Endoluminal Varicose Vein Therapy
Jerry G. Ninia, MD
Clinical Associate Professor OB/GYN
SUNY- Stony Brook School of Medicine
American College of Phlebology
Primary venous insufficiency is characterized by the development of varicose veins of the lower extremities. The Great Saphenous Vein (GSV) is the major vein of the superficial venous system and reflux in the GSV is often associated with large superficial varicies. These varicies can cause the patient significant discomfort. Additionally, varicose veins can give rise to ambulatory venous hypertension with its associated skin changes and ulceration. In fact, up to 80% of venous stasis ulcers are due to venous disease. If incompetence of the Saphenofemoral junction is detected, treatment is medically indicated. A new treatment modality using endoluminal laser therapy via a percutaneous technique is described. Most patients can gain significant relief from this in-office procedure.
Up to 25% of women suffer from lower extremity varicose veins and its associated superficial venous insufficiency. (1) Female gender, heredity, pregnancy, hormones, aging and standing occupations all contribute to the development of varicose veins. (2) While some patients seek medical treatment for varicose veins for cosmetic purposes, most patients with varicose veins experience significant discomfort. These symptoms include sharp or dull pain, night cramps, fatigue, heaviness or restlessness. Typically, these symptoms are worsened with prolonged standing, in warm weather and in the luteal phase of the menstrual cycle. (3) If untreated, many patients with significant superficial venous insufficiency will develop skin changes of ambulatory venous hypertension characterized by edema, hyperpigmentation, lipodermatosclerosis and eventually ulceration. (4) Traditionally, varicose veins are treated with surgical stripping of the GSV from the groin to just below the knee. (5) Unfortunately, this procedure is characterized by significant morbidity and the potential for neovascularization. In fact, neovascularization is the principal cause of recurrence in spite of proper vein stripping. (6) Injection-compression sclerotherapy (7), ultrasound-guided sclerotherapy (8), ambulatory phlebectomy (9) and ultrasound-guided foam sclerotherapy (10) has been described as well. A new treatment modality involving endoluminal laser therapy has been described in the literature with excellent results. (11, 12, 13) A less invasive alternative to stripping, the device allows for the application of laser energy directly into the lumen of the vein. The technique can be performed in the office with ultrasound guidance and local (tumescent) anesthesia. A knowledge of the anatomy and physiology of the superficial and deep venous system is important in the evaluation and management of these patients.
Anatomy / Physiology
The veins of the lower extremity consist of two pathways- one superficial and one deep in the muscular system. (Figure 1.) Varicose veins involve the superficial component of the systemic venous system which consists of the GSV, Small Saphenous Vein (SSV) and perforating (communicating) veins.
The GSV is the largest and longest vein in the superficial venous system. It begins on the medial side of the foot and courses superiorly anterior to the medial malleolus, along the anterior surface of the tibia. It continues posterior and medial to the knee and continues along its course in the saphenous space along the medial aspect of the thigh. It eventually drains into the common femoral vein at the saphenofemoral junction (SFJ). (Figure 2.) The SSV begins at the lateral aspect of the foot, posterior to the lateral malleolus. It courses superiorly up the calf and drains primarily into the popliteal vein. Sometimes, the SSV drains directly into the GSV and rarely it may drain into the gluteal vein. The Giacomini vein is the cephalad extension of the SSV. Perforating veins link the superficial and deep venous systems. Major perforating veins include the Hunterian (mid-thigh), Dodd's (superior to knee), Boyd's (inferior to knee) and Cockett's (lower leg) veins. There are three Cockett's perforating veins and they tend to arise from one of the two paired posterior arch veins. Competent valves in the perforating veins prevent reflux of blood from the deep to the superficial veins, whereas incompetent perforating veins are an important cause in the development of varicose veins. Mediated by an efficient calf muscle-pump, 90% of the venous blood of the lower extremities is returned cephalad to the right atrium of the heart via the deep venous system. The paired anterior tibial veins, posterior tibial veins and peroneal veins merge to form the popliteal vein. As the popliteal vein crosses the popliteal fossa, it changes its name to the femoral vein. Some authors refer to this vein as the "superficial femoral vein." "Superficial" here is a misnomer since the vessel is in fact part of the deep venous system. In fact, this vessel is the largest and longest vein of the deep venous system. The femoral vein then merges with the shorter and broader deep femoral vein (profunda femoral vein) and eventually drains into the common femoral vein. It is important when performing endoluminal laser venous ablation to be mindful of the venous anatomy and, with ultrasound guidance, be certain of correct placement of the laser fiber within the lumen of the GSV approximately 1 cm below the SFJ.
History and Physical Examination
A directed history and physical examination should be performed with an emphasis on the lower extremities of patients with varicose veins. A detailed history including type and duration of symptoms should be recorded. Any improvement with support stockings should be noted as well. Inability to ambulate, active deep vein thrombosis, poor health and pregnancy would be contraindications to treatment. Physical examination may show varicies, reticular veins and telangiectasias. Skin changes related to ambulatory venous hypertension are best documented with photography. Ultrasound can assist with the mapping of these findings onto the patient's chart.
More than any other non-invasive diagnostic tool, duplex ultrasound has emerged as the most accurate, cost effective and efficient method in the evaluation of patients with venous disease. (14) Its use transcends the initial evaluation and mapping to include marking of the patient's skin prior to the procedure, intra-operative guiding during the procedure and post-operative checking and follow-up.
Initially, the patient is examined in the upright position with weight shifted onto the opposite leg. Starting at the groin and working inferiorly, the course of the GSV is identified in its characteristic location within the fascial sheath. (Figure 3.) Vein diameter should be measured along with documentation of reflux by Doppler analysis. (Figure 4.) Reflux is demonstrated by an audible retrograde flow of greater than 0.5 to 1 second while manually compressing and releasing the calf muscles. Significant reflux of 2 seconds or greater is often associated with skin changes characteristic of venous insufficiency. This is what is often required to secure reimbursement as a medically necessary procedure.
After venous duplex mapping and patient marking a percutaneous entry point is chosen usually superior and medial to the knee. An 18 gauge 2 inch angiocatheter is introduced into the GSV with ultrasound guidance. A 0.035 inch-diameter J guide wire is placed through the angiocatheter and directed up towards the SFJ. The angiocatheter is removed and a 5-F sheath is placed over the guide wire. The guide wire is then removed and replaced with a sterile, bare-tipped 600 micron diameter laser fiber. Supplies can be obtained from various sources. (Cook, Bloomington, IN) (Total Vein Solutions, Houston, TX) (Vascular Solutions, Minneapolis, MN) The tip of the laser fiber is positioned just outside of the laser sheath and placed with ultrasound guidance 1 cm below the SFJ. Placement is confirmed by direct visualization of the red aiming beam of the laser fiber through the skin. If the red aiming beam is not seen it would suggest that the laser fiber was introduced too far along the course of the GSV and it is incorrectly placed within the Common Femoral Vein (CFV). In this circumstance, the laser fiber and sheath need to be withdrawn until the red aiming beam is seen through the skin and the laser tip is visualized with ultrasound guidance at 1 cm below the SFJ.
Tumescent local anesthesia is administered using a modification of the Klein technique. (15) This consists of approximately 150-200 ml of a dilute lidocaine solution buffered with sodium bicarbonate. Performed with ultrasound guidance, the GSV is "floated" within its fascial sheath. In addition to anesthesia, this serves to compress the diameter of the GSV, may place the vein into spasm and provides a "heat sink" by preventing injury to adjacent tissues. Patients may be pre-medicated with 0.5 mg of the anxiolytic Alprazolam 30 minutes prior to the procedure as well.
Blood flow noted in a patient CFV post procedure.">After the administration of tumescent anesthesia, laser tip placement is rechecked with ultrasound. Laser energy using a 980 nm diode laser (Biolitec, East Longmeadow, MA) is delivered at 10 Watts in a continuous mode. Ideally, energy should be delivered to the vein lumen at 60 Watts per cm length. By knowing the length of the vein, the physician can determine the overall amount of energy to be delivered and withdraw the laser fiber and sheath together at an appropriate rate. This can be performed simply and accurately by using the 10 cm markings along the sheath in conjunction with the time display in seconds on the laser unit. If the vein diameter is greater than .8 cm or 1.0 cm in diameter, then 12 Watts or 14 Watts continuous can be used respectively. Withdrawl time is paced at about 10 cm per minute. The vein is treated to about 1 cm above the percutaneous entry site.
A Class II (30-40 mmHg) thigh-high graduated compression stocking is immediately applied to the treated leg and worn overnight and then for seven more days while the patient is up and on her feet. (Juzo, Cuyahoga Falls, OH) The stocking may be removed at bedtime and to shower. Patients are encouraged to ambulate and to resume their normal activities. Ibuprofen 600 mg TID is prescribed for 3 days. Physical examination and ultrasound follow-up is performed at 3 to 7 days post treatment. GSV wall thickening and fibrosis are noted along with documentation of adequate flow in the CFV. (Figure 5.) Although a resolution of symptoms and an improved cosmetic appearance is noted often within one month of treatment, some patients will need additional therapy with injection-compression sclerotherapy or ambulatory phlebectomy in order to achieve maximum results.
A new technique for endovenous occlusion using endoluminal laser offers a less invasive alternative to surgical vein stripping. It can be performed in the office with ultrasound guidance and local anesthesia. Patients are awake during the procedure and fully ambulatory with no "down time" after the procedure. Meta-analysis of results have been excellent. A recent study (13) in 701 limbs treated in 610 patients demonstrated a 98% successful venous occlusion rate at over 3 years follow-up. Moreover, 99% of patients with symptoms had resolution and would recommend treatment to a friend or family member. There were no skin burns, deep vein thromboses or paresthesias. Results were indeed similar or superior to other GSV reflux treatment options.
The specialty of Phlebology along with an understanding of venous disease continues to improve dramatically and grow with input from a variety medical specialists including vascular surgeons, interventional radiologists, dermatologists and primary care physicians- including obstetrician/gynecologists. This diversity is seen through the membership of the American College of Phlebology (www.phlebology.org). In the future, many properly trained physicians will be able to diagnose the full range of superficial venous disease and offer acceptable treatment options to those patients unwilling or unable to undergo surgery.
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