SURGICAL AND ENDOVASCULAR OPTIONS IN THE TREATMENT OF SUPERFICIAL VENOUS PATHOLOGY

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1 Journal of Experimental Medical & Surgical Research Cercetãri Experimentale & Medico-Chirurgicale Year XVII Nr.1/2010 Pag JOURNAL Experimental Medical of Surgical R E S E A R C H SURGICAL AND ENDOVASCULAR OPTIONS IN THE TREATMENT OF SUPERFICIAL VENOUS PATHOLOGY R. Bistreanu, P. Dormal 1 SUMMARY: Chronic venous insufficiency continues to be a major source of disability and cost, with accompanying socio-economic burdens. Great saphenous vein reflux is the most common form of superficial venous pathology and is frequently responsible for varicose veins of the lower extremity. Therefore, therapy directed toward correcting superficial venous reflux is beneficial to many patients. A widespread surgical technique consists of high ligation of the saphenofemural junction associated with stripping and multiple avulsions of vein clusters. Recently, different new surgical approaches have been developed to reduce the potential disadvantages of this conventional therapy. Endovenous techniques, such as radiofrequency obliteration and laser treatment, were introduced like minimally invasive alternatives. Our study was performed on a group of 136 patients, who benefits of venous surgery in Surgical Departement of C.H.R Mouscron (Belgium), across the year Majority of patients were admitted in service for one-day hospitalisation. We examined the options of conventional surgery, but also the endovenous technique of radiofrequency ablation. We compared these approaches in terms of the indications, limits, complications and costs. Short-term advantages (reduced postoperative pain, faster return to normal activities) appeared to be associated with endovenous treatment, but long term follow-up results is more important to evaluate this technique. The cost of the devices is significantly high compared with standard stripping, and specific skills, particularly to perform a duplex scan, are needed. Ligation with stripping plus phlebectomy is generally regarded as the standard for treating primary reflux in saphenous vein. Current evidence from literature suggests that radiofrequency ablation is as safe and effective as surgery, particularly in the treatment of saphenouts veins. Most important, the type of varicose vein should govern intervention s choosing, with no single treatment universally employed. Key Words: superficial venous surgery, endovenous techniques, radiofrequency ablation. Received for publication: Revised: Centre Hospitalier de Mouscron, Belgium OPÞIUNI CHIRURGICALE ªI ENDOVASCULARE ÎN TRATEAMENTUL PATOLOGIEI VENOASE SUPERFICIALE Rezumat: Insuficienþa venoasã cronicã reprezintã o condiþie patologicã invalidantã ºi generatoare de costuri, cu implicaþii socio-economice importante. Refluxul la nivelul venei safene mari este cel mai frecvent întâlnit în patologia venoasã superficialã, fiind responsabil de apariþia varicelor membrului inferior. De aceea, tratamentul ce vizeazã corectarea refluxului venos superficial este benefic pentru cei mai mulþi pacienþi. Crosectomia cu stripping-ul safenei mari, însoþite de excizii de pachete varicoase, reprezintã o opþiune chirurgicalã larg rãspânditã în toatã lumea. În ultimii ani, s-au dezvoltat noi abordãri chirurgicale, pentru a reduce potenþialele dezavantaje ale tehnicilor convenþionale. Tehnicile endovenoase, ca ablaþia prin radiofrecvenþã ºi tratamentul laser, au fost introduse ca alternative minim invazive. Studiul nostru a fost efectuat pe un lot de 136 pacienþi, operaþi în 2009 la nivelul Spitalului Regional Mouscron, Belgia. Majoritatea pacienþilor au fost internaþi în serviciul de spitalizare de zi. Am studiat opþiunile chirurgicale convenþionale, dar ºi tehnica endovenoasã de ablaþie prin radiofrecvenþã. Am comparat aceste douã abordãri în privinþa indicaþiilor, limitelor, complicaþiilor ºi costurilor. Avantajele pe termen scurt aparþin tehnicii endovasculare, dar urmãrirea rezultatelor pe termen lung este mai importantã pentru a evalua aceastã procedurã. Costul echipamentelor ºi materialelor este semnificativ mai mare în comparaþie cu stripping-ul, fiind necesare ºi abilitãþi particulare, în special efectuarea Duplex scanului. Crosectomia cu stripping ºi flebectomii reprezintã tehnica standard în cazul refluxului primar la nivelul safenei mari. Dovezile existente în literatura de specialitate sugereazã cã ablaþia prin radiofrecvenþã este la fel de sigurã ºi eficientã ca procedeul chirurgical, în special în cazul venei safene. Este mai important ca tipologia venelor varicoase sã ghideze alegerea tehnicii, pentru cã nu existã o procedurã general valabilã pentru toate cazurile. Correspondence to: Romeo Bistreanu,. romeobistreanu@yahoo.com 50

2 INTRODUCTION Varicose veins represent a frequent disorder with prevalence in adult populations between 14% for large varices and 59% for small teleangiectasies(1). The term venous chronic insufficiency(cvi) defines functional abnormalities of the venous system producing advanced symptoms like oedema, skin changes or leg ulcers. Both entities, varicose veins and CVI, may be summarized under the term chronic venous disorders (1) which includes the full spectrum of morfological and functional changes. A classification system(2) to describe venous chronic disorders has been proposed under the acronym of CEAP(clinic, etiologic, anatomic, pathophysiologic). The revised version of the CEAP clasification contains also definitions of clinical signs and suggests three levels of investigations adjusted to the clinical stage. Surgery plays an important role in the treatment of varicose veins. There is a degree of consensus with respect to recommending to surgery in large or complicated varicose veins. The indications are mainly based on the clinical examination, but duplex ultrasound assessment must be systematic prior to any procedures. The newer endovascular treatments of varicose veins have been adopted, using laser, radiofrequency ablation and chemical foam sclerotherapy. Endoluminal surgery will assume increasing importance in the future. MATERIAL AND METHODS Our study was performed on a group of 136 patients who benefits of venous surgery in Surgical Departement of C.H.R Mouscron (Belgium), across the year The venous history of each patient, risk factors and other important pathologies were mentioned in medical records. The clinical examination is irreplaceable for assessment of chronic venous disease. It enables the C section of the CEAP classification to be completed, but requires further non- invasive investigations( Doppler ultrasound and, above all, duplex ultrasound) in order to complete sections E, A and P. The aim of our study was to evaluate the active treatment of varicose veins, directed to suppress the pathological superficial veins. Surgery, endovenous techniques and sclerotherapy share the same objective. We examined the options of conventional surgery, but also the endovenous technique of radiofrequency ablation (VNUS-Closure procedure). We compared these approaches in terms of the indications, principles, limits, complications and costs, using also findings of literature review. RESULTS AND DISCUSSIONS In the group of admitted patients(136) we found these characteristics: - predominents groups of age:51-60 years(38 cases), years(37 cases) - distribution by sex: 67% women, 33% men - time of hospitalisation: 1-4 days(91 % of patients in one-day admission) In practice, the active treatment was made through dual objective: elimination of dilated superficial veins, whose valves are most frequently incompetent elimination of the refluxes from the deep vein system toward the superficial venous system, by eliminating the pahological leakage points; reflux occurs when the terminal valves of the saphenous trunks and the valves of the perforators are incompetent. In many cases of our study, Doppler ultrasound has confirmed that truncal and tributaries valve insufficiency is associated with pathological leakage points and the interventions must combine the two objectives. Duplex ultrasound mixes ultrasonographic imaging with pulsed Doppler ultrasound, with precise identification of refluxes and of incompetent segments, to obtain a preoperative venous mapping. Consequently, the surgical interventions were practiced and we present them for our goup: tributaries phlebectomy=44 cases Radiofrequency obliteration = 4 cases perforator ligation= 30 cases tributaries phlebectomy+ perforator ligation = 21 cases Sapheno-popliteal disconection + small saphenous stripping + phlebectomy= 12 cases Sapheno-popliteal disconection + small saphenous stripping + phlebectomy + perforator ligation = 5 cases Phlebectomy + perforator ligation = 20 cases( 13 for reccurence, 7 cases for residual varices) Postoperative care included regularly these measures: - elastic compression (with bandages) for a variable time(depending of each case) - prophylaxis of thromboembolic events with low-weight molecular heparin(10 days) 51

3 Traditional techniques for removal of the great saphenous vein typically have employed ligation at sapheno-femoral junction(sfj) and ablation of the vein between the groin and ankle(or knee) using a stripping technique. Another goal of high ligation is to identify and divide all venous branches communicating with the SFJ, to minimize the potential for reccurent reflux pathways. However, it is a theory suggesting that dissection in groin region represents a stimulus for neovascularization, followed by reccurence. There is a hope that endovenous techniques may prove to be associated with a lower incidence of reccurent venous insufficieny after intervention(3). Numerous methods have been described for removal of the saphenous vein after ligation. The current trend is toward minimizing the invasiveness of intervention and some alternatives to surgical stripping have been introduced. However, it should be noted that stripping procedures themselves have undergone a significant evolution. Using minimal incisions, tumescent local anesthesia, ultrasound guidance and careful dissection, great saphenous vein can be removed through two small incisions with relatively little bruising or postoperative discomfort(in the majority of cases). Correction of saphenous and perforator insufficiency will improve hemodynamics with reliable reduction in symptom severity. However, to many patients, the primary sign of their vein problem is the visible varicosities and most prefer ablation of them whenever necessary. In conventional surgical tretment, this typically has been performed at the time of saphenous stripping, taking advantage of the anesthetic and eliminating the need for subsequent procedures. Since the introduction of endovenous ablative techniques, some patients are treated initially with endovenous saphenous obliteration; ambulatory phlebectomy or sclerotherapy may be performed in secondary session. Radiofrequency obliteration(rfo) uses a percutaneous heat-generating bipolar catheter for endovenous obliteration of an incompetent vein. A computer-controlled radiofrequency generator creats a temperature of 85 0 C at the vein wall, causing intima venous destruction, plus shortening and contraction of the collagen fibers, which finally results in the collapse of the vein. The system proposes two different sizes of closure catheters(6 Fr or 8 Fr) to treat veins with diameters up to 12 mm. Each catheter includes a thermocouple to measure vein wall temperature and to control appropriate impedance. In addition, each catheter has a central lumen for fluid infusion and potential passage over a guide wire(4). 52 Percutaneous ultrasound-guided or minimal surgical access is performed at the knee or upper calf for the great saphenous vein. The adequate closure catheter is passed prograde through the vessel and positioned in the sapheno-femural junction. The limb is elevated and an elastic bandaged is placed from the toes to the groin, excluding blood flow from the superficial veins. Once the tip of the catheter is positioned as close to the common femoral vein as possible, it is gradually withdrawn while generating heat, at a maximum of 3 cm /minute. To avoid skin burns, especially when the vein is too superficial, subcutaneous tumescent solution must be infiltrated to separate vein and dermis. The whole procedure is performed under duplex scan control until the obliteration of the vein is obtained. Contraindications and limits for RFO The absolute contraindication to radiofrequency obliteration, from technical point of view, is the patient with a pacemaker or an internal defibrilator. The other limits of this minimal invasive procedure are the tortuosity of saphena magna, vein diameter(<2 mm or >12 mm) and the presence of major incompetent tributaries: - tortuosity of the great saphenous vein is clearly associated with the risk of inability to pass the RFO catheter, or the risk of vessel wall perforation in an attempt to pass through the vein; - a vein with a diameter less than 2 mm is too small to allow the appropriate RFO catheter introduction and a vein greater than 12 mm prevents the adequate radiofrequency obliteration; - major incompetent tributaries left close to the sapheno-femural junction, espescially anterolateral or posteromedial tributaries, are possibly known to develop reccurent reflux and new varicosities. In our group of study, we noticed another situation to avoid RFO: an important reflux in sapheno-femural junction, who was treated by surgical ligation. As in most innovative procedures, the RFO requires a learning curve and demandes great skill in duplex ultrasonography handling(5). Major complications reported in the literature are related to thermal injuries and include skin burns and nerve damaged. The treatment of great saphenous vein limited to the thigh and upper leg significantly reduces the incidence of nerve paresthesia and dysesthesia(6). Uncommon complications are the thrombus extension into the common femural vein and the development of deep venous thrombosis or pulmonary embolism. An

4 early postoperative duplex ultrasonography is recommended to identify this potential complication. A minor complication observed is the coagulum accumulation on the electrodes, with consequent increasing impedance which finally impedes the procedure advancement. To minimize this complication, each catheter has a central lumen for heparinized fluid infusion. Table 1.Characteristics, costs and mechanisms of action Special equipment Disposable device Ultrasound equipment Mechanisms of action Conventional surgery Cost: 0 euro Stripper Cost: 10 euro The incompetent vein is stripped Radiofrequency obliteration Vnus RF generator Cost:13000 euro Closure bipolar catheters( 6 or 8 Fr and 60 or 80 cm) Cost: 500 euro Yes Cost: euro Heating of the vein wall causes intimal damage, contraction and irreversible shrin-kage of collagen fibers Table 2.Main surgical characteristics of different techniques Access Ligation of sapheno-fem oral junction Tumescent solution Groin tributarie s Great sapheno usvein Varicose vein clusters Classic surgery Surgical access Surgical ligation All veins ligated Surgically stripped Adjunctive phlebectomy or sclerotherapy RFO Percutaneous or minimally surgical access Recommended All veins not usually obliterated Endove-n ous GSV occlusion Adjunctive phlebectomy or sclerotherapy Table 3. Adverse events and results of these techniques Adverse events Results Time of return to work Conventional surgery 1.Nerve injury 2.Haematoma formation 3.Wound infection At 2 years: reccurent VV-20,9 to 25%(7) 11,4-12,4 days(4,8) 1.Nerve paresthesia 2.Thermal skin injury RFO 3.Tehnical failure 4.Deep vein thrombosis 5.Vessel perforation At 2 years: reccurent VV-14,3%(7) 4,7-7 days(4,8) 6.Haematoma 7.Clinical phlebitis 53

5 If we want to resume and compare these two strategies, we present the characteristics, costs and mechanisms of action for treating superficial vein disease(table 1). The problem of costs is very important, because of changing of legislation in Belgium: medical insurances has stoped to cover RFO procedures and the number of cases diminished in 2009 (in comparation with 2008). The surgical principles of each procedure are presented in table 2. When it s practiced classic surgical technique, adjunctive phlebectomies are performed in the same time, but in RFO procedures these are sometimes postponed for a second time. The postoperative complications and effectiveness of treatment(table 3) can be well-evaluated from literature review, because of significantly high number of cases. Ecchymosis, hematoma, pain, induration and phlebitis are some adverse effects associated with both procedures, but in most cases they are self-limited. Local ecchymosis, tenderness and hematoma are minimized in endovascular procedure. The early return to normal activity and work should be treated with caution, depending by the nature of job and whether the patient is self-employed or not. Lurie et al(7) suggested that RFO is associated with less neovascularization than conventional surgery, but in other meta-analysis(8) this was not confirmed. The reccurence rate after two years was numerically lower in the RFO group(7), but it was not statistically significant due to insufficient numbers of cases. CONCLUSIONS Radiofrequency obliteration is a minimal invasive technique for the treatment of superficial venous disease. In primary reflux of saphenous vein, the present standard remains high ligation with stripping and any alternative therapy must have the same or better outcome. The endovascular technique with radiofrequency has a higher cost and selected indications. Short-term advantages (reduced postoperative pain, faster return to normal activities) appeared to be associated with endovenous treatment, but significant results will come after long term follow-up. REFERENCES 1. Partsch H., Varicose veins and chronic venous insufficiency, Vasa.2009,Nov;38(4): Beebe HG,Bergan JJ,Berqvist D et al.classification and grading of chronic venous disease in the lower limb: a consensus statement.phlebology 1995;10: Ramelet A.A.,Kern Ph., Perrin M., Varicose veins and telangictasias,2004, Elsevier SAS. 4. Lurie F., Creton D.,Eklof B.et al.prospective randomised study of radiofrequency obliteration versus ligation and striping in a select patient population(evolves Sudy).J Vasc Surgery, 2003,38: Scavee V.,Current trends in superficial venous surgery.acta chir belg. 2006, 106: Sybrandy J.,Writtens C., Initial experiences in endovenous treatment of saphenous vein reflux. J Vasc Surgery, 2002, 36: Lurie F., Creton D.,Eklof B. et al. Prospective randomised study of radiofrequency obliteration versus ligation and striping(evolves):two year follow-up. Eur.J.Vasc.Surgery 2005, 29: Luebke T.,Gawenda M.et al.meta-analysis of endovenous radiofrequency obliteration of great saphenous vein in primary varicosis. Journal of Endovascular Therapy, 2008, Vol 15.Issue 2. 54