Related Experiment Video
Updated: Jul 4, 2026
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
Objectives:
To evaluate all complications that occurred during or after cardiac catheterizations for Amplatzer PFO device closure of patent foramen ovale (PFO), determine the cause of the complications and recommend techniques to minimize complications in the future.
Background:
Rare complications were reported to the manufacturer of the Amplatzer PFO occluder since the introduction of the device.
Methods:
A panel of independent physicians reviewed all complications reported to the manufacturer to determine whether the complication was related to the device or related to the cardiac catheterization procedure. Demographic data, echocardiograms, operative reports, and time to occurrence of complications were reviewed.
Results:
A total of 11 events were reported. Only two patients had device related complications (erosion), an incidence of 0.018%. Two patients were found to have additional atrial septal defect after PFO closure. Two patients were thought to have an inflammatory reaction without any serious sequelae. Five complications were related to the cardiac catheterization procedure (atrial appendage perforation).
Conclusions:
Device related complications after Amplatzer PFO occluder placement are extremely rare. Cardiac catheterization related complications appear to be the most common cause of the hemodynamic compromise. Careful manipulation of catheters and wires, recognition of the location of the catheter by fluoroscopy and echocardiography will decrease the risk of such complications.
Insights
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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