Randomized Clinical Trial of Hybrid vs. Surgical vs. Percutaneous Multivessel Coronary Revascularization: 5­year Follow-up of HREVS Trial.

Aim      To evaluate 5-year results of the HREVS (Hybrid REvascularization Versus Standarts) study.Material and methods  The study included 155 consecutive patients with multivessel coronary artery disease who were randomized into 3 groups: coronary artery bypass grafting (CABG) (n=50), hybrid coronary revascularization (HCR) (n=52) and percutaneous coronary intervention (PCI) (n=53) according to the consensus of the cardiology team on the technical and clinical feasibility of each of the three coronary revascularization strategies. The primary endpoint of the study was residual ischemia 12 months after revascularization according to data of single-photon emission computed tomography (SPECT). Secondary endpoints were major adverse cardiac and cerebrovascular events (MACCE) over 5 years of follow-up, which included all-cause death, myocardial infarction, stroke, and clinically determined repeat myocardial revascularization.Results Baseline characteristics of patients did not differ between study groups. Median residual ischemia determined by SPECT data after 12 months was not statistically significantly different in the CABG, HCR and PCI groups: 6.7 [4.6; 8.8]%, 6.4 [4.3; 8.5]% and 7.9 [5.9; 9.8]%, respectively (p=0.45). Mean follow-up period was 76.5 months (at least 60 months). There were no statistically significant differences in all-cause mortality between the CABG, HCR and PCI groups, 10.6, 12.8 and 8.2 %, respectively (p=0.23). Statistically significant differences between the groups of CABG, HCR and PCI in the incidence of myocardial infarction (12.8; 8.5 and 16.3 %; p=0.12), stroke (4.2; 6.4 and 10.2 % ; p=0.13), repeat revascularization for clinical indications (23.4; 23.4 and 34.7 %; p=0.11) were not observed either. However, the cumulative 5-year MACCE value was similar in the HCR group and the CABG group but significantly lower than in the PCI group (51.1, 51.1 and 69.4 %, respectively; p = 0.03).Conclusion      HCR that combines advantages of PCI and CABG is a promising strategy for coronary revascularization in multivessel coronary artery disease. HCR demonstrates satisfactory long-term results comparable to those of CABG but superior to PCI. To confirm the safety and efficacy of HCR, a large multicenter study is required that would have a sufficient power to evaluate clinical endpoints.

[Predictors of Coronary Plaque Vulnerability in Patients with Stable Coronary Artery Disease].

Aim      To identify new predictors for vulnerability of atherosclerotic coronary plaques in patients with stable ischemic heart disease (sIHD).Material and methods  This prospective, single-center study included 58 patients with sIHD. Unstable plaques were detected with virtual histology intravascular ultrasound of proximal and medium segments of a coronary artery without significant lesions according to coronarography data. Indexes of inflammation, dyslipidemia and carbohydrate metabolism were considered as candidate predictors for coronary plaque vulnerability.Results In 56 coronary arteries, 58 plaques were detected, 12 of which (20.7 %) were unstable. Vulnerable plaques differed morphologically from stable ones by a greater size of the necrotic core (35.1±8.5 % vs. 24.0±13.2 %; р=0.008), calcified nodules (2.0 [1.0; 5.0] % vs. 1.0 [0; 2.0] %; р=0.006), and a lower content of fibrous components (54.9±10.2 % vs. 66.4±15.8 %; р=0.02). In addition, vulnerable plaques more frequently narrowed the arterial lumen by >70 % of the lumen area (33.3 % vs. 2.2 %; р=0.0006). Correlation analysis showed a negative correlation between the level of high-density lipoproteins (HDL) and calcium volume (r= -0.4104; р=0.023); a positive correlation between the blood glucose level as determined by the oral glucose tolerance test and the lipid component (r=0.48198; р=0.033); and a negative correlation between the apolipoprotein A level and the calcium volume (r= -0.4297; р=0.008).Conclusion      The study demonstrated a high prevalence of vulnerable plaques in nontarget coronary arteries in patients with sIHD. In this process, dyslipidemia indexes (LDL, apolipoproteins A) correlate with the calcium volume whereas blood glucose, as measured in the oral glucose tolerance test, correlates with the lipid component of coronary plaque.

[Predictors of acute coronary syndrome in patients with ischaemic heart disease]. / Prediktory ostrogo koronarnogo sindroma u patsientov s ishemicheskoi bolezn'iu serdtsa.

Acute coronary syndrome has for a long time been giving no way of decreasing mortality related to ischaemic heart disease. The primary cause of acute coronary syndrome in the majority of cases is rupture of an unstable atherosclerotic plaque in the coronary artery followed by thrombosis thereof. The main missions of modern cardiology include: assessment of the risk of acute coronary syndrome, identification of predictors of adverse events, and working-out of measures aimed at prevention and optimal management of patients with ischaemic heart disease. This article deals with clinical and morphological factors associated with destabilization of coronary plaques, their rupture, and the development of an acute coronary event.

[Vulnerable atherosclerotic plaques of coronary arteries in patients with stable coronary artery disease: 12-months follow-up].

RELEVANCE: A key objective of modern cardiology is the assessment of acute coronary syndrome (ACS) risk in patients with coronary artery disease (CAD) to develop preventive measures and choose optimal treatment strategies. OBJECTIVE: Detect vulnerable plaques of non-target coronary arteries in patients with stable CAD during routine percutaneous coronary intervention using virtual-histology intravascular ultrasound (VH-IVUS) and view their morphology over time. MATERIALS AND METHODS:  The prospective observational cohort study included 58 patients with stable CAD. After stenting of a target vessel, VH-IVUS was carried out in proximal and middle segments (6-8 cm) of a non-target coronary artery with no significant stenosis according to coronary angiography. Twelve months later, all patients underwent coronary angiography with re-IVUS of previously detected lesions. Death, myocardial infarction, rehospitalization, and unplanned myocardial revascularization due to vulnerable plaques were the endpoints of the study. RESULTS: IVUS with virtual histology revealed 58 lesions of non-target coronary arteries in 56 (96.5 %) patients. Two patients had no lesions in non-target coronary arteries. A large necrotic core with thin cap (thin-cap fibroatheroma) was detected in 12 (20.7 %) plaques, six of which had additional ACS risk criteria (stenosis area >70 % and / or lumen area <4 mm2). Within the 12­month follow-up period, three patients (one with a vulnerable plaque in IVUS) were hospitalized with a clinical picture of ACS. One cardiac death was registered in a patient with the IVUS vulnerable plaque. 7 of 12 vulnerable plaques stabilized in 12 months. CONCLUSION: 1) The data presented indicate a high rate (20.7 %) of vulnerable plaques of non-target coronary arteries in patients with stable CAD who underwent stenting; 2) Two (16.6 %) patients with vulnerable plaques reached endpoints (death and rehospitalization) within the 12­month follow-up period; 3) An analysis of atherosclerotic plaques in non-target coronary arteries over time showed that vulnerable plaques stabilized and did not cause ACS in more than half of cases (7 of 12); 4) Plaques that were not vulnerable according to IVUS were not likely to destabilize within the 12­month follow-up period.

[Immediate results of three methods of surgical myocardial revascularization in multivessel lesion of the coronary bed]. / Neposredstvennye rezul'taty trekh metodov khirurgicheskoi revaskuliarizatsii miokarda pri mnogososudistom porazhenii koronarnogo rusla.

INTRODUCTION: Percutaneous coronary intervention (PTI) and coronary artery bypass grafting (CABG) are currently the most commonly used techniques of myocardial revascularization. However, each of the methods has its own advantages and disadvantages. The creation of hybrid coronary revascularization (HCR) was based on an attempt to combine the benefits of CABG and PTI. AIM: The study was aimed at assessing the immediate results of three methods of surgical myocardial revascularization in patients with multivessel lesions of the coronary bed in stable ischaemic heart disease. PATIENTS AND METHODS: The study enrolled a total of 155 patients randomized into three groups of myocardial revascularization: HCR, CABG and PTI. In the HCR group, the first stage consisted in minimally invasive myocardial revascularization with the anterior descending artery (ADA) followed by PTI (within 1-3 days) with implantation of drug-eluting second-generation stents Xience to other coronary vessels. In the CABG and PTI groups we performed CABG and PTI, respectively, using the Xience stents. In all three groups we assessed the procedural success, frequency of major adverse cardiovascular events and bleeding. RESULTS: Full myocardial revascularization was achieved in all three groups in more than 90% of cases. No statistically significant differences in either the procedural success rate or frequency of major adverse cardiovascular events between the CABG, PTI and HCR were revealed. The PTI group was characterized by the lowest frequency of bleeding, need for rehabilitation, and length of hospital stay. CONCLUSION: Hybrid revascularization with the use of minimally invasive direct myocardial revascularization with the ADA followed by PTI with second-generation drug-eluting stents to other coronary arteries is a method of choice in treatment of patients with multivessel lesions of coronary arteries.

[Transcatheter aortic valve implantation under extracorporeal membrane oxygenation]. / Transkateternaia implantatsiia aortal'nogo klapana v usloviiakh ékstrakorporal'noi membrannoi oksigenatsii.

Transcatheter aortic valve implantation (TAVI) has become the standard treatment for advanced age and high risk patients with severe aortic stenosis. The incidence of life-threatening complications during TAVI has significantly decreased over the last decade due to advanced current surgical experience. However, there is a risk of perioperative life-threatening complications which can require emergency hemodynamic support. Veno-arterial extracorporeal membrane oxygenation (ECMO) may represent an effective strategy for immediate hemodynamic stabilization until further treatment of the underlying complication. It is presented case report of TAVI under ECMO performed at the Kemerovo Research Institute for Complex Issues of Cardiovascular Diseases. Emergency ECMO represents a feasible strategy for stabilization until further treatment of life-threatening complications during TAVI.

[Evolution of transcatheter aortic valve implantation: from planning to robotic systems]. / Évoliutsiia transkateternoi implantatsii aortal'nogo klapana.

Since its introduction in 2002, transcatheter aortic valve implantation (TAVI) has evolved dramatically and is now standard of care for intermediate risk patients with aortic stenosis. The development of innovative transcatheter heart valves and refinement of technical skills have contributed to the decrease in complication rates associated with TAVI. Increased experience, smaller sheaths, rigorous pre-procedural planning and improved vascular closing techniques have resulted in markedly lower rates of vascular complications. The next step was the simplification of the procedure, which contributed to a further decrease in complications, reduced procedural time, and shorter hospital stay. Change-over from general anaesthesia to conscious sedation, refusal from predilatation, and use of the radial approach instead of the contralateral femoral approach are all instrumental in achieving optimal results. Prospects for development include visual assist systems and robotic systems that can potentially optimize the transcatheter aortic valve implantation process, improve safety and effectiveness of the procedure.

Bioresorbable Vascular Scaffold Compared With Minimally Invasive Bypass Surgery for the Left Anterior Descending Coronary Artery Disease: 12-Month Follow up.

THE AIM: Evaluates long-term clinical outcomes of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) versus minimally invasive direct coronary artery bypass (MIDCAB) surgery for the treatment of left anterior descending (LAD) lesions. METHODS AND RESULTS: In this single-center study were included 130 patients with stable angina and significant (≥ 70 %) LAD disease. Patients were randomly assigned in a 1:1 ratio to PCI with everolimus-eluting BVS (n=65) or MIDCAB (n=65). The primary end-point was major adverse cerebro-cardiovascular events (MACCE) and secondary was scaffold (graft) thrombosis at 1 year. The groups of patients were comparable for all baseline demographic, clinical and angiographic parameters. MACCE at 12 month occurred in 9.2 % of patients in the BVS group and in 4.6 % of patients in the MIDCAB group (p=0.3). There was no significant difference between the groups in rates of all cause death (1.5 % vs 1.5 %, p=1.0), myocardial infarction (3.1 % vs. 6.1 %, p=0.4), any revascularization (1.5 % vs. 6.1 %, p=0.1) and scaffold (graft) thrombosis (1.5 % vs. 1.5 %, p=1.00). CONCLUSION: At 12-month follow up, there was no significant difference in the rate of MACCE between PCI by BVS and MIDCAB in patients with isolated LAD lesions.

[Transcutaneous coronary intervention with the use of extracorporeal membrane oxygenation in patients with acute coronary syndrome]. / Chreskozhnoe koronarnoe vmeshatel'stvo s primeneniem ékstrakorporal'noi membrannoi oksigenatsii u bol'nykh s ostrym koronarnym sindromom.

Analysed herein are the in-hospital and remote (12 months) results of transcutaneous coronary interventions (TCI) carried out in patients with non-ST elevation acute coronary syndrome (nSTE-ACS) and multivessel coronary artery disease with the use of extracorporeal membrane oxygenation (ECMO). From 2013 to 2015, the study included a total of 18 patients with nSTE-ACS and multivessel coronary artery disease who had been denied "open" surgical myocardial revascularization. The mean values (scores) of the scales in the group were as follows: GRACE - 119.7±67.6, SYNTAX Score - 33.5±8.1, Euroscore II - 5.2±21.9. The ejection fraction was averagely moderately low - 49.3±19.4%. During the in-hospital stay of the patients and 12 months after TCI we assessed the major adverse cardiovascular events (MACE): death, myocardial infarction, acute cerebral circulation impairment/transitory ischaemic attack, repeat revascularization of the target vessel - both as separate parameters and in a composite form. Additionally, we analysed perioperative and in-hospital complications, their structure, the volume of replacement therapy with blood components and the length of hospital stay. During the in-hospital period and at 12 months of follow up, the composite number of cases of adverse cardiovascular events amounted to 1 (5.5%) and 3 (16.5%), respectively. One patient died during in-hospital treatment and one more lethal outcome was registered by 12 months of follow up; hence, the mortality rate amounted to 1 (5.5%) and 2 (11%) cases, respectively. Stroke was observed in 1 (5.5%) patient only during the in-hospital period. No repeat revascularisation of the target vessel was performed. By the end of the hospital stay, BARC type 3-5 haemorrhagic complications were observed in 50% of patients. The in-hospital and remote (12 months) results of high-risk TCI with ECMO support in patients with nSTE-ACS and multivessel coronary artery disease, who had been denied surgical revascularization demonstrated an acceptable level of unfavourable outcomes. This approach may be regarded as a method alternative to revascularization and used in an utterly severe cohort of patients.

[Outcomes of Various Revascularisation Strategies in the Elderly STEMI Patients With Multi-Vessel Coronary Pathology].

AIM: to assess safety and efficacy of single stage complete revascularization by multivessel stenting as primary percutaneous coronary intervention (pPCI) in elderly and middle aged patients with acute ST-elevation myocardial infarction (STEMI). MATERIAL AND METHODS: We included in this analysis data on 327 of 1690 STEMI patients who had undergone pPCI from 2009 to 2013. Age of 103 patients was more or equal 65 and of 224 less or equal 64 years. Multivessel stenting (MS) during pPCI was carried out in 26 and 65, while strategy of staged revascularization (SR) was implemented in 77 and 129 individuals among older and younger patients, respectively. During follow-up for 12 months we registered deaths, myocardial infarctions, and unplanned target vessel revascularizations. RESULTS: In each age group ( more or equal 65 and less or equal 64 years) there were no significant differences in clinical and demographic characteristics between subgroups of patients subjected to MS and SR. MS appeared to be safe and effective irrespective of age. Mortality during first 30-days was higher among patients aged more or equal 65 years. However, within each age group there were no significant differences in 1 year results between MS and SR subgroups.

[Long-term results of different approaches to revascularization in non-ST-segment elevation acute coronary syndrome and multiple coronary atherosclerosis]. / Otdalennye rezul'taty razlichnykh podkhodov k revaskuliarizatsii pri ostrom koronarnom sindrome bez pod''ema segmenta ST i mnozhestvennom koronarnom ateroskleroze.

AIM: To assess the long-term results of different approaches to treating patients with non-ST-segment elevation acute coronary syndrome (NSTE ACS) and multivessel coronary artery disease (MVCAD). SUBJECTS AND METHODS: A total of 150 patients with NSTE ACS, in whom coronary angiography revealed MVCAD, were examined. The patients were divided into 3 groups according to the selected treatment policy: 1) percutaneous coronary intervention (PCI) (n=91 (60.6%)); 2) coronary artery bypass grafting (CABG) (n=40 (26.6%)); and 3) only medical treatment (n=9 (6%)). The mean follow-up was 27.6±3.5 months. RESULTS: The medical treatment policy in this patient sample demonstrates the worst results, with the majority of cardiovascular events developing in the hospital period. PCI in patients with NSTE ACS and multiple coronary atherosclerosis has a number of objective limitations in this patient sample, leading to suboptimal treatment outcome. CONCLUSION: The use of CABG or PCI as a myocardial revascularization technique in patients with NSTE ACS and MVCAD is characterized by a comparable satisfactory survival in the hospital and long-term follow-up periods. 12% of patients do not receive revascularization due to the extremely high risk from any of coronary blood restoring methods, which results in very many deaths largely occurring during the hospital period.

[In-hospital Outcomes and Complications of Percutaneous Coronary Interventions in Acute ST-Elevation Myocardial Infarction in Different Age Groups].

AIM: to assess early (in-hospital) results of percutaneous coronary intervention (PCI) for ST-elevation (STE) myocardial infarction (MI) in different age groups. MATERIALS AND METHODS: We enrolled in this study 356 patients with STEMI who underwent PCI within 24 hours of the disease during 1 year (2012). According to age all patients were divided into 2 groups: "young" ( less or equal 70 years) and "older" (>70 years). RESULTS: Compared with young in older group there were more patients with renal (53.84 vs. 19.78%) and myocardial (23.07 vs. 6.83%, =0.0000) dysfunction, hypertension (97.43 vs. 83.81% =0.0018), history of MI (19.23 vs. 10.43%, =0,3736), and acute heart failure at admission (32.04 vs. 13.95%, =0.0003), and less smokers (10.25 vs. 34.53%). Hospital mortality in older group was higher (8.97 vs. 1.43%, =0.0007) despite effective PCI. Rate of hemorrhagic complications (major bleedings+hemotransfusions) was also higher in older group (5.12 vs. 0.71%, =0.0077). CONCLUSION: Compared with younger older STEMI patients were characterized by more severe initial clinical condition and worse early results of primary PCI with higher mortality and rate of hemorrhagic complications. Thus the problem of improvement of management of this group of patients during hospitalization remains to be actual.

[THE PROBLEM OF HEMORRHAGIC COMPLICATIONS OF PERCUTANEOUS CORONARY INTERVENTIONS IN ELDERLY PATIENTS WITH ACUTE CORONARY SYNDROME].

The authors review the literature on the frequency of hemorrhagic complications of percutaneous coronary interventions with special reference to the patients of advanced age.

New Tissue-Engineered Vascular Matrix Based on Regenerated Silk Fibroin: in vitro Study.

The aim of the study was to make a vascular patch based on regenerated silk fibroin (SF) and study its physical and mechanical characteristics, biocompatibility and matrix properties in comparison with polyhydroxybutyrate/valerate/polycaprolactone with incorporated vascular endothelial growth factor (PHBV/PCL/VEGF) and commercial bovine xenopericardium (XP) flap in experiments in vitro. Materials and Methods: Tissue-engineered matrices were produced by electrospinning. The surface structure, physical and mechanical characteristics, hemocompatibility (erythrocyte hemolysis, aggregation, adhesion and activation of platelets after contact with the material) and matrix properties of vascular patches (adhesion, viability, metabolic activity of EA.hy926 cells on the material) were studied. Results: The surface of SF-based matrices and PHBV/PCL/VEGF-based tissue engineered patches had a porous and fibrous structure compared to a denser and more uniform XP flap. The physical and mechanical characteristics of SF matrices were close to those of native vessels. Along with this, tissue-engineered patches demonstrated high hemocompatible properties, which do not differ from those for commercial XP flap. Adhesion, viability, and metabolic activity of EA.hy926 endothelial cells also corresponded to the previously developed PHBV/PCL/VEGF matrix and XP flap, which indicates the nontoxicity and biocompatibility of SF matrices. Conclusion: Matrices produced from regenerated SF demonstrated satisfactory results, comparable to those for PHBV/PCL/VEGF and commercial XP flap, and in the case of platelet adhesion and activation, they outperformed these patches. In total, SF can be defined as material having sufficient biological compatibility, which makes it possible to consider a tissue-engineered matrix made from it as promising for implantation into the vascular wall.

Mechanism of Vascular Injury in Transcatheter Aortic Valve Replacement.

The aim of the study was to determine the potential mechanism of vascular complications due to "catheter-vascular wall" interaction in transcatheter aortic valve replacement using experimental and numerical analysis. MATERIALS AND METHODS: A series of full-scale bench tests and numerical simulations were carried out using the CoreValve commercial transfemoral delivery system for aortic valve bioprosthesis (Medtronic Inc., USA). Full-scale tests were carried out using a phantom of the vascular system (a polymeric silicone model of Transcatheter Aortic Valve; Trandomed 3D Inc., China) with simulation of all stages of delivery system movement along the vascular bed. They involved introduction into the common femoral artery, movement along the abdominal and thoracic parts of the aorta, the aortic arch, and positioning the system to the implantation site. The force arising from the passage of the delivery system was assessed using sensors of a Z50 universal testing machine (Zwick/Roell, Germany). Numerical simulation of transcatheter valve replacement procedure was carried out in a similar way with allowance for the patient-specific anatomy of the recipient's aorta using the finite element method in the Abaqus/CAE environment (Dassault Systèmes, France). RESULTS: It was found that in the process of the delivery system passing through the vascular system, there occurred force fluctuations associated with catheter bending and its interaction with the aortic wall in the region of its arch. For example, in the initial straight portions, the pushing force was 3.8-7.9 N; the force increased to the maximum (11.1 and 14.4 N with and without the prosthesis) with bending of the distal portion of the catheter. A similar increase was observed when performing numerical simulation with high-quality graphic visualization of stress on the "spots" of contact between the catheter and the vascular wall with an increase in stress to 0.8 MPa. CONCLUSION: Numerical and full-scale bench tests prove the significant effect of the properties of delivery system catheter for transcatheter aortic valve replacement on the interaction with the aortic walls.