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Chapter
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10
Table 10.4 RCTs of HL+S versus EVLA
Type of Procedure Article Conclusion
HL+ S
versus
EVLA
Role of Surgery in the Treatment of Varicose Veins
EVLA versus cryostripping Disselhoff BCVM, der Kinderen DJ, Moll FL. Is
EVLA, endovenous laser ablation; F-U, follow-up; HL, high ligation; QoL, quality of life; S, saphenous stripping.
Darwood RJ, et al. Randomized clinical trial
comparing endovenous laser ablation with
surgery for the treatment of primary great
saphenous veins. Br J Surg 2008;95:294
De Medeiros et al. Comparison of endovenous
treatment with an 810-nm laser versus
conventional stripping of the great saphenous
vein in patients with primary varicose veins.
Dermatol Surg 2005;31:1685
Kalteis M, Berger I, Messie-Werndl S, et al. High
ligation combined with stripping and
endovenous laser ablation of the great
saphenous vein: early results of a randomized
controlled study. J Vasc Surg 2008;47:822
Rassmussen et al. Randomized trial comparing
endovenous laser ablation of the great
saphenous vein with ligation and stripping in
patients with varicose veins: short-term results.
J Vasc Surg 2007;46:308
there a risk for lymphatic complications after
endovenous laser treatment versus
cryostripping of the great saphenous vein? A
prospective study. Phlebology 2008;23:10-4
Disselhoff BCVM, der Kinderen DJ, Kelder JC,
Moll FL. Randomized clinical trial comparing
endovenous laser with cryostripping for great
saphenous varicose veins. Br J Surg
2008;95:1232-8
Disselhoff BCVM, Buskens E, Kelder JC, der
Kinderen DJ, Moll FL. Randomized comparison
of Costs and Cost-effectiveness of cryostripping
and Endovenous Laser ablation for Varicose
veins: 2-year results. Eur J Vasc Endovasc Surg
2009;37:357-63
810-nm laser diode stepwise withdrawal
(n = 42) and continuous withdrawal (n = 29) versus conventional
surgery (n = 32)
F-U 3 months
Abolition of reflux and improvement in disease specific QoL comparable
Earlier return to normal activity with EVLA P = 0.005
810-nm laser diode sequential withdrawal
(n = 20) versus conventional surgery (n = 20)
F-U 9 months (mean)
Post operative pain comparable
Fewer swellings and less bruising after EVLA. P ?
More benefits with EVLA. P?
810-nm laser diode sequential withdrawal + HL (n = 47) versus
conventional surgery (n = 48)
F-U 4 month
Hematomas smaller with EVLA. P = 0.001
EVLA was associated with a longer period of time until return to
work P = 0.054
No difference in terms of health related QoL (CIVIQ)
980-nm laser diode pulse mode (n = 62) versus conventional surgery
(n = 59)
F-U 6 months
Short-term efficacy and safety are similar.
Except for slightly increased postoperative pain and bruising in HL+S
group no differences were found
810-nm laser diode withdrawal mode not mentioned
17 EVLA (n = 17) vs cryostripping (n = 16)
F-U 6 months
One complication lymphedema after cryostripping
810-nm laser diode withdrawal mode not mentioned
= 46) versus cryostripping (n = 46)
EVLA (n
F-U 2 years
With EVLA less postoperative pain P = 0.003
Return to normal activity shorter P = 0.002
Clinical and hemodynamic outcome no difference
810-nm laser diode withdrawal mode not mentioned
60 EVLA (n = 60) versus cryostripping (n = 60)
F-U 2 years
Outpatient cryostripping less costly and more effective P = ns
Varices phlebectomy with conservation of
the refluxing saphenous trunk
A retrospective study was undertaken of 303 lower extremities
(221 patients), all presenting with saphenous trunk (ST) reflux
of more than 0.5 seconds (GSV, 85.8%; SSV, 11.9%; and GSV
and SSV, 2.3%), that had been treated according to the ASVAL
method. The ST reflux was shown to be reduced to less than
0.5 seconds in 69.6%, 69.2%, 68.7%, 68.0%, and 66.3% of
limbs, respectively, after 6 months, 1, 2, 3, and 4 years of
follow-up. Symptoms improved or disappeared in 84.2%,
84.2%, 83.4%, 81.4%, and 78.0% of limbs at each annual
check-up until year 4. Freedom of varices recurrence was
95.5%, 94.6%, 91.5%, and 88.5%, respectively, at 1, 2, 3, and
4 years.
294
When, preoperatively, reflux in the saphenous trunk
extended from its termination to the malleolus, the elimination of the ST reflux was less frequent (47.6% vs 70.3%;
P < .05).
31
CHIVA method
A great number of observational studies, mostly retrospective
by Italian and Catalonian teams, have been reported. Their
analyses are sometimes difficult for other practitioners
to understand, owing to the use of the specific CHIVA
terminology and the modification of the technique itself, but
CHIVA protagonists are happy with this method if the preoperative hemodynamic shunt type (CHIVA language) has been
correctly identified. Two long-term RCTs are available that
supports its use (see Table 10.6).
71
Table 10.5 RCTs of HL+S versus surgery preserving the GSV
https://t.me/med1917
Type of Procedure Article Conclusion
HL+S+ Perforator ligation
versus
HL + tributary phlebectomy
+/– perforator ligation
HL+S
versus
CHIVA
F-U, follow-up; HL, high ligation; S, saphenous stripping
Campanello M, et al. Standard stripping versus
long saphenous vein saving surgery for
primary varicose veins: a prospective,
randomized study with the patients as their
own controls. Phlebology 1996;11:45
Dwerryhouses et al. Stripping the long
saphenous vein reduces the rate of
reoperation for recurrent varicose veins. J Vasc
Surg 1999;29:589
Winterborn RJ, et al. Causes of varicose vein
recurrence: late results of a randomized
controlled trial of stripping the long
saphenous vein. J Vasc Surg 2004;40:34
Carandinas et al. Stripping versus
haemodynamic correction (CHIVA): a long
term randomised trial. Eur J Vasc Endovasc
Surg 2008;35:230-7
Parés JO, Juan J, Tellez R, Mata A, Moreno C,
Quer FX et al. Varicose vein surgery. Stripping
versus the CHIVA method : a randomized
controlled trial. Ann Surg 2010;251:624-31
HL + tributary phlebectomy+ perforator ligation (n = 18 group 1)
versus HL+ stripping + tributary phlebectomy + perforator ligation (n
= 18 group 2)
Post operative course
Less subjective post operative discomfort
F-U 4 years
No difference in terms of clinical outcome and plethysmography
GSV compressible and patent when preserved
HL + tributary phlebectomy (n = 58) versus HL+ stripping + tributary
phlebectomy (n = 52)
At F-U 5 and 11 years
No difference in terms of recurrence but in the group with
preservation of the saphenous trunk redo surgery was performed
more frequently P = 0.012
HL+S (n = 75) versus CHIVA (n = 75)
10 years F-U
With CHIVA
Less recurrence P = 0.04
501 patients C2-C6 randomized in 3 groups
- HL+ Stripping with clinic marking (S-CM group n =167)
- HL+ stripping with duplex marking (S-DM group n = 167)
versus CHIVA group n = 167)
5 years F-U
CHIVA > HL+ stripping in terms of recurrence P
< 0.001
Indications for Surgery
Table 10.6 RCTs of HL+S versus foam sclerotherapy
Type of Procedure Article Conclusion
CA + HL
versus
HL+S
CA
versus
HL+S
CA, chemical ablation; F-U, follow-up; HL, high ligation; S, saphenous stripping.
Indications for Surgery
Bountouroglou DG, Azzam M, Kakkos SK, et al.
Ultrasound-guided foam sclerotherapy combined
with sapheno-femoral ligation compared to surgical
treatment of varicose veins: early results of a
randomised controlled trial. Eur J Vasc Endovasc
Surg 2006;31:93
Abela R, Liamis A, Prionidis I, et al. Reverse foam
sclerotherapy of the great saphenous vein with
sapheno-femoral ligation compared to standard
and invagination stripping: a prospective clinical
series. Eur J Vasc Endovasc Surg 2008;36:485
Figueiredo M, Araujo S, Barros N Jr, Miranda F Jr.
Results of surgical treatment compared with
ultrasoundguided foam sclerotherapy in patients
with varicose veins: a prospective randomised
study. Eur J Vasc Endovasc Surg 2009;38:758
Liquid sclerotherapy + HL (n = 30) versus HL+S (n = 30)
F-U 3 months
Early recanalization in 13% after CA treated by complementary injection
CA+HL less expansive, more rapid return to normal activities P < 0.0001
No difference in term of complication and occlusion
HL+ reverse foam sclerotherapy (n = 30), HL + cryostripping (n = 30),
HL+S (n = 30)
HL+ reverse foam sclerotherapy less post operative complication and
better patient satisfaction
Foam sclerotherapy (n =
(n = 29) in C5 patients
F-U 6 months
Vein obliteration AC 78%, HL+S 90%. P = ns related to the small number
of patients included
thermal ablation. In Europe, surgery with preservation of the
saphenous trunk (including ASVAL and CHIVA) has some
supporters.
In absence of long-term follow-up RCTs evaluating the different treatment methods including surgery, only weak
recommendations according to Guyatt
77
can be stated. Nevertheless, it appears that surgery is presently giving way to
minimally invasive procedures; that is to say chemical and
Indications according to etiology
Only primary varices will be considered – post-thrombotic or
congenital varices are a specific problem that will not be devel-
27) 1–3 sessions 10 mL/session vs HL+S
295
Chapter
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10
Table 10.7 RCTs of hook phlebectomy versus powered phlebectomy
Type of Procedure Article Conclusion
Hook phlebectomy versus
Trivex
Trivex (InaVein LLC, Lexington, Mass.)
Role of Surgery in the Treatment of Varicose Veins
Aremu M, Mahendran B, Butcher W, et al.
Prospective randomized controlled trial:
conventional versus powered phlebectomy. J
Vasc Surg 2004;39:88
Scavée V, Lesceu O, Theys S, et al. Hook
phlebectomy versus transilluminated powered
phlebectomy for varicose veins surgery. Early
results. Eur J Vasc Surg 2003;25:473
Ray-Chaudury SB, Huq Z, Souter RG, McWhinnie
D. A randomized controlled trial comparing
transilluminated powered phlebectomy with
hook avulsions: an adjunct to day surgery. One
Day Surg 2003;13:24
oped in this chapter. The systematic use of DUS, including
routine investigation of the deep vein combined with other
examinations, prevents the wrong indication of VV treatment
in post-thrombotic syndrome.
Indications according to the clinical
presentation
Clinical presentation may sometimes influence the
indication.
Pregnancy
In women, pregnancy may influence the indication. It has
been established that the REVAS risk after GSV conventional
surgery in a woman who has already had a child is higher in
subsequent pregnancies.
upon then a less invasive procedure is recommended, such as
combining it with chemical or thermal ablation in order to
avoid open surgery at the groin.
Association of VV with another disease
Obesity
Given the understanding that postoperative complications are
higher in obese people following SFJ surgery, open surgery at
the groin is not recommended.
Peripheral Arterial Occlusive Disease and Coronary Disease
The treatment of varicose veins in the presence of peripheral
arterial occlusive disease (PAOD) or coronary disease (CD)
tends toward being conservative, particularly because of the
potential need for a vein graft. In this situation, if VVs need
to be treated then surgery preserving the saphenous trunk is
recommended providing the saphenous vein is suitable for
use as a replacement conduit. Nevertheless, a vein that cannot
be used as a graft should be treated and the practitioner must
not forget that the association of severe VVs and PAOD
increases the risk of ulcer.
Lymphedema
If operative treatment is needed, chemical and thermal ablation are less dangerous than surgical techniques, the aim being
not to damage the lymphatics.
Indications according to the CEAP class
In the C2 class (non-complicated VVs) there is no argument
that favors surgery to other operative treatments. In compli-
296
79
If an operative treatment is decided
No difference in terms of patient satisfaction and cosmetic result
No difference in postoperative pain
cated VVs, particularly in C6 patients, only RCTs comparing
classical surgery to conservative treatment are available,
apart from one small series involving treatment with CHIVA.
50-52
79
That does not demonstrate that classical surgery provides a
better outcome in patients presenting with venous ulcer, as
observational studies with thermal and clinical ablation
include C
patients.
6
81
Indications according to anatomic and
physiopathologic anomaly
Reflux at the SFJ and/or at the SPJ
In theory, with major reflux at the SFJ or SPJ (particularly when
the terminal valve is incompetent and the terminal portion of
the saphenous trunk very enlarged), classical surgery is the
best option as HL+S are supposed to solve the problems. This
recommendation was stated by Cappelli but no data support
12
it.
However, patients with an incompetent terminal valve
treated with preservation of the SFJ had a good outcome in
the Pittaluga’s series.
treated using thermal ablation by RF with preservation of the
SFJ was as good as after classical surgery at 5 years.
14
Furthermore, outcome in patients
53,54,82
In
any case, SFJ has been examined at a median follow-up of 25
months by DUS and the most common finding in the groin
was an open, competent SFJ with a greater than 5-cm patent
terminal GSV segment conducting prograde tributary flow
through the SFJ (82%) (Fig. 10.16).
Knowing that neovascularization at the groin is frequent
and the major cause of recurrence at the SFJ after HL
83
13,54,83,84
(Fig. 10.17), whatever the pathophysiology, is inconclusive;
there is no RCT comparing saphenous trunk stripping with
and without HL.
Competent saphenous trunk
When the saphenous trunk is competent there is no RCT that
allows one to prefer surgery with preservation of the saphenous trunk to surgical, thermal or chemical ablation, but the
former seems to be at least logical.
Combination of primary deep reflux and
primary varices
When primary deep reflux (PDR) is sequential there is a large
consensus to consider that it does not modify the indication
for VV treatment. Conversely, when PDR is axial and in the
presence of severe chronic venous insufficiency (C
particularly with recurrent ulceration, valvuloplasty must be
considered in the patient reluctant to wear stockings or noncompliant to compression.
85
, C6), and
4b
Figure 10.16 DUS. Physiological drainage of the superficial epigastric vein
https://t.me/med1917
in the stump of the SFJ after radiofrequency ablation. (From Perrin M. Traitement
chirurgical endovasculaire des varices des membres inf
(Elsevier Masson SAS, Paris), Techniques chirurgicales
érieurs. Techniques et résultats. EMC
– Chirurgie vasculaire, 43-161-C, 2007).
Combination of primary deep obstruction and
primary varices
According to Raju and Neglen primary iliac obstruction is
frequently associated with varices in patients with severe
venous symptoms or chronic venous insufficiency. When
patients are not improved by complete VV treatment, investigation of the iliac vein is recommended to identify obstruction
and possible stenting.
86,87
Incompetent perforator and varices
Although perforator incompetence can be treated by surgery
this topic will be broached only briefly in this chapter. In presence of skin changes and when surgery has been chosen,
subfascial endoscopic surgery has to be preferred to open
surgery. Even though perforators can be treated either by
chemical or thermal ablation or by surgery, there is no RCT
comparing the outcome of these different techniques. Never-
References
Figure 10.17 Duplex ultrasound. Neovascularization at the previous area of
the saphenofemoral junction after high ligation. CFV, Common femoral vein
(Courtesy of Dr Gillet).
theless, there is a consensus that recommends treating VVs first
when incompetent perforators are associated with primary
venous reflux.
Conclusions
Long-term follow-up should be able to reveal information on
the precise indications for surgery in the era of endovenous
ablation and should help determine what the appropriate
procedure is for treating VV according to clinical and hemodynamic features. New procedures are introduced frequently,
and when results on their usage are reported the techniques
are quickly either modified, abandoned or supplanted.
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MS, et al. Radiofrequency ablation
(VNUS Closure) does not cause
neo-vascularisation at the groin at one
year: results of a case controlled study.
Surgeon 2006;4:71.
60. Lurie F, Creton D, Eklof B, et al.
Prospective randomized study of
endovenous radiofrequency
obliteration (closure procedure) versus
ligation and stripping in a selected
patient population (EVOLVES Study).
J Vasc Surg 2003;38:207.
61. Lurie F, Creton D, Eklof B, et al.
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Prospective randomized study of
endovenous radiofrequency
obliteration (closure) versus ligation
and vein stripping (EVOLVeS): two-year
follow-up. Eur J Vasc Endovasc Surg
2005;29:67.
62. Rautio T, et al. Endovenous obliteration
versus conventional stripping operating
in the treatment of primary varicose
veins: a randomized controlled trial
with comparison of the costs. J Vasc
Surg 2002;35:958.
63. Perälä J, Rautio T, Biancari F, et al.
Radiofrequency endovenous
obliteration versus stripping of the long
saphenous vein in the management of
primary varicose veins: 3-year outcome
of a randomized study. Ann Vasc Surg
2005;19:1.
64. Subramonia S, Lees T. Radiofrequency
ablation vs conventional surgery for
varicose veins – a comparison of
treatment costs in a randomized trials.
Eur J Vasc Endovasc Surg 2009;39:104.
65. Darwood RJ, Theivacumar N,
Dellagrammaticas D, et al. Randomized
clinical trial comparing endovenous
laser ablation with surgery for the
treatment of primary great saphenous
veins. Br J Sug 2008;95:294–301.
66. de Medeiros CAF, et al. Comparison of
endovenous treatment with an 810 nm
laser versus conventional stripping of
the great saphenous vein in patients
with primary varicose veins. Dermatol
Surg 2005;31:1685.
67. Kalteis M, Berger I, Messie-Werndl S,
et al. High ligation combined with
stripping and endovenous laser
ablation of the great saphenous vein:
early results of a randomized
controlled study. J Vasc Surg
2008;47:822.
68. Rassmussen LH, Bjoern L, Lawaetz M,
et al. Randomized trial comparing
endovenous laser ablation of the great
saphenous vein with ligation and
stripping in patients with varicose
veins: short-term results. J Vasc Surg
2007;46:308.
69. Winterborn RJ, Foy C, Earnshaw JJ.
Causes of varicose vein recurrence: late
results of a randomized controlled trial
of stripping the long saphenous vein.
J Vasc Surg 2004;40:34.
70. Carandina S, Mari C, De Palma M,
et al. Stripping vs haemodynamic
correction (CHIVA): a long term
randomised trial. Eur J Vasc Endovasc
Surg 2008;35:624.
71. Parés JO, Juan J, Tellez R, et al. Varicose
vein surgery. Stripping versus the
CHIVA method: a randomized
controlled trial. Ann Surg
2010;251:624–31.
72. Bountouroglou DG, Azzam M, Kakkos
SK, et al. Ultrasound-guided foam
sclerotherapy combined with saphenofemoral ligation compared to surgical
treatment of varicose veins: early results
of a randomised controlled trial. Eur J
Vasc Endovasc Surg 2006;31:93.
73. Abela R, Liamis A, Prionidis I, et al.
Reverse foam sclerotherapy of the great
saphenous vein with sapheno-femoral
ligation compared to standard and
invagination stripping: a prospective
clinical series. Eur J Vasc Endovasc Surg
2008;36:485.
74. Figueiredo M, Araujo S, Barros N Jr,
Miranda F Jr. Results of surgical
treatment compared with
ultrasoundguided foam sclerotherapy
in patients with varicose veins: a
prospective randomised study. Eur J
Vasc Endovasc Surg 2009;38:758.
75. Aremu M, Mahendran B, Butcher W,
et al. Prospective randomized controlled
trial: conventional versus powered
phlebectomy. J Vasc Surg 2004;39:88.
76. Scavée V, Lesceu O, Theys S, et al. Hook
phlebectomy versus transilluminated
powered phlebectomy for varicose
veins surgery. Early results. Eur J Vasc
Surg 2003;25:473.
77. Ray-Chaudury SB, Huq Z, Souter RG,
McWhinnie D. A randomized
controlled trial comparing
transilluminated powered phlebectomy
with hook avulsions: an adjunct to day
surgery. One Day Surg 2003;13:24.
78. Guyatt G, Gutterman D, Baumann MH,
et al. Grading strength of
recommendations and quality of
evidence in clinical guidelines: report
from an American College of Chest
Physicians Task Force. Chest
2006;129:174.
79. Fischer R, Chandler JG, Stenger D, et al.
Patients characteristics and physiciandetermined variables affecting
saphenofemoral reflux recurrence after
ligation and stripping of the great
saphenous vein. J Vasc Surg 2006;43:81.
80. Zamboni P, Cisno C, Marchetti P, et al.
Hemodynamic CHIVA correction versus
compression for primary venous ulcers:
first year results. Phlebology 2004;19:28.
81. Vasquez MA, Wang J, Mahathanaruk M,
et al. The utility of venous clinical
severity score in 682 limbs treated by
radiofrequency saphenous ablation.
J Vasc Surg 2007;45:1008.
82. Merchant RF, Pichot O for the Closure
Study Group. Long-term outcomes of
endovenous radiofrequency
obliteration of saphenous reflux as a
treatment for superficial venous
insufficiency. J Vasc Surg 2005;42:502.
83. Pichot O, Kabnick LS, Creton D, et al.
Duplex ultrasound scan findings two
years after great sapenous vein
radiofrequency endovenous
obliteration. J Vasc Surg 2004;39:189.
84. van Rij AM, Jones GT, Hill GB, Jiang P.
Neovascularization and recurrent
varicose veins: more histologic and
ultrasound evidence. J Vasc Surg
2004;40:296.
85. Perrin M. Deep venous reconstructive
surgeryto treat reflux in the lower
extremities. Phlebolymphology
2005;49:375.
86. Neglen P, Hollis KC, Raju S. Combined
saphenous ablation and iliac stent
placement for complexe severe chronic
disease. J Vasc Surg 2006;44:828.
87. Raju S, Neglen P. High prevalence of
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chronic venous disease: a permissive
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2006;44:136.
References
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Chapter 10: Appendix
10
Role of Surgery in the Treatment of Varicose Veins
300
Information for the patient
Surgery for varicose veins in the legs
Dear Madam, Dear Sir,
You have chronic superfi cial venous insuffi ciency (more commonly called varicose veins), which is caused by poor superfi cial vein function in the legs.
Varicose veins
Blood fl ows from the heart to the extremities through arteries and returns to the
heart through superfi cial and deep veins. The deep veins provide most of this
venous return and are the most important. The walls of superfi cial veins may
become damaged and lose their elasticity. The sick veins become dilated and
tortuous. Venous return to the heart is then slowed down, particularly in immobile or seated positions. The blood stagnates in the feet, ankles and legs, leading
to edema, unsightly venous dilatations (varicose veins) that may be more or less
visible, dilatation of the small vessels (telangectasias), etc.
The exact cause of primary superfi cial venous insuffi ciency is not known. In
women, it is promoted by pregnancy. Other aggravating factors have been identifi ed: heredity, obesity, sedentary, lifestyle static professional activities, plantar
arch disorders (fl at feet, arched feet, etc.).
More rarely, superfi cial venous insuffi ciency is caused by an abnormality in the
deep veins including post-thrombotic syndrome or congenital malformations.
Symptoms and risks of progression
Varicose veins may be associated with symptoms: heaviness and pain in the legs,
itching, restlessness, night cramps, feeling of burning and or swelling, etc.
In the absence of appropriate treatment for varicose veins, complications
develop insidiously in many patients: pigmentation, eczema, hardening of the
skin on the legs (lipodermatosclerosis) or even ulcers. Varicose veins may also
cause acute complications:
– hemorrhage (either spontaneous or caused by direct injury);
– superfi cial venous thrombophlebitis (infl ammation and thrombosis of the
superfi cial veins) that may sometimes cause deep vein thrombosis (= clot in a
deep vein), the major immediate risk of which is pulmonary embolism (= clot
that moves to the lung) with a risk of death depending on the severity
Therapeutic possibilities
Surgery is one of the fundamental treatments for extensive varicose veins. The
aim is to remove the “sick” superfi cial veins or to modify the abnormal fl ux that
perturbs proper functioning of the venous circulation. An ultrasound examination (Doppler ultrasound) is used to determine whether a surgical procedure is
necessary and to choose the most appropriate technique for your case.
Other non-surgical treatments exist:
– use of elastic compression which relieves and prevents complications but
not cure;
– drugs for relieving symptom
– sclerotherapy which involves injecting a sclerosing product into the varix to
destroy it.
This last treatment is often necessary in addition to other operative treatment
including surgery
Operative procedures
Until the last years, the procedure usually performed was sapheno-femoral/popliteal ligation—in association with saphenous trunk stripping and incompetent
tributary phlebectomy
In each limb, there are two veins that are usually responsible for superfi cial
venous insuffi ciency:
– the great saphenous vein (which runs from the medial surface of the ankle to
the fold of the groin. There, it connects with a deep vein the femoral vein. To
remove I—the great saphenous vein, an incision must be made in the fold of
the groin and another incision (smaller) must be made on the medial surface
of the ankle and/or at the garter;
– the small saphenous vein which extends from the lateral surface of the ankle
to the calf and hollow of the knee where it connects with a deep vein the the
popliteal vein.
To remove it, an incision must be made in the hollow of the knee and in the calf.
The tributaries of these principal superfi cial veins may also be responsible for
varicose veins, which are removed by phlebectomy (micro-incisions in the skin,
through which they are removed with a hook).
Other operative techniques less invasive have been developed in the last
decades.
These include:
– isolated phlebectomy
– various procedures which principle will be explained by your doctor
– the thermal techniques that ablate the vein by radiofrequency or laser
beams using a probe (or catheter) that is inserted into the lower section of
the sick vein and that is pushed up to the groin or hollow of the knee.
– sclerotherapy which involves injecting a sclerosing product into the varicose
veins to obliterate them
Prevention and treatment
Regardless of the surgical technique used, it is performed in an environment that
meets prevailing aseptic and safety norms for all surgical procedures. It requires
local and sometimes general anesthesia that must be defi ned depending on the
vein treated, the surgical treatment, the expected duration of the procedure, your
s
age, health and medical history. The anesthesia procedures will be described
during the preoperative consultation in the institution where the procedure will
be performed. Remember to take with you a list of all medication you take regularly and report possible allergies. The procedure will require short hospitalization
ranging from a few hours or
severity of the surgery, your age, health and medical history.
Postoperative period
After the procedure, diffuse ecchymosed (“bruises”, without consequence)
rapidly disappear, as do hematomas (effusion of blood) near the incisions or along
the stripping pathway.
The postoperative period is generally without complications and activities can
be progressively resumed a few days after the procedure. The duration of sick
leave depends on the severity of the operation, on the technique used and the
postoperative period. Your physician will specify how long your must wear bandages or compression stockings.
Possible complications
A certain number of complications related to the surgery may occur. You may
discuss this with your physician prior to the procedure.
Benign complications
The benign complications are as follows:
– painful hardening (nodules sensitive to the touch) under the incisions or along
the pathway of stripping:
– delayed healing of incisions or injections (rare, more common in obese
people).
– unsightly or hypertrophic scars (cheloids);
– persistent pigmentation or redness of the skin, appearance of telangectasias
(small blue or red dilated venules).
Minor complications
The minor complications are as follows:
– postoperative hemorrhage (very rare) requiring exceptionally repeat surgery.
If bleeding occurs near an incision, fi rmly press the location for at least 5
minutes. If it continues, call your doctor;
– rare superfi cial venous thrombophlebitis in a triutary not severe, but that
requires medical treatment;
– rare effusion of lymph from the scars (lymphorrhea) that disappears;
– transient postoperative edema (swelling) of the ankle and/or foot, that disap-
pears without sequela and is often the result of poorly applied elastic bandages
or stockings (wear the prescribed compression properly);
– persistent edema requiring prolonged elastic compression;
– onset or aggravation of lymphedema in predisposed people;
– localized sensory disorders (abnormal feeling on the skin) that may present as
does
dysesthesia (localized reduction or disappearance of sensitivity to the touch,
feeling of tingling, pins and needles, that usually disappears within a few
weeks) or, in rare cases, hyperasthesia (feeling of burning, electric shock, pain
sometimes requiring medication until it subsides).
More severe complications
Rare cases of deep vein thrombosis that may be:
– localised (in the veins in the calf), often without sequela following treatment;
– extensive at the root of the thigh or higher, with a risk of later post-thrombotic
syndrome.
In rare cases, this may
a clot to the lungs), which is serious and may cause immediate death or later
respiratory problems. Deep vein thrombosis mainly occurs in obese people or
those with reduced mobility, elderly people, patients with coagulation disorders
or personal or family history of deep vein thrombosis, in patients with severe
concomitant diseases. In these cases, postoperative prevention may be necessary
(injections of heparin). Your physician will do everything in his/her power to avoid
this very rare complication, which may also occur if one neglects to treat varicose
veins.
Complications during repeat surgery
During operations for recurrent varicose veins, skin complications and healing
disorders are most common. Lymphorrhea (effusion of a yellowish fl uid, lymph)
may appear in the fold of the groin when the great saphenous vein is operated
again. The risks of sensory disorders are more common in association with redo
procedures in the popliteal fossa ( area behind the knee).
Long-term monitoring
Varicose veins are a progressing disease. Therefore, it is crucial that you receive
long-term postoperative follow-up (for several years, even for the rest of your life)
to prevent recurrences by treating them early.
The aim of this information is not to worry you but to inform you and make
you aware that there is no such thing as minor surgery. Not treating varicose
veins is not without risk either.
Furthermore, rest assured that the surgery proposed to you is the result of a
well-thought-out and substantiated decision based the best benefi t/risk ratio for
you.
Declaration
Following an appointment with Dr _____________, I acknowledge having
received clear and detailed information on the planned surgery. I have been
informed of the particular risks and possible complications of this procedure.
ambulatory basis to a few days depending on the
be complicated by pulmonary embolism (= migration of
C H A P T E R
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Intravascular Approaches to the Treatment of
Varicose Veins: Radiofrequency and Lasers
11
Medical care in the 21st century has evolved into a minimally
invasive realm. Procedures once performed under general
anesthesia in which patients’ bodies were surgically opened to
allow removal of organ systems are being replaced by techniques that allow the treatment of damaged organ systems to
occur with the patient awake. This evolution has permeated
the field of phlebology starting with vein valve repair and
progressing to thermocoagulation of a vein from within the
vein using endoluminal radiofrequency (RF) or various laser
wavelengths. Further development of minimally invasive techniques should continue well into the next decade.
The first attempt at minimizing the extent of surgery for
varicose vein disease was the application of ligation alone. It
was thought that the mere ligation of the saphenofemoral
junction (SFJ) without disturbance of the great saphenous
vein (GSV) with invasive techniques such as stripping the
entire GSV to the ankle would be effective. Unfortunately, this
minimal surgical treatment was demonstrated to result in a
high degree of recurrence (upward of 50% at 3 to 5 years) even
when the ligation was accompanied by sclerotherapy or
ambulatory phlebectomy of distal varicose veins.
these recurrences where evaluated, treatment failure was secondary to reanastomosis through hemodynamically significant perforator or anastomotic veins extending from the knee
to the groin, which remained in place after ligation alone.
Since ligation alone failed to provide acceptable degrees of
improvement in abnormal venous hemodynamics, it was recommended that more invasive complete removal of the GSV
from the SFJ to the knee after ligating the SFJ be performed.
However, stripping typically required general anesthesia, with
patients usually taking a week or more to get back to normal
activities. So it appeared that, due to lack of effectiveness, the
first attempts at reducing the extent of surgery by ligation
alone failed to gain acceptance. Ironically, the continued
necessity for stripping probably spurred the development of
endovenous techniques as many patients would shudder at
the thought of stripping. The race was on to develop a minimally invasive alternative using intravascular laser and RF
devices to thermocoagulate endothelial cells and vein walls,
producing specific destruction of the targeted vessel without
the necessity of stripping or ligation.
1–5
When
Radiofrequency Closure
The first theories of endovenous ablation were based on the
belief that specifically directing relatively omnidirectional RF
energy into vein walls to cause their destruction was potentially safer, easier to engineer and more controllable than
other mechanisms for doing so. Initial designs involved a
mechanism by which RF current heated tissue by resistive (or
ohmic) heating of a narrow rim (less than 1 mm) of tissue in
direct contact with an electrode. Deeper tissue planes could
be slowly heated by conduction from the small-volume region
of heating, although heat was typically dissipated by conduction into surrounding normothermic tissue.
lating the degree of heating with microprocessor control,
subtle gradations of either controlled collagen contraction or
total thermocoagulation of the vein wall could be achieved.
The initial design was such that when the RF catheter was
pulled back, a feedback-controlled loop regulated by readings
from a thermocouple enabled the operator to heat a section
of vein wall to a specified preset temperature. This was chosen
for its relative safety since the temperature increase remained
localized around the active electrode. This necessitated the
maintenance of close, stable contact between the active electrode and the vessel wall without coagulum formation. It was
believed by strictly limiting the temperature to 85°C, boiling,
vaporization, and carbonization of the tissues could be
avoided.
to 85°C resulted in heating the vein media to no more than
65°C, the minimal temperature at which collagen contracts.
logical changes following radiofrequency ablation at various
powers and application times. When low power (5 W) and an
application time up to 400 ohms was applied, histological
changes were not uniform. Necrosis was limited to the
6
endothelium in the majority of vein segments and rarely
reached the media. This would most likely not result in complete vein shrinkage and occlusion. At 20 W and an application time up to an impedance of 400 ohms, histological
changes included widespread necrosis of the initima and
media and collagen bundle coagulation. The authors concluded that with increased power and application time,
there was a more homogenous and extensive heating of the
vein wall, which was thought to lead to a more successful
outcome.
limiting process. As coagulation of tissue occurs, there is a
marked decrease in impedance that limits heat generation.
Alternatively, if a clot builds up on the electrodes, blood is
heated instead of tissue and there is a marked rise in impedance (resistance to RF). The RF generator can be programmed
to rapidly shut down when impedance rises, thus assuring
minimal heating of blood but efficient heating of the vein
wall. The problem is that the electrodes must be manually
debrided of coagulum, which requires the removal of the
catheter, cleaning by the operator and then reinsertion –
which is problematic during tumescent anesthesia.
ablation was the Closure System (VNUS Medical Technologies, Sunnyvale, Calif., now Covidien, North Haven, Conn.).
With the Closure catheter system, bipolar electrodes are
deployed by spring action and placed in contact with the
vein wall. As the vein wall contracts, the electrodes are able
to retract somewhat within the vein allowing vein wall
8
It was also believed that heating the endothelial wall
Ex-vivo studies by Reich-Schupke et al
Vessel wall ablation using electrode-mediated RF is a self-
The initial system introduced with electrode-mediated RF
7
By carefully regu-
9
investigated histo-
10
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11
Intravascular Approaches to the Treatment of Varicose Veins: Radiofrequency and Lasers
302
narrowing. Selective insulation of the electrodes results in a
preferential delivery of the RF energy to the vein wall and
minimal heating of the blood within the vessel.
The initial catheter designs included collapsible catheter
electrodes and a central lumen to allow a guidewire and/or
fluid delivery structured within the 5-French (1.7-mm) catheter. This permits treatment of veins as small as 2 mm and as
large as 8 mm. A larger 8-French catheter allowed treatment
of saphenous veins up to 12 mm in diameter. Both catheters
had thermocouples on the electrodes embedded in the vein
wall which measured temperature and provided feedback to
the RF generator for temperature stabilization. The control
unit displayed power, impedance, temperature, and elapsed
time so that precise control could be obtained. The unit delivered the minimum power necessary to maintain the desired
electrode temperature. For safety, if a coagulum formed on
the electrodes, the impedance rises would cut off the RF
generator.
The initial experience, dating back to 1998, demonstrated
an efficacy equal to or better than that of ligation and stripping, with few, if any, adverse sequelae.
11–23
Early experience
directly comparing RF Closure with ligation and stripping
procedures, even with RF performed under general anesthesia,
noted equal efficacy with less pain, shorter ‘sick leave’, and
faster return to normal activities.
18
When performed by us, the procedure was entirely under
local tumescent anesthesia, with over 90% of patients resuming normal activities 1 to 2 days postoperatively. Its main
drawbacks were the high cost of single-use catheters and the
necessity to withdraw the catheter manually at a speed of 2
to 3 cm per minute and frequent cleaning of coagulum on
the electrodes, which made the procedure tedious at times.
To speed up the procedure, Goldman
12
recommended that
only the most proximal 20 cm of the GSV be treated with
RF and the remaining varicose GSV be treated with ambulatory phlebectomy, but this technique has not found wide
acceptance. Goldman believes that the addition of ambulatory phlebectomy minimizes the possibility of recurrence
from distal perforators. Proebstle et al
24
found that up to
30% of tributary veins do not resolve with laser ablation of
the GSV alone, thereby necessitating removal with ambulatory
phlebectomy.
However, treatment of the GSV or its tributaries below the
knee may not be entirely necessary, as others have shown that
ligation and stripping procedures from the groin to the knee
add little to the procedure’s efficacy.
15,25
In addition, others
have also demonstrated equal effectiveness with less than 2
years follow-up when only the proximal 30 to 40 cm of the
GSV is treated without treating distal varicose tributaries.
13–15,17,26
Weiss and Weiss17 evaluated patients treated with a percu-
taneous approach allowing access of the Closure catheter to
treat the proximal GSV. Patients (mean age, 47.2 ± 12.6 years;
76% female) had symptomatic saphenous reflux with a saphenous vein diameter of 2 to 12 mm (mean, 7.4 mm). Most of
the veins treated were above-knee great saphenous (73%),
some entire great saphenous (21%), with the remaining
including below-knee great saphenous, small saphenous, and
accessory saphenous. Adjunctive procedures performed at the
time of treatment were phlebectomy on more distal branches
in 61% and high ligation in 21%, but the adjunctive procedures did not affect outcome.
Vein occlusion at 1 week was documented by duplex ultrasound in 300 out of 308 legs, or a success rate of 97%. Occlusion persisted at 6 weeks in 95% and at 6 months in 92%. In
this report, if the saphenous vein was closed at 6 months it
was noted by duplex ultrasound to remain closed to 12
months and beyond. Subsequent follow-up for up to a decade
by duplex ultrasound indicates that any vein noted to have
been eliminated at 12 months by RF will never recur. Typically
when the GSV is treated there is closure or elimination of
major tributaries at the SFJ except for the superficial or superior epigastric vein, which, intentionally not treated, continues
to empty superiorly into the common femoral vein. We
believe that there is a high margin of safety by maintaining
flow through this tributary. The high flow rate appears to
diminish the possibility of extension of any thrombus (in the
unlikely event that this would occur) from the GSV and has
the additional benefit of allowing normal venous flow from
the lower abdominal wall into its proper drainage into the
common femoral vein. By leaving the superior epigastric vein
intact, thrombus in the GSV following this procedure has not
been observed.
Long-term efficacy with the RF ablation has been docu-
mented by Merchant et al
13
27
investigating 1222 limbs (great
saphenous, small saphenous, and accessory saphenous veins).
Occlusion rates (evaluated via duplex ultrasound) of 96.8%,
89.2%, 87.1%, 88.2%, 83.5%, 84.9%, and 87.2% were found
at 1 week, 6 months, 1 year, 2 years, 3 years, 4 years, and 5
years, respectively. Body mass index greater than 25 was associated with an increased incidence of nonocclusion, groin
reflux, and recanalization. A pullback speed above 3 cm/
minute at 85°C was more likely to result in nonocclusion and
recanalization. In the study by Vasquez et al,
28
factors associated with improved occlusion rates included increasing
age, female sex, and volumes greater than 250 ml of tumescent anesthesia. The authors theorized that increased failure
rates associated with male sex and younger age are secondary to variations in collagen and inflammation in these
populations.
Regarding clinical symptoms, a successful RF (or laser)
endovenous occlusion procedure rapidly reduces patient pain,
fatigue, and aching, correlating with a reduction in the CEAP
clinical class for symptoms and clinical severity of disease.
When patients have had simultaneous surgical stripping on
the opposite leg, the degree of pain, tenderness, and bruising
have been far greater on the leg treated by stripping. Side
effects of the Closure technique have included thrombus
extension from the proximal GSV in 0.8%, with one case of
pulmonary embolus; also, skin burn (prior to the tumescent
anesthesia technique) in 2.5%, clinical phlebitis at 6 weeks in
5.7%, and temporary quarter-sized areas of paresthesia in
18%, with most of these occurring immediately above the
knee and resolving within 6 months to a year. Thus, compared
with most techniques – but, in particular, traditional surgery
of ligation and stripping of similar size saphenous veins – the
effectiveness of endovenous RF occlusion is quite high.
In a study by Goldman and Amiry,
16
closure of the GSV
with endoluminal RF thermal heating in combination with
ambulatory phlebectomy was equally as effective as closure
of the GSV as described above. The first 47 sequential, nonrandomized patients having an incompetent GSV from an
incompetent SFJ and painful varicosities in 50 legs were
treated with the VNUS Closure procedure. The varicose veins
were marked with the patient standing and again with the
patient lying down in the operative position with a venoscope
(LLC, Lafayette, La.), as previously described (Fig. 11.1).
12,29,30
After appropriate marking, the area surrounding the GSV and
distal tributaries to be treated was infiltrated with 0.1% lidocaine tumescent anesthesia. The amount of tumescent fluid
averaged 800 mL with a lidocaine dose of 8 mg/kg. The
GSV was then accessed through a 2- to 3-mm incision in
the medial midthigh, usually 20 cm inferior to the SFJ. The
proximal portion of the GSV was then treated with VNUS
Closure and the distal portion, including all varicose tributaries, was removed with a standard ambulatory phlebectomy
technique.
Thirty-nine patients with 41 treated legs were available for
evaluation at the longest follow-up period. Six patients (nine
treated legs) could not be located for re-evaluation after 6
months because of change in location (often out of the state).
Figure 11.1 Premarkings. Varicose veins were marked with the patient
https://t.me/med1917
standing and again with the patient lying down in the operative position
with a Venoscope (LLC, lafayette, La.).
The average time to access the GSV in the medial thigh was
7 minutes (range, 1–30 minutes). Twenty-seven patients had
the GSV accessed in approximately 1 minute. The average
catheter pullback rate was 2.76 cm/minute over an average
length of treated GSV of 19 cm (range, 6–42 cm). Complete
surgical time, including the phlebectomy portion of the procedure, was approximately 20 minutes (range, 13–35 minutes).
Ninety-five percent of all patients could resume all preoperative activities within 24 hours. The other two patients could
resume all activities within 48 hours. Every patient had complete elimination of leg pain and fatigue. Twenty-one of 22
patients who presented with ankle edema had resolution of
ankle edema. All patients said that they would recommend
this procedure to a friend.
Adverse sequelae were minimal, with four patients complaining of heat distal to the SFJ during the procedure which
resolved with additional tumescent anesthesia. Twenty-eight
of 50 treated legs had some degree of purpura lasting 1 to 2
weeks. Five patient legs developed mild erythema over the
GSV closure site that lasted 2 to 3 days. Eight legs had an
indurated fibrous cord over sites of ambulatory phlebectomy
that lasted up to 6 months.
Clinical and duplex evaluation performed by an independent laboratory and/or physician at 6, 9, 12, 18, and 24 months
disclosed 90% abolition of reflux. No new varicose veins were
noted to appear in three patients with recurrent reflux in the
GSV. One patient who developed reflux had the development
of new veins at 1 year post-treatment.
Other surgeons have had a different experience with the use
of VNUS Closure in the treatment of incompetent GSV. The
reason for the difference in results is likely to be secondary to
the anesthesia used, as well as the technique, as described below.
Three separate papers detail a similar cohort of patients
treated in multicenter studies encompassing from 16 to 31
clinics, 210 to 324 patients, and 6 to 12 month follow-up.
13,14,31
The vein occlusion rate at 1 year examination was 91.6% from
nine centers and 81.9% from fourteen centers. Forty-nine
patients were followed at 2 years with duplex scans and
showed an 89.8% closure rate. There was a 3% incidence of
paresthesia which was decreased to 1.6% when treatment was
confined to the thigh. Two limbs (0.8%) developed scarring
from skin burns and three patients developed a deep vein
thrombosis (DVT) with one embolism. The reason for the
increase in adverse effects appears to be the use of general
anesthesia without tumescent anesthesia by a majority of the
surgeons.
Sybrandy and Wittens
32
from Rotterdam reported one year
follow-up of 26 patients treated with VNUS Closure. They
reported five patients with postoperative paresthesia of the
saphenous nerve and one with a cutaneous burn, for an
overall complication rate of 23%. One patient (3.8%) had
total recurrence of the GSV. One patient (3.8%) could not be
treated due to a technical failure. Eight patients (30.8%) had
closure of the GSV, but with persistent reflux of the SFJ. Thirteen patients (50%) had closure of both the GSV and SFJ.
Overall, 88% of patients had a totally occluded GSV.
One probable reason for the increase in adverse effects was
their use of a spinal anesthesia instead of the recommended
tumescent anesthesia. In addition, they treated all patients
from the ankle proximally, which exposed the GSV within the
calf to heat from the RF catheter. Their mean operating time
was 67 minutes (range, 25–120 minutes).
Another report describes two episodes of DVT in 29 patients
treated with the RF Closure.
33
Here, the surgeons treated the
patient with a groin incision and passage of the catheter from
the groin downward. The authors do not report the type of
anesthesia used or the length of vein treated. It is presumed
that patients were not ambulatory and were treated under
general anesthesia.
The important information to come out of a review of
various treatments of the GSV is that the use of tumescent
anesthesia in awake patients who can ambulate immediately
after the procedure is important in preventing skin burns and
DVT. Treatment when limited to the GSV segment above the
knee is also important in preventing paresthesia to the saphenous nerve.
In our experience using tumescent anesthesia in awake
patients, two patients have developed focal numbness 4 cm
in diameter on the lower medial leg. These resolved within 6
months. Since adopting the principles outlined above of
tumescent anesthesia and moving the catheter rapidly from
any points of sharp pain, no paresthesias have been noted. No
skin injury or thrombus has been observed in any of our
patients. Unfortunately, with both endoluminal RF and laser
procedures, if patients are not ambulatory after the procedure
and/or if tumescent anesthesia is not given, complications in
the form of DVT, PE, or angiogenesis have been reported.
Tumescent anesthesia or the placement of large volumes of
dilute anesthesia in a perivascular position serves several
purposes:
• to protect perivascular tissues from the thermal effects of
intravascular energy such as RF
• to decrease the diameter of the treated vein to allow for
better contact of the RF electrodes or laser fiber tip with
the vein wall, and thus secondarily reduce intravascular
blood for nonspecific coagulation
• to provide local anesthesia for patients so that they may
be awake during the procedure with the ability to report
any pain or discomfort and walk off the operating table
and around the recovery room.
34
Contrary to the report by Hingorani et al
we have never
seen DVT in any of our patients treated with intravascular laser
or RF. We believe that the reason for our lack of adverse sequelae is the use of tumescent anesthesia in awake patients with
immediate ambulation and avoidance of occlusion of the
superior epigastric vein. While we realize treating patients
without general anesthesia is not standard practice for general
or vascular surgeons,
37
some vascular surgeons who perform
tumescent anesthesia on awake patients with immediate
34–36
Radiofrequency Closure
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