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Chapter
https://t.me/med1917
11
Intravascular Approaches to the Treatment of Varicose Veins: Radiofrequency and Lasers
304
ambulation have reported similar results with virtually no
DVT. A DVT was noted in a female patient treated using
tumescent anesthesia while awake but she weighed more than
350 pounds and did not ambulate after the endoluminal RF
procedure.
38,39
Salles-Cunha et al35 reported on the development of angiogenesis and fibrotic tissue along the course of the GSV
treated with RF Closure. Contrary to this report, our experience with tumescent anesthesia utilized is a complete lack of
detection of small vessel networks (angiogenesis) by duplex
ultrasound. We believe that the reason for our lack in detecting small vessel networks is not from a lack of trying to see
them, but from the minimization of inflammation that occurs
with tumescent anesthesia placed in the perivascular space
during either RF or laser endothelial ablation.
40
We have not performed ligation of the SFJ in any of our
over 1000 patients and question the accuracy of the findings
of Salles-Cunha et al, who found a decreased incidence of
small vessel networks in patients whose SFJs were ligated. We
suspect that the small number of patients who were treated
without ligation of the SFJ (13) versus the 93 patients who
did have SFJ ligation produced falsely positive statistical significance. We question if inflammation is the most likely cause
for small vessel networks since ligation should not increase or
decrease the extent or time of inflammation.
ClosureFAST
In 2006, VNUS introduced the ClosureFAST catheter. This new
device promised increased time efficiency and ablation of
incompetent veins of any size. The 7F ClosureFAST catheter
allows 7 cm segments of vein to be uniformly heated for
20 seconds at 120°C. The temperature is maintained by a
radiofrequency generator through a feedback loop, and vein
segments are treated serially
needed.
42
While treatment with the Closure system was limited
to veins of less than 12 mm, no diameter restrictions are indicated with the ClosureFAST catheter.
recommends the initial and most proximal 7 cm of great
saphenous vein to be treated with two consecutive cycles,
while the remaining vein segments may be treated with a
single cycle. Each disposable catheter is US$795 (as of
11/2009). Proebstle et al
FAST and either adjuvant ambulatory plebectomy (in 71.6%)
or foam sclerotherapy (in 13.9%). Mean treatment time
(spanning the time between catheter insertion and removal)
was 16.4 ± 8.2 minutes and 6.7 ± 1.7 treatment cycles. The
linear endovenous energy density was 116.2 ±
the initial 7 cm of GSV, and 68.2 ± 17.5 J/cm for the subsequent 7 cm. Patients were followed at 3 days, 3 weeks, 3
months, and 6 months post procedure. All patients had successful occlusion of their GSV. Via life-table analysis, occlusion rates were 99.6%. Seventy percent of patients experienced
no postprocedural pain. No deep vein thrombosis or skin
burns were seen. Side effects were infrequent with 3.2% paresthesias, 0.8% phlebitis, 1.6% hematomas, 2% hyperpigmentation, and ecchymoses in 6.4%. Mean patient down time
was 1.0 ± 1.9 days. Finally, 99% of treated patients would
recommend the ClosureFAST system to their friends.
Calcagno et al
43
investigated the relationship of size to
efficacy in 338 great and small saphenous veins following
ClosureFAST treatment. Initial occlusion rates, evaluated
between postoperative days 2 to 5, were not significant (94%
in veins ≤
12 mm and 96% in those > 12 mm). At 6 months,
complete occlusion rates in veins ≤ 12 mm or > 12 mm were
similar (98% and 100%, respectively). Interestingly, veins partially occluded in the immediate postoperative period developed complete occlusion at 6 months follow-up. Diameter
did not affect the outcome for successful treatment of incompetent saphenous veins with ClosureFAST.
41
with continuous pullback not
41,42
The manufacturer
41
treated, 252 GSVs with Closure-
11.6 J/cm for
The Recovery Study by Almeida et al,44 compared 87 GSVs
treated with either ClosureFAST or 980-nm diode endovenous
laser. This small, short term follow-up study of only 1 month,
demonstrated increased incidence of eccyhmoses, pain, phlebitis, and tenderness in the 980-nm laser group during the
initial postoperative 2 weeks. These increased side effects were
attributed to microperforations caused by the 980-nm diode.
While quality of life and venous severity scores were more
favorable in the initial 2 weeks in the ClosureFAST group, no
difference was seen at 1 month follow-up. No comparisons of
efficacy were provided in this short-term study.
Long-term studies are necessary to assess prolonged efficacy
of the ClosureFAST system. Radiofrequency and 1320-nm
Nd:YAG laser both stimulate collagen contraction, have negligible development of thrombi, and show decreased incidence of side effects, owing to lack of perforations of the vein
45
wall.
We feel a randomized, blinded trial comparing the
efficacy and safety of these two technologies is justified.
Technique for closure with ambulatory
phlebectomy
Once an incompetent GSV is diagnosed, the patient stands
and the locations of all varicose veins are highlighted with a
marking pen. This procedure is not recommend for the small
saphenous vein (SSV). The patient then lies down and the
exact location and depth of the GSV is confirmed with a
duplex scan with the patient lying on the examining table in
the operative position. All varicose veins are transilluminated
and marked with another marking pen color.
The leg is then prepped with Technicare solution, and
sterile drapes are placed allowing exposure of the varicose
veins including the SFJ and medial thigh. The table is placed
in a 30-degree Trendelenburg position. Tumescent anesthesia
is then given as previously described through a 21-gauge
spinal needle. Intravenous midazolam (2–3 mg) is sometimes
given through a hep-lock to alleviate patient apprehension.
Tumescent anesthesia is given along the entire course of
the varicose veins as well as around the GSV, both above the
facial sheath and circumferentially around the GSV within
its facial sheath. Typically 750–1000 mL of lidocaine 0.1%
with 1 : 1,000,000 epinephrine (adrenaline) is used, averaging
between 5 and 10 mg/kg of lidocaine.
A 2- to 3-mm incision is then made with a 11 blade medial
to the GSV in the mid to distal thigh, typically 20 to 40 cm
distal to the SFJ. A No.3 Muller hook is used to grasp the GSV
and bring it through the incision. This ‘blind’ retrieval of the
GSV is usually accomplished in less than 1 minute. Hemostats
are placed across the exposed GSV and it is ligated. The proximal portion is then opened with two toothed hemostats. The
Closure catheter is then placed into the vein and its tip positioned to within 1 to 2 cm of the SFJ. Correct tip placement
is confirmed by measuring the length of the catheter and with
duplex ultrasound. A slow heparin or saline drip is then
started and the catheter withdrawn slowly, maintaining
venous wall temperature at 90°C.
After the entire proximal GSV is treated, the distal stump is
ligated with a 3/0 Vicryl suture (Ethicon Inc, Somerville, N.J.).
The distal GSV and varicose veins are then removed through
a series of 2-mm incisions with a standard ambulatory phlebectomy technique.
At the conclusion of the surgery, the entire leg is wrapped
in a short stretch compression bandage over copious padding
over the incision sites from the varicose veins removed through
phlebectomy. No incisions are closed at all. The open 2-mm
incisions allow for drainage of the anesthetic solution over 24
hours, minimizing bruising. The patient is seen the next day
and the compression bandage is removed. The leg is checked
for hematoma or other adverse sequelae. All incisions are
covered with antibacterial ointment and a band-aid, and a
30- to 40-mmHg graduated stocking is applied. The stocking
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is left on 24 hours a day for 1 week. Patients may note some
bruising over the veins removed with phlebectomy. Anesthesia of the treated portion of the leg may persist for 8 to 24
hours. The patient is followed-up with a duplex ultrasound
study at 6 weeks. At that time, any open segments can be
treated by duplex-guided sclerotherapy. It has been our experience that when closed at 6 weeks, the GSV will remain closed,
fibrosed, and almost indistinguishable from surrounding
tissue at 6 months in all cases. Symptom reduction is rapid,
with many patients experiencing relief at 3 days but some not
until 6 weeks. Clinical improvement in appearance of varicosities is typically seen within 6 weeks as well.
Endoluminal Laser
With only a slight delay following the development of RF
endovenous ablation, lasers were applied to this application.
Various lasers have been demonstrated to effectively close
axial veins through thermal damage to endothelium with subsequent thrombosis and resorption of the damaged vein.
Endoluminal laser closure has lower disposable costs since
fiber optics are less expensive than more complex and more
engineered RF fibers. Prior to the development of ClosureFAST, lasers were much quicker to perform, with the speed of
pullback typically 10 to 20 cm/minute for 810–980-nm lasers
and 6 cm/minute for the 1320-nm laser. By increasing the
energy of the 1320 nm laser from 6 W to 10–12 W, the pullback rate can be increased to 2 mm/second, which doubles
the speed of this endoluminal laser. Studies comparing the
safety and efficacy of the higher energy/faster pullback
1320 nm laser are presently underway at the time of writing
this chapter (11/2009). Endovenous laser treatment (EVLT)
allows delivery of laser energy directly into the blood vessel
lumen in order to produce endothelial and vein wall damage
with subsequent fibrosis (Fig. 11.2). It is presumed that destruc-
tion of the GSV with laser is a function of thermal damage to
the endothelium and/or vessel wall. The presumed target for
lasers with wavelengths of 810, 940, 980, and 1064 nm is
intravascular red blood cell absorption of laser energy.
Immediate
Steam bubbles
Parietal burn
Fiberoptic
Delayed
Figure 11.2 Effects of endovenous laser treatment on the venous wall.
Application of laser energy in the varicose vein is responsible for various
types of venous wall lesions: due to direct absorption (according to
wavelength); due to fiber tip heating caused by carbonization; and due to
production of steam bubbles (there is always enough H
even if exsanguination has been realized). They result in a nonspecific
inflammatory process (partial internal layers destruction, venous wall edema,
followed by late sclerosis) accompanied by specific lesions: holes (maybe
related to pulsed mode) and thrombosis.
Venous wall
edema
Thrombosis
Endothelial lesion
Hole
O to evaporate,
2
However, thermal damage with resorption of the GSV has also
been seen in veins believed to be emptied of blood, although
it is virtually impossible to completely eliminate hemoglobin
as a chromophore by maneuvers such as leg elevation. While
direct thermal effects on the vein wall probably occur, absorption by blood usually plays a role.
Some authors advocate emptying the vein of blood via
manual compression, leg elevation, and tumescent anesthesia,
immediately before the procedure.
46,47
The presence of blood
has several drawbacks including: decreased transmission of
laser energy to the vein wall, potential of complete laser energy
absorption by blood resulting in thrombosis and recanalization, and melting of the laser tip via carbonization. However,
the presence of blood leads to steam bubble production,
which may contribute as a secondary mechanism to EVLT
efficacy.
46,48
The extent of thermal injury to tissue is strongly dependent
on the amount and duration of heat to which the tissue is
exposed. Linear endovenous energy density (LEED) is defined
as the total joules delivered divided by total centimeters of
treated vein. While some authors recommend a LEED above
70 J/cm to reduce the incidence of recanalization and recur-
49
rence,
others have shown no statistical difference in failure
rates based on LEED.
50
In addition, since each laser wavelength has a unique effect on the endothelial cells, water
content of the blood and/or red blood cells, the total energy
of one laser wavelength may not have the same efficacy as
another wavelength and cannot be casually compared. Moritz
and Henriques
51
investigated the time–temperature response
for tissue exposed to up to 70°C. They found that skin can
withstand temperature rises for very short exposure times and
that the response appears to be logarithmic as the exposure
times become shorter. For example, an increase in body temperature to 58°C will produce cell destruction if the exposure
is longer than 10 seconds. Tissues, however, can withstand
temperatures up to 70°C if the duration of exposure is less
than 1 second. Thus, any tissue injury from brief exposure to
temperatures less than 50°C would be expected to be
reversible.
One in vitro study model has predicted that thermal gas
production by laser heating of blood in a 6-mm tube results
in 6 mm of thermal damage.
26,52
These authors used 810-,
940-, and 980-nm diode lasers with multiple 15-J, 1-second
pulses to treat the GSV. A median of 80 pulses (range, 22–116)
were applied along the treated vein every 5 to 7 mm. Histologic examination of excised veins demonstrated thermal
damage along the entire treated vein with evidence of perforations at the point of laser application described as ‘explosivelike’ photo-disruption of the vein wall. This produced the
homogeneous thrombotic occlusion of the vessel. This effect
occurred only with blood-filled veins, not with saline-filled
veins, attesting to the absorption of laser energy by hemoglobin (Hb) and HbO
at these wavelengths. Since a 940-nm
2
laser beam can only penetrate 0.3 mm in blood,53 the formation of steam bubbles may contribute to the mechanism of
action. Multiple in vitro and animal models were performed
to delineate the mechanism of action for vein closure. A consecutive series of events occur in endovenous ablation:
1. laser energy absorption by blood
2. coagulum formation at the fiber tip
3. steam bubble formation and integration into the
coagulum
4. carbonization of the laser tip.
Carbonization seen histologically on the vein wall indicates a direct contact with the laser fiber. This interaction leads
to fibrosis and is believed by some to be the primary mechanism of vein wall closure. Thrombus formation results from
steam bubble production at the laser tip
48,54
and is thought to
contribute to vein closure. However, the volume of steam
Endoluminal Laser
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11
Intravascular Approaches to the Treatment of Varicose Veins: Radiofrequency and Lasers
306
produced in EVLT is not enough to result in signi ficant collagen damage. Of note in the experiments of Disselhoff et al
48
is that continuous mode resulted in more carbonization,
steam bubble formation, and higher and more persistent
endovenous temperatures than was found with an intermittent (pulsed) mode. Interestingly, in a study by Der Kinderen
55
no histological differences were seen between veins treated
with continuous or intermittent modes.
Another possibility for the mechanism of action of EVLT is
similar to that of RF closure – collagen contraction. Collagen
has been noted to contract at about 50°C, while necrosis
occurs at between 70°C and 100°C.
56
Whether collagen contraction, thermal damage, or a combination of the two effects
is responsible for destruction and resorption of the GSV is
unknown and remains controversial.
A metanalysis by Van den Bos and colleagues
57
compared
occlusion rates following EVLT (all wavelengths included), RF
ablation, ultrasound guide foam sclerotherapy (UGFS), and
high ligation with stripping from 64 studies and 12,320 limbs.
At 3 years, success rates were 94.5% for laser ablation, 84.2%
for RF, 77.4% for UGFS, and 77.8% for high ligation with
stripping. After 5 years, treatment success was seen in 95.4%,
79.9%, 73.5%, and 75.7% for laser ablation, RF ablation,
UGFS, and high ligation and stripping, respectively. The
authors found efficacy for high ligation and stripping, RF ablation, and UGFS were equal, but EVLT was more effective than
the other three regimens. The incidence of deep venous thromboses were less than 1% in both the radiofrequency and laser
ablation and less than 2% in conventional surgery. Risk factors
for the development of deep venous thrombosis post EVLT
include: general or epidural anesthesia, presence of coagulation disorder, or incorrect placement of the laser fiber tip.
58
810-nm Diode laser
Initial reports have shown this technique with an 810-nm
diode laser to have excellent short-term efficacy in the treatment of the incompetent GSV, with 96% or higher occlusion
at 9 months and less than a 2% incidence of transient
paresthesia.
to100%.
of postoperative ecchymosis and discomfort, major side effects
are rare. The lack of significant heating of perivenous tissues
probably explains the low complication rate found and argues
well for the continued lack of significant complications.
Our patients treated with EVLT with an 810-nm diode
laser have shown an increase in post-treatment purpura and
tenderness versus RF. Most of our patients do not return to
complete functional normality for 2 to 3 days, as opposed to
the 1 day ‘down-time’ with RF Closure of the GSV. Since the
anesthetic and access techniques for the two procedures are
identical, we believe that nonspecific perivascular thermal
damage is the probable cause for this increased tenderness.
In addition, recent studies suggest that pulsed 810-nm diode
laser treatment with its increased risk for perforation of the
vein, as opposed to continuous treatment which does not
have intermittent vein perforations, may be responsible for
the increase in symptoms with EVLT versus RF treatment
(Fig. 11.3).
As mentioned above, deep venous thromboses occur in less
than 1% of patients following endovenous laser ablation.
Kabnick
induced thrombosus (EHIT) at the superficial-deep venous
junction’ as follows:
Class 1 – thrombus in close proximity to the junction.
Class 2 – thrombus extending past the junction occluding
less than 50% of the vein.
Class 3 – thrombus extending past the junction occluding
more than 50% of the vein.
Class 4 – completely occluded deep venous thrombosis.
59–65
Two year success rates ranged from 93%
49,63,65
Although most patients experience some degree
66
classified the development of ‘endovenous heat-
57
Figure 11.3 Vein perforation with an 810-nm diode intravascular laser.
Isolated cases of pulmonary emboli have been reported
in 810-nm, 940-nm, 980-nm, and 1320-nm endovenous
58,63,66–70
lasers.
quently.
arteriovenous fistulas,
inflammation and neovascularization.
Seromas and hematomas occur infre-
68,71,72
Other rare events include the development of
73
which can form from thromboses via
74
The area most at risk
for arteriovenous fistula development is the popliteal fossa, as
the SSV lies in close proximity to the superficial sural artery.
Tumescent anesthesia was not utilized in this patient. The
authors proposed the use of tumescent anesthesia to aid
in the separation of the veins from nearby arteries with a
resultant decreased incidence of arteriovenous fistulas.
thromboplebitis from Staphlococcus aureus has been described
after EVLT; in that case, the patient made a full recovery following extensive debridement and intravenous antibiotics.
Retained guidewires have been described post EVLT, resulting
in dyspnea and chest pain. Guidewires more than twice the
length of the sheath are recommended to decrease the chance
of this complication. Finally, an endovenous catheter sheath
fragment was found in a patient’s heart septum, resulting in
arrythmias.
58
If the laser fiber tip fails to project outside of the
protective sheath that is used to guide the optical fiber, the
fiber can melt the plastic sheath and release a fragment into
the systemic circulation with devastating consequences.
Continuous pullback speed of a fiberoptic is faster than
electrode-based RF Closure pullback and may be simplified by
the technique described by Guex
77
using a cutaneous centimetric scale and an external electronic metronome when it is not
included in the laser generator software. Power and speed are
easily calculated from Table 11.1.
26,78,79
Corcos79 has developed
a manual technique of pulling the fiber back and forth within
the vein in an attempt to limit vein wall perforation. Even with
his expert technique in judging by feel when the vein has been
sufficiently damaged to stop the back and forth movement, he
still has found perforation in 2 of 24 treated veins and fullthickness injury in 22 of 24 veins. In our experience, trying to
vary the fluence and treating with a continuous laser pullback
versus pulsed pullback has not resulted in an elimination of
vein perforation.
56
Although most studies report 1 to 2 years of follow-up, we
have been seeing patients back in follow-up now 4 years after
the procedure with recurrent or new GSV. Sadick et al
reported a 4-year follow-up evaluation of 94 limbs treated
with the 810-nm diode laser (continuous mode, 14 W,
1–2 mm/second pullback) combined with ambulatory phlebectomy. The overall recurrence rates was 4.3%, with the
majority of recurrences within the first 6 months. Our impression is that our patients undergoing 810-nm diode laser
treatment with continuous pullback at 12 W, including ambulatory phlebectomy of distal veins, have a far higher recurrence
rate than those treated with RF Closure at similar follow-up
times. Our estimate is a 20% recurrence rate with 810-nm
diode laser versus a 10% recurrence rate with RF Closure.
73
Septic
58,76
58
75
80
Table 11.1 Examples of pullback speeds according to mode, applied power, and desired energy
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Generator Setting
Pulsed Mode 12 W,
Desired Energy
48–50 J/cm 4 impacts/cm
60 J/cm 5 impacts/cm
Adapted from Guex J-J: Phlebologie 57:209, 2004.
1 s, Pause 1 s
or 8 s/cm
or 7.5 cm/min
or 10 s/cm
or 6 cm/min
Pulsed Mode 15 W,
1 s, Pause 1 s
3 impacts/cm
or 6 s/cm
or 10 cm/min
4 impacts/cm
or 8 s/cm
or 7.5 cm/min
940-nm Diode laser
A longer wavelength such as 940-nm has been hypothesized
to penetrate deeper into the vein wall with resulting increased
efficacy. This is a false assumption since penetration is not due
to length of the wave in nanometers but is a result the intensity of absorption by water and can be predicted based on
water absorption data. A report of 280 patients with 350
treated limbs with 18-month follow-up demonstrated complete closure in 96%.
81
Twenty vein segments were examined
histologically. When veins were treated with 1 second duration pulses at 12 J, perforations were not present. When the
fluence was increased to 15 J with 1.2- and 1.3-second pulses,
microperforations did occur but were said to be self-sealing.
The author suggests that his use of tumescent anesthesia as
well as the above-mentioned laser parameters are responsible
for the lack of significant perforations and enhanced
efficacy.
An additional study of 109 treated GSV followed for 12
months with duplex scanning demonstrated a 10% recurrence
24
rate.
Another 5% exhibited incomplete proximal recanalization over 12 months. A 3 to 12 month evaluation of 33
patients who had an incompetent small saphenous vein
showed no recanalization.
nonoccluded/closed veins suggested that low laser fluences
were the primary reason for recanalization.
82
An analysis of the 10% of
83
Proebstle et al84
investigated the 940-nm diode laser (continuous mode) at
two settings – 15 W (5 mm/second pullback) and 30 W
(3–4 mm/second) – in 263 great saphenous veins. At 12
months, occlusion rates were 82.7% and 97% in the 15 W and
30 W groups, respectively. No difference in side effects was
found between the two cohorts.
980-nm Diode laser
A 980-nm laser has also been used to treat/close the
68,85–87
GSV.
in the 20 and 15 patients with 1- and 3-month follow-up,
respectively. The authors experience with the 980-nm laser is
similar to their experience with the 810- and 940-nm lasers.
They speculate that the 980-nm wavelength would allow
increased penetration into the vein wall with better results.
However, no major differences between 810-, 940- and
980-nm lasers were found in an in vitro study.
A comparison study in 60 limbs randomized to receive
either 810-nm or 980-nm endoluminal laser treatment of the
GSV revealed minimal differences between the two lasers
immediately after the procedure and at 12-months follow-up.
A short-term success rate of 97% was shown in a multicenter
study of 1703 limbs treated with the 980-nm diode laser.
97.1% 4-year occlusion rate was reported in 511 GSVs (continuous mode, pullback 3 mm/second, 10 W).
Complete closure without adverse effects was seen
52
88
68
A
87
Continuous
Mode 12 W
4 s/cm
or 15 cm/min
5 s/cm
or 12 cm/min
Continuous
Mode 15 W
3 s/cm
or 20 cm/min
4 s/cm
or 15 cm/min
1064-nm Nd:YAG laser
Three published studies have evaluated a 1064-nm Nd:YAG
endoluminal laser.
goat vein was used. Occlusion was more likely when fluence
exceeded 84 J/cm2. More importantly, treated vessels were not
perforated even with a fluence of 224 J/cm2. A diffusing fiber
was also used to obtain circumferential damage.
The paper by Chang and Chua
using an endoluminal 1064-nm Nd:YAG laser in the treatment of incompetent GSVs in 151 men and women with 252
treated limbs. Unfortunately, the surgeons also ligated the SFJ,
which did not allow for a determination of the efficacy of SFJ
ablation. Spinal anesthesia was used. Laser power was set at
10 or 15 W, delivered with a pulse duration of 10 seconds,
with manual retraction of the laser fiber at a rate of 10 seconds/
cm. Skin overlying the treated vein was cooled with cold
water. Unfortunately, this treatment resulted in superficial
burns in 4.8% of patients, paresthesia in 36.5%, superficial
phlebitis in 1.6%, and localized hematomas in 0.8%. This
wavelength has not gained wide acceptance due to the high
complication rate. This can be predicted by relatively poor
absorption by water leading to greater penetration and nonspecific heating.
89–91
In one study,89 the lateral saphenous
90
reported a clinical study
1320-nm Nd:YAG laser
In an attempt to heat vein walls more directly by heating water
in the vein walls (and to reduce the risks of superheating of
hemoglobin and subsequent thrombus formation), Goldman
and Weiss helped to develop a 1320-nm endoluminal laser.
At this wavelength, tissue water is the target and the presence
or absence of red blood cells within the vessels has relatively
little effect. An important element was the inclusion of a
mechanical catheter drawback system and a radial delivery of
energy to provide more uniform and predictable heating of
the vessel. Studies in porcine GSV demonstrated full-thickness
thermal damage at 5 W with the 1320-nm laser and at 20 W
with the 1064-nm laser.91 In a mathematical model comparing the 1320-nm and 980-nm lasers, the 1320-nm laser had
increased venous wall absorption and produced vein wall
damage at a lower energy.
Clinical studies have demonstrated close to 100% efficacy
without evidence of vessel perforation with use of the 1320-nm
Nd:YAG intravascular laser in 24 patients with 6- to 12-month
follow-up (Fig. 11.4).
in 64 patients at 5 to 6 W with pullback of 1 mm/second.
Follow-up extended up to 5 years, with a mean follow-up of
25.3 months. A 7.8% failure rate was found.
as well as postoperative adverse sequelae were identical to
those seen with VNUS Closure treatment (Fig. 11.5).
92
93
We investigated the 1320-nm laser
94
Clinical results
Endoluminal Laser
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Intravascular Approaches to the Treatment of Varicose Veins: Radiofrequency and Lasers
Weiss et al95 have compared 36 GSVs treated with the
810-nm diode laser to 42 GSVs treated with the 1320-nm
Nd:YAG laser and 174 GSVs treated with RF closure. They
found a 95% success rate with both RF and 1320-nm endoluminal treatment, without adverse effects. In contrast, the
810-nm diode laser achieved an 86% success rate, with 52%
of patients experiencing significant pain interfering with
walking for 2 to 3 days and 99% with significant bruising
covering 75% or greater of the treated area. Proebstle et al
96
evaluated 282 limbs treated with 1320-nm Nd:YAG (continuous mode, pullback 1 mm/second, 8 W), 940-nm diode
(continuous mode, pullback 4–5 mm/second, 15 W), and
940-nm diode (continuous mode, pullback 3 mm/second,
30 W). Success rates at 3 months were 97%, 90.3%, and 100%,
respectively. No statistical differences in phlebitis or paresthesias were noted between the three groups, but the 1320-nm
Figure 11.4 Full-thickness thermal damage affecting endothelium, smooth
muscle, and adventitia 1.3–1.5 mm after endoluminal laser treatment with a
1320-nm laser at 5 W, with continuous pullback at a rate of 1 mm/s.
group had significantly less pain. The 1320-nm laser resulted
in lower incidences of ecchymoses than the 940-nm at 30 W.
1470-nm Diode laser
With the concept of targeting water without targeting hemoglobin, additional wavelengths targeting tissue water are in the
process of being introduced for endovenous ablation. Successful implementation of the 1320-nm laser by us resulted in
decreased adverse events and high efficacy rates, and so it was
predictable that other available wavelengths that avoid hemoglobin but heat water would be tried. Most recently a 1470-nm
diode laser was tested, as this wavelength has a high affinity
for water. Since this wavelength is rapidly absorbed by the
water content of blood and utilizes a fiber tip with a spacer
instead of the traditional bare tip fiber, there is a significant
compression of the vein is required along with copious tumescent anesthesia for fiber and vein wall contact.
Pannier,
98
117 limbs were treated with the 1470-nm diode
97
In a study by
(continuous mode, 15 W) and a LEED of either greater than
or less than 100 J/cm. Both groups maintained 100% occlusion at 1-year follow-up. All patients were prophylactically
treated with 7 days of low molecular weight heparin. No deep
vein thrombosis or pulmonary emboli occurred. Paresthesias
arose in 9.3%, with an increased incidence noted in the
patients treated with a LEED of over 100 J/cm. As the two
groups displayed similar efficacy, the authors recommend an
LEED of less than 100 J/cm be utilized to decrease the risk of
side effects. One hundred and six GSVs were randomized to
receive either 1470-nm or 980-nm, both at 15 W with adjuvant ambulatory phlebectomy. Significantly less pain, ecchymoses, induration, transient paresthesias, and time to return
to daily activities were seen in the 1470-nm laser cohort.
1500-nm Diode laser
The 1500-nm diode laser is another recent advancement in
endovenous laser ablation technology. Similar to the 1470-nm
diode laser, the 1500-nm diode targets water in the vein wall.
Compared to the 980-nm laser, the 1500-nm laser showed
more uniform destruction of the vein wall in an animal
100
model.
Vuylsteke et al
diode laser (6 W above the knee and 5 W below the knee,
101
treated 158 GSVs with a 1500-nm
99
A
Figure 11.5 A, Before and, B, 1 week after 1320-nm Nd:YAG laser treatment with ambulatory phlebectomy. Note no bruising over the proximal great
saphenous vein, only over the veins treated with ambulatory phlebectomy.
308
B
using continuous mode and a pullback rate of 1 mm/second).
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The average LEED was 53.4%. An occlusion rate of 93.3% was
found at 6 months follow-up. Ecchymosis was mild in 31.6%
of patients, moderate to severe in 19%, and undetectable in
49.4% of patients. Moderate pain was detected in 1% of
patients and no paresthesias were encountered. The authors
suspect the decreased incidence of the adverse events was due
to lack of perforation in the vein wall. A further comparison
was made with their previous study investigating the 980-nm
diode (10 W) laser occlusion and adverse event rates. Though
the efficacy rates were equivalent, side effects such as ecchymoses, induration, discomfort, and paresthesias were statistically less with the 1500-nm diode.
Endovenous laser treatment of the small
saphenous vein
Varicose veins are associated with an incompetent SSV in onefifth of patients. The SSV course lies in close proximity to the
sural nerve. As a result, increased incidences of paresthesias
have been noted following EVLT of the SSV. Endovenous laser
ablation using the 980-nm diode (accessed by micropuncture
technique, continuous mode, 10–14 W, pullback 3–5 mm/
second) for SSV was investigated by Gibson et al. Ninety-four
percent of patients had at least one adjuvant treatment at the
time of endovenous laser ablation: foam sclerotherapy, microphlebectomy, ligation of perforators, or EVLT of the GSV. Of
the 210 small saphenous veins treated via tumescent anesthesia, 100% were occluded at 1 week. Three months posttreatment, 96% of SSV remained occluded. Nonocclusive deep
venous thromboses extending into the popliteal vein were
found in 5.7% of patients at 1 week postoperative. Numbness
developed in 1.6%.
A study by Park et al
(assessed percutaneously, pulsed mode, 12–15 W, 2 mm/
second pullback) in treating 390 incompetent SSVs. All
patients were treated using 70 to 220 mL of tumescent
anesthesia. One-third of patients had concomitant EVLT of
their GSV. High closure rates of the SSV were reported: 99.7%
at 1 week postoperative and 99.4% at 1 year. The majority of
patients experienced ecchymoses and skin tightness, which
resolved in 2 weeks. Other side effects were infrequent: 2.3%
phlebitis and 2% paresthesias. No skin burns or deep vein
thrombosis developed.
The 810-nm diode laser treated 41 SSVs (continuous mode,
8–10 W, pullback 2–3 mm/second) and 135 GSVs (continuous mode, 12–14 W, pullback 1.5–2 mm/second) under
tumescent anesthesia in a paper by Jung et al.
anesthesia was added if phlebectomy was simultaneously performed. Recanalization was found in 7.3% of the 41 SSVs at
the 3 month postoperative follow-up. One case of foot drop
was reported following endovenous laser ablation of the SSV
and ambulatory phlebectomy. Following surgery, intramuscular hemorrhage resulted in muscular edema and pressure on
compression of the peroneal nerve. The patient recovered following 2 months of physical therapy.
102
103
explored the 980-nm diode laser
104
Spinal
recurred in those treated with the 980-nm diode laser with
compression. No infections arose in either cohort. In the
paper by Fernandez et al,
106
102 (6.54%) of their patients
possessed preoperative ulcers. All ulceration showed healing
in a mean of 5.2 weeks post 810-nm diode endovenous laser
ablation; however, three cases experienced reopening of their
ulcerations.
Technique for endoluminal laser ablation
using a standard sharp fiberoptic
Varicose veins are marked with the patient standing and again
with the patient lying down in the operative position with
a Venoscope, as previously described.
marking, the area surrounding the GSV and distal tributaries
to be treated is infiltrated with lidocaine 0.1% tumescent
anesthesia. The amount of tumescent fluid averages 800 mL
with a lidocaine dose of approximately 8 mg/kg. An alternative is semitumescent anesthesia with a cocktail of 20 mL
lidocaine with epinephrine + 20 mL normal saline + 10 mL
sodium bicarbonate, injected in the saphenous fascia under
ultrasound guidance (Fig. 11.6). The GSV is then accessed
either under duplex guidance according to Seldinger technique at any level, or through a 2- to 3-mm incision (Fig. 11.7).
A 500 to 600-µm laser fiber is inserted into the vein within
a protective sheath so that only the distal 2 to 3 mm of laser
fiber exits from the sheath (Fig. 11.8). A helium–neon (He:Ne)
aiming beam that is continuously illuminated when the laser
is on insures that the laser fiber is outside of the sheath. If the
laser fiber retracts within the sheath, thermal destruction of
the sheath occurs.
Correct placement of the laser fiber tip 2 cm distal to
the SFJ (Fig. 11.9) is confirmed through catheter length
A
29,30
After appropriate
Endoluminal Laser
Endovenous laser therapy for stasis ulcers
Viarengo et al
postoperative compression versus compression alone in the
treatment of stasis ulcers. Compression consisted of elastic
support hose, elastic bandages, or Unna boots. All 52 patients
suffered from ulceration for over 1 year prior to study enrollment. After 3 months of treatment, ulcerations had improved
in 62.9% of the EVLT with compression compared to 12% in
the compression group. At 12-months follow-up, ulceration
healing was 81.5% and 24% in the EVLT with compression
and compression alone groups, respectively. A 44.4% recurrence rate was noted with compression alone. No ulcerations
105
investigated the 980-nm diode laser with
B
Figure 11.6 Points of injection for ultrasound-guided semi-tumescent local
anesthesia.
309
Chapter
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11
measurement, duplex examination, and viewing the He:Ne
aiming beam through the skin (Fig. 11.10). The laser is in a
continuous firing mode at a manufacturer recommended
energy setting, which is wavelength dependent, with either
slow mechanical withdrawal at a rate to approximate 1 mm/
second or, in the case of the 1320-nm system, a continuous
J Guide Wire
pullback mechanism set for 1 mm/second (Fig. 11.11). This
technique minimizes pain and maintains efficacy of treatment. The treated leg is then wrapped in gauze to absorb the
tumescent fluid with an overlying compression bandage. The
patient returns the next day, when the bandage is changed to
a 30- to 40-mmHg graduated compression stocking. The compression stocking is then worn for 7 days continuously and
then while the patient is ambulatory for another 7 days.
Patients are evaluated at 1 day, 7 days, and 3 weeks postoperatively to determine treatment efficacy. Some authors
propose retreating the patient if there is recurrent reflux in
the GSV. We have not found this to be necessary in our
patients as most recanalizations can be treated by foam
sclerotherapy.
Figure 11.7 Introduction of J Guide Wire through phlebotomy when
echo-guided access is not possible.
Good: sheath retracted 2–3 cm
Intravascular Approaches to the Treatment of Varicose Veins: Radiofrequency and Lasers
Fiber tip
Wrong: will burn the sheath
Sheath
Figure 11.8 Fiberoptic/sheath relative positions to avoid burning of
sheath.
J Guide Wire
introducer
‘Mosquito’
forceps
Great
saphenous
vein
Conclusions
The techniques of energy application within the endoluminal
space using RF or laser has become the gold standard for treatment of saphenous reflux. Endovenous ablation has proven
itself over the last decade as a far less invasive alternative to
Tributary
Common
femoral vein
Great
saphenous vein
Femoral vein
Before
treatment
Figure 11.9 New therapeutic goals of endovenous treatments. Current
endovenous treatments do not require junctional suppression; conversely,
conservation of the junction provides drainage for tributaries (descending
tributaries from abdominal and groin skin), limiting the trend for recurrence.
Crossectomy
and stripping
Endovascular
A
Figure 11.10 A, Fiberoptic starting position, before applying laser energy and withdrawing, in the great saphenous vein. B, Catheter and fiber withdrawal
in pulsed mode.
310
Saphenous-femoral
junction
2 cm
Aiming beam
Great saphenous
vein
Femoral vein
Saphenous-femoral
junction
B
Digital compression
Withdraw
fiber and
sheath
Femoral
vein
References
https://t.me/med1917
A
Figure 11.11 Fixed rate pullback with the 1320-nm system of endovenous ablation.
ligation and stripping, as well as a faster and less expensive
method to treat varicose saphenous trunks and junctions.
Initial clinical experience in several thousand patients shows
a high degree of success with minimal side effects, most of
which can be prevented or minimized with minor modifications of the technique. In our experience, RF and the 1320-nm
laser provide the best results with the least adverse sequelae.
The advantages of 1320-nm endovenous treatment over RF is
its lower cost per patient and ability to treat more tortuous
veins with a more flexible fiber optic, as well as being faster
than the old electrode-based RF treatment. Performing ambulatory phlebectomy at the same time as endovenous ablation
is an available option which provides excellent long-term
results.
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