Valvular & structural heart diseaseCohort study
Association of incomplete device apposition with stroke recurrence after patent foramen ovale closure
- prospective cohort study
- four centres in China (2020-2026)
Authors' 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.
Study context
- Population
- Patients without known vascular risk factors who underwent transcatheter patent foramen ovale (PFO) closure for secondary prevention with follow-up ≥6 monthsincluded from 382 consecutive candidates
- Participants
- 233 patients
- Exposure
- Patients with incomplete device apposition (IDA) vs without IDA
Main finding
As reported in the abstract
Recurrent stroke · median follow-up of 20.00 (IQR 18.00-24.00) months
- IDA: P = 0.022
Observational data: associations, not effects.
Further findings
| Outcome | P value |
|---|---|
| New-onset symptoms (atrial tachyarrhythmia, migraine headache, chest pain/discomfort) · median follow-up of 20.00 (IQR 18.00-24.00) months · higher risk with IDA | P < 0.001 |
Prevalence and location of IDA · 6 months post closure
- IDA observed
- 55.8%
- Predominantly at the anterior-inferior rim
- 93.4%
Factors associated with IDA
- IDA significantly associated with larger and longer PFOs, larger devices and greater in vivo device thickness
- P < 0.001 for all
Device apposition on repeat CT angiography (CTA)
- In eight patients who underwent repeat CTA, device apposition remained stable after 6-month closure
Pathological validation
- Available in one patient with severe chest pain/discomfort; a well-apposed device had sufficient endothelialisation
Original publication
Association of incomplete device apposition with stroke recurrence after patent foramen ovale closure. Heart. Published 7 August 2026. doi:10.1136/heartjnl-2026-327956
Summarised from the published abstract; every number is checked against it