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Background: Atrial fibrillation (AF) increases the risk of death, stroke, heart failure, cognitive decline, and healthcare costs but is often asymptomatic and undiagnosed. There is currently no national screening program for AF. The advent of validated hand-held devices allows AF to be detected in non-healthcare settings, enabling screening to be undertaken within the community., Method and Results: In this novel observational study, we embedded a MyDiagnostick single lead ECG sensor into the handles of shopping trolleys in four supermarkets in the Northwest of England: 2155 participants were recruited. Of these, 231 participants either activated the sensor or had an irregular pulse, suggesting AF. Some participants agreed to use the sensor but refused to provide their contact details, or consent to pulse assessment. In addition, some data were missing, resulting in 203 participants being included in the final analyses. Fifty-nine participants (mean age 73.6 years, 43% female) were confirmed or suspected of having AF; 20 were known to have AF and 39 were previously undiagnosed. There was no evidence of AF in 115 participants and the remaining 46 recordings were non-diagnostic, mainly due to artefact. Men and older participants were significantly more likely to have newly diagnosed AF. Due to the number of non-diagnostic ECGs (n = 46), we completed three levels of analyses, excluding all non-diagnostic ECGs, assuming all non-diagnostic ECGs were masking AF, and assuming all non-diagnostic ECGs were not AF. Based on the results of the three analyses, the sensor's sensitivity (95% CI) ranged from 0.70 to 0.93; specificity from 0.15 to 0.97; positive predictive values (PPV) and negative predictive values (NPV) ranged from 0.24 to 0.56 and 0.55 to 1.00, respectively. These values should be interpreted with caution, as the ideal reference standard on 1934 participants was imperfect., Conclusion: The study demonstrates that the public will engage with AF screening undertaken as part of their daily routines using hand-held devices. Sensors can play a key role in identifying asymptomatic patients in this way, but the technology must be further developed to reduce the quantity of non-diagnostic ECGs., Competing Interests: Disclosures The study is independently led by the academic team and is supported by educational grant funding from Bristol Myers Squibb. Deirdre Lane received investigator-initiated educational grants from Bristol-Myers Squibb (BMS) and Pfizer, has been a speaker for Bayer, Boehringer Ingelheim, and BMS/Pfizer and has consulted for BMS and Boehringer Ingelheim; all outside the submitted work. Peter Penson owns four shares in AstraZeneca PLC and has received honoraria and/or travel reimbursement for events sponsored by AKCEA, Amgen, AMRYT, Link Medical, Mylan, Napp, Sanofi. Lis Neubeck has received an investigator-initiated grant from Daiichi Sankyo, payment from Bristol Myers Squib for participation in a Global Medical Advisory Board and is the Former President of the Association for Cardiovascular Nursing and Allied Professionals of the ESC. Gregory Lip has been Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, Anthos. No fees are received personally. He is co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No 899871. No further conflicts of interest declared., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Despite improvements in medical care, the quality of life of adults and adolescents with congenital heart disease remains strongly affected by their condition, often leading to depression. Psychotherapy, cognitive behavioural therapy, and other talking therapies may be effective in treating depression in both adults and young adults with congenital heart disease. The aim of this review was to assess the effects of treatments, such as psychotherapy, cognitive behavioural therapies, and talking therapies for treating depression in this population., Objectives: To evaluate the effects (both harms and benefits) of psychological interventions for reducing symptoms of depression in adolescents (aged 10 to 17 years) and adults with congenital heart disease. Psychological interventions include cognitive behavioural therapy, psychotherapy, or 'talking/counselling' therapy for depression., Search Methods: We updated searches from the 2013 Cochrane Review by searching CENTRAL, four other databases, and Conference Proceedings Citation Index to 7 March 2023, and two clinical trial registers to February 2021. We applied no language restrictions., Selection Criteria: Randomised controlled trials (RCTs) comparing psychological interventions to no intervention in the congenital heart disease population, aged 10 years and older, with depression., Data Collection and Analysis: Two review authors independently screened titles and abstracts, and independently assessed full-text reports for inclusion. Further information was sought from the authors if needed. Data were extracted in duplicate. We used standard Cochrane methods. Our primary outcome was a change in depression. Our secondary outcomes were: acceptability of treatment, quality of life, hospital re-admission, non-fatal cardiovascular events, cardiovascular behavioural risk factor, health economics, cardiovascular mortality, all-cause mortality. We used GRADE to assess the certainty of evidence for our primary outcome only., Main Results: We identified three new RCTs (480 participants). Participants were adults with congenital heart disease. Included studies varied in intervention length (90 minutes to 3 months) and follow-up (3 to 12 months), with depression assessed post-intervention and at follow-up. Risk of bias assessment identified an overall low risk of bias for the main outcome of depression. Psychological interventions (talking/counselling therapy) may reduce depression more than usual care at both three-month (mean difference (MD) -1.07, 95% confidence interval (CI) -1.84 to -0.30; P = 0.006; I 2 = 0%; 2 RCTs, 156 participants; low-certainty evidence), and 12-month follow-up (MD -1.02, 95% CI -1.92 to -0.13; P = 0.02; I 2 = 0%; 2 RCTs, 287 participants; low-certainty evidence). There was insufficient evidence to draw conclusions about the impact of psychological interventions on quality of life. None of the included studies reported on our other outcomes of interest. Due to the low number of studies included, we did not undertake any subgroup analyses. One study awaits classification., Authors' Conclusions: Psychological interventions may reduce depression in adults with congenital heart disease compared to usual care. However, the certainty of the evidence is low. Further research is needed to establish the role of psychological interventions in this population, defining the optimal duration, method of administration, and number of sessions required to obtain the greatest benefit., (Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: The present study focuses on assessing the physical activity level of children with Fontan circulation for Hypoplastic Left Heart Syndrome and identifying potential barriers and facilitators toward their participation in physical activity., Patients and Methods: Seven children aged 5-16 years (mean (SD) 8.8 (3.7) years) with a Fontan procedure for hypoplastic left heart syndrome, their parents (n = 7), and siblings (n = 1) were recruited. Data were collected using a mixed-methods approach: (i) children wore an activity monitor for 7 days to record physical activity, with sedentary time and level of activity calculated from accelerometer data; (ii) children completed a bespoke questionnaire recording limitations in physical activity; (iii) parents completed a semi-structured interview discussing perceptions about their child's physical activity participation. Qualitative data were analysed using thematic analysis., Results: Activity monitors data recorded highly active children with a mean (SD) of 153(36) minutes/day spent in moderate-to-vigorous physical activity. Time spent in sedentary behaviour was also high (57.5% of total accelerometer wearing-time). Four key themes relating to parental perceptions of physical activity were identified: (i) A new lease of life -post-Fontan; (ii) Setting limits - managing limitations; (iii) The wider world - how others set limits; and (iv) "I fear the future" - parental concerns., Conclusion: Following completion of the Fontan circulation, children engaged in higher levels of physical activity in comparison to the national average. However, more than half their time was spent in sedentary behaviour. Fears and anxiety from parents and teachers may act as a barrier toward physical activity participation.

Prenatal diagnosis of congenital disease improves clinical outcomes; however, as many as 50% of congenital heart disease cases are missed by current ultrasound screening methods. This indicates a need for improved screening technology. Extracellular vesicles (EVs) have attracted enormous interest in recent years for their potential in diagnostics. EVs mediate endocrine signalling in health and disease and are known to regulate aspects of embryonic development. Here, we critically evaluate recent evidence suggesting that EVs released from the foetus are able to cross the placenta and enter the maternal circulation. Furthermore, EVs from the mother appear to be transported in the reverse direction, whilst the placenta itself acts as a source of EVs. Experimental work utilising rodent models employing either transgenically encoded reporters or application of fluorescent tracking dyes provide convincing evidence of foetal-maternal crosstalk. This is supported by clinical data demonstrating expression of placental-origin EVs in maternal blood, as well as limited evidence for the presence of foetal-origin EVs. Together, this work raises the possibility that foetal EVs present in maternal blood could be used for the diagnosis of congenital disease. We discuss the challenges faced by researchers in translating these basic science findings into a clinical non-invasive prenatal test., (© 2022. The Author(s).)

Background: For patients with atrial fibrillation who survive an intracranial hemorrhage (ICrH), the decision to offer oral anticoagulation (OAC) is challenging and necessitates balancing risk of thromboembolic events with risk of recurrent ICrH., Methods: This systematic review assesses the effectiveness and safety of OAC and/or antiplatelets in patients with atrial fibrillation with nontraumatic ICrH. Bibliographic databases CENTRAL, MEDLINE, EMBASE, and CINAHL were searched. Articles on adults with atrial fibrillation with spontaneous ICrH (intracerebral, subdural, and subarachnoid), receiving antithrombotic therapy for stroke prevention were eligible for inclusion., Results: Twenty articles (50 470 participants) included 2 randomized controlled trials (n=304)' 8 observational studies, 8 cohort studies, and 2 studies that meta-analyzed individual-level data from observational studies. OAC therapy was associated with a significant reduction in thromboembolic events (summary relative risk [sRR], 0.51 [95% CI, 0.30-0.86], heterogeneity I 2 =2%; P =0.39, n=5 studies) and all-cause mortality (sRR, 0.52 [95% CI, 0.38-0.71], heterogeneity I 2 =0; P =0.44, n=3 studies). OAC therapy was not associated with an increased risk of recurrent ICrH (sRR, 1.44 [95% CI, 0.38-5.46], heterogeneity I 2 =70%, P =0.02, n=5 studies). Nonvitamin K antagonist OACs were more effective at reducing the risk of thromboembolic events (sRR, 0.65 [95% CI, 0.44-0.97], heterogeneity I 2 =72%, P =0.03, n=3 studies) and were associated with a lower risk of recurrent ICrH (sRR, 0.52 [95% CI, 0.40-0.67], heterogeneity I 2 =0%, P =0.43, n=3 studies) than warfarin., Conclusions: In nontraumatic ICrH survivors with atrial fibrillation, OAC therapy is associated with a reduced risk of thromboembolic events and all-cause mortality without significantly increasing risk of recurrent ICrH. This finding is primarily based on observational data, and further larger randomized controlled trials are needed to corroborate or refute these findings.

Background:  Stroke prevention in patients with atrial fibrillation (AF) post-intracerebral hemorrhage (ICH) is an area of clinical equipoise. Little is known about the tools and processes that physicians use to make decisions regarding anticoagulation in this high-risk patient population., Objective:  To explore physicians' decision-making process regarding stroke prevention in patients with AF and a recent history of ICH., Methods:  Qualitative study, utilizing semistructured interviews and analyzed using Framework analysis., Results:  Twenty physicians from five European countries (Austria, France, Germany, Spain, United Kingdom) participated. The overarching theme "Managing uncertainty," addressed the process of making high-risk clinical decisions in the context of little available robust clinical evidence for best practice. Three subthemes were identified under the umbrella theme: (1) "Computing the risks," captured the challenge of balancing the risks of ischemic stroke with the risk of recurrent ICH in a complex patient population; (2) "Patient factors" highlighted the influence that physician-perceived patients' beliefs and previous experience of stroke had on physicians' decisions; and (3) "Making a decision" explored the process of reaching a final decision regarding initiation of OAC therapy or not., Conclusion:  Physicians described the process of deciding on stroke prevention in patients with AF post-ICH as "challenging" due to considerable "clinical equipoise." Key factors that affected decision making were patient comorbidities, functional status, and patient willingness to engage with OAC therapy. Shared decision making was believed to be beneficial, but physicians believed that the ultimate responsibility to decide on stroke prevention lay with the clinician., Competing Interests: R.R.L.: None to declare. E.I.: A Research Associate on the PRESTIGE-AF study, which has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No. 754517. G.Y.H.L.: Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, and Daiichi-Sankyo. No fees are received personally. G.Y.H.L. is a co-investigator on the PRESTIGE-AF study, which has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No. 754517. D.A.L.: Investigator-initiated educational grants from Bristol Myers Squibb (BMS); been a speaker for Boehringer Ingelheim, Bayer, and BMS/Pfizer, and consulted for Boehringer Ingelheim, and BMS; all outside the submitted work. D.A.L. is a co-investigator on the PRESTIGE-AF study, which has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement No. 754517., (Thieme. All rights reserved.)

Aims: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and a key risk factor for ischaemic stroke. Following AF detection, treatment with oral anticoagulation can significantly lower mortality and morbidity rates associated with this risk. The availability of several hand-held devices which can detect AF may enable trained health professionals to adopt AF screening approaches which do not interfere with people's daily routines. This study aims to investigate the effectiveness of a hand-held device (the MyDiagnostick single-lead Electrocardiogram (ECG) sensor) in screening for AF when embedded into the handles of supermarket trolleys., Methods: A mixed methods two-phase approach will be taken. The quantitative first phase will involve the recruitment of 2000 participants from a convenience sample at four large supermarkets with pharmacies. Prospective participants will be asked to conduct their shopping using a trolley embedded with a MyDiagnostick sensor. If the device identifies a participant with AF, the in-store pharmacist will be dispatched to take a manual pulse measurement and a static control sensor reading and offer a cardiologist consultation referral. When the sensor does not detect AF, a researcher will confirm the reading with a manual pulse measurement. ECGs will be compiled, and the sensitivity, specificity and positive and negative predictive values will be determined. A qualitative second phase will consist of semi-structured interviews carried out with those pharmacists and store managers in-store during the running of the trial period. These will explore the perceptions of staff regarding the merits of embedding sensors in the handles of supermarket trolleys to detect AF., Conclusion: This feasibility study will inform a larger future definitive trial.

Introduction: Managing risk is central to clinical care, yet most research focuses on patient perception, as opposed to how risk is enacted within the clinical setting by healthcare professionals., Aim: To explore how surgical risk is perceived, encountered, and managed by congenital cardiac surgeons., Methods: Semi-structured interviews were conducted with 20 congenital cardiac surgeons representing every unit across England and Wales. All interviews were transcribed verbatim, with analysis based on the constant comparative approach., Findings: Three themes were identified, reflecting the interactions between personal, institutional, and political context in which risk is encountered and managed. First, "communicating risk" highlights the complexity and variability in methods employed by surgeons to balance legal/moral obligations with parental need and expectations. Universally, surgeons described the need for flexibility in their approach in order to meet the needs of individual patients. Second, "scrutiny and accountability" captures the spectrum of opinion arising from the binary nature of the outcomes collated and the way in which they are perceived to be interpreted. Third, "nature of the job" highlights the personal and professional implications of conveying and managing risk and the impact of recent policy changes on the way this is enacted., Conclusion: Variations in approaches to communicating risk demonstrate a lack of consensus, compounded by insufficient evidence to determine or monitor a "best-care" approach. With current surgical outcomes suggesting little room for increasing survival rates, future care needs should shift to the "soft skills" in order to continue to drive improvements in parental and patient experience.

Introduction: The way risk is interpreted by parents of children undergoing congenital cardiac surgery is poorly documented. Literature suggests clinicians have concerns that parents may not understand the complexity of procedures. Conversely, some parents perceive an unnecessary over-emphasis of risks., Aim: To explore how risk is encountered by parents of children who are undergoing cardiac surgery, in order to deliver effective and compassionate care., Methods: A qualitative approach was adopted. Interviews were undertaken with 18 parents (mothers n = 10; fathers n = 8). Recordings were transcribed verbatim and analysed using a constant comparative-based approach., Findings: Three themes emerged from the data: the nature of risk, reflecting the complexity of parental perception of risk and the influence of the doctor-parent relationship; presenting risk, highlighting the way in which risk is presented to and interpreted by parents; and risk and responsibility, examining the way in which parents engaged with risk and the impact of this on their relationship., Conclusions: The way in which risk is perceived by parents is complex and multi-factorial. The doctor-parent relationship is key to parental engagement. However, parents manage risk and uncertainty through a number of mechanisms, including those perceived as being not rational. This can cause tension, particularly when required to engage in informed decision-making.

Hospitalization impacts negatively on oral health, where underlying medical conditions and interventions such as oxygen therapy and nil-by-mouth status increase susceptibility to complications. However, evidence suggests it is often overlooked, or viewed as low priority by nurses. The rationale for these beliefs is unclear. This study provides an exploration of these beliefs, focusing specifically on their development, as reflected in the experiences of adult and paediatric student nurses. Three focus groups were conducted, and thematic analysis applied. Whilst students theoretically understood the value of oral health care, in hospital it was overlooked, with other 'clinical' aspects of care valued more highly. 'Hierarchy of need' emerged as the over-arching theme. Interrelated sub-themes included: 'practice/theory mismatch,' highlighting lack of education and adequacy of exposure to oral health care encounters; 'resources,' where infrastructure was lacking; and 'disempowerment,' where students felt powerless to act. Exposure to oral health care encounters were less frequent in the paediatric setting, risking disempowerment of parents as well as students. These findings highlight the need to raise the profile of oral health care, both theoretically and practically, engendering a culture that embeds mouth care unobtrusively into day-to-day nursing practice, improving health care outcomes for those in our care., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objective: To investigate socioeconomic inequalities in outcome of pregnancy associated with Down syndrome (DS) compared with other congenital anomalies screened for during pregnancy., Design and Setting: Retrospective population-based registry study (East Midlands & South Yorkshire in England)., Participants: All registered cases of DS and nine selected congenital anomalies with poor prognostic outcome (the UK Fetal Anomaly Screening Programme (FASP)9) with an end of pregnancy date between 1 January 1998 and 31 December 2007., Main Outcome Measures: Poisson regression models were used to explore outcome measures, including socioeconomic variation in rates of anomaly; antenatal detection; pregnancy outcome; live birth incidence and neonatal mortality. Deprivation was measured using the Index of Multiple Deprivation 2004 at super output area level., Results: There were 1151 cases of DS and 1572 cases of the nine severe anomalies combined. The overall rate of antenatal detection was 57% for DS, which decreased with increasing deprivation (rate ratio comparing the most deprived tenth with the least deprived: 0.76 (0.60 to 0.97)). Antenatal detection rates were considerably higher for FASP9 anomalies (86%), with no evidence of a trend with deprivation (0.99 95% CI (0.84 to 1.17)). The termination of pregnancy rate following antenatal diagnosis was higher for DS (86%) than the FASP9 anomalies (70%). Both groups showed wide socioeconomic variation in the termination of pregnancy rate (rate ratio: DS: 0.76 (0.58 to 0.99); FASP9 anomalies: 0.80 (0.65 to 0.97)). Consequently, socioeconomic inequalities in live birth and neonatal mortality rates associated with these anomalies arise that were not observed in utero., Conclusions: Socioeconomic inequalities exist in the antenatal detection of DS, and subsequent termination rates are much higher for DS than other anomalies. Termination rates for all anomalies are lower in more deprived areas leading to wide socioeconomic inequalities in live born infants with a congenital anomaly, particularly DS, and subsequent neonatal mortality., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)