The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on endovascular atrial septostomy.
The main indication for this procedure is transposition of the great arteries, an uncommon congenital cardiac anomaly in which the aorta arises from the right ventricle and the pulmonary trunk arises from the left ventricle. Less commonly, septostomy is carried out in children with other cyanotic congenital abnormalities.
Endovascular atrial septostomy is a procedure that is used to enlarge the foramen ovale. A catheter is passed through a large vein, usually in the groin, into the right atrium and through the foramen ovale to the left atrium. A balloon at the end of the catheter is inflated and pulled back into the right atrium, so enlarging the foramen ovale. Static balloon atrial septostomy is a procedure that is used to enlarge an inter-atrial communication when simple balloon septostomy is unsuccessful or contraindicated. It is usually used in older children or adults with a thick septum in whom there is no atrial communication. The septum is cut using a catheter with a blade at its end. The balloon is then used to enlarge the opening in the septum. The procedure aims to prolong survival until definitive surgery can be performed.
Without a treatment to make a connection between the right and left atria, most babies would not survive. The only babies likely to survive for even a few weeks without septostomy are those with a congenital ventricular septal defect. There is no reliable alternative to septostomy procedures in neonates. Definitive surgery is usually done several months after septostomy.
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.