REVIEW  VENOUS DISEASE Open access

International Angiology 2025 February;44(1):14-23

DOI: 10.23736/S0392-9590.25.05284-8

Copyright © 2025 THE AUTHORS

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lingua: Inglese

A review of clinical efficacy, safety, and quality of life of ClosureFast™ radiofrequency ablation of saphenous vein insufficiency

Rodrigo RIAL ¹, Megha GARG ² ✉, Nick POOLEY ², Guillermo M. DUCAJU ¹, Alissa DOTH ³, Ines JOAQUIM ⁴

¹ Department of Vascular and Endovascular Surgery, HM Madrid & Torrelodones University Hospitals, Madrid, Spain; ² Maverex Ltd, Newcastle upon Tyne, UK; ³ Medtronic, Inc., Minneapolis, MN, USA; ⁴ Medtronic International Trading Sarl, Tolochenaz, Switzerland

INTRODUCTION: This review aimed to systematically identify the efficacy, safety, and quality of life of ClosureFast^™ radio frequency ablation (RFA) compared with other treatments for saphenous vein insufficiency.
EVIDENCE ACQUISITION: A systematic literature search was conducted using MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, World Health Organization-International Clinical Trials Registry Platform, and ClinicalTrials.gov from the time of their inception to June 2021. Randomised controlled trials (RCTs) comparing ClosureFast^™ to surgery, endovenous laser ablation (EVLA), mechanochemical ablation (MOCA), foam sclerotherapy, or cyanoacrylate closure (CAC) were eligible for inclusion.
EVIDENCE SYNTHESIS: Thirty-two publications, representing 21 RCTs were included. Clinical efficacy (procedure success/failure) for ClosureFast^™ was significantly better compared to Foam, MOCA, and other RFA devices, significantly poorer than CAC; and similar to high ligation and division, stripping, and EVLA. Symptom alleviation was similar between therapies; however, one study reported significantly worse symptom scores for ClosureFast^™ compared to CAC. Compared with ClosureFast^™, patients receiving EVLA treatment exhibited significantly higher pain scores, whereas CAC, MOCA, and other RFA groups reported lower pain scores. ClosureFast^™ showed significantly lower rates of minor complications compared with EVLA in three studies, with rates of complication comparable with other treatments. ClosureFast^™ patients returned to work or normal activity faster than surgical but slower than CAC patients. There was no difference in health-related quality of life and patient satisfaction between treatments.
CONCLUSIONS: ClosureFast^™ has overall higher safety than EVLA and surgery, with better clinical efficacy than Foam, MOCA, and other RFA devices. Efficacy and safety of ClosureFast^™ is comparable to or lower than CAC.

KEY WORDS: Saphenous vein; Venous insufficiency; Cyanoacrylates; Laser therapy; Sclerotherapy; Radiofrequency ablation; Varicose veins