Prevalence and socioeconomic data in chronic venous disease: how useful are they in planning appropriate management?



Dragan J. MILIC,MD, PhD
Clinic for Vascular Surgery – Clinical Center Nis
Nis Medical School – University of Nis
Nis, SERBIA

Prevalence and socioeconomic data in chronic venous disease: how useful are they in planning appropriate management?

by D. J . Milic, Serbia


The exact prevalence of chronic venous disease (CVD) remains difficult to determine because of variations in study population, selection criteria, and disease definition between different studies. The prevalence of CVD, as reported in studies, ranges from 2%-56% in men and from 1%-60% in women. Despite the fact that it has a huge impact on health-care budgets and patients’ quality of life, it is still an underestimated condition. CVD ismore common with increasing age, and in recently published studies there were no significant sex differences. Family history, obesity, prolonged standing, and diet have been proposed as risk factors, but further studies are needed to clarify the influence of potential risk factors on the development of CVD. The financial burden on the health-care system is enormous, with recent estimates placing the cost of CVD treatment at $3 billion per year in the United States, or up to 2% of the total health-care budget of all Western countries. Existing evidence highlights the need for good quality longitudinal and cross-sectional studies measuring the incidence and prevalence of CVD. These studies may help to reduce the magnitude of the problem of CVD by raising awareness among public and health-care authorities, and health-care professionals. Furthermore, prevalence and socioeconomic data may serve as a valuable basis for the planning of appropriate steps to deal with CVD and for the education and hire of skilled personnel.

Medicographia. 2011;33:253-258 (see French abstract on page 258)

Chronic venous disease (CVD) of the lower extremities is one of the most widespread diseases in the populations of Western European countries and the USA. Data from undeveloped countries are scarce, and the true magnitude of the problem is not known. Unfortunately, even in developed Western European countries and the USA, where the problem of CVD is well recognized, the prevalence of CVD is still underestimated by both patients and health-care professionals. This underestimation comes from the fact that chronic venous insufficiency (CVI) is not a lethal condition and that the consequences of this chronic disorder are often overlooked. However, the impact of CVD on patients’ quality of life (QOL) and health-care budgets, especially in the more severe stages, is considerably high. The most common manifestations of CVD are dilated cutaneous veins, such as telangiectasias, reticular veins, and varicose veins. The term “chronic venous insufficiency” describes a condition that affects the venous system of the lower extremities with venous hypertension, causing various pathologies including pain, swelling, edema, skin changes, and ulcerations.

Published studies

Data from available epidemiological literature published during the last 30 years are very difficult to compare due to the fact that different evaluation criteria of CVD were used. Lawrence1 confirms that the prevalence of varicose veins depends on the definition of this disease because dilated veins ranging from telangiectasias to massive varicosities come under the general category of varicose veins. In order to standardize the evaluation of severity of venous disease in 1994, a new classification system was suggested by the American Venous Forum. The CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification system includes not only the clinical symptoms of CVD, but also considers the etiology, anatomic distribution, and the pathogenic mechanisms and produces a score based on the severity of the disease.2 The clinical signs in the affected leg are categorized into seven classes designated C0 to C6. CVD encompasses the full spectrum of signs and symptoms associated with classes C0 to C6, whereas the term “chronic venous insufficiency” is generally restricted to disease of greater severity, such as edema, trophic skin changes (such as pigmentation and lipodermatosclerosis), and ulceration.3

CVD is extremely common, although the prevalence estimates in the literature vary because of differences in the methods of evaluation, criteria for definition, and the geographic regions analyzed.4 In order to establish the magnitude of the problem, epidemiological studies are used to assess the prevalence of diseases or disorders within a population. Cross-sectional studies have usually been used to assess the number of patients with a certain disease within a health-care system. Large random samples have been used to assess populations and have the advantage of including people who selftreat. Prevalence data from such studies are a valuable basis for the planning of appropriate actions to deal with the problem. By repeating a prevalence study within a defined geographical area, we have an opportunity to assess the effect of treatment changes, which is important.5 Unfortunately, published epidemiological studies often misuse prevalence data by mixing overall prevalence figures with point prevalence data, giving an inaccurately wide range that leads to incorrect interpretations of prevalence data between countries and studies. Therefore, in order to provide the most reliable data and to generate accurate comparisons, it is essential to analyze the methods used in various epidemiological studies. However, we still have many pitfalls that can lead to inaccurate conclusions and interpretations6 (Table I).

Table I
Table I. Pitfalls in performing prevalence studies and their effects
on the results.

Abbreviation: CVD, chronic venous disease.

Prevalence data are often harvested from cross-sectional studies or large population samples. The former investigate a defined cohort, generally all patients receiving treatment from health-care professionals within a relatively short time frame, usually one to three months. The latter usually consist of randomly selected people in a certain age range who have not necessarily been in previous contact with the healthcare system. The benefit of population samples is that people who self-treat are included, unlike cross-sectional studies.6 The drawback of a population sample is that usually not all age groups are represented.5

To facilitate recruitment, it is important to avoid approaching carers and patients with lengthy questionnaires. Such forms take time to fill in and introduce a risk of dropout because of lack of time of the carer, patient, or both. A cross-sectional study involves selection bias since only patients treated within the health-care system will be included. Such a study will give an indication of the workload for health-care professionals, but there are, in addition, people who treat the disease on their own. A population sample overcomes this by including all people within the selected sample. The biggest problem of population sample studies is that they need to be fairly large (more than 10 000 people) in order to detect enough patients with the disease so that a reliable prevalence estimate can be made. These studies are expensive, time consuming, and difficult to perform.6

Prevalence of chronic venous insufficiency

The prevalence of varicose veins reported in studies ranges from 2%-56% in men and from 1%-60% in women3 (Table II). Seven general population surveys have been conducted to date,7-13 and only a few studies have measured the incidence of varicose veins. The Framingham Study was a longitudinal study that followed up men and women living in Framingham, USA, over a 16-year period from 1966.14 Every second year over this period, subjects were examined for varicose veins, defined as “the presence of distended and tortuous veins, clearly visible on the lower limbs with the subject standing.” Over the 16-year period, 396 out of the 1720 men and 629 out of the 2012 women who were free from venous disease in 1966 developed varicose veins. On average, the two-year incidence rate of varicose veins was 39.4 per 1000 for men and 51.9 per 1000 for women. However, further studies are required to determine the incidence and progression of venous disease in the general population. One such study is the Edinburgh Vein Follow-Up Study. Subjects examined at baseline in 1994-1996 are currently undergoing a follow-up examination to determine the incidence and natural history of CVD as well as to establish the risk factors relating to progression.

Table II
Table II. Prevalence of varicose veins (%) by sex in studies from
different countries.

After reference 3: Robertson et al. Phlebology. 2008;23:103-111. © 2008, The
Royal Society of Medicine Press.

A cross-sectional study of a random sample of 1566 subjects 18 to 64 years of age from the general population in Edinburgh, Scotland,12 found that telangiectasias and reticular veins were each present in approximately 80% of men and 85% of women. Varicose veins were present in 40% of men and 16% of women, whereas ankle edema was present in 7% of men and 16% of women.12 In this study, duplex ultrasound found reflux in 9.4% of men and 6.6% of women and after age adjustment, reflux rose significantly with age (21.2% in men >50 years old, and 12.0% in women >50 years old).15 Interestingly, it appears that certain treatments can reduce venous reflux. Jantet16 in the RELIEF (Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids) study found that venous reflux was absent in 57% of patients diagnosed as suffering from CVI belonging to CEAP classes C0 to C4. Moreover, during treatment with micronized purified flavonoid fraction, all symptoms showed a decrease in both groups of patients (with and without venous reflux).16

The balance of evidence supports the finding that the prevalence of venous disease increaseswith increasing age.7-9,11,13,17-20 Themagnitude of risk appears to differ depending on the classification criteria, and estimates vary in published studies. The prevalence of varicose veins in men aged 30 to 40 years old is about 3%, while in the age group over 70 years old, it increases up to about 40%.11,13 Similar results were also found in women: a prevalence of 20% at the age of 30 to 40 years old increases gradually with age and by 70 years of age, it exceeds 50%.12 The prevalence of trunk varices rose from 11.5% in persons aged 18 to 24 years old to 55.7% in the population between 55 to 64 years of age.12 The occurrence of skin changes in CVI depends on the patient’s age as well. In the Tecumseh Health Study,7 the prevalence of skin changes in women aged 30 to 39 years old was 1.8%, whereas in patients aged over 70 years old a prevalence of 20.7% was reported.

The San Valentino Vascular Screening Project found a prevalence of 7% for varicose veins and 0.86% for “symptomatic” CVI among the 30 000 subjects evaluated by clinical assessment and duplex ultrasound.21 As in previous studies, CVI was more common with increasing age, but there was no significant sex difference.

Active or healed venous leg ulcers occur in approximately 1% of the general population.12,22 Although not restricted to the elderly, the prevalence of CVD, especially leg ulcers, increases with age.22,23 It has been estimated that 2.5 million people have CVI in the United States, and of those, 20% develop venous ulcers.24 The overall prognosis of venous ulcers is poor with delayed healing and recurrent ulceration.25 More than 50% of venous ulcers require prolonged therapy lasting more than 1 year.26

Most studies have shown that CVI is more prevalent among women, although in a recent study, the difference between sexes was small.4 Selection bias may be a problem in some of these studies, as more women than men may be aware of their varicose veins or consider them to be a problem and, thus, may be more likely to participate in such studies. Moreover, many of the results fromthese studies have not been adjusted for age, a factor that may contribute to the observed gender differences.3 In the Framingham Study,14 the annual incidence of varicose veins was 2.6% among women and 1.9% among men, and in contrast to the Edinburgh Vein Study, the prevalence of varicose veins was higher in men.12 In the San Diego Population Study, CVD was more prevalent in populations of European origin than in blacks or Asians.13 Geographic differences in the prevalence of varicose veins suggest a correlation with race. In particular, the prevalence of CVD has been found to be higher in more developed, industrialized countries than in underdeveloped regions. Mekky et al observed that the prevalence of varicose veins in English women was more than five times as great as that in Egyptian women.27

Risk factors for CVD include heredity, age, female sex, obesity (especially in women), pregnancy, prolonged standing, and greater height.10,28-30

Socioeconomic burden of chronic venous insufficiency The high prevalence of CVI, cost of investigation and treatment, and loss of working days mean that CVD has a considerable socioeconomic impact. The problem is compounded by the fact that CVI is progressive and has a propensity to recur.31 In France, 2.24 billion Euros are spent for the treatment of CVI, of which 41% was for drugs, 34% for hospital care, and 13% for medical fees. In France in 1991, there were 200 000 hospitalizations for CVI (50%were for varicose veins), which was the eighth most common cause of hospitalization. The cost of treatment represented 2.6% of the total healthcare budget for that year.32 In Germany, in-patient direct costs were 250 million Euros, out-patient costs were 234 million Euros, and drug costs were 207 million Euros.33

In Sweden, the average weekly cost of treating venous leg ulcers in 2002 was 101 Euros, with an estimated annual cost of 73 million Euros.34 Indirect costs of venous disease in terms of working days lost were the most important cost factor in 1990 in Germany, amounting to 270 million Euros.33 In the USA, venous ulcers cause the loss of 2 million workdays per year,35 while in France 6.4 million workdays were lost in 1991 due to venous disease.32 The socioeconomic impact of venous ulceration is dramatic, resulting in an impaired ability to engage in social and occupational activities, a reduction in patients’ QOL, and the imposition of financial constraints. In a population study in the United Kingdom, the median duration of ulceration was nine months, but 20% of ulcers had not healed within two years, and ulcer recurrence meant that 66% of patients had episodes of ulceration lasting longer than five years.25 Published data show that venous ulcers may cause the early retirement of a substantial portion, up to 12.5%, of workers with this condition.36

A useful tool to determine the burden of CVI in population is to calculate health expectancies, which are population indicators that estimate the average time (in years) that a person could expect to live in a defined state of health. Health gaps measure the difference between actual population health and some specified norm or goal. The principle characteristic defining a health gap measure is the population norm (age) chosen to define the period before which death or disability is considered premature. Methods for defining health states and for eliciting health state valuations, as well as incorporation of other social values also affect the calculation and interpretation of health gaps, as for health expectancies. The best known of the health gap measures is the disability-adjusted life year (DALY), developed for use in burden of disease studies by Murray and Lopez.37 The DALY combines a measurement of premature mortality and disability and expresses years of life lost to premature death together with years lived with disability of specified severity and duration. One DALY is thus one lost year of healthy life. This indicator is the aggregate of years of life lost (YLL) and years lived with disability (YLD) at a population level, and reflects the burden of disease in a population: DALY = YLL + YLD.

An even more useful tool for assessing the importance of CVI is the quality-adjusted life year (QALY), a measure of disease burden that includes both the quality and the quantity of life lived. It can be used to assess the value for money of a medical intervention. Unfortunately, to date, there are no studies that have assessed DALYs and QALYs in patients with CVI.

Quality of life in patients with chronic venous insufficiency

CVI has a huge impact on patients’ QOL.38,39 Clinical assessment of CVD severity may be carried out using different reported outcome tools: physician reported outcomes (VDS [Venous Disability Score], VCSS [Venous Clinical Severity Score]) and patient reported outcomes, such as QOL scales (generic: SF-12 and SF-36 [Short Form 12 and 36]; or specific: VEINES [VEnous INsufficiency Epidemiological and economic Study], AVVQ [Aberdeen Varicose Veins Questionnaire], CIVIQ [ChronIc Venous dIsease Questionnaire], SQOR-V [Specific Quality Of life Response–Venous]). In the study published by Jantet, patients with venous reflux had lower CIVIQ scores than patients without reflux, reflecting a poorer QOL (62.2 versus 66.7; P=0.0001).16 This was observed not only for the global index scores (GIS), but for all aspects of the CIVIQ (psychological, pain, physical, and social). The subgroup with both short and long saphenous vein involvement had significantly lower QOL scores, and hence poorer QOLs, than the subgroups of patients with isolated reflux of the short saphenous vein or of the long saphenous vein only (GIS = 59.3 versus 64.1 and 64.7, respectively; P=0.0001). It is also interesting to observe from this study that only 21.8% of all patients with CVI were treated for this condition.

The CIVIQ questionnaire is a specific instrument for assessing the impact of venous disease on patients’ QOL. This scale consists of 20 items that assess physical limitation (4 items), physical pain (4 items), social relationships (3 items), and psychological limitations (9 items). The CIVIQ questionnaire uses a Likert response scale, in which each item is scored from 0 to 5. A score per item (a value of 1-5) or a global score (a value of 0-100) can then be calculated. These questionnaires have been successfully used in previous studies.38,40

Conclusion

The exact prevalence of CVD remains difficult to determine because of variations in study population, selection criteria, and disease definition between different studies. The prevalence of varicose veins, as reported in studies, ranges from 2%-56% in men and from 1%-60% in women. Evidence suggests that the prevalence of venous disease increases with age. Varicose veins appear to be more prevalent in women, but pregnancy and the fact that women report the presence of varicose veins more often than men may play a role in this variation. Family history, obesity, prolonged standing, and diet have been proposed as risk factors, but further studies are needed to clarify the influence of potential risk factors on the development of CVI. Existing evidence highlights the need for good quality longitudinal studies measuring the incidence and prevalence of CVD. Varicose veins and CVI are often ignored as an important public health issue even though evidence from research indicates that venous disease affects a significant proportion of the population, causes considerable morbidity, and adversely impacts the QOL of those affected. All of these factors have an influence on health-care budgets and public spending.

Future prevalence and socioeconomic studies may help to reduce the magnitude of the problem of CVI. This type of CVI assessment could raise awareness among the public, healthcare authorities, and health-care professionals. In turn, this could mean that patients in the early stages of CVI receive adequate treatment preventing the development of more severe stages of CVI. Furthermore, prevalence and socioeconomic data may serve as a valuable basis for the planning of appropriate actions to deal with CVD and for the education and hire of skilled personnel. By repeating an epidemiological survey within a defined geographical area, these studies make it possible to assess the effects of treatment protocols. _

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Keywords: chronic venous insufficiency; prevalence; socioeconomic data; chronic venous disease