3 Committee considerations

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 6 sources, which was discussed by the committee. The evidence included 1 systematic review, 2 single-arm trials (1 of which was also included in the systematic review), and 3 case series (2 of which were also included in the systematic review). 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 and damage to adjacent structures, including the right coronary artery.

3.4

Patient commentary was sought but none was received.

Committee comments

3.5

The committee was informed that, in future, this procedure may be used in combination with or after procedures on the mitral valve.

3.6

The committee noted that the procedure is indicated for people with severe, symptomatic tricuspid regurgitation for whom conventional surgery is too high risk.

3.7

The committee encourages the establishment of a registry for this procedure, or its inclusion into an existing registry.

ISBN: 978-1-4731-4638-9