Minnesota Living With Heart Failure Research Articles

Depression and anxiety in Greek heart failure patients who received a cardiac resynchronization therapy device and did not receive shock therapy during a 12-month follow-up

Abstract Background/Introduction Cardiac resynchronization therapy (CRT) represents an effective therapy in selected heart failure with reduced ejection fraction (HFrEF) patients. There are racial, social, geographical, and ethnic differences in the perception of cardiac device therapies as well as in the associated depression and anxiety status. Regarding psychological status indexes in CRT patients, heterogenous results have been reported while data on their variation over time are limited. No relative data regarding Greek patients have been published in the literature. Purpose We aimed to study psychological status and quality of life validated parameters at baseline as well as their variation at 6 and 12 months after implantation of a CRT device in Greek adult patients with HFrEF. Methods We recruited consecutive HFrEF adult patients who were implanted a CRT device (defibrillator or pacemaker). From the present analysis we excluded patients who suffered defibrillator shocks, those with neuropsychiatric disorders, and those with severe chronic medical illnesses or disabilities. Baseline demographic, clinical, laboratory, electrocardiographic, and echocardiographic parameters were carefully recorded. The following scores were assessed at baseline as well as 6 and 12 months after implantation: Minnesota Living with Heart Failure (MLHF), GAD-7 Anxiety, and PHQ-9 Depression. The variation of these scores over time was examined using the non-parametric Friedman’s test. Potential correlations of the baseline scores with other parameters were examined using the Spearman rank test. Comparison of these scores between different groups of patients was examined using the Mann-Whitney U test. Results The initial study population consisted of 105 patients, but after excluding 8 patients who experienced defibrillator shocks, we finally analyzed 97 patients (median age: 72 [64-76.5] years, 76% men). Six patients died during the 12-month follow-up. At baseline the MLHF score was 37 [20 - 56], at 6 months it was 1 [0 – 8], and at 12 months 0.5 [0-10]. The PHQ-9 score for depression at baseline was 9 [3.75 – 14.25], at 6 months it was 0.5 [0 – 2], and at 12 months it was 0.25 [0 – 1.5]; p <0.01. The GAD-7 anxiety score at baseline was 8 [2 – 16], at 6 months it was 0.5 [0 – 2], and at 12 months it was 0.5 [0 – 2.5]; p <0.01. At baseline 29% of patients had PHQ-9 score <5, namely minimal depression; and 35% had GAD-7 score <5, namely minimal anxiety. The baseline PHQ-9 and GAD-7 scores did not correlate to any other parameter while there were no differences between different patient groups. Baseline PHQ-9 and GAD-7 scores demonstrated strong correlation with the baseline MLHF score (p <0.01). Conclusions In Greek patients with HFrEF who were implanted a CRT device, depression was present in 71% and anxiety in 65% of them. The indexes of quality of life, anxiety, and depression were markedly reduced during the 12-month follow-up.

Exercise-based cardiac rehabilitation for adults with heart failure.

People with heart failure experience substantial disease burden that includes low exercise tolerance, poor health-related quality of life (HRQoL), increased risk of mortality and hospital admission, and high healthcare costs. The previous 2018 Cochrane review reported that exercise-based cardiac rehabilitation (ExCR) compared to no exercise control shows improvement in HRQoL and hospital admission amongst people with heart failure, as well as possible reduction in mortality over the longer term, and that these reductions appear to be consistent across patient and programme characteristics. Limitations noted by the authors of this previous Cochrane review include the following: (1) most trials were undertaken in patients with heart failure with reduced (< 45%) ejection fraction (HFrEF), and women, older people, and those with heart failure with preserved (≥ 45%) ejection fraction (HFpEF) were under-represented; and (2) most trials were undertaken in a hospital or centre-based setting. To assess the effects of ExCR on mortality, hospital admission, and health-related quality of life of adults with heart failure. We searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO and Web of Science without language restriction on 13 December 2021. We also checked the bibliographies of included studies, identified relevant systematic reviews, and two clinical trials registers. We included randomised controlled trials (RCTs) that compared ExCR interventions (either exercise only or exercise as part of a comprehensive cardiac rehabilitation) with a follow-up of six months or longer versus a no-exercise control (e.g. usual medical care). The study population comprised adults (≥ 18 years) with heart failure - either HFrEF or HFpEF. We used standard Cochrane methods. Our primary outcomes were all-cause mortality, mortality due to heart failure, all-cause hospital admissions, heart failure-related hospital admissions, and HRQoL. Secondary outcomes were costs and cost-effectiveness. We used GRADE to assess the certainty of the evidence. We included 60 trials (8728 participants) with a median of six months' follow-up. For this latest update, we identified 16 new trials (2945 new participants), in addition to the previously identified 44 trials (5783 existing participants). Although the existing evidence base predominantly includes patients with HFrEF, with New York Heart Association (NYHA) classes II and III receiving centre-based ExCR programmes, a growing body of trials includes patients with HFpEF with ExCR undertaken in a home-based setting. All included trials employed a usual care comparator with a formal no-exercise intervention as well as a wide range of active comparators, such as education, psychological intervention, or medical management. The overall risk of bias in the included trials was low or unclear, and we mostly downgraded the certainty of evidence of outcomes upon GRADE assessment. There was no evidence of a difference in the short term (up to 12 months' follow-up) in the pooled risk of all-cause mortality when comparing ExCR versus usual care (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.71 to 1.21; absolute effects 5.0% versus 5.8%; 34 trials, 36 comparisons, 3941 participants; low-certainty evidence). Only a few trials reported information on whether participants died due to heart failure. Participation in ExCR versus usual care likely reduced the risk of all-cause hospital admissions (RR 0.69, 95% CI 0.56 to 0.86; absolute effects 15.9% versus 23.8%; 23 trials, 24 comparisons, 2283 participants; moderate-certainty evidence) and heart failure-related hospital admissions (RR 0.82, 95% CI 0.49 to 1.35; absolute effects 5.6% versus 6.4%; 10 trials; 10 comparisons, 911 participants; moderate-certainty evidence) in the short term. Participation in ExCR likely improved short-term HRQoL as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire (lower scores indicate better HRQoL and a difference of 5 points or more indicates clinical importance; mean difference (MD) -7.39 points, 95% CI -10.30 to -4.77; 21 trials, 22 comparisons, 2699 participants; moderate-certainty evidence). When pooling HRQoL data measured by any questionnaire/scale, we found that ExCR may improve HRQoL in the short term, but the evidence is very uncertain (33 trials, 37 comparisons, 4769 participants; standardised mean difference (SMD) -0.52, 95% CI -0.70 to -0.34; very-low certainty evidence). ExCR effects appeared to be consistent across different models of ExCR delivery: centre- versus home-based, exercise dose, exercise only versus comprehensive programmes, and aerobic training alone versus aerobic plus resistance programmes. This updated Cochrane review provides additional randomised evidence (16 trials) to support the conclusions of the previous 2018 version of the review. Compared to no exercise control, whilst there was no evidence of a difference in all-cause mortality in people with heart failure, ExCR participation likely reduces the risk of all-cause hospital admissions and heart failure-related hospital admissions, and may result in important improvements in HRQoL. Importantly, this updated review provides additional evidence supporting the use of alternative modes of ExCR delivery, including home-based and digitally-supported programmes. Future ExCR trials need to focus on the recruitment of traditionally less represented heart failure patient groups including older patients, women, and those with HFpEF.

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

What is the relationship between blood tests for iron deficiency, including anaemia, and the response to intravenous iron in patients with heart failure? In the IRONMAN trial, 1137 patients with heart failure, ejection fraction ≤ 45%, and either serum ferritin < 100 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. 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 ≥100 µg/L, was associated with higher event rates and greater absolute reductions in events with FDI, albeit not statistically significant. This hypothesis-generating analysis suggests that anaemia or TSAT < 20% with ferritin > 100 µg/L might identify patients with heart failure who obtain greater benefit from intravenous iron. This interpretation requires confirmation.

The Six-Minute Walk as A Safety Exercise in Improving the Health-Related Quality of Life Among Heart Failure Patients: A Preliminary Research

The prevalence of heart failure patients is steadily increasing worldwide. The quality of life among them was also shown to be decreasing day by day. Inadequate health-related quality of life in heart failure patients leads to an increase in mortality rate. Thus, effective management of heart failure patients is essential. The present study was to examine the intervention based on the six-minute walk test to improve health-related quality of life for patients with heart failure. A quasi-experimental study was conducted in the cardiovascular center of the acute care setting. The Six-minute Walk Test (6MWT), in accordance with the American Thoracic Society guideline, was implemented as the intervention procedure. The Minnesota Living with Heart Failure (MLWHF) was used to measure the health-related quality of life of patients. Fifteen heart failure patients enrolled in the study for a month; 73.3% were male with a mean age of 57.47 (SD 14.32). Overall, the health-related quality of life in heart failure patients was poor at the baseline of the study, then their quality of life significantly increased to good quality after implementing the 6MWT. An improvement in the functional performance was also found among them. This study indicates that the 6MWT was suitable, safe, and simply performed in heart failure patients, which can effectively improve the health-related quality of life of patients with heart failure.

Abstract 18085: Effect of Therapies on Quality of Life in Heart Failure With Reduced Ejection Fraction: A Systematic Review and Meta-Analysis

Introduction: Minnesota Living with Heart Failure (MLWHF) questionnaire is a validated tool to assess quality of life in patients with heart failure with reduced ejection fraction (HFrEF) Hypothesis: We performed this systematic review and meta-analysis to evaluate the effect of therapies on improvement in MLWHF; analyzed across randomized controlled trials (RCTs) of drug based therapy, device based therapy, autonomic modulation, and exercise. Methods: We conducted a systematic search of MEDLINE and EMBASE for RCTs measuring MLWHF at baseline and follow-up in patients with HFrEF. Primary outcome was improvement in MLWHF. Meta-analysis was stratified in groups based on medical therapy, device based therapy (cardiac resynchronization therapy and cardiac contractility modulation), autonomic modulation (vagus nerve stimulation and baroreflex activation therapy), and exercise. Mean difference (MD) with 95% Confidence Interval (CI) were reported across multiple studies included in meta-analysis. Results: A total of 23 studies met the inclusion criteria. Analysis showed statistically significant improvement in MLWHF at follow-up for drug based therapy (MD: -2.77; 95% CI: -5.10, -0.44) (Panel A), device based therapy (MD: -6.86; 95% CI: -9.60, -4.12) (Panel B), autonomic modulation (MD: -15.21; 95% CI: - 19.25, -11.17) (Panel C), and exercise group (MD: -10.05; 95% CI: -16.66, -3.43) (Panel D). Sub-group analyses based on various treatment modalities showed statistically significant improvement in MLWHF at follow-up for cardiac resynchronization therapy (MD: -8.11; 95% CI: -11.88, -4.33), cardiac contractility modulation (MD: -5.47; 95% CI: -9.46, -1.49), and baroreflex activation therapy (MD: -19.79; 95% CI: -24.90, -14.67). Conclusions: Drug based therapy, device based therapy, autonomic modulation, and exercise are associated with improvement in quality of life in patients with HFrEF.

Abstract 13991: Sleep Patterns and Quality of Life in Pulmonary Arterial Hypertension

Introduction: Data on sleep duration and quality of life (QOL) in PAH are limited to self-reported surveys. Commercial wearables represent a cost-effective, low-burden approach to objectively assess real-world sleep patterns. We aimed to describe sleep patterns and associations with quality of life (QOL) in a cohort of PAH patients. Methods: We enrolled patients with expert adjudicated PAH from the NHLBI-funded Pulmonary Vascular Disease Phenomics (PVDOMICS) and compared them with individuals from the All of Us Research Program matched on age, sex, body mass index, and monitoring dates. Sleep variables were measured using Fitbit devices, which patients wore continuously for 12 weeks at baseline and again after 1 year. In PAH patients, QOL (Minnesota Living with Heart Failure (MLHF) survey) was assessed at baseline and 1 year; higher MLHF scores indicate greater impairment. Results: We enrolled 36 patients with PAH (48.9 ± 13.2 years, 81% female). Total minutes in bed and total minutes per sleep stage at baseline and 1 year follow-up are shown in Table 1. Compared with matched controls, patients with PAH have similar minutes in bed and asleep but markedly reduced minutes of deep (p&lt;0.001) and REM sleep (p &lt;0.001). In the PAH cohort, changes in sleep parameters from baseline to year 1 correlated inversely with changes in MLHF emotional score from baseline to year 1 including: time in bed (r = - 0.61, p = 0.017), total minutes asleep (r = -0.59, p = 0.020), total minutes light sleep (r = -0.53, p = 0.041), and total minutes deep sleep (r = - 0.52, p = 0.047). Minutes of deep and REM sleep over 1 year were inversely correlated with medication escalation over that year (rs = -0.49 and -0.47, p&lt;0.02 for both). No sleep measures correlated with baseline 6-minute walk distance. Conclusions: Patients with PAH have poor sleep quality compared to healthy controls. Poor sleep quality may contribute to or result from some of the common symptoms of PAH such as fatigue, mood disorders, and decreased QOL.

Reliability and Validity of Kansas City Cardiomyopathy Questionnaire in Arabic Patients with Chronic Heart Failure.

Background: The Kansas City Cardiomyopathy Questionnaire (KCCQ) is the most specific and widely used questionnaire for assessing health-related quality of life (HRQoL) in chronic heart failure (CHF). This study aimed to examine reliability and validity of the KCCQ in Arabic patients with CHF. Material and Methods: Patients with CHF filled out the Arabic versions of the Minnesota Living with Heart Failure (MLHF) and KCCQ questionnaire, and performed a six-minute walk test (6MWT) on their first visit. On the return, the patients filled out the KCCQ along with the global rating of change (GRC) scale. Internal consistency, test-retest reliability, and construct validity were examined. Results: A total of 101 Arabic patients with CHF, with a mean (SD) age of 55 (11) years old, completed the study. The Cronbach's alpha was 0.97, and the ICC2,1 = 0.95 (95%CI: 0.92 to 0.97, p < 0.001). The Arabic version of KCCQ was correlated with the MLHF (r = -0.57, p = 0.01) and with the 6MWT (r = 0.70, p < 0.001). Conclusions: The Arabic version of KCCQ is a reliable and valid measure of HRQoL, which could be utilized in routine clinical practice for Arabic-speaking patients with CHF.

Physical Activity, Inactivity and Sleep in Individuals with Hypertrophic Cardiomyopathy.

Physical activity presents an important cornerstone in the management and care of individuals with hypertrophic cardiomyopathy (HCM). Twenty-one individuals with HCM (age: 52±15 years old, body mass index (BMI): 30±7 kg/m2) completed 7-day monitoring using wrist-worn triaxial accelerometers (GENEActiv, ActivInsights Ltd, UK) and were compared to age and sex-matched healthy controls (age: 51±14 years old, BMI: 25±4 kg/m2). For individuals with HCM, clinical parameters (left atrial diameter and volume, peak oxygen consumption, NTproBNP and Minnesota Living with Heart Failure (MLHF)) were correlated with accelerometry. After adjusting for BMI, individuals with HCM spent less time in moderate-vigorous physical activity (MVPA) (86 (55-138) vs. 140 (121-149) minutes/day, p<0.05) compared to healthy controls. Individuals with HCM engaged in fewer MVPA-5 min (6 (2-15) vs. 27 (23-37) minutes/day, p<0.01) and MVPA-10 min bouts (9 (0-19) vs. 35 (17-54) minutes/day, p<0.01) versus healthy controls. For HCM only, peak oxygen consumption was correlated with MVPA (r=0.60, p<0.01) and MVPA-5 min bouts (r=0.47, p<0.05). MLHF score was correlated with sleep duration (r=0.45, p<0.05). Individuals with HCM should be encouraged to engage in moderate-intensity physical activity bouts and reduce prolonged periods of inactivity in order to potentially improve exercise tolerance and reduce disease burden.

Atrial Fibrillation Ablation for Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial

BackgroundPatients with heart failure with preserved ejection fraction (HFpEF) frequently develop atrial fibrillation (AF). There are no randomized trials examining the effects of AF ablation on HFpEF outcomes. ObjectivesThe aim of this study is to compare the effects of AF ablation vs usual medical therapy on markers of HFpEF severity, including exercise hemodynamics, natriuretic peptide levels, and patient symptoms. MethodsPatients with concomitant AF and HFpEF underwent exercise right heart catheterization and cardiopulmonary exercise testing. HFpEF was confirmed with pulmonary capillary wedge pressure (PCWP) of 15 mm Hg at rest or ≥25 mm Hg on exercise. Patients were randomized to AF ablation vs medical therapy, with investigations repeated at 6 months. The primary outcome was change in peak exercise PCWP on follow-up. ResultsA total of 31 patients (mean age: 66.1 years; 51.6% females, 80.6% persistent AF) were randomized to AF ablation (n = 16) vs medical therapy (n = 15). Baseline characteristics were comparable across both groups. At 6 months, ablation reduced the primary outcome of peak PCWP from baseline (30.4 ± 4.2 to 25.4 ± 4.5 mm Hg; P < 0.01). Improvements were also seen in peak relative VO2 (20.2 ± 5.9 to 23.1 ± 7.2 mL/kg/min; P < 0.01), N-terminal pro–B-type natriuretic peptide levels (794 ± 698 to 141 ± 60 ng/L; P = 0.04), and MLHF (Minnesota Living with Heart Failure) score (51 ± −21.9 to 16.6 ± 17.5; P < 0.01). No differences were detected in the medical arm. Following ablation, 50% no longer met exercise right heart catheterization–based criteria for HFpEF vs 7% in the medical arm (P = 0.02). ConclusionsAF ablation improves invasive exercise hemodynamic parameters, exercise capacity, and quality of life in patients with concomitant AF and HFpEF.

Investigating Occupation, Ejection Fraction, and Comorbidity Factors with Quality of Life in Heart Failure Patients: A Cross-sectional Study in Indonesia

Background: Heart disease causes functional disorders that can cause the sufferer to experience fatigue and dyspnea, leading to low quality of life. Various factors related to the quality of life of heart failure patients include occupation and ejection fraction. The number of heart failure patients treated at Aceh government hospital is still high in 2021, as well as the incidence of recurrent hospitalization. Objectives: This study aimed to determine the relationship between occupation, ejection fraction, and heart failure patients' quality of life. Methods: The study used a quantitative research approach with a cross-sectional design. The sample was 154 heart failure patients who visited the Cardiac Polyclinic of a provincial hospital in Banda Aceh, Indonesia. Data on patient occupation, ejection fraction, and comorbidity factors were obtained from the sociodemographic and clinical characteristics of the respondents. Then, the patient’s quality of life was measured by the Minnesota Living with Heart Failure (MLHF) questionnaire. The chi-square test and logistic regression (with a significance level α = 0.05) were used in data analysis in this study. Results: The results of the study found a significant direct correlation between patient occupation (P = 0.001), ejection fraction (P = 0,001), and an inverse correlation of comorbidity factors (P = 0.001) with quality of life (α = 0.05). The multivariate analysis using logistic regression found that the dominant factor, ejection fraction, was associated with the quality of life of heart failure patients with OR: 12.033, followed by comorbidity factors (OR: 3.565) and occupation (OR: 1.819). Conclusions: The quality of life of heart failure patients is strongly associated with the ejection fraction in heart failure patients; therefore, maintaining the ejection fraction is needed to improve the quality of life.

Quality of Life and Type of Cardiac Resynchronization Therapy Device in Older Heart Failure Patients.

Background: Cardiac resynchronization therapy (CRT) improves quality of life (QOL) in heart failure (HF) patients with reduced ejection fraction. Clinicians may have difficulty choosing between CRT with a pacemaker (CRT-P) or a defibrillator (CRT-D) for older patients. CRT-P devices are smaller, have more battery longevity, are less prone to erosions or recalls, and do not deliver shocks. These factors may impact patients' QOL, but data on such comparisons are lacking. Objectives: We examined the impact of CRT-P versus CRT-D on the QOL of older (≥75 years) HF patients who qualified for implantable cardioverter defibrillator therapy. Settings/Subjects/Measurements: We enrolled 101 CRT recipients and assessed QOL at baseline and at six-month post-implant using the Short Form Health Survey (SF-36) and the Minnesota living with heart failure (MLHF) questionnaires. Results: The average age of enrolled patients was 81 years, 27% were women, and 40 received a CRT-P device. After adjusting for baseline QOL score, age, sex, HF functional class, and the occurrence of adverse events, we found no significant differences in QOL outcomes between CRT-P and CRT-D recipients based on either the subscales or the composite scores for the SF-36 or MLHF questionnaires at six-months post-implantation. Conclusions: Older CRT-P and CRT-D recipients report comparable QOL scores six months after device implantation. Larger cohort studies with longer follow-up are needed to accurately assess potential QOL differences between CRT-D and CRT-P recipients to guide clinical decision making and ensure the right balance of risk versus benefit in these patients. Appropriate goals-of-care discussions are the corner stone of clinical decision making regarding defibrillator therapy. As such, even as the data stand at present, there is a need for more deliberate referral of older patients with HF to Palliative Care Specialists, or to Cardiologists trained in Palliative Care Medicine. clinicaltrials.gov listing: NCT03031847.

Validity and Reliability of the Integrated Palliative Care Outcome Scale in Asian Heart Failure Patients.

The Integrated Palliative Care Outcome Scale (IPOS) was developed in the United Kingdom for health assessment in advanced illness. To evaluate the validity and reliability of a culturally adapted IPOS (both patient and staff versions) for heart failure (HF). We recruited HF patients and staff from a tertiary hospital in Singapore. We collected patient IPOS, New York Heart Association (NYHA) status, Edmonton Symptom Assessment System (ESAS) and Minnesota Living with Heart Failure (MLHF) scores at baseline, and patient IPOS at follow-up. Each baseline patient IPOS was matched with a staff IPOS. Pearson correlation coefficient (r) between ESAS, MLHF, and patient IPOS was calculated to assess construct validity. The two-sample T-test assessed difference in patient and staff IPOS scores across NYHA status and care settings for known-group validity. Internal consistency of patient and staff IPOS was assessed using Cronbach's alpha (α). Intraclass correlation coefficient (ICC) was used to assess test-retest reliability of patient IPOS and inter-rater reliability between patient and staff IPOS. Ninety-one patients and 12 staff participated. There was strong convergent validity of total patient IPOS with MLHF (r = 0.78) and ESAS (r = 0.81). There were statistically significant differences in total IPOS across care settings (patient-IPOS: 8.05, staff-IPOS 13.61) and NYHA (patient-IPOS: 7.52, staff-IPOS 12.71).There was high internal consistency of total patient (α = 0.83) and staff IPOS (α = 0.88) and high test-retest reliability of patient IPOS (ICC 0.81). Inter-rater reliability (ICC) ranged between 0.82 and 0.91. The IPOS was valid and reliable for HF patients in Singapore.

Relationship between NYHA degrees and Self-efficacy with Quality of Life in Heart Failure Patients: A Cross-Sectional Study

Heart failure causes functional limitations that result in fatigue and dyspnea, thereby reducing the quality of life. Various factors related to the quality of life of heart failure patients include NYHA degree and self-efficacy. An increase in the number of heart failure patients treated at the Aceh Government Hospital occurred in 2021, patients also often experienced repeated hospitalizations. This study aims to determine the relationship between patient NYHA degree and self-efficacy with the quality of life of patients with heart failure. This type of research is quantitative with a cross-sectional study on 154 heart failure patients. Instruments to measure self-efficacy using Cardiac Self-Efficacy (CSE) and quality of life with the Minnesota Living with Heart Failure (MLHF) questionnaire. Bivariate analysis using chi-square and multivariate analysis with logistic regression. The results showed a significant relationship between NYHA degree and self-efficacy with quality of life (p&lt;0.05). The results of the multivariate analysis found that the degree of NYHA was the most dominant factor associated with the quality of life of heart failure patients with an Odds Ratio (OR) of 17.438. The quality of life of heart failure patients is strongly influenced by the degree of NYHA, lowering the degree of NYHA is the best step to prevent a decrease in the quality of life of patients with heart failure.

Baroreflex activation therapy with the Barostim™ device in patients with heart failure with reduced ejection fraction: a patient level meta-analysis of randomized controlled trials.

Heart failure with reduced ejection fraction (HFrEF) remains associated with high morbidity and mortality, poor quality of life (QoL) and significant exercise limitation. Sympatho-vagal imbalance has been shown to predict adverse prognosis and symptoms in HFrEF, yet it has not been specifically targeted by any guideline-recommended device therapy to date. Barostim™, which directly addresses this imbalance, is the first Food and Drug Administration approved neuromodulation technology for HFrEF. We aimed to analyse all randomized trial evidence to evaluate the effect of baroreflex activation therapy (BAT) on heart failure symptoms, QoL and N-terminal pro-brain natriuretic peptide (NT-proBNP) in HFrEF. An individual patient data (IPD) meta-analysis was performed on all eligible trials that randomized HFrEF patients to BAT + guideline-directed medical therapy (GDMT) or GDMT alone (open label). Endpoints included 6-month changes in 6-min hall walk (6MHW) distance, Minnesota Living With Heart Failure (MLWHF) QoL score, NT-proBNP, and New York Heart Association (NYHA) class in all patients and three subgroups. A total of 554 randomized patients were included. In all patients, BAT provided significant improvement in 6MHW distance of 49 m (95% confidence interval [CI] 33, 64), MLWHF QoL of -13 points (95% CI -17, -10), and 3.4 higher odds of improving at least one NYHA class (95% CI 2.3, 4.9) when comparing from baseline to 6 months. These improvements were similar, or better, in patients who had baseline NT-proBNP &lt;1600 pg/ml, regardless of the cardiac resynchronization therapy indication status. An IPD meta-analysis suggests that BAT improves exercise capacity, NYHA class, and QoL in HFrEF patients receiving GDMT. These clinically meaningful improvements were consistent across the range of patients studies. BAT was also associated with an improvement in NT-proBNP in subjects with a lower baseline NT-proBNP.

Impact of Clinical Characteristics on Quality of Life of Heart Failure Patients

Objective: This study aimed to determine impact of clinical characteristics on quality of life (QoL) in heart failure patients.&#x0D; Methods: A cross-sectional study using a newly developed and validated research tool and Minnesota Living with Heart Failure (MLHF) research tool, was conducted in heart failure patients. Data was collected by convenience sampling method. Descriptive, comparative, and inferential statistics were used by Statistical Package for the Social Sciences (SPSS) ver. 24 to determine the sociodemographic correlates of QoL in heart failure patients.&#x0D; Results: The majority of the studied heart failure patients were male 103 (58.2%) and the females were 74 (41.8%). The most of the studied heart failure patients were from &gt; 60 years of age group 73 (41.2%). In Spearman’s correlation analysis, statistically non-significant (p &gt;0.05), weak and positive associations were observed. The studied clinical variables like disease duration, total no. of comorbidities, types of comorbidities i.e., HPT, dyslipidemia, renal problems, Diabetes mellitus (DM) and others, hospital admissions, no. of current medications were found to have positive correlation with patients overall QoL.&#x0D; Conclusion: The study results concluded a weak but positive correlation between various studied clinical characteristics and QoL of the heart failure patients.

THE IMPACT OF TELEHOMECARE ON HEART FAILURE PATIENTS, NURSES, AND INFORMAL CAREGIVERS: A LONGITUDINAL COHORT STUDY

THE IMPACT OF TELEHOMECARE ON HEART FAILURE PATIENTS, NURSES, AND INFORMAL CAREGIVERS: A LONGITUDINAL COHORT STUDY

Improvement in quality of life with sacubitril/ /valsartan in cardiac resynchronization non-responders: The RESINA (RESynchronization plus an Inhibitor of Neprilysin/Angiotensin) registry.

Clinical management of cardiac resynchronization therapy (CRT) non-responders is difficult, and their prognosis is poor. The aim of the present study was to evaluate whether treatment with sacubitril/valsartan can improve quality of life (QoL) parameters in these patients. Thirty five non-responders to CRT were included (75 ± 7 years, 28% females, mean left ventricular ejection fraction 28 ± 8%, 54% non-ischemic cardiomyopathy) with maximally optimized drug therapy and New York Heart Association class II-III. They were all on angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers and were switched to sacubitril/valsartan. One week before and 6 months after initiation of the therapy they completed both the Minnesota Living with Heart Failure (MLWHF) and the 12-item Kansas City Cardiomyopathy Questionnaires (KCCQ-12). The primary outcome was the effect of sacubitril/valsartan on the physical, clinical, social and emotional QoL parameters and number of hospitalizations. The mean total scores of both questionnaires improved from baseline to the follow-up visit at 6-months (KCCQ-12 40 ± 10 to 47 ± 10; p < 0.001; MLWHF 40 ± 15 to 29 ± 15; p < 0.001). The best results were seen in the KCCQ-12 total symptom domains (77% improvement), the MLWHF physical domain (81% improvement), and the MLWHF emotional domain (71% improvement). Two patients died during follow-up. The mean number of hospitalizations reduced significantly (1 ± 0.6 vs. 0.5 ± 0.8; p = 0.003) CONCLUSIONS: In CRT non-responders, sacubitril/valsartan significantly improved overall QoL, physical limitations and emotional domains and reduced the number of hospitalizations.

A prospective STudy using invAsive haemodynamic measurements foLLowing catheter ablation for AF and early HFpEF: STALL AF-HFpEF.

The impact of atrial fibrillation (AF) ablation in early heart failure with preserved ejection fraction (HFpEF) is unknown. Our aim was to determine the impact of AF ablation on symptoms and exercise haemodynamic parameters of early HFpEF. Symptomatic AF patients referred for index AF ablation with ejection fraction ≥50% underwent baseline quality of life questionnaires, echocardiography, cardiac magnetic resonance imaging, exercise right heart catheterisation (exRHC), and brain natriuretic peptide (BNP) testing. HFpEF was defined by resting pulmonary capillary wedge pressure (PCWP) ≥15 mmHg or peak exercise PCWP ≥25 mmHg. Patients with HFpEF were offered AF ablation and follow-up exRHC ≥6months post-ablation. Of 54 patients undergoing baseline evaluation, 35 (65%) had HFpEF identified by exRHC. HFpEF patients were older (64 ± 10 vs. 54 ± 13 years, P < 0.01), and more frequently female (54% vs. 16%, P < 0.01), hypertensive (63% vs. 16%, P < 0.001), and suffering persistent AF (66% vs. 11%, P < 0.001), compared to those without HFpEF. Twenty HFpEF patients underwent AF ablation and follow-up exRHC 12 ± 6months post-ablation. Nine (45%) patients no longer fulfilled exRHC criteria for HFpEF at follow-up. Patients remaining arrhythmia free (n = 9, 45%) showed significant improvements in peak exercise PCWP (29 ± 4 to 23 ± 2 mmHg, P < 0.01) and Minnesota Living with Heart Failure (MLHF) score (55 ± 30 to 22 ± 30, P < 0.01) while the remainder did not (PCWP 31 ± 5 to 30.0 ± 4 mmHg, P = NS; MLHF score 55 ± 23 to 25 ± 20, P = NS). Heart failure with preserved ejection fraction frequently coexists in patients with symptomatic AF and preserved ejection fraction. Restoration and maintenance of sinus rhythm in patients with comorbid AF and HFpEF improves haemodynamic parameters, BNP and symptoms associated with HFpEF.

Evaluation of Clinical outcomes of Generic versus Reference Ivabradine in Heart Failure Patients

Economic benefits associated with usage of generic drugs have been suggested to increase patients’ adherence to their medications and to improve patients’ health outcomes. However, the therapeutic equivalence of certain generic products to their branded counterparts has been questioned. Our study aims to compare the efficacy and safety of generic and branded ivabradine in adult patients with chronic heart failure with reduced ejection fraction (≤40%) (HFrEF). This was a randomized, open label, crossover, two period comparative study. A total of 32 patients with HFrEF were randomized into two groups. Group A received brand ivabradine® for 12 weeks followed by generic ivabradine for the next 12 weeks. Group B received generic ivabradine for 12 weeks followed by brand ivabradine for the next 12 weeks with no washout period. The efficacy outcomes included resting heart rate (HR), New York Heart Association Functional Classification (NYHA FC), Quality of life (QoL) using Minnesota Living with Heart Failure (MLWHF) and ejection fraction (EF). After taking the drugs for the first 12 weeks, no statistically significant difference was detected in all efficacy outcomes between Group A and Group B. After crossover and taking drugs for further 12 weeks, similar results were obtained. Only minor side effects, mainly phosphenes were observed in both products. No mortality was demonstrated in both groups. This study showed no statistically significant difference between the generic and brand ivabradine in terms of efficacy and safety. The results suggest that generic ivabradine can be a safe substitute for branded ivabradine for economic reasons.

Abstract 15762: Intensive Weight Management Improves Functional Capacity in Heart Failure With Preserved Ejection Fraction

Background: Obesity is associated with incident heart failure (HF), particularly HF with preserved ejection fraction (HFpEF). Weight loss is difficult to achieve in patients with limited physical capacity and the benefits remain uncertain in established HF. Methods: Patients with EF &gt; 50% and at least 1 objective criteria for HFpEF (BNP 200 pg/ml, elevated resting or exercise wedge pressure (15 or 25 mmHg) or pulmonary edema on CXR) and BMI 30 kg/m2 were enrolled in a 15-week weight management program that entailed weekly counseling, weight checks, and meal replacement (twice daily weeks 1-8, once daily weeks 9-12). Primary endpoints were change from baseline to 15-weeks for weight, Minnesota Living With HF (MLWHF) score and 6 minute walk (6MW). Paired t-test was used to test for differences from baseline to the 15 week clinical endpoint, and one-way ANOVA was used to evaluate if these differences persisted at 26 week follow up. Results: 65 patients signed consent, 41 completed the 15-week program and 37 had 26-week follow up. Mean age was 67±9 years, BMI 41±6 kg/m 2 , 65% were female, and 43% black. Mean weight decreased by 8.1±6.6 kg at the 15-week endpoint (p&lt;0.001) and persisted at 26-week follow up (p&lt;0.001). 74% of patients lost more than 5% of their baseline body weight at week 15. Blacks lost a mean of 6±6% body weight compared to 9±4% in Caucasians (p&lt;0.05). At 15 weeks, mean 6MW distance increased from 221±111 m to 286±99 m (p&lt;0.001) and then fell to 275±144 m at 26 weeks (p=0.043). MLWHF score improved from 60±24 to 38±27 (p&lt;0.001) and 38±26 (p&lt;0.001) at 15 and 26 weeks, respectively. BNP did not change (109 to 114 pg/ml). E/e’ decreased significantly from 13.9±6.8 to 11.9±5.6 at 26 weeks follow up (p&lt;0.01). BNP levels decreased by 39±103 pg/ml in blacks vs. an increase of 17±53 mg/dl in Caucasians (p&lt;0.05) at 15-week follow up. Conclusions: Clinically relevant weight loss is possible in patients with established HFpEF and when it occurs, this is associated with significant improvements in quality of life and exercise capacity. There may be racial differences in the biochemical response to weight management in this population.