Ii foamer device presentation site 2015

Enric Roche MD , PHD

IS IT POSSIBLE TO IMPROVE TESSARI´S METHOD ?

ENRIC ROCHE, MD PhD. Director CLINICA VASCULAR BARCELONAChief Vascular service HOSPITAL UNIVERSITARI SAGRAT COR & HOSPITAL GENERAL DE CATALUNYARAMON PONS, QD Director INSTITUT QUÍMICA AVANÇADA , CONSEJO SUPERIOR DE INVESTIGACIONES CIENTÍFICAS ANTONI PUIG, MDCLINICA VASCULAR BARCELONA


I declare I haven´t any conflict of interest related to this presentation.


Several strategies to ablate Major and minor saphenas

TO STRIP BURN

ELECTRIFYBOIL

STICKEMBOLIZE

In your office,

Which % of Major/Minor saphenas are involved ?


Main concerns…

Foam sclerotherapy has great variability

about syringes material, three way stopcock, type of gas, ratio sclerosant /gas, fabrication system, injection system, strategy , temperature, patient position,

Safety is importantPhysiological gases are safer than air, specially when a large volume of foam is used Cabrera J, Patología Vascular. 1995; Wright D, Phlebology 2006; Morrison N. J Vasc Surg, 2008, Beckitt T, , Beckitt T, Eur J Vasc Endovasc Surg 2011., Hesse G, Phlebology 2012,

Versatility is a plusEasy to obtain a 1-2% stable foam …How many cases could be treated with high concentrations sclerosants ? What about foams less concentrated ( < 0,5% …)


FROTHER SYSTEM


OBJECTIVE:

To demonstrate the feasibility of a new system of standardized foam fabrication and its superiority in front of Tessari´s method in terms of stability and versatility.

MATERIAL AND METHOD

TESSARI´S METHOD -0,5% POLIDOCANOL Foam with AIR - 2% POL Foam with AIR - 2% POL Foam with O2/CO2 (50%/50%)

FROTHER-0,5% POLIDOCANOL Foam with AIR - 2% POL Foam with AIR - 2% POL Foam with O2/CO2 (50%/50%)


Tessari´s method: Two 10 cc (BD Brand – latex free ) with A three-way stopcock key ( B/ Braun) . A default 1/3 ratio was decided using 3 cc of POL / 9 cc of AIR or O2/CO2. ( O2/CO2 Experiments container was filled with gas bottle) After 20 passes Small amount In a slide for

measurements

Syringe left in a stand position for half-life calculation

MATERIAL AND METHOD

Foam measurements : Diameter of bubbles & Total foam volume A single layer of bubbles covered by a coverslip. Zeiss microscopy with a 2,5x with a Canon Power Shot 90S was used to take pictures. ( final magnification was 2428x1821 μm2 ) .Program used: ImageJ. Threshold particles analysis ( Size 150Infinity, Circularity 0,75-1)

Half –time life calculation: Was defined as Time necessary to get the half amount of sclerosant ( 1,5 ml) in a liquid state. (Total volume of sclerosant : 3 ml)Every 30 seconds was obtained a picture of the syringes in vertically placed position with a camera ( in a fixed position ) on a dark background.


PURESPUME or FROTHER system: Because the ratio liquid /gas is unknow is necesary to calculate previosly the sclerosant volume.Weight the syringe with 10 cc of foam / without foam in a precision scale3 ml of POL was frothed during 2 minutes ( 15sec-300rpm, 15 sec-700rpm,90 sec-1600 rpm) ( O2/CO2 Experiments container was filled with gas bottle)

After 2 min. in a slide

A sample was deposited In a slide for measurements

A stand position for half-life calculation

MATERIAL AND METHOD


RESULTSFrother system foam 2% POL AIR

Frother system foam 2% POL O2/CO2

Tessari´s foam 2% POL AIR

Tessari´s foam 2% POL O2/CO2


RESULTS 1. FOAM MEASUREMENTS - Diameter of bubbles- Total foam volume

% POL FROTHER SYSTEM TESSARI AIR O2/CO2 AIR O2/CO2

Diameter ED- σ Diameter ED-σ

0,5 %134±33μm 109±21μm 38±17μm 25±15μm

2 %104±22μm 74±22μm 65+/-20μm 51±20μm 40±20μm 40±15 μm

IC = 95%POL= PolidocanolED= Estandar deviation


RESULTS 1. FOAM MEASUREMENTS

% POL FROTHER SYSTEM TESSARI AIR O2/CO2 AIR O2/CO2

Diameter ED- σ Diameter ED-σ

0,5 %134±33μm 109±21μm 38±17μm 25±15μm

2 %104±22μm 74±22μm 65+/-20μm 51±20μm 40±20μm 40±15 μm

IC = 95%POL= PolidocanolED= Estandar deviation

- Diameter of bubbles- Total foam volume


RESULTS

FROTHER SYSTEM 2% AIR

Diameter range of FROTHER SYSTEM is lower than TESSARI’S FOAM

TESSARI´S 2% AIR Bubble Range: 25-150 µm Bubble Range: 25-245 µm


RESULTS

2. FOAM STABILITY: Half-time life

% POL FROTHER SYSTEM TESSARI´S FOAMAIR

minutesratio O2/CO2

minutesAIR minutes

O2/CO2 minutes

0,5% 6,5±3m 0,093 1/9 1,1±0,5m

2% 10,6±3m 0,089 1/10

2,2± 0,5m 2,0±0,5m 1,0±05m

IC = 95%

Statistical differences POL= PolidocanolRatio: Proportion of sclerosant/gas


RESULTS

2. FOAM STABILITY: Ratio sclerosant /gas

% POL FROTHER SYSTEM TESSARI´S FOAM

AIR O2/CO2 AIR or O2/CO2

0,5% 0,093 - 1/9 0,25 - 1/3

2% 0,089 - 1/10 0,14 - 1/6 0,25 -1/3

IC = 95%Statistical differences POL= Polidocanol

Ratio: Proportion of sclerosant/gas


RESULTS 2. FOAM STABILITY: Half-time life

FROTHER SYSTEM foam 2% AIR

Tessari´s foam 2% AIR


CONCLUSIONS

2. Tessari´s foam is more heterogeneous : although there are a very little bubbles

3. In our experiment frother´s foam is more stable than Tessari´s foam. (five times more stable compared to Tessari´s method when using air and twice when using a mixture of O2/CO2 )

4. 2% concentration of Polidocanol foam is more stable than 0,5% POL.

1. This system has demonstrated that it is useful in manufacturing foam with air as well as with a gas mixture of O2/CO2.


Comments

Our Tessari´s foam could be different than others foams

The standardization of parameters can be useful in offices where sclerotherapy is a common practice

Versatility is interesting in the office

Some Improvements have been necessary in order to request Health Authorities Approval


Thank you for your attention !!

Ii foamer device presentation site 2015

Health & Medicine

Transcript of Ii foamer device presentation site 2015