1. Complications of sclerotherapy Saturday 09 March 2013 Pascal Giordana Nice, France.

2. expression of interest: No conflict

3. Sclerotherapy is an appropriate treatment for varicose veins. Sclerosant detergent modifies the venous wall and induces a local clot formation. In the long terme, successfully traited veins will be transformed into fibrous cords that cannot recanalize. P. Linser 1911 liquid J. Sicard 1916 liquid J. Orbach 1944 « air block » tehnique M. Schadeck 1995 ultrasound control sclerose for great and small saphenous varicoses. 1990’s (Cabrera, Monfreux)foam sclerotherapy

4. Cutaneous Subcutaneous Transfascial Varicoses veins Liquid Foam sclerosecomplications Erythema Pain (3%) Persistant swelling (2%) Matting and staining (3,9%) Cutaneous necrosis Transient migrainous scotomata Neurological events Superficial thrombophlebitis Deep venous thrombosis Recurrences 27% 1 year < 10% after

5. 12 173 sessions Sides effects are rares considering the billions of sessions performed Visual trouble: 0,25% (foam) vs 0,07% (liquid) Headaches and migraines X 7 with foam TIA or Strokes 5 cases DVT 0,09% to 1,8% Matting 4%

6. 818 GSV and 207 SSV were treated in 1025 patients in 20 phlebology clinics. 90,3% trunk were occluded (US control) 27(2,6%) side effetcs were reported and 14 (1,3%) complications: 8 migraines (4 with visual disturbance) 7 visual disturbance alone 7 chest pressure alone 5 chest pressure associated with visual disturbance 11 thrombo-embolic events 10 DVT (5 symptomatic) 1 pulmonary embolism (J19) 1 transiant ischémic stroke (30 minutes) 1 septicaemia

7. Review: 69 studies included, 9 000 patients. Foam sclerosant : 0,25% to 3%. Adverses events: DVT and PE < 1% Visual disturbance 1.4% Headache 4.2% Thrombophlebitis 4.7% Matting/skin staining and pigmentation 17.8% Pain at the site of injection 25.6%

8. Standardised 3% polidocanol foam is more efficient and equally safe compared to 3% liquid polidocanol for treatment of GSV

9. The most frequently complications: Skin staining (28%) Superficial thrombophlebitis (18%) Pain (14%) The only factor associated with post-UGFS complication was female gender (p<0,05). It was also significantly associated with skin staining (p<0,05) but no other complication This series failed to identify any major factor associated with complications following UGFS

10. Post sclerotherapy pigmentation Hyperpigmentation result from hemosiderin (FeO) accumulation. Hyperpigmentation and skin changes can be observed on US Intense pulse light generator equiped with radio waves under US control. 21 women: Hyperpigmentation was fully treated in 90.48% of patients and reduced in 9.52% 1.15 – 20% of sclerotherapy 2.Disappears within several months 3.Permanent in 10%

11. No necrosis when less than 0,5 ml is injected. Extravasation of polidocanol in usual circumstances of sclerotherapy of spider or reticular veins cannot be a signifiant cause of cutaneous necrosis. Particularly for the foam polidocanol form ( foam 2% vs liquid 1%). Post sclerotherapy cutaneous necrosis

12. Post sclerotherapy deep venous thrombosis and pulmonary embolism 1931 treatment sessions in 852 patients Ultrasound examination on the full length of axial deep veins above and below knee at J3 and J7. Deep venous thrombosis in 28 treatment sessions (1,45%) 16 distal DVT 12 proximal DVT 1 PE without DVT All asymptomatics The risk is lower: When using highly diluted sclerosant for vein less than 5 mm in diameter when foam injected volume was less than 10 ml.

13. Post sclerotherapy deep venous thrombosis and pulmonary embolism Polidocanol 1% 0.5 ml/injection US examination within 5 min (before compression) Control at day 3, 2 weeks, M1, M3 and M6 Foam was distributed significantly more commonly in the deep veins of patients treated with a few injection and a large volume (p= 0.0003)

14. sclerotherapy in patients with documented thrombophilia 105 patients: 75 factor V Leiden mutation 18 prothrombin 20210A mutation 7 Higth level of factor VIII 5 combinations of these 51 warfarin 54 LMWH 199 sessions (foam 160) No episodes of symptomatic DVT or PE. No DVT revealed by ultrasound-monitoring. No influence on the efficacity 1 large ecchymosis of the abdominal wall (LMWH) 2 post traumatic body ecchymose 3 thrombophlebitis Antiphospholipid syndrome and antithrombin deficiency are a contraindications to sclerotherapy.

15. Stroke? Case report: CEAP 4 GSV Foam 0,5% 20 ml. Type I diabete milletus, hypertension, hypercholesterolemia, asthma and migraine without aura. Mild expressive aphasia, right hemiparesis. Carotid duplex scan showed normal arteries. Transoesophageal echocardiogam revealed 18 mm patent foramen ovale with an atrial septal aneurysm.

16. Stroke Review 1023 articles of witch 41 studies. 10 819 patients undergoing sclerotherapy. 97 (0.90%) reports of neurological events (TIA, visual and speech disturbances) 29 (0.27%) reports of migraine 11 patients with TIA or CVA were found to have a right to left cardiac shunt (PFO) Neurological side effects following sclerotherapy are a rare occurrence Care should be exercised in patient selection, particulary in those with known cardiac defects.

17. Migraines and visual disturbances 11 patients Marked general ET-1 levels increased that correlated significatly with local ET-1 levals ET-1: Vasocunstriction cause of migraines Inotrope + Chronotrope +

18. Sclerose and dose Multicentre, propective, randomised, double blind 2 years-follow-up 148 patients (74 vs 74) GVS ≤ 8 mm Vol inject (4,6 ml vs 4,4 ml) 88% (1%) vs 96 % (3%) at 3 weeks 68% (1%) vs 69% (3%) 2 years No différences for adverses effetcs Multicentre, prospective, double-blind randomised trial 3 years-follow-up 143 patients [73 (1%) vs 70 (3%)] 69% (1%) vs 85% (3%) at M6 79% (1%) vs 78% (3%) at 3 years (complement M6) Pigmentation 6% (1%) vs 9% (3%) 3 asymptomatic thrombo-embolic events (2%)

19. With ou without compression? 60 patients Controls on days14 and 28 Abolition of venous reflux in 100% in both groups The lenght of occlusion was the same in both groups Symptoms and QOL questionnaires showed equivalent improvement in both groups side effetc was few with no statistical difference between the 2 groups.

20. Conclusion: 60 patients: 29 surgery: 78% succes at J 180 27UGFS: 90% succes at J 180 4 lost to follow-up Ultrasound-guided foam sclerotherapy is a safe and effective option for patients with chronic venous disorders

21. Conclusion: