Trine Bernholdt Rasmussen

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).

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.

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.

Mental health is a risk factor for poor outcomes in cardiac patients: Findings from the national DenHeart survey

OBJECTIVE To explore (i) the prevalence of cardiac risk factors (obesity, smoking, excessive alcohol consumption and medication non-adherence) among cardiac patients with depression and anxiety, (ii) associations between depression and anxiety scores and cardiac risk factors and (iii) the association of depression and anxiety and cardiac risk factors with mortality, and their population attributable risk. METHODS A national cross-sectional study using patient-reported outcomes at discharge and national register data. For one year (April 15th 2013 to April 15th 2014) all patients discharged or transferred from the five Danish Heart Centres were included in the study. A total of 14,239 patients answered the HADS questionnaire, response rate 51%. RESULTS Mean age was 64.8 years and 69% were male. Patients with depression or anxiety (HADS-D or HADS-A score ≥ 8) had 30% and 45%, respectively, higher odds of being current smokers; 19% and 37% higher odds of being obese and 31% and 24% higher odds of excessive alcohol consumption. Depressive patients had 34% higher odds of being non-adherent to their medication. At one-year follow-up, patients with depression (HADS-D score ≥ 11) had the highest attributable risk associated with mortality followed by: smoking, ischemic heart disease, anxiety, diabetes, hypertension chronic obstructive pulmonary disease and excessive alcohol consumption. CONCLUSION Depression and anxiety in patients with cardiac disease is associated with cardiac risk behaviour such as smoking, obesity, excessive alcohol consumption and medication non-adherence. Depression and anxiety have an attributable risk associated with mortality that is comparable to other well-known risk factors such as smoking.

Both mental and physical health predicts one year mortality and readmissions in patients with implantable cardioverter defibrillators: findings from the national DenHeart study

Background: Although highly effective in preventing arrhythmic death, there is a high prevalence of anxiety, depression and reduced quality of life among patients who have received an implantable cardioverter defibrillator (ICD). Whether mortality, ICD shock and readmission are predicted by patient-reported outcomes is unknown. Aim: The aim of this study was to describe patient-reported outcomes among patients with ICDs compared by: ICD indication and generator type (ICD or cardiac resynchronisation therapy ICD), and to determine whether patient-reported outcomes at discharge predict mortality, ICD therapy and readmission. Methods: A national cross-sectional survey at hospital discharge (n=998) with register follow-up. Patient-reported outcomes included the Hospital Anxiety and Depression Scale, Short Form-12, HeartQoL, EQ-5D and Edmonton Symptom Assessment Scale. Register data: ICD therapy, readmissions and mortality within one year following discharge. Results: Patients with primary prevention ICDs had significantly worse patient-reported outcomes at discharge than patients with secondary prevention ICDs. Likewise, patients with cardiac resynchronisation therapy ICDs had significantly worse patient-reported outcomes at discharge than patients without cardiac resynchronisation therapy. One-year mortality was predicted by patient-reported outcomes, with the highest hazard ratio (HR) being anxiety (HR 2.02; 1.06–3.86), but was not predicted by indication or cardiac resynchronisation therapy. ICD therapy and ventricular tachycardia/ventricular fibrillation were not predicted by patient-reported outcomes, indication or cardiac resynchronisation therapy. Overall, patient-reported outcomes predicted readmissions, e.g. symptoms of anxiety and depression predicted all readmissions within 3 months (HR 1.50; 1.13–1.98) and 1.47 (1.07–2.03), respectively). Conclusion: Patients with primary indication ICDs and cardiac resynchronisation therapy ICDs report worse patient-reported outcomes than patients with secondary indication and no cardiac resynchronisation therapy. Patient-reported outcomes such as mental health, quality of life and symptom burden predict one-year mortality and acute and planned hospital readmissions.

Validity, reliability and responsiveness of the Body Image Quality of Life Inventory in patients treated for infective endocarditis

RATIONALE AND OBJECTIVES Suffering through infective endocarditis (IE) can drastically alter a persons physical appearance, and body image-related concerns have been reported by patients. The extent and severity of the phenomenon has not previously been explored, as no quantitative measure has been validated in this patient population. The purpose of this study was thus to assess the validity, reliability and responsiveness of the Danish Body Image Quality of Life Inventory (BIQLI-DA) on patients treated for IE. METHODS We evaluated the psychometric properties of the BIQLI-DA on data obtained in the CopenHeart IE trial, which is a randomised clinical trial evaluating the effects of comprehensive cardiac rehabilitation for patients treated for IE. We administered the BIQLI-DA as part of data collection at baseline and 6 months. We examined the psychometric properties through correlations to other measures, including body mass index, Medical Outcome Short Form 36 and Hospital Anxiety and Depression Scale. In addition, we examined internal consistency on item and scale level and performed anova group-by-time interaction to test for responsiveness. RESULTS AND STUDY LIMITATION Participants were seventy patients with a mean age of 58 years and of which 83% were men. Results indicated convergent construct validity by confirming hypothesised associations to potentially related constructs. The BIQLI-DA was found to be highly internally consistent with a Cronbachs alpha of 0.96. Instrument responsiveness was indicated by a significant group-by-time interaction. Support for the validity of the BIQLI-DA might have been strengthened by a larger sample with more women. A more optimal design for testing responsiveness would possibly have allowed for clearer conclusions. CONCLUSIONS The BIQLI-DA may be applicable in healthcare research as it seems to be valid, reliable and responsive; however, evidence should be strengthened through further exploration of instrument performance, particularly regarding responsiveness.

Instrument translation and initial psychometric evaluation of the Danish Body Image Quality of Life Inventory.

RATIONALE AND OBJECTIVES Negative body perception has been reported in a number of patient populations. No instrument in Danish for measuring body image-related concerns has been available. Without such an instrument, understanding of the phenomenon in Danish-speaking populations is limited. The purpose of the study was thus to translate and validate a Danish version of the Body Image Quality of Life Inventory (BIQLI), in order to obtain a valid instrument applicable for healthcare research. METHODS The study consisted of two phases: (i) instrument adaptation, including forward and back translation, expert committee comparisons and cognitive interviewing, and (ii) empirical testing of the Danish version (BIQLI-DA) with subsequent psychometric evaluation. Hypothesised correlations to other measures, including body mass index (BMI), Medical Outcome Short Form-8 (SF-8), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 and Symptom Check List-90-Revised (SCL-90-R® ) were tested. In addition, exploratory factor structure analysis (EFA) and internal consistency on item and scale level were performed. RESULTS AND STUDY LIMITATIONS The adapted instrument was found to be semantically sound, yet concerns about face validity did arise through cognitive interviews. Danish college students (n = 189, 65 men, Mage = 21.1 years) participated in the piloting of the BIQLI-DA. Convergent construct validity was demonstrated through associations to related constructs. Exploratory factor analysis revealed a potential subscale structure. Finally, results showed a high internal consistency (Cronbachs alpha = 0.92). Support for the validity of the BIQLI-DA might have been strengthened by repeating cognitive interviews after layout alterations, by piloting the instrument on a larger sample. CONCLUSIONS This study demonstrated tentative support for the validity of the Danish Body Image Quality of Life (BIQLI-DA) and found the measure to be reliable in terms of internal consistency. Further exploration of response processes and construct validity is needed.

High readmission rates and mental distress after infective endocarditis: results from the national population-based copenheart ie survey

Background: Heart failure is a common chronic condition that affects patients’ life situation and puts high demands on self-care and patient participation. Patients often need advanced care due to ...