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 3 systematic reviews and meta-analyses, 1 randomised controlled trial, 3 non-randomised comparative studies, 2 case series, and a review of the MAUDE database and the Ethicon complaint database. It is presented in the summary of key evidence section in the interventional procedures overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: improved quality of life, reduced reflux symptoms and reduced need for medical therapy for reflux.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain, dysphagia, oesophageal erosion and the need for device explantation and reoperation.
3.4 Two commentaries from people who have had this procedure and 1 patient organisation submission for this procedure were discussed by the committee.
Committee comments
3.5 The committee noted that the devices are intended to remain in place for life, so there should be arrangements to report complications in the long term.
3.6 The committee noted that this procedure has evolved, and the incidence of dysphagia and oesophageal spasm has reduced, over time.
3.7 The committee was informed that an MRI-compatible device is available.
3.8 The committee was informed that early postoperative management is important, including managing diet and encouraging normal eating after surgery.
ISBN: 978-1-4731-4935-9