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Implantable cardioverter defibrillators (ICDs) improve survival in patients at risk for cardiac arrest, but are associated with intravascular lead-related complications. The subcutaneous ICD (S-ICD), with no intravascular components, was developed to minimize lead-related complications.To assess key ICD performance measures related to delivery of ICD therapy, including inappropriate ICD shocks (delivered in absence of life-threatening arrhythmia) and failed ICD shocks (which did not terminate ventricular arrhythmia).Randomized, multicenter trial. (ClinicalTrials.gov: NCT02881255).The ATLAS trial.544 eligible patients (141 female) with a primary or secondary prevention indication for an ICD who were younger than age 60 years, had a cardiogenetic phenotype, or had prespecified risk factors for lead complications were electrocardiographically screened and 503 randomly assigned to S-ICD (251 patients) or transvenous ICD (TV-ICD) (252 patients). Mean follow-up was 2.5 years (SD, 1.1). Mean age was 49.0 years (SD, 11.5).The primary outcome was perioperative major lead-related complications.There was a statistically significant reduction in perioperative, lead-related complications, which occurred in 1 patient (0.4%) with an S-ICD and in 12 patients (4.8%) with TV-ICD (-4.4%; 95% CI, -6.9 to -1.9;At present, the ATLAS trial is underpowered to detect differences in clinical shock outcomes; however, extended follow-up is ongoing.The S-ICD reduces perioperative, lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain and a trend for more inappropriate shocks.Boston Scientific.

Background: The greatest mortality and disability from stroke occurs in low- and middle-income countries. A significant barrier to implementation of best stroke care practices in these settings is limited availability of specialized healthcare training. We conducted a systematic review to determine the most effective methods for the provision of speciality stroke care education for hospital-based healthcare professionals in low-resource settings. Methods: We followed the PRISMA guidelines for systematic reviews and searched PubMed, Web of Science and Scopus for original clinical research articles that described or evaluated stroke care education for hospital-based healthcare professionals in low-resource settings. Two reviewers screened titles/abstracts and then full text articles. Three reviewers critically appraised the articles selected for inclusion. Results: A total of 1,182 articles were identified and eight were eligible for inclusion in this review; three were randomized controlled trials, four were non-randomized studies, and one was a descriptive study. Most studies used several approaches to education. A “train-the-trainer” approach to education was found to have the most positive clinical outcomes (lower overall complications, lengths of stay in hospital, and clinical vascular events). When used for quality improvement, the “train-the-trainer” approach increased patient reception of eligible performance measures. When technology was used to provide stroke education there was an increased frequency in diagnosis of stroke and use of antithrombotic treatment, reduced door-to-needle times, and increased support for decision making in medication prescription was reported. Task-sharing workshops for non-neurologists improved knowledge of stroke and patient care. Multidimensional education demonstrated an overall care quality improvement and increased prescriptions for evidence-based therapies although there were no significant differences in secondary prevention efforts, stroke reoccurrence, or mortality rates. Discussion: The “train the trainer” approach is likely the most effective strategy for specialist stroke education, while technology is also useful if resources are available to support its development and use. If resources are limited, basic knowledge education should be considered at a minimum, and multidimensional training may not be as beneficial. Communities of practice, led by those in similar settings, may be helpful to develop educational initiatives with relevance to local contexts.

Background Premature infants may demonstrate feeding difficulties requiring an instrumental swallowing assessment. Fiberoptic endoscopic evaluation of swallowing (FEES) is one assessment that can evaluate bottle feeding and breastfeeding. Purpose This pilot study investigated the safety and feasibility of FEES for neonatal intensive care unit (NICU) infants during breastfeeding. Methods The setting for this prospective, descriptive study was an urban level III NICU that provided care for premature and critically ill infants. Participants were 5 infants recruited from a convenience sample who were at least 37 weeks postmenstrual age, demonstrated feeding difficulties during a bedside feeding and swallowing examination, and were breastfeeding. Each participant received a FEES assessment while breastfeeding (FEES-B). Adverse events and vital signs including prefeeding and postfeeding respiratory rate, heart rate, and oxygen saturation level were recorded to assess safety. Visualization of milk, laryngeal penetration, and tracheal aspiration assessed feasibility. Results Participants had a mean postmenstrual age of 39.8 weeks. No adverse events, including epistaxis or laryngospasm, were reported; there were no instances of autonomic instability; and there were no statistically significant differences between prefeeding and postfeeding respiratory rate, heart rate, or oxygen saturation level. Two infants successfully breastfed during FEES-B. Human milk was observable, and laryngeal penetration was noted with 1 infant. Implication for practice FEES-B was found to be safe, with limited data supporting feasibility. Infants demonstrated no physiologic instability during FEES-B, and milk was visualized in the pharynx during breastfeeding with 2 infants. Implication for research Further studies are warranted to assess effectiveness of FEES-B in infants.

To determine the diagnostic accuracy of videofluoroscopy (VFSS) and endoscopy (FEES) in detecting laryngeal penetration and tracheal aspiration in bottle-fed young infants in the NICU. VFSS and FEES findings of 22 infants were compared to each other and to a composite reference standard in this prospective study. Sensitivity, specificity, positive and negative predictive values were calculated for each assessment. Agreement between VFSS and FEES was high (92%) for aspiration and moderate (56%) for penetration, with FEES detecting more instances of penetration. Compared to the composite reference standard, FEES had greater sensitivity and a higher negative predictive value for penetration than VFSS. Because of the low prevalence of aspiration, diagnostic accuracy could not be determined for aspiration for either assessment. FEES appears to be more accurate in detecting penetration in this population, and both assessments are valuable tools in a comprehensive feeding and swallowing evaluation.

Background The BRUISE CONTROL trial (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial) demonstrated that a strategy of continued warfarin during cardiac implantable electronic device surgery was safe and reduced the incidence of clinically significant pocket hematoma (CSH). CSH was defined as a post-procedure hematoma requiring further surgery and/or resulting in prolongation of hospitalization of at least 24 h, and/or requiring interruption of anticoagulation. Previous studies have inconsistently associated hematoma with the subsequent development of device infection; reasons include the retrospective nature of many studies, lack of endpoint adjudication, and differing subjective definitions of hematoma. Objectives The BRUISE CONTROL INFECTION (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial Extended Follow-Up for Infection) prospectively examined the association between CSH and subsequent device infection. Methods The study included 659 patients with a primary outcome of device-related infection requiring hospitalization, defined as 1 or more of the following: pocket infection; endocarditis; and bloodstream infection. Outcomes were verified by a blinded adjudication committee. Multivariable analysis was performed to identify predictors of infection. Results The overall 1-year device-related infection rate was 2.4% (16 of 659). Infection occurred in 11% of patients (7 of 66) with previous CSH and in 1.5% (9 of 593) without CSH. CSH was the only independent predictor and was associated with a >7-fold increased risk of infection (hazard ratio: 7.7; 95% confidence interval: 2.9 to 20.5; p Conclusions CSH is associated with a significantly increased risk of infection requiring hospitalization within 1 year following cardiac implantable electronic device surgery. Strategies aimed at reducing hematomas may decrease the long-term risk of infection. (Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL]; NCT00800137 )

To evaluate the safety of fiberoptic endoscopic evaluation of swallowing (FEES) and the reliability of both FEES and a videofluoroscopic swallowing study (VFSS) in identifying laryngeal penetration and tracheal aspiration in infants under 3 months old in the neonatal intensive care unit (NICU). Twenty-five infants at least 37 weeks postmenstrual age suspected of aspirating were assessed with FEES and VFSS. Complications, autonomic instability and vital signs before endoscope insertion and following FEES were documented. Blinded video recordings were coded by two reviewers to determine reliability. We found no major complications or significant differences between FEES prefeeding and postfeeding vital signs, including respiratory rate, heart rate or oxygen saturation. FEES interrater reliability was 80% for both penetration and aspiration, compared with 87 and 90%, respectively, for VFSS. FEES is safe and reliable in assessing laryngeal penetration and tracheal aspiration in NICU infants.

The standard procedure to assess an infant in the neonatal intensive care unit (NICU) who is suspected of aspirating on oral feedings is a videofluoroscopic swallowing study (VFSS). The VFSS has been used for more than 30 years to assess dysphagia and is considered the gold standard. However, there are challenges to the VFSS, including radiation exposure, transport to radiology, usage of barium, limited positioning options, and cost. An alternative approach is fiberoptic endoscopic evaluation of swallowing (FEES), which uses a flexible endoscope passed transnasally into the pharynx to assess anatomy, movement/sensation of structures, swallow function, and response to therapeutic interventions. Fiberoptic endoscopic evaluation of swallowing has been established as a valid tool for evaluating dysphagia and utilized as an alternative or supplement to the VFSS in both adults and children.This article provides an overview of the current challenges in the NICU with assessing aspiration and introduces a multidisciplinary FEES program for bottle and breastfeeding.A review of the literature of dysphagia, VFSS, and FEES in the adult, pediatric, infant, and neonatal populations was performed. Clinical competency standards were researched and then implemented through an internal process of validation. Finally, a best practice protocol was designed as it relates to FEES in the NICU.Fiberoptic endoscopic evaluation of swallowing is a safe alternative to the VFSS. It can be utilized at the infant's bedside in a NICU for the diagnosis and treatment of swallowing disorders by allowing the clinician the ability to replicate a more accurate feeding experience, therefore, determining a safe feeding plan.Competency and training are essential to establishing a multidisciplinary FEES program in the NICU.Further research is needed to compare the efficacy and validity of FEES versus VFSS for infants in the NICU. Furthermore, evaluating the efficacy of FEES during breastfeeding is warranted.

Introduction: Patient decision aids (PtDA) support quality decision making and improve patient reported outcomes. This pilot randomized controlled trial aimed to evaluate the use of an ICD specific PtDA on patient’s decisional conflict and ICD knowledge. Methods: In accordance with the International Patient Decision Aid Standards (IPDAS), a PtDA was developed. We conducted a single-centre non-blinded RCT with concealed allocation to evaluate the effect of a PtDA in patients offered an ICD for primary prevention. Exclusions: 1) inability to read English and complete a PtDA, 2) ICD for secondary prevention, 3) biventricular devices. Consented patients were randomized to 1) usual care, 2) PtDA intervention. Prior to specialist consultation the PtDA intervention group received the PtDA. The primary outcome of decisional conflict was measured before consultation and post-ICD implantation. The decisional conflict scale measures patient’s perception of difficultly making a decision, uncertainty regarding the decision and factors contributing to uncertainty. Higher scores are indicative of greater decisional conflict. Knowledge was measured as a secondary outcome using 5 questions related to ICD treatment, benefits and risks. Results: Eighty-two patients were randomized to usual care (n=41) or PtDA intervention (n=41). Mean age (SD) was 66.76 (11.05), 27% female. Baseline characteristics between groups were balanced. Patients receiving the PtDA intervention scored significantly lower on the DCS scale with a total mean score of 27.32 (18.37) when compared to usual care, scoring 49.53 (18.62) (p Conclusion: The results of this pilot study suggest that use of an ICD-specific PtDA reduced patient’s decisional conflict both pre and post implantation and improved knowledge. In the context of making decisions regarding life prolonging interventions, our findings suggest evidence based decision support results in improved patient decision quality.