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aphenous Ablation: Whatre the Choices, Laser or RF Energyick Morrison, MD, FACS

Endovenous ablation has been reported to be safe and effective in eliminating the proximalportion of the great saphenous vein from the venous circulation, with faster recovery andbetter cosmetic results than surgical stripping. However, the definition of a successfuloutcome in the literature has not been uniform. As in a successful stripping procedure,complete elimination of at least the proximal portion of the great saphenous vein shouldalso be the standard for these endovenous ablation procedures. Our experience with over1,400 endovenous ablation procedures, of which 1,150 were radiofrequency and over 250were laser procedures, has allowed evaluation and comparison of these two techniques.And while we have not seen as high success rates as in published reports (especially withlaser ablation), we have still concluded that both radiofrequency and laser techniques todestroy the saphenous vein are safe and effective. Patient acceptance is overwhelminglybetter than stripping. Physicians performing these techniques should embrace a commit-ment to addressing all sites of venous insufficiency in a patient, not just the proximal greatsaphenous vein. Without this level of commitment, one will be left with poor results and adissatisfied patient.Semin Vasc Surg 18:15-18 © 2005 Elsevier Inc. All rights reserved.

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OWER EXTREMITY VENOUS insufficiency involving thegreat saphenous vein (GSV) has been treated historically

ith groin-to-ankle stripping.1 More recently, invaginationtripping (PIN) of the GSV from groin to knee has been favor-bly compared to traditional stripping, with comparable results,ess tissue damage, faster and less painful recovery, and betterosmetic results.2 Endovenous ablation has been reported to beafe and effective in eliminating the proximal portion of the GSVrom the venous circulation, with even faster recovery and betterosmetic results than stripping.3-6

The two currently available methods used to achieve abla-ion of the GSV are the Closure® procedure using a radiofre-uency (RF) catheter and generator (VNUS Medical Technol-gies, Inc, Sunnyvale, CA, USA) and the endovenous laserblation procedure using a laser fiber and generator (variousanufacturers). Both systems use electromagnetic energy toestroy the GSV in situ.

linical Experienceollowing extensive animal and clinical investigation, clinicalrials using RF energy for ablation of the GSV have demon-

orrison Vein Institute, Scottsdale, AZ.ddress reprint requests to Nick Morrison, Morrison Vein Institute, 9755

tNorth 90th Street, Suite A-210, Scottsdale, AZ 85258.

895-7967/05/$-see front matter © 2005 Elsevier Inc. All rights reserved.oi:10.1053/j.semvascsurg.2004.12.006

trated excellent success, comparable to, or better than theistorical results following stripping.7 A prospective random-

zed study directly comparing RF ablation with stripping,eported by Lurie et al,8 confirmed these earlier findings.onsecutive reports from 1999 to 2000, and follow-up re-orts as long as 3 years after RF ablation have confirmed theafety and efficacy of this method of saphenous vein abla-ion.9-12 Successful saphenous ablation in nearly 90% of casess routinely reported.13

Complications following RF ablation include deep veinhrombosis (DVT), paresthesia, pain, bruising, leg edema,ocalized thermal skin injury, hematoma, and superficialhrombophlebitis.14 The most serious of these, DVT, is gen-rally reported to be less than 1%, but has recently beeneported as high as 40% in one small group of patients.15

aresthesia, reported from 2% to 16%, is usually transitory.16

eported incidence of the other complications is low.14

Between 2000 and 2001, reports from Boné, Navarro, andin of clinical trials appeared to show an unprecedented rate

f successful ablation of the GSV using laser energy.7 Three-ear follow-up data confirmed the earlier high successates.17 Other centers, including those of Proebstle et al18 andhang and Chua,19 using lasers of various wave lengths, havelso reported high rates of successful ablation.

Complications following laser ablation have been reported

o be rare or nonexistent.7,8 Specifically, DVT, paresthesia,

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nd thermal injury have not been reported. Bruising and painave been acknowledged to occur more often than in RFblation.20

ersonal Experiencet our institution, over 1,400 endovenous ablation proce-ures have been performed since 1999 (approximately,150 RF ablations and 250 laser ablations). For laserblation, we use an 810-nm diode laser. Early laser proce-ures were performed in a pulsed mode, later procedures

n continuous mode.In 2001, 50 patients with bilateral GSV reflux were

nrolled in a prospective, randomized clinical trial,herein one GSV was ablated with RF energy, the otherith laser energy. Patients were then followed closely with

nterviews, physical examinations, and duplex evaluationst intervals of 1 and 6 weeks, and at 3, 6, and 12 months.

e defined two primary endpoints: complete ablation at 1ear, with no flow detectable by color flow Doppler in anyortion of the treated segment; and recurrent patency inny portion of the treated segment, discovered anytimeuring the 1-year follow-up period. Data analysis identi-ed 40/50 RF-treated GSV, and 33/50 laser-treated GSVso be completely ablated at 1 year (P � .05). Alternatively,0/50 RF-treated GSVs, and 17/50 laser-treated GSVs

able 1 Comparative Results of Saphenous Ablation

RF EVLT P Value

rimary occlusion 40/50 33/50 <.05etained patency 10/50 17/50 <.05

bbreviations: EVLT, endovenous laser treatment; RF, radiofre-quency.

ere found to have recurrent patency some time duringhe study (P � .05) (Table 1). These results, particularlyith laser ablation, are not in agreement with published

eports. We found the laser procedure to be about 15inutes faster than RF, but associated with more postop-

rative bruising and pain.Complication rates in our overall experience were mir-

ored in the comparative trial, and are also at some vari-nce with published reports. We found the overall DVTate to be 0.8%, with approximately the same rate of oc-urrence in RF and laser procedures. Paresthesia occurredn equal proportions for each procedure (�1%), as did legdema (�1%) and superficial thrombophlebitis (2.3%).ain and bruising were more common following laser thanF ablation. Thermal skin injury and hematoma were rarefive cases overall).

djunctive Techniquesven though the primary source of a patient’s venous in-ufficiency may be an incompetent GSV, that is, by noeans, the entire extent of their disease process. Venous

nsufficiency is rarely, if ever, limited to the proximal GSV.eflux in the distal GSV, small saphenous vein, perfora-

ors, and tributaries, also plays a large role in the symp-oms and signs of venous insufficiency. Treatment of otherncompetent veins is essential to achieving good results.his often includes ambulatory phlebectomy, ultrasound-uided and visual sclerotherapy, and perforator interrup-ion. In our institution, we use ambulatory phlebectomyor bulging, superficial varicosities and ultrasound-guidedoam sclerotherapy for the distal GSV, small saphenousein, tributaries, and perforators wherever reflux is iden-ified. The subfascial endoscopic perforator surgery

Figure 1 Columns depict relative identifica-tion of reflux by each of five ultrasound ma-chines (Equip. A-E).

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Saphenous ablation 17

SEPS) for perforator ligation, and powered light-assistedransilluminated phlebectomy for bulging varicosities areethods used by other surgeons. Elimination of telangi-

ctasias is also of great importance to many patients.

ommentaryne of the difficulties in evaluating reports of successful

blation of the GSV lies in the definition of “success.”ome, especially in the RF ablation reports, define successs “no reflux in any segment longer than 5 cm.” Some lasereports refer to success as “stable occlusion” or “reductionn reflux.” while Min has applied the much clearer stan-ard of success as “no flow by color flow Doppler.”6

The major difficulty with defining success as reductionr absence of reflux is that attempts to establish whethereflux is present in a portion of a previously ablated GSV isubject to inconsistency. Most recurrent patency is seen inhe proximal portion of the treated GSV; therefore, distalompression of the closed portion of the GSV to identifyeflux in a proximal segment is futile. Likewise, using thealsalva maneuver is unreliable and lacks reproducibility.inally, the importance of distinguishing a partially patenthannel with flow, from one with reflux, is academic, be-ause the valves are just as thoroughly destroyed as the restf the vein wall.We attempted to determine if reporting of results might be

nfluenced by the quality of ultrasound equipment utilized totudy and follow patients. We conducted a study in six pa-ients with GSV reflux. All were examined by three registeredascular technologists (RVT) with extensive venous experi-nce, using five different ultrasound machines. Using a highefinition Acuson Sequoia ultrasound machine, with an 8- to3-mHz transducer, all three sonographers were able to iden-ify reflux in all six patients. They then examined the sixatients with four other ultrasound machines commonlysed in vascular labs. The results for each machine were theame for all three technologists, and successfully identifiedeflux in 85%, 77%, 69%, and 62% of the legs (Fig 1). Thistudy showed that reflux was missed by two machines inpproximately one-third of the cases This may help to ex-lain the discrepancy seen in reported results. Another factor

s illustrated by variability that we have seen in our ownascular lab. A sonographer with limited venous experience,xamining a patient, even with excellent equipment, can findt difficult to identify low-level reflux in some patients prioro treatment and even more difficult in patients who have hadblation procedures.

onclusionsnitially treated with great skepticism, reports of successfulblation of the incompetent GSV, using either radiofre-uency or laser energy, without ligation or stripping, haveteadily gained acceptance and credibility. Although it is stillarly in the follow-up period, optimism for these proceduress rising. Not only do these ablation techniques appear to be

afe and effective in the mid-term, patient acceptance of these

inimally invasive procedures is overwhelmingly better thanith stripping.Choosing which procedure to adopt can be influenced byvariety of factors that should be carefully considered: re-orted results (and especially reporting methods); economicactors, such as equipment and disposables costs, reimburse-ent, procedure time; availability of and experience withltrasound equipment and trained personnel; individualupport by industry before, during, and after acquisition ofhe generator; and the practitioner’s own level of expertisend comfort with ultrasound guided techniques, and mini-ally invasive surgery.Whichever method is chosen, the practitioner should em-

race a commitment not only to ablate the proximal GSV, buto take care of the patient’s entire venous insufficiency prob-em. Without this level of commitment, one will be left toeal with poor results and a dissatisfied patient.

eferences1. Sarin S, Scurr JH, Coleridge-Smith PD: Stripping of the long saphenous

vein in the treatment of primary varicose veins. Br J Surg 81:1455-1458, 1994

2. Goren G, Yellin AE: Minimally invasive surgery for primary varicoseveins: Limited invaginated axial stripping and tributary (hook) stabavulsion. Ann Vasc Surg 9:401-414, 1995

3. Chandler JG, Pichot O, Sessa C, et al: Treatment of primary venousinsufficiency by endovenous saphenous vein obliteration. Vasc Surg34:201-214, 2000

4. Kabnick LS, Merchant, RF: Twelve and twenty-four month follow-upafter endovascular obliteration of saphenous vein reflux: A report fromthe multi-center registry. J Phlebol 1:17-24, 2001

5. Navarro L, Min RJ, Boné C: Endovenous laser: A new minimally inva-sive treatment for varicose veins—Preliminary observations using an810 nm diode laser. Dermatol Surg 27:117-122, 2001

6. Min RJ, Zimmet SE, Isaacs MN, et al: Endovenous laser treatment of theincompetent greater saphenous vein. JVIR 12:1167-1171, 2001

7. Chandler JG, Pichot O, Sessa C, et al: Treatment of primary venousinsufficiency by endovenous sephenous vein obliteration. Vasc Surg34:201-214, 2000

8. Lurie F, Creton D, Eklof B, et al: Prospective randomized study ofendovenous radiofrequency obliteration (closure procedure) versus li-gation and stripping in selected patient population (EVOLVeS Study). JVasc Surg 38:207-214, 2003

9. Kabnick LS, Merchant RF: Twelve and twenty four month follow-upafter endovascular obliteration of saphenous vein reflux—A reportfrom the multi-center registry. J Phleb 1:17-24, 2001

0. Weiss RA, Weiss M: Controlled radiofrequency endovenous occlusionusing a unique radiofrequency catheter under duplex guidance to elim-inate saphenous reflux: A 2-year follow-up. Dermatol Surg 28:38-42,2002

1. Kistner RL: Endovascular obliteration of the greater saphenous vein:The closure procedure. J Phlebol 13:325-333, 2002

2. Nocolini P, et al: Treatment of primary venous insufficiency by en-dovenous obliteration with the VNUS Closure system. Results of amulticenter prospective study with 3 years follow-up. Eur J Vasc En-dovasc Surg. In press.

3. Pichot O, Kabnick L, Creton D, et al: Duplex ultrasound findings twoyears after great saphenous vein radiofrequency endovenous oblitera-tion. J Vasc Surg 39:189-195, 2004

4. Merchant RF, DePalma RG, Kabnick LS: Endovascular obliteration of sa-phenous reflux—A multicenter study. J Vasc Surg 35:1190-1196, 2002

5. Hingorani A, Escher E, Markevich N, et al: Deep venous thrombosisfollowing radiofrequency ablation (RFA) of greater saphenous vein

(GSV): A word of caution. Maimonides Medical Center, Brooklyn, NY,

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USA. Presented at the American Venous Forum 16th Annual Meeting,Kissimee, FL, February, 2004

6. Chandler JG, Pichot O, Sessa C, et al: Defining the role of extendedsaphenofemoral junction ligation: A prospective comparative study. JVasc Surg 32:941-953, 2000

7. Min RJ, Khilnani N, Zimmet SE: Endovenous laser treatment of saphenousvein reflux: Long-term results. J Vasc Interv Radiol 14:991-996, 2003

8. Proebstle TM, Lehr HA, Kargl A, et al: Endovenous treatment of the

greater saphenous vein with a 940 nm diode laser: Thromboticocclusion after endoluminal thermal damage by laser generated steambubbles. J Vasc Surg 35:729-736, 2002

9. Chang CJ, Chua JJ: Endovenous laser photocoagulation (EVLP) forvaricose veins. Lasers Surg Med 31:257-262, 2002

0. Min RJ: Two year follow-up results on endovenous laser treatment ofthe incompetent greater saphenous vein. Report presented at American

College of Phlebology 16th Annual Congress, November 9, 2002