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The 21st Century Cures Act: can the regulatory framework survive the “cures”?
(Cadernos de Saúde Pública, 2015) Osorio-de-Castro, Claudia Garcia Serpa; Caetano, Rosângela; Pepe, Vera Lúcia Edais
In 1963, Edward Lorenz proposed a theory, which has now entered into lore, that the ripples in the air produced by the fluttering of a butterfly’s wings may cause a hurricane on the other side of the planet. In July 2015, the House of Representatives of the United States Congress approved an act that considerably alters the USA’s regulatory framework. The act, known as the 21st Century Cures Act (“ an act to accelerate the discovery, development, and delivery of 21st Century cures, and for other purposes ” 1) is now to be examined by the Senate. Both the Democratic and Republican parties worked jointly to pass this legislation.
A novel risk score for predicting new-onset atrial fibrillation in subjects with chronic chagas heart disease
(Heart Rhythm, 2010) Barbosa, Paulo R.; Tura, Bernardo R.; Barbosa-Filho, José; Kantharia, Bharat K.
Introduction: Atrial fibrillation affects about 20% of subjects with chronic Chagas disease (CCD) and heralds poor prognosis. This study prospectively investigated echocardiographic and electrocardiographic parameters aiming at creating a risk score for new-onset AF (NOAF) in CCD and to compare its performance to Rassi score. Methods: Clinically stable outpatients with CCD (34 to 74 y.o, 38 males) staged according to Los Andes (Class I: N=28; II: N=48; III: N=24) were enrolled. Patients were assessed by 12-lead ECG, 24h ambulatory ECG and 1D/2D echocardiogram. NOAF lasting >24h was tracked at three to six-month intervals. Results: During a follow-up of (mean±SEM) 91.2 ± 3.2 months, 18 developed NOAF (incidence: 30.2 ± 2.6 /year), and 20 died (rate: 26.4 ± 1.4 /year). Relative risk of NOAF for cardiac death was 3.6 (p=0.001). In multivariate Cox proportional hazard model, PVC>3,000/24h (p=0.02), LAD>3.3cm (p=0.001), and PAP>30mmHg (p=0.004) were independent predictors for NOAF (Table inset). A prognostic score for NOAF was developed by calculating weighted points proportional to beta coefficient in Cox model (table inset). ROC analysis of novel score showed optimal cut-off value at 2 (Figure A). KM curves of novel score for NOAF is presented in Figure B (proportional hazard test: rho=0.1; p=0.6). In 1,000 bootstraps, ROC c-statistic of novel score was significantly superior to Rassi score (Figure C). Conclusions: In CCD, high grade PVC, LAD>3.3cm and PAP>30mmHg are independent predictors for NOAF. Novel risk score improves NOAF predictive accuracy in this population.
A risk score based on spectral turbulence analysis of the signal averaged ECG for predicting cardiac death in subjects with chronic chagas heart disease
(Heart Rhythm, 2010) Barbosa, Paulo R.; Tura, Bernardo R.; Barbosa, Eduardo C.; Barbosa-Filho, José; Kantharia, Bharat K.
Introduction: Cardiac involvement is the main cause of death in chronic Chagas disease (CCD). This study prospectively investigated signal-averaged ECG (SAECG), 24h-ambulatory ECG and echocardiogram parameters in CCD aiming at developing a predictive score for death. Methods: Clinically stable outpatients with CCD (34 to 74 y.o, 38 males) staged according to Los Andes (Class I: N=28; II: N=48; III: N=24) were enrolled. Deaths were ascertained by review of medical records. SAECG was acquired on admission. Spectral turbulence analysis (STA) was carried out on XYZ leads after short-time Fourier transform mapping of ventricular activation, and applying intersegment spectral correlation technique. Results: During a follow-up of (mean±SEM) 95.3 ± 3.1 months, 20 patients died (rate: 26.4 ± 1.4/year). In multivariate Cox proportional hazard model, NSVT/24h (p=0.006), LVEF<50% (p<0.001), and positive STA (p=0.001) were independent predictors of death (Table inset). A prognostic score was developed by calculating weighted points proportional to beta coefficient in Cox model (Table inset). ROC analysis showed optimal cut-off value at 5 (Figure A). KM curves of novel score for deaths are presented in Figure B (proportional hazard test: rho=-0.5; p=0.06). In 1,000 bootstraps, ROC c-statistic of novel score was superior to Rassi score (Figure C). Conclusions: In CCD, NSVT, LVEF<50% and high SAECG spectral turbulence are independent predictors of death. A novel risk score improves predictive accuracy in this population.
A simple protocol for tuberculin skin test reading certification
(Cadernos de Saúde Pública, 2021) Gloria, Lara de Lima; Bastos, Mayara Lisboa; Santos Jr, Bráulio dos; Trajman, Anete
Although tuberculosis preventive therapy is one of the cornerstones for eliminating the disease, many barriers exist in the cascade of care for latent tuberculosis infection, including the need to certify healthcare professionals for reading tuberculin skin tests (TST). This paper proposes and evaluates a simple protocol for TST reading training. Primary care workers from different backgrounds received a 2-hour theoretical course, followed by a practical course on bleb reading. Blebs were obtained by injecting saline into sausages and then in volunteers. A certified trainer then evaluated the effectiveness of this protocol by analyzing the trainees' ability to read TST induration in clinical routine, blinded to each other's readings. Interobserver agreement was analyzed using the Bland-Altman test. The trainees' reading accuracy was calculated using two cut-off points - 5 and 10mm - and the effect of the number of readings was analyzed using a linear mixed model. Eleven healthcare workers read 53 saline blebs and 88 TST indurations, with high agreement for TST reading (0.07mm average bias). Sensitivity was 100% (94.6; 100.0) at 5mm cut-off and 87.3% (75.5; 94.7) at 10mm cut-off. The regression model found no effect of the number of readings [coefficient: -0.007 (-0.055; 0.040)]. A simple training protocol for reading TST with saline blebs simulations in sausages and volunteers was sufficient to achieve accurate TST induration readings, with no effect observed for the number of readings. Training with saline blebs injected into voluntary individuals is safer and easier than the traditional method.
Abdominal aortic aneurysmatic Ssc shrinking is the new paradigm after endovascular treatment
(Clinics in Surgery, 2021-07) Espinosa, Gaudencio; Saad, Pedro; di Luccio, Giovanni; Vaz, Pedro Duarte; Baptista, Luiz; Magliano, Carlos
Objectives: Aneurysmal Sac (SAC) absorption after endovascular treatment (EVAR) of Abdominal Aortic Aneurysms (AAA) is related to a better prognosis but its long-term mandatory and predictive factors remain unclear. Our study aims to assess the impact of its total resorption on patient survival, as well as the factors that favor resorption. Methods: We followed a187 patients who underwent EVAR with a fully thrombosed SAC for 22 years in the postoperative control of Angio-CT. We established the significance of the factors for SAC resorption by logistic regression models, evaluating comorbidities, diameter, sex and age of the patient. We also compared the impact of absorption sac absorption with survival. Results: Diameter and age were significant for the resorption of the SAC together or even independently (p-value <0.001), the diameter (OR-0.29) showed a greater influence than age (OR= -0.063). The comorbidities studied and the sex of the patients was not statistically significant. Patients who had significant absorption (≥ 10 mm) had a survival rate of 12.72 ± 0.96 years, those with moderate absorption (5 mm to 9 mm) had of 8.34 ± 1.62 years and those without significant resorption or growth had 3.27 ± 0.48 years (p-value <0.001). Among patients with absorption of ≥ 5 mm in the first year, we found greater chances of total absorption (OR=4.72 p-value <0.001). Conclusion: Total sac resorption proved to be an important prognostic factor for patient survival after EVAR. The age of the patient and mainly the initial diameter of the sac were the factors significantly associated with the resorption of the sac.
Ablação por radiofrequência da taquicardia por reentrada nodal: experiência com 112 pacientes no Instituto Nacional de Cardiologia (2012-2015)
(Instituto Nacional de Cardiologia, 2017) Rodrigues, Leandro Cordeiro Dias
As taquicardias paroxísticas supraventriculares são arritmias comuns na prática clínica, que apesar de geralmente evoluírem benignamente, podem incidir com sintomas desconfortáveis e trazer custos significativos em tratamentos, diagnósticos e hospitalizações. A taquicardia por reentrada nodal é a forma mais comum de taquicardia paroxística supraventricular, perfazendo 50% dos casos. O tratamento definitivo de escolha desta é a ablação por cateter, pois é um procedimento seguro com taxas de sucesso próximas a 98% e com taxas de complicações graves menores do que 1,0%, sendo a mais comum o bloqueio atrioventricular total. O presente trabalho objetivou o estudo das taxas de sucesso, insucesso e de complicações da ablação da taquicardia por reentrada nodal no Instituto Nacional de Cardiologia, sendo estas variáveis analisadas retrospectivamente em todos os pacientes submetidos a estudo eletrofisiológico e/ou ablação durante o período de janeiro de 2012 a dezembro de 2015, em que durante o procedimento foi diagnosticado taquicardia por reentrada nodal ou presença de dupla via nodal em pacientes sintomáticos com ou sem documentação eletrocardiográfica prévia de surto de taquicardia paroxística supraventricular. Estes critérios contemplaram 112 pacientes que foram submetidos a 116 ablações de taquicardia por reentrada nodal. As taxas de sucesso imediato, complicações graves e de recidivas foram 99,1%, 2,7% e 13,2% respectivamente. Em relação as complicações graves, dois (1,8%) pacientes evoluíram com bloqueio atrioventricular total durante aplicação de radiofrequência necessitando de implante de marcapasso definitivo e um paciente evolui com hematoma retroperitoneal necessitando de hemotransfusão e suporte intensivo. Finalmente, é importante ressaltar que taxa de sucesso imediato foi de 99,1 %. A ablação por radiofrequência da taquicardia por reentrada nodal mostrou-se um procedimento seguro. Complicações graves ocorreram em três (2,7%) pacientes e foram tratadas sem resultar em nenhum caso de óbito.
Accuracy of ltrassonography in the diagnosis of hepatic steatosis and abdominal fat in adolescents: a systematic rewiew
(PARIPEX - Indian Journal of Research, 2018) Takey, Márcia; d'Abreu, Henrique César Chaves; Beker, Roseanne Szumsztajn B; Santos, Bráulio; Santos, Marisa da Silva; Kuschnir, Maria Cristina Caetano
INTRODUCTION: With the growing number of overweight adolescents, there was an increase in the prevalence of non-alcoholic fatty liver disease. MATERIAL AND METHOD: We performed a systematic review of the literature to identify and synthesize the available evidence on the ultrasonography accuracy in the diagnosis of hepatic steatosis and measurement of abdominal fat compared to computed tomography or magnetic resonance imaging in obese adolescents. Seven databases (MEDLINE, Cochrane Database of Systematic Reviews, SCOPUS, WEB of SCIENCE, EMBASE, LILACS and ADOLEC) were reviewed. RESULTS: three studies were included in a qualitative synthesis. CONCLUSIONS: Ultrasonography does not have the accuracy needed to classify the degree of steatosis. Magnetic resonance imaging would be considered a more useful and objective method than ultrasonography to discriminate differences in liver fat content and for monitoring of young patients with hepatic steatosis
Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT)
(Circulation, 2011) ACT Investigators; Tura, Bernardo R; Santos Junior, Bráulio dos; Cramer, Helena
Background: It remains uncertain whether acetylcysteine prevents contrast-induced acute kidney injury. Methods and results: We randomly assigned 2308 patients undergoing an intravascular angiographic procedure with at least 1 risk factor for contrast-induced acute kidney injury (age >70 years, renal failure, diabetes mellitus, heart failure, or hypotension) to acetylcysteine 1200 mg or placebo. The study drugs were administered orally twice daily for 2 doses before and 2 doses after the procedure. The allocation was concealed (central Web-based randomization). All analysis followed the intention-to-treat principle. The incidence of contrast-induced acute kidney injury (primary end point) was 12.7% in the acetylcysteine group and 12.7% in the control group (relative risk, 1.00; 95% confidence interval, 0.81 to 1.25; P=0.97). A combined end point of mortality or need for dialysis at 30 days was also similar in both groups (2.2% and 2.3%, respectively; hazard ratio, 0.97; 95% confidence interval, 0.56 to 1.69; P=0.92). Consistent effects were observed in all subgroups analyzed, including those with renal impairment. Conclusions: In this large randomized trial, we found that acetylcysteine does not reduce the risk of contrast-induced acute kidney injury or other clinically relevant outcomes in at-risk patients undergoing coronary and peripheral vascular angiography. Clinical trial registration: http://www.clinicaltrials.gov. Unique identifier: NCT00736866.
Acurácia do relacionamento probabilístico na avaliação da alta complexidade em cardiologia
(Revista de Saúde Pública, 2011) Migowski, Arn; Chaves, Rogério Brant Martins; Coeli, Cláudia Medina; Ribeiro, Antonio Luiz Pinho; Tura, Bernardo Rangel; Kuschnir, Maria Cristina Caetano; Azevedo, Vitor Manuel Pereira; Floriano, Daniel Brasil; Magalhães, Carlos Alberto Moreira; Pinheiro, Márcia Cristina Chagas Macedo; Xavier, Regina Maria de Aquino
OBJETIVO: Avaliar a viabilidade de estratégia de relacionamento probabilístico de bases de dados na identificação de óbitos de pacientes submetidos a procedimentos de alta complexidade em cardiologia. MÉTODOS: O custo de processamento foi estimado com base em 1.672 registros de pacientes submetidos à cirurgia de revascularização do miocárdio, relacionados com todos os registros de óbito no Brasil em 2005. A acurácia do relacionamento baseou-se em linkage probabilístico entre 99 registros de autorização de internação hospitalar de pacientes submetidos a cirurgias cardíacas em instituto de referência em cardiologia, com status vital conhecido, e todos os registros de óbito do estado do Rio de Janeiro em 2005. O linkage foi realizado em quatro etapas: padronização das bases, blocagem, pareamento e classificação dos pares. Utilizou-se a blocagem em cinco passos, com chaves de blocagem com combinação de variáveis como soundex do primeiro e último nome, sexo e ano de nascimento. As variáveis utilizadas no pareamento foram "nome completo", com a utilização da distância de Levenshtein, e "data de nascimento". RESULTADOS: O segundo e o quinto passos de blocagem tiveram os maiores números de pares formados e os maiores tempos de processamento para o pareamento. O quarto passo demandou menor custo de processamento. No estudo de acurácia, após os cinco passos de blocagem, a sensibilidade do linkage foi de 90,6% e a especificidade foi de 100%. CONCLUSÕES: A estratégia de relacionamento probabilístico utilizada apresenta boa acurácia e poderá ser utilizada em estudos sobre a efetividade dos procedimentos de alta complexidade e alto custo em cardiologia.
Acute and subacute hemodynamic responses and perception of effort in subjects with chronic chagas cardiomyopathy submitted to different protocols of inspiratory muscle training: a cross-over trial
(Disability and Rehabilitation, 2020) Frota, Aline Xavier; Mendes, Fernanda de Souza Nogueira Sardinha; Vieira, Marcelo Carvalho; Saraiva, Roberto Magalhães; Veloso, Henrique Horta; Silva, Paula Simplício da; Silva, Gilberto Marcelo Sperandio da; Sousa, Andréa Silvestre de; Mazzoli-Rocha, Flavia; Costa, Henrique Silveira; Rodrigues Junior, Luiz Fernando; Mediano, Mauro Felippe Felix
Purpose: This study aimed to evaluate acute and subacute hemodynamic responses and perception of effort in individuals with CCC submitted to different IMT protocols. Materials and methods: This was a randomized cross-over trial conducted on CCC subjects with systolic left ventricular dysfunction (<45% left ventricular ejection fraction) without or with heart failure (stages B2 and C, respectively). Twenty-one participants performed two IMT protocols, one targeting 60% maximal inspiratory pressure with 3 × 10 repetitions (MIP60) and the other targeting 30% maximal inspiratory pressure (MIP30) with 3 × 20 repetitions with a 2 min recovery between sets for both. MIP60 and MIP30 were performed on the same day with a 2 h washout period. Measurements were taken at baseline, during and 60 min after IMT. Results: No differences in hemodynamic variables were observed across protocols. The perception of effort increased in both protocols, with higher scores for the MIP30 protocol (β = +1.6, p = 0.01; β = +1.1, p = 0.02; β = +0.9, p = 0.08 for the 1st, 2nd and 3rd sets, respectively). Conclusions: There were no differences in hemodynamic responses comparing MIP60 and MIP30 protocols in subjects with CCC. Despite the higher perception of effort during endurance protocol, both protocols can be considered a safe therapeutic strategy.IMPLICATIONS FOR REHABILITATIONDespite inspiratory muscle training may result in functional capacity improvements, no previous study evaluated the hemodynamic acute and subacute responses to inspiratory muscle training in chronic Chagas cardiomyopathy.The two inspiratory muscle training protocols (30% and 60% of maximal inspiratory pressure) did not cause significant hemodynamic repercussions in subjects with chronic Chagas cardiomyopathy.Inspiratory muscle training seems to be an effective strategy to improve functional capacity and can be implemented in the rehabilitation programs for patients with Chagas cardiomyopathy.Since no significant adverse responses were observed in any of the hemodynamic parameters during the inspiratory muscle training sessions, these two protocols of inspiratory muscle training (30% and 60% of maximal inspiratory pressure) seems to be safe in subjects with Chagas cardiomyopathy.
Acute cardiac injury in patients with covid-19
(American Journal of Cardiovascular Disease, 2020) Lorenzo, Andrea De; Kasal, Daniel Barata; Tura, Bernardo Rangel; Rey, Helena Cramer; Lamas, Cristiane C.
Introduction: Cardiac complications of COVID-19 are potentially life-threatening. The occurrence of myocardial injury in the context of COVID-19 is multifactorial and has generated increasing interest. Methods: A systematic review with a meta-analysis of the literature was performed. MEDLINE and EMBASE were searched. Two independent reviewers evaluated the selected manuscripts for the outcome “myocardial injury”, defined by troponin elevation above the 99th percentile. The study heterogeneity and risk of bias were evaluated. Results: Eight studies, with a total of 1,229 patients, were included. The frequency of myocardial injury was 16% (95% CI: 9%-27%). The heterogeneity among the studies was high (93%). Conclusions: Myocardial injury may occur in patients with COVID-19, with a frequency of 16% according to current studies. Continuous research is needed to update these findings as the pandemic evolves and to define the implications of myocardial injury in the context of this infection.
Acute cellular rejection and HLA mismatch in heart transplantation: insights from a developing country
(Clinical Transplantation, 2016) Schtruk, Lígia Beatriz Chaves Espinoso; Guimarães, Tereza Cristina Fellipe; Pôrto, Luis Cristóvão; Kuschnir, Maria Cristina Caetano; Colafranceschi, Alexandre Siciliano; Silva Filho, Paulo Moreira da; Lorenzo, Andrea De
The notable evolution of heart transplant (HTX) has paralleled the capacity of diagnosing rejection and, consequently, initiating timely treatment. Acute cellular rejection, diagnosed by endomyocardial biopsy, is the most frequent in the first 6 months after HTX. HLA matching is not routinely performed in HTX due to the absence of consensus regarding its usefulness. However, the use of HLA typing might be underscored if it could predict an increased risk of rejection. Therefore, the aim of this study was to evaluate, at a public cardiology center in Brazil, the association between HLA mismatches and the incidence of acute cellular rejection in the first 6 months after HTX. Data were obtained from hospital records and from the National Transplant System. Overall, there was no association between the number of HLA mismatches and the frequency of acute cellular rejection, but there was a tendency toward a higher incidence of rejection with HLA-DR incompatibility.
Acute coronary syndrome, a rare manifestation of infective endocarditis: a case report
(Heart, Vessels and Transplantation, 2020) Tagliari, Fabio; Ribeiro, Caio Leal; Carvalho, Gabriel Padua Valladao de; Tagliari, Lais Pedroso; Weksler, Clara; Lamas, Cristiane da Cruz
Systemic embolization in infective endocarditis is common, occurring in 45-65% of cases. However, the septic coronary embolization is a complication rarely described as a cause of acute myocardial infarction (AMI). The presentation of chest pain as the first manifestation of endocarditis is associated with a poor prognosis. Mitral valve endocarditis with embolization to the left anterior descending coronary is the most common situation described in the literature. We present a case of a young male patient with typical angina caused by acute myocardial infarction, who had an obstructive lesion to the marginal branch of the circumflex artery in the angiography, and was later diagnosed with aortic valve endocarditis.
Adequação da ingestão de macronutrientes e micronutrientes e sua relação com o estado nutricional em um grupo de idosos frequentadores do centro de atenção à saúde do idoso e cuidador da UFF/RJ
(Brazilian Journal of Health Review, 2020) Barroso, Taianah Almeida; Huguenin, Grazielle Vilas Boas; Lopes, Maylin da Silva; Amaral, Ludmila Ferreira Vieira do; Sá, Selma Chaves Petra; Barroso, Sérgio Girão; Rocha, Gabrielle de Souza; Medeiros, Renata Frauches
A população idosa é um dos grupos etários de maior risco à desnutrição e deficiências nutricionais devido ao declínio das funções cognitivas e fisiológicas que prejudicam a ingestão alimentar e o metabolismo dos nutrientes. Dessa forma é necessário o monitoramento e a caracterização das práticas alimentares e de seus determinantes nessa população, com vistas à prevenção dos distúrbios nutricionais e doenças a eles relacionadas. Os objetivos foram avaliar se a ingestão de macronutrientes (carboidrato, proteínas e lipídios) e micronutrientes (cálcio e vitamina D) pelos idosos estavam de acordo com as recomendações, e verificar a relação das variáveis antropométricas com os nutrientes. O estudo foi aprovado pelo Comitê de Ética. Trata-se de um estudo transversal com 34 pacientes, com idade acima de 60 anos, de ambos os sexos. Foram realizadas medidas antropométricas (peso, estatura, índice de massa corporal (IMC); circunferência abdominal, cintura, pescoço e quadril). O recordatório alimentar de 24 horas foi utilizado para calcular a ingestão dos nutrientes e a prevalências de inadequação dos micronutriente foi estimada utilizando como ponto de corte os valores da Estimated Average Requirement (EAR). Participaram do estudo 34 voluntários sendo 30 mulheres (88,2%) e 4 homens (11,7%). A média de idade foi de 72,37±13,27 anos, do IMC foi 28,47±4,45 kg/m², o que caracteriza sobrepeso na amostra. Em relação aos macronutrientes eles se encontraram adequados em relação as recomendações, sendo proteínas (20,7%), carboidratos (52,7%), e lipídios (26,6%). A ingestão de cálcio entre as mulheres apresentou um percentual de adequação de 41,66% semelhante a dos homens que foi 41,84%. Em relação a vitamina D encontramos 12,66% de adequação para ambos. A ingestão de vitamina D apresentou uma correlação inversa e significativa com o perímetro abdominal (r= -0,3718), IMC (r= -0,4919) e perímetro do pescoço (r= -0,4038), e o cálcio com o perímetro do pescoço (r=-0,4129). Verificou-se que apesar dos macronutrientes se adequados, a ingestão dos micronutrientes estudados se encontravam abaixo da recomendação, e esse valores estão relacionados com os preditores de gordura corporal da população.
Adverse events in adults with latent tuberculosis infection receiving daily rifampicin or isoniazid: post-hoc safety analysis of two randomised controlled trials
(The Lancet: Infectious Diseases, 2020) Campbell, Jonathon R; Trajman, Anete; Cook, Victoria J; Johnston, James C; Adjobimey, Menonli; Ruslami, Rovina; Eisenbeis, Lisa; Fregonese, Federica; Valiquette, Chantal; Beneditti, Andrea; Menzies, Dick
Background An important problem limiting treatment of latent tuberculosis infection is the occurrence of adverse events with isoniazid. We combined populations from phase 2 and phase 3 open-label, randomised controlled trials, to establish risk factors for adverse events during latent tuberculosis infection treatment. Methods We did a post-hoc safety analysis based on data from two open-label, randomised controlled trials done in health-care facilities in Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Saudi Arabia, and South Korea. Participants were consenting adults (aged ≥18 years) with a positive latent tuberculosis infection diagnostic test, indication for treatment, and without contraindications to rifampicin or isoniazid. Patients were centrally randomly assigned 1:1 to 4 months of daily 10 mg/kg rifampicin or 9 months of daily 5 mg/kg isoniazid. The primary outcome evaluated was adverse events (including grade 1–2 rash and all events of grade 3–5) resulting in permanent discontinuation of study medication and judged possibly or probably related to study drug by a masked, independent,three-member adjudication panel (trial registration: NCT00170209; NCT00931736). Findings Participants were recruited from April 27, 2004, up until Jan 31, 2007 (phase 2), and Oct 1, 2009, up until Dec 31, 2014 (phase 3). The safety populations for each group comprised 3205 individuals receiving isoniazid and 280 receiving rifampicin. Among those receiving isoniazid, 86 (2·7%) of 3205 had grade 1–2 rash or any grade 3–5 adverse events, more than the 50 (1·5%) of 3280 who had these events with rifampicin (risk difference –1·2%, 95% CI –1·9 to –0·5). Age was associated with adverse events in adults receiving isoniazid. Compared with individuals aged 18–34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1–3·0) for individuals aged 35–64 years and 3·0 (1·2–6·8) for individuals aged 65–90 years. With rifampicin, adverse events were associated with inconsistent medication adherence (adjusted OR 2·0, 1·1–3·6) and concomitant medication use (2·8, 1·5–5·2), but not age, with an adjusted OR of 1·1 (0·6–2·1) for individuals aged 35–64 years and 1·7 (0·5–4·7) for individuals aged 65–90 years. One treatment-related death occurred in the isoniazid group. Interpretation In patients without a contraindication, rifampicin is likely to be the safest latent tuberculosis infection treatment option. With more widespread use of rifampicin, rare, but serious adverse events might be seen. However, within these randomised trials, rifampicin was safer than isoniazid and adverse events were not associated with older age. Therefore, rifampicin should become a primary treatment option for latent tuberculosis infection based on its safety.
Adverse events related to intravenous antibiotic therapy: a prospective observational study in the treatment of infective endocarditis
(BMJ Open, 2012) Paula, Débora Holanda Gonçalves de; Tura, Bernardo Rangel; Lamas, Cristiane da Cruz
Objective: The goal of this prospective observational study was to identify adverse events (AEs) related to the use of intravenous access sites used for infective endocarditis (IE) treatment in a tertiary care hospital. Design: This is an observational, analytical and prospective study on AEs resulting from the use of intravenous access sites in patients under antimicrobial treatment for IE. Patients enrolled in the International Collaboration on Endocarditis (ICE) study had their peripheral, short-term central catheters (CVC) and peripherally inserted central catheters (PICC) monitored for AEs. Setting: Tertiary care hospital for cardiac surgery in Rio de Janeiro, Brazil. Patients: Patients over 14 years of age, hospitalised in 2009 and 2010 with possible or definite criteria for IE by the modified Duke criteria were included. Main outcome measures: AEs related to intravenous catheters: erythema and infiltration, fever, obstruction, externalisation and blood stream infection. Results: Thirty-seven episodes of IE in 35 patients were studied. Mean patient age was 44.32±15.2 years; 22 (63%) were men. The number of vascular catheters studied were 253, 148 of which were peripheral, 85 CVC (21 of which for haemodialysis) and 20 PICC. The most frequent AEs were 'erythema' and 'infiltration' for peripheral catheters, 'fever' for CVCs and 'obstruction' and 'externalisation' for PICCs. The number of catheter-days was 360 for peripheral catheters, 1.156 for CVC and 420 for PICC. Kaplan-Meier curves for CVC and PICC showed statistical difference for obstruction (p<0.001) in PICCs. More bacteraemia occurred in CVC compared with PICC. Conclusions: The choice of intravenous access sites is critical in the treatment of IE. Close observation for AEs and stricter implementation of infection control measures and better manipulation of catheters are suggested.
Age influences outcomes in 70-year or older patients undergoing isolated coronary artery bypass graft surgery
(Revista Brasileira de Cirurgia Cardiovascular, 2012) Rocha, Antônio Sergio C. da; Pittella, Felipe; De Lorenzo, Andrea; Barzan, Valmir; Colafranceschi, Alexandre Siciliano; Brito, José Oscar R.; Mattos, Marco Antonio de; Silva, Paulo Roberto Dutra da
Objetivo: Analisar os resultados da cirurgia de revascularização miocárdica (CRVM) isolada com circulação extracorpórea em pacientes com idade ³ 70 anos em comparação àqueles com < 70 anos. Métodos: Pacientes submetidos consecutivamente à CRVM isolada. Os pacientes foram agrupados em G1 (idade³ 70 anos) e G2 (idade < 70 anos). Os desfechos analisados foram letalidade hospitalar, infarto agudo miocárdio (IAM), acidente vascular encefálico (AVE), reoperação para revisão de hemostasia (RRH), necessidade de balão intra-aórtico (BIA), complicações respiratórias, insuficiência renal aguda (IRA), mediastinite, sepse, fibrilação atrial (FA) e bloqueio atrioventricular total (BAVT). Resultados: Foram estudados 1033 pacientes, 257 (24,8%) do G1 e 776 (75,2%) do G2. A letalidade hospitalar foi significantemente maior no G1 quando comparado ao G2 (8,9% vs. 3,6%, P=0,001), enquanto a incidência de IAM foi semelhante (5,8% vs. 5,5%; P=0,87). Maior número de pacientes do G1 necessitou de RRH (12,1% vs. 6,1%; P=0,003). Da mesma forma, no G1 houve maior incidência de complicações respiratórias (21,4% vs. 9,1%; P<0,001), mediastinite (5,1% vs. 1,9%; P=0,013), AVE (3,9% vs. 1,3%; P=0,016), IRA (7,8% vs. 1,3%, P<0,001), sepse (3,9% vs. 1,9%; P=0,003), fibrilação atrial (15,6% vs. 9,8%; P=0,016) e BAVT (3,5% vs. 1,2%; P=0,023) do que o G2. Não houve diferença significante na necessidade de BIA. Na análise regressão logística multivariada “forward stepwise”, a idade ³ 70 anos foi fator preditivo independente para maior.
Alectinib para Câncer de Pulmão Não Pequenas Células
(Instituto Nacional de Cardiologia, 2020) Silva, Eduardo Henrique da Silva de Lima e
Alerta de monitoramento do horizonte tecnológico: Ivacaftor (Kalydeco®) para fibrose cística
(Ministério da Saúde, 2017) Santos, Marisa da Silva; Medeiros, Bruna; Souza, Charlles Zapp de
O presente alerta destina-se a informar a sociedade (pacientes, operadores do direito, profissionais da saúde e formuladores de políticas, entre outros) quanto aos potenciais impactos de tecnologias emergentes (em estágio de desenvolvimento) e novas (em fase de aprovação ou recém-aprovadas por agências reguladoras) no cuidado aos pacientes, no sistema de saúde e na organização dos serviços. Este documento foi elaborado com base nas melhores evidências científicas disponíveis, mas não se trata de um guia de prática clínica e não representa posicionamento favorável ou desfavorável do Ministério da Saúde quanto à utilização das tecnologias em saúde analisadas.
Anais do 44º Simpósio do Instituto Nacional de Cardiologia: inovação, inclusão e sustentabilidade
(Instituto Nacional de Cardiologia, 2023) Instituto Nacional de Cardiologia
O 44º Simpósio do Instituto Nacional de Cardiologia aconteceu nos dias 12 e 13 de setembro de 2023, no Hotel Prodigy Santos Dumont, tendo por tema Inovação, inclusão e sustentabilidade e como objetivo promover a discussão sobre como permitir o acesso da população às inovações tecnológicas, a procedimentos, a processos e a medicações, na área da saúde cardiovascular. O acesso passa por dar a conhecer a prática assistencial, de ensino e de pesquisa no INC, por meio da divulgação de suas atividades, e de viabilizar a inclusão dos usuários como pacientes ou alunos na Instituição. A sustentabilidade nos remete à excelente gestão necessária para promover este acesso. As discussões abordam os desafios impostos nas várias áreas de atuação: cirurgia cardiovascular (incluindo transplante), coronariopatia, dislipidemia e outros fatores de risco cardiovascular, valvopatias, implantes percutâneos de válvula, miocardiopatias e insuficiência cardíaca, aortopatias, cardiologia da criança e do adolescente, arritmias, terapia intensiva, enfermagem, fisioterapia, assistência social, gestão, ética e qualidade. Presença de convidados nacionais e internacionais para as mesas redondas, colóquios e palestras. O evento inclui o 2º Encontro de Inovação do Instituto Nacional de Cardiologia, o 4º Simpósio Internacional de Cirurgia Cardiovascular Pediátrica e Congênita, o 4º Simpósio Internacional do Mestrado em Ciências Cardiovasculares, o 4º Fórum de Cardio-Oncologia INCA INC SBC, o 4º Fórum Nacional de Transplante Cardíaco e o 11º Workshop de Cirurgia Cardíaca com Hands On.

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