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    Interventional procedure overview of percutaneous deep venous arterialisation for chronic limb-threatening ischaemia

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    Outcome measures

    Outcomes measures included technical or procedural success, clinical improvement (including wound healing), tissue oxygenation (TcPO2), survival, amputation-free survival, limb salvage/amputation, patency and associated reintervention. Mortality and adverse events were also reported. The main measures used are detailed in the following paragraphs.

    Technical success was defined as successful creation of AVF with PDVA and direct blood flow to the deep venous arch.

    Procedural success was defined as the combination of technical success and absence of all-cause death, above-ankle amputation, or clinically driven major reintervention of the stent graft at 30 days.

    Clinical improvement was defined as resolution of rest pain, tissue formation of granulation tissue/complete wound healing, or both. It also referred to a decrease in at least 1 point from baseline of the Rutherford category:

    • 0: asymptomatic

    • 1: mild claudication

    • 2: moderate claudication

    • 3: severe claudication

    • 4: ischaemic rest pain

    • 5: minor tissue loss

    • 6: ulceration or gangrene

    Wound healing: fully healed was defined as all surfaces of the wound fully epithelialised, and healing was defined as evidence of granulation tissue formation, apparent wound edge epithelialisation, and evident contraction of wound edges.

    WIfI classification system was used, based on the 3 main factors (wound, ischaemia and foot infection) that have an impact on limb amputation risk. The ischaemia category focused on measuring the hemodynamic or perfusion of the patient using several different diagnostic measurements. Grades for each factor are shown below:

    Wound:

    • 0: no ulcer and no gangrene

    • Small ulcer and no gangrene

    • Deep ulcer and gangrene limited to toes

    • Extensive ulcer or extensive gangrene

    Ischaemia: toe pressure/TcPO2:

    • 0: more than 60 mmHg

    • 1: 40 to 59 mmHg

    • 2: 30 to 39 mmHg

    • 3: less than 30 mmHg

    A TcPO2 value of 40 mmHg is the critical value below which wound healing is impaired and ischaemia develops. TcPO2 values of 40 mmHg or above are predictive of wound healing.

    Infection:

    • 0: noninfected

    • 1: mild (less than 2 cm cellulitis)

    • 2: moderate (more than 2 cm cellulitis/purulence)

    • 3: severe (systematic response/sepsis)

    AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality.

    Limb salvage was referred to freedom from major amputation.

    MACE included cardiac-related death, cardiac events and stroke.

    MALE was defined as major amputation (transtibial or above) or major vascular reintervention (bypass graft, thrombectomy, or thrombolysis) in the index limb but not including percutaneous reinterventions.

    SAE were defined as events that resulted in death, a life-threatening condition, cause either an inpatient hospitalisation or a prolonged existing hospitalisation, result in persistent or significant disability or incapacity, or require intervention to prevent permanent impairment or damage.