UK NICE Issues Recommendations for Percutaneous Insertion of a Cerebral Protection Device During TAVI

 

June 18, 2019—The United Kingdom's National Institute for Health and Care Excellence (NICE) announced evidence-based recommendations on the percutaneous insertion of a cerebral protection device to prevent cerebral embolism during transcatheter aortic valve implantation (TAVI; also known as transcatheter aortic valve replacement) in adults.

Available online on the NICE website, the recommendations are:

  • 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.
  • Clinicians wishing to do percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI should: (1) Inform the clinical governance leads in their NHS trusts. (2) Ensure that patients and their care providers 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. (3) Details of all patients should be entered into the UK TAVI registry.
  • Patient selection for this procedure should be done by the multidisciplinary team that is considering the suitability of TAVI.
  • This procedure should only be done in specialized centers, and only by clinicians and teams with specific training and experience in complex endovascular interventions. Centers doing this procedure should have both cardiac and vascular surgical support for the emergency treatment of complications and subsequent patient care.
  • 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.

According to the NICE guidance, the evidence review identified three types of cerebral protection devices. One type is a deflector system that covers all three main branches of the aortic arch. The two other types cover the brachiocephalic trunk and the left common carotid artery; one is a filter system and the other is a deflector system.

NICE advised that this guidance will be reviewed again in June 2022.

 

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