Daily ECG self-monitoring detected supraventricular arrhythmias in 17.9% of patients after PFO closure, compared to 4.3% with a smartwatch and 3.6% with Holter ECG (p=0.160).
Does daily self-monitoring or continuous smartwatch monitoring improve the detection of new-onset AF or SVA compared to standard Holter ECG in adult patients after percutaneous PFO closure?
Preliminary results suggest daily self-monitoring with a personal ECG device may detect more post-procedural supraventricular arrhythmias after PFO closure than standard Holter monitoring, though the difference was not statistically significant in this early sample.
Absolute Event Rate: 0% vs 0%
Abstract Background Patent foramen ovale (PFO) is the space between a well-developed septum primum and a normally formed septum secundum present in approximately 25% of the adult population, associated with an increased risk of embolic events including ischemic stroke (1-2). While percutaneous PFO closure is superior to antiplatelet therapy alone for secondary stroke prevention, the rate of atrial fibrillation (AF) following percutaneous PFO closure is higher than in general population (3-5). Rates of AF after percutaneous PFO closure vary from 5–6% in clinically detected cases to 25–35% when continuous rhythm monitoring is used (6-8). Currently, the actual prevalence of AF and other supraventricular arrhythmias (SVA) among patients after PFO closure is unclear. Purpose We aimed to determine the incidence of SVA using three monitoring methods: daily self-monitoring with a personal ECG device (KardiaMobile 6L), continuous heart rate tracking with a smartwatch, and standard 24-hour Holter ECG during a 6-week follow-up period. Methods The ASPARAGUS study is a prospective, randomized, multicenter trial including adult patients after percutaneous PFO closure, conducted at 5 Polish cardiology departments. Participants are randomized into three groups according to the cardiac rhythm monitoring method: (1) daily monitoring using Kardia Mobile 6L device, (2) continuous monitoring using smartwatch FitBit Sense, and (3) standard 24-hour Holter ECG monitoring performed on the first day, 3 and 6 weeks after the procedure. The total planned sample size is 235 patients. The primary endpoint is the occurrence of new-onset AF or other SVA lasting ≥30 seconds within 6 weeks after the procedure. Results Eighty patients have been enrolled so far (FitBit Sense n = 23, KardiaMobile 6L n = 28, Holter ECG n = 29). The primary endpoint was observed in 7 patients (8.8%), with the highest incidence in the KardiaMobile 6L group (n=5, 17.9%) compared to FitBit Sense (n=1, 4.3%) and Holter ECG (n=1, 3.6%) (p = 0.160). Only 1 arrhythmic event (Kardia Mobile 6L group) was classified as atrial tachycardia, while the remaining 6 cases represented AF. All detected arrhythmias were symptomatic and occurred at a median of 20 days after PFO closure. Conclusions Preliminary results suggest that the incidence of SVA after PFO closure may be higher when daily self-monitoring methods are used compared to standard Holter ECG. Although the difference did not reach statistical significance in the current sample, these findings support the hypothesis that post-procedural SVA is likely underdetected in routine follow-up. Continued enrollment will help clarify the true incidence and temporal pattern of atrial arrhythmias following percutaneous PFO closure.For image description, please refer to the figure legend and surrounding text.
Rolek et al. (Sun,) reported a other. Daily ECG self-monitoring detected supraventricular arrhythmias in 17.9% of patients after PFO closure, compared to 4.3% with a smartwatch and 3.6% with Holter ECG (p=0.160).
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