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    4 Committee discussion

    The condition

    4.1

    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

    4.2

    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 new onset of symptoms in people without previous cardiac dysfunction. Treatment involves medicines, including diuretics and inotropic drugs, and invasive treatments such as:

    • electrophysiological intervention 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.

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

    Unmet need

    4.3

    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 and not hours during open heart surgery, allowing the heart time to recover. It aims to improve patient outcomes.

    The evidence

    4.4

    NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 4 systematic reviews, 3 randomised controlled trials, 1 retrospective registry study and 1 single centre retrospective study. 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.

    4.5

    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.

    4.6

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

    4.7

    Patient commentary was sought but none was received.

    Committee comments

    4.8

    The committee noted that VA ECMO should only be done in centres specialised in managing severe acute heart failure and providing VA ECMO.

    4.9

    The committee noted that this is a short-term intervention to stabilise people's conditions and bridge them to further treatment or decisions about their care. Some people will recover, and others will need a heart transplant or long-term mechanical support.

    4.10

    The committee was told that reducing the time to starting VA ECMO is of high importance for better outcomes.

    4.11

    The committee was told that people can be moved from other non-specialised centres to have VA ECMO.

    4.12

    The committee noted the incidence of limb ischaemia but that this has reduced since distal limb perfusion has been in use.

    4.13

    The committee noted that the recommendations in this guidance include the use of ECMO during pregnancy or in the post-partum period.

    Equality considerations

    4.14

    The committee noted that 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 not have access to this intervention.

    4.15

    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).

    4.16

    Acute heart failure in pregnancy is relatively uncommon. Women, trans men and non-binary people who are pregnant and have established chronic conditions such as diabetes or hypertension, or have congenital or acquired heart disease are at greater risk of heart failure. Pregnancy and maternity are protected characteristics under the Equality Act (2010).