title: Resolution of migraine by transcatheter patent foramen ovale closure with Premere Occlusion System in a preliminary series of patients with previous cerebral ischemia.
abstract: BACKGROUND
  Transcatheter closure of PFO with nitinol devices may be problematic in young patients with migraine due the risk of late erosions. Alternative devices with less amount of metal as the last generation devices may be preferable in such cases. We present the results of transcatheter closure of PFO with the last generation Premere Occlusion System device in a preliminary series of young adults with migraine and previous cerebral ischemia.
  
  
  METHODS
  During a 12-month period (January 31, 2006 to December 31, 2006) 26 patients (18 female and 8 male, mean age 40 +/- 3.7 years) with previous stroke and severe disabling migraine were referred to our center for transcatheter closure of PFO. Migraine disability assessment score (MIDAS) was used to assess MHA incidence and severity. Patients were selected for Premere occlusion system (absence of atrial septal aneurysm and length >15 mm) on the basis of presence/absence of right and left bulging atrial septal aneurysm and length of PFO channel (<15 mm or >15 mm) on transesophageal echocardiography. Transesophageal echocardiography and transcranial Doppler were performed at 1 month, transthoracic echocardiography and cerebral magnetic resonance imaging at 6 and 12 months. Cardiologic and neurological visit was scheduled at 1, 6, and 12 months with MIDAS questionnaire administration.
  
  
  RESULTS
  Ten patients (2 males, mean age 32 +/- 7.6 years, mean MIDAS score 38.9 +/- 5.8) underwent transcatheter PFO closure with the Premere occlusion system. Mean fossa ovalis diameters by ICE measurement was 20.6 +/- 3.1 mm. Thus, two 20-mm and eight 25-mm Premere devices were implanted. The procedure was successful in all of the patients with no perioperative and in-hospital complications. After a mean follow-up of 10.9 +/- 5.8 months, all patients were free from migraine symptoms (mean MIDAS score 2.9 +/- 1.9) with PFO complete closure in all patients on transesophageal and transcranial Doppler ultrasound.
  
  
  CONCLUSIONS
  While waiting for larger studies evaluating the impact of new generation devices in curing PFO-related migraine, this preliminary anecdotal series suggests that the Premere occlusion system may be an effective and safe device for young patients with previous cerebral ischemia and migraine at least in the midterm period.
authors.affiliation: PFO-Related Syndromes Management Program, Cardiovascular Diagnosis and Interventions Service, Rovigo General Hospital, Italy. jackyheart@hotmail.com
authors.forename: Gianluca
authors.initials: G
authors.lastname: Rigatelli
authors.forename: Paolo
authors.initials: P
authors.lastname: Cardaioli
authors.forename: Gabriele
authors.initials: G
authors.lastname: Braggion
authors.forename: Massimo
authors.initials: M
authors.lastname: Giordan
authors.forename: Dell'Avvocata
authors.initials: D
authors.lastname: Fabio
authors.forename: Silvio
authors.initials: S
authors.lastname: Aggio
authors.forename: Loris
authors.initials: L
authors.lastname: Roncon
authors.forename: Mauro
authors.initials: M
authors.lastname: Chinaglia
mesh_terms: D000328:Adult; D021721:Balloon Occlusion / Q000295:instrumentation*; D002545:Brain Ischemia / Q000150:complications* / Q000175:diagnosis; D006328:Cardiac Catheterization / Q000379:methods*; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000175:diagnosis / Q000209:etiology / Q000628:therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome; D017585:Ultrasonography, Doppler, Transcranial