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 dilatationof systemic to pulmonary arterial shunts in children.
Systemic to pulmonary shunts are surgically-created connections between the aorta and a pulmonary artery in children with cyanotic congenital heart disease such as tetralogy of Fallot or tricuspid atresia. They increase the blood supply to the lungs and the arterial oxygen saturation. The procedure is palliative, aiming to improve symptoms. In some children, definitive surgery may be possible later. The most common type of systemic to pulmonary shunt is known as the Blalock-Taussig shunt.
Systemic to pulmonary shunts may become blocked or narrowed (stenosed) due to scarring or thrombosis. Balloon angioplasty of shunts is a palliative procedure carried out to relieve the blockage or narrowing. The procedure involves inserting a catheter into a large blood vessel (usually in the groin), passing it up in to the chest under X-ray control and inflating a balloon in the narrowed area. This may avoid a repeat surgical systemic to pulmonary shunt procedure.
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.