Guidance
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 11 sources, which was discussed by the committee. The evidence included 1 systematic review, 3 non-randomised comparative studies (1 of which was included in the systematic review), 2 registry reports, 1 single-arm trial (also included in the systematic review), 1 cohort study, 1 case series and 2 case reports. 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, improved quality of life, reduced hospital admissions related to heart failure and improved survival.
3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, damage to adjacent structures and device embolisation.
3.4 Patient commentary was sought but none was received.
Committee comments
3.5 The committee was informed that this procedure:
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may not be suitable for people with severe tricuspid annular dilatation when the leaflets of the tricuspid valve cannot be brought together
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can be used for people with pacing leads.
3.6 The committee noted that:
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there is more than 1 device available for the procedure
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the procedure is indicated for people with severe, symptomatic tricuspid regurgitation when conventional surgery poses too high a risk.
3.7 The committee encourages the establishment of a registry for this procedure, or its inclusion into an existing registry.
ISBN: 978-1-4731-4677-8