Interventional procedure consultation document

Extracorporeal membrane oxygenation (ECMO) for acute heart failure in adults

Heart failure can be caused by a number of factors that make the heart a less efficient pump. Extracorporeal membrane oxygenation (ECMO) is similar to a heart–lung bypass machine (used during heart surgery), which both pumps and oxygenates blood. Unlike a heart–lung bypass machine it tends to be used for days and not hours, allowing time for the heart to recover.

The National Institute for Health and Care Excellence (NICE) is examining extracorporeal membrane oxygenation (ECMO) for acute heart failure in adults and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of specialist advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about ECMO for acute heart failure in adults.

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

·       comments on the provisional recommendations

·       the identification of factual inaccuracies

·       additional relevant evidence, with bibliographic references where possible.

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

The process that NICE 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·       The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website.

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 19 December 2013

Target date for publication of guidance: March 2014

 

 

 

1                      Provisional recommendations

 

1.1                  The evidence on the efficacy of extracorporeal membrane oxygenation (ECMO) for acute heart failure in adults is adequate but there is uncertainty about which patients are likely to benefit from this procedure, and the evidence on safety shows a high incidence of serious complications. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2                  Clinicians wishing to undertake ECMO for acute heart failure in adults should take the following actions.

·      Inform the clinical governance leads in their NHS trusts.

·      Ensure that patients and their carers understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information. In addition, the use of NICE’s information for the public [[URL to be added at publication]] is recommended.

·      Submit data on all adults undergoing ECMO for acute heart failure to the international Extracorporeal Life Support Organization register.

1.3                  ECMO for acute heart failure in adults should only be carried out by clinical teams with specific training and expertise in the procedure.

1.4                  NICE encourages further research into ECMO for acute heart failure. This should include clear documentation of patient selection and indications for the use of ECMO. Outcome measures should include survival, quality of life and neurological status.

 

2                      Indications and current treatments

 

2.1                  Heart failure is a complex clinical syndrome of symptoms and signs that occurs when the efficiency of the heart as a pump is impaired. It can lead to reduced blood flow to the body tissues and increased filling pressure in the heart, which causes congestion and oedema in the lungs (causing breathlessness) and/or the body (causing swelling of the legs). Other symptoms include reduced exercise tolerance, fatigue and malaise.

2.2                  Treatment for acute heart failure (specifically, sudden significant deterioration in people with known cardiac dysfunction or new onset of symptoms in people without previous cardiac dysfunction) involves pharmacological therapies, including diuretics and inotropic agents. Invasive therapies include electrophysiological interventions such as pacemakers or implantable cardioverter-defibrillators, revascularisation procedures such as percutaneous coronary intervention, valve replacement or repair, and temporary use of intra-aortic balloon pumps or ventricular assist devices.

 

3                      The procedure

 

3.1                  Extracorporeal membrane oxygenation (ECMO) for acute heart failure in adults can be used after heart surgery to assist in the transition from cardiopulmonary bypass to ventilation. It can also be used as a bridge to myocardial recovery, cardiac transplantation or implantation of a left ventricular assist device.

3.2                  There are two types of ECMO – venovenous and venoarterial: for acute heart failure in adults the venoarterial method is used.   Blood is withdrawn via the venous system (usually the femoral vein or right atrium) and pumped through an oxygenator, where gas exchange of oxygen and carbon dioxide takes place. It is then returned to the arterial system (usually the femoral artery or ascending aorta). Patients are given a continuous infusion of an anticoagulant, usually heparin, to prevent blood clotting in the external system. For patients with renal insufficiency, a haemofiltration unit may be integrated into the circuit.

 

 

4                      Efficacy

 

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview [add URL].

4.1                  A register including 3065 adult cardiac failure and cardiopulmonary resuscitation (CPR) patients reported survival to discharge or transfer in 39% (891/2312) of cardiac failure patients and in 27% (207/753) of CPR patients. Four case series of 81 patients (with acute refractory cardiogenic shock), 295 patients (treated by extracorporeal mechanical oxygenation [ECMO] supported CPR), 219 patients (with refractory postcardiotomy cardiogenic shock) and 24 patients (with refractory cardiac arrest included in a case series of 51 patients) reported survival to discharge in 42% (34/81), 27% (79/295), 24% (52/219) and 4% (1/24) of patients respectively.

4.2                  A case series of 47 patients with refractory postcardiotomy cardiogenic shock who were discharged from hospital after ECMO reported an overall survival rate of 59% at 10 years.

4.3                  The case series of 219 patients reported that 4% (8/219) of patients were bridged to a long-term ventricular assist device. Five patients subsequently died, 2 had a successful transplant and 1 was successfully weaned from ECMO. A case series of 70 patients with acute circulatory collapse reported 44% (31/70) of patients were successful bridged to a ventricular assist device (n=16) or directly bridged to heart transplant (n=15). Of the patients bridged to a ventricular assist device, 50% (8/16) were bridged to heart transplant and discharged, and the remaining 8 patients died while on a ventricular assist device. Of the patients who were directly bridged to heart transplant, 4 patients subsequently died. Remaining 56% (39/70) of patients were unsuccessfully bridged (37 patients died; 1 patient underwent an implantation of cardioverter defibrillator and 1 patient was in a vegetative stage after ECMO removal).

4.4                  The case series of 81 patients (28 patients available for quality of life evaluation) reported a significant difference in physical component (p=0.0001), general health (p=0.01) and vitality (p=0.02) domains of SF-36 quality of life scores in 14 patients who were followed up for a longer time period (higher scores in patients followed up for 325 days or more).

4.5                  The specialist advisers listed key efficacy outcomes as survival (specifying survival to discharge from hospital, at 28 days, at 6 months, to definitive therapy, and long term), successful bridge to recovery, functional capacity and quality of life in the long term.

 

 

5                      Safety

 

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview [add URL].

5.1                  Death during extracorporeal mechanical oxygenation (ECMO) support was reported in 40% (52/131) of patients in a case series of 131 patients with cardiogenic shock; in ‘most cases’ this was because of multi-organ failure or sepsis.

5.2                  Death within 30 days was reported in 76% (167/219) of patients in the case series of 219 patients with refractory postcardiotomy cardiogenic shock; the main cause of death was low cardiac output syndrome secondary to refractory myocardial failure.

5.3                  Intracranial haemorrhage was reported in 2% of patients in the register reporting on 2312 cardiac failure patients (absolute numbers not reported; timing unclear).

5.4                  Stroke was reported in 9% (7/81) of patients in the case series of 81 patients (timing unclear).

5.5                  Femoral artery perforation (leading to uncontrollable bleeding and subsequent death) was reported in 2 patients in the case series of 131 patients.

5.6                  Lower limb ischaemia was reported in 13% (28/219) of patients in the case series of 219 patients; fasciotomy for severe leg ischaemia was needed in 6% (13/219) of patients (timing unclear).

5.7                  Deep vein thrombosis (during hospitalisation) was reported in 15% (4/27) of the 27 patients with severe cardiogenic shock in the case series of 51 patients.

5.8                  Ventilator-associated pneumonia (1 or more episode) was reported in 49% (40/81) of patients, surgical wound infections in 17% (14/81) of patients, bacteraemia in 14% (11/81) of patients, and catheter-related infections in 6% (5/81) of patients in the case series of 81 patients (timing unclear).

5.9                  Mechanical complications, including oxygenator failure (15%; 36% of these patients survived), cannula problems (4%; 27% survived), tubing rupture (less than 1%; none survived) and pump malfunction (less than 1%; 28% survived), were reported in cardiac failure patients (n=2312) included in the register of  patients treated by ECMO (absolute numbers not reported). Clots in the ECMO circuit were reported in 19% (56/295) of patients and air embolus in 2% (5/295) of patients in the case series of 295 patients.

5.10               The specialist advisers listed the following additional adverse events reported in literature: cannulation-related complications (misplacement and arterial rupture) and anoxic neurological complications. They listed the following anecdotal adverse events: intrathoracic bleeding, left ventricular thrombus formation and acute pulmonary injury.

 

 

6                      Committee comments

 

6.1                   The Committee noted that the interpretation of evidence on extracorporeal membrane oxygenation (ECMO) for acute heart failure in adults was complicated by the heterogeneity of indications in published reports.

6.2                  The Committee recognised that ECMO provides only short-term support so it is important to have a strategy for management after ECMO before using the procedure. The Committee was advised that patient selection is fundamental to the success of ECMO and that the procedure should only be used in patients whose condition is refractory to other treatments, and who have acute heart failure that is likely to recover spontaneously (for example myocarditis) or for whom there is a clear plan for subsequent intervention (such as cardiac transplantation). The Committee was also advised that ECMO may need to be withdrawn for patients whose heart failure either will not recover or is not suitable for further treatment.

6.3                  The Committee noted that the technology for this procedure is evolving.

 

 

7                      Further information

 

7.1                  For related NICE guidance see the NICE website.

 

_{Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.}

 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}

 

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

November 2013