Interventional procedure overview of percutaneous deep venous arterialisation for chronic limb-threatening ischaemia
Closed for comments This consultation ended on at Request commenting lead permission
Other relevant studies
Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5.
Article | Number of patients and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Clair D and Gibbons M (2021) A review of percutaneous deep vein arterialization for the treatment of nonreconstructable chronic limb threatening ischemia. Seminars in vascular surgery 34(4): 188-94 | Review | Patients with no-option CLTI are at an extremely high risk for amputation along with its associated increases in morbidity and mortality. Both the ALPS multicentre study and the PROMISE I multicentre early feasibility study have shown encouraging results for these patients with high rates of limb salvage and wound healing, comparable with previous reports. Further research with larger patient populations is needed to assess the use of percutaneous DVA in patients with no-option CLTI, in order to improve our understanding and management of this disease. The PROMISE II trial is currently enrolling patients to provide information regarding the use of this technology in a larger group of patients and we look forward to the outcomes of this trial. | Review article |
Choinski KN, Stafford NJ, Rao AG et al. (2022) The feasibility and applicability of percutaneous deep vein arterialization in peripheral artery disease. Surgical technology international 40: 271-279 | Review | PDVA is a novel intervention to promise wound healing and amputation-free survival in patients with CLTI. This therapy should be reserved for patients with end-stage peripheral arterial disease with no alternative endovascular intervention or targets for open bypass. Outcomes from early feasibility trials and authors centre's personal experience with PDVA are encouraging in terms of technical success and limb salvage. However, current data is limited, and patients are still at high risk for complications given their progressive disease, needing close monitoring and coordinated wound care. Further investigation of the technique in multiple centres, with increased number of patients, and long-term follow up is warranted to better understand the feasibility and outcomes for patients undergoing PDVA. | Review article |
Gandini R, Merolla S, Scaggiante J et al. (2018) Endovascular distal plantar vein arterialisation in dialysis patients with no-option critical limb ischemia and posterior tibial artery occlusion: a technique for limb salvage in a challenging patient subset. Journal of Endovascular Therapy 25(1) 127–32 | Case series n=9 Follow up: mean 6 months | Although further investigations are required, distal plantar venous arterialization may represent a promising technique to improve recanalization rates and limb salvage in diabetic, end-stage renal disease patients with extremely calcified PTA occlusions. | Small sample and short follow up |
Ho VT, Gologorsky R, Kibrik P et al. (2020) Open, percutaneous, and hybrid deep venous arterialization technique for no-option foot salvage. Journal of vascular surgery 71(6): 2152-60 | Review | This review provides an up-to-date review of DVA indications, description of various DVA techniques, patient selection associated with each approach, and outcomes for each technique. | Review article |
Ichihashi S, Shimohara Y, Bolstad F et al. (2020) Simplified endovascular deep venous arterialization for non-option cli patients by percutaneous direct needle puncture of tibial artery and vein under ultrasound guidance (AV spear technique). Cardiovascular and interventional radiology 43(2): 339-43 | Case report n=1 | the AV spear technique can facilitate the pDVA for non-option CLI patients without the need for a dedicated ultrasonic catheter, re-entry device, or covered stents, making it widely applicable in many countries. However, this is a single case report and larger studies are necessary to evaluate the efficacy of the technique. | Single case report |
Karimi A, Lauria AL, Aryavand B et al. (2022) Novel therapies for critical limb-threatening ischemia. Current cardiology reports 24(5): 513-517 | Review | Recent advancements in the treatment options of CLTI will likely lead to reducing the rate of major amputations if they are adopted in a collaborative environment in order to apply the most appropriate treatment option to each individual patient based on the anatomy, comorbidities, functional status, and local expertise. | Review article |
Kutsenko O, Nasiri A, Maguire MJ et al. (2022) Technical approach to percutaneous femoropopliteal bypass and deep vein arterialization. Techniques in vascular and interventional radiology 25(3): 100843 | Review | In the management of patients with CLI, endovascular revascularisation plays a crucial role improving amputation free survival, ischemic rest pain, and wound healing. Although angioplasty and stenting are well established techniques and considered a standard of care, they may fail or achieve suboptimal results in a subset of CLI patients. Alternative techniques such as percutaneous femoropopliteal bypass and deep vein arterialization should be considered by endovascular specialists for long-segment arterial occlusions and patients without distal revascularisation target prior to amputation, respectively. | Review article |
Lechareas S, Sritharan K and McWilliams RG (2021) 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. CVIR Endovascular 4:62 | Case report n=1 | 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. | Single case report |
Migliara B, Mirandola M, Griso A et al. (2020) Totally percutaneous deep foot vein arterialization in a patient with no-option critical limb ischemia, scheduled for bilateral major amputation. Journal of vascular and interventional radiology: JVIR 31(9): 1505-7 | Case report n=1 | PDVA can be considered an alternative treatment in patients with "no-option" CLI, provided that it is performed in compliance with defined technical key points and associated with specific foot surgery. | Single case report |
Mustapha JA, Saab FA, Clair D et al. (2019) Interim results of the PROMISE I trial to investigate the LimFlow system of percutaneous deep vein arterialization for the treatment of critical limb ischemia. The Journal of invasive cardiology 31(3): 57-63 | PROMISE I (interim results) n=10 Follow up: 6 months | PDVA using the LimFlow system is a novel approach for treating patients with no-option CLI and may reduce amputation in this population for whom it would otherwise be considered inevitable. Initial findings from this early feasibility trial are promising and additional study is warranted. | PROMISE I is included in the key evidence. |
N'Dandu Z, Bonilla Jo, Yousef GM et al. (2021) Percutaneous deep vein arterialization: An emerging technique for no-option chronic limb-threatening ischemia patients. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions 97(4): 685-90 | Case report n=1 | This study presented a case of a patient with no-option CLTI, at high risk of amputation who failed conventional endovascular revascularisation attempts facing imminent major amputation. The limb was salvaged with a successful PDVA procedure. | Single case report |
Pua U and Huang IKH (2019) Percutaneous deep vein arterialization. Journal of vascular and interventional radiology: JVIR 30(4): 610-613 | Case report n=1 | DVA using off-the-shelf endovascular devices represents a potential last-ditch limb salvage technique in patients with CLI and no other treatment options. | Single case report |
Schreve MA, Unlu C, Kum S et al. (2017) Surgical and endovascular venous arterialization: ready to take the "desert" by storm? The Journal of cardiovascular surgery 58(3): 402–8 | Review | Venous arterialisation may be a viable alternative to preserving limbs. The percutaneous approach shows promise and is a minimally invasive technique to reduce surgical stress in patients with CLI. | Review article |
Yan Q, Prasla S, Carlisle DC et al. (2022) Deep venous arterialization for chronic limb threatening ischemia in atherosclerosis patients – a meta-analysis. Annals of vascular surgery, 1-21 | Meta-analysis n=442 (455 limbs; 12 studies) | Venous arterialisation has an acceptable a 1-year limb salvage rate of 79%, however, this is based on low levels of evidence. More randomized controlled trials or high-quality cohort studies are needed to further define the effectiveness of this procedure for CLTI. | 6 studies (2 in the key evidence and 4 in the appendix) described PDVA but outcomes for this procedure were not reported separately. |
Ysa, August, Lobato, Marta, Mikelarena, Ederi et al. (2019) Homemade device to facilitate percutaneous venous arterialization in patients with no-option critical limb ischemia. Journal of endovascular therapy: an official journal of the International Society of Endovascular Specialists 26(2): 213-8 | Case series n=5 follow up: 6 months | The described manoeuvers may be a useful option for creating a percutaneous AVF during a venous arterialization procedure in no-option CLI patients. Larger series with follow-up examinations are required to confirm the safety and effectiveness of this technique. | Small sample |
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions