1.1 Current evidence on the efficacy of percutaneous closure of patent foramen ovale (PFO) for recurrent migraine is inadequate in quality and quantity. The evidence on safety shows a small incidence of well-recognised but sometimes serious adverse events, including device embolisation and device prolapse (each reported in less than 1% of patients). Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake percutaneous closure of PFO for recurrent migraine should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients and their carers understand the uncertainty about the procedure's efficacy and the possibility of serious complications. Clinicians should provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended.
1.3 Patient selection for percutaneous closure of PFO for recurrent migraine should be carried out by a neurologist or other specialist in headache followed by an interventional cardiologist. Use of this procedure should be restricted to patients who are severely affected by recurrent, refractory migraine.
1.4 The procedure should be done by an interventional cardiologist and supporting team with specific training in the procedure.
1.5 The procedure should only be carried out in units where there are arrangements for emergency cardiac surgical support in the event of complications.
1.6 Data on all patients having this procedure should be submitted to the UK Central Cardiac Audit Database.
1.7 NICE encourages further research into this procedure, which should investigate the uncertainty surrounding the aetiology and natural history of migraine in patients with PFO. NICE may review this procedure on publication of further evidence.