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b ESVS Guidelines Committee: Philippe Kolh (Chair) (Belgium), Gert Jan de Borst (Co-Chair) (Netherlands), Nabil Chakfé (France), Sebastian Debus (Germany), Rob Hinchliffe (United Kingdom), Igor Koncar (Serbia), Jes Lindholt (Denmark), Melina Vega de Ceniga (Spain), Frank Vermassen (Belgium), Fabio Verzini (Italy).
ESVS Guidelines Committee
Footnotes
b ESVS Guidelines Committee: Philippe Kolh (Chair) (Belgium), Gert Jan de Borst (Co-Chair) (Netherlands), Nabil Chakfé (France), Sebastian Debus (Germany), Rob Hinchliffe (United Kingdom), Igor Koncar (Serbia), Jes Lindholt (Denmark), Melina Vega de Ceniga (Spain), Frank Vermassen (Belgium), Fabio Verzini (Italy).
c Document Reviewers: Marianne De Maeseneer (Review Coordinator) (Belgium), Lena Blomgren (Sweden), Olivier Hartung (France), Evi Kalodiki (United Kingdom), Eunice Korten (Netherlands), Marzia Lugli (Italy), Ross Naylor (United Kingdom), Philippe Nicolini (France), Antonio Rosales (Norway).
Document Reviewers
Footnotes
c Document Reviewers: Marianne De Maeseneer (Review Coordinator) (Belgium), Lena Blomgren (Sweden), Olivier Hartung (France), Evi Kalodiki (United Kingdom), Eunice Korten (Netherlands), Marzia Lugli (Italy), Ross Naylor (United Kingdom), Philippe Nicolini (France), Antonio Rosales (Norway).
a Writing Committee: Cees Wittens (Netherlands), Chair; Alun Davies (United Kingdom), Co-Chair; Niels Bækgaard (Denmark); Rikke Broholm (Denmark); Attilio Cavezzi (Italy); Sylvain Chastanet (France); Mark de Wolf (Netherlands); Céline Eggen (Netherlands); Athanasios Giannoukas (Greece); Manjit Gohel (United Kingdom); Stavros Kakkos (Greece/United Kingdom); James Lawson (Netherlands); Thomas Noppeney (Germany); Sarah Onida (United Kingdom); Paul Pittaluga (France); Sarah Thomis (Belgium); Irwin Toonder (Netherlands); Marc Vuylsteke (Belgium). b ESVS Guidelines Committee: Philippe Kolh (Chair) (Belgium), Gert Jan de Borst (Co-Chair) (Netherlands), Nabil Chakfé (France), Sebastian Debus (Germany), Rob Hinchliffe (United Kingdom), Igor Koncar (Serbia), Jes Lindholt (Denmark), Melina Vega de Ceniga (Spain), Frank Vermassen (Belgium), Fabio Verzini (Italy). c Document Reviewers: Marianne De Maeseneer (Review Coordinator) (Belgium), Lena Blomgren (Sweden), Olivier Hartung (France), Evi Kalodiki (United Kingdom), Eunice Korten (Netherlands), Marzia Lugli (Italy), Ross Naylor (United Kingdom), Philippe Nicolini (France), Antonio Rosales (Norway).
Ambulatory Selective Varices Ablation under Local anaesthesia
AVMs
ArterioVenous Malformations
AVP
Ambulatory Venous Pressure
AVVQ
Aberdeen Varicose Veins Questionnaire
BMI
Body Mass Index
CEAP
Clinical Etiologic Anatomic Pathophysiological
CHIVA
Conservatrice et Hémodynamique de l’Insuffisance Veineuse en Ambulatoire
CIVIQ
ChronIc Venous Insufficiency Questionnaire
CT
Computed Tomography
CTV
Computed Tomography Venography
CVD
Chronic Venous Disease
CVI
Chronic Venous Insufficiency
CVMs
Congenital Vascular Malformations
CW
Continuous Wave
DUS
Duplex UltraSound
DVT
Deep Venous Thrombosis
EBM
Evidence Based Medicine
ESVS
European Society for Vascular Surgery
EVLA
EndoVenous Laser Ablation
EVTA
EndoVenous Thermal Ablation
GSV
Great Saphenous Vein
GWC
Guideline Writing Committee
HCSE
Horse CheStnut Extract
HL
High Ligation
HL/S
High Ligation/Stripping
IPC
Intermittent Pneumatic Compression
ISSVA
International Society for the Study of Vascular Anomalies
IVC
Inferior Vena Cava
IVUS
IntraVascular UltraSound
KTS
Klippel-Trenaunay Syndrome
LMWH
Low Molecular Weight Heparin
MOCA
Mechanochemical ablation
MPFF
Micronized Purified Flavonoid Fraction
MR
Magnetic Resonance
MRV
Magnetic Resonance Venography
NIVL
Non-thrombotic Iliac Vein Lesions
OR
Odds Ratio
PASV
Posterior Accessory Saphenous Vein
PTA
Percutaneous Transluminal Angioplasty
PTS
Post Thrombotic Syndrome
PWS
Parkes-Weber Syndrome
QALYs
Quality-Adjusted Life Years
QoL
Quality of Life
RCT(s)
Randomized Controlled Trial(s)
REVAS
REcurrent Varices After Surgery
RFA
RadioFrequency Ablation
SEPS
Subfascial Endoscopic Perforator Surgery
SFJ
SaphenoFemoral Junction
SPJ
SaphenoPopliteal Junction
SSV
Small Saphenous Vein
STS
Sodium Tetradecyl Sulphate
TCL
TransCutaneous Laser
TIPP
TransIlluminated Powered Phlebectomy
UGFS
Ultrasound Guided Foam Sclerotherapy
VCSS
Venous Clinical Severity Score
VDS
Venous Disability Score
VEINES
Venous Insufficiency Epidemiological and Economic Study
VMs
Venous Malformations
VSDS
Venous Segmental Disease Score
Introduction
Members of this Guideline Writing Committee (GWC) were selected by the European Society for Vascular Surgery (ESVS) to represent physicians involved in management of patients with chronic venous disease (CVD). The members of the GWC have provided disclosure statements of all relationships that might be perceived as real or potential sources of conflicts of interest. These disclosure forms are kept on file at the headquarters of the ESVS. The GWC report received neither financial support nor support from the ESVS or any pharmaceutical, device, or surgical industry.
The ESVS guideline committee was responsible for the endorsement process of this guideline. All experts involved in the GWC have approved the final document. The guideline document was reviewed and approved by the EJVES editorial board and ESVS guideline committee.
The Purpose of these Guidelines
The ESVS has developed clinical practice guidelines for the care of patients with CVD in the lower extremities.
The aim of this document is to assist physicians in selecting the best management strategy for patients with CVD. This guideline, established by members of the GWC, who are members of the ESVS or non-members with specific expertise in the field, is based on scientific evidence completed with expert opinion on the matter. By summarizing and evaluating all available evidence in the field, recommendations for the evaluation and treatment of patients with CVD have been formulated.
Guidelines have the purpose of promoting a standard of care according to specialists in the field, in this case represented by members of the ESVS. However, under no circumstance should this guideline be seen as the legal standard of care in all patients. As the word guideline states in itself, the document is a guiding principle, but the care given to a single patient is always dependent on the individual patient (symptom variability, comorbidities, age, level of activity, etc.), treatment setting (techniques available), and other factors.
The recommendations are valid only at the time of publication, as technology and disease knowledge in this field changes rapidly and expanding recommendations can become outdated. It is an aim of the ESVS to revise the guidelines when important new insights in the evaluation and management of CVD become available.
Methodology
Strategy
The GWC was convened in 2011 at the annual ESVS meeting in Athens. At that meeting the tasks in creating the guideline were evaluated and distributed among the committee members. The final version of the guideline was submitted on December 22, 2014.
Literature search and selection
A clinical librarian performed the literature search for this guideline systematically in PubMed, Embase, Cinahl, and the Cochrane Library up to January 1, 2013. Reference checking and handsearch by the guideline committee members added other relevant literature.
The members of the GWC performed the literature selection based on information provided in the title and abstract of the retrieved studies.
Criteria for search and selection were:
Tabled
1
Language:
English, German, and French
Level of evidence:
Selection of the literature was performed following the pyramid of evidence, with aggregated evidence in the top of the pyramid (systematic reviews, meta-analysis), then randomized controlled trials, then observational studies. Single case reports, animal studies, and in vitro studies in the bottom of the pyramid were excluded, leaving expert opinions at the bottom of the pyramid. The level of evidence per section in the guideline is dependent on the level of evidence available on the specific subject.
Sample size:
If there were large studies available, with a minimum of 15 subjects per research group, only these were included. If not available, smaller studies were also included.
Several relevant articles published after the search date or in another foreign language were included, but only if they were of paramount importance to this guideline.
Weighing the evidence
To define the current guidelines, members of the GWC reviewed and summarized the selected literature. Conclusions were drawn based on the scientific evidence.
The guidelines in this document are based on the European Society of Cardiology grading system. For each recommendation, the letter A, B, or C marks the level of current evidence (Table 1). Weighing the level of evidence and expert opinion, every recommendation is subsequently marked as either class I, IIa, IIb, or III (Table 2). The lower the class number, the more proven is the efficacy and safety of a certain procedure.
Table 1Levels of evidence.
Table 1Levels of evidence.
Table 2Classes of recommendations.
Table 2Classes of recommendations.
Chapter 1: General Considerations
The term CVD has been used to describe both visual and functional manifestations of abnormalities in the peripheral venous system. It can be defined as “(any) morphological and functional abnormalities of the venous system of long duration manifest either by symptoms and/or signs indicating the need for investigation and/or care.”
Although a complete understanding of the pathophysiology of CVD remains elusive, chronic venous hypertension is widely accepted as the predominant cause of advanced venous skin changes and ulceration. A sound understanding of the disease process and its clinical presentations is paramount in assessment and management of the patient with CVD.
1.1 History
1.1.1 Pathophysiology
In ancient times, venous problems were described occasionally. Hippocrates (460–377 before Christ) stated that an upright position was inappropriate for a leg with ulceration, assumingly not knowing the real background at that time. In 1544, a Spanish anatomist, Vassaseus, gave a description of venous valves and their function.
At the beginning of the seventeenth century, Harvey published his contribution to the understanding of the physiology of the venous circulation, and Malpighi demonstrated the existence of capillaries and thereby clarified the final connection in the circulatory system.
The pressure changes caused by thoracoabdominal respiration, enhancing the venous return – “vis a fronte” – to the heart, were described in 1710 by Valsalva.
In 1891, the classical test was invented to differentiate between superficial and deep reflux/retrograde flow by Trendelenburg, and 5 years later a test to verify patency of the deep veins was proposed by Perthes, both tests using compression of the limb.
Four-hundred years later, Celsus performed an avulsion technique with hooks of varicose veins. The French surgeon Pravaz has been given credit for the design of the syringe and needle technique for vascular injection in 1831, and later Pétrequin introduced the method of sclerotherapy for varicose veins. After unsatisfactory results by Smith in 1939, the technique was discredited for many years.
In 1944, Orbach introduced the so called “air-block” technique to avoid dilution of the injected sclerosant and, at the same time, create close contact with the endothelium, which indeed was a step forward and also a precursor towards foam sclerotherapy.
The most used methods have been the external stripping by Mayo and the Babcock method with the intraluminal technique, both at the beginning of the twentieth century, and later pin-stripping by Oesch in 1963.
Elastic stockings were invented in 1930 as a result of the personal experience of Jobst, an engineer, who himself suffered from a venous ulceration. While bathing in his pool, he noticed that his symptoms were less pronounced, coming to the conclusion that the increasing depth of the water was the secret of the “healing” component. Thus, graduated compression stockings were invented.
Balloon dilatation and implantation of stents in the venous system was published for the first time in 1991 by Okrent using ballooning and in 1994 by Semba, who used the more durable stenting technique. Both procedures were used as additional treatments to catheter directed thrombolysis at the ilio-femoral level.
The endovenous procedures for varicose veins were developed in the 1990s as thermal, chemical, and mechanochemical vein ablation for truncal varicose disease but were based on the initial work of electro puncture and cauterizations of varicose veins dating back to the 1960s.
1.2 Epidemiology
Clinical reporting, usually indicated as the C of the CEAP classification (from C0 to C6, see further 2.2.1) makes it possible to report prevalence numbers for each clinical class as well as progression rates through the clinical classes over time and relationship to gender, age, obesity, and other risk factors. The prevalences of CVD differ according to these risk factors. The newest and most comprehensive epidemiologic studies from this century will be presented here. Telangiectasiae (also known as spider veins) (C1) have been reported to affect up to 80% of the population.
The more advanced stages of venous disease, CVI (C3–C6), appear to affect about 5% of the population, with the prevalence of the end stages of CVI (active and healed venous ulcers, C5+C6) estimated at 1–2%.
Several studies have revealed older age as the most important risk factor for varicose veins and CVI. In the San Diego study, older age showed a significant odds ratio (OR) up to 2.42 for varicose veins and up to 4.85 for CVI.
In the Bonn Vein study, the most important risk factor for varicose veins and CVI was older age (OR in the age 70–79 years were 15.9 for varicose veins and 23.3 for CVI).
Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung.
C2 disease is more common in female adults than male adults: 13.9–46.3% females and 11.4–29.3% males based on 50,974 persons with most between 16 and 90 years in the five classical studies from Europe and the USA.
Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung.
Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung.
In the same studies, the influence of gender on C0–C1 is inconclusive. However, it has to be mentioned that in the Edinburgh Vein study, varicose veins (C2) were more common among male subjects in the general population.
Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung.
Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung.
Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung.
Half of the general population in the Bonn Vein study reported venous symptoms, 49.1% of the males and 62.1% of the females, and the prevalence increased with age.
In a recent global collection of prospective epidemiologic data on chronic venous disorder in 91,545 subjects including areas outside Europe and the USA, almost the same observations were made, but on a larger scale. Symptomatic C0 was more frequent in men and C2–C3 more frequent in women, but C4–C6 did not differ between men and women.
Other authors found an association between severe obesity (BMI 40 or more) and increasing limb symptoms without anatomic evidence of venous disease, suggesting that the obesity itself contributed to the venous insufficiency.
Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung.
A cohort study revealed that a family history of hospital treatment for varicose veins was associated with an increased risk of similar treatment among relatives.
Responsible genetic disturbances have not been found to explain the obvious heredity. Genome-wide association studies should be considered to further unravel the genetic basis of venous disease.
For many years, prevalence studies have been based on figures and numbers from the western world. Data from Europe, Latin America, the Middle East, and the Far East are now available in the large scale Vein Consult Program with 91,545 subjects over 18 years of age. C1–C6 involved 63.9% of the subjects. The incidence of C2 was significantly lower in the Middle East, whereas C1 was significantly higher. C5 and C6 were unequally distributed in the regions.
In the Edinburgh Vein study with 1,566 subjects, the aim was to correlate venous reflux with clinical features. Reflux was defined as reversed flow longer than 0.5 seconds. No reflux was found in 36.5% of the patients. One third of the subjects had incompetence limited to the superficial system. The frequency of reflux in both superficial and deep segments increased with the clinical severity of disease. CVI increased with age. Symptoms were strongly related to the severity of CVI.
Pathological reflux was defined as longer than 0.5 seconds. The prevalence of superficial reflux was significantly higher in women, whereas deep venous reflux was significantly higher in men. Both types correlated with progression in C stages, but only superficial reflux showed a marked increase with age.
Bonner Venenstudie der Deutschen Gesellschaft für Phlebologie – epidemiologische Untersuchung zur Frage der Häufigkeit und Ausprägung von chronischen Venenkrankheiten in der städtischen und ländlichen Wohnbevölkerung.
However, this does not reveal the rate of progression from lower to higher C classes. A study including 116 limbs with varicose veins used a second duplex scan a median 19 months after the initial examination in the period waiting for surgery. Approximately one-third of the patients had progression, and in 95% of the patients the changes were noted after 6 months or more.
In the GSV compartment there is usually only one truncal vein. Very rarely (in 1% of patients) the GSV is duplicated, which means two veins are situated in the same saphenous compartment.
A few millimetres distal to the saphenofemoral junction (SFJ), the GSV has a terminal valve, and a few centimetres distal to that valve there is often another valve, called the pre-terminal valve.
Important tributaries (i.e. superficial circumflex iliac, superficial epigastric, and superficial external pudendal veins) join the GSV between these valves. The anterior accessory saphenous vein (AASV) and the posterior accessory saphenous vein (PASV) are frequently present and run parallel to the GSV in the thigh in their own saphenous compartment.
The SSV ascends upwards on the posterior aspect of the calf between the two heads of the gastrocnemius muscle. In the popliteal fossa, the main trunk of the SSV frequently drains into the popliteal vein. Often, a cranial extension of the SSV, called the “thigh extension,” continues upwards and uncommonly the SSV does not drain into the popliteal fossa but instead continues cranially and eventually empties into the femoral vein or the GSV. Veins connecting the GSV and SSV are called “intersaphenous veins.” A particular intersaphenous vein is the Giacomini vein running from the SSV in the popliteal fossa to the GSV.
Perforating veins are variable in arrangement and distribution, and are numerous (more than 100 in each limb). The medial perforating veins are most significant but their role in CVI and venous ulcers is not well defined.
On the dorsum of the foot the deep dorsal digital veins drain into the dorsal metatarsal veins. The dorsalis pedis vein located on the dorsum of the foot becomes the anterior tibial veins at the ankle. The tibioperoneal trunk and the anterior tibial veins join and form the popliteal vein in the popliteal fossa.
The main tributaries of the popliteal vein are the gastrocnemius veins, the tibial veins, and the SSV, although the gastrocnemius veins may join the SSV before joining the popliteal vein. The saphenopopliteal junction (SPJ) is often located within 5 cm of the popliteal skin crease, but this level varies.
The popliteal vein continues in a cephalad direction, and ascends in the adductor canal becoming the femoral vein (the previously used term “superficial femoral vein” has been abandoned).
Approximately 10 cm below the inguinal ligament, the femoral vein joins with the deep femoral vein to form the common femoral vein. The common femoral vein is situated medially to the corresponding artery and it ends at the inguinal ligament. The vein receives the GSV at the SFJ. Both the popliteal and the femoral vein may be duplicated in segments of various lengths.
Above the inguinal ligament the common femoral vein continues as the external iliac vein, and at the junction of the internal and external iliac veins anterior to the sacroiliac joint they form the common iliac vein.
As well as the superficial veins, the deep veins contain valves. The frequency of valves increases from the more proximal veins to the more distal. The calf veins contain numerous valves, whereas the femoral and popliteal veins have only one or two valves.
Comparative study of the distribution of venous valves in the lower extremities of black Africans and Caucasians: pathogenetic correlates of prevalence of primary varicose veins in the two races.
Additional valves are seen, however, in the femoral vein near the junction with the deep femoral vein. The common femoral vein usually contains only one valve. Cranial to the SFJ, there is only one or no valve. In the common iliac vein, valves are practically absent or rudimentary, and valves are absent in the inferior vena cava (IVC).
Comparative study of the distribution of venous valves in the lower extremities of black Africans and Caucasians: pathogenetic correlates of prevalence of primary varicose veins in the two races.
The venous circulation is a low pressure, low velocity, large volume, low resistance vascular system. The primary function of the venous system is to return blood to the heart. Venous return is influenced by the interaction between a central pump (the heart), pressure gradients, the peripheral venous pump, and competent valves in patent veins. In an upright position these factors work together to overcome the hydrostatic pressure induced by gravity, which is quite different in the supine position. Furthermore, the system is characterized by its capacitance, which allows pronounced fluid variations. Finally, the system has an impact on the regulation of body temperature.
In steady state, the venous return equals the cardiac output. The venous system contains at least 60% of total resting blood volume, with half of this being in the post-capillary venules in the lower extremity. About 25% resides in the splanchnic circulation.
Venous system: physiology of the capacitance vessels.
in: Shepherd J.T. Abboud F.M. Geiger S.R. The Cardiovascular System, peripheral circulation and organ blood flow, part I, Handbook of physiology. American Physiological Society,
Bethesda1983: 397-452
Venous system: physiology of the capacitance vessels.
in: Shepherd J.T. Abboud F.M. Geiger S.R. The Cardiovascular System, peripheral circulation and organ blood flow, part I, Handbook of physiology. American Physiological Society,
Bethesda1983: 397-452
An increase in capacitance is normal late in the day after standing or sitting, and almost 20% of normal volunteers will demonstrate valvular dysfunction.
The system has a unique function based on the vein compliance. To maintain an acceptable low positive pressure of 5 mmHg, the veins become flaccid, and the pressure can even be negative with minimal volume. In contrast, a considerable increase in volume will result in only a relatively modest change in pressure. A change in vein shape from elliptic to circular indicates high volume and high pressure. In other words: over a normal pressure range of 5–25 mmHg, volume can change remarkably without affecting either flow or pressure.
In the non-supine situation, gravity exercises a hydrostatic influence on the venous system. The hydrostatic pressure at a given anatomical point is determined by measuring the vertical distance between the heart and the point of interest.
In the upright position, the hydrostatic pressure, measured in a dorsal foot vein, is determined by the blood column between the right atrium and the foot. For example in a person 175 cm tall, the venous pressure at the foot may reach approximately 95 mmHg, with the pressure at the groin being 30–35 mmHg, dependent on the anthropometric shape of the body.
The dynamic pressure is basically caused by propagation of arterial pulsation from the pumping heart. Through pre-capillary arterial vasoconstriction - among other factors - most of the dynamic pressure is decreased, resulting in a pressure of 12–18 mmHg in the venous side of the capillary. The atrial pressure of 4–7 mmHg causes the resulting dynamic pressure gradient to facilitate return of blood to the heart in the supine position. The respiratory influence is positive for venous return. Inspiration creates a negative pressure in the thoracic cavity, creating a kind of “suction” of blood, while increased abdominal pressure during inspiration reduces flow in the abdomen. During expiration the opposite flow pattern is seen. This mechanism is mostly seen in the supine position.
A normal valve can resist a pressure above 300 mmHg, but reflux will occur at a higher pressure. In patients with superficial or deep vein valvular imcompetence reflux develops at a much lower pressure because of valve disease and/or vein dilatation.
In the presence of normal valve function the blood is conducted from the superficial veins to the deep veins through the perforating system. An exception is the perforating veins in the foot, where bidirectional flow is normal.
These pumps act together during walking. Intramuscular pressure can increase up to 200–300 mmHg, creating a pressure three times higher in the muscle veins than in the superficial veins, thus creating a pressure gradient cranially and from the calf.
During relaxation the blood is directed from the superficial veins to the deep veins, with the lowest pressure at this stage. The foot pump is quite different in function with elongation of the plantar veins during walking, thus squeezing the blood antegradely.
Venous tone is managed by the muscle layer in the vein wall. Several mechanisms, such as sympathetic-adrenergic nerve activity, circulating vasoactive substances, and local metabolites will stimulate it.
1.4.6 The venous pump: main transport system in the non-supine position
In an upright position venous return is still influenced by the dynamic effect from the heart. The increase in hydrostatic pressure is the same in both the arteries and veins. Fortunately the potent veno-arterial reflex, activated by the venous dilatation, involves an arteriolar constriction restricting the arterial blood flow by 50%.
Even in a so called relaxed standing position there will be muscle contractions, which will diminish the capillary pressure distally in the extremity. With use of the muscle pumps and the valves, together called the venous pump, the pressure distally will be decreased to approximately 30 mmHg during walking or tiptoe/heel raising manoeuvres. This pressure is called the ambulatory venous pressure (AVP), which can be monitored through a needle in a foot vein. Measuring AVP is potentially meaningful. It has been shown that no ulceration was observed in limbs with AVP less than 30 mmHg, but there was 100% incidence with AVP above 90 mmHg.
The pathophysiology of CVD is characterized by reflux, obstruction, or a combination of both. This results in reduced ability to empty the leg veins efficiently during exercise, which means the AVP remains high and this eventually leads to all the clinical features of venous hypertension. Apart from reflux and obstruction, other underlying factors may compromise adequate venous emptying, such as failure of the calf and foot muscle pump (decreased mobility of the ankle joint and other neuromuscular problems).
Whereas most patients with uncomplicated varicose veins (C2) still have normal venous pressures during ambulation, all those with more advanced stages of CVD progressively develop venous hypertension, characterized by symptoms and signs of CVI (C3–C6). The clinical manifestations of CVI are oedema and skin changes, from hyperpigmentation, eczema, atrophie blanche and lipodermatosclerosis to venous ulcers.
Deep vein valve incompetence will result in minor or no reduction in AVP, and venous obstruction will even elevate the pressure during calf contractions, both representing ambulatory venous hypertension.
Outflow obstruction at ilio-femoral level with or without valvular incompetence in the femoral and/or popliteal vein can lead to venous claudication described as a “bursting” pain while walking, only relieved by rest or even better by elevation. In multilevel post-thrombotic obstruction, the iliac vein lesions are the key pathology as infrainguinal obstructions are better tolerated because of adequate collateralization.
The pathophysiological combination of reflux and obstruction is significantly more common in patients with venous ulceration than in those with less advanced stages of CVD.
Varicose veins contain an increased amount of collagen and decreased number of smooth muscle cells and elastin leading to disorganization of muscle components, disruption of elastic fibres, and fibrosis.
The weakness of the vein wall results in dilatation and enlargement of the valve ring, making the valve unable to work sufficiently, with reflux as the consequence.
The reflux can be axial or segmental. For many years, it has been accepted that this process starts cranially, mainly at the level of the SFJ or SPJ, and from there extends to the main trunks and further to the superficial tributaries. This is the so called “descending” pathophysiological theory. More recent research has proposed a rather multifocal origin of varicose veins, which states that, first, tributaries become dilated and incompetent, and only thereafter the main trunks, and eventually the junctions. This corresponds with the “ascending” theory of varicose vein development.
The pathology in the deep veins is more complex. Acute obstruction occurs in the case of deep vein thrombosis. This is not discussed further in the present guideline. Chronic obstruction, resulting in increase of resistance to blood flow, is mainly caused by post-thrombotic changes consisting of stenosis, occlusion, intraluminal synechia, and increased rigidity of the vein wall, or any combination of these abnormalities.
Valves may be damaged and collaterals will develop at any place parallel to a deep obstruction, and even these can be incompetent. Chronic deep venous incompetence occurs in 80% of cases because of post-thrombotic valvular changes, and in 20% because of primary valvular incompetence.
Ilio-femoral venous occlusion is less likely to recanalize compared with other venous segments. Almost two thirds will remain more or less obstructed with variable collateralization.
Relationship between changes in the deep venous system and the development of the postthrombotic syndrome after an acute episode of lower limb deep vein thrombosis: a one- to six-year follow-up.
Relationship between changes in the deep venous system and the development of the postthrombotic syndrome after an acute episode of lower limb deep vein thrombosis: a one- to six-year follow-up.
The site of residual abnormalities in the leg veins in long-term follow-up after deep vein thrombosis and their relationship to the development of the post-thrombotic syndrome.
Patients present with heaviness, tiredness, itching of the skin, nocturnal cramps, and throbbing and aching of the legs, which is exacerbated by prolonged standing.
These symptoms can interfere with day to day activities and work, particularly in patients who need to stand for prolonged periods of time. Symptoms are worse at the end of the day, and symptomatic relief may be achieved by leg elevation, mobilization, and exercise.
In patients with chronic outflow obstruction, venous claudication may typically occur during walking or climbing stairs.
Superficial veins can thrombose, resulting in painful thrombophlebitis and localized cellulitis. Deep venous thrombosis, particularly if found in the ilio-femoral segment, may lead to the development of venous claudication, a bursting pain affecting the buttocks, thighs, or legs when walking, requiring rest and leg elevation to achieve symptomatic relief.
Uncommonly, bleeding can be a presentation of CVD. This is commonly associated with a traumatized superficial varicosity, but significant bleeding can also arise from an area of ulceration. The resulting blood loss may be profound and even life threatening.
Studies have demonstrated that clinical signs correlate with patterns of venous reflux as identified by duplex ultrasound (DUS) examination. This is true for the superficial venous system (including both great and small saphenous)
There is evidence suggesting that clinical signs of disease also correlate with GSV vein diameter, with increasing diameter being associated with greater disease severity.
Relationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study.
Clinical recurrence of varicose veins may present in a similar fashion to primary superficial venous disease. A multicentre study was performed to assess the presence of recurrence in patients who had undergone previous varicose vein surgery.
the vast majority had recurrence associated with oedema (C3) (70.9%), while 29.1% had skin changes (C4). Varicose veins were present in 24.6% (C2), in 43% two clinical classes were present, and in 24% four classes were present. There was a mixture of C0–C6 classes, from reticular veins and telangiectasiae, to varicose veins, oedema, hyperpigmentation, and ulceration.
2.2 Classification of chronic venous disease
The diverse nature of presenting signs and symptoms of patients with CVD means that objective classification of disease severity presents a significant challenge. Classification of CVD may be performed using clinical, anatomical, haemodynamic, or patient reported criteria. A comprehensive classification system would ideally take into consideration all of these factors.
Dramatic variations and inconsistencies in the assessment of disease severity have made it difficult to interpret and compare published reports in the literature. The challenge of inconsistent reporting and the recognition that there was a need for a uniform, applicable and standardized classification system for venous disease, was the main motivation for the development of classifications, particularly the CEAP classification.
The CEAP classification was published in 1994 by an international ad hoc committee of the American Venous Forum and endorsed by the Society for Vascular Surgery.
Following the meeting, it was published in 26 journals and books and in nine languages, making it a truly universal document in the field of CVD. It was revised in 2004 and is a widely endorsed classification system for clinical papers reporting on CVD (Table 3).
The CEAP classification system was developed to take into account not only clinical (C) aspects of venous disease, but also etiological (E), anatomical (A), and pathophysiological (P) components, enabling a more comprehensive assessment of the severity of venous disease. The CEAP classification system has largely replaced the previous severity tools, allowing a standardized approach to the signs and symptoms of CVD and enabling correlation between different studies and reports. Nonetheless, CEAP has been reported as having moderate inter-observer reproducibility when deciding medical indication for treatment.
Clinical signs form the basis of the clinical component of CEAP, which is scored from 0 (no evidence of venous disease) to 6 (active ulceration). Although increasing C classification is generally considered to represent increasing disease severity, this should not be considered a linear progression or severity score. Unlike the Widmer and Porter classifications, the CEAP classification allows more detail to be recorded. Symptoms of CVD, including aching, pain, tightness, skin irritation, heaviness, and muscle cramps are denoted by the letter S in subscript, for example C2S (symptomatic) or C2A (asymptomatic). Even if skin changes have occurred, a patient may be asymptomatic, for example C5A.
2.2.1.2 Etiological classification: Ec, Ep, Es, En
Assessment and management of CVD varies depending on the underlying etiological process. The CEAP classification recognizes and records three different causative factors: congenital (Ec), primary (Ep), and secondary or post-thrombotic (Es). In cases where no etiology is found, (En) is used.
Congenital factors are present from birth, and are related to disorders in the development of the venous system. Klippel-Trenaunay syndrome (KTS), Parkes-Weber syndrome (PWS), and vascular malformations are examples of congenital anomalies.
Primary venous disease commonly results in superficial venous incompetence, particularly located at the connecting points between deep and superficial veins, SFJ, SPJ, or perforating veins. Incompetence (or reflux) of the superficial venous system may result in venous hypertension and the development of signs and symptoms of CVD.
Secondary venous disease usually occurs as a result of previous deep venous thrombosis, although trauma and intra-abdominal masses may also result in impaired venous drainage and the development of CVD.
2.2.1.3 Anatomical classification: As, Ap, Ad, An
The anatomical classification allows accurate description of the location of venous disease. The classification recognizes superficial (As), perforating (Ap), and deep (Ad) venous systems as the site of venous incompetence.
This can be inferred with the aid of clinical tests and the handheld Doppler probe, but determined much more reliably with DUS examination. Where examination cannot identify the location of venous incompetence, the patient is classified as (An). Superficial disease may affect either the great or small saphenous systems. Clinical examination and DUS imaging can provide detailed information to enable targeted assessment and management planning.
The pathophysiological mechanism for CVD has been defined as reflux (Pr), obstruction (Po), both (Pr/o), or not identified (Pn). In the advanced CEAP classification, the venous system has been described as 18 named (and numbered) venous segments, which could be included in the classification to provide a detailed description of CVD in each leg, in an individual patient. Although the detailed elaboration in the advanced CEAP may seem unnecessarily complex or intimidating, it is the only classification to provide a widely accepted and understandable description of all aspects of CVD.
2.2.1.5 Level of investigation
The diagnostic evaluation of venous disease can be classified as
Level 1: history and examination, with or without handheld Doppler assessment
•
Level 2: non-invasive imaging with colour venous duplex and plethysmography, if available
•
Level 3: invasive or complex imaging, including venography, computerized tomography, or MR imaging.
2.2.1.6 Applying the CEAP
The CEAP classification is widely accepted as the best available (and most widely used) classification system, and should be used by investigators reporting on CVD.
It is important to realize that this is a measure that can be repeated to classify changes in patient's clinical presentation. It should be initialized at the first patient encounter and revised on follow up. Many of the limitations of CEAP have been addressed during revisions, resulting in updated terminology and amended definitions.
However, there are aspects that are not taken into account by this classification system, including mixed arterial/venous disease, venous neuropathy, venous claudication, corona phlebectatica, and obesity.
Relationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study.
Although the CEAP classification provides a descriptive classification tool for patients with CVD, there have been criticisms that it lacks responsiveness in the long term and with repeated evaluation of patients. Three other clinical tools have been described to address some of these criticisms.
2.2.2.1 Venous Clinical Severity Score: measure of severity
The Venous Clinical Severity Score (VCSS) was developed to supplement (rather than replace) the CEAP classification. VCSS offers a broad quantification of the severity of venous disease and is not a detailed descriptive tool for CVD in an individual patient. It takes into account the disease severity, and the degree to which patients are affected by it (Table 4). A total of 10 clinical characteristics are evaluated by a healthcare worker and graded from absent (score 0) to severe (score 3), with a total of 30 points attributable. It was developed to assess the progression of CVD and also to give additional weight to more severe clinical disease (C4–C6).
Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group.
The VCSS provides a more accurate measure of the severity of disease and the effect on the patients' day to day activities. Although it is used as a severity score, it has also been found to be a useful screening tool because of its correlation with severity on imaging.
Validation of Venous Clinical Severity Score (VCSS) with other venous severity assessment tools from the American Venous Forum, National Venous Screening Program.
It has been used and evaluated in different studies, and appears to be appropriate for measuring changes after surgery, although it may not be appropriate in studies investigating the use of stockings, as the scoring system takes this into account.
The VCSS has been employed minus the stocking component (VCSS-S) for example, in the assessment of mechanical suppression of angiogenesis in varicose vein surgery.
Mechanical inhibition of angiogenesis at the saphenofemoral junction in the surgical treatment of varicose veins: early results of a blinded randomized controlled trial.
2.2.2.2 Venous Segmental Disease Score: pathophysiology and anatomy
The Venous Segmental Disease Score (VSDS) takes into account the anatomical and pathophysiological mechanisms involved in the presentation of CVD (Table 5).
VSDS accounts for anatomical location and nature (reflux or obstruction) of venous disease, providing a global assessment of pathophysiological disease severity. It relies on duplex scan assessment of the superficial and deep venous systems and provides a score out of 10 for reflux or obstruction. Although the pathophysiology and abnormal venous segments can be described accurately using the advanced CEAP classification, VSDS attributes different scores to different venous segments to indicate the level of overall impact on venous function.
Table 5Venous Segmental Disease Score (VSDS).
Reflux
Obstruction
½
Small saphenous
1
Great saphenous
1
Great saphenous (if thrombosed from groin to below knee)
Reflux describes all valves in a specific segment as incompetent. Obstruction describes a total occlusion at a point in the investigated segment or a >50% stenosis in at least half the segment. Importantly, traumatic obstruction, ligation, or excision of deep venous segments count as thrombosis. However, the same is not true for superficial veins. Perforator interruption and saphenous ligation/ablation count as a reduction of the reflux score, not as an obstruction score.
VSDS was found to correlate with clinical scores, with the magnitude of reflux correlating with symptom severity.
This evaluates the effect of CVD on daily activities. VDS has been validated against the CEAP as a measure of disease severity, and has been used as a measure of change following venous surgery.
The Villalta-Prandoni Scale was described in the 1990s to classify the severity of post-thrombotic syndrome (PTS), a complication of deep venous thrombosis.
Essentially, the scale consists of five symptoms (patient rated) and six physical signs (clinician rated), with each of the 11 factors scored out of 3 (total score out of 33; Table 7). A score of >14, or the presence of venous ulceration, indicates severe PTS.
The Villalta-Prandoni Scale is specific to the post-thrombotic limb and is a reliable, valid measure of PTS in patients with confirmed deep venous thrombosis (DVT).
It also correlates well with patient perceived health burden and QoL scores. A drawback of this scale is that it does not take into account venous claudication or venous ulcer severity, as the presence of a venous ulcer is given a fixed score irrespective of severity.
Assessment of QoL in patients with CVD is integral to a complete and thorough evaluation of their disease status. Evidence shows that increasing clinical severity correlates strongly with deterioration in QoL measures, both general and disease specific.
Clinical classification systems are in place to assess the severity of CVD. QoL tools are available to assess patient reported outcomes. The ideal QoL tool should be generally applicable to any disease process, irrespective of severity, outcome measures, or geographic location.
The tool should be valid (i.e. measure what is intended), reliable (i.e. provide the same measurements for a single individual despite different conditions), and responsive (i.e. sensitive to assess change e.g. after treatment). Ideally, it should also assess all aspects of QoL, including physical, mental and social wellbeing. A number of global QoL instruments exist; however, they lack sensitivity to changing clinical conditions. Health related measures are used instead. A large number of tools have been developed and are in widespread use. There have been greater efforts to standardize the use of QoL assessments in recent years.
Generic and disease specific instruments measuring health related QoL in patients with CVD are discussed below.
2.3.1 Health related generic tools
2.3.1.1 SF-36, Medical Outcomes Study 36 Item Short Form
The SF-36 form is a widely used, generic QoL assessment tool with both physical and mental domains, providing a global assessment of patient wellbeing (Table 8).
The physical component of this patient completed questionnaire has been shown to correlate with venous disease severity. Studies have shown that all sub-domains of the physical component (physical role, pain, physical functioning, and general health perception) correlate significantly with disease severity as measured by the CEAP classification. This is not true for the mental component, as correlations with vitality
The EuroQoL group is a multinational, multicentre, and multidisciplinary network of researchers dedicated to the measurement of health status. The EuroQol questionnaire was devised in the 1990s with the aim of developing a standardized, simple, and generic measure of health for clinical and economic appraisal.
It consists of a descriptive part, evaluating five dimensions (EuroQol – 5D), and a vertical, visual analogue scale (VAS), recording the respondent's self-rated health (EuroQol – VAS).
Together, the EuroQol, 5D and EuroQoL-VAS, provide a comprehensive measure of health state. This tool is particularly useful for measuring utility or quality-adjusted life years (QALYs; a measure of disease burden), and has been used as a QoL measure in the assessment of patients with symptomatic varicose veins (Table 9).
The Aberdeen Varicose Veins Questionnaire (AVVQ), is a patient completed QoL assessment tool comprising 13 questions with domains including physical symptoms, social effect, and cosmesis (Table 10).
Each question is graded in terms of severity/presence or absence, and the results are collated into the Aberdeen Varicose Veins Symptom Severity Score from 0 to 100, where the higher the score, the worse the QoL.
It was found to be reliable, with significant association with patient symptoms. Many consider the responsiveness and sensitivity of the AVVQ to be greater than generic QoL questionnaires. However, generic QoL tools allow simpler calculation of health utility (QALYs), which is a necessity for meaningful health economy comparisons.
Developed in 1996 in France, the Chronic Venous Insufficiency Questionnaire (CIVIQ) is a 20-item self reporting QoL tool covering four dimensions: physical, psychological, social functioning, and pain (Table 11).
In 2010 psychometric validation was carried out, revalidating the questionnaire and providing evidence for its consistency, reliability, and value in assessing changes in QoL after treatment.
2.3.2.3 Venous Insufficiency Epidemiological and Economic study
The Venous Insufficiency Epidemiological and Economic study (VEINES) was an international, prospective cohort study evaluating the epidemiology and outcomes of CVD.
The VEINES study (VEnous Insufficiency Epidemiologic and Economic Study): an international cohort study on chronic venous disorders of the leg. VEINES Group.
Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life.
The aim of this tool was to provide an assessment of QoL and symptoms across the range of conditions in CVD (including telangiectasia, varicose veins, oedema, skin changes, and leg ulcers). Psychometric testing revealed the questionnaire to be acceptable, reliable, and valid in four different language versions, as well as demonstrating correlation with both SF-36 and C class. The VEINES QoL/Sym was also found to be reliable and valid as a measure of QoL and symptoms in patients with acute DVT.
This chapter describes the value of available diagnostic tools used in patients with CVD. It describes the physical examination and additional tests including continuous wave [CW] Doppler, duplex ultrasound [DUS], phlebography, plethysmography, venous pressure measurement, and modern imaging techniques such as magnetic resonance venography [MRV] and computed tomography venography [CTV], as well as describing clinical and radiological diagnostic criteria of recurrent disease.
In the diagnostic work up the nature of the problem and the severity of the disease should be determined.
3.1 Clinical examination
3.1.1 History
Scientific evidence
Patients with varicose veins and/or signs of CVD should be asked, prior to any clinical or diagnostic investigation, about symptoms suggestive of venous pathology.
The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.
This applies also to patients with recurrent varicose veins following intervention, who may present with characteristic symptoms of CVD. Possible thromboembolic antecedents should be investigated, together with any allergy, medication (oral contraceptives primarily), and concomitant relevant diseases including heart and renal failure, which may influence CVD.
The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum.
Patients with CVD are examined in a physiological upright standing position. Both legs should be examined completely. When signs of severe CVD or secondary (e.g. post-thrombotic) varices are present, the abdominal region should be inspected for the possible presence of venous collaterals. Venous collaterals on the lower abdomen, flanks, and pubic region are pathognomonic of iliac or ilio-caval outflow obstruction.
Corona phlebectatica paraplantaris should be noted as this may indicate advanced venous stasis.
In recurrent disease, it is important to bear in mind the patient's pre-operative state and assess any amelioration or worsening in signs such as skin changes or ulceration.
During physical examination, it is important to consider alternative pathology such as signs of arterial insufficiency, orthopaedic, rheumatological, or neurological pathology (muscle pump function). The main circumferences of both legs should be measured when indicated (e.g. phlebolymphedema, suspicion of vascular malformations).
Traditional clinical tests such as Trendelenburg, Perthes, and others have proven unreliable and have no place in the mapping of venous incompetence in general, and of varicose veins in particular.
Distinctions were made between the iliac veins, the femoro-popliteal axis, deep veins in the calf, and superficial and perforating veins. Both normal subjects and patients with known CVD were studied and compared, including the differences between supine and upright examination by DUS.
When the duration of retrograde flow in patients with CVD was compared with healthy subjects, there was a significant (p < .0001) difference for all segments in the affected leg. The cut off values defining venous incompetence (reflux) during ultrasound examination are set at retrograde flow longer than 0.5 s in the superficial venous system, the deep femoral vein, and the calf veins, longer than 1 s in the common femoral, femoral vein, and popliteal vein, and longer than 0.35 s in perforating veins.
Previous international consensus held 0.5 s as a cut off value in all leg vein segments, but this appears to vary with the type of venous segment. The present consensus recommends 1 s as the cut off duration for reflux in femoral and popliteal vein, whereas above 0.5 s is considered reflux in saphenous veins, lower leg veins, and perforators.
The GSV, AASV, PASV, thigh extension, and SSV all situated in their saphenous compartment, are the main superficial conduits to be imaged for morphology and tested for possible reflux, and its segmental distribution.
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