Key result
Occlutech device shows no significant difference in 6-month residual shunt versus Amplatzer for PFO closure.
Why the study?
Moderate to large residual shunt after percutaneous PFO closure is associated with an increased risk of recurrent stroke, yet comparative data on residual shunt prevalence by device type are scarce.
Does percutaneous PFO closure with an Occlutech device reduce the prevalence of moderate to large residual shunt at 6 months compared to an Amplatzer device in patients undergoing successful percutaneous PFO closure?
Cohort (n=413)
Yes
Does percutaneous PFO closure with an Occlutech device reduce the prevalence of moderate to large residual shunt at 6 months compared to an Amplatzer device in patients undergoing successful percutaneous PFO closure?
This retrospective cohort study found no statistically significant difference in the prevalence of moderate to large residual shunt at 6 months following percutaneous PFO closure between Occlutech and Amplatzer devices.
No device difference in residual shunt; leaves open optimal device selection after PFO closure.
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.
No takes yet. Share an insight, caveat, or question.
Nieuwendijk et al. (2026) conducted a cohort in Patent foramen ovale (PFO) (n=413). Occlutech PFO closure device vs. Amplatzer PFO closure device was evaluated on Prevalence of moderate to large residual shunt at 6 months (OR 0.71, 95% CI 0.39-1.28, p=0.11). Percutaneous PFO closure with Occlutech showed no significant difference in moderate/large residual shunt at 6 months compared to Amplatzer (14.9% vs 22.2%, p=0.11; OR 0.71, 95% CI 0.39-1.28).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: