BACKGROUND: Some ongoing trials have suggested that closure of the patent foramen ovale (PFO) may reduce migraine symptoms. We sought to assess the safety and effectiveness of migraine treatment by means of PFO transcatheter closure using paradoxical embolism risk-driven criteria. METHODS: We enrolled 75 patients (48 women and 27 men, mean age 40 +/- 3.7 years) who were referred to our center over a 12-month period for a prospective study to evaluate severe disabling migraine, despite antiheadache therapy and the PFO. Migraine Disability Assessment Score (MIDAS) was used to assess the incidence of migraine headache and severity. Criteria for intervention included all of the following: basal shunt, curtain shunt pattern on transcranial Doppler, presence of interatrial septal aneurysm, 3 to 4 class MIDAS score, symptomatic significant aura, coagulation abnormalities, migraine refractory to conventional drugs. RESULTS: On the basis of the inclusion criteria, we shortlisted 20 patients (12 women, mean age 35 +/- 6.7 years, mean MIDAS score 38.9 +/- 5.8) for transcatheter closure of PFO and excluded the rest who were referred to the neurologist for medical therapy. The procedure was successful in all of the patients with no perioperative or in-hospital complications. After a mean follow-up of 10 +/- 3.1 months (range 6-14), all patients' migraine symptoms improved (mean MIDAS score 3.0 +/- 2.1, P < 0.03) with PFO complete closure in all patients on transesophageal and transcranial Doppler ultrasound. CONCLUSION: In this small pilot series, we adopted the criteria which in our opinion best reflected the risk of paradoxical embolism in these patients. By adopting the proposed criteria, primary transcatheter closure of the PFO resulted in a significant reduction in migraine.
BACKGROUND: Some ongoing trials have suggested that closure of the patent foramen ovale (PFO) may reduce migraine symptoms. We sought to assess the safety and effectiveness of migraine treatment by means of PFO transcatheter closure using paradoxical embolism risk-driven criteria. METHODS: We enrolled 75 patients (48 women and 27 men, mean age 40 +/- 3.7 years) who were referred to our center over a 12-month period for a prospective study to evaluate severe disabling migraine, despite antiheadache therapy and the PFO. Migraine Disability Assessment Score (MIDAS) was used to assess the incidence of migraineheadache and severity. Criteria for intervention included all of the following: basal shunt, curtain shunt pattern on transcranial Doppler, presence of interatrial septal aneurysm, 3 to 4 class MIDAS score, symptomatic significant aura, coagulation abnormalities, migraine refractory to conventional drugs. RESULTS: On the basis of the inclusion criteria, we shortlisted 20 patients (12 women, mean age 35 +/- 6.7 years, mean MIDAS score 38.9 +/- 5.8) for transcatheter closure of PFO and excluded the rest who were referred to the neurologist for medical therapy. The procedure was successful in all of the patients with no perioperative or in-hospital complications. After a mean follow-up of 10 +/- 3.1 months (range 6-14), all patients' migraine symptoms improved (mean MIDAS score 3.0 +/- 2.1, P < 0.03) with PFO complete closure in all patients on transesophageal and transcranial Doppler ultrasound. CONCLUSION: In this small pilot series, we adopted the criteria which in our opinion best reflected the risk of paradoxical embolism in these patients. By adopting the proposed criteria, primary transcatheter closure of the PFO resulted in a significant reduction in migraine.