The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland Northern Ireland on balloon dilatation with or without stenting for pulmonary artery or non-valvar right ventricular outflow tract obstruction in children.
The right ventricular outflow tract includes the pulmonary valve and the tissue above and below it. Narrowing (stenosis) of this region may involve the area below the valve (subvalvar), the valve itself (valvar) or the area above the valve (supravalvar). Balloon angioplasty of valvar right ventricular outflow tract narrowing (pulmonary valve stenosis) is covered in a separate overview.
Congenital subvalvar and supravalvar right ventricular outflow tract stenosis usually occurs with other cardiac defects such as ventricular septal defect or tetralogy of Fallot. Postoperative right ventricular outflow tract obstruction may occur after surgery to create a conduit between the right ventricle and pulmonary artery in children with congenital anomalies.
Narrowing may also occur beyond the right ventricular outflow tract, in one of the pulmonary arteries, or in their branches. This may also be congenital or occur following surgery for congenital defects.
Balloon dilatation is a minimally invasive transvenous procedure to dilate the obstruction during cardiac catheterisation. Stenting involves the insertion of a small tube within the narrow region following balloon angioplasty. Standard treatment of right ventricular outflow tract or pulmonary artery obstruction involves open chest surgery.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.