Identifying High-Risk Obese Individuals Without Diabetes for GLP-1RA Therapy Using Coronary CTA.

Background: The SELECT trial demonstrated that semaglutide reduced major adverse cardiovascular events among individuals with cardiovascular disease (CVD) and overweight/obesity without diabetes. We hypothesized that coronary artery disease (CAD) detected by coronary computed tomography angiography (CCTA) identifies individuals with similar cardiovascular risk.

Objectives: The aim of the study was to evaluate the association between CAD severity by CCTA and cardiovascular outcomes among individuals resembling The SELECT (Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes) trial population but without known CVD.

Comparison of excess mortality between atrial fibrillation, heart failure, myocardial infarction, and stroke: trends over 2000-2022.

Background And Aims: Monitoring trends in mortality of atrial fibrillation (AF) in comparison with other major cardiovascular conditions indirectly gives insights into the relative progress in management. We examined trends in relative survival metrics of AF compared with heart failure (HF), myocardial infarction (MI), and stroke.

Methods: This nationwide cohort study included all individuals newly diagnosed with AF, HF, MI, or stroke between 2000-2021.

Study protocol for a randomized controlled trial to pilot Restore Energy, Activity Can Help (REACH): an mHealth-enabled peer coaching intervention for fatigue in systemic lupus erythematosus.

Background: Fatigue affects up to 90 % of individuals with systemic lupus erythematosus (SLE), significantly impairing quality of life. Despite its impact, fatigue remains difficult to treat due to its multifactorial nature, including behavioral, psychosocial, and pain-related contributors. While physical activity interventions show promise in reducing SLE-related fatigue, they often fail to address these broader factors and are limited by accessibility challenges.

Efficacy of stochastic vibro-tactile stimulation for newborns at risk of neonatal opioid withdrawal syndrome.

Background: Neonatal Opioid Withdrawal Syndrome (NOWS) continues to be a major public health burden. Our objective was to assess the efficacy of a stochastic vibro-tactile stimulation (SVS) mattress in reducing initiation of pharmacotherapy in neonates at risk for NOWS.

Methods: A multicenter, prospective, non-blinded, randomized clinical trial of neonates born ≥ 35 weeks gestation.

Impact of informative censoring on estimation and testing in randomized trials with delayed treatment effects.

Time-to-event endpoints like progression-free survival in oncology randomized trials sometimes demonstrate differential censoring patterns between study arms which can be indicative of informative censoring, depending on censoring reasons. Informative censoring can bias treatment effect estimates but few simulation studies characterized the magnitude of its impact, particularly in the context of therapies with delayed treatment effects. We used copula methods to model dependent censoring data and assessed the impact of informative censoring.

Impact of a clinical atrial fibrillation risk estimation tool on cardiac rhythm monitor utilization following acute ischemic stroke: A prepost clinical trial.

Background: Detection of undiagnosed atrial fibrillation (AF) after ischemic stroke through extended cardiac monitoring is important for preventing recurrent stroke. We evaluated whether a tool that displays clinically predicted AF risk to clinicians caring for stroke patients was associated with the use of extended cardiac monitoring.

Methods: We prospectively included hospitalized ischemic stroke patients without known AF in a preintervention (October 2018 - June 2019) and intervention period (March 11, 2021 - March 10, 2022).

Relationship of Subendocardial Perfusion to Myocardial Injury, Cardiac Structure, and Clinical Outcomes Among Patients With Hypertension.

Background: Coronary microvascular dysfunction has been implicated in the development of hypertensive heart disease and heart failure, with subendocardial ischemia identified as a driver of sustained myocardial injury and fibrosis. We aimed to evaluate the relationships of subendocardial perfusion with cardiac injury, structure, and a composite of major adverse cardiac and cerebrovascular events consisting of death, heart failure hospitalization, myocardial infarction, and stroke.

Methods: Layer-specific blood flow and myocardial flow reserve (MFR; stress/rest myocardial blood flow) were assessed by N-ammonia perfusion positron emission tomography in consecutive patients with hypertension without flow-limiting coronary artery disease (summed stress score <3) imaged at Brigham and Women's Hospital (Boston, MA) from 2015 to 2021.

Social drivers in atrial fibrillation occurrence, screening, treatment, and outcomes: systematic-narrative hybrid review.

The importance of social drivers of health (SDOH) in the occurrence, detection, treatment, and outcome of atrial fibrillation (AF) has attracted increasing attention. Addressing SDOH factors may suggest opportunities to prevent AF and its complications. We aimed to conduct a structured narrative review and summarize current knowledge on the association between race and ethnicity, SDOH, including rural vs.

Agreement Between Apple Watch and Actical Step Counts in a Community Setting: Cross-Sectional Investigation From the Framingham Heart Study.

Background: Step counting is comparable among many research-grade and consumer-grade accelerometers in laboratory settings.

Objective: The purpose of this study was to compare the agreement between Actical and Apple Watch step-counting in a community setting.

Methods: Among Third Generation Framingham Heart Study participants (N=3486), we examined the agreement of step-counting between those who wore a consumer-grade accelerometer (Apple Watch Series 0) and a research-grade accelerometer (Actical) on the same days.

Estimating the Effect of Bariatric Surgery on Cardiovascular Events Using Observational Data?

Background: Observational studies have reported strongly protective effects of bariatric surgery on cardiovascular disease, but with oversimplified definitions of the intervention, eligibility criteria, and follow-up, which deviate from those in a randomized trial. We describe an attempt to estimate the effect of bariatric surgery on cardiovascular disease without introducing these sources of bias, which may not be entirely possible with existing observational data.

Methods: We propose two target trials among persons with diabetes: (1) bariatric operation (vs.

Association of Dynamic Trajectories of Time-Series Data and Life-Threatening Mass Effect in Large Middle Cerebral Artery Stroke.

Background: Life-threatening, space-occupying mass effect due to cerebral edema and/or hemorrhagic transformation is an early complication of patients with middle cerebral artery stroke. Little is known about longitudinal trajectories of laboratory and vital signs leading up to radiographic and clinical deterioration related to this mass effect.

Methods: We curated a retrospective data set of 635 patients with large middle cerebral artery stroke totaling 95,463 data points for 10 longitudinal covariates and 40 time-independent covariates.

MSGene: a multistate model using genetic risk and the electronic health record applied to lifetime risk of coronary artery disease.

Coronary artery disease (CAD) is the leading cause of death among adults worldwide. Accurate risk stratification can support optimal lifetime prevention. Current methods lack the ability to incorporate new information throughout the life course or to combine innate genetic risk factors with acquired lifetime risk.

Association of large core middle cerebral artery stroke and hemorrhagic transformation with hospitalization outcomes.

Historically, investigators have not differentiated between patients with and without hemorrhagic transformation (HT) in large core ischemic stroke at risk for life-threatening mass effect (LTME) from cerebral edema. Our objective was to determine whether LTME occurs faster in those with HT compared to those without. We conducted a two-center retrospective study of patients with ≥ 1/2 MCA territory infarct between 2006 and 2021.

Temporal trends in lifetime risks of atrial fibrillation and its complications between 2000 and 2022: Danish, nationwide, population based cohort study.

Objectives: To examine how the lifetime risks of atrial fibrillation and of complications after atrial fibrillation changed over time.

Design: Danish, nationwide, population based cohort study.

Setting: Population of Denmark from 1 January 2000 to 31 December 2022.

Birth cohort effects on diagnosed atrial fibrillation incidence: nationwide cohort study from 1980 to 2018.

Background: The incidence of atrial fibrillation (AF) shows substantial temporal trends, but the contribution of birth cohort effects is unknown. These effects refer to the relationship between birth year and the likelihood of developing AF. We aimed to assess trends in cumulative incidence of diagnosed AF across birth cohorts and to disentangle the effects of age, birth cohort and calendar period by using age-period-cohort analyses.

Comparative Effectiveness of PET and SPECT MPI for Predicting Cardiovascular Events After Kidney Transplant.

Background: Advanced chronic kidney disease is associated with high cardiovascular risk, even after kidney transplant. Pretransplant cardiac testing may identify patients who require additional assessment before transplant or would benefit from risk optimization. The objective of the current study was to determine the relative prognostic utility of pretransplant positron emission tomography (PET) and single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) for posttransplant major adverse cardiovascular events (MACEs).

Dynamic trajectories of life-threatening mass effect in patients with large middle cerebral artery stroke.

Background: Life-threatening, space-occupying mass effect due to cerebral edema and/or hemorrhagic transformation is an early complication of patients with middle cerebral artery () stroke. Little is known about longitudinal trajectories of laboratory and vital signs leading up to radiographic and clinical deterioration related to this mass effect.

Methods: We curated a granular retrospective dataset of 635 patients with large middle cerebral artery () stroke totaling 108,547 data points for repeated measurements of 10 covariates, and 40 time-independent covariates.

From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials.

Background/objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials.

Methods: The need for clinical research in the context of the COVID-19 pandemic, along with innovations in technology, led us to use a decentralized trial approach in our Phase 2 COVID-19 trial. We used real-time acquisition and transmission of health-related data using home-based monitoring devices and mobile applications to assess outcomes.

MSGene: Derivation and validation of a multistate model for lifetime risk of coronary artery disease using genetic risk and the electronic health record.

Currently, coronary artery disease (CAD) is the leading cause of death among adults worldwide. Accurate risk stratification can support optimal lifetime prevention. We designed a novel and general multistate model (MSGene) to estimate age-specific transitions across 10 cardiometabolic states, dependent on clinical covariates and a CAD polygenic risk score.

Electrical energy by electrode placement for cardioversion of atrial fibrillation: a systematic review and meta-analysis.

Objective: Electrode patch position may not be critical for success when cardioverting atrial fibrillation (AF), but the relevance of applied electrical energy is unclarified. Our objective was to perform a meta-analysis of randomised trials to examine the dose-response relation between energy level and cardioversion success by electrode position in elective cardioversion.

Methods: We searched PubMed, Embase, The Cochrane Library, Google Scholar and Scopus Citations.

The use of N-of-1 trials to generate real-world evidence for optimal treatment of individuals and populations.

Introduction: Ideally, real-world data (RWD) collected to generate real-world evidence (RWE) should lead to impact on the care and health of real-world patients. Deriving from care in which clinicians and patients try various treatments to inform therapeutic decisions, N-of-1 trials bring scientific methods to real-world practice.

Methods: These single-patient crossover trials generate RWD and RWE by giving individual patients various treatments in a double-blinded way in sequential periods to determine the most effective treatment for a given patient.

Extending the vision of adaptive point-of-care platform trials to improve targeted use of drug therapy regimens: An agile approach in the learning healthcare system toolkit.

Objectives: Improving the targeted use of drug regimens requires robust real-world evidence (RWE) to address the uncertainties that remain regarding their real-world performance following market entry. However, challenges in the current state of RWE production limit its impact on clinical decisions, as well as its operational scalability and sustainability. We propose an adaptive point-of-care (APoC) platform trial as an approach to RWE production that improves both clinical and operational efficiencies.