Original Article

Phlebology
2024, Vol. 0(0) 1–8
High intensity focused ultrasound in treating © The Author(s) 2024
Article reuse guidelines:
great saphenous vein incompetence: sagepub.com/journals-permissions
DOI: 10.1177/02683555241243161
journals.sagepub.com/home/phl
Perioperative and 1-year outcomes

Paolo Casoni1, Daniele Bissacco2 , Matteo Pizzamiglio1 and Emanuele Nanni1

Abstract
Background: To investigate the use of high intensity focused ultrasound (HIFU) for great saphenous vein (GSV)
incompetence.
Material and methods: Patients with GSV incompetence underwent HIFU. The primary endpoint was the rate of GSV
target segment shrinkage or closure after 1 year.
Results: Out of 188 limbs treated, the GSV treated segment shrinkage/closure rate at 1 week, 3 months, 6 months, and
12 months was 93.3%, 98.2%, 97.6%, and 98.3%, respectively.
Conclusion: These preliminary results suggest that HIFU holds promise for the treatment of GSV incompetence. Further
trials are needed to compare it with other techniques and assess long-term outcomes.

Keywords
High intensity focused ultrasound, chronic venous disease, varicose veins, sclerotherapy

Introduction ultrasound energy absorption, which can be calculated and

The Curie brothers discovered the piezoelectric effect in
1880, which involves certain crystalline materials gener-
ating electricity when subjected to mechanical pressure.1
This discovery led to the development of transducers that
could generate ultrasound (US) waves, with submarine
sonar being one of the earliest applications.2 Today, US is
used in a wide range of devices and processes, including
medical imaging, alarms, vaporizers, plastic welding, and
material cleaning.3
One of the most common medical applications of US is
diagnostic imaging, which has been used for over 40 years
due to its nonionizing nature and real-time imaging capa-
bilities. Despite this, US is also used clinically for thermal
tissue ablation, haemostasis, thrombolysis, and tissue re-
generation, as well as ultrasound-mediated therapeutic
biomolecule and/or drug delivery.4–6
Typically, diagnostic ultrasound is administered at a
power level of 0.1 W/cm⋀2. However, energy doses that
exceed this level are classified into three categories: high
intensity (1,000–10,000 W/cm⋀2), medium intensity, and
low intensity (<3 W/cm⋀2).4
High-intensity focused ultrasound (HIFU) can have both
thermal and mechanical effects on tissues. The thermal
effects involve tissue temperature increasing due to
controlled by changing exposure parameters. In other
words, HIFU uses the thermal effects of ultrasound waves to
treat localized areas, with intensities up to 10,000 W/cm⋀2.7
HIFU has been successfully used to treat various conditions,
including uterine fibroids, prostate cancer, breast cancer,
heart conditions, pancreas, and liver tumours.7,8
In chronic venous disease (CVD), such as varicose veins
and venous insufficiency, potential role and benefits of
HIFU have been known from decades, although the results
have remained preliminary and experimental.9 Only in
recent years have sparse in-vivo data been published10,11 or
remain ongoing12 regarding the use of HIFU for treating
varicosities.
The aim of this article is to investigate short- and mid-
term outcomes in patients who underwent HIFU for vari-
cose veins.
1
Ippocrate Vein Clinic, Parma, Italy
2
Department of Clinical Sciences and Community Health, University of
Milan, Milan, Italy
Corresponding author:
Daniele Bissacco, MD, Department of Clinical Sciences and Community
Health, University of Milan, Via Francesco Sforza 35, Milan 20122, Italy.
Email: daniele.bissacco@unimi.it
2 Phlebology 0(0)
Material and methods
This is a single-centre, observational cohort study regarding
the use of HIFU in treating patients with varicose veins with
or without saphenous trunk incompetence from December
1, 2021, to June 30, 2023. Data were prospectively recorded
and retrospectively analysed. The Strengthening the Re-
porting of Observational Studies in Epidemiology
(STROBE) guidelines and checklist for cohort studies were
used as reporting standard recommendations.13 Approval
for this specific study was waived by local Institutional
Review Board, according to the National Policy in the
matter of the Privacy Act on retrospective analysis of
anonymized data.
Patients
The research included adults ranging from 18 to 89 years
of age who had symptomatic moderate to severe vari-
cosities, as classified by the Clinical, Etiology, Anatomy,
and Pathophysiology (CEAP) system, with a symptom-
atic C2–C6 rating. Symptoms were evaluated and defined
using the SYM-VEIN consensus document.14 Great sa-
phenous vein (GSV), small saphenous vein (SSV), an-
terior accessory saphenous vein (AASV), perforator
veins (PVs), and/or tributaries incompetence were
treated, if necessary, according to colour Duplex ultra-
sound (CDUS) evaluation. In this analysis, only GSV
treatment has been analysed. International guidelines
recommendations15 were used to assess reflux entity,
varicosities pattern, and target vein treatment. In par-
ticular, a reflux time of at least 0.5 s assessed in the
standing position was considered significant. Individuals
were not eligible if they had poor life expectancy
(<1 year) for any comorbidity, were immobilized, had
received prior any treatment for the target vein to be
treated with HIFU, suffered from symptomatic peripheral
arterial disease, had a history of deep venous thrombosis
or pulmonary embolism, or had an aneurysm of the target
GSV larger than 20 mm in diameter.
Once eligibility was confirmed and informed consent
was obtained, participants underwent a baseline assessment,
which included a physical examination with demographic
data collection, completion of CEAP and revised Venous
Clinical Severity Score (rVCSS) assessments,16 and quality
of life (QoL) measurement through the Chronic Venous
Disease quality of life Questionnaire (CIVIQ-20).17 Just
before the treatment, the target vein diameter is measured in
standing and lying position, as well as the skin-vein dis-
tance. HIFU is recommended for treating skin-vein dis-
tances ranging from 8 to 24 mm, with the optimal range
being 10–18 mm.
Sclerotherapy foam technique was used for treating
tributaries, as concomitant or subsequent (<3 months) HIFU
procedure. Sclerotherapy treatment for tributaries followed
international recommendations.18
HIFU device and procedure
All treatments were performed in an outpatient setting with
the Sonovein® HIFU device (Theraclion, Malakoff,
France). This HIFU system is composed of several sub-
systems including a mobile console, a touchscreen user
interface, and a motorized treatment head. The complete
system is shown in Figure 1. The treatment head includes
both a therapy transducer and an ultrasound imaging probe
placed at the centre of the therapy transducer to provide real-
time imaging, targeting, and treatment monitoring. The
imaging probe operates at 7.5 MHz and offers both B-mode
and colour Doppler imaging. The system operates in con-
junction with a single-use disposable kit including a pre-
filled pouch with a degassed fluid, a balloon, and tubes to
connect the balloon to the pouch. The balloon is mounted on
the treatment head and during the treatment, and the fluid
circulates in closed loop from the pouch to the balloon and
back. The temperature of the circulating liquid is contin-
uously cooled at 10°C to remove excess heat from patient’s
skin. When applied to tissue, the focussing of high-power
acoustic beams enables to induce high temperatures locally
(a ‘shot’) at the focus producing a localized tissue ablation
(Figure 2(a) and (b)). Once the saphenous segment to be
treated has been identified, it is compressed by the probe
inducing vein blood emptying and maximizing vein col-
lapse. The ablation starts proximally. Each passage is
performed shooting a 2–3 mm vein segment in 1.5 s. A
cooling period (10–15 s) is necessary between shots. By
doing so, the vein is treated segmentally along its entire
course or selectively in case of haemodynamic conservative
techniques.
Examples of HIFU treatment are detailed below (see
Explanatory examples paragraph).
Postoperative evaluation
Each patient was evaluated after 1 week and then at 1, 3, 6,
and 12 months after HIFU. Postoperative QoL evaluation
was assessed at 1 and 6 months, while postoperative rVCSS
at 1 month. Target vein follow-up status was detected
through colour/Duplex signals during CDUS activating
manoeuvres (e.g. Valsalva and/or squeezing manoeuvres in
standing position, and postural changes to check diastolic
and systolic vein flux as in Paranà manoeuvre). GSV
shrinkage was defined as >50% diameter reduction
throughout all the treated segment of GSV and its closure
when no flow was detected during CDUS with compression
manoeuvre examination.
Postoperative complications were classified in minor
(ecchymosis, transient paraesthesia, indurative pain, and
Casoni et al. 3

Figure 1. The Sonovein® HIFU device (Theraclion, Malakoff, France). With permission. 1. Articulated arm and robotized head. 2.
Visualization and Treatment Unit (VTU). 3. Touchscreen user interface. 4. Coupling and cooling technology.

Figure 2. (a) Operative setting during ablation. (b) Final ultrasound results in a case with significant shrinkage (‘double rail’ sign, black
arrows).
4 Phlebology 0(0)
skin burns) and major (superficial/deep vein thrombosis and
pulmonary embolism).
Primary and secondary endpoints
Primary endpoint was GSV closure or shrinkage rate at
1 year. Secondary outcomes were postoperative compli-
cations rate and GSV shrinkage rate at 1 week, 3 months,
and 6 months.
Statistical analysis
Clinical data were recorded and tabulated in a Microsoft
Excel (Microsoft Corp., Redmond, WA, USA) spreadsheet;
statistical analysis was performed with JMP 16.0 (SAS
Institute Inc., Cary, NC). Missing data were reported during
data extraction and flagged as such ( ). Categorical/
nominal variables were presented using frequencies and
percentages, while continuous variables by mean (µ) ±
standard deviation (SD), or median with interquartile range
(IQR) and ranges, according to data distribution. The
Kaplan–Meier analysis was used to assess shrinkage rate
during the follow-up period.
Results
During the study period, the Sonovein® was used to deliver
high-intensity ultrasound pulses in 250 non-consecutive
patients (Sonovein S for the first 8 months and then So-
novein HD). After learning curve patients’ exclusion, the
analysis was performed in 212 patients (84.8%) and
246 legs (188 [76.4%] GSVs, 13 [5.2%] SSVs, and
45 [18.3%] other veins), as figure out in Figure 3. All GSV
patients primary enrolled were included in this study. CEAP
classes were as follows: C2–C3: 168 patients (88.8%), C4–
C5: 19 patients (10.1%), and C6: two patients (1.1%).
Average age was 59 ± 13 years, with more than two-third
(77.1%) female patients. GSV diameter (measured between
10 and 15 cm from the junction) was 6.6 ± 1.9 mm, up to
15 mm. Most of patients (97.3%) received perivenous
anaesthesia along the treated vein segment with lidocaine
1%, 10 cc, and/or intradermal lidocaine only in more su-
perficial veins. Moreover, one shot ibuprofen 1200 mg was
also administered 30 min before the procedure. The mean
GSV treated segment length was 6.0 ± 2.0 cm.
All patients were discharged at the end of procedure,
with no prophylactic postoperative anticoagulation while an
active venous drug was preferred in all cases, locally, and
Varicotape18 + elastic stockings 24 mmHg for 1 week.
Tributaries foam sclerotherapy was used in treating varicose
veins in 110 patients (59.5%). In particular, patients un-
derwent immediate (51.3%) or postoperative (8.1%)
treatment with low concentration polidocanol foam scle-
rotherapy. Neither deep vein thrombosis nor pulmonary
embolism occurred. Two (1.1%) patients treated with si-
multaneous sclerotherapy experienced superficial vein
thrombosis and 4 (2.2%) transient paraesthesia. CIVIQ-20
improved 3 months after treatment (36.1 ± 11.4 vs 24.3 ±
5.4; p < .01) and at 6 months (22.6 ± 2.6; p = ns), despite this
analysis was provided only in 13 patients. Moreover,
rVCSS improved from 6.4 ± 2.4 to 4.0 ± 1.4 after 1 month
(p < .05).
Figure 4 summarizes follow-up results, highlighting
shrinkage, occlusion, and open vein rates.
Immediate GSV treated segment closure was detected in
42.9% of patients. At 1 week and 3, 6, and 12 months, GSV
treated segment shrinkage/closure rate was 93.2%, 98.1%,
97.5%, and 98.3%, respectively. Complete occlusion was
seen in 74.3% of cases after 12 months. No vein shrinkage
with reflux was seen in 1.7% patients. No residual and/or
recurrent varicose veins were detected after 12 months.
Explanatory examples
To provide a clearer explanation of how HIFU works, we
will present some illustrative examples.
Example 1 (Figure 5(a)). This case involves varicose
veins originating from a GSV perforating vein below or
above the knee. HIFU has been employed to address the
tract between the perforator and varices of the GSV for
obliteration of the saphenous trunk, while simultaneously
converting the perforator into a re-entry perforator.
Example 2 (Figure 5(b)). This scenario represents one of
the most common cases, where there is an incompetent GSV
with a passage above the fascia. In this situation, HIFU is
utilized to treat the saphenous trunk above the collateral
vein, allowing for maximum shrinkage (approximately 5–
6 cm). The collateral vein is also treated to achieve oblit-
eration, akin to the Ablation Sélective des Varices sous
Anesthésie Locale (ASVAL) technique.
Example 3 (Figure 5(c)). This case involves complete
incompetence of the GSV along its entire length. In this
instance, HIFU is employed to create a shrinkage segment
just below the sapheno-femoral junction (approximately 6–
8 cm) and another segment at the mid-thigh level.
It is important to note that varicose vein treatment is
always performed, as mentioned previously.
Discussion
HIFU represents a distinctive solution called echotherapy,
which harnesses the power of therapeutic ultrasound and
ultrasound monitoring. This innovative approach involves
directing a highly focused beam of high-intensity ultra-
sound onto a vein using a magnifying glass. By delivering
thermal energy, the ultrasound’s thermocoagulation prop-
erties affect the vein wall, leading to its shrinkage and
collapse. Through this procedure, a fibrotic seal is created,
Casoni et al. 5

Figure 3. Consort diagram of patients treated with HIFU during the study period (December 2021 to June 2023).

Figure 4. Summary of follow-up findings in 188 patients treated with great saphenous vein HIFU.

leading to the closure of the vessel and significant
shrinkage. Ablation techniques offer the potential not only
to occlude veins but also to restore their normal function and
provide beneficial haemodynamic effects through shrink-
age. This approach takes into consideration insightful
concepts derived from Conservatrice Hémodynamique de
l’Insuffisance Veineuse en Ambulatoire (CHIVA) and
ASVAL.19–21 Indeed, HIFU can be employed in such a
manner, enabling segmental shrinkage or occlusion while
also modifying potential escape points. This approach aims
to minimize the destruction or ablation of veins
simultaneously.
To the best of our knowledge, this study is the first to
provide a comprehensive follow-up of a cohort of over
150 patients who underwent HIFU treatment for GSV in-
competence and varicose veins.
6 Phlebology 0(0)
Figure 5. Explicative examples on the use of HIFU in treating different varicose vein and saphenous trunk patterns (cases are described
in the text).
It is important to underscore several noteworthy aspects
of this potentially revolutionary technique, though some of
them still hold significant importance. HIFU is a non-
invasive, totally out-of-body exothermal technique that
can be used to treat not only the GSV but also others truncal
saphenous trunks, as well as other veins as tributaries and
perforators.10 However, for the purpose of this study, we
focused solely on the GSV as it characterized the most
representative cohort in our experience.
HIFU can be considered as an outpatient procedure,
similar to thermal-tumescent or non-thermal non-tumescent
techniques, but with the advantage of requiring perivenous/
tumescent anaesthesia with a small amount of drug (10 mL
in our cohort). Moreover, in contrast to non-thermal non-
tumescent techniques, HIFU eliminates complications such
as allergic reactions and granulomas. Based on our study,
the only reported complication associated with HIFU is
superficial thrombosis and transient paraesthesia, which is
comparable to the rates observed with other thermal tech-
niques.22 On the contrary, HIFU is not suitable for treating
long vein segments like other endovenous techniques.
However, it is important to note that in this study, HIFU was
employed to restore venous haemodynamic rather than
solely ablating the GSV. The Authors maintain their con-
fidence in the fact that even treating small segments can
effectively eliminate reflux and minimize varicose vein/
saphenous trunk incompetence recurrence rate, according to
CHIVA and ASVAL principles. The choice of which seg-
ment of the GSV to treat depends on the haemodynamic and
anatomical model of the affected limb, as each limb is
unique, driving the treatment thinking that ‘les is more’.
One of the most significant aspects of HIFU is its effect
on the vein wall. The decision to prioritize GSV shrinkage
as the primary outcome is not coincidental. Shrinkage is a
well-known long-term behaviour of the vein wall following
both endovenous thermal (radiofrequency/laser ablation)
and non-thermal (sclerotherapy) techniques, even though it
is not typically considered the main outcome to test the
treatment efficacy, such as ‘vein occlusion’. In our cohort,
HIFU induces a therapeutic shrinkage that effectively
prevents varicose vein recurrence at the 12-month follow-
up. This outcome may be attributed to the unique effect of
HIFU on the vein wall, particularly the endothelium/intima
layer. Some papers on animal models reported shrinkage
Casoni et al.
Figure 6. Colour duplex ultrasound findings after HIFU. (a) Selective exothermal shrinkage (SExTS, black arrows) with the ‘double rails
sign’. (b) Complete exothermal ablation (CExTA, white asterisks). (c) Selective exothermal ablation (SExTA, in the white circle).
after HIFU,23,24 showing thermal denaturation character-
ized by a loss in microfibrillar structure and collagen hy-
alinization, as well as perivascular fat necrosis and limited
muscle necrosis in the superficial perivenous skeletal
muscle 30 days after the procedure.24 Preliminary histo-
logical data from our cohort confirm the exothermal effect
without any observed significant intimal defects just after
the treatment (data currently under analysis and not yet
published). Consequently, shrinkage not only restores a
physiological vein diameter contracting both outermost
tunicae, which is highly beneficial for conservative hae-
modynamic treatments, but it also preserves the integrity of
the vein wall exposed to blood flow, resulting in a ‘real’ vein
restoration (selective exothermal shrinkage, SExTS,
Figure 6(a)). Exothermal effect could also be used to ablate
completely (complete exothermal ablation, CExTA,
Figure 6(b)) or selectively (selective exothermal ablation,
SExTA, Figure 6(c)) the vein, occluding it.
Despite some advantages, HIFU remains burdened by
some limitations. First, the HIFU machine is difficult to
move and moving it can corrupt the calibration. While
HIFU is an ambulatory procedure, it does require a suffi-
cient amount of space to be performed effectively. Second,
immediate results can confound operators, as there is an
immediate vein ablation in less than half of the cases.
Nevertheless, it is important not to be discouraged by this
fact, as wall remodelling takes place gradually. Venous
shrinkage, on its own, primarily results in a GSVof a normal
diameter that is non-refluxing and does not contribute to the
formation of new varicose veins. Therefore, although the
GSV occlusion rate may be lower when compared to other
ablative techniques, the introduction of the novel concept of
therapeutic shrinkage supersedes the traditional definition
of efficacy in invasive venous treatments, resulting in a
primary importance of varicose veins recurrent rate due to
GSV incompetence.25,26
The study has some limitation, primarily due to its
retrospective nature. Furthermore, 1 year of follow-up is
low, despite this is the first report on HIFU outcomes. The
7
low number of SSV prevents a correct and robust analysis
on these patients. Further single-arm controlled studies are
necessary to confirm our data, as proposed by a recent
ongoing trial (NCT04280679),27 and to assess direct and
randomized comparison between HIFU and other ablative
techniques.
Conclusion
HIFU with the Sonovein® device has shown promising
feasibility and efficacy in addressing GSV incompetence,
bringing forth novel perspectives, ideas, and factors to
consider in the realm of varicose vein treatments. In fact, the
HIFU approach has the potential to usher in a transformative
era in vein treatment, including saphenous trunk ablation
and, ultimately, to provide a clearer depiction of the defi-
nition of ‘comprehensive vein restoration’.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with re-
spect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, au-
thorship, and/or publication of this article.
Ethical statement
Ethical approval
The local ethics committee approved this study.
Guarantor
PC.
Contributorship
*Conception and design of the study: PC, DB, MP, and EN.
*Acquisition of data: PC, MP, and EN. *Analysis and interpre-
tation of data: PC, DB, MP, and EN. *Drafting the article: PC and
8 Phlebology 0(0)
DB. *Revising it critically: PC, DB, MP, and EN. *Final approval
of the version to be submitted: PC, DB, MP, and EN.
ORCID iD
Daniele Bissacco  https://orcid.org/0000-0003-0724-0237
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