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Qualitative interviews results from heart failure survey respondents on the interaction between symptoms and burden of self-care work.

AIMS AND OBJECTIVES: Following a cross-sectional survey, a sub-sample of participants was interviewed to explore the interaction between symptoms and burden of treatment. BACKGROUND: Burden of treatment considers both the work associated with illness and treatment, including self-care work, as well as the individuals' capabilities and resources to engage in that work. The recent survey revealed the existence of a complex interaction. DESIGN: Qualitative abductive analysis of semi-structured interviews. METHODS: Adults with heart failure who participated in the survey were purposely sampled and invited to participate in semi-structured interviews. Location and mode of interview varied by participant choice. Excerpts from the verbatim transcripts were assessed for interactions between symptoms and burden of treatment, and when identified these were characterised and explained. We followed COREQ checklist for reporting. The patient research ambassador group was involved from research design to dissemination. RESULTS: Participants (n = 32) consistently discussed how symptoms altered their capability to engage in self-care work. As symptom intensity increased the difficultly of their self-care work increased. A number of intervening factors appeared to influence the relationship between symptoms and burden of treatment. Intervening factors included illness pathology, illness identity, the value of the tasks attempted and available support structures. These factors may change how symptoms and burden of treatment are perceived; a model was constructed to explain and summarise these interactions. CONCLUSIONS: The interaction between symptoms and burden of treatment is complex. Intervening factors-illness identity and pathology, task value and performance, and available support structures-appear to exert a strong influence on the interaction between symptoms and burden of treatment. RELEVANCE TO CLINICAL PRACTICE: These intervening factors present clinicians and researchers with opportunities to develop interventions that might reduce burden of treatment and improve symptoms and quality of life. CLINICAL TRIAL REGISTRATION: SYMPACT was registered with ISRCTN registry: ISRCTN11011943

Do chronic heart failure symptoms interact with burden of treatment? Qualitative literature systematic review.

OBJECTIVE: Explore the interaction between patient experienced symptoms and burden of treatment (BoT) theory in chronic heart failure (CHF). BoT explains how dynamic patient workload (self-care) and their capacity (elements influencing capability), impacts on patients' experience of illness. DESIGN: Review of qualitative research studies. DATA SOURCES: CINAHL, EMBASE, MEDLINE, PsycINFO, Scopus and Web of Science were searched between January 2007 and 2020. ELIGIBILITY CRITERIA: Journal articles in English, reporting qualitative studies on lived experience of CHF. RESULTS: 35 articles identified related to the lived experience of 720 patients with CHF. Symptoms with physical and emotional characteristics were identified with breathlessness, weakness, despair and anxiety most prevalent. Identifying symptoms' interaction with BoT framework identified three themes: (1) Symptoms appear to infrequently drive patients to engage in self-care (9.2% of codes), (2) symptoms appear to impede (70.5% of codes) and (3) symptoms form barriers to self-care engagement (20.3% of codes). Symptoms increase illness workload, making completing tasks more difficult; simultaneously, symptoms alter a patient's capacity, through a reduction in their individual capabilities and willingness to access external resources (ie, hospitals) often with devasting impact on patients' lives. CONCLUSIONS: Symptoms appear to be integral in the patient experience of CHF and BoT, predominately acting to impede patients' efforts to engage in self-care. Symptoms alter illness workload, increasing complexity and hardship. Patients' capacity is reduced by symptoms, in what they can do and their willingness to ask for help. Symptoms can lower their perceived self-value and roles within society. Symptoms appear to erode a patient's agency, decreasing self-value and generalised physical deconditioning leading to affective paralysis towards self-care regimens. Together describing a state of overwhelming BoT which is thought to be a contributor to poor engagement in self-care and may provide new insights into the perceived poor adherence to self-care in the CHF population. PROSPERO REGISTRATION NUMBER: CRD42017077487

SYMptoms in chronic heart failure imPACT on burden of treatment (SYMPACT): a cross‐sectional survey

Aims: This study aimed to describe patient‐reported symptoms and burden of treatment (BoT) experienced by patients with chronic heart failure (CHF). BoT describes the illness workload, individual capacity to perform that work, and resultant impact on the individual. Overwhelming BoT is related to poor quality of life and worse clinical outcomes. This research is the first to explore symptoms and BoT in people with CHF, in the UK. Methods and results: This is a cross‐sectional questionnaire survey of CHF patients. Participants completed the Heart Failure Symptom Survey (HFSS; max score 10) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ; max scores: physical 40, emotional 25, and total 105), which measured symptoms. BoT was measured with the Patient Experience with Treatment and Self‐management (PETS; max score 100) questionnaires. Participant characteristics and questionnaire results were summarized using descriptive statistics. Relationships between symptoms and BoT, summarized by the workload and impact indices, were explored using Spearman's and Pearson's correlation coefficients together with scatter plots. The survey was completed by 333 participants, mean age of 71 (±13) years old. The majority (89%) were recruited from secondary care NHS trusts, and 25% were female. All types of heart failure were represented. Mean symptom scores were as follows: HFSS burden score: 2.4 (±2.1), and MLHFQ scores: physical score 20 (±12.4), emotional score 9.9 (±8.1), and total score 41.3 (±26.3). The highest mean PETS domain scores were exercise [51.3 (±24.7)], diet [40.3 (±22.7)], difficulty with healthcare services [39.9 (±21.3)], and physical and mental fatigue [36.0 (±25.7)]. Pairwise correlations were observed between HFSS scores and MLHFQ physical and emotional sub‐scores with PETS workload and impact indices. Positive correlations were weak to moderate (0.326–0.487) between workload index and symptoms, and moderate to strong between impact index and symptoms (0.553–0.725). The P value was 0.006, adjusted by Bonferroni's correction. Conclusions: Symptoms are associated with BoT in CHF patients. Although symptom burden was low, CHF patients reported higher levels of burden around self‐care activities of exercise, diet, healthcare interaction, as well as physical and mental fatigue due to engagement with self‐care regimens. Observed higher levels of burden were in key self‐care areas for CHF and suggest areas where service delivery and support of CHF patients may be improved to reduce BoT. Clinicians could individualize their consultations by focusing on troublesome symptoms, as well as alleviating illness workload, which may better enable patients to live well with CHF

Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN):an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial

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.</p

Intravenous iron for heart failure with evidence of iron deficiency: a meta-analysis of randomised trials

Background: The recent AFFIRM-AHF trial assessing the effect of intravenous (IV) iron on outcomes in patients hospitalised with worsening heart failure who had iron deficiency (ID) narrowly missed its primary efficacy endpoint of recurrent hospitalisations for heart failure (HHF) or cardiovascular (CV) death. We conducted a meta-analysis to determine whether these results were consistent with previous trials. Methods: We searched for randomised trials of patients with heart failure investigating the effect of IV iron vs placebo/control groups that reported HHF and CV mortality from 1st January 2000 to 5th December 2020. Seven trials were identified and included in this analysis. A fixed effect model was applied to assess the effects of IV iron on the composite of first HHF or CV mortality and individual components of these. Results: Altogether, 2,166 patients were included (n = 1168 assigned to IV iron; n = 998 assigned to control). IV iron reduced the composite of HHF or CV mortality substantially [OR 0.73; (95% confidence interval 0.59–0.90); p = 0.003]. Outcomes were consistent for the pooled trials prior to AFFIRM-AHF. Whereas first HHF were reduced substantially [OR 0.67; (0.54–0.85); p = 0.0007], the effect on CV mortality was uncertain but appeared smaller [OR 0.89; (0.66–1.21); p = 0.47]. Conclusion: Administration of IV iron to patients with heart failure and ID reduces the risk of the composite outcome of first heart failure hospitalisation or cardiovascular mortality, but this outcome may be driven predominantly by an effect on HHF. At least three more substantial trials of intravenous iron are underway

Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN):an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial

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.</p

Intravenous iron for heart failure, iron deficiency definitions, and clinical response:the IRONMAN trial

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 &lt; 100 µg/L or transferrin saturation (TSAT) &lt; 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 &lt; .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 &lt; 20%, especially when ferritin was ≥100 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 &lt; 20% with ferritin &gt; 100 µg/L might identify patients with heart failure who obtain greater benefit from intravenous iron. This interpretation requires confirmation.</p

Intravenous iron for heart failure, iron deficiency definitions, and clinical response:the IRONMAN trial

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 &lt; 100 µg/L or transferrin saturation (TSAT) &lt; 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 &lt; .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 &lt; 20%, especially when ferritin was ≥100 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 &lt; 20% with ferritin &gt; 100 µg/L might identify patients with heart failure who obtain greater benefit from intravenous iron. This interpretation requires confirmation.</p

Change in renal function associated with drug treatment in heart failure: national guidance.

Inhibitors of the renin-angiotensin-aldosterone (RAAS) system are cornerstones of the management of patients with heart failure with reduced left ventricular ejection fraction (HFrEF). However, RAAS inhibitors may cause decline in renal function and/or hyperkalaemia, particularly during initiation and titration, intercurrent illness and during worsening of heart failure. There is very little evidence from clinical trials to guide the management of renal dysfunction. The Renal Association and British Society for Heart Failure have collaborated to describe the interactions between heart failure, RAAS inhibitors and renal dysfunction and give clear guidance on the use of RAAS inhibitors in patients with HFrEF. During initiation and titration of RAAS inhibitors, testing renal function is mandatory; a decline in renal function of 30% or more can be acceptable. During intercurrent illness, there is no evidence that stopping RAAS inhibitor is beneficial, but if potassium rises above 6.0 mmol/L, or creatinine rises more than 30%, RAAS inhibitors should be temporarily withheld. In patients with fluid retention, high doses of diuretic are needed and a decline in renal function is not an indication to reduce diuretic dose: if the patient remains congested, more diuretics are required. If a patient is hypovolaemic, diuretics should be stopped or withheld temporarily. Towards end of life, consider stopping RAAS inhibitors. RAAS inhibition has no known prognostic benefit in heart failure with preserved ejection fraction. Efforts should be made to initiate, titrate and maintain patients with HFrEF on RAAS inhibitor treatment, whether during intercurrent illness or worsening heart failure