Current clinical evidence on endovenous laser ablation (EVLA) from randomised trials

Summary

Background Endovenous laser ablation (EVLA) is globally counted among the most frequently administered methods to treat saphenous vein incompetence. Technical development proceeded in three particular steps: EVLA #1 – Diode lasers linearly emitting wavelengths from 810 to 980 nm through optical bare fibres; EVLA #2 – Diode or Nd:YAG lasers emitting wavelengths from 1064 to 1500 nm; EVLA #3 – Modified optical fibres warranting an optimised emission geometry by centralisation of the fibre tip (Tulip-fibre, Jacket-tip) or radial emission of the laser beam. Due to the number of different EVLA techniques their value compared with standard surgery (high ligation and stripping, HLS) and other endovascular approaches has to be questioned.

Methods Selective literature analysis based on a systematic PubMed search focussed on randomised controlled trials (RCT) comparing EVLA with HLS and other thermal or nonthermal ablation techniques – radiofrequency ablation (RFA), ultrasound guided foam sclerotherapy (UGFS), endothermal steam ablation (EStA).

Results The search terms “endovenous”, “laser”, “varicose vein” resulted in 509 publications, hereof 57 RCTs, hereof 24 randomised studies comparing EVLA with other treatment approaches: 15 studies comprise comparisons with standard surgery and further 9 studies with other endovenous techniques. 6 RCTs contain long-term followup data on EVLA #1 vs. HLS suggesting superiority of HLS in terms of same site clinical and duplex detected recurrence from the groin. 15 RCTs are reporting short-term results clearly demonstrating inferiority of EVLA #1 against EVLA #2, EVLA #3, and RFA with respect to postoperative complaints and patients’ quality of life.

Conclusions The first generation endovenous laser systems are disadvantageous or even harmful as compared with more advanced EVLA techniques and RFA in terms of patients’ complaints and side effects. Furthermore, evidence is rising that EVLA #1 is inferior to standard surgery regarding long-term treatment efficacy. Therefore, the application of EVLA #1 in the treatment of saphenous vein incompetence cannot be recommended any longer. In view of the more recently published RCTs reporting long-term superiority of standard surgery, HLS should still be implemented as control group in studies investigating endovenous treatment approaches.

Keywords

Endovenous laser ablation - evidence - randomized controlled trial

• References

• 1 Almeida JI, Kaufman J, Göckeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol 2009; 20 (06) 752-759.
• 2 Brittenden J, Cotton SC, Elders A, Ramsay CR, Norrie J, Burr J, Campbell B, Bachoo P, Chetter I, Gough M, Earnshaw J, Lees T, Scott J, Baker SA, Francis J, Tassie E, Scotland G, Wileman S, Campbell MK. A randomized trial comparing treatments for varicose veins. N Engl J Med 2014; 371 (13) 1218-1227.
• 3 Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg 2011; 98 (08) 1117-1123.
• 4 Christenson JT, Gueddi S, Gemayel G, Bounameaux H. Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up. J Vasc Surg 2010; 52: 1234-1241.
• 5 Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg 2008; 95: 294-301.
• 6 De Maeseneer MG, Vandenbroeck CP, Hendriks JM, Lauwers PR, van Schil PE. Accuracy of duplex evaluation one year after varicose vein surgery to predict recurrence at the sapheno-femoral junction after five years. Eur J Vasc Endovasc Surg 2005; 29: 308-312.
• 7 De Maeseneer MG, Pichot O, Cavezzi A, Earnshaw J, van Rij A, Lurie F, Smith PC. Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins – UIP consensus document. Eur J Vasc Endovasc Surg 2011; 42: 89-102.
• 8 Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL. Five-year results of a randomized clinical trial comparing endovenous laser ablation with cryostripping for great saphenous varicose veins. Br J Surg 2011; 98 (08) 1107-1111.
• 9 Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL. Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction. Eur J Vasc Endovasc Surg 2011; 41 (05) 685-690.
• 10 Doganci S, Demirkilic U. Comparison of 980 nm laser and bare-tip fibre with 1470 nm laser and radial fibre in the treatment of great saphenous vein varicosities: a prospective randomised clinical trial. Eur J Vasc Endovasc Surg 2010; 40 (02) 254-259.
• 11 Eberhardt RT, Reffetto JD. Chronic venous insufficiency. Circulation 2005; 111: 2398-2409.
• 12 Evans CJ, Fowkes FGR, Ruckley CV. et al. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health 1999; 53: 149-153.
• 13 Flessenkämper I, Hartmann M, Hartmann K, Stenger D, Roll S. Endovenous laser ablation with and without high ligation compared to high ligation and stripping for treatment of great saphenous varicose veins: Results of a multicentre randomised controlled trial with up to 6 years follow-up. Phlebology 2016; 31 (01) 23-33.
• 14 Gauw SA, Lawson JA, van Vlijmen-van Keulen CJ, Pronk P, Gaastra MT, Mooij MC. Five-year followup of a randomized, controlled trial comparing saphenofemoral ligation and stripping of the great saphenous vein with endovenous laser ablation (980 nm) using local tumescent anesthesia. J Vasc Surg 2016; 63 (02) 420-428.
• 15 Gloviczki P, Comerota AJ, Dalsing MC. et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg 2011; 53 (Suppl. 05) 2S-48S.
• 16 Goode SD, Chowdhury A, Crockett M, Beech A, Simpson R, Richards T, Braithwaite BD. Laser and radiofrequency ablation study (LARA study): A randomized study comparing radiofrequency ablation an endovenous laser ablation (810 nm). Eur J Vasc Endovasc Surg 2010; 40: 246-253.
• 17 Lattimer CR, Kalodiki E, Azzam M, Makris GC, Somiayajulu S, Geroulakos G. Interim results on abolishing reflux alongside a randomized clinical trial on laser ablation with phlebectomies versus foam sclerotherapy. Int Angiol 2013; 32 (04) 394-403.
• 18 Lin Y, Ye CS, Huang XL, Ye JL, Yin HH, Wang SM. A random, comparative study on endovenous laser therapy and saphenous veins stripping fort he treatment of great saphenous vein incompetence. Zhongua Yi Xue Za Zhi 2007; 87 (43) 3043-3046.
• 19 Mozafar M, Atqiaee K, Haghighatkhah H, Taheri MS, Tabatabaey A, Lotfollahzadeh S. Endovenous laser ablation of the great saphenous vein versus high ligation: long-term results. Lasers Med Sci 2014; 29 (02) 765-771.
• 20 Nandhra S, El-sheikha J, Carradice D, Wallace T, Souroullas P, Samuel N, Smith G, Chetter IC. A randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. J Vasc Surg 2015; 61 (03) 741-746.
• 21 Nesbitt C, Bedenis R, Bhattacharya V. et al. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus conventional surgery for great saphenous vein varices. Cochrane Database Syst Rev 2014; 07: CD005624.
• 22 Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, Loftus IM. A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins. Ann Surg 2011; 254 (06) 876-881.
• 23 Pröbstle 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.
• 24 Rabe E, Pannier-Fischer F, Bromen K. et al. Bonn Vein Study by the German Society of Phlebology. Epidemiological study to investigate the prevalence and severity of chronic venous disorders in the urban and rural residential populations. Phlebologie 2003; 32: 1-14.
• 25 Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg 2011; 98 (08) 1079-1087.
• 26 Rasmussen L, Lawaetz M, Bjoern L, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation and stripping of the great saphenous vein with clinical and duplex outcome after 5 years. J Vasc Surg 2013; 58 (02) 421-426.
• 27 Rass K, Frings N, Glowacki P, Gräber S, Tilgen W, Vogt T. Same site recurrence is more frequent after endovenous laser ablation compared with high ligation and stripping of the great saphenous vein – 5-year results of a randomized clinical trial (RELACS study). Eur J Vasc Endovasc Surg 2015; 50: 648-656.
• 28 Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH. Randomized clinical trial of VNUS® ClosureFast™ radiofrequency ablation versus laser for varicose veins. Br J Surg 2010; 97: 810-818.
• 29 Spreafico G, Piccioli A, Bernardi E, Giraldi E, Pavei P, Borgoni R, Nosadini A, Baccaglini U. Endovenous laser ablation of great and small saphenous vein incompetence with a 1470-nm laser and radial fiber. J Vasc Surg Venous Lymphat Disord 2014; 02 (04) 403-410.
• 30 Theivacumar NS, Darwood R, Gough MJ. Neovascularisation and recurrence 2 years after varicose vein treatment for sapheno-femoral and great saphenous vein reflux: a comparison of surgery and endovenous laser ablation. Eur J Vasc Endovasc Surg 2009; 38: 203-237.
• 31 Van den Bos RR, Malskat WS, De Maeseneer MG, de Roos KP, Groeneweg DA, Kockaert MA, Neumann HA, Nijsten T. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. Br J Surg 2014; 101 (09) 1077-1083.
• 32 Van der Velden SK, Biemans AA, De Maeseneer MG, Kockaert MA, Cuypers PW, Hollestein LM, Neumann HA, Nijsten T, van den Bos RR. Fiveyear results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. Br J Surg 2015; 102 (10) 1184-1194.
• 33 Van der Velden SK, Pichot O, van den Bos RR. et al. Management strategies for patients with varicose veins (C2-C6): Results of a worldwide survey. Eur J Vasc Endovasc Surg 2015; 49: 213-20.
• 34 Van der Velden SK, Lawaetz M, De Maeseneer MGR. et al. on behalf of the Members of the Predictors of Endovenous Thermal Ablation Group. Predictors for recanalization of the great saphenous vein in randomized controlled trials one year after endovenous thermal ablation. Eur J Vasc Endovasc Surg. 2016 Mar 16. doi: 10.1016/j.ejvs.2016.01.021. [Epub ahead of print].
• 35 Vuylsteke M, De Bo TH, Dompe G. et al. Endovenous laser treatment: is there a clinical difference between using a 1500 nm and a 980 nm diode laser? A multicenter randomised clinical trial. Int Angiol 2011; Aug; 30 (04) 327-334.
• 36 Vuylsteke ME, Thomis S, Mahieu P, Mordon S, Fourneau I. Endovenous laser ablation of the great saphenous vein using a bare fibre versus a tulip fibre: a randomised clinical trial. Eur J Vasc Endovasc Surg 2012; 44 (06) 587-592.
• 37 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.
• 38 Wittens C, Davies AH, Bækgaard N. et al. Editor’s Choice - Management of Chronic Venous Disease: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 2015; 49: 678-737.