Pharmacological Restoration of mOod in HEART Failure: outcomes of the PRO-HEART trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.L Hare ◽  
D Toia ◽  
A.G Stewart ◽  
S Toukhsati

Abstract Background Depression is common in chronic heart failure (CHF) patients and is associated with increased morbidity and mortality. Anti-depressant medication has shown benefits in coronary artery disease but efficacy has not been demonstrated in CHF patients. Purpose To assess whether escitalopram is more effective than placebo in treating major and/or minor depression in patients with CHF. Methods This was a randomized, placebo-controlled, double-blind, parallel group study. Adult patients with systolic CHF (NYHA Class ≥2, nadir LVEF <40%) were screened for depression using the Cardiac Depression Scale (CDS) for a score ≥95 (sensitivity 97% at 85% specificity for major Depression (MDD)) followed by a clinical diagnosis of major or minor depression using the SCID interview. Patients were randomised to active escitalopram or matching placebo for 6 months, stratified for major or minor depression. Blinded therapy started with 5mg with automatic uptitration to 10mg after 2 weeks and further uptitration to 20mg at 2 months if CDS score remained ≥95. The primary end-point was change in CDS score over 6 months with secondary end-point change in Hamilton Depression Rating Scale (HAM-D). Results Of 28 CHF patients (males = 25; mean age = 63.61±10.32), mean CHF diagnosis 5.8 years, ischaemic aetiology (n=18), entry LVEF 42.2±9.6%; eGFR 61.8±15.4, 14 were diagnosed with major and 14 with minor depression. Two-way Mixed Model ANOVA showed a significant improvement from baseline to 6 months in both CDS (F(1,25)=18.76, p<0.001) and HAM-D (F(1,25)=17.32, p<0.001), but no significant interaction between condition and change over time. Three-way Mixed Model ANOVA showed no interaction between baseline depression diagnosis (Major or Minor) and response to treatment by condition. There were 7 SAEs for hospitalisation, unrelated to study medications and no differences between groups on AE/SAEs. Conclusions Patients showed a significant improvement in depression with both placebo and active drug but with no benefit of escitalopram over placebo. This suggests that there is no additional benefit from antidepressant therapy for CHF patients beyond that conferred by placebo. Further research is needed to explore whether greater benefits might be achieved by combination therapies or in particular subgroups of depressed CHF patients. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): National Heart Foundation of Australia, Beyond Blue

2019 ◽  
Vol 39 (2) ◽  
pp. 112-118 ◽  
Author(s):  
Osasuyi Iyasere ◽  
Edwina Brown ◽  
Fabiana Gordon ◽  
Helen Collinson ◽  
Richard Fielding ◽  
...  

Background In-center hemodialysis (HD) has been the standard treatment for older dialysis patients, but reports suggest an associated decline in physical and cognitive function. Cross-sectional data suggest that assisted peritoneal dialysis (aPD), an alternative treatment, is associated with quality of life (QoL) outcomes that are comparable to in-center HD. We compared longitudinal changes in QoL between modalities. Methods We enrolled 106 aPD patients, matched with 100 HD patients from 20 renal centers in England and Northern Ireland. Patients were assessed quarterly for 2 years using the Hospital Anxiety and Depression Scale (HADS), SF-12 physical and mental scores, symptom score, Illness Intrusiveness Rating Scale (IIRS), Barthel's score, and the Renal Treatment Satisfaction Questionnaire (RTSQ). Mixed model analysis was used to assess the impact of dialysis modality on these outcomes during follow-up. P values were adjusted for multiple significance testing. Results Multivariate analysis showed no difference in any of the outcome measures between aPD and HD. Longitudinal trends in outcomes were also not significantly different. Higher age at baseline was associated with lower IIRS and RTSQ scores during follow-up. One-hundred and twenty-five (60.6%) patients dropped out of the study: 59 (28.6%) died, 61 (29.6%) withdrew during follow-up, and 5 (2.5%) were transplanted. Conclusions Quality of life outcomes in frail older aPD patients were equivalent to those receiving in-center HD. Assisted PD is thus a valid alternative to HD for older people with end-stage kidney disease (ESKD) wishing to dialyze at home.


1998 ◽  
Vol 13 (3) ◽  
pp. 143-145 ◽  
Author(s):  
N Lauge ◽  
K Behnke ◽  
J Søgaard ◽  
B Bahr ◽  
P Bech

SummarySeveral well-known observer scales, including the Hamilton Depression Scale (HAM-D), Montgomery-Åsberg Scale (MADRS), Major Depression Rating Scale (MDS), Melancholia Scale (MES), and Inventory for Depressive Symptomatology (IDS) used for measuring severity of depressive states have been compared by their responsiveness in an open trial including patients treated with a combination of citalopram and mianserin. The patients fulfilled the Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive episode, and all scored 18 or more on the HAM-D before treatment. Onset of antidepressant action was defined as an improvement of rating scale scores of 25% or more of pre-treatment scores. A response to treatment was defined as a reduction of 50% or more on the pre-treatment scores. The results showed that the number of treatment days until improvement was 11 to 13 with no difference between the scales. The days until response were between 18 and 21 with no difference between the scales. In conclusion, the depression scales were found to be equal in their ability to detect changes in depressive symptoms during treatment. The mean of days to response was 19 for the combination of citalopram and mianserin. This is similar to the response for the combination of fluoxetine and pinolol.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Zanon ◽  
L Marcantoni ◽  
G Pastore ◽  
E Baracca ◽  
L Roncon

Abstract Background The his bundle pacing (HBP) and Left bundle branch pacing (LBBp) techniques are quickly increasing in the cardiovascular interest being the most physiological mode of pacing. Education in these new conduction system pacing (CSP) is mandatory in the modern EP programs. Achieving acceptable implant success rate, together with electrical parameters adequacy is required. Objective The aim of the study was to compare clinical and technical outcomes in 2 groups of patients, those implanted by a single operator with large expertise in CSP and those implanted by two operators (one of them during his learning curve). Methods Data from 255 consecutive patients (mean age 78±9 years; 186 males) who underwent successful HBP or LBBp implants were collected and analyzed. The operators were classified as expert after performing more than 50 procedures. Baseline caracteristics were not significantly different between the two groups. Results After a mean follow-up of 20±10months, we found that there were no differences between patients implanted by 1 single expert operator and 2 operators (1 beginner during his learning cirve supervised by 1 expert operator) in terms of clinical end point (composite of death or heart failure hospitalizations) and technical end point (need for surgical revision of the implant for reason other than battery replacement). Fluoroscopy time (16±17 min vs 9.8±11 min; p 0.004) and procedural time (113±48 min vs 16±17 min; p 0.003) were significantly prolonged when the implant was performed by 2 operators. Conclusions Skill acquisition in physiological pacing (both HBP and LBBp) is a nowadays process which cannot put patient's safety at risk. Our experience shows that clinical and technical outcomes were equivalent when the implant was performed by an expert operator or a beginner operator supervised by 1 expert operator. Fluoroscopy time and duration of the procedure were significantly prolonged by the presence of a trainees. Kaplan Meyer curves Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Gao ◽  
F Xing ◽  
D Hu ◽  
X Huang ◽  
S Hu ◽  
...  

Abstract Background Depression is prevalent among patients with heart failure (HF), but data exploring association of depression with risk of death in patients with HF is scarce in China. We investigated the relationship between depression and all-cause mortality of heart failure in China. Methods In China PEACE 5p-HF Study, we prospectively enrolled patients primarily hospitalized with HF from 52 diverse hospitals throughout China during 2016–2018. All the patients were followed up for 1 year. About 10% patients in the cohort from 41 hospitals was included for the measurement of depression state at convenience. Depression was measured by the Patient Health Questionnaire-8 depression scale (PHQ-8) at baseline. Depression state was categorized into major depressive disorder (10–24 points), minor depression (5–10 points) and no depression (0–5 points). Cox proportional hazards regression analyses, controlling for established risk factors as age, gender, LVEF, NYHA, medication use and medical history, were used to evaluate how depression were related to end point of death from any cause. Results Total 584 patients were included in our analysis, with median age 69 (IQR 60–77) years, and 40.8% female. Among these patients, 36.0% had major depressive disorder (n=210), 33.9% had minor depression (n=198). There were 70 (12%) patients died within 1 year after discharge. Major depressive disorder was associated with higher all-cause mortality compared with no depression (hazard ratio=2.18, 95% confidence interval 1.36–3.50, p=0.001). While minor depression was not significantly associated with all-cause mortality. Conclusions Major depression is an independent risk factor for all-cause mortality in hospitalized patients with HF in China. It is necessary to screen for psychological health in hospitalized patients to targeting intervention. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): National Key Research and Development Program from the Ministry of Science and Technology of China


2012 ◽  
Vol 10 (1) ◽  
pp. 141 ◽  
Author(s):  
Chantal F Ski ◽  
David R Thompson ◽  
David L Hare ◽  
Andrew G Stewart ◽  
Roger Watson

Author(s):  
Ailish Coblentz ◽  
Gavin J. B. Elias ◽  
Alexandre Boutet ◽  
Jurgen Germann ◽  
Musleh Algarni ◽  
...  

OBJECTIVEThe objective of this study was to report the authors’ experience with deep brain stimulation (DBS) of the internal globus pallidus (GPi) as a treatment for pediatric dystonia, and to elucidate substrates underlying clinical outcome using state-of-the-art neuroimaging techniques.METHODSA retrospective analysis was conducted in 11 pediatric patients (6 girls and 5 boys, mean age 12 ± 4 years) with medically refractory dystonia who underwent GPi-DBS implantation between June 2009 and September 2017. Using pre- and postoperative MRI, volumes of tissue activated were modeled and weighted by clinical outcome to identify brain regions associated with clinical outcome. Functional and structural networks associated with clinical benefits were also determined using large-scale normative data sets.RESULTSA total of 21 implanted leads were analyzed in 11 patients. The average follow-up duration was 19 ± 20 months (median 5 months). Using a 7-point clinical rating scale, 10 patients showed response to treatment, as defined by scores < 3. The mean improvement in the Burke-Fahn-Marsden Dystonia Rating Scale motor score was 40% ± 23%. The probabilistic map of efficacy showed that the voxel cluster most associated with clinical improvement was located at the posterior aspect of the GPi, comparatively posterior and superior to the coordinates of the classic GPi target. Strong functional and structural connectivity was evident between the probabilistic map and areas such as the precentral and postcentral gyri, parietooccipital cortex, and brainstem.CONCLUSIONSThis study reported on a series of pediatric patients with dystonia in whom GPi-DBS resulted in variable clinical benefit and described a clinically favorable stimulation site for this cohort, as well as its structural and functional connectivity. This information could be valuable for improving surgical planning, simplifying programming, and further informing disease pathophysiology.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G Rossitto ◽  
S Mary ◽  
C McAllister ◽  
K.B Neves ◽  
L Haddow ◽  
...  

Abstract Background Coronary and skeletal muscle microvascular dysfunction have been proposed as main factors in the pathogenesis of Heart Failure with Preserved Ejection Fraction (HFpEF). However, assessment of systemic arterial function has only been indirect thus far; most importantly, no direct link between systemic microvasculature and congestion, one of the core characteristics of the syndrome, has yet been investigated. Purpose To provide direct functional and anatomical characterisation of the systemic microvasculature and to explore in vivo parameters of capillary fluid extravasation and lymphatic clearance in HFpEF. Methods In 16 patients with HFpEF and 16 age- and sex-matched healthy controls (72±6 and 68±5 years, respectively) we determined peripheral microvascular filtration coefficient (proportional to vascular permeability and area) and isovolumetric pressure (above which lymphatic drainage cannot compensate for fluid extravasation) by venous occlusion plethysmography and collected a skin biopsy for vascular immunohistochemistry and gene expression analysis (TaqMan). Additionally, we measured brachial flow-mediated dilatation (FMD) and assessed by wire myography the vascular function of resistance arteries isolated from gluteal subcutaneous fat biopsies. Results Skin biopsies in patients with HFpEF showed rarefaction of small blood vessels (82±31 vs 112±21 vessels/mm2; p=0.003) and in ex-vivo analysis (n=6/group) we found defective relaxation of peripheral resistance arteries (p&lt;0.001). Accordingly, post-ischaemic hyperaemic response (fold-change vs baseline, 4.6±1.6 vs 6.7±1.7; p=0.002) and FMD (3.9±2.1 vs 5.6±1.5%; p=0.014) were found to be reduced in patients with HFpEF compared to controls. In the skin of patients with HFpEF we also observed a reduced number (85±27 vs 130±60 vessels/mm2; p=0.012) but larger average diameter of lymphatic vessels (42±19 vs 26±9 μm2; p=0.007) compared to control subjects. These changes were paralleled by reduced expression of LYVE1 (p&lt;0.05) and PROX1 (p&lt;0.001), key determinants of lymphatic differentiation and function. Whilst patients with HFpEF had reduced peripheral capillary fluid extravasation compared to controls (microvascular filtration coefficient, leg 33.1±13.3 vs 48.4±15.2, p&lt;0.01; trend for arm 49.9±20.5 vs 66.3±30.1, p=0.09), they had lower lymphatic clearance (isovolumetric pressure: leg 22±4 vs 16±4 mmHg, p&lt;0.005; arm 25±5 vs 17±4 mmHg, p&lt;0.001). Conclusions We provide direct evidence of systemic dysfunction and rarefaction of small blood vessels in patients with HFpEF. Despite a reduced microvascular filtration coefficient, which is in keeping with microvascular rarefaction, the clearance of extravasated fluid in HFpEF is limited by an anatomically and functionally defective lymphatic system. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): British Heart Foundation Centre of Research Excellence Award


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Calero ◽  
E Hidalgo ◽  
R Marin ◽  
L Rosenfeld ◽  
I Fernandez ◽  
...  

Abstract Background Self-care is a crucial factor in the education of patients with heart failure (HF) and directly impacts in the progression of the disease. However, little is published about its major clinical implications as admission or mortality in patients with HF. Aims and methods The aim of the study was to analyze time to admission due to acute heart failure and mortality associated with poor self-care in patients with chronic HF. We prospectively recruited consecutive patients with stable chronic HF referred to a nurse-led HF programme. Selfcare was evaluated at baseline with the 9 item European Heart Failure Self-Care Behavior Scale. Scores were standardized and reversed from 0 (worst selfcare) to 100 (better self care). For the purpose of this study we analyzed the associations of worse self-care (defined as scores below the lower tertile of the scale) with demographic, disease-related (clinical) and psychosocial factors in all patients at baseline. Results We included 1123 patients, mean age 72±11, 639 (60%) were male, mean LVEF 45±17 and 454 (40,4%) were in NYHA class III or IV. Mean score of the 9-item ESCBE was 69±28. Score below 55 (lower tertile) defined impaired selfcare behaviour. Those patients with worse self-care had more ischaemic heart disease, more COPD, and they achieved less distance in the 6 minute walking test. Regarding psychosocial items patients in lower tertile of self-care needed a caregiver more frequently, they present more cognitive impairment, depressive symptoms and worse score in terms of health self-perception. Multivariate Cox Models showed that a score below 55 points in 9-item ESCBE was independently associated with higher readmission due to acute heart failure [HR 1.26 (1.02–1.57), p value=0.034] and with mortality [HR 1.24 CI95% (1.02–1.50), p value=0.028] Conclusion Poor self-care measured with the modified 9-item ESCBE was associated with higher risk of admission due to acute decompensation and higher risk of mortality in patients with chronic heart failure. These results highlight the importance of assessing self-care and provide measures to improve them. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Hospital Univesitario de Bellvitge


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