Health-related quality of life and its associated factors among outpatients with heart failure: a cross-sectional study.

BACKGROUND: Heart Failure (HF) is a chronic disease associated with life-limiting symptoms that could negatively impact patients' health-related quality of life (HRQOL). This study aimed to evaluate HRQOL and explore the factors associated with poor HRQOL among patients with HF in Jordan. METHODS: This cross-sectional study used the validated Arabic version of the Minnesota Living with Heart Failure Questionnaire to assess HRQOL in outpatients with HF visiting cardiology clinics at two public hospitals in Jordan. Variables were collected from medical records and custom-designed questionnaires, including socio-demographics, biomedical variables, and disease and medication characteristics. Ordinal regression analysis was used to explore variables associated with poor HRQOL among HF patients. RESULTS: Ordinal regression analysis showed that the number of HF medications (P < 0.05) and not taking a loop diuretic (P < 0.05) significantly increased HRQOL, while the number of other chronic diseases (P < 0.05), stage III/IV of HF (P < 0.01), low monthly income (P < 0.05), and being unsatisfied with the prescribed medications (P < 0.05) significantly decreased HRQOL of HF patients. CONCLUSIONS: Although the current study demonstrated low HRQOL among patients with HF in Jordan, HRQOL has a considerable opportunity for improvement in those patients. Variables identified in the present study, including low monthly income, higher New York Heart Association (NYHA) classes, a higher number of comorbidities, and/or taking a loop diuretic, should be considered in future intervention programs, aiming to improve HRQOL in patients with HF.

Do the unlabeled response categories of the Minnesota Living with Heart Failure Questionnaire satisfy the monotonicity assumption of simple-summated scoring?

PURPOSE: Half of the 21-item Minnesota Living with Heart Failure Questionnaire (MLHFQ) response categories are labeled (0 = No, 1 = Very little, 5 = Very much) and half are not (2, 3, and 4). We hypothesized that the unlabeled response options would not be more likely to be chosen at some place along the scale continuum than other response options and, therefore, not satisfy the monotonicity assumption of simple-summated scoring. METHODS: We performed exploratory and confirmatory factor analyses of the MLHFQ items in a sample of 1437 adults in the Better Effectiveness After Transition-Heart Failure study. We evaluated the unlabeled response options using item characteristic curves from item response theory-graded response models for MLHFQ physical and emotional health scales. Then, we examined the impact of collapsing response options on correlations of scale scores with other variables. RESULTS: The sample was 46% female; 71% aged 65 or older; 11% Hispanic, 22% Black, 54% White, and 12% other. The unlabeled response options were rarely chosen. The standard approach to scoring and scores obtained by collapsing adjacent response categories yielded similar associations with other variables, indicating that the existing response options are problematic. CONCLUSIONS: The unlabeled MLHFQ response options do not meet the assumptions of simple-summated scoring. Further assessment of the performance of the unlabeled response options and evaluation of alternative scoring approaches is recommended. Adding labels for response options in future administrations of the MLHFQ should be considered.

Responsiveness and minimal clinically important difference of the Minnesota living with heart failure questionnaire.

BACKGROUND: The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is one of the most widely used health-related quality of life questionnaires for patients with heart failure (HF). The objective of the present study was to explore the responsiveness of the MLHFQ by estimating the minimal detectable change (MDC) and the minimal clinically important difference (MCID) in Spain. METHODS: Patients hospitalized for HF in the participating hospitals completed the MLHFQ at baseline and 6 months, plus anchor questions at 6 months. To study responsiveness, patients were classified as having "improved", remained "the same" or "worsened", using anchor questions. We used the standardized effect size (SES), and standardized response mean (SRM) to measure the magnitude of the changes scores and calculate the MDC and MCID. RESULTS: Overall, 1211 patients completed the baseline and follow-up questionnaires 6 months after discharge. The mean changes in all MLHFQ domains followed a trend (P < 0.0001) with larger gains in quality of life among patients classified as "improved", smaller gains among those classified as "the same", and losses among those classified as "worsened". The SES and SRM responsiveness parameters in the "improved" group were ≥ 0.80 on nearly all scales. Among patients classified as "worsened", effect sizes were < 0.40, while among patients classified as "the same", the values ranged from 0.24 to 0.52. The MDC ranged from 7.27 to 16.96. The MCID based on patients whose response to the anchor question was "somewhat better", ranged from 3.59 to 19.14 points. CONCLUSIONS: All of these results suggest that all domains of the MLHFQ have a good sensitivity to change in the population studied.

Confirmatory factor analysis of the Minnesota living with heart failure questionnaire among patients following open heart surgery for valve dysfunction.

INTRODUCTION: The Minnesota Living with Heart Failure Questionnaire (MLHFQ) was designed to assess the impact of the adverse effects of heart failure (HF). Numerous reports suggest an additional third factor with the proposed third factor representing a social dimension. The purpose of this study was to use confirmatory factor analysis (CFA) to validate the factor structure of the MLWHFQ, and examine a proposed third factor structure. METHODS: Participants were 1290 individuals with open heart surgery for isolated valve repair or replacement between September 2005 and May 2016. Confirmatory factor analysis was used to assess both initial and proposed alternate factor structures. RESULTS: CFA indicated a poor fit for the original proposed 2-factor solution [root mean square error of approximation (RMSEA) = 0.116], whereas separate proposed 3-factor solutions with varying item scoring fit marginally well (RMSEA = 0.080, 0.089). The CFA suggests the existence of a third dimension, social, beyond the established original two-factor solution. Results suggest in a direct comparison of proposed social dimensions, both Garin's four item solution and Munyombwe's six-item solution provide similar results. CONCLUSIONS: Results suggest support for an additional third factor among patients undergoing isolated valve replacement surgery. We suggest given the inclusion of items important to our population, relatively strong fit indices, and correlation with the SF-12, the social dimension proposed by Munyombwe best fits our population.

Validity and Reliability Studies of the Indonesian Version of the Minnesota Living with Heart Failure Questionnaire (MLHFQ): Quality of Life Questionnaire for Patients with Chronic Heart Failure.

BACKGROUND: Minnesota Living with Heart Failure Questionnaire (MLHFQ) is the most commonly used questionnaire and it has a good EMPRO (Evaluating the Measurement of Patient-Reported Outcomes) score. The MLHFQ has been adapted and used by various countries worldwide. However, to be utilized in Indonesia, it needs validity and reliability studies. This study aimed to obtain a valid and reliable Indonesian version of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) so that it can be used in Indonesia. METHODS: the present study was a cross sectional study with 85 subjects (mean age 58 (SD 11) years; 55% subjects were male) who had chronic heart failure and was treated at the outpatient clinic of cardiology in Dr. Cipto Mangunkusumo Hospital, Jakarta. Validity of the MLHFQ was assessed by evaluating the construct validity using multitrait-multimethod analysis and external validity was evaluated by compairing  the MLHFQ with the SF-36 questionnaire.  Reliability was assessed using Cronbach's α and intraclass correlation coefficients (ICC). RESULTS: the Indonesian version of the MLHFQ had moderate-to-strong correlation between domains and items in questionnaire (r: 0.571-0.748; p<0.01) and it had moderate negative correlation with SF-36 questionnaire  (r -0.595; p<0.001). The Cronbach α of Indonesian version of MLHFQ was 0.887; while the ICCs was 0.918. CONCLUSION: the Indonesian version of MLHFQ has good validity and reliability to asses the quality of life of patients with chronic heart failure in Indonesia.

Quality of life questionnaire predicts poor exercise capacity only in HFpEF and not in HFrEF.

BACKGROUND: The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is the most widely used measure of quality of life (QoL) in HF patients. This prospective study aimed to assess the relationship between QoL and exercise capacity in HF patients. METHODS: The study subjects were 118 consecutive patients with chronic HF (62 ± 10 years, 57 females, in NYHA I-III). Patients answered a MLHFQ questionnaire in the same day of complete clinical, biochemical and echocardiographic assessment. They also underwent a 5 min walk test (6-MWT), in the same day, which grouped them into; Group I: ≤ 300 m and Group II: >300 m. In addition, left ventricular (LV) ejection fraction (EF), divided them into: Group A, with preserved EF (HFpEF) and Group B with reduced EF (HFrEF). RESULTS: The mean MLHFQ total scale score was 48 (±17). The total scale, and the physical and emotional functional MLHFQ scores did not differ between HFpEF and HFpEF. Group I patients were older (p = 0.003), had higher NYHA functional class (p = 0.002), faster baseline heart rate (p = 0.006), higher prevalence of smoking (p = 0.015), higher global, physical and emotional MLHFQ scores (p < 0.001, for all), larger left atrial (LA) diameter (p = 0.001), shorter LV filling time (p = 0.027), higher E/e' ratio (0.02), shorter isovolumic relaxation time (p = 0.028), lower septal a' (p = 0.019) and s' (p = 0.023), compared to Group II. Independent predictors of 6-MWT distance for the group as a whole were increased MLHFQ total score (p = 0.005), older age (p = 0.035), and diabetes (p = 0.045), in HFpEF were total MLHFQ (p = 0.007) and diabetes (p = 0.045) but in HFrEF were only LA enlargement (p = 0.005) and age (p = 0.013. A total MLHFQ score of 48.5 had a sensitivity of 67% and specificity of 63% (AUC on ROC analysis of 72%) for limited exercise performance in HF patients. CONCLUSIONS: Quality of life, assessment by MLHFQ, is the best correlate of exercise capacity measured by 6-MWT, particularly in HFpEF patients. Despite worse ejection fraction in HFrEF, signs of raised LA pressure independently determine exercise capacity in these patients.

Pleural effusions identified by thoracic ultrasound predict poor quality of life in patients with acute decompensated heart failure.

INTRODUCTION: Pleural effusion (PE) is a common manifestation of acute decompensated heart failure (ADHF); however, its influence on the quality of life (QoL) is unknown. OBJECTIVES: To identify whether PE detected using thoracic ultrasound (TUS) is associated with poorer QoL in patients with ADHF and a reduced ejection fraction (≤40 %). METHODS: We conducted a prospective, longitudinal, descriptive, observational, single-center study at a university hospital in Mexico. We included participants with a reduced left ventricular ejection fraction who were admitted for ADHF. We performed TUS and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) within the first 48 h of hospitalization. RESULTS: Forty patients with ADHF (30 males and 10 females; mean age, 51.24 ± 16.942 years) were included in this study. The participants were categorized into two groups: those with (n = 25, 62.5 %) or without (n = 15, 37.5 %) PE on TUS. We found a statistically significant association between the presence of PEs and a worse perception of QoL. The mean MLHFQ score in the group of patients with PEs was 40 points, compared to 12 points in the group without PEs (p < 0.001). Poorer QoL was associated with a higher quantity of pleural fluid, as evidenced by the greater number of intercostal spaces occupied by the PE (p < 0.001). CONCLUSIONS: Patients with ADHF and a reduced ejection fraction who present with PE have a worse perception of QoL than patients without PE.

Cell Therapy Improves Quality-of-Life in Heart Failure: Outcomes From a Phase III Clinical Trial.

Patients with heart failure experience limitations in daily activity and poor quality-of-life. Prospective surveillance of health-related quality-of-life supplemented traditional death and hospitalization outcomes in the multinational, randomized, double-blinded CHART-1 clinical trial that assessed cardiopoiesis-guided cell therapy in ischemic heart failure patients with reduced left ventricular ejection fraction. The Minnesota Living with Heart Failure Questionnaire (MLHFQ), a Food and Drug Administration qualified instrument for evaluating therapeutic effectiveness, was applied through the 1-year follow-up. Cell treated (n = 109) and sham procedure (n = 140) cohorts reported improved MLHFQ scores comparable between the 2 study arms (mean treatment difference with baseline adjustment -3.2 points, P = .107). Superiority of cell treatment over sham in betterment of the MLHFQ score was demonstrated in patients with pre-existing advanced left ventricular enlargement (baseline-adjusted mean treatment difference -6.4 points, P = .009). In this highly responsive subpopulation, benefit on the MLHFQ score paralleled reduction in death and hospitalization post-cell therapy (adjusted Mann-Whitney odds 1.43, 95% CI, 1.01-2.01; P = .039). The potential of cell therapy in addressing the quality-of-life dimension of heart failure requires further evaluation for disease relief.

Impact of pharmacist-led pharmaceutical care on health-related and pharmaceutical therapy-related quality of life in patients with heart failure: A randomized controlled trial.

BACKGROUND: Data on the impact of pharmacist-led pharmaceutical care (PC) on pharmaceutical therapy-related and health-related quality of life (HRQoL) and their sensitivities to PC provision in patients with heart failure (HF) are scarce. OBJECTIVES: This study aimed to assess the impact of pharmacist-led PC on HRQoL employing the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and 5-level EuroQol 5 dimension (EQ-5D-5L) and on pharmaceutical therapy-related quality of life using the Patient-Reported Outcomes Measure of Pharmaceutical Therapy (PROMPT) in HF patients and compare sensitivities to the PC provision of these three tools. METHODS: A single-blinded randomized controlled trial was conducted at a tertiary public hospital in Thailand between November 2022 and May 2023. Overall, 250 patients were randomly divided into the usual care (UC) (N = 124) and PC (N = 126) groups. Mixed effects models were used to investigate the differences in the mean change scores of PROMPT, EQ-5D-5L, and MLHFQ between the UC and PC groups. The sensitivities to PC provision of the three measures were evaluated using standardized effect sizes (SESs). RESULTS: Significant differences were found in five of eight domains and the total score of the PROMPT between the PC and UC groups (all p < 0.05). However, no significant differences were found in the EQ-5D-5L and MLHFQ between the two groups (both p > 0.05). The SESs of the five domains and total score of PROMPT ranged from 0.29 to 1.65, considered small-to-large effect sizes, whereas the SESs of EQ-5D-5L and MLHFQ were -0.4 to 0, considered small effect sizes. CONCLUSIONS: Pharmacist-led PC can positively affect pharmaceutical therapy-related quality of life using PROMPT in HF patients. Additionally, PROMPT is more sensitive to PC provision than EQ-5D-5L and MLHFQ.

Minimum clinically important differences in the Minnesota Living with Heart Failure questionnaire: from a study of heart failure patients treated with integrated Chinese and Western medicine.

Objective: The purpose of this study was to estimate the minimum clinically important differences (MCIDs) in the Minnesota Living with Heart Failure questionnaire (MLHFQ), which targeted patients with heart failure treated with integrated Chinese and Western medicine, as a means of helping doctors and patients judge the effectiveness of intervention. Methods: A total of 194 patients with chronic heart failure were recruited from three general hospitals in Beijing. Anchor-based and distribution-based approaches were used to estimate MCID. The anchor was SF-36 item 2 (HT, Health Transition), and the calculation methods included the mean change method, receiver operating characteristic (ROC) curve analysis, and linear regression model. For the distribution-based approaches, 0.2, 0.5, and 0.8 standardized response mean (SRM) values and standard error of measurement (SEM) value of 1 were used. Results: The correlation coefficients of the MLHFQ scale information and HT were 0.346-0.583. Different MCIDs were obtained by the mean change method, ROC curve, and linear regression model. The minimum MCID in the physical domain, emotional domain, and total scores were 3.6, 2.0, and 7.4, respectively; the maximum estimates were 9.5, 2.5, and 13.0, respectively; and the average estimates were 5.7, 2.2, and 10.0, respectively. The average estimates were close to the result of the 0.5 SRM or 1 SEM. Conclusion: We established MCIDs in the MLHFQ using anchor-based and distribution-based approaches. It was recommended to round the average estimates of anchor-based approaches up to the nearest whole number for the MCIDs of the MLHFQ physical domain, emotional domain, and total scores. The results were 6.0, 2.0, and 10.0, respectively.

Soluble Transferrin Receptor as Iron Deficiency Biomarker: Impact on Exercise Capacity in Heart Failure Patients.

The soluble transferrin receptor (sTfR) is a marker of tissue iron status, which could indicate an increased iron demand at the tissue level. The impact of sTfR levels on functional capacity and quality of life (QoL) in non-anemic heart failure (HF) patients with otherwise normal systemic iron status has not been evaluated. We conducted an observational, prospective, cohort study of 1236 patients with chronic HF. We selected patients with normal hemoglobin levels and normal systemic iron status. Tissue iron deficiency (ID) was defined as levels of sTfR > 75th percentile (1.63 mg per L). The primary endpoints were the distance walked in the 6 min walking test (6MWT) and the overall summary score (OSS) of the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The final study cohort consisted of 215 patients. Overall QoL was significantly worse (51 ± 27 vs. 39 ± 20, p-value = 0.006, respectively), and the 6 MWT distance was significantly worse in patients with tissue ID when compared to patients without tissue ID (206 ± 179 m vs. 314 ± 155, p-value < 0.0001, respectively). Higher sTfR levels, indicating increased iron demand, were associated with a shorter distance in the 6 MWT (standardized ß = -0.249, p < 0.001) and a higher MLHFQ OSS (standardized ß = 0.183, p-value = 0.008). In this study, we show that in patients with normal systemic iron parameters, higher levels of sTfR are strongly associated with an impaired submaximal exercise capacity and with worse QoL.

Self-Reported Physical Activity, QoL, Cardiac Function, and Cardiorespiratory Fitness in Women With HER2+ Breast Cancer.

Background: Women treated for breast cancer are at risk for worsening health-related quality of life (QoL), cardiac function, and cardiorespiratory fitness. Objectives: The aim of this study was to assess the associations of self-reported moderate to vigorous intensity physical activity (MVPA) during cancer treatment with concurrent measures of QoL and cardiac function and with post-treatment cardiorespiratory fitness in women with human epidermal growth factor receptor 2-positive breast cancer receiving sequential anthracyclines and trastuzumab. Methods: EMBRACE-MRI 1 (Evaluation of Myocardial Changes During Breast Adenocarcinoma Therapy to Detect Cardiotoxicity Earlier With MRI) study participants who completed questionnaires for MVPA (modified Godin Leisure Time Physical Activity Questionnaire) and QoL (EQ-5D-3L, Minnesota Living With Heart Failure Questionnaire) and cardiac imaging every 3 months during treatment and post-treatment cardiopulmonary exercise testing were included. Participants engaging in ≥90 minutes of MVPA each week were labeled "active." Generalized estimation equations and linear regression analyses were used to assess concurrent and post-treatment associations with MVPA and activity status, respectively. Results: Eighty-eight participants were included (mean age 51.4 ± 8.9 years). Mean MVPA minutes, QoL, and cardiac function (left ventricular ejection fraction, global longitudinal strain, E/A ratio, and E/e' ratio) worsened by 6 months into trastuzumab therapy. Higher MVPA (per 30 minutes) during treatment was associated with better concurrent overall (ß = -0.42) and physical (ß = -0.24) Minnesota Living With Heart Failure Questionnaire scores, EQ-5D-3L index (ß = 0.003), visual analogue scale score (ß = 0.43), diastolic function (E/A ratio; ß = 0.01), and global longitudinal strain (ß = 0.04) at each time point (P ≤ 0.01 for all). Greater cumulative MVPA over the treatment period was associated with higher post-treatment cardiorespiratory fitness (peak oxygen consumption; ß = 0.06 per 30 minutes; P < 0.001). Conclusions: Higher self-reported MVPA during treatment for human epidermal growth factor receptor 2-positive breast cancer was associated with better QoL and diastolic and systolic left ventricular function measures during treatment and better post-treatment cardiorespiratory fitness.

Health-Related Quality of Life and Associated Factors Among Adult Patients with Heart Failure in Wolaita Zone Governmental Hospitals, Southern Ethiopia.

BACKGROUND: Knowing how heart failure affects patients' quality of life and its associated factors are crucial for a better patient-centred approach and management. Therefore, this study aims to assess health-related quality of life and its associated factors among adult heart failure patients in southern Ethiopia hospitals. METHODS: The facility-based cross-sectional study design was conducted in Wolaita zone governmental hospitals from March to April 2018. The population was all adult heart failure patients in the chronic illness follow-up clinic and inpatient department. All adult heart failure patients on follow-up clinic and inpatient departments who have at least a 6-month follow-up were included in the study. In contrast, patients who had chronic comorbidities were excluded from the study. Minnesota Living with Heart Failure Questionnaire (MLHFQ) tool was used to measure the outcome variable health-related quality of life (HRQoL). Interviews and client medical record reviews also collected socio-demographic, clinical and behavioural characteristics of participants. The data were analyzed using STATA version 14, and multiple linear regression analysis with P-value < 0.05 was used to measure the degree of association between HRQoL and independent variables. RESULTS: A total of 372 patients participated in the study. The HRQoL score for the physical, emotional, and total were 22.2, 7.7, and 46.37, respectively. HRQoL was significantly associated with gender, age, family size, occupation, residency, and recent admission within the past six months, New York Heart Association (NYHA) functional class, department of treatment, salt intake, and health perception. CONCLUSION: Generally, the HRQoL for patients with heart failure was found to be low. Besides the variables age and gender of participants, family size, occupation, residency, admission history, salt intake, and NYHA class were significant factors for the HRQoL of patients with heart failure.

Validation and Psychometric Properties of the Minnesota Living With Heart Failure Questionnaire in Individuals With Coronary Artery Disease in Lithuania.

BACKGROUND: Health-related quality of life (HRQoL) is known to be impaired in individuals with coronary artery disease (CAD), especially in those after a recent acute coronary syndrome (ACS). Heart failure (HF) is a common burden in this population that significantly contributes to worsening HRQoL. To accurately measure the level of HRQoL in individuals with CAD after ACS, disease-specific scales, such as the Minnesota living with heart failure questionnaire (MLHFQ), are recommended. Nevertheless, to date, there has not been a study that would comprehensively evaluate the psychometric properties of the MLHFQ in a large sample of individuals with CAD after ACS. The debate regarding the internal structure of MLHFQ is also still present. Hence, this study aimed to translate the MLHFQ and evaluate its internal structure, reliability/precision, and validity in individuals with CAD following ACS in Lithuania. METHODS: In the cross-sectional study, 1,083 participants (70% men, age M = 58, SD = 9) were evaluated for sociodemographic and clinical characteristics. HRQoL was measured using the MLHFQ and the Short Form-36 health survey (SF-36). In addition, exercise capacity (EC) was also evaluated in the study patients, using a standardized computer-driven bicycle ergometer. RESULTS: The internal consistency of the MLHFQ subscales (0.79-0.88) was found to be good. Confirmatory factor analysis (CFA) provided the support for the three-factor model ("physical domain," "social domain," and "emotional domain") of the MLHFQ and showed acceptable fit [comparative fit indices (CFI) = 0.894; goodness-of-fit (GFI) = 0.898; non-normal fit index (NFI) = 0.879, and root mean square error of approximation (RMSEA) = 0.073]. Regarding convergent evidence, significant associations were found between the MLHFQ domains and the SF-36 domains and EC (r's range 0.11-0.58). CONCLUSION: The current study completed cultural validation and provided further information on the psychometric characteristics of the MLHFQ in Lithuania, suggesting MLHFQ as a valid and reliable instrument to measure HRQoL. The Lithuanian version of MLHFQ is best described by a three-factor solution, measuring physical, social, and emotional dimensions of HRQoL among individuals with CAD following ACS.

Correlation between medication regimen complexity and quality of life in patients with heart failure.

PURPOSE: To determine if a correlation exists between the medication regimen complexity index (MRCI) and quality of life (QoL) in patients with heart failure (HF) assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). METHODS: Retrospective chart review from July 2012 through June 2018 identified patients for inclusion who completed an MLHFQ. Baseline and, if available, follow-up MLHFQ scores were collected. The medication list documented on the date of the MLHFQ was used to calculate the MRCI. RESULTS: Patients with a documented MLHFQ score were included (n = 72) in the primary analysis. No correlation existed between baseline MRCI and MLHFQ (r = 0.07; p = 0.55). A secondary analysis of correlation between change in MRCI and MLHFQ was conducted for patients (n = 30) with a follow-up MLHFQ score. A moderate, negative correlation (r = -0.47; p = 0.009) existed between change in MRCI and MLHFQ from baseline to follow-up. CONCLUSION: No significant correlation between MRCI and MLHFQ scores were found at baseline. Patients with follow-up MLHFQ scores demonstrated improvements in QoL, despite increasingly complex medication regimens. Medication regimen complexity alone is likely an insufficient marker for predicting QoL in patients with HF.

A comprehensive individual patient data meta-analysis of the effects of cardiac contractility modulation on functional capacity and heart failure-related quality of life.

AIMS: Cardiac contractility modulation, also referred to as CCM™, has emerged as a promising device treatment for heart failure (HF) in patients not indicated for cardiac resynchronization therapy. We performed a comprehensive individual patient data meta-analysis of all non-confounded prospective randomized controlled trials of CCM vs. control that have measured functional capacity and/or quality of life questionnaires in patients with HF. METHODS AND RESULTS: The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched in January 2020 to identify eligible randomized controlled trials. We also asked the sole manufacturer of the device for their list of known trials. Primary outcomes of interest were peak oxygen consumption (peak VO2 ), 6 min walk test distance, and quality of life measured by Minnesota Living with Heart Failure Questionnaire (MLWHFQ), and all data were received as individual patient and individual time point data-points. Mean differences and 95% confidence intervals (CIs) were calculated for continuous data using a fixed-effects model. Five trials were identified, four randomized studies enrolling 801 participants for all endpoints of interest, and for peak VO2 alone (n = 60), there was an additional single arm non-randomized trial (FIX-HF-5C2) with a prospective comparison of its 24 week peak VO2 data compared with the control group of the FIX-HF-5C control patients. Pooled analysis showed that, compared with control, CCM significantly improved peak VO2 (mean difference +0.93, 95% CI 0.56 to 1.30 mL/kg/min, P < 0.00001), 6 min walk test distance (mean difference +17.97, 95% CI 5.48 to 30.46 m, P = 0.005), and quality of life measured by MLWHFQ (mean difference -7.85, 95% CI -10.76 to -4.94, P < 0.00001). As a sensitivity analysis, we excluded the FIX-HF-5C2 trial (only relevant for peak VO2 ), and the result was similar, mean difference +0.65, 95% CI 0.21 to 1.08 mL/kg/min, P = 0.004. CONCLUSIONS: This comprehensive meta-analysis of individual patient data from all known randomized trials has shown that CCM provides statistically significant and clinically meaningful benefits in measures of functional capacity and HF-related quality of life.

Determinants of Functional Capacity and Quality of Life After Implantation of a Durable Left Ventricular Assist Device.

Continuous-flow left ventricular assist devices (LVAD) are increasingly used as destination therapy in patients with end-stage heart failure and, with recent improvements in pump design, adverse event rates are decreasing. Implanted patients experience improved survival, quality of life (QoL) and functional capacity (FC). However, improvement in FC and QoL after implantation is not unequivocal, and this has implications for patient selection and preimplantation discussions with patients and relatives. This article identifies preimplantation predictors of lack of improvement in FC and QoL after continuous-flow LVAD implantation and discusses potential mechanisms, allowing for the identification of potential factors that can be modified. In particular, the pathophysiology behind insufficient improvement in peak oxygen uptake is discussed. Data are included from 40 studies, resulting in analysis of >700 exercise tests. Mean peak oxygen uptake was 13.4 ml/kg/min (equivalent to 48% of predicted value; 259 days after implantation, range 31-1,017 days) and mean 6-minute walk test distance was 370 m (182 days after implantation, range 43-543 days). Finally, the interplay between improvement in FC and QoL is discussed.

Cardiac contractility modulation improves long-term survival and hospitalizations in heart failure with reduced ejection fraction.

AIMS: Cardiac contractility modulation (CCM) improves symptoms and exercise tolerance and reduces heart failure (HF) hospitalizations over 6-month follow-up in patients with New York Heart Association (NYHA) class III or IV symptoms, QRS < 130 ms and 25% ≤ left ventricular ejection fraction (LVEF) ≤ 45% (FIX-HF-5C study). The current prospective registry study (CCM-REG) aimed to assess the longer-term impact of CCM on hospitalizations and mortality in real-world experience in this same population. METHODS AND RESULTS: A total of 140 patients with 25% ≤ LVEF ≤ 45% receiving CCM therapy (CCM-REG25-45 ) for clinical indications were included. Cardiovascular and HF hospitalizations, Minnesota Living with Heart Failure Questionnaire (MLHFQ) and NYHA class were assessed over 2 years. Mortality was tracked through 3 years and compared with predictions by the Seattle Heart Failure Model (SHFM). A separate analysis was performed on patients with 35% ≤ LVEF ≤ 45% (CCM-REG35-45 ) and 25% ≤ LVEF < 35% (CCM-REG25-34 ). Hospitalizations decreased by 75% (from 1.2/patient-year the year before, to 0.35/patient-year during the 2 years following CCM, P < 0.0001) in CCM-REG25-45 and by a similar amount in CCM-REG35-45 (P < 0.0001) and CCM-REG25-34 . MLHFQ and NYHA class improved in all three cohorts, with progressive improvements over time (P < 0.002). Three-year survival in CCM-REG25-45 (82.8%) and CCM-REG24-34 (79.4%) were similar to those predicted by SHFM (76.7%, P = 0.16; 78.0%, P = 0.81, respectively) and was better than predicted in CCM-REG35-45 (88.0% vs. 74.7%, P = 0.046). CONCLUSION: In real-world experience, CCM produces results similar to those of previous studies in subjects with 25% ≤ LVEF ≤ 45% and QRS < 130 ms; cardiovascular and HF hospitalizations are reduced and MLHFQ and NYHA class are improved. Overall mortality was comparable to that predicted by the SHFM but was lower than predicted in patients with 35% ≤ LVEF ≤ 45%.

Assessing health-related quality of life in heart failure patients attending an outpatient clinic: a pragmatic approach.

AIMS: Improving quality of life (QoL) in heart failure patients is a key management objective. Validated health-related QoL (HR-QoL) measurement tools have been incorporated into clinical trials but not routinely into daily practice. The aims of this study were to investigate the acceptability and feasibility of implementing validated HR-QoL instruments into heart failure clinics and to examine the impact of patient characteristics on HR-QoL. METHODS AND RESULTS: One hundred and sixty-three patients attending heart failure clinics at a UK tertiary centre were invited to complete three HR-QoL assessments: the Minnesota Living with Heart Failure Questionnaire (MLHFQ); the EuroQoL 5D-3L (EQ-5D-3L); and the Kansas City Cardiomyopathy Questionnaire (KCCQ) in that order. Data on patient demographics, co-morbidities, New York Heart Association (NYHA) class, plasma B-type natriuretic peptide (BNP), renal function, and left ventricular ejection fraction were recorded. 94% of patients attending clinic were willing to participate. The EQ-5D-3L had all questions answered by 92% of patients, compared with 86% and 51% for the MLHFQ and KCCQ, respectively. HR-QoL significantly correlated with NYHA class using each tool (MLHFQ, r = 0.59; KCCQ, r = -0.61; EQ-5D-3L, r = -0.44, all P < 0.01). However, within each NYHA class, there was a widespread of HR-QoL scores. There was no association between patient demographics, left ventricular ejection fraction, plasma B-type natriuretic peptide, or renal function with HR-QoL using any tool. CONCLUSIONS: Health-related QoL assessment by validated questionnaire was acceptable to patients and feasible to perform in routine practice. Although NYHA class correlated significantly with HR-QoL scores, there was high variability in HR-QoL within each NYHA class, highlighting its limitation as the sole assessment of HR-QoL. Clinicians should encourage the assessment of HR-QoL to facilitate patient-centred care and make more specific use of HR-QoL measurement tools.

First-in-Man Study of a Cardiac Extracellular Matrix Hydrogel in Early and Late Myocardial Infarction Patients.

This study evaluated the safety and feasibility of transendocardial injections of VentriGel, a cardiac extracellular matrix hydrogel, in early and late post-myocardial infarction (MI) patients with left ventricular (LV) dysfunction. VentriGel was delivered in 15 patients with moderate LV dysfunction (25% ≤ LV ejection fraction ≤ 45%) who were between 60 days to 3 years post-MI and were revascularized by percutaneous coronary intervention. The primary endpoints were incidence of adverse events and abnormal clinical laboratory results. This first-in-man study established the safety and feasibility of delivering VentriGel in post-MI patients, thus warranting further evaluation in larger, randomized clinical trials.