Interventional procedures consultation document - extracorporeal membrane oxygenation (adult)

The National Institute for Clinical Excellence is examining extracorporeal membrane oxygenation in adults 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 adults.

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 Procedure 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: 28 October 2003

Target date for publication of guidance: April 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 (ECMO) in adults does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake ECMO in adults should inform the clinical governance leads in their trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

ECMO in adults is under evaluation in the Health Technology Assessment Programme's CESAR trial (Conventional ventilatory support versus Extracorporeal membrane oxygenation for Severe Adult Respiratory failure). Clinicians wishing to undertake this procedure should only do so within this trial.

Indications

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 after heart surgery to assist the transition from cardiopulmonary bypass to ventilation.

Most people treated with ECMO are very ill and at risk of death. The causes of their respiratory and cardiac failure include pneumonia, septic shock, 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 circulation to an external blood pump and artificial lung (oxygenator). A catheter placed in the right side of the heart carries blood to a pump, then to a membrane oxygenator, where exchange of oxygen and carbon dioxide takes place. The blood then passes through tubing back into either the venous or arterial circulation. An anticoagulant is used to prevent blood clotting in the external system.

In four comparative studies survival rates ranged from 10% (4/42 patients) to 55% (27/49 patients). In a case series of 202 patients, 30-day survival was 38% and 5-year survival was 24%. For more details refer to the Overview (see Appendix).

The Specialist Advisors considered that the efficacy of ECMO in adults was poor compared with results in children. They considered that efficacy in adults would remain uncertain until the results of the CESAR trial are published.

In a cohort study of 245 patients, with 62 patients receiving ECMO, rupture of the tubing system occurred in three patients and resulted in one death. Other complications reported in the studies included cannulation injuries, clots in the ECMO circuit and pump malfunction. Complications related to the underlying condition were also reported. For more details refer to the Overview (see Appendix).

Although one Specialist Advisor identified bleeding caused by necessary heparinisation as a particular complication, the Specialist Advisors did not consider the procedure to have major safety risks. Most people treated with ECMO are very ill and many of the adverse effects associated with the procedure are as much inherent in the patient's underlying condition as caused by the procedure.

The Advisory Committee noted that the evidence relating to neonates is not generalisable to adults, who have more heterogeneous indications for the procedure.

NICE will also publish guidance on ECMO in postneonatal children 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 in Adults, November 2002

Available from: www.nice.org.uk/ip029overview