Surg Clin N Am 84 (2004) 1397–1417New 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 . 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 . 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 . 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 . Preoperative evaluation History and physical examination are very important in the evaluation of patients with venous disease. Risk factors associated with varicose veins Patients with large varicose veins or patients with skin changes should be oﬀered treatment speciﬁcally designed to avoid future ulceration. If symptoms are not consistent with varicose veins. and perforating venous systems.H. A careful physical examination should be done to determine the nature. female gender. Washington). and lipodermatosclerosis.L.T.to 7. and location of varicose veins. Initial evaluation of the venous system is performed to determine the presence or absence of obstruction in the deep or superﬁcial venous system. and pathophysiology of segmental venous reﬂux. 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. multiple pregnancies. Duplex interrogation of various portions of the superﬁcial and deep venous systems is then performed with rapid cuﬀ inﬂation and subsequent deﬂation. Formal noninvasive imaging of the venous system with duplex ultrasound will conﬁrm the etiology. . The question that will eventually arise will be whether or not the varicose veins are simply a cosmetic issue. the hand-held Doppler probe was an essential adjunct to the physical examination. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1399 include increasing age. hyperpigmentation. with treatment speciﬁcally aimed at varicosities. noninvasive. and family history [5–7]. the musculoskeletal system should be brieﬂy assessed to determine if there is a rheumatologic or orthopedic problem responsible for the lower extremity pain complaints. a chronic activity that involves prolonged standing. A past history of superﬁcial thrombophlebitis or deep-venous thrombosis is important for prognosis. The presence of edema and skin changes should also be noted. deep. These skin changes include eczema. or congenital arteriovenous malformations. Bothell. It is critical to determine the level of disability that the patient associates with their varicose veins. Quality results may also be undermined by signiﬁcant deep venous reﬂux. Thigh and calf cuﬀs that rapidly inﬂate and deﬂate are essential components of the examination (Hokansen. extent. Finally. Teruya. anatomy. When there are perceived as symptomatic. Before the widespread use of duplex ultrasound in the evaluation of patients with chronic venous insuﬃciency (CVI). this observation should be diﬀerentiated into a minor annoyance or a lifestyle-limiting problem. The examination uses a high-resolution duplex ultrasound machine with pulsed and color Doppler using a 5. patients with varicose veins will associate other musculoskeletal symptoms with their varicose veins. and surgical expectations will need to be tempered. then there is a low likelihood of relief. Peripheral arterial disease should be ruled out as a cause of the patient’s symptoms. It is also important to determine if there are other etiologies causing the patient’s symptoms . Occasionally. history of phlebitis. history of ulceration.5-MHz transducer probe. Modern duplex ultrasound has made most other clinical tests for venous disease unnecessary. J. This test is a safe. and cost-eﬀective method of determining reﬂux in the superﬁcial. Teruya.10].1400 T. varicose vein recurrence is not solely the result of an inadequate surgical procedure. Varicose veins can be treated with stab avulsions and transilluminated powered phlebectomy. Another possible cause of recurrent varicose veins is neovascularization at the SFJ from dissection in this area [16. In most cases. 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]. Treatment failure can be a result of inadequate removal or ablation the reﬂuxing saphenous vein. Even successful surgery will not negate a genetic tendency to develop varicosities from vein wall weakness [14. essentially risk free. and endovenous laser ablation. Complete treatment of clinically symptomatic varicose veins must therefore involve treatment of the saphenous vein reﬂux as well as the varicosities.H. or insuﬃcient ligation/ablation of venous tributaries at the SFJ. The diagnosis of reﬂux will be made if there is reversal of ﬂow for longer than 0. compression stockings are unlikely to be accepted as primary therapy. J. For patients who consider varicose veins to be unsightly.17]. The underlying cause of venous hypertension must be addressed or recurrence of the varicosities can be expected. Thus. they deﬁnitely seem to reduce leg edema. missing a duplicated venous system.15]. This form of therapy is relatively inexpensive. recurrence of varicose veins is often related to inadequate initial treatment of reﬂux in the GSV or lesser saphenous vein (LSV). It is unclear exactly how compression stockings improve symptoms.L. Patient compliance is the major factor causing failure of compression therapy. radiofrequency ablation (RFA). Finally. Current strategies designed to eliminate reﬂux within the saphenous vein include surgical stripping. and may decrease the pressure that is distributed to somatic nerves by venous reﬂux. foam sclero- .5 seconds after cuﬀ deﬂation [9. However. Recurrence may be due to persistent venous hypertension from sources other than the treated saphenous vein. 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. Conservative management Graduated compression stockings remain the ﬁrst line therapy for patients with primary venous disease. In some cases. 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. saphenous vein reﬂux is the underlying primary problem. and can be eﬀective in improving symptoms related to superﬁcial venous reﬂux and varicose veins. 20]. The short stump of remaining saphenous vein should be oversewn with prolene suture ﬂush with the femoral vein. high ligation without saphenous vein stripping fails to eliminate axial reﬂux in most patients.19.H. Tributary veins about the SFJ should be dissected well into the periphery before they are ligated and divided. 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 addressing all venous tributaries that are emanating from the SFJ. and in most cases there is little diﬃculty passing it in this direction. Excellent results were achieved in most patients who had GSV stripping (94%) compared with only 40% of the patients who underwent high ligation alone. Until recently. In some severe forms of CVI this may be accompanied by removal of the hydrodynamic forces of perforator vein outward ﬂow. 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. and will be described below for the GSV.’’ and oﬀered the advantage of decreased bleeding and pain and a lower incidence of wound infection. After all the obvious tributary veins are ligated. This is due to the fact that a reﬂuxing . J. Unfortunately. This procedure also had the theoretical advantage of preserving the GSV for later use as a conduit for arterial or coronary bypass procedures. High ligation alone was considered a ‘‘simple ﬁx. It is not appropriate as the primary procedure of choice for the treatment of superﬁcial venous reﬂux. Teruya. The technique of saphenous vein stripping is relatively simple. If the tributaries are large. An oblique incision is made cephalad to the groin crease just medial to the femoral artery pulse. 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. the saphenous vein can be disconnected from the junction after application of a vascular clamp on the femoral vein. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1401 therapy holds promise for treatment of saphenous vein reﬂux and varicose veins. In a classic study by Lofgren and Lofgren at the Mayo Clinic. Therefore. high ligation of the saphenous vein should be reserved for special circumstances only.T. This has been conﬁrmed by several prospective studies [12.13. GSV stripping was associated with better immediate results and a decrease in the long-term varicose vein recurrence rate . high ligation of the GSV was compared with groin to ankle stripping . the SFJ (or SPJ) is identiﬁed and this area should be closely inspected for additional tributaries. A stripper is then passed distally into the GSV.L. One drawback to saphenous vein stripping is the complication of saphenous nerve injury. 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 incidence of saphenous vein injury will be reduced. a recent study demonstrated saphenous nerve deﬁcits. However. 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 stripper will pass into large anterior or posterior tributaries. Only 6. Ballard / Surg Clin N Am 84 (2004) 1397–1417 saphenous vein has few to no competent valves. in 58% of patients who had stripping to the ankle level . At the time of latest follow-up examination. it may not be clinically signiﬁcant . modern duplex ultrasound has proven that the goal of saphenous vein stripping. The saphenous vein can now be stripped from groin to proximal leg using a slow pull on the distal end of the stripper. In addition. Although saphenous nerve injury is common after full-length stripping of the GSV. If stripping of the GSV well below the knee is avoided. and as it is stripped distally will actually pull away from subcutaneous tissue and any surrounding nerve. The GSV at the groin is securely attached to the stripper with a sturdy suture ligature. on physical examination. Occasionally. J. However. 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.H. 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. The saphenous vein is then divided and ligated distal to the retrieved stripper. only one patient reported a negative aﬀect on quality of life.1402 T. Teruya. We do not use any of the end attachments that come in the stripper packaging. can be unrolled and now attached to the heavy silk ligature that followed the vein as it was stripped distally. After saphenous vein stripping. which has been soaked in lidocaine with epinephrine. 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.L. and by withdrawing and redirecting the stripper it can be passed successfully through the saphenous vein. A standard 4 Â 4 gauze sponge. only 40% of patients reported symptoms of saphenous nerve injury . 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. and the gauze also facilitates the removal of any remaining vein segments. the lower extremity is wrapped from foot to proximal thigh with compressive gauze and an elastic wrap to minimized hematoma formation . Once felt to be rare complication.7% of patients noted an aﬀect in their quality of life at any time subsequent to the surgery. Rarely the saphenous vein will avulse during the inversion stripping. The ﬁrmly attached saphenous vein will invert on itself. In most cases.T.L. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1403 eliminating the gravitational reﬂux. These minimally invasive procedures require an initial capital investment for equipment. these procedures can be easier to perform. Plus. This is a catheter-based procedure in which the saphenous vein is ablated from within by resistive heating . neovascularization with the future potential for varicose vein recurrence can be theoretically reduced [16. Because dissection of the SFJ is eliminated.H. especially in overweight patients. The Closure procedure (VNUS Medical Technologies. Bipolar delivery of RF energy directly to the . Because no incision is made in the groin. is well-aﬀected by detaching the GSV from perforating veins in the thigh only. especially in obese patients.17]. This eﬀectively led to vessel occlusion after formation of a thrombus plug within the newly reduced vein lumen. and wound infection. San Jose. Duplex ultrasound is also required in the procedure room to identify anatomy and assist with inﬁltration of tumescent anesthetic. essentially all complications and pain related to this part of the procedure are eliminated. 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 . Technically. 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 . Inc. This began with animal experiments in the VNUS Medical Technologies Lab (San Jose. This requires imaging skills and detailed knowledge of venous anatomy by the surgeon. J. Human trials began in 1998 in Europe. with Federal Drug Administration approval of the technique in the United States in 1999. the greater or LSV can be accessed in a percutaneous fashion with cutdown reserved for the diﬃcult to access vein. 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 . California) in 1996. This dissection can be associated with persistent lymphatic leak. Open dissection in this area also places the common femoral artery and vein at risk for injury. Minimally invasive techniques Dissection of the SFJ can be technically diﬃcult.. The two new minimally invasive techniques discussed below avoid a groin incision and surgical exposure of the SFJ. there will be acquisition of new disposable items that are speciﬁc to each technique. This ﬁnding makes stripping of the GSV to well below the knee level or ankle unnecessary in most cases. prolonged wound healing. Teruya. Correct identiﬁcation of the SFJ with duplex ultrasound is essential. Teruya. and electrode contact with the vein wall. which depends on blood ﬂow. ‘‘test’’ numbers would be lower that expected (‘‘normal’’ at the SFJ for the 6-Fr catheter is [200 ohms. Numerous studies have demonstrated that the Closure procedure is an eﬀective surrogate for surgical stripping. However. 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 . and the 8-Fr catheter has six paired electrodes with an expansion range between 4 mm and 12 mm . J. Ballard / Surg Clin N Am 84 (2004) 1397–1417 vein wall causes resistive heating that results in total loss of vessel wall architecture. controlled resistive heating causes shortening and thickening of the collagen ﬁbrils as the catheter is slowly withdrawn from its insertion site . The catheter is a sterile single-use disposable device with sheathable electrodes and a thermocouple at the tip. Impedance and duration of treatment will also eﬀect treatment. This compact unit recognizes each catheter and selects the appropriate algorithm to eﬀect vein closure . and carbonization [26. The generator has a test button that conﬁrms electrode contact with the vein wall. In vitro RFA studies show histologically circumferential loss of endothelial cells associated with degeneration of collagen and necrosis of muscle ﬁbers . 8 Fr[150 ohms) if the catheter was in the large caliber common femoral vein. In general. thrombus buildup on the thermocouple tip will cause catheter malfunction. disintegration. if the temperature is set at 90(C. Once the electrodes engage the intima. The VNUS system has two main components. which depends on vein diameter and appropriate vessel exsanguination. Eﬀective resistive heat results from the ﬂow of energy through the relatively higher impedance vein wall.0 cm/ min. The catheter comes in two sizes—6 Fr and 8 Fr—and the tip provides continuous temperature feedback to the RF generator . The 6-Fr catheter has four fanned electrodes that can expand from 2 mm to 8 mm in diameter. This feature is handy for the occasional case in which the catheter does not easily pass from the insertion site to the SFJ. When the RF generator temperature is set to 85(C catheter pullback speed should be $2. and if it is too slow.H. Factors that eﬀect this process include temperature. ohms will be [150 with the 6-Fr catheter and above .1404 T. During actual treatment.L. The second component of the Closure system is the RF generator.5 cm/min. For instance.27]. the pullback speed can increase to 4. Pullback speed that is too fast will be ineﬀective. 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). The electrodes are designed to engage the intima of the vein wall at the range of diameters of each catheter. Each catheter also has a central lumen that facilitates through-catheter cannulation with a 0. which signiﬁcantly decreases treatment time. This process ultimately leads to permanent closure of the treated vein.025 guidewire. treatment time ranges between 12 and 16 minutes for closure of the GSV from the SFJ to the proximal leg level. Finally. An over-the-wire technique using a long 0. Teruya. A 5-MHz duplex ultrasound probe covered with transmission gel is then placed within a sterile sheath and introduced into the ﬁeld. and without aneurysm. which we prefer to perform under light general anesthesia in our outpatient surgery suite. The treated vein should be relatively straight. The procedure is greatly enhanced by preoperative ultrasound-guided marking of the entire length of the vein to be treated. it is wise to clearly document reﬂux in the saphenous vein otherwise reimbursement for the procedure may be denied by the insurance carrier. This position will be seen by duplex ultrasound as just inferior to the superﬁcial epigastric vein (SEV). A pressurized infusion of heparinized saline should be established through the central lumen of the Closure catheter before insertion into the sheath. Common conditions that disrupt the algorithms include poor vein wall contact by catheter electrodes or thrombus/coagulum at the thermocouple tip . This helps to prevent thrombus formation on the thermocouple tip and electrodes.L. a 6-Fr or 8-Fr Closure sheath can be advanced over the wire into the saphenous vein. Vein cannulation is facilitated by application of a tourniquet above the knee and the patient in reverse Trendelenburg position. a mega-saphenous vein (>12 mm) and signiﬁcant dilation of the proximal saphenous vein with an ‘‘aneurysmal’’ SFJ . If the temperature or impedance exceed limits set within each catheter’s algorithm. the saphenous vein is cannulated at the midleg level with a micropuncture set. 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. Using duplex ultrasound. The following brieﬂy describes the details of the procedure. This facilitates vein cannulation and inﬁltration of tumescent anesthetic.H. Table position should change from reverse Trendelenburg. J. the operator is notiﬁed with a displayed error message on the generator. Following guidewire and catheter exchange. The RF generator maintains the set temperature with as little wattage as is possible. the RF generator will automatically switch oﬀ. 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. The mechanics of the surgical procedure are relatively straightforward with a few caveats. If the condition continues. and this is capped at 6 watts . Some studies have suggested that the remaining patency of the SEV reduces risk of thermal injury to the common femoral vein .T. to Trendelenburg to empty the vein during treatment. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1405 100 with the 8-Fr catheter. The entire lower extremity should be prepped and draped to allow hip abduction and knee ﬂexion within a sterile ﬁeld. free of severe tortuosity or thrombus.025 guidewire can be used at this juncture for the occasional need to traverse challenging saphenous vein anatomy. Contraindications include a postphlebitic vein that cannot be accessed. . to dilate the vein as the catheter is passed toward the SFJ. there may be a minimal amount of color ﬂow present through a small ﬂow channel. but the vein usually thromboses completely shortly thereafter . which helps to eliminate blood ﬂow within the treated vein . However. it usually shows no ﬂow over the entire length of treated GSV. After treatment. 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.to 2-mm central vein lumen that quickly develops a thrombus plug . J.1406 T. The RF generator can then be activated. An appropriately treated vein wall appears edematous when initially imaged with duplex ultrasound . Temperature and impedance results of the ‘‘test’’ button on the generator should now be appropriate for the chosen catheter. the skin incision over the saphenous vein is closed with a Steri-Strip. Repeat duplex imaging is a bit cumbersome at this stage due to the tumescent anesthetic and vein spasm. 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. 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. The patient should now be placed in the Trendelenburg position and a ﬁnal catheter position check should be made at the SFJ. Teruya.H. Imaging studies done early after the Closure procedure have shown vein wall shrinkage ranging from 65 to 77% . This is due to the fact that intense wall shrinkage leaves a 1. imaging studies have demonstrated progressive vein contraction until the vein actually disappears as . However. After assuring hemostasis. 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). Note that the default temperature setting on the generator is 85(C.0 cm/min. In addition. Duplex ultrasound is essential for this part of the procedure. The vein is usually treated to the proximal calf or knee crease. the catheter and cannula are withdrawn from the saphenous vein and hemostasis established with direct pressure.L. Tumescent anesthesia also contributes to vein spasm. and the generator output well below its 6-watt maximum power. and after the electrodes have heated slow withdrawal of the catheter can proceed at a rate of approximately 4. This should be monitored to keep the vein-wall temperature within 90 Æ 3(C. This distance should be !1 cm to provide a ‘‘heat sink’’ that reduces the risk of thermal injury to adjacent saphenous nerve and skin . 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. and the extremity is dressed with gauze pads and an elastic wrap from the base of the toes to the groin. Steri-Strip closure is also performed at the site of each stab incision. At 1. 3. Registry recording of Closure results contribute additional supporting data [28. In their discussion. 1-year follow-up was available for 191 limbs in 173 patients. At 24 months. 85% of treated veins were closed. 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 . and overall patient satisfaction was achieved in 94%. The deep venous thrombosis (DVT) rate was 1% (3 of 286 limbs).33–37]. paresthesias/neuritis. and in most cases well treated by anticoagulation alone. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1407 a deﬁnable ultrasound structure . Teruya.H. 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.31]. with one pulmonary embolus treated successfully by heparin anticoagulation.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. Although mean follow-up was only 5 months. the authors point out a few potential problems that could occur with the Closure procedure . Imaging studies show that the treated saphenous vein disappears as a deﬁned ultrasonographic object after the 2-year point . and persistence of reﬂux in a duplicated saphenous vein.5% had some areas of recanalization.5% were near-completely closed. Ninety percent of limbs were free of saphenous reﬂux at 24 months. J. and only 11.33–37]. reported results from ablation of the saphenous vein are as good or better as those from conventional surgical treatment. the United States. 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. and Austria.to 2-year follow-up. There was a 5. Extensive recanalization should also be an unusual occurrence. There is growing clinical evidence indicating that RFA of the saphenous vein is beneﬁcial [27–35]. These include common femoral vein thrombosis. recanalization of the saphenous vein.T. 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. Chandler et al  reported on 273 patients/300 limbs from 25 study sites in Europe. and there is minimal to no postoperative pain. over 85% of treated veins are no longer detectable with duplex ultrasound . At 12 months. The rate of recanalization of . Merchant et al  demonstrated that the procedure is a viable alternative to saphenous stripping in a multicenter study with 2-year follow-up. Fortunately. recurrent reﬂux due to the fact that there is incomplete tributary disconnect at the SFJ. Almost all the cases (95%) involved treatment of the GSV through the thigh (72%) or to the ankle (23%). There was one in 300 cases reported in the Straub series and \5% in other reported series [27–31. Advantages of the procedure include the fact that there are no surgical wounds requiring suture closure.L. DVT is reported as rare (1%). Clinically symptomatic phlebitis occurred in 20 of 300 limbs (6.5%). There was a signiﬁcant improvement in CEAP clinical classiﬁcation. At 12 months.2% after RFA of the saphenous vein. Leg pain was reported in only eight limbs (8. Vein occlusion was successfully achieved in 137 of 140 (98%) at 1 week.0%) had paresthesias. 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. The following results are described for these 235 patients. and clinically signiﬁcant phlebitis (3. Thermal skin injury was noted in 2. and this was more common when the GSV was treated distal to the proximal calf.7%). After RFA patients were evaluated clinically and by duplex ultrasound at 1 week. which was reported to be present in 68% of limbs before Closure. 6 months. Ninety-one percent of limbs (212 of 233) were free of varicose veins.6%) decreased to 5. Complications included DVT (1%). In fact.2% (212 of 235) were free of reﬂux by duplex ultrasound imaging. J. and at 6 months 95% of treated limbs were free of reﬂux .8% (204 of 235) .8%). and this rate was increased when the GSV was treated past the proximal calf level.7% of cases (8 of 300). Leg fatigue.H. multicenter patient registry was established in 1998. The initial incidence of paresthesias (13.4% (3 of 223). signiﬁcant paresthesias occurred in 28% of cases that carried treatment to the ankle. No cases were included in the registry if the patient had adjunctive high ligation of the GSV. was reduced to only 3. The femoral vein DVT rate was 1. and through the ankle in 41 cases. and a publication in 2001 reported on 12-month follow-up .7% at latest follow-up. Teruya. Leg pain was present before RFA in 85% of patients. The GSV was treated through the thigh in 181. the vein occlusion rate was 86.1408 T. and 90. 12 months. Ballard / Surg Clin N Am 84 (2004) 1397–1417 a saphenous segment !5 cm was 7.2% but only 3. through the proximal calf in 8.L. and DVT .1%). The incidence of heat-induced paresthesias was 19% (58 of 300). Five patients had some ﬂow in the GSV at 6 weeks. Another clinical series demonstrated closure of 97% of treated veins (280 of 288) within 1 week of surgery. Weiss and Weiss reported on the treatment of 140 GSVs in 120 patients . thermal skin injury (2. and this rate increased when the LSV was treated.8%). except that 12-month data was only submitted for 235 limbs (72. A worldwide. paresthesias. and this ﬁgure excludes the high ligation cases. 6 weeks. thermal skin injury. In the Chandler series complications were listed in terms of phlebitis. Phlebectomy accompanied 63% of cases.8% of limbs had Doppler detectable reﬂux. Three hundred twenty-four limbs were eligible for study. After RFA this pain .8%) and residual pigmentation along the treated GSV in two limbs (0. The LSV was treated in four cases and one patient in the registry had an accessory vein treated. and three were recanalized at 6 months. and 24 months. while 7% had adjunctive sclerotherapy. Seven limbs (3. Adverse events that persisted at 12-month follow-up included scarring from thermal injury in two limbs (0.6%) at 6month follow-up. Finally. or lymphatic complications in either group. In the RFA group. patient recovery and quality of life in 45 RFA limbs.L. One ﬁnal issue . ecchymosis. Regarding perioperative tenderness. Clinical assessment of cosmetic result and overall pain was better in the RFA group. nor were there any thermal injuries or clinically signiﬁcant instances of phlebitis. Absence of all complications or adverse postoperative ﬁndings consistently favored the RFA group through the 3-week follow-up period. 84% of treated veins were thromboses by 72 hours after surgery . Registry data and these clinical studies clearly demonstrate that obliteration of the saphenous vein. RFA was better. the speciﬁc goal of endoluminal treatment of venous reﬂux.6% at 1 week was only 1. but the groups were similar in this regard by 4 months after surgery. CEAP classiﬁcation.5% of RFA patients returned to routine activities with 1 day of surgery compared with 46. but its eﬃcacy has not yet been proven in large clinical trials. and 9. 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.0% at 6 months. There was one perioperative hematoma in each group. J. and hematoma. 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.15 days compared with 3. RFA patients returned to work 4.7 days (mean) after surgery compared with a mean of 12. is positively aﬀected by the VNUS Closure technique. Teruya. Procedural complications were few in each group. thermal skin injury. Three others closed within 3 weeks of surgery. and 36 ligation and surgical stripping limbs. but this diﬀerence was negligible at 4 months.01). pulmonary embolus. The paresthesia rate of 8. quality of life assessment favored the RFA group from 1 to 3 weeks after surgery. One vein perforation occurred in the RFA group and two vein tears occurred in the ligation and stripping group. The groups were similar in terms of demographics. The EVOLVeS study compared procedure complications. 98% of patients said they would recommend the procedure to a friend.89 days). Finally.5% of treated veins remained open. Follow-up at 3 years shows that RFA accomplishes this objective. At 6-month follow-up.T. These cases were considered to be technically incomplete. Note that 80. Time to return to normal activity was signiﬁcantly shorter in the RFA group (mean of 1. There were no instances of DVT. a prospective randomized multicenter study comparing RFA to ligation and surgical stripping was recently published in the Journal of Vascular Surgery . however.4 days in the other group.H. Immediate success on the day of treatment was noted in 95% of the RFA group and 100% of the ligation and stripping group. Laser light energy has also been used to achieve this goal in place of RF energy. There were no instances of DVT or thrombus extension into the CFV.9% of ligation and stripping patients (P \ 0. all these limbs were asymptomatic at 4-month follow-up. and clinical severity of venous disease. Only one patient developed paresthesias over the medial calf . A 5-Fr introducer sheath (Cook. which results in steam bubbles . Position of the sheath at the SFJ is conﬁrmed with ultrasound and nonpulsatile blood withdrawal. as well as to accurately determine vein diameter. The result is thickening of the vein wall and contraction or thrombosis of the lumen. and there are some centers that have reported no neovascularization in the absence of a groin incision . 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. A 0. and is associated with less pain than traditional surgical stripping of the GSV.L. Conﬁrmation of the position of the laser tip is done using both duplex ultrasound and visualizing the red aiming beam through the skin. A sterile bare tipped 600-lm diameter. The use of diode laser energy to ablate the saphenous vein is a method that obviates the need for general anesthesia. The laser causes the blood to boil. Some authors have suggested that the Closure procedure prevents subsequent neovascularization in the groin. it is important to identify abnormalities of the GSV with duplex. Similar to RFA. One clinical study demonstrated that at 1 week 87 of 90 (97%) laser treated GSVs were occluded . Postoperatively. The short-term results of EVLT are reported as excellent. The tissue surrounding the GSV is then inﬁltrated with tumescent anesthetic. The laser is then slowly withdrawn with subsequent obliteration of the GSV. Patients are allowed to resume normal activities after the procedure. Andover. Few (5 of 90) patients had pain that lasted longer than 1 week and required nonsteroidal analgesics. At 6-month mean follow-up 99% remain closed. Bloomington. Ecchymosis and mild discomfort can be expected. 810-nm laser ﬁber (Diomed. Ultrasound guidance is used to access the GSV at the level of the knee. These encouraging . This causes collagen contraction and endothelial damage. Teruya. compression stockings are worn for 1 week. 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]. This procedure can be performed in an oﬃce-based setting using local anesthesia following preoperative assessment with duplex ultrasound.035-inch j-tipped guide wire is then introduced into the vein and passed to the level of the proximal saphenous vein. The complications with this therapy were reported as minimal . Wavelength laser energy (810-nm) is delivered via a 600-lm ﬁber. The vein is compressed manually to oppose the vein walls and aid in the obliteration of the lumen. Indiana) is then inserted into the vein. Massachusetts) is then positioned 1 to 2 cm below the SFJ.H. The sheath should be of appropriate length to match the length of the treated GSV. J.1410 T. Proebstle et al  treated 29 patients with a 97% rate of GSV occlusion at 1 month. Treatment of symptomatic varicose veins Stab avulsion Resection of varicose veins by any method requires accurate preoperative marking of the areas to be treated. Bruising was present in 24% of patients at 1 week follow-up. The technique of stab avulsion phlebectomy was introduced by Dr. 3 months.2%) GSVs after initial treatment and at 9-month follow-up 351 of 359 (97. EVLT appears to be a viable option in the treatment of saphenous vein reﬂux. Stab avulsions can be performed through many small incisions. they must be deep enough to cut through the dermis. The modality is safe with acceptable midterm results. which was modiﬁed by use of sterile technique. A Muller hook is then used to blindly grasp the adventitia of the varicose veins. They evaluated 423 patients who had 499 GSVs treated with laser over a 3-year period. therefore with a lower cost procedure. Teruya. Min et al  assessed their mid. The original procedure. Of note. Once a portion of the vein is pulled out of the skin incision a hemostat clamp can be used to secure the . deﬁned as absence of ﬂow with color Doppler imaging. The incisions do not need to be any larger than 1 to 2 mm. 6 months. Most patients had resolution of their symptoms and improvement in the severity of varicose veins. however. 113 of 121 (93.4%) GSVs were thrombosed. Successful treatment of the GSV. is widely practiced. and yearly thereafter to assess treatment eﬃcacy and complications. This minimally invasive procedure along with RF ablation has produced excellent cosmetic results with few recurrent problems. The incisions are made using an ophthalmic knife or a #11 blade. Patients were evaluated clinically and with duplex ultrasound at 1 week. These are then marked with a surgical pen before the patient enters the operative suite. Varicosities are best identiﬁed by inspection and palpation with the patient standing. and should be considered the gold standard for removal of varicose veins . long-term data are necessary before either procedure can be considered as the new standard.T.H. ELVT has the advantage of less expensive disposable items. At 2-year follow-up.8%) GSVs remained closed. however. 1 year. Five patients developed superﬁcial phlebitis in varicose tributaries after treatment. was noted in 490 of 499 (98. Although both procedures appear to be eﬀective methods of eliminating saphenous vein reﬂux. 1 month. with the majority noted before 3 months. Careful prepping of the skin is then necessary to avoid removal of the marks. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1411 results have been reproduced by other authors. all treatment failures occurred before 9 months. J. Robert Muller in 1966 .and long-term results of EVLT. this had resolved in all patients by 1 month.L. This method can be repeated over the course of the varicosities keeping the incisions as far apart as possible. Teruya. 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. Movement of the resector is controlled to minimize tissue damage and the subsequent development of hematomas. and there is a deﬁnite learning curve necessary to achieve good results. A transilluminator is inserted below the dermis and tumescent anesthesia is inﬁltrated. Massachusetts) uses a light source beneath the skin for varicose vein visualization and a powered suction resector to perform the phlebectomy [43–45]. Gentle traction on the vein with sequential mosquito hemostat application ensures that a lengthy segment of vein is pulled out from each incision. The varicosities are aspirated. The lower extremity is then wrapped with a compression dressing. Formal vein ligations are unnecessary. This is used to hydrodissect the veins for subsequent excision and to create a larger area of transillumination.to 3-mm incisions made at the circumference of the area of varicose vein clusters. J.L. as they close in spasm after retracting from the skin incision. the resector is inserted opposite the light source. The skin incisions are closed with tape strips. and cosmetically acceptable procedure. A larger multicenter study involving 117 . morcellated and then removed by suction. 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. and the lower extremity is wrapped from foot to proximal thigh with compressive gauze and an elastic wrap to minimized hematoma formation .1412 T. The procedure is performed with two devices. Again. The blade rotates at various speeds in a forward. it is very important to remove all blood from within the tissues to minimize postoperative pain and hematoma.H. Although the veins are visualized using the transilluminator. After the veins are resected the area is inﬁltrated with more tumescent anesthesia to obtain hemostasis and remove all the subcutaneous blood. The vein is then divided and carefully resected in both directions. eﬀective. It begins with two 2. The transilluminator consists of a light from a 45-degree illuminator connected to a 300-watt light source. For simple varicose veins the resector is set at 500 rpm with suction on high. Ballard / Surg Clin N Am 84 (2004) 1397–1417 vein. Neither the incisions nor the dermal punches need to be closed. In 2000. reverse or oscillating manner. Spitz et al  demonstrated that TIPP is a safe. Transilluminated power phlebectomy (TIPP) The TrivexTM System (Smith & Nephew Andover. Improved hemostasis can be obtained with leg elevation and direct external pressure. The resector is a rotating blade protected by an outer sheath with suction attached to it. There is a port on the transilluminator for the instillation of tumescent anesthesia. The procedure is operator dependent. There was no diﬀerence in pain. Patients must have no contraindications to sclerotherapy. for fear that the sclerosant will reach the deep system and cause complications. it is unclear whether this was a result of TIPP or the GSV stripping that was performed at the same time. however. and several new sclerosing agents are being developed.H. Saphenous nerve injury was observed in 41 patients.L. However. There was one DVT and a single death 29 days after the procedure. Ultrasound guidance is used to identify the saphenous vein. They randomized 188 limbs in 141 patients to conventional phlebectomy versus TIPP. They also demonstrated the procedure to be safe and eﬀective. However. However.5) and operating time (mean 14 minutes for TIPP. Two serious adverse outcomes were reported. This is likely due to inadequate sclerosant injected in the GSV or LSV. this was not statistically signiﬁcant. range 3 to 75 minutes). however. two patients of 30 required reoperation for hematoma evacuation. however. At the present time there are no foam sclerosants commercially available. 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. There was a trend toward lower operating time in the TIPP group. foam sclerotherapy can be performed by mixing currently approved sclerotherapy agents with air to create microfoam. Orbach introduced the concept of sclerotherapy using an intravenous air block a half-century ago . Foam sclerotherapy Agents that damage the venous endothelium and subsequently cause obliteration of the vein lumen are not a novel concept. Foam sclerotherapy is gaining acceptance is Europe. Sclerotherapy is highly eﬀective in the treatment of small varicose veins and reticular veins.T. presumable from a myocardial infarction. J. Ballard / Surg Clin N Am 84 (2004) 1397–1417 1413 limbs. or satisfaction at any time period during followup. performed in Europe and the United States conﬁrmed that the procedure could be performed safely with satisfactory results for the patient . Local anesthesia in the skin at . they also emphasized the fact that there is a learning curve with the TIPP procedure. Teruya. The surface area of the sclerosant is larger. and therefore the agents are more eﬀective. standard sclerotherapy has been disappointing in the treatment of large superﬁcial veins. The authors commented that with experience the operator could reduce operative time and the incidence of postoperative hematomas. Patients who underwent TIPP required fewer incisions. Shamiyeh et al  demonstrated patient satisfaction in the majority of patients. however. This study reported that the beneﬁt of TIPP for removal of varicose veins was a decreased number of incisions (mean 3. Aremu et al  evaluated TIPP in a prospective randomized trial comparing this procedure with conventional phlebectomy. Patients did suﬀer signiﬁcant ecchymosis. by 6 weeks this had resolved in all patients. cosmesis. In one study. Other authors have also demonstrated excellent long-term results in the treatment of greater and LSV reﬂux using this technique.2: 1070–1. Kechejian GJ.L.  Hanrahan LM. and TIPP represent eﬀective and possibly superior alternatives to traditional saphenous vein stripping and stab avulsion of varicose veins. elimination of reﬂux was noted in virtually all patients at 3. Teruya. Araki CT. and TIPP are unnecessary for foam sclerotherapy. and will become a useful extension to standard sclerotherapy. Menzoian JO. References  Fegan WG. The VEDICO trial compared the treatment of varicose veins using several techniques including sclerotherapy. and can be performed on an ambulatory basis. Henry M. and 12 months follow-up .1414 T. Single treatment of foam sclerotherapy using ultrasound guidance was eﬀective in obliterating the GSV in 81% of cases. more serious complications can include anaphylaxis and intraarterial injection [47–50]. minimally invasive techniques for the treatment of varicose veins including RFA. J Vasc Surg 1991. However. Retreatment was necessary in only a few cases. J. However. This trial demonstrated that foam sclerotherapy was as eﬀective as surgery in the treatment 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. such as foam sclerotherapy. The procedure is relatively simple to perform. . This treatment was eﬀective in eliminating varicose veins in 96% of cases. External compression at the SFJ can prevent entry of the agent into the deep venous system. will replace the procedures that we currently use today. Some of these new techniques may not prove to be eﬀective in the hands of all treating specialists. Lambe R. Lancet 1967. Minor complications of the procedure are reported to be pigmentation and superﬁcial thrombophlebitis. Foam sclerotherapy holds great potential. and foam sclerotherapy . LaMorte WW. 6. Minimal anesthesia is required and the procedure can be oﬃce-based in essentially all practices. it is very likely that some of these techniques. EVLT.H. Summary New. Ballard / Surg Clin N Am 84 (2004) 1397–1417 the site of injection can be used to decrease pain. surgery. The saphenous vein is then injected with the foamed sclerosant. Rodriguez AA. Steroid hormones and varicose veins. Cabrera et al  demonstrated that foam sclerotherapy was eﬀective in treating varicose veins with saphenous reﬂux in 86% of patients. EVLT. Compression dressings are then placed. Expensive equipment required to perform RF ablation. 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