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282 Chapter 30/Effects of Different Laser Wavelengths on Treatment of Varices
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another, although subtle short-term differences in postprocedural bruising, pain, itching, and phlebitis have been
noted; however, none of these differences is lasting or
appears to impact vein occlusion rates. More double-blinded,
randomized, prospective trials may be necessary to provide
further insight into the importance of the many variables in
EVLA therapy; however, at this time it appears that the
lasers used for ablation of the saphenous veins are effective
with minimal morbidity and complications.
References
1. Forrestal MD, Min RJ, Zimmet SE, Isaacs MN, Moeller MR. Endovenous laser treatment (EVLTTM) for varicose veins—A review. In:
Todays Ther Trends. Princeton Junction, NJ: Communications Media
for Education. 2002. 20(4): 299–310.
2. Goldman M, Mauricio M, Rao J. Intravascular 1320-nm laser closure
of the great saphenous vein: A 6- to 12-month follow-up study, Dermatol Surg. 30: 1380–1385.
3. Morrison N. Saphenous ablation: What are the choices, laser or RF
energy? Semin Vasc Surg. 2005. 18: 155–118.
4. Perrin M. Endovenous treatment of lower-limb varices by laser and
radiofrequency, Phlebolymphology. 2005. 48: 337–346.
5. Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of
saphenous refl ux—A multicenter study, J Vasc Surg. 2002. 35: 1190–
1196.
6. Navarro L, Min RJ, Boné C. Endovenous laser: A new minimally invasive method of treatment for varicose veins—Preliminary
observations using an 810 diode laser, Dermatol Surg. 2001. 7: 326–
327.
7. Min RJ, Zimmet SE, Isaacs MN, Forrestal MD. Endovenous treatment
of the incompetent great saphenous vein, J Vasc Interv Radiol. 2001.
12: 1167.
8. Proebstle TM, Lehr HA, Kargl A et al. Endovenous treatment of the
great saphenous vein with a 940-nm diode laser: Thrombotic occlusion
after endoluminal thermal damage by laser-generated steam bubbles, J
Vasc Surg. 2002. 35: 729–736.
9. Oh CK, Jung D, Jang H, Kwon K. Endovenous laser surgery of the
incompetent great saphenous vein with an 80-nm diode laser, Dermatol Surg. 2003. 29: 1135–1140.
10. Proebstle TM, Sandhofer M, Kargl A et al. Thermal damage of the
inner vein wall during endovenous laser treatment: Key role of energy
absorption by intravascular blood, Dermatol Surg. 2002. 28: 596–
600.
11. Kabnick LS, Abstract presented at ACP 2004, Miami FL. Is There a
Difference in Endothermal Ablation of the GSV?
12. Puglisi B, Tacconi A, San Filippo F. L’application du laser ND-YAG
dans le traitement du syndrome variquex (Application of the ND-YAG
laser in the treatment of varicose syndrome). In: Davey A, Stemmer R,
eds. Phlebology’89. London:J Libby Eurotext. 1989. 39–842.
13. Wikipedia. Laser. Available at http://en.wikipedia.org/wiki/Laser.
Accessed September 12, 2005.
14. ACEPT W
State University. Color and light. Available at http://acept.la.asu.edu/
PiN/rdg/color/color.shtml. Accessed September 13, 2005.
15. Wikipedia. Wavelength. Available at http://en.wikipedia.org/wiki/
Wavelength. Accessed September 14, 2005. This image is licensed
3
Group. Department of Physics and Astronomy, Arizona
under the GNU Free Documentation License. Available at http://www.
gnu.org/copyleft/fdl.html. Accessed September 14, 2005.
16. University of Tennessee, Department of Physics and Astronomy. The
Electromagnetic Spectrum. Available at http://csep10.phys.utk.edu/
astr162/lect/light/spectrum.html. Accessed September 15, 2005.
17. The Nobel Organization. Laser Challenge, Laser History. Available at
http://nobelprize.org/physics/educational/laser/facts/history.html.
Accessed September 27, 2005.
18. Wikipedia. Laser construction. Available at http://en.wikipedia.org/
wiki/Laser_construction. Accessed September 13, 2005.
19. Wikipedia. Laser diode. Available at http://en.wikipedia.org/wiki/
Laser_diode. Accessed September 14, 2005.
20. Wikipedia. Laser diode. Available at http://en.wikipedia.org/wiki/Pn_junction. Accessed September 26, 2005.
21. Wikipedia. Laser diode. Available at http://en.wikipedia.org/wiki/Nd:
YAG. Accessed September 14, 2005.
22. Wikipedia. Nd:YAG laser. Available at http://en.wikipedia.org/wiki/
Nd:YAG. Accessed September 13, 2005. This image is licensed under
the GNU Free Documentation License. Available at http://www.gnu.
org/copyleft/fdl.html. Accessed September 14, 2005.
23. Spreafi co G, Baccaglini U, Gongolo A, Shariat I, Kabnick L. How and
why the endovenous laser works: Ultrasound and MRI imaging of
veins treated with a 980 nm laser-ELVeS technique. Abstract presented
at International Union of Phebology 15th World Congress; October 7,
2005. Rio de Janeiro, Brazil.
24. Anastasie B, Celerier A, Cohen, Solal G et al. Endovenous laser, Phlebologie. 2003. 56: 369–382.
25. Goldman MP. Intravascular lasers in the treatment of varices veins, J
Cos Derm. 2004. 3: 162–166.
26. Kabnick LS. Outcome of different endovenous laser wavelengths for
great saphenous vein ablation, J Vasc Surg. 2006. 43(1): 88–93.
27. Timperman, PE. Prospective evaluation of higher energy great saphenous vein endovenous laser treatment, J Vasc Interv Radiol. 2005. 16:
791–794.
28. Proebstle TM, Gul D, Kargal A, Knop J. Endovenous laser treatment
of the lesser saphenous vein with a 940-nm diode laser: Early results,
Dermatol Surg. 2003. 29: 357–361.
29. International Registry Working Group, Kabnick LS. EndoLaser Venous
System (980 nm) for the treatment of saphenous venous insuffi ciency:
7611 limbs. 6
together with 30th Annual Congress of the Czech Society of Phlebology.
Prague, Czech Republic. May 2005.
30. Chang C, Chua J. Endovenous laser photocoagulation (EVLP) for
varicose veins, Lasers in Surgery and Medicine. 2002. 31: 257–262.
31. Proebstle TM, Krummenauer F, Gul D, Knop J. Nonocclusion and
early reopening of the great saphenous vein after endovenous laser
treatment is fl uence dependent, Dermatol Surg. 2004. 30: 174–178.
32. Min RJ, Khilnani N, Zimmet S. Endovenous laser treatment of saphenous vein refl ux: Long-term results, J Vasc Interv Radiol. 2003. 14:
991–996.
33. Khilnani NM, Min RJ. Features associated with clinical success with
endovenous laser ablation: Lessons learned from 1000 cases. ACP,
Marco Island, FL. 2004.
34. Proebstle TM, Gül D, Lehr HA, Kargl A, Knop J. Infrequent early
recanalization of great saphenous vein after endovenous laser treatment, J Vasc Surg. 2002. 38: 511.
35. Kabnick LS. New endolaser venous system (980) treatment of long
saphenous vein refl ux: effi cacy and safety. In: Abstracts from the 16th
Annual Congress of the Am College of Phlebology; November 7–10,
2002. Fort Lauderdale, Florida.
th
European American Congress on Venous Diseases,
CHAPTER
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31
VNUS Closure of the Saphenous Vein
NICK MORRISON
INTRODUCTION
Lower extremity varicose vein disease is associated
most often with truncal venous insuffi ciency involving the
saphenous system; the Great Saphenous vein, the Small
Saphenous vein, and/or incompetent perforator or tributary
veins. Management of this disease process historically has
been treated with groin-to-ankle stripping of the Great
Saphenous vein with complete interruption of the tributaries
near the saphenofemoral junction.1 More recent reports of
invagination stripping (PIN) of the Great Saphenous
vein from groin to knee demonstrate comparable results,
with less tissue damage, faster and less painful recovery,
and better cosmetic results than the classic stripping
procedure.
Since 2000, radiofrequency endovenous ablation has
been reported to be a safe and effective method of removing
the proximal portion of the Great Saphenous vein from
the venous circulation, with faster recovery and better
cosmetic results than either the classic or PIN stripping
procedures.
(RF) catheter and generator (VNUS Medical Technologies,
Inc, Sunnyvale, California), delivers electromagnetic energy
to destroy the target vein in situ. Extensive international
experience with this technique has resulted in its rapid
adoption by phlebologists. As a result of this experience
with treatment of the Great Saphenous vein, successful
ablation of the Small Saphenous vein, major tributaries,
and even perforator veins has been reported.4 As with
a stripping procedure, it is important to treat the distal
Great Saphenous vein and incompetent tributary and perforator veins in order to eliminate all major sources of venous
insuffi ciency.
2
3
The Closure® procedure, using a radiofrequency
5
RF Literature
Following extensive animal and clinical investigation,6
clinical trials using RF energy for ablation of the Great
Saphenous vein have demonstrated excellent success rates,
comparable to or better than historical results following
stripping.3 A prospective randomized study directly comparing RF ablation with stripping, reported by Lurie et al.,
confi rmed these fi ndings.7 An earlier report from 2000,15 and
follow-up reports as long as fi ve years post RF ablation4
confi rm the safety and effi cacy of this method of saphenous
vein ablation. Successful ablation rates of nearly 90% or
more routinely are demonstrated,
the United Kingdom has reported an unprecedented 100%
success rate with few complications.
Complications following RF ablation include deep vein
thrombosis (DVT), paresthesia, pain, bruising, leg edema,
localized thermal skin injury, hematoma, and superfi cial
thrombophlebitis. The most serious of these, DVT, generally
is reported to be less than 1%, but has been reported as high
as 20% in one small group of patients.
from 2 to 16%, is usually transitory. The rates of the other
reported complications are low.
9,10
although one center in
11
12
Paresthesia, reported
13
TECHNICAL EQUIPMENT
RF Generator
The generator produces and delivers radiofrequency
energy via a catheter into the vein wall by contact with
retractable electrodes at the end of the catheter, causing
resistive heating of the vein wall suffi cient to denude
the endothelium and denature and shrink the intramural
The Vein Book
283
All rights of reproduction in any form reserved.
Copyright © 2006, Elsevier Inc.
284 Chapter 31/VNUS Closure of the Saphenous Vein
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collagen. Such tissue damage results in fi brotic occlusion of
the target vein, in addition to an infl ammatory response that
enhances vein wall destruction. Heat is produced when the
RF energy causes excitement of the molecules of the vein
wall as it is transmitted from the catheter, into the vein wall,
and back into the central electrode of the catheter. Thus, it
is the impedence in the vein wall to the passage of the RF
energy that causes heat destruction, much like light energy
is produced by the passage of electricity through the fi laments of a lightbulb. A micro-thermocouple mounted on
one of the electrodes continuously measures vein wall temperature and provides feedback to the microprocessor in the
generator. By limiting the temperature to 85 to 90 degrees
Celsius, boiling, vaporization, and carbonization of the
tissues is avoided. In addition, power output and impedence
are also continually monitored to be sure the RF energy is
being effectively delivered to the vein wall. The generator
will automatically shut down if the impedence is so high as
to prevent adequate transmission of RF energy into the vein
wall. The heat generated has been shown to penetrate 1 mm
in tissue, and in the absence of dilute local anesthetic surrounding the Great Saphenous vein, heating of surrounding
tissues can occur by means of conduction. The addition of
the local anesthetic mitigates damage to the surrounding
tissue by conducted heat. The face of the generator displays
elapsed treatment time, vein wall temperature, impedance
(in ohms), and power output, allowing continuous monitoring of several parameters to accomplish successful ablation
of the target vein.
RF Catheter
The catheter, with retractable electrodes to transmit the
radiofrequency energy, is available in two sizes: 6 Fr and
8 Fr. Early in the RF experience, treatment of veins larger
than 12 mm diameter was not recommended. However,
studies in several centers have demonstrated that given adequate ultrasound-guided deposition of dilute local anesthetic
completely surrounding the target vein, successful treatment
of veins much larger than 12 mm is quite feasible.
8
Both
catheters also have a central lumen that allows for passage
of fl uid (often heparinized saline) or a guidewire to assist
advancement of the catheter to the uppermost limit of the
intended treatment.
Pathologic/Physiologic Effects of
Radiofrequency Energy
In his text, Vein Diagnosis and Treatment, Weiss reported
the use of caprine models to evaluate the physiologic and
pathologic changes following RF ablation of the great saphenous vein.
6
Ultrasonographic changes demonstrated by
duplex were occlusion in 100% of veins, and decreased
mean diameter from 5 mm to 1 mm. Acute histologic changes
include “endothelial denudation, thrombus formation, thickened vein walls, denaturation of tissue with loss of collagen
vessel walls, and neutrophil infl ammation.” After six weeks,
abundant new collagen with fi brosis of the vein wall and
encroachment on the vein lumen was seen.
Clinical Experience
Numerous reports by Chandler,15 Pichot,9 Perrin,17
Goldman,13 Bergan,14 Weiss,10 and Kistner3 have shown the
RF ablation procedure to be a safe and effective means of
removing the Great Saphenous vein from the venous system,
with excellent early and mid-term results.
Recently published fi ve-year data from the VNUS registry suggest that the Closure® procedure is effective in
occluding saphenous veins and abolishing refl ux.4 In this
report, patients (22% male and 78% female) with symptomatic saphenous refl ux and a mean saphenous vein diameter
of 7.5 mm, and a maximum of 24 mm, were enrolled in the
registry. Mean age was 47.4 years. Eighty-nine percent of
treated veins were Great Saphenous veins above the knee,
4.1% the entire Great Saphenous vein, and 5.6% were Small
Saphenous and accessory saphenous veins. Vein occlusion
at one year was documented by duplex ultrasound in 87.1%
of legs; 88.2% at two years, 83.5% at three years, 84.9% at
four years, and 87.2% at fi ve years. Major refl uxing tributaries required additional treatment, such as sclerotherapy or
ambulatory phlebectomy.
In a prospective, randomized study reported by Lurie
et al., the RF ablation procedure was compared to the conventional high ligation/stripping procedure with respect to
short-term recovery and cost. Shorter convalescence, less
postoperative pain, and lower overall economic costs were
demonstrated with RF versus surgical ablation.
7
PROCEDURE
Patient Selection
Inclusion criteria should include symptoms and physical
signs of venous insuffi ciency, duplex scan showing a patent
proximal vein with refl ux greater than 0.5 seconds, patent
deep venous system, vein conducive to catheterization
(dependent on the experience of the operator), and fully
mobile patients. Absolute exclusion criteria will include
arteriovenous malformations, restricted ambulation, and
deep venous obstruction. Relative exclusion criteria will
include vein tortuosity, veins less than 2 mm or greater than
25 mm, partial obstruction of the proximal vein, and known
thrombophilia.
Procedure 285
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Technique
Many practitioners have preferred to perform these procedures in the hospital surgical or radiological suites.
Recently, a variety of factors have combined to encourage
displacement of the endovenous ablation procedure from the
hospital and into the offi ce setting. Furthermore, although
the ablation procedure often is performed on veins other
than the Great Saphenous vein, the technical details remain
quite similar. The following description of the procedure for
the great saphenous vein is given with this in mind.
After obtaining informed consent, patients may be given
an oral or intravenous sedative prior to the procedure. The
patient is placed on an adjustable operating table (with
Trendelenburg capability), and the course of the Great
Saphenous vein, from the saphenofemoral junction to the
insertion site, is mapped and marked with an indelible
marker. The insertion site is chosen to maximize treatment
length and to assure facile access.
The portion of the Great Saphenous vein below the knee
is not routinely treated with RF endovenous ablation because
of the increased risk of paresthesia from damage to the
saphenous nerve, which is in close proximity to the vein
below the knee. Access to the Great Saphenous vein may be
made using an ultrasound-guided, percutaneously placed
needle, or via microincision and hooking of the Great Saphenous vein for direct venipuncture. If the percutaneous
method is used, Nitropaste may be applied to the proposed
insertion site prior to the sterile surgical prep to improve
access by dilating the vein and preventing venospasm. It is
sometimes appropriate to choose a primary access site and
a higher, larger diameter, secondary (backup) access site in
case access at the primary site is unsuccessful. Perivenous
or intramural hematoma from unsuccessful attempts at cannulation may render that portion of the Great Saphenous
vein technically inaccessible leading to the need for a secondary site. As the practitioner’s ultrasound-guided technical skills improve, even Great Saphenous veins as small as
2 mm in diameter or less, or more than 25 mm in diameter,
can be cannulated successfully.
The fi rst attempt at cannulation of the Great Saphenous
vein is the most likely to be successful, so the insertion site
should be chosen carefully to make access as ergonomically
feasible as possible. Just below the knee, the Great Saphenous vein is relatively anterior. And with the patient’s operative leg externally rotated, this site becomes more
advantageous than in the distal or mid thigh. And even
though the saphenous nerve is closer to the vein in this area,
the RF catheter sheath will prevent treatment of this portion
of vein, and thus limit the possibility of nerve damage.
Following removal of the Nitropaste, the leg is cleansed,
groin-to-insertion site, with an antiseptic. The operative area
is isolated with sterile drapes. After infi ltration of local anes-
thetic at the insertion site, an introducer needle is inserted
into the Great Saphenous vein under ultrasound guidance;
or a small incision is made and the vein is elevated through
the skin incision with a phlebectomy hook. After advancement of a guidewire into the vein, a 5 cm sheath is advanced
into the vein, and the RF catheter is then advanced to near
the saphenofemoral junction, just below the entrance of the
superfi cial epigastric vein into the Great Saphenous vein,
confi rmed by ultrasound. Occasionally, passage of the RF
catheter may be impeded by vein tortuosity. Usually straightening of the leg or manipulation of the catheter by external
compression, or shifting of the thigh will allow advancement
of the catheter. Segmental stenosis from previous sclerotherapy also will impede advancement of the catherter. In
this case, or if the vein is so tortuous as to not allow passage
of the catheter, a second cannulation, with another insertion
kit, will allow treatment of fi rst the proximal and then the
distal segments of the Great Saphenous vein.
Ultrasound-guided high volume, dilute anesthesia (.1–
.25% Xylocaine with epinephrine/bicarbonate) is then
injected into the saphenous compartment (see Figure 31.1)
from the insertion site up to 3 cm below the saphenofemoral
junction. (Alternatively, higher volume dilute anesthetic can
be injected into the entire thigh generally surrounding the
vein, without the need for ultrasound guidance). The patient
is placed in a moderate Trendelenburg position and the fi nal
position of the tip of the RF catheter confi rmed by ultrasound (see Figure 31.2). The anesthetic solution is injected
into the tissue surrounding the proximal 3 to 4 cm of the
Great Saphenous vein. External hand compression may be
applied to the leg over the tip of the catheter as it is withdrawn. Early in the RF experience, an Esmarck bandage was
used for external compression. However, infi ltration of the
local anesthetic directly into the saphenous sheath under
FIGURE 31.1 Great Saphenous vein, with catheter inside, compressed
by local anesthetic solution.
286 Chapter 31/VNUS Closure of the Saphenous Vein
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TABLE 31.1 Intraoperative Adverse Events
Technical challenges Adverse patient events
Diffi cult access Painful insertion
Trouble threading introducer wire/catheter Dysrhythmia
Treatment interruption Vagal reaction
Unable to reinsert catheter Transient heat
GSV tortuosity Saphenous nerve pain
Aneurysmal segments
TABLE 31.2 Postoperative Adverse Events
(or Expected Sequelae)
Bruising Paresthesia
Skin burn Superfi cial thrombophlebitis
Lymphedema Deep vein thombosis
Infection Intramural hematoma
FIGURE 31.2 SEV = superfi cial epigastric vein, CFV = common femoral
vein.
proximal Great Saphenous vein, and expect the patient’s
ultrasound guidance has largely obviated the need for this
cumbersome step.
The withdrawal rate for the RF catheter is adjusted to
maintain the temperature of the tip at 85 to 90ºC. As the RF
catheter is withdrawn from the distal portion of the treated
segment into the sheath, the impedance will rise rapidly, and
the generator will automatically shut down. On conclusion
of the procedure, Doppler confi rmation of the patency of the
common femoral artery and vein, as well as successful
occlusion of the great saphenous vein with a residual diameter less than 2 mm are recorded. Patients may then be placed
in compression therapy, for example, short-stretch bandages,
and 30–40 mm Hg compression hose (thigh-high or panty—
patient’s preference). Compression should be maintained for
at least several days, if not longer, to enhance successful
ablation. Adjunctive saphenofemoral junction ligation is not
necessary.
Follow-up
Because of the possibility of incomplete ablation or
recurrent patency of the treated vein, and the need for
adjunctive treatment of the distal Great Saphenous vein, the
refl uxing tributaries, and/or Small Saphenous vein, colorfl ow Doppler ultrasound, interviews, and physical examinations at appropriate intervals are needed to assure a
successful outcome. At a minimum, patients should be
examined at one week, six months, and one year following
RF ablation of the Great Saphenous vein. More frequent
follow-up visits often will reveal the need for adjunctive
treatment earlier in the postoperative course, and result in
more complete treatment of the patient’s venous insuffi ciency with better resolution of the patient’s symptom
complex. It is simply not appropriate to merely ablate the
symptoms and varicosities to resolve. Unless one is committed to a program of meticulous follow-up and adjunctive
treatment, the practitioner and the patient will be left with
unsatisfactory results.
Complications are divided into intraoperative and post-
operative adverse events.
Intraoperative adverse events can be divided into technical challenges and adverse patient events (see Table 31.1).
The technical challenges one may encounter are diffi cult
access (venospasm, access location), problems threading the
catheter (vein tortuosity, aneurysmal segments, or sclerosis
from previous sclerotherapy), and treatment interruption
(generator shutdown secondary to high impedence because
of coagulum build-up on the tip of the catheter. This will
require removal of the catheter and cleansing of the tip in
order to restore the fl ow of radiofrequency energy). Adverse
patient events that can occur are dysrhythmia or vagal reaction (often because of anxiety) and saphenous nerve pain or
transient heat (inadequate anesthetic infi ltration).
Postoperative adverse events (or expected sequelae)
include bruising, paresthesia, infection, intramural hematoma, skin burn, superfi cial thrombophlebitis, lymphedema,
and deep vein thrombosis (see Table 31.2). Bruising is
nearly always minimal, and of less than two-week duration.
Unlike following groin-to-ankle stripping, paresthesia following endovenous ablation is usually mild, short-lived, and
limited to the distal thigh. It is seen in 1 to 16% of patients,
and its rate of occurrence is inversely related to the experience of the practioner with ultrasound-guided techniques.
Infection, intramural hematoma, and skin burns are rare,
occurring in less than .1% of patients. These are avoided
Complications
Discussion 287
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with adequate sterile technique. Infection is avoided with
good sterile technique, while the ultrasound guided anesthetic, in ample quantities, will serve to protect the structures
in close proximity to the vein from thermal injury, including
the overlying skin. Superfi cial thrombophlebitis is seen in
less than 10% of cases, and responds to the usual clinical
measures of anti-infl ammatory medication, compression,
and ambulation. Lymphedema has not been reported, but we
have seen it in our own center, and is believed to be caused
from unrecognized impaired lymphatic drainage usually
present prior to any procedures. Treatment of this complication (or more likely sequela) will entail therapeutic lymphatic massage, compression with multilayered low-stretch
bandages and compression hose, and exercise.
Deep vein thrombosis is the most signifi cant complication and is generally reported to occur in less than 1% of the
patients (depending on the duplex scanning interval and the
quality of the examination). Most reported cases are calf
vein thrombosis, and of limited clinical signifi cance. More
proximal thromboses do occur, however, and should be
aggressively searched for and treated. Therapy is usually as
an outpatient, with compression, ambulation, anti-infl ammatory medication or anticoagulation (short term with low
molecular-weight heparin, or longer term with oral agents),
and even percutaneous thrombolytic/thrombectomy therapy
for more proximal thromboses.
One complication, of great interest because of its relative
absence, is neovascularization. Neovascularization commonly is seen following the traditional surgical high ligation
procedure, wherein all tributaries of the great saphenous
vein are carefully dissected and divided.18 This is thought
to be secondary to “frustrated” venous drainage from the
abdominal wall and perineum. The ultrasound picture of
neovascularization, seen as grape-like clusters of veins in
the groin, is quite characteristic (see Figure 31.3). Whether
this is actually the development of new veins, or simply
enlargement of previously existing veins, the result is recurrent refl ux down veins in the thigh and lower leg. The
endovenous ablation procedure deliberately leaves the
superfi cial epigastric vein intact, which, it is believed, has
resulted in few reports of neovascularization at the fi ve-year
interval, or of thrombus extension from the Great Saphenous
vein into the common femoral vein.
DISCUSSION
Considerable confusion in the literature has emerged
regarding the defi nition of successful treatment, the means
used to detect treatment failures, and the reporting of results.
Agreement on the very defi nition of success has not yet been
achieved, being variably reported as sonographic absence of
the target vein,
visible refl ux,9 segmental patency of no more than 5 cm
8
no fl ow in treated segment,19 absence of
Three years post high lig/stripping of
GSV
Morrison Vein Institute
FIGURE 31.3 Block arrow: common femoral vein; Line arrow:
neovascularization.
without refl ux,
advancements in the technology of ultrasound over the past
ten years have allowed far more critical evaluation of clinical results than were possible in the past. As a result of these
advancements, it is now possible to more readily identify
incompletely ablated veins. Recurrent patency can occur
anywhere in the RF-ablated portion of the vein, either along
its length or segmentally. Segmental recurrent patency
usually is seen at the site of an incompetent perforator or a
refl uxing tributary. And because there is likely to be closed
segments above and/or below the patent segment, distal
compression of the closed portion of the vein to identify
refl ux is futile. Likewise, using Valsalva’s maneuver to identify proximal patency is unreliable and lacks reproducibility.
More sensitive and critical ultrasound examination of treated
veins brings into question earlier reports in which success
is defi ned as “absence of visible refl ux” or “resolution of
symptoms.” Indeed, many patients will experience temporary resolution of symptoms following an ablation procedure, only to have those symptoms return when refl ux
becomes clinically signifi cant, generally within a few
months’ time.
Identifi cation of recurrent patency, incomplete ablation,
or treatment failures is very dependent on the sensitivity of
the ultrasound equipment used for postoperative examination, the expertise of the sonographer, and the vigor with
which the examination is conducted. In a study of ultrasound
equipment, from our center, reported at the UIP meeting in
2003, fi ve different ultrasound machines commonly used in
vascular laboratories were evaluated. Six patients with moderate refl ux were examined by the same registered vascular
technologist, using all fi ve machines. The sensitivity of each
machine was found to be 100% (for the control machine),
16
and resolution of symptoms.19 Extensive
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Reflux Sensitivity Comparison
Reflux Sensitivity Comparison
100%
14
12
s
10
e
t
i
S
8
x
u
l
6
f
e
R
4
2
0
Equip D Equip A Equip C Equip B Equip E
FIGURE 31.4 Comparison of sensitivity of duplex equipment.
85%
77%
69%
62%
and 85%, 77%, 69%, and 62% for the other four machines
(see Figure 31.4). In other words, refl ux was not identifi ed
in 15%, 23%, 31%, and 38% of the veins known to have
refl ux. Since identifi cation of fl ow is directly related to the
sensitivity of the duplex machine, it is reasonable to assume
that following patients for postoperative results will be
greatly infl uenced by the equipment utilized for the examinations. Further, the expertise of the sonographer, whether
they have extensive superfi cial venous experience, and how
carefully the examination is carried out are all factors of
paramount importance in critical reporting of results.
Additionally, no consensus has been established on such
critical reporting issues as duration of follow-up and duplex
scanning intervals, quality and sensitivity of duplex equipment used for follow-up examination of a treated vein, and
training and experience of the duplex operator.
Duplex examination for successful ablation of a vein
should include gray scale, compression, and color fl ow
Doppler in order to be complete. However, patients often
have ultrasound-guided foam sclerotherapy for distal segments of the treated vein, refl uxing tributaries of the treated
vein, and incompetent perforators. Such foam sclerotherapy
has had an unexpected effect on critical analysis of successful ablation. Since foam is an excellent contrast medium
with ultrasound, injection of foam into distal vein segments,
tributaries, and incompetent perforators has been very
revealing in following post-ablation patients. The ablated
vein, which remains sonographically identifi able, but by all
duplex ultrasound criteria is completely occluded, com-
monly is found to have foam within the vein following
injection of a tributary, perforator, or distal segment. This
further calls into question even the most critical examination
techniques. Whether these minimally patent segments will
become clinically signifi cant is unanswered at this time. But
certainly patients who complain of localized pain in the area
of a previously ablated vein deserve very careful examination to identify the incompletely ablated segment.
In our own center it has become apparent that most
patients require additional treatment in order to remove all
sources of insuffi ciency from the venous circulation. Adjunctive treatment may include such things as endovenous ablation of the incompetent Small Saphenous vein, accessory
saphenous or major saphenous tributaries, and/or incompetent perforators; ambulatory phlebectomy (or powered phlebectomy); ultrasound-guided sclerotherapy (foam or liquid);
and visual sclerotherapy. These techniques will help to
achieve the greatest resolution of the patient’s varicosities
and symptoms. Much like high surgical ligation of major
tributaries with avulsion phlebectomy distally, and ligation
and/or stripping of the Small Saphenous vein completes the
conventional surgical treatment of high ligation and grointo-knee or ankle stripping of the Great Saphenous vein, these
minimally invasive methods following endovenous ablation
procedures allow more complete treatment of the patient’s
venous insuffi ciency disease.
In our experience of nearly 2000 endovenous ablation
procedures, several important issues have come to light. For
example, any ablated vein segment that remains sonograph-
References 289
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ically visible one year post treatment must still be at least
partially patent. The most effective way to prove recurrent
patency of a segment, and treat it at the same time, is to
search for a perforator or tributary in the area of the visible
segment, and inject foamed sclerosant, under ultrasound
guidance, into the perforator or tributary. The foam will be
seen to course into the visible segment, confi rming its
patency, in spite of a negative examination for fl ow. Because
incomplete ablation is treated when it is identifi ed, it is
unclear if, or how many of, these partially patent segments
would have closed without adjunctive ultrasound-guided
foam sclerotherapy. However, a number of patients who
were found to have recurrent patency, and who were unwilling to have follow-up ultrasound-guided foam sclerotherapy,
have been followed. Over time, most of these patients
have developed recurrent symptoms or signs of venous
insuffi ciency.
Factors we found to be associated with incomplete ablation were preoperative deep venous refl ux and sites of major
tributaries or perforators. Factors found not to be associated
with incomplete ablation were large or aneurysmal segments
and patient age.
It has been reported that most incompletely ablated veins
will be seen in the fi rst few months following treatment,
since failure rates do not steadily increase over time.4
However, we have identifi ed patients more than three years
following apparently successful ablation, with recurrent
symptoms and partially patent segments. Thus, it is necessary to perform thorough follow-up of these patients for one
year, and then either yearly or certainly when recurrent
symptoms occur.
The cost of performing the procedure in the offi ce setting
under local anesthesia, exclusive of the provider’s time, is
generally about $1100.
CONCLUSION
Radiofrequency endovenous ablation is generally safe.
Technical challenges, intraoperative and postoperative
adverse events, and sequelae are infrequent and generally
are seen less frequently than with more traditional surgical
procedures.
Differences in methods of follow-up examination, and in
defi nitions of successful ablation, may help explain differences in results between published reports and in those seen
in the providers’ own clinical setting. Only long-term followup will show where these minimally invasive methods
belong in the therapeutic armamentarium of the treatment
of chronic venous insuffi ciency of the lower extremity.
Although some surgeons have expressed the view that none
of these techniques has yet been shown to better conventional surgery in the long term,
uniformly has been that minimal invasion is better.
20
the patient’s perception
ADDENDUM
Technical Considerations
With respect to treatment of aneurysmal segments of the
GSV, high-volume, dilute anesthetic solution, accurately
placed into the saphenous compartment under ultrasound
guidance, is critical to successful treatment. Very large
GSVs, up to 35 mm, have been ablated successfully with the
RF procedure. It is apparent that well-placed anesthetic solution is the single most important factor in successfully treating GSV incompetence with an ablation procedure. As these
procedures have been performed in the offi ce setting, under
local anesthesia, with minimal oral sedation, it is clear that
well-placed anesthetic solution is also important for the
elimination of the sensation of transient heat felt by the
patient.
Percutaneous, ultrasound-guided access to even very
small GSVs can be achieved, and access times will diminish
quickly and dramatically with experience.
Intramural hematoma at the SFJ has not been previously
described, and after deducing and eliminating inadvertent
SFJ wall puncture during injection of the local anesthetic,
with resultant intramural hematoma, it was not seen again
in this center.
References
1. Sarin S, Scurr JH, Coleridge-Smith PD. Stripping of the long saphe-
nous vein in the treatment of primary varicose veins, Br J Surg. 1994.
81: 1455–1458.
2. Goren G, Yellin AE. Minimally invasive surgery for primary varicose
veins: Limited invaginated axial stripping and tributary (hook) stab
avulsion, Ann Vasc Surg. 1995. 9(4): 401–414.
3. Kistner RL. Endovascular obliteration of the greater saphenous vein:
The closure procedure, Jpn J Phlebol. 2002. 13(5): 325–333.
4. Merchant RF, Pichot O. Long-term outcomes of endovenous radiofre-
quency obliteration of saphenous refl ux as a treatment for superfi cial
venous insuffi ciency, J Vasc Surg. 2005. 42(3): 502–509.
5. Garner JP, Heppell PSJ, Leopold PW. The lateral accessory saphenous
vein—A common cause of recurrent varicose veins, Ann R Coll Surg
Engl. 2003. 85: 389–392.
6. Weiss RA, Feied CF, Weiss MA. Vein diagnosis and treatment.
McGraw-Hill Medical Publishing Division. 2001. 211–221.
7. Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O et al.
Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): Two-year
follow-up, Eur J Vasc Endovasc Surg. 2005. 29: 67–73.
8. Merchant R, Pichot O, Mayers KA. Four years follow-up on endovas-
cular radiofrequency obliteration of saphenous refl ux. Derm Surg.
2005. 31: 129–134.
9. Pichot O, Kabnick LS, Creton D, Merchant RF, Schuller-Petrovic,
Chandler JG. Duplex ultrasound scan fi ndings two years after great
saphenous vein radiofrequency endovenous obliteration, J Vasc Surg.
2004. 39(1): 189–195.
10. Dauplaise T, Weiss RA. Duplex-guided endovascular occlusion of
refl uxing saphenous veins, J Vasc Tech. 2001. 25(2): 79–82.
11. Whiteley M. Radiofrequency treatment for saphenous disease:
Lights and shadows. Presented at the Congress of Phlebology
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and Lymphology, March, 2005. Bologna, Italy (by author’s
permission).
12. Hingorani A, Ascher E, Markevich N, Schutzer R, Kallakuri S, Hou A
et al. Deep venous thrombosis following radiofrequency ablation
(RFA) of greater saphenous vein (GSV): A word of caution. Presented
at the American Venous Forum, February, 2004. Brooklyn, NY, USA:
Maimonides Medical Center.
13. Goldman MP, Miry S. Closure of the greater saphenous vein with
endoluminal radiofrequency thermal heating of the vein wall in combination with ambulatory phlebectomy: 50 patients with more than
6-month follow-up, Derm Surg. 2002. 28: 29–31.
14. Bergan JJ. Endovenous saphenous vein ablation, Adv Vasc Surg. 2001.
9: 123–132.
15. Chandler JG, Pichot O, Sessa C, Schuller-Petrovic S, Kabnick LS,
Bergan JJ. Treatment of primary venous insuffi ciency by endovenous
saphenous vein obliteration, Vasc Surg. 2000. 34: 201–214.
16. Pichot O, Sessa C, Chandler JG, Nuta M, Perrin M. Role of duplex
imaging in endovenous obliteration for primary venous insuffi ciency,
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17. Perrin M. Endovenous therapy for varicose veins of the lower extremities (in French), Ann Chir. 2004. 129: 248–257.
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688–689.
CHAPTER
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32
Treatment of Small Saphenous Vein Refl ux
KENNETH MYERS and AMY CLOUGH
There are more variations of anatomy and pathophysiology
for small saphenous refl ux than at any other site, and these
will be illustrated by fi ndings from duplex ultrasound scanning. There appears to be no consensus as to best treatment
for small saphenous refl ux, in part due to lack of objective
information regarding outcome. What information is available shows poor results from traditional treatment by surgery,
persuading us to recommend that endovenous techniques be
considered.
SURGICAL ANATOMY
The anatomy of veins in the popliteal fossa is highly
variable, unlike the anatomy at the saphenofemoral junction,
which is relatively constant. This section will highlight only
fi ndings relevant to choice and execution of treatment for
Small Saphenous Vein refl ux.
The Small Saphenous Vein (SSV) is always present and
frequently continues as the thigh extension (TE), but there
is a variable connection of the SSV with the deep veins and
a variable termination of the TE. These patterns were well
described by Giacomini in 18731 and have now been clearly
defi ned by ultrasound.
2–8
Small Saphenous Vein (SSV)
The SSV passes up the back of calf in the midline between
the bellies of the gastrocnemius. It is distinguished from
tributaries on ultrasound by the observation that it lies in a
fascial compartment throughout its entire length just as for
the Great Saphenous Vein (GSV).
popliteal or femoral vein at the saphenopopliteal junction
(SPJ) in approximately 75% of limbs.2 The gastrocnemius
8
It turns deep to join the
veins join the SSV rather than the popliteal vein at or near
the SPJ in up to one-third of limbs.
The sural nerve lies just lateral to the SSV but not with
a common association of the perivenous and perineural
fasciae as frequently occurs with the GSV and saphenous
nerve.9 The common peroneal and posterior tibial nerves are
adjacent to the terminal SSV particularly if there is a high
SPJ, with a variable relation lying on either side or even
entwining with the vein.
6
Thigh Extension (TE) and Vein of Giacomini
The embryological pathway for the SSV is up the back
of thigh to the buttock and through the sciatic notch to the
internal iliac vein. Veins at the back of thigh can contribute
to complex patterns of disease and refl ux. The TE is present
in approximately 70% of limbs, is frequently as large as the
SSV, usually extends to the middle or upper thigh, and terminates in almost equal proportions in deep or superfi cial
veins.4 The TE passes up the back of thigh in a groove
between the semitendinosis and biceps muscles in a fascial
compartment just as for the SSV and GSV.
clearly showed that what is now termed the TE may terminate in veins in the buttocks, posterior thigh perforators, or
superfi cial tributaries (see Figure 32.1).1 A communication
of the TE with the posterior circumfl ex thigh vein to connect
to the GSV is now termed the vein of Giacomini. The terminal TE pierces the deep fascia if it passes to deep veins
or passes superfi cial to the membranous fascia if it forms
the vein of Giacomini.
8
1,8
Giacomini
Saphenopopliteal Junction (SPJ)
The SPJ is the proximal end of SSV above the preterminal valve. The SPJ may be rudimentary and is absent in
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291
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