Modern Management of Chronic Venous Insufficiency - Core

12702#5 18/6/03

Current Opinion

Modern Management of Chronic Venous Insufficiency Andrew W. Bradbury, Department of Vascular Surgery, Birmingham Heartlands Hospital, Research Institute, Birmingham, United Kingdom.

Introduction In Caucasians, the life-time risk of developing varicose veins (VVs) is 30% to 50%; for venous hypertensive skin changes of chronic venous insufficiency (CVI), it is 5% to 10%; and for chronic venous ulceration (CVU), it is around 1%.1–3 In most European countries and in North America, the treatment of CVI consumes approximately 2% of total health care spending4 and is a major cause of lost economic productivity through sickness and absence from work. Similar data for Asian countries appear unavailable, at least in the English-language literature. However, there is no reason to believe that other ethnic groups and races are immune from a disease that appears to be a direct consequence of Homo sapiens’ bipedal posture. Given that CVI is generally accepted to be a leading worldwide cause of medical and socio-economic morbidity, one would expect health care purchasers to place a high priority on its treatment, those treatments to be evidence-based and clinically- and cost-effective and, where that is not the case, funding bodies to be keen to fund clinical and basic science research.5 In the UK, where VV surgery is the commonest cause of litigation against general and vascular surgeons,6–8 where those in charge of the National Health Service (NHS) purse-strings constantly try to ration the treatment of CVI, and where venous disease receives a low priority in the allocation of research monies, nothing could be further from the truth. No doubt, similar constraints face practitioners in other countries. How has this state of affairs come to pass? There are two main reasons: firstly, until recently, we have been unable to demonstrate that surgery for CVI ameliorates the physical symptoms (as opposed to the cosmetic concerns) associated with VVs9,10 or confers additional benefit over the “best medical therapy” in terms of preventing, healing and reducing the recurrence of CVU. Secondly, many patients with lower limb

venous disease find the current levels of morbidity and longterm failure11 associated with conventional venous surgery unacceptable. The first has led researchers to devise and construct trials that will provide “level 1” evidence (i.e. evidence based on clinical and health economic data derived from randomized controlled trials) of clinical and cost-efficacy; the second has led doctors and patients alike to search for alternative, minimally invasive therapies to replace conventional surgery.12

Quest for the evidence base Until recently, the evidence base for what we were taught at medical school about treating lower limb venous disease was virtually non-existent.13 However, in recent years, there have been major steps forward in our understanding of the pathophysiology14,15 of the disease and its diagnosis and treatment.16 With regard to long saphenous vein (LSV) VV surgery, we now have ample level 1 evidence to show that the most important component of the operation is stripping of the LSV in the thigh.17–20 This paradigm shift has allowed for the rational introduction of new, minimally invasive techniques.21 We also know that superficial venous surgery, whether performed for uncomplicated VVs or the more severe dermatological manifestations of CVI, is associated with a significant improvement in health-related quality of life.18–22 Very recently, the ESCHAR study, a randomized controlled trial (RCT),23 confirmed the findings of uncontrolled studies24 that the addition of saphenous surgery to compression therapy significantly reduces recurrence of CVU.

Sub-fascial endoscopic perforator surgery For a while, great hopes and expectations accompanied the advent of sub-fascial endoscopic perforating surgery (SEPS).25

Address correspondence and reprint requests to Professor Andrew Bradbury, Department of Vascular Surgery, Birmingham Heartlands Hospital, Research Institute, Lincoln House, Bordesley Green East, Birmingham B9 5SS, United Kingdom. E-mail: [email protected] • Date of acceptance: 31st December, 2002 © 2003 Elsevier. All rights reserved.

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Like many practitioners, the author performed a large number of procedures, believing intuitively that the interruption of high-pressure venous flow from the deep compartment of the calf to the skin of the gaiter area would be beneficial.26 However, while the procedure can certainly be performed expeditiously with a minimum of morbidity,27 it is now clear that many perforators regain competence once saphenous reflux has been abolished.28 Furthermore, although the North American SEPS registry reported encouraging ulcer healing rates, longerterm follow-up to 2 years revealed disappointing recurrence rates similar to those obtained by compression therapy alone. This was especially so in patients with deep venous reflux, particularly where this was believed to be post-thrombotic in aetiology.29,30 While the author believes that the procedure still has a role in the management of CVI, its benefits over compression and/or saphenous surgery alone may be small and restricted to certain subgroups of patients. There are no short cuts, and the surgical community must be prepared to work together to complete scientifically credible RCTs to tease out the answers to these difficult questions. The author is a co-investigator in such an ongoing, UK-based, Medical Research Council-funded RCT, in which the results will hopefully be reported in 2005 or 2006. Other trials are also underway in the UK and elsewhere and have yet to report their findings.

the quicker recovery time will translate into an overall “cost savings for society”.32 Whether this turns out to be the case remains to be seen and will, of course, depend on the particular health reimbursement system at work in each individual country.

Quest for new treatments

Foam sclerotherapy

In an attempt to improve outcomes and minimize morbidity, a number of novel, minimally invasive alternative therapies have been developed and promoted in recent years.

Radio-frequency ablation Perhaps the best known and documented of the new techniques is radio-frequency (RF) ablation of the LSV in the thigh (Closure Technique, VNUS Medical Technologies Inc., Sunnyvale, CA, USA, www.vnus.com). An RF catheter is introduced percutaneously into the LSV, advanced to the sapheno-femoral junction, heated, and then withdrawn slowly under duplex ultrasound guidance. A recently published registry of 286 patients from 30 different sites in North America and Europe has indicated that the VNUS procedure leads to LSV occlusion in almost 90% of patients 24 months post-procedure.31 A small RCT of 28 patients has shown VNUS to be associated with less post-procedure morbidity and an earlier return to full physical function. Although the initial financial outlay for VNUS is greater than for conventional surgery, the authors argue that

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Endovenous laser therapy In principle, endovenous laser therapy (EVLT) (Diomed Ltd., Cambridge, UK, www.evlt.com) is quite similar to VNUS Closure, except that the LSV is obliterated using a laser. Although there are fewer data currently available in the literature, short-term results in small numbers of patients treated in uncontrolled studies of EVLT suggest that the incidence of vein obliteration is similar to that experienced after VNUS Closure.33

Powered phlebectomy (TriVex) Smith and Nephew (Smith & Nephew Plc., London, UK, www.smith-nephew.com/businesses/E_trivex.html) have developed this device, which morcelates and removes varices, so replacing the need for multiple stab avulsions or sclerotherapy following LSV obliteration.34,35 The advantages are fewer skin incisions and greater speed, especially when performing bilateral surgery. The latter may extend the role of day surgery in such patients.

The idea that sclerosants can be mixed with air and other gases to increase their efficacy in not new.36 However, it was not until Cabrera published his results with “foam” that the concept was popularized.36 The main advantage of foam over liquid sclerosant is that it completely displaces all the blood from the vein being treated, which then almost immediately goes into intense spasm. This reduces the risk of thrombophlebitis. Even very large trunk varices can be treated with quite small volumes of weak sclerosant. Cabrera patented his discovery and Provensis Ltd., a wholly owned subsidiary of the British Biotechnology Group Plc. (www.btgplc.com), was created to develop Cabrera’s intellectual property in relation to the foam. The resultant product, Varisolve, is comprised of 1% polidocanol and a mixture of physiological gases. The foam is introduced into the LSV, or short saphenous vein, via a cannula that is placed percutaneously under duplex ultrasound control, under local anaesthesia. As the foam is highly echogenic, it can be delivered in an extremely controlled and precise way to fill the whole main trunk up to, but not beyond, the sapheno-femoral or sapheno-popliteal junctions.


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As Varisolve is highly surface active, it also quickly fills and obliterates all the distal varices; experience suggests that most patients’ VVs are eradicated following a single treatment. Trials comparing Varisolve to surgery and other forms of sclerotherapy are currently underway in Europe, including the UK, in order to gain FDA approval and European licences. Will these new techniques pose a serious “threat” to conventional surgery? In countries like the UK where most surgery for CVI is paid for by the public sector, these new and often more expensive and complex procedures are unlikely to have a dramatic impact on overall practice. However, in countries where private sector health care is predominant, and where patient preference and convenience are paramount and costs are less important, these new techniques and their proponents are more likely to prosper. However, training in patient selection as well as in the performance of the procedure itself is going to be crucial to optimizing results. To their credit, all of the companies involved have embarked upon such training programmes, not least because they realize that complications and bad results will dent confidence in their product and limit the return on their R&D investment.

Conclusions There has never been a more interesting or rewarding time to be involved in the treatment of CVI. Our improved understanding of the macro- and microvascular abnormalities that lead to its symptoms and signs has enabled us to refine existing treatments and develop new techniques that are likely to provide our patients with a safer, more pleasant treatment experience and better long-term outcomes. However, with that comes a responsibility to ensure that the management of our patients is evidence-based, that we audit and report our results wholly and truthfully (whether they are good or bad), and that we maintain the highest scientific standards when conducting clinical and basic science research into venous disease.37

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