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Aims Remote monitoring of patients with physiological data derived from cardiac implanted electronic devices (CIEDs) offers potential to reconfigure clinical services. The ‘Heart Failure Risk Score' (HFRS) uses input from integrated device physiological monitoring to risk‐stratify patients as low‐risk, medium‐risk, or high‐risk of a heart failure event in the next 30 days. This study aimed to evaluate a novel clinical pathway utilizing a combination of CIED risk‐stratification and telephone triage to identify patients with worsening heart failure (WHF). Methods and results A prospective, single‐centre, real‐world evaluation of the ‘Triage‐HF Plus' clinical pathway (HFRS in combination with telephone triage) over a 27 month period. One hundred and fifty‐seven high‐risk HFRS transmissions were referred for telephone triage assessment. Interventions were at the discretion of the clinical assessor acting in accordance with clinical guidelines. An additional 3month consecutive sample of low and medium HFRS transmissions (control group) were also contacted for telephone triage assessment (n = 98). Successful telephone contact was made in 127 (81%) of referred high‐risk HFRS cases: 71 (55.9%) were confirmed to have WHF requiring intervention; 19 (14.9%) had an alternative acute medical problem; one patient had been recently discharged from hospital with WHF; and 36 (28.0%) had no apparent cause for the high score. In the control group, only one patient had symptoms of WHF. The sensitivity and specificity of CIED‐based remote monitoring to identify WHF 98.6% (92.5–100.0%) and 63.4% (55.2–71.0%), respectively. Conclusions The Triage‐HF Plus clinical pathway is a potentially useful remote monitoring tool for patients with heart failure and in situ CIEDs.

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. 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. 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). 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. British Heart Foundation and Pharmacosmos.

IntroductionHospitalisation for worsening heart failure (WHF) is a huge burden on UK healthcare resources. There is a growing trend to managing WHF at home or in daycare facilities (9.7% in our 2022 survey)1 to reduce hospitalization burden. This risks compromising patient care and outcomes, although a UK pilot trial provides some reassurance that this is not the case.2 However, further evidence of longer-term safety is required.MethodsNinety-three patients with WHF for which they received IV diuretics were followed for up to 5 years, of whom 33 had been managed without admission and 60 had been hospitalised. Baseline characteristics including demographics, New York Heart Association (NYHA), renal function, echocardiographic findings were documented. All-cause hospitalisation and mortality at 60 days, 1 year and all follow-up were recorded The primary outcome was all-cause mortality.SPSS Version 28 was used to perform statistical analysis. Mean (SD) or Median [interquartile range] was used to describe continuous variables depending on whether normally distributed or not; and frequency for categorical variables. Kaplan Meir curves were plotted for time to readmission or death.ResultsBy 60 days, a higher mortality was observed in those managed without admission (24 % vs 12%), a difference that persisted at 1 year (52% vs 17%) and for the duration of follow-up (79% vs 25%; log rank P-value = 0.001). [See figure 1]. Hospitalisations were also higher (85% vs 47%, log rank P-value <0.001).Baseline characteristics of patients managed without or with hospital admission were summarised in the (table 1). They have similar age (77 vs 76 years), proportion of women (33% v 45%), proportion in NYHA functional class III or worse (79% and 80%) and with HFrEF (58% vs 65%), at least moderately impaired left ventricular systolic function (39% and 55%), but patients treated without admission had worse renal function (eGFR- 41 [28,54] vs. 59 [34,79], p=0.008).Although it is possible renal function is a confounding variable contributing to excess readmissions and deaths, this study demonstrates the need for meticulous follow-up.ConclusionManagement of WHF at home or in day-care facilities is associated with high rates of admission and death when compared with standard inpatient care. A large multicentre randomised trial is needed to determine the safety and effectiveness of managing patients with WHF at home or in day-care facilities. In the meantime, we urge caution for sites developing such services. Careful and responsive follow-up and audit are essential.ReferencesAbdullah A, et al. Outpatient-based acute HF care calls for development of clinical psychology service for whole-person care provision. Br J Cardiol 2022;29:141–4.K Wong et al Effectiveness of out-patient based acute heart failure care: a pilot randomised controlled trial. Acta Cardiol. 2023;78:828–837.Abstract 5-023 Table 1Baseline characteristics and heart failure treatment outcomes in outpatient and inpatient settings Outpatient (N=33) Inpatient (N=60) p Age (years) 77 [69,85] 76 [68, 82] 0.6 Gender[number of females (%)] 11(33%) 27 (45%) 0.4 LVSD Preserved Mild Moderate Severe 14 (42%)6 (18%)4 (12%)9 (27%) 21 (35%)6 (10%)11(18%)22 (37%) HFpEF vs HFrEFP=0.5Preserved or mild vsModerate to severeP=0.2 EGFR at admissionMean (SD) 43 (21) 57 (24) 0.008* NYHA I II III IV 07 (21%)19 (58%)7 (21%) 6(10%)6 (10%)20 (33%)28 (47%) NYHA 1 or 2 vs 3 or 4(p=1) All cause mortality 60 days 1 year 8 (24%)17 (52%) 7(12%)10 (17%) Mortality rate (by censor date) 26 (79%) 15 (25%) 0.001 Hospitalisation/readmissionRate (by censor date) 28(85%) 28 (47%) <0.001 Abstract 5-023 Figure 1Home/Day-care based IV diuretic therapy is associated with a higher mortality (log rank p=0.001)[Figure omitted. See PDF]

BackgroundIn health, women have a lower haemoglobin than men and their prevalence of both anaemia and iron deficiency may be higher, especially if they have heart failure. The erythropoietic response to iron might also differ between the sexes. We used data from a randomised trial (IRONMAN) of intravenous (IV) ferric derisomaltose (FDI) to investigate these issues.MethodsPatients with a diagnosis of heart failure, a left ventricular ejection fraction ≤45%, and either a TSAT <20% or serum ferritin <100 µg/L were included. Haemoglobin for women had to be in the range of 9-13 g/dL and for men 9-14g/dL. Patients were randomised to receive IV ferric derisomaltose (FDI) or not. Neither the patient nor investigator was blinded. The main endpoints of interest were changes in haemoglobin at 4 months and 12 months and the primary endpoint of the trial (the rate of the composite outcome of heart failure hospitalisations or cardiovascular death expressed as events per 100 patient-years). Analyses were conducted by intention to treat, stratified by sex. A further analysis was conducted for patients with a TSAT <20%.ResultsOf 1,137 patients randomised, 300 were women. Women and men were of similar age (73 vs 74 years), predominantly in NYHA class II, with similar values for NT-proBNP, LVEF, eGFR, ferritin and TSAT. However, haemoglobin was lower in women (11.8 [11.0 to 12.4] g/dL] compared to men (12.3 [11.3 to 13.0] g/dL).The increases in haemoglobin with FDI compared to control was similar for women at 4 months (+0.8 [+0.5 to +1.2] g/dL) and 12 months (+0.8 [+0.4 to +1.3] g/dL) compared to men ((+0.5 [+0.3 to +0.7] g/dL) and (+0.5 [+0.3 to +0.8] g/dL) respectively.The hazard ratio for the primary endpoint for men was 0.81 (0.63 to 1.03) and for women 0.77 (0.42 to 1.42), the wider confidence intervals reflecting the smaller population and fewer events. The results were similar when restricted to patients with a TSAT <20%.ConclusionsThe increase in haemoglobin with IV FDI and its effect on the primary endpoint rate are similar for men and women.Abstract 144 Table 1Prevalence of iron deficiency and response to IV iron according to sex in a randomised trial of intravenous iron (IRONMAN)malefemale Baseline N= 837300 Age74 (67,80)72 (65,78) NYHA II (%)479 (57)169 (56) CAD NT-proBNP1785(936,3788)N=4231414(780,2659)N=142 BNP414 (212,715)N=152285 (188,598)N=45 TSAT 16 (11,20)15 (10,19) Ferritin52 (31,87)42 (27,79) LVEF33 (25, 37)35 (27,39) eGFR51 (38,69)51 (39,68) Haemoglobin Baseline12.3(11.3,13.0)11.8(11.0,12.4) Follow-up UCFDIDiff/RRUCFDIDiff/RR Haemoglobin month 412.4(1.5)12.9(1.4)0.5(0.3,0.7)11.7(1.1)12.6(1.3)0.9(0.6,1.2) Haemoglobin month 1212.6 (1.7)13.1 (1.4)0.6 (0.3,0.8)11.7(1.1)12.4 (1.4)0.7(0.3,1.1) Delta haemoglobin month 40.2 (1.3)0.8(1.3)0.5(0.3,0.7)0.1(1.0)0.9(1.5)0.8(0.5,1.2) Delta haemoglobin month 120.3 (1.6)0.9 (1.4)0.5 (0.3,0.8)-0.0 (1.2)0.8 (1.5)0.8 (0.4,1.3) Primary Endpoint recurrent events, rate (per 100 patient years) and rate ratio. All314 (29.8)257 (23.5)0.81 (0.63,1.03)148 (21.3)129 (17.4)0.77 (0.42,1.42) TSAT <20% TSAT <20% onlymalefemale Baseline N= 629238Age74 (67,79)73 (65,78)NYHA II (%)336 (53)129 (54)CADNT-proBNP1986(1001,4241)N=2941492(802,2954)N=107BNP440 (220,726)N=121302(194,608) n-36TSAT 13(9,17)13(9,16)Ferritin51 (29,104)39 (24,81)LVEF31 (25,36)35(27,39)eGFR51(37,68)51(39,68)Haemoglobin Baseline12.1(11.1,12.9)11.7(10.8,12.3) Follow-up UCFDIDiff/RRUCFDIDiff/RRHaemoglobin month 412.3(1.5)12.9(1.5)0.6 (0.3,0.9)11.7(1.1)12.7(1.4)0.9(0.6,1.3)Haemoglobin month 1212.6 (1.8)13.1(1.4)0.6(0.2,0.9)11.7(1.2)12.4(1.5)0.7(0.3,1.2)Delta haemoglobin month 40.3(1.3)1.0(1.4)0.7(0.4,0.9)0.2(1.0)1.2(1.6)1.0(0.6,1.4)Delta haemoglobin month 120.5(1.8)1.1(1.4)0.6(0.2,0.9)0.1(1.2)1.0(1.6)1.0(0.5,1.5)Primary Endpoint recurrent events, rate (per 100 patient years) and rate ratio.240(32.6)191(24.1)0.75(0.57,1.00)84(23.1)63(22.5)0.94(0.55,1.63)Conflict of InterestNone

Background/IntroductionEarly detection of worsening congestion in heart failure (HF) patients can prompt timely interventions and potentially decrease hospital admissions. Accordingly, standard care recommendations include the monitoring of symptoms and daily weighing at home. However, most patients with worsening HF do not appear to weigh themselves during the weeks prior to the hospital admission. Up to half of hospital admissions were associated with moderate to severe peripheral oedema and that oedema was strongly associated with subsequent prognosis. This suggests a missed opportunity for clinicians to respond rapidly to early changes in congestion.PurposeA camera-based technology linked to artificial intelligence software for remote home-monitoring of lower-leg volume was developed, that, unlike daily weights, does not require patient adherence. The main aims of our pilot randomised cross-over trial were to determine the feasibility of data-collection and blinding of randomisation and to estimate event rates to inform the design of future trials of the AI device.MethodsSingle-centre, pilot, double-blind, randomised cross-over trial in patients with HF at increased risk of decompensated HF requiring hospital admission. The main outcome measure was the proportion of participants that provided information on each available study day (ie: on the days they were alive and out of hospital over 30 days) of leg volume data, weight. Patients received guideline-recommended care and were asked to report worsening symptoms or weight gain. Patients were randomly assigned to having device monitoring data concealed or disclosed to a physician (as alerts) for two periods of 30 days.ResultsBetween March and June 2021, we enrolled 27 patients (median [IQR] age 75 years [63–78], 41% women, 48% with a left ventricular ejection fraction >50%). For each monitoring period, participants accrued 29 days alive and out of hospital. Only 37% of patients weighed themselves on at least half of days; the median [IQR] number of days with available weights was 8.5 [0–21.5]. Substantially more patients (74%) had lower-leg volume measured on at least half of days; the median [IQR] number of days with available lower-leg volumes was 25 [16–29]. There were 4 hospitalisations from 4 patients in the monitored group (vs 7 hospitalisations from 4 patients in the unmonitored group). There were no deaths in the monitored group (1 patient died in the unmonitored arm).Abstract 116 Figure 1consort diagramAbstract 116 Figure 2Data availability for weights and volumesConclusionThis pilot trial suggests that measurements of leg-volume are more likely to be acquired than weights for patients with HF. Given that weight monitoring is routinely recommended in HF management, this finding represents a potentially significant improvement over standard care.Conflict of InterestThis work was supported by a research grant with funding provided by Heartfelt technology-the company which manufactures the AI device.

BackgroundIntravenous iron therapy with ferric derisomaltose (FDI) has been shown to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, its effects across different age groups remain unclear. This analysis of the Effectiveness of Intravenous Iron Treatment versus Standard Care in Patients with Heart Failure and Iron Deficiency (IRONMAN) trial explored the efficacy and safety of FDI across age groups.MethodsThe IRONMAN trial was a prospective, open-label, blinded end point randomised controlled trial enrolling patients with HFrEF and iron deficiency. This prespecified analysis stratified the population into four quarters by age group: <67 years, 67–73 years, 74–79 years, >79 years. The primary outcome was a composite of recurrent heart failure hospitalisations and cardiovascular death. Secondary outcomes included changes in haemoglobin and quality of life. Clinical outcomes comparing FDI versus usual care in each age subgroup were analysed by the method of Lin et al for recurrent events and Cox proportional hazards model for time to first event. Interactions between age and treatment effects were explored.ResultsAmong 1137 randomised patients (median age 73 years), the primary outcome rate ratio (FDI vs usual care) was 0.87 (95% CI 0.61 to 1.23) in patients <67 years, 0.93 (95% CI 0.66 to 1.32) in those aged 67–73 years, 0.88 (95% CI 0.59 to 1.33) in those aged 74–79 years and 0.66 (95% CI 0.45 to 0.96) in those aged >79 years (p-interaction=0.38). Improvements in haemoglobin and quality of life scores at 4 months did not differ statistically across age groups (p-interaction=0.92 and 0.64, respectively). Older patients were more symptomatic at baseline, with higher N-terminal-pro B-type natriuretic peptide levels and poorer renal function, but safety outcomes did not differ across age groups.ConclusionsWe found no evidence that the effects of FDI on heart failure hospitalisations, cardiovascular death, haemoglobin and quality of life differed by age. These findings support its use in patients with HFrEF and iron deficiency, including older adults.Trial registration number NCT02642562.

IntroductionHeart Failure mortality is high -7% if patients are under the care of Cardiologists, or 11% if under general physicians (according to the national heart failure audit in 2013). It is unclear whether cardiologists are ‘cherry-picking’ patients who are less frail with fewer co-morbidities.Hypothesis and AimCardiologists select patients who are less frail with fewer co-morbidities. We also aimed to compare the compliance to NICE quality standard and length of stay between patients admitted to general medical wards, cardiology ward in the Lancashire Cardiac Centre, and an Acute Cardiac Ward (ACW)-‘Ward 19’, led by Consultant Cardiologists, supported by a team of Cardiology juniors and nurses, adjacent to our Acute Medical Unit (AMU) in the District General Hospital (DGH) part of the Trust.MethodologyThe study was carried out in Blackpool Victoria Hospital. The data was collected from 99 patients admitted to Blackpool Victoria Hospital. Data was collected retrospectively (random sample from 2016-8).ResultsThere is no significant difference in Derby Frailty Index between patients admitted to DGH wards, the ACW and Tertiary Cardiac Centre wards. The Rockwood frailty score was slightly higher in the DGH wards compared with the ACW, but not significantly different with the tertiary centre wards. More co-morbidities were observed in patients in the DGH wards compared with the ACW but not significantly different compared with the tertiary centre. However, there is no significant difference in the age of patients, or proportion of patient on palliative care. Importantly, the proportion of people who suffered ‘falls’/ reduced mobility was not significantly different between the groups. Thus, our observation that more patients in Cardiology/ACW were receiving MRA could not be explained by lower blood pressure for instance.LimitationsThere is significant difference in terms of heart failure treatment received in patients admitted under general medicine vs cardiology. However, tendency to falls in 1/3 of DGH patients may be a clinically important reason that may contribute to lower use of MRA in DGH (even though the small study has not found a statistically significant difference in % of patients who suffer falls). Notably, 13% DGH patients were discharged without echocardiography.Tendency for DGH wards to have higher frailty score, also multiple markers of frailty–incontinence, confusion, falls/reduced mobility (though not statistically significant) does suggest the cohort is more frail. Equally, they are probably appropriately placed for the MDT delivery of comprehensive geriatric assessment. The key is to ensure they receive cardiology/HF specialist input.Abstract 97 Table 1Abstract 97 Table 2ConclusionWe have found no definitive evidence to suggest Cardiologists are cherry-picking patients, in terms of age, creatinine, Derby Frailty index, falls, reduced mobility and palliative care. Patients in the ACW were slightly less frail (Rockwood score) with fewer comorbidities, but the proportion of patients who fall and BP is similar to DGH patients. Despite that, more Cardiology patients are on appropriate HF medication than DGH patients. More research is required to test whether it is possible to safely reduce the length of stay in patients in Cardiac wards and whether frail heart failure patients may cope with outpatient based therapy for acute decompensation.Conflict of InterestNo conflict of interest

IntroductionIn England and Wales, heart failure (HF) was the primary diagnosis for >81,000 hospital admissions in 2016-17, with a 30-day readmission rate of nearly 20%. The National HF Audit reports that half of these admissions were associated with moderate or severe peripheral oedema. Conventionally, leg oedema is assessed and graded by a healthcare professional (HCP). A serial measurement of weight is an alternative method of assessing water retention at home but this relies on patient compliance.The Heartfelt device uses high-resolution cameras to generate 3D images of the lower legs and calculates volumes with a precision of about 20mLs without the need for active patient input. Linking Artificial Intelligence algorithms may then be applied to inform either the patient or a healthcare professional of appropriate actions.MethodsThe Lancashire Objective Volume Evaluation of leg oedema in Heart Failure (LOVE-HF) artificial intelligence research programme consists of two pilot randomised controlled, cross-over trials (each with 30 patients and 30 day assessment periods), a registry and screening log (the latter to permit comparison of baseline characteristics to ensure generalisability).Patients with HF who received IV diuretics (within <6 months) or with peripheral oedema despite receiving at least 80 mg/day of oral furosemide (or equivalent), will be enrolled in LOVE-HF (comparing the Heartfelt device on top of standard care to standard care: figure 1) and LOVE-HF-2 (comparing the Heartfelt device to weight monitoring: figure 2). The efficacy outcome of interest is ‘number of days alive out of hospital’. Secondary outcomes include serious adverse events, quality of life, mental wellbeing, hopelessness scores and HF-symptoms.Abstract 134 Figure 1Abstract 134 Figure 2These vanguard trials will determine the feasibility of data-collection and confirm estimates of event rates that will inform the design of a substantial multi-centre trial (GLOVE-HF- GLobal Objective Volume Evaluation of oedema in Heart Failure) to determine the clinical utility of the Heartfelt device.Conflict of InterestHeart Failure

IntroductionAcute heart failure (AHF) hospitalisation is typically lengthy, costly and associated with 10% mortality. Outpatient based management (OPM) of AHF appeared effective in observational studies. We conducted a pilot randomised controlled trial (RCT) comparing OPM with standard inpatient care (IPM). Hopelessness independently predicted mortality in patients with risk factors of ischaemic heart disease. We hypothesize that patients randomised to OPM may be more hopeful and have better mental well-being, with better quality of life, patient and carer satisfaction.MethodsWe randomised patients with AHF, considered to need IV diuretic treatment for >2 days, to IPM or OPM. We recorded all-cause mortality (index-episode), and the number of full days alive and out-of-hospital (DAOH) within 60 days after randomisation. Quality of life (EQ5D-VAS), mental well-being [Short Warwick-Edinburgh Mental Wellbeing scale] and hope (Adult State Hope Scale) scores which have been validated as accurate in detecting fluctuations in hope were assessed up to 60 days follow-up. We calculated mean NHS cost savings and 95% central range (CR) from bootstrap analysis.ResultsEleven patients were randomised to IPM and thirteen to OPM. There was no statistically significant difference in all-cause mortality during the index episode (1/11 vs 0/13) and up to 60 days follow-up (2/11 vs 2/13) [log rank p=0.86]. (Figure 1). Patients randomised to IPM accrued a median of 47 [IQR 36, 51] vs 59 [41, 60] DAOH in OPM (p=0.13). 2 patients randomised to IPM (vs 6 OPM) were readmitted within 60 days [p=0.31]. Hope scores increased more with OPM within 30 days after randomisation but by 60 days, dropped to lower levels compared with the group allocated to IPM (not statistically significant). (Table 1). In-patients’ mental well-being score was higher at baseline but more out-patients had increased total well-being scores by the 60-day follow-up visit (p=0.04). (Table 2). 100% patients in both arms were satisfied according to the ‘NHS Family and Friends Test’ but interestingly 100% would choose OPM again whilst only 90% would choose Inpatient care again. Similarly, 100% carers were satisfied in the OPM arm whilst 60% only were satisfied if the patient was randomised to inpatient care. 100% carers would choose OPM again, vs 60% IPM carers.OPM was associated with mean cost savings of £2,658 (95% CR 460 - 4,857) per patient during the index episode.Abstract 152 Figure 1ConclusionsPatients with acute HF randomised to OPM accrued more DAOH (albeit not statistically significant in this small pilot RCT). There was no increase in mortality but there was a higher risk of readmissions (not statistically significant). OPM was associated with improved mental well-being. But the initial increase in hope diminished within 60 days, possibly as a result of increased readmissions. The pilot RCT generated important hypotheses that need further testing in a large multicentre RCT.Conflict of Interestnone