Transcatheter Valve Replacement in Patients with Aortic Valve Stenosis: An Overview of Systematic Reviews and Meta-Analysis with Different Populations. / Implante Valvar Transcateter em Pacientes com Estenose Valvar Aórtica: Uma Overview de Revisões Sistemáticas e Metanálise Incluindo Múltiplas Populações.

BACKGROUND: Randomized controlled trials (RCTs) and observational studies have compared the efficacy and safety of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis. OBJECTIVES: Compare TAVR and SAVR in patients with different surgical risks, population characteristics, and different transcatheter prosthetic valves. METHODS: An overview of systematic reviews (SRs) was conducted following a structured protocol. Results were grouped by surgical risk, population characteristics, and different valves. RCTs in the SRs were reanalyzed through meta-analyses, and the results were summarized using the GRADE method. The adopted level of statistical significance was 5%. RESULTS: Compared to SAVR, patients with high surgical risk using TAVR had a lower risk of (odds ratio, 95% confidence interval, absolute risk difference) atrial fibrillation (AF) (0.5, 0.29-0.86, -106/1000) and life-threatening bleeding (0.29, 0.2-0.42, -215/1000). Patients with intermediate surgical risk had a lower risk of AF (0.27, 0.23-0.33, -255/1000), life-threatening bleeding (0.15, 0.12-0.19, -330/1000), and acute renal failure (ARF) (0.4, 0.26-0.62, -21/1000). Patients with low surgical risk had a lower risk of death (0.58, 0.34-0.97, -16/1000), stroke (0.51, 0.28-0.94, -15/1000), AF (0.16, 0.12-0.2, -295/1000), life-threatening bleeding (0.17, 0.05-0.55, -76/1000), and ARF (0.27, 0.13-0.55, -21/1000), and had a higher risk of permanent pacemaker implantation (PPI) (4.22, 1.27-14.02, 141/1000). Newer generation devices had a lower risk of AF than older generations, and patients using balloon-expandable devices did not experience higher risks of PPI. CONCLUSIONS: This paper provides evidence that patients at low, intermediate, and high surgical risks have better outcomes when treated with TAVR compared with SAVR.

FUNDAMENTO: Ensaios clínicos randomizados (ECRs) e estudos observacionais compararam a eficácia e a segurança do implante valvar transcateter (TAVR) e da substituição cirúrgica da valva aórtica (SAVR) em pacientes com estenose aórtica grave. OBJETIVOS: Comparar TAVR e SAVR em pacientes com diferentes riscos cirúrgicos, características da população e diferentes válvulas protéticas transcateter. MÉTODOS: Uma overview das revisões sistemáticas (RSs) foi realizada seguindo um protocolo estruturado. Os resultados foram agrupados por risco cirúrgico, características da população e diferentes válvulas. Os ECRs foram reanalisados por meio de metanálises nas RSs, e os resultados foram resumidos por meio do método GRADE. O nível de significância estatística adotado foi de 5%. RESULTADOS: Em comparação com a SAVR, os pacientes com alto risco cirúrgico submetidos à TAVR tiveram um risco menor de ( odds ratio , intervalo de confiança de 95%, diferença absoluta de risco) fibrilação atrial (FA) (0,5, 0,29-0,86, -106/1000) e hemorragia com risco à vida (0,29, 0,2-0,42, -215/1000). Pacientes com risco cirúrgico intermediário apresentaram menor risco de FA (0,27, 0,23-0,33, -255/1.000), hemorragia com risco à vida (0,15, 0,12-0,19, -330/1.000) e insuficiência renal aguda (IRA) (0,4, 0,26-0,62, -21/1000). Pacientes com baixo risco cirúrgico tiveram menor risco de morte (0,58, 0,34-0,97, -16/1000), acidente vascular encefálico (AVE) (0,51, 0,28-0,94, -15/1000), FA (0,16, 0,12-0,2, -295/1000), hemorragia com risco à vida (0,17, 0,05-0,55, -76/1000) e IRA (0,27, 0,13-0,55, -21/1000) e tiveram maior risco de implante de marca-passo definitivo (IMD) (4,22, 1,27 -14.02, 141/1000). Os dispositivos de geração mais recente tiveram um risco menor de FA em comparação com as gerações mais antigas, e pacientes usuários de dispositivos expansíveis por balão não apresentaram riscos maiores de IMD. CONCLUSÕES: Este artigo apresenta evidências de que pacientes com risco cirúrgico baixo, intermediário e alto apresentam melhores desfechos quando tratados com TAVR em comparação com a SAVR.

Real-World Populational-Based Quality of Life and Functional Status After Stroke.

OBJECTIVES: This study aimed to describe health-related quality of life (HRQoL) 3 months and 1 year after stroke, compare HRQoL between dependent (modified Rankin scale [mRS] 3-5) and independent (mRS 0-2) patients, and identify factors predictive of poor HRQoL. METHODS: Patients with a first ischemic stroke or intraparenchymal hemorrhage from the Joinville Stroke Registry were analyzed retrospectively. Using the 5-level version of the EuroQol-5D questionnaire, HRQoL was calculated for all patients 3 months and 1 year after stroke, stratified by mRS score (0-2 or 3-5). One-year HRQoL predictors were examined using univariate and multivariate analyses. RESULTS: Three months after a stroke, data from 884 patients were analyzed; 72.8% were categorized as mRS 0-2 and 27.2% as mRS 3-5, and the mean HRQoL was 0.670 ± 0.256. At 1-year follow-up, 705 patients were evaluated; 75% were classified as mRS 0-2 and 25% as mRS 3-5, and the mean HRQoL was 0.71 ± 0.249. An increase in HRQoL was observed between 3 months and 1 year (mean difference 0.024, P < .0001), both in patients with 3-month mRS 0-2 (0.013, P = .027) and mRS 3-5 (0.052, P < .0001). Increasing age, female sex, hypertension, diabetes, and a high mRS were associated with poor HRQoL at 1 year. CONCLUSIONS: This study described the HRQoL after a stroke in a Brazilian population. This analysis shows that the mRS was highly associated with HRQoL after stroke. Age, sex, diabetes, and hypertension were also associated with HRQoL, although not independently of mRS.

Stroke profile and care during the COVID-19 pandemic: What changed and what did not? A prospective cohort from Joinville, Brazil.

Introduction: The COVID-19 pandemic has wrought negative consequences concerning quality of care for stroke patients since its onset. Prospective population-based data about stroke care in the pandemic are limited. This study aims to investigate the impact of COVID-19 pandemic on stroke profile and care in Joinville, Brazil. Methods: A prospective population-based cohort enrolled the first-ever cerebrovascular events in Joinville, Brazil, and a comparative analyzes was conducted between the first 12 months following COVID-19 restrictions (starting March 2020) and the 12 months just before. Patients with transient ischemic attack (TIA) or stroke had their profiles, incidences, subtypes, severity, access to reperfusion therapy, in-hospital stay, complementary investigation, and mortality compared. Results: The profiles of TIA/stroke patients in both periods were similar, with no differences in gender, age, severity, or comorbidities. There was a reduction in incidence of TIA (32.8%; p = 0.003). In both periods, intravenous thrombolysis (IV) and mechanical thrombectomy (MT) rates and intervals from door to IV/MT were similar. Patients with cardioembolic stroke and atrial fibrillation had their in-hospital stay abbreviated. The etiologic investigation was similar before and during the pandemic, but there were increases in cranial tomographies (p = 0.02), transthoracic echocardiograms (p = 0.001), chest X-rays (p < 0.001) and transcranial Doppler ultrasounds (p < 0.001). The number of cranial magnetic resonance imaging decreased in the pandemic. In-hospital mortality did not change. Discussion: The COVID-19 pandemic is associated with a reduction in TIA, without any influence on stroke profile, the quality of stroke care, in-hospital investigation or mortality. Our findings show an effective response by the local stroke care system and offer convincing evidence that interdisciplinary efforts are the ideal approach to avoiding the COVID-19 pandemic's negative effects, even with scarce resources.

Implante Valvar Transcateter em Pacientes com Estenose Valvar Aórtica: Uma Overview de Revisões Sistemáticas e Metanálise Incluindo Múltiplas Populações / Transcatheter Valve Replacement in Patients with Aortic Valve Stenosis: An Overview of Systematic Reviews and Meta-Analysis with Different Populations

Resumo Fundamento Ensaios clínicos randomizados (ECRs) e estudos observacionais compararam a eficácia e a segurança do implante valvar transcateter (TAVR) e da substituição cirúrgica da valva aórtica (SAVR) em pacientes com estenose aórtica grave. Objetivos Comparar TAVR e SAVR em pacientes com diferentes riscos cirúrgicos, características da população e diferentes válvulas protéticas transcateter. Métodos Uma overview das revisões sistemáticas (RSs) foi realizada seguindo um protocolo estruturado. Os resultados foram agrupados por risco cirúrgico, características da população e diferentes válvulas. Os ECRs foram reanalisados por meio de metanálises nas RSs, e os resultados foram resumidos por meio do método GRADE. O nível de significância estatística adotado foi de 5%. Resultados Em comparação com a SAVR, os pacientes com alto risco cirúrgico submetidos à TAVR tiveram um risco menor de ( odds ratio , intervalo de confiança de 95%, diferença absoluta de risco) fibrilação atrial (FA) (0,5, 0,29-0,86, -106/1000) e hemorragia com risco à vida (0,29, 0,2-0,42, -215/1000). Pacientes com risco cirúrgico intermediário apresentaram menor risco de FA (0,27, 0,23-0,33, -255/1.000), hemorragia com risco à vida (0,15, 0,12-0,19, -330/1.000) e insuficiência renal aguda (IRA) (0,4, 0,26-0,62, -21/1000). Pacientes com baixo risco cirúrgico tiveram menor risco de morte (0,58, 0,34-0,97, -16/1000), acidente vascular encefálico (AVE) (0,51, 0,28-0,94, -15/1000), FA (0,16, 0,12-0,2, -295/1000), hemorragia com risco à vida (0,17, 0,05-0,55, -76/1000) e IRA (0,27, 0,13-0,55, -21/1000) e tiveram maior risco de implante de marca-passo definitivo (IMD) (4,22, 1,27 -14.02, 141/1000). Os dispositivos de geração mais recente tiveram um risco menor de FA em comparação com as gerações mais antigas, e pacientes usuários de dispositivos expansíveis por balão não apresentaram riscos maiores de IMD. Conclusões Este artigo apresenta evidências de que pacientes com risco cirúrgico baixo, intermediário e alto apresentam melhores desfechos quando tratados com TAVR em comparação com a SAVR.

Abstract Background Randomized controlled trials (RCTs) and observational studies have compared the efficacy and safety of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis. Objectives Compare TAVR and SAVR in patients with different surgical risks, population characteristics, and different transcatheter prosthetic valves. Methods An overview of systematic reviews (SRs) was conducted following a structured protocol. Results were grouped by surgical risk, population characteristics, and different valves. RCTs in the SRs were reanalyzed through meta-analyses, and the results were summarized using the GRADE method. The adopted level of statistical significance was 5%. Results Compared to SAVR, patients with high surgical risk using TAVR had a lower risk of (odds ratio, 95% confidence interval, absolute risk difference) atrial fibrillation (AF) (0.5, 0.29-0.86, -106/1000) and life-threatening bleeding (0.29, 0.2-0.42, -215/1000). Patients with intermediate surgical risk had a lower risk of AF (0.27, 0.23-0.33, -255/1000), life-threatening bleeding (0.15, 0.12-0.19, -330/1000), and acute renal failure (ARF) (0.4, 0.26-0.62, -21/1000). Patients with low surgical risk had a lower risk of death (0.58, 0.34-0.97, -16/1000), stroke (0.51, 0.28-0.94, -15/1000), AF (0.16, 0.12-0.2, -295/1000), life-threatening bleeding (0.17, 0.05-0.55, -76/1000), and ARF (0.27, 0.13-0.55, -21/1000), and had a higher risk of permanent pacemaker implantation (PPI) (4.22, 1.27-14.02, 141/1000). Newer generation devices had a lower risk of AF than older generations, and patients using balloon-expandable devices did not experience higher risks of PPI. Conclusions This paper provides evidence that patients at low, intermediate, and high surgical risks have better outcomes when treated with TAVR compared with SAVR.

Moving the Brazilian ischaemic stroke pathway to a value-based care: introduction of a risk-adjusted cost estimate model for stroke treatment.

The unsustainable increases in healthcare expenses and waste have motivated the migration of reimbursement strategies from volume to value. Value-based healthcare requires detailed comprehension of cost information at the patient level. This study introduces a clinical risk- and outcome-adjusted cost estimate model for stroke care sustained on time-driven activity-based costing (TDABC). In a cohort and multicentre study, a TDABC tool was developed to evaluate the costs per stroke patient, allowing us to identify and describe differences in cost by clinical risk at hospital arrival, treatment strategies and modified Rankin Score (mRS) at discharge. The clinical risk was confirmed by multivariate analysis and considered patients' National Institute for Health Stroke Scale and age. Descriptive cost analyses were conducted, followed by univariate and multivariate models to evaluate the risk levels, therapies and mRS stratification effect in costs. Then, the risk-adjusted cost estimate model for ischaemic stroke treatment was introduced. All the hospitals collected routine prospective data from consecutive patients admitted with ischaemic stroke diagnosis confirmed. A total of 822 patients were included. The median cost was I$2210 (interquartile range: I$1163-4504). Fifty percent of the patients registered a favourable outcome mRS (0-2), costing less at all risk levels, while patients with the worst mRS (5-6) registered higher costs. Those undergoing mechanical thrombectomy had an incremental cost for all three risk levels, but this difference was lower for high-risk patients. Estimated costs were compared to observed costs per risk group, and there were no significant differences in most groups, validating the risk and outcome-adjusted cost estimate model. By introducing a risk-adjusted cost estimate model, this study elucidates how healthcare delivery systems can generate local cost information to support value-based reimbursement strategies employing the data collection instruments and analysis developed in this study.

Cost-effectiveness of mechanical thrombectomy for acute ischemic stroke in Brazil: Results from the RESILIENT trial.

BACKGROUND: The RESILIENT trial demonstrated the clinical benefit of mechanical thrombectomy in patients presenting acute ischemic stroke secondary to anterior circulation large vessel occlusion in Brazil. AIMS: This economic evaluation aims to assess the cost-utility of mechanical thrombectomy in the RESILIENT trial from a public healthcare perspective. METHODS: A cost-utility analysis was applied to compare mechanical thrombectomy plus standard medical care (n = 78) vs. standard medical care alone (n = 73), from a subset sample of the RESILIENT trial (151 of 221 patients). Real-world direct costs were considered, and utilities were imputed according to the Utility-Weighted modified Rankin Score. A Markov model was structured, and probabilistic and deterministic sensitivity analyses were performed to evaluate the robustness of results. RESULTS: The incremental costs and quality-adjusted life years gained with mechanical thrombectomy plus standard medical care were estimated at Int$ 7440 and 1.04, respectively, compared to standard medical care alone, yielding an incremental cost-effectiveness ratio of Int$ 7153 per quality-adjusted life year. The deterministic sensitivity analysis demonstrated that mRS-6 costs of the first year most affected the incremental cost-effectiveness ratio. After 1000 simulations, most of results were below the cost-effective threshold. CONCLUSIONS: The intervention's clear long-term benefits offset the initially higher costs of mechanical thrombectomy in the Brazilian public healthcare system. Such therapy is likely to be cost-effective and these results were crucial to incorporate mechanical thrombectomy in the Brazilian public stroke centers.

Decrease in Hospital Admissions for Transient Ischemic Attack, Mild, and Moderate Stroke During the COVID-19 Era.

BACKGROUND AND PURPOSE: Since the onset of the coronavirus disease 2019 (COVID-19) pandemic, doctors and public authorities have demonstrated concern about the reduction in quality of care for other health conditions due to social restrictions and lack of resources. Using a population-based stroke registry, we investigated the impact of the onset of the COVID-19 pandemic in stroke admissions in Joinville, Brazil. METHODS: Patients admitted after the onset of COVID-19 restrictions in the city (defined as March 17, 2020) were compared with those admitted in 2019. We analyzed differences between stroke incidence, types, severity, reperfusion therapies, and time from stroke onset to admission. Statistical tests were also performed to compare the 30 days before and after COVID-19 to the same period in 2019. RESULTS: We observed a decrease in total stroke admissions from an average of 12.9/100 000 per month in 2019 to 8.3 after COVID-19 (P=0.0029). When compared with the same period in 2019, there was a 36.4% reduction in stroke admissions. There was no difference in admissions for severe stroke (National Institutes of Health Stroke Scale score >8), intraparenchymal hemorrhage, and subarachnoid hemorrhage. CONCLUSIONS: The onset of COVID-19 was correlated with a reduction in admissions for transient, mild, and moderate strokes. Given the need to prevent the worsening of symptoms and the occurrence of medical complications in these groups, a reorganization of the stroke-care networks is necessary to reduce collateral damage caused by COVID-19.

Improved Outcomes after Reperfusion Therapies for Ischemic Stroke: A "Real-world" Study in a Developing Country.

BACKGROUND: It is unknown if improvements in ischemic stroke (IS) outcomes reported after cerebral reperfusion therapies (CRT) in developed countries are also applicable to the "real world" scenario of low and middle-income countries. We aimed to measure the long-term outcomes of severe IS treated or not with CRT in Brazil. METHODS: Patients from a stroke center of a state-run hospital were included. We compared the survival probability and functional status at 3 and 12 months in patients with severe IS treated or not with CRT. From 2010 to 2011, we performed intravenous reperfusion when patients arrived within 4.5 h time-window (IVT group) and after 2011, mechanical thrombectomy (MT) combined or not with intravenous alteplase (IAT group). Those who arrived >4.5 h in 2010-2011 and >6 h in 2012-2017 did not undergo CRT (NCRT group). RESULTS: From 2010 to 2017, we registered 917 patients: 74% (677/917) in the NCRT group, 19% (178/917) in the IVT group and 7% (62/917) in the IAT group. Compared to the NCRT group, IVT patients had a 28% higher (HR: 0.72; 95% CI 0.53-0.96) 3-month adjusted probability of survival and risk of functional dependence was 19% lower (adjusted RR: 0.81; 95% CI 0.73-0.91). For those who underwent MT, the adjusted probability of survival was 59 % higher (HR: 0.41; 95% CI 0.21-0.77) and the risk of functional dependence was 21% lower (adjusted RR: 0.79; 95% CI 0.66-094). These outcomes remained significantly better throughout the first year. CONCLUSION: CRT led to better outcomes in patients with severe IS in Brazil.

Late nephrologist referral and mortality assotiation in dialytic patients.

INTRODUCTION: Chronic kidney disease is defined by the progressive loss of renal function. Interventions in early stages significantly improve the prognosis of patients with chronic kidney disease, reducing the mortality, and many studies show that early nephrologist referral reduces the mortality rate. OBJECTIVE: To analyze the characteristics of the patients in dialysis and the time between the first consultation in the dialysis clinic and the beginning of the dialytic program. METHODS: It was made a cohort retrospective study with two analysis axis: the social and epidemiological characteristics of the patients in hemodialysis and the time between the first consultation in the clinic and the beginning of the dialytic program. Analytical and descriptive methods where used to compare these data with the early referral and the mortality 12 months after the dialysis onset. RESULTS: One hundred and one patients were analyzed. The mortality rate of the early and lately referred patients was 47.8% and 20.5%, respectively (HR = 2.38; IC = 1.06-5.36; p = 0.035). Concerning the patients which initiated the dialysis with catheter and arteriovenous fistula, the mortality was respectively 51.4% and 10.3% (HR = 4.61; IC = 1,54-13,75; p = 0.006). CONCLUSION: The referral timing was predominantly late. The late referral was associated with a greater mortality. Other variables associated with a greater mortality were age of 70 or more, presence of diabetes and the use of catheter by the dialysis onset.

Encaminhamento tardio ao nefrologista e a associação com mortalidade em pacientes em hemodiálise / Late nephrologist referral and mortality assotiation in dialytic patients

Introdução: A doença renal crônica (DRC) caracteriza-se pela perda progressiva da função renal. Intervenções em estágios iniciais melhoram significativamente o prognóstico dos pacientes com DRC e vários estudos mostram que o encaminhamento precoce (EP) ao nefrologista reduz a taxa de mortalidade. Objetivo: Analisar o perfil dos pacientes em diálise e o tempo transcorrido entre a primeira consulta na unidade de diálise e o início do programa dialítico. Métodos: Foi realizado um estudo de coorte retrospectivo com dois eixos de análise: perfil socioepidemiológico e clínico dos pacientes em hemodiálise e o tempo transcorrido entre a primeira consulta na unidade de diálise e o início do programa dialítico. Utilizaram-se métodos analíticos para comparar estes dados com o EP e com a mortalidade em 12 meses após o início da diálise. Resultados: Foram analisados 111 pacientes. A taxa de mortalidade dos pacientes encaminhados tardiamente e precocemente foi, respectivamente, de 47,8% e 20,5% (razão de risco [HR] = 2,38; intervalo de confiança [IC] = 1,06-5,36; p = 0,035). Os pacientes que iniciaram a diálise por cateter e fístula arteriovenosa (FAV) tiveram mortalidade, respectivamente, de 51,4% e 10,3% (HR = 4,61; IC = 1,54-13,75; p = 0,006). Conclusão: O tempo de encaminhamento foi predominantemente tardio. Foi demonstrado que o encaminhamento tardio (ET) esteve relacionado a maior mortalidade. Outros fatores associados a maior mortalidade foram a idade maior ou igual a 70 anos, presença de DM e uso de cateter ao início da diálise. .

Introduction: Chronic kidney disease is defined by the progressive loss of renal function. Interventions in early stages significantly improve the prognosis of patients with chronic kidney disease, reducing the mortality, and many studies show that early nephrologist referral reduces the mortality rate. Objective: To analyze the characteristics of the patients in dialysis and the time between the first consultation in the dialysis clinic and the beginning of the dialytic program. Methods: It was made a cohort retrospective study with two analysis axis: the social and epidemiological characteristics of the patients in hemodialysis and the time between the first consultation in the clinic and the beginning of the dialytic program. Analytical and descriptive methods where used to compare these data with the early referral and the mortality 12 months after the dialysis onset. Results: One hundred and one patients were analized. The mortality rate of the early and lately referred patients was 47.8% and 20.5%, respectively (HR = 2.38; IC = 1.06-5.36; p = 0.035). Concerning the patients which initiated the dialysis with catheter and arteriovenous fistula, the mortality was respectively 51.4% and 10.3% (HR = 4.61; IC = 1,54-13,75; p = 0.006). Conclusion: The referral timing was predominantly late. The late referral was associated with a greater mortality. Other variables associated with a greater mortality were age of 70 or more, presence of diabetes and the use of catheter by the dialysis onset. .