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Abstract

A clear understanding of the relationship between venous reflux, clinical venous disease and the effects on quality of life (QoL) remains elusive. This study aimed to explore the impact of venous disease, and assess any incremental direct effect of progressive disease on health-related QoL, with the ultimate aim to model venous morbidity. Consecutive patients with venous disease were assessed for inclusion in the study. Patients with isolated, unilateral, single superficial axial incompetence diagnosed on duplex imaging were included. Clinical grading was performed with the Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification and Venous Clinical Severity Score (VCSS). Patients completed generic (Short Form 36, SF-36(®); EuroQol 5D, EQ-5D(™)) and disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ) QoL instruments. Multivariable regression modelling was performed, taking account of demographic and anatomical factors, to explore the effect of clinical severity on QoL impairment. Some 456 patients with C2-6 venous disease were included, along with control data for 105 people with C0-1 disease. Increasing clinical grade corresponded strongly with deterioration in disease-specific QoL (P < 0.001). This could be stratified into three distinguishable groups: C0-1, C2-4 and C5-6 (P < 0.001 to P = 0.006). Increasing clinical grade also corresponded with deterioration in the physical domains of SF-36(®) (P < 0.001 to P = 0.016), along with EQ-5D(™) index utility (quality-adjusted life year) scores (P < 0.001). Demonstrable morbidity was seen, even with uncomplicated venous disease. The physical impairment seen with venous ulceration was comparable with that seen in congestive cardiac failure and chronic lung disease.

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... Patients with ulcers tend to have poor QoL as a result of inability in daily living activities and social isolation. In literature, the relationship between clinical severity and QoL has been investigated in numerous studies [43][44][45]. Carradice et al. (2011) reported that increasing clinical severity of venous disease was strongly associated with worsening disease-specific QoL [43]. Similarly, Kuet et al. (2014), found a very strong correlation between the VCSS and CIVIQ-14 [44]. ...
... In literature, the relationship between clinical severity and QoL has been investigated in numerous studies [43][44][45]. Carradice et al. (2011) reported that increasing clinical severity of venous disease was strongly associated with worsening disease-specific QoL [43]. Similarly, Kuet et al. (2014), found a very strong correlation between the VCSS and CIVIQ-14 [44]. ...
... In literature, the relationship between clinical severity and QoL has been investigated in numerous studies [43][44][45]. Carradice et al. (2011) reported that increasing clinical severity of venous disease was strongly associated with worsening disease-specific QoL [43]. Similarly, Kuet et al. (2014), found a very strong correlation between the VCSS and CIVIQ-14 [44]. ...
Article
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Purpose To evaluate the relationship between clinical severity and functionality, sleep quality, depression, and quality of life (QoL) in patients with CVI with or without leg ulcers. Methods A total of sixty patients with CVI were enrolled in the study. The patients were C2-6 according to the CEAP classification. All the patients were assessed with Venous Clinical Severity Score (VCSS) for clinical severity, Visual Analogue Scale (VAS) for pain, right and left lower limb (RLL and LLL) circumference measurements for edema, 6-minute-walk test (6-MWT) for functional capacity, Lower Extremity Functional Scale (LEFS) for functionality, Pittsburg Sleep Quality Index (PSQI) for sleep quality, Beck Depression Inventory version I (BDI-I) for depression, and The Quality of Life Questionnaire for Chronic Venous Diseases-20 (CIVIQ-20) for QoL. Results The mean age of the patients was 45.83±13.25 years, and the mean duration of disease was 8.30±7.42 years. There was a significant association between VCSS and VAS-rest/activity, edema-RLL/LLL, PSQI, BDI-I, LEFS, and CIVIQ-20 in patients without leg ulcers. In addition, a significant association was found between VCSS and VAS-rest/activity and CIVIQ-20 in the patient with leg ulcers. Conclusion The current study showed that an association has been found between clinical severity and pain at rest and during activity, edema, sleep quality, depression, lower extremity function, and QoL in patients without ulcers. However, clinical severity has been correlated with only pain at rest and during activity, and QoL in patients with leg ulcers.
... There is not yet a clear explanation for this in the literature. 36 This study is subject to the limitations of only assessing changes in QoL at 4 weeks after treatment and of only studying a single group of patients. Thus, longer follow-up periods cannot be analyzed and there was no control group in which subjects did not undergo intervention. ...
... A permanência de alguns dos pacientes no mesmo CEAP pode ter ocorrido pois alguns graus clínicos são resistentes a mudanças (C4) ou permanentemente estáticos (C5). A explicação disso ainda não está clara na literatura 36 . ...
... Contudo, ao analisarmos a gravidade clínica CEAP nos dois momentos deste estudo, observamos mudança na categoria de alguns pacientes, principalmente no sentido da melhora (redução). Entretanto, na DVC mais grave, mudanças pequenas a moderadas na QV podem permanecer ocultas, levando à variabilidade de resultado, que cresce significativamente com o aumento da gravidade da doença e é responsável por discrepâncias observadas relação entre mudanças na QV e CEAP36 . ...
Article
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Background: Sensitivity determines the efficiency and quality of construction of an assessment measure, but studies of the subject are scarce in the literature. Objective: To evaluate the longitudinal sensitivity of the AVVQ-Brazil to clinical changes after treatment for chronic venous disease (CVD). Methods: A longitudinal intervention study, with 112 chronic venous patients receiving elective treatment, assessed with CEAP, VAPS, AVVQ-Brazil, and VEINES-QOL/Sym at pre-treatment (baseline) and post-treatment (4 weeks). Differences in the scores for the scales at different times were evaluated using Student's t test for paired samples and Wilcoxon's z, which were also used to asses individuals by CEAP grade and assessment time. Effect size, confidence intervals, and partial η2 were used to determine the sensitivity of changes in scale scores over time. Correlations between changes in the scores of the same scales and between different scales were measured using Pearson coefficients, Spearman coefficients, and Kendall's tau-b coefficient. Results: The mean age of the patients was 59.51 years. The majority were female (82.1%), with standing for prolonged periods (49.1%), had completed secondary (22.3%) or higher (25%) education, and had CEAP C2 (28.6%) or C6 (32.1%) clinical severity. The following results were observed: mean scale scores reduced from baseline to post-treatment, except for the Extent of Varicosities domain of the AVVQ-Brazil and the VEINES-QOL/Sym scales; sensitivity was low for the AVVQ-Brazil and its domains and for the VAPS, and was from low to high for the other scales; there were improvements or maintenance of CEAP grade after treatment; and moderate to excellent correlations between changes in scale scores over time. Conclusions: The AVVQ-Brazil is sensitive to longitudinal clinical changes after treatment for CVD and is an important measure for assessment of QoL and of disease severity in Brazil.
... 4 Chronic venous disease is also associated with reduced quality of life, demonstrating progressive impairment with worsening clinical, etiology, anatomy, and pathophysiology (CEAP) clinical classification from C 2 (varicose veins without skin changes) to C 6 (active venous ulcer). [6][7][8][9] The physical impairment observed with venous ulceration (C 5 and C 6 ) has been shown to be similar to that observed with congestive heart failure and chronic lung disease. 9 The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) have collaborated to develop clinical practice guidelines for the management of patients with varicose veins and associated chronic venous diseases. ...
... [6][7][8][9] The physical impairment observed with venous ulceration (C 5 and C 6 ) has been shown to be similar to that observed with congestive heart failure and chronic lung disease. 9 The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) have collaborated to develop clinical practice guidelines for the management of patients with varicose veins and associated chronic venous diseases. 2 Treatment options include conservative treatment (eg, lifestyle advice related to exercise, management of weight and diet, leg elevation, and compression stockings), standard open venous surgery, endovenous thermal ablation with laser or radiofrequency energy, and sclerotherapy. 2 Conservative therapy is typically the first-line treatment for many patients with symptomatic varicose veins. ...
Article
Background: Approximately 24% of adults in the United States have visible varicose veins, and an estimated 6% have evidence of advanced chronic venous disease. The majority of individuals with varicose veins seek treatment because of symptoms, such as aching, throbbing, fatigue, pruritus, ankle swelling, and tenderness, rather than cosmetic reasons. Furthermore, varicose veins are a manifestation of chronic venous insufficiency, which can progress to leg pain, leg edema, chronic skin changes, and nonhealing ulcers. Objective: To assess varicose vein treatment patterns and their corresponding outcomes, including additional treatment rates, disease progression to new ulcers, and associated costs from a US perspective. Methods: We conducted a retrospective claims database study using data from the Truven Health MarketScan database. Adults who were newly diagnosed with varicose veins between January 1, 2008, and June 30, 2010, and met the study inclusion criteria were eligible to participate and were divided into 6 cohorts based on the type of first or initial therapy they received after the index diagnosis date, including surveillance and compression therapy, surgery, laser ablation, radiofrequency ablation, sclerotherapy, or multiple therapies. The patients were followed for 2 years after the index diagnosis date to assess their treatment patterns and outcomes. Results: A total of 144,098 patients met the study criteria. Of these patients, 100,072 (69.5%) were under surveillance for disease progression and/or received compression therapy; 14,007 (9.7%) received laser ablation; 9125 (6.3%) received radiofrequency ablation; 4778 (3.3%) received sclerotherapy; 4851 (3.4%) had surgery; and 11,265 (7.8%) received multiple therapies. During the 2-year follow-up period, among patients receiving interventional treatment, 54.7% of patients received additional interventional treatment (either with the same mode or a different mode from the initial treatment); 30.1% had >1 postintervention claim for symptomatic varicose veins (not including additional procedures) at 8 weeks; and 44.2% had >1 postintervention claim for symptomatic varicose veins at 1 year after the initial interventional therapy. Conclusions: A majority of the patients in the study received conservative management. For patients receiving interventional therapy, the outcomes varied based on the treatment cohort. The surgery cohort was associated with the most favorable outcome regarding the need for additional treatment and evidence of postintervention claims for symptomatic varicose veins, followed by the multiple therapies cohort. A better understanding of these treatment outcomes in the real-world setting may affect new strategies to improve the management of patients with varicose veins.
... Therefore, treatments for CVD should mainly aim at improving quality of life. In the present RCT, as in previous studies 24,[27][28][29][30][31][32] , different management strategies for treating superficial venous incompetence have been proven to be beneficial to quality of life. Whether these positive effects of SAP will prove to be long-lasting is a subject for future research. ...
Article
Full-text available
Background: Current treatment of patients with saphenous trunk and tributary incompetence consists of truncal ablation with concomitant, delayed or no treatment of the tributary. However, reflux of the saphenous trunk may be reversible after treatment of the incompetent tributary. The aim of this study was to determine whether single ambulatory phlebectomy with or without delayed endovenous truncal ablation (SAP) is non-inferior to thermal endovenous ablation with concomitant phlebectomy (TAP), and whether SAP is a cost-effective alternative to TAP. Methods: A multicentre, non-inferiority RCT was conducted in patients with an incompetent great saphenous vein or anterior accessory saphenous vein with one or more incompetent tributaries. Participants were randomized to receive SAP or TAP. After 9 months, additional truncal treatment was considered for SAP patients with remaining symptoms. The primary outcome was VEnous INsufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QOL/Sym score) after 12 months. Secondary outcomes were, among others, cost-effectiveness, perceived improvement of symptoms, and anatomical success. Results: Some 464 patients received the allocated treatment (SAP 227, TAP 237). VEINES-QOL scores were 52.7 (95 per cent c.i. 51.9 to 53.9) for SAP and 53.8 (53.3 to 55.1) for TAP; VEINES-Sym scores were 53.5 (52.6 to 54.4) and 54.2 (54.0 to 55.6) respectively. Fifty-eight patients (25.6 per cent) in the SAP group received additional truncal ablation. Treatment with SAP was less costly than treatment with TAP. Conclusion: One year after treatment, participants who underwent SAP had non-inferior health-related quality of life compared with those who had TAP. Treatment with SAP was a cost-effective alternative to TAP at 12 months. Registration number: NTR 4821 (www.trialregister.nl).
... Lower limb venous disease can be painful and detrimental to mobility, self-esteem and the overall quality of life of individuals with venous leg ulcers having a negative emotional impact and causing debilitating discomfort [1][2][3]. Significantly, quality of life research reveals lower limb venous disease is comparable with higher profile conditions such as myocardial infarction, cardiac failure, and obstructive pulmonary disease [4][5][6]. Global data suggest high prevalence of Lower Limb Venous Disease [7,8], for example the vein consult program [9] held across Eastern Europe, Western Europe, South and Latin America, and the Middle and Far East, found 61.2% of 69,866 patients had signs of lower limb venous disease when screened opportunistically when attending for non-venous related matters. Studies in Germany, Italy and the UK have also revealed prevalence ranging from 7% to 15.8% of people with more advanced stages involving oedema, skin changes and ulceration [10][11][12]. ...
Article
Full-text available
Background Lower limb venous disease can cause significant pain, loss of mobility, and can be detrimental to an individual’s quality of life. Manifestations of venous disease often pose a substantially negative impact on patients and place a high demand on finite healthcare resources. Whilst this problem is internationally recognised, most research and discourse has predominantly focussed on treatment of leg ulceration and prevention of recurrence. Prevention of lower limb venous disease progression to the first ulceration has received far less attention. Overall, the care of this condition appears to rest in the domain of medicine and nursing yet podiatry, a profession with responsibility for the lower limb and foot, is conspicuous by its absence from the literature. Methods An ethnographic approach was used to gather data from 26 participants through observation, semi-structured interviews, and a focus group interview. Qualitative analysis was conducted using the framework approach. Results The findings revealed an identity crisis within the podiatry profession. Evidence emerged of ritual and routine practices that did not include lower limb venous disease. External control over practice limited the professional autonomy of podiatrists determining their own activities. Inter-professional relationships with nursing, and perceptions of boundaries that venous disease was a nursing role were also found to be limiting factors. Conclusions This research revealed that podiatry does not occupy a substantive role in contributing to the early identification and prevention of lower limb venous disease. Policy, education, research and practice changes are all required to enhance the contribution of podiatry to reduce the burden of this disease.
... [1] These manifestations can have significant effects on quality of life. [2] There is a paucity of data from sub-Saharan Africa regarding the management of this condition with venous ablation. ...
Article
Full-text available
Chronic venous disease can be defined as any morphological or functional abnormalities of the venous system manifested by symptoms or signs indicating the need for care. There is a paucity of data from sub-Saharan Africa regarding the management of this condition with venous ablation. This is an early report of the experience of a single centre with a relatively new technique.
... 6,7 CVD presents as a spectrum of signs; lower limb telangiectasias, reticular veins, varicose veins, skin changes and ultimately, ulceration, whilst the most common symptoms are having 'heavy legs', a sensation of swelling of the feet, a sensation 'mild' or 'moderate' degree, 1 with increasing clinical grade being reported to correspond to lower QoL scores. 8 Early epidemiological estimates of CVD were fraught with different methodologies and classification systems. The Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) classification system, developed in 1994, revised in 2004 9 and 2020, 10 sought to provide a framework to facilitate global communication regarding CVD and its management strategies. ...
Article
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Objectives We sought to determine the baseline demographic and clinical characteristics of patients with Chronic Venous Disease (CVD) across the Caribbean, and to evaluate patients’ compliance to conservative therapy and the effectiveness of such therapy in reducing patients’ CVD symptoms. Method Patients were enrolled into the VEIN Act Program, and their demographic data, CVD symptoms (and their intensity) and CEAP C-classification was recorded at the first visit. Patients were prescribed conservative therapy, and symptom intensity and patient compliance and satisfaction evaluated at a follow-up visit. Results We enrolled 193 patients into the study, most of which (76%) were female, between 39–78 years (80%) and within the C 2 -C 4a classes (56.1%). Pain (61.1%) and heaviness (58.5%) were the most common symptoms. Patient compliance to the prescribed treatment was relatively high for all modalities (>75%) and most patients (92.1%) were at least somewhat satisfied with their treatment. Conclusions Patient compliance to conservative therapy for management of CVD is high across the Caribbean, and such therapy is effective in reducing intensity of CVD symptoms.
... CVD has an increasingly negative impact on QoL as the disease progresses [1,3,5,[12][13][14]. Thus, QoL of CVD patients can become very poor, to the extent that QoL in individuals with venous ulceration is comparable with that of patients with congestive heart failure or chronic lung disease [4,15]. Several scales can be used to assess QoL of patients with CVD, including the Chronic Venous Insufficiency Questionnaire (CIVIQ), a validated, self-administered questionnaire that was specifically developed for patients with venous leg symptoms or signs but without active or healed ulceration (C0s-4) [16][17][18]. ...
Article
Aim: This research compared patient and physician perceptions of quality of life (QoL) in C0–4 chronic venous disease (CVD). Methods: Qualitative standardized phone interviews were conducted with 100 patients and 60 specialists from Brazil, China, the Czech Republic, Italy and Russia. Results: In addition to the impact of physical symptoms on QoL, patient interviews revealed a high aesthetic and emotional burden of C0–4 CVD that contributes to social isolation and affects relationships. Physicians were aware of the physical impact but underestimated the other implications of CVD on their patients' QoL. Conclusion: Healthcare professional awareness of the overall impact of CVD on QoL needs improvement. All aspects of QoL should be assessed in order to manage CVD effectively.
... Elastic compression stocking therapy in CVD has been associated with improved venous symptomatology, oedema, skin changes (5)(6)(7)(8), and with the prevention of ulcer recurrence (9). The complications negatively impact patients' quality of life (10)(11)(12). Furthermore, the associated health care burden is substantial and is expected to increase as a result of aging of the global population (especially for CVD) (13)(14)(15). ...
Article
Full-text available
Objective Elastic compression stocking (ECS) therapy is commonly used in patients with deep venous thrombosis (DVT) and chronic venous disease (CVD). The provision of ECS therapy is complex, and studies indicate a lack of practical guidance and suboptimal collaboration among health care professionals. We aimed to reach consensus on critical issues of ECS therapy among the involved health care professionals and patients. Methods A three-round modified Delphi analysis was performed in the Netherlands in which 56 health care professionals (internists, dermatologists, general practitioners, emergency room nurses, home care nurses, medical stocking suppliers, and occupational therapists) and seven patients were invited. The 21 statements included in this analysis were based on information collected from a previously conducted Functional Resonance Analysis Method and Realist Evaluation. We used 7-point Likert scale questions and a 75% threshold for consensus. Results Of the 63 persons invited for this study, 59 (94%) agreed to participate and responded in the first questionnaire round; of whom 52 were health care professionals and seven were patients (five DVT and two CVD). The overall response rate for the three questionnaire rounds was 91%. After completion of the rounds, full consensus was achieved on 19 out of 21 statements. No consensus was reached on the need for a follow-up appointment for CVD patients and who should be responsible to determine the ECS type (custom-made or standard). Conclusion We identified 19 consensus-driven recommendations on treatment decisions and collaboration in ECS therapy among an interdisciplinary panel of health care professionals and patients. These recommendations form a basis for consensus-driven optimization of ECS therapy and should ideally be incorporated in a general cross-domain protocol for ECS therapy in patients with DVT and CVD.
... Chronic venous incompetence is a common condition with severe impact on quality of life (QoL) even in early disease stages. [1][2][3] Reflux time (RT) derived by duplex ultrasound (DUS) is recommended by the European guidelines for diagnosis of venous incompetence. 4 RT is useful for identifying venous reflux but does not show the extent of reflux and has poor relation to disease severity. ...
Article
Objectives: To evaluate the relation of quantitative Duplex ultrasound (DUS) and strain gauge plethysmography (SGP) parameters with clinical severity and quality of life in patients with superficial venous incompetence. Methods: DUS volume flow and distal SGP refilling times (T50 and T90) were evaluated in 152 patients (164 Limbs) with superficial incompetence. Clinical severity and quality of life were evaluated with C of the CEAP classification, venous clinical severity score (VCSS), Aberdeen varicose vein questionnaire (AVVQ), and EuroQol 5D-3L. Results: Higher DUS volume flow was associated with higher C in CEAP scores. Volume flow was also related to T50 and T90. Shorter T50 and T90 were associated with higher C in CEAP and VCSS. T50 was also associated with EQ-5DVAS. Reflux extension to the foot wase associated with shorter T50 and T90 and higher DUS volume flow. Conclusions: DUS volume flow and SGP refilling times are related with clinical severity and provide quantitative information regarding venous function in patients with superficial incompetence.
... The prevalence of CVD is highest in Western (1) . The QoL of patients with venous ulceration (C6) has been reported to be comparable to that of patients with congestive heart failure or chronic lung disease, suggesting that, if CVD is allowed to progress to severe stages, the QoL of CVD patients can become very poor (2) . A systematic review showed that the burden of varicose veins and treatment practices varies across Europe (3) . ...
Article
Full-text available
Introduction: Chronic venous disease is a prevalent condition that worsens with age and is associated with poor quality of life. The treatment of varicose veins (VV) has multiple alternatives, and different practices across Europe. The aim of this article is to analyze the treatment of very elderly patients with severe forms of chronic venous disease using the VenaSeal technique. Method, Material and Results: Report of 5 very old patients with severe venous insufficiency treated with VenaSeal in 2021. Clinical case 1: A 86-year-old woman, with untreated bilateral varicose veins and recurrent ulcers, was observed in consultation, complaining of severe pain in left leg with an doppler ultrasound (DUS) showing bilateral great saphenous vein (GSV) insufficiency. An outpatient basis treatment of the left great saphenous vein with VenaSeal associated with phlebectomies was performed in the left side. After 6 months of follow-up, she is asymptomatic with small areas of repermeabilization of the proximal trunk of GSV. Clinical case 2: A 85-year-old man was observed in consultation describing two episodes of varicorrhagia in his right leg and and DUS with bilateral great saphenous vein insufficiency. An outpatient basis treatment of the right great saphenous vein with VenaSeal associated with varicose veins foam esclerotherapy DUS guided was performed. After a 3-month follow-up, the patient is asymptomatic with the imaging control showing occlusion of the trunk of the great saphenous vein. Clinical case 3: A 97-year-old woman was observed in consultation complaining of severe pain in left leg associated with an ulcer with severe interference with her quality of life and a DUS with bilateral great saphenous vein insufficiency. An outpatient basis treatment of the left great saphenous vein with VenaSeal associated with varicose veins foam esclerotherapy DUS guided was performed. After a 2-month follow-up, the patient is asymptomatic with a healed ulcer, with the DUS control showing occlusion of the great saphenous trunk. Clinical case 4: A 95-year-old woman was observed in consultation describing bilateral severe pain and ulcers in both legs and DUS with bilateral great saphenous vein insufficiency. An outpatient basis treatment of bilateral great saphenous vein with VenaSeal associated with varicose veins foam esclerotherapy DUS guided was performed. After 1-month follow-up, she is asymptomatic with healed ulcers and has occlusion of the right GSV´s trunk and areas of repermeabilization of left GSV´s trunk. Clinical case 5: An 84-year-old woman was observed in consultation with severe pain and severe pruritus of the left leg and a DUS with left GSV insufficiency. An outpatient basis treatment of the left GSV with VenaSeal associated with phlebectomies was performed. After 1 month of follow-up, the patient is asymptomatic with occlusion of the proximal left GSV´s trunk. Discussion /Conclusion: Treatment with Venaseal is not considered in the 2015 Guidelines of the ESVS, however the VeClose Study compared VenaSeal with radiofrequency ablation and reported equivalent improvement in symptoms scores and GSV occlusion. VenaSeal treatment doesn´t require use of elastic compression after surgery and allows return to routine activity immediately, so it may be a good therapeutic option in this age group of patients with high clinical risk. In our experience, VenaSeal resulted in complete resolution of the symptoms and ulcers in the short term. However, a complete occlusion of GSV was not observed in all cases, so new studies and protocols doses can be necessary.
... Chronic venous insufficiency is a progressive disease with a high cost of care that may affect the quality of life of patients. 15 Minimally invasive procedures were broadly applied in the past decade as an alternative to traditional surgery. 4,7 However, thermal ablation methods have been related to skin burns and superficial nerve damage, as well as ecchymosis, hematoma, discomfort, and sensory nerve damage. ...
Article
Objectives The present study was aimed to evaluate the efficacy and early outcomes of n-butyl cyanoacrylate (NBCA) ablation in small saphenous vein (SSV) insufficiency. Methods In this single-center, retrospective, single-arm study, NBCA ablation was performed in 80 patients with SSV insufficiency between September 2018 and May 2020. Primary outcomes (anatomic success rate and occlusion rate) and secondary outcomes (VCSS and AVVQ scores) of the patients were analyzed. Results No technical failure and device-related complications were encountered. Anatomic success rate was 100% after procedures. Each treated SSV was occluded on colored Doppler ultrasonography immediately after the procedure, and all veins remained occluded at 2 weeks after the procedure. Partial recanalization was observed in five patients at 12-month follow-up. Kaplan–Meier analysis revealed an occlusion rates at 6 months and 12 months follow-up were 97.5% and 93.75%, respectively. The mean pretreatment VCSS (4.72 ± 2.04) decreased to 1.61 ± 0.93, 0.87 ± 0.58, and 0.73 ± 0.52 at 2 weeks, 6 months, and 12 months after treatment, respectively ( p < .001). The mean pretreatment AVVQ score (11.92 ± 2.23) decreased to 8.2 ± 1.89, 4.2 ± 1.16, and 3.32 ± 1.19 at 2 weeks, 6 months, and 12 months after treatment, respectively ( p < .001). The Clinical, Etiologic, Anatomic, and Pathophysiology clinical classification at 12 months demonstrated a significant reduction in disease severity compared with preoperative values ( p < .001). There was no mortality and major adverse events including anaphylaxis and pulmonary thromboembolism (PTE) related to procedure after follow-ups. Moreover, there were no symptoms or signs of any sural nerve injury and no cases of skin necrosis, infection, or hyperpigmentation. In addition, no hematoma, deep venous thrombosis, and hypersensitivity reactions were observed. Phlebitis-like abnormal reaction was observed in three patients (3.8%). Conclusions In conclusion, in patients with SSV insufficiency, NBCA ablation with VenaBlock® system appears to be an effective and reliable treatment method. At the 12-month follow-up, the NBCA of SSVs showed a low recanalization rate and had a satisfactory improvement on the VCSS and AVVQ scores.
... Chronic venous insufficiency of the lower limbs is a common disease, with a prevalence of superficial vein reflux of 21%, which increases linearly with age. 1 Chronic venous insufficiency is mainly caused by saphenous vein insufficiency and has been associated with decreased general and disease-specific quality of life. [2][3][4] Minimally invasive techniques with local anesthesia, such as radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), have replaced the traditional saphenofemoral ligation and stripping. 5 However, the use of these endothermal ablation techniques has been associated with the risk of skin burns, nerve injury, and prolonged pain. ...
Article
Full-text available
Objective To review and analyse the currently available literature on Flebogrif and define its role in the global varicose vein treatment devices market. Methods A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies were eligible if they included patients treated with Flebogrif for saphenous vein incompetence, were published in English, and had full text available. Methodologic quality of the articles was assessed using the Methodological Index for Non-Randomized Studies (MINORS) score. A random-effects model was used to estimate the primary outcome of anatomical success, defined as occlusion rate of the treated vein. The estimate is reported with the 95% confidence interval (CI). Secondary outcomes were clinical success, complication rate, pain during and after the procedure, and time to return to work. Results Five articles met the inclusion criteria, reporting 348 procedures in 392 patients. Four studies reported the 3-month anatomical success and three studies reported the 12-month anatomical success. The pooled 3-month anatomical success rate was 95.6% (95% CI, 93.2%-98.0%). The 12-month anatomical success rate was 93.2% (95% CI, 90.3%-96.1%). The only major complication reported within 3 months was deep venous thrombosis, which was seen in 0.3% of the patients. The minor complications thrombophlebitis and hyperpigmentation were seen in 13.3% to 14.5% and in 3.3% to 10.0%, respectively, within 3 months. The methodological quality of the studies included was moderate. Conclusion MOCA using the Flebogrif device is a safe and well-tolerated procedure for the treatment of saphenous vein insufficiency. However, well-designed studies of sufficient sample size and follow-up are required to compare the effectiveness with other endovenous treatment modalities and define the definitive role of the Flebogrif device.
... Together, these factors result in negative QoL effects as severe as those seen in other life-limiting chronic conditions, such as congestive cardiac failure and chronic obstructive pulmonary disease. 6 VLU presents a significant burden to the healthcare service. 7 Up to 50% of district nurse time is spent caring for people with chronic wounds, of which 70% will be venous in origin. ...
Article
Full-text available
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.
... Chronic venous insufficiency is a progressive disease which may impair the quality of life of the individuals with high treatment costs. [19] It is estimated that CVI affects more than 25 million adults in the US and more than six million with severe venous disease. [1] Over the past decade, minimally invasive techniques such as EVTA, radiofrequency or laser ablation and UGFS have been widely adopted as an alternative to conventional surgical interventions. ...
... Untreated, varicose veins progress to more severe forms of CVD in 32% of patients over 6 years, 7 while the incidence of DVI or DVO is expected to increase by 33% over 5 years, 8 highlighting the potential future burden of venous disease. CVD yields important negative effects on quality of life and result in a significant expenditure of the national healthcare budget, 9,10 particularly if it progresses to ulcerative disease. As such, interventions to help manage these conditions and their symptoms, are required. ...
Article
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Background This randomised controlled trial investigates the dosing effect of neuromuscular electrical stimulation (NMES) in patients with chronic venous disease (CVD). Methods Seventy-six patients with CEAP C3-C5 were randomised to Group A (no NMES), B (30 minutes of NMES daily) or C (60 minutes of NMES daily). Primary outcome was percentage change in Femoral Vein Time Averaged Mean Velocity (TAMV) at 6 weeks. Clinical severity scores, disease-specific and generic quality of life (QoL) were assessed. Results Seventy-six patients were recruited - mean age 60.8 (SD14.4) and 47:29 male. Six patients lost to follow-up. Percentage change in TAMV (p<0.001) was significantly increased in Groups B and C. Aberdeen Varicose Veins Questionnaire Score (-6.9, p=0.029) and Venous Clinical Severity Score (-4, p-0.003) improved in Group C, and worsened in Group A (+1, p=0.025). Conclusions Daily NMES usage increases flow parameters, with twice daily usage improving QoL and clinical severity at 6 weeks in CVD patients.
... It is very important to be aware that by design, CEAP does not measure the deleterious health impacts of CVD and there is no evidence of validity for using it to make insurance coverage decisions or ration healthcare. [17][18][19] ...
... Lower limb chronic venous insufficiency (CVI) is a common problem that affects approximatively one quarter of the Western population and has been associated with decreased general and health-related quality of life (QoL). [1][2][3] Superficial venous insufficiency has most often occurred secondary to saphenofemoral junction or great saphenous vein (GSV) truncal incompetence. However, in 10% to 15% of cases, venous disease will be secondary to isolated saphenopopliteal junction (SPJ) or small saphenous vein (SSV) reflux. ...
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Objective: The aim of the study is to investigate the early results of mechanochemical ablation (MOCA) for the treatment of small saphenous vein (SSV) incompetence. Methods: This is a single-center, retrospective analysis of a prospectively collected database of 60 patients treated with MOCA for single-axis SSV incompetence. All procedures were performed under local anesthesia using the ClariVein® catheter (Merit Medical, South Jordan, Utah, USA) combined with 2% Polidocanol and, where appropriate, additional micro-phlebectomies. The primary study endpoint was to assess the SSV occlusion rate at the 1-month, 6-month, and 1-year follow-ups. Secondary endpoints included the evaluation of the Venous Clinical Severity Score (VCSS), quality of life assessment (QoL), peri-procedural pain, and further complications after the intervention and over time. QoL was assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ). Pain was measured on a 100-mm visual analog scale (VAS). Results: Technical success was achieved in 100% of cases. The mean VAS score on the first post-operative day was 15 mm. No major events were recorded. In particular, no neurological complications or deep vein thrombosis was observed. Minor complications included ecchymosis in 3.3% of cases (2/60), transient phlebitis of the SSV in 5% of cases (3/60) and itching in 3.3% of cases (2/60). At the 1-month follow-up the occlusion rate was 100% (60/60), at the 6-month follow-up 98.3% (57/58), and at the 1-year follow-up 92.6% (50/54). The median VCSS significantly decreased from 5 [interquartile range (IQR) 3-6] at baseline to 2 (IQR 1-4) at the 1-month follow-up (p < .001), to 1 IQR (1-2) at the 6-month follow-up (p < .001), and 1 (IQR 0-1) at the 12-month follow-up (p < .001). The mean AVVQ score improved from the baseline score of 25 ± 14.61 to 15.81 ± 13.76 at the 1-month follow-up (p < .001), to 9.81 ± 7.42 at the 6-month follow-up (p < .001), and to 4.73 ± 3.32 at the 12-month follow-up (p < .001). Conclusions: MOCA is a feasible, safe, and painless procedure for the treatment of SSV incompetence with an occlusion rate of 92.6% at the 1-year follow-up. No sural nerve injuries or other major complications were observed. The procedure also shows good clinical results and a positive impact on patients' QoL.
... Furthermore, the quality of life of patients with varicose veins decreases with the increase of clinical grade (is invers proportionally correlated with the clinical stage at admission in hospital (Gloviczki et al 2011 andMoore et al 2013). The prevalence of chronic venous insufficiency is higher in females (<1% to 40%) compared with males (<1% to 17%) with a similar pattern of prevalence of varicose veins (females:males = <1% to 73%:2% to 56%) (Carradice et al 2011). The main risk factors for varicose veins as reported in the specialty literature are family history, age, gender, previous junction), saphenous vein stripping or phlebectomy, as well as minimally-invasive methods (such as foam sclerotherapy, endovenous laser ablation (EVLA) or radiofrequency ablation) represent other treatment options (Nitin et al 2016). ...
Article
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Abstract. Introduction. Recurrent varicose veins (RVV) are a common complication after varicose vein treatment, regardless of the applied therapeutic method.The aim of the present study was to establish the role of Doppler ultrasound (DUS) in the assessment of RVV in patients treated with endovenous laser ablation (EVLA) of the great saphenous vein varices (GSV), as compared to conventional surgical treatment. Material and method. Patients with conventional surgical treatment, interruption of the saphenofemoral junction (crossectomy), saphenectomy (stripping of the great saphenous vein), or/and phlebectomies were eligible for inclusion in the study. Also, patients with endovenous laser treatment performed on the GSV, too, under ultrasound guidance, were eligible. RVV were assessed in both groups, 2 years postoperatively, by DUS examination. Results. One hundred and thirty-eight patients with RVV were included in the study. Seventy four patients had conventional surgical intervention (group 1) for varicose veins and sixty-four had laser endovenous intervention (group 2). Ultrasound-detected varicose recurrence was present in all of the patients in our study, but only 16.66% was concomitantly present the clinical recurrence (clinically manifest). The differences in postoperative results between the two treatment methods during our study were not statistically significant. Conclusions. DUS is the golden standard in the diagnosis of RVV consecutive to interventions on the superficial venous system. Because ultrasound detected reflux is not always accompanied by clinically manifest symptomatology in RVV, careful and periodic ultrasound monitoring of the patients with chronic venous disease is necessary. Key Words: recurrent varicose veins, ultrasound detected recurrence, clinical recurrence.
... A venous leg ulcer (VLU) as a result of chronic venous disease (CVD) occurs in approximately 0Á3% of the Western adult population. 1 The incidence might seem low, but the impact of a VLU is high, as patients with a VLU have a significantly lower quality of life (both generic and disease specific) than patients with an earlier stage of CVD. [2][3][4][5] Patients with CVD have increased ambulatory venous pressure and decreased venous outflow due to obstruction in the veins, weakened vein walls or vein valves, or impaired function of the calf muscle pump. Symptoms of CVD start mild, with reticular veins and varicose veins; however, they can progress to more severe symptoms like oedema, skin changes and eventually a VLU. ...
Article
Background: A Venous Leg Ulcer (VLU) has a significant negative impact on quality of life. Prevention for a VLU is not yet imbedded in clinical practice because risk factors for developing a first VLU are not well-known. Objectives: The objective was to further explore the progression of Chronic Venous Disease (CVD) into a first VLU from a patients' perspective. Methods: A qualitative study using semi-structured interviews was conducted amongst male and female patients with a VLU. Patients from primary and secondary care, under and over 50 years of age and patients with first and recurrent VLUs where included. The interviews where transcribed and analysed using a narrative approach to a thematic analysis. Transcripts where organised in a chronological order and an iterative process was used to code the transcripts. Results: Four key-themes and the connections made between them emerged from the eleven narratives on the progression of CVD towards a first VLU: 'Comorbidity', 'Mobility', 'Work & Lifestyle', and 'Acknowledgement of CVD'. Comorbidity was linked to a reduced Mobility and a late Acknowledgement of CVD. Comorbidity also affected Work & Lifestyle and vice versa. Work & Lifestyle affected Mobility and was linked to the Acknowledgement of CVD. Conclusion: A reduction in Mobility as a result of Comorbidity and Work & Lifestyle occurred before the VLU developed. Patients did not recognise symptoms of CVD and did not acknowledge the chronicity of CVD. Health Care Professionals should be aware of reductions in mobility and the knowledge deficit in patients with CVD.
... Patients with varicose veins may also experience other venous diseases, such as edema, skin changes, and ulcers (4,5). In the surveys conducted in low-income countries, resource allocation has been considered to be of utmost importance for the effective treatment of varicose veins (6), and the patients with poor quality of life are speculated to reap the maximum benefits from the treatment. ...
Article
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Introduction: Lower-limb varicose is a common disorder, which is caused in some occupations and is exacerbated over time, imposing direct and indirect costs on individuals and the community. The present study aimed to validate the Persian version of Aberdeen varicose vein questionnaire (AVVQ). Methods: This cross-sectional study was conducted on 75 patients with varicose veins referring to Imam Reza Hospital in Mashhad, Iran in 2014. The subjects were selected via census sampling. The AVVQ was translated into Persian, and its reliability and validity were assessed using face, content, criterion, and construct validity and Cronbach’s alpha coefficient for reliability. To evaluate content validity, the content validity ratio (CVR) was calculated, and the criterion validity was determined based on Pearson’s correlation-coefficient. In addition, the correlation of the obtained score of each questionnaire item with the total score was verified. Results: The mean age of the patients was 43±16 years. Content validity was assessed based on Lawshe’s method and CVR index of >0.7. The mean score achieved in the AVVQ was 62.3± 8.8, and significant correlations were observed between the total score of AVVQ and physical domain (P<0.001; r=-0.62), mental domain (P<0.001; r=- 0.39), and mean total score of SF-36 (P<0.001; r=-0.56). Moreover, the Cronbach’s alpha for the internal consistency of the questionnaire was estimated at 0.71. Conclusion: According to the results, assessment of the score of quality of life in varicose patients could be an effective approach to the development of proper interventions to improve their quality of life.
... With the rising prevalence of venous diseases, QoL in an increasing number of patients can also be expected to decline. The QoL of patients with C6/venous ulceration has been reported to be comparable to that of patients with congestive heart failure or chronic lung disease, suggesting that, if CVD is allowed to progress to severe stages, the QoL of CVD patients can become very poor [15]. Indeed, QoL is lower in patients with recurrent VVs than in the general population, and patients with recurrent VVs scored lower than normal in all eight scales of the short-form health survey (SF-36) [16]. ...
Article
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Chronic venous disease (CVD) is a prevalent condition that tends to worsen with age. Patients initially seek treatment to relieve symptoms of leg pain, discomfort, heaviness and swelling, all of which impact their quality of life. As the disease increases in severity to include varicose veins, skin changes, and venous ulcer, the demand for treatment increases while the quality of life further diminishes. The prevalence of CVD is highest in Western countries where it already consumes up to 2% of healthcare budgets. With the aging of the global population, the prevalences of CVD and severe CVD are projected to increase substantially, foretelling unsustainably large increases in the healthcare resources and costs needed to treat CVD patients in the coming decades. Effective venoactive drug treatments and ablation procedures are available that provide symptom relief, improve quality of life, slow disease progression, and promote ulcer healing. In addition, venoactive drug treatments may be highly cost-effective. However, there is evidence that physician awareness of CVD is suboptimal and that many patients with CVD are not being treated or referred to specialists according to established guidelines. To decrease this treatment gap and prevent unnecessary disease progression, international guidelines are available to help physicians consider CVD treatment options and refer patients when warranted. Improved disease awareness and appropriate early treatment may help reduce the coming burden of CVD.
... 1,2 The physical symptoms of uncomplicated varicose veins impact significantly upon health-related quality of life (HRQoL). 3 Disease progression can lead to irreversible skin damage in 10% of the population and venous ulcers in 1-2% of adults throughout their lifetime; 2,4-6 those patients progressing to ulceration have a profound deterioration in HRQoL. National and international guidelines based on safety, clinical and cost-effectiveness recommend endovenous thermal ablation (EVTA) as the first-line treatment modality for patients with SVI. ...
Article
Background Mechanochemical ablation is an innovative non-thermal method of treating symptomatic axial superficial venous incompetence. This is a single-centre cohort study aiming to investigate the technical efficacy and clinical effectiveness at one year. Methods Patients with primary, unilateral, symptomatic axial incompetence were offered treatment with mechanochemical ablation using ClariVein® with 1.5% sodium tetradecyl sulphate. Assessments including clinical examination, duplex ultrasound and patient-reported health-related quality of life were performed at baseline and weeks 1, 6, 26 and 52. Results Thirty-two patients were recruited to the study. Complete target vein occlusion at one year was found in 21 (75%) patients. Six patients (21.4%) required secondary procedures, of which three had axial endovenous thermal ablation and three required ambulatory phlebectomy with perforator ligation. There was a significant improvement in the median (interquartile range) Venous Clinical Severity Score from baseline 6 (5–8) to a score of 1 (0–2) at one year (p < 0.001). There was also a significant improvement in health-related quality of life, both generic (p = 0.001) and disease specific (p < 0.001). One patient (3.1%) had a post-procedural non-fatal pulmonary embolus. Conclusions Mechanochemical ablation is a feasible and effective treatment for superficial venous incompetence. When using consensus definitions for anatomical closure, results for mechanochemical ablation may be less favourable than previously reported. Further studies are required to compare clinical and technical outcomes following mechanochemical ablation to other methods of endovenous ablation.
... Patients' satisfaction and postoperative QoL play a very important role for the assessment of venous disease severity and treatment success. 29 Besides a significant improvement of the clinical aspect, based on CEAP-C, we observed postoperative severity scores (HVVSS) and QoL levels (CIVIQ-2) almost like those achieved 2 years after endovenous laser ablation or high ligation and stripping for primary varicose veins. 30 In addition, the fact that 93% of the patients in this study would undergo the same surgical treatment again if medically necessary underlines its value and acceptance. ...
Article
Objectives: Neovascularization from the saphenofemoral junction (SFJ) is regarded to be an important cause of clinical recurrence. The ideal treatment of SFJ recurrence is still matter of debate. Barrier strategies have been implemented to improve surgical outcome by reducing neovascularization. This study analyses the value of inguinal reoperation for recurrent SFJ incompetence using a combined approach of stump suture technique, removal of neovasculates, cauterization of free endothelium and additional tumescent local anesthesia. Materials and Methods: Patients who underwent groin reoperation for saphenofemoral recurrence were identified from a prospectively collected database and invited to undergo a follow-up examination. The following study objectives were recorded and descriptively analysed: duplex ultrasound detectable repeat reflux at the SFJ, clinical recurrence according to REVAS classification, quality of life, clinical severity of venous disease, and side effects. Results: 83 patients (100 legs) attended the follow-up examination after a median time of 16.2 months. A duplex detected reflux in the groin arising from the common femoral vein was identified in 5% with only one leg showing grade 2 neovascularization according to UIP classification. Moderate clinical recurrence (VAS1-5: 1.6 ± 0.7) was present in 52%. Same site clinical recurrence originating from the SFJ was detected in 3%. Major complications were not observed and the procedure was highly accepted by the patients. Conclusions: This study demonstrates that inguinal reoperation for recurrent saphenofemoral incompetence including a stump suture as barrier has the potential to significantly reduce duplex detected and same site clinical recurrence accompanied by a high patients’ acceptance.
... Patients' satisfaction and postoperative QoL play a very important role for the assessment of venous disease severity and treatment success. 29 Besides a significant improvement of the clinical aspect, based on CEAP-C, we observed postoperative severity scores (HVVSS) and QoL levels (CIVIQ-2) almost like those achieved 2 years after endovenous laser ablation or high ligation and stripping for primary varicose veins. 30 In addition, the fact that 93% of the patients in this study would undergo the same surgical treatment again if medically necessary underlines its value and acceptance. ...
Article
Objectives: Neovascularization from the saphenofemoral junction (SFJ) is regarded to be an important cause of clinical recurrence. The ideal treatment of SFJ recurrence is still matter of debate. Barrier strategies have been implemented to improve surgical outcome by reducing neovascularization. This study analyses the value of inguinal reoperation for recurrent SFJ incompetence using a combined approach of stump suture technique, removal of neovasculates, cauterization of free endothelium and additional tumescent local anesthesia. Materials and methods: Patients who underwent groin reoperation for saphenofemoral recurrence were identified from a prospectively collected database and invited to undergo a follow-up examination. The following study objectives were recorded and descriptively analysed: duplex ultrasound detectable repeat reflux at the SFJ, clinical recurrence according to REVAS classification, quality of life, clinical severity of venous disease, and side effects. Results: 83 patients (100 legs) attended the follow-up examination after a median time of 16.2 months. A duplex detected reflux in the groin arising from the common femoral vein was identified in 5% with only one leg showing grade 2 neovascularization according to UIP classification. Moderate clinical recurrence (VAS1-5: 1.6 ± 0.7) was present in 52%. Same site clinical recurrence originating from the SFJ was detected in 3%. Major complications were not observed and the procedure was highly accepted by the patients. Conclusions: This study demonstrates that inguinal reoperation for recurrent saphenofemoral incompetence including a stump suture as barrier has the potential to significantly reduce duplex detected and same site clinical recurrence accompanied by a high patients' acceptance.
... Venous leg ulceration is a chronic and devastating condition that affects approximately 1% of the adult population in the Western world. 1 It costs up to 198 million sterling pounds in national health care expenditure in the UK alone, 2 significantly affecting , in a negative manner, patients' quality of life. 3 Moreover, venous leg ulcers tend to recur quite frequently, with recurrence rates reaching 70% within a year of healing. 4 With such costs involved and the considerable devastation to patients' lives, it is no surprise that adjunct and alternative therapies to compression therapy (which is considered the golden standard) 5 have been pursued (eg, ultrasound, 6 larval therapy, 7 biomaterials 8 ), with exercise and physical activity promotion also being considered (eg, walking, 9 increased physical activity, 10 resistance exercise 11 ). ...
Article
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Despite exercise being included in the recommended advice for patients with venous leg ulcers, there is a fear shared by clinicians and patients that exercise may be either inappropriate or harmful and actually delay rather than promote healing. Therefore, before implementing a larger‐scale study exploring the effects of a supervised exercise programme in patients with venous ulcers being treated with compression therapy, it is important to assess exercise safety as well as fidelity and progression in a feasibility study. Eighteen participants randomised in the exercise group were asked to undertake 36 (3 times/week for 12 weeks) 60‐min exercise sessions, each comprising moderate‐intensity aerobic, resistance, and flexibility exercise components. For the purposes of this paper, we analysed the data collected during the exercise sessions. The overall session attendance rate was 79%, with 13 of 18 participants completing all sessions. No in‐session adverse events were reported; 100% aerobic components and 91% of resistance components were completed within the desired moderate‐intensity target. Similarly, 81% of aerobic components and 93% of flexibility components were completed within the prescribed duration targets. Our data showed that patients with venous ulcers could safely follow a supervised exercise programme incorporating moderate‐intensity aerobic, resistance, and flexibility components.
... 1e5 Patients with PTS report reduced quality of life (QoL), similar to diseases such as congestive heart failure, diabetes mellitus, and chronic obstructive pulmonary disease. 6,7 In a quarter of patients with deep vein thrombosis the iliac and common femoral veins (CFVs) are involved. When not properly recanalised, this can severely limit outflow, which can occur in up to 70% of patients with iliofemoral deep vein thrombosis. ...
Article
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Objectives: The primary aim was to investigate whether stenting of post-thrombotic iliofemoral obstruction reduces venous hypertension. The secondary aim was to establish whether improvement in haemodynamic parameters impacts on quality of life. Methods: In this prospective observational study, 12 participants with unilateral post-thrombotic obstruction of the iliac and/or common femoral veins (CFVs) underwent a treadmill stress test with invasive pressure measurements in the CFVs and dorsal foot veins of both affected and non-affected limbs. This was performed the day before and 3 months after stenting the obstructed tract. Paired sample t-tests were used to compare the treatment effect and univariable linear regression analysis to determine the association with improvement in quality of life. Results: Before treatment, CFV pressure increased 34.8 ± 23.1 mmHg during walking in affected limbs compared with 3.9 ± 5.8 mmHg in non-affected limbs. This pressure rise decreased to 22.3 ± 24.8 mmHg after 3 months follow up compared with a 4.0 ± 6.0 mmHg increase in non-affected limbs (-26.2 mmHg difference; 95% CI -41.2 to -11.3). No such effect was found in the dorsal foot veins. The VEINES-QOL increased 25.3 ± 11.3 points after stenting and was significantly associated with a decrease in CFV pressure rise during walking (regression coefficient 0.4; 95% CI 0.1-0.6). Conclusion: Stenting of post-thrombotic iliofemoral obstruction significantly reduces venous hypertension in the common femoral vein and correlates with an improvement in the quality of life. Larger studies with a broader range of degree of obstruction need be performed to assess whether pre-stenting pressure measurements can predict post stenting clinical success.
... Additionally, the true nature of progression of venous disease and maximum vein diameter changes are not yet known 42 -44 ; treating a small but symptomatic vein now may prevent more costly treatment and extensive morbidity in the future 45 . Extensive work by Carradice and colleagues 3,46 has demonstrated that increasing clinical severity is associated with increasing symptom loads but, more crucially, that withholding treatment until the onset of chronic venous changes leads to a higher risk of recurrence and a level of irreversible morbidity that could be avoided with treatment based on symptoms. ...
... The fact that increased clinical degree of venous disease was commonly associated with deteriorating health outcomes and QoL has been proven by many studies. Carradice et al. [92] in their study which is conducted with the aim of to explore the impact of venous disease, and assess any gradual direct effect of clinically advanced disease on HRQoL, evaluated 561 patients with the having different clinical degree of venous disease according to CEAP clinical grade. From those, 456 patients had C2-6 and 105 patients had C0-1 clinical degree, which is assumed as a control group. ...
... Additionally, the true nature of progression of venous disease and maximum vein diameter changes are not yet known 42 -44 ; treating a small but symptomatic vein now may prevent more costly treatment and extensive morbidity in the future 45 . Extensive work by Carradice and colleagues 3,46 has demonstrated that increasing clinical severity is associated with increasing symptom loads but, more crucially, that withholding treatment until the onset of chronic venous changes leads to a higher risk of recurrence and a level of irreversible morbidity that could be avoided with treatment based on symptoms. ...
Article
Background: Varicose veins and chronic venous disease are common, and some funding bodies ration treatment based on a minimum diameter of the incompetent truncal vein. This study assessed the effect of maximum vein diameter on clinical status and patient symptoms. Methods: A prospective observational cohort study of patients presenting with symptomatic varicose veins to a tertiary referral public hospital vascular clinic between January 2011 and July 2012. Patients underwent standardized assessment with venous duplex ultrasonography, and completed questionnaires assessing quality of life (QoL) and symptoms (Aberdeen Varicose Vein Questionnaire, EuroQol Five Domain QoL assessment and EuroQol visual analogue scale). Clinical scores (Venous Clinical Severity Score (VCSS) and Clinical Etiologic Anatomic Pathophysiologic (CEAP) class) were also calculated. Regression analysis was used to investigate the relationship between QoL, symptoms and vein diameter. Results: Some 330 patients were assessed before surgery. The median maximum vein diameter was 7·0 (i.q.r. 5·3-9·2) mm overall, 7·9 (6·0-9·8) mm for great saphenous vein and 6·0 (5·2-8·9) mm for small saphenous vein. In linear regression analysis, vein diameter was shown to have a significant association with VCSS (P = 0·041). For every 1-mm increase in vein diameter, there was a 2·75-fold increase in risk of being in CEAP class C4 compared with C2. No other QoL or symptom measures were related to vein diameter. Conclusion: Incompetent truncal vein diameter was associated with increasing VCSS, but not a variety of other varicose vein disease-specific and generic patient-reported outcome measures.
... The prevalence of superficial vein reflux is up to 30% in the adult population and increases linearly with age. 1 Chronic venous incompetence has been associated with decreased general and disease-specific quality of life. [2][3][4] Endothermal ablation (ETA) treatment of the GSV has become the first-line treatment for superficial venous reflux. ETA has the advantage of avoiding general anesthesia, and a shorter operative time and decreased postoperative pain and morbidity compared with open surgery have been reported. ...
Article
Background: Endothermal treatment of the great saphenous vein (GSV) has become the first-line treatment for superficial venous reflux. Nonthermal ablation has potential benefits for acceptability by patients and decreased risk of nerve injury. We performed a systematic review and meta-analysis to evaluate the efficacy of mechanochemical endovenous ablation (MOCA) and cyanoacrylate vein ablation (CAVA) for GSV incompetence. Methods: MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane databases were searched for papers published between January 1966 and December 2016. Eligible articles were prospective studies that included patients treated for GSV incompetence and described the primary outcome. Exclusion criteria were full text not available, case reports, retrospective studies, small series (n < 10), reviews, abstracts, animal studies, studies of small saphenous vein incompetence, and recurrent GSV incompetence. Primary outcome was anatomic success. Secondary outcomes were initial technical success, Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire score, and complications. Results: Fifteen articles met the inclusion criteria. Pooled anatomic success for MOCA and CAVA was 94.7% and 94.8% at 6 months and 94.1% and 89.0% at 1 year, respectively. Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire score significantly improved after treatment with MOCA and CAVA. Conclusions: These results are promising for these novel techniques that could serve as alternatives for thermal ablation techniques. However, to determine their exact role in clinical practice, high-quality randomized controlled trials comparing these novel modalities with well-established techniques are required.
... We use concave reward functions for f and g, where improvements made in worse patient states are more appreciated than improvements made in healthier states. These relationships can often be found in studies that examine patient utility as a function of clinical states [31,32,33,34]. Thus, the functions f and g can be written as ...
Article
There are several different modalities, e.g., surgery, chemotherapy, and radiotherapy, that are currently used to treat cancer. It is common practice to use a combination of these modalities to maximize clinical outcomes, which are often measured by a balance between maximizing tumor damage and minimizing normal tissue side effects due to treatment. However, multi-modality treatment policies are mostly empirical in current practice, and are therefore subject to individual clinicians' experiences and intuition. We present a novel formulation of optimal multi-modality cancer management using a finite-horizon Markov decision process approach. Specifically, at each decision epoch, the clinician chooses an optimal treatment modality based on the patient's observed state, which we define as a combination of tumor progression and normal tissue side effect. Treatment modalities are categorized as (1) Type 1, which has a high risk and high reward, but is restricted in the frequency of administration during a treatment course, (2) Type 2, which has a lower risk and lower reward than Type 1, but may be repeated without restriction, and (3) Type 3, no treatment (surveillance), which has the possibility of reducing normal tissue side effect at the risk of worsening tumor progression. Numerical simulations using various intuitive, concave reward functions show the structural insights of optimal policies and demonstrate the potential applications of using a rigorous approach to optimizing multi-modality cancer management.
... Both the EQ-5D™ and AVVQ measures have been employed in the assessment of patients with varicose veins, and found to correlate with scores corresponding to increasing Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification scores 7,16 . ...
... The AVVQ evaluation includes both symptoms (pain and itching) and clinical signs (oedema, hyperpigmentation, and ulceration). The questionnaire also includes questions related to the effect of the disease on the patient's quality of life, which is highly important in the contemporary studies in the field of phlebology [24]. The total score of the questionnaire ranges from 0 (no effect on the quality of life) to 100 (a maximum effect). ...
Article
Full-text available
Introduction. Even though EVLA is increasingly popular and together with other minimally-invasive techniques is rapidly replacing surgical stripping, surgical treatment is still widely used. Our study aimed to compare the clinical outcomes and the quality of life following either endovenous laser ablation (EVLA) or conventional surgery for varicose veins of the lower limbs. Material and methods. This prospective non-randomised study included 299 patients, who were treated for symptomatic varicose veins of the lower limbs in two centres. In one, 159 patients underwent open surgery (the surgery group), while in the other, 140 patients received the EVLA (the EVLA group). The patients were invited to follow-up evaluations at six weeks, one year, and two years after the surgery. Results. Disease-specific quality of life at six weeks was significantly better in the EVLA group (median AVVQ scores — 3.2 (2.1–8) vs. 9.2 (7.1–13.8), p < 0.001). Similarly, VCSS scores at six weeks were also better in the EVLA group (median VCSS scores — 1 (0–2) vs. 4 (3–6), p < 0.001). Patients in the EVLA group experienced less postoperative pain (p < 0.001), and therefore needed fewer supplementary analgesic drugs (p = 0.007). In addition, patients in the EVLA group managed to return to work and normal activities sooner than those in the surgery group (p < 0.001). No statistically significant differences were found between groups for clinical recurrence, overall satisfaction, rate of complications and secondary procedures. Conclusions. Both treatment techniques yielded similar results in terms of efficacy, clinical recurrence rates and overall patient satisfaction. However, early postoperative results in the EVLA group were superior to those of patients in the surgery group.
Article
Chronic venous disease is a common disease, the prevalence of which increases with age, and can cause debilitating symptoms that adversely affect the quality of life. The risk factors include family history, female sex, obesity, pregnancy, parity, and history of deep vein thrombosis. Moreover, it is associated with venous obstruction, reflux, or both, which, in turn, leads to ambulatory venous hypertension. Chronic venous disease is the leading cause of leg ulcers, which place a significant cost burden on the health care system. Compression therapy remains the cornerstone of treatment, particularly for more advanced disease. Superficial saphenous vein reflux can be associated with significant symptoms. Catheter techniques, both thermal and nonthermal, have demonstrated efficacy and safety in successful closure and symptom improvement. Deep vein obstruction can be broadly divided into thrombotic and nonthrombotic and can lead to symptomatic chronic venous disease. Recanalization using balloons and stents has been increasingly used and studied in such patients. It is critical to develop training opportunities and guidelines to improve evidence-based and appropriate care for cardiologists treating chronic venous disease.
Article
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Background: Siravedha (venesection) a type of bloodletting, is indicated for varicose vein in Ayurveda. Effects of Siravedha manifests at multiple levels from the blood hemodynamics to the Quality of Life of varicose vein patients. Present study was planned to understand the effect of siravedha in varicose vein in terms of all the available subjective and objective parameters which will give a better understanding on the effect of siravedha. Objectives: To evaluate the improvement obtained from siravedha in varicose vein using subjective scales and blood profile. To develop a Mathematical model using outcome measures to predict the effect of siravedha in varicose vein. Materials and methods: Subjective parameters assessed before and after siravedha were Clinical Etiologic Anatomic Pathophysiologic [CEAP] classification, Venous Clinical Severity Score [VCSS], Aberdeen Varicose Vein Questionnaire, scoring of raktadushti (vitiation of blood) symptoms and prakriti (body constitution) assessment. Objective parameters include routine blood examination, Arterial Blood Gas test etc. Results: Correlation between CEAP score and each parameter in cubital and varicose vein was done separately to find the top positively and negatively correlated parameters and 11 parameters were identified. Linear model and polynomial model were developed separately for CEAP score and VCSS score using 11 parameters. It was found that the linear regression model fits for the CEAP score and VCSS score very well which can be used in the varicose vein patients to predict the effect of siravedha in them prior to procedure. Conclusions: Developing multi scale mathematical model helps to understand and integrate the effects of siravedha happening at different levels.
Article
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Background Several diagnostic tests and treatment options for patients with lower extremities varicose veins have existed for decades. The purpose of this systematic review was to summarize the latest evidence of the diagnostic and treatments options to support the forthcoming updates of the clinical practice guidelines on the management of varicose veins for the Society for Vascular Surgery (SVS), the American Venous Forum (AVF) and the American Vein and Lymphatic Society (AVLS). Methods We searched multiple databases for studies that addressed four clinical questions identified by the AVF and the SVS guideline committee about evaluating and treating patients with varicose veins. Studies were selected and appraised by pairs of independent reviewers. Meta-analysis was conducted when feasible. Results We included 73 original studies (45 were randomized controlled trials) and one systematic review from 12,915 candidate references. Moderate certainty of evidence supported the utility of duplex ultrasound (DU) as the gold standard test for diagnosing saphenous vein incompetence in patients with varicose veins and chronic venous insufficiency (CEAP class C2 - C6). High ligation and stripping (HL&S) was associated with higher anatomic closure rates at 30 days and five years when compared to radiofrequency ablation (RFA) and Ultrasound-guided foam sclerotherapy (UGFS) (moderate to high certainty), while no significant difference was seen when compared to endovenous laser ablation (EVLA) at five years. UGFS was associated with an increased risk of recurrence compared to HL&S. EVLA was associated with lower anatomic closure rates at 30 days than cyanoacrylate closure (CAC) and higher rates at one and five years when compared to UGFS. Compared to non-thermal interventions, thermal interventions were associated with lower generic quality of life (QoL) scores and an increased risk of adverse events compared to CAC or N-butyl cyanoacrylate (NBCA) (low certainty). Thermal interventions were associated with a lower risk of recurrent incompetence when compared to UGFS and an increased risk of recurrent incompetence than CAC. The evidence for great saphenous vein (GSV) ablation alone to manage perforator disease was inconclusive. Conclusion The current systematic review summarizes the evidence to develop and support forthcoming updated SVS/AVF/AVLS clinical practice guideline recommendations. The evidence supports duplex scanning for evaluating patients with varicose veins and confirms that HL&S resulted in similar long-term saphenous vein closure rates as EVLA and in better rates than RFA and UGFS. Thermal interventions were associated with inferior generic quality of life scores than non-thermal interventions but had a lower risk of recurrent incompetence than UGFS. The recommendations in the guidelines should consider this information as well as other factors such as patients' values and preferences, anatomical considerations of individual patients, and surgical expertise.
Article
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.
Article
Aim: The purpose of this study was to prove that Detravenol is not inferior by clinical efficacy to Detralex® in the course administration in patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins. Patients and methods: Ours was a prospective randomized open-liable comparative trial aimed at determining efficacy and safety of the two drugs in parallel groups with active control. The trial enrolled a total of 106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins. The patients took the drug during 60 days twice daily. The primary outcome measure of efficacy was reduction of the malleolar circumference upon completion of treatment as compared with the baseline values, with the secondary outcome measures being the dynamics of parameters according to the Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning. Results: The obtained findings demonstrated efficacy of therapy with the use of Detravenol in treatment of patients with chronic venous insufficiency of the lower limbs. The 60-day therapy with the study drug resulted in decreased oedema of the lower extremities: the malleolar circumference reduced averagely by 4%, the composite index of the venous clinical severity score diminished averagely by 50%, and the subjective measure of quality of life increased. Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed. Conclusion: By the primary outcome measure of efficacy (reduction of the malleolar circumference) therapy using the investigational drug proved to be not inferior to therapy with the comparator drug. By the secondary outcome measures the compared therapies appeared equally effective. The study drug and the comparator were found to have a similar safety profile.
Article
Introduction Endovenous mechanochemical ablation (MOCA) is an increasingly popular non-thermal non-tumescent technique used to treat axial reflux in patients with superficial venous incompetence. However, the optimal management of varicose tributaries following this technique is unknown and may impact on patient outcomes. This study compares MOCA with concomitant phlebectomy (MOCAP) versus ablation with sequential phlebectomy if required (MOCAS). Methods Patients with symptomatic Comprehensive Classification System for Chronic Venous Disorders (CEAP C2–C6) unilateral axial reflux were studied. Patient choice determined whether concomitant treatment of varicosities was carried out. The primary outcome was the Aberdeen Varicose Veins Questionnaire (AVVQ) at one year. Secondary outcomes included: Venous Clinical Severity Scores (VCSS), EuroQol 5-Domain quality of life scores, complications, procedure duration, procedural and post-operative pain scores and need for secondary procedures. Outcomes were assessed at baseline and then one week, six weeks, six months and one year post intervention. Results Fifty patients underwent MOCAP and 33 patients MOCAS. The two groups were comparable at baseline. MOCAP was associated with lower (better) AVVQ scores at six weeks (3.4 (0.5–6.0) vs. 6.1 (1.8–12.1); P = 0.009) and at six months (1.6 (0.0–4.5) vs. 3.34 (1.8–8.4); P = 0.009) but by one year the difference was no longer statistically significant (1.81 (0.0–4.5) vs. 3.81 (0.2–5.3); P = 0.099). MOCAP was associated with longer procedural duration (45 min (36–56) vs. 30 min (25–37); P < 0.001) and higher maximal periprocedural pain (31 (21–59) vs. 18 (7–25); P = 0.001). VCSS at all time points were lower in favour of MOCAP (0 (0–1) vs. 1 (0–3); P < 0.001). MOCAP was associated with fewer episodes of clinically significant thrombophlebitis (6 of 50 (12%) vs. 10 of 33 (30%); P = 0.039) and lower numbers of secondary procedures (2 (4%) vs. 6 (18%); P = 0.032). Conclusion Concomitant treatment of tributary varicosities following MOCA improves quality of life and clinical severity, while reducing rates of re-intervention and post-operative thrombophlebitis compared to sequential treatment. The penalty is a modest increase in procedural duration and discomfort. Further evidence from longer-term follow-up is needed.
Article
Objective/background The aim was to summarise the evidence for the relationship between vein diameters and clinical severity, and elucidate the relationship between diameters and health related quality of life (HRQoL) Methods A systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. The MEDLINE and Embase databases were searched from 1946 to 31 August 2018. Reference lists of included studies were searched for further relevant papers. Full text studies in English reporting the relationship between great and small saphenous vein diameters and clinical severity and/or HRQoL scores measured using validated instruments were included. All study designs were included. Studies that did not include relationships between these parameters, non-English studies, and studies focusing on non-truncal veins were excluded. Two reviewers independently performed the study selection, data extraction, and risk of bias assessment. Results Eleven eligible studies were identified, reporting on 2,732 limbs (range 22–681). Four studies correlated truncal vein diameter with both clinical severity and HRQoL, while seven reported only on clinical severity measures. Multiple instruments were used to quantify HRQoL and clinical severity. Seven studies assessed the relationship with CEAP class, with the majority observing a positive correlation between vein diameter and disease severity. Four studies found weak correlations with VCSS, with one showing correlations with VCSS components. No significant relationship between diameters and HRQoL scores was reported. One study also revealed no correlation with Aberdeen Varicose Vein Questionnaire improvements post-treatment. The majority of studies failed to include C0 and C1 participants. Conclusions While further studies are required to improve the level of evidence, the existing literature suggests that truncal vein diameters correlate with clinical severity. Diameters are a poor predictor of HRQoL, with no relationship to patients’ perceived impact of chronic venous disease. As such, vein diameter should not be used as a measure to decide who needs venous intervention.
Article
Objectives This study aims to present the early results of a prospective study of the use of novel n-butyl-2 cyanoacrylate (VenaBlock)-based nontumescent endovenous ablation with a guiding light for the treatment of patients with varicose veins. Methods Five hundred and seventy-three patients with lower-limb venous insufficiency were treated within in the previous four years. The study enrolled adults aged 21–70 years with symptomatic moderate to severe varicosities (C2–C6 patients clinical, etiological, anatomical, and pathophysiological classification) and great saphenous vein reflux lasting longer than 0.5 s with great saphenous vein diameter ≥ 5.5 mm assessed in the standing position. Duplex ultrasound imaging and clinical follow-up were performed on the third day, first month, and sixth month. Clinical, etiological, anatomical, pathophysiological classification; venous clinical severity score; and completed Aberdeen varicose vein questionnaire were recorded. Results Five hundred and seventy-three patients aged 21–70 years with lower-extremity venous insufficiency treated with n-butyl-2. The mean treatment length was 30.6 ± 5.3 cm and the average n-butyl-2 delivered was 1.2 ± 0.3 ml. The mean procedure time was 10.8 ± 4.7 min. There was no deep venous thrombosis, pulmonary embolism, or paresthesia. We observed ecchymosis in eight patients (1.4%) at the entry site at the third day follow-up. Phlebitis was encountered with 10 (1.8%) patients. No skin pigmentation, hematoma, paresthesia, deep-vein thrombosis, or pulmonary embolism was observed. Procedural success was 100%, and complete occlusion was observed after treatment, at the third day follow-up and at first month. Kaplan–Meier analysis yielded with overall clinical recurrence-free rate after a mean follow-up of 23.96 months was 99.38%. All patients had significant improvement in venous clinical severity score and quality-of-life scores postoperatively ( p < 0.0001). Venous clinical severity score scores at preintervention and 24th month were 5.8 ± 1.0 (range 4–8) and 0.6 ± 0.6 (range 0–4), respectively ( p < 0.0001). Aberdeen varicose vein questionnaire scores at preintervention and 24th month were 19.7 ± 6.4 (range 9–30) and 4.4 ± 1.1 (range 1–9), respectively ( p < 0.0001). Conclusions The procedure appears to be feasible, safe, and efficient in treating the great majority of incompetent great saphenous veins with this technique.
Article
Venous Leg Ulcers (VLU) occur in about 1% of the Western population. A VLU takes three to twelve months to heal, it recurs often, and it has a negative impact on the quality of life. The risk factors for the development of a first VLU are not well‐understood and prevention of a first VLU therefore remains underappreciated. The aim of this study is to identify risk factors for developing a first VLU in adults (aged >18 years) by searching the literature. We searched the Cochrane Library, Pubmed, Cinalh, and Narcis to identify studies that investigated risk factors in developing a VLU. The last search was performed in January 2018. Two reviewers independently reviewed the abstracts and full‐text articles, and assessed the methodological quality of the included studies. Results of studies using duplex scanning, and comparing participants with and without VLUs were included in the qualitative analysis. Where possible a quantitative meta‐analysis was conducted. We found five studies that investigated the relation of several risk factors with VLU development. The methodological differences of the studies made it impossible to perform a quantitative analysis. The risk factors: higher age (four studies), higher Body Mass Index (four studies), low physical activity (four studies), arterial hypertension (four studies), deep vein reflux (three studies), deep venous thrombosis (three studies) and family history of VLU (three studies) were significantly associated with a VLU in the majority of the studies. To what extent they influence the development of a VLU remains unclear because of the limited number of studies that investigated the association of these risk factors with VLU development, and the heterogeneity of these studies. Further studies are needed to confirm the association of these risk factors with the development of a VLU and to explore overweight and low physical activity in more detail. This article is protected by copyright. All rights reserved.
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Background: Varicose veins impair quality of life and can lead to chronic leg ulcers. National Institute for Health and Care Excellence (NICE) guidelines (CG168) set out evidence-based standards for patient management. In England, Clinical Commissioning Groups (CCGs) fund NHS care within their locality. The objective of this study was to evaluate CCGs’ commissioning policies and compare them with CG168. Methods: Searches were made for the published policies of all 206 English CCGs. They were reviewed for compliance with NICE guidelines and the associated quality standard. Areas of disagreement were analysed for themes. Results: Some 203 CCGs (98⋅5 per cent) had a published policy and 190 (93⋅6 per cent) of these were published after publication of CG168. Only 73 of the policies (36⋅0 per cent) were compliant with CG168. Treatment was restricted on the basis of clinical disease severity in 119 CCGs (58⋅6 per cent); 29 (14⋅3 per cent) stipulated delay of treatment using a ‘trial’ of conservative treatment; 22 (10⋅8 per cent) used lifestyle-related factors such as BMI and smoking status to ration treatment. Treatment was commissioned for uncomplicated symptomatic varicose veins in 87 CCGs (42⋅9 per cent), but some applied additional rationing mechanisms; 109 CCGs (53⋅7 per cent) would treat oedema, 183 (90⋅1 percent) would treat skin and soft tissue damage, 202 (99⋅5 per cent) healed ulceration, and all would allow active ulcers to be treated. Discussion: The majority of CCGs in England have commissioning policies that contradict NICE guidelines. Rationing strategies include disease severity, delay and patient lifestyle-related factors, creating unwarranted geographical variation for varicose vein treatment, disregarding the NHS Constitution for England, and perhaps leading to an increase in costly treatment of chronic complications in the long term.
Article
This study aimed to evaluate the effect of EMLA 5% cream applied to painful chronic leg ulcers (CLUs) as a primary dressing on wound healing and health-related quality of life (HRQoL). A pilot, parallel-group, nonblinded, randomized controlled trial was conducted in 6 community nursing procedure clinics in New South Wales, Australia. A total of 60 participants with painful CLUs of varied etiology were randomly assigned to the intervention (EMLA daily for 4 weeks as a primary dressing, followed by usual care) or usual care only. Wound size and HRQoL were measured at baseline, end of the intervention period (week 4), and week 12. At baseline, wound sizes were similar for both the intervention and control groups. During the intervention period, there was no significant difference in wound sizes between groups (intervention group: median (cm²) = 2.4, IQR = 1.3-12.7; control group: median (cm²) = 5.0, IQR = 2.5-9.9; P = .05). Mean HRQoL scores for all subscales at baseline and weeks 4 and 12 were similar between groups except for Wellbeing, which was significantly higher in the intervention group at the end of the 4-week intervention period (intervention group: mean = 52.41, SD = 24.50; control group: mean = 38.15, SD = 21.25; P = .03; d = 0.62). The trial findings suggest that daily applications of EMLA as a primary dressing do not inhibit wound healing and may improve patient well-being. Studies with larger samples are required to more comprehensively evaluate the impact of this treatment on wound healing and HRQoL.
Article
Background: Venous leg ulcers are a type of chronic, recurring, complex wound that is more common in people aged over 65 years. Venous ulcers pose a significant burden to patients and healthcare systems. While compression therapy (such as bandages or stockings) is an effective first-line treatment, ultrasound may have a role to play in healing venous ulcers. Objectives: To determine whether venous leg ulcers treated with ultrasound heal more quickly than those not treated with ultrasound. Search methods: We searched the Cochrane Wounds Specialised Register (searched 19 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations, MEDLINE Daily and Epub Ahead of Print) (1946 to 19 September 2016); Ovid Embase (1974 to 19 September 2016); and EBSCO CINAHL Plus (1937 to 19 September 2016). We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting. Selection criteria: Randomised controlled trials (RCTs) that compared ultrasound with no ultrasound. Eligible non-ultrasound comparator treatments included usual care, sham ultrasound and alternative leg ulcer treatments. Data collection and analysis: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We attempted to contact trial authors for missing data. Main results: Eleven trials are included in this update; 10 of these we judged to be at an unclear or high risk of bias. The trials were clinically heterogeneous with differences in duration of follow-up, and ultrasound regimens. Nine trials evaluated high frequency ultrasound; seven studies provided data for ulcers healed and two provided data on change in ulcer size only. Two trials evaluated low frequency ultrasound and both reported ulcers healed data.It is uncertain whether high frequency ultrasound affects the proportion of ulcers healed compared with no ultrasound at any of the time points evaluated: at seven to eight weeks (RR 1.21, 95% CI 0.86 to 1.71; 6 trials, 678 participants; low quality evidence - downgraded once for risk of bias and once for imprecision); at 12 weeks (RR 1.26, 95% CI 0.92 to 1.73; 3 trials, 489 participants; moderate quality evidence - downgraded once for imprecision); and at 12 months (RR 0.93, 95% CI 0.73 to 1.18; 1 trial, 337 participants; low quality evidence - downgraded once for unclear risk of bias and once for imprecision).One trial (92 participants) reported that a greater percentage reduction in ulcer area was achieved at four weeks with high-frequency ultrasound, while another (73 participants) reported no clear difference in change in ulcer size at seven weeks. We downgraded the level of this evidence to very low, mainly for risk of bias (typically lack of blinded outcome assessment and attrition) and imprecision.Data from one trial (337 participants) suggest that high frequency ultrasound may increase the risk of non-serious adverse events (RR 1.29, 95% CI 1.02 to 1.64; moderate quality evidence - downgraded once for imprecision) and serious adverse events (RR 1.21, 95% CI 0.78 to 1.89; moderate quality evidence downgraded once for imprecision).It is uncertain whether low frequency ultrasound affects venous ulcer healing at eight and 12 weeks (RR 3.91, 95% CI 0.47 to 32.85; 2 trials, 61 participants; very low quality evidence (downgraded for risk of bias and imprecision)).High-frequency ultrasound probably makes little or no difference to quality of life (moderate quality evidence, downgraded for imprecision). The outcomes of adverse effects, quality of life and cost were not reported for low-frequency ultrasound treatment. Authors' conclusions: It is uncertain whether therapeutic ultrasound (either high or low frequency) improves the healing of venous leg ulcers. We rated most of the evidence as low or very low quality due to risk of bias and imprecision.
Chapter
Diagnose und Therapie der TVT umfassen einen sehr schwierigen Teil in der Arbeit des Gefäßmediziners. Die Gefahr von Fehleinschätzungen und Fehlentscheidungen ist auch für den Erfahrenen stets gegenwärtig.
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Objective/background: Mechanochemical endovenous ablation (MOCA) has been developed as a tumescentless technique to ablate saphenous veins and to avoid heat induced complications and post-procedural pain. The mechanism of action of MOCA is poorly understood. The present experiments were conducted to determine the effect of MOCA on vein wall injury and sclerosis in an animal model. Methods: A total of 36 lateral saphenous veins (LSVs) were treated in 18 goats according to the human protocol. Veins from nine goats were evaluated 45 min after the procedure, while in the remaining nine, the treated veins were evaluated 6 weeks later. All treated veins were divided equally over three treatment groups: (i) MOCA, (ii) mechanical ablation without the sclerosant, and (iii) liquid sclerotherapy alone. The histological effects of treatment on the vein wall were systematically evaluated. Results: The average diameter of the LSV was 4.0 ± 0.5 mm. Technical success was achieved in all but one LSV (35/36; 97%), with a median procedure time of 14 min (range 9-22 min). In the acute group, histological examination showed that mechanical ablation (alone or MOCA) induced severe injury to the endothelium in 82% but no damage to other layers of the vein wall. Mechanical ablation led to vasoconstriction. After 6 weeks follow-up, four of six MOCA treated veins were occluded. The occluded segments consisted mainly of fibrotic lesions probably evolved from organised thrombus. No occlusions were observed after sclerotherapy or mechanical treatment alone. No major complications occurred during procedures or follow-up. Conclusion: MOCA is associated with an increased occlusion rate compared with its separated components of mechanical ablation or sclerotherapy. The occlusion consists of cellular fibrotic material likely to be evolved from organised thrombus with fibrotic alterations to the surrounding media and adventitia. This study underlines the hypothesis that the additive use of MOCA increases the effectiveness of sclerosants alone by inducing endothelial damage and probably vasoconstriction.
Article
Objective: Chronic deep venous obstruction can cause a significant loss of quality of life, although it can be treated successfully by stenting. A clear referral pattern for additional imaging is warranted in patients with lower limb complaints. The aim of this study was to determine the value of clinically visible abdominal wall collateral veins in the diagnosis of a potentially treatable deep venous obstruction. Methods: A total of 295 patients referred for evaluation at a tertiary venous clinic with a collateral vein on the abdominal wall or pubic bone, visible on physical examination, were retrospectively analyzed and compared with a randomly selected control group of 365 patients without such a collateral vein. Duplex ultrasound, magnetic resonance venography, computed tomography venography, and conventional venography were used to determine the presence or absence of deep venous obstruction. Results: Mean age of the group with a positive collateral was 43.5 ± 13.7 (6-76) years compared with 44.7 ± 14.2 (16-89) years in the control group. In the collateral group, 66.1% were female compared with 63.3% in the control group. Sensitivity of the abdominal wall collateral vein for any obstruction at the level of the groin or more proximal was 53% (95% confidence interval [CI], 48-57); specificity, 86% (95% CI, 79-91); positive predictive value, 93% (95% CI, 90-96); and negative predictive value, 32% (95% CI, 28-37). Sensitivity was 68% (95% CI, 62-73) for higher degrees of post-thrombotic obstruction and 27% (95% CI, 19-36) in iliac vein compression. Conclusions: A collateral vein on the abdominal wall or across the pubic bone in patients with complaints of the lower limb has an excellent positive predictive value for deep venous obstructive disease at the level of the groin or higher. Such collateral veins should therefore not be removed, and symptomatic patients could be offered further diagnostics and treatment.
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To examine the effectiveness and cost-effectiveness of antimicrobial silver-donating dressings for venous leg ulcers compared with simple non-adherent (also known as low-adherent) dressings. A pragmatic, prospective randomised controlled trial (RCT) and cost-effectiveness analysis of silver-donating versus low-adherent dressings in the treatment of venous leg ulcers. A non-randomised observational group was also recruited. Primary and secondary care services in the north and south of England (Sheffield and Exeter). Consenting patients with active ulceration of the lower leg that had been present for a period of greater than 6 weeks. Patients were randomised to receive either a silver-donating or non-silver low-adherent dressing applied beneath compression bandages or hosiery. The choice of dressing within these groups was left to clinician preference. Evaluation was by clinical assessment, supplemented by evaluation of quality of life and cost-effectiveness. The primary outcome measure was complete ulcer healing at 12 weeks in the index limb. Secondary measures were costs and quality-adjusted life-years (QALYs), cost-effectiveness, time to healing, and recurrence rate at 6 months and 1 year. In total, 304 participants were recruited to the clinical trial: 213 to the RCT and 91 to the observational arm. Within the RCT 107 were randomised to antimicrobial dressings and 106 to the control dressings. There were no significant differences (p > 0.05) between the two groups for the primary outcome measure of proportion of ulcers healed at 12 weeks (59.6% for silver and 56.7% for control dressings). The overall median time to healing was also not significantly different between the two groups (p = 0.408). A total of 24 patients had recurrent ulcers within 1 year; the recurrence rates of 11.6% (n = 11) for the antimicrobial and 14.4% (n = 13) for the control dressings were not significant. Mean utility valuations for both the EuroQol 5 dimensions (EQ-5D) quality of life questionnaire and Short Form 6 dimensions (SF-6D) utility index showed no differences for either group at 1, 3, 6 or 12 months. Compared with the control group, the antimicrobial group had an incremental cost of 97.85 pounds and an incremental QALY gain of 0.0002, giving an incremental cost-effectiveness ratio for the antimicrobial dressings of 489,250 pounds. Cost-effectiveness modelling of the results of the RCT showed that antimicrobial dressings were not cost-effective. No significant differences in either primary or secondary end points were found between the use of antimicrobial silver-donating dressings and the control group of low-adherent dressings. Modelling showed that antimicrobial silver dressings were not cost-effective. Current Controlled Trials ISRCTN72485131.
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To test the acceptability, validity, and reliability of the short form 36 health survey questionnaire (SF-36) and to compare it with the Nottingham health profile. Postal survey using a questionnaire booklet together with a letter from the general practitioner. Non-respondents received two reminders at two week intervals. The SF-36 questionnaire was retested on a subsample of respondents two weeks after the first mailing. Two general practices in Sheffield. 1980 patients aged 16-74 years randomly selected from the two practice lists. Scores for each health dimension on the SF-36 questionnaire and the Nottingham health profile. Response to questions on recent use of health services and sociodemographic characteristics. The response rate for the SF-36 questionnaire was high (83%) and the rate of completion for each dimension was over 95%. Considerable evidence was found for the reliability of the SF-36 (Cronbach's alpha greater than 0.85, reliability coefficient greater than 0.75 for all dimensions except social functioning) and for construct validity in terms of distinguishing between groups with expected health differences. The SF-36 was able to detect low levels of ill health in patients who had scored 0 (good health) on the Nottingham health profile. The SF-36 is a promising new instrument for measuring health perception in a general population. It is easy to use, acceptable to patients, and fulfils stringent criteria of reliability and validity. Its use in other contexts and with different disease groups requires further research.
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A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.
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The Medical Outcomes Study was designed to (1) determine whether variations in patient outcomes are explained by differences in system of care, clinician specialty, and clinicians' technical and interpersonal styles and (2) develop more practical tools for the routine monitoring of patient outcomes in medical practice. Outcomes included clinical end points; physical, social, and role functioning in everyday living; patients' perceptions of their general health and well-being; and satisfaction with treatment. Populations of clinicians (n = 523) were randomly sampled from different health care settings in Boston, Mass; Chicago, Ill; and Los Angeles, Calif. In the cross-sectional study, adult patients (n = 22,462) evaluated their health status and treatment. A sample of these patients (n = 2349) with diabetes, hypertension, coronary heart disease, and/or depression were selected for the longitudinal study. Their hospitalizations and other treatments were monitored and they periodically reported outcomes of care. At the beginning and end of the longitudinal study, Medical Outcomes Study staff performed physical examinations and laboratory tests. Results will be reported serially, primarily in The Journal.
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To assess the validity, reliability, and acceptability of the short form 36 (SF 36) health survey questionnaire (a shortened version of a battery of 149 health status questions) as a measure of patient outcome in a broad sample of patients suffering from four common clinical conditions. Postal questionnaire, followed up by two reminders at two week intervals. Clinics and four training practices in north east Scotland. Over 1700 patients aged 16-86 with one of four conditions--low back pain, menorrhagia, suspected peptic ulcer, or varicose veins--and a comparison sample of 900 members of the general population. The eight scales within the SF36 health profile. The response rate exceeded 75% in the patient population (1310 respondents). The SF36 satisfied rigorous psychometric criteria for validity and internal consistency. Clinical validity was shown by the distinctive profiles generated for each condition, each of which differed from that in the general population in a predictable manner. Furthermore, SF36 scores were lower in referred patients than in patients not referred and were closely related to general practitioners' perceptions of severity. These results provide support for the SF36 as a potential measure of patient outcome within the NHS. The SF36 seems acceptable to patients, internally consistent, and a valid measure of the health status of a wide range of patients. Before it can be used in the new health service, however, its sensitivity to changes in health status over time must also be tested.
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To develop a valid and reliable outcome measure for patients with varicose veins. Postal questionnaire survey of patients with varicose veins. Surgical outpatient departments and training general practices in Grampian region. 373 patients, 287 of whom had just been referred to hospital for their varicose veins and 86 who had just consulted a general practitioner for this condition and, for comparison, a random sample of 900 members of the general population. Content validity, internal consistency, and criterion validity. 281(76%) patients (mean age 45.8; 76% female) and 542(60%) of the general population (mean age 47.9; 54% female) responded. The questionnaire had good internal consistency as measured by item-total correlations. Factor analysis identified four important health factors: pain and dysfunction, cosmetic appearance, extent of varicosity and complications. The validity of the questionnaire was demonstrated by a high correlation with the SF-36 health profile, which is a general measure of patients' health. The perceived health of patients with varicose veins, as measured by the SF-36, was significantly lower than that of the sample of the general population adjusted for age and a lower proportion of women. A clinically derived questionnaire can provide a valid and reliable tool to assess the perceived health of patients with varicose veins. The questionnaire may be used to justify surgical treatment of varicose veins.
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Chronic venous insufficiency (CVI) is a very variable and complex entity that has stimulated different attempts at classification. Several proposals have been made in recent years, based on objective and anatomical criteria, most of them incomplete and unsatisfactory. Finally the CEAP classification was presented in 1994. This certainly is the most nearly complete classification, since it takes into consideration not only the main aspects of CVI: Clinical, Etiological, Anatomical, and Pathophysiological, but also the degrees of severity, reported in the form of scores. It is now accepted internationally although it still has some flaws (such as the absence of the corona phlebectactica sign) and inaccuracies (above all in the clinical part and the scoring). Recently, some members of the Promoting Committee proposed a substantial modification of the part on scores, coming closest to the clinical reality, instrumental diagnosis, and current therapies. The characteristics of CEAP enable us to affirm that this represents the most original and useful classification, not only for clinical studies, but also in the assessment of therapeutic results and in patient follow-up. Like all classifications, CEAP also needs to be validated by means of clinical studies in order to demonstrate its applicability. For this purpose, a European Working Group was set up in 1997, The first interesting results of 872 dossiers collected by means of a computerized program (European Phlebological File) were presented at several international congresses and concentrated on the consistency and reproducibility of the clinical part of the CEAP classification in different clinical settings.
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Application of generic and specific measures of health status and quality of life to different diseases, conditions, states, and populations is increasing. Four strategies for using these measures are separate generic and specific measures, modified generic measures, disease-specific supplements, and batteries. The preferred strategy depends on project aims, methodological concerns, and practical constraints. Generic measures are necessary to compare outcomes across different populations and interventions, particularly for cost-effectiveness studies. Disease-specific measures assess the special states and concerns of diagnostic groups. Specific measures may be more sensitive for the detection and quantification of small changes that are important to clinicians or patients. Comparison studies are needed of the validity, reliability, and responsiveness of generic and disease-specific measures in the same population and in minority and age-specific groups.
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