Key result
Enhanced KardiaMobile monitoring fails to significantly shorten time to AF diagnosis versus standard monitoring.
Why the study?
Single-time-point screening has limited benefit for often-paroxysmal AF, prompting evaluation of whether the KardiaMobile device during the specialist care waiting period could reduce time-to-diagnosis of arrhythmias.
Does enhanced monitoring with a KardiaMobile device reduce the time-to-diagnosis for atrial fibrillation or other arrhythmias in patients with symptomatic paroxysmal symptoms awaiting specialist consultation?
RCT (n=69)
1:1 block randomization
No
Does enhanced monitoring with a KardiaMobile device reduce the time-to-diagnosis for atrial fibrillation or other arrhythmias in patients with symptomatic paroxysmal symptoms awaiting specialist consultation?
Hazard Ratio: 6.19 (95% CI 1.41–27.24)
p-value: p=0.053
Providing patients with an on-demand, smartphone-based single-lead ECG device (KardiaMobile) significantly reduces the time-to-diagnosis of cardiac arrhythmias during the waiting period for specialist consultation compared to standard Holter monitoring alone.
Does not support KardiaMobile for expediting AF diagnosis in symptomatic patients; leaves open benefit for broader arrhythmia detection.
Abstract Background Atrial fibrillation (AF) is the most common cardiac arrhythmia. Given its often-paroxysmal nature, screening at a single time point, using a 12-lead electrocardiogram (ECG) or a Holter monitor, has limited benefit. The AliveCor KardiaMobile device is a validated ECG recorder that can be used for patient-directed arrhythmia diagnosis and symptom–rhythm correlation. The aim of this study was to evaluate whether using the KardiaMobile device could reduce the time-to-diagnosis, for AF as well as other arrhythmias. We hypothesized that providing patients with a KardiaMobile device during their waiting period for specialist care could reduce the length of time that passes before ECG detection of arrhythmia. Methods Patients were randomized 1:1 to receive either standard monitoring (ECG and a Holter monitor) or enhanced monitoring (ECG, a Holter monitor, and a KardiaMobile device). Patients were instructed to upload ECG recordings if they had cardiac symptoms, so that symptom–rhythm correlation could be achieved. The primary outcome was the time-to-diagnosis for AF. The secondary endpoint was the time-to-diagnosis for any arrhythmias. Results From October 2018 to October 2022, a total of 69 patients were enrolled, and they were followed up to 12 months. Overall, 6 of the 7 patients diagnosed with AF were in the enhanced-monitoring group (P = 0.106). The time-to-diagnosis was not significantly different in the 2 groups (P = 0.053). Overall arrhythmias were diagnosed in 10 patients (29%) in the standard-monitoring arm, compared to 22 patients (63%) in the enhanced-monitoring arm (P = 0.008). The time-to-diagnosis was reduced in the enhanced-monitoring arm (P = 0.010). Conclusions The time-to-diagnosis of any arrhythmia was reduced significantly in patients randomized to receive KardiaMobile device monitoring. Providing patients with a KardiaMobile device may expedite the diagnosis of arrhythmias during the waiting period for specialist care. Clinical Trial Registration NCT04302311.
No takes yet. Share an insight, caveat, or question.
Coxon et al. (2024) conducted an RCT in Symptomatic arrhythmias (n=69). KardiaMobile device monitoring vs. Standard monitoring (12-lead ECG and 24-hour Holter monitor) was evaluated on Time-to-diagnosis for atrial fibrillation (HR 6.19, 95% CI 1.41-27.24, p=0.053).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: