Comparing rates of atrioesophageal fistula with contact force-sensing and non-contact force-sensing catheters: analysis of post-market safety surveillance data

Figures

• 

  Fig. 1. Approach to complaint rate calculations. A healthcare professional or medical device field representative who gains knowledge about an adverse event may report it directly to the manufacturer (solid line). The manufacturer then investigates the complaint and reports to the FDA if it meets reporting criteria set by the FDA. Alternatively, the healthcare professional may decide to report the event directly to the FDA (dashed line), which will relay the complaint to the manufacturer. Thus, for adverse events that meet the FDA criteria of reportability, the MAUDE and Manufacturer databases will contain the same events. In this analysis, the rates of adverse events for each functional family of catheters were normalized to the respective sales volume

• 

  Fig. 2. Analysis of complaint and sales data. a, b Functional families of catheters comprising the CF (blue) and the non-CF (orange) groups in this study and the pooled incidence (percent of sales) of AEF in cases involving these catheters. There was no difference in the AEF rate between the two groups (M-W test, p = 0.69). b Bar plot summarizing the data in a

• 

  Fig. 3. Temporal trends in CF/non-CF AEF incidence and usage. Main panel: Incidence of AEF with CF and non-CF catheters presented over time. Labels indicate the dates of commercial introduction: 1, THERMOCOOL SMARTTOUCH® in the EU; 2, THERMOCOOL SMARTTOUCH® SF in the EU and THERMOCOOL SMARTTOUCH® in the USA; 3, THERMOCOOL SMARTTOUCH® SF in the USA. The trend suggests a greater awareness of AEF coupled with a robust learning curve in the use of these devices. Inset: Rates of usage of CF and non-CF catheters in LA procedures. Since during 2015–2017 CF catheters were used in the vast majority of LA procedures, a direct statistical comparison between the datasets for these years will be inadequate