ItemIntravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial(Elsevier, 2022-11-04) Kalra, P. R.; Cleland, J. G. F.; Petrie, M. C.; Thomson, E. A.; Kalra, P. A.; Squire, I. B.; Ahmed, F. Z.; Al-Mohammad, A.; Cowburn, P. J.; Foley, P. W. X.; Graham, F. J.; Japp, A. G.; Lane, R. E.; Lang, N. N.; Ludman, A. J.; Macdougall, I. C.; Pellicori, P.; Ray, R.; Robertson, M.; Seed, A.; Ford, I.BACKGROUND: For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the short-term and reduces hospital admissions for heart failure up to 1 year. We aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure. METHODS: IRONMAN was a prospective, randomised, open-label, blinded-endpoint trial done at 70 hospitals in the UK. Patients aged 18 years or older with heart failure (left ventricular ejection fraction ≤45%) and transferrin saturation less than 20% or serum ferritin less than 100 μg/L were eligible. Participants were randomly assigned (1:1) using a web-based system to intravenous ferric derisomaltose or usual care, stratified by recruitment context and trial site. The trial was open label, with masked adjudication of the outcomes. Intravenous ferric derisomaltose dose was determined by patient bodyweight and haemoglobin concentration. The primary outcome was recurrent hospital admissions for heart failure and cardiovascular death, assessed in all validly randomly assigned patients. Safety was assessed in all patients assigned to ferric derisomaltose who received at least one infusion and all patients assigned to usual care. A COVID-19 sensitivity analysis censoring follow-up on Sept 30, 2020, was prespecified. IRONMAN is registered with ClinicalTrials.gov, NCT02642562. FINDINGS: Between Aug 25, 2016, and Oct 15, 2021, 1869 patients were screened for eligibility, of whom 1137 were randomly assigned to receive intravenous ferric derisomaltose (n=569) or usual care (n=568). Median follow-up was 2·7 years (IQR 1·8-3·6). 336 primary endpoints (22·4 per 100 patient-years) occurred in the ferric derisomaltose group and 411 (27·5 per 100 patient-years) occurred in the usual care group (rate ratio [RR] 0·82 [95% CI 0·66 to 1·02]; p=0·070). In the COVID-19 analysis, 210 primary endpoints (22·3 per 100 patient-years) occurred in the ferric derisomaltose group compared with 280 (29·3 per 100 patient-years) in the usual care group (RR 0·76 [95% CI 0·58 to 1·00]; p=0·047). No between-group differences in deaths or hospitalisations due to infections were observed. Fewer patients in the ferric derisomaltose group had cardiac serious adverse events (200 [36%]) than in the usual care group (243 [43%]; difference -7·00% [95% CI -12·69 to -1·32]; p=0·016). INTERPRETATION: For a broad range of patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric derisomaltose administration was associated with a lower risk of hospital admissions for heart failure and cardiovascular death, further supporting the benefit of iron repletion in this population. FUNDING: British Heart Foundation and Pharmacosmos. ItemPatient and public involvement and engagement with cardiac arrest survivors(The College of Paramedics, 2022-06-01) Coppola, A.; Halliday, C.; Jones, M.; Houghton, R.; Johnson, M.; Sillis, N.; Johnson, M.; Sillis, D.; Endacott, R.BACKGROUND: Patient and public involvement and engagement (PPIE) with cardiac arrest survivors is an essential component of research to strengthen development, design, delivery and dissemination to ensure research priorities are in the public interest and patient friendly. Cardiac arrest survivors and their relatives were engaged in PPIE to help develop the methods of a research study that aims to reduce individual and care process variation during paramedic-led resuscitation. METHODS: This research methodology paper represents the views of seven PPIE representatives and the authors. PPIE representatives included five cardiac arrest survivors and two relatives. Content for the paper was generated by discussion using audio or video call. Notes were taken by the author which included direct quotations generated by the PPIE process. RESULTS: The PPIE representatives considered research surrounding the decisions made by paramedics to be important. From their first-hand experiences, survivors and their relatives felt that a future research study should focus on patient survival. The decision-making of paramedics was identified as most important to explore. Quality of life before the cardiac arrest was considered important as this may help to inform best-interest decisions. The neurologic recovery of patients was important; however, rehabilitation may be extensive and therefore unachievable within the study timeframe. Relatives highlighted that while incorporating their views during resuscitation was important, gaining consent for research participation was not appropriate. CONCLUSION: PPIE added value and helped to develop a future study to reduce variation in the resuscitation decisions made by paramedics. The group identified what is important to survivors and their relatives and the factors they would like paramedics to consider when making a resuscitation decision. By identifying these factors, the PPIE process has helped to drive the research methods where both quantitative and qualitative designs would be appropriate. Issues in gaining research consent during resuscitation were highlighted. ItemLongitudinal comparisons of mental health, burnout and well-being in patient-facing, non-patient-facing healthcare professionals and non-healthcare professionals during the COVID-19 pandemic: findings from the CoPE-HCP study(Cambridge University Press, 2022-09-27) Kapil, V.; Collett, G.; Godec, T.; Gupta, J.; Maniero, C.; Ng, S. M.; McIntosh, I.; Kumar, A.; Nair, S.; Kotecha, A.; Janmohamed, A.; Antoniou, S.; Khan, R.; Khanji, M. Y.; Siddiqui, I.; Gupta, A.BACKGROUND: The COVID-19 pandemic may disproportionately affect the mental health of healthcare professionals (HCPs), especially patient-facing HCPs. AIMS: To longitudinally examine mental health in HCPs versus non-HCPs, and patient-facing HCPs versus non-patient-facing HCPs. METHOD: Online surveys were distributed to a cohort at three phases (baseline, July to September 2020; phase 2, 6 weeks post-baseline; phase 3, 4 months post-baseline). Each survey contained validated assessments for depression, anxiety, insomnia, burnout and well-being. For each outcome, we conducted mixed-effects logistic regression models (adjusted for a priori confounders) comparing the risk in different groups at each phase. RESULTS: A total of 1574 HCPs and 147 non-HCPs completed the baseline survey. Although there were generally higher rates of various probable mental health issues among HCPs versus non-HCPs at each phase, there was no significant difference, except that HCPs had 2.5-fold increased risk of burnout at phase 2 (emotional exhaustion: odds ratio 2.50, 95% CI 1.15-5.46, P = 0.021), which increased at phase 3 (emotional exhaustion: odds ratio 3.32, 95% CI 1.40-7.87, P = 0.006; depersonalisation: odds ratio 3.29, 95% CI 1.12-9.71, P = 0.031). At baseline, patient-facing HCPs (versus non-patient-facing HCPs) had a five-fold increased risk of depersonalisation (odds ratio 5.02, 95% CI 1.65-15.26, P = 0.004), with no significant difference in the risk for other outcomes. The difference in depersonalisation reduced over time, but patient-facing HCPs still had a 2.7-fold increased risk of emotional exhaustion (odds ratio 2.74, 95% CI 1.28-5.85, P = 0.009) by phase 3. CONCLUSIONS: The COVID-19 pandemic had a huge impact on the mental health and well-being of both HCPs and non-HCPs, but there is disproportionately higher burnout among HCPs, particularly patient-facing HCPs. ItemPost-Partum Spontaneous Coronary Artery Dissection with Occluded Left Anterior Descending Artery(Irish Medical Association, 2022-03-16) Davies, T.; He, J.; Hawley, A.; Dyer, B.; George, A.Presentation We present a case of spontaneous coronary artery dissection (SCAD) in a 35-year-old lady who was 4 months post-partum. Despite a lack of typical risk factors, initial presentation and investigations were strongly suggestive of ACS. Diagnosis Coronary angiography revealed an occluded proximal left anterior descending (LAD) artery with TIMI 0 flow. Angiographic appearances and intravascular ultrasound (IVUS) were consistent with SCAD. Treatment A single drug-eluting stent was deployed, successfully restoring good flow, without extending the dissection flap. Discussion SCAD should be considered as an important and underdiagnosed cause of ACS, predominantly in young women without other apparent risk factors. ItemMorphological and functional cardiac consequences of rapid hypertension treatment: a cohort study(BioMed Central, 2021-10-25) Jordan, A. N.; Fulford, J.; Gooding, K.; Anning, C.; Wilkes, L.; Ball, C.; Pamphilon, N.; Mawson, D.; Clark, C. E.; Shore, A. C.; Sharp, A. S. P.; Bellenger, N. G.BACKGROUND: Left ventricular (LV) hypertrophy (LVH) in uncontrolled hypertension is an independent predictor of mortality, though its regression with treatment improves outcomes. Retrospective data suggest that early control of hypertension provides a prognostic advantage and this strategy is included in the 2018 European guidelines, which recommend treating grade II/III hypertension to target blood pressure (BP) within 3 months. The earliest LVH regression to date was demonstrated by echocardiography at 24 weeks. The effect of a rapid guideline-based treatment protocol on LV remodelling, with very early BP control by 18 weeks remains controversial and previously unreported. We aimed to determine whether such rapid hypertension treatment is associated with improvements in LV structure and function through paired cardiovascular magnetic resonance (CMR) scanning at baseline and 18 weeks, utilising CMR mass and feature tracking analysis. METHODS: We recruited participants with never-treated grade II/III hypertension, initiating a guideline-based treatment protocol which aimed to achieve BP control within 18 weeks. CMR and feature tracking were used to assess myocardial morphology and function immediately before and after treatment. RESULTS: We acquired complete pre- and 18-week post-treatment data for 41 participants. During the interval, LV mass index reduced significantly (43.5 ± 9.8 to 37.6 ± 8.3 g/m(2), p < 0.001) following treatment, accompanied by reductions in LV ejection fraction (65.6 ± 6.8 to 63.4 ± 7.1%, p = 0.03), global radial strain (46.1 ± 9.7 to 39.1 ± 10.9, p < 0.001), mid-circumferential strain (- 20.8 ± 4.9 to - 19.1 ± 3.7, p = 0.02), apical circumferential strain (- 26.0 ± 5.3 to - 23.4 ± 4.2, p = 0.003) and apical rotation (9.8 ± 5.0 to 7.5 ± 4.5, p = 0.003). CONCLUSIONS: LVH regresses following just 18 weeks of intensive antihypertensive treatment in subjects with newly-diagnosed grade II/III hypertension. This is accompanied by potentially advantageous functional changes within the myocardium and supports the hypothesis that rapid treatment of hypertension could improve clinical outcomes. TRIAL REGISTRATION: ISRCTN registry number: 57475376 (assigned 25/06/2015).