August 9, 2026Heart0 citations
View Full PaperAssociation of incomplete device apposition with stroke recurrence after patent foramen ovale closure
Key Result
Incomplete device apposition after patent foramen ovale closure was associated with a higher risk of recurrent stroke (log-rank P=0.022) and new-onset symptoms (log-rank P<0.001).
Key Points
- This study aims to evaluate the relationship between incomplete device apposition and stroke recurrence after PFO closure.
- Conducted as a prospective cohort study across four centers in China with 233 patients.
- Patients underwent cardiac CT angiography to assess incomplete device apposition post PFO closure.
- Follow-up was maintained for a minimum of 6 months post-procedure.
- 55.8% of patients exhibited incomplete device apposition, particularly at the anterior-inferior rim.
- Patients with incomplete device apposition had a significantly higher risk of recurrent stroke (log-rank p = 0.022) and new-onset symptoms (log-rank p < 0.001).
- Pathological validation demonstrated endothelialisation despite incomplete apposition in one patient.
Study Design
Type
Cohort (n=233)
Multicenter
Yes
Structured PICO
Does incomplete device apposition increase the risk of recurrent stroke in patients who underwent transcatheter PFO closure?
P
Population
233 patients without known vascular risk factors who underwent transcatheter PFO closure, followed for a median of 20 months.
E
Exposure
Presence of incomplete device apposition (IDA) assessed by cardiac CT angiography at 6 months post-closure
C
Comparator
Absence of incomplete device apposition (well-apposed device)
O
Outcome
Recurrent strokehard clinical
Incomplete device apposition after PFO closure is common and is associated with an increased risk of recurrent stroke and new-onset symptoms.
Main Result
p-value: p=0.022
Abstract
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 .
Cite This Study
Yan et al. (Fri,) conducted a cohort in Patent foramen ovale (PFO) closure (n=233). Incomplete device apposition (IDA) vs. Complete device apposition was evaluated on Recurrent stroke (p=0.022). Incomplete device apposition after patent foramen ovale closure was associated with a higher risk of recurrent stroke (log-rank P=0.022) and new-onset symptoms (log-rank P<0.001).