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Objective: Local intramuscular transplantation of granulocyte colony-stimulating factor (G-CSF)-mobilised peripheral blood mononuclear cells (PB-MNC) has been shown to be effective for treating patients with no-option critical limb ischaemia (CLI) who are not considered suitable to undergo surgical bypass or percutaneous transluminal angioplasty. The aim of this study was to investigate the effectiveness and safety of PB-MNCs as a treatment for no-option CLI patients. Method: This prospective cohort study was conducted between April 2013 and December 2017. Patients with no-option CLI were treated with G-CSF 5–10 µg/kg/day for 3 days. PB-MNCs (7.1±2.2×10 10 ) with CD34+ cells (2.1±1.2×10 8 ) were collected by blood cell separator and then injected into the calf or thigh of ischaemic limbs. Ankle–brachial index, toe–brachial index and transcutaneous oxygen tension were recorded at 1 and 3 months after injection. The amputation rate and the wound healing rate were also recorded. Results: Eight patients took part in the study. Two patients experienced rest pain relief 1 month after PB-MNC therapy. Five patients had healed ulcer at 6 months after PB-MNC therapy. Limb ischaemia did not improve after PB-MNC therapy in one patient. Below-knee amputation was performed in that patient due to extension of gangrene. Two patients required reinjection of PB-MNCs because of recurrence of ischaemic ulcer. The limb salvage rate after 1 year was 87.5%. Conclusion: Local intramuscular transplantation of G-CSF-mobilised PB-MNCs might be a safe and effective treatment for no-option CLI patients.

Summary: Background: Peripheral artery disease presents an increasing healthcare burden worldwide. Day-case angioplasty in a secondary care setting can be a safe and effective means of meeting the growing demand for lower limb revascularisation. We evaluated the safety and efficacy of a day-case-based angioplasty service in a UK district general hospital. Patients and methods: Consecutive patients undergoing endovascular revascularisation between August 2018–February 2020 were analysed retrospectively. All patients were discussed at a multi-disciplinary (diabetic foot) team meeting following a day case algorithm. Patient and procedural characteristics, technical success, peri-procedural complications, and 30-day outcome of day-case angioplasties were compared with those requiring overnight stay or were hospitalized. Results: Fifty-seven percent of 138 patients were diabetic, mean age 75 ± 12 years, 95% had critical limb ischaemia (Fontaine III 12%, IV 83%), and baseline ankle brachial pressure index [ABPI] 0.40 ± 0.30. Sixty-three patients (45%) were treated as planned day cases, 21 (15%) required overnight admission for social indications. Fifteen (11%) were planned admissions with the need for sequential debridement procedures, and 39 (28%) were already hospitalised at the time of referral to the vascular service. The overall technical success was 92% and not successful procedures mainly occurred in patients > 80 years. The ABPI increased at the initial follow-up to 0.84 ± 0.18. Fifty-three percent required treatment of > 1 level, 80% included recanalisations of chronic total occlusions, and average total lesion length was 133 ± 90 mm. Closure devices were employed in all cases. There were no major peri-procedural complications. A single minor access-site related bleeding episode (0.8%) occurred, requiring 24 h observation in hospital. While significantly more wounds had closed in out-patients, the mortality, major amputation and target lesion revascularization did not differ between groups. Conclusions: Safe and effective day-case-based angioplasty can be provided in a secondary care setting for patients with critical limb ischaemia needing complex multi-level procedures.

Objectives Peripheral artery disease is estimated to affect 237 million individuals worldwide. Critical limb ischaemia, also known as chronic limb threatening ischaemia is a consequence of the progression of peripheral artery disease which occurs in ∼21% of patients over a five-year period. The aim of this systematic review is to assess the use of additional below-the-ankle angioplasty in comparison to the use of above-the-ankle angioplasty alone, and the subsequent rates of amputation, wound healing, restenosis, rest pain, reintervention and complications. Methods This systematic review was undertaken in accordance with PRISMA guidelines following a registered protocol (CRD42019154893). Online databases were searched using a search strategy of 20 keywords. Included articles reported the outcome for inframalleolar (pedal artery, pedal arch, plantar arteries) angioplasty with additional proximal angioplasty in comparison to proximal angioplasty alone. GRADE assessment was applied to assess the quality of the evidence. Results After screening 1089 articles, 10 articles met the inclusion criteria. Comparative performance assessment of below-the-ankle with above-the-ankle versus above-the-ankle angioplasty alone was undertaken in 3 articles, with the remaining 7 articles reporting outcomes of below-the-ankle with above-the-ankle angioplasty with no distinct comparator group. Significant decrease in major lower limb amputation at the last follow-up in the below-the-ankle group when compared with the above-the-ankle angioplasty alone group was observed in a single study (3.45% vs. 14.9%, p Conclusion To date, there is a lack of studies assessing inframalleolar interventions and their use in improving limb salvage, wound healing and symptomatology. Prospective RCTs should be undertaken with adequate participant numbers to be sufficiently powered and report clinically important end-points.

Objective: In critical limb ischaemia (CLI), first-line therapy is revascularisation, but alternative treatment options are needed in certain cases. Maggot debridement therapy (MDT) is historically considered to be contraindicated in ischaemic ulcers. Wound care in patients with CLI is becoming increasingly diverse with the development of novel revascularisation strategies; therefore, CLI now needs to be reconsidered as an indication for MDT. Method: We retrospectively reviewed five legs with CLI (five male, one female) treated with MDT between January 2013 and December 2017. Changes in skin perfusion pressure (SPP) around the ulcer before and after MDT were evaluated. One or two cycles of MDT were performed (eight in total). We also evaluated the proportion of necrotic tissue in the ulcer and the presence of exposed necrotic bone. The proportion of necrotic tissue in the ulcer was classified as NT 1+ (75%). Results: When the proportion of necrotic tissue was >50%, with no exposed necrotic bone in the wound, an increase in SPP was observed after five (62.5%) of eight cycles of MDT. And with a proportion of necrotic tissue of Conclusion: Effective MDT with increased SPP requires an ulcerative state of necrotic tissue grade > NT 3+, with no exposed necrotic bone.

When diabetes mellitus is not properly controlled with drugs and a healthy lifestyle, it exposes patients with advanced peripheral arterial disease or critical limb ischaemia (CLI) to the most serious complications, in particular lower limb ulcers. Surgical or endovascular treatments represent the first line of intervention; in addition, the adequate management of ulcers can guarantee not only a faster wound healing but also the improvement of the patient's prognosis. To speed up this process, negative pressure wound therapy (NPWT), platelet‐rich plasma (PRP), and other advanced moist wound dressing have been proposed. During Coronavirus disease 2019 (COVID‐19) pandemic, many patients with CLI and diabetes mellitus had difficult access to advanced treatments with a significant reduction in life expectancy. We report the cases of patients with non‐healing ulcers and CLI treated with an empiric multistage approach after successful endovascular revascularisation; the postoperative course was eventful in all patients, and foot ulcers are currently in an advanced state of healing. The association between adequate revascularisation, systemic anti‐inflammatory, and antibiotic therapy with the multistage advanced medications ensures healing of ulcers, limb salvage, and improvement of patient prognosis.

Objectives Revascularization according to the angiosome concept is of proven importance for limb salvage in chronic limb threatening ischaemia but it is not always practicable. Bifurcated bypasses could be considered as an option when an endovascular approach is not feasible or has already failed and a single bypass would not allow direct revascularization of the ischaemic area. Bifurcated bypasses are characterized by landing on two different arteries, the main artery (in direct continuity with the foot vessels) and the secondary one (perfusing the angiosome district). The aim of this study is to evaluate the safety and effectiveness of bifurcated bypass in chronic limb threatening ischaemia. Methods Thirty-five patients were consecutively treated with a bifurcated bypass for chronic limb threatening ischaemia from January 2014 to December 2019 in a single vascular surgery centre. Data from clinical records and operative registers were collected prospectively in an electronic database and retrospectively analysed. Primary and primary assisted bypass patency, amputation-free survival, morbidity and mortality rates at 12 and 24 months were analysed. Results Mean follow-up period was 25.1 months (range 2–72 months). Thirty-six bifurcated bypasses were performed on 35 patients (age 75.3 ± 7.2 years; 69.4% were male). According to Wound, Ischemia, foot Infection classification 22.2% belonged to stage 3 and 77.8% to stage 4 and the mean Rutherford’s class was 5.1 ± 0.7. Immediate technical success was 100%. Early mortality and morbidity rates were respectively 5.5%, and 33.3%; foot surgery was performed in 50% of cases with wound healing in all patients. Primary patency and primary assisted bypass patency were 96.7% and 100% at 6 months; 85.2% and 92% at 12 months, 59.9% and 73.4% at 24 months, respectively. Amputation-free survival at 12 and 24 months was, respectively, 95.6% and 78.8%. Overall survival rates at 12 and 24 months were respectively 94.4% and 91.6%. Conclusions Bifurcates bypass can provide good results in patients with chronic limb threatening ischaemia without endovascular option, especially in diabetic ones. Bifurcated bypass is a complex surgical solution, both to be planned and performed, and it is quite invasive for frail patients that should be accurately selected.

Objectives While current guidelines describe the importance of assessing limb characteristics for predicting limb prognosis in patients with critical limb ischaemia (CLI), several reports have also suggested that systemic factors are associated with limb prognosis. The aim of this study was to evaluate whether systemic factors have the same impact on wound healing as limb characteristics in CLI patients undergoing endovascular therapy. Methods A total of 735 patients who were treated for the first time for CLI with tissue loss between April 2010 and December 2015 were extracted from a prospective registry and data for the Wound, Ischaemia, and foot Infection (WIfI) classification were searched retrospectively. The predictors of wound healing were explored with Cox proportional hazards regression. Results The one year wound healing rate was 60.2% in WIfI stage 1–3 patients and 53.6% in WIfI sstage 4 (p = .01). In WIfI stage 1–3, no systemic factors were significantly associated with wound healing, whereas, in WIfI stage 4 patients. Non-ambulatory status [hazard ratio (HR) 1.98; 95% confidence interval (CI) 1.37–2.84], haemodialysis (HR 1.90; 95% CI 1.33–2.72) and an albumin level under 3.0 g/dL (HR 1.53; 95% CI 1.02–2.31), were identified as independent risk factors for failure to achieve wound healing. If none or one of these risk factors were present, wound healing was comparable with WIfI 4 and WIfI 1–3 patients (67.7% vs. 63.6%, p = .89), whereas in patients with two or more risk factors wound healing was worse in WIfI 4 than in WIfI 1–3 patients (35.7% vs. 49.5%, p = .01). Conclusion Non-ambulatory status, haemodialysis, and a low albumin level were additional systemic risk factors for impaired wound healing in patients with WIfI stage 4. The wound healing rate in WIfI stage 4 patients with one or fewer of these risk factors was comparable to that in WIfI stage 1–3.

Objectives Early bedside post-operative monitoring of infrainguinal bypass surgery is currently based on subjective clinical findings and handheld Doppler signals. Infrared thermal imaging is an objective and reproducible technique that has been proven to be a reliable and accurate method to measure skin temperature. The aim of this prospective study was to assess infrared thermal imaging as a predicting tool of bypass graft outcome in the immediate post-operative period and assess the angiosome concept. Methods This was a prospective cohort study of 25 patients undergoing infrainguinal bypass. Demographic and clinical data were prospectively collected and included gender, age, co-morbidities, pre- and post-operative ankle brachial pressure indices, surgery undertaken and patency of run-off vessels. Infrared thermal imaging was undertaken pre- and post-operatively to assess thermal changes to the feet following revascularisation. Results We found that an increase in temperature from pre- to post-operative was significantly associated with bypass patency. An increase in temperature was found to have a positive predictive value of 75%, a negative predictive value of 100%, a sensitivity of 100% and specificity of 89% for predicting graft patency. Conclusions Infrared thermal imaging can be used to measure temperature related changes of the microcirculation post-operatively and predict bypass outcomes in the immediate post-operative period.

Objective: Most major lower limb amputations are related to peripheral artery disease (PAD) or diabetes. Just 40% of patients who undergo major lower limb amputation will use a prosthesis, yet measures of surgical success commonly focus on prosthesis use. Patient-reported outcome measures (PROMs) are valuable to comprehensively evaluate health-related quality of life (HRQL) after surgery. This systematic review aimed to identify and describe PROMs available to assess HRQL in patients after amputation for PAD or diabetes.Methods: A search was conducted based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) for systematic reviews of PROMs. Ovid MEDLINE, Ovid EMBASE, PsycINFO, CINAHL, and Cochrane CENTRAL were also searched from inception until August 2019. Included were articles describing the development, measurement properties, or evaluation of HRQL via a PROM in adult patients after amputation for PAD or diabetes. Studies of amputation exclusively for trauma or malignancy were excluded. Data were collected on study characteristics, PROM characteristics (generic/disease specific), and properties of amputation-specific PROMs.Results: Of 3 317 abstracts screened, 111 full-text articles were assessed for eligibility and 64 included. Fifty-six studies evaluated HRQL, with 23 (46%) of these using an amputation-specific PROM to do so. Eleven different amputation-specific PROMs were identified, 10 (91%) of which were developed only for prosthesis users. One measure was suitable for use in all patients after amputation. This “Amputee single item mobility measure” includes a single item evaluating mobility. Nine studies reported some psychometric testing of an amputation-specific PROM.Conclusion: A well-tested, multidimensional PROM applicable to wheelchair and prosthetic users after amputation is lacking and urgently needed for studies in this field. Future work to develop an appropriate measure is required.

Objectives The aim of this study is to investigate the durability and clinical efficacy of profundoplasty as a sole procedure in patients presenting with critical limb ischaemia associated with profunda femoral artery disease and superficial femoral artery occlusion. Methods Retrospective analysis of outcomes from all patients who underwent surgical profundoplasty in a single tertiary referral centre was performed. Patients who presented with either rest pain or tissue loss and had combined profunda femoral artery disease and superficial femoral artery occlusion were included in the study. Outcomes were compared between the rest pain and the tissue loss groups. Results Between 2009 and 2019, 51 procedures were performed in 49 patients; 27 (53%) procedures were performed for rest pain and 24 (47%) for tissue loss. Technical success was 100% in both groups. Procedure success was significantly better in the rest pain group owing to lower procedure-related complications ( p = 0.037). Incidence of major adverse cardiovascular events was higher in the tissue loss group with five reported cases compared to only one in the rest pain group ( p = .05); 85.2% of patients with rest pain experienced clinical improvement compared to only 33.3% in the tissue loss group ( p Conclusions Profundoplasty performed as a sole procedure for revascularisation of the critically ischaemic limb is a viable straightforward option. However, our results suggest that it may be more effective in the treatment of rest pain rather than in the setting of tissue loss when a combined superficial femoral artery angioplasty or distal bypass may be required.

The study was aimed at comparing the efficacy of implantation of autologous bone marrow cells with that of revascularizing osteotrephination in treatment of lower limb chronic critical ischaemia in patients with a poor distal vascular bed.We analysed the results of comprehensive examination and treatment of a total of 60 patients presenting with lower limb chronic critical ischaemia due to atherosclerotic lesions of the femoropopliteal-tibial segment. According to the technology of treatment, the patients were divided into two statistically homogenous groups of 30 people each. Group One patients underwent standard revascularizing osteotrephination and Group Two patients in accordance with the original technique received intramuscular implantation of 40 ml of autologous bone marrow cells, with this volume distributed in 2-ml injections to 20 points of the muscles of the crus and femur along the internal and external surface.The use of the original technique of treatment made it possible to achieve the clinical status in the form of moderate or minimal improvement 6 months after bone marrow cells implantation in 29 (96.7%) patients and after 12 months in 28 (93.3%) patients, whereas after revascularizing osteotrephination in 25 (83.3%) and 20 (66.7%) patients, respectively. In the remote period after 12 months, the limb was saved in 28 (93.3%) and 26 (86.7%) patients in Group Two and Group One, respectively. The patients of the second group as compared with those of the first group after 12 months demonstrated a statistically significant increase in the physical health component by 19.8% and the mental health component by 9.8%.Implantation of autologous bone-marrow cells in chronic critical limb ischaemia is pathogenetically substantiated and makes it possible to optimize the results of treatment of patients.ЦЕЛЬ: Сравнить эффективность имплантации аутоклеток костного мозга с эффективностью реваскуляризирующей остеотрепанации в лечении хронической критической ишемии нижних конечностей у больных с плохим дистальным руслом. МАТЕРИАЛ И МЕТОДЫ: Проведен анализ комплексного обследования и лечения 60 пациентов с хронической критической ишемией нижних конечностей на почве атеросклеротического поражения бедренно-подколенно-берцового сегмента. Больные по технологии лечения были разделены на 2 статистически однородные группы по 30 человек в каждой. Пациентам первой группы проводилась стандартная реваскуляризирующая остеотрепанация, а больным во второй группе по оригинальной технологии в ишемизированную конечность интрамускулярно имплантировали 40 мл аутоклеток костного мозга по 2 мл в 20 точек в мышцы голени и бедра по внутренней и наружной поверхности. РЕЗУЛЬТАТЫ: Применение оригинальной технологии лечения позволило достичь клинического статуса в виде умеренного или минимального улучшения через 6 месяцев после имплантации клеток костного мозга у 29 (96,7%), а через 12 месяцев – у 28 (93,3%) пациентов, тогда как после выполнения реваскуляризирующей остеотрепанации у 25 (83,3%) и у 20 (66,7%) больных соответственно. В отдаленном периоде через 12 месяцев конечность удалось сохранить во второй группе у 28 (93,3%), а в первой группе у 26 (86,7%) пациентов. У больных второй группы по сравнению с первой через 12 месяцев выявлено статистически достоверное увеличение физического компонента здоровья на 19,8%, психического компонента здоровья – на 9,8%. ЗАКЛЮЧЕНИЕ: Имплантация клеток костного мозга при хронической критической ишемии конечностей патогенетически обоснована и позволяет оптимизировать результаты лечения больных.

ObjectivesA patient-oriented appraisal of treatment has become extremely important, particularly in elderly patients with critical limb ischaemia (CLI). Quality of life (QoL) is an important patient-reported outcome in vascular surgery. Frequently, the physical domain of QoL questionnaires represents an ‘objective’ evaluation of performing activities, which is expected to be impaired after major limb amputation. However, an objective appraisal of physical function is an assessment of health status (HS) and not of QoL. Little is known about the subjective appraisal of physical health (QoL). The goal of this study was to evaluate, prospectively, QoL in relation to HS in elderly CLI patients undergoing major limb amputation.MethodsPatients suffering from CLI aged 70 years or older were included in a prospective observational cohort study with a follow-up period of 1 year. Patients were divided according to having had an amputation or not. The World Health Organization Quality Of Life-BREF (WHOQOL-BREF) was used to asses QoL. The 12-Item Short Form Health Survey (SF-12) was used to measure HS. These self-reported questionnaires were completed five times during follow-up.ResultsTwo-hundred patients were included of whom 46 underwent a major limb amputation within one year. Amputees had a statistically significant improvement of their physical QoL after six months (14.0 vs. 9.0 (95% CI -7.84;-1.45),p = 0.005) and after a one-year follow-up (14.0 vs. 9.0 (95% CI -9.58;-1.46),p = 0.008). They did not however show any statistically significant difference in HS. For non-amputees, both physical QoL and HS improved. An instant statistically significant improvement of the physical QoL appeared 1 week after inclusion (12.0 vs. 10.9 (95% CI -1.57;-0.63),pConclusionsThere is a clear difference between patients' functioning (HS) and the patients' appraisal of functioning (QoL). In elderly CLI patients, this study clearly suggests a discrepancy between the physical QoL (WHOQOL-BREF) and HS (SF-12) measurements in vascular amputees. This raises the question, which outcome measurement is the most relevant for elderly CLI patients. Individual treatment goals should be kept in mind when assessing the HS or QoL outcome of patients undergoing hospital care. With respect to shared decision making, distinctive and subjective QoL questionnaires, like the WHOQOL-BREF, provide a very important outcome measurement and should be used in future research.

Peripheral arterial disease (PAD) and its most severe form, critical limb ischaemia (CLI), are very common clinical conditions related to atherosclerosis and represent the major causes of morbidity, mortality, disability, and reduced quality of life (QoL), especially for the onset of ischaemic chronic leg ulcers (ICLUs) and the subsequent need of amputation in affected patients. Early identification of patients at risk of developing ICLUs may represent the best form of prevention and appropriate management. In this study, we used a Prediction System for Chronic Leg Ulcers (PredyCLU) based on fuzzy logic applied to patients with PAD. The patient population consisted of 80 patients with PAD, of which 40 patients (30 males [75%] and 10 females [25%]; mean age 66.18 years; median age 67.50 years) had ICLUs and represented the case group. Forty patients (100%) (27 males [67.50%] and 13 females [32.50%]; mean age 66.43 years; median age 66.50 years) did not have ICLUs and represented the control group. In patients of the case group, the higher was the risk calculated with the PredyCLU the more severe were the clinical manifestations recorded. In this study, the PredyCLU algorithm was retrospectively applied on a multicentre population of 80 patients with PAD. The PredyCLU algorithm provided a reliable risk score for the risk of ICLUs in patients with PAD.

Objective/Background To evaluate complete wound healing and limb salvage rates in patients with critical limb ischaemia (CLI) with concurrent foot ulceration/gangrene who underwent angiosome targeted infrapopliteal balloon angioplasty. Methods This was a prospective observational study. In total, 212 patients who underwent successful infrapopliteal balloon angioplasty to assist wound healing and achieve limb salvage were included from June 2014 to March 2016. Propensity score matching was developed to compare complete wound healing, 1 year amputation free survival (AFS), and limb salvage rates between the two study groups (direct revascularisation [DR] and indirect revascularisation [IR]). Results Direct flow to the foot wounds based on the angiosome principle was achieved in 117 legs (55.2%) versus 95 legs (44.8%) that represented the IR group. Seventy-three matched pairs were obtained to minimise intergroup differences in baseline characteristics. Twelve months after angioplasty, the complete wound healing rates were 80.8% and 63.0% (p = .02), AFS rates were 72.6% and 61.6% (p = .164), and limb salvage rates were 90.4% and 82.2% (p = .148) in the DR and IR groups, respectively. Conclusion This study suggests that the complete wound healing rate is better when the target foot lesion receives direct perfusion following the angiosome concept, whereas limb salvage and AFS rates were not significantly different among the DR and IR groups.

Critical limb ischaemia is the end stage of peripheral arterial disease before limb loss. Contemporary interventions to restore blood flow have high morbidity and mortality and fail to provide sustained restoration of peripheral circulation. Cell-based therapies designed to promote neovascularisation or angiogenesis have been shown in trials to be safe but clinically ineffective. Notwithstanding endless research in the area, no headway has been made in identifying a successful therapy designed specifically to target muscle disease in critical lower limb ischaemia. Thus, the quest to find an effective, lasting solution for critical lower limb ischaemia continues and requires more innovative therapeutic tactics. Our aim is to highlight the crucially interlinked role of the capillary bed, skeletal muscle mass and mitochondria in critical lower limb ischaemia patients and to identify novel therapeutic mechanisms that the vascular interventionalist can add to their armamentarium.

Hypercoagulable and proinflammatory states induced by the novel coronavirus (SARS-CoV-2) lead to thrombotic and embolic events. In this case report, the authors describe how they successfully managed acute critical limb ischaemia in a patient of COVID-19 illness with severe pulmonary disease and high thrombus burden in the infrapopliteal arteries.

Abstract. Patients with critical limb ischaemia have a poor life expectancy. Aggressive revascularization is accepted in order to preserve their independence in the final phase of their lives. Bypass surgery and more recently endovascular interventions with angioplasty and stenting have become the treatment of choice to prevent amputation and to resolve pain. However, as many as 20 % of patients with critical limb ischaemia are unsuitable candidates for a vascular intervention because of extensive occlusions of outflow in the crural and pedal vessels. Such “no-option critical limb ischaemia” may be treated with venous arterialization. In the present review, we discuss the history of the venous arterialization procedure, the mechanisms, the different techniques, and complications of venous arterialization.

Objective/Background Endovascular first is the preferred therapy approach to critical limb ischaemia (CLI). However, in spite of new endovascular techniques, bypass surgery still plays an important role, especially in patients with complex anatomy in whom endovascular therapy is not considered feasible, or has failed. The goal of this study was to analyse the outcomes of prosthetic or autologous vein for femoropopliteal (P3) bypasses performed under the abovementioned conditions. Methods A retrospective analysis of patients who underwent a femoropopliteal (P3) bypass for CLI (March 2007–December 2015) was conducted. Endovascular therapy was not possible. Patency rates, limb salvage, major adverse limb event (MALE) free survival, and survival after 5 years were analysed. Results In total, 151 cases were included in the analysis (rest pain 35.8%, ulcer/gangrene 64.3%). The graft material was autologous vein in 76 cases (vein group) and heparin bonded expanded polytetrafluoroethylene (HePTFE) in 75 cases (HePTFE group). Indications, risk factors, previous revascularisation procedures, and runoff vessels were similar in both groups. Thirty day mortality was 6.6% in the vein group and 5.3% in the HePTFE group ( p = .508), early graft occlusion (6.6% vs. 5.3%; p = .508) and 30 day major amputation rate (0% vs. 2.7%; p = .245) were similar between the two groups. Overall primary patency was 51.7% (55.5% [vein group] vs. 51.7% [HePTFE group]; p = .897) and overall secondary patency was 64.2% (74.6% [vein group] vs. 55.6% [HePTFE group]; p = .119), all without significance after 5 years. However, limb salvage (79.1%) was significantly different (90.0% [vein group] vs. 62.9% [HePTFE group]; p = .021). Survival was similar between the groups (47.3% vs. 42.9%; p = .582) as well as MALE free survival (69.4% vs. 55.0%; p = .348). Conclusion Bypasses to the below knee popliteal artery show good results in patients with CLI unsuitable for endovascular therapy. Vein is still the first line graft material.

Background Ischaemic ulcerations have been reported to persist and/or deteriorate despite technically successful revascularisations; a higher incidence of which affects patients with diabetes and critical limb ischaemia. In the context of wound healing, it is unclear if applications of the angiosome concept in ‘direct revascularisation’ (DR) would be able to aid the healing of chronic foot ulcerations better than the current ‘best vessel’ or ‘indirect revascularisation’ (IR) strategy in patients with co-morbid diabetes and critical limb ischaemia. Methods A literature search was conducted in eight electronic databases, namely AMED, CINAHL, The Cochrane Library, ProQuest Health & Medicine Complete, ProQuest Nursing & Allied Health Source, PubMed, ScienceDirect and TRIP database. Articles were initially screened against a pre-established inclusion and exclusion criteria to determine eligibility and subsequently appraised using the Newcastle-Ottawa Scale. Results Five retrospective studies of varying methodological quality were eligible for inclusion in this review. Critical analysis of an aggregated population (n = 280) from methodologically stronger studies indicates better wound healing outcomes in subjects who had undergone DR as compared to IR (p

Background Critical limb ischaemia (CLI) is the end stage of peripheral artery disease (PAD) and is associated with high amputation and mortality rates and poor quality of life. For CLI patients with no revascularisation options, venous arterialisation could be a last resort for limb salvage. Objective To review the literature on the clinical effectiveness of venous arterialisation for lower limb salvage in CLI patients with no revascularisation options. Method Different databases were searched for papers published between January 1966 and January 2016. The criteria for eligible articles were studies describing outcomes of venous arterialisation, published in English, human studies, and with the full text available. Additionally, studies were excluded if they did not report limb salvage, wound healing or amputation as outcome measures. The primary outcome measure was post-operative limb salvage at 12 months. Secondary outcome measures were 30 day or in-hospital mortality, survival, patency, technical success, and wound healing. Results Fifteen articles met the inclusion criteria. The included studies described 768 patients. According to the MINORS score, methodological quality was moderate to poor. The estimated pooled limb salvage rate at one year was 75% (0.75, 95% CI 0.70–0.81). Thirty day or in-hospital mortality was reported in 12 studies and ranged from 0 to 10%. Overall survival was reported in 10 studies and ranged from 54% to 100% with a mean follow-up ranging from 5 to 60 months. Six studies reported on patency of the venous arterialisations performed, with a range of 59–71% at 12 months. Conclusion In this systematic review on venous arterialisation in patients with non-reconstructable critical limb ischaemia, the pooled proportion of limb salvage at 12 months was 75%. Venous arterialisation could be a valuable treatment option in patients facing amputation of the affected limb; however, the current evidence is of low quality.

In this study, we investigated the role of a long non‐coding RNA GAPLINC in angiogenesis using human umbilical vein endothelial cells (HUVEC). We found that hypoxia and hypoxia‐inducible factor 1α (HIF‐1α) increased the expression of GAPLINC in HUVEC cells. Moreover, GAPLINC overexpression down‐regulated miR‐211 and up‐regulated Bcl2 protein expression. Further rescue experiments confirmed that hypoxia directly increased GAPLINC expression. GAPLINC overexpression also increased cell migration and vessel formation which promoted angiogenesis, and these changes were attributed to the increased expression of vascular endothelial growth factor receptors (VEGFR) and delta‐like canonical notch ligand 4 (DLL4) receptors. Finally, we demonstrated that GAPLINC promotes vessel formation and migration by regulating MAPK and NF‐kB signalling pathways. Taken together, these findings comprehensively demonstrate that overexpression of GAPLINC increases HUVEC cells angiogenesis under hypoxia condition suggesting that GAPLINC can be a potential target for critical limb ischaemia (CLI) treatment.

Background and aim of the work: Functional activity may remain limited in patients affected by critical limb ischemia, despite successful infrainguinal lower limb bypass surgery (ILLBS). The aim of the work was to evaluate the impact of a rehabilitative intervention on postoperative ambulatory status and pain. Methods: In an observational study, data were collected on 34 patients undergoing ILLBS for critical limb ischemia or end-stage peripheral arterial disease. All patients underwent a postoperative rehabilitation program aimed at recovering gait autonomy. Information was collected on pre-operative comorbidities, ambulatory status (on admission to and discharge from hospital) and pain in the affected lower limb (on the first physiotherapy session and at discharge). Results: Before ILLBS, 61.8% of the patients walked independently without aids or assistance. The rehabilitative program started on average 5.7 (SD: 2.1) days after surgery. At discharge, 50% of the patients walked independently, 41.2% walked with aids and/or assistance and 8.8% were not able to walk. Overall, 76.5% of the sample recovered their pre-operative ambulatory status. Although pain tended to decrease, the difference at the first (1.5; SD: 2.6) and at the last treatment session (0.8; SD= 1.3) was not statistically significant. Conclusion: Our exercise protocol resulted to be easy to perform during hospital stay, with an overall favourable outcome for ambulatory status. Our results are in line with those reported in literature about the rates of postoperative dependence in walking, but appear to be slightly better in regards to the percentage of patients who recovered pre-operative ambulatory status. (www.actabiomedica.it)

Abstract. Background: The aim of this study was to determine the outcomes of primary bypass graft surgery (BGS) compared to BGS after failed angioplasty (PTA). Patients and methods: Between January 2007 and January 2014, we performed 136 BGSs exclusively for the treatment of critical limb ischaemia. Two cohorts were identified: 1) primary BGS (n = 102; group I), and 2) BGS after prior PTA (n = 34; group II). Data were analysed retrospectively and the primary endpoints were the rates of secondary patency, amputation-free survival, freedom from major adverse outcomes (graft occlusion, amputation, or death), and overall survival, which were assessed with the Kaplan-Meier method. Results: Both groups were comparable with a predominance of Rutherford’s category 5 ischaemic lesions (73.3 %). Most patients had extensive TASC D athe-rosclerotic disease (83.6 %), and the main conduit was the greater saphenous vein (58.1 %). The mean follow-up time was 36.2 months. The 3-year secondary patency rates were better for group I (64.3 % vs 49.6 %; P = 0.04). During the same period, the amputation-free survival rates were similar between the groups (77.4 % vs 74.5 %; P = 0.59). For multivariate Cox regression analysis, BGS after prior PTA was the only factor associated with re-intervention for limb salvage (hazard ratio = 2.39; CI 95 % = 1.19 - 4.80; P = 0.02). At the 3-year point, there were no differences in the overall survival rates (72.6 % vs 70 %; P = 0.97), but the proportion of patients without adverse outcomes was higher in group I (37.3 % vs 13.4 %; P = 0.007). Conclusions: Although secondary patency was better after primary BGS, the amputation-free and overall survival rates support the use of BGS after prior PTA.

The present study investigated the impact of endovascular pedal artery revascularisation (PAR) on the clinical outcomes of patients with critical limb ischaemia (CLI).This retrospective analysis of a single centre cohort included 239 patients who underwent endovascular revascularisation of infrapopliteal arteries for a chronic ischaemic wound. PAR was attempted in 141 patients during the procedure. After propensity score matching, there were 87 pairs of patients with and without PAR.After the matching, the two groups showed balanced baseline clinical and lesion characteristics. PAR was achieved in 60.9% of the PAR group. Direct angiosome flow was more frequently obtained in the PAR group than in the non-PAR group (81.6% vs. 34.5%; p .001). Subintimal angioplasty (47.1% vs. 29.9%; p = .019) and pedal-plantar loop technique (18.4% vs. 0%; p .001) were more frequent in the PAR group. At the one year follow up, the PAR group showed greater freedom from major amputation (96.3% vs. 84.2%; p = .009). The wound healing rate, overall survival, major adverse limb event, and freedom from re-intervention did not differ significantly between the two groups. However, the patient subgroup with successful PAR showed a higher wound healing rate than the non-PAR group (76.0% vs. 67.0%; p = .031). In a multivariable Cox proportional hazards regression model, successful PAR (hazard ratio [HR] 1.564, 95% confidence interval [CI] 1.068-2.290; p = .022) was identified as an independent factor associated with improved wound healing, whereas gangrene (HR 0.659, 95% confidence interval [CI] 0.471-0.923; p = .015), C reactive protein3 mg/dL (HR 0.591, 95% CI 0.386-0.904; p = .015), and pre-procedural absence of pedal arch (HR 0.628, 95% CI 0.431-0.916; p = .016) were associated with impaired wound healing.Successful PAR significantly improved wound healing in patients with CLI. Thus, efforts should be made to revascularise the pedal arteries, especially when the pedal arch is completely absent.

OBJECTIVES: End-stage renal disease (ESRD) patients with peripheral arterial disease (PAD) are at high risk for complications following open surgical revascularization (OSR). Endovascular revascularization (ER) is an option, but its role is unclear. We sought to characterize the outcomes of ER and OSR in ESRD patients treated for claudication or critical limb ischemia (CLI). METHODS: We used the United States Renal Data System to investigate outcomes after lower extremity ER and OSR from 2005–2011. Primary outcomes were mortality, amputation, and periprocedural myocardial infarction (MI). We generated Kaplan-Meier (K-M) estimates for mortality and amputation, logistic regression models for 30-day predictors, and proportional hazards models for long-term predictors. RESULTS: A total of 20,347 patients underwent OSR and ER (20.3% OSR, 79.7% ER). CLI was the indication in 80.8% of ER and 88.4% of OSR. Unadjusted major amputation rate at 30 days was higher after ER compared to OSR (8.8% vs 6.4%, P

Clopidogrel is a pro-drug requiring cytochrome P450 (CYP) 2C19 enzyme to be oxidised to its active form. This study evaluated the association between the CYP 2C19 genetic polymorphism and clinical outcomes in patients with critical limb ischaemia (CLI) taking clopidogrel after endovascular therapy (EVT).This was a retrospective study. Patients with CLI who had undergone EVT between August 2014 and January 2017 were included. The study subjects were divided into three groups according to the loss of function (LOF) CYP2C19 alleles: (1) extensive metaboliser (EM); (2) intermediate metaboliser (IM); and (3) poor metaboliser (PM). All patients underwent a platelet function test (VerifyNow). Amputation free survival and all cause mortality were estimated using the Kaplan-Meier method. The association between baseline characteristics and clinical outcomes was assessed with the Cox proportional hazard model.A total of 278 CLI patients (EM: 153, IM: 79, PM: 46) who underwent EVT were included. There were 180/278 (64.7%, EM: 107, IM: 45, PM: 28) patients who completed the 12 month follow up examination. Carriers of at least one CYP2C19 LOF allele (44.9%, 125/278) had diminished pharmacodynamic responses to clopidogrel as measured using VerifyNow (174 ± 27 platelet reactivity units (PRU), 216 ± 21 PRU, and 245 ± 35 PRU for patients with EM, IM, and PM CYP2C19 profiles, respectively; EM vs. IM, p .0001 and EM vs. PM, p .0001). The estimated amputation free 12 month survival rates were EM 82.1%, IM 66.1.0%, and PM 56.6% with significant differences between groups (log-rank test p = .0006, p for trend.0001). The estimated all cause 12 month mortality rates were EM 83.7%, IM 72.2%, and PM 71.3% (log rank test p = .01, p for trend p = .007). The combined group consisting of IM and PM was associated with amputation free survival and all cause mortality based on a univariable analysis (hazard ratio [HR] = 2.23 [1.97-2.46], p = .011; HR = 1.43 [1.05-1.85], p = .043) and remained significant in a multivariable Cox analysis (HR = 2.65 [2.1-2.9], p = .009; HR = 1.39 [1.07-1.74], p = .037).CYP2C19 genetic profiles can significantly influence clinical outcomes (in both amputation free survival and all cause mortality) in CLI patients who are taking only clopidogrel after EVT.

Objective/Background In critical limb ischaemia (CLI), current guidelines recommend revascularisation whenever possible, preferentially through endovascular means. However, in the case of long occlusions or failed endovascular attempts, distal bypasses still have a place. Single segment great saphenous vein (GSV), which provides the best conduit, is often not available and currently there is no consensus about the best alternative graft. Methods From January 2006 to December 2015, 42 cryopreserved arterial allografts were used for a distal bypass. Autologous GSVs or alternative autologous conduits were unavailable for all patients. The patients were observed for survival, limb salvage, and allograft patency. The results were analysed with Kaplan–Meier graphs. Results Estimates of secondary patency at one, two and five years were 81%, 73%, and 57%, respectively. Estimates of primary patency rates at one, two and five years were 60%, 56%, and 26%, respectively. Estimates of limb salvage rates at one, two and five years were 89%, 89%, and 82%, respectively. Estimates of survival rates at one, two and five years were 92%, 76% and 34%, respectively. At 30 days, major amputations and major adverse cardiac events were one and zero, respectively. Six major amputations occurred during the long-term follow up. Conclusion Despite a low primary patency rate at two years, the secondary patency of arterial allografts is acceptable for distal bypasses. This suggests that cryopreserved arterial allografts are a suitable alternative for limb saving distal bypasses in the absence of venous conduits, improving limb salvage rates and, possibly, quality of life.

Abstract. Background: Microarray analysis has been carried out in this pilot study to compare delineated gene expression profiles in the biopsies of skeletal muscle taken from patients with chronic critical limb ischaemia (CLI) and non-ischaemic control subjects. Patients and methods: Biopsy of gastrocnemius muscle was obtained from six patients with unreconstructed CLI referred for surgical major amputation. As control, biopsies of six patients undergoing elective knee arthroplasty without evidence of peripheral arterial occlusive disease were taken. The differences in gene expression associated with angiogenic processes in specimens obtained from ischaemic and non-ischaemic skeletal muscle were confirmed by quantitative real-time polymerase chain reaction (PCR) analysis. Results: Compared with non-ischaemic skeletal muscle biopsy of chronic-ischaemic skeletal muscle contained 55 significantly up-regulated and 45 down-regulated genes, out of which 64 genes had a known genetic product. Tissue samples of ischaemic muscle were characterized by increased expression of cell survival factors (e. g. tissue factor pathway inhibitor 2) in combination with reduced expression of cell proliferation effectors (e. g. microfibrillar-associated protein 5 and transferrin receptor). The expression of growth factors (e. g. early growth response 3 and chemokine receptor chemokine C-X-C motif ligand 4) which play a central role in arterial and angiogenic processes and anti-angiogenetic factors (e. g. pentraxin 3) were increased in chronic ischaemic skeletal muscle. An increased expression of extracellular matrix proteins (e. g. cysteine-rich angiogenic inducer 61) was also observed. Conclusions: Gene expression profiles in biopsies of gastrocnemius muscle in patients with chronic critical limb ischaemia showed an increase in pro-survival factors, extracellular matrix protein deposition, and impaired proliferation, compared with non-ischaemic controls. Further studies are required to analyse the endogenous repair mechanism.

ObjectivesTo evaluate the budget impact of progressive replacement of standard polytetrafluoroethylene (PTFE) grafts by heparin-bound PTFE (Propaten) for below-the-knee (BTK) bypass in patients with critical limb ischaemia (CLI).DesignFrom a review of the scientific literature, we calculated a theoretical BTK primary patency for Propaten grafts. Using the French hospital expenditure database (PMSI), we retrospectively estimated a rehospitalisation rate for standard PTFE grafts. From these data, a model was created to assess the budget impact of a progressive replacement from standard PTFE grafts to Propaten grafts over a 5-year horizon. We performed an univariate sensitivity analysis to assess the robustness of our results.SettingFrench National Health Insurance (FNHI) perspective.ParticipantPatients with CLI.Main outcome measuresBudget impact analysis.ResultsData extraction from the PMSI revealed that 656 patients were treated with PTFE grafts in 2011 in French public hospitals for a BTK bypass. Assuming a 2-year survival rate of 76.8%, observed reinterventions rate for standard PTFE grafts at 24 months from the PMSI was 35.1%. The mean rehospitalisation cost was €10 689. The budget impact analysis based on these data found a net cumulative 5-year payer budget reduction of €112 420 in favour of Propaten, under the assumption of a 75.6% primary patency for Propaten grafts for a projected population of 3215 patients of which 801 received a Propaten graft.ConclusionsOur budget impact analysis showed a positive impact on the national health insurance budget of the replacement of standard PTFE grafts by Propaten grafts for BTK bypass in patients with CLI in France. This supports the enactment of a reimbursement policy by the FNHI.

Many people with critical limb ischaemia have no option but to have the affected limb amputated. Can regenerative medicine offer an alternative?

The "angiosome" concept as a model for decision making in revascularisation of patients with critical limb ischaemia (CLI) has been subject to lively discussion in recent years. The aim of this prospective pilot study was to use intra-operative fluorescence angiography to provide further data on the angiosome concept on the level of microcirculation after tibial bypass surgery.This was a prospective analysis of 40 patients presenting with CLI Rutherford stage IV to VI before and after tibial bypass surgery. The macrocirculation was measured by the ankle brachial index. Skin microcirculation was assessed by intra-operative fluorescence angiography. The alteration of microcirculation was compared in direct and indirect revascularised angiosomes. Clinical follow-up investigations were performed and the wound healing rate was compared between the different revascularisation methods.Cumulated microcirculation parameters showed a significant improvement after surgery (ingress, ingress rate p.001). Likewise, general microcirculatory improvement was observed in each foot angiosome after revascularisation, regardless of the tibial artery revascularised. Furthermore, a comparison of the direct (DR) and the indirect revascularised (IR) angiosomes did not show a significant difference concerning the improvement of microcirculation (difference DR-IR, ingress: 1.69, 95% CI 71.73-75.11; ingress rate: 0.08, 95% CI -12.91 to 13.07). The wound healing rate was similar in both groups, although the time to wound healing was faster by on average 2.5 months in the DR group (p=.083).Microcirculatory improvement was seen over the whole foot after tibial bypass. Therefore, fluorescence angiography is a promising tool to evaluate the angiosome concept in future larger studies. Clinicaltrials.gov: NCT03012750.

Background Numerous drugs have been proposed to alleviate ischaemic limb pain, but none have been successful in relieving ischaemic pain thoroughly and rapidly. Objective To compare the effectiveness of intravenous lidocaine and intravenous morphine in decreasing pain in patients with critical limb ischaemia. Methods A randomised double-blind controlled trial was performed in 63 patients with critical limb ischaemia recruited from the emergency department between October 2012 and December 2013; 23 patients were excluded and the remainder were randomly divided into two groups of 20 patients. Patients in the lidocaine group received lidocaine infusion (2 mg/kg) while patients in the morphine group received morphine (0.1 mg/kg). Patients’ visual analogue pain scores (VAS), from 0 to 10, were reported before and 15 and 30 min after the infusion. Results Before the infusion the mean±SD VAS score was 7.50±1.93 in the lidocaine group and 7.65±1.92 in the morphine group. At 15 min the mean±SD VAS score in the lidocaine group was lower than in the morphine group (5.75±1.77 vs 7.00±1.83; mean difference 1.25, 95% CI 0.095 to 2.405) and, at 30 min, the mean±SD VAS score in the lidocaine group was again lower (4.25±1.48 vs 6.50±1.73; mean difference 2.25, 95% CI 1.218 to 3.282). Conclusions Lidocaine may be helpful in decreasing ischaemic pain in patients with critical limb ischaemia. Trial registration number http://www.irct.irIRCT201210148872N2.

Objective Despite the popularity of endovascular therapy (EVT) for critical limb ischaemia (CLI), there are few studies investigating the efficacy of duplex ultrasound (DUS) surveillance after endovascular interventions. The aim of this study was to evaluate DUS surveillance after EVT for CLI. Methods 146 endovascular procedures in 134 consecutive patients with CLI between 2011 and 2012 were included. Follow-up visits with ankle-brachial index (ABI), toe pressure, and target vessel DUS were performed at 1, 3, and 6 months after revascularisation. Results The median age of the study population was 79 years, 58% were males, and 55% had diabetes. The target artery was at the iliac, femoro-popliteal, and infrapopliteal level in 2%, 54%, and 44% of cases, respectively. There were 282 follow-up visits. In 15 (5.3%) DUS examinations, the target vessel was not seen properly. In the remaining 267 DUS, the majority of the target arteries were patent with no or mild restenosis (n = 169, 63.3%), but in 98 (36.7%) examinations, the target artery was stenosed or occluded. When DUS was compared with the clinical presentation, there was no correlation in 30% and when DUS and toe pressure were compared, discrepancy was seen in 29%. A re-angiogram was performed for 29 patients, and the DUS finding was verified in each case. During the mean follow-up of 11 months, a new endovascular intervention was performed on 37 (25.3%) limbs, and 4 (2.7%) underwent surgical bypass. Four (3.0%) patients died and 6 (4.5%) underwent major amputation. Conclusion Clinical status or toe pressure alone were adequate markers of endovascular revascularisation failure in the majority of the patients, but would have missed up to one-third of the clinically significant restenoses or occlusions. DUS is therefore a valuable aid in surveillance after EVT for CLI, especially for patients with an ischaemic tissue lesion.

Objective The study aims to assess a novel thermosensitive polymer (LeGoo ® ) for distal vessel control during infra-popliteal (crural/pedal) bypass surgery in severe leg ischaemia. Method Retrospective analysis of all distal bypasses from October 2009 to February 2012. Technical success, patency, limb salvage and amputation-free survival rates were analysed. Results Fifty-four infra-popliteal bypasses using the polymer were performed in 46 patients. The distal anastomosis was at the anterior tibial ( n = 15, 28%), posterior tibial ( n = 12, 22%), peroneal ( n = 8, 15%), tibio-peroneal trunk ( n = 8, 15%) and dorsalis pedis arteries ( n = 11, 20%). Technical success was achieved in 51/54 (94.4%; failures: two inadequate haemostasis, one un-dissolved polymer). In-hospital duplex of the distal anastomosis showed a significant stenosis in two cases (4.3%). Outflow angioplasty was performed in three cases (two distal anastomotic, one run-off vessel, 5.6%). The 1-year patency rate was 76.2% (standard error (SE) 6.7%), limb salvage rate 79.3% (SE 6.7%). Amputation-free survival was 93.5% at 30 days (SE 3.6%) and 67.5% at 1 year (SE 7.5%). Conclusion This thermosensitive polymer is a potentially safe and useful atraumatic device to achieve a blood-less distal anastomotic field in infra-popliteal bypasses. The technique avoids other potentially traumatic methods of vessel control, which may be particularly important in patients with calcified distal vessels.

Aims and objectives To examine the domains and the domain-specific characteristics within a peripheral arterial disease health-related quality of life framework for their usefulness in defining critical limb ischaemia health-related quality of life. Background Critical Limb Ischaemia presents a highly individualised set of personal and health circumstances. Treatment options include conservative management, revascularisation or amputation. However, the links between treatment decisions and quality of life require further investigation. Design The framework for this integrative review was the peripheral arterial disease-specific health-related quality of life domains identified by Treat-Jacobson et al. Results The literature expanded and refined Treat-Jacobson's framework by modifying the characteristics to better describe health-related quality of life in critical limb ischaemia. Conclusions Given that critical limb ischaemia is a highly individualised situation with powerful health-related quality of life implications, further research focusing on patient and family-centred decision-making relating to therapeutic options and advanced care planning is required. Relevance to clinical practice A critical limb ischaemia-specific, health-related quality of life tool is required to capture both the unique characteristics of this disorder, and the outcomes for active or conservative care among this complex group of patients.

We report a novel application of balloon angioplasty to recanalise a chronically occluded remote endarterectomy superficial femoral artery. This patient previously had two occluded surgical bypass grafts in an attempt to revascularise the limb and presented with critical limb ischaemia and necrotic foot ulcerations. Following the angioplasty, the patient showed significant improvement in rest pain and healing of the ulcerations. This technique may be useful for limb salvage in patients where surgical options have been exhausted.

Background Severe limb ischaemia (SLI) is defined as the presence of rest pain and/or tissue loss secondary to lower extremity atherosclerotic peripheral arterial disease. The superficial femoral and popliteal arteries are the most commonly diseased vessels in such patients and are being increasingly treated using endovascular revascularisation techniques. However, it is currently unknown whether drug-eluting stents and drug-coated balloons confer additional clinical benefits over more established techniques using plain balloons and bare metal stents, or whether they represent a cost-effective use of NHS resources. Methods The BASIL-3 trial is a UK National Institute for Health Research, Health Technology Assessment Programme-funded, multicentre, randomised controlled trial (RCT) comparing the clinical and cost-effectiveness of plain balloon angioplasty with or without bail-out bare metal stenting, drug-coated balloon angioplasty with or without bail-out bare metal stenting, and primary stenting with drug-eluting stents for SLI secondary to femoro-popliteal disease. Patients with ‘multilevel’ disease may receive aorto-iliac and/or infrapopliteal treatments concurrently with their randomised femoro-popliteal intervention. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the index limb or death from any cause. The primary outcome for the economic analysis is cost per quality-adjusted life year. Secondary outcome measures include overall survival, major adverse limb events, major adverse cardiac events, relief of ischaemic pain, healing of tissue loss, and quality of life. The required sample size has been calculated at 861 participants (287 on each arm). These patients will be recruited over 3 years and followed-up for between 2 and 5 years. Discussion BASIL-3 is a pragmatic RCT designed to reflect current UK clinical practice. The results will inform decision-making regarding the appropriateness of funding the use of drug-coated balloons and drug-eluting stents, by the NHS, for the management of SLI due to femoro-popliteal disease. Trial registration ISRCTN Registry, identifier: ISRCTN14469736. Registered on 22 October 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1968-6) contains supplementary material, which is available to authorized users.

Objectives: The number of elderly people is increasing; inevitably, the result will be more patients with critical limb ischaemia (CLI) in the future. Tissue loss in CLI is related to a high risk of major amputation. The aim of this study was to analyze the treatment process from referral to revascularisation, to discover possible delays and reasons behind them, and to distinguish patients benefitting the most from early revascularisation. Methods: A retrospective analysis was performed of 394 consecutive patients with a combined 447 affected limbs, referred to the outpatient clinic during 2010-2011 for tissue loss of suspected ischaemic origin. Results: For 246 limbs revascularisation was scheduled. After changes in the initial treatment strategy, endovascular treatment (ET) was performed on 221 and open surgery (OS) on 45 limbs. Notably there was crossover after ET in 17.0% of the procedures, and re-revascularisations were required in 40.1% after ET and 31.1% after OS. The median time from referral to revascularisation was 43 days (range 1-657 days) with no significant difference between ET and OS. For 29 (11.8%) patients the ischaemic limb required an emergency operation scheduled at the first visit to the outpatient clinic. For 25 (10.2%) patients the situation worsened while waiting for elective revascularisation and an emergency procedure was performed. Diabetic patients formed the majority of the study population; with 159 diabetic feet undergoing revascularisation. In multivariate analysis, diabetes was associated with poor limb salvage. When revascularisation was achieved within 2 weeks, no difference was seen in limb salvage. However, when the delay from first visit to revascularisation exceeded 2 weeks, limb salvage was significantly poorer in diabetic patients. Conclusions: Diabetic ulcers always require vascular evaluation, and when.ischaemia is suspected the diagnostics should be organised rapidly to ensure revascularisation without delay, according to this study within 2 weeks from the first evaluation. (C) 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

International guidelines recommend revascularisation as the preferred treatment for patients with critical limb ischaemia (CLI). Most contemporary research focuses on the outcome of invasive procedures for CLI, but little is known about the outcome of conservative management. Amputation free survival (AFS) and overall survival (OS) was investigated in patients with CLI who did or did not receive revascularisation, and characteristics associated with clinical outcomes were explored. This was a retrospective cohort study of consecutive patients with chronic CLI between 2010 and 2014 in a Dutch university hospital. CLI was defined as the presence of ischaemic rest pain or tissue loss in conjunction with an absolute systolic ankle pressure < 50 mmHg or a toe pressure < 30 mmHg. Patients were divided into invasive (revascularisation within 6 weeks), deferred invasive (revascularisation after 6 weeks), or permanently conservative treatment groups. Univariable and multivariable survival analyses were used to identify factors associated with AFS and OS. The majority (66.7%; N = 96) of the identified 144 patients with CLI (mean age 71.2 years; median follow-up 99 weeks) underwent revascularisation within 6 weeks of diagnosis. Deferred invasive treatment was provided in 18.1% (N = 26) patients and 22 patients (15.3%) were treated permanently conservatively. AFS and OS did not differ significantly between the three groups (Breslow-Wilcoxon p = .16 for AFS and p = .09 for OS). Age, chronic obstructive pulmonary disease (COPD), and heart disease were significant independent predictors of AFS. Age, COPD, and hypertension were significant independent predictors of OS. Treatment was not a significant predictor of either AFS or OS. Not all patients with CLI require revascularisation to achieve an AFS that is similar to patients undergoing revascularisation, although the efficacy of conservative versus invasive treatment in CLI patients is still unclear. Further prospective studies should determine subgroups of patients in whom revascularisation may be omitted

Objectives We wanted to compare autonomy recovery after open and endovascular infrainguinal surgery for critical limb ischaemia (CLI) in octogenarians. Materials and methods We performed a retrospective analysis of 167 consecutive CLI octogenarians who underwent infrainguinal open surgery (OS) or endovascular surgery (ES) between 2003 and 2008. OS and ES groups were compared in terms of autonomy level (Parker score), survival, limb salvage and patency rates. Results Preoperative autonomy level was similar in both groups (OS n = 109, ES n = 58) but 6-month postoperative autonomy level was better after ES ( p = 0.01). There was a trend towards better survival after OS (74% at 1 year, 62% at 2 years, 32% at 4 years with OS and 68%, 50%, 17% respectively for ES p = 0.06), but no difference regarding limb salvage (91% at 1 year, 90% at 2 years, 89% at 4 years for OS and 94%, 87%, 86% respectively for ES, p = 0.939) and primary patency (76% at 1 year, 59% at 2 years, 50% at 4 years for OS and 82%, 75%, 32% respectively for ES, p = 0.467). Conclusions ES is justified in CLI octogenarians, because it allows restoring a higher autonomy level, with limb salvage and patency rates comparable to OS.

This is a narrative review on vascular assessment for critical limb ischaemia in the past and present combining Finnish and Japanese experience.

Objectives More traditional outcome measures following lower limb bypass procedures are poor predictors of functional outcome. This paper aimed to review the effect of infrainguinal bypass surgery on residential and mobility status in patients with critical limb ischaemia. Design Review. Methods A Medline search up until April 2011 was undertaken of all studies involving patients with CLI undergoing ILLB and PTA. Studies were reviewed if they addressed the ambulatory/residential status of the patients pre- and post-operatively. Ambulatory status was defined as the ability to walk even with the help of a stick/frames. Independent residential status was defined as living at home with no help. Results A total of 10 studies on IILB were deemed suitable for inclusion in the review, reporting 3381 patients (2064 men). Median age ranged from 66 years to 84 years. Thirty day mortality ranged from 0% to 6.3%. Follow-up ranged from 30 days to 1 year. Three studies noted an improvement in ambulation status. No study reported any improvement in residential status after ILLB. Only one study reported on specific improvements in ambulatory status in patients with CLI after PTA. Conclusions ILLB for patients with CLI is not without risk. Patients are not as independent or mobile following surgery. Further studies need to firstly identify the cause(s) of this and to determine optimal methods to return more patients to independence. Furthermore, CLI studies need to routinely report data on functionality.

ObjectivesTo assess and risk stratify midterm clinical outcomes after endovascular therapy (EVT) by angioplasty only of patients with critical limb ischaemia (CLI) due to isolated below-the-knee (BTK) lesions.DesignRetrospective multicenter study.Materials and methodsBetween March 2004 and October 2010, 465 limbs (Rutherford 5 and 6: 79%) from 406 patients were studied. Overall survival, limb salvage, and re-intervention were examined out to 3 years by the Kaplan–Meier method and the log-rank test. Their independent predictors and risk stratification were analysed.ResultsPatient age was 71 ± 11 yrs, with 69% diabetics and 60% on dialysis. Mean follow-up was 18 ± 15 months. Overall survival was 76 ± 2 and 57 ± 4% at 1 and 3, years, respectively. Survival predictors were body mass index 5 mg/dL, and age

Negative pressure wound therapy (NPWT) is a useful wound dressing that can be applied to a wide variety of wounds. Patients with ischaemic wounds, however, may experience further necrosis with NPWT at the commonly recommended pressure of -125 mm Hg. We hypothesized that with a suction pressure of -125 mm Hg, tissue pressure will likely occlude most of the capillaries adjacent to the wound edge. Therefore, we treated three patients with ischaemic wounds using low-pressure NPWT at -50 mm Hg. All wounds healed successfully without further necrosis at the wound edge.

Objectives To evaluate initial treatment and risk factors for amputation-free survival in patients with critical limb ischaemia (CLI). Design Prospective clinical cohort study at a single vascular surgical centre in Germany. Methods Data on 104 consecutive patients (115 ischaemic limbs) presenting with their first episode of CLI were collected prospectively over a 3-year period. Initial treatment was classified as conservative therapy, intervention, surgery, or major amputation. Patient co-morbidities were assessed by uni- and multivariate analysis to determine risk factors for limb salvage, survival and amputation-free survival. Results Indications for treatment were rest pain in 27 (23.5%) and tissue loss in 88 (76.5%) limbs. Revascularisation was attempted in 65% of all limbs: 45% by intervention and 55% by surgery. In 9% primary amputation was necessary and 22% received conservative therapy. Median follow-up was 28 months (1–42). The 3-year limb salvage, patient survival, and amputation-free survival rates were 73%, 41%, and 31%, respectively. Diabetes, cardiac disease and renal insufficiency were associated with poor survival. Combined cardiac and renal disease adversely affected amputation-free survival (HR, 3.68; 95% CI, 1.51–8.94; P Conclusions At least two third of all patients presenting with CLI can be offered some type of direct revascularisation. In patients with major cardiac disease and renal insufficiency, a poor outcome in terms of amputation-free survival is to be anticipated.