Percutaneous insertion of a catheter-based left ventricular microaxial flow pump can be used in the NHS during the evidence generation period as an option to manage cardiogenic shock. There must be enhanced informed consent and auditing of outcomes.
There are uncertainties around the safety and efficacy of this procedure. It can be used if needed while more evidence is generated.
After this, NICE will review this guidance and the recommendation may change.
Healthcare professionals do not have to offer this procedure and should always discuss the available options with the person with cardiogenic shock (and their family and carers as appropriate) before a joint decision is made, if possible.
Hospital trusts will have their own policies on funding procedures and monitoring results. NHS England may also have policies on funding of procedures.
Enhanced informed consent
Because there are uncertainties about the procedure's safety and efficacy, there must be an emphasis on informed consent. Healthcare professionals must make sure that people (and their families and carers as appropriate) understand the uncertainty and lack of evidence around a procedure's safety and efficacy using NICE's advice on shared decision making and NICE's information for the public. Healthcare professionals must also inform the clinical governance leads in their organisation if they want to do the procedure.
Auditing of outcomes
Healthcare professionals doing this procedure should collect data on safety and outcomes of the procedure. Enter details about everyone having this procedure into an appropriate registry. If there is no data collection method already available, use NICE's interventional procedure outcomes audit tool. Regularly review the data on outcomes and safety.
Who should be involved with the procedure
This procedure should only be done in primary percutaneous coronary intervention centres with on-site intensive care expertise and by healthcare professionals with specific training in this procedure.
Healthcare professionals must collect data specifically around the safety and efficacy of this procedure.
This includes:
patient selection
the technique used, including device and access site
short- and long-term complication rates
short- and long-term survival outcomes
quality of life.
Results from a high-quality randomised controlled trial suggest that this procedure improves survival compared with standard care alone in a subgroup of people with cardiogenic shock associated with heart attack. The trial had a lot of very specific requirements about who could take part, which would be challenging to use in practice. More evidence is needed to know if the benefit observed in this subgroup will also apply to the broader cardiogenic shock population. There is also evidence from several large retrospective observational studies, but the populations in these varied and the efficacy results are inconsistent.
The evidence shows that the procedure may be associated with complications such as bleeding, which can be serious. But because there are limited treatment options for people with cardiogenic shock, the procedure can be used as an option in the NHS while more evidence is generated.