The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Telemetric adjustable pulmonary artery banding for reducing pulmonary hypertension in infants with congenital heart defects, in November 2014.
January 2018: The device linked to this guidance (FloWatch) is no longer available. NICE would consider whether to issue new guidance on Telemetric adjustable pulmonary artery banding for pulmonary hypertension in infants with congenital heart defects should evidence using an appropriately CE marked device become available.
Congenital heart defects with a left-to-right shunt and excessive pulmonary blood flow can result in pulmonary hypertension and congestive heart failure in the neonatal period. The usual treatment is surgical correction of any defect when the infant is big enough. The most common defects needing this type of treatment include functionally univentricular hearts, transposition of the great arteries and atrioventricular or multiple septal defects. The symptoms include fatigue, dyspnoea, tachypnoea and failure to thrive if the lungs are not protected. Infants may develop a condition of irreversible pulmonary hypertension because of hypertrophy of the pulmonary arterioles.
Pulmonary artery banding (PAB) is a palliative procedure that is used as part of staged treatment before definitive surgical correction of congenital heart defects. The aim of PAB is to reduce the diameter of the main pulmonary artery, decreasing blood flow and reducing pulmonary artery pressure. Improvement of systemic pressure, cardiac output and ventricular function can also be expected in patients with a large left-to-right shunt. Risks of the procedure include lowering of systemic oxygen saturation, ventricular hypertrophy, subaortic obstruction, and pulmonary branch and valve distortion. The conventional technique of PAB involves surgical placement of a (not telemetrically adjustable) band around the main pulmonary artery. Different techniques using a variety of materials (such as strips of polytetrafluoroethylene, polydioxanone or nylon) and sutures are used. In non-adjustable PAB methods, reoperation is often needed to adjust the tightness of the band.
L12.1 Application of band to pulmonary artery
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.