For people with severe and symptomatic tricuspid regurgitation, evidence on the efficacy of transcatheter tricuspid valve leaflet repair is limited in quantity and quality. Evidence on its safety shows there are serious but well-recognised complications. Therefore, for these people, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
For people with mild or moderate tricuspid regurgitation, evidence on the safety and efficacy of transcatheter tricuspid valve leaflet repair is inadequate in quantity and quality. Therefore, for these people, this procedure should only be used in the context of research. Find out what only in research means on the NICE interventional procedures guidance page.
Clinicians wanting to do transcatheter tricuspid valve leaflet repair for people with severe and symptomatic tricuspid regurgitation should:
Inform the clinical governance leads in their healthcare organisation.
Give patients (and their families and carers as appropriate) clear written information to support shared decision making, including NICE's information for the public.
Ensure that patients (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Audit and review clinical outcomes of all patients having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedures outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for every patient having this procedure.
Regularly review data on outcomes and safety for this procedure.
The procedure should only be done in specialised centres with experience of the interventional management of tricuspid regurgitation. There should be immediate, onsite access to cardiac and vascular surgery.
Further research should include details of patient selection, including the type and severity of tricuspid regurgitation.