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A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence

Published:November 11, 2021DOI:https://doi.org/10.1016/j.jvsv.2021.10.016

      Abstract

      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.

      Keywords

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      References

        • Mueller R.L.
        • Raines J.K.
        ClariVein mechanochemical ablation: background and procedural details.
        Vasc Endovascular Surg. 2013; 47: 195-206
        • Witte M.E.
        • Holewijn S.
        • van Eekeren R.R.
        • de Vries J.P.
        • Zeebregts C.J.
        • Reijnen M.M.
        Midterm outcome of mechanochemical endovenous ablation for the treatment of great saphenous vein insufficiency.
        J Endovasc Ther. 2017; 24: 149-155
        • Hamel-Desnos C.
        • Allaert F.A.
        Liquid versus foam sclerotherapy.
        Phlebology. 2009; 24: 240-246
        • Lam Y.L.
        • Toonder I.M.
        • Wittens C.H.
        Clarivein(R) mechano-chemical ablation an interim analysis of a randomized controlled trial dose-finding study.
        Phlebology. 2016; 31: 170-176
        • Eklöf B.
        • Rutherford R.B.
        • Bergan J.J.
        • Carpentier P.H.
        • Gloviczki P.
        • Kistner R.L.
        • et al.
        Revision of the CEAP classification for chronic venous disorders: consensus statement.
        J Vasc Surg. 2004; 40: 1248-1252
        • Vasquez M.A.
        • Rabe E.
        • McLafferty R.B.
        • Shortell C.K.
        • Marston W.A.
        • Gillespie D.
        • et al.
        Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group.
        J Vasc Surg. 2010; 52: 1387-1396
        • Klem T.M.
        • Sybrandy J.E.
        • Wittens C.H.
        • Essink Bot M.L.
        Reliability and validity of the Dutch translated Aberdeen varicose vein questionnaire.
        Eur J Vasc Endovasc Surg. 2009; 37: 232-238
        • Garratt A.M.
        • Ruta D.A.
        • Abdalla M.I.
        • Russell I.T.
        Responsiveness of the SF-36 and a condition-specific measure of health for patients with varicose veins.
        Qual Life Res. 1996; 5: 223-234
        • Hawker G.A.
        • Mian S.
        • Kendzerska T.
        • French M.
        Measures of adult pain: visual analog scale for pain (VAS pain), numeric rating scale for pain (NRS pain), McGill pain questionnaire (MPQ), short-form McGill pain questionnaire (SF-MPQ), chronic pain grade scale (CPGS), short form-36 bodily pain scale (SF-36 BPS), and measure of intermittent and constant osteoarthritis pain (ICOAP).
        Arthritis Care Res (Hoboken). 2011; 63: S240-S252
        • Omary R.A.
        • Bettmann M.A.
        • Cardella J.F.
        • Bakal C.W.
        • Schwartzberg M.S.
        • Sacks D.
        • et al.
        • Society of Interventional Radiology Standards of Practice Committee
        Quality improvement guidelines for the reporting and archiving of interventional radiology procedures.
        J Vasc Interv Radiol. 2003; 14: S293-S295
        • Duffett L.
        • Kearon C.
        • Rodger M.
        • Carrier M.
        Treatment of superficial vein thrombosis: a systematic review and meta-analysis.
        Thromb Haemost. 2019; 119: 479-489
        • Norris M.J.
        • Carlin M.C.
        • Ratz J.L.
        Treatment of essential telangiectasia: effects of increasing concentrations of polidocanol.
        J Am Acad Dermatol. 1989; 20: 643-649
        • Metz K.A.
        • Erhard J.
        • Gross E.
        • Donhuijsen K.
        Zur Wirkung unterschiedlicher Sklerosierungsmittel auf den Rattenösophagus.
        Z Gastroenterol. 1986; 24: 605-611
        • van Eekeren R.R.
        • Boersma D.
        • Holewijn S.
        • Vahl A.
        • de Vries J.P.
        • Zeebregts C.J.
        • et al.
        Mechanochemical endovenous ablation versus radiofrequency ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.
        Trials. 2014; 15: 121
        • Vos C.G.
        • Ünlü Ç.
        • Bosma J.
        • van Vlijmen C.J.
        • de Nie A.J.
        • Schreve M.A.
        A systematic review and meta-analysis of two novel techniques of nonthermal endovenous ablation of the great saphenous vein.
        J Vasc Surg Venous Lymphat Disord. 2017; 5: 880-896
        • Kundu S.
        • Lurie F.
        • Millward S.F.
        • Padberg Jr., F.
        • Vedantham S.
        • Elias S.
        • et al.
        Recommended reporting standards for endovenous ablation for the treatment of venous insufficiency: joint statement of the American Venous Forum and the Society of Interventional Radiology.
        J Vasc Surg. 2007; 46: 582-589
        • Rasmussen L.H.
        • Lawaetz M.
        • Bjoern L.
        • Vennits B.
        • Blemings A.
        • Eklof B.
        Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins.
        Br J Surg. 2011; 98: 1079-1087
        • Eklof B.
        • Perrin M.
        • Delis K.T.
        • Rutherford R.B.
        • Gloviczki P.
        • American Venous Forum
        • et al.
        Updated terminology of chronic venous disorders: the VEIN-TERM transatlantic interdisciplinary consensus document.
        J Vasc Surg. 2009; 49: 498-501
        • Xu Y.
        Effects of high hemodynamics upon the morphology of the walls of the great saphenous vein and splenic vein.
        Int Angiol. 2014; 33: 292-298
        • Van der Velden S.K.
        • Lawaetz M.
        • De Maeseneer M.G.
        • Hollestein L.
        • Nijsten T.
        • van den Bos R.R.
        • et al.
        Predictors of recanalization of the great saphenous vein in randomized controlled trials 1 year after endovenous thermal ablation.
        Eur J Vasc Endovasc Surg. 2016; 52: 234-241
        • Theivacumar N.S.
        • Dellagrammaticas D.
        • Beale R.J.
        • Mavor A.I.
        • Gough M.J.
        Factors influencing the effectiveness of endovenous laser ablation (EVLA) in the treatment of great saphenous vein reflux.
        Eur J Vasc Endovasc Surg. 2008; 35: 119-123
        • Vähäaho S.
        • Mahmoud O.
        • Halmesmäki K.
        • Albäck A.
        • Noronen K.
        • Vikatmaa P.
        • et al.
        Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins.
        Br J Surg. 2019; 106: 548-554
        • Khor S.N.
        • Lei J.
        • Kam J.W.
        • Kum S.
        • Tan Y.K.
        • Tang T.Y.
        ClariVein™—one year results of mechano-chemical ablation for varicose veins in a multi-ethnic Asian population from Singapore.
        Phlebology. 2018; 33: 687-694
        • Bishawi M.
        • Bernstein R.
        • Boter M.
        • Draughn D.
        • Gould C.F.
        • Hamilton C.
        • et al.
        Mechanochemical ablation in patients with chronic venous disease: a prospective multicenter report.
        Phlebology. 2014; 29: 397-400
        • Mohamed A.H.
        • Leung C.
        • Wallace T.
        • Pymer S.
        • Harwood A.
        • Smith G.
        • et al.
        Mechanochemical ablation for the treatment of superficial venous incompetence: a cohort study of a single centre's early experience.
        Phlebology. 2019; 34: 466-473
        • Vähäaho S.
        • Halmesmäki K.
        • Mahmoud O.
        • Albäck A.
        • Noronen K.
        • Venermo M.
        Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins.
        J Vasc Surg Venous Lymphat Disord. 2021; 9: 652-659
        • Boersma D.
        • van Eekeren R.R.
        • Werson D.A.
        • van der Waal R.I.
        • Reijnen M.M.
        • de Vries J.P.
        Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series.
        Eur J Vasc Endovasc Surg. 2013; 45: 299-303
        • Tang T.Y.
        • Kam J.W.
        • Gaunt M.E.
        ClariVein®—early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins.
        Phlebology. 2017; 32: 6-12
        • Sun J.J.
        • Chowdhury M.M.
        • Sadat U.
        • Hayes P.D.
        • Tang T.Y.
        Mechanochemical ablation for treatment of truncal venous insufficiency: a review of the current literature.
        J Vasc Interv Radiol. 2017; 28: 1422-1431
        • Bootun R.
        • Lane T.R.
        • Dharmarajah B.
        • Lim C.S.
        • Najem M.
        • Renton S.
        • et al.
        Intra-procedural pain score in a randomised controlled trial comparing mechanochemical ablation to radiofrequency ablation: the Multicentre Venefit™ versus ClariVein® for varicose veins trial.
        Phlebology. 2016; 31: 61-65
        • Witte M.E.
        • Zeebregts C.J.
        • de Borst G.J.
        • Reijnen M.M.P.J.
        • Boersma D.
        Mechanochemical endovenous ablation of saphenous veins using the ClariVein: a systematic review.
        Phlebology. 2017; 32: 649-657
        • Gillet J.L.
        • Guedes J.M.
        • Guex J.J.
        • Hamel-Desnos C.
        • Schadeck M.
        • Lauseker M.
        • et al.
        Side-effects and complications of foam sclerotherapy of the great and small saphenous veins: a controlled multicentre prospective study including 1,025 patients.
        Phlebology. 2009; 24: 131-138
        • Bergan J.
        • Pascarella L.
        • Mekenas L.
        Venous disorders: treatment with sclerosant foam.
        J Cardiovasc Surg (Torino). 2006; 47: 9-18
        • Duffy D.M.
        Sclerosants: a comparative review.
        Dermatol Surg. 2010; 36: 1010-1025