The UK’s National Institute for Health and Clinical Excellence (NICE) has updated its guidance for the National Health Service (NHS) on transcatheter aortic valve implantation (TAVI) procedures.
The guidance published on 28 March updates and replaces previous guidance from 2008. The main updates are recommendations on the use of TAVI for people who would be considered unsuitable for open heart surgery (e.g. because of poor health) and on when to consider TAVI as an option for people who could have the more invasive option instead. NICE did not advise on the use of TAVI for these patient groups in 2008 because there was insufficient evidence at the time. Specifically, the new guidance advises the following for people with aortic stenosis:
- If open-heart surgery is not an option (e.g. because of poor health): Specialists could consider performing TAVI routinely, providing that they ensure these patients understand what would be involved and agree to the treatment before giving their consent, and that they monitor the results. NICE calls this “normal arrangements” for clinical governance, consent and audit. NICE did not include recommendations for this group in 2008.
- If open-heart surgery is an option, but would carry a high risk of serious complications or death: This is the only group of patients that NICE’s 2008 guidance focused on. NICE still advises specialists to consider TAVI as a treatment option providing they take extra steps for governance, consent, and data collection or research; including for patients to be made fully aware of its uncertainties and risks before giving their consent, and for there to be “special arrangements” in place for monitoring what happens to patient in the long-term after the procedure. Also, the updated guidance encourages specialists to enter suitable patients in the UK TAVI trial, a research study led by the University of Leicester.
- If open-heart surgery is an option and would not have a high risk of serious complications: Specialists should only consider performing TAVI as part of a structured clinical trial. This is because there is not enough evidence to show that TAVI works better than the open-heart method for this group. NICE did not include recommendations for this group in 2008.
Professor Bruce Campbell, chair of the independent committee that develops NICE’s interventional procedures guidance said: “Current evidence on the safety of TAVI for aortic stenosis shows there are serious but well-recognised complications associated with it. Considering TAVI as a treatment option means balancing these issues against the risk of serious complications if the patients were to have the open heart surgery to replace their narrowed aortic valves. Possible benefits of TAVI could include fewer complications for patients who are at high risk from open heart surgery, quicker recovery and fewer readmissions to hospital. TAVI seems to work well in the short term, with good results for patients during the first year.
“However, NICE recognises that TAVI is a technically challenging procedure and so advises it should only be performed by clinical teams with special expertise in interventional cardiology. NICE also encourages further research, through the UK TAVI trial and the UK Central Cardiac Audit Database, so that more can be learnt about its place in treating patients who would be suitable for surgical aortic valve replacement. Also, we would like to know how well the aortic valves inserted by TAVI work in the long term.”
NICE does not consider cost in this type of guidance. NHS bodies continue to decide locally whether or not to offer the procedure.
Also, this type of NICE guidance does not evaluate the health technologies that may be used in the procedures (e.g. specific brands of artificial aortic valves): the guidance investigates the safety and efficacy of the procedure only.