ПРЕИМУЩЕСТВА И НЕДОСТАТКИ ПРОТЕЗА КЛАПАНА СЕРДЦА С ДИНАМИЧЕСКИМ АДАПТИВНЫМ КАРКАСОМ В СРАВНЕНИИ С КЛАССИЧЕСКИМ КАРКАСНЫМ: ОЦЕНКА ГИДРОДИНАМИЧЕСКИХ ПОКАЗАТЕЛЕЙ БИОПРОТЕЗОВ «ТИАРА» И «ЮНИЛАЙН»

HighlightsThe «TiAra» bioprosthetic heart valves have better hemodynamic characteristics, such as higher effective orifice area and a lower mean pressure gradient.The «UniLine» bioprosthetic heart valve demonstrated better closing dynamic, expressed in a smaller regurgitation volume. Aim. To assess hydrodynamic characteristics of the «TiAra» bioprosthetic heart valve with flexible supporting frame compared with the classic stented «UniLine» bioprosthetic aortic valve.Methods. Using the Vivitro Pulse Duplicator (Vivitro Labs, Canada), we simulated the function of the heart via generating pulsatile flow to analyze bioprosthetic heart valves. To comprehensively assess the bioprosthesis function, three valves of each standard size (21, 23, 25 mm) were submitted to hydrodynamic testing, thus making a sample of nine bioprostheses of each model. The article provides the analysis of  the effective orifice area, mean pressure gradient, regurgitation volume, and assessment of the statistical sensitivity of the parameters between groups at p = 0.05.Results. The assessment revealed that the «TiAra» bioprosthesis has bigger effective orifice area (p = 0.006) and lower mean pressure gradient (p = 0.02): 1.6–2.2 cm2 and 3.6–6.3 mmHg versus 1.08–1.73 cm2 and 4.8–12.1 mmHg, respectively. The regurgitation volume, however, was lower in the «UniLine» bioprostheses 0.8–4.1 mL/cycle versus 6.2–9.0 mL/cycle (p = 0.0004).Conclusion. Despite the fact that both studied models showed good hydrodynamic performance, the prosthesis with the flexible supporting frame («TiAra») showed better results regarding its effectiveness in vitro via presenting with bigger effective orifice area and lower mean pressure gradient. At the same time, the «UniLine» stented bioprosthesis had lower regurgitation volume, i.e. better closing dynamics.Основные положенияБиопротезы клапанов сердца «ТиАра» обладают лучшими гемодинамическими характеристиками: более высокой эффективной площадью отверстия и меньшим средним транспротезным градиентом.Биопротез «ЮниЛайн» продемонстрировал более качественную запирательную функцию, выраженную в меньшем объеме регургитации. Цель. Оценка гидродинамических характеристик биопротеза клапана сердца «ТиАра» с динамическим адаптивным опорным каркасом в сравнении с классическим каркасным биопротезом «ЮниЛайн».Материалы и методы. Исследование проводили с помощью имитации физиологического гидродинамического потока в стендовых условиях на установке Vivitro Pulse Duplicator (Vivitro Labs, Канада). Для комплексной оценки работы биопротезов тестированию подвергали по три экземпляра каждого типоразмера (21, 23, 25 мм), формируя таким образом выборки из девяти биопротезов каждой модели. В работе анализировали эффективную площадь отверстия, средний транспротезный градиент и объем регургитации, оценивая статистическую значимость различий между группами при p = 0,05.Результаты. Показано, что модель биопротеза с динамическим адаптивным опорным каркасом «ТиАра» обладает достоверно лучшими показателями эффективной площади отверстия (p = 0,006) и меньшим средним транспротезным градиентом (p = 0,02): 1,6–2,2 см2 и 3,6–6,3 мм рт. ст. против 1,08–1,71 см2 и 4,8–12,1 мм рт. ст. у биопротеза «ЮниЛайн». Объем регургитации при этом был ниже у биопротезов «ЮниЛайн», составив 0,8–4,1 против 6,2–9,0 мл/цикл соответственно (p = 0,0004).Заключение. Несмотря на то что обе исследованные модели изделий обладают хорошими гидродинамическими характеристиками, протез с динамическим адаптивным опорным каркасом («ТиАра») демонстрирует статистически достоверно лучшие результаты in vitro с позиции эффективной площади отверстия и среднего транспротезного градиента. При этом каркасный биопротез «ЮниЛайн» имеет более низкий объем регургитации, т. е. лучшую запирательную функцию

БИМАММАРНОЕ КОРОНАРНОЕ ШУНТИРОВАНИЕ: ПЯТНАДЦАТИЛЕТНИЙ ОПЫТ

HighlightsBilateral internal thoracic artery (BITA) grafting is one of the most effective methods of direct myocardial revascularization. However, its results are still contradictory, despite the worldwide trend to use more autogenous arterial conduits.This study involves more than fifteen years of data in the use of BITA in Kuzbass in coronary artery disease surgery. The findings presented in the course of the analysis confirm the need to use both internal mammary arteries more actively. Aim. To analyze long-term results of BITA grafting in terms of more than 15 years follow-up.Methods. The study included 232 patients who were admitted at the Cardiac Surgery Department for coronary artery bypass grafting (CABG). All patients were divided into 2 groups depending on usage of single or bilateral internal thoracic artery conduits. Both groups included an equal number of patients 116 (50%). Long-term results were assessed in terms of more than 15 years follow-up.Results. BITA grafting is comparable with CABG in such major adverse cardiac and cerebrovascular events as repeated myocardial revascularization, stroke, and in combined endpoint such as myocardial infarction (MI), stroke, repeated myocardial revascularization, or patient’s death within 15 years. However, the BITA group is superior to the CABG group in freedom from MI, all-cause deaths, showing a higher life expectancy after surgery (p = 0.011), and improved left ventricular ejection fraction and decreased functional class of angina. Moreover, in the present research it was confirmed that the severity of atherosclerosis in the coronary arteries is lower after bypassing with autogenous arterial conduits.Conclusion. BITA is safe procedure comparable with CABG, however, it has more advantageous long-term clinical and angiographic results.Основные положенияБимаммарное коронарное шунтирование представляет собой один из эффективных методов прямой реваскуляризации миокарда. Однако до сих пор результаты процедуры противоречивы, несмотря на мировую тенденцию применять большее количество аутоартериальных кондуитов.Настоящее исследование отражает более чем пятнадцатилетние результаты использования этого метода в хирургическом лечении ишемической болезни сердца. Выводы, полученные в ходе анализа, подтверждают необходимость активнее применять обе внутренние грудные артерии. Цель. Оценить результаты бимаммарного коронарного шунтирования (БиМКШ) по данным более чем 15-летнего наблюдения.Материалы и методы. Обследованы 232 пациента, поступившие в кардиохирургическое отделение для проведения коронарного шунтирования (КШ). Все пациенты разделены на две группы в зависимости от использования одной или двух внутренних грудных артерий. В первую и вторую группы вошло равное количество больных – по 116 (50%) в каждой. Оценены результаты отдаленного (более 15 лет) послеоперационного периода.Результаты. БиМКШ сопоставимо со стандартным КШ по таким серьезным неблагоприятным сердечно-сосудистым событиям, как повторная реваскуляризация миокарда, инсульт, а также по комбинированной конечной точке, представленной инфарктом миокарда, инсультом, повторной реваскуляризацией миокарда, смертью пациента или их сочетанием. Вместе с тем БиМКШ превосходит стандартное КШ в свободе от инфаркта миокарда, случаях смерти от любых причин, демонстрируя более высокую продолжительность жизни больных после операции (p = 0,011), а также улучшает фракцию выброса левого желудочка и снижает функциональный класс стенокардии напряжения. Кроме этого, в настоящем исследовании установлено, что выраженность атеросклероза в коронарных артериях ниже после шунтирования аутоартериальными кондуитами, что, вероятно, связано с их коронаропротективным действием.Заключение. БиМКШ является безопасной процедурой, сравнимой с классическим КШ, однако демонстрирует более благоприятные отдаленные клинические и ангиографические результаты

СРАВНИТЕЛЬНЫЙ АНАЛИЗ РЕЗУЛЬТАТОВ ХИРУРГИЧЕСКОГО ЛЕЧЕНИЯ ДИСФУНКЦИИ БИОЛОГИЧЕСКИХ ПРОТЕЗОВ МИТРАЛЬНОГО КЛАПАНА КЛАССИЧЕСКИМ МЕТОДОМ И МЕТОДОМ «ПРОТЕЗ-В-ПРОТЕЗ» С ИСПОЛЬЗОВАНИЕМ PROPENSITY SCORE MATCHING

HighlightsThe article describes the first conducted pseudorandomized comparative study of mitral valve replacement using either traditional or “valve-in-valve” techniques. AbstractAim. To compare short-term (perioperative) and medium-term (6 months) outcomes of surgical treatment of bioprosthetic mitral valve dysfunction using traditional and “valve-in-valve” methods.Methods. The study included 18 patients undergoing “valve-in-valve” replacement and 18 patients undergoing traditional mitral valve replacement (open mitral valve replacement) chosen according to the following criteria: heart disease type, predominant type of defect, age, gender, severity of the disease and the presence of concomitant pathology and using 1:1 matching on the propensity score.Results. No perioperative mortality was noted in both groups. The cardiopulmonary bypass and cross-clamping of the aorta time was significantly lower in the “valve-in-valve” group. Comparison of echocardiographic parameters revealed a decrease in the mean pulmonary arterial pressure gradient, and a decrease in the size of the heart chambers in both groups. The peak and mean transvalvular gradient were lower in the “traditional” group. There were no cases of patient-prosthesis mismatch. In the mid-term period, patients in both groups presented with a lower functional class of heart failure.Conclusion. Bioprosthetic mitral valve replacement using the “valve-in-valve” technique provides comparable clinical and hemodynamic results compared to the “traditional” technique in short-term and mid-term periods, and significantly reduces cardiopulmonary bypass and aortic cross clamping time.Основные положенияПредставлено первое псевдорандомизированное сравнительное исследование репротезирования митрального клапана классическим методом и по типу «протез-в-протез». РезюмеЦель. Сравнить непосредственные (госпитальные) и среднеотдаленные результаты хирургического лечения дисфункции биологических протезов митрального клапана стандартным методом и по типу «протез-в-протез».Материалы и методы. С использованием статистического анализа propensity score matching в соотношении 1:1 к 18 пациентам группы «протез-в-протез» методом «ближайшего соседа» подобраны 18 больных, получивших классическое протезирование митрального клапана (полное иссечение элементов протеза с последующей реимплантацией нового протеза), по критериям соответствия: этиология поражения сердца, преобладающий тип порока, возраст, пол, степень тяжести заболевания и характер сопутствующей патологии.Результаты. Операционной летальности в обеих группах не наблюдалось. Длительность искусственного кровообращения и пережатия аорты была статистически значимо ниже в группе реимплантации «протез-в-протез». Сравнение эхокардиографических параметров показало снижение среднего давления в легочной артерии и уменьшение размера камер сердца в обеих группах. Пиковый и средний транспротезный градиенты были ниже в группе стандартного протезирования. Пациент-протезного несоответствия не зафиксировано ни в одном случае. В среднеотдаленном периоде у пациентов обеих групп отмечено снижение функционального класса сердечной недостаточности.Заключение. Репротезирование митрального клапана биологическими протезами методом «клапан-в-клапан» демонстрирует сопоставимые с классической методикой клинические и гемодинамические результаты госпитального и среднеотдаленного периодов, при этом позволяет значительно снизить время искусственного кровообращения и пережатия аорты

ПЕРВЫЙ ОПЫТ ИСПОЛЬЗОВАНИЯ «КЕМАНГИОПРОТЕЗА» ПРИ ОПЕРАЦИИ NORWOOD – SANO

HighlightsThe article presents a unique clinical case of correction of hypoplastic left heart syndrome with Norwood procedure using a “KemAngioprosthesis” vascular xenograft as a Sano shunt. AbstractWe present the first successful clinical case of using the “KemAngioprosthesis” vascular xenograft in the pulmonary position as the Sano shunt in the Norwood procedure for correction of hypoplastic left heart syndrome. A newborn baby (gestation period of 38 weeks) diagnosed with congenital heart disease, and hypoplastic left heart syndrome was admitted to the Research Institute for Complex Issues of Cardiovascular Diseases. The child survived the first stage of the modified Norwood procedure (Sano shunt) using a biological vascular prosthesis. This clinical case showed that using the “KemAngioprosthesis” vascular xenograft in Norwood procedure to modify pulmonary blood flow by creating an anastomosis between the right ventricle and bifurcation of the pulmonary artery is effective and safe in the short-term period.Основные положенияВ статье представлен уникальный случай гемодинамической коррекции синдрома гипоплазии левых отделов сердца. При операции Norwood в качестве шунта Sano использован сосудистый ксенографт «КемАнгиопротез» (ЗАО «НеоКор», Кемерово). АбстрактПредставлен первый успешный опыт применения артериального аутографта «КемАнгиопротез» в легочной позиции при операции Norwood – Sano, направленной на гемодинамическую коррекцию синдрома гипоплазии левого желудочка. В НИИ КПССЗ поступил новорожденный со сроком гестации 38 нед. с диагнозом: врожденный порок сердца, синдром гипоплазии левых отделов сердца. Ребенку успешно выполнен первый этап гемодинамической коррекции методом Norwood – Sano с использованием биологического сосудистого протеза. Данный клинический случай показал, что применение «КемАнгиопротеза» при операции Norwood – Sano для модификации легочного кровотока путем создания анастомоза между правым желудочком и бифуркацией легочной артерии является эффективным и безопасным в госпитальном периоде

Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial

Background: Semaglutide, a GLP-1 receptor agonist, reduces the risk of major adverse cardiovascular events (MACE) in people with overweight or obesity, but the effects of this drug on outcomes in patients with atherosclerotic cardiovascular disease and heart failure are unknown. We report a prespecified analysis of the effect of once-weekly subcutaneous semaglutide 2·4 mg on ischaemic and heart failure cardiovascular outcomes. We aimed to investigate if semaglutide was beneficial in patients with atherosclerotic cardiovascular disease with a history of heart failure compared with placebo; if there was a difference in outcome in patients designated as having heart failure with preserved ejection fraction compared with heart failure with reduced ejection fraction; and if the efficacy and safety of semaglutide in patients with heart failure was related to baseline characteristics or subtype of heart failure. Methods: The SELECT trial was a randomised, double-blind, multicentre, placebo-controlled, event-driven phase 3 trial in 41 countries. Adults aged 45 years and older, with a BMI of 27 kg/m2 or greater and established cardiovascular disease were eligible for the study. Patients were randomly assigned (1:1) with a block size of four using an interactive web response system in a double-blind manner to escalating doses of once-weekly subcutaneous semaglutide over 16 weeks to a target dose of 2·4 mg, or placebo. In a prespecified analysis, we examined the effect of semaglutide compared with placebo in patients with and without a history of heart failure at enrolment, subclassified as heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, or unclassified heart failure. Endpoints comprised MACE (a composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death); a composite heart failure outcome (cardiovascular death or hospitalisation or urgent hospital visit for heart failure); cardiovascular death; and all-cause death. The study is registered with ClinicalTrials.gov, NCT03574597. Findings: Between Oct 31, 2018, and March 31, 2021, 17 604 patients with a mean age of 61·6 years (SD 8·9) and a mean BMI of 33·4 kg/m2 (5·0) were randomly assigned to receive semaglutide (8803 [50·0%] patients) or placebo (8801 [50·0%] patients). 4286 (24·3%) of 17 604 patients had a history of investigator-defined heart failure at enrolment: 2273 (53·0%) of 4286 patients had heart failure with preserved ejection fraction, 1347 (31·4%) had heart failure with reduced ejection fraction, and 666 (15·5%) had unclassified heart failure. Baseline characteristics were similar between patients with and without heart failure. Patients with heart failure had a higher incidence of clinical events. Semaglutide improved all outcome measures in patients with heart failure at random assignment compared with those without heart failure (hazard ratio [HR] 0·72, 95% CI 0·60-0·87 for MACE; 0·79, 0·64-0·98 for the heart failure composite endpoint; 0·76, 0·59-0·97 for cardiovascular death; and 0·81, 0·66-1·00 for all-cause death; all pinteraction>0·19). Treatment with semaglutide resulted in improved outcomes in both the heart failure with reduced ejection fraction (HR 0·65, 95% CI 0·49-0·87 for MACE; 0·79, 0·58-1·08 for the composite heart failure endpoint) and heart failure with preserved ejection fraction groups (0·69, 0·51-0·91 for MACE; 0·75, 0·52-1·07 for the composite heart failure endpoint), although patients with heart failure with reduced ejection fraction had higher absolute event rates than those with heart failure with preserved ejection fraction. For MACE and the heart failure composite, there were no significant differences in benefits across baseline age, sex, BMI, New York Heart Association status, and diuretic use. Serious adverse events were less frequent with semaglutide versus placebo, regardless of heart failure subtype. Interpretation: In patients with atherosclerotic cardiovascular diease and overweight or obesity, treatment with semaglutide 2·4 mg reduced MACE and composite heart failure endpoints compared with placebo in those with and without clinical heart failure, regardless of heart failure subtype. Our findings could facilitate prescribing and result in improved clinical outcomes for this patient group. Funding: Novo Nordisk

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

The Prognostic Value of Peripheral Artery Diseases in Patients with ST-Segment Elevation Myocardial Infarction

Hypothesis. To evaluate the clinical and prognostic role of haemodynamically insignificant stenosis of the extracranial arteries (ECA) and lower extremity arteries (LEA) among patients with ST-segment elevation myocardial infarction (STEMI). Patients and Methods. The study sample consisted of 423 patients with STEMI who were consecutively admitted to the Kemerovo Cardiological Centre. Results. The prevalence of polyvascular diseases (PVD), as defined by an increased intima-media thickness (IMT) of the common carotid artery or by stenosis of the ECA or LEA, was 95%. Among patients with ECA or LEA, the case fatality rate of those with stenosis with occlusion of less than 30% of the vessel lumen was 5.7%, whereas the case fatality rate among patients with stenosis with occlusion of more than 30% of the vessel lumen was 15.1% (χ2=13.68, P=0.003). Using the GRACE score model, together with the determination of additional factors (congestive heart failure, PVD, prior stroke, and smoking status), we developed an improved model (KemScore) for death risk stratification for a 12-month period. The value of the AUC for our model (KemScore) was 0.83 (95% CI = 0.76–0.90), which was significantly higher than the initial GRACE score value of 0.71 (95% CI = 0.63–0.79)

The Prognostic Value of Peripheral Artery Diseases in Patients with ST-Segment Elevation Myocardial Infarction

Hypothesis. To evaluate the clinical and prognostic role of haemodynamically insignificant stenosis of the extracranial arteries (ECA) and lower extremity arteries (LEA) among patients with ST-segment elevation myocardial infarction (STEMI). Patients and Methods. The study sample consisted of 423 patients with STEMI who were consecutively admitted to the Kemerovo Cardiological Centre. Results. The prevalence of polyvascular diseases (PVD), as defined by an increased intima-media thickness (IMT) of the common carotid artery or by stenosis of the ECA or LEA, was 95%. Among patients with ECA or LEA, the case fatality rate of those with stenosis with occlusion of less than 30% of the vessel lumen was 5.7%, whereas the case fatality rate among patients with stenosis with occlusion of more than 30% of the vessel lumen was 15.1% ( 2 = 13.68, = 0.003). Using the GRACE score model, together with the determination of additional factors (congestive heart failure, PVD, prior stroke, and smoking status), we developed an improved model (KemScore) for death risk stratification for a 12-month period. The value of the AUC for our model (KemScore) was 0.83 (95% CI = 0.76-0.90), which was significantly higher than the initial GRACE score value of 0.71 (95% CI = 0.63-0.79)

Vascular endothelial growth factor improves physico-mechanical properties and enhances endothelialization of poly(3-hydroxybutyrate-co-3-hydroxyvalerate)/poly(ε-caprolactone) small-diameter vascular grafts in vivo

The combination of a natural hydrophilic polymer poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) and a synthetic hydrophobic polymer poly(ε-caprolactone) (PCL) is promising for the preparation of biodegradable and biocompatible small-diameter vascular grafts for bypass surgery. However, physico-mechanical properties and endothelialization rate of PHBV/PCL grafts are poor. We suggested that incorporation of vascular endothelial growth factor (VEGF) into PHBV/PCL grafts may improve their physico-mechanical properties and enhance endothelialization. Here we compared morphology, physico-mechanical properties, and in vivo performance of electrospun small-diameter vascular grafts prepared from PHBV/PCL with and without VEGF. Structure of the graft surface and physico-mechanical properties were examined by scanning electron microscopy and universal testing machine, respectively. Grafts were implanted into rat abdominal aorta for 1, 3, and 6 months with the further histological, immunohistochemical, and immunofluorescence examination. PHBV/PCL grafts with and without VEGF were highly porous and consisted mostly of nanoscale and microscale fibers, respectively. Mean pore diameter and mean pore area were significantly lower in PHBV/PCL/VEGF compared to PHBV/PCL grafts (1.47 µm and 10.05 µm2; 2.63 µm and 47.13 µm2, respectively). Durability, elasticity, and stiffness of PHBV/PCL grafts with VEGF were more similar to internal mammary artery compared to those without, particularly 6 months postimplantation. Both qualitative examination and quantitative image analysis showed that three-fourths of PHBV/PCL grafts with VEGF were patent and had many CD31-, CD34-, and vWF-positive cells at their inner surface. However, all PHBV/PCL grafts without VEGF were occluded and had no or a few CD31-positive cells at the inner surface. Therefore, VEGF enhanced endothelialization and improved graft patency at all the time points in a rat abdominal aorta replacement model. In conclusion, PHBV/PCL grafts with VEGF have better biocompatibility and physico-mechanical properties compared to those without. Incorporation of VEGF improves graft patency and accelerates formation of endothelial cell monolayer