Recommendation ID
IPG421/1
Question
NICE encourages further research into transcatheter aortic valve implantation (TAVI) for aortic stenosis. In particular, NICE encourages clinicians to enter all suitable patients into the UK TAVI trial. Information from research trials that will be useful for future guidance includes patient selection criteria and comparisons between TAVI and surgical aortic valve replacement (SAVR) in patients who would be suitable for either procedure. Outcomes should include incidence of stroke and other adverse events, symptom relief, quality of life, occurrence of aortic regurgitation, and valve durability in the short and long term.
Any explanatory notes
(if applicable)
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 for whom surgical aortic valve replacement (SAVR) is considered suitable but to pose a high risk (see sections 1.5, 1.6 and 2.1.3 of the guidance) 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 of the guidance) 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.

Source guidance details

Comes from guidance
Transcatheter aortic valve implantation for aortic stenosis
Number
IPG421
Date issued
March 2012

Other details

Is this a recommendation for the use of a technology only in the context of research? Yes  
Is it a recommendation that suggests collection of data or the establishment of a register?   No