Related Experiment Video
Updated: Aug 9, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Association of incomplete device apposition with stroke recurrence after patent foramen ovale closure
Chaowu Yan1, Hua Li2, Linyuan Wan3
1Department of Cardiology, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China chaowuyan@163.com.
Insights
Incomplete device apposition (IDA) after patent foramen ovale (PFO) closure is common and linked to higher risks of recurrent stroke and new symptoms. Further research is needed for preventive strategies.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Imaging
Background:
- Stroke recurrence mechanisms post patent foramen ovale (PFO) closure are not fully understood.
- Incomplete device apposition (IDA) is a potential factor influencing outcomes after PFO closure.
- This study investigates IDA using cardiac CT angiography (CTA) and its link to stroke recurrence.
Purpose of the Study:
- To evaluate the prevalence and characteristics of incomplete device apposition (IDA) after transcatheter PFO closure.
- To determine the association between IDA and the risk of recurrent stroke and new-onset symptoms.
- To explore factors associated with IDA.
Main Methods:
- Prospective cohort study of 233 patients undergoing transcatheter PFO closure.
- Cardiac CT angiography (CTA) at 6 months post-procedure to assess IDA.
- Follow-up for recurrent stroke and new-onset symptoms, analyzed for association with IDA.
Main Results:
- IDA was observed in 55.8% of patients, primarily at the anterior-inferior rim.
- IDA was significantly associated with larger PFOs, longer PFOs, larger devices, and greater device thickness.
- Patients with IDA exhibited a higher risk of recurrent stroke and new-onset symptoms during follow-up.
Conclusions:
- Incomplete device apposition (IDA) is a frequent finding after PFO closure.
- IDA is associated with an increased risk of recurrent stroke and new symptoms.
- Preventive strategies for IDA require further investigation.
Background:
The mechanisms underlying stroke recurrence after patent foramen ovale (PFO) closure for secondary prevention remain poorly understood. This study evaluated incomplete device apposition (IDA) using cardiac CT angiography (CTA) and investigated its association with stroke recurrence.
Methods:
In this prospective cohort study conducted at four centres in China (2020-2026), 233 patients (mean age: 37.01±6.73 years; 48.9% male) without known vascular risk factors were included from 382 consecutive candidates who underwent transcatheter PFO closure with follow-up ≥6 months. Cardiac CTA at 6 months post closure assessed the presence, location and extent of IDA defined as a gap between the left disc and the interatrial septum. Recurrent stroke and new-onset symptoms (atrial tachyarrhythmia, migraine headache, chest pain/discomfort) were recorded and their associations with IDA were analysed.
Results:
IDA was observed in 55.8% of patients predominantly at the anterior-inferior rim (93.4%). IDA was significantly associated with larger and longer PFOs, larger devices and greater in vivo device thickness (p < 0.001 for all). During a median follow-up of 20.00 (IQR 18.00-24.00) months, patients with IDA had a higher risk of recurrent stroke (log-rank p = 0.022) and new-onset symptoms (log-rank p < 0.001). In eight patients who underwent repeat CTA, device apposition remained stable after 6-month closure. Pathological validation was available in one patient with severe chest pain/discomfort and a well-apposed device had sufficient endothelialisation.
Conclusion:
IDA is common after PFO closure and is associated with increased risks of recurrent stroke and new-onset symptoms. Preventive strategies warrant further investigation.
Trial Registration Number:
NCT04686253.
