Endovascular atrial septostomy

# Guidance
Current evidence on the safety and efficacy of endovascular atrial septostomy appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance.
Endovascular atrial septostomy should be undertaken only by specialist paediatric cardiology teams.
The Department of Health runs the UK Central Cardiac Audit Database (UKCCAD) and clinicians are encouraged to enter all patients onto this database.# The procedure

# Indications
This procedure is undertaken to relieve the symptoms of cyanotic congenital heart disease by improving the flow of oxygenated blood to the systemic circulation. There are several types of cyanotic congenital heart disease for which this procedure is indicated. Among these 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. This results in two separate circuits of blood flow, in which highly oxygenated blood recycles through the lungs, while oxygen-depleted blood recycles around the body. As a result, the baby develops a blue colour (cyanosis) shortly after birth. The baby can survive for a few days because the foramen ovale (a small hole in the fetal interatrial septum) allows some oxygenated blood to mix with the blood that is being recirculated around the body. However, the foramen ovale normally closes days after birth, and the only babies then likely to survive are those with a congenital ventricular septal defect.
There is no reliable alternative to septostomy procedures in babies.

# Outline of the procedure
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. In simple balloon septostomy, a balloon at the end of the catheter is inflated and pulled back into the right atrium, so enlarging the foramen ovale. When this procedure is unsuccessful or contraindicated, static balloon atrial septostomy is used to enlarge an inter-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.

# Efficacy
No controlled studies were identified and many of the studies found were published more than 15 years ago. One of the studies reported an 'immediate haemodynamic effect' in 95% (508/535) of patients. Another reported a mean increase in arterial oxygen saturation of 21%; two other studies reported increases of 21% and 16% in median systemic arterial oxygen saturation. For more details, refer to the Sources of evidence section.
The Specialist Advisors regarded this procedure as established practice. They also noted that the septostomy may close spontaneously, necessitating surgical septectomy.

# Safety
Among the identified studies, mortality from the procedure ranged from 2% (2/104, 3/149) to 3% (3/108). One study reported a minor complication rate of 10% (26/248) and a lethal complication rate of 1% (3/248). For more details, refer to the Sources of evidence section.
The Specialist Advisors considered the main safety concerns to be death, transient arrhythmias and cardiac injuries.

# Other comments
This procedure has become established as a life-saving measure for severely ill neonates, but clinical trial data are very limited.
The majority of the evidence relates to the simple balloon method.
The evidence on static balloon atrial septostomy is more limited.
Andrew DillonChief ExecutiveAugust 2004# Further information 

# Sources of evidence
The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.
'Interventional procedure overview of endovascular atrial septostomy', March 2003.

# Information for patients
NICE has produced information on this procedure for patients and carers ('Understanding NICE guidance'). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.# About this guidance
NICE interventional procedure guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland.
This guidance was developed using the NICE interventional procedure guidance process.
We have produced a summary of this guidance for patients and carers. Information about the evidence it is based on is also available.
Changes since publication
May 2012: minor maintenance.
Your responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties.
Copyright
 National Institute for Health and Clinical Excellence 2004. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.
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