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.

Delirium is frequently underdiagnosed among older hospitalised patients despite available information in hospital medical records.

BACKGROUND: In-hospital delirium is associated with adverse outcomes and is underdiagnosed, limiting research and clinical follow-up. OBJECTIVE: To compare the incidence of in-hospital delirium determined by chart-based review of electronic medical records (D-CBR) with delirium discharge diagnoses (D-DD). Furthermore, to identify differences in symptoms, treatments and delirium triggers between D-CBR and D-DD. METHOD: The community-based cohort included 2,115 participants in the Hordaland Health Study born between 1925 and 1927. Between 2018 and 2022, we retrospectively reviewed hospital electronic medical records from baseline (1997-99) until death prior to 2023. D-DD and D-CBR were validated using The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for delirium. RESULTS: Of the 2,115 participants, 638 had in-hospital delirium. The incidence rate (IR) of D-CBR was 29.8 [95% confidence interval 28, 32] per 1,000 person-years, whereas the IR by D-DD was 3.4 [2.8, 4.2]. The IR ratio was 9.14 (P < 0.001). Patients who received pharmacological treatment for delirium (n = 121, odds ratio (OR) 3.4, [2.1, 5.4], P < 0.001), who were affected by acute memory impairment (n = 149, OR 2.8, [1.8, 4.5], P < 0.001), or change in perception (n = 137, OR 2.9, [1.8, 4.6] P < 0.001) had higher odds for D-DD. In contrast, post-operative cases (OR 0.2, [0.1, 0.4], P < 0.001) had lower odds for D-DD. CONCLUSION: Underdiagnosis of in-hospital delirium was a major issue in our study, especially in less severe delirium cases. Our findings emphasise the need for integrating systematic delirium diagnostics and documentation into hospital admission and discharge routines.

Renegotiating identity. A Nordic study of adolescent's experiences of living with a parent having heart disease.

AIM: To explore adolescents' experiences of having a parent with heart disease. DESIGN: This qualitative study was performed with semi-structured individual interviews. METHODS: Interviews were conducted with 33 adolescents between 13 and 19 years old, who either had a mother or father with one of these diagnoses: ischemic heart disease, arrhythmia, heart failure, cardiac arrest or heart valve disease. The parent had been ill for at least 6 months and up to 5 years. The study was carried out in Denmark, Norway and Sweden between 2019 and 2022. The analysis was inspired by Reflexive Methodology. RESULTS: Three central themes emerged: Response to parental heart disease; Growing up ahead of time; and Strategies in a changed life situation. For the adolescents, heart disease was experienced as an acute and lethal disease that put their parents' lives in danger. New routines and roles not only changed everyday life within the family but they also enhanced maturity and appreciation of life. To maintain a balance in life, the adolescents pursued normality and sought a safe space to have a normal youthful life. CONCLUSION: In a period known to be significant for development, life with parental heart disease appeared as a biographical disruption because adolescents renegotiated their identity to manage their new life situation. IMPACT: It is important to help younger family members adapt to parental heart disease by informing them about possible reactions and supporting them in how to adapt to their new life by seeking breaks and normality. PATIENT OR PUBLIC CONTRIBUTION: No patient or public involvement.

Use of health services and perceived need for information and follow-up after percutaneous coronary intervention.

OBJECTIVE: Few patients achieve full control of their coronary artery disease (CAD) risk factors. Follow-up, such as cardiac rehabilitation, is important to increase adherence to lifestyle changes and treatment, to improve the patient's risk profile, and to treat established complications of CAD clinical events. However, the type of follow-up patients receive varies. Therefore, the aim of this research note was to describe and compare patients' self-reported use of health services, the type of follow-up patients reported to prefer, and the type of information patients reported to be important, in two countries with different follow-up practices after PCI. RESULTS: We included 3417 patients in Norway and Denmark, countries with different follow-up strategies after PCI. The results showed large differences between the countries regarding health services used. In Denmark the most frequently used health services were consultations at outpatient clinics followed by visits to the general practitioner and visits to the fitness centre, whereas in Norway visits to the general practitioner were most common, followed by rehospitalisation and no follow-up used. However, patients found the same type of follow-up and information important in both countries. Patients' perceived need for follow-up and information decreased over time, suggesting a need for early follow-up when the patients are motivated. TRIAL REGISTRATION: NCT03810612 (18/01/2019).

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.

Effectiveness, safety, and patient reported outcomes of a planned investment procedure in higher-risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest-CTO study.

BACKGROUND: The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated. STUDY DESIGN: Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported. CONCLUSION: This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.

Perceptions of generic medicines and medication adherence after percutaneous coronary intervention: a prospective multicentre cohort study.

OBJECTIVE: To determine patient perceptions of generic medicines 2 and 6 months after percutaneous coronary intervention (PCI), and to determine whether these perceptions moderate medication adherence. DESIGN: Prospective multicentre cohort study with repeated measures of perceptions of generic medicines and medication adherence. SETTING: The CONCARDPCI study conducted at seven large referral PCI centres in Norway and Denmark between June 2017 and May 2020. PARTICIPANTS: A total of 3417 adults (78% men), using both generic and brand name medicines, with a mean age of 66 years (SD 11) who underwent PCI were followed up 2 and 6 months after discharge from hospital. MAIN OUTCOME MEASURES: Perceptions of generic medicines were the main outcome. The secondary outcome was medication adherence. RESULTS: Perceptions of generic medicines were significantly more negative at 2 than at 6 months (1.10, 95% CI 0.41 to 1.79, p=0.002). Female sex (-4.21, 95% CI -6.75 to -1.71, p=0.001), older age (-0.12, 95% CI -0.23 to -0.02, p=0.020), lower education level (overall p<0.001), ethnicity (overall p=0.002), Norwegian nationality (10.27, 95% CI 8.19 to 12.40, p<0.001) and reduced self-reported health status (0.19, 95% CI 0.09 to 0.41, p=0.003) were significantly associated with negative perceptions of generic medicines. There was no evidence to suggest that perceptions of generic medicines moderate the association between sociodemographic and clinical variables and medication adherence (p≥0.077 for all covariates). Moreover, self-reported medication adherence was high, with 99% scoring at or above the Medication Adherence Report Scale midpoint at both time points. There were no substantial correlations between negative perceptions of generic medicines and medication non-adherence at 2 months (r=0.041, 95% CI 0.002 to 0.081, p=0.037) or 6 months (r=0.038, 95% CI -0.005 to 0.081, p=0.057). CONCLUSIONS: Mistrust and uncertainty about the safety and efficacy of generic medicines remains in a sizeable proportion of patients after PCI. This applies especially to those of lower socioeconomic status, older age, female sex, immigrants and those with poorer mental health. However, this study demonstrated a shift towards more positive perceptions of generic medicines in the longer term.

The impact of educational concerns and satisfaction on baccalaureate nursing students' distress and quality of life during the Covid-19 pandemic; a cross-sectional study.

BACKGROUND: High levels of psychological distress and poor overall quality of life (QOL) have been identified among nursing students during the COVID-19 pandemic. The pandemic necessitated improvised reconstructions of educational curriculums and restrictions in clinical placement and training at campuses, possibly reducing educational quality. OBJECTIVES: We explored whether baccalaureate nursing students' concerns and satisfaction with the educational curriculum, focusing on the conduct of clinical training, were associated with perceived psychological distress and overall QOL. METHODS: Baccalaureate nursing students (N=6088) from five Norwegian universities were invited to an internet-based, cross-sectional survey during the second wave of the pandemic. The survey included COVID-19 specific questions on health, education and clinical training, the Fear of COVID-19 scale (FCV-19S), The Hopkins Symptom Checklist (SCL-5) and overall QOL. Data from national surveys on satisfaction with the educational curriculum, before and during the pandemic were used for comparison. RESULTS: In total, 2605 (43%) students responded, of whom 1591 (61%) had been engaged in clinical training during the pandemic. Overall, 53% were either satisfied or fully satisfied with their educational curriculum, with the level of satisfaction being significantly lower than pre-pandemic reference values. Also, 79% were concerned or highly concerned about the educational quality. In multiple regression analyses for all students, lower levels of satisfaction and higher levels of quality concerns were associated with worse SCL-5 scores. Furthermore, satisfaction with the educational curriculum was positively associated with overall QOL. For students engaged in clinical training, only concerns about infecting others were additionally associated with psychological distress. None of the items related to clinical training were associated with overall QOL. CONCLUSION: Nursing students' educational satisfaction and quality concerns may significantly impact perceived psychological distress and overall QOL during a pandemic. However, with necessary adaptations implemented, concerns regarding the conduct of clinical training account for little of these associations.

Predictors of long-term symptom burden and quality of life in patients hospitalised with chest pain: a prospective observational study.

OBJECTIVE: To describe the magnitude and predictors of symptom burden (SB) and quality of life (QoL) 3 months after hospital admission for acute chest pain. DESIGN: Prospective observational study. SETTING: Single centre, outpatient follow-up. PARTICIPANTS: 1506 patients. OUTCOMES: Scores reported for general health (RAND-12), angina-related health (Seattle Angina Questionnaire 7 (SAQ-7)) and dyspnoea (Rose Dyspnea Scale) 3 months after hospital admission for chest pain. METHODS: A total of 1506 patients received questionnaires assessing general health (RAND-12), angina-related health (SAQ-7) and dyspnoea (Rose Dyspnea Scale) 3 months after discharge. Univariable and multivariable regression models identified predictors of SB and QoL scores. A mediator analysis identified factors mediating the effect of an unstable angina pectoris (UAP) diagnosis. RESULTS: 774 (52%) responded. Discharge diagnoses were non-ST elevation myocardial infarction (NSTEMI) (14.2%), UAP (17.1%), non-coronary cardiac disease (6.6%), non-cardiac disease (6.3%) and non-cardiac chest pain (NCCP) (55.6%). NSTEMI had the most favourable, and UAP patients the least favourable SAQ-7 scores (median SAQ7-summary; 88 vs 75, p<0.001). NCCP patients reported persisting chest pain in 50% and dyspnoea in 33% of cases. After adjusting for confounders, revascularisation predicted better QoL scores, while UAP, current smoking and hypertension predicted worse outcome. NSTEMI and UAP patients who were revascularised reported higher scores (p<0.05) in SAQ-7-QL, SAQ7-PL, SAQ7-summary (NSTEMI) and all SAQ-7 domains (UAP). Revascularisation altered the unstandardised beta value (>±10%) of an UAP diagnosis for all SAQ-7 and RAND-12 outcomes. CONCLUSIONS: Patients with NSTEMI reported the most favourable outcome 3 months after hospitalisation for chest pain. Patients with other diseases, in particular UAP patients, reported lower scores. Revascularised NSTEMI and UAP patients reported higher QoL scores compared with patients receiving conservative treatment. Revascularisation mediated all outcomes in UAP patients. TRIAL REGISTRATION NUMBER: NCT02620202.

Correlated physical and mental health composite scores for the RAND-36 and RAND-12 health surveys: can we keep them simple?

BACKGROUND: The RAND-36 and RAND-12 (equivalent to versions 1 of the SF-36 Health Survey and SF-12 Health Survey, respectively) are widely used measures of health-related quality of life. However, there are diverging views regarding how to create the physical health and mental health composite scores of these questionnaires. We present a simple approach using an unweighted linear combination of subscale scores for constructing composite scores for physical and mental health that assumes these scores should be free to correlate. The aim of this study was to investigate the criterion validity and convergent validity of these scores. METHODS: We investigated oblique and unweighted RAND-36/12 composite scores from a random sample of the general Norwegian population (N = 2107). Criterion validity was tested by examining the correlation between unweighted composite scores and weighted scores derived from oblique principal component analysis. Convergent validity was examined by analysing the associations between the different composite scores, age, gender, body mass index, physical activity, rheumatic disease, and depression. RESULTS: The correlations between the composite scores derived by the two methods were substantial (r = 0.97 to 0.99) for both the RAND-36 and RAND-12. The effect sizes of the associations between the oblique versus the unweighted composite scores and other variables had comparable magnitudes. CONCLUSION: The unweighted RAND-36 and RAND-12 composite scores demonstrated satisfactory criterion validity and convergent validity. This suggests that if the physical and mental composite scores are free to be correlated, the calculation of these composite scores can be kept simple.

Comprehensive cardiac rehabilitation for patients following infective endocarditis: results of the randomized CopenHeartIE trial.

AIMS: Infective endocarditis is a complex and highly mortal disease requiring lengthy treatment. Physical and mental deconditioning is common. Nonetheless, rehabilitation is virtually unexplored in this population. The aim of this trial was therefore to investigate the effects of cardiac rehabilitation in patients following endocarditis. METHODS AND RESULTS: In a randomized trial, adults with left-sided or cardiac device endocarditis were randomized 1:1 to 12 weeks of physical exercise training and five psycho-educational consultations (cardiac rehabilitation) vs. usual care without rehabilitation (control). Primary outcome was mental health measured by SF-36 Mental Component Summary (MCS) at 6 months. Secondary outcome was physical capacity measured by peak oxygen uptake (VO2) at 4 months. Exploratory outcomes were investigated. Low inclusion rate resulted in trial termination before reaching the target sample size. A total of 117 participants (mean age: 60 years, 81% male) were randomized to cardiac rehabilitation (n = 58) or to control (n = 59). Mental health and physical capacity at baseline were generally poor (MCS: 38.9-42.2 points, VO2 peak: 16.1-16.6 mL/kg/min). Cardiac rehabilitation compared with control showed no effect on mental health (MCS: 44.6 points vs. 48.8 points, P = 0.41) or physical capacity (VO2 peak: 19.9 mL/kg/min vs. 18.0 mL/kg/min, P = 0.09). Effects favouring the intervention were identified in exploratory outcomes including general fatigue (P = 0.005), and physical capacity as maximal power (W) (P = 0.005). Adherence to the intervention was 28%. CONCLUSIONS: Results indicate no effect of cardiac rehabilitation in patients following endocarditis; however, lack of statistical power and poor adherence render findings inconclusive. Valuable insight into patients' capabilities and safety was gained, and further investigations into rehabilitation needs and modes of delivery in this high-need population should be a future priority. REGISTRATION: The trial is registered at ClinicalTrials.gov, NCT01512615.

Baseline frailty status and outcomes important for shared decision-making in older adults receiving transcatheter aortic valve implantation, a prospective observational study.

AIMS: The objective of this study was to examine baseline frailty status (including cognitive deficits) and important clinical outcomes, to inform shared decision-making in older adults receiving transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We conducted a prospective, observational study of 82 TAVI patients, recruited 2013 to 2015, with 2-year follow-up. Mean age was 83 years (standard deviation (SD) 4.7). Eighteen percent of the patients were frail, as assessed with an 8-item frailty scale. Fifteen patients (18%) had a Mini-Mental Status Examination (MMSE) score below 24 points at baseline, indicating cognitive impairment or dementia and five patients had an MMSE below 20 points. Mean New York Heart Association (NYHA) class at baseline and 6 months was 2.5 (SD 0.6) and 1.4 (SD 0.6), (p < 0.001). There was no change in mean Nottingham Extended Activities of Daily Living (NEADL) scale between baseline and 6 months, 54.2 (SD 11.5) and 54.5 (SD 10.3) points, respectively, mean difference 0.3 (p = 0.7). At 2 years, six patients (7%) had died, four (5%, n = 79) lived in a nursing home, four (5%) suffered from disabling stroke, and six (7%) contracted infective endocarditis. CONCLUSIONS: TAVI patients had improvement in symptoms and maintenance of activity of daily living at 6 months. They had low mortality and most patients lived in their own home 2 years after TAVI. Complications like death, stroke, and endocarditis occurred. Some patients had cognitive impairment before the procedure which might influence decision-making. Our findings may be used to develop pre-TAVI decision aids.

Changes in quality of life 5 years after sleeve gastrectomy: a prospective cohort study.

OBJECTIVES: Sleeve gastrectomy (SG) is the most frequently performed bariatric surgery procedure worldwide, but reports on long-term quality of life (QOL) outcomes are scarce. We investigated 5-year trajectories in QOL and their associations with weight loss after SG. DESIGN: A prospective cohort study. SETTING: The study was conducted in a single Norwegian bariatric surgery centre. PARTICIPANTS: Out of 150 operated patients, 127 were included. Mean age was 41 years, 68% were women and the follow-up rate at 1 year was 85% and 64% at 1 and 5 years, respectively. OUTCOME MEASURES: Data were collected preoperatively, and 1 and 5 years after surgery assessing three different levels of QOL. The main exposure was weight loss after SG, assessed as per cent excess body mass index (kg/m2) loss (%EBMIL). The Obesity-Related Problem (OP) scale was used to measure obesity-specific health-related QOL (HRQOL). Physical (PCS) and mental (MCS) composite summary scores of the Short Form 36 Health Survey were used to capture generic HRQOL and Cantril Ladder was used to assess overall QOL. RESULTS: All HRQOL/overall QOL measures significantly improved at 1 year, followed by modest decline from 1 to 5 years after surgery. Greater %EBMIL 5 years after surgery was significantly associated with improvements in OP and PCS scores, but not with MCS and Cantril Ladder scores. Although significant (p<0.001) and clinically relevant improvements in HRQOL/overall QOL outcomes were observed at 5 years, scores were still below the general population norms. CONCLUSION: Most patients undergoing SG experience substantial weight loss accompanied by statistically significant and clinically relevant long-term improvements in HRQOL/overall QOL. However, an important minority of patients still report low HRQOL/overall QOL 5 years after SG. Further research should aim to identify other factors that contribute to impaired QOL after bariatric surgery, even in the presence of successful weight control.

A novel geriatric assessment frailty score predicts 2-year mortality after transcatheter aortic valve implantation.

AIMS: Established surgical scores have limitations in delineating risk among candidates for transcatheter aortic valve implantation (TAVI). Assessment of frailty might help to estimate the mortality risk and identify patients likely to benefit from treatment. The aim of the study was to develop a frailty score to guide the decision for TAVI. METHODS AND RESULTS: We conducted a prospective observational study in patients ≥70 years referred for TAVI during 2011-15. A Heart Team had declined the patients for open heart surgery due to high risk but accepted them for TAVI. Prior to the procedure, a geriatric assessment (GA) was performed. Based on this, an 8-element frailty score with a 0-9 (least frail-most frail) scale was developed. A total of 142 patients, 54% women, mean age 83 (standard deviation 4) years, with severe and symptomatic aortic stenosis were assessed. All-cause 2 year mortality was 11%. The novel GA frailty score predicted 2-year mortality in Cox analyses, also when adjusted for age, gender, and logistic EuroSCORE [hazard ratio (HR) 1.75, 95% confidence interval (CI): 1.28-2.42, P < 0.001]. A receiver operating characteristic (ROC) curve analysis indicated that a GA frailty score cut-off at ≥4 predicted 2-year mortality with a specificity of 80% (95% CI: 73-86%) and a sensitivity of 60% (95% CI: 36-80%). The area under the curve was 0.81 (95% CI 0.71-0.90). CONCLUSION: A novel 8-element GA frailty score identified gradations in survival in patients declined for open heart surgery. Patients with higher GA frailty scores had significantly higher 2-year mortality after TAVI.

Indwelling urinary catheters, aortic valve treatment and delirium: a prospective cohort study.

OBJECTIVES: To determine whether an association exists between delirium and length of time indwelling urine catheters (IUC) are used in octogenarian patients treated with surgical aortic valve treatment (SAVR) or transcatheter aortic valve implantation (TAVI). DESIGN: Prospective cohort study. SETTING: Tertiary university hospital covering the western region of Norway. PARTICIPANTS: Octogenarian patients undergoing elective SAVR or TAVI and willing to participate in the study were eligible. Patients unable to speak Norwegian were excluded. Between 2011 and 2013, 143 consecutive patients were included, and data from 136 of them are presented. PRIMARY OUTCOME: Delirium. RESULTS: Logistic regression analysis shows that lower cognitive function was positively associated with delirium (OR 0.86, CI 0.74 to 0.99, p=0.047). Besides, the interaction term in the model shows that IUC use and delirium differed between SAVR and TAVI patients (p=0.04). The difference corresponded to a weaker association between hours of IUC use and delirium for SAVR (OR 1.01, CI: 0.99 to 1.03, p=0.54) compared with that for TAVI (OR 1.04, CI: 1.01 to 1.08, p=0.004). CONCLUSIONS: The association between IUC use and delirium is stronger for octogenarian patients treated with TAVI than for patients who received SAVR. Our results revealed a previously unknown association between the number of hours an IUC is used and postoperative delirium in octogenarian patients treated with TAVI.

Dietary intake of saturated fat is not associated with risk of coronary events or mortality in patients with established coronary artery disease.

BACKGROUND: Data from recent meta-analyses question an association between dietary intake of saturated fatty acids (SFAs) and risk of cardiovascular disease (CVD). Moreover, the prognostic effect of dietary SFA in patients with established CVD treated with modern conventional medication has not been extensively studied. OBJECTIVE: We investigated the associations between self-reported dietary SFA intake and risk of subsequent coronary events and mortality in patients with coronary artery disease (CAD). METHODS: This study included patients who participated in the Western Norway B-Vitamin Intervention Trial and completed a 169-item semiquantitative food-frequency questionnaire after coronary angiography. Quartiles of estimated daily intakes of SFA were related to risk of a primary composite endpoint of coronary events (unstable angina pectoris, nonfatal acute myocardial infarction, and coronary death) and separate secondary endpoints (total acute myocardial infarction, fatal coronary events, and all-cause death) with use of Cox-regression analyses. RESULTS: This study included 2412 patients (81% men, mean age: 61.7 y). After a median follow-up of 4.8 y, a total of 292 (12%) patients experienced at least one major coronary event during follow-up. High intake of SFAs was associated with a number of risk factors at baseline. However, there were no significant associations between SFA intake and risk of coronary events [age- and sex-adjusted HR (95% CI) was 0.85 (0.61, 1.18) for the upper vs. lower SFA quartile] or any secondary endpoint. Estimates were not appreciably changed after multivariate adjustments. CONCLUSIONS: There was no association between dietary intake of SFAs and incident coronary events or mortality in patients with established CAD.

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.