Duration of Device-Based Fever Prevention after Cardiac Arrest.

BACKGROUND: Guidelines recommend active fever prevention for 72 hours after cardiac arrest. Data from randomized clinical trials of this intervention have been lacking. METHODS: We randomly assigned comatose patients who had been resuscitated after an out-of-hospital cardiac arrest of presumed cardiac cause to device-based temperature control targeting 36°C for 24 hours followed by targeting of 37°C for either 12 or 48 hours (for total intervention times of 36 and 72 hours, respectively) or until the patient regained consciousness. The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category of 3 or 4 (range, 1 to 5, with higher scores indicating more severe disability; a category of 3 or 4 indicates severe cerebral disability or coma) within 90 days after randomization. Secondary outcomes included death from any cause and the Montreal Cognitive Assessment score (range, 0 to 30, with higher scores indicating better cognitive ability) at 3 months. RESULTS: A total of 393 patients were randomly assigned to temperature control for 36 hours, and 396 patients were assigned to temperature control for 72 hours. At 90 days after randomization, a primary end-point event had occurred in 127 of 393 patients (32.3%) in the 36-hour group and in 133 of 396 patients (33.6%) in the 72-hour group (hazard ratio, 0.99; 95% confidence interval, 0.77 to 1.26; P = 0.70) and mortality was 29.5% in the 36-hour group and 30.3% in the 72-hour group. At 3 months, the median Montreal Cognitive Assessment score was 26 (interquartile range, 24 to 29) and 27 (interquartile range, 24 to 28), respectively. There was no significant between-group difference in the incidence of adverse events. CONCLUSIONS: Active device-based fever prevention for 36 or 72 hours after cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma. (Funded by the Novo Nordisk Foundation; BOX ClinicalTrials.gov number, NCT03141099.).

Blood-Pressure Targets in Comatose Survivors of Cardiac Arrest.

BACKGROUND: Evidence to support the choice of blood-pressure targets for the treatment of comatose survivors of out-of-hospital cardiac arrest who are receiving intensive care is limited. METHODS: In a double-blind, randomized trial with a 2-by-2 factorial design, we evaluated a mean arterial blood-pressure target of 63 mm Hg as compared with 77 mm Hg in comatose adults who had been resuscitated after an out-of-hospital cardiac arrest of presumed cardiac cause; patients were also assigned to one of two oxygen targets (reported separately). The primary outcome was a composite of death from any cause or hospital discharge with a Cerebral Performance Category (CPC) of 3 or 4 within 90 days (range, 0 to 5, with higher categories indicating more severe disability; a category of 3 or 4 indicates severe disability or coma). Secondary outcomes included neuron-specific enolase levels at 48 hours, death from any cause, scores on the Montreal Cognitive Assessment (range, 0 to 30, with higher scores indicating better cognitive ability) and the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability) at 3 months, and the CPC at 3 months. RESULTS: A total of 789 patients were included in the analysis (393 in the high-target group and 396 in the low-target group). A primary-outcome event occurred in 133 patients (34%) in the high-target group and in 127 patients (32%) in the low-target group (hazard ratio, 1.08; 95% confidence interval [CI], 0.84 to 1.37; P = 0.56). At 90 days, 122 patients (31%) in the high-target group and 114 patients (29%) in the low-target group had died (hazard ratio, 1.13; 95% CI, 0.88 to 1.46). The median CPC was 1 (interquartile range, 1 to 5) in both the high-target group and the low-target group; the corresponding median modified Rankin scale scores were 1 (interquartile range, 0 to 6) and 1 (interquartile range, 0 to 6), and the corresponding median Montreal Cognitive Assessment scores were 27 (interquartile range, 24 to 29) and 26 (interquartile range, 24 to 29). The median neuron-specific enolase level at 48 hours was also similar in the two groups. The percentages of patients with adverse events did not differ significantly between the groups. CONCLUSIONS: Targeting a mean arterial blood pressure of 77 mm Hg or 63 mm Hg in patients who had been resuscitated from cardiac arrest did not result in significantly different percentages of patients dying or having severe disability or coma. (Funded by the Novo Nordisk Foundation; BOX ClinicalTrials.gov number, NCT03141099.).

Oxygen Targets in Comatose Survivors of Cardiac Arrest.

BACKGROUND: The appropriate oxygenation target for mechanical ventilation in comatose survivors of out-of-hospital cardiac arrest is unknown. METHODS: In this randomized trial with a 2-by-2 factorial design, we randomly assigned comatose adults with out-of-hospital cardiac arrest in a 1:1 ratio to either a restrictive oxygen target of a partial pressure of arterial oxygen (Pao2) of 9 to 10 kPa (68 to 75 mm Hg) or a liberal oxygen target of a Pao2 of 13 to 14 kPa (98 to 105 mm Hg); patients were also assigned to one of two blood-pressure targets (reported separately). The primary outcome was a composite of death from any cause or hospital discharge with severe disability or coma (Cerebral Performance Category [CPC] of 3 or 4; categories range from 1 to 5, with higher values indicating more severe disability), whichever occurred first within 90 days after randomization. Secondary outcomes were neuron-specific enolase levels at 48 hours, death from any cause, the score on the Montreal Cognitive Assessment (ranging from 0 to 30, with higher scores indicating better cognitive ability), the score on the modified Rankin scale (ranging from 0 to 6, with higher scores indicating greater disability), and the CPC at 90 days. RESULTS: A total of 789 patients underwent randomization. A primary-outcome event occurred in 126 of 394 patients (32.0%) in the restrictive-target group and in 134 of 395 patients (33.9%) in the liberal-target group (hazard ratio, 0.95; 95% confidence interval, 0.75 to 1.21; P = 0.69). At 90 days, death had occurred in 113 patients (28.7%) in the restrictive-target group and in 123 (31.1%) in the liberal-target group. On the CPC, the median category was 1 in the two groups; on the modified Rankin scale, the median score was 2 in the restrictive-target group and 1 in the liberal-target group; and on the Montreal Cognitive Assessment, the median score was 27 in the two groups. At 48 hours, the median neuron-specific enolase level was 17 µg per liter in the restrictive-target group and 18 µg per liter in the liberal-target group. The incidence of adverse events was similar in the two groups. CONCLUSIONS: Targeting of a restrictive or liberal oxygenation strategy in comatose patients after resuscitation for cardiac arrest resulted in a similar incidence of death or severe disability or coma. (Funded by the Novo Nordisk Foundation; BOX ClinicalTrials.gov number, NCT03141099.).

Combined effects of targeted blood pressure, oxygenation, and duration of device-based fever prevention after out-of-hospital cardiac arrest on 1-year survival: post hoc analysis of a randomized controlled trial.

BACKGROUND: The "Blood Pressure and Oxygenation Targets in Post Resuscitation Care" (BOX) trial investigated whether a low versus high blood pressure target, a restrictive versus liberal oxygenation target, and a shorter versus longer duration of device-based fever prevention in comatose patients could improve outcomes. No differences in rates of discharge from hospital with severe disability or 90-day mortality were found. However, long-term effects and potential interaction of the interventions are unknown. Accordingly, the objective of this study is to investigate both individual and combined effects of the interventions on 1-year mortality rates. METHODS: The BOX trial was a randomized controlled two-center trial that assigned comatose resuscitated out-of-hospital cardiac arrest patients to the following three interventions at admission: A blood pressure target of either 63 mmHg or 77 mmHg; An arterial oxygenation target of 9-10 kPa or 13-14 kPa; Device-based fever prevention administered as an initial 24 h at 36 °C and then either 12 or 48 h at 37 °C; totaling 36 or 72 h of temperature control. Randomization occurred in parallel and simultaneously to all interventions. Patients were followed for the occurrence of death from all causes for 1 year. Analyzes were performed by Cox proportional models, and assessment of interactions was performed with the interventions stated as an interaction term. RESULTS: Analysis for all three interventions included 789 patients. For the intervention of low compared to high blood pressure targets, 1-year mortality rates were 35% (138 of 396) and 36% (143 of 393), respectively, hazard ratio (HR) 0.92 (0.73-1.16) p = 0.47. For the restrictive compared to liberal oxygenation targets, 1-year mortality rates were 34% (135 of 394) and 37% (146 of 395), respectively, HR 0.92 (0.73-1.16) p = 0.46. For device-based fever prevention for a total of 36 compared to 72 h, 1-year mortality rates were 35% (139 of 393) and 36% (142 of 396), respectively, HR 0.98 (0.78-1.24) p = 0.89. There was no sign of interaction between the interventions, and accordingly, no combination of randomizations indicated differentiated treatment effects. CONCLUSIONS: There was no difference in 1-year mortality rates for a low compared to high blood pressure target, a liberal compared to restrictive oxygenation target, or a longer compared to shorter duration of device-based fever prevention after cardiac arrest. No combination of the interventions affected these findings. Trial registration ClinicalTrials.gov NCT03141099, Registered 30 April 2017.

Challenges and benefits of using the HeartDiet food frequency questionnaire in cardiac rehabilitation practice.

BACKGROUND AND AIMS: A heart-healthy diet is an important component of secondary prevention in ischemic heart disease. The Danish Health Authority recommends using the validated 19-item food frequency questionnaire HeartDiet in cardiac rehabilitation practice to assess patients' need for dietary interventions, and HeartDiet has been included in national electronic patient-reported outcome instruments for cardiac rehabilitation. This study aims to evaluate challenges and benefits of its use. The objectives are to: 1) describe HeartDiet responses of patients with ischemic heart disease and discuss HeartDiet's suitability as a screening tool, 2) discuss whether an abridged version should replace HeartDiet. METHODS AND RESULTS: A cross-sectional study using data from a national feasibility test. HeartDiet was sent electronically to 223 patients with ischemic heart disease prior to cardiac rehabilitation. Data were summarised with descriptive statistics, and Spearman's rank correlations, explorative factor analysis, and Cohen's kappa coefficient were used to derive and evaluate abridged versions. The response rate was 68 % (n = 151). Evaluated with HeartDiet, no respondents had a heart-healthy diet. There was substantial agreement between HeartDiet and an abridged 9-item version (kappa = 0.6926 for Fat Score, 0.6625 for FishFruitVegetable Score), but the abridged version omits information on milk products, wholegrain, nuts, and sugary snacks. CONCLUSION: With the predefined cut-offs, HeartDiet's suitability as a screening tool to assess needs for dietary interventions was limited, since no respondents were categorised as having a heart-healthy diet. An abridged version can replace HeartDiet, but the tool's educational potential will be compromised, since important items will be omitted.

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.

Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management.

Patient-reported outcomes (PROs) provide important insights into patients' own perspectives about their health and medical condition, and there is evidence that their use can lead to improvements in the quality of care and to better-informed clinical decisions. Their application in cardiovascular populations has grown over the past decades. This statement describes what PROs are, and it provides an inventory of disease-specific and domain-specific PROs that have been developed for cardiovascular populations. International standards and quality indices have been published, which can guide the selection of PROs for clinical practice and in clinical trials and research; patients as well as experts in psychometrics should be involved in choosing which are most appropriate. Collaborations are needed to define criteria for using PROs to guide regulatory decisions, and the utility of PROs for comparing and monitoring the quality of care and for allocating resources should be evaluated. New sources for recording PROs include wearable digital health devices, medical registries, and electronic health record. Advice is given for the optimal use of PROs in shared clinical decision-making in cardiovascular medicine, and concerning future directions for their wider application.

Discharge Information About Adverse Drug Reactions Indicates Lower Self-Reported Adverse Drug Reactions and Fewer Concerns in Patients After Percutaneous Coronary Intervention.

AIM: There are discrepancies between the information patients desire about adverse drug reactions (ADRs) and the information they receive from healthcare providers; this is an impediment to shared decision-making. This study aimed to establish whether patients received information about ADRs resulting from prescribed pharmacotherapy, before hospital discharge, after percutaneous coronary intervention (PCI) and to determine whether receiving information about ADRs was associated with incidence of self-reported ADRs or concerns related to prescribed pharmacotherapy. METHODS: CONCARDPCI, a prospective multicentre cohort study including 3,417 consecutive patients after PCI, was conducted at seven high-volume referral PCI centres in two Nordic countries. Clinical data were collected from patients' medical records and national quality registries. Patient-reported outcome measures were registered 2 months (T1), 6 months (T2), and 12 months (T3) after discharge. Covariate-adjusted logistic regression yielded adjusted odds ratios (aORs) with 95% confidence intervals (CIs). RESULTS: At discharge, 38% of participants had been informed about potential ADRs. For these patients, the incidence of self-reported ADRs was significantly lower at T1 (aOR 0.61, 95% CI 0.50-0.74; p<0.001), T2 (aOR 0.60, 95% CI 0.49-0.74; p<0.001), and T3 (aOR 0.57, 95% CI 0.46-0.71; p<0.001). Those who were not informed reported higher levels of concern about prescribed pharmacotherapy at all measuring points (p<0.001 for all comparisons). Those living alone (aOR 0.73, 95% CI 0.57-0.92; p=0.008), who were female (aOR 0.57, 95% CI 0.44-0.72; p<0.001), and with three or more versus no comorbidities (aOR 0.61, 95% CI 0.44-0.84; p=0.002) were less likely to receive information. CONCLUSION: A substantial proportion of patients were not informed about potential ADRs from prescribed pharmacotherapy after PCI. Patients informed about ADRs had lower incidences of self-reported ADRs and fewer concerns about prescribed pharmacotherapy.

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.

With Fearful Eyes: Exploring Relatives' Experiences With Out-of-Hospital Cardiac Arrest: A Qualitative Study.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) imposes significant consequences for a family, but little is known about relatives' experiences. OBJECTIVE: Our aim was to explore relatives' experiences with the OHCA and the following months after. METHOD: A qualitative approach using phenomenological-hermeneutic methodology was applied. Data consisted of semistructured interviews with 12 relatives of OHCA survivors. We analyzed data based on Paul Ricoeur's theory of interpretation. RESULTS: Relatives experienced OHCA as an abrupt and stressful event filled with imposing concerns for the cardiac arrest survivor. Relatives were fellow sufferers confronted with the possibility of bereavement, watching from the sideline with fearful eyes. After the OHCA, relatives experienced a troubled time with anxiety and edginess, monitoring the survivor for signs of a new cardiac arrest and trying to adapt to a new normality. Relatives' previous identities and positions within their families were disrupted. CONCLUSION: Relatives were challenged with the OHCA and the trajectory after it, experiencing a high level of distress and anxiety. Relatives took on an immense responsibility, always watching the survivor for potential symptoms of a new cardiac arrest. The cardiac arrest and the survivor's possible cognitive impairments gave rise to assuming a new authority as a relative. We advocate for a new family approach to relatives, acknowledging relatives' stress and central role in supporting cardiac arrest survivors.

Association Between Risk Factors and Readmission for Patients With Atrial Fibrillation Treated With Catheter Ablation: Results From the Nationwide DenHeart Study.

BACKGROUND: Because of high readmission rates for patients treated with ablation for atrial fibrillation (AF), there is great value in nurses knowing which risk factors make the largest contribution to readmission. OBJECTIVE: The aims of this study were to (1) describe potential risk factors at discharge and (2) describe the associations of risk factors with readmission from 60 days to 1 year after discharge. METHODS: Data from a national cross-sectional survey exploring patient-reported outcomes were used in conjunction with data from national health registers. This study included patients who had an ablation for AF during a single calendar year. The Hospital Anxiety and Depression Scale and questions on risk factors were included. Sociodemographic and clinical data were collected through registers, and readmissions were examined at 1 year. RESULTS: In total, 929 of 1320 (response rate, 70%) eligible patients treated with ablation for AF completed the survey. One year after ablation, there were 333 (36%) acute readmissions for AF and 401 (43%) planned readmissions for AF. Readmissions were associated with ischemic heart disease, anxiety, and depression. CONCLUSION: High observed readmission rates were associated with risk factors that included anxiety and depression. Postablation care should address these risk factors.

Sex Differences in Patient-Reported Outcomes in the Immediate Recovery Period After Resuscitation: Findings From the Cross-sectional DenHeart Survey.

BACKGROUND: A paucity of resuscitation studies have examined sex differences in patient-reported outcomes upon hospital discharge. It remains unclear whether male and female patients differ in health outcomes in their immediate responses to trauma and treatment after resuscitation. OBJECTIVES: The aim of this study was to examine sex differences in patient-reported outcomes in the immediate recovery period after resuscitation. METHODS: In a national cross-sectional survey, patient-reported outcomes were measured by 5 instruments: symptoms of anxiety and depression (Hospital Anxiety and Depression Scale), illness perception (Brief Illness Perception Questionnaire [B-IPQ]), symptom burden (Edmonton Symptom Assessment Scale [ESAS]), quality of life (Heart Quality of Life Questionnaire), and perceived health status (12-Item Short Form Survey). RESULTS: Of 491 eligible survivors of cardiac arrest, 176 (80% male) participated. Compared with male, resuscitated female reported worse symptoms of anxiety (Hospital Anxiety and Depression Scale-Anxiety score ≥8) (43% vs 23%; P = .04), emotional responses (B-IPQ) (mean [SD], 4.9 [3.12] vs 3.7 [2.99]; P = .05), identity (B-IPQ) (mean [SD], 4.3 [3.10] vs 4.0 [2.85]; P = .04), fatigue (ESAS) (mean [SD], 5.26 [2.48] vs 3.92 [2.93]; P = .01), and depressive symptoms (ESAS) (mean [SD], 2.60 [2.68] vs 1.67 [2.19]; P = .05). CONCLUSIONS: Between sexes, female survivors of cardiac arrest reported worse psychological distress and illness perception and higher symptom burden in the immediate recovery period after resuscitation. Attention should focus on early symptom screening at hospital discharge to identify those in need of targeted psychological support and rehabilitation.

Phenotyping Self-Reported Health Profiles in Octogenarians and Nonagenarians After Percutaneous Coronary Intervention: A Latent Profile Analysis.

BACKGROUND: Little is known about self-reported health in octogenarians (≥80 years) and nonagenarians (≥90 years) following percutaneous coronary intervention (PCI), including characteristics of different health outcomes. This study aimed to phenotype latent health profiles of self-reported health in older adults 2 months post-PCI. METHODS: A prospective, multicentre, real-world study (CONCARDPCI) of 270 octogenarians and nonagenarians was performed with five validated and standardised measures of self-reported health at 2 months post-PCI. Latent profile analysis was used to identify health profiles, and multinomial logistic regression analyses were used to investigate the associations between patient characteristics and health profiles. RESULTS: Three latent health profiles were identified: The Poor health profile included 29%, the Moderate health profile included 39%, and the Good health profile included 32% of the participants. Older adults who were frail (OR 2.50, 95% CI 1.17-5.33), had a low exercise level (OR 0.49, 95% CI 0.39-0.95), and low alcohol intake (OR 0.61, 95% CI 0.39-0.95) were more likely to belong to the Poor health profile relative to the Good health profile. Furthermore, older age (OR 1.19, 95% CI 1.03-1.37) and lower exercise level (OR 0.64, 95% CI 0.43-0.97) were associated with belonging to the Moderate health profile relative to the Good health profile. CONCLUSION: Two months after PCI, most participants displayed having Moderate to Good health profiles. Those with a Poor health profile were more likely to be frail and less active. These findings highlight that follow-up care has to be patient-centred and tailored to improve the health status of older adults.

The association between cardiac drug therapy and anxiety among cardiac patients: results from the national DenHeart survey.

BACKGROUND: Neuropsychiatric side effects of cardiac drugs such as nervousness, mood swings and agitation may be misinterpreted as symptoms of anxiety. Anxiety in cardiac patients is highly prevalent and associated with poor outcomes, thus an accurate identification is essential. The objectives were to: (I) describe the possible neuropsychiatric side effects of common cardiac drug therapies, (II) describe the use of cardiac drug therapy in cardiac patients with self-reported symptoms of anxiety compared to those with no symptoms of anxiety, and (III) investigate the association between the use of cardiac drug therapy and self-reported symptoms of anxiety. METHODS: DenHeart is a large national cross-sectional survey combined with national register data. Symptoms of anxiety were measured by the Hospital Anxiety and Depression Scale (HADS-A) on patients with ischemic heart disease, arrhythmia, heart failure and heart valve disease. Side effects were obtained from 'product summaries', and data on redeemed prescriptions obtained from the Danish National Prescription Registry. Multivariate logistic regression analyses explored the association between cardiac drug therapies and symptoms of anxiety (HADS-A ≥ 8). RESULTS: Among 8998 respondents 2891 (32%) reported symptoms of anxiety (HADS-A ≥ 8). Neuropsychiatric side effects were reported from digoxin, antiarrhythmics, beta-blockers, ACE-inhibitors and angiotensin receptor antagonists. Statistically significant higher odds of reporting HADS ≥ 8 was found in users of diuretics, lipid-lowering agents, nitrates, antiarrhythmics and beta-blockers compared to patients with no prescription. CONCLUSION: Some cardiac drugs were associated with self-reported symptoms of anxiety among patients with cardiac disease. Of these drugs neuropsychiatric side effects were only reported for antiarrhythmics and beta-blockers. Increased awareness about the possible adverse effects from these drugs are important.

Patient-reported outcomes, sociodemographic and clinical factors are associated with 1-year mortality in patients with ischemic heart disease-findings from the DenHeart cohort study.

PURPOSE: In patients with ischemic heart disease, the objectives were (1) to explore associations between patient-reported outcomes, sociodemographic, and clinical factors at discharge and 1-year all-cause mortality and (2) to investigate the discriminant predictive performance of the applied patient-reported outcome instruments on 1-year all-cause mortality. METHODS: Data from the Danish national DenHeart cohort study were used. Eligible patients (n = 13,476) were invited to complete a questionnaire-package, of which 7167 (53%) responded. Questionnaires included the 12-item Short form health survey (SF-12), Hospital anxiety and depression scale (HADS), EQ-5D, HeartQoL, Edmonton symptom assessment scale (ESAS), and ancillary questions on, e.g., social support. Clinical and demographic characteristics were obtained from registers, as were data on mortality. Comparative analyses were used to investigate differences in patient-reported outcomes. Mortality associations were explored using multifactorially adjusted Cox regression analyses. Predictive performance was analyzed using receiver operating characteristics (ROC). RESULTS: Patient-reported outcomes at discharge differed among those alive versus those deceased at one year, e.g., depression (HADS-Depression ≥ 8) 19% vs. 44% (p < 0.001). Associations with 1-year mortality included feeling unsafe about returning home from the hospital; hazard ratio (HR) 2.07 (95% CI 1.2-3.61); high comorbidity level, HR 3.6 (95% CI 2.7-4.8); and being unmarried, HR 1.60 (95% CI 1.33-1.93). Best predictive performance was observed for SF-12 physical component summary (Area under the curve (AUC) 0.706). CONCLUSION: Patient-reported health, sociodemographic, and clinical factors are associated with 1-year mortality. We propose systematic screening with robust predictive tools to identify patients at risk and healthcare initiatives to explore and offer effective treatment to modify patient-reported health indicators.

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.

Cause of Death Among Cardiac Patients With and Without Anxiety.

BACKGROUND: Mental distress is reported internationally among patients with cardiac disease. A Danish survey found that 25% of patients with cardiac disease experienced symptoms indicating anxiety and that anxiety was associated with an increased risk of death. AIM: The aims of this study were to (1) compare cause of death patterns among deceased cardiac patients with anxiety to those without anxiety and (2) examine the association between anxiety symptoms and specific causes of death. METHODS: We used data from the DenHeart survey to evaluate symptoms of anxiety at discharge by using the Hospital Anxiety and Depression Scale. Data on mortality in the 3 years after discharge and cause of death according to International Classification of Diseases-10 classification came from national registers. Cause of death was compared between patients with and without anxiety using χ2 tests. The association between symptoms of anxiety and cause of death was investigated using logistic regression. RESULTS: Of 12 913 patients included, a total of 1030 (8%) died within 3 years. After 1 year, 4% of patients with anxiety symptoms had died versus 2% of patients without; after 3 years, the proportions were 9% versus 8%, respectively. Almost all died of natural causes irrespective of anxiety symptoms. No statistically significant differences were found regarding the cause of death between patients with and without anxiety. CONCLUSION: Despite higher mortality rates in patients with cardiac disease with anxiety symptoms, the pattern of cause of death was identical for patients with cardiac disease with and without anxiety symptoms. It seems that an acceleration of morbid processes leading to mortality is more likely than a difference in cause of death. However, further research is needed to better understand the behavioral and pathophysiological processes that cause the higher mortality seen among patients reporting symptoms of anxiety.

Prognostic value of a brief loneliness questionnaire for patients with coronary heart disease: Proposal for a prediction model.

BACKGROUND: In patients with coronary heart disease (CHD), loneliness is associated with increased risk of morbidity and mortality. No predictive tool is available to detect patients who are influenced by loneliness to a degree that impacts mortality. AIM: To: (i) propose a prediction model that detects patients influenced by loneliness to a degree that increases one-year all-cause mortality, (ii) evaluate model classification performance of the prediction model, and (iii) investigate potential questionnaire response errors. METHOD: A cohort of patients with CHD (n = 7169) responded to a national cross-sectional survey, including two questions on loneliness. Information on cohabitation and follow-up information on one-year all-cause mortality were obtained from national registers. Prediction model development was based on the prognostic values of item responses in the questionnaire on loneliness and of cohabitation, evaluated with Cox-proportional Hazards Ratio (HR). Item responses which significantly predicted one-year mortality were included in the high-risk loneliness (HiRL) prediction model. Sensitivity, specificity and likelihood ratio were calculated to evaluate model classification performance. Sources of response errors were evaluated using verbal probing technique in an additional cohort (n = 7). The TRIPOD checklist has been used to ensure transparent reporting. RESULTS: Two item responses significantly predicted one-year mortality HR = 2.24 (95%CI = 1.24-4.03) and HR = 2.65 (95%CI = 1.32-5.32) and were thus included in the model. Model classification performance showed a likelihood ratio of 1.89. Response error was evaluated as low. CONCLUSION: Based on the prognostic value in a loneliness questionnaire, a prediction model suitable to screen patients with CHD for high-risk loneliness was suggested. RELEVANCE TO CLINICAL PRACTICE: The HiRL prediction model is a short and easy-to-use screening tool that offers clinical staff to identify patients with CHD who are influenced by loneliness to a degree that impacts mortality. However, further evaluation of model performance and questionnaire validation is recommended before integrating the model into clinical practice.

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.

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.