Sclerotherapy using air- or CO₂-O₂-foam

Summary[*]

Introduction: This multicentre observational study (OS) documented the efficacy and side-effects of ultrasound-guided polidocanol foam sclerotherapy (FS) of air and carbon dioxide / dioxygen foam (CO₂-O₂ FS) using the same evaluation protocol in each centre.

Material and Methods: Eleven centers participated in this OS, nine centers worked with air-based FS, two with CO₂-O₂ FS. Only approved drugs were used. In 376 patients undergoing 553 treatments, air-based FS was performed using 0.25 % to 4 % polidocanol microfoam (Aethoxysklerol^®, Kreussler). 125 patients in 152 sessions were treated with CO₂-O₂-based foam using 1 % to 3 % polidocanol with seven parts CO₂ (Laparox^®, Linde) to three parts O₂ (Conoxia^®, Linde). For the sterile dispensing of the CO₂-O₂ FS a mass flow controller was used. Efficacy of treatment and side effects were assessed clinically and with duplex examination in the following visit and 4–6 weeks after the last session.

Results: Varicose veins larger than 3 mm were treated with an average volume of 5.3 ml in the air-FS and 8.2 ml in the CO₂-O₂ FS, p<0.0001. In the CO₂-O₂-group clinical appearance, and venous occlusion rate documented by Duplex treatment was slightly more efficient, most likely because larger volumes could be safely applied. In the CO₂-O₂ group compression therapy was performed in 97.6 % of the cases, in the air group and in 75.2 % significant (p=0.01).

In general more side effects occurred after air in comparison with CO₂-O₂ the differences were significant (p<0.0001) for: hyperpigmentation 23.3 %/13.6%, and he-matoma 14.4 %/2.5 %.

The differences were not significant for: Migrane 0.1 %/0 %, Matting 1.4 %/0 %, Burning sensation 11.7 %/5.5 %, Thrombosis 1.1 %/1.6 %, Visual impairment 0.2 %/2,0 %.

Keywords

CO₂O₂-Foam-Sclerotherapy - Air-Foam-Sclerotherapy - Efficiency - Side-effects - Visual side-effects

• Literatur

• 1 Almeide JI. Ultrasound-guided foam sclerotherapy. Endovascular today 2010; 33-35.
• 2 Beckitt T. et al. Air versus Physiological Gas for Ultrasound Guided Foam Sclerotherapy Treatment of Varicose Veins. Eur J Vasc Endovasc Surg 2011; 1e5
• 3 Bessereau J, Genotelle N, Chabbaut C. et al. Longterm outcome of iatrogenic gas embolism. Intensive care medicine 2010; 36 (07) 1180-1187.
• 4 Bessereau J, Coulange M. et al. Iatrogenic gas embolism after foam sclerotherapy?. Annales francaises d’anesthesie et de reanimation 2011; 13385-13385.
• 5 Blaise S. et al. Ultrasound-Guided Sclerotherapy of the Great Saphenous Vein with 1% vs. 3% Polidocanol Foam: A Multicentre Double-Blind Randomised Trial with 3-Year Follow. Eur J Vasc Endovasc Surg 2010; 39 (06) 779-786.
• 6 Breu FX. et al. 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee Germany. Vasa 2008; 37 (071) 1
• 7 Bush RG. et al. Major neurological events following foam sclerotherapy. Phlebology 2008; 23 (04) 189-192.
• 8 Cabrera J. et al. Treatment of venous malformations with sclerosant in microfoam form. Arch Dermatol 2003; 139 (011) 1409-1416.
• 9 Cabrera J. et al. In Mattassi R. et al. (Eds.) Hemangiomas and vascular malformations. Heidelberg: Springer; 2009: 171-179.
• 10 Cavezzi A. et al. Foam sclerotherapy techniques: different gases and methods of preparation, catheter versus direct injection. Phlebology 2009; 24: 247-251.
• 11 Ceulen RPM. et al. Microembolism during foam sclerotherapy of varicose veins. N Engl J Med 2008; 358: 1525-1526.
• 12 Coleridge Smith P. Chronic venous disease treated by ultrasound guides foam sclerotherapy. Eur J Vasc Endovasc Surg 2006; 32: 577-583.
• 13 Coleridge Smith P. Sclerotherapy and foam sclerotherapy for varicose veins. Phlebology 2009; 24: 260-269.
• 14 Christin F. et al. Paradoxical symptomatic air embolism after saline contrast transesophageal echocardiography Echocardiography. N.Y.: Mount Kisco 2007; 24 (08) 867-869.
• 15 Deichmann B. et al. Apoplektischer Insult nach Sklerotherapie. Phlebologie 1995; 24: 148-152.
• 16 Deurzen B VAN, Ceulen RP. et al. Polidocanol Concentration and Time Affect the Properties of Foam Used for Sclerotherapy. Dermatologic surgery 2011; 1-8.
• 17 Durandt TM. et al. The safety of intravascular carbon dioxide and its use for roentgenologic visualization of intracardiac structures. Ann Int Med 1957; 47: 191-201.
• 18 Eckmann DM. Polidocanol for endovenous microfoam sclerosant therapy. Expert Opin Investig Drugs 2009; 18 (012) 1919-1927.
• 19 Eklöf B, Rutherford RB, Bergan JJ. et al. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004; 40 (06) 1248-1252.
• 20 Forlee MV. et al. Stroke after varicose vein foam injection sclerotherapy. J Vasc Surg 2006; 43 (01) 162-164.
• 21 Frullini A. et al. High production of endothelin after foam sclerotherapy: a new pathogenetic hypothesis for neurological and visual disturbances after sclerotherapy. Phlebology. 2011: 1-6.
• 22 Genotell N, Bessereau J AD. Is it necessary to revalue the risk of a gas embolism complicating an intervention with carbon dioxide insufflation? Answer elements. Annales françaises d’anesthèsie et de rèanimation 2008; 27: 756-757.
• 23 Gillet JL. et al. Side-effects and complications of foam sclerotherapy of the great and small saphenous veins: a controlled multicentre prospective study including 1,025 patients. Phlebology 2009; 24 (03) 131-138.
• 24 Gillet JL. et al. Pathophysiology of visual disturbances occurring after foam sclerotherapy. Phlebology 2010; 25: 261-266.
• 25 Gloviczki P. Invited commentary. J Vasc Surg 2011; 53 (01) 137-138.
• 26 Guex J-J, Allaert F-A, Gillet J-L, Chleir F. Immediate and midterm complications of sclerotherapy: report of a prospective multicenter registry of 12,173 sclerotherapy sessions. Dermatologic surgery 2005; 31 (02) 123-128.
• 27 Guex J-J. Complications and side-effects of foam Sclerotherapy. Phlebology 2009; 24: 270-274.
• 28 Guex J-J. et al. The French Polidocanol Study on Long-Term Siede Effects: A Survey Covering 3,357 Patient Years. Dermatol Surg 2010; 36: 993-1003.
• 29 Jia X. et al. Systematic review of the safety and efficacy of foam sclerotherapy for venous disease of the lower limb. Brit J Surg 2007; 94 (08) 925-936.
• 30 Habegger R. et al. Lethal air embolism during arthroscopy. J Bone Joint Surg 1989; 71-B: 314-316.
• 31 Hahn M. et al. Late stroke after foam sclerotherapy. Vasa 2010; 39: 108-110.
• 32 Hamahata A. et al. Outcomes of Ultrasound-Guided Foam Sclerotherapy for Varicose Veins of the Lower Extremities: A Single Center Experience. Dermatol Surg 2011; 37: 804-809.
• 33 Hamel-Desnos C. et al. Liquid versus foam sclerotherapy. Phlebology 2009; 24: 240-246.
• 34 Hanisch F. et al. Stroke following variceal sclerotherapy. Eur J Med Res 2004; 9 (05) 282-284.
• 35 Hartmann K. Reversible neurological deficit after foam sclerotherapy. Eur J Vasc Endovasc Surg 2009; 38 (05) 648-649.
• 36 Hawkins IF. et al. Carbon dioxide (CO2) digital subtraction angiography: 26-year experience at the University of Florida. Eur Radiol 1998; 8 (03) 391-402.
• 37 Hlastala MP. et al. Absorption of in vivo inert gas bubbles. Respir Physiol 1975; 24 (02) 147-158.
• 38 Kas A. et al. Cerebellar infarction after sclerotherapy for leg varicosities. Presse Med 2000; 29 (035) 1935
• 39 Künzlberger B, Pieck C, Altmeyer P SM. Migraine Ophthalmique liquid 1% polidocanol. Dermatol Surg 2006; 32: 1410-1413.
• 40 Leslie-Mazwi TM. et al. Intra-arterial air thrombogenesis after cerebral air embolism complicating lower extremity sclerotherapy. Neurocrit Care 2009; 11: 247-250.
• 41 Linde Gas Therapeutics GmbH 85716 Unterschleißheim. http://www.linde-gastherapeutics.de Fachinformation/Zusammenfassung der Merkmale des Arzneimittels
• 42 Liu FC. et al. Hemodynamic changes caused by venous gas embolism in dogs: comparisons among air, carbon dioxide and oxygen. Acta Anaesthesiol Sin 2001; 39 (02) 71-76.
• 43 Ma RW. et al. Three cases of stroke following peripheral venous interventions. Phlebology 2011; 26 (07) 280-284.
• 44 Maeseneer M De. The endovenous revolution. The Br J Surg 2011; 98 (08) 1037-1038.
• 45 Morrison N. et al. Comparisons of side effects using air and carbon dioxide foam for endovenous chemical ablation. J Vasc Surg 2008; 47 (04) 830-836.
• 46 Morrison N. et al. Foamsclerotherapy : Cardiac and cerebral monitoring. Phlebology 2009; 24: 252-259.
• 47 Morrison N. et al. Incidence of Side Effects Using Carbon Dioxide-Oxygen Foam for Chemical Ablation of Superficial Veins of the Lower Extremity. Eur J Vasc Endovasc Surg 2010; 40 (03) 407-413.
• 48 Myers KA. Evaluation of published reports of foam sclerotherapy: what do we know conclusively?. Phlebology 2009; 24 (06) 275-280.
• 49 NICE Ultrasound-guided foam sclerotherapy for varicose veins Target date for publication of guidance: 2009 IPG ISBN 978–1–84936–065–4 N1978 1P.
• 50 O'Hare JL, Earnshaw JJ. The use of foam sclerotherapy for varicose veins: a survey of the members of the Vascular Society of Great Britain and Ireland. Eur J Vasc Endovasc Surg 2007; 34 (02) 232-235.
• 51 Palm MD, Guiha IC, Goldman MP. Foam sclerotherapy for reticular veins and nontruncal varicose veins of the legs: a retrospective review of outcomes and adverse effects. Dermatologic surgery 2010; 36 Suppl (Suppl. 02) 1026-1033.
• 52 Pannier-Fischer F, Rabe E. Epidemiology of chronic venous diseases. Der Hautarzt 2003; 54 (011) 1037-1044.
• 53 Parsi K. Paradoxical embolism, stroke and sclerotherapy. Phlebology 2011; 1-21.
• 54 Picard C. et al. Foam sclerotherapy: a possible cause of ischaemic stroke?. J Neurol Neurosurg Psychiatry 2010; 81: 582-583.
• 55 Plas van der JP, Lambers JC. et al. Reversible ischaemic neurological deficit after sclerotherapy of varicose veins. Lancet 1994; 8894: 428-428.
• 56 Rabe E. et al. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg 2008; 35 (02) 238-245.
• 57 Ramelet A, Monti M. Phlebologie. Fribourg: Verlag Masson 1988; 1990: 227
• 58 Rasmussen LH, Lawaetz M, Bjoern L. et al. 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.
• 59 Raymond-Martimbeau P. Outcomes of Ultrasound-Guided Foam Sclerotherapy for Varicose Veins of the Lower Extremities: Single Center Experience. Dermatol Surg 2011; 37: 810-811.
• 60 Regan J D. et al. Clinical significance of cerebrovascular gas emboli during polidocanol endovenous ultra-low nitrogen microfoam ablation and correlation with magnetic resonance imaging in patients with right-to-left shunt. J Vasc Surg 2011; 53 (01) 131-137.
• 61 Rush JE. More on Microembolism and Foam Sclerotherapy. N Engl J Med 2008; 359: 6
• 62 Sarvananthan T, Shepherd AC. et al. Neurological complications of sclerotherapy for varicose veins. J Vasc Surg 2011; 1-9.
• 63 Schuller-Petrovic S, Pavlovic M. et al. Subcutaneous injection of liquid and foamed polidocanol: extravasation is not responsible for skin necrosis during reticular and spider vein sclerotherapy. J Europ Acad Derm Ven 2011; 25: 983-986.
• 64 Shub C. et al. Detecting intrapulmonary right-toleft shunt with contrast echocardiography. Observations in a patient with diffuse pulmonary arteriovenous fistulas. Mayo Clin Proc 1976; 51 (02) 81-84.
• 65 Stautner-Brückmann C Passager. Halbseitensymptomatik nach Schaumsklerotherapie. Vasa 2009; 24: 131-138.
• 66 Stickland MK. et al. Intra-pulmonary shunt and pulmonary gas exchange during exercise in humans. J Physiol 2004; 1: 321-329.
• 67 Svenarud P, Persson M, Linden J van der. Effect of CO2 insufflation on the number and behavior of air microemboli in open-heart surgery: a randomized clinical trial. Circulation 2004; 109 (09) 1127-1132.
• 68 Wandrup JH. Quantifying pulmonary oxygen transfer deficits in critically ill patients. Acta Anaesthesiol Scand Suppl 1995; 107: 37-44.
• 69 Wollmann JC. Sclerosant foams Stabilities, physical properties and rheological behavior. Phlebologie 2010; 4: 208-217.
• 70 Wright D, Gobin JP, Bradbury a W. et al. Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial. Phlebology 2006; 21 (04) 180-190.
• 71 Wright DD. High prevalence of right-to-left shunt in patients with symptomatic great saphenous incompetence and varicose veins. J Vasc Surg 2010; 51 (01) 104-107.
• 72 Yamaki T. et al. Comparative study of duplexguided foam sclerotherapy and duplex-guided liquid sclerotherapy for the treatment of superficial venous insufficiency. Dermatologic surgery 2004; 30 (05) 718-722.