Method of predicting risk of glomerular filtration rate reduction after aortocoronary bypass surgery on working heart

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to a method of predicting a probability of reduction of the glomerular filtration rate (GFR) after 3 months of observation after aortocoronary bypass surgery without artificial blood circulation (ACBS without ABC). The essence of the method consists in the fact that the concentration of a kidney injury molecule of type 1 (KIM-1) is determined in blood serum, the ratio of the biomarker KIM-1 concentrations in two time points after 48 hours and 7 days after the operation is calculated and if its value is higher than 1.5, a conclusion about the probability of (GFR) reduction in the remote period after ACBS without ABC is made.

EFFECT: application of the claimed method makes it possible to predict the probability of the glomerular filtration rate (GFR) reduction after 3 months of observation after aortocoronary bypass surgery without artificial blood circulation in an efficient and accurate way.

1 tbl, 1 dwg, 1 ex

 

The invention relates to medicine, namely to surgery and Nephrology, and can be used in the departments of cardiac surgery, therapy, as well as in outpatient clinics (outpatient medical care).

Coronary artery bypass grafting (CABG) has established itself as an effective method of treatment of coronary heart disease (CHD). Procedure on a beating heart without cardiopulmonary bypass, without IR) is considered preferable because of the smaller risk of developing acute kidney injury (AKI), systemic inflammatory response and other adverse effects of IR [1-3]. The search for early predictors of AKI after cardiac surgery and to assess their informativeness in comparison with the classical marker of renal function - serum creatinine (TFR) [4-6]. Based on the values of the TFR one of the estimated means estimated glomerular filtration rate (GFR). Alternatively, the TFR and GFR are studied biomarkers: cystatin C, interleukin-18, kidney injury molecule type 1 (kidney injury molecule-1 KIM-1) and others [7-9]. It should be noted that in most studies the observation period is limited to 48 to 72 hours of the postoperative period [11, 12], i.e. as the time point chosen point of diagnosis of AKI. Information about the dynamics functions almost�to the long period of observation (months - years) in patients undergoing CABG without IR, almost never occur, despite the fact that the presence of chronic kidney disease associated with increased cardiovascular risk and reduces the lifespan. KIM-1 is a surface protein of the immunoglobulin superfamily, is localized predominantly in the apical membrane of proximal epithelial cells is recognized as one of the most sensitive markers of AKI [5, 12]. After damage to renal tubular KIM-1 begins to be excreted with the urine. Investigated the concentration of KIM-1 in urine and serum [13]. High levels suggest an adverse outcome of AKI [14]. In addition, KM-1 impact on preserving the viability of epithelial cells and turns them into phagocytes, able to absorb dead cells, which greatly speeds up the process of recovery of renal function [15]. Thus, KIM-1 is not only a diagnostic marker, but also increases the intensity of the processes of recovery of the structure and function of the renal tissue. Data on the dynamics of the levels of KIM-1 and their prognostic value in long-term monitoring of renal function after specific techniques CABG without IR is very limited.

Objective: to evaluate the possibility of using early postoperative level of KIM-1 as biomarker for prediction of GFR decline che�ez 3 months of follow-up after CABG without IR.

Based on the research model developed a method of predicting deterioration in renal function (decrease GFR) in the remote period after CABG without PC. The analogue of the developed model is the work of [9], which the authors suggest the use of early postoperative levels of KIM-1 and hepatic protein associated with fatty acids (liver fatty acid-binding protein, L-fabp gene) to predict AKI after cardiac surgery (not only after isolated CABG techniques without IR). The analogue model is based on the levels of 2 biomarkers (KIM-1 and L-fabp gene) measured in the first 6-12 hours after surgery, that is more time-consuming. Dunn model involves the measurement of a single biomarker KIM-1 in two points. The area under the ROC curve of the model-equivalent to 0.78, while for the author of the model area is 0,818, which means that the latter has a greater predictive power. Besides the authors of the analog propose a method for predicting AKI (develops within 48-72 hours after surgery), not considering the long-term dynamics of renal function. The proposed prediction method is aimed at assessing the risk of deterioration in renal function (decrease GFR) in the long period of follow-up after CABG without IR.

Description of the method: to determine the risk of an impaired GFR at 3 months after CABG without IR 48 hours � 7 days after surgery to determine the serum level of KIM-1 and the ratio of the levels of KIM-1 in the above points and if you value this relationship more than 1.5 make a conclusion about the risk of decline in GFR after 3 months, that is about the risk of distant worsening of renal function. Prediction probability (sensitivity 82%, specificity of the method was 81%. The predictability of a positive test result 58%. The predictability of a negative test result 80%. Likelihood ratio for a positive result is 4.3.

Positive effect: prediction of GFR decline allows in the early postoperative period to allocate the risk group for targeted monitoring of threatened patients after CABG without IR, regular assessment of renal function is available for outpatient methods (levels of TFR and GFR) and when indicated in a timely manner to refer patients for a consultation with a nephrologist. When using the proposed method of risk assessment in the specified group may be prescribe drugs with nephroprotective properties and to avoid unreasonable prescription of nephrotoxic funds. For example, after cardiac surgery are often prescribed an antibacterial agent that can reduce GFR, especially in patients with compromised renal function (aminoglycosides, and some cephalosporins). In this case, it is possible to avoid unreasonable prescription of medicines or the use of less nephrotoxic funds. When disturbed function almost�to undesirable assignment potassium-sparing diuretics (spironolactone). When the need for diuretics is at risk, you should use a loop or thiazide diuretics. An indication of the risk of an impaired GFR at discharge from the Department of cardiac surgery may be useful for alertness outpatient clinics in terms of a possible deterioration in renal function remote period after CABG surgery without IR. In addition, information about possible reductions in GFR after CABG without ROS will be useful for secondary prevention of coronary heart disease, since the development of CKD and the growing severity indicates an increase in cardiovascular risk.

Material and methods. The study included 30 patients with ischemic heart disease, including 23 men (76.7 percent) and 7 women (23.3 percent) who had undergone isolated CABG without IR, mean age 57.9±4.7 years.

After 48 hours and 7 days after CABG without IR were measured the levels of TFR and GFR according to standard procedures. At the same time points by ELISA using commercial reagents were determined serum levels of KIM-1. On the basis of the TFR 48 hours after CABG without IR AKI was diagnosed in 3 cases (10%). The decrease in GFR at 3 months after surgery occurred in 11 patients (36,7%), i.e. every 3-4th. The initial level of KIM-1 was 30.8 (11,0-65,6) ng/ml.

It was calculated the ratio of the concentrations of KIM-1 after 48 hours and 7 days after CABG without IR: KIM-148 hours/KIM-17 �it - Method of constructing ROC curves is determined that the value of this ratio of 1.5 and above with a sensitivity of 82% and specificity of 81% to predict the decrease in GFR at 3 months after CABG without IR (Fig.1). The decrease in GFR - 17.3 ml/min/1.73 m2(17%) (95% CI 8-26), t (3, 27)=4,22, p=0.001.

The data obtained confirms the method of logistic regression: the attitude of KIM-148 hours/KIM-17 dayswas a predictor of outcome (GFR decrease/increase) after 3 months of observation after surgery (table 1).

Table 1.
Predictors of GFR change (decrease/increase) 3 months after CABG without IR (n=27)
B(SE)95% CI for the odds ratio (OR)P
BottomOSHTop
Constant2,064 (0,829)0,013
KIM-148 hours/KIM-17 days-0,940 (0,428)0,169 0,3900,9030,028
Note. To reduce GFR: R2=0,285 (Cox and Snell); R2=0,385 (Nagelkerke). Model χ2=9,062, p=0.003

Clinical example of the use of the method

Patient M., 54 years old, suffering from coronary heart disease, surgery performed isolated CABG without IR in the cardiac surgery Department of pathology Department of the Arkhangelsk region "the First city clinical hospital named. E. E. Volosevich" in 2012.

Baseline renal function was normal with the levels of TFR and GFR 82,0 µmol/l and 90,4 ml/min/1.73 m2respectively. The level of KIM-1 was determined in the serum during the day before surgery (to 57.2 ng/ml) and 48 hours (101,9 ng/ml) and 7 days (24,0 ng/ml) after CABG without IR. The attitude of KIM-148 hours/KIM-17 gnawpatient M. was 4.25, we have exceeded the proposed diagnostic value (1,5), on what basis it was concluded that the risk of an impaired GFR at 3 months after surgery.

This forecast was confirmed. After 3 months of observation in the clinic has seen a worsening of renal function: GFR decline by 16.7 ml/min/1.73 m2(18.5%), - actual GFR amounted to 73.7 ml/min/1.73 m2.

This clinical case confirms the positive effect when using the proposed method.

Relative�Linux serum concentrations of KIM-1, defined in 48 hours and 7 days after surgical treatment, can be used as a marker for determining the risk of an impaired GFR in the remote period after CABG without IR.

The list of sources

1. Nigwekar SU, Kandula P, Hix JK et al. Off-pump coronary artery bypass surgery and acute kidney injury: a meta-analysis of randomized and observational studies. American Journal of Kidney Diseases 2009; 54(3): 413-423.

2. Massoudy P, Wagner S, Thielmann M, et al. Coronary artery bypass surgery and acute kidney injury - impact of the off-pump technique. Nephrology, Dialysis and Transplantation 2008; 23 (9): 2853-2860.

3. Nair S, Iqbal K, Phadke M et al. Effect ofcardiopulmonary bypass on tissue injury markers and endothelial activation during coronary artery bypass graft surgery. Journal Postgraduate Medicine 2012; 58 (1): 8-13.

4. Eren Z, Ozveren O, Buyukoner E et al. A Single-centre study of acute cardiorenal syndrome: incidence, risk factors and consequences. Cardiorenal Medicine 2012; 2: 168-176.

5. Huo W, Zhang K, Nie Z et al. Kidney injury molecule-1 (KIM-1): a novel kidney-specific injury molecule playing potential double-edged functions in kidney injury. Transplantation Reviews 2010; 24: 143-146.

6. Sprenkle P, Russo P. Molecular markers for ischemia, do we have something better then creatinine and glomerular filtration rate? Arch Esp Urol 2013; 66(1): 99-114.

7. Che M, Xie B, Xue S et al. Clinical usefulness of novel biomarkers for the detection of acute kidney injury following elective cardiac surgery. Nephron Clinical Practice 2010; 115: 66-72.

8. Tsigou E, Psallida V, Demponeras C et al. Role of new biomarkers: functional and structural damage. Crit Care Res Pract 2013 February 5: [Epub ahead of print].

9. Parikh CR, Thiessen-Philbrook H, Garg AX et al. Performance of kidney injury molecule-1 and liver fatty acid-binding protein and combined biomarkers of AKI after cardiac surgery. Clin J Am Soc Nephrol 2013 Apr 18. [Epub ahead of print].

10. Sidebotham D. Novel biomarkers for cardiac surgery-associated acute kidney injury: a skeptical assessment of their role. J Extra Corpor Technol 2012; 44 (4): 235-240.

11. Han WK, Wagener G, Zhu Y et al. Urinary biomarkers in the early detection of acute kidney injury after cardiac surgery. Clin J Am Soc Nephrol 2009; 4 (5): 873-882.

12. Huo W, Zhang K, Nie Z et al. Kidney injury molecule-1 (KIM-1): a novel kidney-specific injury molecule playing potential double-edged functions in kidney injury. Transplantation Reviews 2010; 24: 143-146.

13. Han WK, Bailly V, Abichandani R, et al. Kidney Injury Molecule-1 (KIM-1): a novel biomarker for human renal proximal tubule injury. Kidney Int 2002; 62(1): 237-44.

14. Liangos O, Perianayagam MC, Vaidya VS, et al. Urinary N-acetyl-beta-(D)-glucosaminidase activity and kidney injury molecule-1 level are associated with adverse outcomes in acute renal failure. J Am Soc Nephrol 2007; 18 (3): 904-912.

15. Ichimura T, Asseldonk EJ, Humphreys BD et al. Kidney injury molecule-1 is a phosphatidylserine receptor that confers a phagocytic phenotype on epithelial cells. J Clin Invest 2008; 118 (5): 1657-1668.

A method of predicting the likelihood of a reduction in glomerular filtration rate (GFR) after 3 months of follow-up after coronary artery bypass grafting without extracorporeal circulation (CABG without IR), including the determination of the concentration of biomarker of kidney injury molecule type 1 (KIM-1), characterized in that in the serum to determine the concentration of KIM-1, calculate the ratio of concentrations of the biomarker KIM-1 in two time points after 48 h and 7 days after surgery and when the value of more than 1.5 predict the likelihood of decreased GFR in the remote period after CABG without IR.



 

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