Ишемическая болезнь сердца — одна из главных причин смертности и инвалидизации населения. Важнейший компонент комплексной терапии атеросклероза — реваскуляризация миокарда. Клопидогрель благодаря приемлемым для клинической практики свойствам долгое время используют в антитромбоцитарной терапии. Наибольшая доказательная база среди всех ингибиторов P2Y12-рецепторов тромбоцитов позволяет применять его как в рядовых, так и в сложных клинических ситуациях. Особенности фармакокинетики и фармакодинамики препарата влияют на его использование. Современные рекомендации определяют место и роль клопидогреля в лечении больных до и после реваскуляризации. В статье рассмотрены различные аспекты антиагрегантной терапии с учетом рисков пациента на основании европейских рекомендаций по лечению больных острым и хроническим коронарным синдромом. Поступила в редакцию 21 сентября 2021 г. Исправлена 16 октября 2021 г. Принята к печати 18 октября 2021 г. Финансирование Исследование не имело спонсорской поддержки. Конфликт интересов Авторы заявляют об отсутствии конфликта интересов.

Abstract Background The guideline treatments based on a relatively broad set of enrollment criteria inhibits the personalized evidence-based approach. Personalized evidence-based medicine (EBM) involves the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Objective We report the 1-year follow-up data of the Atrial Fibrillation Registry, focusing on the relationship between personalized EBM and guideline-adherent anticoagulation therapy use and the occurrence of major clinical adverse events. Methods 2683 patients at high risk for stroke and 1-year follow-up were enrolled in study. The primary endpoint was the percentage of guideline-based and personalized EBM recommendations acted on by clinicians. Secondary endpoints include the following: outcomes for all-cause mortality, thromboembolism (TE), bleeding, and the composite endpoints. Results From 2683 patients, 1971 (73.5%) EMR were guideline adherent and only 824 (30.7%) of them were personalized EBM anticoagulation therapy adherent, whilst 712 (26.5%) were non-guideline adherent and 1147 (42.8%) were guideline adherent but non-personalized EBM adherent. The composite endpoint of cardiovascular death, any TE or bleeding was significantly lower in personalized EBM adherent patients during 1-year follow-up (P=0.02). The endpoint of all cause death and any TE is increased by >20% by guideline adherent but non-personalized EBM adherent treatment [hazard ratio (HR) 1.254 (95% CI 0.931; 1.689)] and >80% non-guideline adherent and non-personalized EBM adherent treatment [HR 1.892 (95% CI 1.359; 2.635)]. For the composite endpoint of cardiovascular death, any TE or bleeding, guideline adherent but non-personalized EBM adherent treatment increased risk by >40% [HR 1.454 (95% CI 1.037; 2.040)], and non-guideline adherent and non-personalized EBM adherent treatment by >110% [HR 2.113 (95% CI 1.453; 3.074)]. Conclusion Personalized EBM anticoagulation management is associated with significantly better outcomes, including those related to the composite endpoint of cardiovascular death, any TE or bleeding in high-risk patients. Funding Acknowledgement Type of funding sources: None.

Abstract Background New clinical decision support system (CDSS) MedicBK use algorithms for presents treatment suggestions in frame of guideline-based therapy and personalized evidence-based medicine (EBM) therapy. Objective We hypothesized that clinicians with access to CDSS (MedicBK) would provide more personalized EBM anticoagulation treatment and improve outcomes. Methods 2683 patients at high risk for stroke and 1-year follow-up were enrolled in study and analyzed by CDSS and core laboratory. The primary endpoint was the quantify the performance of the CDSS (MedicBK) algorithm. Secondary endpoints include the following: outcomes for all-cause mortality, thromboembolism (TE), bleeding, and the composite endpoints. Results From 2683 patients, 1971 patients were core laboratory-classified as guideline adherent and 824 of them were personalized evidence-based therapy adherent. All 1971 (100%) patients were also detected as guideline adherent by CDSS, whereas only 748 (90.8%) were classified as personalized EBM adherent. The sensitivity for identifying patients with guideline and personalized EBM therapy adherence is therefore 100% and 90.8%. 712 and 1935 patients classified as guideline and personalized EBM therapy non-adherent by the core laboratory. All of them CDSS confirmed the absence of adherence, resulting in a specificity of 100%. The PPV and NPV of detecting with or without adherence to guideline, respectively, are 100% (1971 of 1971 pts) and 100% (712 of 712 pts). The PPV and NPV of detecting personalized EBM therapy adherence or non-adherence, respectively, are 100% (748 of 748 pts) and 96.1% (1859 of 1935 pts). The composite endpoint of cardiovascular death, any thromboembolism (TE) or bleeding was significantly lower in personalized EBM adherent patients during 1-year follow-up (P=0.02) and increased risk by >40% [HR 1.454 (95% CI 1.037; 2.040)], and non-guideline adherent and non-personalized EBM adherent treatment by >110% [HR 2.113 (95% CI 1.453; 3.074)]. Conclusion MedicBK appears to be promising to improve adherence to guideline and personalized EBM therapy in general practice. Personalized EBM anticoagulation management is associated with significantly better outcomes. Funding Acknowledgement Type of funding sources: None.

Coronary artery disease (CAD) remains one of the leading causes of death in developed industrial countries. Timely and effective medical care for CAD patients depends on availability and application of endovascular methods for CAD treatment. Percutaneous coronary intervention (PCI) using drug- eluting stents allows to achieve good clinical results even in most severe patients. The issues of personalized invasive treatment for patients with chronic coronary syndrome and optimal prevention of recurrent clinical events in survivors of acute coronary syndrome and PCI remain relevant.One of most important and unresolved problems in the pathophysiology of CAD is assessment of the nature of the inflammatory reaction that develops in the coronary vessels and myocardium in response to ischemic damage and PCI. Clinical studies focused on exploring correlation between the pro-inflammatory parameters of the patient’s status and the rate of secondary adverse events and aimed at revealing triggers of systemic and local inflammation are of great interest. Such a trigger could be the intestinal endotoxin (ET) which is capable of inducing systemic inflammation and, therefore, plays a significant role in the atherogenesis. A relationship between the endotoxin and cytokine system parameters should be investigated to develop a therapeutic concept for supporting CAD patients, including individuals after PCI. Parameters of systemic endotoxemia could be used as additional factors in developing the biomarker-based approach to identify patients with active inflammation or fibrosis. This could result in development of specific therapy aimed at suppressing pro-inflammatory mediators and protecting the heart from inflammation.

Актуальность. Ишемический инсульт является одной из ведущих причин смертности и инвалидизации во всем мире. Одним из перспективных методов профилактики ишемического инсульта является селективная интракаротидная церебральная гипотермия. Однако результаты исследований не позволяют сделать вывод о том, насколько эффективным будет применение этого метода у человека и каким выраженным при этом будет влияние на системную температуру. Цель. Изучить влияние селективной интракаротидной церебральной гипотермии на размер очага ишемического инсульта у мини-пигов, определить оптимальный период проведения гипотермии и выраженность влияния интракаротидной гипотермии на системную температуру. Методы. Исследование проводилось на мини-свиньях весом от 30 до 70 кг и включало два этапа. На первом этапе лабораторные животных разделили на две группы: контрольная группа (n = 4) и группа интракаротидной гипотермии в течение 3 ч, захватывающей периоды до и после реперфузии (n = 2). На втором этапе животных также разделили на две группы: группа гипотермии в течение 1,5 ч до реперфузии (n = 2) и группа гипотермии в течение 1,5 ч после реперфузии (n = 2). Методика моделирования ишемического инсульта была одинаковой во всех группах и заключалась в лобно-височной краниотомии и пережатии средней мозговой артерии на 3 ч. Интракаротидную гипотермию осуществляли посредством инфузии в восходящую глоточную артерию 0,9% раствора NaCl, охлажденного до +4 °С. Через 48 ч после начала эксперимента лабораторным животным выполняли магнитно-резонансную томографию головного мозга для определения размера очага инсульта. Результаты. Размер очага инсульта в контрольной группе составил в среднем 10,75%, в группе гипотермии до реперфузии — 10,95%, а в группе гипотермии после реперфузии — 1,65% объема полушария мозга. Размер очага инсульта в группе гипотермии в течение 3 ч определить не удалось по причине осложнений, развившихся у животных во время операции и послеоперационном периоде. Влияние интракаротидной гипотермии на системную температуру у животного весом 65 кг составило 0,4 °С. Заключение. Установлено выраженное уменьшение очага ишемического инсульта при интракаротидной гипотермии в течение 1,5 ч после реперфузии. Интракаротидная гипотермия не оказывает выраженного влияния на системную температуру. Поступила в редакцию 2 мая 2020 г. Исправлена 20 мая 2020 г. Принята к печати 25 мая 2020 г. Финансирование Работа выполнена при поддержке гранта Российского фонда фундаментальных исследований (проект № 18-415-540025). Конфликт интересов Авторы заявляют об отсутствии конфликта интересов. Вклад авторов Концепция и дизайн работы: Е.И. Фартаков, В.В. Ломиворотов, Е.И. Кретов, А.Р. Таркова Сбор и анализ данных: Д.У. Малаев, А.А. Бойков, А.А. Прохорихин, Д.В. Волченко, И.С. Зыков, П.О. Селезнев Написание статьи: Е.И. Фартаков, Д.У. Малаев, А.Р. Таркова Редактирование статьи: Е.И. Кретов, В.В. Ломиворотов, В.И. Байструков, .И. Грачев, Д.С. Сергеевичев, А.М. Чернявский, Е.И. Кретов Утверждение окончательной версии: все авторы

Background. The intravenous administration of tissue plasmongen activator within 4.5 h of the onset of acute ischaemic stroke is known to improve the treatment outcomes significantly. However, in 2015, five large studies simultaneously demonstrated the superiority of a mechanical revascularisation strategy over a drug-based approach. As a results of these studies, the updated guidelines, providing an advantage of mechanical thromboextraction.Aim. To evaluate the effectiveness of the combined system for mechanical thrombus extraction.Methods. We prepared a prototype of a combined system for mechanical thrombextraction in ischaemic stroke. We performed a trial on a laboratory animal in order to assess the efficiency of the system.Results. Our results show that mechanical thrombus extraction using the domestic prototype of the combined thrombextraction system was highly efficient. Complete restoration of blood flow was observed in the previously occluded segment.Conclusion. Our study demonstrated prototype of a combined system for mechanical thrombus extraction effectiveness in preclinical study.Received 10 December 2020. Revised 16 December 2020. Accepted 21 December 2020.Funding: The work is supported by a grant (project No. 056-00042-20-00).Conflict of interest: Authors declare no conflict of interest.

Background. In 30% to 87% patients undergoing carotid artery stenting (CAS), new ischaemic lesions (NILs) of the brain are detected on magnetic resonance imaging (MRI). According to some authors, in 60% cases who undergo CAS via transfemoral (TF) access, NILs are also found in the contralateral and other vascular pools of the brain that are not directly related to the target carotid artery, most likely a result of the endovascular manipulation of the catheter on the aortic arch. An alternative access site for CAS is transradial (TR) access. Theoretically, with TR access, the catheter’s contact with the aortic arch is reduced, particularly with an intervention on the right internal carotid artery, and the risk of embolic events is possibly reduced. However, this aspect has not yet been explored.Aim. The aim of this study was to identify the predictors of NILs of the brain in patients undergoing CAS via the TR and TF approaches.Methods. The study included 96 patients with indications for CAS. Patients were randomised in a 1:1 ratio to either the TR (n = 48) or TF (n = 48) groups. All patients underwent diffusion-weighted imaging MRI before and 12 to 24 hours after the procedure. Multiple logistic regression with step-by-step turning off of variables was used to determine the predictors of NIL.Results. A total of 40 clinical, demographic, instrumental and intraoperative variables were analysed. Based on the results of single regression analysis, 6 predictors (age, male sex, hypertension, history of percutaneous transluminal coronary angioplasty, intersection of the aortic arch and type II/III aortic arch) were included in the multivariate model. From the final multivariate analysis, it was found that age, intersection of the aortic arch and type II/III aortic arch are independent predictors of NILs after CAS.Conclusion. Patient age, type II/III aortic arch and need for a catheter to cross the aortic arch are independent predictors of NILs during carotid stenting. Received 9 January 2020. Revised 21 February 2020. Accepted 25 February 2020. Funding: The study did not have sponsorship. Conflict of interest: Authors declare no conflict of interest.

Peripheral artery disease (PAD) is one of the most common cardiovascular diseases with serious sequelae. Every year, 120–500 amputations are performed per 1 million people worldwide. The severe consequences of amputation include the mental trauma caused by loss of a limb, disability and a real risk of death for the patient, since the mortality rate associated with the development of gangrene remains extremely high. PAD is most frequently located in the femoral-popliteal segment, which is the longest vascular segment in the human body. Over the past decade, the endovascular approach has become the main therapeutic strategy for PAD, given its lower risk of complications and comparable efficacy to open interventions. Femoral-popliteal stenting provides advantages over balloon angioplasty, preventing vessel wall recoil and providing necessary frame support.This review aims to describe the latest progress of endovascular surgery for the treatment of femoral-popliteal artery disease and to discuss its limitations.The introduction of nitinol stents and new drug coated stents into clinical practice has improved the results of femoral-popliteal endovascular treatment. Despite this, stent failure remains a pressing problem that significantly impacts the results of endovascular treatment of atherosclerotic lesions of lower limb arteries.Received 6 June 2019. Revised 8 October 2019. Accepted 10 October 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.Author contributionsConception and design: D.U. Malaev, A.R. Tarkova, A.A. Prokhorkhin, A.A. BoykovDrafting the article: D.U. Malaev, A.A. Prokhorkhin, A.A. BoykovCritical revision of the article: D.L. Merson, A.Yu. Vinogradov, V.I. Baystrukov, E.I. KretovFinal approval of the version to be published: D.U. Malaev, A.R. Tarkova, A.A. Prokhorkhin, D.L. Merson, A.Yu. Vinogradov, V.I. Baystrukov, A.A. Boykov, E.I. Kretov, M.V. Pryamov

Заболевание артерий нижних конечностей является одной из самых распространенных сердечно-сосудистых заболеваний. Ежегодно в мире выполняется от 120 до 500 ампутаций на 1 млн населения. Тяжесть ампутации проявляется как психической травмой, обусловленной потерей конечности и инвалидизацией, так и реальным риском гибели больного, поскольку летальность при ампутации из-за заболевания артерий нижних конечностей чрезвычайно высокая. Особый интерес представляет бедренно-подколенный сегмент, который является самым длинным сосудистым сегментом в организме человека и наиболее частой локализацией заболевания артерий нижних конечностей. Внедрение в клиническую практику нитиноловых стентов и новых лекарственных покрытий улучшили результаты эндоваскулярного лечения данного сегмента. Несмотря на это, актуальной проблемой является поломка стентов, которая оказывает значительное влияние на результаты эндоваскулярного лечения атеросклеротического поражения артерий нижних конечностей. С учетом более низкого риска осложнений, по сравнению с «открытыми» вмешательствами, при сопоставимой эффективности эндоваскулярный подход за последнее десятилетие стал основной терапевтической стратегией. Стентирование бедренно-подколенного сегмента позволяет решить недостатки баллонной ангиопластики, предотвратить повторное сужение просвета и обеспечить необходимую каркасную поддержку. Целью данного обзора является отражение последних достижений и недостатков эндоваскулярной хирургии в лечение бедренно-подколенного сегмента. Поступила в редакцию 6 июня 2019 г. Исправлена 8 октября 2019 г. Принята к печати 10 октября 2019 г. Конфликт интересов Авторы заявляют об отсутствии конфликта интересов. Финансирование Исследование не имело спонсорской поддержки. Вклад авторов Концепция и дизайн: Д.У. Малаев, А.Р. Таркова, А.А. Прохорихин, А.А. Бойков Написание статьи: Д.У. Малаев, А.А. Прохорихин, А.А. Бойков Исправление статьи: Д.Л. Мерсон, А.Ю. Виноградов, В.И. Байструков, Е.И. Кретов Утверждение окончательной версии: все авторы

Актуальность. У 30–87% пациентов после каротидной ангиопластики со стентированием на магнитно-резонансной томографии обнаруживаются новые ишемические очаги головного мозга. При каротидной ангиопластике со стентированием трансфеморальным доступом в 60% случаев эти очаги также обнаруживаются в контралатеральной и других сосудистых бассейнах головного мозга, не связанных с целевой сонной артерией. Наиболее вероятная причина — эндоваскулярная манипуляция катетером на дуге аорты. Альтернативным при каротидной ангио­пластике со стентированием является трансрадиальный доступ. Теоретически при трансрадиальном доступе снижается контакт катетера с дугой аорты, особенно при вмешательстве на правой внутренней сонной артерии, и, возможно, снижается риск эмболических событий, однако данный аспект не изучен. Цель. Выявление предикторов новых ишемических очагов головного мозга при каротидной ангиопластике со стентированием трансрадиальным и трансфеморальным доступами. Методы. В исследование включены 96 пациентов с показаниями к каротидной ангиопластике со стентированием. Далее пациенты рандомизированы 1 : 1 на группы трансрадиального (n = 48) и трансфеморального (n = 48) доступов. До и через 12–24 ч после процедуры всем пациентам проводилась диффузионно-взвешенная магнитно-резонансная томография головного мозга. Для определения предикторов новых ишемических очагов использовалась множественная логистическая регрессия с пошаговым выключением переменных. Результаты. Проанализировано 40 клинико-демографических, инструментальных и интраоперационных переменных. По результатам однофакторного регрессионного анализа, 6 предикторов (возраст, мужской пол, гипертензия, чрескожная транслюминальная коронарная ангиопластика в анамнезе, пересечение катетером оси дуги аорты и 2/3-й тип дуги аорты) включены в многофакторную модель. Выводы. Возраст пациента, 2/3-й тип дуги аорты и необходимость пересечения катетером оси дуги аорты являются независимыми предикторами новых ишемических очагов при каротидной ангиопластике со стентированием. Поступила в редакцию 9 января 2020 г. Исправлена 21 февраля 2020 г. Принята к печати 25 февраля 2020 г. Конфликт интересов. Авторы заявляют об отсутствии конфликта интересов. Финансирование. Исследование не имело спонсорской поддержки.

In this review, various achievements in the field of development of tissue-engineered scaffolds with the electrospinning approach were observed. Through the appropriate selection of electrospinning parameters, such as solution viscosity, the type of solvent, voltage, the distance between a tip and a collector etc., scaffolds with a high degree of porosity and pore size applicable for optimal cell infiltration can be obtained. These tissue-like materials can be produced from both synthetic and natural polymers and their mixtures. Based on the characteristics specific for the desirable tissue – vascular, bone or cardiac – materials providing the required mechanical properties, architecture, degradation kinetics and biocompatibility are selected for scaffold synthesis. In different studies, electrospun fibers were modified by adding biologically active agents or nanoparticles. This article also describes the particularities of the extracellular matrix of different tissues and approaches used for specific tissue imitation. Repopulation of the matrices with autologous cells before transplantation is the most commonly used method to improve the biocompatibility of the scaffold and the recipient.

Background. Ischaemic stroke is one of the leading causes of death and disability worldwide. Selective intracarotid cerebral hypothermia is one of the promising methods to prevent ischaemic stroke. However, currently available studies do not allow us to conclude the effectiveness of applying this method in humans and assess its effect on the system temperature.Aim. To investigate the effect of selective intracarotid cerebral hypothermia on the size of ischaemic stroke in large pigs, determining the optimal period of hypothermia and the severity of the effects of intracarotid hypothermia on the system temperature.Methods. The study was conducted on mini-pigs weighing 30–70 kg and included two stages. During the first stage, pigs were divided into two groups: control (n = 4) and intracarotid hypothermia for 3 h, exciting periods before and after reperfusion (n = 2). During the second stage, animals were also divided into two groups: hypothermia group within 1.5 h before reperfusion (n = 2) and hypothermia group within 1.5 h after reperfusion (n = 2). The technique for modelling ischaemic stroke was the same as in all groups and consisted of frontotemporal craniotomy and compression of the middle cerebral artery for 3 h. Intracarotid hypothermia was performed by infusing + 4 °C NaCl solution in the ascending pharyngeal artery. At 48 h after starting the experiment, a brain magnetic resonance imaging scan was performed to determine the size of the stroke.Results. The mean size of the stroke focusing in the control group was 10.75%, in the hypothermia group before reperfusion (10.95%) and in the hypothermia group after reperfusion (1.65%) of the volume of the cerebral hemisphere. The stroke size in the hypothermia group for 3 h could not be determined due to complications that developed in animals intraoperatively and postoperatively. The effect of intracarotid hypothermia on the systemic temperature in an animal weighing 65 kg was 0.4 °C.Conclusion. Based on the study results, a marked decrease in the focus of ischaemic stroke was found with the use of intracarotid hypothermia within 1.5 h after reperfusion. Intracarotid hypothermia was found to do not have a pronounced effect on the system temperature. Received 2 May 2020. Revised 20 May 2020. Accepted 25 May 2020. Funding: The work is supported by a grant of the Russian Foundation for Basic Research (project No. 18-415-540025). Conflict of interest: Authors declare no conflict of interest. Author contributionsConception and study design: E.I. Fartakov, V.V. Lomivorotov, E.I. Kretov, A.R. TarkovaData collection and analysis: D.U. Malaev, A.A. Boykov, A.A. Prokhorikhin, D.V. Volchenko, I.S. Zykov, P.O. SeleznevDrafting the article: E.I. Fartakov, D.U. Malaev, A.R. TarkovaCritical revision of the article: E.I. Kretov, V.V. Lomivorotov, V.I. Baystrukov, N.I. Grachev, D.S. Sergeevichev, A.M. ChernyavskiyFinal approval of the version to be published: E.I. Fartakov, V.V. Lomivorotov, D.U. Malaev, A.R. Tarkova, A.A. Boykov, A.A. Prokhorikhin, D.V. Volchenko, I.S. Zykov, P.O. Seleznev, V.I. Baystrukov, N.I. Grachev, D.S. Sergeevichev, A.M. Chernyavskiy, E.I. Kretov

Страница 36 СРАВНИТЕЛЬНОЕ ИССЛЕДОВАНИЕ СИСТЕМЫ БЕСКОНТРАСТНОЙ КТ-ДИАГНОСТИКИ ОСТРОГО ИШЕМИЧЕСКОГО ИНСУЛЬТА НА БАЗЕ НЕЙРОННЫХ СЕТЕЙ ГЛУБОКОГО ОБУЧЕНИЯ Прохорихин А.А. 1 , Байструков В.И. 1 , Бойков А.А. 1 , Малаев Д.У. 1 , Таркова А.Р. 1 , Шаяхметова С.В. 1 , Гришков А.В. 1 , Казанцев А.С. 1 , Шигаев В.В. 1 , Кох В.Н. 2 , Аветисян М.С. 2 , Умеренков Д.Е. 2 , Кретов Е

Abstract Background Pulmonary endarterectomy (PE) is the method of choice in patients with chronic thromboembolic pulmonary hypertension (CTEPH). Despite the positive effect after surgery combined with medical treatment, 10–40% of patients develop residual CTEPH. Pulmonary artery denervation (PAD) is a novel treatment in PAH with optimistic results but was not tested in patients with residual CTEPH. Objective To assess the safety and efficacy of PAD using remote magnetic navigation system in patients with residual CTEPH after PE. Methods 278 patients with CTEPH after PE were screened. 50 patients (mean age 47.6±14.3, 50% female) with a history of residual CTEPH (a resting pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance >400 dyn sec cm–5 despite medical therapy 6 months after PE) were randomized into two groups: PAD (n=25; PAD group) or medical therapy with riociguat (n=25; MED group). In both groups right heart catheterization (RHC)was performed after randomization. In the PAD group, remote magnetic navigation systemwas used to target sympathetic nerve fibers, located near bifurcation and ostia of the main brunches of right and left pulmonary arteries. This study was conducted as double-blind and sham-controlled and the primary endpoint was change in pulmonary vascular resistance (PVR) by RHC at 12 months. Secondary endpoints included 6-minute walk test (6MWT), pulmonary artery pressure, and clinical outcomes. All patients were followed for 12 months after randomization. Unpaired t-test and Fisher's exact test were used for between-group comparisons of continuous and categorical variables, respectively. A p value of less than 0.05 was considered statistically significant. Results Two patients (one in each group) developed groin hematoma which resolved without any consequences. At the end of 12 month, the PVR was significantly low in PAD group as compared with MED group (343±149 dyn sec cm–5 vs 444±145 dyn sec cm–5, respectively; mean difference −101, 95% confidence interval: −193 to −10; p=0.032). The mean, systolic and diastolic PA pressure was also reduced significantly in PAD group compared to MED group (25.8±7.3mm Hg vs 33.8±6.4 mm Hg, 46.2±14.1mm Hg vs 54.2±8.1 mm Hg,13.2±5.3mm Hg vs 20.2±4.8mm Hg; p<0.001, p=0.002, p<0.001, respectively). The PAD group demonstrated significant improvement of the 6MWT over MED group (470±84 m vs 399±116 m, respectively, p=0.031). In the PADN group 1 (4%) patient was hospitalized due to heart failure progression compared to 7 (29%) patients in MED group (p=0.049). One patient in PAD group and two patients in MED group died. Conclusions Pulmonary artery denervation in patients with residual pulmonary hypertension was safe and effective, and resulted in substantial reduction of pulmonaryvascular resistance and pulmonary artery pressure during 12 months follow up, accompanied by improved 6-minute walk test and reduced need for hospitalization. Clinical Trials Registration: NCT02745106 Acknowledgement/Funding Grant from Biosense Webster

Background. Since 1996, thrombolytic therapy with tissue plasminogen activator has traditionally been the first-line treatment for patients with ischaemic stroke. However, the results of recent randomised trials have shown the advantage of mechanical thrombectomy over thrombolytic therapy for successful revascularisation of brain arteries and improvement of clinical outcomes. Owing to the development of endovascular surgery, mechanical thrombectomy has now become an effective and safe method for treating ischaemic stroke resulting from the occlusion of large cerebral arteries.Aim. The main aim of this study was to develop a prototype for a combined transcatheter system to be used for mechanical thrombectomy.Methods. During the implementation of the project, we first analysed the data on the problems to justify the choice of standard sizes of a stent retriever and an aspiration catheter and to determine the basic set of physical–mechanical, functional and biomedical characteristics of the system. A prototype of a combined transcatheter system for mechanical thrombectomy, which comprises an aspiration catheter and a stent retriever, was manufactured. Moreover, preclinical tests were conducted to study the physical properties of the developed prototype and assess its effectiveness. Results. Data from preclinical tests showed a level of radial stiffness of the prototype that was comparable to that of a similar device on the market, satisfactory visualisation under angiography and high efficiency while performing mechanical thrombectomy in vitro and in vivo tests.Conclusions. Studies on the prototype of the combined transcatheter system for thrombectomy have shown positive results in preclinical trials.Received 5 December 2019. Revised 18 December 2019. Accepted 20 December 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Aim. The present study aimed to demonstrate the long-term outcomes after Absorb (Abbott Vascular, USA) everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in real-world patients with coronary artery disease.Methods. This trial involved the largest registry of Absorb BVS implantation in patients with coronary artery disease from Russia, and it was conducted between 2014 and 2018 (n = 500). Safety and efficacy parameters (target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation; major adverse cardiac and cardiovascular events, defined as a composite of cardiac death, myocardial infarction, target vessel revascularisation and stroke, stent thrombosis according to the Academic Research Consortium definition) were assessed over a period of 2 years after the index procedure. Results. Lesion treatment success was achieved in 98.51% (n = 594) of patients. In the 2 years after Absorb BVS implantation, long-term outcomes were assessed via phone calls. Only 9.8% (n = 49) of patients were lost to follow-up. The rates of target vessel failure and major adverse cardiac and cerebrovascular events were 11.6% (n = 58) and 12.6% (n = 63), respectively. Definite/probable stent thrombosis was observed in 3.2% (n = 16) of patients. Conclusion. Using an optimal implantation technique during Absorb BVS implantation in routine clinical practice leads to a high level of lesion treatment success. However, despite this, Absorb BVS use is associated with an increased risk of device-related adverse events, particularly stent thrombosis. Absorb BVS use in long and bifurcated lesions and BVS implantation in the distal segment of the coronary artery are independent predictors of stent thrombosis. In addition, Absorb BVS use in patients with a high functional class of angina and heart failure, multivessel coronary artery disease as well as BVS implantation in the distal segment of the coronary artery are independent predictors of device-related adverse events.Received 22 July 2019. Revised 1 October 2019. Accepted 14 October 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Актуальность. С 1996 г. тромболитическая терапия с тканевым активатором плазминогена традиционно была первой линией лечения пациентов с ишемическим инсультом. Однако результаты последних рандомизированных исследований показали преимущество механической тромбэктомии над тромболитической терапией как в реваскуляризации артерий головного мозга, так и в улучшении клинических результатов. Благодаря развитию эндоваскулярной хирургии механическая тромбэкстракция является эффективным и безопасным методом лечения ишемического инсульта, возникающего вследствие окклюзии крупных церебральных артерий. Цель. Разработка прототипа комбинированной транскатетерной системы для внутрисосудистой тромбэктомии. Методы. Проведен анализ данных по проблематике для обоснования выбора типоразмеров стента-ретривера и аспирационного катетера, а также для определения основного набора физико-механических, функциональных и медико-биологических характеристик системы. Изготовлен прототип комбинированной транскатетерной системы для механической тромбэктомии из церебральных сосудов, состоящий из аспирационного катетера и стент-ретривера. Изучены физические свойства прототипа, оценена его эффективность. Результаты. Доклинические испытания показали сопоставимую радиальную жесткость опытного образца с аналогичным устройством на рынке, удовлетворительную визуализацию рентгеноконтрастных меток под ангиографической установкой, а также высокую эффективность тромбэктомии в испытаниях in vitro и in vivo. Выводы. Прототип комбинированной транскатетерной системы для тромбэктомии продемонстрировал положительные результаты доклинических испытаний.

Despite the development of modern medical technologies, cerebrovascular disease remains a major health and social issue. Among all the cases of ischemic stroke, approximately 20% are attributable to stenotic lesions in the carotid artery. The main drawback of carotid stenting is the risk of embolic complications during the procedure. To resolve this problem, various devices that protect against embolism have been developed. In this clinical case, we describe the ability to minimize the risk of operative stroke through a combined application of the distal and proximal protection systems in carotid stenting.In our patient, a 65-year-old woman, angiography of the carotid arteries revealed an ulcerated atherosclerotic plaque of the right internal carotid artery, with stenosis of the lumen of up to 95%. Considering the high risk of distal embolism, the Mo MaUltra (Italy) proximal protection system was used. When evaluating the installation of the Mo MaUltra system, the preserved blood flow through the superior thyroid artery and, therefore, the antegrade blood flow in the internal carotid artery was revealed. Considering the identified risk and the anatomy of the plaque surface, we decided on the additional use of the distal SpiderFX (USA) protection device.The combined use of proximal protection system and distal protective device for carotid stenting is technically possible and may reduce the risk of embolic complications.Received 23 January 2019. Revised 18 March 2019. Published 23 April 2019.Informed consent: The patient’s informed consent to use the records for medical purposes is obtained.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Цель. Представить отдаленные результаты применения эверолимус-покрытого биодеградируемого сосудистого каркаса (БСК) Absorb (Abbott Vascular, США) у пациентов с ишемической болезнью сердца и показаниями к чрескожной коронарной реваскуляризации. Методы. Данное исследование является крупнейшим в России одноцентровым регистром имплантации БСК Absorb у пациентов с ишемической болезнью сердца (n = 500). Исследование проводилось в 2014–2018 гг. Параметры безопасности и эффективности (несостоятельность целевой артерии, определяемая как кардиальная смерть, инфаркт миокарда в бассейне целевой артерии, реваскуляризация целевой артерии по клиническим показаниям; серьезные неблагоприятные кардиальные и цереброваскулярные события, определяемые как кардиальная смерть, инфаркт миокарда, инсульт, повторная реваскуляризация целевой артерии; тромбоз стента согласно критериям Academic Research Consortium) определялись на протяжении двухлетнего послеоперационного периода. Результаты. Успех лечения поражения наблюдался в 98,51% (n = 594) случаев. Через 2 года послеоперационного наблюдения посредством телефонного опроса проведена оценка отдаленных результатов. Потеря контакта составила 9,8% (n = 49). За время наблюдения частота несостоятельности целевой артерии и серьезных неблагоприятных кардиальных и цереброваскулярных событий составила 11,6% (n = 58) и 12,6% (n = 63) соответственно. Определенный/вероятный тромбоз стента наблюдался в 3,2% (n = 16) случаев. Выводы. Техника оптимальной имплантации при БСК Absorb в условиях рутинной клинической практики ведет к высокой частоте успеха лечения поражения. Однако, несмотря на успешность лечения, применение биодеградируемого каркаса Absorb связано с повышенным риском неблагоприятных событий, в особенности тромбоза каркаса. Применение БСК Absorb при протяженных и бифуркационных поражениях, имплантация БСК в поражения, расположенные в дистальном коронарном русле, являются независимыми предикторами тромбоза устройства. Использование БСК Absorb у пациентов с высокими функциональными классами стенокардии и хронической сердечной недостаточности, фибрилляцией предсердий в анамнезе, многососудистым поражением коронарных артерий и имплантация БСК в дистальные сегменты коронарных артерий являются независимыми предикторами устройство-ассоциированных осложнений. Поступила в редакцию 22 июля 2019 г. Исправлена 1 октября 2019 г. Принята к печати 14 октября 2019 г. Конфликт интересов Авторы заявляют об отсутствии конфликта интересов. Финансирование Исследование не имело спонсорской поддержки.

Background. Metallic stent implantation is associated with an increased risk of adverse events, such as prolonged endothelial dysfunction, constant traumatisation of the vessel wall, chronic local inflammation and thrombosis. Thus, the development and manufacturing of bioresorbable stents, which maintain the required support during the vessel healing period and completely dissolve without any side effects, is highly relevant. At present, magnesium alloys are regarded the most applicable for this purpose due to their low corrosion resistance and high biocompatibility.Aim. To assess the cytotoxicity of different magnesium alloys in vitro.Methods. Using strain tempering, seven samples with different yield stress levels were produced: sample 1, MgZnZr (ZK60) 310 МPа; sample 2, MgZnCa (ZX10) 60 МPа; sample 3, MgZnCa (ZX40) 130 МPа; sample 4, MgYZn (WZ31) 300 МPа; sample 5, MgYZn (WZ31) 275 МPа; sample 6, MgYZn (WZ20) 340 МPа and sample 7, MgZnZr (ZK60) 180 МPа. The samples were incubated in a culture medium to obtain the extract, which was further tested on immortalised human fibroblasts. The cytotoxicity of the obtained extract was assessed using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay, flow cytometry, optical microscopy and pH test.Results. In MTT assay, sample 7 was significantly cytotoxic (mean cell survival: 48% [2% ± 1%]), whereas sample 5 was slightly cytotoxic (mean cell survival: 81% [4% ± 14%]). In optical microscopy, the same samples showed the lowest cell density. In flow cytometry, the number of necrotic cells significantly increased in sample 7 (8.25%) and only slightly increased in samples 1 and 5 (3.449% and 3.626%, respectively). Furthermore, samples 5 and 7 showed the highest medium pH.Conclusion. The composition and strain tempering method magnesium alloys are directly correlated with the degree of cell necrosis, change in morphology and medium pH in vitro.Received 7 June 2019. Revised 28 October 2019. Accepted 6 November 2019.Funding: The work is supported by the Ministry of Science of Russian Federation (project RFMEFI58317X0070).Conflict of interest: Authors declare no conflict of interest.