Abstract
Varicose veins are an extremely common condition causing morbidity; however, with current financial pressures, treatment of such benign diseases is controversial. Many procedures allow the treatment of varicose veins with minimal cost and extensive literature supporting differing approaches. Here we explore the underlying evidence base for treatment options, the effect on clinical outcome and the cost-benefit economics associated with varicose vein treatment. The method of defining clinical outcome with quality-of-life assessment tools is also investigated to explain concepts of treatment success beyond abolition of reflux.
Background
With the onset of the global economic crisis and the threat of world recession, health economics has become increasingly important in healthcare decision-making. Discussions on the health economic benefits or burdens of new endovascular techniques are common.
healthcare costs are spiralling; in the UK they have doubled over the last decade to £126 billion annually, 1 and a similar picture is seen in the USA with spending now at $1.2 trillion/year, 2 equivalent to over 8% GDP, a value seen throughout Europe as well. 3 In the National Health Service (NHS), austerity measures require a saving of £20 billion on this budget of £126 billion (16%), whilst caring for an ever more elderly and frail population. 4
Although costs and value for money have always had a role in the decision-making processes, these increasing financial pressures at the hospital, regional and national level have caused hospital managers to look at ways to cut costs at all levels. Varicose veins have been labelled as a ‘Procedure of Low Clinical Value’ due to the low mortality rates associated with this benign disease, leading to a reduced rate of referral for treatment.5,6
With the majority of patients with varicose veins being young and otherwise systemically well and with varicose veins rarely having a significant effect on mortality, they are afforded low priority. Therefore, by reporting crude outcomes through serious morbidity (or complications) and mortality, the object of treatment is missed and it allows questions to be raised over the necessity for intervention. In benign diseases quality-of-life (QOL) assessments are invaluable in revealing the true clinical benefit of intervention.7,8
Varicose veins are extremely common (approx. 25% of the population), 9 and so even moderate improvements in patient outcome generate large overall population improvements. 10
QOL assessment
QOL instruments include both generic and disease-specific surveys. Generic surveys assess global states of wellbeing and provide a subjective measure of treatment efficacy, while disease-specific surveys focus on elements associated with particular disease processes and treatment effects. 11 14
In the UK, the National Institute for Health and Clinical Excellence (NICE) was founded in 1999. NICE is an independent government-funded organization that advises the National Health Service and has become a role model for the development of clinical guidelines and attempts to evaluate the cost and cost-effectiveness of potential new treatments and technologies within the NHS. It has set a cost-effectiveness threshold of £20–£30,000 per QALY (quality-adjusted life year) gain for appraisal of surgical procedures.
Vascular surgery is a specialty where there has been an ever-expanding introduction of new and often expensive technologies, some of which have not been fully evaluated.
Varicose veins
Varicose veins affect approximately 25–50% of the adult population, 15 and complications arising from them are a significant cause of patient morbidity and health service expense. 16
Symptoms are often vague and non-specific but include aching, discomfort, pruritus and muscle cramps; however, there are more obvious and objective symptoms which include varicose eczema, pigmentation, bleeding and ulceration. 17 Extensive previous work has shown that venous disease significantly impairs QOL. 18 20
There are widespread misconceptions held by both the general public and primary care physicians with regard to varicose veins. The public fear that there is an increased likelihood of deep vein thrombosis (DVT) and that chronic venous changes are a common cause of limb amputation. However, primary care physicians are often mistaken in believing varicose veins are merely a cosmetic concern and even the skin changes of chronic venous insufficiency (a precursor to ulceration) are inconsequential. Extensive evidence exists to show the outcome of treatment of venous disease, but this requires the use of QOL measures. All forms of venous treatment have been shown to improve QOL.10,21-26
Varicose vein assessment
CEAP classification
Varicose veins have often been inadequately defined and have variously been described as being visible subcutaneous veins, to dilated palpable subcutaneous veins generally larger than 3 mm in the upright position. Due to this lack of consensus in the reporting and classification in the published literature, the CEAP (Clinical severity, AEtiology, Anatomy, Pathophysiology) classification for chronic venous disorders was developed in 1994 by an international ad hoc committee of the American Venous Forum, endorsed by the Society for Vascular Surgery, and this classification became incorporated into ‘Reporting Standards in Venous Disease’ in 1995, with further refinements made to it in 2004. 27 This classification has been ubiquitously adopted and so allows more a direct comparison between studied modalities.
This is a clinician-implemented categorization tool. The clinical component indicates disease severity, ranging from zero points, for completely asymptomatic patients, up to six points for active ulcers. The aetiological component denotes the venous disease as congenital, primary or secondary in nature. The anatomic classification pinpoints the veins involved as superficial, deep or perforating. The pathophysiological classification identifies the presence of reflux in the superficial, communicating, or deep systems, as well as the existence of outflow obstruction. The CEAP classification is doctor driven, and highlights the cause of the underlying venous abnormality; however, it is not sensitive enough to track progressive changes.
Venous clinical severity score
The venous clinical severity score (VCSS) is a clinician-completed tool, which includes nine hallmarks of venous disease, each scored on a severity scale from 0 to 3. In order to generate a dynamic score, VCSS categories are scored individually. These include skin changes and pigmentation, inflammation and induration, and ulcers (including number, size and duration). In 2007, an international ad hoc working group was created to revise the VCSS to update the terminology, simplify the application and clarify ambiguities, which was completed in 2010. 28
The value of the VCSS is its ease of use along with an emphasis on the most severe manifestations of venous disease which are likely to show the greatest response to therapy allowing tracking and quantification of improvement (or deterioration).
Aberdeen varicose vein questionnaire
The Aberdeen varicose vein questionnaire is a 13-question patient-completed survey addressing multiple elements of varicose vein disease, first developed in 1993. 29 It has subsequently been translated into many languages.
Physical symptoms along with social issues, including pain, ankle oedema, ulcers, compression therapy use and limitations on daily activities are examined, as well as the cosmetic effect of varicose veins. The questionnaire is scored from 0 (no effect) to 100 (severe effect).
Short form health survey (SF-36, SF-12, SF-8)
A widely used and well-validated generic health QOL assessment tool is the short form health survey (QualityMetric, Lincoln, RI, USA), developed over time with questions in physical and mental health. These two categories have been broken down into eight domains that include physical and social functioning, role limitations due to physical or emotional problems, mental health, pain, vitality and health perception. The survey generates a score ranging from 0 to 100, with higher scores indicating better general health perception.
EuroQOL 5 domain
The EuroQOL 5 domain survey (Euroqol, Rotterdam, The Netherlands) is an alternative validated patient completed generic health QOL questionnaire that measures mobility, self-care, usual activities, pain and anxiety domains. The domains generate a unique QOL outcome between –0.594 and 1 with 1 being perfect health.
It also provides a separate visual analogue scale rendering of global health status, from 0 to 100, with higher scores indicating better health.
Treatment of varicose veins
The treatment of patients with superficial venous reflux has changed in recent years following the widespread acceptance of minimally invasive, endovenous modalities including ultrasound-guided foam sclerotherapy (UGFS), radiofrequency ablation (RFA) and endovenous laser ablation (EVLA).30,31 All interventions are aimed at principally abolishing truncal reflux and then removing or occluding any incompetent varicosities.
Postal surveys carried out in 2008 and 2009 revealed that most surgeons who performed varicose vein surgery still regularly performed traditional open surgery, but over one-third also offered minimal access techniques either instead of open surgery, or as an adjunct procedure.32,33 In the UK, an average of 40,000 NHS-funded interventional procedures are completed each year. 34
Compression
Compression stockings may be employed as a primary treatment for patients with symptomatic varicose veins. They act by providing graduated radial pressure between ankle and knee/thigh, and this along with the calf muscle pump returns venous blood cranially Stockings are extremely attractive for the cost-conscious initially; however, the need for replacements (4 times per year) and poor compliance greatly reduce their effectiveness. 35 Additionally some patients (37%) still complain of persistent venous symptoms despite stockings. 36
Conventional surgery
Standard surgery for varicose veins was first described over 100 years ago, and is still considered the gold standard against which other treatment modalities are tested. The results of surgery are good and patients are generally satisfied. Surgery is associated with an improvement in QOL in most patients. However, there is a significant rate of minor complications. 37 Rates of morbidity vary from series to series.21,22,38
New techniques that have arisen interrupt the reflux haemodynamics while preserving the long saphenous vein and include the ASVAL and CHIVA techniques.39,40 These provide minimally invasive treatments performed under tumescent local anaesthesia, and have produced good results. One single-centre series has shown that while CHIVA offers improved recurrence rates compared with open stripping in experienced hands, it has a steep learning curve and can lead to worse outcomes. 41
Endovenous ablation
In the last decade the introduction of minimally invasive endovenous ablation therapy has revolutionized the treatment of varicose veins. 30
Three endovenous modalities offer thermal ablation – RFA, EVLA and steam (SVS). RFA and EVLA have 10 years of evidential data, though with rapid advances in technology many series have now been superseded.
Current RFA technology includes the VNUS ClosureFAST catheter and the Olympus CELON RFITT catheter. These offer effective reproducible treatments under local anaesthetic in the outpatient setting.30,42 Direct comparisons with laser ablation have shown an equivalent efficacy with a reduced side-effect profile.22,24,43
Laser treatment has expanded from the original 810 nm wavelength laser to a wealth of different wavelengths, with different treatment profiles.30,31 These different wavelengths offer a flexibility of treatment not found in other endovenous modalities.44,45
Steam is a new technology of thermal ablation, with only limited evidence of proof of concept at present. 46 Puffs of steam provide the energy for thermal denaturing of the long saphenous vein.
New developments include Clarivein mechanochemical ablation and Sapheon cyanoacrylate glue closure. Clarivein has shown encouraging early results of 96.7% closure at six months. 47 This technique of mechanical scarifying of the vein and instillation of liquid sclerotherapy needs no tumescent and so offers a less invasive alternative to thermal ablation. A further option is the Sapheon Venaseal Closure System, which utilizes proprietary glue to seal the vein; however, this has only been described at conference presentations so far.
Ultrasound-guided foam sclerotherapy
UGFS is an effective and cheap method of chemically ablating incompetent varicosities. It is truly minimally invasive, requiring only a single needle puncture and no catheterization 48 and has been shown to be more effective than conservative therapy with compression. 49 The literature on foam sclerotherapy is extensive and it can provide similar closure rates and significant improvements in QOL outcomes at one year.22,50 It appears to be more user-dependent than other modalities, though in experienced hands can provide excellent treatment at an unbeatable price. 51 Recurrence, however, can be a problem in some series. 52
Cost-effectiveness
Despite being one of the most commonly performed surgical procedures, very few cost-effectiveness evaluations have been calculated. Ratcliffe et al. 53 conducted a randomized trial comparing open surgery with conservative management.
The surgical group was a heterogeneous collection of unilateral and bilateral procedures performed under general anaesthesia as a day case, and the conservative group was treated with compression hosiery or bandaging. Not only did they demonstrate that open surgery was cost-effective using £20,000 QALY level, but a third of patients allocated to the conservative group dropped out to undergo surgery before the trial had finished.
The main aim of the REACTIV (Randomized and Economic Assessment of Conservative and Therapeutic Interventions for Varicose Veins) study was to investigate the clinical and cost-effectiveness of varicose vein treatments. 54 Patients were split into three groups:
– minor below knee varicose veins without truncal reflux, randomized to conservative or sclerotherapy treatment, n = 34;
– moderate below knee varicose veins with truncal reflux, randomized to standard surgery or sclerotherapy treatment, n = 77;
– significant varicose veins above and below the knee with truncal reflux, randomized to conservative treatment or standard surgery, n = 246.
Once again, a significant number of patients allocated to a conservative management path became dissatisfied and dropped out of the study so that they could undergo surgery. Although numbers were small in some groups, this study demonstrated the economic value in treating patients with symptomatic varicose veins.
Subramonia and Lees performed a study comparing surgery and RFA 55 which incorporated cost analysis into the design. 56 This study randomized 88 patients into RFA (VNUS ClosurePlus™) and conventional surgery (RFA 47, surgery 41) under general anaesthetic. RFA was found to be significantly more expensive (£1276 versus £559); however, the RFA group returned to work an average of one week earlier (10 days versus 18.5 days), at a cost of £6.14 per additional working hour gained. However, this study utilized the VNUS ClosurePlus™ catheter, which is six times slower than the current VNUS ClosureFAST™ catheter (0.05 cm/second versus 0.33 cm/second). The cost difference was due to increased theatre time (83.6 minutes versus 55.7 minutes, additional cost £171.01) and catheter cost (£550).
Gohel et al. 57 produced a Markov model to evaluate the cost-effectiveness of traditional and endovenous treatments for patients with primary great saphenous varicose veins. Day-case surgery or endovenous ablation using EVLA or RFA performed as an outpatient were shown to be the most likely cost-effective treatment strategies for patients with primary unilateral great saphenous vein reflux requiring treatment. However day-case traditional surgery was also shown to be below the conventional threshold of the cost-per-QALY in the UK and therefore cost-effective.
Recent work by Rasmussen et al. 22 showed equivalence between all available modalities, in a direct comparison trial of 580 legs. All procedures were under local anaesthetic and treatment time was 19–32 minutes. RFA was shown to be associated with less postoperative pain leading to a faster return to work and therefore a better cost-effectiveness analysis compared with open surgery or laser ablation. Catheter costs were EVLA £307 and RFA £371. Foam sclerotherapy remained the cheapest option, but was associated with a significantly higher recurrence rate at one year (16% versus 5–6%). 22
With a wide range of available treatments and few comparative studies, treatment choices are currently made on the basis of local availability and clinician preference, rather than clinical evidence. All procedures have been shown to be effective at both abolishing reflux and improving QOL.22,24,52,55,58,59 Additionally, day-case surgery, RFA, EVLA and UGFS have been demonstrated to be cost-effective at the limit of £20,000 per QALY. 57
Patient preference
With the evolution of a patient-centred model of health care, the preferences of the patient must be one of the major contributors to the treatment plan. Varicose veins have many options and these should all be offered to patients with appropriate guidance before a definitive plan is agreed. Recent studies show that while patients felt unable to access modalities formally, they had significant preferences for local anaesthetic and one sitting treatment, 60 though expectations need to managed prospectively to avoid patient disappointment. 61
Conclusion
Varicose veins have a multitude of treatment options, all of which provide excellent improvements in QOL at a cost-effective level. Overall costs have fallen dramatically despite material requirements, and no patient should be without a treatment option. The treatment of varicose veins is one of the few treatments that offer low morbidity for large improvements in QOL. Importantly, despite the higher incidence of varicose veins in older patients, a high percentage of patients are of working age when health improvements are most cost-effective.