Effect of Implantable vs Prolonged External Electrocardiographic Monitoring on Atrial Fibrillation Detection in Patients With Ischemic Stroke

Abstract

The relative rates of detection of atrial fibrillation (AF) or atrial flutter from evaluating patients with prolonged electrocardiographic monitoring with an external loop recorder or implantable loop recorder after an ischemic stroke are unknown.OBJECTIVE To determine, in patients with a recent ischemic stroke, whether 12 months of implantable loop recorder monitoring detects more occurrences of AF compared with conventional external loop recorder monitoring for 30 days. Investigator-initiated, open-label, randomized clinical trial conducted at 2 university hospitals and 1 community hospital in Alberta, Canada, including 300 patients within 6 months of ischemic stroke and without known AF from May 2015 through November 2017; final follow-up was in December 2018. DESIGN, SETTING, AND PARTICIPANTSINTERVENTIONS Participants were randomly assigned 1:1 to prolonged electrocardiographic monitoring with either an implantable loop recorder (n = 150) or an external loop recorder (n = 150) with follow-up visits at 30 days, 6 months, and 12 months. MAIN OUTCOMES AND MEASURESThe primary outcome was the development of definite AF or highly probable AF (adjudicated new AF lasting Ն2 minutes within 12 months of randomization). There were 8 prespecified secondary outcomes including time to event analysis of new AF, recurrent ischemic stroke, intracerebral hemorrhage, death, and device-related serious adverse events within 12 months. RESULTS Among the 300 patients who were randomized (median age, 64.1 years [interquartile range, 56.1 to 73.7 years]; 121 were women [40.3%]; and 66.3% had a stroke of undetermined etiology with a median CHA 2 DS 2 -VASc [congestive heart failure, hypertension, age Ն75 years, diabetes, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category] score of 4 [interquartile range, 3 to 5]), 273 (91.0%) completed cardiac monitoring lasting 24 hours or longer and 259 (86.3%) completed both the assigned monitoring and 12-month follow-up visit. The primary outcome was observed in 15.3% (23/150) of patients in the implantable loop recorder group and 4.7% (7/150) of patients in the external loop recorder group (between-group difference, 10.7% [95% CI, 4.0% to 17.3%]; risk ratio, 3.29 [95% CI, 1.45 to 7.42]; P = .003). Of the 8 specified secondary outcomes, 6 were not significantly different. There were 5 patients (3.3%) in the implantable loop recorder group who had recurrent ischemic stroke vs 8 patients (5.3%) in the external loop recorder group (between-group difference, −2.0% [95% CI, −6.6% to 2.6%]), 1 (0.7%) vs 1 (0.7%), respectively, who had intracerebral hemorrhage (between-group difference, 0% [95% CI, −1.8% to 1.8%]), 3 (2.0%) vs 3 (2.0%) who died (between-group difference, 0% [95% CI, −3.2% to 3.2%]), and 1 (0.7%) vs 0 (0%) who had device-related serious adverse events.CONCLUSIONS AND RELEVANCE Among patients with ischemic stroke and no prior evidence of AF, implantable electrocardiographic monitoring for 12 months, compared with prolonged external monitoring for 30 da...

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).…”

“…One RCT was excluded in Fig. 2C due to offering insufficient data of the time to first detection of AF within 12 months [20].…”

Neurologist-Led Management of Implantable Loop-Recorders After Embolic Stroke of Undetermined Source

“…Implantable loop-recorder (ILR) is considered safe and provides excellent long-term observation due to automatic reporting with little discomfort to the patients. It is superior to long-term wearable monitors in the detection of AFib in non-cardioembolic stroke (7). Previous studies showed AFib detection after long-term observation in up to 30% of patients after cryptogenic stroke (8)(9)(10)(11).…”

Fatigue Testing of Wearable Sensing Technologies: Issues and Opportunities

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