3.1
To inform the committee, 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 14 sources, which was discussed by the committee. The evidence included 2 randomised controlled trials (1 of which also had a subgroup analysis published), 1 systematic review, 2 registries, 3 non-randomised comparative studies, 4 case reports and 1 conference abstract that reported safety data, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.