New trials underway:
Clinical trials are now underway to compare Migraine patients who have the PFO closure with Migraine patients who do not. The MIST trial has been completed in England. MIST stands for Migraine Intervention with STARFlex® Technology. The STARFlex® Septal Repair implant is a small medical device made of specially developed knitted mesh and flexible metal frame used to close holes in the heart. The MIST II trial for the United States is now in the enrollment phase.
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% Patients with |
Effect of PFO |
Effect of PFO |
Effect of PFO |
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Post et al study |
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71% reduction |
50% reduction |
Not tested |
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Total |
39 |
in number of |
in number of |
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Migraine w/ aura |
18 |
people with |
people with |
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Migraine w/out aura |
21 |
attacks |
attacks |
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Nonmigrainous |
unknown |
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Note: Seventy-six patients (mean age, 50.7 ±12.9 years) were selected, and 66 completed the questionnaire. In 57 patients, the period between PFO closure and completing the questionnaire was more than 6 months. Migraine was present in 26 of 66 patients (9 men and 17 women; 39.4%). Twelve (18.2%) had Migraine with aura, and 14 (21.2%) had Migraine without aura. Two months after closure, the prevalence of Migraine with aura and Migraine without aura decreased to 6.1% (4/66) and 6.1% (4/66). At 6 months or more, the overall prevalence of Migraine was 15.8% (9/57; p < 0.05 vs. before closure). The prevalences of Migraine with aura and Migraine without aura were 5.3% (3/57; p < 0.05 vs. before closure) and 10.5% (6/57; p < 0.11 vs. before closure). The frequency of Migraine attacks also decreased (p < 0.05). Seven patients were taking potential prophylactic Migraine drugs 6 months after closure.2 |
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% Patients with |
Effect of PFO |
Effect of PFO |
Effect of PFO |
|
Schwerzmann et al study |
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54% decrease |
62% decrease |
No significant |
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Total |
22 |
in the number |
in the number |
decrease in |
|
Migraine w/ aura |
17 |
of attacks |
of attacks |
nonmigrainous |
|
Migraine w/out aura |
5 |
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headaches |
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Nonmigrainous |
11 |
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Note: Among 215 patients referred for percutaneous closure of patent foramen ovale (PFO) after presumed paradoxical embolism, the prevalence of Migraine was assessed. In the year prior to PFO closure, 48 (22%) patients had Migraine, twice the expected prevalence of 10 to 12% in the general European population. In patients with Migraine with aura, percutaneous PFO closure reduced the frequency of Migraine attacks by 54% and in patients with Migraine without aura by 62%. PFO closure did not have an effect on headache frequency in patients with non-Migraine headaches.3 |
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