Valvular & structural heart disease

Association of incomplete device apposition with stroke recurrence after patent foramen ovale closure

HeartPublished prospective cohort study

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
Methodological detailsfour centres in China (2020-2026)
  • Four centres in China (2020-2026)

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

OutcomeP 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 IDAP < 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

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