Primary results of the brazilian registry of atherothrombotic disease (NEAT).

There is limited contemporary prospective real-world evidence of patients with chronic arterial disease in Latin America. The Network to control atherothrombosis (NEAT) registry is a national prospective observational study of patients with known coronary (CAD) and/or peripheral arterial disease (PAD) in Brazil. A total of 2,005 patients were enrolled among 25 sites from September 2020 to March 2022. Patient characteristics, medications and laboratorial data were collected. Primary objective was to assess the proportion of patients who, at the initial visit, were in accordance with good medical practices (domains) for reducing cardiovascular risk in atherothrombotic disease. From the total of patients enrolled, 2 were excluded since they did not meet eligibility criteria. Among the 2,003 subjects included in the analysis, 55.6% had isolated CAD, 28.7% exclusive PAD and 15.7% had both diagnoses. Overall mean age was 66.3 (± 10.5) years and 65.7% were male patients. Regarding evidence-based therapies (EBTs), 4% were not using any antithrombotic drug and only 1.5% were using vascular dose of rivaroxaban (2.5 mg bid). Only 0.3% of the patients satisfied all the domains of secondary prevention, including prescription of EBTs and targets of body-mass index, blood pressure, LDL-cholesterol, and adherence of lifestyle recommendations. The main barrier for prescription of EBTs was medical judgement. Our findings highlight that the contemporary practice does not reflect a comprehensive approach for secondary prevention and had very low incorporation of new therapies in Brazil. Large-scale populational interventions addressing these gaps are warranted to improve the use of evidence-based therapies and reduce the burden of atherothrombotic disease.ClinicalTrials.gov NCT04677725.

Brazilian guidelines on chronic venous disease of the Brazilian Society of Angiology and Vascular Surgery.

The Brazilian Society of Angiology and Vascular Surgery has set up a committee to provide new evidence-based recommendations for patient care associated with chronic venous insufficiency. Topics were divided in five groups: 1. Classification, 2. Diagnosis, 3. Conservative or non-invasive treatment, 4. Invasive treatment and 5. Treatment of small vessels. This last series is closely related to the activities of Brazilian angiologists and vascular surgeons, who are heavily involved in the treatment of small superficial veins. These guidelines are intended to assist in clinical decision-making for attending physicians and health managers. The decision to follow a guideline recommendation should be made by the responsible physician on a case-by-case basis taking into account the patient's specific condition, as well as local resources, regulations, laws, and clinical practice recommendations.

A Sociedade Brasileira de Angiologia e de Cirurgia Vascular organizou uma comissão para fornecer novas recomendações baseadas em evidências sobre questões críticas de atendimento ao paciente com insuficiência venosa crônica. São abordados aqui os temas de classificação, diagnóstico, tratamento conservador, tratamento invasivo e tratamento de pequenos vasos. Esta última série está muito relacionada à atividade de angiologistas e cirurgiões vasculares, que possuem forte atuação no tratamento de pequenas veias superficiais. Estas diretrizes destinam-se a auxiliar na tomada de decisões clínicas de médicos assistentes e gestores de saúde. A decisão de seguir uma recomendação de diretriz deve ser feita pelo médico responsável caso a caso, levando em consideração a condição específica do paciente, bem como recursos locais, regulamentos, leis e recomendações de prática clínica.

Pharmacological interventions for asymptomatic carotid stenosis.

BACKGROUND: Carotid artery stenosis is narrowing of the carotid arteries. Asymptomatic carotid stenosis is when this narrowing occurs in people without a history or symptoms of this disease. It is caused by atherosclerosis; that is, the build-up of fats, cholesterol, and other substances in and on the artery walls. Atherosclerosis is more likely to occur in people with several risk factors, such as diabetes, hypertension, hyperlipidaemia, and smoking. As this damage can develop without symptoms, the first symptom can be a fatal or disabling stroke, known as ischaemic stroke. Carotid stenosis leading to ischaemic stroke is most common in men older than 70 years. Ischaemic stroke is a worldwide public health problem. OBJECTIVES: To assess the effects of pharmacological interventions for the treatment of asymptomatic carotid stenosis in preventing neurological impairment, ipsilateral major or disabling stroke, death, major bleeding, and other outcomes. SEARCH METHODS: We searched the Cochrane Stroke Group trials register, CENTRAL, MEDLINE, Embase, two other databases, and three trials registers from their inception to 9 August 2022. We also checked the reference lists of any relevant systematic reviews identified and contacted specialists in the field for additional references to trials. SELECTION CRITERIA: We included all randomised controlled trials (RCTs), irrespective of publication status and language, comparing a pharmacological intervention to placebo, no treatment, or another pharmacological intervention for asymptomatic carotid stenosis. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Two review authors independently extracted the data and assessed the risk of bias of the trials. A third author resolved disagreements when necessary. We assessed the evidence certainty for key outcomes using GRADE. MAIN RESULTS: We included 34 RCTs with 11,571 participants. Data for meta-analysis were available from only 22 studies with 6887 participants. The mean follow-up period was 2.5 years. None of the 34 included studies assessed neurological impairment and quality of life. Antiplatelet agent (acetylsalicylic acid) versus placebo Acetylsalicylic acid (1 study, 372 participants) may result in little to no difference in ipsilateral major or disabling stroke (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.47 to 2.47), stroke-related mortality (RR 1.40, 95% CI 0.54 to 3.59), progression of carotid stenosis (RR 1.16, 95% CI 0.79 to 1.71), and adverse events (RR 0.81, 95% CI 0.41 to 1.59), compared to placebo (all low-certainty evidence). The effect of acetylsalicylic acid on major bleeding is very uncertain (RR 0.98, 95% CI 0.06 to 15.53; very low-certainty evidence). The study did not measure neurological impairment or quality of life. Antihypertensive agents (metoprolol and chlorthalidone) versus placebo The antihypertensive agent, metoprolol, may result in no difference in ipsilateral major or disabling stroke (RR 0.14, 95% CI 0.02 to1.16; 1 study, 793 participants) and stroke-related mortality (RR 0.57, 95% CI 0.17 to 1.94; 1 study, 793 participants) compared to placebo (both low-certainty evidence). However, chlorthalidone may slow the progression of carotid stenosis (RR 0.45, 95% CI 0.23 to 0.91; 1 study, 129 participants; low-certainty evidence) compared to placebo. Neither study measured neurological impairment, major bleeding, adverse events, or quality of life. Anticoagulant agent (warfarin) versus placebo The evidence is very uncertain about the effects of warfarin (1 study, 919 participants) on major bleeding (RR 1.19, 95% CI 0.97 to 1.46; very low-certainty evidence), but it may reduce adverse events (RR 0.89, 95% CI 0.81 to 0.99; low-certainty evidence) compared to placebo. The study did not measure neurological impairment, ipsilateral major or disabling stroke, stroke-related mortality, progression of carotid stenosis, or quality of life. Lipid-lowering agents (atorvastatin, fluvastatin, lovastatin, pravastatin, probucol, and rosuvastatin) versus placebo or no treatment Lipid-lowering agents may result in little to no difference in ipsilateral major or disabling stroke (atorvastatin, lovastatin, pravastatin, and rosuvastatin; RR 0.36, 95% CI 0.09 to 1.53; 5 studies, 2235 participants) stroke-related mortality (lovastatin and pravastatin; RR 0.25, 95% CI 0.03 to 2.29; 2 studies, 1366 participants), and adverse events (fluvastatin, lovastatin, pravastatin, probucol, and rosuvastatin; RR 0.76, 95% CI 0.53 to1.10; 7 studies, 3726 participants) compared to placebo or no treatment (all low-certainty evidence). The studies did not measure neurological impairment, major bleeding, progression of carotid stenosis, or quality of life. AUTHORS' CONCLUSIONS: Although there is no high-certainty evidence to support pharmacological intervention, this does not mean that pharmacological treatments are ineffective in preventing ischaemic cerebral events, morbidity, and mortality. High-quality RCTs are needed to better inform the best medical treatment that may reduce the burden of carotid stenosis. In the interim, clinicians will have to use other sources of information.

Prophylactic anticoagulants for non-hospitalised people with COVID-19.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has impacted healthcare systems worldwide. Multiple reports on thromboembolic complications related to COVID-19 have been published, and researchers have described that people with COVID-19 are at high risk for developing venous thromboembolism (VTE). Anticoagulants have been used as pharmacological interventions to prevent arterial and venous thrombosis, and their use in the outpatient setting could potentially reduce the prevalence of vascular thrombosis and associated mortality in people with COVID-19. However, even lower doses used for a prophylactic purpose may result in adverse events such as bleeding. It is important to consider the evidence for anticoagulant use in non-hospitalised people with COVID-19. OBJECTIVES: To evaluate the benefits and harms of prophylactic anticoagulants versus active comparators, placebo or no intervention, or non-pharmacological interventions in non-hospitalised people with COVID-19. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 18 April 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing prophylactic anticoagulants with placebo or no treatment, another active comparator, or non-pharmacological interventions in non-hospitalised people with COVID-19. We included studies that compared anticoagulants with a different dose of the same anticoagulant. We excluded studies with a duration of under two weeks. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Our primary outcomes were all-cause mortality, VTE (deep vein thrombosis (DVT) or pulmonary embolism (PE)), and major bleeding. Our secondary outcomes were DVT, PE, need for hospitalisation, minor bleeding, adverse events, and quality of life. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included five RCTs with up to 90 days of follow-up (short term). Data were available for meta-analysis from 1777 participants. Anticoagulant compared to placebo or no treatment Five studies compared anticoagulants with placebo or no treatment and provided data for three of our outcomes of interest (all-cause mortality, major bleeding, and adverse events). The evidence suggests that prophylactic anticoagulants may lead to little or no difference in all-cause mortality (risk ratio (RR) 0.36, 95% confidence interval (CI) 0.04 to 3.61; 5 studies; 1777 participants; low-certainty evidence) and probably reduce VTE from 3% in the placebo group to 1% in the anticoagulant group (RR 0.36, 95% CI 0.16 to 0.85; 4 studies; 1259 participants; number needed to treat for an additional beneficial outcome (NNTB) = 50; moderate-certainty evidence). There may be little to no difference in major bleeding (RR 0.36, 95% CI 0.01 to 8.78; 5 studies; 1777 participants; low-certainty evidence). Anticoagulants probably result in little or no difference in DVT (RR 1.02, 95% CI 0.30 to 3.46; 3 studies; 1009 participants; moderate-certainty evidence), but probably reduce the risk of PE from 2.7% in the placebo group to 0.7% in the anticoagulant group (RR 0.25, 95% CI 0.08 to 0.79; 3 studies; 1009 participants; NNTB 50; moderate-certainty evidence). Anticoagulants probably lead to little or no difference in reducing hospitalisation (RR 1.01, 95% CI 0.59 to 1.75; 4 studies; 1459 participants; moderate-certainty evidence) and may lead to little or no difference in adverse events (minor bleeding, RR 2.46, 95% CI 0.90 to 6.72; 5 studies, 1777 participants; low-certainty evidence). Anticoagulant compared to a different dose of the same anticoagulant One study compared anticoagulant (higher-dose apixaban) with a different (standard) dose of the same anticoagulant and reported five relevant outcomes. No cases of all-cause mortality, VTE, or major bleeding occurred in either group during the 45-day follow-up (moderate-certainty evidence). Higher-dose apixaban compared to standard-dose apixaban may lead to little or no difference in reducing the need for hospitalisation (RR 1.89, 95% CI 0.17 to 20.58; 1 study; 278 participants; low-certainty evidence) or in the number of adverse events (minor bleeding, RR 0.47, 95% CI 0.09 to 2.54; 1 study; 278 participants; low-certainty evidence). Anticoagulant compared to antiplatelet agent One study compared anticoagulant (apixaban) with antiplatelet agent (aspirin) and reported five relevant outcomes. No cases of all-cause mortality or major bleeding occurred during the 45-day follow-up (moderate-certainty evidence). Apixaban may lead to little or no difference in VTE (RR 0.36, 95% CI 0.01 to 8.65; 1 study; 279 participants; low-certainty evidence), need for hospitalisation (RR 3.20, 95% CI 0.13 to 77.85; 1 study; 279 participants; low-certainty evidence), or adverse events (minor bleeding, RR 2.13, 95% CI 0.40 to 11.46; 1 study; 279 participants; low-certainty evidence). No included studies reported on quality of life or investigated anticoagulants compared to a different anticoagulant, or anticoagulants compared to non-pharmacological interventions. AUTHORS' CONCLUSIONS: We found low- to moderate-certainty evidence from five RCTs that prophylactic anticoagulants result in little or no difference in major bleeding, DVT, need for hospitalisation, or adverse events when compared with placebo or no treatment in non-hospitalised people with COVID-19. Low-certainty evidence indicates that prophylactic anticoagulants may result in little or no difference in all-cause mortality when compared with placebo or no treatment, but moderate-certainty evidence indicates that prophylactic anticoagulants probably reduce the incidence of VTE and PE. Low-certainty evidence suggests that comparing different doses of the same prophylactic anticoagulant may result in little or no difference in need for hospitalisation or adverse events. Prophylactic anticoagulants may result in little or no difference in risk of VTE, hospitalisation, or adverse events when compared with antiplatelet agents (low-certainty evidence). Given that there were only short-term data from one study, these results should be interpreted with caution. Additional trials of sufficient duration are needed to clearly determine any effect on clinical outcomes.

Duplex ultrasound for surveillance of lower limb revascularisation.

BACKGROUND: Lower extremity atherosclerotic disease (LEAD) - also known as peripheral arterial disease - refers to the obstruction or narrowing of the large arteries of the lower limbs, most commonly caused by atheromatous plaque. Although in many cases of less severe disease patients can be asymptomatic, the major clinical manifestations of LEAD are intermittent claudication (IC) and critical limb ischaemia, also known as chronic limb-threatening ischaemia (CLTI). Revascularisation procedures including angioplasty, stenting, and bypass grafting may be required for those in whom the disease is severe or does not improve with non-surgical interventions. Maintaining vessel patency after revascularisation remains a challenge for vascular surgeons, since approximately 30% of vein grafts may present with restenosis in the first year due to myointimal hyperplasia. Restenosis can also occur after angioplasty and stenting. Restenosis and occlusions that occur more than two years after the procedure are generally related to progression of the atherosclerosis. Surveillance programmes with duplex ultrasound (DUS) scanning as part of postoperative care may facilitate early diagnosis of restenosis and help avoid amputation in people who have undergone revascularisation. OBJECTIVES: To assess the effects of DUS versus pulse palpation, arterial pressure index, angiography, or any combination of these, for surveillance of lower limb revascularisation in people with LEAD. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and LILACS databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 February 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that compared DUS surveillance after lower limb revascularisation versus clinical surveillance characterised by medical examination with pulse palpation, with or without any other objective test, such as arterial pressure index measures (e.g. ankle-brachial index (ABI) or toe brachial index (TBI)). Our primary outcomes were limb salvage rate, vessel or graft secondary patency, and adverse events resulting from DUS surveillance. Secondary outcomes were all-cause mortality, functional walking ability assessed by walking distance, clinical severity scales, quality of life (QoL), re-intervention rates, and functional walking ability assessed by any validated walking impairment questionnaire. We presented the outcomes at two time points: two years or less after the original revascularisation (short term) and more than two years after the original revascularisation (long term). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. We used the Cochrane RoB 1 tool to assess the risk of bias for RCTs and GRADE to assess the certainty of evidence. We performed meta-analysis when appropriate. MAIN RESULTS: We included three studies (1092 participants) that compared DUS plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation and arterial pressure index (ABI or TBI) for surveillance of lower limb revascularisation with bypass. One study each was conducted in Sweden and Finland, and the third study was conducted in the UK and Europe. The studies did not report adverse events resulting from DUS surveillance, functional walking ability, or clinical severity scales. No study assessed surveillance with DUS scanning after angioplasty or stenting, or both. We downgraded the certainty of evidence for risk of bias and imprecision. Duplex ultrasound plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation plus arterial pressure index (ABI or TBI) (short-term time point) In the short term, DUS surveillance may lead to little or no difference in limb salvage rate (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.49 to 1.45; I² = 93%; 2 studies, 936 participants; low-certainty evidence) and vein graft secondary patency (RR 0.92, 95% CI 0.67 to 1.26; I² = 57%; 3 studies, 1092 participants; low-certainty evidence). DUS may lead to little or no difference in all-cause mortality (RR 1.11, 95% CI 0.70 to 1.74; 1 study, 594 participants; low-certainty evidence). There was no clear difference in QoL as assessed by the 36-item Short Form Health Survey (SF-36) physical score (mean difference (MD) 2 higher, 95% CI 2.59 lower to 6.59 higher; 1 study, 594 participants; low-certainty evidence); the SF-36 mental score (MD 3 higher, 95% CI 0.38 lower to 6.38 higher; 1 study, 594 participants; low-certainty evidence); or the EQ-5D utility score (MD 0.02 higher, 95% CI 0.03 lower to 0.07 higher; 1 study, 594 participants; low-certainty evidence). DUS may increase re-intervention rates when considered any therapeutic intervention (RR 1.38, 95% CI 1.05 to 1.81; 3 studies, 1092 participants; low-certainty evidence) or angiogram procedures (RR 1.53, 95% CI 1.12 to 2.08; 3 studies, 1092 participants; low-certainty evidence). Duplex ultrasound plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation plus arterial pressure index (ABI or TBI) (long-term time point) One study reported data after two years, but provided only vessel or graft secondary patency data. DUS may lead to little or no difference in vessel or graft secondary patency (RR 0.83, 95% CI 0.19 to 3.51; 1 study, 156 participants; low-certainty evidence). Other outcomes of interest were not reported at the long-term time point. AUTHORS' CONCLUSIONS: Based on low certainty evidence, we found no clear difference between DUS and standard surveillance in preventing limb amputation, morbidity, and mortality after lower limb revascularisation. We found no studies on DUS surveillance after angioplasty or stenting (or both), only studies on bypass grafting. High-quality RCTs should be performed to better inform the best medical surveillance of lower limb revascularisation that may reduce the burden of peripheral arterial disease.

Stenting or angioplasty for the treatment of deep vein thrombosis: Systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Although the cornerstone treatment for deep vein thrombosis (DVT) remains anticoagulation, clinicians perform stenting or angioplasty (SA) in particular patients. To assess the effects of SA in this setting, we performed a systematic review of randomized controlled trials. METHODS: Based on the Cochrane standards, we searched the Cochrane CENTRAL, MEDLINE, Embase, CINAHL, LILACS and IBECS databases, and trial registries. Our primary outcomes were post-thrombotic syndrome (PTS), venous thromboembolism (VTE) and all-cause mortality. RESULTS: We included 7 randomized controlled trial (1485 participants). There was no clinically significant difference between SA and best medical practice (BMP) for the additional treatment of acute DVT regarding PTS (standardized mean difference -7.87, 95% confidence interval [CI] -12.13 to -3.61; very low-certainty) and VTE (risk ratio [RR] 1.19, 95% CI 0.28-5.07, very low-certainty), and no deaths. Compared to BMP, the SA plus BMP and thrombolysis results in little to no difference in PTS (mean difference [MD] -1.07, 95% CI -1.12 to -1.02, moderate-certainty), VTE (RR 1.48, 95% CI 0.95-2.31, low-certainty), and mortality (RR 0.92, 95% CI 0.34-2.52, low-certainty). There was no clinical difference between stenting and BMP for chronic DVT regarding PTS (MD 2.73, 95% CI -2.10 to 7.56, very low certainty) and no VTE and death events. CONCLUSIONS: SA results in little to no difference in PTS, VTE and mortality in acute DVT compared to BMP. The evidence regarding SA in chronic DVT and whether SA, compared to BMP and thrombolysis, decreases PTS and VTE in acute DVT is uncertain. Open Science Framework (osf.io/f2dm6).

Smoking cessation for peripheral arterial disease: systematic review protocol.

BACKGROUND: peripheral arterial disease has smoking as its main avoidable vascular risk factor. However, most studies do not focus on smoking as the main exposure variable. OBJECTIVES: to assess the impact of smoking cessation interventions versus active comparator, placebo or no intervention, on peripheral arterial disease outcomes. METHODS: we will use the Cochrane Handbook for Systematic Reviews of Interventions to guide whole this review process. We will consider parallel or cluster-randomised controlled trials (RCTs), quasi-RCTs, and cohort studies. We will search CENTRAL, MEDLINE, Embase, PsycINFO, LILACS and IBECS. We will also conduct a search of ClinicalTrials.gov and the ICTRP for ongoing or unpublished trials. Each research step will involve at least two independent reviewers. We will create a table, using GRADE pro GDT software, reporting the pooled effect estimates for the following outcomes: all-cause mortality, lower limb amputation, adverse events, walking distance, clinical severity, vessel or graft secondary patency, and QoL. CONCLUSIONS: we will assess these outcomes according to the five GRADE considerations to assess the certainty of the body of evidence for these outcomes, and to draw conclusions about the certainty of the evidence within the review.

Brazilian guidelines on chronic venous disease of the Brazilian Society of Angiology and Vascular Surgery / Diretriz brasileira de doença venosa crônica da Sociedade Brasileira de Angiologia e de Cirurgia Vascular

Abstract The Brazilian Society of Angiology and Vascular Surgery has set up a committee to provide new evidence-based recommendations for patient care associated with chronic venous insufficiency. Topics were divided in five groups: 1. Classification, 2. Diagnosis, 3. Conservative or non-invasive treatment, 4. Invasive treatment and 5. Treatment of small vessels. This last series is closely related to the activities of Brazilian angiologists and vascular surgeons, who are heavily involved in the treatment of small superficial veins. These guidelines are intended to assist in clinical decision-making for attending physicians and health managers. The decision to follow a guideline recommendation should be made by the responsible physician on a case-by-case basis taking into account the patient's specific condition, as well as local resources, regulations, laws, and clinical practice recommendations.

Resumo A Sociedade Brasileira de Angiologia e de Cirurgia Vascular organizou uma comissão para fornecer novas recomendações baseadas em evidências sobre questões críticas de atendimento ao paciente com insuficiência venosa crônica. São abordados aqui os temas de classificação, diagnóstico, tratamento conservador, tratamento invasivo e tratamento de pequenos vasos. Esta última série está muito relacionada à atividade de angiologistas e cirurgiões vasculares, que possuem forte atuação no tratamento de pequenas veias superficiais. Estas diretrizes destinam-se a auxiliar na tomada de decisões clínicas de médicos assistentes e gestores de saúde. A decisão de seguir uma recomendação de diretriz deve ser feita pelo médico responsável caso a caso, levando em consideração a condição específica do paciente, bem como recursos locais, regulamentos, leis e recomendações de prática clínica.

Smoking cessation for peripheral arterial disease: systematic review protocol / Cessação do tabagismo para doença arterial periférica: protocolo de revisão sistemática

ABSTRACT Background: peripheral arterial disease has smoking as its main avoidable vascular risk factor. However, most studies do not focus on smoking as the main exposure variable. Objectives: to assess the impact of smoking cessation interventions versus active comparator, placebo or no intervention, on peripheral arterial disease outcomes. Methods: we will use the Cochrane Handbook for Systematic Reviews of Interventions to guide whole this review process. We will consider parallel or cluster-randomised controlled trials (RCTs), quasi-RCTs, and cohort studies. We will search CENTRAL, MEDLINE, Embase, PsycINFO, LILACS and IBECS. We will also conduct a search of ClinicalTrials.gov and the ICTRP for ongoing or unpublished trials. Each research step will involve at least two independent reviewers. We will create a table, using GRADE pro GDT software, reporting the pooled effect estimates for the following outcomes: all-cause mortality, lower limb amputation, adverse events, walking distance, clinical severity, vessel or graft secondary patency, and QoL. Conclusions: we will assess these outcomes according to the five GRADE considerations to assess the certainty of the body of evidence for these outcomes, and to draw conclusions about the certainty of the evidence within the review.

RESUMO Introdução: a doença arterial periférica tem o tabagismo como principal fator de risco vascular evitável. Entretanto, a maioria dos estudos não destaca o tabagismo como principal variável de exposição. Objetivos: avaliar o impacto das intervenções de cessação do tabagismo versus comparador ativo, placebo ou nenhuma intervenção, nos desfechos da doença arterial periférica. Métodos: usaremos o Cochrane Handbook for Systematic Review of Interventions para orientar todo este processo de revisão. Consideraremos ensaios controlados paralelos ou randomizados por cluster (ECRs), quase-ECRs e estudos de coorte. Buscaremos no CENTRAL, MEDLINE, Embase, PsycINFO, LILACS e IBECS. ClinicalTrials.gov e ICTRP serão consultados para ensaios em andamento ou não publicados. Criaremos uma tabela, usando o software GRADE pro GDT, relatando as estimativas de efeito agrupado para os seguintes desfechos: mortalidade por todas as causas, amputação de membro inferior, eventos adversos, distância percorrida, gravidade clínica, permeabilidade secundária do vaso ou enxerto e qualidade de vida. Avaliaremos esses resultados de acordo com as cinco considerações GRADE para avaliar a certeza do corpo de evidências para esses resultados e tirar conclusões sobre a certeza das evidências na revisão.

Vascular complications in 305 severely ill patients with COVID-19: a cohort study

ABSTRACT BACKGROUND: Although an association has been made between coronavirus disease 2019 (COVID-19) and microvascular disease, data on vascular complications (other than venous thromboembolism) are sparse. OBJECTIVE: To investigate the vascular complications in severely ill patients hospitalized with COVID-19 and their association with all-cause mortality. DESIGN AND SETTING: This cohort study was conducted at the Universidade Federal de São Paulo, Brazil. METHODS: All 305 consecutive patients diagnosed with COVID-19 and hospitalized in the intensive care unit (ICU) of a tertiary university hospital from April 2 to July 17, 2021, were included and followed up for 30 days. RESULTS: Of these, 193 (63.3%) were male, and the mean age was 59.9 years (standard deviation = 14.34). The mortality rate was 56.3% (172 patients), and 72 (23.6%) patients developed at least one vascular complication during the follow-up period. Vascular complications were more prevalent in the non-survivors (28.5%) than in the survivors (17.3%) group and included disseminated intravascular coagulation (DIC, 10.8%), deep vein thrombosis (8.2%), acrocyanosis (7.5%), and necrosis of the extremities (2%). DIC (adjusted odds ratio (aOR) 2.30, 95% confidence interval (CI) 1.01-5.24, P = 0.046) and acrocyanosis (aOR 5.21, 95% CI 1.48-18.27, P = 0.009) were significantly more prevalent in the non-survivors than in the survivors group. CONCLUSION: Vascular complications in critically ill COVID-19 patients are common (23.6%) and can be closely related to the mortality rate (56.3%) until 30 days after ICU admission. Macrovascular complications have direct implications for mortality, which is the main outcome of the management of COVID-19. REGISTRATION: RBR-4qjzh7 (https://ensaiosclinicos.gov.br/rg/RBR-4qjzh7).

Vascular complications in 305 severely ill patients with COVID-19: a cohort study.

BACKGROUND: Although an association has been made between coronavirus disease 2019 (COVID-19) and microvascular disease, data on vascular complications (other than venous thromboembolism) are sparse. OBJECTIVE: To investigate the vascular complications in severely ill patients hospitalized with COVID-19 and their association with all-cause mortality. DESIGN AND SETTING: This cohort study was conducted at the Universidade Federal de São Paulo, Brazil. METHODS: All 305 consecutive patients diagnosed with COVID-19 and hospitalized in the intensive care unit (ICU) of a tertiary university hospital from April 2 to July 17, 2021, were included and followed up for 30 days. RESULTS: Of these, 193 (63.3%) were male, and the mean age was 59.9 years (standard deviation = 14.34). The mortality rate was 56.3% (172 patients), and 72 (23.6%) patients developed at least one vascular complication during the follow-up period. Vascular complications were more prevalent in the non-survivors (28.5%) than in the survivors (17.3%) group and included disseminated intravascular coagulation (DIC, 10.8%), deep vein thrombosis (8.2%), acrocyanosis (7.5%), and necrosis of the extremities (2%). DIC (adjusted odds ratio (aOR) 2.30, 95% confidence interval (CI) 1.01-5.24, P = 0.046) and acrocyanosis (aOR 5.21, 95% CI 1.48-18.27, P = 0.009) were significantly more prevalent in the non-survivors than in the survivors group. CONCLUSION: Vascular complications in critically ill COVID-19 patients are common (23.6%) and can be closely related to the mortality rate (56.3%) until 30 days after ICU admission. Macrovascular complications have direct implications for mortality, which is the main outcome of the management of COVID-19. REGISTRATION: RBR-4qjzh7 (https://ensaiosclinicos.gov.br/rg/RBR-4qjzh7).

Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery.

BACKGROUND: Venous thromboembolism (VTE), which comprises deep vein thrombosis (DVT) and pulmonary embolism (PE), is the leading cause of preventable death in hospitalised people and the third most common cause of mortality in surgical patients. People undergoing bariatric surgery have the additional risk factor of being overweight. Although VTE prophylaxis in surgical patients is well established, the best way to prevent VTE in those undergoing bariatric surgery is less clear. OBJECTIVES: To evaluate the benefits and harms of pharmacological interventions (alone or in combination) on venous thromboembolism and other health outcomes in people undergoing bariatric surgery compared to the same pharmacological intervention administered at a different dose or frequency, the same pharmacological intervention or started at a different time point, another pharmacological intervention, no intervention or placebo. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 1 November 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs in males and females of any age undergoing bariatric surgery comparing pharmacological interventions for VTE (alone or in combination) with the same pharmacological intervention administered at a different dose or frequency, the same pharmacological intervention started at a different time point, a different pharmacological intervention, no treatment or placebo. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. VTE and 2. major bleeding. Our secondary outcomes were 1. all-cause mortality, 2. VTE-related mortality, 3. PE, 4. DVT, 5. adverse effects and 6. quality of life. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We included seven RCTs with 1045 participants. Data for meta-analysis were available from all participants. Four RCTs (597 participants) compared higher-dose heparin to standard-dose heparin: one of these studies (139 participants) used unfractionated heparin (UFH) and the other three (458 participants) used low-molecular-weight heparin (LMWH). One study compared heparin versus pentasaccharide (198 participants), and one study compared starting heparin before versus after bariatric surgery (100 participants). One study (150 participants) compared combined mechanical and pharmacological (enoxaparin) prophylaxis versus mechanical prophylaxis alone. The duration of the interventions ranged from seven to 15 days, and follow-up ranged from 10 to 180 days. Higher-dose heparin versus standard-dose heparin Compared to standard-dose heparin, higher-dose heparin may result in little or no difference in the risk of VTE (RR 0.55, 95% CI 0.05 to 5.99; 4 studies, 597 participants) or major bleeding (RR 1.19, 95% CI 0.48 to 2.96; I2 = 8%; 4 studies, 597 participants; low-certainty) in people undergoing bariatric surgery. The evidence on all-cause mortality, VTE-related mortality, PE, DVT and adverse events (thrombocytopenia) is uncertain (effect not estimable or very low-certainty evidence). Heparin versus pentasaccharide Heparin compared to a pentasaccharide after bariatric surgery may result in little or no difference in the risk of VTE (RR 0.83, 95% CI 0.19 to 3.61; 1 study, 175 participants) or DVT (RR 0.83, 95% CI 0.19 to 3.61; 1 study, 175 participants). The evidence on major bleeding, PE and mortality is uncertain (effect not estimable or very low-certainty evidence). Heparin started before versus after the surgical procedure Starting prophylaxis with heparin 12 hours before surgery versus after surgery may result in little or no difference in the risk of VTE (RR 0.11, 95% CI 0.01 to 2.01; 1 study, 100 participants) or DVT (RR 0.11, 95% CI 0.01 to 2.01; 1 study, 100 participants). The evidence on major bleeding, all-cause mortality and VTE-related mortality is uncertain (effect not estimable or very low-certainty evidence). We were unable to assess the effect of this intervention on PE or adverse effects, as the study did not measure these outcomes. Combined mechanical and pharmacological prophylaxis versus mechanical prophylaxis alone Combining mechanical and pharmacological prophylaxis (started 12 hours before surgery) may reduce VTE events in people undergoing bariatric surgery compared to mechanical prophylaxis alone (RR 0.05, 95% CI 0.00 to 0.89; number needed to treat for an additional beneficial outcome (NNTB) = 9; 1 study, 150 participants; low-certainty). We were unable to assess the effect of this intervention on major bleeding or morality (effect not estimable), or on PE or adverse events (not measured). No studies measured quality of life. AUTHORS' CONCLUSIONS: Higher-dose heparin may make little or no difference to venous thromboembolism or major bleeding in people undergoing bariatric surgery when compared to standard-dose heparin. Heparin may make little or no difference to venous thromboembolism in people undergoing bariatric surgery when compared to pentasaccharide. There are inadequate data to draw conclusions about the effects of heparin compared to pentasaccharide on major bleeding. Starting prophylaxis with heparin 12 hours before bariatric surgery may make little or no difference to venous thromboembolism in people undergoing bariatric surgery when compared to starting heparin after bariatric surgery. There are inadequate data to draw conclusions about the effects of heparin started before versus after surgery on major bleeding. Combining mechanical and pharmacological prophylaxis (started 12 hours before surgery) may reduce VTE events in people undergoing bariatric surgery when compared to mechanical prophylaxis alone. No data are available relating to major bleeding. The certainty of the evidence is limited by small sample sizes, few or no events, and risk of bias concerns. Future trials must be sufficiently large to enable analysis of relevant clinical outcomes, and should standardise the time of treatment and follow-up. They should also address the effect of direct oral anticoagulants and antiplatelets, preferably grouping them according to the type of intervention.

Duplex ultrasound for diagnosing symptomatic carotid stenosis in the extracranial segments.

BACKGROUND: Carotid artery stenosis is an important cause of stroke and transient ischemic attack. Correctly and rapidly identifying patients with symptomatic carotid artery stenosis is essential for adequate treatment with early cerebral revascularization. Doubts about the diagnostic value regarding the accuracy of duplex ultrasound (DUS) and the possibility of using DUS as the single diagnostic test before carotid revascularization are still debated. OBJECTIVES: To estimate the accuracy of DUS in individuals with symptomatic carotid stenosis verified by either digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA). SEARCH METHODS: We searched CRDTAS, CENTRAL, MEDLINE (Ovid), Embase (Ovid), ISI Web of Science, HTA, DARE, and LILACS up to 15 February 2021. We handsearched the reference lists of all included studies and other relevant publications and contacted experts in the field to identify additional studies or unpublished data. SELECTION CRITERIA: We included studies assessing DUS accuracy against an acceptable reference standard (DSA, MRA, or CTA) in symptomatic patients. We considered the classification of carotid stenosis with DUS defined with validated duplex velocity criteria, and the NASCET criteria for carotid stenosis measures on DSA, MRA, and CTA. We excluded studies that included < 70% of symptomatic patients; the time between the index test and the reference standard was longer than four weeks or not described, or that presented no objective criteria to estimate carotid stenosis. DATA COLLECTION AND ANALYSIS: The review authors independently screened articles, extracted data, and assessed the risk of bias and applicability concerns using the QUADAS-2 domain list. We extracted data with an effort to complete a 2 × 2 table (true positives, true negatives, false positives, and false negatives) for each of the different categories of carotid stenosis and reference standards. We produced forest plots and summary receiver operating characteristic (ROC) plots to summarize the data. Where meta-analysis was possible, we used a bivariate meta-analysis model. MAIN RESULTS: We identified 25,087 unique studies, of which 22 were deemed eligible for inclusion (4957 carotid arteries). The risk of bias varied considerably across the studies, and studies were generally of moderate to low quality. We narratively described the results without meta-analysis in seven studies in which the criteria used to determine stenosis were too different from the duplex velocity criteria proposed in our protocol or studies that provided insufficient data to complete a 2 × 2 table for at least in one category of stenosis. Nine studies (2770 carotid arteries) presented DUS versus DSA results for 70% to 99% carotid artery stenosis, and two (685 carotid arteries) presented results from DUS versus CTA in this category. Seven studies presented results for occlusion with DSA as the reference standard and three with CTA as the reference standard. Five studies compared DUS versus DSA for 50% to 99% carotid artery stenosis. Only one study presented results from 50% to 69% carotid artery stenosis. For DUS versus DSA, for < 50% carotid artery stenosis, the summary sensitivity was 0.63 (95% confidence interval [CI] 0.48 to 0.76) and the summary specificity was 0.99 (95% CI 0.96 to 0.99); for the 50% to 69% range, only one study was included and meta-analysis not performed; for the 50% to 99% range, the summary sensitivity was 0.97 (95% CI 0.95 to 0.98) and the summary specificity was 0.70 (95% CI 0.67 to 0.73); for the 70% to 99% range, the summary sensitivity was 0.85 (95% CI 0.77 to 0.91) and the summary specificity was 0.98 (95% CI 0.74 to 0.90); for occlusion, the summary sensitivity was 0.91 (95% CI 0.81 to 0.97) and the summary specificity was 0.95 (95% CI 0.76 to 0.99). For sensitivity analyses, excluding studies in which participants were selected based on the presence of occlusion on DUS had an impact on specificity: 0.98 (95% CI 0.97 to 0.99). For DUS versus CTA, we found two studies in the range of 70% to 99%; the sensitivity varied from 0.57 to 0.94 and the specificity varied from 0.87 to 0.98. For occlusion, the summary sensitivity was 0.95 (95% CI 0.80 to 0.99) and the summary specificity was 0.91 (95% CI 0.09 to 0.99). For DUS versus MRA, there was one study with results for 50% to 99% carotid artery stenosis, with a sensitivity of 0.88 (95% CI 0.70 to 0.98) and specificity of 0.60 (95% CI 0.15 to 0.95); in the 70% to 99% range, two studies were included, with sensitivity that varied from 0.54 to 0.99 and specificity that varied from 0.78 to 0.89. We could perform only a few of the proposed sensitivity analyses because of the small number of studies included. AUTHORS' CONCLUSIONS: This review provides evidence that the diagnostic accuracy of DUS is high, especially at discriminating between the presence or absence of significant carotid artery stenosis (< 50% or 50% to 99%). This evidence, plus its less invasive nature, supports the early use of DUS for the detection of carotid artery stenosis. The accuracy for 70% to 99% carotid artery stenosis and occlusion is high. Clinicians should exercise caution when using DUS as the single preoperative diagnostic method, and the limitations should be considered. There was little evidence of the accuracy of DUS when compared with CTA or MRA. The results of this review should be interpreted with caution because they are based on studies of low methodological quality, mainly due to the patient selection method. Methodological problems in participant inclusion criteria from the studies discussed above apparently influenced an overestimated estimate of prevalence values. Most of the studies included failed to precisely describe inclusion criteria and previous testing. Future diagnostic accuracy studies should include direct comparisons of the various modalities of diagnostic tests (mainly DUS, CTA, and MRA) for carotid artery stenosis since DSA is no longer considered to be the best method for diagnosing carotid stenosis and less invasive tests are now used as reference standards in clinical practice. Also, for future studies, the participant inclusion criteria require careful attention.

Antiplatelet agents for the treatment of deep venous thrombosis.

BACKGROUND: Antiplatelet agents may be useful for the treatment of deep venous thrombosis (DVT) when used in addition to best medical practice (BMP), which includes anticoagulation, compression stockings, and clinical care such as physical exercise, skin hydration, etc. Antiplatelet agents could minimise complications such as post-thrombotic syndrome (PTS) and pulmonary embolism (PE). They may also reduce the recurrence of the disease (recurrent venous thromboembolism (recurrent VTE)). However, antiplatelet agents may increase the likelihood of bleeding events. OBJECTIVES: To assess the effects of antiplatelet agents in addition to current BMP compared to current BMP (with or without placebo) for the treatment of DVT. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 7 December 2021. The review authors searched LILACS and IBECS databases (15 December 2021) and also checked the bibliographies of included trials for further references to relevant trials, and contacted specialists in the field, manufacturers and authors of the included trials. SELECTION CRITERIA: We considered randomised controlled trials (RCTs) examining antiplatelet agents compared to BMP following initial standard anticoagulation treatment for DVT. We included studies where antiplatelet agents were given in addition to current BMP compared to current BMP (with or without placebo) for the treatment of DVT (acute: treatment started within 21 days of symptom onset; chronic: treatment started after 21 days of symptom onset). We evaluated only RCTs where the antiplatelet agents were the unique difference between the groups (intervention and control). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Two review authors independently extracted data and assessed risk of bias of the trials. Any disagreements were resolved by discussion with a third review author. We calculated outcome effects using risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) and the number needed to treat to benefit (NNTB). MAIN RESULTS: We included six studies with 1625 eligible participants, with data up to 37.2 months of follow-up. For one preplanned comparison (i.e. antiplatelet agents plus BMP versus BMP plus placebo) for acute DVT we identified no eligible studies for inclusion. In acute DVT, antiplatelet agents plus BMP versus BMP alone was assessed by one study (500 participants), which reported on four outcomes until 6 months of follow-up. There were no deaths and no cases of major bleeding reported. The participants who received antiplatelet agents showed a lower risk of PTS (RR 0.74, 95% CI 0.61 to 0.91; 1 study, 500 participants; very low-certainty evidence). The control group presented a lower risk of adverse events compared to the intervention group (RR 2.88, 95% CI 1.06 to 7.80; 1 study, 500 participants; very low-certainty evidence). This study did not provide information for recurrent VTE or PE. In chronic DVT, antiplatelet agents plus BMP versus BMP alone was assessed by one study (224 participants). The study authors reported four relevant outcomes, three of which (major bleeding, mortality and adverse events) showed no events during the 3 years of follow-up. Therefore, an effect estimate could only be reported for recurrent VTE, favouring antiplatelet agents plus BMP versus BMP alone (RR 0.12, 95% CI 0.05 to 0.34; 1 study, 224 participants; very low-certainty evidence). For the outcomes PE and PTS, this study did not present information which could be used for analysis. In chronic DVT, antiplatelet agents plus BMP versus BMP plus placebo was assessed by four studies (901 participants). The meta-analysis of this pooled data showed a lower risk of recurrent VTE for the antiplatelet agents group (RR 0.65, 95%, CI 0.43 to 0.96; NNTB = 14; low-certainty evidence). For major bleeding, we found no clear difference between placebo and intervention groups until 37.2 months of follow-up (RR 0.98, 95% CI 0.29 to 3.34; 1 study, 583 participants; moderate-certainty evidence). In PE fatal/non-fatal outcome, we found no clear difference with the use of antiplatelet agents (RR 0.52, 95% CI 0.23 to 1.14; 1 study, 583 participants; moderate-certainty evidence). For all-cause mortality, the overall effect of antiplatelet agents did not differ from the placebo group (RR 0.48, 95% CI 0.21 to 1.06; 3 studies, 649 participants; moderate-certainty evidence). The adverse events outcome did not show a clear difference (RR 1.57, 95% CI 0.34 to 7.19; 2 studies, 621 participants; moderate-certainty evidence). There is no assessment of PTS in these studies. We downgraded the certainty of evidence for risk of bias, indirectness, imprecision and publication bias. AUTHORS' CONCLUSIONS: In chronic DVT settings, following the initial standard treatment with anticoagulants, there is low-certainty evidence that antiplatelet agents in addition to BMP may reduce recurrent VTE, (NNTB = 14) when compared to BMP plus placebo. Moderate-certainty evidence shows no clear difference in adverse events, major bleeding and PE when antiplatelet agents are used in addition to BMP compared to BMP plus placebo. In acute and chronic DVT settings, following the initial standard treatment with anticoagulants, we can draw no conclusions for antiplatelet agents in addition to BMP compared to BMP alone due to very low-certainty evidence.  Trials of high methodological quality, that are large and of sufficient duration to detect significant clinical outcomes are needed. Trials should ideally last more than 4 years in order to estimate the long-term effect of antiplatelet agents. Trials should include people with acute and chronic DVT and provide relevant individual data, such as the outcome for each index event (DVT or PE), the use of an inferior vena cava (IVC) filter, whether the DVT is provoked or unprovoked, and the age of participants.

Type of anaesthesia for acute ischaemic stroke endovascular treatment.

BACKGROUND: The use of mechanical thrombectomy to restore intracranial blood flow after proximal large artery occlusion by a thrombus has increased over time and led to better outcomes than intravenous thrombolytic therapy alone. Currently, the type of anaesthetic technique during mechanical thrombectomy is under debate as having a relevant impact on neurological outcomes. OBJECTIVES: To assess the effects of different types of anaesthesia for endovascular interventions in people with acute ischaemic stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Specialised Register of Trials on 5 July 2022, and CENTRAL, MEDLINE, and seven other databases on 21 March 2022. We performed searches of reference lists of included trials, grey literature sources, and other systematic reviews.  SELECTION CRITERIA: We included all randomised controlled trials with a parallel design that compared general anaesthesia versus local anaesthesia, conscious sedation anaesthesia, or monitored care anaesthesia for mechanical thrombectomy in acute ischaemic stroke. We also included studies reported as full-text, those published as abstract only, and unpublished data. We excluded quasi-randomised trials, studies without a comparator group, and studies with a retrospective design. DATA COLLECTION AND ANALYSIS: Two review authors independently applied the inclusion criteria, extracted data, and assessed the risk of bias and the certainty of the evidence using the GRADE approach. The outcomes were assessed at different time periods, ranging from the onset of the stroke symptoms to 90 days after the start of the intervention. The main outcomes were functional outcome, neurological impairment, stroke-related mortality, all intracranial haemorrhage, target artery revascularisation status, time to revascularisation, adverse events, and quality of life. All included studies reported data for early (up to 30 days) and long-term (above 30 days) time points. MAIN RESULTS: We included seven trials with 982 participants, which investigated the type of anaesthesia for endovascular treatment in large vessel occlusion in the intracranial circulation. The outcomes were assessed at different time periods, ranging from the onset of stroke symptoms to 90 days after the procedure. Therefore, all included studies reported data for early (up to 30 days) and long-term (above 30 up to 90 days) time points. General anaesthesia versus non-general anaesthesia(early) We are uncertain about the effect of general anaesthesia on functional outcomes compared to non-general anaesthesia (mean difference (MD) 0, 95% confidence interval (CI) -0.31 to 0.31; P = 1.0; 1 study, 90 participants; very low-certainty evidence) and in time to revascularisation from groin puncture until the arterial reperfusion (MD 2.91 minutes, 95% CI -5.11 to 10.92; P = 0.48; I² = 48%; 5 studies, 498 participants; very low-certainty evidence). General anaesthesia may lead to no difference in neurological impairment up to 48 hours after the procedure (MD -0.29, 95% CI -1.18 to 0.59; P = 0.52; I² = 0%; 7 studies, 982 participants; low-certainty evidence), and in stroke-related mortality (risk ratio (RR) 0.98, 95% CI 0.52 to 1.84; P = 0.94; I² = 0%; 3 studies, 330 participants; low-certainty evidence), all intracranial haemorrhages (RR 0.92, 95% CI 0.65 to 1.29; P = 0.63; I² = 0%; 5 studies, 693 participants; low-certainty evidence) compared to non-general anaesthesia. General anaesthesia may improve adverse events (haemodynamic instability) compared to non-general anaesthesia (RR 0.21, 95% CI 0.05 to 0.79; P = 0.02; I² = 71%; 2 studies, 229 participants; low-certainty evidence). General anaesthesia improves target artery revascularisation compared to non-general anaesthesia (RR 1.10, 95% CI 1.02 to 1.18; P = 0.02; I² = 29%; 7 studies, 982 participants; moderate-certainty evidence). There were no available data for quality of life. General anaesthesia versus non-general anaesthesia (long-term) There is no difference in general anaesthesia compared to non-general anaesthesia for dichotomous and continuous functional outcomes (dichotomous: RR 1.21, 95% CI 0.93 to 1.58; P = 0.16; I² = 29%; 4 studies, 625 participants; low-certainty evidence; continuous: MD -0.14, 95% CI -0.34 to 0.06; P = 0.17; I² = 0%; 7 studies, 978 participants; low-certainty evidence). General anaesthesia showed no changes in stroke-related mortality compared to non-general anaesthesia (RR 0.88, 95% CI 0.64 to 1.22; P = 0.44; I² = 12%; 6 studies, 843 participants; low-certainty evidence). There were no available data for neurological impairment, all intracranial haemorrhages, target artery revascularisation status, time to revascularisation from groin puncture until the arterial reperfusion, adverse events (haemodynamic instability), or quality of life. Ongoing studies We identified eight ongoing studies. Five studies compared general anaesthesia versus conscious sedation anaesthesia, one study compared general anaesthesia versus conscious sedation anaesthesia plus local anaesthesia, and two studies compared general anaesthesia versus local anaesthesia. Of these studies, seven plan to report data on functional outcomes using the modified Rankin Scale, five studies on neurological impairment, six studies on stroke-related mortality, two studies on all intracranial haemorrhage, five studies on target artery revascularisation status, four studies on time to revascularisation, and four studies on adverse events. One ongoing study plans to report data on quality of life. One study did not plan to report any outcome of interest for this review. AUTHORS' CONCLUSIONS: In early outcomes, general anaesthesia improves target artery revascularisation compared to non-general anaesthesia with moderate-certainty evidence. General anaesthesia may improve adverse events (haemodynamic instability) compared to non-general anaesthesia with low-certainty evidence. We found no evidence of a difference in neurological impairment, stroke-related mortality, all intracranial haemorrhage and haemodynamic instability adverse events between groups with low-certainty evidence. We are uncertain whether general anaesthesia improves functional outcomes and time to revascularisation because the certainty of the evidence is very low. However, regarding long-term outcomes, general anaesthesia makes no difference to functional outcomes compared to non-general anaesthesia with low-certainty evidence. General anaesthesia did not change stroke-related mortality when compared to non-general anaesthesia with low-certainty evidence. There were no reported data for other outcomes. In view of the limited evidence of effect, more randomised controlled trials with a large number of participants and good protocol design with a low risk of bias should be performed to reduce our uncertainty and to aid decision-making in the choice of anaesthesia.

Carotid Plaque Composition and the Importance of Non-Invasive in Imaging Stroke Prevention.

Luminal stenosis has been the standard feature for the current management strategies in patients with atherosclerotic carotid disease. Histological and imaging studies show considerable differences between plaques with identical degrees of stenosis. They indicate that specific plaque characteristics like Intraplaque hemorrhage, Lipid Rich Necrotic Core, Plaque Inflammation, Thickness and Ulceration are responsible for the increased risk of ischemic events. Intraplaque hemorrhage is defined by the accumulation of blood components within the plaque, Lipid Rich Necrotic Core is composed of macrophages loaded with lipid, Plaque Inflammation is defined as the process of atherosclerosis itself and Plaque thickness and Ulceration are defined as morphological features. Advances in imaging methods like Magnetic Resonance Imaging, Ultrasound, Computed Tomography and Positron Emission Tomography have enabled a more detailed characterization of the plaque, and its vulnerability is linked to these characteristics, changing the management of these patients based only on the degree of plaque stenosis. Studies like Rotterdam, ARIC, PARISK, CAPIAS and BIOVASC were essential to evaluate and prove the relevance of these characteristics with cerebrovascular symptoms. A better approach for the prevention of stroke is needed. This review summarizes the more frequent carotid plaque features and the available validation from recent studies with the latest evidence.

External validation of Villalta score in high-middle income country patients with deep vein thrombosis.

ABSTRACT: Post-thrombotic syndrome (PTS) is a late complication that does not have a cure yet, with a prevalence estimated between 20 to 75%, associated with previous deep vein thrombosis event. Although the Villalta score (VS) is the gold-standard clinical tool for diagnostic and prognostic evaluation of PTS, there are currently no VS intra-rater agreement established and no validation studies for VS' application into Brazilian Portuguese. We sought to translate and validate VS reliability systematically; and, secondarily, to compare the ultrasound findings with the severity of PTS.We systematically translated the original VS into Brazilian Portuguese (BP). Fifty participants who underwent two outpatient visits were evaluated using the translated VS. We assessed its intra-rater and inter-rater agreement and compared BP VS versus CEAP clinical component (CEAP C), and the clinical PTS severity versus the duplex ultrasound (DUS) findings. The study and its report followed the Guidelines for Reporting Reliability and Agreement Studies.The intra-rater evaluation of VS grades had a simple Kappa coefficient of 0.73, and the simple Kappa coefficient inter-rater for VS grades was 0.67. When VS was compared to CEAP C, it established a remarkably high correlation over 0.9. There was difference among VS values compared to DUS initial deep vein thrombosis territory, with femoropopliteal showing higher values than distal veins. Higher VS values were correlated to DUS venous recanalization and reflux.There was a substantial inter-rater and intra-rater agreement when the BP VS was applied; and when compared to CEAP C, VS showed a high correlation. When VS grading was compared to DUS characteristics, there were significant statistical and clinical correlation, with presence of reflux and recanalization showing higher VS values. This external VS validation also changes the clinical practice allowing the VS use in a different population and establishes the VS intra-rater agreement.

Ventilatory weaning strategies for predicting extubation success in children following cardiac surgery for congenital heart disease: a protocol for a systematic review and meta-analysis.

INTRODUCTION: Congenital heart disease (CHD) comprises the anatomic malformations that jeopardise the structure and function of the heart. It can be extremely complex and serious, corresponding to 30% of all deaths in the first month of life. The surgical approach for adequate treatment requires postoperative mechanical ventilation. The most critical decision related to the postoperative management of patients submitted to cardiac surgery is the right time for extubation, especially because not only abrupt or inadequate discontinuation of ventilatory support can lead to clinical decline and necessity of reintubation but also extended time of mechanical ventilation, which can lead to complications, such as pneumonia, atelectasis, diaphragm hypertrophy, and increasing morbidity and mortality. METHODS AND ANALYSIS: This systematic review plans to include individual parallel, cross-over and cluster randomised controlled trials regarding any breathing trial test to predict extubation success in children submitted to cardiac surgery due to CHD. Studies with paediatric patients submitted to cardiac surgery for congenital cardiopathy repair, attended at a critical care unit, and under mechanical ventilatory support will be included. The main outcomes analysed will be success of extubation, reduction of pulmonary complications and time reduction of mechanical ventilation. ETHICS AND DISSEMINATION: We will not treat patients directly; therefore, ethics committee approval was not necessary because it is not a primary study. We expect that this study may improve healthcare and medical assistance, helping healthcare professionals with routine daily decisions regarding the correct time for extubation. PROSPERO REGISTRATION NUMBER: CRD42021223999.