Valvular & structural heart disease

Standardized Mortality Ratio and Long-Term Stroke Incidence After Patent Foramen Ovale (PFO) Closure: A Register Study

JACC AdvPublished Retrospective cohort study

Authors' conclusion

Patients undergoing PFO closure demonstrated a lower all-cause mortality compared to the general population. The observed rate of subsequent ischemic stroke was consistent with findings from previous randomized controlled trials. New-onset atrial fibrillation following PFO closure and active/previous smoking emerged as modifiable risk factors.

Study context

Population
Patients who underwent PFO closure, 2001–2018, national registers on congenital heart disease and stroke
Participants
827 patients
Outcome
SMR, subsequent stroke and associated risk factors after PFO closure
Follow-up
Median 8.0 years (IQR: 4.8-11.0)
Methodological detailsnational register linkage
  • National register linkage

Main finding

As reported in the abstract

Deaths during follow-up

23

Standardized mortality ratio (SMR)

0.65

all-cause mortality vs general population; 95% CI 0.41–0.98

Ischemic strokes

34

Ischemic stroke incidence rate

0.51 events per 100 patient-years

Observational data: associations, not effects.

Further findings

Risk factors for subsequent ischemic stroke

HR (95% CI)
New-onset atrial fibrillation following PFO closure8.2 (2.6–25.8)
Active/previous smoking2.5 (1.2–5.1)

Subsequent ischemic stroke · median follow-up 8.0 years

Ischemic strokes
34
Incidence rate
0.51 events per 100 patient-years
Receiving antithrombotic therapy at time of stroke (of 34)
27

Original publication

Standardized Mortality Ratio and Long-Term Stroke Incidence After PFO Closure: A Register Study. JACC Adv. Published 19 December 2025. doi:10.1016/j.jacadv.2025.102469

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