Chronic venous disease manifests clinically as a broad spectrum of disorders ranging from cosmetically distressing spider veins to painful varicose veins and to longstanding venous stasis ulceration. While an enormous amount of health care resources are focused on the treatment of arterial disease, venous disorders are at least 4 to 5 times more prevalent than arterial disease. In the past, saphenous vein reflux and varicose veins were treated with vein stripping surgery. Recently, minimally invasive endovenous ablation techniques of the greater and lesser saphenous veins have revolutionized treatment options. Instead of removing the saphenous vein, the current approach involves ablating the saphenous system in situ, thus stopping retrograde flow and replacing the vein with fibrous tissue. Currently, two competing technologies are used in the United States to accomplish this goal: endovenous laser ablation (EVLA) and radiofrequency ablation (RFA). As their names imply, these two catheter-based treatment modalities employ different means to generate the energy and heat used to destroy the saphenous vein. These endovenous techniques are used to ablate refluxing veins including the greater (long) saphenous vein (GSV) and its anterior saphenous branch, as well as the lesser (short) saphenous vein (LSV).
While the preoperative assessment is identical regardless of the ablation technology used, radiofrequency ablation of the saphenous system will be the focus of this review. In the United States, only one company (VNUS Medical Technologies, Inc.; San Jose, California) manufactures an RFA device approved for commercial use for the treatment of saphenous vein disease. Although the company's original ClosurePLUS RFA catheter demonstrated excellent results, it was replaced in 2007 with a newer ClosureFAST catheter that allows for more rapid, segmental ablation. Trial outcomes are expected to be similar to the previous model's results. However, data on venous ablation techniques are limited, and most RFA reports have focused on safety and efficacy of the original catheter configuration.
EPIDEMIOLOGY
Venous insufficiency results from inadequate drainage of a vein segment caused by valvular incompetence. This results in enlargement of the main trunk or a branch of the saphenous system. Recent studies suggest that 5% to 30% of the adult population have varicose veins.1 Varicose vein prevalence is greater in industrial, developed countries than in underdeveloped nations and is therefore a major medical problem in the United States and Europe. One Italian study of 30,000 subjects identified a 7% prevalence of varicose veins identified by a combination of clinical assessment and ultrasound evaluation.2 In the United States, the Framingham Heart Study reported that 1.9% of men and 2.6% of women developed varicose veins each year. Most studies identify a female predominance of varicose veins, with a US population study reporting 28% of women and 15% of men affected by this problem.3 In contrast, a UK study suggested the opposite may be true in countries outside the United States, with males affected more frequently (40%) than females (32%). While the prevalence of chronic venous disease varies depending on practice location, it remains among the most common disorders encountered in any active clinical practice environment. Risk factors associated with the development of chronic venous disease include female gender (potentially due to effects of hormones and pregnancy), family history, history of deep vein thrombosis (DVT), advancing age, obesity, and prolonged standing.1,4,5 Hispanics and whites are more commonly affected than those of African American or Asian ancestry.
Millions of Americans annually seek treatment for cosmetically distressing or symptomatic venous disorders. Approximately 5 million Americans suffer from chronic venous disease symptoms. In its most advanced clinical manifestation, venous stasis ulceration, which occurs in 1% of patients, results in the loss of 2 million workdays annually and early retirement in 12.5% of affected workers.6 In the United States and Western Europe, 1% to 2% of annual health care spending is devoted to the cost of treating venous disease, and in the United States roughly $3 billion is spent on treating venous wounds each year.7,8
MANIFESTATION OF CHRONIC VENOUS DISEASE
Venous disease patients most frequently present with small (less than 3 mm) veins visible on the surface of the skin or larger (greater than 3 mm) varicose veins that may be visible or only palpable in SC adipose tissue. Advanced symptoms may include peripheral edema, hyperpigmented or indurated skin changes, or even healed or active ulceration. The CEAP classification describes the Clinical, Etiologic, Anatomic, and Pathophysiologic components of chronic venous disease, and this clinical grading system is routinely used (Table 1).9 The patient's symptoms correspond to the severity of clinical disease. Patients with telangiectasias (spider veins) and varicose veins may have minimal complaints or be asymptomatic. Typically, patients with varicose veins complain of leg aching or heaviness after prolonged standing, swelling involving the ankle, and relief of these symptoms by leg elevation or the use of compression support. Stagnant blood in varicosities can also result in the development of superficial thrombophlebitis. Continued chronic high venous pressures in engorged surface veins in the perimalleolar area results in extravasation of red blood cells into the surrounding SC tissues. This causes hemosiderin deposition that causes hyperpigmented and fibrotic skin changes. If left untreated, these skin changes can progress to the development of venous stasis ulceration.
CLINICAL EVALUATION AND REQUIRED INSURANCE DOCUMENTATION
Telangiectasias (CEAP classification of C1) and slightly larger reticular veins are considered a cosmetic problem, and office-based sclerotherapy is the most common treatment. Varicose veins (CEAP classification of C2) may be asymptomatic even if they are impressive in their extent. Alternatively, patients may complain of local symptoms such as aching, throbbing, tenderness or pain, or more general symptoms such as itching or swelling in the malleolar region. Patients should be examined in the upright position, which makes the varices more prominent on examination. In obese patients, varicose veins may have a similar appearance to wrinkles in the fat, particularly on the thighs. Palpation will demonstrate whether these ripples are ballotable in nature (eg, varicose veins) or whether they have the same characteristics as the surrounding fat. Ankle swelling (CEAP classification of C3) should be noted, but may be minimal if the patient has been compliant with the use of compression support or if examined early in the day. Pedal pulses should be normal.
Clinicians and patients should know that most insurers require a physician-supervised prolonged trial of gradient compression hose. The duration of the trial ranges from a few weeks to 6 months. Photographs should be obtained for comparison following the completion of therapy as part of the required documentation for insurance precertification. In addition to the history, physical examination, failure to alleviate symptoms after a prolonged trial of compression support, and photographs, a careful evaluation of the venous system in the vascular laboratory is mandatory before recommending intervention with radiofrequency ablation.
As venous disease progresses, patients develop more advanced cutaneous manifestations of chronic venous hypertension. Around the malleolar regions, brown pigmentation or scaly, pruritic thickened skin will develop (CEAP classification of C4A); this can eventually result in so much accumulated damage to the skin that SC fibrosis (CEAP classification of C4B) results, causing tissues that literally feel like wood and no longer swell with edema. In its most advanced form, chronic venous disease can result in an healed or open ulcer (CEAP classification of C5/C6) in the areas of chronic cutaneous damage. These ulcers are located at or above the malleoli (Figure 1), in contrast to arterial ulcers that typically occur in the most distal areas of the foot (toes) or regions experiencing trauma (metatarsal heads, heel). Patients with advanced venous disease should be evaluated identically to those with varicose veins. Topical ointments or salves are less important than compression support with either a compliant garment (eg, stocking) or noncompliant dressing (eg, zinc oxide and calamine boot). Even if healing occurs, recurrence rates are high unless the underlying refluxing venous pathology is treated.
PREOPERATIVE VASCULAR LABORATORY EVALUATION
The gold standard for assessment of venous anatomy and physiology is duplex scanning to identify reflux, or retrograde flow, in the saphenous vein. Normally, sufficiently rapid flow in a retrograde direction results in the competent venous valves snapping shut. This process typically occurs in 0.5 seconds or less. Retrograde flow of greater than 0.5 seconds is consistent with venous insufficiency caused by valvular incompetence. Duplex documentation of prolonged retrograde flow in the greater saphenous vein, the anterior branch of the GSV, or the LSV is required before recommending radiofrequency ablation.
Testing should be conducted with the patient in an upright position. The duplex scanner utilizes the B-mode image to identify the venous segment to be interrogated while the Doppler is used to record the direction and duration of flow. Various techniques are used in order to produce sufficient retrograde flow velocities to induce valve closure, including the Valsalva maneuver, proximal manual compression, or the use of distally placed rapidly deflating cuffs. The technologist typically interrogates the femoral, popliteal, and greater and lesser saphenous veins. A standard venous duplex scan of the deep venous system is also obtained with the patient in a supine position to rule out the presence of deep vein thrombosis. Lastly, vein mapping to note the size and course of the greater and lesser saphenous veins is conducted. Typically, these studies identify a normal deep venous system with no valvular reflux and the presence of a generous sized, refluxing greater or lesser saphenous vein. Even if reflux or chronic postphlebitic changes in the deep veins are identified, treating the refluxing superficial veins has been shown to improve or resolve associated deep venous hemodynamic abnormalities.10
RADIOFREQUENCY ABLATION PROCEDURE
After obtaining insurance preapproval, most patients can be treated with RFA in an office or an outpatient setting. Patients typically receive a preoperative antibiotic (typically an oral cephalosporin) and a mild sedative (eg, 5-10 mg of diazepam [Valium, Valrelease]). Next, a sterile ultrasound probe is used to trace the GSV from the sapheno-femoral junction distally to a point where venous access will be obtained, typically between the midcalf and knee. For LSV ablations, the patient can be placed in a lateral decubitus or prone position; in this case, the lesser saphenous vein can be identified at the sapheno-popliteal junction and accessed in the midposterior calf. Using ultrasound guidance and local anesthetic, percutaneous access to the vein is obtained. A modified Seldinger technique is used to place a 7Fr sheath into the vein (Figure 2). After the wire is removed, the treatment catheter is introduced and advanced under ultrasound guidance until its tip nears the sapheno-femoral venous junction. Gentle advancement of the catheter is important in order to minimize patient discomfort. Most patients will note little or no sensation if the catheter is atraumatically advanced. If difficulty occurs advancing the catheter, a long guidewire may aid passage through a tortuous segment.
Ultrasound is used to identify the most proximal tributary into the saphenous vein near the sapheno-femoral junction. Typically, this is the superficial epigastric branch, and color Doppler is used to demonstrate flow through the epigastric branch and into the saphenous system, then into the femoral vein. The tip of the catheter is bright under ultrasound with an echolucent shadow behind it and is easily identifiable (Figure 3). The tip of the treatment catheter is positioned 1.5 to 2 cm distal to the sapheno-femoral venous junction and to the epigastric branch, and the position is noted on markers on the catheter. Tumescent anesthesia is then infiltrated into the perivenous tissue under ultrasound guidance with the needle tip adjacent to the vein and below the superficial SC fascia. A solution of tumescent anesthesia that consists of lidocaine, epinephrine, and sodium bicarbonate in a 500 mL bag of saline is introduced liberally into the perivenous space. This solution is injected manually through a one-way syringe (Figure 4) or via a foot-actuated pump. The tumescent solution tracks along the vein for several inches, with the process repeated until the entire vein is surrounded with the tumescent anesthetic solution (Figure 5). If injected below the SC fascia in the perivenous space, this process causes the patient little or no discomfort. The tumescent anesthetic serves multiple purposes. First, the lidocaine functions as an anesthetic that renders the ablation painless. Second, the epinephrine induces venospasm to assist with apposition of the treatment catheter and the vein wall. Third, the solution serves as a heat sink, protecting surrounding tissues from thermal injury and, lastly, the solution compresses the vein around the treatment catheter. Important adjacent structures, including the overlying skin and the saphenous and sural nerves, must be moved at least 1 cm away from the catheter tip by infiltration of tumescent solution into the perivenous space.
After confirming adequate tumescence along the segment to be ablated, the patient is placed in Trendelenburg position and, before ablation begins, the tip of the catheter is reexamined to confirm it has remained in the desired location. The catheter is connected to the radiofrequency generator, and treatment is initiated while the ultrasound probe applies gentle compression to the overlying skin, compressing the treatment element against the vein wall and limiting the flow of blood into the segment being ablated. The system rapidly heats the 7-cm-long treatment segment of the catheter to 120°C and monitors power consumption, power, and time remaining in each treatment cycle. Each treatment cycle lasts 20 seconds, and the most proximal venous segment is treated twice. Patients experience no pain during ablation.
The catheter has markings in 7-cm increments, and after ablating the most proximal region, the catheter is withdrawn 7 cm and the process is repeated in single cycles until the entire desired portion of vein has been ablated. A completion ultrasound should document flow in the epigastric vein, saphenous vein stump, and femoral vein, as well as the absence of flow in the treated portion of vein. The vein will typically be difficult to identify because it no longer contains blood, and the ablated vein segment will thus be indistinguishable from the surrounding SC tissue. The sheath is then removed and a brief period of manual compression at the access site is all that is required to obtain hemostasis. Finally, the patient is placed in compression support and discharge instructions are provided. No postoperative pain medication is usually required, and patients are instructed to ambulate immediately and resume normal activity the following day. A brief period of postoperative compression is recommended, from 1 to 7 days depending on the treating physician's preference.
POSTOPERATIVE FOLLOW-UP
Since the proximal extent of the ablation procedure is in proximity to the deep venous system, one potential complication is the development of thrombus in the stump of the saphenous vein. The thrombus may propagate into the adjacent femoral venous segment (resulting in a femoral deep vein thrombosis) with the attendant potential sequelae of pulmonary embolism or postphlebitic syndrome. To monitor for these complications, postoperative ultrasound surveillance is routine. Our preference is for two ultrasounds: the first performed 24 to 72 hours after the procedure and the second 1 week later. The reported incidence of DVT after endovenous ablation varies between 0% to 16%, with most series reporting deep vein thrombosis rates in the lower half of that range. Acute thrombus in the stump of the saphenous vein without propagation into the femoral vein is not uncommon. Treatment recommendations for this problem vary and may include repeat ultrasound surveillance alone, a brief course of outpatient anticoagulation, or long-term anticoagulant therapy. No single treatment strategy has been documented to be optimal.
Patients often experience minimal postoperative discomfort but will notice mild to moderate bruising and a sensation of tightness as the saphenous vein is replaced by fibrotic tissue. Acetaminophen or an NSAID is recommended to alleviate postoperative discomfort. These symptoms are short-lived and typically resolve within 1 to 3 weeks after the procedure.
OUTCOMES
Radiofrequency ablation reports published prior to 2007 present outcomes of the original ClosurePLUS catheter that was subsequently replaced by the newer ClosureFAST device (VNUS Medical Technologies, Inc.; San Jose, California). An initial European trial of the ClosureFast device demonstrated a 98.6% rate of successful ablation at 6 months in 252 treated GSVs in 194 patients,12 and a 96.9% occlusion rate at 1 year.13 No patients experienced DVT or thermal skin injury. The most common complications reported were ecchymosis in 6.4% of patients and localized paresthesia in 3.2%. Seventy percent of patients required no postoperative analgesics. Another study documented similar outcomes, with a 96.2% occlusion rate after 1 year. A company-supported, randomized trial reported that ClosureFAST RFA was superior to 980-nm endovenous laser vein ablation and had less postoperative pain, ecchymosis, and tenderness in the first 2 weeks after radiofrequency ablation.11
CONCLUSION
RFA and laser ablation of the greater saphenous vein are minimally invasive procedures with excellent early- and midterm outcomes for patients with CEAP class 2 through 6 disease and duplex documented saphenous reflux. Postoperative pain following radiofrequency ablation treatment is minimal, return to full activity is prompt, and serious postoperative complications are rare. Clinical
care providers should be aware of a new generation of treatments that have replaced older, more painful vein stripping procedures, and should consider referring patients with symptomatic venous complaints for RFA or similar treatment options to experienced providers of these procedures. jaapa
Susan Rubin has worked in vascular surgery and cardiothoracic surgery. Brian Rubin is a professor of surgery, Washington University School of Medicine, St Louis, Missouri. The authors have indicated no relationships to disclose relating to the content of this article.
REFERENCES
1. Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005;15(3):175-184.
2. Cesarone MR, Belcaro G, Nicolaides AN, et al. "Real" epidemiology of varicose veins and chronic venous diseases: the San Valentino Vascular Screening Project. Angiology. 2002;53(2):119-130.
3. Criqui MH, Jamosmos M, Fronek A, et al. Chronic venous disease in an ethnically diverse population: the San Diego Population Study. Am J Epidemiol. 2003;158(5):448-456.
4. Jawien A. The influence of environmental factors in chronic venous insufficiency. Angiology. 2003;54(suppl 1):S19-S31.
5. Criqui MH, Denenberg JO, Bergan J, et al. Risk factors for chronic venous disease: the San Diego Population Study. J Vasc Surg. 2007;46(2):331-337.
6. Da Silva A, Navarro MF, Batalheiro J. The importance of chronic venous insufficiency: various preliminary data on its medico-social consequences. Phlebologie. 1992;45(4):439-443.
7. McGuckin M, Waterman R, Brooks J, et al. Validation of venous leg ulcer guidelines in the United States and United Kingdom. Am J Surg. 2002;183(2):132-137.
8. Ruckley CV. Socioeconomic impact of chronic venous insufficiency and leg ulcers. Angiology. 1997;48(1):67-69.
9. Eklöf B, Rutherford RB, Bergan JJ, et al; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004;40(6):1248-1252.
10. Walsh JC, Bergan JJ, Beeman S, Comer TP. Femoral venous reflux abolished by greater saphenous vein stripping. Ann Vasc Surg. 1994;8(6):566-570.
11. Almeida JI, Kaufman J, Göckeritz O, et al. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009;20(6):752-759.
12. Proebstle TM, Vago B, Alm J, et al. Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: first clinical experience.
J Vasc Surg. 2008;47(1):151-156.
13. Creton D, Pichot O, Sessa C, Proebstle TM. Radiofrequency-powered segmental thermal obliteration carried out with the ClosureFast procedure: results at 1 year. Ann Vasc Surg. 2010;24(3):360-366.