Abstract
Keywords
Non-thermal therapies, supported by clinical studies, real-world data, and expert consensus, have transformed the treatment of truncal venous reflux and branch varicose veins. Non-Compounded Foam (polidocanol endovenous microfoam, PEM, Varithena®) was FDA-approved in 2013 for chronic venous insufficiency and varicose veins, and exemplifies this progress. A recent meta-analysis along with other in vitro and clinical data confirms Varithena’s safety and efficacy, as was detailed in the comprehensive literature review and position paper by the American Vein and Lymphatic Society (AVLS).1,2 This review highlights Varithena’s role in both typical and complex cases where non thermal ablations may be an effective and possibly superior alternative in some scenarios. Several Varithena treatment considerations from their review are summarized below.
Pharmacologic considerations
Varithena’s unique formulation outperforms liquid sclerotherapy and physician-compounded foam (PCF) both in clinical studies and in vitro evaluations. Liquid sclerotherapy lacks sufficient vessel wall contact for effective closure in larger veins. PCF, made with room air or CO2, poses risks: room air introduces non-absorbable nitrogen, linked to possible strokes, transient ischemic attacks, and headaches, while CO2 reduces bubble persistence. In contrast, Varithena’s consistently small, uniform bubbles, minimal nitrogen, and optimal viscosity promotes antegrade flow and minimizes these risks.
Physiologic considerations
The vertical fluid column in the leg’s venous system, when refluxing, adversely impacts tributaries, and perforators, causing varicosities, and symptoms like swelling, hyperpigmentation, and ulcers. Catheter-based thermal closures above the knee often leave pressurized below-knee vessels untreated, contributing to persistent symptoms or earlier recurrence. Varithena effectively treats the below-knee great saphenous vein and the associated refluxing tributaries, minimizing these harmful pressure gradients with less risk of saphenous nerve injury.
Anatomic considerations
Anatomic variations, such as tortuous veins, post-thrombotic intraluminal venous scarring, or small vessel lumens, may significantly hinder the ability to perform catheter-based thermal treatments. Varithena’s foam is ideal for these challenges, as well as for ablating the venous plexuses around ulcers, something increasingly recognized as essential to enhance wound healing and preventing recurrent ulcers. However, one regulatory gap is that Varithena still lacks FDA clearance for ablating non saphenous tributaries, as well as the small saphenous vein, a common site for post thrombotic scarring or small lumens. This necessitates off-label use and underscores the need for advocacy to achieve expanded indications.
Regulatory and coding considerations
Varithena is cleared by the FDA for ablation of the great saphenous vein, anterior saphenous vein and visible varicosities, unlike PCF. Some insurers mandate off-label PCF use for small saphenous vein ablation, despite Varithena’s superior safety and efficacy, and despite FDA approved polidocanol IFU guidance against the use of PCF in the United States (3). Current CPT code descriptions for Varithena do not include the small saphenous vein and branch varicosities, despite the fact that they can be the best choice for complex cases like recurrent saphenopopliteal junction reflux derived varicosities, venous ulcers and patients with bleeding varicose veins. Advocacy to include address these CPT code gaps is critical.
Summary and future directions
The AVLS position paper summarizing the vast body of published real world data provides compelling evidence for Varithena’s necessity and make a compelling case for its expanded use. Continuing multi-society advocacy is needed to address inconsistent payer policies, such as arbitrary treatment and anatomic limits, ensuring evidence-based access to Varithena. This will enhance patient outcomes by reducing recurrence and improving quality outcomes. 3
Footnotes
Author Contributions
Conceived of idea (EB, JA, JF), Contributed to the design and implementation, and to the writing of the manuscript (EB, JA, JF).
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Guarantor
Edward Boyle.
