Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3687_Библиотеки_им_академика_М_И_Перельмана
.pdf
This page intentionally left blank
https://t.me/med1917
CHAPTER
https://t.me/med1917
19
Conventional Sclerotherapy
versus Surgery for Varicose Veins
T.R. CHEATLE
Many clinicians who treat varicose veins will take issue with
the title of this chapter. The two techniques, it will be said,
are complementary, not mutually exclusive, alternatives. In
addition, what about foam sclerotherapy? VNUS closure?
Endovenous laser ablation? Powered phlebectomy? Surely,
with these exciting new treatments becoming available, the
title smacks of a man comparing smoke signals to carrier
pigeons in the age of the telephone.
Of course the two techniques are indeed complementary,
but it is still reasonable to fi nd out which gives the better
results (however one measures “better”) in the average
patient. As far as newer techniques go (many dealt with in
other chapters herein), we do not yet know what the longterm results of treatment will be. And for the average practitioner in many countries, they will not be readily available,
either due to expense, lack of ability to become trained in
them, or a variety of other reasons. Thus for many doctors,
the realistic choice they face in treating patients with varicose veins remains between surgery or conventional sclerotherapy—at least for the time being.
The history of injection sclerotherapy is summarized by
Browse et al.1 The elaboration of the technique and indications for its use were expounded fi rst by Karl Sigg of Basle,
Switzerland,2 and subsequently, and perhaps most infl uentially, by George Fegan of Dublin, Ireland.
Sigg is one of the major fi gures in the development of
compression sclerotherapy. The technique of inserting the
needle with the patient in the standing position but injecting
with the leg horizontal is attributed to him. He also recommended starting sclerotherapy in the most distal varices, as
opposed to Tournay who had recommended starting at the
most proximal point of refl ux. In addition he was among the
fi rst to stress the desirability of graduated compression rather
than uniform compression. For these innovations as much
3
as for his enthusiastic and detailed publications, he is remembered as one of the founders of modern sclerotherapy.
George Fegan’s name has become synonymous with the
use of sclerotherapy in many parts of the world. He makes
the point strongly that the aim of sclerotherapy is not to
cause thrombosis in a varix, but rather to cause an obliterative fi brosis. Histological evidence is adduced to show the
recanalization that occurs when a vein has been merely
thrombosed, compared to the absence of same when fi brous
obliteration has been achieved. This obliteration is obtained
by immediate and continuous compression, sustained for
six weeks. Great importance is laid on the technique of
bandaging.
Fegan’s papers are essentially descriptive and do not
purport to be trials. Clearly, as his results show, he was an
expert and dedicated exponent of the method he developed.
His emphasis on using an “empty vein” technique, the importance he placed on controlling points of refl ux (especially
the Hunterian perforator above the femoral condyle) rather
than simply injecting varices at random, and his bandaging
technique have all formed the basis of most sclerotherapy
done in many parts of the world today.
Stripping the Great Saphenous vein has been practiced
since the description by Keller in 1905,4 and the subsequent
century, it is fair to say, has produced only modest modifi cations of the principles of varicose vein surgery established
before the fi rst world war.
Given that both surgery and sclerotherapy have been
practiced for so long, it is very disappointing that so little
high quality literature exists to compare the two techniques.
Papers on phlebological topics have not always conformed
to the highest standards of scientifi c rigor and have too often
relied on anecdotal or retrospective accounts of outcome.
The number of useful randomized trials comparing the two
The Vein Book
183
All rights of reproduction in any form reserved.
Copyright © 2006, Elsevier Inc.
184 Chapter 19/Conventional Sclerotherapy versus Surgery for Varicose Veins
https://t.me/med1917
methods is very small, and most of these were performed
and published more than a generation ago.
John Hobbs made one of the fi rst attempts to compare in
a scientifi c way the outcome of the two techniques.5 In the
key part of his paper, 500 patients with varicose veins were
randomized to either surgical or injection treatment. The
patients were photographed and classifi ed by severity before
treatment. However, no data are given as to the pathophysiology in these patients, for example, Great or Small Saphenous incompetence. Injection treatment was performed
using Hobbs’ own method, which involves inserting the
needle and injecting with the patient fl at. Three percent
Sodium Tetradecyl (STD) was used, and an average of 11.4
injections per leg were given. The legs were bandaged for
six weeks. A minor fl aw in the study was that those allocated
to surgery were treated by a number of different surgeons,
presumably of differing experience and ability, although
Hobbs states that “most” of the operations were done by
him. The patients were seen and reassessed at six-month
intervals for up to six years, and classifi ed as either cured,
improved, or failed, according to the less favorable view of
either patient or surgeon.
Hobbs found that after one year, patients treated by
sclerotherapy had a better result than those operated upon.
However over subsequent years, this difference disappeared
and was reversed due to increasing numbers of recurrences
seen in the injection group. This was despite intermittent
extra injection treatments given to patients in the sclerotherapy group. By six years, approximately 20% of the surgical group were classifi ed as failures, compared with almost
70% of the sclerotherapy group. Hobbs concluded that
patients with defi nite saphenofemoral or popliteal refl ux
were best served by surgery, whereas those without should
get sclerotherapy; a view that would be accepted widely by
many vascular surgeons practicing today.
Two papers from Chant’s group
6,7
give the results of
another randomized controlled trial in which 115 patients
were treated with compression sclerotherapy and 100 treated
by surgery. Again, we do not know how many had Great or
Small Saphenous incompetence, or neither. Ninety patients
were excluded from the trial because they either had recurrent or trivial veins or had medical or social contraindications, or because they expressed a strong preference for one
form of treatment.
Surgical treatment consisted of saphenofemoral or
saphenopopliteal ligation, stripping of the Great or Small
Saphenous vein, and ligation of any clinically detected perforators. Injection sclerotherapy was performed using
Fegan’s method. Information concerning the number of injections given and the number of sessions used is not given.
The patients were followed up at six months and at yearly
intervals thereafter. The fi rst paper was written when 93%
had achieved a three-year follow-up. Patients were classifi ed
depending on their requirement for further treatment, be it
surgery, sclerotherapy, or stockings. Including those who
declined any treatment after randomization, the authors
found that 25% in the surgical group had required further
treatment compared to 27% in the group treated by compression sclerotherapy. On these results the authors concluded
that the two treatments were equivalent in their effect. They
also made the point that sclerotherapy was often more
acceptable to women with children, as it avoided a disruptive hospital admission, even if several outpatient visits were
required.
In their second paper, the same patients were reviewed,
having now been followed up for a minimum of fi ve years.
At this stage 40% of those initially treated by sclerotherapy
had required some form of retreatment compared to 24.2%
of those treated surgically. Interestingly, the authors found
that difference was principally in older patients; in those
aged less than 35, the two treatments remained equivalent.
The results of this paper indicated a long-term advantage to
surgical treatment, although the scale of the difference in
results is quite small.
In John Seddon’s 1973 paper,8 201 patients with demonstrable incompetence of the saphenous systems and/or
ulceration due to perforator incompetence were studied.
They were divided (presumably randomly, though the
paper does not say this) to receive either surgical treatment
(saphenofemoral disconnection with stripping of the Great
Saphenous vein and perforator ligation) or sclerotherapy
by Fegan’s method. Patients undergoing sclerotherapy were
reviewed every three weeks until treatment was deemed
complete; the average number of injections was not given.
Posttreatment compression was applied using bandages,
though the duration is not stated.
Follow-up was between 12 and 18 months in all cases.
Twenty-nine of the 149 limbs (19%) treated by sclerotherapy
either did not respond to treatment (3) or had residual (19) or
recurrent (7) veins at follow-up. This compares to 25 of 125
limbs treated surgically (20%). Two of the 15 patients with
ulcers in the sclerotherapy group suffered ulcer recurrence,
compared to none of the fi ve treated surgically. A small
number of minor complications occurred in both groups.
The author concludes that the outcome of the two treatment methods is approximately the same. This agrees with
the fi ndings of other studies for the follow-up period
described, but whether that equivalence would have been
maintained over a longer period is a moot point; the studies
of Hobbs and Chant described earlier would suggest not.
Motivated largely by the length of time patients were
staying in hospital following varicose vein surgery (10.5
days), Doran and White
9
designed a trial to compare surgical
treatment to sclerotherapy. Five hundred and two limbs in
331 patients with primary uncomplicated varicose veins
were randomized (by year of birth) to receive either sclerotherapy by Fegan’s method (280 limbs) or conventional surgery (222 limbs). No details of exactly what
Chapter 19/Conventional Sclerotherapy versus Surgery for Varicose Veins 185
https://t.me/med1917
operations were performed are given. Sixty-four point six
percent of patients in the sclerotherapy group had between
one and fi ve visits, with never more than four injections
being given at a time; 23.8% had between six and 10 visits,
and 11.6% had over 10 visits. Outcome was measured at one
and two years simply by ascertaining whether patients had
required further treatment (i.e., injections) or not. Subjective
or objective evaluation of the limbs is not described.
At the end of one year, 24.2% of limbs in the sclerotherapy group had required further treatment, compared to 44.8%
in the surgical group. After an additional year’s follow-up,
another 21.3% in the injection group and 16.4% in the surgical group had received further treatment although, as the
authors admit, the high drop-out rate by this stage (about one
third) made these results of uncertain signifi cance.
The authors conclude that “the initial response of varicose veins is better if Fegan’s method is used than if they
are operated upon.”
This is the only randomized trial to come down in favor
of sclerotherapy over surgical treatment. Unfortunately there
appear to be too many fl aws in the study to warrant its rather
grand title. The follow-up period is too short; other studies
agree that after one year, results of the two forms of treatment may be similar, but that the recurrence rate rises in the
injection group therafter. The requirement of almost half the
surgically treated group to have injection sclerotherapy
within a year of operation is troubling. As mentioned, we
do not know what operations were done, but this fi gure suggests that the surgeons involved may have been less than
assiduous in their performance of multiple avulsions. The
method of deciding whether treatment has failed or not
seems intrinsically unfair; patients receiving sclerotherapy
can go on doing so at weekly intervals for an indefi nite
period until the clinician is satisfi ed, whereas surgical
patients needing, perhaps, just one or two post-operative
injections are classed as treatment failures.
The paper confi rms that skilled sclerotherapy is an effective treatment for varicose veins in the short to medium
term, but cannot be said to have shown it to be a superior
treatment to surgery.
Jakobsen’s 1979 paper
10
counts as one of the key papers
on the subject by being one of the very few studies to
compare directly surgical and sclerotherapeutic treatment.
However it suffers in its subjective method of classifi cation
and assessment. Through no fault of its author, it was written
a few years before Doppler examination and duplex ultrasound became standard objective methods of assessment of
venous abnormality.
Some 516 patients who presented with saphenous varices
were stratifi ed to one of three treatment groups. It is unclear
whether this was a randomization or not. The three groups
comprised 161 patients who had radical surgery—junctional
ligation with excision of the Great and/or Small Saphenous
vein, 165 patients who had junctional ligation under local
anesthetic combined with sclerotherapy, and 157 patients
who had sclerotherapy alone (Sigg’s method). No information is given concerning the number of treatment sessions
or number of injections per session in the sclerotherapy
group.
Patients were followed up at three months and at three
years. Their outcome was classifi ed both objectively and
subjectively. Results for all treatments were, broadly speaking, very good at three months but differences were demonstrated at the three-year follow-up. By objective evaluation,
89.8% of patients undergoing radical surgery had satisfactory results, as had 65.2% in the local surgery + sclerotherapy group. Only 36.6% of those having sclerotherapy
alone were classifi ed as objectively satisfactory at three
years. Interestingly, the patients’ subjective evaluations of
their outcome showed less striking differences, with 93%,
84.8%, and 70.5%, respectively, reporting that they were
satisfi ed with the results at three years. The authors conclude
that radical surgery is the best treatment for varicose
veins.
The most recently published of the very few randomized
trials comparing surgery with sclerotherapy is by Einarsson
11
One hundred and sixty-four patients with symptom-
et al.
atic primary varicosities were randomized to either operative treatment or compression sclerotherapy (CST). Patients
were assessed clinically and by foot volumetry before treatment. Eighty patients underwent surgery and 84 had CST.
They were well matched for age, sex, and pattern of venous
disease. The type of surgery was determined by the clinical
diagnosis (e.g., Great or Small Saphenous incompetence)
and the presence or absence of perforating vein incompetence. Sclerotherapy was performed by Hobbs’ modifi cation
of Fegan’s technique. An average of fi ve injections per
patient was given, over either one, two, or three sessions.
Patients in both groups had four to six weeks of posttreatment compression.
Patients were followed up at six months, one year, three
years, and fi ve years. They were assessed by clinical inspection, subjective opinion of the patient, and by foot volumetry. Follow-up compliance was reasonably good, with 78%
(CST) and 76% (surgery) attending for the full fi ve-year
follow-up.
At one year, 97% of surgical patients and 82% of CST
patients considered themselves cured or improved. The
physician’s assessment was 93% and 80%, respectively. The
results in the CST group fell away over the following four
years. By fi ve years, 95% of surgical patients still considered
themselves cured or better, compared with only 45% in the
CST group. Objective assessment gave fi gures of 90% and
26%, respectively. The foot volumetry results, measuring
expelled volume (a measure of calf muscle function) and
refi lling fl ow (a measure of refl ux), gave broadly similar
results. Ten percent of operated patients had problems with
sural or saphenous nerve damage, whereas 22% of CST
186 Chapter 19/Conventional Sclerotherapy versus Surgery for Varicose Veins
https://t.me/med1917
patients had problems with superfi cial thrombophlebitis.
Most of this was minor, but fi ve patients required surgery
because of phlebitis in the long saphenous vein and were
thus classifi ed as failures.
This seems to have been a well-conducted trial, the results
of which support those of Hobbs and Jakobsen. The trial
started just before duplex scanning became generally available, but foot volumetry is a valid method for assessing calf
muscle function and refi lling times and has been shown to
correlate well with direct venous pressure measurements.
However the average number of injections5 given to patients
in the sclerotherapy arm of the trial seems remarkably small,
leading to the inevitable question as to whether more assiduous treatment in this group might not have led to a better
outcome. In addition, the high rate of postinjection superfi cial thrombophlebitis suggests that the empty-vein technique
required by Fegan may not always have been achieved.
Two further trials warrant mention, although neither can
be considered as seminal as those described earlier. A multiauthor (31 authors), multicenter trial covering 10 years has
been reported12 in which patients were randomized to receive
one of six treatment regimens: sclerotherapy, high-dose
sclerotherapy, multiple ligations, stab avulsions, foam
sclerotherapy, and ligations + sclerotherapy. A variety of
clinical and laboratory-based endpoints were used. After 10
years, no clear differences in outcome could be identifi ed
and all treatment modalities were considered to be of broadly
equal effi cacy. It is diffi cult to draw clear conclusions from
this paper, and the absence of a group treated by standard
surgery—long saphenous stripping with fl ush SFJ ligation
and multiple avulsions—would seem to be an opportunity
missed.
A Dutch paper from the same year13 compared simple
phlebectomy to sclerotherapy in 98 limbs. A clear advantage
for phlebectomy at two years was demonstrated.
Another paper of interest compared stripping the Great
Saphenous vein to a combination of high saphenofemoral
ligation and sclerotherapy of the varicosities.14 One hundred
and eighty-six limbs with proven isolated saphenofemoral
incompetence were randomized to one treatment or the
other. After three years, there was a clear advantage for the
group who had undergone stripping, both subjectively and
objectively, although a very high (33%) frequency of saphenous nerve damage was reported in this group. However this
study is not really comparable to those described earlier
since neither patient group underwent sclerotherapy alone.
Also of interest is the paper of Brethauer et al.,
15
in which
service personnel or members of their families underwent
saphenofemoral ligation and perforator ligation combined
with either stab phlebectomies or sclerotherapy. The two
groups were not randomized and the follow-up period is
quite short (mean follow-up time = 418 days), so the results
must be treated with caution. However, it is of interest to
fi nd that there was no difference in outcome or patient
satisfaction between the two groups, but that the surgical
group had their treatment completed in a shorter period of
time.
Three further publications from the last decade must
be mentioned—a consensus document, a questionnaire of
current practice, and a Cochrane review.
16
The fi rst
summarizes the proceedings of three consensus conferences held in Padua (twice) and Venice in 1994
and 1995. Thirty-one participants (all but one European) and
eight further participants (six from outside Europe) met to
answer the question: Is sclerotherapy effective and, if so,
under what circumstances? Participants and contributors
were acknowledged experts, invited by nomination from
national phlebological societies. It was felt that personal
experience was of greater importance in this area than many
others in medicine, since the low scientifi c standard of many
phlebological publications made an evidence-based approach
diffi cult. A questionnaire was sent to over a thousand phlebogists worldwide in order to reveal current practice in the
fi eld of sclerotherapy.
It was agreed that sclerotherapy is the treatment of choice
for small varicose veins. Unfortunately the term “small” is
not defi ned but includes telangiectasia and reticular veins.
For larger veins not arising from an incompetent saphenous trunk, it was agreed that sclerotherapy was an adequate
treatment, though there appears to have been some dissent
about its role in treating incompetent perforating veins.
No consensus could be reached on whether or not varicosities arising from an incompetent Great Saphenous vein
should be treated by sclerotherapy. It was agreed that veins
arising from an incompetent Small Saphenous system could
be treated by either surgery or sclerotherapy, but it was felt
that there was inadequate evidence in the literature to give
any recommendations on this point.
Agreement was reached that the following circumstances
constituted absolute contraindications to the use of sclerotherapy: allergy to the sclerosing agent, severe systemic
disease, recent DVT, infection, inability to walk, and severe
arterial disease. Most of these would, of course, also constitute contraindications to surgery.
The participants highlighted the shortcomings in the
small number of randomized controlled studies that have
been reported. The discrepancies between the excellent
results of personal series and those of randomized trials is
also pointed up. The participants agreed that it was impossible to say whether or not sclerotherapy prevented complications of varicose veins. In future studies, the following
outcome measures were suggested: prevention and treatment of complications, patient satisfaction, reattendance,
lack of effect, side effects, recurrence of varicose veins, and
cost. An ideal study was proposed, which would have the
following characteristics:
Chapter 19/Conventional Sclerotherapy versus Surgery for Varicose Veins 187
https://t.me/med1917
1) Prospective, randomized, controlled.
2) Homogenous patient sample; for example, all long
saphenous vein varicosities. Preprocedure investigation
would be mandatory to ensure this.
3) Standardized sclerotherapy technique.
4) All complications and side effects of treatment to be
recorded.
5) Independent assessment of objective criteria when
measuring outcome.
6) At least fi ve years follow-up, with full details of all
subsequent treatment.
This paper is a thorough and honest attempt to reach clear
recommendations about the practice of sclerotherapy in
venous disease. Unfortunately, perhaps inevitably, the consensus recommendations are so unexceptional as to be
anodyne. This may be due to the large number of participants but more importantly refl ects the poor quality of the
literature available, which the authors recognize. It is disappointing that instead of making suggestions about how to
fi nd out which technique of sclerotherapy works best, the
authors make the rather bland suggestion that it is left to
individual clinicians to use the method they like best. The
most useful part of the document is the outline of the ideal
study in examining the effi cacy of sclerotherapy, which
should act as a model for future investigators.
A subsequent paper17 described the results of a study in
which 350 members of the Vascular Surgical Society of
Great Britain and Ireland were contacted by post and asked
about the place of venous sclerotherapy in their practice.
They were also asked whether their use of the technique was
increasing or decreasing with time.
Two hundred eighteen (62%) replied: 18.3% never
used sclerotherapy; only 4.6% used it when the patient was
known to have proximal junctional incompetence; 69.7%
used it when such incompetence was absent; 77% used the
method to treat residual varices left behind after operation;
64.7% used it to treat recurrent varices without junctional
incompetence.
The median compression time was less than that usually
recommended by the inventors of the technique. The median
time after sclerotherapy for varicose veins was two weeks,
whereas after sclerotherapy for telangiectasia it was only
four days.
The trend was for surgeons to use sclerotherapy less
frequently for varicose veins than formerly, but more often
for telangiectasia.
One important point coming out of this study was that
only 33% of respondents both used sclerotherapy and had a
specialized varicose vein clinic. Clearly, this limits the scope
for training junior surgeons. Lack of proper training may
lead to poor technique, and this may contribute to what some
would see as an ongoing underuse of the method.
Perhaps the most important publication of recent times
on this topic has been the 2004 Cochrane Systematic
Review,18 which set out to examine the evidence concerning
the question suggested by the title of this chapter. The
authors searched 13 databases, contacted health economics
agencies and guideline producing agencies, examined trial
registers, and in general did everything possible to ensure
all relevant data were included in the review. Only nine
randomized trials were identifi ed and the variety of outcome
measures and classifi cation systems meant that the authors
felt unable to draw fi rm conclusions or make recommendations. They commented that there was a trend for early
results to favor sclerotherapy but, after a follow-up period
of two to three years, for this trend to be reversed in
favor of surgery. Insuffi cient data on costs prevented a costeffectiveness recommendation being made either.
These papers give a snapshot of current feeling about the
use of sclerotherapy. The majority of trials that compare
surgery with sclerotherapy for primary varicose veins indicate that the results are similar over the medium term, but
that in the long term, surgery is more durable, with fewer
recurrences. Whether this matters all that much can be
debated. In a level-headed editorial on the topic,19 Guex and
Isaacs argue that recurrence is not a disaster “as if venous
refl ux were akin to cancer” and that the need for reinjection
may still represent an acceptable outcome. Clearly, the prospect of a “once and for all” treatment, with two weeks off
work and a small risk of surgical complications will be
appropriate to some patients, but for others a less invasive
procedure, avoiding anesthesia, but with an increased likelihood of eventual reintervention will be preferable. There
is no right answer.
Most vascular surgeons agree that sclerotherapy is the
treatment of choice for thread veins, and use the technique
for these and for residual or recurrent veins after defi nitive
surgery.
One problem that occurs in comparing surgery to sclerotherapy is that the latter, especially, is dependent on the
degree of skill and commitment with which it is applied.
Whereas stripping the long saphenous vein is basically an
all-or-nothing procedure, the outcome of which is likely to
be much the same whether it be done smoothly or clumsily
(within limits!), the same cannot be said of injection treatment. Inexpertly performed sclerotherapy is likely to lead to
very poor results and many complications. Thus committed
advocates of the technique, who spend a great deal of time
and concentration in using the method, are likely to get
better results than those who view it as an inferior treatment
and use it reluctantly. The argument that papers that report
poor outcomes following sclerotherapy do so because the
injections were done improperly, or insuffi ciently, or with
inadequate compression, is always going to be diffi cult to
counter, and may well, of course, have some truth in it.
188 Chapter 19/Conventional Sclerotherapy versus Surgery for Varicose Veins
https://t.me/med1917
References
1. Browse NL, Burnand KG. Diseases of the veins. 1988. London;
Arnold.
2. Sigg K. The treatment of varicosities and accompanying complications, Angiol. 1952. 3: 355–379.
3. Shami SK, Cheatle TR, eds. Fegan’s compression sclerotherapy for
varicose veins. 2003. London: Springer-Verlag.
4. Keller WL. A new method of extirpating the internal saphenous and
similar veins in varicose conditions: A preliminary report, NY Med J.
1905. 82: 385–386.
5. Hobbs JT. Surgery and sclerotherapy in the treatment of varicose veins,
Arch. Surg. 1974. 109: 793–796.
6. Chant ADB, Jones HO, Weddell JM. Varicose veins: A comparison of
surgery and injection/compression sclerotherapy, Lancet. 1972. 2:
1188–1191.
7. Beresford SAA, Chant ADB, Jones HO et al. Varicose veins: A comparison of surgery and injection/compression sclerotherapy—Five year
follow-up, Lancet. 1978. 1: 921–924.
8. Seddon J. The management of varicose veins, Br. J. Surg. 1973. 60:
345–347.
9. Doran FSA, White M. A clinical trial designed to discover if the
primary treatment of varicose veins should be by Fegan’s method or
by operation, Br. J. Surg. 1975. 62: 72–76.
10. Jakobsen BH. The value of different forms of treatment for varicose
veins, Br. J. Surg. 1979. 66: 182–184.
11. Einarsson E, Eklof B, Neglen P. Sclerotherapy or surgery for
varicose veins: A prospective randomized study, Phlebology. 1993. 8:
22–26.
12. Belcaro G, Cesarone MR, Di Renzo A et al. Foam-sclerotherapy,
surgery, sclerotherapy and combined treatment for varicose veins: A
10-year, prospective, randomised, controlled trial (VEDICO Trial),
Angiol. 2003. 54: 307–315.
13. De Roos PK, Niemann FHM, Neumann HAM. Ambulatory phlebectomy versus compression sclerotherapy; results of a randomised controlled trial, Dermatol. Surg. 2003. 29: 221–226.
14. Rutgers PH, Kitslaar PJEHM. Randomized trial of stripping versus
high ligation combined with sclerotherapy in the treatment of the
incompetent greater saphenous vein, Am. J. Surg. 1994. 168: 311–
335.
veins: Proximal saphenofemoral ligation comparing adjunctive varicose phlebectomy with sclerotherapy at a military medical center,
Vasc. Surg. 2001. 35: 51–58.
16. Baccaglini U, Spreafi co G, Castoro C, Sorrentino P. Consensus conference on sclerotherapy of varicose veins of the lower limb, Phlebology.
1997. 12: 2–16.
17. Galland RB, Magee TR, Lewis MH. A survey of current attitudes of
British and Irish vascular surgeons to venous sclerotherapy, Eur. J.
Vasc. Endov. Surg. 1998. 16: 43–46.
18. Rigby KA, Palfreyman SJ, Beverley C, Michaels JA. Surgery versus
sclerotherapy for the treatment of varicose veins, The Cochrane Database of Systematic Reviews. 2004. Issue 4. Art. No.: CD004980. DOI:
10.1002/14651858.CD004980.
19. Guex JJ, Isaacs MN. Comparison of surgery and ultrasound guided
sclerotherapy for treatment of saphenous varicose veins: Must the
criteria for assessment be the same? Int. Angiol. 2000. 19: 299–302.
CHAPTER
https://t.me/med1917
20
Sclerotherapy and
Ultrasound-Guided Sclerotherapy
PAUL THIBAULT
SCLEROTHERAPY
Varicose veins are a degenerative disease of the venous
system where there is a defect in the strength of the vein
wall with associated valvular dysfunction resulting in refl ux
(reverse) fl ow in affected areas of the superfi cial venous
system of the legs. Usually refl ux from the deep to superfi cial system through incompetent venous junctions and perforator veins is a major contributor to the superfi cial venous
insuffi ciency. Because venous disease is a chronic disease,
treatment usually is directed at controlling the disease rather
than curing it. It is therefore important that interventional
treatment does not aggravate the condition in the long
term.
Sclerotherapy refers to the method of treating varicose
veins, where a foreign substance, usually a chemical, is
introduced into the lumen of a vein to cause endothelial
necrosis and subsequent fi brosis of the vein. Apart from
reducing the size of the vein to a small fi brous cord, effective
sclerotherapy also eliminates the physiopathological refl ux
associated with varicose veins. As such, sclerotherapy is an
alternative treatment to surgery and other physical endovenous ablation techniques such as endovenous laser (EVL)
in the management of varicose veins. Sclerotherapy differs
from the other ablative techniques in that it can be effective treatment for all types of pathological venous dilatations from major truncal varicose veins to the fi nest
telangiectases.
Sclerotherapy for varicose veins associated with Great
Saphenous vein (GSV) and Small Saphenous vein (SSV)
incompetence traditionally has been relegated to treating
residual varicose veins following surgical stripping or varicose veins associated with isolated perforator vein incompetence.
1
Apart from a relatively brief period of popularity
of the Fegan method of sclerotherapy in the 1960s and early
1970s, surgical methods generally have been accepted as
having a signifi cantly better long-term recurrence rate compared to sclerotherapy. This has been thought to be due to
the fact that traditional sclerotherapy was unable to control
the proximal source of refl ux—usually the saphenofemoral
(SFJ) and saphenopopliteal (SPJ) junctions—adequately. In
addition, preultrasound methods of sclerosing the GSV have
been shown to be relatively ineffective. Some methods such
as the Cloutier technique administered a single “blind”
injection of a major sclerosing agent a few centimeters
below the SFJ, repeated every seven to 21 days until the
GSV was occluded. Such methods have been openly discouraged as creditable methods of treating GSV or SSV
incompetence because they were thought to have an inheritantly high risk of damaging the deep venous system or of
inadvertent intraarterial injection.
Duplex ultrasound has become the gold standard in the
investigation of lower limb venous disease. As an independent investigation, duplex scanning has unrivalled relevance
in the clinical decision-making process as well as being used
in the serial assessment of disease progress and effectiveness
of treatment. Ultrasound guidance of sclerosant injections is
a logical extension of the pretreatment evaluation and gives
sclerotherapy the potential to rival other ablative methods in
effectiveness in the treatment of varicose veins.
HISTORY OF ULTRASOUND-
GUIDED SCLEROTHERAPY (UGS)
The method of ultrasonic guidance of injection into the
superfi cial venous system was fi rst published in 1989.2 The
method initially was used for treatment of incompetent
The Vein Book
189
All rights of reproduction in any form reserved.
Copyright © 2006, Elsevier Inc.
190 Chapter 20/Sclerotherapy and Ultrasound-Guided Sclerotherapy
https://t.me/med1917
saphenous axes and in 1992 the method of injecting
in competent perforating veins associated with postsurgical
recurrences was described.3 Medium-term results of SFJ
incompetence treated by UGS were reported by Kanter and
Thibault in 1996.4 In the late 1990s, several practitioners
around the world began using sclerosant foam injected using
ultrasound guidance, and the fi rst medium-term results were
reported by Cabrera in 2000.5 Since that time UGS using
microfoamed sclerosants has become the accepted method
of UGS.
6
PRETREATMENT
ULTRASOUND MAPPING
Duplex venous scanning is the essential pretreatment
investigation prior to either sclerotherapy or UGS of major
varicose veins and truncal incompetence. Through duplex
scanning, patterns of venous incompetence will be found to
be extremely variable and often unexpected. Duplex scanning involves B-mode imaging of the deep and superfi cial
veins combined with directional pulsed Doppler assessment
of blood fl ow. Color-duplex imaging superimposes blood
fl ow information onto the B-mode ultrasound image, permitting visual assessment of blood fl ow while creating an anatomical map of the venous anatomy. The details of venous
duplex examination have been described in a previous
chapter and will not be dealt with here.
In short, duplex examination is able to provide an accurate anatomical and physiological map of superfi cial and
deep venous incompetence and localize points of refl ux from
the deep to superfi cial venous system. With duplex examination a detailed map of refl ux paths in the superfi cial system,
from the proximal origin of the refl ux (usually from the deep
system) to a distal reentry point, can be created. This map
will allow optimal decisions regarding sclerotherapy intervention and will ensure that all signifi cant areas of refl ux are
addressed by treatment and, conversely, that all normal
veins are preserved.7 Diameters of major veins and junctions
are also recorded during the duplex examination. These
measurements may infl uence various parameters of the
treatment process including selection of sclerosing agent
and foam, and postsclerotherapy compression.
Following the duplex examination, the treatment process
then is directed toward eliminating all the incompetent
superfi cial pathways mapped out with duplex ultrasound,
and then in the posttreatment phase, reexamining with
duplex to ensure that the refl ux pathways have not recanalized prior to complete fi brosis of the vein that usually occurs
between six to 12 months following initial treatment.
TECHNIQUES OF ULTRASOUND-
GUIDED SCLEROTHERAPY (UGS)
Sclerosing Agents
Generally, only relatively strong sclerosants are used
in UGS. In an international survey8 of 44 phlebologists
who were known to use UGS extensively, 95% used sodium
tetradecyl sulphate (STS) (FibroveinTM; STD Pharmaceuticals, Hereford, England), and 5% used 3% polidocanol
(POL) (AethoxysclerolTM; Kreusler Pharma, Wiesbaden,
Germany). There was a small minority of phlebologists that
used polyiodinated iodine as an alternative solution in particular circumstances, such as in the presence of allergy to
STS or at deep to superfi cial junctions. With sclerosant
concentration, generally 3% STS was used although some
phlebologists use STS in various strengths from 0.75% to
2%.
In this survey, 34% of phlebologists used foamed sclerosants with STS again being the most common agent used
as foam. It is likely that the ratio of phlebologists using foam
sclerosants compared with solution foam has increased signifi cantly since that survey, as the benefi ts of foam have
become more widely known. The use of foam is described
in more detail in another chapter.
9
In a recently published study,
STS and POL, in both
solution and foam formulations were shown to have similar
effi cacy, tolerability, and patient satisfaction. There is good
evidence, however, that POL is a weaker detergent type of
sclerosant than STS10 and higher concentrations are necessary to produce complete vascular sclerosis for any given
diameter of vein (see Table 20.1).
11
This is the most likely reason why the majority of phlebologists prefer STS when performing UGS, as in general,
larger truncal veins are being treated with this technique.
6
Patient Positioning
For treatment of veins on the medial aspect of the leg,
patients are placed in the supine position with the treated leg
level and externally rotated at the hip. The knee is usually
TABLE 20.1 Approximate Equivalent Concentrations of STS
and Polidocanol Required for Effective Sclerosis of Increasing
Caliber of Lower Limb Veins
Vein caliber STS concentration Polidocanol concentration
mm % %
0.1–0.5 0.1 0.25
0.5–1.0 0.15 0.5
1.0–2.0 0.3 1.0
2.0–3.0 0.5 1.5
3.0–5.0 0.75 2.0
5.0–8.0 1.0–3.0 3.0–5.0
Techniques of Ultrasound-Guided Sclerotherapy (UGS) 191
https://t.me/med1917
slightly fl exed in order to relax all muscle groups. If small
incompetent veins are being treated, the patient can be
placed in the semireclining position in order to dilate the
veins slightly, thereby assisting ultrasound visualization and
subsequent injection. For treatment of veins on the posterior
thigh or calf, the patient is positioned in the prone position
with the foot supported by a pillow so that the knee is fl exed
slightly.3 This positioning is important when injecting the
SSV near the popliteal fossa, where the vein will be compressed if the knee is totally extended.
Closed Needle Technique
Materials
The needle size used can vary from 21 g to 25 g. The most
common size used is 25 gauge 11/2 inch (0.50 × 38 mm),
because this is the smallest diameter needle that is readily
visualized by B-mode ultrasound, and is long enough to
reach most superfi cial veins from the point of skin penetration. Usually the sclerosant is drawn up into a 2 or 3 ml luer
lock syringe. When microfoam is used, the Tessari method11
will also require the use of a 5 ml Luer lock syringe to draw
up air or other gas to form the microfoam.
Method
The closed needle technique is the most commonly used
method.8 With this technique, the needle is attached to the
syringe containing the sclerosant at all times. A smaller
proportion of phlebologists use an open needle technique
(needle is removed to determine color/fl ow of blood).
The procedure may be performed with the assistance of a
vascular sonographer, or with the phlebologist performing both the ultrasound and the injections alone (solo
technique).
The initial injection usually is performed near to the
proximal origin of the venous refl ux.4 A small proportion of
practitioners inject more distally, then manually “milk” the
sclerosant toward the proximal source of refl ux using realtime ultrasound monitoring. Either way the fi nal objective
is to have the total segment of incompetent vein, from the
proximal refl ux point to the distal reentry point, uniformly
fi lled with sclerosant foam. This can be observed with realtime B-mode ultrasound and will be accompanied by vasospasm of the treated vein.
The sonographer initially will localize the site of the vein
to be injected in transverse view. The depth of the vein
below the skin surface will be noted, as this will determine
the angle of approach of the needle. The injection can then
be performed either with the vein viewed in transverse
section or in sagittal or longitudinal section. Approximately
50% of practitioners utilize the transverse approach solely,
33% the longitudinal approach solely, and the remainder use
8
both approaches depending on various technical variables
associated with each individual injection.8 The transverse
approach is favored by some, especially when performing
the procedure solo because it appears to be technically easier
to cannulate the vein with this method. It is therefore particularly useful when injecting smaller veins less than 3 mm
in diameter. The advantages of the longitudinal approach
are, fi rst, that the direction of fl ow of the sclerosant can be
observed and, second, the linear array probes can be used to
compress the segment of vein for a length of about 50 mm
during the injection, thereby allowing better contact of the
sclerosant with the vein wall at the injection site.
The imaging frequency of the transducer used may vary
from 7.5 MHz to 15 MHz; the lower frequencies are used for
deeper placed subcutaneous veins (>3 cm below the skin)
and higher frequencies for more superfi cial veins. Commonly a 10 MHz transducer is used for its ability to imagine
most subcutaneous veins adequately. Most transducers will
have an indicator line or LED that will indicate the alignment of the sagittal plane of the transducer. For either
approach, the needle is inserted close to the transducer tip
and along the sagittal plane of the transducer (see Figure
20.1).3 When the needle pierces the skin, the tip should be
visualized by the ultrasound. Adequate amounts of ultrasound gel need to be applied to the skin to obtain optimum
visualization.
As the needle is slowly inserted it appears as a refl ective
straight line angling toward the target vein (see Figure 20.2).
It is important to verify early in the procedure that the needle
is being introduced in the correct sagittal plane of the transducer. When injecting in the transverse section of the vein,
the transducer can be moved in small increments to align
with the needle. When injecting in the longitudinal section
of the vein, the direction of needle may need to be altered
in small increments, to align with the sagittal plane of the
transducer. For either method, the needle and vein should
be imaged simultaneously at all times.
As the needle tip makes contact with the target vein, an
indentation will be seen on the vein wall (see Figure 20.3).
At this stage a little extra pressure is required to pierce the
vein wall and after this occurs, the needle can be seen within
the lumen and a small amount of blood is drawn into the
needle hub to confi rm correct intraluminal positioning of the
needle tip. A small volume (approx. 0.2 ml) of sclerosant is
then injected and should be seen on the ultrasound image to
be fl owing into the vein (see Figure 20.4). Extravasation is
readily visible on the B-mode image and is manifested as a
separation between the vein wall and the peri-venous tissues.
Should this occur, injection is stopped immediately, and
the needle tip is repositioned correctly, or alternatively, the
needle withdrawn and reinserted at an appropriate nearby
site. When the initial small volume is seen to fl ow intraluminally, the remainder of the injection is then completed
under continuous ultrasound imaging.
Соседние файлы в папке Библиотека им академика М.И. Перельмана