The hybrid procedure to which these recommendations apply consists of pulmonary artery banding, stenting of the ductus arteriosus and, if necessary, atrial septostomy.
1.1 Current evidence on the safety and efficacy of the hybrid procedure for interim management of hypoplastic left heart syndrome (HLHS) in neonates does not cover sufficiently all the parts of the procedure (see italicised text above) when used in combination and synchronously. The procedure should therefore only be used with special arrangements for consent, audit or research, and clinical governance.
1.2 Clinicians wishing to undertake the hybrid procedure for interim management of HLHS in neonates should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that parents or carers understand the uncertainty about the procedure's safety and efficacy, and understand that the child will require further operations. They should provide parents or carers with clear written information. In addition, use of the Institute's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having the hybrid procedure for interim management of HLHS in neonates
1.3 The procedure should only be undertaken in paediatric cardiology centres specialising in the treatment of HLHS.
1.4 Clinicians undertaking this procedure should enter all patients onto the Department of Health's UK Central Cardiac Audit Database.
1.5 Further publication about criteria for patient selection and on the particular combination of techniques used in the hybrid procedure would be useful. The Institute may review the procedure upon publication of further evidence.