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Siberian Journal of Clinical and Experimental Medicine

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"Siberian Journal of Clinical and Experimental Medicine" is a regular peer-reviewed scientific and practical open access journal founded in January 1922. . Issues of the journal have been published quarterly since 1996 by Cardiology Research Institute, Tomsk National Research Medical Center of the Russian Academy of Sciences. All this time the editor-in-chief has been Full Member of the Russian Academy of Sciences Rostislav S. Karpov. Since 2020, the founder of the journal has been the Tomsk National Research Medical Center.

From 2015 to the present, the journal is included in the List of peer-reviewed scientific publications of the Higher Attestation Commission (category K1), where the results of dissertations for the scientific degree of candidate and doctor of medical sciences in the following specialties should be published: 3.1.20 - Cardiology, 3.1.15 - Cardiovascular surgery, 3.1.1. X-ray endovascular surgery, 3.1.18 - Internal diseases, 3.1.21 - Pediatrics, 3.1.25 - Radiation diagnostics, 3.3.2 - Pathological anatomy, 3.3.3 - Pathological physiology, 3.3.6 - Pharmacology, clinical pharmacology, 3.3.9 - Medical informatics. The journal is presented in the National Electronic Library, in the core of the Russian Science Citation Index (RSCI), and in the «White List». Since January 2022, published articles have been indexed in the international scientometric database Scopus (Q4), and since October 2022 - in the Russian scientometric database RSCI.

Scimago:

  • Journal quartile - Q4
  • H-index of the journal = 5
  • SJR of the journal for 2024 = 0,145

The main goal of Siberian Journal of Clinical and Experimental Medicine is to inform the readership (research scientists, doctors, healthcare organizers, medical students) about the latest achievements and prospects for the development of domestic and foreign medical science. The journal is a discussion platform for the exchange of opinions and results of fundamental and applied research on a wide range of general medical issues.

Priority is given to works devoted fundamental and applied cardiology and cardiovascular surgery, as well as comorbid pathology. Along with a discussion of global trends, attention is paid to studies of regional specifics, including population trends, features of the clinical course and outcomes of diseases, the provision of specialized and high-tech medical care for cardiovascular diseases and other chronic non-infectious pathologies. We encourage publication of papers addressing the use of current information technologies in medicine and healthcare.

Current issue

Vol 41, No 3 (2026)
View or download the full issue PDF (Russian)

REVIEWS

12-18 24
Abstract

According the current concepts, chronic subclinical (low-grade) inflammation, the development of which is associated with uncontrolled activation of innate and adaptive immunity plays a fundamental role at all stages of atherosclerotic progression related to cardiovascular diseases (CVD). The significant contribution of inflammation to the development of atherosclerotic vascular lesions has drawn attention to the similarity between the immunopathogenesis mechanisms of atherosclerosis in CVD and rheumatoid arthritis, and subsequently other systemic immune-mediated rheumatic diseases (IMRDs). Among the numerous inflammatory mediators and “immune” cells involved in the immunopathogenesis of atherosclerosis in both CVD and IMIRDs, central roles are occupied by “pro-inflammatory” cytokines such as interleukin (IL)-1, IL-6, TNFα, as well as IL-17 and interferon type I, which closely interact within the “cytokine network”. As a promising therapeutic target, particular attention is drawn to IL-6, which occupies a central place in the development of many IMIDs and CVDs associated with atherosclerotic vascular lesions: coronary heart disease, acute coronary syndrome, peripheral arterial disease, ischemic stroke, heart failure, and others. Of particular importance is the fact that IL-6 hyperproduction plays a significant role in the development of a wide range of cardiometabolic diseases, including type 2 diabetes mellitus, obesity, chronic kidney disease, and metabolic dysfunction-associated fatty liver disease, associated with the development of atherosclerotic vascular lesions. Data were obtained indicating the important clinical significance of IL-6 determination for predicting the risk of premature mortality and other cardiovascular complications both in the general population of conditionally “healthy” people and in patients with various manifestations and forms of CVD. Currently, several genetically engineered biological agents - monoclonal antibodies specific for both IL-6R and IL-6 itself - have been developed. Several RCTs have recently been initiated to study the efficacy and safety of new anti-IL-6 mAbs: ziltivekimab, clazakizumab, and Pacibekitug (TOUR006) in patients with coronary artery disease, heart failure, and CKD. The article will review new data regarding the pathogenetic and clinical significance of IL-6 and the prospects for IL-6 inhibition as a component of anti-inflammatory therapy for CVD.

19-26 30
Abstract

Despite the undoubted successes achieved in the treatment of acute myocardial infarction (AMI), the problem of increasing the effectiveness of treating this disease remains relevant. Despite the undoubted successes achieved in the treatment of AMI, the problem of increasing the effectiveness of treating this disease remains relevant. With the introduction of percutaneous coronary intervention into clinical practice, myocardial reperfusion injury comes to the fore, for which drugs used to treat AMI are of little effectiveness. In our opinion, polypeptides, particularly intermedin (adrenomedullin-2), may prove to be more effective drugs for preventing myocardial reperfusion injury. Analysis of the data presented in the article indicates that this polypeptide can prevent myocardial reperfusion injury and enhance the tolerance of isolated cardiomyocytes to hypoxia/reoxygenation. It has been shown that the cardioprotective and cytoprotective effect of intermedin is associated with the activation of the RAMP2 receptor and the stimulation of several kinases. The cardioprotective effect depends on the inhibition of cardiomyocyte apoptosis and the stimulation of cardiomyocyte autophagy. The article demonstrates the expediency of conducting preclinical studies of the infarct-limiting effect of enzyme-resistant analogs of intermedin in animals with coronary occlusion and reperfusion.

Aim: To assess published data on the cardioprotective effect of intermedin. Literature search was carried out in the PubMed and eLibrary databases using the queries "intermedin", "cardioprotective effect of intermedin", "adrenomedullin-2", "myocardial ischemia reperfusion", "cardiomyocytes hypoxia reoxygenation". The search was conducted without strict time limitations, with an emphasis on experimental and review works dedicated to the cardioprotective effects of intermedin. The review includes the most relevant studies (48 sources).

27-36 32
Abstract

Post-infarction scar formation after myocardial infarction (MI) is a complex dynamic process involving stages of inflammation, proliferation, and scar maturation. Reparative processes in MI mainly occur during the proliferation stage, including angiogenesis, fibrogenesis, and cardiomyogenesis, the latter characterized by insufficient effectiveness for complete myocardial recovery after irreversible damage. The review summarizes current data on the molecular mechanisms of the reparative response in MI, which involves both resident myocardial cells and leukocytes, stem and progenitor cells recruited from the bloodstream. Growth factors, cytokines, and biologically active substances play an important role in the regulation of cellular processes occurring at the proliferation stage after MI. The local concentration of growth factors in the damaged myocardium, as well as the dynamics of their formation, determine the outcomes of ischemic myocardial damage associated with postinfarct remodeling and the likelihood of developing chronic heart failure. This allows us to consider growth factors, their receptors, and cellular signaling pathways as promising therapeutic targets to prevent adverse outcomes after MI.

37-44 33
Abstract

In clinical practice, the diagnosis of arterial hypertension (AH) and the monitoring of antihypertensive therapy are predominantly based on office blood pressure (BP) measurements in the seated position. This approach remains the standard due to its accessibility and simplicity. However, the isolated use of office measurements fails to reflect the phenotypic diversity of AH and is associated with an underestimation of cardiovascular risk. The present literature review assesses the relationship between blood pressure (BP) elevation patterns and cardiac pathology, as well as cardiovascular events, in patients with AH. The review was performed in accordance with the general principles of writing analytical reviews. A search for relevant publications was conducted in the electronic databases PubMed/MEDLINE, Scopus, Web of Science, and Google Scholar. The search covered a 20-year period (from 2005 to 2025). When necessary, earlier works of fundamental importance were also analyzed. Search queries were constructed using combinations of keywords and MeSH terms, including: “arterial hypertension”, “phenotypes of hypertension”, “ambulatory blood pressure monitoring”, “ambulatory blood pressure profiles”, “isolated nocturnal hypertension”, “blood pressure in the sitting and lying position”, and “cardiovascular complications”. The search strategies were adapted to the requirements of each specific database. Considerable attention is given to results demonstrating the unfavorable prognostic value and insufficient reduction in blood pressure levels at night, as measured by 24-hour blood pressure monitoring. Limitations in the informativeness of this method, primarily due to the variability of study results, are also noted. It is convincingly demonstrated that insufficient reduction in blood pressure levels and their increase in the supine position, compared to the sitting position, correlates with 24-hour blood pressure profiles using the night picker method. Furthermore, this method, with its high information content and reproducible results, is more readily available for use in clinical practice. This allows us to recommend it for widespread use to identify patients with hypertension and a prognostically unfavorable type of disease with an increased risk of cardiovascular complications.

45-52 31
Abstract

Introduction. Myocardial bridges (MBs) are a congenital anomaly of the coronary arteries (CAs) in which a vascular segment runs intramurally. The widespread implementation of multislice computed tomography angiography (MSCT-CAG) has led to an increase in the detection of MBs in pediatric practice; however, the absence of uniform diagnostic criteria and management protocols creates clinical uncertainty.

Aim: To systematize current data on the prevalence, pathophysiology, clinical significance, diagnosis, and treatment of myocardial bridges in children.

Methods. A literature review was conducted using PubMed and eLibrary databases for the period 1997–2025 with keywords: myocardial bridging, children, coronary arteries, myocardial ischemia, MSCT coronary angiography.

Results. The prevalence of MBs varies from 0.5–16% with coronary angiography to 22.5–35% with MSCT. The most common localization is the left anterior descending artery and its diagonal branches. The pathophysiological basis of ischemia is dynamic systolic compression, exacerbated by tachycardia. Clinical manifestations range from asymptomatic progression to life-threatening arrhythmias and sudden death. The diagnostic algorithm includes anatomical imaging (MSCT-CAG) and functional assessment (stress tests, intravascular ultrasound (IVUS)). First-line therapy consists of β-blockers; surgical myotomy is indicated in refractory cases.

Conclusion. MBs in children require a differentiated approach that includes anatomical imaging followed by functional assessment. Risk stratification strategies and evidence-based clinical guidelines derived from prospective studies in the pediatric population are needed.

53-63 24
Abstract

Introduction. Coarctation of the aorta (CoA) remains one of the most common congenital heart defects, associated with a high incidence of cardiovascular complications even after successful correction. Despite advances in both endovascular and surgical repair techniques, there is no unified approach to selecting the optimal treatment strategy, and the available data on long-term postoperative outcomes require systematic synthesis.

Aim: To analyze current data on the surgical and endovascular treatment of CoA in patients of different age groups, to characterize the anatomical features of the congenital defect, the technical aspects of interventions, immediate and long-term treatment outcomes, as well as to assess the incidence of complications and reinterventions.

Material and Methods. A literature search was performed using the electronic databases eLibrary.ru and PubMed. The study included articles published between 2014 and 2026. A total of 1,331 publications on aortic coarctation were screened. Ultimately, 52 studies were included in the final review.

Results. Analysis of the included publications showed that surgical correction remains the “gold standard” in neonates and young children, whereas endovascular repair is preferred in adolescents and adults. In the long term, neither of these strategies completely eliminates risks: the potential for arterial hypertension, recoarctation, aneurysm formation, and the need for repeat interventions persists.

Conclusion. The choice of treatment strategy for aortic coarctation should be individualized, taking into account the patient's age, the anatomy of the narrowing, and the technical capabilities of the medical center. However, all patients, regardless of the correction method, require lifelong dynamic follow-up with regular blood pressure monitoring and aortic imaging for timely detection and management of long-term postoperative complications.

CLINICAL STUDIES

64-73 30
Abstract

Introduction. Body structure abnormalities such as sarcopenia, sarcopenic obesity, and cachexia can play a key role in the development and progression of chronic heart failure (CHF). However, diagnosis of these conditions is challenging due to the lack of unified approaches to their definition. Previously proposed algorithms for identifying cachexia and sarcopenia in elderly patients are difficult to apply in clinical practice. Therefore, noninvasive body composition assessment in elderly patients with CHF, such as bioelectrical impedance analysis (BIA), is becoming relevant.

Aim: To determine the most frequent pathological phenotypes of body composition in elderly patients with CHF and establish their relationship with adverse disease outcomes.

Material and Methods. The prospective observational study included 250 patients (median age 83.0 [77.0-86.0] years) consecutively hospitalized in a multidisciplinary hospital for CHF decompensated. To assess body composition, a bioinformatics analyzer (BIA) (ABC-01 Medass analyzer, Russia) was performed on days 5-7 of hospitalization. According to the results, patients were divided into five body composition phenotypes: normal, obese, sarcopenic obesity (according to ESPEN/EASO 2022 criteria), sarcopenia (according to EWGSOP2 criteria), and cachexia (according to Ballyuzek MF, 2015 criteria). To study the prognostic significance of body composition abnormalities, a composite endpoint was assessed, including all-cause mortality and recurrent hospitalizations for CHF within 12 months.

Results. When analyzing body composition phenotypes according to BIA in elderly patients with CHF, the most common phenotype was obesity (48.0%, n = 120), less common were sarcopenic obesity (24.0%, n = 60), sarcopenia (6.0%, n = 15), and cachexia (2.0%, n = 5). Depending on body composition phenotypes, patients did not differ in left ventricular ejection fraction; a predominantly preserved ejection fraction was observed in all groups. Patients with cachexia, sarcopenia, and sarcopenic obesity were characterized by lower exercise tolerance, NYHA functional class III-IV, and a more severe stage of circulatory failure. The presence of sarcopenic obesity or sarcopenia increases the risk of the combined primary endpoint by 2.3 times (OR 2.3; 95% CI 1.2-4.4, p < 0.05) and in-hospital mortality by 2.9 times (OR 2.9; 95% CI 1.4-6.4, p < 0.05).

Conclusion. Muscle mass has a protective effect in elderly patients with CHF, whereas sarcopenic obesity and sarcopenia are associated with worse outcomes. Bioimpedance analysis of body composition is relatively simple and accurate in this patient cohort and allows for the detection of dual pathology in patients with CHF: hyperhydration typical of CHF decompensation and associated signs of progressive sarcopenia and cellular dysfunction.

74-80 30
Abstract

Current phenotypic classification of hyperuricemia (HU) and gout is based on the presence/absence of monosodium urate (MSU) crystals, clinical signs of gout, and tophi in individuals with elevated uric acid (UA) levels. It is hypothesized that the severity of subclinical inflammation may differ for HU and gout phenotypes.

Aim: To test the hypothesis of increasing systemic inflammation intensity with HU progresses in patients within the proposed phenotypic classification.

Material and Methods. 220 patients with HU (UA > 360 μmol/L) over 18 years of age were examined and divided into the following phenotypes: asymptomatic HU (AHU); AHU with MSU crystals (verified by ultrasound or synovial fluid analysis) (AHU+crystals); intermittent gout (G); tophaceous gout (G+tophi). Comparative characteristics of the groups included an assessment of the frequency of comorbidities, metabolic disorders, and the main laboratory parameters.

Results. According to phenotyping results, the group of patients with AHU consisted of 40 people (18.2%), AHU+crystals – 26 (11.8%), G – 111 (50.5%), G+tophi – 43 (19.5%). The age in the groups was comparable (p = 0.5). An increase in the incidence of arterial hypertension and nephrolithiasis was revealed in the series AHU – AHU+crystals – G – G+tophi (p = 0.0006 and p = 0.00006, respectively). There was a statistically significant sequential increase in the median value of IL-6 in the groups from AHU to G+tophi (p = 0.0001). Also, in patients with AHU without MSU crystals, the average serum level of IL-18 was lower than that in the G+tophi group (p = 0.01). The level of highly sensitive C-reactive protein (hsCRP) was statistically significantly different in patients with AHU compared to patients with G and G+ tophi (p = 0.04 in both cases). Correlation analysis revealed a weak positive association between UA and IL-6 levels (r = 0.14, p < 0.05) and UA and hsCRP levels (r = 0.26, p < 0.05) in the general group (n = 220). A weak correlation between IL-6 and UA levels was also observed within each group (p < 0.05 in all cases). A moderate positive correlation was also found between UA and IL-8 levels (r = 0.36, p < 0.05) in patients in the AHU group (n = 40).

Conclusions. The severity of chronic inflammation in HU is associated with the level of serum UA in the blood and the presence of MSU crystals, and increases during the progression from AHU to chronic tophaceous gout.

81-89 27
Abstract

Introduction. Fabry disease is an X-linked lysosomal storage disorder with multisystem involvement, the clinical manifestations and severity of which differ significantly between males and females. The diversity of early symptoms and target organ damage often leads to delayed diagnosis, while timely diagnosis is essential for early initiation of specific therapy.

Aim: To study the clinical features of Fabry disease in males and females in the Russian population over the period from 2015 to 2026 for early diagnosis of the disease.

Material and Methods. A retrospective cohort study with a comparative analysis of clinical manifestations of Fabry disease in adult males and females was conducted. The cohort study, covering the period from 2015 to 2026, included 259 adult patients with Fabry disease confirmed by molecular genetic testing (150 males and 109 females; median age 45.5 years). To assess target organ damage, daily albuminuria, serum creatinine levels, 24-hour Holter ECG monitoring, echocardiography, cardiac and brain magnetic resonance imaging (MRI) were performed. Clinical manifestations were assessed in the overall cohort and separately in males and females.

Results. The majority of patients had typical early manifestations of Fabry disease from childhood or adolescence, including neuropathic pain in the hands and feet (67.6%), angiokeratomas (33.6%), cornea verticillata (58.3%), hypohidrosis (49.4%), and/or gastrointestinal symptoms (19.3%). The target-organ involvement, that is, kidney, heart, and brain disease, was detected in 80.3%, 61.0%, and 48.3% of patients, respectively. Despite the relatively young age of the examined patients, many presented various disease outcomes, such as dailysis-dependent chronic renal failure (20.1%), stroke (18.1%), including recurrent stroke, and/or severe left ventricular hypertrophy (LVH) (21.6%) accompanied by arrhythmias and/or chronic heart failure. Mortality during follow-up was 12.7%. Male patients had a more severe clinical course of Fabry disease and developed adverse outcomes at younger age.

Conclusion. Fabry disease should be suspected in adults patients with nephropathy or left ventricular hypertrophy of unknown origin and/or stroke at a young age, particularly when these findings are accompanied by typical early manifestations of the disease.

90-102 35
Abstract

Background. The role of revascularization in patients with severe ischemic left ventricular (LV) dysfunction remains a matter of debate, particularly with regard to patient selection and prognostic stratification. Conventional assessment of myocardial viability does not always reliably predict clinical outcomes. The prognostic value of quantitative assessment of biventricular reserve during dobutamine stress echocardiography (DSE) remains insufficiently studied.

Aim: To evaluate the prognostic value of conventional and additional DSE parameters for predicting 3-year all-cause mortality in patients with coronary artery disease (CAD) and severe LV systolic dysfunction referred for treatment strategy selection.

Methods. This single-center retrospective observational study included 75 patients with ischemic LV systolic dysfunction and available 3-year vital status data: mean age 60,6 ± 7,1 years, 70 (93.3%) were men, LV end-systolic volume index 77,0 (69,6; 90,7) mL/m², and LV ejection fraction (LVEF) 30,1 ± 5,6%. All patients underwent DSE with assessment of conventional markers of myocardial viability and LV contractile reserve, including LVEF and regional wall motion abnormalities (RWMA), as well as global longitudinal strain (GLS), LV pump function, and right ventricular (RV) longitudinal systolic function assessed by tricuspid annular plane systolic excursion (TAPSE) and peak systolic velocity of the basal segment of the RV free wall (RV S′). Surgical revascularization was performed in 62 (82,7%) patients. The primary endpoint was all-cause mortality within 3 years. The prognostic value of the parameters was assessed using Cox regression and Kaplan–Meier analysis.

Results. Three-year survival was 70,7%. Myocardial viability according to conventional criteria was identified in 51 (68,0%) patients; however, the presence of viable myocardium, type of stress response, increase in LVEF, and change in wall motion score index were not significantly associated with 3-year survival. Patients with adverse outcomes had lower stress-induced LVEF, LV pump function parameters (LVOT VTI), worse GLS, and more pronounced RV dysfunction at rest and during DSE. In univariable Cox models, significant associations with 3-year all-cause mortality were found for stress-induced LVEF, GLS, LVOT VTI, LV stroke index, TAPSE, and RV S′. In limited two-variable models adjusted for LV functional parameters, the maximal stress-induced RV S′ remained significantly associated with 3-year all-cause mortality. Kaplan–Meier analysis demonstrated significant separation of survival curves according to RV S′, TAPSE, and LVOT VTI.

Conclusion. In patients with CAD and severe LV systolic dysfunction, conventional markers of myocardial viability and LV contractile reserve during DSE had limited prognostic value. A stronger association with 3-year all-cause mortality was observed for parameters of RV systolic function, particularly stress-induced RV S′, and LV pump function.

103-113 25
Abstract

Introduction. Aortic valve replacement (AVR) remains the only effective treatment method for severe symptomatic aortic valve disease; however, the choice of the optimal prosthesis for young patients continues to be debated. Mechanical prostheses, despite their durability, require lifelong anticoagulation, increasing the risk of complications and reducing quality of life, while the Ross procedure offers the prospect of long-term survival comparable to that of the general population.

Aim: To compare the immediate and long-term outcomes of the Ross procedure and mechanical aortic valve replacemnet in patients aged 50 years and younger.

Material and Methods. A retrospective analysis of 694 patients who underwent the Ross procedure or mechanical AVR at the Federal Center for Cardiovascular Surgery (Astrakhan, Russia) between 2009 and 2019 was performed. After applying inclusion criteria (age ≥ 18 years, prosthetic aortic valve replacement with a mechanical prosthesis or pulmonary autograft) and exclusion criteria (concomitant coronary artery bypass grafting (CABG), double-valve replacement, left ventricular ejection fraction ≤ 30%), 277 patients were selected and divided into two groups: Ross procedure (n = 178) and mechanical AVR (n = 99). The propensity score matching (PSM) method was used, forming two balanced groups of 66 patients each. Hospital mortality, complications, survival, freedom from reoperation, stroke, and combined endpoints were evaluated (mortality+stroke).

Results. The median age in both groups was 44 years (p = 0.993), with no significant differences in sex (p = 0.324) or functional class of heart failure (p = 0.598). Operative time, cardiopulmonary bypass time, and myocardial ischemia time were longer in the Ross group (p < 0.001). Postoperative complications and hospital mortality did not differ, except for a higher rate of fresh frozen plasma transfusion in the Ross group (43.9% vs. 25.8%, p = 0.02). Peak and mean pressure gradients across the aortic valve were lower in the Ross group (p < 0.001). One-year, three-year, five-year, and ten-year survival, freedom from cardiovascular mortality, and freedom from reoperation did not differ between groups (p > 0.05). After PSM, differences in freedom from stroke and combined endpoints (mortality and stroke) were also eliminated (p = 0.134 and p = 0.238, respectively).

Conclusion. The Ross procedure and mechanical AVR demonstrate comparable short- and long-term outcomes in patients aged 50 years and younger. The Ross procedure is associated with better hemodynamic performance but requires longer operative times. Both methods can be effective treatment strategies, and the choice should be based on individual patient characteristics and surgical center expertise.

114-121 22
Abstract

Introduction. Modern advances in bicuspid aortic valve (BAV) reconstructive surgery, despite their significance, have significant limitations. Neocuspidization using autologous pericardium (Ozaki technique) is considered as an alternative approach to correcting BAV pathology. Up to 50% of patients with BAV have associated aortopathy, which can involve the proximal aorta and mid-portion of the ascending aorta. In this article, we present a comparative analysis of the results of Ozaki neocuspidation and mechanical prosthesis implantation in patients with bicuspid aortic valves and concomitant ascending aortic valve replacement (AVR).

Aim: To compare the immediate outcomes of Ozaki neocuspidization and mechanical prosthesis implantation in patients with bicuspid aortic valves and concomitant ascending aortic valve replacement.

Material and Methods. The study included 137 patients who underwent surgery at the clinic between January 2017 and January 2025. A retrospective observational comparison of surgical outcomes of two groups was performed: Group 1 – the study group, consisting of 63 patients who underwent neocuspidization using the Ozaki technique combined with ascending aortic replacement; Group 2 – the control group, consisting of 74 participants who underwent AVR with a mechanical prosthesis and ascending aortic replacement.

Results. A statistically significant difference was observed based on postoperative ultrasound data: the effective orifice area in Group 1 was 4.7 ± 1.1 versus 2.3 ± 0.4 in Group 2 (p = 0.04). The mean gradient was 4.5 ± 2.1 in Group 1 and 10.6 ± 2.2 in Group 2 (p = 0.04). The maximum gradient was 9.5 ± 2.8 and 17.6 ± 2.9 in Groups 1 and 2, respectively (p = 0.04). In-hospital mortality and the incidence of postoperative complications did not differ significantly between the two groups.

Conclusion. No statistically significant differences were observed in in-hospital comparisons of intraoperative characteristics and early postoperative complications. However, significantly better hemodynamic parameters were observed in the study group.

122-132 305
Abstract

Background. Amiodarone remains one of the most effective antiarrhythmic drugs; however, its use is associated with a risk of amiodarone-induced thyroid dysfunction, including thyrotoxicosis and hypothyroidism. Thyroid dysfunction may worsen the course of cardiovascular disease and affect in-hospital prognosis. Despite the availability of clinical guidelines, data on the real-world incidence of amiodarone-induced thyroid dysfunction and its association with in-hospital outcomes remain limited.

Aim: To evaluate the incidence of amiodarone-induced thyroid dysfunction, identify factors related to its presence, assess the relationship between thyroid dysfunction and cardiovascular complications and hospital mortality.

Material and Methods. A retrospective analysis was performed in 340 patients receiving amiodarone therapy during hospitalization. Age, sex, primary cardiac diagnosis, left ventricular ejection fraction, amiodarone dose, duration of therapy, thyroid status parameters, and in-hospital outcomes were evaluated. The presence of amiodarone-induced thyroid dysfunction was determined on the basis of a clinical diagnosis documented in the medical records. Group comparisons of quantitative and categorical variables, an additional Welch t-test, contingency table analysis, and binomial logistic regression were used.

Results. Amiodarone-induced thyroidopathy was detected in 40 out of 340 patients (11.8%). Age was associated with a higher odds ratio for thyroid disease (OR = 1.12; 95% CI for OR 1.07–1.17; p < 0.001; approximately a threefold increase in the odds of developing thyroid disease over 10 years). A maintenance dose of amiodarone doubled the odds of a thyroid disorder diagnosis (OR = 1.01 per 1 mg; 95% CI for OR 1.007–1.014; p = 0.031); the dose of amiodarone received during hospitalization was not statistically significant. Left ventricular ejection fraction showed no association with the development of thyroidopathy. The presence of amiodarone-induced thyroidopathy was associated with a threefold increase in the odds of cardiac complications (OR = 3.47; 95% CI 1.61–7.47; p = 0.001). The association between thyroid dysfunction and in-hospital mortality was not assessed due to the low incidence of the event (1.18%, n = 4).

Conclusion. Amiodarone-induced thyroid dysfunction develops in approximately one in nine patients receiving amiodarone therapy and is related to an adverse in-hospital course. Older age and a higher maintenance dose of the drug were related to a higher probability of detecting amiodarone-induced thyroid dysfunction. Differences in the dynamics of hormonal normalization confirm the heterogeneity of the pathogenesis of thyroidopathy, given that its development is not associated with systolic myocardial dysfunction. These data may serve as a basis for revising the management guidelines for patients taking amiodarone. The study results can be used to personalize thyroid function monitoring in older patients and when higher maintenance doses of amiodarone are used.

133-140 20
Abstract

The transradial approach is the gold standard for coronary interventions, however, radial artery occlusion (RAO) remains a frequent complication limiting the possibility of repeated use of the vessel. Despite all existing methods for RAO prevention, they are all aimed at influencing the radial artery (RA) during or immediately after the procedure.

Aim: To evaluate the efficacy and safety of RAO prevention with Rivaroxaban 2.5 mg twice daily for 3 months in patients after coronary interventions performed via the transradial approach (TRA).

Material and Methods. A single-center randomized controlled trial was conducted (n = 300). Patients were randomly assigned (1:1) to one of two groups: those receiving Rivaroxaban 2.5 mg twice daily for 3 months after transradial endovascular coronary intervention (Rivaroxaban group – Group I), and those receiving standard treatment (control group – Group II). The primary endpoint was the incidence of RAO at day 7 after puncture, as well as at 1 and 3 months; assessed by ultrasound Doppler control. Secondary endpoints were hemorrhagic complications according to the BARC classification.

Results. The administration of Rivaroxaban led to a significant reduction in RAO incidence at all follow-up time points: day 7 – 0.7% vs. 12.7%, p < 0.001; OR = 0.046 (95% CI: 0.006–0.35); 1 month – 3.3% vs. 14.7%, p < 0.001; OR = 0.20 (95% CI: 0.07–0.54); 3 months – 4.0% vs. 13.3%, p = 0.004; OR = 0.27 (95% CI: 0.10–0.72). No cases of severe bleeding BARC type 3–5 were observed in either group. The number of minor bleeding events (BARC 1) in the entire sample was 1.3%, with no statistically significant difference between the groups: 1.0% vs. 0.33%, p = 0.624; OR = 3.04 (95% CI: 0.31–29.6).

Conclusions. The administration of Rivaroxaban 2.5 mg twice daily for 3 months can be considered an effective and safe method for RAO prevention in patients after elective coronary interventions performed via the transradial approach.

141-147 24
Abstract

Background. Hypertension is a leading global cause of cardiovascular morbidity and mortality. Uric acid (UA) is implicated in oxidative stress, endothelial dysfunction, and hypertensive pathophysiology. Salivary UA offers a non-invasive, cost-effective alternative to serum analysis.

Aim: To compare salivary UA levels in hypertensive adults against normotensive controls and evaluate its diagnostic utility.

Material and Methods. This prospective case-control study enrolled 60 adult hypertensive patients and 60 age- and sex-matched normotensive controls. Non-stimulated whole saliva (NWS) and stimulated whole saliva (SWS) were collected following a standardised protocol. Salivary UA concentrations were measured spectrophotometrically using a commercial QuantiChrom™ Uric Acid Assay Kit. Serum UA, total antioxidant capacity (TAC), and salivary flow rates were also assessed. Pearson correlation coefficients and receiver operating characteristic (ROC) analysis were applied for statistical evaluation.

Results. SWS UA was significantly higher in the hypertensive group (18.62 ± 3.27 µg/mg protein) versus controls (6.14 ± 1.92 µg/mg protein; p < 0.001). NWS UA was similarly elevated. Salivary UA in SWS correlated positively with systolic blood pressure (r = 0.79, p < 0.001), diastolic blood pressure (r = 0.81, p < 0.001), and serum UA (r = 0.84, p < 0.001). ROC analysis showed SWS UA had an AUC of 0.97 with sensitivity of 92% and specificity of 93% in differentiating hypertensive from normotensive individuals. Stimulated salivary flow was significantly lower in the hypertensive group.

Conclusion. Salivary UA, particularly measured in stimulated saliva, is markedly elevated in hypertensive patients and demonstrates strong diagnostic performance. It represents a promising non-invasive biomarker for hypertension screening and monitoring, warranting validation in larger multicentre studies.

148-154 15
Abstract

Until recently, the only transcatheter synthetic aortic prostheses available on the Russian market were those with transapical or transaortic delivery systems. A synthetic prosthesis with a novel transfemoral delivery system has been developed in our country; however, the literature contains no data on the results of its use.

Aim: To assess the incidence of in-hospital complications in the early postoperative period following transcatheter aortic valve replacement (TAVR) with the MedInzh prosthesis in patients with degenerative aortic valve stenosis, based on multislice computed tomography (panaortography) data (MSCT), and to identify their potential anatomical predictors.

Material and methods. This clinical trial is a prospective, single-center pilot study included patients with confirmed severe aortic stenosis: effective aortic valve orifice area of ≤ 1.0 cm²; mean transvalvular gradient ≥ 40 mmHg. All patients underwent transfemoral valve replacement for correction of severe degenerative aortic stenosis using the synthetic MedInzh prosthesis. All procedures were performed between 2023 and 2025.

Results. A total of 30 patients at moderate and high surgical risk were enrolled; median age was 75 (68.5; 77.5) years; 27% were male. The incidence of in-hospital complications was 27% (acute cerebrovascular accident 7%; ventricular arrhythmias 7%; acute common iliac artery thrombosis 7%; acute myocardial ischemia 3%; lymphocele 3%). The odds of complications after TAVR increased when the minimal diameter of the common iliac artery on the access side was ≤ 10.5 mm (OR = 19.2; 95% CI: 1.844–199.9); with the longitudinal diameter of the external iliac artery was ≤ 7.75 mm (OR = 25.5; 95% CI: 2.5–276); and with a transverse diameter was ≤ 8.2 mm (OR = 8; 95% CI: 1.2–55).

Conclusions. Among intermediate- and high-risk patients with severe symptomatic aortic stenosis undergoing transfemoral aortic valve replacement with the MedInzh prosthesis, the rate of in-hospital complications was 27%, with vascular complications accounting for 7%. MSCT panaortography results suggest that the diameter of the common iliac arteries, the minimal diameter of the common iliac artery, and the longitudinal and transverse diameters of the external iliac arteries on the access side are potential anatomical predictors associated with the development of vascular complications after TAVR.

155-163 28
Abstract

Approximately 20% of patients develop various complications within the first year after myocardial infarction, including coronary artery restenosis, ischemic stroke, fatal arrhythmias, heart failure and/or cardiac death. Components of metabolic syndrome are recognized as risk factors for cardiovascular disease, but their role is more significant in the development of primary myocardial infarction. There is a need to search for biomarkers to predict the unfavorable clinical outcomes of acute coronary syndrome (ACS). The study of vitamin D metabolism, fibrinolysis system proteins and levels of cardiac-specific microRNAs 21, 29, and 143 appears to be promising as such predictors.

Aim: To identify the association of adverse outcomes within one year after myocardial infarction and vitamin D metabolism parameters, levels of fibrinolytic system components, and cardiac-specific microRNAs in patients with metabolic syndrome.

Material and Methods. The study included 152 patients initially hospitalized in a vascular center with a preliminary diagnosis of “ST-segment elevation ACS”. All patients underwent routine examination according to the standards for the management of patients with acute coronary syndrome. Adverse clinical outcomes were defined as recurrent ACS, arrhythmia and conduction disorders, left ventricular aneurysm, ischemic stroke, and death within 3 months after ACS. Depending on the presence of metabolic syndrome (MS), all patients were divided into two groups: group 1 – 94 patients with verified signs of MS; group 2 – 58 patients without MS. All patients underwent testing for vitamin D concentration; genetic variants of vitamin D receptor and vitamin D-binding protein polymorphisms; concentrations of urokinase and soluble urokinase receptor; and microRNAs-21, -29, and -143.

Results. Compared to group 2, group 1 had higher average levels of urokinase, soluble urokinase receptor, microRNA-29 and microRNA-143; lower average levels of 25(OH)D, and a higher frequency of the VDBP rs4588 C/A genotype; these differences were statistically significant. A correlation was found between adverse clinical outcomes in group 1 and microRNA-29 (r = 0.472, p < 0.0001), LDL levels (r = 0.234, p = 0.001), soluble urokinase receptor (r = 0.542, p < 0.0001), the presence of diabetes mellitus (p < 0.0001), and vitamin D-binding protein VDBP rs4588 polymorphism with genotype AA (p = 0.0011).

Conclusion. Potential biomarkers for the development of adverse clinical outcomes of acute coronary syndrome in patients with metabolic disorders were: the presence of diabetes mellitus, microRNA-29 levels and soluble urokinase receptor levels.

164-172 30
Abstract

Global trends in reducing cardiovascular mortality in the second decade of the 21st century, demonstrated by a number of studies, highlight another phenomenon – the increase in the prevalence of psychosocial risk factors for cardiovascular diseases, and in particular, such a factor of chronic social stress as stress in the family. The obtained relationships between the prevalence of stress in the family with the mobile nature of work and behavioral characteristics, depending on the length of service in the oil and gas industry of the Arctic territories of Russia, seem necessary to use for the formation of a comprehensive program for the primary prevention of cardiovascular diseases.

Aim: To determine of associations between the prevalence of stress in the family and some parameters of attitudes towards smoking, nutrition, and physical activity depending on length of service among those working on expeditionary shifts in the Arctic.

Material and Methods. The study subjects were men aged 25–54 years working in the expeditionary shift mode at the industrial enterprise EURACOR, the sample consisted of 750 people, the response rate was 82.4%. The WHO MONICA-MOPSY questionnaire was used to determine stress in the family, attitudes towards smoking, nutrition, and physical activity.

Results. Regardless of length of service on an expeditionary watch, in the presence of family stress, an increase in the intensity of tobacco smoking was found among men aged 25–54 years; with an increase in work experience up to nine years, a tendency towards a decrease in the proportion of people who quit smoking was determined; with experience of ten years or more, a decrease in attempts to quit smoking was determined. With 10 years or more of experience in expeditionary watch mode and the presence of stress in the family, tendencies towards diet violations and unsuccessful attempts to adhere to it were identified. With more than three years of experience, among men 25–54 years old with stress in the family, a decrease in physical activity and a decrease in assessment of their physical activity compared with peers were found.

Conclusion. An analysis of the definition of stress in the family, its associations with the attitude of shift workers to smoking, nutrition and physical activity depending on the length of service of the expedition shift, can be a fundamental element of the scientific position in the formation of a program for the primary prevention of cardiovascular diseases in the Arctic.

EXPERIMENTAL STUDIES

173-181 21
Abstract

Background. Efficient implementation of endothelial-protective and anti-atherosclerotic interventions in hyperlipidemic (including ApoE–/– mice requires the identification of the optimal experimental parameters (sex and age) for the stable detection of aortic atherosclerosis as well as lipid and calcium deposition in the aortic valve.

Aim: To analyze gender and age-related patterns of lipid deposition in the aorta and lipid and calcific lesions of the aortic valve in ApoE–/– mice.

Material and Methods. The study included 100 ApoE–/– mice: 20 mice (10 males and 10 females) at each of the following ages: 1, 3, 6, 12, and 18 months. Aortas and left ventricle segments with the aortic valve (AV) were used as for histopathological analysis.

Results. Lipid deposition in the aorta of ApoE–/– mice was first detected at 6 months of age, whilst the median proportion of lipid-positive aortic area was 0.90% (IQR: 0.00–1.44%) in males and 1.47% (IQR: 0.76–1.89%, p = 0.35) in females. By 12 months of age, median proportion of lipid-positive aortic area in the aorta increased to 29.80% (IQR: 19.22–33.42%) in males and 16.41% (IQR: 13.18–19.50%, p = 0.001) in females. Lipid deposition in the AV leaflets was detected starting from 1 month of age (median lipid-positive area: 0.76% [IQR: 0.14–1.54%] in males and 1.07% [IQR: 0.90–1.69%], p = 0.27 in females) and progressively increased (at 3 months: 2.95% [IQR: 1.11–7.64%] in males vs. 7.15% [IQR: 4.19–9.48%], p = 0.14 in females; at 6 months: 8.04% [IQR: 5.68–13.89%] in males vs. 5.70% [IQR: 4.63–10.21%], p = 0.31 in females; at 12 months: 15.58% [IQR: 12.27–21.44%] in males vs. 8.95% [IQR: 7.52–10.02%], p = 0.002 in females). Up to 6 months, only sporadic calcification foci were observed in ApoE–/– mice. At 12 months, the median proportion of calcified AV leaflet area was 4.87% (IQR: 3.27–9.19%) in males and 5.76% (IQR: 2.96–9.26%, p = 0.91) in females. The increase in both the area and intensity of Alizarin Red staining correlated with the extent of lipid deposition in the aorta (r = 0.736 and r = 0.708, respectively).

Conclusion. Aortic lipid lesions in ApoE–/– mice are consistently detectable after 6 months of age and stabilizes by 12 months. Lipid lesions in the AV leaflets of ApoE–/– mice of both sexes is detectable as early as 1–3 months, progresses until 6 months, and stabilizes by 12 months. At 12 months, lipid lesions of both the aorta and AV are more pronounced in males than in females. Mineralization foci of AV leaflets begin to develop at approximately 6 months of age, with stabilization of calcification by 12 months. The strong correlation between lipid deposition in the aorta and calcium deposition in the AV leaflets suggests a pathogenetic parallelism of these processes within the circulatory system of ApoE–/– mice. These findings indicate that ApoE–/– mice can be optimally withdrawn from experiments between 9 and 12 months of age.

182-188 37
Abstract

Introduction. Traumatic brain injury (TBI) remains a leading cause of mortality and disability among young and working-age individuals. Key mechanisms of secondary brain damage include glutamate excitotoxicity, oxidative stress, mitochondrial dysfunction, neuroinflammation, and dysregulation of matrix metalloproteinases. The comparative efficacy of neuroprotective agents with different mechanisms of action in TBI requires investigation due to the insufficient coverage of this problem.

Aim: To conduct a comparative experimental evaluation of the neuroprotective effects of memantine, choline alfoscerate, citicoline, and ethylmethylhydroxypyridine succinate in a rat model of contusion traumatic brain injury based on parameters of oxidative stress, neuroinflammation, excitotoxicity, MMP-2 activity, and energy metabolism.

Material and Methods. The study was performed on 60 male Wistar rats divided into 6 groups of 10 animals each: sham-operated (SO), negative control (NC), as well as groups receiving memantine, choline alfoscerate, citicoline, or EMHPS (ethylmethylhydroxypyridine succinate). Contusion traumatic brain injury (cTBI) was induced under anesthesia by dropping a 50 g weight from a height of 2 cm. The compounds were administered orally from days 2 to 8 post-injury. Brain homogenates and mitochondrial fractions were analyzed for TNFα, glutamate, MMP-2, MitoH2O2, as well as aerobic and anaerobic metabolism.

Results. cTBI caused an increase in TNFα by 261.8% (p < 0.05), MitoH2O2 by 92.3%, glutamate by 73.2%, MMP-2 by 81.8%, and anaerobic metabolism by 146.7%, as well as a decrease in aerobic metabolism by 56.1% (p < 0.05). The most pronounced restoration of cognitive function (Y-maze) was provided by EMHPS (+103% relative to NC, p < 0.05), which also maximally reduced MitoH2O2 (by 42.3%) and glutamate (by 26%), and increased aerobic metabolism (by 50%). Memantine reduced glutamate levels (by 31.3%; p < 0.05) and MMP-2 (by 25.6%; p < 0.05), but had no effect on TNFα or MitoH2O2 (p > 0.05). Choline alfoscerate and citicoline showed partial but divergent effects.

Conclusion. Ethylmethylhydroxypyridine succinate (EMHPS) demonstrated the most balanced neuroprotective effect in cTBI, making it promising for further preclinical and clinical studies. Investigation of combination therapy and longer observation periods is warranted.

CLINICAL CASES

189-196 128
Abstract

Acute respiratory distress syndrome (ARDS) remains one of the most common and severe complications in patients undergoing thoracic aortic reconstructive surgery under conditions of cardiopulmonary bypass, hypothermia, and circulatory arrest. The development of ARDS requires prolonged respiratory support, prolongs the length of stay in the intensive care unit, and significantly increases the risk of pneumonia, sepsis, and multiple organ failure. We present a clinical case of successful early prophylactic administration of exogenous surfactant (Surfactant-BL) to a 62-year-old patient with an aortic arch aneurysm and multivessel coronary artery disease who underwent thoracic aortic reconstruction using the Frozen Elephant Trunk technique in combination with coronary artery bypass grafting. Given the high risk of developing ARDS, early intraoperative prophylaxis was initiated after the initiation of cardiopulmonary bypass and before circulatory arrest, and continued in the early postoperative period. No clinical or radiographic signs of ARDS were observed in the early postoperative period. After transfer to a specialized cardiac surgery unit, no signs of respiratory failure were observed throughout the hospitalization.

DIGITAL TECHNOLOGIES IN MEDICINE AND HEALTHCARE

197-204 24
Abstract

Introduction. In modern clinical practice, the interpretation of diagnostic data is often based on the physician's subjective experience, which determines variability of decisions and increases the likelihood of diagnostic errors. The imperatives of evidence-based medicine necessitate the implementation of standardized mathematical approaches to improve the accuracy of clinical judgments. The Bayesian Multiplier Factor (BMF) is one of the tools frequently used for decision-making based on a probabilistic approach.

Aim: To systematize the methodology for BMF application in clinical practice; to demonstrate calculation algorithms using model examples and substantiate the potential of the tool for objectifying diagnostic test assesment.

Material and methods. Six clinical scenarios were analyzed, covering genetic diagnostics, prenatal screening, therapy, and infectious pathology. Mathematically, BMF was defined as the likelihood ratio, calculated using sensitivity (Se) and specificity (Sp): for a positive test result, BMF– = Se / (1-Sp), for a negative test result, BMF+ = (1-Se)/ Sp. The strength of evidence was interpreted using the verified Jeffreys scale. The posterior probability of pathology was calculated using Bayes' theorem, using the prior risk as the baseline propensity.

Results. A wide range of BMF values was recorded: from 0.101 (ruling out celiac disease) to 950 (verifying malaria). With a prior risk of Down syndrome of 0.5% and a BMF of 21.25, the posterior probability was 9.6%. For familial hypercholesterolemia, with a baseline risk of 40% and a BMF of 90, the resulting risk reached 97.8%. A negative test for celiac disease (BMF of 0.10) reduced the probability of pathology from 20% to 2.1%. The birth of a healthy boy to a hemophilia carrier (BMF of 0.5) reduced the risk from 50% to 33.3%.

Conclusion. The application of BMF ensures a transition from intuitive judgment to the quantitative assessment of diagnostic information. BMF values > 1 support a diagnosis, while BMF values < 1 support it. The effectiveness of the tool is modulated by prior probability: the diagnostic value of a test varies depending on the underlying risk. Implementation of the algorithm minimizes cognitive biases; online calculators or the Fagan nomogram are recommended for clinical use.

205-213 26
Abstract

Introduction. Bronchial asthma (BA) remains one of the main health problems. Therefore, the search for objective, effortless methods of ASTHMA control from the patient and special equipment remains an urgent task. The standard approach to controlling asthma symptoms is episodic and retrospective, preventing timely detection of signs of deterioration in patients. In this article, we identify the possibilities of analyzing voice biomarkers for remote screening of asthma.

Aim: To identify acoustic parameters of speech those differ statistically significantly in patients with bronchial asthma and practically healthy individuals.

Material and Methods. The data for the analysis were voice recordings of 38 men (group 1.1) and 60 women (group 1.2) with bronchial asthma, as well as voice recordings of control groups of 57 healthy men (group 2.1) and 106 women (group 2.2). The acoustic analysis was performed using the Praat v 6.4.35 program, which was used to calculate spectral and temporal features, and Python v.3.11.4, which was used to calculate the parameters of the randomness and complexity of the pitch frequency. Acoustic and prosodic parameters of speech were calculated. Classification and testing were performed on all input attributes for five classifiers (LogisticRegression, randomForest, SVM_RBF, MLP, XGBoost).

Results. The most informative features for the binary classification of healthy individuals are mfcc_01_mean, mfcc_10_mean, shimmer local for men and mfcc_01_mean, pitch_mean, approximantropy for women. The affiliation of the leading features to three different groups of parameters confirms the multidimensional nature of voice changes in asthma.Speech parameters have gender specificity in bronchial asthma, which necessitates the construction of separate classifiers for men and women. More rigorous validation using the LOPO scheme and the randomForest classification algorithm confirmed the high generalizing ability of the models. For men, F1 = 0.84 [0.75; 0.91] and for women, F1 = 0.94 [0.90; 0.98] with an AUC ROC of 0.92 and 0.96, respectively. Using only the three most informative features, the randomForest model in the LOPO scheme achieved an F1 measure of 0.89 [0.82; 0.94] for women and 0.77 [0.68; 0.85] for men. The shuffle test showed that the classification results are not random for both men and women. The difference in the F1 measure between the initial model and after random mixing of class labels was 0.24 for men and 0.47 for women.

Conclusions. The speech parameters of patients with bronchial asthma significantly differ from healthy individuals in temporal, spectral, and nonlinear features. The degree and nature of the differences are sex-specific, which requires separate analysis for men and women. In women, the changes cover a wider range of parameters, which is consistent with the greater severity of asthma caused by anatomical, hormonal and immunological factors. The results obtained confirm the applicability of voice analysis of free speech as a tool for passive monitoring of bronchial asthma.

214-224 19
Abstract

Introduction. Early diagnosis of malignant skin neoplasms (MSN) is critical for prognosis, but a shortage of oncodermatologists in Russian regions limits screening coverage. Clinical decision support systems (CDSS) based on mobile dermoscopy represent a promising tool; proof of diagnostic effectiveness and equipping of primary care remain primary preconditions, while at the stage of clinical integration the interpretability of system output and standardization of patient routing become critical.

Aim: To assess the concordance between the conclusions of the Melanoscope AI clinical decision support system (hereafter, the system) and independent expert dermoscopic evaluation, and the change in the conclusions of a general practitioner after exposure to the system output in a screening setting.

Material and Methods. A single-center prospective pilot study was performed across four screening sessions (June 2025–April 2026). The material comprised dermoscopic images – one per examinee, of the lesion judged most suspicious on visual examination – from 176 participants. Concordance was assessed between the system's conclusions (malignant/benign) and the expert conclusion formed before exposure to the system's output. Lesions assessed by the expert as malignant were confirmed histologically; benign cases were not verified morphologically (partial differential verification). The change in concordance between a general practitioner's (GP) conclusions and the expert conclusion on the same cases, before and after exposure to the system's output, was assessed using the exact McNemar test.

Results. Agreement between the binary classification of the system and the independent expert conclusion across 176 lesions was 88.6% (95% CI 83.0–92.9), specificity 88.3% (82.5–92.7), positive predictive value 20.0% (6.8–40.7). All five histologically confirmed malignant neoplasms (3 melanomas and 2 basal cell carcinomas) were assigned by the system to the red routing zone; false-negative decisions could not be identified under the reference standard applied, since benign cases were not verified histologically. Six patients with dysplastic nevi were assigned to dynamic follow-up. Concordance between the GP's conclusions and the expert conclusion increased from 71.0% (63.9–77.2) to 82.4% (76.1–87.3); the gain was 11.4 percentage points (6.7–16.3), exact McNemar test p = 1.9·10–⁶.

Conclusion. All histologically confirmed malignant neoplasms were assigned by the system to the red routing zone; however, sensitivity and the safety of ruling out malignancy are not established by this pilot study, owing to the small number of events and the absence of morphological verification of negative cases. Concordance between the GP's conclusions and the expert conclusion increased after exposure to the system's output. Multicenter verification of the system's decision concordance is needed on a larger cohort of examinees under population screening conditions.

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