Percutaneous closure of patent foramen ovale for recurrent migraine - Consultation Document
Interventional procedure consultation document
Percutaneous closure of patent foramen ovale for recurrent migraine
The foramen ovale is a hole in the wall that divides the two upper chambers of the heart at the level of the atria. The hole is present in the heart of a developing fetus, but normally closes up soon after the baby is born. If it fails to close it is known as a patent foramen ovale (PFO). In most people, this doesn’t cause any problems but some studies have suggested that there could be a link between having a PFO and recurrent migraines. This procedure involves passing a device through a large vessel in the groin up into the heart and closing/blocking the hole in the wall of the heart.
The National Institute for Health and Clinical Excellence (NICE) is examining percutaneous closure of patent foramen ovale for recurrent migraine and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about percutaneous closure of patent foramen ovale for recurrent migraine.
This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
- comments on the provisional recommendations
- the identification of factual inaccuracies
- additional relevant evidence, with bibliographic references where possible.
Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.
The process that NICE will follow after the consultation period ends is as follows.
- The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.
For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).
NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.
Closing date for comments: 24 August
Target date for publication of guidance: December 2010
1 Provisional recommendations
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. 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 (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
- Audit and review clinical outcomes of all patients having percutaneous closure of PFO for recurrent migraine (see sections 1.6 and 3.1).
1.3 Patient selection for percutaneous closure of PFO for recurrent migraine should be carried out by a neurologist or other specialist in headache together with an interventional cardiologist. Use of this procedure should be restricted to patients who are severely disabled 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 (www.ccad.org.uk).
1.7 NICE encourages further research into percutaneous closure of PFO for recurrent migraine which should include studies to 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.
2 The procedure
2.1 Indications and current treatments
2.1.1 A patent foramen ovale (PFO) is the persistence of an opening (the foramen ovale) in the septum between the right atrium and left atrium of the heart. In the fetus, the foramen ovale allows blood to bypass the lungs and to pass directly from the venous to the arterial side of the circulation, supplying blood to the brain and body before it returns to the placenta to be oxygenated. After birth the foramen ovale normally closes but in approximately 25% of people it remains either fully or partially patent throughout life. Usually a PFO causes no symptoms, although a “shunt” or movement of blood from the right to left side of the heart may be demonstrable using specialist tests.
2.1.2 Current treatment for patients with recurrent migraine is aimed at either preventing or aborting episodes through medical management. In patients for whom medical therapy has failed, invasive treatments such as nerve blocks or physical therapies such as acupuncture are sometimes used.
2.2 Outline of the procedure
2.2.1 Percutaneous closure of a PFO for recurrent migraine is carried out with the patient under local anaesthesia and intravenous sedation, or general anaesthesia. A small incision is made in the groin and a guidewire and delivery sheath are introduced via the femoral vein into the heart and across the PFO. A closure device is then inserted through the opening via the delivery sheath and released, closing the PFO. The physiological effect of PFO closure in migraine treatment is not understood.
2.2.2 A range of different devices are available for this procedure.
|
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP812overview
|
2.3 Efficacy
2.3.1 A randomised controlled trial (RCT) of 147 patients treated by the procedure (n = 74) or sham (n = 73) reported that 3 patients in each group had experienced no further migraines at 6-month follow-up. The study reported no significant difference in the reduction in median MIDAS score (measures migraine-related disability on a scale of 0–21+, higher score indicates more severe disability) between the procedure and sham groups (from 36 to 17 vs 34 to 18 respectively), frequency of migraine attacks per month (4.82 to 3.23 vs 4.51 to 3.53) or mean migraine headache days (26 to 19 vs 30 to 21 days) over 3 months.
2.3.2 A non-randomised comparative study of 86 patients reported a significant reduction in MIDAS score in the 40 patients treated by the procedure and the 46 patients treated by medical therapy at a mean follow-up of 29.2 months (35.8 to 8.3, p < 0.003 vs 22.6 to 19.1, p = 0.059; significance of between-group difference not stated). All 32 patients with aura before the procedure were aura-free during follow-up.
2.3.3 A case series of 20 patients reported that all had symptom improvement at a mean follow-up of 10 months (MIDAS scores fell from 38.9 to 3.0, p < 0.003).
2.3.4 A case series of 76 patients reported that a microbubble test immediately after the procedure showed a residual shunt in 8% (6/76) (minimal in 4 and moderate in 2). This persisted in 2 patients at 12 months although migraine had resolved in both.
2.3.5 The Specialist Advisers listed key efficacy outcomes as evidence of complete closure, and frequency and severity of migraine.
2.4 Safety
2.4.1 In the RCT of 147 patients, 1 patient had device embolisation into the right atrium and 1 had device prolapse into the right atrium. Both were successfully retrieved with snares without subsequent sequelae. In a third patient, the device failed to deploy.
2.4.2 Pericardial effusion was reported in 2 patients in the RCT of 147 patients (subsequent treatment not reported).
2.4.3 Periprocedural episodes of atrial fibrillation developed in 2 patients in the non-randomised comparative study of 86 patients, 2 patients in the case series of 20 patients and 7 patients in an RCT of 660 patients. The 4 patients in the first 2 studies were successfully treated with antiarrhythmic drugs (the RCT did not report subsequent treatment).
2.4.4 The Specialist Advisers listed anedoctal adverse events as device embolisation, pericardial effusion and worsening migraine.
3 Further information
3.1 For related NICE guidance see www.nice.org.uk
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
July 2010
NICE is also consulting on this procedure for:
Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.
It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 24 August 2010