The National Institute for Clinical Excellence is examining extracorporeal membrane oxygenation in postneonatal children and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about extracorporeal membrane oxygenation in postneonatal children.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 23 September 2003

Target date for publication of guidance: March 2004

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of extracorporeal membrane oxygenation in postneonatal children appears adequate to support the use of this procedure, provided that the normal arrangements for consent, audit and clinical governance are in place.

All children undergoing this treatment, including those treated after cardiopulmonary bypass, should be entered onto the international registry of the Extracorporeal Life Support Organization (ELSO), based at the University of Michigan, USA (www.elso.med.umich.edu).

Extracorporeal membrane oxygenation (ECMO) is used to treat respiratory or cardiac failure that is unresponsive to all other measures, but is considered to have a reversible cause. ECMO may also be used following heart surgery in postneonatal children to ease the transition from cardiopulmonary bypass to ventilation. Postneonatal children are those who are at least one month old.

Most children treated with ECMO are very ill and at risk of death. The causes of respiratory and cardiac failure in children include: pneumonia; septic shock; congenital heart disease; cardiomyopathy; severe burns; and pulmonary haemorrhage.

Conventional treatment is maximal intensive care support without ECMO.

ECMO is a temporary life support technique. It involves connecting the patient's internal circulation to an external blood pump and artificial lung. A catheter placed in the right side of the heart carries blood to a pump, then to a membrane oxygenator, where gas exchange of oxygen and carbon dioxide takes place. The blood then passes through tubing back into either the venous or arterial circulation. Patients are given an anticoagulant to prevent blood clotting in the external system.

Most of the evidence reviewed comprised case series from the ELSO database, and these ranged in size from 67 to 763 patients. Survival rates ranged from 40% (27/67 patients) to 71% (91/128 patients). The largest case series of 763 patients reported a 57% survival rate. For more details refer to the Overview (see Appendix A).

The Specialist Advisors considered that the efficacy of ECMO in providing cardiorespiratory support in postneonatal children is proven. They considered that the outcome of this group of patients is reasonably well known from the worldwide ELSO database.

From the studies, the most common complications included bleeding (with an incidence between 40% [27/67] and 58% [137/237]) and renal failure (the largest case series reported this at 45% [343/763]). Other less frequent complications included seizures and haemolysis.

The Specialist Advisors considered that the incidence of complications associated with ECMO was low. They listed infection, bleeding, neurological damage and technical problems with the ECMO circuit as potential complications. However, they considered that the procedure was sufficiently well-established in the centres in which it was used and was delivered by trained specialists in a manner designed to minimise risks.

The Health Technology Assessment Programme's CESAR trial (conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure) will provide additional evidence about the use of the procedure in adults.

NICE will publish guidance on ECMO in adults in 2004, after public consultation.

The evidence considered by the Interventional Procedures Advisory Committee is described in the following document.

• Interventional Procedure Overview of Extracorporeal Membrane Oxygenation for Postneonatal Children, December 2002