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The National Institute of Clinical Excellence (NICE) recently published (March 2012) their interventional procedural guidance (421) for transcatheter aortic valve implantation (TAVI) for aortic stenosis.1 This document replaced the previous guidance 266 which was issued in June 2008.2
The recent NICE guidance deserves comment on a number of fronts.
The timing of delivery of the guidance is problematic. The 2-year outcomes of the only randomised trial (the Partner US trial) with this technology was publicly presented, and simultaneously published in the New England Journal of Medicine on 26th March 2012.3 ,4 To decide the content of the guidance and publish it without the content of these two landmark papers appears a strange decision. ‘Process’ should surely fall into line with the ‘best’ recommendations for patients. It is difficult to understand why the two publications could not be more closely aligned as it is clear that the dates of publication of the 2-year Partner data were known well in advance.
If we now turn to the specifics of the guidance, it is worth just reviewing the data on which it is based. The world literature is split between one randomised clinical trial (the Partner US trial) and a myriad of single and multicentre registries (either independent or industry sponsored). The guidance has chosen to concentrate on the SOURCE Registry5 and the UK National Registry.6 The reasons for this are never explained or justified. The SOURCE registry is a multicentre, company sponsored, single-device registry (the Edwards Sapien first-generation valve). The UK TAVI Registry is a multidevice, multicentre non-sponsored Registry.
The main change in the guidance was …
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