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Updated: Mar 23, 2026

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Long-term follow-up after PFO device closure: Outcomes and Complications in a Single-center Experience
Nathaniel W Taggart1, Guy S Reeder2, Ryan J Lennon3
1Division of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota.
Insights
Device closure of patent foramen ovale (PFO) is safe for preventing stroke and TIA. Long-term follow-up shows good shunt resolution, with recurrent events linked to other health conditions, not residual shunting.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Patent foramen ovale (PFO) closure is used for secondary stroke prevention.
- Long-term outcome data for PFO device closure are limited.
Purpose of the Study:
- To evaluate medium- to long-term outcomes of PFO device closure.
- To identify risk factors for recurrent stroke or transient ischemic attack (TIA) after PFO closure.
Main Methods:
- Retrospective review of 730 patients undergoing PFO device closure (2001-2012).
- Analysis of demographic, clinical, procedural, and follow-up data.
- Calculation of recurrent stroke/TIA rates and identification of associated risk factors.
Main Results:
- Median follow-up was 6 years; 6.3% experienced recurrent stroke/TIA.
- Older age, diabetes, and hypertension were associated with recurrent events.
- Residual shunting did not correlate with recurrent neurologic events.
Conclusions:
- PFO device closure is safe and effectively resolves atrial shunting long-term.
- Recurrent events are likely due to comorbid factors rather than residual shunt.
- Further research into managing comorbidities post-PFO closure is warranted.
Objectives:
To describe medium- to long-term follow-up of patients undergoing device closure of patent foramen ovale (PFO) for stroke or transient ischemic attack (TIA).
Background:
Transcatheter device closure of PFO continues to be used for secondary prevention of cryptogenic stroke or TIA, but data are lacking regarding long-term outcomes.
Methods:
We reviewed the Mayo Clinic Rochester PFO database for patients who underwent device closure of PFO for secondary prevention of stroke/TIA from December 2001 to June 2012. Demographic, clinical, procedural, and follow-up data were reviewed. Recurrence rate of stroke/TIA were calculated. Data were analyzed to identify risk factors of recurrent neurologic events.
Results:
Seven hundred and thirty patients (mean age 53 years; 40% female) were included in our study. Most patients (72%) had cryptogenic stroke as their qualifying event for PFO closure. There were no procedure-related deaths or strokes. The most commonly used device was the Amplatzer Septal Occluder (82%). Median follow-up was 6 years. A 3.9% of patients had documented residual right-to-left shunting at last echocardiogram. Recurrent stroke and/or TIA were reported in 45 patients, (6.3% of patients with follow-up data). Patients who experienced recurrent stroke/TIA were older and had a higher rate of diabetes and hypertension than those who did not. The presence of residual shunt did not correlate with risk of recurrent events.
Conclusions:
Device closure of PFO can be performed safely with very good long-term resolution of atrial shunting. Recurrent neurologic events after PFO closure may reflect additional comorbid risk factors unrelated to the potential for paradoxical embolism. © 2016 Wiley Periodicals, Inc.

