MLHFQ Score Research Articles

Catheter ablation vs medical management for atrial fibrillation in patients with heart failure: a systematic review and metanalysis

Abstract Background Current guidelines recommend a class IIa recommendation for catheter ablation in Atrial Fibrillation [AFIB]. Traditionally, catheter ablation has been known to be more effective in maintaining sinus rhythm than pharmacological management. However, there is sparse evidence to suggest that this translates to improved clinical outcomes in patients with heart failure. We did a systematic review and meta-analysis of randomized trials to compare the efficacy of ablation vs medical management for AFIB in heart failure. Methods A systematic search was conducted for randomized trials from inception to Jan 2024 for studies comparing the outcomes of catheter ablation vs medical management for AFIB in heart failure. The primary outcome was all-cause mortality. Secondary outcomes were cardiovascular (CV) mortality, heart failure hospitalizations, change in LV ejection fraction (LVEF), AF recurrence rate, 6-minute walk test (6MWT), change in MLHFQ scores and cerebrovascular events. Random-effects models were used to calculate the pooled incidence, mean difference (MD), and risk ratios (RRs) with 95% confidence intervals (CIs). Results A total of 10 RCTs with 2,348 patients were included in this study. Pulmonary vein isolation was the mainstay ablation strategy used. Compared with medical management, Ablation was associated with a significant reduction in all-cause mortality (RR- 0.61; 95% CI, 0.48-0.78; P<0.0001). Ablation was also associated with lower cardiovascular (CV) mortality (RR- 0.52; 95% CI, 0.36-0.75; P<0.0004), heart failure hospitalizations (RR- 0.67; 95% CI, 0.54-0.82; P<0.0001) and AF recurrence rate (RR- 0.43; 95% CI, 0.25-0.75; P<0.003). The study showed an improvement in LVEF (RR - 6.05; 95% CI, 3.35-8.75; P<0.0001), 6MWT (RR- 13.99; 95% CI, 4.18-23.81; P<0.005) and in MLHFQ score (RR -6.98; 95% CI, -12.03 to -1.93; P<0.007. There was a statistically significant difference between the 2 cohorts in the rates of cerebrovascular events (RR- 0.68; 95% CI, 0.35-1.30; P<0.24). Conclusion Randomized trials have shown clear benefits with catheter ablation compared to medical management for AFIB in heart failure. Ablation has demonstrated significantly lower all-cause mortality, reduced CV mortality, HF hospitalizations, AFIB recurrence rate, and improvement in LVEF. Patients who underwent catheter ablation showed improvement in functional outcomes like 6MWT and MLHFQ scores. There was no difference in the incidence of cerebrovascular events compared to medical management. This study adds to the growing evidence in the literature for ablation therapy; however, more trials are needed to identify patients for optimal benefits across the spectrum of heart failure patients.Forest PlotsForest Plots

Patients with paradoxical low-flow, low-gradient aortic stenosis gain the least benefit from TAVI among all hemodynamic subtypes.

Substantial controversy exists regarding the clinical benefit of patients with severe paradoxical low-flow, low-gradient aortic stenosis (PLF-LG AS) from TAVI. Therefore, we compared post-TAVI benefit by long-term mortality (all-cause, CV and SCD), clinical improvement of heart failure symptoms, and cardiac reverse remodelling in guideline-defined AS subtypes. We prospectively included 250 consecutive TAVI patients. TTE, 6mwt, MLHFQ, NYHA status and NT-proBNP were recorded at baseline and 6months. Long-term mortality and causes of death were assessed. 107 individuals suffered from normal EF, high gradient AS (NEF-HG AS), 36 from low EF, high gradient AS (LEF-HG), 52 from "classic" low-flow, low-gradient AS (LEF-LG AS), and 38 from paradoxical low-flow, low-gradient AS (PLF-LG AS). TAVI lead to a significant decrease in MLHFQ score and NT-proBNP levels in all subtypes except for PLF-LG. Regarding reverse remodelling, a significant increase in EF and decrease in LVEDV was present only in subtypes with reduced baseline EF, whereas a significant decrease in LVMI and LAVI could be observed in all subtypes except for PLF-LG. During a follow-up of 3-5years, PLF-LG patients exhibited the poorest survival among all subtypes (HR 4.2, P = 0.0002 for CV mortality; HR 7.3, P = 0.004 for SCD, in comparison with NEF-HG). Importantly, PLF-LG was independently predictive for CV mortality (HR 2.9 [1.3-6.9], P = 0.009). PLF-LG patients exhibit the highest mortality (particularly CV and SCD), the poorest symptomatic benefit and the least reverse cardiac remodelling after TAVI among all subtypes. Thus, this cohort seems to gain the least benefit.

Efficacy of catheter ablation for atrial fibrillation in heart failure: a meta-analysis of randomized controlled trials.

The study aims to evaluate whether rhythm control by catheter ablation is superior to medical therapy for the patients with atrial fibrillation (AF) and heart failure (HF). The literatures were searched by using PubMed, Cochrane Library, Embase, and Web of Science databases up to 12 October 2023. The randomized controlled trials (RCTs) comparing rhythm control using catheter ablation vs. medical therapy in AF patients with HF were pooled. The primary outcomes included all-cause mortality, HF re-hospitalization, and stroke, and the secondary outcomes included left ventricular ejection fraction (LVEF), atrial tachyarrythmia recurrence, quality of life (Minnesota Living with Heart Failure Questionnaire score, MLHFQ score), 6min walking distance (6MWD), the level of N-terminal B-type natriuretic peptide precursor (NT-proBNP), and adverse events. Nine RCTs involving in 2293 patients met the inclusion criteria. Compared with medical therapy, catheter ablation reduced all-cause mortality [10.07% (121/1201) vs. 15.26% (175/1147), risk ratio (RR):0.60, 95% confidence interval (CI): 0.48-0.74, P<0.00001, I2=0%] and the rate of HF re-hospitalization (RR: 0.65, P=0.02, 95% CI: 0.45 to 0.94, I2=74%), but had no obvious difference in incidence of stroke (RR: 0.67, P=0.27, 95% CI: 0.32 to 1.38, I2=0%). Catheter ablation enhanced LVEF [mean difference (MD), 6.26%, P<0.00001, I2=89%], reduced AT recurrence (RR: 0.37, P<0.00001, 95% CI: 0.26 to 0.52, I2=89%), improved the quality of life (MLHFQ score) (MD: -6.83, P=0.003, I2=67%), elevated 6MWD (MD: 15.92, P=0.006, I2=76%), and diminished the level NT-proBNP (MD: -44.19, P<0.00001, I2=75%), but had no significant difference in adverse events [25.81% (310/1201) vs. 30.25% (347/1147), RR: 0.81, 95% CI: 0.65-1.01, P=0.06, I2=55%]. Catheter ablation as rhythm control strategy substantially enhances the survival rate, reduces HF re-hospitalization, increases the rate of sinus rhythm maintenance, improves the left ventricular function and the quality of life for AF patients with HF, and has similar safety, compared with medical therapy. The rhythm control by catheter ablation may be a better strategy for the AF patients with HF.

Catheter ablation versus medical therapy in atrial fibrillation: an umbrella review of meta-analyses of randomized clinical trials

This umbrella review synthesizes data from 17 meta-analyses investigating the comparative outcomes of catheter ablation (CA) and medical treatment (MT) for atrial fibrillation (AF). Outcomes assessed were mortality, risk of hospitalization, AF recurrence, cardiovascular events, pulmonary vein stenosis, major bleeding, and changes in left ventricular ejection fraction (LVEF) and MLHFQ score. The findings indicate that CA significantly reduces overall mortality and cardiovascular hospitalization with high strength of evidence. The risk of AF recurrence was notably lower with CA, with moderate strength of evidence. Two associations reported an increased risk of pulmonary vein stenosis and major bleeding with CA, supported by high strength of evidence. Improved LVEF and a positive change in MLHFQ were also associated with CA. Among patients with AF and heart failure, CA appears superior to MT for reducing mortality, improving LVEF, and reducing cardiovascular rehospitalizations. In nonspecific populations, CA reduced mortality and improved LVEF but had higher complication rates. Our findings suggest that CA might offer significant benefits in managing AF, particularly in patients with heart failure. However, the risk of complications, including pulmonary vein stenosis and major bleeding, is notable. Further research in understudied populations may help refine these conclusions.

Role of Telemedicine Intervention in the Treatment of Patients with Chronic Heart Failure: A Systematic Review and Meta-analysis.

Although telemedicine interventional therapy is an innovative method to reduce public medical burden and improve heart failure, its effectiveness is still controversial. This meta-analysis evaluates the role of telemedicine interventional therapy in the treatment of patients with chronic heart failure. Relevant literature on telemedicine in chronic heart failure treatment was screened and extracted based on predefined criteria. Quality assessment used Cochrane Handbook 5.1.0 tool, and meta-analysis was conducted using R 4.2.2 software. Fifteen English-language articles were ultimately included in this meta-analysis. The risk bias evaluation determined that 4 articles were low-risk bias and 11 articles were unclear risk bias. The meta-analysis revealed that, compared to the routine intervention group, the all-cause hospitalization rate of patients in the telemedicine intervention group decreased [OR = 0.63, 95% CI (0.41; 0.96), P =.03], and the hospitalization rate of heart failure also decreased [OR = 0.70, 95% CI (0.48; 0.85), P <.01]. However, there were no differences in mortality [OR = 0.64, 95% CI (0.41; 1.01), P =.05], length of hospitalization [MD = -0.42, 95% CI (-1.22; 0.38), P =.31], number of emergency hospitalizations [MD = -0.09, 95% CI (-0.33; 0.15), P =.45], medication compliance [OR = 1.67, 95% CI(0.92; 3.02), P =.09], or MLHFQ scores [MD = -2.30, 95% CI (-6.16; 1.56), P =.24] among the patients. This meta-analysis showed that telemedicine reduced overall and heart failure-related hospitalizations in chronic heart failure patients, suggesting its value in clinical management. However, it did not significantly affect mortality, hospital stay length, emergency visits, medication adherence, or quality of life. This suggests the need to optimize specific aspects of telemedicine, identify key components, and develop strategies for better treatment outcomes.

Association of Depression and Anxiety with Cardiac Structural and Functional Characteristics in Heart Failure with Reduced and Mildly Reduced Ejection Fraction.

Heart failure and mental health conditions frequently coexist and have a negative impact on health-related quality of life and prognosis. We aimed to evaluate depression and anxiety symptoms and to determine the association between psychological distress and cardiac parameters in heart failure with reduced and mildly reduced ejection fraction. A total of 43 patients (33 male, mean age 64 ± 10 years) with heart failure and left ventricular systolic dysfunction (29 with HFrEF, 14 with HFmrEF) underwent comprehensive echocardiographic evaluation. All study participants completed questionnaires for the assessment of depression (PHQ-9), anxiety (GAD-7), and health-related quality of life (MLHFQ). Ten (34%) patients with HFrEF and two (14%) participants with HFmrEF had moderate-to-severe depression symptoms. Significant anxiety symptoms were more frequent in HFrEF (10 vs. 2 patients; 34% vs. 14%). Poor quality of life was also more common among patients with HFrEF (17 vs. 5 patients; 59% vs. 36%), showing higher MLHFQ scores (p = 0.009). Moreover, PHQ-9, GAD-7, and MLHFQ scores showed significant correlations between NYHA class severity and the presence of peripheral edema. The symptoms of dyspnea correlated with both PHQ-9 and MLHFQ scores. Significant correlations were observed between MLHFQ scores and a large number of clinical features, such as exercise capacity, 6MWT distance, the need for furosemide, echocardiographic parameters (LVEDVI, LVESVI, LVEF, LVGLS, SVI), and laboratory variables (albumin, GFR, NT-proBNP). In the multiple linear regression analysis, dyspnea proved to be a significant predictor of higher PHQ-9 and MLHFQ scores, even after adjusting for potential confounders. High symptom burden due to psychological distress is common among patients with HFrEF and HFmrEF. More efficient control of congestion may improve depression, anxiety symptoms, and health-related quality of life.

Value-based health care in heart failure: Quality of life and cost analysis

ObjectivesTo measure Quality of Life (QoL) and costs of Heart Failure (HF) outpatients in Brazil as an introduction to the Value-Based Health Care (VBHC) concept. Materials and methodsCross-sectional study, patients with HF, with ejection fraction <50%, were recruited from three hospitals in Brazil. Two QoL (36-Item Short Form Survey [SF-36] and Minnesota Living with Heart Failure Questionnaire [MLHFQ]) and two anxiety/depression questionnaires were applied. SF-36 scores were stratified by domains. Treatment costs were calculated using the Time-Driven Activity-Based Costing (TDABC) method. Results were stratified by NYHA functional class and sex. ResultsFrom October 2018 to January 2021, 198 patients were recruited, and the median MLHFQ (49.5 [IQR 21.0, 69.0]) and SF-36 scores demonstrated poor QoL, worse at higher NYHA classes. A third of patients had moderate/severe depression and anxiety symptoms, and women had higher anxiety scores. Mean costs of outpatient follow-up were US$ 215 ± 238 for NYHA I patients, US$ 296 ± 399 for NYHA II and US$ 667 ± 1012 for NYHA III/IV. Lab/exam costs represented 30% of the costs in NYHA I, and 74% in NYHA III/IV (US$ 63.26 vs. US$ 491.05). ConclusionPatients with HF in Brazil have poor QoL and high treatment costs; both worsen as the NYHA classification increases. It seems that HF has a greater impact on the mental health of women. Costs increase mostly related to lab/exams. Accurate and crossed information about QoL and costs is essential to drive care and reimbursement strategies based on value.

Effects of different interventions on prognosis and quality of life in patients with atrial fibrillation.

To compare the effects of different intervention measures on prognosis and quality of life in patients with atrial fibrillation, in order to provide clinical basis for diagnosis and treatment. A total of 160 patients who visited several hospitals including Shanghai Xinhua Hospital from June 2019 to June 2021 were selected. Among them, 40 cases were in the drug treatment group (DRUG group), 40 cases in the radiofrequency ablation group (Radiofrequency ablation, RFA group), and 40 cases in the catheter ablation combined with percutaneous left atrial appendage occlusion group (""one-stop"" procedure group) and 40 cases in the percutaneous left atrial appendage closure group (Left atrial appendage closure, LAAC group). The Minnesota quality of life score (MLHFQ), ejection fraction (LVEF), and left atrial anterior and posterior diameters (LAD) were compared between the groups at 1-year follow-up, and the differences in adverse events were compared between the groups. (1) After a 1-year follow-up, overall comparison, the MLHFQ scores and the LVEF and the LAD among the four groups were statistically different (p < .01); (2) Multiple comparisons, ① the MLHFQ scores: The RFA group was the lowest, the "one-stop" operation group was lower than the DRUG group, the LAAC group was the highest (p < .01). ② LVEF: The RFA group was the highest, the "one-stop" procedure group was higher than the drug treatment group, the LAAC group was the lowest (p < .01). ③ LAD: the RFA group and the "one-stop" procedure group were smaller than the DRUG group, the DRUG group was smaller than the LAAC group (p < .01).(3) Compared with the baseline data after 1-year follow-up in each group, in the RFA group and in the "one-stop" procedure group, the MLHFQ scores was decreased, the LVEF was increased, and the LAD was decreased (p < .01); in the DRUG group: the difference was not statistically significant (p > .05); in the LAAC group, the MLHFQ scores was increased, the LVEF was decreased, and the LAD was increased (p < .01). (4) There were significant differences in the incidence of adverse events among the four groups (p < .01), the lowest in the RFA group and the highest in the LAAC group. Compared with drug treatment, radiofrequency ablation and "one-stop" procedure group can improve the quality of life of patients with atrial fibrillation, improve cardiac function, and reduce the occurrence of adverse events. Percutaneous left atrial appendage occlusion affects patients' quality of life and improves cardiac function, and increases the incidence of adverse events.

ROSS procedure versus mechanical valve replacement in young and middle-aged adults with aortic valve disease

Background: Aortic valve replacement (AVR) remains the only treatment that was revealed to advance the natural history in the cases with severe symptomatic aortic valve disorder. However, aortic valve diseases were challenging in young and adults in middle age persons. The aim of our study: was to compare the mid-term outcomes, quality of life and adverse valve- related events among patients undergoing the Ross procedure and those receiving a mechanical aortic valve . Patients and Methods: This study included patients with aortic valve disease divided into Fifty patients were candidates for ROSS procedure and the other Fifty were for mechanically aortic valve replacement after obtaining the approval of the local ethical committee. Results: Ross patients show statistically significant lower MLHFQ scores compared to Mechanical valve patients; however, a nonsignificant change was found among the study groups in terms of major cardiovascular events or mortality. Conclusion: Mechanical AVR is accompanied by low morbidities and mortalities in both the short and long term. Our data suggest that The Ross operation may be accomplished securely and reproducibly in properly particular cases with lower morbidity and mortality and better quality of life.

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

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

Clinical Study of Heart Failure with Left Ventricular Ejection Fraction Regimen Treated with Entresto.

Heart failure is a group of syndromes caused by various cardiac structural or functional disorders leading to impaired ventricular filling and (or) ejection capacity. Because of decreased ventricular systolic function and impaired ejection function, the amount of cardiac output cannot meet the body's metabolic needs; organ and tissue blood perfusion is insufficient; at the same time, pulmonary circulation and (or) systemic circulation congestion; the clinical manifestations are mainly dyspnea and weakness but restricted physical activity and edema. Treatment of the disease should include preventing and delaying the onset of wails, relieving symptoms of clinical wails, improving its long-term prognosis, and reducing mortality. The aim of the study is to observe the efficacy and safety of Entresto in the treatment of left ventricular ejection fraction heart failure (HFpEF). Seventy-eight patients with HFpEF treated in our hospital from October 2017 to April 2018 were randomized into a treatment group (Entresto 50 mg + basic treatment, n = 39) and a control group (basic treatment, n = 39). The course of treatment was ten weeks. The levels of brain natriuretic peptide (BNP) and echocardiographic indicators (LVMI, LVEF, LVEDD, LVESD, E/E′ Ratio, E/A ratio, DT), 6-minute walking test (6MWD), and Minnesota Quality of Life Scale (MLHFQ) were analyzed before and after treatment. LVMI, LVEF, LVEDD, LVESD, E/E′ ratio, E/A ratio, DT, and BNP were all significantly improved in the Entresto group after treatment. In the control group, except for LVEDD, LVESD, the E/A ratio, and BNP, other indicators were significantly improved after treatment (P < 0.05). Posttreatment, both groups had significantly improved 6MWD and MLHFQ scores (P < 0.05). Differences in these parameters between the two groups were statistically significant (P < 0.05). After treatment, the levels of NE, AngII, ALD, and MMP-9 in the two groups were decreased (P < 0.05), with the lower lever in the treatment group (P < 0.05). The effective rate was 76.92% in the control group and 94.87% in the Entresto group, and this rate difference was statistically significant (P < 0.05). The number of patients re-hospitalized due to cardiovascular events was 2 (the Entresto group) vs. 7 (the control group) cases; worsening of heart failure was observed in 1 patient (the Entresto group) vs. 6 (the control group), and the difference between the two groups was statistically significant (P < 0.05). However, the incidence of adverse reactions between the two groups was not statistically significant. Entresto can significantly improve left ventricular diastolic function in heart failure patients with preserved left ventricular ejection fraction and improve quality of life. This treatment is safe and effective and worthy of clinical application. This trail is registered with ChiCTR2000031486. This trial was approved by the Chinese Clinical Trial Registry (clinical trial number: ChiCTR2000031486). The registration number of this study is 2022-R008.

OR66. The effect of combination bisoprolol therapy with quality of life in heart failure preserved ejection fraction (HFpEF)

Abstract Background and Aims This study aimed to observe and evaluate the effect of bisoprolol in the improvement of HFpEF patient’s QoL. As we know, Global Public Health Burden of Heart Failure reported the growing prevalence of heart failure in 2020 and half of the case classified as HFpEF. It is well known that someone who have been diagnosed with heart failure will have a poorer quality of life/QoL. β-blocker is a heart rate lowering agent with a potency to improve the patient’s clinical outcome, such as QoL. Methods and Results This study is a retrospective cohort following HFpEF patients who received bisoprolol and who did not received bisoprolol. The study participant selected by purposive sampling method, who meet inclusion and exclusion criteria. This research was analysed by SPSS 25 version. It used comparasion test and regresion test to determine differences in the effects of using bisoprolol and which combination was good for lowering the MLHFQ score. The result of comparison between bisoprolol grup and non-bisoprolol grup showed a significance value of 0.000 (p &amp;lt; 0.05). Meanwhile, if bisoprolol are combined with other drugs, only the combination of 2.5 mg bisoprolol with ACE-Inhibitor has a significant effect on QoL (p total score 0.007) Conclusion We conclude that the use of bisoprolol as combination therapy is usefull for management HFpEF, because it showed improvement in the HFpEF patient’s QoL.

Abstract 10846: Gender Differences in Outcomes of Mitraclip: A Meta-Analysis

Introduction: With the approval of transcatheter mitral valve edge-edge repair (TEER) for secondary mitral regurgitation, there has been a significant increase in the volume of TEER. Prior investigators have explored gender differences in outcomes of Mitraclip (the only approved TEER) with mixed results. In this study, we systematically reviewed impact of gender on Mitraclip outcomes and performed a meta-analysis to examine short-term and long-term outcomes in women versus men. Hypothesis: Females undergoing TEER with Mitraclip will have higher mortality, major adverse events and less functional improvement compared to men. Methods: Pubmed, Google scholar, Cochrane database etc were searched through 31 May 2021 for published studies reporting outcomes with Mitraclip in women versus men. Meta-analysis was performed using comprehensive meta-analysis software using random effects model. Results: Ten studies (8 manuscripts and 2 abstracts) with total of 2924 males and 1816 females were analysed. The risk of death at discharge (p=0.71), at 30 days (p=0.32) and beyond 6-12 months (p=0.97) was similar. Acute procedural success (defined by mitral regurgitation grade ≤2 at 30 days), major adverse events at 1 month (p=0.064) and at 1 year (p= 0.98), risk of renal failure (p=0.15), stroke (p=0.71) and 1 year readmission rate (p=0.42) were all similar. Females received more blood transfusion than males (RR: 1.37, CI: 1.03-1.80, p=0.02). Prevalence of NYHA 3/4 class at 1 year post-procedure (RR: 1.36, CI: 1.19-1.56, p&lt;0.01) and MLHFQ scores (RR: 1.91, CI: 1.47-2.48, p=0.01) were higher in females compared to males. Conclusions: Females have similar early and intermediate term mortality, major adverse events and rehospitalization rates compared to men following TEER with Mitraclip. However, females have less symptoms improvement as evidenced by greater frequency of NYHA class 3/4 symptoms and higher MLHFQ scores at 6-12 months after Mitraclip implantation compared to males.

Impact of Completed Cardiac Rehabilitation Program on Depression Level in Patients with Heart Failure with Reduced Ejection Fraction

Abstract Background Heart failure (HF) is a growing chronic health condition affecting more than 20 million people worldwide. Symptoms of depression are a common co-morbidity affecting as many as 42% of patients with heart failure (HF), and are associated with a poor quality of life and adverse prognosis. Symptoms of depression have negative impacts not only on daily social and domestic activities, but also on hospitalization and mortality rates in HF patients. cardiac rehabilitation has been shown to reduce the rate of mortality, improve functional capacity, and control reduced depressive symptoms and better clinical outcomes. Objective to investigate the impact of a 12-week completed cardiac rehabilitation program on depressive symptoms in patients with heart failure with reduced ejection fraction. Patients and Methods in this prospective non-randomized study, sixty patients with stable heart failure with reduced ejection fraction with mild, moderate and sever depressive symptoms were recruited between January 2018 to June 2019 at Ain Shams University hospitals and divided into two groups Study group(n = 30); participated in 12-week cardiac rehabilitation program Control group did not participate in cardiac rehabilitation program. Cardiac rehabilitation program consisted of education, diet control, drug adherence, 12 weeks exercise sessions, Behaviors and psychosocial management, Sexual activity education Smoking cessation. All patients personally interviewed for assessment of depression and quality of life before and after study period by Beck's depression inventory –II(BDI-II) and Minnesota living with heart failure questionnaire" (MLHFQ),respectively. Also all of them underwent to echo assessment before and after study period. Result A total of 60 patients in study group were enrolled, 26 (86.7) males in both groups. there were 22 (73.3%) patients (13 with mild depressive symptoms, 5 with moderate and 4 with sever depressive symptoms) showed significant improvement in BDI-II score (P &amp;lt; 0.001), whereas 8 (26.7%) patients only did not improve significantly after exercise period, no one of the study group had been show worsening of his depressive symptoms after completed cardiac rehabilitation program. BDI-II score has significant positive correlation with MLHFQ score (r = 0.748, P &amp;lt; 0.001). In contrast, only 4 (13.3%) patients (all of them were having mild depressive symptoms) of control group improved significantly regarding depressive symptoms (P &amp;lt; 0.001), and the majority of participants 16 (53.3%) patients deteriorated regarding depressive symptoms, and the rest of group 10 (33.3%) patients didn’t show significant improvement of their depressive symptoms according to BDI-II score after study period (that was 3 months). There was a significant difference when compared BDI-II score at baseline with score after study period for CR group. The BDI-II score difference after study period also was significant between two groups (P &amp;lt; 0.001). Conclusion in conclusion, the results of this prospective, non-randomized study demonstrate that completed CR program improves depressive symptoms, quality of life and LVEF in patients with heart failure with reduced ejection fraction. Recommendation cardiac rehabilitation should be implemented in routine management of patients with heart failure to improve psychological and physical complication of HF.

Cardiac Rehabilitation Effects on Depression in Stable Heart Failure with Reduced Ejection Fraction Patients

Background: Heart failure (HF) is a growing chronic health condition affecting more than 20 million people worldwide. Symptoms of depression are a common co-morbidity affecting as many as 42% of patients with heart failure (HF) and are associated with a poor quality of life and adverse prognosis. Symptoms of depression have negative impacts not only on daily social and domestic activities, but also on hospitalization and mortality rates in HF patients. Cardiac rehabilitation has been shown to reduce the rate of mortality, improve functional capacity, and control reduced depressive symptoms and better clinical outcomes. Objective: to investigate the impact of a 12-week completed cardiac rehabilitation program on depressive symptoms in patients with heart failure with reduced ejection fraction. Patients and Methods: Sixty patients with stable heart failure with reduced ejection fraction (HFrEF) with mild, moderate and severe depressive symptoms were recruited between January 2018 to June 2019 at Ain Shams University hospitals and randomly assigned to whether or not receive a 12 weeks cardiac rehabilitation program. Cardiac rehabilitation program consisted of education, diet control, drug adherence, 12 weeks exercise sessions, behavioral and psychosocial management, and sexual activity education smoking cessation. All patients were personally interviewed for assessment of depression and quality of life before and after study period by Beck's depression inventory – II(BDI-II) and Minnesota living with heart failure questionnaire" (MLHFQ), respectively. Besides, all patients underwent echocardiographic assessment before and after study period. Result: A total of 60 patients in study group were enrolled, 26 (86.7%) males in both groups. There were 22 (73.3%) patients (13 with mild depressive symptoms, 5 with moderate and 4 with severe depressive symptoms) showed significant improvement in BDI-II score (P&lt;0.001), whereas 8 (26.7%) patients only did not improve significantly after exercise period, no patients in the study group showed worsening of his depressive symptoms after completed cardiac rehabilitation program. BDI-II score has significant positive correlation with MLHFQ score (r=0.748, P&lt;0.001). In contrast, only 4 (13.3%) patients (all of them were having mild depressive symptoms) of control group improved significantly regarding depressive symptoms (P&lt;0.001), and the majority of participants 16 (53.3%) patients deteriorated regarding depressive symptoms, and the rest of group 10 (33.3%) patients didn’t show significant improvement of their depressive symptoms according to BDI-II score after the 3 month study period. There was a significant difference when compared BDI-II score at baseline with score after study period for the cardiac rehabilitation group. The BDI-II score difference after study period also was significant between two groups (P &lt;0.001). Conclusion: The results of this study demonstrated that a complete and organized cardiac rehabilitation program improves depressive symptoms, quality of life as well as LVEF in patients with heart failure with reduced ejection fraction. Recommendation: Cardiac rehabilitation should be implemented in routine management of patients with heart failure to improve psychological and physical complication of HF. Keywords: Cardiac Rehabilitation; Depression; Heart Failure

Abstract 17469: Comparing the Effect of CRT Implantation on Quality of Life in Older Patients Compared With Younger Patients: Systematic Review and Meta-Analysis

Background: CRT had been accepted as standard of care for patients with HFrEF who qualify for the therapy. The pivotal CRT trials enrolled patients significantly younger than the typical HFrEF patients seen in the community. Benefits of CRT in older HFrEF patients is largely unknown. We sought to evaluate the change in quality of life in older patients undergoing CRT in comparison to younger patients. Hypothesis: CRT implantation is associated with comparable improvements in quality of life in younger patients (age &lt;70) and older patients (age 70 and above). Methods: PubMed, The Cochrane Library, Scopus, and Web of Science were queried for comparative effectiveness studies of CRT in older HFrEF patients. We gathered data for Quality of life measurements including improvement in NYHA class, MLHFQ, Six minute walk test. MLHFQ, Six minute walk test data was analyzed qualitatively as data was insufficient to impute Standard deviation for mean change. Changes in NYHA class was analyzed quantitatively. Random effects meta-analysis of improvement in NYHA class and relative risk (RR) is reported along with estimates of heterogeneity Results: Seven studies [n=2494 for younger group and n=1035 for older group] were included in changes in NYHA class meta-analysis. Older age group patients had similar improvement in NYHA class compared to younger age group patients. Relative risk 0.99 with 95%CI 0.93-1.06 (figure). Five studies reported Baseline and follow up MLHFQ scores for both the groups. All the five studies reported improvements in MLHFQ in both the groups. Three studies reported change in six minute walk test in meters before and after CRT implantation. All the studies reported improvement in six minute walk test both in younger and older group. Conclusions: People older than 70 years of age with heart failure with reduced ejection fraction who qualify for CRT derive similar benefits with improvement in quality of life compared to patients aged less than 70 years of age.

Cardiac contractility modulation efficacy: is there a difference between ischemic vs. non-ischemic patients?

Abstract Background/Introduction Cardiac contractility modulation (CCM) is an FDA approved device therapy for systolic heart failure patients with narrow QRS complex who are symptomatic despite optimal medical therapy. It is used in patients with a wide range of different cardiomyopathies. However, little is known whether the therapy is comparably effective in different entities. Purpose This work investigated the long-term therapeutic effect in patients with ischemic (ICMP) compared to patients with non-ischemic cardiomyopathy (NICMP). Methods 102 patients of our single center registry with known form of cardiomyopathy were included in this retrospective analysis (from 2011–2019). In 68 patients data of a clinical 3-year follow-up were available. The actual mortality rate within one and three years was compared with the one predicted by the MAGGIC risk score and compared between the two groups. In addition, changes in NYHA class, left ventricular ejection fraction (LVEF), LV end-diastolic diameter (LVEDD) and NT-proBNP values were compared as functional parameters. Results Patients with an ICMP (65%) were older (67±1 vs. 57±2 years (SD±SEM); p&amp;lt;0.001) but had a comparable MLHFQ score (42±3 vs. 48±6; p=NS), mean peak VO2 (9.7±1.2 vs. 14.5±2.2 ml/kg/min; p=NS) and QRS width (115±3 vs. 112±4 ms; p=NS). Both groups initially had a comparably advanced limitation during physical activity (median NYHA class III; p=NS); 40% of patients responded with an improvement of at least 1 NYHA class within 3 years (p=NS). The LVEF was 24±1 vs. 22±1% in the beginning and improved to 32±2 vs. 38±2% within 3 years (+33 vs. +73%; p&amp;lt;0.001 in comparison over time; p&amp;lt;0.001 in comparison of the percentage changes ICMP vs. NICMP). While LVEDD was initially significantly wider in NICMP patients (51±2 vs. 67±2 mm; p&amp;lt;0.001), this was offset under therapy, mainly due to a reduction in LVEDD in NICMP patients (+3±2 vs. −7±3 mm; p=0.023). The NT-proBNP values decreased from 4872±776 vs. 5354±1153 to 2051±578 vs. 843±363 ng/l (−58 vs. −84%; p=NS in comparison over time; p=0.093 in comparison of the percentage changes ICMP vs. NICMP). ICMP patients had a higher MAGGIC risk score (27±1 vs. 24±1; p=0.019). Mortality rates at 1 year were 7.4 vs. 17.1% and at 3 years 40.5 vs. 35.5% (each p=NS) compared to mortality rates estimated from the MAGGIC risk score of 21.2 vs. 16.0% (p=0.028) and 44.0 vs. 37.2% (p=0.071), respectively. Chi-square test for comparison of observed and expected frequencies revealed that the number of deaths during 1-year follow-up was significantly lower than predicted only in ICMP patients (p=0.018 compared to the estimated risk). Conclusions NICMP patients had a significantly greater increase in LVEF. Moreover, reverse remodeling with reduction of the LVEDD was only observed in NICMP patients. In summary, significant differences in functional therapy response could be identified between ICMP vs. NICMP patients. Funding Acknowledgement Type of funding source: None

Long-term Follow-Up of Patients with Heart Failure and Reduced Ejection Fraction Receiving Autonomic Regulation Therapy in the ANTHEM-HF Pilot Study

BackgroundThe ANTHEM-HF pilot study was an open-label study that evaluated the safety and feasibility of autonomic regulation therapy (ART) utilizing cervical vagus nerve stimulation (VNS) for patients with chronic HF with reduced EF (HFrEF). Patients in NYHA class II-III with EF ≤40% (n = 60) received ART for 6 months post-titration. ART was associated with sustained improvement in left ventricular (LV) function and HF symptoms at 6 and 12 months. MethodsContinuously cyclic VNS was maintained to determine longer-term safety and chronic effects of ART. Echocardiographic parameters and HF symptoms were assessed throughout a follow-up period of at least 42 months. ResultsBetween 12 and 42 months after initial titration, there were no device-related SAEs or malfunctions. There were 10 SAEs adjudicated to be unrelated to VNS, including 5 deaths. There were 6 non-serious adverse events that were adjudicated to be device-related (2 oropharyngeal pain, 1 implant site pain, 2 voice alteration, and 1 hoarseness). At 42 months, there was significant improvement from baseline in LVEF, NYHA class, 6-min walk distance, and MLHFQ score. However, these improvements at 42 months were not significantly different from mean values at 6 and 12 months. ConclusionsIn a 42-month follow-up, ART was durable, safe, and was associated with beneficial effects on LVEF and 6-min walk distance. Long term, chronic, open-loop ART continued to be well-tolerated in patients with HFrEF. The open label, randomized, controlled, ANTHEM-HFrEF Pivotal Study is currently underway to further evaluate ART in patients with advanced HF.

A Phase I Study of Allogeneic Mesenchymal Stem Cell Therapy in Patients with Heart Failure Secondary to Anthracycline-induced Cardiomyopathy: The Cctrn Stem Cell Injection in Cancer Survivors (Seneca) Trial

Background Anthracycline-induced cardiomyopathy (AIC) can be irreversible with a poor prognosis, and disproportionately affects women and young adults. Administration of allogeneic bone marrow-derived mesenchymal stromal cells (allo-MSCs) is a promising approach to heart failure treatment. Allo-MSCs are known to favorably affect fibrosis, apoptosis, and inflammation, which are key features of AIC. Methods This phase I study evaluated 37 adult cancer survivors (68% female) with left ventricular dysfunction secondary to chronic AIC. The study included a six-subject open-label, lead-in phase followed by 31 subjects randomized 1:1 to receive 1 × 108 allo-MSCs or vehicle via 20 transendocardial injections. Subjects were followed for 1 year to assess safety and feasibility (Fisher's test). Secondary efficacy measures included cardiac function/structure measured by magnetic resonance imaging (MRI), functional capacity, quality of life (MLHFQ), and biomarkers. These were assessed by ANCOVA adjusting for baseline values. Results Ninety-seven percent of subjects underwent successful study product injections, all allo-MSC-assigned subjects received the target dose. Follow-up visits were well attended (92%) with successful collection of endpoints in 94% at the 1-year visit. Although 58% of subjects had non-MRI compatible devices, MRI endpoints were successfully collected in 84% of subjects imaged at 1 year. No new tumors were reported. There were no significant differences between allo-MSC and vehicle groups with regard to clinical outcomes including major adverse cardiac events, other significant adverse events, and days alive and out of the hospital. Ten of the 13 efficacy measures numerically favored the allo-MSC group including a lower MLHFQ score (p = .048). Conclusion In this first-in-human study of cell therapy in patients with AIC, transendocardial administration of allo-MSCs appears safe and feasible and MRI was successfully performed in the majority of patients with devices. This study provides crucial information for designing Phase II trials aimed at assessing efficacy of cell therapy in patients with AIC.

Choir singing improves respiratory muscle strength and quality of life in patients with structural heart disease - HeartChoir: a randomised clinical trial.

Most patients with reduced exercise capacity and acquired or congenital structural heart disease also have a reduced respiratory muscle strength. The aim of this pilot study was to investigate whether choir singing in combination with respiratory muscle training positively influences respiratory muscle strength, exercise capacity and quality of life in this population. In this single-centre, randomised and open-label interventional study we compared respiratory muscle strength, exercise capacity and quality of life in patients with acquired or congenital structural heart disease who received either standard of care and a 12-week intervention (weekly choir rehearsal and daily breathing exercises) or standard of care alone. The primary endpoint was the difference in change in maximum inspiratory pressure (∆MIP%predicted). Secondary endpoints included the difference in change in maximum expiratory pressure (∆MEP%predicted), exercise capacity quantified as maximal oxygen uptake during exercise (∆MVO2%predicted) and quality of life quantified by the Minnesota living with heart failure questionnaire (∆MLHFQ score). Overall 24 patients (mean age 65, standard deviation [SD] 19 years, 46% male) were randomised after exclusion. ∆MIP%predicted was significantly higher in the intervention group (∆MIP%predicted +14, SD 21% vs &minus;14, SD 23%; p = 0.008) and quality of life improved significantly (∆MLHFQ score &minus;5, SD 6 vs 3, SD 5; p = 0.006) after 12 weeks. ∆MEP%predicted and ∆MVO2%predicted did not differ between both groups (∆MEP%predicted &minus;3, SD 26% vs &minus;3, SD 16%; p = 1.0 and ∆MVO2%predicted 18, SD 12% vs 10, SD 15%; p = 0.2). Choir singing in combination with respiratory muscle training improved respiratory muscle strength and quality of life in patients with structural heart disease and may therefore be valuable supplements in cardiac rehabilitation. (Clinical trial registration number: NCT03297918) &nbsp.