1.1 Current evidence on the safety and efficacy of balloon angioplasty of pulmonary vein stenosis in infants does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research. The available evidence suggests that the procedure is not efficacious. However, there are no special concerns about the safety of the procedure, especially in the context of very ill infants for whom it is used.
1.2 Clinicians wishing to undertake balloon angioplasty of pulmonary vein stenosis in infants should take the following actions:
Inform the clinical governance leads in their Trusts.
Ensure that the parents of patients understand that the limited available evidence indicates a lack of efficacy. Parents should be given clear written information. Use of the Institute's information for the public is recommended.
Audit and review clinical outcomes of all patients having balloon angioplasty of pulmonary vein stenosis in infancy.
1.3 This procedure should only be offered to gravely ill infants with a very poor prognosis, and in the setting of a specialist paediatric cardiology unit.
1.4 The Department of Health runs the UK Central Cardiac Audit Database (UKCCAD) and clinicians are encouraged to enter all patients onto this database.
1.5 Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. The Institute may review the procedure upon publication of further evidence.