Sex and Gender Differences in Psychosocial Risk Profiles Among Patients with Coronary Heart Disease - the THORESCI-Gender Study.

BACKGROUND: Psychosocial factors tend to cluster and exhibit differences associated with sex assigned at birth. Gender disparities, though, remain uncharted so far. The current study aimed to first explore the clustering of eight established psychosocial risk factors among patients with coronary heart disease (CHD), followed by examining how sex and gender differences characterize these psychosocial risk profiles, while adjusting for the effect of age. METHOD: In total, 532 patients with CHD (Mage = 68.2 ± 8.9; 84% male) completed the comprehensive psychosocial screener and questionnaires to gauge gender identity, traits, and sociocultural norm scores. A three-step latent profile analysis (LPA) was performed to identify latent profiles and their correlates. RESULTS: LPA revealed six psychosocial risk profiles: (1) somewhat distressed overall (32%); (2) low distress (27%); (3) anger, hostility, and Type D (15%); (4) emotional distress and trauma (11%); (5) anxiety (9%); and (6) high overall distress (7%). Masculine traits and older age increased the odds to belong to the low distress profile (#2), while feminine traits and a feminine gender norm score increased the chance to belong to profiles with moderate to high distress. The effects of gender identity and feminine traits were sex dependent. CONCLUSION: The current study's findings explain heterogeneity among patients with CHD by considering the joint occurrence of psychosocial risk factors, and the role of sex, age, and gender within those profiles. Being more sensitive to the roles that sex, gender, and an integrated set of risk factors play may ultimately improve treatment and adherence.

Instrumental, Affective, and Patient-Centered Communication Between Cardiologists and Patients with Low Socioeconomic Status: An Observational Study.

One of the essential elements in managing health is having adequate communication with health care providers. Unfortunately, patients with a low socioeconomic status (SES) often experience less adequate communication with their doctor. In the current study, we explore and compare the communication of both doctors and patients from lower and higher sociodemographic backgrounds on three factors: instrumental, affective, and patient-centered communication. In total, 45 cardiology consultations were observed, transcribed, and coded (16 low-SES, 16 middle-SES, 13 high-SES). Our analyses showed that, compared to higher-SES patients, low-SES patients voiced less of their concerns, answered questions of the doctor more often with one word, and expressed less utterances overall. Naturally, we found that doctors expressed more utterances overall toward low-SES patients. For doctors, no differences regarding instrumental, affective, or patient-centered communication were found. These findings suggest that low-SES patients are more passive communicators and communication differences based on SES exist predominantly for patients' communication. The revealed communication differences may lead to a less adequate interaction and potentially worse patient outcomes, further increasing the socioeconomic health gap. Hence, doctors should become even more aware of socioeconomic patient communication differences so that they can appropriately encourage low-SES patients to become more active communicators.

The importance, consequences and treatment of psychosocial risk factors in heart disease: less conversation, more action!

Psychosocial factors play a significant role in the incidence and prognosis of cardiovascular disease with a rapidly increasing body of knowledge, as acknowledged by their inclusion in the European Society of Cardiology cardiovascular prevention guideline since 2012. Nevertheless, psychosocial risk is not consistently assessed, acknowledged and treated in daily clinical practice. Therefore, adopting a multidimensional approach that encompasses biological, psychological, and social factors is crucial for understanding the dynamic nature of cardiovascular health and disease, delivering patient-centred care, and developing effective interventions to ultimately enhance health and satisfaction with contemporary medicine and care. The current review summarises the state-of-the-art evidence for screening and treating psychological risk factors in coronary heart disease, heart failure, and atrial fibrillation in the context of cardiac rehabilitation, along with accompanying recommendations. The limited adoption of routine screening, despite longstanding recommendations, highlights the importance of prioritising the implementation and expansion of routine screening in primary and secondary prevention. To advance psychosocial treatment, a standardised and personalised approach including comprehensive education, physical exercise, and psychosocial support with a focus on patient-reported outcomes is crucial. Treating heart and mind together has the potential to decrease psychosocial risk while enhancing the prognosis and quality of life, therefore delivering true patient-centred care.

A Network Analysis of Cardiovascular Risk Factors in Patients With Heart Disease: The Role of Socioeconomic Status and Sex.

OBJECTIVE: Diverse risk factors influence the development and prognosis of coronary heart disease (CHD) independently and mutually. Low socioeconomic status (SES) seems to exacerbate these risk factors' influences. In addition, sex differences have been identified for individual risk factors. Network analysis could provide in-depth insight into the interrelatedness of the risk factors, their predictability, and the moderating role of sex, to ultimately contribute to more refinement in prevention and cardiac rehabilitation. METHODS: A total of 1682 participants (78% male; mean [standard deviation] age = 69.2 [10.6] years) with CHD completed questionnaires on psychosocial factors and health behaviors. Cardiometabolic data were retrieved through medical records. An SES index was created based on self-reported occupation, education, and area (i.e., postal code)-based median family income. Using R, we conducted a mixed graphical model network analysis on all risk factors combined with and without the moderating role of sex. RESULTS: SES belonged to the more influential risk factors with moderate to high levels of expected influence and degree centrality, indicating that it plays a considerable role in the risk factor network. When considering the moderating role of sex, relationships between SES and most risk factors were found to be stronger for women ( b = 0.06-0.48). CONCLUSIONS: The current study provided an insight into an interrelated network of psychosocial and medical risk factors among CHD patients. With SES belonging to the more influential risk factors and female sex influencing the strength of all the SES-risk factor relationships, cardiac rehabilitation and prevention techniques could be more refined by accounting for both influences.

Colorectal cancer and cardiovascular disease: double the burden when it comes to your health-related quality of life?

BACKGROUND: The prevalence of comorbid cardiovascular disease (CVD) among patients with colorectal cancer (CRC) has increased in the last decades. Previous studies have focused on the impact of comorbid CVD on clinical outcomes in CRC, while its impact on patients' health-related quality of life (HRQoL) is understudied. This study, therefore, relates (new-onset) CVD to HRQoL (i.e., physical, role, cognitive, emotional, and social functioning, and two CVD-related symptom scales fatigue and dyspnea) in a two-year follow-up study among CRC patients. MATERIALS AND METHODS: Newly diagnosed CRC patients from four Dutch hospitals were eligible for participation. Patients (N = 327) completed questions on HRQoL (EORTC QLQ-C30) and the presence and timing of CVDs before initial treatment (baseline) and one and two years after diagnosis. RESULTS: CRC patients with comorbid CVD at cancer diagnosis (n = 72, 22%) reported significantly worse physical functioning at 2-year follow-up compared with patients who never had comorbid CVD (p < .05). CRC patients with new-onset CVD (n = 36, 11%) reported worse global QoL, worse role functioning, and more fatigue at 1 and 2-year follow-up compared with patients who never had comorbid CVD. In addition, they reported more dyspnea at baseline and worse physical functioning at 2-year follow-up (p < .05). Finally, patients with new-onset CVD reported worse global quality of life at 1-year follow-up and worse role functioning and more fatigue at 2-year follow-up, compared with patients with comorbid CVD at cancer diagnosis (p < .05). All significant differences between the three groups were of clinical relevance. CONCLUSIONS: CRC patients with CVD, specifically those with new-onset CVD, reported a significantly and clinically relevant worse HRQoL compared with those who never had comorbid CVD. These findings seem to indicate, although the number is small, that CRC patients might have cardiovascular needs that need to be addressed and that multidisciplinary care is recommended. Larger studies are needed to confirm this.

ShareHeart: A patient journey map of patients with ischemia and non-obstructive coronary artery disease based on qualitative research.

AIMS AND OBJECTIVES: To visualise the health care experiences and needs of patients with ischemia with non-obstructive coronary arteries in a patient journey map. As such, future design challenges can be provided, and it can be used for future healthcare optimization. BACKGROUND: Ischemia with non-obstructive coronary arteries is a chronic cardiac condition caused by vascular dysfunctions. Ischemia with non-obstructive coronary arteries is often unrecognised, significantly impairs daily functioning, and is more prevalent among women. Patients' experiences remain unexplored, and a clear patient-centered care pathway is lacking. DESIGN: A qualitative interpretative research design was performed and the standards for reporting qualitative research (SRQR) has been used. METHODS: In total, 36 women were included and participated in eight semi-structured focus group interviews. Thematic analysis was used, and identified themes were further classified using 'patient journey mapping.' Additionally, Picker's 'eight principles of patient-centered care' were linked to the results and integrated in the patient journey map. RESULTS: Participants experienced a lack of familiarity with the specific cardiac condition by healthcare providers, repeated hospitalisation, testing and referrals, shortage of specialised cardiologists, and feelings of not being heard. In addition, needs for a multidisciplinary treatment program (including physical and psychological support), better information provision, and an easily accessible contact person were expressed. CONCLUSIONS: The resulting patient journey map shows how patients experienced and interacted with the current healthcare system. Overall, the results show a complex and long healthcare pathway and important themes for healthcare experiences and needs were identified. Future research could focus on the development and implementation of a patient-centered evidence-based clinical pathway optimising experiences and quality of life. RELEVANCE TO CLINICAL PRACTICE: The visual tool can help health care professionals, policy makers, and researchers improve healthcare provision which is patient-centered and tailored to the preferences of patients with ischemia with non-obstructive coronary arteries.

Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation.

BACKGROUND: Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS: In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS: The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the early-cardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early-cardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS: In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753.).

Facial Emotion Expression and the Inducibility of Myocardial Ischemia During Cardiac Stress Testing: The Role of Psychological Background Factors.

OBJECTIVE: Negative emotional states, such as anger and anxiety, are associated with the onset of myocardial infarction and other acute clinical manifestations of ischemic heart disease. The likelihood of experiencing these short-term negative emotions has been associated with long-term psychological background factors such as depression, generalized anxiety, and personality factors. We examined the association of acute emotional states preceding cardiac stress testing (CST) with inducibility of myocardial ischemia and to what extent psychological background factors account for this association. METHODS: Emotional states were assessed in patients undergoing CST (n = 210; mean [standard deviation] age = 66.9 [8.2] years); 91 (43%) women) using self-report measures and video recordings of facial emotion expression. Video recordings were analyzed for expressed anxiety, anger, sadness, and happiness before CST. Psychological background factors were assessed with validated questionnaires. Single-photon emission computed tomography was used to evaluate inducibility of ischemia. RESULTS: Ischemia occurred in 72 patients (34%). Emotional states were not associated with subsequent inducibility of ischemia during CST (odds ratio between 0.93 and 1.04; p values > .50). Psychological background factors were also not associated with ischemia (odds ratio between 0.96 and 1.06 per scale unit; p values > .20) and did not account for the associations of emotional states with ischemia. CONCLUSIONS: Emotional states immediately before CST and psychological background factors were not associated with the inducibility of ischemia. These findings indicate that the well-documented association between negative emotions with acute clinical manifestations of ischemic heart disease requires a different explanation than a reduced threshold for inducible ischemia.

Psychological factors of suspect coronary microvascular dysfunction in patients undergoing SPECT imaging.

BACKGROUND: Patients with myocardial ischemia in the absence of obstructive coronary artery disease (CAD) often experience anginal complaints and are at risk of cardiac events. Stress-related psychological factors and acute negative emotions might play a role in these patients with suspect coronary microvascular dysfunction (CMD). METHODS AND RESULTS: 295 Patients (66.9 ± 8.7 years, 46% women) undergoing myocardial perfusion single-photon-emission computed tomography (MPI-SPECT), were divided as follows: (1) a non-ischemic reference group (n = 136); (2) patients without inducible ischemia, but with a history of CAD (n = 62); (3) ischemia and documented CAD (n = 52); and (4) ischemia and suspect CMD (n = 45). These four groups were compared with regard to psychological factors and acute emotions. Results revealed no differences between the groups in psychological factors (all P > .646, all effect sizes d < .015). State sadness was higher for patients with suspect CMD (16%) versus the other groups (P = .029). The groups did not differ in the association of psychological factors or emotions with anginal complaints (all P values > .448). CONCLUSION: Suspect CMD was not associated with more negative psychological factors compared to other groups. State sadness was significantly higher for patients with suspect CMD, whereas no differences in state anxiety and other psychological factors were found.

Anxiety and hemodynamic reactivity during cardiac stress testing: The role of gender and age in myocardial ischemia.

BACKGROUND: The prevalence of myocardial ischemia is associated with anxiety. State and trait anxiety are more common in younger women compared to men, and high anxiety levels could affect hemodynamic reactivity during cardiac stress testing. The aim is to examine whether anxiety plays a role in gender differences in patients ≤ 65 and > 65 years in hemodynamic reactivity and ischemia during cardiac stress testing. METHODS AND RESULTS: Included were 291 patients (66.8 ± 8.7 years, 45% women) with suspect ischemia undergoing myocardial perfusion single-photon emission computed tomography (MPI-SPECT). Primary outcomes were semi-quantitative summed difference score (SDS) and summed stress score (SSS), as continuous indicators of myocardial ischemia. Analyses were stratified by age. Trait anxiety was measured using a validated questionnaire (GAD-7) and state anxiety using facial expression analyses software. Overall, trait and state anxiety were not associated with the prevalence of ischemia (N = 107, 36%). A significant interaction was found between gender and trait anxiety in women ≤ 65 years for SDS (F(1,4) = 5.73, P = .019) and SSS (F(1,10) = 6.50, P = .012). This was not found for state anxiety. CONCLUSION: SDS and SSS were significantly higher in women younger than 65 years with high trait anxiety. This interaction was not found in men and women over 65 years.

Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death.

AIMS: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation. METHODS AND RESULTS: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality. CONCLUSION: Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.

Facial Expressions of Emotions During Pharmacological and Exercise Stress Testing: the Role of Myocardial Ischemia and Cardiac Symptoms.

BACKGROUND: Negative emotions have been linked to ischemic heart disease, but existing research typically involves self-report methods and little is known about non-verbal facial emotion expression. The role of ischemia and anginal symptoms in emotion expression was examined. METHODS: Patients undergoing cardiac stress testing (CST) using bicycle exercise or adenosine with myocardial perfusion imaging were included (N = 256, mean age 66.8 ± 8.7 year., 43% women). Video images and emotion expression (sadness, anxiety, anger, and happiness) were analyzed at baseline, initial CST , maximal CST, recovery. Nuclear images were evaluated using SPECT. RESULTS: Ischemia (N = 89; 35%) was associated with higher levels of sadness (p = .017, d = 0.34) and lower happiness (p = .015, d = 0.30). During recovery, patients with both ischemia and anginal symptoms had the highest sadness expression (F (3,254) = 3.67, p = .013, eta2 = 0.042) and the lowest happiness expression (F (3, 254) = 4.19, p = .006, eta2 = .048). CONCLUSION: Sadness and reduced happiness were more common in patients with ischemia. Also, anginal symptoms were associated with more negative emotions.

Personalized eHealth Program for Life-style Change: Results From the "Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)" Randomized Controlled Trial.

OBJECTIVE: Unhealthy life-style factors have adverse outcomes in cardiac patients. However, only a minority of patients succeed to change unhealthy habits. Personalization of interventions may result in critical improvements. The current randomized controlled trial provides a proof of concept of the personalized Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) 2 intervention and evaluates effects on a) life-style and b) quality of life over time. METHODS: Cardiac patients (n = 150; mean age = 61.97 ± 11.61 years; 28.7% women; heart failure, n = 33; coronary artery disease, n = 50; hypertension, n = 67) recruited from Spain and the Netherlands were randomized to either the "Do CHANGE 2" or "care as usual" group. The Do CHANGE 2 group received ambulatory health-behavior assessment technologies for 6 months combined with a 3-month behavioral intervention program. Linear mixed-model analysis was used to evaluate the intervention effects, and latent class analysis was used for secondary subgroup analysis. RESULTS: Linear mixed-model analysis showed significant intervention effects for life-style behavior (Finteraction(2,138.5) = 5.97, p = .003), with improvement of life-style behavior in the intervention group. For quality of life, no significant main effect (F(1,138.18) = .58, p = .447) or interaction effect (F(2,133.1) = 0.41, p = .67) was found. Secondary latent class analysis revealed different subgroups of patients per outcome measure. The intervention was experienced as useful and feasible. CONCLUSIONS: The personalized eHealth intervention resulted in significant improvements in life-style. Cardiac patients and health care providers were also willing to engage in this personalized digital behavioral intervention program. Incorporating eHealth life-style programs as part of secondary prevention would be particularly useful when taking into account which patients are most likely to benefit. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03178305.

A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial.

BACKGROUND: Behavior change methods involving new ambulatory technologies may improve lifestyle and cardiovascular disease outcomes. OBJECTIVE: This study aimed to provide proof-of-concept analyses of an intervention aiming to increase (1) behavioral flexibility, (2) lifestyle change, and (3) quality of life. The feasibility and patient acceptance of the intervention were also evaluated. METHODS: Patients with cardiovascular disease (N=149; mean age 63.57, SD 8.30 years; 50/149, 33.5% women) were recruited in the Do Cardiac Health Advanced New Generation Ecosystem (Do CHANGE) trial and randomized to the Do CHANGE intervention or care as usual (CAU). The intervention involved a 3-month behavioral program in combination with ecological momentary assessment and intervention technologies. RESULTS: The intervention was perceived to be feasible and useful. A significant increase in lifestyle scores over time was found for both groups (F2,146.6=9.99; P<.001), which was similar for CAU and the intervention group (F1,149.9=0.09; P=.77). Quality of life improved more in the intervention group (mean 1.11, SD 0.11) than CAU (mean -1.47, SD 0.11) immediately following the intervention (3 months), but this benefit was not sustained at the 6-month follow-up (interaction: P=.02). No significant treatment effects were observed for behavioral flexibility (F1,149.0=0.48; P=.07). CONCLUSIONS: The Do CHANGE 1 intervention was perceived as useful and easy to use. However, no long-term treatment effects were found on the outcome measures. More research is warranted to examine which components of behavioral interventions are effective in producing long-term behavior change. TRIAL REGISTRATION: ClinicalTrials.gov NCT02946281; https://www.clinicaltrials.gov/ct2/show/NCT02946281.

Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial.

BACKGROUND: During the last few decades, preventing the development of cardiovascular disease has become a mainstay for reducing cardiovascular morbidity and mortality. It has been suggested that interventions should focus more on committed approaches of self-care, such as electronic health techniques. OBJECTIVE: This study aimed to provide evidence to understand the financial consequences of implementing the "Do Cardiac Health: Advanced New Generation Ecosystem" (Do CHANGE 2) intervention, which was evaluated in a multisite randomized controlled trial to change the health behavior of patients with cardiovascular disease. METHODS: The cost-effectiveness analysis of the Do CHANGE 2 intervention was performed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, based on a Markov model of five health states. The following two types of costs were considered for both study groups: (1) health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities). RESULTS: The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively). Compared with treatment as usual, the effectiveness of the Do CHANGE 2 program in terms of an increase in quality-adjusted life-year gains was slightly higher in the Netherlands and lower in Spain and Taiwan. CONCLUSIONS: In general, we found that the incremental cost-effectiveness ratio strongly varied depending on the country where the intervention was applied. The Do CHANGE 2 intervention showed a positive cost-effectiveness ratio only when implemented in Spain, indicating that it saved financial costs in relation to the effect of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305.

Effect of remote monitoring on patient-reported outcomes in European heart failure patients with an implantable cardioverter-defibrillator: primary results of the REMOTE-CIED randomized trial.

AIMS: The European REMOTE-CIED study is the first randomized trial primarily designed to evaluate the effect of remote patient monitoring (RPM) on patient-reported outcomes in the first 2 years after implantation of an implantable cardioverter-defibrillator (ICD). METHODS AND RESULTS: The sample consisted of 595 European heart failure patients implanted with an ICD compatible with the Boston Scientific LATITUDE® RPM system. Patients were randomized to RPM plus a yearly in-clinic ICD check-up vs. 3-6-month in-clinic check-ups alone. At five points during the 2-year follow-up, patients completed questionnaires including the Kansas City Cardiomyopathy Questionnaire and Florida Patient Acceptance Survey (FPAS) to assess their heart failure-specific health status and ICD acceptance, respectively. Information on clinical status was obtained from patients' medical records. Linear regression models were used to compare scores between groups over time. Intention-to-treat and per-protocol analyses showed no significant group differences in patients' health status and ICD acceptance (subscale) scores (all Ps > 0.05). Exploratory subgroup analyses indicated a temporary improvement in device acceptance (FPAS total score) at 6-month follow-up for secondary prophylactic in-clinic patients only (P < 0.001). No other significant subgroup differences were observed. CONCLUSION: Large clinical trials have indicated that RPM can safely and effectively replace most in-clinic check-ups of ICD patients. The REMOTE-CIED trial results show that patient-reported health status and ICD acceptance do not differ between patients on RPM and patients receiving in-clinic check-ups alone in the first 2 years after ICD implantation.ClinicalTrials.gov Identifier: NCT01691586.

Healthcare utilization in patients with first-time implantable cardioverter defibrillators (data from the WEBCARE study).

BACKGROUND: Knowledge of the level of healthcare utilization (HCU) and the predictors of high HCU use in patients with an implantable cardioverter defibrillator (ICD) is lacking. We examined the level of HCU and predictors associated with increased HCU in first-time ICD patients, using a prospective study design. METHODS: ICD patients (N = 201) completed a set of questionnaires at baseline and 3, 6, and 12 months after inclusion. A hierarchical multiple linear regression with three models was performed to examine predictors of HCU. RESULTS: HCU was highest between baseline and 3 months postimplantation and gradually decreased during 12 months follow-up. During the first year postimplantation, only depression (ß = 0.342, P = 0.002) was a significant predictor. Between baseline and 3 months follow-up, younger age (ß = -0.220, P < 0.01), New York Heart Association class III/IV (ß = 0.705, P = 0.01), and secondary indication (ß = 0.148, P = 0.05) were independent predictors for increased HCU. Between 3 and 6 months follow-up, younger age (ß = -0.151, P = 0.05) and depression (ß = 0.370, P < 0.001) predicted increased HCU. Between 6 and 12 months only depression (ß = 0.355, P = 0.001) remained a significant predictor. CONCLUSIONS: Depression was an important predictor of increased HCU in ICD patients in the first year postimplantation, particularly after 3 months postimplantation. Identifying patients who need additional care and provide this on time might better meet patients' needs and lower future HCU.

Self-Care and Pathophysiological Function in Patients with Chronic Heart Failure.

BACKGROUND: Self-care is assumed to benefit physiological function associated with prognosis in patients with chronic HF, but studies examining these relations are lacking. This study aims to prospectively examine the association of self-reported HF self-care with HF-associated pathophysiological markers, including renal, hematological, and immune function. METHOD: Patients with chronic HF (n = 460, 66.2 ± 9.6 years, 75% men) completed questionnaires and provided blood samples at baseline and 12-month follow-up. Linear mixed models examined random intercept and fixed between- and within-subjects effects of global self-care and the individual self-care behaviors on log-transformed TNF-α, IL-6, and IL-10, the glomerular filtration rate of creatinine (GFRcreat), and hemoglobin (Hb), controlling for sociodemographic and clinical covariates. RESULTS: Self-care was independently associated with lower GFRcreat levels (ß = - .14, P = .023) and improvement in self-care with a reduction in GFRcreat (ß = - .03, P = .042). Individual self-care behaviors were differentially associated with renal, inflammatory, and hematological markers. Regular exercise was associated with level differences in IL-6 (P < .001), and improvement in exercise was associated with increasing GFRcreat (P = .002) and increasing Hb (P = .010). Fluid restriction was associated with lower overall GFRcreat (P = .006), and improvement in fluid restriction was associated with decreasing GFRcreat (P = .014). Low-sodium intake was associated with lower levels of Hb (P = .027), lower TNF-alpha (P = .011), and lower IL-10 (P = .029). Higher levels of medication adherence were associated with reduced pro-inflammatory activation (P < .007). CONCLUSION: Our findings suggest that better global self-care was associated with poorer renal function. Performing self-care behaviors such as regular exercise and medication adherence was associated with improved physiological functioning, while restriction of fluid and sodium, and the associated daily weight monitoring were associated with adverse levels of pathophysiological biomarkers.

Acute cardioversion vs a wait-and-see approach for recent-onset symptomatic atrial fibrillation in the emergency department: Rationale and design of the randomized ACWAS trial.

BACKGROUND: Current standard of care for patients with recent-onset atrial fibrillation (AF) in the emergency department aims at urgent restoration of sinus rhythm, although paroxysmal AF is a condition that resolves spontaneously within 24 hours in more than 70% of the cases. A wait-and-see approach with rate-control medication only and when needed cardioversion within 48 hours of onset of symptoms is hypothesized to be noninferior, safe, and cost-effective as compared with current standard of care and to lead to a higher quality of life. DESIGN: The ACWAS trial (NCT02248753) is an investigator-initiated, randomized, controlled, 2-arm noninferiority trial that compares a wait-and-see approach to the standard of care. Consenting adults with recent-onset symptomatic AF in the emergency department without urgent need for cardioversion are eligible for participation. A total of 437 patients will be randomized to either standard care (pharmacologic or electrical cardioversion) or the wait-and-see approach, consisting of symptom reduction through rate control medication until spontaneous conversion is achieved, with the possibility of cardioversion within 48 hours after onset of symptoms. Primary end point is the presence of sinus rhythm on 12-lead electrocardiogram at 4 weeks; main secondary outcomes are adverse events, total medical and societal costs, quality of life, and cost-effectiveness for 1 year. CONCLUSIONS: The ACWAS trial aims at providing evidence for the use of a wait-and-see approach for patients with recent-onset symptomatic AF in the emergency department.

Validity of the European Society of Cardiology's Psychosocial Screening Interview in Patients With Coronary Artery Disease-The THORESCI Study.

OBJECTIVE: The aim of the study was to examine the validity of the European Society of Cardiology (ESC) psychosocial screening instrument. METHODS: A total of 508 acute (67%) or elective (33%) percutaneous coronary intervention patients (mean [standard deviation]age = 63 [10] years, 81% male) completed the ESC screening interview and established questionnaires for psychosocial risk markers, that is, depression (Patient Health Questionnaire 9), anxiety (Generalized Anxiety Disorder Questionnaire 7), type D personality (Type D Scale 14), hostility (Cook-Medley Hostility Scale 7), and marital/work stress (Maudsley Marital Quality Questionnaire 6, Effort-Reward Imbalance Scale) during or close after hospital admission. At 1-year follow-up, angina and cardiopulmonary symptoms were assessed. RESULTS: Prevalence estimates of psychosocial factors based on the ESC screener were as follows: depression (18%), anxiety (33%), negative affectivity (11%), social inhibition (41%), work stress (17%), marital stress (2%), and hostility (38%). Analysis of correspondence with validated questionnaires revealed fair to moderate agreement (depression [κ = .39], anxiety [κ = .23], type D personality [κ = .21]), regardless of percutaneous coronary intervention indication. For work and marital stress, there was poor to fair performance (κ range = .04-.24); agreement for hostility was poor (κ = -.27). A positive ESC screen for depression, anxious tension, and type D personality was associated with more angina and cardiopulmonary symptoms at follow-up (odds ratios ranging between 1.85 (95% confidence interval = 0.84-4.08) and 8.01 (95% confidence interval = 2.35-27.35). CONCLUSIONS: The ESC screener contributes to the search for a multidimensional and easy-to-use psychosocial screening instrument for cardiac patients. Although the screener, in its current form, may not be sufficiently valid to reliably detect all predefined psychosocial factors, screening scores for depression and anxiety might be useful in clinical practice. Our findings can be used for further refinement and validation of the screener.