Transcatheter tricuspid valve implantation can be used in the NHS during the evidence generation period as an option to treat symptomatic severe tricuspid regurgitation when open surgical tricuspid valve repair or replacement is high risk, and transcatheter tricuspid valve repair is unsuitable. There must be enhanced informed consent and auditing of outcomes.
More research is needed on transcatheter tricuspid valve implantation to treat symptomatic severe tricuspid regurgitation before it can be used in the NHS when open surgical tricuspid valve repair or replacement is not high risk, or transcatheter tricuspid valve repair is suitable.
This procedure should only be done as part of formal research and a research ethics committee needs to have approved its use.
When open-heart surgery is high risk, and transcatheter valve repair is unsuitable
There are uncertainties around the safety and efficacy of this procedure. It can be used if needed while more evidence is generated.
After this, this guidance will be reviewed and the recommendations may change.
Healthcare professionals do not have to offer this procedure and should always discuss the available options with the person with tricuspid regurgitation before a joint decision is made.
Hospital trusts will have their own policies on funding procedures and monitoring results. NHS England may also have policies on funding of procedures.
Enhanced informed consent
Because there are uncertainties about the procedure's safety and efficacy, there must be an emphasis on informed consent. Healthcare professionals must make sure that people (and their families and carers as appropriate) understand the uncertainty and lack of evidence around a procedure's safety and efficacy using NICE's advice on shared decision making and NICE's information for the public. Healthcare professionals must also inform the clinical governance leads in their organisation if they want to do the procedure.
Auditing of outcomes
Healthcare professionals doing this procedure should collect data on safety and outcomes of the procedure. Enter details about everyone having this procedure into the National Institute for Cardiovascular Outcomes Research transcatheter mitral and tricuspid valve registry. Regularly review the data on outcomes and safety.
Who should be involved with the procedure
Patient selection should be done by a multidisciplinary team. This procedure should only be done in centres specialised in medical and interventional management of tricuspid regurgitation, where all available treatment options can be offered.
When open-heart surgery is not high risk, or transcatheter valve repair is suitable
There is not enough evidence to know if this procedure is safe and effective when surgery or transcatheter tricuspid valve repair is a suitable treatment option. Transcatheter tricuspid valve implantation for symptomatic severe tricuspid regurgitation should only be done as part of formal research in these groups.
Auditing of outcomes
Healthcare professionals doing this procedure should collect data on safety and outcomes of the procedure. Enter details about everyone having this procedure into the National Institute for Cardiovascular Outcomes Research transcatheter mitral and tricuspid valve registry. Regularly review the data on outcomes and safety.
Who should be involved with the procedure
Patient selection should be done by a multidisciplinary team. This procedure should only be done in centres specialised in medical and interventional management of tricuspid regurgitation, where all available treatment options can be offered.
Evidence generation and research is needed on:
patient selection, including aetiology of the tricuspid regurgitation
device and technique used for the procedure
longer-term safety outcomes including bleeding, paravalvular leak and the need for pacemaker implantation
longer-term efficacy outcomes including quality of life, heart failure related hospital admissions, and survival.
There is some high-quality evidence showing the procedure reduces tricuspid regurgitation and improves quality of life in the short term, compared with medicines. But there is a risk of bleeding during and after the procedure and some people need a permanent pacemaker implanted after the procedure. There is a lack of longer-term data, which is needed because the durability of the valve replacement is unknown. For some people, open surgical tricuspid valve repair or replacement is too high risk and transcatheter techniques to repair the valve are unsuitable. For these people, the benefits outweigh the risks because there are no other options, so transcatheter tricuspid valve implantation can be used as a treatment option while more evidence is generated on longer-term outcomes.
For some people, open surgical tricuspid valve repair or replacement, or transcatheter tricuspid valve repair, are suitable options. For these people, it is unclear whether the benefits of this procedure outweigh the risks. So, more research is needed in these groups.