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Published on: February 8, 2022
Long-Term Trends in Cardiac Erosion After Transcatheter Closure of Atrial Septal Defects With the Amplatzer Septal
Daniel S Levi1, Doff B McElhinney2
1Department of Pediatrics, Mattel Children's Hospital at UCLA, Los Angeles, California, USA.
Insights
Cardiac erosion rates and mortality linked to the Amplatzer Septal Occluder (ASO) for atrial septal defect closure have significantly declined since 2012, indicating improved safety over time.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Outcomes
Background:
- Cardiac erosion following secundum atrial septal defect (ASD) closure with the Amplatzer Septal Occluder (ASO) requires updated assessment.
- Recent updates to ASO Instructions for Use in 2012 and 2018 necessitate re-evaluation of erosion trends.
Purpose of the Study:
- To evaluate the incidence and demographics of ASO device erosion.
- To assess temporal trends in ASO erosion rates since its introduction in 1996.
Main Methods:
- Analysis of all reported cardiac erosions associated with ASO devices implanted between 1996 and 2024.
- Estimation of annual implant numbers based on device sales.
- Calculation of overall and time-dependent erosion rates.
Main Results:
- An overall estimated erosion rate of 0.037% (198 reported erosions) was observed as of March 2025.
- Erosion rates significantly decreased from 1996-2012 to 2013-2024 (0.056% to 0.020%).
- Erosion-related mortality also showed a decreasing trend.
Conclusions:
- ASO erosion rates and associated mortality have significantly decreased since 2012.
- Acknowledges limitations in implant number estimation and erosion ascertainment.
Background:
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.
Methods:
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.
Results:
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 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 < 0.001), as did 3-day, 1-month, 1-year, and 3-year erosion rates (all p < 0.001). The erosion-related mortality rate decreased from 0.0040% to 0.0014% from the early era to the later era (p = 0.061).
Conclusions:
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.
