Outcomes of ultrasound-guided catheter-directed foam sclerotherapy with or without perivenous tumescent enhancement in the treatment of great saphenous vein reflux

Abstract

© JOURNAL OF THE MEDICAL ASSOCIATION OF THAILAND| 2019. Background: Great saphenous reflux is widely managed by endovenous methods as first line treatment. Sclerotherapy is a recommendation when other endovenous treatments are not. Ultrasound-guided catheter-directed foam sclerotherapy appears to be attractive and suitable. Tumescent anesthesia is used in other endovenous thermal treatments to help with vein compression around the catheter for better contact and prevent heat damage. In developing countries like Thailand, the costs of the standardized instruments such as radiofrequency ablation or endovenous laser are costly. Not many patients can afford such treatments alternative of a minimally invasive treatment in truncal vein reflux. But it is inferior in terms of closure rate. Objective: In general, foam sclerotherapy has an closure rate of only about 70% in 3 years. The compressive effect of tumescent anesthesia can be applied to help increase the effectiveness of sclerotherapy as it can compress the vein and empty the blood. Therefore, better contact of the sclerosant to the vein wall and the concentration of the sclerosant is not dissipated by the blood. Perivenous tumescent injection together with ultrasound-guided catheter-directed foam sclerotherapy was proposed. Reviewed literature showed lower costs and acceptable satisfaction. Materials and Methods: Randomization of 31 patients with 38 treated legs in total. 16 patients with 20 treated legs were enrolled in the tumescent group and 15 patients with 18 treated legs in the non-tumescent group. 1% aethoxysklerol was used as sclerosant. Tumescent solution was comprised of 1% xylocaine, ketorolac, 0.9% NSS, and dexamethasone. Patients were treated as ambulatory cases with light sedation in the operating room. Patients were followed-up at 2-week, 1-month, 3-month and 6-month intervals with duplex ultrasonography performed by vascular fellows. Primary outcome was closure rates between the two groups. Secondary outcomes were VCSS, incidence of DVT or symptomatic PE, any other adverse events and satisfaction score. Results: Both groups were not statistically significant in terms of occlusion rate by the Kaplan-Meier curve (p = 0.891). Occlusion rates at 90 days were 93.75% in the tumescent group and 100% in the non-tumescent group, at 150 days were 81.2% in the tumescent group and 78.1% in the non-tumescent group. DVT or PE 0%. Adverse events were ecchymosis in two patients and cord like tenderness in one. Mean satisfaction score at last follow-up was 4 out of 5. Reduction in the VCSS at the end of follow-up period compared to pre-operatively was not statistically different between the two groups. Conclusion: Perivenous tumescent enhanced ultrasound-guided foam sclerotherapy solution did not demonstrate improvement in occlusion rate. But it could be performed as an outpatient setting with no major adverse events.