Abstract
In 2013, the new Dutch guideline for “Venous Pathology” was published. The guideline was a revision and update from the guideline “Diagnostics and Treatment of Varicose Veins” from 2009 and the guideline “Venous Ulcer” from 2005. A guideline for “Deep Venous Pathology” and one for “Compression Therapy” was added to the overall guideline “Venous Pathology.” The chapter about treatment of recurrent varicose veins after initial intervention was recently updated in 2015 and is reviewed here. The Dutch term “recidief varices” or the French “récidive de varices” should be used analogous to the English term “recurrent varicose veins.” The DCOP Guideline Development Group Neovarices concluded that “recidief” in Dutch actually suggests recurrence after apparent successful treatment and ignores the natural progression of venous disease in its own right. So the group opted to use the term “neovarices.” In the Dutch guideline, neovarices is meant to be an all embracing term for recurrent varicose veins caused by technical or tactical failure, evolvement from residual refluxing veins or natural progression of varicose vein disease at different locations of the treated leg after intervention. This report reviews the most important issues in the treatment of varicose vein recurrence, and discusses conclusions and recommendations of the Dutch Neovarices Guideline Committee.
Keywords
Introduction
In 2013, the latest Dutch guideline for “Venous Pathology” was published. 1 The guideline was a revision and update of the guideline “Diagnostics and Treatment of Varicose Veins” from 2009 and the guideline “Venous Ulcer” from 2005. Guidelines for “Deep Venous Pathology” and for “Compression Therapy” were added to the overall guideline “Venous Pathology.” The treatment of recurrent varicose veins (RVVs) after primary intervention was initially not included in the 2013 guideline “Venous Pathology” due to time constraints and lack of resources.
It was felt that the prevention and treatment of RVVs required separate attention. The estimated rates of recurrent venous disease remain high. Patient satisfaction is poorer than after primary intervention. RVVs are technically more demanding and require a comprehensive duplex ultrasound (DUS) with particular attention to the deep venous system where necessary. Some available international guidelines fail to define clear recommendations about optimal management of RVVs in specific situations.
In 2015, a new guideline “Neovarices” for the treatment of RVVs was developed. This document reviews the most important issues in the treatment of RVVs, presenting conclusions and recommendations from the Dutch Neovarices Guideline Committee. Recommendations about the treatment of pelvic congestion or deep venous disease and specifically recommendations covering recurrent venous ulcerative disease, found in the Dutch Venous Ulcer Guideline update will not be discussed due to the size restriction of this article. 1
The term “recidief varices” should be a Dutch translation of “recurrent varicose veins” but “recidief” in Dutch actually suggests recurrence after apparent successful treatment and ignores the natural and unavoidable progression of venous disease in its own right. So the Committee opted to use the term “neovarices.”
Neovarices is an all-embracing term for RVVs caused by technical or tactical failure, evolvement from residual varices or natural progression of varicose vein disease at different locations of the treated leg following primary intervention.
The acronym PREVAIT (PREsence of Varices After Interventional Treatment) as recommended in the VEIN-TERM transatlantic interdisciplinary consensus document was not chosen because PREVAIT seems to waive the natural progression of varicose vein disease irrespective to treatment. 2
Methods
A literature search of international guidelines, systematic and personal reviews, randomized controlled trials, prospective and retrospective cohort studies was performed using Medline, Google Scholar, and the Cochrane Library. Studies were identified using combinations of the following medical subject headings (MeSH) and free texts: recurrence, recurrent, varicose veins, neovascularization, surgery, endovenous thermal ablation, foam sclerotherapy, ambulatory phlebectomy (AP), compression, venous ulcer. Cross-references were also included when relevant. Scientific evidence for different queries was gathered by critical quality assessment of the published studies. When evidence was not available in literature, recommendations were based on committee consensus.
Quality assessment of reviewed studies.
Conclusions based on levels of evidence according to evidence-based guideline development in the Netherlands (EBRO).
International guidelines about varicose vein disease
In the clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum from 2011, RVVs are discussed in a separate chapter. 3 One recommendation was put forward: “For treatment of recurrent varicose veins, we suggest ligation of the saphenous stump, AP, sclerotherapy, or endovenous thermal ablation, depending on the aetiology, source, location, and extent of varicosity.”
During development of the NICE guideline “Varicose Veins in the Legs” from 2013, the Guideline Development Group decided not to formulate separate recommendations for “RVVs” except one regarding the Patient Information: “The patient should be informed that the chance of recurrence after treatment for recurrent varicose veins is higher than for primary varicose veins.” This is an explicit but somewhat indirect recommendation for patients with RVVs.
4
In the clinical practice guidelines of the European Society for Vascular Surgery (ESVS) about management of Chronic Venous Disease (2015), the treatment of RVVs is discussed in a small separate chapter.
5
Several recommendations were worded:
DUS is recommended for the assessment of RVVs to identify the source of recurrence. Endovenous thermal ablation, ultrasound guided foam sclerotherapy (UGFS) or phlebectomy should be considered for the treatment of symptomatic RVVs. Extensive redo surgery (including re-exploration of the groin or popliteal fossa) is not recommended as a first choice treatment in patients with RVVs.
Aetiology and pathophysiology
Understanding the different mechanisms of recurrence is imperative for successful management of RVVs and development of therapeutic strategies. 6 In studies from early patient cohorts tactical and technical failure were the most common cause of recurrence. High ligation and stripping (HL/S) was a more or less “blind procedure.” Wrong veins were removed, various sources of reflux were not identified, long refluxing saphenous stumps were left behind after surgery, junctional tributaries were overlooked, etc.7–9 The prevalence of tactical and technical errors was estimated on 29% of same site recurrence. The increasing use of DUS pre- and per-operative has decreased the rate of technical and tactical errors. But even with proven properly performed surgery, recurrence seems inevitable. An important mechanism called “neovascularization” is mentioned as the most frequent cause of recurrence. 10 The prevalence is reported to be 8–60%. 11
Neovascularization in the VEIN-TERM transatlantic interdisciplinary consensus document defined as “Presence of multiple new small tortuous veins in anatomic proximity to a previous venous intervention.” 2 It is stimulated by a wound repair mechanism influenced by hemodynamic changes after occlusion of the venous pathway. 12 Regrowth of new vessels are mostly situated in granulation tissue around the occluded stump after ligation. Stimulation of growth factors and cytokines play a causative role. Neovascularization is not always clinically important.
Several authors challenge the importance of neovascularization. Another suggested mechanism of refluxing veins in the groin after surgery is vascular remodeling by adaptive dilatation of pre-existing venous channels, in response to abnormal hemodynamic forces.13–15 In both situations, reconstitution and reconnection with incompetent accessory saphenous veins or epifascial tributaries combined with symptoms is necessary to make it clinically relevant.16,17
Fischer found a 60% incidence of junctional and circumjunctional reconnection after correct ligation of the sapheno-femoral junction (SFJ) and its related tributaries with a follow up of 34 years. 16
Strip-track revascularization after stripping of the great saphenous vein (GSV) is a common phenomenon. The mechanism clarifying the recanalization with re-endothelialization of the track is unclear. It is suggested that the presence of hematoma stimulates the release of chemotactic substances to start the process of neovascularization.18,19 Multiple venous channels in the saphenous compartment arise.
Contemporary endovenous techniques seem not to induce granulation tissue and wound repair mechanisms around the vessels are found to a lesser degree. The chance of developing reflux due to neovascularization is reduced in comparison with open surgery.20–22 However, several randomized studies which compare HL/S and endovenous laser ablation (EVLA) show the latter to have a considerably higher incidence of groin reflux, involving reflux appearing through accessory veins in long-term follow-up.22–28
Leaving a “physiologic residual stump” together with an incompetent terminal valve may not be so harmless in the long term and should be further investigated. Recurrence after thermal of chemical ablation is also influenced by recanalization of the treated trunk and persisting reflux of the SFJ or SFJ, although prospective studies about this subject are scarce. Most failures are caused by inexperienced surgeons using the wrong technique and/or treatment modality. Thermal ablation should be performed with sufficient energy and UGFS is more successful in veins with smaller diameters.29,30
In several studies, it is suggested that progression of venous disease itself significantly contributes to recurrence. 10 Primary chronic venous disease is a generalized on-going process. The aetiology is multifactorial and multidimensional and any segment of the superficial, perforating, or deep venous system can be involved. 10 The question is whether progression of venous disease may be enhanced by intervention. Creton suggests that the absence of superficial venous drainage after complete removal of varicose veins and saphenous trunk leads to more appearance of re-recurrences after surgery for recurrent GSV reflux. He suggested that this poor outcome is probably caused by the presence of a non-draining superficial venous system. 31 Turton detected new sites of reflux, which may resolve spontaneously, and occur in the early postoperative period despite adequate varicose vein surgery. He assumed a manifestation of the effect of altered venous hemodynamics in a system of susceptible veins. 14
In summary, it appears that recurrence caused by progression of disease can be facilitated by a physiological response to venous disconnection or normal wound healing or a manifestation of the effect of altered hemodynamics in a system of susceptible veins.
Diagnostics and planning
A complete medical/surgical history should be taken paying particular attention to the possibility of previous DVT and post thrombotic syndrome (PTS). Previous venous procedures should be recorded in relation to dates of RVVs occurrence. Reasons for consultation and presence of symptoms should be carefully documented including patient’s expectations from the treatment. There is no visual discrimination between recurrent or primary venous disease in varicose vein patients. Noticeable scars at specific locations will sometimes show evidence of previous surgery if the history is unclear. The assessment of the severity of vein-related symptoms and their influence on quality of life is important for treatment decisions. Measurements of health-related quality of life (e.g. SF 36, Aberdeen Quality of Life Score (AVVQ or AVVS) shows significantly worse health-related quality of life (HRQL) than is found among patients with primary varicose veins. 33 One of the reasons is that patients with RVVs, generally are older than patients with primary varicose veins.33,34
Besides history and physical examination (pelvic region and legs) DUS is of the utmost importance. It provides hemodynamic road mapping, allows for accurate assessment, and enables proper therapeutic planning. 35 Preoperative skin marking of important sources of reflux may thwart incomplete treatment. Nowadays, with complex anatomy it is not unusual to perform DUS during open surgery as well. RVVs are more common in patients with a history of DVT and PTS, which emphasizes importance of detecting deep venous obstruction and not to confuse RVVs with important venous collaterals. DUS of the pelvic region by an experienced investigator is therefore mandatory. 36 If treatment of deep venous obstruction is considered, necessary additional anatomic information can be obtained by computed tomography venography (CTV) or magnetic resonance venography (MRV). 37
Open redo venous surgery
Prior to the introduction of endovenous (thermal) ablation techniques extensive recurrent venous disease was mainly treated by open surgery. Historically, technical or tactical failures were the main reason for redo surgery. In most cases, exploration of the groin or popliteal fossa and removal of all RVVs were performed which was a complicated time-consuming procedure. 32 Open interventions through scarred tissue has a higher complication rate, with more wound infections and lymphatic leakage. 38 The recurrence after redo surgery is much higher than after primary surgery. 32 Some authors advise an indirect approach to avoid scar tissue exploration. Lateral and medial exploration is suggested to improve the flush ligation of the residual stump and refluxing branches.43–45
To prevent re-recurrence some authors describe barrier techniques to prevent reconnection of axial refluxing veins with the residual stump of the GSV. There are a few studies advocating a synthetic patch or muscle fascia flap to seclude the ligated stump.46,47 Using foreign material can potentially give serious early and late complications. 39 Two randomized studies (despite being small and underpowered) failed to demonstrate any apparent benefit from barrier techniques.41,42
Endovenous thermal ablation
In comparison with the treatment of primary varicose veins, there is relatively a small number of publications about the use of endovenous thermal ablation in patients with RVVs.49–53 There is only one small randomized study from Hinchliffe. 48
HL/S and radiofrequency ablation (RFA) were compared in 16 patients with bilateral GSV reflux. One leg was treated with HL/S, the other with VNUS Closure in the same patient. Tributaries were removed with AP. Results were identical after 12 months (100% occlusion), but the VNUS Closure procedure took less time with less post-operative pain and bruising.
Groenendael showed in two retrospective cohort studies, where EVLA of GSV and small saphenous vein (SSV) was compared with open surgery that the anatomic results were similar. In the SSV study, technical success was achieved in 94% of surgically treated patients and in all EVLA-treated patients. In the GSV study with 25 weeks of follow-up, re-recurrences occurred in 29% of the surgically treated patients and in 19% of the EVLA-treated patients. The group of EVLA treated patients had fewer complications than the group after open surgery and shorter term return to work (2 vs. 5 days).49,50
Theivacumar described a series of 95 patients (104 legs) where recurrent reflux of the GSV, SSV, accessory anterior saphenous vein and incompetent perforators (IPV) were treated. Follow-up at 12 months showed an occlusion rate of 100%. There was a marked improvement of the AVSS from 14.2 to 2.1 and venous clinical severity score (VCSS) from 4 to 1. 51 In two other retrospective cohorts with recurrent truncal reflux 100% success was achieved with a follow up from several weeks to 18 months.52,53
Foam sclerotherapy
UGFS is a widely used treatment for RVVs. Several cohort studies have been published but no randomized controlled trials are available.54,56–61 The technique is minimally invasive, well tolerated by the patient and does not require (local) anesthesia.
59
If necessary, this technique can be easily repeated, as follow-up procedures are as easy to perform as the first treatment. RVVs are often tortuous. UGFS does not require the introduction of stiff catheters or fibers. Each separate source of reflux can be targeted with UGFS through various strategic access points. UGFS can be combined with open surgery and thermal ablation (hybrid procedures) in order to eliminate multiple sources of reflux (Figure 1).
55
Darvall concludes from a retrospective cohort study of 73 patients with recurrent truncal reflux that 100% of the reflux in truncal veins was eliminated with UGFS in one or two sessions. One procedure was sufficient in 93% of patients. After 12 months recanalization occurred in only 9–12% of the treated legs.
54
Coleridge Smith achieved similar results in 267 patients with a follow-up of 6 months.
59
Long-term results of specifically treated RVVs are not available. From several randomized controlled trials, we learn that anatomic results of truncal vein ablation for primary truncal vein incompetence with UGFS is clearly inferior to open surgery or endovenous thermal ablation. In longer terms, the quality of life detoriates over time.22,62,63 But in recurrent disease open surgery causes significant more complications than endovenous procedures.
32
Thermal ablation is technically not always feasible. In vulnerable areas like the popliteal fossa UGFS is the first choice to avoid potential serious complications inherent to open surgery.
57
Often repeat sessions are required to get a satisfactory result. Foam sclerotherapy is perfectly suited for temporary occlusion of refluxing vessels in an ulcer bed promoting ulcer healing.
64
Hybrid procedure (EVLA and foam) for treatment of AASV recurrence after previous GSV stripping. (a) Neovascular channels below groin. (b) Reflux in neovascular channels and residual GSV stump. (c) Preparing 3% foam after applying tumescent around AASV with radial laser fiber. (d) Infusion of foam through sideway arm of 6FR sheath. (e) Foam located in GSV stump and neovascular channels. (f) AASV after EVLA and foam closure.
Ambulatory phlebectomy
There is little evidence about the beneficial role of AP as a solitary treatment for RVVs. In several studies, this treatment is performed complimentary to open ligation, foam, or thermal ablation.31,48,55
In a comparative retrospective study of Pittaluga et al. extensive AP in 195 limbs (109 patients) as a single treatment, was compared to redo surgery of the SFJ in 134 limbs (106 patients). With 3 years follow-up, a Kaplan–Meier life table analysis showed absence of inguinal reflux in 90.8% of the redo group versus 92.9% in the AP group. Absence of recurrence was respectively 90.8% versus 91.9%. The venous disability score (VDS) score after 3 years showed a significant (p = 0.02) improvement in the AP group, compared with the redo group. Further benefits in the AP group were significantly less complications, the ability to use local anesthesia, and shorter recovery time. 40
In a retrospective study from Creton, 129 patients with RVVs treated with a hybrid therapy of foam sclerotherapy and AP had 93% obliteration at 40 days. About 24 of the 129 patients also had a ligation of the SFJ or SPJ junction under local anesthesia. 55
Treatment of IPVs
There is some controversy about the role of IPV as a cause of RVVs.67,68 Some publications suggest that there is a relationship between IPV’s and recurrence.69,70
Bush showed in a series after thermal ablation in 17 of 126 patients a conjunction between partially or totally recanalized saphenous trunks and IPVs. Perforator pathology was present in 64% of patients. 70
None of the studies corroborate a causative relationship between IPV and varicose veins. With incompetent IPVs transporting blood from the deep system, there are always nonfunctioning valves in a local superficial venous trunk. Hence, when reflux is found both in an IPV and an associated section of truncal vein or axial tributary, there is no distinguishing between cause and effect. 68 There is no level 1 or 2 evidence that treatment of IPV’s reduce the chance of RVVs. Good results with the treatment of IPV’s in patients with chronic venous insufficiency have been described, but these procedures were always combined with surgery of the superficial venous system.71–73 It remains unknown if solitary perforator ablation (after previous superficial vein ablation) can prevent progression of varicose vein disease or ulcer development in an early phase. It cannot be recommended that it should be employed routinely and can only be justified in patients with persistent venous ulceration after superficial vein reflux and post-thrombotic occlusive disease has already been cured or excluded. 65 Open surgery in venous ulcer disease is contraindicated in most cases because of the high incidence of serious wound complications in comparison with subfascial endoscopic perforator vein surgery (SEPS). 74 Van Gent concluded from a long-term follow-up that well-performed SEPS reduces the venous ulcer recurrence rate significantly, indicating the clinical importance of incompetent perforating veins in patients with an active venous ulcer. 66 The development of percutaneous minimal-invasive ablation techniques such as thermal, foam, glue especially designed for IPV occlusion makes it appealing to treat symptomatic RVVs which are connected to an IPV.68,75–78 However, nondetected veins and limited durability are challenging. Supporting studies are small with a short-term follow-up. More robust and better-designed studies are needed. O’Donnell concluded that perforator ablation does not prevent recurrence of varicose veins meaning that treatment has to be tailored to when symptomatic recurrent veins appear. 21 However, because we have evidence that treatment of IPV’s can prevent ulcer recurrence it is wise to investigate if prophylactic IPV ablation in advanced stages of venous disease can subdue venous ulcer development. Momentarily UGFS, AP of the varicose network and thermal ablation of residual truncal veins connected to perforators can be employed in improving symptoms and clinical signs.49,51
Percutaneous occlusion of IPVs is only recommended in advanced venous disease if extensive treatment of superficial incompetence is ineffective and when there is no deep venous obstruction.
Compression therapy in superficial vein disease
In most patients with symptomatic RVVs some form of compression therapy, usually by therapeutic elastic hosiery can be useful to treat symptoms.79,80 However, patient noncompliance is high when it comes to wearing described compression garments. 79 There are no specific publications about compression therapy for patients with RVVs. Compression therapy is considered the cornerstone of treatment for venous disease, but only if invasive therapy is not possible or insufficient. 81 There is no evidence that compression decreases progression or prevent recurrence of varicose veins after previous treatment. 80
Treatment plan for RVVs
After assessment of symptoms, quality of life and staging with physical examination, DUS is performed. Because multiple sites of incompetence are observed in the majority of patients with RVVs an extensive DUS investigation is carried out identifying all sources of reflux and varicose network. One must always keep in mind the possibility of deep venous obstructive disease.
An excellent practical ultrasound guideline is described in the chapter “DUS imaging after surgical treatment” in the UIP consensus document.
82
The anatomic distribution of varicose veins, their relationship to the main reflux escape points from the deep venous system and the extensiveness of the varicose network or neovascularization further define the selection of appropriate invasive therapy. A staged or combined hybrid approach is based on symptoms, severity of disease, risk profile, patient preference, and expectation of improved outcome. Open groin surgery has to be avoided if less invasive treatments suffice (Figure 2).
Flowchart: treatment selection for RVVs.
Summary of recommendations
In the management of RVVs thermal ablation, foam sclerotherapy and AP is preferred to redo open groin surgery. Foam sclerotherapy is recommended in tortuous RVVs either as a single treatment or complimentary to thermal ablation, AP and open surgery as a hybrid procedure. AP should be considered in symptomatic patients with RVVs either as a single treatment or complimentary to thermal ablation, foam sclerotherapy and open surgery as a hybrid procedure. Percutaneous occlusion of IPVs is only recommended in advanced venous disease if extensive treatment of superficial incompetence is ineffective and when there is no deep venous obstruction. Compression therapy is not recommended as the primary and sole treatment of symptomatic RVVs in patients who clearly would benefit from intervention which eliminate reflux and reduce venous hypertension.
Acknowledgements
DCOP Guideline Development Group Neovarices
Footnotes
Author contributions
Review conceived and drafted by J.A.L. I.M.T. reviewed and edited the manuscript. Members of the DCOP Guideline Development Group Neovarices did data acquisition and analysis.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
