Author: Deak Vein NJ Clinic
Retrograde Chemical Ablation for Venous Ulcers – American College Phlebology 7-23-2016
Retrograde Chemical Ablation Varicose Veins – Eastern Vascular Society 9-15-2016
American College Phlebology Varithena Ulcer 7-20-2017
Varithena
Retrograde Chemical Ablation for Venous Insufficiency – American Venous Forum 2-23-2018
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Retrograde Microfoam Ablation of Superficial Venous Insufficiency
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 | Straight veins, above knee | 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%
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
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
Achieves endothelial destruction with very low polidocanol concentration
The vein contracts, narrowing lumen until vein has almost no volume.
38-year-old with varicose veins and heavy feeling, throbbing, and swelling
GSV Reflux 1,830 msec
GSV Diameter 16.1 mm
Two weeks after treatment with 8 mL 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%
| Previous Procedure | 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
Conclusion
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.
Treatment of Venous Valvular Hypertension and Venous Valvular Reflux in CEAP 6 Ulcers
Retrograde Microfoam Chemical Ablation
SEPS