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199
15
Foam Treatment of
Venous Leg Ulcers: The
Initial Experience
Juan Cabrera and Pedro Redondo
INTRODUCTION
Venous leg ulceration is a widespread and debilitating chronic condition.
It is most commonly observed in the elderly but can also affect young
adults. It is characterized by slow healing, pain, and frequent ulcer recur-
rence. The pain is characteristically worse at night, limits mobility and
leisure activities, and disturbs sleep. Bandages and dressings are often
malodorous, contributing to the depression and social isolation that can be
experienced by sufferers. Most patients describe the pain, which is greater
with larger ulcer size,
1
as the symptom with most impact on their quality
of life. Chronic venous leg ulcers also represent a considerable economic
burden and consume 1% to 2% of health care budgets, comparable with
expenditure on diabetes or stroke.
Venous hypertension (VH) is the underlying cause of venous ulceration
(VU), although the pathogenic steps involved are not fully understood.
The pathophysiology of venous ulcers is centered on a hemodynamic dys-
function that may involve superfi cial, perforator, or deep veins together or
separately and is frequently compounded by immobility. The following
mechanisms have been implicated: dysfunction of valves in superfi cial
and/or perforator veins due to congenital or acquired incompetence; dys-
function of valves in the deep system due to congenital absence or throm-
botic damage; deep venous outfl ow obstruction; and muscle dysfunction
leading to calf muscle pump failure.
2
A number of authors have assessed
the distribution of valvular incompetence in patients with venous ulcers
by means of duplex ultrasound, the state-of-the-art technique in venous
Venous Ulcers
Copyright © 2007 by Academic Press, Inc.
All rights of reproduction in any form reserved.
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200 Foam Treatment of Venous Leg Ulcers: The Initial Experience
diagnosis.
3
Using this approach, a study of 887 limbs with venous ulcers
showed the cause to be isolated superfi cial venous refl ux in 46%, deep
venous incompetence in 5%, and perforators in 2% of cases; multisystem
refl ux or obstruction was found in 44%, and no refl ux was detected in 3%
of ulcers.
4
Therefore, the successful treatment of incompetent superfi cial
and perforating veins could be expected to eliminate VH and thereby
permit ulcer healing, reducing the risk of recurrence by approximately
50%. Unfortunately, it has not been possible to take advantage of this
advance, since an adequate treatment has not been available. Among other
reasons, the explanation is largely that surgery has been the main thera-
peutic approach to incompetent veins, and elderly patients are reluctant to
undergo the operation, while surgeons are reluctant to perform it in the
presence of an ulcer due to the risk of infection. However, access to effec-
tive treatment of ulcerated limbs has recently improved with the advent of
less invasive treatments, including radiofrequency ablation, laser ablation,
and, least invasive of all, microfoam sclerotherapy. This chapter describes
our initial experience using ultrasound-guided microfoam sclerotherapy in
the management of ulcer healing.
TREATMENT OPTIONS
The primary aim of chronic VU treatment is to reverse the effects of
VH. Treatments used to heal open VUs include standard compression
therapy with elastic stockings or bandages, skin grafting, and direct vein
treatment by venous surgery or sclerotherapy. Compression therapy is
recognized as the mainstay of ulcer treatment and prevention, using mul-
tilayer compression bandaging for treatment and compression hosiery for
prevention.
6,7
Simple superfi cial venous surgery by stripping or ligature theoretically
removes the underlying venous incompetence in legs with isolated super-
fi cial venous refl ux. Surgery to correct venous refl ux in the deep veins is
complex and of unproven value.
8–10
Over the past 2 decades, however, the
emergence of minimally invasive surgical techniques has led to debate
about the most appropriate surgical therapy for severe chronic venous
insuffi ciency and venous ulcers. Subfascial endoscopic perforator surgery
(SEPS) has become the surgical technique of choice for perforator abla-
tion.
11
Nevertheless, the effi cacy of perforator ablation remains highly con-
troversial, regardless of the technique used. Postoperative duplex imaging
studies showed that ablative superfi cial venous surgery reversed around
half of the cases of segmental refl ux in deep veins
12
and of refl ux in calf
perforators.
13
Surgical correction of superfi cial refl ux may abolish incom-
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Foam Treatment of Venous Leg Ulcers: The Initial Experience 201
petence in some calf perforators and offer protection against recurrence
of perforator incompetence.
14
Percutaneous ultrasound-guided coil embolization does not appear
to be as effective as SEPS in the treatment of incompetent perforator
veins.
15
FROM CLASSIC SCLEROTHERAPY TO
MICROFOAM SCLEROTHERAPY
Liquid sclerotherapy represented a useful complementary therapeutic
model in the treatment of VU. In 1990, Queral et al. demonstrated it to be
an effi cacious adjuvant to unna’s boot in the treatment of VU.
16
Sclero-
therapy with ligation of incompetent veins was found to be a safe and
effective treatment of VU, with the combined procedure achieving an
improvement in venous hemodynamics and subjective symptoms compa-
rable to that obtained by high ligation and stripping.
17
In 2000, Guex
18
reported his experience with direct perforator treatment under ultrasound
guidance. The sclerosing agent used was Sotradecol (3%) or Polidocanol
(3%) for veins >4 mm and a more dilute solution for veins <4 mm. He
estimated that 90% of perforators could be eliminated after 1–3 injection
sessions. However, liquid sclerotherapy has many limitations.
19
A given
dose of liquid sclerosing agent cannot provide a similar sclerosing action
in all cases, since its intravenous concentration varies according to the
hemodynamic conditions of the injected vessel and is always unknown.
Moreover, contact with the substance is lost after its injection, and little
can be done to direct it or modify its action. This inability to control liquid
agents can sometimes cause undesirable effects in the deep venous system.
Thus, the major drawbacks of liquid sclerosants include a progressive
dilution in the blood, increasing deactivation, irregular distribution on the
venous endothelium, absence of control over the duration of sclero -
sant-endothelium contact, and inadequate volumes at therapeutic dosage.
Moreover, they cannot be manipulated, perceived on duplex, or seen on
ultrasonography after injection. In contrast, microfoam sclerotherapy
offers the following advantages: mechanical action displacing the blood,
greater sclerosing ability and volumes than the liquid form, manageability
or remote control (microfoam has a high degree of internal cohesion that
allows it to be aspirated and re-injected), selectivity of action, stability of
microbubbles, rapid elimination of the gas, and real-time perceptibility on
duplex and visibility on ultrasound,
20–22
Further benefi ts of microfoam
sclerotherapy include the absence of anesthesia and hospitalization, with
no loss of working time by the patient. Indeed, sclerotherapy appears to
be a safer and less costly procedure compared with surgery.
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202 Foam Treatment of Venous Leg Ulcers: The Initial Experience
TECHNIQUE OF MICROFOAM SCLEROTHERAPY
Liquid sclerotherapy had been demonstrated to be a valuable adjunct to
other therapies but has not been widely accepted as primary therapy for
large vein incompetence, which must be treated in most venous ulcers.
Microfoam sclerotherapy pioneered by the principal author has been shown
to be highly effective and safe in the management of incompetent veins of
all sizes in the superfi cial venous system, and he has now applied this
technique to the most severe end of the spectrum of venous disease: leg
ulcers.
Microfoam sclerotherapy is performed in a treatment room without
anesthesia for the nonsurgical elimination of superfi cial refl ux and incom-
petent perforator veins in ulcerated limbs. Duplex ultrasound is used to
identify incompetent vessels and sources of refl ux that cause the VH. After
detailed anatomical mapping, patients are placed in the supine position.
Polidocanol microfoam (15–30 ml) is injected under ultrasound guidance
into the main incompetent vein to fi ll the vein up to the source of refl ux.
23
The access route is variable according to the size of the vein. Cannulation
with an Abbocath 20G cannula is performed in great saphenous veins
(GSVs) or direct needle puncture (23–25G) in smaller veins. Duplex ultra-
sound is used during the procedure to confi rm the correct location of the
needle, the spread of the microfoam, and the onset of vasospasm. The
ultrasound transducer (probe) is placed at the saphenofemoral junction to
show the arrival of the injected microfoam and to occlude the GSV. The
microfoam is then directed distally, replacing the probe with a fi nger to
block the proximal saphenous vein. Perforator veins are selectively treated
by direct ultrasound-guided injection, placing the needle in a superfi cial
vein that is connected to but 2–3 cm distant from the perforator vein. Injec-
tion of Polidocanol microfoam into this area allows control over the volume,
avoiding extension of its action into the deep venous system (DVS). A
volume of 1–4 ml is usually adequate, and digital or transducer compres-
sion is performed to halt any spread of the microfoam toward the DVS.
Another method to protect the DVS is to inject the microfoam with the
limb in elevation (safety angle). This position creates a gradient whereby
the DVS has a higher blood pressure, preventing drainage of microfoam
into the DVS. As a safety measure during injection of leg trunk veins and
perforator veins, advantage is taken of the blocking of intramuscular veins
by calf muscle contraction. Thus, the foot is dorsally fl exed by using the
operator’s hand, or cooperative patients voluntarily sustain contraction of
the medial gastrocnemius muscle. T hese “closed-door” procedures enhance
the safety of the procedure by preventing the microfoam from draining
into the DVS. After the injection, the patient should remain supine for
15–20 minutes before standing up and before application of compression
in order to avoid dislocation of the microfoam column. Treatment is com-
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Foam Treatment of Venous Leg Ulcers: The Initial Experience 203
pleted by placement of pads and application of a compression stocking
(Struva 23-mmHg stocking; MediBayreuth, Barcelona, Spain), which is
worn for 7–15 days after the injection.
RESULTS
During a 115-month period, 116 consecutive patients with VU were
treated by ultrasou nd-guided injection of Polidoc anol microfoam (UIPM) .
23
Their mean age was 57 years (range, 25–85 years). Sclerosis of incompetent
trunk veins was followed at 2–4 weeks by further injections to sclerose
tributaries and residual incompetent perforators under ultrasound guid-
ance. The process was continued until all identifi able incompetence was
eliminated. The number of sessions per patient ranged from 1 to 17 (mean
= 3.6 sessions). Perforators were present in the majority of patients, usually
close to the ulcer. Microfoam was injected into the superfi cial venous
system close to the perforators. Two weeks later, the treated perforator
could be visualized on ultrasound but was not compressible and no fl ow
could be perceived by Doppler examination. Treatment with UIPM
achieved complete healing in 86% of patients at 6 months, with a median
time to healing of 8 weeks; seven patients were never cured and one patient
was lost to follow-up (Figures 15-1 through 15-4). We observed a lower
success rate in ulcers with higher chronicity and in patients with incompe-
tent deep vein system. However, a worse prognosis was associated with
perforator vein versus saphenous vein incompetence. The worst outcomes
were obtained when all three segments were affected (64% of this group
completely healed at 6 months) (Table 15-1).
In comparison with control patients in a previously reported series,
24
we
obtained a signifi cantly better outcome at 6 months in all subgroups except
for patients with ulcers that had been open for >12 years (n = 24). However,
these comparisons probably underestimate the real effectiveness of UIPM,
since they always referred to the percentage of complete healing in the
whole active treatment series
24
and not to the success rate in specifi c sub-
groups with poorer prognosis (Figure 15-5).
In the multivariate Cox model, presence of deep vein incompetence and
high chronicity of the ulcer were identifi ed as independent predictors of
failure to achieve complete healing, although the independent contribution
of the latter variable was small (hazard ratio = 1.02 for each additional year
the ulcer had been open).
There were recurrences in 10 patients. The 24-month recurrence rate
was 6.3% overall and was below 8.5% across all subgroups except for older
patients, patients with deep vein incompetence, and those with ulcers of
largest size or highest chronicity.
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204 Foam Treatment of Venous Leg Ulcers: The Initial Experience
FIGURE 15-1 Extensive ulcer with chronicity of 15 years. Stable long-term outcome.
FIGURE 15-2 Varicose ulcer closure after sclerosing microfoam treatment of proximal
saphenous vein.
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Foam Treatment of Venous Leg Ulcers: The Initial Experience 205
FIGURE 15-3 Stable long-term closure after microfoam sclerotherapy of varicose
saphenous vein and perforator.
FIGURE 15-4 Ulcer closure and signifi cant improvement in periulcerous trophic
disorders after sclerosing microfoam treatment.
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206 Foam Treatment of Venous Leg Ulcers: The Initial Experience
No major complications were noted. No patient had thrombosis of the
femoral-popliteal DVS, pulmonary embolism, or neurological lesions.
Deep vein thrombosis (DVT) has been a concern with this technique.
Before utilization of “closed-door” procedures, fi ve patients developed
DVT in the calf after varicose vein treatment and were managed with
LMW heparin, which achieved recanalization in all patients. There have
been no further cases of calf DVT since the introduction of these safety
maneuvers. Pigmentation was seen in 20% of the patients but was sponta-
TABLE 15 -1 Percentage Completely Healed by 6 Months (Kaplan-Meier Estimates)
Percentage p (vs. Reference Series*)
Overall 86%
<0.001
Gender
Men (n = 39)
81%
<0.001
Women (n = 77)
89%
<0.001
Age
<50 years (n = 35)
90%
<0.001
50–65 years (n = 44)
88%
<0.001
>65 years (n = 37)
80% 0.001
Ulcer chronicity (months)
≤6 months (n = 44)
81%
<0.001
>6 to 12 months (n = 16)
83% 0.002
>12 to 24 months (n = 14)
83% 0.001
>24 to 72 months (n = 18)
86% 0.015
>72 months (n = 24)
66% 0.19
Ulcer area (cm
2
)
≤2 cm
2
(n = 55)
71% 0.001
>2 to <6 cm
2
(n = 24)
88%
<0.001
>6 cm
2
(n = 72)
81%
<0.001
Localization
Exclusively saphenous (n = 34)
90%
<0.001
Exclusively perforator vein (n = 8)
85% 0.14
Exclusively saphenous and perforator (n = 41)
94%
<0.001
Exclusively saphenous and deep vein (n = 11)
85% 0.03
Deep vein ± perforator (n = 13)
79% 0.04
All three segments (n = 11)
64% 0.33
Previous surgery
No (n = 96)
88%
<0.001
Yes (n = 20)
77% 0.06
* Chi-square test using as expected events the results in control patients of the study
by Falanga et al. (Rapid healing of venous ulcers and lack of clinical rejection with an
allogeneic cultured human skin equivalent. Human Skin Equivalent Investigators Group.
Arch Dermatol. 1998;134:293–300), who received only compression therapy and showed
complete healing of 49% at 6 months.
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Foam Treatment of Venous Leg Ulcers: The Initial Experience 207
neously resolved in 90% of them after 6 months. Transient visual distur-
bances (<5 minutes) were observed in two patients.
SPECIFIC CHARACTERISTICS OF MICROFOAM
Sclerosing foam is generally defi ned as a mixture of gas and liquid scle-
rosing solution (detergent type) with tensioactive properties.
25
Besides
being composed of different specifi c ingredients, foams can differ in their
internal cohesion, which is related to the size of the air bubbles. Microfoam
is composed of bubbles smaller than 250 μm.
26,27
The durability of foam is related to the bubble size, the tensioactivity of
the liquid solution, and the conditions under which the foam is formed and
kept. Foam should be suffi ciently durable to avoid its separation into gas
and liquid components during injection but suffi ciently ephemeral to break
down once injected. The gas must be physiologically tolerated at therapeu-
tic doses.
Sclerosant microfoam is composed of microbubbles of oxygen (O
2
) and
carbon dioxide (CO
2
). CO
2
is a nontoxic and highly soluble physiological
gas, and large amounts can be administered. When both gases are mixed
into the surfactant liquid sclerosant, microbubbles of small diameter can be
obtained with suffi cient stability to be injected into the vessels.
28,29
The area of liquid on their surface is enormously increased in inverse
Superficial incompetency and short
duration(n=70)
Deep vein incompetency and short
duration(n=22)
Superficial incompetency and long
duration(n=13)
Deep vein incompetency and
long duration (n=11)
FIGURE 15-5 Cumulative incidence of complete healing according to ulcer chronicity
and to localization of venous incompetence. Kaplan-Meier estimates.
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