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.

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.

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 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).

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.