Which place for liquid sclerotherapy? Eberhard Rabe Department of Dermatology University of Bonn Germany

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1 Which place for liquid sclerotherapy? Eberhard Rabe Department of Dermatology University of Bonn Germany

2 Liquid Foam or

3 GSV, foam / liquid sclerosant n diameter[mm] Follow up effectivity Hamel Desnos 2003 Pol 3% Foam Pol 3% liquid months 82 % months 25 % Rabe 2007 Pol 3% Foam Pol 3% liquid 54 7,5 3 months 69 % 52 7,7 3 months 27 % Ouvry 2008 Pol 3% Foam Pol 3% liquid months 53 % months 12 %

4 GSV, up to 3 months follow-up ø Reflux Hamel Desnos 2003 Hamel Desnos 2007 Wright 2006 Rabe 2007 Foam n Diameter [mm] Follow up Effektivity Pol 3% weeks 84 % Pol 3% 74 6,1 3 weeks 96 % Pol 1% 74 6,1 3 weeks 88 % Pol 1% 428 7,1 3 months 84 % Pol 3% 54 7,9 3 months 69 %

5 GSV, up to 2 years follow-up ø Reflux Foam N = diameter [mm] Follow-up Effektivity Yamaki 2004 Pol 2 % 37? 1 year 67,6 % Hamel-Desnos 2003 Hamel Desnos 2007 Pol 3% year 80 % Pol 1% 74 6,1 2 years 68 % Pol 3% 74 6,1 2 years 68 % Wright 2006 Pol 1% 428 7,1 1 year 78,9 % Ceulen 2007 Pol 1% 40 5,4 1 year 69,5 % Pol 3% 40 6,4 1 year 80,10 % Ouvry 2008 Pol 3% years 53 %

6 Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up L. Rasmussen et al, JVS:VL 2013;1: Methods: 500 consecutive patients (580 legs) with GSV reflux EVLA (980 and 1470 nm, bare fibre), RFA, ultrasound-guided foam sclerotherapy or stripping using tumescent local anaesthesia with light sedation Miniphlebectomies were also performed Follow-up 3 days, 1 month, 1 year and 3 years Results: Recanalisation: RF 8 (7%), EVLA 8 (6.8%), UGFS 31 (26.4%) and K+S 8 (6.5%) (p<0.01) Recurrent varicose veins: 17 (14.9%), 24 (20%), 20 (19.1%) and 22 (20.2%) (p=ns) Retreatment:12 (11.1%, 14 (12.5%), 37 (31.6%) and 18 (15.5) (p<0.01) Disease-specific quality-of-life and Short Form 36 (SF-36) improved in all groups significantly with no difference between the gropups

7 Shadid N et al. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg 2012 GSV varicose veins 230 UGFS vs. 200 HL&Stripping 2-year probability of clinical recurrence: 11 3 per cent (24 of 213) UGFS 9 0 per cent (16 of 177) HL+S (P = 0 407). 2 years, reflux irrespective of venous symptoms UGFS group 35 0 % HL+S 21 0 % (P = 0 003) No difference in symptoms Hospital costs / patient over 2 year 774(344) UGFS 1824(141) HL+S

8 Conclusion In varicose (saphenous) veins foam is significantly better but has still high recurrence rates in the long term follow up Mechanochemical ablation (MOCA) with liquid polidocanol in a rotating mechanical device may have advantages for bigger diameter GSV but comparative studies with foam are missing

9 From Wienert, Phlebologie Telangiectases

10 Rabe E et al: Sclerotherapy of telangiectases and reticular veins: a double-blind, randomized, comparative clinical trial of polidocanol, sodium tetradecyl sulphate and isotonic saline (EASI study). Phlebology 2010;25: randomized patients 160 with telangiectases 0.5% POL, 1% STS or placebo 156 with reticular veins 1% POL, 1% STS or placebo Predefined treatment area (10 10 cm) Up to 3 injection sessions Follow-up 12 and 26

11 V1: baseline Digital Images Example 2 V4: 12 weeks V5: 26 weeks

12 The 5-grade Scale The treatment areas were rated by the investigator and two medical experts (Mark Malouf, Australia, Claudine Hamel-Desnos, France) Worst Best 1 worse than before (more veins in the treatment area are observable than before or veins are more dilated or looked worse than before) 2 same as before (no improvement but also no worsening observable) 3 moderate improvement (improvement observable but not yet satisfactory, needs to be treated again) 4 good improvement (satisfactory treatment success, only slight improvement still possible) 5 complete treatment success (no improvement necessary)

13 Improvement of Veins 5 4 Mean score (5-grade scale) at 12 weeks 4,6 4,4 4,4 4,6 POL 0.5% S POL 1% R STS 1% S 5 3 STS 1% R Pla S 1 2 2,1 2,3 POL 0.5% S POL 1% R STS 1% S STS 1% R Pla S Pla R Pla R Polidocanol improves veins significantly better than Placebo Dr.Murena-Schmidt

14 Treatment Success Rates Derived from the assessment of the 5-grade-scale: 2 categories YES 4,5 NO 1,2,3 success failure

15 Treatment Success Rates % treatment success at 12 weeks ,6 97,4 88,2 96,3 POL 0.5% S POL 1% R STS 1% S STS 1% R 40 Pla S Pla R ,7 11,5 POL 0.5% S POL 1% R STS 1% S STS 1% R Pla S Pla R Polidocanol success rates at 12 (and 26) wks significantly higher Dr.Murena-Schmidt as compared to placebo

16 Reticuar varicose veins before and after 12 weeks weeks 0.5% liquid polidocanol

17 Telangiectases before and after 12 weeks 0.5% liquid polidocanol

18 Telangiectasies et varices reticulaires. Traitment par la mousse d`aetoxisclerol J.P.Benigni, S.Sadoun, Phlebologie, 1999:52; Telangiectases prospektive, randomised N = 20 0,25% Polidocanol liquid versus foam Follow-up 75 days Results better with foam but more microthrombi and inflammation

19 Sclerotherapy : a study comparing polidocanol foam and liquid form Uncu, H Phlebology : patients with teleangiectasies and small varicose veins <4mm were included Conclusion: compression sclerotherapy is an effective and useful method for treating small varicose veins and teleangiectasies Foam sclerotherapy Liquid sclerotherapy 84% dissappearance 72% dissappearance but no satistical significance!! ( p= 0,148) No significant difference of side effects between the groups

20 Side effects of sclerotherapy European Guidelines Type of adverse event Severe complications* Anaphylaxis Large tissue necrosis Stroke and TIA Distal DVT (mostly muscular) Proximal DVT Pulmonary Embolism Motor nerve injury Frequency With liquid Isolated cases Isolated cases Isolated cases Rare 0.01 % - < 0.1 % Isolated cases Isolated cases With foam Isolated cases Isolated cases Isolated cases Uncommon 0.1 % - < 1 % Isolated cases Isolated cases

21 Side effects of sclerotherapy European Guidelines Type of adverse event Benign Complications Visual disturbances Headaches and migraines Sensory nerve injury Chest tightness Dry cough Superficial phlebitis Skin reaction (local allergy) Matting Residual pigmentation Skin necrosis (minimal) Embolia cutis medicamentosa Frequency With liquid Not reported unclear Common Common Rare With foam Uncommon Uncommon Rare unclear Common Common

22 Benefits of liquid sclerosant Very good results in C1 veins Less neurological side effects Higher maximum volume possible (Pol 2 mg/kg body weight) compared to foam (10 ml of foam) For bigger GSV combination with mechanical damage of the intima maybe beneficial Less medico-legal questions where foam is not registered

23 More foam less liquid

[Kreussler Studies] FDA. multicenter GCP. controlled. randomized. prospective. blinded SUMMARY OF PIVOTAL STUDIES ON SCLEROTHERAPY OF VARICOSE VEINS

[Kreussler Studies] FDA. multicenter GCP. controlled. randomized. prospective. blinded SUMMARY OF PIVOTAL STUDIES ON SCLEROTHERAPY OF VARICOSE VEINS [Kreussler Studies] SUMMARY OF PIVOTAL STUDIES ON SCLEROTHERAPY OF VARICOSE VEINS FDA randomized controlled GCP blinded prospective multicenter [Sclerotherapy of Varices] Healthy legs with microfoam Chemische