RU2801159C1 - Method of predicting an increased risk of a complicated course of the early postoperative period in patients with ischemic cardiomyopathy at the preoperative stage - Google Patents

Abstract

FIELD: medicine, radionuclide diagnostics in cardiology.

SUBSTANCE: invention can be used to predict the development of a complicated course of the early postoperative period in patients with ischemic cardiomyopathy at the preoperative stage. Echocardiography (EchoCG) is performed and the final systolic volume of the left ventricle (LV systolic volume) is determined. Radionuclide equilibrium ventriculography with 99mTc-pyrophosphate is conducted at rest and against the backdrop of successive intravenous infusions of dobutamine at doses of 5, 10, 15 mcg/kg/min for 5 minutes for each dose. LV Entropy is determined at rest and LV Entropy is determined at the peak of the stress test. The prognostic probability of developing a complicated course of the early postoperative period in patients with ischemic cardiomyopathy (P) is calculated using the following formula: Р=1/(1+e^{(-(-7.64+2.82*Х-0.23× Y+0.03*Z))} where X is equal to 1 if the patient has an operation on the mitral valve, equals to 0 if the patient does not have an operation on the mitral valve; Y is LV ΔEntropy calculated by the formulaΔ LV Entropy = (LV Entropy at peak stress test - LV Entropy at rest); Z is LV CSR. If the P value is greater than 0.5, the development of complications in the early postoperative period after surgical treatment of ischemic cardiomyopathy is predicted.

EFFECT: method enables to select the patients with an increased risk of developing cardiovascular complications in the early postoperative period due to echocardiographic and radionuclide signs.

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Description

The invention relates to medicine, namely to radionuclide diagnostics in cardiology, and is intended to identify patients with an increased risk of a complicated course of the early postoperative period after surgical treatment of ischemic cardiomyopathy (ICMP) in order to improve the selection of patients for this type of treatment and the choice of tactics for their management in the postoperative period. The method can be used in cardiology departments of medical diagnostic institutions equipped with radioisotope laboratories.

It is known that coronary heart disease (CHD) remains one of the main causes of death and disability in the world, as well as one of the main factors in the development of chronic heart failure [1]. The progression of coronary artery disease, accompanied by an expansion of the cavities of the heart and severe contractile dysfunction, is called ICMP [2]. This condition is associated with the worst prognosis in comparison with other variants of IHD [3]. In the course of a large number of studies, it has been demonstrated that surgical treatment of this pathology has a significantly better result compared to the use of conservative therapy [4]. However, since this type of treatment always involves open and prolonged surgery, some patients in the early postoperative period experience a number of severe complications associated with impaired inotropic function of the heart [5-7].

Thus, there is a need to assess the likelihood of complications in the early postoperative period at the preoperative stage, so that, with a high probability, it would be possible to consider alternative treatment tactics or optimize risks.

Radionuclide research methods are characterized by high reproducibility and low operator dependence [8]. Recently, stress-induced mechanical dyssynchrony of the heart (MD) has become a promising object of research, which can be assessed using such radionuclide modalities as myocardial perfusion scintigraphy [9] and radionuclide tomoventriculography (RTVG) [8]. The first of these methods may give incorrect results in patients with extensive perfusion defects, which is observed in patients with ICMP [10]. Unlike myocardial perfusion scintigraphy, RTWG visualizes the blood pool and is not affected by perfusion defects in the calculation of MD [8]. Of the studied indicators, the most poorly studied, but very promising, is Entropy, which reflects the degree of heterogeneity of the phase histogram [11]. This method is less affected by measurement noise [11] and has demonstrated a predictive role [8,11,12]. However, its role in the aspect of predicting the complicated course of the early postoperative period has not been studied before.

There are known methods for predicting complications in the postoperative period, based on the assessment of various indicators obtained during the operation and at the postoperative stage [13-17]. These methods do not allow predicting the complicated course of the early postoperative period before the operation, thus eliminating the possibility of adjusting the tactics of managing the patient and, in the case of a high risk of postoperative complications, choosing an alternative method of treatment.

There is a known method for predicting complications in patients with chronic heart failure after cardiac surgery under cardiopulmonary bypass [18], based on determining the concentration of melatonin sulfate in the nocturnal urine fraction at the preoperative stage by enzyme immunoassay. The disadvantage of this method is that the peak concentration of melatonin can shift depending on many factors (chronotype, diet, etc.) [19]. In addition, this method showed specificity values according to ROC analysis equal to 86.7% (for a melatonin sulfate concentration of 17.4 ng/ml), which is significantly inferior to the proposed method.

There is a known method for predicting the risk of complications in the early hospital period in patients after coronary artery bypass grafting under cardiopulmonary bypass [20], which consists in determining a number of markers of kidney damage (cystatin C (X, mg/l), lipocalin associated with neutrophil gelatinase - NGAL ( X, ng/ml), microalbumin (X, mg/day), interleukin-18 - IL-18 (X, pg/ml) and type 1 kidney damage molecules - KIM-1 (X, ng/ml)), after which calculate the integral indicator of kidney damage according to the corresponding formula. The disadvantages of this method is a complex logistic model that includes 5 indicators, which significantly increases the likelihood of error.

There is a known method for predicting an unfavorable outcome in patients with coronary heart disease who underwent coronary artery bypass grafting [21], which consists in determining the growth of a clot by thrombodynamics and calculating the prognostic coefficient according to the original formula. The disadvantage of this method is the identification of complications associated solely with a violation of blood coagulation, and ignoring the complications associated with a violation of the inotropic function of the heart due to metabolic disorders and the growth of intraventricular dyssynchrony.

There is a known method for predicting the risk of recurrent remodeling of the left ventricular myocardium within 12 months after surgical treatment of ischemic cardiomyopathy [22], based on the method for determining the contractile reserve of the left ventricle in patients with ICMP by conducting radionuclide tomoventriculography (RTWG) of the heart with 99mTc-pyrophosphate in the state at rest and against the background of dobutamine infusion at doses of 5, 10, 15 µg/kg/min [23]. This method is characterized by the highest reproducibility and low operator dependence in comparison with other imaging techniques in relation to determining the function of the left ventricle of the heart [24,25]. Carrying out this study on a gamma camera with ultrafast CZT detectors can significantly reduce the dose of the administered radiopharmaceutical, thus reducing radiation exposure and significantly reducing the study time. Due to these factors, it became possible to conduct this study in patients with high classes of heart failure against the background of exercise stress tests. The disadvantage of this method is the lack of data on its capabilities in relation to predicting an increased risk of complicated course of the early postoperative period in patients with ischemic cardiomyopathy at the preoperative stage.

This method is the closest to the claimed technical essence and the achieved result and is selected as a prototype.

The aim of the invention is to improve the quality of selection of patients for surgical treatment of ICMP by identifying those who have an increased risk of developing cardiovascular complications in the early postoperative period, and, in case of a high risk, choosing an alternative method of treatment.

This goal is achieved by conducting radionuclide tomoventriculography (RTWG) of the heart with 99mTc-pyrophosphate at rest and against the background of dobutamine infusion at doses of 5,10,15 μg/kg/min for 5 minutes each, the results of which determine the indicators of stress-induced changes in Entropy phase histogram (∆Entropy, %), as well as a routine echocardiographic study (EchoCG) with the calculation of the end-systolic volume of the left ventricle of the heart (ESV) and the state of the mitral valve to determine indications for surgical intervention on it. The prognostic probability of the development of complications in the early postoperative period after surgical treatment of ICMP is calculated by the formula:

where P is the predictive probability;

e is the base of the natural logarithm (mathematical constant; e=2.718);

-7.64 - logistic regression constant;

2.82; 0.23; 0.03 - weight coefficients of the corresponding indicators;

X - the presence of surgery on the mitral valve;

Y - LV Entropy, determined by the formula: LV Entropy at the peak of the stress test - LV Entropy at rest;

Z - end-systolic volume of the left ventricle of the heart according to echocardiography;

and with a P value of more than 0.5, a high probability of developing complications in the early postoperative period after surgical treatment of ICMP is predicted.

The essential features of the invention exhibit new properties in the claimed combination, which leads to the achievement of a new positive effect that does not explicitly follow from the prior art in this field and is not obvious to a specialist.

An identical set of features in the known solutions according to the patent and scientific and methodological literature has not been found.

The proposed method can be used in practical healthcare as an additional criterion for selecting patients to improve the quality of cardiac surgical treatment of ICMP.

Based on the foregoing, the proposed invention should be considered as corresponding to the conditions of patentability "Novelty", "Inventive step", "Industrial applicability".

The invention will be clear from the following description and the proposed figures.

On FIG. Figure 1 shows the phase histogram with the Entropy index, obtained during the study in the state of functional rest of the patient (A) and against the background of the stress test (B).

On FIG. Figure 2 shows ROC curves obtained from the analysis of LV CVD according to echocardiographic data. ΔEntropy LV mitral valve intervention and identified predictive model in determining the prognosis of the complicated course of the early postoperative period.

The method is carried out as follows. The patient undergoes a routine echocardiographic study, during which the CSR and the degree of mitral valve regurgitation are calculated [25]. Then the patient undergoes exercise RTWG: 24 hours before the study, patients are advised to avoid the use of caffeinated drinks, calcium channel blockers and beta-blockers. 30 minutes before the study, an intravenous catheter is inserted into the cubital vein of the subject. The label of erythrocytes in vivo is produced according to the standard protocol with the introduction of 555-740 mBq of Tc ^99m - pyrophosphate (preparation "Pirfotech" company "Diamed", Russia). The patient is positioned on the diagnostic table of a single-photon emission computed tomography scanner lying on his back with his hands behind his head. The detectors are centered on the region of the heart. The center of the energy window is set to the photopeak 99mTc - 140 keV; the width of the energy window is symmetrical (20%). An ECG and blood pressure are recorded at rest. Then RTWG is recorded at rest. After that, a series of consecutive infusions of dobutamine at doses of 5,10,15 µg/kg/min for 5 minutes each with parallel recording of RTWG is performed through the installed catheter using an infusomat. All recordings are made in ECG-synchronized mode. During the introduction of each dose of dobutamine, ECG and blood pressure are monitored. Processing of the received data is carried out in automatic and semi-automatic mode. The LV ΔEntropy indicator at the peak of the load and their difference compared to the rest indicators are calculated according to the formula: [the value of the indicator at the peak of the stress test - the value of the indicator at rest].

To obtain a formula that allows predicting the likelihood of recurrent cardiac remodeling, 74 patients with an established diagnosis of ICMP referred for surgical treatment were included in the study. Before interventional treatment, all patients underwent a complete clinical, laboratory and instrumental examination, and all patients underwent RT in the presence of dobutamine administration to assess the contractility of both ventricles of the heart.

Scintigraphic studies were performed using a Discovery NM/CT 570c single photon emission computed tomograph (GE Healthcare, USA) equipped with a gamma camera with CZT detectors.

In the early postoperative period, patients were divided into 2 subgroups depending on the presence of complications in the early postoperative period (death from cardiac causes, the need for intra-aortic balloon counterpulsation, the need for inotropic support in the intensive care unit for more than 5 days): group 1 (n=23: death - 3, IABP - 9, the need for inotropic support in the RAR > 5 days - 11) - with the presence of complications; group 2 (n=51) - no complications in the early postoperative period.

Statistical processing of the results was carried out using the software package STATISTICA v10 and MedCalc 12.1.14.0. Shapiro-Wilk test was used to assess the distribution of quantitative traits. ROC-analysis (Receiver Operating Characteristic Analysis) was used to determine the diagnostic efficiency of the studied methods. The informativeness of the diagnostic test was determined by assessing the area under the curve - Area Under Curve (AUC), as well as comparing sensitivity and specificity. The nonparametric DeLong test was used to compare the ROC curves. To build a model for predicting the development of repeated remodeling, regression analysis was used in the form of binary logistic regression: odds ratios (OR) and confidence interval (CI) were calculated. Differences were considered statistically significant at p<0.05.

According to multivariate logistic regression analysis, mitral valve intervention (OR = 9.8; CI 1.92; 7.9; p = 0.005), LV Entropy (OR = 1.35 ; CI 1.07; 1.7; p=0.009), LV ESV (OR = 1.04; CI 1.0; 1.08; p = 0.008).

Using the regression coefficients of the identified scintigraphic parameters, an equation was derived to calculate the prognostic probability of a complicated course of the early postoperative period after surgical treatment of patients with ICMP:

where P is the predictive probability;

e is the base of the natural logarithm (mathematical constant; e=2.718);

-7.64 - logistic regression constant;

2.82; 0.23; 0.03 - weight coefficients of the corresponding indicators;

X - the presence of surgery on the mitral valve;

Y - LV Entropy, determined by the formula: LV Entropy at the peak of the stress test - LV Entropy at rest;

Z - end-systolic volume of the left ventricle of the heart according to echocardiography,

and with a P value of more than 0.5, a high probability of developing complications in the early postoperative period after surgical treatment of ICMP is predicted.

According to the results of the ROC analysis, the presence of intervention on the mitral valve had a sensitivity value of 40% and a specificity of 86% (AUC=0.633), LV CSR had a sensitivity value of 60% and a specificity of 70% for a threshold value >148ml (AUC=0.690), LV Entropy showed a sensitivity value of 86% and a specificity of 54% for a value >0 (AUC=0.740). The logistic model, taking into account all of the above indicators, had a sensitivity of 74%, a specificity of 95% and AUC=894, which was significantly higher than the AUC values obtained when analyzing each of the above (p<0.05) indicators separately.

Clinical example 1 (complicated course of the early postoperative period).

The patient is 57 years old. Diagnosis - ischemic cardiomyopathy, chronic heart failure III functional class (NYHA). According to echocardiography, LV EF = 33%, LV ESV = 167 ml. According to angiography - stenosis of the AAD 75%, RCA - 75%, OA - 60%. According to the results of RTWG with dobutamine, LV ΔEntropy was +10%. Using the obtained data, the probability value was calculated:

P=0.87

The obtained value of P=0.87 allows us to assume at the preoperative stage that this patient should be expected to have a severe course of the early postoperative period.

The patient underwent coronary artery bypass grafting, left ventricular plasty and MV plasty. In the early postoperative period, due to the lack of adequate recovery of contractile function and the need to use intra-aortic balloon counterpulsation, the patient spent 12 days in the intensive care unit against the background of inotropic support.

Clinical example 2 (no complications in the early postoperative period).

The patient is 59 years old. Diagnosis - ischemic cardiomyopathy, chronic heart failure III functional class (NYHA). According to echocardiography, LV EF = 29%, LV ESV = 145 ml. According to angiography - 75% stenosis of the ACA, 70% of the RCA, 90% of the RCA. According to the results of RTWG with dobutamine, LV ΔEntropy was -5%. Using the obtained data, the probability value was calculated:

P=0.01

The obtained value of P=0.01 allows us to assume at the preoperative stage that this patient has a low chance of developing complications in the early postoperative period.

The patient underwent coronary artery bypass grafting and left ventricular plasty. After the operation, 24 hours later, the patient was transferred from the intensive care unit to the ward, the course of the postoperative period was normal.

The method proposed as an invention was tested on 74 patients and allows to increase the accuracy of identifying patients with a high risk of a complicated course of the early postoperative period at the preoperative stage and to correct the tactics of managing patients with ICMP.

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Claims (6)

A method for predicting the development of a complicated course of the early postoperative period in patients with ischemic cardiomyopathy at the preoperative stage, which consists in performing echocardiography (EchoCG) and determining the final systolic volume of the left ventricle (LV ESV), performing radionuclide equilibrium ventriculography with 99mTc-pyrophosphate at rest and against the background of consecutive intravenous infusions of dobutamine at doses of 5, 10, 15 mcg/kg/min for 5 minutes for each dose and determine the Entropy of the left ventricle at rest and Entropy of the left ventricle at the peak of the stress test, after which the prognostic probability of developing a complicated course of early postoperative period in patients with ischemic cardiomyopathy (P) according to the formula: Р=1/(1+e ^{(-(-7.64+2.82*Х-0.23×Y+0.03*Z))) )} , where X is equal to 1 if the patient has surgery on the mitral valve, equals 0 if the patient does not have surgery on the mitral valve; Y - LV ΔEntropy, calculated by the formula LV Entropy = (LV Entropy at the peak of the stress test - LV Entropy at rest); Z - LV CSR; and when the value of P is greater than 0.5, the development of complications in the early postoperative period after surgical treatment of ischemic cardiomyopathy is predicted.