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    Interventional procedure overview of superficial venous arterialisation and selective venous occlusion for chronic limb threatening ischaemia in people with no other option for revascularisation

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    Safety summary

    Late revascularisation

    Late revascularisation was done in 4 patients in the superficial venous arterialisation group and 1 in the conservative treatment group in the cohort study of 28 patients (Matzke 1999). Of the 4 patients in the superficial venous arterialisation group, 1 had a successful revascularisation.

    Graft thrombosis

    Graft thrombosis was reported in 6 patients who had superficial venous arterialisation in the cohort study of 60 patients (Djoric 2012).

    Graft thrombosis within 48 hours postoperatively was reported in 17% (2/12) of patients who had superficial venous arterialisation in the cohort study of 36 patients (Djoric 2011).

    Bleeding or haematoma

    Bleeding was reported in 2 patients who had superficial venous arterialisation in the cohort study of 60 patients (Djoric 2012).

    Haematoma because of coagulopathy was reported in 1 patient who had superficial venous arterialisation in the cohort study of 36 patients (Djoric 2011).

    Infection

    Infection of operative incision was reported in 1 patient who had superficial venous arterialisation in the cohort study of 60 patients who CLTI (Djoric 2012).

    Would infection was reported in 2 patients who had superficial venous arterialisation in the cohort study of 36 patients with CLTI (Djoric 2011).

    Swelling

    Leg swelling was reported in 3 patients who had superficial venous arterialisation in the cohort study of 60 patients (Djoric 2012).

    Swelling of the foot was reported in 2 patients who had superficial venous arterialisation in the cohort study of 36 patients (Djoric 2011).

    Other complications

    Pneumonia was reported in 1 patient who had superficial venous arterialisation in the cohort study of 60 patients (Djoric 2012). Pneumoniawas described in 1 patient in the superficial venous arterialisation group in the cohort study of 36 patients (Djoric 2011).

    Cardiac decompensation was reported in 2 patients who had superficial venous arterialisation in the cohort study of 60 patients (Djoric 2012). Of the 2 patients, 1 patient had a fatal outcome.

    Anecdotal and theoretical adverse events

    In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly happen, even if they have never happened).

    For this procedure, professional experts listed the following anecdotal and theoretical adverse events: peripheral embolisation, potentially steal syndrome and other adverse events that are similar to a hybrid vascular procedure, involving interventional radiology and vascular surgery.