TY - JOUR
T1 - Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device
T2 - A safety study
AU - Van Eekeren, Ramon R.J.P.
AU - Boersma, Doeke
AU - Elias, Steven
AU - Holewijn, Suzanne
AU - Werson, Debbie A.B.
AU - De Vries, Jean Paul P.M.
AU - Reijnen, Michel M.J.P.
PY - 2011/6/1
Y1 - 2011/6/1
N2 - Purpose: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. Methods: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. In a pilot study, 30 limbs in 25 patients (18 women; mean age 52 years) with GSV incompetence were treated with MOCA using polidocanol at 2 centers. Initial technical success, complications, patient satisfaction, and classification by venous clinical severity score (VCSS) were assessed 6 weeks after the treatment. Results: Initial technical success of MOCA was 100%. There were no major adverse events. Minor complications consisted of 9 local ecchymoses at the puncture site and superficial phlebitis that resolved within a week in 4 limbs. Duplex ultrasonography at 6 weeks showed 26 (87%) of 30 veins were completely occluded; 3 veins showed partial recanalization in the proximal (n=2) and distal GSV. One patient had full segment recanalization and was successfully retreated. The VCSS significantly improved at 6 weeks (p<0.001). Patient satisfaction was high, with a median satisfaction of 8.8 on a 0-10 scale. Conclusion: This study showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of GSV incompetence. Larger studies with a prolonged follow-up are indicated to prove the efficacy of this technique in terms of obliteration rates.
AB - Purpose: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. Methods: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. In a pilot study, 30 limbs in 25 patients (18 women; mean age 52 years) with GSV incompetence were treated with MOCA using polidocanol at 2 centers. Initial technical success, complications, patient satisfaction, and classification by venous clinical severity score (VCSS) were assessed 6 weeks after the treatment. Results: Initial technical success of MOCA was 100%. There were no major adverse events. Minor complications consisted of 9 local ecchymoses at the puncture site and superficial phlebitis that resolved within a week in 4 limbs. Duplex ultrasonography at 6 weeks showed 26 (87%) of 30 veins were completely occluded; 3 veins showed partial recanalization in the proximal (n=2) and distal GSV. One patient had full segment recanalization and was successfully retreated. The VCSS significantly improved at 6 weeks (p<0.001). Patient satisfaction was high, with a median satisfaction of 8.8 on a 0-10 scale. Conclusion: This study showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of GSV incompetence. Larger studies with a prolonged follow-up are indicated to prove the efficacy of this technique in terms of obliteration rates.
KW - Endovenous ablation
KW - Endovenous therapy
KW - Great saphenous vein
KW - Mechanical endothelial damage
KW - Polidocanol
KW - Sclerosant
KW - Varicose veins
KW - Venous incompetence
UR - http://www.scopus.com/inward/record.url?scp=79959298602&partnerID=8YFLogxK
U2 - 10.1583/11-3394.1
DO - 10.1583/11-3394.1
M3 - Article
C2 - 21679070
AN - SCOPUS:79959298602
SN - 1526-6028
VL - 18
SP - 328
EP - 334
JO - Journal of Endovascular Therapy
JF - Journal of Endovascular Therapy
IS - 3
ER -