Dr. Deak's 2018 publication

Varithena retrospective 250 patient chart review

Objective

Retrospective chart review to evaluate treatment outcomes among symptomatic patients with superficial chronic venous insufficiency using Varithena:

Efficacy – Elimination of symptoms/pathological reflux; vein closure; venous leg ulcer status¹ (e.g. open/closed)
Safety – Incidence of adverse events (e.g. DVT, SVT)

Patients

(n= 250; single center, community practice)

Symptomatic patients with C2–C6 chronic venous insufficiency
Minimum 3 months of prior compression therapy
Ideal patients for Varithena were those with tortuous veins, incompetent veins below the knee or a history of a previous vein ablation procedure
16 of the 250 patients (6.4%) had venous leg ulcers, and 56 (22.4%) were treated previously with thermal ablation or surgery
Mean vein diameter of 8.0 ± 2.5 mm

Methods

Patients underwent a duplex ultrasound (DUS) to map perforators/veins to be treated
The Great Saphenous Vein (GSV) was accessed with a micropuncture needle distal to the mid-thigh perforator followed by a 0.018 guidewire — the guidewire was replaced by a 5F catheter
The leg was placed on a foam wedge at an angle of 45° to empty the varicose veins of blood
5 mL of Varithena (Polidocanol 1%) was injected into the catheter at 0.5 to 1.0 mL/second under ultrasound observation
Once the microfoam arrived within 3 to 5 cm of the saphenofemoral junction, the GSV was compressed for 2 to 3 minutes to limit the flow of microfoam into the common femoral vein
A second injection of 4–5 mL of Varithena was administered through the same catheter directing the microfoam to flow in a retrograde fashion through the incompetent venous valves to the ankle
Following confirmed venospasm, the patient was instructed to dorsiflex the foot for approximately
30 seconds to activate the calf pump and close patent perforators after each injection
The lower extremity was kept elevated on the foam wedge at 45° as dressings were applied to prevent blood from entering the treated vein

Key results

All patients were treated with Varithena, then followed for 16 ± 7 months
Complete elimination of venous valvular reflux and vein closure was documented in 94.4% of patients (vein diameters in this study ranged from 4.1 to 18.7 mm)
94.4% of patients reported symptom relief
Minor adverse events included asymptomatic DVT in two patients (<1%) and superficial venous thrombi in four patients (2%)
Of the 16 patients with venous leg ulcers, 80% of the wounds closed within 4 weeks of treatment¹
Mean Varithena volume administered during the initial procedure was 9.5 ± 2.5 mL
55 patients had an additional follow-up treatment with Varithena between 5 days and ~2 years after initial treatment

Study limitations

Retrospective chart review eliminates methodologic rigor leading to lack of control of intervention timing, data collection, and patient behaviors after the procedure
No comparator dataset
No disease-specific quality of life data
Variable time points for patient follow-up

References

Deak, Steven T. “Retrograde Administration of Ultrasound-Guided Endovenous Microfoam Chemical Ablation for the Treatment of Superficial Venous Insufficiency.” Journal of Vascular Surgery: Venous and Lymphatic Disorders, vol. 6, no. 4, July 2018, pp. 477–484., doi:https://doi.org/10.1016/j.jvsv.2018.03.015. The author is a consultant for Boston Scientific.
1. Healing of venous leg ulcers was not an endpoint in Varithena pivotal trials.