Transcatheter tricuspid valve leaflet repair for tricuspid regurgitation
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3 Committee considerations
The evidence
3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 1 systematic review, 3 non-randomised comparative studies, 2 registry reports, 1 single-arm trial, 1 case series and 1 case report. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: reduced tricuspid regurgitation, reduced signs and symptoms of right-sided heart failure, and improved quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, damage to adjacent structures and device embolisation.
Committee comments
3.4 The committee was informed that this procedure:
may not be suitable for people with severe tricuspid annular dilatation when the leaflets of the tricuspid valve cannot be brought together
can be used for people with pacing leads.
3.5 The committee noted that:
there is more than 1 device available for the procedure
the procedure is indicated for people with severe, symptomatic tricuspid regurgitation when conventional surgery poses too high a risk.
3.6 The committee encourages the establishment of a registry for this procedure, or its inclusion into an existing registry.
Tom Clutton-Brock
Chair, interventional procedures advisory committee
February 2022
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