Key words varicose - laser ablation - EVLA - recurrence - duplex ultrasound
Schlüsselwörter Varizen - Laserablation - EVLA - Rezidiv - Duplexsonografie
Introduction
Endovenous thermal ablation of insufficient vein segments in case of truncal venous
insufficiency has become a standard procedure in the past 15 years. The wide adoption
of this procedure, particularly compared with classical crossectomy and stripping,
can be attributed to its generally low surgical burden with minimal invasiveness and
potentially lower risk of post-operative haematomas and pain. Furthermore, owing to
their effectiveness, laser and radiofrequency ablations have been incorporated in
the guidelines of professional societies for primary varicose veins. For example,
in the NICE guidelines from the UK and guidelines of the Society for Vascular Surgery
and American Venous Forum in the US, endovenous thermal ablation was preferred to
classical surgical procedures [1 ]
[2 ]. Moreover, in the current guideline of the European Society for Vascular Surgery
(ESVS) published in 2015, radiofrequency and laser ablations of the great saphenous
vein (GSV) are a 1A recommendation to crossectomy in combination with stripping’ [3 ].
In Germany, the procedure is considered equivalent to surgery in the recent guideline
issued by the German Society of Phlebology [4 ]. However, the use of endovenous thermal ablation in the treatment of recurrent varicose
veins is less established. Recurrences occur after all types of varicose vein treatment.
A recurrence rate of up to 65 % after 11 years has been reported in the literature
[3 ]. After varicose vein surgery or endovenous ablation for insufficiency of the GSV
or small saphenous vein (SSV), the recurrence of inguinal or popliteal varicose veins
is common and requires careful management. From a surgical perspective, elimination
of recurrence at the proximal insufficiency point, analogous to classical surgical
procedures or endovenous intervention, is the most consistent type of treatment. However,
because of subsequent treatment, the open surgical treatment of such a condition is
technically challenging and is associated with a high risk of complications [5 ]
[6 ].
The ESVS guideline recommends considering endovenous ablation of the recurrent varicosis
if it appears to be suitable [3 ]. However, the boundaries at which this method appears suitable are dynamic . Conversely,
considering progress in the development of catheter systems, such as radially emitting
laser fibres with wavelengths of 1470 nm and 1940 nm, and with increasing experience
of the clinicians, this study aimed to examine the current state of endovenous thermal
ablation for recurrent varicose veins in the available literature and from the perspective
of a regular user.
Morphology of recurrences
Morphology of recurrences
In this section, we present the morphological characteristics of recurrence based
on our clinical experience. Presenting an analysis similar to existing or newer classifications
for recurrences after surgical or endovenous pre-treatment would be too complex in
this study; reference is made to specific literatures for this purpose [7 ]
[8 ]
[9 ]. The aetiology of recurrences, i.e. whether a stump or neovascularisation predominates,
cannot always be clearly assigned sonographically [10 ].
On the one hand, distal recurrence findings are regularly found where there is no
detectable connection to the former juction of the pre-treated vein area. In most
cases, such recurrences can be treated well with endovenous therapy, especially if
they include larger perforating veins or refluxive parts of residual truncal veins
or large side branches.
In varicose vein recurrences originating from the former saphanofemoral or saphenopopliteal
junction, the proximal insufficiency point is the (former) transition of the treated
vein with the deep vein. Cases may show a defined stump or varicose bundles/tangles
without a defined stump. In either case, thermal ablation is sometimes challenging.
Periodically, this varicose vein new reflux is part of a more extensive recurrence
network involving dependent, relatively straight reflux truncal vein segments, in
which the latter is often easier to occlude thermally than the supplying proximal
insufficiency point.
The endovenous treatment of varicose vein recurrences can also be relatively easy
to perform, particularly if a persistent varicose vein stump is directly connected
with a similarly persistent, straight truncal vein residue or large side branch, such
as the anterior accessory saphenous vein (AASV). This pattern recurs after endovenous
thermal ablation of the GSV when the AASV, which also opens in the varicose vein area,
is not thermally sealed. An improvement may result from the flush occlusion of the
GSV, in which inflowing side branches in the varicose vein area may be sealed more
effectively, or through prophylactic ablation of the AASV [11 ]
[12 ]
[13 ].
In a special consecutive case series, the proportion of recurrent varicose veins originating
from the safenofemoral junction, which may be designated as technically ‘difficult,’
since there were stumps or neovascularizations, was 63 %. In contrast, 37 % are attributable
to a somewhat ‘easier’ group with a persistent, refluxing truncal vein [14 ].
Endovenous thermal ablation of recurrent varicose veins: Literature review
Endovenous thermal ablation of recurrent varicose veins: Literature review
Initially, a Pubmed search was performed with the following search terms: recurrence , recurrent , recurring , relapse , varicose , varicosis , varices , laser and radiofrequency . Additionally, current relevant guidelines of the DGP, ESVS and AFV were analysed.
In total, only eight relevant papers were identified ([Table 1 ]). However, we cannot preclude that there are more unrecorded study data on this
topic. The main findings from the literature review are briefly summarised in the
following chapter.
Table 1
Literature review on endovenous ablation for recurrence.
(first) author, year
method
study type
n
therapy success
follow-up
Hinchliffe, 2006 [15 ]
radiofrequency
randomised double-blind study
16 (RFA)
16 (OP)
16/16
16/16
only post-operative mortality was evaluated. RFA had a significantly better pain score
and fewer haematomas.
Nwaejike, 2010 [19 ]
laser (bare fibre)
consecutive case series
77
100 %
median follow-up duration, 18 months (range, 1–38)
van Groenendael, 2009 [16 ]
laser (bare fibre)
prospective cohort study
67 (ELLA)
149 (OP)
81 % (ELLA)
71 % (OP)
GSV recurrences, 6-month follow-up
van Groenendael, 2010 [17 ]
laser (bare fibre)
prospective cohort study
26 (ELLA)
16 (OP)
26/26 EVLA)
15/16 (OP)
SSV recurrences, initial technical success
Theivacumar, 2011 [18 ]
laser (bare fibre)
prospective matched-pair study
104 (recurrence)
102/104
3 months
Turtulici, 2017 [20 ]
radiofrequency
case series
37
24/29
12 months
Cavallini, 2018 [21 ]
radial laser
consecutive case series
9
8/9
median follow-up duration, 8 months
Müller, 2020 [14 ]
radial laser
consecutive case series
35
34/35
only initial success was evaluated.
Current status of the literature on thermal ablation for recurrent varicose veins
with a truncal vein segment
Current status of the literature on thermal ablation for recurrent varicose veins
with a truncal vein segment
A considerably detailed randomised, blinded study by Hinchliffe et al. analysed patients
with recurrent varicose vein findings on both sides who were treated with radiofrequency
in one limb and cross-revision and stripping in the other limb [15 ]. The patients were ‘blinded’ and did not know postoperatively which procedure had
been performed on which side because the bandages were similar. Likewise, personnel
who photographically documented haematomas were ‘blinded’ because the evaluation was
performed after a few days of taking the photographs. As a result, the radiofrequency
procedure was considered more favourable than surgery in terms of pain and haematoma
development.
Two other studies on surgery, one on recurrent varicose veins in the GSV flow area
[16 ] and the other on recurrent varicose veins of the SSV [17 ], had a prospective comparative study design and showed slightly better therapeutic
success for endovenous treatment using bare fibre. Another prospective matched-pair
analysis compared cases with endovenous laser ablation for recurrence with a contrast
intervention with primary GSV or SSV insufficiency [18 ]. The longest follow-up duration published to date after laser ablation of a recurrence,
based on a consecutive case series of 77 treatments, was reported by Nwaejike et al.
[19 ]. During a median follow-up period of 18 months, a closure rate of 100 % was achieved.
Data on endovenous treatment of recurrences are mainly based on limited findings with
persistent straight vein segments suitable for puncture and thermal ablation using
bare fibre or radiofrequency catheters. In contrast, ablation of short varicose vein
stumps or neovascularisation is not performed. From the abovementioned studies, a
recommendation can be derived from the ESVS guideline that, correspondingly, endovenous
thermal treatment for a suitable truncal vein should be considered [3 ].
Review of the literature on thermal ablation of varicose vein stumps
Review of the literature on thermal ablation of varicose vein stumps
There is limited published data on endovenous thermal ablation of recurrence findings
with short varicose vein stumps or those that correspond more to the phenotype of
neovascularisation. In 2017, Turtulici et al. published a case series on radiofrequency
ablation of recurrence findings with a rigid probe that was inserted not via a feeding
vein but directly transcutaneously into the vein bundle to be sealed [20 ]. However, the device used was a probe applied in the thermal ablation of round foci
in parenchymatous organs, such as liver tumours, and should not be combined with typical
endovenous radiofrequency catheters such as Closurefast. During the follow-up period
of 12 months, 24 of the 29 treated patients showed successful closures in the thermally
treated area.
An Italian working group reported successful ablation of a complex recurrent varicose
vein using a radial laser with a consecutive case series. The group used a wavelength
of 1470 nm in the Elves Radial slim catheter. Varicose vein stumps were punctured
with a peripheral vein catheter (16 G). Therefore, the tip of the plastic cannula
was positioned close to the deep vein or advanced into it [21 ]. The use of several cannulas for the treatment of more extensive recurrences has
also been described. In all (n = 9) treated cases of recurrence, additional varicosectomies
were performed, and in 7 cases, sclerotherapies were conducted. During follow-up (average
follow-up period, 8 months), successful treatment was noted in eight of nine cases.
In our published consecutive case series, the initial technical success of 35 treatments
of varicose vein recurrence in the GSV flow area was analysed [14 ]. In 34 cases (97.1 %), successful early ablation was documented. Our study also
made a distinction analogously to the ‘simple’ and ‘difficult’ types of varicose vein
recurrence, in which effective endovenous treatment was evaluated as practicable in
both situations.
Conclusion from the literature review
Conclusion from the literature review
Two points can be derived as significant conclusions of the literature review: First,
available data on the treatment of recurrent varicose veins, which are the basis of
the ESVS guideline, describe only a subgroup, namely, that with straight vein segments
to be treated with bare fibre or a radiofrequency catheter [3 ]. Second, no reliable statements can be made on the effectiveness of endovenous thermal
ablation of problematic recurrent varicose veins, such as short varicose vein stumps
or neovascularisation, based on Pubmed literature.
Techniques of endovenous treatment for varicose vein recurrence
Techniques of endovenous treatment for varicose vein recurrence
Essentially, the technique performed at our institution corresponds to the procedure
described by Cavallini et al. [21 ]. We used the latest-generation laser devices, such as the 1470-nm Elves Radial (Biolitec
AG, Vienna) or 1940-nm Simla 6 (Ims GmbH, Tutzing). Because they deliver radial energy,
modern lasers allow controlled sealing of the vein wall in projection to the sonographically
trackable catheter tip.
In cases where the transition between a varicose vein stump and the deep vein has
a wide lumen (> 1 cm) and is sonographically well recognisable, the 1470-nm Elves
Radial 2ring is preferentially used via the access created according to the Seldinger
technique because of its high thermal effectiveness. First, the stump is punctured
using a hypodermic needle and secured into the deep vein, utilizing a guidewire with
feed. Then, a 6-Fr vein lock is advanced, followed by the catheter, into the deep
vein. After pulling the lock, the catheter is withdrawn under ultrasound guidance
until its tip reaches the transition between the stump and deep vein ([Fig. 1 ]). Subsequently, the tumescent solution is inserted, and care must be taken to ensure
that this does not significantly change the position of the catheter tip. If this
occurs, it needs to be corrected, which may be time-consuming after tumescent infusion
due to poor ultrasound conditions.
Fig. 1 Case studies on endovenous ablation for inguinal a–c and popliteal d–f varicose vein recurrence. Pre-operative ultrasound findings in inguinal varicose
vein recurrence in a transverse section. b Intra-operative ultrasound documentation for positioning the laser fibre tip (arrow)
at the site of transition from the deep vein to the GSV stump. c Post-operative colour duplex findings after 10 days with a thermally deactivated
varicose vein stump. d Pre-operative colour duplex findings of popliteal recurrence with a short stump and
directly attached to the vein bundle. e Intra-operative ultrasound documentation when the introduction tools, according to
the Seldinger technique, are advanced into the popliteal vein before the radial laser
is positioned precisely at the transition between the stump and deep vein by withdrawal.
f Post-interventional colour duplex findings with thermally deactivated recurrence
after 2 months. VF, common femoral vein; VP, popliteal vein.
The abovementioned steps, which may be challenging and require a specific routine
in the endovenous technique, are facilitated by the use of general anaesthesia and,
simultaneously, the use of little or no tumescence.
Occasionally, the transition from the recurrent varicose vein to the deep vein cannot
be identifiable; thus, based on the Seldinger technique, access is not possible. One
option is using thinner Elves Radial 2ring Slim-Fraser fibre (Biolitec) or analogously
the Ims400-Fraser (Ims GmbH). They can be inserted through 16-G venous cannulas, whereby
the latter is extremely easy to place with their tip in the position where laser ablation
is to be initiated. Even if the area of effective transition into the deep vein is
not permanently sealed, successful ablation is achieved in most cases. In case of
more complex recurrences of varicose veins, this technique can be used to puncture
several vein segments through the cannula prior to the procedure and, thus, secure
them for further thermal treatment before the inserted tumescence prevents further
punctures ([Fig. 2 ]).
Fig. 2 . Example of a case of endovenous ablation with complex popliteal recurrence. a Pre-operative colour duplex with representation of extensive recurrence both below
and above the popliteal fascia. b Pre-operative finding in the B-scan. c To ablate this extensive finding, multiple vein routes had to be thermally deactivated.
For preparation, they were initially punctured using three 16-G venous cannulas, employing
the 1470-nm Elves Radial 2ring slim catheter, and then threaded before the infusion
of tumescence and ablation. d Post-operative colour duplex findings after 2 months with a thermally deactivated
recurrence finding.
Another technique is the threading of longer, curved vein sections onto the puncture
cannula. Within limits, we also accept it here if the venous cannula runs in a short-stretch
paravascular manner. For this purpose, the position of the transducer may vary to
optimally follow the course of the vein. From our perspective, it is always advantageous
to eliminate the varicose reservoir as effectively as possible. Thus, simultaneous
with the treatment of a varicose vein recurrence, more distally located reflux vein
sections should be treated using laser therapy or foam sclerotherapy or excision for
tortuos varicose veins. Another helpful technique is the retrograde puncture of the
superficial epigastric vein or superficial circumflex iliac vein if varicose drainage
occurs from these veins.
Pitfalls and possible limitations of endovenous recurrence treatment
Pitfalls and possible limitations of endovenous recurrence treatment
In a large number of cases, recurrent varicose veins can be safely treated by endovenous
thermal treatment. The special situation of recurrence with often shorter and more
curved vein segments to be treated results in the inherent challenges of the procedure.
There are also challenges involved in the introduction of the guidewire. For example,
neovascularisations often have a weak vein wall, which is often less prominent and
much more demanding to cannulate with the patient lying down than with the patient
standing during examination. Foam sclerotherapy is sometimes a more suitable method.
Compared with that during primary treatment, the haptics during direct puncture and
cannulation, according to the Seldinger technique, at the varicose vein stump is uncommon
due to scar tissue. It is sometimes also challenging to visualise the correct catheter
placement, particularly after the insertion of tumescence. For instance, when a laser
catheter slips out during manipulation or insertion of tumescence, a new puncture
and cannulation are required; in the worst-case scenario, this cannot be performed
further in the same session due to the presence of tumescence.
With extremely diffuse or highly meandering, highly dilated recurrent varices and
extremely diffuse, disseminated varicose veins, methodical limitations depend on the
operator’s experience. In this study, other treatment methods, such as surgery or
foam sclerotherapy, can be considered.
Conclusion and outlook
Based on the available literature and guidelines, endovenous treatment of varicose
vein recurrence is possible and can be considered a valuable approach provided that
it is supported by the technical and anatomical–morphological conditions. Due to advancements
in catheter development, where the use of radial laser systems is emphasised, as well
as due to advancements in technology and user experience, the application of this
technique for varicose vein stump and neovascularisation is possible and is widespread.
However, the scientific monitoring of this exciting method appears to be limited.
This is disappointing as it limits the value of future guideline recommendations,
which should be based on evidence from studies. Thus, endovenous thermal ablation
should be further investigated for its therapeutic properties in the prevention of
complex varicose vein recurrences, preferably via high-quality prospective or comparative
studies.
The translation of this article was made possible by the kind support of the following
companies:
Bauerfeind AG
medi GmbH & Co. KG
Ofa Bamberg GmbH
Sigvaris GmbH
