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 10 sources, which was discussed by the committee. The evidence included 2 systematic reviews (1 of which was done as part of a health technology assessment), 2 randomised controlled trials, 4 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: improvement in reflux symptoms, improvement in quality of life, decreased medication use, and rate of reintervention.
3.3 The professional experts and the committee considered the key safety outcomes to be: oesophageal perforation, pleural effusion, pain, and bleeding.
3.4 Patient commentary was sought but none was received.
Committee comments
3.5 The committee noted that there were several different devices available to do this procedure and techniques varied between devices. Most of the evidence came from a single device.
3.6 The committee was informed that some of the anchors used in this procedure may fall out over time.
3.7 This procedure was used in a wide variety of patient subgroups and it was unclear whether some subgroups may benefit more than others.
3.8 The committee noted that although complications were infrequent, these could be serious, such as oesophageal perforation.
ISBN: 978-1-4731-5051-5