Surgical insertion of a catheter-based left ventricular microaxial flow pump for cardiogenic shock

Acute heart failure is a complex clinical syndrome of signs and symptoms 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, potentially leading to organ failure and death. It has multiple causes, including:

• heart attack

• chronic heart failure

• sudden heart valve failure

• cardiac arrhythmias, inflammation of the heart muscle

• blood clots in the lungs

• drug overdoses and poisoning.
  
  It can also happen after open heart surgery (postcardiotomy cardiogenic shock).

Managing cardiogenic shock includes:

• medicines such as diuretics and inotropic agents

• mechanical circulatory support such as intra-aortic balloon pumps, venoarterial extracorporeal membrane oxygenation and ventricular assist devices.
  
  Depending on the aetiology of the acute heart failure, once the initial symptoms of cardiogenic shock have been stabilised, interventions to reverse the underlying cause may be used. These include revascularisation using bypass surgery or percutaneous coronary intervention. If symptoms do not improve, a heart transplant or an implanted durable left ventricular assist device may be options.

The procedure is used to provide temporary short-term cardiac support to people with cardiogenic shock when symptoms have not responded to other forms of treatment. It is used if there is the potential for the heart to recover, or for bridging to a heart transplant or implantation of a durable left ventricular assist device. The procedure does not need a sternotomy, so it may be less invasive than other mechanical circulatory support systems and allows earlier mobilisation. Surgical insertion enables a larger pump to be used than can be inserted percutaneously. A larger pump has a higher flow rate, which is suitable for people who need more cardiac support. It can be used for longer durations than other systems.

NICE did a rapid review of the literature on the efficacy and safety of this procedure. The prioritised evidence included 1 systematic review and meta-analysis, 1 prospective multicentre observational study, 8 retrospective observational studies and a retrospective analysis of safety data from the US Food and Drug Administration Manufacturer and User Facility Device Experience database. It is presented in the summary of key evidence section in the interventional procedures assessment report. Other relevant literature is in the appendix of the assessment report. Two different devices were used in the studies informing this guidance.

The professional experts and the committee considered the key efficacy outcomes to be:

• short-term survival

• bridging to heart transplant or durable left ventricular assist device

• longer-term outcomes, including survival and health-related quality of life.

The professional experts and the committee considered the key safety outcomes to be:

• pain

• bleeding

• haemolysis

• stroke

• pump failure

• limb ischaemia

• acute kidney injury

• sepsis

• cardiac perforation.

Three commentaries from people who had a catheter-based left ventricular microaxial flow pump for cardiogenic shock inserted were discussed by the committee.

There are ongoing studies for this procedure.

The technology for this procedure has developed since the first studies were published, and newer models of the device are available.

This procedure has also been done after cardiac surgery with an open chest, but there is limited evidence for this indication.

Centres that do this procedure should have a bleeding management protocol in place.

The incidence of heart failure increases with age and it is more common in men.

There is a lack of evidence in women.

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

People with heart failure may be covered by the Equality Act 2010 under disability if their heart failure has had, or is likely to have, a substantial adverse impact on their usual day-to-day activities for over 12 months. People with heart failure often have multiple comorbidities.