June 25th 2008

Following a period of review and consultation with the relevant specialist societies, NICE have today issued preliminary guidance on the application of transcatheter aortic valve implantation for aortic stenosis. Full details are available via the NICE website
and PDF copies of the summary documents for clinicians and patients are available here.

Key points include:
• NICE supports the use of the intervention for patients in England and Wales with aortic stenosis who are at high risk for conventional surgery.
• Clinicians wishing to use this procedure should do so only with special arrangements for clinical governance, consent and for audit or research.
• Patient selection should be carried out by a multidisciplinary team including an interventional cardiologist, a cardiac surgeon and a cardiac anaesthetist.
• Units undertaking this procedure should have both cardiac and vascular surgical support for emergency treatment of complications.
• Ensure that patients understand the uncertainty about the procedure’s long-term efficacy and its risks, which include death and the potential need for emergency cardiac surgery.
• Clinicians should enter details of all patients undergoing transcatheter aortic valve implantation into a national database to allow ongoing evaluation of the procedure. BCIS is currently working with NICE and CCAD to develop an appropriate mechanism.
• NICE did not distinguish between the two currently available devices (Edwards-Sapien & CoreValve).
• Cost-effectiveness analyses have not yet been considered by NICE, but it is hoped that their positive preliminary comments will encourage national funding via PCTs and local networks.

Dr Bernard Prendergast
BCIS Honorary Secretary