SAN DIEGO – At 5 years of follow-up, patients who had ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation had equally good clinical results compared with patients who underwent surgical treatment of varicose veins, based on a randomized controlled trial.
"Since surgery may not provide a definitive treatment, foam sclerotherapy could be offered like a dental care treatment model: treating as and when the problem appears," Dr. Evi Kalodiki said at the annual meeting of the American Venous Forum.
Dr. Evi Kalodiki
Dr. Kalodiki, a vascular surgeon at Ealing Hospital and Imperial College, London, and her associates evaluated 82 legs that were treated in 73 patients. The mean age of the patients was 48 years, and 75% were female. The researchers randomized the cases to two treatments: 39 legs underwent saphenofemoral ligation, stripping, and multiple phlebectomies under general anesthesia (surgery group) and 43 underwent saphenofemoral ligation under local anesthesia with concurrent foam sclerotherapy (foam group).
Assessments included ultrasound, the CEAP (clinical, etiologic, anatomical, pathophysiologic) classification, the Venous Clinical Severity Score, the Aberdeen Varicose Veins Questionnaire (AVVQ), and the Short Form 36 Health Survey (SF-36). Follow-ups were conducted annually until a median of 5.12 years.
Dr. Kalodiki reported that the CEAP classification was similar for the two groups, as was the percentage of legs that required additional foam sessions (40% of legs in the surgery group, with a mean volume of 11 mL for each case, vs. 48% of legs in the foam group, with a mean volume of 9 mL for each case).
Preoperative Venous Clinical Severity Scores (VCSS) were similar for the two groups (median of 5 in the surgery group vs. 4 in the foam group), as were post-treatment VCSS, at a median of 1 in each group. Median changes in VCSS from baseline to 5 years were similar in the two groups: 3 in the surgery group vs. 3.5 in the foam group. Absolute VCSS values at 5 years were a median of 1 in each group.
The AVVQ score also improved in both groups. In the surgery group, the median AVVQ score improved from 16.32 preoperatively to 8.94 at 3 years, while in the foam group the median AVVQ score improved from 12.28 preoperatively to 4.97 at 3 years. These results were maintained at 5 years.
Scores on the mental component of the SF-36 worsened in the surgery group. There was no change in the physical scores of the SF-36 in either group over 3 or 5 years.
There were no significant differences between the groups or within the groups regarding obliteration or reflux above the knee or below the knee at 3 or 5 years. In the majority of cases, the reflux was asymptomatic and was only detected because of the follow-up duplex examination.
The study was funded by STD Pharmaceutical. Dr. Kalodiki said that she had no relevant financial disclosures to make.