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Updated: Jul 4, 2026
10:52
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
PFO closure complications from the AGA registry.
Zahid Amin1, Ziyad M Hijazi, John L Bass
1RUSH University Medical Center, Chicago, Illinois 60612, USA. zahid_amin@rush.edu
Summary
Complications from Amplatzer Patent Foramen Ovale (PFO) device closure are rare. Most issues stem from the cardiac catheterization procedure, not the device itself, highlighting the need for careful technique.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Device Safety
Background:
- The Amplatzer PFO occluder has been associated with rare complications since its introduction.
- Manufacturer reports prompted an investigation into device and procedural complications.
Purpose of the Study:
- To comprehensively evaluate complications during and after Amplatzer PFO device closure.
- To identify the causes of these complications.
- To recommend strategies for minimizing future risks.
Main Methods:
- Independent physician panel reviewed manufacturer-reported complications.
- Analysis included demographic data, echocardiograms, operative reports, and timing of events.
- Distinguished between device-related and procedure-related complications.
Main Results:
- Eleven total events were reported.
- Device-related complications (erosion) occurred in 0.018% of cases (2 patients).
- Five complications were linked to the cardiac catheterization procedure (atrial appendage perforation).
Conclusions:
- Device-related complications with the Amplatzer PFO occluder are exceptionally rare.
- Cardiac catheterization procedures represent the primary source of complications.
- Enhanced fluoroscopic and echocardiographic guidance, along with meticulous catheter manipulation, can reduce procedural risks.
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