A call for action to include psychosocial management into holistic, integrated care for patients with atrial fibrillation.

Contemporary management of atrial fibrillation (AF) has become increasingly complex. Therefore, strong efforts have been made during the past decade to develop models for structured, integrated care for patients with AF. These have also been incorporated in international guidelines for the management of patients with AF. However, implementation of integrated care approaches in daily clinical practice is scarce and far from optimal, and it may require a re-thinking of the structure of the healthcare system. The reasons for the poor implementation are many, from limited time and economic resources to deficits in postgraduate education of healthcare professionals, lack of involvement of patients in how integrated care should be designed, and fragmentation of the healthcare system. Moreover, patients' psychological challenges, which not only impact patients' adherence to treatment but, if untreated, increase their risk of morbidity, mortality, and poor quality of life, are not given sufficient attention. It is time to start a necessary discussion of what integrated care should be, what it should contain, and what is necessary to implement it in daily clinical practice.

Health economic evaluation of blended collaborative care for older multimorbid heart failure patients: study protocol.

BACKGROUND: Integrated care, in particular the 'Blended Collaborative Care (BCC)' strategy, may have the potential to improve health-related quality of life (HRQoL) in multimorbid patients with heart failure (HF) and psychosocial burden at no or low additional cost. The ESCAPE trial is a randomised controlled trial for the evaluation of a BCC approach in five European countries. For the economic evaluation of alongside this trial, the four main objectives were: (i) to document the costs of delivering the intervention, (ii) to assess the running costs across study sites, (iii) to evaluate short-term cost-effectiveness and cost-utility compared to providers' usual care, and (iv) to examine the budgetary implications. METHODS: The trial-based economic analyses will include cross-country cost-effectiveness and cost-utility assessments from a payer perspective. The cost-utility analysis will calculate quality-adjusted life years (QALYs) using the EQ-5D-5L and national value sets. Cost-effectiveness will include the cost per hospital admission avoided and the cost per depression-free days (DFD). Resource use will be measured from different sources, including electronic medical health records, standardised questionnaires, patient receipts and a care manager survey. Uncertainty will be addressed using bootstrapping. DISCUSSION: The various methods and approaches used for data acquisition should provide insights into the potential benefits and cost-effectiveness of a BCC intervention. Providing the economic evaluation of ESCAPE will contribute to a country-based structural and organisational planning of BCC (e.g., the number of patients that may benefit, how many care managers are needed). Improved care is expected to enhance health-related quality of life at little or no extra cost. TRIAL REGISTRATION: The study follows CHEERS2022 and is registered at the German Clinical Trials Register (DRKS00025120).

Social Disconnectedness in Individuals with Cardiovascular Disease: Associations with Health Literacy and Treatment Burden.

BACKGROUND: Knowledge is limited on associations between social disconnectedness (i.e. loneliness and social isolation), health literacy and perceived treatment burden in individuals with cardiovascular disease (CVD). However, understanding these associations may be important for clinical practice. METHODS: This study used cross-sectional self-reported data from the 2017 Danish health and morbidity survey entitled 'How are you?', investigating the associations of loneliness and social isolation with low health literacy and high treatment burden in individuals with CVD (n = 2521; mean age = 65.7 years). RESULTS: Logistic regression analysis showed that loneliness and social isolation were associated with low health literacy in terms of difficulties in 'understanding health information' (loneliness: adjusted odds ratio (AOR) = 1.32, 95% confidence intervals (CI) [1.16, 1.50]; social isolation: AOR = 1.47, 95% CI [1.24, 1.73]) and 'engaging with healthcare providers' (loneliness: AOR = 1.53, 95% CI [1.37, 1.70]; social isolation: AOR = 1.21, 95% CI [1.06, 1.40]) and associated with high treatment burden (loneliness: AOR = 1.49, 95% CI [1.35, 1.65]; social isolation: AOR = 1.20, 95% CI [1.06, 1.37]). CONCLUSIONS: Our findings show that loneliness and social isolation coexisted with low health literacy and high treatment burden in individuals with CVD. These findings are critical as socially disconnected individuals experience more health issues. Low health literacy and a high treatment burden may potentially exacerbate these issues.

Does targeted positioning of the left ventricular pacing lead towards the latest local electrical activation in cardiac resynchronization therapy reduce the incidence of death or hospitalization for heart failure?

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. GOV IDENTIFIER: NCT03280862.

Efficacy of a web-based healthcare innovation to advance the quality of life and care of patients with an implantable cardioverter defibrillator (ACQUIRE-ICD): a randomized controlled trial.

AIMS: Modern clinical management of patients with an implantable cardioverter defibrillator (ICD) largely consists of remote device monitoring, although a subset is at risk of mental health issues post-implantation. We compared a 12-month web-based intervention consisting of goal setting, monitoring of patients' mental health-with a psychological intervention if needed-psychoeducational support from a nurse, and an online patient forum, with usual care on participants' device acceptance 12 months after implantation. METHODS AND RESULTS: This national, multi-site, two-arm, non-blinded, randomized, controlled, superiority trial enrolled 478 first-time ICD recipients from all 6 implantation centres in Denmark. The primary endpoint was patient device acceptance measured by the Florida Patient Acceptance Survey (FPAS; general score range = 0-100, with higher scores indicating higher device acceptance) 12 months after implantation. Secondary endpoints included symptoms of depression and anxiety. The primary endpoint of device acceptance was not different between groups at 12 months [B = -2.67, 95% confidence interval (CI) (-5.62, 0.29), P = 0.08]. Furthermore, the secondary endpoint analyses showed no significant treatment effect on either depressive [B = -0.49, 95% CI (-1.19; 0.21), P = 0.17] or anxiety symptoms [B = -0.39, 95% CI (-0.96; 0.18), P = 0.18]. CONCLUSION: The web-based intervention as supplement to usual care did not improve patient device acceptance nor symptoms of anxiety and depression compared with usual care. This specific web-based intervention thus cannot be recommended as a standardized intervention in ICD patients.

Return to work: does cardiac rehabilitation make a difference? Danish nationwide register-based study.

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.

Effects of screening for anxiety and depression in patients with ischaemic heart disease - a nationwide Danish register study.

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.

Effect of remote monitoring on clinical outcomes in European heart failure patients with an implantable cardioverter-defibrillator: secondary results of the REMOTE-CIED randomized trial.

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 <0.05). The results were similar regarding ICD therapy, except for appropriate ICD therapy (odds ratio 0.50; 95% confidence interval 0.26-0.98; P = 0.04). Exploratory subgroup analyses indicated that the effect of RPM differs between patients with specific characteristics, i.e. ≥60 years and permanent atrial fibrillation (all Ps < 0.05). CONCLUSION: RPM is non-inferior to conventional In-Clinic visits regarding clinical outcomes. Routine In-Clinic follow-up may partly be substituted by RPM without jeopardizing safety and efficiency, and thus reducing unnecessary In-Clinic visits. CLINICALTRIALS.GOV IDENTIFIER: NCT01691586.

Perceptions of person-centred care in two large university hospitals: A cross-sectional survey among healthcare professionals.

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.

Psychometric evaluation of the implantable cardioverter defibrillator body image concerns questionnaire (ICD-BICQ).

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) postimplant. METHODS: The objectives were to evaluate the psychometric properties of the ICD-body image concerns questionnaire (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. 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 .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.