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Comparison of Monopolar and Segmental Radiofrequency Ablation in the Treatment of Lower Limb Chronic Venous Insufficiency

Authors:
  • Woodlands Health
ARC Journal of Surgery
Volume 4, Issue 3, 2018, PP 5-10
ISSN 2455-572X
DOI: http://dx.doi.org/10.20431/2455-572X.0403002
www.arcjournals.org
ARC Journal of Surgery Page |5
Comparison of Monopolar and Segmental Radiofrequency
Ablation in the Treatment of Lower Limb Chronic Venous
Insufficiency
Jun-Yi Ryan TAN, Zhiwen Joseph LO, Pravin LINGAM, Qiantai HONG, Enming YONG,
Sadhana CHANDRASEKAR, Glenn Wei Leong TAN
Vascular Surgery Service, Department of General Surgery, Tan Tock Seng Hospital, Singapore
1. INTRODUCTION
Chronic venous insufficiency (CVI) is a
prevalent issue, affecting an average of 10-15%
of men and 20-25% of women worldwide1.
Surgical treatment of lower limb CVI has
progressed greatly since the days of open ligation
and stripping to more minimally invasive
procedures such as foam sclerotherapy and most
recently endothermal ablation technologies such
as endovenous laser therapy (EVLT) and
endovenous radiofrequency ablation (RFA)2.
EVLT and RFA have recently been
recommended as first-line interventions for CVI
by 2013 NICE guidelines3 and have been shown
to be superior to open surgery and foam
sclerotherapy4. 4 main RFA systems are available
commercially Covidien ClosureFast™
(Medtronic, USA), EVRF® (F Care Systems,
Belgium), RFiTT® (Celon AG, Germany) and
VeinClear™ (RF Medical, South Korea).
Covidien ClosureFast™, a segmental RFA
system, and EVRF®, a monopolar RFA system,
have both been shown to be safe and efficacious5,
6. However, a recent 2015 meta-analysis on the 4
commercially available RFA systems revealed
far fewer publications7 on EVRF® data as
compared to Covidien ClosureFast™, with no
previous direct comparisons of the monopolar
and segmental systems. As such, in our study we
aim to bridge this gap in existing knowledge by
comparing the outcomes in patients with lower
limb CVI treated with monopolar (EVRF®, F
Care Systems, Belgium) versus segmental
(Covidien® ClosureFast™, Medtronic, USA)
radiofrequency ablation (RFA) therapy.
*Corresponding Author: Zhiwen Joseph LO, Vascular Surgery Service, Department of General Surgery,
Tan Tock Seng Hospital,11 Jalan Tan Tock Seng, Singapore , Email: zhiwen@gmail.com
Abstract
Introduction: There are 4 commercially available RFA systems for endovenous ablation of lower limb varicose
veins. We aim to compare outcomes in patients with chronic venous insufficiency treated by monopolar
(EVRF®, F Care Systems, Belgium) and segmental (ClosureFast™, Medtronic, USA) radiofrequency ablation
(RFA)
Methods: Retrospective review of 288 limbs (189 patients) treated from 20142015, evaluating demographics,
comorbidities, venous disease grading, pre-operative venous duplex, surgical procedure and post-operative
outcomes.
Results: 146 limbs were treated by monopolar RFA, 142 limbs by segmental RFA. Both groups were similar in
patient characteristics. In addition to long saphenous vein ablation, anterior accessory great saphenous vein
(AAGSV) (monopolar: 20%, segmental: 10%, p=0.01) and short saphenous vein RFA (monopolar: 14%,
segmental: 8%, p=0.14) were performed. Post-operative outcomes were similar in both groups. Transient
superficial neuropathy was 8% in both groups (p=0.83), phlebitis occurred in 4% of monopolar group and 1%
of segmental group (p=0.28). No deep vein thrombosis nor recurrences occurred.
Conclusion: Both monopolar and segmental RFA are safe and efficacious. The shorter ablation tip of
monopolar RFA enables the ease for ablation of shorter veins, such as the AAGSV.
Keywords: Endovenous Radiofrequency Ablation, Varicose Veins, Chronic Venous Insufficiency, Anterior
Accessory Great Saphenous Vein
Comparison of Monopolar and Segmental Radiofrequency Ablation in the Treatment of Lower Limb
Chronic Venous Insufficiency
ARC Journal of Surgery Page |6
2. METHODS
2.1. Study Design
This study was a retrospective analysis of a total
of 288 limbs treated with endovenous RFA from
January 2014 to May 2015 at a 1,500-bed tertiary
referral university hospital. Factors investigated
included patient demographics, co-morbidities,
venous disease clinical manifestation (CEAP
Classification), pre-operative venous duplex
mapping, surgical procedure and post-operative
outcomes. Patient co-morbidities were
determined by American Society of
Anaesthesiologists (ASA) Classification,
smoking history, type 2 diabetes mellitus and
control, peripheral arterial disease and previous
venous surgery.
All patients were encouraged to undergo a trial of
lifestyle modification and graduated compression
stockings before surgical intervention. Patients
with C6 venous disease were treated with 4-layer
compression bandaging to promote ulcer healing
prior to any surgical intervention. The decision
for treatment with segmental or monopolar RFA
was based on surgeon’s preference. All
procedures were carried out by trained consultant
vascular surgeons who were experienced and
proficient in both systems.
Pre-operatively, patients routinely underwent
venous duplex mapping at our local vascular
diagnostic laboratory by trained vascular
scientists according to Society of Vascular
Ultrasound guidelines, using Philips iU22
ultrasound machines (Philips, USA). Sapheno-
femoral junction (SFJ) incompetence, great
saphenous vein (GSV) reflux, sapheno-popliteal
junction (SPJ) incompetence, short saphenous
vein (SSV) reflux and deep venous reflux were
assessed in the venous duplex mapping. Anterior
accessory great saphenous vein (AAGSV)
incompetence is also evaluated as part of the
diagnostic protocol.
2.2. Devices and Technique
All cases were carried out under general or
regional anaesthesia, with no routine intravenous
pre-operative antibiotics or pharmacological
deep vein thrombosis prophylaxis given.
Ultrasound-guided venous punctures were
performed with Philips iU22 ultrasound
machines (Philips, USA). Access was achieved at
below knee GSV under ultrasound guidance with
a 21G needle, after which a 7F sheath was
inserted using the Seldinger technique and
flushed with heparinised saline. Tumescent
anaesthesia (480ml of saline mixed with 20ml
1% lignocaine, 16ml 8.4% sodium bicarbonate
and 60 units 1:1000 adrenaline) was administered
prior to endovenous ablation. Intra-operatively,
ablation of the AAGSV would be attempted if
reflux were found, while SSV reflux was treated
only with the concomitant presence of SPJ
incompetence.
In the monopolar group, the EVRF® RFA
system (F Care Systems, Belgium) with the
CR45i catheter were used for ablation. The
CR45i catheter delivers power of up to 25W and
has an active catheter tip of 0.5cm. The CR45i
catheter was inserted and positioned 2cm from
the SFJ. Ablation of the GSV was carried out at
25W within the fascia envelope and at 22W when
not enveloped by fascia. A pull-back technique
was employed for ablation and the pull-back rate
was 0.5cm (1 marking) every 3 beeps (5-
6seconds) as per manufacturer instructions for
use.
In the segmental group, the ClosureFast™
system (Medtronic, USA) was used with a
ClosureFast™ Endovenous RFA catheter and
ClosureRFG™ radiofrequency generator. The
ClosureFast™ catheter has a 3cm or 7cm active
catheter tip and in view of financial
considerations, only 1 is utilized for each patient.
The ClosureFast™ catheter was inserted and
positioned 2cm distally from the SFJ. Ablation
was carried out in 20-second cycles from 40W
(120˚C) to 10W. Two cycles were applied for the
initial 7cm segment and one cycle per segment
subsequently. The catheter was pulled back at
2.5cm or 6.5cm intervals after each ablation cycle
to allow for a 0.5cm segment of overlap, as per
manufacturer guidelines.
All patients had an on-table ultrasound post-
procedure to ensure complete ablation of GSV
and to ensure the absence of deep vein
thrombosis within the femoral vein. All
procedures were completed with stab avulsion
phlebectomies. Incision sites were closed with
Steri-Strips™ (3M, USA) and dressed with 3M
Coban™ 2 Layer Compression bandage (3M,
USA). This bandage would be removed on post-
operative day 1, exchanged for a light-weight
stocking TubigripTM (Molnlycke Health Care,
Sweden) and continued until review in clinic.
Oral paracetamol or non-steroidal anti-
inflammatory drugs were prescribed for post-
operative analgesia. Patients were reviewed in
clinic 6 weeks post-operatively and assessed
clinically for symptoms of complications such as
Comparison of Monopolar and Segmental Radiofrequency Ablation in the Treatment of Lower Limb
Chronic Venous Insufficiency
ARC Journal of Surgery Page |7
transient neuropathy, phlebitis, deep venous
thrombosis and clinical recurrences. Repeat
ultrasound venous duplex mapping will be
performed should there be any suspicion for
clinical recurrences.
2.3. Statistics
Factors investigated were evaluated using
descriptive statistics. Percentages were used for
categorical data and means for continuous data.
Comparisons between groups for categorical data
were made using Chi-square tests, while
comparisons made between continuous data were
made with the Student’s t-test. All p values were
2 tailed and p values ≤0.05 were considered
statistically significant. SPSS 13.0 (Illinois,
USA) was used for statistical analysis.
3. RESULTS
From January 2014 to May 2015, 189 patients
(288 limbs) were treated with endovenous
radiofrequency ablation at our institution (Table
1). There was an equal distribution between both
treatment modalities, with 146 limbs treated with
monopolar RFA and 142 limbs treated with
segmental RFA. Of these, 55 patients (110 limbs)
of the monoplar group and 44 patients (88 limbs)
of the segmental group had bilateral chronic
venous insufficiency that was treated.
Both groups were largely similar in terms of
patient demographics and comorbidity profile
(Table 1). The mean age of our patients was 58
(27 83) years while the mean Body Mass Index
was 26.3 (16.6 45.1) kg/m2. Of the 288 limbs
treated, 174 were female while 114 were male.
Majority of patients were of American Society of
Anesthesiologists (ASA) Class I and II (92% in
monopolar and 83% in segmental) while we had
few smokers (27% in monopoolar and 18% in
segmental) and Type 2 diabetics (10% in
monopolar and 18% in segmental). Significantly,
no patients had concomitant arterio-venous
disease. Minority had undergone previous
venous surgery (5% in monopolar and 3% in
segmental).
In terms of pre-operative CEAP venous disease
manifestation (Table 2), within the monopolar
group patients with C2-C5 disease were 29%,
2%, 36%, 23%, 10% respectively. Similarly in
the segmental group, patients with C1-C6 disease
were 4%, 19%, 6%, 32%, 26% and 13%
respectively. On pre-operative venous duplex
scanning, all limbs treated had GSV reflux,
majority had SFJ incompetence (88% in
monopolar, 80% in segmental, p=0.07) while
half had SSV reflux (51% in monopolar and 49%
in segmental, p=0.73) and a third had
concomitant deep venous reflux (29% in
monopolar and 34% in segmental, p=0.38).
There was a significant difference between the
veins ablated in both groups. All patients
underwent LSV radiofrequency ablation.
However, in addition to LSV RFA, there were
significantly far more in the monopolar group
that had undergone AAGSV ablation as
compared to the segmental group (Table 3). 29
(20%) limbs in the monopolar group underwent
AAGSV ablation as compared to only 4 (3%) in
the segmental group and this was found to be
statistically significant by chi squared analysis
(p=0.01). A similar trend is seen in SSV
ablations, with 21 (14%) ablated in the
monopolar group compared to 12 (8%) in the
segmental group. Almost all patients underwent
phlebectomies, 144 (99%) in the monopolar
group and 139 (98%) in the segmental group.
Post-operative complications were few and there
were no statistical differences between both
groups. There were 11 (8%) limbs with transient
neuropathy in the monopolar group and 12 (8%)
in the segmental group. None of the patients
developed permanent neuropathy. There were 6
(4%) with phlebitis in the monopolar group
compared to 2 (1%) in the segmental group.
There were significantly no incidences of deep
venous thrombosis or clinical recurrences within
both groups (Table 3).
Table1. Patient characteristics
p value
(Chi-
squared)
Demographics Male : Female
Average age (range)
Average BMI (range)
0.15
0.62*
0.34*
Ethnicity Chinese
0.79
Comparison of Monopolar and Segmental Radiofrequency Ablation in the Treatment of Lower Limb
Chronic Venous Insufficiency
ARC Journal of Surgery Page |8
Indian
Malay
Others
1.00
0.81
0.81
Treated Limbs Right : Left
Bilateral
1.00
0.02
Co-morbidities ASA Classification 1
ASA Classification 2
ASA Classification 3
Smoker
Type 2 diabetes mellitus
Good DM Control (HbA1c ≤ 7%)
Peripheral arterial disease
Previous venous surgery
0.13
0.01
0.03
0.07
0.06
0.04
N.A.
0.38
*Unpaired T-test ASA: American Society of Anaesthesiologists; BMI: body mass index; DM: Diabetes Mellitus;
RFA: Radiofrequency Ablation
Table2. Venous Disease
p value
(Chi-
squared)
Venous Disease
Clinical Manifestation (CEAP) 1
2
3
4
5
6
0.03
0.04
0.08
0.62
0.58
0.58
Pre-op Venous Duplex
SFJ incompetence
LSV reflux
SPJ incompetence
SSV reflux
Deep veins reflux
0.07
1.00
0.01
0.73
0.38
AAGSV: anterior accessory great saphenous vein; LSV: long saphenous vein ; RFA: radiofrequency ablation ;
SFJ: sapheno-femoral junction ; SPJ: sapheno-popliteal junction ; SSV: short saphenous vein
Table3. Surgical Procedure and Post-operative Complications
p value
(Fisher’s 2-
tailed)
Surgical Procedure
AAGSV ablation
SSV ablation
SPJ ligation
Phlebectomy
0.01
0.14
N.A.
0.68
Post-op Outcomes
Transient neuropathy
Permanent neuropathy
Phlebitis
DVT
Recurrence
0.83
N.A.
0.28
N.A.
N.A.
AAGSV: anterior accessory great saphenous vein; DVT: deep vein thrombosis; LSV: long saphenous vein ; RFA:
radiofrequency ablation ; SPJ: sapheno-popliteal junction ; SSV: short saphenous vein
Comparison of Monopolar and Segmental Radiofrequency Ablation in the Treatment of Lower Limb
Chronic Venous Insufficiency
ARC Journal of Surgery Page |9
4. DISCUSSION
Within the literature, this is the first study which
directly compared monopolar and segmental
radiofrequency ablation for lower limb CVI. Our
study is also the largest series of monopolar
radiofrequency ablation for lower limb CVI
within Asia. The most significant finding of our
study was that more short vein ablations, such as
AAGSV ablations, were carried out with the
monopolar system. The AAGSV was ablated in
20% of ablations carried out in the monopolar
group as compared to only 3% in the segmental
group. This is likely a result of the shorter, 0.5cm
active catheter tip of the of the monopolar
EVRF® system, which has a 0.5cm active
catheter tip as compared to the 3cm or 7cm active
catheter tip of the ClosureFast™ catheter. In
current literature, there is a low reported rate of
AAGSV ablations in most studies5, 8, ranging
from 2.7% - 10% in various studies on
endothermal ablation. Ablation of the AAGSV is
not well studied although incidence of isolated
AAGSV reflux has been reported at 10%9 and its
clinical significance has been suggested in its
role in causing recurrence after GSV ablation or
stripping10-12 although currently, there is no
consensus on its treatment, even in the absence of
reflux.
Similarly, in our study we saw a similar trend in
more SSV ablations carried out in the monopolar
group (14%) as compared to the segmental group
(8%), and this is consistent with that described in
existing literature in a 2015 study on the
monopolar system by Spiliopoulos et al5 14.8%
of procedures involved ablation of the SSV,
while only 5% were ablated in a 2015 segmental
study13.
Our study’s findings also further reiterate the
safety and efficacy of radiofrequency ablation as
a treatment modality for lower limb CVI,
demonstrating favourable surgical outcomes with
low rates of post-operative complications in both
the segmental and monopolar groups with no
significant differences between both groups. Our
study had no incidences of deep venous
thrombosis and clinical recurrences, which is in
keeping with existing literature that shows a <1%
risk of deep venous thrombosis14. In our series
there was a 2.7% incidence of post-operative
phlebitis, in keeping with current reported
literature of 0.8 5.5%6, 15. However, although
our study reported a low rate of 8% incidence of
transient neuropathy in both groups, existing
literature has reported slightly lower rates of
post-operative transient neuropathy, with 3-5%
and 2% reported in segmental6, 15, 16 and
monopolar5 studies respectively. Notably none of
the incidences of transient neuropathy were
permanent in our study and in reported literature.
A possible explanation for the slightly higher
incidence in transient neuropathy in our series,
although still low, compared to that of existing
literature could be in the ethnic differences in our
patients, with 71.5% of Chinese descent, which
has anecdotally been associated with a higher
incidence of incomplete fascial covering over the
GSV.
Limitations of our study include the retrospective
nature of our study design, with its associated
selection and information biases. In terms of
chronic venous insufficiency grading, we
adopted the CEAP classification and did not use
the venous severity score. Post-operative
recurrences were evaluated clinically, with no
formal surveillance ultrasound venous duplex.
We also were not able to compare the efficacy of
the other 2 endovenous radiofrequency ablation
devices on the market.
5. CONCLUSION
Both monopolar and segmental RFA are safe
endovenous modalities in the treatment of lower
limb CVI, with similar clinical outcomes and low
complication rates. The significant advantage of
monopolar over segmental RFA would be its
shorter active catheter tip of 0.5cm, which
enables the ease for ablation of shorter veins,
such as the AAGSV.
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Citation: Jun-Yi Ryan TAN, Zhiwen Joseph LO, Pravin LINGAM, Qiantai HONG, Enming YONG, Sadhana
CHANDRASEKAR, Glenn Wei Leong TAN. Comparison of Monopolar and Segmental Radiofrequency Ablation
in the Treatment of Lower Limb Chronic Venous Insufficiency.ARC Journal of Surgery.2018;4(3):5-
10.doi:dx.doi.org/ 10.20431/ 2455-572X. 0403002.
Copyright: © 2018 Authors. This is an open-access article distributed under the terms of the Creative Commons
Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited.
Article
Objective To investigate and compare the outcomes of the available treatment modalities for anterior accessory saphenous vein (AASV) incompetence. Methods A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies reporting the outcomes of patients who were treated for primary AASV incompetence were included. The methodologic quality of the articles was assessed using the Methodological Index for Non-Randomized Studies (MINORS). A random-effects model was used to estimate anatomic success, defined as AASV occlusion. The secondary outcomes were pain during and after treatment, venous clinical severity score, quality of life, esthetic result, time to return to daily activities, and complications. Results The search identified 860 articles, of which 16 met the inclusion criteria. A total of 609 AASVs were reported. The included studies were of poor or moderate quality according to MINORS score. The pooled anatomic success rates were 91.8% after endovenous laser ablation and radiofrequency ablation (EVLA, RFA, 11 studies), 93.6% after cyanoacrylate closure (3 studies), and 79.8% after sclerotherapy (2 studies). The non-pooled anatomic success rate was 97.9% after phlebectomy and 82% after CHIVA. Paresthesia was seen after EVLA in 0.7% of patients (6 studies). Phlebitis was seen in 2.6% of patients after RFA (2 studies), 27% after sclerotherapy (1 study), and 12% after the phlebectomy (1 study). Deep venous thrombosis and skin burn did not occur. Conclusion Treatment of AASV incompetence is safe and effective. Despite limited evidence, occlusion of the AASV can be achieved with endovenous thermal ablation and cyanoacrylate. There does not appear to be a benefit of EVLA compared to RFA regarding treatment efficacy. Phlebectomy shows promising results if the saphenofemoral junction is competent. Lower results are seen after sclerotherapy and CHIVA. However, studies with sufficient sample sizes of solely treatment of AASV incompetence are needed to draw firm conclusions.
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This is a prospective trial investigating endovenous radiofrequency ablation with the EVRF® system for the treatment of symptomatic varicose veins. Primary endpoints include one-year anatomical and clinical success and procedure-related complications. Secondary endpoints include adjunctive procedures and recanalization rates, periprocedural pain assessment, and time return to normal activities. In 60 patients with 74 limbs, 58 great saphenous vein, 11 small saphenous vein, 2 anterior accessory saphenous vein, and 3 perforators were ablated. Additional ablations for further improvement were necessary in 28.4%. Clinical success was 94.6%. Anatomical success was 96.0% at one month and 89.2% at one year. Primary ablation success was 77%. Revascularization occurred in 12.1%. Clinically driven repeat ablation rate was 4.0%. Perforator ablation due to segmental revascularization was performed in 5.4%. Complications included one puncture-site infection, three scars, two cases of transient paresthesia, and one skin pigmentation. Periprocedural mean pain score was 2.4 ± 2.6. In 27.0% cases, the patients used analgesics and mean time return was 1.2 ± 0.5 days. The EVRF® system yields satisfactory clinical and anatomical midterm outcomes with very low complication rates. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
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. The goal of this retrospective cohort study (REVATA) was to determine the site, source, and contributory factors of varicose vein recurrence after radiofrequency (RF) and laser ablation. Methods . Seven centers enrolled patients into the study over a 1-year period. All patients underwent previous thermal ablation of the great saphenous vein (GSV), small saphenous vein (SSV), or anterior accessory great saphenous vein (AAGSV). From a specific designed study tool, the etiology of recurrence was identified. Results . 2,380 patients were evaluated during this time frame. A total of 164 patients had varicose vein recurrence at a median of 3 years. GSV ablation was the initial treatment in 159 patients (RF: 33, laser: 126, 52 of these patients had either SSV or AAGSV ablation concurrently). Total or partial GSV recanalization occurred in 47 patients. New AAGSV reflux occurred in 40 patients, and new SSV reflux occurred in 24 patients. Perforator pathology was present in 64% of patients. Conclusion . Recurrence of varicose veins occurred at a median of 3 years after procedure. The four most important factors associated with recurrent veins included perforating veins, recanalized GSV, new AAGSV reflux, and new SSV reflux in decreasing frequency. Patients who underwent RF treatment had a statistically higher rate of recanalization than those treated with laser.
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Scope of the review: This article systematically reviews the practice of radiofrequency ablation of lower limb varicose veins. We present the clinical evidence and best practice techniques for currently available devices. Methods: Manufacturer's instructions-for-use were requested for all radiofrequency devices. The MEDLINE and EMBASE databases were searched using the following keywords: 'varicose veins' AND 'radiofrequency' OR 'radio frequency' OR 'Venefit' OR 'ClosureFAST' OR 'RFiTT' OR 'EVRF' OR 'VeinCLEAR', generating 240 articles. Titles and abstracts were screened, yielding 63 articles directly relevant to the scope of the review. Reference lists for publications were also searched to identify further manuscripts of relevance. The Cochrane Database and current National Institute for Clinical and Healthcare Excellence guidelines for varicose veins were also searched from relevant articles. Results: Four radiofrequency ablation (RFA) systems are currently commercially available. Generic practice methods (common to all RF systems) and device-specific techniques are described. The weight of current evidence relates to the use of Covidien Venefit™ (formerly VNUS ClosureFAST™), which clearly demonstrates clinical advantages over open surgery at least to 2 years follow up. However, contemporary studies of the radiofrequency-induced thermal therapy device (RFiTT®), show that in experienced hands, clinical equivalence to the Venefit™ procedure can be achieved. The evidence base for EVRF® and VeinCLEAR™ devices is currently weak and absent, respectively. Conclusions: Despite widespread uptake of RFA and acceptance of its clinical advantages over open surgery there is a paucity of Class 1 A evidence. This results from incongruent reporting of clinical outcome measures within existing literature. Similarly, lack of long-term follow-up studies precludes comparison of the durability of short- and medium-term advantages of RFA with the longer term results of open surgery. There remains scope for a large prospective high-quality trial to assess the clinical, anatomical and cost-effectiveness outcomes for the four commercially available RFA devices, with a particular focus on long-term follow up.
Article
Objective Endothermal ablation has become a commonly used technology for occlusion of refluxing great saphenous veins (GSVs). However, the risk for primarily untreated accessory saphenous veins (ASVs) to develop reflux during follow-up has not yet been defined. Here, the prevalence and risk of ASV reflux is explored. Methods During a prospective multicenter cohort study on radiofrequency segmental thermal ablation of refluxing GSVs, the presence and reflux status of ASVs were monitored in 93 legs in a single center. Control examinations were performed after 1 week and at 12, 24, 36, and 48 months. Life-table and multiple regression analyses were used to describe frequency and risk factors for presence of reflux in untreated ASVs. Results Of 93 legs, 82 (88%) were available for 4-year follow-up. At baseline, 43 legs (46%) had an anterior ASV detectable by duplex ultrasound, with only two legs (2%) presenting with reflux. During 4 years of follow-up, according to life-table analysis, the proportion of legs with a detectable anterior ASV increased to 71% (n = 65); 32% of all legs and 55% of legs with a detectable anterior ASV exhibited refluxing anterior ASVs. Remarkably, in 35% of all legs with an anterior ASV, this reflux presented as a source of axial reflux, suggesting hemodynamic relevance. Posterior ASVs were detected in only 10 legs during 4-year follow-up, exhibiting reflux in only two cases. Conclusions Whereas posterior ASVs were meaningless, refluxing anterior ASVs occurred in a significant proportion of legs after thermal ablation of GSVs. Whether nonrefluxing anterior ASVs should be treated at the time of GSV ablation needs further examination.
Article
Introduction Endogenous radiofrequency ablation (RFA) is a proven treatment for varicose veins that has equal efficacy to surgical stripping. It offers the benefit of reduced post operative pain and wound infection and quicker return to work. Aim To carry out a clinical audit of patients undergoing RFA to monitor outcomes, complication rates, follow-up sclerotherapy and to assess the need for post-operative duplex scan. Methods A retrospective analysis was performed of 174 procedures carried out from January 2011 to March 2012. Patients were pre-assessed with history, physical exam and duplex ultrasound. They were followed up at 3 months with same. CEAP classification was applied to check for post-operative improvement. Results 174 procedures, including 165 great saphenous vein and 9 short saphenous vein ablations were carried out on 154 patients. The duplex occlusion rate at 3 months was 99 %. 141 patients (81 %) showed a reduction in CEAP score with average CEAP decreasing from 2.37 to 0.96. Overall the complication rate was low at 7 %. Paraesthesia was the most common complication with 7 cases (4 %). There were no DVTs. 45.4 % of patients went on to have follow-up sclerotherapy for venous flares. Conclusion RFA is a safe and effective treatment for varicose veins. There is no benefit in performing routine short term follow-up duplex scan due to the high occlusion rates.
Article
Background Endovenous ablation (EVA) of the great saphenous vein (GSV), with radiofrequency (RFA) or laser ablation (EVLA), has largely replaced the standard ligation and stripping (L&S). Several randomized controlled trials (RCTs) have reported data on efficacy of the ablation with little focus on complications. We analyzed the current literature for short-term complications of EVA as compared with L&S. Methods We searched MEDLINE, the Cochrane Central Trials Registry, and individual journals from January 2008 through January 8, 2013 for RCTs comparing RFA and/or EVLA and/or L&S to treat GSV incompetence. We excluded studies using foam sclerotherapy, re-do GSV surgery, or the addition of a high GSV ligation to an EVA procedure. We meta-analysized short-term (<1 year) complications using the Peto odds ratio to elucidate differences between RFA (using the VNUS ClosureFAST catheter; VNUS Medical Technologies, Inc, San Jose, Calif), EVLA, and L&S. Results Seventeen RCTs met inclusion criteria. There were 317 patients who underwent RFA with ClosureFAST, 1057 patients who had EVLA, and 975 who had L&S. Seventy percent were female with a mean age of 47.5 years. The majority had CEAP clinical class 2 or 3. There was an overall complication rate of 39.6% in the 2624 limbs analyzed over all procedures. There was no evidence of a difference in the rates of venous thromboembolism. There was a significantly higher rate of wound infection for L&S (2.3%; 95% confidence interval [CI], 1.3%-3.1%) vs EVLA (0.5%; 95% CI, 0.3%-1.3%; P = .006), but not between L&S and RFA (1.5%; 95% CI, 0.4%-3.0%; P = .094). The paresthesia rate was significantly lower with EVLA (3.8%; 95% CI, 2.4%-4.5%) as compared with RFA (5.2%; 95% CI, 3.1%-7.9%; P < .001) and L&S (7.4%; 95% CI, 5.3%-8.3%; P < .001). The rate of thrombophlebitis was significantly lower for L&S (3.0%; 95% CI, 2.9%-4.0%) as compared with RFA (5.5%; 95% CI, 3.0%-7.8%; P = .003) and EVLA (5.6%; 95% CI, 4.2%-7.0%; P = .003). There was no difference in the rate of thermal skin burns between RFA and EVLA. Conclusions Endovenous ablation and ligation and stripping of the GSV are not without complications, although usually minor. L&S has a higher wound infection rate and a lower thrombophlebitis rate as compared with EVA. EVLA has a significantly lower rate of paresthesia as compared with RFA and L&S. Thermal skin burns occur with equal frequency in RFA and EVLA.
Article
The aim of this study is to report our results in main stem vein closure using the bipolar radiofrequency induced thermotherapy (RFITT) system and the 1064 nm Nd:Yag laser. 44 incompetent main stem veins (37 great saphenous veins, one lesser saphenous vein, and 6 anterior accessory saphenous veins) in 29 patients were treated using RFITT. 53 incompetent main stem veins (45 great saphenous veins, 4 lesser saphenous veins, and 4 anterior accessory saphenous veins) in 43 patients were treated endovenously with 1064 nm Nd:Yag laser. All patients underwent postoperative duplex scanning within a month after procedure, as well as a short interview regarding postoperative discomfort. In main stem veins treated with RFITT, the success rate within the first month was 86,4 % (38 out of 44 veins). Complete failure rate was 13,6 % (6 out of 44 veins). In 53 main stem veins treated by 1064 nm Nd:Yag laser, the success rate was 100 %, consisting of 98,1 % complete success (52/53 veins), and 1,9 % partial success (1/53 veins). None of the patients treated with RFITT experienced postoperative adverse effects, whereas 13/43 (30,2 %) patients treated with laser had to use oral analgesics after the treatment, and 21/43 (48,8 %) patients reported transient skin changes, such as bruising or skin redness. RFITT system was fairly efficient in the short term for closure of main trunk veins, whereas longer term results are still scarce. Postoperative side effects of RFITT were minimal. 1,064 nm Nd:Yag laser, according to short term results, proved to be very effective for main stem vein closure. Postoperative side effects related to 1064 nm Nd:Yag endovenous laser treatment proved to be minor, transient, and acceptable.
Article
Deep vein thrombosis (DVT) after varicose vein surgery is well recognised. Less well documented is endovenous heat-induced thrombosis (EHIT), thrombus extension into a deep vein after superficial venous thermoablation. We examined the rates of DVT in our unit after radiofrequency (RFA) and endovenous laser ablation (EVLA) with specific attention to thrombus type. Retrospective analysis of all cases of RFA under general anaesthesia and EVLA under local anaesthesia was performed. Cases of DVT were identified from the unit database and analysed for procedural details. In total, 2470 cases of RFA and 350 of EVLA were performed. Post-RFA, DVT was identified in 17 limbs (0.7%); 4 were EHIT (0.2%). Concomitant small saphenous vein (SSV) ligation and stripping was a risk factor for calf-DVT (OR 3.4, 95%CI 1.2-9.7, P=0.036), possibly due to an older patient group with more severe disease. Post-EVLA, 4 DVTs were identified (1%), of which 3 were EHIT (0.9%). The DVT rate including EHIT was similar in patients treated with RFA and EVLA and was low. Routine post-operative duplex ultrasound scanning is recommended until the significance of EHIT is better understood, in accordance with consensus guidelines. DVT rates for both techniques compare favourably with those published for saphenous vein stripping.
Article
Varicose veins are as old as Hippocrates. Varicose vein treatments come and go. Surgery for varicose vein disease is one of the commonest elective general surgical procedures. The history of varicose vein surgery has been traced. We note the first descriptions of varicose veins, and we particularly focus on the ligation of the saphenofemoral junction, stripping of the great saphenous veins, phlebectomy, and perforant vein surgery. We end with the rapid rise of minimally invasive procedures, such as foam sclerotherapy, radiofrequency ablation, and endovenous lasertherapy. Within 10 years, the advantages of minimal invasiveness for these procedures, combined with claims of equivalent short-term outcomes and even better long-term results, have already influenced our everyday practice. At present, the gold standard treatment of varicose veins still is surgical ligation and stripping of the insufficient vein. Concomitantly or sequentially with the treatment of truncal insufficiency, residual varicosities can be treated by phlebectomy. New minimally invasive techniques, however, have changed the clinical landscape for varicose vein surgery tremendously. The dramatic changes of the last decade are probably the precursors of the next generation.
Article
This prospective and multicenter study shows the results at 1 year of radiofrequency-powered segmental thermal obliteration (RSTO) carried out with the ClosureFast procedure. The RSTO clinical and duplex ultrasound imaging results were evaluated at 3 days, 3 months, 6 months, and 1 year. All procedures were carried out on outpatients under tumescent local anesthesia. Among the 295 members who were treated, 289 were reexamined at 3 days, 290 at 3 months, 289 at 6 months, and 220 at 1 year. Occlusion scores were 99.7%, 99.3%, 98.6%, and 96.9% at, respectively, 3 days, 3 months, 6 months, and 1 year. At 3 cm below the saphenofemoral junction, before the procedure, the greater saphenous vein (GSV) diameter was 5.4+/-2 mm (range 2-18). It decreased to 4.5+/-1.7 mm at 3 days, 2.4+/-1.5 mm at 6 months, and 1.3+/-0.9 mm at 1 year. In members reexamined at 1 year, the decrease in diameter of the treated vein compared with the preprocedural measurement was 79% (p<0.001, t-test). At 1 year, in 58% of the cases, duplex ultrasound imaging at mid-thigh level could not show the GSV trunk. Preprocedural pain that was present in 57.5% of the cases decreased to 10.8% of the cases at 3 days and 2% of the cases at 1 year (p<0.001, chi2 test). Among the treated limbs, 70.1% did not present with any postprocedural pain at any time of the follow-up. On the third day, the patients evaluated the mean pain intensity at 0.7+/-1.6 on a visual analog scale of 0-10. During the follow-up, no painful indurations were noticed in 67.7% of the legs. No thromboembolic complications were reported. Paresthesias were observed in 3.4% of the cases. Invalidity clinical score, evaluated at 3.9+/-2 before the procedure, decreased to 3.5+/-1.2 on the third day, 0.9+/-1.5 at 3 months, 0.7+/-1.2 at 6 months, and 0.5+/-1.1 at 1 year. This study confirms the efficacy of RSTO when using ClosureFast, which allows obliteration of the GSV trunk in 97% of cases at 1 year with few side effects and almost no postprocedural pain.