Retrograde Microfoam Ablation of Superficial Venous Insufficiency : Review of 250 Cases Steven T Deak, MD, PhD, FACS Deak Vein NJ Clinic Somerset, NJ November 15, 2017

Varicose Veins: Indications for Intervention Leg aching/pain Leg heaviness Leg fatigue Leg swelling Leg itching Bleeding Venous ulcer Atrophic blanche Lipodermatosclerosis General appearance Superficial thrombophlebitis

Background Superficial venous disease affects 30% of the population1,2,3 ~1% of the population has an active (C6) venous leg ulcer (VLU) Treatment of venous leg ulcers cost $14.3 Billion annually Intervention Best Use Limitation Surgical (Stripping, ligation, phlebectomy) Tortuous veins Multiple incisions, time consuming, not ideal for C5-C6 Thermal Ablation Straight veins, above knee Tumescence required, not ideal for tortuous veins or below knee Non-thermal, Non-tumescent catheter-based Not ideal for tortuous veins or below knee Compounded Foam Tortuous veins, below knee Not FDA-approved Surgical and catheter-based approaches pose risk of injury to nerve, skin or muscle.

Polidocanol Injectable Microfoam 1% Varithena® Physician compounded foam FDA approved November 2013 Symptoms: Heaviness, Achiness, Swelling, Throbbing, Itching Indications: Incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Tortuous, straight and large veins >3mm in diameter above and below the knee Reflux in GSV at Sapheno-Femoral Junction greater than 500 msec Diameter of GSV greater than 4.0 mm and up to 25.9 mm POLIDOCANOL low nitrogen content (<0.5%).*%) microfoam that has uniform, density, size, and stability

Polidocanol Injectable Microfoam 1% Achieves endothelial destruction with very low polidocanol concentration Displaces blood, effectively filling the lumen for circumferential contact. Residual, low-nitrogen bubbles are highly absorbable in blood and are swept away and absorbed in venous circulation.1 The vein contracts, narrowing lumen until vein has almost no volume.

GSV Reflux 1,830 msec GSV Diameter 16.1 mm 38-year-old with varicose veins and heavy feeling, throbbing, and swelling Two weeks after treatment with 8 mL polidocanol injectable microfoam 1 % GSV Reflux 1,830 msec GSV Diameter 16.1 mm

Polidocanol Injectable Microfoam 1% Pre-OP Post-Op

Review of 250 Cases Varicose Veins Retrograde administration of polidocanol injectable microfoam 1% March 2015 to June 2017 68% female Age 30 to 95 15% older than 65 Symptoms included heaviness, aching, swelling, throbbing and itching Patients were examined with duplex scan immediately post procedure and again 5 to 7 days after treatment. Elimination of reflux in the GSV was achieved in 94% of patients (236/250)

CEAP Distribution

Vein Diameter (mm)

56 Patients (22%) had previous procedure prior to treatment with polidocanol injectable microfoam 1% Number of Patients Surgical Stripping and Ligation. 17 EVLT Endovenous Laser Ablation 36 Venous Closure with Radiofrequency 3

Adverse Events Two asymptomatic DVTs One Common Femoral Vein Thrombus Extension (CFVTE) Four Superficial Venous Thrombi (SVT) 14 Patients (5.6%) technical failure and needed additional therapy

CEAP 6 Patient treated with polidocanol 1% Pre-treatment Three weeks post-treatment

CEAP 6 Ulcer Patients Treated with Polidocanol Injectable Microfoam 1% 16 patients had CEAP 6 ulcers; 6 with spontaneous bleeding and 10 with non healing ulcers. 80% of the ulcers healed in less than 1 month.

Results of 250 Cases Varicose Veins Elimination of reflux in the GSV in 94 % of patients (236/250) Vein diameter 8 mm +/- 2.5 mm Reflux time in GSV 2,240 msec +/- 1,120 msec Polidocanol volume 9.5 mL +/- 2.5 mL 80% of CEAP 6 Ulcers healed in less 30 days A second treatment was required in 55 patients (22%) for residual reflux in the below knee segment of the GSV

Conculsion Retrograde administration of polidocanol injectable microfoam 1% is an effective treatment for superficial venous insufficiency of GSV and leg ulcers from a single remote access site.

Retrograde Microfoam Chemical Ablation Treatment of Venous Valvular Hypertension and Venous Valvular Reflux in CEAP 6 Ulcers Retrograde Microfoam Chemical Ablation SEPS