Patent Foramen Ovale Closure for Treating Migraine: A Meta-Analysis

Table 1

Characteristics of included studies.

Author	Length of follow-up	Study type	Number		Safety of PFO closure	Jadad grade
			PFO group	Control group
Schwerzman et al. [7]	1 Y	RCS	37	11	—	3
Azarbal et al. [13]	1 Y	RCS	24	13	—	3
Dubiel et al. [14]	Mean; 38 M	RCS	24	22	—	3
Slavin et al. [15]	30 ± 16 M	RCS	41	10	—	3
Jesurum et al. [16]	1.5 Y	RCS	55	22	—	3
Mist et al. [9]	6 M	RCT	74	73	16 patients: pericardial effusion in 2 patients, 1 of which required percutaneous drainage, and a retroperitoneal bleed in 1 patient in the implant group, which was managed conservatively. Three serious adverse events that were probably related to antiplatelet medication (incision site bleed, anemia, and nosebleed)	6
Whal et al. [17]	5.0 ± 1.9	RCS	96	54	NO	3
Rigatelli et al. [18]	24–76 M	RCS	63	17	—	3
Prisma et al. [11]	1 Y	RCT	53	54	Six serious adverse events: three device related (one transient atrial fibrillation, one general fatigue, and one syncope), two related to the implant procedure (one access-site bleeding and one retroperitoneal haematoma), and one unrelated (muscle wasting)	7
Premivm et al. [10]	1 Y	RCT	123	107	Six major procedure-related adverse events: arm phlebitis from an intravenous line, groin hematoma and pain, transient hypotension, tachycardia, and a vasovagal episode	7
Eyal et al. [19]	1 Y	RCS	169	—	NO	4
Mohammad et al. [12]	10–12 M	RCT	157	146	Nine procedure-related adverse events (access-site hematoma and transient hypotension) and 4 device-related adverse events (paroxysmal atrial fibrillation)	7

RCT: randomized controlled trial; RCS: retrospective case series; M: months; Y: years.