Table I. Patient Demographics and Outcomes.

Feature	GSO implantation data (± sd)
Median age (yrs ± SD)	41 ± 9.8 yrs (range 21–57)
Male/female	15/5
Median defect size (balloon size on fluoroscopy)	8.0 ± 3.6 mm (range 2–16.7)
Median radiation dose	283 ± 340 µGym2 (range 6–1,431)
Median fluoroscopic time	3.0 ± 1.7 min (range 0.7–6.3)
% with ASA (deviation >1 cm)	90% (18/20)
Devices used	20 mm, n = 5 25 mm, n = 7 30 mm, n = 8
Median procedure time	34.8 ± 8.0 min (range 22–53)
Closure achieved with bubble study post implant (IVC injection)	20/20
Shunt on transthoracic echo at 1 month	0/14
ECG changes at 1 month	0/14

Patient PFO characteristics and Procedural data. Atrial septal aneurysms were defined as septal excursion greater than 10 mm measured on M-mode through the septum on intracardiac echo. Balloon sizes were all measured on fluoroscopy in LAO cranial projection. Procedural times include initial intracardiac echo assessment and superior and inferior vena caval bubble assessments. Abbreviations: GSO, Gore septal occluder; TIA, transient ischemic attack; CVA; cerebrovascular accident.