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J Am Coll Cardiol, 2005; 45:493-495, doi:10.1016/j.jacc.2004.10.055 © 2005 by the American College of Cardiology Foundation |
* Cardiovascular Research, Swedish Medical Center
Spencer Vascular Laboratories, Seattle, Washington
Manuscript received June 11, 2004; revised manuscript received October 14, 2004, accepted October 18, 2004.
* Reprint requests and correspondence: Dr. Jill Jesurum, 801 Broadway, Suite 927, Seattle, Washington 98104 (Email: jill.jesurum{at}swedish.org).
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Abstract |
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BACKGROUND: The prevalence of migraine headache is higher in cryptogenic stroke patients with PFO than in the general population. Previous studies have suggested that closure of the PFO may reduce migrainous symptoms.
METHODS: Between April 2001 and December 2003, 162 consecutive patients with paradoxical cerebral embolism underwent transcatheter PFO closure for prevention of recurrent cryptogenic stroke or transient ischemic attack. A one-year retrospective analysis of migraine symptoms before and after PFO closure was performed.
RESULTS: Active migraine was present in 35% (57 of 162) of patients, and 68% (39 of 57) experienced migrainous aura; 50 patients were available for analysis at one year. Complete resolution of migraine symptoms occurred in 56% (28 of 50) of patients, and 14% (7 of 50) of patients reported a significant (
50%) reduction in migraine frequency. Patients reported an 80% reduction in the mean number of migraine episodes per month after PFO closure (6.8 ± 9.6 before closure vs. 1.4 ± 3.4 after closure, p < 0.001). Results were independent of completeness of PFO closure at one year.
CONCLUSIONS: In patients with paradoxical cerebral embolism, migraine headaches are more frequent than in the general population, and transcatheter closure of the PFO results in complete resolution or marked reduction in frequency of migraine headache.
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Previous publications have demonstrated closure of the PFO in patients with cryptogenic stroke or decompression illness may reduce migraine symptoms (3–6). The purpose of this study is to report the effect of transcatheter PFO closure on migraine frequency in patients with presumed paradoxical cerebral embolism.
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Methods |
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Using a percutaneous, transcatheter approach, a septal occluder device was implanted successfully in all patients. Thereafter, daily antiplatelet therapy consisted of 75 mg of clopidogrel for three months and 325 mg of aspirin for six months. Symptom and standardized migraine questionnaires were administered at baseline and in follow-up to assess cardiac and neurologic status. Migraine events were classified according to International Headache Society criteria (8). Migraine definitions of relief following closure were defined as: 1) complete absence of symptoms; 2) significant, that is, 50% reduction in monthly frequency; and 3) minimal/none, that is, <50% reduction in monthly migraine frequency.
Closure status and residual right-to-left shunt were evaluated serially using pm-TCD with measurements during resting respiration and calibrated Valsalva. Final closure status was based on the number of embolic tracks observed during calibrated Valsalva.
Statistical analysis. Data are reported as means ± standard deviations. Pearson chi-square, and independent samples t test and paired-samples t tests were used to compare categorical, nominal, and continuous variables, respectively. Early and late follow-up of migraine frequency were compared using a within-subjects repeated-measures analysis of variance. Assumptions of normality and homogeneity of variance were satisfied. The level of significance for all tests was set at 0.05 (two-tailed). Data were analyzed using the Statistical Package for the Social Sciences (version release 11.0.1, SPSS Inc., Chicago, Illinois).
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Results |
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50%) reduced in 14% (7 of 50) of patients. Fifteen (30%) patients reported minimal (<50%) or no relief of migraine symptoms. In a subgroup of 21 patients who had serial assessment of migraine frequency at early (18 ± 17 weeks) and late follow-up (40 ± 26 weeks), no significant differences in monthly migraine frequency were found between early (1.6 ± 3.7) and late (1.1 ± 2.6) follow-up (F = 1.69, p = 0.208), suggesting a persistent treatment effect. The degree of migraine relief did not vary according to migraine subtype (Fig. 1). In follow-up, complete PFO closure (
30 embolic tracks) was successfully achieved in 72% (36/50) of patients. Final closure status did not influence the degree of migraine relief. (chi-square test = 0.18, p = 0.91).
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Discussion |
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The significant treatment effect of transcatheter PFO closure on migraine frequency suggests the possibility of a common pathophysiologic substrate for selected patients with migraine and paradoxical embolism. This study is limited, however, by its nonrandomized, uncontrolled design, small sample size, and possibility of recall bias and placebo effect. Although the reported placebo effect in large, randomized trials of migraine prophylaxis (20% to 40%) (10) is significantly lower than the observed treatment effect (70%), it is possible the placement of an intracardiac device may have a more profound placebo effect than medical therapies.
Migraine relief was independent of the completeness of PFO closure, suggesting either a type II error due to insufficient sample-size, an effect based on partial "filtration" of microaggregates, or hypersensitivity of pm-TCD evaluation in quantifying residual shunt. It is possible that some of the treatment effect could be due to aspirin therapy rather than PFO closure; however, this bias is debatable because 50% (25 of 50) of patients were taking aspirin before PFO closure, and the known effect of aspirin on migraine relief is modest (11). Although the effect of combination aspirin and clopidogrel therapy on migraine frequency has not been established, we observed sustained migraine relief after antiplatelet therapy was discontinued. The consistent observations of this and other studies are provocative and worthy of evaluation with a prospective, randomized trial using objective measures of migraine frequency and severity.
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