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460 Laser treatment of the incompetent saphenousvein
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BOX 38.5: Post-operative adverse events
●
Ecchymosis
●
Pain
●
Paresthesia
●
Infection
●
Cutaneous thermal injury
●
Superficial thrombophlebitis
●
Deep vein thrombosis
Adverse patient events that may occur are dysrhythmia or
vagal reaction (oen because of anxiety), saphenous or sural
nerve pain, or transient heat (the last two usually occur
because of inadequate anesthetic inltration).
Post-operative adverse events include bruising, pain,
paresthesia, infection, skin burn, supercial thrombophlebitis, lymphedema, and deep vein thrombosis (Box 38.5).
Anecdotal case reports of retained ber/sheath,
arteriovenous stulae,42 and death (personal communication) have been published.
Bruising is usually minimal, especially with the
higher-wavelength lasers16 and modified fibers,
of limited duration.
16,18
The incidence of paresthesia
is generally <1%,43 and unlike after GSV or SSV stripping, it has been our experience that paresthesia following endovenous ablation is usually mild, short-lived, and
limited to the distal thigh following GSV ablation and
the distal calf, ankle, and foot following SSV ablation.
Furthermore, it has been our observation that the rate
of paresthesia is inversely related to the practitioner’s
experience with perivenous ultrasound-guided anesthesia. Infection and skin burns are rarely reported and are
easily avoided with the perivenous anesthetic injected to
separate the skin from the underlying vein to be treated.
Superficial thrombophlebitis is generally reported in less
than 10% of cases43 and responds to the usual clinical
measures of anti-inflammatory medication, compression,
and ambulation. Lymphedema has not been reported, but
we have seen it in our own center, and it is believed to
be caused by unrecognized impaired lymphatic drainage
that is usually present prior to any procedures. Treatment
of this complication may include exercise, therapeutic
lymphatic massage, and compression with multilayered
short-stretch bandages, pneumatic compression devices,
and compression hose.
Deep vein thrombosis is perhaps the most signicant
complication, although the incidence reported in the laser
literature is quite low.44 Most true deep vein thromboses
develop in calf veins, and because they are considered to
be “provoked,” they are usually of limited clinical signicance. More proximal deep vein thromboses do occur, however, and should be aggressively searched for and treated.
Treatment is well explained elsewhere in this text. A thrombophilic condition should be considered in any patient who
develops deep vein thrombosis in the post-operative period,
40
stroke,41
30,35
and
15L8w-S
14.0 MHz
Superf. Ven
General/V
Thrombus extension
Laser fiber in GSV
CFV
Figure 38.5 Thrombus extending from the great saphe-
nous vein into the CFV. CFV: common femoral vein; Laser
fiber in GSV: thrombus extending from laser fiber tip within
the great saphenous vein with surrounding tumescent
anesthesia. (Courtesy of D. Neuhardt, Compudiagnostics.)
67 dB T1/+1/2/4
Gain = 10 dB Δ = 4
Store in progress
47 Hz
RT GSV
especially if it is accompanied by a previous episode, family
history, or history of multiple miscarriage.
A dierent thrombotic entity has been described by multiple authors as thrombus extensions from the saphenous
veins into the common femoral or popliteal vein, identied
early in the post-operative period by routine duplex followup examination. is complication has been described as
endothermal heat-induced thrombosis45 or post-ablation
supercial thrombus extensions,46 with categorization of
these thrombi for treatment algorithms. However, such
thrombus extensions (Figure 38.5) have rarely been associated with embolization, so it is unsettled as to how to
manage them. As rst reported by McMaster22 and in more
recent symposia discussions among venous experts, because
of the number of routine duplex examinations needed to
identify a clinically signicant venous thromboembolism,
these examinations being performed as a routine following
endovenous saphenous ablation may not be warranted.
Recanalization of the laser-ablated vein does occur and
may be identied at any time aer treatment. However,
patients remain asymptomatic for some time aer it is
detected on duplex ultrasound. Once recanalization occurs,
the vein rarely goes on to complete occlusion.
47
Recurrent varicose veins following laser ablation may be
considered a complication or a natural progression of the
disease process. is topic is covered later in the text and
therefore will not be discussed here. It should be mentioned
that depending upon the location of recurrence, endovenous
laser ablation is sometimes included in the treatment.
48
38.8 PERFORATOR VEIN LASER
ABLATION
Controversy remains as to the role of perforator vein
incompetence in the healing and subsequent recurrence rate of venous ulcers. Perforator laser ablation is
References 461
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technically feasible, and some investigators have concluded that thermal ablation of supercial and perforator
veins enhances healing and reduces the incidence of recur-
49,5 0
rence,
However, Marston51 and Samuel et al.52 have
reported that, with limited evidence to substantiate a positive eect on ulcer healing, recurrence, or quality of life
improvement, additional studies are required to dene the
role of perforator thermal ablation in C5 and C6 patients.
Furthermore, it has been well-documented that when perforator and truncal vein incompetence coexist, perforator
incompetence is oen eliminated by treatment of the truncal vein alone.
53
38.9 SUMMARY
Endovenous laser ablation is generally safe. Intra-operative
and post-operative complications are uncommon and
generally less frequently seen than with more traditional
surgical procedures. Dierences in methods of follow-up
examination and in denitions of successful ablation may
help explain the variance in results between published
reports and those seen in the surgeon’s own clinical setting. Randomized controlled trials comparing endovenous
laser ablation with other modalities (with long-term followup) have demonstrated, and will continue to demonstrate,
where these minimally invasive methods belong in the therapeutic armamentarium for the treatment of chronic venous
disorders of the lower extremity. Oce-based ablation techniques have been shown to be more cost eective than traditional operating room-based surgical treatment.54 While
some surgeons have previously expressed the view that none
of these techniques has yet been shown to be better than
conventional surgery in the long term, patient perceptions
have uniformly been that minimal invasion is better.
Finally, careful follow-up post-laser ablation should
result in more complete treatment of the patient’s venous
disorder, with better resolution of the patient’s symptom
complex. It is simply not appropriate to ablate only the proximal saphenous vein and expect long-lasting resolution of
the patient’s symptoms and varicosities. Unless one is committed to a program of meticulous follow-up and adjunctive
treatment, the practitioner and the patient will be le with
unsatisfactory results.
38.10 CONCLUSIONS
●
Endovenous laser ablation of the saphenous vein
eectively removes the target vein from the venous
circulation.
●
Endovenous laser ablation is safe and well tolerated, with
a low incidence of signicant complications reported.
●
Adjunctive therapy to permanently eliminate the
saphenous vein and all other sources of reux disease
is integral to the adequate control of supercial venous
insucienc y.
●
Careful follow-up will ensure the best results.
●
Long-term outcome reports are necessary to conclude
that endovenous laser ablation is a durably eective
method of treating supercial venous insuciency.
●
Randomized controlled trials comparing endovenous
laser ablation with other methods (including surgery,
RF ablation, and chemical ablation) have demonstrated
quality of life improvements equal to or better than
other endovenous ablation methods.
Guidelines 4.10.0 of the American Venous Forum on laser treatment of the incompetent saphenous vein
Grade of evidence (A: high
quality; B:moderate quality;
C:low or very low quality)
No. Guideline
4.10.1 Endovenous laser therapy of the great saphenous vein
is safe and effective and we recommend it for the
treatment of saphenous incompetence.
4.10.2 Clinical outcome after endovenous laser therapy up to
3 years is comparable to traditional stripping and
ligation and we recommend it for the treatment of
the incompetent great saphenous vein.
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★
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below-knee reflux? A randomized controlled trial.
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junction. Eur J Vasc Endovasc Surg 2011;41:685–90.
22. McMaster S. Is routine scan for DVT necessary following endovenous laser ablation and ultrasound-guided
sclerotherapy? A statistical perspective in Australian
phlebology practice. Phlebology 2011; 26:49 – 51.
◆
23. de Maeseneer M, Pichot O, Cavezzi A etal. Duplex
ultrasound investigation of the veins of the lower
limbs after treatment of varicose veins. UIP consensus
document. Eur J Vasc Endovasc Surg 2011;42:89–102.
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A new minimally invasive method of treatment for
varicose veins—Preliminary observations using an
810 nm diode laser. Dermatol Surg 20 01; 27:118 – 2 2 .
25. Proebstle T, Gul D, Kargl A, and Knop J. Endovenous
laser treatment of the lesser saphenous vein with
a 940-nm diode laser: early results. Dermatol Surg
2003;29:357–61.
26. Timperman P, Sichlau M, and Ryu R. Greater energy
delivery improves treatment success of endovenous
laser treatment of incompetent saphenous veins.
JVasc Interv Radiol 20 0 4;15:1061–3.
27. Vuylsteke M, Van den Bussche D, Audenaert EA etal.
Endovenous laser obliteration for the treatment of
primary varicose veins. Phlebology 2006;21:80–7.
28. Disselhoff B, der Kinderen D, and Moll F. Is there
recanalization of the great saphenous vein 2 years
after endovenous laser treatment? J Endovasc Ther
2005;12:731–8.
●
29. Myers KA and Jolley D. Outcome of endovenous
laser therapy for saphenous reflux and varicose veins:
Medium-term results assessed by ultrasound surveillance. Eur J Vasc Endovasc Surg 2009;37:239–45.
●
30. Marston W, Owens L, Davies S etal. Endovenous
saphenous ablation corrects the hemodynamic
abnormality in patients with CEAP clinical class 3–6
CVI due to superficial reflux. Vasc Endovasc Surg
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31. Rasmussen LH, Lawaetz M, Bjoern L etal.
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vein with clinical and duplex outcome after 5 years.
JVasc Surg 2013;58:421–6.
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ablation versus laser for varicose veins. Br J Surg
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Refinement of a new technique. Eur J Vasc Endovasc
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35. Theivacumar NS, Darwood RJ, and Gough MJ.
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accessory great saphenous vein (AAGSV): Abolition
of sapheno-femoral reflux with preservation of the
great saphenous Vein. Eur J Vasc Endovasc Surg
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37. Guzelmansur I, Oguzhurt L, Koca N etal.
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39
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Emerging endovenous technology for chronic
venous disease: Mechanical occlusion chemically
assisted ablation (MOCA), cyanoacrylate
embolization (CAE), and V block-assisted
sclerotherapy (VBAS)
STEVE ELIAS
39.1 Introduction 465
39.2 MOCA ablation 465
39.3 CAE (VenaSeal™) 468
39.4 V block-assisted sclerotherapy 470
39.1 INTRODUCTION
Endovenous ablative technologies continue to evolve,
with the development of mechanical occlusion chemically assisted (MOCA) ablation, cyanoacrylate embolization (CAE), and V block-assisted sclerotherapy (VBAS).
Currently, all endovenous technologies can be classied
under two general categories: thermal tumescent (TT) or
non-thermal non-tumescent (NTNT).
include radiofrequency, laser, and steam. NTNT technologies encompass MOCA ablation, CAE, VBAS, and polidocanol endovenous microfoam, with others emerging. e
NTNT segment is the fastest growing due to some inherent
advantages: minimal nerve or skin injury; safety when treating disease to the ankle; decreased patient discomfort due to
the decreased needle sticks by avoiding tumescence; and the
elimination of any capital equipment (generator). As with
the TT techniques, all NTNT approaches can be performed
in an oce setting in under an hour. Patients can return to
normal activity almost immediately (Table 39.1).
e above advantages of NTNT do not sacrice safety,
ecacy, or clinical outcomes when compared to TT techniques. All technologies have been shown to signicantly
improve quality of life (QoL) measures.
successful occlusion of an axial vein (great saphenous vein
1
e TT technologies
2,3
4,5
We know that
39.5 Discussion 471
39.6 Overall summary 471
References 473
[GSV], small saphenous vein [SSV], and anterior accessory
GSV, etc.) improves a patient’s QoL no matter what technology is used.6 In fact, the evidence is so compelling regarding QoL improvement that societal and government health
agencies have recommended that endovenous ablation be the
rst modality of choice for symptomatic axial vein incompetence.
it is about treating the patient. e idea of the occlusion rate
being the primary endpoint has faded in recent years. e
primary endpoint of “Did we improve patients’ QoL?” is
now at the forefront, as it should be. Physician-derived and
patient-reported outcome measures are now what academics and third-party payers consider to be primary endpoints.
We treat patients, not veins. With these concepts in mind,
we can better understand where the NTNT technologies of
MOCA ablation, CAE, and VBAS can be best utilized when
caring for patients with vein disease.
7,8
Successful ablation is not about treating the vein,
39.2 MOCA ABLATION
39. 2.1 O verv iew
MOCA ablation (ClariVein™) has the longest follow-up and
was the rst of the new NTNT technologies to be reported.
e device was developed by Michael Tal and John Marano
465
466 Emerging endovenous technology for chronic venous disease
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Table 39.1 Thermal tumescent and non-thermal non-
tumescent technologies
TT NTNT
• Radiofrequency
• Laser
• Steam
TT vs. NTNT
TT (10%–15%) NTNT (85%–90%)
• Bigger veins
• Longer follow-up
• Nerves/skin: concerns
• Patient comfort:
tumescence (learning
curve)
Note: TT: thermal tumescent; NTNT: non-thermal non-tumescent;
GSV: great saphenous vein; SSV: small saphenous vein.
• Mechanical occlusion
chemically assisted
• Cyanoacrylate
embolization
• V block-assisted
sclerotherapy
• Polidocanol endovenous
microfoam
• GSV/SSV/C6/belowknee GSV
• Shorter follow-up but
equal
• Nerves/skin: no issue
• Patient comfort: better
• Shorter learning curve?
Figure 39.2 Mechanical occlusion chemically assisted
ablation angled wire unsheathed.
consists of sclerotherapy. Each component—mechanical
and chemical—is essential for good results. Each component alone yields poor results. e sclerosant exits the catheter sheath about 2 cm from the tip of the rotating wire, is
pulled up the sha of the wire, and is released from the tip,
thus directly “injecting” sclerosant into the damaged vein
(Figure 39.1).9 First-in-man evaluations were performed in
February 2009.10 ere are two components to the device/
technique: (1) mechanical damage to the endothelium by
a rotating wire (Figures 39.2 and 39.3); and (2) chemical
installation of a detergent liquid sclerosant (sodium tetradecyl sulfate [STS] or polidocanol) simultaneously. e
mechanical disruption allows for penetration of the sclerosant so that medial damage and scarring can occur, which
leads to occlusion.11 e wire rotates at 3500 rpm and, in
addition to causing endothelium damage, it also causes vein
spasm so sclerosant is not being injected into a vein lled
with blood (Figures 39.4 and 39.5). e technique not only
Figure 39.3 Mechanical occlusion chemically assisted
ablation wire rotating.
Figure 39.1 Mechanical occlusion chemically assisted
ablation (ClariVein) device.
Figure 39.4 Mechanical occlusion chemically assisted
ablation mechanism of action.
Figure 39.5 Mechanical occlusion chemically assisted
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ablation wire rotating/sclerosant injection.
wall (Figure 39.5). is action allows for sub-endothelial
penetration of sclerosant to aid in media damage. One can
think of the rotating wire as a sprinkler releasing sclerosant
from the tip. In the original trial, all veins received 12 cc of
1.5% STS liquid. A pullback rate of 1.5 mm/second or 1 cm
every 7 seconds was used. is was chosen because of the
similarity to the existing laser pullback rates at that time.
e volume of sclerosant used was irrespective of the length
of the vein being treated. e occlusion rate was 96% at
1year with minimal complications: no deep vein thrombosis (DVT), nerve, or skin damage. Venous Clinical Severity
Score (VCSS) improved, as expected with an occluded GSV.
Greater than 2–year follow-up was reported by the same
12
group
with a 96% occlusion rate.
39.2.2 Technique
e technique has undergone some modications since the
original report as all new techniques or technologies do.
Here are the current recommendations:
1. Micropuncture access with ultrasound (US) guidance.
2. Placement of a 4-Fr or 5-Fr micropuncture sheath into
the vein.
3. No further wire or sheath exchanges required and no
tumescence required.
4. Passage of the angled catheter portion of the device up
the targeted vein.
5. Unsheathing of the wire and placement of the wire tip
2 cm from the saphenofemoral junction (SFJ) or just at
the fascial curve of the saphenopopliteal junction (SPJ).
6. Attachment of the motor unit and the syringe contain-
ing sclerosant.
7. Volume of sclerosant determined by diameter and
length treated (table available).
8. Begin rotation only, no injection for the rst centime-
ter of pullback to induce vein spasm (i.e., from a position 2 cm to 3 cm from the SFJ).
9. Aer 1 cm of rotation only, begin drip infusion; the
patient only feels vibration.
10. Maintain constant rate of pullback (1.5 mm/second)
with continuous drip infusion.
39.2 MOCA ablation 467
11. Reload syringe when needed.
12. Post-treatment, have the patient ex ankles to wash out
any sclerosant in the deep system.
13. Wrap legs as per your protocol. is author uses 4- and
6-inch Ace bandages from the mid-thigh.
14. Have patient ambulate; they may resume normal
activity on the next day.
39.2.3 Technical pearls
e pullback rate is much more important for success than
the sclerosant volume. When failures are analyzed, the
operator oen pulled too fast and did not allow enough
time for sucient vein damage. In the original study, all
veins received 12 cc of 1.5% STS regardless of the length
treated. No DVT occurred. Obviously, some veins received
slightly too much and some received slightly too little damage, yet a 96% occlusion rate was achieved with no DVT/
skin/nerve injury. e technique is forgiving of volume,
but not forgiving of pullback rate. It is better to pull “too
slow” and give “too much” sclerosant that the contrary.
e type of detergent sclerosant does not aect outcomes.
e Dutch have reported comparable results with polidocanol 2% and 1%.
Conrm placement of the wire prior to starting treatment
with US; US visualization is not routinely needed during the
pullback. If there is a larger segment of vein (>8–10 mm),
then the US probe is used to partially compress that section
in order to improve vein wall contact. Routine pressure may
lead to the rotating wire getting caught on the vein wall. If
this happens (in perhaps 5% of cases), a quick jerk of the
wire will free the catheter. is is akin to pulling a bandage
quickly o the skin. You will know the catheter is getting
caught when you hear the motor slow down and the patient
experiencing a pulling sensation. e wire cannot be broken
by pulling it.
If doing concomitant phlebectomy, this author recommends access and placement of the MOCA ablation device,
but no treatment until the phlebectomy segment is completed; then the vein is treated. is sequence minimizes the
potential dwell time of sclerosant in the deep system, thus
minimizing the risk of DVT. ere are no studies demonstrating this theoretical issue. e reported DVT rate worldwide is less than 0.5%.
When imaging post-treatment, it is important to not only
use US greyscale, but color-ow duplex as well. With MOCA
ablation, the vein is immediately occluded, but it takes 3–6
months longer to contract (Figure 39.6). erefore, any early
US with greyscale will show a dilated vein. is nding is
in contrast to TT ablation. e additional use of color-ow
duplex will document the absence of ow.
As with most other endovenous treatments, the post-procedure compression and activity instructions have become
less onerous. is author uses compression for 24 hours
post-MOCA ablation and then only 3 days of compression
when awake. Any and all activity is allowed the next day.
ese instructions apply when phlebectomy is not included.
13
14
468 Emerging endovenous technology for chronic venous disease
https://t.me/med1917
Figure 39.6 Ultrasound post-mechanical occlusion chemi-
cally assisted ablation at 6 months.
119 patients to MOCA or radiofrequency ablation. MOCA
ablation had lower intra-operative pain scores with equal
occlusion rates and QoL improvements compared to radiofrequency ablation.
39.2.5 Summary
MOCA ablation currently has the longest follow-up of any
NTNT technology. Studies support its use for the great
majority of incompetent supercial axial veins. All measures are as good if not better than comparative TT technologies. ere are unique advantages of the NTNT techniques
and of MOCA ablation specically. At the conclusion of this
chapter, a summary of the benets, indications, and contraindications of all of the TT and NTNT technologies will be
presented.
39.3 CAE (VENASEAL™)
39.2.4 Results
To date, 16 articles have been published regarding MOCA
ablation (ClariVein™) in the peer-reviewed literature and
60,000 procedures have been done worldwide. e results
are overwhelmingly coincident with occlusion rates of
greater than 90%, and improvements in QoL measures are
signicant.15 Some specic studies which address specic
topics will be discussed.
e longest follow-up has been by the author of the
original clinical trial12 at greater than 2 years. van Eekeren
etal. reported similar results at 1 year when using polidocanol instead of STS. In addition, all of the QoL measures
improved at 1 year.
One of the advantages of any NTNT technology is
safety and the lack of risk of nerve injury when treating any
below-knee segment of vein. Boersma et al.17 reported the
1-year results for MOCA ablation when treating the SSV.
No nerve injury occurred and the occlusion rate was 94%.
ese results are encouraging in that SSV treatment has the
concern of potential injury to three nerves: sural, tibial, and
peroneal. Many physicians have been loath to treat the SSV
due to nerve risk and DVT. is study did not experience
either issue.
In terms of the management of more advanced disease
states, C6 ulcer patients experience another advantage with
NTNT technologies. In C6 patients, if the a xial disease reux
is to the ankle, it is desirable to treat the entire pathologic
segment. Tumescence is hard to place in an area of ulceration and signicant lipodermatosclerosis. is author has
used retrograde cannulation of the GSV in these circumstances with good results. Moore etal.
the use of MOCA ablation in a C6 patient with SSV incompetence with good results. Finally, two studies compared
MOCA ablation to radiofrequency ablation. van Eekeren
19
et al.
concluded that MOCA ablation yielded less postoperative pain, faster recovery, and sooner return to work
than radiofrequency ablation. Bootun et al.20 randomized
16
18
have reported on
39.3.1 Overview
CAE is another NTNT technology that has similar advantages to MOCA ablation: minimal nerve injury, no tumescence, and results that are equal to or better than TT
techniques. e technology was developed by Rodney Raabe.
A specially formulated cyanoacrylate (CA) adhesive is embolized into the target vein utilizing a catheter that does not
allow solidication of the glue within it. Once in the vasculature, the glue sets and causes immediate occlusion. A foreign
body reaction incites an inammatory response in the vessel,
ultimately leading to brotic occlusion.21 e system consists
of a delivery catheter/sheath and a delivery gun (Figure 39.7).
First-in-man evaluations were conducted by Almeida etal.22
e initial technique involved the extrusion of CA 2 cm from
the SFJ. is proved to be a little too close, as there was egress
of the material into the common femoral vein in almost 20%
of cases. e current technique has undergone some modications in order to minimize complications.
39.3.2 Technique
1. Access vein percutaneously and pass a long 0.035-inch
guidewire to the SFJ or SPJ.
2. Insert a long 7-Fr sheath to within 5 cm of the SFJ.
Figure 39.7 Cyanoacrylate embolization (VenaSeal) system.
Figure 39.8 Cyanoacrylate embolization ultrasound cath-
https://t.me/med1917
eter and adhesive delivery.
3. A 5-Fr delivery catheter is placed through the 7-Fr
sheath and positioned 5 cm from the SFJ (Figure 39.8).
4. e delivery gun is attached and loaded with CA.
5. With each click of the delivery gun, 0.1 cc of CA is
delivered.
6. e rst injection is 5 cm from SFJ and the second is
1 cm distal (6 cm).
7. Pressure is applied for 3 minutes with the US probe
over this area.
8. e catheter is moved distally 3 cm and another 0.1 cc
is delivered.
9. Pressure is applied for 30 seconds to this segment.
10. Catheter is subsequently moved 3 cm, 0.1 cc is placed,
and pressure is applied for 30 seconds each time.
11. e entire vein is segmentally treated to the
insertionsite.
12. Post-procedure compression is optional.
13. An average of 1.3–1.5 mL of CA is used.
39.3.3 Technical pearls
Being too close to the SFJ or SPJ can lend to glue placement
in the common femoral/popliteal vein. e glue does not
break down overtime, so theoretically this can be a permanent nidus for clot formation. Catheter position needs to
be conrmed. Air pockets have been incorporated into the
catheter for improved visualization and echogenicity. e
3-minute compression time is important to allow sucient
“setting” of the glue so that the SFJ/SPJ is thoroughly protected. Doing nothing for 3 minutes can seem like a long
time for the operator, but be patient.
Nick Morrison, the principal investigator for the pivotal
U.S. VeClose trial, oers two other technical thoughts. In
the U.S. trial, epifascial veins were not treated, the thought
process being that the inammatory reaction could cause
skin damage and the cord of glue might be felt through the
patient’s skin. Dr. Morrison also feels that one should avoid
placement of glue immediately at the ostium of a large perforating vein to decrease the risk of deep system damage.
From a technical perspective, this NTNT method is
analogous to the TT method of radiofrequency ablation; it
39.3 CAE (VenaSeal™) 469
is a segmental ablation. e pullback rate variable has been
eliminated. is enables a more consistent and predictable
delivery of glue to the vein. e operator places the CA, pulls
the premeasured trigger, compresses, and moves to the next
segment. Eliminating pullback rate concerns and removing
tumescence simplies the technique for both patient and
physician.
39.3.4 Results
Initial studies were done in a swine model and reported in
2011.23 A rst-in-man study followed and 2-year follow-up
was recently reported.21 irty-eight patients were assessed
initially and 24 were available for 2-year follow-up. An
occlusion rate of 92% was achieved (Figure 39.9). More
importantly, the VCSS was still signicantly improved from
baseline and edema and pain were improved. ese procedures were conducted without tumescent anesthesia and no
post-operative compression was employed.
e European multicenter eSCOPE trial reported
a 92.9% occlusion rate at 12 months.24 e VCSS and
Aberdeen Varicose Vein Questionnaire showed subsequently improved scores. is highlights the importance of
QoL measures as outcomes and not solely occlusion rates.
As with all NTNT techniques, no nerve injury occurred.
ere was some form of phlebitis reaction in about 11% of
patients. is study was conducted without post-operative
compression.
e most recent trial as of this writing is the U.S. pivotal trial, VeClose.25 is trial was a non-inferiority trial
comparing CAE to radiofrequency ablation. All centers
had signicant radiofrequency technique experience and
there was a roll-in period for CAE before trial entry so that
investigators were over the learning curve. is trial did use
post-operative compression as a fair comparison to radiofrequency ablation. e 6-month occlusion rates were essentially the same; radiofrequency ablation: 94%; CAE: 99%.
More importantly, all measures of QoL were equal—pain
during procedure, ecchymosis, VCSS, European Quality of
Life 5 dimensions questionnaire (EQ-5D), and Aberdeen
Figure 39.9 Great saphenous vein at 6 months post-cya-
noacrylate embolization.
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