Long-Term Trends in Cardiac Erosion After Transcatheter Closure of Atrial Septal Defects With the Amplatzer Septal Occluder.

内容摘要

Trends in cardiac erosion after closure of secundum atrial septal defects (ASD) with the Amplatzer Septal Occluder (ASO) have not been assessed since updates were made to the Instructions for Use in 2012 and 2018. This study evaluates the incidence and demographics of ASO erosion over time since its introduction in 1996. Data were analyzed for all cardiac erosions reported through March 2025 after ASD closure with an ASO device from 1996 to 2024, as adjudicated and characterized by the AGA Erosion Board or Abbott Medical Affairs. The number of implants annually was estimated as the number of units sold in the calendar year. Overall and time-dependent erosion rates were calculated as the ratio of reported erosions to the estimated number of implants during each calendar year. As of March 2025, 198 erosions had been reported and confirmed for ASO devices implanted from 1996 through 2024, which corresponds to an estimated erosion rate of 0.037%. Overall, 31% of erosions occurred within 72&#x2009;h of implant, 55% within 3 months, and 77% within 1 year, while 13% occurred >5 years after implant. The 1-month, 1-year, and 3-year erosion rates were 0.016%, 0.029%, and 0.031%, respectively. The overall erosion rate decreased significantly from 1996 to 2012 to 2013 to 2024 (0.056% to 0.020%, p&#x2009;<&#x2009;0.001), as did 3-day, 1-month, 1-year, and 3-year erosion rates (all p&#x2009;<&#x2009;0.001). The erosion-related mortality rate decreased from 0.0040% to 0.0014% from the early era to the later era (p&#x2009;=&#x2009;0.061). Although limitations in the method of estimating implant numbers and ascertaining erosions must be acknowledged, ASO erosion rates and related mortality have decreased significantly since 2012.