Arrhythmias & electrophysiology
Underreporting of complications following atrial fibrillation (AF) ablation: Comparison of the manufacturer and user facility device experience Food and Drug Administration (FDA) database and a voluntary invitation-based registry: The POTTER-AF 3 study
Authors' conclusion
In the mandatory MAUDE database, fewer esophageal fistula cases were reported compared with an invitation-based study. The data quality in the MAUDE database was significantly poorer.
Study context
- Population
- Patients with esophageal fistula following AF ablation, August 1, 2009 to August 31, 2019
- Participants
- 47 vs 81
- Exposure
- MAUDE database vs invitation-based POTTER-AF registry
- MAUDEn = 47
- POTTER-AF 1n = 81reference
- Outcome
- Esophageal fistula reports and data quality
Main finding
As reported in the abstract
Diagnostic method reported
Treatment reported
Observational data: associations, not effects.
Further findings
Ablation energy (radiofrequency, cryoenergy, laser)
Radiofrequency
Cryoenergy
Laser
Treatment (surgical, endoscopic, combined, conservative)
Surgical
Endoscopic
Combined
Conservative
Overall mortality
P = 0.118
Time to symptoms
P = 0.031
Original publication
Underreporting of complications following AF ablation: Comparison of the manufacturer and user facility device experience FDA database and a voluntary invitation-based registry: The POTTER-AF 3 study. Heart Rhythm. Published 29 September 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →