1.1 Current evidence on the safety and efficacy of percutaneous fetal balloon valvuloplasty for pulmonary atresia with intact ventricular septum does not appear adequate for this procedure to be used without special arrangements for consent and for audit or research.
1.2 Clinicians wishing to undertake percutaneous fetal balloon valvuloplasty for pulmonary atresia with intact ventricular septum should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that parents understand the uncertainty about the procedure's safety and efficacy. Clinicians should provide parents with clear written information, and with counselling and support both before and after the procedure. In addition, use of the Institute's information for the public is recommended.
Audit and review the clinical outcomes of percutaneous fetal balloon valvuloplasty for pulmonary atresia with intact ventricular septum.
1.3 This procedure should only be performed in centres specialising in invasive fetal medicine and in the context of a multidisciplinary team including a consultant in fetal medicine, a paediatric cardiologist, a neonatologist, a specialist midwife and a paediatric cardiac surgeon.
1.4 An intention-to-treat registry has been developed by the Association for European Paediatric Cardiology, and clinicians are encouraged to enter all cases into this registry.
1.5 Further publication on the criteria for selecting patients for this procedure rather than treating them conservatively until delivery will be useful. The Institute may review the procedure upon publication of further evidence.