It is my opinion that while phlebologists are often quite certain about preferred treatment modalities, there is a general lack of awareness and understanding about the varicose vein problem which is necessary to elicit from the patient the true impact of their venous disease and thus their preferred treatment. A phlebologist may well be thinking in terms of his preferred treatment, but is it the right one for the patient? Coming from this angle and looking at the burden of disease and patient preference in treatment, I am drawn into areas of medical research which may well conflict with my own previous opinions and those of my surgical mentors, but in an academic context which demands an open-minded assessment of evidence and informed opinion, it is vital that I play the devil’s advocate.
The surgical standpoint is perhaps the traditional viewpoint and one which the vascular surgeon zealously guards, but the more recent explosion in minimally invasive techniques has dramatically shifted the balance of power more into the hands of the phlebologists. It is not my intention to cause offense to my surgical colleagues but rather to state throughout this essay that the best treatment for varicose veins may well lie in techniques which the surgeon considers his own, as a surgical technique does not discriminate between the hands of a vascular surgeon or a phlebologist.
Overview of Varicose Veins
aphenous ablation may be by surgery or more recently the less invasive endovenous techniques. This is an effective treatment in abolishing venous reflux in the saphenous vein, but the aim is to relieve symptoms and improve quality of life rather than to prevent more severe venous disease. Conservative management involves elastic compression, leg exercise, and regular assessment. These treatments are effective for symptoms and healing of skin changes, but prevention of progression of disease is their weak point. The decision between these two very different treatment options is an important one, and applying collective patient values and preferences will aid the physician and patient in reaching a decision which is acceptable to the patient.
Varicose veins are very common, affecting men and women, and occurring in up to 30% of the adult population. The cause is usually due to venous reflux or valve failure, which leads to the pooling of blood in the leg veins. This, in turn, causes vein dilation and a cluster of symptoms which may progress to more severe skin changes or ulceration. Such skin changes are a sign of severe underlying venous disease, and if not treated, the ulceration rate can be as high as 4% in the older population. The best diagnosis for varicose veins and associated venous disease is usually by a specialist venous medical service. Duplex ultrasound is the best investigation as it is both anatomic and hemodynamic, but a very experienced clinician may get a good idea of the severity of venous disease by history and clinical examination.
Importance of Patient Preferences in Treatment Decisions
Given the nature of the conditions that were previously mentioned, varicose veins and venous ulcers are often painful and at times debilitating. But despite strong medical advice, the decision to treat these conditions is often postponed. There are scenarios when earlier assessments for a particular treatment would have come out differently had the information been given to the patient at that time. An example is a case where a physician explains the objective benefits of a surgery he feels is best, but while considering an older patient’s mild symptoms, the same surgery may not actually be ideal for than a more conservative treatment. A patient with CVI had undergone such a scenario. Due to a lack of patient involvement in decision making, his treatment caused a significant amount of regret and his health was negatively affected. This illustrates a situation where the patient may not fully understand the values and the drawbacks of the available treatments. By assessing the patient’s values and what they hope to achieve from treatment, both the patient and physician may more effectively weigh the pros and cons of potential treatments and make a more informed decision.
In making medical decisions, patient preferences play a deciding role. What the patient feels is best for their health is the path most likely to be taken. This is why it is important to assess the patient’s views and values when deciding on a particular course of treatment, especially when the objective and subjective results of the treatment vary significantly. have noted the importance of patient preferences in making decisions for a subset of conditions known as “preference-sensitive conditions.” They found, after analyzing 40 studies, that there was a significant effect in 75% of comparisons on preferences when a decision was made for a preference-sensitive condition. Another thing they noted from the data is that patients’ decision-making may vary depending on their state of health. The effect of severe symptoms on patients was shown recently by the AVVQ, which is a health-related quality of life survey for patients with varicose veins and/or venous ulcers. reported results that show that differences in state of health can significantly alter the patients’ perceived value of their vein treatment. This highlights the importance of multiple assessments of patient preferences in deciding between various treatment options.
Non-Surgical Treatment Options
Sclerotherapy was first used to treat varicose veins in the early 20th century. It remains a treatment option in the 21st century, although it is less commonly used than it was in the past. This is partly because newer treatments have been developed, and also because the long-term effectiveness of sclerotherapy for larger veins is not as good as for the newer techniques. During sclerotherapy, a solution is injected into the veins, causing them to clot and the vessel to scar and fade from view. The procedure may cause discomfort, slight pain, swelling, skin color changes, and an ulcer at the injection site. There is also a very high recurrence rate with this treatment. Despite this, many GPs will still recommend sclerotherapy for larger varicose veins, although it is often referred for treatment in the private sector.
Changes to lifestyle, particularly weight loss, leg exercises, and not standing still for prolonged periods, can prevent varicose veins from getting worse. Those with a predisposition to varicose veins from family history should protect their legs from a young age. This may prevent or delay the onset of varicose veins in people who are at risk of developing them. In our aging population, this will be beneficial in reducing healthcare costs and improving the quality of life for many people. For people with mild symptoms or few varicose veins, these self-help measures may be the only treatment required.
Compression stockings are the mainstay of conservative management. Sufferers with varicose veins are generally symptomatic, in particular they are more likely to have an itching rash and ankle swelling. Elastic compression can improve these symptoms. Compression acts by counterbalancing the raised venous pressure, thereby reducing venous distension.
Compression Stockings
Before getting into a discussion about compression therapy, it is important to first clarify our understanding of compression stockings. This is the most often due to lack of physician or healthcare professional direction in purchasing and using compression stockings. Most medical providers self-explanatory, but many patients and provider are often confused about what type of compression stockings to buy and how they should be used. In a comprehensive review of the use of compression therapy for chronic venous insufficiency, Kakkos et al. indicated that they did not have a firm understanding of the level of compression in 42% of cases and that in 70% of cases they were unclear about the duration of use required. This highlights the fact that when patients are simply told to go out and buy some compression stockings or hose by their physician, there is often lack of adherence to wearing them and a poor understanding of the need for long term use or specific indications. If patient compliance and understanding is so low when compression therapy is universally accepted and recommended, it is understandable that these treatments may be less popular when there are alternative options.
Some of patients’ main concerns about chronic venous disease in the lower extremities revolve around the necessity of surgery. Although varicose vein surgery has changed dramatically over the past decade, developing into minimally invasive techniques such as endovenous ablation or ambulatory phlebectomy, many patients are hesitant to undergo any surgical procedure due to fear of pain, cost, time away from work and family, or the potential for adverse events. Also, some medical providers who refer patients to vascular specialists are hesitant to do so, thinking that the only treatment option available for their patients is surgery. Therefore, understanding and education about the full spectrum of treatment options available for varicose veins is vital for both patients and medical providers.
Lifestyle Changes
Essential for all patients with varicose veins, the implementation of a healthy lifestyle is one of the most important parts of the conservative management of veins. Bringing about lifestyle changes can often prevent the need for further treatment of varicose veins or at least slow down its progression. Weight reduction will reduce the incidence of venous reflux and progression of varicose veins. This is due to the increase in intra-abdominal pressure caused by being overweight or obese. The elevated pressure is transmitted down the deep veins and into the perforator veins causing venous reflux, which in turn causes the varicose veins to enlarge. Reflux usually occurs at the saphenofemoral or saphenopopliteal junctions and if left untreated will cause more severe skin changes and if provoked may cause an episode of superficial vein thrombophlebitis. This is an inflammatory condition with associated symptoms of pain, swelling, and redness in the affected limb. Weight reduction can result in the saphenofemoral reflux improving or even resolving. A Review of the treatment of varicose veins with regard to weight reduction or increased exercise suggested that this treatment be taken into account but further evidence was required to fully assess its success. However, it is common sense that increased exercise and weight reduction are beneficial to a patient’s general health and the associations between varicose veins and the above factors are well documented.
Sclerotherapy
Sclerotherapy is a non-surgical procedure that can be carried out in your doctor’s office to treat uncomplicated small varicose veins and spider veins. Usually, more than one injection is needed and the injections are done every 6-8 weeks. The veins are injected with a solution (sclerosant) that causes them to collapse and fade. The procedure may also remedy the bothersome symptoms associated with spider veins, including aching, burning, swelling, and night cramps. Because the needle used is so small, patients usually do not require any form of anesthetic, and usually no bandages or dressings are required. Some form of compression is usually recommended for a few days to encourage the veins to remain closed. The procedure time is usually less than 30 minutes. Patients who have had this procedure performed have been very pleased with the results. They find no unsightly bandages or scars are needed, and the fact that no time off work is required is an important consideration. If time is taken off, it is usually only for the time taken to have the procedure performed. Other forms of treatment have had high satisfaction levels mainly due to the improvement in symptoms and the improved cosmetic look of the legs.
Surgical Treatment Options
Both laser and radiofrequency ablation have been compared with stripping operations in RCTs. These studies typically have involved patients with more advanced CEAP clinical classes C2 through C4 and have excluded those with the more severe C5 and C6 classes that are often associated with significant skin changes and healed or active venous ulcers. Most comparisons have involved treatment of only the great saphenous vein, although some patients may have had concurrent vein stripping or treatment of the small saphenous vein or other truncal veins. Measures of treatment efficacy have varied among studies. Some have used more objective anatomic endpoints such as venous reflux detected by duplex ultrasonography or recanalization of the treated vein segment. Subjective directed quality of life instruments and generic quality of life instruments often have been used as well. Measures of symptom improvement have varied, with some studies focusing on global improvement and others looking individually at different symptoms. Randomized study results and other data comparing endovenous ablation to stripping were recently reviewed by an expert panel, who used the Delphi consensus method to make recommendations for clinical practice.
Endovenous ablative procedures include any technique in which a catheter is placed within the lumen of the abnormal vein under ultrasound guidance to deliver energy inside the vein, resulting in heat-induced closure of the vein. The most commonly used methods are laser ablation and radiofrequency ablation. These procedures are usually performed in an office-based setting under local anesthesia. The patient begins walking immediately after the procedure, and normal daily activity is encouraged. Pain, if any, is usually minimal. The energy source and its specific application to the vein vary with each technique, but all have a common mechanism of causing thermal damage within the vein leading to fibrosis and closure. The patient is usually fitted with a compression stocking that is worn for a variable period of time, usually depending on the length of time the patient has had symptoms and the degree of truncal venous reflux.
Endovenous Ablation
The next great development in the treatment of venous pathology, endovenous ablation, is quickly becoming the gold standard for dealing with saphenous varicose veins. Newer treatments like EVLT have sparked a point of controversy amongst vascular specialists, as to when this treatment should be used. The first key point is that the long-term effects of these newer treatments are not yet known, and as such one must compare their results with the current gold standard of surgical intervention, being vein ligation and stripping. EVLT and other such treatments have shown to be very effective in dealing with symptoms and improving the visible signs of varicose veins, often with less postoperative pain and a quicker return to normal activity. This is an important consideration in the elderly or those who have physically demanding jobs. The drawback is that such treatments often do not deal with the underlying cause of the varicose veins, and as such there is a higher rate of vein recanalization and the patient may require further treatment at a later stage. Endovenous ablation is a technique that has been designed to achieve long-term obliteration of incompetent saphenous veins, with less invasiveness than surgery. This treatment is not yet widely available in New Zealand or public health systems, and the costs and availability of this and other newer treatments should also be taken into consideration when planning treatment with a patient.
Vein Stripping
Results from the European Randomised Trial of Endovenous Laser Ablation Versus Stripping in Patients With Primary Varicose Veins have shown that anatomically, vein stripping is more effective than endovenous ablation, in that it removed the saphenous vein in more patients, and so was associated with a lower rate of reoperation or retreatment for the original problem. However, this did not translate to better results in terms of patient reported outcomes. Measures of quality of life, pain and bruising were all better for the endovenous ablation group and there were no differences in further surgical intervention between the 2 treatments. This study has also shown that there are higher levels of complications with vein stripping, including DVT and paraesthesia. There are long term studies currently in progress to compare these 2 treatments and further analyze strengths and weaknesses of each option.
Vein stripping is performed by making a small incision in the skin and then passing a flexible plastic wire into the vein. The wire is threaded down the varicose vein to the lower end, and then brought out through a second incision. The top end of the vein is then tied around the wire, and the wire is pulled back up through the vein, pulling the vein out with it. This process is then repeated in order to strip the entire vein. The incisions are then closed with steri-strips and the leg is bandaged. Vein stripping is performed under general anaesthetic in hospital and can take between 1-1½ hours.
Ambulatory Phlebectomy
Due to it being a more invasive procedure with a longer recovery period, there is less patient preference towards ambulatory phlebectomy compared to endovenous techniques.
In ambulatory phlebectomy, there is a higher rate of wound complications compared to endovenous procedures. One study suggests that one way of minimizing this is to combine ambulatory phlebectomy with foam sclerotherapy of the remnants of the saphenofemoral junction and tributary veins to avoid the need for a phlebectomy at multiple sites over days or weeks. This may be more cost-effective for the NHS.
A randomized control trial comparing endovenous laser therapy and ambulatory phlebectomy has been undertaken. Recurrent varicose veins cause symptoms and are often due to progression of the disease that caused them in the first place. It is thought that this is usually due to the higher pressure in the larger deeper veins going back down to the saphenofemoral or saphenopopliteal junction where the vein has been interrupted. This has been called neovascularization. In this case, it is the new refluxing veins that need to be performed.
Ambulatory phlebectomy is the physical removal of the varicose veins. Local anesthetic is used to numb the skin over the veins, and small nicks are made in the skin. The veins are then removed using a special instrument. This is a minimally invasive procedure, but can cause some bruising.
Shared Decision-Making Process
In an attempt to structure the way patient preferences are elicited and incorporate them into the decision-making process, it is helpful to use a decision aid. Decision aids are tools that provide information on the options and attributes, and help guide the patient through the process of considering how important each attribute is in relation to the different options. They have been shown to increase patient knowledge about the options and the informed nature of the choice, and can also help patients and physicians clarify the decision, and bring the actual decision more in line with the patient’s preferred level of involvement. Although there are many different types of decision aids, for patient preferences elicitation, a multi-attribute approach is required, as patients need to consider the relative importance of the different attributes. This can be done using a pen and paper exercise, or a computer-based tool. An example specific to varicose veins is shown in Table 1. In some situations, it may be beneficial for the patient to complete the decision aid at home, particularly if they are uncertain as to whether or not they want treatment. This can help them make the decision in their own time. An important point to note is that decision aids are aids to decision making, and should not replace the decision itself.
After patients and physicians work together to define the decision that needs to be made, the next step is to elicit the patient’s preferences. That is, patients must be given the opportunity to express the attributes of treatment that are most important to them, and that will make their participation in the decision more likely. It is also important for the physician to understand how the patient weights the potential benefits and risks of treatment, as this will influence the decision.
Assessing Patient Preferences
More specific approaches to ascertaining patient preferences include the time trade-off technique, standard gambles, and decision analysis. Time trade-off is a simple and popular measure for obtaining utilities for health states. Utilities obtained are weighted on a scale of 0 to 1 and can be used to compare the value of different treatment outcomes to the patient. It involves asking the question “how many years of life in perfect health would you give up to avoid (state-specific health outcome) or to be cured from it?” Time trade-off has limitations for use in older populations and those with decreased life expectancies as it requires a patient to imagine a series of hypothetical scenarios and make judgments based on assumptions. Utilities can be elicited using visual or analogue scales as an alternative in these circumstances. Time trade-off has been used in a study of varicose vein treatments to compare patient preferences for different levels of risk and recurrence of symptoms.
Shared decision making should initiate with the assessment of the patient’s views on the relative importance of the outcomes of care. Roe suggested that doctors often assume they know what is best for the patient and make a decision based on the likely outcome. He gives the example of an older man with osteoarthritis who says he cannot walk to the village but can still drive to the shops. The doctor, knowing that ability to walk is a predictor of mortality, may suggest a trial of anti-inflammatory drugs in the hope that the patient will be able to walk further. The patient’s preference, however, may be to alleviate the pain in his knee to enable him to garden more, an activity with less stringent requirements regarding joint mobility. This example illustrates the need to establish what outcomes are relevant to the patient and match the treatment to the patient’s preferences.
Evaluating Treatment Options
At present, there is no single satisfactory medical or surgical treatment for varicose veins. In general, no treatment is required for thread veins or spider veins. This is because they are not a medical problem, and treatment is usually performed for cosmetic improvement. Any treatment offered on the NHS should be with health-related quality of life improvement primarily in mind. This reflects NHS executive guidance that was first issued in 1996 on the Interventional Procedures Programme. Measures aimed directly at treating the varicose veins (such as endovenous treatments or surgery) may not necessarily be the best option for some patients, particularly if they have no symptoms related to the veins. Other patients will regard the fastest possible return to work as a higher priority than the improvement of the veins themselves.
In order to reach an informed decision about varicose vein treatment, patients should understand the treatment options available to them. At present, patients are referred for a treatment if it is thought appropriate. This may limit patient choice and will definitely limit the patients’ understanding of the treatments available to them. This is particularly true regarding the different types of compression hosiery, where most UK patients are not even aware that there are four different classes of compression.
Facilitating Informed Decision-Making
The link between patient participation and improved outcomes suggests that an informed and activated patient may substantially benefit from taking a more active role in decision-making, even when the decision is difficult. Informed decision-making is a complex process that involves the integration of information with preferences. It is a fundamental part of patient-centered care, but is particularly important when there are multiple options with complex risk/benefit trade-offs such as in the management of varicose veins. Unfortunately, many patients have low levels of health literacy and struggle to understand even relatively simple risk statistics. High-quality decisions are those that are based on the considered views of well-informed, empowered patients. Achieving this is not easy, and a wide variety of decision support interventions have been developed in an effort to ensure that patients are better informed and make choices that are more consistent with their underlying preferences. An early step is to ensure that patients know that a decision needs to be made and that a choice not to treat is a valid option. This can be particularly difficult in surgical settings where there may be a strong therapeutic bias. One option may be to simply delay the decision, and it has been suggested that for many patients observation may be the best strategy. To help patients understand the nature of the decision and the attributes of different treatments, it may be helpful to use decision aids; these can be verbal, written, or visual and help patients to consider the options and clarify the potential risk and benefits of each. This ideally will lead to the identification of the best course of action to meet the patient’s individual goals. A systematic review of decision aids for people facing health treatment or screening decisions has shown that these tools lead to better patient knowledge regarding treatment and its associated risks, more accurate risk perceptions, and patient choices more in keeping with their individual risk or outcome utility. The same systematic review found that there was no evidence that decision aids increase anxiety or lead to people making decisions that are overly risk averse. If a high-quality decision results in a decision to take action, then it would be hoped that the chosen treatment is consistent with the informed preferences of the patient.
