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General Session VII

General Session VII - Superficial Venous Disease and Vascular Malformations

Quickshot: Early Experience Managing Intravascular Coagulum Using Polidocanol Endovenous Foam: Risk Factor Analysis

Tuesday, March 5, 2024
5:17 PM – 5:23 PM EST
Location: Tampa Bay Ballroom Salons 1-4
Objective: Polidocanol endovenous microfoam 1% (PEM, Boston Scientific Corporation, Marlborough, MA) has gained widespread acceptance for treating venous insufficiency. Clinical trials of PEM report mild to moderate adverse events in 60% of trial participants, one of the most common being retained intravascular coagulum (IC). This study aims to identify risk factors that lead to increased incidence of IC observed in clinical practice.

Methods: From December 2021 to June 2023, a retrospective cohort study identified all patients that received PEM treatment for venous insufficiency. Baseline demographics, index severity (CEAP and VCSS), and duplex ultrasound studies at their initial visit were compared amongst the IC and non-IC groups. Post-ablation data specific to the IC group (affected extremity and vein, volume of coagulum extracted, timeframe, etc.) was also evaluated.

Results:

A total of 76 patients were treated with PEM. The average age was 61 years and females represented 75% of the cohort. Overall, 16% (12 patients) developed an IC in the early post-ablation period. There was no difference between the subjects that developed IC vs non-IC  for age (P = 0.15),  sex (P = 0.41), or VCSS (P = 0.37) score. Compared to the non-IC group, intravascular coagulum was more frequent in the Latino race (91.7% vs 57.8% P = 0.03). When reflux times were compared, IC was associated with higher reflux times at the great saphenous vein (1887 ms vs 1361 ms, P = 0.040). Presence of at least one below knee perforating vein (25% vs 6.25%, P = 0.04) was more frequent in the IC group. Moreover, there was a trend that the left extremity was more frequently affected (P = 0.09). Lower PEM injection volume (6.26 mL vs 4.18 mL, P = 0.03) was also associated with developing IC. 

Conclusions:

Latino patients were at a higher risk for development of IC. High venous reflux times, presence of a perforator vein, and lower Varithena injection volume were additional risk factors for developing IC. Identification of these perioperative risk factors may alter treatment approach and reduce the incidence of IC.