Early and eighteen month clinical outcomes of first UK case of percutaneous deep vein arterialisation (pDVA) to treat “no option” chronic limb-threatening ischemia using the LimFlow system

BACKGROUND: Chronic limb-threatening ischaemia (CLTI) in cases where there are no further standard treatment options for limb salvage represents the most advanced stage of peripheral arterial disease. For these “no-option” CLTI patients, an experimental treatment of foot vein arterialisation (FVA) was first described in 1912, however, it was never widely adopted as outcomes varied significantly most likely due to the complexity of the surgical intervention and lack of standardisation. In recent years there have been significant developments in performing FVA fully percutaneously and standardising the procedure with the introduction of specific indications for patient selection, a dedicated set of devices and structured follow up. This case represents the first UK use of the dedicated LimFlow System as a standardised procedure to perform percutaneous deep vein arterialisation (pDVA) in a “no option” CLTI patient according to the latest treatment recommendations in the literature, with outcomes out to 18 months post-procedure. CASE PRESENTATION: We present the case of a 78 year old male diabetic patient with a history of contralateral below knee amputation who presented with ischaemic rest pain and dry gangrene involving his left heel and first and second toes. Following review by the lower limb multi-disciplinary team at our institution, the patient was deemed to have no surgical or endovascular treatment options, apart from major amputation, as there was no suitable target for either angioplasty or bypass. He was therefore referred as a candidate for percutaneous deep vein arterialisation (pDVA) with the LimFlow System (LimFlow SA, France). After screening of the patient according to the indications for use, the pDVA procedure was successfully performed resulting in complete resolution of ischaemic rest pain immediately following the procedure, and adequate revascularisation of the foot. Following the index procedure, the subject went on to have minor amputation of the first, second and third toes 2 months post initial procedure with further secondary angioplasty procedures to optimise the flow throughout the arterialised circuit up to 4 months after the initial procedure. He underwent elective completion transmetatarsal amputation at 13 months post index procedure. The surgical wounds post minor amputation and the heel wound showed continued healing, especially after secondary optimisation of the pDVA outflow, with tissue epithelialisation by 6 months and complete healing by 18 months after the index procedure. CONCLUSIONS: This case report demonstrates the clinical outcomes of a technically-successful standardised pDVA procedure with the LimFlow system including both limb salvage and wound healing at 18 months. It also highlights the importance of close clinical and radiological surveillance post-index procedure and the requirement for re-interventions to optimise wound healing.