Dr. Deak's 2021 publication

Comparative treatment of superficial venous insufficiency patients with Varithena vs. endovenous laser ablation

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Objective

To evaluate outcomes among symptomatic patients with superficial venous insufficiency treated with Varithena or endovenous laser ablation (EVLA).

 

Patients

(n = 1070; single center)

  • Symptomatic patients with C2–C6 superficial venous reflux
  • Superficial axial reflux of the great saphenous vein or anterior accessory saphenous vein classified as retrograde flow in the saphenous vein > 0.5 seconds when standing and a vein diameter > 2 mm
  • Failure to have improvement in symptoms after three months of compression therapy (20-30 mmHg stockings)

 

Methods

  • Retrospective chart review between October 2013 and June 2019
  • 550 patients were treated with Varithena and 520 were treated with EVLA
  • Patients were followed up post operatively to collect data on the following:
    • Presence or absence of symptoms
    • Duplex ultrasound assessment
    • Observation of spontaneous bleeding and wound healing in C4 and C6 patients, respectively
  • Treated veins were also evaluated along entire length to document occlusion and/or reflux
  • Veins were determined closed if there is occlusion along entire length of treated segment with no distinct segment of patency that were greater than 5 cm
  • Due to the extensive nature of chronic venous disease in many patients, and limitation that no more than 15 ml of Varithena be administered in one treatment, some patients required a second treatment (at follow-up) to close areas of patent veins

 

Key results

  • The Varithena patients were observed for 43 ± 13 months and the EVLA for 57 ± 18 months
  • Elimination of reflux was 93.5% (514/550) and 92.8% (482/520) of the Varithena and EVLA-treated patients
  • Closure rates were maintained through three-year follow-up
  • 18% of EVLA-treated patients returned for additional treatment to address residual symptoms in the affected leg
  • In C6 patients treated with Varithena, 69% of ulcers were healed in less than one-month compared to 5% of patients treated with EVLA
  • No neurological or cardiac adverse events in the Varithena patients
  • Minor complications included asymptomatic DVT (0.5%), 1 CFVTE, and superficial venous thrombosis (4%) in Varithena-treated patients and asymptomatic DVT (0.8%) and 2 EHITs in EVLA-treated patients
  • This study concluded that Varithena is comparable in safety and efficacy to EVLA for treatment of saphenous reflux

 

Study limitations

  • Retrospective chart review limits outcomes measured to those collected at various time points post-treatment
  • Subjective measure of patient symptoms which were self-reported and binary (present, not present)

References

Deak ST. Treatment of superficial venous insufficiency in a large patient cohort with retrograde administration of ultrasound-guided polidocanolendovenous microfoam versus endovenous laser ablation. J Vasc Surg Venous Lymphat Disord. 2021 Dec 24:S2213-333X(21)00609-0. doi: 10.1016/j.jvsv.2021.11.007. Epub ahead of print. PMID: 34958977.