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After eight years of impaired quality of life due to venous incompetence, Varithena treatment leads to improved symptoms and appearance

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Case Study Contributor

Keith E. Campbell, MD, RVT
Tennessee Vein Center, Alcoa, TN

Board Certified: American Board of Venous and Lymphatic Medicine

“When I met this patient, I knew treatment could be life-changing. He was young and had spent 25% of his life dealing with the pain, symptoms, and complications of severe venous disease. Six months later I am thrilled that he is active and living the life that he should at the age of 39.”

Patient Characteristics

A 39-year-old male presented to the clinic with bilateral lower extremity C6 venous disease. The patient had recurrent venous leg ulcerations (VLUs) and recently had two episodes of severe bleeding from a right lower extremity varicosity at the site of ulceration, one requiring a visit to the emergency room.

While the ulcers have been present for five weeks, the patient has an 8-year history of progressive venous disease in both his legs.

The patient has used analgesics and compression hose to help with his chronic symptoms of leg pain, aching, itching, burning and ankle/leg swelling.

Patient Work-up: CEAP Class 6

  • Vein diameters in the left leg ranged from 3.5mm in the SSV, to 11.6mm in the GSV, to 14.5 at the CFV. In the right leg, diameters were 4.9mm, 14.2mm, and 17.2mm, in the SSV, GSV, and CFV, respectively.
  • The patient did not have a history of prior vein treatment.

 



Treatment and Results

Due to the extensive bilateral disease above and below the knee, laser ablation and Varithena were used. Varithena was used in all tortuous segments of the GSV. The patient required two treatments of Varithena for each leg.

For each treatment, access was gained using a 21-gauge butterfly needle. A direct access approach was chosen because the patient had many tortuous segments.

The leg was raised to decrease GSV diameter, reducing the amount of Varithena needed to treat his large veins.

In the left leg, six injections were used in the below-knee GSV to deliver 12cc and 6cc of Varithena on separate occasions. In the right leg, five injections were used to deliver 14cc and 7cc to above-and below-knee GSV segments on separate occasions.

Post-treatment, the GSVs were non-compressible, reflux had minimized, and the patient commented that his symptoms were improved. No complications were documented.

Six months post-treatment, the appearance of his legs had greatly improved and the patient commented that he was finally able to be active again.

 



Conclusion

Varithena proved to be an effective treatment modality when used with laser. With laser alone, it was not possible to treat him comprehensively due to his complex anatomy and skin changes.

 

Documentation

legs with ulcers pre-treatement

Figure 1. Patient Pre-treatment.

 

 

ulcers on legs post treatment

Figure 2. Varithena was used in all tortuous segments of the GSV above and below the knee. The patient required two treatments of Varithena for each leg. Laser ablation was also used in straight segments of the proximal GSV.

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* Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

Indications

Varithena® (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins,  accessory saphenous veins and visible varicosities of the great saphenous vein (GSV) system above and below the knee. Varithena® improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

Important Safety Information

The use of Varithena® is contraindicated in patients with known allergy to polidocanol and those with acute thromboembolic disease. Severe allergic reactions have been reported following administration of liquid polidocanol, including anaphylactic reactions, some of them fatal. Observe patients for at least 10 minutes following injection and be prepared to treat anaphylaxis appropriately. Intra-arterial injection or extravasation of polidocanol can cause severe necrosis, ischemia or gangrene. Patients with underlying arterial disease may be at increased risk for tissue ischemia. If intra-arterial injection of polidocanol occurs, consult a vascular surgeon immediately.Varithena® can cause venous thrombosis. Follow administration instructions closely and monitor for signs of venous thrombosis after treatment. Patients with reduced mobility, history of deep vein thrombosis or pulmonary embolism, or recent (within 3 months) major surgery, prolonged hospitalization, or pregnancy are at increased risk for developing thrombosis. The most common adverse events observed were pain/discomfort in extremity, retained coagulum, injection site hematoma or pain, common femoral vein thrombus extension, superficial thrombophlebitis, and deep vein thrombosis.Physicians administering Varithena® must be experienced with venous procedures, possess a detailed working knowledge of the use of the duplex ultrasound in venous disease and be trained in the administration of Varithena®.

See Full Prescribing Information for Varithena®

Varithena™ is a registered trademark of Boston Scientific. All other trademarks are property of their respective owners.
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