1. 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

2. 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

3. 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.

4. 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

5. 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.

7. 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

8. Polidocanol Injectable Microfoam 1%
Pre-OP
Post-Op

9. 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)

11. CEAP Distribution

12. Vein Diameter (mm)

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

16. 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.

17. 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

18. 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

19. 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

20. 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.

22. 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

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

24. Patient CEAP Distribution