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Updated: Jan 31, 2026

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Interaction of cardiac implantable electronic device and patent foramen ovale in ischemic stroke: A case-only study
Kolade M Agboola1, Jin-Moo Lee2, Xiaoyan Liu3
1Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.
Insights
Cardiovascular implantable electronic device (CIED) leads can form clots. This study found no increased risk of stroke in patients with both a CIED and a patent foramen ovale (PFO). The presence of a CIED did not magnify the stroke risk associated with PFO.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Cardiovascular implantable electronic device (CIED) leads can serve as a site for right atrial thrombus formation.
- Patent foramen ovale (PFO) is a potential pathway for right-to-left thromboembolism, leading to ischemic stroke.
- The interaction between CIEDs and PFO in stroke risk is not fully understood.
Purpose of the Study:
- To investigate whether the presence of a CIED modifies the risk of ischemic stroke in patients with a PFO.
- To test the hypothesis that CIEDs amplify the association between PFO and stroke by promoting thrombus formation.
Main Methods:
- A case-only study design was employed using prospectively maintained stroke registry data from 2006-2015.
- Included were consecutive first ischemic stroke patients.
- PFO diagnosis was based on echocardiography, and CIED presence was determined from chest radiography reports.
Main Results:
- The study included 7089 ischemic stroke patients.
- Prevalence of CIED was lower in patients with PFO (8.0%) compared to those without PFO (10.9%), P=0.015.
- This finding was contrary to the initial hypothesis.
Conclusions:
- In hospitalized ischemic stroke patients, a higher prevalence of CIED was not observed in those with PFO.
- The presence of a CIED did not appear to increase the risk of PFO-associated ischemic stroke in the studied population.
Background:
Cardiovascular implantable electronic device (CIED) leads are a nidus for right atrial thrombi. Right-to-left thromboembolism across a patent foramen ovale (PFO) is a putative mechanism for ischemic stroke and PFO has been associated with stroke. We used a novel unbiased case-only study design to assess the effect modification of PFO-associated ischemic stroke risk by presence of CIED. We hypothesized that presence of CIED, as a nidus for right atrial thrombus formation, magnifies the PFO-ischemic stroke relationship; therefore, among hospitalized ischemic stroke patients we would find a higher prevalence of CIED in patients with PFO.
Methods:
We included consecutive first ischemic stroke patients admitted to our hospital from 2006 to 2015, who were enrolled in a prospectively maintained stroke registry. PFO was ascertained from documentation on echocardiography, and presence of CIED at time of stroke was determined from chest radiography reports at or prior to hospitalization. We measured distributions of CIED within PFO and control groups and used Fisher's exact test to evaluate the PFO-CIED association among ischemic stroke patients.
Results:
We included 7089 patients (age: 64.5 ± 14.9 years, 51% female). Echocardiography diagnosed PFO in 760 (10.7%) patients and CIED was reported on chest radiography in 752 (10.6%) patients. Prevalence of CIED was lower in the PFO (61/760, 8.0%) compared to control group (691/6329, 10.9%), P = 0.015.
Conclusion:
Among admitted ischemic stroke patients, we did not find a higher prevalence of CIED in patients with PFO compared to controls. Therefore, in the underlying source population, the presence of CIED did not increase the PFO-associated ischemic stroke risk.
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