An update on operative treatments of primary superficial vein incompetence: part 2.
of primary superficial vein
incompetence: part I.
Unité de Pathologie Vasculaire
In part 2 of “An update on operative treatment of primary superficial vein incompetence,” all randomized controlled trials (RCTs) published since 1990 on operative treatments of varicose veins were collected and the references were gathered in tables according to either the procedure used or the patient’s clinical status. Case series and meta-analyses were taken into account in this review when RCTs were not available. For more details regarding clinical or instrumental outcomes of the studies described, please go to www.phlebolymphology.org. In the second part of this article, the indications for operative treatment of varicose veins will be discussed. These indications are not specific, as many factors must be taken into account and, unfortunately, in practice it is not always based on evidence. Finally, the recently published international recommendations about the use of the various procedures for varicose vein ablation will be reviewed.
Outcomes after operative treatment
Randomized controlled trials (RCTs) are very good tools for comparing the results of the various operative treatments for varicose veins. Yet, before drawing definitive conclusions on any of these procedures, an accurate publication analysis is mandatory as RCTs often contain hard-to-identify bias. For example, the short-term results of a procedure greatly depend on the type of anesthesia performed during varicose vein ablation (local tumescent anesthesia or general anesthesia).1 In the absence of RCTs for evaluating a procedure, case series are considered even though they provide a weaker level of evidence. Well-designed meta-analyses can provide valuable information for clinicians. By combining RCTs, meta-analyses increase the sample size, and thus, the power to study the results of a given procedure. Study outcomes are usually divided into the following 3 categories: (i) postoperative outcomes (3 years for RCTs and >5 years for case series. Nevertheless, this review’s outcome analysis has been divided into two parts: (i) postoperative and mid-term outcomes and (ii) long-term outcomes.
Classic open surgery has been compared with conservative treatment both in C2 and C5-C6 patients (Tables I.1 and I.2).2-13 In addition, classic open surgery has been compared with open surgery variants (Tables I.3 and I.4), such as cryostripping14,15 and tributary-powered phlebectomy16-20– techniques that are only rarely used in current practice. Some RCTs (Table I.5)22-35 provide interesting information on how classical stripping influences nerve damage,22,25,29 the short- and long-term outcomes according to the procedure used,24,30,33 the results following saphenofemoral junction ablation and ligation21,26,35 or associated perforator ablation.30 The RCTs comparing classic open surgery with other ablative procedures are more interesting and are shown in Table I.6 to I.15.36-86 Additionally, the CHIVA method (Cure Hémodynamique de l’Insuffisance Veineuse en Ambulatoire [conservative ambulatory hemodynamic management of varicose veins]) is performed under local anesthesia when other open surgery techniques need spinal or general anesthesia, and as a result, CHIVA shortens the length of the hospital stay (Table I.6).36,37
All RCTs that compared the short-term results of classic open surgery with radiofrequency ablation (RFA), endovenous laser ablation (EVLA), endovenous steam ablation,81 endovenous microwave ablation, ultrasound-guided foam sclerotherapy (UGFS), and high ligation with tributary phlebectomy concluded that both endovenous procedures and high ligation with tributary phlebectomy are less painful than classic open surgery and these procedures shorten the time required before returning to normal activity. Sensory impairment and ecchymosis are less severe with endovenous microwave ablation than open surgery, even though endovenous microwave ablation causes skin burns, 10% of which are related to slow probe withdrawal or using energy that is too high (Table I.14).82 However, when modern open surgery is performed under local anesthesia (unfortunately by very few teams), it is as effective postoperatively as any endovenous procedure.
Endovenous procedures have been widely studied and compared with open surgery and other endovenous procedures.
Radiofrequency ablation. RFA has been compared with open surgery, cryostripping, invagination stripping, EVLA, and UGFS (Table I.7, I.12, I.16, and I.17).38-46,79,80,87-91 Studies of EVLA using bare fibers vs RFA favored the latter since it is less painful and results in less ecchymosis. However, it is now acknowledged that radial fibers, which are currently used, provide better postoperative results than bare fibers.92 No differences in efficacy and undesirable effects were observed between RFA and UGFS in a 4-arm study.79,80 At a 1-year follow-up, redo operations were less frequent after RFA compared with deleted or synchronized ambulatory incompetent tributary avulsion (Table I.18).93
Endovenous laser ablation. Treating varicose veins with EVLA is a safe procedure in patients with active ulcers. Ulcers healed faster after EVLA than in patients undergoing compression therapy alone and no ulcer recurrence occurred during a 1-year period posttreament.13 EVLA has been compared with open surgery, cryostripping, invagination stripping, EVLA has been compared with open surgery (Table I.8)47-63, with open surgery and UGFS (Table I.11)76-78, in a 4-arm RCT including open surgery, EVLA, RFA, UGFS (Table I.12)79-80, with invagination stripping (Table I.16)87-91, with steam ablation (Table I.19)100, and with cryostripping (Table I.29).94-96 All procedures were similarly effective in patients with varicose veins94,95 and EVLA had a similar, but slightly higher cost.96
When comparing UGFS and EVLA (Table I.11 and I.25),76-78,97-99 no differences at 3 months97,98 were observed for clinical results or vein obliteration, but UGFS outperformed EVLA in cost, treatment duration, postoperative pain reduction, and recovery. At 15 months,99 there were no differences in clinical results, but vein occlusion was higher with EVLA. At a 1-year follow-up, Biemans et al found no difference between the EVLA and UGFS in complications and clinical results, but UGFS resulted in lower occlusion rates.76 Brittenden et al showed similar clinical efficacy between UGFS and EVLA, but EVLA had fewer complications and UGFS had lower ablation rates at both 6 weeks and 6 months posttreatment.77 Tassie et al showed that EVLA has the highest probability of being cost-effective compared with classic open surgery and UGFS.78
The 1-year treatment success of high-dose EVLA was not inferior to that of endovenous steam ablation. Several secondary outcomes (eg, painful legs, patients’ satisfaction, duration of analgesia, and limitations in daily life) were in favor of endovenous steam ablation (P<0.001).100
Data from ten RCTs on EVLA variants (Table I.20)92,101-111 show that: (i) below-knee EVLA was not associated with saphenous nerve injury104; (ii) lower postoperative pain and better Venous Clinical Severity Scores (VCSS) were obtained with radial fibers compared with bare fibers92 or tulip fibers109; (iii) cold tumescent anesthesia had fewer side effects and a reduction in analgesic intake than warm tumescent anesthesia106,107; and (iv) symptom intensity was lower and quality of life better when compression was applied for 2 to 7 days posttreatment.110
Sclerotherapy. Postoperative, short-term, and mid-term results are difficult to compare because many different protocols and outcome criteria were used (Tables I.10 to I.12).65-80 RCTs on variants of sclerotherapy provide some data on postoperative course and short- or mid-term outcomes. Foam sclerotherapy provides better results than liquid sclerotherapy (Table I.22),113-117 and occlusion rates are similar when using either a 1% or 3% polidocanol foam solution (Table I.24).124-126 The use of postoperative compression does not influence the percentage of patients with side effects after UGFS (Table I.25).97-99
Glue. No RCTs evaluating glue vs other procedures have been conducted, but a case series has reported good results at a 2-year follow-up–occlusion rates were 92% and a significant improvement in VCSS was observed.127
There are no RCTs for Clarivein_, but case series are available.128-130 At a 6-month follow-up, the occlusion rate was 96% and the VCSS improved in a series of patients presenting with saphenous vein varices.128 In the case series by Boersma et al on patients who underwent short saphenous vein ablation, the occlusion rate at 1 year was 94% and the VCSS improved.130
The term PREsence of Varices After operatIve Treatment (PREVAIT) was adopted in the VEIN-TERM transatlantic interdisciplinary consensus document.131 PREVAIT is a frustrating problem for both the patients with varicose veins and the physicians who treat these varicose veins. Recurrent Varices After Surgery (REVAS) have been previously compared with classic open surgery.132
The Venous Clinical Score (VCSS), Venous Segmental Disease Score (VSDS), and Aberdeen Varicose Vein Severity Score (AVVSS)–are used in the literature to assess treatment success rates. VCSS is a very good tool for evaluating the treatment of complicated varices, but it is less informative for uncomplicated C2 patients.133,134
Generic and specific health-related quality of life questionnaires
Many health-related quality of life questionnaires have been used, including AVVQ, the Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ), the Specific Quality of Life and Outcome Response-Venous (SQOR-V), and the results have been compared with anatomic, hemodynamic, and clinical outcomes before and after operative treatment.135 Patient-Reported Outcome Measures (PROMs) are new and very promising tools.136
Instrumental investigation measurements
These measurements rely on occlusion rates and hemodynamic function. It has been clearly identified that the correlation between clinical and investigational parameters is far from perfect.
Information provided by RCTs
Open surgery vs high ligation and tributary phlebectomy
These procedures were assessed in 2 RCTs with 4, 5, and 11 years of follow-up24,83-86 and there were no differences in clinical outcomes. More redo surgery was performed in the group with high ligation and tributary phlebectomy, but preoperative and postoperative investigations were outdated in both groups.
Open surgery vs CHIVA
CHIVA was compared with classic open surgery in 2 RCTs with 5 and 10 years of follow-up (Table I.6).36,37 Both RCTs favor CHIVA in terms of PREVAIT reduction, but bias was identified to weaken the authors’ conclusions.
Open surgery vs radiofrequency ablation
Only one RCT comparing long-term outcomes (3-year) of open surgery with RFA is available and there was no difference in clinical results between the two groups,150 but the Closure® catheter used was older and less efficient that the Closure FAST® catheter.
Open surgery vs EVLA
At a 5-year follow-up, a RCT comparing EVLA with open surgery found no difference between the 2 groups in persistent reflux, PREVAIT, redo treatment, VCSS, and generic and specific health-related quality of life scores. In this trial, open surgery was minimally invasive and the EVLA procedure used a bare fiber with a 980-nm diode laser and a stepwise laser withdrawal.60
Sclerotherapy vs various open surgery procedures
Belcaro et al reported two series with long-term follow-up data, but no conclusive results were obtained.67,68 The RCT comparing UGFS complemented by high ligation with open surgery at a 3- to 5-year follow-up was more informative, showing that the treatment was equally effective in both groups, which was demonstrated by improvements in the VCSS, VSDS, and the generic health-related quality of life scores. At 5 years posttreatment, the AVVQ was significantly better in the open surgery group.72
Information provided by case series
The most documented outcomes are provided by classic open surgery, but most studies are retrospective. In a 34-year follow-up study, varicose veins were present in 77% of the lower limbs examined and most were symptomatic–58% were painful, 83% had a tired feeling, and 93% showed a reappearance of edema.137 Two prospective studies concerning classic open surgery are available with a 5-year follow-up.138,139 In both studies, patients were preoperatively investigated with duplex scanning and treated by high ligation, saphenous trunk stripping, and stab avulsion. In the Kostas et al series, 28 out of 100 patients had PREVAIT after 5 years, where the recurrent varices mainly resulted from neovascularization (8/28, 29%), new varicose veins as a consequence of disease progression (7/28, 25%), residual veins due to tactical errors (eg, failure to strip the great saphenous vein) (3/28, 11%), and complex patterns (10/28, 36%).139
In the van Rij series, 127 limbs (CEAP class C2-C6) were evaluated postoperatively by clinical examination, duplex scanning, and air plethysmography. At the clinical evaluation, recurrence of varicose veins was progressive from 3 months (13.7%) to 5 years (51.7%). In line with clinical changes, a progressive deterioration in venous function was measured by air plethysmography and reflux recurrence was assessed by duplex scanning.138 These two studies showed that recurrence of varicose veins after surgery is common, even in highly skilled centers. Even if the clinical condition of most affected limbs after surgery improved compared with before surgery, progression of the disease and neovascularization are responsible for more than half of the recurrences. Rigorous evaluation of patients and assiduous surgical techniques might reduce the recurrence resulting from technical and tactical failures.
A 5-year follow-up of a large series of patients treated with RFA using a Closure plus catheter showed that vein occlusion and absence of reflux were present in 87.2% and 83.8% of patients, respectively. Symptoms, including pain, fatigue, and edema, significantly improved compared with the preoperative status. The rate of PREVAIT progressed from 6 months (7.7%) to 5 years (27.4%).140 Currently, no longterm results are available for Glue and Clarivein®
Information provided by meta-analyses
Since 2009, six meta-analyses on operative treatment of primary varicose veins by open surgery, RFA, EVLA, and UGFS were identified–all produced similar conclusions.141-146
Final remarks concerning outcomes after operative treatment
The immediate postoperative course, including side effects, recovery time, and convalescence, is better in all other procedures compared with classic open surgery, but this point is questioned if modern and minimally aggressive open surgery is used. No differences in recurrence between classic open surgery compared with RFA and EVLA are present at the mid- or long-term follow-up. PREVAIT is more frequent after UGFS compared with other mentioned procedures, but PREVAIT can be easily and effectively treated with redo UGFS.
Operative treatment indications
In patients with primary superficial reflux who are classified as C2, indications for operative treatment rely on patient complaints, such as symptoms and cosmetics, and on the extent and size of the varices. For patients in the C3 to C6 classes, operative treatment must be considered in all cases, except for the usual contraindications. However, in all clinical classes, nonvenous causes must be identified because venous symptoms are not pathognomonic and some signs, including edema and ulcers may be due to other etiologies. In the presence of axial deep primary reflux combined with primary varices, varicose veins must be treated first. However, we know that, in about half of the patients, axial deep primary reflux is not corrected by varicose vein ablation147 and its persistence is responsible for varices recurrence.148,149
When incompetent perforators are associated with primary varices, do they need to be treated in the same session? As no RCTs have compared the outcomes after varicose vein ablation with perforator ablation + varices ablation, no evidence-based information is available. Nevertheless, we know that, in half of these patients, incompetent perforators are no longer identified after varices ablation.* To summarize, perforator ablation can be reserved for patients with persistent incompetent perforator vessels, abnormal hemodynamic parameters, or continued symptoms and/or signs (C4b-C6) after superficial ablative surgery.152 Nevertheless, one RCT favors treating perforators in C6 patients to prevent ulcer recurrence (Table I.28).153
PREVAIT represents a particular situation in terms of indication.154 Managing patients with PREVAIT varies according to the clinical situation. Patients attending a routine follow-up, who are either asymptomatic or symptomatic, and not complaining of recurrences are managed differently than symptomatic patients who are complaining of cosmetic problems and presenting with complicated varices (C3-C6).150 A consensus document agrees that UGFS is the first-line treatment in almost all cases, except in patients presenting with varicose veins of the lower limbs that are fed by pelvic refluxive veins. The European guidelines for sclerotherapy assigned a Grade 1B to this procedure.156 In the absence of RCTs, this recommendation is based on case series.157,158
* Except in presence of associated axial deep reflux.150-152
In practice, the choice of the procedure is frequently not made on evidence-based data, but on other factors, such as: (i) personal mastery of the different techniques– practitioners will favor the procedures they have mastered; (ii) coverage/reimbursement by the health services/ health insurance, which varies from country to country; (iii) the patient’s choice, which is influenced by possible postoperative problems, recovery time, time off work, the procedure that provides the easiest control of recurrences, and information from friends, literature, or the internet.
Recommendations from five guidelines are summarized in Table II. The guidelines of the Society for Vascular Surgery/ American Venous Forum (SVS/AVF) were published in 2011.159 Most recommendations remain valid, but are not fully applicable in Europe. The SVS/AVF guidelines were analyzed by a European team.160 In 2013, the European Guide for Sclerotherapy was made available, giving much information on sclerotherapy, including practical information.156 In 2014, the European Venous Forum (EVF) and the International Union of Angiology (IUA) published a guidelines document on the management of chronic venous disorders.161 The International guidelines on endovenous thermal ablation were published in 2015. This consensus document also provides many technical details.162 The same year, the European Society for Vascular Surgery (ESVS) endorsed guidelines on the management of chronic venous disease.163
Most of these guidelines used the Guyatt grading scheme, which classifies recommendations as strong (grade 1) or weak (grade 2), according to the balance among benefits, risks, burdens, cost, and the degree of confidence in the estimates of benefits, risks, and burdens. It classifies quality of evidence as high (grade A), moderate (grade B), or low (grade C) according to factors, such as study design, consistency of the results, and directness of the evidence.164 Only the ESVS guidelines used the European Society of Cardiology’s grading system. For each recommendation, the letter A, B, or C marks the level of current evidence. Weighing the level of evidence and expert opinion, every recommendation is subsequently marked as either class I, IIa, IIb, or III. The lower the class number, the more proven the efficacy and safety of a certain procedure.165
In 2013, the National Institute for Health and Care Excellence (NICE) published a document on varicose veins of the leg,166 where the recommendations for people with confirmed varicose veins and truncal reflux were as follows:
• First, offer endothermal ablation (RFA for varicose veins [NICE interventional procedure guidance 8]167 and EVLA for the long saphenous vein [NICE interventional procedure guidance 52]168).
• If endothermal ablation is unsuitable, offer UGFS (see UGFS for varicose veins [NICE interventional procedure guidance 440]169).
• If UGFS is unsuitable, offer surgery.
• If incompetent varicose tributaries are to be treated, consider treating them at the same time.166
Operative treatment of primary varicose veins is currently performed using minimally invasive procedures, excluding spinal or general anesthesia. The problem is that the development of new procedures or devices is so rapid that when long-term outcomes are available, particularly for RCTs, the technique or material evaluated is frequently no longer used. Postoperative quality of life has improved, complications are far less frequent, and sick leave is shorter. The long-term frequency of PREVAIT is approximately the same for all techniques used, as long as the initial procedure has been correctly executed. To minimize the severity of PREVAIT, it is crucial to have regular patient follow-up and use ultrasound investigation to manage possible varices recurrence.
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