Tratamento das cardiopatias congênitas em Sergipe: proposta de racionalização dos recursos para melhorar a assistência Heart defects treatment in Sergipe: propose of resources' rationalization to improve care

OBJETIVO: Avaliar o tratamento das cardiopatias congênitas realizadas de 2000 a 2009. MÉTODOS: A amostra constituiu-se de todos os pacientes submetidos a correção cirúrgica para cardiopatias congênitas por dez anos em Sergipe, Brasil. Os pacientes foram operados em três hospitais localizados na cidade de Aracaju (SE, Brasil), capital do estado de Sergipe. O estudo foi dividido em dois períodos, definidos pela data do início da centralização das cirurgias. As variáveis coletadas foram: faixa etária, gênero, diagnóstico pós-operatório, destino, tipo de cirurgia e hospital em que foi realizado o procedimento e a classificação RACHS -1. RESULTADOS: No período I, a estimativa do déficit de cirurgia foi de 69%, ocorrendo decréscimo no período II para 55,3%. O diagnóstico pós-operatório mais frequente foi de fechamento de comunicação interventricular (20,5%), fechamento de canal arterial (20,2%) e da comunicação interatrial (19%). Houve correlação estatisticamente significativa entre mortalidade esperada pelo RACHS-1 e a observada na amostra. A avaliação do RACHS-1 como fator preditor da mortalidade hospitalar por meio da curva ROC demonstrou área de 0,860 IC 95% 0,818 a 0,902, com P < 0,0001. CONCLUSÃO: Os resultados deste estudo indicam que a centralização e a organização dos recursos existentes são necessárias para melhora no desempenho das correções cirúrgicas das cardiopatias congênitas.<br>OBJECTIVE: This study aims evaluate the treatment of congenital heart disease conducted from 2000 to 2009. METHODS: The sample consisted of all patients undergoing surgical correction for congenital heart disease for ten years in Sergipe, Brazil. The patients were operated in three hospitals located in the city of Aracaju, capital of the state of Sergipe (Brazil). The study was divided into two periods defined by the start date of centralization of surgery. The variables collected were: age, sex, postoperative diagnosis, destination, type of surgery and hospital where the procedure was performed and the classification RACHS -1. RESULTS: In the period I, the estimate deficit of surgery was 69% decrease occurring in the period II to 55.3%. The postoperative diagnosis was more frequent closure of the interventricular communication (20.5%), closure of patent ductus arteriosus (20.2%) and atrial septal defect (19%). There was a statistically significant correlation between the expected mortality RACHS-1 and observed in the sample. The evaluation of RACHS-1 as a predictor of hospital mortality by ROC curve showed area of 0.860 95% CI 0.818 to 0.902 with P <0.0001. CONCLUSION: The results of this study indicate that the centralization and organization of existing resources are needed to improve the performance of surgical correction of congenital heart diseases

Efficacy and safety of available treatments for visceral leishmaniasis in Brazil: A multicenter, randomized, open label trial

<div><p>Background</p><p>There is insufficient evidence to support visceral leishmaniasis (VL) treatment recommendations in Brazil and an urgent need to improve current treatments. Drug combinations may be an option.</p><p>Methods</p><p>A multicenter, randomized, open label, controlled trial was conducted in five sites in Brazil to evaluate efficacy and safety of (i) amphotericin B deoxycholate (AmphoB) (1 mg/kg/day for 14 days), (ii) liposomal amphotericin B (LAMB) (3 mg/kg/day for 7 days) and (iii) a combination of LAMB (10 mg/kg single dose) plus meglumine antimoniate (MA) (20 mg Sb⁺⁵/kg/day for 10 days), compared to (iv) standard treatment with MA (20 mg Sb⁺⁵/kg/day for 20 days). Patients, aged 6 months to 50 years, with confirmed VL and without HIV infection were enrolled in the study. Primary efficacy endpoint was clinical cure at 6 months. A planned efficacy and safety interim analysis led to trial interruption.</p><p>Results</p><p>378 patients were randomized to the four treatment arms<b>:</b> MA (n = 112), AmphoB (n = 45), LAMB (n = 109), or LAMB plus MA (n = 112). A high toxicity of AmphoB prompted an unplanned interim safety analysis and this treatment arm was dropped. Per intention-to-treat protocol final analyses of the remaining 332 patients show cure rates at 6 months of 77.5% for MA, 87.2% for LAMB, and 83.9% for LAMB plus MA, without statistically significant differences between the experimental arms and comparator (LAMB: 9.7%; CI95% -0.28 to 19.68, p = 0.06; LAMB plus MA: 6.4%; CI95% -3.93 to 16.73; p = 0.222). LAMB monotherapy was safer than MA regarding frequency of treatment-related adverse events (AE) (p = 0.045), proportion of patients presenting at least one severe AE (p = 0.029), and the proportion of AEs resulting in definitive treatment discontinuation (p = 0.003).</p><p>Conclusions</p><p>Due to lower toxicity and acceptable efficacy, LAMB would be a more suitable first line treatment for VL than standard treatment. ClinicalTrials.gov identification number: NCT01310738.</p><p>Trial registration</p><p>ClinicalTrials.gov <a href="https://clinicaltrials.gov/ct2/show/NCT01310738" target="_blank">NCT01310738</a></p></div

Survival time until fever clearance.

<p>Survival time until fever clearance per treatment arm by the Kaplan Meier method. MA = meglumine antimoniate; LAMB = Liposomal amphotericin B.</p

CONSORT patient flowchart.

<p>Flow diagram of the progress through the phases of the trial. AmphoB = amphotericin B deoxycholate; MA = meglumine antimoniate; LAMB = Liposomal amphotericin B.</p

Frequency of AE and SAE related to study medication, and temporary and definitive treatment suspension due to the occurrence of AE per intervention arm.

<p>Frequency of AE and SAE related to study medication, and temporary and definitive treatment suspension due to the occurrence of AE per intervention arm.</p

Proportion of participants presenting at least one related AE, SAE and AE grade 3 and 4 per intervention arm.

<p>Proportion of participants presenting at least one related AE, SAE and AE grade 3 and 4 per intervention arm.</p

Early withdrawal rate due to the occurrence of AE/SAE during treatment as per ITT.

<p>Early withdrawal rate due to the occurrence of AE/SAE during treatment as per ITT.</p

Treatment efficacy at six months follow-up as PP approach.

<p>Treatment efficacy at six months follow-up as PP approach.</p