Table 5.
Comparison of patients with and without PFO closure within study groups A, B, and C
| Variable | Group A | Group B | Group C | ||||||
|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|||||||
| PFO closed | PFO not closed | P value | PFO closed | PFO not closed | P value | PFO closed | PFO not closed | P value | |
| Patients (n) | 67 | 108 | – | 8 | 21 | – | 5 | 16 | – |
| Age, years | 50.3 ± 13.2 | 43.0 ± 9.9 | <0.0001 | 52.6 ± 17.3 | 47.7 ± 14.4 | NS | 49.7 ± 6.4 | 42.4 ± 15.9 | NS |
| Males | 25 (37%) | 31 (29%) | NS | 2 (25%) | 8 (38%) | NS | 2 (40%) | 10 (62%) | NS |
| Hyperlipidemia | 18 (27%) | 9 (8%) | 0.02 | 2 (25%) | 5 (24%) | NS | 0 | 3 (19%) | NS |
| HTN | 14 (21%) | 13 (12%) | NS | 2 (25%) | 6 (29%) | NS | 2 (40%) | 3 (19%) | NS |
| DM | 3 (4%) | 4 (4%) | NS | 0 | 0 | – | 0 | 0 | – |
| Hypercoagulability | |||||||||
| Total | 17 (25%) | 19 (18%) | NS | 2 (25%) | 5 (24%) | NS | 2 (40%) | 3 (19%) | NS |
| Venous coagulopathy | 4 (23%) | 4 (21%) | NS | 1 (50%) | 5 (100%) | NS | 2 (100%) | 3 (100%) | NS |
| Arterial coagulopathy | 13 (76%) | 15 (79%) | NS | 1 (50%) | 0 | NS | 0 | 0 | – |
| PFO closure device used | |||||||||
| CardioSEAL | 9 (13%) | – | – | 0 | – | – | 1 (20%) | – | – |
| Amplatzer | 34 (51%) | – | – | 3 (37%) | – | – | 0 | – | – |
| Helex | 24 (36%) | – | – | 5 (62%) | – | – | 4 (80%) | – | – |
| Complications after procedure | 3 (4%) | – | – | 0 | – | – | 0 | – | – |
| Presence of residual shunt at 12-month follow-up* | 5 (7%) | – | – | 0 | – | – | 0 | – | – |
| Migraine headaches and/or visual aura symptoms on initial assessment (days per month) | 6.2 ± 6.9 | 6.6 ± 8.6 | NS | 6.9 ± 4.3 | 6.0 ± 7.1 | NS | 2.4 ± 2.2 | 1.4 ± 1.4 | NS |
| Migraine headaches and/or visual aura symptoms on 12-month follow-up (days per month) | 1.1 ± 2.4 | 6.7 ± 15.7 | 0.004 | 0.9 ± 2.3 | 6.1 ± 7.3 | 0.06 | 0.2 ± 0.4 | 1.1 ± 1.3 | NS |
| Preventive treatment for migraine on initial assessment (number of patients) | 25 (37%) | 38 (35%) | NS | 1 (12%) | 12 (57%) | 0.04 | 1 (20%) | 9 (56%) | NS |
| Preventive treatment for migraine on initial assessment (number of drugs) | 1.6 ± 0.9 | 1.5 ± 1.2 | NS | 0.1 ± 0.3 | 1.2 ± 0.4 | <0.0001 | 0.8 ± 1.1 | 1.9 ± 0.8 | 0.02 |
| Preventive treatment for migraine at 12-month follow-up (number of patients) | 23 (34%) | 31 (29%) | NS | 0 | 12 (57%) | 0.009 | 1 (20%) | 9 (56%) | NS |
| Preventive treatment for migraine at 12-month follow-up (number of drugs) | 1.7 ± 0.9 | 1.7 ± 1.3 | NS | 0 | 1.2 ± 0.4 | <0.0001 | 0.8 ± 1.1 | 1.9 ± 0.8 | 0.02 |
Note:
*
Includes patients with known pulmonary arteriovenous malformations.
Abbreviations: DM, diabetes mellitus; PFO, patent foramen ovale; HTN, hypertension; ns, not statistically significant.