Meta-analyses of sulodexide and other drugs in prevention and treatment of post-thrombotic syndrome.

OBJECTIVE: Post-thrombotic syndrome (PTS) is a common chronic complication of deep vein thrombosis. Elastic compression (ECS) is the common pillar for PTS prevention and treatment, while the pharmacological approach for PTS includes direct oral anticoagulants (DOACs) and venoactive drugs (VADs) for prevention and treatment, respectively. Sulodexide can be used both in long-term prevention and in the treatment of PTS. To better understand the efficacy of the main drugs used in the prevention (sulodexide or DOACs) and treatment of PTS (sulodexide or VADs), pairwise meta-analyses of observational studies and RCTs were conducted. MATERIALS AND METHODS: A literature search in MEDLINE, Embase, and Cochrane Library for observational studies and RCTs was performed. Incidence of PTS, reduction in PTS signs or symptoms and proportion of patients with complete venous ulcers healing were the primary outcomes for prevention and treatment of PTS, respectively. Fixed and Random effect model meta-analyses were performed. Heterogeneity and publication bias were assessed. R® software was used for the analysis. RESULTS: 893 articles were identified during the search. 8 observational studies (6 for DOACs and 2 for sulodexide) and 2 RCTs for sulodexide, out of the 11 studies included in the qualitative synthesis, were included for the prevention and treatment of PTS, respectively. Meta-analyses of observational studies showed an overall incidence of PTS of 15% (95% CI, 11-19) for sulodexide, and a 50% reduction of PTS signs and/or symptoms for rivaroxaban compared to warfarin (OR, 0.50; 95% CI, 0.38-0.65). The overall estimate of the two sulodexide RCTs showed a significant improvement in complete ulcer healing, with an OR of 2.32 (95% CI, 1.49-3.63). CONCLUSIONS: In prevention of PTS, sulodexide and rivaroxaban showed a low incidence and reduced risk of PTS respectively, while in PTS treatment, sulodexide was significantly effective in the complete ulcers healing. These results confirm the need to move from the traditional single-pillar approach with elastic compression stockings to a more effective multi-pillar approach, tailoring the treatment to each individual patient.

Textile Electrodes: Influence of Electrode Construction and Pressure on Stimulation Performance in Neuromuscular Electrical Stimulation (NMES).

The major reason for preventable hospital death is venous thromboembolism (VTE). Non-pharmacological treatment options include electrical stimulation or compression therapy to improve blood flow in the extremities. Textile electrodes offer potential to replace bulky devices commonly used in this field, thereby improving the user compliance. In this work, the performance of dry and wet knitted electrodes in combination with pressure application to the electrode was evaluated in neuromuscular electrical stimulation (NMES). A motor point stimulation on the calf was performed on nine healthy subjects to induce a plantarflexion and the required stimulation intensity as well as the perceived pain were assessed. The performance of the different electrode constructions was compared and the influence of the pressure application was analysed. The results show that wet textile electrodes (0.9 % saline solution) perform significantly better than dry electrodes. However, opportunities were found for improving the performance of dry textile electrodes by using an uneven surface topography in combination with an intermediate to high pressure application to the electrode (> 20 mmHg), e.g. by using a compression stocking. Moreover, the smaller of the two tested electrode areas (16 cm2; 32 cm2) appears to be favourable in terms of stimulation comfort and efficiency.

Prevention of leg cramps by using compression stockings or magnesium supplements in the 50-84 age group: study protocol for a randomised controlled trial.

BACKGROUND: Leg cramps are painful sensations of tightening in the muscles of the legs that commonly appear during the night and are often associated with secondary insomnia. They are common especially in older age. There is no evidence that any method of prevention of nocturnal leg cramps is both safe and effective. There are no previous trials concerning cramp prevention by using compression stockings. The objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by the daily use of knee-length compression stockings or magnesium supplements. METHODS: The study will be set in Finland, and 50-84-year-old volunteers will be recruited through Google Ads, the Finnish health library website and Finnish primary health care centres. The participants must have a minimum of two episodes of leg cramps per week for the past 4 weeks to be included in the study. The participants (n = 225) will be allocated to three equal groups: the compression stocking arm, the magnesium supplement arm and the placebo arm. The participants will go through 4 weeks of follow-up without intervention and then another 4 weeks of follow-up with the assigned intervention. The material for the study will be collected through electronic questionnaires. DISCUSSION: This protocol describes a study that compares compression stockings, magnesium supplements and placebo for the prevention of leg cramps. The results of this study can significantly improve knowledge on the methods of preventing leg cramps. TRIAL REGISTRATION: ClinicalTrials.gov NCT04694417. Registered on Jan 4, 2021.

Meias elásticas de compressão para o tratamento do linfedema de membros inferiores / Compressive elastic bands for the treatment of lower limb lymphedema

INTRODUÇÃO: O linfedema é uma doença crônica progressiva, ocasionada por insuficiência do processo de drenagem linfática, que causa edema tecidual. Não há nenhum tratamento curativo para o linfedema e no âmbito do Sistema Único de Saúde (SUS), estão listados dois procedimentos de manejo do linfedema: o atendimento fisioterapêutico e o tratamento cirúrgico do linfedema. As meias elásticas de compressão seriam uma opção de tratamento autogerido, o que pode reduzir a sobrecarga do sistema por procedimentos eletivos. PERGUNTA: O uso de meias elásticas de compressão é eficaz, efetivo, seguro e custo-efetivo para o tratamento de pacientes com linfedema primário ou secundário? EVIDÊNCIAS CIENTÍFICAS: A busca recuperou duas coortes prospectivas. O estudo de Brambilla et al., 2006 demonstrou diferença estatisticamente significante na redução do volume dos membros inferiores (mensurada por uso de fita métrica em vários pontos dos membros inferiores) entre os pacientes que utilizaram as meias elásticas de compressão em relação aos pacientes do grupo controle (que não usaram as meias). Contudo, as circunferências dos membros inferiores foram reduzidas de maneira irregular, 40% dos pacientes tratados com as meias elásticas de compressão apresentaram aumento do volume do membro e apenas 16,67% das reduções foram consideradas satisfatórias. Já o estudo de Godoy et al., 2017, uma coorte do tipo antes e depois, demonstrou diferença estatisticamente significante entre as meias de compressão de 30/40 mmHg e as de 20/30 mmHg, sendo esta última não efetiva na manutenção do volume dos membros após quatro semanas em relação a linha de base. Porém, nessa última coorte, as meias elásticas de compressão foram utilizadas para manutenção do volume dos membros após redução completa do edema por outros procedimentos terapêuticos. Não foram encontrados estudos referentes à adesão das meias elásticas de compressão na população com linfedema. Nenhum dos estudos incluídos relatou dados de segurança. As duas coortes apresentaram baixa qualidade metodológica, uma vez que receberam 5 estrelas ou menos nas ferramentas de Newcastle-Ottawa. A certeza da evidência de todos os desfechos, avaliada pelo Grading of Recommendations Assessment, Development and Evaluation, foi muito baixa. ANÁLISE DE IMPACTO ORÇAMENTÁRIO: Para um horizonte temporal de 5 anos, a incorporação das meias elásticas de compressão para linfedema ocasionaria um aumento de gastos estimados, em cinco anos, de R$117.900.922,59 a R$136.039.526,07, a depender da prevalência. CONSIDERAÇÕES FINAIS: As evidências disponíveis acerca da efetividade das meias elásticas de compressão em indivíduos com linfedema de membros inferiores são escassas e, de forma geral, de qualidade baixa. A avaliação econômica estimou uma RCEI R$ 2.155,87, ao passo que análise de impacto orçamentário estima um custo acumulado em cinco anos de até R$ 136 milhões no cenário de incorporação das meias elásticas de compressão. Não foram identificadas recomendações sobre o uso de meias elásticas no tratamento do linfedema em agências internacionais de ATS. Dessa forma, recomendações sobre o uso da tecnologia são permeadas de incertezas e devem ser realizadas com cautela. RECOMENDAÇÃO PRELIMINAR DA CONITEC: A Conitec, em sua 92ª reunião ordinária, realizada nos dias 04 de novembro de 2020, deliberou que a matéria fosse disponibilizada em consulta pública com recomendação preliminar não favorável à incorporação no SUS das meias elásticas de compressão como parte do tratamento de pacientes com linfedema de membros inferiores. Considerou-se, entre outros fatores, que, há escassez de evidências sobre o uso das meias elásticas de compressão no tratamento do linfedema de membros inferiores. Além disso, as poucas evidências disponíveis foram consideradas frágeis, com baixo número amostral e baixa qualidade, sendo, portanto, insuficientes para determinar com robustez a efetividade, a segurança, a custo-efetividade e o impacto orçamentário decorrente da incorporação das meias de compressão. CONSULTA PÚBLICA: O relatório de recomendação inicial da CONITEC foi disponibilizado para contribuições por meio da consulta pública nº 64/2020 entre os dias 25/11/2020 e 14/12/2020. Foram recebidas 163 contribuições, sendo 93 contribuições de cunho técnico-científico e 70 contribuições de experiência pessoal ou opinião, destas 84,7% discordavam com a recomendação preliminar da Conitec. RECOMENDAÇÃO FINAL: Os membros da Conitec presentes na 94ª reunião ordinária, no dia 03 de janeiro de 2021, deliberaram por unanimidade recomendar a não incorporação das meias elásticas de compressão para o tratamento de pacientes com linfedema. Os membros presentes entenderam que não houve argumentação suficiente para alterar a recomendação inicial. Foi assinado o registro de deliberação nº 585. DECISÃO: Não incorporar as meias elásticas de compressão como parte do tratamento de pacientes com linfedema de membros inferiores, do Sistema Único de Saúde - SUS, conforme Portaria nº 03, publicada no Diário Oficial da União nº 34, seção 1, página 93, em 22 de fevereiro de 2021.

Meias elásticas de compressão para o tratamento do linfedema de membros inferiores / Compressive elastic bands for the treatment of lower limb lymphedema

INTRODUÇÃO: O linfedema é uma doença crônica progressiva, ocasionada por insuficiência do processo de drenagem linfática, que causa edema tecidual. Não há nenhum tratamento curativo para o linfedema e no âmbito do Sistema Único de Saúde (SUS), estão listados dois procedimentos de manejo do linfedema: o atendimento fisioterapêutico e o tratamento cirúrgico do linfedema. As meias elásticas de compressão seriam uma opção de tratamento autogerido, o que pode reduzir a sobrecarga do sistema por procedimentos eletivos. PERGUNTA: O uso de meias elásticas de compressão é eficaz, efetivo, seguro e custo-efetivo para o tratamento de pacientes com linfedema primário ou secundário? EVIDÊNCIAS CIENTÍFICAS: A busca recuperou duas coortes prospectivas. O estudo de Brambilla et al., 2006 demonstrou diferença estatisticamente significante na redução do volume dos membros inferiores (mensurada por uso de fita métrica em vários pontos dos membros inferiores) entre os pacientes que utilizaram as meias elásticas de compressão em relação aos pacientes do grupo controle (que não usaram as meias). Contudo, as circunferências dos membros inferiores foram reduzidas de maneira irregular, 40% dos pacientes tratados com as meias elásticas de compressão apresentaram aumento do volume do membro e apenas 16,67% das reduções foram consideradas satisfatórias. Já o estudo de Godoy et al., 2017, uma coorte do tipo antes e depois, demonstrou diferença estatisticamente significante entre as meias de compressão de 30/40 mmHg e as de 20/30 mmHg, sendo esta última não efetiva na manutenção do volume dos membros após quatro semanas em relação a linha de base. Porém, nessa última coorte, as meias elásticas de compressão foram utilizadas para manutenção do volume dos membros após redução completa do edema por outros procedimentos terapêuticos. Não foram encontrados estudos referentes à adesão das meias elásticas de compressão na população com linfedema. Nenhum dos estudos incluídos relatou dados de segurança. As duas coortes apresentaram baixa qualidade metodológica, uma vez que receberam 5 estrelas ou menos nas ferramentas de Newcastle-Ottawa. A certeza da evidência de todos os desfechos, avaliada pelo Grading of Recommendations Assessment, Development and Evaluation, foi muito baixa. AVALIAÇÃO ECONÔMICA: Foi conduzida uma avaliação econômica do tipo árvore de decisão, comparando as meias elásticas de compressão com o cuidado convencional, na perspectiva do SUS, em um horizonte temporal de 12 meses. A partir da estratégia escolhida, os indivíduos com linfedema seguem o curso de eventos sequenciais de sucesso terapêutico (redução clinicamente relevante do edema) e de falha terapêutica (redução não satisfatória do edema ou aumento do edema). O desfecho de efetividade foi retirado do estudo Brambilla et al., 2006. A estimativa dos números de sessões de fisioterapia e tratamento cirúrgico do linfedema foram feitas baseadas nos dados de uso dos procedimentos no Departamento de Informática do SUS. Assim, a razão de custo-efetividade incremental (RCEI) foi de R$ 2.155,87 para que um paciente alcance uma redução do volume dos membros inferiores com o uso da intervenção das meias elásticas de compressão, comparado ao cuidado convencional. A análise de sensibilidade mostrou que, independentemente do custo de aquisição das meias elásticas e da frequência de realização dos procedimentos, a intervenção continua sendo dominada pelo cuidado convencional. ANÁLISE DE IMPACTO ORÇAMENTÁRIO: Para um horizonte temporal de 5 anos, a incorporação das meias elásticas de compressão para linfedema ocasionaria um aumento de gastos estimados, em cinco anos, de R$117.900.922,59 a R$136.039.526,07, a depender da prevalência. RECOMENDAÇÕES INTERNACIONAIS: O National Institute for Care Execellence e Canadian Agency for Drugs and Technologies in Health ainda não avaliaram o uso das meias compressivas no tratamento do linfedema de membros inferiores. Não foram encontrados relatos de incorporação das meias de compressão nas agências Scottish Medicines Consortium e Pharmaceutical Benefits Advisory Committee. CONSIDERAÇÕES FINAIS: As evidências disponíveis acerca da efetividade das meias elásticas de compressão em indivíduos com linfedema de membros inferiores são escassas e, de forma geral, de qualidade baixa. A avaliação econômica estimou uma RCEI R$ 2.155,87, ao passo que análise de impacto orçamentário estima um custo acumulado em cinco anos de até R$ 136 milhões no cenário de incorporação das meias elásticas de compressão. Não foram identificadas recomendações sobre o uso de meias elásticas no tratamento do linfedema em agências internacionais de ATS. Dessa forma, recomendações sobre o uso da tecnologia são permeadas de incertezas e devem ser realizadas com cautela. RECOMENDAÇÃO PRELIMINAR DA CONITEC: A Conitec, em sua 92ª reunião ordinária, realizada nos dias 04 de novembro de 2020, deliberou que a matéria fosse disponibilizada em consulta pública com recomendação preliminar não favorável à incorporação no SUS das meias elásticas de compressão como parte do tratamento de pacientes com linfedema de membros inferiores. Considerou-se, entre outros fatores, que, há escassez de evidências sobre o uso das meias elásticas de compressão no tratamento do linfedema de membros inferiores. Além disso, as poucas evidências disponíveis foram consideradas frágeis, com baixo número amostral e baixa qualidade, sendo, portanto, insuficientes para determinar com robustez a efetividade, a segurança, a custo-efetividade e o impacto orçamentário decorrente da incorporação das meias de compressão. CONSULTA PÚBLICA: O relatório de recomendação inicial da CONITEC foi disponibilizado para contribuições por meio da consulta pública nº 64/2020 entre os dias 25/11/2020 e 14/12/2020. Foram recebidas 163 contribuições, sendo 93 contribuições de cunho técnico-científico e 70 contribuições de experiência pessoal ou opinião, destas 84,7% discordavam com a recomendação preliminar da Conitec. RECOMENDAÇÃO FINAL: Os membros da Conitec presentes na 94ª reunião ordinária, no dia 03 de janeiro de 2021, deliberaram por unanimidade recomendar a não incorporação das meias elásticas de compressão para o tratamento de pacientes com linfedema. Os membros presentes entenderam que não houve argumentação suficiente para alterar a recomendação inicial. Foi assinado o registro de deliberação nº 585. DECISÃO: Não incorporar as meias elásticas de compressão como parte do tratamento de pacientes com linfedema de membros inferiores, do Sistema Único de Saúde - SUS, conforme Portaria nº 03, publicada no Diário Oficial da União nº 34, seção 1, página 93, em 22 de fevereiro de 2021.

[Conservative treatment of varicose veins]. / Konservative Therapie der Varikose.

The treatment of varicose veins is supposed to eliminate congestive symptoms and edema, heal skin complications and prevent complications. Surgical procedures, endovenous thermal procedures, endovenous chemical procedures and conservative measures are used for treatment. Often the invasive and conservative procedures are combined. A precise examination of the varicose veins is required for therapy planning; duplex sonography is the gold standard. Conservative therapy focuses on compression therapy with compression bandages and with compression stockings. Medical adaptive compression systems are also used in the decongestion phase. Extract from red vine leafs, extract from horse chestnut seed and oxerutin are available for oral drug therapy. Conservative therapy is especially indicated when treatment of symptomatic varicose veins is not possible or when symptomatic venous disease persists even after invasive therapy.

Interventions for preventing venous thromboembolism in adults undergoing knee arthroscopy.

BACKGROUND: Knee arthroscopy (KA) is a routine orthopedic procedure recommended to repair cruciate ligaments and meniscus injuries and in eligible patients, to assist the diagnosis of persistent knee pain. KA is associated with a small risk of thromboembolic events. This systematic review aims to assess if pharmacological or non-pharmacological interventions may reduce this risk. This review is the second update of the review first published in 2007. OBJECTIVES: To assess the efficacy and safety of interventions, whether mechanical, pharmacological, or in combination, for thromboprophylaxis in adult patients undergoing KA. SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, the CENTRAL, MEDLINE, Embase and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 14 August 2019. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and controlled clinical trials (CCTs), whether blinded or not, of all types of interventions used to prevent deep vein thrombosis (DVT) in males and females aged 18 years and older undergoing KA. There were no restrictions on language or publication status. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, assessed trial quality with the Cochrane 'Risk of bias' tool, and extracted data. A third author addressed discrepancies. We contacted study authors for additional information when required. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: This update adds four new studies, bringing the total of included studies to eight and involving 3818 adult participants with no history of thromboembolic disease undergoing KA. Studies compared daily subcutaneous (sc) low-molecular-weight heparin (LMWH) versus control (five studies); oral rivaroxaban 10 mg versus placebo (one study); daily sc LMWH versus graduated compression stockings (GCS) (one study); and aspirin versus control (one study). The incidence of pulmonary embolism (PE) in all trials combined was low, with seven cases in 3818 participants.There were no deaths in any of the intervention or control groups. LMWH versus control When compared with control, LMWH probably results in little to no difference in the incidence of PE in patients undergoing KA (risk ratio (RR) 1.81, 95% confidence interval (CI) 0.49 to 6.65; 1820 participants; 3 studies; moderate-certainty evidence). LMWH showed no reduction of the incidence of symptomatic DVT (RR 0.61, 95% CI 0.18 to 2.03; 1848 participants; 4 studies; moderate-certainty evidence). LMWH may reduce the risk of asymptomatic DVT but the evidence is very uncertain (RR 0.14, 95% CI 0.03 to 0.61; 369 participants; 2 studies; very low-certainty evidence). There was no evidence of an increased risk of all adverse events combined (RR 1.85, 95% CI 0.95 to 3.59; 1978 participants; 5 studies; moderate-certainty evidence). No evidence of a clear effect on major bleeding (RR 0.98, 95% CI 0.06 to 15.72; 1451 participants; 1 study; moderate-certainty evidence), or minor bleeding was observed (RR 1.79, 95% CI 0.84 to 3.84; 1978 participants; 5 studies; moderate-certainty evidence). Rivaroxaban versus placebo One study with 234 participants compared oral rivaroxaban 10 mg versus placebo. No evidence of a clear impact on the risk of PE (no events in either group), symptomatic DVT (RR 0.16, 95% CI 0.02 to 1.29; moderate-certainty evidence); or asymptomatic DVT (RR 0.95, 95% CI 0.06 to 15.01; very low-certainty evidence) was detected. Only bleeding adverse events were reported. No major bleeds occurred in either group and there was no evidence of differences in minor bleeding between the groups (RR 0.63, 95% CI 0.18 to 2.19; moderate-certainty evidence). Aspirin versus control One study compared aspirin with control. No PE, DVT or asymptomatic events were detected in either group. Adverse events including pain and swelling were reported but it was not clear what groups these were in. No bleeds were reported. LMWH versus GCS One study with 1317 participants compared the use of LMWH versus GCS. There was no clear difference in the risk of PE (RR 1.00, 95% CI 0.14 to 7.05; low-certainty evidence). LMWH use did reduce the risk of DVT compared to people using GCS (RR 0.17, 95% CI 0.04 to 0.75; low-certainty evidence). No clear difference in effects was seen between the groups for asymptomatic DVT (RR 0.47, 95% CI 0.21 to 1.09; very low-certainty evidence); major bleeding (RR 3.01, 95% CI 0.61 to 14.88; moderate-certainty evidence) or minor bleeding (RR 1.16, 95% CI 0.64 to 2.08; moderate-certainty evidence). Levels of thromboembolic events were higher in the GCS group than in any other group. We downgraded the certainty of the evidence for imprecision resulting from overall small event numbers; risk of bias due to concerns about lack of blinding, and indirectness as we were uncertain about the direct clinical relevance of asymptomatic DVT detection. AUTHORS' CONCLUSIONS: There is a small risk that healthy adult patients undergoing KA will develop venous thromboembolism (PE or DVT). There is moderate- to low-certainty evidence of no benefit from the use of LMWH, aspirin or rivaroxaban in reducing this small risk of PE or symptomatic DVT. There is very low-certainty evidence that LMWH use may reduce the risk of asymptomatic DVT when compared to no treatment but it is uncertain how this directly relates to incidence of DVT or PE in healthy patients. No evidence of differences in adverse events (including major and minor bleeding) was seen, but data relating to this were limited due to low numbers of events in the studies reporting within the comparisons.

Unna boot therapy impact on wellbeing, hope and spirituality in venous leg ulcer patients: a prospective clinical trial.

OBJECTIVE: To assess the impact of Unna boot therapy on subjective wellbeing, hope and spirituality in patients with venous leg ulcers (VLU). METHOD: This was a prospective, descriptive, analytical, multicentre clinical trial conducted in a nursing care and education centre, an outpatient wound care clinic and a primary health care unit in Brazil. Adult patients with VLUs took part in the study. Patients with diabetic foot ulcers and mixed ulcers were excluded. A questionnaire assessing sociodemographic and religious characteristics of patients, the Subjective Wellbeing Scale, the Spirituality Self-Rating Scale (SSRS), and the Herth Hope Index (HHI) were administered to all patients. RESULTS: A total of 60 patients (63.3% female; 86.7% aged ≥60 years) participated. Before Unna boot therapy, 65%, 66.7% and 65% of patients reported a score of one on positive affect, negative affect and life satisfaction, respectively, indicating poor subjective wellbeing. After one month of compression therapy, 66.7%, 50.0%, and 80.0% of patients reported a score of three for each element positive affect, negative affect and life satisfaction, respectively, showing a significant improvement in subjective wellbeing (p=0.029). A significant increase in total SSRS scores (p=0.017) was found between baseline (mean: 9.77) and one month of treatment (mean: 25.47), indicating a significant increase in a sense of spirituality. There was also a significant increase in total HHI values (p=0.009) between baseline (mean: 15.68) and one month of compression therapy (mean: 39.38), suggesting a significant increase in hope among patients. CONCLUSION: Patients with VLUs treated with Unna boot therapy in this study showed significant improvement in subjective wellbeing, spirituality and hope for cure.

A Single-Centre Feasibility Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between a Neuromuscular Electrostimulation Device and Thromboembolism Deterrent Stockings in Post-Operative Patients Recovering From Elective Total Hip Replacement Surgery.

BACKGROUND: Total hip replacement is recognised as a major risk factor for deep vein thrombosis (DVT). The aim of this study was to investigate the feasibility of using a novel neuromuscular electrical stimulation device (NMES) for DVT prevention in patients recovering from elective hip replacement surgery. METHODS: Twenty-eight patients undergoing total hip replacement were randomised to receive postoperative treatment with either the NMES device or compression stockings continually from post-surgery until discharge (day 4). The primary outcome measure was the presence of symptomatic or asymptomatic DVT at 48 hours post-surgery and on the day of discharge from hip replacement surgery, as assessed by Duplex ultrasound. Secondary outcomes included hemodynamic responses to the devices, lower limb oedema, sit-to-stand and timed-up-and-go (TUG) scores, and hip range of motion. RESULTS: In the compression stockings group, two cases of asymptomatic DVT were identified by Duplex ultrasound at 48 hours post-surgery. No cases were found in the NMES group. Patients in the NMES group demonstrated a general trend of a decrease in leg volume from post-surgery to discharge, whereas leg volume largely remained static for the compression stockings group. In addition, positive hemodynamic effects were found in favour of the NMES group in the non-operated leg. The change in TUG scores also favoured the NMES group (NMES: 150 ± 152%, compression stockings: 363 ± 257% (p=0.03)), whereas no differences in sit-to-stand scores or hip range of motion were observed. CONCLUSIONS: This study supports the feasibility of NMES as an alternative mechanical prophylaxis worn in the postoperative phase until discharge and provides important findings for clinicians considering novel mechanical prophylaxis options.

Treatment of chronic venous insufficiency in Latin America.

OBJECTIVE: Venous disease is common in Latin America, with an estimated 68.11% prevalence of chronic venous disease. The diverse social, political, and economic characteristics of the many nations that make up Latin America mean that different conditions affect how these diseases are diagnosed and treated, which may differ markedly from the way they are treated by the health care systems of the United States and Europe. Our goal was to review the current state of treatment of chronic venous insufficiency (CVI) in Latin America. METHODS: This is a narrative review of the medical literature on the subject and synthesizes sometimes fragmentary information on CVI across a large and diverse region. RESULTS: CVI represents an unmet medical need in Latin America. Conservative treatments, such as compression stockings, may be used at first, and there are nonpharmacologic and complementary and alternative medicine approaches in use. Endovenous approaches, such as endovenous thermal ablation, have largely replaced surgical interventions. In Europe and the United States, such procedures are mainly carried out in ambulatory facilities, whereas they are mainly performed in the hospital in Latin America. CONCLUSIONS: Recent strong economic growth in Latin America and improvements in social security and health care suggest that innovative approaches to chronic venous disease and CVI will be implemented.

A compression device versus compression stockings in long-term therapy of lower limb primary lymphoedema after liposuction.

OBJECTIVE: Primary lymphoedema is rare and in most cases develops in the lower extremities. In some cases, conservative treatment is insufficient and can be supported by surgical procedure. The aim of this case study was to show the difference in the effectiveness of a compression wrap device and compression stockings in the treatment of primary lymphoedema. METHOD: Before and after liposuction the patient was treated on an outpatient basis every day for three weeks. This consisted of complex decongestive therapy (CDT) including manual lymph drainage, tailored exercises, skin and nail care, compression therapy and intermittent pneumatic compression. After CDT, the patient was provided with a flat-knit compression garment. Measurements were taken at one week and at three months of wearing the compression garment. The oedema severity was measured by summary calculation method. For both healthy and swollen limbs, the sum of circumferences taken at nine fixed measuring points was determined. The difference between these sums expressed in percents was presented as a relative metric coefficient of leg lymphoedema (RMCL). RESULTS: At the start of therapy, the difference in circumference between the healthy and swollen limb was 21.85%. After CDT (RMCL: 13.46%), the patient was provided with a flat-knit compression stocking (class 3). After one week, the RMCL was 15.92%, while after three months RCML was 20.84%. Because fluid retention was observed the patient was again treated with CDT (RMCL: 13.89%). The patient was provided with compression stocking (class 4). After one week of wearing, the RMCL was 15.77%, while after three months RMCL was 20.26%. As the results proved unsatisfactory, the patient was treated with CDT (RMCL: 13.60%) and a combination of two class 4 compression stockings was used. After one week, RMCL was 14.91%, while after three months RMCL was 19.25%. As the effects of oedema reduction were insufficient, the patient was treated again with CDT (RMCL: 13.89%) and advised to replace one of the stockings with a CirAid device (adjustable compression wrap). After one week, RMCL was 14.18% and after three months RMCL was 14.76%. The patient then qualified for liposuction (RMCL: 7.81%). At three months after surgery, the compression stocking was replaced by an adjustable compression wrap, to reduce the difference in circumference between healthy and swollen limbs (from 21.85 % to 8.68%). CONCLUSION: This case study shows that in primary oedema one class of compression garment is not always sufficient, nor is the combination of two garments with varying degrees of compression. In some cases, the situation requires the use of non-elastic leg binders such as a CircAid device which, thanks to its greater stiffness, helps improve clinical outcomes.

Efficacy and Safety of 4% Hibiscus rosa-sinensis Leaf Extract Ointment as an Adjunct Treatment to Compression Stockings on the Closure of Venous Leg Ulcers: A Pilot Study.

INTRODUCTION: Venous leg ulcers (VLUs), the most common leg ulceration worldwide, are caused by venous hypertension due to venous reflux, the failure of the calf muscle to pump, and venous flow obstruction. They are associated with a reduced quality of life, particularly in relation to pain and physical function. Hibiscus rosa-sinensis is commonly employed because of its many medicinal properties, and studies have shown Hibiscus contains phytochemicals that have antimicrobial, antioxidant, and anti-inflammatory properties that promote wound healing. OBJECTIVE: The authors evaluate the efficacy and safety of 4% gumamela leaf extract ointment in the closure of VLUs among patients seen in a dermatology outpatient department in the Philippines. MATERIALS AND METHODS: The study included male or female patients with leg ulcers confirmed by duplex scan to be venous in origin and willing to have elastic compression therapy. Patients were instructed to clean the wound with normal saline solution and to apply the extract twice daily. The study was conducted for 12 weeks or until wound closure. Wounds were evaluated and photographed at baseline and every subsequent 2 weeks. Efficacy of therapy was evaluated based on ulcer area size using planimetry method at each visit. Safety was assessed using a 4-point grading system to monitor possible adverse reactions, namely pruritus, rash, burning, and urticaria. RESULTS: Twelve patients were included in the study; 5 patients had an initial ulcer area of ⟩ 10 cm2 and 7 had an initial ulcer area of ≤ 10 cm2. By the end of the study, 10 patients (83.3%) achieved complete ulcer closure in ⟨ 12 weeks, 1 patient (8.3%) had a decrease in ulcer area ⟩ 50% by week 12, and 1 patient (8.3%) had ⟨ 50% decrease in ulcer area at the end of the study. CONCLUSIONS: Data showed compression stockings with 4% gumamela leaf extract ointment application could close VLUs in ⟨ 12 weeks. Applied with compression stockings, the ointment shows potential use in VLU management.

Use of a Muscle Pump Activator Leads to Improved Lower Limb Edema, Lower Limb Blood Flow, and Urine Output Compared With Standard TED Stockings and Compression Devices Following Kidney Transplant: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to evaluate the effects of using thromboembolic deterrent (TED) stockings and intermittent pneumatic compression (IPC) vs a muscle pump activator (MPA) device on limb edema and patient satisfaction after transplant. METHODS: In this single-center randomized controlled trial, 118 patients were randomly assigned to wear TED + IPC (n = 64) or the MPA device (n = 54) from postoperative days 1 to 6. We measured patients' weight and lower leg and thigh circumferences daily. Ultrasonography of the allograft and lower limbs was carried out on postoperative days 1 and 5 to assess resistive index in the transplanted kidney and flow in the femoral vein. We monitored urine output and serum creatinine level. RESULTS: We observed a significant increase in calf and thigh circumference from baseline in the TED + IPC group but not in the MPA group (2.3 [SD, 1] cm vs 0.25 [SD, 0.8] cm, respectively, P < .002). Ultrasonography showed higher femoral vein velocities in the MPA group than the TED + IPC group (0.5 [SD, 0.2] cm, P < .001). The mean total urine output in 6 days was higher in the MPA group than the TED + IPC group (P = .05), which corresponded to large change in TED + IPC weight of 6.2 kg vs 2.1 kg in the MPA group (P = .04). Patients were more satisfied with the use of the MPA device than TED + IPC. No major complications were encountered in either group. CONCLUSIONS: This is the first study to show that the use of an MPA device in the immediate postoperative period following kidney transplant leads to decreased lower limb edema and increased total urine output. Patients were more satisfied with the use of the MPA device than TED + IPC.

Chronic venous insufficiency and venous microangiopathy: management with compression and Pycnogenol®.

BACKGROUND: The aim of this prospective supplement summer registry study was to evaluate the efficacy of Pycnogenol® in controlling symptoms of chronic venous insufficiency (CVI) and microcirculatory parameters: venous hypertension and microangiopathy. Pycnogenol® (Horphag Research) is the standardized extract of the bark of Pinus Pinaster. METHODS: During the summer period between June and August 142 patients were split into three groups: 1) Pycnogenol® 150 mg/day; 2) compression stockings; 3) and compression + Pycnogenol®. RESULTS: Venous pressure (ambulatory venous pressure, AVP) and refilling time (RT), microcirculatory and clinical measurements were comparable at inclusion. At 8 weeks variations in skin flux (RF), rate of ankle swelling (RAS), skin PO2-PCO2, Analogue Symptomatic Score (ASLS), Venous Disability and severity Scores and local oxidative stress (OS) indicated a statistically significant improvement by Pycnogenol® both as a single supplement and in association with compression in comparison with baseline. Pycnogenol® significantly improved the microcirculation in comparison with compression (P<0.05). The combined effects of Pycnogenol+compression produced the best results in most measurements. The summer study penalized compression - in a very hot summer - with many drops out. No side effects due to supplementation were observed; tolerability was optimal. The tolerability to stocking was less than optimal (70% of compression not correctly used). Pycnogenol® alone was more effective than compression alone. The increase (P<0.05) in skin O2 and the decrease in PCO2 were associated with the decrease in skin flux. The variations in capillary filtration (RAS) were the most important microcirculation changes. RAS is directly associated with swelling, the hallmark of CVI. Pycnogenol® in both Pycnogenol groups significantly improved RAS in comparison with compression only (P<0.05). The decrease in OS in both Pycnogenol® groups was significant in comparison with compression only (P<0.05). A lower OS is an important micro-metabolic indication of a better capillary bed with better nutritional, perfusional exchanges. The clinical measurements followed the patterns of the microcirculation with the supplement groups performing statistically better (P<0.002) than the compression-only. CONCLUSIONS: This "summer registry" study confirms the clinical and microcirculatory efficacy of Pycnogenol in CVI and venous microangiopathy. The study indicates the significant clinical role of Pycnogenol® (both as a single treatment and in association with compression) in the management, treatment and control of this common clinical problem.

Rutosides for treatment of post-thrombotic syndrome.

BACKGROUND: Post-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterised by pain, swelling, and skin changes in the affected limb. One in three patients with DVT will develop post-thrombotic sequelae within five years. Rutosides are a group of compounds derived from horse chestnut (Aesculus hippocastanum), a traditional herbal remedy for treating oedema formation in chronic venous insufficiency (CVI). However, it is not known whether rutosides are effective and safe in the treatment of PTS. This is the second update of the review first published in 2013. OBJECTIVES: To determine the effectiveness (improvement or deterioration in symptoms) and safety of rutosides for treatment of post-thrombotic syndrome (PTS) in patients with DVT compared to placebo, no intervention, elastic compression stockings (ECS) or any other treatment. 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 21 August 2018. SELECTION CRITERIA: Two review authors independently assessed studies for inclusion. Studies were included to allow the comparison of rutosides versus placebo or no treatment, rutosides versus ECS, and rutosides versus any other treatment. Two review authors extracted information from the trials. Disagreements were resolved by discussion. DATA COLLECTION AND ANALYSIS: Data were extracted using designated data extraction forms. The Cochrane 'Risk of bias' tool was used for all included studies to assist in the assessment of quality. Primary outcome measures were the occurrence of leg ulceration over time (yes or no) and any improvement or deterioration of post-thrombotic syndrome (yes or no). Secondary outcomes included reduction of oedema, pain, recurrence of DVT or pulmonary embolism, compliance with therapy, and adverse effects. All of the outcome measures were analysed using Mantel-Haenzel fixed-effect model odds ratios. The unit of analysis was the number of patients. We used GRADE to assess the quality of the evidence for each outcome. MAIN RESULTS: Ten reports of nine studies were identified following searching and three studies with a total of 233 participants met the inclusion criteria. Overall quality of evidence using the GRADE approach was low, predominantly due to the lack of both participant and researcher blinding in the included studies. The quality of the evidence was further limited as only three small studies contributed to the review findings. A subjective scoring system was used to obtain the symptoms of PTS so it was important that the assessors were blinded to the intervention. One study compared rutosides with placebo, one study compared rutosides with ECS and rutosides plus ECS versus ECS alone, and one study compared rutosides with an alternative venoactive remedy. Occurrence of leg ulceration was not reported in any of the included studies. There was no clear evidence to support a difference in PTS improvement between the rutosides or placebo/no treatment groups (OR 1.29, 95% CI 0.69 to 2.41; 164 participants; 2 studies; low-quality evidence); or between the rutosides and ECS groups (OR 0.80, 95% CI 0.31 to 2.03; 80 participants; 1 study ; low-quality evidence). Results from one small study reported less PTS improvement in the rutosides group compared to an alternative venoactive remedy (OR 0.18, 95% CI 0.04 to 0.94; 29 participants; 1 study; low-quality evidence). There was no clear evidence to support a difference in PTS deterioration when comparing rutosides with placebo/no treatment (OR 0.61, 95% CI 0.19 to 1.90; 80 participants; 1 study); with ECS (OR 0.61, 95% CI 0.19 to 1.90; 80 participants; 1 study); or an alternative venoactive remedy (OR 0.19, 95% CI 0.01 to 4.24; 29 participants; 1 study). No clear evidence of a difference in adverse effects between the rutosides and placebo/no treatment groups was seen ('mild side effects' reported in 7/41 and 5/42 respectively). In the study comparing rutosides with ECS, 2/80 could not tolerate ECS and 6/80 stopped medication due to side effects. The study comparing rutosides with an alternative venoactive remedy did not comment on side effects AUTHORS' CONCLUSIONS: There was no evidence that rutosides were superior to the use of placebo or ECS. Overall, there is currently limited low-quality evidence that 'venoactive' or 'phlebotonic' remedies such as rutosides reduce symptoms of PTS. Mild side effects were noted in one study. The three studies included in this review provide no evidence to support the use of rutosides in the treatment of PTS.

Challenges of lymphoedema management in an ageing population.

The risk of developing chronic oedema increases with age. Many factors affect the successful management of this condition, which a robust holistic assessment will identify. This article discusses some of the challenges and complications associated with managing this long-term condition, alongside comorbidities and the effects of ageing. It will consider the implications of wider issues such as social care and the current healthcare economy. The challenges of lymphoedema management can be overcome by offering a collaborative approach to care. This can be achieved by specialist practitioners offering support, advice and guidance on how to ensure satisfactory outcomes for patients in a timely manner.

Designing of advanced smart medical stocking using stress-memory polymeric filaments for pressure control and massaging.

Compression treatment for the patients with chronic disorders such as venous ulcers and varicose veins needs the proper and adequate level of pressure sustainability. This has been a great challenge for health practitioners and stocking manufacturers even till today. There is an imperious need of any research, where internal compression pressure can be controlled or readjusted externally. In line with this, for the first time this study is focused mainly to design and optimize the smart stocking structure by integrating the stress-memory polymeric filament as a main load bearing element. Six different structures were employed to prepare the stocking fabric tubes. All the structures were investigated for pressure analysis and studied the effect of physical parameters such as temperature, strain, and leg radius. It is possible to control the level of massage effect by varying the stocking structures. An empirical relationship is derived, which provides the knowledge for how to control the stocking pressure with structural modifications like never done before. The effect of massage function on blood flow velocity in the popliteal vein on lower limb was objectively measured by Doppler ultrasound scanning. This study also sheds the insight of stocking structural modification for pressure control and provide the benchmark for achieving the efficient compression. This advanced stress-memory polymeric filaments based multifunctional compression stocking provides static pressure, massage effect, and easy size fitting in a more controlled manner for smart compression therapy.

Long-haul flights, edema, and thrombotic events: prevention with stockings and Pycnogenol® supplementation (LONFLIT Registry Study).

BACKGROUND: This registry study evaluated the effects of Pycnogenol® on edema and thrombotic complications in long-haul flights; jet lag was also evaluated. METHODS: Four hundred and fifty subjects at different risk levels for thrombosis, flying in economy class twice a week for more than 8 hours, were included; 295 completed the registry study and were subdivided in 3 groups according to their risk level - low, moderate, or high. The high-risk group also received Aspirin®. A standard management (SM) was used in all groups. In each risk category, three groups were made according to patient management: a Pycnogenol group, a SM group (control), and a stockings group. The groups were comparable at inclusion. No side effects were observed. RESULTS: In the low risk group edema were reduced more (P<0.05) with Pycnogenol and stockings compared to control. Ankle circumference was smaller with Pycnogenol (P<0.05). No thrombosis was detected. D-dimer was negative in Pycnogenol subjects; one subject in the control group had increased values, as did two of the 36 subjects in the stockings group. In the group with moderate risk, edema and ankle circumference were lower in the Pycnogenol group (P<0.05). One deep vein thrombosis (DVT) and one minimal superficial vein thrombosis (SVT) were seen in controls. D-dimer was normal in the Pycnogenol group. In high-risk subjects, edema, and ankle circumference were significantly reduced in the Pycnogenol group (P<0.05). There were no SVT or DVT in the Pycnogenol group. One minimal DVT and one SVT were observed in controls. D-dimer was negative in all Pycnogenol subjects (P<0.05); three post-flight values increased in controls and in four of the 32 subjects in the stockings group. The jet lag score was lower in low-, medium-, and high-risk Pycnogenol subjects (P<0.05). CONCLUSIONS: This registry study indicates that Pycnogenol supplementation reduces edema and may control some thrombotic events.

Evaluation of three different devices to reduce stasis edema in poorly mobile nursing home patients.

BACKGROUND: Prolonged immobility in the sitting position in the elderly is known to produce venous stasis with leg edema and possible skin changes. Compression stockings are often applied for this clinical problem. There is few experienced nursing staff available to supervise the difficult task of stocking application. METHODS: The authors have researched other effective and simple devices that may be suitable alternatives. This article reports the results of three different devices to reduce leg edema, as measured by reduction in leg volume: an electro-stimulation device, an adjustable compression Velcro® wrap and a short stretch bandage, each tested over a two-hour period. RESULTS: In this randomized pilot study including 38 patients, the authors observed no difference in leg volume following electro-stimulation (Veinoplus®). They noted a significant reduction in leg volume following use of the other two devices, more with the adjustable Velcro® wrap compression (Circaid Juxtafit®) than with the short stretch bandage (Rosidal K®). Measurement of the interface pressures created by these two devices and also assessing the stiffness created by applying each device for two hours confirm that pressure is more important than stiffness in the reduction of edema in these particular patients. CONCLUSIONS: This pilot study is to be added to the results of previous published studies showing the efficacy in reducing leg edema of Velcro® adjustable compression wrap and its ease of use.

Treatment for superficial thrombophlebitis of the leg.

BACKGROUND: The optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should aim at preventing venous thromboembolism (VTE), which might complicate the natural history of ST. This is the third update of a review first published in 2007. OBJECTIVES: To assess the efficacy and safety of topical, medical, and surgical treatments for ST of the leg in improving local symptoms and decreasing thromboembolic complications. SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (March 2017), CENTRAL (2017, Issue 2), and trials registries (March 2017). We handsearched the reference lists of relevant papers and conference proceedings. SELECTION CRITERIA: Randomised controlled trials (RCTs) evaluating topical, medical, and surgical treatments for ST of the legs that included people with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in a superficial vein. DATA COLLECTION AND ANALYSIS: Two authors assessed the trials for inclusion in the review, extracted the data, and assessed the quality of the studies. Data were independently extracted from the included studies and any disagreements resolved by consensus. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We identified three additional trials (613 participants), therefore this update considered 33 studies involving 7296 people with ST of the legs. Treatment included fondaparinux; rivaroxaban; low molecular weight heparin (LMWH); unfractionated heparin (UFH); non-steroidal anti-inflammatory drugs (NSAIDs); compression stockings; and topical, intramuscular, or intravenous treatment to surgical interventions such as thrombectomy or ligation. Only a minority of trials compared treatment with placebo rather than an alternative treatment and many studies were small and of poor quality. Pooling of the data was possible for few outcomes, and none were part of a placebo-controlled trial. In one large, placebo-controlled RCT of 3002 participants, subcutaneous fondaparinux was associated with a significant reduction in symptomatic VTE (risk ratio (RR) 0.15, 95% confidence interval (CI) 0.04 to 0.50; moderate-quality evidence), ST extension (RR 0.08, 95% CI 0.03 to 0.22; moderate-quality evidence), and ST recurrence (RR 0.21, 95% CI 0.08 to 0.54; moderate-quality evidence) relative to placebo. Major bleeding was infrequent in both groups with very wide CIs around risk estimate (RR 0.99, 95% CI 0.06 to 15.86; moderate-quality evidence). In one RCT on 472 high-risk participants with ST, fondaparinux was associated with a non-significant reduction of symptomatic VTE compared to rivaroxaban 10 mg (RR 0.33, 95% CI 0.03 to 3.18; low-quality evidence). There were no major bleeding events in either group (low-quality evidence). In another placebo-controlled trial, both prophylactic and therapeutic doses of LMWH (prophylactic: RR 0.44, 95% CI 0.26 to 0.74; therapeutic: RR 0.46, 95% CI 0.27 to 0.77) and NSAIDs (RR 0.46, 95% CI 0.27 to 0.78) reduced the extension (low-quality evidence) and recurrence of ST (low-quality evidence) in comparison to placebo, with no significant effects on symptomatic VTE (low-quality evidence) or major bleeding (low-quality evidence). Overall, topical treatments improved local symptoms compared with placebo, but no data were provided on the effects on VTE and ST extension. Surgical treatment combined with elastic stockings was associated with a lower VTE rate and ST progression compared with elastic stockings alone. However, the majority of studies that compared different oral treatments, topical treatments, or surgery did not report VTE, ST progression, adverse events, or treatment adverse effects. AUTHORS' CONCLUSIONS: Prophylactic dose fondaparinux given for 45 days appears to be a valid therapeutic option for ST of the legs for most people. The evidence on topical treatment or surgery is too limited and does not inform clinical practice about the effects of these treatments in terms of VTE. Further research is needed to assess the role of rivaroxaban and other direct oral factor-X or thrombin inhibitors, LMWH, and NSAIDs; the optimal doses and duration of treatment in people at various risk of recurrence; and whether a combination therapy may be more effective than single treatment. Adequately designed and conducted studies are required to clarify the role of topical and surgical treatments.