Arrhythmias & electrophysiology

Performance of Single-Lead Handheld Electrocardiograms for Atrial Fibrillation Screening in Primary Care: The VITAL-AF Trial

JACC AdvPublished Diagnostic accuracy study

Authors' conclusion

In an older primary care population undergoing AF screening with handheld 1L ECGs, automated algorithm interpretations were sufficiently accurate to exclude the presence of AF but not to establish an AF diagnosis.

Study context

Population
Individuals aged ≥65 years in population-based atrial fibrillation (AF) screening within routine primary care (VITAL-AF trial)31,376 tracings
Participants
14,230 individuals
Comparison
AliveCor KardiaMobile 1L ECG algorithm vs cardiologist overread
Outcome
Diagnostic test characteristics of 1L ECG automated interpretations for AF
Methodological detailsprospective, embedded in the VITAL-AF trial, unblinded cardiologist overread as gold standard, 31,376 tracings reviewed by 13 cardiologists; single 30s tracings administered by medical assistants
  • Prospective
  • Embedded in the VITAL-AF trial
  • Unblinded cardiologist overread as gold standard
  • 31,376 tracings reviewed by 13 cardiologists; single 30s tracings administered by medical assistants

Performance

As reported in the abstract

AF detection
Test or modelSensitivitySpecificityPPV (possible AF)NPV (normal)
AliveCor algorithm51.0% (95% CI: 47.1%-54.9%)98.7% (95% CI: 98.6%-98.9%)51.7% (95% CI: 47.8%-55.6%)99.8% (95% CI: 99.7%-99.8%)

AliveCor algorithm

Sensitivity51.0% (95% CI: 47.1%-54.9%)
Specificity98.7% (95% CI: 98.6%-98.9%)
PPV (possible AF)51.7% (95% CI: 47.8%-55.6%)
NPV (normal)99.8% (95% CI: 99.7%-99.8%)

Further findings

AliveCor interpretation categories

Normal
24,906 (79.6%)
Unclassified
5,046 (16.1%)
Possible AF
797 (2.5%)
No analysis
573 (1.8%)

PPV for AF of unclassified and no-analysis tracings

Unclassified PPV
5.9% (95% CI: 5.1%-6.7%)
No analysis PPV
6.5% (95% CI: 4.6%-8.9%)
Unclassified/no analysis prevalence by age, 65-69 vs ≥85 years
13.7% to 28.1%, P < 0.01

Original publication

Performance of Single-Lead Handheld Electrocardiograms for Atrial Fibrillation Screening in Primary Care: The VITAL-AF Trial. JACC Adv. Published 20 September 2023. doi:10.1016/j.jacadv.2023.100616

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