The rise and fall of a social support intervention feasibility trial targeting loneliness in patients with cardiac disease - lessons learned and future perspectives.

BACKGROUND: One of the psychosocial factors recognized for its positive impact on health outcomes among patients with heart disease, is social support provided by network members. However, an increasing number of patients report to experience loneliness. This study addresses the gap in research on the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness. METHOD: A feasibility trial of a 6-month social support intervention targeted patients treated for cardiac disease who experienced loneliness. The intervention involved providing the patient with an informal caregiver, either a person from the patient's social network or a peer, in the long-term rehabilitation phase. Furthermore, the intervention included nurse consultations and motivational text messages. Feasibility was assessed in terms of acceptability and adherence. RESULTS: During October 2022-July 2023, n = 464 patients were screened for loneliness and 28 (6.0%) screened positive of which 17 (60.7%) accepted to be contacted and receive additional information about the social support intervention. Of these, 2 (11.8%) accepted participation. The low recruitment rate did not meet the predetermined acceptability criterion of 25%. CONCLUSION: This individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness was non-feasible. The study highlights the complexities of engaging lonely patients in a social support intervention program and contributes with valuable insights for future research aiming to develop effective social support interventions tailored to the needs of cardiac patients who experience loneliness. TRIAL REGISTRATION: The trial is registered on clinicaltrials.gov (NCT05503810) 18.08.2022.

The association between health-related quality of life, self-reported characteristics and 1- and 3-year mortality amongst cardiac patients with and without type 2 diabetes.

PURPOSE: The objectives amongst cardiac patients with and without type 2 diabetes were to (i) describe self-reported characteristics as health-related quality of life (HRQoL), health behaviour, body mass index (BMI) and physical shape and to (ii) investigate the association between self-reported characteristics and 1- and 3-year mortality. METHODS: Adult patients (≥ 18 years) discharged with a cardiac diagnosis were invited to participate in a national survey, DenHeart. Self-reported characteristics included HRQoL (EQ-5D-5L and HeartQol), health behaviour (alcohol and smoking), BMI and physical shape. Data were linked to national registries. The association between self-reported characteristics and 1- and 3-year mortality were investigated using the Cox Proportional Hazard Regression model, reported as hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: In total, 16,659 cardiac responders were included (n = 2,205 with type 2 diabetes, n = 14,454 without type 2 diabetes). Self-reported characteristics were worse amongst cardiac patients with type 2 diabetes compared to those without. After three years, the mortality rate was 14% amongst responders with diabetes and 7% amongst responders without type 2 diabetes (p ≤ 0.001). Better HRQoL was associated with a reduced risk of mortality amongst both groups. "Never been smoking" significantly reduced the risk of 1- and 3-year mortality amongst cardiac patients without diabetes, whereas good physical shape was associated with a reduced risk across both groups. CONCLUSION: HRQoL, health behaviour, BMI and physical shape are significantly worse amongst cardiac patients with type 2 diabetes. Better HRQoL was associated with a reduced risk of mortality amongst both groups, whereas other self-reported characteristics and the mortality risk varied.

Association Between Risk Factors and Readmission for Patients With Atrial Fibrillation Treated With Catheter Ablation: Results From the Nationwide DenHeart Study.

BACKGROUND: Because of high readmission rates for patients treated with ablation for atrial fibrillation (AF), there is great value in nurses knowing which risk factors make the largest contribution to readmission. OBJECTIVE: The aims of this study were to (1) describe potential risk factors at discharge and (2) describe the associations of risk factors with readmission from 60 days to 1 year after discharge. METHODS: Data from a national cross-sectional survey exploring patient-reported outcomes were used in conjunction with data from national health registers. This study included patients who had an ablation for AF during a single calendar year. The Hospital Anxiety and Depression Scale and questions on risk factors were included. Sociodemographic and clinical data were collected through registers, and readmissions were examined at 1 year. RESULTS: In total, 929 of 1320 (response rate, 70%) eligible patients treated with ablation for AF completed the survey. One year after ablation, there were 333 (36%) acute readmissions for AF and 401 (43%) planned readmissions for AF. Readmissions were associated with ischemic heart disease, anxiety, and depression. CONCLUSION: High observed readmission rates were associated with risk factors that included anxiety and depression. Postablation care should address these risk factors.

Sex Differences in Patient-Reported Outcomes in the Immediate Recovery Period After Resuscitation: Findings From the Cross-sectional DenHeart Survey.

BACKGROUND: A paucity of resuscitation studies have examined sex differences in patient-reported outcomes upon hospital discharge. It remains unclear whether male and female patients differ in health outcomes in their immediate responses to trauma and treatment after resuscitation. OBJECTIVES: The aim of this study was to examine sex differences in patient-reported outcomes in the immediate recovery period after resuscitation. METHODS: In a national cross-sectional survey, patient-reported outcomes were measured by 5 instruments: symptoms of anxiety and depression (Hospital Anxiety and Depression Scale), illness perception (Brief Illness Perception Questionnaire [B-IPQ]), symptom burden (Edmonton Symptom Assessment Scale [ESAS]), quality of life (Heart Quality of Life Questionnaire), and perceived health status (12-Item Short Form Survey). RESULTS: Of 491 eligible survivors of cardiac arrest, 176 (80% male) participated. Compared with male, resuscitated female reported worse symptoms of anxiety (Hospital Anxiety and Depression Scale-Anxiety score ≥8) (43% vs 23%; P = .04), emotional responses (B-IPQ) (mean [SD], 4.9 [3.12] vs 3.7 [2.99]; P = .05), identity (B-IPQ) (mean [SD], 4.3 [3.10] vs 4.0 [2.85]; P = .04), fatigue (ESAS) (mean [SD], 5.26 [2.48] vs 3.92 [2.93]; P = .01), and depressive symptoms (ESAS) (mean [SD], 2.60 [2.68] vs 1.67 [2.19]; P = .05). CONCLUSIONS: Between sexes, female survivors of cardiac arrest reported worse psychological distress and illness perception and higher symptom burden in the immediate recovery period after resuscitation. Attention should focus on early symptom screening at hospital discharge to identify those in need of targeted psychological support and rehabilitation.

From expert to novice and back: a qualitative study of interprofessional collaboration and the experiences of frontline healthcare professionals during the first wave of COVID-19.

BACKGROUND: The global coronavirus disease 2019 pandemic put extreme pressure on healthcare systems worldwide, forcing a heavy workload on healthcare professionals. Frontline treatment and care for patients with coronavirus disease 2019 compelled healthcare professionals to rapidly adapt to new working conditions. This study explores the experiences of frontline healthcare professionals to learn more about how frontline work affects their learning and skills development but also interprofessional collaboration during a pandemic. METHODS: In-depth, one-to-one semi-structured interviews were conducted with 22 healthcare professionals. A broad interdisciplinary group, the participants were employed in public hospitals in four of Denmark's five regions. Using a reflexive methodology for the data analysis allowed reflexive interpretation when interpreting subjects and interpreting the interpretation. RESULTS: The study identified two empirical themes: into the unknown and in the same boat, which we critically interpreted using learning theory and theory on interprofessionalism. The study found that the healthcare professionals moved from being experts in their own fields to being novices in the frontline of the pandemic, and then back to being experts based on interprofessional collaboration that included shared reflection. Working in the frontline was imbued with a unique atmosphere in which workers were equals and functioned interdependently, the barriers normally obstructing interprofessional collaboration set aside to focus on combating the pandemic. CONCLUSIONS: This study reveals new insights regarding knowledge on frontline healthcare professionals in terms of learning and developing new skills, as well as the importance of interprofessional collaboration. The insights contributed to the understanding of the importance of shared reflection and how the development of expertise was a socially embedded process where discussions were possible without fear of being ridiculed and healthcare professionals were willing to share their knowledge.

The association between cardiac drug therapy and anxiety among cardiac patients: results from the national DenHeart survey.

BACKGROUND: Neuropsychiatric side effects of cardiac drugs such as nervousness, mood swings and agitation may be misinterpreted as symptoms of anxiety. Anxiety in cardiac patients is highly prevalent and associated with poor outcomes, thus an accurate identification is essential. The objectives were to: (I) describe the possible neuropsychiatric side effects of common cardiac drug therapies, (II) describe the use of cardiac drug therapy in cardiac patients with self-reported symptoms of anxiety compared to those with no symptoms of anxiety, and (III) investigate the association between the use of cardiac drug therapy and self-reported symptoms of anxiety. METHODS: DenHeart is a large national cross-sectional survey combined with national register data. Symptoms of anxiety were measured by the Hospital Anxiety and Depression Scale (HADS-A) on patients with ischemic heart disease, arrhythmia, heart failure and heart valve disease. Side effects were obtained from 'product summaries', and data on redeemed prescriptions obtained from the Danish National Prescription Registry. Multivariate logistic regression analyses explored the association between cardiac drug therapies and symptoms of anxiety (HADS-A ≥ 8). RESULTS: Among 8998 respondents 2891 (32%) reported symptoms of anxiety (HADS-A ≥ 8). Neuropsychiatric side effects were reported from digoxin, antiarrhythmics, beta-blockers, ACE-inhibitors and angiotensin receptor antagonists. Statistically significant higher odds of reporting HADS ≥ 8 was found in users of diuretics, lipid-lowering agents, nitrates, antiarrhythmics and beta-blockers compared to patients with no prescription. CONCLUSION: Some cardiac drugs were associated with self-reported symptoms of anxiety among patients with cardiac disease. Of these drugs neuropsychiatric side effects were only reported for antiarrhythmics and beta-blockers. Increased awareness about the possible adverse effects from these drugs are important.

Patient-reported outcomes, sociodemographic and clinical factors are associated with 1-year mortality in patients with ischemic heart disease-findings from the DenHeart cohort study.

PURPOSE: In patients with ischemic heart disease, the objectives were (1) to explore associations between patient-reported outcomes, sociodemographic, and clinical factors at discharge and 1-year all-cause mortality and (2) to investigate the discriminant predictive performance of the applied patient-reported outcome instruments on 1-year all-cause mortality. METHODS: Data from the Danish national DenHeart cohort study were used. Eligible patients (n = 13,476) were invited to complete a questionnaire-package, of which 7167 (53%) responded. Questionnaires included the 12-item Short form health survey (SF-12), Hospital anxiety and depression scale (HADS), EQ-5D, HeartQoL, Edmonton symptom assessment scale (ESAS), and ancillary questions on, e.g., social support. Clinical and demographic characteristics were obtained from registers, as were data on mortality. Comparative analyses were used to investigate differences in patient-reported outcomes. Mortality associations were explored using multifactorially adjusted Cox regression analyses. Predictive performance was analyzed using receiver operating characteristics (ROC). RESULTS: Patient-reported outcomes at discharge differed among those alive versus those deceased at one year, e.g., depression (HADS-Depression ≥ 8) 19% vs. 44% (p < 0.001). Associations with 1-year mortality included feeling unsafe about returning home from the hospital; hazard ratio (HR) 2.07 (95% CI 1.2-3.61); high comorbidity level, HR 3.6 (95% CI 2.7-4.8); and being unmarried, HR 1.60 (95% CI 1.33-1.93). Best predictive performance was observed for SF-12 physical component summary (Area under the curve (AUC) 0.706). CONCLUSION: Patient-reported health, sociodemographic, and clinical factors are associated with 1-year mortality. We propose systematic screening with robust predictive tools to identify patients at risk and healthcare initiatives to explore and offer effective treatment to modify patient-reported health indicators.

Long-term effects of cardiac rehabilitation after heart valve surgery - results from the randomised CopenHeartVR trial.

Aims. The CopenHeartVR trial found positive effects of cardiac rehabilitation (CR) on physical capacity at 4 months. The long-term effects of CR following valve surgery remains unclear, especially regarding readmission and mortality. Using data from he CopenHeartVR Trial we investigated long-term effects on physical capacity, mental and physical health and effect on mortality and readmission rates as prespecified in the original protocol. Methods. A total of 147 participants were included after heart valve surgery and randomly allocated 1:1 to 12-weeks exercise-based CR including a psycho-educational programme (intervention group) or control. Physical capacity was assessed as peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing, mental and physical health by Short Form-36 questionnaire, Hospital Anxiety and Depression Scale, and HeartQol. Mortality and readmission were obtained from hospital records and registers. Groups were compared using mixed regression model analysis and log rank test. Results. No differences in VO2 peak at 12 months or in self-assessed mental and physical health at 24 months (68% vs 75%, p = .120) was found. However, our data demonstrated reduction in readmissions in the intervention group at intermediate time points; after 3, 6 (43% vs 59%, p = .03), and 12 (53% vs 67%, p = .04) months, respectively, but no significant effect at 24 months. Conclusions. Exercise-based CR after heart valve surgery reduces combined readmissions and mortality up to 12 months despite lack of improvement in exercise capacity, physical and mental health long-term. Exercise-based CR can ensure short-term benefits in terms of physical capacity, and lower readmission within a year, but more research is needed to sustain these effects over a longer time period. These considerations should be included in the management of patients after heart valve surgery.

Temperature change in children undergoing magnetic resonance imaging-An observational cohort study.

AIM: An increasing number of children undergo magnetic resonance imaging requiring anesthesia or sedation to ensure their immobility; however, magnetic resonance imaging may increase body temperature whereas sedation or anesthesia may decrease it. We investigated changes in body temperature in children who underwent sedation or anesthesia for magnetic resonance imaging. METHODS: Children aged 12 weeks-12 years undergoing anesthesia and magnetic resonance imaging were included in this prospective observational study. Tympanic body temperature was measured before and after magnetic resonance imaging, and the difference between measurements was calculated. Associations between the temperature difference and patient- or procedure-related factors were evaluated with linear and logistic regression analysis. RESULTS: A total of 74 children were included, of whom 5 (7%) had a temperature increase ≥0.5°C. Mean temperature difference was -0.24°C (SD 0.48) for the entire group and -0.28°C for the youngest children (0-2 years). The temperature difference correlated positively with the duration of imaging (unadjusted coefficient 0.26, 95% confidence interval (CI), (0.01; 0.52)). CONCLUSION: In this study of sedated or anesthetized children undergoing magnetic resonance imaging, clinically relevant increases in body temperature above 0.5°C were only found in a few patients. However, longer imaging duration tended to be associated with increased body temperature.

Cause of Death Among Cardiac Patients With and Without Anxiety.

BACKGROUND: Mental distress is reported internationally among patients with cardiac disease. A Danish survey found that 25% of patients with cardiac disease experienced symptoms indicating anxiety and that anxiety was associated with an increased risk of death. AIM: The aims of this study were to (1) compare cause of death patterns among deceased cardiac patients with anxiety to those without anxiety and (2) examine the association between anxiety symptoms and specific causes of death. METHODS: We used data from the DenHeart survey to evaluate symptoms of anxiety at discharge by using the Hospital Anxiety and Depression Scale. Data on mortality in the 3 years after discharge and cause of death according to International Classification of Diseases-10 classification came from national registers. Cause of death was compared between patients with and without anxiety using χ2 tests. The association between symptoms of anxiety and cause of death was investigated using logistic regression. RESULTS: Of 12 913 patients included, a total of 1030 (8%) died within 3 years. After 1 year, 4% of patients with anxiety symptoms had died versus 2% of patients without; after 3 years, the proportions were 9% versus 8%, respectively. Almost all died of natural causes irrespective of anxiety symptoms. No statistically significant differences were found regarding the cause of death between patients with and without anxiety. CONCLUSION: Despite higher mortality rates in patients with cardiac disease with anxiety symptoms, the pattern of cause of death was identical for patients with cardiac disease with and without anxiety symptoms. It seems that an acceleration of morbid processes leading to mortality is more likely than a difference in cause of death. However, further research is needed to better understand the behavioral and pathophysiological processes that cause the higher mortality seen among patients reporting symptoms of anxiety.

Prognostic value of a brief loneliness questionnaire for patients with coronary heart disease: Proposal for a prediction model.

BACKGROUND: In patients with coronary heart disease (CHD), loneliness is associated with increased risk of morbidity and mortality. No predictive tool is available to detect patients who are influenced by loneliness to a degree that impacts mortality. AIM: To: (i) propose a prediction model that detects patients influenced by loneliness to a degree that increases one-year all-cause mortality, (ii) evaluate model classification performance of the prediction model, and (iii) investigate potential questionnaire response errors. METHOD: A cohort of patients with CHD (n = 7169) responded to a national cross-sectional survey, including two questions on loneliness. Information on cohabitation and follow-up information on one-year all-cause mortality were obtained from national registers. Prediction model development was based on the prognostic values of item responses in the questionnaire on loneliness and of cohabitation, evaluated with Cox-proportional Hazards Ratio (HR). Item responses which significantly predicted one-year mortality were included in the high-risk loneliness (HiRL) prediction model. Sensitivity, specificity and likelihood ratio were calculated to evaluate model classification performance. Sources of response errors were evaluated using verbal probing technique in an additional cohort (n = 7). The TRIPOD checklist has been used to ensure transparent reporting. RESULTS: Two item responses significantly predicted one-year mortality HR = 2.24 (95%CI = 1.24-4.03) and HR = 2.65 (95%CI = 1.32-5.32) and were thus included in the model. Model classification performance showed a likelihood ratio of 1.89. Response error was evaluated as low. CONCLUSION: Based on the prognostic value in a loneliness questionnaire, a prediction model suitable to screen patients with CHD for high-risk loneliness was suggested. RELEVANCE TO CLINICAL PRACTICE: The HiRL prediction model is a short and easy-to-use screening tool that offers clinical staff to identify patients with CHD who are influenced by loneliness to a degree that impacts mortality. However, further evaluation of model performance and questionnaire validation is recommended before integrating the model into clinical practice.

Testing for COVID-19 regulates behavior in the general population: A qualitative study of experiences of awaiting test result for COVID-19.

AIM: This study aimed to explore experiences of awaiting a test result for COVID-19 among individuals from the general population. METHODS: Fifteen participants were recruited from COVID-19 testing tents in the Capital Region of Denmark in March and April 2020. A phenomenological-hermeneutic approach inspired by Ricoeur's theory of interpretation was used. RESULTS: The analysis revealed five themes. (1) The participants' experiences of awaiting a COVID-19 test result illuminated concerns related to infecting others rather than their own health. Experiences of guilt for not taking all possible precautions to avoid the spread of COVID-19 were described and thoughts of potentially having exposed others bothered the participants. (2) The test result would guide their precautions and therefore regulate behaviour at home and in society. (3) Even though the participants did not take all possible precautions they made some changes in their everyday lives. (4) Leaving the individual with the responsibility for taking precautions based on their subjective experiences created feelings of insecurity and uncertainty. (5) Being met by health professionals was an experience that meant for the particpants that behaviour towards limiting the infection became very clear. The seriousness experienced around the test situation facilitated this attitude and behaviour in the participants. Conclusion: This study illuminated how testing for COVID-19 regulates behavior in the general population. The testing was both important for the individual's cautious behavior towards other people, work and in getting around in society but also a way to regulate behavior from a societal perspective to quicken suppression and avoid transmission of COVID-19.

Like soldiers on the front - a qualitative study understanding the frontline healthcare professionals' experience of treating and caring for patients with COVID-19.

BACKGROUND: While people in the societies must stay home to reduce spread of the newly discovered coronavirus, healthcare professionals do the exact opposite. For them the coronavirus is an enemy that should be defeated as a part of one's job. They do, however, also have a daily life with family while doing their work obligations. The purpose of this study was to gain an in-depth understanding of the frontline healthcare professionals' experience of balancing work life and family life during the COVID-19 pandemic. METHODS: A sample of 22 frontline healthcare professionals caring for patients with COVID-19 was included and interviewed individually from May to August 2020. Ricoeur's phenomenological hermeneutical philosophy inspired the methodology in this study. RESULT: Frontline healthcare professionals treating and caring for patients with COVID-19 are, voluntarily or involuntarily, forced to be ready to change departments as well as being ready to face the unknown coronavirus. The frontline work leads to feelings of being abandoned among their families and friends due to the threat of bringing the infection home and spreading the virus. Although healthcare professionals are facing a working life filled with uncertainty and unpredictability impacting their family life, they express opposing feelings of being a part of something bigger. CONCLUSIONS: The work life balance for these healthcare professionals is threatened by changes in professional responsibilities, working hours and shifts. Fear of bringing the infection home challenges them ethically and creates a distance between healthcare professionals and their families, leading to a conflict within the individual if their work on the frontline is worth it - or if it is a too high price to pay. Despite facing a working life filled with uncertainty and unpredictability the healthcare professionals are being a part of something bigger that contributes to a fighting spirit and professional pride outweighing the negative consequences; like being soldiers on the front.

Illness Perception After Heart Valve Surgery: Differences Among Men and Women.

BACKGROUND: Illness perception is composed of thoughts, ideas, and beliefs about illness, and a negative illness perception is known to be associated with poor outcomes. Among men and women, clinical outcomes after heart valve surgery are known to differ, but knowledge about differences in illness perception is sparse. OBJECTIVES: The aim of this study is to describe the differences in illness perception among men and women after open heart valve surgery and to identify sociodemographic and clinical characteristics associated with worse illness perception in men and women. METHODS: In a national cross-sectional study combined with register-based clinical and sociodemographic information, data on illness perception were collected with the Brief Illness Perception Questionnaire.Worse illness perception was defined as the worst quartile of each item of the Brief Illness Perception Questionnaire. Multiple logistic regression analyses were conducted to explore characteristics associated with worse illness perception. RESULTS: Of 1084 eligible patients, 32% (n = 349) completed the questionnaire (67% men; mean age, 68 years). Compared with men, women reported significantly worse scores of illness perception in 6 of 8 items. Furthermore, being female, age, length of stay, and comorbidity were associated with worse illness perception (worse quartile of scores). Age, higher educational level, and comorbidity were found to be associated with worse illness perception for men and length of stay for women. CONCLUSION: After open heart valve surgery, illness perception differs among men and women, with women having worse illness perception. Among the total population, being female, age, a longer length of stay, and comorbidity were also associated with worse illness perception.

It's Not Just a Virus! Lived Experiences of People Diagnosed With COVID-19 Infection in Denmark.

The purpose of this study was to explore the lived experiences of people infected with the coronavirus in Denmark during the first phase of the pandemic. An explorative qualitative design underpinned by a phenomenological hermeneutical approach was applied. Fifteen individuals with confirmed COVID-19 infection were included and interviewed individually by telephone. Analyses were inspired by Ricoeur's interpretation theory. The study illuminated how being diagnosed with COVID-19 was experienced not just a virus infecting the participants' biology; it was also a threat to their existence and bodily perception as well as an interference in ordinary social relationships. Beyond a supportive approach, the participants experienced being a special case where people around them acted with excitement and curiosity. Responsibility for existential and emotional care after COVID-19 has been placed with the individual ill person and within their ordinary social circle. We suggest follow-up and rehabilitation for people during and after COVID-19 to support recovery.

Am I going to die now? Experiences of hospitalisation and subsequent life after being diagnosed with aortic dissection.

Aortic dissection is a life-threatening condition with mortality up to 75%. In the acute phase, patients are constrained with total bed rest until pain relief and blood pressure has been stabilised. Some need surgery. Aortic dissection is associated with anxiety and poor health-related quality of life. However, no study has explored the experience of living through aortic dissection. The aim of this study was to explore the patient experience of living through aortic dissection. Data were collected in interviews with 10 patients who lived through aortic dissection. Data were gathered and analysed using a phenomenological approach. The qualitative analysis revealed four themes; 'Am I going to die now? - the existential turning point when diagnosed with life-threatening aortic dissection', 'compromised integrity during admission - experiences of hospitalisation', 'Signals from my body - a new awareness of the body after discharge', 'What can I do? - uncertainties about physical activity in daily life posthospitalisation'. Experiences of aortic dissection are a life-threatening and overwhelming existential life situation which includes a period of constraining hospitalisation and experiences a compromised integrity. Patients have substantial concerns regarding body signals and a constantly uncertainty about what kind of activity level they can sustain which affect their mental well-being and their daily life. These findings contribute to understanding and elaborating a more nuanced description of being diagnosed with aortic dissection, which is essential when planning high-quality treatment and care, developing sufficient follow-up and preventing adverse events.

Psychometric properties of the Danish Hospital Anxiety and Depression Scale in patients with cardiac disease: results from the DenHeart survey.

BACKGROUND: Anxiety and depression symptoms are common among cardiac patients. The Hospital Anxiety and Depression Scale (HADS) is frequently used to measure symptoms of anxiety and depression; however, no study on the validity and reliability of the scale in Danish cardiac patients has been done. The aim, therefore, was to evaluate the psychometric properties of HADS in a large sample of Danish patients with the four most common cardiac diagnoses: ischemic heart disease, arrhythmias, heart failure and heart valve disease. METHODS: The DenHeart study was designed as a national cross-sectional survey including the HADS, SF-12 and HeartQoL and combined with data from national registers. Psychometric evaluation included analyses of floor and ceiling effects, structural validity using both exploratory and confirmatory factor analysis and hypotheses testing of convergent and divergent validity by relating the HADS scores to the SF-12 and HeartQoL. Internal consistency reliability was evaluated by Cronbach's alpha, and differential item functioning by gender was examined using ordinal logistic regression. RESULTS: A total of 12,806 patients (response rate 51%) answered the HADS. Exploratory factor analysis supported the original two-factor structure of the HADS, while confirmatory factor analysis supported a three-factor structure consisting of the original depression subscale and two anxiety subscales as suggested in a previous study. There were floor effects on all items and ceiling effect on item 8. The hypotheses regarding convergent validity were confirmed but those regarding divergent validity for HADS-D were not. Internal consistency was good with a Cronbach's alpha of 0.87 for HADS-A and 0.82 for HADS-D. There were no indications of noticeable differential item functioning by gender for any items. CONCLUSIONS: The present study supported the evidence of convergent validity and high internal consistency for both HADS outcomes in a large sample of Danish patients with cardiac disease. There are, however, conflicting results regarding the factor structure of the scale consistent with previous research. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01926145.

What to expect after open heart valve surgery? Changes in health-related quality of life.

PURPOSE: To (i) describe changes in health-related quality of life (HRQoL) pre-operatively, at discharge, and 4 weeks after discharge following open heart surgery, (ii) compare the performance of the EuroQol Questionnaire (EQ-5D 5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) against an anchor-based approach, and to (iii) investigate the association between HRQoL and 180-day readmission. METHODS: A prospective, consecutive cohort (single-center study) of 291 patients completed the EQ-5D 5L and KCCQ pre-operatively, at discharge and 4 weeks post-discharge. Changes in HRQoL over time were evaluated, and the performance of the instruments was investigated. The association between HRQoL and readmission were investigated with Cox Proportional Hazard models. RESULTS: Scores of the EQ-5D Index and VAS decreased significantly from the pre-operative assessment to discharge and improved from discharge to 4 weeks after. The KCCQ scores significantly improved from baseline to 4 weeks after. Minimal clinically important improvements from before surgery to 4 weeks after were seen among 24% (EQ-5D Index), 45% (EQ-5D VAS), and 57% (KCCQ). More than one-third experienced worse HRQoL 1 month after discharge. Area under the curve (AUC) (performance of the instruments) demonstrated the following: EQ-5D Index AUC 0.622 (95% CI 0.540-0.704), VAS AUC 0.674 (95% CI 0.598-0.750), and KCCQ AUC 0.722 (95% CI 0.65-0.792). None of the HRQoL measurements were associated with 180-day readmission. CONCLUSIONS: This study revealed that HRQoL measured with the EQ-5D is significantly worse at discharge compared to before surgery, but scores increases within the first month measured with the EQ-5D and the KCCQ. The EQ-5D and KCCQ have a moderate correlation with an anchor-based approach but were not associated with readmission.

The association between self-reported health status and adverse events: a comparison among coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI).

PURPOSE: While several studies have investigated clinical outcomes following coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI), studies investigating self-reported health and the association with adverse outcomes are limited. Thus, the aim was to investigate differences in health-related quality of life (HRQoL), anxiety and depression at discharge and the association with a composite endpoint of the first event of acute cardiac readmission, revascularisation or 1-year mortality among patients undergoing CABG vs. PCI. METHODS: Data from the national cohort study, DenHeart, were used, including measures of HRQoL; EuroQoL-5D-5L (EQ-5D Index Score and VAS) and HeartQoL (Global, Physical and Emotional), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and register-based follow-up. A total of 7000 patients were included (CABG n = 652, PCI n = 6348) (median age 65, 75% men). Cox Proportional Hazard models were performed among a propensity-matched population of responders (n = 520). RESULTS: HRQoL was significantly better among patients undergoing PCI vs. CABG, but with no differences in time to readmission or revascularisation. HRQoL, anxiety and depression were significantly associated with the risk of the composite endpoint among the PCI group (Hazard Ratio, HR (95% confidence intervals, CI) [EQ-5D index score 3.07 (1.67-5.67), EQ-5D VAS 0.97 (0.96-0.99), HeartQol Global 0.61 (0.38-0.95), HeartQol Emotional 0.56 (0.39-0.80), HADS-D ≥ 8 3.12 (1.61-6.01), HADS-A ≥ 8 2.08 (1.14-3.80)]. CONCLUSION: Patients undergoing PCI reported better HRQoL at discharge compared with patients undergoing CABG, whereas readmission rates were similar. Self-reported health was associated with the risk of adverse events among patients undergoing PCI, but not among patients undergoing CABG. CLINICAL TRIAL REGISTRATION: NCT01926145.

Cardiac Rehabilitation for Patients Treated for Atrial Fibrillation With Ablation Has Long-Term Effects: 12-and 24-Month Follow-up Results From the Randomized CopenHeartRFA Trial.

OBJECTIVE: To assess outcomes at 12 and 24 months after participation in a multidisciplinary cardiac rehabilitation program plus usual care compared with usual care alone for patients treated for atrial fibrillation with catheter ablation. DESIGN: Long-term follow-up on the randomized CopenHeartRFA trial. SETTING: Patients were enrolled and outcome assessed at the hospital and the intervention were carried out at the hospital or at local rehabilitation centers. PARTICIPANTS: Patients (N=210) treated for atrial fibrillation with catheter ablation included in the CopenHeartRFA trial. INTERVENTIONS: A 6-month cardiac rehabilitation program consisting of physical exercise and psychoeducational consultations plus usual care or usual care alone. MAIN OUTCOME MEASURES: Physical capacity was measured by peak oxygen uptake (Vo2peak) at 12 months, and patient-reported outcomes on perceived health, anxiety, and depression were collected by validated questionnaires at 12 and 24 months. Information on hospital admissions and mortality was collected through national registers up to 24 months. RESULTS: Mean Vo2peak was higher at 12 months in the cardiac rehabilitation group (cardiac rehabilitation group: 25.82 mL/kg/min vs usual care group, 22.43 mL/kg/min, P=.003). A lower proportion of patients had high levels of anxiety at 24 months in the cardiac rehabilitation group compared to usual care (12% vs 24%, P=.004). There was no difference in mortality or hospital admissions at 24 months between groups. CONCLUSIONS: This long-term follow-up of a comprehensive multidisciplinary cardiac rehabilitation program for patients treated for atrial fibrillation with catheter ablation found sustained improvements with respect to physical capacity and anxiety compared to usual care but no difference on mortality or hospital admission.