Residual Shunt at 6 Months Follow‐up After Percutaneous Patent Foramen Ovale Closure in CAHAL: A Comparison of Occlutech and Amplatzer

BACKGROUND: Residual shunt is a known complication in percutaneous patent foramen ovale (PFO) closure, and moderate to large residual shunt has been associated with an increased risk of recurrent stroke. Device-related factors, such as device size, have been associated with residual shunt, but comparative data per device type are scarce. AIMS: We compared the prevalence of moderate to large residual shunt at 6 months between the Amplatzer and Occlutech devices. METHODS: In this retrospective cohort study, patients undergoing successful percutaneous PFO closure with an Amplatzer or Occlutech dedicated closure device within the CAHAL centers Amsterdam UMC and Leiden UMC between 2018 and 2024 were included. The study population was divided into patients treated with an Occlutech and an Amplatzer device. The prevalence of moderate/large residual shunt at 6 months of follow-up was compared between the two groups. As a sensitivity analysis, a logistic regression was conducted to determine the association between the treatment groups and moderate/large residual shunt. The logistic regression was conducted in a weighted population using inverse probability weighting (IPTW), correcting for age, sex, smoking status, shunt size at baseline, device size, and atrial septal aneurysm. RESULTS: A total of 413 patients were included with an average age of 45.8 ± 11.3 years and 51.6% were male. Of the included patients, 279 were treated with an Amplatzer- and 134 with an Occlutech device. In the group treated with an Amplatzer, 22.2% of the patients had a moderate or large residual shunt at 6 months compared to 14.9% in the Occlutech group (p = 0.11). The sensitivity analysis did not show an association between device type and moderate/large shunt OR 0.71 (95% CI: 0.39-1.28, p = 0.25). CONCLUSION: In this study, no significant difference was observed in moderate/large residual shunt prevalence at 6 months of follow-up between the Occlutech and Amplatzer devices.