Early integration of palliative care versus standard cardiac care for patients with heart failure (EPCHF): a multicentre, parallel, two-arm, open-label, randomised controlled trial.

BACKGROUND: Heart failure is a substantial global health concern that severely affects patients' quality of life. We aimed to compare the effects of early integration of palliative care (EIPC) and standard cardiac care on health status and mood of patients with non-terminal heart failure. METHODS: EPCHF was a multicentre, parallel, two-arm, open-label, randomised controlled trial carried out at University Hospital Bonn and University Hospital Düsseldorf in Germany. Eligible patients (aged 18 years or older) had heart failure, with New York Heart Association class II or more and NT-proBNP concentrations greater than or equal to 400 pg/mL. Patients were randomly assigned (1:1) to receive EIPC with standard cardiac care or standard cardiac care alone. Randomisation was computer-generated with allocation concealment, variable block sizes, and stratification by investigational site. The primary endpoints were health status and mood, measured every 3 months over 12 months using the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-PAL) and the Kansas City Cardiomyopathy Questionnaire (KCCQ), analysed by intention to treat. This trial is registered with DRKS.de, DRKS00013922. FINDINGS: Between May 21, 2019, and Nov 15, 2021, 843 patients were assessed for eligibility, 205 of whom were enrolled (100 assigned to EIPC and 105 assigned to standard cardiac care). 143 (70%) patients were male and 62 (30%) were female. Over 12 months, both groups significantly improved in FACIT-PAL and KCCQ Overall Summary Score (OSS) with no significant differences between the groups (FACIT-PAL adjusted mean difference 0·98 points [95% CI -1·28 to 3·23]; p=0·40; KCCQ-OSS adjusted mean difference -2·06 points [-7·89 to 3·78]; p=0·49). Nine (9%) patients in the EIPC group and seven (7%) patients in the standard cardiac care group died from any cause, with no significant differences in time to death between the two groups (hazard ratio [HR] 1·32 [95% CI 0·49 to 3·54]; p=0·58). 22 (22%) patients in the EIPC group and 21 (21%) patients in the standard cardiac care group were hospitalised at least once due to heart failure, with no significant differences in time to heart-failure-related hospitalisation between the two groups (HR 1·09 [0·61 to 1·98]; p=0·77). 70 (70%) patients in the EIPC group and 62 (59%) in the standard cardiac care group had any adverse events (p=0·10). INTERPRETATION: In this open-label, randomised clinical trial, standard cardiac care, featuring guideline-directed optimisation of medical therapy and regular 3-monthly follow-ups was found to be as effective as when combined with EIPC in improving health status and mood in patients with non-terminal heart failure. Future clinical practices should consider EIPC based on individual patient needs. FUNDING: Federal Ministry of Education and Research.

Clinical effects of cognitive behavioral therapy in heart failure patients: a meta-analysis of randomized controlled trials.

BACKGROUND: About 20-40% of people with Heart failure (HF) suffer from some depression, which is 4-5% greater than the overall population. This depression can lead to undesirable outcomes, including elevated mortality rate and frequent hospitalization. PURPOSE: The current study aims to evaluate the impact of cognitive behavioural therapy (CBT) on self-care and the symptoms of depression and anxiety in HF patients. METHODS: We searched PubMed, Web of Science (WOS), Scopus, and Cochrane Library till 15 October 2022. All relevant randomized controlled trials (RCTs) were included. The data were extracted and pooled using Review Manager software (RevMan 5.4). Continuous data were pooled as mean difference and 95% confidence interval (CI). RESULTS: Our search retrieved 1146 records, and 7 studies (611 patients) were finally included. We assessed the Beck Depression Inventory-II (BDI-II) as the primary outcome of the study. Hamilton Rating Scale for Depression (HRSD-17), Change in Beck Anxiety Inventory, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Self-Care of Heart Failure Index (SCHFI) were also assessed as secondary outcomes. With CBT, BDI-II showed a significant reduction after 4 to 6 months follow-up (MD = -4.87, 95% CI: [-8.06; -1.69], P = 0.003) as well as 8 to 9 months follow-up (MD = -5.71, 95% CI: [-8.95; -2.46], P = 0.0006). But no significant difference was shown with 3 months follow-up (M.D=-4.34; 95%CI: [-10.70; 2.03], P = 0.18). CONCLUSIONS: CBT has long-term (4-9 months) significant favorable outcomes decreasing anxiety and depression compared to non-CBT groups. No significant short-term (less than 3 months) impact on HF patients' self-care, depression, or anxiety were shown.

Rationale and design of the EPCHF trial: the early palliative care in heart failure trial (EPCHF).

The progressive nature of heart failure (HF) coupled with high mortality and poor quality-of-life (QoL) mandates greater attention to palliative care (PC) as a routine component of HF management. Limited evidence exists from randomized controlled trials supporting the use of interdisciplinary palliative care in the progressive course of HF. The early palliative care in heart failure trial (EPCHF) is a prospective, controlled, nonblinded, multicenter study of an interdisciplinary palliative care intervention in 200 patients with symptomatic HF characterized by NYHA ≥ 2. The 12-month EPCHF intervention includes monthly consultations by a palliative care team focusing on physical and psychosocial symptom relief, attention to spiritual concerns and advance care planning. The primary endpoint is evaluated by health-related QoL questionnaires after 12 months of treatment. First the functional assessment of chronic illness therapy palliative care (FACIT-Pal) score evaluating QoL living with a chronic disease and second the Kansas City cardiomyopathy questionnaire (KCCQ) measuring QoL living with heart failure will be determined. Secondary endpoints are changes in anxiety/depression (HADS), symptom burden score (MIDOS), spiritual well-being functional assessment of chronic illness therapy spiritual well-being scale (FACIT-Sp), medical resource and cost assessment. EPCHF will help evaluate the efficacy and cost-effectiveness of palliative care in symptomatic HF using a patient-centered outcome as well as clinical and economic endpoints. EPCHF is funded by the Bundesministerium für Bildung und Forschung (BMBF, 01GY17).

Health Status After Transcatheter Tricuspid Valve Repair in Patients With Functional Tricuspid Regurgitation.

OBJECTIVES: The aim of this study was to investigate changes in quality of life (QoL) after transcatheter tricuspid valve repair (TTVR) for tricuspid regurgitation (TR). BACKGROUND: TTVR provides feasible and durable efficacy in reducing TR, but its clinical benefits on QoL still remain unclear. METHODS: In 115 subjects undergoing TTVR for severe functional TR, QoL was evaluated using the 36-Item Short Form Health Survey (SF-36) and the Minnesota Living With Heart Failure Questionnaire (MLHFQ). All-cause mortality, heart failure (HF) rehospitalization, and a composite endpoint of all-cause mortality, HF rehospitalization, and repeat TTVR were recorded as clinical events. RESULTS: Successful device implantation was achieved in 110 patients (96%). Moderate or less TR at discharge was achieved in 95 patients (83%). Mean SF-36 physical component summary (PCS) score improved from 34 ± 9 to 37 ± 9 points (+3 points; 95% CI: 1-5 points; P = 0.001), mean SF-36 mental component summary score improved from 49 ± 9 to 51 ± 10 points (+2 points; 95% CI: 0-4 points; P = 0.017), and mean MLHFQ score decreased from 29 ± 14 to 20 ± 15 points (-8 points; 95% CI: -11 to -5 points; P < 0.001). Baseline PCS, moderate or less TR at discharge, and baseline massive or torrential TR were associated with 1-month change in PCS score (P < 0.05). Change in PCS score after 1 month predicted HF rehospitalization after TTVR (adjusted HR: 0.74 [95% CI: 0.60-0.92] per 5-point increase in PCS score; P = 0.008). CONCLUSIONS: This study demonstrates that TTVR provides improvement in QoL in patients with relevant TR. TR reduction to a moderate or less grade was associated with improvement of SF-36 and MLHFQ scores. Further, global QoL was associated with clinical outcomes and might serve as a future outcome surrogate following TTVR.