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374 Chapter 37 PCF sclerotherapy for ablation of superficial truncal veins and varicose tributaries
https://t.me/med1917
37.5 The target small saphenous vein is measured here (internal diameter, patient standing) before treatment to select the concen-
tration of sclerosant.
TABLE 37.1 Suggested foam concentrations by the European guidelines for sclerotherapy (14)
Abbreviations: Foam concentrations below 1% are off-label in many countries.
most suitable and safest injection site (DUS in B mode
and color)
2. Disinfection of the puncture zone, probe protection
3. Preparation of the sclerosing foam (1 + 4 sclerosant–air
mixture with two-way connector or three-way tap)
4. Ultrasound-guided puncture and ultrasound verication
of correct positioning of the needle in the vein
5. Injection of a small quantity of foam into the vein to
conrm the endovenous position (B mode) (Figure
37.8)
6. Injection of the required amount of foam while continuing to monitor the target vein by ultrasound (B mode)
7. Postinjection ultrasound check to assess the immediate
impact of the foam injection (B mode) (Figure 37.9)
37.5 Treatment tactics and technique 375
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37.6 UGFS of the GSV; the rst injection is done at the proximal part of the thigh. The two hands are acting independently but in a
coordinated manner. DUS monitoring is constant.
37
37.7 UGFS of an SSV by direct puncture in the proximal third of the calf or mid-calf. See the stabilization of both hands by contact
(even “minimal,” here with little nger for right hand) with the leg.
Depending on the lling and spasm of the target vein, the
practitioner decides whether a complementary injection is
required. In general, one or two injections of 2.5 mL of foam
are required for a saphenous vein, with the total volume of
foam injected for a GSV averaging 4–5 mL and around 3 mL
for an SSV.
7,15,21
However, larger volumes may be required
for a large GSV or for some recurrences in the saphenous
vein territory. The concentrations vary from 1%–3% (POL
or STS) depending on the diameter of the target saphenous
trunk segment, previously measured in the standing position
(see earlier).
caliber (<6 mm), 1% concentration could be sufcient, but
7,16,19
For saphenous trunks of small or medium
376 Chapter 37 PCF sclerotherapy for ablation of superficial truncal veins and varicose tributaries
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37.8 First “drops” of foam to ensure intravenous injection.
37.9 Ultrasound check to assess the immediate impact of the foam injection; note the venous spasm.
2% or 3% concentrations are probably preferable for larger
calibers to enhance the efcacy of FS.
ies are not injected initially.
One or two sessions are generally sufcient to occlude
a saphenous trunk,
tial collapse of the tributaries. Additional treatment with
UGFS or visual sclerotherapy is required for the tributaries,
depending on the extent of varicosities.
The direct puncture UGFS of the tributary VVs involves
the technical modalities mentioned earlier.
15,21,23
Varicose tributar-
7,15,21
which also allows at least par-
37.5.2.1.2 Visual sclerotherapy by direct puncture
Used for visible or at least palpable varicose tributaries.
The equipment used for injection is usually a 26-gauge
(12-mm length) needle tted directly onto the 2.5- or
3-mL low-silicone syringe containing the foam. The foam
is made at the bedside, at the last minute, as described
earlier (1 + 4 sclerosant–air mixture). The dominant hand
punctures the vein and carries out the injection, while
the other hand assists; for example, the other hand may
stretch the skin between the thumb and middle nger to
37.5 Treatment tactics and technique 377
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37.10 Visual sclerotherapy. The dominant hand handles the syringe while the other hand stretches the skin.
37
facilitate the puncture or touch the skin near the injection
site to detect any extravasation of the product during the
injection (Figure 37.10).
The concentrations and volumes of foam injected vary
according to the diameter of the varicose veins and the
extent of varicosity. However, a concentration of 1% (POL
or STS) is often sufcient, and routinely, foam volumes
should not exceed 10 mL per session.
tration may also be suitable for sclerotherapy of tributary
VVs, but it is off-label in foam form in most countries.
14
The 0.5% concen-
37.5.2.1.3 Tips and tricks for direct puncture
The direct puncture UGFS technique is quite demanding and needs training. It requires good practice in DUS,
dexterity to hold the ultrasound probe with one hand
and manipulate the syringe with the other, good cerebral
coordination of both hands, and a certain speed, because
ideally the foam should not be injected more than 1 minute
after it has been prepared. Managing the 2D image seen
on the screen to successfully direct the needle and reach
the venous target in a 3D space is another difculty to
overcome (Figures 37.11–37.13). A few tips and tricks can
17,19
help.
The practitioner and the patient must be comfortably
positioned, with the patient placed in such a way as to facilitate access to the puncture site as much as possible. Before
carrying out the procedure, the practitioner can rst simulate the UGFS to ensure that the position chosen is appropriate (ask the patient to lie on his or her side if necessary, so
that the probe lies at against the skin) and that the access
site allows the syringe to be handled easily. To stabilize the
hands during the gesture, the dominant hand should keep
tactile contact with the leg as much as possible, even minimally with the little nger, for example, and the transducer is
held low enough by the second hand that it is also in contact
with the leg (Figure 37.9). The practitioner can also make a
marking on the skin to better locate the veins.
Ultrasound monitoring is constant throughout the procedure. Commonly, the most used sections for ultrasound
guidance are longitudinal and transverse (or “cross”),
although there are intermediate sections. If the ultrasound
probe is positioned on the skin in the same direction as the
target vein, i.e., parallel to the vein, the section is said to be
longitudinal. If it is applied perpendicular to the vein, the
section is said to be transverse (Figures 37.11–13).
The longitudinal section offers the best view but is more
difcult to produce and presents a risk of parallax error.
The role of the second hand is of paramount importance
to avoid parallax error, because the target image must be
“perfect.” Indeed, the rst requirement is that the ultrasound probe must be positioned to obtain the best possible
image of the lumen of the target venous segment. This lumen
must be as dark and uniform as possible, with no artefacts.
Then the probe must be held gently in this position without
crushing the vein. Using the dominant hand, the puncture
is made, taking care to align the syringe–needle axis with
the axis of the probe in longitudinal section. It should be
kept in mind that the ultrasound beam is much narrower
than the probe and only 1 mm thick (not thicker than a
credit card); the needle must therefore be well centered to
be in the beam; otherwise, it will not appear on the screen
(Figure 37.12). For the puncture, the inclination of the needle in relation to the plane of the skin varies between 30°
and 45° but may be greater depending on the thickness of
the tissue to be penetrated.
puncture and aims at the target (lumen of the vein), while
the other hand must maintain a perfect ultrasound image of
this target, without moving. As soon as the needle appears
on the screen, its direction is corrected if necessary and it
The dominant hand makes the
378 Chapter 37 PCF sclerotherapy for ablation of superficial truncal veins and varicose tributaries
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37.11 Longitudinal section. The transducer is parallel to the vein axis.
37.12 Longitudinal section. The ultrasound beam is very narrow (in red), and the needle must be within the beam to be visible on
the screen of the DUS machine.
37.13 Transverse (or cross) section. The transducer is perpendicular to the vein. The needle can more easily reach the beam but
must not transx the posterior wall of the vein.
37.5 Treatment tactics and technique 379
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is progressively advanced under the transducer toward the
vein, then it transxes the anterior wall of the vein to reach
the center of the vein (the passage is felt by the hand). Note
that if the needle is fully inserted but still not visible on the
screen, that means it is not in the beam. In this case, it should
be moved back without being completely withdrawn, and
the needle–syringe axis should be correctly aligned with the
probe axis before moving it forward again. During injection,
the progression of the foam is clearly visible, is linear, and
should be fully monitored on the screen.
For the transverse section, only the tip of the needle is
visible, like a dot on the screen, and has a different echogenicity. It must therefore be carefully located to ensure
that it is positioned correctly in the vein lumen and does
not transx the posterior wall of the vein, in which case it
would be extravascular.
37.5.2.2 Cannulae
With the aim of introducing “fresh” microfoam at 10- to
20-cm intervals along the trunk and major tributary VVs
to be treated, intravenous cannulas are placed at strategic points under local anesthetic and ultrasound guidance
with the patient in the supine and/or prone position. The
size of cannulae to be used is determined by vein diameter
and depth. In a patient with “standard” GSV varicosities,
four cannulae are typically positioned in the GSV as follows:
10–15 cm below the SFJ, just above the knee, just below
the knee, and just above the ankle. In general, the greater
the diameter of the GSV, the closer the cannulae are placed.
Where present, cannulae will also be placed in the AASV and
in all the major tributaries. If there are extensive supercial
varices, typically in the calf, then these too will be cannulated. In a patient with “standard” SSV varicosities, the SSV
is typically cannulated just distal to the SPJ, with the cannula
pointing caudally to minimize entry of foam into the popliteal vein, and again in the distal SSV usually just above the
ankle or at the point of the distal incompetence The leg is
then elevated to 45 degrees in a sling to empty the supercial veins. The placement of cannulae allows the varicose
veins to be completely emptied of blood (so increasing the
efcacy of the sclerosant) and virtually excludes the risk of
extravasation. Microfoam aliquots (typically 2–3 mL, 1 + 4
gas-to-sclerosant mix) are then injected via the cannulae,
usually moving from proximal to distal. Typically, we use
3% STS for truncal veins, 1% STS for major tributaries, and
0.5%–1% STS for minor tributaries and supercial varices
or very supercial truncal veins. The foam is injected slowly
under direct ultrasound to minimize venospasm and minimize entry of foam into the deep system. For larger truncal
veins, we often perform a second injection in the proximal
one or two truncal cannulae. The microfoam can be “milked”
along the trunk and into tributaries and varices using the
ultrasound probe. Between injections, the patient is asked to
plantar ex and dorsiex their ankle to expel any foam that
may have migrated into the deep system. The quantity of
foam used depends on the extent of the veins to be treated,
but in our practice, it would be unusual to use more than
16 mL 3% 1 + 4 air microfoam, which equates to 4 mL of
3% STS. Once the trunk, tributary, and varicose veins are in
spasm and full of foam, the cannulas are removed and, while
the leg remains elevated, a cotton wool roll is placed over the
trunk to provide eccentric compression.
37.5.2.3 Catheter-directed FS
Catheter-directed foam sclerotherapy (CDFS) can be used
with or without perisaphenous tumescence inltration,
although an RCT comparing the two options in the treatment of GSV with CDFS showed no superiority or benet
for the tumescence group.
When performing CDFS, sclerosant foam is injected
through a long (30–40 cm) intravenous catheter all along
the saphenous trunk under ultrasound visualization.
A systematic review and meta-analysis of 3689 patients
showed a higher occlusion rate of 82.4% after CDFS and
62.9% after UGFS (p < 0.001) at 3 years follow-up.
ever, there is considerable heterogeneity of practice within
each technique, which is a limitation to the analysis of data
from both groups. Moreover, because it requires catheterization, CDFS is less versatile in its indications than direct
puncture, and its use may be hampered by endoluminal
obstructions or tortuosities.
In summary, many techniques are used for FS, and there
is little evidence to date of the superiority of one method
over another. Practitioners should use the technique with
which they are most comfortable and for which they have
been trained, and they should always ensure that the procedure is safe. Whatever the technique used, including
CDFS, ultrasound monitoring is essential and mandatory
for sclerotherapy of the saphenous vein to avoid any risk
of intra-arterial injection.
24
25
26
How-
27
37.5.3 Maneuvers and related practices
Regardless of the FS technique used, manual compression
of the saphenofemoral and saphenopopliteal junctions (e.g.,
using direct pressure from the ultrasound probe) to prevent
foam migration into the femoral and popliteal veins is not
recommended.
could even be counterproductive by allowing a sudden
“bolus” of foam trapped in the GSV/SSV to enter the deep
veins. For safety reasons, direct treatment of perforators
with FS is not recommended due to the constant presence
of arteries accompanying the perforators. In fact, occlusion
of the trunks by foam is generally sufcient to neutralize
directly connected perforators. For varicose veins related
to perforators, the treatment will consist of treating these
varicose veins and not the perforators directly.
Historically, there have been two different approaches
to postprocedure compression. According to the French
Tournay school, compression is not used after sclerotherapy,
whereas for the Swiss and Irish schools, it is indispensable.
The arguments of the proponents of post-sclerotherapy
compression do not seem clear. Do they want to increase the
efcacy of sclerotherapy and/or reduce side effects? To date,
no study has clearly demonstrated a benet in either area.
It has even been demonstrated that only compression >60
mmHg can reduce the diameter of the saphenous vein (29).
We do not use systematic compression for endovenous
treatments of saphenous trunks or varicose veins of any kind.
We only recommend compression to symptomatic patients
14,28
This practice has not proved useful and
37
380 Chapter 37 PCF sclerotherapy for ablation of superficial truncal veins and varicose tributaries
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with CEAP class 2–6 disease. In a randomized controlled trial
(RCT), we compared compression stockings (15–20 mmHg)
worn during the day for 3 weeks after UGFS of the saphenous trunks with no compression and found no difference in
occlusion rates, side effects (thrombophlebitis, inammation,
pain, and pigmentation), satisfaction scores, and improvement in health-related quality of life (HRQOL).
30
Among proponents of postprocedure compression,
there is a wide range of views regarding the type and duration of compression. An RCT compared bandaging for 24
hours and 5 days, both followed by a thromboembolic-deterrent stocking for the remainder of 2 weeks and reported
no advantage of prolonged compression bandaging in
terms of phlebitis, skin discoloration, postprocedural pain,
improvement in HRQL, and 6-week target vein occlusion
31
rates.
The 2013 National Institute for Health and Clinical
Excellence (NICE) guidelines on varicose veins could not
provide guidance other than to state a limit on the number
of days compression bandaging or hosiery is prescribed for,
when offered.
32
We have a wide variety of endovenous techniques to
treat varicose veins, and these can be combined so that
the overall treatment is tailored to the individual patient’s
needs, expectations, and desires. UGFS is particularly
appropriate for complex recurrent disease associated with
neovascularization, where the varicose veins to be treated
are often too small, tortuous, and supercial to be treated
easily by means of endothermal ablation (ETA) and where
the versatility and adaptability of FS are major advantages.
37.6 RESULTS OF FS
In 2003, we demonstrated in an RCT that the efcacy of
foam for treating GSV was twice that of liquid for the same
volumes injected but with ve times less sclerosing agent
for foam.
foam (74 patients in each group), we found similar rates
of absence of reux at 2 years for both concentrations for
treatment of incompetent medium-caliber GSV (4–8 mm).
These results are in line with two other RCTs.
was double-blind, and we also found that after 2 years,
when the blind was lifted, in 71% of the cases the investigators had failed to identify the concentration they had
used. In 50% of cases the answer had been “no idea,” and
in 21% of cases the answer was wrong. This reects the
fact that 1% and 3% foam are similar in aspect. On ultrasound, retraction of the occluded GSV began at 6 months,
and its disappearance or transformation into a cord image
could take as long as 2 years. We compared side effects after
sclerotherapy in thrombophilic patients.
patients were selected: 75 with factor V Leiden mutation,
18 with prothrombin 20210A mutation, 7 with high levels
of factor VIII, and 5 with combinations of these. After randomization, 51 and 54 patients, respectively, received warfarin (1 mg/day starting 10 days before the sclerotherapy
session and continuing for 4 weeks) and LMWH (a single
dose of 4000 IU nadroparin on the day of sclerotherapy). A
total of 199 sclerotherapy sessions were performed. Foam
4
In 2007, in an RCT comparing 1% and 3% POL
22,23
Our RCT
33
A total of 105
15
was used in 160 treatments. No thromboembolic events
occurred, suggesting that sclerotherapy may be safe in
nonsevere thrombophilias with minimal pharmacological
thromboprophylaxis; however, further clinical studies are
required. In a subgroup of our “compression-RCT,” we
studied biological markers of coagulation and inammation after UGFS of the saphenous veins, with or without
compression (20 patients in each group).
30,34
The studied
markers were soluble thrombomodulin (TM), platelet factor 4 (PF4), thrombin–antithrombin complex (TAT), D-dimers, brinogen, factor VIII (FVIII), and troponin. During
the study, ve blood samples per patient were taken systematically, respectively, on Day 0 (just prior to sclerotherapy)
representing the baseline, Day 1 (D1), D7, D14, and D28.
Apart from a moderate D-dimer increase at D1–D14, no
signicant biological change was observed in either with or
without compression groups.
In the DIAGRAVES study of the French Society of Phle-
35
bology,
1245 patients (C0s–C6 disease) of 35 vascular
physicians were studied. Sixty percent of the limbs had
reux in the GSV, more than half of the incompetent GSVs
had a diameter <6 mm. The average diameter was 5.6 +/– 2
mm, and the distributions were 62% <6 mm, 30% between
6 and 8 mm, and 8% >8 mm. Several studies have shown
that foam is more effective on diameters <6 mm.
should be kept in mind when considering FS in patients
with varicose veins.
Published observational case series attest to the safety
and clinical efcacy of UGFS, with rates of occlusion about
90% at 1–5 years. RCTs comparing UGFS with conventional surgery showed similar efcacy, and Kalodiki et
al., at 3 and 5 years, also found similar improvements in
venous clinical severity scores and HRQL (SF-36 and Aberdeen Varicose Vein Score).
38
When compared to thermal ablation, UGFS showed
lower long-term occlusion rates but highly signicant and
broadly similar improvements in patient-reported outcome
measures. The FOVELASS RCT included 3-year results
of 11 centers, comparing FS with endovenous laser ablation (1470 nm EVLA) for treatment of the SSV.
trial of the French Society of Phlebology, 82 patients were
included in the FS group and 79 in the EVLA group; 86%
of patients completed the 3-year study. Short-term absence
of reux (primary endpoint) was high and equivalent for
both groups, but at 3 years, partial and total failure rates
were 11% and 3% after EVLA, respectively, and 26% and
17% after FS, respectively. However, residual varicose vein
rates decreased and were equivalent in both groups, and the
rVCSS, the HRQL (CIVIQ score), and symptom questionnaire scores improved signicantly and similarly after both
treatments at 3 years. Median patient satisfaction scores at
3 years were high in both groups. In the FS group, in case
of failure, the mean SSV diameter was 2 mm at 3 years for
an initial diameter before treatment of 6 mm. This is in line
with data from the RCT “1 versus 3,” where the mean diameter of recanalized GSV at 2 years was 2.8 mm for an initial mean diameter of 6 mm.
15
This could explain the good
clinical results of foam compared to technical results, since
even in cases of technical failure, the saphenous vein is much
36,37
This
7
In this
37.7 Indications, contraindications, and side effects 381
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TABLE 37.2 Comparison of technical success at 5 years for EVLA versus UGFS
Source: (Whing et al. Cochrane Database of Systematic Reviews 2021, Issue 8. Art. No.: CD005624, with permission[39].)
37
smaller after treatment in many cases. One question remains
unanswered: Which outcome is more important, technical
success or clinical success? The Cochrane review of 11 RCTs
of interventions for GSV incompetence demonstrated that
EVLA and high ligation and stripping (HL&S) may offer
improved technical success compared to UGFS (Table 37.2),
but there was no difference in recurrence, and the quality-of-life improvements were comparable between interventions (moderate-certainty evidence). Future trials should
standardize the clinical terminology of outcome measures
and the time points at which they are measured.
The FOVELASS study also addressed the issue of concomitant treatment of tributaries. Treatment of tributaries
(phlebectomies or sclerotherapy) was only allowed from 6
months after trunk treatment. In total, 15 patients (19%)
received tributary treatment only by sclerotherapy, at an
average of 1.2 sessions per patient in the EVLA group, compared with 27 patients (33%), at an average of 1.5 sessions
per patient in the FS group. In 81% of the EVLA patients
and in 67% of the FS patients, treatment of tributaries was
not necessary. Sclerotherapy was carried out during scheduled follow-up visits. This reinforces the need for shared
decision making with the patient about simultaneous or
delayed treatment of tributaries, as emphasized in recent
international guidelines.
40,41
39
used to treat the other varicose veins or recurrences of the
saphenous veins.
FS is challenged today for saphenous ablation, especially if the diameter is >6 mm, but the saphenous veins
may be pathologic in only 30%–50% of varicose veins of
the lower limbs.
C0s–C6 patients had saphenous reux.
Consequently, if we add up all nonsaphenous veins (the
lower limb varicose veins of pelvic origin, perforating veins,
marginal and sciatic nerve varicose veins, etc.), tributaries,
recurrences, venous plexus of leg ulcers, and varicose veins
at risk for bleeding, but also reticular veins, telangiectasias,
venous malformations, and noncatheterizable saphenous
trunks (due to tortuosities or endoluminal obstructions),
the eld left for sclerotherapy is huge, and there is great
demand to master sclerotherapy.
Contraindications to sclerotherapy:
• Known allergy to the sclerosant
• Acute deep vein thrombosis and/or pulmonary embo-
lism thrombosis (less than 3 months)
Severe acute systemic illness or infection
•
• Local infection in the area of sclerotherapy
• Long-lasting immobility and connement to bed
• Severe neurological or cardiac adverse events (AEs)
complicating a previous sclerotherapy treatment
42
In the DIAGRAVES study only 40% of
35
14,43
37.7 INDICATIONS,
CONTRAINDICATIONS,
AND SIDE EFFECTS
Of all the methods available to treat varicose veins, FS is
the most versatile and can technically be performed for all
types of varicose veins. Most other methods, on the other
hand, focus on the saphenous trunks, and they are rarely
For FS, in addition:
Known symptomatic right-to-left shunt (e.g., symptom-
•
atic patent foramen ovale)
Relative contraindications (individual benet–risk assessment mandatory):
Pregnancy, postpartum, and breastfeeding (interrupt
•
breastfeeding for 2–3 days)
382 Chapter 37 PCF sclerotherapy for ablation of superficial truncal veins and varicose tributaries
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• Severe peripheral arterial occlusive disease
• Poor general health
• Strong predisposition to allergies
• High thromboembolic risk (e.g., history of thromboem-
bolic events, known severe thrombophilia, hypercoagulable state, and active cancer)
Acute supercial venous thrombosis (less than 6 weeks)
•
• Risk of cardiac AEs, in particular, a family history of
sudden death in a rst-degree relative
Tamoxifen therapy in the rst 2 years
•
For FS, in addition:
Risk of neurological AEs
•
• Neurological disturbances, including migraine, follow-
ing previous FS
The most common side effects of FS are lumpiness, localized phlebitis, and skin staining in association with excessive intraluminal thrombosis, which tends to occur most
often within large or supercial varicose veins. These side
effects can be mitigated by good technique, early ultrasound-guided aspiration, and strong patient reassurance.
Serious complications are very rare. In a series of 1605
patients treated with FS, the French POL study reported
only eight (0.5%) calf vein thromboses.
44
In a multicenter
study of 1025 patients, Gillet et al. reported only ten (1%)
patients (ve symptomatic) with DVT and one with a pulmonary embolism.
a study of 213 FS treatments.
45
There were no DVTs and one PE in
46
Visual disturbances (VDs)
comprising unilateral/bilateral blurred vision, double
vision, and scotoma have been reported in 0.09%–4.5%
of patients undergoing FS.
47
The results of a French study
showed that VDs occurring after FS correspond to migraine
with aura, and they are not transient ischemic cerebrovascular events. The authors suggest endothelin release reaching the cerebral cortex via a foramen ovale as a possible
mechanism.
48
Other neurological symptoms are extremely
rare. A review of 10,819 patients identied 15 transient
ischemic attacks and 12 cerebrovascular accidents, with
one fatality. Two patients had residual weakness; 11 transient ischemic attacks/cerebrovascular accidents were
associated with a patent foramen ovale.
49
Symptoms often
occurred minutes to hours after FS, and the longest was
delayed to 5 days. The cause of these neurological symptoms are foam bubbles passing into the cerebral circulation
in at least some cases.
such as endothelin may also play a role.
have been reported after CS and thermal ablation proce-
52,53
dures,
which suggests that at least some are coinciden-
50
Release of vasoactive substances
51
Similar AEs
tal and unrelated to the FS.
In a prospective study of 8056 FS treatments using STS
1% and 3% physician-generated foam, 46 patients had
AEs, for an overall incidence of 0.57%.
54
Twenty-six had
a migraine/headache with or without a VD; 21 (80.8%) of
these had a history of migraine. Twelve other patients had
VDs without migraine/headache, of which 4 had a history
of migraine. Ten patients received a volume of foam signicantly higher than the recommended maximum dose
of 16 mL. There were ve serious AEs (0.062%), one anaphylaxis and four neurological events (0.049%); three of
these resolved, leaving long-term sequalae in one patient
(0.012%). This patient developed left-sided weakness and
facial droop after treatment with 32 mL 1% STS foam for
residual varicosities. She had CT evidence of air embolus
in the right middle cerebral artery. The patient was treated
with hyperbaric oxygen therapy and made an almost complete recovery. There was no mortality. This study suggests
that history of migraines and excessive volumes of foam are
risk factors of neurological events. Myocardial infarction,
likely due to bubbles passing through a patent foramen
ovale into the coronary circulation, was also reported.
Inadvertent intra-arterial injection has been reported
63 times and led to amputation in 31 patients.
55
56
In some
of these cases, good practices were not followed, particularly with choosing the injection sites and using DUS for
pretreatment identication, procedure guidance, and monitoring of sclerosant distribution.
A 2022 analysis of AEs reported to the U.S. FDA found
that lethal risks of sclerotherapy do exist, although they
are extremely rare and tend to be cardiac (heart rhythm
disorder) with POL and anaphylactic with STS. POL had
the most AEs, but is also the most popular sclerosant, with
the lowest ratio of serious AEs to total cases.
57
The study
suggested that patients receive a list of serious and common AEs as part of the informed consent before FS.
Better standardization and uniformity of certain safety
criteria are also expected from drug agencies. For example, the total volume authorized for foam differs from one
European country to another and may even differ within
the same country depending on whether the sclerosant
is STS or POL (from 10 mL/session to 16 mL/session).
Varithena is licensed in the United States for volumes of up
to 15 mL/treatment session.
The concentrations used for foam should also be better standardized. Some guidelines have been published,
but unfortunately the use of foam at concentrations
below 1% is not permitted today, which is a limitation
(Table 37.1).
Finally, it is also necessary to develop appropriate theoretical and practical initial and continuing training to
ensure that good practice is followed.
37.8 CONCLUSION
FS is a widely applicable and highly versatile, clinically effective, and cost-effective treatment for primary and recurrent
VVs that can be safely performed in an ofce setting and
is well-tolerated by patients. Its place is evolving under the
impetus of new techniques designed primarily to treat saphenous veins; nevertheless, its role is and should remain essential for many years to come in many situations. Its teaching
needs to be reinforced to optimize its efcacy and safety.
References 383
https://t.me/med1917
Guidelines and Consensus Statements 37.0 of the American Venous Forum on physician-compounded foam (PCF)
sclerotherapy*
No. Guidelines Grade of
recommendation
37.1 For patients with symptomatic axial reux of the GSV, we recommend either
thermal or nonthermal ablation from the groin to below the knee, depending
1
(strong)
on the available expertise of the treating physician and the preference of the
patient.
37.2 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, de-
1
(strong)
pending on the available expertise of the treating physician and the preference of the patient.
37.3 For patients with symptomatic axial reux of the AAGSV or PAGSV, we
suggest either thermal or nonthermal ablation, with additional phlebectomy,
2
(weak)
if needed, depending on the available expertise of the treating physician and
the preference of the patient.
37.4 For treatment of symptomatic varicose tributaries, we recommend mini-phlebectomy or ultrasound-guided sclerotherapy using physician-compounded
1
(strong)
foam (PCF) or polidocanol endovenous microfoam (PEM).
37.5 For treatment of symptomatic varicose tributaries, we suggest transilluminated powered phlebectomy as an alternative treatment for patients with
2
(weak)
clusters of varicosities by a physician who is trained in the procedure.
Consensus Statements
37.6 For patients with symptomatic varicose tributaries, treatment of the tributaries should be performed even if the supercial
trunks are competent.
37.7 There is no clinical evidence that foam sclerotherapy using room air is less safe and effective than using CO
37.8 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
37
* Based on Ref. 40.
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