BackgroundDiabetes during pregnancy is associated with significant risk of complications to the mother, fetus and newborn. We reviewed the potential impact of early detection and control of diabetes mellitus during pregnancy on stillbirths for possible inclusion in the Lives Saved Tool (LiST).MethodsA systematic literature search up to July 2010 was done to identify all published randomized controlled trials and observational studies. A standardized data abstraction sheet was employed and data were abstracted by two independent authors. Meta-analyses were performed with different sub-group analyses. The analyses were graded according to the CHERG rules using the adapted GRADE criteria and recommendations made after assessing the overall quality of the studies included in the meta-analyses.ResultsA total of 70 studies were selected for data extraction including fourteen intervention studies and fifty six observational studies. No randomized controlled trials were identified evaluating early detection of diabetes mellitus in pregnancy versus standard screening (glucose challenge test between 24th to 28th week of gestation) in pregnancy. Intensive management of gestational diabetes (including specialized dietary advice, increased monitoring and tailored dietary therapy) during pregnancy (3 studies: 3791 participants) versus conventional management (dietary advice and insulin as required) was associated with a non-significant reduction in the risk of stillbirths (RR 0.20; 95% CI: 0.03-1.10) (‘moderate’ quality evidence). Optimal control of serum blood glucose versus sub-optimal control was associated with a significant reduction in the risk of perinatal mortality (2 studies, 5286 participants: RR=0.40, 95% CI 0.25- 0.63), but not stillbirths (3 studies, 2469 participants: RR=0.51, 95% CI 0.14-1.88). Preconception care of diabetes (information about need for optimization of glycemic control before pregnancy, assessment of diabetes complications, review of dietary habits, intensification of capillary blood glucose self-monitoring and optimization of insulin therapy) versus none (3 studies: 910 participants) was associated with a reduction in perinatal mortality (RR=0.29, 95% CI 0.14 -0.60). Using the Delphi process for estimating effect size of optimal diabetes recognition and management yielded a median effect size of 10% reduction in stillbirths.ConclusionsDiabetes, especially pre-gestational diabetes with its attendant vascular complications, is a significant risk factor for stillbirth and perinatal death. Our review highlights the fact that very few studies of adequate quality are available that can provide estimates of the effect of screening for aid management of diabetes in pregnancy on stillbirth risk. Using the Delphi process we recommend a conservative 10% reduction in the risk of stillbirths, as a point estimate for inclusion in the LiST.

Foregut duplication is commonly found in the posterior mediastinum. 10-20% of these anomalies are associated with oesophageal duplication. It can occur in all parts of oesophageal length. Although duplication of cervical oesophagus has been previously reported, but a majority of them were found in thoracic oesophagus. Infants with oesophageal duplication usually manifested by respiratory distress or asymptomatic thoracic mass, casually, detected in X-ray. A 7-month-old infant weighing about 7.5 kg, with the signboard of respiratory distress, fever and nutritional intolerance was admitted to our hospital. Physical examination showed dehydration, stridor, tachypnoea, intercostal retraction and neck stiffness. Plain chest radiogram showed dubious cystic mass in the distal neck. Cervical and chest computed tomography scan showed neck cystic lesion disseminated to posterior mediastinum, probably propagated to the respiratory system. Cystic lesion connected to oesophagus was partially resected, oesophagus was repaired and remaining mucous of a cyst was removed, then gastrostomy tube was applied. Although cervical oesophageal duplication cysts are rare, but they must be considered as one of the differential diagnoses of cervical mass with respiratory distress in infants.

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Objectives To assess the commonly reported complications and failure modes for FilterWire EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Background EPDs prevent distal embolization of atheroembolic materials during percutaneous interventions resulting in reduced microvascular obstruction and improved microcirculation while maintaining tissue perfusion. The FilterWire EZ EPD (Boston Scientific, Natick, MA) is approved for use in interventions of de novo saphenous vein grafts (SVG) and carotid artery stenosis. Robust data on the commonly reported complications and failure modes associated with the FilterWire EZ device are limited. Methods The MAUDE database was queried from September 1, 2008, through September 30, 2018, for FilterWire EZ system, yielding 474 reports. After exclusion of duplicate and incomplete reports, 464 device reports were included in the final analysis. Results Device‐related adverse events were most commonly reported for carotid (n = 281) and SVG (n = 101) interventions. The most commonly reported major complications were: ischemic stroke (n = 57), vessel perforation or dissection (n = 12), death (n = 8), and myocardial infarction (n = 5). Minor complications included: hypotension (n = 68), bradycardia (n = 41), and vasospasm (n = 27). The most commonly reported failure modes were: detachment and/or damage of the device components (n = 118), device entrapment (n = 90), and stent‐related issues (n = 46). Conclusions Analysis of the MAUDE dataset is helpful in identifying the commonly reported adverse events and failure modes of FilterWire EZ devices. This platform serves as an important tool for both physicians and manufacturers to optimize device performance and clinical outcomes.