Focus of the Report: This Health Technology Assessment focuses on the use of mechanochemical endovenous ablation (MOCA), a nonthermal type of ablation for treatment of varicose veins, with the ClariVein infusion catheter (Merit Medical Systems Inc.).
Technology Description: The ClariVein infusion catheter system features a flexible, steerable infusion catheter with a 360-degree–rotatable dispersion wire. The wire tip causes minimal mechanical damage to the endothelium, inducing vasospasm, and the rotating tip evenly distributes a sclerosing agent to the targeted treatment area. After treatment, sealing of the vein is confirmed ultrasonically. Sclerosis of the vein activates the clotting system, resulting in formation of a thrombus and occlusion of the vessel. Patients are treated in an outpatient setting.
Controversy: Traditionally, vein stripping has been used to treat varicose veins. Alternative methods have been sought, as stripping requires general or spinal anesthesia; increases risk for saphenous nerve injury; may result in substantial postoperative pain, hematoma, and recovery time; and has a high recurrence rate (18% to 40% at 5 years). Ablation techniques generally lead to better cosmetic outcomes, less pain, and shorter recovery periods than surgery. Endovascular thermal ablation has largely replaced stripping for treating larger and deeper veins. However, thermal ablation requires tumescence anesthesia and specialized equipment and training, increases risk of damage to normal adjacent tissue, and is associated with relatively common recurrence. The use of nonthermal, nontumescent endovenous techniques, such as MOCA using the ClariVein infusion catheter, is thought to improve patients’ perioperative experiences because there is no risk of thermal injury and no need for tumescent anesthesia. However, controversy surrounds the comparative effectiveness of this system with other endovenous techniques and whether long-term effects are sustained after treatment.
Key Questions:
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Is MOCA with the ClariVein infusion catheter effective for the treatment of varicose veins?
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How does MOCA with the ClariVein infusion catheter compare with alternative therapies for the treatment of varicose veins?
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Is MOCA with the ClariVein infusion catheter in patients with varicose veins safe?
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Have definitive patient selection criteria been identified for MOCA with the ClariVein infusion catheter for the treatment of varicose veins?
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