title: Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
authors.forename: Ramon R J P
authors.initials: RR
authors.lastname: van Eekeren
authors.forename: Doeke
authors.initials: D
authors.lastname: Boersma
authors.forename: Steven
authors.initials: S
authors.lastname: Elias
authors.forename: Suzanne
authors.initials: S
authors.lastname: Holewijn
authors.forename: Debbie A B
authors.initials: DA
authors.lastname: Werson
authors.forename: Jean-Paul P M
authors.initials: JP
authors.lastname: de Vries
authors.forename: Michel M J P
authors.initials: MM
authors.lastname: Reijnen
mesh_terms: D055011:Ablation Techniques / Q000009:adverse effects / Q000295:instrumentation*; D000328:Adult; D000368:Aged; D003131:Combined Modality Therapy; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D017060:Patient Satisfaction; D010865:Pilot Projects; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012501:Saphenous Vein / Q000000981:diagnostic imaging; D012597:Sclerosing Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D015911:Sclerotherapy / Q000009:adverse effects / Q000295:instrumentation*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014689:Venous Insufficiency / Q000000981:diagnostic imaging / Q000628:therapy*
chemical_list: D012597:Sclerosing Solutions; D000077423:Polidocanol; D011092:Polyethylene Glycols