Vol.1/1 – Part I
1
Vol. 1- Suppl. 1 to No 1 – September 2000
Italian College of Phlebology
Guidelines for the diagnosis and treatment of diseases of the veins and lymphatic vessels
Evidence-based report by the Italian College of Phlebology
ACTA PHLEBOLOGICA
Official Journal of the Italian College of Phlebology
Edizioni Minerva Medica
GUIDELINES FOR THE DIAGNOSIS AND THERAPY OF DISEASES OF THE VEINS AND
LYMPHATIC VESSELS
Evidence-based report by the Italian College of Phlebology
2
in collaboration with:
Italian Society of Angiology and Vascular Pathology
Italian Society of Vascular Diagnostics
Italian Society of Vascular and Endovascular Surgery
Italian Society for Microcirculation Research
EDIZIONI MINERVA MEDICA
TORINO
ACTA
PHLEBOLOGICA
OFFICIAL JOURNAL OF THE ITALIAN COLLEGE OF PHLEBOLOGY
Volume 1
September 2000
Suppl. 1 to No. 1
CONTENTS
FOREWORD ................................................................................................................................................ VII
BACKGROUND ............................................................................................................................................. IX
Methods and definitions of the recommendations ........................................................................................... IX
References ....................................................................................................................................................... IX
GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF CHRONIC VENOUS INSUFFICIENCY
Definition ........................................................................................................................................................... 3
Epidemiology..................................................................................................................................................... 3
Classification and categories (CEAP) ............................................................................................................... 4
Non-invasive diagnosis...................................................................................................................................... 6
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VI
Surgical treatment. ............................................................................................................................................. 7
Sclerotherapy. .................................................................................................................................................. 14
Compression. ................................................................................................................................................... 17
Drug therapy. ................................................................................................................................................... 22
Physiotherapy. ................................................................................................................................................. 24
Mineral water therapy ...................................................................................................................................... 24
Treatment of venous ulcers.............................................................................................................................. 25
Venous malformations ..................................................................................................................................... 29
Quality of life (QoL) ........................................................................................................................................ 34
References ....................................................................................................................................................... 35
GUIDELINES FOR THE DIAGNOSIS, PREVENTION AND
TREATMENT OF THROMBOEMBOLISM
Prophylaxis of venous thromboembolism ....................................................................................................... 43
Treatment of deep venous thrombosis (DVT): methods and recommendations ............................................. 51
References ....................................................................................................................................................... 54
GUIDELINES FOR THE DIAGNOSIS AND TREATMENT OF
DISORDERS OF THE LYMPHATIC VESSELS
Lymphatic vessel diseases ............................................................................................................................... 59
Malformations of the lymphatic vessels .......................................................................................................... 64
Quality of life................................................................................................................................................... 65
References ....................................................................................................................................................... 68
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ACTA PHLEBOLOGICA
September 2000
FOREWORD
I have real pleasure in writing this introduction to
in an appropriate context using Anglo-Saxon
the Italian College of Phlebology’s guidelines on
methods which bring everything back to controlled
venous and lymphatic diseases planned and drafted
evidence.
at the start of my presidency. For those of us with a
Intuition,
“Latin” culture, this is the answer to the equation
characteristics of the Mediterranean peoples,
‘clinical approach/controlled feasibility checks’. It
become signposts along the path of diagnosis and
provides us with a means of sharing with our
treatment, obeying international regulations.
tradition,
trade,
and
craft,
all
Colleagues the best, proven information available in
the field today. It is not the “Gospel” for sure, but
only a set of recommendations based on our own
and international research.
While apparently ‘recommendations’ implies the
positive aspects of evidence-based medicine, in
reality it shows how much still remains unproven
and subjective in the field of venous and lymphatic
pathology. To this summary of the state of the art
we must add the incentive for future rigorous,
reliable and reproducible research.
A comparison of these guidelines and those drawn
up by respected international groups shows that we
are not too far from the proven opinions of our
foreign Colleagues – so we are entitled to the
satisfaction of being the professional authors of a
universally agreed text.
However, what distinguishes these guidelines is the
discussion of difficult subjects such as compression
and sclerotherapy. Again, the “Latin” peoples have
long traditions on these subjects, which are now set
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ACTA PHLEBOLOGICA
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VI
recognised the need to unite the main Italian
phlebology societies within the College.
Recommendation: What really holds scientific
associations together is the cultural message borne
in the seed of continuity beyond personal and group
claims and ambitions.
Professor CLAUDIO ALLEGRA
It is exciting that this summary comes from the
Italian College of Phlebology which a few years ago
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ACTA PHLEBOLOGICA
President of the
Italian College of Phlebology
September 2000
VI
BACKGROUND
METHODS AND DEFINITIONS OF THE RECOMMENDATIONS
In Spring 1998, the Italian College of Phlebology set up task forces to prepare guidelines for diagnosis
and treatment in phlebology and lymphangiology. The basic method drew on evidence-based medicine (13), applying the rules of evidence to the medical literature to produce recommendations for clinical
management. Particular consideration was given to the evidence set out in Consensus Statements in this
field (4-11) and the meta-analyses and available randomised trials were used.
We set out to adapt the findings to the working methods and approach taken by the Italian National
Health Service, taking account of the extensive experience of European phlebology, using recent AngloSaxon scientific models.
Therefore, the different levels of recommendations have been classified as A, B and C:
- Grade A, recommendations based on large, randomised clinical trials, or meta-analyses with no
heterogeneity.
- Grade B, recommendations based on randomised clinical trials with small populations, and metaanalyses including non-randomised clinical trials, with some possible heterogeneity.
- Grade C, recommendations based on observational studies and on consensus reached by the authors of
the present guidelines.
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ACTA PHLEBOLOGICA
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VI
REFERENCES
1. Sackett GL et al. Evidence-based medicine: how to practice and teach EBM. London: Churchill
Livingstone, 1996.
2. Greenhalgh T. How to read a paper. The basics of evidence-based medicine. B. M. J. publishing group,
1997 (Ediz. Italiana; Infomedica. Pianezza – TO, 1998).
3. Liberati A. (Ed.), La medicina delle prove di efficacia. Potenzialità e limiti della evidence-based
medicine. Roma: Il Pensiero Scientifico. Ed., 1997
4. Porter JM, Moneta GL and International Consensus Committee on Chronic Venous Disease: reporting
standards in venous disease. J Vasc Surg 1995; 21: 635-45
5. Consensus paper on venous leg ulcers. Phlebology 1991: 7:48-58.
6. Sclerotherapy for varicose veins: practical guidelines and sclerotherapy procedures. Handbook of Venous
Disorders. London: Chapman & Hall. 1996: 337-54
7. Consensus Conference on sclerotherapy on varicose veins of the lower limbs. Phlebology 1997;12: 2 -16.
8. Consensus statement - The investigation of chronic venous insufficiency. Circulation 2000.
9. International Task Force. The management of chronic venous disorders of the leg: an evidence-based
report. Phlebology 1999; 14 (Supplement 1).
10. Consensus Statement. Prevention of venous thromboembolism. Int Angiol 1997 ; 16: 3-38.
11. Consensus Document. The diagnosis and treatment of peripheral lymphedema. Lymphology 1995: 28:
113-7.
VI
ACTA PHLEBOLOGICA
September 2000
ITALIAN COLLEGE OF PHLEBOLOGY
Collegio Italiano di Flebologia
EXECUTIVE
BOARD
P.A. BACCI
President
C. ALLEGRA
O. MALETI
F. MARIANI
A.R. TODINI
Presidents elect
A TORI
G. GENOVESE
S. MANCINI
Information Officer
S. MANDOLESI
General Secretary
G. AZZENA
Honorary Presidents
M. BARTOLO
Associate General Secretary
G. AGUS
Vice-Presidents
M. BALLO
B. BISACCI
G. BROTZU
P. F. CORTESE
General Treasurer
S. CAMILLI
Associate General Treasurer
V. GASBARRO
Advisors
U. BACCAGLINI
I. DONINI
L. MOGGI
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
TASK FORCE:
G.B. Agus, C. Allegra, G. Arpaia, G. Botta, A Cataldi, V. Gasbarro,
S. Mancini.
GUIDELINES FOR THE
In collaboration with:
DIAGNOSIS AND
M. Bartolo jr., G Belcaro, P. Bonadeo, S. Camilli, M. Georgiev, A.
TREATMENT OF
Orsini, F. Stillo, P. Zamboni
CHRONIC VENOUS
INSUFFICIENCY
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September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
its socio-economic repercussions. In the western
DEFINITION
world the consequences of the high prevalence of
Chronic venous insufficiency (CVI) is caused
CVI are well known, the costs of diagnostic
by inadequate function of the peripheral veins. The
procedures
and
treatment
programmes,
the
equilibrium between tissue requirements and the
significant amount of work hours lost and the
amount of blood returning to the heart is not
repercussions on quality of life (1-3).
guaranteed, either in an orthostatic position or lying
The current prevalence of CVI in the lower
down. However, CVI does not simply involve the
limbs is from 10-50% of the adult male population
patency of the veins and the condition of their walls
and 50-55% of the adult female population. Clinical
and valves (vascular factor) but includes any other
signs of varicosis are present in 10-33% of women
cause that might affect venous return, such as
and 10-20% adult men (1, 4-6).
muscle pump action in the feet, calves and thighs or
To give pure data on the incidence of these
changes in joint mobility and connective tissue
diseases, prospective epidemiological studies are
(extravascular factors). A distinction must also be
most interesting from our point of view, although in
made between insufficiency of the superficial
actual fact very few of these focus solely on CVI.
venous system and insufficiency of the deep venous
The most widely cited is the Framingham study,
system, or of both.
which found the incidence of varicose veins (new
The key to recognising the subjective and
cases appearing in each unit of time) was 2.6% in
objective signs of CVI is local or diffuse venous
women and 1.9% in men per year; at two years
hypertension with rheologic repercussions on the
varicose veins affect 39/1000 men and 52/1000
macrocirculation and microcirculation, leading to
women (7). The prevalence of varicose veins in
the characteristic edema.
epidemiological
These signs are valid at
both the physiopathological and clinical levels.
studies
covering
different
geographical areas varies widely (6).
The acquired or congenital pathological process
The correlation between the prevalence of
causing CVI (angiodysplasia, valvular insufficiency
varicose veins and age is almost linear: 7-35% and
or agenesis) can be functional or organic, the latter
20-60% respectively in men and women between
being more common but usually less severe.
the ages of 35 and 40 years up to 15-55% in men
and 40-78% in women over the age of 60. Venous
diseases and varicose veins are rarely seen in
children and adolescents, although children with a
EPIDEMIOLOGY
family history of varicose veins can develop venous
CVI is a serious clinical condition affecting
ectasia and incompetence in their teens (1, 6, 8).
large numbers of people, and is important both from
It is still debated whether the transmission of
an epidemiological point of view and on account of
venous disorders is hereditary. The incidence of
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ACTA PHLEBOLOGICA
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
varicose
veins
in
people
with
or
without
are
overweight,
especially
women
living
in
transmissible hereditary factors varies between 44
developed countries, suffer more from CVI and
and 65% in the presence of these factors as opposed
varicose diseases than people of normal weight:
to 27-53% when these factors are absent (6).
from 25% to over 70% (both sexes) as opposed to
Familial predisposition is found in 85% of people
16-45% (6). Varicose veins appear in both legs in
with varicose veins but only 22% of those with no
39-76% of cases (6).
family history (9).
Although many studies
Hypertension,
cigarette
smoking
and
demonstrate "vertical inheritance" none have yet
constipation have not been shown to be correlated to
shown a “horizontal inheritance” which could be
CVI nor to be statistically significant risk factors for
attributed to a genetic model.
CVI.
CVI mainly affects women in their fifties and
It is widely recognised that certain occupations,
sixties. After this age there is no real difference
particularly those that involve standing for long
between the sexes. Overall, epidemiological studies
periods, are associated with an increased prevalence
give evidence of a male/female ratio of 1:2-3,
of varicose veins; however, it is extremely difficult
although Widmer’s large Basel trial (10) found a
to demonstrate a statistical correlation (4,11).
ratio of 1:1. This is probably due to the different
Studies have focused on the incidence of varicose
trial methods (6).
veins among people in a variety of jobs, particularly
Numerous epidemiological studies correlate the
industrial and several authors have confirmed the
incidence of varicose veins with pregnancies and
association between the upright posture and varicose
with the number of births. This varies between 10
veins (6,12). The temperature of the workplace also
and 63% in women with children as opposed to 4-
has an influence (11).
26% in nulliparous women. Women who have had
Edema and trophic lesions, eczema and
1-5 pregnancies have an incidence of venous disease
hyperpigmentation, all expressions of CVI CEAP
of between 11 and 42%, the proportion rising
categories 4-6, are reported in 3-11% of the
linearly with the number of births. This correlation
population. The development of new symptoms/year
is even more striking if the woman already has
is about 1% for edema and 0.8% for mild skin
venous disorders. However, there is no shortage of
disorders (1). Active venous ulcers (VU) are found
studies disagreeing with this conclusion, which find
in about 0.3% of the adult population in the West
no relationship between the incidence of varicose
and the overall prevalence of active and healed
veins and the number of births (6).
ulcers has been put at 1%, rising to 3% in the over-
The relationship between varicose veins and
70 age bracket.
body weight has been widely examined. People who
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ACTA PHLEBOLOGICA
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
VU seems to be less likely or slower to heal
medications alone), more than one billion dollars in
among patients in the middle-lower social classes.
the United States
($300,000,000 for domiciliary
The prognosis for VU is anyway not good, as they
treatment), 400,000,000 DM in Germany and
take a long time to heal and recur easily; 50-75%
300,000,000 Swedish krona, whilst in France ulcer
take 4-6 months to heal while 20% are still open at
treatments cost an average of 240,000 francs a year
24 months and 8% at five years.
(1). In Italy around 291,000 doctor’s visits/year are
Among patients of working age 12.5% apply for
made for ulcers, with prescriptions in 95% of cases,
early retirement (1,, 2, 13-15). CVI is thus not only
giving a financial burden of 243 billion lira (18). In
a serious burden on the health care services but also
total, the direct and indirect cost of CVI is around
a considerable cost to society (16,17).
one billion dollars for each European state for which
The number of working hours lost through CVI
each year in England and Wales is around 500,000,
recent figures are available (UK, France, Germany)
(1).
whilst in the United States (where 25,000,000
people have varicose veins, 2,500,000 suffer from
CLASSIFICATION AND CATEGORIES
CVI and 500,000 from active venous ulcers) it
(CEAP)
reaches 2,000,000. The Brazilian public health
figures show that, of the fifty illnesses most often
The CEAP classifications were drawn up by an
cited as the reason for absenteeism and normally
international group of specialists in 1994, the aim
acknowledged in compensation schemes, CVI is
being to produce a new, standard method for the
placed 14th as it is the 32nd most frequent cause of
evaluation of chronic venous diseases which
permanent invalidity (1).
encompassed all the signs and symptoms of the
The annual cost of CVI management – almost
disease
(19).
At
the
World
Conference
of
certainly underestimated - is put at GB£290 million,
Phlebology, in London in 1996, these classifications
14.7 billion French francs, 2,420 million German
were reviewed and validated internationally. Since
marks, 1,638 billion Italian lira and 17,240 million
then, they have been translated into a number of
Spanish
languages and the international literature offers
pesetas.
In
addition,
the
European
Community allocates 1.5 – 2% of its entire health
many papers that use these classifications (20-26).
budget – 418-1135 million ECU in 1992 – for the
principal countries in Europe, over and above the
indirect costs due to disability (2,17).
The annual cost of treating VU in the UK
reaches
£400-600,000,000
Vol. 1 – Suppl. 1 to No. 1
(£40,000,000
for
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
CEAP CLASSIFICATIONS
2) Cs6 – Es – As2 – 3 – 5, p11-13, Pr,o
Clinical
CO
no signs of venous disease
Patient with post-phlebitis syndrome with active
C1
teleangectasia or reticular veins
trophic lesions and obstruction of the deep femoral
C2
varicose veins
circulation with incontinence along the whole great
C3
edema without skin changes
saphenous vein.
C4
skin changes (pigmentation, venous
Anatomic scoring: 5
eczema, lipodermatosclerosis)
C5
skin changes with healed ulceration
Disability scoring: 3
C6
skin changes with active ulceration
Clinical scoring:
7
Etiologic
CEAP Classifications
Primary
Secondary
Congenital
-
Clinical
Anatomic
-
Etiologic
Superficial
-
Anatomic
Deep
-
Pathophysiological
Perforator
C = clinical signs (C0-6)
Pathophysiological
Reflux
Obstruction
a = asymptomatic
Both
s = symptomatic
Examples:
E = etiology (Ec, Ep, Es)
1) Cs2 – Ep – As4 – Pr
A = anatomic findings (As, d, p)
Patient with primary varicose veins of the small
saphenous vein with reflux.
P = physiopathology (Pr, o)
Anatomic scoring: 1
Clinical classifications (C 0-6)
Disability scoring: 1
Clinical scoring:
6
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September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
class 0: no visible or palpable clinical signs of
Etiologic classifications (Ec, Ep, Es)
venous disease
class 1: telangiectasia or reticular veins
Ec = congenital (from birth)
class 2: varicose veins
Ep = primary (non-identifiable cause)
class 3: edema
Es = secondary (post-thrombotic,
class
4:
skin
changes
of
venous
origin
post-traumatic, other)
(pigmentation, eczema, subcutaneous inflammation)
class 5: as class 4 with healed ulceration
Anatomic classifications (As,d,p)
class 6: as class 4 with active ulceration
As = involving the superficial veins
Ad = involving the deep veins
Ap = involving the perforating veins
Superficial veins: As
1) telangiectasias, reticular veins on the small vena
saphena
2) above the knee
3) below the knee
4) small saphenous vein
5) non-saphenous venous districts
Deep veins: Ad
6) inferior vena cava/iliac vein
7) common iliac
8) internal iliac
9) external iliac
10) pelvic veins: gonadal, broad ligament, femoral
vein, other
11) common femoral
12) deep femoral
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
13) superficial femoral
2 disabling
14) popliteal vein
15) crural, and leg veins: anterior and posterior
pigmentation
0 none
tibial, peroneal
1 localised
16) muscle veins: gastrocnemius, soleus, etc.
2 extensive
Perforating veins
subcutaneous
0 none
inflammation
1 localised
17) Thigh
2 extensive
18) Calf
ulcer (size)
0 none
1 less than 2 cm
Scoring venous malfunction by severity
2 more than 2 cm
*anatomic scoring: number of parts affected: 1
point for each part affected
*clinical scoring: objective symptoms and signs
pain
0 none
1 moderate, not
requiring treatment
2 severe, requiring
pain killers
edema
0 none
1 moderate, not
requiring treatment
2 extensive
venous claudication
0 none
1 moderate, not
requiring treatment
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
ulcer (duration)
0 none
Non-invasive diagnostic methods for venous
1 less than 3
disease
months
were
developed
for
screening,
for
quantifying lesions, and for hemodynamic studies.
2 more than 3
Centers for non-invasive diagnosis have grown up
months
mainly in the last few decades.
Both the general practitioner and the specialist
ulcer (recurrences)
0 not recurrent
must, with varying degrees of competence, know the
1 only one ulcer
significance of the various vascular tests,
2 recurs after
indications and limitations, so they can avoid having
healing
their
to prescribe unnecessarily invasive and costly tests
(27-29).
ulcer (number)
0 none
Venous disease is more difficult to evaluate
1 one
than arterial disease and requires experience and
2 more than one
closer evaluation. This means venous tests are much
more operator- dependent and require specific
disability score
0 asymptomatic
1
symptoms,
clinical skills, particularly in the evaluation of CVI.
but
CVI can be the result of obstruction to venous
can lead a normal
outflow or return, or to a combination of the two.
life without
Clinical examination and diagnostic techniques
support
hose
therefore aim to establish which conditions are
2 able to work an
present. The anatomical location of the alterations
eight-hour
must be found and the reflux and/or obstruction
only
with
day
support
must be identified.
hose
3
work
There are many simple, rapid and efficient tests
unable
to
available which are cost-effective. Just three types
even
with
of examinations give the basic information usually
support hose
NON-INVASIVE DIAGNOSIS
needed to evaluate and quantify venous problems:
-
continuous-wave (CW) Doppler
-
duplex scan/colour Doppler ultrasound
-
plethysmography
adding, as necessary:
-
Vol. 1 – Suppl. 1 to No. 1
investigation of the microcirculation.
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
EVALUATION OF VENOUS REFLUX
Reflux is usually assessed with the patient
standing, with the limb under examination relaxed
and the knee slightly bent. After the clinical and
physical
examination
the
screening
can
be
completed with a directional pocket Doppler scanner
which gives information about the presence or
absence of reverse flow at the sapheno-femoral and
sapheno-popliteal junctions.
Manual compression
of the calf produces an upward flow in the limb and
reverse flow can be seen when the pressure is
released. Compression must be applied for at least
three seconds, not more than 10-20 cm distally from
the site of examination.
If the reverse flow
disappears on compressing the superficial vein distal
to the junction it is limited to the superficial system.
The CW Doppler gives information on the
presence or absence of reflux at the venous junctions
in 50-90% of patients (Consensus).
Anatomical
anomalies in the popliteal cavity can cause various
errors;
for
gastrocnemius
example,
veins
reverse
may
be
flow
in
interpreted
the
as
incontinence of the popliteal vein. The CW Doppler
is not useful for locating incompetent perforating
veins.
Screening with the CW Doppler can be
completed with a duplex/color flow map (CFM),
giving information on the site of the reflux;
for
example, the femoral vein, the popliteal or the
perforating veins can all be studied individually.
Color testing (CFM) means a faster assessment can
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
be made. Using a 7.5 MHz probe the vein under
cuffs which measure changes in the total venous
examination can be visualised with the patient
volume of the leg (29).
upright. The compression test can then show
By taking measurements in various positions
whether there is reverse flow. A high-resolution
and during various maneuvres it is possible to
probe serves to document the competence of the
evaluate the following:
valve.
CFM is particularly useful for locating
reverse flow in patients with recurrent varicose
veins after surgery or sclerotherapy, or with
- venous outflow (slowed if there is occlusion)
- total venous reflux (degree of valvular
incontinence)
anatomical anomalies. CFM also confirms the
- the efficiency of the muscle pump in the calf
competence of the deep venous system and the
(venous drainage during exercise and the speed of
extent and the site of any deep reflux. Reverse flow
refilling after exercise).
in a single vein can be quantified but this takes
longer.
These measurements can be done as baseline
values, as a basis for assessing overall venous
Some
plethysmographic
techniques
give
accurate and reproducible results.
function or, using a tourniquet to exclude the
superficial veins, to give separate evaluations of the
superficial and deep veins.
VENOUS PLETHYSMOGRAPHY
Venous plethysmography has the following
applications in clinical practice:
Venous plethysmography measures changes in
- to measure and document the degree of
venous blood volume in the legs, to evaluate overall
impairment
of the various venous
functions
venous function. Three plethysmography techniques
(obstruction, reverse flow) and follow them over
are currently in use: photoplethysmography/light
time;
reflection rheography (PPG/LRR), strain gauge
- to measure the involvement of the superficial
plethysmography (extensimetric, SGP), and air
and deep veins and predict the hemodynamic effects
plethysmography (APG) (30, 1, 31).
of superficial vein surgery;
PPG/LLR uses photo sensors attached to the skin
- to study and document the hemodynamic
to measure filling of the cutaneous vein network
effects of different surgical options and validate new
(27).
SGP uses extensimetric sensors (elastic
technics.
sensor
straps)
to
measure
changes
in
the
circumference of the leg at the point where they are
METHODS
applied (28). The APG sensors are inflatable leg
MICROCIRCULATION
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ACTA PHLEBOLOGICA
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INVESTIGATING
THE
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
- Laser-Doppler
- Capillaroscopy
Recommendations:
- Microlymphography
- Interstitial pressure
- O2 and CO2 partial pressure
- After clinical examination, the main screening
method for CVI should be the CW Doppler.
Grade B
- Echo-Doppler and colour echo-Doppler should
be used to establish the location and the
morphology of the problem. Grade A
- Phlebography is only needed for a small number
of patients who have anatomical anomalies, or
malformations, or when surgery on the deep
venous system is indicated. Grade B
- Plethysmography should be considered as an
additional quantitative test. Grade B
- Investigations of the microcirculation are only
indicated in selected patients, mainly for research
purposes. Grade C
SURGICAL TREATMENT
Surgical
treatment
for
superficial
venous
insufficiency
BACKGROUND AND INDICATIONS
Surgical treatment of varicose veins in the
lower limbs started virtually a century ago, with the
work of Mayo and Babcock (32, 33), and is still a
current procedure. Many thousands of operations
and studies have confirmed its value (34-36).
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Essentially,
three
relative
innovations
have
improved the results of the standard surgical
the troublesome problem of varicose veins recurring
and new ones appearing after surgery.
technique: the stripping technique itself has been
The main aim of treating patients with CVI is to
improved, in the light of new anatomical and
cure or improve the symptoms and to prevent or
physiopathological knowledge; simplified surgical
treat complications. The standard treatment for
procedures are now used, such as microsurgical
varicose veins is elevation of the lower limb to a
phlebectomy (37,38) and stripping by invagination
drainage position and elastic compression hosiery to
(39); and pre-operative mapping is done using
control edema, with local medication for ulcers.
colour echo-Doppler tests (40-43).
However, this does not treat the underlying
Many new surgical approaches have been
hemodynamic disorder causing the venous disease.
proposed, some only used by the proponent. These
Significant progress has been made in the
may give good clinical results, but controlled
surgical treatment of severe forms of CVI which can
multicenter trials are needed to assess them. For the
now be diagnosed non-invasively with imaging and
time being, therefore, they cannot be considered
velocimetry methods. It is possible to distinguish
substitutes for the standard techniques; at best they
between situations in which obstruction prevails,
can be considered alternatives.
and others – either primary or secondary – in which
The importance of varicose vein surgery in
reverse flow is dominant.
The surgical strategy
Western health services is shown by the frequency
chosen will depend on the different clinical,
of
are
anatomical and pathological presentations. A wide
100,000
range of strategies is available, no longer restricted
inhabitants in the United Kingdom (44), 200 per
to extensive and indiscriminate ablation, but aimed
100,000 inhabitants in Finland (45), and a much
at correcting, where possible, the venous and
larger number in France (more than 150,000/year
microcirculatory hemodynamic abnormalities in the
(46) and Italy (more than 100,000/year in 1997
limb (47,48).
demand.
calculated
Generally,
at
70
the
requirements
interventions
per
according to an estimate by the DGR, including -
Indications for surgery in CVI depend on the
but probably underestimating - the private sector.
symptoms, and on the objective findings of varices
Therefore,
or
the
surgical
indications
must
be
discussed in depth.
their
complications.
The
symptoms
and
pathologies that motivate the surgical choices are:
The aim of surgery is total removal of all
- clinical presentation and appearance
varicose veins, and this itself must be viewed within
- pain
the context of the underlying pathology - CVI - and
- heaviness of the leg
- fatigue in the limb
Vol. 1 – Suppl. 1 to No. 1
ACTA PHLEBOLOGICA
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
- superficial venous thrombosis
predisposed to CVI because of these factors. In
- bleeding varices
these cases, surgery may even be contraindicated,
- pigmentation at the ankle
and corrective measures may be sufficient to obviate
- lipodermatosclerosis
the need for surgical intervention. Recent studies
- white atrophy
suggest that many symptoms may not be caused by
- ulcers.
venous factors and the venous disorder is simply
However, as the patient himself may not
concomitant with the underlying problem; in cases
attribute several of these signs and symptoms to
such as these surgical intervention is unlikely to
CVI, a thorough, specific case history should be
relieve the symptoms (52,53).
taken.
Fifty percent of patients with telangiectasia
Surgery of the superficial venous system
and varices suffer from some of the disorders listed
accounts for a substantial portion of the workload of
and with suitable treatment these problems will be
a general and vascular surgical unit and is one of the
eliminated in 85% of cases (49).
main reasons why waiting lists tend to be long.
Heaviness of the legs is the most common
There is also the suggestion that “inadequate”
reason for an examination by a venous specialist,
venous surgery is responsible for many cases of
especially among younger women. Recent studies
recurrent varicose veins, even if the surgical
indicate that it may not be caused by a varicose
technique was error-free (54) although it is not clear
state, nor is it necessarily a pre-varicose syndrome.
what
exactly
was
meant
by
It is more likely to be the result of a combination of
constitutional venous stasis, venous hypertension
and lipedema (50,51).
Numerous other diseases give the same
symptoms of fatigue and easy functional exhaustion:
joint, neurological and peripheral arterial diseases
are the most frequently cited. Similarly, edema of
the lower legs is not obligatorily correlated with
CVI, and a differential diagnosis must be made
taking account of congestive cardiopathy, blood
dyscrasia, metabolic disorders, etc. Finally, patients
who have an unhealthy lifestyle, are overweight, do
little exercise, have bad posture and are excessively
sedentary may also have CVI, or actually become
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
adequate
(or
appropriate)
or
inadequate
(or
inappropriate) surgery (55).
- conservative surgery, without excision of the
saphenous trunks
- endovascular treatment
Recommendations:
Ablative surgery
- The aim of varicose vein surgery is to relieve the
This includes stripping along the whole length of the
symptoms, and prevent or treat any complications
greater saphenous vein (from the sapheno-femoral
while recognising that the varicose disorder is
junction
likely to be progressive. Grade A
stripping of the greater saphenous vein (from the
to
the medial malleolus), restricted
sapheno-femoral junction as far as the upper third of
- The surgical patient will require regular follow-
the leg), stripping the small saphenous vein (from
the saphenous-popliteal junction to the lateral
up. Grade A
malleolus or the mid-calf).
and
Ablation of the saphenous veins is usually
which
completed by varicectomy and by section and
therefore do not necessarily call for a surgical
ligature of the incompetent perforating veins so as to
approach. Grade B
achieve the required hemodynamic result by
- There are valid medical alternatives,
sclerotherapy,
for
collateral
veins,
excising the refluxing vessels.
This is the standard surgical treatment. It has
SURGICAL TECHNIQUES FOR VARICOSE
been extensively studied over the years and
VEINS
comparative
studies
have
been
made
with
sclerotherapy and with crossectomy alone or
Nowadays any surgical intervention for superficial
combined with sclerotherapy, but there have been no
venous insufficiency should be preceded by
comparative studies with the alternative surgical
hemodynamic studies using colour echo-Doppler
treatments. However, ablative surgery was more
mapping of the area.
effective than the other two methods (34, 35, 56-62).
The surgical techniques can be classified in four
Several techniques have been described: Babcock’s
main groups:
intravenous stripping; Mayo’s external stripping –
- ablative surgery
and its derivations; stripping by invagination as
- symptomatic ablative surgery
done by Van der Strict, Ouvry, Oesch.
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ACTA PHLEBOLOGICA
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
The patient should be informed that the aim of the
Recommendations:
intervention is to treat the symptoms; when limited
to the specified indications this is currently rated as
Before any decision on which of these techniques is
Grade B.
indicated, a detailed echo-Doppler study should be
done to avoid or reduce the risk of technical errors.
With the appropriate indications and pre-operative
Conservative surgery without excision of the
studies - Grade A
saphenous trunk
The aim is to treat the varicose veins,
maintaining the saphenous drainage but not the
Symptomatic ablative surgery
reflux.
Nowadays this is a phlebectomy with or without
Saphenous
physiologically
flow
can
be
(sapheno-femoral
directed
external
incisions, according to Muller, and may be either
valvuloplasty and first step of the CHIVA 2 strategy
used to cure varicose veins or complementary to
- see below) or reversed and directed towards the re-
other techniques.
entering perforating vein (CHIVA 1).
The Muller method is technically preferable as
These techniques can be complemented by
it gives less trauma and a better esthetic and
phlebectomy but an echo-Doppler examination must
functional result. An incision of few millimeters is
be done beforehand.
made and the incompetent branches of the
superficial circulation, with the exclusion of the
Sapheno-femoral external valvuloplasty
saphenous junction, are removed through this
The rationale for this treatment is based on the
incision using special instruments (37,38).
Another technique for treating the symptoms is
histological finding that in the initial stages the
to incise the thrombosed varicose branches to ablate
valve cusps are still healthy but are incompetent
them or, in the case of superficial venous
because of dilation of the vessels walls (63,64).
thrombosis, simply squeeze out the thrombotic
material.
The aim of the intervention is to bring the valve
leaflets back together, closing the dilated vessel
walls. This can be done by either suturing the wall
directly or by “banding” the vessel with some sort of
Recommendations:
external prosthetic belt. An ultrasound examination
must be made to check that the valve is mobile and
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September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
not atrophied at the terminal or subterminal level of
A simple crossectomy gives functional results
the greater saphenous vein. Competence can be
in the treatment of varicose veins, but is less
tested during the operation using the milking
effective than stripping. (67,68). Crossectomy with
maneuver and/or a Doppler scan.
phlebectomy gives results comparable to stripping
only when it is based on thorough preoperative
CHIVA type 1 hemodynamic correction
radiological or ultrasound examination (69-71).
This is done when the perforating re-entry vein
Endovascular treatment
of a refluxing saphenous system is on the saphenous
trunk. The sapheno-femoral vein is disconnected
This heading includes positioning Van Cleef
and the saphenous vein is freed of any incompetent
type clips under radiological guidance, and treating
branches, with or without a phlebectomy. The
the walls at the height of the terminal valves with a
perforating re-entry vein should be treated by tying
heat-transmitting radio probe.
it off or sectioning the saphenous vein downstream
of its entry point (terminalization) (40,65).
Recommendations:
CHIVA type 2 hemodynamic correction
As yet, there are not enough studies of an adequate
This is done when the penetrating re-entry vein
level to validate any of the interventions which aim
of a refluxing saphenous system is on a tributary of
to preserve the saphenous trunk, although for some
the
of them phase II trials have been completed or are in
saphenous
vein.
The
tributary/ies
are
disconnected flush from the saphenous wall by
progress. Grade C.
clipping and a phlebectomy may be carried out (66).
In 60% of cases, after 18 months, this is the only
intervention required. In the remaining cases the
SURGERY OF THE PERFORATING VEINS
treatment will need to be completed by a CHIVA 1
hemodynamic correction or by repeating this
The perforating veins supply blood through the
procedure depending on the hemodynamic outcome.
muscular aponeurosis to the superficial and deep
venous systems. These veins are numerous, from 80
Crossectomy with or without phlebectomy.
to 140 per leg, the diameters not exceeding two
millimeters. The valves are normally located in the
sub-aponeurotic area.
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Venous examination must assess the anatomical
There are two main procedures for surgical
and morphological criteria in parallel with the
treatment of perforating veins: the traditional
hemodynamic criteria.
method (of Linton, Cockett, Felder, De Palma) for
A reflux is defined as
pathological if it fulfils the following criteria:
the suprafascial and subfascial veins (78) or
- duration more than one second
endoscopic treatment of the subfascial veins.
- caliber of the perforating vein more than 2
Indications for traditional surgical and endoscopy
mm, calculated from the ultrasound findings.
are incompetent perforating veins of the leg and
The severity of the CVI in relation to incontinent
active or healed ulcers (CEAP classes C5- C6); this
perforating veins is based on the number of
mainly
perforating veins involved and, in particular,
Treatment of perforating veins due to superficial
whether
system
vein inadequacies is reserved for symptomatic cases.
(superficial/deep/perforating) is involved (72,73);
Some studies suggest the surgical approach for
there may be a venous–venous shunt starting in the
patients with symptomatic cutaneous dystrophy
deep venous system and involving the saphenous
(CEAP class C4) (79,80).
more
than
one
involves
post-thrombotic
syndromes.
vein, the perforating veins or even the pelvic veins,
or a venous-venous shunt established in the
Traditional surgery
superficial system (74).
However, there is some controversy over the
The various traditional treatment methods give
identification of incontinent perforating veins in the
broadly similar results, with 9-16.7% of patients
leg. Doppler ultrasound appears to be the most
having recurring ulcers when followed up for 5-10
reliable investigation, but there is still debate about
years (78, 81, 82). The percentage of recurring
the best method (75,76).
ulcers in patients with post-thrombotic syndrome is
Elimination of the incontinent perforating veins
higher (>16%) with a five-year follow-up.
in combination with drainage of the varicose veins
Some authors have combined these methods
and restoration of the saphenous return in patients
with venous bypass (83), valve grafts and endoscopy
with severe chronic venous insufficiency is one
(78), but the outcomes cannot be compared.
therapeutic approach for trophic disorders of the
skin (77).
Considerations: No substantial differences have
been observed between the traditional techniques
and there are as yet no multicenter trials to compare
Surgical treatment
the results of the different traditional approaches
alone or in association with other methods.
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Endoscopic surgery
In patients with post-thrombotic syndrome treatment
of incontinent perforating veins, whether with
Endoscopy, a recent concept in this field, uses
sclerotherapy, traditional surgical techniques or
single access (one trocar) or double access
endoscopy, has a pivotal role. Grade B
(operating trocar and optic). A number of studies
For varicose veins it is essential to distinguish the
report recurrent ulcers at five-year follow-up in 0-
hemodynamic role of the perforating veins of the
10% of cases (80, 84-87).
thigh (Dodd and Hunter perforating veins) and the
Many
endoscopic
authors
treatment
have
with
associated
drainage
surgical
Boyd communication perforating veins. When these
of
are incontinent they must always be closed or
the
incontinent superficial venous system, reporting
removed.
For any other perforating veins, the
similar proportions of recurrent ulcer at five years of
clinical aspects and the radiological findings must
follow-up. One multicenter trial, however, which
be taken into account. Grade C.
compared endoscopic surgery alone with endoscopy
plus drainage of the superficial system, found a
smaller percentage of recurring ulcers in the second
group at two years of follow-up (86).
RECURRENT VARICOSE VEINS
Considerations – Multicenter trials are currently
in progress to evaluate endoscopy compared with
These are varicose veins that appear after surgical
traditional treatment and whether it is appropriate to
treatment, not the remains of the treated veins (88-
combine this with plastic surgery for the ulcers.
92).
Regardless of the methods used, the worst results
lower limbs appears to be a simple procedure, there
have been seen in patients with post- thrombotic
are a number of traps. The high percentages of
syndrome.
recurrences reported in the international literature
At present, endoscopic surgery is preferred to
Although surgery for varicose veins in the
confirm this (88-93).
However, it is difficult to
traditional techniques as it is less invasive, causes
interpret these findings, as the patient populations
fewer post-operative complications and, under
differ and the diagnostic and therapeutic protocols
endoscopic guidance, it is possible to work at a
vary.
distance from the site of ulceration.
The most frequent causes of recurrences are:
- errors
in
the
diagnostic
strategy
and
inappropriate treatment
Recommendations:
Vol. 1 – Suppl. 1 to No. 1
- technical errors.
ACTA PHLEBOLOGICA
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Errors of diagnostic strategy and treatment
Crane described 57% crossectomy ligatures that
were incorrectly executed.
The long-term results of surgical treatment of
Marques reported 54.5% of incorrect ligatures
varicose veins depends on correct diagnosis. If the
in cases of re-operations for recurring varicose
hemodynamic causes of the varicose veins are
veins.
properly identified an appropriate treatment plan can
be chosen (94). “Radical surgery”, defined as
Tong
found
168
(68.9%).saphenous
vein
residues in 244 lower limbs studied
physical extraction of the saphenous vein with all its
Of all the causes of error during surgery for
collaterals and all the enlarged varices, which has
varicose veins in the lower limbs, the main one is
been the surgical procedure of choice for varicose
the wide range of anatomical variation at the
veins for almost a century, is increasingly being
junction of the saphenous-femoral veins which may
replaced by “radical hemodynamics”, meaning
cause the surgeon to leave some collaterals in place.
elimination of all the hemodynamic defects which
are at the root of the formation of the varices (the
Treatment
reflux).
Mapping was started a decade ago to ensure
reproducibility
over
time
(40).
A
sort
Surgery: The most suitable seems to be the lateral
of
subfascial approach where the technical difficulty of
“geographical” map of the varicose veins and
dealing with cicatricial sclerosis is not encountered
circulation defects of the lower limbs is used in both
(99, 100); this is reserved for cases where there is a
CHIVA interventions and “traditional” surgical
residual stump of the saphenous vein with
procedures. Incorrect application of these concepts
collaterals. Where indicated, varicectomies using
can leave the way open to recurrences.
Muller micro-incisions and hemodynamic correction
of the incompetent perforating veins is performed.
Technical errors
Pharmacological and compression treatment or
sclerosing therapy: Used in all cases in which
Numerous papers have given incontrovertible
evidence of a high number of errors, frequently
serious, made during operation (93, 95-98).
surgical treatment is not indicated or as an
alternative.
Mixed: A combination of the two approaches.
Haeger in an autopsy study reported 158
(15.1%) residual saphenous veins in 837 lower
limbs that had been operated on for varicose veins.
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
prior to the procedure about the type of
intervention and/or treatment.
Recommendations:
They should
signed a personalised informed consent form;
The likelihood of varicose veins recurring as the
- the lines between the interventions feasible
disease progresses remains. To limit the risk correct
under the various regimens are blurred.
diagnosis is essential.
This is routinely done by
Therefore, the medical team will decide which
ultrasound (Levels I and II), leaving selective
type of regimen is best suited to each patient,
phlebography for special cases (Level III) in order to
after having carefully selected and informed
minimize the risk of error. Grade C
them individually about the choice of regimens
available;
- selection must take into account the patient’s
NATIONAL HEALTH INSURANCE (ITALIAN)
general condition and any pertinent family and
CLASSIFICATIONS
logistic factors;
- patients who are entered in walk-in and day
A proposal for regulations (101) has been made
surgery programmes must be in good general
to cover clinical, organisational and administrative
health. The ideal candidates are classified as
possibilities for surgical interventions, invasive and
ASA classes 1 and 2. Emergencies cannot be
semi-invasive
dealt with on this basis;
diagnostic
and/or
therapeutic
procedures without hospital admission and without
- age and weight selection criteria apply. With
the need for post-operative observation; such
few exceptions, the upper age limit is 75 years.
procedures can be done in the consulting room, in
Obesity is a very important risk factor and must
out-patient or other supervised centers, using local
be very carefully evaluated.
and/or local-regional anesthetics. Three possible
- as regards logistics, the patient’s home should
regimens for surgical treatment of varicose veins are
not be too far from the place where the
given: walk-in, day surgery or standard admission.
operation will be done. The patient should be
Day surgery is probably suitable for the
reachable in a short time, if necessary.
majority of surgical interventions for varicose veins
Therefore the travelling time should be less than
as long as specific selection criteria are used:
one hour. Another requirement is that phone
- procedures carried out as day surgery should
contact with the center should be possible;
preferably last less than one hour
- patients must have a family member or
- patients scheduled for this treatment must be
reliable person with them during the recovery
very carefully selected and should be informed
period, particularly during the first 24 hours
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ACTA PHLEBOLOGICA
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
after surgery.
This person should be given
Certain clear observations justify hospital
detailed instructions and should be able to
admission. In such cases, regardless of the doctor’s
accompany the patient home and give any
opinion whether day surgery is possible or not, the
assistance the patient might require, particularly
patient must agree to being operated in hospital. If a
in the first 24 hours;
patient, for whatever logistic or psychological
- the decision to enroll a patient in a particular
reason, does not want to be operated in day surgery
regimen is the exclusive responsibility of the
but insists on hospital admission, this is a valid
doctor, who, after obtaining the patient’s
reason for the NHS covering the whole cost,
informed consent, must be at liberty to select
provided it is clearly documented in the clinical
the most suitable regimen, on the grounds of the
records and on the informed consent form.
sound scientific and ethical principles always
Logistic and family factors are particularly
underlying health care;
important in Italy and they can be justification for
- the choice of the most suitable regimen will be
admitting a patient the day before the procedure,
guided
and
provided there are also valid health care reasons.
the
The period after discharge must be carefully
lend
organised: the patient must be properly accompanied
themselves to treatment under a walk-in
after discharge, s/he must be able to contact the
regimen should, if they are more extensive or
center easily for advice or help and must be able to
complicated, be treated in the day surgery or
return there easily if complications arise. Any
actually in hospital.
logistic situation which does not comply with these
- finally, even if a pathology or surgical
requirements must be described in the patient’s
procedure appears on the official list of services
records and may justify a longer stay.
by
the
psychological
pathologies
patient’s
condition.
that
would
clinical
Many
of
normally
available in day surgery, this does not oblige a
Current DRG data for varicose vein surgery
doctor necessarily to carry out the treatment
(101) show an average stay in hospital of 3.7 days;
under that regimen.
54.3% of these patients stay in hospital 2-3 days;
under-use of day surgery is limited to 8.3% of cases.
However,
various
difficulties
are
still
encountered in Italy due to the very high demand for
Surgical treatment of deep venous reflux
these procedures, and there is no obligation for a
patient to be enrolled in any particular regimen
Candidates for deep venous surgery suffer from
without a specialist’s evaluation and without giving
severe CVI, with significant venous reflux and
informed consent (102)
ambulatory
22
ACTA PHLEBOLOGICA
venous
hypertension.
Conservative
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
therapy has failed for these patients and the venous
-external valvoplasty with prosthetic cuff
disease reduces their quality of life. When the deep
- external valvoplasty with direct sutures;
vein reflux is slight, stripping of the saphenous vein
- venous graft.
can bring considerable benefit and eradicate the
There were no significant differences in the
reflux
in
the
femoral
vein
(103).
recurrence of ulcers with these various methods.
However, if there is severe, fast reflux, the deep
venous
system
will
require
direct
surgery,
The time is ripe for standardisation of pathology
reports,
clinical
reports
and
hemodynamic
considering the high percentage of recurring ulcers
parameters so that the different surgical techniques
after conservative treatment and the excellent,
can be compared in randomised prospective trials.
lasting results obtained in centers that opt for the
direct approach.
Reconstructive valvular surgery includes direct
Recommendations:
methods, which aim to restore the competence of the
valve, and indirect methods, which aim to improve
These surgical approaches are not recommended for
the venous hemodynamics of the limb (104-107).
routine use; they should be reserved for cases with
Direct surgical methods are indicated in PPVI when
specific indications, and done by surgeons with the
the valve cusps are dilated or prolapsed but still
necessary skills, in well-equipped facilities Grade
present and functioning.
C.
In STP or valvular
agenesis when the valves are damaged or absent an
indirect technique is the better therapeutic choice.
CVI is a complex pathology as the venous
circulation involves so many levels and systems.
Rapid healing of stasis ulcers can be achieved by
correcting all the points of reflux and maintaining or
setting up venous return channels. Depending on
the site and extent of the valvular lesion a variety of
surgical techniques can be used.
In a review of 423 valve reconstructions Raju
(108) listed the duration of success of the surgical
methods, monitored with Doppler ultrasound, in the
following order:
- internal valvoplasty;
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ACTA PHLEBOLOGICA
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
The initial obliteration of the vein is obtained in
SCLEROTHERAPY
more than 80% of cases; however, part of the
sclerosed veins will subsequently open again.
Definition
Sclerotherapy is the chemical obliteration of
varicose veins. The veins are injected with a histo-
INSTRUMENTAL STUDY OF INDIVIDUAL
VEINS
lesive substance (sclerosing liquid) which damages
the endothelium, producing spasm, thrombosis and
In studies monitored using Doppler examination
an inflammatory reaction which are intended to
or ultrasound the greater saphenous vein was
produce stenosis, fibrosis and the permanent
obliterated in 81-85% of cases (109, 110), but one
obliteration of the vein (Table I).
year later between 17% and 35% of cases had
Tabella I da comporre
opened again (111, 112), 33%, 60% and 80% of
Table I – The most widely used sclerosing
cases after two years (113, 114, 75) and 48% after
substances: indications and concentrations
three years (112).
Substance
Similar results have been obtained with the
Glycerin chromate
small saphenous vein, which was initially closed in
Sodium salicylate
87% of cases (109) but after two years there was
Polydocanol
blood flowing again in 33% of cases (113), while
Sodium tetradecyl sulphate
after five years recanalisation was found in 27%
Sodium iodine/iodide
when the popliteal vein was competent (primary
Type of varices and recommended concentration
varicose veins) and 77% when the popliteal vein
Teleangectasias
was incompetent (secondary varicose veins) (115).
Spider veins
In the single trial covering collateral veins, at
Small/medium varices
two years 26% were patent again (113).
Large varicose veins
Saphenous vein segments
CLINICAL TRIALS
inserire i dati dalla tab.I, p.16, cambiando le
From 1984 to 1996 four prospective
virgole in punti!
randomised clinical trials with clinical monitoring
were conducted. These showed that at the beginning
Efficacy
sclerotherapy gave results comparable with those of
surgical extirpation; but, over time, the recurrence of
24
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varicose veins was definitely more frequent after
the best option. However, though combined therapy
sclerotherapy.
proved more effective than sclerotherapy alone, it
In Doran's trial (116), after two years the results of
was always less effective than surgical removal of
sclerotherapy and surgery were the same. Chant and
the varicose veins.
Beresford (118, 117) found that after three and five
Lofgren (124) already reported this in the
years recurrence with sclerotherapy was respectively
Fifties, on the basis of a retrospective study: at five
22% and 40%, in contrast to 14% and 24% with
years, there was 70 % recurrence with combined
surgery. In Hobb’s trial (119), one, five and ten
therapy but only 30% with surgery. In Jacobson's
years after sclerotherapy recurrences were seen in
prospective trial (58) recurrence at three years was
8%, 57% and 90% respectively, compared with 6%,
35%
25% and 34% after surgery. Jacobson (58) found
sclerotherapy alone and 10 % with surgery alone.
63% of recurrences after three years, as opposed to
10% after surgery.
with
combined
therapy,
63%
with
In Neglén’s trial (125) after combined therapy
21% of patients had residual varices, while after five
years the recurrence rate was 84%. Volumetric
TRIALS
WITH
CLINICAL
AND
INSTRUMENTAL MONITORING
measurements of the feet, normal after treatment,
had already deteriorated after one year and after five
years had returned to the pre-treatment values.
In Einarsson’s trial (120), after five years the
In Rutger’s trial (61), after three years the
recurrence rate was 74%, in contrast to 10% with
recurrence rate was 61% with ligature and
surgery. In this trial the results were checked by
sclerotherapy
measuring hemodynamic parameters (volumetric
phlebectomy. Doppler scanning showed saphenous
measurements of the feet), but even using these
reflux in 46% of patients in the first group and 15%
criteria the results of surgery were better.
of the second. This is the only study in which there
and
39%
with
stripping
and
were more clinical failures with sclerotherapy (61%)
COMBINED THERAPY
than saphenous recanalisations detected on Doppler
scanning (46%). In all the other studies, half the
Between 1973 and 1975 three unsigned
cases of recanalisation detected instrumentally
editorials in the British Medical Journal and the
showed clinical improvement. However, these
Lancet (121-123), proposed that, as regards both the
objective failures with sclerotherapy were partially
results and the cost/efficacy ratio, a combination of
mitigated by the patients’ subjective evaluations
surgery at the sapheno-femoral junction and
which were invariably better than the surgeon’s.
sclerotherapy for the remaining varicose veins was
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Table I – The common sclerosing drugs. Indications and concentrations.
EV
Drug
AL
Telangiectases
UA
Chromated Glycerin
Sodium salicylate
Polidocanol
Sodium tetradecyl sulphate
Iodine/sodium iodide
TIN
G
72 %
8%
0.25-0.5 %
0.1-0.2 %
-
Type of varicose vein and recommended concentration
Reticulated varices Small-medium
Large varices
varices
12 %
20 %
1%
1-2 %
3-4 %
0.2-0.3 %
1-2 %
3%
2%
2-4 %
Saphenous trunk
3-4 %
3%
4-8-12 %
TH
inadvisable (because it is difficult, with uncertain
E EVIDENCE
results or high risk), or is specifically requested by
Despite some criticisms, all the trials published
the patient, who must be fully informed of the likely
so far – six prospective and randomised (116-120,
results,
complications,
advantages
and
58, 61), one retrospective (124) and one prospective
disadvantages of sclerotherapy in comparison with
controlled (125) – have given unanimous results,
surgery.
definitively showing the superiority of surgical
Sclerotherapy was introduced in France in
excision over sclerotherapy and combined therapy,
1853, but the first attempts at producing guidelines
at least for varicose veins with incompetence of the
were only made in 1996, by the International
greater saphenous vein.
Consensus
Conference
(1996),
the
American
Academy of Dermatology (126) and the American
Venous Forum (74). However, only the American
Venous
Recommendations:
Forum
specifically
formulated
the
indications for sclerotherapy, which are the same as
Surgical
removal
sclerotherapy
for
is
more
varicose
effective
veins
due
than
to
incompetence of the greater saphenous vein. Grade
the ones the Collegio Italiano di Flebologia is
proposing here. These indications include:
1) telangiectasias;
2) small diameter varices (1-3 mm);
A.
3) residual veins after surgery (purposely left by
the surgeon)
4) varicose veins recurring after surgery (if
Indications
originating from a perforating vein <4 mm
The high rates of recanalisation and recurrence
mean that sclerotherapy is a secondary choice, not
an alternative to surgery. It becomes the treatment
of choice only in cases in which surgery is
26
diameter)
5) varices from venous malformations (KlippelTrenaunay type) for which surgery is not
advisable;
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
6) emergency treatment for bleeding ruptured
varicose veins
the lower limb. Caution is needed in patients with a
history
of
recurring
DVT,
with
confirmed
7) perforating veins <4 mm diameter
thrombophilia, women taking estrogen/progestogen
8) varicose veins around an ulcer
preparations, or who are pregnant.
As this list shows, sclerotherapy is an important and
Techniques
indispensable method for the optimal treatment of a
wide range of varicose veins, from spider veins,
Like any manual technique, sclerotherapy has to
which are not just anesthetic problem but can cause
be learned. The various techniques currently in use
skin pathologies and even serious hemorrhage, to
are derived from three European schools, Tournay
the serious, disabling forms of CVI such as
(127), Sigg (128) and Fegan (129), and are
lipodermatosclerosis, stasis ulcers and congenital
described in Italian in two publications (130,131).
venous malformations.
The type and concentration of sclerosing fluid
varies according to the type of varicose vein and is
shown in Table 1. Injections are given in more than
one sitting, a few days or a few weeks apart,
Recommendations:
depending on the individual technique.
Better
The AVF indications apply. There is an open verdict
results are obtained, with fewer adverse effects, if
on the indications for sclerotherapy of the
the injected vein and the leg are immediately
perforating veins of any diameter and of the small
compressed with either adhesive or free bandages or
saphenous vein. Grade B.
with
elastic-compression
stockings
(132).
Compression is all the more important, and needs to
be more prolonged (from three to six weeks or
more) if the varicose veins are particularly large and
Contraindications
The contraindications to sclerotherapy include
allergy
to
the
sclerosing
solution,
serious
decompensated systemic disease, recent DVT, local
or systemic infection, non-reducible edema of the
lower limb, immobilisation and critical ischemia of
diffuse. In some cases – e.g. large varicose veins or
legs with a tendency to edema - compression is
indispensable.
In the last few years injection of sclerosing
fluids
under
ultrasound
guidance
(ultrasound
sclerotherapy) has been introduced (109), but it has
not yet been confirmed more efficient in the long
term. Also requiring confirmation is the utility of
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injecting detergent-based sclerosing compounds
(polydocanol or tetradecyl sodium sulphate) in
Recommendations:
microfoam form rather than liquid (133,134).
There is no standardisation of the technique, or of
the concentrations and amounts of sclerosing agents.
Compression improves the results of sclerotherapy.
Grade B.
COMPRESSION
Definitions
Compression is the pressure applied to a limb,
using a variety of materials, elastic or firm, to
prevent and treat diseases of the venous or
lymphatic systems.
Historical outline
Elastic compression treatment has been used
throughout the history of medicine. Traces of the
use of bandages have been found among the Ancient
Egyptians and the tribes living along the River
Tigris. The prophet Isaiah in the 8th century B.C.
wrote about the utility and purposes of bandaging
the legs, as did Hippocrates and his school of
medicine.
The Roman legionnaires in 20 B.C.
bandaged their legs tightly during long marches to
prevent stiffness. Aurelio Cornelius Celso, a Roman
author writing at the time of Tiberius, recommended
occlusive and compressive linen bandages for
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treating ulcus cruris. And throughout the medieval
Physiological and technical rationale
period, influenced by Arabic medicine, compressive
dressings were widely employed.
In phlebolymphology the materials used to
achieve compression are bandages, elastic and
inelastic hose (138,139).
Physiopathology
The venous system, assisted by the lymph
BANDAGES
vessels, returns the blood from the tissues to the
heart. Every time the venous flow is slowed or
Bandages are generally used to protect the
impeded a sort of “traffic jam” build up: ischemia
lower leg. The most important property of bandages
occurs in the cells, as the stasis prevents oxygen and
is that they can stretch or expand. The expansion
nutrients leaving the arterial capillary wall to enter
factors in relation to the initial size are:
the interstitial space and get to the cell walls where
- small expansion (<70%);
they are absorbed. This is because of an inversion of
- medium expansion (70-140%);
the local pressure ratios; the slowing of the blood
- long expansion (>140%).
flow causes an increase in interstitial pressure which
The inelastic or barely elastic bandage produces
counterbalances the residual arterial hydrostatic
a considerable amount of “working” pressure when
pressure.
walking, as it prevents the increase in the
The lack of flow leads to an increase in perivascular
circumference of the leg caused by contraction of
oncotic and osmotic pressures, causing water
the calf muscles, whilst the pressure at rest is
retention and edema, a self-sustaining cycle.
minimal. In contrast, the elastic bandage exerts a
Compression therapy works by changing the
moderate amount of "working" pressure and high
venous hemodynamics; there is an increase in the
"resting" pressure, the difference between the two
flow speed (evaluated using plethysmography and
being inversely proportional to the elasticity. An
venous occlusion), a reduction in the vessel
elastic bandage maintains continuous pressure on
dimensions,
the superficial venous system which is relatively
(confirmed
and
by
valvular
Duplex
competence
scan).
returns
Rheographic
independent of muscular activity.
examination shows an increase in the refilling time
Elastic bandages made of fibers with a long
after exercise, an indication of improved venous
expansion factor act in a similar way. Inelastic or
compliance. Overall, the reduction in pericellular
barely elastic bandages can be worn day and night
edema limits tissue damage (135-137).
whereas bandages that stretch more than 70% and
support stockings should be taken off at night, as
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they are not designed to be worn when the patient is
- stockings
lying down (140,141).
- single leg tights
Taking into account the various types of
bandage, the pressure exercised is always found by
- tights.
There are also “cuffs” for the arms.
using the Laplace law:
When pressure on the ankle is less than 18 mm
Hg the support is defined as preventive or resting.
There is controversy over whether this is effective,
P = t/r
just as debate continues on the utility of hosiery
whose pressure is expressed in “deniers” (den).
modified as follows for a bandage:
When the pressure on the ankle is greater than
18 mm Hg the support is defined as therapeutic.
P = tn/ra
Graduated, defined compression is achieved on the
where t is the tension, n the number of turns of the
lower limb, decreasing from the bottom towards the
bandage, r the radius of the circumference of the
top, being 100% at the ankle, 70% at the calf and
compression, and a the width of the bandage.
40% at the thigh. Depending on the compression at
Compression can thus be “dosed” to meet treatment
the ankle, expressed in mm Hg, therapeutic support
requirements.
hose are grouped in four classes, which differ
The length of time the bandages are worn is not
standardised.
Some studies show equal efficacy
according to whether the German standards or the
French standards are followed.
with bandages worn for a few hours or for six
Manufacturers of therapeutic elastic support
weeks; there is a significant drop in the amount of
stockings based on the German RAL GZ 387
compression exerted by a bandage 6-8 hours after
standards give four classes of compression:
application (142,143).
Class
ELASTIC SUPPORT HOSE
Compression in
mm Hg
1
18.7 – 21.7
Elastic support hose, for prevention or therapy
2
25.5 – 32.5
(144-146) are manufactured in various sizes, either
3
36.7 – 46.5
standard or to measure, and are classified according
4
> 58.5
to their length as:
- knee-length socks
- mid-thigh stockings
30
Based on the French NFG 30-102 B standards
therapeutic elastic support stockings are also
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September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
grouped into four compression classes but these
guarantee the correct gradient along the length of the
have lower values:
lower limb;
- specifications for the manufacture of the
Class
Compression in
circumferential stretch;
mm Hg
1
10 -15
2
16 - 20
3
21 – 36
4
> 36
hosiery, with details of both the longitudinal and
- specific methods for the stitching, the seams,
the heel, etc.
- the materials which must be used are given,
with precise limits for the thickness of the yarn, so
the product will be strong enough to ensure its
Besides these support stockings for prevention
properties remain constant over time;
and therapy there are also “antiembolism” support
stockings for the prophylaxis of thromboembolism.
- finally, there is a section on the inspection
methods for the finished stocking.
These are different from the other models as they
The RAL-GZ 387 standards are entrusted to
give a standard compression of 18 mm Hg at the
two authorities, one in Germany and the other in
ankle and 8 mm Hg at the thigh and can be worn
Switzerland. The preliminary tests (HOSY system)
comfortably even when resting.
certify that the support hose complies with the
technical specifications, with particular attention to
the
Manufacturing standards
visual
checks,
tests
for
transverse
and
longitudinal elasticity, and analysis of the materials
The manufacturing standards for an elastic
used. There is also a sophisticated test to measure
support stocking were drawn up at the request of the
the compression and how it decreases from the base
German authorities, as these appliances are eligible
of the stocking towards the top. This test is
for national health system reimbursement, and
conducted using special equipment which can
appear in the official German drug formulary (CEN
measure any type of elastic stocking and record its
documents).
static and dynamic performance.
These very strict and restrictive standards have
These standards comprise:
- a table establishing the four classes of
been used for thirty years to monitor the production
compression to which all the support hose for
and distribution of elastic support hose in Germany
compression treatment belong;
and are proposed as the model for European Union
- a table showing the pressure distribution for
regulations.
the different classes, so the elastic support will
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INELASTIC COMPRESSION
compression for the symptomatic treatment of CVI
or the prevention of complications is supported by
Intermittent Pneumatic Compression
clinical experience and by a substantial amount of
scientific literature, particularly for the advanced
This is indicated for the prophylaxis of venous
stages of venous disease. However, only the most
thromboembolism and the treatment of venous
recent publications satisfy the extremely rigorous
ulcers.
case/control comparison criteria, with adequate
Intermittent pneumatic compression (IPC)
increases venous blood flow during periods of
sample sizes.
immobilisation. IPC devices are adjuvant measures
The type of compression used, the method of
for the treatment of lower limb edema, venous
application and length of time used will vary
ulcers or both, and for the prevention of pulmonary
according to the clinical context and for each patient
thromboembolism.
even in groups with the same pathologies.
IPC should be considered for patients with a
Therefore the choice of compression hose needs to
high risk of hemorrhagic complications or in whom
be centered on individual requirements and the
a minor bleed could have serious consequences.
severity of the disease.
IPC is indicated for patients who have had
In order to unify the evaluation criteria for acute
neurosurgical surgery, major urological, eye, spinal
and
and knee surgery. It is also indicated in patients with
prophylaxis and treatment, generalised classification
suspected or documented intracranial hemorrhage or
standards must be used. These are the CEAP
after recent cerebral or spinal traumas.
international
IPC as coadjuvant therapy for venous ulcers.
high/moderate/low risk classifications from the
IPC is indicated in the treatment of venous
ulcers, giving a higher recovery rate, in a shorter
chronic
venous
insufficiency,
classification
for
CVI
and
and
its
the
Consensus Statement on Prevention of Venous
Thromboembolism.
time.
ACUTE FORMS
Clinical applications
Superficial thrombophlebitis
GENERAL POINTS
Superficial
thrombophlebitis
is
considered
Compression is indicated for any chronic or
benign if there are no thrombophilic risk factors, and
acute venous insufficiency, either associated with
is one of the common complications of varicose
other treatments or alone.
veins.
32
The efficacy of
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However, it may progress to pulmonary
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
embolism and this can be fatal. In the majority of
thrombophlebitis cases, with or without varicose
Recommendations:
veins, after drug therapy (anti-inflammatory drugs
and
heparin)
elastic
compression
hose
and
Compression and mobilisation are always indicated
mobilisation are the first line of defence for both
for patients with superficial thrombophlebitis.
treatment and prevention. (147).
Grade B
Deep vein thrombosis
Prevention
The graduated-pressure elastic stocking reduces
the incidence of DVT after surgery, using an
optimum pressure of 18 -20 mm Hg at the ankle and
8 mm Hg at the thigh (148,149).
Recommendations:
Low risk
In the absence of sufficient data, there is general
agreement that graduated compression is useful.
Grade C
Moderate risk
Elastic stockings in combination with, or as an
alternative to, heparin prophylaxis. Grade B
High risk
As for moderate risk or in combination with other
methods of prophylaxis. Grade B.
Treatment
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Although evidence from controlled trials is still
lacking, the current treatment for DVT remains
COMPRESSION
based on heparin.
SCLEROTHERAPY FOR VARICOSE VEINS
Mobilisation and compression
AFTER
SURGERY
OR
have long been recommended by some specialists,
even in the acute phase of DVT (150,151).
Compression after surgery is indicated for the
However, opinions still vary about the early
prevention
of
venous
mobilisation of patients with DVT or the preferred
prevention
of
hematoma,
method of compression using inelastic, mobile or
postoperative problems and the prevention of
adhesive bandaging, or elastic stockings.
recurring varicose veins (141,153,154).
thromboembolism,
the
treatment
the
of
For the time being it is not possible to make
recommendations.
Recommendations:
PREVENTION
OF
POST-THROMBOTIC
SYNDROME
Patients who have had active treatment for varicose
veins
(surgery
and
sclerotherapy)
Post-thrombotic syndrome (PTS) is an aftermath of
require compression support hose, but it is not
DVT in between 10 and 100% of cases; it may cause
possible to specify the types. Grade B.
moderate to painful disabling edema, and trophic
cutaneous changes leading to ulceration. The use of
elastic knee-socks with 40 mmHg compression at
CHRONIC FORMS
the ankle for at least two years has been endorsed by
a randomised controlled trial where it halved the
a) Functional symptoms of mild venous
incidence of DVT when the stocking was used
insufficiency (CEAP 0 = no visible signs of venous
regularly (152).
disease)
There is no reliable data on the efficacy of “resting”
or “preventive” commercial support stockings (155).
Recommendations:
After DVT elastic stockings should be worn for at
Recommendations:
least two years, with compression of at least 20 mm
Hg. Grade A
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There is not sufficient data to give indications for
the use of resting or preventive elastic support hose.
Recommendations:
Grade C
Compression treatment is recommended. As only a
b) Telangiectasias and spider veins (CEAP 1)
small number of published trials included an
Venous ectasia accompanied by clinical symptoms
adequate number of subjects it is not possible to
of CVI are an indication to increase compression at
give firm advice on the compression levels at the
the ankle and consequently on the calf and thigh
ankle, although it should be more than 18 mm Hg.
(156).
Grade B
Recommendations:
d) Edema (CEAP class 3)
Edema is a common complication of venous
As the physiopathological data is not compatible
insufficiency even in early clinical stages. There is
with the indications described it is not possible to
slight swelling around the ankles towards the end of
recommend compressive support hose for long-term
the day in CVI, more marked in varicose diseases
use in these conditions. Grade B
with skin disorders and stasis ulcers. It is caused by
changes in the interstitial pressure ratios caused by
venous hypertension (144).
c) Varicose veins (CEAP class 2)
Compression is considered fundamental in the
clinical management of patients with varicose veins,
as it reduces the feeling of heaviness and pain and
acts on trophic changes in the tissues, either alone
(117, 157, 71) or in combination with drug therapy
(158). For a small group of 31 patients who had
varices without complications, low- compression
stockings, exerting 20 mm Hg at the ankle, were as
effective
clinically
and
hemodynamically
as
stockings giving 30 mm Hg compression, and
compliance was better (159).
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bandages, multilayer bandages or IPC are useful. A
review of the literature, published in the BMJ in
Recommendations:
1997 (161), which considered all the available trials
Given the small amount of literature, the few
on the treatment of venous ulcers, concluded that
clinical
compression improved the prognosis of this
trials,
and
considering
that
the
indiscriminate use of compression therapy could
condition, preferably using high pressure.
There
spoil the quality of life for patients, it is impossible
does not seem to be any one system which is better
to give any general indications for compression
than the others (multi-layer, short-stretch bandaging,
therapy. Grade C
Unna boot).
e) Trophic changes of venous origin, pigmentation,
Recommendations:
eczema, subcutaneous inflammation, healed ulcers
Compressive therapy is recommended for the
(CEAP classes 4 and 5).
Skin changes in chronic venous disease are
treatment of venous ulcers (inelastic bandaging,
indicators of serious tissue damage caused by
knee-socks with compression >40 mm Hg). Grade
hypoxia from chronic stasis. A review of the
A
literature by Moffat (160), showed recurring ulcers
in 2/3 patients without compression therapy.
Table II – Venous physiopathological processes
affected by drug therapy
Recommendations:
-
Reduced venous tone
-
Hemoconcentration
Compression therapy is recommended for the
-
Depressed venous-arteriolar reflux
prevention of recurring ulcers (30-40 mm Hg at the
-
Vasomotor disturbances
ankle). Grade B.
-
Increase in capillary permeability
-
Edema
-
Pericapillary fibrin cuff
-
Reduced fibrinolysis
Venous ulcers can be effectively treated with
-
Increase in plasma plasminogen
compressive therapy after local surgical and/or
-
Changes in leucocyte and erythrocyte rheology
pharmacological therapy. Elastic stockings, Unna
-
Leucocyte activation
f) Venous ulcers (CEAP class 6)
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-
Capillary microthrombi
Phlebotrophic drugs are the therapeutic strategy
-
Stasis of the microcirculation
of choice for CVI patients who are unsuitable or not
-
Reduced lymph drainage
indicated for surgery, or for whom surgery is
coadjuvated by drug therapy (165-170).
DRUG THERAPY
Pharmacotherapy for CVI has greatly developed
over the last 40 years. It is therefore surprising that
there are no clinical or experimental trials to study
the tone and contractility of the veins nor venous
pressure in relation to treatment problems (162).
Drugs for the venous system were initially
called phlebotonics as they were believed to act on
venous tone.
They are still largely used in the
symptomatic treatment of CVI and to make patients
more comfortable (163).
Phlebotrophic drugs in their modern form are
aimed at a wide range of processes (Table II). They
are naturally occurring, semi-natural and synthetic
products, some of them combining two or more
active principles to improve the efficacy. Most of
these belong to the flavonoid family; 600- 800 of
these substances have been identified and grouped
by Geissman and Hinreiner under the name of
flavonoids, plant polyphenols containing a flavone
chemical structure, which in 1955 were given the
name “bioflavonoids” by the New York Academy of
Sciences (164). Their mechanisms of action vary,
but their main property is activation of venous and
lymph return.
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Table III – CO5 vasoprotectors
CEAP classification now means that the same
scoring system can be used for the clinical picture
CO5 B Anti-varicose
CO5 C Capillary
before and after treatment. The symptoms, signs and
treatment
protecting substances
quality of life should all be taken into consideration.
Efficacy on the different outcomes can be
CO5 BA Preparations
obtained using drugs with different chemical
CO5 CA Bioflavonoids
containing heparin for
structures but the same clinical indications. The
topical use
ATC classifications define phlebotrophic drugs as
“vasoprotectors”, and makes a distinction between
CO5 CX Other capillary
topical treatments for varicose veins and “capillary
protecting substances
protective substances”, mainly bioflavonoids (Table
III).
The clinical efficacy on the symptoms (feeling
of heaviness, pain, paresthesia, heat and burning
Phlebotrophic drugs are widely prescribed and
sensations, night cramps, etc.) has long been
marketed in Italy, France, Germany and most of
confirmed by Level III, IV and V evidence, but
Europe but are less used in English-speaking and
there are now Level I and II trials on specific drugs.
Scandinavian countries, presumably because of the
For the bioflavonoids double-blind, randomised
scarcity of published data.
trials have used diosmin-hesperidin (172,173),
With new research
troxerutin (174); rutoside (175); escin (176);
methods this should change.
on
bilberry anthocyanosides (164); and synthetic
physiological parameters such as venous tone,
calcium deobesilate (177). Phlebotrophic action has
venous hemodynamics, capillary permeability and
been demonstrated in pharmaceutical classes other
lymph drainage can be evaluated with a range of
than the flavonoids, such as Ruscus aculeatus (178)
diagnostic procedures, preferably non-invasive (1).
and Centella asiatica (179).
The
effects
of
phlebotrophic
drugs
However, the main tool for assessing the clinical
Various protective agents have been shown to
effects of a phlebotrophic drug is a well-conducted
have clinical efficacy on the main sign, edema,
clinical trial satisfactorily meeting clinical, scientific
acting
and ethical requirements (171). The trial must be
endothelial permeability, reducing the release of
randomised, possibly double-blind, and strong
lysosomal enzymes and inflammatory substances,
enough to at least attempt to answer firm questions
inhibiting free radicals and reducing white cell
regarding the patient’s state of health. Having the
adhesion (158,180,181).
38
ACTA PHLEBOLOGICA
on
the
microcirculation
by
lowering
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
A surprising improvement in quality of life after
Among
the
vasodilators,
the
effects
of
a dose of 1g of micronised diosmin-hesperidin was
pentoxifyllin have been well documented (195,196)
observed in a study of 934 patients with CVI (182).
as has prostaglandin E1 (197) for the treatment of
This improvement was seen in all areas of life,
ulcers.
physical, psychological and relational.
aggregation with aspirin is as coadjuvant treatment
In the last ten years the relationship between
The only indication for platelet anti-
for healing ulcers in CVI (198).
macro- and microcirculation in the more severe
types of CVI has become clearer; it was already
clear that the relationship between reflux and venous
hypertension was a factor in capillary damage
(183,184). Much basic research, and some studies in
man,
have
phlebotrophic
confirmed
drugs,
the
effect
particularly
of
some
micronised
diosmin-hesperidin, on microcirculations that have
been impaired by CVI. (170,182,185-187).
In the light of these findings a series of drugs
have
been
introduced
into
clinical
practice;
however, their clinical usefulness has not always
been confirmed in enough clinical trials of sufficient
power. These drugs are used as coadjuvants in
severe CVI (CEAP Stages 4/5/6) and are listed in
the ATC classification as BO1, Anti-thrombotics,
and in some cases as CO4/CO1E, Vasodilators, for
their action on the altered endothelium and blood
flow patterns, for their action on microthrombi and
their oxygen barrier effect.
The effect of the fibrinolytic enzyme, urokinase,
is documented in two papers (188,189); the
glycosaminoglycans
such
as
sulodexide
have
profibrinolytic activity (190) as does heparan
sulphate (191), and defibrotide (192); but the utility
of stanozolol is considered fairly limited (193,194).
Vol. 1 – Suppl. 1 to No. 1
ACTA PHLEBOLOGICA
39
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
advantageous effects of an exercise schedule on the
Recommendations:
macro- and micro-circulation (202).
There is ample evidence in favor of treating CVI
Manual
ulcers with phlebotrophic drugs when surgery is not
(lymphodrainage)
venous-lymphatic
drainage
indicated, not possible or can be flanked by
are
One of the most widespread and popular
indicated for subjective and functional symptoms of
massage treatment methods for all forms of venous
CVI (fatigue, night cramps, restless legs, heaviness,
and lymphatic stasis, manual lymphatic drainage,
tension) and edema. Grade A
was introduced by E. Vodder in 1936 (203).
coadjuvant
therapy.
Phlebotrophic
drugs
Current usage was codified by Leduc (204) and the
Vodder school (205). It is also indicated for CVI
(206,207).
PHYSIOTHERAPY
Vodder’s concept of mechanical action is based
Patients with chronic venous and lymphatic
on the harmonic displacement of fluids and
insufficiency should generally be advised on
interstitial solutes through the lymphatic capillaries
appropriate lifestyle habits (199). Nowadays, the
towards the ganglia or main drainage areas. The
press publishes a large amount of dietary and health
massage must be rhythmic and smooth and must not
advice, particularly as regards prevention. General
exceed the physiological drainage capacity of the
practitioners and specialists should dedicate a part of
tissues.
the consultation to giving their patients advice on
anatomical area as a basis for deciding the amount
this subject, taking time to convince them. There is
of
plenty of easily accessible explanatory literature and
compression.
It is important to evaluate the overall
strength
and
coordination
during manual
record forms, and the doctor can personalise these to
The patient should enjoy immediate relief of the
motivate the patient, by underlining the important
symptoms if the technique is carried out properly;
information or adding extra advice.
this will obviously depend on the experience and the
The correct amount of physical activities should
manual skill of the person doing the massage.
be prescribed, with advice on good posture, and the
Results are shown by the immediate reduction in the
contraindications outlined (200,201). Clinical and
circumference of the limb and can be checked using
phlebodynamic
indirect lymphoscintigraphy.
testing,
plethysmography,
percutaneous oxygen pressure all demonstrate the
In Germany physiotherapy for lymphedema
based on lymphodrainage is termed KPE (Komplexe
40
ACTA PHLEBOLOGICA
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Physikalische Entstauungstherapie) which can be
as
translated
“multi-factor
- hydrostatic pressure
decongesting
- active and/or passive movement
physiotherapy treatment” (208).
2) specific action, meaning the therapeutic action
related to the chemico-physical characteristics of the
water:
- mineral salts
Recommendations:
- trace elements
Recent clinical and instrumental studies confirm the
- heat
utility of healthy lifestyle habits, physiotherapy and
- concentration
manual lymphodrainage. Grade C
Although from the physical viewpoint the use of
any type of mineral water can be beneficial,
chemically there are only certain types of water
which are specifically indicated for treatment and
MINERAL WATER THERAPY
rehabilitation in chronic venous and lymphatic
The beneficial action of water on venous and
insufficiency (Table IV)
lymphatic stasis in the limbs has been noticed and is
used empirically by the patients
(209,210).
themselves
However, the wide variety of forms of
this treatment means that precise indications and
Table IV
and
Mineral waters indicated in angiology
used
for
prevention,
treatment
and
rehabilitation in venous and lymphatic insufficiency.
“dosage” recommendations are needed to establish
Bromide salts
contraindications and avoid complications. In
Fluid removal from the
edematous tissue
general, home, sea or spa treatments are based on
the effects of hydrostatic pressure, and the
Sulphur
temperature of the bath, while the “medicinal”
Ferruginous arsenicals Tonic, stimulant,
anti-stress
effects are provided by the salts in the water (211).
The
therapeutic
effect
is
achieved
by
two
Calcium sulphate
Venous contractility
stimulant
mechanisms:
Radioactive
Sedative, analgesic,
antispasmodic
1) aspecific or hydrotherapeutic action, given
by the physical properties of the water:
Anti-inflammatory
Carbonic
Tonic
- temperature
Vol. 1 – Suppl. 1 to No. 1
ACTA PHLEBOLOGICA
41
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Many patients walk around for months, or even
Patients can have mineral water treatments at
years,
with
ulcers
treated
only
with
local
any time during the year. If possible, they should
medication, with no effort being made to cure the
have two cycles a year, preferably in autumn and
venous insufficiency causing them (13).
spring, with at least three months’ interval. The
treatment should last at least three weeks for the
Appearance of venous ulcers
patient to gain the full effect, and less than two
weeks is not worth while (212,213).
Venous ulcers of the leg usually present as an
irregular area of loss of skin, the base covered with a
yellow
exudate,
with
well-defined
margins,
surrounded with erythematous, hyperpigmented or
liposclerotic skin. The ulcers vary in size and site,
Recommendations:
but in patients with varicose veins they are usually
Controlled trials have shown that mineral water
seen in the medial region of the lower third of the
treatment for CVI, carried out in a suitable place and
leg (218).
with suitable methods, is effective. Grade B
the leg is often associated with small saphenous vein
A venous ulcer in the lateral portion of
insufficiency (Bass, 1997).
ref.no ???
Patients with venous ulcers may suffer intense
pain even though there is no infection. The pain is
TREATMENT OF VENOUS ULCERS
worse when they are upright and relieved when the
leg is elevated (219).
Introduction
Treatment
Epidemiological studies done in the 1980’s showed
that 1-2% of the adult population suffer from leg
Venous ulcer treatment is based on an
ulcers (10, 214). Although the etiological factors are
understanding
fairly varied, most patients with leg ulcers have
mechanisms involved in producing the ulcer. These
venous disease (215,216).
mechanisms are not exclusively concerned with
CVI, although it has received less attention than
macrovascular hemodynamics, but involve the
chronic arterial insufficiency (CAI), affects ten
microcirculation and endothelium too (220, 1).
times as many adults (217). Consequently, its
Since the venous ulcer is a manifestation of a
treatment is neglected or completely inadequate.
chronic condition with slow repair and a tendency to
42
ACTA PHLEBOLOGICA
of
the
physiopathological
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
recur, therapy must aim not only at curing the ulcer
function,
pain
but, above all, at preventing it recurring (221). At
superinfections
relief,
and
and
management
concomitant
of
diseases.
the same time the patient’s mental attitude must be
Fibrinolytic agents or substances that favor
improved, either so as to convince them to enter and
fibrinolysis, hydroxyrutosides (223,224, Wright,
comply with a treatment program or to improve their
1991 ref.no ?), micronised diosmin-hesperidin
quality of life (3).
(225,226), prostaglandin E1 (Beitner, 1980; 197) and
Treatment of a venous ulcer can involve one or
more of the following (13):
pentoxifyllin (227) are widely used.
As there have been few high-level clinical trials
- basic treatment;
on support drug therapy in patients with venous
- pharmacological treatment;
ulcers, it is still debated how effective some of these
- compression;
drugs are for curing these lesions. However, the
- topical medication;
methodological limitations of the past have been
- surgery;
overcome in recent trials, at least in trials of certain
- sclerotherapy;
bioflavonoids
- other therapies;
elastocompression (225,226).
in
combination
with
- general measures.
COMPRESSION
BASIC TREATMENT
All
patients
with
venous
ulcers
require
The basic treatment must obey the general rule
compressive treatment. Whatever treatment is given
of considering the patient as a whole and not just
for the venous ulcer must always be combined with
focusing on treating the ulcer (222). Patients’
compression. The patient must also be able to move
lifestyles are extremely important: their ability to
about so as to obtain maximum benefit from the
walk, their work, whether they are obese, diabetic or
compression (228).
have other concomitant diseases (13).
Compression stimulates the venous flow,
reduces the pathological reflux when the patient is
PHARMACOLOGICAL TREATMENT
walking (Partsch, 1990 ref.no ?), improves the
microcirculation and boosts lymphatic drainage
The
main
hemoconcentration,
targets
are
increased
venous
tone,
(161). The chronic edema and the ulcer exudate are
capillary
reduced and the lesion not only regresses sooner but
permeability, edema, reduced fibrinolytic activity,
is also less likely to recur.
increased plasma fibrinogen, anomalies in leucocyte
Vol. 1 – Suppl. 1 to No. 1
ACTA PHLEBOLOGICA
43
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Compressive therapy can be done with elastic
easier to put on two Class I stockings (20-30 mm Hg
bandages or stockings (219,229). In the acute phase,
at the ankle), one on top of the other (229). For bed-
inelastic
ridden patients, or those who walk very little, anti-
bandages,
zinc
oxide
bandages,
or
multilayer bandaging are the most effective type of
thrombus
stockings
should
compression. A multilayer bandage can be left in
Intermittent
place for at least a week, but at the start of
beneficial in selected cases (233).
pneumatic
be
considered.
compression
may
be
treatment, until the exudate and the edema have
Recurrence may occur after healing, in the short
subsided, it is advisable to remove and reapply the
or longer term, in 20-70% of patients (234,14).
bandaging more often.
Good healing has been
Recurrence is linked to a variety of risk factors, but
reported using four-layer compressive bandaging
particularly to the persistence of the hemodynamic
(230,231) which seem to give effective compression
changes
even when applied by unskilled personnel (232).
compression
However, at the moment, there is no agreement on
compression also depends on how much the patient
whether the multilayer system is more effective than
moves; patients must be encouraged to walk and
two layers.
take regular physical exercise and rehabilitation
The bandage must give a resting pressure of at
and
inadequate
(230,154).
or
unacceptable
The
success
of
therapy (228,235).
least 20-30 mm Hg at the ankle and the lower third
of the leg with gradually less compression towards
TOPICAL MEDICATIONS
the upper third of the leg and thigh (144,13).
In patients with moderate occlusive arterial
When planning topical treatment for patients
disease, with an ankle-brachial index (ABI) between
with venous ulcers it is important to take account of
0.6 and 0.8, bandaging must be done very carefully.
clinical observations such as the presence of dead
Inelastic material must be used, so as to exert low
tissue, exudates, infections and the state of the skin
resting pressure. If the arterial insufficiency is very
surrounding the ulcer (229).
severe, with an ABI below 0.6, any type of
bandaging is contraindicated (13).
Topical treatment for venous ulcers is designed
to
keep
the
lesion
clean,
to
preserve
the
Compression with elastic stockings helps
microenvironment, protect the lesion from infectious
maintain the results gained from treating the ulcers
agents and stimulate cell repair mechanisms (219).
and to prevent recurrence. Generally, they are Class
Ideal medications should meet the following criteria:
II compression stockings (30-40 mm Hg at the
- they should not adhere, and should leave no
ankle) or Class III (40-50 mm Hg). Elderly patients
residues on the ulcer
or people with joint mobility problems may find it
44
ACTA PHLEBOLOGICA
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
- they should keep the surface of the ulcer
growth factor has been proposed (236) and can
moist
administered by infiltration (237).
- they should be impermeable to liquids, but
The exudate from infected ulcers should be
allow for gaseous exchange
cultured and systemic antibiotics started. Topical
- they should create a barrier against bacteria
antibodies are not generally indicated as they can
and fungi
facilitate the onset of contact dermatitis (238,239).
- they should stimulate granulation tissue
A prospective trial showed that patients with venous
- they should give some pain relief
ulcers treated with silver sulfadiazine emulsion
- they should be affordable.
combined with elastocompression healed sooner
than the group treated with compression alone (240).
At the present time, despite the wide variety
As healing progresses and there is little secretion
of medications available, none of them are ideal and
and the ulcer becomes superficial, the medication
it is not possible to draw up rigorous protocols valid
can be changed to a so-called “biological”
for the treatment of all venous ulcers (222).
treatment: a thin cellulose or hyaluronic acid-based
Experience shows that any product may be effective
film, which protects the wound, stops the ulcer
initially, but the benefits will decrease over time and
getting infected and gives good support for the
another product may eventually heal the ulcer.
migration and proliferation of basal epidermal cells
Consequently, the physician’s attitude must be
while maintaining a good level of moisture so the
dynamic, taking account of the different phases of
lesion does not dry out. (219).
natural healing: necrotic, fibrinous, exudative,
infectious,
cleansing,
granulation,
re-
SURGERY
epithelialization.
In years past the only treatment was rigid
Surgery should not be considered as the only
compressive bandaging and local medication with a
treatment or as an alternative treatment for venous
few cleansing and/or disinfecting products. Now,
ulcers, but as a complement to conservative therapy.
however, there are many treatments available with a
Surgery for ulcers has two fundamental objectives:
variety of indications for the different stages of the
-
correcting the hemodynamic changes
disease. There are occlusive and semi-occlusive
-
covering the ulcer with grafted skin to
medications, absorbents, medications based on
reduce the healing time.
carboxymethyl cellulose, alginates, polyurethane,
This procedure must be preceded by detailed
collagen, fibrin glue, chitosan; they come as pastes,
morphological and hemodynamic study of the
granules, foams and gels.
Vol. 1 – Suppl. 1 to No. 1
Local application of
ACTA PHLEBOLOGICA
45
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
superficial and deep venous systems and by the
- allograft
usual diagnostic procedures (31,241).
of
human
keratinocytes
cultured in vitro (247)
It is commonly considered that surgery of the
- free flap grafts of venous sections with
superficial venous system in patients with varicose
valves, preceded by ulcerectomy and ligature of the
ulcers achieves the best results, reducing healing
incompetent perforating veins (248).
time and delaying recurrences, especially if there is
- “shave therapy”, i.e. ulcerectomy, removal
no changes in the deep vein system (222). Surgery
of the lipodermatosclerotic tissue and meshed grafts
for post-thrombotic ulcers is less satisfactory (242).
(249).
Surgery on perforating veins in CVI has
The meshed grafting technique gives the best
improved recently with the development of the
results, whilst human keratinocyte allografts and
endoscopic technique for tying the subfascial veins
human skin substitutes are under critical review,
(36). Although the early results are excellent, the
with no data as yet to show the effect on recurrence
failure and recurrence rates are between 2.5 and
(250).
22% (86,243,244). One technical limitation is the
difficulty of access to perimalleolar perforating
SCLEROTHERAPY
veins. It has been observed that 50% of incompetent
perforating veins within 10 cm of the ground,
Sclerotherapy
combined
with
compression
identified pre-operatively with Duplex scanning,
treatment is indicated in selected patients with
cannot be treated with the endoscopic technique.
superficial venous system insufficiency, particularly
(243).
if there are only short segments with reflux from
Insufficiency in superficial and perforating
incompetent perforating veins (251), even if there is
veins must always be fully corrected before
an open ulcer (252). Sclerotherapy with ultrasound
considering any interventions on the deep venous
guidance was proposed in one study (109).
circulation.
Valvuloplasty, valves and venous grafts must be
OTHER TREATMENTS
used as a last resort. These procedures are still in the
These include
development phase, and can only be considered in
-
hyperbaric oxygen;
specialist centers and during controlled clinical trials
-
ozone therapy;
(13).
- electro-ionotherapy;
46
Skin grafts are possible, using various methods:
- vacuum therapy;
- meshed split skin grafting (243)
- polarised light;
- pinch grafting (246)
- laser therapy.
ACTA PHLEBOLOGICA
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
The international literature calls for the
These are experimental treatments with limited
establishment of special units dedicated to the study
caselists, and as yet there is no full documentation
and cure of ulcers of the legs.
These would be
for the results and follow-up.
responsible for home care and rehabilitation
services, with a view to improving the quality of the
GENERAL MEASURES
services offered, keeping down costs, and - last but
not least – ensuring a better quality of life for the
Patients with venous ulcers must be advised to
patient.
keep as close to their ideal body weight as possible.
Regular walks on flat ground, 2-3 times a day for at
least 30 minutes, should be encouraged.
Patients
should avoid standing for long periods.
Recommendations:
They
should also position themselves occasionally during
Conservative therapy has an important role to play
the day with their legs higher than the level of their
in the first instance but does not prevent long-term
heart, and sleep with their legs slightly raised.
recurrence unless it is supported, in many cases, by
Manual lymphatic drainage can be considered
for
patients
with
edema
caused
by
surgical correction of the hemodynamic problems.
CVI.
Surgery gives good results only in cases with
Physiotherapy can improve joint mobility of the
isolated insufficiency of the venous system. Grade
ankles.
B
Compressive therapy, when applied correctly, will
Treatment for venous ulcers is a very old
problem, much discussed but not resolved – as we
cure and prevent the recurrence of ulcers.
Grade
A.
have seen - because these lesions are slow to heal
and quick to return.
Many clinical trials have been published but
VENOUS MALFORMATIONS
they are too selective to be representative of the
general population. They usually only report short-
Venous malformations (VM) are the most
term cure rates, without giving longer-term data on
widespread vascular anomalies in the general
recurrences. To supply reliable clinical evidence and
population
validate the techniques still under investigation more
malformations involve various morphological and
rigorous methods and investigation standards are
functional alterations in the central or peripheral
needed.
venous system.
Vol. 1 – Suppl. 1 to No. 1
ACTA PHLEBOLOGICA
(253-256).
These
congenital
47
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
The pathogenesis of VM appears to be linked to
posture and walking), sometimes with disabling
genetic anomalies in various biochemical mediators
effects.
(e.g. angiopoietin) and the membrane receptors that
Circulation complications take the form of
regulate the interactions between endothelial and
venous stasis, peripheral forms leading to CVI, and
smooth muscle cells in the end stages of
loco-regional
angiogenesis. The resulting maturation defect leads
thrombosis and the possible depletion of coagulation
to the formation of anomalous veins with a
factors (Table V).
hypercoagulation
with
localised
monolayer of flat endothelial cells on the walls, but
Table V – Physiopathological effects of venous
no real smooth muscular tunic.
VM mostly presents in the sporadic form in
malformations
subjects with no family history, but there are also
descriptions of hereditary and familial forms. In the
Esthetic
majority of cases there is an isolated malformation,
but multifocal and even systemic disseminated
Superficial blemishes
Skeletal deformations
Psychological
forms are also seen.
Patient
Family
VM are usually located on the skin and mucous
Functional
Motor deficiencies:
membranes, but they are often intramuscular or even
swallowing
intra-articular, and any organ may be involved.
speech
Distribution by site shows a marked prevalence of
respiration
peripheral VM, particularly in the lower limbs, and
grasping
cranio-facial VM, particularly in the temporo-
walking
masseteric, fronto-palpebral and lingual and labial
sensory disorders: sight
regions. Other, less common, locations are the chest,
abdomen and genitals.
VM can lead to multiple secondary effects or
hearing
Hemodynamic
Chronic venous stasis
Coagulation
Localised thrombosis
complications. The most striking are esthetic and
Consumption coagulopathy
psychological, though these are by far from the only
ones, and certainly not the most important. VM in
The natural history of VM tends to vary.
the cranio-facial area can cause serious functional
Generally, these malformations are evident from
disorders, with problems in swallowing, speech,
birth but sometimes they only become detectable
respiration, sight or hearing); in peripheral regions
later, during childhood or adolescence. In most
they can cause problems disorders in grasping,
cases, the maximum development is during puberty,
48
ACTA PHLEBOLOGICA
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
with a marked increase in size, while later the
Intramuscular VM are more rare but are now
malformation expands much more slowly, linked to
being seen increasingly frequently. Generally these
the progressive slackening of surrounding tissues.
malformations look like lacunar veins; they may be
The hemodynamic repercussions of the venous
large and extensive, and lie between the large
anomalies can become clinically evident and get
muscle bundles, for instance in the quadriceps
progressively worse over the years, even if there is
femoris muscle or the brachial biceps.
no real increase in the malformation.
The intra-articular form is the least frequent
Table VI gives a schematic classification of
and the hardest to diagnose clinically; large venous
simple and complex VM, based on their anatomical
lacunae may be located inside a joint, causing
and pathological criteria.
gradual synovial erosion with degenerative lesions
in the joint head as is typically observed in the
Table VI – Anatomical and clinical classification of
femoral-tibial joint.
venous malformations (VM)
COMPLEX VENOUS MALFORMATIONS
Simple VM
Complex VM
Subcutaneous form
Intramuscular form
Complex VM involve a combination of
Intra-articular form
congenital venous anomalies such as hypoplasia or
Venous hypo/aplasia
agenesis of the superficial and/or deep venous
Congenital valvular
system,
incompetence
persistence of embryonal trunk veins such as the
Persistent embryonal veins
marginal vein.
primary
valvular
incontinence,
and
In the hypo/aplastic form there may be
complete agenesis, or varying degrees of hypoplasia
SIMPLE VENOUS MALFORMATIONS
and reduction in caliber in one or more segments of
In simple forms the anomalous veins may be
the superficial and/or deep venous systems of a
abnormally dilated, with very thin walls consisting
limb. One of the most frequent complex VM is
of a single layer of endothelial cells, and a markedly
agenesis of the poplito-femoral and/or the femoral-
hypoplastic smooth muscular coat (lacunar veins).
iliac tract, with compensatory hypertrophy of the
Subcutaneous VM are the most frequent and are
usually
lacunar
or
reticular
veins
in
the
subcutaneous adipose tissue, at variable depth but
greater saphenous vein which,
in some cases,
continues, typically in a large suprapubic vein crossover confluent with the contralateral iliac axis.
often over the fascial layer.
Vol. 1 – Suppl. 1 to No. 1
ACTA PHLEBOLOGICA
49
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
In congenital valvular incontinence
there is
- Inferior gluteal vein
primary deep vein insufficiency, caused by complete
- Internal iliac vein
atresia of the cusps of one of the venous valves or
- Common iliac vein
by dysplastic changes producing a mechanical
- Multiple confluences
defect in valve flap closure. These anomalies are
mostly found in the superficial femoral vein, but can
Clinical picture
also involve the deep femoral vein, the common
femoral vein and the internal iliac vein.
The signs and symptoms of VM widely:
In the form with persisting embryonal veins
differences are seen in the site, the depth, the
there are anomalous, large-caliber venous trunks
extension and the extent of anatomical and
which develop in the early stages of vasculogenesis
hemodynamic changes.
and normally regress during the later phase of
surface are visible as a subcutaneous swelling of
modeling of the vascular tree. The most common
variable size and form, soft and elastic in
embryonal veins are the sciatic and marginal veins.
consistency, collapsing easily with pressure, covered
The sciatic vein presents as a large trunk continuous
with bluish or purple-colored skin of normal
with the popliteal vein which runs posteriorly in the
temperature.
thigh and terminates in the pelvis, meeting the
pulse but typically expand in the anti-gravity
ipsilateral iliac. The marginal vein is a large-caliber
position; this sign is very useful for diagnosis and
venous
must be checked carefully.
collector
originating
in
the
external
Malformed veins on the
The veins do not have an intrinsic
On palpation there are
malleolar region and running along the lateral
small hard nodules: these are “phleboliths” – venous
surface of the lower limb for varying distances,
stones - caused by local thrombosis.
draining into various vessels in the deep venous
Intramuscular or intra-articular VM are less
system. This has been illustrated in a classification
evident on objective examination, particularly if
of the multiple variants of this vein’s course (Table
they are small, as they are deep and are often
VII).
covered by healthy skin. However, careful clinical
observation will generally show a typical asymmetry
Table VII Classification of the outlets of the
of
marginal vein
contralateral area. This is accentuated when the
- Superficial femoral vein
- Deep femoral vein
50
the
anatomical
region
compared
to
the
patient is lying down.
Embryonal veins present as twisted and
- Common femoral vein
irregular ectatic venous trunks which extend into the
- External iliac vein
acral regions for varying distances in the direction of
ACTA PHLEBOLOGICA
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
the root of the limb. In hypo/aplasia of the deep
venous
circulation
or
congenital
valvular
Diagnosis
incontinence, there will be clinical signs of chronic
venous hypertension: edema, secondary varicose
Venous malformations are generally diagnosed by
veins, lipodermatosclerosis and stasis ulcers.
clinical examination.
Skeletal
and
soft
tissue
changes,
with
hypertrophy or hypotrophy, are less frequent than
Table VIII – Diagnostic approach to patients with
with venous-arterial malformations, but may be
venous malformations
present, particularly in the peripheral forms.
VM are frequently associated with anomalies in
Cranio-facial venous Cranial X-ray
the lymph system, and signs of lymphostasis are
malformations
frequent.
Direct phlebography Cranio-facial MR
In
the
mixed
venous-capillary
form
subcutaneous VM are often associated with flat
Colour echoDoppler
Peripheral venous
Comparative limb
malformations
X-ray
superficial angiomas.
Colour echoDoppler
The triad of a complex peripheral VM,
Descending phlebography
cutaneous capillary malformation and skeletal and
Ascending phlebography
soft tissue hypertrophy in a limb is known as the
Direct phlebography
Klippel-Trenaunay syndrome. The Proteo syndrome
MR or CT scan of the limb
has multifocal capillary-venous and lymph system
malformations with anomalies of the muscles and
However, every patient should also have a
skeleton and the peripheral nerves. It causes extreme
thorough preoperative clinical and instrumental
hypertrophy and deformation of the affected limb.
diagnostic evaluation, as the treatment indications
Maffucci syndrome is the combination of
a
are closely correlated with the morphological and
superficial VM and multiple enchondromatosis of
functional characteristics of the VM. The elements
the upper or lower extremities, leading to marked
investigated will include the site and the anatomical
skeletal deformations with shortening of the limb
relationships,
and possible later chondrosarcoma. The presence of
hemodynamic effects, patency and competence of
multiple subcutaneous VM may be an element in the
the superficial and deep venous systems.
rare
Bean
syndrome,
by
extent
and
dimensions,
the
A rigorously standardised diagnostic protocol
simultaneous presence of disseminated VM of the
must be employed based on the following
gastrointestinal tract.
instrumental examinations: standard X-ray, colour
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characterised
the
ACTA PHLEBOLOGICA
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
echoDoppler,
magnetic
computerised
resonance
tomography
imaging
(CT),
(MRI)
and
phlebography (Table VIII).
malformation, as these all give complementary
information.
The ascending phase explores the patency and
Standard X-rays show the indirect signs of VM
conformation of the main venous axes, showing up
such as phleboliths and any associated skeletal
any hypo/aplasia with great diagnostic accuracy.
dysplasia
The descending phase gives a picture of valve
and
size
abnormalities.
Colour
echoDoppler is the preliminary examination, for
competence,
studying the extent of the VM, the patency and
insufficiency; the degree can be assessed on the
competence of the superficial and deep venous
basis of the retrograde opacity in the deep venous
systems, the morphology and functional status of the
system.
venous valves and to exclude the presence of
arterio-venous fistulas.
showing
any
primary
venous
These investigations are completed with a
selective hemodynamic study by direct injection,
CT and MRI scans permit an accurate definition
which is vital for the examination of lacunar VM
of the extent of the VM and their anatomical
with low-velocity flow, or for embryonal veins
relationships with internal organs and the musculo-
which can be visualised throughout their length as
skeletal
far as the confluence.
structures,
particularly
malformations are deep.
when
the
The diagnosis will be
By using tourniquets and hemostatic cuffs or
completed with a phlebography examination. This is
other systems of selective compression, isolated
indispensable to obtain a complete morphological
parts of the venous circulation can be examined in
and hemodynamic picture of the malformations and
all phlebography phases.
the entire superficial and deep venous system. The
examination should be done in the ascending and
descending phases and with direct puncture of the
52
ACTA PHLEBOLOGICA
September 2000
DIAGNOSIS
AND TREATMENT
GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Table IX – Treatment choices for patients
with venous
malformations
Cranio-facial venous malformations
Simple subcutaneous peripheral venous malformations
Simple intramuscular peripheral venous malformations
Simple intraosseous peripheral venous malformations
Complex peripheral venous malformations with hypoplasia
Complex peripheral venous malformations with
valvular incompetence
Complex peripheral venous malformations with
embryonal veins
This
procedure
can
even
be
Percutaneous sclerotherapy (++)
Guided sclerotherapy (++++)
Surgery (+)
Percutaneous sclerotherapy (+++)
Guided sclerotherapy (+++)
Surgery (++)
Percutaneous sclerotherapy (+)
Guided sclerotherapy (++++)
Guided sclerotherapy (++++)
Abstention (+++)
Surgery (+)
Surgery (++)
Percutaneous sclerotherapy (+++)
Guided sclerotherapy (++)
Surgery (+++)
done
therapeutic program so that surgical procedures
intraoperatively, so that the VM can be checked in
and/or percutaneous treatments can be combined as
real time during sceleroembolising treatment. It can
most appropriate for each patient.
also be used to give an immediate postoperative
check on the results.
The indications and the strength of the
recommendations for the various treatment options
in the different forms of VM are summarized in
Table IX.
Treatment
____________________________________
Treating VM poses serious problems for the
Table IX – Therapeutic options for venous
vascular surgeon as these are often extremely
malformations (VM)
complex malformations, appearing in babies or
Cranio-facial VM
young children, with very serious hemodynamic,
- Percutaneous sclerotherapy (++)
functional and esthetic implications. The aims of
- Phlebo-guided sclerotherapy (++++)
treatment are the partial or complete regression of
- Surgery (+)
the malformation, reduction or disappearance of the
Simple subcutaneous peripheral VM
signs
- Percutaneous sclerotherapy (+++)
of
venous
insufficiency,
functional
rehabilitation of the limb, elimination or reduction
- Phlebo-guided sclerotherapy (+++)
of unattractive varices.
- Surgery (++)
A complete preoperative diagnostic evaluation
Simple intramuscular peripheral VM
is absolutely vital before any treatment is decided;
- Percutaneous sclerotherapy (+)
the instrumental findings must guide each individual
- Phlebo-guided sclerotherapy (++++)
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
Simple intra-articular peripheral VM
The dosage of the sclerosing agent will be
- Phlebo-guided sclerotherapy (++++)
established in proportion to the size of the
Complex peripheral VM with hypo/aplasia
malformed veins, up to a maximum dose of 2 ml/kg
- Wait and see (+++)
body weight.
- Surgery (+)
The sclerotherapy technique must obviously be
Complex peripheral VM with valvular incontinence
extremely rigorous because accidental injection of
- Surgery (++)
the sclerosing mixture outside the vein can provoke
Complex peripheral VM with embryonal vein
many
- Surgery (+++)
thrombophlebitis, cutaneous necrosis, granuloma,
- Phlebo-guided sclerotherapy (++)
neurological damage.
- Percutaneous sclerotherapy (+)
effect is loco-regional inflammation/edema, varying
____________________________________
in size which will disappear in a few weeks; it can
serious
complications,
such
as
A normal, reversible side
be treated, if necessary, with a steroidal antiDirect percutaneous sclerotherapy can be done on
inflammatory drug.
isolated, superficial, small VM. If they are more
Surgery plays a fundamental role in the
extensive and deeper it is better to do the
complex overall treatment strategy for VM. The
sclerotherapy under radioscopic guidance, using the
most common surgical procedure is to strip lacunar
direct injection phlebography technique.
This
or reticular malformed veins in the lower limbs; this
allows close control of the injection site and the
should preferably be done by a micro-invasive
diffusion
technique, through micro-incisions in the skin and
of
the
sclerosing
mixture,
giving
immediate confirmation of the results.
using special phlebectomy hooks.
Various sclerosing mixtures are used. The
choice
morphological
only therapeutic procedure is surgical removal. This
characteristics, anatomical site and extent of the
must also be done with the least invasive technique
malformation. For spider veins and/or small-caliber
possible.
VM, particularly on the lips and tongue, a 2-3%
along the outer surface of the limb, but nowadays
polydocanol solution is recommended. For large-
only minimal skin incisions are needed, so the
caliber, extensive VM (lacunar veins), which are
outcome is esthetically more acceptable. Detailed
frequently found in the temporo-mandibular area, a
preoperative mapping must be done on the
more powerful sclerosing agent is called for, such as
embryonal vein, and when feasible, mini-strippers
95% ethanol and Ethibloc.
can be used.
54
will
depend
on
the
For a persisting embryonal venous trunk the
ACTA PHLEBOLOGICA
In the past large incisions were made
September 2000
DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
When
dealing
incompetence,
with
and
congenital
preoperative
valvular
fewer esthetic and functional implications, whereas
ultrasound
surgery, being more radical, is used more for the
examination indicates the presence of dysplastic
peripheral forms.
valvular flaps, the venous valves can be surgically
The complexity and size of the VM will have a
reconstructed by external venoplasty with reinforced
directly proportional effect on the choice of surgical
Dacron or PTFE prostheses. The correct positioning
approach. Simple or isolated VM are treated by
of the prosthetic band – of the right caliber – will
elective intravascular percutaneous sclerotherapy
restore valve competence by drawing the dysplastic
under venographic guidance. Complex VM call for
flaps closer together, while maintaining the patency
corrective and/or reconstructive surgery, depending
of the veins.
on the anatomical and hemodynamic changes
For segmentary hypoplasia of the deep venous
present.
circulation secondary to extrinsic compression from
In the majority of cases, combined therapy is
an abnormal fibrous muscle band, as is often seen
the preferred option. Percutaneous and surgical
in the popliteal cavity, a decompression procedure
treatment
can be done to facilitate development of the
morphological and functional results. Ligature and
hypoplastic venous structures.
stripping the malformed veins can be combined with
In
cases
of
deep
vein
offers
the
best
clinical,
with
preliminary or intraoperative sclerosing treatment,
compensatory hypertrophy of superficial veins such
so that minimally invasive techniques can be
as the greater saphenous vein and its collaterals,
employed to remove moderately sized dysplastic
surgical removal of the malformed veins is
lacunar or spider veins.
obviously contra-indicated, as
agenesis
combined
they serve
as
hemodynamic substitutes.
Similarly, after stripping the main trunk of an
embryonal vein the intervention can be completed
To conclude, therefore, the therapeutic strategy
by percutaneous sclerotherapy on the numerous
must be carefully thought out and planned for each
collateral veins, particularly the terminal end near
patient on the basis of the clinical and instrumental
the confluence with the deep venous system.
findings, with particular reference to the site, the
In
conclusion,
surgery
and
percutaneous
morphology and the extent of the VM, and taking
sclerotherapy should not be considered alternatives
account of the architecture and the hemodynamics
but can be usefully combined in the complex and
of the loco-regional venous circulation.
delicate strategies for treating VM. An important
The site of the malformation can be a major
factor in choosing treatment.
In the facial and
point, particularly in cases of extensive VM, is that
numerous
sequential
surgical
operations
or
genital areas sclerotherapy is preferred as it has
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ACTA PHLEBOLOGICA
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DIAGNOSIS AND TREATMENT GUIDELINES FOR CHRONIC VENOUS INSUFFICIENCY
sclerotherapies may be necessary to obtain complete
regression of the malformations.
Specific questionnaires for CVI (CVIQ1 and
CVIQ2) have been used since 1992, with surprising
results for a disease that has hitherto been so
severely underestimated. CVI has a profoundly
Recommendations:
negative effect on the patient’s daily life and the
In the past, the only treatment option for malformed
results illustrate the impact of CVI on morbidity and
veins was destructive surgery; this was often
the efficacy of drug therapy (260,261).
unsuccessful, gave disappointing esthetic results,
Evaluation of randomised controlled trials on
and the veins often recurred. In recent years
surgery and its effect on QoL is more complicated
intravascular percutaneous sclerotherapy for VM
(262). Trials are still in progress to assess recent
has been much improved and is now widely used.
surgical techniques for CVI such as subfascial
This minimally invasive technique has been reported
endoscopic ligature of the perforating veins (SEPS)
to give the best morphological and functional
and valvuloplasty.
results. It appears to be a valid alternative or useful
complement to surgery, for facial, genital and
peripheral VM. Grade C
Recommendations:
It is vitally important to choose the right time for
surgery, to take account of the patient’s growth, the
The analysis of clinical parameters for evaluating
development
the
of
the
malformation
hemodynamic repercussions.
and
its
Grade C
Quality
of
Life
should
use
standard
psychometric criteria which are reproducible, valid
and acceptable. The Medical Outcomes Study Short
Form Health Survey-36 and the Nottingham Health
Profile (NHP) have proven scientific worth but their
QUALITY OF LIFE
relevance to CVI needs to be confirmed.
There are many reasons for considering
the
Specific measurements are needed to study QoL in
Quality of Life (QoL) as part of the therapeutic
CVI. They must be:
outcome, in CVI like in other diseases (Garrat,
-
workable, valid and responsive,
1993, 256, 1).
The current method of generic
-
practical for checking clinical results,
measuring, considered the standard in the USA and
-
available in a wide variety of languages so they
in Europe, is the Medical Outcomes Study Short
can be used in international trials. Grade C
Form Health Survey – 36 (MOS SF36) (258,259).
56
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September 2000