Association of Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors with Cardiovascular Events and Death in Dialysis Patients: A Systematic Review and Meta-Analysis.

BACKGROUND: Anemia is a common finding among patients with advanced chronic kidney disease, especially those on dialysis. The recent introduction of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) has raised some concerns about the cardiovascular and thrombotic complications of this class of drugs. OBJECTIVES: This meta-analysis aimed to assess the safety of HIF-PHIs in patients with end-stage kidney disease (ESKD) versus standard therapy with erythropoiesis-stimulating agents (ESAs). METHODS: Databases were searched on April 2022. Studies that reported incidence of all-cause mortality; major cardiovascular adverse events (MACEs); myocardial infarction (MI); stroke and thrombotic events in the use of HIF-PHIs or ESA on ESKD patients in hemodialysis or peritoneal dialysis were evaluated. Data were extracted from published reports, and quality assessment was performed per Cochrane recommendations. RESULTS: 12,821 patients from ten randomized controlled trials were included in this study. Most patients (83%) were on hemodialysis. 6,461 (50.3%) were using HIF-PHIs, and 6,360 (49.6%) were in the ESA group. The pooled estimated incidence of all-cause mortality was 769 in the HIF-PHIs group (relative-risk ratios (RR): 1.04; confidence interval (CI): 0.95-1.14; p = 0.52; I2 = 0%). There was no difference in the groups regarding the outcomes of MACE in the analysis of the three studies that reported this outcome (RR: 0.95; CI: 0.87-1.04; p = 0.69; I2 = 0%). In addition, there was no statistical difference among the outcomes of MI, stroke, or thrombotic events. CONCLUSIONS: Among patients with ESKD on dialysis, the use of HIF-PHIs was non-inferior regarding the safety outcomes when compared to standard of care therapy.

Pleuroperitoneal communication in a patient on automated peritoneal dialysis: A rare but important complication.

Despite its rare frequency, a pleuroperitoneal communication is a well-documented complication for patients on peritoneal dialysis. It occurs in ~2% of continuous ambulatory peritoneal dialysis, with uncertain incidence for those on automated peritoneal dialysis. We report a case of a 30-year-old female patient with end-stage kidney disease with sudden dyspnea 2 days after starting automated peritoneal dialysis. Her chest x-ray revealed a significant pleural effusion on the right side. A thoracocentesis was performed, with a pleural glucose/plasma glucose of 1.08. Additionally, a computed tomography scan revealed a pleuroperitoneal communication upon dialysate infusion added with media contrast. A pleural-to-serum glucose gradient of greater than 50 mg/dL may indicate the diagnosis of a pleuroperitoneal communication in patients on peritoneal dialysis. Current literature also indicates that a pleural-to-serum glucose ratio above 1.0 may provide a more sensitive analysis. This case highlights the diagnosis process for this complication, with both laboratory and image findings corroborating the clinical hypotheses of a pleuroperitoneal communication in a patient on automated peritoneal dialysis.

Clinical and echocardiographic characteristics after six months of sacubitril/valsartan in Chagas heart disease - A case series.

Chagas cardiomyopathy is the most prevalent non-ischaemic cardiomyopathy in Latin America, with high morbidity and mortality even today. Treatment of these patients is based on the use of medications for heart failure. This study evaluated a case series of patients with Chagas heart disease who used sacubitril/valsartan at a referral hospital for this disease in Brazil. After 6 months, there was a symptomatic improvement in these individuals assessed by the New York Heart Association (NYHA) functional class, with a 44.3% reduction in the absolute number of patients classified as III-IV in the period (P = 0.035), but without changes in the parameters on the echocardiogram for reverse ventricular remodelling. There was a high mortality rate and number of hospitalizations. These results emphasize the importance of studying the use of sacubitril/valsartan in Chagas heart disease to better describe its effectiveness considering the particularities of these individuals.

Physician-modified Stent Graft for Total Endovascular Aortic Arch Repair.

Endovascular techniques have proven useful in aortic arch management because they allow less invasive treatment and potentially faster recovery. We present the case of a 66-year-old woman with a 2-month history of precordial pain. Imaging studies revealed a saccular aortic arch aneurysm in the anterior portion of the arch. A Valiant Navion CoveredSeal (Medtronic, Santa Rosa, CA) device was modified with a double fenestration and used to treat it. The symptoms resolved and follow-up imaging showed aneurysm exclusion and patency of the supra-aortic branches. To our knowledge, this the first total endovascular arch repair to have been performed with this device.

Association between increased mortality rate and antibiotic dose adjustment in intensive care unit patients with renal impairment.

PURPOSE: Adjusting the antibiotic dose based on an estimation of the glomerular filtration rate (eGFR) may result in subdosing, which may actually be significantly more problematic for intensive care unit (ICU) patients than not adjusting the dose. The aim of this study was to assess the outcomes of antibiotic dose adjustment in ICU patients with renal impairment. METHODS: A retrospective cohort study was conducted in adult patients admitted to an ICU of a Brazilian hospital from January 2014 to December 2015. The eGFR was determined using Cockcroft-Gault and Modified Diet in Renal Disease equations for each day of hospitalization. Treatment failure was defined based on the clinical, laboratory, and radiological criteria. RESULTS: A total of 126 patients were assessed to meet the inclusion criteria and subsequently enrolled in the study (19.9% of patients admitted to the ICU during the study period). Of the 168 opportunities for dose adjustment, 99 (58.9%) adjustments were made. The mean eGFR in the group with dose adjustment was lower than that in the group without dose adjustment (38.5 vs. 40.7 mL/min/1.73 m2, respectively). The treatment failure rate among patients with dose adjustment and those treated with the usual dose was 59.3 and 38.9%, respectively (p = 0.023), and the mortality rates in the respective groups were 74.1 and 55.5% (p = 0.033). An association between dose adjustment and treatment failure/mortality rates was also observed in the multivariate analysis including the prognostic score. CONCLUSIONS: In ICU patients with renal impairment, adjustments in antibiotic dose based on eGFR, significantly increased the risk of treatment failure and death.

In-Hospital influenza vaccination to prevent cardiorespiratory events in the first 45 days after acute coronary syndrome: A prespecified analysis of the VIP-ACS trial.

BACKGROUND: Influenza vaccination prevents major cardiovascular events in individuals presenting a recent acute coronary syndrome (ACS), however the early effect of an in-hospital double-dose vaccination strategy remains uncertain. METHODS: The VIP-ACS was a randomized, pragmatic, multicenter, open-label trial with a blinded-adjudication endpoint. Patients with ACS ≤ 7 days of hospitalization were randomized to an in-hospital double-dose quadrivalent inactivated influenza vaccine (double-dose) or a standard-dose influenza vaccine at 30 days post-randomization. The primary endpoint was a hierarchical composite of death, myocardial infarction, stroke, hospitalization for unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory infections, analyzed with the win ratio (WR) method in short-term follow-up (45-days after randomization). RESULTS: The trial enrolled 1,801 patients (≥18 years old). Median participant age was 57 years, 70 % were male. There were no significant differences between groups on the primary hierarchical endpoint: there were 5.7 % wins in the double-dose in-hospital group and 5.5 % wins in the standard-dose delayed vaccination group (WR: 1.03; 95 % CI: 0.70---1.53; P = 0.85). In a sensitivity analysis including COVID-19 infection in the hospitalizations for respiratory infections endpoint, overall results were maintained (WR: 1.03; 95 % CI 0.71---1.51; P = 0.87). Results were consistent for major cardiovascular events only (WR: 0.82; 95 % CI: 0.48---1.39; P = 0.46). No serious adverse events were observed. CONCLUSION: In patients with recent ACS, in-hospital double-dose influenza vaccination did not significantly reduce cardiorespiratory events at 45 days compared with standard-dose vaccination at 30 days post-randomization.

Safety, Effectiveness, and Hemodynamic Performance of the Bovine Pericardium Organic Valvular Bioprosthesis.

OBJECTIVE: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). METHODS: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. RESULTS: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. CONCLUSION: According to this analysis, BVP meets world standards for safety and clinical efficacy.

Inflammation in Coronary Atherosclerosis: Insights into Pathogenesis and Therapeutic Potential of Anti-Inflammatory Drugs.

Atherosclerosis is a lipid-driven immune-inflammatory disease that affects the arteries, leading to multifocal plaque development. The inflammatory process involves the activation of immune cells and various inflammatory pathways. Anti-inflammatory drugs have been shown to be effective in reducing cardiovascular events in individuals with coronary disease. However, their use is still limited due to concerns about long-term follow-up, cost-effectiveness, adverse effects, and the identification of the ideal patient profile to obtain maximum benefits. This review aims to improve the understanding of inflammation in coronary atherosclerosis and explore potential therapeutic interventions, encompassing both traditional and non-traditional anti-inflammatory approaches. By addressing these concepts, we seek to contribute to the advancement of knowledge about this type of treatment for coronary artery disease.

Quality of life analysis of patients in chronic use of oral anticoagulant: an observational study.

BACKGROUND: Treatment with oral anticoagulant may influence the quality of life perception as it promotes changes in the patient's life, not offering an evident symptomatic relief and presenting well defined risks, such as bleeding. In this trial, the influence of chronic use of anticoagulants on the quality of life perception has been analyzed in patients assisted at the anticoagulation outpatient unit. METHODS: The health related quality of life was evaluated through a cross-section study with a sample composed of 72 patients seen from July 23, 2009 to September 2, 2010 at the Anticoagulation Outpatient Unit of the Federal University of Bahia's University Hospital. The study's population was composed by patients with atrial fibrillation and mechanical heart valve. The patients were submitted to two quality of life evaluation questionnaires: a generic questionnaire - the Medical Outcomes Study SF-36 Health Survey (SF36) - and a specific questionnaire - the Duke Anticoagulation Satisfaction Scale (DASS). RESULTS: The quality of life perception of the patients studied, based on both the DASS and the SF36, was positive regarding the treatment with oral anticoagulant. The SF36 presented an average score of 62.2 (± 20.0). Among the SF36 evaluated domains, the physical-emotional aspect was the most compromised one regarding life quality perception. The DASS presented an average score of 67.1 (± 18.2) and the domain presenting a greater compromise was the one related to the treatment inconveniences (annoyances, burdens and obligations). Previous hemorrhagic event, comorbidities, drug interactions with medicines that increase the anticoagulant effect, lower education level in the SF36 and younger age group influence a more negative perception of the quality of life, whereas lower education level in the DASS and the duration of treatment for more than 1 year offer a more positive perception. CONCLUSION: Patients seen at the anticoagulation outpatient unit of the University Hospital of Federal University of Bahia/Brazil had a positive perception of the treatment. Factors such as hemorrhagic event, comorbidities, drug interactions, education level, age group and duration of treatment have an influence on the quality of life perception.

Judgement of the multidisciplinary team is an important predictor of mortality after cardiac resynchronization therapy.

AIMS: Cardiac resynchronization therapy (CRT) in appropriately selected patients with heart failure improves symptoms and survival. It is necessary to correctly identify patients who will benefit most from this therapy. We aimed to assess the predictive power of the multidisciplinary team's clinical judgement in the short-term death after CRT implantation. METHODS AND RESULTS: Patients with heart failure and referred for the first CRT implant were prospectively included. Prior to implantation, all patients underwent a systematic assessment with a team composed of social work, nurse, psychologist, nutritionist, and clinical cardiologist. Based on this assessment, patients could be contraindicated to CRT or referred to the procedure as favourable or unfavourable. All patients should complete 12 months of follow-up; 172 patients were referred for CRT, 21 (12.2%) were contraindicated after the multidisciplinary team evaluation, 71 (47%) referred to CRT as non-favourable implants, and 80 (53%) as favourable implants. All-cause mortality occurred in only 2 (2.5%) patients in the favourable group and in 30 (42.3%) in the non-favourable group, P < 0.001 (log rank). Among the 20 variables used as possible predictors of worse prognosis by the multidisciplinary team, four were independently associated with mortality in the follow-up after the multivariate analysis: 1 year MAGGIC score between 40% and 49%, relative risk (RR) 5.0, 95% confidence interval (CI) 1.3-18.6, P = 0.016; poor pharmacological adherence, RR 4.9, 95% CI 1.6-15.6, P = 0.007; glomerular filtration rate <35 mL/min/1.73 m2 , RR 3.0, 95% CI 1.1-8.5, P = 0.041; and right ventricular dysfunction, RR 2.6, 95% CI 1.2-5.7, P = 0.018. CONCLUSIONS: The clinical judgement before the CRT implantation performed by a multidisciplinary team through the analysis of clinical and psychosocial variables is a strong predictor of short-term mortality.

Older people's knowledge of the purpose of drugs prescribed at primary care appointments.

OBJECTIVE: This study aimed to assess older people's knowledge of the purpose of drugs prescribed at medical appointments in primary care units and the possible factors related to their level of knowledge about their medications. METHODS: This was a cross-sectional study conducted in 22 basic health units in Brazil. Patients aged ≥60 years were included in this study (n=674). Knowledge of prescribed medications was assessed by comparing the responses to the questionnaire and the medication and prescription information. Multivariate analyses were conducted using the Poisson regression with robust variance. RESULTS: The mean age of the sample was 70.1 (standard deviation: ±7.1) years. Among 674 patients, 272 (40.4%) did not know the indication of at least 1 of their prescribed drugs; among them, 78 (11.6%) did not know the indication of any of their prescribed drugs. In the final multivariate analysis, polypharmacy, illiteracy, and cognitive impairment were found to be associated with misunderstanding the purpose of at least one prescribed drug. Moreover, illiteracy and cognitive impairment were associated with a greater misunderstanding of the purpose of all prescribed drugs. CONCLUSIONS: In the studied sample, patients demonstrated a high rate of misunderstanding of the purpose of prescribed drugs. Therefore, it is necessary for health services and professionals to implement strategies that increase the quality of the guidance and instructions given to older people in order to promote adherence to treatment.

Cost-Effectiveness Analysis of Evolocumab Therapy in Patients at High Risk of Cardiovascular Events in the Context of the Brazilian Unified Health System. / Análise de Custo-Efetividade da Terapia com Evolocumabe em Pacientes com Alto Risco de Eventos Cardiovasculares no Contexto do SUS ­ Brasil.

BACKGROUND: Hypertrophic cardiomyopathy (HCM) and left ventricular hypertrophy (LVH) secondary to systemic hypertension (HTN) may be associated with left atrial (LA) functional abnormalities. OBJECTIVES: We aimed to characterize LA mechanics in HCM and HTN and determine any correlation with the extent of left ventricular (LV) fibrosis measured by cardiac magnetic resonance (CMR) in HCM patients. METHODS: Two-dimensional speckle tracking-derived longitudinal LA function was acquired from apical views in 60 HCM patients, 60 HTN patients, and 34 age-matched controls. HCM patients also underwent CMR, with measurement of late gadolinium enhancement (LGE) extension. Association with LA strain parameters was analyzed. Statistical significance was set at p<0.05. RESULTS: Mean LV ejection fraction was not different between the groups. The E/e' ratio was impaired in the HCM group and preserved in the control group. LA mechanics was significantly reduced in HCM, compared to the HTN group. LA strain rate in reservoir (LASRr) and in contractile (LASRct) phases were the best discriminators of HCM, with an area under the curve (AUC) of 0.8, followed by LA strain in reservoir phase (LASr) (AUC 0.76). LASRr and LASR-ct had high specificity (89% and 91%, respectively) and LASr had sensitivity of 80%. A decrease in 2.79% of LA strain rate in conduit phase (LASRcd) predicted an increase of 1cm in LGE extension (r2=0.42, ß 2.79, p=0.027). CONCLUSIONS: LASRr and LASRct were the best discriminators for LVH secondary to HCM. LASRcd predicted the degree of LV fibrosis assessed by CMR. These findings suggest that LA mechanics is a potential predictor of disease severity in HCM.

FUNDAMENTO: Em associação às estatinas, os inibidores da pró-proteína convertase subtilisina/kexina tipo 9 (PCSK9) demonstraram ser eficazes na redução de eventos cardiovasculares em pacientes de alto risco. OBJETIVO: Analisar a custo-efetividade da implementação de evolocumabe para pacientes com alto risco de eventos cardiovasculares no contexto do Sistema Único de Saúde (SUS) no Brasil. MÉTODOS: Um modelo de Markov foi utilizado, baseando-se em uma amostra ambulatorial de pacientes com doença arterial coronariana. Os desfechos primários analisados foram infarto agudo do miocárdio, acidente vascular cerebral isquêmico (AVCi), revascularização do miocárdio e morte cardiovascular. O resultado foi expresso por meio da razão de custo-efetividade incremental (RCEI), considerando-se uma taxa de desconto de 5% ao ano, e uma análise de sensibilidade foi realizada, tendo em vista a imprecisão de valores. RESULTADOS: Selecionaram-se 61 pacientes com risco cardiovascular estimado em 35% em 10 anos, se em uso de atorvastatina 80mg/dia, e em 22,75%, se adicionado o evolocumabe. O custo global por paciente no período de 10 anos foi de R$ 46.522,44 no grupo em monoterapia com atorvastatina versus R$ 236.141,85 na terapia combinada, com uma efetividade global de 0,54 e 0,73, respectivamente. Isso resultou em uma RCEI R$ 1.011.188,07 (R$ 864.498,95 a R$ 1.296.748,43) por desfecho cardiovascular evitado. CONCLUSÕES: Apesar de não existirem padrões nacionais para custo-efetividade, os dados encontrados sugerem que a estratégia de associação do evolocumabe à terapia com estatina não é, no momento, custo-efetiva.

Improving Access to the Glycated Hemoglobin Test in Rural Communities With Point-of-Care Devices: An Application Study.

Background: Living in a rural or remote area is frequently associated with impaired access to health services, which directly affects the possibility of early diagnosis and appropriate monitoring of diseases, mainly non-communicable ones, because of their asymptomatic onset and evolution. Point-of-care devices have emerged as useful technologies for improving access to several laboratory tests closely patients' beds or homes, which makes it possible to eliminate the distance barrier. Objective: To evaluate the application of point-of-care technology for glycated hemoglobin (HbA1c) estimation in the assessment of glycemic control and identification of new diagnoses of diabetes in primary care among rural communities in a Brazilian municipality. Materials and Methods: We included individuals aged 18 years or older among rural communities in a Brazilian municipality. From September 2019 to February 2020, participants were assessed for anthropometrics, blood pressure, and capillary glycemia during routine primary care team activities at health fairs and in patient groups. Participants previously diagnosed with diabetes but without recent HbA1c test results or those without a previous diagnosis but with random capillary glycemia higher than 140 mg/dL were considered positive and were tested for HbA1c by using a point-of-care device. Results: At the end of the study, 913 individuals were accessed. Of these, 600 (65.7%) had no previous diagnosis of diabetes, 58/600 (9.7%) refused capillary glycemia screening and 542/600 (90.7%) were tested. Among tested individuals, 73/542 (13.5%) cases without a previous diagnosis of diabetes, were positive for capillary glycemia. Among positives, 31/73 (42.5%) had HbA1c levels that were considered indicative of prediabetes and 16/73 (21.9%) were newly diagnosed with diabetes. Among the participants, 313/913 (34.3%) were previously diagnosed with diabetes. Recent HbA1c results were unavailable for 210/313 (67.1%). These individuals were tested using point-of-care devices. Among them, 143/210 (68.1%) had HbA1c levels higher than target levels (>7% and >8% for adults and elderly individuals, respectively. Conclusion: The application of point-of-care devices for HbA1c level measurement improved the access to this test for people living in rural or remote areas. Thus, it was possible to include this technology in the routine activities of primary health care teams, which increased the rates of new diagnoses and identification of patients with uncontrolled glycemia.

[Does any evidence exist to treat heart failure based on race or ethnicity?]. / Existe evidência para tratar insuficiência cardíaca baseada na raça ou etnia?

OBJECTIVE: To assess if there is evidence to support different interventions for treatment of heart failure based upon race/ethnicity. METHODS: Systematic review of randomized clinical trials permitted comparisons between blacks and whites with systolic heart failure concerning the efficacy of angiotensin converting enzyme (ACE) inhibitors, beta blockers and a combination of hydralazine/ nitrate to reduce the risks of death and hospitalization. The literature search was based on articles published between 1980 and December 2006 cited in MEDLINE or LILACS. RESULTS: Three studies fulfilled the criteria of the reiew. In SOLVD, enalapril was efficient in reducing the risks of death or hospitalization similarly in whites (relative risk reduction (RRR) =18%) and blacks (RRR=17%). In US Carvedilol, carvediol was also associated with significant reduction in the risk of death or hospitalization both in whites (RRR=49%) and blacks (RRR=43%). In V-HeFT II, enalapril was superior to the combination hydralazine with nitrate in reducing the death risk only in whites. CONCLUSION: According to the data ACE inhibitors and beta blockers should be considered as the essential drugs to improve the prognosis of heart failure both in blacks and whites. The A-HeFT study was not included in the review because it was restricted to blacks; however, it should be viewed as evidence that the combination hydralazine/nitrate is beneficial to improve survival in patients with advanced heart failure. Data support development of a clinical trial especially designed to assess if the combination hydralazine/nitrate is also efficient in patients not classified as blacks, with advanced heart failure.

Chagas disease is associated with a poor outcome at 1-year follow-up after cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) is a therapeutic modality for patients with heart failure (HF). The effectiveness of this treatment for event reduction is based on clinical trials where the population of patients with Chagas' disease (DC) is underrepresented. OBJECTIVE: To evaluate the prognosis after CRT of a population in which CD is an endemic cause of HF. METHODS: A retrospective cohort conducted between January 2015 and December 2016 that included patients with HF and left ventricular ejection fraction (LVEF) of less than 35% and undergoing CRT. Clinical and demographic data were collected to search for predictors for the combined outcome of death or hospitalization for HF at one year after CRT implantation. RESULTS: Fifty-four patients were evaluated, and 13 (24.1%) presented CD as the etiology of HF. The mean LVEF was 26.2± 6.1%, and 36 (66.7%) patients presented functional class III or IV HF. After the mean follow-up of 15 (±6,9) months, 17 (32.1%) patients presented the combined outcome. In the univariate analysis, CD was associated with the combined event when compared to other etiologies of HF, 8 (47%) vs. 9 (13,5%), RR: 3,91 CI: 1,46-10,45, p=0,007, as well as lower values of LVEF. In the multivariate analysis, CD and LVEF remained independent risk factors for the combined outcome. CONCLUSION: In a population of HF patients undergoing CRT, CD was independently associated with mortality and hospitalization for HF.

Safety, Effectiveness, and Hemodynamic Performance of the Bovine Pericardium Organic Valvular Bioprosthesis

ABSTRACT Objective: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). Methods: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. Results: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. Conclusion: According to this analysis, BVP meets world standards for safety and clinical efficacy.

Acute pulmonary embolism is an independent predictor of adverse events in severe decompensated heart failure patients.

BACKGROUND: Congestive heart failure (CHF) is a well-recognized risk factor for venous thromboembolism (VTE) and is associated with higher mortality in patients with an acute pulmonary embolism (PE). There are very few data on how acute PE affects the clinical course of patients with heart failure. The purpose of this study was to determine the impact of an acute PE on the short-term prognosis of patients hospitalized for decompensated CHF. METHODS: This was a prospective cohort study of 198 patients admitted to a coronary care unit between July 2001 and March 2003 with severe decompensated CHF. The primary outcome measure was death or rehospitalization at 3 months. RESULTS: PE was confirmed in 18 of 198 patients enrolled (9.1%). The groups with and without PE were comparable with regards to demographics, the prevalence of comorbid conditions, and severity of CHF (p > 0.05). The prevalence of cancer (p = 0.0001), previous VTE (p = 0.003), and right ventricular overload (p = 0.006) was higher in the PE group. The presence of PE was also associated with a longer hospital stay (37.5 +/- 71.6 days vs 15.4 +/- 15.0 days, p = 0.001) [mean +/- SD] and a higher incidence of death or rehospitalization at 3 months (72.2% vs 43.9%, p = 0.02). In a multiple logistic regression analysis, PE remained an independent predictor of death or rehospitalization at 3 months (odds ratio, 4.0; 95% confidence interval, 1.1 to 15.1; p = 0.038). CONCLUSIONS: Acute PE commonly complicates the hospital course of patients with severe CHF, increasing the length of hospital stay and the chance of death or rehospitalization at 3 months.

[Impediments in access to medical care: experiences of people with acute myocardial infarction]. / Entraves no acesso à atenção médica: vivências de pessoas com infarto agudo do miocárdio.

OBJECTIVE: To analyze the course followed by men and women who suffered an acute myocardial infarction until they received medical care. Knowledge of this course may be useful for making decisions that will lead to early and efficient care in the first minutes following the onset of symptoms, thereby reducing morbidity and mortality. METHODS: Forty-three women and 54 men who suffered a painful infarction were interviewed. Data were submitted to content analysis and statistical inference. RESULTS: The median age of men was 55.3 years and, for women of 61.5. Low education, professional inactivity and infarction taking place at home prevailed for both genders. Men had a higher family income (p=0.005) and were less likely to be living alone (p=0.001). Only 7.0% of the women made use of an ambulance. Two-thirds of the sample went directly to a hospital, but only 33% were admitted. Thus, 67.0% of the subjects wandered from place to place for up to 5 different locations before they were hospitalized. Lack of resources, denied care and being sent home by a physician were the main reasons for not being hospitalized. The place chosen for care, number of visits before hospitalization and medical attention were not gender-associated (p=NS). CONCLUSION: Men and women requiring immediate care were faced with inadequate transportation and health care establishments. The health system does not appear to be equipped to provide proper care. These findings focus on the importance and the targets of health education programs and the quality of care given to infarction patients.

IMPACTO-MR: um estudo brasileiro de plataforma nacional para avaliar infecções e multirresistência em unidades de terapia intensiva / IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units

RESUMO Objetivo: Descrever o IMPACTO-MR, um estudo brasileiro de plataforma nacional em unidades de terapia intensiva focado no impacto das infecções por bactérias multirresistentes relacionadas à assistência à saúde. Métodos: Descrevemos a plataforma IMPACTO-MR, seu desenvolvimento, critérios para seleção das unidades de terapia intensiva, caracterização da coleta de dados, objetivos e projetos de pesquisa futuros a serem realizados na plataforma. Resultados: Os dados principais foram coletados por meio do Epimed Monitor System® e consistiram em dados demográficos, dados de comorbidades, estado funcional, escores clínicos, diagnóstico de internação e diagnósticos secundários, dados laboratoriais, clínicos e microbiológicos e suporte de órgãos durante a internação na unidade de terapia intensiva, entre outros. De outubro de 2019 a dezembro de 2020, 33.983 pacientes de 51 unidades de terapia intensiva foram incluídos no banco de dados principal. Conclusão: A plataforma IMPACTO-MR é um banco de dados clínico brasileiro de unidades de terapia intensiva focado na pesquisa do impacto das infecções por bactérias multirresistentes relacionadas à assistência à saúde. Essa plataforma fornece dados para o desenvolvimento e pesquisa de unidades de terapia intensiva individuais e ensaios clínicos observacionais e prospectivos multicêntricos.

ABSTRACT Objective: To describe the IMPACTO-MR, a Brazilian nationwide intensive care unit platform study focused on the impact of health care-associated infections due to multidrug-resistant bacteria. Methods: We described the IMPACTO-MR platform, its development, criteria for intensive care unit selection, characterization of core data collection, objectives, and future research projects to be held within the platform. Results: The core data were collected using the Epimed Monitor System® and consisted of demographic data, comorbidity data, functional status, clinical scores, admission diagnosis and secondary diagnoses, laboratory, clinical, and microbiological data, and organ support during intensive care unit stay, among others. From October 2019 to December 2020, 33,983 patients from 51 intensive care units were included in the core database. Conclusion: The IMPACTO-MR platform is a nationwide Brazilian intensive care unit clinical database focused on researching the impact of health care-associated infections due to multidrug-resistant bacteria. This platform provides data for individual intensive care unit development and research and multicenter observational and prospective trials.