3.1 To inform the committee, 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 14 sources, which was discussed by the committee. The evidence included 2 randomised controlled trials (1 of which also had a subgroup analysis published), 1 systematic review, 2 registries, 3 non-randomised comparative studies, 4 case reports and 1 conference abstract that reported safety data, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: clot removal, reduction in post-thrombotic syndrome, patient-reported outcomes including quality of life scores, and reduction in pulmonary embolisation.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: bleeding, haemolysis, vessel damage including stenosis, clot embolisation, and rethrombosis.
3.4 Patient commentary was sought but none was received.
3.5 The committee was informed that this can be a limb-saving procedure for patients with severe acute iliofemoral deep vein thrombosis (DVT).
3.6 There are different devices and techniques used for this procedure.
3.7 Much of the evidence included in the overview is from a device that is no longer on the market.
3.8 Patient selection is important and patients should be assessed by a multidisciplinary team that includes a vascular surgeon, an interventional radiologist and a haematologist.
3.9 The committee was informed that the procedure is likely to have a better outcome when it is done within 14 days of presentation with a DVT.