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Modelling the effect of venous disease on quality of life
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.
... [9][10][11] It has also been frequently used in CVI as well. 3,12,13 ...
... 4 The HRQoL in the clinically worst category of CVI (C6) patients was comparable to those with chronic congestive cardiac failure and chronic lung failure. 3 Venous disease used to be perceived as an aesthetic problem affecting primarily on appearance, self-esteem, and emotional health. These findings have eliminated any doubts about the worsen effects of venous disease on the functional aspects of quality of life than the emotional components as the disease advances. ...
... This is what was found in other studies as well. 3,19 This would suggest that not all symptomatic CVI patients would benefit the same way regardless of their presentation. This important massage need to be clearly imparted, especially to primary care team that would be the first point of contact. ...
INTRODUCTION: Chronic venous insufficiency (CVI) is a common condition especially among those of advance age that is often neglected. As the disease severity progresses, it increases the healthcare cost and resources required, while diminishing the quality of life of the persons. Health-related Quality of Life (HRQoL) among CVI patients begins to decline once the symptom starts to appear, and reduces it further as the symptoms worsens. MATERIALS AND METHODS: This is a prospective, multi-centred, cross-sectional study on consenting symptomatic CVI patients who presented to the International Islamic University of Malaysia (IIUM) teaching hospital in Pahang, Malaysia. The diagnosis of CVI was confirmed on duplex imaging. Clinical grading was performed using Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification. Patients completed generic validated Malay language Short Form 36 (SF36) HRQoL instrument. RESULTS: One hundred and ten patients (62% male) with a mean age of 57 years, Malays (60%), Chinese (25%) and Indian (15%) were recruited. The most frequent CVD symptoms reported were pain (42%). The clinical, aetiological, anatomical, and pathophysiological (CEAP) classification placed most patients in the C2 class (34%). Apart from partaking in social functions, all other elements of mental and physical health component of SF 36 showed a marked deterioration as the disease progressed. CONCLUSIONS: We found a significant decline in the HRQoL among symptomatic CVI patients presenting to IIUM hospital in a multi-ethnic developing country.
... Prolonged CVI can lead to permanent lymphoedema (1). CVI has even in uncomplicated disease been shown to have a significant negative impact on QoL (22). An increased incidence of depression has been seen in patients with CVI (23). ...
... An increased incidence of depression has been seen in patients with CVI (23). In the most-severe forms with venous ulceration, patients with CVI report significant pain scores and QoL impairment comparable to that seen in patients with chronic obstructive pulmonary disease or heart failure (22,24). ...
... The disease has been proven to be under-estimated by health-care professionals (85). The QoL values of patients most-severely affected by CVD (C6) have been reported to be comparable of those of patients with congestive heart failure and chronic lung disease (22). Even patients with uncomplicated disease (C2) have reported reduced QoL (22,86). ...
Chronic venous incompetence (CVI) is a common condition, and varicose vein treatment is one of the most-common surgical procedures performed worldwide. Common symptoms of CVI are pain, cramps, itching, feeling of leg heaviness and venous claudication. Advanced CVI can lead to skin changes, eczema and venous ulcers. While the cause of the disease is un-known, it often starts with venous enlargement and valve dysfunction. The overall aims of this thesis are: 1) to develop quantitative diagnostic measurements using strain-gauge plethysmography (SGP) with standardised superficial venous occlusion and duplex ultrasound (DUS); 2) to evaluate the effects of radiofrequency ablation (RFA) and high ligation/stripping (HL/S) for patients with great saphenous vein (GSV) incompetence; and 3) to evaluate the cost-effectiveness of GSV treatment.
The first of the four studies involved patients with GSV incompetence. For these patients, SGP with superficial venous occlusion was performed before and after GSV treatment. SGP was able to predict the haemodynamic outcome of the treatment in the majority of the limbs examined. The conclusion is that SGP with standardised superficial venous occlusion may be used for predicting the outcome of GSV treatment.
The second study evaluated the short-term outcomes of GSV treatment using RFA and HL/S regarding haemodynamics and quality of life (QoL). Both treatments lead to significant improvements in QoL, with no signifcant differences between the treatments. Despite successful treatment, the majority of the limbs in both treatment groups had significant residual reflux located mainly in the calf (i.e., below the treated area). The residual reflux may be a risk factor for future symptom relapses and need to be examined in more-long-term studies.
The third study examined quantitative DUS and SGP parameters in relation to clinical severity and QoL. DUS-derived volume flow and SGP re-flux time showed weak but significant correlations with clinical severity (C in CEAP). The conclusion is that the current gold standard using the qualitative DUS-derived reflux time for CVI diagnostics should be revised and replaced with a more-relevant quantitative parameter.
The fourth study evaluated the cost-effectiveness of GSV treatment with 1 year of follow-up. Both RFA and HL/S provided significant improvements in QoL. RFA is very cost-effective and is associated with fewer days missed from work compared to HL/S. Cost-wise, both methods are well be-low the national threshold for cost-effective treatment. Due to its higher cost, HL/S should be reserved for cases that require this method.
... Individuals with more severe disease had a reduction in plantar flexion ROM compared to individuals with lower clinical severity, in agreement with the findings of Carradice et al. (2011) 23 and Moura et al. (2012). 13 However, the dorsiflexion ROM, the level of physical activity measured by the HAP, and the triceps sural function measured by the HRT did not differ between the two groups. ...
... Individuals with more severe disease had a reduction in plantar flexion ROM compared to individuals with lower clinical severity, in agreement with the findings of Carradice et al. (2011) 23 and Moura et al. (2012). 13 However, the dorsiflexion ROM, the level of physical activity measured by the HAP, and the triceps sural function measured by the HRT did not differ between the two groups. ...
... These findings may suggest that individuals' functional capacity does not only depend on the clinical severity of the disease, in accordance with the biopsychosocial health model, in which the concepts "health-disease" go from the logic of linearity to relational logic. 23 The characteristics found in this sample are consistent with other studies 4 , 5 , 13 that also found in individuals with CVI alterations in the structure and function of the musculoskeletal system, in addition to limitations in carrying out activities and restriction in social participation. The present study contributes to the under- HRT, heel-rise test; BMI, body mass index; AAS, adjusted activity score; * p < 0.05 Table 3 Comparative analysis between groups stratified by the presence or absence of mobility impairment (n = 99). ...
Objectives:
Describe and analyze the sociodemographic, clinical and functional characteristics of individuals with chronic venous insufficiency (CVI) and compare the clinical severity with levels of mobility.
Methods:
Exploratory cross-sectional study in a single public health center. The study cohort comprised 99 individuals.
Interventions:
Clinical, sociodemographic and physical activity level questionnaires were applied; we also evaluated ankle amplitude and sural triceps function. Descriptive statistics, independent t test and one-way ANOVA with post hoc Least Significant Difference (LSD) were performed.
Results:
Ninety-nine participants (87.9% woman) with an average age with an average age of 60.6 ± 14 years who where recruited to the study. The cohort was composed of individuals were moderately active, 80% exhibited symptoms of the disease and approximately 40% reported reduced mobility. Individuals who had reduced mobility and less physical activity showed reduced ankle amplitude and muscle function (p <0.05).
Conclusion:
CVI impacts on functional capacity, even in individuals with less severe disease.
... 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]. ...
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.
... [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. ...
Background Chronic venous disease can be defined as any long-term morphological or functional abnormality of the venous system manifested by symptoms or signs indicating the need for care. There are limited 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. Methods We retrospectively reviewed cases of radiofrequency ablation and laser ablation for venous insufficiency between February 2016 and December 2020. Patients were selected based on symptoms; the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification system; and duplex ultrasonographic findings of reflux at the saphenopopliteal junction and saphenofemoral junction. Most procedures were day cases performed under spinal anaesthesia. Results There were 139 patients who underwent treatment. Of these, 27% were men, and 73% were women. The majority of patients, 54%, were classified as CEAP C3, with CEAP C5 accounting for the smallest proportion at 7%. Most patients (89%) underwent successful bilateral greater saphenous vein thermal ablation, and 53% underwent bilateral greater and lesser saphenous vein thermal ablation. Conclusions Venous ablation therapy is a safe, efficacious, day procedure associated with rapid recovery.
... Венозные язвы нижних конечностей склонны к инфекции, может наблюдаться местный целлюлит, усиление боли, увеличение количества экссудата, лихорадка, неприятный запах и отек. Продолжительная боль и недостаток сна могут приводить к ощущениям подавленности и депрессии [22,23]. ...
The article provides a review of the literature on the role of compression knitwear in the complex treatment of chronic venous disease (CVD). The pathogenesis of CVD and its complications is analyzed, with the consequent need to follow a precisely calibrated pressure profile (graduated compression) when choosing compression knitwear. Based on the literature data, it has been shown that it is precisely a strictly selected pressure gradient that guarantees the flow of blood to the heart, and not in the opposite direction or the distribution of blood through the superficial veins. Correct graduated compression reduces venous hypertension, improves the functioning of the musculoskeletal pump, facilitates venous return and improves lymphatic drainage, exerting positive physiological and biochemical effects affecting the venous, arterial and lymphatic systems. It is necessary to take into account the fact that patients with a pronounced violation of venous outflow have increased skin sensitivity, a tendency to atopic reactions, irritations and various discomfort when wearing compression knitwear. This often leads to its irregular use, which increases the duration of treatment. Thus, the effectiveness of compression therapy can only be ensured by high-quality compression knitwear, confirmed by clinical studies, having international certificates of conformity and a wide range of sizes, allowing to select compression knitwear for each patient individually. An impressive evidence base is provided, including both international clinical trials and domestic observations, attesting to the compliance of mediven® elegance compression knitwear with RAL-387 quality standards. CVD and flat feet are related conditions. With flat feet, the muscles of the lower leg suffer greatly, which are forced to be under increased stress while working with increased stress. It is their work that ensures the normal outflow of venous blood. To reduce the risk of developing CVD with flat feet, it is recommended to use orthopedic insoles in combination with compression knitwear, which reduces the load on the legs and helps slow down the development of varicose veins. The combined use of orthopedic insoles and compression knitwear will reduce pain, swelling and heaviness in the legs, create comfort, increase confidence when walking, ensure proper foot position due to their design, improve the functioning of the shin muscles and, as a result, venous outflow.
... 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 ...
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.
... As previously described patients' postoperative satisfaction and quality of life were also investigated in this study since both parameters have a major influence of the severity of venous disease and the associated treatment success in the first place. 19 A markedly high level of satisfaction was observed in every area studied (Figure 2). In a study published by Gerontopoulou et al. in 2018, in which 83 patients also received modified Junod crossectomy, with a median follow-up time of 16.2 months, a high level of patient satisfaction was documented as well. ...
... В соответствии с обобщенными эпидемиологическими данными распространенность ХЗВ в популяции достигает 67,5%, среди которых на неосложненную варикозную болезнь нижних конечностей (ВБНК; клинический класс C2 по классификации CEAP) приходится до 19% [4]. ХЗВ существенным образом ухудшают качество жизни пациента не только в сфере физического самочувствия и эстетического благополучия, но также оказывают негативное влияние на эмоциональное состояние и социальное взаимодействие [5,6]. По некоторым данным, качество жизни больных с венозными трофическими язвами может соответствовать уровню хронической сердечной недостаточности, и до 54% из них теряют трудоспособность [3,7]. ...
Chronic venous disease (CVD), which includes varicose veins (VVs) of the lower limbs, is one of the most common and socially significant cardiovascular diseases. Despite the recognition of elastic compression as an essential method of CVD treatment, the benefits and feasibility of its usage during the perioperative period are being reconsidered. This narrative literature review aims to highlight the current evidence of the efficacy of elastic compression in relieving initial and residual vein-specific symptoms, reducing the risk of adverse events and VVs recurrence after surgical treatment. It also provides brief information about the mechanisms of action of compression therapy and discusses compliance issues. Nowadays, the concept of the influence of elastic compression on the diameter of veins and venous outflow velocity has been critically revised. It has been shown that deep veins are more sensitive to external compression, while it is impossible to reduce the caliber of superficial veins under the usual pressure. Extensive evidence indicates the efficacy of compression therapy in relieving venous symptoms, which may persist in 30—40% of patients after surgery. The usage of compression therapy perioperatively helps reduce the rate and severity of such adverse events as pain, bruising, and hyperpigmentation, as well as promotes the resorption of veins after sclerotherapy. However, the optimal mode and duration of compression have not been finally determined. Despite the presence of individual studies, the effect of compression therapy on the progression of CVD and the risk of VVs recurrence has not been proven. The main disadvantage of elastic compression is relatively low compliance, which varies between 26 and 74%. To improve it, both motivational conversations by the doctor and efforts by manufacturers to maintain maximal product quality while giving them optimal properties for comfortable wear are essential. Thus, compression therapy is still an important component of the perioperative treatment of VVs of the lower limb.
... Approximately 25% of adults in the United States are affected by chronic venous disease, which leads to a significant decrease in quality of life (QOL) and associated disease burden, as well as a loss of work productivity [27,28]. In a study conducted by YıldızŞahin and Karaman Özlü (2021) [29] on 312 patients, the mean quality of life associated with the venous insufficiency score of the patients was 74.95 ± 12.86, which was considered moderate. ...
Background and Objectives: Chronic venous insufficiency negatively affects the quality of life and reduces the job performance of nurses, who are important components of the healthcare system. The aim of this study was to assess the risk factors of venous insufficiency according to demographic characteristics among nurses working at a foundation university hospital. Materials and Methods: This study used an analytical cross-sectional approach. The sample consisted of 100 nurses working at a foundation university hospital in a metropolitan city of Turkey. Data were collected using a demographic characteristics form, VEINESQOL/Sym, and a CEAP classification form. The condition of varicose veins among the nurses was diagnosed by a cardiovascular surgeon using Doppler ultrasonography. Results: The prevalence of chronic venous insufficiency (CVI) among nurses was 65%, with 48% at a C1 level according to the CEAP classification. CVI was higher among those with chronic diseases (p = 0.027) and those who had pregnancy (p = 0.021). In addition, the risk of CVI (+) was 7.68 times higher among those aged older than 26.5 years and 36.14 times higher for women (p < 0.001). A 0.9-fold increase in the risk of CVI (+) among nurses produced a one-unit decrease in venous-insufficiency-related quality of life (p = 0.006, OR = 0.94, 95% CI:(0.896–0.982)). Conclusions: The prevalence of CVI among nurses was found to be high, especially among women, those with chronic diseases, and pregnant individuals. In this context, it is recommended to implement risk screening and prevention education programs for CVI among nurses.
... Varicose veins and their complications are among the most common conditions limiting quality of life (QoL) [1][2][3][4][5] , with a reported prevalence of 30-40% among adults and an incidence rate of 39-52 per 1000 person-years [6][7][8][9][10] . An estimated 35 000 varicose vein procedures are carried out in the National Health Service per year in England 11 , and this is projected to rise with increasing population size, age, and BMI. ...
Background
Surgical ligation and stripping (surgery) and endothermal ablation are both effective treatments for varicose veins, improving quality of life (QoL) up to 5 years. Few data are available on long-term outcomes. The aim of this study was to evaluate the outcomes 10 years after interventions in an RCT. Previously this RCT demonstrated that endothermal ablation is associated with superior postprocedural QoL, more rapid recovery, and lower rates of early clinical recurrence. This analysis reports outcomes at 10 years.
Methods
Patients with symptomatic varicose veins owing to unilateral great saphenous vein reflux were randomized to either surgery or endovenous laser ablation (EVLA). Outcomes at 10 years included clinical recurrence and QoL.
Results
Data were obtained for 206 of 280 patients (73.6%) at 10 years. Both groups retained significant QoL improvement compared with pretreatment levels (Aberdeen Varicose Vein Questionnaire (AVVQ), Short Form 36 (SF-36®), and EQ-5D™; P < 0.001). Clinical disease progression from baseline was observed in only 10.7% of patients. The clinical recurrence rate was lower in the EVLA group (37 versus 59%; P = 0.005). The number needed to treat with EVLA to avoid one clinical recurrence within 10 years was five. This was associated with significantly higher (better) generic QoL scores with EVLA in several SF-36® domains, including bodily pain (median 84 (i.q.r. 51–100) versus 62 (41–84); P = 0.009) and general health (77 (62–87) versus 67 (52–82); P = 0.017). AVVQ scores in the EVLA group were also lower (better) (3.1 (0–7.7) versus 6.3 (0.7–13.3); P = 0.029).
Conclusion
Both surgery and endothermal ablation are effective treatments for varicose veins at 10 years, with durable improvement in QoL and a very low rate of disease progression. However, endothermal ablation was associated with superior clinical and QoL outcomes. Registration number: NCT00759434 (http://www.clinicaltrials.gov).
... The prevalence of superficial vein reflux is 21% in the adult population, which increases linearly Open access with age. 1 CVI has been associated with decreased general and disease-specific quality of life (QoL). [2][3][4] CVI is generally caused by insufficiency of the great saphenous vein (GSV). 5 Minimally invasive endothermal treatment, for example, endovenous laser ablation (EVLA) or radiofrequency ablation (RFA), has become the first line of treatment for superficial venous reflux. This treatment strategy has the advantage of avoiding general anaesthesia, shortening operation time and decreasing postoperative pain and morbidity when compared with open surgery. ...
Introduction
Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is associated with a risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation (NTA) alternative, which combines mechanical endothelial damage with the infusion of a sclerosant liquid or foam. Tumescent anaesthesia is not required. Preliminary experiences with MOCA using the Clarivein device show less intraprocedural and postprocedural pain and a faster clinical improvement compared with EVLA. Flebogrif (Balton, Poland) is a relatively new MOCA device. To determine the role of MOCA using Flebogrif, a well-designed, randomised controlled clinical trial of sufficient sample size and follow-up time is required. In this article, we provide the study protocol for the REBORN trial, aiming to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the outcome of anatomical success in the treatment of GSV incompetence.
Methods and analysis
This multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial randomises patients who are diagnosed with GSV incompetence and aged 18–80 years between Flebogrif and EVLA. 310 patients in 3 participating centres (Northwest Clinics Alkmaar, Skin and Vein Clinic Oosterwal Alkmaar and Red Cross Hospital Beverwijk) will be included. The primary outcome is anatomical success at 12 months. Secondary outcomes are intraprocedural pain, operation time, technical success, postprocedural pain, safety, anatomical success during other follow-up moments, complications, clinical success, aesthetic result, disease-specific quality of life, reinterventions, anterior accessory saphenous vein reflux and neovascularisation. Patients will be followed up at 1 week, 1, 6, 12, 24 and 60 month(s) after treatment.
Ethics and dissemination
The institutional review board (Medical Ethical Review Committee of the Vrije Universiteit Medical Center) approved this study on 17 May 2021 under case number 2020.0740. Written informed consent is obtained by the coordinating investigator from all participants prior to study enrolment. After completion of the trial, the results will be submitted to an international scientific journal for peer-reviewed publication.
Trial registration number
Overzicht van Medisch-wetenschappelijk Onderzoek in Nederland, NL-OMON25145, previously NL9527; Centrale Commissie Mensgebonden Onderzoek, NL74491.029.20.
... Superficial venous insufficiency (SVI) is a common condition, with presentations ranging from aesthetic concerns to significant morbidity and debility of quality of life. [1][2][3] Varicose veins can be an early indicator of SVI in 30% to 50% of adults. Advanced venous disease manifests as lower extremity edema and discomfort in 20% to 50%, skin trophic changes in 3% to 5%, and ulceration in w1% of the adult population. ...
Objective
Endovenous ablation is the standard of care for patients with symptomatic superficial venous insufficiency. For patients with a history of deep vein thrombosis (DVT), concern exists for an increased risk of postprocedural complications, particularly venous thromboembolism. The objective of this study was to evaluate the safety and efficacy of endovenous thermal ablation in patients with a history of DVT.
Methods
The national Vascular Quality Initiative Varicose Vein Registry was queried for superficial venous procedures performed from January 2014 to July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety end point was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3 months of follow-up. The secondary safety end points included any proximal thrombus extension (ie, EHIT I-IV), major bleeding, hematoma, pulmonary embolism, and death due to the procedure. The primary efficacy end point was technical failure (ie, recanalization at <1 week of follow-up). Secondary efficacy end points included the risk of recanalization over time and the postprocedural change in quality-of-life measures. Outcomes stratified by preoperative use of anticoagulation (AC) were also compared among those with prior DVT.
Results
Among 33,892 endovenous thermal ablations performed on 23,572 individual patients aged 13 to 90 years, 1698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (P < .001), had a higher body mass index (P < .001), were more likely to be male at birth (P < .001) and Black/African American (P < .001), and had greater CEAP classifications (P < .001). A history of DVT conferred a higher risk of new DVT (1.4% vs 0.8%; P = .03), proximal thrombus extension (2.3% vs 1.6%; P = .045), and bleeding (0.2% vs 0.04%; P = .03). EHIT II-IV, pulmonary embolism, and hematoma risk did not differ by DVT history (P = NS). No deaths from treatment occurred in either group. Continuing preoperative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (P = NS) but did confer an increased hematoma risk among all endovenous thermal ablations and surgeries (P = .001). Technical failure was similar between groups (2.0% vs 1.2%; P = .07), although a history of DVT conferred an increased recanalization risk over time (hazard ratio, 1.90; 95% confidence interval, 1.46, 2.46; P < .001). The groups had comparable improvements in postprocedural venous clinical severity scores and Heaviness, Aching, Swelling, Throbbing, and Itching scores (P = NS).
Conclusions
Endovenous thermal ablation for patients with a history of DVT was effective. However, appropriate patient counseling regarding a heightened DVT risk, albeit still low, is critical. The decision to continue or withhold AC preoperatively should be tailored on a case-by-case basis.
... [2][3][4][5] Chronic venous disease has a well-documented association with deterioration in quality of life. [6][7][8] Historically, SVI was managed surgically with high ligation at the saphenofemoral junction with or without stripping of the great saphenous vein. Less commonly, treatment of small saphenous vein reflux is warranted with ligation at the saphenopopliteal junction. ...
Objective
The necessary training and certification of providers performing venous ablation has become a topic of debate in recent years. As venous interventions have shifted away from the hospital, the diversity of provider backgrounds has increased. We aimed to characterize superficial venous ablation practice patterns associated with different provider types.
Methods
We analyzed Medicare Fee-For-Service data from 2010 through 2018. Procedures were identified by their Current Procedural Terminology code and included radiofrequency ablation, endovenous laser ablation, chemical adhesive ablation (ie, VenaSeal; Medtronic, Inc), and mechanochemical ablation. These procedures were correlated with the practitioner type to identify provider-specific trends.
Results
Between 2010 and 2018, the number of ablation procedures increased by 107% from 114,197 to 236,558 per year (P < .001). Most procedures were performed by surgeons without vascular board certification (28.7%; 95% confidence interval [CI], 28.7%-28.8%), followed by vascular surgeons (27.1%; 95% CI, 27.0%-27.2%). Traditionally noninterventional specialties, which exclude surgeons, cardiologists, and interventional radiologists, accounted for 14.1% (95% CI, 14.1%-14.2%), and APPs accounted for 3.5% (95% CI, 3.4%-3.5%) of all ablation procedures during the study period. The total number of ablations increased by 9.7% annually (95% CI, 9.7%-9.8%), whereas procedures performed by APPs increased by 62.0% annually (95% CI, 61.6%-62.4%). There were significant differences between specialties in the use of nonthermal ablation modalities: APPs had the highest affinity for nonthermal ablation (odds ratio [OR], 2.60; 95% CI, 2.51-2.69). Cardiologists were also more likely to use nonthermal ablation (OR, 1.62; 95% CI, 1.59-1.66). Similarly, the uptake of new nonthermal technology (ie, chemical adhesives) was greatest among APPs (OR, 3.57; 95% CI, 3.43-3.70) and cardiologists (OR, 1.86; 95% CI, 1.81-1.91). Vascular surgeons were less likely to use nonthermal modalities (OR, 0.95; 95% CI, 0.92-0.97), including new nonthermal technology in the first year of availability (OR, 0.93; 95% CI, 0.90-0.95).
Conclusions
The use of venous procedures has increased rapidly during the past decade, particularly as endovenous ablations have been performed by a wider practitioner base, including APPs and noninterventionalists. Practice patterns differ by provider type, with APPs and cardiologists skewing more toward nonthermal modalities, including more rapid uptake of new nonthermal technology. Provider-specific biases for specific ablation modalities might reflect differences in training, skill set, the need for capital equipment, clinical privileges, or reimbursement. These data could help to inform training paradigms, the allocation of resources, and evaluation of appropriateness in a real-world setting.
... Varicose veins, also known as superficial refluxing veins, affect up to 45% of the UK population. 1 Varicose veins not only reduce physical and mental health-related quality of life but also contribute significantly to chronic venous disease, which is responsible for over half of all cases of leg ulcers. [2][3][4] Superficial endovenous treatment (SET) offers a minimally invasive approach that can conveniently be performed in an outpatient setting. 5 Endovenous surgery stands as the recommended first choice management for symptomatic varicose veins, in line with NICE guidelines (CG168). ...
Introduction
Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56–70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective.
Methods and analysis
A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21–28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression.
Ethics and dissemination
Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences.
Trial registration number
ISRCTN18501431.
... Lower limb chronic venous insufficiency (CVI) is a common disease 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]. laser to ablate the vein's wall inducing the occlusion of the varicose vein due to the heat. ...
Thermoablative techniques currently represent, in accordance with international guidelines, the most used methods in the treatment of varicose veins. From some years, lasers with a wavelength greater than 1900 nm have been introduced for EndoVenous Laser Ablation (EVLA) treatment. However, currently, few clinical studies regarding this new technology are reported in the medical literature. The aim of this study is to evaluate outcomes at a 2-year follow-up (mid-term) of EVLA of varicose veins of the lower limbs using a 1940-nm laser and a new cylindric monoring fiber. This clinical trial was conducted as a multicenter, retrospective, non-randomized, non-blind clinical study. Ninety-three patients were enrolled for a total of one hundred consecutive procedures performed in the period between January 2021 and May 2021 in two Italian facilities. The primary efficacy endpoint was the occlusion rate of the treated vein immediately after surgery and at the follow-up (24 months). The secondary efficacy endpoint was the evaluation of the parameters of energy delivered during the procedure (power and linear energy density or LEED). The primary safety endpoints were the incidence of pain (1 day and 7 days after surgery) and the rate of intraoperative and postoperative complications. The precepted pain was evaluated with the visual analog scale (VAS). The secondary safety endpoint was the evaluation of the improvement of the patient’s symptoms related to venous disease. This evaluation was conducted by recording the changes in clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification. All procedures were carried out regularly on an outpatient basis, and no intraoperative complications occurred. The occlusion rate of the target veins was 100% at 7- and 30-day controls. At follow-up controls, performed at 6 months, 1 and 2 years carried out showed an occlusion rate respectively of 99% (97 to 100), 96.9% (93.6 to 100), and 95.9% (92.1 to 99.9). The secondary efficacy endpoint was the evaluation of the parameters of energy delivered during the procedure (power watt and linear energy density): As regards the power parameters, we report an average of watts of 4.5 ± 0.8 [2.5 to 6] and linear energy density delivered (LEED) of 41.2 ± 8.6 [(21.1 to 66.7)]. The pain reported (with VAS scale) on 1 day of the procedure was 2 [1; 3] and 1 [0 to 4] at 7 days. All patients showed improved symptoms related to venous disease, with reduction of the individual CEAP class to which they belong. This study demonstrates that EndoVascular Laser Ablation (EVLA) treatment of varicose veins with a wavelength > 1900 nm is safe and effective. The overall occlusion rate was high. The reported results suggest that using lower parameters, such as output power (watts) and LEED (linear energy density), do not reduce the success rate of the treatment when used over 35 J/cm.
... It is thought to consume up to 2% of healthcare budgets in Western countries. 4,5 A recent meta-analysis concluded that there is a need for more extensive economic evaluations (costeutility, costebenefit, and or cost effectiveness analysis) of SVI treatments. 6 The patients with the most severe SVI with venous ulcers (C6 according to C in CEAP [Clinical-Etiology-Anatomy-Pathophysiology] classification system) 7 represent the highest disease burden and the greatest cost for society. ...
... No entanto, a progressão de IVC é lenta, podendo levar cerca de décadas para seu surgimento, e grande parte dos pacientes não apresenta uma sintomatologia linear, o que Brazilian Journal of Development, Curitiba, v.9, n.10, p. 29036-29044, oct., 2023 dificulta a confecção de estudos para análise de fatores predisponentes a úlcera venosa (LEE et al., 2015;MEULENDIJKS et al., 2019). Embora o surgimento de úlceras venosas seja relativamente raro, ela tem grande impacto na qualidade de vida dos indivíduos, por isso a identificação e o controle de fatores de risco para o desenvolvimento de úlceras venosas em pacientes com IVC se faz imperativo (CARRADICE et al., 2011;JONES et al., 2008;LOZANO SÁNCHEZ et al., 2014;MEULENDIJKS et al., 2019). ...
A insuficiência venosa crônica (IVC) é uma condição frequente no mundo, sendo que cerca de 40% dos indivíduos manifestam algum tipo de sintoma durante sua vida. Embora o surgimento de úlceras venosas seja relativamente raro, ela tem grande impacto na qualidade de vida dos indivíduos, por isso a identificação e o controle de fatores de risco para o desenvolvimento de úlceras venosas em pacientes com IVC se fazem imperativo. Portanto, o objetivo desta revisão narrativa é identificar os possíveis fatores de risco associados ao surgimento de úlceras venosas em pacientes com IVC. Este estudo é uma revisão narrativa. Foram incluídos artigos disponíveis da base de dado Pubmed publicados entre 2002 e 2023. Diversos fatores de risco foram identificados, como por exemplo, idade avançada, hipertensão arterial sistêmica (HAS), doença pulmonar obstrutiva crônica, histórico familiar, refluxo venoso, trombose de veia profunda, pacientes classificados como C4. Outros fatores como atividade física foram observados como fator protetor. A identificação destes fatores de risco, principalmente dos modificáveis é de suma importância para não só a prevenção como o tratamento de úlceras venosas, visto que o tratamento do fator risco, tende a diminuir chance do surgimento da úlcera.
... 43 The QoL of patients with ulcerations from venous insufficiency is poor and has been reported to be comparable with that of patients with congestive heart failure or chronic lung disease. 44 More than 60% of ulcers last >6 months and 20% last for >5 years; recurrence rates are also high, at *45%. 45 Venous leg ulcerations (Fig. 1F, G) are associated with a range of incapacitating symptoms. ...
Stasis dermatitis (SD), an inflammatory dermatosis occurring on the lower extremities, is a cutaneous manifestation of chronic venous insufficiency (CVI). SD is associated with a significant burden of disease. Symptoms such as pain, swelling, and itching can be debilitating for patients, leading to poor sleep, loss of mobility, and the inability to perform daily activities, and can interfere with work and leisure activities. Moreover, SD is a progressive disease with serious secondary complications such as ulcerations, which increase the patients' morbidity, reduce their quality of life, and increase health care burden. Challenges in diagnosing patients may have both short- and long-term sequalae for the patients due to unnecessary treatment and management. In addition, misdiagnosis may result in hospitalizations, placing additional burden on health care professionals in terms of time and financial burden on the health care system. Compression therapy and leg elevation represent the mainstay of treatment for CVI; however, it is also difficult to self-manage, which places a substantial burden on patients and caregivers. Moreover, compression therapy may cause discomfort and exacerbate itching. Subsequent nonadherence may result in disease progression that places additional burden on the physicians who manage these patients and the health care system in terms of resources required and costs incurred. A large proportion of patients with SD develop allergic contact dermatitis because of innate immune signals and altered skin barrier predisposing to sensitization to topical prescriptions, over-the-counter medications, and compression devices used to treat SD. Other than topical corticosteroids, there are no approved pharmacological options to treat inflammation in SD.
... The condition is gradually progressive, with 5% of patients experiencing more advanced symptoms every year [10]. Quality of life can be impacted, at both the physical and the psychological levels, at all stages of the condition [11][12][13]. CVD also places a heavy burden on healthcare systems, representing up to 3% of total healthcare budgets in developed countries [14][15][16][17]. ...
VEIN STEP was conducted to collect international data on the management of chronic venous disease (CVD) and to assess the effectiveness of conservative treatments for the relief of CVD signs and symptoms.
This international, observational, prospective, longitudinal, cohort study recruited adult outpatients consulting for symptomatic CVD. The primary objective was the effectiveness of conservative treatments on symptoms, signs and quality of life in a real-life setting assessed using a range of patient-reported outcome measures: 10-cm Visual Analog and Patient Global Impression of Change scales for symptoms; Venous Clinical Severity Score for physician assessment of signs; and 14-item ChronIc Venous Insufficiency Questionnaire (CIVIQ-14) for quality of life. At inclusion, patients were prescribed conservative treatment according to the physicians’ usual practice. Follow-up visits took place at weeks 2 and 4, with an optional week 8 visit.
The analysis set comprised 6084 subjects (78% female) from nine countries with a mean age of 50.6 ± 13.8 years and BMI of 28.0 ± 4.9 kg/m2. The most common CEAP classifications were C1 (23.0%), C2 (31.6%), and C3 (30.7%). Conservative therapy consisted of oral venoactive drugs (VADs; 95.8% of subjects) including micronized purified flavonoid fraction (MPFF 75.5%) and diosmin (18.8%), compression (52.0%), and topicals (31.5%). Conservative therapy led to global symptom improvement in 89% of patients after 2 weeks and 96% at 4 weeks. Pain, leg heaviness, cramps, and sensation of swelling were improved in 82%, 71%, 45.5%, and 46% of patients, respectively. Conservative therapy was associated with a decrease over time in patient-assessed global symptom intensity: – 2.37 ± 1.73 (P < 0.001) and physician-assessed disease severity – 1.83 ± 2.82 (P < 0.001). Among the VADs, MPFF-based conservative therapy was associated with the greatest reduction in symptom and sign intensity. Improvements in CIVIQ-14 were observed with all treatments but were greatest for MPFF.
In this prospective study conducted in the real-world setting, treatment with conservative therapy, in particular MPFF, was associated with meaningful improvements in the clinical signs and symptoms of disease as well as in quality of life in patients with CVD.
ClinicalTrials.gov identifier NCT04574375.
... Therefore, it is not surprising that CVD has a negative impact on QoL from the very earliest stages of the disease. Data show that QoL is impaired in patients with CVD classified as C2 to C6 on the Clinical, Etiological, Anatomical and Pathophysiological (CEAP) classification, and at all levels of the Venous Clinical Severity Score (VCSS), and worsens with increasing disease severity [5]. Patients with venous ulceration have a QoL that is comparable to people with congestive heart failure [6]. ...
Chronic venous disease (CVD) has a negative impact on patients' quality of life (QoL). This was demonstrated in the recent Patient Journey on CVD study, which examined QoL in patients with early- and advanced-stage CVD (Clinical, Etiological, Anatomical and Pathophysiological classification C0 to C4), and the gaps between the way in which physicians and patients viewed the impact of CVD on QoL. The study was conducted in five countries (Brazil, China, Czech Republic, Italy and Russia) and included 100 patients with CVD and 60 CVD specialists. Patients completed the 14-item Chronic Venous Insufficiency Questionnaire (CIVIQ-14) to assess their QoL, and all patients and physicians were questioned during a 60-minute qualitative structured interview, focusing on four key dimensions-physical symptoms, aesthetics/appearance, emotional impact and impact on relationships. The study found that physicians tended to focus more on physical symptoms than on other impacts of CVD and rarely measured QoL in clinical practice. Patients were significantly less satisfied with the management of their QoL than physicians perceived them to be. About 25% of patients with CVD reported disturbed sleep, but physicians did not routinely ask them how CVD affected their sleep. These data reinforce the importance of physicians obtaining information about the impact of CVD on all aspects of the patient's life, including sleep and QoL. Evidence from randomised controlled trials and real-world studies demonstrates that some veno-active drugs, particularly micronised purified flavonoid fraction, can positively impact QoL in patients with CVD.
... 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. ...
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]. ...
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.
... [2][3][4][5][6] Its prevalence increases with age and can impose a significant burden on patients' quality of life. 7,8 In the United States (US), >25 million adults have chronic venous insufficiency (CVI). 8 Studies on the prevalence of varicose veins have reported values as high as 57% in men and 73% in women. ...
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.
... [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. ...
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. ...
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]. ...
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). ...
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. ...
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) . ...
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. ...
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. ...
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.
Objectives: To discover the maximum risk acceptable to patients and clinicians for complications typical to endovascular interventions in the setting of proximal deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS).
Design: This was an observational study comparing patient/clinician risk acceptances in interviews using validated Standard Gamble methodology.
Methods: 30 patients with previous DVT and 30 vascular clinicians were given a scenario describing a hypothetical case of a patient being managed with acute iliofemoral DVT and another with PTS. Subjects were asked to provide the maximum risk they would accept for individual complications to cure the condition. To interpret variability, the Venous Clinical Severity Score, SF-36 domains and VEINES-QoL for each patient were plotted against their risk acceptance for major bleeding in the DVT scenario.
Results: For the DVT scenario, patients accepted high median risks compared to clinicians for major bleeding (40% vs 5%, p < .001), bleeding at other sites (50% vs 5%, p < .001), damage to blood vessels (60% vs 5%, p < .001), further procedures (80% vs 20%, p < .001), and treatment failure (75–80% vs 10–20%, p < .001). However, the gap was lower for intracranial bleeding (5% vs 1%, p = .004), pulmonary embolism (5 vs 5%, p = .39) or death (1% vs 0.75%, p = .77). For the PTS scenario, there were similar results again with a lower difference for pulmonary embolism (10% vs 5%, p = .02) and death (0.5% vs 1%, p = .72). Importantly, patient risk acceptance for major bleeding was negatively correlated to the emotional wellbeing (Rho = −0.43, p = .018) and social functioning (Rho = −0.38, p = .042) SF-36 domains.
Conclusion: Overall, patients accepted a greater chance of most adverse events compared with clinicians. Patients prepared to accept greater risk were those with poorer emotional wellbeing and social functioning. It is important to take these issues into account when making shared decisions with patients about the management of their DVT/PTS.
Background
Venous leg ulcers (VLUs) cause significant impairment to patients’ quality of life (QoL) and up to 30% do not heal at 6 months. Decellularized dermis (DCD) allografts have been shown to be effective in improving healing rates of diabetic foot ulcers in RCTs. The DAVE RCT aimed to determine whether DCD is an effective, safe, and cost-effective treatment adjunct for VLUs.
Methods
This was a multicentre RCT performed in the UK. Patients with lower limb ulcers ≥18 years with VLU, venous incompetence on duplex ultrasound, an ankle : brachial pressure index ≥ 0.8 and an index VLU present for at least 3 months and ≥2 cm2 in size were included. Patients were randomized to either the intervention (DCD graft and standard of care) or control arm (standard of care alone). The primary outcome was the proportion of patients with a healed index ulcer at 12 weeks.
Results
From October 2019 to October 2022, 36 and 35 participants were randomized into the intervention and control arms respectively. Patient characteristics at baseline were similar between groups. Healing was recorded in 5.7% of the intervention group and 15.2% in the control group (OR 0.34, 95% c.i. 0.03 to 2.31). There were no significant differences in the secondary outcomes including the percentage change in ulcer area, time to healing, recurrence rates, and QoL. There were five serious adverse events attributed to DCD application. Early trial termination was advised after the interim data analysis due to a lower-than-expected primary outcome rate (11.3%).
Conclusions
Decellularized dermis grafts did not improve healing rates of venous leg ulcers, although the trial was terminated early due to poor healing rates in both the intervention and control arms. Important clinical benefits or harms of decellularized dermis grafts could not be excluded due to the small sample size.
Trial registration
ISRCTN 21541209
Background
In recent years, tumescent ablative techniques have been joined by non-tumescent ablative techniques. The aim of the research is to study and compare the effects produced by the different endovascular ablative techniques, from the histological point of view, at the level of the venous wall (endothelium, tunica media and adventitia).
Method
The study involves the use of three ablative endovascular techniques (EVLA, MOCA, CGO) on bench for the treatment of the great saphenous vein. The bench procedure was performed in the same way as described in the instructions for use (IFU) of the technical specifications. Tissue samples were formalin-fixed and paraffin-embedded (FFPE). They were stained with hematoxylin and eosin and, in a case, with anti-ERG antibody (MA5-26,245, Termo Fisher).
Result
No perivascular tissue was present. No hematoma or perforation of the vein wall was observed. Histopathological changes after EVLA indicated that the intima including the endothelium and sub-endothelium was completely necrotized. It was observed that the thermal-energy-induced injury in the intima did not reach deeper than the media. Overview shows that in this case the damage is homogenously spread along the entire perimeter. The most evident change in the sample treated with mechanical-chemical ablation (MOCA) technique was the endothelial damage with loss of endothelial cells. Specifically, with the ERG immunostaining it was possible to observe the presence of numerous nuclei exposed towards the lumen of the vein. In the sample treated with cyanoacrylate (CGO), no significant structural alterations were observed. However, an almost complete collapse of the endoluminal walls and the presence of cyanoacrylate residues were observed.
Conclusion
Different histological patterns characterize the individual treatments. However, all techniques have a common feature: the damage is not transmural and the three different layers of the venous walls are always recognizable.
Objective: A prospective cohort study aimed to determine factors which influence the progression of chronic venous disease (CVD) in an attempt to aid in the early identification of those at patients who are likely to benefit from early intervention.
Methods: A prospective cohort study of patients referred to tertiary vascular services with varicose veins over 7 years was conducted. The primary outcome measure was the rate of disease progression from time of referral to time of consultation. The secondary outcome measure was to the rate of venous complications during the same time period.
Results: 1000 patients from routine varicose vein waiting lists were included in the study. The mean waiting time was 2.96 ± 1.25 years. The majority of patients were female (73% versus 27%), and the average age was 57.8 ± 14.7 years. One fifth of the cohort developed a complication or showed evidence of disease progression. Logistic regression showed that advancing age and previous episodes of cellulitis are significant risk factors for the development of CVD progression.
Conclusions: Varicose veins are more than a cosmetic issue and can be associated with substantial health and economic costs. Continuous identification of risk factors will enable clinicians to implement treatment strategies earlier for at risk patients.
Introduction:
Chronic venous disease (CVD) can lead to considerable morbidity and impact health-related quality of life (HRQoL). The aim of this review was twofold: (i) to provide a deeper understanding of how CVD affects HRQoL (physical, psychological and social functioning), and (ii) to review the impact of evidence-based veno-active drugs (VADs) on HRQoL.
Evidence acquisition:
For the effect of CVD on HRQoL, information was gathered during an Expert Consensus Meeting, during which data were presented from both the patient and physician perspective assessed with validated quality-of-life measures. For the impact of VADs on HRQoL, a systematic literature review was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Electronic databases were searched for real world evidence or randomized-controlled trials (RCT) vs. placebo, reporting data on the influence of VADs on HRQoL in patients with CVD.
Evidence synthesis:
CVD can negatively affect daily life in a number of areas related to pain, physical function and social activities. The impact of CVD on HRQoL begins early in the disease and for patients the emotional burden of the disease is as high as the physical burden. In contrast, physicians tend to overestimate the physical impact. The database search yielded 184 unique records, of which 19 studies reporting on VADs and HRQoL in patients with CVD met the inclusion criteria (13 observational and 6 RCTs). Micronized purified flavonoid fraction (MPFF) was the most represented agent, associated with 12/19 studies (2 RCTs and 10 observational). Of the 6 RCTs, only MPFF, aminaphthone and low-dose diosmin provided statistically significant evidence for improvement on HRQoL compared with placebo; for the other VADs improvements in HRQoL were not statistically different from placebo. MPFF was also associated with improvements in HRQoL in the observational studies, across all CEAP clinical classes, as monotherapy or in combination with other conservative therapy, and for all aspects of HRQoL: physical, psychological, and social. Real-world data for the other VADs were scarce. Ruscus extract, sulodexide and a semi-synthetic diosmin were each represented by a single observational study and these limited data were associated with statistically significant improvements compared with baseline in overall and subdomain scores across the range of CEAP clinical classes.
Conclusions:
CVD can impair patients' HRQoL significantly at all stages of the disease. MPFF has the greatest evidence base of clinical use in both RCT and real-world observational studies for effectiveness on HRQoL and is recognized by international guidelines.
Background
Vein ablation is a common and effective treatment for patients with chronic venous insufficiency. The overuse of vein ablation despite the existence of evidence-based guidelines has resulted in insurance companies developing restrictive policies for coverage that create barriers to appropriate care. This study compares the insurance coverage by single-state carriers (SSCs) and multistate carriers (MSCs), highlighting the variations and inconsistencies in the various policies.
Methods
The American Venous Forum Venous Policy Navigator was reviewed for the various policies available in the United States. The policies were divided into SSCs and MSCs. The characteristics of the policies, including the anatomic and hemodynamic criteria for specific veins, duration of conservative treatment, disease severity, symptoms, and types of procedures covered, were compared between the two groups. SAS, version 9.4 (SAS Institute Inc) was used for statistical analysis.
Results
A total of 122 policies were analyzed and divided between SSCs (n = 85; 69.7%) and MSCs (n = 37; 30.3%). A significant variation was found in the size requirement for great saphenous vein ablation. Although 48% of the policies did not specify a size criterion, the remaining policies indicated a minimal size, ranging from 3 to 5.5 mm. However, no significant differences were found between SSCs and MSCs. Similar findings were encountered for the small and anterior accessory saphenous veins. MSCs were more likely to define a saphenous reflux time >500 ms compared with SSCs (81.1% vs 58.8%; P = .04). A significant difference was found between the SSCs and MSCs in the criteria for perforator ablation in terms of size and reflux time. MSCs were significantly more likely to provide coverage for mechanochemical ablation than were SSCs (24.3% vs 8.2%; P = .03). SSCs were more likely to require ≥12 weeks of compression stocking therapy than were MSCs (76.5% vs 48.7%; P = .01). No significant differences were found in the clinical indications between the two groups; however, MSCs were more likely to mention major hemorrhage than were SSCs.
Conclusions
The results of this study highlight the variations in policies for venous ablation, in particular, the striking inconsistencies in size criteria. MSCs were more likely to cover mechanochemical ablation and require a shorter duration of conservative therapy before intervention compared with SSCs. Evidence-based guidance is needed to develop more coherent policies for venous ablation coverage.
Venous leg ulcers and chronic oedema including lymphoedema are lifelong conditions that cause great distress to sufferers due to psychophysical symptoms. Time and resources spent on managing chronic wounds place an economic burden on healthcare providers, particularly with an anticipated increase in an ageing population and diminishing numbers of those providing long-term care. Resources are further challenged if wounds remain unhealed. The human costs are even greater, with patients often facing a lifetime of discomfort due to low awareness of venous disease, despite epidemiological studies. Possible causes of persistent venous disease may be misdiagnosis, mismanagement, or simply, no management if help is not sought. Therefore, it is important that chronic leg ulcers are managed with clinically effective regimes, reassessment, monitoring and appropriate referrals for adjunct management, alongside patient education. This article provides simple timescaled measurements to ensure timely interventions and appropriate care at each stage.
Background:
The objective of this study was to compare the early and mid-term results of radiofrequency ablation and cyanoacrylate ablation used in the treatment of small saphenous insufficiency.
Methods:
A total of 84 patients with isolated small saphenous vein insufficiency who underwent either cyanoacrylate ablation (CA) (Group 1, n = 40) or radiofrequency ablation (RFA) (Group 2, n = 44) were analyzed retrospectively.
Results:
The occlusion rate of target vessel was 95% in Group 1 and 93.1% in Group 2 patients, respectively, at 1-year follow-up without any significant difference. Sural nerve injury was observed in 3 (6.8%) patients in Group 2 due to the thermal damage of the RFA device.
Conclusions:
While both techniques can be used with satisfactory and safe results in 1-year follow-up period, cyanoacrylate ablation may have a better safety profile compared to radiofrequency ablation due to lower complication rates in terms of paresthesia and sural nerve damage with similar occlusion rates.
Background:
Venous leg ulcers (VLUs) are a serious manifestation of chronic venous disease affecting up to 3% of the adult population. This typically recalcitrant and recurring condition significantly impairs quality of life, and its treatment places a heavy financial burden upon healthcare systems. The longstanding mainstay treatment for VLUs is compression therapy. Surgical removal of incompetent veins reduces the risk of ulcer recurrence. However, open surgery is an unpopular option amongst people with VLU, and many people are unsuitable for it. The efficacy of the newer, minimally-invasive endovenous techniques has been established in uncomplicated superficial venous disease, and these techniques can also be used in the management of VLU. When used with compression, endovenous ablation aims to further reduce pressure in the veins of the leg, which may impact ulcer healing.
Objectives:
To determine the effects of superficial endovenous ablation on the healing and recurrence of venous leg ulcers and the quality of life of people with venous ulcer disease.
Search methods:
In April 2022 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scrutinised reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions on the language of publication, but there was a restriction on publication year from 1998 to April 2022 as superficial endovenous ablation is a comparatively new technology.
Selection criteria:
Randomised controlled trials (RCTs) comparing endovenous ablative techniques with compression versus compression therapy alone for the treatment of VLU were eligible for inclusion. Studies needed to have assessed at least one of the following primary review outcomes related to objective measures of ulcer healing such as: proportion of ulcers healed at a given time point; time to complete healing; change in ulcer size; proportion of ulcers recurring over a given time period or at a specific point; or ulcer-free days. Secondary outcomes of interest were patient-reported quality of life, economic data and adverse events.
Data collection and analysis:
Two reviewers independently assessed studies for eligibility, extracted data, carried out risk of bias assessment using the Cochrane RoB 1 tool, and assessed GRADE certainty of evidence.
Main results:
The previous version of this review found no RCTs meeting the inclusion criteria. In this update, we identified two eligible RCTs and included them in a meta-analysis. There was a total of 506 participants with an active VLU, with mean durations of 3.1 months ± 1.1 months in the EVRA trial and 60.5 months ± 96.4 months in the VUERT trial. Both trials randomised participants to endovenous treatment and compression or compression alone, however the compression alone group in the EVRA trial received deferred endovenous treatment (after ulcer healing or from six months). There is high-certainty evidence that combined endovenous ablation and compression compared with compression therapy alone, or compression with deferred endovenous treatment, improves time to complete ulcer healing (pooled hazard ratio (HR) 1.41, 95% CI 1.36 to 1.47; I2 = 0%; 2 studies, 466 participants). There is moderate-certainty evidence that the proportion of ulcers healed at 90 days is probably higher with combined endovenous ablation and compression compared with compression therapy alone or compression with deferred endovenous treatment (risk ratio (RR) 1.14, 95% CI 1.00 to 1.30; I2 = 0%; 2 studies, 466 participants). There is low-certainty evidence showing an unclear effect on ulcer recurrence at one year in people with healed ulcers with combined endovenous treatment and compression when compared with compression alone or compression with deferred endovenous treatment (RR 0.29, 95% CI 0.03 to 2.48; I2 = 78%; 2 studies, 460 participants). There is also low-certainty evidence that the median number of ulcer-free days at one year may not differ (306 (interquartile range (IQR) 240 to 328) days versus 278 (IQR 175 to 324) days) following combined endovenous treatment and compression when compared with compression and deferred endovenous treatment; (1 study, 450 participants). There is low-certainty evidence of an unclear effect in rates of thromboembolism between groups (RR 2.02, 95% CI 0.51 to 7.97; I2 = 78%, 2 studies, 506 participants). The addition of endovenous ablation to compression is probably cost-effective at one year (99% probability at GBP 20,000/QALY; 1 study; moderate-certainty evidence).
Authors' conclusions:
Endovenous ablation of superficial venous incompetence in combination with compression improves leg ulcer healing when compared with compression alone. This conclusion is based on high-certainty evidence. There is moderate-certainty evidence to suggest that it is probably cost-effective at one year and low certainty evidence of unclear effects on recurrence and complications. Further research is needed to explore the additional benefit of endovenous ablation in ulcers of greater than six months duration and the optimal modality of endovenous ablation.
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, the majority of 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Quantification of venous reflux is still a matter of debate. Our goal was to compare the duplex-derived parameters between patients with early and advanced chronic venous insufficiency (CVI), and to determine indicative parameters reflecting the progression of CVI.
A total of 1,132 limbs in 914 patients with primary valvular incompetence were included. Clinical manifestations were categorized according to the CEAP (clinical, etiologic, anatomic, and pathophysiologic) classification, and the patients were divided into two groups: group I (those with relatively early CVI, C(1-3)E(P),A(S,D,P),P(R)) and group II (those with advanced CVI, C(4-6)E(P),A(S,D,P),P(R)). The distribution of venous insufficiency was determined, and the parameters assessed were the duration of reflux (s), the peak reflux velocity (cm/s), and the flow at peak reflux (mL/s).
There was no notable difference in overall superficial venous reflux between the groups, and the frequency of isolated deep and perforator incompetence did not differ between the groups. The duration of reflux did not improve the discrimination power between the groups. In contrast, the peak reflux velocity had significant discrimination power at the saphenofemoral junction (p < 0.0001), the saphenopopliteal junction (p = 0.0002), in the greater saphenous vein (p < 0.0001), in the superficial femoral vein (p = 0.0041), and in the popliteal vein (p = 0.003). The peak reflux flow was significantly higher in group II at the saphenofemoral junction (p < 0.0001), the saphenopopliteal junction (p = 0.0029), in the greater saphenous vein (p < 0.0001), in the common femoral vein (p = 0.006), in the superficial femoral vein (p = 0.0005), and in the popliteal vein (p = 0.0003).
Superficial venous insufficiency might play a major role in the development of advanced CVI. The peak reflux velocity and peak reflux volume improve discrimination power between early-stage and advanced CVI.
Clinical classifications attempt to summarize a large amount of information in a few indices. CEAP is the most comprehensive and widely used classification of chronic venous disorders. The objective was to evaluate, in a routine clinical setting, the information associated with each CEAP clinical class and their ascending severity and additivity.
This work was a multicenter evaluation of newly designed software dedicated to the management of venous diseases. Forty-nine angiologists from nine European countries entered a total of 872 full records of unselected patients. The data were analyzed to evaluate the informational value of each of the clinical classes and to test their ascending severity and additivity, with monovariate and multivariate statistical techniques with SPSS/PC software on the database of the 872 right lower limbs.
The series consisted of 700 women (80.3%) and 172 men, aged 18 to 100 years (median, 53 years). The ascending severity of the classes was shown with the statistical association of higher severity C classes with the age of the patient, a history of previous deep vein thrombosis, the diameter class of the most dilated varicose vein, venous symptoms, and the presence of a corona phlebectatica. The additivity, as measured with the Cronbach alpha coefficient analysis, was satisfactory in highest classes but poorer within the first three classes, and factor analysis of correspondences showed the heterogeneity of the variables that make the classification.
The information summarized with the CEAP clinical classes shows a good ascending severity but a poorer additivity. These limitations seem to be related to the heterogeneity of the information content, which suggests some refinements of this basic tool for clinical research in the field of chronic venous disorders.
We performed this observational study to validate the three components of a new venous severity scoring (VSS) system, ie, venous clinical severity score (VCSS), venous segmental disease score (VSDS), and venous disability score (VDS), and to evaluate VCSS, VDS, and CEAP clinical class and score in quantifying outcome of varicose vein surgery. Patients and methods The study included 45 patients who underwent superficial venous surgery in 48 legs with primary varicose veins. Venous color duplex scanning, clinical examination, and a questionnaire were used preoperatively and at 6 weeks and 6 months postoperatively to assign VSS and CEAP clinical class and score.
CEAP clinical score, VCSS, and VDS demonstrated a linear association with CEAP clinical class (P <.001, P <.001, P =.002, respectively). Good correlation among all severity scores was found, particularly between CEAP clinical score and VCSS (r = 0.94; P <.001). CEAP clinical score was also highly correlated with CEAP clinical class (r = 0.84; P <.001) and VDS (r = 0.70; P <.001). Similarly, VCSS correlated with CEAP clinical class (r = 0.83; P <.001) and also VDS (r = 0.72; P <.001). The anatomic severity marker VSDS demonstrated a weak correlation with clinical severity indicators VCSS (r = 0.29; P =.048) and VDS (r = 0.31; P =.03) but not with age, gender, or CEAP clinical class and score. Six months after surgery the median (interquartile range) percent change in VCSS (73%; range, 50%-100%) and CEAP clinical score (70%; range, 50%-100%) were both significantly greater (P <.001) than the corresponding change in CEAP clinical class (17%; range, 0%-50%). In legs with high VDS at baseline, median (interquartile range) percent change in VDS was 100% (range, 50%-100%), significantly greater (P <.001) than the corresponding change in CEAP clinical class (0%; range, 0%-17%).
Venous severity scores are significantly higher in advanced venous disease, demonstrating correlation with anatomic extent. Both venous clinical severity scores, VCSS and CEAP clinical score, are equally sensitive and significantly better for measuring changes in response to superficial venous surgery than is the already in use CEAP clinical class. VDS demonstrated comparable and even better performance. Although the assignment of CEAP clinical class might be adequate for daily clinical purposes, venous severity scoring systems should be used in clinical studies to quantify venous outcome.
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 classi fication, 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 modi fication 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.
Some measure of disease severity is needed to properly compare the outcomes of the various approaches to the treatment of chronic venous insufficiency. Comparing the outcomes of two or more different treatments in a clinical trial, or the same treatment in two or more reports from the literature cannot be done with confidence unless the relative severity of the venous disease in each treatment group is known. The CEAP (Clinical-Etiology-Anatomic-Pathophysiologic) system is an excellent classification scheme, but it cannot serve the purpose of venous severity scoring because many of its components are relatively static and others use detailed alphabetical designations. A disease severity scoring scheme needs to be quantifiable, with gradable elements that can change in response to treatment. However, an American Venous Forum committee on venous outcomes assessment has developed a venous severity scoring system based on the best usable elements of the CEAP system. Two scores are proposed. The first is a Venous Clinical Severity Score: nine clinical characteristics of chronic venous disease are graded from 0 to 3 (absent, mild, moderate, severe) with specific criteria to avoid overlap or arbitrary scoring. Zero to three points are added for differences in background conservative therapy (compression and elevation) to produce a 30 point-maximum flat scale. The second is a Venous Segmental Disease Score, which combines the Anatomic and Pathophysiologic components of CEAP. Major venous segments are graded according to presence of reflux and/or obstruction. Ir is entirely based on venous imaging, primarily duplex scan but also phlebographic findings. This scoring scheme weights 11 venous segments for their relative importance when involved with reflux and/or obstruction, with a maximum score of 10. A third score is simply a modification of the existing CEAP disability score that eliminates reference to work and an 8-hour working day, substituting instead the patient's prior normal activities. These new scoring schemes are intended to complement the current CEAP system.
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.
Objective:
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.
Design:
Postal questionnaire, followed up by two reminders at two week intervals.
Setting:
Clinics and four training practices in north east Scotland.
Subjects:
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.
Main outcome measures:
The eight scales within the SF36 health profile.
Results:
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.
Conclusions:
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.
Numerous rules-of-thumb have been suggested for determining the minimum number of subjects required to conduct multiple regression analyses. These rules-of-thumb are evaluated by comparing their results against those based on power analyses for tests of hypotheses of multiple and partial correlations. The results did not support the use of rules-of-thumb that simply specify some constant (e.g., 100 subjects) as the minimum number of subjects or a minimum ratio of number of subjects (N) to number of predictors (m). Some support was obtained for a rule-of-thumb that N ≥ 50 + 8 m for the multiple correlation and N ≥104 + m for the partial correlation. However, the rule-of-thumb for the multiple correlation yields values too large for N when m ≥ 7, and both rules-of-thumb assume all studies have a medium-size relationship between criterion and predictors. Accordingly, a slightly more complex rule-of thumb is introduced that estimates minimum sample size as function of effect size as well as the number of predictors. It is argued that researchers should use methods to determine sample size that incorporate effect size.
In the course of developing a standardised, non-disease-specific instrument for describing and valuing health states (based on the items in Table 1), the EuroQol Group (whose members are listed In the Appendix) conducted postal surveys in England, The Netherlands and Sweden which indicate a striking similarity in the relative valuations attached to 14 different health states (see Table 3). The data were collected using a visual analogue scale similar to a thermometer (see Table 2). The EuroQol Instrument Is Intended to complement other quality-of-life measures and to facilitate the collection of a common data set for reference purposes. Others interested in participating in the extension of this work are invited to contact the EuroQol Group.
Endovenous laser ablation (EVLA) is a popular minimally invasive treatment for varicose veins. Surgical treatment, featuring junctional ligation and inversion stripping, has shown excellent clinical and cost effectiveness. The clinical effectiveness of both treatments was compared within a randomized trial.
Some 280 patients were randomized equally into groups receiving either surgery or EVLA. Participants had primary, symptomatic, unilateral venous insufficiency, with isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein. Outcomes included: quality of life (QoL), Venous Clinical Severity Score (VCSS), pain scores and time taken to return to normal function. Owing to the nature of the procedures, blinding was not possible.
Both groups had significant improvements in VCSS after treatment (P < 0.001), which resulted in improved disease-specific QoL (Aberdeen Varicose Vein Questionnaire, P < 0.001) and quality-adjusted life year (QALY) gain (P < 0.001). The pain and disability following surgery impaired normal function, with a significant decline in five of eight Short Form 36 (SF-36(®)) domains (P < 0.001 to P = 0.029). Periprocedural QoL was relatively preserved following EVLA, leading to a significant difference between the two treatments in pain scores (P < 0.001), six of eight SF-36(®) domains (P = 0.004 to P = 0.049) and QALYs (P = 0.003). As a result, surgical patients took longer to return to work and normal activity (14 versus 4 days; P < 0.001). Complications were rare.
EVLA was as effective as surgery for varicose veins, but had a less negative impact on early postintervention QoL. Registration number: NCT00759434 (http://www.clinicaltrials.gov).
The management of residual varicosities following endovenous laser therapy (EVLT) for varicose veins is contentious. Ambulatory phlebectomy may be performed concomitantly with the initial EVLT, or sequentially as a secondary procedure. This randomized trial compared these two approaches.
Fifty patients with great saphenous varicose veins were randomized to EVLT alone or EVLT with concomitant ambulatory phlebectomies (EVLTAP). Principal outcomes were procedure duration, pain scores, requirement for secondary procedures and quality of life after 3 months.
EVLTAP took longer, but significantly decreased the requirement for subsequent interventions. There was no impairment in immediate postprocedural pain, Short Form 36 or EuroQol 5D scores with EVLTAP. Median (i.q.r.) Venous Clinical Severity Score (VCSS) at 3 months was lower for EVLTAP than for EVLT alone (0 (0-1) versus 2 (0-2); P < 0.001), with lower Aberdeen Varicose Vein Questionnaire (AVVQ) scores at 6 weeks (7.9 (4.1-10.7) versus 13.5 (10.9-18.1); P < 0.001) and 3 months (2.0 (0.4-7.7) versus 9.6 (2.2-13.8); P = 0.015). At 1 year, there were no differences in VCSS or AVVQ scores.
Concomitant phlebectomy with EVLT prolonged the procedure, but reduced the need for secondary procedures and significantly improved quality of life and the severity of venous disease.
In 1999, a survey was published detailing the management of varicose veins by members of the then Vascular Surgical Society (VSS). Since then, newer methods for treating varicose veins have been developed and far more explicit rationing has been introduced in the NHS.
In order to examine whether there had been a significant change in established practice in the UK, a questionnaire was sent to all Vascular Society of Great Britain and Ireland (VSGBI) members in the 2004 yearbook by E-mail or post.
Of the 426 questionnaires distributed, a 69% response rate was achieved. Of respondents, 97% treated varicose veins in their NHS practice, whilst 88% did so in private practice. Some 73% used hand-held Doppler assessment in the clinic and 96% used duplex ultrasound assessment selectively. Despite UK National Institute for Health and Clinical Excellence (NICE) guidelines, only 68% said that their primary care trusts funded treatment of symptomatic varicose veins, while 93% did so for complications. In either NHS or private practice, respectively, 83% or 72% of responders offered surgery as preferred treatment for primary varicose veins, while 14% or 20% preferred endovascular treatments (endovascular laser treatment, radiofrequency ablation and foam sclerotherapy). Of responders, 17% did not follow-up patients after treatment.
This survey suggests that there is rationing of access to care for symptomatic varicose veins. Despite publicity for endovenous techniques, surgery remains the preferred treatment for varicose veins in the UK.
This study estimated the validity and relative precision (RP) of four methods (MOS long- and short-form scales, global items, and COOP Poster Charts) in measuring six general health concepts. The authors also tested whether and how precisely each method discriminated relatively well adult patients (N = 638) from those with only severe chronic medical (N = 168) and only psychiatric conditions (N = 163), as clinically defined. For comparisons between the well group and both medical and psychiatric groups, RP estimates favored long-form over short-form, multi-item scales, and favored multi-item scales over single-item global measures and poster charts. In relation to long forms, short-form multi-item scales achieved a median RP of .93; RP estimates for global items and poster charts were .81 and .67, respectively. Variations in RP across methods and concepts were linked to differences in the coarseness of measurement scales, reliability, and content (including the effects of chart illustrations). These variations in RP have implications for the interpretation of scores, the statistical power of comparisons between clinical groups, and the size of confidence intervals around individual patient scores.
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.
Venous ulceration in the leg has been predominantly associated with deep venous insufficiency, although a few reports have implicated the superficial veins. The aim of this study was to identify the distribution of valvular incompetence in patients with active leg ulceration.
Color flow duplex imaging (CFDI) ultrasonography was used to evaluate the entire venous system--superficial, perforator and deep--from groin to ankle in 112 limbs of 94 patients with venous leg ulcers.
Seventy two limbs (64%) had multisystem incompetence and 36 (32%) had one system involved only, whereas in 4 limbs (4%) there was no venous incompetence. Deep venous reflux exclusively was present in 7 limbs (6%) and the perforator system alone was involved only in 3 limbs (3%). However, isolated superficial incompetence was seen in 26 extremities (23%) and combination of superficial with perforator system alone in 23 (21%). In addition, reflux overall in the superficial system (alone and in combination with perforator and deep systems) was seen in 94 limbs (84%). The most common pattern (28%) of abnormality was reflux in all systems, superficial, perforator, and deep.
The results of this study show that variable combined patterns account for over two thirds of patients with ulceration. No comprehensive surgical policy for alleviating ulceration can be justified; we suggest that a complete evaluation of all venous systems from groin to ankle with CFDI ultrasonography in patients with venous ulceration is practical on a routine basis and will be particularly valuable before surgery in order to target intervention at specific incompetent sites.
Assessment and treatment of varicose veins comprises a significant part of the surgical workload. In the UK, National Health Service waiting lists suggest that there is still considerable unmet need. This review analyses all published data on the epidemiology of varicose veins, paying particular regard to the differing epidemiological terminology, populations sampled, assessment methods and varicose vein definitions, which account for much of the variation in literature reports. Half of the adult population have minor stigmata of venous disease (women 50-55 per cent; men 40-50 per cent) but fewer than half of these will have visible varicose veins (women 20-25 per cent; men 10-15 per cent). The data suggest that female sex, increased age, pregnancy, geographical site and race are risk factors for varicose veins; there is no hard evidence that family history or occupation are factors. Obesity does not appear to carry any excess risk. Accurate prevalence data allow provision of appropriate resources or at least aid rational debate if demand is greater than the resources available.
The widespread use of standardized health surveys is predicated on the largely untested assumption that scales constructed from those surveys will satisfy minimum psychometric requirements across diverse population groups. Data from the Medical Outcomes Study (MOS) were used to evaluate data completeness and quality, test scaling assumptions, and estimate internal-consistency reliability for the eight scales constructed from the MOS SF-36 Health Survey. Analyses were conducted among 3,445 patients and were replicated across 24 subgroups differing in sociodemographic characteristics, diagnosis, and disease severity. For each scale, item-completion rates were high across all groups (88% to 95%), but tended to be somewhat lower among the elderly, those with less than a high school education, and those in poverty. On average, surveys were complete enough to compute scales scores for more than 96% of the sample. Across patient groups, all scales passed tests for item-internal consistency (97% passed) and item-discriminant validity (92% passed). Reliability coefficients ranged from a low of 0.65 to a high of 0.94 across scales (median = 0.85) and varied somewhat across patient subgroups. Floor effects were negligible except for the two role disability scales. Noteworthy ceiling effects were observed for both role disability scales and the social functioning scale. These findings support the use of the SF-36 survey across the diverse populations studied and identify population groups in which use of standardized health status measures may or may not be problematic.
Cross-sectional data from the Medical Outcomes Study (MOS) were analyzed to test the validity of the MOS 36-Item Short-Form Health Survey (SF-36) scales as measures of physical and mental health constructs. Results from traditional psychometric and clinical tests of validity were compared. Principal components analysis was used to test for hypothesized physical and mental health dimensions. For purposes of clinical tests of validity, clinical criteria defined mutually exclusive adult patient groups differing in severity of medical and psychiatric conditions. Scales shown in the components analysis to primarily measure physical health (physical functioning and role limitations-physical) best distinguished groups differing in severity of chronic medical condition and had the most pure physical health interpretation. Scales shown to primarily measure mental health (mental health and role limitations-emotional) best distinguished groups differing in the presence and severity of psychiatric disorders and had the most pure mental health interpretation. The social functioning, vitality, and general health perceptions scales measured both physical and mental health components and, thus, had the most complex interpretation. These results are useful in establishing guidelines for the interpretation of each scale and in documenting the size of differences between clinical groups that should be considered very large.
The purpose of this study was to identify the distribution of venous reflux in patients with different patterns of reflux with each class.
Color-flow duplex imaging was used to evaluate the entire venous system from groin to ankle in 465 patients (594 limbs) belonging to different clinical CVI classes (0, 1, 2, and 3). A history of previous superficial thrombophlebitis was present in five limbs and past deep vein thrombosis in 70.
One hundred seventy eight (30%) limbs were normal and the remaining 416 (70%) had venous incompetence. Deep reflux was present exclusively in 19 limbs (3.2%), and the perforation system alone was involved in only three limbs (0.5%). However, isolated superficial incompetence was seen in 186 limbs (31.3%) and a combination of superficial with perforating alone was involved in 45 (7.6%). Incompetence in all three systems was seen in 99 extremities (16.7%). In addition, the superficial system was involved in 390 limbs, the perforators in 151, and the deep system in 178 limbs. Only a small percentage of those in class 0 had reflux, and most of them had a single site of incompetence. In class 1 the majority of the limbs had superficial reflux (90.3%), 10.3% of the limbs had deep venous reflux, and 6.9% were competent. Reflux in the superficial system was only seen in 80.7% of the limbs in class 1 and in one fifth of the limbs in classes 2 and 3. Isolated deep or perforated incompetence was rare in all classes. Variable combined patterns of reflux were seen more often in classes 2 and 3 (p < 0.0001). In classes 2 and 3 there were no differences in the number of incompetent sites in the superficial and deep venous systems or the patterns of reflux (p > 0.1). The number of incompetent perforators in class 3 tended to be higher than that in class 2, especially in the below-knee segment, but no significant differences were seen. Distal reflux was present in the majority of the limbs in all symptomatic classes (1, 2, and 3).
The distribution and extent of reflux is strongly associated with clinical severity of CVI through class 2. Distal venous reflux is present in at least 80% of the symptomatic limbs. Deep venous thrombosis may not be a prerequisite for the development of skin changes or ulceration in about 75% of the limbs. Superficial venous surgery could be beneficial to at least one third of patients with skin changes or ulceration.
Advances in modern technology have made available a large number of both invasive and non-invasive investigations that can provide information not only on the presence, absence or anatomic extent but also quantitation of the abnormalities. It was soon realised that the combinations of presence, absence, extent and severity of reflux and/or obstruction in the deep, superficial or perforating veins are so large that the classification of chronic venous disease would be a major challenge. This challenge has been taken up by the Consensus Committee which met in Maui on 22-26 February 1995. The Consensus that developed is in three parts. Part I deals with a classification system that covers the Clinical picture, the Etiology, the Anatomic distribution and the Pathophysiology (the CEAP Classification). Part II suggests a scoring system intended to be evaluated on patients classified according to the CEAP classification, and Part III provides guidelines on the use of various investigations which according to the current medical literature will aid in the classification, The Consensus Committee has retained the copyright of the document so that it can be made available for reproduction to all interested parties. Reproduction is free provided there is no alteration and it is always reproduced in its entirety, The development of this consensus document is a continuous process. Suggestions for improvement are expected from all involved in the study and management of patients with chronic venous disease. The classification has already been presented and debated at several national and international meetings and plans for an updated version are already in progress.
Approaches to measuring patient perceptions of outcome for varicose veins were tested using a postal questionnaire incorporating a clinically derived specific measure of varicose veins severity and the SF-36 health survey. The questionnaire was administered to 373 patients with varicose veins, 287 of whom had been referred to hospital for their varicose veins and 86 who had just consulted a general practitioner for the condition. The response rate exceeded 75%. Test-retest reliability was assessed by mailing patients a similar questionnaire at two weeks. The validity of the two instruments was assessed by comparing patient scores to general practitioner ratings of symptom severity and complications associated with varicose veins. Standardized response means (mean change in scores divided by the standard deviation of the change in scores) were used to quantify and compare the responsiveness of the two measures. Levels of test-retest reliability, as assessed by the intraclass correlation coefficient, were acceptable and the instruments appear to have good levels of validity. Patients who were or were not admitted to hospital for surgery on their veins had significant improvements in perceived health status on both the specific measure and the SF-36. The specific measure was the most responsive to changes in health status for both patients who were admitted to hospital for surgery and those receiving alternative forms of management. These two approaches might be suitable as part of a package of outcome measures for use in clinical trials to assess the effectiveness of different interventions for varicose veins.
It has become increasingly common for preference-based measures of health-related quality of life to be used in the evaluation of different health-care interventions. For one such measure, The EuroQol, designed to be used for these purposes, it was necessary to derive a single index value for each of the 243 health states it generates. The problem was that it was virtually impossible to generate direct valuations for all of these states, and thus it was necessary to find a procedure that allows the valuations of all EuroQol states to be interpolated from direct valuations on a subset of these.
In a recent study, direct valuations were elicited for 42 EuroQol health states (using the time trade-off method) from a representative sample of the UK population. This article reports on the methodology that was adopted to build up a "tariff" of EuroQol values from this data.
A parsimonious model that fits the data well was defined as one in which valuations were explained in terms of the level of severity associated with each dimension, an intercept associated with any move away from full health, and a term that picked up whether any dimension in the state was at its most severe level.
The model presented in this article appears to predict the values of the states for which there are direct observations and, thus, can be used to interpolate values for the states for which no direct observations exist.
The prevalence of reflux in the deep and superficial venous systems in the Edinburgh population and the relationship between patterns of reflux and the presence of venous disease on clinical examination were studied.
A cross-sectional survey was done on men and women ranging in age from 18 to 64 years, randomly selected from 12 general practices. The presence of varicose veins and chronic venous insufficiency was noted on clinical examination, as was the duration of venous reflux by means of duplex scanning in 8 vein segments on each leg. Results were compared using cut-off points for reflux duration (RD) of 0.5 seconds or more (RD >/= 0.5) and more than 1.0 second (RD > 1.0) to define reflux.
There were 1566 study participants, 867 women and 699 men. The prevalence of reflux was similar in the right and left legs. The proportion of participants with reflux was highest in the lower thigh long saphenous vein (LSV) segment (18.6% in the right leg and 17.5% in the left leg for RD >/= 0.5), followed by the above knee popliteal segments (12.3% in the right leg and 11.0% in the left leg for RD >/= 0.5), the below knee popliteal (11.3% in the right leg and 9.5% in the left leg for RD >/= 0.5), upper LSV (10.0% in the right leg and 10.8% in the left leg for RD >/= 0.5) segments, the common femoral vein segments (7.8% in the right leg and 8.0% in the left leg for RD >/= 0.5), the lower superficial femoral vein (SFV) segments (6.6% in the right leg and 6.4% in the left leg for RD >/= 0.5), and the upper SFV (5.2% in the right leg and 4.7% in the left leg for RD >/= 0.5) and short saphenous vein (SSV) (4.6% in the right leg and 5.6% in the left leg for an RD >/= 0.5) segments. In the superficial vein segments, there was little difference in the occurrence of reflux whether RD >/= 0.5 or RD > 1.0 was used; but in the different deep vein segments, the prevalence of reflux was 2 to 4 times greater for RD >/= 0.5 rather than RD > 1.0. Men had a higher prevalence of reflux in the deep vein segments than women, reaching statistical significance (P </=.01) in 4 of 5 segments for RD >/= 0.5. In general, the prevalence of reflux increased with age. Those with "venous disease" had a significantly higher prevalence of reflux in all vein segments than those with "no disease" (P </=.001).
The prevalence of venous reflux in the general population was related to the presence of "venous disease," although it was also present in those without clinically apparent disease. There was a higher prevalence of reflux in the deep veins in men than the deep veins in women. Follow-up study of the population will determine the extent to which reflux is a predictor of future disease and complications.
To define the relations between age, sex, lower limb symptoms, and the presence of trunk varicose veins on clinical examination.
Cross sectional population study.
12 general practices with catchment areas geographically and socioeconomically distributed throughout Edinburgh.
An age stratified random sample of 1566 people (699 men and 867 women) aged 18-64 selected from the computerised age-sex registers of participating practices.
Self administered questionnaire on the presence of lower limb symptoms and physical examination to determine the presence and severity of varicose veins.
Women were significantly more likely than men to report lower limb symptoms such as heaviness or tension, swelling, aching, restless legs, cramps, and itching. The prevalence of symptoms tended to increase with age in both sexes. In men, only itching was significantly related to the presence and severity of trunk varices (linear test for trend, P=0.011). In women there was a significant relation between trunk varices and the symptoms of heaviness or tension (P</=0.001), aching (P</=0.001), and itching (P</=0.005). However, the level of agreement between the presence of symptoms and trunk varices was too low to be of clinical value, especially in men.
Even in the presence of trunk varices, most lower limb symptoms probably have a non-venous cause. Surgical extirpation of trunk varices is unlikely to ameliorate such symptoms in most patients.
This paper explores four definitions of equity in health care: equality of utilization, distribution according to need, equality of access, and equality of health. We argue that the definitions of 'need' in the literature are inadequate and propose a new definition. We also argue that, irrespective of how need and access are defined, the four definitions of equity are, in general, mutually incompatible. In contrast to previous authors, we suggest that equality of health should be the dominant principle and that equity in health care should therefore entail distributing care in such a way as to get as close as is feasible to an equal distribution of health.
We set out to assess the new Aberdeen Varicose Veins Questionnaire (Aberdeen Questionnaire) for the properties necessary for a valid measure of health outcome, to determine quality of life of patients with varicose veins, and to determine the effect of surgery on quality of life.
A prospective consecutive cohort of 137 patients undergoing varicose vein surgery completed the self-administered SF-36 and Aberdeen Questionnaire and 25 questions relating to the symptoms and concerns of patients with varicose veins. Follow-up was done by repeated questionnaires 6 weeks after surgery. The Aberdeen Questionnaire was assessed for reliability, validity, responsiveness, and practicality. Quality of life of patients with varicose veins was compared with an age- and sex-matched sample of the general population.
Reliability estimates for the 8 scales short-form health survey (SF-36) and the Aberdeen Questionnaire were all above 0.7 (Cronbach's alpha). The Aberdeen Questionnaire had a highly significant correlation (r = 0. 74, P <.0001) with the patients' symptoms and concerns questionnaire, which is evidence of its validity. Patients with varicose veins score lower than United Kingdom norms (P <.001) in the physical domains of the SF-36, indicating worse health. After surgery, the SF-36 scores improved in all 8 domains of health, reaching significance in "Mental Health" (P <.05) and approaching significance in "General Health" (P =.066). The Health Transition Item of the SF-36 and the Aberdeen Questionnaire both showed a highly significant improvement in health (P <.001).
The Aberdeen Questionnaire is a valid measure of quality of life for patients with varicose veins. Persons with varicose veins have a reduced quality of life compared with the general population, and this discrepancy is significantly improved at 6 weeks by operating on them.
Some measure of disease severity is needed to properly compare the outcomes of the various approaches to the treatment of chronic venous insufficiency. Comparing the outcomes of two or more different treatments in a clinical trial, or the same treatment in two or more reports from the literature cannot be done with confidence unless the relative severity of the venous disease in each treatment group is known. The CEAP (Clinical-Etiology-Anatomic-Pathophysiologic) system is an excellent classification scheme, but it cannot serve the purpose of venous severity scoring because many of its components are relatively static and others use detailed alphabetical designations. A disease severity scoring scheme needs to be quantifiable, with gradable elements that can change in response to treatment. However, an American Venous Forum committee on venous outcomes assessment has developed a venous severity scoring system based on the best usable elements of the CEAP system. Two scores are proposed. The first is a Venous Clinical Severity Score: nine clinical characteristics of chronic venous disease are graded from 0 to 3 (absent, mild, moderate, severe) with specific criteria to avoid overlap or arbitrary scoring. Zero to three points are added for differences in background conservative therapy (compression and elevation) to produce a 30 point-maximum flat scale. The second is a Venous Segmental Disease Score, which combines the Anatomic and Pathophysiologic components of CEAP. Major venous segments are graded according to presence of reflux and/or obstruction. It is entirely based on venous imaging, primarily duplex scan but also phlebographic findings. This scoring scheme weights 11 venous segments for their relative importance when involved with reflux and/or obstruction, with a maximum score of 10. A third score is simply a modification of the existing CEAP disability score that eliminates reference to work and an 8-hour working day, substituting instead the patient's prior normal activities. These new scoring schemes are intended to complement the current CEAP system.
This prospective study was designed to determine the prevalence of deep reflux and the conditions under which it may occur in patients with primary superficial venous reflux and absence of deep venous thrombosis (DVT).
We studied 152 limbs in 120 consecutive patients in the standing position who had superficial venous reflux with color flow duplex scanning. Limbs with documented evidence of DVT or post-thrombotic vein wall changes during the examination were studied but not included in the analysis. Limbs were divided into those that had at least reflux in the saphenofemoral, the saphenopopliteal, or the gastropopliteal junction and into those with nonjunctional reflux in the superficial and gastrocnemial veins. Peak velocity and duration of reflux were measured. To examine the recirculation theory, we tested the deep veins by occluding and refluxing saphenous veins 10 cm below the sampling site.
Thirteen limbs in 11 patients (9%) were excluded because of previous DVT. Of the remaining 139 limbs, 106 (76%) had junctional reflux. Saphenofemoral junction was involved in 89 limbs (84%), saphenopopliteal junction in 18 (17%), and gastropopliteal junction in 7 (4%). In 33 limbs (24%), reflux was detected in the main trunk or tributaries of the saphenous veins alone with no junctional incompetence. Femoral or popliteal reflux was present in 31 limbs (22%). This reflux was segmental in 27 limbs, and it was limited in the junction in 24 limbs. The mean duration of deep venous reflux was 0.9 seconds, it ranged from 0.6 to 3.7 seconds, and it was significantly shorter than that in the superficial veins (2.6 seconds; P <.0001). In the absence of junctional reflux, the prevalence of deep venous insufficiency (DVI) was significantly lower compared with that in limbs with junctional involvement (2 of 33 vs 29 of 106; P =.038). The mean duration of deep venous reflux in these groups was comparable (0.85 seconds vs 0. 91 seconds; P =.44). Occlusion of the incompetent superficial veins reduced somewhat the duration of the deep venous reflux but did not abolish it (0.88 seconds vs 0.82 seconds; P =.072). The presence of DVI was associated with junctional reflux of high peak velocity and long duration.
The prevalence of DVI in patients with primary superficial venous reflux and without history of DVT is 22%. However, this reflux is segmental, mainly in the common femoral vein, and is of short duration. It is associated with the presence of junctional incompetence that has a high peak velocity and long duration. These findings may explain why surgical correction of superficial reflux abolishes DVI.
Previous work from this group has demonstrated the relationships between lower limb symptoms and the presence and severity of trunk varicose veins as seen on clinical examination to be generally weak, symptom specific, and gender dependent.
This study was undertaken to investigate the relationships in the general population between lower limb symptoms and the presence of superficial or deep venous reflux.
A cross-sectional study was made of an age-stratified random sample of 1566 subjects (699 men and 867 women) aged 18 to 64 selected from 12 general practices in Edinburgh, Scotland. Subjects completed a self-administered questionnaire regarding symptoms (heaviness/tension, a feeling of swelling, aching, restless legs, cramps, itching, tingling) and underwent duplex ultrasound examination of the superficial and deep venous systems of both legs. Reflux of 0.5 seconds or greater was considered pathologic. Deep venous reflux was defined as reflux in at least the popliteal vein.
There was a significant positive relationship between isolated superficial reflux and the presence of heaviness/tension (P <.025, both legs) and itching (P =.002, left leg) in women. Isolated superficial reflux in men was not significantly positively associated with any symptom. Isolated deep venous reflux was not significantly related to any symptom in either leg in either sex. Combined reflux was related to a feeling of swelling (P =.018, right leg; P =.0022, left leg), cramps (P =.0049, left leg) and itching (P =.0043, left leg) in men, and aching (P =.03, right leg) and cramps (P =.026, left leg) in women.
In the general population, only certain lower limb symptoms were related to the presence of reflux on duplex ultrasound scanning. The strongest relationships were observed in the left legs of men with combined superficial and deep reflux.
several studies have used duplex ultrasound to assess valvular incompetence in symptomatic patients. This cross-sectional survey was performed to determine, for the first time in a general population sample, the relationship between trunk varices and the presence of reflux in lower limb venous segments.
1238 subjects (554 male, 684 female), aged 18-64 years, were randomly selected. The presence and severity of any trunk varices was assessed and classified into Grades 1-3; hyphenweb and reticular varices were noted. The presence or absence of reflux > or = 0.5 s in five deep and three superficial venous segments in each leg was assessed using duplex ultrasound.
the prevalence of reflux increased in both superficial and deep segments with more severe grades of trunk varices (p< or = 0.01), except the upper SFV in women. Fifteen per cent of females showed reflux confined to the superficial system, compared with 9% of males (p< or = 0.001); 22% of males showed deep reflux, compared with 11% of females (p < or = 0.001). 71% of men and 48% of women with Grade 2-3 trunk varices had mixed deep and superficial reflux. Above-knee popliteal segments had a higher prevalence of reflux than lower SFV segments in all groups. There was no consistent relationship between the presence of hyphenweb or reticular varices and deep or superficial reflux.
segmental venous reflux can be detected in the deep and superficial leg veins of subjects without trunk varices, but superficial and mixed reflux are increasingly found in subjects with more severe varices.
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.
This study assessed the impact of varicose veins (VV) on quality of life (QOL) and patient-reported symptoms.
A cross-sectional population-based study was held in 166 general practices and 116 specialist clinics for venous disorders of the leg in Belgium, Canada (Quebec), France, and Italy. Study subjects included a sample of 259 reference patients without VV (CEAP class 0 or 1) and 1054 patients with VV who were classified as having VV alone (367; 34.8%), VV with edema (125; 11.9%), VV with skin changes (431; 40.9%), VV with healed ulcer (100; 9.5%), and VV with active ulcer (31; 2.9%). The main outcome measure was generic and disease-specific QOL, as measured by means of the Short-Form Health Survey-36 (SF-36) and the VEINES-QOL scale, and patient-reported symptoms as measured by the VEINES-SYM scale.
In patients with VV, age-standardized mean SF-36 physical (PCS) and mental (MCS) scores were 45.6 and 46.1 in men and 44.2 and 43.2 in women, respectively, compared with population norms of 50. PCS scores decreased according to increasing severity of concomitant venous disease, with the lowest mean scores of 37.3 and 35.5 found in patients with VV and active ulcer. However, adjusted analyses showed no statistically significant differences between patients with VV alone and patients without VV for PCS (0.0), MCS (1.0), VEINES-QOL (-0.1), or VEINES-SYM (0.0) scores. In comparison with patients without VV, the largest differences were seen in patients with VV and edema (PCS, VEINES-QOL, and VEINES-SYM score differences of -1.8, -2.5, and -2.9, respectively) and in patients with VV and ulceration (differences of -3.3, -3.4, and -2.7, respectively). The high prevalence of major symptoms of venous disorders in patients in CEAP class 0 or 1 being treated for venous disorders (76.1% of patients had heaviness, aching legs, or swelling) might have contributed to the impairment of QOL in the reference group.
Results indicate that impairment in physical QOL in patients with VV is associated with concomitant venous disease, rather than the presence of VV per se. Findings concerning QOL in patients with VV can only be reliably interpreted when concomitant venous disease is taken into account. In patients with VV alone, the objectives of cosmetic improvement and the improvement of QOL should be considered separately.
To facilitate study of the natural history and management of venous disease, a 10-component venous clinical severity (VCS) score has been proposed as an objective measure of disease severity. The purpose of this study was to evaluate the validity and reliability of this instrument.
VCS component scores (0 to 3) for pain, varicose veins, edema, pigmentation, inflammation, induration, stocking use, and ulcer size, duration, and number were measured in consecutive patients with chronic venous disease. Differences between observers (n = 3) and on serial evaluation by the same observer were determined.
One hundred twenty-eight limbs in 64 patients were evaluated. Mean VCS score increased from CEAP class 0 (1.7 +/- 1.8) to class 6 (14.7 +/- 3.0; R =.84; P <.0001). Scores in 68 limbs evaluated twice by the same observer differed by a mean of only 0.8 (P =.15), with a reliability coefficient of 0.6. Mean scores of 8.0 (+/- 5.1), 7.2 (+/- 5.1), and 8.0 (+/- 5.4) were obtained in 63 limbs evaluated by all three investigators (P =.02). Only the component scores for pain, inflammation, and pigmentation showed significant (P <.05) interobserver variability. Interobserver agreement on the absence of disease or presence of severe disease as defined by scores of 3 or less or 8 or more was good (kappa = 0.59 and 0.65, respectively).
The VCS score is a critically needed tool for evaluating changes in venous disease over time. The score is reliable and shows good correlation with CEAP clinical classification.
The CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical classification for chronic venous disease (CVD) is based on physician-evaluated clinical signs of CVD. The relationship between CEAP clinical classification and patient-perceived quality of life (QOL) has not been evaluated, but is important for the selection and interpretation of outcomes in clinical studies of patients with CVD. The purpose of this study was to evaluate whether CVD, as classified with CEAP, is related to patient-reported QOL, and to identify patient characteristics associated with CEAP class and QOL that need to be considered when interpreting outcomes in CVD.
The Venous Insufficiency Epidemiologic and Economic Study (VEINES) population is an international cohort of 1531 patients with CVD recruited in Belgium, France, Italy, and Canada. At the baseline visit patients were categorized into one of seven CEAP clinical categories on the basis of a clinical examination, and completed standardized generic (Short-Form Health Survey, 36 items [SF-36]) and venous disease-specific (QOL [VEINES-QOL] and symptom severity [VEINES-Sym]) QOL questionnaires. Multivariate analyses were used to examine the relationship between CEAP class and QOL.
The proportion of patients in the seven CEAP classes (class 0-6) was 3.8%, 13.3%, 24.1%, 12.8%, 36.4%, 7.3%, and 2.3%, respectively. In univariate analyses, SF-36 Physical Component Summary scores and VEINES-QOL and VEINES-Sym scores decreased significantly (ie, poorer QOL) with increasing CEAP class. Multivariate analyses controlling for age, sex, country, education, body mass index, years since CVD onset and comorbid conditions confirmed findings for VEINES-QOL and VEINES-Sym (P<.0001 and P<.0001, respectively).
Physician-evaluated clinical category, based on the CEAP classification, predicts patient-reported QOL and symptom severity in CVD.