NICE in the UK has released a consultation document in relation to the TAVI procedure (Interventional Procedure Guidance).
Publication of the final guidance, which will replace the guidance from the 2012, is expected in July 2017. In 2012 evidence for inoperable patients was considered adequate.
The following recommendations were made in the current (from 2012) IPG for TAVI:
- "Evidence on the safety of transcatheter aortic valve implantation (TAVI) for aortic stenosis shows the potential for serious but well-recognised complications
- For patients with aortic stenosis who are considered to be unsuitable for surgical aortic valve replacement (SAVR; see sections 1.6 and 2.1.3) the evidence on the efficacy of TAVI is adequate. For these patients, TAVI may be used with normal arrangements for clinical governance, consent and audit. Details of all patients should be entered into the UK Central Cardiac Audit Database.
- For patients with aortic stenosis for whom SAVR is considered suitable but to pose a high risk (see sections 1.5, 1.6 and 2.1.3) the evidence on the efficacy of TAVI is inadequate. For these patients TAVI should only be used with special arrangements for clinical governance, consent and data collection or research. NICE encourages clinicians to enter suitable patients into the UK TAVI trial. In addition, details of all patients should be entered into the UK Central Cardiac Audit Database.
- For patients with aortic stenosis for whom SAVR is considered suitable and not to pose a high risk (see sections 1.6 and 2.1.3) the evidence on the efficacy of TAVI is inadequate. For these patients TAVI should only be used in the context of research. NICE encourages clinicians to enter suitable patients into the UK TAVI trial. In addition, details of all patients should be entered into the UK Central Cardiac Audit Database."
Consultation document includes information about considered evidence of efficacy and safety, although the interpretation of evidence by the Interventional Procedures Advisory Committee is not clear at the moment.
The most interesting development is in relation to the operable high and intermediate risk patient groups.
Access the consultation documents here.