Key result
MAUDE database captures fewer post-AF ablation esophageal fistulas with poorer data quality than POTTER-AF.
Why the study?
Does the mandatory MAUDE database differ from the voluntary POTTER-AF registry in reporting data quality and outcomes for esophageal fistula following AF ablation?
Observational (n=128)
Yes
Does the mandatory MAUDE database differ from the voluntary POTTER-AF registry in reporting data quality and outcomes for esophageal fistula following AF ablation?
Absolute Event Rate: 76.6% vs 61.7%
p-value: p=0.118
The FDA MAUDE database significantly underreports severe complications like esophageal fistula following AF ablation and suffers from poorer data quality compared to a dedicated voluntary registry.
The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports of adverse events involving medical devices marketed in the United States submitted to the U.S. Food and Drug Administration (FDA) by mandatory and voluntary reporters. The MAUDE database is frequently used in clinical studies to report on device-related complications. Data about its efficacy are scarce. We aimed to compare the mandatory MAUDE database (MAUDE group) with the invitation-based POTTER-AF study (POTTER-AF 1 group) regarding data quality, procedural characteristics, diagnosis, treatment, and survival. The reports of esophageal fistula esophageal fistula following atrial fibrillation (AF) ablation in the MAUDE database were compared with those in the POTTER-AF study between August 1, 2009, and August 31, 2019. Esophageal fistulas were reported in 47 patients in the MAUDE group and in 81 in the POTTER-AF 1 group. Procedures were performed with radiofrequency, cryoenergy, or laser energy in 66.0%, 31.9%, and 2.1% (MAUDE group) and in 96.3%, 2.5%, and 1.2% (POTTER-AF 1 group). The median time to symptoms was 21 (14, 32.5) days (MAUDE group) and 18.0 (6.8, 22.3) days (POTTER-AF 1 group; P = .031). The diagnostic method was reported in 38.3% of patients in the MAUDE group and in 98.8% in the POTTER-AF 1 group, the treatment in 57.4% and 100%, and the outcome in all patients. In the MAUDE group, treatment was surgical (51.9%), endoscopic (37.0%), combined (3.7%), or conservative (7.4%), compared with 43.2%, 19.8%, 7.4%, and 29.6% in the POTTER-AF 1 group. Overall mortality was 76.6% in the MAUDE group and 61.7% in the POTTER-AF 1 group (P = .118). 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.
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Tilz et al. (2024) conducted an observational in Esophageal fistula following atrial fibrillation ablation (n=128). MAUDE database vs. POTTER-AF study was evaluated on Overall mortality (p=0.118). The mandatory MAUDE database reported fewer cases of esophageal fistula following AF ablation and poorer data quality than the POTTER-AF registry, with reported mortality of 76.6% vs 61.7% (P=0.118).
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