NICE has updated its guidance for the NHS on transcatheter aortic valve implantation (TAVI), which involves replacing a narrowed aortic valve with an artificial one. This is inserted into the patient’s heart through a catheter. It is an alternative to openheart surgery in which the aortic valve is replaced by opening up the chest. TAVI could benefit certain people who have aortic stenosis; a potentially fatal condition in which the aortic valve becomes narrowed, making blood flow more difficult. Te guidance updates and replaces previous guidance from 2008. Specifically, the new guidance advises the following for people with aortic stenosis:
- If open-heart surgery is not an option (eg. 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 afer 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.