How to prepare Sclerosing Foam. VAICON 2016 February 12th, 2016 Dr Serge MAKO

Transcription

1 How to prepare Sclerosing Foam VAICON 2016 February 12th, 2016 Dr Serge MAKO

2 Plan ØSclerosing agents ØBasics for a foam of high quality ØTo get a foam of high quality ØRules for foam sclerotherapy 2

3 Sclerosing agents Ø Sclerotherapy => damages the venous inner wall endothelium and leads to the destruction /occlusion of the varicose vein that is reduced into a connective tissue strand. Ø Efficacy depends upon concentration and the lasting of the contact between endothelium and agent. Ø Sclerosing foam obtained by mixing the active sclerosing agent together with air. 1- GUEX J.J., Complications and side-effects of foam sclerotherapy, Phlebology 2009 ; 24 : STÜCKER M. et coll., Review of Published Information on foam sclerotherapy, Dermatol Surg 2010; 36:

4 Sclerosing agents (2) Ø POLIDOCANOL & SODIUM TETRADECYL SULPHATE detergents used as liquid and foam surface-active biologically active when they form micelles in solution Effect dependent upon concentration very effective, reliable and safe stable clear liquids with low viscosity in the concentrations used for sclerotherapy 4

5 Sclerosing agents (3) Ø Chemical Differences They are different types of detergents Ø Pharmacological Differences In contrast to STS, POL is a local anaesthetic Ø Differences in the Mechanism of Action POL is more likely to act on phospholipid, STS more on protein parts of the cell membrane Ø Physical Differences POL produces a more stable foam than STS 5

6 Sclerosing agents (4) Clinical Differences Ø POL and STS are both very effective sclerosing agents Ø POL is more forgiving than STS Ø POL produces: Øless allergy and anaphylaxis; Øfewer and less severe complications such as necrosis and pigmentation. Ø STS can be painful upon injection Ø STS might be stronger in liquid form Ø POL foam and STS foam are supposed to be of similar potency 6

7 Sclerosing agents (5) ØPhysical properties of the foam allow: Filling of the varicose vein optimized, Larger contact surface and extended contact time between active agent and endothelium. => Foam does not mix with blood making a foam block On top of that a better echogenicity allows a better ultrasonic control. 7

8 Basics for foam of high quality Several parameters affect quality and stability of the sclerosing foams (3, 4, 5) : ØConnector type: to get a sufficient pressure in the system and a good mixing. ØSize of the syringes: 20 ml > 10 ml > 5 ml. ØPressure during the mixing and homogenization phases: Back & forth with compression down to 40-50% of the volume, back & forth without pressure. 3- Wollmann J.C., Phlebologie 2010; 39: Van Deurzen B. et coll., Dermatol Surg 2011 ; 37 : Peterson J.D. et coll., Dermatol surg 2011 ; 37 :

9 Basics for foam of high quality (2) Several parameters affect quality and stability of the sclerosing foams (3, 4, 5) : ØNature of the gas: a more stable foam in the syringe may quicker degrades in the body. ØRatio air/sclerosing agent: 1 vol. sclerosing agent + 4 vol. of air (1:4). ØSyringes: balance between stability smoothness of the injection. 3- Wollmann J.C., Phlebologie 2010; 39: Van Deurzen B. et coll., Dermatol Surg 2011 ; 37 : Peterson J.D. et coll., Dermatol surg 2011 ; 37 :

10 Basics for foam of high quality (3) A foam of «good quality» : Conclusion Ø Size of the bubbles: cohesive micro bubbles giving a compact foam. Ø Evolution of the bubbles over the time: direct transformation from micro bubbles state to liquid state without large bubbles state able to migrate towards the heart. Ø Stability: sufficient to allow injection of the compact foam. 10

11 In France, foam is registered since July ØFor Aetoxisclerol 2% and 3% Foam with Aetoxisclerol 0,25% and 0,50% has a shorter stability. ØRules of good practice became mandatory: To prepare sclerosing foam. To proceed sclerotherapy. 11

12 To get a foam of high quality General rules: ØSterile air or ambient air filtered on 0,2 µm. ØSelect the proper concentration for the sclerosing agent: 2% or 3%. ØVolume of syringes: 1 of 10 ml and 1 of 5 ml. The 5 ml one will be used for the injection. ØRatio air/sclerosing agent: 4 volumes of air for 1 volume of sclerosing agent. ØSafety of the connectors: luer-lock recommended. 12

13 To get a foam of high quality (2) General rules ctd.: ØBackward and forward movements: One move = transfer the complete content of syringe n 1 to syringe n 2 and reverse. Keep pressure inside the syringes: i.e. 9 ml of foam compressed down to 5 ml 10 to 12 move within 10 seconds. 13

14 To get a foam of high quality (3) General rules ctd.: ØMacroscopic aspect of the foam: To be checked before injection: must be compact, homogeneous, without bubbles visible at unaided eye (< 0,3 mm). If bubbles seen, foam must be prepared again. Good quality Poor quality 14

15 To get a foam of high quality (4) Ø0,2 µm filtered air: 1. Plug the connector to the syringe then the filter on the other end of the connector. 2. Aspirate the air through the filter (2 ml for 2,5 ml of foam). 3. Take 0,5 ml of sclerosing agent with the other syringe. 4. Disconnect the filter from the connector and immediately connect the syringe. 5. Make back-and-forth movements. 6. Check the quality of the foam before injection. 15

16 TAKE HOME MESSAGE ØVolume : < 1O ml ØQuality of foam : the bubbles should not be visible through the syringe ØRatio air / liquid 1: 4 ØSaphenous trunk treatment : polidocanol 1% 16

17 Rules for foam sclerotherapy ØTo be trained and master : ØOne hand for puncture-injection, other hand holds US probe. ØUS guided procedure to control the different steps: Øcheck and locate the vein; Øpuncture and proper positioning of the needle inside the vein to be treated; Ø control of the injection; Øcontrol post-procedure control. 17

18 ØSclerotherapy: Rules for foam sclerotherapy (2) ØSelect concentration of sclerosing agent according to type and diameter of the vein to be treated. ØSmall volumes of sclerosing agent to be injected on different sites along the vein if necessary. A spasm shows the action of the foam. ØCheck the complete filling of the vein. If necessary, complete with another injection. ØRespect the recommended does: 2 to 8 ml of foam per session, divided between different sites (0,1 to 2 ml per site). 18

19 ØSclerotherapy: Rules for foam sclerotherapy (3) ØSclerotherapy under strict asepsis conditions. ØSingle use devices. Remaining sclerosing agent or foam after the procedure must be discarded. ØFoam to be injected no later than 60 seconds after preparation. ØFor the injection of the foam prefer syringes with some silicone: smoother injection. ØUse 25G minima needles to inject foam: thinner needles damage the foam. 19

20 Thank you for your attention 20