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384 Chapter 37 PCF sclerotherapy for ablation of superficial truncal veins and varicose tributaries
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37
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CHAPTER
Endovenous microfoam sclerotherapy
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for ablation of superficial truncal
veins and varicose tributaries
38.1 INTRODUCTION
In recent years, commercially manufactured microfoam
sclerotherapy (MFS) of reuxing truncal and tributary
veins has been introduced as a nonthermal alternative to
previously established surgical and thermal techniques (i.e.,
ligation and stripping, radiofrequency, and laser ablation).
In this chapter, we will review background information,
clinical indications, technical details, and evidence-based
practice with Varithena microfoam.
38
Juan Carlos Jimenez and Peter F. Lawrence
38.2 BACKGROUND
38.2.1 Foam solutions
Varithena (Boston Scientic, Marlborough, MA) was
approved in 2013 by the U.S. Food and Drug Administration (FDA) for treatment of incompetent great saphenous
veins (GSVs), accessory saphenous veins (AASVs), and visible varicosities of the GSV system above and below the
1
It is a 1% injectable polidocanol solution composed
knee.
of an oxygen–to–carbon dioxide ratio of 65:35 with a low
nitrogen concentration (<0.8%). This microfoam (MF)
demonstrates a uniform density, size, and stability with
a small bubble size (median diameter <100 uM) relative
to physician-compounded foam (PCF) using the Tessari
method (Figure 38.1).
Microfoam differs from PCF, which is created at the
bedside by mixing room air with liquid polidocanol (or
other sclerosing agents) (Figure 38.1). In the form of a
mixed foam, the solution can treat larger-diameter veins
as opposed to spider and reticular veins, the primary indication for liquid polidocanol. With the Tessari method, a
syringe of liquid sclerosant is connected to another syringe
via a three-way stopcock. The stopcock valve is turned
30–45 degrees from its neutral position and the syringes
are mixed back and forth, creating foamed bubbles. A 4:1
room air–to–liquid ratio is preferred to maintain small
bubble size. The foam should then be injected into the target vein within 60–90 seconds. Because room air contains
38.1 A comparison of physician compounded foam (a) and
Varithena microfoam (b). Microfoam is composed of smaller
and more uniform bubbles compared with PCF.
approximately 78% nitrogen, PCF is unlike microfoam
and contains a relatively high nitrogen concentration.
In a comparative study comparing MF and PCF, Carugo
and colleagues demonstrated smaller bubble size, along
with more uniform bubble size distribution and increased
stability with MF.
nitrogen concentration and small bubble size are protective
against microcirculatory obstruction and cerebral ischemia
from potential cerebrovascular gas bubbles embolizing following treatment with intravenous foam.
2
Reported evidence suggests that a low
3
38.2.2 Activation and mixture process
Varithena is dispensed from a patented proprietary canister device with a transfer unit which activates the MF
prior to patient use (Figure 38.2A). To initiate gas transfer, the oxygen and polidocanol canisters are connected
and twisted. Activation of the MF takes 1 minute. The
oxygen canister is then removed and the Varithena transfer unit is then attached and rotated clockwise. A syringe
is then inserted, allowing MF to ll it (Figure 38.2B). The
instructions for use recommend wasting 3–5 mL prior to
lling the syringe with usable MF. In our experience, we
have demonstrated good results wasting only 1–2 mL per
session.
DOI: 10.1201/9781003328971-43
387387
388 Chapter 38 Endovenous MFS for ablation of superficial truncal veins and varicose tributaries
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38.2B Following activation, a syringe is attached to the canister
and allowed to passively ll with microfoam prior to treatment.
38.2A Varithena is dispensed from a patented proprietary can-
ister device with a transfer unit which activates the MF prior to
patient use.
The solution is then directly injected into the target vein
(see “Techniques” section). Polidocanol works as a nonionic surfactant sclerosing agent. It attaches to the lipid cell
membrane of the venous endothelium, resulting in disruption of the osmotic barrier and damage to the endothelium
with resultant vasospasm.
4
The endothelial destruction
leads to thrombus formation and occlusion of the venous
lumen. Chronic thrombosis of the vein results in lling of
the venous lumen with brous connective tissue.
38.3 TECHNIQUES
We treat patients with symptomatic and incompetent
(reux >0.5 seconds) GSV and AASV with MFS based on
the manufacturer’s instructions for use (IFU) (Varithena,
Boston Scientic, Marlborough, MA). We also treat small
saphenous veins (SSVs); however, this is considered “off-label” use because Varithena is not FDA approved for this
anatomic location.
Because the efcacy of this technique requires maximal intraluminal contact between the sclerosant and the
intraluminal venous endothelium, our group has published outcomes following the performance of adjunctive
techniques to optimize this mechanism of action.
5
Careful
preoperative and intraoperative (by the clinician) duplex
ultrasound examinations are important to characterize
the target vein(s) and to identify any nearby perforator
veins (Figure 38.3). Because the presence of perforators in
the target vein may facilitate transit of MF into the deep
venous system,
recognition and identication of perforator
veins are important. For patients with numerous or large
perforators in the target vein, thermal ablation techniques
may be preferrable to MF.
We access truncal veins either at the knee or distal leg or
ankle. Sterile ultrasound-guided venous access is obtained
with either a micropuncture needle and 4F sheath or with
a 21G buttery needle. After obtaining access and prior
to MF injection, the target limb is elevated to greater than
45 degrees using a tilt-table. The purpose is to drain and
decrease blood passively from the target vein centrally. We
then inject 10 mL of sterile saline into the vein to further
displace blood from the vein lumen. In our experience, this
allows treatment of target veins using a smaller volume of
MF. Although the maximal amount of recommended MF
volume based on the Varithena IFU is 15 mL, we have been
able to achieve successful venous closure with signicantly
lower MF volumes in our clinical practice.
5
During injection into the truncal veins, perforator veins are occluded to
prevent migration into the deep venous system.
Immediately after the procedure, we evaluate the femoral
and popliteal veins for acute thrombus with intraoperative
ultrasound examination, and compressibility is assessed.
The treated limb is compressed in the elevated position
(>45 degrees) with abdominal pads overlying the treated
veins and long-stretch bandages. We believe this technical
detail is important because it prevents early reintroduction
38.4 Results: level 1 evidence for microfoam sclerotherapy 389
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38.3 Duplex mapping of perforators in the target vein by the treating physician is important to prevent migration of microfoam into
the deep venous system.
38
TABLE 38.1 Adjuvant techniques to minimize thrombotic complications following microfoam ablation
1. Preoperative duplex ultrasound performed by our vascular ultrasound laboratory and by the proceduralist at the time of the operation. Large perforator veins were localized and mapped before injection of microfoam.
2. Limb elevation to greater than 45 degrees
3. Injection of 10 mL of sterile saline before microfoam infusion to displace blood from the vein. In theory, the purpose is to limit the
volume of foam administered and maximize microfoam contact with the luminal surface.
4. Attempted limitation of microfoam volume to 5 mL or less (if possible)
5. Compression of the axial vein 5 cm caudal to the saphenofemoral or saphenopopliteal junctions and compression of perforator veins
during microfoam injection
6. Dorsiexion and plantar exion of the ipsilateral foot and ankle for 20 repetitions after microfoam injection
of intraluminal blood into the recently treated vein and
may prevent early recanalization. During this time, we also
ask patients to plantar ex and dorsiex the ipsilateral
ankle 20 times to increase ow through the deep venous
system. We encourage patients to walk frequently and to
avoid prolonged standing or sitting following their procedure. Utilization of these adjunctive techniques with MFS
has resulted in excellent early closure rates, overall symptomatic improvement, and a low incidence of postoperative adverse thrombotic events (ATEs)
5.
(Table 38.1).
38.4 RESULTS: LEVEL 1 EVIDENCE FOR
MICROFOAM SCLEROTHERAPY
The safety and efcacy of MFS have been validated following level 1 randomized studies
ISH-1 study by King and colleagues was a multicenter trial
6–8
(Table 38.2). The VAN-
that randomized 279 patients to treatment with different
concentrations of polidocanol MF (0.125%, 0.5%, 1%,
2%) or placebo.
and associated supercial tributaries. The primary endpoint was patient-reported symptomatic improvement.
Secondary endpoints included improved appearance of
visible varicose veins from baseline to week 8. The quality-of-life instrument VVSymQ demonstrated signicant
symptomatic improvement in the MF groups compared
with placebo (p < 0.0001). The MF groups also demonstrated signicantly improved appearance at all therapeutic
dose concentrations. The most common ATE was supercial thrombophlebitis, which occurred in 10.5% of study
patients. Twenty-seven patients experienced deep venous
ATEs including 15 proximal deep vein thrombus extensions (PDVTEs) and 12 peripheral deep venous thromboses
(DVTs). All resolved with oral anticoagulation, and no pulmonary emboli were noted. No neurologic complications
or symptomatic embolic events were reported.
7
Veins treated included the GSV, AASV,
390 Chapter 38 Endovenous MFS for ablation of superficial truncal veins and varicose tributaries
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TABLE 38.2 Summary of randomized trials evaluating polidocanol microfoam
Study No. of
King et al. (VANISH-1) 279 63% 80.4% –3.70 2.5%
Todd et al. (VANISH-2) 232 77.8% 86% –5.15 6.1%
Gibson et al. (Varithena
013 Group)
* HASTI: heaviness, achiness, swelling, throbbing, itching.
patients
77 *HASTI Score Mean change
Symptom improvement
(1% MF)
from baseline 30.7 (not reported as percentage)
Elimination of reflux
and/or closure (1% MF)
90% –3.4 9.6%
Mean change
in VCSS
Deep venous
thrombosis
The VANISH-2 was a 5-year, randomized, multicenter,
parallel group study. Patients (n = 232) were randomized
to treatment with MF concentrations of 0.5%, 1%, and
placebo.
8,9
Similar to VANISH-1, target veins included the
GSV, AASV, and associated supercial tributaries. The mean
vein diameter treated was 8.7 mm (range 3.1 mm to 19.4
mm). The primary efcacy endpoint was patient-reported
improvement in symptoms, as measured by the change
from baseline to week 8 in the 7-day average electronic
daily diary VVSymQ score. The co-secondary endpoints
were the improvement in appearance of visible varicosities
from baseline to week 8 as measured by patients and by an
independent physician review panel.
There were signicant improvements for both the
0.5% and 1.0% treatment groups compared with placebo.
Overall, there was a 64% improvement in symptoms in
the treatment groups compared with 22% in the placebo
group (p < 0.0001). Statistically signicant improvement in
appearance was also noted in both treatment groups. Elimination of reux and/or complete occlusion of the GSV was
achieved in 83% and 86% of patients who received 0.5%
and 1.0% polidocanol, respectively. Adverse thrombotic
events occurred in 10.4% of patients. Thrombus extension
into the common femoral vein occurred in nine patients
(3.9%). None were occlusive. There were six proximal
(2.6%) and seven distal (3%) DVTs. Two patients developed gastrocnemius thrombi. Half of the patients received
anticoagulation, and the remainder were managed with
nonsteroidal anti-inammatory medications and/or compression and observation.
Another study by Gibson and colleagues randomized 77
patients to treatment with 1% polidocanol MF (n = 39) or
placebo (n = 38) during the blinded portion of the study.
10
Subsequently, 34 placebo-group patients were crossed over
into treatment with 1% polidocanol MF. Like the VANISH
trials, symptoms, and appearance both improved signicantly in the Varithena group. This study initially allowed
<30 mL of MF per treatment. However, because there was
a trend suggesting higher occurrence of ATEs with higher
volumes, the protocol was amended mid-study to a maximum of 15 mL per procedure, the current IFU-approved
volume. Overall, the incidence of common femoral vein
thrombus extension was 4.1%, and the incidence of new
DVTs was 9.6%. All but one venous thrombus resolved
without clinical signicance. A summary of level 1 evidence
validating Varithena 1% polidocanol MF compared with
placebo can be found in Table 38.2.
38.5 RESULTS: REAL-WORLD
CLINICAL OUTCOMES
Follow-up studies have validated the use of Varithena MFS in different anatomic locations across a wide
range of CEAP clinical classes.
we treated below-knee supercial truncal veins (GSV n
= 45, SSV n = 23) with MFS for symptomatic reux.
The study population was mostly composed of patients
with advanced chronic venous insufciency, with 63% of
patients with a CEAP clinical class of 4–6 at the time of
treatment. Most patients (78%) demonstrated symptomatic relief following MFS. The median Venous Clinical
Severity Score (VCSS) decreased from 12.5 preoperatively
to 10 postoperatively. The closure rate at last follow-up
was 96%, and the absolute ulcer healing rate in this study
cohort was 64%. One popliteal vein thrombus extension
developed and resolved with oral anticoagulation. One
asymptomatic gastrocnemius vein DVT resolved without
treatment. No pulmonary emboli or adverse neurologic
events occurred.
Kim and colleagues also reported excellent results
following MFS treatment of supercial vein reux in 60
patients.
12
The postoperative closure rate at 6 months was
93%, and VCSS scores improved signicantly following
treatment (7.3–1.4). The incidence of postoperative DVT
was low (1.7%). The most common adverse reactions
included supercial thrombophlebitis (8.3%) and skin
pigmentation (6.6%). In a recent study, Deak treated 250
patients over a 2-year period with polidocanol MF and
reported similar clinical outcomes.
of valvular reux and symptomatic improvement occurred
in 94% of patients. Two asymptomatic DVTs and one common femoral vein thrombus extension were reported. The
ulcer healing rate in this study cohort was 80% with no
other serious complications reported.
10
In a recent publication,
13
Complete elimination
11
38.7 Optimal patient selection and clinical experience with MFS 391
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38.6 RESULTS: COMPARISON WITH
OTHER TREATMENT MODALITIES
Compared with RFA and laser ablation of the saphenous veins, MFS does not require injection of perivenous
tumescent anesthesia prior to vein closure. This can be
a source of increased pain and discomfort in patients
undergoing thermal ablation because multiple subcutaneous injections are usually required. Additionally, because
MFS is nonthermal, there is no risk of heat-induced nerve
injury, which can be a source of persistent, postoperative
neuropathic pain.
Despite these clinical advantages associated with MF,
formal published comparisons between MFS and thermal
ablation are currently sparse. Based on the most recent
clinical practice guidelines from the Society for Vascular
Surgery and the American Venous Forum, there is insufcient high-quality evidence to recommend MFS over
current thermal techniques for primary saphenous vein
closure.
new technology that can be added to the “armamentarium”
of the existing thermal techniques used by venous specialists to treat saphenous vein insufciency. Another study by
Deak recently compared outcomes following endovenous
laser ablation (EVLA) and 1% MFS in a cohort of 1070
patients with follow-up of 57 months.
nation of reux was similar in both groups (MF 93.5%,
EVLA 92.8%). The incidence of postoperative ATEs was
low in both groups. Of note, closure rates in both groups
were maintained 36 months following saphenous vein closure.
RFA for both above-knee GSV and AASV.
200 consecutive limbs underwent closure of the aboveknee GSV and AASV over a 3-year period. Complete
closure occurred in 100% of patients following RFA
and 90% following MFS. Eight veins (8%) in the MFS
group partially closed. Median VCSS scores improved
signicantly following both treatments (RFA 9.4–7.3,
MFS 9.6–7.8). The incidence of symptomatic supercial
thrombophlebitis was higher in the MFS group (MFS
15% vs RFA 6%). Proximal deep venous thrombus
extension and remote DVTs were slightly higher in the
MFS group, but these differences did not reach statistical
signicance. All ATEs resolved with short-term oral anticoagulation.
pared with RFA, is safe and effective in patients with
large-diameter (LD) (>8 mm) truncal veins with symptomatic reux.
truncal veins (RFA n = 66, MFS N = 66) and associated
tributary veins between 2018 and 2022. The mean truncal
vein diameter treated was 10.5 mm (RFA, 10.0 mm, MFS
10.9 mm). Early closure rates were 100% and 95% in the
RFA and MFA groups, respectively. Operative times were
signicantly shorter in the MFS group (RFA 55.7 min,
14
Early comparisons indicate that MFS is a promising
15
Successful elimi-
We recently compared outcomes between MFS and
Our clinical experience also indicates that MFS, com-
17
We treated 132 consecutive limbs with LD
16
In this study,
MFS 31.6 min). VCSS improved in both groups. In the RFA
and MFA groups, 83% and 79% of venous ulcers healed
during the study period. Symptomatic supercial phlebitis occurred following RFA in 11% and following MFA in
17%. The incidence of postablation PDVTE was 3.0% in
the RFA group and 6.1% in the MFA group, which was
not statistically signicant. All resolved with short-term
oral anticoagulant therapy. No remote DVTs or pulmonary
emboli (PE) occurred in either group.
38.7 OPTIMAL PATIENT SELECTION AND
CLINICAL EXPERIENCE WITH MFS
Prior to 2018, venous specialists mostly utilized RFA ablation for primary closure of reuxing supercial truncal
veins in patients with symptomatic venous disease. The
addition of MFS has demonstrated utility and enhanced
clinical outcomes across a wider array of clinical scenarios. Our ambulatory venous practice is associated with a
large, academic, tertiary care hospital. Thus, our patient
population is composed of a large percentage of patients
with advanced chronic venous insufciency (CEAP 4–6).
We have demonstrated superior early closure rates, overall
symptomatic relief, and low complication rates with MFS
even in patients with very severe venous disease. Injection
of MF into reuxing truncal and tributary veins (with
proximity to below-knee venous ulcer beds) allows more
complete elimination of reux in anatomic areas where
RFA and stab phlebectomy are not ideal.
All MFS procedures in our venous practice are performed under local anesthesia with selected patients also
receiving oral sedation (diazepam 5 mg). As mentioned,
MFS is associated with minimal patient discomfort without the need of tumescent anesthesia. Following subcutaneous injection of local anesthesia for sheath placement,
MFS is relatively painless, and operative times have been
signicantly shorter than RFA in our clinical experience.
Thus, MFS is an excellent treatment option in anxious
patients in the ambulatory setting who would otherwise
require higher levels of sedation for RFA.
The current literature and our anecdotal experience
demonstrate that DVT and PDVTE occur infrequently following MFS. However, it remains difcult to predict which
patients with postoperative ATEs will develop worsened
clinical complications traditionally associated with DVT
(i.e., edema, thrombus extension, PE). We have previously
published a classication system for proximal endovenous
closure levels and an algorithm for selective anticoagulation following RFA of the saphenous veins.
adopted this same surveillance and treatment protocol
following truncal vein MFS. We obtain a complete venous
duplex ultrasound of the treated limb 48–72 hours following MFS. The decision to start oral anticoagulation is made
on a case-by-case basis and determined by patient symptoms and extent of venous thrombus present in the deep
system.
17
We have
16
38
392 Chapter 38 Endovenous MFS for ablation of superficial truncal veins and varicose tributaries
https://t.me/med1917
38.8 CONCLUSION
MFS is a valuable, nonthermal, nontumescent alternative
for the treatment of symptomatic truncal and tributary
vein reux. The short-term clinical efcacy and safety of
this technique compared to placebo have been demonstrated by level 1 randomized evidence, and further studies
demonstrate excellent early outcomes in a wide variety of
clinical scenarios and anatomic locations. Although infrequent, DVT and PDVTE do occur following MFS, and we
continue to advocate postoperative ultrasound surveillance
and selective anticoagulation when they occur. Long-term
prospective studies comparing MFS with existing techniques
are required to conrm its durability and long-term efcacy.
Guidelines and Consensus Statements 38.0 of the American Venous Forum on endovenous microfoam sclerotherapy
for ablation of supercial truncal veins and varicose tributaries
No. Guidelines Grade of
recommendation
38.1 For patients with symptomatic axial reux of the GSV, we recommend either thermal
or nonthermal ablation from the groin to below the knee, depending on the available
1
(strong)
expertise of the treating physician and the preference of the patient.
38.2 For patients with symptomatic axial reux of the SSV, we recommend either thermal or
nonthermal ablation from the knee to the upper or mid-calf, depending on the available
1
(strong)
expertise of the treating physician and the preference of the patient.
38.3 For patients with symptomatic axial reux of the AAGSV or PAGSV, we suggest either
thermal or nonthermal ablation, with additional phlebectomy, if needed, depending on
2
(weak)
the available expertise of the treating physician and the preference of the patient.
38.4 For treatment of symptomatic varicose tributaries, we recommend mini-phlebectomy
or ultrasound-guided sclerotherapy using physician-compounded foam (PCF) or poli-
1
(strong)
docanol endovenous microfoam (PEM).
38.5 For treatment of symptomatic varicose tributaries, we suggest transilluminated powered phlebectomy as an alternative treatment for patients with clusters of varicosities
2
(weak)
by a physician who is trained in the procedure.
Consensus Statements
38.6 For patients with symptomatic varicose tributaries, treatment of the tributaries should be performed even if the supercial
trunks are competent.
38.7 There is no clinical evidence that foam sclerotherapy using room air is less safe and effective than using CO
38.8 There is currently no clinical study of sclerotherapy with PCF prepared using the Tessari method that shows that it is less safe
or effective than PEM.
Quality of
evidence
B
(moderate)
C
(low to very
low)
C
(low to very
low)
B
(moderate)
C
(low to very
low)
gas mixture.
2
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