Medication cost-reducing behaviors in older adults with atrial fibrillation: The SAGE-AF study.

BACKGROUND: As patient prices for many medications have risen steeply in the United States, patients may engage in cost-reducing behaviors (CRBs) such as asking for generic medications or purchasing medication from the Internet. OBJECTIVE: The objective of this study is to describe patterns of CRB, cost-related medication nonadherence, and spending less on basic needs to afford medications among older adults with atrial fibrillation (AF) and examine participant characteristics associated with CRB. METHODS: Data were from a prospective cohort study of older adults at least 65 years with AF and a high stroke risk (CHA2DS2VASc ≥ 2). CRB, cost-related medication nonadherence, and spending less on basic needs to afford medications were evaluated using validated measures. Chi-square and t tests were used to evaluate differences in characteristics across CRB, and statistically significant characteristics (P < 0.05) were entered into a multivariable logistic regression to examine factors associated with CRB. RESULTS: Among participants (N = 1224; mean age 76 years; 49% female), 69% reported engaging in CRB, 4% reported cost-related medication nonadherence, and 6% reported spending less on basic needs. Participants who were cognitively impaired (adjusted odds ratio 0.69 [95% CI 0.52-0.91]) and those who did not identify as non-Hispanic white (0.66 [0.46-0.95]) were less likely to engage in CRB. Participants who were married (1.88 [1.30-2.72]), had a household income of $20,000-$49,999 (1.52 [1.02-2.27]), had Medicare insurance (1.38 [1.04-1.83]), and had 4-6 comorbidities (1.43 [1.01-2.01]) had significantly higher odds of engaging in CRB. CONCLUSION: Although CRBs were common among older adults with AF, few reported cost-related medication nonadherence and spending less on basic needs. Patients with cognitive impairment may benefit from pharmacist intervention to provide support in CRB and patient assistance programs.

Presence of Geriatric Conditions Is Prognostic of Major Bleeding in Older Patients with Atrial Fibrillation: a Cohort Study.

BACKGROUND: In older patients with atrial fibrillation (AF), physical, cognitive, and psychosocial limitations are prevalent. The prognostic value of these conditions for major bleeding is unclear. OBJECTIVE: To determine whether geriatric conditions are prospectively associated with major bleeding in older patients with AF on anticoagulation. DESIGN: Multicenter cohort study with 2-year follow-up from 2016 to 2020 in Massachusetts and Georgia from cardiology, electrophysiology, and primary care clinics. PARTICIPANTS: Diagnosed with AF, age 65 years or older, CHA2DS2-VASc score of 2 or higher, and taking oral anticoagulant (n=1,064). A total of 6507 individuals were screened. MAIN MEASURES: A six-component geriatric assessment of frailty, cognitive function, social support, depressive symptoms, vision, and hearing. Main outcome was major bleeding adjudicated by a physician panel. KEY RESULTS: At baseline, participants were, on average, 75.5 years old and 49% were women. Mean CHA2DS2-VASc score was 4.5 and the mean HAS-BLED score was 3.3. During 2.0 (± 0.4) years of follow-up, 95 (8.9%) participants developed an episode of major bleeding. After adjusting for key covariates and accounting for competing risk from death, cognitive impairment (hazard ratio [HR] 1.62, 95% confidence interval [CI]: 1.02-2.56) and frailty (HR 2.77, 95% CI 1.38-5.58) were significantly associated with the development of major bleeding. CONCLUSIONS: In older patients with AF taking anticoagulants, cognitive impairment and frailty were independently associated with major bleeding.

School-supervised Asthma Therapy is Associated with Improved Long-Term Asthma Outcomes for Underrepresented Minority Children.

Asthma morbidity disproportionately impacts children from low-income and racial/ethnic minority communities. School-supervised asthma therapy improves asthma outcomes for up to 15 months for underrepresented minority children, but little is known about whether these benefits are sustained over time. We examined the frequency of emergency department (ED) visits and hospital admissions for 83 children enrolled in Asthma Link, a school nurse-supervised asthma therapy program serving predominantly underrepresented minority children. We compared outcomes between the year preceding enrollment and years one-four post-enrollment. Compared with the year prior to enrollment, asthma-related ED visits decreased by 67.9% at one year, 59.5% at two years, 70.2% at three years, and 50% at four years post-enrollment (all p-values< 0.005). There were also significant declines in mean numbers of total ED visits, asthma-related hospital admissions, and total hospital admissions. Our results indicate that school nurse-supervised asthma therapy could potentially mitigate racial/ethnic and socioeconomic inequities in childhood asthma.

Non-specific pain and 30-day readmission in acute coronary syndromes: findings from the TRACE-CORE prospective cohort.

BACKGROUND: Patients with acute coronary syndromes often experience non-specific (generic) pain after hospital discharge. However, evidence about the association between post-discharge non-specific pain and rehospitalization remains limited. METHODS: We analyzed data from the Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE) prospective cohort. TRACE-CORE followed patients with acute coronary syndromes for 24 months post-discharge from the index hospitalization, collected patient-reported generic pain (using SF-36) and chest pain (using the Seattle Angina Questionnaire) and rehospitalization events. We assessed the association between generic pain and 30-day rehospitalization using multivariable logistic regression (N = 787). We also examined the associations among patient-reported pain, pain documentation identified by natural language processing (NLP) from electronic health record (EHR) notes, and the outcome. RESULTS: Patients were 62 years old (SD = 11.4), with 5.1% Black or Hispanic individuals and 29.9% women. Within 30 days post-discharge, 87 (11.1%) patients were re-hospitalized. Patient-reported mild-to-moderate pain, without EHR documentation, was associated with 30-day rehospitalization (odds ratio [OR]: 2.03, 95% confidence interval [CI]: 1.14-3.62, reference: no pain) after adjusting for baseline characteristics; while patient-reported mild-to-moderate pain with EHR documentation (presumably addressed) was not (OR: 1.23, 95% CI: 0.52-2.90). Severe pain was also associated with 30-day rehospitalization (OR: 3.16, 95% CI: 1.32-7.54), even after further adjusting for chest pain (OR: 2.59, 95% CI: 1.06-6.35). CONCLUSIONS: Patient-reported post-discharge generic pain was positively associated with 30-day rehospitalization. Future studies should further disentangle the impact of cardiac and non-cardiac pain on rehospitalization and develop strategies to support the timely management of post-discharge pain by healthcare providers.

Physical, cognitive, and psychosocial conditions in relation to anticoagulation satisfaction among elderly adults with atrial fibrillation: The SAGE-AF study.

BACKGROUND: Successful anticoagulation is critical for stroke prevention in adults with atrial fibrillation (AF). Anticoagulation satisfaction is a key indicator of treatment success. While physical, cognitive, and psychosocial limitations are common in elderly AF patients, their associations with anticoagulation satisfaction are unknown. OBJECTIVE: Examine whether anticoagulation satisfaction differs among AF patients with and without physical, cognitive, and psychosocial conditions. METHODS: The study comprised AF patients greater than or equal to 65 years old who were prescribed an oral anticoagulant (warfarin 57%; direct oral anticoagulant [DOAC] 43%). Frailty, cognitive function, social support, depressive symptoms, vision, hearing, and anxiety were assessed using validated measures. Anticoagulation satisfaction was measured using the anticlot treatment scale. RESULTS: Participants (n = 1037, 50% female) were on average 76 years old. The following conditions were prevalent: frailty (14%), cognitive impairment (42%), social isolation (13%), vision impairment (35%), hearing impairment (36%), depression (29%), and anxiety (24%). Average anticlot treatment burden scale was 55 out of 60 (lower burden scales indicating higher perceived burden). Patients with high perceived burden were older, more likely to be female, and receive warfarin. After adjusting for confounders, visual impairment (adjusted odds ratio [95% confidence interval]: 1.7 [1.2-2.4]), depressive symptoms (2.4 [1.6-3.7]), and anxiety (1.8 [1.2-2.7]) were significantly associated with high perceived burden. Different conditions were associated with high perceived burden in warfarin vs DOAC users. CONCLUSION: Physical, cognitive, and psychosocial limitations are prevalent and associated with high perceived anticoagulation burden among elderly AF adults. These conditions merit consideration in anticoagulation prescribing.

Religious practices and changes in health-related quality of life after hospital discharge for an acute coronary syndrome.

BACKGROUND: Religious beliefs and practices influence coping mechanisms and quality of life in patients with various chronic illnesses. However, little is known about the influence of religious practices on changes in health-related quality of life (HRQOL) among hospital survivors of an acute coronary syndrome (ACS). The present study examined the association between several items assessing religiosity and clinically meaningful changes in HRQOL between 1 and 6 months after hospital discharge for an ACS. METHODS: We recruited patients hospitalized for an ACS at six medical centers in Central Massachusetts and Georgia (2011-2013). Participants reported making petition prayers for their health, awareness of intercessory prayers by others, and deriving strength/comfort from religion. Generic HRQOL was assessed with the SF-36®v2 physical and mental component summary scores. Disease-specific HRQOL was evaluated using the Seattle Angina Questionnaire Quality of Life subscale (SAQ-QOL). We separately examined the association between each measure of religiosity and the likelihood of experiencing clinically meaningful increase in disease-specific HRQOL (defined as increases by ≥10.0 points) and Generic HRQOL (defined as increases by ≥3.0 points) between 1- and 6-months post-hospital discharge. RESULTS: Participants (n = 1039) were, on average, 62 years old, 33% were women, and 86% were non-Hispanic White. Two-thirds reported praying for their health, 88% were aware of intercessions by others, and 85% derived strength/comfort from religion. Approximately 42, 40, and 26% of participants experienced clinically meaningful increases in their mental, physical, and disease-specific HRQOL respectively. After adjustment for sociodemographic, psychosocial, and clinical characteristics, petition (aOR:1.49; 95% CI: 1.09-2.04) and intercessory (aOR:1.72; 95% CI: 1.12-2.63) prayers for health were associated with clinically meaningful increases in disease-specific and physical HRQOL respectively. CONCLUSIONS: Most ACS survivors in a contemporary, multiracial cohort acknowledged praying for their health, were aware of intercessory prayers made for their health and derived strength and comfort from religion. Patients who prayed for their health and those aware of intercessions made for their health experienced improvement in their generic physical and disease-specific HRQOL over time. Healthcare providers should recognize that patients may use prayer as a coping strategy for improving their well-being and recovery after a life-threatening illness.

Barriers to Healthcare Access and Long-Term Survival After an Acute Coronary Syndrome.

BACKGROUND: Barriers to healthcare are common in the USA and may result in worse outcomes among hospital survivors of an acute coronary syndrome (ACS). OBJECTIVE: To examine the relationship between barriers to healthcare and 2-year mortality after hospital discharge for an ACS. DESIGN: Longitudinal study. SETTING: Survivors of an ACS hospitalization were recruited from 6 medical centers in central Massachusetts and Georgia in 2011-2013. PATIENTS: Study participants with a confirmed ACS reported whether they had a financial-related healthcare barrier, no usual source of care, or a transportation-related healthcare barrier around the time of hospital admission. INTERVENTIONS: None. MEASUREMENTS: Cox regression analyses calculated adjusted hazard ratios (aHRs) for 2-year all-cause mortality for the three healthcare barriers while controlling for several demographic, clinical, and psychosocial characteristics. RESULTS: The mean age of study participants (n = 2008) was 62 years, 33% were women, and 77% were non-Hispanic white. One third of patients reported a financial barrier, 17% lacked a usual source of care, and 12% had a transportation barrier. Five percent (n = 100) died within 2 years after hospital discharge. Compared to patients without these barriers, those lacking a usual source of care and with barriers to transportation experienced significantly higher mortality (aHRs 1.40, 95% CI 1.30 to 1.51 and 1.46, 95% CI 1.13 to 1.89, respectively). Financial barriers were not associated with all-cause mortality (aHR 0.79, 95% CI 0.60 to 1.06). LIMITATIONS: Observational study with other unmeasured potentially confounding prognostic factors. CONCLUSIONS: Absence of an established usual source of care and inconsistent transportation availability were associated with a higher risk for dying after an ACS. Patients with these barriers to follow-up care may benefit from more intensive follow-up and support.

School nurse asthma program reduces healthcare utilization in children with persistent asthma.

OBJECTIVE: We examined the impact of a novel, school nurse-supervised asthma therapy program on healthcare utilization. METHODS: We retrospectively reviewed charts of 84 children enrolled in this program in central Massachusetts between 2012 and 2015. Physicians identified children with persistent asthma and poor medication adherence. These children were enrolled in the program to receive daily-inhaled corticosteroid at school, supervised by their school nurse, with ongoing communication between physician's office and school nurse through the school year. This program relied on established family, provider and school resources rather than research staff. The primary outcome was change in the number of emergency department (ED) visits in the year before and after enrollment. Secondary outcomes were hospital admissions, school absences, and rescue medication use. RESULTS: The study population was on average 10.5 years old, 63% male, 67% Hispanic, 19% black, 14% white with 95% using Medicaid insurance. Asthma-related ED visits over a 1-year period decreased 37.5%, from a pre-intervention mean of 0.8 visits to a post-intervention mean of 0.3 visits (p < 0.001). Asthma-related hospital admissions decreased from a pre-intervention mean of 0.3 admissions to post-intervention mean of 0 admissions (p < 0.001). Asthma rescue medication refills decreased by 46.3% from the pre- to post-intervention period (p = <.001). There were also non-significant declines in school absences and oral steroid use for children enrolled. CONCLUSIONS: We demonstrate a significant reduction in healthcare utilization for children enrolled in this unique school nurse-supervised asthma program, which utilizes a clinical-school partnership to deliver preventative asthma medication to school-aged children under sustainable conditions.

Survivors of an Acute Coronary Syndrome With Lower Patient Activation Are More Likely to Experience Declines in Health-Related Quality of Life.

BACKGROUND: Patient activation comprises the knowledge, skills, and confidence for self-care and may lead to better health outcomes. OBJECTIVES: We examined the relationship between patient activation and changes in health-related quality of life (HRQOL) after hospitalization for an acute coronary syndrome (ACS). METHODS: We studied patients from 6 medical centers in central Massachusetts and Georgia who had been hospitalized for an ACS between 2011 and 2013. At 1 month after hospital discharge, the patients completed the 6-item Patient Activation Measure and were categorized into 4 levels of activation. Multinomial logistic regression analyses compared activation level with clinically meaningful changes (≥3.0 points, generic; ≥10.0 points, disease-specific) in generic physical (SF-36v2 Physical Component Summary [PCS]), generic mental (SF-36v2 Mental Component Summary [MCS]), and disease-specific (Seattle Angina Questionnaire [SAQ]) HRQOL from 1 to 3 and 1 to 6 months after hospitalization, adjusting for potential sociodemographic and clinical confounders. RESULTS: The patients (N = 1042) were, on average, 62 years old, 34% female, and 87% non-Hispanic white. A total of 10% were in the lowest level of activation. The patients with the lowest activation had 1.95 times (95% confidence interval, 1.05-3.62) and 2.18 times (95% confidence interval, 1.17-4.05) the odds of experiencing clinically significant declines in MCS and SAQ HRQOL, respectively, between 1 and 6 months than the most activated patients. The patient activation level was not associated with meaningful changes in PCS scores. CONCLUSIONS: Hospital survivors of an ACS with lower activation may be more likely to experience declines in mental and disease-specific HRQOL than more-activated patients, identifying a group at risk of poor outcomes.

Ventricular Tachycardia and Hospital Readmission in Patients Discharged From the Hospital After an Acute Myocardial Infarction.

Background: Although ventricular tachycardia (VT) occurring during hospitalization for an acute myocardial infarction (AMI) increases mortality risk, its relationship with 30-day postdischarge rehospitalization has not been examined. Methods: Using data from the Worcester Heart Attack Study, we examined the association between early (during the first 48 hours of admission) and late (after 48 hours from admission) VT with 30-day postdischarge all-cause and cardiovascular disease (CVD)-related rehospitalization while analytically controlling for several demographic and clinical factors. Results: The study population consisted of 3534 patients who were hospitalized with an AMI between 2005 and 2015 (average age, 67.2 years; 40.7% women); VT occurred in 452 patients (13.7%), with the majority of instances (81.2%) occurring within 48 hours of admission. The 30-day all-cause rehospitalization rate was 17.3%, with 70.9% of the hospitalizations related to CVD. The odds of rehospitalization were 1.63 times (95% confidence interval [CI] = 0.99-2.69) and 1.12 times (95% CI = 0.83-1.51) higher for patients with AMI who developed late VT and early VT, respectively, compared to patients who did not develop VT. The risk of rehospitalization among patients with late VT was higher (odds ratio = 2.22 (95% CI = 0.79-6.26) in those with ST-segment-elevation AMI, compared to those with non-ST-segment-elevation AMI (odds ratio = 1.45 (95% CI = 0.81-2.57); early VT was not associated with rehospitalization in patients with either AMI subtype. No significant association was present between the occurrence of VT and CVD-related rehospitalization. Conclusions: Patients who develop late VT may experience a higher risk of 30-day rehospitalization following hospital discharge for AMI, especially among those with ST-segment-elevation AMI. Larger studies are needed to confirm our findings.

Contexte: Bien qu'une tachycardie ventriculaire (TV) survenant pendant une hospitalisation pour un infarctus aigu du myocarde (IAM) augmente le risque de décès, son lien avec une réhospitalisation dans les 30 jours suivant le congé n'a pas fait l'objet d'étude. Méthodologie: À partir des données de l'étude Worcester Heart Attack Study, nous avons étudié le lien entre les TV précoces (dans les 48 heures de l'hospitalisation) et tardives (après 48 heures d'hospitalisation) et les réhospitalisations liées à une maladie cardiovasculaire et toutes causes confondues 30 jours après le congé, tout en tenant compte de manière analytique de plusieurs facteurs démographiques et cliniques. Résultats: La population de l'étude était composée de 3 534 patients qui ont été hospitalisés pour un IAM entre 2005 et 2015 (âge moyen, 67,2 ans; 40,7 % de femmes). Une TV est survenue chez 452 patients (13,7 %), la majorité des cas (81,2 %) dans les 48 heures de l'hospitalisation. Le taux de réhospitalisations toutes causes confondues à 30 jours était de 17,3 %, 70,9 % des cas étant liés à une maladie cardiovasculaire. Chez les patients ayant eu un IAM et ayant subi une TV tardive ou précoce, les risques de réhospitalisation étaient respectivement 1,63 fois (intervalle de confiance [IC] à 95 % = 0,99-2,69) et 1,12 fois (IC à 95 % = 0,83-1,51) plus élevés que chez ceux qui n'avaient pas développé de TV. Le risque de réhospitalisation chez les patients ayant subi une TV tardive était plus élevé (risque relatif approché = 2,22 [IC à 95 % = 0,79-6,26]) chez ceux ayant eu un IAM avec élévation du segment ST que chez ceux ayant eu un IAM sans élévation du segment ST (risque relatif approché = 1,45 [IC à 95 % = 0,81-2,57]). La TV précoce n'a pas été associée à la réhospitalisation chez les patients dans l'un ou l'autre des sous-types d'IAM. Aucun lien important n'a été observé entre la survenue d'une TV et la réhospitalisation pour une maladie cardiovasculaire. Conclusions: Chez les patients qui développent une TV tardive, le risque de réhospitalisation 30 jours après le congé de l'hôpital pour un IAM peut être augmenté, particulièrement lorsque l'IAM s'accompagne d'une élévation du segment ST. De vastes études sont nécessaires pour confirmer nos observations.

Cognitive impairment and treatment strategy for atrial fibrillation in older adults: The SAGE-AF study.

BACKGROUND: Cognitive impairment is strongly associated with atrial fibrillation (AF). Rate and rhythm control are the two treatment strategies for AF and the effect of treatment strategy on risk of cognitive decline and frailty is not well established. We sought to determine how treatment strategy affects geriatric-centered outcomes. METHODS: The Systematic Assessment of Geriatric Elements-AF (SAGE-AF) was a prospective, observational, cohort study. Older adults with AF were prospectively enrolled between 2016 and 2018 and followed longitudinally for 2 years. In a non-randomized fashion, participants were grouped by rate or rhythm control treatment strategy based on clinical treatment at enrollment. Baseline characteristics were compared. Longitudinal binary mixed models were used to compare treatment strategy with respect to change in cognitive function and frailty status. Cognitive function and frailty status were assessed with the Montreal Cognitive Assessment Battery and Fried frailty phenotype tools. RESULTS: 972 participants (mean age = 75, SD = 6.8; 49% female, 87% non-Hispanic white) completed baseline examination and 2-year follow-up. 408 (42%) were treated with rate control and 564 (58%) with rhythm control. The patient characteristics of the two groups were different at baseline. Participants in the rate control group were older, more likely to have persistent AF, prior stroke, be treated with warfarin and have baseline cognitive impairment. After adjusting for baseline differences, participants treated with rate control were 1.5 times more likely to be cognitively impaired over 2 years (adjusted OR: 1.47, 95% CI:1.12, 1.98) and had a greater decline in cognitive function (adjusted estimate: -0.59 (0.23), p < 0.01) in comparison to rhythm control. Frailty did not vary between the treatment strategies. CONCLUSIONS: Among those who had 2-year follow-up in non-randomized observational cohort, the decision to rate control AF in older adults was associated with increased odds of decline in cognitive function but not frailty.

Short and medium-term outcomes in individuals hospitalized with acute myocardial infarction and multiple chronic conditions: The Worcester heart attack study.

Background: Multiple chronic conditions (MCCs) are common in patients hospitalized with acute myocardial infarction (AMI). We examined the association of 12 MCCs with the risk of a 30-day hospital readmission and/or dying within one year among those discharged from the hospital after an AMI. We also examined the five most prevalent pairs of chronic conditions in this population and their association with the principal study endpoints. Methods: The study population consisted of 3,294 adults hospitalized with a confirmed AMI at the three major medical centers in central Massachusetts on an approximate biennial basis between 2005 and 2015. Patients were categorized as ≤1, 2-3, and ≥4 chronic conditions. Results: The median age of the study population was 67.9 years, 41.6% were women, and 15% had ≤1, 32% had 2-3, and 53% had ≥4 chronic conditions. Patients with ≥4 conditions tended to be older, had a longer hospital stay, and received fewer cardiac interventional procedures. There was an increased risk for being rehospitalized during the subsequent 30 days according to the presence of MCCs, with the highest risk for those with ≥4 conditions. There was an increased, but attenuated, risk for dying during the next year according to the presence of MCCs. Individuals with diabetes/hypertension and those with heart failure/chronic kidney disease were at particularly high risk for developing the principal study outcomes. Conclusion: Development of guidelines that include complex patients, particularly those with MCCs and those at high risk for adverse short/medium term outcomes, remain needed to inform best treatment practices.

Differential effect of anticoagulation according to cognitive function and frailty in older patients with atrial fibrillation.

BACKGROUND: In older patients with atrial fibrillation (AF), cognitive impairment and frailty are prevalent. It is unknown whether the risk and benefit of anticoagulation differ by cognitive function and frailty. METHODS: A total of 1244 individuals with AF with age ≥65 years and a CHADSVASC score ≥2 were recruited from clinics in Massachusetts and Georgia between 2016 and 18 and followed until 2020. At baseline, frailty status and cognitive function were assessed. Hazard ratios of anticoagulation on physician adjudicated outcomes were adjusted by the propensity for receiving anticoagulation and stratified by cognitive function and frailty status. RESULTS: The average age was 75.5 (± 7.1) years, 49% were women, and 86% were prescribed oral anticoagulants. At baseline, 528 (42.4%) participants were cognitively impaired and 172 (13.8%) were frail. The adjusted hazard ratios of anticoagulation for the composite of major bleeding or death were 2.23 (95% confidence interval: 1.08-4.61) among cognitively impaired individuals and 0.94 (95% confidence interval: 0.49-1.79) among cognitively intact individuals (P for interaction = 0.08). Adjusted hazard ratios for anticoagulation were 1.84 (95% confidence interval: 0.66-5.13) among frail individuals and 1.39 (95% confidence interval: 0.84-2.40) among not frail individuals (P for interaction = 0.67). CONCLUSION: Compared with no anticoagulation, anticoagulation is associated with more major bleeding episodes and death in older patients with AF who are cognitively impaired.

Anxiety, patient activation, and quality of life among stroke survivors prescribed smartwatches for atrial fibrillation monitoring.

Background: The detection of atrial fibrillation (AF) in stroke survivors is critical to decreasing the risk of recurrent stroke. Smartwatches have emerged as a convenient and accurate means of AF diagnosis; however, the impact on critical patient-reported outcomes, including anxiety, engagement, and quality of life, remains ill defined. Objectives: To examine the association between smartwatch prescription for AF detection and the patient-reported outcomes of anxiety, patient activation, and self-reported health. Methods: We used data from the Pulsewatch trial, a 2-phase randomized controlled trial that included participants aged 50 years or older with a history of ischemic stroke. Participants were randomized to use either a proprietary smartphone-smartwatch app for 30 days of AF monitoring or no cardiac rhythm monitoring. Validated surveys were deployed before and after the 30-day study period to assess anxiety, patient activation, and self-rated physical and mental health. Logistic regression and generalized estimation equations were used to examine the association between smartwatch prescription for AF monitoring and changes in the patient-reported outcomes. Results: A total of 110 participants (mean age 64 years, 41% female, 91% non-Hispanic White) were studied. Seventy percent of intervention participants were novice smartwatch users, as opposed to 84% of controls, and there was no significant difference in baseline rates of anxiety, activation, or self-rated health between the 2 groups. The incidence of new AF among smartwatch users was 6%. Participants who were prescribed smartwatches did not have a statistically significant change in anxiety, activation, or self-reported health as compared to those who were not prescribed smartwatches. The results held even after removing participants who received an AF alert on the watch. Conclusion: The prescription of smartwatches to stroke survivors for AF monitoring does not adversely affect key patient-reported outcomes. Further research is needed to better inform the successful deployment of smartwatches in clinical practice.

Is Catheter Ablation Associated with Preservation of Cognitive Function? An Analysis From the SAGE-AF Observational Cohort Study.

Objectives: To examine the associations between catheter ablation treatment (CA) versus medical management and cognitive impairment among older adults with atrial fibrillation (AF). Methods: Ambulatory patients who had AF, were ≥ 65-years-old, and were eligible to receive oral anticoagulation could be enrolled into the SAGE (Systematic Assessment of Geriatric Elements)-AF study from internal medicine and cardiology clinics in Massachusetts and Georgia between 2016 and 2018. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA) tool at baseline, one-, and two years. Cognitive impairment was defined as a MoCA score ≤ 23. Multivariate-adjusted logistic regression of longitudinal repeated measures was used to examine associations between treatment with CA vs. medical management and cognitive impairment. Results: 887 participants were included in this analysis. On average, participants were 75.2 ± 6.7 years old, 48.6% women, and 87.4% white non-Hispanic. 193 (21.8%) participants received a CA before enrollment. Participants who had previously undergone CA were significantly less likely to be cognitively impaired during the two-year study period (aOR 0.70, 95% CI 0.50-0.97) than those medically managed (i.e., rate and/or rhythm control), even after adjusting with propensity score for CA. At the two-year follow-up a significantly greater number of individuals in the non-CA group were cognitively impaired (MoCA ≤ 23) compared to the CA-group (311 [44.8%] vs. 58 [30.1%], p=0.0002). Conclusions: In this two-year longitudinal prospective cohort study participants who underwent CA for AF before enrollment were less likely to have cognitive impairment than those who had not undergone CA.

Is catheter ablation associated with preservation of cognitive function? An analysis from the SAGE-AF observational cohort study.

Objectives: To examine the associations between catheter ablation treatment (CA) vs. medical management and cognitive impairment among older adults with atrial fibrillation (AF). Methods: Ambulatory patients who had AF, were ≥65-years-old, and were eligible to receive oral anticoagulation could be enrolled into the SAGE (Systematic Assessment of Geriatric Elements)-AF study from internal medicine and cardiology clinics in Massachusetts and Georgia between 2016 and 2018. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA) tool at baseline, 1-, and 2 years. Cognitive impairment was defined as a MoCA score ≤ 23. Multivariate-adjusted logistic regression of longitudinal repeated measures was used to examine associations between treatment with CA vs. medical management and cognitive impairment. Results: 887 participants were included in this analysis. On average, participants were 75.2 ± 6.7 years old, 48.6% women, and 87.4% white non-Hispanic. 193 (21.8%) participants received a CA before enrollment. Participants who had previously undergone CA were significantly less likely to be cognitively impaired during the 2-year study period (aOR 0.70, 95% CI 0.50-0.97) than those medically managed (i.e., rate and/or rhythm control), even after adjusting with propensity score for CA. At the 2-year follow-up a significantly greater number of individuals in the non-CA group were cognitively impaired (MoCA ≤ 23) compared to the CA-group (311 [44.8%] vs. 58 [30.1%], p = 0.0002). Conclusion: In this 2-year longitudinal prospective cohort study participants who underwent CA for AF before enrollment were less likely to have cognitive impairment than those who had not undergone CA.

False Atrial Fibrillation Alerts from Smartwatches are Associated with Decreased Perceived Physical Well-being and Confidence in Chronic Symptoms Management.

Wrist-based wearables have been FDA approved for AF detection. However, the health behavior impact of false AF alerts from wearables on older patients at high risk for AF are not known. In this work, we analyzed data from the Pulsewatch (NCT03761394) study, which randomized patients (≥50 years) with history of stroke or transient ischemic attack to wear a patch monitor and a smartwatch linked to a smartphone running the Pulsewatch application vs to only the cardiac patch monitor over 14 days. At baseline and 14 days, participants completed validated instruments to assess for anxiety, patient activation, perceived mental and physical health, chronic symptom management self-efficacy, and medicine adherence. We employed linear regression to examine associations between false AF alerts with change in patient-reported outcomes. Receipt of false AF alerts was related to a dose-dependent decline in self-perceived physical health and levels of disease self-management. We developed a novel convolutional denoising autoencoder (CDA) to remove motion and noise artifacts in photoplethysmography (PPG) segments to optimize AF detection, which substantially reduced the number of false alerts. A promising approach to avoid negative impact of false alerts is to employ artificial intelligence driven algorithms to improve accuracy.

Accuracy, Usability, and Adherence of Smartwatches for Atrial Fibrillation Detection in Older Adults After Stroke: Randomized Controlled Trial.

BACKGROUND: Atrial fibrillation (AF) is a common cause of stroke, and timely diagnosis is critical for secondary prevention. Little is known about smartwatches for AF detection among stroke survivors. We aimed to examine accuracy, usability, and adherence to a smartwatch-based AF monitoring system designed by older stroke survivors and their caregivers. OBJECTIVE: This study aims to examine the feasibility of smartwatches for AF detection in older stroke survivors. METHODS: Pulsewatch is a randomized controlled trial (RCT) in which stroke survivors received either a smartwatch-smartphone dyad for AF detection (Pulsewatch system) plus an electrocardiogram patch or the patch alone for 14 days to assess the accuracy and usability of the system (phase 1). Participants were subsequently rerandomized to potentially 30 additional days of system use to examine adherence to watch wear (phase 2). Participants were aged 50 years or older, had survived an ischemic stroke, and had no major contraindications to oral anticoagulants. The accuracy for AF detection was determined by comparing it to cardiologist-overread electrocardiogram patch, and the usability was assessed with the System Usability Scale (SUS). Adherence was operationalized as daily watch wear time over the 30-day monitoring period. RESULTS: A total of 120 participants were enrolled (mean age 65 years; 50/120, 41% female; 106/120, 88% White). The Pulsewatch system demonstrated 92.9% (95% CI 85.3%-97.4%) accuracy for AF detection. Mean usability score was 65 out of 100, and on average, participants wore the watch for 21.2 (SD 8.3) of the 30 days. CONCLUSIONS: Our findings demonstrate that a smartwatch system designed by and for stroke survivors is a viable option for long-term arrhythmia detection among older adults at risk for AF, though it may benefit from strategies to enhance adherence to watch wear. TRIAL REGISTRATION: ClinicalTrials.gov NCT03761394; https://clinicaltrials.gov/study/NCT03761394. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.cvdhj.2021.07.002.

Technology engagement is associated with higher perceived physical well-being in stroke patients prescribed smartwatches for atrial fibrillation detection.

Background: Increasing ownership of smartphones among Americans provides an opportunity to use these technologies to manage medical conditions. We examine the influence of baseline smartwatch ownership on changes in self-reported anxiety, patient engagement, and health-related quality of life when prescribed smartwatch for AF detection. Method: We performed a post-hoc secondary analysis of the Pulsewatch study (NCT03761394), a clinical trial in which 120 participants were randomized to receive a smartwatch-smartphone app dyad and ECG patch monitor compared to an ECG patch monitor alone to establish the accuracy of the smartwatch-smartphone app dyad for detection of AF. At baseline, 14 days, and 44 days, participants completed the Generalized Anxiety Disorder-7 survey, the Health Survey SF-12, and the Consumer Health Activation Index. Mixed-effects linear regression models using repeated measures with anxiety, patient activation, physical and mental health status as outcomes were used to examine their association with smartwatch ownership at baseline. Results: Ninety-six participants, primarily White with high income and tertiary education, were randomized to receive a study smartwatch-smartphone dyad. Twenty-four (25%) participants previously owned a smartwatch. Compared to those who did not previously own a smartwatch, smartwatch owners reported significant greater increase in their self-reported physical health (ß = 5.07, P < 0.05), no differences in anxiety (ß = 0.92, P = 0.33), mental health (ß = -2.42, P = 0.16), or patient activation (ß = 1.86, P = 0.54). Conclusions: Participants who own a smartwatch at baseline reported a greater positive change in self-reported physical health, but not in anxiety, patient activation, or self-reported mental health over the study period.

Isolated calf deep vein thrombosis in the community setting: the Worcester Venous Thromboembolism study.

The prevalence of isolated calf deep vein thrombosis (DVT) in the community setting is relatively unexplored. Confusion remains with regards to its management and contemporary natural history. The purpose of this investigation was to describe the number of cases of calf DVT in the community, use of early management strategies, and rates of venous thromboembolism (VTE) recurrence and major bleeding. The medical records of residents of the Worcester (MA) metropolitan area with ICD-9 codes consistent with potential VTE during 4 study years (1999/2001/2003/2005) were validated by trained nurses. Patient demographic/clinical characteristics, treatment practices, and outcomes were evaluated. Isolated calf DVT was diagnosed in 166 (11.1%) of 1,495 patients with lower extremity DVT. Patients with calf DVT were less likely to be discharged on anticoagulants or with an IVC filter than patients with proximal DVT (84.1 vs. 92.3%). The rates of VTE recurrence and pulmonary embolism did not differ significantly between patients with calf DVT and proximal DVT at 6 months (11.0 vs. 8.7%, 2.6 vs. 1.8%, respectively). Patients with calf DVT had higher adjusted risk of early (14-day) VTE recurrence/extension (OR 2.34, 95% CI 1.01-5.44). Patients with calf DVT had lower rates of major bleeding at 6 months compared to patients with proximal DVT (5.2 vs. 9.3%, P = 0.04). Rates of recurrent VTE and major bleeding following calf DVT in the community are much higher than in randomized clinical trials of patients with proximal or calf DVT. Further study of management strategies for isolated calf DVT is needed.