1.1 The evidence on percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI raises no major safety concerns other than those associated with the TAVI procedure. However, the evidence on efficacy for preventing TAVI-related stroke is inconclusive. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
1.2 Clinicians wishing to do percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI should:
Inform the clinical governance leads in their NHS trusts.
Ensure that patients and their carers understand the procedure's safety and efficacy, as well as any uncertainties about these. Provide them with clear written information to support shared decision making. In addition, the use of NICE's information for the public is recommended.
Details of all patients should be entered into the UK TAVI registry.
1.3 Patient selection for this procedure should be done by the multidisciplinary team that is considering the suitability of TAVI.
1.4 This procedure should only be done in specialised centres, and only by clinicians and teams with specific training and experience in complex endovascular interventions. Centres doing this procedure should have both cardiac and vascular surgical support for the emergency treatment of complications and subsequent patient care.
1.5 NICE encourages further research on percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI. This should include details of patient selection and risk stratification for TAVI-related stroke. NICE may update the guidance on publication of further evidence.