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Hypertension is among the most important risk factors for cardiovascular disease, chronic kidney disease, and dementia. The artificial intelligence (AI) field is advancing quickly, and there has been little discussion on how AI could be leveraged for improving the diagnosis and management of hypertension. AI technologies, including machine learning tools, could alter the way we diagnose and manage hypertension, with potential impacts for improving individual and population health. The development of successful AI tools in public health and health care systems requires diverse types of expertise with collaborative relationships between clinicians, engineers, and data scientists. Unbiased data sources, management, and analyses remain a foundational challenge. From a diagnostic standpoint, machine learning tools may improve the measurement of blood pressure and be useful in the prediction of incident hypertension. To advance the management of hypertension, machine learning tools may be useful to find personalized treatments for patients using analytics to predict response to antihypertension medications and the risk for hypertension-related complications. However, there are real-world implementation challenges to using AI tools in hypertension. Herein, we summarize key findings from a diverse group of stakeholders who participated in a workshop held by the National Heart, Lung, and Blood Institute in March 2023. Workshop participants presented information on communication gaps between clinical medicine, data science, and engineering in health care; novel approaches to estimating BP, hypertension risk, and BP control; and real-world implementation challenges and issues.

Background: There are no clinical trials with a head-to-head comparison between the 2 most commonly used oral anticoagulants (apixaban and rivaroxaban) in patients with atrial fibrillation (AF). The comparative efficacy and safety between these drugs remain unclear, especially in older patients who are at the highest risk for stroke and bleeding., Objective: The purpose of this study was to compare the risk of major bleeding and thromboembolic events between apixaban and rivaroxaban in older patients with AF., Methods: We conducted a population-based retrospective cohort study of all adult patients (66 years or older) with AF in Ontario, Canada, who were treated with apixaban or rivaroxaban between April 1, 2011, and March 31, 2020. The primary safety outcome was major bleeding, and the primary efficacy outcome was thromboembolic events. Secondary outcomes included any bleeding. Rates and hazard ratios (HRs) were adjusted for baseline comorbidities with inverse probability of treatment weighting., Results: This study included 42,617 patients with AF treated with apixaban and 30,725 patients treated with rivaroxaban. After inverse probability of treatment weighting using the propensity score, patients in the apixaban and rivaroxaban groups were well balanced for baseline values of demographic characteristics, comorbidities, and medications; both groups had a similar mean age of 77.4 years, and 49.9% were female. At 1 year, the apixaban group had a lower risk for both major bleeding with an absolute risk reduction at 1 year of 1.1% (2.1% vs 3.2%; HR 0.65; 95% confidence interval [CI] 0.59-0.71]) and any bleeding (8.1% vs 10.9%; HR 0.73; 95% CI 0.69-0.77), with no difference in the risk for thromboembolic events (2.2% vs 2.2%; HR 1.02; 95% CI 0.92-1.13)., Conclusion: In patients with AF, 66 years or older, treatment with apixaban was associated with lower risk for major bleeding, with no difference in the risk for thromboembolic events compared with rivaroxaban., Competing Interests: Disclosures Dr Shurrab is supported by a Research Chair in Cardiovascular Health, Health Sciences North Research Institute, Sudbury, Ontario. Dr Tu is supported by the Chair in Family and Community Medicine Research in Primary Care at UHN Department of Family and Community Medicine and receives a Research Scholar Award from the Department of Family and Community Medicine at the University of Toronto. Dr Turakhia has received research grants from Bristol Myers Squibb, American Heart Association, Bayer, Gilead Sciences, and the Food and Drug Administration and consulting fees from Medtronic, Pfizer, Johnson & Johnson, and AliveCor. He owns equity in iRhythm, Connect America, Forward, Evidently, and PocketRN. Dr Turakhia is an employee of iRhythm Technologies Inc., which manufactures ambulatory electrocardiogram monitors, but this work was not supported by the company and was performed exclusively in his academic role. Dr Lopes has received research grants or contracts from Amgen, Bristol Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, and Sanofi-Aventis as well as funding for educational activities or lectures from Pfizer, Bristol Myers Squibb, Novo Nordisk, and AstraZeneca and funding for consulting from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Novo Nordisk, and AstraZeneca. Dr Castellucci’s research institution has received honoraria from Bayer, Bristol Myers Squibb–Pfizer Alliance, the ACADEMY for Continued Advancement in Healthcare Education, Amag Pharmaceutical, LEO Pharma, Sanofi, Valeo Pharma, and Servier. Dr Ko is supported by the Jack Tu Chair in Cardiovascular Outcomes Research, Sunnybrook Hospital, and the University of Toronto. The remaining authors have nothing to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Objective data comparing the diagnostic performance of different ambulatory cardiac monitors (ACMs) are lacking., Objectives: To assess variation in monitoring strategy, clinical outcomes and healthcare utilization in patients undergoing ambulatory monitoring without a pre-existing arrhythmia diagnosis., Methods: Using the full sample (100%) of Medicare claims data, we performed a retrospective cohort study of diagnostic-naïve patients who received first-time ACM in 2017 to 2018 and evaluated arrhythmia encounter diagnosis at 3-months, repeat ACM testing at 6 months, all-cause 90-day emergency department (ED) and inpatient utilization, and cost of different strategies: Holter; long-term continuous monitor (LTCM); non-continuous, event-based external ambulatory event monitor (AEM); and mobile cardiac telemetry (MCT). We secondarily performed a device-specific analysis by manufacturer, identified from unique claim modifier codes., Results: ACMs were used in 287,789 patients (AEM = 10.3%; Holter = 53.8%; LTCM = 13.3%; MCT = 22.5%). Device-specific analysis showed that compared to Holter, AEM, MCT, or other LTCM manufacturers, a specific LTCM (Zio Ⓡ XT 14-day patch, iRhythm Technologies, San Francisco, CA) had the highest adjusted odds of diagnosis and lowest adjusted odds of ACM retesting. Findings were consistent for specific arrhythmia diagnoses of ventricular tachycardia, atrioventricular block, and paroxysmal atrial fibrillation. As a category, LTCM was associated with the lowest 1-year incremental health care expenditures (mean Δ$10,159), followed by Holter ($10,755), AEM ($11,462), and MCT ($12,532)., Conclusions: There was large variation in diagnostic monitoring strategy. A specific LTCM was associated with the highest adjusted odds of a new arrhythmia diagnosis and lowest adjusted odds of repeat ACM testing. LTCM as a category had the lowest incremental acute care utilization. Different monitoring strategies may produce different results with respect to diagnosis and care., Competing Interests: Disclosures Dr. Reynolds is a consultant for Medtronic, Philips, Edwards Lifesciences, and iRhythm and serves on a data safety and monitoring board for Affera. Dr Passman receives research support from the American Heart Association (#18SFRN34250013), research support and speaker fees from Medtronic, research support from Abbott, royalties from UpToDate, and is a consultant for iRhythm. Dr. Swindle and Dr. Mohammadi have no conflict of interest to disclose. Brent Wright is an employee of iRhythm Technologies. Dr. Boyle is an employee of iRhythm Technologies. Dr. Turakhia is an employee of iRhythm Technologies. Outside of the submitted work, Dr. Turakhia reports research grants from Bristol Myers Squibb, American Heart Association, Bayer, Gilead Sciences, and the Food and Drug Administration, consulting fees from Medtronic, Pfizer, Johnson & Johnson, Alivecor, and equity from iRhythm, Connect America, Forward, and Evidently. Dr. Mittal is a consultant for Boston Scientific and iRhythm Technologies., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Early identification of atrial fibrillation (AF) can reduce the risk of stroke, heart failure, and other serious cardiovascular outcomes. However, paroxysmal AF may not be detected even after a two-week continuous monitoring period. We developed a model to quantify the risk of near-term AF in a two-week period, based on AF-free ECG intervals of up to 24 h from 459,889 patch-based ambulatory single-lead ECG (modified lead II) recordings of up to 14 days. A deep learning model was used to integrate ECG morphology data with demographic and heart rhythm features toward AF prediction. Observing a 1-day AF-free ECG recording, the model with deep learning features produced the most accurate prediction of near-term AF with an area under the curve AUC = 0.80 (95% confidence interval, CI = 0.79-0.81), significantly improving discrimination compared to demographic metrics alone (AUC 0.67; CI = 0.66-0.68). Our model was able to predict incident AF over a two-week time frame with high discrimination, based on AF-free single-lead ECG recordings of various lengths. Application of the model may enable a digital strategy for improving diagnostic capture of AF by risk stratifying individuals with AF-negative ambulatory monitoring for prolonged or recurrent monitoring, potentially leading to more rapid initiation of treatment., (© 2023. The Author(s).)

Background: Wearable devices may be useful for identification, quantification and characterization, and management of atrial fibrillation (AF). To date, consumer wrist-worn devices for AF detection using photoplethysmography-based algorithms perform only periodic checks when the user is stationary and are US Food and Drug Administration cleared for prediagnostic uses without intended use for clinical decision-making. There is an unmet need for medical-grade diagnostic wrist-worn devices that provide long-term, continuous AF monitoring., Methods and Results: We evaluated the performance of a wrist-worn device with lead-I ECG and continuous photoplethysmography (Verily Study Watch) and photoplethysmography-based convolutional neural network for AF detection and burden estimation in a prospective multicenter study that enrolled 117 patients with paroxysmal AF. A 14-day continuous ECG monitor (Zio XT) served as the reference device to evaluate algorithm sensitivity and specificity for detection of AF in 15-minute intervals. A total of 91 857 intervals were contributed by 111 subjects with evaluable reference and test data (18.3 h/d median watch wear time). The watch was 96.1% sensitive (95% CI, 92.7%-98.0%) and 98.1% specific (95% CI, 97.2%-99.1%) for interval-level AF detection. Photoplethysmography-derived AF burden estimation was highly correlated with the reference device burden ( R 2 =0.986) with a mean difference of 0.8% (95% limits of agreement, -6.6% to 8.2%)., Conclusions: Continuous monitoring using a photoplethysmography-based convolutional neural network incorporated in a wrist-worn device has clinical-grade performance for AF detection and burden estimation. These findings suggest that monitoring can be performed with wrist-worn wearables for diagnosis and clinical management of AF., Registration Information: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04546763.

Introduction: Clinical trials provide the "gold standard" evidence for advancing the practice of medicine, even as they evolve to integrate real-world data sources. Modern clinical trials are increasingly incorporating real-world data sources - data not intended for research and often collected in free-living contexts. We refer to trials that incorporate real-world data sources as real-world trials. Such trials may have the potential to enhance the generalizability of findings, facilitate pragmatic study designs, and evaluate real-world effectiveness. However, key differences in the design, conduct, and implementation of real-world vs traditional trials have ramifications in data management that can threaten their desired rigor., Methods: Three examples of real-world trials that leverage different types of data sources - wearables, medical devices, and electronic health records are described. Key insights applicable to all three trials in their relationship to Data and Safety Monitoring Boards (DSMBs) are derived., Results: Insight and recommendations are given on four topic areas: A. Charge of the DSMB; B. Composition of the DSMB; C. Pre-launch Activities; and D. Post-launch Activities. We recommend stronger and additional focus on data integrity., Conclusions: Clinical trials can benefit from incorporating real-world data sources, potentially increasing the generalizability of findings and overall trial scale and efficiency. The data, however, present a level of informatic complexity that relies heavily on a robust data science infrastructure. The nature of monitoring the data and safety must evolve to adapt to new trial scenarios to protect the rigor of clinical trials., Competing Interests: BJB, HH, JDC, JOF, AG, RJ, JL, KOO, MP, KR, HS, MT, & MD have no disclosures. JHC has received research grant support from NIH/National Institute on Drug Abuse Clinical Trials Network (UG1DA015815 - CTN-0136), Stanford Artificial Intelligence in Medicine and Imaging - Human-Centered Artificial Intelligence (AIMI-HAI) Partnership Grant, Doris Duke Charitable Foundation - Covid-19 Fund to Retain Clinical Scientists (20211260), Google, Inc. Research collaboration Co-I to leverage EHR data to predict a range of clinical outcomes, and American Heart Association - Strategically Focused Research Network - Diversity in Clinical Trials. JHC discloses: Co-founder of Reaction Explorer LLC that develops and licenses organic chemistry education software & Paid consulting fees from Sutton Pierce and Younker Hyde MacFarlane PLLC as a medical expert witness. EF is supported in part by AFOSR Grant FA9550-21-1-0397, ONR Grant N00014-22-1-2110, and the Stanford Institute for Human-Centered Artificial Intelligence (HAI). EBF is a Chan Zuckerberg Biohub – San Francisco Investigator. AGo has received research funding from the National Heart, Lung, and Blood Institute; National Institute of Diabetes, Digestive, and Kidney Diseases; and the National Institute on Aging. He has also received research grants through his institution from Novartis, Bristol Myers Squibb, Pfizer, Janssen Research & Development, CSL Behring, iRhythm Technologies, and Amarin Pharmaceuticals. RJ was partially supported by the National Science Foundation under grant 2205084, and by the Stanford Maternal and Child Health Research Institute under the Transdisciplinary Initiatives Program. DMM has had research support from the NIH, JDRF, NSF, and the Helmsley Charitable Trust and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. Dr Maahs has consulted for Abbott, Aditxt, the Helmsley Charitable Trust, Lifescan, Mannkind, Sanofi, Novo Nordisk, Eli Lilly, Medtronic, Insulet, Dompe, Biospex, Provention Bio, and Bayer. DS discloses advising Carta Healthcare. MPT has received grants or personal fees from American Heart Association, Apple, Bayer, Bristol Myers Squibb, FDA, Gilead Sciences, Johnson & Johnson, Medtronic Inc., Myokardia, Pfizer, and Sanofi, is a shareholder of AliveCor, Connect America, Evidently, Forward, iRhythm, and PocketRN, and is an employee of iRhythm Technologies, Inc. KWM’s financial disclosures can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey., (© The Author(s) 2023.)

Background: Sotalol and dronedarone are both used for maintenance of sinus rhythm for patients with atrial fibrillation. However, while sotalol requires initial monitoring for QT prolongation and proarrhythmia, dronedarone does not. These treatments can be used in comparable patients, but their safety and effectiveness have not been compared head to head. Therefore, we retrospectively evaluated the effectiveness and safety using data from a large health care system., Methods: Using Veterans Health Administration data, we identified 11 296 antiarrhythmic drug-naive patients with atrial fibrillation prescribed dronedarone or sotalol in 2012 or later. We excluded patients with prior conduction disease, pacemakers or implantable cardioverter-defibrillators, ventricular arrhythmia, cancer, renal failure, liver disease, or heart failure. We used natural language processing to identify and compare baseline left ventricular ejection fraction between treatment arms. We used 1:1 propensity score matching, based on patient demographics, comorbidities, and medications, and Cox regression to compare strategies. To evaluate residual confounding, we performed falsification analysis with nonplausible outcomes., Results: The matched cohort comprised 6212 patients (3106 dronedarone and 3106 sotalol; mean [±SD] age, 71±10 years; 2.5% female; mean [±SD] CHA 2 DS 2 -VASC, 2±1.3). The mean (±SD) left ventricular ejection fraction was 55±11 and 58±10 for dronedarone and sotalol users, correspondingly. Dronedarone, compared with sotalol, did not demonstrate a significant association with risk of cardiovascular hospitalization (hazard ratio, 1.03 [95% CI, 0.88-1.21]) or all-cause mortality (hazard ratio, 0.89 [95% CI, 0.68-1.16]). However, dronedarone was associated with significantly lower risk of ventricular proarrhythmic events (hazard ratio, 0.53 [95% CI, 0.38-0.74]) and symptomatic bradycardia (hazard ratio, 0.56 [95% CI, 0.37-0.87]). The primary findings were stable across sensitivity analyses. Falsification analyses were not significant., Conclusions: Dronedarone, compared with sotalol, was associated with a lower risk of ventricular proarrhythmic events and conduction disorders while having no difference in risk of incident cardiovascular hospitalization and mortality. These observational data provide the basis for prospective efficacy and safety trials., Competing Interests: Disclosures Dr Pundi reports research grants from the American Heart Association and the American College of Cardiology and is a consultant for Evidently and 100Plus. Dr Kabadi is an employee and shareholder at Sanofi. Dr Blomström-Lundqvist reports personal fees from Bayer, Medtronic, CathPrint, Octopus, Sanofi Aventis, Boston Sci, Merck Sharp & Dohme, Abbotts, and Philips. Dr John Camm reports personal fees from Bayer, Daiichi Sankyo, Pfizer/BMS, Medtronic Abbott, Boston Scientific, Menarini, and Sanofi. Dr Kowey is an ad hoc consultant for Sanofi. Dr Singh is a consultant for Abbott, Biotronik, Boston Sci, Cardiologs, Medtronic, Implicity, Cardiac Rhythm Group, Sanofi, EBR, Microport, Biosense Webster, Sanofi, and Orchestra BioMed. Dr Rashkin is an employee at Sanofi. Dr Wieloch is an employee and shareholder at Sanofi. Dr Turakhia reports research grants from Bristol Myers Squibb, American Heart Association, Apple, Inc, Bayer, and the Food and Drug Administration and is a consultant for Medtronic, Abbott, Biotronik, Sanofi, Pfizer, Myokardia, Johnson & Johnson, Milestone, InCarda, 100Plus, Alivecor, Acutus Medical, and BrightInsight. Dr Sandhu reports research grant 1K23HL151672-01 from the National Heart, Lung, and Blood Institute. The other authors report no conflicts.

Background: Morbidity and mortality associated with high CHA 2 DS 2 -VASc and HAS-BLED scores is not specific to atrial fibrillation (AF). Frailty could be an important contributor to this morbidity and mortality while being mechanistically independent from AF. We sought to evaluate the association of stroke and bleeding risk to noncardiovascular frail events and the association of stroke prevention therapy to outcomes in frail patients with AF., Methods: Using the TREAT-AF (The Retrospective Evaluation and Assessment of Therapies in AF) study from the Veterans Health Administration, we identified patients with newly diagnosed AF from 2004 to 2014. Baseline frailty was identified using a previously validated claims-based index requiring ≥2 of 12 ICD-9 diagnoses. Logistic regressions modeled the association between CHA 2 DS 2 -VASc and modified HAS-BLED and frailty. Cox proportional hazard regressions were used to evaluate the association between CHA 2 DS 2 -VASc and modified HAS-BLED and a composite of noncardiovascular frail events (fractures, urinary tract infections, bacterial pneumonia, or dehydration). We also evaluated the association of oral anticoagulant (OAC) use with stroke, bleeding, and 1-year mortality in frail patients and non-frail patients., Results: In 213,435 patients (age 70 ± 11; 98% male; CHA 2 DS 2 -VASc 2.4 ± 1.7) with AF, 8,498 (4%) were frail. CHA 2 DS 2 -VASc > 0 and HAS-BLED > 0 were strongly associated with frailty (odds ratio [OR] 13.3 (95% CI: 11.6-15.2) for CHA 2 DS 2 -VASc 4+ and OR 13.4 (10.2-17.5) for HAS-BLED 3+). After adjusting for covariates, CHA 2 DS 2 -VASc, and HAS-BLED > 0 were associated with higher risk of non-cardiovascular frail events (hazard ratio [HR] 2.1 (95% CI: 2.0-2.2) for CHA 2 DS 2 -VASc 4+ and HR 1.4 (95% CI: 1.3-1.5) for HAS-BLED 3+). In frail patients, OAC use was associated with significantly lower risk of 1-year mortality (HR 0.82; 95% CI 0.72-0.94, P = .0031) but did not reach significance for risk of stroke (HR 0.80; 95% CI 0.55-1.18, P = .26) or major bleeding (HR 1.08; 95% CI 0.93-1.25, P = .34)., Conclusions: High CHA 2 DS 2 -VASc and HAS-BLED scores are strongly associated with frailty. However, in frail patients, OAC use was associated with reduction in 1-year mortality. For this challenging clinical population with competing risks of frailty and frail events, focused prospective studies are needed to support clinical decision-making. Until then, careful evaluation of frailty should inform shared decision-making., Competing Interests: Conflict of interest K. Pundi: Research grant from the American College of Cardiology. Consulting fees from Evidently and 100Plus., A. Perino: Research support from the American Heart Association and Bristol-Myers Squibb/Pfizer. Consultant for Pfizer and Bristol Myers Squibb., J. Fan: None, N. Din: None, K. Szummer: None, P. Heidenreich: None, M. Turakhia: Research grants from Bristol Myers Squibb, American Heart Association, Apple Inc, Bayer, and the Food and Drug Administration and consulting fees from Medtronic, Abbott, Biotronik, Sanofi, Pfizer, Myokardia, Johnson & Johnson, Milestone, InCarda, 100Plus, Alivecor, Acutus Medical, and BrightInsight., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: There are limited comparative data on safety and efficacy within commonly used Vaughan-Williams (VW) class III antiarrhythmic drugs (AADs) for maintenance of sinus rhythm in adults with atrial fibrillation (AF)., Hypothesis: We hypothesized that dronedarone and sotalol, two commonly prescribed VW class III AADs with class II properties, have different safety and efficacy effects in patients with nonpermanent AF., Methods: A systematic literature review was conducted searching MEDLINE®, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to June 15, 2021 (NCT05279833). Clinical trials and observational studies that evaluated safety and efficacy of dronedarone or sotalol in adults with AF were included. Bayesian random-effects network meta-analysis (NMA) was used to quantify comparative safety and efficacy. Where feasible, we performed sensitivity analyses by including only randomized controlled trials (RCTs)., Results: Of 3581 records identified through database searches, 37 unique studies (23 RCTs, 13 observational studies, and 1 nonrandomized trial) were included in the NMA. Dronedarone was associated with a statistically significantly lower risk of all-cause death versus sotalol (hazard ratio [HR] = 0.38 [95% credible interval, CrI: 0.19, 0.74]). The association was numerically similar in the sensitivity analysis (HR = 0.46 [95% CrI: 0.21, 1.02]). AF recurrence and cardiovascular death results were not significantly different between dronedarone and sotalol in all-studies and sensitivity analyses., Conclusion: The NMA findings indicate that, across all clinical trials and observational studies included, dronedarone compared with sotalol was associated with a lower risk of all-cause death, but with no difference in AF recurrence., (© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: Atrial fibrillation (AF) prevalence estimates vary and have been based on cohorts with clinically established or diagnosed disease. Undiagnosed AF prevalence estimates are less certain as they are based on nongeneralizable convenience samples., Hypothesis: Because AF is often asymptomatic, it my remain undiagnosed until the development of complications such as stroke or heart failure. Consequently, the observed prevalence of diagnosed AF from the literature may underestimate total disease burden. We therefore sought to estimate the total prevalence of both diagnosed and undiagnosed AF., Methods: We performed a retrospective cohort study from 2012 to 2017 using data from five US medical claims data sets. Undiagnosed AF prevalence was estimated based on the observed incidence of ischemic stroke, systemic embolism (SE), and AF incidence after a stroke/SE. The diagnosed AF cohort included AF patients between Q1 2014 and Q3 2015. The undiagnosed AF cohort were patients with assumed undiagnosed AF in the year before a stroke/SE and who were newly diagnosed with AF in the 3-month poststroke/SE. Stroke/SE incidence was calculated among all AF patients and the ratio of number of undiagnosed AF patients to stroke rate was created. Age- and sex-adjusted estimates were stratified by period of assumed undiagnosed AF before poststroke/SE AF diagnosis (1 or 2 years)., Results: The estimated US prevalence of AF (diagnosed and undiagnosed) in Q3 2015 was 5 628 000 cases, of which 591 000 cases (11%) were undiagnosed. The assumed 2-year undiagnosed AF prevalence was 23% (1 531 000) of the total prevalent patients with AF (6 568 000). Undiagnosed (vs. diagnosed) AF patients were older and had higher CHA2DS2-VASc scores. Of undiagnosed AF, 93% had CHA2DS2-VASc ≥2 and met OAC criteria., Conclusions: These contemporary estimates demonstrate the high prevalence of undiagnosed AF in the United States. Undiagnosed AF patients are composed of primarily elderly individuals who if diagnosed, would meet criteria for stroke prevention therapy., (© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown., Methods: Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch irregular rhythm notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were "watch-naïve" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary end point is time from randomization to clinical diagnosis of AF, with confirmation by health care claims. Key secondary endpoint are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, DOAC medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study., Conclusion: The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment., Trial Registration: ClinicalTrials.gov Identifier: NCT04276441., Competing Interests: Conflict of Interest CMG: Research grant support from Johnson & Johnson and Apple. SS: Research grant from Janssen Pharmaceuticals; Employment with PhysIQ, Inc. DL: Research grant from AtriCure and Biosense Webster. Speakers engagement and advisory boards with Medtronic, Abbott, Boston Scientific, Biosense Webster. MPT: Related to the submitted work: Consulting fees from Johnson & Johnson. Outside of the submitted work: consulting fees from Medtronic Inc, Abbott, Pfizer, Sanofi, InCarda, 100Plus, AliveCor, Acutus, Sanofi, Bristol Myers Squibb, Medtronic; grants from Bristol Myers Squibb, American Heart Association, Sanofi, Apple, Bayer, Gilead, US Food and Drug Administration, employment from iRhythm Technologies. RP: Advisory boards for Johnson & Johnson, Abbott, Medtronic; research support Abbott and American Heart Association. WSJ: Research grants from Bayer, Boehringer Ingelheim, Janssen, Merck, Novartis, National Institute on Aging, Patient-Centered Outcomes Research Institute. TJB: Research grant support from Boehringer Ingelheim, Altathera, Boston Scientific. ABC: Advisory board for Janssen Pharmaceuticals, Medtronic Inc., Abbott, Sanofi Aventis, Milestone Pharmaceuticals, Eagle Pharmaceuticals; honoraria for speaking from Medtronic Inc., Abbott, Sanofi Aventis, Milestone Pharmaceuticals. EP: Research support from Janssen, Bristol-Myers Squibb, Amgen, Esperion; Advisory boards for Novartis, Novo Nordisk, Cerner. JR: Advisory boards for Acesion Pharma and InCarda; consultant for Advanced Medical Education, Element Science, GV, Inc.; steering committee for Janssen; stock options for AblaCor, Element Science, InfoBionic, LuxCath, NewPace, Celero Systems. LS: consultant for Abbott and executive committee member for Johnson & Johnson Heartline trial. MT: Employee of Tiltas Solutions; no other competing interests to disclose. KGT: Full-time employee of Medtronic. NM: Consultant for AtriCure Biosense Webster, Sanofi, Pfizer; honoraria for speaking: Biotronik, Bristol Myers Squibb, Sanofi; research grants from Biosense Webster, St. Jude Medical, Johnson & Johnson, Medtronic, Boston Scientific. MP: Employee of and may hold stock in Apple. AH, SK, JN, SJ, KW, and CVD: employees of Janssen and may hold stock in Johnson & Johnson. JAS: Principal investigator of grants from NIH, Abbott Vascular, and the American College of Cardiology Foundation; consultant to Janssen, Novartis, Amgen, Bristol Myers Squibb, AstraZeneca, Bayer, Terumo, Merck; Scientific Advisory Board of UnitedHealthcare and Board of Directors for Blue Cross and Blue Shield of Kansas City; Copyright owner of the KCCQ, SAQ, and PAQ., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Atrial fibrillation (AF) is one of the strongest risk factors for ischemic stroke, which is a leading cause of disability and death. Given the aging population, increasing prevalence of AF risk factors, and improved survival in those with cardiovascular disease, the number of individuals affected by AF will continue increasing over time. While multiple proven stroke prevention therapies exist, important questions remain about the optimal approach to stroke prevention at the population and individual patient levels. Our report summarizes the National Heart, Lung, and Blood Institute virtual workshop focused on identifying key research opportunities related to stroke prevention in AF. The workshop reviewed major knowledge gaps and identified targeted research opportunities to advance stroke prevention in AF in the following areas: (1) improving risk stratification tools for stroke and intracranial hemorrhage; (2) addressing challenges with oral anticoagulants; and (3) delineating the optimal roles of percutaneous left atrial appendage occlusion and surgical left atrial appendage closure/excision. This report aims to promote innovative, impactful research that will lead to more personalized, effective use of stroke prevention strategies in people with AF.

The evidence of direct oral anticoagulants (DOACs) usage for venous thromboembolism (VTE) in patients at extremes of body weight or mass index is limited. In such situations, warfarin may be more frequently used. We investigated warfarin time in the therapeutic international normalized ratio range (TTR) and DOAC adherence based on the calculated proportion of days covered (PDC) by pill coverage from a DOAC prescription in patients with VTE across all body sizes. Using data from the Veterans Health Administration (VA), we identified first-time patients with VTE between 2013 and 2018 treated with warfarin or DOACs. We analyzed 28,245 patients with warfarin TTR (N  =  10,167) or DOAC PDC(N  =  18,078). For warfarin-treated patients after index VTE, mean TTR was lower over shorter treatment durations (TTR 30 vs TTR 180 [mean  ±  SD]: 43.8% ± 33.5% vs 58.8% ± 23.5%). Mean TTR over 180 days after VTE was lowest for patients <60 kg (TTR 180 [mean  ±  SD]: <60kg: 49.3% ± 24.2% vs ≥60 to <100 kg: 57.8% ± 23.4%; P  < .0001). For DOAC-treated patients over 180 days after index VTE, mean PDC was lowest for patients <60 kg (PDC 180 [mean  ±  SD]: < 60kg: 76.9% ± 33.2% vs ≥ 60 to <100 kg: 83.6% ± 27.7%; P  < .0001).Most DOAC-treated patients attained sufficient adherence across the body size spectrum while warfarin-treated patients <60kg were at risk for low TTR.

Importance: Oral anticoagulation (OAC) is underprescribed in underrepresented racial and ethnic group individuals with atrial fibrillation (AF). Little is known of how differential OAC prescribing relates to inequities in AF outcomes., Objective: To compare OAC use at discharge and AF-related outcomes by race and ethnicity in the Get With The Guidelines-Atrial Fibrillation (GWTG-AFIB) registry., Design, Setting, and Participants: This retrospective cohort analysis used data from the GWTG-AFIB registry, a national quality improvement initiative for hospitalized patients with AF. All registry patients hospitalized with AF from 2014 to 2020 were included in the study. Data were analyzed from November 2021 to July 2022., Exposures: Self-reported race and ethnicity assessed in GWTG-AFIB registry., Main Outcomes and Measures: The primary outcome was prescription of direct-acting OAC (DOAC) or warfarin at discharge. Secondary outcomes included cumulative 1-year incidence of ischemic stroke, major bleeding, and mortality postdischarge. Outcomes adjusted for patient demographic, clinical, and socioeconomic characteristics as well as hospital factors., Results: Among 69 553 patients hospitalized with AF from 159 sites between 2014 and 2020, 863 (1.2%) were Asian, 5062 (7.3%) were Black, 4058 (5.8%) were Hispanic, and 59 570 (85.6%) were White. Overall, 34 113 (49.1%) were women; the median (IQR) age was 72 (63-80) years, and the median (IQR) CHA2DS2-VASc score (calculated as congestive heart failure, hypertension, age 75 years and older, diabetes, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, and sex category) was 4 (2-5). At discharge, 56 385 patients (81.1%) were prescribed OAC therapy, including 41 760 (74.1%) receiving DOAC. OAC prescription at discharge was lowest in Hispanic patients (3010 [74.2%]), followed by Black patients (3935 [77.7%]) Asian patients (691 [80.1%]), and White patients (48 749 [81.8%]). Black patients were less likely than White patients to be discharged while taking any anticoagulant (adjusted odds ratio, 0.75; 95% CI, 0.68-0.84) and DOACs (adjusted odds ratio, 0.73; 95% CI, 0.65-0.82). In 16 307 individuals with 1-year follow up data, bleeding risks (adjusted hazard ratio [aHR], 2.08; 95% CI, 1.53-2.83), stroke risks (aHR, 2.07; 95% CI, 1.34-3.20), and mortality risks (aHR, 1.22; 95% CI, 1.02-1.47) were higher in Black patients than White patients. Hispanic patients had higher stroke risk (aHR, 2.02; 95% CI, 1.38-2.95) than White patients., Conclusions and Relevance: In a national registry of hospitalized patients with AF, compared with White patients, Black patients were less likely to be discharged while taking anticoagulant therapy and DOACs in particular. Black and Hispanic patients had higher risk of stroke compared with White patients; Black patients had a higher risk of bleeding and mortality. There is an urgent need for interventions to achieve pharmacoequity in guideline-directed AF management to improve overall outcomes.

An app-based clinical trial enrolment process can contribute to duplicated records, carrying data management implications. Our objective was to identify duplicated records in real time in the Apple Heart Study (AHS). We leveraged personal identifiable information (PII) to develop a dissimilarity score (DS) using the Damerau-Levenshtein distance. For computational efficiency, we focused on four types of records at the highest risk of duplication. We used the receiver operating curve (ROC) and resampling methods to derive and validate a decision rule to classify duplicated records. We identified 16,398 (4%) duplicated participants, resulting in 419,297 unique participants out of a total of 438,435 possible. Our decision rule yielded a high positive predictive value (96%) with negligible impact on the trial's original findings. Our findings provide principled solutions for future digital trials. When establishing deduplication procedures for digital trials, we recommend collecting device identifiers in addition to participant identifiers; collecting and ensuring secure access to PII; conducting a pilot study to identify reasons for duplicated records; establishing an initial deduplication algorithm that can be refined; creating a data quality plan that informs refinement; and embedding the initial deduplication algorithm in the enrolment platform to ensure unique enrolment and linkage to previous records., (© 2022 The Authors. Stat published by John Wiley & Sons Ltd.)

Introduction: Atrial fibrillation (AF) disproportionally affects persons on maintenance hemodialysis (HD). Associations of serum and dialysate potassium concentrations [K + ] with AF incidence are poorly understood., Methods: We conducted a cohort study using Medicare claims merged with clinical data from a dialysis provider to determine whether serum-[K + ] and/or dialysate-[K + ] independently associated with AF incidence. Persons insured by fee-for-service Medicare aged ≥67 years at dialysis initiation and free from diagnosed AF prior to day 120 of dialysis were eligible. Serum-[K + ] and dialysate-[K + ] were assessed in 30-day intervals and patients were followed-up with for AF incidence in subsequent 30-day intervals., Results: During 2006 to 2011, 15,190 persons (mean age = 76.3 years) initiating HD had no prior AF diagnosis. Mean serum-[K + ] was 4.5 mEq/l; dialysate-[K + ] was 3 mEq/l in 34% and 2 mEq/l in 52% of patients. Followed-up over 21,907 person-years, 2869 persons had incident AF (incidence/100 person-years, 13.1 [95% confidence interval [CI], 12.6-13.6]). The multivariable-adjusted association of serum-[K + ] with incident AF was J-shaped as follows: relative to a serum-[K + ] of 4.5 mEq/l, lower serum-[K + ] associated with increased AF risk, whereas confidence bands for higher serum-[K + ] indicated no association. Dialysis against a dialysate-[K+] of 3 mEq/l versus 2 mEq/l independently associated with a 14% (95% CI, 5%-24%) lower incidence of AF. No effect modification between serum-[K + ] and dialysate-[K + ] was detected ( P  = 0.34)., Conclusion: Lower serum-[K + ] was independently associated with incident AF whereas elevated serum-[K+] was not. The findings support adoption of dialysate solutions with a dialysate-[K + ] of 3 mEq/l, regardless of patients' serum-[K+], and elimination of lower dialysate-[K+] solutions from practice. Clinical trials randomizing patients to different dialysate-[K + ] are warranted to establish causality., (© 2022 Published by Elsevier Inc. on behalf of the International Society of Nephrology.)

The technological evolution and widespread availability of wearables and handheld ECG devices capable of screening for atrial fibrillation (AF), and their promotion directly to consumers, has focused attention of health care professionals and patient organizations on consumer-led AF screening. In this Frontiers review, members of the AF-SCREEN International Collaboration provide a critical appraisal of this rapidly evolving field to increase awareness of the complexities and uncertainties surrounding consumer-led AF screening. Although there are numerous commercially available devices directly marketed to consumers for AF monitoring and identification of unrecognized AF, health care professional-led randomized controlled studies using multiple ECG recordings or continuous ECG monitoring to detect AF have failed to demonstrate a significant reduction in stroke. Although it remains uncertain if consumer-led AF screening reduces stroke, it could increase early diagnosis of AF and facilitate an integrated approach, including appropriate anticoagulation, rate or rhythm management, and risk factor modification to reduce complications. Companies marketing AF screening devices should report the accuracy and performance of their products in high- and low-risk populations and avoid claims about clinical outcomes unless improvement is demonstrated in randomized clinical trials. Generally, the diagnostic yield of AF screening increases with the number, duration, and temporal dispersion of screening sessions, but the prognostic importance may be less than for AF detected by single-time point screening, which is largely permanent, persistent, or high-burden paroxysmal AF. Consumer-initiated ECG recordings suggesting possible AF always require confirmation by a health care professional experienced in ECG reading, whereas suspicion of AF on the basis of photoplethysmography must be confirmed with an ECG. Consumer-led AF screening is unlikely to be cost-effective for stroke prevention in the predominantly young, early adopters of this technology. Studies in older people at higher stroke risk are required to demonstrate both effectiveness and cost-effectiveness. The direct interaction between companies and consumers creates new regulatory gaps in relation to data privacy and the registration of consumer apps and devices. Although several barriers for optimal use of consumer-led screening exist, results of large, ongoing trials, powered to detect clinical outcomes, are required before health care professionals should support widespread adoption of consumer-led AF screening.

Digital technology is now an integral part of medicine. Tools for detecting, screening, diagnosis, and monitoring health-related parameters have improved patient care and enabled individuals to identify issues leading to better management of their own health. Wearable technologies have integrated sensors and can measure physical activity, heart rate and rhythm, and glucose and electrolytes. For individuals at risk, wearables or other devices may be useful for early detection of atrial fibrillation or sub-clinical states of cardiovascular disease, disease management of cardiovascular diseases such as hypertension and heart failure, and lifestyle modification. Health data are available from a multitude of sources, namely clinical, laboratory and imaging data, genetic profiles, wearables, implantable devices, patient-generated measurements, and social and environmental data. Artificial intelligence is needed to efficiently extract value from this constantly increasing volume and variety of data and to help in its interpretation. Indeed, it is not the acquisition of digital information, but rather the smart handling and analysis that is challenging. There are multiple stakeholder groups involved in the development and effective implementation of digital tools. While the needs of these groups may vary, they also have many commonalities, including the following: a desire for data privacy and security; the need for understandable, trustworthy, and transparent systems; standardized processes for regulatory and reimbursement assessments; and better ways of rapidly assessing value., Competing Interests: Conflict of interest: C.L. receives consulting fees from Medtronic, Boston Scientific, Abbott, and Biotronik; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Medtronic, Boston Scientific, Abbott, and Biotronik. H.W. has stock or stock options from Pfizer. R.P.K. has stock or stock options from Medtronic; and employment by Medtronic. D.A. has multiple patents including those for AliveCor, and GE assignments; stock or stock options from AliveCor, Inc.; and salary/officer position with AliveCor, Inc. M.R.C. receives consulting fees from AstraZeneca, Servier, Medtronic, and Abbott; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AstraZeneca, Servier, Medtronic, Abbott, and Bayer; served as Chair for ESC-Digital Health Committee (unpaid), Chair for Clinical Advisory Board of Pumping Marvellous Foundation (unpaid), Trustee of the Atrial Fibrillation Association (unpaid), and Non-executive Director of NICE from 2016-2020 (paid). T.D. receives consulting fees from Farapulse; payment or honoraria for lectures from Biotronik and Abbott; participation on a clinical events committee for Boston Scientific; served as a board member for the German Cardiology Society. P.F. participated on advisory board for Abbot, Medtronic, and Boston Scientific; IP, licensing fees, and equity stake via Mayo Clinic (employer) in AliveCor, EkoHealth, and Anuman. I.L. has stock or stock options from Amgen; and employment by Amgen. M.V.M. served as Co-Chair for the Consumer Technology Association (CTA)-American College of Cardiology (ACC) CV Technology Working Group; stock or stock options from Google; and employment by Google. L.R. supports for the present manuscript from Medtronic; employment by Medtronic. E.S. has stock or stock options from GE Healthcare; and employment by GE Vingmed Ultrasound AS. M.P.T. receives consulting fees from Medtronic, Abbott, Biotronik, Sanofi, Pfizer, Bayer, Myokardia, Johnson & Johnson, Milestone Pharmaceuticals, InCarda Pharmaceuticals, 100Plus, AliveCor, Actus Medical, and BrightInsight; grants from Bristol-Myers Squibb, American Heart Association, Apple, Bayer, and the US Food and Drug Administration; and editorship with JAMA Cardiology. J.P.S. receives consulting fees from Abbott, Biotronik, Boston Scientific, Cardiologs, CVRx, Cardiac Rhythm Group, EBR, Impulse Dynamics, Implicity, Medtronic, Medscape, Microport, New Century Health, Nopras, Orchestra BioMed, Octagos Health, and Sanofi. E.S. receives institutional research grants from the Stockholm County Council, the Åke Wiberg Foundation, and the Swedish Heart Foundation; consulting fees from Bayer, Bristol-Myers Squibb-Pfizer, Boehringer-Ingelheim, Johnson & Johnson, Merck Sharp & Dohme; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Bayer, Johnson & Johnson, Merck Sharp & Dohme, Bristol-Myers Squibb-Pfizer, Boehringer-Ingelheim; participation on a data safety monitoring board or advisory board for Bristol-Myers Squibb-Pfizer; board membership for the European Heart Rhythm Association (EHRA), served as Chair of the Digital Committee for EHRA, and membership on the Digital Committee of the Heart Rhythm Society. M.W. supports for the present manuscript from Biotelemetry; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Biotelemetry; support for meeting attendance and/or travel from Biotelemetry; patents for Biotelemetry; stock or stock options from Biotelemetry. Other authors have none to declare., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

This study aims to evaluate trends in guideline-directed medical therapy (GDMT) for patients with recent-onset heart failure with reduced ejection fraction (HFrEF) following the onset of the COVID-19 pandemic using an interrupted time series analysis in the Veteran's Affairs Healthcare System. Among 71,428 patients with recent-onset HFrEF between 1/1/2018 and 2/28/2021, we found the pandemic was not associated with differences in treatment rates for beta-blockers, renin-angiotensin-aldosterone system inhibitors, or mineralocorticoid receptor antagonists; there was a 2.6 % absolute decrease (95 % CI: 0.5 %-4.7 %) in ARNI rates in April 2020; which decreased over the pandemic. Despite the changes to healthcare delivery, the COVID-19 pandemic was associated with minimal changes in GDMT rates among patients with recent-onset HFrEF., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AS consults for Acumen, LLC. SK reports receiving unrestricted grants from Novartis and personal fees from Bayer and Bristol-Myers Squibb outside the submitted work. MPT reports employment from iRhythm Technologies, Inc., personal fees from Medtronic Inc., personal fees from Abbott, grants from Bristol Myers Squibb, grants from American Heart Association, personal fees from Biotronik, personal fees from Sanofi, personal fees from Pfizer, grants from Apple, grants and personal fees from Bayer, personal fees from Myokardia, personal fees from Johnson & Johnson, personal fees from Milestone Pharmaceuticals, outside the submitted work., (Published by Elsevier Inc.)

Background: In patients with atrial fibrillation (AF) treated with direct oral anticoagulants (DOAC), bleeding risk scores provide only modest discrimination for major or intracranial bleeding. However, warfarin experience may impact HAS-BLED  (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (>65 years), Drugs/alcohol concomitantly) score performance in patients evaluated for DOACs, as HAS-BLED was derived and validated in warfarin cohorts., Methods: We performed a retrospective cohort study of patients prescribed DOAC for AF in the Veterans Health Administration between 2010 and 2017. We determined modified HAS-BLED score discrimination and calibration for bleeding, for patients treated with DOAC, stratified by prior warfarin exposure. We also determined the association between DOAC-warfarin-naïve status to bleeding (nonintracranial and intracranial) with DOAC-warfarin-experienced patients as reference., Results: The DOAC analysis cohort included 100, 492 patients with AF (age [mean ± SD]: 72.9 ± 9.6 years; 1.7% female; 90.1% White), of which 26, 760 patients (26.6%) and 73, 732 patients (73.4%) were warfarin experienced or naïve, respectively. HAS-BLED discrimination for bleeds was modest for patients treated with DOAC, regardless of prior warfarin experience (concordance statistics: 0.53-0.59). For DOAC-warfarin-naïve patients, as compared to DOAC-warfarin-experienced patients, adjusted risk of intracranial bleeding was lower, while risk of nonintracranial bleeding was higher (intracranial bleeding propensity adjusted with inverse probability of treatment weights [IPTWs]: hazard ratio [HR]: 0.86, 95% confidence interval [CI]: 0.78-0.95, p = .0040) (nonintracranial bleeding propensity adjusted with IPTW: HR: 1.15, 95% CI: 1.11-1.19, p < .0001)., Conclusion: Patients' modified HAS-BLED score at the time of DOAC initiation, regardless of prior warfarin use, provided only modest discrimination for intracranial and nonintracranial bleeds. These data argue against maintaining DOAC eligible patients on warfarin therapy regardless of modified HAS-BLED score., (© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials., (© 2022. The Author(s).)

The considerable mortality and morbidity associated with atrial fibrillation (AF) pose a substantial burden on patients and health care services. Although the management of AF historically focused on decreasing AF recurrence, it evolved over time in favor of rate control. Recently, more emphasis has been placed on reducing adverse cardiovascular outcomes using rhythm control, generally by using safe and effective rhythm-control therapies (typically antiarrhythmic drugs and/or AF ablation). Evidence increasingly supports early rhythm control in patients with AF that has not become long-standing, but current clinical practice and guidelines do not yet fully reflect this change. Early rhythm control may effectively reduce irreversible atrial remodeling and prevent AF-related deaths, heart failure, and strokes in high-risk patients. It has the potential to halt progression and potentially save patients from years of symptomatic AF; therefore, it should be offered more widely., Competing Interests: Funding Support and Author Disclosures This work was supported by Sanofi for editorial assistance with article preparation only. Dr Camm has received consulting fees from Allergan, Arca, Acesion, Incarda, Menarini, Milestone, Sanofi, Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Pfizer, Boston Scientific, Abbott, Biotronik, Medtronic, and Johnson and Johnson; and has received institutional grants from Bayer, Boehringer Ingelheim, Daichi-Sankyo, and Pfizer/Bristol Myers Squibb. Dr Naccarelli has received consultant fees from ARCA, Sanofi, Janssen, GlaxoSmithKline, Omeicos, Milestone, and Acesion. Dr Mittal has received consultant fees from Abbott, Baylis Medical, Boston Scientific, Medtronic, Philips, and Sanofi. Dr Crijns has received consultant/advisor/speaker fees from Acesion, Incarda, Sanofi, Roche, Ksyos, Corsano Health, and DZHK; has received support for educational activities from Medtronic, Abbott, and Boston Scientific; and has been supported by ZonMw (grant number 104021005 - RACE 9). Dr Hohnloser has received consulting fees from Bayer Healthcare, Boehringer Ingelheim, Bristol Myers Squibb, Boston Scientific, Daiichi-Sankyo, Gilead, Johnson & Johnson, Medtronic, Pfizer, Sanofi, Servier, and Zoll; and has received lecture fees from Bayer Healthcare, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Pfizer, Sanofi, and Medtronic. Dr Ma has received honoraria from Bristol Myers Squibb, Pfizer, Johnson & Johnson, Boehringer Ingelheim, and Bayer for giving lectures; no personal fees received. Dr Natale has been a consultant for Abbott, Baylis, Biosense Webster, Boston Scientific, Biotronik, and Medtronic. Dr Turakhia has received personal fees from Medtronic Inc, Abbott, Biotronik, Sanofi, Pfizer, Bayer, Myokardia, Johnson and Johnson, Milestone Pharmaceuticals, InCarda Pharmaceuticals, 100Plus, AliveCor, Acutus Medical, and BrightInsight; has received grants from Bristol Myers Squibb, the American Heart Association, Apple, Bayer, and the U.S. Food and Drug Administration; and is an editor for JAMA Cardiology. Dr Kirchof has received research support for basic, translational, and clinical research projects from European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (UK), German Centre for Cardiovascular Research, and from several drug and device companies active in atrial fibrillation; has received honoraria from several such companies in the past, but not in the last 3 years; is listed on 2 patents held by the University of Birmingham (Atrial Fibrillation Therapy WO 2015140571 and Markers for Atrial Fibrillation WO 2016012783); and has been partially supported by European Union BigData@Heart (grant agreement EU IMI 116074), AFFECT-AF (grant agreement 847770), and MAESTRIA (grant agreement 965286), British Heart Foundation (PG/17/30/32961 and PG/20/22/35093; AA/18/2/34218), German Centre for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK), and Leducq Foundation., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry., Methods: From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019. We described patient-level attainment and variation in attainment across sites of 6 achievement measures with 1) defect-free scores (percent of patients with all eligible measures attained), and 2) composite opportunity scores (percent of all eligible patient measures attained). We also described attainment of 11 quality measures at the patient-level., Results: Among 80,951 patients hospitalized for AF (age 70±13 years, 47.0% female; CHA 2 DS 2 -VASc 3.6±1.8) at 132 sites. Site-level defect-free scores ranged from 4.7% to 85.8% (25 th , 50 th , 75 th percentile: 32.7%, 52.1%, 64.4%). Composite opportunity scores ranged from 39.4% to 97.5% (25 th , 50 th , 75 th : 68.1%, 80.3%, 87.1%). Attainment was notably low for the following quality measures: 1) aldosterone antagonist prescription when ejection fraction ≤35% (29% of those eligible); and 2) avoidance of antiplatelet therapy with OAC in patients without coronary/peripheral artery disease (81% of those eligible)., Conclusions: Despite high overall attainment of care measures across GWTG-AFIB registry sites, large site variation was present with meaningful opportunities to improve AF care beyond OAC prescription, including but not limited to prescription of aldosterone antagonists in those with AF and systolic dysfunction and avoidance of non-indicated adjunctive antiplatelet therapy., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: Multiple guideline-recommended therapies for heart failure with reduced ejection fraction (HFrEF) are available and promoted by performance measures. However, contemporary data on the use of these therapies are limited., Objective: To evaluate trends in guideline-directed medical therapy, implantable cardioverter-defibrillator (ICD) use, and risk-adjusted mortality among patients with recent-onset HFrEF., Design, Setting, and Participants: This cohort study analyzed claims and electronic health record data of patients with recent-onset HFrEF diagnosed at US Department of Veterans Affairs (VA) health care system facilities from July 1, 2013, through June 30, 2019. Veterans who had a history of heart transplant or used a ventricular assist device were among the patients who were excluded., Exposures: Guideline-directed medical therapy (any β-blocker, guideline-recommended β-blocker [bisoprolol, carvedilol, or metoprolol succinate], angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, angiotensin receptor-neprilysin inhibitor, mineralocorticoid receptor antagonist, and hydralazine plus nitrate) and ICD., Main Outcomes and Measures: Treatment rates for guideline-directed medical therapies and ICDs were calculated within 6 months of the index HFrEF date using medication fills, procedural codes for implantation and monitoring, and diagnosis codes. Risk-adjusted mortality was calculated after adjusting for baseline patient characteristics. For both treatment rates and risk-adjusted mortality, we evaluated the change over 3 periods (period 1: July 1, 2013, to June 30, 2015; period 2: July 1, 2015, to June 30, 2017; and period 3: July 1, 2017, to June 30, 2019) and variation across VA facilities., Results: The final cohort comprised 144 074 eligible patients with incident HFrEF that was diagnosed between July 1, 2013, and June 30, 2019. The cohort had a mean (SD) age of 71.0 (11.4) years and was mostly composed of men (140 765 [97.7%]). Overall, changes in medical therapy rates were minimal over time, with the use of a guideline-recommended β-blocker increasing from 64.2% in 2013 to 72.0% in 2019. Rates for mineralocorticoid receptor antagonist therapy increased from 23.9% in 2013 to 26.9% in 2019, and rates for hydralazine plus nitrate therapy remained stable at 24.2% over the study period. Rates for angiotensin receptor-neprilysin inhibitor therapy increased since its introduction in 2015 but only to 22.6% in 2019. Among patients with an ICD indication, early use rates decreased over time. Substantial variation in medical therapy rates persisted across VA facilities. Risk-adjusted mortality decreased over the study period from 19.9% (95% CI, 19.6%-20.2%) in July 1, 2013, to June 30, 2015, to 18.4% (95% CI, 18.0%-18.7%) in July 1, 2017, to June 30, 2019 (OR, 0.96 per additional year; 95% CI, 0.96-0.97)., Conclusions and Relevance: This study found only marginal improvement between 2013 and 2019 in the guideline-recommended therapy and mortality rates among patients with recent-onset HFrEF. New approaches to increase the uptake of evidence-based HFrEF treatment are urgently needed and could lead to larger reductions in mortality.

Background Reduced time in international normalized ratio therapeutic range (TTR) limits warfarin safety and effectiveness. In patients switched from warfarin to direct oral anticoagulants (DOACs), patient factors associated with low TTR could also increase risk of DOAC nonadherence. We investigated the relationship between warfarin TTR and DOAC adherence in warfarin-treated patients with atrial fibrillation switched to DOAC. Methods and Results Using data from the Veterans Health Administration, we identified patients with atrial fibrillation switched from warfarin to DOAC (switchers) or treated with warfarin alone (non-switchers). Logistic regression was used to evaluate association between warfarin TTR and DOAC adherence. We analyzed 128 605 patients (age, 71±9; 1.6% women; CHA 2 DS 2 -VASc 3.5±1.6); 32 377 switchers and 96 228 non-switchers. In 8016 switchers with international normalized ratio data to calculate 180-day TTR before switch, TTR was low (median 0.45; IQR, 0.26-0.64). Patients with TTR <0.5 were more likely to be switched to DOAC (odds ratio [OR],1.68 [95% CI,1.62-1.74], P <0.0001), as were those with TTR <0.6 or TTR <0.7. Proportion of days covered ≥0.8 was achieved by 76% of switchers at 365 days. In low-TTR individuals, proportion of days covered ≥0.8 was achieved by 70%, 72%, and 73% of switchers with TTR <0.5, 0.6, and 0.7, respectively. After multivariable adjustment, TTR <0.5 decreased odds of achieving 365-day proportion of days covered ≥0.8 (OR, 0.49; 0.43-0.57, P <0.0001), with similar relationships for TTR <0.6 and TTR <0.7. In non-switchers with TTR <0.5, long-term TTR remained low. Conclusions In patients with atrial fibrillation switched from warfarin to DOAC, most achieved adequate DOAC adherence despite low pre-switch TTRs. However, TTR trajectories remained low in non-switchers. Patients with low warfarin TTR more consistently achieved treatment targets after switching to DOACs, although adherence-oriented interventions may be beneficial.

Background: Chronic Kidney Disease (CKD) and end-stage renal disease (ESRD) are associated with poor outcomes in patients with cardiovascular disease. There is a paucity of contemporary data on in-hospital outcomes and care patterns of atrial fibrillation (AF) associated hospitalizations CKD and ESRD., Methods: Outcomes and care patterns were evaluated in GWTG-AFIB database (Jan 2013-Dec 2018), including in-hospital mortality, use of a rhythm control strategy, and oral anticoagulation (OAC) prescription at discharge among eligible patients. Generalized logistic regression models with generalized estimating equations were used to ascertain differences in outcomes. Hospital-level variation in OAC prescription and rhythm control was also evaluated., Results: Among 50,154 patients from 105 hospitals the median age was 70 years (interquartile range 61-79) and 47.3% were women. The prevalence of CKD was 36.0% while that of ESRD was 1.6%. Among eligible patients, discharge OAC prescription rates were 93.6% for CKD and 89.1% for ESRD. After adjustment, CKD and ESRD were associated with higher in-hospital mortality (odds ratio [OR] 3.08, 95% confidence interval [CI] 1.57-6.03 for ESRD and OR 2.02, 95% CI 1.52-2.67 for CKD), lower odds of OAC prescription at discharge (OR 0.59, 95% CI 0.44-0.79 for ESRD and OR 0.84, 95% CI 0.75-0.94 for CKD) compared with normal renal function. CKD was associated with lower utilization of rhythm control strategy (OR 0.92, 95% CI 0.87-0.98) with no significant difference between ESRD and normal renal function (OR 1.32, 95% CI 0.79-1.11). There was large hospital-level variation in OAC prescription at discharge (MOR 2.34, 95% CI 2.05-2.76) and utilization of a rhythm control strategy (MOR 2.69, 95% CI 2.34-3.21)., Conclusions: CKD/ESRD is associated with higher in-hospital mortality, less frequent rhythm control, and less OAC prescription among patients hospitalized for AF. There is wide hospital-level variation in utilization of a rhythm control strategy and OAC prescription at discharge highlighting potential opportunities to improve care and outcomes for these patients, and better define standards of care in this patient population., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Consensus statements have recommended against the use of direct oral anticoagulants (DOACs) in venous thromboembolism (VTE) for patients ≥120 kg and ≥40 kg/m 2 . We sought to determine use and outcomes of DOACs for VTE across weight and body mass index (BMI)., Methods: We performed a retrospective cohort study of patients with first-time VTE 2013 to 2018 that were treated with DOAC or warfarin in the Veterans Health Administration. The Veterans Health Administration has implemented system-wide guidance for patient selection and shared decision-making for use of DOACs in VTE at extremes of weight. We stratified patients by weight and BMI and assessed (1) association of weight and BMI category to outcomes in those prescribed DOAC; and (2) association of DOAC, as compared to warfarin, to outcomes by weight and BMI categories. Outcomes of interest included major bleeding, clinically relevant nonmajor bleeding, and recurrent VTE., Results: The analysis cohort included 51 871 patients prescribed DOAC or warfarin within 30 days of index VTE diagnosis (age 64.5±13.1 years; 6.0% female; median weight 93.4 kg [25th-75th: 80.5-108.6 kg]). For patients ≥120 kg (N=6934 patients), 38.4% were treated with DOAC, as compared to 45.4% of those ≥60 to <100 kg (N=30 645; P <0.0001). DOAC prescription was not associated with major bleeds, clinically relevant nonmajor bleeds, or recurrent VTE for those in higher weight and BMI categories as compared to those in average weight and BMI categories. DOAC prescription, as compared to warfarin, was not associated with increased recurrent VTE in any weight or BMI category., Conclusions: Patients ≥120 kg and ≥40 kg/m 2 with VTE are frequently prescribed DOAC by the Veterans Health Administration, without an increase in bleeding or recurrent VTE. These findings suggest DOACs can be safe and effective in this population and may argue for broader adoption of pharmacy policies that promote careful patient selection and shared decision making.

Background: When presenting for atrial fibrillation (AF) ablation, women, compared with men, tend to have more nonpulmonary vein triggers and advanced atrial disease. Whether this informs differences in AF ablation strategy is not well described. We aimed to characterize ablation strategy and complications by sex, using the Get With The Guidelines-AF registry., Methods: From the Get With The Guidelines-AF registry ablation feature, we included patients who underwent initial AF ablation procedure between January 7, 2016, and December 27, 2019. Patients were stratified based on AF type (paroxysmal versus nonparoxysmal) and sex. We compared patient demographics, ablation strategy, and complications by sex., Results: Among 5356 patients from 31 sites who underwent AF ablation, 1969 were women (36.8%). Women, compared with men, were older (66.8±9.6 versus 63.4±10.6, P <0.0001) and were more likely to have paroxysmal AF (59.4% versus 49.5%, P <0.0001). In women with nonparoxysmal AF, left atrial linear ablation was more frequent (roof line: 53.9% versus 45.3%, P =0.0002; inferior mitral isthmus line: 10.2% versus 7.0%, P =0.01; floor line: 46.1% versus 40.6%, P =0.02) than in men. In multivariable analysis, the association between patient sex and complications from ablation was not statistically significant., Conclusions: In this US wide AF ablation quality improvement registry, women with nonparoxysmal AF were more likely to receive adjunctive lesion sets compared with men. These findings suggest that patient sex may inform ablation strategy in ways that may not be strongly supported by evidence and emphasize the need to clarify optimal ablation strategies by sex.

Background: Kidney function may promote progression of AF., Objective: We evaluated the association of kidney function to AF progression and resultant clinical outcomes in patients with cardiac implantable electronic devices (CIED)., Methods: We performed a retrospective cohort study using national clinical data from the Veterans Health Administration linked to CIED data from the Carelink® remote monitoring data warehouse (Medtronic Inc, Mounds View, MN). All devices had atrial leads and at least 75% of remote monitoring transmission coverage. Patients were included at the date of the first AF episode lasting ≥6 minutes, and followed until the occurrence of persistent AF in the first year, defined as ≥7 consecutive days with continuous AF. We used Cox regression analyses with persistent AF as a time-varying covariate to examine the association to stroke, myocardial infarction, heart failure and death., Results: Of, 10,323 eligible patients, 1,771 had a first CIED-detected AF (mean age 69 ± 10 years, 1.2% female). In the first year 355 (20%) developed persistent AF. Kidney function was not associated with persistent AF after multivariable adjustment including CHA 2 DS 2 -VASc variables and prior medications. Only higher age increased the risk (HR: 1.37 per 10 years; 95% CI:1.22-1.54). Persistent AF was associated to higher risk of heart failure (HR: 2.27; 95% CI: 1.88-2.74) and death (HR: 1.60; 95% CI: 1.30-1.96), but not stroke (HR: 1.28; 95% CI: 0.62-2.62) or myocardial infarction (HR: 1.43; 95% CI: 0.91-2.25)., Conclusion: Kidney function was not associated to AF progression, whereas higher age was. Preventing AF progression could reduce the risk of heart failure and death., (Published by Elsevier Inc.)

Purpose: Optimal stroke prevention strategies for patients with atrial fibrillation (AF) who experience a major bleed are poorly defined. We sought to estimate the effectiveness and safety of oral anticoagulation (OAC) represcription after an OAC contraindication., Methods: TREAT-AF is a retrospective cohort study of patients with newly diagnosed AF (2004-2012), treated in the Veterans Health Administration. From this cohort, we identified patients with a contraindication to OAC after AF diagnoses, defined as incident intracranial bleeding, non-intracranial bleeding requiring hospitalization, or unrepaired cerebral aneurysm or aortic dissection. We used multivariate Cox proportional hazards to estimate the association of OAC prescription in the 90 days following OAC contraindication to ischemic stroke and rebleeding., Results: Among 167,190 patients with newly diagnosed AF (70 ± 11 years, 1.7% female, CHA 2 DS 2 -VASc 2.7 ± 1.7), 19,285 patients (11.5%) had an incident bleed (n = 18,342) or an unrepaired cerebral aneurysm or aortic dissection (n = 943). For OAC-contraindicated patients with a CHA 2 DS 2 -VASc ≥2 (N = 16,194), OAC was represcribed in 4075 patients (25%) and was associated with a higher risk of non-intracranial bleeding (HR 1.49; 95% CI 1.37-1.61; p < 0.0001) but no difference in intracranial bleeding. There was a trend toward decreased stroke risk (HR 0.85; 95% CI 0.71-1.02; p 0.09)., Conclusions: Development of contraindication to OAC after diagnosis of AF is common (11.5%), with most events requiring hospitalization. OAC reinitiation was associated with non-intracranial bleeding risk, with a trend toward reduced stroke risk. These data suggest that stroke prevention approaches after major bleeding events could be beneficial if bleeding risk can be successfully mitigated., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

[Figure: see text].

This study sought to evaluate inappropriate prescribing practices in an atrial fibrillation (AF) population, as outlined by the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults with Atrial Fibrillation or Atrial Flutter document. The 2016 AF quality measures document specified medications to avoid in certain AF populations, including aspirin and anticoagulant combination therapy in patients without cardiovascular disease, and non-dihydropyridine calcium channel blockers in patients with reduced ejection fraction. Using data from the NCDR PINNACLE registry, a national outpatient cardiology practice registry, we assessed rates of inappropriate prescription of two types of medications among AF outpatients from 5/1/2008-5/1/2016. Overall rates of inappropriate prescription and variation by practice were calculated. Patient and practice factors associated with inappropriate prescription were assessed in adjusted analyses. A total of 107,759 of 658,250 (16.4%) patients without cardiovascular disease were inappropriately prescribed an antiplatelet and anticoagulant together, and 5,731 of 150,079 (3.8%) patients with reduced ejection fraction were inappropriately prescribed a non-dihydropyridine calcium channel blocker. Overall, 14.8% of AF patients were prescribed medications that were not recommended. Both patient and practice factors were associated with inappropriate prescribing, and the adjusted practice-level median odds ratio for inappropriate prescription was 1.70 (95% CI: 1.61-1.82), indicating a 70% likelihood that 2 random practices would treat identical AF patients differently. In a large registry of AF patients treated in cardiology practices, overall rates of inappropriate prescription practices, as defined by the 2016 AF quality measures, were relatively low, but significant practice variation was present., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console., Objective: To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods., Methods: The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical "control" groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless)., Results: Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber)., Conclusion: The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM., (© 2021 Heart Rhythm Society. Published by Elsevier Inc.)

Technological innovations reach deeply into our daily lives and an emerging trend supports the use of commercial smart wearable devices to manage health. In the era of remote, decentralized and increasingly personalized patient care, catalysed by the COVID-19 pandemic, the cardiovascular community must familiarize itself with the wearable technologies on the market and their wide range of clinical applications. In this Review, we highlight the basic engineering principles of common wearable sensors and where they can be error-prone. We also examine the role of these devices in the remote screening and diagnosis of common cardiovascular diseases, such as arrhythmias, and in the management of patients with established cardiovascular conditions, for example, heart failure. To date, challenges such as device accuracy, clinical validity, a lack of standardized regulatory policies and concerns for patient privacy are still hindering the widespread adoption of smart wearable technologies in clinical practice. We present several recommendations to navigate these challenges and propose a simple and practical 'ABCD' guide for clinicians, personalized to their specific practice needs, to accelerate the integration of these devices into the clinical workflow for optimal patient care., (© 2021. Springer Nature Limited.)

This collaborative statement from the Digital Health Committee of the Heart Rhythm Society provides everyday clinical scenarios in which wearables may be utilized by patients for cardiovascular health and arrhythmia management. We describe herein the spectrum of wearables that are commercially available for patients, and their benefits, shortcomings and areas for technological improvement. Although wearables for rhythm diagnosis and management have not been examined in large randomized clinical trials, undoubtedly the usage of wearables has quickly escalated in clinical practice. This document is the first of a planned series in which we will update information on wearables as they are revised and released to consumers., (© 2021 Published by Elsevier Inc. on behalf of Heart Rhythm Society.)

[Figure: see text].

Background: We performed a trial to evaluate the efficacy of a blended intervention with personalized health coaching and virtual cardiac rehabilitation to improve medication adherence and risk factors. The trial was terminated early. Here, we describe findings from a root cause analysis and lessons learned., Methods: SmartGUIDE was an open-label, single-center trial that randomized participants with coronary artery disease who were prescribed a statin and/or P2Y12 inhibitor 1:1 to either usual care or the added use of a mobile app with components of cardiac rehabilitation paired with personal virtual coaching. The primary outcome was medication adherence: proportion of days covered (PDC). The planned sample size was 132. We performed a root cause analysis to evaluate processes from study development to closure., Results: During trial conduct, the technology start-up withdrew the intervention. The study was terminated early with 63 participants randomized and data from 26 available for analysis. The median PDC was high in both groups (intervention group 94%, interquartile range [IQR] 88%-96%; control group: 99%, IQR 95%-100%). Root cause analysis identified factors for not achieving trial objectives: key factors that limited enrollment (inclusion criteria, low penetration of compatible smartphones), participant retention or engagement (poor app product, insufficient technology support), and suboptimal choice of a technology partner (technology start-up's inexperience in health care, poor product design, inadequate fundraising)., Conclusion: We identified important and preventable factors leading to trial failure. These factors may be common across digital health trials and may explain prior observations that many such trials are never completed. Careful vetting of technology partners and more pragmatic study designs may prevent these missteps.

Introduction: Cryoballoon ablation (CBA) is an alternative to radiofrequency ablation (RFA) for ablation of atrial fibrillation (AF) and real-world comparisons of this strategy are lacking. As such, we sought to compare patient and periprocedural characteristics and outcomes of CBA versus RFA in the Get With the Guidelines AFIB Registry., Methods: Categorical variables were compared via the χ 2 test and continuous variables were compared via the Wilcoxon rank-sum test. Adjusted analyses were performed using overlap weighting of propensity scores., Results: A total of 5247 (1465 CBA, 3782 RFA) ablation procedures were reported from 33 sites. Those undergoing CBA more often had paroxysmal AF (60.0% vs. 48.8%) and no prior AF ablation (87.5% vs. 73.8%). CHA 2 DS 2 -VASc scores were similar. Among de novo ablations, most ablations involved intracardiac echocardiography and electroanatomic mapping, but both were less common with CBA (87.3% vs. 93.9%, p < .0001, and 87.7% vs. 94.6%, p < .0001, respectively). CBA was associated with shorter procedures (129 vs. 179 min, p < .0001), increased fluoroscopy use (19 vs. 11 min, p < .0001), and similar ablation times (27 vs. 35 min, p = .15). Nonpulmonary vein ablation was common with CBA: roof line 38.6%, floor line 20.4%, cavotricuspid isthmus 27.7%. RFA was associated with more total complications compared to CBA (5.4% vs. 2.3%, p < .0001), due to more volume overload and "other" events, although phrenic nerve injury was more common with CBA (0.9% vs 0.1%, p = .0001). In the adjusted model, any complication was less common among CBA cases (odds ratio, 0.45; confidence interval, 0.25-0.79, p = .0056)., Conclusion: CBA was associated with fewer complications, and shorter procedure times, and greater fluoroscopy times, compared to RFA. Nonpulmonary vein ablation and electroanatomic mapping system use was common with CBA., (© 2020 Wiley Periodicals LLC.)

This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia-Pacific Heart Rhythm Society describes the current status of mobile health technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mobile health. The promises of predictive analytics but also operational challenges in embedding mobile health into routine clinical care are explored.

Background: Antiarrhythmic drug (AAD) therapy for atrial fibrillation (AF) can be associated with both proarrhythmic and noncardiovascular toxicities. Practice guidelines recommend tailored AAD therapy for AF based on patient-specific characteristics, such as coronary artery disease and heart failure, to minimize adverse events. However, current prescription patterns for specific AADs and the degree to which these guidelines are followed in practice are unknown., Methods: Patients enrolled in the Get With The Guidelines-Atrial Fibrillation registry with a primary diagnosis of AF discharged on an AAD between January 2014 and November 2018 were included. We analyzed rates of prescription of each AAD in several subgroups including those without structural heart disease. We classified AAD use as guideline concordant or nonguideline concordant based on 6 criteria derived from the American Heart Association/American College of Cardiology/Heart Rhythm Society AF guidelines. Guideline concordance for amiodarone was not considered applicable, since its use is not specifically contraindicated in the guidelines for reasons such as structural heart disease or renal function. We analyzed guideline-concordant AAD use by specific patient and hospital characteristics, and regional and temporal trends., Results: Among 21 921 patients from 123 sites, the median age was 69 years, 46% female and 51% had paroxysmal AF. The most commonly prescribed AAD was amiodarone (38%). Sotalol (23.2%) and dofetilide (19.2%) were each more commonly prescribed than either flecainide (9.8%) or propafenone (4.8%). Overall guideline-concordant AAD prescription at discharge was 84%. Guideline-concordant AAD use by drug was as follows: dofetilide 93%, sotalol 66%, flecainide 68%, propafenone 48%, and dronedarone 80%. There was variability in rate of guideline-concordant AAD use by hospital and geographic region., Conclusions: Amiodarone remains the most commonly prescribed AAD for AF followed by sotalol and dofetilide. Rates of guideline-concordant AAD use were high, and there was significant variability by specific drugs, hospitals, and regions, highlighting opportunities for additional quality improvement.

Ambulatory monitoring is increasingly important for cardiovascular care but is often limited by the unpredictability of cardiovascular events, the intermittent nature of ambulatory monitors and the variable clinical significance of recorded data in patients. Technological advances in computing have led to the introduction of novel physiological biosignals that can increase the frequency at which abnormalities in cardiovascular parameters can be detected, making expert-level, automated diagnosis a reality. However, use of these biosignals for diagnosis also raises numerous concerns related to accuracy and actionability within clinical guidelines, in addition to medico-legal and ethical issues. Analytical methods such as machine learning can potentially increase the accuracy and improve the actionability of device-based diagnoses. Coupled with interoperability of data to widen access to all stakeholders, seamless connectivity (an internet of things) and maintenance of anonymity, this approach could ultimately facilitate near-real-time diagnosis and therapy. These tools are increasingly recognized by regulatory agencies and professional medical societies, but several technical and ethical issues remain. In this Review, we describe the current state of cardiovascular monitoring along the continuum from biosignal acquisition to the identification of novel biosensors and the development of analytical techniques and ultimately to regulatory and ethical issues. Furthermore, we outline new paradigms for cardiovascular monitoring.

This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored., (© 2020 2666-6936/ All rights reserved. \xA9 2021 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals Inc. on behalf of the International Society for Holter and Noninvasive Electrocardiology / Cardiovascular Digital Health Journal published by Elsevier Inc. on behalf of the Heart Rhythm Society / Circulation: Arrhythmia and Electrophysiology published by Wolters Kluwer Health, Inc. on behalf of the American Heart Association, Inc. / European Heart Journal \x96 Digital Health published by Oxford University Press on behalf of the European Society of Cardiology / Journal of Arrhythmia published by Wiley and Sons Australia Ltd on behalf of the Japanese Heart Rhythm Society and the Asia Pacific Heart Rhythm Society. This article is published under the Creative Commons CC-BY license, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. This is an open access article under the CC BY license.)

Clinically recognized atrial fibrillation (AF) is associated with higher risk of complications, including ischemic stroke, cognitive decline, heart failure, myocardial infarction, and death. It is increasingly recognized that AF frequently is undetected until complications such as stroke or heart failure occur. Hence, the public and clinicians have an intense interest in detecting AF earlier. However, the most appropriate strategies to detect undiagnosed AF (sometimes referred to as subclinical AF) and the prognostic and therapeutic implications of AF detected by screening are uncertain. Our report summarizes the National Heart, Lung, and Blood Institute's virtual workshop focused on identifying key research priorities related to AF screening. Global experts reviewed major knowledge gaps and identified critical research priorities in the following areas: (1) role of opportunistic screening; (2) AF as a risk factor, risk marker, or both; (3) relationship between AF burden detected with long-term monitoring and outcomes/treatments; (4) designs of potential randomized trials of systematic AF screening with clinically relevant outcomes; and (5) role of AF screening after ischemic stroke. Our report aims to inform and catalyze AF screening research that will advance innovative, resource-efficient, and clinically relevant studies in diverse populations to improve the diagnosis, management, and prognosis of patients with undiagnosed AF.

The growing population of older adults (age ≥65 years) is expected to lead to higher rates of cardiovascular disease. The expansion of digital health (encompassing telehealth, telemedicine, mobile health, and remote patient monitoring), Internet access, and cellular technologies provides an opportunity to enhance patient care and improve health outcomes-opportunities that are particularly relevant during the current coronavirus disease-2019 pandemic. Insufficient dexterity, visual impairment, and cognitive dysfunction, found commonly in older adults should be taken into consideration in the development and utilization of existing technologies. If not implemented strategically and appropriately, these can lead to inequities propagating digital divides among older adults, across disease severities and socioeconomic distributions. A systematic approach, therefore, is needed to study and implement digital health strategies in older adults. This review will focus on current knowledge of the benefits, barriers, and use of digital health in older adults for cardiovascular disease management., Competing Interests: Author Disclosures Dr. Dorsch is supported by R18 HS026874 and R21 HS026322 from the Agency for Health Research and Quality, R01 AG062582 from the National Institutes of Health (NIH)/National Institute of Aging, and the American Health Association Health IT Research Network; has received honoraria from Janssen; and has received research funding from Bristol Myers Squibb/Pfizer and Amgen in the past 2 years. Dr. Dodson is supported by K23 AG052463 from the NIH/National Institute of Aging, and R01 AG062520 from the NIH/National Institute of Aging. Dr. Masterson Creber is supported by NIH/National Institute of Nursing Research R00NR016275, and NIH/National Heart, Lung, and Blood Institute R01HL152021. Dr. Kitsiou is supported by the NIH/National Institute of Nursing Research R01NR017635 and R21NR018281, NIH/National Heart, Lung, and Blood Institute R61HL139454, and NIH/National Institute on Aging P30AG022849. Dr. Goyal is supported by the National Institute on Aging (NIA) grant R03AG056446 and American Heart Association grant 18IPA34170185. Dr. Maurer has received grant support from National Institutes of Health R01HL139671-01, R21AG058348, and K24AG036778; has received consulting income from Pfizer, GlaxoSmithKline, EIdos, Prothena, Akcea, and Alnylam; and his institution has received clinical trial funding from Pfizer, Prothena, Eidos, and Alnylam. Dr. Batsis is supported in part by the National Institute on Aging of the National Institutes of Health under Award Number K23AG051681 and R01-AG067416; and has part ownership in a patent developed for the Instrumented Resistance Exercise Device (Dartmouth Patent application # 62/672,827). Dr. Turakhia has received grants unrelated to this work from Apple, Janssen, Bayer, AstraZeneca, Boehringer Ingelheim, the American Heart Association, and Bristol Myers Squibb; has been a consultant to Medtronic, Biotronik, Pfizer, Bayer, Novartis, Sanofi, Johnson & Johnson, Myokardia, and Milestone Pharmaceuticals unrelated to this work; and is an editor for JAMA Cardiology. Dr. Forman is supported by the NIH National Institute on Aging R01AG060499-01, R01AG058883, and P30AG024827, and the NIH Common Fund U01AR071130. Dr. Bernacki is supported by T32HL125195-04 from the NIH/National Heart, Lung, and Blood Institute. Dr. Peterson has received research funding from AstraZeneca, Janssen, Amgen, and Sanofi unrelated to this work. Dr. Freeman does nonpromotional speaking for Boehringer Ingelheim; has served on Advisory Boards for The Medicines Company and Regeneron; and has served as a consultant for Actelion, none of which are related to the work submitted. Dr. Bhavnani has served as a scientific advisor to Analytics 4 Life and Blumio; has served as a consultant to Bristol Myers Squibb and Pfizer; and has received research support from Scripps Clinic, Alliance Healthcare Foundation, and the Qualcomm Foundation outside of the present work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The views expressed in this paper are by members of the American College of Cardiology’s Innovation Council, Cardiovascular Team Council and the Geriatric Cardiology Section Leadership Council and do not necessarily reflect the views of the Journal of the American College of Cardiology or the American College of Cardiology., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)