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An in vitro study to optimise treatment of varicose veins with radiofrequency-induced thermo therapy
George E Badham, Sophie M Strong and Mark S Whiteley
Phlebology published online 12 September 2014
DOI: 10.1177/0268355514552005

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Phlebology OnlineFirst, published on September 12, 2014 as doi:10.1177/0268355514552005

Original Article
Phlebology
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! The Author(s) 2014
An in vitro study to optimise Reprints and permissions:
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treatment of varicose veins with DOI: 10.1177/0268355514552005
phl.sagepub.com
radiofrequency-induced thermo therapy

George E Badham1, Sophie M Strong1 and Mark S Whiteley1,2

Abstract
Objective: To develop a reproducible method of using radiofrequency-induced thermotherapy with adequate thermal
spread to ablate the whole vein wall in a truncal vein but avoiding carbonisation, device sticking and high impedance
‘‘cut outs’’ reducing interruptions during endovenous treatments.
Methods: Porcine liver was treated with radiofrequency-induced thermotherapy under glass to allow measurements,
observation and video recording. Powers of 6–20 W were used at varying pullback speeds to achieve linear endovenous
energy densities of 18–100 J/cm. Thermal spread, carbonisation of treated tissue and high-impedance cut outs were
recorded.
Results: The currently recommended power settings of 18 and 20 W produced sub-optimal results. If pulled back at 3 s/cm
to achieve linear endovenous energy densities around 60 J/cm, tissue carbonisation and high impedance cut outs occurred.
When high powers and fast pullbacks of 1 s/cm were used, no carbonisation or cut outs occurred but thermal ablation of
the liver model was below target due to reduced time for thermal conduction. Low powers (6–12 W) with slow pullbacks
(6–12 s/cm) achieved target thermal ablation with minimal carbonisation and high impedance cut outs.
Conclusions: Using low power (6 W) and a slow discontinuous pullback (6 s every 0.5 cm, in steps), we were able to
achieve our target thermal ablation in the porcine liver model without carbonisation and high impedance cut outs.
This suggests the currently recommended power levels could be reduced, reducing the need to remove the device to
clean the electrodes during treatment while achieving target thermoablation of the treated tissue.

Keywords
Radiofrequency ablation, thermoablation, radiofrequency-induced thermotherapy, varicose veins

truncal veins. The RFiTT catheter uses a bipolar radio-

Introduction
frequency current, having two circumferential
Varicose veins make up a large portion of the work- electrodes at its tip with a small gap between them.
load at every vascular unit. Half of all people over When in contact with the vein wall, alternating current
50 years of age have some signs of venous disease passes between the electrodes at radiofrequency rates.
and half of those people have varicose veins.1 Heat is not generated by the electrodes themselves, it is
The traditional treatment for varicose veins, the generated by the resistance of the surrounding tissue to
high saphenous tie and strip, have been shown to
be associated with several problems including pain,
1
bruising, time off of work, large scars, general anaes- The Whiteley Clinic, Guildford, Surrey, UK
2
thesia and neovascularisation.2 These have led to Faculty of Health and Biomedical Sciences, University of Surrey,
Guildford, Surrey, UK
the development of minimally invasive techniques
This article was presented orally at the 11th International Vascular &
with the aim of permanently destroy incompetent Endovascular Course (IVEC) and the 4th European Congress of the
veins. Catheter-based endovenous thermoablation is International Society for Vascular Surgery (ISVS) in Milan, October
now the recommended first-line treatment for truncal 2010, where it won the third prize.
reflux in the United Kingdom.3
Corresponding author:
Radiofrequency-induced thermotherapy (RFiTT) MS Whiteley, The Whiteley Clinic, Stirling House, Stirling Road,
(Olympus Europa, Hamburg) is a catheter-based Guildford, Surrey, GU2 7RF.
thermo-ablative endovenous treatment for refluxing Email: mark@thewhiteleyclinic.co.uk

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2 Phlebology 0(0)

the passage of the alternating current. The impedance operators get poor results and need to be excluded
of the tissue, not the temperature, is constantly from a study.9 However, a recent publication has
measured by the RFiTT device, which feeds this infor- shown that using high powers and fast pullbacks,
mation back to the operator via an audible pitch-based multiple passes might be needed for optimal results
signal. There is no independent referenced data at this and has identified removing the catheter for cleaning
time regarding in vivo temperatures reached in RFiTT as a problem.11
treatment. The aim of this study was to develop a reproducible
The impedance is measured between the electrodes method of using RFiTT in an in vitro model that can
and hence changes in the impedance reflect changes in achieve an LEED of >60 J/cm but without causing
the intima. During treatment, the intima starts to the catheter to stick to the tissue being treated, carbon-
desiccate due to the heat and the impedance increases. isation or high impedance cut outs, all of which are
The RFiTT monitor constantly measures this imped- associated with the currently recommended high
ance and provides feedback to the operator via an power settings of 18–25 W.
audible tone. As the tissue desiccates further, the
impedance increases and the tone increases in pitch
until it reaches a level where the generator automatic-
Methods
ally cuts out as a safety measure. A ProCurve 1200-S15 (Olympus, Hamburg) applicator
Unfortunately, the measured impedance is not the was used with the CelonLab Precision RFiTT power
impedance of the whole vein wall but the impedance generator (Olympus, Hamburg). Porcine liver was
of the innermost layers of the vein wall – intima and treated with RFiTT under glass. This enabled the obser-
perhaps the innermost part of the media. In addition, vation and high-resolution photographic documenta-
the quicker the energy is applied to the vein (i.e. the tion of the effect of different withdrawal speeds and
higher the power), the quicker the intima desiccates, power settings.
the quicker the impedance rises and the less chance The method of treatment was as follows. Fresh
there is for the heat to penetrate the vein wall to Porcine liver was placed on a laboratory surface.
ablate the whole of the media layer. As such, high The liver was covered liberally with normal saline.
impedance cut outs before an adequate linear A ruler marked in centimetres with millimetre
endovenous energy density (LEED) has been reached divisions was placed on the liver surface. Close by,
represents an inadequate treatment of the vein wall and parallel to this ruler, the RFiTT catheter was
and if these cut outs keep happening during a treat- placed on the liver surface. More normal saline was
ment, they become very irritating for the operating spread over the area and a sheet of glass placed on top
doctor. of the liver, ruler and RFiTT catheter. The weight of
Previous thermoablation studies have shown good the glass flattened the liver surface and pushed the
levels of closure of great saphenous veins (GSV) with a RFiTT catheter into the liver tissue, ensuring the cath-
LEED > 60 J/cm both in RFiTT4 and endovenous laser eter was surrounded by liver on three sides – only the
therapy.5 However, current literature on RFiTT favours side adjacent to the glass was free of contact with liver
high power levels between 18 and 25 W both in ex vivo tissue. Thus thermal spread from the edge of the
experiments6 and in clinical trials,7–9 with withdrawal RFiTT catheter could be observed spreading above
rates of approximately 1.0 s/cm giving an LEED of and below the catheter, giving a view as if in
only 20 J/cm. There seems to be no clear justification cross-section of tissue being treated.
for this recommendation in veins other than experience The camera mounted above the glass recorded
with previous generations of this technology used in these thermal spreads as the RFiTT catheter was
other areas such as tumour ablation10 and the ex vivo set to different powers and different pullback speeds
work looking for circumferential necrosis seen on were used.
histology.6 Regardless of power or pullback, each treatment
Despite published clinical studies reporting closure length was 5 cm. All catheter pullbacks were smooth
rates 88.9–98.9%, one study concluded that RFiTT and continuous with the exception of the final ‘‘discon-
needed ‘‘improvement in treatment parameters’’8 and tinuous’’ method we developed in order to make the
two of the studies showed that slowing down the technique easier to perform and for others to
pullback resulted in higher rates of occlusion,7,9 and reproduce.
the best results reported achieving the high levels of The settings tested are in Table 1. The one discontinu-
occlusion only when the results from ‘‘inexperienced’’ ous pullback technique used a power of 6 W and started
operators (<20 cases) were excluded.9 Very little data with a 6 s treatment with the catheter stationary.
has been published as to why the current treatment The device was then withdrawn 0.5 cm and then
parameters are sub-optimal8 or why ‘‘inexperienced’’ another 6 s of treatment was performed. This was

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Badham et al. 3

Table 1. Settings used in this study classified by increasing

LEED.

LEED (J/cm) Power (W) Pullback (s/cm)

18 18 1
20 20 1
60 20 3
Figure 1. Porcine liver treated with RFiTT at 20 W with
72 18 4
pullback of 5 s/cm (LEED ¼ 100 J/cm). Continuous high
72 12 6 impedance cut outs made it impossible for the operator to
72 6 12 use these settings. Tissue carbonisation is clearly seen in the
72 6 6 s/0.5 cm* treatment tract.
100 20 5
LEED: linear endovenous energy density.
*All pullbacks are continuous except that indicated with asterisk, which
was discontinuous (6 s treatment, then pullback 0.5 cm, then repeat).

repeated every 0.5 cm. Very quickly, the operator found

it easy to pullback in 0.5 cm steps without stopping the
generator, speeding up the treatment while keeping the
same stepwise treatment. Figure 2. Treatment settings of 18 W with a pullback of 4 s/cm
(LEED ¼ 72 J/cm). These settings produced high impedance cut
All withdrawals were carried out by a surgeon experi-
outs and a low thermal spread in the tissue. Some tissue
enced with endovenous techniques. Carbonisation,
carbonisation is seen in the treatment tract.
characterised by black carbon being visible in the treated LEED: linear endovenous energy density.
tissue, sticking of the electrodes to the burnt tissue and
high impedance generator cut outs were noted.
Carbonisation was deemed as ‘‘unacceptable’’ when The measurements of thermal spread between the
the carbon had accumulated sufficiently to cause a different settings were plotted on a graph with error
high impedance cut out and the catheter had to be bars 2 SD from the norm for ease of seeing statistical
removed and cleaned before treatment could be contin- differences between the groups at the 95% confidence
ued. High-resolution photographs were taken of each interval and results were also analysed for statistical
treatment with a Dermascope camera. This allowed significance using the Student’s t-test for parametric
the thermal spread to be measured by using pixel to continuous data.
millimetre conversion. Thermal spread was measured
at seven sites on each treatment tract, measurements
being made 0.5 cm apart. The first and last centimetres Results
of treatment were excluded to reduce error. The stand- Carbonisation of tissue, catheter sticking and high
ard error of each data set was used to compare the
data and judge the possible statistical significance.
impedance cut outs
Four different pullbacks were used for each power and A power level of 20 W with a pullback speed of 5 s/cm
pullback setting giving 20 measurements in total for each (LEED ¼ 100 J/cm) produced an unacceptable level of
setting. carbonisation, constant sticking of the electrodes to
The thickness of the saphenous vein wall has been the treated tissue and almost continuous high imped-
found to be highly variable but has been documented as ance cut outs (Figure 1). Therefore this setting was not
being between 0.18 and 0.65 mm.12 Knowing the simi- repeated. Other high impedance related cut outs were
larity of the thermal spread in our model compared observed five times in the 18 W at 4 s/cm
with GSV (see above), and knowing that we wanted (LEED ¼ 72 J/cm) (Figure 2) and once in the 20 W
to achieve transmural ablation of the vein wall in at 3 s/cm (LEED ¼ 60 J/cm) (Figure 3). At these two
every patient to be happy we had optimal treatment settings, we also observed some carbonisation of the
of the vein,13 we set the target for ‘‘adequate treatment’’ tissue with occasional sticking of this tissue to the
for this study to achieve visible thermoablation of the electrodes.
porcine liver to spread at least 0.65 mm laterally None of the other settings tested caused carbonisa-
from the edge of the treatment electrodes on the tion of the tissues, catheter sticking nor had any high
RFiTT device. impedance cut outs.

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Thus of the settings tested (see Table 1), the three

Thermal spread
settings with the recommended powers for RFiTT The thermal spread results are shown graphically with
treatment (18 or 20 W) with pullbacks designed to error bars 2 SD from the norm (Figure 4). At LEEDs
make sure the LEED is > 60 J/cm, all showed problems of 18 J/cm (Figure 5) and 20 J/cm (Figure 6), there was
of tissue carbonisation, catheter sticking to tissue and
high impedance cut outs. The only two settings at these
power levels that did not cause these problems of over
burning the test tissue were those that had such quick
pullbacks, that the LEED dropped to 18 and 20 J/cm,
both levels significantly below the LEED needed for
confident closure of the GSV.
In contrast, all of the settings using lower powers
and slower pullbacks managed to achieve LEEDs
of 72 J/cm without any carbonisation of test tissue, Figure 5. Treatment settings of 18 W with a pullback of 1 s/cm
catheter sticking or high impedance cut outs. (LEED ¼ 18 J/cm). This setting shows inadequate thermal spread
in the tissue to reach our target of 0.65 mm (see text).
LEED: linear endovenous energy density.

Figure 3. Treatment settings of 20 W with a pullback of 3 s/cm

(LEED ¼ 60 J/cm). These settings showed that the target thermal Figure 6. Treatment settings of 20 W with a pullback of 1 s/cm
spread had been achieved but some high impedance cut outs were (LEED ¼ 20 J/cm). This setting shows inadequate thermal spread
experienced with some tissue carbonisation and device sticking. to reach our target of 0.65 mm (see text).
LEED: linear endovenous energy density. LEED: linear endovenous energy density.

Figure 4. A graph to show the mean thermal spread at each tested setting. Error bars  2 SD from the norm. Only LEEDs >60 J/cm
showed thermal spread in the tissues that reached our target of 0.65 mm (see text).
LEED: linear endovenous energy density.

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Badham et al.
<0.5 mm of thermal spread laterally from the edge of
the RFiTT device. Using our cut off of 0.65 mm as
above, these two settings failed to achieve our target
thermal spread from the device.
All LEEDs >60 J/cm showed thermal spread
>1.0 mm laterally from the edge of the RFiTT device.
As can be seen graphically in Figure 4, the techniques
using slower pullback speeds had larger thermal effect
radii, even though they used lower powers. This shows
that slower rates of application of thermal energy allow
further thermal spread in the tissue surrounding the
device. However, the difference between the 20 W at
3 s/cm (LEED ¼ 60 J/cm) (Figure 3) and the 18 W at
4 s/cm (LEED ¼ 72 J/cm) (Figure 2) methods was not
significant (p > 0.05).
The 12 W at 6 s/cm (LEED ¼ 72 J/cm) (Figure 7) and
6 W at 12 s/cm (LEED ¼ 72 J/cm) (Figure 8) settings did
not show any significant difference of thermal spread.
However, both were more effective than the 18 W at
4 s/cm (LEED ¼ 72 J/cm) method (Figure 2) (p < 0.05).
The discontinuous method of pullback (6 s at 6 W,
then pullback 0.5 mm and repeat for the length of vein
to be treated) giving an LEED of 72 J/cm) (Figure 9)
produced a mean thermal spread of 1.66 mm, which
was significantly higher than any other setting tested
(p < 0.05 against all other settings).
Figure 7. Treatment settings of 12 W with a pullback of 6 s/cm
(LEED ¼ 72 J/cm). This setting shows thermal spread greater than
the target of 0.65 mm and showed no carbonisation, device
sticking or high impedance cut outs.
LEED: linear endovenous energy density.
Figure 8. Treatment settings of 6 W with a pullback of 12 s/cm
(LEED ¼ 72 J/cm). This setting shows thermal spread greater than
the target of 0.65 mm and showed no carbonisation, device
sticking or high impedance cut outs.
LEED: linear endovenous energy density.
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5
Discussion
Any in vitro model will have differences from the
in vivo situation. Without doubt, the fact that the cath-
eter is pressed against the glass shows that it is not
surrounded by biological tissue as it would be when
in the vein during an actual treatment. However, this
model enables thermal spread to be easily observed and
measured and so, as this model appears to predict the
effects seen in the ex vivo GSV (see below), it would
appear to be adequate to derive the conclusions reached
in this article.
In vivo, the truncal vein being treated is surrounded
by tumescence. This separates the vein from the sur-
rounding sub-cutaneous fat and when combined with
a ‘‘head-down’’ position, causes the vein to contracted
around the catheter, virtually exsanguinating the
vein and leaving no significant blood within the
lumen. The vein wall itself is not infiltrated with tumes-
cence. Hence the normal saline spread liberally over
this model will mimic the presence of tumescence
around the catheter.
Porcine liver was chosen for our in vitro study
for four reasons. First, there is a precedent for using
porcine liver to investigate the thermal effects of radio-
frequency on biological tissue.14 Second, the cells dens-
ity in porcine liver is similar to that in GSV. Third,
porcine liver is a dark colour and when treated with
thermoablation, the ablated tissue turns a light
colour. The tissue turning lighter is due to the thermal
changes in the tissue itself, representing a denaturation
of the protein in the cells, which would correspond to
cellular damage and probable death in living tissue.
This contrast of colour makes measurements easy.
Finally, we have performed a correlation study showing
that there is a close correlation between results found
using the assumptions made in about thermal spread
measured in this model and that found by the same
treatment in explanted GSVs. That article is also
Figure 9. Treatment settings of 6 W with a discontinuous
pullback of 12 s/cm performed as 6 s stationary, withdraw 0.5 cm
then repeated (LEED ¼ 72 J/cm). This discontinuous pullback
showed the highest mean thermal spread and was easiest for the
operator to perform reliably and repeatedly.
LEED: linear endovenous energy density.
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6 Phlebology 0(0)

being submitted for peer review for consideration of To maintain the high LEED of >60 J/cm but to
publication.13 overcome the carbonisation and sticking to the tissue,
Doctors using RFiTT and the recommended treat- we have shown that by reducing the power first to 12 W
ment levels of 18–25 W often report at conferences and then further to 6 W, we can achieve our target
that treatments are interrupted by high impedance thermal spread with no tissue carbonisation or device
cut outs and the need to remove the device to clean sticking at all. Indeed, the lowest power (6 W) with the
carbonised tissue from the electrodes (often called slowest pullback (12 s/cm) produced the best thermal
‘‘coagulum’’). spread of all settings tested and no tissue carbonisation
We have shown that the original recommendation or device sticking at all and hence no high impedance
and previously prescribed techniques of 20 or 18 W at cut outs during the treatments.
1 s/cm (LEED ¼ 18 or 20 J/cm, respectively) give very However, although it is necessary to slow the
poor thermal spread, which would not cause trans- pullback speed with the lower powers to maintain
mural death in all GSVs. Therefore, we would expect the LEED, this slow device withdrawal is not without
a proportion of veins treated with this technique to its problems. The slow, continuous 12 s/cm pullback
show reopening of the treated veins in time. necessary to achieve LEEDs of 72 J/cm without carbon-
These views are supported in the written literature isation is difficult for the operator to perform accur-
with studies reporting the outcomes from using these ately and repeatedly. It became clear to us that when
settings showing some failures, with improved results pulling back at 12 s/cm, a small deviation in pullback
being found if the pullback is slowed from 1.0 to over rate could cause a large disparity in the results, decreas-
1.4 s/cm.7,9 However, high levels of successful ablation ing the potential effectiveness of the procedure. Hence
are reported only when the poor results from ‘‘inexperi- we developed a staged discontinuous pullback of 0.5 cm
enced’’ doctors (fewer than 20 cases) were excluded.9 every 6 s, which we found allowed the operator
Presentations at conferences by ‘‘experienced doc- to achieve far more reproducible results in terms
tors’’ about the technique of performing RFiTT often of LEED.
include recommendations to treat with multiple passes The reason that 0.5 cm was selected as a pullback
to ensure closure and to reduce the chance of high length rather than 1.0 cm, which would have been
impedance cut outs and the need to remove the device easier, was because of the pattern of heat effect gener-
for cleaning, and a recent publication has echoed this ated by the treatment tip of the RFiTT device. When
advice.11 observing the use of the device in the porcine liver
The carbonisation of the tissue as described in this model under glass, it was clear that the heat was
in vitro model probably corresponds to two clinical generated in the tissue between the two electrodes,
problems. The first is the sticking of the catheter and not directly at the tip or on the electrodes themselves.
the formation of coagulum that needs to be removed10 Simple observation of the shape of the thermal spread
and the second is that for successful thermoablation, within the tissue showed us that when using 0.5 cm
the vein wall only needs to be heated until the majority treatment lengths, the areas of thermally treated tissue
of the cells in the walls are coagulated and dead.15 overlapped each other. When using 1.0 cm treatment
Carbonisation either means excessive energy has been lengths, the overlap between the treatment areas was
used, or more likely that there has been inadequate insufficient, leading to areas between the treatment
thermal spread in the wall with excessive heat damage points where the thermal spread did not meet the min-
causing carbonisation of the innermost layers and leav- imum target thermal spread of 0.65 mm. We felt that
ing the outer layers of the wall alive, leaving the risk of this could represent a potential clinical failure of treat-
subsequent recannalisation.16 ment and so was rejected in favour of the 0.5 cm treat-
We have shown that the higher power levels of ment lengths that did not leave any areas under the
18 and 20 W tend to burn the tissue in contact with target thermal spread.
the device, causing carbonisation and sticking of the For this study we have used an in vitro model rather
device, necessitating a fast pullback that reduces ther- than an in vivo model. Therefore, findings, although
mal spread in the tissues. The 1 s/cm pullback at these clear in the porcine liver model, will need to be con-
powers resulted in low LEEDs and poor thermal spread firmed in human GSV and also in clinical practice.
in the tissue, falling far short of our target 0.65 mm in These studies have been now been performed and
this model. When we tried to increase the LEED have been submitted for consideration for publication
towards 60 J/cm while using the higher power level of In conclusion, using an in vitro porcine liver model,
18 or 20 W by utilizing a slower pullback, we found we have shown that when using RFiTT, a low
carbonisation of the tissue and sticking of the device, power setting of 6 W combined with a slow pullback
although thermal spread within the tissue did increase of 12 s/cm produces a larger thermal spread than a high
and pass our 0.65 mm target. power setting and rapid pullback. We have confirmed

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Badham et al. 7

that an LEED of >60 J/cm is needed to achieve a ther- 6. Reich-Schupke S1, Mumme A and Stücker M.
mal spread >0.65 mm, which we chose as our target to Histopathological findings in varicose veins following
represent transmural thermal death in the GSVs with bipolar radiofrequency-induced thermotherapy–results
the thickest walls. We have also found that slow pull- of an ex vivo experiment. Phlebology 2011; 26: 69–74.
7. Camci M, Harnoss B and Akkersdijk G. Effectiveness
back necessary to achieve LEEDs of 72 J/cm is difficult
and tolerability of bipolar radiofrequency-induced ther-
for the operator to perform consistently. We have motherapy for the treatment of incompetent saphenous
suggested a discontinuous pullback technique of 6 s veins. Phlebologie 2009; 38: 5–11.
treatment at 6 W with the device stationary, followed 8. Tesmann JP, Thierbach H, Dietrich A, et al.
by a 0.5 cm withdrawal and then a repeat of this cycle Radiofrequency induced thermotherapy (RFITT) of vari-
until the whole target length of tissue had been treated, cose veins compared to endovenous laser treatment
which we showed to be easy to perform and reproduce. (EVLT): a non-randomized prospective study concentrat-
ing on occlusion rates, side-effects and clinical outcome.
Acknowledgements Eur J Dermatol 2011; 21: 945–951.
9. Braithwaite B, Hnatek L, Zierau U, et al.
The authors would like to thank Simon Ford of Olympus,
Radiofrequency-induced thermal therapy: results of a
who started experimenting with different power levels in an
European multicentre study of resistive ablation of
in vitro model and shared his early results with us. It was
incompetent truncal varicose veins. Phlebology 2013; 28:
Simon Ford’s work that gave us the clue to developing our
38–46.
method of obtaining an LEED of 72 J/cm for optimal treat-
10. Häcker A, Vallo S, Weiss C, et al. Technical character-
ment of the veins. We would also like to thank Mr Barrie
ization of a new bipolar and multipolar radiofrequency
Price of The Whiteley Clinic for his suggestion of using the
device for minimally invasive treatment of renal tumors.
pixel to mm conversion to measure the thermal spread.
BJU Int 2006; 97: 822–828.
11. Newman JE, Meecham L, Walker RJ, et al. Optimising
Conflict of interest treatment parameters for radiofrequency induced thermal
The authors declare there is no conflict of interest therapy (RFiTT): a comparison of the manufacturer’s
treatment guidance with a locally developed treatment
Funding protocol. Eur J Vasc Endovasc Surg 2014; 47: 664–669.
Whiteley Clinic Research Grant. 12. Canham PB, Finlay HM and Toughener DR.
Contrasting structure of the saphenous vein and internal
mammary artery used as coronary bypass vessels.
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