Lower-extremity varicosities: Endoluminal therapy

Lower-Extremity Varieosities: Endoluminal Therapy Robert J. Min and Neil M. Khilnani

NSUFFICIENCY OF THE superficial venous system is extremely common, with estimates of 25% of women and 15% of men suffering from varicose veins. 1 Although varicose veins are often considered a normal physical finding, they should more correctly be thought of as a medical condition with the majority associated with symptoms. In Europe, phlebology has been fully accepted by the medical community for decades and exists as a separate specialty. Unfortunately, this is not the case in the United States, with most physicians still not fully aware of the latest treatments available for varicose veins. Recently, there has been increased interest in venous disorders with phlebology now being practiced not only by surgeons but also by dermatologists, radiologists, gynecologists, and internists.

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ANATOMY AND PATHOPHYSIOLOGY OF VARICOSE VEINS

The venous system of the lower extremities consists of the deep and superficial systems, with multiple interconnecting or perforating veins. These components must act in concert with dysfunction of any 1 system leading to dysfunction of the other 2. The most important veins within the superficial venous system make up the saphenous system, consisting of the greater (or long) saphenous vein (GSV) and the lesser (or short) saphenous vein (LSV). One-way valves allow blood to return back to the heart against gravity, driven by the calf muscle pump. Valves at the saphenofemoral junction (SFJ), saphenopopliteal junction (SPJ), and within perforating veins direct blood from the superficial to the deep veins. Many theories on the nature of varicose veins have been proposed. One hypothesis divides varicose veins into primary and secondary. Primary varicose veins are those veins that develop because of a congenital weakness in the vein wall or the valve cusps or by a deficiency in the number of

From the Cornell Vascular, Weill Medical College of Cornell University, New York, NY. Address reprint requests to Robert J. Min, MD, 416 East 55th Street, New York, N Y 10022. Copyright 2002, Elsevier Science (USA). All rights reserved. 0037-198X/02/3704-0011535.00/0 doi: l O.1053/sroe.2002.35477 354

valves. The primary abnormality leads to luminal distension and valvular incompetence, resulting in venous reflux.2-7 Secondary varicose veins are those resulting from an episode of prior thrombosis and subsequent recanalization with the inflammatory process leading to valvular damage) Varicose veins occur more commonly in women than men and hereditary factors seem to play an important role. Pregnancy, hormones, aging, prolonged standing or sitting, obesity, constipation, leg trauma, or congenital conditions are additional factors that may accelerate the appearance or worsening of varicose veins. 9,1° SYMPTOMS Although many people seek medical treatment for varicose veins because they find them unsightly, most people with varicose veins suffer from symptoms. 11.~2The most common complaints associated with varicose veins include leg pain, night cramps, fatigue, heaviness, or restlessness. Left untreated, varicose veins can lead to lowerextremity swelling, eczema, pigmentation, hemorrhage, and ulceration. Symptoms typically are worsened with prolonged standing, during the premenstrual period, or in warm weather. ~3 Some reports estimate that nearly 50% of major varicose veins will lead to chronic venous insufficiency, 14 often resulting in venous hypertension and the following sequelae of chronic venous hypertension: (1) swelling caused by excess caprilary exudate; (2) induration and eczema caused by fibrosis from reduced nutrition, chronic inflammation, and fat necrosis; (3) pigmentation caused by extravasation of red blood cells with accumulation of hemosiderin; and (4) ulceration and necrosis of the skin secondary- to poor nutritional exchange CLINICAL AND NONINVASIVE EXAMINATION

Physicians unfamiliar with disorders of the superficial venous system often underestimate the complexity of the condition and the importance of a proper history and examination. Valuable information to be gathered includes the duration and evolution of the problem, presence and severity of symptoms, prior treatments, and possibility of prior deep venous thrombosis. Physical examination is performed in the standing position and consists of careful inspection, palpation, and per-

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Fig 1. (A) Transverse ultrasound image of an enlarged right GSV measuring 10 mm x 10 mm in diameter. (B) Longitudinal color doppler and pulsed wave doppler examination show incompetence of the SFJ with GSV reflux.

cussion. Examination should include not only the legs but also the lower abdomen and pubic area. Additional evaluation using a variety of noninvasive diagnostic instruments may be necessary when determining the cause, severity, and best treatment options available for a particular patient. These tests include continuous wave doppler, photoplethysmography, and duplex ultrasound. The goal of noninvasive testing is to construct a precise map of the pathways of venous incompetence, including sources of reflux (SFJ, SPJ, perforators), abnormal tributaries, and determination of vein size and morphology. This will ensure complete treatment of all involved veins while preserving those that are normal.

Duplex Ultrasound There is no doubt that duplex ultrasound imaging is more expensive than continuous wave doppler, and many patients will have adequate diagnosis and treatment of their veins without duplex scanning, but duplex examination is invaluable in certain patients. Variations in venous anatomy are very common and may lead to atypical patterns of reflux, which may be difficult to determine with simple physical examination or continuous wave doppler. Common examples include (1) duplication of the GSV, (2) aberrant termination of the LSV (present in 20%-40%), and (3) variable connections of the LSV with gastrocnemial veins. Duplex ultrasound is also invaluable when evaluating patterns of reflux other than SFJ incompetence. Common examples include (1) normal GSV but in-competent anterolateral tributary, (2) reflux

in GSV transmitted by external pudendal and/or gluteal varices, (3) reflux from enlarged superficial epigastric branches on the lower abdomen, and (4) reflux in GSV transmitted by a variety of perforating veins. Other uses for duplex ultrasound include directing treatment in complex or difficult areas and providing reliable and objective assessment after treatment. Duplex ultrasound evaluation should be performed with the patient standing because this is the position in which abnormalities of the superficial venous system are most evident. For the GSV, the patient's weight is supported on the contralateral limb with the leg to be examined slightly flexed and turned outward. The groin is examined first, locating the SFJ and checking for competency. At the same time, the common femoral vein can be assessed for gross evidence of obstruction or insufficiency. The GSV should be followed, noting size and presence of reflux. Perforators should be evaluated in the transverse plane and competency determined. The typical sonographic appearance (transverse view) of an enlarged right GSV measuring 10 mm × 10 mm in diameter is seen in Figure 1A. Figure 1B shows incompetence of the SFJ with GSV reflux (longitudinal view) on color doppler and pulsed wave doppler interrogation. For the LSV, the patient faces away with the knee slightly flexed (relaxes the muscle and prevents possible compression of the vein by the artery or muscle). The LSV is first examined in the transverse plane. It is important to note the position and arrangement of the junction of the LSV and deep venous system, including the position of the

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gastrocnemial veins. The size and competency of the LSV should be assessed. TREATMENT: SCLEROTHERAPY

Although treatment of varicose veins by sclerotherapy has been practiced for decades, the technique continues to evolve and improve. New sclerosants, compression, and standardization of treatment methods have contributed to this progress. The goal of sclerotherapy is to cause endothelial and vein wall damage, resulting in a fibrous cord, which is eventually reabsorbed.

Indications Telangiectasia and associated feeding reticular veins, varicose tributaries with normal saphenous veins, residual or recurrent varicose veins after surgery, and varicose veins caused by perforator incompetence (as an alternative to ambulatory phlebectomy) are all indications.

Contraindications Inability to ambulate, deep vein thrombosis, hypercoagulability, allergy to sclerosing agent, nonpalpable pedal pulses, pregnancy or breast feeding, and general poor health are all contraindications.

Strategy Although there are different schools of thought regarding the technique of sclerotherapy, most phlebologists follow the French school led by Tournay. This method relies on starting treatment from the highest to the lowest point of reflux, and from the largest to the smallest veins. ~5

Technique Injections are usually performed with the patient in the supine position. This reduces venous pressure, allows injection into an empty vein, and decreases the likelihood of a vasovagal reaction. The angle of entry into the vein should be approximately 15 ° to 30 ° to the skin depending on the depth of the target vein (Fig 2). Slight negative pressure should be applied to the syringe with aspiration of venous blood indicating entry into the vein lumen. Injection of sclerosant should be painless to the patient. Determination of the starting dose and concentration of sclerosant is made based on a number of factors. For most varicose veins, the most impor-

Fig 2. Typical positioning of syringe and needle during sclerotherapy, Angle of entry is approximately 15 ° 30 ° with application of slight negative pressure to the syringe,

tant factor will be the diameter of the vein, but other factors such as the type and location of the varicose vein and the patient's age and skin color must also be taken into account. The goal is to cause complete destruction of the vein wall using the smallest dose of sclerosant necessary. After each set of injections, compression bandages or graduated support stockings are worn. Although disagreement exists as to the optimal length of time for postsclerotherapy compression, most phlebologists suggest 3 days to 2 weeks depending on the size of the treated veins. 16,~7 Ambulation should be encouraged following the procedure. A follow-up visit should be scheduled for 1 or 2 weeks to examine the treated area and to remove any areas of thrombosis. These areas of trapped blood can be associated with pain or tenderness and can lead to hyperpigmentation, telangiectatic matting, or recanalization. Puncture with a 25-gauge orl8-gauge needle and expression of the thrombus will provide symptomatic relief and will minimize side effects.

Adverse Reactions Serious complications when sclerotherapy is properly performed are rare but may include cutaneous ulceration, allergic reaction, arterial injection, or deep venous thrombosis. Although a small amount of hyperpigmentation and telangiectatic matting may be seen in a significant number of patients undergoing sclerotherapy, the vast majority of these cases will be temporary, resolving in less than 3 months, 18

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TREATMENT OF THE INCOMPETENT GREATER SAPHENOUS VEIN

The GSV is the major vein of the superficial venous system and is often the underlying cause for significant varicose veins. When incompetence of the SFJ is detected, treatment should first be directed toward eliminating this source of reflux with ablation of the incompetent venous segments. In the past, treatment of an incompetent GSV has necessitated surgical ligation and stripping. The drawbacks of this approach include risks associated with general anesthesia, surgical complications (paresthesia, bleeding, infection, scars), increased in-hospital costs, and prolonged recovery periods. Furthermore, surgical treatment of the GSV is not free from recurrence. Sarin et al 2° reported an 18% rate of recurrent GSV reflux after ligation and stripping and a 45% rate of recurrence after high ligation alone, appearing as early as 3 months after treatment. ~9 Similarly, Dwerryhouse et al 2° found a recurrence rate of 29% after ligation and stripping of the GSV and 71% after high ligation alone. Consequently, less invasive alternatives to surgical treatment of the incompetent GSV have been developed and are gaining rapid popularity. Early attempts to selectively damage saphenous veins to occlude them involved electrocoagulation. 21-23 Over the past decade, ultrasound-guided sclerotherapy has been used in select cases and appears to be effective in expert hands with an estimated 50% to 80% 1-year efficacy.24,25 Major risks of sclerotherapy of saphenous veins include anaphylaxis and extraluminal or intra-arterial injections, although the risk of the latter complications is virtually eliminated with transcatheter techniques. 26,27 Foam sclerotherapy may improve efficacy but likely does not decrease risk. 28 A bipolar radiofrequency (RF)-based energy source delivered by a disposable catheter (VNUS Medical Technologies, Inc, Sunnyvale, CA) has shown promise. Early results reported from a multicenter trial showed an overall recanalization rate of 10% at a mean follow-up of 4.7 months (13% in patients treated with RF alone and 5% in patients treated with RF plus high ligation of the GSV). Complications included paresthesias (thigh 9%, leg 51%), 3 skin burns, 3 deep venous thromboses (occurring in the 86 patients treated without high ligation), and 1 pulmonary embolus? 9 More recent studies with RF closure of the GSV have

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supported these early results with recurrence rates of GSV reflux in 10% of 140 limbs followed up to 24 months. 3° Effective use of tumescent anesthesia also appears to have reduced the incidence of heat-related complications with RF closure. The newest minimally invasive technique to be developed is endovenous laser. Endovenous laser treatment (EVLT; Diomed Inc, Andover, MA) allows delivery of laser energy directly into the blood vessel lumen to produce endothelial and vein wall damage with subsequent fibrosis. Compared with existing endoluminal techniques such as ultrasound-guided sclerotherapy or RF ablation, endovenous laser has the following potential advantages: (1) transmission of energy through a small diameter, flexible fiber permitting a wider range of treatable veins with minimal access site size; (2) shallow depth of penetration of laser energy and faster withdrawal rates resulting in less damage to surrounding nontarget tissue compared with RFbased energy sources; (3) patients with pacemakers are not excluded from endovenous laser treatment; (4) avoidance of risks of extraluminal or intraarterial injection and minimal risk of anaphylaxis compared with ultrasound-guided sclerotherapy; and (5) precise control of vein wall damage may lead to lower rates of recanalization compared to chemical closure (ie, sclerotherapy)

EVLT: Technique After mapping of the GSV with duplex ultrasound, a percutaneous entry point is chosen. This point may be when reflux is no longer seen or when the GSV becomes too small to access (usually just above or below knee level). Using local anesthesia and sonographic guidance, the GSV is entered and a 5-Fr, 45-cm long introducer sheath is placed into the GSV over a guide wire. Intraluminal position within the GSV is confirmed by aspiration of nonpulsatile venous blood and visualization with ultrasound. A sterile, bare-tipped 600-~m diameter laser fiber (Laser Peripherals, Inc, Minnetonka, MN) is introduced into the vein through the sheath exposing 1 to 2 cm of distal fiber tip. The laser fiber and sheath are withdrawn together and positioned just below the SFJ using sonographic guidance (Fig 3). Position is confirmed by direct visualization of the red aiming beam of the laser fiber through the skin. Perivenous local anesthesia (100-150 mL lidocaine, 0.25% with or without epinephrine) is ad-

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Fig 3. Longitudinal duplex ultrasound image showing the distal tip of laser fiber and sheath positioned at the SFJ.

ministered along the GSV using sonographic guidance. In addition to the anesthetic effects, properly delivered, this fluid serves 2 important functions. It compresses and reduces the diameter of even the largest veins to provide vein wall apposition around the fiber tip (Fig 4) with subsequent circumferential heating of the vein wall and provides a heat sink to minimize the possibility of heatrelated damage to adjacent tissues. The laser fiber tip is positioned 5 mm below the SFJ and 810-nm wavelength diode laser energy is delivered endovenously along the course of the GSV as the fiber and sheath are withdrawn as seen in Figure 5. Laser energy is provided by the Diomed D15 Surgical Laser (Diomed, Inc, Andover, MA) using the following parameters: 14 W

Fig 4. Transverse duplex ultrasound image showing lidocaine fluid surrounding the sheath and fiber within a compressed GSV. (Note the echogenic needle tip within the fluid adjacent to the compressed GSV.)

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Fig 5. Laserfiber and sheath are slowly withdrawn as laser energy is delivered endovenously into the GSV.

continuous mode at a pullback rate of approximately 3 to 5 mm/s. Class II (30-40 mm Hg) graduated compression stockings are worn for 1 week after treatment. Patients are instructed to walk immediately after the procedure and to continue their normal daily activities with the exception of vigorous gym workouts. Tributaries are treated with compression sclerotherapy, as needed, beginning 4 weeks after endovenous laser treatment. EVLT: Results

Two hundred ninety-seven out of three hundred five (97%) GSVs were successfully dosed (defined as no flow detectable on follow-up color Doppler interrogation) after initial EVLT. Of the 7 GSVs not closed initially, 6 were successfully treated after repeat EVLT. Two hundred ninety-eight out of three hundred four (98%) GSVs remain reflux free at 3 to 30 months follow-up. The procedure was well tolerated by all patients under strictly local anesthesia. Bruising at the percutaneous entry site, lasting 7 to 10 days, and mild to moderate discomfort along the treated GSV was noted in the majority of patients. Tightness along the GSV, peaking on days 5 to 7 after EVLT, was often described as a "pulling sensation." This appears to correspond to vein wall thickening seen on duplex imaging and may indicate successful treatment with adequate damage to the vein wall. There were no skin bums, paresthesias, deep venous thromboses, or other adverse reactions. The typical appearance of varicose veins caused by incompetence of the SFJ with GSV reflux is shown in Figure 6. After EVLT and 3 follow-up sclerotherapy sessions, resolution of symptoms,

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Fig 6. Left lower-extremity varicose veins caused by SFJ incompetence with GSV reflux.

and significant improvement in the appearance of the varicose veins is noted in Figure 7. CONCLUSION

The understanding of venous disorders continues to improve with tremendous strides being made over the past decade. Readily available noninvasive diagnostic tests allow physicians to precisely map out abnormal venous pathways and identify sources of incompetence. Minimally invasive percutaneous treatment alternatives to surgery have been developed with impressive midterm

Fig 7. Dramatic improvement in the appearance of previously noted varicose veins seen in Figure 6 after EVLT and sclerotherapy treatment,

results demonstrating safe and effective treatment of incompetent G S V s ? °-33 Given these recent advances, radiologists, in particular interventional radiologists, are perfectly suited to offer diagnosis and treatment for the whole spectrum of venous disease, including even the largest varicose veins. This will allow more physicians, once properly trained, to offer treatment to the millions of people in the United States alone who suffer from varicose veins but are unwilling or unable to undergo surgery.

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