Search

BackgroundCardiac resynchronization therapy (CRT) improves symptoms, health-related quality of life and long-term survival in patients with systolic heart failure (HF) and shortens QRS duration. However, up to one third of patients attain no measurable clinical benefit from CRT. An important determinant of clinical response is optimal choice in left ventricular (LV) pacing site. Observational data have shown that achieving an LV lead position at a site of late electrical activation is associated with better clinical and echocardiographic outcomes compared to standard placement, but mapping-guided LV lead placement towards the site of latest electrical activation has never been investigated in a randomized controlled trial (RCT). The purpose of this study was to evaluate the effect of targeted positioning of the LV lead towards the latest electrically activated area. We hypothesize that this strategy is superior to standard LV lead placement.MethodsThe DANISH-CRT trial is a national, double-blinded RCT (ClinicalTrials.gov NCT03280862). A total of 1000 patients referred for a de novo CRT implantation or an upgrade to CRT from right ventricular pacing will be randomized 1:1 to receive conventional LV lead positioning preferably in a non-apical posterolateral branch of the coronary sinus (CS) (control group) or targeted positioning of the LV lead to the CS branch with the latest local electrical LV activation (intervention group). In the intervention group, late activation will be determined using electrical mapping of the CS. The primary endpoint is a composite of death and non-planned HF hospitalization. Patients are followed for a minimum of two years and until 264 primary endpoints occurred. Analyses will be conducted according to the intention-to-treat principle. Enrollment for this trial began in March 2018, and per April 2023, a total of 823 patients have been included. Enrollment is expected to be complete by mid-2024.ConclusionsThe DANISH-CRT trial will clarify whether mapping-guided positioning of the LV lead according to the latest local electrical activation in the CS is beneficial for patients in terms of reducing the composite endpoint of death or non-planned hospitalization for heart failure. Results from this trial are expected to impact future guidelines on CRT. Background: Cardiac resynchronization therapy (CRT) improves symptoms, health-related quality of life and long-term survival in patients with systolic heart failure (HF) and shortens QRS duration. However, up to one third of patients attain no measurable clinical benefit from CRT. An important determinant of clinical response is optimal choice in left ventricular (LV) pacing site. Observational data have shown that achieving an LV lead position at a site of late electrical activation is associated with better clinical and echocardiographic outcomes compared to standard placement, but mapping-guided LV lead placement towards the site of latest electrical activation has never been investigated in a randomized controlled trial (RCT). The purpose of this study was to evaluate the effect of targeted positioning of the LV lead towards the latest electrically activated area. We hypothesize that this strategy is superior to standard LV lead placement. Methods: The DANISH-CRT trial is a national, double-blinded RCT (ClinicalTrials.gov NCT03280862). A total of 1,000 patients referred for a de novo CRT implantation or an upgrade to CRT from right ventricular pacing will be randomized 1:1 to receive conventional LV lead positioning preferably in a nonapical posterolateral branch of the coronary sinus (CS) (control group) or targeted positioning of the LV lead to the CS branch with the latest local electrical LV activation (intervention group). In the intervention group, late activation will be determined using electrical mapping of the CS. The primary endpoint is a composite of death and nonplanned HF hospitalization. Patients are followed for a minimum of 2 years and until 264 primary endpoints occurred. Analyses will be conducted according to the intention-to-treat principle. Enrollment for this trial began in March 2018, and per April 2023, a total of 823 patients have been included. Enrollment is expected to be complete by mid-2024. Conclusions: The DANISH-CRT trial will clarify whether mapping-guided positioning of the LV lead according to the latest local electrical activation in the CS is beneficial for patients in terms of reducing the composite endpoint of death or nonplanned hospitalization for heart failure. Results from this trial are expected to impact future guidelines on CRT. ClinicalTrials.gov identifier: NCT03280862.

© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved., A key factor to successful secondary prevention of cardiovascular disease (CVD) is optimal patient adherence to treatment. However, unsatisfactory rates of adherence to treatment for CVD risk factors and CVD have been observed consistently over the last few decades. Hence, achieving optimal adherence to lifestyle measures and guideline-directed medical therapy in secondary prevention and rehabilitation is a great challenge to many healthcare professionals. Therefore, in this European Association of Preventive Cardiology clinical consensus document, a modern reappraisal of the adherence to optimal treatment is provided, together with simple, practical, and feasible suggestions to achieve this goal in the clinical setting, focusing on evidence-based concepts.

Aim The aim of this study was to evaluate if a combination of World Health Organization-5 (WHO-5), Anxiety Symptom Scale-2 (ASS-2) and Major Depression Inventory-2 (MDI-2) can replace the Hospital Anxiety and Depression Scale (HADS) as screening tool for anxiety and depression in cardiac patients across diagnoses, and whether it is feasible to generate crosswalks (translation tables) for use in clinical practice. Methods We used data from the Danish ‘Life with a heart disease’ survey, in which 10,000 patients with a hospital contact and discharge diagnosis of ischemic heart disease (IHD), heart failure (HF), heart valve disease (HVD) or atrial fibrillation (AF) in 2018 were invited. Potential participants received an electronic questionnaire including 51 questions on health, well-being, and evaluation of the health care system. Crosswalks between WHO-5/ASS-2 and HADS-A, and between WHO-5/MDI-2 and HADS-D were generated and tested using item response theory (IRT). Results A total of 4346 patients responded to HADS, WHO-5, ASS-2, and MDI-2. Model fit of the bi-factor IRT models illustrated appropriateness of a bi-factor structure and thus of essential uni-dimensionality (RMSEA(p value) range 0.000-0.053(0.0099-0.7529) for anxiety, and 0.033-0.061(0.0168-0.2233) for depression). A combination of WHO-5 and ASS-2 measured the same trait as HADS-A, and a combination of WHO-5 and MDI-2 measured the same trait as HADS-D. Consequently, crosswalks (translation tables) were generated. Conclusions Our study shows that it is feasible to use crosswalks between HADS-A and WHO-5/ASS-2, and HADS-D and WHO-5/MDI-2 for screening cardiac patients across diagnoses for anxiety and depression in clinical practice.

Objective: Depression and anxiety in patients with an implantable cardioverter-defibrillator (ICD) are associated with adverse outcomes. This study describes the design of the PSYCHE-ICD study and evaluates the correlation between cardiac status and depression and anxiety in ICD patients. Methods: We included 178 patients. Prior to implantation, patients completed validated psychological questionnaires for depression, anxiety and personality traits. Cardiac status was evaluated by means of left ventricular ejection fraction assessment (LVEF), New York Heart Association (NYHA) functional class, 6-minute walk test (6MWT), and 24-h Holter monitoring for heart rate variability (HRV). A cross-sectional analysis was performed. Follow-up with annual study visits, including repeated full cardiac evaluation, will continue 36 months after ICD implantation. Results: Depressive symptoms were present in 62 (35%) and anxiety in 56 (32%) patients. Values of depression and anxiety significantly increased with higher NYHA class (P < 0.001). Depression symptoms were correlated with a reduced 6MWT (411 ± 128 vs. 488 ± 89, P < 0.001), higher heart rate (74 ± 13 vs. 70 ± 13, P = 0.02), higher thyroid stimulation hormone levels (1.8 [1.3–2.8] vs 1.5 [1.0–2.2], P = 0.03) and multiple HRV parameters. Anxiety symptoms were correlated with higher NYHA class and a reduced 6MWT (433 ± 112 vs 477 ± 102, P = 0.02). Conclusion: A substantial part of patients receiving an ICD have symptoms of depression and anxiety at time of ICD implantation. Depression and anxiety were correlated with multiple cardiac parameters, suggesting a possible biological links between psychological distress and cardiac disease in ICD patients.

Aim: To investigate the effect of screening for anxiety and depression (AD) in patients with ischaemic heart disease (IHD) on the likelihood of receiving treatment for AD. Methods: We used a nationwide dataset of all Danish patients with an incident IHD diagnosis in the period 2015–2018 ( N = 80,701) of which 20,461 (25%) were exposed to screening for AD as part of cardiac rehabilitation. A binary composite indicator for the use of any AD treatment (prescriptions of AD drugs, general practitioner (GP) counselling or referral to a psychologist), was modelled as the dependent variable. The probability of receiving AD treatment was estimated using linear probability and instrumental variable regression models. Results: Exposure to AD screening was lower for patients with low income (change in probability −0.67, 95% CI −0.76; −0.59), low education (change in probability −0.16, 95% CI −0.20; −0.13), and a high comorbidity burden (change in probability −0.09, 95% CI −0.10; −0.07). Screened patients had a lower conditional probability of AD treatment (change in probability −0.0061, p < 0.001) than non-screened patients. The patient’s GP also had an impact on the probability of being referred for AD treatment. Using an instrumental variable approach did not affect the results. Conclusions: Screening for AD was subject to selection at the patient level; patients at lower risk of AD had a higher probability of being screened. Hence, extending systematic screening to cover a larger population may not achieve a noticeable increase in the uptake of AD treatment if it is not supported by appropriate measures to reduce reverse selection into screening.

Objectives Use of Motivational Interviewing (MI) in education may improve medication-overuse headache (MOH) patients’ ability to cope with pain. In a randomised controlled trial, we evaluated the effect of education focusing on behavioural change among MOH patients. Methods Ninety-eight MOH patients were randomized (1:1) to standard treatment and 12-weeks of MI-based education versus standard treatment alone after detoxification. Outcome of interest was changes in coping strategies measured by the Coping Strategy Questionnaire at four- and nine months. Results The educational program improved patients’ perceived efficacy in the use of their coping strategies to control pain, both at four-and nine months follow-up (mean±SE): ∆:0.84 ± 0.35, 95% CI:0.16;1.52, p = 0.02 and: ∆: 0.90 ± 0.39, 95% CI:0.14;1.66, p = 0.02, respectively. No between-group differences were detected in the other coping subscales. Within the intervention group, the coping strategy subscales Catastrophizing, and Reinterpretation of pain sensation were significantly improved at nine months follow-up (p = 0.003 vs. p = 0.012, respectively). No changes were found in the control group. Conclusion MI-based education focused on behavioural changes improved MOH patients’ perceived efficacy in the use of their coping strategies to control pain. Practice implications Education based on MI could be valuable for MOH patients with respect to behavioural changes and perceived headache control.

OBJECTIVE: Identify implantable cardioverter defibrillator (ICD) patients at risk of distress (i.e., depression, anxiety, and ICD concerns) and associated risk factors.METHOD: First-time ICD patients (n = 1503) from the Danish national DEFIB-WOMEN study completed questionnaires at baseline, 3, 6, 12 and 24 months.RESULTS: Of patients with low scores on distress, only 4%-7.2% experienced an increase in distress during 24 months of follow-up (FU), while 30.5%-52.5% with increased levels were likely to maintain increased levels at FU. Higher education, higher age, female sex, and good physical functioning at baseline were associated with less depression, anxiety and ICD concerns at FU. Previous psychological problems, smoking, Type D personality, NYHA class III-IV - all assessed at baseline - and shocks during FU were associated with depression, anxiety and ICD concerns.CONCLUSIONS: Generally, patients' psychological health improved, but patients with increased baseline scores were more likely to have increased scores at FU. We need to be vigilant if patients report elevated distress, particularly if they have depression at baseline, as depression seems more persistent. Given the impact of depression on health-related quality of life and prognosis, they should be screened and monitored closely.

How to enable more widespread sustainable food choice and diets is an unresolved challenge. A consumer-friendly sustainability labelling scheme 'holistically' encompassing all sustainability aspects 'in one' might be a way forward, but this idea entails both opportunities and challenges, not least given that this requires a common understanding of what sustainability is, and which sustainability dimensions need to be communicated. We address this global problem through qualitative expert elicitation, interviewing sustainability and labelling experts from academia, think tanks and non-governmental organisations, food producers, the retail sector, and governmental bodies about the steps to consider and the challenges and opportunities entailed. Our findings reveal mixed arguments for and against a holistic sustainability label. Experts suggest that consumers and food sector stakeholders appear to be 'ready' for and perceive such a label as a desirable tool. Nevertheless, unanticipated consequences could potentially hamper its impact, and challenges are the complexity of the issue, the lack of data, and that it is unlikely sector stakeholders can agree. We conclude that the most important aspects to improve effectiveness are the information content allowing to compare to alternatives, a consistent application on all products through mandatory labelling, and coupling implementation of a label within a broader supportive policy mix. We discuss four different policy scenarios that each show how the opportunities and challenges can play out in different potential routes from here. (C) 2021 Institution of Chemical Engineers. Published by Elsevier B.V. All rights reserved.

OBJECTIVE: To examine the cumulative incidence of and covariates' association with new onset anxiety and depression in implantable cardioverter defibrillator (ICD) patients during 24 months of follow-up in patients without depression and anxiety at implant.METHODS: Patients (n = 1040; 155 (14.9%) women; mean age: 64.2 ± 10.6) with a first-time ICD enrolled in the national, multi-center prospective observational DEFIB-WOMEN study comprised the study cohort. We obtained information on demographic and clinical data from the Danish Pacemaker and ICD Register.RESULTS: During 24 months of follow-up, 138 (14.5%) patients developed new onset anxiety and 109 (11.3%) new onset depression. Age ≥ 60 [HR:0.60;95%CI:0.40-0.90] and an anxiety score between 3 and 4 [HR:2.85; 95%CI:1.71-4.75] and 5-7 [HR:5.97; 95%CI:3.77-9.45] on the Hospital Anxiety and Depression Scale (HADS) were associated with different hazards of new onset anxiety during follow-up. Age ≥ 60 [HR:0.62;95%CI:0.42-0.93] and a HADS depression score between 3 and 4 [HR:2.99;95%CI:1.80-4.95] and 5-7 [HR:6.45; 95%CI:4.12-10.10] were associated with different hazards of new onset depression.CONCLUSION: During 24 months of follow-up, respectively 14.5% and 11.3% of patients developed new onset anxiety and depression, suggesting that screening patients at several timepoints, and in particular those with even minimally elevated HADS scores at baseline, may be warranted to identify patients at risk for poor health outcomes.

Introduction Remote patient monitoring (RPM) of heart failure patients has the potential to reduce healthcare resource use and costs, but current evidence has been inconclusive. This study aims assess the impact of RPM of heart failure patients with an implantable cardioverter defibrillator on medical resource use, direct medical costs, quality-adjusted life years (QALYs), and travel time of patients, and to estimate its commercial headroom in the Netherlands and Germany. Methods Data from the REMOTE-CIED randomized controlled trial were used to calculate differences in length of hospital stay, outpatient clinic visits, telephone consults, emergency room visits, and travel time between patients on in-clinic follow-up and RPM in the Netherlands, Germany, and France. Incremental cardiac-related healthcare costs and QALYs were calculated and used to calculate the commercial headroom of RPM in the Netherlands and Germany. The impact of imputation, parameter, and case-mix uncertainty on these outcomes was explored using probabilistic analysis. Results Length of hospitalization, number of unscheduled admissions, and number of outpatient visits were lower in the remote monitoring group in all three countries. Number of hospital admissions was higher, and number of calls was lower in the Netherlands and Germany but not in France. Costs were lower in both the Netherlands (−€1041, 95% confidence interval (CI): −€3308, €1005) and Germany (−€2865, 95% CI: −€7619, €1105), while incremental effectiveness differed: −0.003 (95% CI: −0.114, 0.107) QALY in the Netherlands and +0.086 (95% CI: −0.083, 0.256) in Germany. Commercial headroom was estimated at €881 (95% CI: −€5430, €7208) in the Netherlands and €5005 (95% CI: −€1339, €11,960) in Germany. Discussion RPM was found to result in reduced medical resource use and travel time. Whether it is cost saving or cost effective strongly depends on the costs of remote monitoring. Trial registration number and trial register ClinicalTrials.gov: NCT01691586.

BACKGROUND Patient-centred care (PCC) including collaborative practices is the core component of modern health care. Despite this, it has proven difficult to implement. AIMS To examine (1) healthcare professionals' (HCPs') perception of whether they perceive a PCC culture, their attitudes towards involving patients in decisions and their experiences of barriers for PCC; and (2) variables that may contribute to explain differences in perceived person-centred culture. METHODS A questionnaire survey of HCPs from 27 different departments from two university hospitals in Denmark. HCPs were eligible if they held a profession as physician, Registered Nurse, nurse assistant, physiotherapist, occupational therapist, dietician, midwife or psychologist and excluded if they reported not being involved in patient treatment and care. The questionnaire consisted of four items from the Context Assessment Index (CAI). The remaining items were purpose-designed. RESULTS In total 1140 (24% response rate) HCPs completed the questionnaire and were included in the analyses. Most of the HCPs perceived a culture of PCC (e.g. 91% agreed or agreed to a high degree that patients were provided with opportunities to participate in decisions). Most HCPs also held positive attitudes towards involving patients in decisions. Time and prioritisation from the management were perceived as barriers for PCC, and many HCPs also believed that involving patients in decisions could be difficult for the patients. The HCPs who were least involved in treatment and care, and working in the acute setting or in surgery, were least likely to perceive a PCC culture. HCPs with the longest or shortest educations, and HCPs working primarily with outpatients or with planned inpatients, were most likely to perceive a person-centred culture. CONCLUSION The HCPs generally perceived a culture of PCC and held positive attitudes towards involving patients in decisions. To further promote PCC, time and prioritisation must be invested at an organisational level.

Aims: The present study investigates whether loneliness and social isolation are associated with poor physical and mental health among adolescents and young adults, and whether age and gender play a role in the associations of loneliness and social isolation with mental and physical health. Methods: This study used cross-sectional self-report data from the 2017 Danish Health and Morbidity Surveys titled ‘How are you?’ ( N = 19,890, M = 22.6 years). Results: Logistic regression analyses showed that loneliness and social isolation were independently associated with poor physical and mental health. Loneliness was associated with increased odds of asthma, migraine, osteoarthritis, rheumatoid arthritis, hypertension, slipped disc/back pain, tinnitus, long-term mental illness, depressive symptomatology, anxiety symptomatology and alcohol problems. Social isolation was associated with decreased odds of having migraine, osteoarthritis and alcohol problems, and an increased risk of long-term mental illness and depressive symptomatology. Small age and gender differences were detected. Conclusions: In adolescents and young adults, loneliness and social isolation were associated with poor mental health and loneliness with poor physical health. These findings highlight the need for targeted prevention and intervention initiatives to alleviate loneliness and social isolation.

Background Patients receiving an implantable cardioverter defibrillator (ICD) generally adapt well to living with their device, but we know little about the prevalence of patients' body image concerns (BICs) post implant. Methods The objectives were to evaluate the psychometric properties of the ICD-BICQ, find a cut-off indicating BICs and determine the prevalence of BICs. Construct validity was determined using the Kaiser-Meyer-Olkin test, Scree-plot and Explorative Factor Analysis. Internal consistency was examined via Cronbach's alpha. Correlations to other validated questionnaires, a weighted and simple scale and a cut-off indicating BICs was evaluated. Results In total, 331 patients completed the 39-item ICD-BICQ together with: Type D Scale (DS14), Generalized Anxiety Disorder scale (GAD-7), Patient Health Questionnaire (PHQ-9), and Florida Patient Acceptance Survey (FPAS). Five patients were excluded due to reoperations, leaving 326 patients in the analyses. Results revealed a one-factor structure with 32 items and Cronbach's alpha at 0.948. A cut-off at 36 points displayed the 20% patients with the highest score of BICs. The prevalence was 29.8 % in women and 18.4 % in men. Conclusion The psychometric evaluation of the 32-item ICD-BICQ showed acceptable construct validity and internal reliability. We recommend a cut-off score at 36 points to identify patients at risk of having BICs. The prevalence of BICs indicated that both men and women are at risk of having BICs. The ICD-BICQ can be used in clinical practice to help healthcare professionals to identify patients at risk of BICs and as to evaluate BICs when implementing new operation techniques. This article is protected by copyright. All rights reserved.

OBJECTIVE: Depression is common in patients with coronary artery disease (CAD) and is associated with poor outcomes. Although different treatments are available, it is unclear which are best or most acceptable to patients, so we conducted a network meta-analysis of evidence from randomized controlled trials (RCTs) of different depression treatments to ascertain relative efficacy.METHODS: We searched for systematic reviews of RCTs of depression treatments in CAD and updated these with a comprehensive search for recent individual RCTs. RCTs comparing depression treatments (pharmacological, psychotherapeutic, combined pharmacological/psychotherapeutic, exercise, collaborative care) were included. Primary outcomes were acceptability (dropout rate) and change in depressive symptoms 8 week after treatment commencement. Change in 26-week depression and mortality were secondary outcomes. Frequentist, random-effects network meta-analysis was used to synthesize the evidence, and evidence quality was evaluated following Grading of Recommendations, Assessment, Development and Evaluations recommendations.RESULTS: Thirty-three RCTs (7240 participants) provided analyzable data. All treatments were equally acceptable. At 8 weeks, combination therapy (1 study), exercise (1 study), and antidepressants (10 studies) yielded the strongest effects versus comparators. At 26 weeks, antidepressants were consistently effective, but psychotherapy was only effective versus usual care. There were no differences in treatment groups for mortality. Grading of Recommendations, Assessment, Development and Evaluations ratings ranged from very low to low.CONCLUSIONS: Overall, the evidence was limited and biased. Although all treatments for post-CAD depression were equally acceptable, antidepressants have the most robust evidence base and should be the first-line treatment. Combinations of antidepressants and psychotherapy, along with exercise, could be more effective than antidepressants alone but require further rigorous, multiarm intervention trials.Systematic Review Registration: CRD42018108293 (International Prospective Register of Systematic Reviews).

Aims Anxiety and depression are prevalent in 20% of patients with ischaemic heart disease (IHD); however, treatment of psychological conditions is not commonly integrated in cardiac rehabilitation (CR). Internet-based psychological treatment holds the potential to bridge this gap. To examine the feasibility of an eHealth intervention targeting anxiety and depression in patients with IHD attending CR. Methods and results We used a mixed-methods design, including quantitative methods to examine drop-out and change in anxiety and depression scores, and qualitative methods (thematic analysis) to evaluate patients’ and nurses’ experiences with the intervention. The therapist-guided intervention consisted of 12 modules provided via a web-based platform. The primary outcome was drop-out, with a drop-out rate Conclusion Integrating an eHealth intervention in CR is feasible and the drop-out rate acceptable.

To design and evaluate a mental health treatment program and internet-based delivery platform for patients with ischemic heart disease (IHD) attending cardiac rehabilitation with the aim of reducing the risks associated with anxiety and/or depression. Patients diagnosed with IHD and comorbid anxiety and/or depression. Participatory design of treatment program and internet platform through staged inclusion of participants in two groups. Group 1 was enrolled as co-researchers with prolonged engagement in the project. Group 2 participated only in the pilot evaluation workshop. Three patients were included in Group 1, two patients in Group 2. Inclusion of patients proved challenging, but the extended collaboration with co-researchers yielded valuable circumstantial insight and resulted in the design of a novel nine-module treatment program. Additionally, the inclusion of two participant groups helped shape the development of an internet platform based on an open-source content management system. Our grouped participation method contributes with several recommendations and reflections of advantages of this approach. Collaboration with co-researchers helped us gain a deeper understanding of the impact of language on self-perception and potential stigma. Prolonged participation led to a higher level of trust and familiarity, which enabled uncovering of issues otherwise hidden.

OBJECTIVE: Psychosocial risk factors are common in patients with ischemic heart disease (IHD) and linked to poor prognosis. Psychosocial healthcare is recommended in international guidelines and has demonstrated positive effects, primarily on psychosocial symptoms. We examined the association between patient-reported psychosocial healthcare and hospital readmissions and mortality in patients with IHD.METHODS: A population-based cohort study with register-based follow-up. Patient-reported psychosocial healthcare was measured by seven items in a survey sent to a random sample of patients with incident IHD in Denmark in 2014. We used multivariable Cox proportional hazards models and Poisson regression to examine the association between psychosocial healthcare and readmissions and all-cause mortality.RESULTS: In total, 1083 (57%) patients were followed up to 4½ years. Low psychosocial support was reported by 53.4%, medium by 26.2% and high by 20.4% patients. The hazard of acute cardiac readmission for patients reporting low psychosocial healthcare was 2.08 higher than for patients reporting high psychosocial healthcare (95%CI:1.01-4.30). No association was found with time to first all-cause readmission. The acute cardiac readmission rate was 3.24 (95%CI:1.66-6.29) and 4.23 (95%CI:2.15-8.33) times higher among patients reporting low and medium psychosocial healthcare compared to high, and the all-cause readmission rate was 1.30 (95%CI:1.16-1.46) and 1.32 (95%CI:1.17-1.49) times higher. The hazard of death was 2.86 (95%CI:1.23-6.69) and 2.88 (95%CI:1.18-7.04) times higher among patients reporting low and medium psychosocial healthcare compared to high.CONCLUSION: In patients with IHD, a high level of patient-reported psychosocial healthcare was significantly associated with reduced hospital readmissions and all-cause mortality.

OBJECTIVE: To examine associations between baseline anxiety and depression and occurrence of ICD shocks and risk of mortality in patients with an implantable cardioverter defibrillator (ICD).METHOD: We systematically searched EMBASE, PubMed, PsycINFO, and CINAHL for eligible studies fulfilling the predefined criteria.RESULTS: We included 37 studies based on 25 different cohorts following 35,003 participants for up to seven years. We observed no association between baseline anxiety nor depression and the occurrence of ICD shocks. More than half of the identified studies (respectively 56% and 60%) indicated a significant association between baseline anxiety or depression and increased risk of mortality (anxiety: n = 5, ranging from Hazard ratios (HR):1.02 [Confidence intervals (CI) 95% 1.00-1.03] to HR:3.45 [CI 95% 1.57-7.60]; depression: n = 6, ranging from HR:1.03 [CI 95% 1.00-1.06] to HR:2.10 [CI 95% 1.44-3.05]). We found a significant association between high methodological quality of the primary study and the detection of a significant association (p < 0.01).CONCLUSIONS: Baseline anxiety and depression are associated with increased risk of mortality in patients with an ICD, but not with occurrence of ICD shocks. Inclusion of baseline anxiety and depression in risk stratification of mortality may be warranted.

According to the World Health Organization, palliative care must be available for everyone with life-threatening diseases. However, in daily practice the primary focus worldwide is on cancer patients. The aim of the article was to generate a national position statement as the first step in implementing palliative care in severe heart disease with focus on advanced heart failure, including tools to identify the need for and timing of palliative care and how palliative care could be organized in Denmark. A task force was formed in the Danish Society of Cardiology Heart Failure Working Group, and the position statement was prepared in collaboration with members from a broad group of specialties, including palliative medicine. Because of major gaps in evidence, the position statement was based on small and low-quality studies and clinical practice statements. This position statement was aligned with the European Society of Cardiology recommendation, focusing on relieving suffering from the early disease stages parallel to standard care and supplementing life-prolonging treatment. The statement delivers practical guidance on clinical aspects and managing symptoms during the three stages of advanced heart disease. Furthermore, the statement describes the importance of communication and topics to be broached, including deactivating implantable cardioverter defibrillators. The statement recommends a targeted effort on organizational strategies using high-quality assessment tools and emphasizes multidisciplinary and intersectoral collaboration. Danish cardiologists supported by allied professionals acknowledge the importance of palliative care in advanced heart disease. This national position statement intended to inform and influence policy and practice and can hopefully inspire other countries to take action toward implementing palliative care in advanced heart disease.

BackgroundAnxiety has been associated with adverse clinical outcomes in patients who have received an implantable cardioverter defibrillator (ICD). However, results are inconclusive likely due to different measures being used to assess anxiety. Hence, the current study aims to examine the prevalence and the association between anxiety, ventricular tachyarrhythmia's (VTa's) and all-cause mortality, respectively.MethodsPatients who received an ICD for the first time were recruited from 6 Dutch referral hospitals as part of the WEBCARE trial. Patients filled in validated questionnaires (GAD-7, STAI-S, HADS-A, ANX4, ICDC, FSAS) to assess their baseline anxiety symptomatology. Logistic regression analysis and Cox Regression analysis were performed to examine the association between anxiety with 1) VTa's and 2) mortality, respectively.ResultsA total of 214 Patients were included in the analysis with mean age 58.9 and 82.7% being male. The prevalence rates of anxiety varied depending on which questionnaire was used 12.4% (GAD-7), 17.5% (HADS-A), and 28.1% (STAI-S). (Cox) Regression analysis revealed that none of the anxiety measures was associated with VTa's or all-cause mortality in the current sample. Stratifying the sample by gender, the analysis showed that GAD-7, STAI-S, and ANX4 scores were associated with increased risk of VTa's but only in male patients.ConclusionsPrevalence rates of anxiety varied depending on the measurement tool used. No significant association between anxiety and VTa's and all-cause mortality was observed in the total sample. GAD-7, STAI-S, and ANX4 were associated with increased risk for VTa's but only in male patients.

Objective.Risk stratification within the ICD population warrants the examining of the role of protective- and risk factors. Current study examines the association between Type D personality, pessimism, and optimism and risk of ventricular tachyarrhythmias (VTa's) and mortality in patients with a first-time ICD 6 years post implantation.Methods.A total of 221 first-implant ICD patients completed questionnaires on optimism and pessimism (Life Orientation Test) and Type D personality (Type D scale DS14) 10 to 14 days after implantation. VTa's and allcause mortality 6 years post implant comprised the study endpoints.Results.Ninety (40.7%) patients had experienced VTa's and 37 (16.7%) patients died, 12 (5.4%) due to a cardiac cause. Adjusted logistic regression analysis showed that pessimism was significantly associated with increased risk of VTa's (OR = 1.09; 95% CI = 1.00–1.19; p = .05). Type D personality (OR = 1.05; 95% CI = 0.47–2.32; p = .91) and optimism (OR = 1.00; 95% CI = 0.90–1.12; p = .98) were not associated with VTa's. None of the personality types were associated with mortality.Conclusion.Pessimism was associated with VTa's but not with mortality. No significant association with either of the endpoints was observed for Type D personality and optimism. Future research should focus on the coexistent psychosocial factors that possibly lead to adverse cardiac prognosis in this patient population.

Aims Remote patient monitoring (RPM) systems offer a promising alternative to conventional In-Clinic check-ups, hereby reducing unnecessary clinic visits. Especially with the rise of the COVID-19 pandemic, this reduction is of paramount importance. Regarding the association between RPM and clinical outcomes, findings of previous studies have been inconsistent. The aim of this study is to elucidate the effect of partly substituting In-Clinic visits by RPM on clinical outcomes in implantable cardioverter-defibrillator (ICD) patients. Methods and results The study included 595 heart failure patients (LVEF ≤35%; NYHA Class II/III) implanted with an ICD compatible with the Boston Scientific LATITUDE™ system. Participants were randomized to RPM plus an annual In-Clinic visit or 3–6 months In-Clinic check-ups alone. The investigated endpoints after 2 years of follow-up included a composite of all-cause mortality and cardiac hospitalization, mortality and cardiac hospitalization as independent endpoints and ICD therapy. The incidence of mortality and hospitalization did not differ significantly as independent, nor as composite endpoint between the RPM and In-Clinic group (all Ps, Graphical Abstract Graphical Abstract

AIMS: Systematic screening for anxiety and depression is widely recommended as a core component of cardiac rehabilitation in ischemic heart disease, however, recommendation-practice gaps are common and limited knowledge exists about factors hindering and supporting implementation. The study aimed to assess adherence to national clinical guideline recommendations and to gain a greater understanding of the implementation of screening in real-world practice.METHODS: An observational, longitudinal mixed-methods design including hospitals and municipalities in Denmark. We retrieved nationwide survey data from 2013, 2015, 2018 and 2021 to assess adherence to screening on programme level, and clinical quality registry data from 2016 to 2020 to assess proportion of patients screened. Data were analysed descriptively. Semi-structured interviews with healthcare professionals were conducted in 2015 (n = 11) and 2020 (n = 11) to explore how screening was conducted and factors supporting implementation. Normalization Process Theory guided interviews and content analysis.RESULTS: Screening on programme level increased from 61% to 88% in hospitals and 20% to 89% in municipalities. The individual proportion of patients screened remained relatively stable in both hospitals and municipalities overall, however with considerable inter-site differences. Screening practices became more aligned to guidelines, pushed by formal recommendations and monitoring, and pulled by activities strengthening the knowledge and motivation among staff.CONCLUSION: Screening for anxiety and depression improved considerably over the seven-year period, from a scattered practice driven by individuals to a movement where healthcare professionals had a feeling of going with the flow. Nationwide implementation of screening requires national and local supporting activities and a continuous effort.

Aim: to assess whether participation in cardiac rehabilitation affects the probability of returning to work after ischaemic heart disease. Methods: the study population consisted of 24,509 patients (18–70 years of age) discharged from an inpatient admission at a Danish hospital during 2014–2018 and who were working before their admission. Only patients with a percutaneous coronary intervention or coronary artery bypass grafting surgery procedure and ICD-10 codes I20–I25 as their main diagnosis or ICD-10 codes I21, I240, I248 or I249 as secondary diagnosis during an emergency admission were included. Exposure was defined as participation in cardiac rehabilitation ( N = 15,742), and binary indicator of being at work in the last week of a given month were used as primary outcomes. Coarsened exact matching (CEM) of exposed and unexposed patients was used to reduce selection bias. Logistic regression models were applied on the matched population ( N = 15,762). Results: Less deprived and less comorbid patients were more likely to receive cardiac rehabilitation. CEM succeeded in arriving at a population where this selection was reduced and in this population we found that patients who received cardiac rehabilitation had a lower probability of returning to work after 3 months (OR 0.81, 95%CI: 0.77–0.84), a higher but insignificant probability after 6 (OR 1.02, 95%CI: 0.97–1.08), and a higher probability after 9 (OR 1.08, 95%CI: 1.02–1.15) and 12 months (OR 1.20, 95%CI: 1.13–1.28). Conclusions: Deprived and comorbid patients have lower use of cardiac rehabilitation. In a matched population where this bias is reduced, cardiac rehabilitation will increase the probability of returning to work.

PurposeTo investigate levels of empowerment, possibilities for empowerment and perceived importance of empowerment among Danes in cancer follow-up. MethodsFrom nation-wide registers a randomly selected group of people diagnosed with one of ten different cancer diagnoses between one and five years ago were invited to complete the newly developed ‘Cancer Patient Empowerment Questionnaire’ (CPEQ). Respondents who reported that they were in a follow-up program were included in the analysis. Frequencies of answers to the items in the questionnaire were calculated. ResultsIn total, 1,418 people with a diagnosis of cancer returned the questionnaire (response rate 54%). Of these, 1,042 reported being in follow-up and were included in the analysis. Most respondents experienced that there was a plan for their follow-up (83%) and felt at ease with both the frequency (80%) and content of the follow-up (78%). However, many also reported lack of possibilities for and/or low levels of empowerment. They were not aware of any decisions being made during their follow-up, had not received information about relevant patient associations, or had any conversations with healthcare professionals regarding their needs and wishes for their follow-up. Furthermore, almost 20% lacked information on and confidence in managing treatment-related side-effects, late complications and alarm symptoms. ConclusionMany respondents reported lack of possibilities for and/or low levels of empowerment in their cancer follow-up. This may have consequences for their quality of life and capabilities and opportunities for managing their own care.

COVID-19 has impacted research worldwide, with many researchers turning to online methods. While online and co-creation research methods are well established, there are no instructional articles or guides for researchers aiming to conduct online co-creation workshops. Such workshops can provide quality data and are increasingly used. This methods paper addresses this gap by outlining the steps involved in conducting online co-creation workshops. Using the TruSTFood sustainability food labelling study as an example, this paper provides instructions and considerations for researchers. It serves as a guide for those interested in or new to this area and can be used to transfer existing research online owing to social distancing and the pandemic or new research beyond.

Background Many patients with atrial fibrillation (AF) experience severe or disabling symptoms and suffer from impaired quality of life (QoL). AF symptoms are often not sufficiently alleviated by current treatments. Symptom preoccupation (fear of AF episodes, hypervigilance towards cardiac symptoms, worry about complications, avoidance of physical and social activities) plays an important role in AF disability and can be targeted by cognitive behavioural therapy (CBT). This is the first randomized controlled trial (RCT) evaluating internet-delivered CBT in patients with AF. Methods We randomized patients to 10 weeks of CBT or routine care with AF-education (EDU) only. Inclusion criteria were ECG documented paroxysmal AF (≥1 episode/month); AF-care according to ESC guidelines; symptoms ≥EHRA IIb. Exclusion criteria were recent or planned ablation and severe medical or psychiatric illness. CBT was delivered over the internet by clinical psychologists. Main components were exposure to cardiac-related physical sensations and reduction of AF-related avoidance behavior. Patients were evaluated at baseline, post-CBT and 3 months (3M) post-CBT. The primary endpoint was AF-specific QoL (AFEQT) at 3M. Secondary endpoints were symptom preoccupation (CAQ), symptom frequency (SCL), symptom severity (SCL), general QoL (WHODAS) and AF-specific healthcare (AFSS) (abbreviations: see table legend). AF burden was measured by 5-day continuous ECG recording. After 3M, patients in the EDU group were offered CBT. The CBT group was further evaluated at 6M and 12M. Results 127 patients (age 65.4±8.3; 58% female; AF duration 5.6±6.1 years) were randomized to CBT (n=65) or EDU (n=62). CBT significantly improved AF-specific QoL. The AFEQT score was 62.5±16.7 at baseline and increased by 21.0 in the CBT group compared to 6.0 in the EDU group resulting in an 15.0 points improvement (95% CI: 10.1–19.8; P Conclusion Internet delivered CBT significantly improved AF-specific QoL in patients with symptomatic paroxysmal AF already receiving routine AF care. The magnitude of QoL improvement was comparable to that obtained in recent rhythm control trials and the effects were sustained over 12 months. AF-specific CBT delivered via the internet has the potential to improve the well-being of a large group of patients who do not sufficiently improve from current treatment methods. Our data support the integration of psychological evaluation and treatment in a multifactorial approach to AF management. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The study was supported by grants from theSwedish Research Council (2016-01379), RegionStockholm (ALF project). Change in AFEQT score over study periodBetween group improvements

BACKGROUND: Little is known about the effects of non-pharmacological interventions among medication-overuse headache (MOH) patients, although non-pharmacological approaches combined with pharmacological treatment are recommended. The objective was to evaluate the effect of an educational programme as an add-on to standard treatment.METHODS: Medication-overuse headache patients were randomized (1:1) in a single-centre setting to standard treatment with 12 weeks of education (I-group) versus standard treatment (C-group). The primary outcome was measurement of reduction in headache days/last month at 9 months' follow-up. Secondary outcomes were headache intensity, acute medication intake, bothersomeness, disability, physical activity and patient satisfaction. The between-group differences were analysed using a mixed-effects model for repeated measurements with a between group factor (I-group vs. C-group) and a time factor (baseline, 4 and 9 months).RESULTS: Ninety-eight patients were randomized (I-group: n = 48, C-group: n = 50), with 40 and 39 patients completing the study, respectively. Intention-to-treat analyses showed that both groups experienced statistically significant reductions in headache days/last month (I-group: -4 ± 6 days (95% CI 2.47; 5.95), p < .001) versus C-group: -4 ± 9 days ([95% CI 1.53; 6.79], p = .003), but there were no significant differences between groups (mean ± SE):Δ: 0.7 days ([95% CI, -2.50; 3.93], p = .66). At follow-up, 85% from the I-group and 86% from C-group, no longer fulfilled the criteria for MOH.CONCLUSION: The compliance rate was high, indicating that patients were motivated for receiving education, but we found no additional benefits of adding an educational programme to standard treatment. Future research focusing on the MOH complexity, group heterogeneity, duration and content of educational programmes is warranted.SIGNIFICANCE: Randomized controlled trials (RCTs) of non-pharmacological intervention such as patient educational programmes are of great importance, as this approach is common in the clinical practice. Medication-overuse headache (MOH) is a heterogenetic patient group, which must be taken into account when conducting RCTs of non-pharmacological interventions. An educational programme based on Motivational Interviewing is well-tolerated among MOH patients, however, no superior effects were found from adding the educational programme to standard treatment versus standard treatment alone.

AimsThe European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD).Methods and resultsThe sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3–6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients’ medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients’ health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P ConclusionLarge clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586.

PURPOSE: Patient-reported health-related quality of life is a complementary healthcare outcome and important when assessing treatment efficacy. Using COSMIN methodological recommendations, this study evaluates the validity and reliability of a core heart disease-specific health-related quality of life questionnaire, the HeartQoL questionnaire (Danish version) in a sample of patients following heart valve surgery.DESIGN: This project involved a cross-sectional validity study and a test-retest reliability study.METHODS: Eligible patients completed the HeartQoL, the SF-36 health survey questionnaire, and the Hospital Anxiety and Depression Scale following heart valve surgery. Construct validity was tested using a priori hypotheses. Internal consistency reliability was assessed with Cronbach's alpha. An independent sample of patients participated in the test-retest study and reproducibility was determined with relative [intra-class correlation coefficient (ICC)] and absolute reliability [standard error of measurement (SEM) and smallest detectable change (SDC)].RESULTS: Internal consistency was high with Cronbach's alpha ≥ 0.87. ICC was 0.86-0.92. SEM ranged from 0.17 to 0.26 points and SDC ranged from 0.5 to 0.7 points. Construct validity was confirmed with 87% of all a priori hypotheses for predicted variables.CONCLUSIONS: The HeartQoL questionnaire demonstrates acceptable construct validity, internal consistency, and test-retest reproducibility in patients following heart valve surgery. Future studies should focus on assessing the responsiveness of the HeartQoL questionnaire over time and following heart valve surgery.

BACKGROUND: Knowledge of the level of healthcare utilization (HCU) and the predictors of high HCU use in patients with an implantable cardioverter defibrillator (ICD) is lacking. We examined the level of HCU and predictors associated with increased HCU in first-time ICD patients, using a prospective study design.METHODS: ICD patients (N = 201) completed a set of questionnaires at baseline, 3-, 6-, and 12 months after inclusion. A hierarchical multiple linear regression with 3 models was performed to examine predictors of HCU.RESULTS: HCU was highest between baseline and 3 months post-implantation and gradually decreased during 12 months follow-up. During the first year post implantation, only depression (β = 0.342, p = 0.002) was a significant predictor. Between baseline and 3 months follow-up, younger age (β = -.220, p < .01), NYHA class III/IV (β = .705, p = .01), and secondary indication (β = .148, p = .05) were independent predictors for increased HCU. Between 3 and 6 months follow-up, younger age (β = -.151, p = .05) and depression (β = .370, p < .001) predicted increased HCU. Between 6 and 12 months only depression (β = 0.355, p = 0.001) remained a significant predictor.CONCLUSIONS: Depression was an important predictor of increased HCU in ICD patients in the first year post implantation, particularly after 3 months post implantation. Identifying patients who need additional care and provide this on time might better meet patients' needs and lower future healthcare utilization. This article is protected by copyright. All rights reserved.

Funding Acknowledgements Type of funding sources: None. Objective Depression is common in patients with coronary artery disease (CAD) and is associated with poor outcomes. Although different treatments are available, it is unclear which are best or most acceptable to patients, so we conducted a network meta-analysis of evidence from randomized controlled trials (RCTs) of different depression treatments to ascertain relative efficacy. Methods We searched for systematic reviews of RCTs of depression treatments in CAD and updated these with a comprehensive search for recent individual RCTs. RCTs comparing depression treatments (pharmacological, psychotherapeutic, combined pharmacological/psychotherapeutic, exercise, collaborative care) were included. Primary outcomes were acceptability (dropout rate) and change in depressive symptoms 8-weeks post-treatment commencement. Change in 26-week depression and mortality were secondary outcomes. Frequentist, random effects network meta-analysis synthesized the evidence. GRADE was used to assess evidence quality. Results Thirty-three RCTs (7240 participants) provided analysable data. All treatments were equally acceptable. At 8-weeks, combination therapy (1 study), exercise (1 study), and antidepressants (10 studies) yielded the strongest effects versus comparators. At 26-weeks, antidepressants were consistently effective, but psychotherapy was only effective versus usual care. There were no differences in treatment groups for mortality. GRADE ratings ranged from very low to low. Conclusions All treatments were equally acceptable, while antidepressants appeared to have the most robust evidence base for post-CAD depression. The evidence base was limited and biased; conclusions based on this literature should be drawn cautiously and considered to be tentative. Rigorous, multi-arm intervention trials, including trials of combination therapies and exercise, are urgently needed.

Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Danish Heart Foundation OnBehalf DEFIB-WOMEN study group Background Patients adjust well to living with an implantable cardioverter defibrillator (ICD), but 20% develop anxiety and depression that may compromise their quality of life (QoL) and increase risk of ventricular tachyarrhythmias and mortality. Purpose We examined the incidence and correlates of new onset anxiety and depression during 24 months of follow-up in ICD patients without depression and anxiety. Methods Patients with a first-time ICD (n = 1040) enrolled in the national, multi-centre prospective observational DEFIB-WOMEN study completed questionnaires on anxiety, depression and physical QoL at baseline, 3-, 6-, 12-, and 24 months. Information on demographic and clinical data was obtained from the Danish Pacemaker and ICD Register. Results During 24 months of follow-up, 46-57 (4%-5%) patients developed new onset anxiety and 42-47 (4%-5%) new onset depression. The incidence of new onset comorbid anxiety and depression was higher with 69-80 (7%-8%). Age [HR:0.54; 95%CI:0.36-0.80], marital status [HR:1.66; 95%CI:1.01-2.73], secondary prevention indication [HR:1.43; 95%CI:1.00-2.04], Type D personality [HR:2.50; 95%CI:1.62-3.86], and lower self-reported physical functioning [HR:1.48; 95%CI:1.00-2.17] were associated with new onset anxiety during follow-up. Age [HR:0.57; 95%CI:0.37-0.89], higher self-reported physical functioning [HR:0.46; 95%CI:0.25-0.85], smoking [HR:2.13; 95%CI:1.33-3.40], Type D personality [HR:2.53; 95%CI: 1.57-4.05], and lower self-reported physical functioning [HR:1.64; 95%CI:1.08-2.48] were associated with new onset depression. Conclusion Between 4%-8% of patients with a first-time ICD with no anxiety or depression at baseline are at risk of new onset anxiety, depression, or comorbid anxiety and depression up to 24 months post implant, suggesting that safeguarding their QoL and prognosis warrants that we screen patients not only at baseline.