Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study.

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.

Contemporary trends in cardiac electrophysiology procedures in the United States, and impact of a global pandemic.

Background: There are limited data on trends in nationwide cardiac electrophysiology (EP) procedures in the United States before and during the global COVID-19 pandemic. Objective: We aimed to understand contemporary EP procedural trends and how the COVID-19 pandemic impacted them. Methods: Trends were obtained from publicly reported Centers for Medicare and Medicaid Services data from 2013 to 2020 (latest available). Rates of catheter-based EP procedures (EP studies and ablations) and cardiac implantable electronic device (CIED) procedures were analyzed. All procedural rates were calculated per 100,000 Medicare beneficiaries (year specific). Procedure physician subspecialty was also reported. Results: From 2013 to 2019, annual rate of all cardiac EP procedures increased from 817.91 to 1089.68 per 100,000 beneficiaries. Catheter-based EP procedures increased from 323.73 to 675.01, while CIED rates decreased from 494.18 to 414.67. While all ablation procedures increased over time, relative proportion of ablation procedures being pulmonary vein isolation (PVI) increased (9.9% of ablations in 2013, to 18.2% in 2019). In 2020, rates of both catheter-based EP procedures and CIED procedures decreased; however, PVI share of ablation continued to increase in 2020 comprising 25.2% of ablation procedures. Conclusion: Rates of EP procedures have increased among Medicare beneficiaries, with catheter-based procedures now eclipsing CIEDs. Additionally, a greater proportion of catheter-based EP procedures are PVI, but they still represent a minority of all ablations. In 2020, rates of EP procedures were attenuated, yet the proportion of PVI ablations increased to over one-fourth of ablation procedures. These data have important implications for the EP workforce.