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 8 sources, which was discussed by the committee. The evidence included 1 systematic review, 1 prospective registry study, 3 retrospective case series, 1 propensity scored matching cohort study and 2 comparative case series. 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: arteriovenous fistula maturation rate, ease of arteriovenous fistula use, longevity (patency) of arteriovenous fistula, need for reintervention, and quality of life in relation to the arteriovenous fistula.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain, bleeding, haematoma, infection, arterial thrombosis, and subclavian steal syndrome.
3.4 Sixteen commentaries from patients who have had this procedure were discussed by the committee. One patient organisation representing patients who have had this procedure provided submissions and these were also discussed by the committee.
3.5 The committee noted that more than 1 device is available for this procedure.
3.6 The committee heard that the procedure is only used to create a fistula in the forearm.
3.7 It would be helpful if data were collected as part of a registry.
3.8 The committee was informed in patient commentary that the procedure may have a better aesthetic result than a surgically created fistula.