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 7 sources, which was discussed by the committee. The evidence included 1 single-arm pivotal study, 2 single-arm pilot studies, and 4 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. Additional documentation in confidence provided by a company was also considered by the committee.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: improvement in limb perfusion and wound healing, reduction in major amputation, and improvement in quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain, bleeding, infection, worsening of perfusion, and steal syndrome.
3.4 Three commentaries from people who have had this procedure were discussed by the committee.
3.5 Some patients needed both planned and unplanned reinterventions. The reinterventions might not have been related to this procedure.
3.6 The committee was informed that patient selection and postprocedural surveillance are important, and that patients should be followed up for life.
3.7 The committee was informed that this is a challenging procedure, and that it should only be done by clinicians with specific training and experience in this technique.
3.8 There are different techniques and devices used, which might have different efficacy and safety profiles. The committee was informed that there is currently only 1 device with regulatory approval for use in the UK.
3.9 The committee encourages data entry into a registry that captures the technique used.