Varicose Vein: Current Management
Chronic venous insufficiency can be found in 15% to 20% of the population. The prevalence goes up to 50% if small telangiectasias are included [1]. Venous ulcers are observed in 2% of patients with chronic venous insufficiency, and the treatments of these ulcers alone carry a significant cost [2]. Several risk factors for the development of varicose veins have been identified, which include age, female gender, multiparity, family history, obesity, and job activities that involve prolonged standing. Obesity seems to be a risk factor only in women but not in men. Exercise activity seems to be protective in men but not in women. In at least one study, however, trunk varices were observed to be more prevalent in men [1].
Etiology
The etiology of chronic venous insufficiency is believed to involve one or a combination of the following: venous obstruction, valvular insufficiency, and calf muscle pump dysfunction. Valvular insufficiency is the most common cause, and most valvular insufficiency cases involve the superficial veins of the lower extremity. Deep vein thrombosis (DVT) is a primary cause of valvular insufficiency and obstruction in the deep system. Calf muscle pump dysfunction leads to the inability of the blood column to properly exit the lower extremity. Similar to all are stasis and persistent venous hypertension, which eventually result in the sequelae of chronic venous insufficiency [2].
Signs, symptoms, evaluation, and treatment
Common complaints of patients with chronic venous disease include pain, swelling, leg heaviness or throbbing, itching, and cramps. Skin changes (hyperpigmentation, eczema, lipodermatosclerosis, or atrophie blanche) and ulcer formation are seen in more advanced presentations of the disease. Varicose veins are defined as dilated (>3 mm) subcutaneous veins that are visible and palpable. These veins can elongate and have significant tortuosity. Varicose veins can be trunk varices or those limited to branches [2,3].
The evaluation of a patient with chronic venous disease should incorporate the CEAP classification, which classifies the patient’s disease severity based on clinical signs, etiology, anatomic location, and pathophysiology (Box 1) [4]. The severity of the patient’s symptoms is evaluated using the Venous Clinical Severity Score (VCSS) and it is the best determination of treatment effectiveness over time. The VCSS classifies disease severity based on pain, presence plus extent of varicose veins, edema, inflammation, skin pigmentation, as well as the number, size, and duration of ulcers. The use of compression stockings is also assessed within the VCSS [5].
Venous duplex ultrasonography (US) has become the primary diagnostic tool in the evaluation of chronic venous disease. Significant reflux is defined as reflux longer than 0.5 seconds with rapid release of distal compression, and greater than 1 second with the use of manual compression. US examination should also include the small saphenous vein because it can be a source of significant and clinically relevant reflux [2]. Duplex US plays a prominent role not only in the evaluation of patients before and after treatment but also during interventions as is discussed later. There are 4 different emerging treatment modalities for varicose veins. The traditional open surgery consisting of high ligation and stripping of the greater saphenous vein (GSV) has been largely replaced by either form of endothermal vein ablation in the United States or the use of foam sclerotherapy (FS) in Europe.
Radiofrequency ablation
Preoperative duplex US is obtained to determine the presence of superficial saphenous vein reflux and the absence of DVT (Fig. 1). Duplex US is also helpful in preoperative planning of the length of vein to be treated and choice of catheter length to be used. The ClosureFAST system comes in either a 60-cm or 100-cm length. Treatment can certainly be done under local anesthesia and with monitored sedation, but general anesthesia can also be used to provide optimal pain control. The patient is positioned appropriately depending on the vein segment being treated, GSV (supine) or small saphenous vein (prone). During the initial phase of the operation, the patient is positioned in a reverse Trendelenburg position to dilate the veins and allow easy percutaneous access and guidewire placement. A scrubbed ultrasonographer is also present in the operating room to aid in mapping the GSV, to aid in proper catheter placement, and to confirm a successful intervention, but many interventionalists perform the intraoperative duplex imaging themselves.
The intraoperative duplex imaging allows the surgeon to choose an appropriate segment of the vein for percutaneous placement of the 7F sheath. A standard Cook needle is used to access the vein under ultrasound guidance. If the access site involves a small caliber vein, a micropuncture needle can be used, and the microsheath is exchanged for the 7F sheath. Cutting down access to the saphenous is always an alternative. The 0.025-in guidewire is passed through the needle and into the common femoral vein (CFV) if easily advanced. The 7F sheath is inserted and a Bernstein catheter is used to help position the guidewire into the CFV if not previously positioned. The ClosureFAST catheter is introduced over the wire to below the superficial epigastric vein and 2 cm below the SFJ (Fig. 2). Appropriate positioning of the catheter tip is achieved with ultrasound guidance. The patient is then placed into the Trendelenburg position to decompress the vein. Tumescence anesthesia is injected into the saphenous compartment under ultrasound guidance. The RF catheter can be visualized within the vein by US and presents a confirmation of proper infusion and venous compression around the catheter. The recommended amount of tumescence used is 10 mL/cm of vein being treated, but, in reality, it is intended to fill the saphenous compartment and compress the vein around the catheter. The typical tumescence solution consists of lactated Ringer and buffered lidocaine with epinephrine (Box 2) [6]. The manufacturer recommends achieving a distance of at least 1 cm filled with tumescence fluid between the vein being treated and the skin. Tumescence serves several functions, including compressing the vein, preventing thermal injury to the skin, decreasing nerve injury, and providing local anesthesia.
After injection of tumescence fluid, the first segment closest to the SFJ is treated twice. Significant external compression is applied during RF treatment to allow for maximal vein wall compression around the catheter electrode. The process is repeated in 7-cm lengths until the entire course of the vein has been treated. Careful recognition of the catheter markings must be observed to prevent thermal treatment within the sheath or near the skin surface as the last segment of vein is treated. The mechanism of action is heating of the vein wall, which essentially causes localized injury to the treated site. This process leads to the denaturation of the collagen matrix and eventual fibrotic sealing of the lumen. Both the duration of treatment and actual tissue temperature achieved determine the total vein shrinkage [6]. The ablation is then completed with a duplex US examination of the treated area to ensure that there is no thrombosis involving the SFJ or the deep veins (Fig. 3). Presence of DVT after this procedure requires acute treatment with anticoagulation. The device instructions for use discourages immediate retreatment of an acutely treated vein and recommends duplex US within 72 hours postprocedure for DVT detection. In general, the authors ask their patients to return within 1 week for follow-up and a repeat duplex US study. The patients are also instructed to maintain the compression dressing for at least 72 hours and refrain from strenuous activities or any heavy lifting; however, normal ambulation is encouraged.
The evolution of the RFA treatment of varicose vein is nicely detailed by Lohr and Kulwicki [6]. The initial use of endoluminal RFA for treatment of varicose veins was reported in Bern, Switzerland in 1998. This procedure was first combined with high ligation of the GSV. However, several studies later showed no statistical difference between combining RFA with saphenous vein high ligation and RFA alone in terms of recurrence or symptom improvement. In fact, there is some thought that maintaining pelvic drainage via the superficial epigastric vein is beneficial, and there may be less neovascularization without the addition of high ligation. Various modifications of this technique have been used since this initial experience. The use of tumescence anesthesia was introduced in 1999, and perivenous injection of tumescence fluid under ultrasound guidance later became routine. Access of the saphenous vein also evolved into the percutaneous technique. Target treatment temperature changed to the current recommended temperature of 120°C. As mentioned earlier, prior versions of the RFA catheter required a controlled pullback technique, which has been eliminated with the ClosureFAST catheter. RFA treatment of incompetent perforator veins is now available with the ClosureRFS Stylet (VNUS Medical Technologies, San Jose, CA, USA) [6].
Results
RFA treatment of varicose veins is quite effective. The reported immediate success rate is up to 98% [6,7]. In one study using an earlier version of the Closure catheter, the success rate was 93% and absence of reflux was documented in 90% of treated limbs at 2 years. The same study reported a satisfaction rate of 95% among treated patients at 2 years [8]. The 5-year follow-up data revealed absence of reflux in 83.8% of treated limbs and vein occlusion rate of 87.2%. Those patients deemed to have anatomic failure (groin reflux or flow in a segment of the treated vein) still had a clinical improvement rate of up to 80% [9]. Proebstle and colleagues [10] published the first clinical experience with the ClosureFAST catheter and found an occlusion rate of greater than 99% up to 6 months posttreatment. Another study using the ClosureFAST showed an occlusion rate of 97% of the GSV trunk at 1 year [11].
Anatomic failures are classified into 3 types. Type I failures are those veins that never occluded and remained patent during follow-up. Type II failure involves recanalization of an initially occluded vein. Type III failures involve the presence of reflux at the groin as seen on duplex US with an occluded vein trunk. A patent accessory vein likely contributes to the groin reflux noted in the later cases. Recurrence of visible varicose veins is the risk in each situation [12].
RFA compares favorably to stripping and vein ligation. In a recent randomized trial of RFA versus high ligation and stripping, Subramonia and Lees [13] report that RFA-treated patients had less pain, greater satisfaction, and increased quality of life compared with the surgical group. The investigators used the ClosurePLUS (VNUS Medical Technologies, San Jose, CA, USA) RFA catheter system with tumescent anesthesia. The median number of days that the patients in the RFA group required to return to work was 10 days versus 18.5 days for those in the surgery group. The median number of days that patients in the RFA group took to return to normal activity was 3 days versus 12.5 days for those in the surgery group. These differences were statistically significant, favoring the RFA group. Cutaneous sensory complaints were also higher in the surgery group. The RFA procedure took longer to perform than conventional surgery, but this was thought to be due to the use of tumescent anesthesia and extensive duplex imaging.
The aforementioned findings confirmed results from earlier studies. In 2003, Lurie and colleagues [14] reported the results of a prospective randomized trial between RFA and conventional surgery for the treatment of varicose veins. The overall complication rates, including ecchymosis and hematoma formation, were lower for the RFA group compared with the conventional surgery patients. The RFA patients were also able to return to normal activity and work earlier than the surgery group. However, the paresthesia rate was more common from those patients who underwent RFA, which may have been because of lack of tumescent anesthesia use in this study. In a 2-year follow-up, the RFA group maintained better quality-of-life measurements and pain scores than the surgery group. The recurrence rate at 2 years was 14% for the RFA patients compared with 21% in the surgery patients; this difference was not statistically significant [15].
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