Anne Vinggaard Christensen

Anxiety Predicts Mortality in ICD Patients: Results from the Cross-Sectional National CopenheartICD Survey with Register Follow-Up

Although highly effective in preventing arrhythmic death, patients receiving an implantable cardioverter defibrillator (ICD) may still experience psychological difficulties such as anxiety, depression, and reduced quality of life. The objectives of this study were to describe patient‐reported outcomes among ICD patients: (1) compared to a matched healthy population, (2) compared by ICD indication, (3) factors predicting patient‐reported outcomes, and (4) if patient‐reported outcomes predicted mortality.

Educational inequality in cardiovascular disease depends on diagnosis: A nationwide register based study from Denmark.

Background Social inequality is present in the morbidity as well as the mortality of cardiovascular diseases. This paper aims to quantify and compare the level of educational inequality across different cardiovascular diagnoses. Design Register based study. Methods Comparison of the extent of inequality across different cardiovascular diagnoses requires a measure of inequality which is comparable across subgroups with different educational distributions. The slope index of inequality and the relative index of inequality were applied for measuring inequalities in incidence of six cardiovascular diagnoses: ischaemic heart disease, acute myocardial infarction, valvular heart disease, congestive heart failure, atrial fibrillation and stroke in the period 2005–2009. All individuals in the general Danish population aged 35–84 years were followed in national registers regarding hospitalisation, death and education from 1985 to 2009 (annual average of 2.9 million people) to define incident cases. Results Marked educational inequality was found in the incidence of ischaemic heart disease, acute myocardial infarction, heart failure and stroke (relative index of inequality: 0.37 (95% confidence interval 0.34; 0.40) to 0.60 (0.57; 0.63), absolute index of inequality: −241 (−254.4; −227.4) to −37 (−42.7; −31.1)) while inequality in atrial fibrillation and, in particular, in valvular heart disease was small and insignificant (relative index of inequality: 0.57 (0.49; 0.65) to 0.97 (0.88; 1.08), absolute index of inequality: −29 (−35.1; −21.9) to −1 (−4.8; −3.8)). Conclusion The degree of educational inequality in cardiovascular diseases depends on the diagnosis, with the highest inequality in ischaemic heart disease, acute myocardial infarction, heart failure and stroke. Small differences were found between men and women.

Patient-reported outcomes at hospital discharge from Heart Centres, a national cross-sectional survey with a register-based follow-up: the DenHeart study protocol

Introduction Patient reported health status, which includes symptom burden, functional status and quality of life, is an important measure of health. Differences in health status between diagnostic groups within cardiology have only been sparsely investigated. These outcomes may predict morbidity, mortality, labour market affiliation and healthcare utilisation in various diagnostic groups. A national survey aiming to include all cardiac diagnostic groups from a total Heart Centre population has been designed as the DenHeart survey. Methods and analysis DenHeart is designed as a cross-sectional survey with a register-based follow-up. All diagnostic groups at the five national Heart Centres are included during 1 year (15 April 2013 to 15 April 2014) and asked to fill out a questionnaire at hospital discharge. The total eligible population, both responders and non-responders, will be followed in national registers. The following instruments are used: SF-12, Hospital Anxiety and Depression Scale, EQ-5D, Brief Illness Perception Questionnaire (B-IPQ), HeartQoL and Edmonton Symptom Assessment Scale. The following variables are collected from national registers: action diagnosis, procedures, comorbidity, length of hospital stay, type of hospitalisation, visits to general practitioners and other agents in primary healthcare, dispensed prescription medication, vital status and cause of death. Labour market affiliation, sick leave, early retirement pension, educational degree and income will be collected from registers. Frequency distributions and multiple logistic regression analyses will be used to describe and assess differences in patient reported outcomes at hospital discharge between diagnostic groups and in-hospital predicting factors. Cox proportional hazards regression models with age as the time scale will be used to investigate associations between patient reported outcomes at baseline and morbidity/mortality, labour market affiliation and healthcare utilisation after 1 year. Ethics and dissemination The study complies with the Declaration of Helsinki. The study has been approved by the Danish Data Protection Agency: 2007-58-0015/30-0937 and registered at ClinicalTrials.gov (NCT01926145). Study findings will be disseminated widely through peer reviewed publications and conference presentations.

Early physical training and psycho-educational intervention for patients undergoing coronary artery bypass grafting. The SheppHeart randomized 2 × 2 factorial clinical pilot trial.

Background: Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms such as immobility, pain and insufficient sleep. Results from trials investigating testing in-hospital physical exercise or psychological intervention have been promising. However, no randomized clinical trials have tested a comprehensive rehabilitation programme consisting of both physical exercise and psycho-education in the early rehabilitation phase. Aims: The aims of the present SheppHeart pilot randomized clinical trial were to evaluate the feasibility of patient recruitment, patient acceptance of the intervention, safety and tolerability of the intervention. Methods and design: Sixty patients admitted for coronary artery bypass graft were randomized 1:1:1:1 to: 1) physical exercise plus usual care, or 2) psycho-educational intervention plus usual care, or 3) physical exercise and psycho-educational plus usual care, or 4) usual care alone during a four week period after surgery. Results: The acceptability of trial participation was 67% during the three month recruitment period. In the physical exercise groups, patients complied with 59% of the total expected training sessions during hospitalization. Nine patients (30%) complied with >75% and nine patients (30%) complied with 50% of the planned exercise sessions. Eleven patients (42%) participated in ⩾75% of the four consultations and six patients (23%) participated in 50% of the psycho-educational programme. Conclusion: Comprehensive phase one rehabilitation combining physical exercise and psycho-education in coronary artery bypass graft patients shows reasonably high inclusion, feasibility and safety.

Effect of cardiac rehabilitation in patients with ICD: Are gender differences present?: results from the COPE-ICD trial

The COPE‐ICD (Copenhagen Outpatient ProgrammE‐implantable cardioverter defibrillator) trial studied comprehensive cardiac rehabilitation for patients with ICDs. The purpose of this paper was to explore: (1) gender differences in self‐rated health and quality of life (QoL) at hospital discharge after ICD implantation, (2) gender differences in effect of cardiac rehabilitation, and (3) predictors of effect of cardiac rehabilitation.

Implantable cardioverter defibrillator specific rehabilitation improves health cost outcomes: Findings from the COPE-ICD randomized controlled trial

OBJECTIVE The Copenhagen Outpatient ProgrammE - implantable cardioverter defibrillator (COPE-ICD) trial included patients with implantable cardioverter defibrillators in a randomized controlled trial of rehabilitation. After 6-12 months significant differences were found in favour of the rehabilitation group for exercise capacity, general and mental health. The aim of this paper is to explore the long-term health effects and cost implications associated with the rehabilitation programme; more specifically, (i) to compare implantable cardioverter defibrillator therapy history and mortality between rehabilitation and usual care groups; (ii) to examine the difference between rehabilitation and usual care groups in terms of time to first admission; and (iii) to determine attributable direct costs. METHODS Patients with first-time implantable cardioverter defibrillator implantation (n = 196) were randomized (1:1) to comprehensive cardiac rehabilitation or usual care. Outcomes were measured by implantable cardioverter defibrillator therapy history from patient records and national register follow-up on mortality, hospital admissions and costs. RESULTS No significant differences were found after 3 years for implantable cardioverter defibrillator therapy or mortality between rehabilitation and usual care. Time to first admission did not differ. The cost of rehabilitation was 335 USD/276 Euro per patient enrolled in rehabilitation. The total attributable cost of rehabilitation after 3 years was -6,789 USD/-5,593 Euro in favour of rehabilitation. CONCLUSION No long-term health outcome benefits were found for the rehabilitation programme. However, the rehabilitation programme resulted in a reduction in total attributable direct costs.

Sex differences in health status and rehabilitation outcomes in patients with atrial fibrillation treated with ablation: Results from the CopenHeartRFA trial.

Background: Increased physical capacity after comprehensive rehabilitation in patients with atrial fibrillation (AF) undergoing ablation has been found in the CopenHeartRFA trial. The purpose of this study was to investigate: (a) sex differences in health status, psychological distress and quality of life, (b) sex differences in rehabilitation outcomes and (c) predictors of effect of rehabilitation. Methods: We conducted an exploratory analysis of data from the randomized CopenHeartRFA trial, where patients treated with ablation were randomized with 1:1 to comprehensive rehabilitation consisting of a physical exercise program and psycho-educational consultations versus usual care. Sex disparities in health status were tested using Chi-square and t-tests. Results: Included were: 151 men (median age 59.25 years) and 59 women (median age 62.5 years). At hospital discharge, women reported lower physical health status compared with men. Among women, significant differences were found in the 6-min walk test [rehabilitation: 496.8 meters (SD 98.5) versus 559.3meters (SD 55.5) and usual care: 521.9 meters (SD 97.8) versus 530.9 meters (SD 102.2), p = 0.01] and exercise time [rehabilitation: 387.6 s (SD 126.0) versus 463.2 s (SD 121.8) and usual care: 353.4 s (SD 145.2) versus 355.8 s (SD 154.8), p < 0.004] and among men in the sit-to-stand test. Significant differences were found in mental health outcomes among men and in quality of life scores among women. Patients with a European Heart Rhythm Association (EHRA) score I-II had a positive effect of rehabilitation. Conclusion: The results suggest that sex differences exist in self-reported health after rehabilitation in patients ablated for AF. Patients with an I–II EHRA score seem more likely to gain from the rehabilitation programme compared with those with a III–IV score.

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.

The Screen-ICD trial. Screening for anxiety and cognitive therapy intervention for patients with implanted cardioverter defibrillator (ICD): a randomised controlled trial protocol

Introduction Previous research shows that patients with an implanted cardioverter defibrillator (ICD) have a fourfold increased mortality risk when suffering from anxiety compared with ICD patients without anxiety. This research supports the screening of ICD patients for anxiety with the purpose of starting relevant intervention. Methods and analysis Screen-ICD consists of 3 parts: (1) screening of all hospitalised and outpatient patients at two university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores ≥8 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive–behavioural therapy (CBT) performed by a cardiac nurse with CBT training, plus usual care or usual care alone. The primary outcome is HADS-A measured at 16 weeks. Secondary outcomes include Becks Anxiety Inventory, HeartQoL, Hamilton Anxiety Scale, heart rate variability, ICD shock, time to first shock and antitachycardia pacing. A total of 88 participants will be included. The primary analyses are based on the intention-to-treat principle and we use a mixed model with repeated measurements for continuous outcomes. For binary outcomes (HADS-A score <8), we use a generalised mixed model with repeated measurements. Ethics and dissemination The trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (RH-2015-282) and the regional ethics committee (H-16018868). Positive, neutral and negative results of the trial will be published. Trial registration number NCT02713360.

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.