The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on balloon angioplasty of pulmonary vein stenosis in infants.
As part of the NICE's work programme, the current guidance was considered for review but did not meet the review criteria as set out in the IP process guide. The guidance below therefore remains current.
This procedure is used to treat pulmonary vein stenosis.
Pulmonary vein stenosis (narrowing) may be congenital, or acquired following surgery to correct other congenital cardiac anomalies. It is rare. Untreated, it leads to severe lung damage. It is often associated with other cardiac abnormalities.
Balloon angioplasty of pulmonary vein stenosis, sometimes combined with stenting, is a palliative treatment of children with a very poor prognosis, or sometimes a temporary measure for children awaiting further interventions.
The procedure involves dilatation of the narrowing using a balloon, during a transarterial cardiac catheterisation procedure. A stent may be inserted following dilatation to maintain patency. There is no reliable alternative treatment.
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.