Are cardiac rehabilitation pathways influenced by diabetes: A cohort study.

BACKGROUND: Cardiac rehabilitation (CR) is recommended following acute coronary syndrome (ACS). Diabetes is a common long-term condition associated with ACS, and the inclusion of these patients in CR has been less studied. This study examines the referral, uptake, and completion rates in the CR pathway for ACS patients with and without diabetes to identify potential barriers in the CR pathway. METHODS: The study included patients aged 18 or above who were discharged after a diagnosis of ACS in the Central Denmark Region between 1 September 2017 and 31 August 2018. Diabetes information was obtained from three sources. Logistic regression models were used to examine the associations between having diabetes and the three outcomes: non-referral, non-uptake and non-completion. Results were reported as odds ratios (OR) with 95% confidence intervals (CI). RESULTS: A total of 2447 patients were eligible for the study, of which 457 (18.7%) had diabetes. Only non-uptake was found to be significantly associated with diabetes after adjustment for prespecified variables (OR = 1.38, 95% CI 1.01-1.90). Associations for non-referral (OR = 1.11, 95% CI 0.87-1.41) and non-completion (OR = 1.06, 95 %CI 0.73-1.53) were not found to be statistically significant between ACS patients with diabetes and those without diabetes. CONCLUSION: This study highlights a significant disparity in the uptake of CR between patients with and without diabetes following ACS, demonstrating that patients with diabetes require early promotion and increased assistance to enrol in CR.

Psychometric Properties of the Kansas City Cardiomyopathy Questionnaire in a Surgical Population of Patients With Aortic Valve Stenosis.

The 12-item version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) was originally developed for patients with heart failure but has been used and tested among patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation. Whether the instrument is suitable for patients with AS who underwent surgical aortic valve replacement (SAVR) is currently unknown. Thus, we aimed to investigate the psychometric properties of the KCCQ-12 before and after SAVR among patients with severe AS. We conducted a prospective cohort of 184 patients with AS who completed the KCCQ-12 and the EuroQol 5 Dimension 5 Levels before and 4 weeks after surgery. Construct validity was investigated with hypothesis testing and an analysis of Spearman's correlation between the two instruments. Structural validity was investigated with explorative and confirmatory factor analyses and reliability with Cronbach's α. All analyses were conducted on data from the two time points (preoperatively and four weeks after surgery). The hypothesis testing revealed how the New York Heart Association class was significantly correlated with the preoperative KCCQ-12 total score (higher New York Heart Association class, worse score). A longer length of hospital stay and living alone were significantly associated with poorer postoperative KCCQ-12 total score. KCCQ-12 and EuroQol 5 Dimension 5 Levels were moderately correlated in most domains/the total score/Visual Analogue Scale score. Principal component analyses revealed two 3-factor structures. The confirmatory factor analyses did not support the original model at any time point. Cronbach's α ranged from 0.22 to 0.84 in three preoperative factors and from 0.39 to 0.76 in the postoperative factors. The total Cronbach's α was 0.83 for the suggested preoperative 3-factor model and 0.83 for the postoperative model. In conclusion, the Danish version of the KCCQ-12 tested in a population of patients with AS who underwent SAVR appears to have acceptable construct validity, whereas structural validity cannot be confirmed for the original four-factor model. Overall reliability is good.

Cognitive-behavioural therapy reduces psychological distress in younger patients with cardiac disease: a randomized trial.

AIMS: To test whether usual outpatient cardiac rehabilitation (CR) supplemented by a cognitive-behavioural therapy (CBT) intervention may reduce anxiety and depression compared with usual CR. METHODS AND RESULTS: In this multicentre randomized controlled trial, 147 cardiac patients (67% men, mean age 54 years, 92% with coronary artery disease) with psychological distress defined as a hospital anxiety and depression scale (HADS) anxiety or depression score ≥8 were randomized to five sessions of group CBT plus usual CR (intervention, n = 74) or CR alone (control, n = 73). Patients with severe distress or a psychiatric diagnosis were excluded. The intervention was delivered by cardiac nurses with CBT training and supervised by a psychologist. A reference, non-randomized group (background, n = 41) of consecutive patients without psychological distress receiving usual CR was included to explore the effect of time on HADS score. The primary outcome, total HADS score after 3 months, improved more in the intervention than in the control group [the mean total HADS score improved by 8.0 (standard deviation 5.6) vs. 4.1 (standard deviation 7.8), P < 0.001]. Significant between-group differences were maintained after 6 months. Compared with the control group, the intervention group also had greater adherence to CR (P = 0.003), more improvement in the heart-related quality of life (HeartQoL) at 6 months (P < 0.01), and a significant reduction in cardiac readmissions at 12 months (P < 0.01). The background group had no significant change in HADS score over time. CONCLUSION: Brief CBT provided by cardiac nurses in relation to CR reduced anxiety and depression scores, improved HeartQoL and adherence to CR, and reduced cardiovascular readmissions. The programme is simple and may be implemented by CR nurses.

Socioeconomic and ethnical disparity in coronary heart disease outcomes in Denmark and the effect of cardiac rehabilitation-A nationwide registry study.

AIMS: Cardiovascular patients with low socioeconomic status and non-western ethnic background have worse prognostic outcomes. The aim of this nationwide study was first to address whether short-term effects of hospital-based outpatient cardiac rehabilitation (CR) are similar across educational level and ethnic background, and secondly to study whether known disparity in long-term prognosis in patients with cardiovascular disese is diminished by CR participation. METHODS: All patients with myocardial infarction and/or coronary revascularization from August 2015 until March 2018 in the Danish national patient registry or the Danish cardiac rehabilitation database (DHRD) were included. We used descriptive statistics to address disparity in achievement of quality indicators in CR, and Cox proportional hazard regression to examine the association between the disparity measures and MACE (cardiovascular hospitalization and all-cause mortality) with adjustment for age, gender, index-diagnose and co-morbidity. RESULTS: We identified 34,511 patients of whom 19,383 had participated in CR and 9,882 provided information on CR outcomes from the DHRD. We demonstrated a socioeconomic gradient in improvements in VO2peak, and non-western patients were less often screened for depression or receive dietary consulting. We found a strong socioeconomic gradient in MACE irrespective of CR participation, medication, and risk factor control (adjusted HR 0.65 (95% CI 0.56-0.77) for high versus low education). Non-western origin was associated with higher risk of MACE (adjusted HR 1.2 (1.1-1.4)). CONCLUSION: We found only minor socioeconomic and ethnic differences in achievement of CR quality indicators but strong differences in CHD prognosis indication that conventional risk factor control and medical treatment following CR do not diminish the socioeconomic and ethnical disparity in CHD prognosis.

Occurrence and predictors of pericardial effusion requiring invasive treatment following heart valve surgery.

OBJECTIVES: To describe the occurrence of significant pericardial effusion, and to investigate characteristics associated with pericardial effusion within three months following heart valve surgery. METHODS: A retrospective, observational cohort study including adult patients undergoing heart valve surgery at Odense University Hospital from August 2013 to November 2017. Data were gathered from The Western Denmark Heart Registry and electronic patient records.Cox proportional hazard models were used to investigate the associations between characteristics associated with significant pericardial effusion during index admission and within 3 months. Results are presented as HR with 95% CI. RESULTS: In total, 1460 patients were included (70% men, median age 71 years (IQR 63-76)) and of those, n=230 patients (16%) developed significant pericardial effusion.EuroScore II was significantly associated with an increased risk of pericardial effusion during index admission and associated with a lower risk following discharge (index admission HR 1.05, 95% CI 1.02 to 1.08, after discharge HR 0.80, 95% CI 0.69 to 0.92). Increasing age (HR 0.97, 95% CI 0.95 to 0.98 per year) and concomitant coronary artery bypass grafting versus isolated valve surgery (HR 0.58, 95% CI 0.35 to 0.97) were significantly associated with a reduced risk of pericardial effusions in both periods. Being a man (HR 2.30, 95% CI 1.32 to 4.01) and aortic valve disease versus mitral valve disease (HR 2.16, 95% CI 1.20 to 3.90) were significantly associated with an increased risk after discharge. CONCLUSION: Significant pericardial effusions requiring drainage were present in 16% of cases following heart valve surgery, and different clinical characteristics were associated with the development of effusion.

Cardiac rehabilitation for patients with heart failure: association with readmission and mortality risk.

AIMS: To examine the temporal trends and factors associated with national cardiac rehabilitation (CR) referral and compare the risk of hospital readmission and mortality in those referred for CR versus no referral. METHODS AND RESULTS: This cohort study includes all adult patients alive 120 days from incident heart failure (HF) identified by the Danish Heart Failure Registry (n = 33 257) between 2010 and 2018. Multivariable logistic regression models were used to assess the association between CR referral and patient factors and acute all-cause hospital readmission and mortality at 1 year following HF admission. Overall, 46.7% of HF patients were referred to CR, increasing from 31.7% in 2010 to 52.2% in 2018. Several factors were associated with lower odds of CR referral: male sex [odds ratio (OR): 0.85; 95% confidence interval: 0.80-0.89], older age, unemployment, retirement, living alone, non-Danish ethnic origin, low educational level, New York Heart Association (NYHA) class IV vs. I (OR: 0.75; 0.60-0.95), left ventricular ejection fraction >40%, and comorbidity (stroke, chronic kidney disease, atrial fibrillation/flutter, and diabetes). Myocardial infarction, arthritis, coronary artery bypass grafting, percutaneous coronary intervention, valvular surgery, NYHA class II, and use of angiotensin-converting enzyme inhibitors were associated with higher odds of CR referral. CR referral was associated with lower risk of acute all-cause readmission (OR: 0.92; 0.87-0.97) and all-cause mortality (OR: 0.65; 0.58-0.72). CONCLUSION: Although increased over time, only one in two HF patients in Denmark were referred to CR in 2018. Strategies are needed to reduce referral disparities, focusing on subgroups of patients at highest risk of non-referral.

Comprehensive cardiac rehabilitation for patients following infective endocarditis: results of the randomized CopenHeartIE trial.

AIMS: Infective endocarditis is a complex and highly mortal disease requiring lengthy treatment. Physical and mental deconditioning is common. Nonetheless, rehabilitation is virtually unexplored in this population. The aim of this trial was therefore to investigate the effects of cardiac rehabilitation in patients following endocarditis. METHODS AND RESULTS: In a randomized trial, adults with left-sided or cardiac device endocarditis were randomized 1:1 to 12 weeks of physical exercise training and five psycho-educational consultations (cardiac rehabilitation) vs. usual care without rehabilitation (control). Primary outcome was mental health measured by SF-36 Mental Component Summary (MCS) at 6 months. Secondary outcome was physical capacity measured by peak oxygen uptake (VO2) at 4 months. Exploratory outcomes were investigated. Low inclusion rate resulted in trial termination before reaching the target sample size. A total of 117 participants (mean age: 60 years, 81% male) were randomized to cardiac rehabilitation (n = 58) or to control (n = 59). Mental health and physical capacity at baseline were generally poor (MCS: 38.9-42.2 points, VO2 peak: 16.1-16.6 mL/kg/min). Cardiac rehabilitation compared with control showed no effect on mental health (MCS: 44.6 points vs. 48.8 points, P = 0.41) or physical capacity (VO2 peak: 19.9 mL/kg/min vs. 18.0 mL/kg/min, P = 0.09). Effects favouring the intervention were identified in exploratory outcomes including general fatigue (P = 0.005), and physical capacity as maximal power (W) (P = 0.005). Adherence to the intervention was 28%. CONCLUSIONS: Results indicate no effect of cardiac rehabilitation in patients following endocarditis; however, lack of statistical power and poor adherence render findings inconclusive. Valuable insight into patients' capabilities and safety was gained, and further investigations into rehabilitation needs and modes of delivery in this high-need population should be a future priority. REGISTRATION: The trial is registered at ClinicalTrials.gov, NCT01512615.

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.

Early follow-up after open heart valve surgery reduces healthcare costs: a propensity matched study.

Objectives: The objective was to assess differences in healthcare costs within 180 days after discharge from open heart valve surgery in an intervention group receiving early, individualised and intensified follow-up compared with a historical control group. Methods: A cost-minimisation analysis comparing costs from a consecutive prospective cohort compared with a propensity matched cohort. Costs related to the intervention, hospital (outpatient visits and readmissions) and general practitioners (all contacts) were included. Data were obtained from electronic patient records and registry data. A logistic propensity model was used to identify the historical control group. Main results are presented as mean differences and 95% CIs based on bootstrapping. Results: After matching, the analysis included 300 patients from the intervention group and 580 controls. The mean intervention cost was €171 (SD 79) per patient. After 180 days, the mean healthcare costs were €1284 (SD 2567) for the intervention group and €2077 (SD 4773) for the controls. The cost of the intervention group was €793 (p<0.001) less per patient. The cost differences were explained mainly by fewer readmissions, fewer overall emergency visits and fewer contacts to the general practitioner during out-of-hours in the intervention group. Conclusions: The intervention consisting of early, individualised and intensified follow-up after open heart valve surgery significantly reduced the healthcare costs within 180 days after discharge.

Data on an intervention to reduce readmissions after open heart valve surgery.

Data describe supplementary tables and figures related to the research article; Effect of early, individualised and intensified follow-up after open heart valve surgery on unplanned cardiac hospital readmissions and all-cause mortality [1]. Data on patients undergoing open heart valve surgery were presented in 308 patients in a prospective cohort and compared with 980 patients in a historical cohort. Included figures show inclusion and exclusion of patients (flowchart) and the specific elements of the intervention. Tables show causes of readmission and sensitivity analyses of differences among patients in the prospective intervention group compared with patients in the historical control group. Further results, interpretation and discussion of the included data can be found in the main research paper.

Effect of early, individualised and intensified follow-up after open heart valve surgery on unplanned cardiac hospital readmissions and all-cause mortality.

BACKGROUND: Unplanned readmissions after heart valve surgery are common, and constitute a significant burden for the patient and the health care system. The objective was to investigate the effect of individualised follow-up after open heart valve surgery on a composite endpoint of first unplanned cardiac hospital readmission or all-cause mortality within 180 days of discharge. METHODS: The study is a prospective cohort study comparing the composite endpoint in patients undergoing early, individualised and intensified follow-up after heart valve surgery with a propensity matched historical control group. A total of 308 consecutive patients were enrolled in the prospective cohort study, 980 consecutive patients comprised the control group. The propensity matched group consisted of n = 300 (intervention) and n = 580 (controls). Time to first event was analysed using uni- and multivariable Cox proportional hazard analysis. Kaplan-Meier survival curves were constructed to assess the probability of survival without readmission. RESULTS: After 180 days, the proportion of patients experiencing the composite endpoint was significantly lower in the intervention group compared with the controls for the overall, unmatched population (23% vs. 38%; HR 0.55; 95% CI, 0.42 to 0.73; P < 0.001). The effect did not change in the propensity matched population (HR 0.57; 95% CI 0.43;0.75, P < 0.001). The difference was related to reduction in readmission rates, whereas death rates were similar in intervention and control group (1.6% vs. 1.8%). CONCLUSION: An intervention consisting of early, individualised and intensified follow-up after open heart valve surgery reduced the risk of a composite endpoint of first, unplanned cardiac hospital readmission or all-cause mortality within 180 days.

Cost-utility analysis of cardiac rehabilitation after conventional heart valve surgery versus usual care.

Background While cardiac rehabilitation in patients with ischaemic heart disease and heart failure is considered cost-effective, this evidence may not be transferable to heart valve surgery patients. The aim of this study was to investigate the cost-effectiveness of cardiac rehabilitation following heart valve surgery. Design We conducted a cost-utility analysis based on a randomised controlled trial of 147 patients who had undergone heart valve surgery and were followed for 6 months. Methods Patients were randomised to cardiac rehabilitation consisting of 12 weeks of physical exercise training and monthly psycho-educational consultations or to usual care. Costs were measured from a societal perspective and quality-adjusted life years were based on the EuroQol five-dimensional questionnaire (EQ-5D). Estimates were presented as means and 95% confidence intervals (CIs) based on bootstrapping. Costs and effect differences were presented in a cost-effectiveness plane and were transformed into net benefit and presented in cost-effectiveness acceptability curves. Results No statistically significant differences were found in total societal costs (-1609 Euros; 95% CI: -6162 to 2942 Euros) or in quality-adjusted life years (-0.000; 95% CI -0.021 to 0.020) between groups. However, approximately 70% of the cost and effect differences were located below the x-axis in the cost-effectiveness plane, and the cost-effectiveness acceptability curves showed that the probability for cost- effectiveness of cardiac rehabilitation compared to usual care is at minimum 75%, driven by a tendency towards costs savings. Conclusions Cardiac rehabilitation after heart valve surgery may not have improved health-related quality of life in this study, but is likely to be cost-effective for society, outweighing the extra costs of cardiac rehabilitation.

Cardiac rehabilitation versus usual care for patients treated with catheter ablation for atrial fibrillation: Results of the randomized CopenHeartRFA trial.

BACKGROUND: To assess the effects of comprehensive cardiac rehabilitation compared with usual care on physical activity and mental health for patients treated with catheter ablation for atrial fibrillation. METHODS: The patients were randomized 1:1 stratified by paroxysmal or persistent atrial fibrillation and sex to cardiac rehabilitation consisting of 12 weeks physical exercise and four psycho-educational consultations plus usual care (cardiac rehabilitation group) versus usual care. The primary outcome was Vo2 peak. The secondary outcome was self-rated mental health measured by the Short Form-36 questionnaire. Exploratory outcomes were collected. RESULTS: 210 patients were included (mean age: 59 years, 74% men), 72% had paroxysmal atrial fibrillation prior to ablation. Compared with usual care, the cardiac rehabilitation group had a beneficial effect on Vo2 peak at four months (24.3mL kg-1 min-1 versus 20.7mL kg-1 min-1, p of main effect=0.003, p of interaction between time and intervention=0.020). No significant difference between groups on Short Form-36 was found (53.8 versus 51.9 points, P=.20). Two serious adverse events (atrial fibrillation in relation to physical exercise and death unrelated to rehabilitation) occurred in the cardiac rehabilitation group versus one in the usual care group (death unrelated to intervention) (P=.56). In the cardiac rehabilitation group 16 patients versus 7 in the usual care group reported non-serious adverse events (P=.047). CONCLUSION: Comprehensive cardiac rehabilitation had a positive effect on physical capacity compared with usual care, but not on mental health. Cardiac rehabilitation caused more non-serious adverse events.

Cardiac rehabilitation patients' perspectives on the recovery following heart valve surgery: a narrative analysis.

AIMS: To explore the structure and content of narratives about the recovery process among patients undergoing heart valve surgery participating in cardiac rehabilitation. BACKGROUND: Several studies with short-term follow-up have shown that recovering from cardiac surgery can be challenging, but evidence on the long-term recovery process is very limited, especially following heart valve surgery. Furthermore, few studies have explored the recovery process among cardiac rehabilitation participants. DESIGN: A qualitative study with serial interviews analysed using narrative methods. METHODS: We collected data over 18 months (April 2013-October 2014). We recruited nine patients undergoing heart valve surgery from a randomized trial, CopenHeartVR and conducted 27 individual narrative interviews at 2-3 weeks, 3-4 months and 8-9 months after surgery. FINDINGS: Following heart valve surgery, the participants expected to return to normality. The analysis identified four courses of recovery, with three non-linear complex pathways deviating from the classic restitution narrative: the frustrated struggle to resume normality, the challenged expectation of normality - being in a limbo and becoming a heart patient. These deviating pathways were characterized by physical, existential and mental challenges even up to 9 months after surgery. CONCLUSION: The recovery processes of participants' in cardiac rehabilitation were often more complicated than anticipated. Patients undergoing heart valve surgery may benefit from more extensive medical follow-up immediately after discharge, individual psychological assessment and individualized, realistic information about the recovery trajectory.

Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising because of an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. The secondary outcome is self-assessed mental health measured by the standardized questionnaire Short Form-36. Long-term healthcare utilization and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design will be used to evaluate qualitative and quantitative findings, encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. CONCLUSION: This randomized clinical trial will contribute with evidence of whether cardiac rehabilitation should be provided after heart valve surgery. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: Trial registered 16 March 2012; ClinicalTrials.gov ( NCT01558765 ).

Patient experiences of recovery after heart valve replacement: suffering weakness, struggling to resume normality.

BACKGROUND: Heart valve disease is becoming a public health problem due to increasing life expectancy and new treatment methods. Patients are at risk of developing depression, anxiety or post-traumatic stress disorder after heart valve surgery. To better plan proper care, describing and understanding patients' perception of recovery after heart valve replacement is essential. The objective was to describe the experience of recovery at home after heart valve replacement. METHODS: Qualitative interviews were conducted with 10 patients representing the population and these were later transcribed. The analysis was inspired by Ricoeur's theory of interpretation, which consists of three levels: naive reading, structured analysis, and critical interpretation and discussion. RESULTS: The overall concept that emerged was suffering weakness and struggling to resume normality. Patients all struggled to resume normal living, both in regaining physical strength and in reestablishing balance in overall living. The overall concept can be interpreted in terms of the following themes: Disturbed network: Invaluable relatives, Contact with healthcare staff, Rehabilitation. Disturbed body: Stressful complications, Bodily attention, Physically affected, Physical capability. Recovery: Interrupted living, Suffering weakness, Gradual recovery, Achieving normality. Reflections: Thoughts about the procedure and Feeling sad and fragile. CONCLUSION: The study presents the main themes of network, body, recovery and reflection for ten patients after heart valve replacement. These main themes can overall be summarized as suffering weakness and struggling to resume normality. Patients felt weak with a changed body, but after a long recovery process regained vitality and returned to their daily life.

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. METHODS: A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. DISCUSSION: The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: ClinicalTrials.gov (http://NCT01558765).

The effect of integrated cardiac rehabilitation versus treatment as usual for atrial fibrillation patients treated with ablation: the randomised CopenHeartRFA trial protocol.

INTRODUCTION: Atrial fibrillation affects almost 2% of the population in the Western world. To preserve sinus rhythm, ablation is undertaken in symptomatic patients. Observational studies show that patients with atrial fibrillation often report a low quality of life and are less prone to be physically active due to fear of triggering fibrillation. Small trials indicate that exercise training has a positive effect on exercise capacity and mental health, and both patients with recurrent atrial fibrillation and in sinus rhythm may benefit from rehabilitation in managing life after ablation. No randomised trials have been published on cardiac rehabilitation for atrial fibrillation patients treated with ablation that includes exercise and psychoeducational components. AIM: To test the effects of an integrated cardiac rehabilitation programme versus treatment as usual for patients with atrial fibrillation treated with ablation. METHODS AND ANALYSIS DESIGN: The trial is a multicentre parallel arm design with 1:1 randomisation to the intervention and control group with blinded outcome assessment. 210 patients treated for atrial fibrillation with radiofrequency ablation will be included. The intervention consists of a rehabilitation programme including four psychoeducative consultations with a specially trained nurse and 12 weeks of individualised exercise training, plus the standard medical follow-up. Patients in the control group will receive the standard medical follow-up. The primary outcome measure is exercise capacity measured by the VO(2) peak. The secondary outcome measure is self-rated mental health measured by the Short Form 36 questionnaire. Postintervention, qualitative interviews will be conducted in 10% of the intervention group. ETHICS AND DISSEMINATION: The protocol is approved by the regional research ethics committee (number H-1-2011-135), the Danish Data Protection Agency (reg. nr. 2007-58-0015) and follows the latest version of the Declaration of Helsinki. The results will be published in peer-reviewed journals and may possibly impact on rehabilitation guidelines. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01523145.

A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis--the CopenHeartIE trial protocol.

INTRODUCTION: Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20-40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work up to a year postdischarge. No studies investigating the effects of rehabilitation have been published. We present the rationale and design of the CopenHeart(IE) trial, which investigates the effect of comprehensive cardiac rehabilitation versus usual care for patients treated for IE. METHODS AND ANALYSIS: We will conduct a randomised clinical trial to investigate the effects of comprehensive cardiac rehabilitation versus usual care on the physical and psychosocial functioning of patients treated for IE. The trial is a multicentre, parallel design trial with 1 : 1 individual randomisation to either the intervention or control group. The intervention consists of five psychoeducational consultations provided by specialised nurses and a 12-week exercise training programme. The primary outcome is mental health (MH) measured by the standardised Short Form 36 (SF-36). The secondary outcome is peak oxygen uptake measured by the bicycle ergospirometry test. Furthermore, a number of exploratory analyses will be performed. Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial. A qualitative and a survey-based complementary study will be undertaken, to investigate postdischarge experiences of the patients. A qualitative postintervention study will explore rehabilitation participation experiences. ETHICS AND DISSEMINATION: The study complies with the Declaration of Helsinki and was approved by the regional research ethics committee (no H-1-2011-129) and the Danish Data Protection Agency (no 2007-58-0015). Study findings will be disseminated widely through peer-reviewed publications and conference presentations. REGISTRATION: Clinicaltrials.gov identifier: NCT01512615.