Background. The 6-minute walk test (6MWT) is a widely used instrument for assessing the patient’s functional status and selecting parameters of physical training. The distance covered in 6 minutes is the main result of 6MWT, however, this indicator is influenced by many factors: age, gender, weight, height of the patient, the methodology of the test. Objective. To assess the influence of various pre-test instructions on the distance value covered during the 6MWT by schoolchildren with congenital heart defects. Material and methods. 67 patients with corrected congenital heart defects and congestive heart failure aged 12.8 (7–16) years were included, 59.5 % were boys. Everyone underwent two 6MWT with different instructions for implementation. Test 1: the patient was given the goal to walk the maximum possible distance in 6 minutes (the “Further” test — FT). Test 2: The patient was instructed to walk as fast as possible in order to cover the maximum possible distance in 6 minutes (the “Faster and Further” test — FFT). The sequence of tests was random. Results. The distance covered in FFT was greater than in FT in 79.2 % of the surveyed, amounting to 505 [439; 570] meters and 580 [507; 648] meters (p < 0.0001) or 69 [57; 79] % and 79 [70; 87] % of the required values (p < 0.0001) respectively for FT and FFT tests. The heart rate measured in the first 10 seconds after physical activity in 89.6 % of patients was higher in FFT — 126 [110–139] BPM, in FT — 104 [92–120] BPM (p < 0.0001) or 60.2 [53.2; 67.5] % and 50.3 [44.5; 56.7] % of the maximum calculated heart rate (220-age). The increase in heart rate was 40 [25; 48] BPM and 15 [10; 28] BPM or 31.1 [20.1; 41.7] % and 12.9 % [8.8; 22.8] of the heart rate reserve, respectively, in the FT and FFT groups, p < 0.0001. Conclusion. The instruction to walk “as fast as possible in order to cover as much distance as possible” increases the distance of the 6MWT by increasing the intensity of physical effort without reducing the safety of the study. This increases the informativeness of the test in assessment the patient’s functional status and the formation of a physical rehabilitation program.
Background Women with chronic coronary disease have more frequent angina and worse health status than men, despite having less coronary artery disease (CAD). We examined whether perceived stress and depressive symptoms mediate sex differences in angina, and whether this relationship differs in the setting of obstructive CAD or ischemia with no obstructive coronary artery disease (INOCA). Methods We analyzed the association between sex, stress (Perceived Stress Scale‐4) and depressive symptoms (Patient Health Questionnaire‐8) on angina‐related health status (Seattle Angina Questionnaire [SAQ]) at enrollment in the ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) trial and CIAO‐ISCHEMIA (Changes in Ischemia and Angina Over 1 Year Among ISCHEMIA Trial Screen Failures With No Obstructive CAD on Coronary CT [Computed Tomography] Angiography) ancillary study. Results Scores for the SAQ, Perceived Stress Scale‐4, and Patient Health Questionnaire‐8 were available in 1626 participants (N=1439 CAD and N=187 INOCA). Women had lower (worse) SAQ‐7 summary scores than men in both CAD and INOCA cohorts (CAD: median 76 [25th, 75th percentiles 60, 90] versus 83 [70, 96], P<0.001; INOCA: 80 [64,89] versus 85 [75, 93], P=0.012). Higher stress and depressive symptoms were associated with worse angina in both cohorts. Female sex, Perceived Stress Scale‐4 score, and Patient Health Questionnaire‐8 score were each independently associated with lower SAQ summary score, but CAD versus INOCA cohort was not. There was no interaction between sex and stress (−0.39 [95% CI, –1.01 to 0.23]) or sex and depression (−0.00 [95% CI, –0.53 to 0.53]) on SAQ summary score. Conclusions High stress and depressive symptoms were independently associated with worse angina and poorer health status, without interaction with sex with or without obstructive CAD. Factors other than stress or depression contribute to worse health status in women with obstructive CAD or INOCA. Registration URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02347215, NCT01471522.
Congenital heart defects (CHD) are the most common form of congenital malformations in children. Due to early diagnosis, rapid development of cardiac surgery technologies as well as successes in the care of severe patients after surgical correction of CHD, the survival and life expectancy of patients with CHD have significantly increased over the past decades. All this has led to the emergence of new population of patients with severe CHD and unique cardiac hemodynamics due to palliative intervention or multi-stage correction with large amount of exposure. Such patients have specific functional capabilities, special cardiopulmonary performance as well as the risk of serious adverse events (heart failure, life-threatening cardiac arrhythmias, sudden cardiac death and others). The review presents generalized current understanding about the possibilities of a cardiorespiratory test in children with various CHD.
BACKGROUND: ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) did not find an overall reduction in cardiovascular events with an initial invasive versus conservative management strategy in chronic coronary disease; however, there were conservative strategy participants who underwent invasive coronary angiography early postrandomization (within 6 months). Identifying factors associated with angiography in conservative strategy participants will inform clinical decision-making in patients with chronic coronary disease. METHODS: Factors independently associated with angiography performed within 6 months of randomization were identified using Fine and Gray proportional subdistribution hazard models, including demographics, region of randomization, medical history, risk factor control, symptoms, ischemia severity, coronary anatomy based on protocol-mandated coronary computed tomography angiography, and medication use. RESULTS: Among 2591 conservative strategy participants, angiography within 6 months of randomization occurred in 8.7% (4.7% for a suspected primary end point event, 1.6% for persistent symptoms, and 2.6% due to protocol nonadherence) and was associated with the following baseline characteristics: enrollment in Europe versus Asia (hazard ratio [HR], 1.81 [95% CI, 1.14–2.86]), daily and weekly versus no angina (HR, 5.97 [95% CI, 2.78–12.86] and 2.63 [95% CI, 1.51–4.58], respectively), poor to fair versus good to excellent health status (HR, 2.02 [95% CI, 1.23–3.32]) assessed with Seattle Angina Questionnaire, and new/more frequent angina prerandomization (HR, 1.80 [95% CI, 1.34–2.40]). Baseline low-density lipoprotein cholesterol <70 mg/dL was associated with a lower risk of angiography (HR, 0.65 [95% CI, 0.46–0.91) but not baseline ischemia severity nor the presence of multivessel or proximal left anterior descending artery stenosis >70% on coronary computed tomography angiography. CONCLUSIONS: Among ISCHEMIA participants randomized to the conservative strategy, angiography within 6 months of randomization was performed in <10% of patients. It was associated with frequent or increasing baseline angina and poor quality of life but not with objective markers of disease severity. Well-controlled baseline low-density lipoprotein cholesterol was associated with a reduced likelihood of angiography. These findings point to the importance of a comprehensive assessment of symptoms and a review of guideline-directed medical therapy goals when deciding the initial treatment strategy for chronic coronary disease. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01471522.
Postmastectomy syndrome (PMS) is a complex neurovascular set of symptoms that develops in most patients after breast cancer (BC) treatment and significantly reduces the quality of life. One of the potential mechanisms of its occurrence is considered to be an endothelial dysfunction. The possible method of reducing manifestation of endothelial dysfunction is systematic aerobic dynamic training. OBJECTIVE:To evaluate the influence of 12-week aerobic dynamic training program of moderate intensity on the endothelial dysfunction laboratory markers and life quality in patients with PMS. MATERIAL AND METHODS:Single-center prospective randomized trial included 40 patients with PMS divided into study (20 patients) and comparative (20 patients) groups, as well as 20 healthy female volunteers. The expression level of soluble intercellular adhesion molecule-1 (ICAM-1) and platelet endothelial cell adhesion molecule-1 (PECAM-1) were evaluated in all participants at baseline by enzyme-linked immunosorbent assay method, and additionally psychological and physical component of health by SF-36 questionnaire were assessed in patients with PMS. Patients of study group received a course of 12-week partially controlled aerobic dynamic training of moderate intensity lasting 45 minutes with frequency equal 5 times per week. Patients with PMS were re-evaluated for ICAM-1 and PECAM-1, as well as for life quality. RESULTS:The group of patients with PMS after BC treatment had increased level of ICAM-1 in long-term period, that may indicate endothelial dysfunction. Statistically significant decrease of endothelial dysfunction laboratory markers was revealed in patients with PMS, who underwent the course of cardiorespiratory training. In the same time, the dynamics of changes in ICAM-1 was higher in the study group than in comparative group. Further, improvement of physical and psychological components of health by SF-36 questionnaire was found. CONCLUSIONS:The program of cardiorespiratory trainings of moderate intensity in patients, who had BC treatment a year ago, decreases intercellular adhesion molecules level that may show an improvement of endothelial dysfunction.
Background: despite the great contribution of physical activity (PA) to the health of children after correction of congenital heart defects (CHD), in the literature there are only isolated data on PA and the performance of children after correction of congenital heart defects. Objective: to assess physical activity and physical performance in children after radical intervention for congenital heart disease. Material and methods. The study included 32 children after radical correction of congenital heart disease. In addition to standard research methods, all patients underwent a cardiopulmonary stress test (CPST), as well as a structured interview on physical activity. Results. According to the survey, 81 % of children did not achieve the recommended 60 minutes of daily PA. Only 44 % of children attended sports clubs or sections. The amount of sedentary time in children was 8.4 hours a day, while the duration of entertainment “screen time” was 3 hours. A separate analysis of physical performance was carried out in subgroups formed depending on physical training (PT) activities. In children who regularly engaged in PT, the threshold load power and heart rate at the height of physical activity were higher compared to children who did not engage in PT. In addition, they had higher VO2peak and lower ventilator CO2 equivalent (VE/VCO2). Conclusion. Children with corrected congenital heart disease, without contraindications to physical education and sports, mostly lead a sedentary lifestyle and have insufficient physical activity and performance. However, regular physical training after radical correction of congenital heart disease significantly increases the performance of children due to an adequate increase in cardiac output and minute ventilation during physical activity.
The COVID-19 pandemic has had an enormous impact on public health and many other social institutions. Although the disease continues evolving, new strains do not exhibit the previous lethality, and coronavirus limitations are being lifted, the problem is still relevant. An important aspect of the study of COVID-19 is the process of patient recovery, including inpatient rehabilitation programs. The aim of this pilot study was to examine the psychosocial characteristics and dynamics of the indicators of emotional state (anxiety, depression) and quality of life in patients undergoing a medical rehabilitation program after COVID-19 (N=36; mean age 63.72±12.78 years; 33.33% male, 66.67% female). Research methods included a structured interview to collect data on patients’ sociodemographic and psychosocial characteristics, the State-Trait Anxiety Inventory (STAI), the Beck’s Depression Inventory (BDI), and the 36-Item Short Health Survey (SF-36). The patients were found to have an objective perception of their physical condition, with a lack of awareness of both the disease and the rehabilitation; the illness and recovery situation was markedly stressful for the patients. During the in-patient rehabilitation period, there was a positive change in state anxiety, depressive symptoms and quality of life (p<0.001). The dynamics of the specified characteristics almost do not differ in groups of male and female patients, except for indicators of anxiety, in which differences before and after rehabilitation are more expressed among women. The findings can be used to assess the effectiveness of rehabilitation programs and to improve it, and also indicate the primary role of the clinical psychologist in managing this group of patients.
The authors have attempted to design and verify a model of comprehensive (medical, social and psychological) prognosis in cardiovascular disease, which would cover aspects of patients’ illness, treatment and life functioning. A multidisciplinary set of methods was used to realise the aim. The study included 437 patients suffering from coronary heart disease or chronic heart failure, both of ischaemic and non-ischaemic etiology, who were referred for cardiovascular surgery, and who had undergone surgical intervention.Part II of the article presents the results of the 3 final stages of the study. These are the following: 5) The studied indicators were divided into the following subgroups: “Current state factors” (reflecting the patients’ current psychological state, characterising their cognitive and emotional-affective spheres) and “Baseline factors” (reflecting relatively stable characteristics of the disease, socio-behavioural and personal features of the patients). 6) A new factor analysis was performed, resulting in 11 secondary factors: 5 in the group of “Current state factors” (“Psychological well-being”, “Quality of life in the face of cardiac disease”, “Reduced non-verbal cognitive functions due to anxiety”, “Positive mood and cognitive state”, “State of mnestic function”) and 6 in the group of “Baseline factors” (“Non-constructive behaviour in the face of disease”, “Occupational motives and severity of cardiovascular disease”, “Psychosocial risk factors for coronary heart disease”, “Patient motivation, tension and severity of chronic heart failure”, “Social support and resilience”, “Adherent behaviour and rational thinking”). 7) We used mathematical modelling and a neural network to determine the prognostic value of the above factors and to construct a systematic prediction model that will be capable of predicting the value of all “Current state factors” at any given time (days after surgery) with an accuracy of up to 80%. In the future, we plan to design a model for the “Baseline factors”.The identification of prognostically relevant patients’ characteristics at the stage of preparation for cardiac surgery can help to optimise psychological help for the patient during this time and individualise the postoperative rehabilitation programme.
Aim. To evaluate clinical and morphological data of infective endocarditis (IE) of native and prosthetic heart valves. Material and methods. This retrospective cohort study included 354 patients that had signs of IE according to pathological study of surgical material from native valves and prosthetic heart valves. The patients were divided into two groups: the first group included patients with native valve IE (n=328), while the second group — with prosthetic valve IE (n=26). Results. Among patients with native valve IE, aortic (AV) and mitral valve (MV) IE was recorded in 67,6% and 20,7%, respectively. In the group of patients with prosthetic IE, AV IE also predominated — 57,7% vs 26,9% in MV IE. In the majority of patients in the first group, secondary IE was detected (68,9%). The development of IE in the presence of bicuspid AV (BAV), degenerative AV disease, and rheumatic valve disease was revealed in 40,7%, 31,4% and 6,7%, respectively. In the group of patients with native valve IE, subactive IE was most often detected — in 38,4%, while in 7,1% — signs of process remission were detected. In the group of patients with prosthetic valve IE, IE with moderate activity was detected more often than in the group of patients with native valve IE (42,3% vs 26,8%, p=0,042). In the group of patients with prosthetic valve IE, the presence of colonies of microorganisms and neutrophilic infiltration in the histological material was somewhat more common, while in patients with native valve IE there was a tendency towards a higher percentage of necrosis in the studied material (42,4% vs 38,5%, p>0,05). Conclusion. This work confirms changes in the epidemiological characteristics of patients with IE. A high frequency of subactive forms of IE was noted according in patients with native valve IE, which requires individual approach to antibacterial therapy depending on the pathomorphological IE activity.
Aim To assess the tolerability of an individualized physical rehabilitation program (PRP) in inotrope-dependent patients with end-stage chronic heart failure (CHF). Material and methods This prospective randomized study included 120 men aged 18-65 years with left ventricular ejection fraction ≤30 % and blood pressure ≥90 / 60 mm Hg. Patients who have received dobutamine or dopamine for ≥2 weeks were randomized into two groups: group 1, 40 patients who participated in the PRP and group 2, 40 patients who did not participate in the PRP. Group 3 included 40 patients without inotropic support who participated in the PRP. Results Patients of groups 1 and 3 attended >80 % of the scheduled classes without developing life-threatening adverse events (AEs) associated with exercise (E). After 6 months of the study, the exercising patients achieved a comparable (average) E intensity: 44 [35; 50]% and 45 [40;52]% of heart rate reserve and Borg scale scores 14 [12; 14] and 13 [11; 14] in groups 1 and 3, respectively (p>0.05). Initially, after 3 and 6 months at the peak of physical activity in groups 1 and 3, there was no decrease in arterial blood oxygen saturation according to pulse oximetry (SpO 2 ) <93 %. At baseline, lactate levels in central venous blood at rest were normal in all groups. After 6 months, the lactate concentration was 1.1 mmol / l in group 1, 2.3 mmol / l in group 2, and 1.4 mmol / l in group 3 (р1-2=0.005; p2-3=0.008, respectively). At the E peak at baseline, after 3 and 6 months, comparable increases in lactate not exceeding 3 mmol / l were detected in groups 1 and 3. Conclusion The study allowed assessment of the tolerability of individualized PRP performed at the aerobic level of energy supply, in inotropic-dependent patients with CHF. Individualized 6-month PRP in inotropic-dependent patients with end-stage CHF, provided safety criteria are met, is well tolerated and does not increase the number of AEs associated with CHF and physical rehabilitation (PR). Continued inotropic support with dopamine or dobutamine should not be considered as a contraindication to PR in patients with CHF in the absence of E intolerance or life-threatening AEs.
Dyscirculatory encephalopathy is a complex of functional and structural changes in the brain that occur against the background of chronic insufficiency of cerebral blood flow. The high prevalence of this pathology, as well as a pronounced impact on the quality of life and working capacity of patients, determines the importance of optimizing rehabilitation measures and developing the most promising strategies for physical rehabilitation.OBJECTIVE:To compare the effectiveness of a special complex of therapeutic (vestibular) gymnastics and training with biofeedback (BFB) on a stabiloplatform in the rehabilitation of patients with dyscirculatory encephalopathy with vestibulo-atactic syndrome.MATERIAL AND METHODS:A cohort prospective single-center randomized comparative study of the clinical effectiveness of the author's complex of therapeutic exercises and stabilometric training with BFB in the complex treatment of patients with dyscirculatory encephalopathy with vestibulo-atactic syndrome was carried out. The study involved 40 patients aged 65-89 years who were randomized into 2 equal groups. Patients of the 1st group, against the background of drug therapy and physiotherapy, were trained on a stabiloplatform with BFB (a training game according to the manufacturer's instructions). Patients of the 2nd group performed a complex of therapeutic (vestibular) gymnastics specially designed for this study. The effectiveness of physical rehabilitation was assessed by the dynamics of (1) subjective symptoms (complaints of patients), (2) indicators of stabilometry (symmetry index, the sum of the coordination indices for the right and left legs, fluctuation) and (3) the results of functional testing using the Get up and go test, the Berg balance scale and the Tinetti mobility scale.RESULTS:In the group of patients who performed vestibular gymnastics, in contrast to patients who participated in training using a multifunctional stabiloplatform with BFB, a statistically significant improvement was revealed when assessed by the Get up and go test and the Berg balance scale. In none of the groups, a distinct dynamics of stabilometry indicators was registered. No correlation was found between the main indicators of stabilometry and the data of functional tests.CONCLUSION:Thus, vestibular gymnastics has demonstrated greater effectiveness in the rehabilitation of patients with dyscirculatory encephalopathy and vestibulo-atactic syndrome in comparison with stabilometric training with biofeedback. The discrepancy between stabilometry indicators and the results of functional testing in patients requires a targeted study.
Abstract Background In the ISCHEMIA trial, individuals randomized to the conservative strategy (CON) could undergo coronary catheterization (cath) for suspicion of an endpoint event, persistent symptoms despite optimal medical therapy, or through protocol non-adherence. Understanding the reasons for cath in CON participants can aid in ISCHEMIA results interpretation. Purpose To describe the frequency of and factors associated with early cath in ISCHEMIA CON participants. Methods A prespecified, post-hoc analysis of the 2591 CON participants was performed with multivariable analyses to identify independent factors associated with cath within 6 months of randomization (“early cath”). Results Overall 8.7% (225/2591) of CON participants underwent an early cath: with 4.6% (119/2591) for a suspected endpoint, 1.6% (41/2591) for medical treatment failure, and 2.6% (67/2591) for protocol non-adherence; 67% of all these caths (151/225) occurred within the first 3 months from randomization. Independent factors associated with cath among CON participants included daily (HR=5.84, CI: 2.73–12.47, p<0.01) and weekly (HR=2.64, CI: 1.52–4.58, p<0.01) baseline angina vs no angina, severe (HR=2.02, CI: 1.03–3.95, p=0.04) and moderate baseline quality of life impairment vs no impairment (HR=2.03, CI: 1.24–3.33, p=0.01), randomization in Europe vs Asia (HR=1.83, CI: 1.15–2.9, p=0.01), with the proviso that all these characteristics were associated with cath occurring within the first 3 months of follow-up (very early cath), but not those between 3 and 6 months (proportional hazard assumption violation). Other factors independently associated with early cath were new or increasing angina pattern over 3 months pre-randomization (HR=1.79, CI: 1.33–2.39, p<0.0001) and increases in anti-anginal medication use during follow-up (HR=1.45, CI: 1.06–1.98, p=0.02). Baseline LDL-C <70mg/dL (HR=0.65 CI: 0.46–0.91, p=0.01) and a subsiding angina pattern during follow-up (HR=0.65, CI: 0.6–0.71, p<0.01) were independently associated with a reduced hazard of early cath. Neither ischemia severity nor extent of atherosclerosis on coronary imaging showed association with cath in CON participants at 6 months. Conclusions The rate of early cath in the ISCHEMIA CON strategy was low and driven mainly by a suspected endpoint event. Severe/moderate baseline angina and quality of life impairment were independently associated with very early cath. Chances of early cath were greater with worsening pre-randomization angina and need for additional antianginal medication, and less with well controlled LDL-C and decreasing angina pattern. The baseline severity of ischemia or extent of disease on coronary imaging were not related to early cath. These results give important insight into the coronary disease treatment trajectory in the conservative strategy of the ISCHEMIA trial, further inform real-life decision making and point to the efficacy of optimal medical therapy in reducing the need for cath. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Institutes of Health, National Heart Lunch and Blood Institute
In patients with cardiovascular diseases, including CHD, the prevalence of anxiety and depression is considerable. Cognitive behavioral therapy is believed to be an effective tool for treating anxiety and depression. In the theory underlying cognitive behavioral psychotherapy, cognitive distortions play an important role. Cognitive distortions are misperception and misprocessing of information. Cognitive distortions are not a sign of mental disorders, however, their presence when assessing any situations (for example, while waiting for cardiac surgery) can lead to a range of psychological problems, in particular, to the development of anxiety and depression. Thus, the study of cognitive distortions in patients with cardiovascular diseases is of great importance in the view of the possibility of their negative impact on the mental state. Besides, according to the theoretical foundations of cognitive behavioral therapy, the presence of cognitive distortions also affects the interpersonal interaction (distorted perception of information, incorrect interpretation of behavior in the process of communication, etc.). Accordingly, the presence of cognitive distortions can also negatively affect patientdoctor interaction and adherence to treatment. The research aims to study the cognitive distortions and psychological characteristics of patients with CHD before CABG taking into consideration sex and age. The present study involved 60 patients with CHD, including 32 men (53%) and 28 women (47%). The average age of patients was 63 ± 8 years. Two groups of subjects were identified by age criterion: up to 65 years old and over 65 years old. To study cognitive distortions, the interview, and psychological testing (SCL-90-R and BIG 5 questionnaires) were carried out. All patients had different types of cognitive distortions. Men were more likely to spontaneous conclusions (37.5%), women were more likely to have overgeneralization (35%). In patients of the older age group (65<), the prevalence of dichotomous thinking was more frequent (25.92%). According to the results of the SCL-90-R questionnaire, women before CABG have higher indices of somatization, interpersonal sensitivity, and anxiety; men have higher indices of hostility. Patients over 65 years old have a higher level of somatization and depression. According to the results of the BIG 5 test, the majority of patients demonstrated a "below average" level in terms of "conscientiousness", "agreeableness", "openness to experience". For men, in terms of extraversion, the "above average" level was more common, while for women it was "level below average". When planning psychological testing and psychotherapy before CABG and during the rehabilitation, the identified psychological characteristics of patients and the specificity of cognitive distortions should be taken into account.
Coronary heart disease (CHD) is the leading cause of people's deaths in the world. Psychological intervention is a crucial factor in the treatment of CHD. One of the significant aspects of patient's forecast improvement is a compliance to treatment. Negative emotional states accompany the worsening of the course of the disease in patients with a cardiac profile. Patients with CHD are characterized by increased level of stress, depression and anxiety, non-adaptive coping strategies, defensive mechanisms and inharmonious internal picture of the disease. The psychological intervention improves compliance, the quality of life and thus speeds up physical recovery. It is crucial to determine what methods and approaches in the work of a medical psychologist are the most productive and contribute to the preservation of a long-term effect. According to several sources, the most effective and demanded approach when working with CHD patients is the cognitivebehavioral approach. It is distinguished by its shortterm impact; maintaining the duration of the effect; anxiety, stress and depression reduction; change of the internal picture of the disease, harmonizing the doctor-patient relationship, treatment adherence, compliance and improving cognitive functioning. In particular, researchers note the feasibility of methods of breathing and muscle relaxation, meditation, cognitive restructuring and diary method.
AIMS The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial prespecified an analysis to determine whether accounting for recurrent cardiovascular events in addition to first events modified understanding of the treatment effects. METHODS AND RESULTS Patients with stable coronary artery disease (CAD) and moderate or severe ischaemia on stress testing were randomized to either initial invasive (INV) or initial conservative (CON) management. The primary outcome was a composite of cardiovascular death, myocardial infarction (MI), and hospitalization for unstable angina, heart failure, or cardiac arrest. The Ghosh-Lin method was used to estimate mean cumulative incidence of total events with death as a competing risk. The 5179 ISCHEMIA patients experienced 670 index events (318 INV, 352 CON) and 203 recurrent events (102 INV, 101 CON). A single primary event was observed in 9.8% of INV and 10.8% of CON patients while ≥2 primary events were observed in 2.5% and 2.8%, respectively. Patients with recurrent events were older; had more frequent hypertension, diabetes, prior MI, or cerebrovascular disease; and had more multivessel CAD. The average number of primary endpoint events per 100 patients over 4 years was 18.2 in INV [95% confidence interval (CI) 15.8-20.9] and 19.7 in CON (95% CI 17.5-22.2), difference -1.5 (95% CI -5.0 to 2.0, P = 0.398). Comparable results were obtained when all-cause death was substituted for cardiovascular death and when stroke was added as an event. CONCLUSIONS In stable CAD patients with moderate or severe myocardial ischaemia enrolled in ISCHEMIA, an initial INV treatment strategy did not prevent either net recurrent events or net total events more effectively than an initial CON strategy. CLINICAL TRIAL REGISTRATION ISCHEMIA ClinicalTrials.gov number, NCT01471522, https://clinicaltrials.gov/ct2/show/NCT01471522.
Aim. To assess the effect of physical rehabilitation on dynamics of oxygen and lactate status indicators in inotrope-dependent patients with stable chronic heart failure (CHF) of IIIIV functional class (FC). Material and methods. A randomized prospective study included 120 men, aged 1865, hospitalized at Almazov National Medical Research Centre due to CHF IIIIV FC, left ventricular ejection fraction (LVEF) 30%; with blood pressure (BP)90/60 mm Hg. Patients who received dobutamine or dopamine for 2 weeks were randomized into 3 groups: 1st participating in the program of physical training (PPT), 2nd not participating; 3rd group patients without inotropic support participating in PPT. Results. Oxygen extraction ratio (O2ER) at rest was increased, while central venous oxygen saturation (ScvO2) was decreased in all groups at baseline, after 3 and 6 months. Initially, at rest, central venous blood lactate (lactate) was normal in all groups. By the 6th month, lactate in group 2 became higher than in group 1 (p=0.005) and group 3 (p=0.008). Initially, after 3 and 6 months, at peak of exercise in groups 1 and 3, lactate and O2ER increased, and ScvO2 decreased without development of life-threatening adverse events. By the 6th month, in groups 1 and 3, the distance of 6-minute walk test increased: p=0.004 and p0.00001 and the strength of hand muscles increased: p=0.01 and p=0.005. Conclusion. In patients with CHF IIIIV FC at rest, regardless of participation in PPT and inotropic therapy, there were comparable disturbances of oxygen status, characterized by decreased level of ScvO2 and increased level of O2ER, in the absence of decrease in arterial blood saturation. At peak of aerobic exercise of mild and moderate intensity in patients with advanced CHF, regardless of inotropic support, there was a comparable increase in the level of lactate and O2ER, as well as a decrease in ScvO2, which was not accompanied by life-threatening adverse events. The participation of inotrope-dependent patients in PPT is associated with decrease in blood lactate at rest, which, along with increase in hand muscle strength and exercise tolerance, may indicate an improvement in condition of muscle tissue.
Data on the performance of individuals with the early repolarization phenomenon (ERP) are contradictory. Aim of the study was to investigate the aerobic physical performance of individuals with ERP. Material and methods. 536 healthy men aged 18–45 years, who do not have contraindications to perform a load test according to physical, laboratory and instrumental examination (ECG, spirometry, echocardiography, clinical blood analysis), and who reached the VO2max during cardiopulmonary exercise testing were included in the study. We compared physical performance of groups formed on the basis of ECG data: the main group - persons with ERP (113 people) and the control group-persons without ERP (423 people). Results. In the group with ERP, the VO2max, cardiac output, oxygen pulse and stroke volume at peak load were lower than in the group without ERP, by 5.8 % (p=0.03), 9.2 % (p=0.05), 7.2 % (p=0.01) and 8.9 % (p=0.04). When compared to echocardiography data, the final systolic size of the left ventricle in the group with ERP was 12.6 % larger than in the group without ERP (p=0.03). Conclusion. In individuals with ERP, a decrease in cardiac output was detected, which may be associated with a relative deterioration in left ventricle systolic function and may affect the aerobic physical performance. The described differences were revealed only after removing the influence of anthropometric, spirometric and laboratory indicators.
Aim. The article presents the results of psychological investigations of patients in the terminal stage of chronic heart failure (n = 105, average age 51.9 ± 0.9 years, males – 86.7 %) undergoing medical treatment at the Almazov National Medical Research Centre (St. Petersburg). The investigations were carried out before the medical commission for inclusion of patients into the waiting list for heart transplantation (HTWL). Materials and methods. After 6 months of treatment in a cardiology hospital, the patients were divided into 2 groups – the patients included in and retained their positions in the HTWL (n = 55) and the patients not included in or excluded from the HTWL (n = 55). That was done in order to identify the prognostically significant psychosocial characteristics of patients. Clinical, psychological and psychometric methods were used such as a structured interview, expert questionnaire for doctors, the Alcohol Use Disorders Identification Test (AUDIT), the Short Form-36 (SF-36). Results. Comparative analysis reveals a wide range of psychological characteristics, among which the indicators of adherence for treatment and willingness to change lifestyle have the greatest importance. Emotional support and relationships outside the family, an adequate understanding of the disease, an optimistic assessment of the outcome of surgery treatment, etc., as well as the presence of one's own family and minor children are essential in the structure of the psychosocial potential of patients during preparation for HT. Conclusion. Using the obtained results will improve the methodology and procedure for a comprehensive clinical assessment of patients with chronic heart failure before inclusion into the waiting list for heart transplantation, which is extremely important for advanced surgical technologies.