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440 Techniques and results of the modern surgical treatment of the incompetent saphenous vein
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●
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54. Biswas S, Clark A, and Shields DA. Randomised
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after varicose vein surgery. Eur J Vasc Endovasc Surg
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55. Aromaa U and Asp K. A comparison of naproxen,
indomethacin, and acetylsalicyclic acid in pain after
varicose vein surgery. J Int Med Res 1978;6:152–6.
56. Lurie F, Creton D, Eklöf B etal. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping
in a selected patient population (EVOLVeS study).
JVasc Surg 2003;38:207–14.
57. Corder AP, Schache DJ, Farquharson SM, and
Tristram S. Wound infection following high saphenous ligation: A trial comparing two skin closure
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58. Hirsemann S, Sohr D, Gastmeier K, and Gastmeier
P. Risk factors for surgical site infections in a freestanding outpatient setting. Am J Infect Control
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59. Cox SJ, Wellwood JM, and Martin A. Saphenous
nerve injury caused by stripping of the long saphenous vein. Br Med J 19 74;1(905):415 –7.
60. Holme JB, Skajaa K, and Holme K. Incidence of
lesions of the saphenous nerve after partial or complete stripping of the long saphenous vein. Acta Chir
Scand 1990;156:145– 8.
61. Morrison CL and Dalsing MC. Signs and symptoms
of saphenous nerve injury after greater saphenous
vein stripping: Prevalence, severity, and relevance
for modern practice. J Vasc Surg 2003;38(5):886–90.
62. Atkin GK, Round T, Vattipally VR, and Das SK.
Common peroneal nerve injury as a complication of short saphenous vein surgery. Phlebology
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63. Rudstrom H, Bjorck M, and Bergqvist D. Iatrogenic
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64. Hagmuller GW. Complications in surgery of varicose
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65. van Rij AM, Chai J, Hill GB, and Christie RA.
Incidence of deep vein thrombosis after varicose
vein surgery. Br J Surg 2004;91:1582–5.
66. Milone M, Maietta P, Bianco P etal. Safety and
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67. Miller GV, Lewis WG, Sainsbury JR, and Macdonald
RC. Morbidity of varicose vein surgery: Auditing the
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Long-term results after vein surgery. Study of 1,000
cases after 10 years. Mayo Clin Proc 1974;49(2):114–7.
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69. Winterborn RJ, Foy C, and 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(4):634–9.
70. Disselhoff BC, der Kinderen DJ, Kelder JC, and
MollFL. Randomized clinical trial comparing endovenous laser with cryostripping for great saphenous
varicose veins. Br J Surg 2008;95:1232–8.
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71. Perrin MR, Guex JJ, Ruckley CV etal. Recurrent varices after surgery (REVAS), a consensus document.
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72. Fischer R, Chandler JG, De Maeseneer MG etal. The
unresolved problem of recurrent saphenofemoral
reflux. J Am Coll Surg 2002;195:80–94.
73. Allegra C, Antignani PL, and Carlizza A. Recurrent
varicose veins following surgical treatment: Our
experience with five years follow-up. Eur J Vasc
Endovasc Surg 2007;33:751– 6.
74. Perrin MR, Labropoulos N, and Leon LR Jr.
Presentation of the patient with recurrent varices
after surgery (REVAS). J Vasc Surg 2006;43:327–34.
75. Fischer R, Linde N, Duff C etal. Late recurrent
saphenofemoral junction reflux after ligation and
stripping of the greater saphenous vein. J Vasc Surg
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and Michaels JA. Randomised and economic analysis
of conservative and therapeutic interventions for varicose veins study. The outcome of varicose vein surgery
at 10 years: Clinical findings, symptoms and patient
satisfaction. Ann R Coll Surg Engl 2003;85:52–7.
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of surgery and compression with compression
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References 441
79. Lurie F, Creton D, Eklöf B etal. 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.
●
80. Rasmussen LH, Bjoern L, Lawaetz M etal.
Randomized trial comparing endovenous laser
ablation of the great saphenous vein with
high ligation and stripping in patients with
varicose veins:Short-term results. J Vasc Surg
2007;46:308–15.
81. de Medeiros CA and Luccas GC. 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;31:1685–94.
82. Pronk P, Gauw SA, Mooij MC etal. Randomised controlled trial comparing sapheno-femoral ligation and
stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent
anaesthesia: One year results. Eur J Vasc Endovasc
Surg 2010;40:649–56.
★
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J, andFraser C. Systematic review of foam
sclerotherapy for varicose veins. Br J Surg
2007;94:925–36.
★
84. Murad MH, Coto-Yglesias F, Zumaeta-Garcia M
etal. A systematic review and meta-analysis of the
treatments of varicose veins. J Vasc Surg 2011;53
(Suppl.2):51S–67S.
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37
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Radiofrequency treatment of the incompetent
saphenous vein
ALAN M. DIETZEK AND STUART BLACKWOOD
37.1 Introduction 443
37.2 The closure system and RFA procedure 444
37.3 RF procedure outcomes 446
37.4 Procedure safety and complications 447
37.5 Contraindications to RFA 449
37.1 INTRODUCTION
Chronic venous disease (CVD) is one of the most common vascular diseases to aect a patient’s health and quality
of life(QoL). It is estimated that the prevalence of varicose
veins is as high as 20%–60%1 and that over 25 million
Americans are concerned by chronic venous insuciency
(CVI).2 e symptoms and signs of this disease are varied, and range from mild to disabling. ey include varicose veins, leg swelling, skin discoloration, thickening
of the skin, and, in the most advanced cases, ulceration.
Consequently, CVD and its more severe form, CVI, have
resulted in U.S. annual health care expenditures in the billions of dollars.
Reux in the great saphenous vein (GSV) is one of the
most frequent causes of primary CVD. Prior to endovenous
ablation, surgical stripping of the GSV was the accepted standard for the management of symptomatic supercial venous
insuciency. is intervention was associated with signicant morbidity, post-operative pain, and prolonged recovery
times. Radiofrequency ablation (RFA) for treatment of the
incompetent saphenous vein was rst introduced in Europe
in 1998 and approved for use in the United States by the Food
and Drug Administration (FDA) in 1999. RFA is a minimally
invasive alternative to saphenous vein ligation and stripping.
Since its introduction, the procedure has become increasingly popular as it oers equal ecacy, decreased morbidity, a milder recovery course, and greater patient satisfaction
when compared to saphenous vein stripping.
Following stripping and ligation of the GSV at the saphenofemoral junction (SFJ), varicose vein recurrence aects
3
37.6 Recurrence rates and treatment failure 449
37.7 Other RF devices 450
37.8 Conclusions 451
References 451
15%–30% of patients. e primary cause is neovascularization.
vascularization frequency is much reduced.
performed detailed ultrasonographic analysis of the GSV
in patients receiving RFA over a 2-year period. e most
common observation at the SFJ was a short patent stump
conducting anterograde tributary ow through the SFJ with
an obliterated GSV trunk.6 is patent stump is believed to
serve as a conduit to preserve the normal physiologic ow
from one or more patent tributaries such as those draining
blood from abdominal and pudendal areas. Following RFA
of the GSV, it has become clear that reux at the SFJ can be
eliminated without groin dissection or ligation of secondand third-order tributary branches. Preservation of such
physiologic ow has been considered to be an advantage of
endovenous procedures over traditional vein stripping as it
causes less hemodynamic disturbance, which is thought to
be one of the factors responsible for stimulating neovascularization following vein stripping.
eral randomized trials which have compared endovenous
RFA with surgical stripping or endovenous laser therapy
(EVLT) of the saphenous vein. All have demonstrated RFA
to have equal or better outcomes, and will be reviewed in
greater detail later in this chapter.
there has been only one RFA device available in the United
States and approved by the FDA for use in supercial veins,
albeit with modications and dierent manufacturers over
time (Closure and ClosurePlus™ [CP]—VNUS Medical
Technologies, San Jose, CA; and ClosureFast™ [CLF]—
Venet™ Covidien, Manseld, MA). All references to RFA in
4
Following endovenous ablation via RFA, the neo-
Over the course of the past 15 years, there have been sev-
7–15
5,6
Pichot etal.
Until very recently,
443
444 Radiofrequency treatment of the incompetent saphenous vein
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this chapter are concerning these devices. At present, other
RFA devices for use in saphenous vein ablation are under
dierent phases of FDA evaluation. ey will be briey
reviewed.
37.2 THE CLOSURE SYSTEM AND RFA
PROCEDURE
37.2.1 Mechanism of action
e rst-generation RFA catheters (CP) utilized bipolar
electrodes at the tip of the catheter to apply to the vein wall
an alternating electrical current at a frequency of 200–
1200 kHz (Figure 37.1). e vein wall acted as a conductor
with a known resistance, thus converting radiofrequency
(RF) energy into thermal energy, resulting in heating of the
vein wall. is caused denaturation of the collagen in the
vein wall with resultant contraction of the vessel and obliteration of the vessel lumen. To transfer electrical current,
there had to be good apposition of the catheter electrodes
to the intraluminal vein wall.16 With the RF energy activated, the catheter was withdrawn slowly (2–3 cm/minute)
in order to ensure an adequate treatment to the vein wall.
A thermocouple located on the electrodes monitored the
temperature and provided continuous feedback to a generator, which, in turn, adjusted power delivery to maintain a
temperature of either 85°C or 90°C. With widely accepted
clinical success notwithstanding, the rst-generation CP
catheter suered from very slow treatment times in comparison to laser ablation. Because of the necessarily slow
catheter pullback speeds and not infrequent generator
“shut-os” when impedance surpassed a predetermined
threshold, treatment times would oen exceed 30 minutes.
Additionally, results were occasionally inconsistent because
of poor contact between the electrodes and the vein wall,
with either ineective closure of the saphenous vein or early
recanalization.
In 2007, the current-generation CLF segmental ablation catheter replaced the bipolar electrode catheter. e
CLF catheter has a 7-cm heating element at its tip which
is heated to 1200°C by RF energy supplied through a RF
generator (RFG) (Figure 37.2). During energy delivery, the
catheter remains stationary for a period of 20 seconds. By
conductive heat transfer, the vein wall segment in contact
with the 7-cm catheter heating element reaches a temperature of 100–110°C. e catheter is then moved distally in
6.5-cm increments, thus achieving a 0.5-cm treatment overlap zone at each treated segment. is segmental technique
signicantly increases the procedure speed and eectiveness in part by eliminating operator variability. A 45-cm
vein can be treated in 3–5 minutes, on par with the fastest
endovenous laser protocol. A shorter 3-cm heating element
design is available for shorter vein segments (Figure 37.2).
e manufacturer currently produces a 60-cm length catheter for both sizes of heating elements and a longer 100-cm
catheter option for the 7-cm heating element only.
Although there have been signicant changes in design
since the rst RFA device, the present segmental ablation
catheter maintains the temperature feedback loop and thus
controlled energy delivery. Impedance is monitored but not
displayed. Displayed on the RFG are the temperature at the
vein wall and the amount of power in watts required. High
power (watts) may indicate poor contact with the vein wall,
which is likely to occur with less-than-optimal exsanguination or poor vein compression onto the catheter. In this
circumstance, the generator will display an advisory message prompting technical correction. e RFG (Figure 37.3)
also allows close control of the temperature range to avoid
undesirable eects of overheating such as boiling, coagulation, vaporization, and carbonization of the tissues. e
procedural steps are quite simple, and, most importantly,
there is no need for continuous pullback of the catheter during energy delivery. is eliminates most of the variability
in energy delivery to the vein wall, thus ensuring consistent
treatment outcomes.
e endovenous RFA procedure is performed using both
local anesthesia for vein access and perivenous tumescent
anesthesia with or without sedation depending upon physician practice and patient anxiety. Percutaneous vein access
is performed under duplex ultrasound guidance. ermal
damage to the vein wall leads to thrombosis and brosis of
the vein and a durable closure of the vein over time. Lessthan-optimal contact between the catheter and vein wall
such as is seen with inappropriate treatment of aneurysmal
segments of vein (>3 cm in diameter) using RFA may lead to
supercial phlebitis in the short term and treatment failure
in the long term, with restoration of ow and suboptimal
clinical outcomes.
17
Figure 37.1 Bipolar heating element design of the original
ClosurePlus device.
6F 8F
37.2.2 Technique of saphenous ablation:
Using the segmental ablation
catheter
Once venous access is obtained, a 7-Fr sheath is placed
and the catheter is inserted through the sheath into the
vein to be treated (Figure 37.4a and 37.4b). Any resistance
to catheter passage through the vein should prompt alternative strategies to navigate venous tortuosity, as this will
avoid patient discomfort and possible vein perforation.
37.2 The closure system and RFA procedure 445
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7 cm
Figure 37.2 7- and 3-cm long heating elements of the newer ClosureFast segmental ablation catheter.
Techniques we employ routinely for this situation include
gentle compression on the tissues over or proximal to the
catheter tip to change its direction and or straightening
or bending of the extremity to change the position of the
vein. If these maneuvers fail either, a standard 0.025-inch
or 0.018-inch guidewire will generally prove successful at
crossing the tortuous segment. If all of these measures are
unsuccessful, a second sheath is placed proximal to the tortuous vein segment. Together, these measures add no signicant morbidity and very little time to the procedure.
Once the entire vein is traversed with the RF catheter, the
tip is pulled back to a minimum of 2 cm from the SFJ. When
treating the small saphenous vein (SSV), the catheter tip is
positioned at the point where the vein begins to turn down
in its course towards the saphenopopliteal junction. is
is usually signicantly more than 2 cm from the junction.
With the earlier-generation CP catheters, the tip was oen
positioned closer to the junction with either the femoral or
popliteal veins because there was less forward heating with
this catheter than the present CLF catheter (Figure 37.4c
and 37. 4 f ).
e key to the performance of almost all in-oce vein
7 cm
procedures, other than sclerotherapy, is the use of tumescent anesthesia. is enables the delivery of large amounts
of dilute anesthesia without the risk of lidocaine toxicity.
Consequently, large treatment areas can be anesthetized for
treatment. With the RF procedure, tumescent anesthesia is
delivered into the perivenous space (Figure 37.4d through
37.4f). Adequate tumescence (approximately 10 mL/cm
vein) is important for three reasons: rst, it provides vein
compression, which improves the vein wall to catheter
contact that is necessary for RF ablation; second, it provides anesthesia and thereby improves patient comfort;
and third, it acts as a heat sink around the treated vein, preventing injury to the surrounding skin and so tissues and
nerves. is is reected in the extremely low incidence of
skin burns and paresthesiae discussed later in this chapter.
With the CLF catheter, energy delivery can be initiated by
pressing a button on the catheter handle rather than on the
generator (Figure 37.4g and 37.4i). is allows the operator
Figure 37.3 The new ClosureFast catheter and radiofre-
quency generator.
to initiate treatment and eliminates the need for an assistant for this task as was necessary with earlier-generation
3 cm
446 Radiofrequency treatment of the incompetent saphenous vein
)(
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(a) (b
(d)
Cross-section view
(g) (h) (i)
Cross-section view
Figure 37.4 (a–i) Procedure technique of radiofrequency ablation using the segmental ablation catheter.
catheters. External compression over the heating element is
important as an additional measure to bring the vein wall
into contact with the heating element of the catheter, and
can be achieved with most duplex probes (Figure 37.4g and
37.4h). With the default setting, the generator automati-
cally terminates the energy delivery aer 20 seconds. e
catheter is then moved to the next 6.5-cm segment for treat-
(e) (f )
Cross-section view
Cross-section view
7 cm coil length
the deep venous system.18 Subsequent physician awareness
and treatment modications have reduced the incidence of
clinically relevant EHIT aer RFA to between 1% and 2%,19
with symptomatic pulmonary embolism rates reportedly
far lower at 0.03%.20 New literature is emerging that suggests that the strategy of routine post-operative duplex may
become obsolete as it appears to be cost-ineective.
c)
Cross-section view
2 cm
3 cm coil length
ment. Sha markers on the catheter guide the catheter repositioning during the treatment. An additional energy cycle
37.3 RF PROCEDURE OUTCOMES
is applied at the rst vein segment near the junction. We will
also apply additional treatment cycles to dilated vein seg-
37.3.1 Saphenous vein occlusion
ments and to those areas with signicant tributaries. Aer
the catheter is moved out of the treatment zone, it should
not be re-advanced into an acutely treated area. Immediate
vein wall thickening and vein occlusion are expected on
completion of the treatment.
RFA treatment ecacy has been well documented, with
short- to mid-term ecacy rates of 90%–100%.
e longest published follow-up results are from the VNUS
Clinical Registry using rst-generation bipolar technology
and those from the recently reported latest-generation RF
37.2.3 Post-operative care
Patients are advised to ambulate immediately aer the procedure, and it has been our practice to have patients wear
compression hose for a minimum of 1 week, although
admittedly there is little evidence to support this protocol. A completion duplex scan is then performed within 72
hours to assess for thrombus extension from the recently
treated supercial vein into the deep system. e use of routine post-operative duplex scanning, however, is an area of
some controversy as well, because of the very low incidence
of deep vein thrombosis (DVT) following these procedures
segmental ablation ClosureFast Registry. Both registries
followed patients for up to 5 years and demonstrated vein
occlusion rates of 87% and 94.9% and reux free rates of
84% and 91.9%, respectively.
30,31
Treatment ecacy with segmental ablation on largediameter veins has also been evaluated, but only in the short
term and in one publication.32 In this study, the authors
retrospectively reviewed their 6-month saphenous vein
occlusion rates in veins ≤12 mm (mean: 8 ±2 mm) against
veins >12 mm (mean: 17 ±4 mm) with the use of the seg-
mental ablation catheter. Both groups achieved 100% vein
occlusion.
and the abundant evidence that most of these thrombus
extensions resolve without treatment. us, why perform
any testing? At the present time, we do so for medicolegal
37.3.2 Clinical outcomes (quality of life and
patient satisfaction)
reasons. It has been suggested that most of these thrombus
extensions are not true DVTs at all. In 2006, Kabnick etal.
identied a new clinical entity named endovenous heatinduced thrombosis (EHIT) and suggested a protocol for
treatment based on the degree of thrombus extension into
e treatment of saphenous vein reux by RFA is less painful
for patients than conventional surgery and patients recover
faster. RFA appears to confer a mild benet compared to laser
in the early post-operative period, mostly related to pain,
21
7,8,12,14,22–29
37.4 Procedure safety and complications 447
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Table 37.1 Effectiveness of radiofrequency ablation for varicose vein symptoms, impact on quality of life, and patient
satisfaction with radiofrequency ablation
Early
Study
Rautio etal.
Lurie etal.
Treatment
(limbs)
7
CP (15) NR 8 weeks NR Favored RFA
occlusion
rate
S&L (13)
8
CP (45) 95% 4 months Not significantly different 3 and 7 days
Maximum
follow-up
Radiographic or clinical
recurrence
a
Patient satisfaction (QoL)
8 weeks
at follow-up
S&L (36) 100%
Lurie etal.
24c
CP (36) NR 2 years 1 and 2 years
S&L (29) NR
Perala etal.
9d
CP (15) NR 3 years NR
S&L (13) NR
Hinchliffe etal.
10
CP (16) 81% 6 weeks
S&L (16) 88%
Kianifard etal.
11
CP (55) 100% 1 year
S&L (55) 100%
Stötter etal.
14
CP (20) 95% 1 year Favored RFA
S&L (20) 100%
Subramonia etal.
13
CP (47) 100% 5 weeks NR
S&L (41) 83%
Helmy ElKaffas etal.
12
CP (90) 94.5% 2 years Not significantly different NR
S&L (90) 100%
Note: QoL: quality of life; RFA: radiofrequency ablation; S&L: stripping and ligation; CP: ClosurePlus; NR: not reported.
a
Venous Severity Improvements based on CEAP, VCSS.
b
Survey methods included CIVIQ-2 (Chronic Venous Insufficiency Questionnaire-2), RAND-2 (RAND Short Form 36), AVVQ (Abderdeen
Varicose Vein Questionnaire), EQ-5D (EuroQuol 5-Dimensional), and SF-12 (Short Form 12).
c
Follow-up study of Lurie etal.
d
Follow-up study of Rautio etal.
8
7
b
although this is generally short lived. Table 37.1 summarizes
patient satisfaction based on randomized controlled trials
comparing RFA to surgery or endovenous laser. Rautio etal.
reported signicantly less post-operative pain, quantied
with a visual analog scale (VAS), in the RF group compared
to the stripping group at rest (P = 0.017), in a standing position (P = 0.026), and when walking (P = 0.036), with the
greatest dierences at the 5th to the 14th post-operative
day.7 e analgesic needed in the RF patients was 0.4 ± 0.49
tablets of 600 mg ibuprofen per day, and in the stripping group was 1.30 ± 1.09 tablets (P = 0.004). Sick leaves
were also signicantly shorter in the RF group (6.5 ± 3.3
vs. 15.6 ± 6.0 days, P < 0.001), and physical function was
restored faster in the RF patients, measured with RAND
short form 36 QoL questionnaires. A multicenter study
from ve centers in the United States and Europe (EVOLVeS
study) conrmed signicant advantages of the closure procedure compared to conventional surgery, with less postoperative pain for up to 3 weeks, earlier return to activities
and work, and better cosmetic results. Patients returned to
either normal daily activities or to work at a mean time of
3 days, 8 days earlier than patients treated with surgery.
8
A
2-year follow-up study showed that QoL scores were superior in the RFA group at 1 year, and remained signicantly
better 2 years aer treatment.24 Similar clinical outcomes
were observed at 2 years with RFA and surgery, as assessed
by CEAP classication and Venous Clinical Severity Score
(VCSS). e newer CLF catheter appears to confer the same
mild convalescence as the previous generation catheters.
e RECOVERY study compared patient recovery following saphenous RF versus EVLT with a 980-nm laser ber in
the immediate post-operative period with respect to pain,
bruising, and pre-operative and post-operative QoL using
the Chronic Venous Insuciency Questionnaire-2 (CIVIQ-
2) tool. Patients treated with RF did statistically better than
EVLT patients in categories of pain, bruising, and QoL in
the early post-operative period. is benet disappeared at
30 days.29 ere was a greater reduction in VCSS at 48 hours
(4.7 vs. 6.2), 1 week (4.2 vs. 5.9), and 2 weeks (4.0 vs. 5.3) for
RFA as compared to laser. Reduced pain and post-operative
edema were thought to be the main contributing factors to
the improved VCSS ratings. e dierence in VCSS ratings
was also limited to 30 days.
8,24,29
37.4 PROCEDURE SAFETY AND
COMPLICATIONS
RFA was the rst endovenous ablation technology available for wide clinical use. e procedure’s safety was carefully investigated and reported in early and mid-term
448 Radiofrequency treatment of the incompetent saphenous vein
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publications.
7,8,14,23–26
A clinical registry was established in
1998 to monitor the procedure’s safety and document treatment outcomes. As experience accumulated, a number of
procedural modications were implemented to minimize
potential risks and increase treatment ecacy. A systematic review conducted by the Ontario Ministry of Health in
2011 found that approximately 2.9% (105/3664) of patients
who undergo RFA of the saphenous vein will have a major
adverse event.33 However, of these patients, only 13.7% (504)
were treated with the newer CLF device. Newer studies
using the CLF catheter report complication rates of <2%,
with most complications being minor, such as skin burns,
paresthesiae, and thrombophlebitis (Table37.2).
37.4.1 Superficial venous thrombophlebitis
Phlebitis can occur with the closure procedure as a result
of residual blood trapped within vein segments. It is occasionally seen as a tender, erythematous, or ecchymotic band
over the treated vein in the distal thigh and is self-limiting,
with treatment needed only for symptom relief. In a comparative study of 667 RFA procedures, the rate of supercial
venous thrombophlebitis (SVT) was 15% for the original
CP catheter and 10% for the CLF catheter.34 Similar rates
of SVT were observed in a large randomized controlled
trial comparing 500 patients treated with EVLT, RFA, foam
sclerotherapy, and stripping of the GSV. SVT occurred in
12 patients (9.6%) undergoing RFA.35 Other studies have
found a lesser degree of phlebitis aer RFA and a reduced
incidence with the newer-generation catheter.
32,36
Calcagno
et al. reported a 4% rate of clinically signicant phlebitis
aer RFA,32 and an industry-sponsored multicenter prospective study identied only two out of 254 limbs (0.8%)
that had developed clinically signicant SVT aer ablation
of the GSV using the CLF catheter.
36
37.4.2 Bruises and burns
With the development of RFA, it became evident that thermal damage would be a major cause of side eects (major or
minor). In early studies, full-thickness skin burns occurred
in between 2%23 and 4%26 of treated limbs. Tumescent inltration was introduced to address the skin burn risk. Aer
the implementation of tumescent anesthesia, and with
appropriate patient selection (see Section 37.5), skin burns
are rarely observed today. Bruising is less frequent aer RFA
compared to stripping procedures. In one small randomized trial, 16 patients with bilateral recurrent GSV incompetence aer high ligation were randomized to RFA on one leg
versus conventional surgery with stripping of the GSV on
the other leg. Bruising scores were measured using patient
VAS, as well as digital image analysis soware, to calculate
the percentage of leg discolored aer treatment. Aer conventional surgery, 21.8% of the leg was bruised compared to
11.9% (P = 0.02) with RFA using the CP catheter; in addi-
tion, patients also perceived less bruising based on a VAS.10
More recently, this issue was re-examined using the newer
CLF catheter in the RECOVERY study. Moderate to severe
ecchymosis dened as >25% of the treated surface area
occurred in one out of 46 (2.2%) of patients using the CLF
catheter compared to 21 out of 41 (51.30%) patients treated
with a 980-nm laser.
29
37.4.3 Nerve damage and paresthesiae
Prior to the routine implementation of tumescent inltration, paresthesia—oen described as focal hypoesthesia—
was reported in approximately 9%–19% of limbs within
1 week of the procedure, and this gradually resolved over
7,8,14,22–27
time.
resolve; the Closure Study Group found a 15% rate of paresthesiae at 1 week (43/286), of which 5.6% (8/142) persisted
at the 2-year follow-up.30 Perivenous tumescent inltration eectively eliminates this complication.24 Limiting
treatment to the above-knee saphenous vein also markedly decreases the risk of paresthesia by avoiding potential
thermal injury to the saphenous nerve, which most oen
lies adjacent to the saphenous vein below the knee.26 If the
saphenous vein is to be treated below the knee, great care
should be taken to administer adequate tumescent anesthetic and, if possible, to identify the saphenous nerve with
duplex and separate it from the vein with tumescence.
It must be noted that not all paresthesiae
5
Table 37.2 Safety profile of radiofrequency ablation
Complication ClosurePlus (selected studies) ClosureFast (selected studies)
SVT 0.8%–15% [30,34–36] 0%–10% [32,34–37]
DVT 0%–3.5% [7,8,23,26,33,34] and 16%
PE 0.02% [26] 0%–rare [33]
Thermal injury 0%–4% [26,33] 0% [33]
Nerve damage and paresthesiae
(early and late)
Wound infections 0%–rare [33] 0%–rare [29,33]
Bleeding 0%–rare [33] 0%–rare [33]
Note: SVT: superficial venous thrombophlebitis; DVT: deep vein thrombosis; PE: pulmonary embolism.
a
Most studies report 0%–2% rates, with one outlier study.
a
[38] 0%–1% [34]
9%–19% [7,8,14,22–27] 1%–3.4% [32,36,39]
37.6 Recurrence rates and treatment failure 449
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37.4.4 DVT and pulmonary embolism
DVT is always a potential risk of any surgical procedure. In
a retrospective study, the incidence of DVT aer open varicose vein surgery was approximately 5.3% in 377 patients.40
e majority of DVTs in this study were in the calf and had
no evidence of propagation or embolism. e situation is
very dierent for thrombosis occurring in the setting of
RFA. In the case of endovascular obliteration, thrombus
can originate from the treated supercial vein and extend
into the much larger femoral venous system. Careful catheter tip positioning is crucial and should be >2 cm distal to
the SFJ and the ostium of the supercial epigastric tributary.
is minimizes the risk of DVT and preserves physiologic
blood ow from the tributary. Immediate and sucient
ambulation is emphasized, and routine ultrasound scanning within 72 hours post-operatively to rule out DVT is
still recommended, although this practice is controversial, as discussed previously. DVT rates are reported to be
0%–2% in the majority of published series which are, for
the most part, with the use of the earlier-generation bipolar
catheters.
7,8,14,22–28
In one series, the DVT rate was 16.4% (12
of 73), but this is an exception from the experiences of others.38 In a comparative study, there were no cases of DVT
detected in those patients treated with the segmental ablation CLF catheter, whereas DVT occurred in 3.5% of cases
treated with the previous-generation bipolar CP catheters.
34
37.4.5 Wound infection
Wound infections are very rare complications of endovenous ablative procedures. In the RECOVERY study, for
example, no patient in either group (laser vs. RFA) developed a wound infection.
29
scarred veins, thrombosed veins, and aneurysmal veins may
be contraindications for the RFA procedure, all for purely
mechanical reasons. Acute thrombosis of the saphenous
vein is a contraindication to RFA as the catheter should not
be advanced directly through acute thrombus. In the case
of small or tortuous veins, the catheter may not be able to
traverse the lumen. Large aneurysmal segments of vein will
not allow for adequate apposition between the vein wall and
the heating element of the catheter. When treated with RFA,
thrombus formation and SVT oen occur. erefore, aneurysmal segments are best managed by surgical excision.
Treatment with RFA of diusely enlarged saphenous veins
of >2 cm is very uncommon and prone to fail unless certain
measures are taken. Techniques used to overcome this problem include compression with ultrasound during heating,
use of additional tumescence, Esmark exsanguination of
the leg, adoption of the Trendelenburg position, and/or leg
elevation throughout the procedure. In general, we would
not recommend RFA for veins >2.5 cm in diameter. Failure
to achieve satisfactory compression should prompt the surgeon to perform an alternative endovenous technique or
high ligation and stripping of the saphenous vein. Patients
who have previous chronic SVT of the saphenous vein who
have had excessive scarring and synechiae formation within
the vein may not be candidates simply because the catheter
may not be able to pass through these areas. Another relative contraindication to RFA is a saphenous vein which is
very supercial. In this circumstance, adequate tumescent
anesthesia will prevent a skin burn, but will usually not
prevent staining and dimpling of the overlying skin. is
should be discussed in detail with the patient prior to the
procedure and a surgical option should be oered. Other
contraindications to RFA include pregnancy, inability to
ambulate, poor general health, and acute DVT.
37.4.6 Bleeding and hematoma
Risk of bleeding appears to be small and not clinically signicant in patients undergoing RFA of the saphenous vein.
If there is any bleeding, it is minor and self-limiting. In one
relatively small, non-randomized, prospective study, periprocedural bleeding in patients who underwent either EVLT
or RFA while on anticoagulation (n = 88) was compared to
that in a control group not on anticoagulation (n = 92). e
authors found that the only group with a statistically signicantly higher rate of bleeding was the group undergoing
RFA while on “triple therapy” using aspirin, clopidogrel,
and warfarin. No major bleeding occurred. e study was
underpowered to detect a dierence between the two dierent types of ablation techniques.
41
37.5 CONTRAINDICATIONS TO RFA
Despite great enthusiasm regarding RFA for the treatment
of GSV reux and varicose veins, there are several important scenarios in which RFA might be not optimal or is contraindicated. Small-diameter (<2.5 mm) or tortuous veins,
37.6 RECURRENCE RATES AND
TREATMENT FAILURE
Treatment failure can be divided into two groups: hemodynamic failure and clinical failure. Early hemodynamic
failure following surgical stripping is due to incomplete
saphenous vein removal, whereas in the case of RFA, this
is due to inadequate vein ablation. Delayed hemodynamic
failure aer surgery is primarily due to neovascularization
and is recognized as one of the principal causes of recurrent
reux and disease progression aer stripping of the saphenous vein.
clinical recurrence and accounts for 85% of recurrent SFJ
reux.
tion was already evident at 2 years.
was reported in one (2.8%) RFA limb and four (13.8%)
stripped limbs (P < 0.05) in the EVOLVeS study.8 A lower
incidence of neovascularization with RFA was also reported
by Pichot et al.
detailed ultrasound scan protocol and found no evidence of
neovascularization at 2 years aer RF treatment. Two major
advantages of RFA that are thought to account for the low
42–45
It occurs in more than 50% of limbs with
46,47
Furthermore, 90% of observed neovasculariza-
6
ey carefully studied 63 limbs with a
47, 48
Neovascularization
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