Citations

AbstractBackgroundEmpirical evidence regarding the development of sensory responsivity in young children at high likelihood to develop autism spectrum disorder (ASD) remains relatively limited. It is unclear how sensory responsivity behaviors may change over time and impact later developmental outcomes. The goals of this study were to (a) characterize developmental trajectories of sensory responsivity across infancy (∼12 months), toddlerhood (∼24 months), and school age (6–11 years) in children at high and low familial likelihood for ASD; and (b) determine if sensory responsivity in infancy predicts adaptive and cognitive functioning at school age among children with ASD.MethodsGeneralized linear mixed effects models were used to examine scores from the Sensory Experiences Questionnaire in three groups of children including high‐likelihood children later diagnosed with ASD (HL‐ASD; n = 30), high‐likelihood children without ASD (HL‐Neg; n = 150), and low‐likelihood control children not meeting ASD diagnostic criteria (LL‐Neg; n = 94). Hierarchical linear regression was then used to examine the association between sensory responsivity scores in infancy and functional adaptive and cognitive outcomes at school age for children at high likelihood of ASD.ResultsDevelopment of sensory responsivity from infancy to later childhood is best estimated by the effects of chronological age and Group for Sensory Seeking and Hypo responsivity and the additional effect of the interaction of Group and chronological age for Total and Hyper responsivity. Early elevated Hypo responsivity and Sensory Seeking scores are negatively associated with later adaptive behavior but not cognitive level.ConclusionOverall, higher degrees of Sensory Seeking and Hypo sensory responsivity are detectable in autistic children's behavioral repertoires by 12 months of age and associate with reduced adaptive functioning in middle childhood. These results point to the potential importance of early detection and treatment implications of early sensory behaviors.

Abstract Introduction The pivotal study of the extravascular implantable cardioverter‐defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient‐reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. Methods The EV ICD Pivotal Study was a prospective, single‐arm, nonrandomized, global, premarket approval trial. Patients completed the 12‐Item Short Form Survey (SF‐12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. Results From baseline to 6 months, patients within the EV ICD Pivotal Study ( n = 247) reported statistically significant SF‐12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV‐ICD or S‐ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S‐ICD and 73.0 ± 17.4, p = .004 for TV‐ICD). Conclusion The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6‐month follow‐up and markedly better overall acceptance of their ICD compared to a previous study with S‐ICD and TV‐ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Abstract Aims To determine the extent of shared decision-making (SDM), during selection of oral anticoagulant (OAC) and rhythm control treatments, in patients with newly diagnosed atrial fibrillation (AF). Methods and results We evaluated survey data from 1006 patients with new-onset AF enrolled at 56 US sites participating in the SATELLITE substudy of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT II). Patients completed surveys at enrolment and at 6-month follow-up. Patients were asked about who made their AF treatment decisions. Shared decision-making was classified as one that the patient felt was an autonomous decision or a shared decision with their healthcare provider (HCP). Approximately half of patients reported that their OAC treatment decisions were made entirely by their HCP. Compared with those reporting no SDM, patients reporting SDM for OAC were more often female (47.2% vs. 38.4%), while patients reporting SDM for rhythm control were more often male (62.2% vs. 57.6%). The most important factors cited by patients during decision-making for OAC were reducing stroke and bleeding risk, and their HCP’s recommendations. After adjustment, patients with self-reported understanding of OAC, and rhythm control options, had higher odds of having participated in SDM [odds ratio (OR) 2.54, confidence interval (CI): 1.75–3.68 and OR 2.36, CI: 1.50–3.71, both P ≤ 0.001, respectively]. Conclusion Shared decision-making is not widely implemented in contemporary AF practice. Patient understanding about available therapeutic options is associated with a more than a two-fold higher likelihood of SDM, and may be a potential target for future interventions.

Abstract Background Obstructive sleep apnea (OSA) is common in patients with atrial fibrillation (AF). It is not well understood if OSA impacts cardiovascular outcomes in patients with AF. Purpose To investigate patient characteristics and major adverse cardiovascular and neurological events (MACNE) in patients with AF and OSA. Methods Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF I) and ORBIT-AF II we compared the adjusted risk of the composite of cardiovascular death, myocardial infarction, stroke/transient ischemic attack/non-CNS embolism (stroke/SE), and new-onset heart failure (MACNE) according to the presence or absence of OSA, using multivariable adjusted Cox proportional hazard models. Secondary outcomes were the individual components of MACNE. Results Among 22,760 patients with AF, there were 4,045 (17.8%) with OSA at baseline. Median follow-up time was 1.5 (IQR: 1–2.2) years. OSA patients were younger (median [IQR] 68 [61–75] years vs. 74 [66–81] years, were more likely to be male (70.7% vs. 55.3%), and had markedly increased body mass index (BMI) (median 34.6 kg/m2 [29.8–40.2] vs. 28.7 kg/m2 [25.2–33.0]). Those with OSA had a higher prevalence of diabetes (39.2% vs. 25.2%), chronic obstructive pulmonary disease (COPD) (20% vs. 12%), heart failure (32.2% vs. 25.1%), and hyperlipidemia (73.2% vs. 66.7%). After adjustment, the presence of OSA was significantly associated with MACNE (HR: 1.16 [95% CI: 1.03–1.31], p=0.011) [Figure]. Stroke/SE was higher in patients with OSA (HR: 1.38 [95% CI 1.12–1.70], p=0.003). Addition of OSA to a model containing the CHA2DS2-VASc risk factors slightly improved discrimination for stroke/SE: CHA2DS2-VASc risk factors alone C-index (Standard Error) was 0.6867 (0.0125) vs. CHA2DS2-VASc risk factors plus OSA 0.6876 (0.0124), p=0.022. Figure 1. Hazard ratios with 95% confidence intervals and event rates for the association between obstructive sleep apnea and major adverse cardiovascular and neurological events combined and separately. Abbreviations: OSA; obstructive sleep apnea MACNE; major adverse cardiovascular and neurological events, CV; cardiovascular, TIA; transient ischemic attack. Conclusion One in five patients with AF in community practice had OSA. The presence of OSA was associated with higher risk of MACNE and stroke/SE. Addition of OSA to CHA2DS2-VASc risk factors only slightly improved discrimination for the occurrence of stroke. Acknowledgement/Funding The Danish Heart Foundation, T32 NIH Grant HL079896. The ORBIT-AF registry is sponsored by Janssen.

Abstract New gene-editing tools challenge conventional policy proscriptions of research aimed at either human germline gene editing or human enhancement by potentially lowering technical barriers to both kinds of intervention. Some recent gene-editing reports have begun to take up the prospect of germline editing, but most experts are in broad agreement that research should prioritize medical applications over attempts to enhance human traits. However, there is little consensus about what counts as human enhancement in this context, or how to deal with the issues it flags. Moreover, several influential reports interpret medical applications to include disease prevention as well as treatment as a goal for gene-editing research. This challenges the current policy consensus because using gene editing to prevent disease would incidentally facilitate human enhancement applications in a variety of ways. If such research efforts are penalized by policy concerns about enhancement, then their preventive health benefits could be lost. To avoid being caught off guard by such challenges, science policy makers will need to think more carefully about what “prevention” might mean in the gene-editing context, and develop research governance that can anticipate and address the human enhancement concerns it will raise. To accomplish the latter, the scope of policy making will need to expand from its narrow focus on human clinical trials to engage with basic researchers driving the translational pipeline toward preventive gene editing and the science policy makers who have to address its “off-label” uses.