Wearable Devices, Health Care Use, and Psychological Well-Being in Patients With Atrial Fibrillation.

BACKGROUND: Wearables are increasingly used by patients with atrial fibrillation (AF) for symptom monitoring and health management, but their impact on patient health care use and psychological well-being is not well understood. METHODS AND RESULTS: In this retrospective, propensity-matched study of patients with AF, survey and electronic health record data were merged to compare AF-specific health care use (outpatient/inpatient visits, rhythm-related testing, and procedures) and informal health care use (telephone calls and patient portal messages) over a 9-month period between wearable users and nonusers. We also examined the effects of wearable cardiac monitoring features (eg, heart rate alerts, irregular rhythm notification, and ECG) on patient behavior and well-being. Of 172 patients with AF in this analysis (age, 72.6±9.0 years; 42% women), 83 used a wearable. Compared with nonusers, wearable users reported higher rates of symptom monitoring and preoccupation (P=0.03) and more AF treatment concerns (P=0.02). Moreover, 20% of wearable users experienced anxiety and always contacted their doctors in response to irregular rhythm notifications. After matching, AF-specific health care use was significantly greater among wearable users compared with nonusers (P=0.04), including significantly higher rates of ECGs, echocardiograms/transesophageal echocardiogram, and ablation. Wearable users were also significantly more likely to use informal health care resources compared with nonusers (P=0.05). CONCLUSIONS: Wearables were associated with higher rates of symptom monitoring and preoccupation, AF treatment concerns, AF-specific health care use, and use of informal health care resources. Prospective, randomized studies are needed to understand the net effects of wearables and their alerts on patients, providers, and the health care system.

From transthyretin cardiac amyloidosis diagnosis to tafamidis treatment: Association of drop-off with patient sociodemographic characteristics.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: Compared to estimated population prevalence rates, relatively few patients at risk are diagnosed with and treated for transthyretin cardiac amyloidosis (ATTR-CA). Where along the clinical pathway patient drop-off occurs, as well as the association of drop-off with patient sociodemographic characteristics, remains unknown. METHODS: Using data from a healthcare system-wide cardiovascular imaging repository and specialty pharmacy, we characterized the clinical pathway from diagnosis with pyrophosphate scintigraphy (PYP) to tafamidis prescription, initiation, and adherence. Standardized differences (d values of ≥0.20, indicating at least a small effect size) were used to compare sociodemographics (age, sex, race, Area Deprivation Index) among patients with PYP-identified ATTR-CA by tafamidis prescription status and among patients prescribed tafamidis by initiation status. Tafamidis adherence was measured with the proportion of days covered (PDC). RESULTS: Of 97 patients with ATTR-CA, 58.8% were prescribed tafamidis, with 80.7% of those initiating therapy. Patients with ATTR-CA prescribed tafamidis were younger than those not prescribed tafamidis (d = -0.30). Utilization of a specialty pharmacy resulted in enrichment of treatment in subgroups traditionally undertreated in cardiovascular medicine, with higher rates of tafamidis initiation among women (100% initiation), patients of Black/African American race (d = 0.40), and those living in more economically disadvantaged areas (d ≥ 0.30). Adherence was high (PDC of >80%) in 88.4% of those initiating tafamidis. CONCLUSION: These findings highlight the tremendous opportunity for more robust ATTR-CA clinical programs, identifying potential patient subgroups that should be targeted to reduce disparities. For patients diagnosed with ATTR-CA, utilization of a specialty pharmacy process appears to ensure equitable provision of tafamidis therapy.

Electronic Health Record Concordance with Survey-Reported Military Sexual Trauma Among Younger Veterans: Associations with Health Care Utilization and Mental Health Diagnoses.

Introduction: Military sexual trauma (MST) is more common among post-9/11 Veterans and women versus older Veterans and men. Despite mandatory screening, the concordance of electronic health record (EHR) documentation and survey-reported MST, and associations with health care utilization and mental health diagnoses, are unknown for this younger group. Materials and Methods: Veterans' Health Administration (VHA) EHR (2001-2021) were merged with data from the observational, nationwide WomenVeterans Cohort Study (collected 2016-2020, n = 1058; 51% women). Experiencing MST was defined as positive endorsement of sexual harassment and/or assault. From the EHR, we derived Veterans' number of primary care and mental health visits in the initial two years of VHA care and diagnoses of posttraumatic stress disorder (PTSD), depression, and anxiety. First, the concordance of EHR MST screening and survey-reported MST was compared. Next, multivariate analyses tested the cross-sectional associations of EHR screening and survey-reported MST with Veterans' health care utilization, and compared the likelihood of PTSD, depression, and anxiety diagnoses by MST group, while covarying demographics and service-related characteristics. With few MST cases among men, multivariate analyses were only pursued for women. Results: Overall, 29% of women and 2% of men screened positive for MST in the EHR, but 64% of women and 9% of men had survey-reported MST. Primary care utilization was similar between women with concordant, positive MST reports in the EHR and survey versus those with survey-reported MST only. Women with survey-reported MST only were less likely to have a PTSD or depression diagnosis than those with concordant, positive MST reports. There was no group difference in women's likelihood of anxiety. Conclusions: EHR MST documentation is discordant for many post-9/11 Veterans-both for men and women. Improving MST screening and better supporting MST disclosure are each critical to provide appropriate and timely care for younger Veterans, particularly women.

Vigorous Exercise in Patients With Congenital Long QT Syndrome: Results of the Prospective, Observational, Multinational LIVE-LQTS Study.

BACKGROUND: Whether vigorous exercise increases risk of ventricular arrhythmias for individuals diagnosed and treated for congenital long QT syndrome (LQTS) remains unknown. METHODS: The National Institutes of Health-funded LIVE-LQTS study (Lifestyle and Exercise in the Long QT Syndrome) prospectively enrolled individuals 8 to 60 years of age with phenotypic and/or genotypic LQTS from 37 sites in 5 countries from May 2015 to February 2019. Participants (or parents) answered physical activity and clinical events surveys every 6 months for 3 years with follow-up completed in February 2022. Vigorous exercise was defined as ≥6 metabolic equivalents for >60 hours per year. A blinded Clinical Events Committee adjudicated the composite end point of sudden death, sudden cardiac arrest, ventricular arrhythmia treated by an implantable cardioverter defibrillator, and likely arrhythmic syncope. A National Death Index search ascertained vital status for those with incomplete follow-up. A noninferiority hypothesis (boundary of 1.5) between vigorous exercisers and others was tested with multivariable Cox regression analysis. RESULTS: Among the 1413 participants (13% <18 years of age, 35% 18-25 years of age, 67% female, 25% with implantable cardioverter defibrillators, 90% genotype positive, 49% with LQT1, 91% were treated with beta-blockers, left cardiac sympathetic denervation, and/or implantable cardioverter defibrillator), 52% participated in vigorous exercise (55% of these competitively). Thirty-seven individuals experienced the composite end point (including one sudden cardiac arrest and one sudden death in the nonvigorous group, one sudden cardiac arrest in the vigorous group) with overall event rates at 3 years of 2.6% in the vigorous and 2.7% in the nonvigorous exercise groups. The unadjusted hazard ratio for experience of events for the vigorous group compared with the nonvigorous group was 0.97 (90% CI, 0.57-1.67), with an adjusted hazard ratio of 1.17 (90% CI, 0.67-2.04). The upper 95% one-sided confidence level extended beyond the 1.5 boundary. Neither vigorous or nonvigorous exercise was found to be superior in any group or subgroup. CONCLUSIONS: Among individuals diagnosed with phenotypic and/or genotypic LQTS who were risk assessed and treated in experienced centers, LQTS-associated cardiac event rates were low and similar between those exercising vigorously and those not exercising vigorously. Consistent with the low event rate, CIs are wide, and noninferiority was not demonstrated. These data further inform shared decision-making discussions between patient and physician about exercise and competitive sports participation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02549664.

Translational Research of the Acute Effects of Negative Emotions on Vascular Endothelial Health: Findings From a Randomized Controlled Study.

BACKGROUND: Provoked anger is associated with an increased risk of cardiovascular disease events. The underlying mechanism linking provoked anger as well as other core negative emotions including anxiety and sadness to cardiovascular disease remain unknown. The study objective was to examine the acute effects of provoked anger, and secondarily, anxiety and sadness on endothelial cell health. METHODS AND RESULTS: Apparently healthy adult participants (n=280) were randomized to an 8-minute anger recall task, a depressed mood recall task, an anxiety recall task, or an emotionally neutral condition. Pre-/post-assessments of endothelial health including endothelium-dependent vasodilation (reactive hyperemia index), circulating endothelial cell-derived microparticles (CD62E+, CD31+/CD42-, and CD31+/Annexin V+) and circulating bone marrow-derived endothelial progenitor cells (CD34+/CD133+/kinase insert domain receptor+ endothelial progenitor cells and CD34+/kinase insert domain receptor+ endothelial progenitor cells) were measured. There was a group×time interaction for the anger versus neutral condition on the change in reactive hyperemia index score from baseline to 40 minutes (P=0.007) with a mean±SD change in reactive hyperemia index score of 0.20±0.67 and 0.50±0.60 in the anger and neutral conditions, respectively. For the change in reactive hyperemia index score, the anxiety versus neutral condition group by time interaction approached but did not reach statistical significance (P=0.054), and the sadness versus neutral condition group by time interaction was not statistically significant (P=0.160). There were no consistent statistically significant group×time interactions for the anger, anxiety, and sadness versus neutral condition on endothelial cell-derived microparticles and endothelial progenitor cells from baseline to 40 minutes. CONCLUSIONS: In this randomized controlled experimental study, a brief provocation of anger adversely affected endothelial cell health by impairing endothelium-dependent vasodilation.

Blood Pressure Control and Maintenance in a Prospective Cohort of Younger Veterans: Roles of Sex, Race, Ethnicity, and Social Determinants of Health.

Background: Proactive blood pressure (BP) management is particularly beneficial for younger Veterans, who have a greater prevalence and earlier onset of cardiovascular disease than non-Veterans. It is unknown what proportion of younger Veterans achieve and maintain BP control after hypertension onset and if BP control differs by demographics and social deprivation. Methods: Electronic health records were merged from Veterans who enrolled in VA care 10/1/2001-9/30/2017 and met criteria for hypertension - first diagnosis or antihypertensive fill. BP control (140/90 mmHg), was estimated 1, 2, and 5 years post-hypertension documentation, and characterized by sex, race, and ethnicity. Adjusted logistic regressions assessed likelihood of BP control by these demographics and with the Social Deprivation Index (SDI). Results: Overall, 17% patients met criteria for hypertension (n=198,367; 11% of women, median age 41). One year later, 59% of men and 65% of women achieved BP control. After adjustment, women had a 72% greater odds of BP control than men, with minimal change over 5 years. Black adults had a 22% lower odds of BP control than White adults. SDI did not significantly change these results. Conclusions: In the largest study of hypertension in younger Veterans, 41% of men and 35% of women did not have BP control after 1 year, and BP control was consistently better for women through 5 years. Thus, the first year of hypertension management portends future, long-term BP control. As social deprivation did not affect BP control, the VA system may protect against disadvantages observed in the general U.S. population.

Use of a Single-Item Ecological Momentary Assessment to Measure Daily Exercise: Agreement with Accelerometer-Measured Exercise.

Accelerometers have been used to objectively quantify physical activity, but they can pose a high burden. This study was conducted to determine the feasibility of using a single-item smartphone-based ecological momentary assessment (EMA) in lieu of accelerometers in long-term assessment of daily exercise. Data were collected from a randomized controlled trial of intermittently exercising, otherwise healthy adults (N = 79; 57% female, mean age: 31.9 ± 9.5 years) over 365 days. Smartphone-based EMA self-reports of exercise entailed daily end-of-day responses about physical activity; the participants also wore a Fitbit device to measure physical activity. The Kappa statistic was used to quantify the agreement between accelerometer-determined (24 min of moderate-to-vigorous physical activity [MVPA] within 30 min) and self-reported exercise. Possible demographic predictors of agreement were assessed. Participants provided an average of 164 ± 87 days of complete data. The average within-person Kappa was κ = 0.30 ± 0.22 (range: -0.15-0.73). Mean Kappa ranged from 0.16 to 0.30 when the accelerometer-based definition of an exercise bout varied in duration from 15 to 30 min of MVPA within any 30 min period. Among the correlates examined, sex was significantly associated with agreement; mean agreement was higher among women (κ = 0.37) than men (κ = 0.20). Agreement between EMA self-reported and accelerometer-measured exercise was fair, suggesting that long-term exercise monitoring through a single-item EMA may be acceptable.

Opioid prescription and risk of atrial fibrillation in younger veterans.

BACKGROUND: Opioids may play a part in the development of atrial fibrillation (AF). Understanding the relationship between opioid exposure and AF can help providers better assess the risk and benefits of prescribing opioids. OBJECTIVE: To assess the incidence of AF as a function of prescribed opioids and opioid type. DESIGN: We performed unadjusted and adjusted time-updated Cox regressions to assess the association between opioid exposure and incident AF. PARTICIPANTS: The national study sample was comprised of Veterans enrolled in the Veterans Health Administration (VHA) who served in support of post-9/11 operations. MAIN MEASURES: The main predictor of interest was prescription opioid exposure, which was treated as a time-dependent variable. The first was any opioid exposure (yes/no). Secondary was opioid type. The outcome, incident AF, was identified through ICD-9-CM diagnostic codes at any primary care visit after the baseline period. KEY RESULTS: A total of 609,763 veterans (mean age: 34 years and 13.24% female) were included in our study. Median follow-up time was 4.8 years. Within this cohort, 124,395 veterans (20.40%) were prescribed an opioid. A total of 1,455 Veterans (0.24%) were diagnosed with AF. In adjusted time-updated Cox regressions, the risk of incident AF was higher in the veterans prescribed opioids (hazard ratio [HR]: 1.47; 95% confidence interval [CI]: 1.38-1.57). In adjusted time-updated Cox regressions, both immunomodulating and nonimmunomodulating opioid type was associated with increased risk of incident AF (HR: 1.40; 95% CI: 1.25-1.57 and HR: 1.49; 95% CI: 1.39-1.60), compared to no opioid use, respectively. CONCLUSIONS: Our findings suggest opioid prescription may be a modifiable risk factor for the development of AF.

Insomnia and Early Incident Atrial Fibrillation: A 16-Year Cohort Study of Younger Men and Women Veterans.

Background There is growing consideration of sleep disturbances and disorders in early cardiovascular risk, including atrial fibrillation (AF). Obstructive sleep apnea confers risk for AF but is highly comorbid with insomnia, another common sleep disorder. We sought to first determine the association of insomnia and early incident AF risk, and second, to determine if AF onset is earlier among those with insomnia. Methods and Results This retrospective analysis used electronic health records from a cohort study of US veterans who were discharged from military service since October 1, 2001 (ie, post-9/11) and received Veterans Health Administration care, 2001 to 2017. Time-varying, multivariate Cox proportional hazard models were used to examine the independent contribution of insomnia diagnosis to AF incidence while serially adjusting for demographics, lifestyle factors, clinical comorbidities including obstructive sleep apnea and psychiatric disorders, and health care utilization. Overall, 1 063 723 post-9/11 veterans (Mean age=28.2 years, 14% women) were followed for 10 years on average. There were 4168 cases of AF (0.42/1000 person-years). Insomnia was associated with a 32% greater adjusted risk of AF (95% CI, 1.21-1.43), and veterans with insomnia showed AF onset up to 2 years earlier. Insomnia-AF associations were similar after accounting for health care utilization (adjusted hazard ratio [aHR], 1.27 [95% CI, 1.17-1.39]), excluding veterans with obstructive sleep apnea (aHR, 1.38 [95% CI, 1.24-1.53]), and among those with a sleep study (aHR, 1.26 [95% CI, 1.07-1.50]). Conclusions In younger adults, insomnia was independently associated with incident AF. Additional studies should determine if this association differs by sex and if behavioral or pharmacological treatment for insomnia attenuates AF risk.

Classification of blood pressure during sleep impacts designation of nocturnal nondipping.

The identification of nocturnal nondipping blood pressure (< 10% drop in mean systolic blood pressure from awake to sleep periods), as captured by ambulatory blood pressure monitoring, is a valuable element of risk prediction for cardiovascular disease, independent of daytime or clinic blood pressure measurements. However, capturing measurements, including determination of wake/sleep periods, is challenging. Accordingly, we sought to evaluate the impact of different definitions and algorithms for defining sleep onset on the classification of nocturnal nondipping. Using approaches based upon participant self-reports, applied definition of a common sleep period (12 am -6 am), manual actigraphy, and automated actigraphy we identified changes to the classification of nocturnal nondipping, and conducted a secondary analysis on the potential impact of an ambulatory blood pressure monitor on sleep. Among 61 participants in the Eastern Caribbean Health Outcomes Research Network hypertension study with complete ambulatory blood pressure monitor and sleep data, the concordance for nocturnal nondipping across methods was 0.54 by Fleiss' Kappa (depending on the method, 36 to 51 participants classified as having nocturnal nondipping). Sleep quality for participants with dipping versus nondipping was significantly different for total sleep length when wearing the ambulatory blood pressure monitor (shorter sleep duration) versus not (longer sleep duration), although there were no differences in sleep efficiency or disturbances. These findings indicate that consideration of sleep time measurements is critical for interpreting ambulatory blood pressure. As technology advances to detect blood pressure and sleep patterns, further investigation is needed to determine which method should be used for diagnosis, treatment, and future cardiovascular risk.

Vigorous Exercise in Patients With Hypertrophic Cardiomyopathy.

Importance: Whether vigorous intensity exercise is associated with an increase in risk of ventricular arrhythmias in individuals with hypertrophic cardiomyopathy (HCM) is unknown. Objective: To determine whether engagement in vigorous exercise is associated with increased risk for ventricular arrhythmias and/or mortality in individuals with HCM. The a priori hypothesis was that participants engaging in vigorous activity were not more likely to have an arrhythmic event or die than those who reported nonvigorous activity. Design, Setting, and Participants: This was an investigator-initiated, prospective cohort study. Participants were enrolled from May 18, 2015, to April 25, 2019, with completion in February 28, 2022. Participants were categorized according to self-reported levels of physical activity: sedentary, moderate, or vigorous-intensity exercise. This was a multicenter, observational registry with recruitment at 42 high-volume HCM centers in the US and internationally; patients could also self-enroll through the central site. Individuals aged 8 to 60 years diagnosed with HCM or genotype positive without left ventricular hypertrophy (phenotype negative) without conditions precluding exercise were enrolled. Exposures: Amount and intensity of physical activity. Main Outcomes and Measures: The primary prespecified composite end point included death, resuscitated sudden cardiac arrest, arrhythmic syncope, and appropriate shock from an implantable cardioverter defibrillator. All outcome events were adjudicated by an events committee blinded to the patient's exercise category. Results: Among the 1660 total participants (mean [SD] age, 39 [15] years; 996 male [60%]), 252 (15%) were classified as sedentary, and 709 (43%) participated in moderate exercise. Among the 699 individuals (42%) who participated in vigorous-intensity exercise, 259 (37%) participated competitively. A total of 77 individuals (4.6%) reached the composite end point. These individuals included 44 (4.6%) of those classified as nonvigorous and 33 (4.7%) of those classified as vigorous, with corresponding rates of 15.3 and 15.9 per 1000 person-years, respectively. In multivariate Cox regression analysis of the primary composite end point, individuals engaging in vigorous exercise did not experience a higher rate of events compared with the nonvigorous group with an adjusted hazard ratio of 1.01. The upper 95% 1-sided confidence level was 1.48, which was below the prespecified boundary of 1.5 for noninferiority. Conclusions and Relevance: Results of this cohort study suggest that among individuals with HCM or those who are genotype positive/phenotype negative and are treated in experienced centers, those exercising vigorously did not experience a higher rate of death or life-threatening arrhythmias than those exercising moderately or those who were sedentary. These data may inform discussion between the patient and their expert clinician around exercise participation.

The Perceived Stress Scale as a Measure of Stress: Decomposing Score Variance in Longitudinal Behavioral Medicine Studies.

BACKGROUND: The Perceived Stress Scale (PSS) is a widely used measure designed to assess perceptions of recent stress. However, it is unclear to what extent the construct assessed by the PSS represents factors that are stable versus variable within individuals, and how these components might vary over time. PURPOSE: Determine the degree to which variability in repeated PSS assessments is attributable to between-person versus within-person variance in two different studies and populations. METHODS: Secondary analyses utilized data from two studies with up to 13 PSS assessments: An observational study of 127 patients with heart failure followed over 39 months (Study 1), and an experimental study of 73 younger, healthy adults followed over 12 months (Study 2). Multilevel linear mixed modeling was used to estimate sources of variance in the PSS total and subscale scores across assessments. RESULTS: Between-person variance accounted for a large proportion of the total variance in PSS total scores in Study 1 (42.3%) and Study 2 (51.1%); within-person variance comprised the remainder. Between-person variance was higher for shorter assessment periods (e.g., 1 week), and was comparable when examining only the first 12 months of assessments in each study (52.9% vs. 51.1%). CONCLUSIONS: Within two samples differing in age and health status, between-person variance accounted for approximately half of the total variation in PSS scores over time. While within-person variance was observed, the construct assessed by the PSS may substantially reflect a more stable characteristic of how an individual perceives stressful life circumstances than previously appreciated.

The Perceived Stress Scale (PSS) is a widely used questionnaire designed to assess how an individual perceives recent stress in their life. It is unclear, however, the degree to which the PSS is measuring factors that are consistent within individuals versus those that fluctuate, and how these components might change when the PSS is administered repeatedly over time. To address this knowledge gap, data from two studies were used­a study of 137 patients with heart failure followed for 39 months and a study of 73 younger, healthy adults followed for 12 months. In each, participants completed up to 13 PSS assessments, with 2,880 total PSS assessments completed across the studies. Multilevel linear mixed modeling was used to examine sources of score variance across assessments. Between-person variance (i.e., score variability that is relatively stable over time but differs between individuals) accounted for approximately half of the total variation in PSS scores over time, and was higher over shorter assessment periods. While within-person variance was observed (i.e., score variability that fluctuates within the same individual over time), these results suggest that the PSS may assess a substantially more stable characteristic of how an individual perceives stressful life circumstances than previously appreciated.

Advance directive screening among veterans with incident heart failure: Comparisons among people aging with and without HIV.

BACKGROUND: Heart failure (HF) is common among people aging with HIV (PWH) and without HIV (PWoH). Despite the poor prognosis for HF, advance directives (AD) completion is low but has not been compared among PWH and PWoH. OBJECTIVES: Determine the prevalence and predictors of AD screening among PWH and PWoH with incident HF. METHODS: We included Veterans with an incident HF diagnosis code from 2013-2018 in the Veterans Aging Cohort Study (VACS) without prior AD screening. Health records were reviewed for AD screening note titles within -30 days to 1-year post-HF diagnosis. Analyses were stratified by HIV status. Trends in annual AD screening were evaluated with the Cochran-Mantel-Haenszel test. The associations of AD screening with demographics, disease severity (Charlson Comorbidity Index, VACS 2.0 Index), and healthcare encounters (cardiology, palliative care, hospitalization) were evaluated with Cox proportional hazards regression. RESULTS: HF was diagnosed in 4516 Veterans (28.2% PWH, 71.8% PWoH). Annual AD screening rates increased in both groups (Ptrend<0.0001) and aggregate rates were higher among PWH than PWoH (53.5% vs. 48.2%, p=.001). In both groups, the likelihood of AD screening increased with greater disease severity, palliative care contact, and hospitalization (HR range=1.04-3.32, all p≤.02) but not with cardiology contact (p≥.53). CONCLUSIONS: AD screening rates after incident HF remain suboptimal but increased over time and were higher in PWH. Future quality improvement and implementation efforts should aim for universal AD screening with incident HF diagnosis, initiated by providers skilled in discussing AD, including in the cardiology subspecialty setting.

Integrated care for older multimorbid heart failure patients: protocol for the ESCAPE randomized trial and cohort study.

ESCAPE: Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multimorbid elderly patients. THERAPEUTIC AREA: Healthcare interventions for the management of older patients with multiple morbidities. AIMS: Multi-morbidity treatment is an increasing challenge for healthcare systems in ageing societies. This comprehensive cohort study with embedded randomized controlled trial tests an integrated biopsychosocial care model for multimorbid elderly patients. HYPOTHESIS: A holistic, patient-centred pro-active 9-month intervention based on the blended collaborative care (BCC) approach and enhanced by information and communication technologies can improve health-related quality of life (HRQoL) and disease outcomes as compared with usual care at 9 months. METHODS: Across six European countries, ESCAPE is recruiting patients with heart failure, mental distress/disorder plus ≥2 medical co-morbidities into an observational cohort study. Within the cohort study, 300 patients will be included in a randomized controlled assessor-blinded two-arm parallel group interventional clinical trial (RCT). In the intervention, trained care managers (CMs) regularly support patients and informal carers in managing their multiple health problems. Supervised by a clinical specialist team, CMs remotely support patients in implementing the treatment plan-customized to the patients' individual needs and preferences-into their daily lives and liaise with patients' healthcare providers. An eHealth platform with an integrated patient registry guides the intervention and helps to empower patients and informal carers. HRQoL measured with the EQ-5D-5L as primary endpoint, and secondary outcomes, that is, medical and patient-reported outcomes, healthcare costs, cost-effectiveness, and informal carer burden, will be assessed at 9 and ≥18 months. CONCLUSIONS: If proven effective, the ESCAPE BCC intervention can be implemented in routine care for older patients with multiple morbidities across the participating countries and beyond.

Association of depression and anxiety disorders with outcomes after revascularization in chronic limb-threatening ischemia hospitalizations nationwide.

OBJECTIVE: Patients with chronic limb-threatening ischemia (CLTI), the end stage of peripheral artery disease, often present with comorbid depression and anxiety disorders. The prevalence of these comorbidities in the inpatient context over time, and their association with outcomes after revascularization and resource usage is unknown. METHODS: Using the 2011 to 2017 National Inpatient Sample, two cohorts were created-CLTI hospitalizations with endovascular revascularization and CLTI hospitalizations with surgical revascularization. Within each cohort, the annual prevalence of depression and anxiety disorder diagnoses was determined, and temporal trends were evaluated using the Cochran-Mantel-Haenszel test. Hierarchical multivariable logistic and linear regression analyses were used to examine the association of depression and anxiety disorder diagnoses with inpatient major amputation, mortality, length of stay (LOS), and cost, adjusting for illness severity, comorbidities, and potential bias in the documentation of depression and anxiety disorder diagnoses stratified by patient sociodemographic data. RESULTS: Across the study period were a total of 245,507 CLTI-related hospitalizations with endovascular revascularization and 138,922 with surgical revascularization. Hospitalizations with a depression or anxiety disorder diagnosis increased from 10.8% in 2011 to 15.3% in 2017 in the endovascular revascularization cohort and from 11.7% in 2011 to 14.4% in 2017 in the surgical revascularization cohort (Ptrend < .001). In the endovascular revascularization cohort, depression was associated with higher odds of major amputation (odds ratio, 1.15; 95% confidence interval, 1.03-1.30). In addition, depression (9 vs 8 days [P < .001]; $105,754 vs $102,481 [P = .018]) and anxiety disorder (9 vs 8 days [P < .001]; $109,496 vs $102,324 [P < .001]) diagnoses were associated with a longer median LOS and higher median costs. In the surgical revascularization cohort, depression was associated with a higher odds of major amputation (odds ratio, 1.33; 95% confidence interval, 1.13-1.58) and a longer LOS (median, 9 vs 9 days; P = .004). CONCLUSIONS: Depression and anxiety disorder diagnoses have become increasingly prevalent among CLTI hospitalizations including revascularizations. When present, these psychiatric comorbidities are associated with an increased risk of amputation and greater resource usage.

The association of depression with mortality and major adverse limb event outcomes in patients with peripheral artery disease: A systematic review and meta-analysis.

BACKGROUND: Peripheral artery disease (PAD) is highly prevalent and associated with poor outcomes. Depression is a risk factor for adverse outcomes in patients with coronary artery disease. Despite evidence showing that depression is common in patients with PAD, less is known about its association with adverse prognostic outcomes. To address this, we conducted a systematic review and meta-analysis to summarize the association between depression and outcomes in patients with PAD. METHODS: We performed a systematic search of eight databases to January 2022 including studies that reported a risk estimate for the association of depression or depressive symptoms with all-cause mortality or major adverse limb events (MALE) in patients with PAD and pooled results in a meta-analysis. Risk of bias was assessed using ROBINS-I. RESULTS: Of the 7048 articles screened, 5 observational studies with 119,123 patients were included. A total of 16.2 % had depression or depressive symptoms. Depression was associated with a statistically significant increased risk of all-cause mortality (HR 1.24, confidence interval 1.07-1.25, p = .005). The association between depression and MALE was not significant but trended toward a positive association. LIMITATIONS: Due to lack of data, results were limited by a single study with a large sample size, overrepresentation of men, and lack of information of depression severity or treatment status. CONCLUSION: Depression or depressive symptoms are associated with a 24 % increased risk of all-cause mortality in patients with PAD. Future work should explore the mechanisms and directionality of this association and identify depression as an important comorbidity to address for patients with PAD. REGISTRATION: PROSPERO CRD 42021223694.

Post-9/11 deployment history and the incidence of breast cancer among women veterans.

PURPOSE: To determine if women Veterans who deployed in support of Operations Enduring Freedom/Iraqi Freedom (OEF/OIF) would show a greater likelihood of breast cancer (BC) than other women Veterans. METHODS: This was a retrospective cohort study of women aged <60 years who received Veterans Affairs medical center primary care, 2001-2021. The exposure was OEF/OIF deployment and the outcome was a BC diagnosis after entering Veterans Affairs care. Poisson models evaluated the association between deployment and BC incidence, covarying demographics, lifestyle factors, and hormonal contraceptive and hormone replacement therapy use. Analyses were also stratified by age and race, and a sensitivity analysis adjusted for healthcare utilization over the initial 2 years. RESULTS: Of 576,601 women, 24.6% (n = 141,935) deployed during post-9/11 conflicts. Across follow-up [median: 8.2 years], 1.2% women were diagnosed with BC. Those who deployed in support of OEF/OIF were 23% less likely to be diagnosed with BC than women who did not deploy (95% CI: 0.73, 0.86). The association remained in stratified models and when including healthcare utilization. CONCLUSIONS: Despite the exposures of OEF/OIF deployment, there was a significantly lower incidence of BC among women who deployed versus not, possibly due to a healthy soldier effect or to differences in screening.

Anhedonic Depression Is Not Associated With Risk of Recurrent Major Adverse Cardiac Events and All-Cause Mortality in Acute Coronary Syndrome Patients.

BACKGROUND: Depression after acute coronary syndrome (ACS) is common and increases risks of adverse outcomes, but it remains unclear which depression features are most associated with major adverse cardiac events (MACE) and all-cause mortality (ACM). PURPOSE: To examine whether a subtype of depression characterized by anhedonia and major depressive disorder (MDD) predicts 1-year MACE/ACM occurrence in ACS patients compared to no MDD history. We also consider other depression features in the literature as predictors. METHODS: Patients (N = 1,087) presenting to a hospital with ACS completed a self-report measure of current depressive symptoms in-hospital and a diagnostic interview assessing MDD within 1 week post-hospitalization. MACE/ACM events were assessed at 1-, 6-, and 12-month follow-ups. Cox regression models were used to examine the association of the anhedonic depression subtype and MDD without anhedonia with time to MACE/ACM, adjusting for sociodemographic and clinical covariates. RESULTS: There were 142 MACE/ACM events over the 12-month follow-up. The 1-year MACE/ACM in patients with anhedonic depression, compared to those with no MDD, was somewhat higher in an age-adjusted model (hazard ratio [HR] = 1.63, p = .08), but was not significant after further covariate adjustment (HR = 1.24, p = .47). Of the additional depression features, moderate-to-severe self-reported depressive symptoms significantly predicted the risk of MACE/ACM, even in covariate-adjusted models (HR = 1.72, p = .04), but the continuous measure of self-reported depressive symptoms did not. CONCLUSION: The anhedonic depression subtype did not uniquely predict MACE/ACM as hypothesized. Moderate-to-severe levels of total self-reported depressive symptoms, however, may be associated with increased MACE/ACM risk, even after accounting for potential sociodemographic and clinical confounders.