Review Article
What is effective care for varicose veins?
Phlebology 2016, Vol. 31(1S) 80–87 ! The Author(s) 2016 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0268355516632999 phl.sagepub.com
Mark H Meissner
Abstract Varicose veins affect one-quarter to one-third of Western adult populations and consume an increasing amount of health care resources. Much of this increased utilization has been driven by the advent of minimally invasive technology including endovenous thermal ablation, foam sclerotherapy, and more recently mechanicochemical and cyanoacrylate glue ablation. This has largely been driven by patient and physician preferences in the absence of robust evidence that one therapy is truly superior to another. This partially arises from misunderstandings about appropriate outcomes measures and what truly constitutes effective treatment of varicose veins. Technical outcomes, such as saphenous closure rates, have frequently been used as surrogates for effective treatment but are poorly correlated with symptom improvement, quality of life, and risk of recurrence. Although there does appear to be a trend towards higher recurrence with ultrasoundguided foam sclerotherapy, the data are occasionally conflicting and there does not appear to be substantial differences between the various modalities. Similarly, there do not appear to be major differences in late quality of life measures between these treatment options. As long-term differences in recurrence and quality of life are small, overall cost effectiveness is driven primarily by initial treatment costs and ultrasound-guided foam sclerotherapy is the most costeffective strategy in many models. However, there continues to be substantial uncertainty surrounding cost estimates and other factors of importance to the patient may ultimately drive treatment decisions. The benefits of some adjuncts to the treatment of axial superficial reflux, such as the concurrent versus staged management of tributary varicosities, remain ill-defined while that of others, such as routine post-procedural ultrasound surveillance and compression, need critical re-evaluation.
Keywords Varicose veins, quality of life
Chronic venous disease (CVD) is among the most common afflictions among Western populations and it has been estimated that as many as 164 of every 1000 people seek medical advice for venous problems.1 Varicose veins are the most prevalent clinical manifestation of CVD, occurring in one-quarter to one-third of Western adult populations.2,3 Prevalence figures in Western populations have varied from 10% to 15% when only pronounced or medically significant varices are considered to 30%–50% when all types of disease are included.4,5 A trial of compressions stockings is often considered the initial standard of care for the management of varicose veins and, while effective in controlling edema, healing venous ulcers and reducing their recurrence, the evidence suggests that it has limited efficacy in the management of C2 disease. A wide variety of surgical procedures have evolved over the last century to address the problem of varicose veins. Trendelenburg’s 1890 description of double ligation of
the saphenous vein at the junction of the upper and middle third was followed by Homans’ description of flush ligation of the saphenofemoral junction 1916. Charles Mayo popularized excision of the great saphenous vein (GSV) in the 1890s, such techniques eventually being replaced by a variety of extra- and intra-luminal stripping techniques in the early 20th century. The flexible intraluminal stripper, with direct excision of varicose clusters, was introduced by Myers in 1947 and remained the standard of care through the last half of the 20th century.
Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, WA, USA Corresponding author: Mark H Meissner, Department of Surgery, Box 356410, University of Washington School of Medicine, 1959 NE Pacific Street, Seattle, Washington 98195, USA. Email: [email protected]
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These treatment paradigms were dramatically altered with the introduction of endovenous thermal ablation techniques (laser and radiofrequency) in the late 1990s. Percutaneous ablation of the GSV, using either radiofrequency or laser energy, has become a widely accepted alternative to stripping. Initial success rates of 95% are standardly reported in association with excellent patient acceptance. Most series have documented less post-operative pain, a more rapid return to work and usual activities, and an objectively improved quality of life early after the procedure. Minimally invasive treatment options have now expanded beyond endovenous thermal ablation and include foam sclerotherapy, mechanicochemical ablation, and cyanoacrylate glue. Unfortunately, both patient and physician acceptance of these minimally invasive procedures has often been driven by early technical reports in the absence of clinical data demonstrating significant early or late benefits in comparison to standard surgical procedures. Early trials are often highly focused, leaving important clinical issues unresolved, and frequently concentrate on short-term surrogate outcome measures.6 Over 90% of new medical devices in the United States are approved through the 510 (k) process, largely requiring demonstration that safety and efficacy are substantially equivalent to a marketed predicate device.7,8 Unfortunately, although this process is effective in encouraging the development of new technology and does provide some mechanism for insuring safety, it often sheds little light on effectiveness with respect to clinically relevant outcome measures.
What are the important determinants of effective vein care To be useful in guiding medical decision making, studies must not only be scientifically sound they must be clinically relevant. Although study methodology is important in determining the quality of evidence supporting any treatment, other important considerations include study limitations (concealed allocation, blinding, loss to follow-up, etc.), consistency of treatment effects, imprecision, and indirectness.9 Indirectness refers to the extent to which features of the study are similar to the question of interest. There are several potential sources of indirectness, including the use of surrogate markers rather than outcomes of importance to the patient and the lack of direct comparisons between two alternative therapies. Direct evidence is the most certain evidence and comes from studies with subjects, treatments, and outcome measures similar to the question of interest. Unfortunately, much venous research continues to rely on indirect evidence, particularly through the use of surrogate outcome
measures. Consideration of appropriate outcome measures is critical to the question of what constitutes effective vein care. Clinically important outcomes measure how a treatment improves a patient’s function, symptoms, quality of life or survival.10 In contrast, surrogate outcome measures are substitutes for outcomes of importance to the patient or health care system. Such measures may include laboratory, radiographic, or other diagnostic tests; physical signs; physiologic parameters; and similar substitutes for important outcome measures.10 Surrogate outcomes often have the advantages of being easier, less costly or less invasive to measure; may require a shorter period of follow-up; and may require smaller samples sizes. However, they must be used and interpreted with caution. Implicit in the use of surrogate measures is that they accurately predict, rather than are simply correlated with, a clinically important outcome.10 Unfortunately, surrogate outcome measures are often based on an unproven, assumed relationship between the surrogate marker and an accepted clinical outcome.11 They may be appropriate in early feasibility studies, in screening the potential of new interventions, and in phase II clinical trials.10,12 However, studies using surrogate outcome should not alter the standard of care. Such studies should serve as the basis for further trials using clinically relevant (or patient important) outcomes. Surrogate outcome measures in chronic venous disease include technical outcomes, such as closure rates, reflux elimination, and hemodynamic improvement as well as clinician-observed outcomes that may or may not be of importance to the patients. Technical outcomes may be important in validating the technical efficacy of a new procedure but are not of primary importance to the patient and cannot alter the standard of care. Such outcomes are particularly attractive in the field of chronic venous disease, where the measurement of clinically relevant outcomes may require years of follow-up. Clinical outcomes are frequently derived from the physician’s observation of the effects of treatment and include elements such as bruising and varicose vein recurrence, and ulcer healing and recurrence. Clinical outcomes can also be captured in validated instruments such as the Venous Clinical Severity Score (VCSS).13,14 Unfortunately, patient’s and physician’s perception of the impact of disease on quality of life is often significantly different. Physicians tend to specifically underestimate the impact of chronic venous disease on patient-reported quality of life.15 Such measures are occasionally appropriate when the captured clinical feature, such as symptomatic varicose vein recurrence, uniformly affects quality of life among patients. However, the importance of many clinical outcomes,
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such as post-operative bruising, differs between patients. Such outcomes further fail to capture the entire burden (physical, psychological, social) of disease and are often poorly correlated with overall quality of life. Quality-of-life instruments directly measure the functional effect of a disease and its treatment on a patient and are probably the most valid outcome measure for chronic diseases.16 Such instruments best measure the impact of the entire burden of disease on the patient. A number of generic and venous diseasespecific quality-of-life instruments17–20 are available. Direct reporting of measures demonstrated to be of importance to the patient, often referred to as a patient reported outcome (PROM), is a critical feature of both types of instrument. Generic instruments are not specific for any disease and can be applied to a range of patient populations. Advantages of the generic instrument include the fact that they allow comparison to both standardized populations and patients with other diseases, they account for the impact of comorbidities on the disease process, and perhaps most importantly, they are sensitive to any adverse effects of treatment. They are, however, relatively insensitive to the effects of disease-specific treatment. In contrast, disease-specific instruments include key features of the index disease and are thus sensitive to the positive effects of treatment. They may, however, be insensitive to adverse treatment effects. Generic and disease-specific instruments are optimally used in combination. Additionally, in times of increasing health care costs and limited resources, the burden of any treatment on the health care system must also be considered. Cost-effectiveness analysis uses improvements in quality-adjusted life years (QALYs) as a universal currency that extends across disease states. Health state valuations are derived from specific generic quality-of-life instruments (EQ-5D, SF6D, HUI) such that one QALY corresponds to one year of perfect health. The impact of treatment on QALYs is then calculated as the product of the years of life remaining and the quality of those years scored from 0 to 1. A cost-utility ratio can then be calculated as the cost to maintain one year of perfect health.
How effective are treatments for chronic venous disease A variety of techniques are available for the treatment of primary saphenous reflux including high ligation and stripping (HL/S), thermal ablation using laser (endovenous laser ablation, EVLA) or radiofrequency energy (radiofrequency ablation, RFA), mechanicochemical ablation, and ultrasound-guided foam sclerotherapy (UGFS). The question of which of these alternatives constitutes the most effective vein care depends
somewhat on perspective. From the patient’s perspective a durable clinical result with the greatest early and late improvement in symptoms and quality of life, least time lost from work and usual activities, lowest risk of recurrence and minimal out-of-pocket costs are important. From a social or payer’s perspective, effective vein care is likely that which provides the greatest improvement in quality of life at the least cost. From this perspective, a less-than-perfect result (some risk of recurrence, some decreased early quality of life) may be acceptable if these issues are easily and inexpensively managed. Good quality evidence does suggest that the interventional management of varicose veins is superior to conservative management with compression stockings. Among 246 patients with extensive varicose veins and GSV reflux randomized to conservative measures or HL/S and phlebectomy in the REACTIV trial,21 significantly greater improvement in symptoms and quality of life was demonstrated in the surgical group. Surgery was judged to be cost-effective with an incremental cost-effectiveness of £1936 per QALY over a 10-year period. Similarly, Sell et al.22 randomized 153 patients to either compression or PIN stripping, phlebectomy, and perforator interruption if appropriate. At two years there was significantly greater improvement in VCSS among those treated with surgery. Health-related quality of life, assessed with the Aberdeen varicose vein score, did not change in the compression group but significantly improved in those undergoing surgery. Given the inferior outcomes, there is little data to support compression stockings alone as the primary management of C2 disease in most patients. With respect to the efficacy of the minimally invasive interventional techniques, several randomized trials have evaluated the surrogate outcome of saphenous vein occlusion or closure. Among 500 patients with C2-C4 disease randomized to EVLA, RFA, UGFS, or HL/S, all done in a clinic setting under tumescent anesthesia, saphenous occlusion rates at one year were significantly lower for UGFS (83.7%, p < 0.001) and equivalent for EVLA (94.2%), RFA (95.2%), and HL/S (95.2%).23 At five years, patency of the GSV was identical among limbs treated with EVLA (17.9%) and HL/S (10.1%, p ¼ .21).24 Several metaanalyses have reached similar conclusions. Among 28 randomized trials variously comparing surgery, RFA, EVLA, and UGFS, only UGSF was associated with a significantly higher risk of primary failure (RR 2.4, 95% CI 1.6–3.6) in comparison to surgery.25 Despite the importance of this data, it is not clear that technical outcomes are highly associated with patient-important outcomes. In a study of proprietary microfoam sclerosant, symptom improvement occurred in both those with and without technical success as
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defined by ultrasound criteria.26 The correlation between technical success and patient-reported symptom improvement using a validated instrument (VVSymQ) was weak (correlation coefficient 0.26). Similarly, in a large registry including 1222 limbs treated with RFA, clinical improvement was noted in in 70%–80% of the 185 limbs with anatomic failure at five years and only 10.3% of these limbs required reintervention.27 Additionally, recurrent reflux in the GSV24 and clinical recurrence of varicose veins have not been clearly related to technical failure.28 Finally, there is no clear relationship between GSV occlusion and either the VCSS or quality of life at five years. Although unrelated to long-term outcomes, postoperative pain scores have also been used to support the efficacy of one treatment modality in comparison to another. RFA (mean 10-point visual analog pain score 1.21 1.72) and UGFS (1.60 2.04) are associated with lower pain scores over the first 10 days after the procedure than EVLA (2.58 2.41) or HL/S (2.25 2.23).23 Although the clinical relevance of these small differences in pains cores is unclear, patients undergoing RFA or USGFS did return to normal activities 1 to 3 days earlier than those undergoing EVLA or stripping. A meta-analysis of 21 randomized clinical trials similarly suggested less early postoperative pain among patients undergoing either EVLA (median difference –0.6, –1.1 to –0.2) or RFA (–1.6, –2.1 to –1.1) in comparison to surgery.25 In comparison to surgery, return to work and usual activities was also significantly shorter among patients undergoing RFA, but not EVLA. However, as varicose veins are a chronic disease, transient conditions such as post-operative pain are relevant only if long-term improvements in patient-important outcomes are at least equivalent to the comparative therapy. Similarly, most post-operative complications are rare and transient, impacting the efficacy of varicose vein care only if they reduce long-term quality of life. However, as for post-operative pain, they may be important considerations if the efficacy of two modalities is otherwise equivalent and the endovenous techniques do appear to be associated with fewer complications than HL/S. In a meta-analysis of 19 studies, endovenous thermal ablation was associated with 70% and 50%–60% relative risk reductions in the incidence of infection and hematoma in comparison to surgery.25 There was no difference in the incidence of paresthesias, although RFA was associated with a 2.3 (1.1–5.0) higher risk of superficial thrombophlebitis that was not seen with EVLA. Late complications including persistent dysesthesias and hyperpigmentation are also rare and occur with similar frequency with EVLA and HL/S.29 Recurrence is a well-recognized risk of superficial venous procedures and approximately 15%–20% of
all varicose vein procedures are done for recurrence.28 Rates of recurrence have been reported to be up to 33% at two years and as high as 41% and 70% at 5 and 10 years, respectively.30 Patients’ report concerns regarding recurrence as being among the most important factors in choosing among treatment modalities.31 Furthermore, as early recurrence of varicose veins (within one year) is associated with significant reductions in quality of life and overall satisfaction with the procedure, it is a patient-important outcome.28 The rates of recurrence between the various modes of treating saphenous incompetence do not seem to be substantially different. Although UGFS is associated with significantly higher rates of saphenous patency at one year (16.3%), no differences in recurrent varicose veins have been demonstrated between EVLA (11.6%), RFA (7.3%), UGFS (13.8%), and HL/S (14.8%).23 Similarly, recurrent varicose veins were noted in 46.6% and 54.6% of patients five years after EVLA or stripping respectively (p ¼ .72) and resulted in reoperation in 38.6% and 37.7% of limbs (p ¼ .99).24 A second randomized trial reported equivalent rates of clinical recurrence among those undergoing EVLA (54%) and HL/S (45%, p ¼ .15) at five years follow-up. Although most recurrences required no intervention, additional procedures were significantly more common in those treated with EVLA (51% of recurrences treated) in comparison to HL/S (33%, p ¼ .04). A systematic review and meta-analysis has also suggested no significant difference in the risk of recurrence between EVLA (RR 0.6, 0.3–1.1) or RFA (RR0.9, 0.6– 1.4) and surgery.25 However, despite these largely consistent results, at least one randomized trial28 and two network meta-analyses30,32 have suggested lower recurrence rates in patients undergoing thermal ablation. Among 280 patients randomized to EVLA or HL/S, recurrence was significantly more frequent in patients undergoing HL/S (20.4%) in comparison to EVLA (4.0%, p < .001).28 At least part of this difference was likely related to stripping just below the knee versus EVLA to the most distal point of reflux, the majority of recurrences occurring in the below-knee GSV in the stripping group. Additionally, there was no difference in the number or type of additional procedures performed for recurrence after HL/S or EVLA. A network meta-analysis of eight studies suggested UGFS to have the highest probability of recurrence, HL/S an intermediate probability, and EVLA the lowest probability.32 A second, larger meta-analysis including 23 trials reported similar results – a trend toward higher rates of recurrence after USGFS followed sequentially by RFA and EVLA.30 Although rates of recurrence are similar, the patterns of recurrence are somewhat different for stripping and
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the endovenous thermal techniques. Recurrences related to a previously treated GSV (same site recurrence) are more common after EVLA than HL/S.29 Groin recurrences, related to neovascularization, are much more common in patients undergoing HL/S and account for almost half of clinical recurrences in some28 but not all29 trials. Recurrence associated with thigh perforators also appears to be more frequently associated with HL/S.24,28 Groin recurrences after thermal ablation are largely related to disease progression and new anterior accessory saphenous vein (AASV) reflux. Merchant et al.27 described three patterns of anatomic groin recurrence five years after RFA – initial, persistent non-occlusion of the GSV; recanalization of an initially occluded GSV; and reflux in a groin tributary, usually an accessory saphenous vein. Although recanalization and new groin reflux were associated with a three- to four-fold increased risk of recurrent varicosities, initial failure was not. As discussed above, patient-reported quality-of-life outcomes best account for the impact of all aspects of a chronic disease on the patient. In a randomized trial, Rasmussen et al.23 found that patients undergoing EVLA or stripping had more pain and discomfort at three days than those treated with UGFS or RFA. However, all modalities resulted in equivalent improvement in quality of life from one month through one year. Similarly, no differences were found in diseasespecific (Aberdeen Varicose Vein Severity Score) or generic (SF-36) quality of life five years after EVLA or stripping.24 A second large randomized trial29 also found no difference in disease-specific quality of life, measured by the CIVIQ-2 instrument, between EVLA and stripping at five years. Finally, a meta-analysis including six studies comparing EVLA and surgery also found no significant differences in quality of life measured by the AVVSS at 2 to 24 months.25 As all of the treatment modalities – EVLA, RFA, UGFS and HL/S – result in similar long-term improvements in quality of life, the most effective procedure may ultimately be that which is least expensive. Although the data suggest a higher risk of primary technical failure with UGFS, the lower cost, safety, and repeatability will undoubtedly favor its use in some situations. Rasmussen et al.23 found that when only procedure-related costs were considered, RFA was the most and USGS the least expensive option. When the cost of lost work was included, EVLA and HL/S became the most expensive while UGFS remained the least expensive. However, in a network meta-analysis, both surgery and thermal ablation resulted in more QALYs than UGFS.32 Over a fiveyear time horizon, which included initial treatment, any early retreatment, and recurrence, thermal ablation cost an additional £151 in comparison to UGFS.
However, with an incremental cost effectiveness ratio (£3161 per QALY gained) well below the UK willingness to pay threshold, thermal ablation was judged to be the most cost-effective treatment strategy. It must be noted, however, that the probability of UGFS being cost-effective increases as the willingness to pay threshold falls and may exceed that of thermal ablation at values below £10,000 per QALY gained. In contrast, a second meta-analysis found that, because differences in QALYs between the various treatments were quite small, cost-effectiveness was driven primarily by cost differences between modalities.30 Although there is considerable uncertainty surrounding the cost of treatment, UGFS was judged to be most cost effective.
Adjuncts to effective vein care Although the management of truncal venous incompetence remains a cornerstone in the management of superficial venous disease, several adjuncts, supported by variable amounts of evidence, have been incorporated into modern treatment strategies. These include the concurrent or staged management of tributary varicosities, routine post-procedural compression, and early post-operative ultrasound surveillance. As all of these adjuncts have implications for patient comfort, quality of life, and convenience, they are an important consideration in effective vein care. Concurrent versus staged management of varicose tributaries continues to be controversial. Treatment of tributaries with phlebectomy or sclerotherapy at the same time axial reflux is treated may lead to overtreatment and, indeed, among 54 limbs followed for six months after RFA of the GSV, 28.4% of varices resolved and 41% of limbs required no further treatment.33 However, staged tributary management may also require secondary procedures with associated patient inconvenience, reduced quality of life, and increased societal costs related to time lost from work and usual activities. Most patients (71%) do desire treatment in a single visit.31 The results of small randomized trials have been conflicting, but a meta-analysis of four comparative studies evaluating the timing of tributary intervention showed a non-significant trend towards fewer procedures among those undergoing simultaneous tributary intervention (Odds ratio 0.734, p ¼ 0.339), although heterogeneity was very high (I2 81%).34 Disease-specific quality of life was, however, significantly improved at 6 weeks, but not at 12 weeks, in those undergoing simultaneous treatment. Although confounded by the variable use of general anesthesia, there does not appear to be any difference in venous thrombotic complications between the two strategies. The advent of thermal ablation techniques moved duplex ultrasound from a primary diagnostic modality
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to a vital therapeutic adjunct to the procedure. As it was incorporated into the procedure, it is not surprising that early results were often routinely evaluated using ultrasound. The importance of ultrasound follow-up was further supported by early reports of saphenofemoral thrombus extension (Endothermal Heat Induced Thrombosis, EHIT) in as many as 16% of patients.35 This ultimately led to several classification schemes for such thrombus extensions.36 However, rates of thrombotic complications have progressively fallen as experience with these techniques has accumulated,34 such that recent literature suggests rates of DVT, PE, and EHIT in as low as 0.2%, 0.1%, and 0.5–0.8%, respectively.37 Most of these thrombi are small, asymptomatic, and resolve relatively rapidly, suggesting that they represent direct extension from an area of injury rather than true systemic activation of coagulation. Data from trials of proprietary microfoam26 further suggests that many of these thrombi have a relatively benign prognosis regardless of treatment. Finally, routine screening for and subsequent treatment of these thrombi often fails to account for the potential harms of therapy including patient inconvenience and rare bleeding complications. The often accepted policy of routine ultrasound screening after endovenous procedures may contribute little to the effectiveness of vein care and needs further critical evaluation. Post-procedural compression is often routinely prescribed after treatment of superficial venous insufficiency. Although compression may be theoretically valuable in improving technical outcomes; reducing morbidity due to ecchymosis, pigmentation, and deep venous thrombosis; and reducing post-operative pain, this is supported by little data. Among 104 patients undergoing inversion stripping and randomized to compression bandages for three days or compression bandages followed by stockings for four weeks, there was no significant difference between groups in visual analog pain scores at two or four weeks.38 Among 93 patients randomized to compression stockings for 48 hours or seven days after EVLA, there was no difference in saphenous closure rates, although visual analog pain scores were significantly lower at one week, but not at six weeks, in those randomized to stockings for seven days.39 As there do not seem to be substantial differences in technical outcomes with the routine use of post-procedural compression, it may be reasonable to discuss the potential benefits of reduced postoperative pain versus the inconvenience of wearing stockings with the patient.
dramatically changed the clinical management of varicose veins. Early adoption of these techniques has been largely driven by physician and patient preferences based on surrogate technical outcomes that often correlate poorly with patient important outcomes. Fortunately, although it remains incomplete, data regarding the more important benefits of these procedures is accumulating. The most effective treatments for C2 disease are those that provide the most patient-important benefits including minimal post-operative discomfort, rapid return to usual activities, a low rate of recurrence, and the greatest long-term gain in quality of life. The available data suggest that all of the minimally invasive procedures, including EVLA, RFA, and UGFS, are clinically effective alternatives to HL/S. Although differences in QALYs between the procedures are small, they do marginally favor the less invasive modalities over surgery. The technical results of UGFS are inferior to those of the thermal techniques, but it does have the advantage of being minimally invasive, inexpensive, and well-tolerated. Although retreatment is associated with patient inconvenience and procedural discomfort, overall payer costs are more closely related to the initial cost rather than those of retreatment.30 When analyzed from the payer’s perspective, UGFS is likely the most cost-effective treatment option. However, there is substantial uncertainty surrounding these figures, leading some30 to conclude that other factors of importance to the patient may outweigh cost alone.30 With regards to adjuncts to the treatment of truncal varicosities, there is little definitive evidence supporting simultaneous versus delayed management of tributaries with sclerotherapy or phlebectomy. Simultaneous tributary intervention is preferred by patients and is associated with early, but not sustained, improvements in quality of life. The incidence of thrombotic complications has progressively decreased as experience with endovenous ablation has increased and the value of early routine postoperative screening, particularly when balanced against the inconvenience and potential harms, should certainly be questioned. Although the use of post-operative compression stockings beyond two days may improve early patient discomfort, it has no impact on technical success and the choice to continue compression should likely be left to a well-informed patient. 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.
Summary
Funding
The introduction of minimally invasive techniques for the management of axial superficial reflux has
The author(s) received no financial support for the research, authorship, and/or publication of this article.
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31. Shepherd AC, Gohel MS, Lim CS, et al. The treatment of varicose veins: an investigation of patient preferences and expectations. Phlebology 2010; 25: 54–65. 32. Marsden G, Perry M, Bradbury A, et al. A cost-effectiveness analysis of surgery, endothermal ablation, ultrasound-guided foam sclerotherapy and compression stockings for symptomatic varicose veins. Eur J Vasc Endovasc Surg 2015; 50: 794–801. 33. Monahan DL. Can phlebectomy be deferred in the treatment of varicose veins? J Vasc Surg 2005; 42: 1145–1149. 34. Lane TR, Onida S, Gohel MS, et al. A systematic review and meta-analysis on the role of varicosity treatment in the context of truncal vein ablation. Phlebology 2015; 30: 516–524. 35. Hingorani AP, Ascher E, Markevich N, et al. Deep venous thrombosis after radiofrequency ablation of greater saphenous vein: a word of caution. J Vasc Surg 2004; 40: 500–504.
36. Jones RT and Kabnick LS. Perioperative duplex ultrasound following endothermal ablation of the saphenous vein: is it worthless? J Invasive Cardiol 2014; 26: 548–550. 37. Dermody M, Schul MW and O’Donnell TF. Thromboembolic complications of endovenous thermal ablation and foam sclerotherapy in the treatment of great saphenous vein insufficiency. Phlebology 2015; 30: 357–364. 38. Houtermans-Auckel JP, van Rossum E, Teijink JA, et al. To wear or not to wear compression stockings after varicose vein stripping: a randomised controlled trial. Eur J Vasc Endovasc Surg 2009; 38: 387–391. 39. Bakker NA, Schieven LW, Bruins RM, et al. Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial. Eur J Vasc Endovasc Surg 2013; 46: 588–592.
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What is effective care for varicose veins?
Phlebology 2016, Vol. 31(1S) 80–87 ! The Author(s) 2016 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0268355516632999 phl.sagepub.com
Mark H Meissner
Abstract Varicose veins affect one-quarter to one-third of Western adult populations and consume an increasing amount of health care resources. Much of this increased utilization has been driven by the advent of minimally invasive technology including endovenous thermal ablation, foam sclerotherapy, and more recently mechanicochemical and cyanoacrylate glue ablation. This has largely been driven by patient and physician preferences in the absence of robust evidence that one therapy is truly superior to another. This partially arises from misunderstandings about appropriate outcomes measures and what truly constitutes effective treatment of varicose veins. Technical outcomes, such as saphenous closure rates, have frequently been used as surrogates for effective treatment but are poorly correlated with symptom improvement, quality of life, and risk of recurrence. Although there does appear to be a trend towards higher recurrence with ultrasoundguided foam sclerotherapy, the data are occasionally conflicting and there does not appear to be substantial differences between the various modalities. Similarly, there do not appear to be major differences in late quality of life measures between these treatment options. As long-term differences in recurrence and quality of life are small, overall cost effectiveness is driven primarily by initial treatment costs and ultrasound-guided foam sclerotherapy is the most costeffective strategy in many models. However, there continues to be substantial uncertainty surrounding cost estimates and other factors of importance to the patient may ultimately drive treatment decisions. The benefits of some adjuncts to the treatment of axial superficial reflux, such as the concurrent versus staged management of tributary varicosities, remain ill-defined while that of others, such as routine post-procedural ultrasound surveillance and compression, need critical re-evaluation.
Keywords Varicose veins, quality of life
Chronic venous disease (CVD) is among the most common afflictions among Western populations and it has been estimated that as many as 164 of every 1000 people seek medical advice for venous problems.1 Varicose veins are the most prevalent clinical manifestation of CVD, occurring in one-quarter to one-third of Western adult populations.2,3 Prevalence figures in Western populations have varied from 10% to 15% when only pronounced or medically significant varices are considered to 30%–50% when all types of disease are included.4,5 A trial of compressions stockings is often considered the initial standard of care for the management of varicose veins and, while effective in controlling edema, healing venous ulcers and reducing their recurrence, the evidence suggests that it has limited efficacy in the management of C2 disease. A wide variety of surgical procedures have evolved over the last century to address the problem of varicose veins. Trendelenburg’s 1890 description of double ligation of
the saphenous vein at the junction of the upper and middle third was followed by Homans’ description of flush ligation of the saphenofemoral junction 1916. Charles Mayo popularized excision of the great saphenous vein (GSV) in the 1890s, such techniques eventually being replaced by a variety of extra- and intra-luminal stripping techniques in the early 20th century. The flexible intraluminal stripper, with direct excision of varicose clusters, was introduced by Myers in 1947 and remained the standard of care through the last half of the 20th century.
Division of Vascular Surgery, Department of Surgery, University of Washington, Seattle, WA, USA Corresponding author: Mark H Meissner, Department of Surgery, Box 356410, University of Washington School of Medicine, 1959 NE Pacific Street, Seattle, Washington 98195, USA. Email: [email protected]
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These treatment paradigms were dramatically altered with the introduction of endovenous thermal ablation techniques (laser and radiofrequency) in the late 1990s. Percutaneous ablation of the GSV, using either radiofrequency or laser energy, has become a widely accepted alternative to stripping. Initial success rates of 95% are standardly reported in association with excellent patient acceptance. Most series have documented less post-operative pain, a more rapid return to work and usual activities, and an objectively improved quality of life early after the procedure. Minimally invasive treatment options have now expanded beyond endovenous thermal ablation and include foam sclerotherapy, mechanicochemical ablation, and cyanoacrylate glue. Unfortunately, both patient and physician acceptance of these minimally invasive procedures has often been driven by early technical reports in the absence of clinical data demonstrating significant early or late benefits in comparison to standard surgical procedures. Early trials are often highly focused, leaving important clinical issues unresolved, and frequently concentrate on short-term surrogate outcome measures.6 Over 90% of new medical devices in the United States are approved through the 510 (k) process, largely requiring demonstration that safety and efficacy are substantially equivalent to a marketed predicate device.7,8 Unfortunately, although this process is effective in encouraging the development of new technology and does provide some mechanism for insuring safety, it often sheds little light on effectiveness with respect to clinically relevant outcome measures.
What are the important determinants of effective vein care To be useful in guiding medical decision making, studies must not only be scientifically sound they must be clinically relevant. Although study methodology is important in determining the quality of evidence supporting any treatment, other important considerations include study limitations (concealed allocation, blinding, loss to follow-up, etc.), consistency of treatment effects, imprecision, and indirectness.9 Indirectness refers to the extent to which features of the study are similar to the question of interest. There are several potential sources of indirectness, including the use of surrogate markers rather than outcomes of importance to the patient and the lack of direct comparisons between two alternative therapies. Direct evidence is the most certain evidence and comes from studies with subjects, treatments, and outcome measures similar to the question of interest. Unfortunately, much venous research continues to rely on indirect evidence, particularly through the use of surrogate outcome
measures. Consideration of appropriate outcome measures is critical to the question of what constitutes effective vein care. Clinically important outcomes measure how a treatment improves a patient’s function, symptoms, quality of life or survival.10 In contrast, surrogate outcome measures are substitutes for outcomes of importance to the patient or health care system. Such measures may include laboratory, radiographic, or other diagnostic tests; physical signs; physiologic parameters; and similar substitutes for important outcome measures.10 Surrogate outcomes often have the advantages of being easier, less costly or less invasive to measure; may require a shorter period of follow-up; and may require smaller samples sizes. However, they must be used and interpreted with caution. Implicit in the use of surrogate measures is that they accurately predict, rather than are simply correlated with, a clinically important outcome.10 Unfortunately, surrogate outcome measures are often based on an unproven, assumed relationship between the surrogate marker and an accepted clinical outcome.11 They may be appropriate in early feasibility studies, in screening the potential of new interventions, and in phase II clinical trials.10,12 However, studies using surrogate outcome should not alter the standard of care. Such studies should serve as the basis for further trials using clinically relevant (or patient important) outcomes. Surrogate outcome measures in chronic venous disease include technical outcomes, such as closure rates, reflux elimination, and hemodynamic improvement as well as clinician-observed outcomes that may or may not be of importance to the patients. Technical outcomes may be important in validating the technical efficacy of a new procedure but are not of primary importance to the patient and cannot alter the standard of care. Such outcomes are particularly attractive in the field of chronic venous disease, where the measurement of clinically relevant outcomes may require years of follow-up. Clinical outcomes are frequently derived from the physician’s observation of the effects of treatment and include elements such as bruising and varicose vein recurrence, and ulcer healing and recurrence. Clinical outcomes can also be captured in validated instruments such as the Venous Clinical Severity Score (VCSS).13,14 Unfortunately, patient’s and physician’s perception of the impact of disease on quality of life is often significantly different. Physicians tend to specifically underestimate the impact of chronic venous disease on patient-reported quality of life.15 Such measures are occasionally appropriate when the captured clinical feature, such as symptomatic varicose vein recurrence, uniformly affects quality of life among patients. However, the importance of many clinical outcomes,
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such as post-operative bruising, differs between patients. Such outcomes further fail to capture the entire burden (physical, psychological, social) of disease and are often poorly correlated with overall quality of life. Quality-of-life instruments directly measure the functional effect of a disease and its treatment on a patient and are probably the most valid outcome measure for chronic diseases.16 Such instruments best measure the impact of the entire burden of disease on the patient. A number of generic and venous diseasespecific quality-of-life instruments17–20 are available. Direct reporting of measures demonstrated to be of importance to the patient, often referred to as a patient reported outcome (PROM), is a critical feature of both types of instrument. Generic instruments are not specific for any disease and can be applied to a range of patient populations. Advantages of the generic instrument include the fact that they allow comparison to both standardized populations and patients with other diseases, they account for the impact of comorbidities on the disease process, and perhaps most importantly, they are sensitive to any adverse effects of treatment. They are, however, relatively insensitive to the effects of disease-specific treatment. In contrast, disease-specific instruments include key features of the index disease and are thus sensitive to the positive effects of treatment. They may, however, be insensitive to adverse treatment effects. Generic and disease-specific instruments are optimally used in combination. Additionally, in times of increasing health care costs and limited resources, the burden of any treatment on the health care system must also be considered. Cost-effectiveness analysis uses improvements in quality-adjusted life years (QALYs) as a universal currency that extends across disease states. Health state valuations are derived from specific generic quality-of-life instruments (EQ-5D, SF6D, HUI) such that one QALY corresponds to one year of perfect health. The impact of treatment on QALYs is then calculated as the product of the years of life remaining and the quality of those years scored from 0 to 1. A cost-utility ratio can then be calculated as the cost to maintain one year of perfect health.
How effective are treatments for chronic venous disease A variety of techniques are available for the treatment of primary saphenous reflux including high ligation and stripping (HL/S), thermal ablation using laser (endovenous laser ablation, EVLA) or radiofrequency energy (radiofrequency ablation, RFA), mechanicochemical ablation, and ultrasound-guided foam sclerotherapy (UGFS). The question of which of these alternatives constitutes the most effective vein care depends
somewhat on perspective. From the patient’s perspective a durable clinical result with the greatest early and late improvement in symptoms and quality of life, least time lost from work and usual activities, lowest risk of recurrence and minimal out-of-pocket costs are important. From a social or payer’s perspective, effective vein care is likely that which provides the greatest improvement in quality of life at the least cost. From this perspective, a less-than-perfect result (some risk of recurrence, some decreased early quality of life) may be acceptable if these issues are easily and inexpensively managed. Good quality evidence does suggest that the interventional management of varicose veins is superior to conservative management with compression stockings. Among 246 patients with extensive varicose veins and GSV reflux randomized to conservative measures or HL/S and phlebectomy in the REACTIV trial,21 significantly greater improvement in symptoms and quality of life was demonstrated in the surgical group. Surgery was judged to be cost-effective with an incremental cost-effectiveness of £1936 per QALY over a 10-year period. Similarly, Sell et al.22 randomized 153 patients to either compression or PIN stripping, phlebectomy, and perforator interruption if appropriate. At two years there was significantly greater improvement in VCSS among those treated with surgery. Health-related quality of life, assessed with the Aberdeen varicose vein score, did not change in the compression group but significantly improved in those undergoing surgery. Given the inferior outcomes, there is little data to support compression stockings alone as the primary management of C2 disease in most patients. With respect to the efficacy of the minimally invasive interventional techniques, several randomized trials have evaluated the surrogate outcome of saphenous vein occlusion or closure. Among 500 patients with C2-C4 disease randomized to EVLA, RFA, UGFS, or HL/S, all done in a clinic setting under tumescent anesthesia, saphenous occlusion rates at one year were significantly lower for UGFS (83.7%, p < 0.001) and equivalent for EVLA (94.2%), RFA (95.2%), and HL/S (95.2%).23 At five years, patency of the GSV was identical among limbs treated with EVLA (17.9%) and HL/S (10.1%, p ¼ .21).24 Several metaanalyses have reached similar conclusions. Among 28 randomized trials variously comparing surgery, RFA, EVLA, and UGFS, only UGSF was associated with a significantly higher risk of primary failure (RR 2.4, 95% CI 1.6–3.6) in comparison to surgery.25 Despite the importance of this data, it is not clear that technical outcomes are highly associated with patient-important outcomes. In a study of proprietary microfoam sclerosant, symptom improvement occurred in both those with and without technical success as
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defined by ultrasound criteria.26 The correlation between technical success and patient-reported symptom improvement using a validated instrument (VVSymQ) was weak (correlation coefficient 0.26). Similarly, in a large registry including 1222 limbs treated with RFA, clinical improvement was noted in in 70%–80% of the 185 limbs with anatomic failure at five years and only 10.3% of these limbs required reintervention.27 Additionally, recurrent reflux in the GSV24 and clinical recurrence of varicose veins have not been clearly related to technical failure.28 Finally, there is no clear relationship between GSV occlusion and either the VCSS or quality of life at five years. Although unrelated to long-term outcomes, postoperative pain scores have also been used to support the efficacy of one treatment modality in comparison to another. RFA (mean 10-point visual analog pain score 1.21 1.72) and UGFS (1.60 2.04) are associated with lower pain scores over the first 10 days after the procedure than EVLA (2.58 2.41) or HL/S (2.25 2.23).23 Although the clinical relevance of these small differences in pains cores is unclear, patients undergoing RFA or USGFS did return to normal activities 1 to 3 days earlier than those undergoing EVLA or stripping. A meta-analysis of 21 randomized clinical trials similarly suggested less early postoperative pain among patients undergoing either EVLA (median difference –0.6, –1.1 to –0.2) or RFA (–1.6, –2.1 to –1.1) in comparison to surgery.25 In comparison to surgery, return to work and usual activities was also significantly shorter among patients undergoing RFA, but not EVLA. However, as varicose veins are a chronic disease, transient conditions such as post-operative pain are relevant only if long-term improvements in patient-important outcomes are at least equivalent to the comparative therapy. Similarly, most post-operative complications are rare and transient, impacting the efficacy of varicose vein care only if they reduce long-term quality of life. However, as for post-operative pain, they may be important considerations if the efficacy of two modalities is otherwise equivalent and the endovenous techniques do appear to be associated with fewer complications than HL/S. In a meta-analysis of 19 studies, endovenous thermal ablation was associated with 70% and 50%–60% relative risk reductions in the incidence of infection and hematoma in comparison to surgery.25 There was no difference in the incidence of paresthesias, although RFA was associated with a 2.3 (1.1–5.0) higher risk of superficial thrombophlebitis that was not seen with EVLA. Late complications including persistent dysesthesias and hyperpigmentation are also rare and occur with similar frequency with EVLA and HL/S.29 Recurrence is a well-recognized risk of superficial venous procedures and approximately 15%–20% of
all varicose vein procedures are done for recurrence.28 Rates of recurrence have been reported to be up to 33% at two years and as high as 41% and 70% at 5 and 10 years, respectively.30 Patients’ report concerns regarding recurrence as being among the most important factors in choosing among treatment modalities.31 Furthermore, as early recurrence of varicose veins (within one year) is associated with significant reductions in quality of life and overall satisfaction with the procedure, it is a patient-important outcome.28 The rates of recurrence between the various modes of treating saphenous incompetence do not seem to be substantially different. Although UGFS is associated with significantly higher rates of saphenous patency at one year (16.3%), no differences in recurrent varicose veins have been demonstrated between EVLA (11.6%), RFA (7.3%), UGFS (13.8%), and HL/S (14.8%).23 Similarly, recurrent varicose veins were noted in 46.6% and 54.6% of patients five years after EVLA or stripping respectively (p ¼ .72) and resulted in reoperation in 38.6% and 37.7% of limbs (p ¼ .99).24 A second randomized trial reported equivalent rates of clinical recurrence among those undergoing EVLA (54%) and HL/S (45%, p ¼ .15) at five years follow-up. Although most recurrences required no intervention, additional procedures were significantly more common in those treated with EVLA (51% of recurrences treated) in comparison to HL/S (33%, p ¼ .04). A systematic review and meta-analysis has also suggested no significant difference in the risk of recurrence between EVLA (RR 0.6, 0.3–1.1) or RFA (RR0.9, 0.6– 1.4) and surgery.25 However, despite these largely consistent results, at least one randomized trial28 and two network meta-analyses30,32 have suggested lower recurrence rates in patients undergoing thermal ablation. Among 280 patients randomized to EVLA or HL/S, recurrence was significantly more frequent in patients undergoing HL/S (20.4%) in comparison to EVLA (4.0%, p < .001).28 At least part of this difference was likely related to stripping just below the knee versus EVLA to the most distal point of reflux, the majority of recurrences occurring in the below-knee GSV in the stripping group. Additionally, there was no difference in the number or type of additional procedures performed for recurrence after HL/S or EVLA. A network meta-analysis of eight studies suggested UGFS to have the highest probability of recurrence, HL/S an intermediate probability, and EVLA the lowest probability.32 A second, larger meta-analysis including 23 trials reported similar results – a trend toward higher rates of recurrence after USGFS followed sequentially by RFA and EVLA.30 Although rates of recurrence are similar, the patterns of recurrence are somewhat different for stripping and
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the endovenous thermal techniques. Recurrences related to a previously treated GSV (same site recurrence) are more common after EVLA than HL/S.29 Groin recurrences, related to neovascularization, are much more common in patients undergoing HL/S and account for almost half of clinical recurrences in some28 but not all29 trials. Recurrence associated with thigh perforators also appears to be more frequently associated with HL/S.24,28 Groin recurrences after thermal ablation are largely related to disease progression and new anterior accessory saphenous vein (AASV) reflux. Merchant et al.27 described three patterns of anatomic groin recurrence five years after RFA – initial, persistent non-occlusion of the GSV; recanalization of an initially occluded GSV; and reflux in a groin tributary, usually an accessory saphenous vein. Although recanalization and new groin reflux were associated with a three- to four-fold increased risk of recurrent varicosities, initial failure was not. As discussed above, patient-reported quality-of-life outcomes best account for the impact of all aspects of a chronic disease on the patient. In a randomized trial, Rasmussen et al.23 found that patients undergoing EVLA or stripping had more pain and discomfort at three days than those treated with UGFS or RFA. However, all modalities resulted in equivalent improvement in quality of life from one month through one year. Similarly, no differences were found in diseasespecific (Aberdeen Varicose Vein Severity Score) or generic (SF-36) quality of life five years after EVLA or stripping.24 A second large randomized trial29 also found no difference in disease-specific quality of life, measured by the CIVIQ-2 instrument, between EVLA and stripping at five years. Finally, a meta-analysis including six studies comparing EVLA and surgery also found no significant differences in quality of life measured by the AVVSS at 2 to 24 months.25 As all of the treatment modalities – EVLA, RFA, UGFS and HL/S – result in similar long-term improvements in quality of life, the most effective procedure may ultimately be that which is least expensive. Although the data suggest a higher risk of primary technical failure with UGFS, the lower cost, safety, and repeatability will undoubtedly favor its use in some situations. Rasmussen et al.23 found that when only procedure-related costs were considered, RFA was the most and USGS the least expensive option. When the cost of lost work was included, EVLA and HL/S became the most expensive while UGFS remained the least expensive. However, in a network meta-analysis, both surgery and thermal ablation resulted in more QALYs than UGFS.32 Over a fiveyear time horizon, which included initial treatment, any early retreatment, and recurrence, thermal ablation cost an additional £151 in comparison to UGFS.
However, with an incremental cost effectiveness ratio (£3161 per QALY gained) well below the UK willingness to pay threshold, thermal ablation was judged to be the most cost-effective treatment strategy. It must be noted, however, that the probability of UGFS being cost-effective increases as the willingness to pay threshold falls and may exceed that of thermal ablation at values below £10,000 per QALY gained. In contrast, a second meta-analysis found that, because differences in QALYs between the various treatments were quite small, cost-effectiveness was driven primarily by cost differences between modalities.30 Although there is considerable uncertainty surrounding the cost of treatment, UGFS was judged to be most cost effective.
Adjuncts to effective vein care Although the management of truncal venous incompetence remains a cornerstone in the management of superficial venous disease, several adjuncts, supported by variable amounts of evidence, have been incorporated into modern treatment strategies. These include the concurrent or staged management of tributary varicosities, routine post-procedural compression, and early post-operative ultrasound surveillance. As all of these adjuncts have implications for patient comfort, quality of life, and convenience, they are an important consideration in effective vein care. Concurrent versus staged management of varicose tributaries continues to be controversial. Treatment of tributaries with phlebectomy or sclerotherapy at the same time axial reflux is treated may lead to overtreatment and, indeed, among 54 limbs followed for six months after RFA of the GSV, 28.4% of varices resolved and 41% of limbs required no further treatment.33 However, staged tributary management may also require secondary procedures with associated patient inconvenience, reduced quality of life, and increased societal costs related to time lost from work and usual activities. Most patients (71%) do desire treatment in a single visit.31 The results of small randomized trials have been conflicting, but a meta-analysis of four comparative studies evaluating the timing of tributary intervention showed a non-significant trend towards fewer procedures among those undergoing simultaneous tributary intervention (Odds ratio 0.734, p ¼ 0.339), although heterogeneity was very high (I2 81%).34 Disease-specific quality of life was, however, significantly improved at 6 weeks, but not at 12 weeks, in those undergoing simultaneous treatment. Although confounded by the variable use of general anesthesia, there does not appear to be any difference in venous thrombotic complications between the two strategies. The advent of thermal ablation techniques moved duplex ultrasound from a primary diagnostic modality
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to a vital therapeutic adjunct to the procedure. As it was incorporated into the procedure, it is not surprising that early results were often routinely evaluated using ultrasound. The importance of ultrasound follow-up was further supported by early reports of saphenofemoral thrombus extension (Endothermal Heat Induced Thrombosis, EHIT) in as many as 16% of patients.35 This ultimately led to several classification schemes for such thrombus extensions.36 However, rates of thrombotic complications have progressively fallen as experience with these techniques has accumulated,34 such that recent literature suggests rates of DVT, PE, and EHIT in as low as 0.2%, 0.1%, and 0.5–0.8%, respectively.37 Most of these thrombi are small, asymptomatic, and resolve relatively rapidly, suggesting that they represent direct extension from an area of injury rather than true systemic activation of coagulation. Data from trials of proprietary microfoam26 further suggests that many of these thrombi have a relatively benign prognosis regardless of treatment. Finally, routine screening for and subsequent treatment of these thrombi often fails to account for the potential harms of therapy including patient inconvenience and rare bleeding complications. The often accepted policy of routine ultrasound screening after endovenous procedures may contribute little to the effectiveness of vein care and needs further critical evaluation. Post-procedural compression is often routinely prescribed after treatment of superficial venous insufficiency. Although compression may be theoretically valuable in improving technical outcomes; reducing morbidity due to ecchymosis, pigmentation, and deep venous thrombosis; and reducing post-operative pain, this is supported by little data. Among 104 patients undergoing inversion stripping and randomized to compression bandages for three days or compression bandages followed by stockings for four weeks, there was no significant difference between groups in visual analog pain scores at two or four weeks.38 Among 93 patients randomized to compression stockings for 48 hours or seven days after EVLA, there was no difference in saphenous closure rates, although visual analog pain scores were significantly lower at one week, but not at six weeks, in those randomized to stockings for seven days.39 As there do not seem to be substantial differences in technical outcomes with the routine use of post-procedural compression, it may be reasonable to discuss the potential benefits of reduced postoperative pain versus the inconvenience of wearing stockings with the patient.
dramatically changed the clinical management of varicose veins. Early adoption of these techniques has been largely driven by physician and patient preferences based on surrogate technical outcomes that often correlate poorly with patient important outcomes. Fortunately, although it remains incomplete, data regarding the more important benefits of these procedures is accumulating. The most effective treatments for C2 disease are those that provide the most patient-important benefits including minimal post-operative discomfort, rapid return to usual activities, a low rate of recurrence, and the greatest long-term gain in quality of life. The available data suggest that all of the minimally invasive procedures, including EVLA, RFA, and UGFS, are clinically effective alternatives to HL/S. Although differences in QALYs between the procedures are small, they do marginally favor the less invasive modalities over surgery. The technical results of UGFS are inferior to those of the thermal techniques, but it does have the advantage of being minimally invasive, inexpensive, and well-tolerated. Although retreatment is associated with patient inconvenience and procedural discomfort, overall payer costs are more closely related to the initial cost rather than those of retreatment.30 When analyzed from the payer’s perspective, UGFS is likely the most cost-effective treatment option. However, there is substantial uncertainty surrounding these figures, leading some30 to conclude that other factors of importance to the patient may outweigh cost alone.30 With regards to adjuncts to the treatment of truncal varicosities, there is little definitive evidence supporting simultaneous versus delayed management of tributaries with sclerotherapy or phlebectomy. Simultaneous tributary intervention is preferred by patients and is associated with early, but not sustained, improvements in quality of life. The incidence of thrombotic complications has progressively decreased as experience with endovenous ablation has increased and the value of early routine postoperative screening, particularly when balanced against the inconvenience and potential harms, should certainly be questioned. Although the use of post-operative compression stockings beyond two days may improve early patient discomfort, it has no impact on technical success and the choice to continue compression should likely be left to a well-informed patient. 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.
Summary
Funding
The introduction of minimally invasive techniques for the management of axial superficial reflux has
The author(s) received no financial support for the research, authorship, and/or publication of this article.
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