Risk of body weight changes among Danish children and adolescents during the COVID-19 pandemic.

BACKGROUND: Knowledge of COVID-19 and the pandemic's effects on Danish children's body weight is limited. OBJECTIVE: Objectives were to investigate (I) risk of weight changes among Danish children with and without SARS-CoV-2, (II) associations between weight changes, psychological symptoms, and long COVID symptoms, and (III) weight distribution pre- and post-pandemic. METHODS: A national survey was administered to all Danish children aged 0-18 years, with prior COVID-19 (cases) and matched references including questions on weight, weight changes during the pandemic and long COVID-related symptoms. Descriptive statistics and logistic regression were used. Weight distribution was compared with a pre-pandemic database. RESULTS: In all, 17 627 cases and 54 656 references were included. The 4-18-year-old cases had lower odds of unintended weight gain. The 2-3-year-old cases had higher odds and the 15-18-year-old cases lower odds of weight loss compared to references. Regardless of COVID-19 status, any reported long COVID-related symptom was associated with a change in body weight. No sign of increasing obesity rates was found among Danish children post-pandemic. CONCLUSION: COVID-19 was associated with higher odds of weight loss in 2-3-year-olds and lower odds of unintended weight gain in 4-18-year-olds. Any long COVID-related symptom was associated with higher odds of weight changes regardless of COVID-19 status.

Patient-reported outcome is associated with health care costs in patients with ischaemic heart disease and arrhythmia.

AIMS: Systematic use of patient-reported outcomes (PROs) have the potential to improve quality of care and reduce costs of health care services. We aimed to describe whether PROs in patients diagnosed with heart disease are directly associated with health care costs. METHODS AND RESULTS: A national cross-sectional survey including PROs at discharge from a heart centre with 1-year follow-up using data from national registers. We included patients with either ischaemic heart disease (IHD), arrhythmia, heart failure (HF), or valvular heart disease (VHD). The Hospital Anxiety and Depression Scale, the heart-specific quality of life, the EuroQol five-dimensional questionnaire, and the Edmonton Symptom Assessment Scale were used. The economic analysis was based on direct costs including primary, secondary health care, and medical treatment. Patient-reported outcomes were available from 13 463 eligible patients out of 25.241 [IHD (n = 7179), arrhythmia (n = 4322), HF (n = 987), or VHD (n = 975)]. Mean annual total direct costs in all patients were €23 228 (patients with IHD: €19 479, patients with arrhythmia: €21 076, patients with HF: €34 747, patients with VDH: €48 677). Hospitalizations contributed overall to the highest part of direct costs. For patients discharged with IHD or arrhythmia, symptoms of anxiety or depression, worst heart-specific quality of life or health status, and the highest symptom burden were associated with increased economic expenditure. We found no associations in patients with HF or VHD. CONCLUSION: Patient-reported outcomes at discharge from a heart centre were associated with direct health care costs in patients with IHD and arrhythmia. REGISTRATION: ClinicalTrials.gov: NCT01926145.

Acute Traumatic Stress Screening Can Identify Patients and Their Partners at Risk for Posttraumatic Stress Disorder Symptoms After a Cardiac Arrest: A Multicenter Prospective Cohort Study.

BACKGROUND: Posttraumatic stress disorder (PTSD) is prevalent in patients who have had a cardiac arrest and their partners. Accordingly, acute traumatic stress screening is recommended, but its association with later PTSD symptoms has never been addressed in postresuscitation settings. OBJECTIVE: The aim of this study was to examine whether acute traumatic stress is associated with PTSD symptoms in patients who have had a cardiac arrest and their partners. METHODS: This multicenter longitudinal study of 141 patients and 97 partners measures acute traumatic stress at 3 weeks and PTSD symptoms at 3 months and 1 year after resuscitation, using the Impact of Event Scale. Linear regression models were used to evaluate the association between severity of acute traumatic stress and PTSD symptoms and post hoc to explore effects of group (patients/partners), age, and sex on acute traumatic stress severity. We categorized Impact of Event Scale scores higher than 26 at 3 months and 1 year as clinical severe PTSD symptoms . RESULTS: Higher acute traumatic stress severity is significantly positively associated with higher PTSD symptom severity at 3 months (patients and partners: P < .001) and 1 year (patients and partners: P < .001) postresuscitation, with the strongest association for women compared with men ( P = .03). Acute traumatic stress was higher in women compared with men across groups ( P = .02). Clinical severe PTSD symptoms were present in 26% to 28% of patients and 45% to 48% of partners. CONCLUSION: Experiencing a cardiac arrest may elicit clinical severe PTSD symptoms in patients, but particularly in their partners. Screening patients and partners for acute traumatic stress postresuscitation is warranted to identify those at increased risk of long-term PTSD symptoms.

Cardiovascular Rehabilitation Increases Walking Distance in Patients With Intermittent Claudication. Results of the CIPIC Rehab Study: A Randomised Controlled Trial.

OBJECTIVE: To examine whether a cardiac rehabilitation programme in a community based setting for patients with intermittent claudication (IC) affects walking ability, quality of life, and changes in health behaviour. The trial investigated a cross sector cardiovascular rehabilitation programme compared with usual care for patients having non-operative management. METHODS: The trial allocated 118 patients, with 1:1 individual randomisation to either an intervention or control group. Data were collected at a department of vascular surgery and at a healthcare centre in Denmark. The rehabilitation intervention consisted of usual care plus 12 weeks of exercise training, pedometer, health education, and text messages. The primary outcome was maximum walking distance at six months measured by treadmill walking test. The secondary outcomes were maximum walking distance at 12 months and pain free walking distance measured by treadmill walking test, healthy diet, level of physical activity, and quality of life (QoL) at six and 12 months. RESULTS: In the intervention group, 46 participants were analysed, with 47 in the control group. Following three months of rehabilitation, a 37% difference (95% CI 1.10 - 1.70; p = .005) was found between groups in maximum walking distance at six and 12 months, in favour of the intervention group. The same positive effect was found in physical activity, QoL, and healthy diet, but was not statistically significant in pain free walking distance and smoking. CONCLUSION: A specialised community based cardiac rehabilitation programme for patients with IC showed statistically and clinically significant effects on maximum walking distance, physical activity, quality of life, and healthy diet, but not on pain free walking distance and smoking, compared with usual care without rehabilitation.

Exercise-based cardiac rehabilitation for adults after heart valve surgery.

BACKGROUND: The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery. OBJECTIVES: To assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. We considered CR programmes consisting of exercise training with or without another intervention (such as an intervention with a psycho-educational component). SEARCH METHODS: We searched the Cochrane Central Register of Clinical Trials (CENTRAL), in the Cochrane Library; MEDLINE (Ovid); Embase (Ovid); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO); PsycINFO (Ovid); Latin American Caribbean Health Sciences Literature (LILACS; Bireme); and Conference Proceedings Citation Index-Science (CPCI-S) on the Web of Science (Clarivate Analytics) on 10 January 2020. We searched for ongoing trials from ClinicalTrials.gov, Clinical-trials.com, and the World Health Organization International Clinical Trials Registry Platform on 15 May 2020. SELECTION CRITERIA: We included randomised controlled trials that compared exercise-based CR interventions with no exercise training. Trial participants comprised adults aged 18 years or older who had undergone heart valve surgery for heart valve disease (from any cause) and had received heart valve replacement or heart valve repair. Both percutaneous and surgical procedures were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. We assessed the risk of systematic errors ('bias') by evaluating risk domains using the 'Risk of bias' (RoB2) tool. We assessed clinical and statistical heterogeneity. We performed meta-analyses using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence for primary outcomes (all-cause mortality, all-cause hospitalisation, and health-related quality of life). MAIN RESULTS: We included six trials with a total of 364 participants who have had open or percutaneous heart valve surgery. For this updated review, we identified four additional trials (216 participants). One trial had an overall low risk of bias, and we classified the remaining five trials as having some concerns. Follow-up ranged across included trials from 3 to 24 months. Based on data at longest follow-up, a total of nine participants died: 4 CR versus 5 control (relative risk (RR) 0.83, 95% confidence interval (CI) 0.26 to 2.68; 2 trials, 131 participants; GRADE quality of evidence very low). No trials reported on cardiovascular mortality. One trial reported one cardiac-related hospitalisation in the CR group and none in the control group (RR 2.72, 95% CI 0.11 to 65.56; 1 trial, 122 participants; GRADE quality of evidence very low). We are uncertain about health-related quality of life at completion of the intervention in CR compared to control (Short Form (SF)-12/36 mental component: mean difference (MD) 1.28, 95% CI -1.60 to 4.16; 2 trials, 150 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD 2.99, 95% CI -5.24 to 11.21; 2 trials, 150 participants; GRADE quality of evidence very low), or at longest follow-up (SF-12/36 mental component: MD -1.45, 95% CI -4.70 to 1.80; 2 trials, 139 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD -0.87, 95% CI -3.57 to 1.83; 2 trials, 139 participants; GRADE quality of evidence very low).  AUTHORS' CONCLUSIONS: Due to lack of evidence and the very low quality of available evidence, this updated review is uncertain about the impact of exercise-CR in this population in terms of mortality, hospitalisation, and health-related quality of life. High-quality (low risk of bias) evidence on the impact of CR is needed to inform clinical guidelines and routine practice.

Understanding the lived experiences of short- and long-term consequences on daily life after out-of-hospital cardiac arrest. A focus group study.

AIM: To explore and gain in-depth understanding of how out-of-hospital cardiac arrest survivors experience the short- and long-term consequences on daily life. DESIGN: A qualitative exploratory design. METHODS: A purposive sample of 32 survivors of out-of-hospital cardiac arrest. Data from six audiotaped focus group interviews were collected in either November 2018 or in March 2019. Analysis and interpretation of the transcribed texts was performed using a phenomenological-hermeneutic approach guided by Ricoeur for unfolding lived experiences. RESULTS: Three narratives were identified. The survivors narrated how they in the early phase after the cardiac arrest experienced: (a) 'a fragmented memory at the mercy of the system'. The analysis further showed how the participants were: (b) 'living in the shadow of anxiety and mixed feelings' and with the: (c) 'lost sense of self' up to several years after survival. CONCLUSION: The participants in our study experienced distinct bodily impairments, suffering, and the lost sense of self in the return to daily life from early on to several years after resuscitation. There seem to be an urgent need for an early initiated post-arrest transitional care program led by an expert cardiac arrest nurse. In particular, the healthcare professionals need to pay attention to survivors in employment and with children living at home. Facilitated cardiac arrest peer support groups might minimize the long-term suffering, heighten the self-image, and install a new hope for the future. IMPACT: To ease the post-arrest return to daily life for out-of-hospital cardiac arrest survivors it seems important that a transitional care program from the inhospital setting to the community consist of: (a) screening for and education on bodily losses at an early stage, (b) provision of support on the often prolonged emotional reactions, and (c) referring for further individual and targeted psychological and neurological follow-up and rehabilitation if needed.

Supplementing prediction by EuroSCORE with social and patient-reported measures among patients undergoing cardiac surgery.

OBJECTIVES: The risk of poor outcomes is traditionally attributed to biological and physiological processes in cardiac surgery. However, evidence exists that other factors, such as emotional, behavioral, social, and functional, are predictive of poor outcomes. Objectives were to evaluate the predictive value of several emotional, social, functional, and behavioral factors on four outcomes: death within 90 days, prolonged stay in intensive care, prolonged hospital admission, and readmission within 90 days following cardiac surgery. METHODS: This prospective study included adults undergoing cardiac surgery 2013-2014, including information on register-based socioeconomic factors and self-reported health in a nested subsample. Logistic regression analyses to determine the association and incremental value of each candidate predictor variable were conducted. Multiple regression analyses were used to determine the incremental value of each candidate predictor variable, as well as discrimination and calibration based on the area under the curve (AUC) and Brier score. RESULTS: Of 3217 patients, 3% died, 9% had prolonged intensive care stay, 51% had prolonged hospital admission, and 39% were readmitted to hospital. Patients living alone (odds ratio, 1.19; 95% confidence interval, 1.02-1.38), with lower educational levels (1.27; 1.04-1.54) and low health-related quality of life (1.43; 1.02-2.01) had prolonged hospital admission. Analyses revealed living alone as predictive of prolonged intensive care unit (ICU) stay (Brier, 0.08; AUC, 0.68), death (0.03; 0.71), and prolonged hospital admission (0.24; 0.62). CONCLUSION: Living alone was found to supplement EuroSCORE in predicting death, prolonged hospital admission, and prolonged ICU stay following cardiac surgery. Low educational level and impaired health-related quality of life were, furthermore, predictive of prolonged hospital admission.

Association between frailty and self-reported health following heart valve surgery.

BACKGROUND: Knowledge about the association between frailty and self-reported health among patients undergoing heart valve surgery remains sparse. Thus, the objectives were to I) describe changes in self-reported health at different time points according to frailty status, and to II) investigate the association between frailty status at discharge and poor self-reported health four weeks after discharge among patients undergoing heart valve surgery. METHODS: In a prospective cohort study, consecutive patients undergoing heart valve surgery, including transapical/transaortic valve procedures were included. Frailty was measured using the Fried score, and self-reported health using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQoL-5 Dimensions 5-Levels Health Status Questionnaire (EQ-5D-5L).To investigate the association between frailty and self-reported health, multivariable logistic regression models were used. Analyses were adjusted for sex, age, surgical risk evaluation (EuroScore) and procedure and presented as odds ratios (OR) with 95% confidence intervals (CI). RESULTS: Frailty was assessed at discharge in 288 patients (median age 71, 69% men); 51 patients (18%) were frail. In the multivariable analyses, frailty at discharge remained significantly associated with poor self-reported health at four weeks, OR (95% CI): EQ-5D-5L Index 3.38 (1.51-7.52), VAS 2.41 (1.13-5.14), and KCCQ 2.84 (1.35-5.97). CONCLUSION: Frailty is present at discharge in 18% of patients undergoing heart valve surgery, and being frail is associated with poor self-reported health at four weeks of follow-up. This supports a clinical need to address the unique risk of frail patients among heart valve teams broadly, and not only to measure frailty as a marker of operative risk.

Employment status before and after open heart valve surgery: A cohort study.

OBJECTIVE: Detachment from the workforce following open heart valve surgery is a burden for the patient and society. The objectives were to examine patterns of employment status at different time points and to investigate factors associated with a lower likelihood of returning to the workforce within six months. METHODS: A cohort study of patients aged 18-63 undergoing valvular surgery at a Danish tertiary centre from 2013-2017. Return to the workforce was defined as being employed, unemployed (still capable of working) or receiving paid leave of absence. The association between demographic-, clinical characteristics (including a surgical risk evaluation, EuroScore), and return to the workforce were investigated with a multivariable logistic regression model. RESULTS: In total, 1,395 consecutive patients underwent surgery, 347 were between 18 and 63 years and eligible for inclusion. Of those, 282 were attached to the workforce before surgery and included in the study. At the time of surgery, 79% were on paid sick leave. After six months, 21% of the patients (being part of the workforce before surgery), were still on sick leave. In the regression model, prolonged sick leave prior to surgery (OR 0.43, 95% CI 0.23-0.79) and EuroScore ≥ 2.3 (OR 0.39, 95% CI 0.21-0.74) significantly reduced the likelihood of returning to the workforce. CONCLUSION: One-fifth of patients in the working-age were on sick leave six months after surgery. Prolonged sick leave prior to surgery and a EuroScore ≥2.3 were associated with a lower likelihood of returning to the workforce.

Predictors of patient-reported outcomes at discharge in patients with heart failure.

BACKGROUND: It is well-established that heart failure has a negative impact on quality of life. However, little is known about patient-related predictors of health-related quality of life, anxiety and depression, symptoms and illness perception among patients with heart failure. AIM: To study the association between patient-related predictors and patient-reported outcome measures at discharge from hospital in a cohort of patients with heart failure. METHODS: We used data from 1506 patients with heart failure, participating in the national DenHeart Survey of patient-reported outcome measures in patients with heart disease. The potential patient-related predictors included demographic, administrative, clinical and socioeconomic factors. The patient-reported outcome measures included six questionnaires: the Short Form-12, the Hospital Anxiety and Depression Scale, the EuroQol five-dimensional, five-level questionnaire, the HeartQoL, the Brief Illness Perception Questionnaire and the Edmonton Symptom Assessment Scale. Data were linked to national patient registry data and medical records. We performed multivariable linear and logistic regression analyses. RESULTS: In adjusted linear regression analyses we found that a length of hospital stay of >2 days was associated with worse scores across questionnaires, except for the Brief Illness Perception Questionnaire. Higher comorbidity level was associated with worse scores across all questionnaires, whereas low social support was associated with worse scores across questionnaires, except for the physical domain of the Short Form-12 and the HeartQoL global score. CONCLUSIONS: This study identified length of hospital stay > 2 days, a higher comorbidity level and low social support to be associated with worse scores across questionnaires at discharge from a cardiac-related hospitalisation in patients with heart failure.

Educational inequality in patient-reported outcomes but not mortality among cardiac patients: Results from the national DenHeart survey with register follow-up.

Aims: This study aimed to explore whether educational level is associated with mental and physical health status, anxiety and depression symptoms and quality of life at hospital discharge and predicts cardiac events and all-cause mortality 1 year after hospital discharge in patients with ischaemic heart disease, arrhythmias, heart failure or heart valve disease. Methods: The DenHeart survey is cross-sectional and combined with data from national registers. Information on educational level and co-morbidity at hospital discharge and cardiac events and mortality 1-year post-discharge was obtained from registers. Patient-reported outcomes included SF-12, Hospital Anxiety and Depression Scale and HeartQoL. Multivariate linear and logistic regression and Cox proportional hazards regression models were used. Results: A total of 13,145 patients were included. A significant educational gradient was found in patient-reported mental and physical health status, anxiety and depression symptoms and quality of life, with lower educational groups reporting worse outcomes in adjusted analyses. No association was found between educational level and risk of cardiac events or all-cause mortality within 1 year after hospital discharge in adjusted analyses. Conclusions: In a large population of patients with cardiac disease a significant educational gradient was found in mental and physical health and quality of life at hospital discharge. There was, however, no association between educational level and risk of cardiac events or mortality 1 year after hospital discharge.

The challenge of non-adherence to early rehabilitation after coronary artery bypass surgery: Secondary results from the SheppHeartCABG trial.

BACKGROUND: Attending and maintaining a cardiac rehabilitation programme is a challenge. AIMS: The purpose of this study was to explore associations between non-adherence to early coronary artery bypass graft rehabilitation and sociodemographic and clinical baseline data. METHODS: Coronary artery bypass graft patients were randomised 1:1 to either four weeks of comprehensive early rehabilitation or usual care. Outcomes were assessed at three time-points points: baseline, discharge and four weeks post-coronary artery bypass graft. Differences in sociodemographic and clinical baseline data in adherent versus non-adherent patients were tested using the Pearson χ2 test for categorical variables. To test associations between non-adherence to exercise training and sociodemographic and clinical baseline data, multivariate logistic regression was used to estimate the odds ratio for in-hospital training and post-discharge training adjusted for age, sex and left ventricular ejection fraction. RESULTS: Non-adherence to in-hospital versus post-discharge exercise training was 31% (n=48) versus 53% (n=81). Female non-adherence was 20% versus 70%. Non-adherence to in-hospital versus post-discharge mindfulness was 87% versus 70%. Male non-adherence to mindfulness was 85% versus 70%. Non-adherence to psycho-educational consultations was 3%, most of whom were men. Patients with university level education were more adherent to in-hospital exercise training than patients with lower educational level (odds ratio=3.14 (95% confidence interval; 1.16-8.51), p=0.02). Diabetic patients were more non-adherent to exercise training after discharge (3.74 (1.54-9.08), p=0.004) as were overweight patients (0.37 (0.17-0.80), p=0.01). CONCLUSIONS: This study demonstrated wide acceptance of psycho-educational consultations in post-coronary artery bypass graft patients. Adherence to physical rehabilitation was low especially after discharge from hospital and the opportunity to attend a mindfulness programme was not used.

Cognitive behavioural therapy significantly reduces anxiety in patients with implanted cardioverter defibrillator compared with usual care: Findings from the Screen-ICD randomised controlled trial.

AIM: The aim of this study was to investigate the effect of a cognitive behavioural therapy intervention provided by trained cardiac nurses plus usual care compared with usual care alone in patients with an implanted cardioverter defibrillator who, prior to randomization, had presented with symptoms of anxiety measured by the Hospital Anxiety and Depression Scale. BACKGROUND: Around 20-25% of all patients with an implanted cardioverter defibrillator experience anxiety. Among these patients anxiety is associated with mortality, presumably explained by risk behaviour and activation of the autonomic nervous system. We hypothesised that cognitive behavioural therapy provided by cardiac nurses in an out-patient setting would be an effective treatment of anxiety. METHODS: This was an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive behavioural therapy plus usual care or to usual care. The primary outcome was Hospital Anxiety and Depression Scale-Anxiety mean score at 16 weeks. Secondary outcomes included Hospital Anxiety and Depression Scale-Depression, Becks Anxiety Inventory, HeartQoL and Hamilton Anxiety Scale. Primary outcome analysis was based on the intention-to-treat principle. RESULTS: A total of 88 participants were included, 66% men, mean age 64.3 years and 61% had primary indication implantable cardioverter defibrillator. A significant difference after 16 weeks was found between groups: intervention group (Hospital Anxiety and Depression Scale-A mean (standard deviation) 4.95 points (3.30) versus usual care group 8.98 points (4.03) (p < 0.0001)). Cohen's d was -0.86, indicating a strong clinical effect. The effect was supported by secondary outcomes. CONCLUSION: Cognitive behavioural therapy provided by cardiac nurses to patients with a positive screening for anxiety had a statistically and clinically significant effect on anxiety compared with patients not receiving cognitive behavioural therapy.

Exercise-based cardiac rehabilitation for adult patients with an implantable cardioverter defibrillator.

BACKGROUND: An effective way of preventing sudden cardiac death is the use of an implantable cardioverter defibrillator (ICD). In spite of the potential mortality benefits of receiving an ICD device, psychological problems experienced by patients after receiving an ICD may negatively impact their health-related quality of life, and lead to increased readmission to hospital and healthcare needs, loss of productivity and employment earnings, and increased morbidity and mortality. Evidence from other heart conditions suggests that cardiac rehabilitation should consist of both exercise training and psychoeducational interventions; such rehabilitation may benefit patients with an ICD. Prior systematic reviews of cardiac rehabilitation have excluded participants with an ICD. A systematic review was therefore conducted to assess the evidence for the use of exercise-based intervention programmes following implantation of an ICD. OBJECTIVES: To assess the benefits and harms of exercise-based cardiac rehabilitation programmes (exercise-based interventions alone or in combination with psychoeducational components) compared with control (group of no intervention, treatment as usual or another rehabilitation programme with no physical exercise element) in adults with an ICD. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and four other databases on 30 August 2018 and three trials registers on 14 November 2017. We also undertook reference checking, citation searching and contacted study authors for missing data. SELECTION CRITERIA: We included randomised controlled trials (RCTs) if they investigated exercise-based cardiac rehabilitation interventions compared with no intervention, treatment as usual or another rehabilitation programme. The trial participants were adults (aged 18 years or older), who had been treated with an ICD regardless of type or indication. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias. The primary outcomes were all-cause mortality, serious adverse events and health-related quality of life. The secondary outcomes were exercise capacity, antitachycardia pacing, shock, non-serious adverse events, employment or loss of employment and costs and cost-effectiveness. Risk of systematic errors (bias) was assessed by evaluation of predefined bias risk domains. Clinical and statistical heterogeneity were assessed. Meta-analyses were undertaken using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence. MAIN RESULTS: We identified eight trials published from 2004 to 2017 randomising a total of 1730 participants, with mean intervention duration of 12 weeks. All eight trials were judged to be at overall high risk of bias and effect estimates are reported at the end of the intervention with a follow-up range of eight to 24 weeks.Seven trials reported all-cause mortality, but deaths only occurred in one trial with no evidence of a difference between exercise-based cardiac rehabilitation and control (risk ratio (RR) 1.96, 95% confidence interval (CI) 0.18 to 21.26; participants = 196; trials = 1; quality of evidence: low). There was also no evidence of a difference in serious adverse events between exercise-based cardiac rehabilitation and control (RR 1.05, 95% CI 0.77 to 1.44; participants = 356; trials = 2; quality of evidence: low). Due to the variation in reporting of health-related quality of life outcomes, it was not possible to pool data. However, the five trials reporting health-related quality of life at the end of the intervention, each showed little or no evidence of a difference between exercise-based cardiac rehabilitation and control.For secondary outcomes, there was evidence of a higher pooled exercise capacity (peak VO2) at the end of the intervention (mean difference (MD) 0.91 mL/kg/min, 95% CI 0.60 to 1.21; participants = 1485; trials = 7; quality of evidence: very low) favouring exercise-based cardiac rehabilitation, albeit there was evidence of substantial statistical heterogeneity (I2 = 78%). There was no evidence of a difference in the risk of requiring antitachycardia pacing (RR 1.26, 95% CI 0.84 to 1.90; participants = 356; trials = 2; quality of evidence: moderate), appropriate shock (RR 0.56, 95% CI 0.20 to 1.58; participants = 428; studies = 3; quality of evidence: low) or inappropriate shock (RR 0.60, 95% CI 0.10 to 3.51; participants = 160; studies = 1; quality of evidence: moderate). AUTHORS' CONCLUSIONS: Due to a lack of evidence, we were unable to definitively assess the impact of exercise-based cardiac rehabilitation on all-cause mortality, serious adverse events and health-related quality of life in adults with an ICD. However, our findings do provide very low-quality evidence that patients following exercise-based cardiac rehabilitation experience a higher exercise capacity compared with the no exercise control. Further high-quality randomised trials are needed in order to assess the impact of exercise-based cardiac rehabilitation in this population on all-cause mortality, serious adverse events, health-related quality of life, antitachycardia pacing and shock.

Patient-reported outcomes are independent predictors of one-year mortality and cardiac events across cardiac diagnoses: Findings from the national DenHeart survey.

AIMS: Patient-reported quality of life and anxiety/depression scores provide important prognostic information independently of traditional clinical data. The aims of this study were to describe: (a) mortality and cardiac events one year after hospital discharge across cardiac diagnoses; (b) patient-reported outcomes at hospital discharge as a predictor of mortality and cardiac events. DESIGN: A cross-sectional survey with register follow-up. METHODS: Participants: All patients discharged from April 2013 to April 2014 from five national heart centres in Denmark. MAIN OUTCOMES: Patient-reported outcomes: anxiety and depression (Hospital Anxiety and Depression Scale); perceived health (Short Form-12); quality of life (HeartQoL and EQ-5D); symptom burden (Edmonton Symptom Assessment Scale). Register data: mortality and cardiac events within one year following discharge. RESULTS: There were 471 deaths among the 16,689 respondents in the first year after discharge. Across diagnostic groups, patients reporting symptoms of anxiety had a two-fold greater mortality risk when adjusted for age, sex, marital status, educational level, comorbidity, smoking, body mass index and alcohol intake (hazard ratio (HR) 1.92, 95% confidence interval (CI) 1.52-2.42). Similar increased mortality risks were found for patients reporting symptoms of depression (HR 2.29, 95% CI 1.81-2.90), poor quality of life (HR 0.46, 95% CI 0.39-0.54) and severe symptom distress (HR 2.47, 95% CI 1.92-3.19). Cardiac events were predicted by poor quality of life (HR 0.71, 95% CI 0.65-0.77) and severe symptom distress (HR 1.58, 95% CI 1.35-1.85). CONCLUSIONS: Patient-reported mental and physical health outcomes are independent predictors of one-year mortality and cardiac events across cardiac diagnoses.

Sociodemographic, Clinical and Patient-Reported Outcomes and Readmission After Heart Valve Surgery.

BACKGROUND: Readmissions after heart valve surgery represent a significant burden for both the patient and the healthcare system. The study aim was to identify independent predictors of readmission within 180 days after surgery in a population of patients undergoing heart valve surgery. METHODS: Demographic and clinical information was obtained from national registers. Patient-reported outcomes (PROs) including Short Form 12 (SF-12) and EuroQol 5D (EQ-5D) were measured at discharge as part of a national, cross-sectional study (DenHeart). Predictors of first readmission were investigated. RESULTS: Among a total of 1,084 patients (65% men; mean age 68 years; 354 responded to questionnaires), 534 (49%) were readmitted. Responding patients who were readmitted were younger and a greater proportion had undergone mitral valve surgery. A significantly higher proportion of non-responders was readmitted. No significant differences were found in PROs between patients readmitted and those not readmitted, and receiver operating characteristic (ROC) curves showed no predictive effect of SF-12 and EQ-5D. Survival analysis using Cox proportional hazard models showed that prior percutaneous coronary intervention (PCI) (HR 1.50, CI 1.10; 2.05, p = 0.010) and a history of heart failure (HR 1.37, CI 1.10; 1.72, p = 0.006) were predictive of readmission. CONCLUSIONS: Readmission rates after heart valve surgery are high and often seen in patients who have undergone PCI and heart failure before surgery. Predictors for these high readmissions rates are difficult to establish based on medical history and type of surgery. PROs at discharge contribute information regarding a patient's perception of their often poor quality of life, but do not predict readmission.

Patient-reported outcomes after aortic and mitral valve surgery - results from the DenHeart Study.

BACKGROUND: Clinical course, co-morbidity and age often differs between patients undergoing aortic and mitral valve surgery and this might affect patient-reported outcomes. AIMS: The purpose of this study was to describe differences in patient-reported physical and mental health and health-related quality of life after aortic valve or mitral valve surgery, and to identify demographic and clinical characteristics associated with worse patient-reported physical and mental health, and health-related quality of life. METHODS: Patient-reported outcomes were measured at discharge as a part of a national, cross-sectional study (DenHeart). Patient-reported outcome measures included: Short-Form-12, Hospital Anxiety and Depression Scale, EuroQol-5D-5L, HeartQol and Edmonton Symptom Assessment System. Demographic and clinical information was obtained from national registers. RESULTS: Of 354 patients (65% men, mean age: 68 years), 79% underwent aortic valve surgery. Patients who had undergone aortic valve surgery had more symptoms of anxiety compared with patients who had undergone mitral valve surgery (34% vs 17%, p=0.003, Hospital Anxiety and Depression Scale anxiety cut-off score of eight). Being female was associated with worse patient-reported outcomes on all measures, whereas being unmarried was associated with worse physical health (Physical Component Score Short-Form-12) and symptom burden (Edmonton Symptom Assessment System). Length of stay was associated with worse symptoms on EuroQol-5D-5L Visual Analogue Scale. Age and comorbidity were not associated with patient-reported outcomes. CONCLUSION: Patients who had undergone aortic valve and mitral valve surgery did not significantly differ in patient-reported health at discharge, except for symptoms of anxiety. Being female was the only characteristic associated with overall worse patient-reported outcomes at discharge.

Patient perceptions of experience with cardiac rehabilitation after isolated heart valve surgery.

BACKGROUND: Little evidence exists on whether cardiac rehabilitation is effective for patients after heart valve surgery. Yet, accepted recommendations for patients with ischaemic heart disease continue to support it. To date, no studies have determined what heart valve surgery patients prefer in a cardiac rehabilitation programme, and none have analysed their experiences with it. AIMS: The purpose of this qualitative analysis was to gain insight into patients' experiences in cardiac rehabilitation, the CopenHeartVR trial. This trial specifically assesses patients undergoing isolated heart valve surgery. METHODS: Semi-structured interviews were conducted with nine patients recruited from the intervention arm of the trial. The intervention consisted of a physical training programme and a psycho-educational intervention. Participants were interviewed three times: 2-3 weeks, 3-4 months and 8-9 months after surgery between April 2013 and October 2014. Data were analysed using qualitative thematic analysis. RESULTS: Participants had diverse needs and preferences. Two overall themes emerged: cardiac rehabilitation played an important role in (i) reducing insecurity and (ii) helping participants to take active personal responsibility for their health. Despite these benefits, participants experienced existential and psychological challenges and musculoskeletal problems. Participants also sought additional advice from healthcare professionals both inside and outside the healthcare system. CONCLUSIONS: Even though the cardiac rehabilitation programme reduced insecurity and helped participants take active personal responsibility for their health, they experienced existential, psychological and physical challenges during recovery. The cardiac rehabilitation programme had several limitations, having implications for designing future programmes.

Exercise-based cardiac rehabilitation for adults with atrial fibrillation.

BACKGROUND: Exercise-based cardiac rehabilitation may benefit adults with atrial fibrillation or those who had been treated for atrial fibrillation. Atrial fibrillation is caused by multiple micro re-entry circuits within the atrial tissue, which result in chaotic rapid activity in the atria. OBJECTIVES: To assess the benefits and harms of exercise-based rehabilitation programmes, alone or with another intervention, compared with no-exercise training controls in adults who currently have AF, or have been treated for AF. SEARCH METHODS: We searched the following electronic databases; CENTRAL and the Database of Abstracts of Reviews of Effectiveness (DARE) in the Cochrane Library, MEDLINE Ovid, Embase Ovid, PsycINFO Ovid, Web of Science Core Collection Thomson Reuters, CINAHL EBSCO, LILACS Bireme, and three clinical trial registers on 14 July 2016. We also checked the bibliographies of relevant systematic reviews identified by the searches. We imposed no language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCT) that investigated exercise-based interventions compared with any type of no-exercise control. We included trials that included adults aged 18 years or older with atrial fibrillation, or post-treatment for atrial fibrillation. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data. We assessed the risk of bias using the domains outlined in the Cochrane Handbook for Systematic Reviews of Interventions. We assessed clinical and statistical heterogeneity by visual inspection of the forest plots, and by using standard Chi² and I² statistics. We performed meta-analyses using fixed-effect and random-effects models; we used standardised mean differences where different scales were used for the same outcome. We assessed the risk of random errors with trial sequential analysis (TSA) and used the GRADE methodology to rate the quality of evidence, reporting it in the 'Summary of findings' table. MAIN RESULTS: We included six RCTs with a total of 421 patients with various types of atrial fibrillation. All trials were conducted between 2006 and 2016, and had short follow-up (eight weeks to six months). Risks of bias ranged from high risk to low risk.The exercise-based programmes in four trials consisted of both aerobic exercise and resistance training, in one trial consisted of Qi-gong (slow and graceful movements), and in another trial, consisted of inspiratory muscle training.For mortality, very low-quality evidence from six trials suggested no clear difference in deaths between the exercise and no-exercise groups (relative risk (RR) 1.00, 95% confidence interval (CI) 0.06 to 15.78; participants = 421; I² = 0%; deaths = 2). Very low-quality evidence from five trials suggested no clear difference between groups for serious adverse events (RR 1.01, 95% CI 0.98 to 1.05; participants = 381; I² = 0%; events = 8). Low-quality evidence from two trials suggested no clear difference in health-related quality of life for the Short Form-36 (SF-36) physical component summary measure (mean difference (MD) 1.96, 95% CI -2.50 to 6.42; participants = 224; I² = 69%), or the SF-36 mental component summary measure (MD 1.99, 95% CI -0.48 to 4.46; participants = 224; I² = 0%). Exercise capacity was assessed by cumulated work, or maximal power (Watt), obtained by cycle ergometer, or by six minute walking test, or ergospirometry testing measuring VO2 peak. We found moderate-quality evidence from two studies that exercise-based rehabilitation increased exercise capacity, measured by VO2 peak, more than no exercise (MD 3.76, 95% CI 1.37 to 6.15; participants = 208; I² = 0%); and very low-quality evidence from four studies that exercise-based rehabilitation increased exercise capacity more than no exercise, measured by the six-minute walking test (MD 75.76, 95% CI 14.00 to 137.53; participants = 272; I² = 85%). When we combined the different assessment tools for exercise capacity, we found very low-quality evidence from six trials that exercise-based rehabilitation increased exercise capacity more than no exercise (standardised mean difference (SMD) 0.86, 95% CI 0.46 to 1.26; participants = 359; I² = 65%). Overall, the quality of the evidence for the outcomes ranged from moderate to very-low. AUTHORS' CONCLUSIONS: Due to few randomised patients and outcomes, we could not evaluate the real impact of exercise-based cardiac rehabilitation on mortality or serious adverse events. The evidence showed no clinically relevant effect on health-related quality of life. Pooled data showed a positive effect on the surrogate outcome of physical exercise capacity, but due to the low number of patients and the moderate to very low-quality of the underpinning evidence, we could not be certain of the magnitude of the effect. Future high-quality randomised trials are needed to assess the benefits and harms of exercise-based cardiac rehabilitation for adults with atrial fibrillation on patient-relevant outcomes.

Is the Cardiovascular Response Equivalent Between a Supervised Center-Based Setting and a Self-care Home-Based Setting When Rating of Perceived Exertion Is Used to Guide Aerobic Exercise Intensity During a Cardiac Rehabilitation Program?

OBJECTIVES: The aim of this study was to investigate if exercise intensity guided by rating of perceived exertion (RPE) results in an equivalent cardiovascular response when applied in either a center-based or a home-based setting. DESIGN: Data from patients with heart disease (post-valve surgery and atrial fibrillation post-radiofrequency ablation) participating in exercise-based rehabilitation were included. Patients performed a 12-week program in either a center- or a home-based setting. Using RPE, patients recorded their exercise intensity 3 times during an aerobic training phase. Exercise intensity was objectively measured using heart rate (HR) monitors. RESULTS: A total of 2622 RPE values with corresponding HR data were available. There was no difference in the level of association (interaction P = 0.51) between HR and RPE seen in the center-based setting (mean of 6.1 beats/min per 1.0 difference in RPE; 95% confidence interval, 4.8-7.5 beats/min) compared with the home-based setting (mean of 5.3 beats/min per 1.0 difference in RPE; 95% confidence interval, 4.0-6.5 beats/min). The level of patient familiarization, exercise intensity, and patient characteristics did not affect the level of association between RPE and HR. CONCLUSIONS: Independent of exercise setting, RPE appears to be equally effective in guiding exercise intensity of patients participating in cardiac rehabilitation.