Treating Varicose Veins
Today’s minimally invasive treatments are poised to replace stripping and surgery.
At least 25 million Americans suffer from venous disease secondary to superficial venous insufficiency. This problem is 10 times more prevalent than peripheral arterial occlusive disease. Recently developed minimally invasive, effective, and durable endovenous catheter-based treatments have revolutionized how venous reflux is treated. These innovations will likely replace vein stripping (the standard surgical treatment) in the not too distant future. Once a good understanding of the pathophysiology is gained, the interventional radiologist’s skill set is superbly suited to treating this disease with these new technologies.
MORE THAN SKIN DEEP
Although often thought of as a strictly cosmetic concern, varicose veins associated with superficial venous insufficiency cause significant clinical problems. The disease is more common in women (2:1) and in middle-aged to elderly people. Women frequently develop superficial venous disease during pregnancy, and the condition usually worsens in severity with future pregnancies. Approximately 50% of the population over 50 years old has some form of this disorder. The specific age distribution of patients who would benefit from this procedure is: 18 to 39 (28%), 40 to 59 (48%), and 60 and over (24%).
There is a large genetic component to this disease, and it is common for multiple members of a given family to be affected. In addition, people with lifestyles or jobs that require them to stand for prolonged periods are also predisposed. Patients usually present with aching, burning, itching, or throbbing legs, especially after long periods of standing or sitting. Symptoms can also be exacerbated during menses. Varicosity of veins due to venous insufficiency is a progressive disease; left untreated, the condition can lead to swollen ankles, skin color changes, and skin ulcers.
UNDERSTANDING THE PROBLEM
The condition is primarily due to nonfunctioning venous valves or a diseased vein wall in the superficial leg veins, most commonly the greater saphenous vein (GSV) (Figure 2). The abnormal condition allows blood to pool in the legs rather than returning efficiently to the heart. This pooling causes varicose veins to form and sometimes gives rise to clinical symptoms. A good analogy is that of a leaking tube and a waterfall. Blood leaks from the well-supported deep venous system to the poorly supported superficial system and then cascades down the leg due to gravity. The blood then tries to find its way back into the deep system by creating a varicose vein. Once it has returned to the deep system, the blood goes back up the leg to the point where the leak occurred and the whole process starts again.
In order to effectively treat the problem, the leak or leaks have to be found and sealed. The deep venous system, which is responsible for draining 90% of blood in the leg, is usually not affected by this disease. The disease is diagnosed and classified in severity by history and physical examination. Once suspected, a detailed, color-duplex ultrasound examination is performed to evaluate the superficial and deep systems in order to plan treatment. The duplex system excludes chronic or acute DVT, which for all practical purposes may contraindicate performing this procedure.
NEW TOOLS FOR NEW TREATMENTS
The new catheter-based treatments for venous disease secondary to superficial venous reflux include endovenous ablation with FDA-approved lasers or radio frequency energy. The diode laser systems include ELVS (Endovascular Laser Venous System 810/980nm, AngioDynamics, Inc., Queensbury, NY), EVLT (Endo Venous Laser Treatment 810nm, Diomed, Inc., Andover, MA), or the ELAS 940nm (Dornier MedTech America, Inc., Kennesaw, GA). The Closure system from VNUS Medical Technologies, Inc. (San Jose, CA) is a radiofrequency energy ablation device. All of these systems work by imparting a heat injury to the vein wall; the resultant inflammatory reaction seals the leaking vein shut. All of these new technologies are approximately 90% effective with VNUS having the most extensive long-term data, 3 years versus 2 for the laser-based devices.
THE ENDOVENOUS APPROACH
Endovenous GSV ablation is an outpatient procedure that is performed in a fluoroscopy or procedure room with or without conscious sedation. Patients are selected using similar criteria for those that presently undergo greater saphenous vein stripping. Using ultrasound guidance, the physician enters the GSV at or near the knee using a 21-gauge needle. There is no cut down or tissue dissection; the physician makes a 2-mm incision to allow for easy passage of the catheter and sheath. Once access to the greater saphenous vein is accomplished, a special catheter is passed up the vein to the sapheno-femoral junction. The position of the catheter is visualized using ultrasound. Once the operator is satisfied with the catheter position, a tumescent anesthesia solution is instilled in the subcutaneous peri-vein/catheter complex space. The device is then turned on and slowly pulled down the length of the GSV until it almost reaches the entrance site, at which time the procedure is terminated.
Patients recover for approximately 45 minutes using our outpatient day ward and are instructed to wear compression stockings for a few days (Figure 3). There is little to no postprocedure pain and patients are able and encouraged to ambulate immediately. In addition, bleeding complications are not present and the incidence of paresthesia is less than that of stripping. There is a 0.6% risk of blood clot formation, which is less than surgery and is easily treated on an outpatient basis.
SURGICAL STRIPPING AND LIGATION
Vein stripping and ligation has represented the gold standard for treating saphenous vein reflux with approximately 1 million operations performed annually throughout the world. The operation involves the surgical removal of an incompetent GSV by means of two incisions and a mechanical “stripper.” The surgeon makes a 3- to 4-inch incision at the groin and the veins at the sapheno-femoral vein junction are thoroughly dissected and tied off. The surgeon then passes the stripper through the GSV to an area at or just below the knee. Another 1- to 2-inch incision is then made near the knee and the stripper and greater saphenous vein are pulled out through the lower incision. Small side branches are simply ripped from the greater saphenous vein and close down on their own.
Although generally effective, the operation can lead to complications including postoperative pain, bleeding, wound infections, deep vein thrombosis, nerve damage, and poor cosmetic outcomes. In addition, patients routinely require 3 days of bed rest and significantly prolonged recoveries compared to endovenous ablation. The surgery is accompanied by a higher incidence of varicose vein recurrence and neovascularization following stripping than endovascular repair. Furthermore, vein stripping requires an operating room and general anesthesia. In general, surgical stripping is an operation that patients are weary of, and it is not uncommon for people to choose to live with their varicose veins rather than undergo this procedure.
A GROWING MARKET SHARE
Endovenous therapies currently have approximately a 7% share of this market. This number will probably grow considerably in the next 5 years as these techniques gain wider acceptance. In addition, the minimally invasive nature and quicker recovery times associated with these techniques will likely have patients in search of physicians who can perform them.
Physicians interested in performing endovenous GSV ablation should also be able to carry out ambulatory phlebectomy and ultrasound-guided sclerotherapy. These adjunctive procedures may be performed in the same or a later sitting, depending on physician preference. These procedures remove the large, visible, or persistent varicose veins that remain in approximately 50% of patients following endovenous ablation. To return to the leak and waterfall analogy, the endovenous procedure plugs the main leak and the adjunctive procedures wipe up the left over water. These adjunctive procedures are relatively easy for the interventional radiologist to learn and are an important element in treating this patient population. Training sessions for all of these techniques are available at vein centers throughout the country.
AN EXCITING OPPORTUNITY FOR RADIOLOGISTS
This is an exciting opportunity for interventional radiologists to now use their catheter skills to effectively treat a disease that was previously the domain of the surgeon. To gain a better understanding of the disease process and treatment algorithms, visit www.phlebology.org. Corporate Web sites also offer information; visit www.elvslaser.com; www.evlt.com, www.dornier.com, or www.vnus.com. Interested practitioners can also read the comprehensive text Vein Diagnosis and Treatment, by Weiss, Feied, and Weiss.
GSV ablation can be safely performed in a hospital or private clinic setting and represents a quantum leap forward compared to vein stripping. In addition, these new endovenous procedures represent a potentially large growth opportunity for the motivated interventionalist who wants to learn about the disease and its treatment algorithms.
Neil Denbow, MD, is Assistant Professor in the Section of Vascular and Interventional Radiology at Yale University in New Haven, Connecticut. Yale is a training center for ELVS and has trained people for VNUS in the past. Dr. Denbow may be reached at (203) 785-7026; firstname.lastname@example.org.