Introduction

Chronic venous disease (CVD) is defined as any long-term morphological and functional abnormalities of the venous system with signs or symptoms that require investigation or care¹. CVD is one of the most commonly reported chronic medical conditions and a substantial source of morbidity in the Western world; it affects more than 25 million adults in the United States, 6 million of whom experience more advanced venous disease². Although CVD remains a non-lethal condition, the total number of people affected and the associated management costs make it a major public health issue³. However, its quality of life (QoL) impact is often underestimated, causing discomfort and disability, necessitating leave from work for medical consultations, or emergency care visits.

The clinical, etiological, anatomical, and pathophysiological (CEAP) classification⁴ allows the accurate determination of moderate (varicose veins and edema) and severe (cutaneous dystrophy and ulcer) grades of CVD, but it does not extensively evaluate the clinical symptomatology or measure the impact on patients’ QoL. It is well-known that CVD negatively impacts the well-being of patients, both physical and mental aspects⁵, and there are various QoL questionnaires specific to venous diseases that provide information about patients’ perception of their own health⁶,⁷.

Nevertheless, there is still a paucity of scientific data regarding the impact of CVD on QoL⁸. Estimates of CVD prevalence are subject to significant heterogeneity, as epidemiological studies worldwide vary due to their population, selection criteria, disease definition, and imaging techniques⁹. Gathering demographic data of CVD patients from individual countries are vital for a better understanding of the disease and developing prevention and treatment programs. In Mexico, epidemiological information on CVD is limited, and what is available has been gathered either in regional settings or in specific occupational groups¹⁰,¹¹.

The Vein Consult Program is one of the largest global efforts to raise awareness of CVD among patients, health-care professionals, and health authorities¹². Although Mexico actively participated in recruiting patients and the data collected were included in the final worldwide report¹³, the nationwide results for the Mexican population were never published.

We aim to provide nationally representative epidemiological data on CVD among patients attending routine consultations in general practice and to evaluate the impact on the QoL in this patient population to improve our understanding of the different settings of the disease.

Methods

We reviewed data from a cross-sectional descriptive study carried out in urban and rural areas of Mexico as part of the Vein Consult Program, a global joint initiative between the International Union of Phlebology and Servier Laboratories. The data were collected through opportunistic screening by a selection of general practitioners (GPs), who attempted to enroll patients consecutively during ordinary medical consultations. Those who received a CVD diagnosis were asked to complete the CIVIQ-14 questionnaire. All data collection procedures complied with the ethical standards in the Helsinki Declaration amended in October 2008.

Methodology

Each GP randomly recruited ten or 20 consecutive patients who attended the practice for various medical reasons. In addition to the original reason for consultation, each GP conducted an evaluation defined as step one of the study. For each participant, the GP completed a report assessing the patient’s history, listing any CVD risk factors, screening for CVD symptoms, and performing a routine leg examination. The GP scored the patient according to the C-classification by visual examination. No ultrasound was carried out.

After the evaluation, if the GP diagnosed the patient with CVD, the patient was provided with the CIVIQ-14 questionnaire, asked to complete it at the front desk, and to return it before leaving the office. In addition, at the discretion of the GP, the patient was invited to take part in step two of the study, where they were referred to a vascular specialist for a further clinical evaluation, including a Doppler ultrasound examination. If they did not withdraw, the patient was enrolled in step two upon signing a new written agreement. In all cases, whether or not the patient agreed to participate, their medical care and treatment were not affected. The completed case report forms were collected and provided to the data management and statistics departments. The methodology is represented in figure 1.

Figure 1 Flow diagram of patient evaluation during the Vein Consult trial. GP: General practitioner; CVD: Chronic venous disease; CEAP: clinical, etiological, anatomical, pathophysiological; CIVIQ-14: 14 item chronic venous insufficiency quality of life questionnaire; US: Ultrasound. 

Results

Discussion

CVD epidemiology is important for the creation of specific clinical guidelines for prevention and treatment, as international guidelines may not properly reflect populations of individual countries. This study represents one of the largest recent epidemiological studies focusing on vein disease in the Mexican population. It provides reliable data on the high prevalence of CVD and how the QoL of patients deteriorates as the disease progresses to more severe stages.

Overall, epidemiological studies have demonstrated that CVD is widespread, age-progressive, more commonly encountered in women, and multifactorial in etiologies¹⁴. Beebe-Dimmer et al. reviewed methodologies and results of studies on varicose veins and CVD¹⁵. Overall, estimated prevalence of simple uncomplicated varicose veins ranges dramatically from 2% to 56% in men and <1% to 73% in women. The definition of varicose veins varies among epidemiological investigations, resulting in a range of prevalence estimations. Namely, case definitions may rely on reports of varicose veins by study participants, which may be based on self-diagnosis, recall of a diagnosis by a physician, or a standardized physical examination. The Edinburgh Vein Study, one of the largest studies of venous disease, employed the Basle criteria to categorize varicose veins based on location and severity¹⁶. In a systematic review of global CVD epidemiology, Salim et al. identified 32 studies including over 300,000 adults⁹. The unadjusted and pooled prevalence estimates were as follows: C0_S: 9%, C1: 26%, C2: 19%, C3: 8%, C4: 4%, C5: 1%, and C6: 0.4%. The pooled prevalence of C2 disease was highest in Europe (21%) and lowest in Africa (5.5%), indicating that CVD affects a significant proportion of the population globally, but also that there is significant heterogeneity in existing epidemiological studies. Our results showed a C2 prevalence of 15.8% in Mexico, which could reflect the inclusion of a younger population, compared to the San Diego study, for example, where the average age was over 60 years.

Commonly reported risk factors for CVD include female gender, age, obesity, prolonged standing, CVD-positive family history, and parity¹⁷. However, obesity has not been consistently shown to be a risk factor for CVD. Case-control studies of obesity and CVD are limited in that they do not establish a temporal sequence between exposure and disease. It is possible that CVD and varicose veins may cause patients to be less physically active, making them more prone to becoming overweight. As obesity is associated with a deterioration in joint mobility, this, in turn, can lead to worsening of CVD¹⁸. In this trial, although C0 patients had a lower mean BMI than C1–C6 patients (26.49 ± 4.62 kg/m² versus 28.26 ± 5.11 kg/m²), both groups were still overweight. However, the QoL was lower in the obese group (BMI > 30 kg/m²).

One surprising observation in this study was that the rate of referral to vascular specialists was low. A 2013 survey of GPs in the UK indicated that under 50% were aware of referral guidelines for CVD patients and would refer patients with moderate to severe disease (C4 or C5) to a vein specialist. In addition, only about 10% were aware of clinical venous scoring systems¹⁹. These findings indicate that for CVD patients of all severities to receive the treatment specified by international guidelines, a substantial knowledge gap needs to be bridged²⁰. In this study, only 16.8% of patients with CVD were considered for a referral to a vein specialist, even some with higher CEAP classification. Several factors can influence these decisions; some health-care providers do not authorize referrals to specialists for patients in the lower CEAP categories unless they are very symptomatic, and many patients cannot afford to lose work days if they are only mildly symptomatic, or only consider their condition to be a cosmetic problem.

Of the 924 patients eligible for step two of the study, which involved referral to a vascular specialist, only 172 (18.6 %) consulted the specialist. In this trial, there was no follow-up regarding the reasons behind the low compliance with referrals to vascular specialists, but the accessibility of specialist care has long been debated²¹. The wait for access to specialists has a significant impact on patients, with longer delays increasing stress, anxiety, and pain, affecting daily activities and sometimes leading to deterioration in health. Delayed access to specialist care can also result in diagnostic delays, repetition of tests and services, dissatisfaction among patients and providers, and rising costs²¹; this was also observed in this study, with only 162 patients having a Doppler ultrasound performed. Lack of early treatment can lead to disease progression and the development of skin lesions, such as lipodermatosclerosis and venous leg ulcers. Even before escalation to ulcers, there is still a significant disease burden from chronic venous disorders, such as pain or edema⁸. Although opinions on the need for the early treatment are highly divided, early treatment of these conditions can reduce the risk of escalation and help improve QoL. The low compliance of patients in this study may reflect their perceived minimization of the potential severity of the disease, as it can lead to missed work days. In addition, CVD was not the reason for their initial medical consultations.

Current guidelines and scientific publications tend to focus on clinical and physiological aspects of CVD, as opposed to its impact on patients’ QoL²²,²³. In the present study, CIVIQ-14 scores represented a progressive reduction of QoL from C0s to C6, although this work did not separately compare each section of the questionnaire, such as pain and physical or psychological effects. Radak et al. observed progressive impairment of QoL that primarily involved pain and physical limitations in older patients and women⁷. Similarly, the results of the RELIEF trial also showed that age had a significant effect on global scores, but not on psychological scores²⁴. It is reasonable to infer that the emotional effect of CVD is greater in younger people than in older people, and especially higher in women²⁵, as a significant emphasis is placed on appearance for them.

One important factor that has a long-term effect on QoL was the higher prevalence of diabetes and high blood pressure in patients with CVD in this study. Clinical studies have reported the association of CVD with cardiovascular disease and its risk factors, which have a higher prevalence in CVD patients when compared to the general population (17% vs. 8.6%)²⁶. Diabetes and CVD share microvascular ethological afflictions that predispose patients to vascular wall remodeling, impaired blood flow, increased oxidative stress, vascular inflammation, increased vascular permeability, and endothelial dysfunction²⁷. Higher CEAP classes have been associated with a a higher predicted 10-year risk of developing cardiovascular disease. In individuals without cardiovascular disease (n = 9923), CVD was found to be a strong predictor of all-cause death regardless of the concomitant clinical profile and medication¹⁷. The association of CVD with an increased risk of all-cause death was externally validated in the MyoVasc cohort²⁸.

This study had some limitations: there were several missing data; test-retest reproducibility and responsiveness of the CIVIQ-14 were not assessed; and a CVD diagnosis was made by a GP based on symptoms and clinical and visible changes, rather than on a functional basis and not confirmed by a specialist in most cases, due to the very low compliance of patients with referrals. Available data from those who were evaluated by a specialist were too limited for proper statistical analysis. The CEAP classification, although useful as an objective parameter, does not consider the severity of a patient’s different symptoms. In addition, classification was only done through the clinical evaluation “C,” and the updated classification⁴ was not used.

Conclusion

This study provides reliable data showing that CVD is highly prevalent among patients seen at primary care clinics in Mexico, especially in women, and is not limited to elderly patients, as it was detected even in younger age groups. CVD affects QoL as it progresses, underlining the importance of adequate screening for CVD and additional training for GPs to improve the rates of early referral to vascular specialists. The data generated can be the foundation for proper prevention and treatment programs specifically targeting high-risk populations.