RU2780940C1 - Method for predicting the risk of sternal infection in cardiac surgery patients - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to surgery and cardiovascular surgery. Risk factors are determined: body mass index (BMI), the presence of lung diseases, emergency surgery, the use of cardiotropic therapy, the duration of the operation and the use of an artificial blood flow apparatus. The identified risk factors are evaluated in points. The sum of the received points is calculated. When receiving a score of 14 and above, a high risk is predicted, with a score of 11 to 13 - a moderate risk, with a score of less than 11 - a low risk of developing a sternal infection in the postoperative period.

EFFECT: method allows to objectively and quickly determine the risk of developing sternal infection in patients with cardiosurgical profile by assessing the complex of the most significant risk factors.

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Description

The invention relates to medicine, namely to surgery and can be used in surgery and cardiovascular surgery.

The most common complication of the postoperative period in cardiac surgery patients is the development of sternal infection, the incidence of which ranges from 0.4 to 5%. The development of this complication of the postoperative period is due to the known difficulties in achieving the elimination of infection of the sternum tissues after median sternotomy:

[Suvorov V.V., Khubulava G.G., Naumov A.B., Trashkov A.P., Shikhverdiev N.N., Marchenko S.P., Vasiliev A.G., Averkin I.I. The current state of the problem of the development of sternal infection in cardiac surgery (literature review) // Infections in Surgery. - 2012. - No. 3, Vol. 10. - P.17-21.

Arutyunyan L.A., Efanov Yu.M., Kremneva L.V., Safiullina Z.M., Shalaev S.V. Complications after coronary artery bypass grafting and modern methods of their prevention // Medical Science and Education of the Urals. - 2009. - T. 10, No. 3 (59). - S. 127-134.

Protasevich A.I., Tatur A.A. The effectiveness of vacuum therapy in the treatment of postoperative sternomediastinitis: a systematic review and meta-analysis // News of Surgery. - 2016. - No. 3, T. 24. - S. 275-284].

The issues of predicting the development of sternal infection and its prevention, the search for objective criteria for predicting this complication are very relevant and occupy a significant place in modern literature.

[Sotnikov A.V., Melnikov M.V., Elmadzhi R.V., Gorbunov G.N. On the issue of prevention of mediastinitis in cardiosurgical patients. Bulletin of the North-Western State Medical University. I.I. Mechnikov. - 2015. - No. 4, V.7. - S. 38-42.

Khubulava G.G., Shikhverdiev N.N., Naumov A.B., Suvorov V.V., Marchenko S.P., Averkin I.I. Pathophysiological mechanisms and risk factors for the development of sternal infection in cardiac surgery // Bulletin of the Russian Military Medical Academy. - 2013. - No. 1 (41). - S. 174-179.

RF patent No. 2707262, А61В17/00, BIPM No. 33, November 25, 2019].

There is a way to prevent postoperative anterior mediastinitis after performing a full longitudinal sternotomy in open heart surgery. The method consists in the multi-stage administration of a cefazolin solution during surgical intervention: in the preoperative period, the addition of an antibiotic to the heart-lung machine, local injection into the retrosternal space and onto soft tissues. The method is not predictive and involves the administration of an antibiotic to all patients, regardless of the risk of sternal infection [RF Patent No. 2707262, A61V17/00, BIPM No. 33, 11/25/2019].

The closest in terms of the essential features of the claimed invention is a method for determining the degree of healing of the sternum during its fixation after cardiac surgery with complete median sternotomy. The method consists in performing computed tomography in the postoperative period. Then, calculations are carried out on axial sections in the bone mode at 4 defining points corresponding to suturing, connecting the edges of the sternum and bearing the main load: the upper edge of the sternum handle (M ₁ ), the lower edge of the sternum handle (M ₂ ), the upper part of the sternum body at the level of the 2nd intercostal space (C ₁ ), the lower body of the sternum at the level of the 4th intercostal space (C ₂ ). Then, the assessment is carried out according to the criteria: 0 - diastasis between the fragments of the sternum more than 3 mm, 1 - diastasis between the fragments of the sternum 0-3 mm without signs of fusion, 2 - there is no diastasis between the fragments of the sternum, there are x-ray signs of the emerging callus - cloudy, filiform shadows, 3 - complete consolidation. According to the total score, the degree of healing of the sternum is judged from the minimum - with a total of 0 points, which corresponds to diastasis of the sternum over 3 mm throughout without the possibility of self-union, to the maximum - with a total of 12 points, which corresponds to complete consolidation of the sternum throughout its entire length. The method provides the most accurate determination of the degree of healing of the sternum in such patients, but does not allow predicting the development of sternal infection [RF Patent No. 2647796, A61V5/00, BIPM No. 8, 03/19/2018].

The objective of the proposed method is to predict the development of sternal infection in the preoperative period in patients with cardiac surgery profile.

The problem is solved by determining the following risk factors for the development of sternal infection in patients with cardiac surgery profile: body mass index, lung diseases, diabetes mellitus, urgency of the operation, the use of cardiotropic therapy, the duration of the operation, the duration of the use of the artificial blood flow apparatus, prolonged mechanical ventilation, which certain points are assigned, the risk of developing a sternal infection is predicted by the sum of the points.

The method is carried out as follows: the following factors are evaluated - the body mass index increases the risk of developing a sternal infection as follows, up to 23 units 0 points, from 23 to 25 units 1 point, 25 units 2 points and over 25 units assigned 3 points. Lung diseases identified in the anamnesis were a significant adverse factor, which was estimated at 2 points. A proven risk factor for the development of inflammatory complications in the postoperative period is the urgency of the operation, this feature was assigned 2 points. The use of cardiotropic therapy confirms the presence of an ischemic syndrome, which adversely affects the healing of the sternotomy wound in the future, and is estimated at 2 points. The duration of the operation often worsens the course of the postoperative period, the duration of the operation from 180 to 200 minutes was estimated at 1 point, from 201 to 249 minutes - 2 points and more than 250 minutes was estimated at 3 points. The duration of use of the artificial blood flow apparatus was a risk factor for the development of sternal infection, with a duration of 100 to 119 minutes, 1 point was assigned, more than 120 minutes - 2 points. Then the scores were summed up, with a score of 14, a high risk of developing a sternal infection in the postoperative period was predicted, with a score of 11 to 13, it was assessed as a moderate risk, and with a score of less than 11, as a low risk of developing an unfavorable course of the postoperative period.

2266 case histories of patients operated on by performing a median sternotomy in the cardiosurgical department of the Krasnoyarsk Regional Clinical Hospital for the period 2017-2020 were analyzed. The study included 68 (3%) patients. The criterion for inclusion of patients in the study was the development in the postoperative period of an isolated superficial (group I) or an isolated deep sternal infection (group II).

In order to determine diagnostically significant signs, 20 putative risk factors for postoperative bleeding were subjected to statistical analysis, including 2 non-modifiable factors - age and gender. The following were considered as anamnestic risk factors: diabetes mellitus, chronic obstructive pulmonary disease, obesity, generalized atherosclerosis, osteoporosis, infective endocarditis, smoking for more than 10 years. The following factors directly related to surgery were taken into account: the urgency of the operation, coronary artery bypass grafting, the use of cardiotropic support, repeated surgical interventions, as well as the duration of the operation, mechanical ventilation or the use of an artificial blood flow apparatus.

Among the laboratory risk factors, the results of a detailed general blood test (erythrocyte and leukocyte count, hemoglobin level, leukocyte count, platelet count, ESR, etc.), biochemical blood test (glucose, albumin, electrolytes, creatinine, bilirubin levels) were taken into account.

The group of factors directly related to the risk of developing inflammatory complications in patients undergoing sternotomy included such as performing asymmetric sternotomy, deformities of the sternocostal complex.

However, when performing logistic regression using the Statistica 6.1 software package, the following were identified as the most significant risk factors for developing sternal infection: body mass index, lung diseases, diabetes mellitus, urgency of surgery, use of cardiotropic therapy, duration of surgery, duration of use of an artificial blood flow device, prolonged IVL. The significance of the above risk factors is presented in Table No. 1.

Table 1. Significance of putative risk factors for the development of sternal infection in the examined patients.

risk factor OR (RR) Confidence interval (CI) 95% Significance level (Yates-adjusted Chi-square test) Criterion
V Cramer Strength of association between risk factor and outcome BMI above 25 I group 3.281 1.848- 5.823 p<0.001 0.611 strong II group 4,846 2.13-11.024 p<0.001 0.641 strong Diabetes I group 1.2 0.801-1.798 p=0.483 0.113 weak II group 1.333 0.752-2.364 p=0.451 0.140 weak lung diseases I group 1.717 1.226- 2.403 p=0.017 0.314 average II group 1.567 0.887-2.768 p=0.336 0.178 weak emergency operation I group 1.657 1.194- 2.3 p=0.045 0.273 average II group 1.8 1.068-3.033 p=0.172 0.234 average Use of cardiotropic support I group 1.193 0.8-1.778 p=0.524 0.103 weak II group 3.056 1.224- 7.625 p=0.008 0.395 average Use of extended ventilation I group 2.388 0.778- 7.327 p=0.209 0.177 weak II group 1.663 0.699- 3.954 p=0.330 0.173 weak The average duration of the operation is more than 250 minutes I group 2.666 1.602-4.437 p<0.001 0.531 relatively strong II group 10.4 2.714-39.858 p<0.001 0.723 strong The average duration of use of the artificial blood flow apparatus is more than 120 minutes. I group 1.016 0.687-1.502 p=0.874 0.009 insignificant II group 3.937 1.353-11.460 p<0.003 0.44 relatively strong

Subsequently, in the course of logistic regression, the identified significant risk factors were assigned scores that in total affect the prognosis of the risk of complications in the postoperative period. The number of points assigned to signs depended on the strength of the relationship between the risk factor and the outcome of the disease, the data are presented in Table 2.

2 - Factor assessment of the risk of sternal infection in patients with cardiac surgery profile (risk factors - in the appropriate units of measurement, assessment - in points)

Factors
risk Points 0 +1 +2 +3 BMI above 25 up to 23 23-25 25 over 25 lung disease - - + - emergency operation - - + - Use of cardiotropic support - - + - Average duration of the operation, min. - 180-200 201-249 over 250 Average duration of use of the artificial blood flow apparatus, min. - 100-119 over 120 -

Note: "+" - the presence of a sign, "-" - is not taken into account.

Calculation of the risk of developing sternal infection was carried out immediately after surgery, which later allowed to adjust the infusion therapy.

The scores were summarized, with a score of 14, a high risk of developing sternal infection in the postoperative period was predicted, with a score of 11 to 13, it was assessed as a moderate risk, and with a score of less than 11, as a low risk of developing an unfavorable course of the postoperative period.

The following are clinical examples of case histories of patients with varying degrees of prognosis for the development of sternal infection in the postoperative period.

Clinical example No. 1. Patient D., aged 51, was admitted on an emergency basis to the cardiosurgical department of the Krasnoyarsk Regional Clinical Hospital with a diagnosis of mitral heart disease.

The body mass index was 31.2 at the time of admission. She has a history of chronic obstructive bronchitis, in the stage of compensation. The duration of the operation was 260 minutes. Duration of use of the artificial blood flow apparatus 180 min. When suturing the sternotomy wound, osteosynthesis with a metal wire was used. Cardiotropic support in the postoperative period was 3 days. Thus, the total score was 14, which corresponds to a high risk of developing sternal infection.

Purulent mediastinitis and sepsis developed in the postoperative period. An autopsy was performed, drainage of mediastinitis. The patient received intensive care in the intensive care unit for 12 days, positive dynamics was noted during the course of the disease, and was discharged on the 31st day.

Clinical example No. 2. Patient K., aged 46, was admitted on an emergency basis to the cardiosurgical department of the Krasnoyarsk Regional Clinical Hospital with a diagnosis of Concomitant heart disease.

The body mass index was 28.4 at the time of admission. He denies chronic lung diseases and diabetes mellitus in anamnesis. The duration of the operation was 215 minutes. Duration of use of the artificial blood flow apparatus 140 min. When suturing the sternotomy wound, osteosynthesis with a metal wire was used. Cardiotropic support in the postoperative period was 6 days. Thus, the total score was 11, which corresponds to the average risk of developing sternal infection.

In the postoperative period, the sternum play was 1 mm; on the 5th day, ligature fistulas were diagnosed. In the course of antibiotic therapy and effective local treatment, the wound healed by secondary intention, the patient was discharged on the 17th day.

Clinical example No. 3. Patient S., 64 years old, was enrolled in a planned manner in the cardiosurgical department of the Krasnoyarsk Regional Clinical Hospital with a diagnosis of Concomitant heart disease.

The body mass index was 21.8 at the time of admission. He denies chronic lung diseases and diabetes mellitus in anamnesis. The duration of the operation was 205 minutes. The duration of use of the artificial blood flow apparatus is 110 minutes. When suturing the sternotomy wound, osteosynthesis with a metal wire was used. Cardiotropic support in the postoperative period was not required. Thus, the total score was 4, which corresponds to a low risk of developing sternal infection.

The postoperative period was uneventful, the postoperative wound healed by primary intention, the patient was discharged on the 12th day.

Approbation of the developed method for predicting the risk of developing sternal infection in patients with a cardiac surgical profile according to risk factors showed high diagnostic significance: accuracy was 95.4%, sensitivity - 91.7%, specificity - 98.1%, predictive value of a positive result - 92, 3%, negative predictive value - 95.6%.

The method for identifying the risk of developing a sternal infection in patients with a cardiac surgical profile using risk factors has the following advantages:

1) simplicity and speed of implementation;

2) the possibility of a clear prediction of the course of the pathological process in the first 24 hours after surgery, which makes it possible to effectively correct postoperative treatment.

Claims (1)

A method for detecting the risk of developing a sternal infection in patients with a cardiac surgical profile, including the determination of risk factors, characterized in that the following are determined as risk factors: body mass index (BMI), the presence of lung diseases, emergency surgery, the use of cardiotropic therapy, the duration of the operation and the use of an artificial limb blood flow, then evaluate the identified risk factors in points: BMI up to 23 - 0 points, from 23 to 25 - 1 point, 25 - 2 points and over 25 - 3 points; when detecting lung diseases, emergency surgery, the use of cardiotropic therapy, 2 points are assigned; the duration of the operation from 180 to 200 minutes - 1 point, from 201 to 249 minutes - 2 points and more than 250 minutes - 3 points; the duration of use of the artificial blood flow device from 100 to 119 minutes - 1 point, more than 120 minutes - 2 points, calculate the amount of points received and when receiving a score of 14 or more, a high risk is predicted, with a score of 11 to 13 - a moderate risk, with a total scores less than 11 - low risk of sternal infection in the postoperative period.