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Endovenous radiofrequency ablation for the treatment of varicose veins

Authors:

Abstract

Varicose veins are a common condition that can be treated surgically. Available operative modalities include saphenous venous ligation and stripping, phlebectomy, endovenous laser therapy and radiofrequency ablation. Radiofrequency ablation is the newest of these technologies, and to our knowledge our group was the first to use it in Canada. Our experience suggests that it is a safe and effective treatment for varicose veins, with high levels of patient satisfaction reported at short-term follow-up. More studies are needed to assess long-term effectiveness and compare the various available treatment options for varicose veins.
COMMENTARY • COMMENTAIRE
©2015 8872147 Canada Inc. Can J Surg, Vol. 58, No. 2, April 2015 85
Endovenous radiofrequency ablation for the
treatment of varicose veins
V
aricose veins affect approximately 26% of the adult population and are
a frequent cause of discomfort, loss of productivity and deterioration
in health-related quality of life.
1
Numerous therapies have been
de veloped for the treatment of this condition. Conventional open surgical
interventions include ligation of the great saphenous vein at the saphenofem-
or al junction and stripping. Smaller veins have also been treated with phlebec-
tomies. More recently, less invasive modalities, such as foam sclerotherapy,
endovenous laser therapy (EVLT) and endovenous radiofrequency ablation
(RFA), have also been used. While endovenous approaches are associated with
fewer postoperative complications, such as hematoma, pain or saphenous
nerve injury, there is currently no strong evidence to suggest an overall advan-
tage for any particular treatment approach.
2
The RFA procedure involves using a catheter electrode to deliver a high-
frequency alternating radiofrequency current that leads to venous spasm, col-
lagen shrinkage and physical contraction.
3
The patient’s leg is prepped with
antiseptic solution and draped in a sterile fashion. With ultrasound guidance,
the vein is cannulated, and local tumescent anesthetic is then injected around
the target venous segment. The catheter is then introduced through a sheath.
The radiofrequency current is then delivered, resulting in circular homogen-
eous denaturation of the venous collagen matrix and endothelial destruction at
a temperature of 110–120° C. Venous segments 3–7cm in length are treated
in 20-second cycles. Patients are instructed to wear 20–30 mm Hg graduated
elastic compression stockings for at least 14 days.
Compared with conventional open surgery, RFA can be performed in the
outpatient setting without the requirement for hospital admission or general
anesthesia. However, the procedure is not feasible in tortuous or very small or
large veins, and it may be less cost-effective than open surgery because of the
cost of the catheters.
To our knowledge, our institution was the rst in Canada to offer RFA for
the management of varicose veins using the venet procedure with second-
generation ClosureFast catheters (Covidien). Between 2010 and 2013,
173pa tients underwent RFA performed by 3 vascular surgeons. The average
age of the patients was 52 ± 14 years, and 143 (83%) of the patients were
women. Our patients were referred to the clinic either by their family doctors
Ahmed Kayssi, MD, MSc, MPH
Marc Pope MD, MSc
Ivica Vucemilo, MD
Christiane Werneck, MD, MScCH
Accepted for publication
Oct. 15, 2014
Correspondence to:
C. Werneck
Division of Vascular Surgery
University of Toronto
89 Queensway West, Suite 500
Mississauga ON L5B 2V2
christiane.werneck@utoronto.ca
DOI: 10.1503/cjs.014914
Varicose veins are a common condition that can be treated surgically. Available
operative modalities include saphenous venous ligation and stripping, phlebec-
tomy, endovenous laser therapy and radiofrequency ablation. Radiofrequency
ablation is the newest of these technologies, and to our knowledge our group was
the rst to use it in Canada. Our experience suggests that it is a safe and effective
treatment for varicose veins, with high levels of patient satisfaction reported at
short-term follow-up. More studies are needed to assess long-term effectiveness
and compare the various available treatment options for varicose veins.
Summary
COMMENTAIRE
86 J can chir, Vol. 58, N
o
2, avril 2015
or another vein clinic, and they underwent preoperative
Doppler ultrasonography to identify reux within the tar-
get vein. The decision to offer a patient RFA was based on
the target vein anatomy and diameter. The maximum vein
diameter considered for the procedure was 1.8cm, and the
minimum was 0.4 cm. Elderly patients also underwent
arterial duplex scans to rule out arterial insufciency.
Most (72%) patients underwent treatment of a single
limb, and 89% of patients underwent treatment of a single
vein. The great saphenous vein was most frequently
treated (81%), followed by the small saphenous (7%) and
the accessory great saphenous (1%).
Postoperatively, the median time that patients took off
work was 2 days. While 80 (69%) patients needed no post-
operative analgesia, 35 (30%) patients used over the coun-
ter oral analgesics, such as acetaminophen or ibuprofen.
Only 1 patient needed an opioid analgesic. Duplex ultra-
sonography performed 2–4 weeks after the procedure
demonstrated successful vein occlusion in 99% of patients.
Only 1 patient showed evidence of partial recanalization
on follow-up. Two (1%) patients reported persistent pain
at 30-day follow-up, and 6 (4%) patients demonstrated
skin discoloration. Eight (5%) patients with residual large
veins returned to our clinic after the follow-up period and
underwent phlebectomy procedures.
Telephone interviews were conducted several weeks after
the procedure to assess patient satisfaction. Of the 111 (65%)
patients contacted, 83% were extremely satised, 12% were
very satised, 3% were somewhat satised, and 2% were not
too satised with their RFA experiences. However, all of
those who responded indicated that they would have this
procedure again and would recommend it to a friend.
Our experience suggests that RFA is a safe and effective
treatment for the management of varicose veins that is
associated with a high success rate and patient satisfaction.
Only 1 patient in our series demonstrated target-vein
recanalization on follow-up. This was a cirrhotic patient
with a history of hepatic failure who was on chronic anti-
coagulation therapy for multiple medical comorbidities.
Her vein was also 1.5 cm in diameter, which was close to
the cutoff of 1.8 cm that we accept in our practice.
To our knowledge, our group is the rst to describe the
successful implementation of RFA in Canada, where public
health insurance guidelines have greatly restricted the criter ia
for reimbursing venous procedures and where many vein
surgeries are performed at private clinics. In the face of this
changing reimbursement landscape, we believe that RFA is a
viable alternative to more conventional open vein surgeries
and EVLT, which are more widely available in Canada.
Our work as well as studies by other groups will hope-
fully continue to enrich the debate on the most suitable
intervention for the management of venous disease. A
2011 review by Ontario’s Medical Advisory Secretariat
found that RFA was superior to open vein surgery when
comparing postoperative pain, duration of recovery, major
adverse effects and patient preference, while open surgery
was less costly than RFA.
4
However, the same review
found no evidence to suggest major differences in postop-
erative pain between RFA and EVLT when pain was
adjusted for analgesic use, and any differences did not per-
sist after 1-month follow-up. Furthermore, the 2 proced-
ures did not differ when comparing treatment effectiveness
or durability. This was mostly because of a lack of studies
that have assessed long-term recurrence after either treat-
ment. Prospective, long-term studies are thus clearly
needed to compare the clinical and cost-effectiveness of
both treatments and provide health care consumers with
the best standard of care.
Afliations: All authors are from the Division of Vascular Surgery,
Trillium Health Partners, University of Toronto, Mississauga, Ont.
Competing interests: None declared.
Contributors: All authors contributed substantially to writing and/or
revising and to the conception and design of the manuscript and
approved the nal version for publication.
References
1. Gloviczki P, Comerota AJ, Dalsing MC, et al. The care of patients
with varicose veins and associated chronic venous diseases: clinical
practice guidelines of the Society for Vascular Surgery and the Amer-
ican Venous Forum. J Vasc Surg 2011;53:2S-48S.
2. Nesbitt C, Eifell RK, Coyne P, et al. Endovenous ablation (radiofre-
quency and laser) and foam sclerotherapy versus conventional sur-
gery for great saphenous vein varices. Cochrane Database Syst Rev
2011;CD005624. Medline
3. Bergan JJ, Kumins NH, Owens EL, et al. Surgical and endovascular
treatment of lower extremity venous insufciency. J Vasc Interv Radiol
2002;13:563-8.
4. Health Quality Ontario. Endovascular radiofrequency ablation for
varicose veins: an evidence-based analysis. Ont Health Technol Assess
Ser 2011;11:1-93.
... This catheter electrode will deliver a radiofrequency with high-frequency, which leads to venous spasm, collagen shrinkage, and physical contraction. 11 To determine the efficacy of RFA, there are three factors that can be assessed, venous occlusion, recanalization, and absence of recurrent reflux. RFA showed a good occlusion rate in less than three months, about 97%. ...
... However, most of the symptoms of this injury don't affect the patient's quality of life. 11,14 RFA also has a better cosmetic result because it only needs a small incision for insertion of the device. The patient who underwent the RFA method also has a higher early recovery rate and quickly returns to work. ...
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Introduction Chronic venous insufficiency (CVI) is a disease of the vein due to valve dysfunc-tion, venous obstruction, or both. This results in increased vein pressure and related to disruption in the vein system. 1 The incidence is relatively high. Globally, the incidence of CVI is about 63.9% and more common in women compared to men. 2 The sign and symptoms may vary from heaviness sensation, leg pain, telangiectasia (spider veins), reticular veins, varicose veins, edema, lipodermatosclerosis, and venous ulcer. 3 For an extended period, CVI may decrease the quality of life of the patient because of immobility and symptoms that patients experience. 4 The treatment strategy for CVI has been established, and there are several strategies depends on the severity of the disease. Conservational methods, such as pharmacological therapy and compressive stocking therapy could be given. However , it's not the definitive treatment. Another therapy option is by surgical therapy such as vein stripping but it requires hospitalization. 5 Development of CVI therapy has resulted in more advanced endovenous therapy with good efficacy and reduced complication. Ra-diofrequency ablation (RFA) is a promising minimal invasive therapy for CVI patients. 6 Radiofrequency Ablation And Venous Stripping The treatment for CVI is based on the severity of the disease, assessed by the CVI staging. The well-known classification for CVI is the Clinical-Etiological-Anatomical -Pathophysiological (CEAP) classification. For decades, treatment using surgical ligation and stripping of the great saphenous vein had been the gold standard for CVI. 7 However, this technique caused several complications ranging from neovascularization (exceeds 30%) and injury of the saphenous nerve. 8,9 To optimize the outcome and prevent serious complications, newer technique J Indon Med Assoc, Volum: 71, Nomor: 5, Oktober-November 2021 Is Radiofrequency Ablation Better than Venous Stripping for Management of CVI 207 J Indon Med Assoc, Volum: 71, Nomor: 5, Oktober-November 2021 has been developed. Radiofrequency abla-tion (RFA) is a minimal-invasive endove-nous heat-based procedure in treating CVI that shows promising result. The endovenous method has some benefits, such as fewer complications post procedure compared to venous stripping. 10 The procedure of RFA is done by using a catheter electrode guided by ultra-sound. This catheter electrode will deliver a radiofrequency with high-frequency, which leads to venous spasm, collagen shrinkage, and physical contraction. 11 To determine the efficacy of RFA, there are three factors that can be assessed, venous occlusion, recanali-zation, and absence of recurrent reflux. RFA showed a good occlusion rate in less than three months, about 97%. A study by Proebstle et al. showed a 100% occlusion rate after the initial procedure and a 95% occlusion rate after five years of follow up. 12,13 There was also a shorter hospitalization, reduced postoperative pain, and improvement in the quality of life after the patient underwent RFA procedure. 14 Compared to the gold standard, RFA is auspicious. The success rate from venous stripping-ligation and RFA are slightly different. 13-16 However, in a randomized clinical trial study by Mendes et al. there is a 20% difference in the primary success rate of the venous stripping-ligation method (100% primary success rate) and RFA method. (80% success rate). 10 The complication in the vein stripping-ligation is more apparent than in RFA. Neovascularization and nerve injury are the most common complications that can be found after vein surgery (up to 30% in vein stripping-ligation), and saphenous nerve injury is less found in RFA. However, most of the symptoms of this injury don't affect the patient's quality of life. 11,14 RFA also has a better cosmetic result because it only needs a small incision for insertion of the device. The patient who underwent the RFA method also has a higher early recovery rate and quickly returns to work. There was also a shorter hospitalization and reduced postoperative pain. A study in Canada showed that the patient could work as early as two days after the RFA procedure. It was also noted that 69% of the patients did not need any analgesia agents. 11 Subramonia et al. evaluated the pain that the patients experienced during the first week after the procedure. Patients who underwent RFA procedure had less pain in the first week compared to the vein-stripping method (1.7 vs 4). Although RFA has several benefits, it has a higher cost when compared to vein stripping-ligation. The cost of RFA could range 4-5 times more than the cost for stripping-ligation. 17
... The use of RF energy to produce tissue retraction has recently found a wide range of medical applications (17)(18)(19)24,25). In an animal model of wide-neck the leak to be targeted with RF, TEE and ICE provide real-time visualization of the tip of the ablation catheter ( Figure 1C) and of its depth within the leak. ...
... Among patients with patent foramen ovale, 90% did not show any residual interatrial communication after RF energy delivery along the upper septum primum(19). Similarly, RF energy was successfully tested for endovenous treatment of varicose veins(17,25), to promote wound healing(26), to treat sleep apnea via stiffening and reduction of the soft palate(27), and many more. The proposed mechanism for the described tissue effects of RF energy is based on the promotion of fibroblast proliferation and collagen synthesis, which may lead to tissue shrinkage and physical contraction. ...
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Objectives The aim of this study was to evaluate the efficacy of radiofrequency (RF) energy applications targeting the atrial side of a significant residual leak in patients with acute and chronic evidence of incomplete percutaneous left atrial appendage (LAA) occlusion. Background RF applications have been proved to prevent recanalization of intracranial aneurysms after coil embolization, thereby favoring complete sealing. From a mechanistic standpoint, in vitro and in vivo experiments have demonstrated that RF promotes collagen deposition and tissue retraction. Methods Forty-three patients (mean age 75 ± 7 years mean CHA2DS2-VASc score 4.6 ± 1.4, mean HAS-BLED score 4.0 ± 1.1) with residual leaks ≥4 mm after Watchman implantation were enrolled. Procedural success was defined as complete LAA occlusion or presence of a mild or minimal (1- to 2-mm) peridevice leak on follow-up transesophageal echocardiography (TEE), which was performed approximately 45 days after the procedure. Results RF-based leak closure was performed acutely after Watchman implantation in 19 patients (44.2%) or scheduled after evidence of significant leaks on follow-up TEE in 24 others (55.8%). The median leak size was 5 mm (range: 4-7 mm). On average, 18 ± 7 RF applications per patient (mean maximum contact force 16 ± 3 g, mean power 44 ± 2 W, mean RF time 5.1 ± 2.5 minutes) were performed targeting the atrial edge of the leak. Post-RF median leak size was 0 mm (range: 0-1 mm). A very low rate (2.3% [n = 1]) of major periprocedural complications was observed. Follow-up TEE revealed complete LAA sealing in 23 patients (53.5%) and negligible residual leaks in 15 (34.9%). Conclusions RF applications targeting the atrial edge of a significant peri-Watchman leak may promote LAA sealing via tissue remodeling, without increasing complications. (RF Applications for Residual LAA Leaks [REACT]; NCT04726943)
... It has a life-long prevalency approximately 30% in general population. 10 It leads to discomfort in the lower extremities, cramps, pain and in advanced cases, edema, pigmentation and ulcer formation all of which signifi cantly affect the quality of life of the patients. 11 The sapheno-femoral junction insuffi ciency and/or refl ux disease of the VSM are blamed for superfi cial venous refl ux phenomenon in most instances. ...
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Background: It has been recently postulated that infl ammation may have an effect on varicose vein development and prognosis, besides increased venous pressure. CRP/albumin (CAR) is a novel infl ammatory marker associated with poor prognosis in a various group of patients. Our aim in this study was to investigate the relation between varicose greater saphenous vein (VSM) diameter and CAR. Methods: A total of 150 patients with patients VSM insuffi ciency (Group 1, n: 114) and normal VSM (n: 36) were included in the study. The diameter of the VSM was measured with B-mode ultrasound, and refl ux was quantifi ed based on valve closure time using Doppler spectral tracings. Blood samples were taken during recruitment. The CAR value is determined by dividing the serum CRP level to the albumin level. Results: There were 21 (18.4%) males and 93 (81.5%) females in Group 1 and 7 males and 29 females in Group 2. Mean age of the patients were similar in both groups (48.02-12.20 years in Group 1 vs. 44.9-8.92 years in Group 2, p = 0.44). Mean BMI of the patients did not differ signifi cantly (Group 1: 26.4-3.7 kg/m2 correvs. Group 2: 25.7-4.2 kg/m2, p = 0.13). The mean diameter of VSM was measured 5.70-0.29 mm in Group 1 whereas 3.21-0.34 mm in Group 2 (p = 0.0023). Mean CRP and albumin values in Group 1 were 6.18-4.99 mg/L and 4.45-0.27 g/dL whereas 4.25-2.46 mg/L and 6.18-1.14 g/dL in Group 2, respectively (p value for CRP = 0.049, p value for albumin = 0.074). CRP/albumin was 1.28-1.34 in Group 1 and 1.11-1.21 in Group 2, which was not statistically signifi cant (p = 0.58). There was a positive moderately strong correlation between VSM diameter and CRP/albumin ratio as well as superfi cial venous refl ux disease (r: 0.48). Conclusion: CRP/albumin ratio is associated with increased incidence of varicose veins and increased diameter of greater saphenous vein; hence, superfi cial venous refl ux disease. The fi ndings support the hypothesis that systemic infl ammation may play a role in varicose vein disease.
... Endovenous ablation using RFA performed as an outpatient are likely to be cost-effective treatment strategies for patients with primary unilateral GSV reflux requiring treatment [3]. Compared with conventional open surgery, RFA can be performed in the outpatient setting without the requirement for hospital admission or general anesthesia [4]. Radiofrequency ablation and foam are associated with a faster recovery and less postoperative pain than endovenous laser ablation and stripping [5]. ...
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... The RFA scheme diagram is shown in Figure 2. The tissue temperature should be kept in the optimal range to ensure efficiently ablate the VV, to prevent carbonization around the edge of the electrode because of the heating unnecessarily [12], and to induce tissue death in the ideal value of 50°C-100°C. One of the key principles of RFA is Year 4 (2020) Vol: 16 Issued in DECEMBER, 2020 www.ejons.co.uk therefore to obtain and sustain a temperature value of 50°− 100° for at least 4 -6 minutes over the entire target volume [13]. Additionally, the slow thermal conduction from the electrode to the surface through the tissue can be increased the application duration to 10-30 minutes. ...
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... Our finding in this regard is comparable to a study conducted in Bulgaria (64%) 10. However, a study in Canada found a remarkably higher prevalence of varicose vein among women (83%) 6 . Women are prone to varicose vein because of their physiological conditions like pregnancy, menopause, hormonal fluctuation and alteration of the viscosity of blood because of oral contraceptive pills 5,7 . ...
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Introduction: The varicose vein is a common chronic vascular disease affecting people with predisposing factors like restricted mobility, pregnancy, obesity, and long-standing jobs. According to CEAP (Clinical, Etiological, Anatomical, and Pathological) classification, there are six categories of CEAP ranging from C0 or no sign to C6 or active ulceration of the vein. Radiofrequency Ablation (RFA) is the minimally invasive procedure to manage varicose vein. This study aims to assess cutaneous manifestation and quality of life among participants who underwent RFA in the Dhulikhel Hospital. Methodology: This study is retrospective review of the clinical and surgical report of 171 consecutive number of patients admitted with varicose veins and treated with Radio Frequency Ablation from January 2015 to December 2016. The cutaneous manifestation of all the patients were noted prior to surgery and were followed up in two months to note the manifestation again. Results: The total number of patients were171 with 79 male (46.2%) and 92 female (53.8%). The mean age was 48.9 years (S.D. 6.8). In pre-ablative stage, there were 42.1% patients in C4 stage, 30.4% patients in C3 stage, 16.4% in C2 stage. In post-ablative stage, there were 39.8% patients in C4 stage, 16.4% in C1 and 11.7% in C2 stage. In 53.8% of patients, there was a decrease in C stage postoperatively. Findings of this study are encouraging in terms of C staging after RFA, and it paves the way for further exploration of RFA.
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Introduction: In the current study, we present single surgeon experience of a new radiofrequency ablation system, the catheter, and the device. Patients and Methods: The new system, which comprises a generator and an intervally illuminated radiofrequency ablation catheter, was used for the treatment of 272 consecutive patients with chronic venous insufficiency of the great saphenous vein between November 2017 and October 2018. Mean age of the patients was 53.40 ± 11.91 years. Mean saphenous vein diameter was 8.51 ± 2.45 mm. Bilateral great saphenous vein reflux disease was present in 19% (51 cases) of the patients. At the end of the procedure, the closure of the great saphenous vein was confirmed with Doppler ultrasonography. Results: Procedures could be successfully performed in all, except 1 obese (BMI> 30 kg/m ² ) male patient. At the 3rd month, outpatient clinic follow-up control Doppler USG revealed successful ablation of the treated great saphenous vein in 260 patients (96%), whereas in 12 cases (4%), there was continuing reflux. The diameters of the saphenous veins in these patients ranged between 6.9 mm and 19.5 (mean: 10.68 ± 3.41) mm. Ten patients could be treated successfully with ablation with the same device controlled both at the interventional section as well as on the 3rd month outpatient clinic follow-up. The remaining patients underwent high ligation of the great saphenous vein. Paresthesia occurred in 1 patient and had been permanent. Hematoma occurred in a male patient and resolved spontaneously. Conclusion: Preliminary results of our new radiofrequency ablation device with illumination guidance for the treatment of great saphenous vein reflux disease indicated successful results with enhanced physician utilization, comfort, and reliability.
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Endovenous ablation has become the preferred means to treat superficial venous insufficiency. Ablative technologies have evolved to include a variety of both thermal and nonthermal techniques. The reported thrombotic complications of endovenous heat induced thrombosis (EHIT) and deep venous thrombosis (DVT) associated with thermal techniques are low (<2% overall). However, the limited data on newer non-thermal technologies suggest these modalities may have thrombotic complication rates upwards of 6%. Additionally, the pathophysiology of thrombotic events related to mechanochemical ablative techniques may differ from EHIT, and thus, may have different implications for management. Described is a case report of a stroke after cyanoacrylate ablation of the great saphenous vein, and a review of the current literature reporting the thrombotic complications associated with current thermal and non-thermal techniques. There exists a need for high volume studies on newer ablative techniques to fully understand their associated thrombotic complications. This review highlights the need for a comprehensive classification system and standard treatment algorithm encompassing of thrombotic complications associated with both thermal and non-thermal ablative techniques.
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Background and objective: Minimally invasive procedures such as foam sclerotherapy and radiofrequency ablation (RFA) have gained attention for treatment of incompetent great saphenous vein (GSV). The objective of this study was to compare recurrence rate and quality of life between foam sclerotherapy and RFA in patients with incompetent GSV varicose veins. Methods: In this parallel single-blinded randomized clinical trial, 60 adult patients with primary varicose veins due to incompetent GSV (CEAP classes C2-4EPAsPr) were included and randomly divided to receive RFA or foam sclerotherapy. Health-related quality of life (HRQOL) was assessed by the Short Form 36, and the Aberdeen Varicose Vein Questionnaire (AVVQ) was applied to assess the impact of varicose veins on quality of life of the patients. In addition, pain severity after the procedures was investigated by a visual analog scale (VAS) (range, 0 to 10). The patients were followed at 1 week, 1 month, 3 months, and 6 months postoperation. GSV reflux and recurrence was assessed by color Doppler ultrasound examination after 6 months. Results: Twenty-eight patients in RFA and 27 patients in foam sclerotherapy remained for the final analyses. The time interval from the procedure and recovery to daily normal activities was 1 day in both groups. Mean (±SD) pain VAS score in RFA group decreased from preintervention score of 7.35 (±3.28) to 1.21 (±0.68); P < .0001. Likewise, this score decreased from 6.64 (±2.04) to 1.29 (±0.91) in foam sclerotherapy group. HRQOL scores increased gradually at 1, 3, and 6 months after the intervention. AVVQ scores decreased significantly 1 week postintervention in both groups. After 6 months, 17.9% (5 patients) in RFA group and 14.8% (4 patients) in foam sclerotherapy group had recurrence of GSV reflux (P = .52). Conclusion: Both foam sclerotherapy and RFA were effective in treatment of GSV reflux. Comparable findings were observed between the 2 groups regarding postoperative pain, recovery time, HRQOL, and AVVQ scores.
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Minimally invasive techniques to treat great saphenous varicose veins include ultrasound-guided foam sclerotherapy (USGFS), radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). Compared with conventional surgery (high ligation and stripping (HL/S)), proposed benefits include fewer complications, quicker return to work, improved quality of life (QoL) scores, reduced need for general anaesthesia and equivalent recurrence rates. To review available randomised controlled clinical trials (RCT) data comparing USGFS, RFA, EVLT to HL/S for the treatment of great saphenous varicose veins. The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialised Register (July 2010) and CENTRAL (The Cochrane Library 2010, Issue 3). In addition the authors performed a search of EMBASE (July 2010). Manufacturers of EVLT, RFA and sclerosant equipment were contacted for trial data. All RCTs of EVLT, RFA, USGFS and HL/S were considered for inclusion. Primary outcomes were recurrent varicosities, recanalisation, neovascularisation, technical procedure failure or need for re-intervention, patient quality of life (QoL) scores and associated complications. Secondary outcomes were type of anaesthetic, procedure duration, hospital stay and cost. CN, RE, VB, PC, HB and GS independently reviewed, assessed and selected trials which met the inclusion criteria. CN and RE extracted data. The Cochrane Collaboration's tool for assessing risk of bias was used. CN contacted trial authors to clarify details. Thirteen reports from five studies with a combined total of 450 patients were included. Rates of recanalisation were higher following EVLT compared with HL/S, both early (within four months) (5/149 versus 0/100; odds ratio (OR) 3.83, 95% confidence interval (CI) 0.45 to 32.64) and late recanalisation (after four months) (9/118 versus 1/80; OR 2.97 95% CI 0.52 to 16.98), although these results were not statistically significant. Technical failure rates favoured EVLT over HL/S (1/149 versus 6/100; OR 0.12, 95% CI 0.02 to 0.75). Recurrence following RFA showed no difference when compared with surgery. Recanalisation within four months was observed more frequently following RFA compared with HL/S although not statistically significant (4/105 versus 0/88; OR 7.86, 95% CI 0.41 to 151.28); after four months no difference was observed. Neovascularisation was observed more frequently following HL/S compared with RFA, but again this was not statistically significant (3/42 versus 8/51; OR 0.39, 95% CI 0.09 to 1.63). Technical failure was observed less frequently following RFA compared with HL/S although this was not statistically significant (2/106 versus 7/96; OR 0.48, 95% CI 0.01 to 34.25). No randomised clinical trials comparing HL/S versus USGFS met our study inclusion criteria. QoL scores and operative complications were not amenable to meta-analysis. Currently available clinical trial evidence suggests RFA and EVLT are at least as effective as surgery in the treatment of great saphenous varicose veins. There are insufficient data to comment on USGFS. Further randomised trials are needed. We should aim to report and analyse results in a congruent manner to facilitate future meta-analysis.
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The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) have developed clinical practice guidelines for the care of patients with varicose veins of the lower limbs and pelvis. The document also includes recommendations on the management of superficial and perforating vein incompetence in patients with associated, more advanced chronic venous diseases (CVDs), including edema, skin changes, or venous ulcers. Recommendations of the Venous Guideline Committee are based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system as strong (GRADE 1) if the benefits clearly outweigh the risks, burden, and costs. The suggestions are weak (GRADE 2) if the benefits are closely balanced with risks and burden. The level of available evidence to support the evaluation or treatment can be of high (A), medium (B), or low or very low (C) quality. The key recommendations of these guidelines are: We recommend that in patients with varicose veins or more severe CVD, a complete history and detailed physical examination are complemented by duplex ultrasound scanning of the deep and superficial veins (GRADE 1A). We recommend that the CEAP classification is used for patients with CVD (GRADE 1A) and that the revised Venous Clinical Severity Score is used to assess treatment outcome (GRADE 1B). We suggest compression therapy for patients with symptomatic varicose veins (GRADE 2C) but recommend against compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation (GRADE 1B). We recommend compression therapy as the primary treatment to aid healing of venous ulceration (GRADE 1B). To decrease the recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy (GRADE 1A). For treatment of the incompetent great saphenous vein (GSV), we recommend endovenous thermal ablation (radiofrequency or laser) rather than high ligation and inversion stripping of the saphenous vein to the level of the knee (GRADE 1B). We recommend phlebectomy or sclerotherapy to treat varicose tributaries (GRADE 1B) and suggest foam sclerotherapy as an option for the treatment of the incompetent saphenous vein (GRADE 2C). We recommend against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C(2); GRADE 1B), but we suggest treatment of pathologic perforating veins (outward flow duration ≥500 ms, vein diameter ≥3.5 mm) located underneath healed or active ulcers (CEAP class C(5)-C(6); GRADE 2B). We suggest treatment of pelvic congestion syndrome and pelvic varices with coil embolization, plugs, or transcatheter sclerotherapy, used alone or together (GRADE 2B).
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Lower extremity venous insufficiency is a highly prevalent condition. Now it is understood that telangiectasias, reticular varicosities, and true varicose veins are physiologically similar and etiologically identical. The four main influences causing these abnormalities are heredity, female sex, gravitational hydrostatic forces, and hemodynamic muscular compartment pressure. There are clear indications and goals for intervention. A cornerstone in the treatment of venous insufficiency is elimination of sources of venous hypertension. One of these is the refluxing greater saphenous vein. Minimally invasive saphenous ablation can be achieved by radiofrequency energy and laser light energy. These new techniques eliminate the psychologic barrier to treatment caused by the term "stripping" and allow the objectives of surgery to be achieved with minimal invasion and quick recovery. Endovenous techniques show great promise. They provide minimal invasion, often under local anesthesia and intravenous sedation, thereby eliminating the need for general anesthesia. Objectives of venous insufficiency have been established and the endoluminal minimally invasive techniques developed in recent years appear to accomplish their goals.
Endovascular radiofrequency ablation for varicose veins: an evidence-based analysis
  • Health Quality Ontario
Health Quality Ontario. Endovascular radiofrequency ablation for varicose veins: an evidence-based analysis. Ont Health Technol Assess Ser 2011;11:1-93.