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444 Chapter 43 Endovenous laser treatment of superficial truncal veins
https://t.me/med1917
Groin neovascularization was the cause of varicose vein
recurrence in 33% of the EVLA with HL group and 0%
in EVLA alone, but recanalization rates were higher without HL (9% vs 0%). Incompetent tributaries as a cause of
recurrence were more common in EVLA alone (14% vs
0%). VCSS improved signicantly in both groups.
43.6.3 Complications
Although several complications have been reported, they
are relatively uncommon and do not affect the overall
safety of EVLA in treating venous insufciency. The term
minor complication refers to those requiring no or minimal
intervention, such as ecchymosis, saphenous nerve injury,
and mild thermal injury (Box 43.2.a). Major complications
include venous thromboembolism (VTE), severe infections,
and retained foreign body, among others (Box 43.2.b).
EVLA generally causes mild to moderate intraoperative pain; clinical trials show that postoperative pain is
less than HL/S and requires less analgesia (37, 41). Since
ecchymoses are common manifestations of endovenous
ablations and because they do not affect the return to normal activities, nor do they require treatment, they are not
considered a complication, and patients should be counseled accordingly. It is possible for heat complications, such
as skin burns and nerve injuries, to arise when there is a
shallow vein or unusual nerve anatomy. The incidence of
skin burns and hyperpigmentation are less than 0.5% (42,
43) and may occur when the vein lies epifascially. By using
adequate tumescent anesthesia, heat will be dissipated
and less will be transmitted directly to the overlying skin,
which will decrease the risk of burns and nerve injuries and
will also decrease postoperative pain. The rare, unsightly,
full-thickness burns require local wound care and infection monitoring. If they are apparent at the time of ablation, the skin can be excised, allowing for primary closure.
The prevalence of supercial thrombophlebitis has been
reported to be less than 5% (44) and responds well to the
usual clinical measures of nonsteroidal anti-inammatory
medications and compression. Bacterial infections occur
in less than 0.1% and respond to oral antibiotics, rarely
requiring surgical debridement (43).
Nerve injuries after EVLA are transient, occurring at a
rate of 1%–5% (45, 46). The presence of transient cutaneous paresthesia could result either from a needle stick or
a laser heat transfer in the mid-to-distal medial calf. Sural
nerve injury causes distal calf and lateral foot numbness,
which can last for up to a year, longer than a saphenous
BOX 43.2 Complications
a) Minor complications
• Hematoma
• Pain syndrome
• Seroma
• Temporary numbness
• Mild skin burns
• Supercial thrombophlebitis
• Hyperpigmentation
b) Major complications
• Severe infection
• Retained foreign
body
• Full-thickness burns
• Arteriovenous stula
• Venous thromboembolism
nerve injury. US visualization prior to the SSV puncture
could be helpful.
The development of arteriovenous stulas after EVLA
is also a rare event, occurring in only 0.2% of cases or
less (47). Symptoms may include leg swelling, or they may
remain asymptomatic following the procedure, with most
patients being diagnosed within 4 weeks. The mechanism
of formation may include accidental concomitant arterial
and venous puncture, as well as heat transfer and weakening of the arterial wall. An asymptomatic patent can be
treated nonoperatively.
As with any endovascular procedure, EVLA may result
in retained intravascular foreign bodies (sheaths, bers,
wires) (43), which require removal.
VTE is a known complication of endothermal procedures, with an overall incidence ranging between 0%
and 6% in most single-center retrospective studies (Table
43.1). The variations in incidence are likely owing to
inconsistencies in the timing of postprocedural US as
well as in the denitions, with some reports including
US evidence of thrombi without propagation into deep
veins (EHIT 1) (44, 48–51). EHIT 1 has mostly a benign
course, and it requires no treatment or surveillance (12)
(Figure 43.7).
Healy et al. (52) examined in a meta-analysis 52 studies on endothermal ablations and reported a 0.31% rate
of DVT in 48 patients (95% CI 0.2%–0.5%), as well as
0.1% pulmonary embolism (PE) in 0.1% of cases (95% CI
0.1%–0.2%). Among 10,325 patients, 302 cases of EHIT
were found (2.92%) but only 1.4% had EHIT >1. RFA and
EVLA groups yielded similar results when analyzed separately, with a combined rate of EHIT >1/DVT of 1.4% (95%
CI 0.003–0.032) vs 1.3% (95% CI 0.004–0.028). Aurshina
et al. (44) published a case series on acute thrombotic complications associated with 1811 endovenous thermal procedures. The overall thrombotic complication rates for RFA
and EVLA were 7.7% and 11.4%, respectively (p = 0.007).
These complications included EHIT in 5.9% and supercial
thrombophlebitis in the varicosities and their tributaries in
4.6%. The rate of EHIT >1 was 1.16%. Larger veins developed more thrombotic complications (mean vein diameter
6.7 ± 2.2 mm vs 5.6 ± 2.0 mm without a complication, p <
0.001), and the GSV was at higher risk compared to other
vein segments (GSV, 11.8%; SSV, 5.5%; AAGSV, 6.5%, p =
0.0001). AlGholi et al. (51) reported on 1230 limbs following EVLA of the GSV. EHIT occurred in 5.3% of limbs, and
it usually resolved within 1–4 weeks from the time of discovery. Female vs male (86% vs 73%; p = 0.02), GSV diameter
(6.7 ± 2.7 mm vs 6.0 ± 2.1 mm; p = 0.04), and competent
SFJ (41% vs 37%; p = 0.001) were statistically signicant
risk factors. In the Kane et al. (48) study, 528 EVLA procedures were examined; 388 (74%) were performed concurrently with stab phlebectomy. The incidence of EHIT was
5.1%, but no PE was reported. GSV diameter >7.5 mm was
associated with a higher risk of EHIT (adjusted OR, 2.83;
95% CI, 1.18–6.77, p < 0.02).
Although several risk factors have been identied in
several retrospective studies, their contrasting results do
not allow one to make any strong recommendations at the
present time on the use of thromboprophylaxis or postoperative surveillance (Table 43.1). When instituted, the use of
anticoagulant agents during EVLA is generally considered
43.7 Conclusion 445
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TABLE 43.1 Reported risk factors associated with the development of endothermal heat-induced thrombosis
(combined EHIT I–IV) in selected endovenous laser ablation (EVLA) literature
Authors,
year
Puggioni
et al., 2005
Knipp et
al., 2008
Chi et al.,
2011
Kane et
al., 2014
Suan et
al., 2015
Shutze et
al., 2015
Aurshina
et al., 2017
AlGholi et
al., 2019
Abbreviations: GSV = great saphenous vein, SSV = small saphenous vein, AAGSV = anterior accessory great saphenous vein, PV = perforator veins,
GFR = glomerular filtration rate, SFJ = saphenofemoral junction.
Cohort
no.
77 GSV, SSV Phlebectomies 97%, perfo-
443 GSV Phlebectomies 21.4%, per-
360 GSV, SSV – 5% Female sex, age>60, hyperlipidemia, history of
528 GSV, SSV Phlebectomies 74% 5.1% Vein diameter >7.5 mm
2168 GSV, SSV, and
1439 GSV, SSV Phlebectomies 30.4% 6% Higher average energy delivery, vein diameter
344 GSV, SSV,
1230 GSV – 5.3% Female sex, vein diameter >7 mm, and compe-
Veins treated
by EVLA
AGSV
AAGSV, and PV
Adjunctive procedures % EHIT (all
classes)
2.3% Age >50
rator interruption 6%
7.9% None identied
forator ligation 8.2%
Phlebectomies 74% 0.9% Male sex, age >60, GSV vein diameter >8 mm,
– 5.9% Vein diameter >7 mm and type of vein (GSV
EHIT risk factors
phlebitis and GFR <65
SSV >6 mm, and concomitant phlebectomies
>9 mm, stab phlebectomy, and CEAP
>AASV >SSV)
tent SFJ
43
43.7 Postoperative transverse DUS image 72-hours post-endothermal ablation demonstrating hyperechoic thrombus in the proxi-
mal GSV peripheral to the supercial epigastric vein (EHIT 1a). (A) Saphenofemoral junction. (B) Supercial epigastric vein and (C)
Thrombus in proximal GSV.
safe, as it does not seem to signicantly increase periprocedural bleeding or EVLA treatment failures as consistently
described in several reports (53, 54).
43.7 CONCLUSION
EVLA has been proven to be a safe, effective, and durable treatment for symptomatic incompetent truncal veins
of the lower extremities. It is a well-tolerated procedure
with rare and relatively minor complications that offers
decreased morbidity and overall improved QOL compared
to conventional stripping.
Various types of laser bers, wavelengths, and radial
tips are available for EVLA, and there may be nuanced
advantages and disadvantages for each laser type. Postprocedural duplex studies are often performed to identify
thrombotic events and recanalization, but the necessity of
this imaging practice is still uncertain. Intersocietal clinical practice guidelines advocate for thermal ablations as
rst-line treatment over stripping if technology or expertise in endovenous ablation is available or if the venous
446 Chapter 43 Endovenous laser treatment of superficial truncal veins
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anatomy does not preclude endovenous treatment (4).
The most meaningful goals of venous treatments are the
relief of symptoms, prevention of disease progression, and
improvement of QOL. Because most patients treated with
EVLA also undergo adjunctive microphlebectomy or foam
sclerotherapy, overall clinical success is likely to depend
on the combination of procedures. There are several risk
factors for preoperative thrombotic events, but the results
of the studies are inconsistent, so perioperative thromboprophylaxis needs to be individualized. The treatment for
EHIT should be in accordance with the AVF/SVS consensus
statement guidelines (12).
Guidelines and Consensus Statements 43.0 of the American Venous Forum on endovenous laser treatment of
supercial truncal veins*
No. Guidelines Grade of
43.1 For patients with symptomatic varicose veins and axial reux in the great saphenous vein (GSV) who are candidates for intervention, we recommend treatment with
endovenous ablation over high ligation and stripping (HL&S) of the GSV.
43.2 For patients with symptomatic varicose veins and axial reux in the small saphenous vein (SSV) who are candidates for intervention, we recommend treatment with
endovenous ablation over ligation and stripping of the SSV.
43.3 For patients with symptomatic varicose veins and axial reux in the AAGSV or
PAGSV who are candidates for intervention, we suggest treatment with endovenous ablation, with additional phlebectomy, if needed, over ligation and stripping of
the accessory vein.
43.4 For patients with symptomatic varicose veins and axial reux in the GSV who place
a high priority on the long-term outcomes of treatment (quality of life and recurrence), we suggest treatment with endovenous laser ablation, radiofrequency ablation, or high ligation and stripping over physician-compounded ultrasound-guided foam sclerotherapy because of long-term improvement of quality of life and
reduced recurrence.
43.5 For patients with symptomatic varicose veins and axial reux in the SSV, we suggest treatment with EVLA, RFA, or ligation and stripping from the knee to the upper
or mid-calf over physician-compounded ultrasound-guided foam sclerotherapy
because of long-term improvement of quality of life and reduced recurrence.
43.6 For patients with symptomatic varicose veins and axial reux in the AAGSV or
PAGSV who place a high priority on the long-term outcomes of treatment (quality
of life and recurrence), we suggest treatment of the reuxing supercial trunk with
endovenous laser ablation, radiofrequency ablation, or high ligation and stripping,
with additional phlebectomy, if needed, over physician-compounded ultra-
recommendation
1
(strong)
1
(strong)
2
(weak)
2
(weak)
2
(weak)
2
(weak)
Quality of
evidence
B (moderate)
C
(low to very low)
C
(low to very low)
B (moderate)
C
(low to very low)
C
(low to very low)
life and reduced recurrence.
Consensus Statement
43.7 In patients with an epifascial or supercial saphenous vein, thermal ablation may result in skin burns, hyperpigmentation, or
induration, while nonthermal techniques may cause hyperpigmentation or induration. Mini-phlebectomy or limited stripping is
safe and effective if the saphenous vein is close to the skin (<0.5 cm).
* Based on recommendations of Reference 55.
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48. Kane K, Fisher T, Bennett M, et al. The
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49. Shutze WP, Kane K, Fisher T, et al. The
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heat-induced thrombosis incidence after
endovenous laser ablation. J Vasc Surg
Venous Lymphat Disord. 2016;4(1):36–
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laser: Incidence, progression, and risk
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51. AlGholi HH, Aljasser AA, Alyahya IA, et
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★52. Healy DA, Kimura S, Power D, et al. A
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thermal ablation of the great saphenous vein. Eur J Vasc Endovasc Surg.
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53. Westin GG, Cayne NS, Lee V, et al.
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CHAPTER
44
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Cyanoacrylate glue treatment
of incompetent superficial truncal veins
Raghu Kolluri and Andrew Pollard
44.1 INTRODUCTION
There has been a transformation within the guidelines over
the past two decades for the treatment of CVI, with endoluminal therapies being preferred treatments over surgical
vein stripping. In the updated 2022 SVS/AVF/AVLS Clinical
Practice Guidelines, endoluminal thermal or nonthermal,
nontumescent ablation techniques should be performed
over surgical vein stripping in patients with symptomatic
GSV reux (1). Nonthermal nontumescent (NTNT) endoluminal techniques that do not require tumescent anesthesia include cyanoacrylate glue (CAG), mechanochemical
ablation (MOCA; ClariVein [Merit Medical, South Jordan,
UT], and proprietary polidocanol endovenous microfoam
(PEM; Varithena [Boston Scientic, Marlborough, MA].
These have all been approved for use in saphenous veins
by the U.S. Food and Drug Administration (FDA). While
physician-compounded foam sclerotherapy is widely utilized, its use is considered off-label in the United States.
The lack of need for tumescent anesthesia and the multiple
associated sticks make NTNT therapies attractive to some
patients. Elimination of skin and nerve injuries and the
ability to treat to the “lowest point of saphenous reux”
are also a few added advantages associated with NTNT
therapies. This chapter will focus on CAG therapy for the
management of CVI.
First synthesized for military use in 1942, CAG was initially used for industrial purposes due to its strong cohesion
properties. Furthermore, it has many benecial properties.
These include strong adhesion, rapid polymerization, and
bacteriostatic and hemostatic properties. Because of these
properties, it is used in various surgical applications such
as intracranial malformations, pelvic varices, and gastric
varices (2).
CAG used in treating saphenous veins chemically consists of n-butyl cyanoacrylate (n-BCA). As of January 2023,
there are three commercially available devices approved in
the United States and Europe that deliver CAG to treat
great saphenous vein (GSV) and small saphenous vein
(SSV). VenaSeal Closure System (Medtronic, Minneapolis,
MN) is the only U.S. FDA-approved CAG therapy. VenaSeal is the most widely available CAG, with approvals in
several countries in North and South America, Europe,
Asia, Africa, and Oceania. The other products with published literature include VariClose (Biolas, Inc., Ankara,
Turkey) and VenaBlock (Invamed, Ankara, Turkey). These
two, along with VenaSeal, have Conformité Européne (CE)
approval. The important differences among these three,
such as viscosity, polymerization, device, and delivery characteristics, are elaborated in Table 44.1.
44.2 MECHANISM OF ACTION OF CAG
In 2011, a preclinical swine model demonstrated that direct
contact of CAG with venous walls induces an inammatory
reaction that leads to brotic occlusion of the vein. After
polymerization, the CAG conforms to the vessel’s shape and
forms a cast (3). Tissue response to CAG was described in
three studies. At 10 minutes after the exposure to VenaSeal,
Shaidakov et al. demonstrated mast cell degranulation in
the perivascular space (4). In another study with VenaBlock,
a 1-week biopsy revealed a coating of the vein lumen with
erythrocytes without any histiocytes or granulomas. However, small luminal foci of isolated foreign body histiocytes
were noted by 6 weeks. At 1 year, there was a lack of endothelial lining in the target vein. Lymphoid hyperplasia and
brosis of the surrounding tissue were noted, along with
cavitated foreign body granulomas, with foreign body–type
giant cells in the perivascular and extravascular spaces (5).
A Korean report of biopsy at 2 years reported multinucleated giant cells distributed throughout the media without
an adventitial inltration (6).
Regarding the physical properties, among the available
CAGs, VenaSeal (n-BCA) has the highest viscosity and longest polymerization time upon contact with blood. VenaSeal is also pliable after polymerization by design to allow
for exion and torsion. The other CAGs are less viscous
and less pliable after polymerization (7).
44.3 CLOSURE RATES AND
PATIENT-REPORTED OUTCOMES
The rst feasibility study for endovenous CAG use by
Almeida et al. studied VenaSeal in 38 symptomatic patients
with incompetent GSVs. Per the trial design, there was no
tumescent anesthesia used, no postprocedural compression, and no adjunctive therapies were used for 6 months.
DOI: 10.1201/9781003328971-49
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TABLE 44.1 Differences in CAG devices
Characteristics/device VenaSeal VariClose VenaBlock
Manufacturer Medtronic Biolas Invamed
Country United States Turkey Turkey
CE marked Ye s Yes Yes
FDA approval Yes (in 2015) No No
Glue consistency Viscous Syrup Liquid
Time to polymerization 20 s 3–4 s 1–5 s
Sheath 7F 5F, 6F 6F
Delivery catheter 5F, 91 cm 4F, 83 cm 6F, 100 cm
Catheter tip distance from SFJ 5 cm 3 cm 3 cm
Glue release Segmental Continuous release Continuous release
* Table modified from Bissacco et al. (2).
At 12 months follow-up, there was a 92% occlusion rate
reported, and the mean Venous Clinical Severity Score
(VCSS) improved from 6.1 ± 2.7 baseline to 1.5 ± 1.4 at
12 months (P < 0.0001) (8). The second study investigating
VenaSeal was eSCOPE, a prospective European multicenter
study enrolling 70 patients. The trial design was similar to
the feasibility study with a primary endpoint of 12 months.
At 12 months, a closure rate was reported of 92.9% (66
patients). These patients were then followed for an additional 36 months. The reported closure rates at 6, 12, 24,
and 36 months were 91.4%, 90.0%, 88.5%, and 88.5%,
respectively. The mean VCSS also improved from a baseline of 4.3 to 0.9 at the primary endpoint of 36 months (9).
The pivotal trial in the United States, the VeClose Study,
was a prospective, multicenter, 1:1 randomized control
trial that compared VenaSeal CAG with radiofrequency
ablation (RFA). Its design was to demonstrate a statistical
noninferiority of VenaSeal CAG with RFA. Two hundred
and twenty-two subjects with symptomatic GSV incompetence were randomized to receive CAG (n = 108) or RFA
(n = 114). Data assessments of the study included VCSS;
clinical, etiology, anatomy, and pathophysiology (CEAP);
EuroQol-5 Dimension (EQ5D); and Aberdeen Varicose
Vein Questionnaire (AVVQ). At the study’s primary endpoint, complete closure of the GSV at 3 months was 99%
in the VenaSeal CAG group and 96% in the RFA group.
The subjects were followed for 5 years. The occlusion
rates at 12, 36, and 60 months for VenaSeal were noninferior to RFA (97.2% vs 97.0%, 94.4% vs 91.9%, and
91.4% vs 85.2%, respectively). Additionally, at the end of
5 years, the VenaSeal CAG group demonstrated sustained
improvements in EQ5D and other quality-of-life measures
(10, 11). In a network meta-analysis, VenaSeal was compared to endovenous laser ablation (EVLA), RFA, MOCA,
sclerotherapy, and surgery for management. Anatomic
success (complete closure of treated vein within 6 months
after intervention) was assessed as the primary outcome.
Health-related quality of life (HRQoL), EQ5D, AVVQ,
VCSS, pain scores, and adverse events were evaluated as
secondary outcomes. For the primary outcome measure
(anatomic success), the VenaSeal system had the highest
probability of being ranked rst (P = 0.980). For secondary outcome measures, however, other therapies fared
better than VenaSeal except for postoperative pain, which
VenaSeal ranked rst in. VenaSeal also demonstrated the
lowest adverse events compared to other therapies in this
meta-analysis (12). In the WAVES study, a prospective, sin-
gle-center registry reported results of the VenaSeal cohort
of patients with symptomatic venous reux disease in
small saphenous anterior accessory saphenous veins and in
GSVs up to a vein diameter of 20 mm. Vein occlusion was
achieved in 99% of the treated veins at 3 months (13, 14).
Postmarket studies have been published from outside
the United States as well. In a South Korean study, VenaSeal was compared with surgical stripping in an open-label, multicenter, randomized control trial. The authors
reported complete vein closure in both groups at 3 months,
while postoperative pain scores and ecchymosis were signicantly lower in the VenaSeal group. VCSS scores and
QoL scores were similar in both groups (15). In another
study from Singapore in a cohort of 140 treated veins, closure rates of 99.3% and 97.6% were reported at 6 and
12 months, respectively. But the revised VCSS and QoL
decreased at 3 months and were sustained from 3 months
to 12 months (16).
In 2016, the rst study investigating the use of VariClose for the treatment of incompetent GSVs (n = 169)
and SSVs (n = 11) was reported. This trial was a retrospective study involving 180 patients, which demonstrated
a 100% closure rate immediately following the procedure
and at the mean follow-up of 5.5 months. Furthermore,
there was an improvement in VCSS (preprocedure: 10.2,
after 3 months: 3.9, p < 0.001) (17). Eroglu et al. reported
success rates of 100%, 98.3%, 96.6%, and 94.1% at 3, 6,
12, and 30 months, respectively, with VariClose, with sustained improvements in the VCSS at 30 months (18). In a
systematic review of several studies from Turkey (2), which
included 1000 cases (GSV, n = 947 and SSV, n = 53), the
closure rates at 6, 12, and 30 months were 97.3%, 96.8%,
and 94.1%, respectively. Due to the included studies having varying methods for obtaining VCSS, CEAP, or QoL
data points, analysis was limited.
In a retrospective Polish study, VenaBlock was compared to endovenous laser therapy in 89 patients with
symptomatic venous disease (C2–C4). At 2 years, recanalization rates were signicantly higher in the VenaBlock
44.6 VenaSeal technique 451
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cohort compared to laser (37.2 vs 8.7%). Patient-reported
outcomes were not reported in this study (19). Another
small single-operator/investigator report of 29 patients
(39 treated veins) with symptomatic venous insufciency
(C2–C6) demonstrated vein occlusion of 100%,100%,
and 97.2% at 2 weeks and 3 and 6 months, respectively.
Patient-reported outcomes, including VCSS, EuroQoL, and
AVVQ, reported improvements as well (20).
In summary, CAG demonstrated favorable anatomic
success rates and improved patient-reported outcomes.
VenaSeal CAG is the most studied CAG, with studies
reported from within the United States and other countries.
44.4 VenaSeal IN SEVERE VENOUS
DISEASE AND VENOUS LEG
ULCERS (VLUS)
O’Banion et al. compared VenaSeal with RFA in C6
patients. This was a retrospective study of 119 patients
with VLUs, without an active infection. The median follow-up was 105 days (range, 44–208 days). The median
time to wound healing was signicantly shorter for
VenaSeal than for RFA (43 vs 104 days; P = 0.001). Two
patients in the VenaSeal group developed a postprocedural infection requiring oral antibiotics (21). Two studies
from Singapore evaluated VenaSeal in patients with severe
venous disease. The rst reported outcomes in 103 procedures, including GSV, SSV, and AASV. A reported 65/93
legs (69.9%) had C4–C6 disease. The study demonstrated
> 90% GSV closure rates as other studies up to 1 year,
with high satisfaction rates and low periprocedural pain
(22). Another study from Singapore studied VenaSeal in
43 VLUs. The time to heal from the procedure was 73.6
+/– 29.1 days, with primary closure rates of 100% at 3
months. There were no signicant adverse events except
for one deep vein thrombosis (DVT) (23).
Upon completion of the VenaSeal Spectrum trial, an
ongoing, large, global, postmarket registry will hope to
understand better VenaSeal’s role and safety in patients
with VLU (24). But to date, based on published literature,
VenaSeal seems safe and effective in patients with severe
venous disease and VLUs.
CAG adhesive in the eSCOPE or VeClose trials (9, 11). Furthermore, in the VeClose trial, three subjects (2.8% vs 2.6%
RFA group) had paresthesias in the treatment zone. Access
site infection was also reported in the VeClose trial, albeit
very low in 0.9% of subjects (0.9% in the RFA group) (11).
However, phlebitis is the most commonly reported complication of VenaSeal, ranging from 4% to 20% (7, 26).
The potential adverse effects as per the instructions for
use for VenaSeal include foreign body reaction, arteriovenous stula; bleeding from the access site; DVT; embolization of the CAG; PE; hematoma; hyperpigmentation;
hypersensitivity or allergic reactions to cyanoacrylates
(urticaria, shortness of breath, and anaphylactic shock);
access site infection; pain; paresthesia; phlebitis; SVT, erythema, or ulceration at the injection site; vascular rupture;
perforation; and visible scarring (27).
Of all of the adverse events mentioned, allergic/hypersensitivity reactions to n-BCA are the most commonly
raised potential concerns with this therapy. A study by
Park that included 63 limbs treated with VenaSeal reported
“abnormal skin reaction,” including erythema, itching,
pain, and tenderness in 23.5% of the 34 patients, with full
recovery at 2 weeks (28). One subject in the WAVES trial
had full body hives that resolved with antihistamines and
oral corticosteroids (13). Other investigators have reported
similar allergic reactions (5, 29–32). In a recent consensus
document, the Australasian College of Phlebology specically reviewed the potential hypersensitivity reactions (7).
They summarized that postprocedural, inammatory, and
hypersensitivity reactions were reported in 10%–20% of
the treated patients. These included type I and type IV
hypersensitivity reactions and irritant contact dermatitis.
This consensus document recommended a maximum limit
of 10 mL of CAG per session. They also state that since
the mechanism of action is by creating foreign body granulomas, CAG must not be used in patients with autoimmune, granulomatous disorders and severe or uncontrolled
inammatory disorders. They recommend exercising caution in patients with systemic disorders or infectious states
and using thermal ablations or sclerosants in these situations. The adverse events in important clinical trials can be
reviewed in Table 44.2.
44.6 VenaSeal TECHNIQUE
44
44.5 POTENTIAL COMPLICATIONS
Overall, CAG is a safe treatment method for venous insufciency, associated mostly with mild complications. In the
initial feasibility study, eSCOPE trial, and VeClose trial,
phlebitis was the most reported adverse event (9, 11).
The reported rates of phlebitis concerning the use of CAG
adhesive were 15.8%, 11.4%, and 20%, respectively, in
the three trials. In a real-world short-term outcomes study,
21% of 235 patients who underwent VenaSeal ablation
developed self-limiting phlebitis (25).
These studies also reported very low rates of venous
thromboembolism. The feasibility study reported one DVT
in a subject at 31 months unrelated directly to the procedure (8). There were no reported DVT/PEs with the use of
44.6.1 Patient selection
The appropriate patient must have signs and symptoms of
venous insufciency and duplex ndings of reux greater
than 0.5 seconds in the target saphenous vein and a patent
deep venous system. The vein conduit must be straight and
conducive to catheter access and navigation, although this
may be a relative characteristic based on operator experience. Absolute exclusion includes previous hypersensitivity
reactions to the VenaSeal adhesive or cyanoacrylates, acute
supercial thrombophlebitis, thrombophlebitis migrans,
and acute sepsis. Relative exclusion criteria will consist of
vein tortuosity, an extensive list of allergies, and subdermal
veins. The recommendations from the Australasian College
of Phlebology are also good practices in selecting appropriate patients (7).
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TABLE 44.2 Adverse events with CAG
Adverse Events→
Study↓
Almeida (3, 8) 16% NR, 7.9% 0 NR
Morrison (10, 11) 20% 4% 0 NR
Proebstle (9) 11.4% NR 0 NR
Gibson (13,14) 20% NR 0 2%
Park (28) NR NR 0 11.4%
Phlebitis Superficial thrombophlebitis DVT/PE Hypersentivity Reaction
44.1 VenaSeal dispenser gun connected to a 3-mL syringe. The 5F delivery catheter is primed with CAG up to the distal laser marker
(red arrow), which is located 3 cm from the delivery catheter tip. This setup is on the “dry side” of the procedure table.
The authors are experienced only in the VenaSeal system since it is the only CAG available in the United States.
Hence, only this procedure will be described in this chapter.
5. Flush the dilator using a saline-lled syringe to prevent
blood from backwashing the dilator.
6. Advance the 5F delivery catheter (preloaded with
CAG) to the saphenofemoral junction (SFJ) (Figure
44.6.2 Procedure kit
The VenaSeal Closure System is a self-contained, sterile,
single-patient kit consisting of CAG and components of the
CAG delivery system. The kit includes a dispenser gun, 5 mL
of CAG in a small vial, a 5F delivery catheter, a 7F introducer
with a 5F dilator, two dispenser tips, two 3-mL syringes, and
a 0.035-inch guidewire (Figures 44.1 and 44.2).
44.4). Locate the catheter tip with ultrasound and conrm the tip is 5.0 cm caudal to the SFJ.
7. Using the ultrasound probe, apply pressure 2–3 cm
cephalad to the tip of the catheter.
8. Administer approximately 0.10 mL of CAG twice
(achieved by depressing the gun handle of the dispenser
for 3 seconds) 1 cm apart at this site.
9. Hold pressure with the ultrasound probe for 3 minutes.
10. Withdraw the catheter for 3 cm, and administer an
44.6.3 Procedure description
1. Identify the most caudal reux point of the to-be-treated
vein with ultrasound and administer local anesthetic.
2. Access the vein using the Seldinger technique.
3. Place the 7F introducer sheath over the 0.018 wire and
insert the dilator into the introducer sheath.
4. Exchange the 0.018-inch guidewire with a 0.035-inch
J-wire guidewire and pass the 7F dilator over it (Figure
44.3).
additional 0.10 mL of CAG.
11. Hold manual compression for 30 seconds.
12. Continue the procedure with CAG injections every 3
cm with the 30-second ultrasound probe/manual compression sequence. Continue until the entire length of
the targeted vein segment has been treated.
13. Remove the sheath and the catheter. At the access site,
hold the compression.
14. Conrm venous occlusion of the targeted and treated
vein with duplex ultrasound (Figure 44.5A).
44.6 VenaSeal technique 453
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44.2 This portion of the table, most importantly, consists of the ushable components (the “wet side”), including the micropuncture
needle, 0.018-inch guidewire, 7 Fr introducer, 5 Fr dilator, and 0.035-inch guidewire.
44
44.3 The GSV is accessed via a 7F access sheath and dilator. The 7F VenaSeal introducer and 5F dilator are passed over the 0.035-
inch guidewire into the GSV.
44.4 The 5F dilator is exchanged for the primed 5F CAG delivery catheter.
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