Retrograde Microfoam Ablation of Superficial Venous Insufficiency: Review of 250 Cases Steven T Deak, MD, PhD, FACS Hungarian Medical Association of America Sarasota, Florida October 31, 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% to 40% of the population1,2 ~1% of the population has an active (C6) venous leg ulcer (VLU) 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)

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.

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

Results of 250 Cases Varicose Veins Duplex Ultrasound Assesment Complete initial elimination of reflux in the GSV in 94 % of patients (236/250) Mean Vein diameter 8 +/-2.5 mm Mean Reflux time in GSV 2,240 +/- 1,120 msec Mean polidocanol volume 9.5 +/- 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

Adverse Events Two asymptomatic DVTs One Common Femoral Vein Thrombus Extension (CFVTE) Four Superficial Venous Thrombi (SVT) 14 Patients needed additional treatment due to persistent areas of patency after initial treatment with 15 mL Polidocanol Injectable Microfoam 1 % Of note: Labeled indication is no more than 15 mL of 1% PEM per treatment session

Conclusions Retrograde chemical ablation of GSV insufficiency with 1% polidocanol from a single injection site allows for the treatment of the GSV and its below knee tributaries that are not readily amenable to surgical or thermal ablation. Technique results in a shorter ulcer healing time as compared to thermal ablation of the GSV with or without adjunct surgical procedures. Elevating the leg before administering the polidocanol 1% results in better closure rates than seen with other ablation techniques Retrograde chemical microfoam ablation is a useful adjunct in treating patients who have recurrent venous reflux after failed surgical or thermal ablation.

Foundational Principle Find and treat the underlying source of the venous hypertension feeding the incompetent vein or ulcer. Choose a therapy that: Can access areas that wire-based devices cannot Mitigates risks in treating patients with advanced C5-C6 disease Improves patients symptoms

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

Patient CEAP Distribution