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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

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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
InterventionBest UseLimitation
Surgical (Stripping, ligation, phlebectomy) Tortuous veinsMultiple incisions, time consuming, not ideal for C5-C6
Thermal AblationStraight veins, above kneeTumescence required, not ideal for tortuous veins or below knee
Non-thermal, Non-tumescent catheter-based Straight veins, above kneeNot ideal for tortuous veins or below knee
Compounded FoamTortuous veins, below kneeNot 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

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Displaces blood, effectively filling the lumen for circumferential contact.

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Residual, low-nitrogen bubbles are highly absorbable in blood and are swept away and absorbed in venous circulation.1

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Achieves endothelial destruction with very low polidocanol concentration

The vein contracts, narrowing lumen until vein has almost no volume.

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38-year-old with varicose veins and heavy feeling, throbbing, and swelling

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GSV Reflux 1,830 msec
GSV Diameter 16.1 mm

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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)

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CEAP Distribution

Vein Diameter (mm)

56 Patients (22%) had previous procedure prior to treatment with polidocanol injectable microfoam 1%

Previous ProcedureNumber 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%

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Pre-treatment

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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