What is the clinical evidence from this study?

Study design: Observational. Population: Atrial fibrillation (n=30). Intervention: PulseOn Arrhythmia Monitor System (wrist-worn PPG and ECG) vs. Three-channel Holter ECG. Primary outcome: Sensitivity and specificity of PPG-based atrial fibrillation detection in 5-min windows.

What does this research mean for the field?

A wrist-worn monitoring system combining continuous photoplethysmography and intermittent ECG can reliably detect atrial fibrillation in outpatients, achieving 95.6% sensitivity and 99.2% specificity with PPG compared to a reference Holter ECG. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

February 9, 2023Open Access

Wrist-worn device combining PPG and ECG can be reliably used for atrial fibrillation detection in an outpatient setting

Key Result

The PulseOn Arrhythmia Monitor System detected atrial fibrillation with 95.6% sensitivity and 99.2% specificity using continuous photoplethysmography compared to a reference Holter ECG.

Study Design

Type

Observational (n=30)

Blinding

Blinded assessors

Multicenter

Structured PICO

Does a wrist-worn device combining continuous PPG and intermittent ECG accurately detect atrial fibrillation in adult outpatients compared to Holter monitoring?

Population

30 adult patients with a prior diagnosis of atrial fibrillation (AF) alone or AF with concomitant atrial flutter, median age 65, 27% female, based in Finland. Patients with pacemakers were excluded.

Intervention

PulseOn Arrhythmia Monitor System (wrist-worn device combining continuous photoplethysmogram [PPG] and intermittent 30-s Lead I electrocardiogram [ECG]) worn continuously for 48 hours.

Comparator

Simultaneous continuous three-channel Holter ECG monitoring for 48 hours (reference standard).

Outcome

Sensitivity and specificity of the PPG-based arrhythmia detection algorithm in detecting atrial fibrillation when analyzed in 5-minute windows.surrogate

A wrist-worn device combining continuous PPG and intermittent ECG demonstrated high sensitivity and specificity for detecting atrial fibrillation in outpatients, though nearly half of continuous PPG data was unanalyzable due to motion artifacts.

Main Result

Absolute Event Rate: 95.6% vs 99.2%

Limitations

Only subjects with a prior diagnosis of atrial fibrillation or atrial flutter were included.
The sample size was limited to 30 subjects.
The standard ECG recording obtained with wrist devices is equivalent to ECG Lead I, which is sub-optimal for the detection of P-waves and flutter waves.
46% of the 5-minute PPG segments were rejected by the algorithm due to inadequate data quality, mostly during daytime activities.

Abstract

Aims: The aim was to validate the performance of a monitoring system consisting of a wrist-worn device and a data management cloud service intended to be used by medical professionals in detecting atrial fibrillation (AF). Methods: Thirty adult patients diagnosed with AF alone or AF with concomitant flutter were recruited. Continuous photoplethysmogram (PPG) and intermittent 30 s Lead I electrocardiogram (ECG) recordings were collected over 48 h. The ECG was measured four times a day at prescheduled times, when notified due to irregular rhythm detected by PPG, and when self-initiated based on symptoms. Three-channel Holter ECG was used as the reference. Results: The subjects recorded a total of 1,415 h of continuous PPG data and 3.8 h of intermittent ECG data over the study period. The PPG data were analyzed by the system's algorithm in 5-min segments. The segments containing adequate amounts, at least ~30 s, of adequate quality PPG data for rhythm assessment algorithm, were included. After rejecting 46% of the 5-min segments, the remaining data were compared with annotated Holter ECG yielding AF detection sensitivity and specificity of 95.6 and 99.2%, respectively. The ECG analysis algorithm labeled 10% of the 30-s ECG records as inadequate quality and these were excluded from the analysis. The ECG AF detection sensitivity and specificity were 97.7 and 89.8%, respectively. The usability of the system was found to be good by both the study subjects and the participating cardiologists. Conclusion: : ClinicalTrials.gov/, NCT05008601.

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