Steam Offers Novel Approach to Treating Varicose Veins

SEOUL, SOUTH KOREA – Steam ablation of varicose veins appears to be a safe, effective, and relatively simple new endovascular thermal therapy with excellent patient acceptance, according to Dr. Martino Neumann.

"Maybe water will be the future for your practice," said Dr. Neumann. He presented the results of a pilot study of steam ablation at the World Congress of Dermatology.

Steam may offer a safer alternative to endovascular laser ablation of saphenous varicose veins. "If you look at your laser probe after treating a vessel, you can see strong carbonization and slight damage to the tip of the probe. This foreign material may stay within the body," said Dr. Neumann of Erasmus University Medical Center, Rotterdam, the Netherlands.

Endovascular laser ablation of varicose veins has become a popular procedure in recent years. But it results in temperatures of 600°-1,000° degrees C, causing blood to literally boil and carbonize. In contrast, steam ablation is performed at a temperature of 120° C. The pulsed steam is released under pressure into the blood vessel through two holes near the tip.

Steam ablation utilizes a 1.2-mm highly flexible catheter which is introduced directly through the puncturing needle without need for a sheath or guidewire. This makes for a simpler and safer procedure than with the stiff glass fibers used in laser ablation, said Dr. Neumann.

The pilot study entailed steam ablation of 17 great saphenous veins and 3 small saphenous veins in 19 patients. The mean treated vessel length was 25 cm, with an average of 50 steam pulses or puffs administered per treated vein. Each treated vein utilized roughly 2 mL of sterile water. The procedure was conducted on an outpatient basis under local tumescent anesthesia.

Nine patients had ecchymoses at the puncture site, and one had a transient superficial phlebitis. There were no cases of deep vein thrombosis, infection, or any other serious side effects.

All treated veins were occluded upon ultrasound examination 1 week post treatment. At 6 months follow-up, ultrasound examination showed 13 of 20 veins were completely occluded; the other 7 showed a small segment of recanalization that was not clinically relevant.

The investigators continue to search for the optimal dose of steam, expressed as puffs per treated centimeter of vein, to eliminate any recanalization.

Median patient satisfaction with the treatment was 9.25 on a 0-10 scale. Median maximal pain after the procedure was 1 on a 10-point scale.

Based upon the favorable pilot study results, a definitive head-to-head comparative study is underway. Approximately 250 patients at three Dutch medical centers were randomized to steam ablation or laser ablation; participants are now in the follow-up phase of the trial.

Studies in sheep demonstrated that the mechanism of steam ablation involves endothelial destruction, thickening of the vessel wall with fibrosis and inflammation, and alteration of collagen and elastic fibers in the media. The diameter of treated vessels decreased over time, with a mean 56% reduction 3 months post treatment.

If steam ablation is to make substantial inroads on endovascular laser ablation, it will have to be on the basis of safety, cost, and patient and operator satisfaction. Laser ablation is tough to beat on the basis of efficacy.

In a meta-analysis carried out by Dr. Neumann and coinvestigators, the 5-year success rate with endovascular laser ablation of saphenous varicose veins was 95%, compared with 80% for nonsegmental radiofrequency ablation, 74% with ultrasound-guided foam sclerotherapy, and 76% with traditional surgery involving ligation and stripping of the veins.

The steam ablation studies were conducted using the Steam Vein Sclerosis, or SVS, system manufactured by CERMA, a French company. Dr. Neumann declared having no relevant financial relationships.