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Single-lead electrocardiograms (1L ECGs) are increasingly used for atrial fibrillation (AF) detection. Automated 1L ECG interpretation may have prognostic value for future AF in cases in which screening does not result in a short-term AF diagnosis. We sought to investigate the association between automated 1L ECG interpretation and incident AF. VITAL-AF was a randomized controlled trial investigating the effectiveness of screening for AF by 1L ECGs. For this study, participants were divided into 4 groups based on automated classification of 1L ECGs. Patients with prevalent AF were excluded. Associations between groups and incident AF were assessed by Cox proportional hazards models adjusted for risk factors. The start of follow-up was defined as 60 days after the latest 1L ECG (as some individuals had numerous screening 1L ECGs). The study sample included never screened (n = 16,306), normal (n = 10,914), other (n = 2675), and possible AF (n = 561). Possible AF had the highest AF incidence (5.91 per 100 person-years; 95% confidence interval [CI], 4.24–8.23). Possible AF was associated with greater hazard of incident AF compared with normal (adjusted hazard ratio, 2.48; 95% CI, 1.66–3.71). Other was associated with greater hazard of incident AF compared with normal (1.41; 95% CI, 1.04–1.90). In patients undergoing AF screening with 1L ECGs without prevalent AF or AF within 60 days of screening, presumptive positive and indeterminate 1L ECG interpretations were associated with future AF. Abnormal 1L ECG recordings may identify individuals at higher risk for future AF. [ABSTRACT FROM AUTHOR]

Screening for atrial fibrillation (AF) using consumer-based devices capable of producing a single lead electrocardiogram (1L ECG) is increasing. There are limited data on the accuracy of physician interpretation of these tracings. The goal of this study is to assess the sensitivity, specificity, confidence, and variability of cardiologist interpretation of point-of-care 1L ECGs. Fifteen cardiologists reviewed point-of-care handheld 1L ECGs collected from patients aged 65 years or older enrolled in the VITAL-AF clinical trial [NCT035115057] who underwent cardiac rhythm assessments with a 1L ECG using an AliveCor KardiaMobile device. Random sampling of 1L ECGs for cardiologist review was stratified by the AliveCor algorithm interpretation. A 12L ECG performed on the same day for clinical purposes was used as the gold standard. Cardiologists each reviewed a common sample of 200 1L ECG tracings and completed a survey associated with each tracing. Cardiologists were blinded to both the AliveCor algorithm and same day 12L ECG interpretation. For each tracing, study cardiologists were asked to assess the rhythm (sinus rhythm, AF, unclassifiable), report their assessment of the quality of the tracing, and rate their confidence in rhythm interpretation. The outcomes included the sensitivity, specificity, variability, and confidence in physician interpretation. Variables associated with each measure were identified using multivariable regression. The average sensitivity for AF was 77.4% (range 50%-90.6%, standard deviation [SD]=11.4%) and the average specificity was 73.0% (range 41.3%-94.6%, SD = 15.4%). The mean variability was 30.8% (range 0%-76.2%, SD = 23.2%). The average reviewer confidence of 1L ECG rhythm assessment was 3.6 out of 5 (range 2.5-4.2, SD = 0.6). Patient and tracing factors associated with sensitivity, specificity, variability, and confidence were identified and included age, body mass index, and presence of artifact. Cardiologist interpretation of point-of-care handheld 1L ECGs has modest diagnostic sensitivity and specificity with substantial variability for AF classification despite high confidence. Variability in cardiologist interpretation of 1L ECGs highlights the importance of confirmatory testing for diagnosing AF. [Display omitted] [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

There are many challenges in the current landscape of electrophysiology (EP) clinical and translational research, including increasing costs and complexity, competing demands, regulatory requirements, and challenges with study implementation. This review seeks to broadly discuss the state of EP research, including challenges and opportunities. Included here are results from a Heart Rhythm Society (HRS) Research Committee member survey detailing HRS members' perspectives regarding both barriers to clinical and translational research and opportunities to address these challenges. We also provide stakeholder perspectives on barriers and opportunities for future EP research, including input from representatives of the U.S. Food and Drug Administration , industry, and research funding institutions that participated in a Research Collaboratory Summit convened by HRS. This review further summarizes the experiences of the heart failure and heart valve communities and how they have approached similar challenges in their own fields. We then explore potential solutions, including various models of research ecosystems designed to identify research challenges and to coordinate ways to address them in a collaborative fashion in order to optimize innovation, increase efficiency of evidence generation, and advance the development of new therapeutic products. The objectives of the proposed collaborative cardiac EP research community are to encourage and support scientific discourse, research efficiency, and evidence generation by exploring collaborative and equitable solutions in which stakeholders within the EP community can interact to address knowledge gaps, innovate, and advance new therapies. [ABSTRACT FROM AUTHOR]

Background: Screening for atrial fibrillation (AF) is attractive because AF independently raises the risk of ischemic stroke, this risk is largely reversible by long-term oral anticoagulant therapy (OAC), and many patients with AF remain undiagnosed and untreated. Recent trials of one-time brief screening for AF have not produced a significant increase in the proportion of patients diagnosed with AF. Trials of longer-term screening have demonstrated an increase in AF diagnoses, primarily paroxysmal AF. To date, however, no trials have demonstrated that screening for AF results in lower rates of stroke. Clinical practice guidelines conflict in their level of support for screening for AF.Methods: The GUARD-AF individually randomized trial is designed to test whether screening for AF in individuals age 70 years or greater using a 2-week single-lead electrocardiographic patch monitor can identify patients with undiagnosed AF and lead to treatment with OAC, resulting in a reduced rate of stroke in the screened population. The trial's efficacy end point is hospitalization for stroke (either ischemic or hemorrhagic) and the trial's safety end point is hospitalization for a bleeding event. End points will be ascertained via Medicare claims or electronic health records at 2.5 years after study start. Enrollment is based in primary care practices and the OAC decision for screen-detected cases is left to the patient and their physician. The initial planned target sample size was 52,000, with 26,000 allocated to either screening or to usual care.Results: Trial enrollment was severely hampered by the novel coronavirus disease 2019 (COVID-19) pandemic and stopped at a total enrollment of 11,931 participants. Of 5,965 randomized to the screening arm, 5,713 patients (96%) returned monitors with analyzable results. Incidence of screen-detected and clinically detected AF and associated stroke and bleeding outcomes will be ascertained.Conclusions: GUARD-AF is the largest AF screening randomized trial using a longer-term patch-based continuous electrocardiographic monitor. The results will contribute important information on the yield of patch-based AF screening, the "burden" of AF detected (percent time in AF, longest episode), and physicians' OAC decisions as a function of AF burden. GUARD-AF's stroke and bleed results will contribute to pooled trial analyses of AF screening, thereby informing future studies and guidelines. [ABSTRACT FROM AUTHOR]

Background: Early detection of atrial fibrillation or flutter (AF) may enable prevention of downstream morbidity. Consumer wrist-worn wearable technology is capable of detecting AF by identifying irregular pulse waveforms using photoplethysmography (PPG). The validity of PPG-based software algorithms for AF detection requires prospective assessment.Methods: The Fitbit Heart Study (NCT04380415) is a single-arm remote clinical trial examining the validity of a novel PPG-based software algorithm for detecting AF. The proprietary Fitbit algorithm examines pulse waveform intervals during analyzable periods in which participants are sufficiently stationary. Fitbit consumers with compatible wrist-worn trackers or smartwatches were invited to participate. Enrollment began May 6, 2020 and as of October 1, 2020, 455,699 participants enrolled. Participants in whom an irregular heart rhythm was detected were invited to attend a telehealth visit and eligible participants were then mailed a one-week single lead electrocardiographic (ECG) patch monitor. The primary study objective is to assess the positive predictive value of an irregular heart rhythm detection for AF during the ECG patch monitor period. Additional objectives will examine the validity of irregular pulse tachograms during subsequent heart rhythm detections, self-reported AF diagnoses and treatments, and relations between irregular heart rhythm detections and AF episode duration and time spent in AF.Conclusions: The Fitbit Heart Study is a large-scale remote clinical trial comprising a unique software algorithm for detection of AF. The study results will provide critical insights into the use of consumer wearable technology for AF detection, and for characterizing the nature of AF episodes detected using consumer-based PPG technology. [ABSTRACT FROM AUTHOR]

Given the preventable morbidity and mortality associated with atrial fibrillation (AF), increased awareness of undiagnosed AF, and advances in mobile electrocardiogram (ECG) technology, there is a critical need to assess the effectiveness of using such technology to routinely screen for AF in clinical practice. VITAL-AF is a pragmatic trial that will test whether screening for AF using a single-lead handheld ECG in individuals 65 years or older during primary care visits will lead to an increased rate of AF detection. The study is a cluster-randomized trial, with 8 primary care practices randomized to AF screening and 8 primary care practices randomized to usual care. We anticipate studying approximately 16,000 patients in each arm. During the 1-year enrollment period, practice medical assistants will screen eligible patients who agree to participate during office visits using a single-lead ECG device. Automated screening results are documented in the electronic health record, and patients can discuss screening results with their provider during the scheduled visit. All single-lead ECGs are overread by a cardiologist. Screen-detected AF is managed at the discretion of the patient's physician. The primary study end point is incident AF during the screening period. Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start. Outcomes are ascertained based on electronic health record documentation and are manually adjudicated. The results of this pragmatic trial may help identify a model for widespread adoption of AF screening as part of routine clinical practice. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) is a risk factor for atrial fibrillation (AF), stroke, and post-stroke disability. However, differing definitions and application of HF-criteria may impact model prediction. We compared the predictive ability of left ventricular ejection fraction (LVEF), a readily available objective echocardiographic index, with clinical HF definitions for functional disability and AF in stroke patients.Methods: We retrospectively analyzed ischemic stroke patients evaluated between January 2013 and May 2015. Outcomes of interest were: (a) 90-day functional disability (modified Rankin score 3-6) and (b) AF. We compared: (1) LVEF (continuous variable), (2) left ventricular systolic dysfunction (LVSD)-categories (absent to severe), (3) clinical history of HF, and (4) HF/LVSD-categories: (i) HF absent without LVSD, (ii) HF absent with LVSD, (iii) HF with preserved ejection fraction (HFpEF), and (iv) HF with reduced ejection fraction (HFrEF). Multivariable logistic regression was used to determine the predictive ability for 90-day disability and AF, respectively.Results: Six hundred eighty five consecutive patients (44.5% female) fulfilled the study criteria and were included. After adjustment, the LVEF was independently associated with 90-day disability (OR .98, 95% CI .96-.99, P = .011) with similar predictive ability (area under the curve [AUC] = .85) to models including the LVSD-categories (AUC = .85), clinically define HF (AUC = .86), and HF/LVSD-categories (AUC = .86). The LVEF, HF, LVSD-, and HF/LVSD-categories were independently associated with AF (P < .01, each) with similar predictive ability (AUC = .74, .74, .73, and .75, respectively).Conclusions: Compared to commonly defined HF definitions, the objectively determined LVEF possesses comparable predictive ability for 90-day disability and AF in stroke patients. [ABSTRACT FROM AUTHOR]

Abstract Background Healthcare providers play a critical role in the care transitions. Therefore, efforts to improve this process should be informed by their perspectives. Aim The study objective was to explore the factors that negatively/positively influence care transitions following an unplanned hospitalization from the perspective of healthcare providers. Methods A qualitative study using semi-structured interviews conducted between February and September of 2016 at a single academic medical center. We enrolled fifteen healthcare providers from multiple disciplines involved in the management of patients experiencing an unplanned hospitalization. Respondents shared their experiences with care transitions and identified factors within and outside of the discharging health facility that impede or facilitate this process. Transcribed interviews were analyzed using emerging themes from the interviews. Results We identified six themes and associated subthemes from the interviews on factors that influence care transitions. Three themes focused on factors within the discharging healthcare facility: untailored and overloaded patient discharge information, timing of the post-discharge care conversation, provider-to-patient and provider-to-provider miscommunication. The other three themes were related to external factors including caregiver involvement, having a safe and stable housing environment, and access to healthcare and community resources. Providers discussed how these factors positively/negatively influence the hospital-to-home transition. Conclusions Our study identifies factors within and outside the discharging healthcare facility that influence care transitions, ultimately affect patient-centered outcomes and provider satisfaction with delivered care. Strategies aimed at improving the quality of care transitions should address these barriers and actively engage healthcare providers who are pivotal in care transitions. Highlights • Facilitators and barriers to care transition exist in and out of healthcare system. • Clear and concise patient discharge information facilitates care transition. • Provider-provider and provider-patient miscommunication hinder transitions of care. • Caregiver involvement, safe housing, accessible resources promote care transition. • Providers should be actively engaged in interventions for effective transitions. [ABSTRACT FROM AUTHOR]

Background: There is a paucity of longitudinal research investigating the relations between atrial fibrillation (AF) and domain-specific cognitive performance.Objective: The purpose of this study was to investigate the association between AF and cognitive performance cross-sectionally and longitudinally.Methods: Eligible participants were dementia- and stroke-free at the time of baseline neuropsychological (NP) assessment and underwent at least 1 additional NP assessment with at least 1-year inter-test interval. AF status was examined as a 2-level variable (prevalent AF, no AF) in cross-sectional analyses and then separately as a 3-level variable (prevalent AF, interim AF, no AF) in longitudinal analyses. We examined the association between AF status and cognitive performance with linear regression. We first adjusted models for age and sex and then for vascular risk factors and apolipoprotein ε4 (APOE4) status.Results: We studied 2682 participants of the Framingham Heart Study original and offspring cohorts. At the baseline NP assessment, 112 participants (4%) had AF (mean age 72 ± 9 years; 32% women). After adjustment for vascular risk factors and APOE4 status, prevalent AF was significantly associated with poorer attention; sex differences were also noted with men performing worse on tests of abstract reasoning and executive function, while women did better on a measure of executive function. Prevalent AF was significantly associated with longitudinal decline in executive function in the original cohort, and interim AF was significantly associated with longitudinal decline in executive function in the offspring cohort.Conclusion: After accounting for vascular risk factor burden and APOE4 status, AF was associated with a vascular profile of change in cognitive function. [ABSTRACT FROM AUTHOR]