Table 2

Procedural data

	Amplatzer	p Value (a/h)	Helex	p Value (h/p)	Premere	p Value (a/p)
Number implanted	80 (48)		48 (29)		38 (23)
Age	45±13 (18–73)	0.07	49±12 (18–81)	0.26	46±12 (18–81)	0.48
Clinical follow-up duration	17.8±8.7 (6.2–38.5)	0.72	18.3±8.1 (6.1–33.0)	0.01	14.5±5.4 (6.2–25.5)	0.04
Indication for closure:
Stroke	37		23		16
TIA	29		19		19
Peripheral embolus	1		1		0
Decompression	11		4		3
Orthodeoxia	1		1		0
Procedure time (min)	36±17 (19–109)	0.30	40±19 (22–132)	0.68	39±9 (25–67)	0.49
Fluoroscopy time (min)	10±7 (2–36)	0.31	8±5 (3–27)	0.70	8±3 (5–19)	0.19
PFO morphology
Balloon waist size	8.6±3.7 (2–17)	0.41	8.1±3.0 (3–14)	<0.01	6.6±1.7 (3–10)	<0.01
Tunnel	6 (7.5)	0.9	4 (8.3)	<0.01	19 (50)	<0.01
Aneurysm	23 (28.7)	0.6	16 (33.3)	0.06	6 (15.8)	0.1
Device size:	PFO device 25 mm: n=66 ASD device: n=14 (17.5), 9–16 mm		20 mm: n=10 25 mm: n=35 30 mm: n=3		25 mm: n=37 20 mm: n=1
6 Months' follow-up
No shunt	54 (67.5)	<0.01	20 (41.7)	0.08	23 (60.5)	0.5
Residual shunt:	26 (32.5)		28 (58.3)		15 (39.5)
Shunt ≥large	14 (17.5)		22 (45.8)		9 (23.7)
Shunt moderate	12 (15)		6 (12.5)		6 (15.8)
12 Months' follow-up
No shunt	68 (85)	<0.01	30 (62.5)	0.07	29 (79)	0.5
Residual shunt:	12 (15)		18 (37.4)		8 (21)
Shunt ≥large	6 (7.5)		15 (31.2)		4 (10.5)
Shunt moderate	6 (7.5)		3 (6.2)		4 (10.5)
Final follow-up
No shunt	71 (89)	<0.01	32 (66.7)	0.2	31 (81.6)	0.1
Residual shunt:	9 (11)		16 (33.3)		7 (18.5)
Shunt ≥large	6 (7.5)		12 (25)		5 (13.2)
Shunt moderate	3 (3.75)		4 (8.3)		2 (5.3)

Results are shown as number (%) or mean±SD (range).
ASD, atrial septal defect; PFO, patent foramen ovale; TIA, transient ischaemic attack.