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

Abstract

IMPORTANCEPatients 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 PARTICIPANTSThe 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 MEASURESIncident 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) CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age Ն75 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.

Differences between Atrial Fibrillation Detected before and after Stroke and TIA: A Systematic Review and Meta-Analysis

“…Other AFDAS may also be preexistent but not causally associated with the stroke and incidentally diagnosed on prolonged cardiac monitoring in patients with a competing embolic (e.g., carotid artery disease) or atherothrombotic (e.g., small vessel disease) mechanisms. The Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE AF) study, where AFDAS was found in 12.4% of patients with noncardioembolic events at 12 months, supports that AFDAS may not always have a causal role [12]. Regardless of the lack of a causal association between some AFDAS and the related stroke, these arrhythmias may still bear a high risk of stroke that requires close follow-up and optimized medical management.…”

The efficacy and safety of insertable cardiac monitor on atrial fibrillation detection in patients with ischemic stroke: a systematic review and meta-analysis

“…Of these, a total of 710 articles were excluded due to duplication and irrelevance and 119 full articles were further assessed for eligibility; subsequently, 116 articles, including 28 non-randomized clinical trials, seven case reports, five meta-analyses, and 76 reviews. Eventually, three RCTs [18][19][20] containing 1233 patients (613 in the ICM group and 620 placebo group) were selected for qualitative synthesis (Fig. 1).…”

Amulet™ Shines and Protects; Pacing Battle Intensifies with “More Leads or No Leads”?

“…Post-hoc analysis showed that 67% of patients with detected AF were started on anticoagulation and that placement of an implantable cardiac monitor was associated with a non-significant reduction in recurrent ischemic or hemorrhagic stroke. 20 Further work is still needed to elucidate the pathophysiologic role of AF and stroke. AF is clearly associated with an increased risk of stroke; however, every study has been confounded by the shared risk factors of the CHA 2 DS 2 -VASc score that predispose to both stroke and AF.…”