VNUS® Radiofrequency Ablation (RFA) for Vericose Vein

Executive Summary
[Adapted from the report by SYFUL AZLIE MD FUZI]

Review Group Membership Introduction

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VNUS radiofrequency ablation (RFA) also referred to as the Closure procedure
MaHTAS Reviewer:
Syful Azlie Md Fuzi
is claimed as an incredibly effective, relatively new solution to leg pain and
Dr. Junainah Sabirin varicose veins. Traditionally, those diagnosed with superficial venous reflux
Datin Dr. Rugayah Bakri disease would have to undergo painful varicose vein stripping surgery or laser
treatment. The endovenous RFA procedure is a minimally invasive treatment (day
External Reviewer: surgery), which can be performed under local anaesthesia in a variety of clinical
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settings including hospitals and outpatients. Using the Closure system,
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physicians close the diseased veins by inserting the Closure catheter into a vein
Disclaimer: and heating the vein wall using temperature-controlled radiofrequency energy.
Technology review is a brief Heating the vein wall causes collagen in the wall to shrink and the vein to close.
report, prepared on an urgent After the vein is sealed shut, blood then naturally reroutes to healthy veins.
basis, which draws on restricted
reviews from analysis of pertinent Objective/Aim
literature, on expert opinion and /
or regulatory status where The objective of this technology review was to review evidence on the safety,
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appropriate. It is subjected to an efficacy/effectiveness and cost-effectiveness of using VNUS radiofrequency
external review process. While ablation (RFA) compared with the conventional surgical or other endovenous
effort has been made to do so, this techniques in the treatment of patients with varicose vein.
document may not fully reflect all
scientific research available.
Additionally, other relevant
Results and Conclusions
scientific findings may have been There was retrievable scientific evidence on the safety or adverse events related to
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reported since completion of this the use of VNUS radiofrequency ablation (RFA). However, reported complications
review. of the procedure such as vessel perforation (when the catheter punctures the vein
wall), thrombosis, pulmonary embolism (when a blood clot travels to the lungs),
For further information please phlebitis (inflammation of the vein), infection, nerve damage, arteriovenous fistula
contact:
(an abnormal connection between an artery and a vein), hematoma (bruising), and
Health Technology Assessment skin burn are rare and mostly minor. No other major complications were recorded.
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Section (MaHTAS) The VNUS Closure procedure has been approved by United States Food &
Medical Development Division Drug Administration (US FDA) since 1999 and over 250,000 procedures have
Ministry of Health Malaysia been performed worldwide in an office, ambulatory surgical center or hospital,
Level 4, Block E1, Precinct 1 ® ™
generally under local anaesthesia. The products of VNUS Closure have
Government Office Complex
62590 Putrajaya. obtained CE mark in 1998, and the manufacturer received Quality System
Requirements of the ISO 13485:2003 standard as well.
Tel: 603 8883 1246
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There was good to fair level of retrievable evidence to indicate that the VNUS
Fax: 603 8883 1230 radiofrequency ablation (RFA) was effective in the treatment of patients with
varicose vein. In a comparative trial versus vein stripping surgery or other
Available at the following website:
http://www.moh.gov.my endovenous techniques, results were in favour of the RFA treatment. Findings
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indicated that patients who underwent the Closure procedure were associated
with a faster recovery and less postoperative pain. Patients resumed normal
activities within one day or two, and returned to work more than a week earlier.
Patient satisfaction, quality of life improvement, and analgesic requirements
significantly favoured RFA treatment.
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There was also evidence to suggest that VNUS radiofrequency ablation (RFA),
performed under local/tumescent anaesthesia in an outpatient or office-based
setting, was likely to be a cost-effective and reasonable strategy for the treatment
of primary great saphenous vein (GSV) reflux. The generated incremental cost-
effectiveness ratio (ICER) was £17,350 per quality-adjusted life year (QALY),
offering the greatest gain in life-expectancy. In United Kingdom (UK), the ICER
was less than £20,000 per QALY. A comparison of treatment costs (from
procedure to recovery) between RFA and conventional surgery in a selected
2012 population within a prospective randomised controlled trial revealed that RFA was
more expensive (mean hospital cost per patient £1,276 versus £559) but RFA
enabled patients to return to work one week earlier than those undergone surgery.

Executive Summary
The increased cost of RFA is partly offset by a quicker return to work in the
employed group.
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According to the manufacturer, VNUS ClosureRFG radiofrequency generator
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cost approximately RM 80,000 per unit plus RM 2,000 each for VNUS
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ClosureFAST catheter. Besides, an additional cost about RM 60 for accessories
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(disposable) containing all the ancillary items required in performing the Closure
procedure.
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Based on the above review, VNUS radiofrequency ablation (RFA) also called the
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Closure procedure can be used as alternative for conventional surgical or other
endovenous techniques in the treatment of patients with varicose vein. Perceived
advantages over traditional open surgical therapy include fewer complications,
decreased pain, morbidity, better cosmetic result, and enhanced recovery. It
appears economically advantageous for society, especially among employed
patients.

Methods
Literatures were searched through electronic databases specifically PubMed,
Medline, Cochrane, Ovid, Horizon scanning databases, other websites; US FDA,
MHRA and from non scientific database - Google search engine. In addition, a
cross-referencing of the articles retrieved was also carried out accordingly to the
topic. Relevant articles were critically appraised and evidence graded using
US/Canadian Preventive Services Task Force.

Executive Summary