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Purpose: This study aimed to identify prognostic factors and provide a novel image classification method for patients with Fournier gangrene. Materials and methods: A total of 40 consecutive patients diagnosed with Fournier gangrene between January 2003 and December 2022 were enrolled. Demographic characteristics, clinical presentations, management strategies, and outcomes were retrospectively analyzed. Results: The overall survival rate was 87.5% (35/40). Diabetic foot history, chronic kidney disease, end-stage renal disease, or peripheral arterial occlusive disease were significantly (P < 0.05) more common in nonsurvivors than in survivors. Among the parameters of the Fournier's Gangrene Severity Index, only the initial creatinine level was significantly associated with mortality (P = 0.02). Nevertheless, the Fournier's Gangrene Severity Index score with a cutoff score of 9 remained a useful indicator of death (P = 0.04). Patients with grade II (extensive) invasion determined by whole abdominal computed tomography had significantly higher mortality rates than those with grade I (nonextensive) (37.5% versus 6.3%, P = 0.04). Conclusion: Patients with a history of diabetic foot, chronic kidney disease, end-stage renal disease, and peripheral arterial occlusive disease had a higher risk of death. Early image computed tomography studies are essential for evaluating the risk and extent of the disease. More predictive tools are needed to assess this aggressively infectious disease. [ABSTRACT FROM AUTHOR]

Introduction: The aim was to determine the cost-effectiveness and cost-utility of additional hyperbaric oxygen therapy (HBOT) compared to standard care (SC) for ischaemic diabetic foot ulcers (DFUs) regarding limb salvage and health status. Methods: An economic analysis was conducted, comprising cost-effectiveness and cost-utility analyses, with a 12-month time horizon, using data from the DAMO2CLES multicentre randomised clinical trial. Cost-effectiveness was defined as cost per limb saved and cost-utility as cost per quality-adjusted life year (QALY). The difference in cost effectiveness between HBOT+SC and SC alone was determined via an incremental cost-effectiveness ratio (ICER). Results: One-hundred and twenty patients were included, with 60 allocated to HBOT+SC and 60 to SC. No significant cost difference was found in the intention-to-treat analysis: €3,791 (bias corrected and accelerated [BCA] 95% CI, €3,556 -€-11,138). Cost per limb saved showed an ICER of €37,912 (BCA 95% CI €-112,188--€1,063,561) for HBOT+SC vs. SC. There was no significant difference in mean QALYs: 0.54 for HBOT+SC vs. 0.56 for SC alone (-0.02; BCA 95% CI -0.11-0.08). This resulted in a cost-utility of minus €227,035 (BCA 95% CI €-361,569,550-€-52,588) per QALY. Subgroup analysis for Wagner stages III/IV showed an ICER of €19,005 (BCA 95%CI, €-18,487-€264,334) while HBOT did not show any benefit for Wagner stage II. Conclusions: HBOT as an adjunct to SC showed no significant differences in costs and effectiveness for patients with DFUs regarding limb salvage and health status. However, for patients with Wagner stage III/IV ischaemic DFUs there was a trend towards better effectiveness and cost-effectiveness. [ABSTRACT FROM AUTHOR]

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Chronic limb-threatening ischemia is challenging to treat because of the complex patient population, heterogeneity of limb presentations, and complicated arterial pathology. To meet this challenge, vascular surgeons need a broad range of skills to appropriately tailor interventions to each patient's specific needs. One tool in the armamentarium for patients with extensive arterial occlusive disease below the knee is an inframalleolar bypass. However, these procedures require a systematic approach to surgical planning and a high degree of technical competence. We describe our approach to inframalleolar bypass for limb preservation in suitable patients with advanced tibial artery disease.

Diseases of the vascular system and cardiovascular diseases are among the leading causes of morbidity and mortality. General practitioners, therefore, play a decisive role in the basic care of this specific patient group. Measurable and modifiable risk factors for the development of atherosclerotic diseases are smoking, diabetes mellitus, hypertension, obesity (especially abdominal obesity), psychosocial factors, and lipid metabolism disorders. The general clinical examination allows initial conclusions to be drawn about a patient's vascular health. Peripheral arterial disease, aortic pathologies, aneurysms of the peripheral arteries, ischemia syndromes of the upper extremities, carotid artery stenosis and mesenteric ischemia are characterized in part by typical symptoms and can already be detected in the current medical history. General treatment principles for treatment of vascular diseases are now largely well documented and explained in the current guidelines of the various specialist societies. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the mortality after treatment with a paclitaxel (PTX)-coated device and with uncoated devices of iliac, femoropopliteal, and below-the-knee lesions in dialysis patients. Methods: Retrospective mortality analysis of dialysis patients with peripheral artery disease who underwent treatment of iliac, femoropopliteal, and/or infrapopliteal lesions with PTX-coated or uncoated devices. Results: Between 2010 and 2018, 1125 dialysis patients were treated with iliac and/or femoropopliteal and/or infrapopliteal lesions. In all, 359 patients were selected for this retrospective analysis. Of those, 122 patients were treated with uncoated devices without crossover to a PTX-coated device during follow-up and 237 patients were treated with a PTX-coated device. Mean follow-up time was 27.38±24.76 months (range=0–103). For the entire cohort, the overall mortality was 95.1% after uncoated treatment and 75.9% after PTX treatment (p<0.001). After propensity score matching (n=119), overall mortality was 95.0% after uncoated treatment and 78.2% after PTX treatment (p<0.001). For the entire cohort, multivariate logistic regression analysis revealed age (p=0.002) and critical limb ischemia (p<0.001) as independent predictors for mortality. PTX treatment was a protective factor for mortality (p<0.001). Conclusion: Mortality in dialysis patients is in general high and higher after use of uncoated devices compared with PTX-coated devices. Mortality predictors were risk factors and disease severity but not PTX treatment. Clinical Impact: After the publication of Katsanos's metaanalyses, the uncertainty regarding PTX device safety in peripheral interventions in patients mainly without end-stage renal insufficiency was initially considerable. The present study for the first time investigates the potential long-term mortality risk of dialysis patients following PTX device treatment of PAD. In contrast to a recent meta-analysis, this real-world study could show a better survival after PTX treatment in comparison to uncoated devices. [ABSTRACT FROM AUTHOR]

Peripheral arterial occlusive disease (PAOD) is a clinical manifestation of systemic atherosclerosis and is always associated with cerebrovascular disease and various complications. The aim of our study is to evaluate the relationship between the coronavirus disease 2019 (COVID‐19) infection and the subsequent PAOD development. A retrospective cohort study was conducted and individuals with COVID‐19 infection were identified from the TriNetX analytics platform. A total of 2 206 065 patients with COVID‐19 infection and 2 206 065 patients without COVID‐19 infection were recruited after exclusion and matching. The primary outcome was the development of PAOD after the COVID‐19 infection. The Cox proportional hazard regression was adopted to yield the hazard ratio (HR) and 95% confidence interval (CI) of PAOD between groups. After the whole follow‐up period, the incidence of PAOD was significantly higher in the COVID‐19 group at both the 3‐month follow‐up (HR: 1.27, 95% CI: 1.24–1.30) and the 12‐month follow‐up (HR: 1.33, 95% CI: 1.31–1.35) The Kaplan‐Meier analysis with the log‐rank test demonstrated a higher cumulative probability of PAOD in the COVID‐19 group compared to the non‐COVID‐19 group (p < 0.001). In stratified analysis using 65 years as the threshold, both age groups in the COVID‐19 group exhibited a higher risk of PAOD. Similarly, in the sex and race stratified analysis, the COVID‐19 group performed a higher risk of PAOD in both subgroups. In conclusion, the COVID‐19 infections are strongly associated with an increment of PAOD incidence. [ABSTRACT FROM AUTHOR]

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This case report presents the management of a 69-year-old man with an extensive history of peripheral vascular disease including 2 previous failed right femoral to distal bypasses and a left above-the-knee amputation who presented with right lower extremity rest pain and non-healing shin ulcers. A redo bypass was performed for limb salvage via the obturator foramen to avoid his extensively scarred femoral region. The postoperative course was uneventful and the bypass remained patent in the early period. This case demonstrates the usefulness of the obturator bypass to provide revascularization and avoid amputation in a patient with chronic limb-threatening ischemia and multiple failed bypasses. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the correlation between the Society for Vascular Surgery (SVS) Wound, Ischemia and foot infection (WIfI) classification system and clinical outcomes for 1-year limb amputation-free survival (AFS), freedom from reintervention, and wound healing rate in a cohort of patients affected by chronic limb-threatening ischemia treated exclusively by endovascular procedures. We analyzed a prospective, consecutive cohort of 203 patients (203 limbs) who underwent infrainguinal endovascular revascularization at a single center between March 2018 and January 2021. These patients were stratified into clinical stages 1 to 4 based on the SVS WIfI classification and categorized into two groups: WIfI 1 to 3 (n = 101 limbs) and WIfI 4 (n = 102 limbs). The SVS objective performance goals of 1-year limb AFS, freedom from reintervention, and wound healing were compared between the groups and assessed using the Kaplan-Meier method. Angiographic lesion characteristics and angioplasty details were compared. The average age was 72.4 years (44.3% male, 85.2% had hypertension, 80.3% had diabetes, and 87.7% had tissue loss). There were statistical differences between the groups in 1-year limb AFS Kaplan-Meier rate between WIfI clinical stages 1 to 3 group and WIfI clinical stage 4 group (82% vs 66%, respectively; P <.001), but there was no statistical difference in freedom from reintervention and wound healing rates between the groups (70% vs 64% [ P =.62] and 74% vs 79% [ P =.90], respectively). Owing to angiographic lesion characteristics, femoropopliteal and infrapopliteal segment distributions were similar between the groups, but there was a statistical difference in target lesion location to tibial vessels (55.4% vs 71.6%, respectively; P =.025). In this cohort of patients with chronic limb-threatening ischemia, SVS WIfI clinical stage 4 had worse results in the 1-year limb AFS rate, but there was no statistical difference in freedom from reintervention and wound healing rates between the groups. [ABSTRACT FROM AUTHOR]

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Summary: Background: Diagnostic work‐up of leg ulcers is time‐ and cost‐intensive. This study aimed at evaluating ulcer location as a diagnostic criterium and providing a diagnostic algorithm to facilitate differential diagnosis. Patients and Methods: The study consisted of 277 patients with lower leg ulcers. The following five groups were defined: Venous leg ulcer, arterial ulcers, mixed ulcer, arteriolosclerosis, and vasculitis. Using computational surface rendering, predilection sites of different ulcer types were evaluated. The results were integrated in a multinomial logistic regression model to calculate the likelihood of a specific diagnosis depending on location, age, bilateral involvement, and ulcer count. Additionally, neural network image analysis was performed. Results: The majority of venous ulcers extended to the medial malleolar region. Arterial ulcers were most frequently located on the dorsal aspect of the forefoot. Arteriolosclerotic ulcers were distinctly localized at the middle third of the lower leg. Vasculitic ulcers appeared to be randomly distributed and were markedly smaller, multilocular and bilateral. The multinomial logistic regression model showed an overall satisfactory performance with an estimated accuracy of 0.68 on unseen data. Conclusions: The presented algorithm based on ulcer location may serve as a basic tool to narrow down potential diagnoses and guide further diagnostic work‐up. [ABSTRACT FROM AUTHOR]

Introduction: Currently, there is an increase in severe stages of peripheral arterial occlusive disease (PAOD) with critical ischemia. This seems to correspond to the general demographic change as well as a consequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic of the last 3 years. The now established and accepted interventional/endovascular approach for severe lower leg PAOD in experienced hands is still considered the first-line treatment but from the authorsʼ perspective crural/pedal venous bypass is experiencing a renaissance. Material and methods: Compact narrative review of the current state of crural/pedal bypass surgery in Germany and Saxony-Anhalt (SA) combined with selective references from the current scientific medical literature and own clinical experiences. Results: The current statistics of case-related diagnosis-related groups (DRG) data show that, especially with the occurrence of the corona pandemic, a decrease in inpatient case numbers of patients with PAOD stage IIB can be observed nationwide and also in SA. The severe PAOD stages have remained approximately the same in case numbers but increased in SA. The risk stratification based on the wound, ischemia and foot infection (WIFI) classification offers the possibility to be able to make statements about the risk of amputation, benefits and type of revascularization measures. The length of the occlusion, occlusion site of the affected vessels and degree of calcification are taken into account in the global limb anatomic staging system (GLASS) to assess the prognosis. The evaluation of the case-based hospital statistics from 2015 to 2020 showed a constant use of femorocrural/femoropedal bypass surgery in Germany as well as a slight increase in reconstruction using femorocrural bypasses in SA, which seems to correlate with the tendency for an increase in the number of cases of severe PAOD. Summary: Parameter-based objectification of the severity of critical limb ischemia should be included in the indications for placement of a crural/pedal bypass. The WIFI classification and GLASS are suitable for this purpose as a relative prognosis of success is also possible. The treatment of critical limb ischemia by crural/pedal bypass surgery continues to find a constant application in Germany and SA. [ABSTRACT FROM AUTHOR]

Objectives: The Hyperview® is a hyperspectral camera, which can be used to assess the microcirculation of patients with peripheral arterial disease (PAD) and/or diabetes mellitus (DM). It measures local tissue oxygenation in concentrations of oxyhemoblobin (OXY), deoxyhemoglobin (DEOXY), and O2-saturation (O2-SAT) in arbitrary units. The aim of this validation study is to assess whether the Hyperview® is able to monitor microcirculatory changes after revascularization in patients with PAD. Methods: In this prospective observational cohort study, 50 patients with PAD were included who were scheduled for endovascular, hybrid, or open revascularization. The ankle-brachial index (ABI), systolic toe pressure (TP) (in case of DM), and a set of Hyperview® measurements of the plantar region were recorded before and after treatment. Changes in pre- and postoperative measurements were assessed with the paired t-test. Results: Some 38 patients underwent endovascular revascularization and eight patients underwent hybrid or open vascular surgical revascularization. After revascularization, the ABI improved from 0.58 to 0.80 (p < 0.001). OXY increased from 72.6 to 77.8 (p = 0.134). DEOXY decreased from 69.1 to 55.0 (p < 0.001). O2-SAT increased from 51.3 to 58.1 (p < 0.001). TP improved from 50.6 to 61.9 mmHg (p = 0.065) but was measured in only 16 patients. Conclusion: The Hyperview® is able to observe changes in the microcirculation after revascularization in terms of DEOXY and O2-SAT. The results of this study are a promising step into the validation of the Hyperview®. [ABSTRACT FROM AUTHOR]

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This study aimed to investigate the potential association between glaucoma and peripheral arterial occlusive disease. The study recruited patients, including 101,309 with glaucoma and 1,860,528 without a glaucoma diagnosis, from a population of 2 million patients in the Longitudinal Health Insurance Database. Propensity score matching was performed between the two groups, matching for age, sex, and comorbidities. In total, 95,575 patients with glaucoma and 95,575 patients without glaucoma were analyzed for their risk of developing peripheral arterial occlusive disease. The analysis of the data revealed that the glaucoma group had a higher incidence density (ID = 4.13) of peripheral arterial occlusive disease than the non-glaucoma group (ID = 3.42). The relative risk for the glaucoma group was 1.21 (95% C.I. = 1.15–1.28). Cox proportional hazard model analysis indicated that the glaucoma group had a higher risk of developing peripheral arterial occlusive disease (HR = 1.18; 95% C.I. = 1.12–1.25). The subgroup analysis of the risk of PAOD showed that the glaucoma group had a higher risk of developing peripheral arterial occlusive disease in the age group of 20 to 39 (p for interaction = 0.002). In conclusion, patients with glaucoma were associated with a higher risk of subsequent peripheral arterial occlusive disease compared with those without a diagnosis of glaucoma. [ABSTRACT FROM AUTHOR]

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Copyright of Gefaesschirurgie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Chronic limb-threatening ischemia is challenging to treat because of the complex patient population, heterogeneity of limb presentations, and complicated arterial pathology. To meet this challenge, vascular surgeons need a broad range of skills to appropriately tailor interventions to each patient's specific needs. One tool in the armamentarium for patients with extensive arterial occlusive disease below the knee is an inframalleolar bypass. However, these procedures require a systematic approach to surgical planning and a high degree of technical competence. We describe our approach to inframalleolar bypass for limb preservation in suitable patients with advanced tibial artery disease.

INTRODUCTION: Recently published studies on peripheral arterial occlusive disease (PAOD) have revealed marked sex disparities in patient selection and treatment outcomes. In a recent retrospective study with data from 11 different countries, Portugal was highlighted as one of the countries with greater sex discrepancies related to PAOD treatment. We aimed to analyze sex specific differences in the treatment of symptomatic PAOD, concerning different variables, in a single hospital center, in Portugal. METHODS: Data on treatment of symptomatic PAOD patients from October 1st, 2020, to December 31st, 2021, were retrospectively collected from clinical registries from a single hospital center in Portugal. Different variables and post-operative outcomes were analyzed dichotomized by sex, with descriptive statistics. Statistical analyses were conducted using the IBM Statistical Package for Social Sciences (SPSS) software v28. RESULTS: A total of 220 patients, 15,9% female and 84,1% male, were treated for PAOD, in the selected period, in a hospital center from Portugal. Female patients were older (mean age of 73.8 years versus 69.5 years in male); were less likely to be treated for intermittent claudication (3% versus 6% of men); more often treated at a more advanced stage of the disease with trophic lesions (91% versus 74% of men); more likely to be offered primary major amputation (14% versus 3% of male patients); less likely to be taking statins as part of PAOD medical management (65.7% versus 77.8% of male); and had a higher 90-day mortality rate (17.1% versus 6.5% in men). They were also more frequently treated with endovascular procedures (40%) than with OSR (26%). CONCLUSION: Remarkable sex discrepancies in the treatment of PAOD were found in our hospital center. This study brings awareness to the scientific medical community for sex disparities in the management of patients with PAOD.

Background: Cardiovascular diseases are the main cause of death in Europe with a relevant socioeconomic burden. A screening program for vascular diseases in asymptomatic persons with a defined risk constellation can lead to an early diagnosis. Objective: The study examined a screening program for carotid stenosis, peripheral arterial occlusive disease (PAOD) and abdominal aortic aneurysms (AAA) in persons without any known vascular disease with respect to demographic data, risk factors, pre-existing conditions, medication intake, detection of pathological findings and/or findings requiring treatment. Material and methods: Test subjects were invited using various information material and filled in a questionnaire on cardiovascular risk factors. The screening took place with measurement of the ABI and duplex sonography as a monocentric prospective single arm study within 1 year. Endpoints were the prevalence of risk factors and pathological and/or results requiring treatment. Results: A total of 391 persons participated, 36% presented with at least 1 cardiovascular risk factor, 35.5% with 2 and 14.4% with 3 or more. The sonography showed results requiring control with a carotid stenosis of < 50–> 75% or occlusion in 9%. An AAA with a diameter of 3.0–4.5 cm was diagnosed in 0.9% and a pathological ABI < 0.9 or > 1.3 in 12.3%. The indications for a pharmacotherapy were found in 17% and no operation was recommended. Conclusion: The practicability of a screening program for carotid stenosis, PAOD and AAA of a defined risk population was shown. Vascular pathologies that required treatment were hardly found in the catchment area of the hospital. Consequently, the implementation of this screening program in Germany based on the collected data cannot currently be recommended in this form. [ABSTRACT FROM AUTHOR]

Aim: Alzheimer's dementia (AD) is a slowly progressing neurodegenerative disease, characterized by beta‐amyloid deposition and neurofibrillary tangles. Peripheral atherosclerosis may deteriorate these processes via endothelial cell dysfunction and microvascular impairment. Cilostazol – a phosphodiesterase 3 inhibitor – is a standard treatment for peripheral arterial occlusive disease and a potential treatment for preserving cognitive function in AD patients. We aimed to determine whether cilostazol is beneficial in AD patients with peripheral arterial occlusive disease by evaluating Cognitive Abilities Screening Instrument (CASI) domains. Methods: We conducted a retrospective case–control study of 62 AD patients in Taiwan. Thirty‐one patients had peripheral arterial occlusive disease and were receiving cilostazol plus acetylcholinesterase inhibitors (AchEIs) or N‐methyl d‐aspartate antagonists, whereas 31 others were receiving AchEIs. Therapeutic responses were measured using neuropsychological assessments. The CASI was administered at baseline and 12 months later; different domains were analyzed between the groups using univariate and multivariate analyses. Results: Age, sex, education duration, ApoE ε4 gene status, and initial Mini‐Mental State Examination scores were not different between the two groups. Except for fluency, no CASI domains showed a statistical difference between the groups. A significant difference was observed in category fluency (P = 0.010). In the logistic regression analysis, after adjusting for covariate effects, category fluency still showed a significant difference between the groups (P = 0.013). Conclusions: In AD patients with peripheral arterial occlusive disease who have received Food and Drug Administration‐approved pharmacotherapy, cilostazol, as an antiplatelet, may help to preserve general cognitive function, with significant preservation in category fluency. Geriatr Gerontol Int 2023; 23: 194–199. [ABSTRACT FROM AUTHOR]

Abstract Background Peripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for “hard” clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability. Methods In this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective “hard” outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes. Discussion By focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative (“all-comer”) population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected. Trial registration ClinicalTrials.gov NCT04238546

Septic embolism associated with infective endocarditis (IE) is the occlusion of a blood vessel caused by an infected thrombus traveling through the bloodstream resulting in ischemia and/or infarction. Septic embolism can result in ischemia and/or infarction due to vascular occlusion and infection, resulting in inflammation and possible abscess formation. Systemic embolization generally occurs in left-sided IE, causing stroke, blindness due to embolism or endophthalmitis, splenic or renal infarct, limb ischemia, or even acute myocardial infarction. Here, we report a case of acute on chronic limb-threatening ischemia due to septic embolism in patient with IE. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the influence of a noise optimized virtual monoenergetic reconstruction algorithm (VMI+) on the image quality and assessability of dual energy (DE) computed tomography angiography (CTA) of the lower extremity runoff. A total of 118 lower extremity runoff CTA performed on a 3rd generation DE-CT scanner in 109 patients (54 females; 75.6 ± 9.5 years) were included in this retrospective study. Axial image stacks were reconstructed with a standard 120 kV setting and VMI+ of different keV levels. Objective image quality criteria (contrast attenuation, signal-to-noise [SNR] and contrast-to-noise ratio [CNR]) were measured. Two radiologists evaluated subjective image quality regarding intraluminal attenuation and image noise using a 5-point Likert scale. Diagnostic accuracy for significant stenosis (>75%) and vessel occlusion was assessed for 120 kV and 50 keV VMI+ images rated by two radiologists. In all patients, a digital subtraction angiography (DSA) rated by on board-certified radiologist served as the standard of reference. Intraluminal attenuation was highest in 40/50 keV VMI+ while SNR were similar to 120 kV images. In subjective assessment, intraluminal contrast of 50 keV images was deemed superior compared to 120 kV despite higher image noise. Sensitivity, specificity, and accuracy for detection of a vessel occlusion were similar in 50 keV VMI+ compared to 120 kV (70%/92%/84%; 70%/91%/83%; p < 0.001) but 13 of 118 (11%) lower leg runoffs were only assessable with 50 keV VMI+. VMI+ reconstructions improve assessability of DE-CTA by increased luminal attenuation with consistent image noise, also allowing the evaluation of lower leg arterial segments inassessable with standard reconstructions. Providing higher intraluminal attenuation and similar image noise compared with conventional reconstructions, 50 keV VMI+ may be appropriate for routine evaluation of DE-CTA. [ABSTRACT FROM AUTHOR]

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]

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Introduction: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK). Material and Methods: X treme To uch-Neo [MagicTouch PTA] Si rolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success. Results: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; p<.001) and BTK lesions (52.8±19.2 mm Hg vs 70.7±37 mm Hg; p<.037). At 12 months, wound healing rate was 33/39 (84.6%). Conclusions: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD. [ABSTRACT FROM AUTHOR]

Objectives: Patients with peripheral arterial occlusive disease (PAOD) are at risk of worsening limb symptoms, major adverse cardiovascular events and exhibit an impaired life expectancy. There is a lack of evidence on the extent of pharmacological secondary prevention in PAOD patients. This study assesses treatment patterns of antithrombotic agents in symptomatic PAOD patients. Methods: This is a retrospective cohort study using data from the second largest insurance fund in Germany, BARMER. We included symptomatic PAOD patients undergoing in-hospital treatment with an index admission between 1 January 2010 and 31 December 2017. Outcomes were proportions of single antiplatelets (SAPT), dual antiplatelets (DAPT), vitamin-K antagonists (VKA), or direct oral anticoagulants (DOAC) in the 12 months prior and 6 months after the index hospitalization. Non-parametric cumulative incidence for competing risks was estimated to account for censoring and death after discharge from hospital stay. Patient flows were visualised by alluvial diagrams. All analyses were stratified by intermittent claudication (IC) and chronic limb-threatening ischaemia (CLTI). The protocol was registered to ClinicalTrials.gov (NCT03909022). Results: A total of 80,426 unique patient encounters were identified. Mean age was 72.7 (46.3% female). Amongst all patients, 25.6% were on SAPT, 4.1% on DAPT, 9.1% on VKA, 3.9% on DOAC, 3.9% on both antiplatelets and oral anticoagulation, and 53.3% without any antithrombotic therapy during the 12 months before index stay. The estimated cumulative incidence was 37.9% SAPT, 14.8% DAPT, 7.5% VKA, 4.3% DOAC, 7.4% both, and 28.1% without any antithrombotic therapy during the 6 months after index stay. The considerable increases in antiplatelet therapy were mainly driven by the group of patients without antithrombotics before index stay. As compared with IC, patients who suffered from CLTI received less often antiplatelets but more often anticoagulants both before and after index stay. Conclusions: Utilisation rates of antithrombotic therapy increased considerably after in-hospital treatment for PAOD. Yet, remarkably high rates of symptomatic patients without any blood-thinning therapy constitute a major concern with respect to adequate secondary prevention of PAOD patients. [ABSTRACT FROM AUTHOR]

Background: Peripheral arterial occlusive disease (PAOD) is a peripheral artery disorder that increases with age and often leads to an elevated risk of cardiovascular events. The purposes of this study were to explore the underlying competing endogenous RNA (ceRNA)-related mechanism of PAOD and identify the corresponding immune cell infiltration patterns. Methods: An available gene expression profile (GSE57691 datasets) was downloaded from the GEO database. Differentially expressed (DE) mRNAs and lncRNAs were screened between 9 PAOD and 10 control samples. Then, the lncRNA-miRNA-mRNA ceRNA network was constructed on the basis of the interactions generated from the miRcode, TargetScan, miRDB, and miRTarBase databases. The functional enrichment and protein-protein interaction analyses of mRNAs in the ceRNA network were performed. Immune-related core mRNAs were screened out through the Venn method. The compositional patterns of the 22 types of immune cell fraction in PAOD were estimated through the CIBERSORT algorithm. The final ceRNA network and immune infiltration were validated using clinical tissue samples. Finally, the correlation between immune cells and mRNAs in the final ceRNA network was analyzed. Results: Totally, 67 DE_lncRNAs and 1197 DE_mRNAs were identified, of which 130 DE_mRNAs (91 downregulated and 39 upregulated) were lncRNA-related. The gene ontology enrichment analysis showed that those down- and upregulated genes were involved in dephosphorylation and regulation of translation, respectively. The final immune-related core ceRNA network included one lncRNA (LINC00221), two miRNAs (miR-17-5p and miR-20b-5p), and one mRNA (CREB1). Meanwhile, we found that monocytes and M1 macrophages were the main immune cell subpopulations in PAOD. After verification, these predictionswere consistentwith experimental results. Moreover, CREB1 was positively correlated with naive B cells (R = 0.55, p = 0.035) and monocytes (R = 0.52, p = 0.049) and negatively correlated with M1 macrophages (R = -0.72, p = 0.004), resting mast cells (R = -0.66, p = 0.009), memory B cells (R = -0.55, p = 0.035), and plasma cells (R = -0.52, p = 0.047). Conclusion: In general, we proposed that the immune-related core ceRNA network (LINC00221, miR-17-5p, miR-20b-5p, and CREB1) and infiltrating immune cells (monocytes and M1 macrophages) could help further explore the molecular mechanisms of PAOD. [ABSTRACT FROM AUTHOR]

Objectives: In this study, perioperative properties and early outcomes of patients who underwent combined Temren rotational atherectomy (RA) and drug-coated balloon (DCB) angioplasty treatment for complex femoropopliteal lesions in a single center were reported. Methods: Between June 2019 and February 2020, 40 patients who underwent combined Temren RA and DCB treatment due to critical lower limb ischemia or claudication-limiting daily living activities were retrospectively evaluated. Results: The mean age of patients was 73.2 ± 7.8 years and the majority of the patients were male (65%). Of the patients, 17 had critical limb ischemia and 23 had lifestyle-limiting claudication. Pathologies were total occlusion in 33 limbs and critical stenosis in seven limbs. Nine patients previously underwent endovascular intervention or surgery. The mean total occlusion length was 140.9 ± 100.9 (range, 20–360) mm in patients with chronic total occlusion. There was an additional iliac artery pathology in 5 and below the knee pathology in 8 patients. Rotational atherectomy was possible in all cases. Flow-limiting dissection was seen in six patients (15%). Provisional stent was performed to these patients. Following Temren RA, all patients underwent DCB. Adequate vascular lumen (less than 30% stenosis) was provided in all patients and the symptoms regressed. No distal embolization was encountered. Access site complications (17.5%) were small hematoma in four patients, ecchymosis in two patients, and pseudoaneurysm of the femoral artery in one patient. The mean follow-up was 13.55 ± 4.2 (range, 1–18) months. Re-occlusion was seen in three patients (7.5%) (n = 2 at 2 months and n = 1 at 4 months). Of these patients, two had required open revascularization via femoropopliteal bypass graft with common, superficial femoral, and popliteal artery endarterectomy and one had required femoro-posterior tibial artery bypass. Four minor toe amputations (10%) were performed to reach complete wound healing in the critical limb ischemia patients. A below-knee amputation was performed in a 94-year-old patient with long segment stenosis at the end of a 1-month follow-up period. There was no mortality after follow-ups. The Kaplan–Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) which was 92.3%. The decrease in the Rutherford levels after the procedure was found to be statistically significant in 36 patients (p < 0.001). The increase in the ankle–brachial index after the procedure was found to be statistically significant in 36 patients (p < 0.001). Conclusions: Combined use of Temren RA with adjunctive DCB is safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions. [ABSTRACT FROM AUTHOR]

Abstract Background Free flaps have been a useful modality in the management of lower extremity osteomyelitis particularly in limb salvage. This study aimed to determine the factors affecting the outcome of free flap reconstruction in the treatment of osteomyelitis. Methods This retrospective study assessed 65 osteomyelitis patients treated with free flap transfer from 2015 to 2020. The treatment outcomes were evaluated in terms of the flap survival rate, recurrence rate of osteomyelitis, and amputation rate. The correlation between outcomes and comorbidities, causes of osteomyelitis, and treatment modalities was analyzed. The following factors were considered: smoking, peripheral artery occlusive disease, renal disease, diabetic foot ulcer, flap types, using antibiotic beads, and negative pressure wound therapy. Result Among the 65 patients, 21 had a severe peripheral arterial occlusive disease. Osteomyelitis developed from diabetic foot ulcers in 28 patients. Total flap failure was noted in six patients, and osteomyelitis recurrence was noted in eight patients, for which two patients underwent amputation surgery during the follow-up period. Only end-stage renal disease had a significant correlation with the recurrence rate (odds ratio = 16.5, p = 0.011). There was no significant relationship between outcomes and the other factors. Conclusion This study showed that free flaps could be safely used for the treatment of osteomyelitis in patients with comorbidities and those who had osteomyelitis developing from diabetic foot ulcers. However, care should be taken in patients diagnosed with end-stage renal disease.

The Sars coronavirus 2019 (COVID-19) pandemic has resulted in increased morbidity and mortality; however, there is limited understanding of how excess mortality is distributed among different racial and ethnic subgroups and vascular diseases. We conducted a retrospective, cross-sectional study design using data from the United States (US) Center for Disease Control (CDC) Wide Ranging Online Data for Epidemiologic Research (Wonder) database. The database contains death certificate information for all US residents by cause of death as ascertained by the treating physician. We examined the trends of excess death by vascular disease specific mortality among different racial and ethnicity subgroups. Excess deaths were defined as the difference between observed numbers of deaths in specific time periods and the expected numbers of deaths in the same time periods. We compared mortality rates during the reference period of 2018-2019 (pre-pandemic) with the study period of 2020-2021 (pandemic years). We also compared excess mortality rates among racial and ethnic subgroups (Non-Hispanic white, Non-Hispanic Black, and Hispanic individuals). Vascular disease was categorized by administrative diagnostic codes (ICD10): Vascular disease (I26, I82, I70-73, I74) and its subtypes Arterial thrombosis (I74), venous thromboembolism (I26, I82) and atherosclerotic disease (I70-73). Compared to 2018-2019, there was a 1.3 % excess mortality associated with vascular disease, a 12.2 % excess mortality due to arterial thrombosis mortality, and an 8.0 % excess mortality due to thromboembolism in 2020-2021. Black individuals demonstrated higher excess vascular mortality (6.9 %) compared to white individuals (-0.3 %) P <.001, higher excess venous thromboembolism mortality (14.1 % vs 5.1 % P = 0.002) and higher atherosclerosis mortality (2.1 % vs -2.6 % P = 0.002). Hispanics compared to white individuals had higher excess vascular mortality (5.1 % vs -0.3 % P = 0.03) and excess venous thromboembolism mortality (24.2 % vs 5.1 % P < 0.001). The COVID-19 pandemic has led to a significant and persistent increase in vascular mortality. Excess mortality has disproportionately affected Black and Hispanic individuals compared to white individuals, highlighting the need for further studies to address and eliminate these health care disparities. [ABSTRACT FROM AUTHOR]

Background: Peripheral arterial disease is a progressive atherosclerotic disease with symptoms ranging from an intermittent claudication to acute critical limb ischemia and amputations. Drug-coated balloons and stents were developed to prevent neo-intimal proliferation and restenosis after percutaneous transluminal angioplasty. Randomized controlled trials showed that drug-coated, notably paclitaxel-coated, devices reduce restenosis, late lumen loss, and the need for target lesion re-vascularization compared with uncoated ones. However, the size of these trials was too small to prove superiority for "hard" clinical outcomes. Moreover, available studies were characterized by too restrictive eligibility criteria. Finally, it remains unclear whether paclitaxel-coated balloons may impair long-term survival. Alternative drug-coated balloons, the so-called limus-based analogs, have been approved for clinical use in patients with peripheral arterial disease. By encapsulating sirolimus in phospholipid drug nanocarriers, they optimize adhesion properties of sirolimus and provide better bioavailability.Methods: In this investigator-initiated all-comer open-label phase III randomized controlled trial, we will evaluate whether sirolimus-coated balloon angioplasty is non-inferior and eventually superior, according to a predefined hierarchical analysis, to uncoated balloon angioplasty in adults with infra-inguinal peripheral arterial disease requiring endovascular angioplasty. Key exclusion criteria are pregnancy or breastfeeding, known intolerance or allergy to sirolimus, and participation in a clinical trial during the previous 3 months. The primary efficacy outcome is the composite of two clinically relevant non-subjective "hard" outcomes: unplanned major amputation of the target limb and endovascular or surgical target lesion re-vascularization for critical limb ischemia occurring within 1 year of randomization. The primary safety outcome includes death from all causes.Discussion: By focusing on clinically relevant outcomes, this study will provide useful information on the efficacy and safety of sirolimus-coated balloon catheters for infra-inguinal peripheral arterial disease in a representative ("all-comer") population of unselected patients. As regulatory agencies had raised safety concerns in patients exposed to paclitaxel-coated devices (versus uncoated ones), collect mortality data up to 5 years after randomization will be collected.Trial Registration: ClinicalTrials.gov NCT04238546. [ABSTRACT FROM AUTHOR]

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The incidence of chronic limb-threatening ischemia in diabetic patients is increasing. The factors influencing outcome after infrapopliteal revascularization in these patients are largely unknown. Therefore, this study aims to identify the impact of perioperative glucose control on the long-term outcomes in this patient cohort, and furthermore to identify other factors independently associated with outcome. Consecutive diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia were identified. Patients' demographics, procedural details, daily capillary blood glucose, and hemoglobin A1C levels were collected and analyzed against the study end points using Kaplan-Meier and Cox regression analysis. A total of 437 infrapopliteal target vessels were successfully crossed in 203 patients. Amputation-free survival by Kaplan-Meier (estimate (standard error)%) was 74 (3.3)% and 63 (3.7)%, primary patency was 61 (4.2)% and 50 (4.9)%, assisted primary patency was 69 (5.2)% and 55 (6.1)%, and secondary patency was 71 (3.8)% and 59 (4.1)% at 1 year and 2 years, respectively. Cox regression analysis showed high perioperative capillary blood glucose levels to be an independent predictor of binary restenosis (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.31-1.1.78; P =.015). Postprocedural dual-antiplatelet therapy was found to be an independent predictor of amputation-free survival (HR, 1.69; 95% CI, 1.04-2.75; P =.033), and freedom from major adverse limb events (HR: 1.96; 95% CI, 1.16-3.27; P =.023) and baseline estimated glomerular filtration rate was significantly associated with better amputation-free survival (HR, 0.52; 95% CI, 0.31-0.87; P =.014). Poor perioperative glycemic control is associated with a higher incidence of restenosis after infrapopliteal revascularization in diabetic patients. Dual antiplatelet therapy is associated with better outcomes in this group. [Display omitted] [ABSTRACT FROM AUTHOR]

Objectives: The Hyperview® is a novel camera that applies hyperspectral imaging to project local concentrations of oxyhaemoglobin (OXY), deoxyhaemoglobin (DEOXY) and O2-saturation (O2-SAT) in a map. In this pilot validation study, we assessed inter - and intra-observer agreement for measuring OXY, DEOXY and O2-SAT in healthy participants. Methods: The plantar region of the right foot was assessed with the Hyperview® in 50 healthy participants. Two consecutive pictures were taken by the same observer, followed by two images by a second observer. Measurements were performed without and with standardization (a static device for both the foot and the Hyperview camera). Inter- and intra-observer agreements were expressed as Intraclass Correlation coefficients (ICC) with their 95% confidence interval (CI). A score <0.40 indicates poor agreement, 0.40–0.59 fair, 0.60–0.74 good and 0.75–1.00 excellent agreement. Bland and Altman plots were also generated. Results: Without standardization, the ICC values between the observers for OXY, DEOXY and O2-SAT ranged from 0.70 to 0.83. The intra-observer agreement of both observers ranged from 0.36 to 0.83. With standardization, the ICC values between the observers ranged from 0.80 to 0.82 and intra-observer agreement varied from 0.75 to 0.92. Four Bland and Altman plots were generated of the measurements of OXY by observers 1 and 2. Conclusions: When standardization is used, the Hyperview® camera is a reliable device with excellent intra- and inter-observer agreements for the assessment of OXY, DEOXY and O2-SAT. In future research, the inter- and intra-observer agreements of the camera should be investigated in patients with diabetes and/or peripheral arterial disease. [ABSTRACT FROM AUTHOR]

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Purpose: Acute lower limb ischemia (ALI) is a sudden decrease in arterial limb perfusion due to an arterial blockage, threatening limb and life. Catheter-directed thrombolysis (CDT) is a minimally invasive procedure to remove such obstructions. However, approximately one-third of patients endure a re-occlusion after successful CDT. This study aimed to investigate the short- and long-term outcomes of CDT for early (<1 year) and late (>1 year) re-occlusions., Material and Methods: This retrospective multicenter study reviewed patients from 2 medical centers with an acute arterial re-occlusion of the lower limb after successful CDT between December 1996 and April 2021. The primary endpoints were angiographic success, defined as thrombus dissolution over 95% with outflow to at least 1 crural artery, and clinical success, defined as a score of ≥1 on the Rutherford scale for assessing changes in clinical status. Secondary endpoints included bleeding complications, patency, amputation, and mortality. Kaplan-Meier analyses were used to estimate patency, survival, and freedom from amputation., Results: Seventy-seven cases were included, with 52 early re-occlusions (<1 year) and 25 late re-occlusions (>1 year). The median time to re-occlusion since the last CDT treatment was 4 months in the early re-occlusion group and 24 months in the late re-occlusion group. Angiographic success was achieved in 73% of early and 64% of late re-occlusions. Clinical success rates were 80.8% for the early and 80.0% of the late re-occlusion cases. Major bleeding occurred in 2% of the early and 8% of the late re-occlusion group. Patients were followed up until symptoms or signs of limb ischemia were resolved, with a median follow-up time of 15 months for the early and 22 months for the late re-occlusion group. During follow-up, secondary re-occlusions were observed in 59.6% of the early and 44% in the late group. Cumulative amputation rates at 1, 5, and 8 years were 36%, 36%, and 52% for early and 18%, 30%, and 30% for the late re-occlusions, respectively., Conclusion: In our experience, CDT is an effective short-term revascularization strategy for the majority of patients with both early and late re-occlusions. Long-term results are limited by secondary re-occlusions and limb loss., Clinical Impact: Catheter-directed thrombolysis (CDT) is a well-established treatment for acute lower limb ischemia (ALI). Re-occlusions after successful treatment are, however, observed in almost a third of the patients. Yet, the outcomes of CDT for re-occlusions for patients who were previously treated with CDT are not well known. This study showed that CDT is effective in achieving revascularization in cases of early and late re-occlusion after treatment for ALI, but the risk for further re-occlusions is high. Future studies should focus on maintaining patency after successful CDT for ALI., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: One of the authors of this article is the editor-in-chief of the journal. To avoid a conflict of interest, an alternate member of the Editorial Board handled this submission.

Objective: The objective of this study was to examine the short- and midterm outcomes of catheter-directed thrombolysis (CDT) for acute lower limb ischemia (ALI), classes Rutherford 1 and 2, with specific attention to functional outcome., Methods: This retrospective study included patients with ALI treated with CDT from 2 vascular centers between May 2018 and April 2021. Cases were analyzed in groups according to the Rutherford (1 and 2) classification. The primary endpoint was functional outcome during follow-up, assessed by Rutherford's chronic limb ischemia classification. Functional outcomes over time were analyzed by generalized estimating equations. Kaplan-Meier analysis was used to estimate reintervention, amputation, survival, and reintervention-free survival rates., Results: Two hundred cases were included (Rutherford 1, n = 51; Rutherford 2, n = 149). Total median treatment duration was 27 hours in the Rutherford 1 group and 39 hours in the Rutherford 2 group ( P = 0.120). Initial clinical success was high (Rutherford 1, 82% vs Rutherford 2, 89%; P = 0.253). Complications were comparable between the 2 groups: major bleeding 8% vs 10% ( P = 0.634), major amputation 4% vs 7% ( P = 0.603), and mortality 6% vs 6% ( P = 0.967). Median follow-up was 32 months (0-63 months). During follow-up, there was a high number of reinterventions (43%) and amputations (20%) in patients with Rutherford 1 limb ischemia, which was comparable to patients with Rutherford 2 limb ischemia. Fifty-six percent of the patients with Rutherford 1 limb ischemia reaching 2 years of follow-up were asymptomatic, 20% had mild and 16% had moderate to severe claudication. Initial clinical success following CDT and not immediately threatened ischemia at presentation are associated with improved functional outcomes during follow-up ( P < 0.001 and P = 0.009, respectively)., Conclusions: In our cohort, CDT was effective in reestablishing arterial flow for not immediately threatened ALI. Patients with Rutherford 1 limb ischemia who receive CDT had a more favorable functional outcome than patients with more severe limb ischemia (Rutherford 2). However, reinterventions were required frequently, and there was a substantial risk of complications., Clinical Impact: Acute lower limb ischemia (ALI) does not immediately jeopardize limb survival in patients with Rutherford 1 limb ischemia but can induce disabling claudication. In such patients, catheter-directed thrombolysis (CDT) is often performed to improve functional outcome. However, previous reports warned about the complications of CDT, and so far, mid- and long-term functional outcomes have not been reported. This study, in which a large cohort of patients with ALI was included, demonstrates a high technical success of CDT for not immediately threatened ALI with more favorable functional outcomes when compared with those with threatened limbs. Nevertheless, major complications pose a serious risk, and the need for reinterventions in the long term is high., Competing Interests: Declaration of Conflicting InterestsThe authors declare the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: One of the authors of this article is the editor-in-chief of this journal. To avoid a conflict of interest, an alternate member of the Editorial Board handled this submission.

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]

Objectives: The aim was to report the mid-term outcomes of Jetstream™ rotational atherectomy device in complex femoropopliteal lesions.Methods: Between November 2016 and April 2018, 55 patients who were treated with rotational atherectomy and adjunctive balloon angioplasty due to complex femoropopliteal lesions were retrospectively scanned.Results: Fifty-five patients who underwent endovascular treatment with rotational atherectomy for chronic total occlusive femoropopliteal lesions were included in the study. Technical success rate was 100%. The mean age was 63 (±10.5) years. The cohort included 25 (45.4%) diabetics and 45 (81.8%) current smokers. The mean length of the lesions was 20.8 ± 11.2 cm. Chronic total occlusive lesions were detected in 35 (63.6%) patients, and mixed-type steno-occlusive lesions were detected in 20 patients (36.4%). Thirty-three (60%) lesions were moderate or severely calcified. Adjunctive balloon angioplasty was performed with plain old balloon angioplasty (POBA) on 31 (56.4%) patients and with drug-coated balloon angioplasty on 24 (43.6%) patients. After adjunctive balloon angioplasty, flow limiting dissection was observed in 20 (36.3%) patients, and 17 (30.9%) patients needed stent implantation. The Kaplan-Meier analysis method estimated that the overall primary patency rates at 12 and 24 months were 81.8% and 70.9%, respectively. Overall, secondary patency rates at 12 and 24 months were 94.5% and 80%. No statistically significant differences of 24-month primary patency and secondary patency rates were found between patients treated with drug-coated balloon angioplasty and POBA as an adjunctive therapy, even though primary patency (83.3% vs. 61.3%, p = .06) and secondary patency (91.7% vs. 71%, p = .56) rates of drug-coated balloon angioplasty were slightly higher than POBA. Patients with claudication had better primary patency (90.5% vs. 58.8%, p = .001) and secondary patency (100% vs. 67.6%, p = .004) rates than patients with critical limb ischemia at 24 months. Significant differences between patients who did and did not stop smoking were found in 24-month primary patency (57% vs. 88%, p = .007) and secondary patency (67% vs. 96%, p = .007). Six patients underwent unplanned amputation. There were eight (14.5%) mortalities during follow-up.Conclusions: Rotational atherectomy with adjunctive balloon angioplasty has satisfactory technical success rates and mid-term outcomes. As an adjunctive method, there was no difference between drug-coated balloon angioplasty s and POBAs. Smoking cessation is always the first-step treatment to improve mid-term patency results. Patients with critical limb ischemia have worse patency results compared to the patients with claudication. [ABSTRACT FROM AUTHOR]