Transcatheter aortic valve implantation (TAVI) can be used in the NHS while more evidence is generated to treat native aortic valve regurgitation when surgical aortic valve replacement (SAVR) is not suitable or is high risk. It can only be used with special arrangements for clinical governance, consent, and audit or research.
Clinicians wanting to do TAVI when SAVR is not suitable or is high risk should:
Inform the clinical governance leads in their healthcare organisation.
Ensure that people (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Take account of NICE's advice on shared decision making, including NICE's information for the public.
Audit and review clinical outcomes of everyone having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.
Regularly review data on outcomes and safety for this procedure.
More research is needed on TAVI for native aortic valve regurgitation when SAVR is suitable and is not high risk before it can be used in the NHS.
This procedure should only be done as part of a formal research study and a research ethics committee needs to have approved its use.
Patient selection should be done by an experienced multidisciplinary team, which must include:
interventional cardiologists experienced in the procedure
cardiac surgeons
an expert in cardiac imaging, and
when appropriate, a cardiac anaesthetist and a specialist in medicine for older people.
The multidisciplinary team should determine the risk level for each patient and the TAVI valve most suitable for them.
TAVI is a technically challenging procedure that should only be done in specialised centres and only by teams with specific training and experience in complex endovascular interventions. There should be both cardiac and vascular surgical support for the emergency treatment of complications from TAVI and subsequent care.
Enter details about everyone having TAVI for native aortic valve regurgitation into the UK TAVI registry, managed by the National Institute for Cardiovascular Outcomes Research. Contact [email protected] for details.
Further evidence generation and research should be in the form of suitably powered randomised controlled trials or patient registries across all risk categories. The trials should report details of:
patient selection
comparisons between TAVI and SAVR or medical treatment
comparisons between different TAVI prosthetic aortic valves
long-term outcomes, including:
valve durability and reintervention rates
the need for a second TAVI valve-in-valve implantation
safety outcomes, including embolisation, stroke and myocardial infarction.
When SAVR is not suitable or is high risk, evidence on the procedure shows well-recognised safety concerns. Evidence on efficacy is limited in quality and comes mainly from short-term, small observational studies or registries. So, the procedure can only be used with special arrangements for clinical governance, consent, and audit or research.
When SAVR is suitable and is not high risk, there is not enough evidence on the safety and efficacy of the procedure. So, it should only be used in research.