PHARMACEUTICAL MARKET OF CARDIOPLEGIC DRUGS AND FEATURES OF THEIR APPLICATION IN RUSSIA

Relevance. Surgical treatment of cardiovascular diseases with the use of artificial blood circulation is associated with the need to protect the myocardium. Various cardioplegic solutions are widely used in cardiac surgery to stop and protect the heart. Currently, a significant number of mixtures of drug solutions are used in "open" heart surgery. However, not all of them have been officially registered as cardioplegic solutions and not all have the appropriate indications in the instructions for medical use of the drug, which jeopardizes the safety and quality of medical care for patients. Goal. To study the pharmaceutical market of registered drugs for cardioplegia and to estimate the share of heart operations with the connection of artificial circulation performed without the use of officially registraited drugs for cardioplegia. Materials and methods. The following methods were used in the work: content analysis, statistical, marketing, graphic. The main information sources were: the State Register of Medicines; statistical indicators of surgical interventions in cardiac surgery, information on public procurement of medicines, instructions for the medical use of medicines, regulatory documents. Results. This study presents the results of a marketing analysis of the pharmaceutical market of drugs officially registered for cardioplegia. Three medicines have been registraited in Russia, which, in accordance with the instructions for use, can be used during surgical interventions in the quality of cardioplegic solutions. According to the ATC classification, all of them belong to the subgroup of the fifth level B05XA16 "Cardioplegic solutions". For the period 2018-2020. the volumes of purchases of cardioplegic solutions for the needs of medical organizations have been established and the volumes of drugs for surgical intervention in cardiac surgery during operations on the "open" heart have been determined. The comparison of morbidity rates and the estimated number of surgical interventions of the cardiac surgery service based on the data of public procurement of drugs for cardioplegia, revealed a discrepancy between the volumes of purchased cardioplegic solutions and the care provided. The data analysis shows that at least 23 thousand cardiac surgeries in Russia are performed annually without the use of registraited medicines for cardioplegia. Conclusion. When performing surgical interventions on an "open" heart with the connection of artificial blood circulation, it is necessary to use cardioplegic solutions that have an official indication in the instructions for medical use, in order to ensure the safety of patients and to perform medical interventions of appropriate quality.

COMPARATIVE CHARACTERISTICS OF EMERGENCY AND PLANNED CORONARY BYPASS GRAFTING RESULTS IN PATIENTS WITH CORONARY ARTERY DISEASE WITH LESIONS OF THE LEFT CORONARY ARTERY

The study was conducted in the period from January 2018 to December 2018 inclusive, 452 coronary artery bypass grafts were performed in the cardiac surgery department using artificial blood circulation under conditions of cold pharmacoplegia. During the study, 2 groups of patients were identified. The criteria were the timing of the surgical intervention. The first group consisted of patients who underwent elective surgery (n = 59). The second group consisted of patients undergoing emergency surgery.

Application of moderate hypothermia while performance of the aortal arch reconstruction in new-born babies in conditions of selective antegrade cerebral perfusion

Objective. To estimate a security of application of moderate hypothermia while performing the aortal arch reconstruction in new-born babies in conditions of selective antegrade cerebral perfusion. Materials and methods. In 2010-2019 yrs period in Amosov National Institute of Cardiovascular Surgery and Scientific-Practical Medical Centre of Pediatric Cardiology and Cardio-Surgery in 64 new-born babies the aortal arch reconstruction was performed in conditions of selective antegrade cerebral perfusion in moderate hypothermia. In the investigation only patients with a two-ventricle physiology, in whom further two-ventricular correction was conducted, were included. There were 48 (75%) boys and 16 (25%) girls. Median age of the patients was (1.6 ± 0.8) mo, median body mass - (3.8 ± 1.1) kg, median square of the body surface - (0.24 ± 0.04) m². Echocardiographic investigation and neurosonography were the main diagnostic procedures. Results. Hospital mortality have constituted 4.7% (3 patients died). The death cases were not connected with the brain protection procedure. Duration of artificial blood circulation period have had constituted (138.4 ± 58.8) min at average, aortal clamping - (83.1 ± 40 min), selective antegrade cerebral perfusion - (24.4 ± 8.8) min. In 10 (15,6%) patients in early postoperative period the sternum persisted open. In 4 (6.2%) patients in early postoperative period convulsions were noted, which were treated successfully medicinally. Median stay in the Department of Reanimation and Intensive Therapy have constituted (7.1 ± 4.1) days. In late follow-up period the patients were seen from 1 mo till 8.5 yrs. No one patient died. While elective neurosonography conduction the brain pathological changes were absent. The neurological complications symptoms were absent as well. Conclusion. Selective antegrade cerebral perfusion with moderate hypothermia constitutes effective and secure method of the brain protection while performance of the aortal arch reconstruction in new-born babies, using median surgical approach in conditions of artificial blood circulation.

The anemia correction in chronic diseases in perioperative period while performing prosthesis of aortal valve

Objective. To determine the impact of preoperative correction, using hydroxide of iron (III) erythropoietin, in patients, having the heart aortal failures, complicated by the chronic diseases anemia, on the postoperative anemia after doing the aortal valve prosthesis in accordance to the blood-preserving technology in the artificial blood circulation conditions. Materials and metods. The investigation was conducted in 83 patients, to whom the aortal valve prosthesis was performed with a blood-preserving technology in conditions of artificial blood circulation without application of hemo-concentrating columns and a cell-saver apparatus. All the patients were divided into three Groups in accordance to levels of hemoglobin, iron and the blood-preserving technologies applied. To the Group A 31 patients were included, in whom the initial concentration of hemoglobin, hematocrit and iron was normal. The patients were operated, using the donor’s blood components. To the Group B 37 patients were included, who were operated on without application of the donor’s blood components, using a blood-preserving technology in conditions of artificial blood circulation without application of hemo-concentrating columns and a cell-saver apparatus. In the Group C 15 patients were present, who have had initial preoperative anemia of chronic diseases with low values of hemoglobin, hematocrit and iron. Before the preoperative week a preoperative correction of anemia was conducted to them, using hydroxide of iron (III) and erythropoietin. Comparative characteristics of intraoperative application of the aortal valve prosthesis in the donor’s Group A, preoperative combined correction of anemia due to chronic illnesses - in the Group C, and of the blood-preserving technologies - in the Groups B and C are adduced. The impact of intraoperative application while performing the aortal valve prosthesis of the donor’s blood components, preoperative combined correction of the chronic diseases anemia with a blood-preserving technology in conditions of artificial blood circulation without application of hemo-concentrating columns and a cell-saver apparatus on the postoperative anemia level were investigated. Results. The data obtained witness, that in Group A with the objective to stabilize the levels of hemoglobin and hematocrit intraoperatively the donor’s blood components - (568.0 ± 93.0) ml of erythrocytic mass and (596.0 ± 48.0) ml of a fresh frozen plasm were needed, what constitutes 25% of the circulating blood volume. In Group B postoperatively after the aortal valve prosthesis in accordance to the blood-preserving technology without transfusion of the donor’s blood preparations a hemoglobin level have lowered down by 19.9% (p ˂ 0.05), hematocrit - by 17.5% (p ˂ 0.05), and a thrombocytes quantity - by 24.0% (p ˂ 0.05). Correction, performed for preoperative anemia, using hydroxide of iron (III) and erythropoietin to patients, suffering anemia due to chronic diseases in Group C, have had raised a serum iron level in 6.2 times (p ˂ 0.05), ferritin - in 5.4 times (p ˂ 0.05), and hemoglobin - by 6.7%. Performance of the aortal valve prosthesis in accordance to the blood-preserving technologies in conditions of artificial blood circulation without application of the donor’s blood components in patients of Group C have stabilized a postoperative level of the serum iron, hemoglobin and the thrombocytes quantity. Conclusion. In 18% of the patients, owing the heart aortal failures, the chronic diseases anemia is observed, caused by predominantly rheumatic inflammatory illnesses with moderate anemia and hypoferritinemia. Correction of anemia of chronic diseases, using hydroxide of iron (III) and stimulation of hematopoiesis with erythropoietin in preoperative period have raised the serum iron level in 6.2 times (p ˂ 0.05), coefficient of transferrin saturation by iron - by 41.9% (p ˂ 0.05), a ferritin level - in 5.5 times (p ˂ 0.05). For the levels of hemoglobin and hematocrit stabilization while doing the aortal valve prosthesis operation in patients of Group A the donor’s blood components - (568.0 ± 93.0) ml of erythrocytic mass and (596.0 ± 48.0) ml of the fresh frozen plasm, constituting 25% of the circulating blood volume, - were applied. In the patients of Group В after performance of the aortal valve prosthesis in accordance to the blood-preserving technology the level of hemoglobin by 17.4%, the serum iron - by 15.2% and the thrombocytes quantity - by 24.0% have lowered. Preoperative correction of anemia, using hydroxide of iron (III) and stimulation of hematopoiesis, applying erythropoietin in patients of Group C, to whom the aortal valve prosthesis was done with a blood-preserving technology in conditions of artificial blood circulation without application of hemo-concentrating columns and a cell-saver apparatus, have had lowered the postoperative anemia level by 11.7% (p ˂ 0.05).

Optical mapping of the pig heart in situ under artificial blood circulation

The emergence of optical imaging has revolutionized the investigation of cardiac electrical activity and associated disorders in various cardiac pathologies. The electrical signals of the heart and the propagation pathways are crucial for elucidating the mechanisms of various cardiac pathological conditions, including arrhythmia. The synthesis of near-infrared voltage-sensitive dyes and the voltage sensitivity of the FDA-approved dye Cardiogreen have increased the importance of optical mapping (OM) as a prospective tool in clinical practice. We aimed to develop a method for the high-spatiotemporal-resolution OM of the large animal hearts in situ using di-4-ANBDQBS and Cardiogreen under patho/physiological conditions. OM was adapted to monitor cardiac electrical behaviour in an open-chest pig heart model with physiological or artificial blood circulation. We detail the methods and display the OM data obtained using di-4-ANBDQBS and Cardiogreen. Activation time, action potential duration, repolarization time and conduction velocity maps were constructed. The technique was applied to track cardiac electrical activity during regional ischaemia and arrhythmia. Our study is the first to apply high-spatiotemporal-resolution OM in the pig heart in situ to record cardiac electrical activity qualitatively under artificial blood perfusion. The use of an FDA-approved voltage-sensitive dye and artificial blood perfusion in a swine model, which is generally accepted as a valuable pre-clinical model, demonstrates the promise of OM for clinical application.

Bloodless Operations in the Surgical Treatment of Mitral-Aortic Heart Disease in Conditions of Artificial Circulation

Traditional mitral and aortic valve replacement in conditions of artificial blood circulation (ABC) involves the use of blood products. Given various complications arising in perioperative period, the authors propose a technique for “bloodless operations” without the use of donor blood, without the use of columns, and the “sell-saver” method. From January 1, 2011 to December 31, 2018, mitral-aortic valve replacement was performed in 79 patients; in 42 of them blood products were used during surgery, and in 37 patients donor blood components were not used. The method of anaesthetic and infusion-perfusion measures for mitral-aortic valve replacement in conditions of ABC is given. The use of the blood-saving method has allowed to obtain good clinical effect without transfusion complications in perioperative period, which facilitated the use of bloodless methods for mitral-aortic valve replacement in the main group in conditions of ABC and reduce blood transfusions in perioperative period from 27.4 % to 10.3 % of the circulating blood volume (CBV), compared to the control group. In the variant of reservation of autoblood “A+B+C” and exfusion of 27.2% of the CBV, the most effective variants of the blood-saving) technology were observed during mitral-aortic valve repair in conditions of ABC.