Endothermal Ablation For The Treatment of Clinically Significant Incompetent Lower Limb Perforating Veins - Factors Influencing The Early Outcomes
Endothermal Ablation For The Treatment of Clinically Significant Incompetent Lower Limb Perforating Veins - Factors Influencing The Early Outcomes
Phlebology
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Endothermal ablation for the treatment ! The Author(s) 2020
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DOI: 10.1177/0268355520955085
limb perforating veins: factors influencing journals.sagepub.com/home/phl
Kenneth R Woodburn
Abstract
Background: To review the clinical experience and early outcomes of endothermal perforator ablation.
Method: Retrospective review of an endovenous practice from 2007-2019. Clinically significant incompetent perfo-
rators were treated by Endovenous Laser Ablation (EVLA), or segmental radiofrequency ablation (RFA).
Result: Complete data were available for 110 of the 116 symptomatic incompetent perforating veins treated.
Radiofrequency ablation of 20 perforators produced a 55% perforator closure rate, while 90 EVLA perforator ablations
resulted in a closure rate of 80%. Closure rates with EVLA varied by location and perforator length. Closure rates for
truncal ablation were 95.5% for RFA and 97.2% for EVLA.
Conclusion: Early closure rates following endothermal ablation of incompetent lower limb perforating veins are lower
than those obtained for truncal ablation. EVLA perforator closure appears to be more effective than segmental RFA in
most situations but short treatment lengths and location at the ankle are associated with the poorest outcomes.
Keywords
EVLA, perforator, endothermal ablation, segmental RFA
Introduction
Methods
Chronic venous insufficiency (CVI) is associated with
perforating vein incompetence, regardless of the under- A retrospective review of a single surgeon endovenous
lying aetiology1 with the incidence of perforator incom- practice was undertaken covering the period from
petence in patients with varicose veins ranging from 2007-2019 inclusive. Data were retrieved from an ano-
52% in CEAP2/3 disease to 90% in CEAP 5/6 disease.2 nymised operative logbook with additional casenote
Since treatment of incompetent perforating veins was review where required, and the study was confined to
first described,3 the results of open surgical subfascial a single treatment centre undertaking both NHS-
ligation for perforator incompetence have been associ- funded and private treatments of symptomatic lower-
ated with significant wound problems and variable suc- limb varicose veins.
cess rates.4–6 The role of subfascial endoscopic All patients underwent pre-procedure duplex venous
perforator surgery (SEPS), in the treatment of CVI mapping to exclude significant deep venous reflux, and
associated with lower limb ulceration, also remains identify sources of superficial venous reflux, carried out
unclear.7 With endothermal and other endovenous by the treating surgeon. Follow up scanning was under-
techniques being widely utilised to treat superficial taken between 6 and 16 weeks post-procedure to con-
truncal reflux, the use of these methods to treat incom- firm closure of treated segments. For the purpose of
petent perforating veins are being reported to produce
closure rates of between 54 and 90%, and ulcer healing
rates of up to 100%.8 We report on our evolving expe- Cornwall Vein Clinic, Ramsay Duchy Hospital, Truro, UK
rience and initial technical success with endothermal
Corresponding author:
ablation in the treatment of clinically significant perfo- Kenneth R Woodburn, Cornwall Vein Clinic, Ramsay Duchy Hospital,
rating vein reflux, and analyse patterns associated with Penventinnie Lane, Truro, Cornwall TR1 3UP, UK.
treatment failure. Email: [email protected]
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Table 1. Details of 1543 daycase endovenous treatments (n/a, category not applicable).
Table 2. Details of 20 perforating veins treated by segmental RFA in 18 endovenous procedures, figures in brackets represent
treatment failures.
3cm segmental RFA device (VNUS Medical) 2 (1) 7 (2) – 1 (0) 10 (3)
1cm segmental RFA device (Frontiere Medicale) 1 (1) 4 (1) 4 (3) 1 (1) 10 (6)
no anaesthesia in the case of foam sclerotherapy. Perforator lengths treated ranged from 5-60 mm,
Endothermal treatment of clinically significant perfora- with the longest median length seen in popliteal fossa
tor incompetence in patients with CEAP 4-6 disease, perforators, and the shortest in ankle perforating veins,
was attempted in 6.4% of all procedures, with most which also had the highest treatment failure (Table 3).
perforator treatments taking place at the same time All perforators over 20 mm in length treated by EVLA
as ablation of incompetent truncal veins (Table 1). In were closed at their follow up assessment between 6
all but 1 case, treatment was completed as planned. and 16 weeks post-treatment. This was not the case
In 5 perforator treatments undertaken using the for perforators treated by segmental RFA, although
ClosureRFS Stylet (VNUS Medical Technologies Inc, the failure rate for perforators over 3 cm in length
Sunnyvale, CA, USA), accurate outcome data were not was half that of shorter length perforators (Figure 2).
available, and these cases were excluded, leaving 18 Linear energy equivalent density (LEED)
procedures in which segmental radiofrequency ablation administered during treatment ranged from 62–240
was attempted on 20 incompetent perforators, with an joules/cm, with failure to close the treated
overall failure rate of 45%. Failure rate for perforators perforator being observed throughout the LEED
treated with the 1 cm segmental RF catheter, was range (Figure 3).
double that of those treated with a 3cm segmental cath-
eter (Table 2). Complications of endothermal treatments
One of the 91 perforators treated with EVLA was
lost to follow up, leaving 90 perforators, which were Thromboembolic events occurred in 3 patients follow-
treated during 75 EVLA procedures. With the excep- ing truncal endothermal ablation, but none were asso-
tion of 4 perforators undergoing redo endothermal ciated with additional perforator ablation. Persisting
treatment, all perforators were undergoing their first symptoms (beyond 3 months post-treatment) of ther-
attempt at treatment. Most procedures involved a mal saphenous or sural neuritis were reported in 11
single perforator being treated but 2 perforators were cases undergoing truncal ablation, and one case
treated at the same procedure on 14 occasions, while on occurred following ankle perforator ablation.
one occasion 3 perforators were treated. The overall In 1 patient undergoing ankle perforator ablation
closure rate for EVLA treatment of perforating veins for CEAP 6 disease a post-operative staph. aureus
was 81% (Table 3) while closure rates for truncal abla- infection was diagnosed at the perforator cannulation
tion were 95.5% for RFA and 97.2% for EVLA site, while superficial skin breakdown occurred in the
(Table 1). The mean total energy delivered to perfora- vicinity of an ankle perforator retreated with EVLA
tors that failed to close with EVLA was 178 Joules (S. and 1% foam sclerotherapy carried out with 1 part
D. 67.7J), and for successfully closed perforators it was Fibrovein (STD Pharmaceuticals, Hereford, UK)
248 Joules (S.D. 107.4J). mixed with 4 parts air. The perforator remained
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Table 3. EVLA treatments with 1470nm laser and 400l radial fibre by perforator location, length and prior treatment status, Figures
in brackets represent treatment failures.
30
Discussion
20
significantly lower than the 400 j/cm delivered to calf the perforator receiving intraluminal treatment. This
perforating veins by Proebstle,14 in a series employing may not always be readily apparent on intra-
pulsed energy delivery and achieving 100% early clo- operative ultrasound visualisation, but intraoperative
sure rates: the relatively poor results with ankle perfo- recognition of this fact is more readily apparent as an
rator closure in our series may be an indication that a increase in impedance when using the ClosureRFS
higher LEED is required to achieve perforator closure Stylet.
using a pulsed delivery method, rather than when con- Perforator treatment was carried out in more than 1
tinuous energy delivery is used. This may be particu- in 6 EVLA procedures, compared with only 1 in 40
larly relevant when treating the shorter calf and ankle RFA treatments in this series. A number of factors
perforators, as we did not observe a significant failure contributed to this difference; In the early stages of
rate in the more proximal, and longer, popliteal and our endovenous practice superficial venous incompe-
thigh perforators. It is also possible that some of the tence was treated with truncal RFA alone, as elimina-
treatment failures in this series are unrelated to the tion of truncal reflux is reported to be sufficient to
mode of energy delivery, or the LEED, and may correct any concomitant perforator reflux.19 The tech-
instead be the result of more proximal venous disease, nical skills necessary for perforator treatment evolved
as formal assessment of the iliac veins was not routinely over time, while the requirement to deliver segmental
undertaken in this study. RFA catheters via a 7Fr sheath, meant that many
The observation that failure of EVLA treatment of incompetent calf and ankle perforators that were iden-
perforators was confined to perforators where the tified, were unsuitable for cannulation and treatment
treated length was under 21 mm, may also be related with these devices. The potential risks of antegrade
to the energy delivered, as longer treatment lengths thermal conduction when using segmental RFA cathe-
result in a higher total energy delivery. Hissink ters further limited their application to perforators with
et al.16 achieved closure rates of 78% with a mean an adequate length to enable the catheter to placed at
total energy level of 187 J, while Boersma et al.10 least 1.5 cm from the junction with the deep vein and it
reported a 45% success rate with mean total energy was only with the availability of shorter length RFA
of 186 J, and 63% with 560 J. In our series the mean catheters and the acquisition of a radial firing laser that
total energy delivered to perforators that failed to close endothermal ablation of incompetent perforating veins
was a good deal lower than for perforators closed suc- became more widely applicable.
cessfully, although there was a much larger standard Undoubtedly a greater number of perforators could
deviation in the latter group. Anatomically the lowest have been treated utilising the ClosureRFS Stylet20,21
success rate was observed when treating ankle perfora- as the over-the-wire nature of this device is suited to
tors where the failure rate was around 28%. The total short perforator lengths, and our anecdotal limited
energy delivered to ankle perforators in this study was early experience with this device was favourable.
therefore likely to be lower as they were the shortest Perforator ablation with segmental RFA catheters is
perforators. not reported elsewhere and the good outcomes
Anatomical factors may also be a factor in the reported when treating incompetent perforators with
poorer outcomes observed for ankle perforators, as RFA have predominately been achieved using the
they are usually located in areas of predominately fas- now obsolete original VNUS Closure catheter,22 or
cial tissue, which has often become more fibrotic in the ClosureRFS stylet.21,23 However the ClosureRFS
response to chronic venous insufficiency and prior or stylet, which is the device most commonly employed
active ulceration. The increased fibrosis around the for perforator RFA, cannot be used to treat concomi-
ankle increases the likelihood that tumescent anaesthe- tant truncal incompetence, limiting its use to patients
sia would fail to induce significant reduction in diame- with isolated perforator incompetence, if multiple pro-
ter of the vessel to be treated and this may reduce the cedures and significant additional expense are to be
delivery of energy to the vessel wall, reducing the like- avoided. In theory, a segmental RFA catheter allows
lihood of full thickness thermal destruction,18 and per- truncal and perforator incompetence to be treated
haps favouring a transient thrombotic occlusion that, using the same device, but in our practice we found
while producing apparent closure of the perforator at that a limited number of perforators were suited to
the time of treatment, results in rapid return of reflux- this device and we could not achieve the closure rates
ing flow as recanalization occurs. Furthermore cannu- reported using the ClosureRFS stylet. In comparison,
lation of these short perforators is often difficult and it more incompetent perforators were suitable for treat-
may be that a failure to cannulate the entire treatable ment with EVLA using a 400m radial fibre, and this
length of the perforator, results in a significant propor- technique enables truncal and perforator treatment to
tion of the laser energy being delivered outside the be undertaken in a single treatment session, reducing
vessel lumen, with only the more proximal section of the costs incurred. However adopting this “single
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treatment visit” approach may lead to perforator abla- manipulating finer diameter laser fibres through tortu-
tion being undertaken when treatment of the truncal ous perforators in the relatively inelastic subcutaneous
incompetence alone may have resulted in the desired tissue associated with healed ulceration, and care needs
clinical outcome and this policy may have contributed to be taken in these circumstances.
to the much higher number of perforator treatments Some clinicians have obtained satisfactory early
observed following the introduction of the 1470 nm results treating perforators with foam sclerotherapy
laser. alone,23,24 while others,11 increased their closure rates
For both endothermal techniques (radiofrequency with EVLA using a 1470 nm laser to 96% by utilising
and EVLA) the closure rates observed following treat- foam sclerotherapy in cases where flow was still
ment of incompetent lower limb perforating veins are observed in the perforator immediately following
considerably lower than those that we obtained for EVLA. However the recanalisation rates observed
truncal ablation using the same devices, although with truncal foam sclerotherapy25 tend to cast doubt
they fall within the range of results reported else- on the long term durability of these techniques. It has
where,11,13,16,20 and are more favourable than those recently been reported that perforator closure rates in
reported for perforator treatment with foam sclerother- excess of 70% following EVLA using a 1470 nm laser
apy alone.24 These data would suggest that EVLA and 400m jacket-tip fibre, are maintained at 12
using a 1470 nm radial firing laser is more effective months13 suggesting that the lack of follow up
than segmental RFA in perforator treatment in most beyond 16 weeks in this study is unlikely to impact
locations, and enables perforators of variable length significantly on the closure rates that we observed fol-
and anatomical configuration to be treated. Over half lowing perforator EVLA.
of the perforators treated with RFA were popliteal
fossa perforators, and there was a low treatment failure
rate in this group of perforators with both RFA and Conclusions
EVLA. However attempts at RFA closure of calf and Our results confirm that EVLA of incompetent perfo-
ankle perforators met with little success, when com- rating veins using a 1470 nm radial laser is an impor-
pared with the 70% or more closure rates observed at tant technique for the endovenous surgeon to employ,
these sites following EVLA. Most calf and ankle per- and primary closure rates of 67–85% can be achieved,
forator RFA treatments were attempted with a 1cm depending on perforator location. Unlike the
catheter, and this accounts for the overall higher failure ClosureRFS Stylet, this technique enables perforating
rate observed with this RFA catheter, compared with veins to be treated at the same time as truncal incom-
the 3 cm catheter, although closure rates for the 2 cath- petence, reducing costs and hospital attendance, and a
eters were similar when treating longer, more proximal wider range of perforators can be successfully treated
perforators. However the limited applicability of these with this method, than with segmental RFA using a 1
RFA catheters resulted in only a small number of per- or 3 cm catheter. However failure rates remain higher
forators being treated with RFA in our practice. than for truncal endothermal ablation with uncertain-
The complication rate in this series, other than treat- ties around the optimal energy and the method of deliv-
ment failures, was low following perforator EVLA, ery (pulsed or continuous wave) required to maximise
despite cannulating perforators in the presence of perforator closure.
active or recently healed ulcers. While transient neuritis
is sometimes observed during treatment, or in the early Declaration of Conflicting Interests
recovery phase, in this series it was only seen to persist
The author(s) declared the following potential conflicts of
in one case, despite ankle perforators representing the
interest with respect to the research, authorship, and/or pub-
largest group undergoing treatment. The significant
lication of this article: KW is Medical Director of
complication of 400mm fibre fracture encountered in a
Valuehealthcare.uk and provides consultative advice to
patient with CEAP 5 disease undergoing attempted
Frontiere Medicale Europe.
ablation of a medial ankle perforator was investigated
under our usual governance arrangements. Detailed
Funding
inspection of the fibre in conjunction with the manu-
facturer, and analysis of the procedure itself, led to the The author(s) received no financial support for the research,
conclusion that the fracture was secondary to mechan- authorship, and/or publication of this research.
ical forces applied during attempted manipulation of
the fibre as it was repositioned in the perforator. This Ethical Approval
is a risk that operators need to be aware of when No ethical approval was needed
Woodburn 7
23. Hager ES, Washington C, Steinmetz A, et al. Factors perforator sclerotherapy for venous ulceration without
that influence perforator vein closure rates using radio- axial reflux. J Vasc Surg 2014; 59: 1368–1376.
frequency ablation, laser ablation, or foam sclerotherapy. 25. Brittenden J, Cotton SC, Elders A, et al. A randomized
J Vasc Surg Venous Lym Dis 2016; 4: 51–56. trial comparing treatments for varicose veins. N Engl J
24. Kiguchi MM, Hager ES, Winger DG, et al. Factors that Med 2014; 371: 1218–1227.
influence perforator thrombosis and predict healing with