Search

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications. [ABSTRACT FROM AUTHOR]

To assess the comparative effectiveness and temporal changes in quality of life (QoL) outcomes after revascularisation, major lower extremity amputation (MLEA), and conservative management (CM) in chronic limb threatening ischaemia (CLTI). MEDLINE, Embase, PsycINFO, CINAHL, and Web of Science. A systematic review and meta-analysis were performed on QoL measured by any QoL instrument in adult patients with CLTI after open surgery (OS), endovascular intervention (EVI), MLEA, or CM. Randomised controlled trials and prospective observational studies published in any language between 1 January 1990 and 21 May 2021 were included. There was a pre-specified measurement time point of six months. Random effects meta-analysis was conducted on total scores for each QoL instrument. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach (PROSPERO registration: CRD42021253953). Fifty-five studies with 8 909 patients were included. There was significant heterogeneity in the methods used to measure QoL, and the study characteristics. In particular, 14 different QoL instruments were used with various combinations of disease specific and generic instruments within each study. A narrative summary is therefore presented. Comparative effectiveness data showed there was reasonable certainty that QoL was similar between OS and EVI at six months. Temporal outcomes suggested small to moderate improvements in QOL six months after OS and EVI compared with baseline. Limited data indicated that QoL can be maintained or slightly improved after MLEA or CM. Treatment effects were overestimated owing to small study effects, selective non-reporting, attrition, and survivorship bias. QoL after OS and EVI appears to be similar. Revascularisation may provide modest QoL benefits, while MLEA or CM can maintain QoL. However, certainty of evidence is generally low or very low, and interpretation is hampered by significant heterogeneity. There is a need for a CLTI specific QoL instrument and methodological standardisation in QoL studies. [ABSTRACT FROM AUTHOR]

Great efforts have been made to choose between bypass surgery and angioplasty as the first choice for revascularisation in chronic limb threatening ischaemia (CLTI). Endovascular therapy predominates despite limited evidence for its advantages. The purpose of this observational cohort study was to investigate outcomes after open and endovascular infrapopliteal revascularisation in extensive infrainguinal arterial disease. The medical records of 1 427 patients who underwent infrainguinal revascularisation exclusively for CLTI in the period January 2014 to February 2019 were reviewed. After detailed analysis, only infrapopliteal revascularisations classified as GLASS stage II or III were considered, resulting in 326 procedures. In total, 127 patients underwent endovascular therapy and 199 patients underwent bypass graft surgery (BGS). The primary endpoints included amputation free survival (AFS) and overall survival (OS). Secondary endpoints included the analyses of multiple factors related to long term AFS. Regarding the primary endpoint, AFS was 75.2% and 65.2% at one and three years, respectively. OS at one and three years was 91.2% and 83.1%, respectively. In the univariable analysis, the hazard of the combined endpoint of major amputation or death was higher after bypass surgery than after endovascular therapy (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.13 – 2.89; p =.013). After either revascularisation method, TASC II femoropopliteal D was associated with a higher risk of amputation or death (HR 1.69, 95% CI 1.10 – 2.58; p =.015). Multivariable Cox regression analysis revealed no association between the variables analysed for AFS. Patients with CLTI submitted to infrapopliteal revascularisation and classified as GLASS II and III had satisfactory AFS and OS rates after an individualised team conference decision. Furthermore, the revascularisation modality (endovascular or open) did not influence the AFS results. [ABSTRACT FROM AUTHOR]

Obesity is a significant risk factor for atherosclerotic cardiovascular disease; however, the "obesity paradox", in which obese patients enjoy superior survival, has been observed in various cardiovascular conditions. Whether this phenomenon exists for peripheral artery disease (PAD) remains uncertain. The goal of this study was to evaluate the relationship between body mass index (BMI) and mortality in patients with PAD. A comprehensive literature search identified seven eligible cohort studies that reported the association between BMI and all cause mortality in patients with PAD. A dose response meta-analysis was done for all cause mortality, short term (30 day or in hospital) mortality and long term mortality. The dose response association between BMI and mortality was also assessed in patients who received endovascular therapy (EVT). The non-linear dose response analysis showed that higher BMI values were associated with a lower mortality risk from the range between 15 kg/m2 to approximately 33 – 34 kg/m2. The risk of mortality increased slightly thereafter. This relationship was consistent with that of long term mortality but was not apparent in short term mortality. A U shaped relationship was also observed between BMI and mortality in patients who received EVT with the lowest mortality observed at around 30 kg/m2. The obesity paradox was evident in the analysis of long term survival among patients with PAD, with the lowest mortality rates observed in obese patients. However, this association was not observed for short term or in hospital mortality. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate changes in transcutaneous oxygen pressure (tcpO 2) and systolic toe pressure (TP) during endovascular intervention. This was a single centre prospective, non-randomised, observational feasibility study. Patients with chronic limb threatening ischaemia (CLTI) due to infrainguinal disease scheduled for endovascular treatment were included between March 2018 and December 2019. TcpO 2 was measured continuously bilaterally at foot level throughout the procedure and at follow up. Specific time points during the intervention were chosen for comparison to baseline (before arterial puncture): average tcpO 2 level five minutes prior to percutaneous transluminal angioplasty (PTA); 10 minutes after PTA; and at completion. Bilateral TP was recorded using laser Doppler flowmetry before arterial puncture, at completion, and at clinical follow up. Angiograms were analysed for successful revascularisation and vascular lesions classified according to the Global Limb Anatomical Scoring System (GLASS). Rutherford and WIfI (Wound, Ischaemia, and foot Infection) classifications were registered, as well as clinical outcome. Twenty-one patients completed the study. Completion angiograms showed inline flow to the foot in all but two patients. Median time to follow up was 10 weeks (range 8 – 13 weeks) and all patients except one improved clinically. TcpO 2 decreased during the initial stage of the intervention, from before arterial puncture to five minute average before PTA (p <.001) and did not recover to above baseline values at the end of intervention. TcpO 2 increased significantly at follow up (p <.001). TP increased statistically significantly during intervention (p <.001) and at follow up (p <.001) compared with baseline. TcpO 2 and TP measurements are safe and feasible non-invasive techniques for haemodynamic monitoring during endovascular revascularisation. TP increased significantly immediately after completion of the successful intervention, whereas tcpO 2 did not. Both TP and tcpO 2 demonstrated a significant increase at the 10 week follow up. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

Antegrade crossing techniques via transfemoral access are often challenging and may be associated with technical and clinical failure when treating patients with critical limb ischaemia (CLI). The objective of this study was to summarise all available literature regarding retrograde endovascular treatment of patients with CLI and to investigate the technical success and complication rate of retrograde access. A systematic literature search was performed in PubMed, Scopus, and Cochrane Central until May 2020. A meta-analysis of 31 observational studies (29 retrospective and two prospective; 26 and five studies with low and moderate risk of bias, respectively) was conducted with random effects modelling. The incidence of adverse events peri-procedurally and during follow up were calculated. The 31 studies enrolled 1 910 patients who were treated endovascularly for femoropopliteal and/or infrapopliteal lesions causing CLI. Most of the patients had diabetes while more than half of the overall population had coronary artery disease and dyslipidaemia. All lesions were located in the infra-inguinal segment and most were chronic total occlusions (96%; 95% CI 85%–100%). Seven studies reported moderate or severe calcification in approximately half of the cases (45%; 95% CI 30%–60%). The overall technical success of the retrograde approach was 96% (18 studies; 95% CI 92%–100%). Perforation, flow limiting dissection, distal embolisation, and local haematoma at the retrograde access site were infrequent and observed in 2.1%, 0.6%, 0.1%, and 1.3% of the patients, respectively. The six month primary patency rate was 78% (five studies; 95% CI 46%–99%), the six month limb salvage rate was 77% (four studies; 95% CI 70%–84%). The results indicated that the retrograde or bidirectional antegrade/retrograde approach is safe and effective and facilitates angioplasty when antegrade treatment fails. However, prospective studies with standardised wound care and surveillance protocols are needed to investigate retrograde techniques in patients with CLI who failed antegrade revascularisation, to improve long term limb salvage and survival. [ABSTRACT FROM AUTHOR]

The Global Vascular Guideline on chronic limb threatening ischaemia (CLTI) has introduced the Global Limb Anatomic Staging System (GLASS) as a new angiographic scoring system. However, the relationship between GLASS and outcomes following revascularisation has not previously been studied. Using pre-intervention angiograms the relationship between GLASS and immediate technical failure (ITF), amputation free survival (AFS), limb salvage (LS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) was examined in 377 patients undergoing endovascular therapy (EVT, n = 213) or bypass surgery (BS, n = 164) in the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-1 trial (randomised 1999–2004). There was no significant difference in GLASS between cohorts. There was a significant relationship between ITF and GLASS in EVT (I 14%, II 15%, III 28%, p =.049). GLASS was significantly related to AFS (hazard ratio [HR], 1.37; 95% CI 1.01–1.85; p =.042), LS (HR 1.96; 95 % CI 1.12–3.43; p =.018), and FF-MALE (HR 1.49; 95% CI 1.04–1.87; p =.028) in the EVT cohort. In BS patients, there was no relationship between GLASS and these outcomes. FF-MALE was significantly worse after EVT than BS in GLASS II (p =.038) and III (p =.001). Among the subgroup of patients with femoropopliteal (FP) disease (BS, n = 109 or EVT, n = 159), FF-MALE was significantly higher after BS than EVT (p <.001). The superiority of BS over EVT with increasing GLASS FP grade was greater in the analysis of patients using vein grafts. In the BASIL-1 cohort, GLASS is associated with outcomes following EVT but not BS. Although further validation in contemporary CLTI cohorts is required, GLASS seems likely be useful in shared decision making and for stratifying patients in future trials. [ABSTRACT FROM AUTHOR]

Delirium is associated with adverse outcomes, such as increased mortality and prolonged hospital stay. Information on the risk factors for delirium in elderly patients with critical limb ischaemia (CLI) is scarce. The aim of this study was to analyse the incidence of delirium and to identify risk factors for delirium in elderly patients undergoing surgical or endovascular treatment. A retrospective cohort study was conducted including patients aged ≥ 65 years undergoing surgical or endovascular treatment for CLI between January 2013 and June 2018. Delirium was scored using the DOSS (Delirium Observation Screening Scale) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria. Risk factors for delirium were analysed using logistic regression. The discriminative ability of the model was calculated using the area under the receiver operating characteristics (AUROC) curve. In total, 392 patients were included, of which 70 (17.9%) developed delirium. Factors associated with an increased risk of delirium were: age, odds ratio (OR) 1.05 (95% confidence interval (CI) 1.0–1.1), history of femoral endarterectomy, OR 4.7 (95% CI 1.5–15), physical impairment, OR 2.2 (95% CI 1.1–4.5), history of delirium, OR 2.7 (95% CI 1.4–5.3), general anaesthesia, OR 2.6 (95% CI 1.2–5.7) and pre-operative anaemia, OR 5.9 (95% CI 2.3–15). The AUROC was.82 (95% CI 0.76–0.87, p <.001). Delirium was associated with more respiratory, renal and surgical complications, as well as a prolonged hospital stay and a more frequent discharge to a nursing home. Delirium occurs frequently in patients with critical limb ischaemia undergoing any type of invasive treatment. This study identified multiple risk factors for delirium that may be helpful to delineate patients susceptible to its development. [ABSTRACT FROM AUTHOR]

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 protein >3 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. [ABSTRACT FROM AUTHOR]

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. 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. The one year wound healing rate was 60.2% in WIfI stage 1–3 patients and 53.6% in WIfI stage 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). 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. [ABSTRACT FROM AUTHOR]

The reports from cohort studies comparing outcomes after revascularisation for chronic limb threatening ischaemia (CLTI) between men and women remain controversial. Anatomical and clinical disease severity is often heterogeneous, and treatment choice influenced by a variety of clinician and patient factors. The aim was to compare outcomes in men and women entered into the only randomised study comparing bypass and angioplasty for infra-inguinal disease causing severe limb ischaemia. Data were obtained from BASIL-1 trial case record forms. Baseline demographics were compared, and Cox proportional hazard models were used to examine the relationship between sex and amputation free survival (AFS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) using a per-protocol analysis. Data were analysed using a per-protocol analysis. A total of 452 patients were randomised into the BASIL-1 trial from 1999 to 2004. At randomisation, women were older and less likely to be smokers, to have diabetes, or to be on recommended best medical therapy. Men were more likely to present with gangrene. Ankle brachial pressure index (ABPI), post-revascularisation length of hospital stay, and 30 day morbidity and mortality were similar for men and women. At three years, female sex was associated with significantly better AFS (HR 0.65, 95% CI 0.47–0.89, p <.01), OS (HR 0.66 95% CI 0.46–0.95, p =.02) and FF-MALE (HR 0.74, 95% CI 0.57–0.96, p =.02). In the BASIL-1 trial, women had similar short term but better long term outcomes after revascularisation. Sex is an important consideration when developing early, evidence based treatment pathway and revascularisation strategies for CLTI, and is an independent risk factor for outcomes following revascularisation as well as development of symptomatic PAD. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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 FROM AUTHOR]

Background Critical limb ischaemia (CLI) is a life threatening condition with a considerable risk of major amputation and death. Besides revascularisation, no treatment has been proven to reduce the risks. Therapeutic angiogenesis by gene or cell therapy has not demonstrated definitive evidence in randomised controlled trials. PLX-PAD is an "off the shelf" allogeneic placental derived, mesenchymal like cell therapy, which, in preclinical studies, has shown pro-angiogenic, anti-inflammatory, and regenerative properties. Favourable one year amputation free survival (AFS), and trends in reduction of pain scores and increase of tissue perfusion have been shown in two small, open label, phase I trials. Methods The PACE study is a phase III randomised, double blind, multicentre, multinational placebo controlled, parallel group study to evaluate the efficacy, tolerability, and safety of intramuscular injections of PLX-PAD cells to treat patients with atherosclerotic CLI with minor tissue loss (Rutherford Category 5) up to the ankle level, who are unsuitable for revascularisation or carry an unfavourable risk benefit for that treatment. The study will enroll 246 patients, who after screening are randomised in a ratio of 2:1 to treatment with intramuscular injections of PLX-PAD 300 × 106 cells or placebo on two occasions, eight weeks apart. The primary efficacy endpoint is time to major amputation or death (amputation free survival), which will be assessed in follow up of at least 12 months and up to 36 months. Conclusions Based on favourable pre-clinical and initial clinical study results, the PACE phase III randomised controlled trial will evaluate placenta derived PLX-PAD cell treatment in patients with critical limb ischaemia, with an unfavourable risk benefit for revascularisation. Clinicaltrials.gov: NCT03006770. [ABSTRACT FROM AUTHOR]

Objectives Patients with infrainguinal peripheral arterial disease often undergo multiple revascularisation procedures. Although many centres have adopted an endovascular first approach, some are reluctant to do so for fear of compromising the outcomes of any subsequent bypasses. All studies that compared the outcomes of primary infrainguinal bypass with bypass after failed endovascular intervention were analysed. Methods A systematic review was conducted of MEDLINE, EMBASE, and CENTRAL databases for studies comparing outcomes of primary infrainguinal bypass with bypass after failed endovascular intervention for peripheral arterial disease. Abstracts and full text studies were screened independently by two reviewers with data abstraction done in duplicate. Dichotomous outcome measures were reported using the OR and 95% CI, and pooled using random effects models. Results Abstracts were screened (2,528), with 50 selected for full text review. Of these, 15 studies involving 11,886 patients met the inclusion criteria. Pooling the results of studies comparing primary bypass with bypass after failed endovascular intervention showed no significant difference in 30 day mortality (OR 1.00; 95% CI 0.65–1.54), or 30 day amputation rates (OR 1.26; 95% CI 0.95–1.65). Interestingly, one year amputation free survival was higher in the patients who had primary bypass (OR 1.30; 95% CI 1.10–1.52) compared with patients who had bypass after failed endovascular therapy. There was also worse one year primary patency (OR 1.65; 95% CI 1.04–2.62) for patients with prior failed endovascular intervention. The review demonstrated a trend towards higher rates of early graft occlusion (OR 4.54; 95% CI 0.97–21.28). Conclusions Meta-analysis of the existing literature comparing primary bypass with bypass following failed endovascular intervention shows worse one year amputation free survival and worse primary patency in those patients who undergo bypass after failed endovascular intervention. There is also a trend towards higher rates of early graft occlusion, although these results were not statistically significant. These conclusions are limited by observational study design, inconsistent patient selection, and significant heterogeneity between studies. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objectives Critical limb ischaemia (CLI) implies an increased risk of cardiovascular morbidity and mortality, and the optimal antithrombotic treatment is not established. Design, Materials, Methods The EUCLID trial investigated the effect of monotherapy with ticagrelor versus clopidogrel in 13,885 patients with peripheral artery disease (PAD); the primary endpoint was cardiovascular death, myocardial infarction, or ischaemic stroke. Patients planned for revascularisation or amputation within 3 months, were excluded. This analysis focuses on the subgroup with CLI, defined by rest pain (58.8%), major (9.0%) or minor (32.2%) tissue loss. Results In EUCLID, 643 patients (4.6%) had CLI at baseline. Diabetes mellitus was more common in the CLI group, while coronary disease, carotid disease, and hypertension were more common in the non-CLI group. A majority of CLI patients (62.1%) had only lower extremity PAD. In patients enrolled on the ankle brachial index (ABI) criteria, ABI was 0.55 ± 0.21 (mean ± SD) for those with CLI versus 0.63 ± 0.15 for those without CLI. The primary efficacy endpoint significantly increased among patients with CLI compared with those without CLI with a rate of 8.85 versus 4.28/100 patient years (adjusted for baseline characteristics hazard ratio [HR] 1.43 [95% CI 1.16–1.76]; p = 0.0009). When acute limb ischaemia requiring hospitalisation was added to the model, significant differences remained (adjusted HR 1.38, [95% CI 1.13–1.69]; p = 0.0016). The 1 year mortality was 8.9%. A trend towards increased lower limb revascularisation among those with CLI was observed. Bleeding (TIMI major, fatal, intracranial) did not differ between those with and without CLI. Conclusions Nearly 5% of patients enrolled in EUCLID had CLI at baseline. Milder forms of CLI dominated, a result of the trial design. Patients with CLI had a significantly higher rate of cardiovascular mortality and morbidity versus those without CLI. Further efforts are required to reduce the risk of cardiovascular events in PAD, especially in patients with CLI. ClinicalTrials.gov NCT01732822 . [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective The aim was to compare outcomes in a subgroup of patients with infrapopliteal (IP) disease randomised to infrapopliteal vein bypass (VB) or plain balloon angioplasty (PBA) in the original BASIL trial. Methods A comparison of outcomes from patients randomised to VB or PBA undergoing revascularisation for severe limb ischaemia (SLI) because of IP disease with or without femoropopliteal disease. Data were extracted from case report forms from the BASIL trial. The primary outcome was amputation free survival (AFS); secondary outcomes included overall survival (OS), 30 day mortality and morbidity, freedom from arterial re-intervention, immediate technical success, repeat and crossover interventions, length of hospital stay, and quality of revascularisation. Results A total of 104 patients were identified in the BASIL study with IP disease, 56 randomised to IP VB, and 48 to IP PBA. Groups were similar at baseline except for more chronic kidney disease and non-steroidal anti-inflammatory drug use in the VB group, and more previous surgical arterial intervention and antihypertensive use in the PBA group. There were no statistically significant differences in AFS or OS; however, clinically important trends were apparent in favour of a VB first strategy. Patients allocated to VB demonstrated significantly quicker relief of rest pain when compared with PBA ( p = .005), but no significant differences in improved tissue healing. Median length of index hospital admission was significantly greater in the VB than in the PBA group (18 vs. 10 days, p < .0001) but there was no difference between the two groups in median total hospital stay between randomisation and the primary endpoint (VB 43.5 vs. PBA 42 days). Conclusions Further randomised trials, like BASIL-2 and BEST-CLI, are required to determine whether patients with severe limb ischaemia who require IP revascularisation and who are suitable for VB should have bypass or endovascular intervention as their primary revascularisation procedure. [ABSTRACT FROM AUTHOR]

Objectives The aim was to assess the efficacy and safety of alprostadil in patients with peripheral arterial occlusive disease (PAOD) Fontaine Stage IV. Methods This was a multinational, prospective, randomised, double blind, placebo controlled, parallel group trial. Patients with Stage IV PAOD were equally randomised to either 4 weeks of alprostadil treatment twice daily or to placebo treatment twice daily. The primary efficacy variables were the rate of complete healing of all necrosis and ulceration 12 weeks after the end of treatment and the frequency of major amputations 24 weeks after the end of treatment. Results A total of 840 patients were randomised between 2004 and 2013. At baseline, no major differences between treatment groups were found. The rate of “complete healing” was 18.4% in patients on alprostadil and 17.2% in patients on placebo. The rates of “major amputations” were 12.6% in patients on alprostadil and 14.6% in patients on placebo. The adjusted difference between alprostadil and placebo including their 95% confidence intervals was 1.1 (−4.0 to 6.3) for “complete healing” and −2.1 (−6.7 to 2.5) for “major amputations.” In the subgroup of diabetic patients the rates of major amputations were numerically lower in the alprostadil than placebo group (10.6% vs. 17.4%). Within the total cohort a non-significant difference in “decrease in ulcer area ≥50%” was reached in 30.2% of patients on alprostadil and in 24.3% of patients on placebo at end of treatment. Conclusions In this study, superiority of alprostadil over placebo could not be shown. Nevertheless, a slight numerical but not clinically relevant advantage for alprostadil emerged from the “area decrease of ulcers by ≥ 50%,” indicating that a healing effect may have started. The results have to be considered in the light of several limitations in study design and conduct. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objectives 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. Methods 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. Results 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. Conclusions 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. [ABSTRACT FROM AUTHOR]

Objectives Although commonly used to measure health related quality of life in patients with lower limb ischaemia, the measurement properties of the VascuQol and its assumed underlying health dimensions have not been studied in depth. The objective of this study was therefore to evaluate aspects of reliability and validity of the Dutch version of the VascuQol in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). Methods Two datasets containing 195 patients with IC and 150 patients with CLI were used. Face validity of the VascuQol was examined in interviews with patients and a survey among health professionals. Homogeneity and structural validity of the VascuQol were assessed using Cronbach's α coefficients and explanatory factor analysis. Furthermore, convergent validity and known group validity were assessed. Results During the face validity interviews, three items were indicated as less relevant. Homogeneity analysis showed that the α coefficient of the VascuQol was .93, while the symptoms and social domains had α coefficients below the threshold of .70. The original five domains of the VascuQol could not be reproduced. Instead, factor analysis yielded a three factor solution. Moderate correlations were found for the activities, social and emotional VascuQol domains and matching health domains of other patient reported outcome measures (PROMs). Lower convergent correlations were observed for the pain domain and the sumscore of the VascuQol. The VascuQol was able to distinguish between patients' level of HRQL in relation to their disease severity (IC versus CLI patients). Conclusions There is room for improvement of the VascuQol questionnaire. Further clinimetric studies should be performed to strengthen clinically relevant findings based on this instrument. [ABSTRACT FROM AUTHOR]

Introduction As the population ages and the incidence of diabetes increases, the expected number of patients with critical limb ischaemia (CLI) requiring distal revascularization will remain high or even increase. The aim of this study was to investigate the long-term results of inframalleolar bypass. Material and methods A total of 352 inframalleolar bypasses for CLI performed between 2002 and 2013 were included. Risk factors were evaluated and patency (both clinical and imaging based), leg salvage, survival, and amputation free survival (AFS) assessed. Results The median follow up was 30 months (mean 42 months, range 1–186 months). The median age of the study population was 73 years, and 67% of the patients were male. The incidence of diabetes was 69%. In the majority of cases (82%), the indication for bypass was an ulcer or gangrene, and the remaining 18% of the patients had rest pain. Primary, assisted primary, and secondary clinical patency was 71.2%, 76.5%, 81.0%, and 59.7%, 69.3%, and 70.7%, and 49.0%, 58.6%, and 68.4% at 1, 5, and 10 years, respectively. The last imaging based secondary patency at 1, 5, and 10 years was 79.3%, 68.1%, and 62.8%, respectively. The popliteal artery as the inflow artery ( n = 194) was associated with superior primary ( p = .013), assisted primary ( p = .028), and secondary patency ( p = .014) when compared with bypasses originating from the femoral artery ( n = 158). The leg salvage rate at 1, 5, and 10 years was 78.6%, 72.0%, and 67.2%, respectively. Leg salvage was equal in patients with and without diabetes ( p = .460). The respective survival and AFS rates at 1, 5, and 10 years were 70.3%, 37.4%, and 15.9%, and 58.4%, 29.8%, and 12.8%. Conclusion Bypass to the foot arteries yielded excellent long-term patency, and good limb salvage can be achieved in both non-diabetic and diabetic patients. [ABSTRACT FROM AUTHOR]

Objectives It is difficult to establish which patients suffering from critical lower limb ischaemia will benefit from revascularization. Risk scores can provide objectivity in decision making. The aim was to design a new risk score (ERICVA) and compare its predictive power with the PREVENT III and Finnvasc scores. Methods An observational retrospective study of patients who underwent revascularization (open or endovascular) in Valladolid's University Hospital between 2005 and 2010 was designed. The sample was divided into two subgroups (development and validation subsamples). After univariate analysis followed by a multivariate Cox regression, a number of variables associated with death and/or major amputation were selected, creating a weighed score called ERICVA, and a simplified version of it. The area under the curve (AUC) of receiver operating characteristic (ROC) curve analysis was performed and the AUC of these two scores were additionally compared with the AUC of the PREVENT III and Finnvasc scales. Results Six hundred and seventy two cases with an average surveillance of 778 days were included in the study. Amputation free survival (AFS) was 84.8% at 30 days and 63.1% at 1 year. Variables associated with death and/or major amputation in the Cox regression were cerebrovascular disease, prior contralateral major amputation, diabetes mellitus, dialysis, chronic obstructive pulmonary disease, cancer, haematocrit less than 30%, neutrophil/lymphocyte ratio exceeding 5, absence of arterial Doppler signal at the ankle, emergency admission, and Rutherford stage 6; these variables were used for the ERICVA and simplified ERICVA score designs. Scores were applied to both subsamples; in the development sample the AUC of ERICVA and simplified ERICVA was significantly higher than the PREVENT III ( p = .008 and p = .045) and Finnvasc ( p < .0001 and p = .0013) scores; in the validation sample the AUC of ERICVA and simplified ERICVA were significantly higher than Finnvasc score ( p = .0323 and p = .0017). Conclusions The ERICVA model has a good predictive capacity for death and/or major amputation in the clinical setting, and is better than the PREVENT III and Finnvasc scores. [ABSTRACT FROM AUTHOR]

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. [Copyright &y& Elsevier]

Objectives: Endovascular treatment for peripheral arterial disease (PAD) is increasingly used and also continuously applied to more severe vascular pathology. Only few studies report on systemic complications during these procedures, but it is important to address these risks. We report the results of a recent national audit on cardio- and cerebrovascular complications after endovascular procedures for PAD. Methods: Data from the Swedish Vascular Registry (Swedvasc) were retrieved on all infrainguinal endovascular procedures performed between May 2008 and December 2011. A total of 9187 cases were analysed regarding the prevalence of myocardial infarction and major stroke within 30 days post-intervention. A literature review in PubMed and Cochrane databases was conducted. Results: The risk of myocardial infarction was 0.3% in intermittent claudication, 1.2% in critical limb ischaemia and 1% in acute limb ischaemia. Corresponding risk of major stroke was 0.4%, 0.3% and 1.4%. Thrombolytic therapy was associated with a threefold risk of major stroke. Only a few studies relevant to the subject were found during the literature review. Conclusions: In this population-based study we found a low risk of cardiac complications, but catheter-administered thrombolytic therapy entailed a non-negligible risk of major stroke. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Long occlusions in calcified crural arteries are a major cause of endovascular technical failure in patients with critical limb ischaemia. Therefore, distal bypasses are mainly performed in patients with heavily calcified arteries and with consequently delicate clamping. A new reverse thermosensitive polymer (RTP) is an alternative option to occlude target vessels. The aim of the study is to report our technical experience with RTP and to assess its safety and efficiency to temporarily occlude small calcified arteries during anastomosis time. Methods: Between July 2010 and December 2011, we used RTP to occlude crural arteries in 20 consecutive patients with 20 venous distal bypasses. We recorded several operative parameters, such as volume of injected RTP, duration of occlusion and anastomotic time. Quality of occlusion was subjectively evaluated. Routine on-table angiography was performed to search for plug emboli. Primary patency, limb salvage and survival rates were reported at 6 months. Results: In all patients, crural artery occlusion was achieved with the RTP without the use of an adjunct occlusion device. Mean volume of RTP used was 0.3 ml proximally and 0.25 ml distally. Mean duration of occlusion was 14.4 ± 4.5 min, while completion of the distal anastomosis lasted 13.4 ± 4.3 min. Quality of occlusion was judged as excellent in eight cases and good in 12 cases. Residual plugs were observed in two patients and removed with an embolectomy catheter, before we amended the technique for dissolution of RTP. At 6 months, primary patency rate was 75% but limb salvage rate was 87.5%. The 30-day mortality rate was 10%. Conclusions: This study shows that RTP is safe when properly dissolved and effective to occlude small calcified arteries for completion of distal anastomosis. [Copyright &y& Elsevier]

Abstract: 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. [Copyright &y& Elsevier]

Abstract: 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. [Copyright &y& Elsevier]

Abstract: Objectives: To compare practice in lower limb bypass surgery in nine countries. Design: A prospective study amalgamating and analysing data from national and regional vascular registries. Methods: A table of data fields and definitions was agreed by all member countries of the Vascunet Collaboration. Data from January 2005 to December 2009 was submitted to a central database. Results: 32,084 cases of infrainguinal bypass (IIB) in nine countries were analysed. Procedures per 100,000 population varied between 2.3 in the UK and 24.6 in Finland. The proportion of women varied from 25% to 43.5%. The median age for all countries was 70 for men and 76 for women. Hungary treated the youngest patients. IIB was performed for claudication for between 15.7% and 40.8% of all procedures. Vein grafts were used in patients operated on for claudication (52.9%), for rest pain (66.7%) and tissue loss (74.1%). Italy had the highest use of synthetic grafts. Among claudicants 45% of bypasses were performed to the below knee popliteal artery or more distally. Graft patency at 30 days varied between 86% and 99%. Conclusions: Significant variations in practice between countries were demonstrated. These results should be interpreted alongside the known limitations of such registry data with respect to quality and completeness of the data. Variation in data completeness and data validation between countries needs to be improved for useful international comparison of outcomes. [Copyright &y& Elsevier]

Abstract: Objectives: The concept of patency and limb salvage are physician-oriented endpoints in critical limb ischaemia (CLI). These endpoints have failed to enhance function after revascularisation. The aim of this study was to create a scoring system to predict 1-year functional status and to assess the benefit to patients possible by revascularisation. Materials and methods: During the period 2007–2009, 480 consecutive patients (mean age ± SD, 83.2 ± 8.7 years) underwent repair for CLI. Preoperative, operative and functional status characteristics and post-operative outcomes were recorded. The following patient-oriented outcomes were investigated pre- and postoperatively: basic and instrumental activities of daily living (BADL and IADL) and ambulatory and living status. Statistical analysis was performed to assess predictors of functional benefit from revascularisation. The variables significant on multivariable analysis were used to generate a scoring system to pre and postoperatively grade individual patient risk of losing baseline functional status at 1 year (CLI functional score). Results: Ninety-three of 480 patients (19.3%) were in Rutherford class IV, 208 (43.3%) in class V and 179 (37.4%) in class VI. Surgical, endovascular and hybrid operations were performed in 108 (22.5%), 319 (66.5%) and 53 (11%) patients, respectively; mean follow-up was 408 ± 363 days. Improved or unchanged functional status was observed in 276 patients (57.5%). Preoperative mean ± SD BADL and IADL (4.26 ± 1.98 and 3.92 ± 2.69, respectively) were modified from mean values at 1-year follow-up (4.19 ± 2.06 and 4.12 ± 3, respectively) (p = 0.401 and p < 0.05, respectively). In the same time interval, mortality was 50%, limb salvage 50.4%, CLI-related new hospitalisations 50.8%, relief of symptoms 18.5% and tissue healing 14.5%. A CLI functional score of >80% indicates that patients are likely to lose functional abilities and require assistance for ambulation or ADL, as well as risking outcomes such as major amputation, new CLI-related hospitalisation or re-operation (p < 0.001). Preoperative poor living status, dependence in daily activities, advanced local disease (lesion >2 cm, infection and poor tibial runoff), American Society of Anesthesiologists (ASA) score > II, previous cerebrovascular event and heart disease were the strongest pre-operative negative predictors of losing baseline functional status. Major amputation was the only negative post-operative predictor. Conclusions: Considering patient-oriented outcomes, our study showed that revascularisation could be worthwhile in nearly 60% of CLI patients. A non-revascularisation strategy such as primary amputation or palliation could be indicated in patients with a poor pre-operative living status, dependence for daily activities, advanced local disease, extensive comorbid conditions and a score >80%. To make our findings generalisable, the score needs to be validated in independent cohorts at different centres before it can be recommended for application. [Copyright &y& Elsevier]

Abstract: 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. [Copyright &y& Elsevier]

Abstract: Objectives: To 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. Design: Retrospective multicenter study. Materials and methods: Between 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. Results: Patient 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 <18, non-ambulatory status and ejection fraction <45%. Two-year limb salvage rate was 80 ± 2%. Factors associated with major amputation were ulcers (Rutherford 6), diabetes mellitus, C-reactive protein>5 mg/dL, and age < 60 years. Two-year freedom from re-intervention was 66 ± 3%; age and below-the-ankle runoff number after angioplasty was negatively associated with re-intervention. Conclusions: Despite relatively high mortality and re-intervention rates, limb salvage rate was acceptable after EVT for CLI patients with isolated BTK lesions. Risk stratification allows occurrence estimation for each end point. [Copyright &y& Elsevier]

Abstract: Objectives: The aim of the study is to determine factors affecting ischaemic wound healing and role of the angiosome concept in bypass surgery. Design: Single-centre, retrospective clinical study. Materials and methods: A total of 249 consecutive critical ischaemic limbs with tissue loss in 228 patients who underwent distal bypasses from 2003 to 2009 were reviewed. A total of 81% of patients were diabetic, and 49% of patients had dialysis-dependent renal disease (end-stage renal disease, ESRD). Distal targets of bypasses were the crural artery (57%) and the pedal artery (43%). Results: The complete healing of ischaemic wounds was achieved in 211 limbs (84.7%). ESRD (odds ratio (OR) 0.127, p < 0.001), diabetes (OR 0.216, p = 0.030), Rutherford category 6 (R6) with heel ulcer/gangrene (OR 0.134, p < 0.001), R6 except heel (OR 0.336, p = 0.025) and low albuminaemia (OR 0.387, p = 0.049) were negative predictors of wound healing. Regarding the angiosome, the healing rate in the indirect revascularisation (IR) group was slower than in the direct revascularisation (DR) group, especially in patients with ESRD (p < 0.001). However, the healing rates of the DR and IR groups were similar after minimising background differences with propensity score methods (p = 0.185). Conclusions: In the field of bypass surgery, the angiosome concept seems unimportant, at least in non-ESRD cases. The location and extent of ischaemic wounds as well as co-morbidities may be more relevant than the angiosome in terms of wound healing. [Copyright &y& Elsevier]

Abstract: 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 < 0.001). 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. [Copyright &y& Elsevier]

Abstract: Objective: Patient- and society-oriented measures of outcome have a critical role in determining the effectiveness of any treatment in patients with critical limb ischaemia (CLI). In particular, the impact of an intervention on patient’s dependency and functional performance is relevant but is largely unknown. The aim of the study was to investigate whether the limitations encountered in the activities of daily living (ADLs) measured with the Katz Index (KI) in patients with CLI were changed by the treatment. Methods: During the period 2006–2008, 248 consecutive patients undergoing repair for CLI were investigated with an ADL questionnaire for assessing KI before and after a mean of 16.19 months from treatment. Changes in KI were stratified by type of treatment and outcome. Results: There were 165 males and 83 females, mean age 73.3 ± 8.3 years; 125 patients showed tissue loss and 123 rest pain alone, 98 received surgical bypass and 150 endovascular repair. Pre-operative KI mean was 10.42. At the post-operative assessment, there was significant worsening in patients’ functional outcome (mean KI decreased to 9.78) despite relief of pain (81.5%), tissue healing (72%), good vessel patency (83.8%) and low amputation rate (9.7%). Deterioration of KI was not significantly higher in patients undergoing endovascular repair. Patients receiving major amputation started with worse pre-operative functional score (KI mean 9.42) and did further deteriorate (KI mean 7.71) after demolition surgery. However, patients who received successful revascularisation showed deterioration in the dependence index. Conclusions: Successful vascular treatment is not associated with improved functional ability in patients with CLI, especially when already highly dependent in their activities. Large nationwide preventive and educational programmes should be implemented to prevent irreversible and severe health deterioration in populations with CLI. [Copyright &y& Elsevier]

Abstract: Objective: To report our experience of long-term results of inframalleolar bypass. Design: Retrospective analysis. Materials and methods: We analysed 122 inframalleolar bypasses performed between January 1991 and June 2005 in 116 patients. Most patients were treated for critical ischaemia (97%). The indication for the use of podalic arteries was a lack of tibial arteries with run-off to the foot. The dorsalis pedis was predominantly used for distal anastomoses (62.3%) and the greater saphenous vein (84.4%) as the conduit. The follow-up periods ranged from 1 to 60 months. The endpoints analysed were graft patency, limb salvage, preservation of deambulation and survival rate. Results: The cumulative patency was 58.2% at 3 years and 53.4% at 5 years. The best results were achieved with the devalvulated greater saphenous veins. Limb salvage was 70.0% at 3 years and 50.4% at 5 years, with preserved deambulation rates of 57.3% and 47.1%, respectively. There were 36 major and 45 minor amputations. At 3 years, the survival rate was 50.2% and the surgical mortality 13%. Female sex was associated with worse results for cumulative patency and limb salvage (P <0.01). Conclusions: In the long term, inframalleolar bypass is a satisfactory option for limb salvage. [ABSTRACT FROM AUTHOR]

Abstract: Background: Patency and limb salvage after synthetic bypass to the arteries below-knee are inferior to that which can be achieved with autologous vein. Use of a vein collar at the distal anastomosis has been suggested to improve patency and limb salvage, a problem that is analysed in this randomised clinical study. Methods: Patients with critical limb ischaemia undergoing polytetrafluoroethylene (PTFE) bypass to below-knee arteries were randomly either assigned a vein collar or not in two groups – bypass to the popliteal artery below-knee (femoro-popliteal below-knee (FemPopBK)) and more distal bypass (femoro-distal bypass (FemDist)). Follow-up was scheduled until amputation, death or at most 5 years, whichever event occurred first. Results: In the FemPopBK and in the FemDist groups, 115/202 and 72/150 were randomised to have a vein collar, respectively. Information was available for 345 of 352 randomised patients (98%). At 3 years, primary patency was 26% (95% confidence interval (CI) 18–38) with a vein collar and 43 (33–58) without a vein collar for femoro-popliteal bypass and 20 (11–38), and 17 (9–33) for femoro-distal bypass, respectively. The corresponding figures for limb salvage were 64 (54–75) and 61 (50–74) for femoro-popliteal bypass, and 59 (46–76) and 44 (32–61) for femoro-distal bypass with and without a vein collar, respectively. Log-rank-test for the whole Kaplan–Meier life table curve showed no statistically significant differences with or without vein collar primary patency: p = 0.0853, p = 0.228; secondary patency: p = 0.317, p = 0.280; limb salvage: p = 0.757, p = 0.187 for FemPopBK and FemDist, respectively. The use of a vein collar did not influence patency or limb salvage. Conclusion: This study failed to show any benefit for vein collar with PTFE bypass to a below-knee artery. [Copyright &y& Elsevier]

Abstract: Aim: Occlusion or severe stenosis of pedal and plantar arteries limits surgical options for critical limb ischaemia (CLI). Below-the-ankle (BTA) angioplasty is potentially useful as an adjunct to proximal angioplasty. In this study, the feasibility and outcome of this procedure were explored, as they have not been evaluated previously. Methods: Patients'' demographics, indications, procedures and outcomes were recorded. Outcomes were determined by technical success, primary patency, limb salvage and amputation-free survival (AFS) rates. Results: Between 2004 and 2008, 42 cases of BTA angioplasty were performed for 39 patients. Forty cases (95.2%) had CLI. Technical success was achieved in 88% of cases. At 6, 12 and 24 months, AFS was 70.7%, 60.9% and 57.1%, limb salvage was 84.9%, 81.9% and 81.9% and patient survival was 83.3%, 73.8% and 67.3, respectively. Seven major amputations (16.6%) were performed, four of which had failed angioplasty. Two patients required re-intervention. Univariate analysis showed insulin-dependent diabetics, occlusive lesions, failure of angioplasty and state of the run off to be the predictors of limb loss. Conclusions: BTA angioplasty for pedal and plantar arterial occlusive disease is technically feasible. It has good medium-term clinical outcome and limb salvage in a group of patients with poor surgical options. [Copyright &y& Elsevier]

Abstract: Background: To evaluate the therapeutic value of endovascular techniques for the treatment of profunda femoris artery obstructive disease (PFAOD) in critical limb ischaemia (CLI) patients, with technically demanding open profunda repair. Design: Retrospective study of prospectively collected data of 15 consecutive CLI patients with technically demanding surgical treatment of PFAOD, that were treated by endovascular means in two European Centers of Vascular Surgery. Materials: All patients had critical limb ischaemia with a history of at least two previous vascular reconstructions in the ipsilateral groin and severe co-morbid conditions. All patients had good common femoral artery flow, long occlusion of the superficial femoral and popliteal arteries and impairment of crural arteries. Methods: Twelve patients underwent balloon angioplasty alone and, in the other three cases, an additional stent placement was necessary, due to flow-limiting dissection. The follow-up (mean 29.2±10 months) included a surveillance protocol with the best medical treatment and duplex scanning at 1, 3, 6, 12 months and yearly thereafter. Results: The endovascular approach was technically successful in all cases and the procedure-related morbidity and mortality rates were 0% for the entire follow-up period. The 3-year primary and secondary patency rates of the treated segment were 80% and 86.7%, respectively. The limb salvage rate was 93.3%. Conclusions: The outcome of our series underscores the therapeutic value of balloon angioplasty in cases of severe PFAOD, as bailout treatment in critical limb ischaemia patients with technically demanding open profunda repair. This procedure can be repeated easily if significant restenosis occurs and provides a useful tool in selected cases. [Copyright &y& Elsevier]

Abstract: This prospective study aims to evaluate the impact of the excimer laser technology as the first-line endovascular treatment of critical limb ischaemia (CLI) in diabetic patients. The protocol allowed the use of laser ablation of obstructive lesions when conventional endoluminal guidewire crossing of the plaque was unsuccessful. We extrapolate the data of consecutive patients treated, who completed at least 12 months of follow-up, extending the observation to a 26-month time frame. During this period, 67 diabetic patients with CLI were brought to the Cath Lab for ‘operative angioplasty’ and to be treated with endovascular techniques. Of the 67 cases, laser was used on 35 patients to treat 51 lesions. All patients had type C or D occlusive lesions, according to the TACS II classification, showing a single type D plaque or multiple tandem C/D occlusive plaques ranging from 4 to 23cm in length. The immediate clinical success, defined as restored direct arterial flow to the foot, was 88.2%. The lesions were successfully crossed by laser in 45 out of 51 attempts. Stents were required in 25% of the patients with 21% lesions. Patency rates were assessed using the Kaplan–Meier survival curves. The patency rates of the successfully treated lesions (freedom from target lesion revascularisation) were 96.6% at 12 months and 82.7% at 24 months. Limb-salvage rate at 12 and 24 months were 100% and 94%, respectively. Our study showed that the excimer laser-assisted angioplasty, when feasible, is effective in granting event-free survival in CLI patients with diabetes, and that endoluminal-driven atherectomy allows long-term success in reducing the need of stents in the lower limb arteries. [Copyright &y& Elsevier]

Abstract: Objectives: To evaluate the results and complications of combined simultaneous arterial re-vascularisation and free flap transfer in patients with critical limb ischaemia and large soft-tissue defects that would otherwise have required major amputation. Design: Retrospective analysis of all combined procedures performed between 1993 and 2007 with regard to complications and outcome. Materials and methods: Seventy-eight procedures were performed in 76 patients with a mean age of 60 years (range: 18–80 years). The majority had diabetes (70.5%). Follow-up was obtained from hospital charts and telephone contacts with patients or GPs. Results: The limb-salvage rate was 93% after 1 year, 80% after 3 years and 71% after 5 years. Perioperative complications occurred in 50% of the patients; six out of 78 (7.7%) arterial reconstructions and 13 out of 78 (16.7%) flaps had to be revised during the early postoperative period. However, most flaps could be saved by a secondary procedure resulting in an early failure (amputation) rate of 6%. In-hospital mortality was 3.8%. End-stage renal disease was the only factor predicting limb loss. In total, 65% of the patients survived and were able to walk on their reconstructed limb at 1-year follow-up. Combined survival and limb-salvage rates were 85%, 66% and 51% after 1, 3 and 5 years. Conclusions: Combined arterial re-vascularisation and free flap transfer can be performed safely with acceptable morbidity and mortality and should be considered for every mobile patient with large soft-tissue deficit (>10cm2) without end-stage renal disease prior to major amputation. [Copyright &y& Elsevier]

Abstract: Aim: The aim of this prospective study was to assess the clinical effectiveness and related midterm patency of subintimal angioplasty (SAP) in patients suffering from critical limb ischaemia (CLI) in a single tertiary care university centre. The secondary aim was to evaluate the safety and clinical effectiveness of using a re-entry device when re-canalisation by SAP was unsuccessful. Methods: From January 2005 to December 2007, consecutive patients suffering from CLI (Rutherford clinical categories: 4–6) were treated with SAP. All patients included in the study had occluded SFA (TASC C and D) and underwent clinical and ultrasound follow-up examinations at day 30 and at 3, 6, 9 and 12 months, and then yearly. A re-entry device (Outback, Cordis Corporation, Miami Lakes, Florida, USA in all cases) was only used when re-canalisation by simple SAP was unsuccessful, and stenting was used when residual stenosis was >30% or there was a flow-limiting dissection. Factors that could modify the outcome were analysed. Results: In this study, 145 patients were treated, with a technical success rate of 83.5% (121 of 145) for simple SAP. Stenting was performed in 43% (n =62) of successful SAP procedures. No death occurred in the perioperative period, while the 30-day mortality was 4.8% (7 of 145). The re-entry device (Outback) was used in 24 cases (16.5%). The technical success of the re-entry device was 79% (19 of 24), with a 90% success rate of stent placement at the site of re-entry. Complications occurred in 6.2% of all procedures (n =9) (three arterial perforations (2.1%), three distal embolisations (2.1%), two femoral artery pseudo-aneurysms (1.4%) and one arterio-venous fistula (0.7%)). Factors capable of independently affecting the patency were renal insufficiency (p =0.03), current smoking (p =0.01) and diabetes (p =0.04). The primary patency at 1 and 3 years was 70% and 34% and the secondary patency at 1 and 3 years was 77% and 43%, respectively. At the same time intervals, the limb-salvage rate was 88% and 49%. Conclusions: SAP with the aid of a re-entry device for TASC C and D lesions of the SFA seems to be safe and clinically effective in patients suffering from CLI, according to the experience at our centre. Further follow-up and more data are necessary to confirm these findings. [Copyright &y& Elsevier]

Abstract: Purpose: To evaluate the effectiveness of nitinol stent placement in long infrapopliteal lesions in patients with critical limb ischaemia. Materials and methods: Between January 2005 and January 2008, 34 high-risk patients (18 female; mean age: 73.8±6.1 years) with critical limb ischaemia underwent infragenicular stenting. They had serious cardiovascular co-morbidities (>3, such as chronic obstructive pulmonary disease (COPD), congestive heart failure and coronary artery occlusive disease), American Society of Anaesthesiologists score of 3 or more, previous myocardial infarction, coronary stent or bypass. The mean stenosis length was 6.5±0.9cm (range: 2.2–8cm), and the mean occlusion length was 7.5±2.9cm (range: 3–9.6cm). Primary stent implantation was performed for long stenosis or occlusion based on the TransAtlantic InterSociety Consensus (TASC) C and D classification, secondary stenting for flow-limiting dissections or elastic recoil after balloon dilatation. All patients who returned to the outpatient clinic were assessed for claudication by clinical examination, ankle–brachial index (ABI) measurements, colour flow and duplex Doppler ultrasound (US). Digital subtraction angiography was performed if restenosis or re-occlusion was identified by Doppler US or transcutaneous measurement of partial oxygen pressure (TcpO2) measurements, when appropriate. Results: The technical success rate was 97.1% (33 of 34 cases). The crude rate of primary patency rate was 91.1% during a follow-up period of 10.4±7.3 months. The mean ankle–brachial index increased significantly following intervention (0.45±0.25–0.92±0.13, p <0.001). Two patients underwent successful redo angioplasty after tibioperoneal interventions due to in-stent restenosis (>70%) with relevant limitation of pain-free walking distance. In another patient, bypass surgery to the anterior tibial artery 6 months after primary intervention was necessary due to rest pain. Two patients required surgical revision of the femoral artery after antegrade access. No procedure-related death was recorded in the entire follow-up period. Conclusions: The mid-term outcome underscores infrapopliteal stent placement as a reliable treatment option in patients with critical limb ischaemia. In patients at high risk for crural bypass, with no flow-limiting supragenicular lesions, below-knee stent-supported angioplasty should be considered as a first choice of treatment. [Copyright &y& Elsevier]

Abstract: Objectives: To assess health-related quality of life (HRQoL) up to 24 months after successful infrageniculate bypass surgery for limb-threatening ischaemia. Methods: 89 patients with infrageniculate bypass surgery for limb-salvage were studied. HRQoL was assessed using the Short Form (SF)-36v1 questionnaire before, 6, 12, and 24 months after revascularisation. Results: 47 patients (53%) with intact limb and functioning graft were assessed after 24 months, 27 patients (30%) died, further 7 required secondary amputation, 3 suffered irremediable graft occlusion, and 4 were lost to follow-up. The 24-months HRQoL-values were significantly improved in 4 domains: physical functioning (p <0.01), bodily pain (p <0.01), mental health (p =0.04), and social functioning (p =0.01). Except for baseline-values, HRQoL remained inferior in diabetics compared to non-diabetics throughout follow-up. Maximum improvement of HRQoL was delayed in diabetics (12 months vs. 6 months) and less pronounced. After 24 months non-diabetic patients maintained improvement in 5 domains and diabetic patients only in bodily pain. Conclusions: Improvement in HRQoL is sustained for more than 12 months after successful infrageniculate bypass surgery. Therefore, an aggressive approach towards revascularisation seems to be justified from the patient''s perspective. However, this benefit in quality of life is less in diabetic patients, despite similar limb-salvage rates. [Copyright &y& Elsevier]

Objectives: Cardiovascular mortality in patients with chronic critical lower limb ischaemia (CCLI) is high and early risk stratification in these patients may aid clinical management improving outcomes. Cardiac troponin I (cTnI) has prognostic significance in patients with unstable angina. The aim of this study was to evaluate the prognostic significance of cardiac troponins in CCLI patients who had no clinical evidence of unstable coronary heart disease. Methods: Patients (n =152) admitted with CCLI to a single vascular unit over a two-year period were included prospectively in this study. Patients with clinical evidence of unstable coronary disease were excluded from the study. Patient demographics, clinical history, co-morbidity and risk factors for peripheral vascular disease were documented. Admission cTnI levels were recorded using a threshold, 0.1ng/ml. The primary endpoint was mortality. Results: Fifty-two patients (34.2%) had an elevated cTnI, whilst 100 (65.8%) had cTnI <0.1ng/ml. Sixty-two patients died during the follow-up period, 38 with an elevated admission cTnI. Death rate in patients with cTnI >0.1ng/nl was 73% compared with 24% in those with levels below the threshold (p <0.0001). Patients with elevated cTnI were significantly older than those with normal level (median age 76 years vs 71 years, p <0.001). An elevated cTnI was found to independently predict disease-specific mortality on Cox regression analysis (Hazard Ratio 4.2; 95% Confidence Interval 1.3–12.7). Conclusion: In this series of patients with CCLI the measurement of cTnI on admission was a significant independent predictor of survival. cTnI has potential as a prognostic test to stratify patients with a high cardiovascular risk and may enable further optimisation of these high-risk patients. [Copyright &y& Elsevier]

Objectives: To evaluate the feasibility and the mid-term results of subintimal angioplasty (SA) in the treatment of critical limb ischaemia (CLI) with tibial vessels occlusions. Materials and methods: Between August 2000 and March 2005, we attempted to treat 46 patients (23 men, 23 women, median age of 75 years; range 35–92) and 50 limbs by SA of occluded tibial vessels. Twenty-one had gangrene, 25 ulcerations and 4 had rest pain. Thirty-nine occlusions (78%) were more than 10cm in length, 28 (56%) involved popliteal and tibial artery and distal re-entry was at the ankle level in 18 cases (36%). Twenty-eight patients (61%) were diabetics. Results: There were nine technical failures. Five of these patients were successfully treated medically (1), by conventional surgery (1) or by conventional angioplasty of another diseased tibial vessel (3). The four remaining patients had major amputation and 3 died within 3 months. There were 7 complications including 2 embolisms, 1 perforation and 4 haematomas. By intention to treat, one-year primary, secondary and clinical patency rates were 46%, 55% and 63%, respectively. One and two-year limb salvage rates were 87%. One and two-year survival rates were 74% and 64%, respectively. Conclusions: SA of tibial vessel occlusions is a valuable treatment of CLI. Technical failures do not preclude conventional surgery when there is a valuable outflow. Complications may often be treated medically or by endovascular procedures. Results have to be confirmed by long-term follow up. Both techniques should be considered as complementary techniques in the management of CLI. [Copyright &y& Elsevier]

Objective: To review the best medical management of critical limb ischaemia (CLI). Methods: Published studies dealing with CLI and risk factors were searched for via PUBMED. Findings and conclusions: Patients with critical limb ischaemia (CLI) have a one and ten year mortality of approximately 20% and 75% respectively. Risk factors for the development of peripheral atherosclerosis are the same as for coronary and cerebrovascular atherosclerosis namely diabetes mellitus, hyperlipidaemia, arterial hypertension, and smoking. As there are few studies of risk factor for peripheral arterial occlusive disease (PAOD), treatment recommendations are often based on studies in patients with coronary or cerebrovascular atherosclerosis. While waiting for specific studies, CLI patients should be treated according to current guidelines for other atherosclerotic patients. [Copyright &y& Elsevier]

Abstract: Objectives: The aim of the study was to assess the change in health related quality of life (HRQoL) after infrageniculate bypass grafting in patients with critical limb ischaemia (CLI). Design: Observational, prospective clinical study. Materials and methods: In total, 86 patients (72% male; age 71 (IQR, 64–78) years) undergoing infrageniculate bypass grafting for limb salvage were assessed by the short form (SF)-36 questionnaire before and 6 months after surgery. In subgroup analysis, the influence of diabetes mellitus, age, gender, and stage of peripheral arterial occlusive disease on HRQoL-outcome were assessed. Results: Following revascularization HRQoL significantly improved in all eight dimensions of the SF-36. While baseline HRQoL-values of diabetic and non-diabetic patients did not differ significantly, postoperative improvement was significantly less in the diabetes group. Conclusions: An aggressive approach towards infrageniculate bypass surgery for limb salvage is justified by quality of life improvement. However, this improvement tends to be less in patients with diabetes mellitus. [Copyright &y& Elsevier]