1.1 Current evidence on the efficacy of percutaneous closure of patent foramen ovale (PFO) for the secondary prevention of recurrent paradoxical embolism in divers is inadequate in quality and quantity, and the evidence on safety shows that there is a possibility of serious complications. 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 the secondary prevention of recurrent paradoxical embolism in divers should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about the procedure's efficacy and the possibility of complications, and that they understand alternative options which may include modifying their diving practice to reduce the risk of gas bubble formation. Clinicians should provide patients with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended.
1.3 Patient selection for this procedure should only be carried out by clinicians with specific expertise in decompression sickness, in liaison with an interventional cardiologist.
1.4 The procedure should only be carried out in units where there are arrangements for emergency cardiac surgical support in the event of complications.
1.5 Data on all patients having this procedure should be submitted to the UK Central Cardiac Audit Database.
1.6 NICE encourages further research into this procedure. Studies should document the recurrence of neurological decompression sickness in patients treated by this procedure compared with recurrence among those in whom the PFO is not closed. Outcomes should include details of the depth and duration profile of dives undertaken.