SAN DIEGO – Foam sclerotherapy alone was just as effective as ultrasound-guided foam sclerotherapy for the treatment of great saphenous vein reflux, results from a single-center study showed.
Dr. Takashi Yamaki, a vascular surgeon, and his associates in the department of plastic and reconstructive surgery at Tokyo Women’s Medical University conducted a randomized study between January and July 2010 in which 51 limbs in 48 patients were treated with ultrasound-guided foam sclerotherapy and 52 limbs in 49 patients were treated with foam sclerotherapy alone.
Patients in the combined-treatment group received less than 0.5 mL of 1% polidocanol foam per injection to minimize any foam migration beyond the target vein, said Dr. Yamaki at the annual meeting of the American Venous Forum.
Patients in the foam-only treatment group received more than 0.5 mL of 1% polidocanol foam per injection, but the amount never exceeded 1.0 mL.
The researchers conducted ultrasonographic inspection of the foam in the greater saphenous vein for 5 minutes before compression was applied. They also conducted postsclerotherapy surveillance at 1, 3, and 6 months. The study’s primary end point was elimination of greater saphenous vein reflux at 6 months.
The mean age of patients was 66 years, and 71% were female. There were no differences between the groups in terms of CEAP clinical classification (which is based on clinical severity, etiology or cause, anatomy, and pathophysiology) or venous clinical severity scores.
Dr. Yamaki reported that the mean greater saphenous vein diameter was 0.6 cm in the combined-treatment group and 0.57 cm in the foam-only treatment group, a difference that was not significant. The mean injected volume of foam for varicose tributary veins was significantly lower in the combined-treatment group than in the foam-only group (3.9 mL vs. 5.8 mL, respectively). However, the mean total amount of injected foam was significantly higher in the combined-treatment group than in the foam-only group (6.5 mL vs. 5.8 mL).
Ultrasonic evaluation revealed complete spasm of the greater saphenous vein in 73% of limbs that underwent combined treatment, compared with 56% of limbs that underwent foam-only treatment, a difference that was not significant.
At 6 months the researchers observed absence of reflux in 59% of limbs that underwent combined treatment, compared with 71% of limbs that underwent foam-only treatment, a difference that was not significant.
No serious complications occurred in either group.
"Further studies are required in order to define the predictive factors for successful outcome, especially in patients with uncomplicated varicose veins, including factors such as foam production, the optimal volume of foam, the use of physiologic gases, injection techniques, and the optimal period of use of compression stockings," said Dr. Yamaki.
Zeria Pharmaceutical provided the 1% polidocanol used in the study. Dr. Yamaki said that he had no relevant financial disclosures.