Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC).

Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions' selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence. The new Medical Device Regulation is more stringent than its predecessor, yet its scope does not span all intended uses and several difficulties remain. The European Society of Cardiology Regulatory Affairs Committee set up a Task Force to explore existing assessment frameworks and clinical and cost-effectiveness evidence. This knowledge was used to propose criteria with which HCPs could evaluate mHealth solutions spanning diagnostic support, therapeutics, remote follow-up and education, specifically for cardiac rhythm management, heart failure and preventive cardiology. While curated national libraries of health apps may be helpful, their requirements and rigour in initial and follow-up assessments may vary significantly. The recently developed CEN-ISO/TS 82304-2 health app quality assessment framework has the potential to address this issue and to become a widely used and efficient tool to help drive decision-making internationally. The Task Force would like to stress the importance of co-development of solutions with relevant stakeholders, and maintenance of health information in apps to ensure these remain evidence-based and consistent with best practice. Several general and domain-specific criteria are advised to assist HCPs in their assessment of clinical evidence to provide informed advice to patients about mHealth utilization.

Prevalence of interarm blood pressure difference is notably higher in women; the Viborg population-based screening program (VISP).

BACKGROUND: Bilateral blood pressure (BP) measurement is important in cardiovascular prevention for identifying systolic interarm BP difference (IAD) and hypertension. We investigated sex-stratified IAD prevalence and its associations and coexistence with screen-detected peripheral atherosclerosis and hypertension. Furthermore, we determined the proportion misclassified as non-hypertensive when using the lower versus the higher reading arm. METHODS: This sub-study formed part of the Viborg Screening Program (VISP), a cross-sectorial population-based cardiovascular screening programme targeting 67-year-old Danes. VISP includes screening for peripheral atherosclerosis (lower extremity arterial disease and carotid plaque), abdominal aortic aneurysm, hypertension, diabetes mellitus, and cardiac disease. Self-reported comorbidities, risk factors, and medication use were also collected. Among 4,602 attendees, 4,517 (82.1%) had eligible bilateral and repeated BP measurements. IAD was defined as a systolic BP difference ≥ 10 mmHg. IAD-associated factors (screening results and risk factors) were estimated by logistic regression; proportional coexistence was displayed by Venn diagrams (screening results). RESULTS: We included 2,220 women (49.2%) and 2,297 men (50.8%). IAD was more predominant in women (26.8%) than men (21.0%) (p < 0.001). This disparity persisted after adjustment [odds ratio (OR) 1.53; 95% confidence interval (CI) 1.32-1.77]. No other association was recorded with the conditions screened for, barring potential hypertension: BP 140-159/90-99 mmHg (OR 1.68, 95% CI 1.44-1.97) and BP ≥ 160/100 mmHg (OR 1.82, 95% CI 1.49-2.23). Overall, IAD and BP ≥ 160/100 mmHg coexistence was 4% in women and 5% in men; for BP ≥ 140/90 mmHg, 13% and 14%, respectively. Among those recording a mean BP ≥ 140/90 mmHg in the higher reading arm, 14.5% of women and 15.3% of men would be misclassified as non-hypertensive compared with the lowest reading arm. CONCLUSION: Female sex was an independent factor of IAD prevalence but not associated with other arterial lesions. Approximately 15% needed reclassification according to BP ≥ 140/90 mmHg when the lower rather than the higher reading arm was used; verifying bilateral BP measurements improved detection of potential hypertension. In future, the predictive value of sex-stratified IAD should be assessed for cardiovascular events and death to verify its potential as a screening tool in population-based cardiovascular screening. TRIAL REGISTRATION FOR VISP: NCT03395509:10/12/2018.

Incidence and assessment of delirium following open cardiac surgery; A systematic review and meta-analysis.

AIM: This systematic review and meta-analysis sought i) to provide an overview of the incidence of delirium following open cardiac surgery and ii) to investigate how incidences of delirium are associated with different assessment tools. METHODS AND RESULTS: A systematic search of studies investigating delirium following open cardiac surgery were conducted in Medline (Ovid), EMBASE, PsycINFO, CiNAHL and the Cochrane Database. Only studies with patients diagnosed or screened with a validated tool were included. Studies published from 2005 to 2021 were included in the meta-analysis.Of 7,126 individual studies retrieved, 106 met the inclusion criteria for the meta-analysis, hereof 31% of high quality. The weighted pooled incidence of delirium following open cardiac surgery across all studies was 23% (95% CI 20-26%), however we found a considerable heterogeneity (I2 = 99%), which could not be explained by subgroups or further sensitivity analyses. The most commonly applied screening tool for delirium is CAM/CAM-ICU. The lowest estimates of delirium were found by applying the Delirium Observation Scale (incidence 14%, 95% CI 8-20%), and the highest estimates in studies using "other" screening tools (Organic Brain Symptom Scale, Delirium Symptom Interview) pooled incidence of 43%, (95% CI 19 - 66%), however, only two studies applied these. CONCLUSION: Delirium following open cardiac surgery remains a complication with a high incidence of overall 23%, when applying a validated tool for screening or diagnosis. Nevertheless, this systematic review and meta-analyses highlight the significant inconsistency in current evidence regarding assessment tools and regimens. REGISTRATION: Prospero CRD42020215519.

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.

The association between health-related quality of life, self-reported characteristics and 1- and 3-year mortality amongst cardiac patients with and without type 2 diabetes.

PURPOSE: The objectives amongst cardiac patients with and without type 2 diabetes were to (i) describe self-reported characteristics as health-related quality of life (HRQoL), health behaviour, body mass index (BMI) and physical shape and to (ii) investigate the association between self-reported characteristics and 1- and 3-year mortality. METHODS: Adult patients (≥ 18 years) discharged with a cardiac diagnosis were invited to participate in a national survey, DenHeart. Self-reported characteristics included HRQoL (EQ-5D-5L and HeartQol), health behaviour (alcohol and smoking), BMI and physical shape. Data were linked to national registries. The association between self-reported characteristics and 1- and 3-year mortality were investigated using the Cox Proportional Hazard Regression model, reported as hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: In total, 16,659 cardiac responders were included (n = 2,205 with type 2 diabetes, n = 14,454 without type 2 diabetes). Self-reported characteristics were worse amongst cardiac patients with type 2 diabetes compared to those without. After three years, the mortality rate was 14% amongst responders with diabetes and 7% amongst responders without type 2 diabetes (p ≤ 0.001). Better HRQoL was associated with a reduced risk of mortality amongst both groups. "Never been smoking" significantly reduced the risk of 1- and 3-year mortality amongst cardiac patients without diabetes, whereas good physical shape was associated with a reduced risk across both groups. CONCLUSION: HRQoL, health behaviour, BMI and physical shape are significantly worse amongst cardiac patients with type 2 diabetes. Better HRQoL was associated with a reduced risk of mortality amongst both groups, whereas other self-reported characteristics and the mortality risk varied.

Long-term effects of cardiac rehabilitation after heart valve surgery - results from the randomised CopenHeartVR trial.

Aims. The CopenHeartVR trial found positive effects of cardiac rehabilitation (CR) on physical capacity at 4 months. The long-term effects of CR following valve surgery remains unclear, especially regarding readmission and mortality. Using data from he CopenHeartVR Trial we investigated long-term effects on physical capacity, mental and physical health and effect on mortality and readmission rates as prespecified in the original protocol. Methods. A total of 147 participants were included after heart valve surgery and randomly allocated 1:1 to 12-weeks exercise-based CR including a psycho-educational programme (intervention group) or control. Physical capacity was assessed as peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing, mental and physical health by Short Form-36 questionnaire, Hospital Anxiety and Depression Scale, and HeartQol. Mortality and readmission were obtained from hospital records and registers. Groups were compared using mixed regression model analysis and log rank test. Results. No differences in VO2 peak at 12 months or in self-assessed mental and physical health at 24 months (68% vs 75%, p = .120) was found. However, our data demonstrated reduction in readmissions in the intervention group at intermediate time points; after 3, 6 (43% vs 59%, p = .03), and 12 (53% vs 67%, p = .04) months, respectively, but no significant effect at 24 months. Conclusions. Exercise-based CR after heart valve surgery reduces combined readmissions and mortality up to 12 months despite lack of improvement in exercise capacity, physical and mental health long-term. Exercise-based CR can ensure short-term benefits in terms of physical capacity, and lower readmission within a year, but more research is needed to sustain these effects over a longer time period. These considerations should be included in the management of patients after heart valve surgery.

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.

Health-Related Quality of Life and Angina in Fractional Flow Reserve- Versus Angiography-Guided Coronary Artery Bypass Grafting: FARGO Trial (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization).

BACKGROUND: In coronary artery bypass grafting (CABG), the use of fractional flow reserve (FFR) is insufficiently investigated. Stenosis assessment usually relies on visual estimates of lesion severity. This study evaluated health-related quality of life (HRQoL) and angina after FFR- versus angiography-guided CABG. METHODS: One hundred patients referred for CABG were randomized to FFR- or angiography-guided CABG. In the FFR group, lesions with FFR>0.80 were deferred, while the surgeon was blinded to the FFR values in the angiography group. Before and 6 months after CABG, HRQoL was assessed by the health state classifier EQ-5D of the EuroQoL 5-level instrument and angina status based on the Canadian Cardiovascular Society classification system were registered. RESULTS: Six-month angiography included FFR evaluations of deferred lesions. In total, completed EQ-5D of the EuroQoL 5-level instrument questionnaires were available in 86 patients (43 in the FFR versus 43 in the angiography-guided group). HRQoL was significantly improved and angina significantly decreased from baseline to 6 months after CABG with no difference between the randomization groups. Graft failure rates and clinical outcomes were similar in both groups. Patients with graft failure or FFR<0.80 of the previous deferred lesions had significantly lower visual analogue scale scores (78.7±14.2 versus 86.8±14.7, P=0.004) and more angina compared with patients without graft failure or FFR≥0.80 at 6-month follow-up. CONCLUSIONS: FFR- versus angiography-guided CABG demonstrated similar improvements in HRQoL and angina 6 months after CABG. Graft failure or low FFR in deferred lesions were associated with low HRQoL and angina. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02477371.

Exercise-based cardiac rehabilitation for adults after heart valve surgery.

BACKGROUND: The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery. OBJECTIVES: To assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. We considered CR programmes consisting of exercise training with or without another intervention (such as an intervention with a psycho-educational component). SEARCH METHODS: We searched the Cochrane Central Register of Clinical Trials (CENTRAL), in the Cochrane Library; MEDLINE (Ovid); Embase (Ovid); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO); PsycINFO (Ovid); Latin American Caribbean Health Sciences Literature (LILACS; Bireme); and Conference Proceedings Citation Index-Science (CPCI-S) on the Web of Science (Clarivate Analytics) on 10 January 2020. We searched for ongoing trials from ClinicalTrials.gov, Clinical-trials.com, and the World Health Organization International Clinical Trials Registry Platform on 15 May 2020. SELECTION CRITERIA: We included randomised controlled trials that compared exercise-based CR interventions with no exercise training. Trial participants comprised adults aged 18 years or older who had undergone heart valve surgery for heart valve disease (from any cause) and had received heart valve replacement or heart valve repair. Both percutaneous and surgical procedures were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. We assessed the risk of systematic errors ('bias') by evaluating risk domains using the 'Risk of bias' (RoB2) tool. We assessed clinical and statistical heterogeneity. We performed meta-analyses using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence for primary outcomes (all-cause mortality, all-cause hospitalisation, and health-related quality of life). MAIN RESULTS: We included six trials with a total of 364 participants who have had open or percutaneous heart valve surgery. For this updated review, we identified four additional trials (216 participants). One trial had an overall low risk of bias, and we classified the remaining five trials as having some concerns. Follow-up ranged across included trials from 3 to 24 months. Based on data at longest follow-up, a total of nine participants died: 4 CR versus 5 control (relative risk (RR) 0.83, 95% confidence interval (CI) 0.26 to 2.68; 2 trials, 131 participants; GRADE quality of evidence very low). No trials reported on cardiovascular mortality. One trial reported one cardiac-related hospitalisation in the CR group and none in the control group (RR 2.72, 95% CI 0.11 to 65.56; 1 trial, 122 participants; GRADE quality of evidence very low). We are uncertain about health-related quality of life at completion of the intervention in CR compared to control (Short Form (SF)-12/36 mental component: mean difference (MD) 1.28, 95% CI -1.60 to 4.16; 2 trials, 150 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD 2.99, 95% CI -5.24 to 11.21; 2 trials, 150 participants; GRADE quality of evidence very low), or at longest follow-up (SF-12/36 mental component: MD -1.45, 95% CI -4.70 to 1.80; 2 trials, 139 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD -0.87, 95% CI -3.57 to 1.83; 2 trials, 139 participants; GRADE quality of evidence very low).  AUTHORS' CONCLUSIONS: Due to lack of evidence and the very low quality of available evidence, this updated review is uncertain about the impact of exercise-CR in this population in terms of mortality, hospitalisation, and health-related quality of life. High-quality (low risk of bias) evidence on the impact of CR is needed to inform clinical guidelines and routine practice.

Illness Perception After Heart Valve Surgery: Differences Among Men and Women.

BACKGROUND: Illness perception is composed of thoughts, ideas, and beliefs about illness, and a negative illness perception is known to be associated with poor outcomes. Among men and women, clinical outcomes after heart valve surgery are known to differ, but knowledge about differences in illness perception is sparse. OBJECTIVES: The aim of this study is to describe the differences in illness perception among men and women after open heart valve surgery and to identify sociodemographic and clinical characteristics associated with worse illness perception in men and women. METHODS: In a national cross-sectional study combined with register-based clinical and sociodemographic information, data on illness perception were collected with the Brief Illness Perception Questionnaire.Worse illness perception was defined as the worst quartile of each item of the Brief Illness Perception Questionnaire. Multiple logistic regression analyses were conducted to explore characteristics associated with worse illness perception. RESULTS: Of 1084 eligible patients, 32% (n = 349) completed the questionnaire (67% men; mean age, 68 years). Compared with men, women reported significantly worse scores of illness perception in 6 of 8 items. Furthermore, being female, age, length of stay, and comorbidity were associated with worse illness perception (worse quartile of scores). Age, higher educational level, and comorbidity were found to be associated with worse illness perception for men and length of stay for women. CONCLUSION: After open heart valve surgery, illness perception differs among men and women, with women having worse illness perception. Among the total population, being female, age, a longer length of stay, and comorbidity were also associated with worse illness perception.

Supplementing prediction by EuroSCORE with social and patient-reported measures among patients undergoing cardiac surgery.

OBJECTIVES: The risk of poor outcomes is traditionally attributed to biological and physiological processes in cardiac surgery. However, evidence exists that other factors, such as emotional, behavioral, social, and functional, are predictive of poor outcomes. Objectives were to evaluate the predictive value of several emotional, social, functional, and behavioral factors on four outcomes: death within 90 days, prolonged stay in intensive care, prolonged hospital admission, and readmission within 90 days following cardiac surgery. METHODS: This prospective study included adults undergoing cardiac surgery 2013-2014, including information on register-based socioeconomic factors and self-reported health in a nested subsample. Logistic regression analyses to determine the association and incremental value of each candidate predictor variable were conducted. Multiple regression analyses were used to determine the incremental value of each candidate predictor variable, as well as discrimination and calibration based on the area under the curve (AUC) and Brier score. RESULTS: Of 3217 patients, 3% died, 9% had prolonged intensive care stay, 51% had prolonged hospital admission, and 39% were readmitted to hospital. Patients living alone (odds ratio, 1.19; 95% confidence interval, 1.02-1.38), with lower educational levels (1.27; 1.04-1.54) and low health-related quality of life (1.43; 1.02-2.01) had prolonged hospital admission. Analyses revealed living alone as predictive of prolonged intensive care unit (ICU) stay (Brier, 0.08; AUC, 0.68), death (0.03; 0.71), and prolonged hospital admission (0.24; 0.62). CONCLUSION: Living alone was found to supplement EuroSCORE in predicting death, prolonged hospital admission, and prolonged ICU stay following cardiac surgery. Low educational level and impaired health-related quality of life were, furthermore, predictive of prolonged hospital admission.

Association between frailty and self-reported health following heart valve surgery.

BACKGROUND: Knowledge about the association between frailty and self-reported health among patients undergoing heart valve surgery remains sparse. Thus, the objectives were to I) describe changes in self-reported health at different time points according to frailty status, and to II) investigate the association between frailty status at discharge and poor self-reported health four weeks after discharge among patients undergoing heart valve surgery. METHODS: In a prospective cohort study, consecutive patients undergoing heart valve surgery, including transapical/transaortic valve procedures were included. Frailty was measured using the Fried score, and self-reported health using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQoL-5 Dimensions 5-Levels Health Status Questionnaire (EQ-5D-5L).To investigate the association between frailty and self-reported health, multivariable logistic regression models were used. Analyses were adjusted for sex, age, surgical risk evaluation (EuroScore) and procedure and presented as odds ratios (OR) with 95% confidence intervals (CI). RESULTS: Frailty was assessed at discharge in 288 patients (median age 71, 69% men); 51 patients (18%) were frail. In the multivariable analyses, frailty at discharge remained significantly associated with poor self-reported health at four weeks, OR (95% CI): EQ-5D-5L Index 3.38 (1.51-7.52), VAS 2.41 (1.13-5.14), and KCCQ 2.84 (1.35-5.97). CONCLUSION: Frailty is present at discharge in 18% of patients undergoing heart valve surgery, and being frail is associated with poor self-reported health at four weeks of follow-up. This supports a clinical need to address the unique risk of frail patients among heart valve teams broadly, and not only to measure frailty as a marker of operative risk.

Employment status before and after open heart valve surgery: A cohort study.

OBJECTIVE: Detachment from the workforce following open heart valve surgery is a burden for the patient and society. The objectives were to examine patterns of employment status at different time points and to investigate factors associated with a lower likelihood of returning to the workforce within six months. METHODS: A cohort study of patients aged 18-63 undergoing valvular surgery at a Danish tertiary centre from 2013-2017. Return to the workforce was defined as being employed, unemployed (still capable of working) or receiving paid leave of absence. The association between demographic-, clinical characteristics (including a surgical risk evaluation, EuroScore), and return to the workforce were investigated with a multivariable logistic regression model. RESULTS: In total, 1,395 consecutive patients underwent surgery, 347 were between 18 and 63 years and eligible for inclusion. Of those, 282 were attached to the workforce before surgery and included in the study. At the time of surgery, 79% were on paid sick leave. After six months, 21% of the patients (being part of the workforce before surgery), were still on sick leave. In the regression model, prolonged sick leave prior to surgery (OR 0.43, 95% CI 0.23-0.79) and EuroScore ≥ 2.3 (OR 0.39, 95% CI 0.21-0.74) significantly reduced the likelihood of returning to the workforce. CONCLUSION: One-fifth of patients in the working-age were on sick leave six months after surgery. Prolonged sick leave prior to surgery and a EuroScore ≥2.3 were associated with a lower likelihood of returning to the workforce.

The association between self-reported health status and adverse events: a comparison among coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI).

PURPOSE: While several studies have investigated clinical outcomes following coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI), studies investigating self-reported health and the association with adverse outcomes are limited. Thus, the aim was to investigate differences in health-related quality of life (HRQoL), anxiety and depression at discharge and the association with a composite endpoint of the first event of acute cardiac readmission, revascularisation or 1-year mortality among patients undergoing CABG vs. PCI. METHODS: Data from the national cohort study, DenHeart, were used, including measures of HRQoL; EuroQoL-5D-5L (EQ-5D Index Score and VAS) and HeartQoL (Global, Physical and Emotional), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and register-based follow-up. A total of 7000 patients were included (CABG n = 652, PCI n = 6348) (median age 65, 75% men). Cox Proportional Hazard models were performed among a propensity-matched population of responders (n = 520). RESULTS: HRQoL was significantly better among patients undergoing PCI vs. CABG, but with no differences in time to readmission or revascularisation. HRQoL, anxiety and depression were significantly associated with the risk of the composite endpoint among the PCI group (Hazard Ratio, HR (95% confidence intervals, CI) [EQ-5D index score 3.07 (1.67-5.67), EQ-5D VAS 0.97 (0.96-0.99), HeartQol Global 0.61 (0.38-0.95), HeartQol Emotional 0.56 (0.39-0.80), HADS-D ≥ 8 3.12 (1.61-6.01), HADS-A ≥ 8 2.08 (1.14-3.80)]. CONCLUSION: Patients undergoing PCI reported better HRQoL at discharge compared with patients undergoing CABG, whereas readmission rates were similar. Self-reported health was associated with the risk of adverse events among patients undergoing PCI, but not among patients undergoing CABG. CLINICAL TRIAL REGISTRATION: NCT01926145.

Causes and characteristics associated with early and late readmission after open-heart valve surgery.

OBJECTIVES: The objectives of the study were to describe the causes of readmission from discharge to 30 days and from day 31 to 180 after discharge and to investigate the characteristics associated with overall and cause-specific readmissions after open-heart valve surgery. METHODS: A single-center, retrospective cohort of 980 patients undergoing open-heart valve surgery from 2013 to 2016. Time to the first readmission was analyzed using univariable and multivariable Cox proportional hazard models. Results are reported as hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: In total, 366 patients (37%) experienced unplanned cardiac readmission within 180 days after discharge. Within 30 days after discharge, the most frequent causes of readmission were pericardial/pleural effusions (n = 87), infections (n = 50), and atrial fibrillation/flutter (n = 45). Accordingly, infections (n = 32) were the most common cause from day 31 to 180. No powerful predictors of overall cardiac readmission were identified, but several characteristics were associated with cause-specific readmissions: age ≤65 years (HR: 1.85; CI: 1.18-2.88), male gender (HR: 1.85; CI: 1.11-3.09), high alcohol intake (HR: 1.99; CI: 1.22-3.24) and mitral valve procedures (HR: 1.86; CI: 1.11-3.10) were associated with readmissions due to effusions. Ischemic heart disease with a prior percutaneous coronary intervention (HR: 2.94; CI: 1.53-5.63), mitral valve procedures (HR: 2.10; CI: 1.23-3.59), and postoperative atrial fibrillation/flutter (HR: 1.71; CI: 1.03-2.85) were associated with atrial fibrillation/flutter readmissions. CONCLUSION: Predicting overall readmissions after open-heart valve surgery is difficult as causes of readmissions vary and different causes are associated with different characteristics. Future studies should target reducing cause-specific readmissions.

Patient-reported outcomes predict high readmission rates among patients with cardiac diagnoses. Findings from the DenHeart study.

BACKGROUND: High rates of readmission after myocardial infarction and cardiac surgery have been reported, indicating a heavy burden for both patients and society. Patient-reported outcomes are predictors of adverse outcomes such as morbidity and mortality and may also be useful in preventive risk assessment as predictors of readmission. AIM: To describe (i) the prevalence of cardiac readmissions one year after hospital discharge among cardiac patients, (ii) patient-reported outcomes at hospital discharge as predictors of readmission. METHODS: The following patient-reported outcomes were measured across cardiac diagnoses at hospital discharge from the five heart centres, cardiology and thoracic surgery units, as a part of the national, cross-sectional DenHeart Study: Short-Form 12 (SF-12), Hospital Anxiety and Depression Scale (HADS), EuroQoL (EQ-5D-5L), HeartQoL and the Edmonton Symptom Assessment Scale (ESAS). One year readmissions were obtained from national registers. RESULTS: A total of 34,564 cardiac patients were discharged of whom 16,712 patients completed the questionnaire. A total of 11,693 (36%) patients were readmitted for cardiac reasons at least once during the first year after index admission. The risk of readmission was predicted by anxiety (HR = 1.36 (CI:1.26-1.46)) and depression (HR = 1.42 (CI:1.31-1.55)). Higher scores reflected lower readmission risk on the physical (HR = 0.98 (CI:0.98-0.98)) health component of the SF-12. CONCLUSION: A total of 36% of cardiac patients admitted to a national heart center were readmitted during the first year. Readmission was predicted by patient-reported anxiety, depression, perceived health, quality of life and symptom distress, which may be used in risk assessment in clinical practice.

What to expect after open heart valve surgery? Changes in health-related quality of life.

PURPOSE: To (i) describe changes in health-related quality of life (HRQoL) pre-operatively, at discharge, and 4 weeks after discharge following open heart surgery, (ii) compare the performance of the EuroQol Questionnaire (EQ-5D 5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) against an anchor-based approach, and to (iii) investigate the association between HRQoL and 180-day readmission. METHODS: A prospective, consecutive cohort (single-center study) of 291 patients completed the EQ-5D 5L and KCCQ pre-operatively, at discharge and 4 weeks post-discharge. Changes in HRQoL over time were evaluated, and the performance of the instruments was investigated. The association between HRQoL and readmission were investigated with Cox Proportional Hazard models. RESULTS: Scores of the EQ-5D Index and VAS decreased significantly from the pre-operative assessment to discharge and improved from discharge to 4 weeks after. The KCCQ scores significantly improved from baseline to 4 weeks after. Minimal clinically important improvements from before surgery to 4 weeks after were seen among 24% (EQ-5D Index), 45% (EQ-5D VAS), and 57% (KCCQ). More than one-third experienced worse HRQoL 1 month after discharge. Area under the curve (AUC) (performance of the instruments) demonstrated the following: EQ-5D Index AUC 0.622 (95% CI 0.540-0.704), VAS AUC 0.674 (95% CI 0.598-0.750), and KCCQ AUC 0.722 (95% CI 0.65-0.792). None of the HRQoL measurements were associated with 180-day readmission. CONCLUSIONS: This study revealed that HRQoL measured with the EQ-5D is significantly worse at discharge compared to before surgery, but scores increases within the first month measured with the EQ-5D and the KCCQ. The EQ-5D and KCCQ have a moderate correlation with an anchor-based approach but were not associated with readmission.

Food and heart-the nutritional jungle: Patients' experiences of dietary habits and nutritional counselling after coronary artery bypass grafting.

AIMS AND OBJECTIVES: The aim of the study was to examine patients' experience of dietary habits and nutritional counselling in the early period during hospitalisation after coronary artery bypass surgery (CABG). BACKGROUND: Undergoing CABG, patients have two different nutritional needs, extra proteins and calories for the first period after surgery and a heart-healthy diet when the recovery period is over. These needs can be difficult to manage for the patients. DESIGN: Qualitative study. METHODS: Interviews were conducted and analysed within a phenomenological-hermeneutic frame inspired by the French philosopher Paul Ricoeur. Patients undergoing CABG were interviewed 4-5 days after surgery at Odense University Hospital from March to May, 2017. The study adhered to the COREQ guidelines. RESULTS: In total, 15 patients were interviewed (mean age 65 years, 87% men). After analysing the interviews following themes emerged, "Different needs-the nutritional jungle", "Food and heart-the lacking attention," and "The force of habits-being under the influence from spouses on dietary habits". CONCLUSION: The interviewed patients had no or only a little knowledge about how to eat after heart surgery. In general, they experienced a lack of attention to nutritional counselling by the nursing staff during hospitalisation. Furthermore, the health behaviour of men seems to be different from women's, and therefore, interventions aiming at optimising men's health might be prioritised. Finally, spouses have a great influence on eating habits, why they should be involved in nutritional counselling. RELEVANCE TO CLINICAL PRACTICE: This study provides important and relevant knowledge about patients' lacking knowledge about nutrition. When planning nutritional measures, whether it is promoting healing after heart surgery or preventing progression of arteriosclerosis, the study contributes with suggestions as to which factors should be considered in this process-men's health behaviour and spouses' influence on dietary habits in the household.

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.