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Updated: Jun 17, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Incidence of Atrial Fibrillation or Arrhythmias After Patent Foramen Ovale Closure
Keeley S Ravellette1, Jeff Gornbein2, Jonathan M Tobis3
1David Geffen School of Medicine, UCLA, Los Angeles, California.
Insights
Percutaneous patent foramen ovale closure increases atrial fibrillation risk, especially with the Gore Cardioform device. Larger devices and male sex also elevate this risk, necessitating careful patient selection and monitoring.
Area of Science:
- Cardiology
- Medical Devices
- Electrophysiology
Background:
- Percutaneous patent foramen ovale (PFO) closure may increase atrial fibrillation (AF) risk compared to medical management.
- Postclosure AF is generally well-tolerated but can elevate stroke risk.
- Existing data on AF incidence across different PFO closure devices is uncertain.
Purpose of the Study:
- To evaluate the frequency of postclosure AF, atrial flutter, and arrhythmias.
- To compare incidence across six specific PFO closure devices.
Main Methods:
- Retrospective analysis of 445 patients undergoing percutaneous PFO closure (2001-2021).
- Utilized six device types: Amplatzer PFO, Amplatzer ASD, Amplatzer Cribriform, CardioSEAL, Helex, and Cardioform.
- Assessed arrhythmias via ECG within 6 months; logistic regression identified predictors.
Main Results:
- Postclosure AF/atrial flutter occurred in 6.7% of patients within 6 months.
- Incidence varied significantly by device, with Gore Cardioform showing the highest rate (16.8%).
- Gore Cardioform device, larger device size, and male sex were associated with increased AF/atrial flutter risk.
Conclusions:
- Postclosure AF/atrial flutter is more frequent with the Gore Cardioform device, in males, and with larger device sizes.
- The Gore Cardioform device is an independent predictor of postclosure AF/atrial flutter.
- Device selection and patient factors influence arrhythmia risk after PFO closure.
Background:
Patients with a patent foramen ovale (PFO) who undergo percutaneous PFO closure are at a greater risk of developing atrial fibrillation (AF) compared with patients whose PFOs are managed medically. Postclosure AF appears to be well tolerated if treated but may increase the risk for stroke. Postclosure AF is reported to occur in 3.7% to 7.4% of patients; however, incidence across devices remains uncertain. This study aims to evaluate the frequency of postclosure AF, atrial flutter, and arrhythmias in 6 PFO closure devices.
Methods:
Four hundred forty-five patients underwent percutaneous PFO closure with appropriate follow-up between 2001 and 2021. The procedure was performed using Abbott Amplatzer PFO, Amplatzer ASD, Amplatzer Cribriform, NMT CardioSEAL, Gore Helex, or Gore Cardioform devices. Incidence of AF, atrial flutter, and arrhythmias were assessed by electrocardiogram within 6 months from closure. Multivariate logistic regression evaluated potential predictors of postclosure AF or atrial flutter.
Results:
Postclosure AF or atrial flutter occurred in 30 patients (6.7%) within 6 months, and its incidence was significantly different across devices. Gore Cardioform had the greatest frequency of postclosure AF or atrial flutter events (16.8%) compared with other devices. The Gore Cardioform device, larger device sizes, and male sex were associated with greater risk of postclosure AF or atrial flutter.
Conclusions:
Postclosure AF or atrial flutter was more likely to occur in the Gore Cardioform device, in males, and in patients who underwent PFO closure with larger devices. Although it is more effective for complete closure, the Gore Cardioform device was shown to be an independent predictor of postclosure AF or atrial flutter.
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