Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: The STROKE-AF Randomized Clinical Trial.

Importance: Patients with ischemic stroke attributed to large- or small-vessel disease are not considered at high risk for atrial fibrillation (AF), and the AF incidence rate in this population is unknown. Objectives: To determine whether long-term cardiac monitoring is more effective than usual care for AF detection in patients with stroke attributed to large- or small-vessel disease through 12 months of follow-up. Design, Setting, and Participants: The STROKE-AF trial was a randomized (1:1), multicenter (33 sites in the US) clinical trial that enrolled 496 patients between April 2016 and July 2019, with primary end point follow-up through August 2020. Eligible patients were aged 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor and had an index stroke attributed to large- or small-vessel disease within 10 days prior to insertable cardiac monitor (ICM) insertion. Interventions: Patients randomized to the intervention group (n = 242) received ICM insertion within 10 days of the index stroke; patients in the control group (n = 250) received site-specific usual care consisting of external cardiac monitoring, such as 12-lead electrocardiograms, Holter monitoring, telemetry, or event recorders. Main Outcomes and Measures: Incident AF lasting more than 30 seconds through 12 months. Results: Among 492 patients who were randomized (mean [SD] age, 67.1 [9.4] years; 185 [37.6%] women), 417 (84.8%) completed 12 months of follow-up. The median (interquartile range) CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score was 5 (4-6). AF detection at 12 months was significantly higher in the ICM group vs the control group (27 patients [12.1%] vs 4 patients [1.8%]; hazard ratio, 7.4 [95% CI, 2.6-21.3]; P < .001). Among the 221 patients in the ICM group who received an ICM, 4 (1.8%) had ICM procedure-related adverse events (1 site infection, 2 incision site hemorrhages, and 1 implant site pain). Conclusions and Relevance: Among patients with stroke attributed to large- or small-vessel disease, monitoring with an ICM compared with usual care detected significantly more AF over 12 months. However, further research is needed to understand whether identifying AF in these patients is of clinical importance. Trial Registration: ClinicalTrials.gov Identifier: NCT02700945.

Success of pacemaker remote monitoring using app-based technology: Does patient age matter?

BACKGROUND: Remote monitoring (RM) improves patient outcomes. App-based RM is a novel technology that enables transmission of implantable device data using smart devices. Limited data exist on the impact of age and sex on the use of app-based RM. OBJECTIVE: To examine the impact of age and sex on the proportion of pacemaker patients who activated app-based RM, time from order to activation, and patient follow-up transmission adherence per guidelines. METHODS: A retrospective analysis was performed using deidentified data from U.S. pacemaker patients enrolled in the Medtronic CareLink database with an app-based monitor (MyCareLink Smart™). Activation was defined as first RM transmission and was considered early if it occurred < 90 days from order. Adherence analysis was limited to patients with ≥12 months' follow-up from activation and excluded transmissions < 90 days from activation. RESULTS: Of 48,016 patients assigned app-based RM, 40,511 (84.4%) activated their device; of these, 31,640 (65.9%) activated their device early. Among 14,232 activated patients (with 12 months' follow-up), 12,743 (89.5%) were considered adherent to guidelines by transmitting at least once more within 3-12 months following their activation transmission. While there were statistical differences in activation, early activation, and adherence among age and sex groups due to large sample sizes, the differences were not clinically significant and the majority of older patients were able to successfully use app-based RM. CONCLUSIONS: Most patients in this large and first-of-its kind reported cohort used smart devices to successfully activate app-based RM technology and remained adherent per guidelines irrespective of age or sex.

A Patient-Centered Intervention Reduces Disparities in Remote Monitoring in Patients With Implanted Cardiac Devices.

BACKGROUND: Remote monitoring (RM) is recommended for patients with cardiovascular implantable electronic devices, yet many individuals, especially those living in underserved communities, fail to receive this guideline-directed care. Multilevel interventions that target patient and clinic-level barriers to RM care may be beneficial. OBJECTIVES: This study sought to evaluate a remotely delivered, patient-centered intervention to improve RM activation and adherence and reduce disparities in RM care. METHODS: The intervention provides home delivery of remote monitor, phone-based education, monitor setup, and facilitation of first transmission. A retrospective cohort analysis was performed using RM data from 190,643 patients (71.6 ± 12.7 years of age, 40.5% female) implanted with a pacemaker or defibrillator at 4,195 U.S. clinics between October 2015 and October 2019. Outcomes included RM activation (12 weeks and 1-year postimplantation) and adherence to clinic-scheduled transmissions. Patients receiving a cardiovascular implantable electronic deviceimplant 0 to 730 days before (control group, n = 95,861) and after (intervention group, n = 94,782) intervention launch were compared using logistic regression and generalized estimating equations. Multivariable models included patient, clinic, and neighborhood socioeconomic characteristics. RESULTS: The odds of achieving guideline-recommended activation were significantly higher in the intervention group at 12 weeks (OR: 2.99; 76.7% vs 60.9%; P < 0.001) and 1 year (OR: 3.05; 88.2% vs 79.3%; P < 0.001). Adherence to scheduled transmissions was also higher in the intervention group compared with the control group (OR: 2.18; 89.1% vs 81.9%; P < 0.001). Preintervention disparities in RM activation and adherence were reduced in underserved groups following the intervention. CONCLUSIONS: A remotely delivered patient-centered intervention was associated with earlier activation and improved adherence to RM while reducing disparities in RM care.