Sustained Long-Term Benefit of Patent Foramen Ovale Closure on Migraine Daniela Trabattoni, * MD, Franco Fabbiocchi, MD, Piero Montorsi, MD, Stefano Galli, MD, Giovanni Teruzzi, MD, Luca Grancini, MD, Pamela Gatto, MD, and Antonio L. Bartorelli, MD Objectives: This single-center, observational, prospective study evaluated the impact of patent foramen ovale (PFO) closure on migraine attacks over time. Background: PFO clo- sure may reduce the frequency and severity of migraine headaches in patients with significant right-to-left shunts. Methods: Between May 2000 and September 2009, 305 consecutive patients (mean age, 43 6 12 years; 54.5% women) with a prior embolic cere- brovascular event underwent PFO closure with the Amplatzer PFO occluder for recur- rence prevention. All patients had right-to-left shunts; the shunts were associated with migraine symptoms in 77 (25%), either alone (n 5 64, 83%) or with aura (n 5 13, 17%). Septal aneurysm was present in 15 (19.5%) migraine patients, and 43 (56%) had a previ- ous transient brain ischemic attack. All migraine patients had a computed tomography scan or magnetic resonance imaging, indicating a previous brain ischemic lesion. All 305 patients underwent transthoracic echocardiography with clinical follow-up at 24 hr, at 3, 6, and 12 months, and then yearly. Results: An acute migraine attack occurred 24–48 hr after PFO closure in 28 (36.4%) of 77 patients. There was a significant reduction (>50%) in the number and intensity of attacks in 46 (60.5%) of 77 patients at the 3-month follow- up. At the 12-month follow-up, migraine had ceased in 23 (46%) patients, and 20 (40%) had a reduction in the migraine recurrence rate and disabling symptoms. These results were maintained at follow-up (mean, 28 6 27 months). There was overall improvement in migraine in 89% of the treated patients. Conclusions: Percutaneous PFO closure in migraineurs may provide beneficial mid-term and long-term results, with significant reduction in the intensity and frequency of headache symptoms. V C 2011 Wiley-Liss, Inc. Key words: patent foramen ovale; migraine; percutaneous PFO closure INTRODUCTION Migraine is a common, chronic neurovascular disor- der characterized by attacks of severe headache, auto- nomic nervous system dysfunction and, in some patients, aura, and disabling neurological symptoms [1,2]. Worldwide, migraine prevalence is as high as 18% in the general population. Increased frequency of patent foramen ovale (PFO) in migraineurs was first reported in 1998 in a case–control study [3]. Since then, others have described a 60% prevalence of PFO in patients suffering from migraine with aura [4]. The presence of a right-to-left shunt (RLS) is thought to be a potent trigger of migraine attacks, although the mechanism is unknown. Moreover, PFO closure has correlated with improved migraine symptoms in several retrospective uncontrolled studies. The aim of this sin- gle-center, prospective study was to assess the impact of PFO closure on migraine attacks over time. METHODS A prospective analysis was performed using data from 305 consecutive patients with PFO who under- went percutaneous closure with implantation of an Amplatzer PFO Occluder (AGA Medical Corp., Plym- outh, MN) between March 2000 and September 2009. Screening Protocol Patients were evaluated (a) by transesophageal echo- cardiography (TEE) and contrast transcranial Doppler (TCD) to assess microemboli signals (MES) and (b) by coagulation analysis and complete laboratory screening Centro Cardiologico Monzino, Department of Cardiovascular Sciences, University of Milan, Milan, Italy Conflict of interest: Nothing to report. *Correspondence to: Daniela Trabattoni, MD, FACC, Centro Cardio- logico Monzino, Via Parea 4-20138 Milan, Italy. E-mail: daniela. trabattoni@ccfm.it Received 9 August 2010; Revision accepted 11 September 2010 DOI 10.1002/ccd.22826 Published online 4 January 2011 in Wiley Online Library (wileyonlinelibrary.com) V C 2011 Wiley-Liss, Inc. Catheterization and Cardiovascular Interventions 77:570–574 (2011)