A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence
Autor: | I. Nagtzaam, Y.L. Lam, C.H.A. Wittens, A. A. E. A. De Smet, Fred H. M. Nieman, J.A. Lawson, Anco C. Vahl, Michiel A. Schreve, T. Alozai |
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Přispěvatelé: | Dermatology, MUMC+: MA AIOS Dermatologie (6), MUMC+: MA Dermatologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Dermatologie, MUMC+: MA AIOS Dermatologie (9) |
Jazyk: | angličtina |
Rok vydání: | 2022 |
Předmět: |
medicine.medical_specialty
medicine.medical_treatment Polidocanol THERMAL ABLATION CHRONIC VENOUS DISORDERS CLINICAL-TRIAL Dose finding INSUFFICIENCY Endovenous ablation Occlusion Varicose veins medicine Humans VARICOSE-VEINS Saphenous Vein Single-Blind Method FOAM SCLEROTHERAPY ENDOVENOUS LASER-ABLATION RADIOFREQUENCY ABLATION Vein Mechanochemical ablation business.industry STATEMENT Endovascular Procedures Great saphenous vein ClariVein Ablation Surgery REVISION Treatment Outcome medicine.anatomical_structure Venous Insufficiency medicine.symptom Cardiology and Cardiovascular Medicine business medicine.drug |
Zdroj: | Journal of Vascular Surgery: Venous and Lymphatic Disorders, 10(4), 856-864. Elsevier Inc. Journal of Vascular Surgery. Venous and Lymphatic Disorders, 10(4), 856-864.e2. Elsevier Inc. |
ISSN: | 2213-333X 2213-3348 |
Popis: | BACKGROUND: The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah).METHODS: We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications.RESULTS: From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033).CONCLUSIONS: The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future. |
Databáze: | OpenAIRE |
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