房颤消融术后并发症报告不足：制造商与用户设施设备经验的比较——FDA数据库与基于自愿邀请的注册研究：POTTER-AF 3研究
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.
作者信息
Tilz Roland R, Pürerfellner Helmut, Kuck Karl-H, Merino José L, Schmidt Vanessa, Vogler Julia, Xiang Kun, Uzunoglu Ekin C, Heeger Christian-H, Tandri Harikrishna, Assis Fabrizio, Steven Daniel, Veltmann Christian, Catanzaro John N, Popescu Sorin S
机构信息
Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.
Ordensklinikum Linz Elisabethinen, Linz, Austria. Electronic address: https://twitter.com/purerfellner.
出版信息
Heart Rhythm. 2025 Jun;22(6):1472-1479. doi: 10.1016/j.hrthm.2024.09.060. Epub 2024 Sep 29.
BACKGROUND
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.
OBJECTIVE
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.
METHODS
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.
RESULTS
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).
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.
背景
制造商与用户设施设备经验（MAUDE）数据库收录了由强制和自愿报告者提交给美国食品药品监督管理局（FDA）的、涉及在美国销售的医疗设备的不良事件医疗设备报告。MAUDE数据库常用于临床研究以报告与设备相关的并发症。关于其有效性的数据稀缺。
目的
我们旨在比较强制的MAUDE数据库（MAUDE组）和基于邀请的POTTER-AF研究（POTTER-AF 1组）在数据质量、程序特征、诊断、治疗和生存方面的情况。
方法
比较2009年8月1日至2019年8月31日期间MAUDE数据库中房颤（AF）消融术后食管瘘的报告与POTTER-AF研究中的报告。
结果
MAUDE组有47例患者报告发生食管瘘，POTTER-AF 1组有81例。MAUDE组中使用射频、冷冻能量或激光能量进行手术的比例分别为66.0%、31.9%和2.1%，POTTER-AF 1组分别为96.3%、2.5%和1.2%。出现症状的中位时间在MAUDE组为21（14，32.5）天，在POTTER-AF 1组为18.0（6.8，22.3）天（P = 0.031）。MAUDE组38.3%的患者报告了诊断方法，POTTER-AF 1组为98.8%；MAUDE组57.4%的患者报告了治疗情况，POTTER-AF 1组为100%；所有患者均报告了结局。在MAUDE组，治疗方式为手术（51.9%）、内镜（37.0%）、联合（3.7%）或保守（7.4%），POTTER-AF 1组分别为43.2%、19.8%、7.4%和29.6%。MAUDE组的总死亡率为76.6%，POTTER-AF 1组为61.7%（P = 0.118）。
结论
在强制的MAUDE数据库中，与基于邀请的研究相比，报告的食管瘘病例较少。MAUDE数据库的数据质量明显较差。
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