Long‐Term Trends in Cardiac Erosion After Transcatheter Closure of Atrial Septal Defects With the Amplatzer Septal Occluder
Key result
Modern-era Amplatzer Septal Occluder use is linked to ~64% lower post-implant erosion rates.
- P<0.001
- n=500,000
Why the study?
Trends in cardiac erosion after secundum ASD closure with the Amplatzer Septal Occluder had not been evaluated since Instructions for Use were updated in 2012 and 2018.
Does the era of implantation (post-2012 IFU updates) reduce the rate of cardiac erosion in patients receiving the Amplatzer Septal Occluder for ASD closure?
Population
Reported cardiac erosions after ASO ASD closure from 1996 to 2024
Comparison
Implantation era 1996 to 2012 vs 2013 to 2024
Design
Retrospective surveillance and registry-based trend analysis
Authors
Discussion
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Member takes
Implication
Supports refined ASD patient selection for ASO; leaves open whether IFU revisions directly reduced erosions.
Key Points
- To assess long-term incidence, timing, and demographic trends in cardiac erosion following secundum atrial septal defect closure with the Amplatzer Septal Occluder since its 1996 introduction and subsequent Instructions for Use updates.
- Analyzed all cardiac erosions reported through March 2025 following Amplatzer Septal Occluder (ASO) implantation from 1996 through 2024, adjudicated by the AGA Erosion Board or Abbott Medical Affairs.
- Estimated annual implant volumes using worldwide device sales data (>500,000 implants worldwide) to calculate overall and time-dependent erosion rates.
- A total of 198 confirmed erosions occurred among devices implanted from 1996 through 2024, corresponding to an estimated overall erosion rate of 0.037%.
- The overall erosion rate decreased significantly from 0.056% in 1996–2012 to 0.020% in 2013–2024 (p < 0.001), with concurrent significant decreases in 3-day, 1-month, 1-year, and 3-year erosion rates (all p < 0.001).
- Erosions presented within 72 hours in 31% of cases, within 1 year in 77%, and after >5 years in 13%; the erosion-related mortality rate decreased from 0.0040% to 0.0014% between eras (p = 0.061).
Study Design
Type
Observational (n=500,000)
Multicenter
Yes
Structured PICO
Does the era of implantation (post-2012 IFU updates) reduce the rate of cardiac erosion in patients receiving the Amplatzer Septal Occluder for ASD closure?
P
Population
Estimated >500,000 patients worldwide who underwent transcatheter closure of secundum atrial septal defects with the Amplatzer Septal Occluder between 1996 and 2024.
E
Exposure
Amplatzer Septal Occluder (ASO) implantation in the later era (2013-2024)
C
Comparator
Amplatzer Septal Occluder (ASO) implantation in the earlier era (1996-2012)
O
Outcome
Overall erosion rate (ratio of reported erosions to estimated number of implants)safety
Main Result
Absolute Event Rate: 0.02% vs 0.056%
p-value: p=<0.001
Cardiac erosion rates after ASO implantation have significantly decreased since 2012, likely reflecting changes in physician practice and patient selection following updated instructions for use.
Limitations
- Use of device sales as a surrogate for implant frequency
- Potential underreporting and ascertainment bias of erosion events
- Lack of patient-level anatomic and sizing data in patients without reported erosion
Cite This Study
Levi et al. (2026) conducted an observational in Secundum atrial septal defect (n=500,000). Amplatzer Septal Occluder (ASO) implantation (2013-2024 era) vs. Amplatzer Septal Occluder (ASO) implantation (1996-2012 era) was evaluated on Overall erosion rate (p=<0.001). The overall erosion rate after Amplatzer Septal Occluder implantation decreased significantly from 0.056% in the 1996-2012 era to 0.020% in the 2013-2024 era (p < 0.001).