Abstract Objective: Midline sternotomy is the preferred approach for device migration following transcatheter device closure of ostium secundum atrial septal defect. Results of patients operated for device migration were retrospectively reviewed after transcatheter closure of atrial septal defect. Methods: Among the 643 patients who underwent atrial septal defect with closure device, 15 (2.3%) patients were referred for device retrieval and surgical closure of atrial septal defect. Twelve patients underwent device retrieval and surgical closure of atrial septal defect through right antero-lateral minithoracotomy with femoral cannulation. Three patients were operated through midline sternotomy. Results: Twelve patients operated through minithoracotomy did not require conversion to sternotomy. Due to device migration to site of difficult access through thoracotomy, cardiac tamponade and hemodynamic instability, respectively, three patients were operated through midline sternotomy. Mean aortic cross-clamp time and cardiopulmonary bypass time were 28.1±17.7 and 58.3±20.4 minutes, respectively. No patient had surgical complication or mortality. Mean intensive care unit and hospital stay were 1.6±0.5 days and 7.1±2.2 days, respectively. Postoperative echocardiography confirmed absence of any residual defect and ventricular dysfunction. In a mean follow-up period of six months, no mortality was observed. All patients were in New York Heart Association class I without wound or vascular complication. Conclusion: Minithoracotomy with femoral cannulation for cardiopulmonary bypass is a safe-approach for selected group of patients with device migration following transcatheter device closure of atrial septal defect without increasing the risk of cardiac, vascular or neurological complications and with good cosmetic and surgical results.

Resumo Objetivo: A vigilância da intussuscepção foi iniciada após a introdução da vacina monovalente viva atenuada contra rotavírus (RV1) em todo o país. O objetivo é avaliar a epidemiologia da intussuscepção e comparar a quantidade de casos antes e depois da introdução da vacina contra rotavírus. Métodos: Os casos de intussuscepção entre março de 2006 e janeiro de 2008 foram identificados por meio de um sistema de vigilância passivo prospectivo aprimorado estabelecido em hospitais-sentinela estaduais. A análise retrospectiva de prontuários médicos foi usada para identificar os casos que ocorreram em hospitais-sentinela entre janeiro de 2001 e fevereiro de 2006. Resultados: De 2001-2008, identificamos 331 casos de intussuscepção, 59,5% dos quais ocorreram em pacientes do sexo masculino, com pico de incidência entre aqueles com 18-24 semanas de idade. Em geral, < 10% dos casos ocorreram entre neonatos com 6-14 semanas de idade (quando a 1a dose de RV1 é administrada). Os sinais ou sintomas de intussuscepção observados com mais frequência incluíam vômito (89,4%), fezes com sangue (75,5%) e distensão abdominal (71,8%). A maioria (92,1%) dos pacientes precisou de cirurgia para o tratamento; 31,8% dos que se submeteram à cirurgia precisaram de ressecção intestinal e 13 (3,9%) vieram a óbito. Entre os 21 hospitais que relataram casos durante todo o período de vigilância (2001-2008), a quantidade de casos de intussuscepção em 2007 (n = 26) e 2008 (n = 19) não foi maior do que a quantidade média anual (31, faixa de 24-42) durante os anos-base de 2001-2005. Conclusões: Embora esta análise não tenha identificado um aumento nos casos de intussuscepção nos dois anos após a introdução da RV1, esses resultados justificam a necessidade de métodos epidemiológicos especiais para avaliar a possível associação entre a vacina contra rotavírus e esse evento adverso muito raro.

Abstract Objective: Intussusception surveillance was initiated after the nationwide introduction of live attenuated monovalent rotavirus vaccine (RV1). The objective is to assess the epidemiology of intussusception and compare the number of cases before and after the introduction of rotavirus vaccine. Methods: Cases of intussusception occurring between March 2006 and January 2008 were identified through a prospective enhanced passive surveillance system established in sentinel state hospitals. Retrospective review of medical records was used to identify cases, which occurred in sentinel hospitals between January 2001 and February 2006. Results: From 2001 to 2008, 331 intussusception cases were identified, 59.5% were male, with peak incidence among those 18–24 weeks of age. Overall <10% of cases were among infants 6–14 weeks of age (when the first dose of RV1 is administered). The most frequently observed signs or symptoms of intussusception included vomiting (89.4%), bloody stool (75.5%), and abdominal distention (71.8%). A majority (92.1%) of the case-patients required surgery for treatment; 31.8% of those who underwent surgery required bowel resection, and 13 (3.9%) died. Among the 21 hospitals that reported cases throughout the entire surveillance period (2001–2008), the number of intussusception events during 2007 (n = 26) and 2008 (n = 19) was not greater than the average annual number (n = 31, range 24–42) during baseline years 2001–2005. Conclusions: Although this analysis did not identify an increase in intussusception cases during the two years after RV1 introduction, these results support the need for special epidemiologic methods to assess the potential link between rotavirus vaccine and this very rare adverse event.

Abstract Objective: Transposition of the great arteries is a common congenital heart disease. Arterial switch is the gold standard operation for this complex heart disease. Arterial switch operation in the presence of intramural coronary artery is surgically the most demanding even for the most experienced hands. We are presenting our experience with a modified technique for intramural coronary arteries in arterial switch operation. Methods: This prospective study involves 450 patients undergoing arterial switch operation at our institute from April 2006 to December 2013 (7.6 years). Eighteen patients underwent arterial switch operation with intramural coronary artery. The coronary patterns and technique used are detailed in the text. Results: The overall mortality found in the subgroup of 18 patients having intramural coronary artery was 16% (n=3). Our first patient had an accidental injury to the left coronary artery and died in the operating room. A seven-day old newborn died from intractable ventricular arrhythmia fifteen hours after surgery. Another patient who had multiple ventricular septal defects with type B arch interruption died from residual apical ventricular septal defect and sepsis on the eleventh postoperative day. The remainder of the patients are doing well, showing a median follow-up duration of 1235.34±815.26 days (range 369 - 2730). Conclusion: Transposition of the great arteries with intramural coronary artery is demanding in a subset of patients undergoing arterial switch operation. We believe our technique of coronary button dissection in the presence of intramural coronary arteries using coronary shunt is simple and can be a good addition to the surgeons' armamentarium.

Objective To assess, by socioeconomic setting, the effect of nationwide vaccination against species A rotavirus (RVA) on childhood diarrhoea-related hospitalizations in Mexico. Methods Data on children younger than 5 years who were hospitalized for diarrhoea in health ministry hospitals between 1 January 2003 and 31 December 2011 were collected from monthly discharge reports. Human development indexes were used to categorize the states where hospitals were located as having generally high, intermediate or low socioeconomic status. Annual rates of hospitalization for diarrhoea – per 10 000 hospitalizations for any cause – were calculated. Administrative data were used to estimate vaccine coverage. Findings In the states with high, intermediate and low socioeconomic status, coverage with a two-dose monovalent RVA vaccine – among children younger than 5 years – had reached 93%, 86% and 71%, respectively, by 2010. The corresponding median annual rates of hospitalization for diarrhoea – per 10 000 admissions – fell from 1001, 834 and 1033 in the “prevaccine” period of 2003–2006, to 597, 497 and 705 in the “postvaccine” period from 2008 to 2011, respectively. These decreases correspond to rate reductions of 40% (95% confidence interval, CI: 38–43), 41% (95% CI: 38–43) and 32% (95% CI: 29–34), respectively. Nationwide, RVA vaccination appeared to have averted approximately 16 500 hospitalizations for childhood diarrhoea in each year of the postvaccine period. Conclusion Monovalent RVA vaccination has substantially reduced childhood diarrhoea-related hospitalizations for four continuous years in discretely different socioeconomic populations across Mexico.

Resumen Objetivo Evaluar, por el contexto socioeconómico, el efecto de la vacunación a escala nacional contra el rotavirus de tipo A (RVA) en las hospitalizaciones vinculadas a la diarrea infantil en México. Métodos Se recopilaron datos sobre niños menores de 5 años hospitalizados por diarrea en hospitales del Ministerio de Salud entre el 1 de enero de 2003 y el 31 de diciembre de 2011 a partir de los informes de altas hospitalarias mensuales. Se usaron índices de desarrollo humano para clasificar los estados donde los hospitales estaban situados según un nivel socioeconómico generalmente alto, intermedio o bajo. Se calcularon las tasas anuales de hospitalización por diarrea, por 10 000 hospitalizaciones por cualquier causa. Se emplearon datos administrativos para estimar la cobertura de la vacuna. Resultados En los estados con nivel socioeconómico alto, intermedio y bajo, la cobertura de la vacuna monovalente contra el rotavirus de tipo A de dos dosis había alcanzado entre los niños menores de 5 años el 93 %, 86 % y 71 %, respectivamente, en el año 2010. Las tasas anuales medias correspondientes de hospitalización por diarrea (por 10 000 ingresos) cayeron, respectivamente, de 1001, 834 y 1033 en el periodo «prevacuna» entre 2003 y 2006, a 597, 497 y 705 en el periodo «posvacuna» entre 2008 y 2011. Estas disminuciones se corresponden con reducciones de las tasas del 40 % (intervalo de confianza del 95 %, IC: 38–43), 41 % (IC del 95 %: 38–43) y el 32 % (IC del 95 %: 29–34), respectivamente. A nivel nacional, la vacunación contra el rotavirus de tipo A parece haber evitado unas 16 500 hospitalizaciones por diarrea infantil cada año del periodo «posvacuna». Conclusión La vacunación monovalente contra el RVA ha reducido sustancialmente las hospitalizaciones relacionadas con la diarrea infantil durante cuatro años seguidos en poblaciones socioeconómicas ligeramente distintas de todo México.

Résumé Objectif Évaluer, par contexte socio-économique, les effets de la vaccination nationale contre le rotavirus A (RVA) sur les hospitalisations liées à la diarrhée infantile au Mexique. Méthodes Les données chez les enfants de moins de 5 ans qui ont été hospitalisés pour cause de diarrhée dans les hôpitaux du ministère de la santé entre le 1er janvier 2003 et le 31 décembre 2011 ont été recueillies à partir des rapports mensuels de sortie des hôpitaux. Des indices de développement humain ont été utilisés pour classer les états dans lesquels les hôpitaux sont situés comme des états ayant un statut socio-économique généralement élevé, intermédiaire ou bas. Les taux annuels d'hospitalisation pour cause de diarrhée – par 10 000 hospitalisations, quelle qu'en soit la cause – ont été calculés. Les données administratives ont été utilisées pour estimer la couverture vaccinale. Résultats Dans les états présentant des statuts socio-économiques élevés, intermédiaires et bas, la couverture avec un vaccin monovalent contre le RVA administré en 2 doses – parmi les enfants de moins de 5 ans – a atteint 93%, 86% et 71%, respectivement, en 2010. Les taux annuels médians d'hospitalisation correspondants pour cause de diarrhée – par 10 000 admissions – ont chuté de 1001, 834 et 1033 dans la période «pré-vaccinale» de 2003 à 2006, à 597, 497 et 705 dans la période «post-vaccinale» de 2008 à 2011, respectivement. Ces diminutions correspondent à des réductions de taux de 40% (Intervalle de Confiance (IC) à 95%: 38–43), 41% (IC à 95%: 38–43) et 32% (IC à 95%: 29–34), respectivement. Dans tout le pays, la vaccination contre le RVA semble avoir évité environ 16 500 hospitalisations pour cause de diarrhée infantile chaque année au cours de la période post-vaccinale. Conclusion La vaccination monovalente contre le RVA a substantiellement réduit les hospitalisations liées à la diarrhée infantile pendant quatre ans de suite dans des populations socio-économiques différentes et distinctes dans tout le Mexique.

Countries in Latin America were among the first to implement routine vaccination against species A rotavirus (RVA). We evaluate data from Latin America on reductions in gastroenteritis and RVA disease burden following the introduction of RVA vaccine. Published literature was reviewed to identify case-control studies of vaccine effectiveness and population-based studies examining longitudinal trends of diarrhoeal disease reduction after RVA vaccine introduction in Latin American countries. RVA vaccine effectiveness and impact on gastroenteritis mortality and hospitalization rates and RVA hospitalization rates are described. Among middle-income Latin American countries with published data (Mexico, Brazil, El Salvador and Panama), RVA vaccine contributed to a gastroenteritis-associated mortality reduction of 22-41%, a gastroenteritis-associated hospitalization reduction of 17-51% and a RVA hospitalization reduction of 59-81% among children younger than five years of age. In Brazil and El Salvador, case-control studies demonstrated that a full RVA vaccination schedule was 76-85% effective against RVA hospitalization; a lower effectiveness of 46% was seen in Nicaragua, the only low-income country with available data. A growing body of literature offers convincing evidence of "real world" vaccine program successes in Latin American settings, which may be expanded as more countries in the region include RVA vaccine in their immunization programs.

Um método empregando LC-MS/MS foi desenvolvido para a análise de rosuvastatina em plasma humano, usando atorvastatina como padrão interno. Rosuvastatina é um fármaco para redução de lipídeos e prescrita para o tratamento do hipercolesterolemia e de dislipidimia. A extração em fase sólida (SPE) foi usada para purificação e pré-concentração do analito a partir da matriz do plasma humano. A separação cromatográfica foi conseguida em 6.0 min empregando fase móvel composta de 0.2% de ácido fórmico em água e acetonitrila (40: 60,v/v, na vazão de 1.0 mL min-1 e coluna YMC J'sphere ODS H-80, 150 x 4.6 mm, partículas de 4.0 µm. Na saída da coluna, a fase móvel foi dividida, sendo que 200 µL foram dirigidos para o espectrômetro de massas e 800 µL para o descarte. Pelo Monitoramento de Reação Múltipla (MRM), as transições foram medidas no modo positivo em m/z 482 - 258 para rosuvastatina e m/z 559 - 440 para o padrão interno, respectivamente. Uma validação detalhada do método foi realizada seguindo as recomendações do FDA americano e as curvas analíticas foram lineares no intervalo de 1.00 ng mL-1 a 50.00 ng mL-1 com coeficiente de correlação médio maior que 0.99. A recuperação absoluta foi maior que 50.14% para rosuvastatina e 54.65% para o padrão interno. Rosuvastatina foi estável por 138 dias a -70 ± 5 °C e por 24 horas à temperatura ambiente. Após a extração do plasma, as amostras reconstituídas de rosuvastatina permaneceram estáveis no auto injetor, a 10 °C, por 8 horas. Depois de submetidas a três ciclos de congelamento/descongelamento, não houve mudanças na recuperação do analito. O método é simples, específico, sensível, preciso, exato e apropriado para aplicações em bioequivalência e estudos farmacocinéticos. Foi aplicado com sucesso em um estudo piloto de bioequivalência da rosuvastatina, comprimidos - Zydus, Cadila, India versus comprimidos - Crestor, Astra Zeneca, EUA, em voluntários sadios do sexo masculino.

A LC-MS/MS method has been developed for the estimation of rosuvastatin in human plasma using atorvastatin as internal standard. Rosuvastatin is a lipid-lowering drug prescribed for the treatment of hyper-cholestrolemia and dyslipidimia. Solid phase extraction (SPE) was used for the purification and pre-concentration of analyte from human plasma matrix. The chromatographic separation was achieved within 6.0 min by an isocratic mobile phase containing 0.2% formic acid in water and acetonitrile (40: 60, v/v), flowing through YMC J' Sphere ODS H-80, 150 x 4.6 mm, 4.0 µm analytical column, at a flow rate of 1.0 mL min-1 with split of 200 µL to mass spectrometer and 800 µL to waste. Multiple reaction monitoring (MRM) transitions were measured in the positive mode at m/z 482 and 258 for rosuvastatin and m/z 559 and 440 for internal standard respectively. A detailed validation of the method was performed as per USFDA guidelines and the standard curves were found to be linear in the range 1.0 ng mL-1 to 50.0 ng mL-1 with the mean correlation coefficient more than 0.99. The absolute recovery was more than 50.14% for rosuvastatin and 54.65% for internal standard. In human plasma, rosuvastatin was stable for 138 days at -70 ± 5 °C and for 24 hours at ambient temperature. After extraction from plasma, the reconstituted samples of rosuvastatin were stable in auto sampler at 10 °C for 8 hours. Upon subjecting to three freeze thaw cycles, there was no change in the recovery of the analyte. The method was simple, specific, sensitive, precise, accurate and suitable for bioequivalence and pharmacokinetic studies. It was successfully applied to the pilot bioequivalence study of rosuvastatin 20 mg tablets of M/s Zydus Cadila health care Ltd. India versus 20 mg Crestor tablet of M/s Astra Zeneca, USA; in male human subjects.