Kirstine Lærum Sibilitz

High readmission rate after heart valve surgery: A nationwide cohort study

BACKGROUND After heart valve surgery, knowledge on long-term self-reported health status and readmission is lacking. Thus, the optimal strategy for out-patient management after surgery remains unclear. METHODS Using a nationwide survey with linkage to Danish registers with one year follow-up, we included all adults 6-12 months after heart valve surgery irrespective of valve procedure, during Jan-June 2011 (n = 867). Participants completed a questionnaire regarding health-status (n = 742), and answers were compared with age- and sex-matched healthy controls. Readmission rates and mortality were investigated. RESULTS After valve surgery, the self-reported health was lower (Short Form-36 (SF-36) Physical Component Scale (PCS): 44.5 vs. 50.6 and Mental Component Scale (MCS): 51.9 vs. 55.0, p < 0.0001) and more were physically sedentary compared with healthy controls (11.1% vs. 15.2%). Clinical signs of anxiety and depression were present in 13.6% and 13.8%, respectively (Hospital Anxiety and Depression Scale score ≥ 8). Twelve months following discharge, 483 persons (56%) were readmitted. Readmission was associated with lower self-reported health (SF-36 PCS: 46.5 vs. 43.9, and MCS 52.2 vs. 50.7). Higher age (hazard ratio (95% CI): 1.3 (1.0-1.6)), male sex (1.2 (1.0-1.5)), mitral valve surgery (1.3 (1.0-1.6)), and infective endocarditis after surgery (1.8 (1.1-3.0), p: 0.01) predicted readmission, whereas higher age (2.3 (1.0-5.4)), higher comorbidity score (3.2 (1.8-6.0)), and infective endocarditis after surgery (3.2 (1.2-8.9)) predicted mortality. CONCLUSIONS 6-12 months after heart valve surgery the readmission rate is high and the self-reported health status is low. Readmission is associated with low self-reported health. Therefore, targeted follow-up strategies post-surgery are needed.

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

BackgroundHeart 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.MethodsA 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.DiscussionThe 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 registrationClinicalTrials.gov (http://NCT01558765).

Availability of, referral to and participation in exercise-based cardiac rehabilitation after heart valve surgery: Results from the national CopenHeart survey

Background As with ischaemic heart disease, cardiac rehabilitation (CR) is recommended for patients undergoing heart valve surgery; recommendations are based on limited evidence. The organization of CR programmes and factors associated with uptake among patients undergoing heart valve surgery have not been studied. This study investigated CR programmes for these patients and factors associated with referral and participation. Design and methods We distributed two nationwide surveys: one to 37 hospitals and 98 municipalities and one to 742 consecutive patients undergoing heart valve surgery. Data were linked to nationwide registries. We analysed the provision and content of programmes using descriptive statistics, and factors associated with referral and participation using logistic regression analysis. Results Coverage of CR programmes for these patients was high, with national programme variation. The overall uptake rate was 52%. Simultaneous CABG was associated with a higher probability of referral to CR (OR 2.02 (95%CI 1.12–3.65)); being unmarried (0.44 (0.27–0.72)) and having TAVI with a lower probability (0.26; 0.13–0.52). The referral pattern varied across administrative regions, with patients in the capital region less likely to be referred (0.22 (0.08–0.57)). Patients with TAVI were less likely to participate (0.29 (0.12–0.70)). Conclusions Despite high national programme coverage, only half the patients post heart valve surgery received CR. Both factors identified at provider- and patient-level influenced uptake and included significant regional variation in referral pattern. Further research into the effect and organization of CR post heart valve surgery is needed.

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 VO2 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.

Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial

Objective The evidence for cardiac rehabilitation after valve surgery remains sparse. Current recommendations are therefore based on patients with ischaemic heart disease. The aim of this randomised clinical trial was to assess the effects of cardiac rehabilitation versus usual care after heart valve surgery. Methods The trial was an investigator-initiated, randomised superiority trial (The CopenHeartVR trial, VR; valve replacement or repair). We randomised 147 patients after heart valve surgery 1:1 to 12 weeks of cardiac rehabilitation consisting of physical exercise and monthly psycho-educational consultations (intervention) versus usual care without structured physical exercise or psycho-educational consultations (control). Primary outcome was physical capacity measured by VO2 peak and secondary outcome was self-reported mental health measured by Short Form-36. Results 76% were men, mean age 62 years, with aortic (62%), mitral (36%) or tricuspid/pulmonary valve surgery (2%). Cardiac rehabilitation compared with control had a beneficial effect on VO2 peak at 4 months (24.8 mL/kg/min vs 22.5 mL/kg/min, p=0.045) but did not affect Short Form-36 Mental Component Scale at 6 months (53.7 vs 55.2 points, p=0.40) or the exploratory physical and mental outcomes. Cardiac rehabilitation increased the occurrence of self-reported non-serious adverse events (11/72 vs 3/75, p=0.02). Conclusions Cardiac rehabilitation after heart valve surgery significantly improves VO2 peak at 4 months but has no effect on mental health and other measures of exercise capacity and self-reported outcomes. Further research is needed to justify cardiac rehabilitation in this patient group. Trial registration number NCT01558765, Results.

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.

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 CopenHeartIE 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.

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.

Physical activity increases survival after heart valve surgery

Objectives Increased physical activity predicts survival and reduces risk of readmission in patients with coronary heart disease. However, few data show how physical activity is associated with survival and readmission after heart valve surgery. Objective were to assess the association between physical activity levels 6–12 months after heart valve surgery and (1) survival, (2) hospital readmission 18–24 months after surgery and (3) participation in exercise-based cardiac rehabilitation. Methods Prospective cohort study with registry data from The CopenHeart survey, The Danish National Patient Register and The Danish Civil Registration System of 742 eligible patients. Physical activity was quantified with the International Physical Activity Questionnaire and analysed using Kaplan–Meier analysis and Cox regression and logistic regression methods. Results Patients with a moderate to high physical activity level had a reduced risk of mortality (3 deaths in 289 patients, 1%) compared with those with a low physical activity level (13 deaths in 235 patients, 5.5%) with a fully adjusted HR of 0.19 (95% CI 0.05 to 0.70). In contrast, physical activity level was not associated with the risk of hospital readmission. Patients who participated in exercise-based cardiac rehabilitation (n=297) were more likely than the non-participants (n=200) to have a moderate or high physical activity level than a low physical activity level (fully adjusted OR: 1.52, 95% CI 1.03 to 2.24). Conclusions Moderate to high levels of physical activity after heart valve surgery are positively associated with higher survival rates and participation in cardiac rehabilitation.

Creatinine, eGFR and association with myocardial infarction, ischemic heart disease and early death in the general population

OBJECTIVE We tested the hypothesis that moderately elevated plasma creatinine levels and decreased levels of estimated glomerular filtration rate (eGFR) are associated with increased risk of myocardial infarction, ischemic heart disease, and early death in the general population. METHODS We studied 10,489 individuals with a plasma creatinine measurement and calculated eGFR from the Danish general population, of which 1498 developed myocardial infarction, 3001 ischemic heart disease, and 7573 died during 32 years follow-up. RESULTS Cumulative incidences of myocardial infarction and ischemic heart disease as a function of age increased with increasing levels of creatinine, and survival decreased (log-rank trends: <0.001). The median survival age was 78.7 (95%CI: 78.0-79.2) years for persons with creatinine levels <90th percentile, 78.1 (76.3-79.5) years for 90th-94th percentiles, and 74.8 (72.8-76.7) years for ≥95th percentile. Hazard ratios for myocardial infarction and plasma creatinine levels of 90th-94th percentiles and ≥95th percentile versus <50th percentile were 2.06 (95%CI: 1.67-2.56) and 1.90 (1.56-2.31) adjusted for gender and age, and 1.35 (1.09-1.68) and 1.11 (0.90-1.36) adjusted multifactorially, respectively. Corresponding estimates for creatinine and ischemic heart disease were 1.57 (1.33-1.85) and 1.64 (1.42-1.89) adjusted for gender and age, and 1.16 (0.98-1.37) and 1.11 (0.95-1.29) adjusted multifactorially. Finally, corresponding values for early death were 1.18 (1.06-1.32) and 1.43 (1.30-1.57), and 0.97 (0.87-1.09) and 1.13 (1.02-1.24), respectively. Low eGFR did not associate consistently with increased risk of these endpoints. CONCLUSION In the general population, moderately elevated plasma creatinine was associated with increased risk of myocardial infarction, ischemic heart disease, and early death, while low eGFR was not.