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1.
BMJ Open ; 14(2): e083488, 2024 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-38367965

RESUMO

INTRODUCTION: Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. METHODS AND ANALYSIS: A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN18501431.


Assuntos
Embolia Pulmonar , Tromboembolia Venosa , Trombose Venosa , Humanos , Anticoagulantes/efeitos adversos , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Medicina Estatal , Trombose Venosa/prevenção & controle , Trombose Venosa/tratamento farmacológico , Embolia Pulmonar/prevenção & controle , Embolia Pulmonar/tratamento farmacológico , Reino Unido
2.
J Cardiovasc Surg (Torino) ; 65(1): 5-11, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38300165

RESUMO

Acute deep venous thrombosis (DVT) is a common health problem, affecting millions of patients in Europe and the United States annually. Europe and US national clinical practice guidelines are formulated by evaluation of the available scientific evidence, with expert opinion to create pragmatic guidance for the optimal patient management, representing the best available knowledge at the time of publication, and providing the best evidence-based recommendations for vascular patient care and venous pathologies. We here focus on the novel recommendations proposed by European and US guidelines for acute DVT, denoting main differences between the two panels. This review gives vascular surgeons the opportunity to identify the key points of the two largest Vascular Committees guidelines, in order to use them and offer their best individualized treatment approach to the specific patient's anatomy, lesion, and history.


Assuntos
Trombose Venosa , Humanos , Estados Unidos , Trombose Venosa/terapia , Trombose Venosa/tratamento farmacológico , Veias , Europa (Continente)
3.
Eur J Vasc Endovasc Surg ; 67(2): 341-350, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37797931

RESUMO

OBJECTIVE: The endovascular treatment of venous obstruction has expanded significantly in recent years. Best practices for optimal patient outcomes are not well established and the evidence base is poor. The purpose of this study was to obtain consensus on management criteria for patients with lower extremity venous outflow obstruction. METHODS: The study was conducted as a two round Delphi consensus. Statements addressed imaging, symptoms and other baseline measures, differential diagnosis, treatment algorithm, indications for stenting, inflow and outflow assessment, successful procedural outcomes, post-procedure therapies and stent surveillance, and clinical success factors. Statements were prepared by six expert physicians (round 1, 40 statements) and an expanded panel of 24 physicians (round 2, 80 statements) and sent to a pre-identified group of venous experts who met qualifying criteria. A 9 point Likert scale was used and consensus was defined as ≥ 70% of respondents rating a statement between 7 and 9 (agreement) or between 1 and 3 (disagreement). Round 1 results were used to guide rewording and splitting compound statements for greater clarity in round 2. RESULTS: In round 1, 75 of 110 (68%) experts responded, and 91 of 121 (75%) experts responded in round 2. Round 1 achieved consensus in 32/40 (80%) statements. Consensus was not reached in the treatment algorithm section. Round 2 achieved consensus in 50/80 (62.5%). Statements reaching consensus were imaging (2/3, 66%), symptoms and other baseline measures (12/24, 50%), differential diagnosis (2/8, 25%), treatment algorithm (10/17, 59%), indications for stenting (10/10, 100%), inflow and outflow assessment (2/2, 100%), procedural outcomes (2/2, 100%), post-procedure therapies and stent surveillance, (5/7, 71%), and clinical success factors (5/7, 71%). CONCLUSION: This study demonstrated that considerable consensus was achieved between venous experts on the optimal management of lower extremity venous outflow obstruction. There were multiple domains where consensus is lacking, highlighting important areas for further investigation and research.

4.
Br J Surg ; 110(12): 1785-1792, 2023 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-37748866

RESUMO

METHODS: This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes. RESULTS: Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported. CONCLUSION: Supervised exercise therapy is effective and NMES may provide further benefit in mild IC.This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823.


Patients with intermittent claudication experience pain in their legs during walking or exercise which ends with rest. This severely impairs physical activity and quality of life. Treatment for such patients typically involves best medical therapy, which includes exercise advice. This study aimed to determine whether a neuromuscular electrical stimulation device improved the walking distance of patients with intermittent claudication compared to local standard care available (which may include supervised exercise therapy) in a trial. Supervised exercise improved walking distances but there was no difference in those that received a device in this patient group.


Assuntos
Claudicação Intermitente , Qualidade de Vida , Humanos , Claudicação Intermitente/terapia , Caminhada , Terapia por Exercício , Resultado do Tratamento , Estimulação Elétrica
5.
BMJ Open ; 13(1): e069802, 2023 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-36653057

RESUMO

INTRODUCTION: Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor. METHODS AND ANALYSIS: A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18-59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN13908683.


Assuntos
Tromboembolia Venosa , Adulto , Humanos , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/etiologia , Meias de Compressão/efeitos adversos , Qualidade de Vida , Assistência ao Convalescente , Alta do Paciente , Hospitais , Anticoagulantes
6.
Ann Surg ; 277(2): e467-e474, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-35916649

RESUMO

OBJECTIVE: The aim of this study was to identify potential biomarkers predictive of healing or failure to heal in a population with venous leg ulceration. SUMMARY BACKGROUND DATA: Venous leg ulceration presents important physical, psychological, social and financial burdens. Compression therapy is the main treatment, but it can be painful and time-consuming, with significant recurrence rates. The identification of a reliable biochemical signature with the ability to identify nonhealing ulcers has important translational applications for disease prognostication, personalized health care and the development of novel therapies. METHODS: Twenty-eight patients were assessed at baseline and at 20 weeks. Untargeted metabolic profiling was performed on urine, serum, and ulcer fluid, using mass spectrometry and nuclear magnetic resonance spectroscopy. RESULTS: A differential metabolic phenotype was identified in healing (n = 15) compared to nonhealing (n = 13) venous leg ulcer patients. Analysis of the assigned metabolites found ceramide and carnitine metabolism to be relevant pathways. In this pilot study, only serum biofluids could differentiate between healing and nonhealing patients. The ratio of carnitine to ceramide was able to differentiate between healing phenotypes with 100% sensitivity, 79% specificity, and 91% accuracy. CONCLUSIONS: This study reports a metabolic signature predictive of healing in venous leg ulceration and presents potential translational applications for disease prognostication and development of targeted therapies.


Assuntos
Úlcera Varicosa , Humanos , Úlcera Varicosa/terapia , Úlcera , Projetos Piloto , Cicatrização
7.
Br J Surg ; 110(2): 200-208, 2023 Jan 10.
Artigo em Inglês | MEDLINE | ID: mdl-36477259

RESUMO

BACKGROUND: Established condition-specific patient-reported outcome measures for varicose veins are limited to the measurement of health status and function. A treatment satisfaction measure is needed to understand patient satisfaction with different treatment options. The aim of this study was to design a Venous Treatment Satisfaction Questionnaire (VenousTSQ) that would be ready for large-scale data collection and psychometric evaluation. METHODS: Relevant items were selected from the -TSQ Item Library and new items were designed where necessary. A draft VenousTSQ was prepared using the existing AneurysmTSQ as a template. Fifteen interviews were conducted from 4 days to 16 months after the procedure. The interviews were designed to elicit important sources of satisfaction or dissatisfaction before completion of draft questionnaires. The VenousTSQ drafts were modified between sets of interviews until no further changes were required. RESULTS: The final VenousTSQ consists of two questionnaires: VenousTSQ early (VenousTSQe) and VenousTSQ status (VenousTSQs). Items that need be asked only once are in the VenousTSQe, whereas those that can usefully be asked more than once are in the VenousTSQs. Of the 16 unique items forming the VenousTSQ, 12 were from the -TSQ Item Library. Only 1 of these 12 required significant modification. CONCLUSIONS: The VenousTSQ represents a condition-specific psychological outcome measure for varicose veins, enabling patient satisfaction or dissatisfaction with such treatments to be measured. Large-scale data collection is under way to establish optimal scoring, quantitative validity, and reliability of the VenousTSQ.


Assuntos
Satisfação do Paciente , Varizes , Humanos , Reprodutibilidade dos Testes , Varizes/cirurgia , Inquéritos e Questionários , Psicometria , Satisfação Pessoal
10.
Int Angiol ; 41(1): 82-89, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34825799

RESUMO

BACKGROUND: Adequate tissue perfusion is an important prognostic and diagnostic factor during the management of lower limb peripheral arterial disease. Convenient and real-time tissue perfusion monitoring remains an elusive challenge. METHODS: Tissue perfusion on the dorsal and plantar surfaces of both feet of 20 participants was measured during and after cuff-induced ischemia using a novel 4-channel, laser-based perfusion monitoring device based on diffuse speckle contrast analysis technology (Pedra sensors). Participants were free of significant peripheral arterial disease. Transcutaneous partial pressure of oxygen (TcPO2) measurements were recorded concurrently for comparison. RESULTS: Pedra sensors detected perfusion changes significantly more quickly than TcPO2 sensors. One minute after induced ischemia, the mean percent changes from baseline values (before ischemia) were -22.7±32.0% and -3.1±8.8% (P<0.001) for Pedra and TcPO2 sensors, respectively. One minute into induced ischemia, Pedra sensors had reached 50.5% of the 5-minute ischemia reading whereas TcPO2 sensors had reached only 18.6% of the 5-minute reading (P=0.046). Pedra sensors reported hyperemia immediately after cuff release with a mean percent change from baseline of 143.8±122.3%/173.4±121.8% on the dorsal/plantar surfaces while TcPO2 measurements were still recording negative changes at that time (-26.7±19.4%/-18.6±24.4% dorsal/plantar). Pedra sensors exhibited markedly lower interobserver and intraobserver variability than TcPO2 sensors. CONCLUSIONS: A device based on diffuse speckle contrast analysis reported tissue perfusion in real time. Cuff-induced ischemia and hyperemia following cuff release were rapidly and consistently detected on both the dorsal and plantar surfaces of the foot. Diffuse speckle contrast analysis may have value for real-time perfusion monitoring during angiography procedures.


Assuntos
Monitorização Transcutânea dos Gases Sanguíneos , Doença Arterial Periférica , Estudos de Viabilidade , Humanos , Isquemia/diagnóstico , Perfusão , Doença Arterial Periférica/diagnóstico por imagem
12.
BMJ Open ; 11(4): e041748, 2021 04 02.
Artigo em Inglês | MEDLINE | ID: mdl-33811051

RESUMO

INTRODUCTION: Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. METHODS AND ANALYSIS: This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. ETHICS AND DISSEMINATION: Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN21541209.


Assuntos
Perna (Membro) , Qualidade de Vida , Aloenxertos , Derme , Humanos , Estudos Multicêntricos como Assunto , Recidiva Local de Neoplasia , Ensaios Clínicos Controlados Aleatórios como Assunto
13.
BMJ Open ; 11(4): e044285, 2021 04 12.
Artigo em Inglês | MEDLINE | ID: mdl-33846151

RESUMO

INTRODUCTION: Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT. METHODS AND ANALYSIS: Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23-32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective. ETHICS AND DISSEMINATION: UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN registration number 73041168.


Assuntos
Síndrome Pós-Trombótica , Trombose Venosa , Adulto , Humanos , Incidência , Londres , Síndrome Pós-Trombótica/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Meias de Compressão , Trombose Venosa/prevenção & controle
15.
Health Technol Assess ; 24(69): 1-80, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33275096

RESUMO

BACKGROUND: Patients admitted to hospital for surgery are at an increased risk of venous thromboembolism. Pharmaco-thromboprophylaxis and mechanical prophylaxis (usually graduated compression stockings or intermittent pneumatic compression) have been shown to reduce the incidence of venous thromboembolism. The evidence base supporting the National Institute for Health and Care Excellence's recommendation for the use of graduated compression stockings for venous thromboembolism prevention in the UK has recently been challenged. It is unclear if the risks and costs associated with graduated compression stockings are justified for deep-vein thrombosis prevention in moderate- and high-risk elective surgical inpatients receiving low-dose low-molecular-weight heparin pharmaco-thromboprophylaxis. OBJECTIVES: The primary objective was to compare the venous thromboembolism rate in elective surgical inpatients at moderate or high risk of venous thromboembolism who were receiving either graduated compression stockings and low-dose low-molecular-weight heparin (standard care) or low-dose low-molecular-weight heparin alone (intervention). DESIGN: This was a pragmatic, multicentre, prospective, non-inferiority, randomised controlled trial. SETTING: This took place in secondary care NHS hospitals in the UK. PARTICIPANTS: Patients aged ≥ 18 years who were assessed to be at moderate or high risk of venous thromboembolism according to the NHS England venous thromboembolism risk assessment tool (or the trust equivalent based on this form) and who were not contraindicated to low-molecular-weight heparin or graduated compression stockings were deemed eligible to take part. INTERVENTIONS: Participants were randomised 1 : 1 to either low-molecular-weight heparin or low-molecular-weight heparin and graduated compression stockings. MAIN OUTCOME MEASURES: The primary outcome measure was venous thromboembolism up to 90 days after surgery. A combined end point of duplex ultrasound-proven new lower-limb deep-vein thrombosis (symptomatic or asymptomatic) plus imaging-confirmed symptomatic pulmonary embolism. Secondary outcomes included quality of life, compliance with graduated compression stockings and low-molecular-weight heparin during admission, and all-cause mortality. RESULTS: A total of 1905 participants were randomised and 1858 were included in the intention-to-treat analysis. A primary outcome event occurred in 16 out of 937 (1.7%) patients in the low-molecular-weight heparin-alone arm compared with 13 out of 921 (1.4%) patients in the low-molecular-weight heparin plus graduated compression stockings arm. The risk difference between low-molecular-weight heparin and low-molecular-weight heparin plus graduated compression stockings was 0.30% (95% confidence interval -0.65% to 1.26%). As the 95% confidence interval did not cross the non-inferiority margin of 3.5% (p < 0.001 for non-inferiority), the results indicate that non-inferiority of low-molecular-weight heparin alone was shown. LIMITATIONS: In total, 13% of patients did not receive a duplex ultrasound scan that could have detected further asymptomatic deep-vein thrombosis. However, missing scans were balanced between both trial arms. The subpopulation of those aged ≥ 65 years assessed as being at a moderate risk of venous thromboembolism was under-represented in the study; however, this reflects that this group is under-represented in the general population. CONCLUSIONS: For elective surgical patients at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings. These findings indicate that graduated compression stockings may be unnecessary for most elective surgical patients. FUTURE WORK: Further studies are required to evaluate whether or not adjuvant graduated compression stockings have a role in patients receiving extended thromboprophylaxis, beyond the period of hospital admission, following elective surgery or in patients undergoing emergency surgical procedures. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13911492. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 69. See the NIHR Journals Library website for further project information.


WHY DID WE CONDUCT THIS RESEARCH?: People undergoing operations are at risk of developing blood clots in their legs, which is known as a deep-vein thrombosis. Blood clots occur for several reasons, such as not being able to move around after an operation, changes in the blood or damage to the veins in which blood travels. To decrease the risk of getting deep-vein thrombosis, patients having operations are given tight elastic socks to wear called graduated compression stockings. They are also given blood thinning medicine to prevent clotting. There is little evidence that wearing elastic socks in hospital will reduce the risk of blood clots if blood thinners are also given. Many patients say that the socks can hurt or cause bruising and can be difficult to put on. The graduated compression as an adjunct to thromboprophylaxis in surgery (GAPS) trial investigated whether or not patients having an operation would benefit from wearing elastic socks as well as getting blood thinners, or if blood thinners on their own prevented blood clots. WHAT DID WE DO?: A total of 1905 patients who were having operations at seven hospitals in England agreed to take part. They were randomly assigned to different treatments by a computer program. Half of the patients were given elastic socks plus blood thinners, and the other half were given the blood thinners alone. WHAT DID WE FIND?: There was no significant difference in the number of people who had a blood clot in either study group. This could mean that blood thinners are as good at stopping blood clots as blood thinners and elastic socks for patients having operations. WHAT COULD BE CARRIED OUT NEXT?: The NHS spends around £63M per year across England on elastic stockings. This research indicates that patients might not get extra benefit from wearing them if they have taken blood thinners.


Assuntos
Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Pacientes Internados , Meias de Compressão , Tromboembolia Venosa/prevenção & controle , Idoso , Procedimentos Cirúrgicos Eletivos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Reino Unido
17.
JAMA Surg ; 155(12): 1113-1121, 2020 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-32965493

RESUMO

Importance: One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. Objective: To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Design, Setting, and Participants: Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Interventions: Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main Outcomes and Measures: The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. Results: The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Conclusions and Relevance: Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. Trial Registration: ClinicalTrials.gov identifier: ISRCTN02335796.


Assuntos
Procedimentos Endovasculares , Custos de Cuidados de Saúde , Úlcera Varicosa/cirurgia , Idoso , Idoso de 80 Anos ou mais , Análise Custo-Benefício , Procedimentos Endovasculares/economia , Feminino , Humanos , Terapia a Laser , Masculino , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Ablação por Radiofrequência , Recidiva , Fatores de Tempo , Úlcera Varicosa/economia , Úlcera Varicosa/terapia , Cicatrização
18.
BMJ ; 369: m1309, 2020 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-32404430

RESUMO

OBJECTIVES: To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery. DESIGN: Open, multicentre, randomised, controlled, non-inferiority trial. SETTING: Seven National Health Service tertiary hospitals in the United Kingdom. PARTICIPANTS: 1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate. INTERVENTION: Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS. OUTCOME MEASURES: The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality. RESULTS: Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior. CONCLUSIONS: For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery. TRIAL REGISTRATION: ISRCTN13911492.


Assuntos
Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Meias de Compressão , Tromboembolia Venosa/prevenção & controle , Adjuvantes Farmacêuticos , Adulto , Idoso , Terapia Combinada , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento , Tromboembolia Venosa/etiologia
19.
Int Angiol ; 39(1): 3-16, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31814378

RESUMO

The aim of this manuscript was to establish a consensus for the management of acute and chronic venous obstruction among specialists in the UK. Specialist physicians representing vascular surgery, interventional radiology and hematology were invited to 3 meetings to discuss management of acute and chronic iliofemoral obstruction. The meetings outlined controversial areas, included a topic-by-topic review; and on completion reached a consensus when greater than 80% agreement was reached on each topic. Physicians from 19 UK hospitals agreed on treatment protocols and highlighted areas that need development. Potential standard treatment algorithms were created. It was decided to establish a national registry of venous patients led by representatives from the treating multidisciplinary teams. Technical improvements have facilitated invasive treatment of patients with acute and chronic venous obstruction; however, the evidence guiding treatment is weak. Treatment should be conducted in centers with multi-disciplinary input; robust, coordinated data collection; and regular outcome analysis to ensure safe and effective treatment and a basis for future evolvement.


Assuntos
Veia Femoral , Veia Ilíaca , Equipe de Assistência ao Paciente/normas , Trombose Venosa/terapia , Doença Aguda , Cateterismo , Doença Crônica , Consenso , Gerenciamento Clínico , Humanos , Seleção de Pacientes , Radiografia Intervencionista , Terapia Trombolítica , Reino Unido
20.
EJVES Short Rep ; 45: 14-16, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31650048

RESUMO

INTRODUCTION: Aneurysms of the extracranial carotid artery are rare. They are often asymptomatic but can lead to disabling stroke. This report describes a case of bilateral internal carotid artery aneurysms in a patient with Marfan syndrome. REPORT: A 65 year old woman with Marfan syndrome presented with an asymptomatic swelling in the right anterior triangle of the neck. Imaging revealed bilateral extracranial fusiform internal carotid artery aneurysms. Staged open repair was performed. The right side was repaired by aneurysm excision and primary end to end anastomosis. The left side was repaired with a great saphenous vein interposition graft. The patient is free from aneurysm related complications at six years, although recurrent dilatation is present on surveillance. DISCUSSION: Internal carotid aneurysms can be managed successfully by open repair. In patients with connective tissue disorders surveillance is required to monitor for post-operative aneurysmal dilatation.

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