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Superficial venous insufficiency (SVI) is a major public health problem, affecting millions of people worldwide on every continent. The prevalence of varicose veins is 19%, according to a 2021 meta-analysis of 19 international publications (1). The annual incidence reported by the Edinburgh Vein Stud was 1.4% (2). The onset of these disorders is due to a loss of elasticity of the venous walls and their enlargement as a result of aging, or to lesions of the venous valves. The clinical expression of the condition is highly variable, depending on the veins affected and the degree of venous hypertension generated by blood reflux. In France, according to a survey from IFOP (International Market Research Group), 45% of people report having at least one symptom suggestive of this pathology in 2020. This article presents a worldwide panorama of chronic venous disease. It describes the various existing solutions for treating varicose veins and the latest innovations in non-invasive treatment, in particular HIFU (High-Intensity Focused Ultrasound). This is probably the next disruptive technology in the treatment of varicose veins and venous reflux disease (3).
The Classification of Chronic Venous Insufficiency
Whats is the Chronic Venous Insufficiency?
The Chronic Venous Insufficiency (CVI) is one of the most widespread diseases in the world. It primarily affects the lower limbs. Anatomically, it is defined as a change in the venous wall and/or valvular system of one or more superficial veins. Damage to the venous valves, most often associated with dilatation of the vessel wall, results in valvular incompetence responsible for the blood reflux characteristic of varicose disease. In advanced cases, tissue damage can occur, including œdema and skin lesions that can lead to ulceration.
The variability of the results of the many epidemiological studies available can be explained by the diversity of the classification methods used (4). To standardize the classification of the different forms of CVI, the experts at the American Venous Forum created an objective classification of the condition in 1994, the CEAP.
Understanding the CEAP classification of clinical signs of chronic venous disease
The CEAP classification stands for Clinical (C), Etiological (E), Anatomical (A), and Pathophysiological (P). It aims to aid universally uniform diagnosis and comparison of chronic venous disorders. Revised in 2004 and again in 2020, it is now the worldwide reference for the classification of venous disorders. The consensus of specialists described and classified the different dimensions of chronic venous disease (5, 6), according to :
clinical manifestation ;
etiologic factors ;
anatomic distribution ;
pathophysiologic dysfunction.
The CEAP classification of clinical signs of chronic venous disease
Categories | Clinical signs |
C0 | no visible or palpable signs of venous problems |
C1 | telangiectasias or reticular veins |
C2 | varicose veins |
C2r | recurrent varicose veins |
C3 | œdema |
C4a | pigmentation and/or eczema |
C4b | lipodermatosclerosis (thickening of the skin with a cardboard effect) and/or white atrophy (cutaneous ischaemia) |
C4c | corona phlebectatica |
C5 | healed varicose ulcer |
C6 | non-healed varicose ulcer |
C6r | recurrent varicose ulcer. |
Prevalence of varicose vein problems and regional differences
Chronic venous disease worldwide
The estimated number of patients with type C2 or higher varicose veins worldwide is 731 million, distributed as follows :
168 million in Europe ;
150 million in America ;
412 million in Asia.
The prevalence of varicose veins in Europe
European epidemiological data, based on the CEAP classification (7, 8), show that 27% of the adult population suffer from stage C2 and/or C3 CVI (varicose veins, œdema). Approximately 4% of the population report more severe clinical events C4 to C6 (cutaneous trophic disorders) (Figure 1).
The Edinburgh Vein Study, which followed a cohort of 1456 patients for 13 years, showed an annual incidence of varicose veins of 1.4%CVD (2). A study by Mäkivaara (9) reported an annual incidence rate of CVD of 0.8% in men and 1.9% in women, confirming that the disease is more frequent among women. A study of 610 European women (10) showed that the prevalence of varicose veins was lower (20%) in southern countries (Italy and Spain) than in other countries (29% in Switzerland, France and Central Europe).
Varicose vein disease in France
According to French statistics from INSEE, in 1996, 18 million patients complained of venous circulation problems in the broadest sense, 10 million of whom claimed to have varicose veins. Based on an incidence rate of 1% per year, the estimate was 12 million people in 2016. Venous insufficiency accounts for 2.6% of total healthcare expenditure, highlighting its significant economic impact on Western health systems.
CVD in North America
An American study analysed the prevalence of CVI by ethnic category in San Diego region (11). The White and Hispanic groups had prevalence rates of 20.0 and 22.8%, respectively, while African Americans and Asians had lower rates of 16.4% and 12.5%, respectively. According to the Framingham study (12), the annual increase on varicose veins is higher in North America than in Europe, with an annual increase of 3.9% in men and 5.2% in women.
Varicose veins in Asia
The data from the San Diego study indicate a prevalence of 12.5% for varicose veins in Asia (11).
Varicose vein risk factors
Impact of age and gender on CVD
Age and gender are the main risk factors identified for the development of varicose veins. Hence, Chronic venous disease (CVD) is significantly more prevalent after the age of 55, with women three times more affected than men (sex ratio 3:1) (Figure 2) (4).
However, in this study the authors suspect an underestimate in men, who are less likely to consult their doctor for varicose vein problems.
Pregnancies and CVI
Many studies suggest a strong link between successive pregnancies and the development of varicose veins, such as a study carried out at Tampere Hospital in Finland on 3,590 women aged between 40 and 60 (13).
Secondary risk factors and aggravating factors of varicose
The precise cause of varicose vein formation is unknown, but several risk factors are discussed. Among them, the following can contribute to the development of varicose veins in predisposed individuals :
heredity ;
obesity ;
longer standing time ;
aging ;
contraception ;
slimming diet.
The different techniques of varicose vein treatment
Precise patient information and medical management are always indicated in cases of CVI. There are various techniques for treating varicose veins.
Conservative medical treatments
Elastic compression
Elastic compression exerts pressure on the limb to counter the venous hyperpressure associated with the venous reflux characteristic of CVI. It reduces vein dilation and œdema, and improves calf muscle pumping, microcirculation and lymphatic drainage. It is applied using compression bands or stockings whose elasticity (pressure) varies according to the patient's situation (location and extent of varicose veins). For simple varicose veins, for example, stockings of medium compression class (class 2) are used. In case of severe associated artery disease (arteritis of the lower limbs), compression is contraindicated.
Vasoactive drugs
Vasoactive drugs help limit functional signs and edema, but their effect on the vein wall is limited.
Open surgery
Traditional surgery for varicose veins of the saphenous vein involved a combination of crossectomy (ligation and removal of the saphenofemoral junction) and stripping of the trunk of the great or small saphenous vein, which involves cutting both ends of the diseased vein and removing it by inserting a "stripper". This treatment, generally performed under general anaesthesia, required patients to take 2 to 3 weeks off work. Although effective, this invasive method is no longer recommended due to its morbidity.
Phlebectomy is still proposed for the ablation of superficial saphenous vein tributaries or non-saphenous varicose veins. This treatment is performed as an outpatient procedure under local anaesthesia, either alone or in conjunction with thermal ablation, and generally requires no sick leave.
Other limited surgical procedures under local anaesthetic can be proposed, such as stripping without crossectomy or the CHIVA procedure. The latter consists of a staged ligation of the incontinent saphenous trunk to redirect reflux to the deep venous network.
Thermal ablation of varicose veins
Thermal ablation, which can treat incontinent saphenous veins of any size, has revolutionized the treatment of varicose veins for several years now. It consists in the endovenous destruction of incontinent saphenous trunks through the application of heat, which induces fibrous involution of the vein wall. Obliteration of the treated vein is successful in around 95% of cases at 5 years. Today, this is the first-line treatment recommended by all international guidelines.
The therapeutic procedure requires catheterization of the vein to be treated and local anesthesia via tumescence. It is performed under ultrasound guidance, using a variety of heating technologies:
laser ;
radiofrequency ;
steam ;
microwaves.
Ablation is usually performed in the operating room on an outpatient basis. It is performed alone or in conjunction with phlebectomy or foam sclerotherapy for the treatment of tributary varicose veins (during the same procedure or at a later date). The technique allows immediate return to work.
Non-thermal non tumescent ablation techniques
Sclerotherapy
The technique involves injecting a sclerosing agent into varicose veins, with the aim of obliterating the vein by chemically attacking the vein wall. Originally, liquid sclerosing agents were injected under visual control. Today, however, ultrasound-guided foam sclerotherapy has considerably improved the efficacy and safety of this technique). The foam (a mixture of liquid and air) optimizes contact with the vein wall, considerably enhancing efficacy.Ultrasound guidance allows puncturing safely even invisible and non palpable varicose veinsand precisely analysing foam diffusion into the vein lumen and the occurence of spasm. Sclerotherapy is less effective than thermal ablation to obtain durable obliteration of the treated vein.
Other techniques
Cyanoacrylate glue ablation has been developed to reduce discomfort related to tumescent anesthesia. This technique involves application of cyanoacrylate along the entire length of the saphenous vein to be treated using a dedicated catheter.
Mecano-chemical techniques have been developped in order to improve efficacy of sclerotherapy. They combine mechanical injury of the inner wall of the vein to be treated with simultaneous injection of a liquid or foaming sclerosing agent.
With all these techniques, the catheterisation of the vein to be treated is still required.
Revolutionary solution to treat varicose veins by High-Intensity Focused Ultrasound : HIFU
Among the most recent advances, HIFU (high-intensity focused ultrasound) stands out as a transcutaneous, non-invasive, non-thermal, non-tumescent technique. It uses ultrasound to precisely target the affected veins without the need for any injection nor catheterization.
This varicose veins treatment has been developed by VEINSOUND. The innovation uses ultrasound to obliterate varicose veins by non-thermal cavitation in a transcutaneous way.
Developed in collaboration with the French LabTAU INSERM, this breakthrough technology offers significant benefits for both patients, doctors, and healthcare systems:
fast (Effective for tortuous collateral and saphenous trunk treatments) ;
non-invasive (Extracorporeal procedure, leaving no scars) ;
painless (Ensures maximum patient comfort) ;
no hospitalization (Patients can resume normal activities immediately) ;
safe (Secured by AI features, with no chemical use) ;
convenient (Designed for in-office application) ;
cost-effective (Fully reusable technology) ;
ecologically responsible (no medical waste).
Recommendations and guidelines on treatment strategy for Chronic Venous Disease
In 2022, the European Society of Vascular Surgery updated its 2015 guidelines for the management of chronic venous disease of the lower limbs (14).
A table from these recommendations summarizes the various saphenous trunk treatment techniques with their advantages and limitations.
There are multiple techniques available for the treatment of varicose veins. The choice of procedure depends on many factors, including the size of the veins, the stage of CVI and the patient's preferences. Today, phlebologists and patients alike are increasingly demanding safer, faster, and more effective approaches that provide targeted, non-invasive treatment. Thermal ablation has made a major contribution to the advancement of treatment, but innovative technologies such as HIFU (High-Intensity Focused Ultrasound) are set to revolutionize phlebology.
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