Radiofrequency Ablation vs. EVLT®

Endovenous radio frequency (RF) ablation (also called the Closure® procedure) is a varicose vein treatment alternative which involves insertion of a catheter with electrodes into the target vein and passage of RF energy (electricity) through the vein tissue. In recent years, it has been surpassed by endovenous laser as the predominant minimally-invasive varicose vein ablation procedure due to the improved outcomes and decreased complications of EVLT®. A summary comparison of EVLT® vs. RF ablation is shown below:

EVLT® vs. RF

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	EVLT®	Radiofrequency (RF)
Primary Mechanism	Laser	Electricity
Success Rate (comparative studies)	94-100%^1,2,8,4	86-92%^1,2,8,11
Complications
Deep Vein Thrombosis (DVT) or Saphenous Thrombus Extension	0.3%^4,5	2.1%^4,6
Pulmonary Embolism (PE)	None Reported⁷	17 cases⁷
Side Effects
Bruising	Mild to Moderate (<35%)^3,8,10	Mild to Moderate (<35%)^8,9,10
Bruising w/swelling	Mild to Moderate (<25%)^8,10	Mild to Moderate (<25%)^8,9,10
Numbness	0.08%^3,8,10	11%^9,11,12,13
Post-Op Experience	Compression stockings prescribed Walking immediately encouraged Will feel a delayed tightness (or “pulling” sensation) 4-7 days after laser treatment which is normal and expected following a successful treatment	Compression stockings prescribed Walking immediately encouraged
# Procedures (2006)¹⁴	103,000	78,000
Patient Satisfaction (would recommend to a friend)	99.8%³	98%¹⁵
Black CM, et al Failure Rates of Endovenous Radiofrequency Ablation Compared Endovenous Laser Ablation J Vasc Interv Radiol 2005;16(2 Suppl 2):S52 Isaacs M, Gardner M, Comparison of Duplex Guided Sclerotherapy, Closure and EVLT in a Single Practice. 17th Annual Congress, American College of Phlebology. Aug 2003 Min, Khilnani, Zimmet. Endovenous Laser Treatment of Saphenous Vein Reflux: Long-Term Results. J Vasc Interv Radiol; 2003;14:991-996 Mozes G, Gloviczki P, et al Extension of saphenous thrombus into the femoral vein: A potential complication of new endovenous ablation tech niques J Vasc Surg 2005;41:130-5 No DVT reported (MAUDE, see footnote 7); 0.3% represents non-occlusive thrombus extension Some DVT reported (MAUDE); 2.1% represents combination of DVT and non-occlusive thrombus extension FDA reported events on Manufacturer & User Facility Device Experience (MAUDE) database (up to September 2007) since product inception. Up to date results available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P Endovenous Laser Therapy and Radiofrequency Ablation of the Great Saphenous Vein: Analysis of Early Efficacy and Complications J Vasc Surg 2005;42:488-93 Lurie, F, et al. Prospective randomized study of endovenous radiofrequency obliteration (Closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study), J Vasc Surg 2003; 38(2):207-14. Zimmet SE. Pain, Bruising and Short-Term Efficacy after Endovenous Treatment of the Greater Saphenous Vein: The Effect of Operative Technique and Postoperative Care. 16th Annual Congress American College of Phlebology. Nov 2002 Almeida JI, Raines J Radiofrequency Ablation and Laser Ablation in the Treatment of Varicose Veins. Ann Vasc Surg 2006; 20:547-552 Rautio et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: A randomized con trolled trial with comparison of the costs. J Vasc Surg 2002;35:958-65 Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg. 2002 Jun;35(6):1190-6 Millenium Research Group, US Markets for Varicose Vein Treatment Devices 2006. GSV procedures only. Laser volume reflects all lasers. Weiss RA, et al. Controlled Radiofrequency Endovenous Occlusion Using a Unique Radiofrequency Catheter Under Duplex Guidance to Eliminate Saphenous Varicose Vein Reflux: A 2-Year Follow-up, Dermatologic Surgery, Jan 2002; 28:1: 38-42 PP1393B Issue 2 10/07 Copyright Diomed Inc. One Dundee Park Suite 5/6 Andover, MA All rights reserved

“Clinical literature clearly shows EVLT to be more effective and less traumatic than ligation & stripping. I expect this procedure to replace the vast majority of L&S procedures for varicose vein treatment over the next few years. It’s simple, easy to learn, and patients love the results. You owe it to your patients to offer this option.”

- David Vanderpool, MD, Vascular Surgeon. Laser and Vein Aesthetics, Brentwood, TN

“We have performed hundreds of endovenous ablative procedures in our vein practice using both radiofrequency (RF) and laser (EVLT®). Our experience has shown EVLT to be a significantly more effective method for vein ablation compared to RF… we have seen an approximate ten-fold greater recanalization rate with RF as opposed to EVLT. Simply put, EVLT is more effective, faster and less expensive to perform. Any patient who would have to undergo a repeat procedure will wholeheartedly agree.”

Carl M. Black, MD. Director, Vascular and Interventional Radiology, The Intermountain Vein Center and Utah Valley Interventional Associates, Provo, UT

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