A comparison of patient-reported outcome measures following technical success and technical failure in the treatment of great saphenous vein incompetence using ClariVein: A subanalysis of a multicenter randomized controlled trial comparing 2% and 3% polidocanol

Phlebology. 2023 Sep;38(8):532-539. doi: 10.1177/02683555231189414. Epub 2023 Jul 12.

Abstract

Objective: This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein.

Methods: A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6 months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36).

Results: Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences.

Conclusion: This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.

Keywords: ClariVein; MOCA; Mechanochemical ablation; endovenous ablation; great saphenous vein; patient-reported outcome measures (PROMs); quality of life; varicose veins.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Endovascular Procedures*
  • Humans
  • Patient Reported Outcome Measures
  • Polidocanol
  • Quality of Life
  • Saphenous Vein / diagnostic imaging
  • Treatment Outcome
  • Varicose Veins* / therapy
  • Venous Insufficiency* / therapy

Substances

  • Polidocanol
  • dodecylnonaoxyethylene glycol monoether