Key result
ILR monitoring in ESUS is linked to ~59% lower risk of death, stroke, or TIA.
Why the study?
Atrial fibrillation is the most important cause of ESUS, and this registry was created to confirm its prevalence after ESUS and evaluate the clinical benefits of ILR monitoring on TIA/stroke recurrence and death.
Does implantable loop recorder monitoring improve clinical outcomes such as TIA/stroke recurrence and death in patients with embolic stroke of undetermined source?
Cohort (n=264)
No
Does implantable loop recorder monitoring improve clinical outcomes such as TIA/stroke recurrence and death in patients with embolic stroke of undetermined source?
Effect estimate: OR 0.41 (95% CI 0.19-0.87)
Absolute Event Rate: 11% vs 20.5%
p-value: p=0.02
In patients with embolic stroke of undetermined source, implantable loop recorders not only increased atrial fibrillation detection but were also associated with a significant reduction in mortality and recurrent ischemic events.
ILR monitoring was associated with lower composite events in ESUS; hypothesis-generating and requires RCT confirmation before practice change.
BACKGROUND AND AIMS: Atrial fibrillation (AF) is the most important cause of embolic stroke of undetermined source (ESUS). Implantable loop recorder (ILR) demonstrated the highest sensitivity for detecting it. This register was created to confirm the high prevalence of AF in patients after ESUS and to verify possible benefits on clinical outcomes such as TIA (Transient Ischaemic Attack)/stroke recurrence and death using ILR. METHODS: A total of 278 patients admitted to "Molinette" Hospital in Stroke Unit department between 2011 and 2016, diagnosed with ESUS, underwent ILR implantation if they had at least one risk factor for AF. A total of 165 patients admitted to other departments in the same center for the same pathology, without ILR, represent the control group. We used propensity score to select 132 patients from each group (matching age, sex, CHADS-VASC, and HAS-BLEED baseline characteristics). RESULTS: The detection rate of AF episodes was significantly higher in the ILR group (p < 0.001). No significant protective role of ILR for clinical endpoints was found on univariate analysis, although a trend towards significance has been pointed for the composite outcome of death and ischemic events recurrence (OR 0.52, CI 0.26-1.04, p = 0.06). A protective role of ILR was found for deaths (OR 0.4, CI 0.17-0.94, p 0.03) and for the composite outcome (OR 0.41, CI 0.19-0.87, p 0.02) on multivariate analysis in the best subsets. CONCLUSION: With our statistical models, we identified a significant clinical benefit from ILR monitoring, evidenced by a trend of less death and TIA/stroke recurrence and relevant ILR protection for prediction of TIA/stroke recurrence.
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Gambino et al. (2022) conducted a cohort in Embolic Stroke of Undetermined Source (ESUS) (n=264). Implantable loop recorder (ILR) vs. Standard care (no ILR) was evaluated on Composite of recurrent stroke or TIA and death (OR 0.41, 95% CI 0.19-0.87, p=0.02). Implantable loop recorder monitoring in patients with embolic stroke of undetermined source and atrial fibrillation risk factors significantly reduced the composite risk of death and recurrent stroke or TIA (OR 0.41).
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