|
|
For other articles and previous issues click here. July 18, 2005 Your
Sore Veins Less-invasive alternatives to varicose vein surgery are giving sufferers options that are less costly and potentially more effective. “A remarkable evolution.” That’s how Rodney Raabe, MD, medical director of the radiology department at Sacred Heart Medical Center in Spokane, Wash., describes what has happened with medical treatment for varicose veins. For at least 45 years, the standard treatment was surgical ligation or vein stripping, a procedure done under general anesthesia that can be painful and often has a long recovery time. In addition, patients who undergo surgery have approximately a 25% recurrence rate. In the past five years, less-invasive procedures have been developed for treatment of improperly functioning veins, which are often painful and ugly. One of the newest and most promising nonsurgical treatments is endovenous laser ablation, an outpatient procedure in which the physician applies laser energy to the inside of the vein to seal it and prevent blood flow. The energy is delivered through a fiber optic catheter inserted in the vein under ultrasound guidance. The laser treatment is more effective than a surgical approach and has medical and economical benefits, says Robert J. Min, MD, MBA, an interventional radiologist and vice chairman of radiology at the Weill Medical College of Cornell University in New York City who pioneered the laser technique. Endovenous laser ablation, which received FDA approval in 2002, can be done as an outpatient procedure with local anesthesia in approximately one hour. “Patients walk in, have the procedure, and walk out,” Raabe says. Saphenous Vein In April, at the 30th annual scientific meeting of the Society of Interventional Radiology in New Orleans, Min presented a study of more than 200 limbs of patients showing a 96% success rate for treating the non-great saphenous veins with endovenous laser ablation. His is the first large study to investigate treating faulty nonsaphenous veins with laser ablation and shows that the results are superior to those reported for traditional treatments, including surgery. Laser ablation is highly effective and relief from symptoms is immediate. Furthermore, it has a recurrence rate of less than 5%, according to its proponents. The potential market for endovenous laser ablation is quite large, Min says. Many people who are unwilling or unable to undergo traditional treatment may be candidates for laser therapy. Raabe says many of his patients are nurses or teachers who say they would have been treated years earlier if such a procedure had been available. Varicose veins occur when valves in the vein meant to keep blood from flowing downward with gravity become weak and do not close properly. They allow blood to flow backward or reflux. The veins dilate under pressure and can become elongated, ropelike, bulged, and thickened. Varicose veins occur most commonly in the legs. The affected veins can look blue, swollen, and stretched or kinked. Not all patients experience symptoms, but those who do usually feel throbbing, aching, and/or a heaviness in their legs. Leg fatigue, swelling, and itching near the damaged veins are also common. Symptoms typically worsen as the day progresses and after prolonged periods of standing. In more severe cases, venous insufficiency and reflux can cause skin discoloration and painful skin ulceration, which is difficult to treat. People without visible varicose veins can still have symptoms. Broad Patient Population Vein stripping surgery requires tying off the faulty veins and pulling them through a series of small incisions in the skin. The problem with surgery is that it is painful, Raabe says. “You are off from work for six weeks, you have to go under general anesthesia, and there is about a 20% to 25% recurrence rate when you look at it long-term, which is not good.” Surgery is also costly. “When you look at typical hospital charges, it’s usually in the $14,000 range for surgical stripping when you count the anesthesia, even if it’s done as a same-day procedure,” Raabe says. Another surgical option is ambulatory phlebectomy, which is less invasive than stripping and ligation. A phlebectomy hook is used to extract the veins through tiny skin incisions or punctures that need no stitches. Although useful to treat some branch veins, phlebectomy cannot be used to treat the saphenous vein or other sources of significant reflux in the trunk of the body. Less-Invasive Options In 1999, RFA became the first endovenous procedure to be approved by the FDA. It has a solid core of scientific literature to support its effectiveness, says Robert F. Merchant, Jr, MD, FACS, a vascular surgeon at the Reno Vein Clinic & Surgery Center in Nevada. Like laser ablation, RFA is performed by placing a catheter into the abnormal vein that delivers radio frequency heat energy to the vein wall, causing it to collapse, close, and seal. Once the vein is sealed, healthy veins take over and redirect the blood flow. RFA is performed with a local anesthetic in a physician’s office. Since August 1999, Merchant has performed more than 700 RFAs using the Closure procedure manufactured by VNUS Medical Technologies, Inc. of San Jose, Calif., to treat venous reflux disease. He prefers it to laser ablation. At February’s American Venous Forum Meeting in San Diego, Merchant reported on a multicenter study that found 87% of 117 limbs treated with the Closure procedure remained occluded at the five-year mark. “In the last few years, the technology has improved significantly, so we have an even better success rate,” Merchant says. “We have about 99% closed successfully now within the first week with just one treatment.” Merchant says data is not yet available on RFA treatment of small saphenous veins. “We’re not sure it is quite as successful because the numbers are so small,” he says. However, he adds, it shows promise. Mel Rosenblatt, MD, an interventional radiologist at Connecticut Image Guided Surgery in Milford, performs both radio frequency using the Closure procedure and laser endovenous ablation. Rosenblatt has found that Closure, although an effective device, has a somewhat higher failure rate than laser ablation. However, he says, the increased effectiveness of laser comes at a price. With laser, recovery is often longer and more painful due to significant bruising. The problem, Rosenblatt explains, “is that you get a lot more burn injury to the vein with a laser, and so you can get a lot more inflammatory response. I’ve had some patients with some wicked responses.” Anti-inflammatory medication generally helps solve the problem, but not always, he says. If there is a battle in the physician world between the two technologies, laser is winning, Rosenblatt says. The reason is twofold: the laser is a faster procedure and its long-term effectiveness is greater. “The one thing we would like to figure out is how to make it less painful afterward,” Rosenblatt says. “If we took away the recovery pain, I think many physicians would prefer to use laser.” Rosenblatt usually leaves the decision to his patients. However, he finds that Closure is very effective in veins less than 1 centimeter in diameter and results in almost no pain during recovery. Veins larger than 1 centimeter have a greater chance of reopening when treated with the Closure procedure. “That’s why I lean toward laser in patients with larger-diameter veins,” he says. Cost may also be an issue for some physicians, Rosenblatt says. The retail price of the Closure catheter is $700 to $800; the laser roughly $300 to $400. “Nowadays most physicians are doing these procedures in their office, which means the cost of the equipment comes out of their pocket, so there can be a cost incentive to laser,” he says. Most insurers will cover the RFA or laser procedure if there is a medical need for symptom relief. New codes and payment rates were contained in the Medicare Program Final Rule issued in November. Neither procedure will be covered if it is done purely for cosmetic reasons. “Two years ago, most insurance didn’t cover laser ablation,” Raabe says. “Now I’d say 90% do.” Medicare requires that patients wear compression stockings for at least three weeks to see whether they help before it will approve the laser procedure, Raabe says. “Different insurance companies have different policies as to whether you need to try the stockings first or not.” If the condition improves with compression stockings, it suggests that the symptoms will be significantly improved or completely go away after the ablation procedure, Raabe says. After the laser procedure, patients must wear compression stockings for one to three weeks. The stockings help the leg heal. Patients’ legs may be bruised for a week or two afterward, which is normal and will go away, Min says. Patients are not restricted from doing normal activities as they would be if they had surgery. “This is a strictly office procedure, done under local anesthesia. Patients feel a tiny skin prick during the procedure and can go back to work right away without any down time,” Min says. Eventually, the ablated vein shrivels up. “You can’t see it or feel it,” Raabe says. “Most times you won’t even see it with imaging studies.” Most anyone with veins requiring treatment can undergo the laser ablation procedure safely, Min says, with a few exceptions, including those who are pregnant. However, the ugly veins associated with pregnancy tend to disappear on their own after delivery. The laser procedure also cannot be done on veins that have a lot of sharp turns or are too short. “You want the segment of the vein to be at least a few centimeters,” Min says. Short veins are more easily treated with surgery. People are always asking Min, who sold a patent for the procedure to Diomed of Andover, Mass., what can be done to make it better. His answer is not much. “Obviously, there are nuances for the procedures, and I’ve done some things to continually improve the procedure,” he says. “But my argument is you’re taking a procedure that is nearly 100% effective now with virtually nonexistent complications if done properly. It’s pretty hard to improve on that.” — Beth W. Orenstein is a freelance medical writer and regular contributor based in Northampton, Pa. |
 |
 |