3 Committee discussion

The condition

3.1

Acute heart failure is a complex clinical syndrome of symptoms and signs that happen when the efficiency of the heart as a pump is impaired. It can lead to reduced blood flow to the body and increased filling pressures in the heart. Cardiogenic shock is the most severe form of acute heart failure, with short-term mortality between 30% and 50%. It can be caused by a heart attack, heart failure, inflammation of the heart muscle, drug overdoses and poisoning, and blood clots in the lungs. Severe acute heart failure in pregnancy is relatively uncommon but rates are increasing, particularly in the postpartum period.

Current practice

3.2

NICE has published recommendations on diagnosing and managing acute heart failure (see NICE's guideline on acute heart failure: diagnosis and management). Acute heart failure includes sudden significant deterioration in people with known cardiac dysfunction or the new onset of symptoms in people without previous cardiac dysfunction. Treatment involves medicines, including diuretics and inotropes, and invasive treatments such as:

  • electrophysiological interventions such as pacemakers or implantable cardioverter-defibrillators

  • revascularisation procedures such as percutaneous coronary intervention, valve replacement or repair

  • temporary use of intra-aortic balloon pumps or ventricular assist devices.

    Most acute heart failure can be managed with conventional treatment. Only a few people with severe acute heart failure will need venoarterial extracorporeal membrane oxygenation (VA ECMO).

Unmet need

3.3

VA ECMO is a form of extracorporeal life support. It provides cardiac and respiratory support for people with severe acute heart failure that has not responded to other forms of treatment. VA ECMO is used when people have the potential to recover, or as a bridge to having a heart transplant or an implanted left ventricular assist device. Unlike a heart–lung (cardiopulmonary) bypass machine, it tends to be used for days to weeks, not hours during open heart surgery. This allows the heart time to recover. The aim is to improve patient outcomes.

The evidence

3.4

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and a detailed review of the evidence from 14 sources (16 publications), which was discussed by the committee. The evidence included 7 systematic reviews, 3 randomised controlled trials, 1 retrospective registry study, 2 single centre retrospective studies, and 1 review and case series. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

3.5

The professional experts and the committee considered the key efficacy outcomes to be: survival, restoration of organ function, and bridging to recovery, transplant or long-term support.

3.6

The professional experts and the committee considered the key safety outcomes to be: bleeding, leg ischaemia, stroke, infection, kidney failure and circuit-related complications.

3.7

Patient commentary was sought but none was received.

Committee comments

3.8

VA ECMO could be done in centres specialised in managing severe acute heart failure and providing VA ECMO.

3.9

This is a short-term intervention to support people and provide a bridge to further treatment or decisions about their care. Some people will recover, and others will need a heart transplant or long-term mechanical support.

3.10

The committee was told that, for better outcomes, it is very important to start VA ECMO for managing severe acute heart failure as early as possible.

3.11

The committee was told that people:

  • can be transferred to specialist centres for VA ECMO

  • can potentially be transferred on VA ECMO to specialist centres.

3.12

The committee noted that there is a risk of limb ischaemia when the femoral artery is used. But it also noted that this risk has reduced since distal limb perfusion has been in use.

3.13

The recommendations in this guidance include the use of VA ECMO during pregnancy or in the postpartum period.

3.14

The committee was told that a high level of nursing expertise and input from a perfusionist are needed to support people on VA ECMO.

3.15

Some people who had VA ECMO have become organ donors, and their organs have been transplanted.

Equality considerations

3.16

There are few centres in the UK that specialise in managing severe acute heart failure and using VA ECMO. So, people in more rural areas may have to travel large distances or may not have time to access this intervention.

3.17

The prevalence of heart failure slowly increases with age until about 65 years, and then more quickly. Age is a protected characteristic under the Equality Act (2010).

3.18

Acute heart failure in pregnancy is relatively uncommon. Women, trans men and non-binary people who are pregnant are at greater risk of heart failure if they have:

  • established chronic conditions such as diabetes or hypertension, or

  • congenital or acquired heart disease.

    Pregnancy and maternity are protected characteristics under the Equality Act (2010). Women, trans men and non-binary people with severe acute heart failure who are pregnant, or who have recently been pregnant, may need to access this intervention.