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272 Chapter 29/Endovenous Laser (EVL) for Saphenous Vein Ablation
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A B
FIGURE 29.4 Thrombus protrusion detected 4 weeks after endovenous laser treatment of the Great Saphenous vein
(A) showing marked retraction 3 weeks later (B).
into the common femoral vein. It was recently reported in three of 54 limbs (5.6%) after endovenous laser cases but resolved without further complications under anticoagula­tion.23 Remarkably, despite regular duplex scanning after endovenous laser from the very beginning, in fi ve years we recorded only one case of thrombus protrusion. This single patient, remarkably, stopped his low molecular weight pro­phylaxis two days after the procedure. Thrombus protrusion was detected four weeks after the procedure and showed retraction three weeks later under anticoagulation with phenprocoumon (see Figure 29.4).
ENDOVENOUS LASER COMBINED WITH
OTHER TECHNIQUES
Endovenous laser treatment of saphenous vein can be combined with any other technique to the discretion of the phlebosurgeon. These techniques include Muller’s phlebectomy, sclerotreatment of any kind, perforator surgery, SEPS, and endovenous laser occlusion of incompetent per­forators. No need to mention that any other pathological refl ux in the groin, like refl ux in the anterior accessory Great Saphenous vein must be treated concomitantly to ablation of the saphenous vein. Certainly, this also can be done by endovenous laser treatment. However, some surgeons are convinced by the role of subtle ligation of the Great Saphe­nous vein and all other superfi cial inguinal veins at the saphenofemoral junction. Therefore they perform a cros­sectomy in conjunction with endovenous laser treatment of the Great Saphenous vein. In the meantime some examples can be found in the literature for such a strategy. results of larger comparative trials randomizing endovenous
6,8
However,
laser against endovenous laser plus crossectomy would be of great help in future discussions.
CONCLUSION
In conclusion, endovenous laser of saphenous veins has left the stage of an experimental procedure, and many details have become obvious, which helped to optimize treatment results. However, prospective randomized trials of endove­nous laser treatment versus traditional surgery, versus high ligation performed at the same treatment session, or against other endovenous techniques like radiofrequency closure or sclerotreatment are still missing but urgently needed.
Acknowledgment
Thanks to Drs. Sylvia Herdemann, Doendue Guel, and Thomas Moehler for providing tremendous amounts of follow-up data of endovenous laser patients.
References
1. Navarro L, Min R, Boné C. Endovenous laser: A new minimally
invasive method of treatment of varicose veins—Preliminary observa­tions using an 810 nm diode laser, Dermatol Surg. 2001. 27: 117–
122.
2. Proebstle TM, Gül D, Kargl A, Knop J. Endovenous laser treatment of
the lesser saphenous vein with a 940 nm diode laser—Early results, Dermatol Surg. 2003. 29: 357–361.
3. Mundy L, Merlin TL, Fitridge RA, Hiller JE. Systematic review of
endovenous laser treatment for varicose veins, Brit J Surg. 2005. 92: 1189–1194.
4. Proebstle TM, Lehr HA, Kargl A, Espinola-Klein C, Rother W, Bethge
S, Knop J. Endovenous treatment of the greater saphenous vein with
References 273
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a 940 nm diode laser: Thrombotic occlusion after endoluminal thermal damage by laser generated steam bubbles, J Vasc Surg. 2002. 35: 729–736.
5. Gerard J-L, Desgranges P, Becquemin J-P, Desse H, Melliere D. Fea­sibility of ambulatory endovenous laser for the treatment of greater saphenous varicose veins: One-month outcome in a series of 20 out­patients, J Mal Vasc. 2002. 27: 222–225.
6. Chang CJ, Chua JJ. Endovenous laser photocoagulation (EVLP) for varicose veins, Lasers Surg Med. 2002. 31: 257–262.
7. Roggan A, Friebel M, Dorschel K. Optical properties of circulating human blood in the wavelength range 400–2500 nm, J Biomed Opt.
1999. 50: 532–539.
8. Corcos L, Dini S, DeAnna D, Marangoni O, Ferlaino E, Procacci T et al. The immediate effects of endovenous diode 808-nm laser in the greater saphenous vein: Morphologic study and clinical implications, J Vasc Surg. 2005. 41: 1018–1025.
9. Weiss RA. Comparison of endovenous radiofrequency versus 810 nm diode laser occlusion of large veins in an animal model, Dermatol Surg.
2002. 28: 56–61.
10. Proebstle TM. Energy delivery and pullback rates during EVL: How does one decide? International Vein Congress, Miami, Apr 14–16,
2005.
11. Proebstle TM, Sandhofer M, Kargl A, Guel D, Rother W, Knop J. Thermal damage of the inner vein wall during endovenous laser treat­ment: Key role of energy absorption by intravascular blood, Dermatol Surg. 2002. 28: 596–600.
12. Labropouplos N, Bhatti A, Leon L, Borge M, Rodriguez H, Kalman P. Neovascularization after great saphenous vein ablation. Eur J Endo­vasc Surg. 2006. 31: 219–222.
13. Min RJ, Zimmet SE, Isaacs MN, Forrestal MD. Endovenous laser treatment of the incompetent greater saphenous vein, J Vasc Intervent Radiol. 2001. 12: 1167–1171.
14. Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphe­nous vein refl ux: Long-term results, J Vasc Interv Radiol. 2003. 14: 991–996.
15. Proebstle TM, Gül D, Kargl A, Knop J. Non-occlusion and early reopening of the great saphenous vein after endovenous laser treatment is fl uence dependent, Dermatol Surg. 2004. 30: 174–178.
16. Timperman PE, Sichlau M, Ryu RK. Greater energy delivery improves treatment success of endovenous laser treatment of incompetent saphe­nous veins, J Vasc Intervent Radiol. 2004. 15: 1061–1063.
17. Timperman PE. Prospective evaluation of higher energy great saphe­nous vein endovenous treatment, J Vasc Interv Radiol. 2005. 16: 791–
794.
18. Bone C, Navarro L. Endovenous laser: A new minimally invasive technique for the treatment of varicose veins, An Cir Cardiaca Cir Vasc.
2001. 29: 357–361.
19. Proebstle TM, Gül D, Lehr HA, Kargl A, Knop J. Infrequent early recanalization of the greater saphenous vein after endovenous laser treatment, J Vasc Surg. 2003. 38: 511–516.
20. Goldman MP, Mauricio M, Rao J. Intravascular 1320 nm laser closure of the great saphenous vein: A six- to 12-month follow-up study, Dermato Surg. 2004. 30: 1380–1385.
21. Proebstle TM, Moehler T, Guel D, Herdemann S. Endovenous laser treatment of the greater saphenous vein using a 1320 nm laser causes less side effects than using a 940 nm diode laser, Dermatol Surg. 2005. 31: 1678–1683.
22. Timperman PE. Arteriovenous fi stula after endovenous laser treatment of the short saphenous vein, J Vasc Interv Radiol. 2004. 15: 625–
627.
23. Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: Analysis of early effi cacy and complications, J Vasc Surg. 2005. 42: 488–493.
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CHAPTER
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30
Effects of Different Laser Wavelengths on
Treatment of Varices
LOWELL KABNICK
INTRODUCTION
Varicose veins are a common problem in the United States, affecting mostly women and those over age 50.1 They may be benign or painful, disabling, unattractive, and dan­gerous to patient health. Varices arise when the valves in superfi cial veins malfunction, causing deoxygenated blood to refl ux and pool and the veins to swell under increased pressure, usually in the lower extremities. Insuffi ciency of the Great Saphenous vein (GSV) frequently is found to be the cause, although refl ux of the Small Saphenous vein (SSV), perforator veins, and junctional tributaries also may lead to varicose veins.
Traditional treatment for varicose veins involves invasive surgical ligation and stripping of the affected vein; although effective, this approach carries all the risks and expenses of surgery and requires prolonged and complicated recovery periods. laser ablation (EVLA) and radiofrequency (RF) ablation have emerged as effective outpatient treatment approaches that enjoy greater patient acceptance compared to surgical stripping. destroy the vein, although their mechanisms of action do differ.
ing local anesthesia only. EVLA produces excellent cos­metic results and reductions in preoperative symptoms with no impact on patient mobility and almost no complica­tions. effective than RF in the short term,10 and is less expensive than either RF or stripping.
placement of a laser fi ber and the controlled release of thermal light energy, damaging the endothelium and leading
1,2
In recent years, minimally invasive endovenous
3
Both methods deliver electromagnetic energy to
4
This chapter focuses on EVLA, a short procedure requir-
5–10
In addition, EVLA appears to be slightly more
11
EVLA, fi rst described in 1989,12 involves the intravenous
to thrombosis and resorption of the vessel. In 2002 the FDA approved EVLA for the treatment of varicose veins,1 and today lasers of several wavelengths are available for use, all of which produce excellent results. Nonetheless, some dif­ferences have been noted, particularly in terms of short-term outcomes such as bruising and postprocedural pain. This chapter describes the basics of lasers and EVLA, then com­pares results among lasers of different wavelengths, includ­ing data from a recent clinical trial.
LASER BACKGROUND
Since the fi rst working laser was made in 1960 at Hughes Research Laboratories in Malibu, California,13 laser technol­ogy has been applied to endeavors as varied as large-scale engineering projects and microscopic surgical procedures— depending on its design, a laser can cut through steel or make incisions smaller than the size of a cell. Today, lasers are familiar sources of focused light energy, useful in med­icine, technology, and meeting presentations.
The word laser is actually an acronym for Light Ampli­fi cation by Stimulated Emission of Radiation. Light in this context refers not only to visible light, but to the entire spectrum of electromagnetic radiation, of which visible light is only a small part. Each type of light has a specifi c wave­length, which determines its properties (see Table 30.1). For example, light with a wavelength of 410 nm is seen as violet, whereas light of 680 nm is seen as red. of visible light are wavelengths shorter than we can see— ultraviolet, gamma, and x-rays—and wavelengths longer than we can see—infrared, microwaves, and radio waves. The lasers discussed in this chapter emit infrared light with wavelengths ranging from 810 nm to 1320 nm.
14
Beyond the range
The Vein Book
275
All rights of reproduction in any form reserved.
Copyright © 2006, Elsevier Inc.
276 Chapter 30/Effects of Different Laser Wavelengths on Treatment of Varices
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TABLE 30.1 Spectrum of Electromagnetic Radiation
Type of wave Wavelength (cm)
Radio <10 Microwave 10 to 0.01 Infrared 0.01 to 7 × 10 Visible 7 × 10−5 to 4 × 10 Ultraviolet 4 × 10−5 to 10 X-ray 10−7 to 10 Gamma Ray <10
FIGURE 30.1 Wavelength is the distance between repeating points on
a wave pattern.
15
16
5
5
7
9
9
TABLE 30.2 Lasers Used in Endovenous Laser Ablation
of Varice
Diode lasers
EVLTTM FDA Approval: 2002 Manufacturer: Diomed, Andover, MA Wavelength: 810 nm
Medilas D Compact Diode FDA Approval: 2003 Manufacturer: Dornier MedTech Laser GmbH, Germering, Germany Wavelength: 940 nm
ELVeSTM FDA Approval: 2002 Manufacturer: Biolitec, Inc., East Longmeadow, MA Wavelength: 810 nm, 980 nm
VenaCureTM FDA Approval: 2002 Manufacturer: AngioDynamics, Queensbury, NY Wavelength: 810 nm, 980 nm
Vari-Lase® FDA Approval: 2003 Manufacturer: Vascular Solutions, Minneapolis, MN Wavelength: 810 nm
The principle behind laser technology is a quantum mechanical effect called stimulated emission, which was discovered by Einstein in 1917.17 During stimulated emis­sion, photons (discrete packets of light energy) are generated to produce a focused, coherent beam of light consisting of a single wavelength; in contrast, common light sources such as lightbulbs produce incoherent light, emitting photons in many directions over a wide spectrum of wavelengths (see Figure 30.1). For both types of light the amount of energy used is measured in joules (watts × sec) and the power (rate of energy use) is measured in watts (joules per second); however, a 40 watt laser will appear much brighter than a 40 watt lightbulb, for example. Another difference is that lasers can emit light either continuously or in pulses of higher peak powers, whereas regular light cannot be con­trolled in that way.
13
A typical laser consists of three main parts: a laser medium, a pump source, and an optical resonator.18 The wavelength a laser produces depends on the type and design of the medium and also on the alignment of mirrors in the optical resonator.
The laser medium (also called gain medium) emits
photons when excited; it can be a solid, liquid, or gas.
The pump source provides energy that excites the lasing
medium; it may be an electrical discharge, a fl ashlamp, or another laser.
Nd:YAG lasers
CoolTouch CTEVTM FDA Approval: 2005 Manufacturer: CoolTouch, Roseville, CA Wavelength: 1320
The optical resonator (also called optical cavity) is a
mirror or system of mirrors that intensifi es and amplifi es light emitted from the medium; it does this by refl ecting light back into the medium, sometimes several times, before it exits the laser.
LASERS USED IN EVLA
There are many types of lasers available, distinguished broadly by whether their medium is solid, liquid, or gas. The lasers used in EVLA (see Table 30.2) are all solid-state lasers of two types: diode and Nd:YAG.
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FIGURE 30.3 With Nd:YAG lasers, the medium is a solid crystal and
the pumpsource is a fl ashlamp or other light source, such as a diode
22
FIGURE 30.2 A diode laser uses a semiconductor and electrical current
to produce a coherent light beam of a single wavelength. (Courtesy of Biolitec.)
laser.
lasers will be discussed, although the 1064 nm normally is not used in the United States for EVLA.
Diode lasers (see Figure 30.2) are a common type of
laser, such as you would fi nd in your CD player or laser
EVLA MODE OF ACTION
pointer, that use electrical current as their pump source. Their medium is a very thin, microscopic chip known as a semiconductor, which consists of two layered wafers of semiconducting crystals (e.g., silicon) cleaved at both ends with smooth parallel edges that act as mirrors.19 The two wafers each have different electrical properties—one pro­duces electrons and one produces the absence of electrons, known in solid-state physics as a hole.20 Both wafers are extremely conductive, but the space between them, known as the p-n junction, is not. However, applying electrical voltage to the p-n junction can reduce the width of the junc­tion, thereby making the exchange of electrons and holes possible and resulting in the emission of photons.
19,20
By manipulating the p-n junction, diode lasers allow electrical current to fl ow in one direction, but not the other.
Diode lasers have several advantages, including their high degree of electrical effi ciency, compact and convenient construction, and high-speed operation; however, their output beams can be highly divergent and their peak ener­gies are lower than what is required for some medical appli­cations, although this last point can be overcome by tightly stacking together many small laser emitters. The diode lasers covered in this chapter have wavelengths of 810 nm, 940 nm, and 980 nm.
The other type of laser used in EVLA is the Nd:YAG laser (see Figure 30.3), the workhorse of solid-state lasers.
The use of lasers to treat varicose veins is a relatively new application of laser technology, and the mode of action is not thoroughly understood. In general, the combination of intense thermal reaction and boiling blood is considered to be the mechanism of endovenous injury. During the proce­dure, the intravenously placed laser fi ber emits infrared light that converts to heat, exceeding the boiling point of hemo­globin or water and boiling the blood.
8,23
The hot blood delivers extensive, thermal damage to the endothelium, which in turn becomes thrombotic and the vein occludes.8 Although boiling bubbles and thrombosis are key in the EVLA mode of action, there appears to be no risk of embo­lism and a small risk of deep vein thrombosis (DVT) associ­ated with the procedure.
8
Each laser has a target molecule, known as a chromo­phore, that absorbs light of its particular wavelength (see Figure 30.4). The chromophore of 810-nm lasers is hemo-
24,10
globin; and water;
940 nm and 980 nm lasers affect both hemoglobin
24,10
and 1320 nm lasers target water alone.25 To be effective, the lasers must be able to penetrate hemoglobin, water, or both to the point where suffi cient energy is absorbed by the chromophore to generate a thermal reaction releasing steam bubbles.10 Regardless of the type of laser, the intense thermal reaction and that boiling of blood is distributed along the inner vein wall.
10
Nd:YAG is an acronym for the medium used, a crystalline material called neodymium-doped yttrium aluminum garnet.
21
The medium is in the shape of a thin rod, which is
EVLA PROCEDURE
fl anked by a pair of mirrors. Rather than using electrical current as a pump source, Nd:YAG lasers are pumped by another light source, such as a diode laser or a fl ashlamp, and are able to build up and release energy to facilitate focusing on very small areas; however, they are larger, more complex to operate, and less electrically effi cient than diode lasers. In this chapter the 1320-nm and 1064-nm Nd:YAG
Although EVLA is applicable to refl uxes of veins other than the GSV, treatment of this vein is particularly common; therefore, this chapter describes the procedure using the GSV as an example.
26
The surgical technique is similar for both diode and Nd:YAG lasers, with only slight modifi ca­tions necessary when Nd:YAG lasers are used. Regardless
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FIGURE 30.4 Light is absorbed by different chromophores depending
on its wavelength. (Courtesy of Donier, MedTech, America Inc.)
FIGURE 30.6 The tip of the fi ber is visible using ultrasound.
FIGURE 30.5 A 4-French sheath is inserted into the GSV, just above the
knee.
of the laser, the procedure begins by the patient lying supine on a surgical table and being draped in the sterile mode. Local anesthetic is then administered to the skin to provide anesthesia.
Ultrasound-guided access to the GSV is then obtained, either at or below the knee, using a 21-gauge micropuncture catheterization set. A 5 F micro-sheath introducer is inserted into the GSV (see Figure 30.5). After removing the inner cannula from the micro-sheath, a .035-inch guidewire is advanced beyond the saphenofemoral junction (SFJ) into the common femoral vein, again under direct ultrasound guid­ance. A 45-cm or 65-cm 4- or 5-French sheath is then marked at the point of length of insertion, backloaded onto the guidewire, and advanced to 1.5 cm below the SFJ or just distal to the epigastric vein.
After the sheath is stabilized, the introducer and guide­wire are removed and a 600-micron bare-tipped laser fi ber is placed into the sheath. The laser fi ber is then advanced to the end of the sheath by ultrasound guidance and the sheath is retracted. When using a diode laser, the sheath is retracted
FIGURE 30.7 Tumescent anesthesia should place the vein to be treated
approximately 10 mm from the skin and fi ll an area around the catheter that is approximately 10 mm in diameter.
to the fi ber’s locking device and married, leaving the tip of the laser exposed; with the Nd:YAG 1320-nm laser, the sheath is retracted completely. Final laser position easily is determined by ultrasound (see Figure 30.6) and can also be verifi ed directly because the skin becomes luminous where the laser tip, or aiming beam, emerges from the end of the sheath. The area around the entire venous segment being treated is then infused with dilute local anesthesia under ultrasound guidance; the infusion should create an ultra­sound-verifi ed 10-mm hypoechoic diameter around the vein and a suffi cient amount of tumescent anesthesia to approximate a 10 mm distance from the skin to the vein (see Figure 30.7).
After the correct position of the laser is verifi ed, laser energy is delivered at a determined wattage while the fi ber is pulled back down the length of the vein. Laser manufac-
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turers provide guidelines on the amount of power that should be used during EVLA; however, medical practitioners adjust the standards according to their professional experience and judgment. Laser energy can be emitted either continu­ously with constant, gentle pullback of the fi ber, or in a pulsed mode with energy emitted only when the laser is held still, not when it is moving.8 Pullback may be performed either by hand in the case of diode lasers or an automatic pullback machine in the case of Nd:YAG lasers. In either case, pullback rate is determined by the watts used and energy rate (joules/cm) required. With diode lasers, watts are set in the range of 10–14 and joules/cm are set in the range of 50–80; with Nd:YAG lasers, watts are between 5–7 and the energy rate is between 50–70 joules/cm (the automatic pullback device is usually set a 1 mm/sec). After the entire venous section has been treated with laser energy, the vein is then checked by ultrasound for closure and any abnormalities.
The puncture sight is covered with a sterile dressing and a full-thigh Class 2 compression stocking (30–40 mmHg) is placed on the leg. There is variation between physicians regarding how long the patient is told to wear the stocking; a suggested recommendation is to wear the stocking until the next evening and while awake for the next 7 to 10 days after that. The patient is also instructed to take ibuprofen for pain and to avoid high-impact aerobics.
EVLA CLINICAL OUTCOMES BASED
ON LASER WAVELENGTH
Scientifi c studies on the safety and effi cacy of EVLA are appearing more frequently in the literature, although to date there has been only one randomized, double-blind, prospec­tive trial.26 The literature that is available can be diffi cult to assess, since authors frequently use different measurements of outcome, and certainly the parameters of treatment vary between centers. In general authors look for complication and closure rates, although defi nitions of closure vary among trials from “no refl ux” to “no fl ow verifi ed by ultrasound.” In addition, the physician must consider equally important symptom and quality-of-life outcomes, jective and nonstandardized in the literature. Nonetheless, midterm clinical trial results are available and long-term experience is beginning to accumulate.
There is no scientifi c evidence that wavelength has any effect on long-term outcome (see Table 30.3), although in the short term differences can be found for some side effect rates. Clinical trial experience with the diode lasers has produced extremely low rates of DVT and paresthesia, apparently no skin burning, and no documented cases of
7,27,28,29
pulmonary embolism;
both paresthesia and skin burns have been associated with 1064 nm laser treatment.30 The most common side effects seen with all laser types are bruis-
4
which are both sub-
ing, localized pain, induration and discomfort along the treated vein, and superfi cial phlebitis.
One trial has evaluated the parameters associated with successful occlusion at three-month follow-up.31 Consecu­tive patients with incompetent GSV received EVLA using a 940-nm diode laser administered continuously with a pull­back rate of 5–10 mm/second. Analysis showed that factors infl uencing whether veins remained closed at three months were higher laser fl uence (J/cm2), higher energy per vein length (J/cm), shorter distance from thrombus to SFJ at day 1 after EVLA, smaller proximal vein diameter, and longer total laser treatment time (see Table 30.4). Obviously outcome is also dependent on careful patient evaluation, treatment discussions, and long-term follow-up.
1
810 nm VS 980 nm: A RECENT REPORT
To further determine whether EVLA outcomes are related to laser wavelengths, a randomized, double-blinded, pro­spective, single-center trial was undertaken in patients elect­ing EVLA for GSV insuffi ciency.26 Prior to treatment, patients completed an evaluation of limb pain, rated on a scale of 1 to 5, where 1 was “no pain” and 5 was “intense pain”; patients also completed an evaluation of the physical and emotional impact of their leg problems on their daily living.
Fifty-one patients underwent the procedure as described earlier in this chapter; 30 limbs were treated with a 810-nm laser and 30 with a 980-nm laser. Immediately following the procedure and again at 72 hours the treated vessels were confi rmed closed using duplex ultrasound. At 72 hours, three weeks, and four months patients completed a survey of physical activity and underwent an examination of symptoms.
No differences in outcome or in any physical activity or symptom survey items were apparent at 72 hours following the procedure. As follow-up continued, patients in the 810­nm group experienced more bruising at one week (P =
0.007) and worse pain intensity (P = 0.028) and varicose vein ratings (i.e., visible varices) (P = 0.004) at four months, but signifi cantly less itching at three weeks (P = 0.031). Ten patients in the 810-nm group and three patients in the 980­nm group experienced phlebitis of the treated vein, which was directly related to increased postprocedural pain. At one year, two legs in each group exhibited refl ux by duplex ultrasound using the compression and release method, indic­ative of returned fl ow in the GSV. All other limbs remained free of fl ow at their one-year follow-up, for a success rate of 93%.
This trial shows that both the 810-nm and the 980-nm lasers are effective with no complications or adverse events. Although there was a short-term trend in favor of the 980­nm laser, those differences did not lead to the need for
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TABLE 30.3 EVLA Outcomes by Laser Wavelength
Diameter of pretreatment Complete Veins vein, mm occlusion Author, treated range rate % year Design of trial (patients) (mean) Parameters Follow-up (patients/n) Side effects
7
Min, 2001
Prospective, 90 GSV 3–27 (11) 10–12 W, 1 week 97 (87/90) Self-limiting bruising, nonrandomized, (84) pulse mild discomfort, consecutive duration 1–9 months 99 (89/90) soreness along enrollment 0.8–1.0 (6 months, GSV, paresthesia multicenter seconds mean) in one patient Min, 2003
32
Prospective, 499 (423) 4.4–29 (11) 55% of limbs 1 month 98 (490/499) Bruising, tightness or nonrandomized treated with pulling along GSV, consecutive 14 W 6 months 99 (390/396) superfi cial phlebitis enrollment continuous of varicose single center mode, mean 1 year 98 (310/318) tributaries delivery of laser energy 123 sec, 2 years 93 (113/121) 1727 J Min, 2004
33
Prospective, 1000 4.1–38 (10) 14 W <1 year 96 (309/322) Bruising and mild nonrandomized (925); continuous tenderness consecutive 811 GSV, mode, 100% enrollment 80 SSV, success if >3 years 99 (218/219) single center 96 AASV, treated 13 PASV with >70 J
Proebstle 200234 Prospective, 109 GSV Not available 15 J 1 year 90 (94/104) Pain and induration consecutive (85) administered along the vein, enrollment in 1 second symptoms of pulses thrombophlebitis Proebstle 20028 Patients 31 (26) 4.0–9.9 (6) 15 W, pulsed 28 days 97 (30/31) Moderate bruising, selected from (1 second on, slight-to-moderate phlebology 2 seconds off) local pain, clinic induration along the vein Proebstle, 200328 Patients 41 (33) 2.0–6.0 (3.4) 15 W 1 day 100 (39/39) Pain, bruising, selected from intended; continuous induration, phlebology 39 (31) pullback 6 months, 100 (37/37) paresthesia, clinic completed 0.5–1 cm/sec; median periphlebitis, DVT or 15 J with in one patient 1-second pulses
Kabnick, 2002
35
Patients with 20 GSV Not available 12 W, Immediate 100 (20/20) Bruising, discomfort GSV refl ux (15) pullback rate or pain, superfi cial confi rmed 10–12 cm/min phlebitis by duplex ultrasound Oh, 20039 Patients of 15 GSV Not available 10–12 W in 1, 4, and 100 (15/15) Bruising, mild phlebology (12) pulsed 12 weeks tenderness, clinic chose fashion with induration, either traditional 1–2 seconds superfi cial surgery or thrombophlebitis EVLA in one patient Kabnick, 200429 International 7611 Not available Not available Not 96 Bruising, paresthesia, Registry limbs, available burns 0.5%, DVT 7061 GSV 0.3%
810 nm Wavelength
940 Wavelength
980 nm Wavelength
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TABLE 30.3 (continued)
Diameter of pretreatment Complete Veins vein, mm occlusion Author, treated range rate % year Design of trial (patients) (mean) Parameters Follow-up (patients/n) Side effects
26
Kabnick, 2005 double-blind, laser: continuous 93 (28/30) bruising, itching single-center 30 GSV pullback at 980 nm 50 joules/cm 1 year 980 laser: laser: 93 (28/30) 30 GSV
Chang, 2002 10-second (19 bruising, lower­ pulse duration months, limb swelling, mean) dyschromia, superfi cial burns and phlebitis, hematomas
Goldman, 2004 consecutive (22) second months bruising not automatic (8 months, mentioned pullback mean)
W = watts; J = joules; GSV = Great Saphenous vein; SSV = Small Saphenous vein; AASV = anterior accessory saphenous vein; PASV = posterior
accessory saphenous vein; LSV = lesser saphenous vein
Randomized, 810 nm Not available 10 W, 1 year 810 laser: Phlebitis, pain,
30
Not available 252 (149) Not available 10–15 W, 1–2 years 97 (244/252) Local paresthesia,
2
Prospective, 24 GSV 0.5–1.2 5 W, 1 mm/ 6–12 100 No pain or phlebitis,
810 nm Vs 980 nm Wavelength
1064 nm
1320
TABLE 30.4 Parameters and EVLA Outcome at Three
Months Using a 940-nm Laser
Median value of parameter
Parameter Closed veins Open veins P value
Laser fl uence (J/cm2) 13.2 7.2 <.001 Energy per vein length (J/cm) 23.8 19.3 .004 Distance thrombus to SFJ 1.1 2.5 .004 at day 1 after EVLA (cm) Proximal vein diameter (cm) 0.64 0.90 .002 Total laser time (seconds) 91.0 72.3 .046
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additional treatment or to any difference in long-term out­comes between the two treatment groups. This study con­fi rms earlier published reports showing few complications associated with the 810-nm and the 980-nm lasers in EVLA.
ONGOING RESEARCH BY THE AUTHOR
A clinical trial is under way comparing EVLA using 980­nm or 1320-nm lasers and RF ablation. To date, no trial has adequately compared these three treatment methods, although discussion abounds as to the advantages and draw-
TABLE 30.5 Signifi cant Differences between 810 nm and
980 nm Outcomes in EVLA
810 nm 980 nm Outcome parameter Mean (n) Mean (n) P value
Bruising at 1 week* 2.4 (30) 1.55 (3) .0047 Itching at 3 weeks† 0.167 (30) 0.50 (30) .031 Pain intensity at 4 months† 1.5 (30) 1.21 (30) .028 Varicose vein rating at 4 months† .97 (30) .31 (30) .004 Phlebitis 10 (30) 3 (29) .08
*Based on a 5-point scale, where 0 = no visible bruising and 5 = extreme
bruising.
†Based on a 4-point scale ranging from absent to severe.
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backs of each. The trial is a randomized, double-blind, pro­spective trial with methods similar to the trial described earlier; it is expected that results may help further differen­tiate these noninvasive treatment methods for varices.
CONCLUSION
Although clinical trial experience is limited and there is no standardized system for evaluating EVLA outcomes, it is clearly effective and safe in the treatment of varices (see Table 30.5). There is no scientifi c evidence demonstrating superior long-term results using one laser wavelength over