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 12 sources, which was discussed by the committee. The evidence included 2 meta-analyses, 3 single-arm trials (1 trial included with its sub-study), 1 safety database review, 1 prospective non-randomised comparative study, 2 retrospective comparative studies, 1 prospective registry, 1 sub-set of the prospective registry and 1 case report. The evidence is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.