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The Western Australian mining industry is a global supplier of critical minerals, including lithium and rare earths. The lithology of these minerals is associated with elevated concentrations of naturally occurring radionuclides (NORs). An increase in the number of mines producing the minerals has witnessed a commensurate increase in the number of workers potentially exposed to the radiation from NORs. The regulatory framework in Western Australia underwent significant change in March 2022. Mining operations whose workers are likely to receive doses greater than one mSvy-1 are referenced as relevant mines and are required to submit an annual report of worker doses to the mining regulator. This research provides an overview of the new legislative framework and updates the information in Ralph and Cattani (2022) to include data derived from annual radiation doses reported by relevant mines in the period spanning 2020-21 to 2022-23. In 2022-23, 38 mining operations were identified as relevant mines, an increase of sixteen from 2020-21. The mean effective dose (ED) reported in the three-year period was 1.0 mSv, and the maximum ED was 4.9 mSv. The collective effective dose of the mine worker population reached an historical maximum of 2,339 man.mSv in 2022-23. Inhalation of long-lived alpha emitting radionuclides in dust remains the most significant contributor to worker doses. Inhalation of radon-22, radon-220 and their short-lived progeny, once considered as a negligible contributor to worker doses, is the second most significant exposure pathway. A declining trend in the number of samples collected per worker is highlighted as requiring remediation to provide confidence in the reported dose estimates. The transition to the new legislative framework for radiation protection in mines has been supported by the publication of guidance materials which have been widely endorsed by the industry. .
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The aim of this document is to provide guidance for the management of women and birthing people with a permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD). Cardiac devices are becoming more common in obstetric practice and a reference document for contemporary evidence-based practice is required. Where evidence is limited, expert consensus has established recommendations. The purpose is to improve safety and reduce the risk of adverse events relating to implanted cardiac devices during pregnancy, birth and the postnatal period.
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AIMS: The randomized, double-blind, placebo-controlled HOPE-HF trial assessed the benefit of atrio-ventricular (AV) delay optimization delivered using His bundle pacing. It recruited patients with left ventricular ejection fraction ≤40%, PR interval ≥200 ms, and baseline QRS ≤140 ms or right bundle branch block. Overall, there was no significant increase in peak oxygen uptake (VO2max) but there was significant improvement in heart failure specific quality of life. In this pre-specified secondary analysis, we evaluated the impact of baseline PR interval, echocardiographic E-A fusion, and the magnitude of acute high-precision haemodynamic response to pacing, on outcomes. METHODS AND RESULTS: All 167 randomized participants underwent measurement of PR interval, acute haemodynamic response at optimized AV delay, and assessment of presence of E-A fusion. We tested the impact of these baseline parameters using a Bayesian ordinal model on VO2max, quality of life and activity measures. There was strong evidence of a beneficial interaction between the baseline acute haemodynamic response and the blinded benefit of pacing for VO2 (Pr 99.9%), Minnesota Living With Heart Failure (MLWHF) (Pr 99.8%), MLWHF physical limitation score (Pr 98.9%), EQ-5D visual analogue scale (Pr 99.6%), and exercise time (Pr 99.4%). The baseline PR interval and the presence of baseline E-A fusion did not have this reliable ability to predict the clinical benefit of pacing over placebo across multiple endpoints. CONCLUSIONS: In the HOPE-HF trial, the acute haemodynamic response to pacing reliably identified patients who obtained clinical benefit. Patients with a long PR interval (≥200 ms) and left ventricular impairment who obtained acute haemodynamic improvement with AV-optimized His bundle pacing were likely to obtain clinical benefit, consistent across multiple endpoints. Importantly, this gradation can be reliably tested for before randomization, but does require high-precision AV-optimized haemodynamic assessment to be performed.
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This updated guidance is designed to help with implantation and follow-up with agreed standards of practice. The update includes new guidance on subcutaneous defibrillators, leadless pacemakers and conduction system pacing. It includes new guidance on considerations at the time of a potential box change and techniques to be considered to minimise the risk of infection.
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BACKGROUND AND AIMS: What is the relationship between blood tests for iron deficiency, including anaemia, and the response to intravenous iron in patients with heart failure? METHODS: In the IRONMAN trial, 1137 patients with heart failure, ejection fraction ≤ 45%, and either serum ferritin < 100â µg/L or transferrin saturation (TSAT) < 20% were randomized to intravenous ferric derisomaltose (FDI) or usual care. Relationships were investigated between baseline anaemia severity, ferritin and TSAT, to changes in haemoglobin from baseline to 4 months, Minnesota Living with Heart Failure (MLwHF) score and 6-minute walk distance achieved at 4 months, and clinical events, including heart failure hospitalization (recurrent) or cardiovascular death. RESULTS: The rise in haemoglobin after administering FDI, adjusted for usual care, was greater for lower baseline TSAT (Pinteraction < .0001) and ferritin (Pinteraction = .028) and more severe anaemia (Pinteraction = .014). MLwHF scores at 4 months were somewhat lower (better) with FDI for more anaemic patients (overall Pinteraction = .14; physical Pinteraction = .085; emotional Pinteraction = .043) but were not related to baseline TSAT or ferritin. Blood tests did not predict difference in achieved walking distance for those randomized to FDI compared to control. The absence of anaemia or a TSAT ≥ 20% was associated with lower event rates and little evidence of benefit from FDI. More severe anaemia or TSAT < 20%, especially when ferritin was ≥100â µg/L, was associated with higher event rates and greater absolute reductions in events with FDI, albeit not statistically significant. CONCLUSIONS: This hypothesis-generating analysis suggests that anaemia or TSAT < 20% with ferritin > 100â µg/L might identify patients with heart failure who obtain greater benefit from intravenous iron. This interpretation requires confirmation.
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Anemia Ferropénica , Anemia , Insuficiencia Cardíaca , Deficiencias de Hierro , Humanos , Hierro/uso terapéutico , Anemia Ferropénica/tratamiento farmacológico , Ferritinas/uso terapéutico , Compuestos Férricos/uso terapéutico , Hemoglobinas , Insuficiencia Cardíaca/tratamiento farmacológicoRESUMEN
BACKGROUND: Major vascular involvement is often considered a contraindication to resection of malignant tumors, but in highly selected patients, it can be performed safely, with results that are highly dependent upon the tumor biology. Resection of both the aorta and inferior vena cava (IVC) is a rare undertaking, requiring both favorable tumor biology and a patient fit for a substantial surgical insult; nevertheless, it provides the possibility of a cure. METHODS: Patients requiring resection and reconstruction of both the aorta and IVC from 2009 through 2019 at 2 university medical centers were included. Patient characteristics, operative technique, and outcomes were retrospectively collected. RESULTS: We identified 9 patients, all with infrarenal reconstruction or repair of the aorta and IVC. All cases were performed with systemic heparinization and required simultaneous aortic and caval cross-clamping for tumor resection. No temporary venous or arterial bypass was used. Since arterial reperfusion with the IVC clamped was poorly tolerated in 1 patient, venous reconstruction was typically completed first. Primary repair was performed in 1 patient, while 8 required replacements. In 2 patients, aortic homograft was used for replacement of both the aortoiliac and iliocaval segments in contaminated surgical fields. In the remaining 6, Dacron was used for arterial replacement; either Dacron (n = 2) or polytetrafluoroethylene (n = 4) were used for venous replacement. Patients were discharged after a median stay of 8 days (range: 5-16). At median follow-up of 17 months (range 3-79 months), 2 patients with paraganglioma and 1 patient with Leydig cell carcinoma had cancer recurrences. Venous reconstructions occluded in 3 patients (38%), although symptoms were minimal. One patient presented acutely with a thrombosed iliac artery limb and bilateral common iliac artery anastomotic stenoses, treated successfully with thrombolysis and stenting. CONCLUSIONS: Patients with tumor involving both the aorta and IVC can be successfully treated with resection and reconstruction. En bloc tumor resection, restoration of venous return before arterial reconstruction, and most importantly, careful patient selection, all contribute to positive outcomes in this otherwise incurable population.
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Implantación de Prótesis Vascular , Neoplasias Retroperitoneales , Humanos , Neoplasias Retroperitoneales/diagnóstico por imagen , Neoplasias Retroperitoneales/cirugía , Neoplasias Retroperitoneales/patología , Resultado del Tratamiento , Estudios Retrospectivos , Tereftalatos Polietilenos , Implantación de Prótesis Vascular/efectos adversos , Recurrencia Local de Neoplasia/patología , Recurrencia Local de Neoplasia/cirugía , Vena Cava Inferior/diagnóstico por imagen , Vena Cava Inferior/cirugía , Vena Cava Inferior/patología , Aorta/diagnóstico por imagen , Aorta/cirugía , Aorta/patologíaRESUMEN
INTRODUCTION: Severe aortic stenosis is a major cause of morbidity and mortality. The existing treatment pathway for transcatheter aortic valve implantation (TAVI) traditionally relies on tertiary Heart Valve Centre workup. However, this has been associated with delays to treatment, in breach of British Cardiovascular Intervention Society targets. A novel pathway with emphasis on comprehensive patient workup at a local centre, alongside close collaboration with a Heart Valve Centre, may help reduce the time to TAVI. METHODS: The centre performing local workup implemented a novel TAVI referral pathway. Data were collected retrospectively for all outpatients referred for consideration of TAVI to a Heart Valve Centre from November 2020 to November 2021. The main outcome of time to TAVI was calculated as the time from Heart Valve Centre referral to TAVI, or alternative intervention, expressed in days. For the centre performing local workup, referral was defined as the date of multidisciplinary team discussion. For this centre, a total pathway time from echocardiographic diagnosis to TAVI was also evaluated. A secondary outcome of the proportion of referrals proceeding to TAVI at the Heart Valve Centre was analysed. RESULTS: Mean±SD time from referral to TAVI was significantly lower at the centre performing local workup, when compared with centres with traditional referral pathways (32.4±64 to 126±257 days, p<0.00001). The total pathway time from echocardiographic diagnosis to TAVI for the centre performing local workup was 89.9±67.6 days, which was also significantly shorter than referral to TAVI time from all other centres (p<0.003). Centres without local workup had a significantly lower percentage of patients accepted for TAVI (49.5% vs 97.8%, p<0.00001). DISCUSSION: A novel TAVI pathway with emphasis on local workup within a non-surgical centre significantly reduced both the time to TAVI and rejection rates from a Heart Valve Centre. If adopted across the other centres, this approach may help improve access to TAVI.
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Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Estudios Retrospectivos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Ecocardiografía , Pacientes Ambulatorios , Derivación y ConsultaRESUMEN
BACKGROUND AND AIMS: To examine the decongestive effect of the sodium-glucose cotransporter 2 inhibitor dapagliflozin compared to the thiazide-like diuretic metolazone in patients hospitalized for heart failure and resistant to treatment with intravenous furosemide. METHODS AND RESULTS: A multi-centre, open-label, randomized, and active-comparator trial. Patients were randomized to dapagliflozin 10 mg once daily or metolazone 5-10 mg once daily for a 3-day treatment period, with follow-up for primary and secondary endpoints until day 5 (96 h). The primary endpoint was a diuretic effect, assessed by change in weight (kg). Secondary endpoints included a change in pulmonary congestion (lung ultrasound), loop diuretic efficiency (weight change per 40 mg of furosemide), and a volume assessment score. 61 patients were randomized. The mean (±standard deviation) cumulative dose of furosemide at 96 h was 977 (±492) mg in the dapagliflozin group and 704 (±428) mg in patients assigned to metolazone. The mean (±standard deviation) decrease in weight at 96 h was 3.0 (2.5) kg with dapagliflozin compared to 3.6 (2.0) kg with metolazone [mean difference 0.65, 95% confidence interval (CI) -0.12,1.41 kg; P = 0.11]. Loop diuretic efficiency was less with dapagliflozin than with metolazone [mean 0.15 (0.12) vs. 0.25 (0.19); difference -0.08, 95% CI -0.17,0.01 kg; P = 0.10]. Changes in pulmonary congestion and volume assessment score were similar between treatments. Decreases in plasma sodium and potassium and increases in urea and creatinine were smaller with dapagliflozin than with metolazone. Serious adverse events were similar between treatments. CONCLUSION: In patients with heart failure and loop diuretic resistance, dapagliflozin was not more effective at relieving congestion than metolazone. Patients assigned to dapagliflozin received a larger cumulative dose of furosemide but experienced less biochemical upset than those assigned to metolazone. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04860011.
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Insuficiencia Cardíaca , Metolazona , Humanos , Metolazona/uso terapéutico , Metolazona/efectos adversos , Inhibidores del Simportador de Cloruro Sódico y Cloruro Potásico/uso terapéutico , Furosemida/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/inducido químicamente , Diuréticos/uso terapéutico , SodioRESUMEN
AIMS: The field of conduction system pacing (CSP) is evolving, and our aim was to obtain a contemporary picture of European CSP practice. METHODS AND RESULTS: A survey was devised by a European CSP Expert Group and sent electronically to cardiologists utilizing CSP. A total of 284 physicians were invited to contribute of which 171 physicians (60.2%; 85% electrophysiologists) responded. Most (77%) had experience with both His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP). Pacing indications ranked highest for CSP were atrioventricular block (irrespective of left ventricular ejection fraction) and when coronary sinus lead implantation failed. For patients with left bundle branch block (LBBB) and heart failure (HF), conventional biventricular pacing remained first-line treatment. For most indications, operators preferred LBBAP over HBP as a first-line approach. When HBP was attempted as an initial approach, reasons reported for transitioning to utilizing LBBAP were: (i) high threshold (reported as >2â V at 1â ms), (ii) failure to reverse bundle branch block, or (iii) > 30â min attempting to implant at His-bundle sites. Backup right ventricular lead use for HBP was low (median 20%) and predominated in pace-and-ablate scenarios. Twelve-lead electrocardiogram assessment was deemed highly important during follow-up. This, coupled with limitations from current capture management algorithms, limits remote monitoring for CSP patients. CONCLUSIONS: This survey provides a snapshot of CSP implementation in Europe. Currently, CSP is predominantly used for bradycardia indications. For HF patients with LBBB, most operators reserve CSP for biventricular implant failures. Left bundle branch area pacing ostensibly has practical advantages over HBP and is therefore preferred by many operators. Practical limitations remain, and large randomized clinical trial data are currently lacking.
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Terapia de Resincronización Cardíaca , Insuficiencia Cardíaca , Humanos , Volumen Sistólico/fisiología , Función Ventricular Izquierda , Resultado del Tratamiento , Sistema de Conducción Cardíaco , Bloqueo de Rama/diagnóstico , Bloqueo de Rama/terapia , Arritmias Cardíacas/terapia , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapiaRESUMEN
AIMS: Excessive prolongation of PR interval impairs coupling of atrio-ventricular (AV) contraction, which reduces left ventricular pre-load and stroke volume, and worsens symptoms. His bundle pacing allows AV delay shortening while maintaining normal ventricular activation. HOPE-HF evaluated whether AV optimized His pacing is preferable to no-pacing, in a double-blind cross-over fashion, in patients with heart failure, left ventricular ejection fraction (LVEF) ≤40%, PR interval ≥200 ms and either QRS ≤140 ms or right bundle branch block. METHODS AND RESULTS: Patients had atrial and His bundle leads implanted (and an implantable cardioverter-defibrillator lead if clinically indicated) and were randomized to 6 months of pacing and 6 months of no-pacing utilizing a cross-over design. The primary outcome was peak oxygen uptake during symptom-limited exercise. Quality of life, LVEF and patients' holistic symptomatic preference between arms were secondary outcomes. Overall, 167 patients were randomized: 90% men, 69 ± 10 years, QRS duration 124 ± 26 ms, PR interval 249 ± 59 ms, LVEF 33 ± 9%. Neither peak oxygen uptake (+0.25 ml/kg/min, 95% confidence interval [CI] -0.23 to +0.73, p = 0.3) nor LVEF (+0.5%, 95% CI -0.7 to 1.6, p = 0.4) changed with pacing but Minnesota Living with Heart Failure quality of life improved significantly (-3.7, 95% CI -7.1 to -0.3, p = 0.03). Seventy-six percent of patients preferred His bundle pacing-on and 24% pacing-off (p < 0.0001). CONCLUSION: His bundle pacing did not increase peak oxygen uptake but, under double-blind conditions, significantly improved quality of life and was symptomatically preferred by the clear majority of patients. Ventricular pacing delivered via the His bundle did not adversely impact ventricular function during the 6 months.
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Terapia de Resincronización Cardíaca , Insuficiencia Cardíaca , Masculino , Humanos , Femenino , Fascículo Atrioventricular , Estudios Cruzados , Volumen Sistólico , Calidad de Vida , Tolerancia al Ejercicio , Función Ventricular Izquierda , Oxígeno , Resultado del Tratamiento , Estimulación Cardíaca Artificial/métodos , Terapia de Resincronización Cardíaca/métodos , Electrocardiografía/métodosRESUMEN
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.
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Anemia Ferropénica , COVID-19 , Insuficiencia Cardíaca , Deficiencias de Hierro , Humanos , Volumen Sistólico , Anemia Ferropénica/tratamiento farmacológico , Anemia Ferropénica/complicaciones , Calidad de Vida , Estudios Prospectivos , Función Ventricular Izquierda , COVID-19/complicaciones , Reino Unido/epidemiología , Resultado del TratamientoRESUMEN
Pacemakers are a key technology in the treatment of bradyarrhythmias. Leadless pacemakers (LP) were introduced to address limitations of transvenous devices. However, guidelines and other restrictions have led to LPs becoming niche products. The aim of this consensus statement was to determine the strength of opinion of UK implantation experts as to how LPs can be more optimally used. Using a modified Delphi approach, a panel of LP experts developed 36 statements that were used to form a survey that was distributed to LP implanters in the UK. Stopping criteria included a 3-month window for response, a minimum 25% response rate and at least 75% of statements achieving the threshold for consensus (agreed at 66%). In all, 31 of 36 statements reached consensus, and 23 of these achieved ≥90% agreement. Five statements did not achieve consensus. On the basis of these results, seven recommendations were proposed. The implementation of these recommendations may increase the use of LPs, with the aim of improving patient outcomes.
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Background: Lamin A/C (LMNA) mutations account for 5-8% of familial dilated cardiomyopathies, and can manifest with conduction abnormalities and ventricular arrhythmias in 78% of patients. Therefore, when suspected, it is important to implant the correct type of device. Case summary: A 52-year-old gentleman with a family history of cardiomyopathy, presented with asymptomatic atrial fibrillation and complete atrioventricular block associated with a narrow QRS interval. Investigations confirmed dilated and severely impaired left ventricular systolic function. He underwent successful conduction system pacing in combination with a primary prevention defibrillator. Genetic screening confirmed LMNA cardiomyopathy. During 3 years follow up, his left ventricular function remained unchanged with stable conduction system capture and he received appropriate therapy from his device for ventricular tachycardia. Discussion: His-bundle pacing promotes rapid and synchronous activation of the ventricles via the intrinsic conduction system of the heart. In selected individuals with LMNA cardiomyopathy, conduction system pacing is viable alternative to conventional cardiac resynchronization therapy using coronary sinus tributaries.
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OBJECTIVES: For patients with a reduced left ventricular ejection fraction (LVEF) heart failure with reduced ejection fraction (HFrEF) and iron deficiency, administration of intravenous iron improves symptoms, exercise capacity and may in the following 12 months, reduce hospitalisations for heart failure. The Effectiveness of Intravenous iron treatment versus standard care in patients with heart failure and iron deficiency (IRONMAN) trial evaluated whether the benefits of intravenous iron persist in the longer term and impact on morbidity and mortality. METHODS: IRONMAN is a prospective, randomised, open-label, blinded endpoint (PROBE) event-driven trial. Patients aged ≥18 years with HFrEF (LVEF ≤45%) and evidence of iron deficiency (ferritin <100 µg/L and/or TSAT <20%) were enrolled if they had either a current or recent hospitalisation for heart failure or elevated plasma concentrations of a natriuretic peptide. Participants were randomised to receive, or not to receive, intravenous ferric derisomaltose in addition to guideline-recommended therapy for HFrEF. Every 4 months, intravenous iron was administered if either ferritin was <100 µg/L or, provided ferritin was ≤400 µg/L, TSAT was <25%. The primary endpoint is a composite of total hospitalisations for heart failure and cardiovascular death. Hospitalisation and deaths due to infection are safety endpoints. RESULTS: Trial recruitment was completed across 70 UK hospital sites in October 2021. Participants were followed until the end of March 2022. We plan to report the results by November 2022. CONCLUSIONS: IRONMAN will determine whether repeated doses of intravenous ferric derisomaltose are beneficial and safe for the long-term treatment of a broad range of patients with HFrEF and iron deficiency. TRIAL REGISTRATION NUMBER: NCT02642562.
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Insuficiencia Cardíaca Sistólica , Insuficiencia Cardíaca , Deficiencias de Hierro , Humanos , Adolescente , Adulto , Volumen Sistólico , Hierro , Estudios Prospectivos , Función Ventricular Izquierda , Ferritinas/uso terapéuticoRESUMEN
Iron has a long and storied history in Parkinson disease and related disorders. This essential micronutrient is critical for normal brain function, but abnormal brain iron accumulation has been associated with extrapyramidal disease for a century. Precisely why, how, and when iron is implicated in neuronal death remains the subject of investigation. In this article, we review the history of iron in movement disorders, from the first observations in the early twentieth century to recent efforts that view extrapyramidal iron as a novel therapeutic target and diagnostic indicator.
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Enfermedades de los Ganglios Basales , Enfermedad de Parkinson , Encéfalo , Humanos , Hierro , Enfermedad de Parkinson/complicaciones , Sustancia NegraRESUMEN
BACKGROUND: Increasing evidence supports a link between myocardial fibrosis (MF) and ventricular arrhythmias. OBJECTIVES: The purpose of this study was to determine whether presence of myocardial fibrosis on visual assessment (MFVA) and gray zone fibrosis (GZF) mass predicts sudden cardiac death (SCD) and ventricular fibrillation/sustained ventricular tachycardia after cardiac implantable electronic device (CIED) implantation. METHODS: In this prospective study, total fibrosis and GZF mass, quantified using cardiovascular magnetic resonance, was assessed in relation to the primary endpoint of SCD and the secondary, arrhythmic endpoint of SCD or ventricular arrhythmias after CIED implantation. RESULTS: Among 700 patients (age 68.0 ± 12.0 years), 27 (3.85%) experienced a SCD and 121 (17.3%) met the arrhythmic endpoint over median 6.93 years (IQR: 5.82-9.32 years). MFVA predicted SCD (HR: 26.3; 95% CI: 3.7-3,337; negative predictive value: 100%). In competing risk analyses, MFVA also predicted the arrhythmic endpoint (subdistribution HR: 19.9; 95% CI: 6.4-61.9; negative predictive value: 98.6%). Compared with no MFVA, a GZF mass measured with the 5SD method (GZF5SD) >17 g was associated with highest risk of SCD (HR: 44.6; 95% CI: 6.12-5,685) and the arrhythmic endpoint (subdistribution HR: 30.3; 95% CI: 9.6-95.8). Adding GZF5SD mass to MFVA led to reclassification of 39% for SCD and 50.2% for the arrhythmic endpoint. In contrast, LVEF did not predict either endpoint. CONCLUSIONS: In CIED recipients, MFVA excluded patients at risk of SCD and virtually excluded ventricular arrhythmias. Quantified GZF5SD mass added predictive value in relation to SCD and the arrhythmic endpoint.
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Terapia de Resincronización Cardíaca/mortalidad , Muerte Súbita Cardíaca/patología , Desfibriladores Implantables , Miocardio/patología , Fibrilación Ventricular/mortalidad , Fibrilación Ventricular/terapia , Anciano , Anciano de 80 o más Años , Terapia de Resincronización Cardíaca/tendencias , Muerte Súbita Cardíaca/epidemiología , Muerte Súbita Cardíaca/prevención & control , Desfibriladores Implantables/tendencias , Femenino , Fibrosis , Estudios de Seguimiento , Humanos , Imagen por Resonancia Cinemagnética/mortalidad , Imagen por Resonancia Cinemagnética/tendencias , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Fibrilación Ventricular/diagnóstico por imagenRESUMEN
AIMS: The CardioMEMS HF System Post-Market Study (COAST) was designed to evaluate the safety, effectiveness, and feasibility of haemodynamic-guided heart failure (HF) management using a small sensor implanted in the pulmonary artery of New York Heart Association (NYHA) Class III HF patients in the UK, Europe, and Australia. METHODS AND RESULTS: COAST is a prospective, international, multicentre, open-label clinical study (NCT02954341). The primary clinical endpoint compares annualized HF hospitalization rates after 1 year of haemodynamic-guided management vs. the year prior to sensor implantation in patients with NYHA Class III symptoms and a previous HF hospitalization. The primary safety endpoints assess freedom from device/system-related complications and pressure sensor failure after 2 years. Results from the first 100 patients implanted at 14 out of the 15 participating centres in the UK are reported here. At baseline, all patients were in NYHA Class III, 70% were male, mean age was 69 ± 12 years, and 39% had an aetiology of ischaemic cardiomyopathy. The annualized HF hospitalization rate after 12 months was 82% lower [95% confidence interval 72-88%] than the previous 12 months (0.27 vs. 1.52 events/patient-year, respectively, P < 0.0001). Freedom from device/system-related complications and pressure sensor failure at 2 years was 100% and 99%, respectively. CONCLUSIONS: Remote haemodynamic-guided HF management, using frequent assessment of pulmonary artery pressures, was successfully implemented at 14 specialist centres in the UK. Haemodynamic-guided HF management was safe and significantly reduced hospitalization in a group of high-risk patients. These results support implementation of this innovative remote management strategy to improve outcome for patients with symptomatic HF. Clinical registration number: ClinicalTrials.gov identifier: NCT02954341.
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Insuficiencia Cardíaca , Medicina Estatal , Anciano , Anciano de 80 o más Años , Monitoreo Ambulatorio de la Presión Arterial/métodos , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Reino Unido/epidemiologíaRESUMEN
BACKGROUND: The "crescent sign" is a hyperattenuating crescent-shaped region on CT within the mural thrombus or wall of an aortic aneurysm. Although it has previously been associated with aneurysm instability or impending rupture, the literature is largely based on retrospective analyses of urgently repaired aneurysms. We strove to more rigorously assess the association between an isolated "crescent sign" and risk of impending aortic rupture. METHODS: Patients were identified by querying a single health system PACS database for radiology reports noting a crescent sign. Adult patients with a CT demonstrating a descending thoracic, thoracoabdominal, or abdominal aortic aneurysm and "crescent sign" between 2004 and 2019 were included, with exclusion of those showing definitive signs of aortic rupture on imaging. RESULTS: A total of 82 patients were identified. Aneurysm size was 7.1 ± 2.0 cm. Thirty patients had emergent or urgent repairs during their index admission (37%), 19 had elective repairs at a later date (23%), and 33 patients had no intervention due to either patient choice or prohibitive medical comorbidities (40%). Patients without intervention had a median follow up of 275 days before death or loss to follow up. In patients undergoing elective intervention, 6,968 patient-days elapsed between presentation and repair, with zero episodes of acute rupture (median 105 days). Patients undergoing elective repair had smaller aneurysms compared to those who underwent emergent/urgent repair (6.2 ± 1.3 vs. 7.7 ± 2.1 cm, P = 0.008). No surgical candidate with an aneurysm smaller than 8 cm ruptured. There were 31 patients with previous axial imaging within 2 years prior to presentation with a "crescent sign," with mean aneurysm growth rate of 0.85 ± 0.62 cm per 6 months [median 0.65, range 0-2.6]. Those with aneurysms sized below 5.5 cm displayed decreased aneurysm growth compared to patients with aneurysm's sized 5.5-6.5 cm or patients with aneurysms greater than 6.5 cm (0.12 vs. 0.64 vs. 1.16 cm per 6 months, P= 0.002). CONCLUSIONS: The finding of an isolated radiographic "crescent sign" without other signs of definitive aortic rupture (i.e., hemothorax, aortic wall disruption, retroperitoneal bleeding) is not necessarily an indicator of impending aortic rupture, but may be found in the setting of rapid aneurysm growth. Many factors, including other associated radiographic findings, aneurysm size and growth rate, and patient symptomatology, should guide aneurysm management in these patients. We found that patients with minimal symptoms, aneurysm sizes below 6.5 cm, and no further imaging findings of aneurysm instability, such as periaortic fat stranding, can be successfully managed with elective intervention after optimization of comorbid factors with no evidence of adverse outcomes.