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In a randomized trial involving patients with a low LVEF and viable myocardium who received optimal medical therapy, PCI did not lead to a lower incidence of death or hospitalization for heart failure.

Informal carers (i.e., family members or friends) of patients with heart failure are ill-prepared and under-supported for their caregiving role. To address this issue, the HEart faiLure carer support Programme was co-designed with carers and healthcare professionals, with pilot testing demonstrating intervention feasibility and acceptability. In the current article, we present the study protocol for evaluating the implementation and impact of the HEart faiLure carer support Programme in real-world, clinical settings across the United Kingdom (ClinicalTrials.gov ID: NCT07373041). A mixed-method, implementation study adopting a multi-centre, prospective cohort study design, with nested process and economic evaluations will be conducted. Nurses will deliver the HEart faiLure carer support Programme to 180 carers of patients with symptomatic heart failure across five sites spanning three nations of the United Kingdom (Northern Ireland, England, and Scotland). The patients (approximately 180) of carers enrolled in the project will be invited to provide outcome data. Recruited carers will receive weekly, nurse-led, online support group sessions and supplementary, self-directed educational resources (a booklet and website) for six weeks. Quantitative (i.e., questionnaires and logs) and qualitative (i.e., interviews) data will be collected from carers, patients, and healthcare professionals throughout the study. These data will evaluate the acceptability, fidelity, context, economic cost, and impact of HEart faiLure carer support Programme delivery in real-world clinical settings. An integrative analysis with mapping to the Consolidated Framework for Implementation Research and Normalisation Process Theory domains will be conducted, which will identify key synergies across quantitative and qualitative data sets. The results will elucidate the factors underpinning successful intervention translation to clinical practice and identify any required contextual adaptations, along with generating preliminary evidence of intervention impact. These findings will inform a large-scale, type 2 hybrid study, advancing the HEart faiLure carer support Programme towards routine rollout across the United Kingdom.

Introduction Several landmark randomized‐controlled trials (RCTs) have demonstrated the efficacy of sodium‐glucose co‐transport 2 (SGLT2) inhibitors in reducing all‐cause mortality, cardiovascular (CV) mortality and heart failure (HF) hospitalizations. Much interest surrounds their mechanism of action and whether they have direct effects on reverse cardiac remodelling. Therefore, we conducted a meta‐analysis of placebo controlled RCTs evaluating the impact of SGLT2 inhibition on imaging derived markers of reverse cardiac remodelling in patients with HF. Methods We performed a systematic review and meta‐analysis in accordance with the Preferred Reporting Items for Systematic Review and Meta‐Analysis (PRISMA) Statement and Cochrane Collaboration. Data interrogation of each major database including PubMed, EMBASE, MEDLINE and Cochrane Library was performed. RCTs evaluating HF patients >18 years comparing SGLT2 inhibitor versus placebo‐control were included. Outcome measures included left ventricular end‐diastolic volume and volume index (LVEDV/LVEDVi), left ventricular end‐systolic volume and volume index (LVSDV/LVSDVi), left ventricular ejection fraction (LVEF), left ventricular mass index (LVMi), left atrial volume index (LAVi) and left ventricular global longitudinal strain (LV GLS). Studies with an HF with preserved ejection fraction population were excluded from analysis of parameters, which would be significantly affected by baseline LVEF, such as volumes and LVEF. The mean difference and standard error were extracted from each study and a random effects model used pool the mean difference and standard error across studies. A pre‐specified sub‐group analysis was performed to stratify results according to imaging modality used (cardiac magnetic resonance imaging and echocardiography). This study is registered on PROSPERO: CRD42023482722. Results Seven randomized, placebo‐controlled trials in patients with HF comprising a total population of 657 patients were included. Overall LVEF of included studies ranged from 29 ± 8.0% to 55.5 ± 4.2%. In studies included in analysis of HFrEF parameters, baseline LVEF ranged from 29 ± 8% to 45.5 ± 12%. Pooled data demonstrated SGLT2 inhibition, compared with placebo control, resulted in significant improvements in mean difference of LVEDV [−11.62 ml (95% confidence interval, CI −17.90 to −5.25; z = 3.67, P = 0.0004)], LVEDVi [−6.08 ml (95% CI −9.96 to −2.20; z = 3.07; P = 0.002)], LVESV [−12.47 ml (95% CI −19.12 to −5.82; z = 3.68; P = 0.0002)], LVESVi [−6.02 ml (95% CI −10.34 to −1.70; z = 2.73; P = 0.006)], LVM [−9.77 g (95% CI −17.65 to −1.89; z = 2.43; P = 0.02)], LVMi (−3.52 g [95% CI −7.04 to 0.01; z = 1.96; P = 0.05)] and LVEF [+2.54 mL (95% CI 1.10 to 3.98; z = 3.62; P = 0.0005)]. No significant difference in GLS (n = 327) [+0.42% (95%CI −0.19 to 1.02; P = 0.18)] or LAVi [−3.25 ml (95% CI −8.20 to 1.69; z = 1.29; P = 0.20)] was noted. Conclusion This meta‐analysis provides additional data and insight into the effects of SGLT2 inhibition on reverse cardiac remodelling in patients with HF. Compared with placebo control, we found that treatment with a SGLT2 inhibitor produced significant improvements in several markers of reverse cardiac remodelling.

Background In Europe, more than 15 million people live with heart failure (HF). It imposes an enormous social, organizational and economic burden. As a reaction to impending impact on healthcare provision, different country-specific structures for HF-care have been established. The aim of this report is to provide an overview and compare the HF-care approaches of Germany, Ireland, the Netherlands and the UK, and to open the possibility of learning from each other’s experience. Methods A mixed methods approach was implemented that included a literature analysis, interviews and questionnaires with HF-patients and caregivers, and expert interviews with representatives from healthcare, health service research and medical informatics. Results The models of HF-care in all countries analyzed are based on the European Society of Cardiology guidelines for diagnosis and treatment of HF. Even though the HF-models differed in design and implementation in practice, key challenges were similar: (i) unequal distribution of care between urban and rural areas, (ii) long waiting times, (iii) unequal access to and provision of healthcare services, (iv) information and communication gaps and (v) inadequate implementation and financing of digital applications. Conclusion Although promising approaches exist to structure and improve HF-care, across the four countries, implementation was reluctant to embrace novel methods. A lack of financial resources and insufficient digitalization making it difficult to adopt new concepts. Integration of HF-nurses seems to be an effective way of improving current models of HF-care. Digital solutions offer further opportunities to overcome communication and coordination gaps and to strengthen self-management skills.

ObjectiveHeart failure is a growing challenge to healthcare systems worldwide. Technological solutions have the potential to improve the health of patients and help to reduce costs. Acceptability is a prerequisite for the use and a successful implementation of new disruptive technologies. This qualitative study aimed to explore determinants that influence the acceptance of patients and their informal caregivers regarding a patient-oriented digital decision-making solution—a doctor-at-home system.DesignWe applied a semistructured design using an interview guide that was based on a theoretical framework influenced by established acceptance theories. The interviews were analysed using a content analysis.SettingA multicentred study in four European countries.ParticipantsWe interviewed 49 patients and 33 of their informal caregivers. Most of the patients were male (76%) and aged between 60 and 69 years (43%). Informal caregivers were mostly female (85%). The majority of patients (55%) suffered from heart failure with mild symptoms.ResultsFour main categories emerged from the data: needs and expectations, preferences regarding the care process, perceived risk and trust. Participants expressed clear wishes and expectations regarding a doctor-at-home, especially the need for reassurance and support in the management of heart failure. They were receptive to changes to the current healthcare processes. However, trust was identified as an important basis for acceptance and use. Finally, perceived risk for decision-making errors is a crucial topic in need of attention.ConclusionPatients and informal caregivers see clear benefits of digitalisation in healthcare. They perceive that an interactive decision-making system for patients could empower and enable effective self-care. Our results provide important insights for development processes of patient-centred decision-making systems by identifying facilitators and barriers for acceptance. Further research is needed, especially regarding the influence and mitigation of patients and informal caregivers’ perceived risks.

Background Cachexia is a complex and multifactorial syndrome defined as severe weight loss and muscle wasting which frequently goes unrecognised in clinical practice [ 1 ]. It is a debilitating syndrome, resulting in patients experiencing decreased quality of life and an increased risk of premature death; with cancer cachexia alone resulting in 2 million deaths per annum [ 2 ]. Most work in this field has focused on cancer cachexia, with cardiac cachexia being relatively understudied – despite its potential prevalence and impact in patients who have advanced heart failure. We report here the protocol for an exploratory study which will: 1. focus on determining the prevalence and clinical implications of cardiac cachexia within advanced heart failure patients; and 2. explore the experience of cachexia from patients’ and caregivers’ perspectives. Methods A mixed methods cross-sectional study. Phase 1: A purposive sample of 362 patients with moderate to severe heart failure from two Trusts within the United Kingdom will be assessed for known characteristics of cachexia (loss of weight, loss of muscle, muscle mass/strength, anorexia, fatigue and selected biomarkers), through basic measurements (i.e. mid-upper arm circumference) and use of three validated questionnaires; focusing on fatigue, quality of life and appetite. Phase 2: Qualitative semi-structured interviews with patients ( n  = 12) that meet criteria for cachexia, and their caregivers (n = 12), will explore their experience of this syndrome and its impact on daily life. Interviews will be digitally recorded and transcribed verbatim, prior to qualitative thematic and content analysis. Phase 3: Workshops with key stakeholders (patients, caregivers, healthcare professionals and policy makers) will be used to discuss study findings and identify practice implications to be tested in further research. Discussion Data collected as part of this study will allow the prevalence of cardiac cachexia in a group of patients with moderate to severe heart failure to be determined. It will also provide a unique insight into the implications and personal experience of cardiac cachexia for both patients and carers. It is hoped that robust quantitative data and rich qualitative perspectives will promote crucial clinical discussions on implications for practice, including targeted interventions to improve patients’ quality of life where appropriate.

BackgroundSGLT2 inhibitors have quickly become established as a first line therapy for the treatment of heart failure with reduced ejection fraction (HFreF) (1). Furthermore, mounting evidence has highlighted their benefit across a range of ejection fraction; however, it is unclear whether their effect may be attenuated in patients who do not experience LV remodeling (2).AimWe sought to evaluate if symptomatic benefit from SGLT2 inhibition, as defined by quality of life (QoL) outcomes, occurred independently to reverse cardiac remodeling.MethodWe performed a retrospective data analysis of patients with HFrEF and HFpEF who were commenced on a SGLT2 inhibitor and underwent serial echocardiography.The primary endpoints were change in New York Heart Association (NYHA) score and left ventricular ejection fraction (LVEF) from baseline to six months.Data were extracted from local healthcare records. Data expressed as mean+/-standard deviation with p<0.05 defined as significant. Variance between groups analysed using paired students t test. Interaction of LV reverse remodeling on NYHA was assessed using a two-way repeated measures ANOVA. Statistical analysis performed using SPSS.ResultsA total of 73 patients commenced on a SGLT2i underwent serial echocardiography. Baseline demographics were similar between groups (Figure 1). At six months, 30 patients (70% male) had a significant improvement in LVEF (30.5+/-9.3% to 47.7+/-7.6%, p<0.01) and 43 patients (77% male) did not (33.8+/-9.4% to 34.8+/-8.3%, p=ns). In the static LVEF group, mean NYHA score was significantly improved at 6 months (2.3+/-0.9 to 2+/-0.7, p=0.02). Similarly, in the improved LV group there was a significant difference in NYHA score (1.9+/-0.8 to 1.5+/-0.6, p=0.03) (Figure 2). There was no significant interaction between LV reverse remodeling and degree of NYHA improvement (F[2, 22] =0.26, p=0.87, partial η2 =0.01).ConclusionThis data suggests that improvements in QoL markers of heart failure occur independently to reverse cardiac remodeling following treatment with SGLT2 inhibition. This suggests that mechanisms underpinning these effects may be independent to reverse cardiac remodeling.Abstract 147 Figure 1Bar graph demonstarting change in NYHA score following six months SGLT2i theraphy in patients with and without LV remodelling. In the static LVEF group, mean NYHA score was significantly improved at 6 months (2.3+/-0.9 to 2+/-0.7,p=0.02).Similarly,in the improved LV group there was a significant difference in NYHA score (1.9+/-0.8 to 1.5+/-0.6,p=0.03). There was no significant interaction between LV reverse remodelling and degree of NYHA improvement (F[2,22]=0.26,p=0.87,partial η2=0.01)Conflict of InterestNONE

IntroductionSeveral landmark randomised-controlled trials (RCT)’s have demonstrated the efficacy of sodium-glucose co-transport 2 (SGLT2) inhibitors in reducing all-cause mortality, cardiovascular (CV) mortality and rates of heart failure (HF) hospitalisations (1). Much interest surrounds their mechanism of action and whether they have direct effects on reverse cardiac remodeling (2). Therefore, we conducted a meta-analysis of placebo controlled RCTs evaluating the impact of SGLT2 inhibition on cardiac remodeling in patients with HF.MethodsWe performed a systematic review and meta-analysis in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement and Cochrane Collaboration (3). Data interrogation of each major database including PubMed, EMBASE, MEDLINE and Cochrane Library was performed. Randomised-controlled trials evaluating patients >18 years with HF reduced ejection fraction and HF preserved ejection fraction treated with a SGLT2 inhibitor versus placebo-control were included (4–10). Outcome measures included left ventricular end diastolic volume and volume index [LVEDV (mls)/LVEDVi (mls/m2)], Left ventricular end systolic volume and volume index [LVSDV (mls) /LVSDVi (mls/m2)], Left ventricular ejection fraction (LVEF) (%), Left ventricular mass index [LVMi] (g/m2) and left ventricular global longitudinal strain (LV GLS) (%). The mean difference (MD) and standard error were extracted from each study and a random effects model utilised for analysis. Risk of bias of the included studies was assessed using a detailed framework provided by the Cochrane Handbook for Systematic Reviews of Interventions with a planned sensitivity analysis restricting analysis to studies assessed to have low risk. Additionally, given the differing imaging modalities used, robustness of effect was effect was further assessed using the standardized mean difference (SMD). A pre-specified subgroup analysis was performed to stratify results according to imaging modality used (cardiac MRI and echocardiography) with a further analysis delineating effect by LVEF.ResultsThe 7 final included studies were randomised, placebo-controlled trials in patients with heart failure comprising a total population of 620 patients (75% male). Baseline LVEF ranged from 29+/-8% to 55.2+/-4.2% and follow-up ranged from 12 weeks to 1 year with studies employing cardiac MRI (n=4) and echocardiography (n=3). Pooled data demonstrated that SGLT2 inhibition, compared to placebo control, resulted in significant improvements in LVEDV (mean difference -10.92 mls [95% CI: -16.73 to -5.11; z =3.68, p= 0.002]), LVEDVi (mean difference -5.78 mls [95% CI -10.30 to -1.26; z=2.51; p=0.01]), LVESV (mean difference –12.47 mls [95% CI -19.12 to -5.82; Z=3.68; P=0.0002]) (figure 1), LVESVi (mean difference -6.02 mls [95% CI -10.34 to -1.70; z=2.73: p=0.006]), LVM (mean difference -9.77 g [95% CI: -17.65 to -1.89: z=2.43: p=0.02]) and LVEF (mean difference +2.45 mls [95% CI 1.12 to 3.78: z=3.62: p=0.0003]) (figure 2). Only three studies assessed GLS (n=327) with no significant treatment effect noted (mean difference +0.42% [95%CI -0.19 TO 1.02; P=0.18]). Significant differences between baseline LVEF <40% and >40% were evident with loss of effect noted in patients with LVEF >40% with respect to reverse remodeling of LVESV (Chi2=4.05, df=1, p=0.04, I2=75.3%) and LVMi (Chi2=4.44, df=1, p=0.04, I2=77.5%).ConclusionThis meta-analysis of seven placebo-controlled, randomised trials, provides an additional data and insight into the effects of SGLT2 inhibition on reverse cardiac remodeling in patients with heart failure. Compared to placebo control, we found that treatment with a SGLT2 inhibitor produced significant improvements in several markers of reverse cardiac remodeling, specifically, LVESV, LVESVi, LVEDV, LVEDVi, LVM, LVMi and LVEF. These effects appeared more pronounced in patients with a baseline LVEF <40%.Abstract 155 Figure 1Five studies assessed LVEDVi (mls) (n=498) and LVESVi (mls) (n=498) with pooled data demonstrating that SGLT2 inhibition, compared to controls, significantly decreased a). LVESVi (mean difference -6.02 mls [95% CI -10.34 to -1.70; Z=2.73; P=0.0006]) and b). LVEDVi (mean difference -5.78 mls [95% CI: -10.30 to -1.26; z =2.52, p= 0.01)]. There were no significant differences between imaging modality used for LVEDVi (CMR versus echocardiography; Chi2=0.22, df=1, p=0.64, I2=0%) or LVESVi (CMR versus echocardiography; Chi2=0.43, df=1, p=0.51, I2=0%)Abstract 155 Figure 2a). Four studies assessed LVMi (n=410) with SGLT2 inhibition producing significant reductions versus placebo control (mean difference -9.77 mls [95% CI: -17.65 to -1.89: z=2.43: p=0.02]). b). LVEF was measured in seven studies (n=616) with a significant improvement noted with SGLT2 inhibition compared to control (mean difference +2.45 mls [95% CI 1.12 to 3.78: z=3.62: p=0.0003]). There was no significant difference between imaging modality used for LVMi (CMR versus echocardiography; Chi2=1.62, df=1, p=0.20, I2=38.4%) or LVEF (Chi2=0.02, df=1, p=0.89, I2=0%). *EMPA-VISION provided two cohorts within one study therefore are presented separatelyConflict of InterestNone

Cardiac magnetic resonance (CMR) is used in the diagnosis and risk stratification of hypertrophic cardiomyopathy (HCM) and can detect myocardial replacement fibrosis (anindependent predictor of adverse cardiac outcomes) using late gadolinium enhancement (LGE). We retrospectively analysed CMR studies carried out over a 2 year period identifying those which were diagnostic of HCM. 117 cases were analysed. Mean age of subjects was 53 years and 78 (67%) were male. Mean ejection fraction (EF) was 68.3% with a mean left ventricular (LV) mass index of 89.4 g/m². Hypertrophy was predominantly asymmetric in 94 (80%). All subjects received gadolinium and 80 (68%) had evidence of LGE. LVEF was lower (67 vs. 71%; p = 0.015) and LV mass index higher (94 vs. 81 g/m²; p = 0.007) in the LGE group. The proportion of patients with at least 1 clinical risk factor for sudden cardiac death (SCD) was similar in groups with and without LGE (48% vs. 32%; p = 0.160). In this study, a significant proportion (62%) of patients without clinical risk factors for SCD were found to have LGE on CMR. These patients would not currently be considered for therapy with an implantable cardiac defibrillator. 1. Patients with HCM are at increased risk of SCD, but identifying patients who may benefit from implantable defibrillators is difficult. 2. LGE is associated with adverse cardiovascular outcomes in HCM, but is present in a large proportion of patients. 3. Many patients without clinical risk factors for SCD have LGE and would not currently be considered for an implantable cardiac device.

Informal carers (i.e., family members or friends) of patients with heart failure are ill-prepared and under-supported for their caregiving role. To address this issue, the HEart faiLure carer support Programme was co-designed with carers and healthcare professionals, with pilot testing demonstrating intervention feasibility and acceptability. In the current article, we present the study protocol for evaluating the implementation and impact of the HEart faiLure carer support Programme in real-world, clinical settings across the United Kingdom (ClinicalTrials.gov ID: NCT07373041). A mixed-method, implementation study adopting a multi-centre, prospective cohort study design, with nested process and economic evaluations will be conducted. Nurses will deliver the HEart faiLure carer support Programme to 180 carers of patients with symptomatic heart failure across five sites spanning three nations of the United Kingdom (Northern Ireland, England, and Scotland). The patients (approximately 180) of carers enrolled in the project will be invited to provide outcome data. Recruited carers will receive weekly, nurse-led, online support group sessions and supplementary, self-directed educational resources (a booklet and website) for six weeks. Quantitative (i.e., questionnaires and logs) and qualitative (i.e., interviews) data will be collected from carers, patients, and healthcare professionals throughout the study. These data will evaluate the acceptability, fidelity, context, economic cost, and impact of HEart faiLure carer support Programme delivery in real-world clinical settings. An integrative analysis with mapping to the Consolidated Framework for Implementation Research and Normalisation Process Theory domains will be conducted, which will identify key synergies across quantitative and qualitative data sets. The results will elucidate the factors underpinning successful intervention translation to clinical practice and identify any required contextual adaptations, along with generating preliminary evidence of intervention impact. These findings will inform a large-scale, type 2 hybrid study, advancing the HEart faiLure carer support Programme towards routine rollout across the United Kingdom.