Recent advances and controversial issues in the optimal management of asymptomatic carotid stenosis.

OBJECTIVE: The optimal management of patients with asymptomatic carotid stenosis (AsxCS) is enduringly controversial. We updated our 2021 Expert Review and Position Statement, focusing on recent advances in the diagnosis and management of patients with AsxCS. METHODS: A systematic review of the literature was performed up to August 1, 2023, using PubMed/PubMed Central, EMBASE and Scopus. The following keywords were used in various combinations: "asymptomatic carotid stenosis," "carotid endarterectomy" (CEA), "carotid artery stenting" (CAS), and "transcarotid artery revascularization" (TCAR). Areas covered included (i) improvements in best medical treatment (BMT) for patients with AsxCS and declining stroke risk, (ii) technological advances in surgical/endovascular skills/techniques and outcomes, (iii) risk factors, clinical/imaging characteristics and risk prediction models for the identification of high-risk AsxCS patient subgroups, and (iv) the association between cognitive dysfunction and AsxCS. RESULTS: BMT is essential for all patients with AsxCS, regardless of whether they will eventually be offered CEA, CAS, or TCAR. Specific patient subgroups at high risk for stroke despite BMT should be considered for a carotid revascularization procedure. These patients include those with severe (≥80%) AsxCS, transcranial Doppler-detected microemboli, plaque echolucency on Duplex ultrasound examination, silent infarcts on brain computed tomography or magnetic resonance angiography scans, decreased cerebrovascular reserve, increased size of juxtaluminal hypoechoic area, AsxCS progression, carotid plaque ulceration, and intraplaque hemorrhage. Treatment of patients with AsxCS should be individualized, taking into consideration individual patient preferences and needs, clinical and imaging characteristics, and cultural, ethnic, and social factors. Solid evidence supporting or refuting an association between AsxCS and cognitive dysfunction is lacking. CONCLUSIONS: The optimal management of patients with AsxCS should include BMT for all individuals and a prophylactic carotid revascularization procedure (CEA, CAS, or TCAR) for some asymptomatic patient subgroups, additionally taking into consideration individual patient needs and preference, clinical and imaging characteristics, social and cultural factors, and the available stroke risk prediction models. Future studies should investigate the association between AsxCS with cognitive function and the role of carotid revascularization procedures in the progression or reversal of cognitive dysfunction.

An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Inflammation Is a Histological Characteristic of Skeletal Muscle in Chronic Limb Threatening Ischemia.

BACKGROUND: The loss of skeletal muscle is a prognostic factor in several diseases including in patients with chronic limb threatening ischemia (CLTI). Patients with CLTI also have a lower skeletal mass and area when compared to those with claudication. However, there are no currently available data regarding the histological characteristics of core muscles in patients with CLTI. This study aims to determine the differences in core skeletal muscles between patients with claudication and those with CLTI. The second aim is to evaluate the differences in myokines, which are molecules secreted by skeletal muscle, between patients with claudication and those with CLTI. METHODS: An observational, prospective study was conducted from January 2018 to July 2022 involving consecutive patients with peripheral arterial disease (PAD). The clinical characteristics were registered. In PAD patients with surgical indication for common femoral artery approach, samples of sartorius skeletal muscle (and not from the limb muscles directly involved in the ischemic process) were collected. The samples were submitted to histological characterization on hematoxylin-eosin and to immunohistochemical analysis to detect CD45+ leukocytes and CD163+ macrophages. The extent of the inflammatory cells (leukocytes and macrophages) was semiquantitatively assessed using a 0-to-4 grade scale as follows: absent (0†), mild (†), moderate (††), severe (†††), and very severe (††††). Serum levels of myokines: irisin, myostatin, IL-8, and lL-6 were determined with multiplex bead-based immunoassay. RESULTS: 119 patients (mean age: 67.58 ± 9.60 years old, 79.80% males) 64 with claudication and 54 with CLTI were enrolled in the study. No differences were registered between patients with claudication and those with CLTI on age, gender, cardiovascular risk factors, and medication, except on smoking habits. There was a significantly higher prevalence of smokers and a higher smoking load in the claudication group. Samples of sartorius skeletal muscle from 40 patients (14 with claudication and 26 with CLTI) were submitted to histological analysis. No differences were found in skeletal muscle fibers preservation, trauma, or hemorrhage (on hematoxylin-eosin staining). However, in the immunohistochemistry study, we found more inflammatory cells CD45+ leukocytes in patients with CLTI when compared to those with claudication [CD45+ ≥ moderate (††): claudication (n = 14): 4; 28.57%; CLTI (n = 25): 16; 64.00%; P = 0.034]. Patients with CLTI also had higher tissue levels of CD163+ macrophages, but this difference was not significant [CD163+ ≥ moderate (††): claudication (n = 13): 7; 53.85%; CLTI (n = 27): 21; 77.78%; P = 0.122]. The serum levels of the myokines, irisin, and myostatin were below the lower limit of detection, in the majority of patients, so no valid results were obtained. However, patients with CLTI had a higher serum level of Interleukin (IL)-6 and IL-8. CONCLUSIONS: CLTI patients exhibit increased quantities of leukocytes in their sartorius muscle, as well as elevated serum levels of myokines IL-8 and IL-6. Inflamed skeletal muscle can contribute to the loss of muscle mass and account for the lower density of skeletal muscle observed in CLTI. Additionally, inflamed skeletal muscle may contribute to the development of systemic inflammation through the secretion of pro-inflammatory cytokines into the systemic circulation. Halting the inflammatory process could eventually improve the prognosis of CLTI patients.

Higher Levels of Cytokines in Patients with Chronic Limb-Threatening Ischemia.

BACKGROUND: Inflammation is a key element in the initiation and progression of peripheral arterial disease (PAD). Understanding the impact of inflammatory molecules, as cytokines in PAD could help us to improve the prognosis of these patients. The main goal of this study was to compare the serum level of cytokines between patients with claudication to those with chronic limb-threatening ischemia (CLTI). The second objective was to evaluate the relationship between the levels of cytokines and death or amputation rate. METHODS: An observational, single-center, and prospective study was conducted from January 2018 to July 2022. The study was approved by the ethical commission of the Local Hospital (75/2017). Patients with PAD, suggested by the clinical history and objective examination and confirmed with ankle-brachial index, attending vascular surgery consultations of the first author were included. The following exclusion criteria were applied: i) bedridden individuals or subjects who refused to participate in the protocol; ii) diseases responsible for body composition changes or proinflammatory state; iii) recent diet change, iv) active malignancy, v) autoimmune disease, vi) active infection, vii) chronic renal failure (glomerular filtration rate <30 mL/min/1.73 m2), or viii) heart failure in the past 3 months. This cohort was observed at admission, 3, 6, and 12 months. A panel of 27 cytokines was determined with ELISA, at baseline. RESULTS: We included 119 subjects (mean age: 67.58 ± 9.60 years old; 79.80% males), 65 patients with claudication and 54 with CLTI. From the 27 cytokines analyzed, patients with CLTI, when compared to those with claudication, had a higher serum level of 11 cytokines: IL1ra, IL-6, IL-8, IL12 p70, G-CSF, IP-10, MCP-1, MIP-1α, PDGF-ß, RANTES, and TNF-α. From the group of patients with CLTI those who underwent a major amputation had a higher serum level of FGF-basic [median = 49.04; interquartile range = 37.03-52.49; versus median = 33.04; interquartile range = 28.60-38.98; P = 0.001]. CONCLUSIONS: Patients with CLTI have higher serum level of inflammatory cytokines, which may have role in the prognosis of these patients.

A Delphi Consensus Study on Undergoing Carotid Endarterectomy: Patient Reported Outcome Measures.

OBJECTIVE: Currently, evidence is lacking for disease specific patient reported outcome measures (PROMs) for use in atherosclerotic carotid artery stenosis (either symptomatic or asymptomatic) submitted to carotid endarterectomy (CEA). This study aimed to obtain expert consensus on the most important items to include in a PROM designed to capture the impact of atherosclerotic carotid artery stenosis and its treatment on health related quality of life. METHODS: A three round modified Delphi consensus study was performed. A mixed expert Delphi panel of doctors (international panel of dedicated vascular surgeons and neurologists) and patients (either symptomatic or asymptomatic patients meeting criteria for carotid artery revascularisation) was implemented. The aim was to obtain pre-defined consensus on items in four pre-defined domains: generic, quality of life, symptom related, and treatment related. Consensus was reached in rounds two and three with > 70% overall expert agreement. RESULTS: The experts agreed on 23 items (out of 49) which were distributed as follows: five in the generic, six in the quality of life, six in the symptom, and six in the treatment related domain. Interestingly, comparing the items that reached consensus in this study, with the generic and disease specific PROMs previously used in carotid artery disease investigation, the only constant items were "difficulty with walking" and "ability to perform daily activities" included in the symptom domain. Considering the items that reached expert consensus in the additional domains, emphasis was given to the impact of the diagnosis, treatment and follow up, and to fear or concern "about the future" and "about severe stroke". In the treatment domain emphasis was also attained on the side effects, long term patient satisfaction, and on the information provided regarding treatment options. DISCUSSION: As hard clinical outcomes become increasingly rare, assessment of the impact of CEA becomes increasingly difficult. The consensus reached provides a newly defined disease specific PROM that warrants independent validation in specific populations in the future.

Inflammation and Loss of Skeletal Muscle Mass in Chronic Limb Threatening Ischemia.

BACKGROUND: Lower extremity peripheral arterial disease (PAD) is an atherosclerotic disease of the lower extremities. Atherosclerosis, inflammation, and sarcopenia are independently associated and potentiate each other. Inflammation is deeply involved in the formation and progression of atherosclerosis and is also involved in the pathophysiology of sarcopenia. Sarcopenia is defined as low muscle mass, with low muscle strength. This study aims to determine the differences in skeletal muscle characteristics and in inflammatory parameters between patients with claudication and with chronic limb threatening ischemia (CLTI). METHODS: An observational, prospective study in patients with PAD was conducted from January 2018 to December 2020. The clinical characteristics and the cardiovascular risk factors were prospectively registered. The inflammatory parameters determined were: positive acute phase proteins (C-reactive Protein- CRP- and fibrinogen) and negative acute phase proteins albumin, total cholesterol and high-density lipoprotein (HDL). The skeletal muscle area and density were quantified with a computed topography (CT) scan. The strength was determined with a Jamar® hydraulic hand dynamometer. RESULTS: A total of 116 patients (mean age: 67.65 ± 9.53 years-old) 64% with claudication and 46% with CLTI were enrolled in the study. No differences were registered between patients with claudication and CLTI on age, cardiovascular risk factors (hypertension, dyslipidemia, diabetes mellitus, and smoking habits) and medication. There was a higher prevalence of men in the claudication group (88.89% vs. 71.70%, P = 0.019). Analyzing the inflammatory parameters, we noted that patients with CLTI had increased serum levels of positive acute phase proteins: CRP (37.53 ± 46.61 mg/L vs. 9.18 ± 26.12 mg/L, P = 0.000), and fibrinogen (466.18 ± 208.07 mg/dL vs. 317.37 ± 79.42 mg/dL, P = 0.000). CLTI patients had decreased negative acute phase proteins: albumin (3.53 ± 0.85 g/dL vs. 3.91 ± 0.72 g/dL, P = 0.001), total cholesterol (145.41 ± 38.59 mg/dL vs. 161.84 ± 34.94 mg/dL, P = 0.013) and HDL (38.70 ± 12.19 mg/dL vs. 51.31 ± 15.85 mg/dL, P = 0.000). We noted that patients with CLTI had lower skeletal muscle area and mass (14,349.77 ± 3,036.60 mm2 vs. 15,690.56 ± 3,183.97 mm2P = 0.013; 10.11 ± 17.03HU vs. 18.02 ± 13.63HU P = 0.013). After adjusting for the variable sex, the association between skeletal muscle density and CLTI persisted (r (97) = -0.232, P = 0.021). The groups did not differ in strength (patients with claudication: 25.39 ± 8.23 Kgf vs. CLTI: 25.17 ± 11.95 Kgf P = 0.910). CONCLUSIONS: CLTI patients have decreased skeletal muscle mass and a systemic inflammation status. Recognizing the deleterious triad of atherosclerosis, inflammation and loss of skeletal mass patients with CLTI is an opportunity to improve medical therapy and to perform a timely intervention to stop this vicious cycle.

Critical analysis of the literature and standards of reporting on stroke after carotid revascularization.

OBJECTIVE: Mechanisms of procedural stroke after carotid endarterectomy (CEA) or carotid artery stenting are surprisingly underresearched. However, understanding the underlying mechanism could (1) assist in balancing the choice for revascularization vs conservative therapy, (2) assist in choosing either open or endovascular techniques, and (3) assist in taking appropriate periprocedural measures to further decrease procedural stroke rate. The purpose of this study was to overview mechanisms of procedural stroke after carotid revascularization and establish reporting standards to facilitate more granular investigation and individual patient data meta-analysis in the future. METHODS: A systematic review was conducted according to the PRISMA statement. RESULTS: The limited evidence in the literature was heterogeneous and of low quality. Thus, no formal data meta-analysis could be performed. Procedural stroke was classified as hemorrhagic or ischemic; the latter was subclassified as hemodynamic, embolic (carotid embolic or cardioembolic) or carotid occlusion derived, using a combination of clinical inference and imaging data. Most events occurred in the first 24 hours after the procedure and were related to hypoperfusion (pooled incidence 10.2% [95% confidence interval (CI), 3.0-17.5] vs 13.9% [95% CI, 0.0-60.9] after CEA vs carotid artery stenting events, respectively) or atheroembolism (28.9% [95% CI, 10.9-47.0]) vs 34.3 [95% CI, 0.0-91.5]). After the first 24 hours, hemorrhagic stroke (11.6 [95% CI, 5.7-17.4] vs 9.0 [95% CI, 1.3-16.7]) or thrombotic occlusion (18.4 [95% CI, 0.9-35.8] vs 14.8 [95% CI, 0.0-30.5]) became more likely. CONCLUSIONS: Although procedural stroke incidence and etiology may have changed over the last decades owing to technical improvements and improvements in perioperative monitoring and quality control, the lack of literature data limits further statements. To simplify and enhance future reporting, procedural stroke analysis and classification should be documented preemptively in research settings. We propose a standardized form enclosing reporting standards for procedural stroke with a systematic approach to inference of the most likely etiology, for prospective use in registries and randomized controlled trials on carotid revascularization.

Editor's Choice - Timing of Carotid Intervention in Symptomatic Carotid Artery Stenosis: A Systematic Review and Meta-Analysis.

OBJECTIVE: This review aimed to analyse the timing of carotid endarterectomy (CEA) and carotid artery stenting (CAS) after the index event as well as 30 day outcomes at varying time periods within 14 days of symptom onset. METHODS: A systematic review was performed according to the Preferred Reporting Items for Systematic reviews and Meta-analysis statement, comprising an online search of the Medline and Cochrane databases. Methodical quality assessment of the included studies was performed. Endpoints included procedural stroke and/or death stratified by delay from the index event and surgical technique (CEA/CAS). RESULTS: Seventy-one studies with 232 952 symptomatic patients were included. Overall, 34 retrospective analyses of prospective databases, nine prospective, three RCT, three case control, and 22 retrospective studies were included. Compared with CEA, CAS was associated with higher 30 day stroke (OR 0.70; 95% CI 0.58 - 0.85) and mortality rates (OR 0.41; 95% CI 0.31 - 0.53) when performed ≤ 2 days of symptom onset. Patients undergoing CEA/CAS were analysed in different time frames (≤ 2 vs. 3 - 14 and ≤ 7 vs. 8 - 14 days). Expedited CEA (vs. 3 - 14 days) presented a sampled 30 day stroke rate of 1.4%; 95% CI 0.9 - 1.8 vs. 1.8%; 95% CI 1.8 - 2.0, with no statistically significant difference. Expedited CAS (vs. 3 - 14 days) was associated with no difference in stroke rate but statistically significantly higher mortality rate (OR 2.76; 95% CI 1.39 - 5.50). CONCLUSION: At present, CEA is safer than transfemoral CAS within 2/7 days of symptom onset. Also, considering absolute rates, expedited CEA complies with the accepted thresholds in international guidelines. The ideal timing for performing CAS (when indicated against CEA) is not yet defined. Additional granular data and standard reporting of timing of intervention will facilitate future monitoring.

Association of Skeletal Muscle and Cardiovascular Risk Factors in Patients with Lower Extremity Arterial Disease.

BACKGROUND: Sarcopenia is defined as low muscle mass, with low muscle strength or low physical performance. The skeletal muscle mass (or density) and strength are inversely associated with cardiovascular risk factors. We aim to determine the relationship between skeletal muscle characteristics (strength, mass, area), and cardiovascular risk factors in a population with lower extremity artery disease (LEAD). METHODS: An observational, prospective study including patients with LEAD was conducted from January 2018 to December 2020. The cardiovascular risk factors and anthropometric measurements were prospectively registered. The skeletal muscle characteristics (area, density/mass and strength) were analysed. The skeletal muscle area and density were quantified with a CT scan. The strength was determined with a Jamar® hydraulic hand dynamometer. RESULTS: A total of 96 patients with LEAD with 67.70 ± 10.11 years-old were enrolled in the study. The most prevalent cardiovascular risk factor was hypertension, followed by dyslipidemia and diabetes. Patients with diabetes had a lower handgrip strength and skeletal muscle density, when compared with patients without diabetes (strength: 19.67 ± 9.98 kgf vs. 26.79 ± 11.80 kgf, P = 0.002 and skeletal muscle density: 10.58 ± 17.61 HU vs. 18.17 ± 15.33 HU, P = 0.032). There was a trend for the association between the presence of cardiovascular risk factors (hypertension and dyslipidemia) and a decrease in skeletal muscle density and strength (density: hypertension: 13.46 ± 16.74 HU vs. 20.38 ± 11.63 HU P=0.055; dyslipidemia: 13.57 ± 17.16 HU vs. 17.74 ± 13.00 HU P= 0.315; strength- hypertension: 22.55 ± 10.08 kgf vs. 27.58 ± 15.11 P= 0.073; dyslipidemia: 22.80 ± 10.52 kgf vs. 25.28 ± 13.14 kgf P= 0.315). Interestingly, we found that smokers had a favorable skeletal muscle characteristic, which could be explained by the higher prevalence of diabetes in nonsmokers. CONCLUSIONS: The indicators of skeletal muscle dysfunction (strength and density) are associated to the presence of diabetes in patients with LEAD. Therapeutic strategies to improve the skeletal muscle characteristics could have a role in improving LEAD risk factors, particularly diabetes.

Optimal Management of Asymptomatic Carotid Stenosis in 2021: The Jury is Still Out. An International, Multispecialty, Expert Review and Position Statement.

OBJECTIVES: The recommendations of international guidelines for the management of asymptomatic carotid stenosis (ACS) often vary considerably and extend from a conservative approach with risk factor modification and best medical treatment (BMT) alone, to a more aggressive approach with a carotid intervention plus BMT. The aim of the current multispecialty position statement is to reconcile the conflicting views on the topic. MATERIALS AND METHODS: A literature review was performed with a focus on data from recent studies. RESULTS: Several clinical and imaging high-risk features have been identified that are associated with an increased long-term ipsilateral ischemic stroke risk in patients with ACS. Such high-risk clinical/imaging features include intraplaque hemorrhage, impaired cerebrovascular reserve, carotid plaque echolucency/ulceration/ neovascularization, a lipid-rich necrotic core, a thin or ruptured fibrous cap, silent brain infarction, a contralateral transient ischemic attack/stroke episode, male patients < 75 years and microembolic signals on transcranial Doppler. There is growing evidence that 80-99% ACS indicate a higher stroke risk than 50-79% stenoses. CONCLUSIONS: Although aggressive risk factor control and BMT should be implemented in all ACS patients, several high-risk features that may increase the risk of a future cerebrovascular event are now documented. Consequently, some guidelines recommend a prophylactic carotid intervention in high-risk patients to prevent future cerebrovascular events. Until the results of the much-anticipated randomized controlled trials emerge, the jury is still out regarding the optimal management of ACS patients.

Aneurysm Volumes After Endovascular Repair of Ruptured vs Intact Aortic Aneurysms: A Retrospective Observational Study.

PURPOSE: To compare changes in abdominal aortic aneurysm (AAA) sac volume between endovascular aneurysm repairs (EVAR) performed for ruptured (rEVAR) vs intact (iEVAR) AAAs and to determine the impact of early volume shrinkage on future complications. MATERIALS AND METHODS: A retrospective analysis was performed of all patients undergoing standard infrarenal EVAR from 2002 to 2016 at a tertiary referral institution. Only patients with degenerative AAAs and with 30-day and 1-year computed tomography angiography (CTA) imaging were included. Early sac shrinkage was defined as a volume sac reduction >10% between the first (<30-day) and the 1-year CTA. The primary endpoint was to compare AAA sac volume changes between patients undergoing rEVAR (n=51; mean age 71.0±8.5 years; 46 men) vs iEVAR (n=393; mean age 72.3±7.5 years; 350 men). Results are reported as the mean difference with the interquartile range (IQR Q1, Q3). The secondary endpoint was freedom from aneurysm-related complications after 1 year as determined by regression analysis; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: At baseline, the rEVAR group had larger aneurysms (p<0.001) and shorter (p<0.001) and more angulated (p=0.028) necks. Aneurysm sac volume decreased more in the rEVAR group during the first year [-26.3% (IQR -38.8%, -12.5%)] vs the iEVAR group [-11.9% (IQR -27.5%, 0); p<0.001]. However, after the first year, the change in sac volume was similar between the groups [-3.8% (IQR -32.9%, 31.9%) for rEVAR and -1.5% (IQR -20.9%, 13.6%) for iEVAR, p=0.74]. Endoleak occurrence during follow-up was similar between the groups. In the overall population, patients with early sac shrinkage had a lower incidence of complications after the 1-year examination (adjusted HR 0.59, 95% CI 0.39 to 0.89, p=0.01). CONCLUSION: EVAR patients treated for rupture have more pronounced aneurysm sac shrinkage compared with iEVAR patients during the first year after EVAR. Patients presenting with early shrinkage are less likely to encounter late complications. These parameters may be considered when tailoring surveillance protocols.

Impact of intraoperative neurologic deficits in carotid endarterectomy under regional anesthesia.

OBJECTIVE: Patients undergoing carotid endarterectomy (CEA) may experiment neurologic deficits during the carotid cross-clamping due to secondary cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established. This work aimed to assess the postoperative adverse events related to neurologic deficits in the awake test after clamping and to determine its predictive factors. Methods. From January 2012 to January 2018, 79 patients from a referral hospital that underwent CEA with regional anesthesia for carotid stenosis and manifested neurologic deficits were gathered. Consecutively selected controls (n = 85) were submitted to the same procedure without developing neurological changes. Postoperative complications such as stroke, myocardial infarction, all-cause death, and Clavien-Dindo classification were assessed 30 days after the procedure. Univariate and binary logistic regressions were performed for data assessment. Results. Patients with clamping associated neurologic deficits were significantly more obese than the control group (aOR = 9.30; 95% CI: 2.57-33.69; p = .01). Lower degree of ipsilateral stenosis and higher degree of contralateral stenosis were independently related to clamping intolerance (aOR = 0.70; 95% CI: 0.49-0.99; p = .047 and aOR = 1.30; 95% CI: 1.06-1.50; p = .009, respectively). Neurologic deficits were a main 30-day stroke predictor (aOR = 4.30; 95% CI: 1.10-16.71; p = .035). Conclusions. Neurologic deficits during carotid clamping are a predictor of perioperative stroke. Body mass index > 30 kg/m2, a lower degree of ipsilateral stenosis, and a higher degree of contralateral stenosis are independent predictors of neurologic deficits and, therefore, might play a role in the prevention of procedure-related stroke.

Sarcopenia as a Prognostic Factor in Peripheral Arterial Disease: Descriptive Review.

BACKGROUND: Determine the influence of sarcopenia on the prognosis of peripheral arterial disease (PAD). METHODS: A systematic search of the PubMed and Cochrane Library databases was performed with the keywords and medical subject heading (MesH): "muscle, skeletal", "sarcopenia", "prognosis", "duration of stay", "death", "mortality", "patient readmission", "length of stay", "peripheral arterial disease", "intermittent claudication" and "critical limb ischemia". Papers published from January 2010 to October 2020 in English, French, Spanish and Portuguese were eligible for inclusion. The primary outcome was overall survival. Secondary outcomes included post-operative complications, amputation, length of hospital stay and hospital readmission. RESULTS: Of 1071 papers, 8 articles and 1511 patients were included (68.96% male, mean age 71.83 years). Five papers found an inverse relationship between SM area and mortality. Matsubara (2015) found that the 5-year overall survival rates were lower for patients with sarcopenia (23.5% ± 0.18% vs 77.5% ± 0.09% P = 0.001). Matsubara (2016) registered 3-year cardiovascular event-free survival rates of 43.1% and 91.2% for patients with and without sarcopenia (P < 0.01). Juszczak (2018) found that survival was lower in patients with reduced total psoas area. Taniguchi (2019) found that 3-year overall survival rate was 60% for patients with sarcopenia and 87% for patients without sarcopenia (P < 0.05). Shimazoe (2019) concluded sarcopenia was a significant predictor of overall survival. Distinctly, Nyers (2017) concluded that higher ratio bilateral psoas area to L4 vertebral body was associated with an increased risk of death. Two other studies analyzed other characteristics of the SM (density and strength). McDermott (2012) and found that lower calf muscle density and strength were associated with an increase in mortality. Sugai (2019) concluded that patients with major cardiovascular and limb events had a lower SM density. CONCLUSIONS: Lower SM area and mass seem to be associated with a higher mortality in PAD patients.

Critical Appraisal on the Quality of Reporting on Safety and Efficacy of Transcarotid Artery Stenting With Flow Reversal.

Transcarotid revascularization is an alternative to transfemoral carotid artery stenting, designed to avoid aortic arch manipulation and concomitant periprocedural stroke. This article aims to perform a detailed analysis on the quality of the currently available evidence on safety and efficacy of transcarotid artery revascularization. Although current evidence is promising, independent randomized controlled studies comparing transcarotid artery revascularization with carotid endarterectomy in recently symptomatic patients are lacking and will be necessary to establish the true value of transcarotid artery revascularization in carotid artery revascularization.

Long-term results after standard endovascular aneurysm repair with the Endurant and Excluder stent grafts.

OBJECTIVE: Many endografts are currently available for standard endovascular repair of infrarenal abdominal aortic aneurysms. Comparison of long-term outcomes between devices might aid in this decision process, but comparative data are scarce. The purpose of this study was to report long-term clinical outcomes of two commercially available endoprosthesis, the Endurant (Medtronic Vascular, Inc, Minneapolis, Minn) and the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) stent grafts. METHODS: Patients undergoing standard endovascular repair from July 2004 to December 2011 in a single institution with the Endurant or the Low-Porosity Excluder endografts were eligible. Only patients treated for intact degenerative abdominal infrarenal aneurysms were included. All measurements were performed on center-lumen line reconstructions obtained on dedicated software. The primary end point was primary clinical success, defined as clinical success without the need for an additional or secondary surgical or endovascular procedure. Neck-related events (a composite of type IA endoleak, neck-related secondary intervention, or migration of >5 mm), neck morphology changes, renal function, and overall survival were secondary end points. RESULTS: The study included 277 patients (156 Endurants; 121 Excluders). The median follow-up was 5.8 years (range, 0.1-12.4 years) and did not differ between groups (P = .18). Patients treated with the Endurant stent graft had wider (neck diameter of >28 mm, 27.3% vs 1.7% [P < .001]; neck diameter of 27 mm, [interquartile range (IQR), 24-29 mm] for Endurant and 24 mm [IQR, 22-25 mm] for Excluder; P < .001) and more angulated necks (ß-angle of >60°, 26.7% vs 12.5%; P = .004). Oversizing was greater in the Endurant group (16% [IQR, 12%-22%] vs 13% [IQR, 8%-17%], respectively; P < .001). Patients were treated outside device instructions for use regarding proximal neck: 16.7% in the Endurant and 17.3% in the Excluder group (P = .720). The 7-year primary clinical success was 54.7% for the Endurant and 58.1% for the Excluder groups (P = .53). Freedom from neck-related events at 7 years was 76.7% for the Endurant and 78.8% for Excluder group (P = .94). The Endurant stent graft (hazard ratio [HR], 2.7; 95% confidence interval [CI], 1.3-5.8; P = .009) was an independent predictor of significant renal function decline. Neck dilatation was greater in Endurant-implanted patients (13% [95% CI, 2%-22%] vs 4% [95% CI, 0%-10%]; P < .001). Overall survival at 7 years was 61.4% in the Endurant and 50.3% (n = 50; standard error, 0.047) in the Excluder group (P = .39). CONCLUSIONS: This study reveals that durable and sustainable results can be obtained with either of these late generation devices. This finding suggests that careful planning and a tailored device selection taking into account the patient's anatomy are more relevant determinants than the graft model itself to obtain clinical success. The Endurant endoprosthesis seems to be associated with a higher rate of neck dilatation and faster decrease in the estimated glomerular filtration rate, but further studies with longer follow-up are necessary to determine the clinical relevance of these findings.

Comparison of midterm results of endovascular aneurysm repair for ruptured and elective abdominal aortic aneurysms.

OBJECTIVE: Endovascular aneurysm repair (EVAR) became an increasingly preferred modality for abdominal aortic aneurysm (AAA) repair both in elective AAA repair (el-EVAR) and EVAR of a ruptured AAA (r-EVAR) setting. Ruptured AAAs usually have more hostile anatomies and less time for planning. Consequently, more complications may arise after r-EVAR. The purpose of this study was to compare mi-term outcomes between r-EVAR and el-EVAR. METHODS: A retrospective cohort analysis of patients undergoing EVAR from 2000 to 2015 at a tertiary institution was performed. Patients with previous aortic surgery, nonatherosclerotic AAA and isolated iliac aneurysms were excluded. In-hospital casualties or patients who were intraoperatively converted to open repair were also excluded. For the midterm outcome analysis, only patients with at least two postoperative examinations (a 30-day computed tomography scan and a second postoperative examination performed 6 months or later) were considered. The primary end point was freedom from aneurysm-related complications (a composite of type I or III endoleak, aneurysm sac growth, migration of more than 5 mm, device integrity failure, AAA-related death, late postimplant rupture, or AAA-related secondary intervention). Freedom from secondary interventions, neck-related events (defined as a composite of type IA endoleak, migration of more than 5 mm, or preemptive neck-related secondary intervention) and late survival were secondary end points. The impact of device instructions for use (IFU) compliance on neck events was also assessed. RESULTS: The study included 565 patients (65 r-EVAR and 500 el-EVAR). Eighty-two patients were treated outside proximal neck IFU, 13 in the r-EVAR group (21.3%) and 69 (14.5%) in the el-EVAR (P = .16). During the index hospitalization, there were more complications (12.3% vs 3.2%; P = .001) and reinterventions (12.3% vs 2.8%; P < .001) in the r-EVAR group. After discharge, median clinical follow-up time was 4.3 years (interquartile range, 2.1-7.0 years) without differences between both groups. Five-year freedom from AAA-related complications was 53.9% in the r-EVAR group and 65.4% in the el-EVAR (P = .21). In multivariable analysis the r-EVAR group was not at increased risk for late complications (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.54-1.61; P = .81). Five-year freedom from neck-related events was 74% in r-EVAR and 82% in the el-EVAR group (P = .345). Patients treated outside neck IFU were at greater risk for neck-related events both in r-EVAR (HR, 6.5; 95% CI, 1.8-22.9; P = .004) and el-EVAR group (HR, 2.6; 95% CI, 1.5-4.5; P < .001). Freedom from secondary interventions at 5 years was 63.0% for r-EVAR and 76.9% for el-EVAR (P = .16). Survival at 5 years was 68.8% in the r-EVAR group and 73.3% in the el-EVAR group (P = .30). CONCLUSIONS: Durable and sustainable midterm outcomes were found for both r-EVAR and el-EVAR patients who survived the postoperative period. Patients treated outside the IFU are at greater risk for late complications. Surveillance protocols may be tailored according to individual anatomy and IFU compliance rather than timing of repair.

Total Luminal Volume Predicts Risk after Endovascular Aneurysm Repair.

OBJECTIVE: Large aneurysm diameter represents a well known predictor of late complications after endovascular aneurysm repair (EVAR). However, the role of the thrombus free lumen inside the abdominal aortic aneurysm (AAA) sac is not clear. It was hypothesised that greater luminal volume represents a relevant risk factor for late complications after EVAR. METHODS: A retrospective cohort analysis was performed including all patients undergoing EVAR from 2005 to 2016 at a tertiary referral institution. Pre-operative AAA lumen volume was measured in centre lumen line reconstructions and patients were stratified into quartiles according to luminal volume. The primary endpoint was freedom from AAA related complications. Secondary endpoints were freedom from neck events (type 1A endoleak, migration >5 mm or any pre-emptive neck related intervention), iliac related events (type 1B endoleak or pre-emptive iliac related intervention), and overall survival. RESULTS: Four hundred and four patients were included: 101 in the first quartile (Q1; <61 cm3). Patients with higher luminal volumes had wider, shorter, and more angulated proximal necks. There were more ruptured AAAs, more aorto-uni-iliac implanted devices and patients outside neck instructions for use in the 4th quartile. Five year freedom from AAA related complications was 79%, 66%, 58% and 56%, respectively (p = .007). At five years, freedom from neck related events was 86%, 84%, 73%, and 71%, respectively, for the four groups (p = .009), and freedom from iliac related events was 96%, 91%, 88%, and 88%, respectively (p = .335). On multivariable analysis, luminal volume was an independent predictor of late complications (Q4 vs. Q1 - hazard ratio: 1.91, 95% confidence interval 1.01-3.6, p = .046). Overall survival at five years was not affected by lumen volume (p = .75). CONCLUSION: AAA luminal volume represents an important risk factor for AAA related complications. This information may be considered when deciding tailoring surveillance protocols after EVAR. However, larger studies are needed to validate this hypothesis.

Benefit of selective shunt use during carotid endarterectomy under regional anesthesia.

OBJECTIVES: Carotid cross-clamping during endarterectomy exposes the patient to intraoperative neurological deficits due to embolism or cerebral hypoperfusion. To prevent further cerebrovascular incidents, resorting to shunt is frequently recommended. However, since this method is also considered a stroke risk factor, the use is still controversial. This study aims to shed some light on the best approach regarding the use of shunt in symptomatic cerebral malperfusion after carotid artery cross-clamping. METHODS: From January 2012 to January 2018, 79 patients from a tertiary referral hospital who underwent carotid endarterectomy with regional anesthesia for carotid artery stenosis and manifested post-clamping neurologic deficits were prospectively gathered. Shunt use was left to the decision of the surgeon and performed in 31.6% (25) of the patients. Demographics, comorbidities, imaging tests, and clinical/intraoperative features were evaluated. For data assessment, univariate analysis was performed. RESULTS: Regarding 30-day stroke, 30-day postoperative complications (stroke, surgical hematoma, hyperperfusion syndrome), and cranial nerve injury, no significant differences were found (P = 0.301, P = 0.460, and P = 0.301, respectively) between resource to shunt and non-shunt. Clamping and surgery times were significantly higher in the shunt group (P < 0.001 and P = 0.0001, respectively). CONCLUSIONS: Selective-shunting did not demonstrate superiority for patients who developed focal deficits regarding stroke or other postoperative complications. However, due to the limitations of this study, the benefit of shunting cannot be excluded. Further randomized trials are recommended for precise results on this matter with current sparse clinical evidence.

Efficacy of near-infrared spectroscopy cerebral oximetry on detection of critical cerebral perfusion during carotid endarterectomy under regional anesthesia.

Background: Patients undergoing carotid endarterectomy (CEA) may suffer from cerebral hypoperfusion during the carotid cross-clamping. Near-infrared spectroscopy cerebral oximetry (NIRS) is a non-invasive method of regional cerebral oxygen saturation measurement reflecting changes in cerebral blood flow during CEA. The main goal of the study was to evaluate the accuracy of the NIRS in detecting cerebral hypoperfusion during CEA under regional anesthesia (RA) and compare it with awake neurological testing. Patients and methods: A prospective observational study of 28 patients that underwent CEA in RA and manifested neurologic deficits, and 28 consecutive controls from a tertiary and referral center, was performed. All patients were monitored with NIRS cerebral oximetry and awake testing as the control technique. Subsequently, operating characteristic curve and Cohen's kappa coefficient were determined to evaluate the reliability of the monitoring test. Results: NIRS presented a sensitivity of 27.3% and a specificity of 89.3% in comparison to awake testing. Receiver operating characteristic (ROC) curve analysis demonstrated that a decrease of at least 20% in cerebral oxygen saturation is the best threshold to infer cerebral hypoperfusion. However, the respective area under the curve (AUROC) was 0.606 (95% CI: 0.456-0.756, P = 0.178) with a calculated Cohen's kappa of 0.179, P = 0.093. Regarding 30-days outcomes, only awake testing has shown significant associations with stroke and postoperative complications (P = 0.043 and P = 0.05), which were higher in patients with post-clamping neurologic deficits. Conclusions: NIRS demonstrated a reduced discriminative capacity for critical cerebral hypoperfusion, and does not seem to add substantial clinical benefits to the awake test.