Hybrid Foot Vein Arterialization in No-Option Patients With Critical Limb Ischemia: A Preliminary Report (original) (raw)
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Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2017
To report the initial clinical experience with percutaneous deep vein arterialization (PDVA) to treat critical limb ischemia (CLI) via the creation of an arteriovenous fistula. Seven patients (median age 85 years; 5 women) with CLI and no traditional endovascular or surgical revascularization options (no-option CLI) were recruited in a pilot study to determine the safety of PDVA. All patients were diabetic; 4 had Rutherford category 6 ischemia. Six were classified at high risk of amputation based on the Society for Vascular Surgery WIfI (wound, ischemia, and foot infection) classification. The primary safety endpoints were major adverse limb events and major adverse coronary events through 30 days and serious adverse events through 6 months. Secondary objectives included clinical efficacy based on outcome measures including thermal measurement, transcutaneous partial pressure of oxygen (TcPO2), clinical improvement at 6 months, and wound healing. The primary safety endpoints were ac...
Annals of Vascular Surgery, 2013
Objectives: Patients with critical limb ischemia (CLI) have a poor life expectancy, and aggressive revascularization is accepted as a means to maintain their independence in the end stage of life. The goal of this case-control study was to evaluate the clinical outcome of distal venous arterialization and compare this with pedal bypass surgery in patients with CLI, and to identify potential risk factors that could be used to effectively identify patients at high risk of graft occlusion and amputation. Methods: A retrospective cohort of patients was treated for CLI using venous arterialization or pedal bypass between 2007 and 2012. Kaplan-Meier and Cox regression analyses were used to evaluate predictors for limb salvage and patency. Results: In 40 patients with CLI, 21 venous arterializations and 19 pedal bypasses were performed. In the venous arterialization group, early occlusion was 15%, 1-year patency was 71%, and limb salvage was 53%. In the PB group, early occlusion was 23%, one-year patency was 75% and limb salvage was 47%. The only independent risk factor for limb salvage in multivariate analysis was bypass occlusion (P < 0.001). Conclusions: Limb salvage after venous arterialization was equal to limb salvage after pedal bypass surgery in this clinical comparative study.
Global vascular guidelines on the management of chronic limb-threatening ischemia
Journal of Vascular Surgery
Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.
Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.
Surgical Practice, 2014
The aim of the present study was to evaluate current results of endovascular and open-bypass treatment of critical limb ischaemia subsequent to advancement in endovascular instruments and the development of endovascular technique in the past decade. Patients and Methods: A total of 160 patients with 167 limbs treated at a single centre between 2008 and 2012 were followed up for at least 2 years and reviewed retrospectively. Patients were stratified into an endovascular group and an open-bypass group based on first intervention received. The two groups demonstrated comparable demographics, clinical profile classified by Rutherford Classifications and lesion characteristics evaluated according to TransAtlantic Intersociety Consensus staging standards. One-year primary patency, 2-year primary patency, secondary patency, overall survival rate and amputation-free-survival rate were compared between the endovascular group and open-bypass group. Results: The endovascular group showed superior results to the bypass group in terms of 1-year amputation-free-survival (endovascular: 78.2 per cent, open bypass: 61.3 per cent, P = 0.023) and 2-yearamputation-free-survival (endovascular: 73.1 per cent, open bypass: 56 per cent, P = 0.027). No significant difference was found between the two groups in 1-year primary patency (endovascular: 80.3 per cent, open bypass: 67.8 per cent, P = 0.103), 2-year primary patency (endovascular: 80.3 per cent, open bypass: 64.8 per cent, P = 0.056), 1-year secondary patency (endovascular: 77.8 per cent, open bypass: 66.7 per cent, P = 0.577) and two-year secondary patency (endovascular: 77.8 per cent, open bypass: 58.3 per cent, P = 0.350). Comparable results were noted in the 1-year survival rate (endovascular: 91 per cent, open bypass: 81.3 per cent, P = 0.082) and 2-year survival rate (endovascular: 84.6 per cent, open bypass: 72 per cent, P = 0.058). Lower median blood loss (endovascular: 15 mL, open bypass: 100 mL) and shorter mean operative time (endovascular: 27.2 min, open bypass: 143.1 min) were demonstrated in the endovascular group. Conclusion: Endovascular intervention has demonstrated superior results to bypass surgery in critical limb ischaemia in terms of 1-year and 2-year amputation-free-survival, with potential benefits of lower intraoperative blood loss and a shorter operative time. Primary patency, secondary patency and overall survival in 2 years are currently comparable between the two intervention modalities.
Endovascular management of patients with critical limb ischemia
Journal of Vascular Surgery, 2011
Background: Although percutaneous intervention (PTA) is considered first-line therapy for peripheral vascular disease in many scenarios, its role in critical limb ischemia (CLI), wherein anatomic disease is more extensive, remains unclear. In the present study, late (5-year) clinical and patency data for PTA in CLI are defined. Methods: From January 2002 to December 2007, 409 patients underwent infrainguinal PTA ؎ stent for CLI (Rutherford IV-VI) of 447 limbs. Primary patency, assisted patency, limb salvage, and survival were assessed using Kaplan-Meier. Predictors of patency, limb salvage, and death were determined using multivariate models. Results: Demographics included age (70 ؎ 12 years old), diabetes (65.8%), and dialysis dependence (13%). The superficial femoral artery was treated in 58% of the patients, 16% were limited to the crural vessels, 38% had multilevel treatment, and stents were placed in 26%. Eighty percent of patients received postprocedure clopidogrel. Mean follow-up was 28 months (0-83). Five-year primary and assisted patency were 31% ؎ 0.04 and 75% ؎ 0.04, respectively. Limb salvage at 5 years was 74% ؎ 0.038. Sixty-three patients had major amputations. Survival at 5 years was 39% ؎ 0.03. Multivariate analysis identified dialysis dependence (P ؍ .0005; 2.7 [1.6-4.8]), <1 vessel runoff (P ؍ .02; 1.5 [1.1-2.0]), and warfarin use (P ؍ .001; 1.7 [1.25-2.3]) as negative predictors of primary patency, but none of these were negative predictors of assisted patency. Dialysis dependence (P ؍ .006; 2.5 [1.3-4.8]), female gender (P ؍ .02; 2.0 [1.1-3.7]), and <1 vessel runoff (P ؍ .04; 1.8 [1.0-3.2]) predicted limb loss. Dialysis dependence (P ؍ .0003; 2.3 [1.5-3.5]), diabetes (P ؍ .04; 1.5 [0.5-2.1]), and poor runoff (P ؍ .04; 1.6 [1.2-2.1]) were predictors of mortality. Conclusion: Although primary patency is low, excellent limb salvage rates can be achieved in patients with CLI through close follow-up and secondary interventions. These data, and the 12% annual death rate, validate PTA as first-line therapy in patients with CLI.
Diabetic Foot & Ankle, 2013
Background: Patients with critical lower limb ischemia without patent pedal arteries cannot be treated by the conventional arterial reconstruction. Venous arterialization has been suggested to improve limb salvage in this subgroup of patients but has not gained wide acceptance. We report our early experience after implementing deep and superficial venous arterialization of the lower limb. Materials and methods: Ten patients with critical ischemia and without crural or pedal arteries available for conventional bypass surgery or angioplasty were treated with distal venous arterialization. Inflow was from the most distal unobstructed segment. Runoff was the dorsal pedal venous arch (n 05), the dorsal pedal venous arch and a concomitant vein of the posterior tibial artery (n 03), or the dorsal pedal venous arch and a concomitant vein of the common plantar artery (n 02) depending on the location of the ischemic lesion. Venous valves were destroyed using antegrade valvulotomes, guide wires, knob needles, or retrograde valvulotomes via an extra incision. Results: Seven of the operated limbs were amputated after 23 (1Á256) days (median [range]). The main reasons for amputation were lack of healing of either the original wound, of incisional wounds on the foot, or persisting pain at rest. In three cases, the bypass was open at the time of amputation. Two patients experienced complete wound healing after 231 and 342 days, respectively. By the end of follow-up, the last patient was ambulating with slow wound healing but without pain 309 days after surgery. Conclusion: Venous arterialization may be used as a treatment of otherwise unsalveable limbs. The success rate is, however, limited. Technical optimization of the technique is warranted.
Endovascular management of patients with critical limb ischemia: Long-term results
Journal of Vascular …, 2011
Background: Although percutaneous intervention (PTA) is considered first-line therapy for peripheral vascular disease in many scenarios, its role in critical limb ischemia (CLI), wherein anatomic disease is more extensive, remains unclear. In the present study, late (5-year) clinical and patency data for PTA in CLI are defined. Methods: From January 2002 to December 2007, 409 patients underwent infrainguinal PTA ؎ stent for CLI (Rutherford IV-VI) of 447 limbs. Primary patency, assisted patency, limb salvage, and survival were assessed using Kaplan-Meier. Predictors of patency, limb salvage, and death were determined using multivariate models. Results: Demographics included age (70 ؎ 12 years old), diabetes (65.8%), and dialysis dependence (13%). The superficial femoral artery was treated in 58% of the patients, 16% were limited to the crural vessels, 38% had multilevel treatment, and stents were placed in 26%. Eighty percent of patients received postprocedure clopidogrel. Mean follow-up was 28 months (0-83). Five-year primary and assisted patency were 31% ؎ 0.04 and 75% ؎ 0.04, respectively. Limb salvage at 5 years was 74% ؎ 0.038. Sixty-three patients had major amputations. Survival at 5 years was 39% ؎ 0.03. Multivariate analysis identified dialysis dependence (P ؍ .0005; 2.7 [1.6-4.8]), <1 vessel runoff (P ؍ .02; 1.5 [1.1-2.0]), and warfarin use (P ؍ .001; 1.7 [1.25-2.3]) as negative predictors of primary patency, but none of these were negative predictors of assisted patency. Dialysis dependence (P ؍ .006; 2.5 [1.3-4.8]), female gender (P ؍ .02; 2.0 [1.1-3.7]), and <1 vessel runoff (P ؍ .04; 1.8 [1.0-3.2]) predicted limb loss. Dialysis dependence (P ؍ .0003; 2.3 [1.5-3.5]), diabetes (P ؍ .04; 1.5 [0.5-2.1]), and poor runoff (P ؍ .04; 1.6 [1.2-2.1]) were predictors of mortality. Conclusion: Although primary patency is low, excellent limb salvage rates can be achieved in patients with CLI through close follow-up and secondary interventions. These data, and the 12% annual death rate, validate PTA as first-line therapy in patients with CLI.