How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Interventional procedure overview of transcatheter tricuspid valve leaflet repair for tricuspid regurgitation

    Closed for comments This consultation ended on at   Request commenting lead permission

    Validity and generalisability of the studies

    • No randomised controlled trials were identified.

    • The evidence includes data from North America and Europe.

    • Many of the studies report results from the first people to have the procedure.

    • Results of the early feasibility study may not be applicable to the total population of patients with clinically significant tricuspid regurgitation (Lurz, 2021).

    • There is more than 1 device available and different devices use different mechanisms.

    • The study by Asmarats et al. (2019) used the FORMA device, which is no longer available. The study has been included because it reports longer term data (median follow up of 32 months), but the sample size is small.

    • The definition of procedural success varied between studies.

    • Two non-randomised comparative studies used data from the Tri-Valve registry but they compared it with different populations (Schlotter, 2021, Taramasso, 2019).

    • There is some patient overlap between the studies.

    • Most studies only reported outcomes up to 1 year. The longest median follow up was 32 months, in 1 small case series.