PFO closure complications from the AGA registry.
OBJECTIVE
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.
Amin
Zahid
Z
RUSH University Medical Center, Chicago, Illinois 60612, USA. zahid_amin@rush.edu
Hijazi
Ziyad M
ZM
Bass
John L
JL
Cheatham
John P
JP
Hellenbrand
William
W
Kleinman
Charles S
CS
D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation*; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D011183:Postoperative Complications / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D011859:Radiography; D012042:Registries; D012189:Retrospective Studies; D013997:Time Factors; D014463:Ultrasonography