What has NICE said?

What has NICE said?

Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) is safe enough and works well enough for use in the NHS for patients with a failing aortic bioprosthetic valve for whom open heart surgery isn't an option.

There is not much good evidence about how well this procedure works or how safe it is for patients with a failing aortic bioprosthetic valve for whom open heart surgery is an option but poses a high risk. It should only be used in such patients if extra care is taken to explain the risks and extra steps are put in place to record and review what happens.

There is not enough evidence to be sure about how well this procedure works or how safe it is for patients with a failing aortic bioprosthetic valve for whom open heart surgery to replace the valve is an option and doesn't pose a high risk. For this reason, it should only be done in such patients as part of a research study.

NICE is asking health professionals to send information about everyone who has the procedure and what happens to them afterwards to the UK Central Cardiac Audit Database, so that the safety of the procedure and/or how well it works can be checked over time.

What does this mean for me?

If you have a failing aortic bioprosthetic valve and open heart surgery isn't an option, your health professional should fully explain what is involved in having this procedure and discuss the possible benefits and risks with you. You should also be told how to find more information about the procedure. All of this should happen before you decide whether you want to have this procedure or not. Your health professional should ask you if details of your procedure can be collected.

If you have a failing aortic bioprosthetic valve and open heart surgery is an option but poses a high risk, your health professional should fully explain what is involved in having this procedure and discuss the possible benefits and risks with you. In particular, they should explain the uncertainty about the evidence on how likely it is to improve your symptoms and possible side effects. You should also be told how to find more information about the procedure. You should only be asked if you want to agree to this procedure after having this discussion. Your health professional should ask you if details of your procedure can be collected.

If you have a failing aortic bioprosthetic valve and open heart surgery is an option and doesn't pose a high risk, your health professional can only offer you this procedure as part of a research study. Details of your procedure will be collected.

Other comments from NICE

NICE said that most of the evidence on the use of ViV-TAVI for patients with a failing aortic bioprosthetic valve comes from older patients at high risk from open heart surgery. It also noted that there is no published evidence on the use of ViV-TAVI in patients considered at low risk from open heart surgery to replace the valve.

NICE said that patients with small bioprosthetic valves and those in whom the main problem was narrowing (stenosis), rather than a leaking, of the existing valve were less likely to survive the procedure.

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