1.1
Surgical 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.
1 Recommendation
What this means in practice
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
Patient selection should be done by a multidisciplinary team. This procedure should only be done in centres that specialise in managing cardiogenic shock and by healthcare professionals with specific training in this procedure.
What evidence generation is needed
Healthcare professionals must collect data specifically around the safety and efficacy of this procedure.
This includes:
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patient selection
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the technique used, including duration
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short- and long-term complication rates
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short- and long-term survival outcomes
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quality of life.
Why the committee made this recommendation
There is no evidence from randomised controlled trials for this procedure. There is evidence from a high-quality randomised controlled trial on percutaneous insertion of a catheter-based left ventricular microaxial flow pump. But it is unclear if the benefit seen in this study would also apply to people who need surgical insertion of a left ventricular microaxial flow pump. Results from observational studies are inconsistent but suggest that the procedure may improve survival for people with cardiogenic shock. It may particularly benefit people who are waiting for a heart transplant.
The evidence shows that the procedure may be associated with complications, which can be serious. But there are limited treatment options and this group of people need a high level of cardiac support. So, the procedure can be used as an option in the NHS while more evidence is generated.