of the method enables minimizing the risk of permanent vascular access thrombosis by selecting an adequate therapeutic approach in the patients undergoing programmed haemodialysis.

1 cl, 1 tbl, 2 ex, 1 dwg

Description

The invention relates to medicine, namely to diagnostic methods in cardiovascular surgery, nephrology and hemodialysis.

There are methods for assessing the condition (Clinical guidelines "Treatment of patients with chronic kidney disease stage 5 (CKD 5) by hemodialysis and hemodiafiltration" / Association of Nephrologists, Russian Dialysis Society, Metropolitan Association of Doctors of Nephrologists. - M., 2016 - 30 p.) and the prognosis of thrombosis of permanent vascular access, largely due to the clinical picture (Moisyuk Y. G. / Permanent vascular access for hemodialysis // Moisyuk Y. G., Belyaev A. Yu.; - Tver: 2004. - 152 p.) or on based on resource-intensive procedures (David H. King / Volume blood now, static pressure ratio and venous conductance in native arterio-venous nstulae: three surveillance methods compared // David H. King, William D. Paulson, Mo Al-Qaisi et al // J Vase Access 2015; Vol 16, No. 3. P 211-217).

The disadvantage of these methods is low objectivity.

The closest analogue to the proposed solution (prototype) is a method for predicting the risk of formation of thrombosis of permanent vascular access within a period of up to 6 months in patients on programmed hemodialysis (RF patent No. 2711995). The essence of the method is that each hospitalized patient, upon admission to the hospital, records data on the concentration of blood glucose (GLK), alkaline blood phosphatase (ALP), blood potassium (CalC), blood phosphorus (PhosK), blood albumin (AlK) upon admission of the patient to the hospital, and also determine additional indicators: the estimated duration of anticoagulant therapy (DlA), the estimated correction of the dosage of anticoagulants (CorA), the proposed antibiotic therapy in the postoperative period (AB). Then the predictive coefficient (RTPSD ₆ ) is calculated as the classification value of the regression equation according to the formula:

RTPSD ₆ = constant + ZnP ₁ × GlC + ZnP ₂ × AFC + ZnP ₃ × CalC + ZnP ₄ × FosK + ZnP ₅ × AlK + ZnP ₆ × DlA + ZnP ₇ × CorA + ZnP ₈ × AB

and if the value of RTPSD _{6 is} greater than or equal to 0.17135424, then a high risk of thrombosis of permanent vascular access is predicted in the interval up to 6 months.

The disadvantage of this method is the small time interval of the forecast.

The purpose of our proposed method is to increase the duration of the prognosis of thrombosis of permanent vascular access. Based on multivariate statistical modeling, the following patient data are recorded: the level of phosphorus in the biochemical blood test (Phos), the proposed antibiotic therapy in the postoperative period (AB), the level of blood urea before (M ₀ ) and after a hemodialysis session (M ₁ ), which differs in that that the patient is determined by additional parameters: the diameter of the fistular vein during the formation of the anastomosis (DVen), the presence of repeated operations (Repeat) on the permanent vascular access and their causes (PR), and the dosage of erythropoietin in the complex therapy of anemia (Eryth), then the predictive coefficient is calculated (RTPSD ₁₂ ) as a classification value of the regression equation according to the formula: RTPSD ₁₂ = constant + ZnP ₁ × Fos + ZnP ₂ × AB + ZnP ₃ × M ₀ + ZnP ₄ × M ₁ + ZnP ₅ × DVen + ZnP ₆ × Repeat + ZnP ₇ × Cause + ZnP ₈ × Erit, where

the constant of this population = - 54.89547;

Phos - blood phosphorus level, mmol / l;

AB - the use of antibiotics in the postoperative period: 101 - no, 102 - yes;

M ₀ - the level of blood urea before the dialysis session, mmol / l;

M ₁ - blood urea level after dialysis session, mmol / l;

DVen - the diameter of the fistular vein during the formation of the anastomosis: 101 - less than or equal to 2 mm, 102 - more than 2 mm;

Repeat - the presence of repeated operations: 101 - no, 102 - yes;

Cause - the reason for repeated operations: 101 - thrombosis with stenosis, 102 - thrombosis with aneurysm;

Eryth - erythropoietin dosage: ME;

ZnP _{1 ... 8} - observed value for the corresponding variable:

ZnP ₁ = 2.31615000; ZnP ₂ = 4.18636000; SNP ₃ = 0.09826000;

SNP ₄ = 0.05341500; ZnP ₅ = - 0.27359000; SNP ₆ = 4.63464000;

ZnP ₇ = - 8.069600; ZNP ₈ = - 0.00023359;

and, if the value of RTPSD _{12 is} greater than or equal to 0.560079643, then a high risk of developing thrombosis of permanent vascular access is predicted in the interval from 6 months to 1 year.

The novelty of the proposed solution lies in the fact that for the first time in patients receiving treatment with programmed hemodialysis, thrombosis of permanent vascular access is predicted for a period of 6 months to 1 year by calculating the cut-off point and area under the curve at the corresponding values of sensitivity and specificity.

Technical solutions with features that coincide with the distinctive features of the proposed method have not been identified, which allows us to conclude that the proposed method meets the criterion of "inventive step".

In the process of developing the method, 168 patients receiving treatment with programmed hemodialysis were examined. The examination included obtaining anamnestic, physical, instrumental and laboratory data of the patient. The accounting was carried out according to some physical and laboratory data.

The data were processed using the statistical software package STATISTIC A StatSoA, Inc. (2014) (data analysis software system), version 12.5, and MedCalc Statistical Software version 15.8 (MedCalc Software bvba, Ostend, Belgium; 2015) on Windows.

Logistic regression and ROC analysis were used. It was possible to determine the most significant parameters dividing the sample into groups and making it possible to reveal the presence or absence of a risk for the development of thrombosis of permanent vascular access in a period from 6 months to 1 year in patients receiving programmed hemodialysis treatment. The logistic regression data for the data included in the model are displayed in Table 1.

The significance of the model was p <0.0001. Predictive power expressed by a concordance rate of 95.6%.

To predict the risk of formation of thrombosis of permanent vascular access in a period from 6 months to 1 year in treatment groups of patients, based on the data obtained, a logistic regression equation was created and solved:

RTPSD ₁₂ = constant + ZnP ₁ × Phos + ZnP ₂ × AB + ZnP ₃ × M ₀ + ZnP ₄ × M ₁ + ZnP ₅ × DVen + ZnP ₆ × Repeat + ZnP ₇ × Cause + ZnP ₈ × Erit, where

the constant of this population = - 54.89547;

Phos - blood phosphorus level, mmol / l;

AB - the use of antibiotics in the postoperative period: 101 - no, 102 - yes;

M ₀ - blood urea level before dialysis session, mmol / l;

M ₁ - blood urea level after dialysis session, mmol / l;

DVen - the diameter of the fistular vein during the formation of the anastomosis: 101 - less than or equal to 2 mm, 102 - more than 2 mm;

Repeat - the presence of repeated operations: 101 - no, 102 - yes;

Cause - the reason for repeated operations: 101 - thrombosis with stenosis, 102 - thrombosis with aneurysm;

Eryth - erythropoietin dosage: ME;

ZnP _{1 ... 8} - observed value for the corresponding variable:

ZnP ₁ = 2.31615000; ZnP ₂ = 4.18636000; SNP ₃ = 0.09826000;

SNP ₄ = 0.05341500; ZnP ₅ = - 0.27359000; SNP ₆ = 4.63464000;

ZnP ₇ = - 8.069600; ZNP ₈ = - 0.00023359;

and, if the value of RTPSD _{12 is} greater than or equal to 0.560079643, then a high risk of developing thrombosis of permanent vascular access is predicted in the interval from 6 months to 1 year

ROC analysis revealed that the sensitivity of the technique is 92.77%, and the specificity is 96.15%. The area under the characteristic curve was equal to 0.956, which indicated a good quality of the model. For practical purposes, the cut-off point was calculated; it turned out to be a level over 0.560079643. Youden's index was 0.8892. A plot of Sensitivity / 100-Specificity is shown in Figure 1.

Using the obtained cut-off point value when solving the presented equation in patients receiving treatment by programmed hemodialysis, the risk of thrombosis of permanent vascular access is minimized by choosing an adequate treatment method.

The proposed method is carried out as follows:

Each hospitalized patient, upon admission, records data on the level of phosphorus in a biochemical blood test (FOS), on the proposed antibiotic therapy in the postoperative period (AB), on the level of blood urea before (M ₀ ) and after a hemodialysis session (M ₁ ), the diameter of the fistula veins during the formation of an anastomosis (DVen), the presence of reoperations (Repeat) on a permanent vascular access and their causes (PR), and the dosage of erythropoietin in the complex therapy of anemia (Eryth). Then the predictive coefficient (RTPSD ₁₂ ) is calculated according to the formula: RTPSD ₁₂ = constant + ZnP ₁ × Phos + ZnP ₂ × AB + ZnP ₃ × M ₀ + ZnP ₄ × M ₁ + ZnP ₅ × DVen + ZnP ₆ × Repeat + ZnP7 × Cause + ZnP ₈ × Erit.

If the value of RTPSD _{12 is} greater than or equal to 0.560079643, then a high risk of thrombosis of permanent vascular access is predicted in the interval from 6 months to 1 year.

The proposed method is clearly illustrated by the following examples of its clinical use:

Example 1

Patient V., 62 years old. The main diagnosis Hypertension stage 3, risk 4. Primary nephrosclerosis. Chronic renal failure of the 5th stage. Requires treatment by programmed hemodialysis. The dialysis commission recommended the formation of a primary arteriovenous fistula. According to ultrasound data of the vessels of the left upper limb, the diameter of the radial artery in the lower third of the forearm is 2.6 mm, the middle third of the forearm is 2.8 mm, and the upper third of the forearm is 3.0 mm. The diameter of the cephalal vein in the lower third of the forearm is 3.0 mm, the middle third of the forearm is 3.2 mm, and the upper third of the forearm is 3.2 mm. Temperature 36.7 ° C degrees. Objectively: the skin and visible mucous membranes are of normal color and moisture. The chest is symmetrical, vesicular breathing in the lungs, no wheezing, respiratory rate 16 per minute. The heart sounds are muffled, rhythmic, heart rate 76-78 per minute, blood pressure 130/80 mm Hg. Other organs and systems were normal. ECG shows sinus rhythm, horizontal EOS. General clinical blood test on admission: erythrocytes 4.2 × 10 ¹² / l, HB 126 g / l, leukocytes 8.7 × 10 ⁹ / l, ESR 23 mm / h. Biochemical blood test: bilirubin 4.9 μmol / l, total protein 55.3 g / l, AcAT 12 U / l, AlAT 11.9 U / l, urea before dialysis 20.3 mmol / l, after 6.2 mmol / L, blood glucose 3.1 mmol / L, potassium 5.5 mmol / L, sodium 138 mmol / L, chlorine 101.2 mmol / L, alkaline phosphatase 80 U / L, albumin 42 g / L, phosphorus 1 , 7 mmol / l. The risk of thrombosis of permanent vascular access was assessed in the period from 6 months to 1 year by solving the logistic regression equation, taking into account the absence of repeated surgeries and the absence of antibiotic therapy at a prophylactic dosage in the postoperative period: RTSD ₁₂ = -54.89547 + 2.31615000 × 1 .7 + 4.18636000 × 101 + 0.09826300 × 20.3 + + 0.05341500 × 6.2 + (- 0.27359000) × 102 + 4.63464000 × 101 + (- 8.06961000) × 101 + (- 0.00023359) × 15 = - 0.52707

The obtained value does not exceed 0.560079643, which indicates that the risk of thrombosis of permanent vascular access in the period from 6 months to 1 year is low.

The calculation data were confirmed clinically, namely, by maintaining the patency of the arteriovenous fistula for 1 year without complications in the form of thrombosis.

Example 2

Patient Z., 60 years old. Main diagnosis Chronic glomerulonephritis with outcome in nephrosclerosis. Chronic renal failure stage 5. Requires treatment by programmed hemodialysis. The dialysis commission recommended the formation of a primary arteriovenous fistula. According to the ultrasound scan of the vessels of the left upper limb, the diameter of the radial artery in the lower third of the forearm is 2.6 mm, the middle third of the forearm is 2.7 mm, and the upper third of the forearm is 2.7 mm. The diameter of the cephalal vein in the lower third of the forearm is 3.0 mm, the middle third of the forearm is 3.0 mm, and the upper third of the forearm is 3.2 mm. The temperature is 36.6 ° C degrees. Objectively: the skin and visible mucous membranes are of normal color and moisture. The chest is symmetrical, vesicular breathing in the lungs, no wheezing, respiratory rate 16 per minute. Heart sounds are muffled, rhythmic, heart rate 76-80 per minute, blood pressure 130/80 mm Hg. Other organs and systems were normal. ECG shows sinus rhythm, horizontal EOS. General clinical blood test on admission: erythrocytes 3.1 × 10 ¹² / l, HB 110 g / l, leukocytes 8.0 × 10 ⁹ / l, ESR 15 mm / hour. Biochemical blood test: bilirubin 5.9 μmol / L, total protein 60.2 g / L, AST 15 U / L, ALAT 12.9 U / L, urea before dialysis 27.3 mmol / L, urea after dialysis 9, 9 mmol / L, blood glucose 6.5 mmol / L, potassium 7.7 mmol / L, sodium 140 mmol / L, chlorine 100 mmol / L, alkaline phosphatase 168 U / L, albumin 39 g / L, phosphorus 2, 45 mmol / l. The risk of thrombosis of permanent vascular access was assessed in the period from 6 months by solving the logistic regression equation, taking into account the absence of repeated surgeries and the absence of antibiotic therapy at a prophylactic dosage in the postoperative period:

RTPSD ₁₂ = -54.89547 + 2.31615000 × 2.45 + 4.18636000 × 101 + 0.09826300 × 27.3 ++ 0.05341500 × 9.9 + (-0.27359000) × 102 + 4, 63464000 × 101 ++ (- 8.06961000) × 101 ++ (- 0.00023359) × 3500 = 1.268238.

The obtained value exceeds 0.560079643, which indicates that the risk of thrombosis of permanent vascular access in the period from 6 months to 1 year is high.

The calculation data were confirmed clinically, namely, the absence of patency of the arteriovenous fistula for 1 year with complications in the form of thrombosis at 7 months of functioning. The patient required surgical treatment in the form of an arteriovenous fistula in the upper third of the forearm.

The proposed method is applied in the department of vascular surgery GBUZ YaO "Regional clinical hospital" "to predict the risk of thrombosis of permanent vascular access in the period from 6 months to 1 year.

Claims (21)

A method for predicting the risk of formation of thrombosis of permanent vascular access in the period from 6 months to 1 year in patients on programmed hemodialysis, which consists in taking into account the following patient data upon admission to the hospital: the level of phosphorus in the biochemical blood test (FOS), the proposed antibiotic therapy in the postoperative period (AB), the level of blood urea before (M ₀ ) and after a hemodialysis session (M ₁ ), characterized in that additional parameters are determined in the patient: the diameter of the fistular vein during the formation of the anastomosis (DV), the presence of repeated operations (Repeat) on the permanent vascular access and their causes (PricO),) and the dosage of erythropoietin in the complex therapy of anemia (Eryth), then the prognostic coefficient (RTSD ₁₂ ) is calculated as the classification value of the regression equation by the formula: RTPSD ₁₂ = constant + ZnP ₁ × Phos + ZnP ₂ × AB + ZnP ₃ × M ₀ + ZnP ₄ × M ₁ + ZnP ₅ × DVen + ZnP ₆ × Repeat + ZnP ₇ × Cause + ZnP ₈ × Erit, where the constant of this population = - 54.89547; Phos - blood phosphorus level, mmol / l; AB - the use of antibiotics in the postoperative period: 101 - no, 102 - yes; M ₀ - the level of blood urea before the dialysis session, mmol / l; M ₁ - blood urea level after dialysis session, mmol / l; DVen - the diameter of the fistular vein during the formation of the anastomosis: 101 - less than or equal to 2 mm, 102 - more than 2 mm; Repeat - the presence of repeated operations: 101 - no, 102 - yes; Cause - the reason for repeated operations: 101 - thrombosis with stenosis, 102 - thrombosis with aneurysm; Eryth - erythropoietin dosage: ME; ZnP _{1 ... 8} - observed value for the corresponding variable: ZnP ₁ = 2.31615000; ZnP ₂ = 4.18636000; SNP ₃ = 0.09826000; SNP ₄ = 0.05341500; ZnP ₅ = - 0.27359000; SNP ₆ = 4.63464000; ZnP ₇ = - 8.069600; ZNP ₈ = - 0.00023359; and if the value of RTPSD _{12 is} greater than or equal to 0.560079643, then a high risk of thrombosis is predicted.

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