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 systematic reviews, 2 randomised controlled trials (1 is also included in the systematic review and the other compares 2 different healthcare settings), 1 non-randomised comparative study, 3 cohort studies, 2 case series, 1 case report and 1 review of adverse events reported on the US Food and Drug Administration Manufacturer and User Facility Device Experience database. 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.