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Background: The treatment of acute lower limb ischemia (ALLI) has evolved over the last several decades with the availability of several new treatment modalities. This study was undertaken to evaluate the contemporary presentation and outcomes of ALLI patients., Methods: We retrospectively analyzed data from a prospectively collected database of all patients who presented to our tertiary referral hospital with acute ischemia of the lower extremity between May 2016 and October 2020. The cause of death was obtained from the Michigan State Death Registry., Results: During the study period, 233 patients (251 lower limbs) were evaluated for ALLI. Seventy-three percent had thrombotic occlusion, 24% had embolic occlusion, and 3% due to a low flow state. Rutherford classification of ischemia severity was 7%, 49%, 40%, and 4% for Rutherford grade I, IIA, IIB, and III, respectively. Five percent underwent primary amputations, and 6% received medical therapy only. The mean length of stay was 11 ± 9 days. Nineteen percent of patients were readmitted within 30 days of discharge. At 30 days postoperatively, mortality was 9% and limb loss was 19%. On multivariate analysis, 1 or no vessel runoff to the foot postoperatively was associated with higher 30-day limb loss. Patients with no run-off vessels postoperatively had significantly higher 30-day mortality. Cardiovascular complications accounted for most deaths (48%). At 1-year postoperatively, mortality and limb loss reached 17% and 34%, respectively., Conclusions: Despite advances in treatment modalities and cardiovascular care, patients presenting with ALLI continue to have high mortality, limb loss, and readmission rates at 30 days., (Published by Elsevier Inc.)

Objective: Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE., Methods: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days., Results: Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days., Conclusions: These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI., Competing Interests: Disclosures T.M. is the principal investigator for STRIDE and a consultant for Penumbra. P.M. is a speaker/consultant for Penumbra. F.A. is a speaker/consultant for Penumbra., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

The management of embolic acute limb ischaemia commonly involves determining aetiology and performing emergency invasive procedures. This detailed study aimed to determine the impact of manipulation of anticoagulation in the aetiology of emboli in acute limb ischaemia and determine the efficacy of primary anticoagulation therapy vs. invasive interventions. Material and methods: Data collection was conducted at a single institution on a cohort of patients presenting consecutively with embolic acute limb ischaemia over one year. Two groups were compared, one receiving anticoagulation as primary therapy with those undergoing invasive treatment as the internal comparison group. Results: A likely haematological causation was identified in 22 of 38 presentations, related to interruption of anticoagulation in cardiac conditions, the majority atrial fibrillation (n=12), or hypercoagulable states (n=10). Limb salvage was pursued in 36 patients employing anticoagulation (n=19) or surgical embolectomy (n=17) as the primary therapy in upper and lower limbs (n=17 vs n=19 respectively). Despite delays often well beyond six hours and a range of ischaemic severity in both groups, 35 of 36 patients achieved full or substantive restoration of function with improved perfusion. Regarding anatomical distribution of arterial disease and therapy, three patients with multi-level disease proceeded to embolectomy following anticoagulation. Embolectomy was undertaken most often for proximal emboli and more profound paralysis. Conclusions: Anticoagulation and coagulopathy are commonly implicated in the aetiology of arterial emboli, with omission of effective anticoagulation in atrial fibrillation being associated in almost 1/3 of presentations. Whilst more profound limb paralysis and proximal or multi-level disease tended to be managed surgically, primary anticoagulation therapy alone or with a secondary embolectomy was effective across the spectrum of ischaemia severity and despite significant delays beyond guideline recommendations.

Objectives: Acute lower extremity ischemia is one of the most common emergencies in vascular surgery and is a cause of considerable morbidity and mortality. The goal of this study was to evaluate outcomes of revascularization for acute lower extremity ischemia and to determine factors associated with perioperative morbidity and mortality., Methods: A total of 354 patients underwent urgent revascularization for acute lower extremity ischemia at an academic medical center between 2014 and 2019. A retrospective review of patients' demographics, comorbidities, etiology and severity of limb ischemia, and procedural characteristics was recorded. Outcomes, including postoperative complications, perioperative limb loss, and mortality, were analyzed., Results: The mean patient age was 69 ± 17 years, and 52% were females. 50% of patients presented with Rutherford Class IIb ischemia. Arterial embolization was the most common cause of limb ischemia, seen in 33% of cases. Open surgical revascularization was performed in 241 (68%) patients, while endovascular and hybrid approaches were utilized in 53 (15%) and 60 (17%) cases, respectively. Postoperative adverse events occurred in 44% of patients, including wound complications (11%), cardiac (5%) and pulmonary (16%) complications, strokes (4%), UTIs (10%), renal failure (14%), bleeding (5%), and compartment syndrome (3%). The rate of unplanned return to the operating room was 21%. Major adverse cardiovascular events were seen in 103 (29%) patients and major adverse limb events were seen in 57 (16%) patients. The median length of stay was 10 days (IQR = 4); 49% patients were discharged to skilled nursing facility and 19% were readmitted within 30 days.The rate of amputation during index admission was 10%, and perioperative mortality was 20%. Gender, tibial runoff, and etiology of limb ischemia were independent predictors of limb loss. Women had lower risk of limb loss than men (OR, 0.11; 95% CI, 0.023, 0.38). Poor tibial runoff (one-vessel or absence of flow below the knee) was a significant predictor of limb loss as compared to three-vessel runoff (OR, 14.92; 95% CI, 1.92, 115.88). Aneurysmal disease (OR, 38.35; 95% CI, 3.54, 42.45) and traumatic injuries (OR, 108.08; 95% CI, 8.21, 159.06) were the strongest predictors of amputation as compared to other etiologies of limb ischemia. Multivariate model identified ESRD (OR, 9.2; 95% CI, 1.8-46.3), degree of ischemia (class IIb or higher vs class IIa; OR, 3.5; 95% CI, 1.2-10.6), and age (OR, 1.5; 95% CI 1.1-2.0 for every 10 years) as independent predictors of perioperative mortality., Conclusions: Urgent revascularization for management of acute limb ischemia is associated with high morbidity and mortality. Elderly patients with ESRD presenting with severely threatened limbs have especially high risk of perioperative mortality and may not be ideal candidates for limb salvage., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: This study was carried out to assess the effectiveness of alprostadil (prostaglandin E1) when used as an adjuvant therapy with indirect revascularization in patients with critical limb ischemia (CLI) after the failure of direct revascularization (DR)., Methods: At our centers, 120 patients suffering from infrainguinal peripheral arterial disease with CLI underwent a failed trial of DR procedure, all revascularization procedures were endovascular. Median follow-up was 2 years and 2.5 years for patients with and without diabetes mellitus (DM). In the alprostadil group, the mean age was 63.41 ± 12.52; 36 (60%) for males and 24 (40%) for females. Post-endovascular intervention alprostadil was administrated immediately postoperatively by intravenous infusion of 40 μg alprostadil diluted in 100 ml of normal saline, over 2 hr every 12 hr for 6 days., Results: In the alprostadil group, the mean ± standard deviation (SD) of the baseline ankle-brachial index (ABI) was 0.45 ± 0.175, while the mean ± SD of ABI at the end of our study was 0.65 ± 0.216 with a difference from the baseline of 0.2 ± 0.041 (P value = 0.08, <0.05 meaning that it is significant). Our 1-month primary patency rate was 93.3%, while our 3- and 6-month patency rate was 92.9%. In the control group, the mean ± SD of the baseline ABI was 0.68 ± 0.22, while the mean ± SD of ABI at the end of our study was 0.69 ± 0.23 with a difference from the baseline of 0.01 ± 0.01 (P value >0.05 meaning that it is nonsignificant) 1-month patency rate was 89%, while 3- and 6-month patency rate was 75%. When we compared the patient's leg vessels before and after our intervention, we found that the percentage of the no-runoff-vessels group decreased from 10 (16.7%) to 4 (6.67%). One-runoff-vessel group percentage dropped from 40 (66.7%) to 36 (60%), whereas, in the two-runoff-vessel group, the percentage increased from 10 (16.7%) to 20 (33.3%). We evaluate leg arteries; we do no pedal arch intervention in the alpostradil group. Out of the total of 60 patients, limb salvage occurred in 58 (96.7%) patients, and 2 (3.3%) patients underwent below-the-knee amputation before the study ended., Conclusions: Our results show the efficacy and safety of alprostadil as an adjuvant therapy with indirect angiosomal revascularization in patients with tissue loss due to CLI., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Clinical guidelines recommend shared decision-making for treatment of peripheral artery disease (PAD), which requires understanding of patient perspectives and preferences. We conducted a focus group study of patients with symptomatic PAD to identify factors important and relevant to treatment choices, and to characterize aspects of the health care process that contribute to positive vs negative experiences apart from the specific treatment(s) received., Methods: Participants were recruited from an academic medical center over 2 years using a purposeful sampling approach based on a clinical diagnosis of symptomatic PAD (either claudication or chronic limb-threatening ischemia [CLTI]) confirmed by the abnormal ankle or toe brachial index. Focus groups were led by a nonphysician moderator, consisted of 5 to 12 participants, and were conducted separately for patients with CLTI and claudication. Audio recordings converted to verbatim transcripts were used for qualitative analysis., Results: A total of 51 patients (26 with CLTI and 25 with claudication) were enrolled and participated in focus groups. Major themes identified related to treatment preferences and decisions included specific interventions under consideration, the chance of technical success versus failure, anticipated degree of symptom improvement, outcome durability, and risk. Major themes related to the process of care included decision-making input, provider communication and trust, the timeline from diagnosis to definitive treatment, and compartmentalized care (including different venues of care)., Conclusions: The results provide insights into patient preferences, perspectives, and experiences related to PAD treatment. These observations can be used to inform patient-centered approaches to shared decision-making, communication, and assessment of PAD treatment outcomes., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Patients who present with lower extremity ischemia are frequently anemic and the optimal transfusion threshold for this cohort remains controversial. We sought to evaluate the impact of blood transfusion on postoperative major adverse cardiac events (MACE), including myocardial infarction, dysrhythmia, stroke, congestive heart failure, and 30-day mortality for these patients., Methods: All consecutive patients who underwent infra-inguinal bypass at our institution from 2011 to 2020 were included. Perioperative red blood cell transfusion was the primary exposure, and the primary outcome was MACE. Univariate and multivariable analyses were performed to assess the impact of patient and procedural variables, including red blood cell transfusion, stratified by hemoglobin (Hgb) nadir: <7, 7-8, and >8 g/dL., Results: Of the 287 patients reviewed for analysis, 146 (50.9%) had a perioperative transfusion (mean: 1.6 ± 3 units). Patients who received a transfusion had a mean nadir Hgb of 8.3 ± 1.0 g/dL, compared to 10.1 ± 1.7 g/dL without a transfusion. The overall incidence of MACE was 15.7% (45 of 287 patients). Univariate analysis demonstrated that MACE was associated with blood transfusion (P = 0.009), lower Hgb nadir (P = 0.02), and higher blood loss (P = 0.003). On multivariate analysis, transfusion was independently associated with MACE for patients with a Hgb nadir >8 g/dL (OR: 3.09; P = 0.006), but not for patients with Hgb nadir 7-8 g/dL (OR: 0.818; P = 0.77). Additionally, patients with MACE had significantly longer length of hospital stay than for patients without (13 vs. 7.7 days, P = 0.001)., Conclusions: For patients undergoing infra-inguinal bypass, receiving a red blood cell transfusion with a Hgb nadir >8 g/dL was associated with a 3-fold increase in MACE, with nearly twice the length of stay. For patients with a Hgb 7-8 g/dL, transfusion did not increase or reduce the incidence of MACE. These findings suggest no benefit of blood transfusion for patients with Hgb nadir >7 g/dL and harm for Hgb >8 g/dL, however causation cannot be proven due to the retrospective nature of the study and randomized studies are needed to confirm or refute these findings., (Copyright © 2021. Published by Elsevier Inc.)

Background: Anemia is potentially associated with increased morbidity and mortality following vascular surgery procedures. This study investigated whether peri-procedural anemia is associated with reduced 1-year amputation-free survival (AFS) in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI)., Methodology: A retrospective analysis of patients diagnosed with CLTI between February 2018-February 2019, who subsequently underwent revascularization, was conducted. Hemoglobin concentration measured at index assessment was recorded and stratified by WHO criteria. Subsequent peri-procedural red blood cell transfusions (RBC) were also recorded. The primary outcome was 1-year AFS. Kaplan Meier survival analysis and Cox's proportional hazard modelling were conducted to assess the effect of anemia and peri-procedure transfusion on outcomes., Results: 283 patients were analyzed, of which 148 (52.3%) were anemic. 53 patients (18.7%) underwent RBC transfusion. Patients with anemia had a significantly lower 1-year AFS (64.2% vs. 78.5%, P = 0.009). A significant difference in 1-year AFS was also observed based upon anemia severity (P = 0.008) and for patients who received RBC transfusion (45.3% vs 77.0%, P < 0.001). On multivariable analysis, moderately severe anemia was independently associated with increased risk of major amputation/death (aHR 1.90, 95% CI 1.06-3.38, P = 0.030). After adjusting for severity of baseline anemia, peri-procedural RBC transfusion was associated with a significant increase in the combined risk of major amputation/death (aHR 3.15, 95% CI 1.91-5.20, P < 0.001)., Conclusion: Moderately severe peri-procedural anemia and subsequent RBC transfusion are independently associated with reduced 1-year AFS in patients undergoing revascularization for CLTI. Future work should focus on investigating alternative measures to managing anemia in this cohort., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Patients with lower extremity wounds from diabetes mellitus or peripheral artery disease (PAD) have a risk of amputation as high as 25%. In patients with arterial disease, revascularization decreases the risk of amputation. We aimed to determine if the early assessment of arterial perfusion correlates with the risk of amputation., Methods: We retrospectively reviewed patients referred to the vascular clinic over 18 months with Rutherford Grade 5 and 6 chronic limb-threatening ischemia to determine if patients had a pulse exam done at the time the wound was identified and when ankle brachial index (ABI) testing to evaluate perfusion was performed. Kaplan Meier analysis was used to determine if the timing of ABI testing affected the time to revascularization, wound healing, and risk of amputation., Results: Ninety-three patients with lower extremity wounds were identified. Of these, 59 patients (63%) did not have a pulse exam performed by their primary care provider when the wound was identified. Patients were classified by when they underwent ankle brachial index testing to assess arterial perfusion. Twenty-four had early ABI (<30 days) testing, with the remaining 69 patients having late ABI testing. Patients in the early ABI group were more likely to have a pulse exam done by their PCP than those in the late group, 12 (50%) vs. 22 (32%), P = 0.03. Early ABI patients had a quicker time to vascular referral (13 days vs. 91 days, P < 0.001). Early ABI patients also had quicker times to wound healing than those in the late group (117 days vs. 287 days, P < 0.001). Finally, patients that underwent early ABI were less likely to require amputation (Fig. 1), although this did not reach statistical significance (P = 0.07)., Conclusions: Early ABI testing expedites specialty referral and time to revascularization. It can decrease the time to wound healing. Larger cohort studies are needed to determine the overall effect of early ABI testing to decrease amputation rates., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Patients with peripheral artery disease (PAD) present with claudication or chronic limb threatening ischemia (CLTI). CLTI patients have a more advanced stage of atherosclerosis and increased comorbidities compared to claudicants, and are at an elevated risk of major amputation and mortality after lower extremity revascularization (LER). However, the frequency of reinterventions for claudication and CLTI have not been compared. Our hypothesis is that patients with CLTI undergo more frequent reinterventions to prevent major amputation., Methods: A single-center retrospective chart review of consecutive patients undergoing lower extremity revascularization (LER) for PAD in 2013-2015 was performed. Patients were stratified based on indication for revascularization into claudication or CLTI. Patient characteristics, outcomes, and reinterventions were compared between the 2 groups., Results: There were 826 patients undergoing LER and 44% (N = 361) had CLTI. Patients treated for CLTI were more likely to be smokers (P < 0.001), to have diabetes (P< 0.001), chronic renal insufficiency (P< 0.001), end stage renal disease (P< 0.001), and cardiac disease (P< 0.001). CLTI patients were less likely to be on optimal medical management as reflected by decreased rate of aspirin (P< 0.001), ADP receptor/P2Y12 inhibitors (P< 0.001), and statins (P< 0.001) compared to patients with claudication. Patients with CLTI had significantly higher major amputation (3.7% vs. 0.2%, P< 0.001) and mortality (1.4% vs. 0.2%, P = 0.092) at 30 days. At long-term follow up, patients with CLTI had higher rates of major amputation (15.5% vs. 1.3%, P < 0.001) and mortality (37.1% vs. 18.1%, P < 0.001) compared to patients with claudication. There was a significant difference in mean follow-up time between the 2 cohorts (claudication: 3.7 ± 1.5 years versus CLTI: 2.6 ± 1.8 years, P < 0.001). There was no significant difference in the ipsilateral reintervention rate between the 2 groups (claudication: 39.6% vs. CLTI: 42.7%, P = 0.37) or the mean number of ipsilateral reinterventions (claudication: 2.0 ± 1.6 vs. CLTI: 2.0 ± 1.7). However, after adjusting for follow-up time, the mean number of reinterventions per year was significantly higher for CLTI patients compared to patients with claudication (1.4 ± 2.2 vs. .6 ± 0.7 intervention per year, P < 0.001)., Conclusions: Patients undergoing LER for CLTI undergo more frequent reinterventions over time compared to patients treated for claudication. Research on reinterventions after LER should include reporting of the frequency of reintervention adjusted for the follow up period in addition to the reintervention rate defined as the percentage of patients undergoing reintervention., (Published by Elsevier Inc.)

Background: Acute lower limb ischemia (ALI) is a limb and life-threatening condition whose treatment largely depends on the underlying cause. The clinical distinction between the main causes may have changed over the years because of changes in the epidemiology of this syndrome. The objective of this study was to determine the clinical pattern associated with the main causes of ALI in a contemporary series of cases., Methods: We retrospectively reviewed all consecutive ALI cases admitted to a tertiary hospital between 2007 and 2019. ALI secondary to other conditions than embolism or NAT were excluded. The association between clinical variables and the ALI cause was assessed with multiple logistic regressions and the discriminative power of the resulting clinical predictive scores with the area under the ROC curve., Results: The study group included 243 patients (mean age 77.2 years; 52.7% male), of which 140 (57.6%) were caused by an arterial embolism and 103 (42.4%) by a NAT. Among these latter, 78 (75.7%) were related to an atherosclerotic NAT and 25 (24.3%) to a complicated popliteal aneurysm. Independent risk factors associated with embolism included atrial fibrillation (OR 10.26, 95% CI 5.1 - 20.67) or female gender (OR 5.44, 95% CI 2.76 - 10.71), but not the severity of the episode or the presence of contralateral pulses. Those related to a NAT included a previous symptomatic peripheral arterial disease (OR 2.68, 95% CI 1.35 - 5.35) and seeking consultation more than 24 hours after the beginning of symptoms (OR 2.57, 95% CI 1.32 - 5), but not a higher rate of other vascular risk factors. Among patients with NAT, previous intermittent claudication (OR 8.34, 95% CI 2.42 - 28.72) and >24 hs delay of arrival of the patient (OR 4.78, 95% CI 1.48 - 15.43) were more frequent among those related to an atherosclerotic NAT, whereas higher hemoglobin levels (OR 1.60, 95% CI 1.21 - 2.11) and non-significantly the history of tobacco smoking (OR 2.95, 95% CI 0.84 - 10.36) among those with a popliteal aneurysm-related NAT. The discriminative power of the two clinical models resulting from these predictive variables for differentiating embolism from NAT and atherosclerosis-related NAT from popliteal aneurysm-related NAT was excellent (0.86 and 0.85, respectively)., Conclusion: Certain clinical features appear to be no longer useful in the distinction between embolism and NAT, while others may help in the differential diagnosis between atherosclerotic and popliteal aneurysm-related NAT. Surgeons must be aware of possible changes in the presentation of ALI because time constraints are frequent and clinical data remain essential., (Copyright © 2021. Published by Elsevier Inc.)

Aim: Immune activation is strongly implicated in atherosclerotic plaque instability, however, the effect of immunosuppressant drugs on cardiovascular events in patients with peripheral artery disease (PAD) is not known. The aim of this study was to assess whether prescription of one or more immune suppressant drugs was associated with a lower risk of major adverse cardiovascular (MACE; i.e. myocardial infarction, stroke or cardiovascular events) or limb events (MALE; i.e. major amputation or requirement for peripheral revascularization) in patients with PAD., Methods: A total of 1506 participants with intermittent claudication (n = 872) or chronic limb threatening ischemia (CLTI; n = 634) of whom 53 (3.5%) were prescribed one or more immunosuppressant drugs (prednisolone 41; methotrexate 17; leflunomide 5; hydroxychloroquine 3; azathioprine 2; tocilizumab 2; mycophenolate 1; sulfasalazine 1; adalimumab 1) were recruited from 3 Australian hospitals. Participants were followed for a median of 3.9 (inter-quartile range 1.2, 7.3) years. The association of immunosuppressant drug prescription with MACE or MALE was examined using Cox proportional hazard analyses., Results: After adjusting for other risk factors, prescription of an immunosuppressant drug was associated with a significantly greater risk of MACE (Hazard ratio, HR, 1.83, 95% confidence intervals, CI, 1.11, 3.01; P = 0.017) but not MALE (HR 1.32, 95% CI 0.90, 1.92; P = 0.153). In a sub-analysis restricted to participants with CLTI findings were similar: MACE (HR 2.44, 95% CI 1.32, 4.51; P = 0.005); MALE (HR 1.38, 95% CI 0.87, 2.19; P = 0.175); major amputation (HR 1.37, 95% CI 0.49, 3.86; P = 0.547)., Conclusions: This cohort study suggested that immunosuppressant drug therapy is associated with a greater risk of MACE amongst patients with PAD., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The obesity paradox is a well-documented phenomenon in cardiovascular disease, however it remains poorly understood. We aimed to investigate the relationship between body mass (as measured by body mass index [BMI]) and 1-year amputation-free survival (AFS) for patients undergoing lower limb revascularisation for chronic limb-threatening ischaemia (CLTI)., Methods: A retrospective analysis was undertaken of all consecutive patients undergoing lower limb revascularisation for CLTI at the Leicester Vascular Institute between February 2018-19. Baseline demographics and outcomes were collected using electronic records. BMI was stratified using the World Health Organization criteria. One-year AFS (composite of major amputation/death) was the primary outcome. Kaplan-Meier survival analysis and adjusted Cox's proportional hazard models were used to compare groups to patients of normal mass., Results: One-hundred and ninety patients were included. Overall, no difference was identified in 1-year AFS across all groups (pooled P = 0.335). Compared to patients with normal BMI (n = 66), obese patients (n = 43) had a significantly lower adjusted combined risk of amputation/death (aHR 0.39, 95% CI 0.16-0.92, P = 0.032), however no significant differences were observed for overweight (aHR 0.89, 95% CI 0.47-1.70, P = 0.741), morbidly obese (aHR 1.15, 95% CI 0.41-3.20, P = 0.797) and underweight individuals (aHR 1.86, 95% CI 0.56-6.20, P = 0.314)., Conclusions: In the context of CLTI, obesity is potentially associated with favourable amputation-free survival at 1 year, compared to normal body mass. The results of this study support the notion of an obesity paradox existing within CLTI and question whether current guidance on weight management requires a more patient-specific approach., Competing Interests: Declaration of Competing Interest Nil, (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Arterial stiffness indices predict cardiovascular outcomes in patients with coronary or kidney disease; however, there is little data on the prognostic value of arterial stiffness in patients with advanced peripheral arterial disease. We determined whether arterial stiffness indices predict the outcomes of major amputation or death in patients with chronic limb-threatening ischemia (CLTI)., Methods: Arterial stiffness was prospectively measured using brachial oscillometry in patients with CLTI. After measuring arterial stiffness, patients were followed in 6-month intervals for up to 3 years and evaluated for limb preservation, occurrence of major amputation, or death. Hemodynamic variables and arterial stiffness indices were used to define predictors of amputation or death., Results: A total of 136 patients presented with CLTI, and 134 (99%) of these patients required limb revascularization. At the end of follow-up (mean, 14 months), 24 patients (18%) were alive with a major amputation, and mortality was 7% (9 patients); 33 patients (24%) progressed to the combined outcome of major amputation or death. Patients having amputation and/or death (n = 33; 24%) initially presented with elevated pulse wave velocity (PWV) (13.41 ± 1.21 m/s vs 11.54 ± 1.65 m/s; P < .001), elevated augmentation index corrected to 75 beats per minute (40.42 ± 6.65% vs 27.12 ± 9.19%; P < .001), and high augmentation pressure (AP) (29.98 ± 4.32 mm Hg vs 13.40 ± 7.05 mm Hg; P < .001) compared with patients with preserved limbs. The initial ankle-brachial index (ABI) was lower in patients having amputation and/or death (0.43 ± 0.94 vs 0.62 ± 0.12; P < .001). Multivariable analysis identified PWV (odds ratio [OR], 2.62; P = .013), AP (OR, 1.56; P < .001), and ABI (OR, 0.01; P < .001) as predictors of amputation or death. ROC analysis identified patients with PWV ≤12.7 m/s (hazard ratio, 4.71; P < .001), AP ≤22.15 mm Hg (hazard ratio, 13.03; P < .001), or ABI >0.52 with an increased rate of limb preservation., Conclusions: PWV and AP, measurements of arterial stiffness, as well as the ABI, predict amputation or death in patients with CLTI., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Calls for minimum case thresholds to guide surgeon credentialing paradigms are increasing in contemporary practice. To date, the volume-outcome relationship and the role of surgeon experience as a proxy for quality have remained primarily focused on nonvascular extirpative surgery and aneurysm repair. However, it is unclear whether these data can be rightly extrapolated to predict lower extremity bypass (LEB) outcomes. Thus, the purpose of the present study was to examine whether the annualized case volume vs surgeon experience is more consequential in predicting for successful LEB reconstruction., Methods: A total of 25,852 procedures with sufficient 1-year follow-up data from the Society for Vascular Surgery Vascular Quality Initiative infrainguinal bypass registry (2003-2019) were reviewed for chronic limb threatening ischemia among patients undergoing infrageniculate reconstruction. The procedures were categorized according to surgeon years of practice experience at surgery (ie, 0-5, 6-10, 11-15, >15 years) and the number of LEB procedures performed by the surgeon during the year of surgery (volume quartiles: 1-8, 9-14, 15-21, and >21). Mixed effects logistic and Cox regression models were used to assess the effects of experience, volume, and their interaction on outcomes., Results: Increasing practice experience was more significantly associated with a reduction of in-hospital complications (odds ratio, 0.97; 95% confidence interval [CI], 0.96-0.99; P = .002) and the risk of major adverse limb events (odds ratio, 0.94; 95% CI, 0.92-0.97; P < .0001) compared with the volume. Increasing experience and volume were both associated with increased freedom from thrombosis (hazard ratio, 0.95; 95% CI, 0.93-0.98; P = .001). In contrast, neither experience nor volume had any significant association with early mortality. However, a higher volume was associated with diminished long-term survival (hazard ratio, 1.04; 95% CI, 1.0-1.1; P = .01). The most experienced surgeons (>15 years' experience) were significantly more likely to perform LEB for rest pain (P < .0001). No significant differences were found in the bypass rates among patients with tissue loss. The most experienced and highest volume surgeons were more likely to use an autogenous and/or composite conduit, in situ reconstruction, and/or pedal targets (P < .05). Similarly, more experienced and higher volume surgeons had less blood loss and shorter procedure times (P < .0001). Overall, the most experienced surgeons (>15 years' experience) were significantly more likely to have a higher volume with a diminished risk for all LEB outcomes., Conclusions: Surgeon experience appears to have the most important role in predicting for overall LEB performance with improved in-hospital outcomes and major adverse limb events. The more experienced surgeons performed more complex reconstructions with fewer complications. These findings have significant clinical and educational implications as our most experienced surgeons approach retirement. Mentorship strategies to facilitate ongoing technical development among less experienced surgeons are imperative to sustain optimal limb salvage outcomes and have significant ramifications regarding expectations for regulatory and credentialing paradigms., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Inflammation is a component in the pathogenesis of critical limb ischemia. We aimed to assess how inflammation affects response to treatment in patients treated for critical limb ischemia using neutrophil-to-lymphocyte (NLR) and platelet-to-lymphocytes ratios (PLR) as markers of inflammation., Methods: Patients in a single tertiary cardiovascular center with critical limb ischemia unsuitable for surgical or interventional revascularization were retrospectively identified. Data were collected on medical history for risk factors, previous surgical or endovascular revascularization, and outcome. A standard regimen of low molecular weight heparin, aspirin, statins, iloprost infusions, and a standard pain medication protocol were applied to each patient per hospital protocol. Patients with improvement in ischemic pain and healed ulcers made up the responders group and cases with no worsening pain or ulcer size or progression to minor or major amputations made up the non-responders group. Responders and Non-responders were compared for risk factors including pretreatment NLR and PLR., Results: 268 included patients who were not candidates for surgical or endovascular revascularization were identified. Responders had significantly lower pretreatment NLR (4.48 vs 8.47, p < 0.001) and PLR (162.19 vs 225.43, p = 0.001) values. After controlling for associated risk factors NLR ≥ 4.63 (p < 0.001) and PLR ≥ 151.24 (p = 0.016) were independently associated with no response to treatment., Conclusions: Neutrophil-to-lymphocyte ratio and platelet-to-lymphocytes ratio are markers of inflammation that are reduced in patients improving with medical treatment suggesting a decreased state of inflammation before treatment in responding patients.

Objective: Skin perfusion pressure (SPP) has been proposed as a method to predict wound healing in chronic limb threatening ischaemia (CLTI). However, studies regarding the impact of SPP before and after endovascular therapy (EVT) on wound healing are limited. This study sought to evaluate the predictive value of SPP for early wound healing in CLTI treated by EVT., Methods: Between January 2018 and June 2020, 236 limbs (172 patients) with CLTI that underwent SPP measurement before and after EVT were included. SPP was measured before and 24 - 48 hours after the procedure. Early wound healing was defined as the achievement of complete epithelisation of all wounds without major amputation within three months of EVT., Results: Early wound healing was achieved in 145 (61.4%) limbs after EVT. Baseline SPP (44.1 ± 21.0 mmHg vs. 33.5 ± 21.7 mmHg; p < .001) and post-procedural SPP (61.8 ± 18.5 mmHg vs. 37.4 ± 19.9 mmHg; p < .001) were significantly higher in the wound healing (+) group than in the wound non-healing (-) group. The area under the receiver operating characteristics curve for early wound healing was 0.82 for post-procedural SPP with a cutoff value of 50 mmHg (sensitivity 74.5%, specificity 78.0%). The early wound healing rate was significantly higher with a post-procedural SPP ≥ 50 mmHg compared with a SPP < 50 mmHg (84.4% vs. 35.0%; p < .001)., Conclusion: Post-procedural SPP with a cutoff value of 50 mmHg was capable of predicting early wound healing after EVT in CLTI., (Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background Ankle-brachial index (ABI) is used to identify lower-extremity peripheral artery disease (PAD). However, its association with severe ischemic leg outcomes (eg, amputation) has not been investigated in the general population. Methods and Results Among 13 735 ARIC (Atherosclerosis Risk in Communities) study participants without clinical manifestations of PAD (mean age, 54 [SD, 5.8] years; 44.4% men; and 73.6% White) at baseline (1987-1989), we quantified the prospective association between ABI and subsequent severe ischemic leg outcomes, critical limb ischemia (PAD with rest pain or tissue loss) and ischemic leg amputation (PAD requiring amputation) according to discharge diagnosis. Over a median follow-up of ≈28 years, there were 221 and 129 events of critical limb ischemia and ischemic leg amputation, respectively. After adjusting for demographics, ABI ≤0.90 versus 1.11 to 1.20 had a ≈4-fold higher risk of critical limb ischemia and ischemic leg amputation (hazard ratios, 3.85 [95% CI, 2.09-7.11] and 4.39 [95% CI, 2.08-9.27]). The magnitude of the association was modestly attenuated after multivariable adjustment (hazard ratios, 2.44 [95% CI, 1.29-4.61] and 2.72 [95% CI, 1.25-5.91], respectively). ABI 0.91 to 1.00 and 1.01 to 1.10 were also associated with these severe leg outcomes, with hazard ratios ranging from 1.7 to 2.0 after accounting for potential clinical and demographic confounders. The associations were largely consistent across various subgroups. Conclusions In a middle-aged community-based cohort, lower ABI was independently and robustly associated with increased risk of severe ischemic leg outcomes. Our results further support ABI ≤0.90 as a threshold diagnosing PAD and also suggest the importance of recognizing the prognostic value of ABI 0.91 to 1.10 for limb prognosis.

Objectives: Acute limb ischemia (ALI) is a surgical emergency that generally develops in the outpatient setting. Hospitalized patients are also at risk for acute limb ischemia, but their presentation may be atypical or altered by medical therapy. Our institution developed an alert system to facilitate the prompt recognition and treatment of ALI that occurs in the inpatient population. We aimed to evaluate the usage of the system after the first 2 years of operation., Methods: All ALI alerts from October 2017 to December 2019 were collected from paging records and analyzed for location, timing, and the need for intervention. Alerts undergoing vascular intervention were classified as urgent (within 8 hours) or delayed (after 8 hr). Time and location data were evaluated to determine patterns of usage and true-positive rate of the system., Results: From October 2017 to December 2019, there were 237 ALI alerts obtained from paging records containing time and location information for the alert. More alerts originated from ICUs relative to non-ICU floors (68% vs. 33%, P< 0.001), however a greater proportion of non-ICU floor alerts required intervention compared to ICU alerts (32.0% vs. 5.1%, P < .0001). The highest number of ALI alerts were from the Medical ICU (MRICU) (45.9%) and medical/surgical floors (33.3%), followed by Surgical ICU (20.2%). Alerts were more common within 3 hr of morning and evening nursing shift changes (47.3%, P < 0.001). From the 237 total alerts, the patient was able to be identified retrospectively in 186 cases, and of these 27 resulted in operative interventions (14.5%, positive predictive value), with 11 patients (40.7%) requiring urgent intervention with a median time to intervention of 3.5 hr (range 2.2-4.8), and 16 (59%) alerts undergoing a delayed intervention at a mean of 3 days (range 2-4). A total of 73 (39.2%) alert patients died during their admission, of which 65 (89.0%) were in an ICU, and no deaths were directly related to ALI. The median time to death was 2 days (range 0-95 days), and in 22 cases death occurred <24 hr from time of alert., Conclusion: Our novel hospital-wide ALI alert system demonstrates a 14.5% positive predictive value for ischemia that resulted in an intervention. Alerts were more likely to originate from the ICU setting and during nursing shift changes. Alerts originating from non-ICU floors were 5 times more likely to undergo surgical intervention for ALI. Further analysis is required to assess the effect of this system on patient safety, outcome, and allocation of institutional resources., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX., Methods: We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX., Results: Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR., Conclusions: In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The optimal antiplatelet regimen after lower extremity revascularization in patients with chronic limb-threatening ischemia (CLTI) is unknown because current recommendations are based on extrapolation of data from trials in coronary artery disease and stroke., Methods: We identified all patients undergoing an elective lower extremity revascularization for CLTI in the Vascular Quality Initiative registry discharged on a mono antiplatelet agent (MAPT) or dual antiplatelet therapy (DAPT)., Results: From 2003 to 2018, 50,890 patients underwent revascularization procedures for CLTI, and were discharged on MAPT or DAPT. Of these, 33,781 patients underwent endovascular therapy (EVT), and 17,109 patients underwent open surgery (OS) procedures. The rate of major amputation at 30 days in the target limb in the EVT group was 0.3% and 0.4% in the OS group (P = .22). On Kaplan-Meier analyses, patients on MAPT at discharge had a higher risk of 1-year major amputation compared with DAPT after EVT but not after OS procedures. Patients on MAPT had lower overall survival and amputation-free survival at 30 days and 1 year compared with DAPT after both EVT and OS. At 1 year, the MAPT group was at higher risk for target lesion reintervention after EVT compared with the DAPT group (15.9% vs 13%; P = .0012). There was no significant difference in thrombosis at 1 year between the MAPT and DAPT groups either after EVT (3.9% vs 3.7%; P = .3048) or OS (3.1% vs 3.2%; P = .2893). On Cox regression analysis, DAPT was associated with improved survival but not major amputation after both EVT and OS., Conclusions: In patients with CLTI, DAPT at the time of discharge has a positive impact on amputation-free survival and overall survival after both EVT and OS as well as target lesion reintervention after EVT. DAPT was not associated with a positive impact on major amputation after either EVT or OS., (Published by Elsevier Inc.)

Background: Patients with critical limb-threatening ischemia (CLTI) have had poor long-term survival after lower extremity revascularization owing to coexistent coronary artery disease. A new cardiac diagnostic test, coronary computed tomography-derived fractional flow reserve (FFR CT ), can identify patients with ischemia-producing coronary stenosis who might benefit from coronary revascularization. We sought to determine whether the diagnosis of silent coronary ischemia before limb salvage surgery with selective postoperative coronary revascularization can reduce the incidence of adverse cardiac events and improve the survival of patients with CLTI compared with standard care., Methods: Patients with CLTI and no cardiac history or symptoms who had undergone preoperative testing to detect silent coronary ischemia with selective postoperative coronary revascularization (group I) were compared with patients with standard preoperative cardiac clearance and no elective postoperative coronary revascularization (group II). Both groups received guideline-directed medical care. Lesion-specific coronary ischemia in group I was defined as FFR CT of ≤0.80 distal to a stenosis, with severe ischemia defined as FFR CT of ≤0.75. The endpoints included all-cause death, cardiovascular (CV) death, myocardial infarction (MI), major adverse CV events (i.MACE; CV death, MI, unplanned coronary revascularization, stroke) through 2 years of follow-up., Results: Groups I (n = 111) and II (n = 120) were similar in age (66 ± 9 vs 66 ± 7 years), gender (78% vs 83% men), comorbidities, and surgery performed. In group I, unsuspected, silent coronary ischemia was found in 71 of 103 patients (69%), with severe ischemia in 58% and left main coronary ischemia in 8%. Elective postoperative coronary revascularization was performed in 47 of 71 patients with silent ischemia (66%). In group II, the status of silent coronary ischemia was unknown. The median follow-up was >2 years for both groups. The 2-year outcomes for groups I and II were as follows: all-cause death, 8.1% and 20.0% (hazard ratio [HR], 0.38; 95% confidence interval [CI], 0.18-0.84; P = .016); CV death, 4.5% and 13.3% (HR, 0.32; 95% CI, 0.11-0.88; P = .028); MI, 6.3% and 17.5% (HR, 0.33; 95% CI, 0.14-0.79; P = .012); and major adverse CV events, 10.8% and 23.3% (HR, 0.44; 95% CI, 0.22-0.88; P = .021), respectively., Conclusions: The preoperative evaluation of patients with CLTI and no known coronary artery disease using coronary FFR CT revealed silent coronary ischemia in two of every three patients. Selective coronary revascularization of patients with silent coronary ischemia after recovery from limb salvage surgery resulted in fewer CV deaths and MIs and improved 2-year survival compared with patients with CLTI who had received standard cardiac evaluation and care. Prospective controlled studies are required to further define the role of FFR CT in the evaluation and treatment of patients with CLTI., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The Global Vascular Guidelines (GVG) propose a novel Global Anatomic Staging System (GLASS) with the Wound, Ischemia, and foot Infection (WIfI) classification system as a clinical decision-making tool for interventions in chronic limb-threatening ischemia (CLTI). We assessed the validity of clinical staging and the relationship between the treatments recommended by the GVG and the outcomes of the actual procedures., Methods: This retrospective, single-center, observational study included 117 patients with CLTI undergoing infrainguinal revascularization in our hospital between 2015 and 2019. Of those patients, 55 underwent open bypass (OB) and 62 underwent endovascular revascularization (EVR). Femoropopliteal, infrapopliteal, and inframalleolar GLASS grades were assigned based on angiographic images. These grades were combined to determine the revascularization strategy recommended by the GVG: "endovascular," "indeterminate," and "open bypass." The indeterminate category includes three subcategories: GLASS stage III, WIfI stage 2; GLASS stage II, WIfI stage 3; and GLASS stage II, WIfI stage 4. For the purposes of this study, we labeled these subcategories A, B, and C, respectively. The primary outcome was the correlation between the revascularization strategies recommended by the GVG and the actual procedures performed. The relationships between the actual procedures and overall survival, limb salvage, and patency were also examined., Results: The femoropopliteal and infrapopliteal GLASS grades were higher in the OB group. EVR was performed more often for GLASS stages I and II and was more often classified as indeterminate B and C, whereas OB was performed more often in GLASS stage III and was more often classified as indeterminate A. There were no statistically significant differences in the inframalleolar/pedal disease descriptor or in the 30-day postoperative complication rates between the two groups. In higher GLASS stages, the technical success rate of EVR was lower, and lesion complexity was more severe. Patients for whom the recommended strategy according to the GVG would have been OB but who underwent EVR were associated with low limb salvage and patency rates., Conclusions: The GVG provide good guidance for the selection of the revascularization strategy. When the GVG indicate OB, it should be the treatment of choice, rather than EVR, for patients who are fit to undergo the procedure., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The aim of this study was to evaluate changes in transcutaneous oxygen pressure (tcpO 2 ) and systolic toe pressure (TP) during endovascular intervention., Methods: This was a single centre prospective, non-randomised, observational feasibility study. Patients with chronic limb threatening ischaemia (CLTI) due to infrainguinal disease scheduled for endovascular treatment were included between March 2018 and December 2019. TcpO 2 was measured continuously bilaterally at foot level throughout the procedure and at follow up. Specific time points during the intervention were chosen for comparison to baseline (before arterial puncture): average tcpO 2 level five minutes prior to percutaneous transluminal angioplasty (PTA); 10 minutes after PTA; and at completion. Bilateral TP was recorded using laser Doppler flowmetry before arterial puncture, at completion, and at clinical follow up. Angiograms were analysed for successful revascularisation and vascular lesions classified according to the Global Limb Anatomical Scoring System (GLASS). Rutherford and WIfI (Wound, Ischaemia, and foot Infection) classifications were registered, as well as clinical outcome., Results: Twenty-one patients completed the study. Completion angiograms showed inline flow to the foot in all but two patients. Median time to follow up was 10 weeks (range 8 - 13 weeks) and all patients except one improved clinically. TcpO 2 decreased during the initial stage of the intervention, from before arterial puncture to five minute average before PTA (p < .001) and did not recover to above baseline values at the end of intervention. TcpO 2 increased significantly at follow up (p < .001). TP increased statistically significantly during intervention (p < .001) and at follow up (p < .001) compared with baseline., Conclusion: TcpO 2 and TP measurements are safe and feasible non-invasive techniques for haemodynamic monitoring during endovascular revascularisation. TP increased significantly immediately after completion of the successful intervention, whereas tcpO 2 did not. Both TP and tcpO 2 demonstrated a significant increase at the 10 week follow up., (Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: Advanced peripheral arterial disease is associated with an overall annual mortality between 20-40%. Amputees are at particularly high risk for perioperative and long-term mortality and may benefit from palliative care programs to improve quality of life and to align medical treatments with their goals of care. As studies of palliative care in vascular patients are scarce, we sought to examine palliative care utilization using below knee amputation (BKA) as a surrogate for advanced peripheral arterial disease., Methods: All patients who underwent below knee amputation over a 5-year period at a single large academic medical center were identified through chart review. Demographics, preoperative conditions, intraoperative factors, and perioperative outcomes were recorded. The primary outcome was palliative care consultation at the time of the amputation. The secondary outcomes included one-year mortality and palliative care consultation prior to death., Results: The cohort comprised 111 patients (76 men, 35 women) who received BKA for chronic limb threatening ischemia. Three patients (2.7%) received palliative care consultations at the time of their amputation. Of these, one had been obtained remotely for an oncologic condition and the others for surgical decision-making. Follow-up was available for 73 patients. One-year mortality was 21.9% (n = 16) at a mean of 102 ± 86 days after BKA. Among patients who died within 1 year of their amputation, 37.5% (n = 6) received palliative care consultations prior to their death. The median interval between amputation and palliative consultation was 26 (IQR 14-81) days. The median interval between palliative consultation and death was 9 (IQR 4-39) days., Conclusion: Palliative care services were rarely provided to patients with advanced peripheral arterial disease. When obtained, consultations occurred closer to death than to amputation suggesting a missed opportunity to receive the benefits of early evaluation. Future studies can be aimed at identifying a cohort of vascular patients who would most benefit from early palliative evaluation and determining if palliative consultations alter health care utilization patterns and outcomes for vascular patients., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Investigate the relationship of frailty and severity of chronic limb-threatening ischaemia (CLTI), and their comparative associations with one-year outcomes, in patients presenting to a vascular limb salvage (VaLS) clinic., Methods: This retrospective cohort study utilised data collected from a prospectively maintained VaLS clinic database. Patients aged ≥50 presenting to the VaLS clinic with CLTI between February 2018 and April 2019 were included. Frailty was measured using the Clinical Frailty Scale (CFS) and limb threat severity by the Wound, Ischaemia, and foot Infection (WIfI) score. Excessive polypharmacy was defined as ≥10 medications. Anticholinergic burden (ACB) score and Charlson comorbidity index (CCI) were calculated for all patients. The primary outcome measure was a composite endpoint of death or amputation at one-year. Associations with outcome were assessed using Cox regression and reported as hazards ratios (HR) with 95% confidence intervals (CI)., Results: A total of 198 patients were included, with CFS scores available for 190 patients. 98 patients (52%) were frail (CFS ≥5). 127 patients (67%) initially underwent endovascular revascularisation. Excessive polypharmacy was common (55 patients; 28%). Frailty was associated with increased WIfI stage (P = 0.025) as well as age, female sex, CCI score, number of medications, excessive polypharmacy but not ACB score. Frail patients were more frequently managed non-operatively (P = 0.017). Frailty (HR 1.91; 95% CI 1.09, 3.34; P = 0.024) and WIfI stage 4 (HR 3.29; 95%CI 1.23, 8.80; P = 0.018) were associated with death or amputation on univariable analysis. WIfI stage 4 (HR 2.80; 95%CI 1.04, 7.57; P = 0.042) and CCI score (HR 1.21; 95%CI 1.03, 1.41; P = 0.015), but not frailty (HR 1.25; 95%CI 0.67, 2.33; P = 0.474), were independently associated with death or amputation on multivariable analysis., Conclusions: Frailty is highly prevalent among CLTI patients and related to severity of limb threat. The CFS may be a useful adjunct to patient risk assessment in CLTI., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD., Methods: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis., Results: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication., Conclusions: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: There is an increasing incidence of peripheral arterial disease (PAD). The most common symptomatic presentation of PAD is intermittent claudication (IC), reproducible leg pain with ambulation. The progression of symptoms beyond IC is rare, and a nonprocedural approach of smoking cessation, supervised exercise therapy, and best medical therapy can mitigate progression of IC. Despite the lack of limb- or life-threatening sequelae of IC, invasive treatment strategies of IC have experienced rapid growth. Within our health care system, PAD is treated by multiple disciplines with varying practice patterns, providing an opportunity to investigate the progression of IC based on treatment strategy. This study aims to compare PAD progression and amputation in patients with IC with and without revascularization., Methods: This institutional review board-approved, single institute retrospective study reviewed all patients with an initial diagnosis of IC between June 11, 2003, and April 24, 2019. Revascularization was defined as endovascular or open. Time to chronic limb-threatening ischemia (CLTI) diagnosis and amputation were stratified by revascularization status using the Kaplan-Meier method. The association between revascularization status and each of CLTI progression and amputation using multivariable Cox regression, adjusting for demographic and clinical potential confounding variables was assessed., Results: We identified 1051 patients who met the inclusion criteria. Of these patients, 328 had at least one revascularization procedure and 723 did not. The revascularized group was younger than the nonrevascularized group (60.3 years vs 62.1 years; P = .013). There was no significant difference in sex or comorbidities in the two groups other than a higher rate of diabetes mellitus type 2 (32.3% vs 16.3%; P < .001) and COPD (4.3% vs 1.7%; P = .017) in the revascularized group. Multivariable Cox regression found revascularization of patients with IC to be significantly associated with the progression to CLTI (hazard ratio, 2.9; 95% confidence interval, 2.0-4.2) and amputation (hazard ratio, 4.5; 95% confidence interval, 2.2-9.5). These findings were also demonstrated in propensity-matched cohorts of 218 revascularized and 340 nonrevascularized patients., Conclusions: Revascularization of patients with IC is associated with an increased rate of progression to CLTI and increased amputation rates. Given these findings, further studies are required to identify which, if any, patients with IC benefit from revascularization procedures., (Published by Elsevier Inc.)

Objectives: Among changes in demographics, aging is the most relevant cardiovascular risk factor. The prevalence of peripheral artery disease (PAD) is high in elderly patients and is associated with a worse prognosis. Despite optimal treatments, mortality in the high-risk population of octo- and nonagenarians with PAD remains excessive, and predictive factors need to be identified. The objective of this study was to investigate predictors of mortality in octo- and nonagenarians with PAD., Methods: Cases of treated octo- and nonagenarians, including the clinical characteristics and markers of myocardial injury and heart failure, were studied retrospectively with respect to all-cause mortality. Hazard ratios [HR] were calculated and survival was analyzed by Kaplan-Meyer curves and receiver operating characteristic curved were assessed for troponin-ultra and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and chronic limb-threatening ischemia (CLTI)., Results: A total of 123 octo- and nonagenarians admitted for PAD were eligible. The troponin level was the major predictor of all-cause mortality (HR: 4.6, 95% confidence interval [CI]: 1.4-15.3), followed by the NT-proBNP level (HR: 3.9, 95% CI 1.8-8.8) and CLTI (HR: 3.1, 95% CI 1.6-5.9). Multivariate regression revealed that each increment of 1 standard deviation in log troponin and log NT-proBNP was associated with a 2.7-fold (95% CI 1.8-4.1) and a 1.9-fold (95% CI 1.2-2.9) increased risk of all-cause death. Receiver operating characteristic curve analysis using a combination of all predictors yielded an improved area under the curve of 0.888. In a control group of an equal number of younger individuals, only NT-proBNP (HR: 4.2, 95% CI 1.2-14.1) and CLTI (HR: 6.1, 95% CI 1.6-23.4) were predictive of mortality., Conclusion: Our study demonstrates that cardiovascular biomarkers and CLTI are the primary predictors of increased mortality in elderly PAD patients. Further risk stratification through biomarkers in this high-risk population of octo- and nonagenarians with PAD is necessary., (© 2021. The Author(s).)

Objective: Despite prior literature recommending against limb salvage in patients with poor functional status such as nonambulatory patients with chronic limb-threatening ischemia (CLTI), peripheral endovascular interventions continue to be carried out in this group of patients. Clinical outcomes following these interventions are, however, not well-characterized., Methods: A retrospective review was conducted on all patients treated for CLTI in the Vascular Quality Initiative from September 2016 to December 2019. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression analyses were used as appropriate to study outcomes. The primary outcomes were 30-day mortality and 1-year amputation-free survival. The secondary outcomes were in-hospital death, postoperative complications, 1-year freedom from major amputation, and 2-year survival., Results: Of the 49,807 patients studied, 28,469 (57.2%) were ambulatory, 15,148 (31.0%) were ambulatory with assistance, 5395 (10.8%) were wheelchair bound, and 525 (1.1%) were bedridden. There was a 2-fold increase in the odds of 30-day death in patients who were ambulatory with assistance (odds ratio [OR], 2.03; 95% confidence interval [CI], 1.77-2.34; P < .001) and wheelchair-bound patients (OR, 2.09; 95% CI, 1.74-2.51; P < .001), and a more than 6-fold increase in bedridden patients (OR, 6.28; 95% CI, 4.55-8.65; P < .001) compared with ambulatory patients. There was a significantly higher odds of postoperative complications in patients who were ambulatory with assistance or bedridden, but no difference with wheelchair-bound patients. Among ambulatory patients, the risks of major amputation and death within 1 year were only 10% and 12%, respectively, whereas that of bedridden patients were as high as 30% and 38%, respectively. A stepwise decrease in amputation-free survival from 81% with full ambulatory capacity to less than 50% (47.7%) in bedridden patients was observed. The risk of major amputation or death within 1 year was 35% higher for ambulatory with assistance (hazard ratio [HR], 1.35; 95% CI, 1.26-1.44; P < .001), 65% higher for wheelchair-bound (HR, 1.65; 95% CI, 1.51-1.79; P < .001) and 2.6-fold higher for bedridden (HR, 2.64; 95% CI, 2.17-3.21; P < .001) compared with ambulatory. A similar association was seen for 1-year freedom from major amputation and 2-year survival., Conclusions: Ambulatory impairment in patients with CLTI is associated with a significant increase in 30-day mortality and significant decrease in amputation-free survival after peripheral endovascular intervention. Bedridden patients had a 6-fold increase in the 30-day death rate, whereas their amputation-free survival dropped to less than 50% at 1 year. These risks should be considered during shared decision-making regarding management options for nonambulatory patients with CLTI., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aims to examine the changes in anxiety and depression scores in 138 patients with critical limb ischemia (rest pain or gangrene) who had no previous psychiatric history, at 30 days and 6 months after surgical revascularization., Methods: Patients were submitted to a questionnaire-based evaluation using the Beck Anxiety and Depression Inventories before surgery (no more than three days before surgery) ("Pre-Op"), 30 days after surgical revascularization ("Early PO") and at least 6 months after surgical revascularization ("Late PO"). The cut-off scores for depression were (1) < 10, no depression or minimal depression; (2) 10‒18, mild to moderate depression; (3) 19‒29, moderate to severe depression; and (4) 30‒63, severe depression. The cut-off scores for anxiety were (1) < 8, no anxiety or minimal anxiety; (2) 8‒15, mild anxiety; (3) 16‒25, moderate anxiety; and (4) 26‒63, severe anxiety., Results: No perioperative mortality was observed 30 days after surgical revascularization. Thirty-nine (28.2%) patients underwent major (above-ankle) amputation within 30 days. Mean anxiety and depression scores, respectively, declined from 12.48 ± 9.74 (mean ± SD) and 16.92 ± 12.48 preoperatively to 4.89 ± 7.04 and 6.52 ± 9.36 postoperatively (P<0.001, both). Anxiety and depression scores were not significantly affected by preoperative comorbidities (systemic arterial hypertension, diabetes mellitus, previous stroke, and smoking), affected arterial territory (aortoiliac, femoropopliteal, or infrapopliteal), or surgical technique (open surgery vs endovascular therapy). Only patients undergoing amputation within 30 days showed no improvement in depressive symptoms., Conclusions: Patients with critical limb ischemia have a high incidence of anxiety and depressive symptoms, which improve considerably after successful surgical revascularization. Major amputation was associated with a lack of improvement in depression scores. A formal psychiatric evaluation may be beneficial in patients who show no improvement in depressive symptoms., (Copyright © 2021. Published by Elsevier Inc.)

Background: The ERICVA score was derived to predict amputation-free survival in patients with critical limb ischemia (CLI). It may be a useful tool to stratify patients in trials of novel interventions to treat CLI but, as yet, it has not been externally validated., Methods: A prospective database of CLI patients was developed during prescreening of patients for a phase 1 stem cell therapy clinical trial. The primary outcome was amputation free survival (AFS) at 1 year. Both the full ERICVA scale (11 parameters) and simplified ERICVA scale (5 parameters) were validated. Data analysis was performed by calculation of the area under the receiver operating characteristic (ROC) curve examining the predictive value of the scores. The Chi-square test was used to examine the association between risk group and one-year AFS and the cumulative survival of the three risk groups was compared using Kaplan Meier survival curves., Results: A series of 179 CLI patients were included in the analysis. The Chi-square test of independence showed a significant association between the risk group (high, medium and low) and one-year AFS outcome (P = 0.0007). Kaplan-Meier survival curve showed significant difference in one-year AFS between the three risk groups (log-rank P < 0.001). The area under the curve (AUC) was found to be 0.63 and 0.61 for the full and simplified score, respectively. The sensitivity of the full score was 0.44 with specificity of 0.84. The simplified score had a sensitivity of 0.28 and specificity of 0.92., Conclusion: The ERICVA risk score system was found to have a fair validity but cannot be considered reliable as a single predictor of one year AFS of CLI patients. The simplified score had an AUC almost identical to the full score and can accordingly replace the full score., (Copyright © 2021. Published by Elsevier Inc.)

Background: Recent guidelines raise the concept of the importance of health-related quality of life (QoL). Change in QoL after amputation in ischemic patients is not well described. We aim to evaluate the change in quality of life after major limb amputation in patients with peripheral arterial disease., Methods: We retrospectively identified all patients submitted to above-knee amputation (AKA) and below-knee amputation in our vascular surgery department in a 2-year period. Trauma excluded. A vascular amputee adapted QoL questionnaire was administered comparing the last 2 weeks to the 2 weeks before amputation. It included subjective and objective questions adapted from WHOQoL-BREEF and SF-36 divided into specific domains of QoL (physical health, role physical, pain, social, and psychological health) that were compared to 2 global items (overall QoL and general health). Independent samples tests and linear correlations were calculated., Results: A total of 106 patients were included, 30-day mortality rate 16.3% and 1-year 39.1%. Patients had an increase in mean total score after amputation of 14.35 out of 100 points, with an improvement of 52.1 points in pain and 11 points in social and psychological health out of 100 (P<0.001). Physical health and role physical scores decreased after amputation. Overall QoL was correlated with total score (P<0.001). Mean QoL total score after amputation was 79.0% ± 12.6. In general, amputees scored higher in the domains social and psychological health. Older people, women, AKA and bilateral amputees had lower physical health scores (P<0.05), prosthesis was correlated with improvement in physical health after amputation (P = 0.026). Elderly and married people had big improvement in overall QoL after amputation (P = 0.008 and P = 0.056, respectively)., Conclusions: QoL does not seem to diminish in advanced ischemic patients after amputation. Older people value more a decrease in pain and family support over physical health. Therefore, patient oriented treatments should be preferred. Future research should be made to validate a disease-specific questionnaire for this population., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: Data from 2011-2014 showed lower extremity bypass(LEB) outperforming infrainguinal endovascular intervention(IEI) regarding major adverse limb events(MALE) but noted no significant difference in major adverse cardiac events(MACE) in propensity matched cohorts. This study aimed to determine if more recent(2015-2018) endovascular outcomes data have improved relative to surgical bypass., Methods: Patients who underwent intervention for chronic limb threatening ischemia (CLTI) from 2015-2018 were identified using the American College of Surgeons National Quality Improvement Program(NSQIP) Vascular Surgery module. The cohort was categorized as undergoing lower extremity bypass(LEB) or infrainguinal endovascular intervention(IEI). Primary 30-day outcomes included major adverse cardiac events(MACE), major adverse limb events(MALE), and major amputation. Inverse probability weighting was used for multivariable analysis., Results: A total of 10,783 patients underwent an infrainguinal intervention for CLTI from 2015-2018. Of these, 6,003(55.7%) underwent LEB and 4,780(44.3%) underwent IEI. Forty percent of the cohort was considered "high anatomic risk" by Objective Performance Goals(OPG) standards, and 13.6% were considered "high clinical risk." The IEI cohort vs. the LEB cohort experienced a Myocardial infarction(MI)/Stroke rate of 1.8% vs. 3.6%(p < .001), and had a mortality rate of 2.0% vs. 1.7%(p = .22), which yielded a composite MACE of 3.4% vs. 4.8%(p = .001). The rate of reintervention for IEI vs LEB was 4.4% vs. 5.3%(p = .04), the loss of patency (without re-intervention) rate was 1.8% vs. 1.8%(p = 1.0), and the major amputation rate was 4.1% vs. 3.5%(p = .15), which resulted in a MALE rate of 9.1% vs. 8.8%(p = .50). Following inverse probability weighting, comparing the IEI to the referent LEB, MALE AOR = 1.17, 95% CI[1.01 -1.36], p = .036, MACE AOR = 0.61, 95% CI[0.49-0.74], p < .001, and major amputation AOR = 1.31, 95% CI[1.05 -1.62], p = .016., Conclusion: Endovascular outcomes continue to demonstrate inferiority in major amputation and overall MALE. However, endovascular intervention has a significantly reduced incidence of MACE. Overall, these results demonstrate an improvement in endovascular MACE rates in recent years relative to surgical bypass.

Background: Although often overlooked during the preoperative evaluation, recent evidence has suggested that depression in patients with peripheral artery disease is associated with increased postoperative complications, including decreased primary and secondary patency after revascularization and an increased risk of major amputation and mortality. Postoperative nonhome discharge (NHD) is an important outcome for patients and has also been associated with other adverse outcomes; however, the effect that depression has on NHD after vascular surgery has remained unexplored. We hypothesized that depression would be associated with an increased risk of NHD after revascularization for chronic limb threatening ischemia (CLTI)., Methods: Endovascular, open, and hybrid (combined open and endovascular) cases of revascularization for CLTI were identified from the 2012 to 2014 National (Nationwide) Inpatient Sample. CLTI, diagnoses of depression, and medical comorbidities were defined using the corresponding International Classification of Diseases, Ninth Revision, Clinical Modification codes. A hierarchical multivariable binary logistic regression controlling for hospital level variation and for confounders meeting P <.01 on bivariate analysis was used to examine the association between depression and NHD. A sensitivity analysis after coarsened exact matching for baseline characteristics that differed between the two groups was performed to reduce any imbalance., Results: A total of 64,817 cases were identified, of which 5472 (8.4%) included a diagnosis of depression and 16,524 (25.5%) NHD. The patients with depression were younger and more likely to be women and white, have multiple comorbidities and a nonelective admission, and experience a postoperative complication (P <.05). On unadjusted analyses, patients with depression had an 8% absolute increased risk of requiring NHD (32.1% vs 24.9%; P <.001). On multivariable analysis, patients with depression had an increased odds for NHD (odds ratio [OR], 1.50; 95% confidence interval [CI], 1.40-1.61; c-statistic, 0.81) compared with those without depression. After stratification by operative approach, depression had a larger effect estimate in endovascular revascularization (OR, 1.57; 95% CI, 1.42-1.74) compared with open (OR, 1.45; 95% CI, 1.30-1.62). A test for interaction between depression and gender identified that men with depression had greater odds of NHD compared with women with depression (OR, 1.68; 95% CI, 1.51-1.88; vs OR, 1.37; 95% CI, 1.25-1.51; interaction P <.01). A sensitivity analysis after coarsened exact matching confirmed these findings., Conclusions: To the best of our knowledge, the present study is the first to identify an association between depression and NHD after revascularization for CLTI. These results provide further evidence of the negative effects that comorbid depression has on patients undergoing revascularization for CLTI. Future studies should examine whether treating depression can improve the outcomes in this patient population., (Copyright © 2021 Society for Vascular Surgery. All rights reserved.)

Management of neuropathic pain in people with diabetes has been widely investigated. However, little attention was paid to address ischemic-related pain in patients with diabetes mellitus who suffered from chronic limb-threatening ischemia (CLTI), the end stage of lower extremity arterial disease (LEAD). Pain management has a tremendous influence on patients' quality of life and prognosis. Poor management of this type of pain owing to the lack of full understanding undermines patients' physical and mental quality of life, which often results in a grim prognosis, such as depression, myocardial infarction, lower limb amputation, and even mortality. In the present article, we review the current strategy in the pain management of diabetes-related CLTI. The endovascular therapy, pharmacological therapies, and other optional methods could be selected following comprehensive assessments to mitigate ischemic-related pain, in line with our current clinical practice. It is very important for clinicians and patients to strengthen the understanding and build intervention strategy in ischemic pain management and possible adverse consequence., Competing Interests: The authors declare no competing interests in this work., (Copyright © 2021 Xiaoyan Jiang et al.)

Background: Previous studies in patients with arterial claudication have focused on calf hemodynamic recovery. We hypothesized that the duration of hemodynamic recovery with TcpO2 at calf and non-calf levels would be shorter than 10 min. We analyzed the factors that influence the recovery time., Methods: We monitored limb changes minus chest changes from rest (DROP) of transcutaneous oximetry on buttocks, thighs and calves, during and following a treadmill test (3.2 km/h; 10% grade). We calculated the time required to reach 50% (50%RT) and 10% (90%RT) of minimal DROP value (DROPm) from walking cessation. Regression analyses were used to determine the factors associated to 50%RT and 90%RT., Results: Of the 132 patients studied, 18.2% reported isolated non-calf pain by history. Of the 792 recovery time values, only 3 (0.4%) and 23 (2.9%) were in excess of 10 min for 50%RT and for 90%RT, respectively. A weak correlation was found between each of the 792 DROPm and 50%RT (r = -0.270, p < 0.001) as well as for 90%RT (r = -0.311 p < 0.001). Lowest DROPm and BMI (but not age, sex, the use of beta-blockers, the duration of the walking period) were associated to both 50%RT and 90%RT., Conclusion: Although recovery duration correlates significantly with the severity of ischemia of the same location, a wide discrepancy exists and the longest recovery time does not always correlate to the localization of the most severe ischemia. Non-calf ischemia should be measured when one aims at objectifying the biological effects of exercise or the effects of treatments on recovery from exercise., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Frailty is a common, age-associated syndrome that has been used to predict postoperative outcomes in vascular surgery. This study examines if standard measures of frailty correlate with postoperative outcomes for patients undergoing revascularization for acute limb ischemia (ALI)., Methods: A retrospective study was conducted on all adult patients undergoing revascularization for ALI at an academic medical center between January 2016 and June 2019. Frailty was calculated with the 11-factor modified frailty index (mFI-11), derived from the Canadian Study of Health and Aging Frailty Index. Outcomes examined included in-hospital mortality, major amputation, site of discharge, and ambulatory status at follow-up., Results: Fifty-three ambulatory patients presented with ALI during the study time period, with 13.2% deemed not frail (mFI-11 < 3) and 86.8% deemed frail (mFI-11 ≥ 3). Frailty was significantly correlated with discharge to a skilled nursing facility (P = 0.028) and nonambulation at follow-up (P = 0.002). There was no significant correlation with other outcomes, including mortality and amputation. On multivariate analysis, frailty was the only factor contributing to nonambulation at follow-up (P = 0.012). Endovascular treatment did not mitigate the effects of frailty on discharge site and ambulatory status., Conclusions: Frailty is exceedingly common in patients with ALI. Although frailty predicts discharge site and nonambulation at follow-up, it is not associated with amputation or death. Therefore, frail patients should not be denied open or endovascular revascularization for ALI., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce., Methods: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 - 3. Safety and clinical success rate were collected at one month., Results: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 - 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 - 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively., Conclusion: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Aims: Infection in diabetic foot syndrome (DFS) represents serious medical problem, and the annual risk of DFS in diabetic patients is 2.5%. More than half of the patients with DFS have symptoms of extremity ischemia (peripheral arterial disease (PAD)). The aim of the present study was to analyze the frequency of particular bacterial strains in people with DFS, analyze the impact of arterial ischemia on the occurrence of a given pathogen, and evaluate the antibacterial treatment based on the results of bacterial culture., Methods: The analysis included 844 bacterial strains obtained from 291 patients with DFS hospitalized in the Department of Angiology in years 2016-2019., Results: The most common isolates were Staphylococcus aureus , Enterococcus faecalis , Enterobacter cloacae , Pseudomonas aeruginosa , and Acinetobacter baumannii . Nearly 20% of the species were found to have at least one resistance mechanism. In patients with PAD, Gram-negative species were isolated more commonly than in people without PAD. The most useful drugs in DFS in hospitalized patients are penicillins with beta-lactamase inhibitors, 3rd- to 5th-generation cephalosporins (with many exceptions), carbapenems, aminoglycosides, and tigecycline., Conclusions: Bacterial strains isolated from ischemic DFS are more resistant to commonly used antibacterial agents, i.e., penicillins (including penicillins with beta-lactamase inhibitors), cephalosporins (except for the 4 th and 5 th generations), glycopeptides, and linezolid. When planning treatment of hospitalized patients with DFS, the presence of ischemia in DFS should always be taken into consideration. It determines the occurrence of particular bacterial species and the choice of antibacterial agent and may determine the rate of treatment success., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2021 Rafał Małecki et al.)

Objective: Diabetes has been shown to be associated with increased risk of postoperative complications after lower extremity bypass (LEB), although it is unclear whether medium-term glucose control affects outcomes. This study aimed to assess the association of perioperative hemoglobin A 1c (HbA 1c ) level on perioperative outcomes after LEB., Methods: We examined consecutive infrainguinal LEBs for chronic limb-threatening ischemia (CLTI) using the Vascular Quality Initiative database (2007-2018). Perioperative HbA 1c levels were stratified into <5.7%, 5.7% to 6.5%, and >6.5%. Propensity score matching on demographics, medical history, and procedural characteristics was used to select comparable patients across HbA 1c groups. The primary outcome was postoperative wound infection. Multivariable analyses were performed for matched and unmatched groups using Cox proportional hazards models for survival outcomes and logistic regression for binary outcomes with association expressed by adjusted hazard ratio (aHR) or adjusted odds ratio (aOR) and corresponding 95% confidence intervals (CIs)., Results: The CLTI cohort included 8171 infrainguinal LEBs: 631 (7.7%) had HbA 1c  <5.7%; 1691 (20.6%), 5.7% to 6.5%; and 5849 (71.6%), >6.5%. There was no difference in rates of wound infection in the CLTI cohort (HbA 1c ≤5.7%, 3.8%; HbA 1c 5.7%-6.5%, 3.7%; HbA 1c >6.5%, 3.2%; P = .53) or matched cohort (4.3%, 4.5%, 3.4%; P = .62). There were no differences in perioperative mortality in the CLTI cohort (2.5%, 1.7%, 1.5%; P = .16) or the matched cohort (2.7%, 2.3%, 2.2%; P = .84). In multivariable analysis, there was no significant association between HbA 1c and wound infection in the CLTI cohort (HbA 1c 5.7%-6.5% vs <5.7%: aOR, 0.91 [95% CI, 0.56-1.50; P = .72]; HbA 1c >6.5% vs <5.7%: aOR, 0.81 [95% CI, 0.52-1.26; P = .35]). There was, however, a significant association between decreased HbA 1c and mortality (HbA 1c 5.7%-6.5% vs <5.7%: aHR, 0.77 [95% CI, 0.61-0.97; P = .03]; HbA 1c >6.5% vs <5.7%: aHR, 0.75 [95% CI, 0.61-0.93; P = .01])., Conclusions: Our study suggests no significant association of increased HbA 1c level and perioperative complications. Additional investigation is required to further evaluate the impact of short-term glycemic control and long-term outcomes of patients undergoing LEB., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Over the past decade, improvements in medical treatment and revascularization techniques have been beneficial for patients with peripheral artery disease in the late stage of critical limb ischemia (CLI). We evaluated the putative reduction in the number of major amputees in the Cohorte des Patients ARTeriopathes (COPART) cohort over time. Patients were selected from this multicenter cohort, from 2006 to 2016, for CLI according to Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease II criteria. Patients included before and after 2011 were compared. Patients were followed for 1 year. Primary outcome was the rate of major amputations. Secondary outcomes were minor amputations, deaths from all causes, cardiovascular deaths; 989 patients were included, 489 before 2011 and 450 after 2011. There was a significant decrease in rates of major amputation after 2011 (17% vs 25%), confirmed in multivariate analysis (odds ratio [OR]: 1.5 [1.1-2.2]), an increase in revascularization, particularly distal angioplasty (OR: 2.7 [1.7-4.4]) and increased statin intake (OR: 1.6 [1.1-2.1]). For secondary outcomes, there was no significant difference. Limb prognosis of CLI patients has improved over the past decade, possibly due to more revascularizations, particularly distal ones, and increased statin use.

Objective: Individual studies of peripheral artery disease (PAD) have indicated that gender discrepancies exist in the symptoms, functional status, and treatment usage. It remains uncertain whether these discrepancies result in different long-term outcomes. We examined the potential gender differences in mortality and major adverse cardiovascular events (MACE) in patients with symptomatic PAD., Methods: The PubMed and Embase databases were searched for studies from 2000 to January 2019. After a review of 13,582 citations, 14 articles were analyzed. The reported age-adjusted hazard ratios (HRs) for gender differences in mortality and MACE were included in the meta-analysis. The mortality outcomes were stratified according to the clinical presentation and study context., Results: Male gender was associated with a greater risk of all-cause mortality (HR, 1.13; 95% confidence interval [CI], 1.10-1.16; P < .001) and MACE (HR, 1.10; 95% CI, 1.06-1.14; P < .001). In a stratified analysis, male gender was associated with a higher mortality risk for patients presenting with either critical limb ischemia (HR, 1.08; 95% CI, 1.05-1.10; P < .001) or mixed clinical presentations (HR, 1.16; 95% CI, 1.11-1.21; P < .001) but not for those with intermittent claudication (HR, 1.13; 95% CI, 0.98-1.30; P = .09). Elevated mortality risk was evident after revascularization (HR, 1.11; 95% CI, 1.04-1.19; P = .003), hospitalization (HR, 1.15; 95% CI, 1.08-1.22; P < .001), and amputation (HR, 1.09; 95% CI, 1.08-1.10; P < .001), although not in outpatient clinics (HR, 1.13; 95% CI, 0.97-1.32; P = .13), in men compared with women., Conclusions: Greater mortality and MACE rates in men with PAD occurred despite other accepted gender disparities. The mechanisms underlying these gender differences in the outcomes for PAD patients require further investigation., (Copyright © 2020 Society for Vascular Surgery. All rights reserved.)

Background: Sarcopenia is a factor of poor prognosis for patients with critical limb threatening ischemia (CLTI), but its diagnosis requires imaging measurements and is time consuming. We investigated whether preoperative platelet-to-lymphocyte ratio (PLR) could be an easy and rapid marker of sarcopenia., Methods: Patients treated for CLTI between January 2019 and July 2019 were included in this single-center retrospective study. Sarcopenia was defined by a psoas muscle index (PMI) <5.5 cm 2 /m 2 in men, and <4.0 cm 2 /m 2 in women. PLR was calculated for all patients based on their systematic preoperative blood analysis. The diagnostic power of PLR was analyzed through a receiver operating characteristic (ROC) curve. Early outcomes of sarcopenic patients in terms of 30-day mortality and 30-day morbidity were retrieved., Results: Sixty-four patients were included in the study: 48 nonsarcopenic patients (mean PMI 7.34 cm 2 /m 2 ; interquartile range [IQR] 6.58-8.01) and 16 sarcopenic patients (mean PMI 4.30 cm 2 /m 2 ; IQR 3.45-5.17). No difference was found between both groups regarding patient demographics, clinical characteristics, cardiovascular risk factors, comorbidities, or revascularization modalities. PLR was significantly higher in the sarcopenic group (mean 332.1; IQR 158.2-320.7) compared with the nonsarcopenic group (mean 204.6; IQR 133.8-265.6) (P = 0.02). A PLR value ≥292.5 was shown to be a diagnostic marker for sarcopenia based on the ROC curve (sensitivity 31.3%, specificity 91.7%). Thirty-day mortality was 12.5% in the sarcopenic group and 2.1% in the nonsarcopenic group (P = 0.15); 30-day morbidity was 56.3% in the sarcopenic group and 10.4% in the nonsarcopenic group (P < 0.001)., Conclusions: PLR might help identifying a subgroup of CTLI patients associated with poor prognosis but does not seem appropriate to be used as a marker of sarcopenia given its low sensitivity., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Peripheral arterial disease (PAD) is associated with reduced lower limb blood flow and tissue perfusion. The consequent reduction in vessel wall shear stress as well as ischemia-reperfusion injury has also been associated with systemic endothelial dysfunction and inflammation. We aimed to explore the impact of lower limb revascularization on (1) lower limb blood flow, (2) tissue perfusion, and (3) systemic endothelial function. We performed a systematic literature search using the MEDLINE, Embase, and Web of Science databases. Eligible studies measured changes in lower limb blood flow, perfusion, or systemic endothelial function following revascularization for the treatment of symptomatic PAD. We found 19 eligible studies, which were limited by considerable heterogeneity. Current evidence suggests that revascularization has a positive effect on flow, perfusion, and systemic endothelial dysfunction. Any changes may take a number of weeks to become apparent. There is a need for well-designed studies to explore the association between flow, perfusion, and endothelial dysfunction.

Purpose: To evaluate the feasibility of a new optical device that measures peripheral blood flow as a diagnostic and monitoring tool for patients with peripheral artery disease (PAD)., Materials and Methods: In this prospective study, 167 limbs of 90 patients (mean age, 76 y; 53% men) with suspected PAD were evaluated with the FlowMet device, which uses a new type of dynamic light-scattering technology to assess blood flow in real time. Measurements of magnitude and phasicity of blood flow were combined into a single-value flow-waveform score and compared vs ankle-brachial index (ABI), toe-brachial index (TBI), and clinical presentation of patients per Rutherford category (RC). Receiver operating characteristic curves were constructed to predict RC. Area under the curve (AUC), sensitivity, and specificity were compared among flow-waveform score, ABI, and TBI., Results: Qualitatively, the FlowMet waveforms were analogous to Doppler velocity measurements, and degradation of waveform phasicity and amplitude were observed with increasing PAD severity. Quantitatively, the flow, waveform, and composite flow-waveform scores decreased significantly with decreasing TBI. In predicting RC ≥ 4, the flow-waveform score (AUC = 0.83) showed a linear decrease with worsening patient symptoms and power comparable to that of TBI (AUC = 0.82) and better than that of ABI (AUC = 0.71). Optimal sensitivity and specificity pairs were found to be 56%/83%, 72%/81%, and 89%/74% for ABI, TBI, and flow-waveform score, respectively., Conclusions: The technology tested in this pilot study showed a high predictive value for diagnosis of critical limb ischemia. The device showed promise as a diagnostic tool capable of providing clinical feedback in real time., (Copyright © 2020 SIR. Published by Elsevier Inc. All rights reserved.)