Stress Load and Ascending Aortic Aneurysms: An Observational, Longitudinal, Single-Center Study Using Computational Fluid Dynamics.

Ascending aortic aneurysm (AAoA) is a silent disease with high mortality; however, the factors associated with a worse prognosis are not completely understood. The objective of this observational, longitudinal, single-center study was to identify the hemodynamic patterns and their influence on AAoA growth using computational fluid dynamics (CFD), focusing on the effects of geometrical variations on aortic hemodynamics. Personalized anatomic models were obtained from angiotomography scans of 30 patients in two different years (with intervals of one to three years between them), of which 16 (53%) showed aneurysm growth (defined as an increase in the ascending aorta volume by 5% or more). Numerically determined velocity and pressure fields were compared with the outcome of aneurysm growth. Through a statistical analysis, hemodynamic characteristics were found to be associated with aneurysm growth: average and maximum high pressure (superior to 100 Pa); average and maximum high wall shear stress (superior to 7 Pa) combined with high pressure (>100 Pa); and stress load over time (maximum pressure multiplied by the time interval between the exams). This study provides insights into a worse prognosis of this serious disease and may collaborate for the expansion of knowledge about mechanobiology in the progression of AAoA.

Long-Term Protective Effect of Tuberculosis Preventive Therapy in a Medium/High Tuberculosis Incidence Setting.

BACKGROUND: The duration of the protective effect of tuberculosis preventive therapy (TPT) is controversial. Some studies have found that the protective effect of TPT is lost after cessation of therapy among people with human immunodeficiency virus (HIV) in settings with very high tuberculosis incidence, but others have found long-term protection in low-incidence settings. METHODS: We estimated the incidence rate (IR) of new tuberculosis disease for up to 12 years after randomization to 4 months of rifampin or 9 months of isoniazid, among 991 Brazilian participants in a TPT trial in the state of Rio de Janeiro, with an incidence of 68.6/100 000 population in 2022. The adjusted hazard ratios (aHRs) of independent variables for incident tuberculosis were calculated. RESULTS: The overall tuberculosis IR was 1.7 (95% confidence interval [CI], 1.01- 2.7) per 1000 person-years (PY). The tuberculosis IR was higher among those who did not complete TPT than in those who did (2.9 [95% CI, 1.3-5.6] vs 1.1 [.4-2.3] per 1000 PY; IR ratio, 2.7 [1.0-7.2]). The tuberculosis IR was higher within 28 months after randomization (IR, 3.5 [95% CI, 1.6-6.6] vs 1.1 [.5-2.1] per 1000 PY between 28 and 143 months; IR ratio, 3.1 [1.2-8.2]). Treatment noncompletion was the only variable associated with incident tuberculosis (aHR, 3.2 [95% CI, 1.1-9.7]). CONCLUSIONS: In a mostly HIV-noninfected population, a complete course of TPT conferred long-term protection against tuberculosis.

Inibidores BTK e BCL-2 no Tratamento de Primeira Linha da Leucemia Linfocítica Crônica em Pacientes de Alto Risco: Revisão Sistemática e Meta-Análise em Rede / BTK and BCL-2 Inhibitors in the First-Line Treatment of Chronic Lymphocytic Leukemia in High-Risk Patients: Systematic Review and Network Meta-Analysis / Inhibidores de BTK Y BCL-2 en el Tratamiento de Primera Línea de la Leucemia Linfocítica Crónica en Pacientes de Alto Riesgo: Revisión Sistemática y un Metaanálisis en Red

Introdução: Pacientes com leucemia linfocítica crônica (LLC) com alto risco têm menores taxas de resposta, curso clínico mais agressivo e resistência à quimioterapia padrão, representando um desafio para o tratamento. Os inibidores da tirosina quinase de Bruton (BTK ­ ibrutinibe e acalabrutinibe) e o inibidor BCL-2 (venetoclax) podem ser utilizados nesses casos. Objetivo: Identificar e avaliar a eficácia e a segurança do uso de ibrutinibe, acalabrutinibe e venetoclax no tratamento de primeira linha em pacientes com LLC de alto risco. Método: Revisão sistemática de ensaios clínicos randomizados que avaliaram pacientes adultos com LLC, portadores de deleção 17p ou mutação TP53 e sem tratamento prévio. Foram pesquisadas as bases PubMed, EMBASE, LILACS e Cochrane Library, e realizadas avaliação do risco de viés pela ferramenta RoB 2 da Cochrane e avaliação da qualidade da evidência pelo GRADE. Resultados: Na meta-análise em rede para sobrevida livre de progressão (SLP), venetoclax + obinutuzumabe (RR: 0,62; IC 95% 0,41-0,95; p = 0,027) e acalabrutinibe + obinutuzumabe (RR: 0,74; IC 95% 0,55-0,99; p = 0,043) apresentaram menor risco de progressão ou óbito, com significância considerada limítrofe. Ibrutinibe + obinutuzumabe (RR: 0,93; IC 95% 0,86-1,00; p = 0,054) não apresentou diferença significativa na SLP para pacientes com LLC de alto risco. Conclusão: O tratamento de primeira linha com inibidores de BTK (ibrutinibe e acalabrutinibe) e o inibidor BCL-2 (venetoclax), associados a agentes monoclonais anti-CD20 ­ especialmente o obinutuzumabe ­, tem sido proposto como padrão para a maioria dos pacientes com LLC. Entretanto, pelos resultados desta revisão com meta-análise em rede, não foi possível confirmar essa recomendação.

Introduction: Patients with high-risk chronic lymphocytic leukemia (CLL) have lower response rates, a more aggressive clinical course, and resistance to standard chemotherapy, representing a treatment challenge. Bruton's tyrosine kinase inhibitors (BTK ­ ibrutinib and acalabrutinib) and the BCL-2 inhibitor (venetoclax) can be used in these cases. Objective: To identify and evaluate studies on the efficacy and safety of the use of ibrutinib, acalabrutinib and venetoclax in first-line treatment in patients with high-risk CLL. Method:Systematic review of randomized clinical trials that evaluated adult patients with CLL, carriers of 17p deletion or TP53 mutation and without prior treatment. The PubMed, EMBASE, LILACS and Cochrane Library databases were searched, and the risk of bias was assessed using the Cochrane RoB 2 tool and the quality of evidence was assessed with GRADE. Results: In the network meta-analysis for progression-free survival (PFS) venetoclax + obinutuzumab (RR: 0.62; 95%CI 0.41-0.95; p value 0.027) and acalabrutinib + obinutuzumab (RR: 0. 74; 95% CI 0.55-0.99; p value 0.043) presented a lower risk of progression or death, with significance considered borderline. Ibrutinib + obinutuzumab (RR: 0.93; 95% CI 0.86-1.00; p value 0.054) did not show a significant difference in PFS for patients with high-risk CLL. Conclusion: First-line treatment with BTK inhibitors (ibrutinib and acalabrutinib) and the BCL-2 inhibitor (venetoclax) associated with anti-CD20 monoclonal agents ­ especially obinutuzumab ­ have been proposed as the standard for most patients with CLL. However, based on the results of this review with network meta-analysis, it was not possible to confirm this recommendation.

Introducción: Los pacientes con leucemia linfocítica crónica (LLC) de alto riesgo tienen tasas de respuesta más bajas, un curso clínico más agresivo y resistencia a la quimioterapia estándar, lo que representa un desafío para el tratamiento. En estos casos se pueden utilizar los inhibidores de la tirosina quinasa de Bruton (BTK - ibrutinib y acalabrutinib) y el inhibidor de BCL-2 (venetoclax). Objetivo:Identificar y evaluar estudios sobre la eficacia y seguridad del uso de ibrutinib, acalabrutinib y venetoclax en el tratamiento de primera línea en pacientes con LLC de alto riesgo. Método: Revisión sistemática de ensayos clínicos aleatorios que evaluaron pacientes adultos con LLC, portadores de deleción 17p o mutación TP53 y sin tratamiento previo. Se realizaron búsquedas en las bases de datos PubMed, EMBASE, LILACS y Cochrane Library y se evaluó el riesgo de sesgo mediante la herramienta Cochrane RoB 2 y la calidad de la evidencia se evaluó mediante GRADE. Resultados: En el metaanálisis en red para la supervivencia libre de progresión (SSP) venetoclax + obinutuzumab (RR: 0,62; IC 95% 0,41-0,95; valor de p 0,027) y acalabrutinib + obinutuzumab (RR: 0,74; IC 95%). 0,55-0,99; valor de p 0,043) presentaron un menor riesgo de progresión o muerte, con una significación considerada límite. Ibrutinib + obinutuzumab (RR: 0,93; IC del 95 %: 0,86-1,00; valor de p 0,054) no mostró una diferencia significativa en la SSP para pacientes con LLC de alto riesgo. Conclusión: El tratamiento de primera línea con inhibidores de BTK (ibrutinib y acalabrutinib) y el inhibidor de BCL-2 (venetoclax), asociados con agentes monoclonales anti-CD20, especialmente obinutuzumab, se ha propuesto como estándar para la mayoría de los pacientes con LLC. Sin embargo, según los resultados de esta revisión con metaanálisis en red, no fue posible confirmar esta recomendación

Clinical Features and Survival Analysis of Patients after Mechanical Heart Valve Replacement, with an Emphasis on Prosthetic Valve Thrombosis. / Aspectos Clínicos e de Sobrevida de Pacientes pós Implante de Valva Mecânica, com Ênfase em Trombose de Prótese Valvar.

BACKGROUND: Valvular heart diseases are highly prevalent in the world, and surgical valve replacement has improved patients' survival. OBJECTIVES: To describe clinical and laboratory data of patients undergoing mechanical valve replacement, and to determine the incidence of prosthetic valve thrombosis (PVT). METHODS: Retrospective cohort study with a follow-up of up to nine years. The study variables were collected from conventional and electronic medical charts. Statistical calculations were performed using the Jamovi software version 1.2.2.; a p<0.05 was considered statistically significant. Kaplan Meier curves were constructed, and Cox regression analysis was performed for analysis of factors related to mortality. RESULTS: A total of 473 patients were included, mean age of 46.9 ±11.3 years. Rheumatic disease was the most common etiology. In a mean follow-up period of 4.43 years, mortality rate was 16.1%. Patients with aortic prosthesis showed higher survival than patients with double implant (mitral and aortic) (p=0.026). Of the factors adjusted for mortality, only functional class and chronic renal failure showed statistically significant association. The incidence of PVT was 0.24/100 patients/year, and the first event occurred more than 1000 days after the implant. Smoking and pannus formation were significantly associated with PVT. No differences were found in INR variability between patients with and without thrombosis by prosthetic position, but significant differences were found in INR before thrombosis as compared with patients without thrombosis (INR= 2.20 [1.80-2.20] vs. 2.80 [2.20-3.40]; p= 0.040). The incidence of stroke and bleeding was 4.4% and 5.2% respectively. CONCLUSIONS: The study population was young, and rheumatic valve disease was common in this group. The prevalence of PVT was similar to that described in the literature, despite the low income and low educational level of our sample.

FUNDAMENTO: As doenças oro-valvares têm prevalência mundial expressiva, e a cirurgia de troca valvar melhorou a sobrevida dos pacientes. OBJETIVOS: Descrever aspectos clínico-laboratoriais dos pacientes submetidos a implante valvar mecânico e determinar a incidência de trombose de próteses valvares (TPV). MÉTODOS: Estudo de coorte retrospectivo com seguimento até nove anos; as variáveis de estudo foram buscadas em prontuários físicos e eletrônicos. Os cálculos foram realizados pelo programa Jamovi 1.2.2.; p<0,05 foi considerado estatisticamente significante. Foram construídas curvas de Kaplan Meier, e realizada análise de regressão de Cox para fatores relacionados à mortalidade. RESULTADOS: Foram incluídos 473 pacientes com média de idade de 46,9 ±11,3 anos. A doença reumática foi a principal etiologia. Em média de acompanhamento de 4,43 anos, a mortalidade foi de 16,1%. Pacientes com implantes de próteses na posição aórtica tiveram sobrevida melhor que os portadores em posição mitro-aórtica (p=0,026). Entre os fatores ajustados para mortalidade, apenas classe funcional e insuficiência renal crônica apresentaram significância estatística. A incidência de TPV foi de 0,24/100 pacientes/ano, com primeiro evento após 1000 dias da cirurgia. Tabagismo e pannus foram estatisticamente associados a TPV. Não houve diferenças na variabilidade de INR entre pacientes com e sem trombose por posição protética, mas houve diferença estatística no INR pré-evento trombótico comparado aos que não apresentaram trombose (INR= 2,20[1,80-2,20] vs 2,80[2,20-3,40]; p= 0,040). Identificamos 4,4% de acidentes vasculares cerebrais e 5,2% de sangramentos. CONCLUSÕES: A população mostrou-se jovem e valvopatia reumática foi frequente. A frequência de TPV foi semelhante à descrita na literatura, apesar da baixa renda e escolaridade da amostra.

Aspectos Clínicos e de Sobrevida de Pacientes pós Implante de Valva Mecânica, com Ênfase em Trombose de Prótese Valvar / Clinical Features and Survival Analysis of Patients after Mechanical Heart Valve Replacement, with an Emphasis on Prosthetic Valve Thrombosis

Resumo Fundamento As doenças oro-valvares têm prevalência mundial expressiva, e a cirurgia de troca valvar melhorou a sobrevida dos pacientes. Objetivos Descrever aspectos clínico-laboratoriais dos pacientes submetidos a implante valvar mecânico e determinar a incidência de trombose de próteses valvares (TPV). Métodos Estudo de coorte retrospectivo com seguimento até nove anos; as variáveis de estudo foram buscadas em prontuários físicos e eletrônicos. Os cálculos foram realizados pelo programa Jamovi 1.2.2.; p<0,05 foi considerado estatisticamente significante. Foram construídas curvas de Kaplan Meier, e realizada análise de regressão de Cox para fatores relacionados à mortalidade. Resultados Foram incluídos 473 pacientes com média de idade de 46,9 ±11,3 anos. A doença reumática foi a principal etiologia. Em média de acompanhamento de 4,43 anos, a mortalidade foi de 16,1%. Pacientes com implantes de próteses na posição aórtica tiveram sobrevida melhor que os portadores em posição mitro-aórtica (p=0,026). Entre os fatores ajustados para mortalidade, apenas classe funcional e insuficiência renal crônica apresentaram significância estatística. A incidência de TPV foi de 0,24/100 pacientes/ano, com primeiro evento após 1000 dias da cirurgia. Tabagismo e pannus foram estatisticamente associados a TPV. Não houve diferenças na variabilidade de INR entre pacientes com e sem trombose por posição protética, mas houve diferença estatística no INR pré-evento trombótico comparado aos que não apresentaram trombose (INR= 2,20[1,80-2,20] vs 2,80[2,20-3,40]; p= 0,040). Identificamos 4,4% de acidentes vasculares cerebrais e 5,2% de sangramentos. Conclusões A população mostrou-se jovem e valvopatia reumática foi frequente. A frequência de TPV foi semelhante à descrita na literatura, apesar da baixa renda e escolaridade da amostra.

Abstract Background Valvular heart diseases are highly prevalent in the world, and surgical valve replacement has improved patients' survival. Objectives To describe clinical and laboratory data of patients undergoing mechanical valve replacement, and to determine the incidence of prosthetic valve thrombosis (PVT). Methods Retrospective cohort study with a follow-up of up to nine years. The study variables were collected from conventional and electronic medical charts. Statistical calculations were performed using the Jamovi software version 1.2.2.; a p<0.05 was considered statistically significant. Kaplan Meier curves were constructed, and Cox regression analysis was performed for analysis of factors related to mortality. Results A total of 473 patients were included, mean age of 46.9 ±11.3 years. Rheumatic disease was the most common etiology. In a mean follow-up period of 4.43 years, mortality rate was 16.1%. Patients with aortic prosthesis showed higher survival than patients with double implant (mitral and aortic) (p=0.026). Of the factors adjusted for mortality, only functional class and chronic renal failure showed statistically significant association. The incidence of PVT was 0.24/100 patients/year, and the first event occurred more than 1000 days after the implant. Smoking and pannus formation were significantly associated with PVT. No differences were found in INR variability between patients with and without thrombosis by prosthetic position, but significant differences were found in INR before thrombosis as compared with patients without thrombosis (INR= 2.20 [1.80-2.20] vs. 2.80 [2.20-3.40]; p= 0.040). The incidence of stroke and bleeding was 4.4% and 5.2% respectively. Conclusions The study population was young, and rheumatic valve disease was common in this group. The prevalence of PVT was similar to that described in the literature, despite the low income and low educational level of our sample.

COVID-19 in patients with cardiac disease: Impact and variables associated with mortality in a cardiology center in Brazil.

BACKGROUND: Cardiovascular disease is associated with severe COVID-19. Our aim was to describe clinical and laboratory features (including electrocardiographic and echocardiographic ones) and outcomes of patients with cardiac disease hospitalized with COVID-19. METHODS: This is an observational retrospective study of consecutive adult patients admitted, between March and September of 2020, with confirmed SARSCoV-2 infection. Data were collected as per the ISARIC case report form and complemented with variables related to heart disease. RESULTS: One hundred twenty-one patients were included. Mean age was 60 SD 15.2 years and 80/121(66.1%) were male. Two-thirds of the patients (80/121, 66.1%) had COVID-19 at the time of hospital admission and COVID-19 was the reason for hospitalization in 42 (34.7%). Other reasons for hospital admission were acute coronary syndrome (26%) and decompensated heart failure (14.8%). Chronic cardiac diseases were found in 106/121 (87.6%), mostly coronary artery disease (62%) or valve disease (33.9%). A transthoracic echocardiogram was performed in 93/121(76.8%) and enlarged cardiac chambers were found in 71% (66/93); admission ECG was done in 93 cases (93/121, 76.8%), and 89.2% (83/93) were abnormal. Hospital-acquisition of COVID-19 occurred in 20 (16.5%) of patients and their mortality was 50%. On bivariate analysis for mortality, BNP levels and troponin levels were NOT associated with mortality. On multivariate analysis, only C reactive protein levels and creatinine levels were significant. CONCLUSIONS: COVID-19 impacted the profile of hospital admissions in cardiac patients. BNP and troponin levels were not associated with mortality and may not be good prognostic discriminators in cardiac patients.

Effect of Using Triclosan-Impregnated Polyglactin Suture to Prevent Infection of Saphenectomy Wounds in CABG: A Prospective, Double-Blind, Randomized Clinical Trial.

OBJECTIVE: To evaluate the efficacy of triclosan-coated suture for the reduction of infection in saphenectomy wounds of patients undergoing coronary artery bypass graft (CABG) surgery. METHODS: A total of 508 patients who underwent saphenectomy in CABG surgery were included in a prospective, randomized, double-blind trial from February/2011 to June/2014. Patients were randomized into the triclosan-coated suture group (n= 251) and the conventional non-antibiotic suture group (n=257). Demographic (gender and age), clinical (body mass index, diabetes, and use of analgesics), and intraoperative (cardiopulmonary bypass and cross-clamp times) variables and those related to the saphenectomy wound (pain, dehiscence, erythema, infection, necrosis, and hyperthermia) were measured and analyzed. RESULTS: Of the 508 patients who underwent saphenectomy, 69.9% were males and 40.2% were diabetic. Thirty-three (6.5%) patients presented infection: 13 (5.3%) with triclosan and 20 (7.9%) with conventional suture (P=0.281). Among diabetic patients (n=204), triclosan suture was used in 45.1% with four cases of infection; conventional suture was used in 54.9% of them, with 11 cases of infection. Most patients (94.3%) underwent on-pump CABG. Wound pain was observed in 9.9% of patients with triclosan-coated suture and in 17.9% with conventional suture (P=0.011). Wound hyperthermia was found in 1.6% of patients with triclosan-coated suture and in 5.4% of those with conventional suture (P=0.028). CONCLUSION: Triclosan-coated suture shows lower infection rate in saphenectomy of patients undergoing CABG, although the differences were not statistically significant. Pain and wound hyperthermia were less frequent in patients with triclosan-coated sutures compared with conventional sutures.

Effect of using triclosan-impregnated polyglactin suture to prevent infection of saphenectomy wounds in cabg: a prospective, double-blind, randomized clinical trial

Abstract Objective: To evaluate the efficacy of triclosan-coated suture for the reduction of infection in saphenectomy wounds of patients undergoing coronary artery bypass graft (CABG) surgery. Methods: A total of 508 patients who underwent saphenectomy in CABG surgery were included in a prospective, randomized, double-blind trial from February/2011 to June/2014. Patients were randomized into the triclosan-coated suture group (n= 251) and the conventional non-antibiotic suture group (n=257). Demographic (gender and age), clinical (body mass index, diabetes, and use of analgesics), and intraoperative (cardiopulmonary bypass and cross-clamp times) variables and those related to the saphenectomy wound (pain, dehiscence, erythema, infection, necrosis, and hyperthermia) were measured and analyzed. Results: Of the 508 patients who underwent saphenectomy, 69.9% were males and 40.2% were diabetic. Thirty-three (6.5%) patients presented infection: 13 (5.3%) with triclosan and 20 (7.9%) with conventional suture (P=0.281). Among diabetic patients (n=204), triclosan suture was used in 45.1% with four cases of infection; conventional suture was used in 54.9% of them, with 11 cases of infection. Most patients (94.3%) underwent on-pump CABG. Wound pain was observed in 9.9% of patients with triclosan-coated suture and in 17.9% with conventional suture (P=0.011). Wound hyperthermia was found in 1.6% of patients with triclosan-coated suture and in 5.4% of those with conventional suture (P=0.028). Conclusion: Triclosan-coated suture shows lower infection rate in saphenectomy of patients undergoing CABG, although the differences were not statistically significant. Pain and wound hyperthermia were less frequent in patients with triclosan-coated sutures compared with conventional sutures.

Economic burden of diabetes in Brazil in 2014.

BACKGROUND: Diabetes and its complications produce significant clinical, economic and social impact. The knowledge of the costs of diabetes generates subsidies to maintain the financial sustainability of public health and social security systems, guiding research and health care priorities. AIMS: The aim of this study was to estimate the economic burden of diabetes in Brazilian adults in 2014, considering the perspectives of the public health care system and the society. METHODS: A prevalence-based approach was used to estimate the annual health resource utilization and costs attributable to diabetes and related conditions. The healthcare system perspective considered direct medical costs related to outpatient and hospitalization costs. The societal perspective considered non-medical (transportation and dietary products) and indirect costs (productivity loss, disability, and premature retirement). Outpatient costs included medicines, health professional visits, exams, home glucose monitoring, ophthalmic procedures, and costs related to end stage renal disease. The costs of hospitalization attributed to diabetes related conditions were estimated using attributable risk methodology. Costs were estimated in Brazilian currency, and then converted to international dollars (2014). RESULTS: Based on a national self-reported prevalence of 6.2%, the total cost of diabetes in 2014 was Int$ 15.67 billion, including Int$ 6.89 billion in direct medical costs (44%), Int$ 3.69 billion in non-medical costs (23.6%) and Int$ 5.07 billion in indirect costs (32.4%). Outpatient costs summed Int$ 6.62 billion and the costs of 314,334 hospitalizations attributed to diabetes and related conditions was Int$ 264.9 million. Most hospitalizations were due to cardiovascular diseases (47.9%), followed by diabetes itself (18%), and renal diseases (13.6%). Diet and transportation costs were estimated at Int$ 3.2 billion and Int$ 462.3 million, respectively. CONCLUSIONS: Our results showed a substantial economic burden of diabetes in Brazil, and most likely are underrated as they are based on an underestimated prevalence of diabetes. Healthcare policies aiming at diabetes prevention and control are urgently sought.

Cost-Utility of Gastric Bypass Surgery Compared to Clinical Treatment for Severely Obese With and Without Diabetes in the Perspective of the Brazilian Public Health System.

PURPOSE: Obesity is associated with increased morbidity and mortality. Weight loss due to gastric bypass (GBP) surgery improves clinical outcomes and may be a cost-effective intervention. To estimate the cost-effectiveness of GBP compared to clinical treatment in severely obese individuals with and without diabetes in the perspective of the Brazilian public health system. MATERIALS AND METHODS: A Markov model was developed to compare costs and outcomes of gastric bypass in an open approach to clinical treatment. Health states were living with diabetes, remission of diabetes, non-fatal and fatal myocardial infarction, and death. We also included the occurrence of complications related to surgery and plastic surgery after the gastric bypass surgery. The direct costs were obtained from primary data collection performed in three public reference centers for obesity treatment. Utility values also derived from this cohort, while transition probabilities came from the international literature. A sensitivity analysis was performed to evaluate uncertainties. The model considered a 10-year time horizon and a 5% discount rate. RESULTS: Over 10 years, GBP increased quality-adjusted life years (QALY) and costs compared to clinical treatment, resulting in an incremental cost-effectiveness ratio (ICER) of Int$1820.17/QALY and Int$1937.73/QALY in individuals with and without diabetes, respectively. Sensitivity analysis showed that utility values and direct costs of treatments were the parameters that affected the most the ICERs. CONCLUSION: The study demonstrated that GBP is a cost-effective intervention for severely obese individuals in the Brazilian public health system perspective, with a better result in individuals with diabetes.

Early Onset Prosthetic Valve Endocarditis: Experience at a Cardiothoracic Surgical Hospital, 2006-2016.

BACKGROUND: Early onset prosthetic valve endocarditis (EO-PVE) is an serious complication associated with heart valve replacement surgery. OBJECTIVES: To describe the epidemiologic, clinical, and laboratory profile of patients with EO-PVE in a cardiac surgical hospital. PATIENTS AND METHODS: A retrospective analysis of an endocarditis database, implemented prospectively, with a post hoc study driven by analysis of cases of adults with definite endocarditis occurring up to 12 months after heart valve surgery. RESULTS: We identified 26 cases in 2,496 surgeries in the period 2006-2016. The average annual incidence was 1.04%. The median time between valve replacement and the diagnosis of EO-PVE was 33 days (interquartile range [IQR] 19.25-118.75). Biologic and mechanical prostheses were affected in 53.8% and 46.2%, respectively. Rheumatic disease was present in 57.7% of patients. The most common causative pathogens were Staphylococcus epidermidis (23.1%). No Staphylococcus aureus infection was reported. Complications were present in 73.1% of cases, including embolism (65.4%), acute renal failure (38.5%), and heart failure (23.1%). The mortality rate at 30 days and 12 months was 3.8% and 34.6%, respectively. CONCLUSIONS: In our cohort EO-PVE was an serious complication of heart valve replacement with a high morbidity and mortality, despite its low frequency.

Medium-term outcomes of 78,808 patients after heart valve surgery in a middle-income country: a nationwide population-based study.

BACKGROUND: Heart valve surgery outcomes are unknown in middle-income countries and thus cannot be used in health system decision making processes. This study estimated in-hospital mortality and medium and long-term survival. METHODS: This was a retrospective study of 78,806 patients who underwent heart valve surgery between 2001 and 2007 in Brazil. Two national databases were used, the Hospital Information System and the Mortality Information System. Kaplan-Meier survival analysis and log-rank tests were performed. Maximum and median follow-up was 7.7 and 2.8 years, respectively (0.002-7.707). RESULTS: Valve replacement accounted for 69.1% of procedures performed. Mitral stenosis, the most common valve injury, represented 38.9% of the total. In 94.7% of mitral stenosis patients, aetiology was rheumatic heart disease. In-hospital mortality was 7.6% and was higher for women, for patients who had undergone concomitant coronary artery bypass grafting (CABG) and for the elderly. Overall survival was 69.9% at the end of follow-up. Survival was worst among elderly, male and concomitant CABG patients (P<0.001). CONCLUSIONS: Rheumatic heart disease is still a major public health problem in Brazil. In-hospital mortality and global survival rates of patients who have undergone heart valve surgery were less satisfactory than those reported in high-income countries. The findings of this study can contribute to guiding decision making processes in middle-income countries similar to Brazil and others concerned with improving the quality of care.

Estudo dos custos das internações por cardiopatia isquêmica em indivíduos com e sem diabetes mellitus em centro de referência cardiológico do Sistema Único de Saúde brasileiro / Study of costs of admissions for ischemic heart disease in individuals with and without diabetes mellitus in cardiac reference center brazilian Unified Health System

Objetivos: Estimar os custos diretos das internações hospitalares decorrentes de cardiopatia isquê- mica, em pacientes com (DM) e sem diabetes mellitus (NDM). Verificar fatores determinantes de maior custo em ambos os grupos. Métodos: Coorte retrospectiva com 421 pacientes, entre janeiro de 2009 e março de 2010. Foram avaliados: tratamentos clínicos, intervenções hemodinâmicas e cirurgias. Custos obtidos de três formas diferentes: por valores oriundos do Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos e Órteses, Próteses e Materiais Especiais do Sistema Único de Saúde ­ SIGTAP, faturados pela unidade hospitalar, e busca ativa de recursos utilizados pelo paciente, denominado "custos da internação". Os dados foram comparados pelo teste não paramé-trico de Mann-Whitney; p ≤ 0,05 indicou testes estatisticamente significantes; análises realizadas pelo programa R, versão 3.1.0. Resultados: Foram avaliados 421 pacientes, 45,4% eram cardiopatas diabéticos (DM). Não ocorreram diferenças estatisticamente significantes para os valores de custos encontrados em nenhum dos grupos avaliados. Os itens determinantes de maior custo nos procedimentos de cirurgia cardíaca são os materiais e medicamentos que respondem a 41,9% do custo total no grupo DM e 48,4 no grupo NDM. No tratamento clínico são o procedimento de hemodiálise para DM (69,8%) e serviços profissionais para NDM (50,6%). Para intervenções hemodinâmicas, os procedimentos secundários geram maior custo para DM (48,8%) e os serviços profissionais para NDM (75,6%). Conclusões: Não houve impacto financeiro atribuível ao diabetes na internação hospitalar de pacientes cardíacos. Serviços profissionais, materiais e medicamentos, hemodiálise e procedimentos secundários são os determinantes de maior custo nos grupos de intervenções avaliados.

Objectives: Estimate the direct costs in hospital admissions due to ischemic heart disease in two patients groups: with diabetes mellitus (DM) and without diabetes mellitus (NDM). Verify which factors are most relevant for the cost in each group. Methods: Retrospective cohort with 421 patients, between January 2009 and March 2010. We evaluated the clinical treatments, hemodynamic interventions and surgeries. Costs were obtained from three sources: Procedures Table Management System, Drugs and Orthosis, Prosthesis and Material Unified Health System ­ SIGTAP; invoiced by the hospital and active search for resources used by the patient called 'hospitalization costs'. The groups were compared using the Mann-Whitney test; p < 0.05 was considered statistically significant; analyzes conducted on R version 3.1.0 program. Results: We evaluated 421 patients, 45.4% were diabetic heart disease (DM). There were no statistically significant differences in the cost values between the groups. We verified that the relevant factors for higher costs are materials and drugs (DM = 41,9%; NDM = 48,4%) on surgical patients; hemodyalisis procedure for DM group (69,8%) and professional costs for NDM group (50,6%) on clinical treatment patients; secondary procedures for DM group (48,8%) and professional costs for NDM group (75,6%) on hemodynamic interventions patients. Conclusion: There was no differential financial impact attributable to diabetes in hospital cardiac patients. Professional services, material and drugs, hemodyalisis and secondary procedures are the most relevant for higher cost on analysed groups.

Budget impact analysis of the percutaneous septal occluder for treatment of ostium secundum atrial septal defects in the Brazilian Unified National Health System.

The aim of this study was to perform a budget impact analysis on the adoption of percutaneous occlusion of ostium secundum atrial septal defects in the Brazilian Unified National Health System. Costs were collected using micro-costing technique from medical records for each treatment technique (conventional surgery versus percutaneous septal occluder) at a public federal hospital specialized in high-complexity cardiology. The analysis showed that expenditures associated with percutaneous occlusion were lower than with conventional surgery, and sensitivity analysis confirmed the cost reduction in several scenarios, showing a significant budget impact with a 30% adoption rate for the percutaneous occluder (savings of approximately 1.5 million dollars per year). The study indicates that the adoption of the percutaneous septal occluder would mean cost savings of approximately 3.5 million dollars for the Brazilian public health system.

Budget impact analysis of the percutaneous septal occluder for treatment of ostium secundum atrial septal defects in the Brazilian Unified National Health System / Análise do impacto orçamentário do uso de oclusor percutâneo septal para fechamento de comunicação interatrial no Sistema Único de Saúde / Análisis del impacto presupuestario en el uso del oclusor percutáneo septal para la oclusión de comunicación interauricular en el Sistema Único de Salud brasileño

The aim of this study was to perform a budget impact analysis on the adoption of percutaneous occlusion of ostium secundum atrial septal defects in the Brazilian Unified National Health System. Costs were collected using micro-costing technique from medical records for each treatment technique (conventional surgery versus percutaneous septal occluder) at a public federal hospital specialized in high-complexity cardiology. The analysis showed that expenditures associated with percutaneous occlusion were lower than with conventional surgery, and sensitivity analysis confirmed the cost reduction in several scenarios, showing a significant budget impact with a 30% adoption rate for the percutaneous occluder (savings of approximately 1.5 million dollars per year). The study indicates that the adoption of the percutaneous septal occluder would mean cost savings of approximately 3.5 million dollars for the Brazilian public health system.

O objetivo foi analisar o impacto orçamentário da incorporação do oclusor septal percutâneo para o tratamento de defeitos do septo atrial do tipo ostium secundum, sob a perspectiva do Sistema Único de Saúde brasileiro. Os custos foram coletados por microcusteio com base nos registros das intervenções terapêuticas (cirurgia convencional ou implante percutâneo de oclusor septal) realizadas em um hospital público federal especializado em cardiologia de alta complexidade. A análise identificou que os custos associados ao procedimento percutâneo de oclusor septal foram inferiores aos relacionados com a cirurgia convencional, a análise de sensibilidade confirmou a redução dos custos em diversos cenários e mostrou que o impacto no orçamento foi significativo a partir de uma taxa de incorporação de 30% do oclusor septal percutâneo pelo sistema de saúde (redução dos gastos em torno de 1,5 milhão de dólares por ano). O estudo indica que a adoção do implante percutâneo do oclusor septal pode representar uma economia de aproximadamente 3,5 milhões de dólares para o sistema de saúde brasileiro.

El estudio consistió en analizar el impacto presupuestario de la implementación del oclusor septal percutáneo para el tratamiento de defectos del tabique auricular del ostium secundum, desde la perspectiva del Sistema Único de Salud. Los costes incluidos en el modelo por la técnica de micro-coste se obtuvieron de los registros de las intervenciones terapéuticas (cirurgía convencional u oclusor septal percutáneo) en un hospital público federal, especializado en cardiología de alta complejidad. El análisis reveló que los costos asociados con el oclusor septal percutáneo fueron más bajos que los asociados con la cirugía convencional, un análisis de sensibilidad confirmó la reducción de costos en diferentes escenarios y mostró que el impacto fue significativo desde una tasa del 30% de incorporación del oclusor septal percutáneo por el sistema de salud (reducción en el gasto de alrededor de 1.5 millones de dolares por año). El estudio indica que la adopción del implante percutáneo del oclusor septal puede representar un ahorro de aproximadamente 3,5 millones de dólares anuales al sistema de salud brasileño.

Cost-effectiveness of procedures for treatment of ostium secundum atrial septal defects occlusion comparing conventional surgery and septal percutaneous implant.

OBJECTIVES: The study performs a cost-effectiveness analysis of procedures for atrial septal defects occlusion, comparing conventional surgery to septal percutaneous implant. METHODS: A model of analytical decision was structured with symmetric branches to estimate cost-effectiveness ratio between the procedures. The decision tree model was based on evidences gathered through meta-analysis of literature, and validated by a panel of specialists. The lower number of surgical procedures performed for atrial septal defects occlusion at each branch was considered as the effectiveness outcome. Direct medical costs and probabilities for each event were inserted in the model using data available from Brazilian public sector database system and information extracted from the literature review, using micro-costing technique. Sensitivity analysis included price variations of percutaneous implant. RESULTS: The results obtained from the decision model demonstrated that the percutaneous implant was more cost effective in cost-effectiveness analysis at a cost of US$8,936.34 with a reduction in the probability of surgery occurrence in 93% of the cases. Probability of atrial septal communication occlusion and cost of the implant are the determinant factors of cost-effectiveness ratio. CONCLUSIONS: The proposal of a decision model seeks to fill a void in the academic literature. The decision model proposed includes the outcomes that present major impact in relation to the overall costs of the procedure. The atrial septal defects occlusion using percutaneous implant reduces the physical and psychological distress to the patients in relation to the conventional surgery, which represent intangible costs in the context of economic evaluation.

Análise de custo-efetividade do reúso de cateteres de cinecoronariografia sob a perspectiva de uma instituição pública no Município do Rio de Janeiro, Brasil / Cost-effectiveness analysis on the reutilization of coronary artery catheters in a public hospital in Rio de Janeiro, Brazil / Análisis del coste-efectividad en la reutilización de catéteres bajo la perspectiva de una institución pública en la ciudad de Río de Janeiro, Brasil

O objetivo foi comparar a relação de custo-efetividade entre o uso de cateteres cardíacos novos com cateteres reprocessados sob a perspectiva de uma instituição pública federal. Foi elaborado um modelo analítico de decisão elaborado para estimar a razão de custo-efetividade entre duas estratégias de utilização de materiais para cateterismo cardíaco utilizando, como desfecho clínico, a ocorrência de reação pirogênica. Os custos foram estimados por coleta direta nos setores envolvidos e valorados em Real (R$) para o ano de 2012. A árvore de decisão foi construída com as probabilidades de pirogenia descritas em estudo clínico. O custo para o reúso foi de R$ 109,84, e, para cateteres novos, de R$ 283,43. A estratégia de reúso demonstrou ser custo-efetiva, e a razão de custo-efetividade incremental indicou que, para evitar um caso de pirogenia, serão gastos R$ 13.561,75. O estudo aponta o reúso de cateteres como uma estratégia de menor custo comparada ao uso exclusivo de cateteres novos e pode contribuir para a tomada de decisão dos gestores.

The aim of this study was to compare the cost-effectiveness ratio of new versus reprocessed coronary artery catheters in a Federal public hospital. This was an analytical decision-making model prepared to estimate the cost-effectiveness ratio between two strategies in the use of materials in coronary artery catheterization, with pyrogenic reaction as the clinical outcome. Costs were estimated using direct data collection in the respective catheterization services and expressed in Brazilian Reais (R$), with 2012 as the reference year. The decision-making tree was constructed with the probabilities of pyrogenic reaction as described in a clinical trial. The cost per catheter for reuse was R$ 109.84, as compared to R$ 283.43 for a new catheter. The reutilization strategy proved to be cost cost-effective, and the incremental cost-effectiveness ratio indicated that R$ 13,561.75 would be spent to avoid one case of pyrogenic reaction. The study identified reuse of coronary artery catheters as a lower cost strategy compared to the exclusive use of new catheters, thus potentially assisting decision-making by health administrators.

El objetivo fue comparar la relación coste-eficacia en la reutilización de catéteres cardíacos respecto a los nuevos, bajo la perspectiva de un servicio público. Se utilizó un modelo analítico con el objeto de estimar la relación coste-efectividad entre las dos estrategias para el uso de materiales en el cateterismo cardíaco, utilizando la ocurrencia de reacción pirogénica como resultados clínicos. Los costes fueron estimados por la recogida directa en los sectores implicados y se expresan en reales (R$) para el año 2012. Un diagrama de decisiones se construyó con las probabilidades pirogénicas descritas en el estudio clínico. El coste de la reutilización era de R$ 109,84 y de R$ 283,43 por catéteres nuevos. La estrategia de reutilización ha demostrado ser coste-efectiva y la tasa de coste-efectividad incremental indicó que para prevenir un caso pirogénico se gastarían R$ 13,561.75. El estudio demuestra que la reutilización de catéteres es una estrategia de menor coste, en comparación con el uso exclusivo de los nuevos catéteres, y puede contribuir a la toma de decisiones.

[Cost-effectiveness analysis on the reutilization of coronary artery catheters in a public hospital in Rio de Janeiro, Brazil]. / Análise de custo-efetividade do reúso de cateteres de cinecoronariografia sob a perspectiva de uma instituição pública no Município do Rio de Janeiro, Brasil.

The aim of this study was to compare the cost-effectiveness ratio of new versus reprocessed coronary artery catheters in a Federal public hospital. This was an analytical decision-making model prepared to estimate the cost-effectiveness ratio between two strategies in the use of materials in coronary artery catheterization, with pyrogenic reaction as the clinical outcome. Costs were estimated using direct data collection in the respective catheterization services and expressed in Brazilian Reais (R$), with 2012 as the reference year. The decision-making tree was constructed with the probabilities of pyrogenic reaction as described in a clinical trial. The cost per catheter for reuse was R$ 109.84, as compared to R$ 283.43 for a new catheter. The reutilization strategy proved to be cost cost-effective, and the incremental cost-effectiveness ratio indicated that R$ 13,561.75 would be spent to avoid one case of pyrogenic reaction. The study identified reuse of coronary artery catheters as a lower cost strategy compared to the exclusive use of new catheters, thus potentially assisting decision-making by health administrators.