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Aims: We aimed to estimate the rate of renal artery adverse events following renal denervation with the most commonly applied radiofrequency catheter system based on a comprehensive review of published reports. Methods and results: We reviewed 50 published renal denervation (RDN) trials reporting on procedural safety including 5,769 subjects with 10,249 patient-years of follow-up. Twenty-six patients with renal artery stenosis or dissection (0.45%) were identified of whom 24 (0.41%) required renal artery stenting. The primary meta-analysis of all reports indicated a 0.20% pooled annual incidence rate of stent implantation (95% CI: 0.12 to 0.29% per year). Additional sensitivity analyses yielded consistent pooled estimates (range: 0.17 to 0.42% per year). Median time from RDN procedure to all renal intervention was 5.5 months (range: 0 to 33 months); 79% of all events occurred within one year of the procedure. A separate review of 14 clinical trials reporting on prospective follow-up imaging using either magnetic resonance imaging, computed tomography or angiography following RDN in 511 total subjects identified just 1 new significant stenosis (0.20%) after a median of 11 months post procedure (one to 36 months). Conclusions: Renal artery reintervention following renal denervation with the most commonly applied RF renal denervation system (Symplicity) is rare. Most events were identified within one year.

BACKGROUND: Some 20 y ago, scientific and regulatory communities identified the potential of omics sciences (genomics, transcriptomics, proteomics, metabolomics) to improve chemical risk assessment through development of toxicogenomics. Recognizing that regulators adopt new scientific methods cautiously given accountability to diverse stakeholders, the scope and pace of adoption of toxicogenomics tools and data have nonetheless not met the ambitious, early expectations of omics proponents. OBJECTIVE: Our objective was, therefore, to inventory, investigate, and derive insights into drivers of and obstacles to adoption of toxicogenomics in chemical risk assessment. By invoking established social science frameworks conceptualizing innovation adoption, we also aimed to develop recommendations for proponents of toxicogenomics and other new approach methodologies (NAMs). METHODS: We report findings from an analysis of 56 scientific and regulatory publications from 1998 through 2017 that address the adoption of toxicogenomics for chemical risk assessment. From this purposeful sample of toxicogenomics discourse, we identified major categories of drivers of and obstacles to adoption of toxicogenomics tools and data sets. We then mapped these categories onto social science frameworks for conceptualizing innovation adoption to generate actionable insights for proponents of toxicogenomics. DISCUSSION: We identify the most salient drivers and obstacles. From 1998 through 2017, adoption of toxicogenomics was understood to be helped by drivers such as those we labeled Superior scientific understanding, New applications, and Reduced cost & increased efficiency but hindered by obstacles such as those we labeled Insufficient validation, Complexity of interpretation, and Lack of standardization. Leveraging social science frameworks, we find that arguments for adoption that draw on the most salient drivers, which emphasize superior and novel functionality of omics as rationales, overlo

Chemical contamination of natural ecosystems is regarded as one of our planet's greatest threats (Landrigan et al. 2018). Contaminant‐related phenomena such as malformed frogs, fish with tumors, and dwindling bird populations increasingly fuel societal concerns. Legislation in North America and Europe mandates the assessment and reduction of risk for thousands of commercially important chemical substances used by society and released into the environment. For example, large‐scale efforts such as the Chemicals Management Plan in Canada, the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) program, and the US Environmental Protection Agency's (USEPA's) ToxCast program under the Toxic Substances Control Act (1976) were implemented to address legislative obligations to identify, prioritize, and take action on chemicals found to be harmful. However, these regulatory programs face significant challenges. The number of chemical substances for which toxicity data are required is tremendous and backlogged (e.g., 23 000 initially in Canada; 85 000 in the United States; upward of 101 000 in the European Union) and continues to grow by approximately 500 to 1000 new substances each year. In addition, regulations such as Canada's Wastewater Systems Effluent Regulations (section 36, Fisheries Act), the US National Pollutant Discharge Elimination System, and the European Union's Water Framework Directive (2000/60/EC) mandate the monitoring of municipal and industrial effluents with regard to their potential impacts on aquatic ecosystem health. These programs require the testing of complex environmental samples (e.g., water, effluents, and sediments) for compliance; however, treatment and remediation efforts represent huge, unresolved challenges for chemicals management stakeholders, including those in regulatory agencies and industry.

Background: This study explores mothers’ wellbeing, experiences and attitudes and the impact of cumulative demographic and antenatal risks and parity on parenting outcomes. A secondary aim was to assess mother and infant service utilisation. Method: This study involved an assessment of the baseline characteristics of a sample of mothers (N=190; Mean age = 31.6 years, SD = 5.4) with young infants (average age = 10.13 weeks, SD = 0.8) living in disadvantaged communities in Ireland. Results: Mothers with more risk factors (e.g. lone and/or teenage parenthood, socioeconomic disadvantage and low social support) reported significantly higher levels of depression and lower parental self‐efficacy. Observations of the home environment indicated that at‐risk parents engaged in less cognitive stimulation and lower levels of emotional support for their child. The impact of these risk factors differed for primiparous and multiparous mothers. Conclusions: At‐risk mothers are more susceptible to mental health difficulties and poorer parenting outcomes during the transition to parenthood. This study also provides important comparative insights into experiences of primiparous and multiparous parents. These findings have important implications for practitioners and policy makers, particularly the provision of universal and proportionate supports to prevent and/or interrupt poor parent‐child relationships and negative developmental outcomes.