First registry of patients treated with foam sclerotherapy using a new automated microfoam preparation device (2021-2022)

Abstract

Objectives: To present results for the use of an automated microfoam preparation system (AMPS) in the treatment of varicose veins in a real-world setting.

Method: We performed a descriptive study based on a prospective database of patients treated with foam sclerotherapy between February 2021 and December 2022. Polidocanol foam was prepared using a capsule containing sterile air or a low-nitrogen mix. We recorded volume per session, percentage of sclerosing drug, number of sessions, release of thrombus entrapment, complications, and adverse events. A univariate descriptive analysis was performed using Stata V.16.

Results: Over a 23-month period, 185 patients (84.9% women, 15.1% men) underwent 685 sessions. Median age was 51.6 years (range, 16-79 years). Thread veins were the condition treated in 68.9% of sessions, tributaries in 7.2%, and truncal veins in 22.6%. The average volume per session was as follows: thread veins, 8 mL; great saphenous vein (GSV), 6.9 mL; and small saphenous vein (SSV), 4.3 mL. The average drug concentration was as follows: thread veins, 0.18%; GSV, 1.49%; and SSV, 1.63%. The average number of sessions was 3.4 for thread veins, 2 for tributaries, 2.7 for the GSV, and 2.9 for the SSV. The occlusion rate at 15 months was 93.2% (41/43) for the great saphenous vein and 86% (13/15) for the small saphenous vein. We recorded a total of 21 complications (3.1% of sessions), 14 of which were minor complications (2% sessions), and 7 moderate adverse events (1% of sessions).

Conclusions: This new device is highly versatile and can be used for preparing foam at all concentrations. It contributes to a high rate of occlusion in saphenous trunks, with a minimal number of sessions required for thread veins indicating that the system is a favorable option in the treatment of venous diseases. Additionally, the low frequency of residual pigmentation may be attributed to the system’s ability to tailor the foam concentration to the individual case, thus supporting optimal outcomes.