Laser Treatment Of Varicose Veins Produces Better Outcomes Than Surgery Or Other Therapies Suggests Long-Term Research

1/22/2003

From: Sonja R. Sorrel or Julie Semancik for the International Symposium on Endovascular Therapy, 312-558-1770, or from Jan. 19-23, 305-674-4782

MIAMI BEACH, Fla., Jan. 22 -- Four years after the introduction of laser therapy for the treatment of varicose veins, studies suggest the minimally invasive treatment is better than surgery, the current standard of care. Two-year follow-up results on 97 patients treated with endovenous laser treatment (ELVT) are being presented today at the 15th Annual International Symposium on Endovascular Therapy.

In the longest follow-up study of laser therapy for varicose veins to date, Robert Min, M.D., director of the Cornell Vascular Weill Medical College of Cornell University, New York, reports that varicose veins recurred in only 6 percent of patients treated with the laser compared to 10 percent or more of patients who undergo surgery and other procedures. The laser therapy seals painful, swollen veins shut by delivering laser energy to the blood vessel lining. "It's one thing to say that varicose veins are still closed two months after treatment. It's much more powerful to say that we've been doing this for several years -- our longest follow-up is 3.5 years -- and our results are better than surgery," Dr. Min said.

Swollen, raised and often twisted and bulging varicose veins along the back or inside of the leg afflict about half of women 50 or older in the United States and about 10-15 percent of men. In addition to being unsightly, varicose veins may produce discomfort, swelling, leg muscle fatigue, throbbing and cramping at night, and itching or burning of the skin on the leg and around the ankle. Varicose veins continue to enlarge and worsen over time. When they become severe, varicose veins can lead to chronic venous insufficiency, a condition that occurs when blood does not completely return to the heart from the veins and that may precipitate leg swelling or alteration of the skin.

In the study, 414 limbs in 364 patients were treated in a 37-month period with 810 nm diode laser energy delivered intraluminally. Patients were evaluated clinically with ultrasound at one week, one month, six months, one year and then yearly to assess treatment efficacy.

Two-year follow-up was obtained in 97 limbs. Ninety-one of 97 limbs (94 percent) followed up to a minimum of two years have remained closed. There have been no skin burns, paresthesia (pricking or tingling of the skin), incidences of deep vein thrombosis or other adverse reactions.

The most common treatment for varicose veins that caused symptoms has been surgical ligation and stripping, in which the veins are tied shut and completely removed from the leg. During the surgical procedure, which requires general anesthesia, surgeons make multiple incisions, often leaving scars, and frequently can not avoid interfering with small branches of sensory nerves, causing some areas of skin to feel numb or to have a burning sensation. Surgery also does not completely eliminate varicose veins in up to 10 percent of patients.

Less invasive procedures that inject a chemical solution (sclerotherapy) or use radiofrequency energy (radiofrequency ablation) to seal veins shut have been developed in recent years. However, the rate of recurrence of varicose veins after these treatments is as high as 50 percent in patients treated with sclerotherapy and up to 10 percent in patients undergoing radiofrequency ablation, Dr. Min said. With sclerotherapy, the chemical solution may cause side effects, such as inflammation or pigmentation along the length of the treated vein.

In addition to its low recurrence rate, EVLT has other benefits. It is a procedure that can be done in a physician's office under local anesthesia with lidocaine - the same anesthetic used by dentists. It also requires only a small incision and has a short recovery period.

"We encourage people to go back to their normal activities right away," Dr. Min said.

Dr. Min, who developed EVLT, has performed more than 500 treatments on varicose saphenous veins, the most common site of significant varicose disease. The procedure involves injecting a local anesthetic under ultrasound guidance, inserting a catheter and laser fiber through a small skin incision and continuously delivering laser energy along the entire length of the blood vessel wall.

"You don't need a big access site to introduce the laser fiber and deliver a sufficient amount of targeted heat to close the vein, which is the ultimate goal of treatment," Dr. Min said.

Considered to be the premier meeting on endovascular therapy, ISET celebrates 15 years of innovation in education. More than 1,100 physicians, researchers and industry professionals from around the world attend the meeting each year. The meeting is well known for its live patient demonstrations that focus on the most recent procedures and devices for treating cardiovascular disease as well as for promoting a multidisciplinary approach to the diagnosis, treatment and prevention of endovascular diseases. ISET is presented by the Miami Cardiac & Vascular Institute and cosponsored by the Society of Interventional Radiology.

AT A GLANCE:

-- After more than two years -- the longest follow-up period to date -- laser treatment to seal varicose veins had a lower recurrence rate than surgery or other types of treatment.

-- Endovenous laser treatment can be done in a physician's office under local anesthesia and requires only a small nick in the skin.

-- Patients can return to normal activities immediately after treatment.

------ The 2003 ISET news releases are available online at http://www.pcipr.com/newsroom/ISET.



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