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Surg Clin N Am 84 (2004) 1397–1417 New approaches for the treatment of varicose veins Theodore H. Teruya, MD, FACSa, Jeffrey L. Ballard, MD, FACSb,c,* a Division of Vascular Surgery, Loma Linda University, 11175 Campus Street, Loma Linda, CA 92354, USA b 1140 W. La Veta Avenue, Suite 850, Orange, CA 92868, USA c University of California, Irvine, Irvine, CA 92868, USA Varicose veins are a common problem encountered by multiple different specialists. The challenge for the surgeon dealing with varicose veins has always been balancing a cosmetically acceptable result with a low incidence of recurrence and complications. Increasingly well-informed patients who pressure the treating surgeon for cosmetically acceptable results in conjunction with expansion of minimally invasive techniques have made the treatment of superficial venous reflux and varicose veins a rapidly evolving field. Clinical presentation The clinical presentation of patients with varicose veins can be variable, and many patients have minimal or no symptoms. When present, symptoms are usually localized over the area with varicose veins or generalized to include global lower extremity complaints. Localized symptoms include pain, burning, or itching, whereas generalized symptoms consist of leg aching, fatigue, or swelling. Women are more prone to these symptoms due to hormonal influences [1]. Men will often develop symptoms after the varicosities have enlarged to sufficient size to increase pressure on somatic nerves. Symptoms are often worse at the end of the day, especially after episodes of prolonged standing. There does not appear to be a correlation with the severity of the varicose veins and the severity of symptoms. * Corresponding address. 1140 W. La Veta Avenue, Suite 850, Orange, CA 92868, USA. E-mail address: [email protected] (J.L. Ballard). 0039-6109/04/$ - see front matter Ó 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.suc.2004.04.008 1398 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 Varicose veins and reflux involving the superficial venous system can lead to venous ulceration; however, varicose veins are most often a benign problem that will not lead to serious health problems. Of patients with venous ulceration of only 17% will have isolated superficial venous reflux as the etiology. Large varicose veins may lead to skin changes and eventual ulceration [2]. Notwithstanding the above potential consequences of varicose veins, most patients find varicose veins unsightly, and seek treatment for cosmetic reasons. Optimal cosmetic results are paramount, particularly because young women are commonly affected by this disease. This expectation has made minimally invasive techniques extremely attractive, and these are widely used in the treatment of superficial venous reflux and symptomatic varicose veins. Anatomy and physiology The greater saphenous vein (GSV) originates in the dorsum of the foot in the dorsal venous arch and passes anterior to the medial malleolus. The vein then travels in the medial leg to and through the posterior medial aspect of the popliteal space. It continues its course through the medial thigh to join the femoral vein at the fossa ovalis. This junction is known as the saphenofemoral junction (SFJ), and there are a variable number of tributary veins that converge at this junction. The saphenous vein lies in a plane between the deep and superficial fascia of the lower extremity. The saphenous vein connects with the deep venous system directly via the Hunterian and Dodd perforating veins in the thigh. There are indirect communications with the deep system via the posterior arch in the leg [3]. Blood in the lower extremity venous system is returned to the heart via the calf muscle pump, residual force from heart contractility, and negative intrathoracic pressure. Venous valves in the lower extremity are important in maintaining unidirectional flow. When valvular dysfunction occurs, blood will reflux, leading to hypertension in the venous system. This can be in the deep system, superficial system, or perforating veins, or any combination of the three. The most common location for venous reflux is in the GSV, and this often leads to the development of varicose veins. GSV reflux is usually due to primary valvular incompetence. No identifiable etiology can be elucidated in most cases, and the valvular dysfunction is presumed to be due to a loss in vein wall elasticity with failure of the valve leaflets to coapt [4]. Preoperative evaluation History and physical examination are very important in the evaluation of patients with venous disease. Risk factors associated with varicose veins T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1399 include increasing age, a chronic activity that involves prolonged standing, history of phlebitis, female gender, multiple pregnancies, and family history [5–7]. It is critical to determine the level of disability that the patient associates with their varicose veins. The question that will eventually arise will be whether or not the varicose veins are simply a cosmetic issue. When there are perceived as symptomatic, this observation should be differentiated into a minor annoyance or a lifestyle-limiting problem. It is also important to determine if there are other etiologies causing the patient’s symptoms [8]. Occasionally, patients with varicose veins will associate other musculoskeletal symptoms with their varicose veins. If symptoms are not consistent with varicose veins, then there is a low likelihood of relief, with treatment specifically aimed at varicosities. A past history of superficial thrombophlebitis or deep-venous thrombosis is important for prognosis, and surgical expectations will need to be tempered. Quality results may also be undermined by significant deep venous reflux, history of ulceration, or congenital arteriovenous malformations. A careful physical examination should be done to determine the nature, extent, and location of varicose veins. The presence of edema and skin changes should also be noted. These skin changes include eczema, hyperpigmentation, and lipodermatosclerosis. Patients with large varicose veins or patients with skin changes should be offered treatment specifically designed to avoid future ulceration. Peripheral arterial disease should be ruled out as a cause of the patient’s symptoms. Finally, the musculoskeletal system should be briefly assessed to determine if there is a rheumatologic or orthopedic problem responsible for the lower extremity pain complaints. Before the widespread use of duplex ultrasound in the evaluation of patients with chronic venous insufficiency (CVI), the hand-held Doppler probe was an essential adjunct to the physical examination. A gross determination of reflux can be made by squeezing the lower extremity distal to the probe and insonating over the GSV in the leg and thigh as well as at the popliteal fossa and femoral triangle. Formal noninvasive imaging of the venous system with duplex ultrasound will confirm the etiology, anatomy, and pathophysiology of segmental venous reflux. This test is a safe, noninvasive, and cost-effective method of determining reflux in the superficial, deep, and perforating venous systems. The examination uses a high-resolution duplex ultrasound machine with pulsed and color Doppler using a 5- to 7.5-MHz transducer probe. Thigh and calf cuffs that rapidly inflate and deflate are essential components of the examination (Hokansen, Bothell, Washington). Modern duplex ultrasound has made most other clinical tests for venous disease unnecessary. Initial evaluation of the venous system is performed to determine the presence or absence of obstruction in the deep or superficial venous system. Duplex interrogation of various portions of the superficial and deep venous systems is then performed with rapid cuff inflation and subsequent deflation. 1400 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 The cuff is rapidly deflated after 3 seconds of inflation and the ultrasound probe is positioned distal to the cuff to assess for reversed flow within the imaged vein segment. The diagnosis of reflux will be made if there is reversal of flow for longer than 0.5 seconds after cuff deflation [9,10]. Conservative management Graduated compression stockings remain the first line therapy for patients with primary venous disease. This form of therapy is relatively inexpensive, essentially risk free, and can be effective in improving symptoms related to superficial venous reflux and varicose veins. It is unclear exactly how compression stockings improve symptoms. However, they definitely seem to reduce leg edema, and may decrease the pressure that is distributed to somatic nerves by venous reflux. For patients who consider varicose veins to be unsightly, compression stockings are unlikely to be accepted as primary therapy. Patient compliance is the major factor causing failure of compression therapy. Operative planning Successful treatment of varicose veins requires a balance between their complete removal with treatment of the underlying etiology and an optimal cosmetic outcome. The underlying cause of venous hypertension must be addressed or recurrence of the varicosities can be expected. In most cases, saphenous vein reflux is the underlying primary problem. Thus, recurrence of varicose veins is often related to inadequate initial treatment of reflux in the GSV or lesser saphenous vein (LSV). Treatment failure can be a result of inadequate removal or ablation the refluxing saphenous vein, missing a duplicated venous system, or insufficient ligation/ablation of venous tributaries at the SFJ. High ligation of the GSV without its removal or ablation will also lead to a high rate of treatment failure and varicose vein recurrence [11–13]. In some cases, varicose vein recurrence is not solely the result of an inadequate surgical procedure. Recurrence may be due to persistent venous hypertension from sources other than the treated saphenous vein. Even successful surgery will not negate a genetic tendency to develop varicosities from vein wall weakness [14,15]. Another possible cause of recurrent varicose veins is neovascularization at the SFJ from dissection in this area [16,17]. Complete treatment of clinically symptomatic varicose veins must therefore involve treatment of the saphenous vein reflux as well as the varicosities. Current strategies designed to eliminate reflux within the saphenous vein include surgical stripping, radiofrequency ablation (RFA), and endovenous laser ablation. Varicose veins can be treated with stab avulsions and transilluminated powered phlebectomy. Finally, foam sclero- T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1401 therapy holds promise for treatment of saphenous vein reflux and varicose veins. Treatment of saphenous vein reflux Surgical stripping The primary objective of treatment of primary CVI should be ablation of the hydrostatic forces of axial reflux. In some severe forms of CVI this may be accompanied by removal of the hydrodynamic forces of perforator vein outward flow. Until recently, commonly used methods of surgical treatment of the saphenous vein consisted of either high ligation or disconnection of the vein from either the SFJ or saphenopopliteal junction (SPJ) combined with stripping. High ligation alone was considered a ‘‘simple fix,’’ and offered the advantage of decreased bleeding and pain and a lower incidence of wound infection. This procedure also had the theoretical advantage of preserving the GSV for later use as a conduit for arterial or coronary bypass procedures. Unfortunately, high ligation without saphenous vein stripping fails to eliminate axial reflux in most patients. In a classic study by Lofgren and Lofgren at the Mayo Clinic, high ligation of the GSV was compared with groin to ankle stripping [18]. Excellent results were achieved in most patients who had GSV stripping (94%) compared with only 40% of the patients who underwent high ligation alone. GSV stripping was associated with better immediate results and a decrease in the long-term varicose vein recurrence rate [18]. This has been confirmed by several prospective studies [12,13,19,20]. Therefore, high ligation of the saphenous vein should be reserved for special circumstances only. It is not appropriate as the primary procedure of choice for the treatment of superficial venous reflux. The technique of saphenous vein stripping is relatively simple, and will be described below for the GSV. An oblique incision is made cephalad to the groin crease just medial to the femoral artery pulse. Tributary veins about the SFJ should be dissected well into the periphery before they are ligated and divided. If the tributaries are large, they can be excised in a fashion similar to the saphenous vein by passing a stripper into the vein and retrieving it with a small cutdown over the subcutaneously palpable end of the stripper. After all the obvious tributary veins are ligated, the SFJ (or SPJ) is identified and this area should be closely inspected for additional tributaries. After addressing all venous tributaries that are emanating from the SFJ, the saphenous vein can be disconnected from the junction after application of a vascular clamp on the femoral vein. The short stump of remaining saphenous vein should be oversewn with prolene suture flush with the femoral vein. A stripper is then passed distally into the GSV, and in most cases there is little difficulty passing it in this direction. This is due to the fact that a refluxing 1402 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 saphenous vein has few to no competent valves. Occasionally, the stripper will pass into large anterior or posterior tributaries, and by withdrawing and redirecting the stripper it can be passed successfully through the saphenous vein. Once the stripper is passed to just below the skin creases at the knee level a small skin incision is made over it for retrieval. The saphenous vein is then divided and ligated distal to the retrieved stripper. The GSV at the groin is securely attached to the stripper with a sturdy suture ligature. We do not use any of the end attachments that come in the stripper packaging. In addition, a long heavy silk suture is tied to the end of the stripper so that this suture will pass through the subcutaneous tunnel created by the stripped out saphenous vein. The saphenous vein can now be stripped from groin to proximal leg using a slow pull on the distal end of the stripper. The firmly attached saphenous vein will invert on itself, and as it is stripped distally will actually pull away from subcutaneous tissue and any surrounding nerve. A standard 4 Â 4 gauze sponge, which has been soaked in lidocaine with epinephrine, can be unrolled and now attached to the heavy silk ligature that followed the vein as it was stripped distally. This hemostatic gauze pack can be pulled into the subcutaneous tunnel left by the excised vein and removed from the groin incision after varicose vein excision. Rarely the saphenous vein will avulse during the inversion stripping, and the gauze also facilitates the removal of any remaining vein segments. After saphenous vein stripping, previously marked varicose veins can be treated in turn using the various methods that will be subsequently described. The skin incisions used for vein stripping are closed in two layers; the lower extremity is wrapped from foot to proximal thigh with compressive gauze and an elastic wrap to minimized hematoma formation [21]. One drawback to saphenous vein stripping is the complication of saphenous nerve injury. This can occur when the saphenous vein is avulsed 7 to 13 cm below the knee crease or when the saphenous vein is stripped from ankle to groin. Once felt to be rare complication, a recent study demonstrated saphenous nerve deficits, on physical examination, in 58% of patients who had stripping to the ankle level [22]. However, only 40% of patients reported symptoms of saphenous nerve injury [22]. Only 6.7% of patients noted an affect in their quality of life at any time subsequent to the surgery. At the time of latest follow-up examination, only one patient reported a negative affect on quality of life. Although saphenous nerve injury is common after full-length stripping of the GSV, it may not be clinically significant [23]. If stripping of the GSV well below the knee is avoided, the incidence of saphenous vein injury will be reduced. Groin-to-ankle stripping was popular during the turn of the century because it was believed that reflux was uniformly distributed along the entire length of the GSV. However, modern duplex ultrasound has proven that the goal of saphenous vein stripping, T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1403 eliminating the gravitational reflux, is well-affected by detaching the GSV from perforating veins in the thigh only. This finding makes stripping of the GSV to well below the knee level or ankle unnecessary in most cases. Minimally invasive techniques Dissection of the SFJ can be technically difficult, especially in overweight patients. This dissection can be associated with persistent lymphatic leak, prolonged wound healing, and wound infection. Open dissection in this area also places the common femoral artery and vein at risk for injury. The two new minimally invasive techniques discussed below avoid a groin incision and surgical exposure of the SFJ. Because dissection of the SFJ is eliminated, neovascularization with the future potential for varicose vein recurrence can be theoretically reduced [16,17]. Technically, these procedures can be easier to perform, especially in obese patients. Because no incision is made in the groin, essentially all complications and pain related to this part of the procedure are eliminated. These minimally invasive procedures require an initial capital investment for equipment. Plus, there will be acquisition of new disposable items that are specific to each technique. Duplex ultrasound is also required in the procedure room to identify anatomy and assist with infiltration of tumescent anesthetic. Correct identification of the SFJ with duplex ultrasound is essential. This requires imaging skills and detailed knowledge of venous anatomy by the surgeon. Radiofrequency ablation The technique evolved from an initial effort to produce a competent venous valve by radiofrequency (RF) heat contracture of collagen in the vein wall at the base of a valve [24]. This began with animal experiments in the VNUS Medical Technologies Lab (San Jose, California) in 1996. Although the procedure was not reliable for producing a competent valve, the studies did demonstrate the feasibility of decreasing the treated vein diameter to a small lumen that was only 1 to 2 mm [24]. This effectively led to vessel occlusion after formation of a thrombus plug within the newly reduced vein lumen. Human trials began in 1998 in Europe, with Federal Drug Administration approval of the technique in the United States in 1999. The Closure procedure (VNUS Medical Technologies, Inc., San Jose, California) is a novel endovascular computer feedback-controlled application of bipolar electrothermal energy that ensures transmural heating of the treated vein wall while minimizing thermal spread to neighboring tissues [25]. In most cases, the greater or LSV can be accessed in a percutaneous fashion with cutdown reserved for the difficult to access vein. This is a catheter-based procedure in which the saphenous vein is ablated from within by resistive heating [25]. Bipolar delivery of RF energy directly to the 1404 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 vein wall causes resistive heating that results in total loss of vessel wall architecture, disintegration, and carbonization [26,27]. The device provides continuous impedance and vein wall temperature feedback to a computer generator that allows the operator to vary catheter pullback speed to ensure effective RFA of the vein [25]. Numerous studies have demonstrated that the Closure procedure is an effective surrogate for surgical stripping. The VNUS system has two main components. The catheter is a sterile single-use disposable device with sheathable electrodes and a thermocouple at the tip. The catheter comes in two sizes—6 Fr and 8 Fr—and the tip provides continuous temperature feedback to the RF generator [25]. Each catheter also has a central lumen that facilitates through-catheter cannulation with a 0.025 guidewire. This feature is handy for the occasional case in which the catheter does not easily pass from the insertion site to the SFJ. The 6-Fr catheter has four fanned electrodes that can expand from 2 mm to 8 mm in diameter, and the 8-Fr catheter has six paired electrodes with an expansion range between 4 mm and 12 mm [25]. The electrodes are designed to engage the intima of the vein wall at the range of diameters of each catheter. Once the electrodes engage the intima, controlled resistive heating causes shortening and thickening of the collagen fibrils as the catheter is slowly withdrawn from its insertion site [25]. This process ultimately leads to permanent closure of the treated vein. When the RF generator temperature is set to 85(C catheter pullback speed should be $2.5 cm/min. However, if the temperature is set at 90(C, the pullback speed can increase to 4.0 cm/ min, which significantly decreases treatment time. In general, treatment time ranges between 12 and 16 minutes for closure of the GSV from the SFJ to the proximal leg level. In vitro RFA studies show histologically circumferential loss of endothelial cells associated with degeneration of collagen and necrosis of muscle fibers [25]. Factors that effect this process include temperature, which depends on blood flow, and electrode contact with the vein wall, which depends on vein diameter and appropriate vessel exsanguination. Impedance and duration of treatment will also effect treatment. Effective resistive heat results from the flow of energy through the relatively higher impedance vein wall. Pullback speed that is too fast will be ineffective, and if it is too slow, thrombus buildup on the thermocouple tip will cause catheter malfunction. The second component of the Closure system is the RF generator. This compact unit recognizes each catheter and selects the appropriate algorithm to effect vein closure [25]. The generator has a test button that confirms electrode contact with the vein wall. For instance, ‘‘test’’ numbers would be lower that expected (‘‘normal’’ at the SFJ for the 6-Fr catheter is [200 ohms, 8 Fr[150 ohms) if the catheter was in the large caliber common femoral vein. These might approximate that seen when the electrodes are opened in saline (100–150 ohms for the 6-Fr catheter and 40–70 ohms for the 8-Fr catheter). During actual treatment, ohms will be [150 with the 6-Fr catheter and above T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1405 100 with the 8-Fr catheter. The RF generator maintains the set temperature with as little wattage as is possible, and this is capped at 6 watts [25]. If the temperature or impedance exceed limits set within each catheter’s algorithm, the operator is notified with a displayed error message on the generator. If the condition continues, the RF generator will automatically switch off. Common conditions that disrupt the algorithms include poor vein wall contact by catheter electrodes or thrombus/coagulum at the thermocouple tip [25]. The mechanics of the surgical procedure are relatively straightforward with a few caveats. The treated vein should be relatively straight, free of severe tortuosity or thrombus, and without aneurysm. Contraindications include a postphlebitic vein that cannot be accessed, a mega-saphenous vein (>12 mm) and significant dilation of the proximal saphenous vein with an ‘‘aneurysmal’’ SFJ [28]. The procedure is greatly enhanced by preoperative ultrasound-guided marking of the entire length of the vein to be treated. This facilitates vein cannulation and infiltration of tumescent anesthetic. Table position should change from reverse Trendelenburg, to dilate the vein as the catheter is passed toward the SFJ, to Trendelenburg to empty the vein during treatment. If there is any question about the location of the catheter in relation to the SFJ it would be better to abandon RFA versus potentially injuring the common femoral vein or applying RF energy to surrounding tissue outside the vein wall. Finally, it is wise to clearly document reflux in the saphenous vein otherwise reimbursement for the procedure may be denied by the insurance carrier. The following briefly describes the details of the procedure, which we prefer to perform under light general anesthesia in our outpatient surgery suite. The entire lower extremity should be prepped and draped to allow hip abduction and knee flexion within a sterile field. A 5-MHz duplex ultrasound probe covered with transmission gel is then placed within a sterile sheath and introduced into the field. Using duplex ultrasound, the saphenous vein is cannulated at the midleg level with a micropuncture set. Vein cannulation is facilitated by application of a tourniquet above the knee and the patient in reverse Trendelenburg position. Following guidewire and catheter exchange, a 6-Fr or 8-Fr Closure sheath can be advanced over the wire into the saphenous vein. A pressurized infusion of heparinized saline should be established through the central lumen of the Closure catheter before insertion into the sheath. This helps to prevent thrombus formation on the thermocouple tip and electrodes. The radiofrequency Closure catheter (6 or 8 Fr) is then introduced into the sheath and passed proximally to place its tip 1 cm inferior to the SFJ. This position will be seen by duplex ultrasound as just inferior to the superficial epigastric vein (SEV). Some studies have suggested that the remaining patency of the SEV reduces risk of thermal injury to the common femoral vein [24]. An over-the-wire technique using a long 0.025 guidewire can be used at this juncture for the occasional need to traverse challenging saphenous vein anatomy. 1406 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 The catheter position is confirmed by duplex ultrasound imaging and then the course of the GSV from the SFJ to $10 cm below the knee is anesthetized by tumescent infiltration of 1% lidocaine with epinephrine. Duplex ultrasound is essential for this part of the procedure, as the tumescent anesthetic is more effective if the delivery needle (20-gauge spinal needle) pierces the fascia that envelopes the saphenous vein. Infiltration of fluid within (or even above) the enveloping vein fascia will quickly increase the distance between the vein and the skin. This distance should be !1 cm to provide a ‘‘heat sink’’ that reduces the risk of thermal injury to adjacent saphenous nerve and skin [24]. Tumescent anesthesia also contributes to vein spasm, which helps to eliminate blood flow within the treated vein [24]. The patient should now be placed in the Trendelenburg position and a final catheter position check should be made at the SFJ. Temperature and impedance results of the ‘‘test’’ button on the generator should now be appropriate for the chosen catheter. The RF generator can then be activated, and after the electrodes have heated slow withdrawal of the catheter can proceed at a rate of approximately 4.0 cm/min. This should be monitored to keep the vein-wall temperature within 90 Æ 3(C, and the generator output well below its 6-watt maximum power. Note that the default temperature setting on the generator is 85(C, and at this level pullback speed should be 2 to 3 cm/min (we have been advised by VNUS that pullback speed/temperature can increase as described with no change in outcome). The vein is usually treated to the proximal calf or knee crease. After treatment, the catheter and cannula are withdrawn from the saphenous vein and hemostasis established with direct pressure. Repeat duplex imaging is a bit cumbersome at this stage due to the tumescent anesthetic and vein spasm. However, it usually shows no flow over the entire length of treated GSV. After assuring hemostasis, the skin incision over the saphenous vein is closed with a Steri-Strip. Steri-Strip closure is also performed at the site of each stab incision, and the extremity is dressed with gauze pads and an elastic wrap from the base of the toes to the groin. An appropriately treated vein wall appears edematous when initially imaged with duplex ultrasound [24]. Imaging studies done early after the Closure procedure have shown vein wall shrinkage ranging from 65 to 77% [24]. In addition, there may be a minimal amount of color flow present through a small flow channel, but the vein usually thromboses completely shortly thereafter [24]. This is due to the fact that intense wall shrinkage leaves a 1- to 2-mm central vein lumen that quickly develops a thrombus plug [24]. It is wise to rescan the SFJ and treated vein within 72 hours of treatment to ensure that none of the saphenous vein thrombus has propagated into the femoral vein. If the early postoperative duplex scan shows a thrombosed vein and no thrombus in the femoral vein there is little to be gained by repeat scanning. However, imaging studies have demonstrated progressive vein contraction until the vein actually disappears as T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1407 a definable ultrasound structure [24]. At 12 months, over 85% of treated veins are no longer detectable with duplex ultrasound [24]. There is growing clinical evidence indicating that RFA of the saphenous vein is beneficial [27–35]. Registry recording of Closure results contribute additional supporting data [28,31]. At 1- to 2-year follow-up, reported results from ablation of the saphenous vein are as good or better as those from conventional surgical treatment. Imaging studies show that the treated saphenous vein disappears as a defined ultrasonographic object after the 2-year point [34]. Advantages of the procedure include the fact that there are no surgical wounds requiring suture closure, and there is minimal to no postoperative pain. Clinical observations suggest that patients are much more comfortable in the early postoperative period and experience quicker recovery after saphenous vein ablation compared with surgical stripping [27–31,33–37]. One study that compared VNUS Closure to stripping noted that there was also a cost saving for employed patients after Closure because sick leave was shorter and physical function was restored quicker [33]. Merchant et al [28] demonstrated that the procedure is a viable alternative to saphenous stripping in a multicenter study with 2-year follow-up. At 24 months, 85% of treated veins were closed, 3.5% were near-completely closed, and only 11.5% had some areas of recanalization. Ninety percent of limbs were free of saphenous reflux at 24 months, and overall patient satisfaction was achieved in 94%. There was a 5.6% incidence of paresthesias at latest follow-up and the early small incidence (6 of 143 limbs) of thermal skin injury was eliminated (0 of 143 limbs) later by improvement in tumescent anesthetic technique. The deep venous thrombosis (DVT) rate was 1% (3 of 286 limbs), with one pulmonary embolus treated successfully by heparin anticoagulation. In their discussion, the authors point out a few potential problems that could occur with the Closure procedure [28]. These include common femoral vein thrombosis, recanalization of the saphenous vein, recurrent reflux due to the fact that there is incomplete tributary disconnect at the SFJ, paresthesias/neuritis, and persistence of reflux in a duplicated saphenous vein. Fortunately, DVT is reported as rare (1%), and in most cases well treated by anticoagulation alone. Extensive recanalization should also be an unusual occurrence. There was one in 300 cases reported in the Straub series and \5% in other reported series [27–31,33–37]. The authors also comment that patency or even reflux in the proximal 5 cm of the saphenous vein appears to be well tolerated at midterm follow-up. Chandler et al [29] reported on 273 patients/300 limbs from 25 study sites in Europe, the United States, and Austria. Almost all the cases (95%) involved treatment of the GSV through the thigh (72%) or to the ankle (23%). High ligation was used as an adjunct in 21% of these cases and stab avulsion of varicose veins was performed with RFA in 60% of treated limbs. Although mean follow-up was only 5 months, 1-year follow-up was available for 191 limbs in 173 patients. The rate of recanalization of 1408 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 a saphenous segment !5 cm was 7.2% but only 3.8% of limbs had Doppler detectable reflux. At latest follow-up there was a significant and persistent improvement in CEAP classification with 90% of limbs free of objective signs of venous disease. In the Chandler series complications were listed in terms of phlebitis, paresthesias, thermal skin injury, and DVT [29]. Clinically symptomatic phlebitis occurred in 20 of 300 limbs (6.7%). The incidence of heat-induced paresthesias was 19% (58 of 300), and this was more common when the GSV was treated distal to the proximal calf. In fact, significant paresthesias occurred in 28% of cases that carried treatment to the ankle. Thermal skin injury was noted in 2.7% of cases (8 of 300), and this rate increased when the LSV was treated. The femoral vein DVT rate was 1.4% (3 of 223), and this figure excludes the high ligation cases. Another clinical series demonstrated closure of 97% of treated veins (280 of 288) within 1 week of surgery, and at 6 months 95% of treated limbs were free of reflux [30]. Leg pain was reported in only eight limbs (8.6%) at 6month follow-up. Leg fatigue, which was reported to be present in 68% of limbs before Closure, was reduced to only 3.2% after RFA of the saphenous vein. Complications included DVT (1%), thermal skin injury (2.8%), and clinically significant phlebitis (3.1%). The initial incidence of paresthesias (13.6%) decreased to 5.7% at latest follow-up. A worldwide, multicenter patient registry was established in 1998, and a publication in 2001 reported on 12-month follow-up [31]. No cases were included in the registry if the patient had adjunctive high ligation of the GSV. Three hundred twenty-four limbs were eligible for study, except that 12-month data was only submitted for 235 limbs (72.5%). The following results are described for these 235 patients. The GSV was treated through the thigh in 181, through the proximal calf in 8, and through the ankle in 41 cases. The LSV was treated in four cases and one patient in the registry had an accessory vein treated. Phlebectomy accompanied 63% of cases, while 7% had adjunctive sclerotherapy. At 12 months, the vein occlusion rate was 86.8% (204 of 235) [31]. Ninety-one percent of limbs (212 of 233) were free of varicose veins, and 90.2% (212 of 235) were free of reflux by duplex ultrasound imaging. There was a significant improvement in CEAP clinical classification. Adverse events that persisted at 12-month follow-up included scarring from thermal injury in two limbs (0.8%) and residual pigmentation along the treated GSV in two limbs (0.8%). Seven limbs (3.0%) had paresthesias, and this rate was increased when the GSV was treated past the proximal calf level. Weiss and Weiss reported on the treatment of 140 GSVs in 120 patients [32]. After RFA patients were evaluated clinically and by duplex ultrasound at 1 week, 6 weeks, 6 months, 12 months, and 24 months. Vein occlusion was successfully achieved in 137 of 140 (98%) at 1 week. Five patients had some flow in the GSV at 6 weeks, and three were recanalized at 6 months. Leg pain was present before RFA in 85% of patients. After RFA this pain T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1409 incidence was reduced to 7% at 6 weeks and further decreased to 4% at 6 months. There were no instances of DVT or thrombus extension into the CFV, nor were there any thermal injuries or clinically significant instances of phlebitis. The paresthesia rate of 8.6% at 1 week was only 1.0% at 6 months. At 6-month follow-up, 98% of patients said they would recommend the procedure to a friend. Finally, a prospective randomized multicenter study comparing RFA to ligation and surgical stripping was recently published in the Journal of Vascular Surgery [35]. The EVOLVeS study compared procedure complications, patient recovery and quality of life in 45 RFA limbs, and 36 ligation and surgical stripping limbs. The groups were similar in terms of demographics, CEAP classification, and clinical severity of venous disease. Procedural complications were few in each group. There was one perioperative hematoma in each group. One vein perforation occurred in the RFA group and two vein tears occurred in the ligation and stripping group. Immediate success on the day of treatment was noted in 95% of the RFA group and 100% of the ligation and stripping group. The failures in the RFA group were due to the inability to pass the catheter through the GSV to the SFJ in one case and indeterminate vein contracture in another case in which a 5-Fr catheter was used in a large vein. Time to return to normal activity was significantly shorter in the RFA group (mean of 1.15 days compared with 3.89 days). Note that 80.5% of RFA patients returned to routine activities with 1 day of surgery compared with 46.9% of ligation and stripping patients (P \ 0.01). RFA patients returned to work 4.7 days (mean) after surgery compared with a mean of 12.4 days in the other group. Absence of all complications or adverse postoperative findings consistently favored the RFA group through the 3-week follow-up period, but the groups were similar in this regard by 4 months after surgery. Regarding perioperative tenderness, ecchymosis, and hematoma, RFA was better. There were no instances of DVT, pulmonary embolus, thermal skin injury, or lymphatic complications in either group. In the RFA group, 84% of treated veins were thromboses by 72 hours after surgery [35]. Three others closed within 3 weeks of surgery, and 9.5% of treated veins remained open. These cases were considered to be technically incomplete; however, all these limbs were asymptomatic at 4-month follow-up. Clinical assessment of cosmetic result and overall pain was better in the RFA group. Finally, quality of life assessment favored the RFA group from 1 to 3 weeks after surgery, but this difference was negligible at 4 months. Registry data and these clinical studies clearly demonstrate that obliteration of the saphenous vein, the specific goal of endoluminal treatment of venous reflux, is positively affected by the VNUS Closure technique. Follow-up at 3 years shows that RFA accomplishes this objective. Laser light energy has also been used to achieve this goal in place of RF energy, but its efficacy has not yet been proven in large clinical trials. One final issue 1410 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 that remains unsettled at present is whether there will be varicose vein recurrence after saphenous vein obliteration without SFJ venous tributary disconnection. Some authors have suggested that the Closure procedure prevents subsequent neovascularization in the groin, and there are some centers that have reported no neovascularization in the absence of a groin incision [27]. Endovenous laser therapy (EVLT) The endovenous laser is currently approved by the US Food and Drug Administration for the treatment of GSV reflux [38–41]. Wavelength laser energy (810-nm) is delivered via a 600-lm fiber. The laser causes the blood to boil, which results in steam bubbles [40]. This causes collagen contraction and endothelial damage. The result is thickening of the vein wall and contraction or thrombosis of the lumen. The use of diode laser energy to ablate the saphenous vein is a method that obviates the need for general anesthesia, and is associated with less pain than traditional surgical stripping of the GSV. This procedure can be performed in an office-based setting using local anesthesia following preoperative assessment with duplex ultrasound. Similar to RFA, it is important to identify abnormalities of the GSV with duplex, as well as to accurately determine vein diameter. Ultrasound guidance is used to access the GSV at the level of the knee. A 0.035-inch j-tipped guide wire is then introduced into the vein and passed to the level of the proximal saphenous vein. A 5-Fr introducer sheath (Cook, Bloomington, Indiana) is then inserted into the vein. The sheath should be of appropriate length to match the length of the treated GSV. Position of the sheath at the SFJ is confirmed with ultrasound and nonpulsatile blood withdrawal. A sterile bare tipped 600-lm diameter, 810-nm laser fiber (Diomed, Andover, Massachusetts) is then positioned 1 to 2 cm below the SFJ. Confirmation of the position of the laser tip is done using both duplex ultrasound and visualizing the red aiming beam through the skin. The tissue surrounding the GSV is then infiltrated with tumescent anesthetic. The vein is compressed manually to oppose the vein walls and aid in the obliteration of the lumen. The laser is then slowly withdrawn with subsequent obliteration of the GSV. Postoperatively, compression stockings are worn for 1 week. Patients are allowed to resume normal activities after the procedure. The short-term results of EVLT are reported as excellent. One clinical study demonstrated that at 1 week 87 of 90 (97%) laser treated GSVs were occluded [38]. At 6-month mean follow-up 99% remain closed. The complications with this therapy were reported as minimal [38]. Ecchymosis and mild discomfort can be expected. Few (5 of 90) patients had pain that lasted longer than 1 week and required nonsteroidal analgesics. Only one patient developed paresthesias over the medial calf [38]. These encouraging T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1411 results have been reproduced by other authors. Proebstle et al [39] treated 29 patients with a 97% rate of GSV occlusion at 1 month. Min et al [40] assessed their mid- and long-term results of EVLT. They evaluated 423 patients who had 499 GSVs treated with laser over a 3-year period. Patients were evaluated clinically and with duplex ultrasound at 1 week, 1 month, 3 months, 6 months, 1 year, and yearly thereafter to assess treatment efficacy and complications. Successful treatment of the GSV, defined as absence of flow with color Doppler imaging, was noted in 490 of 499 (98.2%) GSVs after initial treatment and at 9-month follow-up 351 of 359 (97.8%) GSVs remained closed. At 2-year follow-up, 113 of 121 (93.4%) GSVs were thrombosed. Of note, all treatment failures occurred before 9 months, with the majority noted before 3 months. Bruising was present in 24% of patients at 1 week follow-up; however, this had resolved in all patients by 1 month. Five patients developed superficial phlebitis in varicose tributaries after treatment. Most patients had resolution of their symptoms and improvement in the severity of varicose veins. EVLT appears to be a viable option in the treatment of saphenous vein reflux. The modality is safe with acceptable midterm results. ELVT has the advantage of less expensive disposable items, therefore with a lower cost procedure. This minimally invasive procedure along with RF ablation has produced excellent cosmetic results with few recurrent problems. Although both procedures appear to be effective methods of eliminating saphenous vein reflux, long-term data are necessary before either procedure can be considered as the new standard. Treatment of symptomatic varicose veins Stab avulsion Resection of varicose veins by any method requires accurate preoperative marking of the areas to be treated. Varicosities are best identified by inspection and palpation with the patient standing. These are then marked with a surgical pen before the patient enters the operative suite. Careful prepping of the skin is then necessary to avoid removal of the marks. The technique of stab avulsion phlebectomy was introduced by Dr. Robert Muller in 1966 [41]. The original procedure, which was modified by use of sterile technique, is widely practiced, and should be considered the gold standard for removal of varicose veins [42]. Stab avulsions can be performed through many small incisions. The incisions are made using an ophthalmic knife or a #11 blade. The incisions do not need to be any larger than 1 to 2 mm; however, they must be deep enough to cut through the dermis. A Muller hook is then used to blindly grasp the adventitia of the varicose veins. Once a portion of the vein is pulled out of the skin incision a hemostat clamp can be used to secure the 1412 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 vein. The vein is then divided and carefully resected in both directions. Gentle traction on the vein with sequential mosquito hemostat application ensures that a lengthy segment of vein is pulled out from each incision. Formal vein ligations are unnecessary, as they close in spasm after retracting from the skin incision. This method can be repeated over the course of the varicosities keeping the incisions as far apart as possible. Improved hemostasis can be obtained with leg elevation and direct external pressure. The skin incisions are closed with tape strips, and the lower extremity is wrapped from foot to proximal thigh with compressive gauze and an elastic wrap to minimized hematoma formation [21]. Transilluminated power phlebectomy (TIPP) The TrivexTM System (Smith & Nephew Andover, Massachusetts) uses a light source beneath the skin for varicose vein visualization and a powered suction resector to perform the phlebectomy [43–45]. The concept of TIPP is to improve excision accuracy with direct visualization of the varicose veins and to decrease operative time with the specialized resector. The procedure is performed with two devices. The transilluminator consists of a light from a 45-degree illuminator connected to a 300-watt light source. There is a port on the transilluminator for the instillation of tumescent anesthesia. The resector is a rotating blade protected by an outer sheath with suction attached to it. The blade rotates at various speeds in a forward, reverse or oscillating manner. The varicosities are aspirated, morcellated and then removed by suction. The procedure is operator dependent, and there is a definite learning curve necessary to achieve good results. It begins with two 2- to 3-mm incisions made at the circumference of the area of varicose vein clusters. A transilluminator is inserted below the dermis and tumescent anesthesia is infiltrated. This is used to hydrodissect the veins for subsequent excision and to create a larger area of transillumination. Although the veins are visualized using the transilluminator, the resector is inserted opposite the light source. For simple varicose veins the resector is set at 500 rpm with suction on high. Movement of the resector is controlled to minimize tissue damage and the subsequent development of hematomas. After the veins are resected the area is infiltrated with more tumescent anesthesia to obtain hemostasis and remove all the subcutaneous blood. A dermal punch can be used to allow drainage of blood and excess tumescent anesthesia. A final stage of tumescent anesthesia is then performed using an 18-gauge spinal needle. Again, it is very important to remove all blood from within the tissues to minimize postoperative pain and hematoma. The lower extremity is then wrapped with a compression dressing. Neither the incisions nor the dermal punches need to be closed. In 2000, Spitz et al [43] demonstrated that TIPP is a safe, effective, and cosmetically acceptable procedure. A larger multicenter study involving 117 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1413 limbs, performed in Europe and the United States confirmed that the procedure could be performed safely with satisfactory results for the patient [44]. Patients did suffer significant ecchymosis; however, by 6 weeks this had resolved in all patients. Saphenous nerve injury was observed in 41 patients; however, it is unclear whether this was a result of TIPP or the GSV stripping that was performed at the same time. Two serious adverse outcomes were reported. There was one DVT and a single death 29 days after the procedure, presumable from a myocardial infarction. This study reported that the benefit of TIPP for removal of varicose veins was a decreased number of incisions (mean 3.5) and operating time (mean 14 minutes for TIPP, range 3 to 75 minutes). Shamiyeh et al [45] demonstrated patient satisfaction in the majority of patients. They also demonstrated the procedure to be safe and effective; however, two patients of 30 required reoperation for hematoma evacuation. Aremu et al [46] evaluated TIPP in a prospective randomized trial comparing this procedure with conventional phlebectomy. They randomized 188 limbs in 141 patients to conventional phlebectomy versus TIPP. Patients who underwent TIPP required fewer incisions. There was no difference in pain, cosmesis, or satisfaction at any time period during followup. There was a trend toward lower operating time in the TIPP group; however, this was not statistically significant. The authors commented that with experience the operator could reduce operative time and the incidence of postoperative hematomas. However, they also emphasized the fact that there is a learning curve with the TIPP procedure. Foam sclerotherapy Agents that damage the venous endothelium and subsequently cause obliteration of the vein lumen are not a novel concept. Sclerotherapy is highly effective in the treatment of small varicose veins and reticular veins. However, standard sclerotherapy has been disappointing in the treatment of large superficial veins. This is likely due to inadequate sclerosant injected in the GSV or LSV, for fear that the sclerosant will reach the deep system and cause complications. Orbach introduced the concept of sclerotherapy using an intravenous air block a half-century ago [47]. Using foam sclerotherapy the dilution of the sclerosant with blood in larger veins is reduced. An air block is formed that halts blood flow in the vein. The surface area of the sclerosant is larger, and therefore the agents are more effective. Foam sclerotherapy is gaining acceptance is Europe, and several new sclerosing agents are being developed. At the present time there are no foam sclerosants commercially available. However, foam sclerotherapy can be performed by mixing currently approved sclerotherapy agents with air to create microfoam. Patients must have no contraindications to sclerotherapy. Ultrasound guidance is used to identify the saphenous vein. Local anesthesia in the skin at 1414 T.H. Teruya, J.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 the site of injection can be used to decrease pain. The saphenous vein is then injected with the foamed sclerosant. External compression at the SFJ can prevent entry of the agent into the deep venous system. Compression dressings are then placed. The procedure is associated with very little discomfort, and can be performed on an ambulatory basis. Minor complications of the procedure are reported to be pigmentation and superficial thrombophlebitis. However, more serious complications can include anaphylaxis and intraarterial injection [47–50]. Cabrera et al [48] demonstrated that foam sclerotherapy was effective in treating varicose veins with saphenous reflux in 86% of patients. Single treatment of foam sclerotherapy using ultrasound guidance was effective in obliterating the GSV in 81% of cases. This treatment was effective in eliminating varicose veins in 96% of cases. Retreatment was necessary in only a few cases. Other authors have also demonstrated excellent long-term results in the treatment of greater and LSV reflux using this technique. In one study, elimination of reflux was noted in virtually all patients at 3, 6, and 12 months follow-up [49]. The VEDICO trial compared the treatment of varicose veins using several techniques including sclerotherapy, surgery, and foam sclerotherapy [50]. This trial demonstrated that foam sclerotherapy was as effective as surgery in the treatment of varicose veins [50]. Foam sclerotherapy holds great potential. Expensive equipment required to perform RF ablation, EVLT, and TIPP are unnecessary for foam sclerotherapy. Minimal anesthesia is required and the procedure can be office-based in essentially all practices. The procedure is relatively simple to perform, and will become a useful extension to standard sclerotherapy. Summary New, minimally invasive techniques for the treatment of varicose veins including RFA, EVLT, and TIPP represent effective and possibly superior alternatives to traditional saphenous vein stripping and stab avulsion of varicose veins. Further experience with these procedures will help to determine which ones will become the method of choice for treating this complex disease process. Some of these new techniques may not prove to be effective in the hands of all treating specialists. However, it is very likely that some of these techniques, such as foam sclerotherapy, will replace the procedures that we currently use today. References [1] Fegan WG, Lambe R, Henry M. 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