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This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest. The study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan–Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n = 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n = 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n = 2 278). The mean age of patients was 72.3 (SD = 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 – 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 – 1.04) and cohort C (HR 1.10, 95% CI 0.84 – 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 – 1.00; cohort B: HR 0.84, 95% CI 0.67 – 1.06; and cohort C: HR 1.05, 95% CI 0.51 – 2.14). No increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings. [ABSTRACT FROM AUTHOR]

Equal access for equal needs is a key goal for many healthcare systems but geographical variation research has shown that this is often not the case in areas other than vascular surgery. This study assessed the variation across specialised vascular centres of an entire healthcare system in the costs and outcomes for patients having first time revascularisation for peripheral arterial occlusive disease. This was a national study of all first time revascularisations performed in the Danish healthcare system between 2009 and 2014. Episodes were identified in the Danish Vascular Registry (n = 10 300) and data on one year follow up in terms of the costs of specialised healthcare (€) and amputation status were acquired from national registers. Generalised gamma and logit regressions were used to predict margins between centres while adjusting for population heterogeneity (age, sex, education, smoking, hypertension, diabetes, use of prophylactic pharmacological therapy, indication and type of revascularisation). Cost effectiveness frontiers were used to identify efficient providers and to illustrate the cost of reducing the system level risk of amputation. For each of the indications of chronic limb threatening and acute limb ischaemia, the one year amputation risks varied from 11% to 16% across centres (p =.003, p =.006) whereas for intermittent claudication there was no significant difference across centres. The corresponding costs of care varied across centres for all indications (p =.027, p =.028, p =.030). Linking costs and outcomes, three of seven centres were observed to provide poorer quality at higher costs. Exponentially increasing costs to obtain the maximum reduction of the amputation risk were observed. The results suggest that there is substantial variation in the clinical management of peripheral arterial occlusive disease across the Danish healthcare system and that this results in very different levels of efficiency – on top of potentially unequal treatment for equal needs. Further research is warranted. [ABSTRACT FROM AUTHOR]

The AMBUVASC trial evaluated the cost effectiveness of outpatient vs. inpatient hospitalisation for endovascular repair of lower extremity arterial disease (LEAD). AMBUVASC was a national multicentre, prospective, randomised controlled trial conducted in nine public and two private French centres. The primary endpoint was the incremental cost effectiveness ratio (ICER), defined by cost per quality adjusted life year (QALY). Analysis was conducted from a societal perspective, excluding indirect costs, and considering a one month time horizon. From 16 February 2016 to 29 May 2017, 160 patients were randomised (80 per group). A modified intention to treat analysis was performed with 153 patients (outpatient hospitalisation: n = 76; inpatient hospitalisation: n = 77). The patients mainly presented intermittent claudication (outpatient arm: 97%; inpatient arm: 92%). Rates of peri-operative complications were 20% (15 events) and 18% (14 events) for the outpatient and inpatient arms respectively (p =.81). Overall costs (difference: €187.83; 95% confidence interval [CI] −275.68–651.34) and QALYs (difference: 0.00277; 95% CI –0.00237 – 0.00791) were higher for outpatients due to more re-admissions than the inpatient arm. The mean ICER was €67 741 per QALY gained for the base case analysis with missing data imputed using multiple imputation by predictive mean matching. The outpatient procedure was not cost effective for a willingness to pay of €50 000 per QALY and the probability of being cost effective was only 59% for a €100 000/QALY threshold. Outpatient hospitalisation is not cost effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a €50 000/QALY threshold. [ABSTRACT FROM AUTHOR]

Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS). In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69–0.71) and CLTI (c statistic = 0.69, 95% CI 0.68–0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI. The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent. [ABSTRACT FROM AUTHOR]

Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan–Meier method and Cox regression. There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p <.001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78–0.91), amputation or death (HR 0.87, 95% CI 0.81–0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80–0.92) were observed. In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia. [ABSTRACT FROM AUTHOR]

Optimal pharmacological treatment (OPT) for peripheral arterial occlusive disease (PAOD) includes prescription of lipid lowering drugs, antithrombotics, and antihypertensives to symptomatic patients affected by intermittent claudication or chronic limb threatening ischaemia. This study sought to determine sex disparities and time trends in prescription of OPT in this population (clinicaltrials.gov NCT03909022). Using data from the second largest insurance fund in Germany, BARMER, data on patients with an index admission for symptomatic PAOD between 1 January 2010 and 30 June 2018 with follow up until the end of 2018 were analysed. Sex disparities in post-discharge prescription status six months after index admission were tested and adjusted for patient and healthcare variables using bivariable tests and logistic regression analysis. Time trends in the prescription prevalence of OPT were analysed and tested. There were 83 867 patients (mean age 71.9 years and 45.8% women) eligible for inclusion in the study. When compared with men, women had lower rates of prior outpatient care for PAOD (39.8% vs. 47.0%), were admitted more often with ischaemic rest pain (13.9% vs. 10.4%) and were older (74 vs. 70 y). After discharge, women had a lower rate of prescriptions for lipid lowering drugs (52.4% vs. 59.9%), while they received antihypertensive drugs more often (86.7% vs. 84.1%). We found evidence for a lower prescription prevalence of OPT in females (37.0% vs. 42.7%). Differences in patient and healthcare variables (e.g. demographics, comorbidities, prior treatment) between women and men explained 56% of this gap. The sex prescription gap did not narrow over time despite an overall upward trend in prescription prevalence for both women and men. Although presenting older and with more severe symptoms at the index admission for PAOD, women have a lower prescription prevalence of OPT compared with men, particularly with respect to lipid lowering drugs. [ABSTRACT FROM AUTHOR]

The aim of this study was to determine the survival of patients after use of paclitaxel coated devices (PCX), as a recent meta-analysis of randomised trials reported higher mortality in patients treated with PCX balloons and stents A retrospective health insurance claims analysis of patients covered by the second largest insurance fund in Germany, BARMER, was used to identify index femoropopliteal arterial interventions between 1 January 2010 and 31 December 2018. To ensure first PCX exposure, patients with prior deployment of PCX were excluded. The study cohort was stratified into patients with chronic limb threatening ischaemia (CLTI) and intermittent claudication (IC), then into balloons vs. stents cohorts. Within each stratum PCX were compared with uncoated devices. Propensity score matching was used to balance the study groups. Survival was evaluated using the Kaplan–Meier method and Cox regression. There were 37 914 patients (mean age 73.3 years; 48.8% female) included in the study. The annual proportion of PCX use increased from 3% to 39% during the study period for CLTI and from 4% to 48% for IC (both p <.001). Paclitaxel coated balloons and stents were associated with improved overall survival (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.77–0.90), amputation free survival (HR 0.85, 95% CI 0.78–0.91), and freedom from major cardiovascular events (HR 0.82, 95% CI 0.77–0.89) vs. uncoated devices at five years for CLTI. In IC cohort, mortality was significantly lower after using drug coated balloons (DCB) (HR 0.87, 95% CI 0.76–0.99) or combined DCB and drug eluting stents (HR 0.88, 95% CI 0.80–0.98). In this large health insurance claims analysis, rapid adoption of PCX, higher long term survival, better amputation free survival, and lower rates of major cardiovascular events were seen after their use for the treatment of CLTI. [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]

Objective/Background To describe the risk factor distribution and outcome for patients with critical limb ischemia (CLI) due to infrapopliteal arterial lesions treated by endovascular or open procedures, with special consideration of diabetic patients. Methods Data were collected from the Swedish Vascular Registry, Swedvasc, covering all procedures performed on 549 consecutive patients between May 2008 and January 2014 at the Karolinska University Hospital. Diagnosis of ischemic rest pain and/or tissue loss and treatment of infrapopliteal arterial occlusive disease were considered. Analysis was performed on the first procedure during the observation period, “endo” or “open”. Amputation rate and death from any cause were recorded as the primary outcome measures. Subgroup analysis was performed on diabetic patients. Results Patient demographics did not differ between the endo ( n = 430) and open ( n = 114) cohorts. Wound complications requiring treatment within 30 days were more common in patients treated with open procedures (32% vs. 1% for endo; p < .001), as well as stroke and myocardial infarction. Amputation rates were higher at 30 days in the open group (7% vs. 2%; p = .012) but similar at 1 year (10% vs. 7%; p = .206). Mortality was similar at 30 days ( p = .400) and 1 year ( p = .860). Median survival at the end of the observation period was 43 months for endo and 56 months for open patients ( p = .055). Patients with diabetes treated with open procedures had more complications at 30 days and a higher rate of transfemoral amputations at 1 year compared with non-diabetic patients. Conclusion This non-randomized registry based study shows similar outcomes regarding amputation and survival rate in a large group of patients treated for infrapopliteal CLI with endovascular or open procedures, although more post-operative complications were reported in the open group. These findings support the continued use of both treatments while stressing the importance of minimizing surgical trauma to reduce wound complications. [ABSTRACT FROM AUTHOR]

Objectives The COhorte de Patients ARTériopathes (COPART) Risk Score is a risk score assessing the 1 year outcome of patients who received inpatient treatment because of their peripheral arterial occlusive disease (PAOD). The COPART Risk Score consists of six variables each of which is allocated a different number of points (age, history of myocardial infarction, C-reactive protein, ankle–brachial index, estimated glomerular filtration rate, medication with antiplatelet agents, statins and renin–angiotensin system inhibitors). Methods 129 consecutive claudicants were included in a prospective trial with an average follow up of 8.8 (± 0.7) years. All patients were hospitalized for their first endovascular procedure to the pelvic and/or femoropopliteal arteries. The endpoints were all cause mortality and cardiovascular (CV) death. The COPART Risk Score was calculated for the three patient cohorts (low risk: 52 patients [40.3%]; medium risk: 41 patients [31.8%]; high risk: 36 patients [27.9%]). Results During the follow up period 23.1% ( n = 12) of patients in the low risk group, 34.1% ( n = 14) of patients in the medium risk group, and 63.9% ( n = 23) of patients in the high risk group died. CV death occurred in 11.5% in the low, 22.0% in the medium, and 41.7% in the high risk groups. The three groups differed significantly with regard to all cause and CV mortality ( p < .0001 and p = .001). Conclusions The COPART Risk Score is a suitable instrument to predict long-term all cause and CV mortality in claudicants preceding their first peripheral intervention. [ABSTRACT FROM AUTHOR]

Objective To evaluate the efficacy and bleeding complications associated with a low-dose thrombolysis protocol for thromboembolic lower extremity arterial occlusions. Design A retrospective cohort study. Materials and methods A retrospective analysis was performed using data from all consecutive patients who underwent catheter-directed, intra-arterial thrombolysis for thromboembolic lower extremity arterial occlusions between January 2004 and May 2013. All patients were treated on a standard surgical ward. Endpoints were incidence of bleeding complications, duration of thrombolysis, angiographic patency rate, 30-day mortality rate, and amputation-free rate at 6 months. Results Of the 171 cases analyzed, 129 cases underwent low-dose thrombolysis and 42 underwent high-dose thrombolysis. No major bleeding complications occurred in the low-dose group versus 5% in the high-dose group ( p = .01). The median duration of thrombolysis was 67 hours (4–304 hours) in the low-dose and 49 hours (2–171 hours) in the high-dose group ( p = .027). Angiographic patency was restored in 67% of the cases in the low-dose group versus 79% of the high-dose group ( p = .17). The 30-day mortality rates were 1% in the low-dose versus 5% in the high-dose group ( p = .09). However, this higher mortality rate was not related to bleeding complications. Major amputation-free rates at 6 months were 81% in the low-dose group and 88% in the high-dose group ( p = .22). Conclusions Based on this data series, low-dose thrombolysis for thromboembolic lower extremity arterial occlusions is as effective as high-dose thrombolysis; however, the risk of major bleeding complications is substantially lower when using low-dose thrombolysis. [ABSTRACT FROM AUTHOR]

Background A number of reviews have reported the influence of exercise therapy (ET) for the treatment of intermittent claudication (IC). However, a complete overview of different types of ET is lacking. The aim of this meta-analysis was to study the effect of supervision on walking capacity in patients with IC. It was hypothesized that there was a positive treatment effect in relation to the intensity of supervision and improvement in walking capacity (i.e., a "dose-response" hypothesis). Methods A systematic search in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases was performed. Only randomized controlled trials (RCTs) evaluating the efficacy of an ET in IC were included. Type of supervision, treadmill protocol, length of ET, total training volume, and change in walking distance were extracted. RCTs were categorised according to type of support: no exercise, walking advice, home-based exercise (HB-ET), and supervised exercise therapy (SET). A standardised mean difference between pre- and post-training maximal walking distance (MWD) and pain-free walking distance (PFWD) was calculated for all subgroups at 6 weeks, and 3 and 6 months of follow up. Results Thirty studies involving 1406 patients with IC were included. The overall quality was moderate-to-good, although number of included patients varied widely (20-304). The intensity of supervision was directly related to MWD and PFWD. SET was superior to other conservative treatment regimens with respect to improvement in walking distances at all follow-ups. However, the difference between HB-ET and SET at 6 months of follow up was not significant. Conclusion Supervised exercise therapy for intermittent claudication is superior to all other forms of exercise therapy. Intensity of supervision is related to improved walking distance. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to compare externally supported thin wall knitted polyester (P-EXS) and externally unsupported thin wall knitted polyester (P-non-EXS) for above-knee (AK) femoro-popliteal bypass grafting. Design: A prospective multicenter randomised clinical trial. Material and methods: Between 1999 and 2008, 265 AK femoro-popliteal bypass grafts (6 mm in diameter) were performed, including 136 P-EXS and 129 P-non-EXS. The selection of patients was based on the presence of disabling claudication or critical ischaemia. Follow-up took place at 3, 6, 12, 18, and 24 months and included clinical examination and duplex ultrasonography. The main end points of this study were primary patency rates at one and two years. Secondary end points were mortality, and primary assisted and secondary patency rates. Cumulative patency rates were calculated with life-table analysis and log-rank testing. Results: The 1-year primary, primary assisted and secondary patency rates were 65%, 70% and 84%, respectively, for P-EXS and 76% (p = 0.05), 82% (p = 0.03) and 88% (p = 0.35), respectively, for P-non-EXS. Two-year primary, primary assisted and secondary patency rates were 45%, 57% and 70%, respectively, for P-EXS and 62% (p = 0.003), 75% (p = 0.005) and 84% (p = 0.02), respectively, for P-non-EXS. The overall mortality rate after two years was 11.3%. Conclusion: In above-knee femoro-popliteal bypass grafting patency rates of externally supported knitted polyester grafts were inferior to their unsupported counterpart. ISRCTN: At the time this study started this number was not the standard. [ABSTRACT FROM AUTHOR]

Abstract: Aim: To investigate if a relationship exists between hospital waiting time to major amputation and outcome. Method: All patients undergoing major lower limb amputation in England between April 2002 and March 2006 were identified from the Hospital Episodes Statistics (HES) data. Amputations related to trauma or malignancy were excluded. The length of wait (LOW), from date of admission to date of major amputation was calculated. A two-level regression model was used to investigate if LOW had a significant effect on recovery time and in-hospital mortality. Results were adjusted for age, sex, Charlson score, Social Deprivation, mode of intervention (bypass/angioplasty/no intervention) and mode of admission (emergency/elective). Results: 14 168 major amputations were identified. 12 884 (90.9%) had no intervention prior to amputation on that admission. Length of Wait (LOW) significantly prolonged recovery in men (Exponential Estimate 1.01 1.01–1.02 p < 0.0001) and women (EE 1.02 1.01–1.02 p < 0.0001) and increased in-hospital mortality in men (OR 1.02 1.02–1.03 p < 0.0001). Risk of in-hospital death increased by 2% for each day waited. Conclusion: Delays in decision making or in getting a patient into the operating theatre have a negative effect on patient outcome in terms of overall length of stay and mortality after major lower limb amputation. [Copyright &y& Elsevier]

Abstract: Introduction and objectives: Infrainguinal bypass surgery (BPG) is accompanied by significant 30-day mortality and morbidity, including early graft failure. The goal of this study is to identify patient- and procedure-specific factors which predict the rate of early graft failure in contemporary practice. Methods: Data was obtained from the private sector National Surgical Quality Improvement Program, a prospective, validated database collected between 2005 and 2008 from 211 hospitals, using primary and modifier Current Procedural Terminology codes for BPG. The primary endpoint was graft failure at 30 days. Procedural parameters, patient demographics and clinical variables were analyzed by univariate and multivariate methods. Results: There were 9217 BPG procedures (limb salvage, 49%; infrapopliteal distal anastomosis, 43%; prosthetic 32%) with patient variables: age 67 ± 12 years, male 64%, diabetes 44%, dialysis 7.4%. Mortality was 2.4%, major morbidity was 17.3%, and graft failure rate was 6.3% at 30 days. Multivariate predictors of graft failure demonstrated correlation (p-value, OR) with female gender (p = 0.0054, 1.29), limb salvage indication (p < 0.0001, 1.60), infrapopliteal anastomosis (p < 0.0001, 2.15), composite graft (p = 0.0436, 1.82), current smoking (p = 0.0007, 1.36), impaired sensorium (p = 0.0075, 2.13), emergency procedure (p < 0.0001, 2.03), previous vascular procedure (p = 0.0005, 1.39), and platelets >400K (p = 0.0019, 1.49). High-risk composite constructs utilizing these significant predictive factors can identify cohorts of patients with up to a 98-fold increase in odds of early graft failure. Conclusions: These results describe common risk factors that correlate with early graft thrombosis including the unique description of its association with thrombocytosis. Additional risk factors thus identify a subset of patients who are at highest risk for early BPG failure. This data may be used to refine patient selection. [Copyright &y& Elsevier]

Abstract: Objectives: Prognostic research in patients with peripheral arterial disease (PAD) is scarce and determinants of outcome are mainly studied in males. The current management of PAD in women is based on evidence from, at best, mixed populations. We therefore assessed risk and prognostic factors in 313 men and 169 women from the Dutch Bypass Oral anticoagulants or Aspirin Study of whom long-term follow-up data were available. Method: The primary composite outcome event was vascular death, myocardial infarction, stroke, or major amputation during 5 years of follow-up. Variables with a p-value <0.2 in the univariate analyses were added to the multivariate Cox proportional hazards model. Results: Females were older (71 vs. 68 years; p < 0.01), had more advanced PAD (critical limb ischemia (CLI) 52.1 vs. 42.2%; p = 0.04), more often had peripheral bypass surgery as primary intervention (50.5 vs. 32.5%; p < 0.01), and had more often hypertension (48.5 vs. 33.2%; p < 0.01) than males. Males were more often smokers (63.6 vs. 53.3%; p = 0.03) and had more prior myocardial infarctions (18.5 vs. 10.1%; p = 0.02). In total 170 events occurred, 74 (44%) in females and 96 (31%) in males. Overall, independent risk factors for the primary outcome event were age and critical limb ischemia. Independent risk factors in males were: age (HR: 1.06, 95% CI: 1.03–1.09), critical limb ischemia (HR: 1.7, 95% CI: 1.05–2.7), and diabetes mellitus (HR: 1.7, 95% CI: 1.01–2.8) and in females critical limb ischemia (HR: 3.5, 95% CI: 2.0–6.1), ABI≤0.9 (HR: 2.8, 95% CI: 1.2–6.1), and femorocrural bypass (HR: 1.9, 95% CI: 1.1–3.3). Although sex was not an independent risk factor in the overall analysis, women younger than 60 years had an increased risk for cardiovascular events compared to men of that age (HR: 4.9, 95% CI: 1.8–13.6), whereas no difference was seen above 60 years of age. Conclusions: Risk factors for cardiovascular events in patients with PAD differ between men and women. To our knowledge, this is the first study that shows such a bad outcome in female patients younger than 60 years of age. More awareness leading to early diagnosis and optimal treatment might improve long-term clinical outcome in (young) women with PAD. [Copyright &y& Elsevier]

Abstract: Objectives: Although international guidelines state that supervised exercise therapy (SET) should be offered to all patients with intermittent claudication (IC), SET appears to be underutilised in clinical practice. The aim of this study was to document current opinions of Dutch vascular surgeons on SET as treatment option for peripheral arterial occlusive disease (PAOD). Materials and methods: Vascular surgeons and fellows in vascular surgery were asked to complete a 24-question survey either at the 2011 Annual Meeting of the Dutch Society for Vascular Surgery or online. Results: Ninety-one participants, including 83 vascular surgeons (51% of all Dutch vascular surgeons), completed the survey. The respondents would refer 75.4% of newly diagnosed patients with IC for SET. SET was considered less useful in patients with IC and major (cardiopulmonary) co-morbidity or a significant iliac artery stenosis. In critical limb ischaemia, the combination of SET and angioplasty was considered useful in 71.9%. Respondents regarded patient satisfaction (63.3%) and improvement in pain-free or maximal walking ability (26.6%) as clinically most relevant goals of SET. Most (84.4%) agreed that SET should also include lifestyle management. Conclusion: Although the vast majority of Dutch vascular surgeons consider SET as an important treatment option for PAOD, SET should receive more emphasis in clinical practice since arguments not to refer for SET are outdated. Furthermore, vascular surgeons agree that lifestyle management should be integrated in SET. [Copyright &y& Elsevier]

Abstract: Objectives: Various indications for internal iliac artery (IIA) revascularisation have been reported. Revascularisations for gluteal ischaemia and buttock claudication remain controversial and uncommon. The objective of the study was to assess the patency of direct conventional revascularisations (CRs) of the IIA in patients with aortoiliac occlusive disease because few studies have focussed on this specific topic. Materials and methods: The charts of all patients who underwent CR of the IIA, between August 2000 and January 2009, were retrospectively reviewed. We recorded for each patient preoperative vascular work-up. All patients were tested for patency on January 2009. A computed tomography (CT) scan was requested if the duplex scan casts any doubt with regard to patency. If non-patent, the last date for confirmed patency was kept for the analysis. Functional outcomes at the proximal level were also collected. Results: We studied 40 patients with occlusive disease. Buttock claudication was observed in 27 patients (66%), including eight (20%) in whom these symptoms were isolated. The 13 other patients had distal claudication or rest pain and documented proximal ischaemia, justifying the IIA revascularisations. We performed 44 conventional direct revascularisations of the IIA concomitant to aorto- or iliofemoral bypasses in these patients. The overall postoperative patency rate was 89%. Five early occlusions of the IIA remained asymptomatic. The median duration of follow-up was 39 months (3–86 months). The survival rate was 95% at 1 year and 86% at 5 years. The primary patency rate of the IIA was 89% at 1 year and 72.5% at 5 years. Buttock claudication disappeared in 23 of the 27 patients (85%), who were symptomatic at the proximal level prior to surgery. Conclusion: Direct IIA concomitant revascularisation has an acceptable patency rate in patients undergoing aorto- or iliofemoral bypasses for occlusive disease. When feasible, this technique appears to be safe for the treatment and prevention of buttock claudication. [Copyright &y& Elsevier]

Abstract: Objectives: To compare expanded polytetrafluoroethylene (ePTFE) prosthesis and collagen-impregnated knitted polyester (Dacron) for above-knee (AK) femoro-popliteal bypass grafts. Design: A prospective multicentre randomised clinical trial. Patients and Methods: Between 1992 and 1996, 228 AK femoro-popliteal bypass grafts were randomly allocated to either an ePTFE (n =114) or a Dacron (n =114) vascular graft (6mm in diameter). Patients were eligible for inclusion if presenting with disabling claudication, rest pain or tissue loss. Follow-up was performed and included clinical examination and duplex ultrasonography at all scheduled intervals. All patients were treated with warfarin. The main end-point of this study was primary patency of the bypass graft at 2, 5 and 10 years after implantation. Secondary end-points were mortality, primary assisted patency and secondary patency. Cumulative patency rates were calculated with life-table analysis and with log-rank test. Results: After 5 years, the primary, primary assisted and secondary patency rates were 36% (confidence interval (CI): 26–46%), 46% (CI: 36–56%) and 51% (CI: 41–61%) for ePTFE and 52% (CI: 42–62%) (p =0.04), 66% (CI: 56–76%) (p =0.01) and 70% (CI: 60–80%) (p =0.01) for Dacron, respectively. After ten years these rates were respectively 28% (CI:18-38%), 31% (CI:19-43%) and 35% (CI: 23-47%) for ePTFE and 28% (CI: 18-38%), 49% (CI: 37-61%) and 49% (CI: 37-61%) for Dacron. Conclusion: During prolonged follow-up (10 years), Dacron femoro-popliteal bypass grafts have superior patency compared to those of ePTFE grafts. Dacron is the graft material of choice if the saphenous vein is not available. [Copyright &y& Elsevier]

Objectives: To evaluate the relationship between C-Reactive Protein (hsCRP), a serum marker of inflammation, and endothelial dysfunction in patients with intermittent claudication. Design, Patients and Methods: Cross-sectional study with stratified sampling on dependent variables of age, genre, hypertension, hyperlipidemia, diabetes, smoking status and ankle-brachial index (ABI) to select 156 patients from a target population of 4,100 patients with claudication. We assessed the flow-mediated arterial dilation (FMAD) as a reporter of endothelial function and plasma levels of hsCRP and fibrinogen. Results: Patients with a FMAD<3% (range for the lowest 5% of healthy subjects) had increased levels of plasma hsCRP (6.3 vs 2.3mg/L; p<0.05) and fibrinogen (351vs 302mg/L; p<0.05) in comparison to those with FMAD>3%. There was a negative correlation between hsCRP and FMAD(r=−0.465; p<0.05). Conclusion: Impaired endothelial dysfunction is association with increased plasma concentrations of inflammatory markers, and both may have a role in the aetiopathogenesis of peripheral arterial disease. [Copyright &y& Elsevier]

Purpose: To compare long-term patency of Heparin-Bonded Dacron (HBD) and Human Umbilical Vein (HUV) vascular prostheses in above-knee femoro-popliteal bypass surgery. Design: A prospective randomized multi-centre clinical trial. Patients and methods: Femoro-popliteal bypasses were performed in 129 patients between 1996 and 2001. After randomization 70 patients received an HUV and 59 an HBD prosthesis. Patients were followed up every three months during the first postoperative year and yearly thereafter. The median follow-up was 60 months (range 3–96 months). Graft occlusions were detected by duplex scanning, angiography or surgical exploration. Results: The cumulative primary patency rates were 79%, 66% and 58% at 1, 3 and 5 years postoperatively. Primary patency rates for HUV were 74%, 64% and 58% at 1, 3 and 5 years and 84%, 68% and 58% for HBD, respectively (log-rank test, p=0.745). Overall secondary patency rates were 82%, 72% and 61% at 1, 3 and 5 years postoperatively. The overall cumulative limb salvage at 5 years follow-up was 89% (CI 80%–91%) and was not dependent on graft type. Smoking (p=0.019), number of patent crural arteries (p=0.030) and previous cerebro-vascular events (p=0.030) were significant predictors of graft occlusion. Conclusion: There was no difference in long-term graft performance between HUV and HBD for above knee infrainguinal bypass. [Copyright &y& Elsevier]

Objectives: To assess prospectively the early time course of Transforming Growth Factor beta-1 (TGFβ-1), basic Fibroblast Growth Factor (bFGF) and Tumor Necrosis Factor alpha (TNFα) as possible contributors to restenosis development after angioplasty. Design: Prospective Study. Methods: The levels of the soluble forms of these factors in the early response to Percutaneous Transluminal Angioplasty (PTA) in the arteries of the lower limb were prospectively assessed. 32 patients with peripheral arterial occlusive disease (PAOD), presenting with intermittent claudication (Fontaine stage IIb) were scheduled for angioplasty treatment. Serum levels of TGFβ-1, TNFα and bFGF were assessed before intervention, 15 and 60 minutes after, 24 hours after as well as 2 and 4 weeks after intervention. We compared the distribution patterns between patients treated with balloon angioplasty and patients who required secondary stent implantation. Endpoint was the development of restenosis within 6 months after interventional treatment, defined as a lumen diameter reduction of more than 50% by ultrasound measurement compared to the result after PTA. Results: The patients who later developed restenosis had significantly higher levels of TGFβ-1 at 15 minutes, 24 hours and 2 weeks after PTA (p <0.05). TNFα and bFGF were only detected in a few patients and no significant change of serum levels was observed. Conclusion: The results demonstrate a possible role of TGFβ-1 in the formation of restenosis after PTA. [Copyright &y& Elsevier]

Objective: To assess the values of transcutaneous oxygen tension (TcPO2) capable of predicting above-the-ankle amputation in diabetic patients diagnosed for critical limb ischemia (CLI) according to the criteria of the TransAtlantic Inter-Society Consensus. Design: Retrospective study. Methods: From January 1999 to December 2003, 564 diabetic patients were consecutively hospitalized for CLI in one limb. Revascularization with angioplasty or bypass graft was performed when possible and, if not possible, prostanoid therapy was used. In patients in whom therapies did not relieve the rest pain or the gangrene was extended above the Chopart joint, an above-the-ankle-amputation was performed. After treatment TcPO2 values were evaluated in all patients at the dorsum of the foot. Results: Fifty-five (9.8%) patients underwent an above-the-ankle amputation: 22 of 420 patients who underwent angioplasty, 17 of 117 patients who underwent bypass (14.5%) and 16 of 27 patients in whom revascularization was not possible. Post-treatment TcPO2, measured by a receiver operating characteristic (ROC) curve, showed a value 34mmHg as the best threshold for determining the need for revascularization, with an area under the curve of 0.89 (95%CI 0.85–0.94). Using logistic regression analysis the probability of above-the-ankle amputation for this threshold is 9.7% and reduces to 3% for TcPO2 >40mmHg. Conclusion: TcPO2 levels<34mmHg indicate the need for revascularization, while for values ≥ 34<40mmHg this need appears less pressing, although there remains a considerable probability of amputation. TcPO2 levels greater than 40mmHg suggest that revascularization is dependent on the severity of tissue loss and possible morbidity caused by the procedure. [Copyright &y& Elsevier]

Objective: To report the long term results of ultrasonic superficial femoral artery endarterectomy (USFAE). Design: Retrospective study. Patients and methods: From January 1998 to June 2004 218 USFAE were performed in 202 selected patients (178 males, 192 procedures) with a median age of 65 years (46-87 years). Indications for operation were disabling intermittent claudication in 137 procedures (68%), rest pain in 24 procedures (12%), and limb salvage in 41 procedures (20%). The new medical technology of ultrasonic endarterectomy is based on the application of the mechanical vibrations in the range of low frequency ultrasound. The ultrasonic device consists of the ultrasonic generator, acoustic unit and the flexible wave concentrators with special working tips in the shape of a ring. Follow up consisted of clinical evaluation, ankle-brachial index measurements and duplex scanning. Results: The mean follow-up time was 30.1 months. The mean length of the endarterectomised SFAs was 29cm (range, 15–43cm). The five year cumulative primary patency rate by means of life table analysis was 45.8±4.4% (SE). Percutaneous transluminal balloon angioplasty and surgical re-interventions were performed in thirty three and five patients respectively resulting in a primary assisted patency rate of 57.5±4.1%. The five year secondary patency rate was 65.6±3.8%. Limb salvage was achieved in 35 of the 41 patients with gangrene. Conclusions: The long term results of ultrasonic SFA endarterectomy suggest this is an effective technique. [Copyright &y& Elsevier]