This document replaces previous guidance on percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction (interventional procedure guidance 237).
1.1 The evidence on percutaneous pulmonary valve implantation (PPVI) for right ventricular outflow tract (RVOT) dysfunction shows good short-term efficacy. There is little evidence on long-term efficacy but it is well documented that these valves may need to be replaced in the longer term. With regard to safety there are well-recognised complications, particularly stent fractures in the longer term, which may or may not have clinical effects. Patients having this procedure are often very unwell and might otherwise need open heart surgery (typically reoperative) with its associated risks. Therefore, this procedure may be used with normal arrangements for clinical governance, consent and audit.
1.2 The procedure should be performed only in specialist units and with arrangements in place for cardiac surgical support in the event of complications.
1.3 Patient selection should be carried out by a multidisciplinary team including a cardiologist with a special interest in congenital heart disease, an interventional cardiologist and a cardiothoracic surgeon with a special interest in congenital heart disease.
1.4 This is a technically challenging procedure that should be performed only by clinicians with training and experience in interventional cardiology and congenital heart disease.
1.5 Clinicians should enter details about all patients undergoing PPVI for RVOT dysfunction onto the UK Central Cardiac Audit Database (UK CCAD). They should audit and review clinical outcomes locally, and in particular collect information on long-term outcomes.