Development of Innovative Technologies for the Treatment of Pulmonary and Heart Failure to Prolong Human's Life
Phase: NA
Conditions: Cardiogenic Shock, Ventricular Arrythmia, Cardiac Arrest With Successful Resuscitation, Sepsis, Multiple Organ Failure, Pulmonary Failure, Decompensated Heart Failure, Acute Heart Failure
Sponsor: National Research Center for Cardiac Surgery, Kazakhstan

Title: Development of 
innovative technologies for the 
treatment of pulmonary and 
heart failure to prolong 
human's life 
 
 
NCT number: Will be 
provided  
 
Date: 01.01.2021 
 

 
1. Annotation 
There are used multiple techniques to reduce the syndrome of systemic inflammatory 
response, immunocorrection, and others in order to improve the results of implantation of 
mechanical devices, patients on the extracorporeal life-sustaining system and septic patients 
before surgery. Today, there are many ways to prevent the development of a systemic 
inflammatory response by removing leukocytes from the bloodstream by integrating a filter 
with a special screen in the perfusion circuit to remove leukocytes and prevent the latter from 
entering the systemic circulation. 
The most effective approach is the method of extracorporeal hemadsorption, intended 
for additional therapy of patients with an increased level of cytokines in conditions of the 
systemic inflammatory response syndrome, in which a patient with acute pulmonary distress 
syndrome and cardiogenic septic shock against the background of an extracorporeal 
hemofiltration, an extracorporeal cytokine adsorber system was installed, intended to 
eliminate a wide range of inflammatory mediators, as well as multiple proteins and 
metabolites. 
The purpose of the program. 
Formulation of new treatments for heart and pulmonary failure through using organ-
replacing technologies. 
Formulation of a clinical protocol and implementation of treatment methods into 
clinical practice heart and pulmonary failure using organ-replacing technologies. 
Study design. 
Study type: interventional (clinical study) 
Set of participants: 100 participants 
Distribution: randomized 
Interventional model: parallel  
Masking: no 
 
Primary Goal: Treatment 
New methods were created for rehabilitating the function of affected organs after 
implantation of the LVAD, a total artificial heart, an extracorporeal life-sustaining system 
will be of great importance, both for Kazakhstan and for states with similar problems of 
donor organ deficiency, will also improve the effectiveness of surgical treatment and reduce 

the level of complications and mortality of patients on the extracorporeal life-sustaining 
system and septic patients. 
Furthermore, the results will lead to modernization and an increase in the share of 
innovative organ-replacing technologies in the health care system.  
2. Explanatory note 
 1. General information 
1.1. Name of the topic of the scientific, scientific and technical program "Development 
of innovative technologies for the treatment of pulmonary and heart failure to prolong 
human's life". 
1.3. Location of the program. ~The Republic of Kazakhstan, Nur-Sultan. 
1.4. Estimated start and end date of the program, its duration in months. 2021 - 2023 
years, 36 months. 
1.5. Organization applying for the program. Non-profit JSC "National Research Center 
for Cardiac Surgery". 
1.6. Executors of the program. Non-profit JSC «National Research Center for Cardiac 
Surgery». 
1.7. The requested amount of targeted program financing for the entire duration of the 
program is 240 265 thousand tenge, 2021 - 84 107 thousand tenge, 2022 - 84 817 thousand 
tenge, 2023 - 71 340 thousand tenge. 
1.8. Key words characterizing the sector and the direction of the program for the 
selection of independent experts. Anesthesiology. Cardiothoracic surgery. Nephrology. 
Perfusion. Efferentology. 
 
 2. The general concept of the program. 
2.1. Introductory part. 
Non-profit JSC «National Research Center for Cardiac Surgery» (hereinafter – Non-
profit JSC "NRCCS") is a research center that implements a program for the treatment of 
patients with chronic heart failure (CHF) and pulmonary failure (PF) in the terminal stage, 
including orthotopic transplantation of the heart and lungs, mechanical support of blood 
circulation. 
Scientific supervisor of the program - Yuriy Vladimirovich Pya - Director for Surgery 
and Science of the Non-profit JSC «NRCCS», Associate Professor, Doctor of Medical 
Sciences, cardiac surgeon of the highest category. 

Scientific co-director of the program - Timur Dostaevich Lesbekov - Non-profit JSC 
«National Research Center for Cardiac Surgery», candidate of medical sciences, cardiac 
surgeon of the highest category. 
The implementation of this program will improve organ recovery, reduce postoperative 
complications, reduce postoperative mortality and improve the quality of life of patients with 
pulmonary and heart failure. 
2.2. The purpose of the program. 
Development of new treatments heart and pulmonary failure using organ-replacing 
technologies. 
Development of a clinical protocol and implementation of treatment methods into 
clinical practice heart and pulmonary failure using organ-replacing technologies. 
2.3. Objectives of the program. 
 Task 1. Assessment the results of the use of extracorporeal life support systems in 
the treatment of pulmonary and / or heart failure.  
Subtask 1.1. Assessment of the restoration of organ function during extracorporeal life 
support systems using extracorporeal hemocorrection. 
Subtask 1.2. Assessment of the normalization of the body's immune response and 
restoration of organ function during extracorporeal life support systems using an 
extracorporeal cytokine adsorber. 
Task 2. Studying the restoration of organ function during implantation of the left 
ventricular assist device as an organ-replacing aid in heart failure. 
Subtask 2.1. Assessment of the restoration of organ function during implantation of the 
left ventricular assist device with the use of extracorporeal hemocorrection. 
Subtask 2.2. Assessment of the normalization of the body's immune response and 
restoration of organ function upon implantation of the left ventricular assist device using an 
extracorporeal cytokine adsorber. 
Task 3. Studying the restoration of organ function during the implantation of the 
total artificial heart as an organ-replacing aid in case of heart failure. 
Task 3.1. Assessment of normalization of organ function restoration during 
implantation of the total artificial heart with the use of extracorporeal hemocorrection. 
Task 4. Studying the restoration of organ function during operations in conditions 
of the long-term cardiopulmonary bypass. 

Task 4.1. Assessment of the restoration of organ function during operations with long-
term cardiopulmonary bypass, hypothermia and circulatory arrest, with the use of 
extracorporeal hemocorrection. 
Task 4.2. Assessment of the restoration of organ function during operations with long-
term cardiopulmonary bypass, hypothermia and circulatory arrest using an extracorporeal 
cytokine adsorber. 
Task 5. Improvement of the method of implantation of organ-replacing 
technologies to reduce complications in the treatment of heart and pulmonary failure. 
3. Scientific innovativeness and significance of the program. 
Organ replacement technologies are increasingly being used in the treatment of end-
stage pulmonary and heart failure to prolong human life. Severe refractory cardiogenic shock, 
refractory ventricular arrhythmia, active cardiopulmonary resuscitation in cardiac arrest and 
acute or decompensated right heart failure, sepsis, pulmonary and multiple organ failure. 
Careful patient selection and consideration of possible complications are key factors in 
optimizing the treatment of patients in this category. Well-defined pathways for medical care 
to centers capable of delivering heart and lung support replacement therapy (e.g., durable 
ventricular assist device or heart transplant) is essential to provide high-level patient care, 
stabilized with extracorporeal life support, and the ability to wean from the device. 
Ultimately, the concentration of the most complex care in large centers of our country with 
developed cardiac surgery and anesthetic capabilities can be a way to significantly improve 
the care of this group of patients. 
Despite advances in mechanical ventilation, severe acute pulmonary distress syndrome 
(APDS) is associated with high morbidity and mortality rates ranging from 26% to 58%. 
Extracorporeal life sustaining system is a procedure for long-term cardiopulmonary bypass 
and oxygen saturation of the blood outside the body, used in patients with acutely developed 
and potentially reversible pulmonary and / or heart failure, whose treatment does not respond 
to maximum standard therapy. The Heart-Lung Sustaining System is a complex network that 
provides oxygenation and ventilation and allows the lungs to rest and recover from 
pulmonary failure while minimizing the iatrogenic lung damage caused by the ventilator. In 
intensive care in the conditions of an extracorporeal life support system. In 2011, the 
National Research Center for Cardiac Surgery Non-profit JSC launched a program to provide 
extracorporeal life support system in Kazakhstan, and in 2016 Non-profit JSC «NRCCS» has 
entered to the global ELSO register (Extracorporeal Life Support Organization). 

The constant increase in the number of patients with CHF is associated with both an 
increase in the life expectancy of patients and a decrease in mortality among patients with a 
complicated course of acute myocardial infarction, heart defects, etc. The most common 
causes leading to the development of CHF are arterial hypertension, coronary heart disease 
and myocardial infarction. The gold standard for treatment of patients with end-stage heart 
failure, tolerant to drug therapy is heart transplantation. 
Deficiency of donor organs remains the most important factor holding back the 
development of lung and heart transplantation all over the world and in our country. Left 
ventricular assist device (LVAD) implantation is a bridge to heart transplantation, which 
improves the quality and duration of life by improving blood circulation in most patients with 
chronic heart failure [1]. In recent studies, it was shown that the 1-year survival rate of 
patients after implantation of mechanical blood circulation support devices as a "bridge to 
transplantation" (BTT - bridge to transplantation) was 85%, and the 2-year survival rate in 
patients with ventricular assist device as " final treatment "(" DT - destination therapy ") - 
76% [2]. It was also noted that patients with LVAD support improve functional status and 
quality of life [2]. 
A Total Artificial Heart is a form of mechanical circulatory support in which the 
patient's ventricles and valves are removed and replaced with an artificial heart. Currently, a 
fully artificial heart is implanted in the terminal stage of biventricular heart failure as a 
"bridge" to heart transplantation. However, given the increasing global burden of 
cardiovascular disease and congenital heart disease with heart failure, the number of end-
stage heart failure patients awaiting heart transplants now far outnumbers the available hearts. 
As a result, the use of mechanical circulatory support, including a fully artificial heart, is 
growing exponentially. 
Sepsis, septic shock, and systemic inflammatory response syndrome are life-threatening 
conditions resulting from a systemic response. Dysregulation can lead to multiple organ 
dysfunctions [30-36]. 
While sepsis and septic shock are infectious in origin, systemic inflammatory response 
syndrome (SIRS) can also have noninfectious triggers such as open heart bypass surgery, ex 
vivo heart / lung perfusion, extracorporeal life support, and mechanical circulatory support. It 
should be noted that mortality in SIRS, septic shock and sepsis reaches 7, 16, and 40%, 
accordingly [37-45]. According to Sepsis-3 2016, the new definition has two categories: 
sepsis and septic shock [46-49]. Previous definitions of sepsis, published in 1992, have 

highlighted the role of systemic inflammatory response syndrome (SIRS) as a key element in 
the definition of sepsis. 
In order to improve the results of implantation of mechanical devices, patients on the 
extracorporeal life support system and septic patients before surgery, various techniques are 
used to reduce the syndrome of systemic inflammatory response, immunocorrection, and 
others. To date, there are many ways to prevent the development of a systemic inflammatory 
response by removing leukocytes from the bloodstream by including a filter with a special 
screen in the perfusion circuit to remove leukocytes and prevent the latter from entering the 
systemic circulation [9]. 
The most effective is the method of extracorporeal hemadsorption, intended for 
additional therapy of patients with an increased level of cytokines in conditions of the 
systemic inflammatory response syndrome, in which a patient with acute pulmonary distress 
syndrome and cardiogenic septic shock against the background of an extracorporeal system 
has additional life support in the circuit of the apparatus for the veno-venous hemofiltration, 
an extracorporeal cytokine adsorber system was installed, designed to eliminate a wide range 
of inflammatory mediators, as well as various proteins and metabolites [55-61]. 
There are some new data showing that the use of an extracorporeal cytokine adsorber 
for long periods of cardiopulmonary bypass surgery (> 120 minutes) may be useful for 
preventing SIRS and reducing cytokine levels in patients have overcome by elective heart 
surgery [62-68]. 
In this study, methods will be developed to restore the function of affected organs 
before and / or after mechanical support of blood circulation (implantation of a completely 
artificial heart, implantation of an artificial left ventricle, an extracorporeal life support 
system) in combination with the use of an extracorporeal cytokine adsorber, which will 
improve the results of surgical treatment of patients with terminal heart and pulmonary 
failure. 
New methods developed for restoring the function of affected organs after implantation 
of an artificial left ventricle, a completely artificial heart, an extracorporeal life support 
system will be of high importance, both for Kazakhstan and for states with similar problems 
of donor organ deficiency, will also improve the effectiveness of surgical treatment and 
reduce the level of complications and mortality of patients on the extracorporeal life support 
system and septic patients. 
The clinical study data will form the basis of practical protocols for the implantation of 
an artificial left ventricle, a fully artificial heart, an extracorporeal life support system, 

following which will improve organ recovery, reduce postoperative complications, improve 
the quality of life and reduce mortality after surgery. 
4. Research methods and ethical issues. 
All patients admitted to Non-profit JSC ―NRCCS‖ who meet the study criteria (patients 
on an extracorporeal life support system, mechanical circulatory support, surgery on the 
aortic arch) will be included in the study after obtaining a signed informed consent. 
Participants will be randomized into 2 groups in a 1: 1 division. 
Intervention team # 1 using an extracorporeal hemoperfusion device Jafron (Zhuhai 
Jafron Biomedical, China) (50 patients) in subgroups: A (n = 10) - patients on extracorporeal 
life support systems with heart failure; B (n = 10) - patients on extracorporeal life support 
systems with pulmonary failure; C (n = 5) - patients with implantation of a left ventricular 
accessory device; D (n = 25) - during operations with prolonged artificial circulation, 
hypothermia and circulatory arrest. 
Intervention team # 2 using extracorporeal cytokine, CytoSorb (CytoSorbents 
Corporation, Monmouth Junction, NJ, USA) (50 patients) in subgroups: A (n = 10) - patients 
on extracorporeal life support systems in heart failure; B (n = 10) - patients on extracorporeal 
life support systems with pulmonary failure; C (n = 5) - patients with implantation of a left 
ventricular accessory device; D (n = 25) - during operations with prolonged artificial 
circulation, hypothermia and circulatory arrest. 
Retrospective analysis of patients who received a fully artificial heart. 
The duration of the intervention in each group will be 72 hours. Each Jafron / CytoSorb 
Removal Column can be used within 24 hours, so all patients in 2 groups use 3 filters during 
the study. 
Researchers will collect demographic, clinical and laboratory data from patients before, 
during and after surgery. 
The incidence of early cellular or humoral rejection, the duration of ventilation, 
intensive care and hospital stay, the use of vasopressors and inotropes in the perioperative 
period, and the incidence of perioperative complications and survivals will be documented. 
The level of cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor alpha) and 
complements will be determined before, during and after the use of the extracorporeal life 
support system for heart and pulmonary failure; surgery on the aortic arch, patients on 
mechanical circulatory support, if investigators find a corresponding difference between the 
two groups in terms of clinical variables. 
Study design. 

Study type: interventional (clinical study) 
Set of participants: 100 participants 
Distribution: randomized 
Interventional model: parallel  
Masking: no 
Primary Goal: Treatment 
 
Intervention team (1 group)  
Intervention / treatment (device) 
Extracorporeal hemoperfusion device will be 
installed in the device of the extracorporeal 
life support system for heart failure... 
 (10 patients) 
HA330 - Jafron Biomedical Co., Ltd., China 
- extracorporeal hemocorrection, which is 
based on the removal of cytokines from 
whole blood by sorption on a special 
hemoadsorbent due to the peculiarities of its 
porous structure and inner surface, which is 
indicated in conditions where cytokine levels 
are extremely elevated. 
Extracorporeal hemoperfusion device will be 
installed in the device of the extracorporeal 
life support system for pulmonary failure 
 (10 patients). 
HA330 - Jafron Biomedical Co., Ltd., China 
- extracorporeal hemocorrection, which is 
based on the removal of cytokines from 
whole blood by sorption on a special 
hemabsorbent due to the peculiarities of its 
porous structure and inner surface, which is 
indicated in conditions where cytokine levels 
are extremely elevated. 
An extracorporeal hemoperfusion device will 
be installed in patients before / during the 
implantation of a left ventricular assist device 
(5 patients). 
HA330 - Jafron Biomedical Co., Ltd., China 
- extracorporeal hemocorrection, which is 
based on the removal of cytokines from 
whole blood by sorption on a special 
hemoadsorbent due to the peculiarities of its 
porous structure and inner surface, which is 
indicated in conditions where cytokine levels 
are extremely elevated. 
An extracorporeal hemoperfusion device will HA330 - Jafron Biomedical Co., Ltd., China 

be installed in patients during operations with 
prolonged 
cardiopulmonary 
bypass, 
hypothermia and circulatory arrest. (25 
patients). 
- extracorporeal hemocorrection, which is 
based on the removal of cytokines from 
whole blood by sorption on a special 
hemoadsorbent due to the peculiarities of its 
porous structure and inner surface, which is 
indicated in conditions where cytokine levels 
are extremely elevated. 
Intervention team (2 groups) 
 
Extracorporeal hemoperfusion device will be 
installed in the device of the extracorporeal 
life support system for heart failure. 
 (10 patients) 
CytoSorb (CytoSorbents Corp., USA) - an 
extracorporeal 
cytokine 
adsorber 
is 
a 
biocompatible polymer with high adsorption 
capacity, which is indicated in conditions 
where cytokine levels are extremely elevated. 
Extracorporeal hemoperfusion device will be 
installed in the device of the extracorporeal 
life support system for pulmonary failure. 
 (10 patients) 
CytoSorb (CytoSorbents Corp., USA) - an 
extracorporeal 
cytokine 
adsorber 
is 
a 
biocompatible polymer with high adsorption 
capacity, which is indicated in conditions 
where cytokine levels are extremely elevated. 
An extracorporeal hemoperfusion device will 
be installed in patients before / during the 
implantation of a left ventricular assist device 
(5 patients) 
CytoSorb (CytoSorbents Corp., USA) - an 
extracorporeal 
cytokine 
adsorber 
is 
a 
biocompatible polymer with high adsorption 
capacity, which is indicated in conditions 
where cytokine levels are extremely elevated. 
An extracorporeal hemoperfusion device will 
be installed in patients during operations with 
prolonged 
cardiopulmonary 
bypass, 
hypothermia and circulatory arrest. (25 
patients) 
CytoSorb (CytoSorbents Corp., USA) - an 
extracorporeal 
cytokine 
adsorber 
is 
a 
biocompatible polymer with high adsorption 
capacity, which is indicated in conditions 
where cytokine levels are extremely elevated. 
 
Performance evaluation criterias 
 
Extracorporeal life support system with pulmonary and / or heart failure 
Primary results 

1 
Cytokine response [Time: 24-48 hours] 
The level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor 
alpha-factor) before the implantation, 2 hours after the start of ECMO support, 
explantation of ECMO, 24 hours after explantation of ECMO. 
2 
SOFA-Score [Time Frame: 24, 48, 72 hours] 
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, 
where the higher values explain higher disease severity) 
3 
Difference of mean arterial pressure [Time Frame: 24, 48, 72 hours] 
Comparison of mean arterial pressure at 24, 48, 72 hours between between two 
interventions (CytoSorb and Jafron) 
4 
Difference of CVP [Time Frame: 24, 48, 72 hours] 
Comparison of CVP at 24, 48, 72 hours between between two interventions 
(CytoSorb and Jafron) 
5 
Serum lactate [ Time Frame: 24, 48, 72 hours ] 
Level of serum lactate at 24, 48, 72 h 
6 
• Days on ventilator, vasopressor and renal replacement therapy [ Time Frame: until 
day 30 post-surgery ] 
Total days on ventilator, vasopressor and renal replacement therapy within 30 days 
post-surgery will be assessed 
7 
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight) [Time: first 72 
hours] 
Secondary results  
1 
Inflammatory response -  The level of C-reactive protein (CRP) [Time: 24-48 hours] 
The level of C-reactive protein (CRP) before the start of ECMO, 2 hours after the 
implantation of ECMO, during ECMO, 24 hours after ECMO explantation. 
2 
Inflammatory response - The level of leukocytes [Time: 24-48 hours] 
The level of leukocytes before the start of ECMO, 2 hours after the implantation of 
ECMO, during ECMO, 24 hours after ECMO explantation. 
3 
Inflammatory response - The level of procalcitonin [Time: 24-48 hours] 
The level of procalcitonin before the start of ECMO, 2 hours after the implantation of 
ECMO, during ECMO, 24 hours after ECMO explantation. 
4 
Level of leukocyte [Time: 24-48 hours] 
 Level of leukocyte cells in the bloodstream at 24, 48 hours. 

5 
Application and dosage of vasopressors [Deadline: first 48 hours] 
Incidence of application and level of dosage of vasopressors on days 2 and 3 after 
surgery; 
6 
Application and dosage of inotropes [Deadline: first 48 hours] 
Incidence of application and level of dosage of inotropes on days 2 and 3 after 
surgery; 
Long-term results 
1 
Length of stay in the intensive care unit [Duration: first 48 hours] 
2 
Length of hospital stay [Term: up to 1 month]; 
3 
30 day survival rate. 
 
Patients with left ventricular assist device implantation  
Primary results 
   1 
Difference of Cytokine response [Time: 24-48 hours] 
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor 
necrosis factor-alfa, procalcitonin)  
2 
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight) 
 [Deadline: first 72 hours] 
3 
Renal function [Time: first 72 hours] creatinine level 
4 
Lactate level [Time: first 72 hours] 
Secondary results  
1 
Inflammatory response - The level of C-reactive protein (CRP) [Time: 24-48 hours] 
The level of C-reactive protein (CRP) before the start of the operation, 2 hours after 
the start of the operation, when the operation is turned off, 24 hours after the 
shutdown of the operation 
2 
Inflammatory response - The level of leukocytes [Time: 24-48 hours] 
The level of leukocytes before the start of the operation, 2 hours after the start of 
the operation, when the operation is turned off, 24 hours after the shutdown of the 
operation 
3 
Inflammatory response - The level of procalcitonin [Time: 24-48 hours] 
The level of procalcitonin before the start of the operation, 2 hours after the start of 
the operation, when the operation is turned off, 24 hours after the shutdown of the 
operation 

4 
Application and dosage of vasopressors [Deadline: first 48 hours] 
Incidence of application and level of dosage of vasopressors on days 2 and 3 after 
surgery; 
5 
Application and dosage of inotropes [Deadline: first 48 hours] 
Incidence of application and level of dosage of inotropes on days 2 and 3 after 
surgery; 
Long-term results 
1 
Length of stay in the intensive care unit [Duration: first 48 hours] 
2 
Length of hospital stay [Term: up to 1 month]; 
3 
30 day survival rate. 
 
For operations with prolonged cardio pulmonary bypass, hypothermia and 
circulatory arrest 
Primary results 
1 
Cytokine response [Time: 24-48 hours] 
Difference of Cytokine response [Time: 24-48 hours] 
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor 
necrosis factor-alfa, procalcitonin, C-reactive protein)  
2 
SOFA-Score [Time Frame: 24, 48, 72 hours] 
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, 
where the higher values explain higher disease severity) 
3 
Difference of mean arterial pressure [Time Frame: 24, 48, 72 hours] 
Comparison of mean arterial pressure at 24, 48, 72 hours between between two 
interventions (CytoSorb and Jafron) 
4 
Difference of CVP [Time Frame: 24, 48, 72 hours] 
Comparison of mean arterial pressure at 24, 48, 72 hours between between two 
interventions (CytoSorb and Jafron) 
5 
Level of Serum lactate [ Time Frame: 24, 48, 72 hours ] 
Comparison of mean arterial pressure at 24, 48, 72 hours between between two 
interventions (CytoSorb and Jafron) 
Secondary results  
1 
Inflammatory response - The level of C-reactive protein (CRP) [Time: 24-48 hours] 
The level of C-reactive protein (CRP) before the cardiopulmonary bypass  2 hours 

after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 
24 hours after the cardiopulmonary bypass. 
2 
Inflammatory response - The level of leukocytes [Time: 24-48 hours] 
The level of leukocytes before the cardiopulmonary bypass  2 hours after the 
cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours 
after the cardiopulmonary bypass. 
3 
Inflammatory response - The level of procalcitonin [Time: 24-48 hours] 
The level of procalcitonin before the cardiopulmonary bypass  2 hours after the 
cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours 
after the cardiopulmonary bypass. 
4 
Application and dosage of vasopressors [Deadline: first 48 hours] 
Incidence of application and level of dosage of vasopressors on days 2 and 3 after 
surgery; 
5 
Application and dosage of inotropes [Deadline: first 48 hours] 
Incidence of application and level of dosage of inotropes on days 2 and 3 after 
surgery; 
Long-term results 
1 
Length of stay in the intensive care unit [Duration: first 48 hours] 
2 
Length of hospital stay [Term: up to 1 month]; 
3 
30 day survival rate. 
 
Statistical research 
1) statistical data processing 
2) comparison and analysis of initial data 
After data acquisition, statistical analysis will be performed using SPSS Statistics 
version 22. For quantitative data, the nonparametric Mann-Whitney Yu test and parametric t-
test will be performed, and for qualitative studies, the nonparametric Fisher's exact test and 
the parametric χ2 test will be performed. Also, logistic regression for categorical outcomes 
and survival analyzes (non-parametric Kaplan-Meyer and parametric Cox regression) will be 
performed. 
Age: 18 years and older  
Gender: All 
Inclusion of healthy volunteers: Not 

 
Groups  
Inclusion criteria  
Exclusion criteria 
Patients 
on 
an 
extracorporeal 
life 
support 
system 
with 
heart failure 
• Implantation 
of 
intravenous 
ECMO 
• Hemodynamic 
support 
with 
vasopressors and / or tonics; 
• Procalcitonin level ≥ 1 ng / ml; 
• Invasive 
hemodynamic 
monitoring; 
• Written informed consent. 
• Age less than 18 years old 
•  Terminal hepatic or renal 
failure 
just 
before 
the 
procedure 
• Patient's written refusal to 
participate in the study 
Patients 
on 
an 
extracorporeal 
life 
support 
system 
with 
pulmonary failure 
• IV ECMO implantation 
• High levels of venous and 
arterial 
CO2 
(CO2> 
50 
mmHg), 
• Low paO2, SvO2, SpO2. 
• Invasive 
hemodynamic 
monitoring; 
• Written informed consent. 
• Age less than 18 years old 
• Terminal hepatic or renal 
failure 
just 
before 
the 
procedure 
• Patient's written refusal to 
participate in the study 
Patients 
with 
left 
ventricular 
assistive 
device implantation  
 
• LVAD implantation 
• Biventricular heart failure IV 
• INTERMACS I-III 
• Hemodynamic 
support 
with 
vasopressors and / or tonics; 
• Procalcitonin level ≥ 0.1 ng / ml; 
• Invasive 
hemodynamic 
monitoring; 
• Written informed consent. 
• Age less than 18 years old 
• Acute hepatic or renal failure 
just before the procedure 
• Patient's written refusal to 
participate in the study 
Patients in operations 
with prolonged artificial 
circulation, hypothermia 
and circulatory arrest 
• Hemodynamic 
support 
with 
vasopressors and / or tonics; 
• Bypass duration> 120 minutes 
• Hypothermia ≤ 25 0С 
• Circulatory arrest 
• Age less than 18 years old 
• Terminal hepatic or renal 
failure 
just 
before 
the 
procedure 
• Patient's written refusal to 

• Procalcitonin level ≥ 1 ng / ml; 
• Invasive 
hemodynamic 
monitoring; 
• Written informed consent. 
participate in the study 
 
The study will be conducted in accordance with the international standards Good 
Clinical Practice, Joint Commission International, scientific ethics (Declaration of Helsinki), 
as well as the Order of the Minister of Health of the Republic of Kazakhstan dated December 
11, 2020 No. 248 ―On approval of the rules for conducting clinical trials of drugs and 
medical devices, clinical laboratory testing of medical devices for diagnostics outside of a 
living organism (in vitro) and requirements for clinical bases and provision of public 
services. Issuance of a permit for conducting a clinical trial and (or) testing of 
pharmacological and medicinal products, medical devices. " The study will also take place in 
accordance with the recommendations of the Local Ethics Commission at Non-profit JSC 
«NRCCS». All patients will receive a voluntary informed consent of the established form 
with permission to use clinical data for scientific purposes. In addition, the research will be 
strictly monitored by the researchers to ensure that it is free from plagiarism, falsification and 
fabrication of data in order to achieve the highest ethical conduct of the research. The 
resulting patient data will be strictly confidential with ensuring privacy through strictly 
limited access to data, de-identification of data and destruction after the end of the study. 
 

5. Research team and program management 
 
No
. 
Full 
name 
(degree, 
academic title) 
Main place of 
work, position 
Role in the program 
Employment 
Project work period (months) 
1st year 
2nd year 
3rd year 
1 
 
Pya  
Yuri 
Vladimirovich 
 
 
Non-profit JSC 
―NRCCS‖ 
Director of Science 
and Surgery  
Leader 
Scientific supervisor of the project. 
General project management, 
definition of the vision and 
direction of the project, 
participation in the analysis of 
results, participation in the 
preparation of publications 
Part-time  
 
 
 
12 
 
 
 
12 
 
 
 
12 
2 
Lesbekov  
Timur 
 Dostaevich 
Non-profit JSC 
―NRCCS‖ 
Head of the 
Department of 
Cardiac Surgery 
Co-leader 
General project management, 
definition of the vision and 
direction of the project, 
participation in the analysis of 
results, participation in the 
preparation of publications 
Part-time 
 
 
 
12 
 
 
 
12 
 
 
 
12 
3 
Kaliev  
Non-profit JSC 
Leading researcher 
Part-time 
 
 
 

Rymbay  
Bolatovich  
―NRCCS‖ 
Head of the 
operating 
department with a 
laboratory for 
circulatory support 
Selection of patients, analysis of 
clinical data, development of a 
quality of life questionnaire. 
Participation in the analysis of 
results and preparation of 
publications, methods, including 
methods of prevention. 
 
 
12 
 
 
12 
 
 
12 
4 
Nurmykhametova 
Zhuldyz 
Askarovna 
Non-profit JSC 
―NRCCS‖ 
Physician 
perfusionist of the 
operating 
department with a 
laboratory for 
circulatory support 
Secondary researcher 
Selection of patients, analysis of 
clinical data, development of a 
quality of life questionnaire. 
Participation in the analysis of 
results and preparation of 
publications, methods, including 
methods of prevention 
Part-time 
 
 
 
12 
 
 
 
12 
 
 
 
12 
5 
Kuanyshbek 
Aydin Sayatovich 
 
Non-profit JSC 
―NRCCS‖ 
Head of the 
Department of 
Anesthesiology, 
Secondary researcher 
Selection of patients, analysis of 
clinical data, development of a 
quality of life questionnaire. 
Participation in the analysis of 
results and preparation of 
Part-time 
 
 
 
12 
 
 
 
12 
 
 
 
12 

Reanimation and 
Intensive Care 
publications, methods, including 
methods of prevention 
6 
Dzhabaeva 
Nilufar 
Amirbekovna 
Non-profit JSC 
―NRCCS‖ 
Doctor 
nephrologist 
Extracorporeal 
hemocorrection 
laboratories  
 
SNS 
Selection of patients, analysis of 
clinical data, development of a 
quality of life questionnaire. 
Participation in the analysis of 
results and preparation of 
publications, methods, including 
methods of prevention 
Part-time 
 
 
 
12 
 
 
 
12 
 
 
 
12 
7 
Faizov 
Linar 
Renatovich 
 
Non-profit JSC 
―NRCCS‖ 
Physician 
perfusionist of the 
operating 
department with a 
laboratory for 
circulatory support 
SNS 
Selection of patients, analysis of 
clinical data, development of a 
quality of life questionnaire. 
Participation in the analysis of 
results and preparation of 
publications, methods, including 
methods of prevention 
Part-time 
 
 
 
12 
 
 
 
12 
 
 
 
12 
8 
Position 
 
Economic calculations, preparation 
of interim and annual reports 
Part-time 
 
 
 
 
 
 

12 
12 
 
12 
9 
Iskakova 
Ainel 
Talgatovna 
Non-profit JSC 
―NRCCS‖ 
Chief Specialist  
Department of 
Science  
Organizational project 
management, preparation of semi-
annual acts, reports.  
Part-time 
 
 
12 
 
 
12 
 
 
12 
10 
Position 
 
Statistical processing of the 
obtained research data  
Part-time 
 
 
 
 
 
11 
Position 
 
Statistical processing of the 
obtained research data  
Part-time 
 
 
 
 
 
 
 

 
In total, 11 specialists in the field of cardiac surgery, perfusion, cardiology, 
anesthesiology, efferentology, and public health are involved in the project.  
Principal Investigator - Yuriy Vladimirovich Pya - Director for Surgery and Science of 
the National Research Center for Cardiac Surgery, a graduate of the 2nd Moscow State 
Medical Institute named after V.I. NI Pirogova, international cardiac surgeon, associate 
professor, doctor of medical sciences. Winner of a number of state awards, including the 
Order of the Republic of Kazakhstan "Parasat", "Doctor of the Year 2012", the honorary title 
"Kazakhstan Enbek Erі". The supervisor will be involved throughout the entire research 
period. According to Scopus, the Hirsch index - 10, Author ID in Scopus - 7801690331. 
Proncipal Investigator of the projects: 
1. Scientific project Committee of Sсience of the Ministry of education and sсience of 
Republic of Kazakhstan 2018-2020 on the topic "Study of the effectiveness of a new 
method of conditioning for the preservation of the donor heart"; 
2. Scientific program Targeted program financing of the Ministry of Health of the 
Republic of Kazakhstan 2017-2019 on the topic "New molecular genetic methods of 
pre-symptomatic diagnostics and methods of treatment of a number of significant 
diseases", Surgical treatment of CHF; 
3. Y. Pya, A. Medressova, S. Bekboыsynov, dated August 25, 2020, No. US 10,751,456 
B2, METHOD OF IMPLANTATION OF LEFT VENTRICULAR MECHANICAL 
ASSIST DEVICE HEARTMATE III (US Patent Office); 
4. Y. Pya, A. Medressova, S. Bekbossynov, dated November 16, 2020, No. 201800238 
Method of implantation of a device for mechanical support of the left ventricle 
HEARTMATE 3 (Eurasian Patent Office). 
Co-head of the program - Timur Dostaevich Lesbekov, Candidate of Medical 
Sciences, Head of the Department of Cardiac Surgery, Non-profit JSC «NRCCS». According 
to Scopus, the Hirsch index - 2, the Author ID in Scopus - 6505523476. 
Kaliev Rymbay Bolatovich - head of the operating department with the laboratory of 
auxiliary blood circulation, Non-profit JSC «NRCCS». According to Scopus, Hirsch index is 
3, Author ID in Scopus - 57053326800.  
Kuanyshbek Aydin Sayatovich - Head of the Department of Anesthesiology, 
Reanimation and Intensive Care of the Non-profit JSC «NRCCS». According to Scopus, 
Hirsch index - 1, Author ID in Scopus -57221294150. 

Nurmykhametova Zhuldyz Askarovna - doctor perfusionist of the operating 
department with a laboratory for auxiliary circulation of the Non-profit JSC «NRCCS». 
According to Scopus, Hirsch index - 1, Author ID in Scopus -57221292855. 
Faizov Linar Renatovich - doctor perfusionist of the operating department with the 
laboratory of auxiliary circulation of the Non-profit JSC «NRCCS». According to Scopus, 
Hirsch index - 2, Author ID in Scopus - 57194181173. 
 
List of international publications (last): 
1 
Medressova, A., Faizov, L., Kuanyshbek, A., Kaliyev, R., Myrzakhmetova, G., la 
Fleur, P., Pya, Y. Successful heart transplantation after 17 h ex vivo time using the 
Organ Care System—3 years follow-up//Journal of Cardiac Surgery, 2021 (in 
press) (52 percentile, Scopus) 
2 
Zimpfer, D., Gustafsson, F., Potapov, E., Pya, Y., Schmitto, J., Berchtold-Herz, 
M., Garbade, J. (2020). Two-year outcome after implantation of a full 
magnetically levitated left ventricular assist device: Results from the ELEVATE 
registry. 
European 
Heart 
Journal, 
41(39), 
3801-3809. 
doi:10.1093/eurheartj/ehaa639 (99 percentile, Scopus) 
3 
Pya, Y., Netuka, I., Latremouille, C., Bekbossynova, M., Medressova, A., 
Bekbossynov, S., Salov, R., & Hetzer, R. (2020). CARMAT total artificial heart 
implantation: report on the first successful clinical experience as bridge to heart 
transplantation. Cardiovascular Diagnosis And Therapy, 0. doi:10.21037/cdt-20-
353 (63 percentile, Scopus) 
4 
Mirza, Kiran & Gustafsson, F. & Pya, Y. & Shaw, S. & Diegeler, A. & Netuka, I. 
& Lavee, Jacob & Garbade, Jens & Morshuis, M. & Heatley, J. & Saeed, Diyar & 
Potapov, Evgenij & Schmitto, Jan & Zimpfer, Daniel. (2019). Atrial Fibrillation is 
a Predictor of Poor Physical Capacity 6 Months after Implantation of a Full 
Magnetically Levitated Left Ventricular Assist Device: An Analysis from 
ELEVATE. The Journal of Heart and Lung Transplantation. 38. S45. 
10.1016/j.healun.2019.01.095. (99 percentile, Scopus) 
5 
Netuka, I. & Pya, Y. & Zimpfer, Daniel & Potapov, E. & Garbade, Jens & Rao, V. 
& Morshuis, M. & Marasco, S. & Beyersdorf, F. & Gazzola, C. & Sood, P. & 
Schmitto, Jan. (2020). First Long-Term 5-years experience with the HeartMate 3 
LVAS in Multicentric Clinical Trial. The Journal of Heart and Lung 

Transplantation. 39. S184. 10.1016/j.healun.2020.01.768. (99 percentile, Scopus) 
6 
Loforte, Antonio & Gliozzi, G. & Potapov, E. & Mariani, Carlo & Schoenrath, 
Felix & Netuka, I. & Pya, Y. & Gummert, Jan & Meyns, B. & Pacini, Doreen & 
By, T.M.M.H.. (2020). Concomitant Cardiac Procedures during Implantation of 
Long-Term Continuous-Flow LVADs: A European Registry for Patients with 
Mechanical Circulatory Support (EUROMACS) Analysis. The Journal of Heart 
and Lung Transplantation. 39. S122-S123. 10.1016/j.healun.2020.01.1009. (99 
percentile, Scopus) 
7 
Kaliyev, R., Lesbekov, T., Bekbossynov, S. Samalavicius, R., Pya, Y. 
Comparison of Custodiol vs warm blood cardioplegia and conditioning of donor 
hearts during transportation with the organ care system//Journal of Cardiac 
Surgery, 2019, 34(10), с. 969-975 (52 процентиль, Scopus) 
8 
R. Kaliyev, S. Bekbossynov, Zh. Nurmykhametova. Sixteen‐Hour Ex Vivo Donor 
Heart 
Perfusion 
During 
Long‐Distance 
Transportation 
for 
Heart 
Transplantation//Artificial organs – 43(3), 2019, с. 319-320 (60 percentile, 
Scopus) 
9 
Пя Ю.В., Калиев Р.Б., Лесбеков Т.Д., Бекбосынов С.Т., Капышев Т.С., 
Нурмыхаметова Ж.А., Смагулов Н.К., Аширов Ж.З., Фаизов Л.Р. Программа 
экстракорпоральной мембранной оксигенаций в Казахстане: ближайшие 
результаты // «Журнал им. акад. Б.В. Петровского Клиническая и 
экспериментальная хирургия» - №1-2017 г. С. 41-45 (6 percentile, Scopus) 
10 
Пя Ю.В., Калиев Р.Б., Бекбосынов С.Т., Лесбеков Т.Д., Нурмыхаметова Ж.А., 
Смагулов Н.К., Новикова С.П., Аширов Ж.З., Фаизов Л.Р., Медресова А.Т., 
Мурзагалиева М.О. Новый метод сохранения донорского сердца с 
использованием кровяной кардиоплегии и кондиционирования // «Журнал 
им. акад. Б.В. Петровского Клиническая и экспериментальная хирургия» - 
№3-2017 г. С. 54-60  (6 percentile, Scopus) 
 
Пя Ю.В., Бекбосынов С.Т., Бекбосынова М.С., Куатбаев Е.М.,Лесбеков Т.Д., 
Калиев Р.Б., Джетыбаева С.К., Медресова А.Т., Нурмыхаметова Ж.А., 
Мурзагалиев М.У., Новикова С.П., Капышев Т.С.,Смагулов Н.К., Фаизов 
Л.Р., Вахрушев И.А., Андосова С.А.,Мырзахметова Г.Ш., Надирбекова Г.Е., 
Шайсултанова С.Т., Дюсенбина Ж.С. Программа трансплантации сердца в 
эпоху 
механической 
поддержки 
кровообращения: 
опыт 
Республики 

Казахстан // «Журнал им. акад. Б.В. Петровского Клиническая и 
экспериментальная хирургия» - №3-2017 г. С. 49-54(6 percentile, Scopus) 
 
 

 
8. Plan for the implementation of the program. 
 
P / 
p 
No. 
Name of tasks and 
measures for their 
implementation 
Start of 
execution 
(dd / mm / 
yy) 
Duration, 
months 
Expected results of the program implementation (in the context of tasks and activities), 
completion form 
1st year 
2nd year 
3rd year 
1 
2 
4 
5 
6 
7 
8 
1 
Literature review on 
organ replacement 
technology in the 
treatment of patients with 
heart and pulmonary 
insufficiency 
2021 
9  
A literature review on organ 
replacement technology in 
the treatment of patients with 
heart and lung failure will be 
obtained. 
 
 
1.1 
A review of the literature 
on the restoration of 
organ function when 
using extracorporeal life 
support systems as an 
organ-substituting aid for 
heart and pulmonary 
2021 
3 
A review of the literature on 
the restoration of organ 
function using extracorporeal 
life support systems as an 
organ-substituting aid for 
heart and pulmonary failure 
will be obtained. 
 
 

failure. 
1.2 
Literature review on 
implantation of 
mechanical circulatory 
devices using an 
extracorporeal cytokine 
adsorber 
2021 
3 
A literature review on the 
implantation of mechanical 
circulatory devices using an 
extracorporeal cytokine 
adsorber will be obtained. 
 
 
1.3 
Literature review on the 
use of an extracorporeal 
cytokine adsorber in 
operations with 
prolonged artificial 
circulation, hypothermia 
and circulatory arrest 
2021 
3 
A literature review will be 
obtained on the use of an 
extracorporeal cytokine 
adsorber in operations for 
reconstructing the aortic arch 
with hypothermia and 
cardiopulmonary bypass. 
 
 
2 
Based on the literature 
review, conduct a 
comparative assessment 
of the application of 
methods of 
extracorporeal 
hemoadsorption in 
2021 
9 
Comparative evaluation will 
be carried out on the 
application of methods of 
extracorporeal 
hemoadsorption in 
pulmonary and heart failure  
 
 

pulmonary and heart 
failure 
3 
Patient recruitment  
2021 
 
Patient recruitment for the 
study will begin 
Patient recruitment will 
continue 
Patient recruitment will 
continue 
3.1 
Recruiting of patients 
using extracorporeal life 
support systems as an 
organ-substituting aid for 
heart and pulmonary 
failure. 
2021 
36 
Recruiting of patients using 
extracorporeal life support 
systems as an organ-
substituting aid for heart and 
pulmonary failure. 
Recruiting of patients when 
using extracorporeal life 
support systems, as an 
organ-substituting aid, with 
heart and pulmonary failure 
will continue 
Recruiting of patients when 
using extracorporeal life 
support systems, as an organ-
substituting aid, with heart 
and pulmonary failure will 
continue 
3.2 
Recruiting of patients for 
implantation of 
mechanical circulatory 
devices using an 
extracorporeal cytokine 
adsorber 
2021 
36 
Recruiting will begin patients 
with implantation of 
mechanical circulatory 
devices using an 
extracorporeal cytokine 
adsorber 
Recruiting patients for 
implantation of mechanical 
circulatory devices using an 
extracorporeal cytokine 
adsorber will continue 
Recruiting patients for 
implantation of mechanical 
circulatory devices using an 
extracorporeal cytokine 
adsorber will continue 
3.3 
Recruiting of patients for 
hypothermia and 
cardiopulmonary bypass 
reconstruction with an 
extracorporeal cytokine 
2021 
36 
Will be started recruiting of 
patients for reconstructions 
of the aortic arch with 
hypothermia and 
cardiopulmonary bypass 
Recruiting of patients for 
hypothermia and 
cardiopulmonary bypass 
reconstruction with an 
extracorporeal cytokine 
Recruiting of patients for 
hypothermia and 
cardiopulmonary bypass 
reconstruction with an 
extracorporeal cytokine 

adsorber  
using an extracorporeal 
cytokine adsorber 
adsorber will continue 
adsorber will continue 
4 
 Collection of laboratory 
and clinical data 
2021 
36 
There will be a collection 
laboratory and clinical data 
There will be a collection 
laboratory and clinical data 
There will be a collection 
laboratory and clinical data 
4.1 
Collection of laboratory 
and clinical data, blood 
sampling for pro- and 
anti-inflammatory 
cytokines, assessment of 
organ dysfunction, dose 
of vasopressors after 
implantation of 
extracorporeal life 
support systems as an 
organ-substituting aid for 
pulmonary failure 
2021 
36 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, dose of 
vasopressors after 
implantation of 
extracorporeal life support 
systems as an organ-
substituting aid for 
pulmonary failure 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, dose of 
vasopressors after 
implantation of 
extracorporeal life support 
systems as an organ-
substituting aid for 
pulmonary failure 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, dose of 
vasopressors after 
implantation of extracorporeal 
life support systems as an 
organ-substituting aid for 
pulmonary failure 
4.2 
Collection of data on the 
inflammatory response, 
leukocyte function, doses 
of inotropic support after 
implantation of 
2021 
36 
There will be a collection 
data on inflammatory 
response, leukocyte function, 
doses of inotropic support 
after implantation of 
There will be a collection 
data on inflammatory 
response, leukocyte 
function, doses of inotropic 
support after implantation of 
There will be a collection data 
on inflammatory response, 
leukocyte function, doses of 
inotropic support after 
implantation of extracorporeal 

extracorporeal life 
support systems as an 
organ-substituting aid for 
pulmonary failure 
extracorporeal life support 
systems as an organ-
substituting aid for 
pulmonary failure 
 
extracorporeal life support 
systems as an organ-
substituting aid for 
pulmonary failure 
 
life support systems as an 
organ-substituting aid for 
pulmonary failure 
 
4.3 
Long-term results 
collection: length of stay 
in the intensive care unit, 
30 day survival after 
implantation of 
extracorporeal life 
support systems as an 
organ-substituting aid for 
pulmonary failure 
2021 
36 
Long-term results will be 
collected: length of stay in 
the intensive care unit, 30 
day survival after 
implantation of 
extracorporeal life support 
systems as an organ-
substituting aid for 
pulmonary failure 
Long-term results will be 
collected: length of stay in 
the intensive care unit, 30 
day survival after 
implantation of 
extracorporeal life support 
systems as an organ-
substituting aid for 
pulmonary failure 
Long-term results will be 
collected: length of stay in the 
intensive care unit, 30 day 
survival after implantation of 
extracorporeal life support 
systems as an organ-
substituting aid for pulmonary 
failure 
4.4 
Collection of laboratory 
and clinical data, blood 
sampling for pro- and 
anti-inflammatory 
cytokines, assessment of 
organ dysfunction, dose 
of vasopressors after 
2021 
36 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, doses of 
vasopressors after 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, doses of 
vasopressors after 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, doses of 
vasopressors after 

implantation of 
extracorporeal life 
support systems as an 
organ-substituting aid in 
heart failure 
implantation of 
extracorporeal life support 
systems as an organ-
substituting aid in heart 
failure 
implantation of 
extracorporeal life support 
systems as an organ-
substituting aid in heart 
failure 
implantation of extracorporeal 
life support systems as an 
organ-substituting aid in heart 
failure 
4.5 
Collection of data on 
inflammatory response, 
leukocyte function, doses 
of inotropic support after 
implantation of 
extracorporeal life 
support systems as an 
organ-substituting aid in 
heart failure 
2021 
36 
There will be a collection 
data on inflammatory 
response, leukocyte function, 
doses of inotropic support 
after implantation of 
extracorporeal life support 
systems as organ-substituting 
benefits for heart failure  
There will be a collection 
data on inflammatory 
response, leukocyte 
function, doses of inotropic 
support after implantation of 
extracorporeal life support 
systems as organ-
substituting benefits for 
heart failure 
There will be a collection data 
on inflammatory response, 
leukocyte function, doses of 
inotropic support after 
implantation of extracorporeal 
life support systems as organ-
substituting benefits for heart 
failure 
4.6 
Long-term results 
collection: length of stay 
in the intensive care unit, 
30 day survival after 
implantation of 
extracorporeal life 
support systems as an 
2021 
36 
There will be a collection 
long-term results: length of 
stay in the intensive care 
unit, 30 day survival after 
implantation of 
extracorporeal life support 
systems as an organ-
There will be a collection 
long-term results: length of 
stay in the intensive care 
unit, 30 day survival after 
implantation of 
extracorporeal life support 
systems as an organ-
There will be a collection 
long-term results: length of 
stay in the intensive care unit, 
30 day survival after 
implantation of extracorporeal 
life support systems as an 
organ-substituting aid for 

organ-substituting aid for 
heart failure 
substituting aid for heart 
failure  
substituting aid for heart 
failure 
heart failure 
4.7 
Collection of laboratory 
and clinical data, blood 
sampling for pro- and 
anti-inflammatory 
cytokines, assessment of 
organ dysfunction, dose 
of vasopressors after 
implantation of an 
auxiliary device of the 
left ventricle and 
implantation of a 
completely artificial heart 
as an organ-replacing aid 
in case of heart failure. 
2021 
36 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, dose of 
vasopressors after 
implantation of an auxiliary 
device of the left ventricle 
and implantation of a 
completely artificial heart as 
an organ-replacing aid in 
case of heart failure 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, dose of 
vasopressors after 
implantation of an auxiliary 
device of the left ventricle 
and implantation of a 
completely artificial heart as 
an organ-replacing aid in 
case of heart failure 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
assessment of organ 
dysfunction, dose of 
vasopressors after 
implantation of an auxiliary 
device of the left ventricle and 
implantation of a completely 
artificial heart as an organ-
replacing aid in case of heart 
failure 
4.8 
Data collection of 
inflammatory response, 
leukocyte function, 
inotropic support doses  
after implantation of an 
2021 
36 
There will be a collection 
inflammatory response data, 
leukocyte function, inotropic 
support doses after 
implantation of an auxiliary 
There will be a collection 
inflammatory response data, 
leukocyte function, inotropic 
support doses after 
implantation of an auxiliary 
There will be a collection 
inflammatory response data, 
leukocyte function, inotropic 
support doses after 
implantation of an auxiliary 

auxiliary device of the 
left ventricle and 
implantation of a 
completely artificial heart 
as an organ-replacing aid 
in case of heart failure. 
device of the left ventricle 
and implantation of a 
completely artificial heart as 
an organ-replacing aid in 
case of heart failure. 
device of the left ventricle 
and implantation of a 
completely artificial heart as 
an organ-replacing aid in 
case of heart failure. 
device of the left ventricle and 
implantation of a completely 
artificial heart as an organ-
replacing aid in case of heart 
failure. 
4.9 
Long-term data 
collection: length of stay 
in the intensive care unit, 
30 day survival after  
implantation of an 
auxiliary device of the 
left ventricle and 
implantation of a 
completely artificial heart 
as an organ-replacing aid 
in case of heart failure. 
2021 
36 
There will be a collection 
long-term results: length of 
stay in the intensive care 
unit, 30 day survival after 
implantation of an auxiliary 
device of the left ventricle 
and implantation of a 
completely artificial heart as 
an organ-replacing aid in 
case of heart failure.  
There will be a collection 
long-term results: length of 
stay in the intensive care 
unit, 30 day survival after 
implantation of an auxiliary 
device of the left ventricle 
and implantation of a 
completely artificial heart as 
an organ-replacing aid in 
case of heart failure. 
There will be a collection 
long-term results: length of 
stay in the intensive care unit, 
30 day survival after 
implantation of an auxiliary 
device of the left ventricle and 
implantation of a completely 
artificial heart as an organ-
replacing aid in case of heart 
failure. 
4.10 
Collection of laboratory 
and clinical data, blood 
sampling for pro- and 
anti-inflammatory 
2021 
36 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 
There will be a collection 
laboratory and clinical data, 
blood sampling for pro- and 
anti-inflammatory cytokines, 

cytokines, assessment of 
organ dysfunction, dose 
of vasopressors during 
operations with 
prolonged artificial 
circulation, hypothermia 
and circulatory arrest, as 
an organ-substituting aid 
assessment of organ 
dysfunction, dose of 
vasopressors after 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
assessment of organ 
dysfunction, dose of 
vasopressors after 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
assessment of organ 
dysfunction, dose of 
vasopressors after 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
4.11 
Collection of data on 
inflammatory response, 
leukocyte function, 
inotropic support doses 
during operations with 
prolonged artificial 
circulation, hypothermia 
and circulatory arrest, as 
an organ-substituting aid  
2021 
36 
There will be a collection 
inflammatory response data, 
leukocyte function, inotropic 
support doses after 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
There will be a collection 
inflammatory response data, 
leukocyte function, inotropic 
support doses after 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
There will be a collection 
inflammatory response data, 
leukocyte function, inotropic 
support doses after 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
4.12 
Long-term data 
collection: length of stay 
in the intensive care unit, 
30 day survival after 
2021 
36 
There will be a collection 
long-term results: length of 
stay in the intensive care 
unit, 30 day survival after 
There will be a collection 
long-term results: length of 
stay in the intensive care 
unit, 30 day survival after 
There will be a collection 
long-term results: length of 
stay in the intensive care unit, 
30 day survival after 

operations with long-term 
artificial circulation, 
hypothermia and 
circulatory arrest, as an 
organ-substituting aid 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
reconstruction of the aortic 
arch with long-term artificial 
circulation and hypothermia, 
as an organ-replacing aid 
5 
Analysis of clinical and 
laboratory data on the 
restoration of organ 
function using innovative 
technologies 
2022 
24 
 
An analysis of clinical and 
laboratory data on the 
restoration of organ function 
will be carried out using 
innovative technologies 
An analysis of clinical and 
laboratory data on the 
restoration of organ function 
will be carried out using 
innovative technologies 
6 
Statistical processing and 
analysis of the obtained 
data 
2022 
24 
 
Statistical processing of the 
obtained research results 
will be carried out 
Statistical processing of the 
obtained research results will 
be carried out 
7 
Determination of an 
effective method of 
treating heart and 
pulmonary failure using 
organ replacement 
technologies. 
2023 
12 
 
 
An effective method will be 
determined of the treatment of 
heart and pulmonary failure 
using organ replacement 
technologies 
8 
Development of 
innovative methods of 
2022 
24 
 
Innovative methods of 
treating patients using 
Innovative methods of 
treating patients using organ-

treating patients using 
organ-replacing 
technologies 
 
organ-replacing technologies 
will be developed 
 
replacing technologies will be 
developed 
 
9 
Development of practical 
protocols for the 
restoration of organ 
function 
 
2022 
24 
 
Practical protocols to restore 
organ function will be 
developed 
  
Practical protocols to restore 
organ function will be 
developed 
 
10 
Implementation of patient 
treatment protocols using 
organ-replacing 
technologies 
2023 
12 
 
 
Patient treatment protocols 
using organ-replacing 
technologies will be 
introduced 
11 
Writing and submission 
of interim and final 
reports 
2021 
36 
Interim report will be 
prepared  
Interim report will be 
prepared 
Final report will be prepared 
12 
Preparation of 
publications, reports 
2022 
24 
 
Publications will be 
prepared  
Publications will be prepared 

 
9. Expected results of the program. 
 
Direct results: 
The obtained results of the study will form the basis for practical protocols for the use 
of extracorporeal life support systems, operations for the implantation of left ventricular 
assistive devices and a completely artificial heart. 
The obtained protocols will be implemented in the treatment of patients using organ-
replacing technologies and will be documented. 
As part of the study, innovative methods of treating patients using organ-replacing 
technologies will be developed: 
- with the implantation of a completely artificial heart, as an organ-replacing aid, in 
case of heart failure; 
- with implantation of an auxiliary device of the left ventricle, as an organ-replacing 
aid, in case of heart failure;  
- when using extracorporeal life support systems in the treatment of pulmonary and / or 
heart failure. 
The developed methods will be used as new standards and recommendations for the 
treatment of heart and pulmonary failure.  
The developed recommendations will form the basis for a number of educational events 
within the framework of the ECMO School with the involvement of specialists from all 
regions of the country. 
Will be published at least 2 (two) articles and (or) reviews in peer-reviewed scientific 
journals in the scientific direction of the program included in the 1 (first), 2 (second) or 3 
(third) quartiles in the Web of Science database and (or) having a percentile CiteScore in the 
Scopus database is at least 50 (fifty). 
The results of the study can help to reduce the rate of postoperative mortality in critically 
ill patients with pulmonary and / or heart failure by 30%. 
To popularize science, a separate website will be created, which will provide complete 
information on the progress of the program. For each scientific publication within the 
framework of the program, information will be published on the website and / or in social 
networks. 
 
 

End results:  
In general, the expected efficiency and effectiveness of the proposed project will make a 
significant contribution to the development of the health care system in Kazakhstan, namely, 
to improve organ recovery, reduce postoperative complications, reduce postoperative 
mortality and improve the quality of life of patients. 
The data obtained on the treatment of patients with heart and pulmonary failure through 
the use of innovative technologies will provide the necessary information to improve the 
quality of tertiary medical care and the quality of life of patients in Kazakhstan and around 
the world. 
This project is aimed at achieving the indicators of the State Program for Healthcare 
Development 2020-2025. An increase in the average life expectancy of population up to 75 
years and a decrease in the risk of premature mortality from 30 to 70 years from 
cardiovascular diseases. 
 In addition, the results will lead to modernization and an increase in the share of 
innovative organ-replacing technologies in the health care system.  
 
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