Clinical Outcomes and Cost-Effectiveness Analysis of FFR Compared with Angiography in Multivessel Disease Patient / Impacto Clínico e Custo-Efetividade da FFR em Comparação à Angiografia em Pacientes com Doenças Multiarteriais Submetidos à ICP

Abstract Background: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). Objectives: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. Methods: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. Results: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. Conclusion: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.

Resumo Fundamentos: Em pacientes multiarteriais e lesões moderadas, a reserva de fluxo fracionada (FFR) avalia cada lesão e direciona o tratamento, podendo ser útil no custo-efetividade (CE) de implante de stents não farmacológicos (SNF). Objetivos: Avaliar CE e impacto clínico da angioplastia + FFR versus angioplastia + angiografia (ANGIO), em multiarteriais, utilizando SNF. Métodos: pacientes com doença multiarteriais foram randomizados prospectivamente durante ±5 anos para FFR ou ANGIO, e acompanhados por até 12 meses. Foram avaliados eventos cardíacos maiores (ECAM), reestenose e CE. Resultados: foram incluídos 69 pacientes, 47(68,1%) homens, 34(49,2%) no FFR e 35(50,7%) no ANGIO, idade 62,0 ± 9,0 anos, com angina estável e Síndrome Coronariana Aguda estabilizada. No FFR, havia 26 com doença (76,5%) biarterial e 8 (23,5%) triarterial, e no grupo ANGIO, 24(68,6%) biarteriais e 11(31,4%) triarteriais. Ocorreram 12(17,3%) ECAM - 3(4,3%) óbitos: 2(5,8%) no FFR e 1(2,8%) no ANGIO, 9(13,0%) anginas, 4(11,7%) no FFR e 5(14,2%) no ANGIO, 6 reestenoses: 2(5,8%) no FFR e 4 (11,4%) no ANGIO. Angiografia detectou 87(53,0%) lesões no FFR, 39(23,7%) com ICP e 48(29,3%) com tratamento clínico; e 77(47,0%) lesões no ANGIO, todas submetidas à angioplastia. Quanto aos stents, registrou-se 39(33,3%) (0,45 ± 0,50 stents/lesão) no FFR e 78(66,6%) (1,05 ± 0,22 stents/lesão) no ANGIO (p = 0,0001); ANGIO utilizou 51,4% a mais que o FFR. Análise de CE revelou um custo de R$5045,97 e R$5.430,60 nos grupos ANGIO e FFR, respectivamente. A diferença de efetividade foi 1,82%. Conclusões: FFR diminuiu o número de lesões tratadas e de stents e necessidade de revascularização do vaso-alvo, com CE comparável ao da angiografia.

Clinical Outcomes and Cost-Effectiveness Analysis of FFR Compared with Angiography in Multivessel Disease Patient.

BACKGROUND: In multivessel disease patients with moderate stenosis, fractional flow reserve (FFR) allows the analysis of the lesions and guides treatment, and could contribute to the cost-effectiveness (CE) of non-pharmacological stents (NPS). OBJECTIVES: To evaluate CE and clinical impact of FFR-guided versus angiography-guided angioplasty (ANGIO) in multivessel patients using NPS. METHODS: Multivessel disease patients were prospectively randomized to FFR or ANGIO groups during a 5 year-period and followed for < 12 months. Outcomes measures were major adverse cardiac events (MACE), restenosis and CE. RESULTS: We studied 69 patients, 47 (68.1%) men, aged 62.0 ± 9.0 years, 34 (49.2%) in FFR group and 53 (50.7%) in ANGIO group, with stable angina or acute coronary syndrome. In FFR, there were 26 patients with biarterial disease (76.5%) and 8 (23.5%) with triarterial disease, and in ANGIO, 24 (68.6%) with biarterial and 11 (31.4%) with triarterial disease. Twelve MACEs were observed - 3 deaths: 2 (5.8%) in FFR and 1 (2.8%) in ANGIO, 9 (13.0%) angina: 4(11.7%) in FFR and 5(14.2%) in ANGIO, 6 restenosis: 2(5.8%) in FFR and 4 (11.4%) in ANGIO. Angiography detected 87(53.0%) lesions in FFR, 39(23.7%) with PCI and 48(29.3%) with medical treatment; and 77 (47.0%) lesions in ANGIO, all treated with angioplasty. Thirty-nine (33.3%) stents were registered in FFR (0.45 ± 0.50 stents/lesion) and 78 (1.05 ± 0.22 stents/lesion) in ANGIO (p = 0.0001), 51.4% greater in ANGIO than FFR. CE analysis revealed a cost of BRL 5,045.97 BRL 5,430.60 in ANGIO and FFR, respectively. The difference of effectiveness was of 1.82%. CONCLUSION: FFR reduced the number of lesions treated and stents, and the need for target-lesion revascularization, with a CE comparable with that of angiography.

Estimated costs of hospitalization due to coronary artery disease attributable to familial hypercholesterolemia in the Brazilian public health system.

OBJECTIVE: Cardiovascular diseases are the leading cause of death in Brazil, imposing substantial economic burden on the health care system. Familial hypercholesterolemia (FH) is known to greatly increase the risk of premature coronary artery disease (CAD). This study aimed to estimate the economic impact of hospitalizations due to CAD attributable to FH in the Brazilian Unified Health Care System (SUS). SUBJECTS AND METHODS: Retrospective, cross-sectional study of data obtained from the Hospital Information System of the SUS (SIHSUS). We selected all adults (≥ 20 years of age) hospitalized from 2012--2014 with primary diagnoses related to CAD (ICD-10 I20 to I25). Attributable risk methodology estimated the contribution of FH in the outcomes of interest, using international data for prevalence (0.4% and 0.73%) and relative risk for events (RR = 8.56). RESULTS: Assuming an international prevalence of FH of 0.4% and 0.73%, of the 245,981 CAD admissions/year in Brazil, approximately 7,249 and 12,915, respectively, would be attributable to an underlying diagnosis --of FH. The total cost due to CAD per year, considering both sexes and all adults, was R$ 985,919,064, of which R$ 29,053,500 and R$ 51,764,175, respectively, were estimated to be attributable to FH. The average cost per FH-related CAD event was R$ 4,008. CONCLUSION: Based on estimated costs of hospitalization for CAD, we estimated that 2.9-5.3% are directed to FH patients. FH can require early specific therapies to lower risk in families. It is mandatory to determine the prevalence of FH and institute appropriate treatment to minimize the clinical and economic impact of this disease in Brazil.

Estimated costs of hospitalization due to coronary artery disease attributable to familial hypercholesterolemia in the Brazilian public health system

ABSTRACT Objective: Cardiovascular diseases are the leading cause of death in Brazil, imposing substantial economic burden on the health care system. Familial hypercholesterolemia (FH) is known to greatly increase the risk of premature coronary artery disease (CAD). This study aimed to estimate the economic impact of hospitalizations due to CAD attributable to FH in the Brazilian Unified Health Care System (SUS). Subjects and methods: Retrospective, cross-sectional study of data obtained from the Hospital Information System of the SUS (SIHSUS). We selected all adults (≥ 20 years of age) hospitalized from 2012­-2014 with primary diagnoses related to CAD (ICD-10 I20 to I25). Attributable risk methodology estimated the contribution of FH in the outcomes of interest, using international data for prevalence (0.4% and 0.73%) and relative risk for events (RR = 8.56). Results: Assuming an international prevalence of FH of 0.4% and 0.73%, of the 245,981 CAD admissions/year in Brazil, approximately 7,249 and 12,915, respectively, would be attributable to an underlying diagnosis ­­of FH. The total cost due to CAD per year, considering both sexes and all adults, was R$ 985,919,064, of which R$ 29,053,500 and R$ 51,764,175, respectively, were estimated to be attributable to FH. The average cost per FH-related CAD event was R$ 4,008. Conclusion: Based on estimated costs of hospitalization for CAD, we estimated that 2.9-5.3% are directed to FH patients. FH can require early specific therapies to lower risk in families. It is mandatory to determine the prevalence of FH and institute appropriate treatment to minimize the clinical and economic impact of this disease in Brazil.

Estudo por analisador de gases do Teste de Caminhada de seis minutos na insuficiência cardíaca com fração de ejeção normal / Study with a portable gas analyzer of the 6-minutes walk test in heart failure with normal ejection fraction

Background: Few studies have used portable gas analyzers during the 6-minute walk test (6MWT) in patients with heart failure and normal ejection fraction (HFNEF). Objectives: To analyze the kinetics of hemodynamic, ventilatory, and metabolic variables in patients with HFNEF during the T6m using a portable gas analyzer. Methods: Prospective, analytical study with an intentional, non-probabilistic, convenience sample. In total, 24 patients with HFNEF and past hospital admissions due to a clinical diagnosis of heart failure (HF) were included using the 2007 criteria established by the European Society of Cardiology. Three assessments were performed: 6MWT familiarization, 6MWT with the portable gas analyzer, and cardiopulmonary exercise test (CPET). Results: The heart rates (HRs) and the peak VO 2 at the end of the 6MWT corresponded to 85.7% and 86.45% of the values obtained during the CPET. The final HRs after the T6m were equivalent to those obtained at the CPET anaerobic threshold (AT), with relative VO 2 values at the end of the 6MWT above the VO 2 of the CPET AT. There was no difference between the maximum respiratory quotient (RQ) values in these two tests, which were both above 1.0. The VE/VO 2 slope descended initially and then ascended significantly after the fifth minute of the test, estimating the identification of the AT. Conclusions: In patients with HFNEF, the 6MWT represents an almost maximum effort, and is performed above the CPET AT and 85% above the maximum HR and the CPET peak VO 2 , with a maximum RQ similar to that in the CPET

Fundamentos: Poucos estudos utilizaram analisadores de gases portáteis no teste da caminhada de seis minutos (T6m) em portadores de insuficiência cardíaca com fração de ejeção normal (ICFEN). Objetivos: Analisar a cinética das variáveis hemodinâmicas, ventilatórias e metabólicas utilizando analisador de gases portátil em portadores de ICFEN durante o T6m. Métodos: Estudo prospectivo, analítico, com amostra não probabilística, intencional e por conveniência. Foram estudados 24 pacientes portadores de ICFEN com passado de internação por clínica de insuficiência cardíaca (IC), incluídos pelos critérios da European Society of Cardiology 2007. Realizaram-se três avaliações: T6m de aprendizado, T6m com o analisador de gases portátil e teste de esforço cardiopulmonar (TECP). Resultados: As frequências cardíacas (FC) e o consumo de oxigênio (VO 2 ) pico ao final do T6m corresponderam a 85,7% e 86,45% dos valores obtidos no TECP. As FC finais no T6m foram equivalentes às obtidas no limiar anaeróbio (LA) do TECP, com valores de VO 2 relativo ao final do T6m acima do VO 2 no LA do TECP. Não houve diferença entre os valores máximos do quociente respiratório (QR) entre os dois testes, ambos acima de 1,0. A curva de VE/VO 2 demonstrou descenso com posterior ascensão significativa após o quinto minuto de teste, estimando-se a identificação do LA. Conclusões: Para pacientes com ICFEN, o T6m representa um esforço quase máximo, sendo executado acima do LA do TECP e acima dos 85% da FC máxima e do VO 2 pico do TECP, com QR máximo semelhante ao do TECP

Disease and Economic Burden of Hospitalizations Attributable to Diabetes Mellitus and Its Complications: A Nationwide Study in Brazil.

Diabetes is associated with a significant burden globally. The costs of diabetes-related hospitalizations are unknown in most developing countries. The aim of this study was to estimate the total number and economic burden of hospitalizations attributable to diabetes mellitus (DM) and its complications in adults from the perspective of the Brazilian Public Health System in 2014. Data sources included the National Health Survey (NHS) and National database of Hospitalizations (SIH). We considered diabetes, its microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular complications (coronary heart disease, cerebrovascular disease, and peripheral arterial disease), respiratory and urinary tract infections, as well as selected cancers. Assuming that DM patients are hospitalized for these conditions more frequently that non-DM individuals, we estimated the etiological fraction of each condition related to DM, using the attributable risk methodology. We present number, average cost per case, and overall costs of hospitalizations attributable to DM in Brazil in 2014, stratified by condition, state of the country, gender and age group. In 2014, a total of 313,273 hospitalizations due to diabetes in adults were reported in Brazil (4.6% of total adult hospitalization), totaling (international dollar) Int$264.9 million. The average cost of an adult hospitalization due to diabetes was Int$845, 19% higher than hospitalization without DM. Hospitalizations due to cardiovascular diseases related to diabetes accounted for the higher proportion of costs (47.9%), followed by microvascular complications (25.4%) and DM per se (18.1%). Understanding the costs of diabetes and its major complications is crucial to raise awareness and to support the decision-making process on policy implementation, also allowing the assessment of prevention and control strategies.

Indirect and direct costs of treating patients with ankylosing spondylitis in the Brazilian public health system.

INTRODUCTION: Patients with ankylosing spondylitis require a team approach from multiple professionals, various treatment modalities for continuous periods of time, and can lead to the loss of labour capacity in a young population. So, it is necessary to measure its socio-economic impact. OBJECTIVES: To describe the use of public resources to treat AS in a tertiary hospital after the use of biological medications was approved for treating spondyloarthritis in the Health Public System, establishing approximate values for the direct and indirect costs of treating this illness in Brazil. MATERIAL AND METHODS: 93 patients selected from the ambulatory spondyloarthritis clinic at the Hospital de Clínicas of the Federal University of Paraná between September 2011 and September 2012 had their direct costs indirect treatment costs estimation. RESULTS: 70 patients (75.28%) were male and 23 (24.72%) female. The mean age was 43.95 years. The disease duration was calculated based on the age of diagnosis and the mean was 8.92 years (standard deviation: 7.32); 63.44% were using anti-tumour necrotic factor drugs. Comparing male and female patients the mean Bath Ankylosing Spondylitis Disease Activity Index was 4.64 and 5.49 while the mean Bath Ankylosing Spondylitis Functional Index was 5.03 and 6.35 respectively. CONCLUSIONS: The Brazilian public health system's spending related to ankylosing spondylitis has increased in recent years. An important part of these costs is due to the introduction of new, more expensive health technologies, as in the case of nuclear magnetic resonance and, mainly, the incorporation of anti-tumour necrotic factor therapy into the therapeutic arsenal. The mean annual direct and indirect cost to the Brazilian public health system to treat a patient with ankylosing spondylitis, according to our findings, is US$ 23,183.56.

Indirect and direct costs of treating patients with ankylosing spondylitis in the Brazilian public health system / Custos diretos e indiretos do tratamento de pacientes com espondilite anquilosante pelo sistema público de saúde brasileiro

ABSTRACT Introduction: Patients with Ankylosing Spondylitis (AS) require a team approach from multiple professionals, various treatment modalities for continuous periods of time, and can lead to the loss of labour capacity in a young population. So, it is necessary to measure its socio-economic impact. Objectives: To describe the use of public resources to treat AS in a tertiary hospital after the use of biological medications was approved for treating spondyloarthritis in the Health Public System, establishing approximate values for the direct and indirect costs of treating this illness in Brazil. Material and methods: 93 patients selected from the ambulatory spondyloarthritis clinic at the Hospital de Clínicas of the Federal University of Paraná between September 2011 and September 2012 had their direct costs indirect treatment costs estimation. Results: 70 patients (75.28%) were male and 23 (24.72%) female. The mean age was 43.95 years. The disease duration was calculated based on the age of diagnosis and the mean was 8.92 years (standard deviation: 7.32); 63.44% were using anti-TNF drugs. Comparing male and female patients the mean BASDAI was 4.64 and 5.49 while the mean BASFI was 5.03 and 6.35 respectively. Conclusions: The Brazilian public health system's spending related to ankylosing spondylitis has increased in recent years. An important part of these costs is due to the introduction of new, more expensive health technologies, as in the case of nuclear magnetic resonance and, mainly, the incorporation of anti-TNF therapy into the therapeutic arsenal. The mean annual direct and indirect cost to the Brazilian public health system to treat a patient with ankylosing spondylitis, according to our findings, is US$ 23,183.56.

RESUMO Introdução: Os pacientes com espondilite anquilosante (EA) exigem uma abordagem de equipe com vários profissionais e várias modalidades de tratamento, continuamente; além disso, a doença pode levar à perda da capacidade de trabalho em uma população jovem, de modo que é necessário medir o seu impacto socioeconômico. Objetivos: Descrever o uso de recursos públicos para o tratamento da EA em um hospital terciário após o uso dos fármacos biológicos ter sido aprovado para o tratamento das espondiloartrites pelo Sistema Público de Saúde e estabelecer valores aproximados para os custos diretos e indiretos do tratamento dessa doença no Brasil. Material e métodos: Foram estimados os custos de tratamento diretos e indiretos de 93 pacientes com EA do ambulatório de espondiloartrite do Hospital de Clínicas da Universidade Federal do Paraná, entre setembro de 2011 e setembro 2012. Resultados: Dos pacientes, 70 (75,28%) eram do sexo masculino e 23 (24,72%) do feminino. A idade média foi de 43,95 anos. A duração da doença foi calculada com base na idade do diagnóstico e a média foi de 8,92 anos (desvio padrão: 7,32); 63,44% dos indivíduos usavam fármacos anti-TNF. Na comparação dos pacientes dos sexos masculino e feminino, a média no Bath Ankylosing Spondylitis Disease Activity Index (Basdai) foi de 4,64 e 5,49, enquanto a média no Bath Ankylosing Spondylitis Functional Index (Basfi) foi de 5,03 e 6,35, respectivamente. Conclusões: Os gastos do sistema público de saúde brasileiro relacionados com a espondilite anquilosante aumentaram nos últimos anos. Uma parte importante desses custos deve-se à introdução das novas tecnologias de saúde, mais dispendiosas, como no caso da ressonância nuclear magnética e, principalmente, da incorporação da terapia anti-TNF ao arsenal terapêutico. O custo médio anual direto e indireto do sistema público de saúde brasileiro para tratar de um paciente com espondilite anquilosante, de acordo com os resultados deste estudo, é de US$ 23.183,56.

Asthma and the socio-economic reality in Brazil.

BACKGROUND: Asthma is a prevalent disease that is considered a health problem worldwide. The aim of this study was to analyze the clinical and socioeconomic characteristics of a cohort of asthmatics receiving specialized outpatient treatment in a tertiary/teaching public hospital in Brazil. METHODS: Persistent asthmatics older than 5 years old were consecutively included. They received clinical treatment at 3- to 4-month intervals and were interviewed 2 times at 6-month intervals over a 12-month observation period. The data were collected directly from the patients or their parents by 2 researchers who did not participate in their clinical care. The primary variables were age, gender, education level, monthly family income, place of residence, number of lost days of school or work, BMI, the severity and control level of asthma, the number of scheduled and non-scheduled visits and hospitalization days and the best peak-flow measurement. RESULTS: Of the 117 participants, 108 completed the study. Of the participants, 73.8% were women, and 25.0% lived outside the county. Of those who lived within the county, 60.1% lived in areas far from the health care unit. The majority (83.3%) had associated rhinitis, and more than 50.0% were overweight or obese, in whom the prevalence of severe asthma was greater (p = 0.001). The median monthly income was US$ 536.58 and was greater among the patients with controlled asthma (p = 0.005 and p = 0.01 at the start and the end of the study, respectively). In the initial evaluation, 16 participants had severe asthma, and in the final evaluation, 8 out of 21 patients with uncontrolled asthma had improved. Three-quarters of the students and half of the workers had missed days of school or work, respectively. The asthmatic population in this study had medium to low socioeconomic status in Brazil and socioeconomic status was associated with overweigth/obesity and with poor control of asthma. CONCLUSION: Asthma has a great impact on absenteeism in Brazil. Lower monthly family income and body weight above the ideal level were associated with greater severity and worse control of asthma.