Catheter-based treatments for varicose veins: evidence and practice.
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1 imeet May 2018, Nice France Catheter-based treatments for varicose veins: evidence and practice. Marc Vuylsteke MD PhD Vascular Surgeon Sint-Andriesziekenhuis Tielt Belgium
2 Venous Disease C0: 38.5% C1: 21.4% C2: 15.35% C3: 15.8% CVD: 61.6% C4: 7.37% CVI: 24.8% C5: 1.23% C6: 0.44% Vuylsteke ME, Colman R, Thomis S, Guillaume G, Van Quickenborne D, Staelens I. An epidiomological survey among general practitioner attendees in different geographical regions on the globe: the final results of the vein consult program. Angiology 2018, ahead of publication
3 Varicose veins Truncal veins GSV AASV SSV Giacommuni Non-truncal veins Tributaries perforating veins Deep venous system Pelvic veins
4 Catheter based treatments Endovenous thermal ablation EVLA RFA Steam MOCA (mechanochemical ablation) UGFS Glue Embolisation techniques Venous stenting
5 Great Saphenous vein incompetence Male, 48y C2 heavy legs, sensation of swelling and night cramps
6 Great Saphenous vein incompetence
7 Great saphenous vein incompetence EVTA? laser RFA Steam? Foam? MOCA? Glue?
8 EVLA - Wavelengths Different wavelengths: 810,940,980,1320,1470,1500nm Absorption coefficient and Scattering coefficient Serge Mordon INSERM
9 Wavelengths Extinction coefficients (red) related to wavelength and different biological tissues. µa (mm -1 ) : absorption coefficient in tissue µ s (mm -1 ) : reduced scattering coefficient µeff: optical extinction Serge Mordon INSERM M.Vuylsteke, S Mordon, Endovenous laser ablation. Review of the mechanisms of action. Ann Vasc Surg 2012;26:
10 Evidence p-value 940nm 1470nm n LEED 40J/cm 40J/cm fibre Tulip Tulip p-value 980nm 1500nm n LEED 80,J/cm 60J/cm fibre bare bare Ecchymosis score 0 0 Ecchymosis score 0,09 1,2 SD:2,3 0,69 SD:0,8 HRQoL 12W (AVVQ) ( ) 4.58(1.72 vs 8.5) pain VAS 1W 4 6 (3-8) 3(2-7) intake of analgetics: days 0,03 2,89 SD:1,3 1,82 SD:1,2 DVT 0 0 satisfaction rate (VAS) 0,062 6(3-8) 9 (8-10 Induration 1 week <0,01 1,17 SD:2,45 0,28 SD:1,2 Induration 1 month intake of analgetics: days Quality of life (20-100) <0,01 0,48 SD:1,2 0,03 SD:O,3 0,03 2,89 SD:1,3 1,82 SD:1,2 0,018 37,41 SD:12,6 33,23 SD:9,62 satisfaction rate 0,66 0,99 SD:0,1 0,98 SD:0,15 occlusion rate 12 months /66 (91%) 62/66 (94%) occlusion rate 6 months 0,34 95,5% (84/88) 93,1% (81/87) Malskat W, Gang J, De Maeseneer M et al. Randomized clinical trial of 940- versus 1470nl endovenous laser ablation for great saphenous vein incompetence. Br J Surg 2016;103: Vuylsteke ME, De Bo Th, Dompe G, Di Crisci D, Abbad CM, Mordon S. Endovenous laser treatment: is there a clinical difference between using a 1500nm and a 980nm diode laser? A multicentre randomised clinical trial. International Angiology. 2011; 30(4):
11 Endovenous thermal ablation EVLA different fibres Bare fibre Tulip fibre Radial fibre Never-touch Ball-tip fibre
12 Bare fibre
13 New fibre
14 Endovenous Thermal ablation Higher wavelengths: equal occlusion rates (97-100%), less postoperative pain. New fibre design: equal occlusion rates, fewer side -effects. Yamamoto T, Masahiro S. Influence of fibre and wavelengths on the mechanism of action of endovenous laser ablation. J Vasc Surg venous and Lymphatic disorders. 2014;2: Doganci S, Demirkilic U. Comparison of 980nm laser and bare-tip fibre with 1470nm laser and radial fibre in the treatment go great saphenous vein varicosities: a prospective randomized clinical trial. Eur J Vasc Endovasc Surg 2010;40: 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:
15 Tulip trial 368 patients with GSV insufficiency 215 fulfilled incusion and exclusion criteria 174 Randomised Excluded: 153 Bilateral Incompetent SSV or ASV Diameter >15 mm Deep venous insufficiency Hypo/hypercoagulopathy Occlusive arterial disease Pregnancy <18 years old 41 refused randomisation 87 Bare fiber 87 Tulip fiber Analysed with a follow-up of 1 month(n=87) Analysed with a follow-up of 6 months(n=83) Analysed with a follow-up of 1 year (n=82) Analysed with a follow-up of 1 month (n=87) Analysed with a follow-up of 6 months (n=85) Analysed with a follow-up of 1 year (n=85)
16 Results BARE TULIP Factor 25% Median 75% 25% Median 75% Sig Echymosis Score Painscore d Mann Withney U-test Painscore 2 weeks analgesics, days analgesics, total number QOL (20-100) CIVIQ ,023 Satisfaction Occlusion rate one month 85/87 (97.7%) 83/86 (96.5%) 0,974 Occlusion rate six months 82/85 (96.5%) Occlusion rate one year 82/85 (96.5%) 76/83 (91.6%) 81/82 (98.7%) 0,179 0,745 non-inferiority Newcombe s test
17 Radiofrequency Radiofrequency Closure Plus Closure Fast RFA/EVLA Similar occlusion rates. RFA: less postoperative bruising and pain (EVLA: bare fibre-lower wavelengths).
18 Evidence Nordon IM, Hinchliffe RJ, Brar R, Moxey P, Black SA, Thompson MM, et al. 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: Lawaetz M, Serup J, Lawaetz B, BjoernL, Eklof B, Rasmussen L. Comparison of endovenous ablation techniques and surgical stripping of the great saphenous varicose veins. Extended -years follow-up of a RCT. Int Angiol 2017;36: Rasmussen LH, Lawaetz M, Bjoern L et al. Randomized clinical trial comparing endogenous laser ablation, radio frequency ablation, foam sclerotherapy, and surgical stripping for great saphenous veins.br J Surg 2011;98: Goode SD, Chowdhury A, Crockett M et al. Laser and radiofrequency ablation study (LARA study): a randomized study comparing radiofrequency ablation and endovenous laser ablation 810nm. Eur J Vasc Endovasc Surg 2010;40: Gale SS, Lee JN, Walsh ME et al. A randomized controlled trial of endovenous thermal ablation using the 810nm wavelength laser and the Closure Plus radio frequency ablation methods for superficial venous insufficiency of the great saphenous vein. J Vasc Surg 2010;52: Shepard AC, Gohel MS, Brown LC et al. Randomized clinical trial of VNUS ClosureFast radio frequency ablation versus laser for varicose veins. Br J Surg 2010;97: Almeida JL, Kaufman J, Gockeritz et al. Radiofrequency endovenous ClosureFast versus laser ablation for the treatment of great saphneous reflux: a multicenter, single blinded randomized study (RECOVERY study). J Vasc Inter Radiol 2009; Lawson J, Gauw S, van Vlijmen CJ et al. Prospective comparative cohort study evaluating incompetent great saphenous vein closure using radio frequency powered segmental ablation or 1470nm endovenous laser ablation with radial-tip fibre. J Vasc Surg Venous and lymphat dis 2018;6:32-40.
19 Varico 2 study pain d1-10 pain medication bruising paresthesia DVT HRQoL (AVVQ) Lawson J, Gauw S, van Vlijmen CJ et al. Prospective comparative cohort study evaluating incompetent great saphenous vein closure using radio frequency powered segmental
20 Mechanochemical ablation No tumescence No perivenous tissue destruction MOCA is safe and effective in the treatment of SV reflux. One-year anatomic success rate was 94%
21 MOCA (Clarivein) No randomized trials available One retrospective observational trial: less pain compared to RFA Elias S, Lam YL, Wittens C. Mechanochemical ablation: status and results. Phlebology 2013;28 S: van Eekeren R, Boersma D, Elias S et al. Endovenous Mechanochemical Ablation of Great Saphenous Vein Incompetence Using the Clarivein Device: A safety study. J Endovasc Ther 2011;18: Boersma D, van Eekeren R, Werson D et al. Mechanochemical Endovenous Ablation of Small Saphenous Vein Insufficiency Using the Clarivein Device: one-year results of a prospective series. Eur J Vasc Endovasc Surg 2013;45: Vos CG, Unlü CU, Bosma J et al. A systematic review and meta-analysis of two novel techniques of non thermal endivenous ablateon of the great saphenous vein. J Vasc Surg; Venous and Lymphatic Disorders 2017;5: van Eekeren R, Boersma D, Konijn V et al. Postoperative pain and early quality of life after radiofrequency ablation and mechachemical endivenous ablation of incompetent great saphenous vein. J Vasc Surg 2013;57: Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology 2012;27:67-72.
22 Cyano acrylate glue No tumescence No stockings Glue: non-inferiority compared to RFA $$ Morrison N, Gibson K, McEnroe S et al. Randomized trial comparingcyanoacrylate embolisation and radio frequency ablation for incompetent great saphenous veins J Vasc Surg 2015;61: Almeida JI, Min RJ, Raabe R, McLean DJ, Madsen M. Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results. Vasc Endovascular Surg 2011;45: Lam YL, De Maeseneer M, Lawson J, De Borst GJ, Boersma D. Expert review on the VenaSeal(R) system for endovenous cyano-acrylate adhesive ablation of incompetent saphenous trunks in patients with varicose veins. Expert Rev Med Devices 2017;14: Proebstle TM, Alm J, Dimitri S, et al. Twelve-Month Follow-up of the European Multicenter Study on Cyanoacrylate Embolization of Incompetent Great Saphenous Veins. J Vasc Surg Venous Lymphat Disord 2014;2:105-6.
23 Endovenous Thermal ablation Recommendation 43 Class level For the treatment of great saphenous vein reflux in patients with symptoms and signs of chronic venous disease, EVTA techniques are recommended in preference to surgery I A Wittens C, Davies A, Wittens, A. Davies, Bækgaard N, Broholm R, Cavezzi A, Chastanet S,de Wolf M,Eggen C, Giannoukas A, Gohel M, Kakkos S, Lawson J, Noppeney T, Onida S, Pittaluga P, Thomis S, Toonder I, Vuylsteke M. Management of Chronic venous disease. Clinical practice guidelines of the European Society for vascular Surgery. Eur J Vasc Surg 2015,49:
24 Anterior accessory saphenous vein incompetence Female pt age 42y swelling, pain, restless legs, heaviness
25 Anterior accessory saphenous vein incompetence
26 Anterior accessory saphenous vein Endovenous ablation of truncal vein Phlebectomy of side branches (simultaneously or not?) Perforator? When performing endovenous thermal ablation of a refluxing saphenous trunk; adding concomitant phlebotomies should be considered. Class 2a, Level B Chaar CI, Hirsch SA, Cwenar MT et al. Expanding the role of endovenous laser therapy: results in larger diameter saphenous, small saphenous and anterior accessory saphenous vein. Ann Vasc Surg 2011;25: Mekako A, Hattfield J, Bryce J et al. Combined endovenous laser therapy and ambulatory phlebectomy: refinement of the technique. Eur J Vasc Endovasc Surg 2006, 32, Harlander M, Jimenez J, Lawrence P et al. Endovenous ablation with concomitant phlebectomy is a safe and effective method of treatment for symptomatic patients with axial reflux and large incompetent tributaries. J Vasc Surg 2013; 58:
27 Perforating veins?
28 Concomitant ablation of perforating veins? More than half of the incompetent perforating veins become competent after truncal ablation. Perforating surgery results in an objective reduction in the number of detectible perforating veins. However this is not clinical significant for the patients. Stuart WP, Adam DJ, Allan PL, Ruckley CV, Bradbury AW: Saphenous surgery does not correct perforator incompetence in the presence of deep venous reflux. J Vasc Surg 28: , Mendes RR, Marston WA, Farber MA, Keagy BA: Treatment of superficial and perforator venous incompetence without deep venous insufficiency: Is routine perforator ligation necessary? J Vasc Surg 38: , Al-Mulhim AS, El-Hoseiny H, Al-Mulhim FM, et al: Surgical correction of main stem reflux in the superficial venous system: Does it improve the blood flow of incompetent perforating veins? World J Surg 27:
29 Conclusions Several options are available in the treatment of varicose veins. No real superiority between the different endovenous techniques.
30 That which is new at this time will one day be ancient; as what is ancient was once new. It is not the length of time which gives value to things, it is their own excellency. Auguste Belloste,
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Table XI. Operative procedure EVLA with different wavelengths HL+ EVLA EVLA without HL EVLA GSV ablation AK GSV ablation AK+BK Reference Abstracts corresponding to references can be found using the listing
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