Endovenous laser treatment for uncomplicated varicose veins

Phlebology 2009;24:50-61
doi:10.1258/phleb.2009.09s006
© 2009 Royal Society of Medicine Press

 

This Article

Abstract

Full Text (PDF)


Alert me when this article is cited

Alert me if a correction is posted
Services

Email this article to a friend

Similar articles in this journal


Similar articles in PubMed

Alert me to new issues of the journal

Download to citation manager

Citing Articles

Citing Articles via HighWire

Citing Articles via Web of Science (1)

Citing Articles via Google Scholar
Google Scholar

Articles by Darwood, R J

Articles by Gough, M J
Search for Related Content
PubMed

PubMed Citation
Social Bookmarking

What’s this?


Original Articles


R J Darwood and
M J Gough 


Leeds Vascular Institute, The General Infirmary at Leeds, Leeds, UK

Correspondence: M J Gough ChM FRCS, Consultant Vascular Surgeon, Leeds Vascular Institute, The General Infirmary at Leeds, Great George Street, Leeds LS13EX, UK. Email: michael.gough{at}leedsth.nhs.uk

Abstract

Objective: Endovenous laser ablation (EVLA) of incompetent truncal veinshas been proposed as a minimally invasive alternative to conventionalsurgery for varicose veins. Various strategies have been proposedfor successful treatment and this study reviews the evidencefor these.

Method: A Medline and ‘controlled trials online database’search was performed to identify original articles and randomizedcontrolled trials (RCTs) reporting outcomes for EVLA. Informationon patient selection, equipment, technique and outcomes wererecorded.

Results: Ninety-eight original studies, including five RCTs, were identified.RCT data indicate short-term outcomes (abolition of reflux,improvement in quality of life [QOL], patient satisfaction)were equivalent to those for surgery. Long-term follow-up isnot available. A further RCT showed superior outcomes for ablationcommencing at the lowest point of superficial venous refluxrather than at an arbitrary point (fewer residual varicosities,greater improvement in QOL).

Non-randomized series suggest that laser energy of >60 J/cmresults in reliable truncal vein occlusion and that longer wavelengthlasers may be associated with less post-treatment discomfort.

Conclusion: In the short-term EVLA is a safe and effective treatment forpatients with varicose veins. Long-term follow-up is still required.

Key Words: varicose veins • great saphenous vein • small saphenous vein • endovenous laser • EVLA • treatment


Search methods for systematic review

A Medline search was performed using the database 1950-todayand the keywords ‘endovenous’ OR ‘varicoseAND veins’ OR ‘vein OR venous, AND insufficiencyOR disease OR incompetence OR reflux’ AND ‘laser’.This yielded 455 articles of which 152 related to endovenouslaser therapy of varicose veins. Ninety-eight of these wereoriginal studies including five randomized controlled trials(RCTs).

All registers on the controlled trials online database (see www.controlled-trials.com) were searched using the keywords ‘endovenous laser’. This yielded 13 studies of which five were duplicates. Two had been published,1,2 five are awaitingpublication and one is still in progress (expected completiondate 2011).


Description of technique

Endovenous laser treatment (EVLTTM) was first described by Navarro in 20013 using an 810 nm diode laser. EVLTTM is a trademarkreferring to a specific 810 nm diode laser and thus the termendovenous laser ablation (EVLA) will be used throughout thisdocument.

Laser is an acronym for ‘light amplification by stimulatedemission of radiation’. Monochromatic (single wavelength)light is emitted from a laser medium (both diodes and Neodymlum-dopedyttrium aluminium garnet [Nd:YAG] are used for EVLA) and amplifiedby mirrors.

EVLA involves insertion of a laser fibre into the incompetenttruncal vein (usually great [GSV] or small saphenous vein [SSV])with subsequent thermal ablation of the vein. This should achievethe same effect as saphenofemoral or saphenopopliteal ligationtogether with stripping of the truncal vein.


Patient selection

Although EVLA was initially used to treat GSV reflux there are several large series describing successful SSV47 and anterior saphenous vein ablation.8,9 There are also isolated reports of treatment of incompetent perforating veins10,11 and varicosities themselves.12


Exclusion criteria

Patient factors:

  • Unsuitable for local anaesthetia;
  • Peripheral arterial disease where both truncal vein ablation and compression bandaging may be inappropriate;
  • Pregnancy or breast-feeding.

Anatomical factors:

  • Tortuosity;
  • Thrombophlebitis.

 

Most authors exclude patients with deep vein occlusion, andsome those with deep vein incompetence (a relative contraindication).Patients with large diameter veins may also be excluded, althoughMin (personal communication) has treated veins of up to 35 mmdiameter. Warfarin therapy, coagulation disorders or other medicalcomorbidity may also lead to exclusion, although an unpublishedseries has indicated that EVLA is effective in patients takingwarfarin. There is little published evidence to support or refutethe other criteria. Further, it is the authors’ view that patientswith large tributaries arising <10 cm from the truncal/ deepvein junction may not experience an optimal outcome.


Anaesthesia

EVLA is usually performed using tumescent local anaesthesia, which provides analgesia, compresses the vein thus enhancing contact between the vein wall and laser fibre, and protects surrounding tissues from thermal damage. When tumescent anaesthesia is omitted there is a high incidence of nerve damage (saphenous or sural nerves) and skin burns.13 Although reported infrequently,oral or intravenous sedation may be administered and rarelyepidural or general anaesthesia is used. The latter prolongrecovery and increase procedure costs. There are no studiescomparing the risks or benefits of different anaesthetic techniques.

Most authors have used dilute lidocaine for tumescent anaesthesia, which may be neutralized with bicarbonate to reduce pain on injection.14,15 Although this can also be achieved by warming the solution to body temperature,16 this will reduce the protective ‘heat-sink’ effect of the tumescent anaesthesia. The maximum recommended dose of lidocaine is 3 mg/kg without adrenaline and 7 mg/kg with adrenaline, but doses of 35 mg/kg lidocaine have been safely used for tumescent anaesthesia in plastic surgery.17 For EVLA around 300 mL per limb at 0.1–0.2% concentration is normally used. In order to avoid the risk of lidocaine toxicity, Chong et al. have described the use of cold saline rather than local anaesthetic for tumescence.18 If lidocaineis used, it is important to be alert for signs of toxicity.


Patient position

For GSV ablation, the patient lies supine with the hip partiallyflexed and externally rotated. A pillow or small foam wedgeplaced under the pelvis/lower back on the opposite side is usedto turn the patient towards the limb for treatment. For SSVablation, the patient is positioned in the prone position.


Venous access

The vein for ablation is cannulated percutaneously under ultrasoundguidance with the patient in the reverse Trendelenberg positionto maximize vein diameter. Thus a tilting table is recommended.Once the fibre is correctly positioned the table is moved tothe Trendelenberg position to empty the vein of blood priorto ablation. If percutaneous cannulation proves difficult thevein may be hooked to the skin surface (Oesch phlebectomy hook)via a small stab incision and cannulated under direct vision.This is difficult for the SSV as it lies deep to the fasciain the calf.


The great saphenous vein

The original reports for GSV EVLA described cannulation at the level of the knee joint, mimicking the current practice for limiting stripping of the vein to reduce the risk of saphenous nerve injury. However, when below-knee GSV reflux persists post-ablation, the improvement in symptoms scores is less.19 Further, a RCT comparing above-knee EVLA alone with above and below-knee EVLA (from the lowest point of reflux) in patients with below-knee GSV incompetence has confirmed a superior symptomatic outcome in the latter with only 17% of patients having residual varicosities requiring delayed sclerotherapy (versus 61% for above-knee ablation).20This trial also included a third treatment group (who underwentabove-knee EVLA with foam sclerotherapy to the below-knee GSV).Although this was not as effective as ‘full-length’EVLA, it was superior to above-knee EVLA alone and is recommendedfor patients with a tortuous below-knee GSV that precludes successfulEVLA.

There is one report describing proximal GSV access after percutaneous cannulation of the contralateral groin. This appears to offer little benefit and requires fluoroscopy and enhanced catheter skills.21


The small saphenous vein

This is usually accessed in the distal calf, preferably abovethe distal third (where the sural nerve is closely adherent)to reduce the risk of nerve injury.


Anterior accessory saphenous vein

The anterior saphenous vein may also be suitable for EVLA either alone or in addition to GSV ablation if this is also incompetent. Suitability is limited to those patients who have a relatively straight segment of vein (10 cm or more) between the SFJ and the varicosities. One report describes good outcomes for such patients although additional sclerotherapy or phlebectomies are often required.22


Positioning the fibre tip

Accurate positioning of the catheter tip (and thus the laser fibre) close to the saphenofemoral (SFJ) or sapheno-popliteal junction (SPJ) but not within the deep vein is vital. The optimal distance from the junction has not been determined, but 1 cm seems appropriate. This can only be achieved with duplex ultrasound and while there are reports in which the tip of the laser fibre is positioned using the aiming beam,13 this is potentially dangerous and cannot be recommended. Some have debated whether the fibre should be positioned proximal or distal to the superficial epigastric vein (which may not be easy to visualize) although there is no evidence to show a benefit in relation to this. Data from Theivacumar et al.23 has shown that a policy of locating thefibre 1 cm distal to the SFJ results in flush GSV/SFJ occlusionwith no patent tributaries in 40% of limbs. In the remainder,one or more patent tributaries were visible but all were competent.Persistent non-refluxing GSV tributaries at the SFJ did notappear to have an adverse impact on clinical outcome one yearafter successful GSV ablation and were not associated with recurrence.

Once positioned, the fibre should be locked to the catheterto prevent movement.


Laser wavelength

Lasers with wavelengths from 808 nm to 1320 nm have been usedfor EVLA. Wavelength is a determinant of laser penetration andabsorption, but there is no evidence that wavelength affectsclinical outcome.

The mode of action is not precisely understood. One theory suggests that steam bubbles are formed at the laser tip causing diffuse thermal damage to the vein wall. Thus, a wavelength of 940 nm that would be maximally absorbed by haemoglobin should be optimal.24 Nevertheless, when in vitro steam bubble formation using 810, 940 and 980 nm lasers were compared, bubble volume was linearly related to laser energy and unaffected by wavelength.25

Others believe that the combined effects of vein spasm, compression by perivenous tumescent anaesthesia and ablation in the Trendelenberg position results in an ‘empty’ vein and direct thermal damage to the vein wall. This is supported by several histological studies that show intimal damage combined with discrete full thickness perforations and relatively ‘normal’ intervening vein.9,26,27

A small double-blinded RCT compared 810 nm and 980 nm lasers for GSV ablation. Occlusion rates were similar in both groups, but there was a trend towards less phlebitis, bruising and pain in the 980 nm group.28 Further, a non-randomized study comparing 940 nm and 1320 nm wavelengths reported significantly less pain, bruising and analgesia use in the longer wavelength group with no difference in GSV ablation rates.29 The authors postulatethat a longer wavelength results in fewer vein perforationsbecause of lower energy absorption by blood.

These studies provide weak evidence for fewer complicationswith a longer wavelength laser although all seemed equally effectivein achieving truncal vein ablation.


Laser dose

Lasers used for EVLA are continuous wave (CW) lasers that emit constant energy. This can be turned on and off to produce short bursts of laser energy. This should not be confused with ‘pulsed laser’ as this refers to a different and more powerful type of laser. The ‘dose’ of laser energy delivered can be expressed as joules (J)/cm vein, sometimes called linear endovenous energy density (LEED) or as fluence, which is laser energy delivered for a given surface area (J/cm2). Calculationof fluence requires estimation of the cross-sectional area ofthe vein, which varies given that the vein diameter changesdepending on the point at which it is measured or whether thepatient is standing or supine. Further, spasm following catheterizationand administration of tumescent anaesthesia affects vein diameter.

In man, a wide range of laser energies have been used, from as little as 16 J/cm (estimated)12 to 15,240 J per vein (not calculated per cm).13 Data from animal models are not particularly helpful in providing useful guidelines other than confirming more extensive transmural vein wall damage with increasing laser dose.30 In one animal model using a 1064 nm laser with a diffusing tip, a minimum laser fluence of 84 J/cm2 was recommended.31 It is unclear whether this can be extrapolated to a bare-tipped laser fibre employed clinically.31

Most clinical studies report doses in the range of 20–95 J/cm. Although there have been no prospective RCT comparing different regimens, a mathematical modelling study advised a LEED of 65 J/cm for a 3 mm vein and 100 J/cm for a 5 mm vein (in continuous mode).32 This is consistent with the findings of a number of observational studies. Thus, a non-randomized study comparing 15 W (24 [12–36] J/cm) and 30 W (63 [33–156] J/cm) power using a 940 nm laser showed that ablation rates were significantly higher in the 30 W group (90% versus 100%; P < 0.001). Recanalization at three months was associated with a lower laser dose. Conversely, analgesia use, paraesthesia and hyperpigmentation were more frequent in the higher energy group. This study also assessed fluence based on supine GSV diameter and recommended a minimum of 20 J/cm2.33

Several other studies have reported a difference in LEED between failed and successful treatments.3032,34,35 Thus, Theivacumar et al. advises a minimum LEED of 60 J/cm.37 However, the range of median doses for successes in these studies was wide (24–63 J/cm) and overlapped with the range for failures (20–47 J/cm).3438 A weakness of these reports is that the number of failures was generally small, a fact highlighted by one study with only three failures, which found no difference in LEED between successes and failures. Interestingly, the failures had significantly larger veins suggesting that comparisons of fluence (not calculated) might have been different.39

In a further study, Chang et al. used very high laser doses without tumescent anaesthesia which at least, in part, was responsible for the high complication rates (36.5% paraesthesia, 4.5% skin burns).13 Nevertheless, there does seem to be an associationbetween laser dose and both successful ablation and the riskof complications. Although the importance of fluence is stillbeing evaluated, it has the theoretical advantage of allowinga more accurate calculation of laser dose for veins of differentsize. The difficulties in defining this are described above.

Even with relatively high laser doses (95 J/cm) failures may still occur,36 which suggests that laser dose is not the onlydeterminant of success. However, the available data indicatesthat optimum occlusion rates are achieved with a minimum laserenergy of 60 J/cm. Pragmatically, withdrawal of the laser fibreat a rate of 1 cm/5 s using 14 W power allows easy and accuratedelivery of 70 J/cm.


Fibre withdrawal

The fibre may be withdrawn in a stepped or continuous fashion and the laser fired continuously or with one-second exposures. Although initial reports described ‘stepped’ withdrawal, ‘continuous’ withdrawal now appears to be favoured. This reduces treatment times and perhaps perforation and bruising. One small RCT has failed to confirm the latter.2


Manual compression during treatment

Some authors have advised manual compression of the vein duringablation. However, vein constriction following cannulation andadministration of tumescent anaesthesia would suggest that thisis unlikely to be of benefit and might increase the risk ofperforation.


Compression following treatment

While all authors advocate compression following treatment,the type (non-stretch bandage, Class I and II stockings) andduration (2–42 days) have neither been standardized nortested in randomized trials. Review of the literature indicatesthat two weeks compression is most often advised. Patients shouldbe warned about the need for compression since this may be morerestrictive than the treatment itself.


Analgesia

There appears to be wide variation in analgesia requirementfollowing EVLA. While most patients require no pain relief initially(for those that do, paracetamol is usually sufficient), a proportionof patients develop discomfort or pain in relation to the ablatedvein 4–5 days post-treatment. Although this is often termedphlebitis, it is likely to be the result of thermal injury tothe vein. If troublesome, a non-steroidal anti-inflammatorydrug (NSAID) should be prescribed until the pain resolves. Anecdotalevidence suggests that a short course of an NSAID (diclofenac50 mg t.d.s. for 3 days) commencing on the day of treatmentmay ameliorate this.


Adjunctive procedures

Since EVLA only treats junctional and truncal vein incompetence, a variety of adjunctive procedures have been described with EVLA. These include both saphenofemoral and perforator ligation. The former is unnecessary23 and the latter can justifiably beperformed either surgically or by a minimally invasive technique(laser, radiofrequency, foam sclerotherapy) at a later dateif reflux persists.

The issue of whether to perform concomitant phlebectomies or sclerotherapy (foam or liquid) in conjunction with EVLA has attracted considerable debate. The alternative of delayed sclerotherapy (or local anaesthetic phlebectomies) seems to be a more sensible approach. Protagonists of the former suggest that patients prefer to complete their treatment in a single visit. Conversely, Theivacumar et al.20 have shown that when EVLA is commenced at or below the lowest point of truncal vein reflux, only 17% of patients with GSV reflux and 11% with SSV incompetence6 have residualvaricosities requiring treatment after EVLA alone. Thus, withconcomitant therapy many patients undergo unnecessary treatmentthat may require additional resources and increase the costof the procedure. Further the patient is at risk of avoidablepigmentation following sclerotherapy or scarring after phlebectomiesfor veins that do not require treatment.


Treatment of bilateral varicose veins

There have been no RCT comparing bilateral with sequential unilateral treatment. A non-randomized comparison of unilateral and bilateral procedures found that bilateral procedures were well-tolerated with no evidence of lidocaine toxicity (doses <4.5 mg/kg).40

Since the catheter and laser fibre are the main cost of EVLA,there are obvious advantages to bilateral therapy. The potentialinfluence of provider payment for individual treatment episodeswithin the NHS will not be discussed here.


Thromboprophylaxis

Although the incidence of DVT and pulmonary embolus followingEVLA appears very low, some authors advocate up to one weekof low-molecular weight heparin following treatment to reducethe risk of thromboembolic complications. There is no good evidenceto support or refute this strategy.


The evidence for EVLA


Evidence for symptom improvement


Disease-specific health-related quality-of-life

Despite the plethora of series describing outcomes for EVLA,few have used validated outcome measures to assess changes inpatients’ symptoms. However, five studies which used the AberdeenVaricose Vein Questionnaire (AVVQ: validated disease-specificquality-of-life [QOL] measure) to assess this have shown animprovement following truncal vein ablation.

Two RCT (240 legs in total)1,2 and one non-randomized trial (132 legs)41 have shown similar improvements in AVVQ at three months following GSV EVLA or surgery, but none was powered for equivalence. In two of these studies concomitant phlebectomies were performed.1,41 Although Mekako et al.41 showed lower (better)AVVQ after EVLA, this group had lower initial scores than thesurgical patients.

Another series (68 legs) has shown a significant improvement (P < 0.001) in AVVQ scores three months after SSV EVLA,6 while a further report indicates that a significant improvement in AVVQ was maintained at one year.23

A further RCT comparing saphenofemoral ligation combined with EVLA or stripping reported similar findings using the CIVIQ measure four weeks after treatment.42 Although the study protocolincluded longer follow-up this has not been published.


Generic health-related QoL

Generic health-related QoL (which is less sensitive to change) has also been assessed following EVLA using the Short Form 36 (SF36) questionnaire. Mekako et al. in a non-randomized comparison of EVLA with phlebectomies versus surgery found a reduction in QoL in the surgical group one week following treatment (for the domains of physical role, physical functioning, social functioning and bodily pain), which was not seen in the EVLA group. By three months there was an improvement in QoL for both groups with no difference between them.41

Similar results are reported by Rasmussen et al.1 (RCT comparingEVLA with phlebectomies and surgery) using SF36. In particular,increased bodily pain was evident in the surgical group at 12days. Again QoL improved in both groups by three months.

Darwood et al. found a reduction in QoL one week following treatment,which then improved to better than baseline following EVLA orsurgery, no significant difference was seen between groups (unpublisheddata).

These studies suggest that surgery may be associated with alarger ‘dip’ in QoL following treatment, but long-termoutcomes are the same.


Evidence that EVLA abolishes varicosities and improves cosmesis

There is no validated measure to assess the cosmetic outcomeof varicose vein treatments. While some authors report the proportionof patients with residual or recurrent varicosities, it is notalways clear how, when or by whom this has been assessed. Sinceadjunctive procedures are often used with EVLA, the assessmentis not of EVLA alone but of a ‘package of care’,which varies between institutions.

Three studies have used a patient-completed visual analogue score (which may be subject to positive skew) indicating satisfaction with cosmesis after EVLA.2,41,43 One of these studies, an RCT of EVLA versus surgery,2 showed equally high levels of satisfaction(>90%) for both groups.

The AVVQ score also includes the extent of visible varicoseveins within the composite score, but does not provide specificinformation about cosmesis alone.


Evidence that EVLA is cost-effective

There is no good data regarding the cost-effectiveness of EVLA.

For health-care providers, there are initial set-up costs including purchase of the laser power source (in the region of £20,000 [22,200, US$29,500]). It might also be necessary to purchase an ultrasound machine although spare capacity on existing equipment may be available in many institutions. In addition, disposables are required for each procedure (around £275 [305, US$405]at current prices). Balanced against this is the reduced costassociated with undertaking treatment in a suitable ‘outpatient’setting rather than an operating theatre. Staffing costs arealso lower compared with surgery since fewer nurses and no anaesthetistor recovery room staff are required. Conversely, a vasculartechnologist or ultrasonographer may be required by clinicianswho do not possess the relevant ultrasound skills.

It is also likely that EVLA is associated with lower indirectcosts with little or no requirement for community nursing servicesand patients may return to work and normal activities more quicklythan after conventional surgery.

Although one RCT against surgery suggested that EVLA was more costly, the conclusion was flawed by using government re-imbursement fees rather than precise costs. In addition, operating theatre time was not measured but assumed to be equal in both groups.1A formal cost comparison of EVLA and surgery is required.


Hazards of EVLA

Lasers pose potential hazards to both user and recipient. Thediode laser used for EVLA is a class 4 laser and eye protectionis advised during use. Laser safety precautions also requirethat mirrors and windows are covered to prevent inadvertentreflection or diffusion of the laser beam and that doors arelocked to prevent entry of unprotected personnel (see Standardsto deliver service – Safety below).


Complications of EVLA


Phlebitis

Post-treatment discomfort or tenderness over the treated vein is usually termed phlebitis with symptoms maximal 5–7 days after treatment. Estimates of frequency range from 0% to 33% of patients.28 Although not proven it appears more commonwith higher laser doses perhaps, reflecting thermal injury ratherthan a true phlebitis. Routine prescription of a NSAID for threeto five days post-EVLA may lessen the associated pain and inflammation.

The literature includes one report of a severe diffuse phlegmonous thrombophlebitis following EVLA in a patient with a leg ulcer (covered during treatment). Failure to respond to intravenous antibiotics necessitated surgical drainage. The authors concluded that antibiotic prophylaxis should be considered in ulcer patients undergoing EVLA.44


Bruising

The incidence of bruising varies hugely between series (11–100%)1,44and depends on both its definition and the follow-up protocol.Some bruising seems common in the majority of patients secondaryto either administration of tumescent anaesthesia or vein wallperforation by the laser.


Cutaneous nerve injury

The highest incidence of nerve injury was reported by Chang et al.13 who used very high laser energies and no tumescentanaesthesia. Thirty-six and a half percent of patients sufferedtemporary paraesthesia and 2.4% permanent numbness. Most authorsreport a much lower incidence (1–10%) of these complicationswith the majority being temporary.

The variation in incidence may depend on the vein treated (GSV or SSV) and the site of treatment. Thus, below-knee GSV or distal SSV ablation are more likely to be associated with this complication. Although laser dose and the timing of assessment may also influence the perceived frequency of this complication, the adequacy of tumescence is perhaps the most important. Provided the latter is adequate the perivenous temperature fails to reach the level at which nerve injury is likely to occur.59


Deep vein thrombosis

The incidence of DVT following EVLA is difficult to establish. Many studies, including those with rigorous early duplex follow-up,8,33,46 report no thrombo-embolic complications. Conversely, several authors report extension of thrombus into the CFV (or popliteal vein) from the ablated truncal vein.36,46,47,49 There is no consensus on how this should be managed and advice varies from simple observation to various durations of heparin or warfarin therapy or even insertion of an IVC filter. In all cases, the thrombi resolved by three months without sequelae.5,49 There are also two reports of pulmonary emboli occurring three to four days following EVLA; there was no evidence of DVT in either patient.50,51

Risk factors for DVT are unclear although adjunctive procedures(phlebectomies), which prolong treatment and particularly theuse of general or/spinal anaesthesia (preventing immediate mobilization)may be important. The role of DVT prophylaxis, the durationof compression, the proximity of laser fibre to the deep veinsand laser dose have not been elucidated. Nevertheless, the incidenceof DVT appears low.


Hyperpigmentation

Hyperpigmentation in the line of the ablated vein occurs in up to 12% patients,10 although most authors report a much lower incidence.2,33,38,45 It tends to improve with time.


Arteriovenous fistula

There is one report of a symptomatic arteriovenous fistula developing between the SSV and a branch of the popliteal artery (treated by coil embolization) following EVLA of the short saphenous vein.52 The authors of this paper have also had a similar casein which the fistula closed spontaneously by three months. Whetherthese were secondary to laser ablation or trauma during administrationof tumescent anaesthesia is unknown.


Thread vein formation

Two papers describe single patients developing thread vein formation following EVLA.8,53 This can also occur following conventionalvaricose vein surgery, but the mechanism for their developmentis unclear.


Skin burns

Excluding the study by Chang et al.13 in which no tumescentanaesthesia was used, only nine cases of burns have been reported;two occurred when no local anaesthetic was used and two duringtreatment of tributaries. This emphasizes the importance ofcareful local anaesthetic infiltration, especially when treatinghighly superficial veins.


Technical

One broken catheter has been reported following EVLA;46 theauthors postulate that the laser fibre was pulled back insidethe catheter resulting in thermal damage. This complicationcan be avoided by ensuring that the fibre is locked to the catheterbefore withdrawal (standard manufacturer’s instructions).


Results of EVLA versus surgery


Non-randomized studies

There have been several large case series describing outcomes for EVLA. Most report GSV ablation rates of over 90%,23,45,50,54with associated improvement in symptoms as described above.


Randomized controlled trials

Five trials have compared EVLA with conventional varicose vein surgery although the package of treatment with respect to EVLA has varied. These are summarized in Table 1.



View this table:
[in this window]
[in a new window]
Table 1 Summary of outcomes for randomized trials of surgery vs. endovenous laser ablation (EVLA)

 

De Medeiros and Luccas55 assessed EVLA against GSV stripping(to the ankle) in a single-blinded (patient blind) study of20 patients with bilateral saphenofemoral incompetence. Allpatients underwent saphenofemoral ligation (SFL), ligation ofperforators and phlebectomies, with EVLA to the right leg andconventional stripping to the left under spinal or epiduralanaesthesia. Less bruising and swelling was observed followingEVLA. Although satisfaction was high after both treatments,70% patients preferred EVLA. Successful abolition of SFJ andGSV reflux was observed in 19 of 20 legs treated with EVLA.

Rasmussen et al.1 compared EVLA with surgery in an unblindedstudy of 137 patients with GSV incompetence. Both procedureswere performed under tumescent local anaesthesia with sedationand both had concomitant phlebectomies. There was a similarimprovement in QoL (Aberdeen Vein Score, SF36 and venous clinicalseverity score [VCSS] at 3 months), and return to normal activity(7 days) in both groups. Less bruising occurred after EVLA butprocedural costs were said to be higher (see above). Again abolitionof superficial venous reflux was achieved in 66 out of 68 patientsfollowing surgery (two incompletely stripped) and all patientsin the EVLA group, but three demonstrated recanalization withinsix months.

Kalteis et al.42 compared EVLA with surgery in a non-blindedstudy of 95 patients with GSV incompetence. Procedures wereperformed using general or regional anaesthesia with SFL andphlebectomies. The primary endpoints were the size of haematomaat one week (measured) and the CIVIQ (disease-specific QoL)score at four weeks. Bruising was significantly less followingEVLA while improvement in QoL was similar in both groups. SuccessfulGSV ablation was noted in all patients at 16 weeks with equivalentoutcomes for cosmesis. Interestingly, although post-treatmentpain scores were comparable in both groups during the firstweek, return to work was delayed (20 days versus 14 days) inthe EVLA group. Since EVLA was performed without tumescent anaesthesiait is tempting to suggest that this reflects greater mediumterm discomfort due to thermal soft tissue injury in these patients.

Darwood et al.2 recruited 103 patients with GSV incompetencein a three-arm study: EVLA with stepwise withdrawal (LA), EVLAwith continuous withdrawal (LA) or surgery (GA). Patients undergoingEVLA received delayed sclerotherapy (6 weeks) for persistingvaricosities. The principal outcome measures of improvementin QoL and abolition of GSV reflux (EVLA 94%; surgery 88%) weresimilar in each group, but recovery time was shorter in theEVLA groups. Patient satisfaction with the results of treatmentwas similar in all groups (>90%). Since this study was performed,the same authors have shown that a higher laser dose and commencingablation from the lowest point of reflux improve the resultsfor EVLA.

Ying et al.56 compared EVLA with surgery in 80 patients andfound less pain, blood loss and shorter hospitalization in theEVLA group (abstract only available).


Summary of RCTs

These randomized studies suggest that abolition of GSV reflux, improvements in QoL, patient satisfaction and cosmesis are similar for surgery and EVLA. Three studies also show that post-treatment discomfort was no different for either technique.2,42,55 Althoughthis may be surprising it is likely to reflect GSV and adjacentsoft tissue inflammation (‘phlebitis’) followingthe thermal injury inflicted by EVLA.

Although pain levels appear similar for surgery and EVLA return to normal activity or work is variously reported as occurring earlier after EVLA,2 at the same time following either modality1 or delayed after laser therapy.42

It is evident from these trials that there is no consensus as to the optimum treatment protocol for EVLA. Given the results reported by Rasmussen et al.1 and Darwood et al.2 it seems thatconcomitant SFL is unnecessary, thus allowing EVLA to be performedwithout general or regional anaesthesia in an outpatient oroffice setting.

The question of adjuvant treatment for the varicosities has not been answered by these studies. Only Darwood et al.2 useddelayed sclerotherapy for persisting varicose veins after EVLA.As discussed earlier provided that truncal vein ablation iscommenced at the lowest point of reflux, only a minority ofpatients require additional treatment thus supporting a policyof delayed sclerotherapy over synchronous phlebectomies forEVLA.


Long-term follow-up and the risk of recurrent varicose veins

Case series of EVLA with one to three year duplex follow-up have reported truncal vein ablation rates of 93–99%,4,23,48,54,57with most recanalizations appearing within the first year.

Critics of EVLA have suggested that the technique results in thrombotic truncal vein occlusion and that medium to long-term recurrence rates are likely to be high. However, a study which undertook serial duplex ultrasound during the first year after surgery has shown that the GSV was no longer visible in 95% of limbs one year after treatment.23 This confirms permanent irreversible ablation in the majority of patients. A further study by Thievacumar et al. has shown that neovascularization at the SFJ was evident in 1% of EVLA patients at 12 months compared with 18% in a matched control group undergoing conventional surgery.58 These data suggest that long-term recurrence ratesshould be low and potentially better than those for surgery.


Training needs

EVLA is currently performed by professionals of different specialties(surgery, dermatology, radiology) depending on local expertise.Ideally, the person performing EVLA should also assess the patientfollowing referral to confirm that treatment is indicated. Theyshould be experienced in assessing patients with venous diseaseand understand (although not necessarily perform) the benefitsand risks of different treatment modalities.

Training for EVLA includes developing ultrasound skills (unlessthe assistance of a trained ultrasonographer is sought), knowledgeabout laser safety issues and training in the EVLA technique.Further, the clinician performing EVLA should be able to undertakefollow-up, provide any further treatment that may be requiredand manage complications. Currently, there is no standard trainingprogramme for EVLA in the UK and most practitioners learn viaan informal mentoring programme.


Standards to deliver service


Safety

New guidance was issued in April of this year on the safe use of lasers by the MHRA (DB 2008(03)) and can be accessed via their website (see www.mhra.gov.uk). This covers training ofpersonnel, protective equipment and safety precautions.


Setting

EVLA does not require an operating theatre and may be performedin an outpatient setting. However, the room must meet lasersafety recommendations and the procedure should be performedusing appropriate aseptic techniques for intravenous cannulation.In addition, a tilting table is required and equipment for resuscitationshould be available.


Training

There is currently no formalized training for EVLA.


Patient pathway

Assessment for treatment: patients should be assessed clinically and with duplex ultrasound prior to treatment to determine:

  1. Is treatment indicated? (See NICE guidelines www.nice.org Referral Advice: A guide to appropriate referral from general to specialist services. National Institute for Clinical Excellence 2001. ISBN 1-84257-144-3);
  2. What is the most appropriate treatment?

Patient should complete informed consent. The procedure is usually performed as a day case under local anaesthesia. Arrangements for follow-up should be made (NICE guidance, see www.nice.org IPG052). A helplineor contact number may be useful should the patient experienceproblems.


Technique

It is difficult to prescribe a specific technique for EVLA since the literature describes considerable variation with a poor evidence base. There is little evidence to recommend a specific laser wavelength. Most current laser sources use a diode laser with a wavelength of 810–940 nm, which reflects the absorption spectrum of haemoglobin. Although a range of laser energy has been used there is reasonable evidence to suggest that 70 J/cmwill successfully ablate the GSV and SSV. There is also evidencefrom one RCT that commencing ablation at the lowest point ofreflux will lead to maximum shrinkage/disappearance of varicosetributaries. This is particularly relevant when a policy ofdelayed sclerotherapy or local anaesthetic phlebectomies isadopted for persistent varicosities. Nevertheless, a proportionof practitioners prefer to undertake concomitant phlebectomiesat the time of EVLA on the basis that this completes treatmentat a single visit.

It is strongly recommended that duplex ultrasound is used toconfirm the position of the laser fibre prior to treatment ratherthan relying on visualization of the aiming beam. In addition,despite a lack of Level 1 evidence, tumescent anaesthesia appearsimportant in preventing complications.

New developments in laser technology are currently being assessed.In particular, a 1470 nm diode laser (absorption wavelengthof water) has recently become available with the putative advantagesof being effective at much lower energy levels, not requiringtumescent anaesthesia, and causing only minimal post-EVLA discomfort.This requires further evaluation.


Clinical governance and audit

Suitable mechanisms should be in place for clinical governanceand audit. In addition to the information recorded for all invasiveprocedures/surgery, power and energy delivery should be recordedtogether with follow-up data on occlusion rates and adverseevents. Adverse incidents relating to laser use should be reportedto the MHRA.


Conflict of interest

The authors hereby declare no conflict of interests.

 

Accepted January 5, 2009
References

 

  1. Rasmussen LH, Bjoern L, Lawaetz M, Blemings A, Lawaet B, Eklof B. Randomised trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: short term results. J Vasc Surg 2007;46:308–15[Medline]
  2. Darwood R, Theivacumar N, Dellagrammaticus D, Mavor AID, Gough MJ. Randomised clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg 2008;95:294–301[Medline]
  3. Navarro L, Min RJ, Bone C. Endovenous laser: a new minimally invasive method of treatment for varicose veins: preliminary observations using an 810 nm diode laser. Dermatol Surg 2001;27:117–22[Medline]
  4. Park S, Yim S, Cha D, Kim S, Lee S. Endovenous laser treatment of the small saphenous vein with a 980-nm diode laser: early results. Dermatol Surg 2008;34:1–8[Medline]
  5. Gibson K, Ferris B, Polissar N, Neradilek B, Pepper D. Endovenous lasaer treatment of the short saphenous vein: efficacy and complications. J Vasc Surg 2007;45: 795–803[Medline]
  6. Theivacumar N, Beale R, Mavor A, Gough M. Initial experience in endovenous laser ablation (EVLA) of varicose veins due to small saphenous vein reflux. Eur J Vasc Endovasc Surg 2007;33:614–8[Medline]
  7. Proebstle TM, Gul D, Kargl A, Knop J. Endovenous laser treatment of the lesser saphenous vein with a 940-nm diode laser: early results. Dermatol Surg 2003;29:357–61[Medline]
  8. Timperman PE. Prospective evaluation of higher energy great saphenous vein endovenous laser treatment. J Vasc Interv Radiol 2005;16:791–4[Medline]
  9. Corcos L, Dini S, De A, 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;41:1018–24[Medline]
  10. Proebstle TM, Herdemann S. Early results and feasibility of incompetent perforator vein ablation by endovenous laser treatment. Dermatol Surg 2007;33:162–8[Medline]
  11. Uchino I. Endovenous laser closure of the perforating vein of the leg. Phlebology 2007;22:80–2[Abstract/Free Full Text]
  12. Park S, Yun I, Hwang J, et al. Endovenous laser ablation of varicose veins after direct percutaneous puncture: early results. Dermatol Surg 2007;33:1243–9[Medline]
  13. Chang CJ, Chua JJ. Endovenous laser photocoagulation (EVLP) for varicose veins. Lasers Surg Med 2002;31: 257–62[Medline]
  14. Davies R. Buffering the pain of local anaesthetics: a systematic review. Emerg Med 2003;15:81–8
  15. Masters J. Randomised control trial of pH buffered lignocaine with adrenaline in outpatient operations. Br J Plastic Surg 1998;51:385–7[Medline]
  16. Sultan J, Curran AJ. Effect of warming local anaesthetcis on pain of infiltration. Emerg Med J 2007;24:723–5[Free Full Text]
  17. Klein JA. Tumescent technique for regional anesthesia permits lidocaine doses of 35 mg/kg for liposuction. J Dermatol Surg Oncol 1990;16:248–63[Medline]
  18. Chong PFS, Kumar R, Kushwaha R, Sweeney A, Chaloner EJ. Technical tip: cold saline infiltration instead of local anaesthetic in endovenous laser treatment. Phlebology 2006;21:88–9[Abstract/Free Full Text]
  19. Theivacumar NS, Darwood RJ, Dellagrammmaricas D, Mavor AID, Gough MJ. The clinical significance of below-knee great saphenous vein reflux following endovenous laser ablation (EVLA) of the above-knee great saphenous vein. Phlebology 2009;24:17–20[Abstract/Free Full Text]
  20. Theivacumar NDS, Dellagrammmaricas D, Mavor AID, Gough MJ. Endovenous laser ablation: Does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial. J Vasc Surg 2008;48:173–8[Medline]
  21. Petronelli S, Prudenzano R, Mariano L, Violante F. Endovenous laser therapy of the incompetent great saphenous vein. Radiol Med Torino 2006;111:85–92[Medline]
  22. Theivacumar NS, Darwood RJ, Gough MJ. Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein (AAGSV): abolition of sapheno-femoral reflux with preservation of the great saphenous vein. Eur J Vasc Endovasc Surg, in press
  23. Theivacumar NS, Dellagrammaticas D, Beale RJ, Mavor AID, Gough MJ. Fate and clinical significance of saphenofemoral junction tributaries following endovenous laser ablation of great saphenous vein. Br J Surg 2007; 94:722–5[Medline]
  24. Proebstle TM, Lehr HA, Kargl A, et al. Endovenous treatment of the greater saphenous vein with a 940-nm diode laser: thrombotic occlusion after endoluminal thermal damage by laser-generated steam bubbles. J Vasc Surg 2002;35:729–36[Medline]
  25. Proebstle TM, Sandhofer M, Kargl A, et al. 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[Medline]
  26. Weiss RA. Comparison of endovenous radiofrequency versus 810 nm diode laser occlusion of large veins in an animal model. Dermatol Surg 2002;28:55–61
  27. Schmedt CG, Sroka R, Steckmeier S, et al. Investigation on radiofrequency and laser (980 nm) effects after endoluminal treatment of saphenous vein insufficiency in an ex vivo model. Eur J Vasc Surg 2006;32:318–25
  28. Kabnick LS. Outcome of different endovenous wavelengths for great saphenous vein ablation. J Vasc Surg 2006;43:88–93[Medline]
  29. Proebstle TM, Moehler T, Gul D, Herdemann S. Endovenous treatment of the great saphenous vein using a 1,320 nm Nd:YAG laser causes fewer side effects than using a 940 nm diode laser. Dermatol Surg 2005;31: 1678–83[Medline]
  30. Meissner O, Schmedt C-G, Hunger K, et al. Endovascular optical coherence tomography ex vivo: venous wall anatomy and tissue alteration after endovenous therapy. Eur Radiol 2007;17:2384–93[Medline]
  31. Parente E, Rosenblatt M. Endovenous laser treatment to promote venous occlusion. Lasers Surg Med 2003;33: 115–8[Medline]
  32. Mordon S, Wassmer B, Zemmouri J. Mathematical modelling of endovenous laser treatment (ELT). BioMed Eng Online 2006;5
  33. Proebstle TM, Moehler T, Herdemann S. Reduced recanalisation rates of the great saphenous vein after endovenous laser treatment with increased energy dosing: definition of a threshold for the endovenous fluence equivalent. J Vasc Surg 2006;44:834–9[Medline]
  34. Disselhoff BC, der Kinderen DJ, Moll FL. Is there recanalisation of the greater saphenous vein 2 years after endovenous laser treatment? J Endovasc Ther 2005;12:731–8[Medline]
  35. Proebstle TM, Krummenauer F, Gul D, Knop J. Non-occlusion and early re-opening of the great saphenous vein after endovenous laser is fluence dependant. Dermatol Surg 2004;30:174–8[Medline]
  36. Timperman PE, Sichlau M, Ryu R. Greater energy delivery improves treatment success of endovenous laser treatment of incompetent saphenous veins. J Vasc Interv Radiol 2004;15:1061–3[Medline]
  37. Theivacumar N, Beale R, Mavor A, Gough M. Factors influencing the effectiveness of endovenous laser treatment (EVLT) for varicose veins due to sapheno-femoral (SF) and long saphenous (LSV) reflux. Eur J Vasc Endovasc Surg 2008;35:119–23[Medline]
  38. Vuylsteke M, Liekens K, Moons P, Mordon S. Endovenous laser treatment of saphenous vein reflux: how much energy do we need to prevent recanalisations. Vasc Endovasc Surg 2008;42:141–9
  39. Kim H, Nwankwo I, Hong K, McElgunn P. Lower energy endovenous laser ablation of the great saphenous vein with 980 nm diode laser in continuous mode. Cardiovasc Interv Radiol 2006;29:64–9[Medline]
  40. d’Othee B, Faintuch S, Schirmang T, Lang E. Endovenous laser ablation of the saphenous veins: bilateral versus unilateral single-session procedures. J Vasc Interv Radiol 2008;19:211–5[Medline]
  41. Mekako A, Hatfield J, Bryce J, Lee D, McCollum P, Chetter IC. A non-randomised controlled trial of endovenous laser therapy and surgery in the treatment of varicose veins. Ann Vasc Surg 2006;20:451–7[Medline]
  42. Kalteis M, Berger I, Messie-Werndl S, et al. High ligation combined with stripping and endovenous laser ablation of the great saphenous vein: early results of a randomised controlled study. J Vasc Surg 2008;47:822–9[Medline]
  43. Sharif MA, Soong CV, Lau LL, Corvan R, Lee B, Hannon RJ. Endovenous laser treatment for long saphenous vein incompetence. Br J Surg 2006;93:831–5[Medline]
  44. Dunst K, Huemer G, Wayand W, Shamiyeh A. Diffuse phlegmonous phlebitis after endovenous laser treatment of the greater saphenous vein. J Vasc Surg 2006;43:1055–8
  45. Agus GB, Mancini S, Magi G. The first 1000 cases of Italian Endovenous-laser Working Group (IEWG). Rationale, and long-term outcomes for the 1999–2003 period. Int Angiol 2006;25:209–15[Medline]
  46. Yilmaz S, Ceken K, Alparslan A, Sindel T, Luleci E. Endovenous laser ablation for saphenous vein insufficiency: immediate and short-term results of our first 60 procedures. Diagn Interv Radiol 2007;13:155–63
  47. Viarengo L, Poterio-Filho J, Poterio G, Menezes F, Meirelles G. Endovenous laser treatment for varicose veins in patients with active ulcers: measurement of intravenous and perivenous temperatures during the procedure. Dermatol Surg 2007;33:1234–42[Medline]
  48. Yang C-H, Chou H-S, Lo Y-F. Incompetent great saphenous veins treated with endovenous 1,320 nm laser: results for 71 legs and morphologic development study. Dermatol Surg 2006;32:1453–7[Medline]
  49. Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenouse vein: analysis of early efficacy and complications. J Vasc Surg 2005;42:488–93[Medline]
  50. Ravi R, Rodriguez LJ, Trayler EA, Barrett DA, Ramaiah V, Diethrich E. Endovenous ablation of incompetent saphenous veins: a large single-center experience. J Endovasc Ther 2006;13:244–8[Medline]
  51. Myers K, Fris R, Jolley D. Treatment of varicose veins by endovenous laser therapy: assessment of results by ultrasound surveillance. Med J Aust 2006;185:199–202[Medline]
  52. Timperman PE. Arteriovenous fistula after endovenous laser treatment of the short saphenous vein. J Vasc Interv Radiol 2004;15:625–7[Medline]
  53. Sadick N, Wasser S. Combined endovascular laser with ambulatory phlebectomy for the treatment of superficial venous incompetence: a two-year perspective. J Cosmetic Laser Ther 2004;6:44–9
  54. Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reflux: long-term results. J Vasc Interv Radiol 2003;14:991–6[Medline]
  55. de Medeiros C, Luccas G. Comparison of endovenous treatment with an 810 nm laser versus conventional stripping of the great saphenous vein in patients with primary varicose veins. Dermatol Surg 2005;31:1685–94[Medline]
  56. Ying L, Sheng Y, Ling H, Lian Y, Hui Y, Ming W. A random, comparative study on endovenous laser therapy and saphenous veins stripping for the treatment of great saphenous vein incompetence. Zhonghua-Yi-Xue-Za-Zhi 2007;87:3043–6
  57. Kavuturu S, Girishkumar H, Ehrlich F. Endovenous laser ablation of saphenous vein is an effective treatment modality for lower extremity varicose veins. Am Surg 2006;72:672–5[Medline]
  58. Theivacumar NS, Darwood RJ, Mavor AID, Gough MJ. Recurrence and neovascularisation two years after varicose vein treatment: a comparison of surgery and endovenous laser ablation (EVLA). Br J Surg 2008;95:1–12[Medline]
  59. Beale RJ, Mavor AID, Gough MJ. Heat dissipation during endovenous laser treatment (EVLT) of varicose veins (VVs) – is there a risk of nerve injury? Phlebology 2006;21:32–5[Abstract/Free Full Text]

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What’s this?






This article has been cited by other articles:



D Berridge, T Lees, and J J Earnshaw
The VEnous INtervention (VEIN) Project
Phlebology,

April 1, 2009;
24(suppl_1):
1 – 2.

[Full Text]
[PDF]


 

This Article

Abstract

Full Text (PDF)


Alert me when this article is cited

Alert me if a correction is posted
Services

Email this article to a friend

Similar articles in this journal


Similar articles in PubMed

Alert me to new issues of the journal

Download to citation manager

Citing Articles

Citing Articles via HighWire

Citing Articles via Web of Science (1)

Citing Articles via Google Scholar
Google Scholar

Articles by Darwood, R J

Articles by Gough, M J
Search for Related Content
PubMed

PubMed Citation
Social Bookmarking

What’s this?