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BACKGROUND: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. STUDY DESIGN: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. SUMMARY: This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.
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Angioplastia , Aspirina/uso terapêutico , Clopidogrel/uso terapêutico , Isquemia/cirurgia , Perna (Membro)/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Inibidores da Agregação Plaquetária/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Trombose/prevenção & controle , Angioplastia/métodos , Estado Terminal , Inibidores do Fator Xa , Humanos , Estudos Multicêntricos como Assunto , Artéria Poplítea , Estudo de Prova de Conceito , Estudos ProspectivosRESUMO
INTRODUCTION: Internal carotid artery (ICA) stenosis causes about 15% of ischemic strokes. Duplex ultrasonography (DUS) is the first line of investigation of ICA stenosis, but its accuracy varies in the literature and it is usual to complement the study with another more accurate exam when faced with significant stenosis. There is a lack of studies that compare DUS with angiotomography (CTA) in the present literature. METHODS: we performed an accuracy study, which compared DUS to CTA of patients in a tertiary hospital with a maximum interval of three months between tests. Patients were selected retrospectively, and two independent and certified vascular surgeons evaluated each image in a masked manner. When there was discordance, a third evaluator was summoned. We evaluated the diagnostic accuracy of ICA stenosis of 50-94% and 70-94%. RESULTS: we included 45 patients and 84 arteries after inclusion and exclusion criteria applied. For the 50-94% stenosis range, DUS accuracy was 69%, sensitivity 89%, and specificity 63%. For the 70-94% stenosis range, DUS accuracy was 84%, sensitivity 61%, and specificity 93%. There was discordance between CTA evaluators with a change from clinical to surgical management in at least 37.5% of the conflicting reports. CONCLUSION: DUS had an accuracy of 69% for stenoses of 50-94% and 84% for stenoses of 70-94% of the ICA. The CTA analysis depended directly on the evaluator with a change in clinical conduct in more than 37% of cases.
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Artéria Carótida Interna , Estenose das Carótidas , Ultrassonografia Doppler Dupla , Humanos , Estenose das Carótidas/diagnóstico por imagem , Estudos Retrospectivos , Ultrassonografia Doppler Dupla/métodos , Masculino , Feminino , Artéria Carótida Interna/diagnóstico por imagem , Idoso , Pessoa de Meia-Idade , Sensibilidade e Especificidade , Angiografia por Tomografia Computadorizada/métodos , Idoso de 80 Anos ou maisRESUMO
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.
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Doença da Artéria Coronariana , Doença Arterial Periférica , Idoso , Feminino , Humanos , Masculino , Brasil/epidemiologia , Doença da Artéria Coronariana/tratamento farmacológico , Doença Arterial Periférica/epidemiologia , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Rivaroxabana/uso terapêutico , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Estudos Observacionais como AssuntoRESUMO
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.
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Doença Arterial Periférica , Abandono do Hábito de Fumar , Humanos , Doença Arterial Periférica/cirurgia , Revisões Sistemáticas como AssuntoRESUMO
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).
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Tromboembolia Venosa , Trombose Venosa , Humanos , Anticoagulantes/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombose Venosa/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológicoRESUMO
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.
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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 (CEAPâC), 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.
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Síndrome Pós-Trombótica , Trombose Venosa , Humanos , Síndrome Pós-Trombótica/diagnóstico , Síndrome Pós-Trombótica/epidemiologia , Síndrome Pós-Trombótica/etiologia , Reprodutibilidade dos Testes , Ultrassonografia Doppler Dupla , Veias , Trombose Venosa/complicações , Trombose Venosa/diagnóstico por imagemRESUMO
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).
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COVID-19 , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , COVID-19/complicações , Estudos de Coortes , Brasil/epidemiologia , Hospitalização , Unidades de Terapia Intensiva , Estado Terminal , Estudos RetrospectivosRESUMO
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.
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Procedimentos Cirúrgicos Cardíacos , Cardiopatias Congênitas , Extubação/métodos , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Criança , Cardiopatias Congênitas/cirurgia , Humanos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Congenital vascular anomalies and hemangiomas (CVAH) such as infantile hemangiomas, port-wine stains and brain arteriovenous malformations (AVMs) impair patients' lives and may require treatment if complications occur. However, a great variety of treatments for those conditions exist and the best interventions remain under discussion. OBJECTIVE: To summarize Cochrane systematic review (SR) evidence on treatments for CVAH. DESIGN AND SETTING: Review of SRs conducted in the Division of Vascular and Endovascular Surgery of Universidade Federal de São Paulo, Brazil. METHODS: A broad search was conducted on March 9, 2021, in the Cochrane Database of Systematic Reviews to retrieve any Cochrane SRs that assessed treatments for CVAH. The key characteristics and results of all SRs included were summarized and discussed. RESULTS: A total of three SRs fulfilled the inclusion criteria and were presented as a qualitative synthesis. One SR reported a significant clinical reduction of skin redness by at least 20%, with more pain, among 103 participants with port-wine stains. One SR reported that propranolol improved the likelihood of clearance 13 to 16-fold among 312 children with hemangiomas. One SR reported that the relative risk of death or dependence was 2.53 times greater in the intervention arm than with conservative management, among 218 participants with brain AVMs. CONCLUSION: Cochrane reviews suggest that treatment of port-wine stains with pulsed-dye laser improves redness; propranolol remains the best option for infantile hemangiomas; and conservative management seems to be superior to surgical intervention for treating brain AVMs.
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Malformações Arteriovenosas , Hemangioma , Mancha Vinho do Porto , Malformações Arteriovenosas/terapia , Brasil , Criança , Hemangioma/terapia , Humanos , Mancha Vinho do Porto/cirurgia , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Peripheral arterial disease (PAD) is characterized by progressive narrowing of the arterial lumen, resulting from atherosclerotic plaques. Treatment for PAD aims to control atherosclerosis and improve blood flow. Use of antiplatelet agents and anticoagulants has played important roles in helping to prevent occlusions and stenosis. OBJECTIVE: To evaluate the evidence from Cochrane systematic reviews regarding the accuracy, effectiveness and safety of use of anticoagulants and antiplatelets in lower-limb revascularization, in patients with peripheral arterial disease. METHODS: Systematic reviews found through searches in the Cochrane Library were included. Two authors evaluated whether the reviews found were in line with the inclusion criteria for this investigation. A qualitative synthesis of their findings was presented. RESULTS: Three systematic Cochrane reviews were included. Patients who underwent prosthetic bypass surgery probably presented greater benefit from use of antiplatelets, and patients who underwent vein revascularization probably presented greater benefit from use of anticoagulants. Patients who received endovascular treatment benefited from both antiplatelet and anticoagulant treatment. However, the reliability of the results found was impaired because at the time when these reviews were published, there was no mandatory assessment using the GRADE criteria. CONCLUSION: Despite the evidence found, it is necessary for these reviews to be updated in order to evaluate the degree of certainty of the results found.
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Doença Arterial Periférica , Preparações Farmacêuticas , Fibrinolíticos/uso terapêutico , Humanos , Doença Arterial Periférica/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Reprodutibilidade dos TestesRESUMO
OBJECTIVE: To investigate the efficacy of a short-term application of Transcutaneous Electric Nerve Stimulation to relieve rest pain in patients with chronic limb-threatening ischemia. METHODS: In patients ³18 years old, with chronic limb-threatening ischemia and rest pain ³3 in the Visual Analogue Scale, without diabetic neuropathy were randomly assigned to 1) Transcutaneous Electric Nerve Stimulation (100 Hz, 200 µs) or 2) sham intervention, both during one or two 20 min treatment sessions. The primary outcome was pain intensity, assessed by the visual analogue scale (0-10 cm) and described by the McGill Pain Questionnaire. We used a t-test for difference of means. RESULTS: A total of 169 patients were assessed, 23 met the study criteria and were randomized. Thirty-four applications were performed in two days: in the 17 Transcutaneous Nerve Stimulation and 17 sham. The within-group analysis indicated a pain decrease in both groups (Transcutaneous Electric Nerve Stimulation, from 7-3.9 cm, p<0.0001, and sham from 5.8-3.2 cm, p<0.0001). No statistically significant difference was verified between-groups (p=0.5). CONCLUSIONS: Both groups showed a decrease in rest pain of 54 and 55%, respectively. However, there was no difference between short-term high-frequency Transcutaneous Electric Nerve Stimulation and sham intervention to relieve ischemic rest pain in chronic limb-threatening ischemia patients.
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Estimulação Elétrica Nervosa Transcutânea , Humanos , Pacientes Internados , Isquemia/terapia , Dor , Medição da Dor , Resultado do TratamentoRESUMO
BACKGROUND: COVID-19 infection has high transmissibility and several measures have been adopted for controlling its dissemination. OBJECTIVE: To identify and summarize the evidence from Cochrane systematic reviews (SRs) regarding measures for controlling the dissemination of COVID-19 infection. DESIGN AND SETTING: This review of Cochrane SRs was carried out in the Division of Vascular and Endovascular Surgery and in the Division of Emergency Medicine and Evidence-Based Medicine of Universidade Federal de São Paulo, Brazil. METHODS: A comprehensive search in the Cochrane Database of Systematic Reviews retrieved all Cochrane SRs directly related to measures for controlling COVID-19 dissemination. The main characteristics and results of all the SRs included were summarized and discussed. RESULTS: Three Cochrane SRs were included in the qualitative synthesis. These evaluated population-based and individual measures for controlling the dissemination of COVID-19. CONCLUSION: Low-certainty evidence shows that quarantine for people exposed to confirmed or suspected COVID-19 cases prevented 44% to 81% of incident cases and 31% to 63% of deaths, compared with situations of no measures. Moreover, the sooner the quarantine measures were implemented, the greater the cost savings were. High-confidence evidence showed that clear communication about infection control and prevention guidelines was vital for successful implementation. Low-certainty evidence showed that healthcare professionals with long gowns were less exposed to contamination than were those using coveralls. In addition, coveralls were more difficult to doff. Further SRs on controlling the dissemination of COVID-19 infection are desirable.
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Infecções por Coronavirus/transmissão , Pneumonia Viral/transmissão , Betacoronavirus , COVID-19 , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Quarentena , SARS-CoV-2 , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Since the first description of the central venous catheter (CVC) in 1952, it has been used for the rapid administration of drugs, chemotherapy, as a route for nutritional support, blood components, monitoring patients, or combinations of these. When CVC is used in the traditional routes (eg, subclavian, jugular, and femoral veins), the complication rates range up to 15% and are mainly due to mechanical dysfunction, infection, and thrombosis. The peripherally inserted central catheter (PICC) is an alternative option for CVC access. However, the clinical evidence for PICC compared to CVC is still under discussion. In this setting, this systematic review (SR) aims to assess the effects of PICC compared to CVC for intravenous access. METHODS: We will perform a comprehensive search for randomised controlled trials (RCTs), which compare PICC and traditional CVC for intravenous access. The search strategy will consider free text terms and controlled vocabulary (eg, MeSH and Entree) related to "peripherally inserted central venous catheter," "central venous access," "central venous catheter," "catheterisation, peripheral," "vascular access devices," "infusions, intravenous," "administration, intravenous," and "injections, intravenous." Searches will be carried out in these databases: MEDLINE (via PubMed), EMBASE (via Elsevier), Cochrane CENTRAL (via Wiley), IBECS, and LILACS (both via Virtual Health Library). We will consider catheter-related deep venous thrombosis and overall successful insertion rates as primary outcomes and haematoma, venous thromboembolism, reintervention derived from catheter dysfunction, catheter-related infections, and quality of life as secondary outcomes. Where results are not appropriate for a meta-analysis using RevMan 5 software (eg, if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed. RESULTS: Our SR will be conducted according to the Cochrane Handbook of Systematic Reviews of Interventions and the findings will be reported in compliance with PRISMA. CONCLUSION: Our study will provide evidence for the effects of PICC versus CVC for venous access. ETHICS AND DISSEMINATION: This SR has obtained formal ethical approval and was prospectively registered in Open Science Framework. The findings of this SR will be disseminated through peer-reviewed publications or conference presentations. REGISTRATION:: osf.io/xvhzf. ETHICAL APPROVAL: 69003717.2.0000.5505.
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Cateterismo Venoso Central , Cateterismo Periférico , Cateteres Venosos Centrais , Humanos , Metanálise como Assunto , Revisões Sistemáticas como AssuntoRESUMO
INTRODUCTION: Intensive care units focus primarily on life support and treatment of critically ill patients, but there are many survivors with complications, such as generalized muscle disorders, functional disability and reduced quality of life after hospital discharge, resulting from prolonged stays in these units. The current evidence suggests that early mobilization-based rehabilitation (exercise initiated immediately after the patient's significant physiological changes have stabilized) in critically ill adults can alleviate these complications from immobility and critical illness. However, there are a lack of practice guidelines, conflicting perceptions about safety, and knowledge gaps about benefits in the critically ill paediatric population. Therefore, we aim to assess the effects of early mobilization for children in intensive therapy. METHODS AND ANALYSIS: Systematic searches will be carried out in Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Cochrane Central Register of Controlled Trials, Latin American and Caribbean Centre on Health Sciences Information, Cumulative Index to Nursing & Allied Health Literature and physiotherapy evidence database databases at a minimum without date or language restrictions for relevant individual parallel, cross-over and cluster randomized controlled trials. In addition, a search will also be carried out in the World Health Organization International Clinical Trials Registry Platform, and in the clinical trial registries of ClinicalTrials.gov, looking for any on-going randomised controlled trials that compare early mobilization with any other type of intervention. Two review authors will independently perform data extraction and quality assessments of data from included studies, and any disagreements will be resolved by discussion or by arbitration. The primary outcomes will be mortality and adverse events. Secondary outcomes will include duration of critical care (days), duration of mechanical ventilation support, muscle strength, pain and neuropsychomotor development. The Cochrane handbook will be used for guidance. If the results are not appropriate for a meta-analysis in RevMan 5 software (e.g., if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed. ETHICS AND DISSEMINATION: This protocol was prospectively registered at Open Science Framework and approved by the Ethics and Research Committee of the Federal University of Sao Paulo (8543210519). We intend to update the public registry used in this review, report any important protocol amendments and publish the results in a widely accessible journal. REGISTRATION:: osf.io/ebju9.
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Cuidados Críticos , Deambulação Precoce , Unidades de Terapia Intensiva Pediátrica , Criança , Humanos , Metanálise como Assunto , Revisões Sistemáticas como AssuntoAssuntos
COVID-19 , Fibrinolíticos , Guias de Prática Clínica como Assunto , Humanos , COVID-19/complicações , Fibrinolíticos/uso terapêutico , Fibrinolíticos/administração & dosagem , SARS-CoV-2 , Anticoagulantes/uso terapêutico , Anticoagulantes/administração & dosagem , Tratamento Farmacológico da COVID-19 , Trombose/prevenção & controle , Trombose/tratamento farmacológico , Trombose/sangueRESUMO
INTRODUCTION: Perforator veins (PVs) play an important role in the development of chronic venous insufficiency and ulceration. Procedures to eliminate incompetence and reflux in PV may include open surgery, subfascial endoscopic surgery, intravenous ablation techniques and sclerotherapy. With the aim of filling the evidence gap, this is a protocol for a systematic review that will assess the effects of any form of intervention for the treatment of pathologic PVs of the lower limbs in patients with chronic venous disease. METHODS AND ANALYSIS: Systematic searches will be carried out in MEDLINE, EMBASE, Cochrane CENTRAL, IBECS and LILACS databases at a minimum without date or language restrictions for relevant randomised controlled trials (RCTs) and quasi-RCTs (trials in which the method of allocation is not truly random). In addition, a search will also be carried out in the WHO International Clinical Trials Registry Platform, in the clinical trial registries of ClinicalTrials.gov and in the grey literature source OpenGrey.eu. The RCT and quasi-RCT comparison techniques isolated or in combination for treating PVs will be considered. Three review authors will independently perform data extraction and quality assessments of data from included studies, and any disagreements will be resolved by discussion. The primary outcomes will be wound healing and pain. Secondary outcomes will include oedema, adverse events, recurrence or recanalisation, quality of life and economic aspects. The Cochrane handbook will be used for guidance. If the results are not appropriate for a meta-analysis in RevManV.5 software (eg, if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed. ETHICS AND DISSEMINATION: Ethics committee approval is not necessary. We intend to update the public registry used in this review, report any important protocol amendments and publish the results in a widely accessible journal. PROSPERO REGISTRATION NUMBER: CRD42018092974.
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Extremidade Inferior , Doenças Vasculares , Veias , Humanos , Ablação por Cateter , Doença Crônica , Endoscopia , Extremidade Inferior/irrigação sanguínea , Procedimentos Cirúrgicos Minimamente Invasivos , Projetos de Pesquisa , Escleroterapia , Resultado do Tratamento , Doenças Vasculares/patologia , Doenças Vasculares/cirurgia , Doenças Vasculares/terapia , Veias/patologia , Veias/cirurgia , Metanálise como Assunto , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Ultrasonography is currently used in investigating many vascular diseases, especially for guiding vascular access. OBJECTIVE: The objective here was to summarize the evidence from Cochrane systematic reviews (SRs) on the effects of ultrasound-guided vascular access as an intervention approach. DESIGN AND SETTING: Review of SRs, conducted in the Division of Vascular and Endovascular Surgery of Universidade Federal de São Paulo. METHODS: A broad search was conducted in the Cochrane Database of Systematic Reviews to retrieve any Cochrane SRs that assessed the effects of ultrasound guidance as a therapeutic approach towards performing any vascular access. The key characteristics and results of all the reviews included were summarized and discussed. RESULTS: Three SRs on venous access at all ages and one review on arterial access in pediatric participants were included. There was low to moderate certainty of evidence that ultrasound increased the success rate from the first puncture and the overall success rate of the procedure; and reduced the total rate of perioperative and postoperative adverse events, number of punctures, time needed to achieve success and rate of failure to place catheters. CONCLUSION: Evidence of low to moderate quality showed that ultrasound-guided vascular access seems to reduce the total rate of perioperative and postoperative complications/adverse effects, number of punctures, time needed to achieve success and rate of failure to perform venous catheterization in adults and arterial punctures in children. There is a lack of information regarding ultrasound-guided arterial puncture in adults. Further studies are still imperative for reaching solid conclusions, especially regarding arterial ultrasound-guided access.
Assuntos
Ultrassonografia de Intervenção/métodos , Dispositivos de Acesso Vascular , Ensaios Clínicos como Assunto , Medicina Baseada em Evidências , Humanos , Revisões Sistemáticas como AssuntoRESUMO
ABSTRACT Introduction: Internal carotid artery (ICA) stenosis causes about 15% of ischemic strokes. Duplex ultrasonography (DUS) is the first line of investigation of ICA stenosis, but its accuracy varies in the literature and it is usual to complement the study with another more accurate exam when faced with significant stenosis. There is a lack of studies that compare DUS with angiotomography (CTA) in the present literature. Methods: we performed an accuracy study, which compared DUS to CTA of patients in a tertiary hospital with a maximum interval of three months between tests. Patients were selected retrospectively, and two independent and certified vascular surgeons evaluated each image in a masked manner. When there was discordance, a third evaluator was summoned. We evaluated the diagnostic accuracy of ICA stenosis of 50-94% and 70-94%. Results: we included 45 patients and 84 arteries after inclusion and exclusion criteria applied. For the 50-94% stenosis range, DUS accuracy was 69%, sensitivity 89%, and specificity 63%. For the 70-94% stenosis range, DUS accuracy was 84%, sensitivity 61%, and specificity 93%. There was discordance between CTA evaluators with a change from clinical to surgical management in at least 37.5% of the conflicting reports. Conclusion: DUS had an accuracy of 69% for stenoses of 50-94% and 84% for stenoses of 70-94% of the ICA. The CTA analysis depended directly on the evaluator with a change in clinical conduct in more than 37% of cases.
RESUMO Introdução: a estenose da artéria carótida interna (ACI) causa cerca de 15% dos acidentes vasculares cerebrais isquêmicos. A ultrassonografia duplex (USD) é a primeira linha de investigação da estenose de ACI, mas sua acurácia varia na literatura e é comum complementar o estudo com outro exame de maior acurácia diante de estenose significativa. Há uma escassez de estudos que comparem a USD com a angiotomografia computadorizada (ATC) na literatura atual. Métodos: realizamos um estudo de acurácia, que comparou a USD à ATC de pacientes de um hospital terciário com um intervalo máximo de três meses entre os exames. Os pacientes foram selecionados retrospectivamente e dois cirurgiões vasculares independentes e certificados avaliaram cada imagem de maneira mascarada. Quando houve discordância, um terceiro avaliador foi convocado. Avaliou-se a precisão diagnóstica da estenose da ACI de 50-94% e 70-94%. Resultados: foram incluídos 45 pacientes e 84 artérias após a aplicação dos critérios de inclusão e exclusão. Para a faixa de estenose de 50-94%, a acurácia da USD foi 69%, sensibilidade 89% e especificidade 63%. Para a faixa de estenose de 70-94%, a acurácia da USD foi 84%, sensibilidade 61% e especificidade 93%. Ocorreu discordância entre avaliadores da ATC com mudança de conduta clínica para cirúrgica em pelo menos 37,5% dos laudos conflitantes. Conclusão: a USD teve uma acurácia de 69% para estenoses de 50-94% e de 84% para estenoses de 70-94% da ACI. A análise das ATC dependeu diretamente do avaliador com mudança de conduta clínica em mais de 37% dos casos.
RESUMO
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.